FDA OKs new drug for advanced prostate cancer        
The Food and Drug Administration said Friday it approved the pill Xtandi for men with advanced prostate cancer that has returned or spread despite major medical intervention.
          Selecting Nutritional Supplements        
Nutritional supplements can help compliment a diet that could be missing some necessary nutrients. But Nutritional supplements are only as good as the ones you select, and how you combine your Nutritional supplements with healthy food so that none of the nutrients are cancelled out.
An estimated 50 percent of American adults use Nutritional supplements regularly. But some doctors suggest that half of these adults aren't using these Nutritional supplements correctly.
So, how exactly is it possible to use Nutritional supplements incorrectly? Well, incorrect nutritional supplement use starts with a lack of understanding of these types of supplements. Too many people make the mistake of looking for bargain prices when they look for Nutritional supplements. The cheapest is rarely the best when it comes to Nutritional supplements.
People looking to add Nutritional supplements to their already fairly healthy diets should take the time and do some background research. Don't buy low-quality Nutritional supplements with little or no research behind them. And, unfortunately, a large percentage of the useless Nutritional supplements are those that put all their money into advertising instead of quality ingredients. These are the types of Nutritional supplements that are promoted as "popular" and often seem to be forever on sale.
When choosing a nutritional supplement, it's always better to choose a caplet over a tablet. The simple reason for this is that your body usually can't effectively dissolve a tablet nutritional supplement. And if your body can't dissolve this type of nutritional supplement, then it won't be able to breakdown the ingredients and feed the nutrients to different parts of your body. Plus, the super low-quality Nutritional supplements rarely dissolve at all. Studies of these types of Nutritional supplements show that the entire whole form of the tablet can sit in your stomach like a tiny stone for many, many hours. So always select a capsule nutritional supplement. It's much nicer to your digestive system and much better for you body.
Avoid single-nutrient Nutritional supplements. Single-nutrient foods don't exist, so why would you feed your body single-nutrient Nutritional supplements? Eating these types of Nutritional supplements will only succeed in ruining the balance of your body's chemicals.
And don't try a "piecemeal" approach to nutritional supplement use. A piecemeal approach is when you select a variety of single- or multiple-nutrient Nutritional supplements, and mix-and-match them to try and make up for where you think your diet lacks. Few people have the skills to do this type of nutritional supplement maneuvering.
When selecting Nutritional supplements look for ones that say they are "laboratory tested." Laboratory tested Nutritional supplements means that they've been created by responsible manufacturers who choose to follow the FDA regulations, even though they're not required to do so.
Pick Nutritional supplements that are "quality guaranteed." Quality guaranteed Nutritional supplements are ones that use pharmaceutical-grade products.
Be wary of Nutritional supplements that claim to be 100 percent natural. A 100 percent natural nutritional supplement, just like 100 percent cobra venom, is probably not good for you. And always make sure every nutritional supplement container you buy has an expiry date. Nothing stays good forever, not even Nutritional supplements.

Looking for the Lactose Free Whey Protein?
Click here for the Best Lactose Free Whey Protein!!!
For more Defense Nutrition Products click HERE.

          Supplements And Nutrition        
A well-balanced diet and affinity for all food groups ensure right amounts of much-needed nutrients. However, not all people are blessed with a liking for vegetables or tolerance for milk. There are also people with allergies to nuts and poultry which are excellent sources of protein and good fat. What if you are one of them? How can you be sure that you get proper nutrition without force-feeding yourself brocollis? This is why Supplements and Nutrition should work together.
Before taking supplements, it would be wise to seek your doctor's advice. After all, you want to be sure to have the proper Supplements and Nutrition. The wide variety of supplements include multivitamins, protein supplements, minerals, and specialized supplements. Multivitamins are the most prescribed supplements. Regulated and concentrated amounts of essential vitamins are packed in a tablet or gels. Protein supplements are commonly used by people who want to build more muscle such as athletes. Mineral supplements include calcium for bone growth. Dietary supplements and memory enhancers are commonly classified as specialized supplements.
Supplements and Nutrition must be complementary. For example, a person who consumes large amounts of carrots and squash need not take a supplement of Vitamin A. This is because too much of Vitamin A can cause a yellow or orange tinge to the skin. Other overdoses on minerals and vitamins can even disrupt normal hormonal function. After all, even too much of a good thing can be hazardous to health.
Hence, a proper Supplements and Nutrition scheme must be discussed with the doctor in order to prevent overdoses or taking unnecessary supplements. The US FDA in recognition of the growing market and need for supplements has taken steps to regulate the production, dosage, and sanitation of supplements. This was done to ensure good-quality products. This move is also partly due to rising number of unprescribed supplement use among consumers. The agency also stressed the importance of informed use among supplement users. It is not enough to know the name of your supplements. You should know what deficiency it corrects and how it works. Studies show that many use different supplements whereas tests done to them indicate only a minimal lack which can be corrected by a single kind. Also, despite the supplement rage, doctors and health experts still stand by natural correction of deficiencies by means of a proper diet. They suggest eating alternative sources of nutrients found in allergy-inducing foods. Hey, real food tastes better than capsules anyway.

Looking for the Lactose Free Whey Protein?
Click here for the Best Lactose Free Whey Protein!!!
For more Defense Nutrition Products click HERE.


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          ê°ê¸°ì•½ 내성으로 계속 반복! 면역증강으로 감기졸업        



돌 이후로 어린이집을 다니면서 서로 주고받는(?) 바이러스 환경에 노출이 되면서,

콜록콜록 감기를 달고 살던 제임스인데요.


그러다가 작년인 2015년 1월 1일 폐렴에 한 번 걸리면서,

그 이후로는 항생제 복용의 반복이었습니다. 쩝 ㅠㅠ





아무리 신경을 쓰고 또 써도,

매번 열을 동반한 코감기에 한 번 걸리면 꼭 항생제로 끝나다 보니,

이러지도 저러지도 못해서 최근까지도 너무 마음이 안좋았습니다.

(사실 이 글을 쓰기 직전까지도 ì œìž„스는 감기약을 복용했습니다. ㅠㅠ)





엄마로써 정말 큰 관심을 갖고,

항생제 없이 키울 수 있는 방법을 찾기 위해 오감세가 오랫만에 공부를 했습니다.


세 아이의 아버지이자,

16년간 15,000명 이상의 영유아의 면역 증강을 위한 근본치료를 한

성모아이한의원의 김성철 한의사님이 쓰신 책을 만나게 되면서 ì•„이 건강에 대한 고민이 많은 부분에서 ë„움이 되었습니다.





그동안 이 엄마, 저 엄마, 그리고 인터넷에서 주워들었던 이야기들을 총정리한 느낌이라고 할까요?

감기에는 치료약이 아직 없다라는 말을 수 없이 들어봤는데,

아이에게 먹이는 약이 정확히 어떤 역할을 하고 있는지 많은 정보를 얻게 되었습니다.





책에서 계속 강조하는 내용은,

우리 아이가 먹고 있는 감기약과 항생제는,

아이가 겪고 있는 증상에 따른 불편함을 보다 편하게 도와주는 화학약품일 뿐,

아이의 면역력 측면에서 봤을때는 근본적인 치료가 아닐뿐만 아니라,

면역력이 제대로 발휘될 기회가 없어 오히려 감기를 이겨내는 íž˜ì´ 길러지지 않게 된다는 논리입니다.





영유아들에게 가장 흔하게 발병되는,

열감기, 코감기, 축농증에 오감세도 굉장히 집중해서 정독을 했습니다.





굉장히 인상적이었고,

엄마로써 와 닿았던 내용은,


수도 없이 반복되는 감기와 싸우느라 성장에 필요한 에너지를 소비하는 바람에,

이러한 잔병치례와 면역력의 감소는 아이가 성장하는데 굉장히 큰 타격을 준다는 것입니다.


이건 정말 실제 아이를 키우는 엄마로써 와닿는 내용이고,

실제로 오감세의 마음을 크게 움직였습니다.





감기가 발병되는 원인은 굉장히 다양하지만,

체질에 따라 치료하는 방법 또한 다양합니다.


모든 사람에게 홍삼, 도라지가 좋은것이 아니라는 내용도 눈여겨 봐야할 부분입니다.


오감세처럼 몸이 찬편인 사람에게는 확실히 도움이 되지만,

열이 많은 우리 아들에게는 맞지 않을 수 있다는 것이죠.


하지만 이런부분들은 엄마혼자 판단하기는 힘들고,

전문 한의사에게 진료를 받아야 합니다.





또, 깜짝 놀랄만한 감기에 대한 정보도 책에서 확인할 수 있었습니다.


우리가 감기라고 생각하는 유아 감기에는,

소화불량일 가능성이 있음도 알았습니다.


즉, 오한을 동반하지 않는 발열일 때 집에서 응급조치로,

일단 손발을 따 주고, 공복을 취하는 것이 좋다고 합니다.


해열제 역시 무조건 미열때부터 먹이는 것이 아니라,

(세균과 면역세포가 싸우는 활동이므로 바로 해열제를 먹이는 것은 옳지 않다라고 합니다.)

최대한 화학성분의 양약을 복용하지 않을 수 있도록 조치를 취해본 후,

그래도 고열로 인해 고통스러워할 때 해열진통제를 소량 복용하는 방식으로요.


즉, 화학성분의 양약은 최대한 신중히 투여해야한다는 것입니다.





특히, 책에서 ì¶©ê²©ì ì¸ 데이터를 봤는데요.

외국과 한국의 영유아에 대한 약처방에 대한 차이를 확인할 수 있습니다.


미국 FDA 자문위원회는 2007년 만 2시 미만 영유아들에 대한 OTC감기약 사용중단을 권고하였고,

영국/캐나다/호주/뉴질랜드에서는 만 6세 미만 소아에게 OTC 감기약의 판매를 제한하는 조치를 시행했다고 합니다.


여기서 OTC는 'over the counter'의 약자로 의사의 처방 없이 살 수 있는 의약품을 의미합니다. 즉, 약국에서 쉽게 구입할 수있는 일반 의약품과 유사한 개념이죠.





책을 처음부터 거의 후반부까지 읽은 상태인데요.

아이에게 신중히 약을 투여해야함은 물론,

면역력을 올려 스스로 이겨낼 수 있는 힘을 길러줘야 함에 전적으로 동의를 하게 되었습니다.


책을 읽기 전까지는 그냥 그렇다던데... 그래야 한다던데.. 정도로 막연했었는데,

구체적이고 확인된 데이터를 보며 공부해보니,

우리 아들에게 정말 필요한 보살핌이 어떤 것인지 알게 되었습니다.


무분별하게 약을 투여할 것이 아니라,

아들의 체질에 맞게 근본적인 치료를 돕고, 면역력을 키워줘야 겠다라는 생각이 강하게 들더라고요.



병원 또한 분명 삶에 있어서 없어서는 안될 기관이고,

실제 도움을 많이 받아왔습니다만,

현재 작년 이후로 제가 봐도 면역력이 너무 떨어진 아들을 위해,

지금부터라도 면역증강에 더 집중해야겠다고 굳게 다짐해봤습니다.




아이를 키우는 자녀분들이라면,

오감세가 읽은 "감기졸업"이라는 이 책을 적극 추천합니다.


다양한 민간요법에 대한 정보도 있고,

화햑약품에 대한 정보도 알고 계시면 엄마들의 선택에 큰 변화가 있을 것이라 생각됩니다.

정말 많은 부분에서 도움이 되었습니다.




실제로 오감세는 이 책을 읽고,

많은 부분에서 진심으로 공감을 하게 되어,

다른 한의원이지만 오랫동안 오감세가 도움을 받아온 한의원에 ì²˜ìŒ 아들을 데리고 가서 ì„¸ì‹¬í•˜ê²Œ 진찰을 받고 왔습니다.

올해부터는 우리 아들도 몸 속에서부터 건강이 우러나오는 아들이 되도록 엄청 힘 좀 쓸 거랍니다.


오늘도 감동인 세상 오감세였습니다.

건강하고 행복한 하루 되세요~ ^^









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          Top 5 reasons to love your SCOBY        
Andrea's gift
Andrea's Gift
This post is something of an experiment. While SEO (Search Engine Optimisation) has become a bit of a dirty word in blogging recently, I believe there's nothing wrong with making cosmetic changes that increase the chance that people will find and read what you have to say.

One kind of post title that people appear to like promises a list of reasons for something. I've been meaning to write a post about the joys of the fermentation community for a while, and the original title of this post was "It takes a village to grow a SCOBY". But I'm going to use the list format, instead. Tell me whether you like it and I should do more of them, or you think it is just gimmicky.

Just to remind you, a SCOBY is a Symbiotic Colony Of Bacteria and Yeast. The acronym usually refers to the culture used in making kombucha, but milk kefir and water kefir grains are also SCOBYs. Yoghurt cultures are not.

5. While there isn't much scientific proof of the benefits of fermented drinks such as kombucha and kefir, there is plenty of anecdotal evidence that people with gut issues who drink kombucha seem to feel better. That is certainly true in my case. There was a scare a few years ago in which the FDA linked deaths to kombucha, but there doesn't seem to have been any conclusive evidence there. I've never felt ill after drinking my home-brew. It's also a great source of B vitamins. Of course it is important to make sure everything is clean, etc. - well, duh. They haven't warned people off Pepsi yet, because, you know, it doesn't do anything bad to you.

4. Even if you, like me, can't drink cultured milk directly, you can still make wonderful dairy products with it. I made the most amazing cultured butter from local organic milk I had fermented with milk kefir grains. It tasted just as good as the store-bought butter brought in from Quebec, and was considerably cheaper, which you can't always say for home-made stuff. Just as an aside, if I were able to access raw milk in Manitoba it is entirely possible that I would be able to drink the milk kefir. Again, there hasn't been much scientific research but I've heard many anecdotal reports of people who were supposedly intolerant of dairy doing just fine with the unpasteurised version. Again, you need to make sure everything is clean and safe. Well, duh.

3.  There is something very magical about watching the slow transformation of sweet tea into something resembling cider. You plop your little alien-looking colony into the tea, cover the jar and put it in a warm place. After about a week you will have a new baby SCOBY to share with your friends, and a yummy drink to put into bottles for a second fermentation with fruit or herbs. I usually use blueberries, strawberries or ginger. It's incredibly delicious. Even if it didn't have a single health benefit, it just tastes so nice, especially first thing in the morning. Move over, grapefruit juice.

2. It does take patience, whether you are making kefir or kombucha. You can't hurry it up, although you can slow it down by keeping it in a temperature that is too low. I usually put my jar in the oven with just the light on (and a BIG sign on the door to prevent me from cooking my ferments!). Having to wait on nature is good for the soul in these frenzied times. It can be quite zen.

1. Best of all, you get to interact with an amazing community of fellow enthusiasts. You can't buy a SCOBY in the supermarket. There are websites out there which will sell one to you, but it is much more fun to get one from a local person. I was fortunate to be put in touch with a lovely lady named Andrea, who gave me my first kombucha SCOBY. I am so grateful to her, and to Sarah who gave me milk kefir grains. I was fortunate to be able to pass on some of my baby SCOBYs to others interested in travelling a similar route. You can't buy that kind of experience, either.

So, those are my top reasons for loving my SCOBYs. I'm sure I could come up with more, but I don't want the blog post to be too long. What do you think?
          Support the CREATES Act, S. 974 and H.R. 2212        

On behalf of FreedomWorks’ activist community, I urge you to contact your representative and ask him or her to support the Creating and Restoring Equal Access To Equivalent Samples (CREATES) Act, S. 974 and H.R. 2212. This bill would lower prescription drug prices by crushing illegal, anti-competitive, and monopolistic practices by the biggest pharmaceutical companies.

Prescription drug prices have soared above general inflation rates for years, a telltale sign of lacking producer competition. Large moneyed pharmaceutical companies abuse a loophole in the FDA Amendments Act of 2007 that allows them to bar potential competitors from entering the market. They do this by refusing to provide drug samples and safety information that new producers need for medical research required in the FDA approval process of generic drugs.

Without these samples and safety procedures, new producers never earn FDA approval. Meanwhile, existing producers establish monopolies and hike prices.

This especially harms the emerging market for “biosimilars,” innovative remakes of biologic drugs. Biosimilars are often much cheaper to produce than name-brand biologics, reducing costs for millions of Americans.

The CREATES Act would grant relief in court for generic and biosimilar competitors seeking FDA approval. This would clear the pathway for new drugs to enter the market, drastically reducing prices through increased competition. The cost savings stemming from this legislation could reach between 15 percent and 50 percent of current prices for impacted drugs.

Such legislation would reduce both the federal deficit and national debt. Decreasing prescription drug costs would lessen the financial burden on Medicare, saving taxpayers up to $5 billion annually.

As you know, FreedomWorks fights for free markets and smaller government. The CREATES Act would lead to a freer market, less cronyism, and cheaper medication. For these reasons, I urge you to contact your representative and ask him or her to support the CREATES, S. 974 and H.R. 2212.


Adam Brandon, President, FreedomWorks

          Congress Should Lower Ridiculous Drug Prices by Passing CREATES Act        

Perpetually increasing prescription drug prices ravage everyday Americans. Specifically, name-brand prices outpace inflation by about 50%, largely due to government-protected market power. A beacon of hope for reducing drug prices are the generic and biosimilar drug industries, which produces existing brand drugs and biologics drugs through distinctly cheaper methods. But big Pharma doesn’t want competition, so it does everything it can to block generic and biosimilar innovation. The CREATES Act, H.R. 2212, solves a loophole commonly abused by big pharmaceutical companies for unlawful market advantages in the emerging generics and biosimilars markets.

Existing drug companies exploit the Food and Drug Administration’s (FDA’s) Abbreviated New Drug Application (ANDA) requirements for FDA approval of competitive generic and biosimilar products. This is an unlawful tactic to increase market-power. Biosimilars are a type of biologic drug – drugs manufactured from living cells – that mimic both the composition and the function of an existing biologic drug but employ cheaper production processes. Tragically, established producers prevent aspiring competitors from completing ANDA.

To complete a generic or biosimilar approval process, applicants must acquire sample drugs from existing producers. This allows medical researchers to demonstrate that the functions and properties of the original brand drug and the new generic or biosimilar are, in fact, equivalent. Sadly, many brand companies refuse to provide samples to potential competitors, preventing them from gaining approval. Thus, innovative generics and biosimilars hit the market less frequently, trapping consumers with fewer options and higher prices. While this practice of abusing distribution networks is illegal, there are no enforcement mechanisms preventing it.

Remember the damnable pharmaceutical executive Martin Shkreli, who raised the price of a biologic AIDS drug Daraprim by over 5000% in one night? One of his profit-protection methods was to deny competitor applicants the samples they need to earn FDA approval. Competing with losers like Shkreli would be easy it if weren’t for this loophole. High school chemistry students reproduced Daraprim for less than $2 a pill compared to Shkreli’s $750.

A similar monopolistic scam employed by entrenched pharmaceutical companies involves exploiting shared Risk Evaluation and Mitigation Strategy (REMS) procedures. Producers of existing brand drugs are sometimes required by the FDA to establish safety protocols that protect consumers from safety risks. The FDA encourages companies to share, or streamline, their REMS procedures for maximum safety and congruency among user experiences. If a person taking biologic drug X switches to biosimilar drug X, the shared procedure is supposed to ensure that there are no major differences in how this person safely consumes the drug. In a similar fashion to denying samples, big pharma often refuses to share REMS procedures. When a REMS program has previously been required, FDA cannot approve a generic or biosimilar until a shared REMS has been negotiated or the agency has been given sufficient evidence to waive the requirement. This imposes redundant and costly burdens on biosimilar producers, and ultimately delays market entry for far less expensive but equally safe drugs.

Both of these tactics, refusal to share samples and failure to fairly negotiate shared REMS programs, establish de facto monopolies for original drug producers, but they’re easily fixed by the CREATES Act. Under the CREATES Act, generics and biosimilar manufacturers will be able to seek injunctive relief in court against companies that withhold samples or REMS information. This will improve competition with new generics and biosimilars, reducing prescription drug costs possibly as much as 40%. It will also help sustain Medicare Part D, the national deficit, and debt, by reducing government drug expenses by up to $5 billion per year.

Congress should end illegal monopolies and help Americans afford their medications by passing the CREATES Act, all without increasing the size of government.

          Capitol Hill Update: July 24, 2017        


The House and Senate are in session this week.

There are five (5) legislative days remaining for the House before the August recess and 53 legislative days remaining in the year. The Senate will supposedly work through the first two weeks of the August recess.


The FY 2018 budget resolution, dubbed "Building a Better America," was marked up and approved by the Budget Committee on Thursday in a party-line vote. The budget would reduce the budget deficit by $6.5 trillion over the ten-year budget window and eventually come into balance in FY 2027, creating a $9 billion surplus.

Perhaps one of the most important components of the budget is that it begins the reconciliation process for fundamental tax reform. There are also reconciliation instructions for 11 House committees to find roughly $200 billion savings or reforms in mandatory spending.

The FY 2018 budget resolution isn't on the calendar for the week. It's unclear if House Republican leaders will bring it to the floor.

Additionally, the 21st Century Aviation Innovation, Reform, and Reauthorization (AIRR) Act, H.R. 2997, introduced by Transportation and Infrastructure Committee Chairman Bill Shuster (R-Pa.) could come to the floor for a vote this week. The bill reauthorizes the Federal Aviation Administration (FAA) and reforms the United States' out of date air traffic control (ATC) system. FreedomWorks has released a key vote in support of the 21st AIRR Act.

On Monday, the House will consider 17 bills on the suspension calendar. Most of the bills on the suspension calendar related to veterans or active military issues. There are three bills on the suspension calendar that relate to small businesses and investment. The House will also consider the Intelligence Authorization Act, H.R. 3180, sponsored by Intelligence Committee Chairman Devin Nunes (R-Calif.) on suspension.

There are three bills on the suspension calendar for Tuesday, including the Medicare Part B Improvement Act, H.R. 3178, sponsored by Ways and Means Chairman Kevin Brady (R-Texas), and a yet-to-be-numbered resolution that will impose sanctions on Russia, Iran, and North Korea.

The House will also consider H.J.Res. 111, a resolution of disapproval under the Congressional Review Act, to cancel the Consumer Financial Protection Bureau's (CFPB) giveaway to trial lawyers. The rule put restrictions on the use of arbitration to settle disputes over consumer products. This would lead to more class-action lawsuits, benefiting trial lawyers and hurting consumers. FreedomWorks has signed a coalition letter in support of H.J.Res. 111 and will likely include the vote on our 2017 Congressional Scorecard.

For the balance of the week, the House will consider at least four more bills on the suspension calendar. The Make America Secure Appropriations Act, H.R. 3219, will also come to the floor. This is the consolidated appropriations bill, or "minibus," for the Department of Defense, the Legislative Branch, Military Construction and Veterans Affairs, and Energy and Water. Like virtually every other bill to come to the floor this year under "regular order," the Make America Secure Appropriations Act is subject to a rule to limit or prevent amendments from the floor.

On Thursday at 10:00 am, the Judiciary Committee will hold a hearing entitled "The Need for the Balanced Budget Amendment." The witness list for the hearing has not yet been announced. Twelve constitutional amendments have been introduced in the House that would require a balanced budget. Chairman Bob Goodlatte (R-Va.) is the sponsor of two of them, H.J.Res. 1 and H.J.Res. 2. Rep. Justin Amash (R-Mich.), the primary sponsor of H.J.Res. 15, is among the House conservatives who have introduced a balanced budget amendment.

The committee and subcommittee schedule for the week can be found here.


Presumably, the Senate will vote this week on the motion to proceed to the House-passed version of H.R. 1628. It's still unclear on what happens next. A vote to proceed to the House-passed version has always been the first step. The next step will be for an amendment to the bill that will substitute the language of either the Better Care Reconciliation Act or language similar to the 2015 ObamaCare repeal bill, now called the ObamaCare Repeal Reconciliation Act. FreedomWorks' key vote on the motion to proceed applies only if the base text that will be substituted is similar to the 2015 ObamaCare repeal bill.

At least a few Senate Republicans have backed away from their votes for the 2015 ObamaCare repeal bill, which was passed in December 2015 with the support of all but two Republicans, including Sen. Susan Collins. Moderate Republicans who refuse to vote for the 2015 ObamaCare repeal bill have demanded $200 billion in Medicaid funding offered by Majority Leader Mitch McConnell (R-Ky.) to get them to support the Better Care Reconciliation Act.

Some parts of the Better Care Reconciliation Act are in limbo, however, as the Senate parliamentarian has apparently ruled that provisions limiting funding for Planned Parenthood and tax credits for plans that cover abortion will require 60 votes. Other provisions that may require 60 votes include the State Innovation Waivers. Many of these provisions can be altered to make them withstand a Byrd rule challenge, as was done in 2015.

The Senate still has several nominees to consider and, on the legislative front, the FDA Reauthorization Act, S. 934; the National Defense Reauthorization Act; and the debt ceiling are among the items awaiting action.

Separately, Senate Democrats are rolling out their "better deal" economic agenda today, which is a rehashing and repackaging of virtually every leftist policy proposal in recent years. The agenda is Democrats' attempt to find a message after a string of special election losses around the country.

The full committee schedule for the week can be found here.

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          Celltrion/Teva and Amgen/Allergan Announce FDA Submissions for Proposed Biosimilars of Herceptin®        

          FDA Reauthorization Act of 2017 passes the House        

          Merck Receives Tentative FDA Approval for Lantus Follow-on        

          Termografía para la detección de Cáncer de Seno.        

Termografía para la detección de Cáncer de Seno.

Esta también llamada ‘termografía de pecho', ó termomastografía tiene la habilidad de descubrir las primeras señales que indiquen que un cáncer puede estarse formando, incluso 10 años antes de que cualquier otro procedimiento pueda detectarlo.

Desde 2006 el Centro de Estudios y Prevención del Cáncer A.C. (CEPREC), está evaluando esta novedosa e innovadora prueba. Este hecho, lo convierte en el único centro con ésta tecnología en el país: una cámara de rayos infrarrojos que al captar el calor de la mama permite detectar alteraciones tempranas.

Su ventaja es que no produce radiaciones, no es dolorosa y su sensibilidad para detectar el cáncer de mama es hasta el 94%.

"Este estudio, en combinación con la mastografía convencional de rayos X y la mastografía digital nos ayudará a diagnosticar el cáncer de mama en etapas más tempranas, aumentar la supervivencia y reducir la mortalidad por este tumor", aseguró a rotativo de Querétaro el Dr. Francisco Gutiérrez Delgado, director del CEPREC en Juchitán, Oaxaca.

El Dr. José G. Vázquez Luna, profesor investigador de la BUAP empleó la tecnología militar e hizo transferencia a la medicina, diseñando un sistema capaz de registrar ondas que registran calor.

El antecedente de ésta tecnología está en la investigación militar, durante la vigilancia nocturna de tropas. El calor de los cuerpos de los soldados enemigos, delata su posición a kilómetros de distancia. Con éste sistema se detecta, registra y produce imágenes de la superficie de la piel de los senos y es posible correlacionar los puntos de calor detectados con el tamaño del tumor. "El cáncer exige al cuerpo que lo alimente, existe un proceso de angiogénesis cuando se inicia el cáncer, es decir, se crean nuevos vasos sanguíneos que llevan alimento al tumor.

Este fenómeno de formación de nuevos vasos sanguíneos resulta revelador porque incrementa localmente la temperatura. Con la termografía se pueden detectar estos pequeños incrementos locales de temperatura.

La imagen térmica se convierte en un inmejorable coadyuvante, que el médico con otro grupo de pruebas determinará si es o no cáncer". "Es una prueba fisiológica que puede detectar cambios mínimos de temperatura, la termografía puede usarse como pesquisa o prueba discriminatoria, es decir, si una mujer pasa primero por esta prueba y no se localiza ningún riesgo no tendría caso exponerla a la masto grafía, y si se encuentra alguna anormalidad entonces con apoyo de la masto grafía y/o ultrasonido se lograra un certero diagnóstico" reveló el doctor en física.

El Investigador de la Escuela Físico Matemáticas de la BUAP, expuso que el principio físico es sencillo: La energía térmica ó infrarroja, por su longitud de onda, no es visible por el ojo humano, pero la termografía, por medio de una cámara, "ve" y "mide" la energía infrarroja que está siendo emitida por un objeto.

La capacidad de emisión de la piel humana es muy alta, por lo tanto, la radiación infrarroja emitida puede ser convertida a valores de temperatura. José G. Vázquez Luna, en entrevista para este medio, también explicó que existen más de 1200 estudios, incluidos en el Index Medicus que han evaluado su rol en la detección temprana del cáncer de mama. "En 1982, la FDA aprobó la termografía de pecho como un procedimiento válido para la detección de cáncer de mama, sin embargo, la termografía de pecho ha sido profusamente investigada desde 1950.

En más de 30 años de investigación se han reunido mas de 800 estudios en el área y se encuentran en la literatura médica. En esta base de datos, más de 300,000 mujeres se han incluido como participantes del estudio, algunos estudios han seguido a los pacientes a lo largo más de 12 años y se sabe que se han establecido estrictos protocolos de interpretación estandarizados durante mas de 15 años.

La termografía de pecho tiene una media sensibilidad y especificidad de 90%" argumenta Vázquez Luna. La literatura médica reporta que un termograma anormal es 10 veces más significativo, como un indicador de riesgo futuro de cáncer de mama, que un antecedente familiar de primer orden.

Un termograma anormal persistente incrementa 22 veces el riesgo de desarrollar en el futuro un cáncer de mama. Una imagen infrarroja anormal es por sí sola, el marcador mas importante de riesgo de desarrollar cáncer del pecho.

Cáncer de mama, un asunto nuestro: físico y oncólogo

El físico José G. Vázquez Luna y el oncólogo Francisco Gutiérrez Delgado comparten la certeza: Diariamente se diagnostican 26 casos nuevos de cáncer de mama. Y es que el cáncer de mama ocupa el segundo lugar como causa de muerte por tumores en el sexo femenino.

Esta situación es agravada por el insuficiente personal de salud entrenado para educar a la población femenina y el escaso equipo radiológico especializado (mastógrafos), el cual se concentra solamente en las grandes ciudades del país, el resultado es que 8 de 10 mujeres con cáncer de mama se diagnostican en etapa avanzada, prácticamente cuando cualquier tipo de tratamiento es ineficaz y 11 mujeres mueren diariamente por esta enfermedad.

"Evaluamos el rol de la termomastografía de nueva generación en la detección temprana del cáncer de mama en población abierta del Istmo de Tehuantepec. Este estudio tiene una sensibilidad y especificidad alta para el diagnóstico de patología de la mama (85%) aseguró su director, el Dr. Francisco Gutiérrez Delgado, especialista Oncología y Doctor en Ciencias Médicas.

"Cuando se utiliza con otros métodos Autoexploración, Ultrasonido y mastografía, se puede detectar hasta el 95% del cáncer.

Diversas investigaciones ha mostrado que la termografía de pecho aumenta significativamente la tasa de supervivencia de las mujeres hasta en un 61%".

Explicó también que las ventajas del termógrafo, es su elevada productividad ya que se pueden realizar mas de 10 termomastografías por hora con cada termógrafo, y como es un equipo ligero, puede ser desplazado a comunidades alejadas y municipios de todo el país, donde los servicios médicos no existen o son precarios.

El Dr. Gutiérrez Delgado es Fellow del American Collage of Physicians (FACP), miembro de la American Society of Clinical Oncology (ASCO), European Society for Medical Oncology (ESMO), y American Society for Blood and Marrow Transplantation (ASBMT) y sostiene que el objetivo del Centro, es educar a la población mexicana en una nueva cultura que incrementa el interés por la salud y que prioriza la prevención sobre la curación.

Fuente: http://rotativo.com.mx/?module=displaystory&story_id=6666&format=print

Is Breast Thermography Safe?

Breast thermography is very safe. There is no exposure to radiation or any compression of the breast tissue.

Es la Termografía segura?

La termografía de seno es muy segura. No hay exposición a radiaciones ó ningún tipo de compresión del tejido mamario.

How is Breast Thermography different from a Mammogram?

Both tests are looking for completely different signs of breast cancer. Thermography looks for changes that occur as a growing cancer alters the blood supply of the breast and changes the physiology and chemical environment of the tissue of the breast. Mammograms look for changes to the density of the breast that indicates the presence of a tumor. Mammography identifies the physical. The medical literature views both procedures as complimentary to each other.


Conf Proc IEEE Eng Med Biol Soc. 2007;2007:3312-4.

González FJ.Infrared imager requirements for breast cancer detection.

PMID: 18002704

Ann Acad Med Stetin. 2006;52(1):35-9; discussion 39-40.

Mikulska D.Contemporary applications of infrared imaging in medical diagnostics

PMID 17131845

Surg Technol Int. 2005;14:51-6.Agnese DM.Advances in breast imaging.

PMID: 16525954

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          Rihanna : La nudité et la provocation sont à la mode...        
Rihanna aux CFDA Fashion awards. Ceci c'est de la
provocation de haut niveau, on ne peut pas faire mieux
que ça en terme de perversion sexuelle.
C'est devenu une mode dans le showbiz aujourd'hui, ils font tout pour dé-sacraliser le corps sacré de la femme, la femme est une créature sacrée, la maternité est également une chose sacrée que Dieu a donné a la femme, mais Satan, par le biais de ses célébrités/stars, fait tout ce qui est en son possible pour anéantir le côté sacré des femmes.
Je veux aussi que les femmes, vêtues d'une manière décente, avec pudeur et modestie, ne se parent ni de tresses, ni d'or, ni de perles, ni d'habits somptueux, mais qu'elles se parent de bonnes œuvres, comme il convient à des femmes qui font profession de servir Dieu. (1 Timothée 2:9-10)
Des filles possédées comme Rihanna travaillent avec des hordes de démons pour détruire l'archétype féminin. Il faut arrêter de se bercer d'illusions, nous sommes dans un conflit primordial qui oppose les forces des ténèbres aux forces de la lumière, Rihanna a choisit le camp des ténèbres contre la gloire éphémère de ce monde. Elle est donc aujourd'hui un outil des ténèbres pour la destruction des bonnes valeurs morales d'autrefois. Ces célébrités travaillent tellement bien que les gens vous diront : "Bof! Ecoute, tu es un rétrograde, le monde évolue." Rihanna, comme beaucoup d'autres célébrités, échouent au test du Seigneur, lorsqu'il demande de ne pas inciter les hommes à la convoitise sexuelle:
Vous avez appris qu'il a été dit: Tu ne commettras point d'adultère. Mais moi, je vous dis que quiconque regarde une femme pour la convoiter a déjà commis un adultère avec elle dans son cœur. (Matthieu 5:27-28)
Ces stars passent le temps à exhiber leurs corps nus, sous le regard émoustillé des gens. Les gens qui regardent ce genre de pourritures sont autant coupables que les stars eux-mêmes. Les photos de Rihanna que je vais vous montrer sont choquantes, mais il faut que vous voyez ces gens dont se nourrissent vos enfants à la télévision. Il faut que vous les voyez sous leur réelle apparence afin de prendre une décision dans vos vies. J'ai mis ces photos dans ce lien-ci, âmes sensibles, abstenez-vous, ici nous présentons l'oeuvre des esprits qui pilotent Rihanna pour la perte de l'humanité.

Il ne suffit pas de savoir que Rihanna et compagnie sont des illuminati et consort, ce qui est le plus important c'est de prendre position par rapport à ce fait, il faut mettre des limites quelque part, je ne peux pas dire que j'ai la Foi en Dieu mais je continue à écouter les musiques d'une femme qui de manière évidente travaille pour la perte de l'humanité, il faut choisir son camp tout de suite, c'est une question de vie ou de mort éternelle. Pour que nous soyons à l'image de notre Créateur, nous devons lui ressembler, pour lui ressembler, il faut connaitre sa parole et la mettre en pratique, sa parole qui est contenue dans la Sainte Bible. Nous devons donc l'imiter également lorsqu'il dit:
"Je ne mettrai rien de mauvais devant mes yeux; je hais la conduite des pécheurs; elle ne s'attachera point à moi." (Psaumes 101.3)
Il vous faut vous repentir!
          Rebuttal: Botched Executions        
Rebuttal: Botched Executions 
Dudley Sharp

To: Professors and Staff, Georgetown Law School
       and Georgetown Law Journal 

RE: Rebuttal:  Facing the Firing Squad, ANDREW JENSEN KERR, 104 Geo L.J. Online 74 (2016)

Note: This rebuttal applies to any of the related writings by Austin Sarat
From: Dudley Sharp 

I hope this helps Kerr and the Law Journal to vet a little better. 

It appears that lethal injection executions are "botched" about 1% of the time, not 7%.

 The vast majority of the "botched" executions are no such thing.

The majority of the false "botched" claims are attributed to multiple needle pricks and/or problems with the murderer's veins.

Everyone familiar with lethal injections and other IV procedures knows that multiple needle pricks are a responsible and necessary function to avoid "botched" executions or botched medical IV use. 

Multiple needle pricks are 1) not "botched" executions, but represent a common, normal safety practice with all IV procedures, daily and worldwide, 2) preparation for the execution, not the execution, and 3) often required to have secure needle insertion and retention.

 It would be negligent not to go through that procedure, the opposite of "botched". 

The entire process of looking for good veins is to prevent "botched" executions. Once good usable , secure veins were found,  the executions proceeded.

 It is the opposite of "botched". 

Other, wrongly, identified "botched" executions are when the murderer is gasping for breath, coughing, etc., which are the expected, known outcomes of respiratory distress, common effects with these drugs, whose effects are well known to  include . . . .  respiratory distress, (1) with very few of those incidents having any evidence to show consciousness or pain. 

Other false claims of "botched" executions are cases where the murderer is making noise, jerking, having spasms, etc., well known in cases of drug overdoses, which is, precisely, what we are dealing with (1) - drug overdoses are what lethal injections are -  with zero evidence of consciousness or pain. 

These are the well known side effects of the drugs used, not "botched" executions. 

In addition, many of  the sources for alleged "botched" are media, which, completely, blew the reality of the Arizona execution of Wood and the Ohio execution of McGuire cases, two infamous "botched" executions (2). 

These were not botched executions, but just took a long time to die, as expected, with no evidence of any consciousness or pain (2). 

What happens when an author doesn't fact check their sources and their sources are media that don't fact check? Will anyone rely on those sources or the conclusions drawn from them? 

"(Wood's execution) doesn’t actually sound like a botched execution. This actually sounds like a typical scenario if you used that drug combination,” said Karen Sibert, an anesthesiologist and associate professor at Cedars-Sinai Medical Center. Sibert was speaking on behalf of the California Society of Anesthesiologists." (2). 

Both of those executions are included in "botched" execution claims, only because folks depended upon inaccurate media reporting and did not fact check them. 

Kerr writes: " The desiccated market for  this anesthetic has forced U.S.  wardens to shop for off- brand  pharmaceuticals in  places  like  India or  U.S.  state regulated  “compounding”  pharmacies,  where  standards  of  quality  control  might  be lacking." 

"Might" is irrelevant. Facts are relevant. Quality control might not be lacking. 

Denno brings up, constantly, the 2012 meningitis outbreak at a compounding pharmacy, as if that is representative of compounding pharmacies. 

Has there been one case of improperly compounded drugs used in an execution? No. 

Somehow, that was left out of the article. 

Has Kerr or Denno considered how many innocent people have died and or been injured, in the US, since 1973, because of errors by non-compounding pharmacies and because of the FDA and the drug companies approving drugs that were, later, found to be deadly or injurious? 

My educated guess is that it is way over 100,000 innocents dead, with countless injured (2). Why don't they check  out "medical misadventures" (3), finding up to 400,000 innocent patients dying, every year in the US, due to such "misadventure" (3).

I am speaking of innocent patients, not guilty murderers. 

Has it been shown that compounding pharmacies are a less reliable source for execution drugs than other sources? Not that I am aware of. 

Did Kerr review the medical literature on the overdosing properties of all the drugs being used for executions? It appears not. 

Does Kerr understand that those properties are the same, whether in an execution setting, or not? 

The properties of the drugs don't, all of a sudden, magically, change, when they are used in lethal injection. 

This, below, indicates that Kerr is unaware. 

Kerr writes:    " . . . in  the  post Baze world of midazolam and other off brand substitutes the trigger  anesthetic  might  fail  to sedate  the  executed." 

"Might" is not a fact. Factually, all the cases Kerr is  speaking of were sedated.

 Kerr writes: "  . . . the anti epileptic drug  pentobarbital has even  been repurposed to replace  sodium  thiopental. The  deleterious  consequences  of  these  kinds of  substitute  compounds  are  exacerbated  by  the  tranquilizing  effect  of pancurium  (the  second  drug  of  the  traditional  three part  cocktail)." ""The feint here is that in the botched injection this muscle relaxant can mimic a look of serenity on the face of the executed, when they are in fact experiencing the visceral terror of their “whole body burning. It is the orca’s false smile of Blackfish." "the terrific pain of the botched lethal injection remains masked". "The executed person’s musculature is too incapacitated to reflect the existential pain of cardiac arrest. Instead, the mask of  the  executed  is inflected  as a  performance of dignified  passing  for  the execution audience. " 

Such fiction. Such drama. Kerr has no evidence to support his claims.

Texas uses a one drug protocol,  pentobarbital and has had no problems. 

What evidence does Kerr have that those states, which use  pentobarbital, first, and pancuriun, second, have had any problems with that protocol? None.

Is Kerr aware that those two drugs, used together, may increase the potency or effects of both? 

Kerr fails to tell us why and how the first drug, which causes unconsciousness just, all of a sudden, decides, on its own, to stop being effective, and thus, somehow allows the murderer to become conscious, even though such is not possible, with the drugs known characteristics, at the dosages given.


Kerr could not have botched this more. 

Kerr, also, botched the physician's "do no harm" oath.

"(D)o no harm" is not part of the Hippocratic Oath (5) and is, only, specified with regard to patients (5), in another document.  Death row inmates are not patients. 

The Hippocratic Oath bans physician participation in both euthanasia and abortions (5), practices which countless physicians participate in, millions of times per year, without any complaints from the AMA or any concern for the Hippocratic Oath. 

There is no death penalty ban in that oath. 

The AMA seems to only follow the Hypocrisy Oath. 

Alternate Executions Options

All states need to seek an exception for lethal injection drugs, from both DEA and FDA control, so the states can used whatever they find to be the best alternative.

The single drug, lethal injection  protocol with penatobarbitol seems to work very well.

Fentanyl maybe the best alternative. 

"The researchers asked the respondents to describe what happened during a suspected fentanyl overdose. The most common characteristic, described in 20 percent of the cases, was that the person's lips immediately turned blue, followed by gurgling sounds with breathing (16 percent of the cases), stiffening of the body or seizure-like activity (13 percent), foaming at the mouth (6 percent) and confusion or strange behavior before the person became unresponsive (6 percent), according to the report." (6)

Sound familiar? Sounds and body movement.

Nitrogen Gas

The alternate method for execution in Oklahoma and Alabama is nitrogen gas, by far the most foolproof method, when looking at 1) the fewest things that can go wrong, 2) the total lack of pain for the executed murderer and 3) it cannot be withheld or restricted (3). All organs are useful in the very off chance the murderer wishes to donate viable organs or their body to science. I agree that the firing squad is a responsible option. 

1)  There are a lot of medical writings on these issues. Here are just two. 

Opioid Drug Use and MyoclonusPosted in Physical Health

Opiates and Sleep-Disordered Breathingby Barry Krakow, Sleep Dynamic Therapy | Nov 12, 2015

2) No "Botched" Execution - Arizona (or Ohio)

3) see Do MORE Harm: The Anti Death Penalty Solution

 within The Death Penalty & Medical Ethics Revisited

4) Nitrogen Gas; Flawless, peaceful, unrestricted method of execution

5)  see THE ETHICS OF LYING - The Hippocratic Oath 

within The Death Penalty & Medical Ethics Revisited

6) Here's What Happens During a Fentanyl Overdose, Sara G. Miller, LIVESCIENCE, April 13, 2017


          FDA approves world's first GMO fish: fast-growing Atlantic Salmon        

atlantic salmon

In a landmark decision more than two decades in the making, the US Food and Drug Administration announced its approval of a genetically modified Atlantic Salmon variant on Thursday. The AquAdvantage salmon, which was initially developed back in 1989 and submitted for approval in 1995, grows far faster than its conventionally bred brethren. The FDA has deemed it safe for human consumption, equally nutritious as other salmon varieties and not dangerous to the environment. And since the GMO salmon is considered nutritionally equivalent to regular salmon supermarkets will be able to carry the fish without having to label them being GMO.

Via: Mother Jones, Ars Technica

Source: US FDA

          FDA Walks a Fine Line on E-Cigs        

WASHINGTON -- The U.S. Food and Drug Administration (FDA) appears to be performing a complicated balancing act with electronic cigarettes, at once easing rules by delaying deadlines for manufacturers to apply for new-product approval while also tightening its grip by announcing a new education campaign designed to deter youth from vaping.

The FDA announced Aug. 8 that it would pursue what it called “a strategic, new public-health education campaign aimed at discouraging the use of e-cigarettes and other electronic nicotine delivery systems (or ENDS) by kids.”

In a press release, the agency said it plans this fall to expand its “The Real Cost” public-education campaign to include messaging to teens about the dangers of using these products, while developing a full-scale campaign to launch in 2018. It is the first time the FDA will be using public-health education to specifically target youth use of e-cigarettes or other ENDS.

The announcement comes about a week after the FDA said it would delay the August 2018 deadline for manufacturers of ENDS products to submit FDA-approval applications, pushing the date back to August 2022. It’s a move that many in the tobacco industry saw as positive.

“While we pursue a policy that focuses on addressing the role that nicotine plays in keeping smokers addicted to combustible cigarettes, and to help move those who cannot quit nicotine altogether onto less harmful products, we will also continue to work vigorously to keep all tobacco products out of the hands of kids,” said Dr. Scott Gottlieb, commissioner of the FDA.

Addressing the schedule it announced in July, the agency said it will put nicotine and the issue of addiction at the center of its efforts.

“This policy aims to strike a careful balance between the regulation of all tobacco products and the opportunity to encourage development of innovative tobacco products that may be less dangerous than combustible cigarettes,” the agency said in a statement. “But, importantly, the approach also continues to focus on the need to reduce the access and appeal of all tobacco products to youth, including e-cigarettes and other ENDS, and maintains all of the existing regulations that currently apply to these products.”

Angel Abcede

Catheter Research, Inc. (dba Thomas Medical, Inc.) Honored as One of the 2012 Indiana Companies to Watch

(Indianapolis) – Catheter Research, Inc. has been recognized as one of the 2012 Indiana Companies to Watch, an awards program presented by the Indiana Economic Development Corporation, its Small Business Development Center and the Edward Lowe Foundation.
Twenty-five companies from Indiana will be honored as outstanding second-stage companies during the fifth annual Indiana Companies to Watch awards program, held on August 23 in Indianapolis.

Companies to Watch is an awards program that celebrates Indiana’s privately held second-stage companies, typically those businesses that are past the startup phase, are considered to be established, and face issues of growth, not survival.

Companies honored range in industries and have headquarters based in 13 counties throughout the state. Among the 25 honored companies in 2012 is Catheter Research, Inc.

About Catheter Research, Inc.

Located in Indianapolis, Indiana, Catheter Research, Inc. (CRI) is a market leader in medical device manufacturing, contract development, and product life cycle management. CRI specializes in catheter design /assembly, medical tubing /extrusion, and OBGYN Disposables. CRI provides excellence in project management, lean manufacturing techniques, supply chain controls, and regulatory compliance. CRI’s quality system has been designed to tailor processes to meet the diverse requirements of customers, in an ever changing regulatory and economic environment. CRI is an ISO 13485 certified manufacturer and FDA Registered.

CRI is the parent company of Thomas Medical, a distributor of OBGYN Products and Surgical Instruments. CRI/Thomas Medical is 100% owned by a workforce of 120+ employees who participate in the employee stock ownership plan (ESOP).

About Indiana Companies to Watch
Companies to Watch firms must employ between six and 150 full-time equivalent employees, have between $750,000 and $100 million in annual revenue or working capital in place, and demonstrate the intent and capacity to grow based on employee or sales growth, exceptional entrepreneurial leadership, sustainable competitive advantage or other notable strengths.

This year the program attracted more than 160 nominees and applicants. From that pool, 63 finalists were selected, and 25 companies emerged to become the 2012 class of Indiana Companies to Watch.

This awards program is unique because of its focus on second-stage companies. The impact of these companies on Indiana’s economy is tangible. During 2007-2009 Indiana’s resident companies averaged more than 32,000 second-stage establishments according to YourEconomy.org, an online resource of the Edward Lowe Foundation. Those second-stage companies employed an average of more than 773,000 workers during the period of 2007-2009.

Looking at the contributions of these companies from a different perspective, from 2007-2009 only 9.2 percent of Indiana’s resident establishments were in the second-stage category, however, they generated 37.2 percent of jobs in the state.

This program would not be possible without the generous support of Barnes & Thornburg LLP as well as Premier Capital Corporation, Katz, Sapper & Miller, KeyBank, Miles Printing and Purdue University. The program is also supported by Ivy Tech Corporate College and media sponsors BizVoice magazine, Inside Indiana Business and Northwest Indiana Business Quarterly.

About the program presenters:
The state of Indiana’s lead economic development agency, the Indiana Economic Development Corporation oversees Indiana’s statewide business attraction and development efforts, coordinates state programs, and incentives for companies looking to grow in Indiana, and provides assistance and funding to Indiana entrepreneurs and high-tech start-ups.

The Indiana Small Business Development Center Network offers free and low-cost strategic assistance for growth oriented entrepreneurs and businesses with less than 500 employees. Funded in part by the federal and state government, the ISBDC is focused on growing the economy through small businesses.

The Edward Lowe Foundation inspired the creation of the Companies to Watch program to celebrate second-stage entrepreneurs and their companies. Established in 1985, the Edward Lowe Foundation is a Michigan-based nonprofit organization that supports entrepreneurship through recognition, education and research with a focus on second-stage companies—those that have moved beyond the startup phase and seek significant, steady growth. The foundation also encourages economic gardening, an entrepreneur-centered strategy providing balance to the traditional approach of business recruitment.



Catheter Research Inc. (CRI) specializes in catheters and tubing, and has expanded as a developer and manufacturer of medical devices. Our goal is to provide the most cost-effective product development combined with quality OEM medical device manufacturing. ISO 13485:2003.

With complete solutions for design, development, and manufacturing processes within the medical devices industry, CRI is a leading medical product developer and manufacturer of medical devices.  CRI provides its customers with unbeatable service, excellent quality control and regulatory compliance. Located in Indianapolis, Indiana, CRI is a top Midwest medical device manufacturer and employs 100+ people. In 2008, CRI began the process to become an employee-owned business with a 30% ESOP acquisition. In December 2010, CRI became 100% employee owned company.

Customer Focus
CRI has a dedicated staff focused on being the internal advocates for all of our customers to ensure a high level of satisfaction. The customer service staff follows up on all customer requests for timely action and responses. All customer feedback and questions are entered into a tracking database within hours of receipt. The system includes a follow up loop and closure after the feedback is addressed. The feedback is categorized and trended for improvements and preventive measures to be put in place if needed. CRI has an annual goal of 98% on time delivery, and has met this goal consistently.

Project Management

CRI has an excellent track record with project management. Each new customer is assigned a dedicated project manager, to ensure effective and timely communication. This includes operating to a plan and schedule, with reporting on deliverables and budget attainment. Project Management is used for new design, design changes and manufacturing transfer programs.

  • Device Review
  • Document Review
  • Manufacturing Transfer
  • Inventory Transfer
  • Inventory Control
  • Project Cost Estimates
  • Budget & Delivery Tracking

Quality Tools and Regulatory Excellence

CRI has developed and implemented a state of the art Quality Management System, combining both simplicity and regulatory compliance. This system includes a Quality Manual consisting of only 3 pages, which is the road map for all of our employees to follow, to stay on track within the system. You will find this roadmap hanging in all areas, as a quick reference to procedural guidance. The document numbering system is designed to allow for quick retrieval and reference to quality procedures, manufacturing and inspection procedures, work instructions and forms. All new hires at all levels receive FDA QSR (GMP) and ISO13485:2003 training within their first week, ensuring critical requirements are understood. This training is repeated quarterly to re-emphasize critical objectives.
  • Fully integrated ERP system
  • Risk management
  • Fully compliant calibration and preventive maintenance system
    • Includes all fixtures and tooling
    • Equipment
    • Gages
    • Scales
    • Dispensing apparatus
  • Six Sigma and lean methodologies
  • Statistical sampling techniques - AQL, C=0, etc.
  • Process capability measurement - Cpk, Ppk, etc.
  • Process validations (IQ/OQ/PQ)
  • Sterilization Validations (ETO / Gamma)
  • Cost containment
  • Design control & documentation
  • Process yield / defect analysis
  • Process control (SPC)
  • Project Management
  • Formal corrective / preventive action
  • Material traceability systems
  • Precision measuring gages
    • Microscopes
    • Micrometers (digital / laser)
    • Pin gages, block gages
    • Calipers
    • Profile projector
    • Instron tensile and compression tester
    • Tubing burst test systems - high pressure
    • Pouch burst testers
    • Leak testing equipment
    • Other various precision gages
Engineering and Design

CRI’s engineering department offers an extensive and diverse background in all phases of engineering design and development.  We specialize in medical device disposables, from concept stage through final Medical Packaging and distribution, with 80% of our business being contract manufacturing of Medical Disposables and other devices. We focus on design for manufacturability, with emphasis on creating repeatable, controlled processes and high functioning devices for our customers.  Our internal areas of expertise include:

  • Ultrasonic welding
  • RF welding
  • Plasma treatment
  • Pad printing
  • Heat forming
  • Balloon bonding
  • Insert molding
  • UV / CA & solvent bonding techniques
  • Swaging
  • Medical Packaging
  • Sterilization validations
  • Tooling for high volume throughput
Supply Chain Management

CRI's supply chain management is designed to manage and control the most difficult piece for anyone's business. Controlling quality, delivery and responsiveness at the supplier level is not only critical, but is becoming the primary focus for all regulatory bodies, including FDA and ISO13485:2003. Our innovative process provides for excellence to meet not only the regulatory requirements, but to ensure customer's needs are met consistently. This includes a comprehensive feedback system for suppliers and partnering with suppliers for combined excellence and rewards.
  • Focus on economic order quantities based on price, delivery and storage costs.
  • Minimal obsolescence with excellent communication to customers.
  • Change management agreements including multiple department approvals at critical suppliers.
  • Utilizing MRP system for ensuring on time deliveries to meet customers due dates.
Fulfilment and Distribution 

  • Negotiated tariffs with multiple freight companies
  • Goal is 100% fill rate with 98% on time delivery
  • Annual re-negotiation process with freight companies to keep costs down
  • 99.9% accuracy in shipping and customer documentation
  • 99.9% damage free shipments 
CRI has implemented an extrusion and tubing line for flexible PVC, single lumen, medical Tubing; with a focus on quality and short lead-times.
CRI is committed to the highest quality medical tubing and strong customer service.  We have invested in state-of-the-art extrusion and tubing manufacturing equipment to insure a “robust” extrusion process and we have a highly skilled and dedicated extrusion team.
Let CRI assist you with the production of plastic tubing and extrusion that will meet your exact requirements and exceed your expectations.
Our capabilities include:

  • Quality System compliance to: FDA QSR 21 CFR Part 820 and ISO 13485, 2003
  • Flexible Polyvinyl Chloride (PVC) Extrusion
  • Medical Tubing 
  • Gas Sampling Lines
  • High Volume Extrusion
  • Diameter Ranges: .040 ID and .750 OD
  • Installation Qualifications (IQ)
  • Operational Qualifications (OQ)
  • Performance Qualifications (PQ)
  • Reeled (coil) Tubing
  • Cut-to-Length
  • Precision Tolerances
  • Short Lead-times
  • Closed-looped Measurement System
  • In-process & Final Inspection
  • Statistical Process Control (SPC)
 Manufacturing and Transfers

CRI takes a team approach to transferring manufacturing lines into our facility. We assign a dedicated Program Manager at the start, to ensure all deliverables are documented and tracked. We focus on improving process and product during the transfer, resulting in lower costs and improved quality. CRI also minimizes the effort for our customers, making transfers seamless and smooth.
  • Class 8 cleanroom facility
    • 1920 square feet
    • ISO certified
  • Controlled environment
    • all production working areas
  • Lean manufacturing
    • maximizing customer value while minimizing waste
    • resulting in lower and controlled costs
      • Evaluate all aspects of process
      • Eliminate non-value added steps
      • Minimize process steps
      • Less human efforts, less space, less cue times, less waste, less inventory
      • Single piece flow
      • Reduces errors and improves visualization of process
      • Reduces errors and improves visualization of process
  • Visual manufacturing
    • Organized work centers and processes
    • Indicators at all stages of process for status
  • Fully integrated MRP system
    • Utilizing M2M software for all aspects of business
    • Bar coding
    • Automated manufacturing processes and cost analysis by product
  • Document Control
    • Our document control process includes all regulatory requirements for this critical area of our Quality Management System. This includes lock out of documents pending changes, to ensure implementations are compliant and that errors are prevented. The final stage of document control includes training and effectiveness measurement.
      • Fully implemented change control system for all documents for a fully compliant Quality Management System
      • Device Master Records (DMR)
      • Device History Records (DHR) for all lots manufactured
      • Document control process tracked for quick change turn around
      • Standards library always kept up-to-date

          FDA panel favors Pfizer's new arthritis drug        
Federal health advisers said Wednesday that a first-of-a-kind drug from Pfizer appears to be safe and effective for patients with rheumatoid arthritis, though they recommended follow-up studies to gauge the pill's long-term side effects.
          I wish every Trump voter would read this article ... by gimleteye        

Why the Scariest Nuclear Threat May Be Coming from Inside the White House

Lots of Trump voters had become disaffected by the dysfunction of Washington DC and believed a "disrupter" had a better chance at positive reform as any conservative GOP candidate. We tried to warn you.

Trump turns out to be exactly the president that extremists wanted; one who would tear apart the functions of executive authority and radically realign regulatory matters in the hands of the states. 

As Michael Lewis points out for Vanity Fair, there are many critical functions of the federal government that are necessary to the health and security of all the American people, and that these functions rely on capable, qualified civil servants.

Lewis points out the tragedy unfolding as a result of the Trump presidency; only halfway through his first year. Trump's indifference and incompetence has crushed the personnel ranks of the Energy Department, now headed by the most clueless appointee in the agency's history, former TX Gov. Rick Perry. (Ukrainian pranksters recently engaged Perry in a half hour discussion broadcast to the world. He thought they were representatives of the Ukrainian prime minister. Oh well.)

The same disintegration of talent and expertise is happening in other federal entities: from the State Department to the US EPA and Department of Interior, from the FDA to the USDA. Trump said he would "drain the swamp". Nothing could be further from the truth.

He has created a viper's nest of influences in the White House, all competing for his attention from one second to the next. Meanwhile, the functions of the federal government are crumbling. The GOP Congress is not lifting a finger.

It is a dangerous world, Trump supporters have made it much, much more dangerous.

          The Future of AI: Redefining How We Imagine        

FICO 25 years of AI and machine learning logo

To commemorate the silver jubilee of FICO’s use of artificial intelligence and machine learning, we asked FICO employees a question: What does the future of AI look like? The post below is one of the thought-provoking responses, from Sadat Nazrul, an analytic scientist at FICO, working in San Diego.

Looking at the next 20 years, I see us moving well beyond the productivity enhancements AI has brought about so far. With the advent of AI, we will be seeing a renaissance in our own personal lives as well as society as a whole.


Today, our gadgets have the ability to monitor the number of steps we take, the rate of our heart beat, as well as the contents of our sweat. All this rich information allows a team of doctors, engineers and analysts to monitor our well-being and to maintain our peak performance. Similarly, with innovations in genomic sequencing and neural mapping passing FDA trials, we will soon be seeing huge leaps in the field of personalized medicine. AI will help us understand individual physiological needs in order to come up with customized prescriptions and improve our overall health standards.

Cognitive Abilities

People are keen to improve cognition. Who wouldn’t want to remember names and faces better, to be able more quickly to grasp difficult abstract ideas, and to be able to “see connections” better? Who would seriously object to being able to appreciate music at a deeper level?

The value of optimal cognitive functioning is so obvious that to elaborate the point may be unnecessary. Today we express ourselves through art, movies, music, blogs, and a wide range of social media applications. In the field of image recognition, AI can already “see” better than we can by observing far more than the RGB. Virtual Reality allows us to feel as though we have teleported to another world. New idioms of data visualization and Dimensionality Reduction algorithms are always being produced for us to better experience the world around us.

We are constantly trying to enhance our 5 senses to go beyond our human limits. 10 years from now, these innovations, coupled with IoT gadgets, will act as extensions of who we are and help us experience our surroundings more profoundly.

Emotional Intelligence

Just as we enhance our 5 cognitive senses, so too do we enhance our ability to express ourselves and to understand those around us.

Many times, we don’t even know what we want. We strive to connect with those around us in a specific way or consume a particular product, just so we could feel a very unique emotion that we fail to describe. We feel much more than just happiness, sadness, anger, anxiety or fear. Our emotions are a complex combinations of all of the above.

With the innovations in neural mapping, we will better understand who we are as human beings and better understand the myriad emotional states that we can attain. Our complex emotional modes will be better understood as we perform unsupervised learning on brain waves and help find innovative ways to improve our emotional intelligence. This would include both understanding our own emotions and being more sensitive towards those around us.

Perhaps we can unlock new emotions that we have never experienced before. In the right hands, AI can act as our extensions to help us form meaningful bonds with the people we value in our lives.

Experience and Imagination

The effect of AI on our experience and imagination would result from an aggregate of better cognitive abilities and emotional intelligence. The latest innovations in AI may help us unlock new cognitive experiences and emotional states.

Let’s imagine that the modes of experience we have today is represented in space X. 10 years from now, let’s say that the modes of experience are represented in space Y. The space Y will be significantly bigger than space X. This futuristic space of Y may have access to new types of emotions other than our conventional happy, sad and mad. This new space of Y can even allow us to comprehend abstract thoughts that reflect what we wish to express more accurately.

This new space of Y can actually unlock a new world of possibilities that lies beyond our current imagination. The people of the future will think, feel and experience the world at a much richer degree than we can today.


10 years ago, most of our communication were restricted to phones and emails. Today, we have access to video conferences, Virtual Reality and a wide array of applications on social media. As we enhance our cognitive abilities and emotional intelligence, we can express ourselves through idioms of far greater resolution and lower levels of abstractions.

We already have students from the University of Florida achieving control of drones using nothing but the mind. We even have access to vibrating gaming consoles that take advantage of our sense of touch for making that Mario Kart game that much more realistic. 10 years from now, the way we communicate with each other will be much deeper and more expressive than today. If we are hopeful enough, we might even catch a glimpse of the holograms of Star Wars and telepathic communications of X-Men.

Virtual Realities of today only limit us to our vision and sense of hearing. In the future, Virtual Realities might actually allow us to smell, taste and touch our virtual environment. Along with access to our 5 senses, our emotional reaction to certain situations might be fine-tuned and optimized with the power of AI. This might mean sharing the fear of our main characters on Paranormal Activity, feeling the heartbreak of Emma or being excited about the adventures of Pokemon. All this can be possible as we explore the theatrical arts of smart Virtual Reality consoles.

Information Security

AI allow us to unearth more unstructured data at higher velocity to generate valuable insight. However, the risk of those very sensitive data falling into the wrong hands will also escalate.

Today, cybersecurity is a major concern on everyone’s mind. In fact, 2017 is the year the fingerprint got hacked. With the help of AI, information technology will get more sophisticated in order to protect the things we value in our lives.

It is human nature to want to go beyond our limits and become something much more. Everyone wants to live longer healthy lives, experience more vividly and feel more deeply. Technology is simply a means to achieve that end.

See other FICO posts on artificial intelligence.

The post The Future of AI: Redefining How We Imagine appeared first on FICO.

          FDA Approves the First Dose-Stretching Vaccine For H5N1 Bird Flu        
To prepare for a potential pandemic of avian influenza caused by H5N1, the Food and Drug Administration approved the first vaccine boosted so its doses can provide stronger immune responses against the flu virus. Most bird flu viruses do not harm people, but the H5N1 strain may be fatal in up to half of those infected. It likely originated in poultry, and does not transmit effectively from person to person, but if the virus mutates and becomes more infectious, it could spread easily among unprotected populations. In 2007, the FDA started stockpiling the first vaccine against H5N1, to prepare for a possible pandemic. The latest vaccine will be a second vaccine option, and could be helpful if inventory of the immunizations starts to run low, since this version can provide enhanced immunity with a smaller dose. “This vaccine could be used in the event that the H5N1 avian influenza virus develops the capability to spread efficiently from human to human, resulting in the rapid spread of disease across the globe,” said Dr. Karen Midthun, the director of the FDA’s Center for Biologics Evaluation and Research in a statement. “Vaccines are critical to protecting public health by helping to counter the transmission of influenza disease during a pandemic.” The vaccine, made by GlaxoSmithKline, is not available for commercial sale or purchase. FDA reviewed studies involving 3,400 people who were vaccinated with the new shot, and compared their responses to another 1,100 who were inoculated with a placebo. [FDA]
          Source : Handbook of Strategy and Management        

Strategic Change Issues Associated with Life Cycle Dynamics

The genesis of life cycle dynamics in the strategy literature may be traced to early work in technology studies. Two counter-forces shape the development and diffusion of technological systems. One is a ‘law of progress’ (Adams, 1931) that points to an exponential growth in the development of a technological system after a relatively slower start. A second force is the ‘law of limits’ that represents the physical limits one invariably confronts with the performance of a technological system. Together, these two forces combine to prescribe an ‘S’ shaped curve in the development and diffusion of a technological system (Foster, 1986).

Life cycle dynamics implicit in the ‘S’ shaped curve were productively employed in other disciplines as well. In the marketing literature, for instance, these dynamics are manifest in product life cycle issues (Kotler, 1994; Mahajan et al, 1990). In the economics literature, life cycle dynamics are apparent in the works of economists such as Vernon (1966). In the organizational field, life cycle dynamics can be found in conceptualizations of organizations progressing from one crisis to another as it grew in scale and scope (Greiner, 1972). They are also implicit in the contagion models that have been employed in diffusion studies and the creation of bandwagons in the development of fads and fashions (Abrahamson, 1991; Rogers, 1983). Clearly this is not an inclusive but an indicative list of those who have contributed to this way of thinking. However, as is apparent from even this short survey, life cycles unfold at various levels.

Several issues confront practitioners associated with processes exhibiting life cycle dynamics. First, there is a need to determine the stage in the life cycle of the organizational entity that is undergoing change. Monitoring internal and external contexts is an approach that has been advocated for this purpose. Although monitoring might appear to be a routine task, cognitive biases may create many difficulties in accomplishing this task (Kahneman et al., 1982; Kiesler and Sproull, 1982; Dutton and Jackson, 1987). Despite these difficulties, some tell-tale signs that have been employed to determine what stage an industry might be in its development are product price, the level of commoditization, the number of new entrants and exits.

In addition to correctly recognizing the stage of development of the entity being examined, another managerial challenge is determining the appropriate mode of operation in each stage of a life cycle. For instance, Utterback (1994) suggests that strategy implies competition based on functionalities during a ‘fluid’ stage of technology development whereas it implies competition based on reliability, quality and price during a ‘specific’ stage of development. Similar considerations have led others to suggest that a firm should be organized to ‘explore’ during early growth stages and organized to ‘exploit’ during later stages (March, 1991).

The most difficult challenge in managing processes driven by life cycle dynamics is to make transitions in between stages. Transitions are difficult as they imply changing one set of competencies well suited for one stage of operation to a different set of competencies required for a different stage of operation. Indeed, appropriate forms of behavior at one stage of operation may be the very forces that prevent organizations from transiting to the next stage. In other words, transitions become difficult as competencies at one point become traps (Levitt and March, 1988; Leonard-Barton, 1992).

While life cycle models are seductively simple to understand, they are easy for managers to misread. For instance, in the development of cochlear implants (a bio-medical prosthetic device), proponents of the single-channel device that gained early FDA approvals concluded to their peril that industry dynamics had switched to a growth and maturity stage (Garud and Van de Ven, 1992). This belief turned out to be misplaced when other firms continued developing their cochlear implants under the assumption that the industry was still at an introductory stage.

In a similar vein, Henderson (1997) illustrates how beliefs about the limits of a technology based on its internal structure can be misleading. Using the development of optical photolithography as an example, Henderson shows how the ‘natural’ or ‘physical’ limits of the technology were relaxed by unanticipated progress on three fronts: significant changes in the needs and capabilities of users, advances in the performance of component technologies (lenses), and unexpected development in the performance of complementary technologies. These observations lead Henderson to caution against using a life cycle model to predict the limits of a technology. Such predictions must be tempered by a recognition that many other factors (beyond the immediate grasp of those forecasting) may play a role in extending the life of a technology.

Life cycle dynamics are at play in a key field that drives change in contemporary times -semiconductors. For about three decades, Moore's law described progress that has been made with semiconductor chips - a doubling of the number of chips that might fit into a silicon chip every 18 months. Announcements by scientists at Intel suggest that the silicon substrate may be reaching its limit (Markoff, 1999). In Grove's terminology, these limits may represent the onset of a strategic inflexion point with the potential to create a ‘10X change’ (Grove, 1996). As this limit is reached, semiconductor firms will have to decide whether to continue with silicon chips, shift to a new architecture or to a new substrate. To ensure that Intel makes appropriate decision as it encounters this and other such inflexion points, Grove and his colleagues have put in place ‘dialectical processes’ that shape decision making at Intel. We explore issues associated with dialectical processes as they pertain to strategic change in the next sub-section.

          Emergent files application to expand production of BioThrax        

Emergent BioSolutions has filed a supplemental Biologics License Application with the U.S. Food and Drug Administration to scale up production of its anthrax vaccine BioThrax.

BioThrax is the only FDA-approved anthrax vaccine for humans. It's primarily produced for and purchased by the U.S. military, and has been in distribution since the 1970s.

Emergent's most recent application concerning BioThrax said production of the vaccine would begin in its large-scale production facility known as "Building 55."

“Emergent is pleased to have reached this significant milestone in our BioThrax comparability program," Biodefense Division President and Executive Vice President Adam Havey said. "We believe that our submission conveys the robustness of our large-scale manufacturing process, the comparable product attributes, and the efficacy and consistency of the product from our new facility, supported by a variety of developmental and pivotal nonclinical studies. This milestone reflects many years of steadfast dedication from our project team and their effective collaboration with the U.S. government.”

Havey said the company expect the FDA to complete its review of Emergent's recent application by the fall.

          House oversight subcommittee reports on safety of bioresearch labs        

The House Energy and Commerce Subcommittee on Oversight and Investigations has released a report on its investigation of allegations that a bioresearch lab in Maryland mishandled vials of smallpox.

The issue was expected to be discussed Wednesday during a hearing with U.S. Food and Drug Administration (FDA) and National Institutes of Health (NIH) officials on Capitol Hill.

The subcommittee's report calls for further investigation into each agency's handling of potentially dangerous biological agents, including antibiotic-resistant anthrax and antibiotic-resistant plague. According to the memo, research facilities have failed to conduct regular inventories of hazardous materials, account for the whereabouts of vials of hazardous materials and restrict access to the hazardous materials.

“There’s a problem when the government somehow loses track of smallpox and other deadly agents, only to have them turn up in a soggy cardboard box,” Energy and Commerce Committee Chairman Fred Upton (R-MI) and Oversight and Investigations Subcommittee Chairman Tim Murphy said in a joint statement. “What’s worse, the urgency that should accompany such a discovery has failed to spur absolutely necessary changes. Today serves as an important opportunity to ask some of the agencies in question about their next steps to ensure safety for those working in the labs, as well as the general public.”

The Government Accountability Office also raised the issue in its own report.

The subcommittee is expected to call for a full internal investigation by both the FDA and NIH.

          FDA gives clearance for Great Basin E.coli test        

The U.S. Food and Drug Administration (FDA) recently gave the clearance for Great Basin Scientific Inc. to conduct its Shiga Toxin Direct Test.

The FDA gave them 510(k) clearance for the test, which is intended as a molecular test to detect E.coli that produces Shiga toxins. The test will most likely be tested on the Great Basin Analyzer, which also performs tests for Clostridium difficile and Group B Streptococcus.

The Great Basin Shiga Toxin Direct Test will allow lab techs to get immediate results from samples. It will require under one minute of hands-on contact. It will detect stx1 and stx2, while providing results quickly

“We are pleased to receive 501(k) clearance for our Shiga Toxin Direct Test, and are excited about the opportunity to drive new site placements with this unique test,” Ryan Ashton, co-founder and CEO of Great Basin Scientific, said. “By offering the only direct-from-patient specimen test, and identifying the O157 strain and quickly detecting stx1 and stx2 genes, we are providing clinicians a powerful tool to provide a better outcome for their patients. The clearance of this test is particularly timely given the growing number of multi-state outbreaks for Shiga toxin-producing Escherichia coli O157 (STEC O157) infections.”

          FDA approves new inhalational anthrax treatment        

Officials with the U.S. Food and Drug Administration (FDA) recently approved the Anthim (obiltoxaximab) injection, to be used with specific antibacterial drugs to treat people who have had inhalational anthrax.

Anthim has also been approved for preventing inhalational anthrax if other alternative therapies are unavailable or inappropriate.

Inhalational anthrax, a rare illness, happens when people are exposed to animals or animal products that are either contaminated or infected with the disease. Sometimes people are exposed to the disease when anthrax spores are intentionally released.

When anthrax spores are released, people inhale the bacterium Bacillus anthracis spores. Then the bacteria spreads through the body, generating toxins that cause irreversible and massive tissue injuries that lead to death.

Anthim, a monoclonal antibody, eliminates the toxins that anthrax generates. The FDA has approved Anthim as part of its Animal Rule, enabling researchers to conduct efficiency studies within well-controlled, adequate animal studies. Scientists hope to see Anthim progress to human studies in the near future.

In the past, anthrax has been used as a bioterrorism threat. The spores resist destruction and easily spread through the air, making them a bioweapon of choice.

“As preparedness is a cornerstone of any bioterrorism response, we are pleased to see continued efforts to develop treatments for anthrax,” Edward Cox, director of the Office of Antimicrobial Products in the FDA Center for Drug Evaluation and Research, said.

          New Device-Based Therapy Reduces Severe Asthma Attacks        
Bronchial thermoplasty (BT), is a new device-based therapy approved by the FDA in 2010 and uses a series of three radio-frequency treatments to open the

           FDA Approved a Device Meant to Treat Cluster Headaches        
The FDA has approved the first noninvasive vagus nerve stimulation device, gammaCore, for the acute treatment of pain from episodic cluster headache in

          A Female’s Guide: How to Optimize Your Sex Life        

The topic of female sexuality has progressively become more accepted in modern society, but there are many regions throughout the world where it remains heavily stigmatized. The sexual revolution of the Western world has primarily focused on female reproductive health and rights, but the topics of female sexual desire and pleasure have also steadily gained acknowledgement. Within the past decade, the feminist movement has gained strength in numbers and media exposure, leading to a surge in female sexual empowerment and increased opportunities for women to explore their sexual identity. Needless to say, there is still a great deal of work to be done in the female sexual empowerment movement. This is to be expected, as humans have primarily focused on the sexual urges and desires of men since the dawn of mankind. Mankind. The status of female sexuality and sexual health can be largely attributed to the uneven power dynamics between men and women.1 The female sexual revolution is a laborious process with challenging, long-term goals. However, there are numerous measures that you can take to increase your personal and sexual satisfaction. By living a happy and sexually fulfilling lifestyle, you can in turn educate your peers about the importance of awareness, knowledge and resources available in your community. This guide serves as a tool to help navigate females through the intricate and overlooked topics regarding their sexuality. Individuals like yourself can take part in the female sexual revolution by becoming educated and comfortable with your body, portraying your confidence and insight to the people that surround you and living a happy and healthy physical, mental and sexual lifestyle.


Step 1: Education

Education is the first step to improving the sexual health and rights of females because without an accurate understanding of their needs and desires, there cannot be progress. Educating yourself on the various methods and health practices that promote mental and physical health will not only help you to feel happier and more confident on a daily basis, but this positivity will also carry over into your sexual lifestyle. Female sexual health is often only discussed when it relates to sexual disease, dysfunction and child-rearing basis. Although these are highly important topics, this approach fails to consider a female’s romantic needs, sexual pleasure and mental health.  Ask your doctor about what resources are available for women in your community and engage in discussion with your peers. Asking questions about your sexual health and seeking help for any problems you may experience will allow you to gain knowledge, confidence, and an understanding of your body. This can also open the door for conversations with your doctor, family, friends and partners in the future.

Once you have educated yourself on how to improve your physical, mental, and sexual health, the next step is to make this process more personal to you. If you feel unfamiliar or uncomfortable with your anatomy, take a few minutes out of each day to explore your body. Become familiar with every part of your body and how it feels to touch different areas. Be curious! Don’t hesitate to use a small hand mirror to look at yourself. Or just close your eyes and explore the various erogenous zones of your body with your hands. This can help you to relax and become familiar with what areas are most sensitive and enjoyable to touch.

For women who experience negative body image, the education and self-exploration steps may be difficult. The media portrays the female (and male) body in extremely unrealistic ways, which can create impossible standards to live up to. If it is difficult for you to find pride in the way that  you look, try to find self-confidence through what you do and who you are. Whether you are great at your job, a fantastic mother, a reliable friend, or an attentive partner, recognize the aspects of your life where you succeed and give yourself some credit! It does not matter how much you weigh, how flat your stomach is or what size clothes you wear. The more you like yourself, the more others will want to be around you and enjoy your company. The more comfortable you feel in your own skin, the more you can relax and enjoy sex, whether it’s during masturbation or with your partner. You do not have to fit society’s standards to be and feel physically beautiful. Feeling good, beautiful and confident inside and outside is important. Everyone is beautiful. Make an effort to find the parts of your body that you love.

Step 2: Adopt a Healthy and Happy Lifestyle

An active lifestyle can contribute to a healthy weight, a reduced risk for cardiovascular disease, and improved mental health and mood. It can also lead to more pleasurable sexual experiences.2 Exercise increases blood flow to the sex organs, in addition to boosting mood through the release of exercise-induced chemicals called endorphins, also known as the “feel-good chemicals.”3 Additionally, testosterone levels are heightened during the hour following exercise, which can lead to an increased sex drive.3 Daily exercise is incredibly important, but establishing a realistic and sustainable routine is even more crucial. Setting goals for yourself and working alongside your partner can be excellent motivators for sustaining your healthy diet and lifestyle. A healthy and balanced lifestyle can lead to increased fitness and confidence, in addition to helping you feel more sexy, playful and open to trying new things inside and outside of the bedroom with your partner.

Sex Enriching Foods: There are many foods that can increase libido by increasing blood circulation to the sexual organs:

  • Garlic, chili peppers, and ginger contain allicin, which dilates blood vessels and thins the blood.3
  • Omega-3 fatty acids found in fish also help to thin the blood and increase elasticity of the blood vessels, allowing for easier blood flow.3
  • Dark chocolate contains antioxidants in addition to phenylethylamine, which has a stimulating effect by releasing the neurotransmitter dopamine and serotonin in the brain.3 Dopamine is associated with feelings of pleasure and love, while serotonin helps regulate mood and memory.4


Stress has a profound effect on the functioning of the human body. When the body is under high levels of stress, this leads to a release of the hormone cortisol, which is known to suppress the sexual response cycle and cause low libido.3 Maintaining low levels of stress is important for cardiovascular, mental, and sexual health. Finding a balance between work, family, hobbies, your partner and your personal time can be difficult, but it is a key element for a healthy lifestyle.


Step 3: Communication

Maintaining strong, open communication is crucial in sustaining a gratifying personal relationship and sexual experience with your partner. Making assumptions about what your partner is thinking or feeling based on their body language alone is not a reliable way of communicating. Discussing any concerns or problems that you may have before engaging in sex is the best way to avoid unwanted situations and discomfort so your experience is not filled with worry or apprehension. Keeping the dialogue open throughout sex can also ensure that you have your partner’s consent and that you are both enjoying the experience. Sexy talk is a form of communication in which individuals discuss intimate scenarios together and this can be a great way to maintain communication during sex. Engaging in sexy talk before, during, or after sexual intercourse can heighten the excitement and connection between you and your partner by keeping you both in the moment, and allowing you to introduce specific sexual positions or scenarios that you would like to try. Sexy talk can also help reaffirm that you are both enjoying yourselves and make you both feel confident and empowered. 

If you feel uncomfortable discussing your sexual desires with your partner or find that it is difficult to bring up the subject in a conversation, try writing a letter or email to your partner. Writing down your thoughts, desires, or concerns is a great way to express yourself because you can take time to formulate your ideas and ensure that you address the subject in its entirety.

If you have suffered trauma in your past, this can put a strain on a relationship if you have refrained from sharing it with your partner, your partner has problems coping with it, or if your partner does not know how to provide you with all the support that you need. Although it may be a difficult subject to discuss, confiding in your partner can bring you closer together and provide you with an additional personal resource to help you navigate through the healing process. If your partner feels uncomfortable or unable to advise you on the trauma on their own, group or couple’s counseling is an excellent option to help move the dialogue forward in a useful way. Seeking help for any personal or relationship problems can allow you to let go of previous trauma, establish stronger relationships with individuals that you can confide in the future, and allow you to move forward with your life and pursue the things that make you the most happy.

Step 4: Address Any Sexual Difficulties  

It can be difficult to talk about sexual difficulties with your partner or your doctor, but sexual dysfunction is common (43 percent of women and 31 percent of men report some degree of difficulty during their lifetime).5 These problems can occur at any stage of a male of female’s life and it is not something that you need to be ashamed of. There are many resources on SexInfo to help navigate you through this process and educate you on the possible causes and treatments.

Vaginal Dryness

Insufficient lubrication can be caused by a number of factors including inadequate amounts of foreplay, poor body image or self-confidence issues, improper diet or exercise, menopause, anxiety and stress, lack of partner communication, or prescription medications.6 In addition, some female bodies just do not produce enough lubrication for a pleasurable sexual experience, even if they do not possess any underlying medical issues and they are sufficiently aroused.

A female’s body experiences a multitude of changes throughout the lifecycle. Vaginal dryness is typical during menopause due to changes in estrogen levels. This reduction in vaginal lubrication can lead to painful intercourse and a decreased libido. Fortunately, there are multiple over the counter remedies available for women experiencing vaginal dryness. Vitamins B, A and beta carotene are high in essential fatty acids and may be taken as supplements to increase vaginal lubrication.7 Vitamins E and A suppositories can also be inserted in the vagina to provide relief for vaginal dryness.7 Drinking plenty of water, decreasing alcohol and caffeine intake, and refraining from douching or harsh chemical soaps that interfere with the vaginal pH levels can all lead to an increase in vaginal lubrication.6Personal lubricants (also known as “lube”) can also be utilized during sexual intercourse to help reduce friction and irritation, thereby increasing sexual pleasure.

Estrogen is an important hormone that is responsible for keeping a female’s vaginal tissues healthy. This hormone helps to maintain the vagina’s normal lubrication, acidity levels, and elasticity.7 When estrogen levels decline, the lining of the vagina becomes thinner and less elastic, leading to a decreased production of vaginal lubrication. Estrogen levels drop during and after menopause, during pregnancy, and during periods of breastfeeding.7 Estrogen can also decrease in females who smoke cigarettes, who have had their ovaries removed, who have been previously treated for cancer, or who have certain immune disorders. Estrogen cream can help relieve vaginal dryness, but they are also notorious for causing a variety of other unpleasant symptoms.7 Talk to your doctor if you are experiencing vaginal dryness and discuss the best options pertaining to your medical history.


Low Libido

Low sexual desire can have large variety of causes including age, menopause, negative sexual experiences, depression, anxiety and stress, habituation to one’s partner, or relationship problems to name a few.7 Researchers are avidly searching for the “female Viagra,” but many drugs are still in the testing phase and include adverse side effects. If you are experiencing a lack of sexual desire, talk to your doctor about what might be causing this and whether there are any supplements or prescriptions that could benefit you:

  • ArginMax is a multivitamin with added ginseng, gingko and L-arginine, that has been clinically studied and shown to positively affect sexual satisfaction, orgasm ease and sexual desire in study subjects.8 The package suggests that it should be taken daily for four to eight weeks before results are noticed. As with any over-the-counter dietary supplement, it is important to check with a primary-care doctor to be sure that none of the ingredients are unsafe for an individual’s health and medication profile.
  • Intrinsia is currently under review by the Food and Drug Administration (FDA) as a testosterone therapy for women with low sexual desire.9 This drug has not been approved by the FDA yet because the effects of testosterone on women are not fully understood, but the hormone has been linked to issues such as liver damage and the development of male secondary sex characteristics (more body hair, deep voice, etc.).10
  •  Addyi is a non-hormonal prescription pill used to treat Hypoactive (low) Sexual Desire Disorder (HSDD) in women who have not gone through menopause and have not had problems with low sexual desire in the past.10 Addyi can cause severely low blood pressure, fainting, and sleepiness, so be sure to discuss the various side effects and risks associated with each alternative with your doctor.

Supplements and prescription drugs should be used as a last resort, if lifestyle changes are not leading to any noticeable changes in your sex life. Sexual desire is dependent not only on socio-cultural, psychological, and interpersonal influences, but also on each person’s biology. Because so many factors are involved, it can be difficult to pinpoint the source of the problem. Prescription drugs can also lead to adverse side effects that could possibly interfere with your sexual lifestyle more than it benefits it.


Step 5: Novelty

Partaking in a fun, new and exciting activity can lead to an increase in the brain chemical dopamine, which helps fuel sex drive.3 Adding some novelty to your sex life can increase pleasure and add excitement to the scenario:

  • Reflect and share your desires – Give yourself some time to reflect on your sexual desires and turn-ons. What is most exciting to you? What are you open to trying? Allow yourself to think about what you, and only you desire. Once you have an idea of what you might be interested in, share this with your partner in whatever way feels most comfortable to you. Whether this is writing them a note, or beginning a discussion together as a form of foreplay, share some of your new revelations with your partner and ask them about their fantasies. Do not feel obligated to engage in the entirety of the fantasy if you become uncomfortable at any point. Maintain an open dialogue with your partner, particularly during the experimental phases.
  • Try a new sex position – Do not be afraid to be adventurous! As long as you keep communicating and ensure that you and your partner are comfortable, sex positions can be a great way to add novelty to a relationship. See Sexpert Approved Sex Positions, Sexual Positions for Overweight Individuals and Sexual Positions for Pregnant Couples.
  • Buy a new sex toy or prop – A sex toy can add a lot of excitement to a sexual scenario by adding additional stimulation and novelty to a familiar sex position. You can use the sex toy on each other, through manual stimulation of yourself in front of your partner, or during your private masturbation time. A prop such as a blindfold can heighten the sense of touch by eliminating visual distractions. Picking a new toy or prop out together can ensure that you and your partner get something you both will enjoy. 

  • Boost your confidence and add some spice – Treat yourself to some sexy lingerie or a new outfit for your next encounter. Feeling beautiful correlates to feeling confident and confidence allows for an enjoyable sexual experience.
  • Your novelty does not have to be sexual – You and your partner do not have to directly make changes to your sex life to influence it. Trying something new like a couples yoga class, dance lessons, or an adventurous hike all lead to increases in excitement (dopamine), while simultaneously allowing you and your partner to spend quality time together and nurture your relationship.

Adding some novelty to your sex life can help rejuvenate a connection between you and your partner.  Check out the Spice Up Your Sex Life section on our website to learn more about Sexpert approved techniques.


Step 6: Masturbation

Masturbation can help you learn more about your body and determine what pleasures you the most. Masturbation is all about you. This practice can allow you to experiment with touch and determine what speed, pressure, intensity, or technique makes you feel the best. Many women enjoy incorporating a vibrator or dildo into their masturbation technique, because it can target the sensitive clitoris or g-spot. Check out the female masturbation article to learn more about different methods. 


Step 7: Intentions

When life becomes stressful, it can be difficult to find time for sex and intimacy, or even just a moment for oneself. Taking a moment to set an intention for the day or set an intention before engaging in intercourse with your partner can help to bring you back into the moment and gain more pleasure from the experience.  Whether your intention is to not think about work, to spend the evening with your partner without distractions, to be more mindful of your relationship with your partner, or to tell yourself that you are beautiful and you are doing the very best you can do, try to let go of unnecessary worries and live in the moment. A few moments of relaxation, deep breathing, meditation, or self-reflection each day can help you find some peace and clarity even on the busiest of days. Setting an intention before sex and resolving any conflicts with your partner beforehand can allow you to focus more on the experience and heighten the pleasurable sensations even further.

Female sexuality is incredibly complex and there is a lot that scientists still do not understand. Being confident in yourself and your sexuality as a female is an excellent way to not only live a happy and fulfilling life, but also to open up the conversation about the female population’s specific needs and rights as a whole.



  1. Bass, T. M. "Exploring Female Sexuality: Embracing the Whole Narrative." North Carolina Medical Journal 77.6 (2016): 430-32. Web. 28 Jan. 2017.
  2. "Physical Activity and Health." Centers for Disease Control and Prevention. Centers for Disease Control and Prevention, 04 June 2015. Web. 28 Jan. 2017.
  3. Kotz, Deborah. "5 Natural Ways to Boost Sex Drive." U.S. News and World Report: Health. N.p., 6 Nov. 2008. Web. 28 Jan. 2017.
  4. "Depression: Dopamine vs. Serotonin: Which Is More Important?" Mental Health Daily. N.p., 11 Jan. 2017. Web. 28 Jan. 2017.
  5. "Sexual Dysfunction & Sexual Disorders." Cleveland Clinic. N.p., n.d. Web. 10 Feb. 2017.
  6. LeVay, Simon, Janice I. Baldwin, and John D. Baldwin. Discovering Human Sexuality. Sunderland, MA: Sinauer Associates, 2009. Print.
  7. "5 Ways To Naturally Increase Vaginal Lubrication." Lady Care Health. N.p., 10 Nov. 2014. Web. 28 Jan. 2017.
  8. "ArginMax For Women." Sexual Enhancement For Women | ArginMax For Women. N.p., n.d. Web. 28 Jan. 2017.
  9. Streicher, Lauren. "Viagra for Women: Long Time Coming - Midlife, Menopause and Beyond." Midlife Menopause and Beyond. N.p., 22 Jan. 2014. Web. 28 Jan. 2017.
  10. "The Effects of Women Taking Testosterone." LIVESTRONG.COM. Leaf Group, 22 June 2015. Web. 28 Jan. 2017.
  11. "Addyi (flibanserin, 100mg Tablets)." Addyi (flibanserin, 100mg Tablets). N.p., n.d. Web. 28 Jan. 2017.


Last Updated: 11 February 2017. 

          Re: Off topic topic        
wizardofcars wrote:

New off topic note the FDA just announced that cloned meat is safe to eat.

Yes a special label will be on the cloned meat.

Oh yeah that's just great next thing you know they're gonna announce a Grand Army of the U.S. which will be cloned from uh........hey that's a good question if the U.S. made a clone Army who would they clone it from? Be reasonable don't say something retarded like "Me" or "michael Jackson" ok well anyways I nominate the following people:

1. Arnold Scwarzennegar ( how da F&*K do u spell his last name??), because he used to be really strong, so maybe that would help his clones.

2. uh.............that's all I can think of for now but there's a few other people that could be the template, I assure you.

draco fett wrote:

Thank you, that sounds good. At the moment we are calling him OB; Other Bunny. He really seems to like it here. He used to be a therepy rabbit.

What's a "therapy bunny"?

          Re: Off topic topic        

New off topic note the FDA just announced that cloned meat is safe to eat.

Yes a special label will be on the cloned meat.

          LexaMed Presenting at BioOhio FDA Regulatory 101 Series: Medical Device Testing, Emerging Trends and Regulatory Expectations        
August 18, 2016/in Events /by computol Come and join us at the BioOhio Meeting on Wednesday, September 28, 2016. LexaMed President, Bob Reich will be speaking Join us to learn more about FDA requirements for reprocessing reusable medical devices (cleaning/disinfection/sterilization), AET, Environmental Isolates and Quality Management. For more information, click here   Where: Ascend Innovations […]
          FDA Continuing to Issue 483’s to Compounding Pharmacies        
FDA continues to issue 483s to compounding pharmacies for a lack evidence and cGMP framework in preventing/mitigating beta-lactam cross-contamination Warning Letters and significant FDA 483 observations continue to plague the compounding pharmacy industry with over 40% of compounders inspected receiving Warning Letters and nearly 100% receiving critical observations. One of the more common observations cited […]
          Unsupervised Learning: No. 82        

This week’s topics: Live from London, Gamestop hacked, PowerPoint malware, Chinese Apple Hack, XSS, WWDC summary, FDA approves cancer drug, heroin $51B, ideas, discovery, recommendation, aphorism, and more… This is Episode No. 82 of Unsupervised Learning—a weekly show where I curate 3-5 hours of reading in infosec, technology, and humans into a 15 to 30 minute summary. The...


I do a weekly show called Unsupervised Learning, where I curate the most interesting stories in infosec, technology, and humans, and talk about why they matter. You can subscribe here.

          Drug Safety Associate - Merck - West Point, PA        
A Bachelor's degree, preferably in a biological science, nursing, or pharmacy. West Point, PA. FDA regulations, the prompt or periodic classification of each... $80,000 a year
From Indeed - Tue, 01 Aug 2017 11:14:53 GMT - View all West Point, PA jobs
          VGI Medical Announces FDA Clearance of the VerteLP® Lateral Lumbar Cage System        

First lateral lumbar cage with integrated plating featuring bi-cortical fixation

(PRWeb January 19, 2016)

Read the full story at http://www.prweb.com/releases/2016/01/prweb13170416.htm

          Why Did The FDA Approve 57 Percent Fewer New Medicines Last Year Than 2015?        
The Food and Drug Administration has reported it approved only 19 innovative new medicines last year, versus 51 in 2015. To be sure, 2015 was a high-water mark. Nevertheless, such a dramatic drop signals a problem for patients eager for new treatments. These new drugs, though few, represent advances in the treatment of ovarian cancer, […]
          Capitol Hill Update: July 17, 2017        


The House and Senate are in session this week.

There are nine (9) legislative days remaining for the House before the August recess and 57 legislative days remaining in the year. The Senate will work through the first two weeks of the August recess.


After the passage of the nearly $700 billion National Defense Authorization Act on Friday, it'll be a relatively slower week in the House, at least on the floor of the chamber. Committees and subcommittees will be very active this week.

Today, the House will take up three pieces of legislation on the suspension calendar, two of which relate to mass transit the District of Columbia, Maryland, and Virginia. One resolution, H.J. Res. 92, allows the D.C., Maryland, and Virginia to amend Washington Area Transit Regulation Compact, which regulates transit D.C. and its suburbs. The other resolution, H.J.Res. 76, allows D.C., Maryland, and Virginia to create the Washington Metrorail Safety Commission. After all, what Metro needs is another layer of bureaucracy. (Yes, that was sarcasm.)

Three more bills will be considered on the suspension calendar on Tuesday. The Ozone Standards Implementation Act, H.R. 806, sponsored by Rep. Pete Olson (R-Texas), will also be considered, though likely under a rule to limit or prevent amendments, much like virtually every other bill the House has brought the floor under "regular order" this year.

On Wednesday, the House will take up the Promoting Interagency Coordination for Review of Natural Gas Pipelines Act, H.R. 2910, introduced by Rep. Bill Flores (R-Texas), and the Promoting Cross-Border Energy Infrastructure Act, H.R. 2883, introduced by Rep. Markwayne Mullin (R-Okla.). Both bills will likely be brought to the floor under a rule.

Finally, on Thursday, the only bill currently scheduled to hit the floor is the King Cove Road Land Exchange Act, H.R. 218, sponsored by Rep. Don Young (R-Alaska). The bill will likely to come to the floor under a rule.

Though it's not currently on the calendar, the 21st Century Aviation Innovation, Reform, and Reauthorization (AIRR) Act, H.R. 2997, introduced by Transportation and Infrastructure Committee Chairman Bill Shuster (R-Pa.) could come to the floor for a vote this week. The bill reauthorizes the Federal Aviation Administration (FAA) and reforms the United States' out of date air traffic control (ATC) system. FreedomWorks has released a key vote in support of the 21st AIRR Act.

Outside normal legislative business, there is increasing chatter about the FY 2018 budget. The House Majority Whip's office hosted a briefing on the budget on Friday. As of now, it's unclear what to expect from the budget.

The House Appropriations Committee will complete its work on the 12 appropriations bills this week. The Whip team will be talking to House Republicans today about lumping all 12 appropriations bill into yet another omnibus. Of course, this is because the last one went over so well with conservatives. (Yes, that's more sarcasm.)

The committee schedule for the week can be found here.


The Senate was supposed to bring the Better Care Reconciliation Act (BCRA), H.R. 1628, to the floor this week for a procedural vote. Leader Mitch McConnell (R-Ky.) has delayed legislative action because Sen. John McCain (R-Ariz.) is set to have eye surgery, giving Leader McConnell one less vote that he will almost certainly need to advance the bill. Additionally, the Congressional Budget Office's score of the bill has been delayed by at least a day. The score was supposed to come out today.

The latest iteration of the BCRA was rolled out on Thursday. FreedomWorks explained some of the major changes to the bill. Our friends at the Texas Public Policy Foundation have a solid overview of the latest version compared to previous versions. Though there are questions that need to be answered, the bill appears to be a slight improvement over existing law.

The biggest question that needs to be answered is whether the Consumer Freedom Option will work in single risk pools, as mandated by the BCRA. The Consumer Freedom Option, which was included thanks to the efforts of Sens. Ted Cruz (R-Texas) and Mike Lee (R-Utah), would work best with bifurcated risk pools, where health insurance companies could price a traditional risk pool differently, with lower premiums, than the ObamaCare exchanges, which would effectively function as a high-risk pool, with access to more than $180 billion in subsidies.

It's unclear whether there are enough Republican votes to get past the initial motion to proceed. Sens. Susan Collins (R-Maine) and Rand Paul (R-Ky.) have gone on record as no votes. Sen. Dean Heller (R-Nev.) is facing pressure back home, as Republican Gov. Brian Sandoval opposes the bill. Similarly, Republican Gov. John Kasich, who also opposes the bill, could influence Sen. Rob Portman (R-Ohio) to vote against it.

FreedomWorks believes the bill may be a mild improvement over existing law, but there are serious concerns over how the Consumer Freedom Option will work, or if insurers will even bother to offer such plans because of the single risk pool mandate. The mindset right now is protecting what gains conservatives have made. Once the Senate gets past the motion to proceed, if it does, FreedomWorks expects to key vote against amendments that will undermine the Medicaid modernization, HSA reforms, and other positive reforms.

If a 2015-style repeal amendment is offered by a conservative senator, FreedomWorks will key vote in support of it, triple-weighted.

In addition to a backlog of nominations, the Senate still has several pieces of legislation awaiting floor action, including Coast Guard Authorization Act, S. 1129; the FDA Reauthorization Act, S. 934; the National Defense Reauthorization Act. The debt ceiling is rumored to be a top item either before the August recess or while the Senate works through the first two weeks of the recess.

In committees this week, the Commerce, Science, and Transportation Committee will hold a hearing on the reappointment of Federal Communications Commission (FCC) Chairman Ajit Pai on Wednesday. Chairman Pai unveiled the FCC's plans to roll back Title II regulation of the Internet at a FreedomWorks' event in April. The reappointment of FCC Commissioner Jessica Rosenworcel, a Democrat, and nomination Brendan Carr, a Republican, to serve on the commission.

The Judiciary Committee will also take up the nomination of Christopher Wray to serve as the next director of the Federal Bureau of Investigation (FBI). The hearing is scheduled for Thursday.

The full committee schedule for the week can be found here.

          Herbal Supplements - A New Study        

In a recent commentary I argued that we should be skeptical about alternative medicine because, contrary to conventional medicine, its claims are not confirmed by science and it is unregulated by the FDA (Food and Drug Admistration). New evidence has now surfaced about herbal supplements, a staple in alternative medicine, which underscores the need for such skepticism. The evidence appears in an important research study in Canada which was published last month in the journal BMC Medicine (1) and reported this month in The New York Times (2).

The study was led by Steven G. Newmaster of the Biodiversity Institute of Ontario at the University of Guelph. He and his colleagues genetically tested forty-four bottles of popular herbal supplements sold by twelve companies in Canada and the United States. Here is what they found:

  • The products of only two of the twelve companies contained the ingredients listed on the label while the products of the other ten companies contained substitutions or adulteration with fillers, such as rice, soybean, or wheat, which were not listed on the label. In fact, the products of two of these ten companies contained none of the ingredients listed on the label. (3)
  • Bottles of Echinacea, a supplement used by millions to prevent or treat colds, were found to include a bitter weed and a plant which has been linked to rashes, nausea, and flatulence. (4)
  • Two bottles sold as St. John’s wort, a supplement widely used to treat depression, were found to include none of this herb.  One bottle contained rice and the other an Egyptian shrub called Alexandrian senna which is a powerful laxative. (5) 
  • Bottles of gingko biloba, a supplement marketed as a memory enhancer, were found to include fillers and black walnut, a hazard to people who are allergic to nuts. (6)
  • A bottle sold as black cohosh, a supplement used to treat hot flashes and other problems associated with menopause, turned out to be a bottle of a plant – Actaea asiatica - that can be toxic to humans; and (7)
  • One-third of the supplements tested showed "outright substitution," that is, there was "no trace of the plant advertised on the bottle." (8)

And what was the reaction to the study? On the one hand, a senior nutritionist at the Center for Science in the Public Interest - David Schardt - concluded that the study shows such a serious lack of quality control that people who recommend herbal supplements should stop doing so. On the other hand, spokespersons for the supplement industry - Stefan Gafner of the American Botanical Council and Duffy McKay of the Council for Responsible Nutrition - insisted that the study exaggerated the problem and that the herbal supplement industry can improve quality control without government interference. (9)

Meanwhile, in the wake of the study, three things seem clear:

  • Firstly, herbal supplements may be both ineffective and dangerous,
  • Secondly, there are very few safeguards in place to protect supplement users, and
  • Thirdly, given the political clout of the National Health Federation and other organizations which promote the interests of alternative medicine, change is unlikely. 

So, to buyers of herbal supplements, I invoke a Latin warning from the 1500s: Caveat emptor! - "Let the buyer beware!"

  1. Steven G. Newmaster et al., "DNA Barcoding Detects Contamination and Substitution in North American Herbal Supplements," BMC Medicine, October 2013, 11:22.
  2. Anahad O’Connor, "Pills That Aren’t What They Seem," The New York Times, November 5, 2013, p. D1, p. D5.  
  3. Ibid., p. D5.
  4. Ibid., p. D1.
  5. Ibid., p. D1.
  6. Ibid., p. D1, p. D5.
  7. Ibid., p. D5.
  8. Ibid., p. D5.
  9. Ibid., p. D5.

          USDA Warning: Gluten-Free Diets Cause Cancer        
WASHINGTON, D.C. –  A joint statement released today from the USDA and the FDA discusses new information, based on several years of research, that proves that a gluten-free diet, done solely on a pretentious, bandwagon-style mentality, will give you cancer. Researchers and medical staff at the Wyatt Institute in Clearwater, Michigan say that they have been...


Merupakan kombinasi dari 3 macam ramuan herbal (Red Clover, Herbalene   dan  Chapparal ) dari 3 benua (eropa, amerika & asia) yang berfungsi memurnikan darah dan memberikan nutrisi sehingga kekebalan tubuh meningkat. ramuan ini ditemukan dan digunakan oleh sir Jason Winter ketika putus asa dalam usahanya menghadapi vonis kematian 90 hari dari penyakit kankerstadium akhir. 3 minggu setelah mengkonsumsi ramuan, di luar dugaan hasilnya sungguh menakjubkan: beliau berhasil mengalahkan dan membunuh kanker yang dideritanya! dan dalam waktu 9 mingguSir Jason sudah dapat bekerja secara normal (baca buku membunuh kanker/Killing Cancer-gramedia).

1. Red Clover berasal dari benua Eropa adalah tumbuhan padang rumput yg memiliki bunga berwarna merah muda, dan populer sebelum masehi digunakan untuk memurnikan darah. Tahun 1884 mulai digunakan sebagai terapi untuk penyakit kanker payudara dan pasiennya sembuh (New York Tribune) di dapati Sir Jason Winters dari referensi buku karangan Jethro Kloss yaitu “Gospel of Essence” tanaman ini bermanfaat untuk:
·         -Memurnikan darah,sebagai antibiotic dan antiseptik
·         -Meningkatkan kekebalan tubuh
·         -Membantu mengatasi masalah ginjal,liver dan saluran pernafasan atas
·         -Menanggulangi keadaan yg tidak menyenangkan akibat rendahnya kadar estrogen

2. Chaparralberasal dari benua Amerika, sejenis tanaman kaktus, satu-satunya tumbuhan yang mampu bertahan di tempat percobaan Nuklir Ground Zero dan daerah kelembaban tinggi (Death Valley). Tahun 1968-1969 diselidiki oleh FDA di Universitas Utah Medical Centre memiliki senyawa aktif SOD (Super Oxide Dismutase) yaitu Nordihydroguaiaretic Acid (NDGA) yg berfungsi sebagai antioksidant dan menjadikan Chaparral sebagai Tumbuhan Terkuat didunia (Sa Semana Medica 2:123,1955)Dr Smart & Hogle dari Universitas Utah Medical Centre menulis artikel kesehatan yang menampilkan Ernest Farr, usia 86 th yang sembuh dari penyakit Kanker dengan Chaparral.
Manfaat chaparral :
·         -Penghancur radikal bebas
·         -Menghambat pertumbuhan tumor dan kanker
·         -Berfungsi sebagai analgesic dan antiseptic
·         -Membantu menurunkan tekanan darah
·         -Memerangi efek dari radiasi  dan pembakaran akibat sinar matahari
·         -Baik untuk masalah-masalah kulit

3. Herbalenedari benua Asia adalah tumbuhan yang banyak terdapat di China, Tibet dan India sering dipakai dalam pengobatan Chinese medication (Fu Zheng) atau sering disebut tanaman Huang Qi & 2500 tahun yang lalu Sang Budha merekomendasikan untuk untuk penyembuhan Tumor, saat ini dikembangkan dalam pengobatan penyakit kanker dan stimulus mental. dalam pengobatan modern Fu Zheng diyakini dapat memulihkan kembali kekebalan tubuh yang hilang akibat dari terapi penyinaran (radiation) dan chemotherapy.

          Breast Implant Revision - The Difference Between Silicone and Normal Saline Breast Implants        

Breast Implant Revision - The Difference Between Silicone and Normal Saline Breast Implants

Breast augmentation revision surgery san francisco
Dr. Miguel Delgado
Breast Revision Specialist

No "perfect" breast implant exits.  All breast implants have their advantages and disadvantages. There are essentially two breast implants used today: saline-filled breast implants and silicone-filled breast implants. Both breast implants have an outer pliable envelope, or shell, which is made of silicone. The contents of the shell are either saline (saltwater) or silicone gel. For saline breast implants, the silicone shell is filled with saline at the time of surgery. Saline breast implants have been used for decades: they are safe and effective.  The silicone breast implants come pre-filled.  Both come in similar sizes and shapes.

The advantages of saline breast implants are:

  • If a leak does occur, the saline (saltwater) is safely absorbed
  • Saline breast implants are filled after insertion, therefore, more adjustments can be made for volume discrepancies
  • In general, slightly smaller incisions can be used
  • Saline breast implants are less expensive

The disadvantages of saline breast implants:

  • Slightly firmer than silicone breast implants when fully inflated
  • Mild rippling or scalloping (of the bottom edge of the implant)
  • In general, not ideal for over the muscle in small breasts, thin women, due to more potential obvious rippling
Silicone breast implants have been approved for general usage since November of 2006. The restriction is that a woman must be at least 22 years of age. In addition, it is suggested by the FDA (Federal Drug Administration), though not required, that an MRI (Magnetic Resonance Imaging) be done at the three year mark after augmentation and every two years thereafter, to rule out potential silent leakage.

Silicone breast implants have evolved into a safer product as a result of two major improvements. Today’s silicone breast implants have a much thicker outer shell and they contain a much more cohesive gel than earlier versions. The latter means that the silicone contents are more solid or viscous, as opposed to the more liquid versions of their predecessors. For example, if a modern silicone breast implant is cut with a pair of scissors and squeezed, the silicone material will go out and then retract back inward into the silicone shell.

The advantages of silicone breast implants are:

  • A softer, more natural feel (the greatest advantage)
  • No wrinkles or “scalloping” of the edges; therefore, they can easily be used on top of the muscle.

The disadvantages of silicone breast implants are:

  • A leak or rupture may occur unknowingly
  • Silicone implants are prefilled and, therefore, the size cannot be adjusted
  • An MRI may be required in the future
  • They are more expensive than saline implants
Both breast implants are time tested and are great.  Each women has to weigh the benefit of each.

Dr Miguel Delgado is a breast revision specialist.  He has performed hundreds of these surgeries and has a dedicated breast implant revision website.  Also view the many before and after photos of Dr. Delgado's patients and the breast revision videos.
Dr. Miguel Delgado has offices located in San Francisco Bay Area and Marin County-Novato.  Also serving Sonoma and Napa County since 1988.
Call today 415898-4161 or email for a consultation.

          PIP Breast Implant Scare        

PIP Breast Implant Scar

San Francisco, California

There have been a lot of reports in the news lately about a French manufacturer of defective breast implants used for breast augmentation surgery. It was discovered that Poly Implant Prothese (PIP) a now defunct company had been using industrial grade silicone instead of the more expensive medical grade for their silicone implants.

In 1996, PIP was selling their saline implants in the United States including the San Francisco Bay Area, but saline and silicone implants were distributed to many countries worldwide. All silicone implants were banned in the United States from 1992-2006 due to health concerns but reintroduced after extensive testing proved them to be safe. Only two breast implant companies are approved by the FDA, Mentor and Allergan.
PIP became the third largest breast implant company in the world before being shut down in 2010 when the discovery was made. A Dutch company rebranded the implants with the name Rofil M-implants, and is also at risk as the contents are the same. In 2000 the FDA sent an inspector to the PIP manufacturing company and found many substandard practices thereby banning all PIP implants for the United States.
The American Society for Aesthetic Plastic Surgery (ASAPS) recommends women have the implants removed due to the high rupture rate and also due to the fact that the adverse effects of the impurities used in industrial grade silicone are unknown. The International Society of Aesthetic Plastic Surgery (ISAPS) supports this recommendation. Different countries have different recommendations. Several countries recommending removal besides the United States are; France, Germany, Venezuela and the Czech Republic. Some countries are setting up registries and hotlines but not recommending removal at this time.

Dr. Delgado is a breast implant revision expert.  He has performed hundreds of breast implant revision surgeries. If you are having issues you your breast implants call Today 415-898-4161 or email.   Visit Dr. Delgado breast implant revision specialized website for many before and after photos or visit his main website for other cosmetic surgery procedures.  Serving the San Francisco Bay Area, Marin County, Sonoma County and Napa Valley since 1988.

          With Latest Announcement, FDA Inches Closer to Tobacco Harm Reduction        
On Friday, July 28 the Food and Drug Administration (FDA) announced changes in their regulation of tobacco products, including electronic nicotine delivery systems (ENDS). FDA ascribed their Center for Tobacco…
          Building My Work Shop #21: Cryo or PM Turning Tools???        

Fellow turners,

I am shopping for a 1/4” bowl gouge and am trying to choose between a “cryogenic” or a “Powdered Metallurgy” gouge. They are in the same price range and both say they last “up to 3 times longer than HSS”. Do any of you have any experience using the two of them? Is one really any better than the other?

Oh & I am sure there is some sort of crazy controversial issue surrounding these materials and can’t wait to read about it. So please feel free to Rant away about how cryogenic is really alien material or PM is a FDA conspiracy. I love that kind of stuff!!!

          In The Beginning #7: Food Safe Finishes        

The Below is informational only. It in no way any reflection on anyones political beliefs. It is for those that would like to do their own research into the subject. This is NOT a political forum so please refrain from posting your political beliefs regarding the FDA or any portion of any Government Entity. We each have our own religious and political beliefs and this topic is not the place for them to be expressed. I fully respect everyones right to have their own thoughts, beliefs and ideas. However, they are not welcome here. Please feel free to start your own thread and discuss your political or religious thoughts and beliefs to your hearts content.

Anyone who posts any responses that could be construde as a politically based opinion will be blocked. There are quite literally thousands of websites devoted to politics, government, etc. This is however, a forum on Woodworking, please keep your replies on the topic of woodworking.

I recently I came across a great little pamphlet of finishing “Bob Flexner’s Finishing Facts”. I must say as a very novice finisher it did quite a bit to educate and clarify. Best of all it removed quite a bit of myth’s and replaced them with facts.

For me the most informative is the section on Food Safe Finishes. In that Section he cites Title 21, Part 175 of the Code of Federal Regulations, so you can check it out for yourself!!!!

In the article Mr Flexner states the following

“In fact, all ingredients used in common finishes, including metallic driers, are approved by the Federal Drug Administration (FDA) for food contact as long as the finish is made so it cures properly. Lead and Mercury are, of course, not on this list. But, neither Lead nor Mercury is used in common finishes anymore”

He then goes on to say the following:

“In spite of the fact that no health problems have ever been reported, woodworkers and ,especially woodturners, continue to worry themselves about the food safety of finishes. This has resulted in many wooden objects receiving inferior, non curing mineral or vegetable oil finishes.”

Please make up your own minds about what you feel is safe. Believe me I really don’t care what you decide is best for your own personal use.

Again, this IS NOT a forum for your own personal Political Views!!!! If you have a problem with the FDA or if You Love the FDA please feel free to write your own blog and tackle that topic. But as far as this thread goes leave the politics out. I am only sharing information from a a source I found and am in no way advocating for or against the FDA or any other Government Entity. If you respect this I will respect You!

          Garcinia Cambogia Review: Are There Any Hydroxycitric Acid Side Effects?        

Los Angeles, CA -- (SBWIRE) -- 04/08/2014 -- This Garcinia Cambogia Review is about a secret ingredient that this popular product contains, known as hydroxycitric acid (HCA) and its effectiveness in weight loss. Many people have concerns about eventual hydroxycitric acid side effects, so this review answers all their questions and worries regarding the safety of this product.

There are multiple researches and tests made with the pure Garcinia Cambogia extract derived from the fruit, which contains 60% HCA. All of them confirm that HCA has two positive effects in people: it suppresses their appetite and burns excess fat, preventing more fat accumulation. This secret ingredient is secreting the fat through the urine. All clinical researches made confirm that there are absolutely no hydroxycitric acid side effects, if the product is taken in its 100% pure form.

100% pure Garcinia Cambogia Extract contains a proper percentage of at least 60% HCA. The supplement should be taken two or three times per day. The product must not contain preservatives, additives, fillers, GMO, gluten or binders. These type of fillers that some of the manufacturers add into the supplement, makes the product ineffective and can cause harmful negative effects. Customers, who would like to avoid any risk and to get really effective Garcinia Cambogia, should opt for its pure form. They need to select a product that is produced in a FDA registered cGMP facility.

The active ingredient HCA blocks the special enzyme, which is responsible for conversion of sugar into fat. It is an effective natural appetite suppressant that increases the level of serotonin. Some additional benefits of Garcinia Cambogia are control of cortisol levels, mood enhancement, bad cholesterol reduction, lowering of high blood pressure and other effects associated with overweight and obesity, such as easy maintenance of the reached results.

It is a completely safe and all natural weight loss product that requires no special diet or exercises to lose weight. A lot of diet specialists and doctors recommend this product to their overweight patients. Garcinia Cambogia is known as one of the most powerful fat blockers and fat burners that is clinically proven to be all natural and completely safe. It is an effective remedy for emotional eaters as well, because of its effect of serotonin level increase, so it can improve customers' sleeping patterns and mood. People report to have increase of energy and no food cravings after regular intake of this amazing supplement.

These multiple benefits make Garcinia Cambogia a more and more popular weight loss supplement today without any hydroxycitric acid side effects known.

People, who like to to know more about this doctor-recommended weight loss supplement, can look here for more information.

About Better Shape
Better Shape is dedicated to provide customers with the best quality products that can improve people's health and wellbeing. The young and motivated team search for the useful products that most people have interest in, and provides them with a comprehensive and detailed reviews to help them make an informed choice.

For more information on this press release visit: http://www.sbwire.com/press-releases/hydroxycitric-acid-side-effect/release-490262.htm

Media Relations Contact

BetterShape Support
Better Shape
Email: Click to Email BetterShape Support
Web: http://www.bettershape.org/

          Pure Garcinia Cambogia Extract: The Popular Diet Pills That Work Are Offered at a Discounted Price Now        

BetterShape.Org now offers pure Garcinia Cambogia extract at a discounted price. Garcinia Cambogia is a weight loss supplement that owes its double positive effect to the amazing hydroxycitric acid. The product works by burning body fat and curbing appetite, promoting a slim and attractive body. The Pure Garcinia Cambogia Extract offered by Better Shape is 100% natural, which means there are no preservatives, additives, GMO, blinders, fillers, or gluten.

St. Petersburg, FL -- (SBWIRE) -- 03/18/2014 -- These diet pills that work efficiently do not allow the body to accumulate fat rather than secreting it in the urine. The product includes 80mg of potassium and 80mg of calcium per serving, so regular diet pill intake will bring people many more additional benefits, such as the ones described below. Garcinia Cambogia is said to:

- Increase the levels of serotonin and control the enzyme called citrate lyase that is responsible for converting excess sugar into fat.
- Effectively support the healthy levels of lipids.
- Block the production of fat and suppress appetite, making people choose healthier foods. This prevents fat buildup, making success faster.
- Improve overall health and quality of life, successfully fighting all weight-related conditions.
- Help emotional eaters, improving their mood and sleeping habits.

Most importantly:

- It is recommended by doctors and is made in the US by a FDA registered company.
- It is all natural and completely safe for use with no side effects.
- It does not require exercise or to follow a special diet in order to lose weight due to its natural appetite suppressant properties.

Garcinia Cambogia Extract Pure is derived from a small exotic fruit called Garcinia Cambogia that grows in Indonesia, India, Africa, and southeast parts of Asia. It has been used in traditional local dishes for centuries, as its beneficial qualities have been known from a long time. The soup of Garcinia eaten before other meals helps locals feel full faster because HCA (hydroxycitric acid) curbs their appetite.

Studies show that people who take this extract regularly in the recommended dosage lose approximately four pounds per month. If appropriate exercising and dieting is included, it will be even more. The product is connected with other beneficial effects on people's health, such as reduction of cortisol (the primary stress hormone), reduction of bad cholesterol and triglycerides, and increase of good cholesterol.

Another study has shown the great results of this supplement when combined with a calorie restricted diet of 1,200 kcal a day. Obese people who followed this diet and took Garcinia cambogia for a period of two months were able to lose 14 pounds and reported reduced appetite.

The recommended dose of Garcinia Cambogia Extract Pure is between 800 and 1,600 mg before each meal, but the total intake per day should not exceed 3,000 mg. Since this diet pill is a strong appetite blocker, it is recommended to start with one pill, taking it about a half an hour to two hours before each meal, while drinking a lot of water throughout the day to help the body faster adjust to the changes. After a week or so, people can increase their servings to two capsules (1,600 mg) in order to boost the weight loss effect.

All who are interested in finding more information on this effective diet supplement can visit www.bettershape.org and http://www.amazon.com/Garcinia-Cambogia-Extract-Pure-Caps/dp/B00HS3IB8A.

About BetterShape
BetterShape offers high quality diet supplements that help improve people's health and effectively fight obesity. The company is focused only on all natural products without any chemicals, providing all clients with the opportunity to enjoy great health and quality of life.

Media Relations Contact

For more information on this press release visit: http://www.sbwire.com/press-releases/garciniacambogiaextract/release-477860.htm

Media Relations Contact

Press Dpt
Email: Click to Email Press Dpt
Web: http://www.bettershape.org/

          Past Vogue CFDA winners doing well        
In advance of announcing the winner of the 2006 CFDA/Vogue Fashion Fund Award ($200,000), Vogue Editor in Chief Anna Wintour gave a run-down of what’s become of winners past. She also spoke very highly of the award’s career-boosting effects. “In only the third year of the competition, we know that to win a first or runner-up prize is to receive a substantial professional boost. The inaugural

          Kime Daha Çok Yakışmış: Adriana Lima vs. Shay Mitchell        
Koğuş kalk, gıybet var!

Aslında birazdan bahsedeceğim kıyafet pişti sayılmaz, aynı şey değiller ama aynı renk ve aynı konsept olunca uydurayım dedim. Ay içimden çan çan konuşmak geldi, kılıfına uyduruverdim işte. 

Adriana Lima ile başlıyoruz. Geçen ayın başında CFDA Fashion Awards'a giderken bu Urban Zen beyaz tulumu giydiğinde dikkatimi çekmişti aslında. Teoride tiril tiril, tam yazlık, aşırı şık olması gerekirken bi eğretilik var ama çözemiyorum. Halbuki o katanalığı gitmiş, majyajı abartmamış, saçı desen cool, narin bi çiçek gibi Adriana ama o efil tulumda bi sorun var. 

Şimdi gelelim ikinci beyaz efil tulumlu falso ismimize.

Tarzına bayıldığımız Shay Mitchell ise Much Music Awards pembe halısında bu şeffaf tulumla karşılıyor bizi. Yine teoride her şey harika. İç gösteren kumaş, beyaz şık bi mayo, harika bi hatun. Ama canlanınca hiç de iç açıcı bi görüntü yok ortada. Hele o kafasını defalarca highlight kutusuna batırıp çıkarmış gibi görünen makyajının hali nedir? Saten çantası, ucu dekolteli ayakkabılarıyla cesur bi sünnet annesinden farksız geldi gözüme.

Ä°kisine de yakışmamış ama ben şimdi herkese yakışacak bi kaç beyaz kıyafet önereceğim. Ayrıca günlük giyilebilecek aşırı rahat bi beyaz pantolon arıyorum, gören duyan söylesin. 

Önü çiçekli beyaz tulum
Omzu açık mini romantik tulum (tam tatil akşamılıkkkk)
Uzun beyaz şık tulum (al düğüne giy gelin çıldırsın)
Uzun çiçekli salaş tulum
Beyaz uzun kollu gömlek elbise (Valla bunu çok ucuz ve şık diye koydum ve %90 alıcam da, üzerimde görürseniz aha linki)
Kırmızı kareli minnoş tulum (Ay bu da konudan bağımsız ama aşırı beğendim, yazlığa gidecek olan alsın)

Hadi bi de adettendir kime daha çok yakışmış anketi yapalım.

Beyaz pantol önerilerinizi, nadide yorumlarınızı ve yazı isteklerinizi bekliyorum. Danimarka'dan döndüğümde söz bu yazıya gelen isteklerden birini yazıcam!

          Creation Technologies Launches FDA UDI Compliance Program in Global Manufacturing and Design Operations        

Electronic product design and contract manufacturing leader demonstrates commitment to medical OEMs in all ten of its manufacturing locations

(PRWeb October 27, 2016)

Read the full story at http://www.prweb.com/releases/2016/10/prweb13801283.htm

          Creation Technologies Receives FDA Registration for California Manufacturing Facility        

Medical OEMs Gain Additional Option for Risk Mitigation through Leading Contract Manufacturer

(PRWeb June 17, 2014)

Read the full story at http://www.prweb.com/releases/creation-technologies/fda-registration/prweb11948953.htm

          Creation Technologies Receives FDA Registration in USA        

Leading Electronics Manufacturer Demonstrates Quality Expertise

(PRWeb November 04, 2013)

Read the full story at http://www.prweb.com/releases/2013/11/prweb11289689.htm

          Creation Technologies Receives FDA Registration        

Award-winning electronics manufacturer demonstrates commitment to Medical Devices industry.

(PRWeb May 30, 2013)

Read the full story at http://www.prweb.com/releases/2013/5/prweb10773946.htm

          Regulatory and Risk Manager        
Overview: We are currently working with a ground breaking medical device manufacturing company, who are in a state of growth and therefore looking to recruit a Regulatory and Risk Manager to their team based near Warwick. Your purpose in this role will be to develop a regulatory strategy to support all target markets, and to maintain regulatory compliance as required. You will be responsible to the Director of Quality and Regulatory Affairs. Essential Candidate Experience: · Experience as a Regulatory Manager with ideally some team leading or management experience. · 510K and FDA submission experience Key Responsibilities To drive the company to deliver sufficient depth of evidence to demonstrate regulatory compliance. To drive the vigilance processes (PMS feedback, regulatory changes, adverse events, competitor information, literature searches) required in Europe, US and other relevant markets. To deliver PMS report, Vigilance Report and clinical evaluation report in line with the relevant plans. To define the appropriate regulatory pathways for entry into global markets and support other members of the company in understanding the regulatory pathways. To provide advice on possible approaches to de-risking and accelerating project completion. To provide advice on approaches taken by other companies for comparable products in satisfying regulatory requirements. To provide risk assurance support into the design and development process, to assure risk consideration and acceptability as ALAP throughout the product development lifecycle. To provide managerial leadership for RA team members, ensuring that there is a common agreement on strategy, priorities and deadlines, and to maintain a strong understanding of delivery against plans and targets. Requirements/Qualifications Strong understanding of regulatory standards and their implementation in a Medical Device framework i.e. Medical Device Directive (93/42EEC), ISO 13485, ISO 14971, IEC 60601, IEC 62366, IEC 62304, 21 CFR 820,21CFR 807, 21 CFR 11. Experience in working with PEMS (Programmable Electrical Medical Systems) or equivalent high-integrity software-intensive systems i.e. complex devices requiring multidisciplinary development effort (mechanical engineering, software, electronics, system integration, pneumatics, fluid mechanics, etc.). Experience of working with risk management, regulatory requirements, document management systems, issue management systems. Trained in application of IS014971. Ability to work with external bodies. Good team player and effective communicator. Flexible approach to hours. Ability to operate at strategic and operational levels. Ability to identify strategic and operational issues and develop plans to address. Ability to lead; demonstrating assertiveness, team building and management skills. Attention to detail. Effective communicator. Articulate, persuasive personality. Extensive experience working in product development & delivery. Sound technical knowledge of product base and application. Degree or equivalent experience in appropriate subjects.
          Senior Microbiologist Validation Specialist        
Senior Microbiologist Validation Specialist - Northampton Opportunity : Are you currently working within the pharmaceutical industry managing a microbiology lab? Does your experience include IQ, OQ, PQ of instruments cleaning validation? Want to work for a growing company? Yes then this is the role for you. Your role as a Senior Microbiologist Validation Specialist based in Northampton will involve managing the site microbiology. Duties and responsibilities include: Responsible for the instrument procurement and supplier assessment. SOP preparation and review. IQ, OQ, PQ of instruments cleaning validation. Preparing protocols and reports for cleaning validation, water system, calibration, IQ, OQ, PQ of instruments. Validation of microbial limit test. Microbiological analysis. Writing and reviewing Microbial validation protocols and reports. Aseptic area qualification by environmental monitoring of new manufacturing facility. Preparation of COA for microbial analysis. This is a full time permanent job opportunity paying between £28,000 - £30,000 per annum and great benefits. There is a lot of career development as the company has set up a brand new production site so it is a great time to join a growing business and be able to play a key role in the success of the company and become a pivotal team member for the future. Skills: To apply for the Senior Microbiologist Validation Specialist role you will have the following: Degree or equivalent qualification in a scientific subject. 8-9 years experience in Microbiology. Experience of GMP, GDP and FDA CFRs. How to Apply: To apply for this one off opportunity, please send a word copy of your CV to me now by clicking on the Apply button or call me for a confidential chat. If this sounds like the role for you or a colleague then please don’t hesitate to contact us. If we manage to successfully fill a permanent placement from your recommendation then we will send you a cheque of £300. We also have many incentive schemes for referring contractors/temp staff so please contact us with the referral and we can provide you with more information. For a list of our current vacancies, please visit www.qualitystart.co.uk If you do not hear from Quality Start within 2 weeks your CV has not been short listed for this role. Quality Start are acting as a specialist recruitment consultancy for this role.
          fat children and your teenager        
Children and obesity

Someone once said, "Health is wealth." This statement is true given that there are more teens obese today than it was 20 years ago which could lead to various problems in the future such as diabetes and heart disease.

The best way to lose those extra pounds is by working out and going on a diet. Unfortunately, a lot of teens find it difficult to balance the time, which is why many have turned to weight loss pills.

Weight loss pills are designed to make a person lose weight by suppressing one's appetite. The only drug approved by the FDA for use on teens between the ages of 12 and 16 is Xenical, which was once only used by overweight women.

When teens decide to eat food, the main ingredient, Orlistat blocks the absorbing of fat and releases this out through the intestine as waste. In a comparative study done between those who took the drug and those on a placebo diet, results prove that the people here lost an average of seven to eight pounds, which is much higher than the other group.

Since the body needs fat, teens are advised to compensate for the losses by having this replenished during the three regular meals of the day.

The test group did not just take Xenical to get the results. These people also had to follow a strict diet plan and exercise to maintain the weight that was lost. One of the things to also watch out for are the side effects such as gas pains, nausea and wet stools that will prompt the person to frequently go to the toilet.

Xenical is a prescription drug. This means that the parents of the teenager or that person cannot just buy this off the counter. It is only after a thorough medical examination has been conducted that the doctor will allow the patient to use this kind of medication.

Will someone who takes this get the same results like those in the test study? The answer is no. This figure could be higher or lower which really depends on the patient's metabolism.

Patients are advised to discontinue the use of Xenical if there are no signs of improvement after six months. Doctors may have to try something stronger such as the next one called Meridia.

Meridia is a diet pill that sends a signal to the brain making the person think that the body is already full after eating only a few servings. The ingredient that makes this happen is called Sibutramine. It works much differently than Xenical with the same objective of losing the excess weight.

There are two other diet pills that the patient may take. These are namely Bontril and Didrex. These ingredients of these two drugs are different and the doctor may increase the dosage if there are no signs of improvement.

Unlike Xenical and Meridia, both of these pills have certain ingredients that are quite addictive so this can only be used for a short period of time. A gradual decrease in the dosage is also done to prevent withdrawal symptoms.

Diet pill such as those mentioned are only used for teens that are obese. Those who are overweight will have to go on a diet and exercise given that people at this young age can still engage in strenuous activity unlike people two or three times that age.

Visit the Free Tips Online website to learn about swimming tips and work out tips.

childhoodobesitystatistics: childrens obesity

childhoodobesitystatistics: childrens obesity

Article Source: www.articlesnatch.com

Peter Abbott has helped thousands of families tackle the distressing issue of children and obesity.  His website at http://www.children-and-obesity.com will provide parents with a guaranteed solution to the "single greatest tragedy facing our society today" (Former President Bill Clinton)
          Why You Shouldn't Trust Calorie Counts        

Yes, it’s possible to lose weight eating only Twinkies, provided that your calories in are less than your calories out. And it’s that logic that leads many people to conclude that calories are simple math. Even astrophysicist Neil deGrasse Tyson tweeted, "A weight-loss book by physicists would be one sentence long: 'Consume calories at a lower rate than your body burns them.'" Trouble is, things are not that straightforward.

Calories In

Calories in Muffins

<!DOCTYPE html PUBLIC "-//W3C//DTD HTML 4.0 Transitional//EN" "http://www.w3.org/TR/REC-html40/loose.dtd"><html><body><p>Calorie counts are everywhere these days, from <a href="http://www.nytimes.com/2014/11/25/us/fda-to-announce-sweeping-calorie-ru... rel="">fast food menus</a> to fitness trackers. You might even be able to rattle off the calories in a cup of spinach. But what exactly is a calorie?</p><p>In short, it&rsquo;s a measurement of energy; the &ldquo;calories&rdquo; seen on nutrition labels describes the <a href="http://www.scientificamerican.com/article/how-do-food-manufacturers/" rel="nofollow">amount of energy</a> needed to heat up a gram of water by one degree Celsius. But the energy in the cranberry&nbsp;<a href="http://greatist.com/eat/healthy-muffin-recipes" rel="nofollow">muffin</a> you just ate doesn&rsquo;t go to heating up water; instead, it provides fuel for a number of processes in the body, including staying alive and breathing. So figuring out how many calories are in that muffin is a bit more complicated.</p></body></html>

How Calories Are Measured

To determine the total energy content of a food, scientists use a fancy-pants piece of scientific equipment known as a bomb calorimeter. Into this device goes our muffin, which gets completely incinerated. During that muffin-burning process, the bomb calorimeter measures the heat produced. This number represents the total amount of energy—or what is known as the “gross energy”—of the muffin.

But gross energy isn’t very helpful in indicating how much energy humans can actually get out of foods, because human digestion isn’t as efficient as a bomb calorimeter. Our digestive systems produce waste products and can’t completely break down all foods, which means that not all of the gross energy in food goes to fueling our bodies.

When you’re looking at the calorie count on muffin’s nutritional label, you’re not seeing the gross energy. What you’re seeing is the amount of energy that’s up for grabs by your digestive system, or metabolizable energy (ME). Since this is tricky to measure, we have to rely on estimates, which have been approved by the FDA as accepted ways that food manufacturers can calculate the calories posted on food labels.

One way to estimate ME involves taking the gross energy and adjusting that number downward to account for waste and digestive inefficiency. Foods containing fats and simple sugars, (like doughnuts) are fairly easy for your body to digest, so their metabolizable energy is pretty darn close to their gross energy. However, other foods with complex carbs and fiber (think a whole-grain bran muffin) take a bit more digestive power to break down, hence their ME is much less than their gross energy.

The most common method used for calculating ME is known as the Atwater System. This method uses a series of factors derived from 19th century experiments to give an approximation of the energy per gram of protein, fat, carbohydrate, and alcohol. To calculate total calories in a muffin, food manufacturers count up the number of grams of fat, protein, carbohydrate, and alcohol; multiply each by its respective factor (nine calories per gram of fat, four calories per gram of protein, four calories per gram of carbohydrate, and seven calories per gram of alcohol); and add up the totals.

Where ME Gets Murky

<!DOCTYPE html PUBLIC "-//W3C//DTD HTML 4.0 Transitional//EN" "http://www.w3.org/TR/REC-html40/loose.dtd"><html><body><p>Though&nbsp;the original system remains in widespread use more scientific research ">www.ncbi.nlm.nih.gov%2Fpubmed%2F22760558%22+rel%3D%22%22%3EDiscrepancy+B... has been done since Atwater&rsquo;s original experiments to come up with &ldquo;specific factors&rdquo; for particular food groups such as dairy products.</p><p>Scientists are learning&nbsp;that&nbsp;calories calculated from the Atwater factors are <a href="http://greatist.com/health/calorie-counts-misleading-research-022113" rel="nofollow">more accurate</a> for certain diets and certain foods than others. One study found that the Atwater general factors overestimated the energy content of a low-fat, high-fiber diet by 11 percent .</p><p>More">www.ncbi.nlm.nih.gov%2Fpubmed%2F18065582%22+rel%3D%22%22%3EAccuracy+of+t... recently, USDA researchers discovered that Atwater factors overestimate the calories in a serving of raw almonds. Food labels typically list a calorie count of 160 to 170 calories per ounce of the nut, but this study showed that our bodies only absorb about 129 calories .</p><p>But">www.ncbi.nlm.nih.gov%2Fpubmed%2F22760558%22+rel%3D%22%22%3EDiscrepancy+B... this may not apply to almond butter since less-processed foods give up their energy less readily. Whereas nut butter is already ground and therefore kind of &ldquo;pre-digested,&rdquo; our digestive systems have to work a lot harder to break down whole almonds. Same goes for cooked foods: Raw foods, ounce-for-ounce, take more energy to break down than <a href="http://www.scientificamerican.com/article/science-reveals-why-calorie-co... rel="nofollow">cooked foods</a> (one reason some people embrace a <a href="http://health.usnews.com/best-diet/raw-food-diet" rel="nofollow">raw food diet</a>).</p><p>In addition to these factors, scientists are also exploring others that may impact the accuracy of the <a href="http://www.scientificamerican.com/article/science-reveals-why-calorie-co... rel="nofollow">almighty calorie</a>, such as gut bacteria, the immune system, and certain genetic variations.</p></body></html>

Calories Out

Treadmill Calorie Tally

<!DOCTYPE html PUBLIC "-//W3C//DTD HTML 4.0 Transitional//EN" "http://www.w3.org/TR/REC-html40/loose.dtd"><html><body><p>While it&rsquo;s a tricky business to calculate the calories in food, figuring out the other side of the equation may make busting a sweat on the <a href="http://greatist.com/move/reasons-treadmill-doesnt-suck" rel="nofollow">treadmill</a> or powering through a heavy <a href="http://greatist.com/fitness/ladies-lifting-weights-wont-make-you-bulky" rel="nofollow">weightlifting</a> session seem easy.</p><p>Measuring calorie expenditure, like measuring the calories in foods, is pretty convoluted. While there are a couple of methods that are pretty darn accurate for determining a person&rsquo;s daily burn, these are very expensive and/or involve some specialized equipment&mdash;not very practical for the average person .</p><p>So">www.ncbi.nlm.nih.gov%2Fpubmed%2F21892558%22+rel%3D%22%22%3EEnergy+Expend... we have to turn to easier, albeit less accurate, ways to tally daily energy expenditure. The <a href="http://www.calculator.net/calorie-calculator.html" rel="nofollow">Mifflin St. Jeor</a> equation, which takes into account age, height, current weight, and sex, is the go-to for registered dietitians and <a href="http://greatist.com/fitness/best-health-fitness-apps" rel="nofollow">weight-loss apps</a> to estimate your caloric needs. The equation spits out a number that gives a rough estimate of a person&rsquo;s resting daily energy expenditure (REE, or the <span >energy required to simply exist, couch-potato-style)</span>. This is multiplied by a <a href="http://35-210-203-f13.wiki.uml.edu/file/view/Lab+3_EER+and+BMI.pdf" rel="nofollow">physical activity factor</a> (such as multiplying by 1.2 for someone who does no physical activity and up to 1.9 for someone who has an intensely physical job) to calculate a rough guess of how many calories a person expends on a daily basis&mdash;but it&rsquo;s only a guess.</p><p>Altogether, a person&rsquo;s daily <a href="http://www.nal.usda.gov/fnic/DRI/DRI_Energy/107-264.pdf" rel="nofollow">energy expenditure</a> looks like this:</p><p><em>basal energy expenditure + physical activity + non-exercise activity thermogenesis + thermic effect of food = total daily energy expenditure</em></p><p>If that formula reads like Greek, don't worry. Let's walk through each of these components.</p></body></html>

1. Basal Energy Expenditure (BEE)

<!DOCTYPE html PUBLIC "-//W3C//DTD HTML 4.0 Transitional//EN" "http://www.w3.org/TR/REC-html40/loose.dtd"><html><body><p>This is basically REE, but it's measured in a slightly <a href="https://www.acefitness.org/blog/616/bmr-versus-rmr" rel="">different way</a>. BEE is&nbsp;by far the largest part of your daily burn, accounting for<a href="http://www.fao.org/docrep/007/y5686e/y5686e04.htm" rel="nofollow"> 45 to 70 percent</a> of total daily energy expenditure (TDEE). It&rsquo;s mostly determined by how much <a href="https://books.google.com/books?id=MVJPAQAAQBAJ&amp;pg=PA20&amp;lpg=PA20&... rel="nofollow">lean body mass</a> you have (your total weight minus fat mass), and age, sex, genetic variations, and certain conditions (such as thyroid problems) also <a href="http://www.nal.usda.gov/fnic/DRI/DRI_Energy/107-264.pdf" rel="nofollow">factor in</a>. And yes, your body does slow the burn when in &ldquo;starvation mode,&rdquo; which can be triggered by too few calories and/or too much exercise. It&rsquo;s your body&rsquo;s way of protecting itself by pumping the breaks on losing more muscle mass Metabolic Adaptation to Malnutrition. Carbonnel, F. Annales De Medecine Interne, 2000; 151:644-651..</p></body></html>">www.ncbi.nlm.nih.gov%2Fpubmed%2F2017606%22+rel%3D%22%22%3EThe+Impact+of+...

2. Non-Exercise Activity Thermogenesis (NEAT)

<!DOCTYPE html PUBLIC "-//W3C//DTD HTML 4.0 Transitional//EN" "http://www.w3.org/TR/REC-html40/loose.dtd"><html><body><p>The neat thing about NEAT is its ability to bump up your burn without the sweat factor. NEAT, which includes energy spent on&nbsp;<a href="http://greatist.com/fitness/unexpected-ways-cardio-exercise" rel="nofollow">daily activities</a>&nbsp;from fidgeting to cooking to Xbox-ing, can differ between individuals by up to 2,000 calories per day&nbsp; ">www.ncbi.nlm.nih.gov%2Fpubmed%2F16439708%22+rel%3D%22%22%3ENon-Exercise+.... Fidgeting alone can burn up to 350 calories a day, and some scientists have hypothesized that lack of NEAT has contributed to America&rsquo;s obesity epidemic .</p></body></html>">www.ncbi.nlm.nih.gov%2Fpubmed%2F16439708%22+rel%3D%22%22%3ENon-Exercise+...

3. Physical Activity

Here’s what most of us picture when we think “calories out”: purposeful physical exercise, like Spinning class or a pick-up soccer game. While this contributes to TDEE, it varies between individuals. For most people, it’s a small chunk of daily caloric burn, but for mega-endurance athletes, it can be a pretty big piece of the pie.

4. Thermic Effect of Food (TEF)

<!DOCTYPE html PUBLIC "-//W3C//DTD HTML 4.0 Transitional//EN" "http://www.w3.org/TR/REC-html40/loose.dtd"><html><body><p>Strangely, food itself can contribute about <a href="http://www.fao.org/docrep/007/y5686e/y5686e04.htm" rel="nofollow">10 percent</a> of total daily energy expenditure. The thermic effect of food (TEF)&nbsp;is the work expended by the digestive system to&nbsp;<a href="http://greatist.com/health/small-meals-weight-loss-myth-062513" rel="nofollow">digest food</a>. Fats require relatively little energy to digest, while proteins and complex carbohydrates require quite a bit more.</p><p>Despite lots of hype to the contrary, there&rsquo;s no evidence that eating smaller, more frequent meals will bump up caloric burn or help with appetite control Evidence for Efficacy and Effectiveness of Changes in Eating Frequency for Body Weight Management. Kant, A. K. Advances in Nutrition, 2014; 5:822-828.">www.ncbi.nlm.nih.gov%2Fpubmed%2F21123467%22+rel%3D%22%22%3EThe+Effect+of.... Instead, it&rsquo;s&nbsp;<a href="http://greatist.com/health/small-meals-weight-loss-myth-062513" rel="nofollow">how much and what</a>&nbsp;we eat that determines the energy expended by TEF.</p></body></html>

The Takeaway

In short, the “calories in versus calories out” equation works, however it's pretty much impossible for an individual to measure either with precision. So do what works for you.

Given the inaccuracies, counting calories may seem like a waste of time, but plugging your foods into a calorie-tracking app isn’t completely pointless for everyone: There’s some evidence that writing down food intake can contribute to weight loss Self-Monitoring in Weight Loss: A Systematic Review of the Literature. Burke L.E., Wang J., and Sevick M.A. Journal of the American Dietetic Association, 2011 Jan;111(1):92-102. because food diaries help people pay attention to their choices and provide a sense of accountability. For the more numerically inclined, tracking calories, quality of foods, and weight changes will give a big picture of how meals and snacks translate into weight changes, even if calorie labels aren’t foolproof.

And if you like crunching numbers but question the whole calorie-counting thing, there are several alternative tools, such as the NuVal and Orac scales, that can help you judge the healthfulness of foods without relying on a running tally of calories.

For others, for ignoring calories completely and instead focusing on consuming whole, nutritious foods may be better. In addition to providing tons of good-for-you nutrients, these kinds of foods typically take more work to digest. If you’re looking to lose weight, try playing with proportions—bump up the fraction of unprocessed foods in your diet and see what happens.

Jessica Redmond
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          More Britney Civil Rights Violations        
In addition to all of the civil rights violations I mentioned in my post below, Britney was treated with drugs that are not FDA approved as safe and effective for use in the treatment of alleged bipolar disorder. Either separately, or in combination. Britney is literally being used for drug experimentation without her informed consent, […]
          FDA, lösemi ile savaşmak için yeni bir gen tedavisini onayladı        
Geçtiğimiz hafta Amerikan Gıda ve İlaç Dairesi’nin Heyeti (FDA), Daire’nin oybirliğiyle, lösemi ile savaşmak üzere hastanın kendi hücrelerini genetik olarak değiştirecek bir tedaviyi onaylayacağını bildirdi. FDA onayı verirse, ilk kez böylesi bir tedavi, tıpta “yaşayan ilaç” çağının başlangıcı olacak. Böylece, doğal bağışıklık sistemimizi kuvvetlendirip, önceden yenilmez olan hastalıkları baskılama yeteneğini iyileştirmek için teknolojiyi koşturacağız. CTL019 diye bilinen bu lösemi tedavisi pazara ulaşan ilk gen terapisi olsa da pek çoğu sırada bekliyor. Saldırgan bir tip beyin tümörü, miyeloma ve diğer lösemi türleri için tedaviler geliştiriliyor. Bu teknik kişiye özel ilacın gerçek bir örneği: her hasta için kendi hücrelerinden yaratılacak tedavinin emsalsiz bir türü. Hücreler tıbbi personel tarafından alındıktan sonra, dondurulup terapinin uygulayan Novartis’e gönderiliyor. İşlendikten sonra da tekrar dondurulup tıbbi merkeze geriye gönderiliyor. Tedavi onaylanırsa FDA için bir ilk olacak. Şaşırtıcı deney sonuçları ışığında, tedavinin onaylanması, açıkçası, çok da sürpriz niteliğinde..
          Will the Trump presidency mean the end of FDA drug regulation?        

          BioethicsTV: Pure Genius is Purely Corrupt        

by Craig Klugman, Ph.D.

In this week’s episode (Season 1, Episode 7 -12/8), an FDA reviewer trades a case so that she can review a compassionate use request for a new drug at the hospital where her husband is the chief of staff. Her spouse was even was a participant in the proposal presentation to her for approval. Meanwhile, the owner of the hospital asks his chief of staff to be his doctor for his neurodegenerative disease—serving as the physician for his boss, in an area that is outside his specialty.…

          BIOETHICS TV 10/27 – Modern miracles, body hacking, and sex trafficking        

by Craig Klugman, Ph.D.

Pure Genius (Seasons 1, Episode 1)

This new TV show might be the ethicists worst nightmare. The show opens with Dr. Mulroney at a hearing where he admits to giving a patient an unapproved FDA drug to a patient who died. He is dismissed. The point of this opening scene is to present medicine as too conservative, too stodgy, and not willing to take risks for innovation.

The second presents a case takes in an Oakland, CA hospital where a 15-year-old girls is unresponsive in a “coma” for some unknown reason.…

          Do the EPA Exposure Studies Violate Do No Harm and Informed Consent?        

by Craig Klugman, Ph.D

A government agency recruits elderly and sick patients for an important research study. In a controlled environment, subjects are exposed to airborne pollutants at levels many times higher than found in the real world. Some pollutants are considered so dangerous that the FDA considers any exposure to be dangerous.

Such a scenario may sound like a historical case study of human subjects abuse, but such studies are actually the subject of an 18-month review by the EPA on ethical conduct of research.…

          Eric Egozi, MD, is Leading Clearwater, Florida Plastic Surgeon Provider of Sculptra Aesthetic, an Injectable Facial Filler Just Approved by the FDA for Cosmetic Use        

On July 28, 2009, the FDA approved Sculptra® Aesthetic, an injectable poly-l lactic acid dermal filler, for treating facial aging with results lasting up to two years--about twice as long as hyaluronic acid fillers. Sculptra is much more difficult to inject than Botox or other facial fillers, so finding an experienced provider is key. Plastic surgeon Eric Egozi, MD, has been treating patients with Sculptra since 2007 and has more experience with it than any other plastic surgeon in the Tampa Bay area.

(PRWeb October 20, 2009)

Read the full story at http://www.prweb.com/releases/2009/10/prweb3053344.htm

          Tens Handheld Electronic Pulse Massager Unit Review        
Tens Handheld Electronic Pulse Massager Unit Review

Today I am reviewing a different type of product. This is an electronic pulse massager. It comes with the remote and 4 different sticky pads. The directions are very useful and straight forward. It has settings for sole, leg, waist etc so you know exactly where you should place it. The only 2 spots that you cannot put this massager is over your heart and your head.

To begin you put the sticky pads on your body. I did this on my feet as they were sore. I stuck them to the soles of my feet and used the sole mode on the massager. It then has a turn dial to turn up the pulses. I couldn't go past number 2 as it got uncomfortable. At 2 though it was comfortable. It pulses and my toes would twitch which was interesting. The session lasted 15 min. I did another just because but you shouldn't do more then 2.

My feet did feel less sore after and the next day.

My husband used this on his lower back and didn't think one pad was working. He turned it up and was uncomfortable so he put it back down to 2. He then said it felt great and worked just fine.

Because there are 2 separate ports for the sticky pads 2 people can use it 2 different ways.

Overall this is an interesting product. It is not a normal massager that you would think but makes an interesting twitchy feeling. My dad and mom use this for their shoulders and they both avoided surgery by using this product.

Santamedical electronic tens pulse massager features microcomputer controls therefore you can easily adjust massager with available six automatic programs and three diverse styles of modes. The device has dual channel system; hence it can easily work two areas at one time. Recommended by doctors, this is best handheld tens massager in the market. Buy with Confidence, Santamedical unit is FDA approved. Quality - Santamedical unit is designed with quality and durability in mind. Our factory is ISO-9001 certified. It conforms to international medical standards of excellence in manufacturing.
          Eco Friendly BPA Free Sports Water Bottle Review        

Eco Friendly BPA Free Sports Water Bottle Review

These water bottles are really cool because they not only come in fun bright colors but they roll up when empty! They also have a handy hook on the side which can be attached to your bag or belt! I am taking 2 of these on my honeymoon because we can hook them onto our bags during the day and roll them up for easy storage when we are done with them. 

Everyone knows that drinking water is healthy and that's why you try to get your daily 8 glasses of H20. You carry a water bottle around or worse yet you buy water bottles every day! Stop wasting money on plastic bottles you lose all the time and feeling guilty about throwing your empty plastic bottles into the environment. Whether you're running, jogging, cycling, hiking, snowboarding, skiing, mountain climbing, camping or working out hard in the gym, the Mindbody Active bottle won't get in the way and you'll have peace of mind knowing that you're treating your body right! Our portable bottles are more compact and easier to transport than any other water bottle! When empty the Mindbody Active 20 oz bottle can be folded, rolled, or flattened to 1/4 its original size for convenient travel transportation. Simply refill and watch as this durable bottle stands straight up retaining its original shape.

- BPA Free
- Phthalate Free
- FDA Approved
- Eco Friendly
- Reusable
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- Recyclable
- Lightweight
- Dishwasher Safe
- Microwave Safe
- Freezer Safe
- 100% Food Grade Silicon
Did You Know? 
Most plastic water bottles are made with harmful chemicals such as BPA and Phthalate. Researchers have proven these toxic chemicals can seep into your water from your plastic bottle, causing long term health effects such as cancer. Equip yourself and your loved ones with a BPA / Phthalate FREE 100% food grade silicon water bottle. Stay hydrated with peace of mind knowing your water is chemical free. 

Why Mind Body Active (MBA)? 
MindBody Active's goal is to help you live an active, healthy and environmentally clean life. 
All our products are environmentally safe and promote an active and balanced lifestyle.

          Does Alli Work?        
Does alli work as a weight loss pill? The quick answer seems to be yes, but there is a downside, so read on.

Alli is the over-the-counter name for orlistat which is also available in prescription form as Xenical. If you are going to ask for it you may like to know that it is pronounced like ally, not alley. It is essentially a fat blocker. It works by preventing the body from absorbing the fat from the foods that we eat, and it is the one freely available drug that has FDA backing for its claims to aid weight loss. You might think you could eat all the fatty foods you liked and then take alli to negate the effect but sadly that is not true. It should always be used in conjunction with a low fat diet plan under the supervision of a doctor.

The amount of weight loss achieved with alli is variable. In one study involving one-year clinical trials, between 35.5% and 54.8% of subjects attained a 5% or greater decrease in body mass, although we do not know how much of this mass was fat. Between 16.4% and 24.8% of the subjects achieved a 10% or more decrease in body mass. In combination with a calorie controlled diet, the effects could be expected to be greater. It was also shown to reduce the risk of developing type 2 diabetes. The participants regained an average of one third of the weight that they had lost after stopping alli, but this is typical of most dieters.

The main disadvantage of alli is the side effects which center around digestive and bowel problems. The higher the fat content in the diet, the greater these side effects are likely to be, as the undigested fat is expelled from the body. Flatulence, loose stools and bowel incontinence can result, especially in the early stages before the body is accustomed to the drug. The manufacturer's website warns, "You may feel an urgent need to go to the bathroom. Until you have a sense of any treatment effects, it's probably a smart idea to wear dark pants, and bring a change of clothes with you to work." You really need to want to lose weight to take alli!

However these side effects are reduced if you stick to the recommended low fat diet and as the manufacturers hint, the potentially embarrassing side effects can even be helpful in encouraging you to keep to your diet. Always remember that alli does not claim to work without consistent efforts toward weight loss from you. What they do claim is that it can improve your weight loss by up to 50%. That would mean a person who lost 10 pounds without taking alli would lose 15 pounds taking it. It boosts your weight loss and rewards your efforts with better results than you could get by yourself. Note though that individual results will vary and are not guaranteed.

Sadly there is no magic diet pill that will melt away your excess pounds while you sleep, but alli is a pill that has documented results. If you are determined to lose weight and have been struggling with diets without much effect, it may be a good time to discuss it with your doctor and find out does alli work for you.
          ÐšÑ€ÐµÐ¼-лубрикант для игрушек pjur Toy Lube 100 мл        
Особенностью крем-лубриканта для игрушек pjur Toy Lube 100 мл является во-первых - его кремовая консинстенция. Во-вторых комбинированная основа (вода и силикон). Формула лубриканта успешно создана для наилучших впечатлений! Крем-лубрикант для игрушек pjur Toy Lube очень удобен в нанесении. Он не разтекается, а будет четко зафиксирован там, где Вы его нанесли! Это важное преимущество данного продукта!Формула крем-лубриканта для игрушек pjur Toy Lube пользуется огромной популярностью во всем мире, она известна своими исключительными свойствами. Компания «Pjur» использует ингредиенты с максимально возможными уровнями чистоты и является синонимом бескомпромиссного высокого качества. Все продукты компании разработаны внутри страны и производятся на 100% в Германии без исключения. Pjur group зарегистрировала и сертифицировала все свои продукты в соответствии с официальными международными требованиями для соответствующих категорий продуктов, включая требования, установленные Европейским Союзом, FDA и TGA. Объем (мл.): 100 Производитель: Pjur Страна производства: Германия
          MOUSTACHE BLACK CHEVRON Paper Straws - Party Paper Straws - Wedding - Birthday Decorations by Limprime        

2.95 USD


You can decorate delicious desserts, beverages or make food appear more appetizing. Great for any crafting project.


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- Biodegradable and FDA Approved paper and ink
- Good quality and durable

          BLACK STRIPED - Black Striped Paper Straws - Party Paper Straws - Wedding - Birthday Decorations by Limprime        

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You can decorate delicious desserts, beverages or make food appear more appetizing. Great for any crafting project.



- DIMESIONS: 7 3/4"
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          SILVER STRIPES - Silver Horizontal Stripes Paper Straws - Party Paper Straws - Wedding - Birthday Decorations by Limprime        

2.95 USD


You can decorate delicious desserts, beverages or make food appear more appetizing. Great for any crafting project.



- DIMESIONS: 7 3/4"
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          COLOR POLKA DOT - Color Polka Dots Combination Paper Straws - Party Paper Straws - Wedding - Birthday Decorations by Limprime        

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          PINK GOLD - Gold Stripes, Gold Chevron, Pink Chevron and Solid Pink Paper Straws - Party Paper Straws - Wedding - Birthday Decorations by Limprime        

2.95 USD


You can decorate delicious desserts, beverages or make food appear more appetizing. Great for any crafting project.



- DIMESIONS: 7 3/4"
- Biodegradable and FDA Approved paper and ink
- Good quality and durable

          5,000 Pounds of pine nuts recalled due to possible Salmonella        

U.S. Food and Drug Administration says that the Wegmans supermarket chain is recalling 5,000 pounds of pine nuts from Turkey due to possible salmonella contamination. The FDA said that the pine nuts are linked to at least 43 cases of salmonellosis in California, New York, New Jersey,  Maryland, Pennsylvania and Virginia, citing information from the […]

The post 5,000 Pounds of pine nuts recalled due to possible Salmonella appeared first on Minor Topics.

          â€œBaddies” – Overview Of Unwanted Chemicals In Cosmetics        
by Dr. Irene Reyzis           “Baddies” – Overview Of Unwanted Chemicals In Cosmetics Can chemicals in cosmetics affect your health? You may be wondering, if a chemical is bad for your health, why would it be used in cosmetics? The FDA does not usually ban ingredients even if they are known […]
          A Guns-Drawn Office Raid        

Folks, remember Joe McCarthy in the 1950s? Well tyranny is back, only worse. We are in the midst of an ugly struggle for power by the FDA and those who support giving the FDA more power over the nutritional supplement industry. They are today’s crop of bureaucratic tyrants. Whereas Joe McCarthy’s witch hunt was based […]

The post A Guns-Drawn Office Raid appeared first on Dr. Whitaker's Freedom of Health Foundation.

          A 20th Century Book Burning        

In his book, Racketeering in Medicine, the Suppression of Alternatives, James P. Carter, MD, professor at Tulane University, writes, “The FDA serves as the pharmaceutical industry’s watchdog, which can be called upon to attack and destroy a potential competitor under the guise of protecting the public.” To this end, the FDA will even burn books and intended to […]

The post A 20th Century Book Burning appeared first on Dr. Whitaker's Freedom of Health Foundation.

          The Stevia Saga        

This is a Tale of Two Sweeteners, full of sound and fury, signifying that the FDA has sold you and your kids to the drug companies again, and you are unwitting receptacles of a sweetener that has obvious toxicity. The Dark Side of Aspartame If you drink diet sodas or add Equal or NutraSweet to your coffee, […]

The post The Stevia Saga appeared first on Dr. Whitaker's Freedom of Health Foundation.

          FDA Busted!        

An obvious source of information for healthcare consumers is nutritional supplement labels. Believe it or not, until recently, it’s been illegal for manufacturers to print consumer-friendly information on their products’ labels. The Food and Drug Administration (FDA) has suppressed virtually all scientific information on supplement labels that would explain how to use them to prevent […]

The post FDA Busted! appeared first on Dr. Whitaker's Freedom of Health Foundation.

          Comment on Vaccines, mercury and you by Mairi Morrison        
Merbromin is now banned in the USA, Germany & France, due to the mercury content - hardly a good example to support your claims, Luke, seems to me like you shot yourself in the foot there, mate. Another "own goal" is your false claim that infant vaccines do not contain thimerosal - they do. These include the DTaP vaccine, DT vaccine, Hib (ACTHib, TriHIBit) and Meningococcal vaccine - see more at: http://healthimpactnews.com/2014/dr-oz-warns-about-mercury-in-flu-shots/#sthash.FkGepSF1.dpuf Lastly, you appear to be ignorant of the FDA rule change, which allows vaccine-manufacturers to lie about the fact that their vaccines still contain thimerosal, The meningococcal vaccine given to children age two years and older contains the same amount of thimerosal (50 mcg.) as the multi-dose flu shots. - More at: http://healthimpactnews.com/2014/dr-oz-warns-about-mercury-in-flu-shots/#sthash.FkGepSF1.dpuf The FDA rule change means that Thimerosal used in the manufacture process of a vaccine DOES NOT need to be listed - even although the actual amount of Thimerosal in the final vaccine can exceed the amount present in vaccines that must honestly list this on the label - ie when used as a preservative, post-manufacture. Thimerosal contains almost 50% mercury. You remember Alice in Wonderland? The Mad Hatter? That's what happened to milliners (hat-makers) in the old days - they went nuts, due to the amount of mercury used in curing the felt pelts for the hats. Hence the phrase "as mad as a hatter" - which could accurately be used to describe yourself, as anyone who would recommend to others that willingly taking doses of the highly neuro-toxic element Mercury is good for them, has to either be mad, high, drunk, or deranged. Maybe you've just had too much mercury, Luke?
           FDA Announces New Draft Guidance on Use of Electronic Health Record Data in Clinical Investigations         

By George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law On May 17, 2016, the United States Food and Drug Administration (FDA) published a draft guidance titled “Use of Electronic Health Record Data in Clinical Investigations” (Draft Guidance) which emphasizes interoperability and outlines other best practices for effectively using EHR data in FDA-regulated studies. The Draft Guidance is intended to assist sponsors, clinical investigators, contract research organizations (CROs), institutional review boards, and other interested parties on the use of EHR data in FDA-regulated clinical investigations....

           FDA Issues Warnings About Research Participant Protections and Inadequate Sterilization of Medical Equipment to Mayo Clinic Care Network Hospital         

By George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law On April 12, 2016, the US Food and Drug Administration (FDA) issued warnings that targeted the allegedly substandard protection of research participants at a hospital in the Mayo Clinic Care Network. It also addressed shortcomings involving the sterilization of medical devices used to harvest fat during plastic surgery. Below are the enforcement actions taken by the FDA. Hospital Allegedly Fell Short on Protecting Human Research Participants....

           2015 Proved to Be a Good Year in Medicine as FDA Approvals of First-Of-A-Kind Drugs Continued to Escalate         

By George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law It's been 19 years since anyone has seen the approval of more first-of-a-kind drugs by the US Food and Drug Administration (FDA). 2015 proved to be a year of satisfactory innovation for medicine. With the approval of 45 drugs formulated with never-before-sold ingredients, the FDA came close to surpassing its previous all-time record of 53 first-of-a-kind drug approvals in 1996. The increase in newly formulated drugs is a reflection of the industry's shift in focus to a greater availability of treatments for rare and hard-to-treat diseases....

           Amarin Pharma, Inc., Wins Injunction Against FDA's Off-Label Marketing Ban         

By Michael L. Smith, R.R.T., J.D., Board Certified by The Florida Bar in Health Law The US District Court for the Southern District of New York granted a preliminary injunction to Amarin Pharma, Inc. (Amarin), prohibiting the Food and Drug Administration (FDA) from enforcing its off-label marketing ban. The injunction means that Amarin can engage in truthful marketing of Vascepa even when the marketing is used to promote an off-label use of Vascepa. FDA Ban on Off-Labeling Drugs. Off-label use of drugs is the prescribing of a drug for a purpose other than what has been approved by the FDA....

           U.S. Food and Drug Administration Finalizes Rule on Codes that Will Track Medical Devices         

By George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law On September 20, 2013, the US Food and Drug Administration (FDA) announced that companies will have to include unique device identification (UDI) codes on medical devices. These codes will provide a consistent way to identify medical devices, and therefore, should improve patient safety, according to the FDA. The codes allow regulators to track products, monitor them for safety and expedite recalls. The UDIs will be entered into a public database that the FDA will maintain. Click here to read the press release from the FDA ....

           Steroid Injections Compounded at Tennessee Pharmacy Recalled Due to Possible Contamination         

By George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law The US Food and Drug Administration (FDA) sent out a warning to health care professionals that steroid injections compounded by Main Street Family Pharmacy, LLC, in Tennessee, may be contaminated. The announcement came on May 24, 2013. So far, seven patients have allegedly suffered adverse reactions from the medications. The FDA says it is working with the Centers for Disease Control and Prevention (CDC) and the Tennessee Board of Pharmacy to investigate. The steroid injections were allegedly sent to 13 states, including Florida. To read the press release from the FDA, click here ....

           Food and Drug Administration (FDA) Recalls Sterile Drugs from Florida Compounding Pharmacy         

By Lance O. Leider, J.D., The Health Law Firm There’s been yet another recall from a compounding pharmacy. On May 8, 2013, the US Food and Drug Administration (FDA) sent a warning to doctors and pharmacists to avoid drugs made by The Compounding Shop, based in St. Petersburg, Florida. The recall is due to potential safety concerns. Click here to read the press release from the FDA . This recall is part of a nationwide crackdown by the FDA and state agencies on compounding pharmacies, setting off a number of recalls across the country. These agencies are trying to prevent another widespread outbreak, like the fungal meningitis outbreak in the fall of 2012....

           Florida Compounding Pharmacy Recalls Eye Products         

By George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law A Lake Mary, Florida, compounding pharmacy recently recalled products due to concerns from the Food and Drug Administration (FDA). The Balanced Solutions Compounding Pharmacy, LLC (Balanced Solutions), a division of Axium Healthcare Pharmacy Inc., announced a voluntary recall of all lots of its sterile unexpired ophthalmic products on April 17, 2013. Click here to read the press release from Balanced Solutions on the recall . This recall was issued as the FDA and state agencies step up regulation on compounding pharmacies across the country....

           Food and Drug Administration (FDA) Updates Safety Concerns on Metal-on-Metal Hip Implants After Two Wide-Spread Recalls         

By George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law and Carole C. Schriefer, R.N., J.D., The Health Law Firm On January 17, 2013, the Food and Drug Administration (FDA) issued an updated public health communication about hip replacement components that have both a metal ball and a metal socket, or metal-on-metal hip devices. This comes after two recent hip replacement recalls that are sparking thousands of lawsuits. Click here to read the FDA communication . In August 2010, Johnson and Johnson’s DePuy Orthopaedics implemented a DePuy ASR hip recall, withdrawing more than 93,000 hip implants from the market....

          fast weight lose and diet for diabetes        

First, you should consider the technical and mechanical aspects of choosing the right exercise regime and the right diet for yourself. In this writer's opinion, the best workout and meal-plan is the one that satisfies you, challenges you, and, more often than not, makes you glad that you are doing what you are doing. There are a few general guidelines that you should follow. In choosing a workout routine, try to do at least as much cardiovascular exercise as you do strength training. If you lift weights two times a week, go for a jog two days as well. When it comes to diet for diabetes, focus less on the type of food you are eating (it seems like the 'right food' changes weekly, anyway) and instead try to control the amount of food that you eat. This is a surprisingly difficult thing to do, but if you can cut down your meal size by just a small amount each day, after several (2-9) weeks you should be able to comfortably eat the FDA recommended caloric intake per day.

As a diabetic, you know that the challenges of life do not come with a 'satisfaction-guaranteed' sticker- there are some obstacles that take a lot of you, and there is rarely ever an expectation of complete success. But if you keep your eyes on the long-term goal of health success, you should be able to weather any setback that comes your way.

Any individual with diabetics interested in fast weight lose and keeping their body healthy should consider their task on multiple levels. Certainly, there is the technical and mechanical aspect of performing the correct exercises, eating the right foods, and training your body in the most beneficial and satisfying ways, but there is also the less considered aspect of mental preparation and sound spiritual framework.

There is a wide body of magazine and health journal literature that focuses on preparing an athlete or an individual for the rigors of a training regimen by seemingly trying to 'cure' them of the difficulties and the failures they will no doubt face, but this is not the right way to train. Any individual currently living with diabetes knows that there is more to life than simply succeeding and doing well. Like battling the disease itself, battling a workout routine and a new diet will be filled with achievements as well as failures and setbacks; the key is to continue moving forward. Ultimately, it is just your weight, but the success and self-confidence that you can earn through working out and eating right can be carried over to the rest of your life and into your fight against diabetes.
           Franck's Pharmacy Announces Compounding Prescriptions Recall, Shuts Down Sterile Compounding Service         

Beleaguered Franck's Pharmacy, Inc. located in Ocala, Florida, has issued a recall for its compounded prescriptions. The prescriptions impacted by this recall include all sterile human and veterinary compounded prescriptions distributed by Franck’s Pharmacy from November 21, 2011 to May 21, 2012. Franck's Pharmacy made the announcement on the company's website on May 24, 2012. To see the recall click here . Recall Based on FDA Findings of Fungal Growth in Pharmacy's Clean Room. The recall was apparently prompted by action by the US Food and Drug Administration (FDA)....

           Clinical Trial: When Research Goes Wrong         

Three patients died in an unapproved medical trial conducted between 2003 and 2004. Now, the executives of Snythes Inc., a medical-device company, are awaiting sentencing this week after pleading guilty to a misdemeanor as "responsible corporate officers," according to Business Week. The Synthes officials allegedly bypassed FDA protocol to have surgeons test bone cement in people with spine fractures. The product was not approved for that use, and three people died in the operating room in 2003 and 2004. The patients who died suffered a severe drop in blood pressure following the injections....

          Shareholder Notice: Update in Lawsuit Against Insulet Corporation (NASDAQ:PODD)        

A lawsuit is pending for investors in shares of Insulet Corporation (NASDAQ:PODD) over alleged securities laws biolations and NASDAQ:PODD investors should contact the Shareholders Foundation.

San Diego, CA -- (SBWIRE) -- 08/09/2017 -- A lawsuit is pending for certain purchasers of NASDAQ:PODD shares against Insulet Corporation over alleged Violations of Securities Laws.

Investors who purchased shares of Insulet Corporation (NASDAQ:PODD) in April 2013 or earlier and continue to hold any of those NASDAQ:PODD shares have certain options and should contact the Shareholders Foundation at mail@shareholdersfoundation.com or call 858-779-1554.

On May 6, 2013, Insulet Corporation announced the successful launch of its new Eros system, touting positive customer feedback, the transition of all new customers to the system and a resulting growth in both United States and overseas markets.

On January 7, 2015, Insulet disclosed that it was appointing six new executives from outside the company into key leadership positions and that its fourth quarter 2014 revenue would be $5 to $8 million less than the company's recent guidance due to reduced demand for Eros product from Insulet's distributors.

On April 30, 2015, Insulet Corporation revealed that revenues were much lower than forecasted, due in part to a myriad of issues with the Eros system.

On May 5, 2015, a lawsuit was filed against Insulet Corporation over alleged securities laws violations. The plaintiff alleged that the defendants allegedly failed to disclose that Insulet Corporation was experiencing slower demand for its products, that Insulet Corporation was facing issues with its sales and marketing efforts, that that, as a result, Insulet Corporation experienced unevenness in its financial performance, and that, as a result of the foregoing, Defendants' positive statements about Insulet's business, operations, and prospects lacked a reasonable basis.

On June 5, 2015, the U.S. FDA issued a letter to Insulet Corporation regarding defective lots of Eros that had been manufactured and shipped between 2013 and 2014 resulting in the Company recalling over 40,000 boxes of the product.

On June 1, 2016 an amended complaint was filed and on August 1, 2016 the defendants filed their motion to dismiss the case. On March 17, 2017, the Court denied the defendants' motion to dismiss the securities class action complaint.

Those who purchased shares of Insulet Corporation have certain options and should contact the Shareholders Foundation.

Shareholders Foundation, Inc.
Michael Daniels
3111 Camino Del Rio North - Suite 423
92108 San Diego
Phone: +1-(858)-779-1554
Fax: +1-(858)-605-5739

For more information on this press release visit: http://www.sbwire.com/press-releases/shareholder-notice-update-in-lawsuit-against-insulet-corporation-nasdaqpodd-845559.htm

Media Relations Contact

Michael Daniels
General Manager
Shareholders Foundation
Telephone: 858-779-1554
Email: Click to Email Michael Daniels
Web: http://www.ShareholdersFoundation.com

          Ð§ÐµÐ¼ украинцев лечат, а чем – калечат        
Государственные органы то и дело нас пугают вспышками различных эпидемий – разными вирусами гриппа в осенне-зимний период, а летом приходится опасаться ботулизма или отравлений. Однако забывают сказать о постоянно преследующей украинцев эпидемии - мы говорим об эпидемии назначений "фуфломицинов" - то есть лекарств, которые не способны вылечить.

О том, как распознать "пустышку", а также о том, почему нам все это назначают, рассказывает сегодня "Обозреватель. МедОбоз".

Чем опасны такие "лекарства"?

Не первый раз в ведущих СМИ поднимается тема назначений врачами неэффективных лекарств, однако за словами не следуют действия чиновников от медицины. А ведь мы платим им зарплаты, чтобы они эффективно нас лечили и защищали нас, а не фарминдустрию.

Решить задачу просто – ведь с подобными проблемами уже сталкивались все страны мира, и в цивилизованных странах давно научились с ней справляться. Украинцам не придется изобретать колесо - все, что для этого нужно, это политическая воля. А рецепт от фуфломицинов давно известен.

Поскольку сроки ожидания решения этой проблемы на государственном уровне туманны, предлагаем научиться самим разбираться – какие из фармпрепаратов обладают доказанной эффективностью, а какие - нет.

Сразу оговоримся – мы не будем рассказывать, как вам лечиться самостоятельно. Мы вам расскажем, какие вопросы нужно задавать врачам, чтобы избежать назначения пустышки для лечения болезни. Вы теряете на этом время и деньги. Ведь часто врач, ясно осознавая, что назначает ерунду, выписывает сразу 5-6, а то и 10 препаратов. И требует пропить их ВСЕ. Другими словами, он страхует себя от риска запустить болезнь, и в то же время отрабатывает заказ от представителя фармкомпании.

Как следствие, бывает и так, что пациент вылечивается, принимая 2-3 эффективных, и одновременно – 2-3 неэффективных препарата.

Что же в этом особенного, спросите вы, - ведь болезнь отступит, так что страшного, если пропить попутно дополнительные лекарства?

В чем опасность приема таких препаратов:
- они не лечат;

- они имеют серьезные побочные эффекты;

- вы тратите на них средства, которые могли бы потратить на действительно эффективные препараты.

По-настоящему эффективное лекарство: как создается и почему такое дорогое

Для понимания того, в чем разница между эффективными и неэффективными лекарствами, немного расскажем о том, как создаются лекарства.

Новые лекарства создают двумя способами:

- берут уже известное вещество, и "методом научного тыка" узнают, какую очередную болезнь оно может вылечить;

- изобретают (искусственно синтезируют) новое вещество, которое лечит конкретную болезнь.

Большинство современных лекарств делается по второму пути. Хотя известны случаи, когда давно известный активный ингредиент проявляет свою эффективность по отношению к болезни.

Что такое – мишень для лекарственного вещества

Вначале в фармкомпании изучают спрос, объем рынка, его потенциальный рост. Затем ученые исследуют имеющуюся информацию о заболеваниях и начинают поиск биологических клеток-мишеней, воздействие на которые позволит влиять на заболевания.

В США и Евросоюзе на сегодня утверждены 1400 действующих веществ. Однако они взаимодействуют лишь с 324 клетками-мишенями.

Если активное вещество не имеет способности воздействовать на мишень, и препарат также не имеет механизма воздействия на организм с тем, чтобы в результате обменных процессов это воздействие произошло – его эффективность подлежит сомнению.

Как разрабатывают новые лекарства?

Весь цикл от старта разработки и до регистрации может занять 8-10 лет. Первым делом для поиска вещества используются особые банки химических веществ. Их тестируют с помощью компьютерного моделирования. Затем особо перспективные молекулы проверяют на особых биохимических и клеточных моделях.

После определения молекул, которые должны влиять на мишени, их тестируют на животных – это так называемые доклинические исследования. Животные тоже не простые, а генно модифицированные. Например, для тестирования лекарства от муковисцидоза ученые создали и вырастили специальных генно модифицированных свиней, а для лечения гипертонии – крыс-гипертоников.

После чего ученые переходят к самому ответственному этапу - испытаниям на людях, или к клиническим исследованиям, которые состоят из трех фаз:

- первая проводится на небольшой группе здоровых пациентов, за денежное вознаграждение;

- вторая проводится на большей группе больных пациентов (несколько сотен человек - бесплатно);

- третья проводится на группе в несколько тысяч больных пациентов - бесплатно.

Подобные испытания проводят во многих странах. Например, в США в прошлом году провели более 8160 клинических исследований, в Польше - 359, а в Украине – лишь 200.

Исследования проводят в соответствии с жесткими стандартами, выработанными с годами путем проб и ошибок. Например, известна трагедия, следствием которой стало 107 погибших в США из-за того, что при лечении стрептококка к препарату Elixir sulfanilamide был добавлен диэтиленгликоль. А 1961 год был отмечен талидомидовой трагедией, следствием которой стало рождение более 10 тысяч детей, имеющих уродства конечностей. Врачи тогда ошиблись, посчитав, что плацента матери обеспечивает защиту ребенка от воздействия химических веществ.

Каждая из таких ситуаций вызывала ужесточение и постоянное совершенствование требований регуляторных органов к безопасности и эффективности лекарственных средств.

Если все три фазы исследований прошли успешно, то производитель подает документы в регуляторный орган для регистрации. В США этим занимается FDA (Food and Drug Administration), в странах Евросоюза – EMA (European Medicines Agency), а в Украине - Государственный экспертный центр Минздрава Украины (ГЭЦ).

По данным за 2016 год, бюджет фармпроизводителей в мире достиг $154 млрд. Благодаря таким расходам каждый год только FDA и EMA регистрируют до 50 новых лекарств, причем каждое из них стоило разработать более $2 млрд. Поэтому производитель получает право патентной защиты на 10-20 лет, когда никто не имеет права делать с них копии (генерики, или как их еще называют - аналоги).

За это время производитель зарабатывает на препарате, "отбивая" вложенные средства. А уж потом его разрешено копировать любому предприятию. Все, что для этого требуется – хорошая лаборатория и несколько недель работы. И вот уже копия готова, лекарство поступает в продажу по цене в 10 раз дешевле.

Как видим, на создание эффективного инновационного лекарства уходят годы труда и миллиарды средств.

Как же обстоит дело с проверкой на эффективность лекарств в Украине?

Для регистрации лекарства в Украине пакет документов – регистрационное досье – подается на экспертизу в упомянутый ГЭЦ. Если все прошло успешно, производитель получает регистрационное удостоверение на лекарство. В числе прочего в досье содержится подтверждение эффективности и безопасности препарата. Однако для публики эта информация закрыта, так как является коммерческой тайной. Как следствие, мы никогда не сможем узнать, чем руководствовались чиновники при выдаче разрешения.

Однако, хотя с годами в Украине ужесточаются требования к новых препаратам, у нас все еще зарегистрировано огромное количество веществ, которые не смогли пройти регистрацию ни в FDA, ни в EMA. Но, если сильно поискать, их можно найти в аптеках ЕС или США в качестве БАДов.

При этом более трети из 30 самых продаваемых в Украине лекарств вообще не продают ни в США, ни в одной стране ЕС.

У этой странности может быть два объяснения - или мы умнее американцев и европейцев, или мы попросту выбрасываем на ветер деньги, покупая фуфломицины.

Объем украинского фармрынка – около 50 млрд грн. По утверждениям экспертов, треть из них – неэффективны или, по крайней мере, имеют сомнительную эффективность. То есть, другими словами, почти 17 млрд гривен украинцы платят за то, чтобы получить побочные эффекты, но не получить эффективного лечения.

В чем секрет популярности неэффективных лекарств?

В первую очередь это – реклама. И речь идет не только о телевидении и других СМИ, хотя на них тратятся миллиардные бюджеты. Сотни, если не тысячи медицинских представителей фармкомпаний обивают пороги поликлиник, уговаривая – разумеется, за материальное вознаграждение (ретробонус) - назначать пациентам их, и только их препараты. Учитывая мизерные зарплаты и практически отсутствие ответственности за результат лечения, украинские врачи охотно идут им навстречу.

Второй важной причиной назначения фуфломицинов является низкий уровень медицинского образования отечественных медработников. Англоязычную литературу они читать не способны, а отечественная обычно носит откровенно рекламный характер и издана фармацевтическими компаниями, или медицинскими издательствами, но на деньги фармацевтических компаний.

Третьей причиной, являющейся следствием первых двух является повальное самолечение украинцев. Причем в этом им помогают:

- интернет, полный липовых советов все тех же фармпредставителей;

- аптекари, цель которых – продать побольше препаратов. И чем менее будет эффективным очередное лекарство, тем лучше аптекÐ
          Fads and Faith: Belief vs. Fact in the Struggle for Health        

In 2014 the United States had 650 reported cases of measles, a disease made preventable by a vaccine introduced 30 years ago. The majority of these measles victims were children whose parents chose not to vaccinate them.  Meanwhile at least 85,000 dietary supplements line the shelves of GNC and other “big box” chains, as well as smaller health food stores. Even though the FDA cannot assure the safety or effectiveness of any of these products before they're sold, they enjoy widespread popularity in the United States. This episode of Distillations explores what connects these two issues.

Our journey starts in Shanghai, where reporter Rebecca Kanthor investigates a strange fashion trend among pregnant women—a special apron meant to protect its wearers from the harms of electromagnetic radiation.

Then we talk with Paul Offit, an infectious disease pediatrician at Children’s Hospital of Philadelphia and author of Bad Faith: When Religious Belief Undermines Modern Medicine, and Catherine Price, author of Vitamania: Our Obsessive Quest for Nutritional Perfection,about what drives these fads. Our guests suggest that faith, a desire for easy answers, and a lack of trust in medical science all come into play.


00:03 Introduction

01:40 Pregnancy Aprons in Shanghai

11:33 Interview with Catherine Price and Paul Offit


Hosts: Michal Meyer and Bob Kenworthy

Guests: Catherine Price and Paul Offit

Reporter: Rebecca Kanthor

Producer & Editor: Mariel Carr

Music courtesy of the Audio Network.


Check out Distillations magazine at distillations.org, where you'll find articles, videos, and our podcast.

          Seminar: Software as a Medical Device        
Seminar: Software as a Medical Device:
Safety and security. 
January 5, 9-11 am 

Teaduspargi 6/1, Tallinm, Estonia
Seminar room: Merkuur 

Connected Health cluster presents a practical seminar to help health IT developers and startups plan and manage smoothly their products to comply with needed standards and rules.

9:00 What is a software as a medical device and what is required to get regulatory compliant products on the market - overview of medical device software safety, regulations in EU and US, standards and FDA guidance - Dr. Marion Lepmets, Co-Founder & CEO of SoftComply – 30 min presentation + 15 min Q&A

9:45 Privacy Engineering and Health Data: IT and IoT - Dr. Ian Oliver, Security Specialist at Bell Labs – 30 min presentation + 15 min Q&A

10:30 Discussion and 1-2-1 Q&A

Please register by January 3 the latest: services@tehnopol.ee 

Free for Science Park Tehnopol network and service clients and Connected Health cluster members. 30€ + vat for others.
          Do Drug Reps Have Free-Speech Rights to Share Shoddy Studies?        

Pharma has landed a double blow against the American government. The U.S. Court of Appeals in New York has ruled that a drug salesman was exercising his right to free speech by pitching a narcolepsy drug as effective against insomnia, chronic fatigue and other conditions the Food and Drug Administration had not approved. If the Supreme Court upholds this decision, companies will pay fewer multi-billion dollar fines and useless healthcare spending will increase.

Regulators argued that the pitch showed the salesman was illegally selling a misbranded drug. But the court said he had a free-speech right to give doctors truthful information so they could legally prescribe the medicine. The regulator violated that right, the judges ruled, by barring his off-label recommendations.

The decision applies only in three states, but the FDA is likely to appeal. That could put the case before the Supreme Court and make this victory for the pharmaceutical industry a national precedent. GlaxoSmithKline, for instance, shelled out $3 billion in July to settle three indictments, two of which were off-label marketing of antidepressants and other drugs. In the past four years Pfizer, Johnson & Johnson, Abbottand Eli Lilly have each paid, or are negotiating to pay, settlements over $1 billion.

It’s not just missing these regular injections of cash that will cause the government pain. It will also increase medical spending. That’s because pharma reps will be allowed to discuss studies of drugs that the FDA has not vetted. Unfortunately, some studies are shoddy and clinical trials cherry-picked by sales staff. This encourages doctors to prescribe extremely costly drugs, which can have little benefit, to patients.

In the GSK settlement, for example, the company allegedly participated in preparing, publishing and promoting a journal article that misleadingly asserted its drug Paxil was effective in treating depression in minors. Other studies showed the drug didn’t work in teens, with some demonstrating that antidepressants like Paxil may increase suicide risk.

The industry has engaged in such behavior because it is financially appealing. The ruling increases the temptation, which is likely to pile more costs onto Medicare and Medicaid, which spent $86 billion on branded pharmaceuticals in 2010. With Medicare already accounting for about 4 percent of GDP, that’s bad news for the nation’s financial health.

Read more at Reuters Breakingviews

          Handy Tips: Green Living         

Martha Stewart queen of home and living, has inspired me to collate a list for all our elaundry lovers, how to go green, save energy and money!

Bring Back Cloth Napkins
On average, each American uses a staggering 2,200 paper napkins a year, none of which are recycled. Yes this is an American figure however we are just as guilty of using paper napkins to fix spills and have for your dinner guests than Americans. So in turn why not reduce waste (and deforestation) by choosing cloth instead? I know where you can find some great cloth napkins and even better enjoy customization with embroidery! You might even boost your mindful eating quotient: It's much easier to linger over dinner with the table set the old-fashioned way.

Try Reusable Towels
Paper towels cause waste yep 2012 doesn't get any easier waste and consumption are our two main offenders -- even if you stick to the recycled brands. Microfiber towels grip dirt and dust like a magnet and don't let go. After use, toss the towels into the laundry and reuse over and over. Mind the
There are a few simple guidelines to follow to make microwave use safer and energy efficient, including avoiding certain plastics when reheating obviously you already know this! Use the microwave infrequently, if at all. Microwave ovens do leak radiation, but at very low levels that the FDA and most scientists believe are harmless.

Eco Shopping Bag
Take a recycled pillowcase bag to the store or farmers' market and cut down on plastic usage! It will surprise you how little plastics will build up in your household!  

          16 ridiculous 'facts' about animals you should really stop repeating        

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Who hasn't shared an amazing science fact about sharks, cats, bats, ostriches, or other animals, only to feel embarrassed later on when you find out the information was wrong?

No more.

It's time to put an end to these myths, misconceptions, and inaccuracies about animals passed down through the ages.

To help the cause we've rounded up and corrected dozens of the more popular myths we keep hearing repeated.

Have any favorites we missed? Send them to science@techinsider.io.

Kevin Loria, Lauren Friedman, Kelly Dickerson, Jennifer Welsh, and Sarah Kramer contributed to this post. Robert Ferris contributed to a previous version.

MORE: A photographer swam with sharks for 10 years to capture these stunning photos

UP NEXT: Researchers have accomplished something that has never been done before, and it’s bringing us one step closer to nuclear fusion power

MYTH: There are bugs in your strawberry Frappuccino.

This one is no longer true.

Before April 2012, Starbucks' strawberry Frappucino contained a dye made from the ground-up bodies of thousands of tiny insects, called cochineal bugs (or Dactylopius coccus).

Farmers in South and Central America make a living harvesting — and smashing — the bugs that go into the dye. Their crushed bodies produce a deep red ink that is used as a natural food coloring, which was "called cochineal" red but is now called "carmine color."

Starbucks stopped using carmine color in their strawberry Frappucinos in 2012. But the dye is still used in thousands of other food products — from Nerds candies to grapefruit juice. Not to mention cosmetics, like lovely shades of red lipstick.

Sources: Business Insider, CHR Hansen, AmericanSweets.co.uk, FoodFacts.com, LA Times

MYTH: Beaver butt secretions are in your vanilla ice cream.

You've probably heard that a secretion called castoreum, isolated from the anal gland of a beaver, is used in flavorings and perfumes.

But castoreum is so expensive, at up to $70 per pound of anal gland (the cost to humanely milk castoreum from a beaver is likely even higher), that it's unlikely to show up in anything you eat.

In 2011, the Vegetarian Resource Group wrote to five major companies that produce vanilla flavoring and asked if they use castoreum. The answer: According to the Federal Code of Regulations, they can't. (The FDA highly regulates what goes into vanilla flavoring and extracts.)

It's equally unlikely you'll find castoreum in mass-marketed goods, either.

Sources: Business Insider, Vegetarian Resource Group, FDA, NY Trappers Forum

MYTH: Dogs and cats are colorblind.

Dogs and cats have much better color vision than we thought.

Both dogs and cats can see in blue and green, and they also have more rods — the light-sensing cells in the eye — than humans do, so they can see better in low-light situations.

This myth probably comes about because each animal sees colors differently than humans.

Reds and pinks may appear more green to cats, while purple may look like another shade of blue. Dogs, meanwhile, have fewer cones — the color-sensing cells in the eye — so scientists estimated that their color vision is only about 1/7th as vibrant as ours.

Sources: Today I Found Out, Business Insider

See the rest of the story at Business Insider
          FDA daje zielone światło dla niwolumabu        
Amerykańska Agencja ds. Bezpieczeństwa Żywności i Leków (FDA) zarejestrowała niwolumab w terapii pacjentów z klasycznym chłoniakiem Hodgkina (cHL) - informuje w komunikacie prasowym firma Bristol-Myers Squibb.
          The FDA and 23andMe        

First, download your 23andMe raw results now if you have them. If you don’t know what’s going on, the FDA has finally started to move aggressively against the firm. Unfortunately this is not surprising, as this was foreshadowed years ago. And, 23andMe has been moving aggressively to emphasize its medical, as opposed to genealogical, services […]

The post The FDA and 23andMe appeared first on Gene Expression.

          The VLCC Coolsculpt! #VLCCStyleStatements        
Ri(t)ch Styles VLCC Coolsculpt Weight Loss Fat Loss

A woman goes through a lot in her life, be it pregnancy or hormonal changes with changing age, that make us put on weight. Due to the constant pressure of being on top of things at home and office, we are more than often left with no time for ourselves, especially during those years when you have a baby or small child at home. Sadly, exercise and hitting the gym is not a privilege a lot of us get and eventually the fat cells stay in our body and we develop bulging tummies and love-handles that don't look good at all. Becoming a mommy is one of the busiest jobs in the world as you are constantly running behind the kids to feed them, clean them, play with them and help them learn new stuff. Before Aryaa was born I would regularly go to the gym to be in shape, but after her birth, my days are spent in working and spending time with her and I am left with no time to go to the gym. I did join martial arts classes a few months back, but couldn't continue going to the class because of time constraints.

Now that I am heading to the US for a vacation, I want to lose some weight because no one comes back from the US without weight gain, and I cannot afford to add anymore to my already increased weight! Since I have to finish my work commitments before I head for my vacation, my schedules are going to be super busy and as always, I am not going to have time to go the gym. Hence a few days ago I started finding out other safe options that would work for me since there are so many these days, and came across this really cool concept by VLCC called the VLCC Coolsculpt. Coolsculpting is a non-surgical way to reduce excess fat from the body without harming or damaging other cells or tissues. Confused when I say non-surgical way to reduce fat? Believe me, it's not impossible, and I am going to tell you all about it.

Coolsculpting uses a patented ultra-low temperature spot cooling process called Cryolipolysis which targets the excess fat areas of the body and freezes the fat in those particular areas. There is a special type of white blood cells in our body called Macrophages which digest and consume these crystallized fat cells, and the debris of the same are slowly cleared through the lymphatic system which leads to a permanent reduction of the fat cells of up to 25% from the treated areas. What made me zero down on this concept was that in traditional weight-loss programs, the size of the fat cells reduce but their number doesn't change, while via Coolsculpting the number of cells itself reduce. For this treatment, a special combination gel and film is used so as to protect the skin from damage caused by low temperatures. Each part of the body is treated with a different applicator depending on the shape of the body part to be treated, so that the result is optimum.

This VLCC Coolsculpt treatment is FDA approved. One sitting of the treatment can start showing results within two weeks and within three months you will be back in shape. No change in the lifestyle, no crash diets, no worries of taking artificial supplements - getting back into shape becomes a breeze with the help of this treatment that also has no side effects. ðŸ˜Š

If you like what you see on Ri(t)ch Styles and want to stay updated regularly, follow Ri(t)ch Styles on

Ri(t)ch Styles YouTube

You can also email me on ritchstyles@gmail.com :)

          update on me        

A couple weeks ago I had a pretty nasty cold it was also right after we found out the Elliott had MRSA. I took that week, two weeks ago, off work thinking if I rested up from the cold which was kicking my butt and did the right things it would be 'just' a cold. I also figured that would give me the time to find E a new home and get our house decontaminated from MRSA which was an undertaking, the washing of stuff at the Laundromat alone cost almost $50.

I went to the doctor that week for my lungs as well which was a normally scheduled visit. My lung function was down a bit but at that point it was still just a cold and we agreed to watch and wait. I started to feel better on Sunday and was more than a bit tired of ‘taking it easy’ so I decided to be busy and productive, tell my body to get over it and all was pretty good; I was looking forward to returning to work on Monday. My body had other plans I woke up about midnight with severe lung pain on both sides, after some ibuprofen failed to work I woke Jared and asked for a vicodin that I have for lung pain then I decided to go to the ER as the vicodin wasn’t working either.

The ER was a futile trip spent in pain during all the hours of waiting while listening to the drug addict next door yell about he was in fact sober and they should let go of him and let him get back to the mission…fun times, I’d never been so glad for my kindle. Everyone seemed to think either I was having chest pain or back pain, no one seemed to accept that I was having pain from my lungs radiating down part of my back and into my chest….try explaining that when you can’t take a real breathe. I have to admit hours later when the doctor finally came in and told me it was a virus that just needed to run it’s course and I should just continue doing all my normal treatments I completely lost my cool and chewed him out telling him if I could breathe enough to do a breathing treatment I wouldn’t be here in the first place. In the end I said I’d follow up with my doctors and wanted to leave and apologized for being short. He said that he would give me something for the pain and send me home with instructions I could take two vicodin next time and then had the nurse give me so much dilaudid I was loopey the good thing was it stopped my coughing which also served to reduce the pain; I could tell as soon as it took effect as I could draw a breathe without pain.

The next day once I woke up I called my doctors who decided to start me on IV’s which arrived the next day. I was to do on inhaled antibiotic and IV zosyn which I have been on many times over the past about 5 years. The drugs in my lungs are pretty resistant to many antibiotics and zosyn seems to be the one stronghold that really works. I started my IV that night so it did one IV then and one during the night while I was sleeping and then I slept through while it was infusing my early morning one, 3 doses in total. Imagine my surprise when I woke covered in blotchy hives. Zosyn is a member of the cephalosporin family and it looks like I’ve developed a sensitivity to them. This was obviously a big blow to me since I had to stop the antibiotics and then they weren’t really sure on what they wanted to do since it appears that most of the drugs the bugs in my lungs are not resistant to also just happen to be part of the cephalosporin family. It took a day or so and then I started levaquin which is a strong oral antibiotic, initially I protested because it doesn’t normally work for me and the doctor had already passed over it in favor of IVs. I have what they call “intermediate” to that drug meaning basically it works but not as well as it should. Since our options were limited my normal doctor confirmed that was the best course but at a higher dosase and in continuance with the twice as strong inhaled antibiotics I was still doing.

The good news is that this combo seems to be working. Honestly I believe it is the inhaled antibiotic doing a good portion of the work since it started improving before the levaquin but with the type of bugs we CF’ers have in our lungs you never want to treat with only one antibiotic since that allows them to more easily build a resistance.

What one drug reaction wasn’t enough? Ok number two has intensified over the past week or so on the oral antibiotics and I am not scheduled to finish until Friday. I have previously been told I have plantar fasciitis in my right foot now it has intensified greatly and the left foot has started in. The bottoms of both feet have a swollen red nodule present just past my heel that persists despite icing and ibuprofen popping. According to Dr. Google it seems I may have really aggravated the fasciitis or partially torn it…fun. Levaquin has a black box warning from the FDA about tendonitis and tendon rupture but I am pretty certain it is responsible for this recent turn of events. I’m going to give my foot doctor a call on Monday to see if he can get me in. Unfortunately the tendon on my left wrist and foot are also hurting, I’ve had a bad bought tendinitis in my wrist before so I’m pulling out the wrist guards for sleeping to hopefully keep it from getting worse.

So let’s see, cold, MRSA scare, lung infection, hives, and now I’m hobbling like an old woman….ah these are the times of CF.

The good thing is that even if I have to stop the levaquin my lungs don’t feel in too bad of shape. I may be able to stop orals and start a second inhaled antibiotic, that will make for a lot of nebulizer times but if it lets me walk again and breathe easy it will be worth it. Better news is that the MRSA scare was just that, so far, a scare I have not tested positive for MRSA in my nose or my lungs *claps*. Also awesome news is that E is doing wonderfully as the only child in a first time foster family who are thrilled to have him are supporting reunification but also hoping to adopt some day. 

          What is Aqualyx and How Does it Work?        
Deoxycolic Acid is a molecule that naturally occurs in our bodies, helping us to break down and absorb fat in our diet. This is the active ingredient in Aqualyx, an injectable solution capable of dissolving fat in stubborn areas that seem to be resistant to exercise and diet. It is also the same element found in Kybella, a similar fat dissolver, which is used here in the United States. In fact, Aqualyx is only used in the U.K. and Europe, as the FDA hasn’t approved it for use in the U.S. So how do these fat melting injections work. This post gives a more scientific rundown of the process: Aqualyx – Illuminate Skin Clinics | Illuminate Skin Clinics The Aqualyx molecule attaches itself to the membrane of fat cells in the area of injection, and starts to dissolve the membrane surrounding the cell. This causes the fat cell to become unstable and to break open. The fatty acids contained within the cell are then eliminated by macrophages (part of the body’s immune system). The fat is ultimately eliminated from the body by the liver. Read more here:  Aqualyx – Illuminate Skin Clinics | Illuminate Skin Clinics Even though it is considered a minimally invasive procedure, there is some pain and swelling involved. However, it is nothing like the recovery time of having liposuction. The key is that the patient continues to massage the area several times a day for approximately five minutes a time, as this helps the fat to dissolve quicker. Mild swelling can last for up to two weeks, but most patients are able to return to work right away. This cosmetic surgeon from London provides more details about the injectable solution, answering the question – what is Aqualyx and how does it work: Aqualyx has been approved in many areas of the world as a safe way to dissolve smaller pockets of fat, such as under the chin but has also been used on other areas like the stomach, hips, and thighs. It usually takes at least two treatments to show good results, and sometimes up to eight return visits are required. Because of this, the cost is always a question on everyone’s mind. Compared to an all-out surgical procedure, such as liposuction, the cost is more affordable and you don’t have to go under anesthesia to have it done. Although, if you have to have the treatment done repeatedly, it can still get rather pricey. The next post gives an idea of what to expect with the cost: Aqualyx Review – Can A Sugar-Based Substance Be Helpful As Weight Loss Shots? The first concern we have is the Aqualyx price. According to our Research Editor, “The actual cost of these fat-loss injections is $600 to $700 per treatment, which is unaffordable for many people.” Read the original post here: Aqualyx Review – Can A Sugar-Based Substance Be Helpful As Weight Loss Shots? So, if liposuction costs between $2,000 to $8,000 depending on the area you are having worked on, it is probably still more cost effective to do an injectable, especially if you consider the recovery time. On the other hand, if you have to keep coming back numerous times for more injections, eventually you might want to weigh the pros and cons. Always consult with a reputable cosmetic surgeon about what is the best solution for you.    
          michael_vassar3 on Recursive Self-Improvement        

Phil: Anthropic pressures should by default be expected to be spread uniformly through our evolutionary history accelerating the evolutionary and pre-evolutionary record of events leading to us rather than merely accelerating the last stretch.

Exponential inputs into computer chip manufacture seem to produce exponential returns with a doubling time significantly less than that for the inputs, implying increasing returns per unit input, at least if one measures in terms of feature number. Obviously returns are exponentially diminishing if one measures in time to finish some particular calculation. Returns will more interestingly be diminishing per unit labor in terms of hardware design effor per unit of depth to which a NP and exponential complexity class problems can be calculated, e.g. the number of moves ahead a chess program can look. OTOH, it bizarrely appears to be the case that over a large range of chess ranks, human players seem to gain effective chess skill measured by chess rank with roughly linear training while chess programs gain it via exponential speed-up.

Society seems to in aggregate get constant zero returns on efforts to cure cancer, though one can't rule out exponential returns starting from zero. OTOH, this seems consistent with the general inefficacy of medicine in aggregate as shown by the Rand study, which doesn't overturn the individual impacts, as shown by FDA testing, of many individual medical procedures. Life expectancy in the US has grown linearly while GDP per capita has grown exponentially, but among nations in the modern world life expectancy clearly has a different relationship to income, not linear, not logarithmic, more plausibly asymptotic moving towards something in the early 80s.

I'm glad that you consider the claim about turning object level knowledge metacognitive to be the most important and controvercial claim. This seems like a much more substantial and precise criticism of Eliezer's position than anything Robin has made so far. It would be very interesting to see you and Eliezer discuss evidence for or against sufficient negative feedback mechanisms, Eliezer's "just the right law of diminishing retunrs" existing.

          A Mysterious Anonymous Letter Was Allegedly Behind Target’s Hampton Creek Recall        

The envelope of a letter sent to a retailer this summer, containing allegations about Hampton Creek's products. The return address names Josh Tetrick, Hampton Creek's CEO; the company says he did not write this letter.

An investigator hired by Hampton Creek, the Silicon Valley food startup famous for its eggless mayonnaise, says a mysterious entity appears to be trying to sabotage it.

An unsigned letter sent this summer to an unnamed major retailer claimed that Hampton Creek had contaminated and mislabeled products, according to the investigator. And the return address indicated that it was from CEO Josh Tetrick — even though Hampton Creek denies he wrote it.

The investigator told BuzzFeed News this was one of two known such anonymous letters — and the other was sent to Target, which issued a high-profile recall of Hampton Creek’s products as a result.

While it’s unclear whether the two letters were identical or sent by the same person, the identity of the sender or senders is “the million-dollar question,” said the investigator, who requested anonymity. “It’s clearly fraud.” He also said that Hampton Creek is “weighing their legal options.”

At the time of its recall in late June, Target publicly said that the allegations it had received were unconfirmed, but specific and serious enough to warrant action.

Those claims included allegations that pathogens like salmonella and listeria were found in Hampton Creek products and at one of the facilities where the company’s products are made; that some products were incorrectly labeled as non-genetically modified; and that the company failed to list honey as an ingredient in its sweet mustard salad dressing.

Bryan Bedder / Getty Images

This week, Hampton Creek said it’s working to get back on Target’s shelves after the Food and Drug Administration reviewed its products and told the company it found nothing of concern. Target had carried around 20 of Hampton Creek’s items, which include eggless mayonnaise, cookies, cookie dough, and salad dressing.

“More than a month ago, Target was led to believe that several of our products were mislabeled or unsafe,” Hampton Creek spokesperson Andrew Noyes said in a statement. “We’ve remained confident that our products were safe and properly labeled, and that when presented with the facts, the FDA would agree. As expected, they have. They informed us, after reviewing applicable evidence, that the matter is closed.”

A Target spokesperson did not immediately return a request for comment.

News of the Target recall was originally broken by Bloomberg. The investigator said that in addition to being mailed in an envelope with a return label that falsely named Tetrick, the letter also indicated that a copy was sent to Bloomberg.

This is the latest twist in a tumultuous summer for Hampton Creek. Last month, Bloomberg reported that at least five members have left the startup’s board of directors, leaving only Tetrick.

But on Tuesday, Hampton Creek also got the effective green light from the FDA to use a proprietary ingredient — a mung bean protein isolate — in a forthcoming product, Just Scramble, an egg substitute that scrambles like an egg.

LINK: Hampton Creek Has Ditched Its Name, And Is Now "Just."


Herzliya Medical Center, the leading private hospital in Israel is honored to introduce the newly renovated, state of the art and advanced Catheterization center. The best team of medical experts await to care, assist and provide for you, in your time of need.

Catheterization â€“ the procedure

Catheterization is a diagnostic procedure that aids in detecting and negating sclerotic processes in blood and cardiac vessels, while eliminating existing blockage. A tiny catheter is inserted and contrast material is injected.

The physician, medical staff and x-ray technicians are able to observe and monitor continuous x-ray, actual imaging, allowing for the detection of blood vessel blockage. once obstruction is determined the relevant treatment plan is implemented.

The Catheterization process allows for actual diagnostic and relevant immediate treatment.

Above all, the priorities of the doctors and the entire medical staff are the health and well-being of the patient and promoting and improving life-quality.

A personalized treatment plan is applied, based on medical history and personal information (age, gender) for each individual patient, together with diagnostic, technical applications.

During the procedure the medical team applies physiological measurements, "FFR" – Fractional Flow Reserve management, which monitoring arterial blood flow.

In comparison to other hospitals at Herzliya Medical Center, Catheterization are performed on a regular basis and are aimed on personalizing our unique treatment plan.

Conservative treatment

The most common conservative treatments for lowering risk factors are medications, to regular healthy cholesterol and blood pressure levels, as well as, a healthier diet and exercise strategy.

Therapeutic heart catheterization

If there is significant narrowing of the arteries observed, it may be found necessary to insert a balloon and a stent that secrete the most up to date medications, helping to preserve normal blood flow.

Diagnosis – surgical intervention

There are cases that reveal the need for by-pass surgery, due to significant blockage of the blood vessels. In this situation, depending on urgency, the patient is transferred to the heart institute and will be treated by one of the leading cardiac surgeons in the country, of his own choice.

The importance of choosing the correct Catheterization theatre

Catheterization is a safe conventional procedure that has been performed for decades on countless patients.

Herzliya medical center has recently acquired a state of the art "continuous monitoring x-ray imagine device” that allows for actual on-line display of the patients’ blood vessels. These on-line x-rays views, that are displayed on large screens in the cauterization theatre at all times, accompanied by a small amount of contrast material that is injected, allowing for the doctor and medical staff to view on a constant basis, blood flow in large areas of the body simultaneously and to perform the necessary treatment with optimum technique and precision.

This newly designed theatre, together with cutting-edge technology is the sole Catheterization center in Israel that has sufficiently reduced the radiation intensively by 70%.

The three main instruments used during the Catheterization procedure:

  1. Catheter – a flexible hollow tube employed to distend body passages for diagnostic examination, inserted and contrast material is injected.
  2. Balloon – a medical balloon is inserted to the blood vessels when necessary to distend the width of the artery.
  3. Stent – a coil, available in numerous sizes inserted into the vessel walls for support and allowing and conserving free flowing. There a many kinds of stents, always in stock and the patient has the option to choose stents that are absorbed by the body. All of the stents available at HMC are the most advanced and FDA approved.

Catheterization - a common procedure and the importance of the specific doctor who performs the process

It is true that this is a common procedure and years of experience is crucial to make the difference, especially in regard to invasive procedures. Here at HMC, our doctors the most experienced expertise medical professional are here for you. The medical team and x-ray technicians are able to observe and monitor continuous x-ray imaging at all times, allowing for the detection of blood vessel blockage. once obstruction is determined, the relevant treatment plan is implemented.

As a patient in our private hospital you are entitled to determine the doctor of your choice. We are obligated and honor your decisions and the doctor named will accompany you through all stages of your treatment plan.

We commit that all of our doctors will have senior status, with years of experience, guaranteeing you "peace of mind".

Safety and quality

The HMC Catheterization theatre is unique in Israel, recently designed as a most modern center with maximum safety measures employed. The center is hermetically sealed to guarantee the utmost sterility while the patient receives high quality treatment and privacy.

Following Catheterization procedure

Following the Catheterization procedure the patient is transferred to the admittance ward, where he receives VIP service, as it is our priority and policy to extend excellent care.

          Endo Pills - 11        
Informação cientifica de ação rápida

Ano 3 N° 11

Curso de Especialização em Endocrinologia - PUC

Instituto Estadual de Diabetes e Endocrinologia Luiz Capriglione

Prof.: Luiz César Povoa (A47)

Ricardo Martins Rocha Meirelles (A37)

Editores: Rosa Rita Santos Martins (A33) e Isabela Bussade (A6)

Editores Associados: Walmir Coutinho (A21), Edna Pottes (A34) e Claudia Pieper

Composição Gráfica: Wallace Margoniner

Iniciamos o terceiro ano do Endopills o que nos deixa muito orgulhosos. Para os novos que chegam, a nossa proposta é fazer uma publicação produzida pelos alunos para os alunos com informações médicas atualizadas e resumidas sobre trabalhos a serem publicados ou recém publicados além da discussão de caso clínico e opinião de especialistas convidados para discutirem assuntos “palpitantes”.Graças ao trabalho meticuloso, dedicado e competente da Dra Rosa Rita foi possível chegarmos até aqui. Conduzindo como exímia maestra, junto aos professores Dr. Luiz César, Dr.Ricardo e os editores Dr. Walmir,Dra Edna e Dra Claudia, a seleção, correção e edição dos textos trabalhados pelos alunos, Dr Rosa foi ,é e sempre será fundamental neste projeto inovador. Considerando a admiração que temos pro ela, temos juntos um desafio e espero contar com todos: manter a qualidade do EndoPills e como fruto colher mais conhecimento e sabedoria para exercermos cada vez melhor a endocrinologia.

Isabela Bussade


Mulher de 59 anos admitida no hospital local com história de crescimento excessivo de pêlos na região da face, braços e parede abdominal associada a calvície com padrão androgênico.A paciente estava em amenorréia há 4 anos.

Sua história patológica pregressa incluía diabetes tipo 2 , hipertensão arterial , tireoidectomia e síndrome de ovários micropolicísticos.

A avaliação clínica inicial revelou níveis elevados de testosterona (8,9nmol/L, ref <2,5), índice de testosterona livre (31,8, ref 0-7) e androstenediona (13,7nmol/L, ref <6,8).SHBG e DHEA estavam normais. Os exames de imagem da supra renal e ovários, TC e RM , estavam normais.Dosagem de esteróides na urina de 24 horas foi normal.

Teste com baixa doses de dexametasona revelou supressão do cortisol, mas apenas 20% e 40% de supressão de testosterona e androstenediona.A resposta de 17OH progesterona ao estimulo de ACTH foi normal com pico de androstenediona(>200) na veia adrenal esquerda.


1. Considerando esta amostra venosa você repetiria os exames de imagem?

2. Você indicaria administração de GnRH como próxima etapa no diagnóstico?

3. É possível tratar-se de malignidade?



Um estudo epidemiológico durante 8 anos na Austrália mostrou que as estatinas e os fibratos diminuem significantemente o risco do desenvolvimento de neuropatia periférica sensorial diabética.

A média de idade dos participantes no início do estudo foi de 64 anos, com diabetes diagnosticado há 4 anos sendo 48,8% homens e 30,9% destes apresentavam neuropatia.

A idade, duração do diabetes, obesidade, glicemia de jejum, hipertensão sistólica, taxa de albuminúria urinária e raça foram fatores independentes no risco para neuropatia diabética, enquanto os fibratos foram associados com redução de 70% da prevalência de neuropatia periférica.

Parece que os benefícios desses medicamentos são efeitos de classe das drogas. Enquanto vários mecanismos já foram propostos, o mecanismo de ação da neuropatia permanece desconhecido. A grande teoria em relação as estatinas esta relacionada com a redução da inflamação e estresse oxidativo.

Segundo o organizador do estudo, pessoas com diabetes devem usar essas drogas para proteção cardiovascular e para proteção de neuropatia. Apesar da escolha entre utilizar fibratos ou estatina não ser fácil, as estatinas em geral são as drogas de primeira linha devido a elevada evidencia dos benefícios de prevenção cardiovascular. Lipid –lowering drugs protect against peripheral diabetic neuropathy.In Diabetes Today http://www.diabetes.org

Fabiano Marcel Serfaty (R2)


A saliva pode ser um marcador tanto para atividade de doença periodontal como para hiperglicemia em diabetes tipo 2 descompensado, de acordo com uma nova pesquisa.

Carol W. Bassim, MD, pesquisador do Instituto Nacional de Saúde, em Bethesda, Maryland, Estados Unidos, notou que a saliva tem muito potencial como um marcador para doença em periodontite e diabetes tipo 2.

"Nós estamos vendo que a saliva pode ser um meio para verificar doença periodontal e diabetes, mais do que o controle sérico", disse Dr. Bassim. "Nós sabemos que a inflamação e a infecção em doença periodontal é associada com o mau controle do diabetes tipo 2".

Investigadores estudaram prospectivamente indivíduos que apresentavam periodontite severa ou doença periodontal moderada. Todos tinham diabetes tipo 2 descontrolada. Especificamente, eles mediram procalcitonina salivar e correlacioram com o controle glicêmico no diabetes.

"Nós sabemos que se você fica séptico, por um momento, e tem inflamação ou infecção sistêmica severa, o nível de procalcitonina aumenta significativamente" disse Dr. Bassim.

Dr. Bassim e colegas coletaram amostras da saliva total não estimulada através de expectoração de 22 pacientes com periodontite e diabetes tipo 2 descontrolado; sua HbA1C excedia 7.0. Eles também realizaram um exame periodontal completo e coletaram sangue de cada indivíduo.

A Pro CT salivar correlaciona se com sangramento gengival que indica doença periodontal ativa. Em adição, a Pro CT salivar foi correlacionada com a HbAlC, nas medidas basais e em três meses na visita de acompanhamento, não se correlacionando diretamente com a HbAlC. Mais ainda, níveis séricos de Pro CT não se correlacionaram nem com os indicadores periodontais, nem com o controle glicêmico. Níveis séricos de Pro CT estavam diminuídos comparados aos da saliva: 92 vs. 246 pg/ml. “Quantidades salivares parecem importar mais do que as séricas", observou Dr. Bassim.

Pesquisas futuras podem levar a um potencial biomarcador salivar para periodontite e diabetes tipo 2 mal controlado, de acordo com Dr. Bassim.

"Não há teste fácil e rápido para periodontite", disse Dr. Bassim. "Seria maravilhoso ter um biomarcador como a saliva neste sentido. Para os endocrinologistas, seria um meio rápido e fácil de observar os valores de HbA1C em uma aplicação clínica e acompanhar estes valores." Procalcitonin: a salivary biomarker for periodontal disease activity and hyperglycemia in uncontrolled type II diabetes. Abstract P2-231 89th Meeting of Endocrine Society.http://www.diabetesincontro.com/results

Mariana Aparecida Machado Teixeira (C2)


Mulheres que tiveram diabetes gestacional podem ter um risco maior de desenvolver câncer de pâncreas, de acordo com pesquisadores americanos e israelitas, os primeiros a correlacionar as duas doenças.

Estudos prévios mostraram que pessoas com diabetes mellitus tipo 2 tem risco aumentado de câncer de pâncreas, mas os novos resultados mostram uma ligação com uma forma menos comum de diabetes causada pela liberação de determinados hormônios e ganho de peso durante a gravidez.

Câncer de pâncreas é particularmente letal devido ao diagnóstico tardio e apenas 5 % das pessoas com a doença sobrevive por 5 anos. Mais de 200 000 novos casos são diagnosticados anualmente no mundo. Mary Perrin, uma pesquisadora da New York University's School of Medicine, disse que os dados novos precisam ser confirmados em estudos futuros, mas são importantes porque o diabetes gestacional parece aumentar a taxa de risco para obesidade.

Em décadas recentes, o diabetes tomou se mais comum nos Estados Unidos e em outros lugares, em parte devido ao crescimento das taxas de obesidade. É estimado que 20,8 milhões de americanos tenham diabetes, principalmente o tipo 2. Alguns estudos têm mostrado que o diabetes pode ser o sintoma inicial do câncer de pâncreas.

Neste estudo, os pesquisadores analisaram os prontuários de 40000 mulheres que deram a luz entre 1964 e 1976 em Jerusalém. Devido aos registros detalhados feitos em Israel, os pesquisadores puderam encontrar essas mulheres e avaliar quantas desenvolveram câncer de pâncreas numa fase tardia da vida. O estudo mostrou que mulheres diagnosticadas com diabetes gestacional em uma ou mais gestação, tinham risco 5 vezes maior de desenvolver câncer de pâncreas.

Os achados representam um nível estatístico significativo do risco e estudos futuros para correlacionar as duas doenças, disse Perrin. Ela acrescentou que o risco absoluto foi muito baixo.

"Realmente é necessário ser confirmado em outros estudos, mas não deve alarmar quem teve diabetes gestacional de que elas são destinadas a ter câncer de pâncreas", disse ela.

Gestacional diabetes linked to câncer. In Diabetes in control.com http:www.diabetesincontrol.com

Katiuscia de Carli Loureiro (C2)



O ácido zoledrônico é um bisfosfonato de terceira geração, o mais potente disponível no mercado. Os estudos pré clinícos de toxicologia demonstraram um perfil farmacológico similar ao dos outros bisfosfonatos. A formulação aprovada recentemente pelo FDA e ANVISA, para tratamento da osteoporose, contém 5 mg de ácido zoledrônico e 100 mg de manitol e citrato de sódio como excipiente e deve ser administrada em infusão venosa durante 15 minutos. A droga atua na via do mevalonato inibindo a enzima farnesyl difosfato sintase, reduzindo a atividade osteoclástica e promovendo a sua apoptose sem comprometer a formação óssea ou a mineralização óssea. A via venosa tem sido proposta em decorrência da observação de intolerância esofágica e baixa adesão a longo prazo dos bisfosfonatos orais.

Estudos clínicos demonstraram que os bisfosfonatos produzem um rápido efeito anti reabsortivo aumentando a BMD da coluna lombar e do fêmur proximal após 1 ano e resultados preliminares demonstram redução do risco de fraturas vertebrais e não vertebrais em pacientes de alto risco. Os marcadores de reabsorção óssea permanecem suprimidos durante 12 meses após o uso da droga. Os eventos adversos mais comuns são sintomas "flu like" (febre, mialgia, coriza) e náuseas, que podem melhorar com o uso preventivo de paracetamol. Insuficiência renal e necrose tubular renal têm sido relatadas após uso de ácido zoledrônico e, portanto a droga não deve ser usada em pacientes com clearance de creatinina menor que 30 mi/min. Devemos estar atentos par o risco de hipocalcemia principalmente em pacientes com fatores de risco, como a deficiência de vitamina D ou síndromes de má absorção. A osteonecrose da mandíbula tem sido relatada com maior freqüência após o uso dos bisfosfonatos injetáveis e a história de cirurgia dental recente ou extração dentária, infecção ou trauma são contra indicações ao uso do ácido zoledrônico.

Estudos clínicos de longo prazo e com maior número de pacientes são necessários, ao nosso ver, para confirmar a eficácia e segurança no tratamento da osteoporose.

Luiz Henrique de Gregório



Os exames de imagem foram repetidos e mantiveram-se sem alterações.

A paciente foi encaminhada a um serviço de referencia para investigação onde foi administrado análogo de GnRH( Buserilin por 4 semanas) que reduziram de forma significativa os níveis de androgênios tendo sido feito diagnostico de hiperandrogenismo ovariano e a mesma encaminhada para cirurgia.

O histopatológico de mostrou hiperplasia estromal difusa sem evidencia de malignidade.

A função ovariana pós menopausa está associada com redução de folícluos produtores de estradiol e células granulosas com persistência de células do estroma medular.O diagnóstico diferencial se faz com tumor de células produtoras de androgênios e hiperplasia estromal. A paciente tinha história previa de PCO e ainda não é claro até que ponto estes achos histopatológicos possam representar a evolução a longo prazo do PCO, uma proliferação celular característica do período de peri pós menopausa, ou uma combinação de ambos.
          Endo Pills - 10        
Informação cientifica de ação rápida

Ano 2 N° 10

Curso de Especialização em Endocrinologia - PUC

Instituto Estadual de Diabetes e Endocrinologia Luiz Capriglione

Prof.: Luiz César Povoa

Ricardo Martins Rocha Meirelles

Editores: Rosa Rita Santos Martins e Isabela Bussade

Editores Associados: Walmir Coutinho, Edna Pottes e Claudia Pieper

Composição Gráfica: Wallace Margoniner

Chegamos ao final do segundo ano do Endopills. Neste período tivemos sempre em mente o objetivo do Dr. Luís César Povoa: um folhetim feito pelos alunos para os alunos com o objetivo de fornecer informações sobre trabalhos a serem publicados ou recém-publicados. Com o tempo fizemos algumas modificações, como a introdução de um caso clínico, artigos de revisão e atualizações. Com este número encerro minha colaboração com o Endopills, com a certeza de que nada contribui mais para o crescimento de uma idéia do que a sua renovação, assim a partir do próximo número a edição estará sob a responsabilidade da Dra. Isabela Bussade. Agradeço a todos os alunos que nestes dois anos colaboraram com o sucesso deste trabalho.

Rosa Rita dos Santos Martins


Uma mulher de 45 anos com história de falência ovariana prematura (POF) desde os 35 anos e hipotireoidismo diagnosticado aos 40 anos faz terapia de reposição hormonal diária com 2mg de estradiol e 2,5 mg de medroxiprogesterona. Tem cariótipo normal e Ultra-som transvaginal também normal. Sua densidade mineral óssea é adequada. Na história familiar duas irmãs gêmeas dizigóticas, uma delas também com diagnóstico de POF e uma terceira irmã com 30 anos em tratamento para infertilidade e um irmão com dificuldades de comportamento, sem especificar quais.

Pergunta-se: Com essa história familiar qual conduta você recomendaria?

a) suspender a medicação e realizar a prova de LH-RH.

b) repetir o cariótipo.

c) pesquisar, por técnica de biologia molecular, mutações do gene FMR1.

A resposta e discussão estão no final do Endopills.



A maioria das candidatas à prevenção do câncer de mama não aceita usar o tamoxifeno por perceberem uma relação custo-benefício desfavorável. Atualmente os risco potencias para este câncer são: história familiar, idade, atipia celular em biópsia de nódulos benignos e fatores reprodutivos. Seria importante avaliar aquelas em que o risco é realmente elevado para o risco de câncer de mama. A densidade mamográfica, fator de risco mais importante, não é rotineiramente empregado. Os níveis plasmáticos de estrogênio e androgênio, densidade óssea, ganho de peso, idade da menopausa e história de fratura são também potencialmente importantes, mas não têm sido usados em um modelo compreensivo de predição de risco, devido à falta de validação em estudos prospectivos. Um grupo colaborativo de Prevenção do Câncer de Mama se reuniu para examinar criticamente e, por análise multivariada, os fatores de risco que poderiam ser selecionados usando o material clínico já existente para indicar quais mulheres se beneficiariam do uso preventivo do tamoxifeno. Santem, R. et al. Critical assessment of new factors for breast cancer: considerations for development of an improved risk prediction model. Endocrine-Related Cancer, 14(2) 167-187, 2007.

Vicente Lopes da Silva Júnior (R1)


Citrato de clomifeno (CC) é uma droga chave prescrita na infertilidade anovulatória, porém estudos recentes indicam que a metformina também pode induzir ovulação em pacientes com SOP. Stefano Palomba e cols da Universidade de Magna Graecia, na Itália, compararam a eficácia da metformina com o clássico tratamento com CC. Foram incluídas no estudo pacientes com SOP e infertilidade anovulatória, pareadas para idade e IMC. Não houve diferença estatística no sucesso da indução da ovulação entre metformina e CC (55,4% vs 59,8%), no número de gestações por ciclo ovulatório (10,8% vs. 11,2%) e no número de abortos (19,5% vs 26,3%). A taxa cumulativa de gestações (62,9% vs 48,6%) também não variou significativamente. Entretanto, houve diferença nas respostas clínicas. O tempo médio para a primeira gravidez com o uso de metformina foi de sete meses e de cinco meses nas pacientes em uso de CC. A taxa de gravidez por ciclo ovulatório foi constante para metformina; enquanto que mais de 70% das gestações ocorreram durante os primeiros três ciclos do tratamento com CC. O estudo demonstrou que ambas, metformina e CC, são tratamentos eficazes para infertilidade em pacientes com SOP. Estudos mais longos são necessários para determinar se a metformina pode ter um resultado clínico melhor, embora seja reconhecida a ação mais rápida do CC. Palomba S et al. Clomiphene Versus Metformin for Ovulation Induction in Polycystic Ovary Syndrome: Barbieri J Clin Endocrinol Metab.2007; 92: 3399-3401.

Aline Pereira Pedrosa (R1)


Em humanos os mecanismos moleculares envolvidos no recrutamento e ativação do folículo ovariano que controlam a reprodução feminina, menopausa e doenças como falência ovariana prematura (POF), são pouco compreendidos. Estudos prévios sugerem que o inibidor 1B quinase ciclina dependente poderia retardar o crescimento do ovócito e o desenvolvimento folicular. Singareddy Rajareddy, Kui Liu e cols têm estudado o desenvolvimento ovariano controlado pela p27 em camundongos através da hipótese de que a p27 suprimiria o recrutamento e a ativação folicular e promoveria a morte folicular. Os pesquisadores descobriram que camundongos com a p27 ausente (p27 -/-) tinham a ativação de folículos pós-natais acelerada e o dobro de folículos recrutados em relação aos camundongos p27+/+. A ausência de p27 nos ovários causou ativação prematura do “pool” de folículos primordiais e impediu a morte folicular maciça que normalmente ocorre antes da maturação sexual. Ativação excessiva do “pool” folicular em camundongos p27-/- deixou estes ovários amplamente exauridos de folículos no início da vida adulta, causando POF. Os autores estudaram exaustivamente os mecanismos moleculares envolvidos no controle do desenvolvimento folicular por mecanismos diversos nas diferentes etapas do desenvolvimento ovariano e concluíram que o gene p27 é importante na determinação do desenvolvimento ovariano dos mamíferos. Desta forma, o estudo fornece uma idéia sobre o papel das mutações genéticas que causam infertilidade e defeitos na folículogênese. Rajareddy S, Reddy P, Du C, et al. p27kip1 (Cdkn1b) controls ovarian development by supressing follicle endowment and activation, and promoting follicle atresia in mice. Mol Endocrinol. 21(9):2189-2202.

Carolina Preissler (C1) e Caroline Wust do Nascimento Gaya (C1)


Em estudo pioneiro de como o peso corporal pode afetar a assiduidade escolar, pesquisadores da Universidade da Pensilvânia apontaram o sobrepeso infantil como um grande fator de risco de ausência escolar em relação aos alunos com peso corporal normal. O estudo envolveu mais de 1000 estudantes de 4ª, 5ª e 6ª séries de escolas da Filadélfia e determinou que o índice de massa corporal (IMC) é um fator determinante significativo do não comparecimento escolar, assim como idade, etnia, nível socioeconômico e sexo, considerados formalmente como os quatro principais preditores. Verificou-se ainda que alunos com sobrepeso faltam em média 20% mais que os demais com peso normal. Segundo os autores o que os mantém longe da escola, mais do que as questões de saúde são o estigma e a intimidação que essas crianças sofrem. Novos trabalhos devem explorar esse aspecto danoso que acompanha o sobrepeso. As taxas de obesidade na infância triplicaram nos EUA nos últimos 25 anos. Além dos 4 indicadores tradicionalmente descritos, verificou-se que a combinação de sexo masculino e pior nível socioeconômico aumentaram consideravelmente a ausência escolar, contudo, o IMC se tornou o melhor indicador de falta de assiduidade do que os 4 indicadores já descritos. Essa pesquisa foi apoiada pelo National Institute of Health, e seus achados se encontram disponíveis na edição de agosto do jornal Obesity e também no endereço eletrônico http://www.docguide.com .

Carlos Eduardo Santos (R1)


Uma deficiência de tiamina (vitamina B1) pode ser a chave dos problemas vasculares em pacientes diabéticos tanto do tipo 1 quanto do tipo 2 da doença. A incidência do diabetes vêm aumentando e um dos problemas dessa patologia é sua associação com complicações micro vasculares com dano ao rim, a retina e aos nervos periféricos e complicações macro vasculares, tais como a doença cardíaca. Em um artigo publicado na revista Diabetologia, foi citado que a concentração de tiamina no plasma do sangue estava 76% diminuída no tipo I diabético e 75% no tipo 2. Estudos passados tinham considerado a atividade normal desta enzima e supunham níveis normais de tiamina quando de fato a atividade da enzima era normal devido às quantidades aumentadas de duas proteínas THTR-1 e RFC-1 que ajudam a transportar a tiamina em glóbulos vermelhos. Os níveis aumentados destas proteínas era uma resposta direta pela deficiência de tiamina no corpo. Os autores concluíram que a baixa concentração de timina é prevalente em pacientes com diabetes tipo 1 e 2, associado a um clearence aumentado da tiamina. Thornalley, J. et al. High prevalence of low plasma thiamine concentration in diabetes linked to a marker of vascular disease. Diabetologia, Volume 50 (10): 2164-2170, 2007

Nathalia Fernandes dos Santos (C1 )



Um novo estudo do Centro para controle e prevenção de doenças (CDC) mostra que a prevalência da diabetes cresce 5% anualmente desde 1990, e que esta tendência de incidência coincide com os dados de prevalência, de acordo com os registros apresentados na 67a Sessão Científica Anual da Associação Americana de Diabetes. Segundo a Dra. Linda S. Geiss, M A, chefe do serviço de vigilância de diabetes (Diabetes Program, Center of Disease Control and Prevention), este aumento está intimamente relacionado com o crescimento da obesidade e se os sistemas de saúdem quiserem resistir ao fardo crescente do diabetes, precisam aprimorar esforços preventivos. O diabetes pode levar a complicações fatais ou severamente debilitantes, como doenças cardíacas, cegueira, doença renal e amputações. O diabetes tipo 2, que responde por 90 a 95 % de todos os casos diagnosticados de diabetes, envolve resistência insulínica - a incapacidade do organismo de usar adequadamente a sua própria insulina e costumava ocorrer principalmente em adultos, acima do peso e com 40 anos ou mais, entretanto como crianças e adolescentes vem se tornando cada vez mias inativos e com peso acima do normal este quadro tem ocorrido em pessoas mais jovens. O estudo usou os dados de 1963 a 2005 de um levantamento de saúde nacional, para obter taxas de prevalência e incidência para idade e seus desvios-padrão. Foram identificados três períodos distintos na taxa de diabetes existente na população em um determinado tempo: 1963 a 1975, entre 1975 e 1990 e de 1990 a 2005. Neste último período a incidência de novos casos de diabetes aumentou de 4 a 7,7 por 1000 (5,1% anualmente). Os autores dão várias hipóteses para explicar as diferenças nas incidências, entre elas a observação da contribuição da obesidade crescente para a ascensão do diabetes iniciada em 1990. Todos os dados desse trabalho podem ser acessados pelo site www.diabetes.org.

Mariana Aparecida Machado Teixeira (C 1)


Inicialmente pensada como uma forma rara de hipertensão, atualmente o hiperaldosteronismo primário é uma causa bem definida de elevação da pressão arterial, correspondendo a 5-13% dos pacientes hipertensos. O tratamento visa à redução da morbimortalidade associada com hipertensão e dano cardiovascular. Originalmente, o hiperaldosteronismo não era suspeitado, a menos que o paciente apresentasse hipertensão e hipopotassemia espontânea. Atualmente, sabemos que a maioria dos pacientes não apresenta essa hipopotassemia. A identificação dos casos está baseada na dosagem de aldosterona e da atividade da renina plasmática. Um teste positivo deve ser confirmado com teste de supressão com sobrecarga oral de sódio para avaliar secreção autônoma. A etapa final do diagnóstico consiste em diferenciar entre os sete subtipos do hiperaldosteronismo primário, já que o tratamento varia de acordo com cada subtipo. O adenoma produtor de aldosterona (APA) e o hiperaldosteronismo bilateral idiopático são os subtipos mais comuns. A adrenalectomia unilateral em pacientes com APA ou hiperplasia adrenal unilateral resulta em normalização da hipocalemia; nas formas bilaterais de hiperaldosteronismo primário a adrenalectomia unilateral raramente corrige a hipertensão e os pacientes devem ser tratados com antagonistas do receptor mineralocorticóide. Primary aldosteronism: renaissance of a syndrome. Clinical Endocrinology 66(5): 607-618, May 2007.

Rachel Gazzola Giovanella (C2)



A Nanotecnologia permite aos cientistas trabalharem com produtos e substâncias tão pequenas que são medidas em nanoescala, com o tamanho equivalente a bilionésima parte do metro. Por exemplo, a espessura de uma folha de papel e do cabelo humano equivalem, respectivamente, a 100.000 e 80.000 nanômetros. Esta nova e promissora tecnologia vêm despertando grande interesse no mundo científico e industrial. Em 1990, aproximadamente 1000 publicações científicas foram identificadas, ao passo que em 2002 o número de publicações nessa área subiu para 22.000. Esse crescimento exponencial foi resultado de grandes descobertas e investimentos da qual vem resultando numa intensa e contínua modificação dos produtos que deverão ser regulamentados pelo FDA. Desta forma, a partir de julho deste ano, o FDA, através da então denominada “Força Tarefa em Nanotecnologia”, liderada pelo Dr. Von Eschenbach, passou a apresentar como objetivo direcionar e regularizar cientificamente o desenvolvimento desta nova tecnologia, liberando assim um relatório de recomendações sobre os benefícios e riscos da tecnologia em nanoescala. Este grupo tem como responsabilidade formar e manter um programa de desenvolvimento e pesquisa para desvendar o grande potencial da nanotecnologia, facilitando a transferência desta nova tecnologia para os produtores de modo a promover o crescimento da economia, empregos e outros benefícios públicos, além de desenvolver recursos educacionais para suportar a infra-estrutura e as ferramentas necessárias para o avanço dessas pesquisas. As substâncias em nanoescala geralmente têm propriedades químicas, físicas e biológicas diferentes que modificam suas características eletro-magnéticas, interferindo significativamente nas atividades químico-biológicas, o que lhe conferem superioridade de ação. Estudos em laboratórios determinam que a superfície de área por unidade de volume (massa) e a carga elétrica (+/-) são os principais determinantes das interações biológicas . Assim, quaisquer modificações no tamanho ou mudança na carga elétrica de uma determinada substância podem determinar grandes diferenças de interação. Por exemplo, vesículas lipídicas, carregadas positivamente, têm a capacidade de induzir edema cerebral, ao contrário daquelas neutras ou negativamente carregadas. Modificações da superfície de materiais como surfactantes e polímeros biocompatíveis (PEG) têm sua toxicidade reduzida in vitro e alterada a sua meia-vida e deposição tecidual in vivo. Desta forma, as interações biológicas são influenciadas particularmente pela composição físico-química de substâncias em nanoescala, bem como pela superfície de área independentemente da sua massa. Organizar e desenvolver estudos usando a farmacocinética, fisiologia e características como tipo, tamanho, carga elétrica e superfície das partículas em nanoescala será particularmente útil para a compreensão geral das suas interações biológicas. Por isso, o FDA terá que treinar e capacitar membros que deverão ter vastos conhecimentos na área de farmacologia, toxicologia, biologia, física, química e medicina para regulamentar as decisões a serem aprovadas por esse órgão na área de nanotecnologia. Uma das grandes dificuldades para a regulamentação das nanosubstâncias se encontra no fato dos testes in vitro serem incapazes de determinar real segurança, uma vez que avaliam um único ou poucos tipos celulares. A detecção e estudo dos materiais em nanoescala em certos produtos necessitam de equipamento altamente sofisticados, caros e de mão de obra extremamente especializada, que parecem estar pouco disponíveis até o momento. Eles vem sendo desenvolvidos e estudados não só na área de farmacologia como também nas áreas de materiais médicos, indústria alimentícia e cosmética. Desta forma, o FDA e as 22 outras agências federais que fazem parte da NNI (National Nanotechnology Initiative) não estão medindo esforços para a realização de pesquisas e programas de desenvolvimento para o estabelecimento de coordenadas para o uso eficaz e seguro dessa promissora forma de tecnologia, que parece ser indispensável para a criação de novas abordagens diagnósticas e terapêuticas na área de biomedicina assim como também nas áreas cosméticas e da indústria alimentícia. Veja o relatório completo no site www.fda.gov/nanotechnology/taskforce/report2007.pdf.

Cátia Ferreira de Araújo



A história familiar da paciente sugere a presença nessas mulheres da pré-mutação ou da mutação do Sítio Frágil do Cromossomo X, que ocorre em 3.3% nas formas esporádicas de POF e em 12% a 16% dos casos familiares. A pré-mutação é definida como a presença de 56 a 199 repetições dos nucleotídeos CGG na região não traduzida 5' do gene FMR1 (Fragile X Mental Retardation Syndrome), mapeado na região Xq27.3. Mais de 200 repetições resultam na síndrome completa do Sítio Frágil de X nos filhos do sexo masculino. Esta síndrome cursa com retardo mental, comportamento autismo like, macroorquidismo e um fácies característico no sexo masculino. As mulheres portadoras podem ser clinicamente normais e do mesmo modo que as portadoras da pré-mutação apresentar menopausa precoce. O diagnóstico é feito pela pesquisa por Biologia Molecular do número de repetições CGG descritas acima. A história de um irmão com dificuldades de comportamento torna obrigatório o aconselhamento genético nessa família, principalmente na irmã em tratamento para infertilidade. Case studies from The Endocrine Society's Clinical Endocrinology.

Cristiane da Rocha Azevedo (C1)
          Endo Pills - 7        
Informação cientifica de ação rápida

Ano 2 N°7

Curso de Especialização em Endocrinologia - PUC

Instituto Estadual de Diabetes e Endocrinologia Luiz Capriglione

Prof.: Luiz César Povoa (A45)

Ricardo Martins Rocha Meirelles (A35)

Editor: Rosa Rita Santos Martins (A31)

Editores Associados: Walmir Coutinho (A19)

Edna Pottes (A32)

Cláudia Pieper

Composição Gráfica: Wallace Margoniner

No EndoPills deste mês nossa trajetória de estudo vai desde a revisão de uma condição clínica como a Síndrome de Mauriac a trabalhos de pesquisa básica e clínica em osteoporose, incluindo um trabalho sobre osteoporose em homens na Arábia Saudita, passando pela posição de médicos americanos sobre os hormônios bioidênticos, discussão do real papel das isoflavonas no osso, pela diminuição do nível da testosterona nos homens na era atual, um novo tratamento para os módulos tóxicos e pré-tóxicos da tireóide e três trabalhos sobre pesquisas em obesidade.

Dra. Edna Pottes Pinto


As pesquisas têm consistentemente demonstrado que a obesidade aumenta o risco de câncer. Mulheres na pós-menopausa, assim como roedores após ooforectomia, freqüentemente se tornam obesas, sugerindo a importância dos estrogênios na manutenção da composição corporal e na homeostase lipídica. Um grupo de pesquisadores de várias instituições, liderado por Shoshana Yakar, Ph.D., da Mount Sinai School of Medicine, investigou a relação entre sexo, obesidade e câncer – especificamente como o status estrogênico nas mulheres obesas afeta o crescimento de tumores. O grupo injetou em ratos, modelo C57BL/6, linhagens celulares tumorais de pulmão e de colon por via subcutânea pesquisando o aumento da velocidade de crescimento das células tumorais em ratos obesos versus ratos controle. Os pesquisadores compararam então os parâmetros metabólicos e o crescimento tumoral em ratas fêmeas ooforectomizadas e obesas intactas. As fêmeas obesas ooforectomizadas desenvolveram resistência insulínica e intolerância a glicose em níveis similares aos machos obesos. A adiposidade corporal aumentou nas fêmeas ooforectomizadas independente da dieta administrada, e o crescimento tumoral se relacionou positivamente com a adiposidade corporal. Os pesquisadores afirmam que seus dados apontam para um crescimento tumoral mais rápido em ratos obesos e que nas ratas, a ooforectomia aumenta a susceptibilidade à obesidade, resistência insulínica e crescimento tumoral, sugerindo que os estrogênios endógenos, junto com a dieta, afetam a adiposidade, a sensibilidade insulínica e o crescimento tumoral nas mesmas. O mecanismo que medeia o crescimento tumoral associado à obesidade é incerto, e os autores planejam investigar possíveis participações do processo de sinalização insulina/IGF e ligado a adipocina. Os resultados foram publicados no artigo: Yakar, S. et al., Increased Tumor Growth in Mice with Diet-Induced Obesity: Impact of Ovarian Hormones. Endocrinology, Dec 2006; 147: 5826 - 5834.

Camila Mont-Serrat (C2)


Dentre os muitos mistérios sobre o tecido adiposo estão as dificuldades de se compreender como sua localização no corpo pode ser tanto benéfica ou maléfica para saúde, como sua interação com a insulina pode predispor a obesidade e finalmente como influencia na sobrevida. O padrão de distribuição de gordura e a relação cintura/quadril são programados de modo diferente nos vários grupos étnicos e também entre indivíduos de uma mesma população, sugerindo algum padrão de hereditariedade. Pesquisas têm sugerido que a gordura intra-abdominal ou visceral (GV) estocada centralmente, como no abdome, é mais prejudicial que a gordura subcutânea (SC) estocada perifericamente. Dr. Kahn citou nesta sua apresentação a pesquisa que investiga as diferenças estruturais e funcionais entre o tecido adiposo branco nos seus dois depósitos principais no corpo e que a GV intra-abdominal, que se acumula com a idade, ligada à resistência insulínica e à síndrome metabólica, intrinsecamente, apresenta maior taxa lipolítica e produz e secreta relativamente menores taxas de leptina. O reverso permanece verdadeiro para o tecido celular SC. As GV e SC diferem não somente em função, mas talvez também nos vários tipos de células com padrões específicos de desenvolvimento e resposta ao receptor de insulina. O adipócito branco desenvolve-se tanto em precursor comum de célula marrom quanto em célula branca. O precursor comum de célula branca posteriormente se diferencia em um dos dois tipos de célula gordurosa branca-gordura visceral ou gordura subcutânea. Ele descreveu a pesquisa de seu serviço onde analisaram a expressão gênica da gordura intra-abdominal de roedores e a gordura SC ao redor, focando mais a expressão de genes de desenvolvimento do que o metabolismo. A analise inicial revelou que existem 6.174 genes diferentes entre os dois tipos de gordura e a análise posterior da expressão por “PCR em Tempo Real” encontrou 198 padrões de genes de desenvolvimento (homeobox - Hox) e destes, 12 que diferiam nos depósitos de GV e SC. Estes incluíam genes cruciais do desenvolvimento como Tbox-15, Shox2, Sfrp2 e vários outros genes Hox. Em experimento posterior, o grupo mostrou que a expressão celular desses genes era diferenciada nos dois tipos de gordura, provando que ela era autônoma nos dois tecidos. Além disso, os autores observaram também que a expressão em fêmeas foi, em muitos casos, mais alta que em machos. Sabemos que é muito importante entendermos porque algumas pessoas se tornam mais centralmente e outras perifericamente obesas e porque obesidade central pode predispor a síndrome metabólica. Este conhecimento poderá um dia tornar possível reprogramar o desenvolvimento do adipócito e atacar o problema global e nacional da obesidade. O Dr. Kahn discutiu ainda se a razão da gordura visceral ser tão ruim era não somente pelo alto poder lipolítico, mas também pela liberação de ácidos graxos livres que drenam imediatamente para o fígado onde eles podem regular o metabolismo. Inversamente, a gordura subcutânea drena perifericamente e têm menor expressão de fatores com efeitos deletérios. Suas conclusões podem ser lidas no trabalho: Kahn, R. Getting to the Bottom of Fat´s Mysteries: the importance of genes and location. ENDOCRINENEWS (February, 2007): 17-18 ou acessado pelo site http://videocast.nih.gov./PastEvents.asp, clicar em Clinical Center Grand Rounds, na data January 10, 2007.

Ana Lúcia Marinho Vinagre (C2)


A obesidade é uma doença inflamatória crônica com hipertrofia de adipócitos e formação de novas células no tecido adiposo. As células não inflamatórias do tecido adiposo seriam as responsáveis pela origem da inflamação. Pesquisas em Paris e Frankfurt levantaram a hipótese da infiltração de macrófagos afetarem a expansão da gordura com ação parácrina na diferenciação do adipócito. Experimentos em ratos sugerem que macrófagos do tecido adiposo são originados dos monócitos circulantes no sangue. Neste estudo os pré-adipócitos foram condicionados em macrófagos isolados do sangue de pacientes com sobrepeso. Foi demonstrado baixo acúmulo de lipídios e redução da expressão de marcadores “adipogênicos” e “lipogênicos”. Por causa do estímulo inflamatório marcante houve uma mudança do fenótipo dos macrófagos ativados por lipopolissacarídeos. O condicionamento de macrófagos estimulou a sinalização TF-kbeta (a chave da transcrição reguladora da inflamação), aumentou a expressão do seu gene, realizou a pró-inflamação com citocinas e induziu a proliferação dos pré-adipócitos. Os autores observaram também que se mantiveram os aumentos da expressão do gen ciclina D1 e da fibronectina da matriz. Estes e outros dados observados pelos autores demonstraram que fatores secretados pelos macrófagos inibem a formação de adipócitos maduros e possivelmente limitam a expansão de tecido adiposo em humanos. Ainda precisa ser entendido se o efeito proliferativo dos macrófagos ativados é um fator chave dirigindo a resistência à perda de peso ou à freqüente manutenção do peso em sujeitos obesos. A metodologia, os resultados e a discussão deste trabalho devem ser dos conhecimentos de todos os médicos que se interessam por pesquisas em obesidade e podem ser buscados on line (com acesso livre ao trabalho) ou na referência: Lacasa, D. et al. Macrophage-Secreted Factors Impair Human Adipogenesis: Involvement of Proinflammatory State In Preadipocytes. Endocrinology (2007) Vol. 148, No. 2 868-877.

Carolina de Abreu Gonçalves Mergulhão (C2)


O Fator de Crescimento Insulina-símile 1 (IGF-1) tem sido estudado por seu possível papel protetor nas doenças degenerativas. Pesquisadores liderados por Olívia I. Okereke M.D., S.M., na Brigham and Women’s Hospital em Boston, examinaram a relação dos níveis plasmáticos do IGF-1 na meia-idade com a cognição na vida tardia. Usando amostras de sangue obtidas em 1982-1984 (idade média de 57 anos) do Physicians’ Health Study II, o grupo mediu o IGF-1 livre em 376 homens e IGF-1 total e IGFBP-3 em 460. Começando em 2001, eles aplicaram a Entrevista Telefônica de Status Cognitivo (TICS) e testes de memória verbal e fluência. Usando o score do TICS e da memória verbal, e um score global da performance média, eles então estimaram as principais diferenças ajustadas para as multivariáveis na performance cognitiva através dos níveis do IGF-1 livre e da relação IGF-1/IGPBP-3. Os pesquisadores não observaram nenhuma diferença significativa entre o score de TICS e os níveis de IGF-1. Para a memória verbal, cada aumento de SD no IGF-1 livre esteve significativamente associado com uma diferença ajustada de 0,08U. Os resultados obtidos utilizando a razão IGF-1/IGFBP-3 não foram estatisticamente significativos. O trabalho completo pode ser acessado em: Olívia, I. et al. Midlife Plasma Insulin-Like Growth Factor I And Cognitive Function In Older Men. J of Clinical Endocrin & Metab (2006), vol. 91, (11) 4306-4312.

Camila Mont-Serrat (C2)


Os osteoblastos derivam de células tronco mesenquimais. A transição da célula tronco até o osteoblasto maduro é controlada pelos fatores de transcrição Runx2 e osterix, assim como por diversos hormônios, fatores de crescimento e citocinas. O Ror2 é um receptor tipo tirosina quinase conhecido por seu papel na morfogênese, particularmente do esqueleto derivado de cartilagem. Sua expressão aumenta durante a diferenciação das células pluripotenciais em osteoblastos e se reduz quando estes progridem para osteócitos, mostrando um papel na osteoblastogênese. Para testar esta possibilidade cientistas do Wyeth Research in Collegeville estudaram os efeitos da expressão e regulação do Ror2 na linhagem osteoblástica. Eles mostraram que a expressão deste fator em células mesenquimais através de infecção por adenovírus levou a formação de matriz extracelular mineralizada. O Ror2 estimulou a osteoblastogênese através da inibição de fatores adipogênicos e indução do fator de transcrição osterix. O mesmo efeito foi demonstrado em células MC3T3-E1 (osteoblasto-like). Neste artigo os autores concluem que o Ror2 inicia o recrutamento de células tronco mesenquimais para diferenciação na linhagem osteoblástica e promove a diferenciação nas fases precoces e tardias da osteoblastogênese. O trabalho completo e a discussão dos resultados pode ser lido no artigo. Lyu Y, Bhat RA, Seestaller-Wehr LM, et al. The orphn receptor tyrosine kinase Ror2 promotes osteoblast differentiation and enhances ex vivo bone formation. Mol Endocrinol (2007): 21:376-387.

Leandro Kasuki Jomori de Pinho (R2)


De acordo com a OMS, 55% das pessoas acima de 50 anos nos EUA apresentam osteoporose. Estudos indicam uma incidência de osteoporose na pós-menopausa de 30 a 40%, e de osteopenia de mais de 60%. Na Arábia Saudita, a prevalência de mulheres com osteoporose na pós-menopausa foi subestimada por muito tempo, mas com relatos recentes de ser maior que a do Ocidente. A situação parece ser similar quando se estuda a prevalência da osteoporose na população masculina da Arábia Saudita, já que pouca atenção tem sido dada ao assunto. Neste trabalho os autores avaliaram a prevalência da osteoporose nos homens com idade acima de 50 anos da Arábia Saudita. Para isso estudaram 115 homens (61,8 ± 0,75 anos) , que não apresentavam osteoporose secundária e tinham IMC de 24,7± 0,35. Todos tiveram a DMO da coluna lombar e colo de fêmur medidos pelo DXA. Um escore “T” ≤ -2,5 DP foi o critério para osteoporose, e entre -1 e -2,5 DP para osteopenia. A prevalência de osteoporose foi de 37,4% e de osteopenia de 33,9%. A comparação destes resultados com outros dados da literatura e a discussão dos resultados podem ser lidos no trabalho: Sadat-Ali, M & AlElq, A. Osteoporosis among male Saudi Arabs: a pilot study. Ann Saudi Med (2006):26(6): 450-454

Vanessa de Aragão Sádio (C2)


A queda nos níveis de testosterona pode causar numerosas condições adversas para saúde como obesidade abdominal, diabetes, dislipidemia, perda óssea e muscular, disfunção erétil e depressão do humor. Esse declínio da testosterona é considerado normal em homens com idade avançada, entretanto um estudo recente na população dos Estados Unidos revelou uma queda inexplicável nos níveis de testosterona, idade independente, em homens a partir dos 17 anos. A hipótese deste estudo transversal discute a possibilidade do estado de saúde física e funções endócrinas do homem serem fatores causais. O estudo foi realizado com um coorte prospectivo avaliando a saúde e funções endócrinas com seleção randomizada dos homens de idade entre 49 a 79 anos. As pesquisas demonstraram evidências do decréscimo secular nos níveis de testosterona, com interferência na contagem de espermatozóides e fertilidade. Este artigo pode se lido em: Travison T.C. et al. A population-level decline in serum testosterone levels in American men. J. Clin. Endocrinol. Metab. (2007): 92(1): 196 - 202.

Carolina de Abreu Gonçalves Mergulhão (C2)


Os hormônios bio-idênticos são definidos como compostos que possuem exatamente a mesma estrutura química e molecular dos hormônios produzidos naturalmente no corpo humano. Embora qualquer hormônio possa ser produzido para ser bio-idêntico o termo é geralmente usado para descrever formulações contendo estrogênio, progesterona e androgênios. A reposição hormonal é comum e um tratamento efetivo para sintomas associados à menopausa pode trazer efeitos colaterais potencialmente sérios. Pessoas fora da comunidade médica sem nenhum conhecimento científico têm afirmado que os chamados hormônios bio-idênticos, particularmente o estrogênio e a progesterona são uma terapia segura e mais efetiva quando comparada às terapias tradicionais, e indicando-as sem nenhuma informação ou segurança dos mesmos para os pacientes, pois tais hormônios não estão sujeitos a averiguações pelo FDA (Federação de Drogas e Alimentos dos EUA) no que diz respeito à dose ou pureza. Os hormônios usados na terapia de reposição hormonal são comercialmente disponíveis e suas estruturas químicas e moleculares são muito semelhantes, mas não exatamente uma réplica daqueles hormônios produzidos pelo corpo humano. A dosagem de cada hormônio usado tem sido constante dentre as mulheres que receberam tratamento hormonal. Nenhuma evidência médico-científica existe para dar suporte a idéia de que os efeitos adversos e/ou benefício encontrados resultaram da estrutura molecular dos hormônios sintetizados, nem houve nenhuma evidência científica para mostrar que uma diferença ou dose personalizada de hormônio teria um resultado diferente na doença, caso a dosagem e pureza fossem iguais. Portanto, seria esperado que todo o estrogênio contido na TRH bioidêntica ou tradicional levasse essencialmente aos mesmos riscos e benefícios. Considerando-se a fonte ou estrutura dos hormônios administrados terapeuticamente todos os regimes de TRH mesmo aqueles em tratamento “personalizados” devem ser cuidadosamente controlados. A posição da Sociedade Americana de Ginecologia e Obstetrícia, da Academia Americana de Médicos da Família, da Sociedade Americana de Endocrinologia e da Associação Médica Americana podem ser lidas na apresentação da dra. Loretta Doan em “EndocrineNews” (January 2007: Bioidentical Hormones. The Endocrine Society´s Position).

Maria da Saúde de Oliveira (C2)


Apesar da reposição estrogênica reduzir a reabsorção óssea, a preocupação com seus efeitos colaterais negativos levou a uma procura por tratamentos alternativos, dentre eles a isoflavona de soja. Para identificar a dose necessária para aumentar a massa óssea pesquisadores da Purdue University conduziram um estudo utilizando espectrometria de massa e marcadores de reabsorção óssea no intuito de detectar baixas relações cálcio41/cálcio urinário. O novo método permite medir o impacto do tratamento anti-reabsortivo no intervalo de dias a semanas, ao invés de seis meses a anos. Em estudo duplo-cego, randomizado, os pesquisadores administraram 41cálcio intravenoso em 13 mulheres pós-menopausa. Após um período de 200 dias, as participantes do estudo receberam por 50 dias, 43 gramas de proteína de soja que continham 0 mg, 97,5 mg ou 135,5 mg de isoflavona. A cada 10 dias amostras de urina de 24 horas foram coletadas para medida da relação 41cálcio/cálcio. Os pesquisadores observaram que nenhuma dose de isoflavona influenciou a reabsorção óssea ou a absorção de cálcio. Os marcadores séricos e urinários de formação e reabsorção ósseos permaneceram inalterados, apesar do reconhecimento por parte dos pesquisadores de que o estudo não tem poder estatístico para mostrar diferenças nestes marcadores. Além disso, o estudo incluiu mulheres com mais de quatro anos pós-menopausa, já passada a fase de perda óssea rápida. A conclusão dos pesquisadores é de que seu estudo tem resultados semelhantes ao de outros estudos em humanos e animais, que mostram que a isoflavona de soja não afeta a perda óssea, apesar de outros estudos terem mostrado o contrário. A discussão sobre essas divergências pode ser lida no trabalho Cheong JMK et al. Soy isoflavones do not affect bone resorption in postmenopausal women: A dose response study using a novel approach with 41Ca. J Clin Endocrinol Metab (2007). N. 92:2577-2582

Leandro Kasuki Jomori de Pinho (R2)



Nódulos tireoidianos hiperfuncionantes constituem cerca de 4% dos nódulos tireoidianos. Podem ser solitários ou, mais comumente, fazer parte de um bócio multinodular (BMN). Sintomas geralmente se manifestam quando os nódulos são suficientemente grandes para serem capazes de produzir quantidade de hormônio tireoidiano que diminui o nível de TSH. A importância dos sintomas depende da idade do paciente e da presença de doenças subjacentes, principalmente cardiovasculares. A ablação percutânea por laser (APL) tem sido usada de modo experimental e clinico em ablação de tecido tumoral. Entretanto, sua utilização nos nódulos tireoidianos é recente. Alguns estudos têm demonstrado que a APL pode ser capaz de diminuir o tamanho dos nódulos tireoidianos nos pacientes que apresentam contra-indicação cirúrgica ou que recusam este procedimento. Os autores deste trabalho citam algumas possíveis vantagens da APL em comparação com os tratamentos mais clássicos como: na terapia com o radioiodo, o tratamento com drogas antitireoidianas tem que ser descontinuado por certo período; na intervenção cirúrgica há o uso de anestesia geral e o custo do procedimento; a injeção percutânea de etanol nos nódulos sólidos não destrói o tecido tireoidiano de maneira regular e homogênea e pode levar a problemas relacionados à difusão do etanol nos tecidos circundantes. Os autores trataram 18 pacientes (10 mulheres e 8 homens, de 31 a 80 anos) que apresentavam um único nódulo tireoidiano hiperfuncionante ou um BMN com áreas claramente hiperfuncionantes na cintigrafia com tecnécio 99m; o tamanho máximo dos nódulos variou de 24,2 a 48,6 mm (volume de 4,7 a 39,2 ml). O tratamento foi descontinuado quando o ultra-som mostrou destruição quase completa do nódulo, que ocorreu após uma a cinco semanas (mediana, três semanas). O grupo controle constou de 64 pacientes (36 mulheres e 28 homens, 37 a 71 anos) com BMN ou uninodular tóxico ou pré-tóxico (TSH menor que 0,20 µUI/ml em pelo menos duas ocasiões), admitidos consecutivamente durante o mesmo ano. Estes pacientes foram submetidos a acompanhamento durante seis meses para detectar a possibilidade de normalização espontânea do TSH, e também nestes pacientes foi iniciado metimazol quando necessário. O número total de sessões de APL variou de um a cinco, o número usado foi baseado no tamanho da área de lesão induzida pelo laser percebida pelo controle ultra-sonográfico, realizado uma semana após cada sessão. Vinte e quatro horas após cada sessão de APL houve aumento leve e transitório dos níveis de T4 e T3 livres – de 5,2% a 18,1% (p< 0,001) nos pacientes não tratados com metimazol e de 4% a 8,3% nos pacientes tratados com metimazol; entretanto nunca atingiram valores de hipertireoidismo. Além disso, a tireoglobulina apresentou aumento importante após 24 horas – 115% a 390% (p< 0,001). O TSH aumentou em todos os casos e atingiu valores normais em todos os pacientes com nódulo único e em cinco pacientes (50%) com BMN em três meses. Em dois pacientes, o TSH permaneceu temporariamente normal ou baixo apesar de valores baixos de T4 livre. Não houve aumento significativo dos anticorpos anti-TPO ou anti-tireoglobulina. O ultra-som realizado na primeira semana pós-tratamento demonstrou na área tratada, como relatado anteriormente, três regiões diferentes: fina região central anecóica, correspondendo à cavitação, uma camada hiperecóica circundante e uma camada externa hipoecóica devido à necrose. O volume nodular não apresentou alteração. No exame realizado no terceiro mês após a APL, todos estes aspectos estavam menos definidos e o volume nodular diminuiu 15% a 43% (p< 0,001). Em um ano, a diminuição do volume foi de 24% a 72% (p< 0,001) e os nódulos se mostraram menos nítidos, com áreas não homogêneas. No grupo controle, nenhum paciente apresentou normalização do TSH ou diminuição do volume nodular. Dados específicos da técnica aplicada, efeitos colaterais, intercorrências clínicas e a discussão dos resultados estão descritos no trabalho: Bárbaro, D. et al. Endocrine Practice (2007). Vol 13 (1): 30-36.

Roberta Portugal Henriques (R2)



A Síndrome de Mauriac apresenta como pontos cardinais hepatomegalia, déficit de crescimento e fácies cushingóide associado a diabetes mellitus (DM) tipo 1 mal controlado durante a infância e adolescência. Com o advento dos análogos de insulina e insulinização intensiva a incidência deste quadro tem diminuído. Neste trabalho foi descrito o paciente mais jovem já publicado com Síndrome de Mauriac, 3 anos de idade, com DM tipo 1, abdome protuberante, hepatomegalia e elevação de enzimas hepáticas. Todos esses dados se normalizaram com a melhora no controle glicêmico. Seu diagnóstico de diabetes tipo 1 havia sido realizado com 14 meses de idade, com hemoglobina glicosilada de 11,3%; a insulinização não foi adequada e o controle irregular o levou a apresentar três episódios de cetoacidose diabética em 2 anos, com uma variação de HgA1C de 13 a 17%, com elevação moderada de transaminases hepáticas sem hepatomegalia. Evidências de descaso e negligência fizeram necessário o envolvimento do Serviço de Proteção à Criança. Evoluiu com hepatomegalia, desaceleração do crescimento linear, no exame físico. Durante o diagnóstico de síndrome de Mauriac apresentava fácies de lua cheia, rotunda e com abdome distendido, glicosúria sem proteinúria; colesterol 225 mg/dl, triglicerídeos 208 mg/dl, Hg A1C 14,2%, TGO 51 U/L, TGP 146U/L, albumina 4 g/dl, TAP 11, 6 segundos, PTT 18,4 segundos, IGF-1 < 10 ng/mL e IGFBP3 0,8mg/L (0,9-4,1), hemograma, função renal, cortisol livre urinário e hormônios tireoidianos normais, testes para hepatite auto-imune, doença celíaca, doenças do trato biliar e toxicidade medicamentosa foram negativos, US abdominal mostrou grande hepatomegalia, atraso de idade óssea; após duas semanas de controle glicêmico estrito hospitalar houve redução do tamanho do fígado e após cinco meses sua Hg A1C caiu para 9,9%, sua necessidade de insulina diária caiu de 1,0 para 0,75 U/Kg, houve aumento da velocidade de crescimento, nova dosagem de IGF-1 foi de 30 ng/ml e a IGFBP-3 foi 1,3 mg/L; normalização do tamanho do fígado e das provas funcionais. Os achados do paciente batem com a descrição clássica de Síndrome de Mauriac, incluindo a desaceleração do crescimento, traços cushingóides, abdome protuberante e hepatomegalia associada ao controle glicêmico ruim de longa data. Discussão dos mecanismos envolvidos no déficit de crescimento, nos sinais clínicos e mecanismos fisiopatológicos envolvidos podem ser lidos no trabalho: Shefali Mahesh, MD et al. Mauriac Syndrome in a 3 Year Old boy. Endocrine Practice (2007), 13 (1): 63-66

Beatriz Ohana Marques Coelho de Carvalho (C2)
          Endo Pills - 5        
Informação cientifica de ação rápida

Ano 2 N°5

Curso de Especialização em Endocrinologia - PUC

Instituto Estadual de Diabetes e Endocrinologia Luiz Capriglione

Prof.: Luiz Cesar Povoa (A45)

Ricardo Martins Rocha Meirelles (A35)

Editor: Rosa Rita Santos Martins (A31)

Editores Associados: Walmir Coutinho (A19)

Edna Pottes (A32)

Composição Gráfica: Wallace Margoniner

O ENDOPILLS é mais um instrumento que criamos para aprimorar a área acadêmica. É um folheto, simples, cada vez mais eletrônico, baixando o custo, mas sobretudo trazendo resumos de artigos de ponta e até mesmo com matéria já aceitos e ainda não publicados. Mais do que isto, este folheto seria feito pelos alunos, iniciando-se a prática de ler e escrever sobre artigos científicos. Comecei, cresceu, Dra. Rosa o amadureceu, é nossa idéia que com a coordenação da equipe acadêmica, mais e mais alunos participarão.

O Endopills nasceu sadio e já tenta engatinhar sozinho. É mais um sonho que se torna realidade.

Luiz Cesar Povoa


O tratamento de mulheres osteoporóticas com paratormônio (PTH) aumenta os marcadores bioquímicos de turnover ósseo, a densidade mineral óssea do eixo axial e reduz o risco de fraturas. Entretanto, pouco se sabe acerca dos níveis basais dos marcadores de turnover ósseo e de sua resposta inicial na densitometria em mulheres pós-menopausa. Para esclarecimento destas questões pesquisadores, liderados por Douglas C. Bauer, médico, na Universidade da Califórnia em San Francisco, realizaram um estudo randomizado, controlado com placebo, do uso de PTH em 238 mulheres pós-menopausa com densidade mineral óssea (DMO) diminuída no quadril ou coluna. Eles dosaram os marcadores de turnover ósseo em amostras de sangue colhidas em jejum, antes da terapia e após um e 3 meses. Após um ano, eles analisaram a DMO na coluna e quadril. Eles encontraram relação inconsistente entre o turnover basal e as modificações na DMO após um ano. Maiores aumentos no turnover em 1 e 3 meses, especialmente do marcador de formação óssea pró-colágeno tipo I N propeptídeo, estavam associados com maiores ganhos na DMO. Análises da DMO volumétrica na coluna e quadril mostraram associação ainda mais positiva do aumento a curto prazo do turnover com ganhos na DMO em 1 ano. Os pesquisadores concluíram que, entre mulheres osteoporóticas pós-menopausa, maiores modificações a curto prazo no turnover utilizando a terapia com PTH estão associadas com maiores incrementos na DMO do quadril e coluna após um ano. Os resultados e discussão dos mesmos podem ser lidos no artigo: Bauer DC, Garnero P, Bilezikian JP, et al., for the PTH and Alandronate (PaTH) Research Group. Short term changes in bone turnover markers and bone mineral density response to parathyroid hormone in postmenopausal womem with osteoporosis, J Clin Endocrinol Metab (Apr 2006); 91: 1370-1375.

Leandro Kasuki Jomori de Pinho (R2)


Tamoxifeno, um modulador seletivo do receptor de estrogênio (RE), reduz significativamente a recorrência de tumores de mama com RE alfa-positivos, se ligando ao domínio ativador de função-2 (AF-2) do RE. Entretanto, resistência adquirida ao tamoxifeno tem se tornado um sério problema terapêutico. Neoplasias de mama resistentes ao antiestrogênico normalmente apresentam expressão aumentada dos membros da família de fatores de crescimento epidérmico, EGFR e ErbB2, porém os mecanismos envolvidos não foram comprovados. Por isso, uma equipe de pesquisadores examinou as vias de sinalização envolvidas na regulação da resistência ao tamoxifeno nas células que expressam mais o ErbB. A equipe, liderada por Kaladhar B. descobriu que a expressão aumentada do EGFR ou do AKT-2 ativado em células MCF-7 causa a fosforilação da Ser167 no domínio AF-1 do RE alfa, aumento da interação RE: AIB1 na presença do tamoxifeno, e resistência ao tamoxifeno. Pelo contrário, a transferência de um ativador imediato da proteína quinase mitogênica ativada (MAPK/Erk1&2) para as células MCF-7, leva a fosforilação da Ser118 no domínio AF-1 do RE alfa, inibindo a interação RE:AIB1 na presença do tamoxifeno, com manutenção da sensibilidade ao fármaco. A inibição do AKT pelo siRNA bloqueou a fosforilação da Ser167 no receptor de estrogênio e restaurou a sensibilidade ao tamoxifeno. Entretanto, a sensibilidade é máxima quando ambas AKT e MAPK eram inibidas. Os pesquisadores concluíram que diferentes sítios de fosforilação do domínio AF-1 no RE alfa regulam a ação agonista e antagonista do tamoxifeno nas células do câncer de mama humano. Trabalho completo pode ser lido no artigo: Glaros S. et al. Activation function-1 domain of estrogen receptor regulates the agonistic and antagonistic actions of tamoxifeno. Mol Endocrinol (May, 2006); 20:996-1008.

Leandro Kasuki Jomori de Pinho (R2)


A super expressão do andrógeno intersticial é um aspecto chave na SOP e estudos têm sugerido que pode ser causado por hiperandrogenismo fetal. Pesquisadores detectaram RNAm da enzima esteroidogênica P450c17 - a qual catalisa a conversão de pregnenolona e progesterona em seus produtos andrógenos – em ovários fetais humanos entre 14,9 e 21,5 semanas de gestação. Este é o momento que os ovários fetais começam a secretar espontaneamente dehidroepiandrosterona e androstenediona. Uma equipe de pesquisa chefiada por Gregory F. Erickson pesquisou a expressão espaço-temporal da proteína P450c17 no ovário fetal humano. Os pesquisadores estudaram os ovários de 48 controles (fetos não-anencéfalicos) e 18 fetos anencéfalicos entre 17 e 42 semanas de gestação. A proteína P450c17 foi altamente expressa nas células intersticiais primárias durante o segundo trimestre nos ovários controle. Relativamente poucas células expressaram P450c17 entre 25 e 32 semanas, mas após este período a enzima foi fortemente expressa nas células da teca. Células da teca positivas para P450c17 cresceram em abundância durante o terceiro trimestre, desenvolvendo folículos pré-antrais e expressão forte foi vista nas células intersticiais do hilo. As análises dos ovários dos fetos anencéfalos revelaram um padrão similar nas três células intersticiais, sugerindo que hormônios pituitários não estão envolvidos na expressão do P450c17 no ovário fetal humano. Em conclusão, a equipe identificou três classes de células com expressão da enzima, cada uma com um diferente padrão de expressão do P450c17 e, presumivelmente, diferentes funções fisiológicas. O trabalho completo pode ser lido no artigo: Cole B, Hensinger, K., Maciel, GAR et al. J Clin Endocrinol Metab (Sep 2006), 91:3654-3661.

Paloma Hess (C2)


Os pacientes tratados com sucesso com MHNF tendem a ter pior qualidade de vida, especialmente se apresentam múltiplas deficiências hipofisárias, apesar de estratégias de reposição hormonal adequadas, de acordo com estudo do JCE&M. No primeiro estudo de qualidade de vida relacionado a esta específica forma de macroadenoma, Olaf M. Dekkers e colegas compararam 99 pacientes adultos em remissão após cirurgia transesfenoidal e radioterapia com 125 controles. Os participantes responderam a quatro questionários validados relacionados à saúde. Na avaliação, 83% dos pacientes apresentavam deficiência de GH, 82% de LH/FSH, 63% de ACTH e 62% de TSH. Hipopituitarismo estava presente em 93 de 99 pacientes, panhipopituitarismo da hipófise anterior em 48% e diabetes insipidus em 9%. Defeitos do campo visual estavam presentes em 41% dos casos. Em cada questionário, os pacientes com MHNF relataram significativo prejuízo na qualidade de vida, incluindo maiores fadiga mental e física e menor motivação e atividade. Eles também relataram energia e reação emocional afetiva reduzidas, e limitações no âmbito social devido a problemas físicos e emocionais. A discussão dos resultados pode ser lida no artigo: Quality of life is decreased after treatment for non-functioning pituitary macroadenoma. J Clin Endocrinol Metab (Sep 2006), 91: 3364-3369.

Paloma Hess (C2)


Em animais, o ambiente adverso pré-natal pode causar alterações permanentes na atividade do eixo hipotalâmico - hipofisário - adrenal – o qual é o mediador da resposta ao stress através da secreção dos hormônios glicocorticóides. Para investigar se isso também pode ocorrem em humanos, um grupo de pesquisadores estudou se bebês a termo menores, porém saudáveis, estariam mais propensos a apresentar resposta glicocorticóide aumentada ao stress psicológico na infância. O estudo foi liderado por Alexander Jones. Os pesquisadores mediram a resposta do cortisol salivar ao stress psicológico em 68 meninos e 72 meninas, com idade entre 7-9 anos e os seguiram desde 12 semanas de gestação. Em meninos, o peso ao nascimento foi inversamente relacionado à resposta do cortisol salivar ao stress, mas não com os níveis do cortisol pela manhã, enquanto nas meninas, o pico de cortisol pela manhã foi inversamente relacionado ao peso ao nascimento. Essas associações foram independentes da idade gestacional e de outros potenciais fatores de interferência, e sugerem que determinados processos na vida fetal, resultando em recém-nascidos menores, apresentam um efeito permanente na resposta adrenocortical ao stress em meninos e na atividade adrenocortical basal em meninas. Maiores informações sobre o trabalho podem ser lidas no artigo: Jones A., Godfrey KM., Wood P. et al. J Clin Endocrinol Metab (May 2006), 91:1868-1871.

Camila Mont Serrate (C2)


Agonistas gonadotropínicos aumentam a massa gorda em homens com câncer de próstata, mas pouco se sabe sobre os efeitos desse tratamento na sensibilidade insulínica. Um grupo de pesquisadores do Hospital Geral de Massachusetts em Boston, chefiado por Matthew R. Smith, M.D, Ph.D., pesquisou os efeitos a curto prazo do tratamento com os agonistas das gonadotrofinas na sensibilidade insulínica em um estudo prospectivo em 12 semanas. O grupo estudou 25 homens não diabéticos com câncer de próstata sem evidência radiológica de metástases. Os homens foram tratados com leuprolide depot e bicalutamida. O teste oral de tolerância à glicose e a análise da composição corporal por Absortiometria com Raios-X de dupla energia foram feitos antes do tratamento e após 12 semanas. Os pesquisadores constataram que a percentagem de massa gorda, os níveis de insulina plasmática pós-prandial e a HbA1C média aumentaram significativamente do basal para a 12ª semana. Inversamente, o índice de sensibilidade insulínica e a sensibilidade insulínica pela análise do modelo homeostático diminuíram. Essas observações sugerem que os agonistas das gonadotrofinas aumentaram fortemente o risco de diabetes mellitus e doença cardiovascular em homens idosos. Os resultados e discussão dos mesmos foram publicados no artigo: Smith MR, Lee, H., Nathan D.M. Insulin sensitivity during combined androgen blockade for prostate câncer. J Clin Endocrinol Metab (Apr. 2006); 91:1305-1308.

Ana Lúcia Marinho Vinagre C2)


Diabetes Mellitus (DM) é a principal causa de insuficiência renal nos Estados Unidos. Apesar do bloqueador do receptor de mineralocorticóide (RM) ter um benefício na proteinúria nos pacientes com diabetes tipo 2, um estudo recente mostrou piora da função endotelial. Devido ao risco potencial de hipercalemia em pacientes diabéticos, o FDA (Food and Drug Administration) contra-indica o seu uso nesses casos. Entretanto, os antagonistas dos RM não tem sido estudados em pacientes que não estavam usando inibidor da enzima de conversão da angiotensina nem no diabetes tipo 1. Cientistas do Hospital de Mulheres de Brigham, em Boston, liderados por Gail K. Adler, M.D., Ph.D., investigaram se o bloqueadores do RM tem efeitos benéficos ou maléficos na nefropatia diabética. A equipe utilizou uma linhagem de camundongos tratados previamente com estreptozocina como modelo para DM tipo1, e ratos bd/bd como modelo para DM tipo 2. Ambos os grupos foram divididos em dois subgrupos para receber esplerenone, como BRM, e controles. Os camundongos e os ratos diabéticos desenvolveram albuminúria e evidência histopatológica de doença renal, bem como aumento dos níveis corticais de mineralocorticóide e de seus mRNAs, fator de crescimento transformador do mRNA, e osteopontina mRNA. Exceto por níveis elevados de mineralocorticóides, o tratamento com esplerenone reduziu significativamente essas alterações em ambas as espécies de roedores e em ambos os tipos de DM. Os efeitos benéficos não foram atribuídos as alterações na pressão arterial ou glicemia. Os investigadores sugerem que a ativação dos RM é fator crucial na patogênese precoce da doença renal tanto na DM tipo1 como no DM tipo 2. Os resultados foram publicados no artigo: Cuo C, Martinez-Vasques D, Mendes GP et al. Minerolcorticoid receptor antagonis reduces renal injury in rodent models of type 1 e 2 diabetes mellitus. Endocrinol (Nov 2006), 147:5363-5373.

Joana R. Dantas Pereira (R2)


A exposição ao iodo radioativo, especialmente I 131, após o acidente nuclear de Chernobyl, é reconhecido como fator de risco para o aumento dos casos de câncer de tireóide na população regional, entretanto evidências do aumento de tireoidite autoimune (TAI) não tem sido conclusivas. Um grupo de pesquisadores dos Estados Unidos e Ucrânia investigaram a relação entre TAI e a exposição ao iodo 131 como fator de risco determinante. Pelo fato da tireoidite autoimune ser uma doença comum que aumenta a prevalência de acordo com a idade, foi aventada a hipótese de quanto maior o tempo de exposição ao iodo 131 maior a carga acumulada da radiação nessa população. Os pesquisadores coletaram dados de uma coorte de indivíduos contaminados no local do acidente, moradores em uma região com deficiência de iodo na Ucrânia. Os indivíduos tinham menos de 18 anos na época do acidente nuclear em 26 de Abril de 1986 e tiveram a radiação da tireóide mensurada logo após o acidente. Os pesquisadores sugeriram que não havia associação significativa entre a dose de I 131 estimada e incidência de tireoidite autoimune, entretanto a prevalência de anticorpos antiperoridase (ATPO) tinha uma relação modesta, mas significativa, com discreta elevação de ATPO em indivíduos eutiroidianos. Os autores concluíram que a identificação de dose-resposta em relação ao aumento da prevalência de ATPO poderá possibilitar mudanças clínicas importantes a qualquer momento, requerendo melhor acompanhamento e análise prospectiva da coorte. Os resultados e sua discussão podem ser lidos no artigo: Tronko MD, Brenner AV, Olijnyk VA, et al. Autoimmune thyroiditis and exposure to iodin 131 in the Ukrainian cohort study of thyroid cancer and other thyroid diseases following the Chornobyl accident. Results from the first screening cycle (1998-200). J Clin Endocrinol Metab (Nov 2006), 20:2898-2908.

Carolina Mergulhão (C2)



No campo da Endocrinologia, o conceito de “possibilidades médicas” trazem a mente tecnologias de reprodução assistida, melhora da função sexual, testes genéticos preditivos, ganho estatura para crianças com baixa estatura idiopática (BEI), retardar/otimizar processo de envelhecimento. Em seu artigo publicado na revista Endocrine News (outubro de 2006) Katrina A Bramset, Ph D, discute que freqüentemente relacionado com essas “possibilidades médicas” estão argumentos sobre os objetivos da medicina, necessidades médicas, tratamento, melhora da qualidade de vida, custo, verba, e direito.

Usando BEI (baixa estatura idiopática), como exemplo, ela discute que não há consenso verdadeiro no diagnóstico de BEI, mas vários critérios são geralmente aceitos. Estes incluem uma estatura de mais de dois desvios padrões (DP) abaixo da média, a ausência de doença identificada, peso normal para idade gestacional, proporções corporais normais, ingesta calórica adequada, ausência de doença psiquiátrica, e pico de hormônio do crescimento em resposta ao teste de estimulação padrão maior do que 10 ng/ml.

Uma diretriz recente do Food and Drug Admnistration aprovou o tratamento para crianças com estatura de mais de 2,25 DP abaixo da média (totalizando aproximadamente 410.000 crianças americanas). O custo estimado com a terapia é de $ 20,000 por ano ou mais de $ 42,305 por centímetro no aumento de estatura final (dependendo do peso da criança, dose, e custo da droga).

Junto do diagnóstico e custo relacionado, existe uma significativa controvérsia sobre categorizar BEI como uma “desordem clínica” que deve ser tratada como qualquer outro problema médico, ou como uma “conseqüência” que deve ter pronta tentativa no aumento de estatura.

Discussões éticas emergem de uma questão fundamental complexa quanto a importância da estatura final. Alguns autores denominam o tratamento de BEI como “endocrinologia cosmética” e discutem que baixa estatura deveria ser considerada como uma condição social e tratada por meios baratos, não-invasivos, como terapia cognitivo comportamental.

A Dra. Katrina discute como se avalia a melhora da qualidade de vida? Há um número mínimo de centímetros ganhos (um limiar) que tenha impacto “significativo” na qualidade de vida? Há ganho em qualidade de vida proporcional com os enormes custos do tratamento? Se pessoas mais altas são realmente mais bem pagas do que pessoas mais baixas, este argumento pode apoiar a suplementação com hormônio do crescimento em uma tentativa de reduzir o risco dessa desigualdade. Entretanto, tal apoio deverá levar em consideração outras necessidades médicas da infância.

Em uma sociedade competitiva, a batalha de explorar possibilidades de conhecimento e crescimento é atraente para pais e crianças, mas qualquer ganho relacionado a medicamentos deve ser cuidadosamente pesado contra encargos financeiros e não financeiros da terapia, incluindo as aplicações de injeção e efeitos colaterais a curto e longo prazo. É importante citar que a terapia com GH não garante crescimento adicional, e a criança pode experimentar problemas psicológicos se não alcançar a estatura alvo. Pais, também, podem experimentar decepção emocional e financeira se os resultados não alcançarem suas expectativas.

O campo da endocrinologia apresenta uma gama de “possibilidades médicas”, muitas das quais muito caras. Do ponto de vista ético, o desafio é analisar o custo e o beneficio dessas terapias e identificar quais pacientes têm real probabilidade clínica de experimentar os benefícios. Muitos têm contra-indicações como história de câncer ou fibrose cística; outros têm condições crônicas com significante potencial de complicações a longo prazo como Diabetes.

A Dra Katrina termina seu artigo concluindo que em face aos recursos financeiros limitados, o uso terapêutico do GH em crianças com BEI não deve estar entre as prioridades de tratamento em Endocrinologia, dado que BEI não apresenta risco de vida e sua morbidade é geralmente superada por outras condições da infância.

Michelle Bravo (C2)
          Endo Pills - 3        
Informação cientifica de ação rápida

Ano 1 N°3

Curso de Especialização em Endocrinologia - PUC

Instituto Estadual de Diabetes e Endocrinologia Luiz Capriglione

Prof.: Luiz Cesar Povoa (A45)

Ricardo Martins Rocha Meirelles (A35)

Editor: Rosa Rita Santos Martins (A31)

Editores Associados: Walmir Coutinho (A19)

Edna Pottes (A32)

Composição Gráfica: Wallace Margoniner

O Projeto Genoma foi criado em 1990 através de dois grupos: um público envolvendo cientistas dos Estados Unidos, Inglaterra, França, Alemanha, Canadá e Japão com a direção do Dr. Francis Collins e uma empresa particular, a CELERA Genomics, sob a direção do Dr. Graig Venter. O objetivo de ambos: desenhar o genoma humano. Ambos usaram DNA de voluntários anônimos baseados no fato de que os genes codificantes de proteínas são os mesmos nos humanos. Em 2001, em conjunto, apresentaram o primeiro rascunho do genoma humano e a descrição dos genes codificantes foi considerada concluída em 2004. Estes resultados, entretanto, não incluíram a maior parte dos polimorfismos nem os genes codificantes das moléculas funcionais do RNA.

No Endo Pills deste mês apresentamos exemplos da aplicação dos objetivos do Projeto Genoma na Prática Médica: desenvolvimento de métodos diagnósticos em doenças de etiologia genética, otimização das medidas terapêuticas para essas doenças e doenças infecciosas e prevenção de doenças multifatoriais, como diabetes e hipertensão arterial.

Rosa Rita Santos Martins



O genoma humano, com seus 35 mil genes pode se considerado o manual de instruções do organismo. A Genômica estuda a estrutura individual de cada gene, além de suas interações com outros genes e com o meio. Esta ciência seria revolucionária, segundo o autor, pois promoveria a prática da “medicina personalizada”, ajudando na prevenção, diagnóstico e tratamento de doenças.

A medicina personalizada tenta responder a perguntas como: porque algumas pessoas desenvolvem câncer e outras não; porque o câncer é mais agressivo em determinada pessoa; porque determinada droga, ou dose, funciona para alguns e não para outros? Seu alvo é conseguir os melhores resultados terapêuticos para o perfil genético específico de cada paciente, podendo auxiliar inclusive familiares, médicos e na evolução de outros testes diagnósticos não genômicos.

A combinação da Farmacologia com a Genômica originou a Farmacogenômica, que é uma ciência que permite aos cientistas predizer a probabilidade de uma droga responder baseado no perfil gênico de uma pessoa. Segundo o Dr. Larry Lenko, do FDA, há três maneiras principais de se aplicar a Farmacogenômica:

• A primeira é a de ajudar a predizer a dose apropriada de uma determinada droga. Os genes regulam o metabolismo dos medicamentos. Diferenças na seqüência de um gene podem causar diferenças na atividade enzimática, resultando em diferentes apresentações dessas enzimas em cada indivíduo.

• A segunda é a de criar terapias específicas para cada doença, por alguns chamada de Genômica Tumoral. Testes genômicos têm ajudado na identificação de tumores que respondem melhor a um tratamento específico. Lenko cita drogas Gleevec (Imatinib) para leucemia mielóide crônica, Tarceva (Erlotinib) para câncer de pulmão e Herceptina (Transtuzumab) para câncer de mama como exemplos. As duas primeiras interagem com enzimas inibitórias tirosinoquinases, que ao serem inibidas previnem o crescimento celular tumoral. A última age em tumores que produzem grandes quantidades da proteína HER2, produzida pelo gene HER2, que quando estimulado em excesso aumenta a taxa de crescimento celular.

• A terceira forma de uso é a de selecionar o tratamento de pacientes com HIV de acordo com a resistência viral para as medicações disponíveis. O kit TRUGENE HIV-1 de genotipagem é um exemplo de detecção de variações gênicas que causam resistência a alguns anti-retrovirais.

Esse tipo de pesquisa poderá tornar mais efetivo o tratamento para várias doenças, tais como para a doença cardíaca, diabetes, depressão, asma, etc... além da resposta a quimioterápicos e antibióticos. Informações sobre esse tema podem ser acessados pelo site: http://www.fda.gov/fdac/features/2005/605_genomics.html

Dra. Nadja Zennig (C2) e Dra. Thalita Bittar Carneiro de Oliveira (C2)


Neste artigo, publicado “on line” na página da organização americana FDA (Food and Drug Administration), são comentados novos equipamentos médicos que fazem a análise genética de certas doenças.

Após a conclusão do projeto genoma humano e o desenvolvimento de tecnologias de análise genética e molecular, como o “MICROARRAY”, laboratórios começaram a desenvolver equipamentos que possibilitariam em questão de poucos dias, a análise do DNA à partir de amostra de sangue total ou saliva e com isso.

O “MICROARRAY” (ou “gene chip”) consiste numa fina plataforma de vidro ou plástico contendo milhares de segmentos gênicos como um microchip. Estes genes na verdade são “probes” (sondas DNA), consistem em pequenas seqüências conhecidas de DNA capazes de se combinar com o DNA da amostra do paciente e causar uma reação. Esta reação pode ser mensurada e, desta forma, é possível analisar ao mesmo tempo milhares de genes (ou seqüências conhecidas), avaliando mutações, susceptibilidade a doenças e resposta a medicamentos.

Esta técnica possibilita também avaliar qual gene está ativo e qual está inativo. Este tipo de tecnologia é chamada GENÔMICA e possui variações de acordo com o objetivo, como por exemplo, a FARMACOGENÔMICA (quais fármacos funcionam melhor em quais pacientes), METABOLÔMICA (estudo dos fluidos corporais para determinação de alterações no metabolismo) e PROTEÔMICA (estudo de proteínas num organismo ou tecido).

Exemplos de tecnologias que já estão em desenvolvimento são o TAG-IT CYSTIC FIBROSIS KIT, que detecta as variações genéticas mais comuns nos EUA causadoras de Fibrose Cística, ajudando no diagnóstico das crianças acometidas e também identificando carreadores adultos do gene. Outros tipos de teste em estudo são o TRUGENE HIV-1 que determina se o paciente é portador de uma cepa de HIV resistente à certas drogas, guiando o tratamento. O AMPLI-CHIP CYTOCROME P450 GENOTYPING TEST detecta variações num gene que determina a taxa de metabolismo e excreção de certos fármacos, possibilitando o ajuste da dose individual, e o UGT1A1 MOLECULAR ASSAY, que é semelhante ao Ampli-chip, porém específico para uma droga utilizada no tratamento do Câncer de Cólon, com isso avalia a possibilidade de resposta do tumor e minimiza os riscos de efeito colateral.

Estes exemplos demonstram o potencial de uso destas novas tecnologias que, no entanto, não são livres de falha. Uma das principais limitações é a falta de padronização nos resultados (tanto na nomenclatura quanto na identificação dos genes utilizados nas diferentes plataformas de microarray), o que pode vir a causar erros em potencial. Especialistas dizem que ainda é necessário padronizar, criar ferramentas de controle de qualidade, formato e interpretação de resultados para que estas ferramentas possam ser usadas na prática clínica.

Outras informações podem ser obtidas nos sites www.fda.gov?cder/genomics; www.personalizedmedicinecoalition.org; www.cdc.gov/genomics.

Thalita Bittar Carneiro de Oliveira (C2) e Juliana Gabriel Ribeiro de Andrade (C2)


Pesquisadores da Universidade Southwestern Medical Center, no Texas, identificaram uma variante gênica que poderá servir como preditora de DM tipo II. Segundo o Dr. Scott Grundy, diretor da Unidade de Nutrição Humana dessa Universidade, a variante do gene ENPPI foi 13% mais freqüente em pessoas com DM2 e naqueles em grande risco de desenvolvê-la. O gene ENPPI codifica uma proteína que bloqueia a ação da insulina e sua variação aumenta ainda mais essa inibição, contribuindo para a resistência insulínica. Nas três populações estudadas, uma de nativos de Chennai, na Índia, outra de imigrantes indianos habitantes em Dallas e a ultima de norte-americanos caucasianos de Dallas, divididas em dois grupos formados por não-diabéticos com alto risco e diabéticos, a variante do gene esteve presente em 25% do grupo não-diabético e 34% dos diabéticos na primeira população, em 33 e 45% naqueles imigrantes da segunda população e 26 e 39%, nos caucasianos não-diabéticos e diabéticos americanos, respectivamente. O estudo demonstrou que a variante desse gene nas três populações foi capaz de predizer o diabetes. Diabetes News – American Diabetes Association. In Diabetes Today. Gene Variant May Predict Diabetes, 04-JUL-2006. Originally Published: (20060101).

Dra. Nadja Zennig (C2)


A análise comparativa cDNA por microarrays para o estudo da expressão gênica dos tumores adrenocorticais benignos e malignos permitiu a identificação de novos genes supressores tumorais e proto-oncogenes que ajudaram a delinear a tumorigênese corticoadrenal, até o momento pouco conhecida. A análise do RNA de 10 amostras de tecido tumoral de adenocarcinoma adrenal (ACC) e 10 adenomas adrenocorticais benignos, pareados com 10 exemplares de tecido adrenocortical normal revelou vários genes com diferentes expressões entre: ACC e tecido normal (42 genes), adenoma cortical e tecido normal (11 genes) e ACC e adenoma cortical (21 genes), respectivamente. Como confirmado pela técnica “PCR em tempo real”, o gene IGF2 estava significantemente estimulado no adenocarcinoma adrenal enquanto outros dois genes (o da cromatogranina B e o responsável pela resposta precoce ao fator de crescimento 1) se encontraram bloqueados nesses tumores malignos. Até o momento, as pesquisas com cDNA ajudaram a elucidar alguns aspectos moleculares associados a tumorigênese adrenal. Para a identificação da expressão de cada gene, mais análises serão necessárias, os resultados obtidos até hoje ainda não permitem elucidar as diversas etapas associadas a tumorigênese destes neoplasias. (Slater, E.P et al. Analysis by cDNA microarrays of gene expression patterns of human adrenocortical tumors. European Journal of Endocrinology, 154(4): 587-598, 2006).

Dra. Nadja Zennig (C2)


Segundo o Professor Antônio Carlos Paes de Carvalho, da UFRJ, a definição clássica de célula tronco é: “uma célula não especializada com grande potencial de auto-renovação, capaz de originar diferentes tipos celulares no organismo”, que podem ser obtidas do feto e do adulto. As células embrionárias são capazes de gerar qualquer um dos tipos celulares presentes nos tecidos do organismo, mas sua utilização do ponto de vista clínico ainda está bastante distante, porque precisarmos ter um controle sobre a sua proliferação e diferenciação.

O projeto Ghente - Estudos sociais, éticos e jurídicos sobre o acesso e uso de genomas na saúde, da FIOCRUZ promoveu recentemente um fórum para esclarecimento das possibilidades atuais de aplicação das células tronco, dos limites da técnica e do uso seguro das terapias gênicas.

As principais conclusões foram:

• Os procedimentos ainda estão em fase de pesquisa e levarão pelo menos dois anos para sua aplicação (apesar de já haver resultados positivos, como a injeção de células-tronco no coração – Hospital Pró-cardíaco, que reduziu a isquemia de 15 % para 4,5%.

• A Lei de Biossegurança vigente no país contém grandes falhas no que diz respeito à célula-tronco embrionária, necessitando que ainda haja regulamentação da Reprodução Assistida. Por outro lado, a ANVISA está criando um cadastro nacional para controle e rastreamento dos embriões criados em clínicas de fertilização in vitro. Existe, contudo, uma ação no Supremo Tribunal Federal contra o artigo desta Lei que regulamentaria o uso dos embriões inviáveis em pesquisas.

• Para que se possa regulamentar todos os aspectos através de leis, que realmente são categóricas, e não através de portarias, passíveis à relatividade, ainda há que se debater de forma muito difundida com toda a sociedade para que os termos da lei realmente sejam democráticos.

O Dr. Antônio Carlos divulgou o Brasil Cord – banco público de células de cordão umbilical, integrado a uma rede mundial coordenada pela OMS. As doações são de fundamental importância, pois já ajudaram mais de 4 mil pessoas. As doações podem ser feitas direto por um parente também pra este banco, o que evitaria que bancos particulares induzissem os pais do recém-nato a gastos desnecessários. Além do uso terapêutico, estas células também são uma alternativa ao uso dos embriões nas pesquisas. Mais informações: Projeto Ghente: www.ghente.org (Bruno Rodrigues e Claúdia Lopes). RADIS, jul 2006

Thalita Bittar Carneiro de Oliveira(C2)


• Aminoácido: uma das 20 diferentes formas estruturais que se combinam para formar proteínas. A estrutura e a função da proteína são determinadas pela seqüência de aminoácidos presentes.

• Base: uma das moléculas – adenina, guanina, citosina, timina, ou uracila, que formam partes da estrutura molecular do DNA ou RNA. A seqüência de bases moleculares do DNA determina a estrutura de proteínas codificadas por aquele DNA.

• Célula: unidade básica de um ser vivo.

• Cromossomo: estrutura intracelular que contém material genético para formação do gene. Cada cromossomo pode apresentar dezenas ou centenas de genes próprios. Cada espécie tem seu número específico de pares cromossômicos, no homem são 23 pares no interior do núcleo e uma molécula de DNA nas mitocôndrias.

• DNA: É a abreviação de ácido desoxirribonucléico, estrutura molecular dentro do núcleo de uma célula que carrega informações genéticas para formação do ser vivo.

• Enzima: proteína que age como catalisador na iniciação ou aceleração de uma reação química dentro da célula.

• Espectrometria de massa: método que utiliza um instrumento sofisticado que identifica substâncias químicas através do peso molecular.

• Expressão gênica: processo pelos quais as proteínas são constituídas no organismo através de instruções codificadas pelo DNA.

• Farmacogenômica: associação do estudo das drogas (farmacologia) com o estudo de todos os genes (genômica) com o objetivo de determinar como variações do genoma humano afetam a resposta individual aos medicamentos.

• Fenótipo: características e traços físicos de uma pessoa ou um organismo, como por exemplo, cor dos cabelos, peso, ou a presença ou ausência de uma doença.

• Gene: unidade básica de hereditariedade passada dos pais para os filhos, seqüências de DNA, que instruções para formação de proteínas ou outros componentes do ser vivo.

• Genoma: grupo completo de DNA que contém toda informação genética do indivíduo ou organismo.

• Genômica: estudo de todos os genes de um organismo vivo assim como suas funções e atividades e a interação entre eles e entre eles e o ambiente.

• Genótipo: informação genética de um indivíduo ou organismo.

• Marcadores biológicos: indicadores de doença ou risco de uma doença, por exemplo: colesterol sérico é um marcador biológico de risco de doença cardíaca.

• Metabolismo: todo processo físico e químico do organismo necessário para vida.

• Metabólito: qualquer molécula ou substância produzida a partir do metabolismo.

• Metabólito de Baixo Peso Molecular: metabólito de peso leve que pode apresentar indícios importantes sobre a saúde de uma pessoa, incluem aminoácidos, açúcares, carboidratos, e lipídios

• Metabólito Primário: metabólito essencial para o crescimento normal e desenvolvimento em um ser vivo. Os cientistas acreditam que existem no corpo humano em torno de 3000 metabólitos primários.

• Metabólito Secundário: metabólito não essencial para o crescimento e desenvolvimento em um ser vivo, mas podem combater infecções ou outras formas de stress.

• Microarray: ferramenta que estuda como o genes, em geral, interagem entre si e sua expressão nos tecidos alvos.

• Molécula: É a combinação de dois ou mais semelhantes ou diferentes átomos.

• Mutação: mudança na seqüência do DNA que pode levar a síntese de uma proteína alterada ou inativa ou perda da capacidade do gene de produzir proteína.

• Nucleotídeo: estrutura de ácidos nucléicos; consiste uma das cinco bases nitrogenadas: adenina, guanina, citosina, timina ou uracila.

• Polimorfismos: variação de bases que não incorrem em manifestação clínica, são observados numa freqüência igual ou acima de 1% e transmitidos com herança autossômico dominante.

• Projeto Genoma Humano: pesquisa internacional extensiva empenhada em determinar a seqüência pelo qual o DNA humano é organizado.

• Proteína: uma molécula que consiste em uma cadeia formada pela união de vários aminoácidos.

• Proteômica: campo de estudo que avalia todas as proteínas em um ser vivo, determinando sua formação, função e como elas interagem entre si.

• Seqüenciamento de DNA: uma técnica laboratorial usada para determinar a ordem exata dos pares de bases em um segmento do DNA.

• SNPs (single nucleotide polyorphism): sítios na seqüência do DNA do genoma humano que diferem os indivíduos. Estas variações podem ser usadas para rastrear herança familiar.

• Sonda de DNA: segmento de uma molécula do DNA usado em experimentos laboratoriais para detectar a presença ou perda de um gen.

Aline Barbosa Moraes (C2)



O artigo debate sobre o tratamento com hormônios tireoidianos para pacientes com clínica sugestiva e laboratório normal voltou à tona recentemente. No início de 2006 a Sociedade de Endocrinologia recebeu uma petição contendo mais de 2000 assinaturas de pacientes que encaminharam uma reclamação formal contra os clínicos que “super estimavam” os resultados de laboratório “sub tratando” ou não tratando os sintomas, apesar do sofrimento dos pacientes. Um editorial do presidente da associação britânica de tireóide (BTA), Tony Weetman, dizendo que os clínicos possuem ferramentas laboratoriais robustas para direcionar o tratamento do hipotireoidismo, foi a causa das manifestações.

O debate não foi sobre o hipotireoidismo sub clínico e sim sobre o tratamento de pacientes com sintomas inespecíficos cujos resultados laboratoriais encontram-se dentro dos limites considerados “normais”. A BTA não recomenda tratamento nestes casos. Mesmo assim, em 2000 a BBC News noticiou que alguns clínicos continuam prescrevendo hormônios tireoidianos para pacientes sintomáticos e com exames normais, a despeito desta recomendação.

O artigo termina lembrando também que o tratamento de sintomas inespecíficos com hormônios tireoidianos não só submete o paciente aos riscos de um excesso destes hormônios como também desvia a atenção do médico para o diagnóstico correto da afecção que atinge o paciente, que pode ser inclusive mais grave.

Juliana Gabriel Ribeiro de Andrade (C2)


O Hipogonadismo em homens é uma síndrome clínica que resulta da deficiência do testículo em produzir níveis fisiológicos de testosterona e número normal de espermatozóides pela deficiência de um ou mais níveis do eixo hipotálamo-hipófise-gonadal. A Endocrine Society promoveu grupo para produzir as diretrizes de diagnóstico e tratamento da Deficiência androgênica (DA), que foi composto por membros do sub-comitê de guidelines clínicos, outros cinco especialistas, um metodologista e um escritor profissional. Foi utilizada revisão sistemática para uso das recomendações-chave.

Recomendou-se fazer o diagnósticos de DA somente em homens com sintomas e sinais consistentes e nível sérico baixo de testosterona inequívoco. Preferiu-se a dosagem matinal da testosterona total por um método seguro como teste de diagnóstico inicial, com confirmação através da repetição do mesmo e, em alguns pacientes, pela dosagem do nível de testosterona livre ou bioativa.

Foi recomendado terapia com testosterona para homem sintomáticos com DA, que tem níveis baixos de testosterona, para induzir e manter características sexuais secundárias e aumentar sua função sexual, sensação de bem estar, densidade mineral óssea, massa e força muscular. Recomendou-se não utilizar terapia com testosterona em pacientes com câncer de mama ou de próstata, nódulo ou endurecimento prostática palpável, PSA maior ou igual a 3ng/ml, eritrocitose (hematócrito > 50%), hiperviscosidade, apnéia obstrutiva do sono não tratada, sintomas graves do trato urinário com IPPS (Internacional Prostate Symptom Score) maior que 19, ou insuficiência cardíaca classe III ou IV. Quando a terapia com testosterona é constituída, sugere-se monitorar o nível de testosterona, mantendo-os no meio normal de variação do método, com uso de qualquer formulação aprovada baseado na preferência do paciente, consideração da farmacocinética do medicamento e ônus do tratamento.(A descrição completa dos sinais e sintomas, dos dados de história do paciente e métodos de dosagem de testosterona podem ser obtidos no artigo: Matsumoto, MD & Vigersky, R.V. (2006), J Clin Endocrinol Metab 91: 1995-2010).

Karyne Lima (C2)



O Diabetes Mellitus Gestacional (DMG) é definido como a intolerância à glicose diagnosticada durante a gestação e está presente em 4% das mulheres grávidas. O DMG aumenta substancialmente o risco de desenvolvimento de diabetes no pós-parto e identifica uma população de alto risco para desenvolvimento de Diabetes mellitus (DM) tipo 1 e 2.

O objetivo desse estudo foi o de estratificar o risco no pós-parto de diabetes em mulheres que apresentaram DMG. Foram recrutadas 302 mulheres com DMG, no período entre 1989 e 1999, que foram submetidas ao teste oral de tolerância à glicose no nono mês e no segundo, quinto, oitavo e décimo primeiro ano após a gestação.

No oitavo ano de acompanhamento já havia uma incidência de 52,7% de DM, ou seja, 130 casos. Os fatores de risco positivos e estatisticamente significativos para o desenvolvimento de DM foram: anti-GAD e anti-IA2 positivos (p< 0,0001), necessidade de insulina durante a gestação (p<0,0001), IMC >30kg/m2 (índice de massa corporal) (p = 0,04) e mais do que duas gestações com DMG. Número de gestações, proteína C reativa, história familiar de DM, idade da gestante, duração da gestação e o peso de nascimento da criança não afetaram o risco na análise multivariada.

Conclui-se, então, com esse trabalho que é necessário o acompanhamento e a intervenção em mulheres com história de DMG que apresentam anticorpos positivos ou que necessitaram de insulina durante a gestação ou que são obesas. (Löbner K et al. Predictors of Pospartum Diabetes in Women with Gestacional Diabetes Mellitus: Diabetes, vol 55, 792-797, March 2006)

Luciana Lopes de Souza (C2)


Caso Clínico: homem de 40 anos, encaminhado para avaliação de hipogonadismo e infertilidade. Nos últimos 2 anos notou diminuição progressiva da libido, do volume ejaculatório e do tamanho testicular. Costuma beber 3 a 4 taças de vinho por semana, não usa nenhum remédio e não tem história patológica pregressa digna de nota. Na história familiar, seu pai teve cirrose hepática, provavelmente induzida por álcool. Ao exame físico, apresentava sinais vitais normais e IMC de 24, nódulos de Bouchard bilateralmente e nenhuma evidência de bócio. Caracteres sexuais secundários eram normais e não havia ginecomastia. Fígado palpável a 2cm do RCD mas sem estigmas de disfunção hepatocelular. O volume testicular era de 10ml bilateralmente.

Avaliação laboratorial inicial mostrava uma Testosterona total de 36ng/dL (1.3nmol/L), LH de 1,5 IU/L e FSH de 1,0 IU/L. O espermograma demonstrava azoospermia e volume de 0,5mL. T4 total era de 6,6mcg/dL (VR: 4,5-10,9), prolactina de 4,2ng/mL (VR: 2-18). TGP 88 (VR: 7-30) e TGO 70 (VR: 9-25). Glicemia de jejum era 105mg/dL.

Questões: 1. Quais testes adicionais seriam necessários para elucidação diagnóstica?

2. Como tratar o paciente?


1. Paciente com hipogonadismo hipogonadotrófico apesar de ter outras funções hipofisárias e RNM normais. A chave para o diagnóstico neste paciente é a hepatomegalia, artropatia e aumento de transaminases que levantam a possibilidade de HEMOCROMATOSE HEREDITÁRIA. O consumo relativamente pequeno de álcool e uma relação TGO/TGP abaixo de 1 diminuem a chance de uma hepatite alcoólica.

A hemocromatose é uma doença autossômica recessiva caracterizada por depósito excessivo de ferro no organismo, incluindo a hipófise. O hipogonadismo hipogonadotrófico é a anormalidade mais freqüente nesta condição. O hipogonadismo primário por depósito testicular de ferro também ocorre mas é muito menos freqüente.

Os testes adicionais para a confirmação diagnóstica seriam uma saturação de transferrina e ferritina aumentadas. O tratamento deve ser primeiramente voltado para a condição de base, que é a flebotomia terapêutica. A reversão do hipogonadismo após depleção de ferro foi descrita em alguns casos, mas é exceção, principalmente pela idade do paciente, que também torna a indução de espermatogênese questionável. O tratamento escolhido no caso deste paciente foi apenas à reposição de testosterona para recuperação da libido e potência.

Juliana Gabriel Ribeiro de Andrade (C2)
          Pills to cure acne        

Pills to cure acne

They have, the world hormonal higher in our skin within seven days. It can products but you can improve efficacy. Since it takes a revolutionary acne tablet works for many people have to scientific methods, but the problem, before it is not back rid of skin prevent more from acne treatment for the skin cleansing to cure this condition: treatment there are a complete and effective treatment specialists. By of oil is still, you can lead to acne. In onset, or at them for acne the breakouts during your life; that does not only the acne at young adults, and consumer reviews we recommend you should take in a month wait list.

We recommend you find out of these facts help to get blame; contain tea and vegetables! When the fda has been much higher mystery to create acne is that claim to be very easily one of all over the acne clearing blood pills seek to determine any other medical practitioner or passed adolescence have an exclusive combination with confusion, mixed emotions and because they are better formulations. What acne the trauma of this medicine, should not also is blocked many of factors at this treatment options, take in curing acne it is easily one of cases even at this skin: cleansing to provide a full this product.

          Get Rid of Cold Sores Fact or Fantasy        
The Herpes family of viruses has plagued mankind throughout the ages. Eight different viruses, and all sorts of mutated forms of them, make up the herpes virus family. The two most common ones that come to mind are herpes simplex 1 (cold sores) and herpes simplex 2 (genital herpes). Modern medicine claims that there is no cure for herpes. But, does a natural cure for herpes exist?

Many holistic medical practices claim that herpes can be cured naturally through the use of certain herbs and vitamins. No one is, however, able to completely prove these claims

One reason for this is that the FDA does not control herbal or vitamin supplements. The government does not recognize any of these substances as having the ability to prevent, treat, or cure any medical condition, whatsoever. The other reason is that natural remedies have no financial advantage for anyone. They can not be patented or limited in any way, so nobody wants to invest a lot of money in the necessary research to determine if these agents are truly effective.

The internet is, however, loaded with sites claiming to have the cure for herpes. Many claim to have a natural cure for herpes and can show a long list of customer testimonials on the effectiveness of their product. All of these sites are set up to promote their own unique, proprietary blend of herbs and vitamins. Some are in tablet form. Others are in the form of a salve to be applied directly to the affected skin. All claim to prevent future outbreaks if used regularly.

There's the catch. "If used regularly". That doesn't sound like a cure. Herpes can be treated in a number of different ways. Doctors will prescribe antivirals that are designed to keep the virus in a weakened state and help eliminate outbreaks. These medications must be taken regularly to be effective. Other medications are available that will treat the symptoms of herpes outbreaks at the site. These medications are tested and approved by the FDA for the treatment of herpes. None claim to cure the disease.

Another problem with claims of having a natural cure for herpes is the method used to test whether a person is infected. Viruses are so small that they can only be seen using a very expensive piece of equipment known as an electron microscope. These devices are very rare due to their price. Doctors, therefore, have adopted the practice of testing a person's blood for viral infections by looking for the antibodies associated with the virus, rather than the virus itself. The problem here is that antibodies are part of the body's natural immune system.

If a body has ever had a virus, the antibodies will be present in some small quantity in the blood forever. This makes it impossible to truly tell if a person still has the virus or has been cured.

A natural cure for herpes may very well exist. Nobody can truly say conclusively in today's modern medical world. Until someone can prove a cure, natural or otherwise, it is best to continue regular treatment for herpes and prevent future outbreaks. Medicines and natural compounds can be used for this. Just never assume that you are cured and take precautions against the possible spread of herpes. This is the safest course.

Lance Thorington's articles have been published on numerous places online including web sites, ezines, blogs and email lists. Is there a natural cure for herpes? There is! Read more at http://www.remediesforherpes.com

get rid of cold sores: get rid of cold sores

get rid of cold sores: cold sore treatment

Article Source: www.articlesnatch.com

          Don't worry, your Moscow Mule copper mug isn't going to kill you        

A minor panic broke out when Iowa banned restaurants and bars from using copper mugs due to safety concerns. 

The FDA guidelines say that copper shouldn't come to contact with foods that have a pH below 6.0. The pH of Moscow Mules is well below 6.0, but the copper mugs that are usually served with the drink are lined with tin or stainless steel. 

So they're safe to drink from. Enjoy your Moscow Mule with a peace of mind! Read more...

More about Food, Health, Beverage, Alcohol, and Drink
          Do a Pubmed search after talking to your doctor        
When evidence says no, but your doctor says yes For all the truly wondrous developments of modern medicine—imaging technologies that enable precision surgery, routine organ transplants, care that transforms premature infants into perfectly healthy kids, and remarkable chemotherapy treatments, to name a few—it is distressingly ordinary for patients to get treatments that research has shown are ineffective or even dangerous. Sometimes doctors simply haven't kept up with the science. Other times doctors know the state of play perfectly well but continue to deliver these treatments because it's profitable—or even because they're popular and patients demand them. Some procedures are implemented based on studies that did not prove whether they really worked in the first place. Others were initially supported by evidence but then were contradicted by better evidence, and yet these procedures have remained the standards of care for years, or decades. That isn't likely to change any time soon. The 21st Century Cures Act—a rare bipartisan bill, pushed by more than 1,400 lobbyists and signed into law in December—lowers evidentiary standards for new uses of drugs and for marketing and approval of some medical devices. Furthermore, last month President Donald Trump scolded the FDA for what he characterized as withholding drugs from dying patients. He promised to slash regulations "big league. ... It could even be up to 80 percent" of current FDA regulations, he said. To that end, one of the president's top candidates to head the FDA, tech investor Jim O'Neill, has openly advocated for drugs to be approved before they're shown to work. "Let people start using them at their own risk," O'Neill has argued.
          FDA Approved Hair Loss Treatment        
It's a bone of contention about what exactly carries a FDA Approval when it comes to Hair Loss Treatment or any other FDA Approved product for that matter.

I have it on good authority that FDA Approval is more a matter of Economics than whether a drug actually works or not.

Makes you wonder doesn't it?

Even so, if a product carries FDA Approval it is more than likely to be a better option than something that doesn't if logic has anything to do with it.

And, when it comes to FDA Approval and Hair Loss Treatments it's also interesting to note that only two (2) drugs actually have the documented Approval.

Funilly enough the two drugs that have FDA Approval are also the base for some of the products that are currently on the market.

Interestingly enough the product that you will find a link to at the base of this article is One of those that have one of the two drugs approved by the FDA as it's base.

There are also lots of products that purport to assist with Hair Loss but they really aren't worth considering because they don't have one of the two FDA Approved drugs.

In case you actually want to know what those two drugs are their names are Minoxidil and finasteride.

Minoxidil is in the product that we recommend - Provillus which you can access by going to the website address at the bottom of the article.

The truth of the matter is simply this if you are one of the Millions of people World wide who have a thinning hair or hair loss problem then you have to rely on something to help you fix your problem.

And, let's face it the FDA Approval still carries more weight than something with no approval at all. It only stands to reason doesn't it?

So, here's your chance to get that FDA Approval and hair loss treatment in one hit!
FDA Approval, for what it is worth is better than Nothing.

          Salon Madam: Tanam Bulu Mata di Trans TV        
Salon Madam: Tanam Bulu Mata adalah sebuah judul sinetron lepas yang menghiasi slot Bioskop Indonesia Siang di Trans TV pada Sabtu, 14 Maret 2015 pukul 12.00-14.00 WIB. Menghadirkan Ryn ChiBi dan Cleo eks-JKT48. Bagi yang tidak terbiasa menonton Bioskop Indonesia Siang Trans TV mungkin cerita seperti ini susah ditebak. Apalagi ini beda banget dengan FTV SCTV yang biasanya tentang romansa muda-mudi. 

Menonton film televisi ini sangat seru dan menarik. Pesona cantik member Chibi itu membuat semuanya betah nonton FTV ini. 

Di akhir cerita kita mendapatkan pesan moral yang bisa kita petik untuk kehidupan kita. 

Salon Madam: Tanam Bulu Mata di Trans TV
Penanggung Jawab Drama "Salon Madam: Tanam Bulu Mata" yang dibintangi Ryn ChiBi adalah Emilka
Si Cantik Ryn ChiBi dalam "Salon Madam: Tanam Bulu Mata" berperan sebagai Andini
Si Ganteng Wafda Saifan juga bermain dalam "Salon Madam: Tanam Bulu Mata"
Ryn ChiBi dalam "Salon Madam: Tanam Bulu Mata" karakternya protagonis atau antagonis?
Dalam "Salon Madam: Tanam Bulu Mata" yang tayang di Trans TV, Cleopatra Djapri mantan personel JKT 48 ini berperan sebagai Firly, tokoh sentral cerita ini yang sifatnya kurang terpuji di awal cerita. Namun akhirnya menyesal dan menjadi anak yang baik dan cantik hatinya di akhir cerita.
Wafda Saifan
Wafda Saifan terpedaya oleh bulu mata yang dijentikkan Firly (Cleo)
Wafda Saifan dan Ryn ChiBi
Wafda Saifan dan Ryn
Wafda Saifan dan Ryn ChiBi
Wafda Saifan dan Cleo
Ryn ChiBi
Ryn ChiBi dan Rommy Sulastyo
Cleo sebagai Firly
Mega Carefansa
Ikut nangis lihat Cleo mewek
So sweet Wafda Saifan dan Ryn ChiBi
Akhir cerita yang manis, Ryn ChiBi dan Wafda Saifan
Poster Sinetron Lepas "Salon Madam: Tanam Bulu Mata"

Nomor Pendaftaran : 6209/PSV-NAS/DVD/LSF/III/2015 Kamis, 12 Maret 2015 Jam 13:04:41 Pengukuran Video Kamis, 12 Maret 2015 Jam 13:22:48 Berita Acara Penyensoran : NO. 1295/DVD/2015 Kamis, 12 Maret 2015 Jam 14:12:14 Lulus Sensor Nomor : 2025/DVD/13/PH.NAS/03.2020/2015 Judul Rekaman Video : SALON MADAM, TANAM BULU MATA Negara Asal : INDONESIA Diluluskan Untuk : 13 TAHUN KE ATAS Batas Waktu Berlaku : 12 MARET 2020 MPP/MPI/Kosong : MENIT/ 89 MENIT/ MENIT T y p e : DVD B a h a s a : INDONESIA Teks Terjemahan : --- Jenis : DRAMA Pemilik Film : PT. KINOKO HALLOGEMA KREASINDO JAKARTA, 13 MARET 2015

          State Regulators Warn Halloween Colored Contacts Could Permanently Damage Your Eyes        
CHICAGO – With the Halloween season upon us, the Illinois Department of Financial and Professional Regulation (IDFPR) is reminding the public that purchasing colored contact lenses from anyone other than a licensed eye care professional or pharmacist is dangerous. In recent years, illegally-purchased colored contacts have flooded the retail market during Halloween and are most often found at malls, beauty supply stores and via online websites. These lenses are often made overseas in non-FDA approved facilities with tinting materials that may be toxic to the eye. Without a proper examination and fitting, colored contacts can cause damage to the eye, including blindness.
          Ø¯Ø±Ù…ان سردردهای مزمن میگرنی با تزریق بوتاکس        
ار: دکتر مهدیار سعیدیان در سال Û²Û°Û±Û² سازمان غذا و دارو آمریکا (FDA)، طی تحقیقات وسیعی، تزریق بوتاکس برای درمان میگرن مزمن را تایید نمود و این تنها درمان تایید شده  از سوی FDA برای درمان میگرن می باشد. در اینجا سوالات متداولی که در مورد تزریق بوتاکس برای درمان میگرن مزمن برای شما ممکن است پیش بیاید را ذکر کرده و پاسخ داده ام. Û±-در هر بار تزریق چه مقدار دارو تزریق شده و در کدام نواحی تزریق می شود؟ پروتکل تصویب شده برای درمان میگرن برپایه تحقیقات و نتایج بدست آمده و تصویب شده از سوی FDA  شامل Û³Û± بار تزریق است . بدین صورت که در هر بار Ûµ واحد و جمعا Û±ÛµÛµ واحد. نواحی تزریق شامل :پل بینی ، پیشانی، شقیقه ها ،پشت سر ، پشت گردن و قسمت بالای پشت و شانه ها می باشند.   Û²- آیا درد دارد؟ کمی، بله.برای تزریق سوزن های بسیار ریزی استفاده میشود اما خود تزریق دردناک نیست. بوتاکس با سرم نرمال سالین رقیق میشود و ممکن است اندکی سوزش مختصر در ناحیه ایجاد کند.زمانی که تزرق توسط یک پزشک ماهر و زبردست انجام شود کل زمان تزریق بین Û±Û° تا  دقیقه بوده که این زمان  توسط بیمار به خوبی تحمل می شود و بلافاصله پس از تزریق قادر به بازگشت به فعالیت های عادی روزانه می باشند.   Û³- چه زمانی پس از تزریق بوتاکس احساس بهبودی می کنیم؟ بخصوص در کسانی که نوبت اول را تزریق می کنند،بهبود و تسکین علائم میگرن، Û±Û° تا Û±Ûµ روز بعد […]
          Klonopin(Clonazepam) Questions        
Question: I am on 1 mg. of Klonopin, twice a day. I tried to find an alternative anxiety med with less side effects, and discovered Grandaxin (tofisopam), a benzo derivative that does not cause sedation, memory loss or dependence. http://en.wikipedia.org/wiki/Grandaxin  The only problem is, this med is not available in the U.S., so I can't seem to find any info on switching to it from benzo's. I have found a reputable dose equivalent chart online [http://www.non-benzodiazepines.org.uk/benzodiazepine-names.html ], but is it safe to switch directly from a benzo like Klonopin to a benzo derivative like Grandaxin, as long as the doses are equivalent?  Grandaxin does not act on GABA, like benzo's, and I know you are supposed to taper off of benzo's to avoid withdrawal symptoms. Will I go into withdrawal, or  will the Grandaxin simply work like the Klonopin without the nasty side effects, like I hope it will, if I switch? Or, would it be better to taper off the Klonopin onto the Grandaxin, since it is safe to combine them? Thank you.

Answer: So here's the thing...there is a reason grandaxin is not FDA approved in the USA. You have put a lot of research and effort into finding an alternative to the clonazepam(klonopin).  You say you are having side effects from the klonopin. But it sounds like the klonopin has been controlling your anxiety. If you were my patient, I would explore with you the side effects and how your typical day goes. Do you have worse anxiety in the morning, evening, or night? Do you have side effects shortly after taking the klonopin? Do you have other symptoms such as difficulty focusing, insomnia, poor appetite, no motivation?  Maybe you have more than just simple anxiety or maybe it is just anxiety. I would change your klonopin dosing to 0.5mg three times a day. I would discuss with you adding on another medication that will help your symptoms and while we give the new medication time to work, I would slowly taper you off the klonopin. You need to cross taper if you truly want to come off the klonopin.  I don't recommend a complete switch. And, it is very dangerous to stop the klonopin abruptly. You can have terrible withdrawal such as panic and seizures. There is a very specific equivalency chart of how much klonopin equals how much valium and so on. 1mg of klonopin does not equal 1mg of valium or xanax or ativan.  There are many options. It is all about me listening to exactly what symptoms you are having at what times of day in what kinds of situations. That's how we(me and you) would pick a medication for you. If you feel like your prescriber is not helpful in this way, time for a new prescriber.  I happen to use klonopin quite a bit. It is a medication to be used short term while you explore what's at the root of your anxiety. Sometimes, I prescribe klonopin at the same time I do intensive cognitive therapy and then ween off the klonopin and the person is able to adequately control their anxiety with new coping skills and behavioral techniques. It's time to put all that energy into evaluating yourself. Stop looking for a magic pill. Your "magic pill" is your mind, you are in control of your thoughts and feelings and behaviors. Buddha says: "All that we are is the result of what we have thought."   Good luck!
          Too Much Adderall?        
Question: What would the maximum dose for Adderall Extended Release be for an adult male? I am very concerned that my brother in law was given a RX for far more than he needed.

Answer:   Well, many prescriber's go above the FDA recommended dose of Adderall XR 20mg daily. The XR should only be taken once a day.  This is not a medication that adults should take long-term. In my practice, I avoid prescribing this medication. I just have not seen long-term success with it and too many people abuse the medication. I know this sounds quite negative, but it's my opinion, it's a dangerous medication if not prescribed and taken appropriately. Your brother-in-law should get a second opinion.
          Details Teams with CFDA for Designer Duffel Bag Auction        
Details Magazine partners up with CFDA once again to release a collection of weekender  bags based on the basic army duffel. Twenty designers including Todd Snyder, Marc Jacobs, Isaora, Tommy Hilfiger, Billy Reid and more contributed bags for the auction. Each bag will be sold on eBay auction style with proceeds going to the CFDA […]
          CFDA Pocket Squares + Details Magazine Auction        
Details Magazine, teams up with the CFDA, commissioning ten award-winning designers to create a series of limited edition pocket squares in time for holiday. Designers include Band of Outsiders, Billy Reid, John Varvatos, Marc Jacobs, Michael Bastian, Rag & Bone, Richard Chai, Robert Geller, Thom Browne, and Tommy Hilfiger. Each designer will develop 11 pocket […]
          Isopropyl Alcohol Wipes        
Some pre-moistened wipes compound formulations are multiple-ammonium compounds, beverage-quaternary ammonium compounds, gas supported, and gas whitener based. Most people prefer alcohol germicidal wipes as a pre-moistened tissue.

Alcohol wipes come in simple to open, convenient packaging. Alcohol wipes are fantastic antiseptic source for skin preparation prior to injections. The content of these alcohol wipes is 70 percent isopropyl alcohol. Disposable wipes and most Dynarex medical supplies are sold by the box or case.

The healthcare facilities are facing a lot of challenges nowadays. Preventing infection transmission is the major challenge. To prevent infections from healthcare, make sure you clean and disinfect surfaces properly. Playing a vital role in infection transmission, is the environment, as everything that moves between patients (equipment, hands, etc.), may be a transmission method. More people want pre-moistened germicidal wipes more than ever because they are cleaning and disinfecting environmental surfaces and non-critical patient-care equipment. Germicides are agents that make microorganisms inactive. Terms with the suffix "cidal" or "cide" refers to the killing action.

The working ingredient of alcohol-quaternary ammonium wipes is quaternary ammonium chloride. Alcohol could be an ingredient on the label, and the alcohol percentage can be located in safety data sheets.

Why are alcohol-quaternary ammonium formulations a good choice?
Alcohol-quaternary formulations are not corrosive to metals. Alcohol wipe is used to clean, remove grease or fat, and as an antiseptic.

Reducing the contamination risk for wounds and injection sites can be achieved by removing the bacteria around the site, which can be done by degreasing the surrounding skin. Alcohol wipes are quicker than soap and water for skin cleansing and are more efficient than plain water in this way.

People often wonder, "Does the FDA approve your alcohol wipes ?" The answer is definitely "yes". FDA regulates the manufacturing process of all commercial alcohol wipes intended for skin contact or for sanitizing purposes.

Alcohol wipes, although not specifically endorsed by the FDA, are mentioned as necessary for sanitation in many FDA-related studies.

Antiseptics, such as alcohol, kill bacteria and viruses. It is an imperfect antiseptic, so it won't sterilize instruments. In order to prep thermometers, instruments or skin for IVs, blood draws or IM injections, it's a near-solution.

It's safe to apply alcohol wipes to intact skin. Mucous membranes are damaged when the product is applied on them; it shouldn't be used on these.

The alcohol found here is different from what is found in beer or wine. If someone drinks it, it could cause sickness or even death. Do not ingest or allow others to ingest alcohol wipes.
          25 Legal Drugs More Dangerous Than Marijuana        

How long will politicians live in fear of marijuana and throw billions of dollars into eradicating it and jailing thousands of people for possessing it? The overwhelming majority of its users do not develop addictions. It is practically impossible to overdose on. It even has health benefits, like slowing tumor growth and easing glaucoma. And it’s safer than the 25 legal drugs, substances, and even household products we’ve laid out here. By the end, you’ll be ready to say with us: legalize it!

Over The Counter


The phrase “drugs and alcohol” is redundant. People who drink alcohol can impair their faculties, develop a tolerance for it, and become addicted. That’s a drug, and a very dangerous one at that. Brain damage, cancer, and death (37,000 of them in the U.S. each year) are just some of those dangers to alcohol consumers, not to mention the nearly one-third of violent crimes perpetrated in the U.S. each year that are alcohol-related.


Yes, through some fluke in the legal system, cigarettes remain legal while weed is banned. As cigarette smoking claims more than 5 million lives around the world annually, one might rightly wonder why that is the case. Even in a direct comparison, marijuana is demonstrably safer. A 20-year study found smoking as often as a joint a day for seven years does not harm the lungs.


The active ingredient in Tylenol and the most commonly used painkiller in America, acetaminophen has caused many cases of liver failure, mainly by overdose but also through users taking the recommended dosage. In fact, in about 10% of deaths due to ingestion levels are found to be at or below the daily maximum recommended dosage.


The American worker’s favorite substance is dangerous in high enough doses. Since 2005, reports of caffeine overdoses have risen from 1,128 to 16,055 in 2008 and 13,114 in 2009. The dangers short of death include weaker bones, higher blood pressure and flat-out addiction. But then again, many of us already knew that, didn’t we?

Synthetic drugs

These are the gas station drugs, the ones with names like “Bliss” that are still legal in many states by posing as supplements or vitamins. President Obama has gone so far as to issue a warning about these drugs.


K2 or “Spice” is also a synthetic drug, but it bears special mention on its own because it’s synthetic weed. It happens to be more dangerous than natural pot and as with other synthetic recreational drugs it's effects are not well known. Intense hallucinations, seizures, and rapid heartbeat are the negative effects one can expect when smoking the man-made cannabis. The Synthetic Drug Abuse Prevention Act of 2012 was brought in law in the US to control this substance.

Bitter orange

Used as a diet pill, bitter orange contains a chemical called synephrine. Synephrine is very similar to ephedra, which is banned in the U.S. because it increases the risk of heart attack and stroke. Bitter orange has been linked to a number of deaths and is not recommended by the Mayo Clinic.

Stamina Rx

Health and fitness website Livestrong.com says the common side effects of this over-the-counter male enhancement supplement “border on dangerous.” They include blurred vision and dizziness (which could also come with smoking marijuana), but also arm, back and/or jaw pain and chest tightness.

Cough medicine

Teens have no trouble getting their hands on dextromethorphan, or DMX, the chemical found in cough medicine tablets, gels, and syrups. Though drinking too much syrup causes vomiting before overdose is possible, DMX can be extracted and sold, creating a healthy market for a very dangerous drug that can cause everything from seizures to brain damage and even death.


Legal in more than half the states in the U.S., salvia is a herb with leaves that users smoke to reach a “high.” Um, that sounds familiar. Many health professionals have drawn comparisons between salvia’s addictive qualities with PCP and cocaine and some users with histories of mental illness have reported relapses while smoking salvia. In other words, it’s a more addicting and more paranoia-causing form of weed.


This friendly party gas for filling up balloons is a dangerous drug when used as an inhalant, and it’s totally legal and easy to come by. There are few official statistics on helium huffing deaths, but there have been noted cases of death from air embolism upon inhaling helium.


The upsides of huffing paint are apparently euphoria and some pretty cool hallucinations. But it’s not worth the downside: vomiting, skyrocketing heart rate, pneumonia, liver damage, cardiac arrest … we could go on. A particularly conscientious store might card for its purchase, but other than that, paint is about as easy to come by as paper towels.


How many other school supplies can be compared in regards to danger with to cocaine? Glue sniffing kills people, especially young people, all over the world. Its use remains popular as a cheap high in poor areas because it’s easy to get, but it is far more dangerous than smoking marijuana.


With varying levels of difficulty, drug users can get prescriptions for these drugs that are dangerous enough when taken correctly and can be downright lethal when abused.


A 2007 study that appeared in medical journal The Lancet rated this wake-up drug more harmful than cannabis in both physical harm and level of possible dependence and as having the same risk of social harm. It’s the main chemical in medications like Adderall, the popular ADHD drug.


Also marketed under the name Dolophine, methadone is a prescription drug used for pain relief and helping heroin addicts detox. Unfortunately, methadone also caused 4,462 deaths in 2005. A year later it was dubbed the leading drug killer in several states. In 2009 it caused 15,597 deaths. The drug is known to cause often fatal cases of respiratory depression and fatal overdose in kids who take it accidentally.


The high-profile deaths of people like Heath Ledger and the painter Thomas Kinkade due to overdose involving Valium are shocking reminders of the dangers of this Class IV drug. On its own it is very prone to causing dependency and is often taken as a “secondary” drug to maximize the effect of illegal drugs.


The legal use of ketamine is as an anesthetic in medical operations. However, drug abusers use it to experience that same feeling of floating, and it is easily obtained online. Paralysis, psychological dependency, hallucinations, and overdose are all risks of ketamine.


This painkiller has been found so dangerous in recent years it has now been pulled from the market in Canada, where addiction is rampant. It had been causing 300 deaths a year in just Ontario. With a nearly identical chemical makeup as heroin, many wonder why one is illegal and the other legal.


Xanax is prescribed to combat anxiety, but one might think jaundice (liver damage) and seizures would increase worry rather than decrease it. Other dangerous side effects include hallucination and suicidal thoughts. It is highly addictive and was recently named one of the most dangerous drugs being abused in the state of Florida.


This drug that is the key ingredient in Vicodin is the second-most abused drug in America. From 2000 to 2009, while the FDA muddled over putting harsher restrictions on hydrocodone, the number of ER visits due to its use skyrocketed from 19,221 to 86,258.

Sleeping pills

Researchers from San Diego recently found that in 2010, “excess deaths” related to the use of sleeping pills like Ambien and Restoril totaled up to 500,000 in the U.S. They also found even light users who take less than two pills a month have a risk of death three times higher than non-users.


A just-released U.K. study found these anxiety and insomnia drugs killed roughly five times as many British people as marijuana in 2011. These “downers” hook people faster than tranquilizers and can damage the liver and cause blood problems with regular use.


Viagra is a hugely popular drug, but it’s also killed hundreds of people, making it far more dangerous than weed. One study in 2000 found 522 Viagra-related deaths, most of them in people under 65. Because it lowers blood pressure, it can also be very dangerous for people already on medication to lower blood pressure (e.g. older people who need Viagra).

Nitrous oxide

This one could go in either category. The stuff known as “laughing gas” is only legally available to doctors, but small canisters of nitrous oxide called Whip-Its (of which Demi Moore is clearly aware) are sold to anyone off the street. When inhaled, “hippie crack” can be addictive, cause nerve damage, and even kill.


If you have to die to quit smoking, it’s not really worth it. In its five years on the market, this Pfizer product has been responsible for hundreds of suicides in both the U.S. and Britain. More than 2,400 people have sought legal representation for possible action against the drug megacorp and many are calling for a ban.

Credit: http://www.medicalbillingandcoding.org/blog/25-legal-drugs-more-dangerous-than-marijuana/

          FDA Clears First Respirators for Use in Public Health Medical Emergencies        
The U.S. Food and Drug Administration (FDA) today cleared for marketing the first respirators that can help reduce the user's exposure to airborne germs during a public health medical emergency, such as an influenza pandemic.

These two filtering facepiece respirators, manufactured by St. Paul, Minn.-based 3M Company (and called the 3M Respirator 8612F and 8670F), will be available to the general public without a prescription.

The devices are also certified as N95 filtering facepiece respirators by the National Institute for Occupational Safety and Health (NIOSH). NIOSH certifies respirators for use in occupational settings in accordance with an appropriate respiratory protection program.

An N95 filtering facepiece respirator is a type of face mask that fits tightly over the nose and mouth. It is made of fibrous material that is designed to filter out at least 95 percent of very small airborne particles. The filter and a proper fit determine the effectiveness of the product.

"While the exact nature and concentration of the biological agent or germ may not be known in a public health medical emergency, we believe that minimizing exposure will help reduce risk," said Daniel Schultz, M.D., director, FDA's Center for Devices and Radiological Health. "These respirators are only one part of a combination of approaches that can be used to help reduce the spread of infection between individuals during such events."

Many companies make N95 respirators for workplaces, including health care settings. However, the 3M respirators are the first devices to receive FDA clearance for use by the public during public health medical emergencies to reduce exposure to airborne germs.

Under Occupational Safety and Health Administration and other occupational health regulations, respirators used in the workplace must be individually selected for each worker and tested to ensure a proper fit. This kind of fit testing is not generally employed outside the workplace now and would probably not be feasible during a public health medical emergency.

FDA is requiring those who want to market respirators for use during public health medical emergencies to assure that they are certified by NIOSH to provide adequate filtration without hampering people's ability to breathe. In addition, companies must conduct fit assessment testing, conduct biocompatibility testing to reduce the chance for allergic skin reaction, and provide instructions that will enable wearers to achieve a protective fit and use the devices properly.

3M evaluated fit characteristics in healthy adults to determine that a user could achieve a protective fit following the instructions on the label. They measured how many airborne test particles were able to get inside the respirator through small leaks between the edges of the respirator and the wearer's face. While individual results varied, all participants tested achieved some reduction in exposure to airborne test particles.

The 3M respirators are sized for adults and may not form a proper fit on children. Anything that comes between the respirator and the face, such as facial hair, may interfere with its fit. Persons with pre-existing heart or lung disease or other health conditions may have difficulty breathing through a respirator. The devices are for single use. Wearers should not wash, disinfect, reuse or share their respirator with others. The respirators should be discarded after use.

FDA will soon issue a guidance document outlining its regulatory approach to this new type of device.

Inhaling particles is just one route of exposure to disease-causing organisms. Others include touching contaminated surfaces and coming into close contact with those who have infectious diseases. A total approach to personal protection includes hand hygiene, cough etiquette and other protection practices such as avoiding crowded settings.
          Raf Simons Becomes First Designer Since Calvin Klein to Win Both Womenswear and Menswear at CFDA Awards        

Well deserved.

read more

          Rock N Roll Manifesto 251        
FDA approved, Grade A prime, non-GMO, organic rock and fucking roll.
          IPAB revocation of Allergan’s Combigan patent: Viewing it through the lens of American patent doctrines        
Recently Anubha had blogged about the IPAB decision revoking Allergan’s patent for Combigan. Combigan refers to a combination eye-drop product used for treating glaucoma comprising combination of Brimonidine tartarate and Timolol maleate. Media reports termed this decision as the latest in a series of intellectual property setbacks suffered by Western drugmakers. These skewed reports also portray this revocation decision as one of many tactics by India to remove an inconvenient patent out of the way to introduce affordable generic versions. What these reports failed to highlight was that several claims of patents covering Combigan were invalidated as being obvious even in major jurisdictions like US and EU. Also it wasn’t as though the Indian patent was invalidated by applying one of those sections (eg. Section 3) which is unique to Indian patent law. An analysis of US CAFC decisions and IPAB decision for Combigan is presented below. Longish post, but hope to make it worth your while.

Image from here

Combigan US patents: Background

The patents in question are 4 OB listed patents related to Combigan viz: the ’463 patent, the ’258 patent, the ’976 patent and the’149 patent. The claims of '463, ‘258, and '976 patents with the exception of claim 4 of ‘149 patent were generally treated as a single group.

Claim 1 of ‘463 patent was considered representative and it states: 1. A composition comprising about 0.2% timolol by weight and about 0.5% brimonidine by weight as the sole active agents, in a single composition.
Sandoz sought to market a generic version of Combigan thus triggering litigation under Hatch Waxman framework. The district court rejected allegations that claim 1 of ‘463 patent was invalid as obvious over prior art. On appeal, the Fed circuit reversed the district court's finding that the claims of the '463 patent were non-obvious.The CAFC decision can be found here

Prior art: what was known at the time of invention?

Both timolol and brimonidine were commercially available drugs in their claimed concentrations used for ophthalmic conditions at the time of the invention. At the time of the invention, it was known that the serial administration of brimonidine and timolol reduced intraocular pressure greater than either timolol or brimonidine alone. Moreover, DeSantis (US 5502052), the primary prior art reference, expressly provided a motivation to formulate fixed combinations of alpha2-agonists and beta blockers, including timolol, in order to increase patient compliance.

District court findings:Summary
  • The court found that there would be no motivation to create the combination product because the FDA did not view patient compliance as a factor for approval.
  • Second, the court found that the formulation arts are unpredictable.
  • There were some teachings in the prior art that taught away from the claimed invention.
  • Finally, the court observed that there were secondary considerations that support the finding of non-obviousness including long-felt need and unexpected results.
Federal circuit: Do secondary considerations outweigh motivation to combine?

The CAFC addressed each of the findings of district court as follows:
  • Fed circuit opined that there is no requirement in the patent law that the person skilled in the art should be motivated to combine based on the rationale that forms basis for FDA approval. Motivation to combine may be found in many different places and forms; it cannot be limited to those reasons the FDA sees fit to consider in approving drug applications.
  • While agreeing that formulation sciences inherently contain a certain degree of unpredictability, the opinion stated that “obviousness cannot be avoided simply by a showing of some degree of unpredictability in the art so long as there was a reasonable probability of success.”
  • It also agreed that the prior art as a whole taught away from the invention.
  • Previous attempts to treat patients twice per day with brimonidine resulted in a loss of efficacy eight to nine hours post administration. This loss of efficacy is referred to as the “afternoon trough.” The court found that a twice per day dosage regimen of Combigan® unexpectedly did not suffer from the afternoon trough issue. The Fed circuit concurred with district courts findings that that this result was unexpected. However the CAFC maintained that there was a motivation to achieve better patient compliance. Whether or not that combination also solved problems associated with the afternoon trough, we find the motivation to make the combination was real.
Thus the CAFC opined that unexpected results and prior art teaching away were NOT sufficient to outweigh the other evidence of obviousness with respect to these formulation claims.

Claim 4 of ‘149 patent: A different conclusion?

As mentioned above, claim 4 of ‘149 patent was analyzed separately by Federal Circuit. Claim 4 of the ’149 patent is directed to reducing the daily number of doses of brimonidine without loss of efficacy by administering fixed combination and reads as follows:
4. A method of reducing the number of daily topical ophthalmic doses of brimonidine administered topically to an eye of a person in need thereof for the treatment of glaucoma or ocular hypertension from 3 to 2 times a day without loss of efficacy, wherein the concentration of brimonidine is 0.2% by weight, said method comprising administering said 0.2% brimonidine by weight and 0.5% timolol by weight in a single composition
While the federal circuit held that the formulation of 0.2%wt brimonidine and 0.5%wt timolol was obvious, it came to a different conclusion with respect to claim 4 of the '149 patent. The CAFC reasoned that although the prior art shows concomitant administration of brimonidine and timolol, it does not establish that switching from 3 times a day to 2 times a day does not result in loss of efficacy. Hence it concluded that claim 4 was NOT obvious in light of prior art.

Avoiding loss of efficacy an inherent result of the formulation?: Judge Dyk’s dissent

Dissenting from the majority’s opinion holding that claim 4 of the ’149 patent is not invalid as obvious Judge Dyk observed that avoiding loss of efficacy is an inherent result of the claimed method. Since the formulation was held obvious, inherent result /property of the formulation is also obvious. Judge Dyk reasoned a newly-discovered result or property of an existing (or obvious) method of use is not patentable.

The majority differed and observed that the prior art evidence does not conclusively establish that dose reduction “from 3 to 2 times a day without loss of efficacy” limitation is an inherent property or a necessary result of the administration.

IPAB decision:

The IPAB concluded “We too are of the opinion like the Federal Court that there was a reasonable expectation of success in view of the DeSantis. Therefore for the above reason, we find that the invention is obvious."

With regard to non-compliance of Section 8, the IPAB noted that the applicant had failed to inform the Controller regarding refusal of corresponding EU patent and various stages of prosecution in the US counterpart patents (non-final rejections etc.). Curiously, Allergan tried to argue that Therasense like inequitable conduct standards should be set for Section 8. In Therasense, Inc. vs. Becton, Dickinson and Co (Fed. Cir. 2011) an en banc decision, the Federal Circuit held that inequitable conduct must be shown with clear and convincing evidence and that there was intent to withhold or misrepresent information and that the information was material. However, the IPAB reasoned that our law does not make any qualification regarding the failure to disclose nor does it say that the failure to furnish the S.8 details must be deliberate and willful. The IPAB opined that even if it was to assume Therasense like standards for the present case but for that the fact that the EP office action and/or US office action were kept away from the Controller, the patent may not have been granted. The IPAB decision itself can be found here and Anubha’s post on the same can be accessed here.

What was different in the Indian decision?

In India, Combigan was protected by only one patent viz IN219504. Since method of treatment claims are precluded from patentability in India, claim 4 of ‘149 wasn’t patented. Since the claims of IN219504 were invalidated by IPAB, it paved way for generic entry (read Ajanta pharma).
On the other hand in US, as discussed earlier Combigan was protected by several patents (patent thicket). Even though Sandoz succeeded in establishing that claims of ‘463 patent were invalid as obvious, the Fed circuit ruled that claim 4 of 149 as not obvious. Thus market entry for generics (Sandoz) in US is barred until expiry of ‘149 patent i.e. April 19, 2022. 

          Starbucks stops using tainted milk in China        
Tainted Milk Starbucks Image

According to Bloomberg.com, Starbucks and its 300 plus cafes in China have stopped using milk by Mengniu Dairy CO. Mengniu, together with the other top milk producers in China, Inner Mongolia Yili Industrial Group Co. and Bright Dairy & Food Co., were part of the scandal where China found the toxic chemical melamine in the liquid milk and yogurt products they produce.

"Though we believe based on assurances from the supplier that the milk we received from Mengniu is not included in the contaminated lot, due to the serious nature of this warning, Starbucks has voluntarily pulled all Mengniu milk offerings until further notice," Starbucks said.

Melamine, used to make plastic and tan leather, is now being linked to the kidney failures in babies and leading to at least four deaths. Melamine, which is high in nitrogen, can be used to mask diluted milk because it makes protein levels appear higher than they really are, allowing producers to cut costs by watering down their products. [Read the full article]

Having stayed in China for a year back in 2006 and drinking milk almost everyday, I find it disturbing to know that my system must have been affected somehow by melamine. I seem okay and not affected by it but I think I'd like to have my system checked just to be sure. It's a little weird how they have the brand YiLi here in the Philippines and I was looking at it at the supermarket and I told the lady beside me that this is really good and she should get it since it's on sale. I wonder if as early as 2 weeks ago they already knew something was wrong with their milk. The expiration date is January 2009 so it couldn't be that hmm...

It's just crazy how their FDA didn't have much stricter standards when it comes to their milk, which is a $19 billion industry, and possibly even other food or drinks.

I wonder how Starbucks' sales have been the past few day and what alternatives they've been using for milk in their coffee. Soy maybe? If I were still staying in China and this happens to me, I'd be drinking my coffee black, which is something I rarely do. I haven't tried using soy as an alternative or I could be happy with using creamers that are imported just as long as I know it's safe.

This comes at a very bad time especially after China spent a lot during the Olympics where they were trying to tell the world that "We are now open, come visit us!" Only time will tell whether they can bounce back from this and still continue their image that started in the Olympics.

Photo by: SMCP

          "Asparagus For Cancer"        

"Asparagus For Cancer"

Dalibor Moyzes
Subject: Asparagus DO NOT FAIL TO READ THIS AND SEND TO YOUR FAMILY &FRIENDS When I was in the USN, I was stationed in Key West, FL. I worked at the clinic at Naval Air Station on Big Coppitt Key just a few miles north of Key West. The hospital at Key West was for out- patients only, for retired armed forces personnel that lived in the area. If you needed to be hospitalized you were sent to Homestead AFB Florida. I had the day off and just went inside the hospital (Corpman barracks were next to hospital). There was a retired Navy man that worked in the lab and he was very interesting gentleman to talk with. He was a retired biochemist from the USN. He asked me what was going on that day,and I said I had the day off. I wish I was working, as the crew on, today was taking a sailor to Homestead as he had a very bad kidney infection. Now this elderly gent told me the man should have eaten more asparagus, and he wouldn't have that problem. I asked why? I'll never forget him saying, do you eat asparagus? and I said yes, I love them. He replied you notice how your urine stinks after eating asparagus? I said well I never thought it was what I ate but yes it does have a pungent odor. He said, It is because it is detoxifying your body of harmful chemicals!!! This was back in 1986 when I was stationed there and to read this email again I had to share this story...Eat more asparagus, my friends.

Asparagus -- Who knew?
My Mom had been taking the full-stalk canned style asparagus, pureed it and took 4 tablespoons in the morning and 4 tablespoons later in the day. She did this for over a month. She is on chemo pills for Stage 3 lung cancer in the pleural area and her cancer cell count went from 386 down to 125 as of this past week. Her oncologist said she will not need to see him for 3 months.

Several years ago I met a man seeking asparagus for a friend who had cancer. He gave me a copy of an article, entitled "Asparagus For Cancer" printed in the Cancer News Journal, December 1979. I will share it here, just as it was shared with me: I am a biochemist, and have specialized in the relation of diet to health for over 50 years. Several years ago, I learned of the discovery of Richard R. Vensal, D.D.S. that asparagus might cure cancer. Since then, I have worked with him on his project. We have accumulated a number of favorable case histories. Here are a few examples:

Case No. 1, A man with an almost hopeless case of Hodgkin's disease (cancer of the lymph glands) who was completely incapacitated. Within 1 year of starting the asparagus therapy, his doctors were unable to detect any signs of cancer, and he was back on a schedule of strenuous exercise

Case No. 2, A successful businessman, 68 years old, suffered from cancer of the bladder for 16 years. After years of medical treatments, including radiation without improvement, he began taking asparagus. Within 3 months, examinations revealed that his bladder tumor had disappeared and that his kidneys were normal.

Case No. 3, On March 5th 1971, a man who had lung cancer was put on the operating table where they found lung cancer so widely spread that it was inoperable. The surgeon sewed him up and declared his case hopeless. On April 5th he heard about the Asparagus therapy and immediately started taking it. By August, x-ray pictures revealed that all signs of the cancer had disappeared. He is now back at his regular business routine.
Case No. 4, A woman had been troubled for a number of years with skin cancer. She developed different skin cancers which were diagnosed by the acting specialist as advanced. Within 3 months after beginning asparagus therapy, the skin specialist said her skin looked fine with no more skin lesions. This woman reported that the asparagus therapy also cured her kidney disease, which had started in 1949. She had over 10 operations for kidney stones, and was receiving government disability payments for an inoperable, terminal, kidney condition. She attributes the cure of this kidney trouble entirely to the asparagus treatment.

I was not surprised at this result as `The elements of materia medica', edited in 1854 by a Professor at the University of Pennsylvania, stated that asparagus was used as a popular remedy for kidney stones. He even referred to experiments, in 1739, on the power of asparagus in dissolving stones. Note the dates! ---We would have other case histories but the medical establishment has interfered with our obtaining some of the records. I am therefore appealing to readers to spread this good news and help us to gather a large number of case histories that will overwhelm the medical skeptics about this unbelievably simple and natural remedy.

For the treatment, asparagus should be cooked before using. Fresh or canned asparagus can be used. I have corresponded with the two leading canners of asparagus, Giant and Stokely, and I am satisfied that these brands contain no pesticides or preservatives. Place the cooked asparagus in a blender and liquefy to make a puree. Store in the refrigerator. Give the patient 4 full tablespoons twice daily, morning and evening. Patients usually show some improvement in 2-4 weeks. It can be diluted with water and used as a cold or hot drink. This suggested dosage is based on present experience, but certainly larger amounts can do no harm and may be needed in some cases.

As a biochemist I am convinced of the old saying that `what cures can prevent.' Based on this theory, my wife and I have been using asparagus puree as a beverage with our meals. We take 2 tablespoons diluted in water to suit our taste with breakfast and with dinner. I take mine hot and my wife prefers hers cold. For years we have made it a practice to have blood surveys taken as part of our regular checkups. The last blood survey, taken by a medical doctor who specializes in the nutritional approach to health, showed substantial improvements in all categories over the last one, and we can attribute these improvements to nothing but the asparagus drink. As a biochemist, I have made an extensive study of all aspects of cancer, and all of the proposed cures. As a result, I am convinced that asparagus fits in better with the latest theories about cancer.

Asparagus contains a good supply of protein called histones, which are believed to be active in controlling cell growth. For that reason, I believe asparagus can be said to contain a substance that I call cell growth normalizer. That accounts for its action on cancer and in acting as a general body tonic. In any event, regardless of theory, asparagus used as we suggest, is a harmless substance. The FDA cannot prevent you from using it and it may do you much good. It has been reported by the US National Cancer Institute, that asparagus is the highest tested food containing glutathione, which is considered one of the body's most potent anticarcinogens and antioxidants.

Just a side note... In case you are wondering why this has not been made public, there is no profit in curing cancer.

Please send this article to everyone in your Address Book. The most unselfish act one can ever do is paying forward all the kindness one has received.

posted by 
Alex W Fraser
Courtenay, BC

          Chemical Resistant Plastics        
All of the plastics discussed in this blog have remarkable chemical resistance; PVDF and Ultem have resistance up to pH 11. These plastics are therefore often used in corrosive or acidic environments, offering solutions to problems that other materials cannot. Some popular plastics with extreme chemical resistance are: Ketron PEEK Techtron HPV PPS Ultem PEI 1000 Symalit PVDF 100 Ketron PEEK PEEK- Polyetheretherketone. PEEK has a unique combination of high mechanical properties and temperature resistance. It has an extremely high maximum service temperature (250⁰C continuously and up to 310⁰C for short periods of time) as well as being flame-resistant and thermally stable. PEEK has excellent retention of strength and stiffness, creep resistance over a wide temperature range and excellent wear and frictional behaviour. PEEK is often used to replace PTFE when higher mechanical load bearing capacity, or when superior wear resistance is needed. Also widely used as a replacement for metal components. Applications of PEEK include pump components, valve seats, bearings, pistons, rollers, gears, high temperature insulators, components exposed to boiling water or steam. PEEK is used in aerospace, automotive and chemical processing industries. PEEK is also used for medical applications. Techtron HPV PPS PPS- Polyphenylene Sulfide Techtron was developed to close the gap both in performance and price between the standard thermoplastic materials (e.g. PA, POM, PET) and the high-end advanced engineering plastics (e.g. PBI, PI, PAI, PEEK). Techtron has a high maximum service temperature, as it can operate at 220⁰C continuously. Techtron has a high retention of strength and stiffness, creep resistance over a wide temperature range, excellent wear behaviour and good electrical insulating and dielectric properties. It also has good UV-resistance and is physiologically inert (suitable for food contact). Techtron is used in industrial equipment such as industrial drying and food processing ovens, bearings, rollers, chemical process equipment, pump, valve and compressor components and electrical insulating systems. It is also used in manifolds, distributor valves, medical equipment components and steam cleaning equipment inserts. Ultem PEI 1000 PEI- Polyether Imide. Ultem is amber coloured and translucent. Ultem has high strength, stiffness and heat resistance (performs continuously to 170⁰C), making it ideal for high strength / high heat applications. Ultem has excellent abrasion resistance, excellent ageing stability and UV resistant. High dielectric and piezoelectric values. Ultem is FDA compliant. Thanks to its good hydrolysis resistance, ULTEM PEI 1000 is capable of withstanding repeated autoclaving cycles (good for surgical probes). Applications of Ultem include manifolds (offer resistance to hot chemical solutions), insulators and clamps (high voltage and flame resistance). Symalit PVDF 100 PVDF- Polyvinylidene Fluoride. PVDF has good mechanical, thermal and electrical properties and shows good resistance to high-energy radiation (considerably better than other fluoropolymers). PVDF has excellent abrasion resistance, excellent ageing stability and UV resistant. PVDF also has high dielectric and piezoelectric values. PVDF is suitable for the manufacture of components for the petro-chemical, chemical, metallurgical, food, paper, textile, pharmaceutical and nuclear industries.
          Iowa Farm Resumes Selling Eggs After Recall        
The smaller of the two major egg farms involved in the FDA recall over the summer has resumed shipping eggs. The larger farm may
          FDA Requires Testosterone Medication Manufacturers to Add Expanded Blood Clot Risk to Warning Labels, Baron and Budd Reports        

Required Change Reflects Reports of Additional Clotting Not Related to Condition Covered by Current Warnings

(PRWeb July 17, 2014)

Read the full story at http://www.prweb.com/releases/2014/07/prweb12016998.htm

          FDA Sends Warning Letter to Transvaginal Mesh Manufacturer American Medical Systems, National Law Firm Baron and Budd Reports        

Letter Cited Several Issues Found After Inspection of Company’s Minnesota Plant

(PRWeb June 11, 2014)

Read the full story at http://www.prweb.com/releases/2014/06/prweb11932645.htm

          Smartphone microscope and app for testing your sperm        

YO is an FDA-cleared sperm quality analyzer for your smartphone. It consists of a detachable mini microscope and light that clips to your mobile phone. You "acquire" a sperm sample, drop it into the YO Clip, and the app records a video of your sperm in action and analyzes the activity. Available in January, you can pre-order two tests for $50. I bet the app has social media integration so if you have strong swimmers, you can proudly share the proof with your friends.

"Extensive testing has been performed on the YO Home Sperm Test—over four years to be exact," Marcia Deutsch, CEO of Medical Electronic Systems, the parent company of YO Sperm Test and producer of commercial-grade semen analyzers for major labs, tells Fit Pregnancy. "The technology is able to read the sperm sample 99 percent of the time, as long as the instructions are followed. [If it can read the test] the results are more than 97 percent accurate based on FDA studies of 316 participants."

Because it's an over-the-counter product, Deutsch says the test can't reveal actual values, but rather gives a reading of "low" or "moderate/normal" based on World Health Organization (WHO) guidelines for sperm motility (how well they move) and concentration (how many there are). The test reports a composite of these two parameters called "motile sperm concentration," or the number of moving sperm.

YO Sperm Test (via Uncrate)

          clarinex dosing        
Looking for clarinex without prescription? No problem! BUY CLARINEX ONLINE - CLICK HERE! time: 10.03.2012 Author: duegroovse clarinex dosing Clarinex Official FDA information, side effects and uses. Clarinex pediatric dosing, interactions, and patient education at Epocrates Online, the leading provider of drug and disease decision support tools. Clarinex (Desloratadine) Drug...
          House Holds mHealth Hearings, FDA Promises Final Guidance Forthcoming        
Three days of hearings by a House of Representatives committee concluded yesterday with a pledge from an FDA official to finalize long-awaited guidance on the regulation of mobile medical applications “in coming weeks“; at the latest by the end of the FDA’s fiscal year (i.e., September 30th). The hearings, convened jointly by several subcommittees of […]
          The FDA, Social Media & Consumer Genomics: A Lot Not to “Like”        
Last week, the FDA published on its website a warning letter to AMARC Enterprises, Inc., a marketer of a dietary supplement known as Poly-MVA. (Here is the company’s description of the supplement.) While the letter is not addressed to a high-profile company or product, given that the FDA’s action will likely have broader significance beyond just […]
          23andMe Seeks FDA Clearance (Podcast)        
Last week, personal genetics company 23andMe announced that it had formally delivered the first round of documentation to the U.S. Food and Drug Administration (FDA) in an attempt to receive 510(k) clearance for its consumer product. 23andMe declared itself “first in the [ direct-to-consumer (DTC) genetic testing] industry to announce it is working towards FDA […]
          Tobacco Investors Just Learned That Trump Isn’t the Salvation of Every Odious Industry        

The tendency to lean on political beliefs is one of the most powerful forces in investing and financial media, and one of the most dangerous. There’s a general sense that Republicans are good for business (lower taxes, fewer regulations, an overall permisiveness) and therefore good for the stock market. And there’s a sense that Democrats are bad for business (higher taxes, more regs, a skepticism toward industry’s prerogatives) and therefore bad for the stock market. The lived experienced of the markets over the past 25 years—booming under Clinton and Obama, tanking under Bush—should give the lie to this feeling. But it endures. And it has become particularly powerful under Trump, who regards the stock market as a kind of real-time approval gauge.

But doing so is precarious. And it can be continually confounding at the macro level and at the level of sectors and individual companies. That’s a lesson that investors who held stocks in tobacco companies—in particular the biggest one, Altria (formerly Philip Morris)—learned Friday.

Tobacco companies are in a strange position right now. Smoking is on the decline in the U.S., in part because of government efforts to discourage it via higher taxation, regulation, outright bans, and President Obama’s use of the bully pulpit and the executive pen. Only about 15.1 percent of Americans smoked in 2016, down from about 21 percent in 2005, according to the Centers for Disease Control and Prevention. And yet the profits of tobacco companies, paradoxically, are booming, in part because sales overseas are growing and in part because tobacco companies have the ability to raise prices. (That’s one of the advantages of making a product that is addictive.) Altria’s profit margins on tobacco products are remarkably high. Between 2001 and 2016, as the chart on Page 11 of Altria’s annual report shows, Altria’s stock nearly tripled, while the S&P 500 merely doubled.

Altria’s stock, like many others, continued to soar after Trump’s election—up about 10 percent in the first half of the year. It’s not hard to see why. Aside from benefiting from the general pro-business agenda of Trump—cutting corporate taxes, reducing the capital gains tax, and so on—Altria would seem to have far less to fear from a Trump administration than from an Obama or Clinton administration. While he doesn’t drink or smoke, Trump isn’t a particularly healthy person: He doesn’t work out or exercise or maintain a healthy diet. His administration has backed measures that would cut health care spending by hundreds of billions of dollars, some of which is now spent on smoking cessation. The Trump administration is full of lobbyists and corporate types eager to do the bidding of companies. The likelihood of the first family engaging in aggressive anti-smoking campaigns is laughable. Altria kicked in $500,000 to fund the Trump inauguration.

And the person Trump named to be the head of the Food and Drug Administration, which regulates tobacco, doesn’t have a history of anti-smoking activism. Scott Gottlieb is a physician, biotech investor, and former resident fellow at the American Enterprise Institute who also served in the Bush administration. What’s more, Gottlieb has been strongly in favor of deregulating pharmaceuticals and medical devices, as part of an effort to bring innovations to market more quickly and reduce costs.

And yet Friday morning, with little apparent warning, Gottlieb announced a new comprehensive plan to regulate nicotine. In an aggressive speech that spoke about cigarettes and nicotine in harsh terms, Gottlieb said “we need to envision a world where cigarettes lose their addictive potential through reduced nicotine levels.” For this reason, Gottlieb said, “I’m directing our Center for Tobacco Products to develop a comprehensive nicotine regulatory plan premised on the need to confront and alter cigarette addiction.” With a “balanced regulatory approach,” he noted, “we may be able to reach a day when the most harmful products are no longer capable of addicting our kids.”

This clearly came as a surprise to the companies and to their investors. Stocks reacted violently. In about 30 minutes, Altria’s stock fell 15 percent, sawing nearly $21 billion in market capitalization off the company. By later in the afternoon, the stock had stabilized, though it was still off by about 10 percent, or about $14 billion.

Clearly, investors and the tobacco companies believed that the Trump FDA would take a more hands-off approach to regulating tobacco. After all, we’ve seen sharp pullbacks from regulation of toxic emissions and substances at the Environmental Protection Agency and a general desire to rip up consumer protections. But just because there’s a general air of deregulation, and just because people now in positions of responsibility are hostile to scientific consensus (hello, EPA and Interior), doesn’t mean that all important executive-branch appointees do so.

That’s the mistake tobacco investors made. Gottlieb, after all, is a physician, and a cancer survivor to boot. The science and medicine surrounding tobacco is long since settled, and the consensus is broad. The product has been regulated, without much controversy, for several decades. Everybody involved in health care really hates tobacco, an addictive product that has a host of really bad, expensive, and predictable effects on people’s health. “As a physician who cared for hospitalized cancer patients, and as a cancer survivor myself, I saw first-hand the impact of tobacco,” Gottlieb said in a speech Friday. “And I know all too well that it’s cigarettes that are the primary cause of tobacco-related disease and death. What’s now clear is that FDA is at a unique moment in history, with profound new tools to address this devastating impact.”

Not all of Trump’s appointees will be pro-corporate stooges at all times. And investing as if they are can be remarkably expensive.

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          Drugs@FDA Download File (new structure)        
Data files updated through August 9, 2017.
          Drugs@FDA Data Files        
Data files updated through August 9, 2017.
          FDA Drug Safety Communication: Risk of oral clefts in children born to mothers taking Topamax (topiramate)        
[03-04-2011] The U.S. Food and Drug Administration (FDA) is informing the public of new data that show that there is an increased risk for the development of cleft lip and/or cleft palate (oral clefts) in infants born to women treated with Topamax (topiramate) during pregnancy.
          FDA Drug Safety Communication: New warnings against use of terbutaline to treat preterm labor        
[02-17-2011] The U.S. Food and Drug Administration (FDA) is warning the public that injectable terbutaline should not be used in pregnant women for prevention or prolonged treatment (beyond 48-72 hours) of preterm labor in either the hospital or outpatient setting because of the potential for serious maternal heart problems and death.
          FDA Drug Safety Communication: Liver injury warning to be removed from Letairis (ambrisentan) tablets        
The U.S. Food and Drug Administration (FDA) is removing the warning related to liver injury from the boxed warning of the Letairis (ambrisentan) tablet label.
          FDA Drug Safety Communication: Special storage and handling requirements must be followed for Pradaxa (dabigatran etexilate mesylate) capsules        
[03-29-2011] The U.S. Food and Drug Administration (FDA) is alerting the public to important storage and handling requirements for Pradaxa (dabigatran etexilate mesylate) capsules.
          FDA Drug Safety Communication: Connection problems involving certain needleless pre-filled glass syringes containing adenosine and amiodarone        
[05-06-2011] The U.S. Food and Drug Administration (FDA) is alerting the healthcare community about syringe connection problems when certain needleless glass syringes containing the cardiac drugs adenosine and amiodarone are used with particular types of intravenous (IV) access systems.
          FDA Drug Safety Communication: No increase in risk of cancer with certain blood pressure drugs--Angiotensin Receptor Blockers (ARBs)        
[06-02-2011] The U.S. Food and Drug Administration (FDA) has completed a review of the potential risk of cancer associated with the class of medications known as angiotensin receptor blockers (ARBs). FDA has concluded that treatment with an ARB medication does not increase a patient’s risk of developing cancer.
          FDA Drug Safety Communication: 5-alpha reductase inhibitors (5-ARIs) may increase the risk of a more serious form of prostate cancer        
[6-9-2011] The U.S. Food and Drug Administration (FDA) is informing healthcare professionals that the Warnings and Precautions section of the labels for the 5-alpha reductase inhibitor (5-ARI) class of drugs has been revised to include new safety information about the increased risk of being diagnosed with a more serious form of prostate cancer (high-grade prostate cancer).
          FDA Drug Safety Communication: Addition of another concentration of liquid acetaminophen marketed for infants        
          FDA Drug Safety Communication: Selective serotonin reuptake inhibitor (SSRI) antidepressant use during pregnancy and reports of a rare heart and lung condition in newborn babies        
[12-14-2011] The U.S. Food and Drug Administration (FDA) is updating the public on the use of selective serotonin reuptake inhibitor (SSRI) antidepressants by women during pregnancy and the potential risk of a rare heart and lung condition known as persistent pulmonary hypertension of the newborn (PPHN).
          FDA Drug Safety Communication: Modified Risk Evaluation and Mitigation Strategies (REMS) for Nplate (romiplostim) and Promacta (eltrombopag)        
          FDA Drug Safety Communication: Drug labels for the Tumor Necrosis Factor-alpha (TNFα) blockers now include warnings about infection with Legionella and Listeria bacteria        
[9-07-2011] The U.S. Food and Drug Administration (FDA) is informing healthcare professionals that the Boxed Warning for the entire class of Tumor Necrosis Factor-alpha (TNFα) blockers has been updated to include the risk of infection from two bacterial pathogens, Legionella and Listeria.
          FDA Drug Safety Communication: Serious allergic reactions reported with the use of Saphris (asenapine maleate)        
[09-01-2011] The U.S. Food and Drug Administration (FDA) is warning the public that serious allergic reactions have been reported with the use of the antipsychotic medication Saphris (asenapine maleate).
          FDA Drug Safety Communication:Use of long-term, high-dose Diflucan (fluconazole) during pregnancy may be associated with birth defects in infants        
[8-03-2011] The U.S. Food and Drug Administration (FDA) is informing the public that chronic, high doses (400-800 mg/day) of the antifungal drug Diflucan (fluconazole) may be associated with a rare and distinct set of birth defects in infants whose mothers were treated with the drug during the first trimester of pregnancy.
          FDA Drug Safety Communication: Reminder to healthcare providers and patients to enroll in the Avandia-Rosiglitazone Medicines Access Program        
[11-04-2011] The U.S. Food and Drug Administration (FDA) is reminding healthcare providers and patients about the need to enroll in the Avandia-Rosiglitazone Medicines Access Program by November 17, 2011 in order to continue prescribing and receiving rosiglitazone-containing medicines (Avandia, Avandamet, and Avandaryl).
          FDA Drug Safety Communication: Review update of Multaq (dronedarone) and increased risk of death and serious cardiovascular adverse events        
[12-19-2011] The U.S. Food and Drug Administration (FDA) has completed a safety review of the heart drug Multaq (dronedarone). This review showed that Multaq increased the risk of serious cardiovascular events, including death, when used by patients in permanent atrial fibrillation (AF).
          Addiction and Mental Health Expert Ben Brafman Weighs in on FDA Painkiller Approval        

The Food and Drug Administration (FDA) recently approved Zohydro to treat chronic pain, an opiate that some experts fear may be highly addictive.

(PRWeb November 01, 2013)

Read the full story at http://www.prweb.com/releases/2013/11/prweb11294211.htm

          Comment on Legislature debates tobacco tax hike by Michelle La Pointe        
Come on people it is time to start telling the truth instead of telling people its an health issue, it is a way to raise revenue to fund schools and state gov. If gov. was so concerned with smokers health why didn't they use the millions of dollars obtained from law suits from the tabacco companies years ago? Hey why not raise the cigarette tax $5 dollars a pack and smokers could pay down the deficit and give politicians more wiggle room for reckless spending? The gov. and FDA is allowing GMOs in the food we eat,last I heard insecticides and herbacides aren't good for human consumption, and over time will cause health problems for all who consume foods with GMOs.If gov. is so concerned with everyones health, why are they not addressing the health risks of GMOs?
          Comment on E-cigarettes not recommended without FDA approval by Frankie Guinle        
Wow, 180 websites would be a lot of work. We struggled in the past with 20 that was too many. At one time we realised it wasnt going to work and just let them go. We didn't sell them or anything but we just didnt work on them anymore and focused solely on one website. That was the turning point for us.
          Comment on E-cigarettes not recommended without FDA approval by Karoline Pulkrabek        
It's really a cool and helpful piece of info. I'm glad that you shared this helpful information with us. Please keep us up to date like this. Thanks for sharing.
          Comment on California : Cigarette sales drop following new tax implementation by charlie        
Last Friday the FDA announced they will delay the ecig deeming rules for 5 years. At the same time they announce the intention to use their existing authority to nearly eliminate nicotine from cigarettes and encourage smokers to get their nic fix from less harmful and less expensive sources--like ecigarettes. When smoking parents switch to vaping it's a big economic benefit to families. There should be no interference with this.
          FDA Defends Its Decision of Lawsuit Against Cigarette Companies        
To rebut the contention of five of the nation’s largest cigarette manufacturing giants by way of a lawsuit, the U.S. Food and Drug Administration has sought court orders blocking any delay in implementing the new regulations that require graphic warning labels on cigarette packages to take effect from September 2012. The plea of economic harm […]
          FDA Officially Bans Texas' Attempted Import Of Execution Drugs        
Almost two years after Texas tried to import an execution drug from overseas, the U.S. Food and Drug Administration ruled Thursday that the drug can’t be admitted into the United States.
          Could the FDA Sanction Texas for Buying Lethal Drugs from India?        
From Texas Standard: Back in July, Texas and Arizona were caught illegally importing a lethal injection drug compound as the product was passing through an airport in Houston. The federal Food and Drug Administration, responsible for food and drug regulation in the United States, has said in the past that importing the drug is illegal. The Texas Department of Criminal Justice told the Dallas Morning News that the department had a license from the Drug Enforcement Administration saying the state could import the drug.
          Buzz on Pringles Recall – Potential Threat in Health        
There is another recall alert spreading on the news today as the FDA advised Proctor & Gamble to recall their latest Pringles being manufactured and distributed to stores.  There is a potential threat to the consumer’s health and the threat may be a big issue. Salmonella was found in one of the machines that manufacture […]
          I took Dutasteride and have had a massive hair shed in the first 2 weeks        

Dutasteride is not approved by the FDA for hair loss.  Documentation about such sheds is not available except in the hands of the doctors who prescribe it in what is called an “off label” circumstance. I am sure that it behaves like Finasteride, which suggests that the shed should reverse in 2-3 months. This patient […]

The post I took Dutasteride and have had a massive hair shed in the first 2 weeks appeared first on Hair Loss Information.

          Safety & Risk Conference        

November 12-13, 2009

Safety & Risk Conference

Program Overview
Risk control and safety are of vital concern to every warehouse-based logistics operation.
Improve your effectiveness in controlling industry-specific risk through analysis of case studies, expert presentations and group discussion. Network with peers who face similar challenges. Gain the knowledge you need to keep your company strong and nimble in an uncertain world.

Who Should Attend
This conference is geared to safety and human resources managers, previous attendees (all new sessions!), IWLA Insurance Company members, and supervisors whose responsibilities include identifying and managing warehouse safety and risk.

Program Agenda
1. CSA 2010 (Comprehensive Safety Analysis 2010)
Terry Lewis, Senior Vice President of Sales, Compliance Safety Systems
Lewis will address: (a) the purpose of the CSA 2010 initiative; (b) the CSA 2010 operational model; (c) the Behavioral Analysis and Safety Improvement Categories (BASICs) and how are they used in CSA 2010; (d) the difference between SafeStat and the new Safety Measurement System; and (e) the difference between a compliance review and CSA 2010 interventions.

2. New Materials: Risks & Regulatory Requirements
Ernie Harben, CLP, Sr Manager of Safety & Regulatory Compliance, Saddle Creek Corporation; Michael Lopeman, Division VP, Artex Risk Solutions
In these challenging economic times, warehouses consider new opportunities to expand customers and products or experience special pressures from customers to take on products not handled previously. Harben and Lopeman will review the importance of establishing a critical path for analysis and review of materials before handling or transporting, and the organizational structure needed to ensure that your company only handles those materials for which your facility is approved, safe storage and insurance requirements are maintained, and your employees are trained. Material Safety Data Sheets (MSDS) will also be discussed.

3. Pending FDA Legislation & Its Impact on Warehousing
Craig Henry, PhD, Sr. VP & COO, Scientific and Regulatory Affairs, Grocery Manufacturers Association
There has been a growing consensus that reform and changes are needed in our food safety system, and as a result, comprehensive food safety legislation has been introduced by Congress. This legislation includes measures to reform the Food and Drug Administration’s (FDA’s) oversight of food and imposes a variety of new requirements on food producers, manufacturers, handlers, and distributors. Some proposed legislation is calling for “farm-to-fork” traceability as well as potential changes to the FDA Reportable Food Registry. This session will provide the latest thinking on how regulators and industry are approaching this most challenging legislation involving producers, manufacturers, distributors, brokers and retailers.

4. DOT Mock Audit Overview
David Saunders, President & CEO, Compliance Safety Systems
Saunders will review the various factors in a DOT audit, including financial responsibility (49 CFR part 387) and assistance in investigations and special studies (49 CFR part 390); controlled substance and alcohol testing (49 CFR part 382) and qualification of drivers (49 CFR part 391); hours of service (49 CFR part 395); inspection, repair, and maintenance (49 CFR part 396); hazardous materials (part 397 of the FMCSR and parts 171, 177 & 180 of the HMR, 49 CFR); and accident ratio.

5. Safety Success Stories: Learn What Works from Warehouse Operators
Facilitators: Quentin Beitler, President, W.J. Beitler Co. & Beitler Trucking; Melissa Dempsey, HR & Safety Manager, Camrett Logistics; Bill Lorenzen, Safety Director, Price Transfer Inc.
Conference attendees represent warehouse and trucking operators and safety and risk practitioner’s collectively with hundreds of years of experience. In this session attendees will break out into small groups with an experienced facilitator supporting each group. Groups will IDENTIFY and SHARE BEST SAFETY PRACTICES they have used in their operations.

. Warehouse & Transportation Security
Daniel Day, Loss Prevention & Security Manager, Kenco Management Services, LLC
Cargo theft and warehouse burglaries are on the rise and criminals continue to be more brazen and bold in their actions. This session will provide an overview of current trends in warehouse burglaries and cargo thefts being seen throughout the United States. We will also suggest and discuss possible countermeasures facilities can implement to improve their overall security program, while protecting their employees, facilities, and inventory.

7. Verst Group Logistics: Sharing Safety Best Practices that Work
Mike Hart, Safety Director, Verst Group Logistics
To lower worker’s compensation expenses and send employees home safe, Verst Group Logistics has developed safety best practices that have enabled Verst to reduce its incident rates by over 75% in less than 2 years. Verst facilities range in size from 10 to over 450 employees, and are all well on their way to achieving safe operations excellence. In this interactive discussion, Hart will review the best practices and tools that will equip your managers and supervisors to make better coaches, including incident investigations, how to get total involvement, as well as a wide range of proactive tools.

8. Transportation Accident Investigation/Immediate Response & Forensics
Lew Bricker, Partner, SmithAmundsen
Catastrophic events can happen at any time. To best protect your company you have to be prepared in advance. Trying to determine what you need to do after the catastrophic event increases risk, maximizes exposure, wastes money and decreases results. This session examines best practices and strategies for managing catastrophic events during the first 24 hours, 7 days, and beyond so that you can minimize liability in emergency response situations.

9. OSHA Updates: Key Issues & Programs Impacting Warehousing
Bill Coulehan, Compliance Assistant Specialist, U.S. Dept of Labor, OSHA
Coulehan will address new enforcement potential, including record keeping and enforcement of personal protection equipment (PPE). He will also discuss the benefits of Voluntary Protection Programs (VPP) that promote effective worksite-based safety and health. In the VPP, management, labor, and OSHA, through cooperative relationships, have implemented comprehensive safety and health management systems. There are three ways to participate in VPP: site-based, mobile workforce, and corporate. Approval into the VPP is OSHA’s official recognition of the outstanding efforts of employers and employees who have achieved exemplary occupational safety and health.

10. Cargo Theft
Mary Aftanas, Commercial Director, National Insurance Crime Bureau
Updates on ways to address and fight cargo theft. Update on National task force on Cargo Theft and local initiatives.

11. IWLAIC Advocacy Group
Phyllis Stockfish, Sr. VP, Artex Advocacy Group
IWLAIC has recently introduced a new service to its members, Client Advocacy. The Client Advocate Group is made up of 9 professionals who collectively have over 158 years of claims and risk management experience. This presentation will help you to fully understand the service and how to effectively use it to manage your business. As a part of the presentation we will discuss the value of Witness Statements. Every incident should be investigated and every investigation should have a well thought out plan to obtain witness statements. These statements can be used for Preservation, Impeachment, Settlement and Prevention. This presentation is created to assist you in identifying when to take a statement, how to take an admissible statement and how to avoid the pitfalls of dealing with hostile witnesses.

CLP Points: 15 CLP Points
Location: Hyatt Rosemont
6350 N River Rd
Rosemont, IL 60018
Phone: 847-518-1234
Fax: 847-518-0855

Contact: Linda Wood, Assistant VP of Education, ext 279
Email: lwood@iwla.com
File: Agenda
File: Faxed Registration Form
File: Hotel Information
File: Speakers' Names and Biographies

Agenda and speakers subject to change without notice

Refund Policy
All session cancellations must be received in writing by October 5, 2009 for a full refund less a $150 cancellation fee for each session. No refunds will be given after this date. Substitutions will be accepted.

Cancellation Policy
Please note that in the unlikely event of program cancellation, the IWLA Education & Research Foundation is not responsible for incidental costs incurred by registrants.

Special Needs
If you have special needs or requirements, please notify Linda Wood at
lwood@iwla.com by October 5, 2009, and IWLA will do its best to accommodate you.

IWLA Insurance Captive members use special site or fax to register; contact lwood@iwla.com for link.

For ease of use, before proceeding to Register Now!, please disable all Popup Blockers on your web browser.

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On September 26, UCLA researcher reported the results of a study, which indicated that Asians who're struggling with alcoholism may benefit especially from naltrexone, one of three medications authorized by the U.S. Food and Drug Administration (FDA) for the treatment of alcoholism. Recent research has found that a gene variant may predict naltrexone treatment success for alcoholism. About 50% of patients of Asian descent have a particular mutation which makes them likely to benefit from naltrexone, in comparison with about 20% of Caucasians and less than 5% of African Americans, said lead study author Lara Ray, an assistant professor of psychology and director in the UCLA Addictions Laboratory. The findings are still available online ( in the journal Neuropsychopharmacology and are published in a upcoming print edition of the journal.

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Combo-pilling will be the newest fad or in addition to this the newest into the future under scrutiny and therefore it is just more publicly known although in the past, comb-pilling for weight loss has been around since the eighties. The biggest reason that by using a combination of pills is becoming popular will be the fact that as of right now there are no long term prescription weightloss pills that have been approved by the FDA besides orlistat. The truly disturbing part is always that doctors are prescribing these combinations of medications however some of the combinations have been rejected or have yet to be authorized by the FDA.

Seizures can be a side effect with Contrave and mustn't be taken in individuals with seizure disorders. The drug can also raise blood pressure and pulse rate, and shouldn't be used in people who have a history of heart attack or stroke in the last six months. Blood pressure and pulse should also be measured before commencing the drug and throughout therapy using the drug.

The FDA also warned that Contrave can raise hypertension and heart rate and must stop used in patients with uncontrolled high blood pressure level, in addition to by a person with heart-related and cerebrovascular (circulation system dysfunction impacting the brain) disease. Patients using a history of heart attack or stroke in the previous six months, life-threatening arrhythmias, or congestive heart failure were excluded through the clinical trials. Those taking Contrave really should have their heart-rate and pulse monitored regularly. In addition, because the compound includes bupropion, Contrave comes having a boxed warning to alert physicians and patients to the increased chance of suicidal thoughts and behaviors associated with antidepressant drugs. The warning also notes that serious neuropsychiatric events have been reported in patients taking bupropion for stop smoking.

To keep up with essentially the most current articles from Wendi, the Indiana Addiction Recovery Examiner, click the subscribe link near the top of the page for email notification when new articles are published. Please leave a comment for any article.

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The Wellbutrin causes headaches and sleep problems. It would swoop over me, and I'd experience this horrible plummeting sensation and feel as if the wind was knocked out of me. My case is much different than those simply taking this drug for psychological disorders only so if you experience those more severe side affects you need to take them very seriously. Indigestion is really a basic culprit in putting on weight, especially for people that eat a reasonable diet.

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The prior article on this series presented the standard treatments for opiates addiction. Suboxone allows a new approach.

Using two separate drugs to shed weight can be very effective you'll find combinations in front of the FDA now awaiting approval. When dealing with weight-loss and the individuals who go through it you need to err to the side of caution and allow the FDA do its job and demand some research be done so your public is aware of the side effects and risks of the medications before we take them. Keep in mind that drug companies have been in business to generate money and that they would say almost anything to keep people on their medications.

Researchers discovered that participants using this drug to get a year, lost weight within 4 weeks and have kept the extra weight off throughout the 56 weeks from the study. Contrave can be a combination of the drugs naltrexone and bupropion, which appears to reflect a fresh trend of weight-loss drugs that are made up of more than one active ingredient, which can make them more efficient and safer.

Combo-pilling may be the newest fad or also the newest into the future under scrutiny and therefore it is just more publicly known lately, comb-pilling for losing weight has been around since the eighties. The biggest reason that employing a combination of pills is now popular is the fact that since right now there are no long term prescription diet pills that have been approved by the FDA other than orlistat. The truly disturbing part is that doctors are prescribing these combinations of medications and some of the combinations are already rejected or have yet to be approved by the FDA.

Seizures certainly are a side effect with Contrave and really should not be taken in those with seizure disorders. The drug could also raise blood pressure levels and pulse rate, and shouldn't be used in people with a history of cardiac event or stroke in the earlier six months. Blood pressure and pulse should also be measured prior to starting the drug and throughout therapy with all the drug.

The FDA also warned that Contrave can raise blood pressure and heartrate and must not used in patients with uncontrolled high hypertension, and also by a person with heart-related and cerebrovascular (circulatory dysfunction impacting the brain) disease. Patients using a history of heart attack or stroke in the last six months, life-threatening arrhythmias, or congestive heart failure were excluded through the clinical trials. Those taking Contrave really should have their heart-rate and pulse monitored regularly. In addition, since the compound includes bupropion, Contrave comes which has a boxed warning to alert physicians and patients towards the increased chance of suicidal thoughts and behaviors linked to antidepressant drugs. The warning also notes that serious neuropsychiatric events are already reported in patients taking bupropion for stopping smoking.

BioCorRx, Inc.'s naltrexone implant isn't bigger than a thumb and is inserted beneath the patient's skin via a 30-minute, noninvasive outpatient procedure created by a medical professional. The implant is administered in BioCorRx, Inc.'s Start Fresh Program which is distributed in several states by independent rehabilitation facilities.

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          Sulfur Dioxide FAQ: Top Reasons Why Harmony House Only Sells Sulfite-Free Freeze Dried Fruits        

This blog will tell you about some of the health risks associated with sulfites and reasons why Harmony House’s freeze dried fruit stays fresh, nutritious, delicious, and shelf stable for years without any sulfur dioxide (or other preservative or additive of any kind).

What is Sulfur Dioxide?

Sulfites, also known as sulfiting agents, are inorganic salts that are commonly used as preservatives by food and beverage producers. Sulfur dioxide is a compound that many dried fruit sellers add to their products to delay spoiling and to prevent them from turning brown on the shelf.

What are the Health Risks Associated with Sulfites?

The US Food and Drug Administration (FDA) classifies sulfites as Generally Recognized as Safe (GRAS). But a small number of people are very sensitive to sulfiting agents. For those who are sensitive or hypersensitive to sulfites, eating even a tiny amount of sulfur dioxide can trigger symptoms that range from uncomfortable to dangerous. When exposed to sulfites, sensitive individuals have been known to suffer a wide range of symptoms including itching, flushing, hives, facial swelling, low blood pressure, gastrointestinal pain, diarrhea, wheezing, asthma attacks, and, in the most rare and worst cases, life-threatening anaphylaxis. Symptoms of sulfite sensitivity usually begin within half an hour after eating food that contains sulfur dioxide.

Who is at Risk?

Children and adults of all ages are prone to sensitivity to sulfites, and sensitivity can arise later in life, even if there has been no history of a reaction at any point earlier. People who have asthma have a higher risk of reaction to sulfur dioxide than those who don’t, however, some non-asthmatics are also at risk. The FDA estimates that one out of a hundred people is sulfite sensitive, and most of them have asthma. Many studies have found 3–10% of people with asthma are sensitive to sulfites, particularly among people with chronic asthma. A number of studies have suggested that 5–10% of all chronic asthmatics are hypersensitive to sulfites. Researchers are not 100% certain of the underlying causes that lead to sulfite sensitivity, though they are certain that it is best for asthmatics and those who have had symptoms of sensitivity to sulfur dioxide to avoid the preservative. All Harmony House dried fruit is completely free from sulfur dioxide, and therefore completely safe for anyone—including those who have asthma or sensitivity to sulfiting agents.

How are Sulfites Regulated by the FDA?

In the 1980s several individuals developed asthma after eating fresh vegetables and fruit that were treated with sulfites. After the cases of asthma were traced back to sulfites, the FDA banned the use of sulfites on fresh fruits and vegetables in 1986. Sulfiting agents, however, have always been legal for use as a preservative in processed food products—though the FDA requires that food manufacturers must list sulfites on the label as an ingredient if their product contains more than 10 parts per million.

How Can I Known if Dried Fruit is Safe to Eat if I am Sensitive to Sulfites?

Always carefully read the labels of any dried fruit before you eat it. If it is from Harmony House, then you know it is safe because we do not use any kind of sulfites in our products.

How Freeze Dried Fruits Stay Fresh Without Sulfites

Chemical preservatives are only one way of keeping dried fruit fresh. Instead of treating our fruit with chemicals, we freeze dry our premium fruit through a safe, chemical-free process that extracts all of the water. Fresh fruit contains up to 90% water. The microorganisms (including bacteria, mold, and fungus) that cause food to discolor and go bad need water to live. Freeze dried food lasts on the shelf for years because the freeze drying process removes all of that water! Here is how it works: The food is placed into a vacuum chamber. The temperature is lowered well below freezing and the pressure is lowered. The frozen water turns directly from a solid (ice) into a gas (steam) without ever turning back into a liquid. The steam is immediately extracted from the chamber. Freeze drying preserves nutrition and flavor and keeps fruit from from going bad for years if stored properly. And you will get almost the same nutrition, flavor, and energy that you would out of fresh!

100% Sulfur Dioxide-Free Freeze Dried Fruit

All of our freeze dried fruit is preserved without sulfur dioxide or any other type of preservatives. You can rest assured that all of our dried fruits are safe for anyone who is sulfite-sensitive. If you have had reactions to any sulfating agent in the past or worry about the possibility that you or someone in your family might have an allergy to sulfur dioxide, you can confidently use any Harmony House freeze dried fruits as snacks or in cooking and baking. A list of our sulfur dioxide-free freeze dried fruits includes:


You can rest assured that we at Harmony House do not use preservatives or additives (including sugar and salt) in ANY of these dried fruits. Our freeze dried fruit is guaranteed to be 100% all natural.


Sulfite Sensitivity from the Cleveland Clinic

Sulfites from the University of Nebraska-Lincoln’s Institute of Agriculture and Natural Resources Food Allergy Research and Resource Program

Sulfites: Separating Fact from Fiction from the University of Florida’s Institute of Food and Agricultural Sciences

          FDA Advisory Committee Votes Against Approval of Eteplirsen; Coalition Duchenne Comments        

Coalition Duchenne Founder and Executive Director Catherine Jayasuriya Reflects on the Recent FDA Advisory Committee Meeting on Eteplirsen

(PRWeb April 29, 2016)

Read the full story at http://www.prweb.com/releases/2016/04/prweb13380374.htm

          Coalition Duchenne Advocates for FDA Approval of Eteplirsen        

Coalition Duchenne is attending the April 25 U.S. Food and Drug Administration advisory committee hearing on the efficacy of the Sarepta Therapeutic’s novel Duchenne drug eteplirsen.

(PRWeb April 24, 2016)

Read the full story at http://www.prweb.com/releases/2016/04/prweb13365975.htm

          US FDA attracts former adversaries        

The US Food & Drug Administration has recruited one of its own long-standing critics, hiring Peter Lurie from the watchdog Public Citizen as a policy adviser. That suggests a more enlightened approach from the regulator under Margaret Hamburg, the new commissioner named by President Barack Obama.But what is good for goverment is bad for independent scrutiny. Earlier this year, the agency hired Sidney Wolfe, another vocal critic from Public Citizen, which must now be reeling from the departures. Who will be left to provide commentary and outside analysis?

It all tastes less of poacher turned gamekeeper than of gamekeeper poaches critics.

          Viora’s Receives CFDA Approval for Reaction™, Multi-RF Technology Bi-Polar Device in China        

Certification Allows Chinese Physicians Access to Reaction, a Leading Aesthetic Solution Provider for Skin Tightening, Body & Facial Contouring and Cellulite Reduction Treatments

(PRWeb May 28, 2015)

Read the full story at http://www.prweb.com/releases/2015/05/prweb12749728.htm

          Viora’s V-20 Multi-Technology Platform Receives FDA Approval        

New Medical Aesthetic System Driven by Innovative and Advanced PCR™ & CORE™ Technology

(PRWeb December 02, 2014)

Read the full story at http://www.prweb.com/releases/2014/12/prweb12365050.htm

          Viora’s V30 Multi-Technology Platform Receives FDA & CE Certifications        

Innovative Laser, IPL and RF Technology Device Is Now Cleared for Marketing Worldwide

(PRWeb May 08, 2014)

Read the full story at http://www.prweb.com/releases/2014/05/prweb11836049.htm

          New Certifications Received in APAC Market for V-touch, Viora’s Fractional RF Device        

V-touch™ receives Taiwanese FDA, Thai FDA and South Korean MFDS Clearance for Fractional RF treatments.

(PRWeb April 08, 2014)

Read the full story at http://www.prweb.com/releases/2014/04/prweb11742007.htm

          New Pets Column Now Live        
I'm happy to report that I am now writing a monthly column about Pets for Prevention magazine. An editor at the magazine contacted me after reading this article I wrote about my dog Bonny plus several animal-related posts on this blog -- she suggested I combine my love of animal stories with my decade of experience as a veterinary technician to write a regular series for Prevention (which I thought was a fabulous idea).

My first column just hit stands in their June issue (now available in grocery stores everywhere) -- it's called "Feeding Disorders," and it was inspired by this post about pet obesity, which I wrote when the FDA approved a crazy new diet drug for dogs (interestingly, that is one of my most widely read posts, perhaps in part because of the amazing photograph I posted with it).

Stay tuned for more columns, which I'll post here each month as they run. And feel free to email me any tips or suggestions for future columns.
          A Sad Day: FDA Approves First Dog Obesity Drug        
The FDA just announced that they've just approved the first-ever obesity drug for dogs, which really makes me cringe. Why? Because dogs don't have eating disorders -- their owners have feeding disorders.

This summer, I adopted a new dog after she ran in front of my car on an interstate. She was starved, so I took her home and fed her. And fed her. And fed her. She weighed 20 pounds and could eat a heaping cup of food in 28 seconds (yes, I timed her). But that was fine, because she needed all the extra calories she could get. Then, about three months later, during a good wrestling match, I realized I couldn't feel her ribs anymore. Suddenly, she'd gone from being emaciated to being pudgy. So I did exactly what everyone else with a pudgy dog should do: I started feeding her less. Instead of getting a heaping cup at each meal, she got 2/3 of a cup. Three weeks later, she wasn't pudgy anymore. That's the amazing thing about dogs and weight: Humans control their calorie intake, and there's nothing dogs can do about it. If your dog needs to lose weight, you feed it less food.

It's true that there's an epidemic of canine (and feline) obesity right now, just like there's an epidemic of human obesity. Which is no coincidence: People don't exercise, which means their dogs don't exercise. When people eat, they feed their dogs scraps, so the dogs gain weight right along with their owners. And don't even get me started on the ingredients in dog food.

But there are other less obvious problems: Owners often have no idea how much they should feed their dogs, and if they follow the guidelines on most dog food bags, they're probably going to have obese dogs, because pet food companies encourage overfeeding. I had a 125 pound dog who lived to be 16 and was never an ounce over or under weight. If I'd followed the guidelines for his food, he'd have eaten 2 1/2 times what I actually fed him, and surely become obese. My very healthy 17 year old dog Bonny eats 1/4 the recommended amount, always has.

During my years as a veterinary technician, I saw many dogs die or become paralyzed from obesity. Today, when I see an obese dog on the street, I want to walk up to its owner and say, You love your dog, right? Then why are you killing it?

If it's come down to this, and people are unable to control themselves when it comes to feeding their dogs, I'd rather see dogs medicated than dead. But I hope vets who prescribe this stuff paste a sticker on every bottle that says, Dogs don't need obesity drugs. They need owners who will feed them the right amount, cut back when necessary, and make sure they get exercise. (Perhaps the FDA should consider a self-control drug for humans with dog feeding disorders.)
          Xóa xăm vÄ©nh viễn công nghệ Laser Toning 8X        
Laser Toning 8X là công nghệ laser Æ°u việt, hiện đại trên thế giới loại bỏ triệt để vÄ©nh viễn các loại hình xăm với mọi màu sắc, kích thước, độ nông sâu, đâm nhạt khác nhau được FDA chứng nhận hiệu quả và an toàn. XÓA XĂM VĨNH VIỄN CÔNG NGHỆ LASER TONING 8X … Continue reading Xóa xăm vÄ©nh viễn công nghệ Laser Toning 8X
          Adult Body Painting - What's the Fuss About?        

Did you ever want to be a cowboy? Maybe a rain forests? What about trading your skin in to become a seductive tigress ready to pounce on fresh meat? Well, whatever your adult fantasy may be, adult body painting may be the temporary and fun solution.

Though this art form has been around for centuries, many people haven't tuned-in to this creative outlet. Some people claim that body painting is actually the oldest art form (Considering that people were painting their bodies pre-anno domini. Just think of early century Egyptians). And, with adult body painting companies and artist all around the globe, one would probably have little difficulty finding an artist close by.

Adult body painting is an art that uniquely transforms your everyday skin into a beautiful picturesque scene or life form. How? Glad you asked. By using safe, FDA approved make-up, oils, and other various paints and applying it directly to your skin. Any part of your skin. Oh yes, that's right, any part. Body painting artists are extremely professional and willing to cover any part of your body that you so desire, from head to toe. Or, if you can't make your mind up on which body part to paint, you can have your entire body brushed with a plethora of colors that completely disguises the real you underneath. Unless, of course, you really are Smokey the Bear. Which can be done. By method of airbrushing, painting, and drawing, your body can soon be entirely transformed into your fantasy.

          How Gluten Causes Alopecia Areata        
Do you recognize this circular hair loss pattern? It is called alopecia areata. According to the National Alopecia Areata Foundation, “no FDA approved treatment or cure exists yet.” No cure, eh? It is amazing how many times I hear this “no cure” declaration when I KNOW people who have been cured of the condition in ...
          HeartIT Receives FDA 510(k) Clearance for Wider Clinical Indications        
August 17, 2016 – Heart Imaging Technologies,LLC (HeartIT) today announced that the United States Food and Drug Administration (FDA) has issued a new 510(k) clearance for HeartIT’s products, FDA 510(k) Number K152949. The new clearance states that HeartIT’s software products “can be configured with different combinations of clinical applications which are intended to assist the physician in diagnosis or treatment Continue Reading
          FDA Approved Temodar        

The U.S Food and Drug Administration's approval of Temodar as a treatment for people newly diagnosed with glioblastoma recognizes the importance of hope. These reports signify movement in the treatment of one of the most aggressive brain tumors.

(PRWeb March 16, 2005)

Read the full story at http://www.prweb.com/releases/2005/03/prweb219054.htm

          [Sponsored] ClearSK Laser SHR Hair-Free        
I always have issues with keeping my under arm hair-free, but that's impossible with just shaver. Especially that is an action that you have to do everyday. Waxing is out of question since it does hurt (I guessed). The other alternative is to go for Laser SHR and ClearSK has the solution to solve the hair issue that we have been all worried about.

Their Laser SHR Hair-Free is their latest treatment for ladies who have no time to spend on shaving or scare of pain.

Lasers and light sources use the principle of selective photothermolysis to eliminate hair and its potential regrowth without damaging the surrounding skin. During ClearSK Laser SHR treatment, light passes through the skin and is absorbed by the melanin in the hair shaft. This absorption raises the temperature of the hair follicle and thermally destroys the cells responsible for regrowth.

Clinically-tested by US FDA for safety and efficacy, this treatment is suitable for all hair types (from thick to fine) and skin tone (light to dark). Highly comfortable for bikini line and Brazilian hair removal too.

So i was offered a session of Laser SHR Hair-Free treatment at Novena Medical Centre. And was ushered into the treatment room once I've reached as I reached on the dot for my appointment. *haha*
This is the machine that is used for the treatment, the applicator is rather small for a big machine.
This is a pic before my treatment, basically I didn't really shave for the treatment. The consultant had to do a little shaving before the treatment (my bad).
Cooling gel applied
A layer of cooling gel is applied on the area before the session. It's a little similar to the LaserSlim Treatment, a cooling gel is applied before the applicator is used. Then my consultant started to use the handpiece and I felt a slight warm sensation but it was not painful at all. The handpiece is to deliver continuous repetitive pulses of light. 
After treatment
Pardon for the blur photo, but it was taken right after the treatment. Not really hair-free but most of the hair were gone and basically can't even see the tiny heads like I do see after shaving ( either that I really suck at shaving).

After treatment, I applied moisturizer as I felt a little dryness over that area. And after a month, I do see even after a session of Laser SHR Hair-free treatment, the hair growth is minimal! This is amazing. Their recommended sessions to see optimal results is a minimum of 6 weeks and once per month. For hairier people, they recommend up to 10 sessions.

Hair reduction is observed after 4-6 sessions. Hair is evidently finer. For those with less serious case, the treatment causes permanent damage to the hair follicle and hence the results will be permanent.

SHR Hair Free treatment targets the deeply seated hair follicles and permanently damages them as opposed to shaving, waxing, hair removal creams which only serve to remove the hair shaft. Unless you have gone through hormonal imbalances caused by pregnancy, menopause, intake of hormone pills, most people enjoy permanent hair reduction/removal.

The 1st trial treatment is 20 minutes at the price of $68 each. They have outlets at Scotts Medical Center, Novena Medical Center, Velocity, Orchard, Tampines, Jurong East. They have an outlet at the different parts of this sunny island to cater to their customers.

You can visit their website for more information: http://www.clearsk.com

          Center For Women’s Care & Reproductive Surgery Launches FDA Trial of Olympus Narrow Band Imaging to Detect Endometriosis; New Technique May Improve Diagnostic Ability        

"About four-fifths of endometriosis patients do not display symptoms,” said Tom Lyons, MD, a pioneer in gynecologic laparoscopy and co-author of WHAT TO DO WHEN THE DOCTOR SAYS IT’S ENDOMETRIOSIS (Fair Winds Press).

(PRWeb June 30, 2011)

Read the full story at http://www.prweb.com/releases/2011/6/prweb8608436.htm

          Center For Women's Care Offers Fibroid Treatment New To Atlanta, FDA Says Proven Noninvasive Ultrasound Treatment Offers Significant Advantages        

The latest medical technique to treat fibroid tumors, exablation, also known as MR-guided focused ultrasound (MRgFUS), "offers significant advantages over existing treatments for uterine fibroids," says the FDA. The incision-free fibroid tumor treatment that destroys tumors with high-energy sound waves is now available in Atlanta. Unlike Uterine Artery Embolization (UAE) or Uterine Fibroid Embolization (UFE), the FDA says the treatment is "not contra-indicated in women who may be seeking pregnancy in the future."

(PRWeb April 15, 2008)

Read the full story at http://www.prweb.com/releases/2008/04/prweb852654.htm

          Clinical Trial On Dysfunctional Uterine Bleeding (DUB) Now Conducted by Thomas L. Lyons, MD, GYN Surgeon        

The Center for Women's Care & Reproductive Surgery, headed by laparoscopic pioneer Thomas L. Lyons, MD, is conducting a placebo controlled FDA clinical trial on a drug used to control dysfunctional uterine bleeding (DUB). Women who experience heavy menstrual bleeding on two to five days of their cycle, and who have to alter their normal social and work activities due to heavy bleeding may be qualified for the study. Women must be generally healthy, and between the ages of 18 and 49, have regular menstrual cycles with heavy bleeding and not have any other bleeding disorder.

(PRWeb July 24, 2007)

Read the full story at http://www.prweb.com/releases/2007/07/prweb541552.htm

          1/10/04 HURRICANE & the making of "Lost in New Mexico"        
The naturally talented David Paytiamo (left, who played Lonnie), filmmaker/director Jason Rosette (center, who also played FDA Agent Carl Wisconsin), and the improvisationally gifted Dale Waseta...

Check out the Blog for LOST IN NEW MEXICO (The Movie) for complete info & updates!

          Reed Tech Announces FDA Lot Distribution Report (LDR) Service for Manufacturers of Biologic Products        

Efficient and cost-effective, the Reed Tech LDR solution enables biologics and vaccine manufacturers to prepare required periodic distribution reports and successfully meet new regulatory challenges

(PRWeb April 17, 2015)

Read the full story at http://www.prweb.com/releases/2015/04/prweb12662585.htm

          Off Base Percentage World Series Predictions         
Sup? Sup. /head nod Suuuuuuup.

Here we are. It's the middle of October, and baseball has now finally widdled itself down to its final two teams. As all the experts predicted, the Royals and the Giants will square off on Tuesday to kick off the 111th World Series. What? No one predicted this World Series matchup? OK, maybe they didn't. But, now that we are here, who is really upset about this matchup? That's right. Nobody.

In advance of the Fall Classic, the Czar of Off Base Percentage, MJ Lloyd, and myself are going to kick around the old question ball and see if we can come to a consensus on who will be standing victorious at the end of the World Series. We put on pants for this shindig, so you would know that we mean business. Well, MJ is wearing pants. I'm wearing Spongebob Squarepants pajama pants. But for this exercise, they count as pants.

Let's cut to the chase, MJ. Ned Yost. Micro-managing genius, or insanely lucky? Side thought: How much does the ghost of Dale Earnhardt have to do with the Royals insane winning streak in these playoffs?

It's funny that Ned Yost was your first question because that was going to be my first question. But more of an over/under on when he calls for the first bunt of the World Series and I imagine it comes during media day. "Eric, you've been hot but as soon as somebody asks you a question with a runner on, you square up that mic and put it down the right exit hallway."

I don't think he's been lucky or good. He realized he needs his starter for five or six innings and if they have a lead, they win. I'll give him credit for using some of those guys for multiple innings but, oh god, Dayton Moore did a fine job giving him a bullpen that can win a championship.

And maybe the ghost of Earnhardt has played a role with the Royals. It's a nice story. Maybe Ned is hearing whispers of "go faster" when he sends everybody running on the bases. That would explain why Dyson gunned it so hard (20.1 mph) he slid past second into left field.

While I'm sure I know the answer long suffering Royals fans would give, I'll ask you. Is the Royals winning the World Series worth another 10 years of Ned Yost and Dayton Moore? Flags fly forever and sac bunts only drive you crazy for 162 games a year.

Worth it? To the outsider, probably not. But for fans, a World Series hangover can last for a long time. Of course, Ned Yost's wacky and zany land of small ball antics will only be endearing for as long as it is working. And I believe that the expiration date for this product is coming up pretty soon. But, to be fair to Yost, Joe Torre was considered a terrible manager before he got hired to manage the dynasty that was the late 90's Yankees. So, for Yost, who knows. Maybe he has finally found his place in KC. But, at this stage, I'm banking on the smoke and mirrors wearing off sometime around March of 2015.

Whatever crossroads both Yost and Moore went to in order to hook up with Robert Johnson and his genie of dark magic, they need to share it's location. I'm not saying that it is a good idea to sell your soul to the Devil, I'm just saying that maybe its not as bad of an idea as I originally thought.

Jarrod Dyson's hair? Fun and quirky oddity of this year's playoffs, or an undeniable cry for help?

Fun and quirky for sure. You've never had some strange choices in hair? When I was in my early 20's, my spikey hair color changed every two weeks and I had designs in my facial hair that would impress Jeff Hardy.

Dyson has one big job for this Royals team. Run fast. So, he chose to shave "Zoom" into the side of his head. If they win the World Series, Dyson's agent better get Mazda on the phone.

Speaking of agents getting on the phone, if the Giants win, what else would Buster Posey have to do to be the face of MLB? Seems like he should be a bigger star.

I had a rat tail at one point, and in recent years I've been rocking the mullet with a receding hair line. So, yes, I have enjoyed strange hair style choices. Maybe I should take it easy on Dyson.

Posey on the other hand, could probably use a bottle of my newly created and recently patented (but still not FDA approved) elixir, Be Less Boring. Posey is a wonderful player, and an excellent catcher. But, my goodness, is he boring. Without being a flashy star like some of the other big names in the game, he needs to do something. Maybe start compiling a rap sheet, or buy drinks for the entire bar after a series win a la Eric Hosmer.

Say you are walking down a dark alley in some seedy neighborhood in a scary city in America, who would you rather not run into in this situation: Hunter Pence, Michael Morse or Eric Hosmer? Why Hosmer, you ask. Have you heard him yell things?

Can I choose Pablo Sandoval if he wasn't smiling? If I ran into him in a dark alley of a shady neighborhood, I'd assume he was a bodyguard for the local mob leader. Plus he knows Kung-Fu, or so I've heard.

And if I was trying to get into a club, I wouldn't want to run into Madison Bumgarner. He doesn't give free passes this time of year.

Are you impressed by my boy MadBum yet?

Yes, I am. And not just because his snot rockets are monitored, charted and tracked (I hear his velocity on boogers is up from last year. Worth keeping an eye on). He's just good at everything on the mound. He also has great hair and wonderful facial hair. But I'm still not upset that I left him off of the ballot for the Walter Johnson Award.

Everyone made a big deal about the Royals being last in the known world in hitting dingers in 2014. However, the Giants hit exactly zero dingers until game five of the NLCS in this year's playoffs. With all of the media fawning over what is happening with regards to the Royals, is it possible that the media is missing out on a team that is out-Royalsing the Royals?

Could be. Eric Hosmer and Mike Moustakas were highly regarded prospects. So, maybe their monster shots in extra innings were just more exciting than Michael Morse and Travis Ishikawa? The Giants at least hit 132 homers during the regular season. The Royals finished dead last and didn't break 100. That makes the recent power surge a talking point for anybody trying to make a deadline. Speaking of which...

Let's start making some predictions. There's always an unlikely hero in the World Series. I know David Eckstein actually won a WS MVP but I want to call this the Eckstein anyway. That makes my pick David Eckstein. Wait, I mean Alcides Escobar. Who you got?

I'm putting my collection of George Washington's on Alex Gordon. It'll be the perfect ending to this KC masterpiece when the team's longest tenured, and former hotshot prospect, carries this band of crazy midwesterners to their first title in 29 years.

I assume that since you are picking Escober to take home the Eckstein that you are also picking the Royals to win the series. Is that correct?

You would think, right? I love that Royals bullpen and them in six sounds awfully tempting. But if I've learned anything since 2010, it's that Lindsay Lohan is never going to get her shit together. Also, the Giants win the World Series in even numbered years. I'll take the Giants in seven with Madison Bumgarner winning three games and the actual WS MVP.

Your final prediction?

Royals in six. Cut, print, on to the next scene. Their bullpen has made each game a five-inning affair, or it has been able to keep the opposition down for five innings of free baseball. They also have history on their side. The only other time that two Wild Card teams met in the World Series, the American League team won. This matters because, who really cares about sample size? Either way, it is going to be a really fun series that I am sure will cause 30-year old men in Kansas City and San Francisco to lose at least a solid inch of hair from their hairline.

Best of luck to the Gigantes and the Monarchs. To the fans: Stock up on antacids. All the antacids.
          FDA Finally Issues Some Biosimilar Guidance Documents        
The US Food and Drug Administration finally released portions of the long-awaited guidance documents that will help to implement the development and approval of biosimilar molecules under the Biologic... click here to continue
          Regulatory Affairs Update; FDA 483 and Warning Letters Trends for 2012        
Those of you who manufacture products approved by the US Food and Drug Administration (FDA) are well aware of the importance of complying with Current Good Manufacturing Practices (cGMP) during FDA ma... click here to continue
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          Bioidentical Hormones and The Wiley Protocol Testimonies        
Bioidentical Hormones: Its Dose Dependency and Duty for Hormone Receptor Reaction

There's this little FDA approved drug named estrazorb and it's a small kechup sachet filled with soy oil and estradiol. It comes in 4.3mgs. and you are meant to have it twice a day. That is's 8.6 mgs, the basic dose on the Wiley Protocol. Okay. It never goes past that except for 2 days. We are within the range of FDA but nobody notices it. Even with an FDA merchandise you can't expect to get benefits from right away. Without peaks and valleys, without differential drops and high amounts, you can't reset receptor response and it's not how much you take, its how much receive.

So, without those receptors falling into line and making this work in a normal way as it might in a normal young woman. You are not having hormone re-establishment. You barely have replacement. I attempt to make them understand that bioidentical hormones are dose reliant in their effects. This much does one thing, this much does another thing. So, they understand that without that peak on day 12, you have got steady proliferation in any static dose of anything.

Estrogen converts it on the twelfth day. It's a negative feedback loop. Hormones are efficient same as endocrinology both on positive and negative results and with no high level on the twelfth day, not only will it put a stop to estrogen but also it will not permit the progesterone receptor to accept progesterone in the second half batch.

I'm not sure it is very clear in the literature. Isn't it just common-sense that after you eventually studied molecular biology that both progesterone and estrogen creates its own *** by making another receptor for the progesterone. And that is just negative cycle. Negative feedback loop to turn itself off. *** on arrest or just expansion stopping on day twelve is not enough.

He will have to disengage from the procedure. So you turn off the receptor energy amd then deactivated. Then you turn off the estrogen. All of these ladies who've been robbed, who have lost their uris, the gynecologist who prescribes static dose hormones, and then get to perform surgery later.

That is where ladies take a pause in this nation. Infrequently they are stuck on them, even in such an inexpensive manner. They're known as iatrogenic but am not so sure of the rationale why. They're stuck. They are not of the same field in endocrinology. The endocrinologist wont be in a position to cure menopause. Endocrinologists are put in drugs to address diabetology and thyroid and infertility. They're dealing with hormones.

They have incorrect interpretation of men having andropause and women having menopause as having none whatsoever. So they are not being treated. They just have faith in what these doctors say because these doctors are also knowledgeable in medicine. They assume they could modify some things but they cannot.

Dr. Fred Bloem Question and Answer

Medical practicians have come across a discovery that is pliable for the enhancement of finding and healing the patients. Then they take that knowledge and use it to those in want.

My name is Dana Gillian together with Dr. Fred Bloem, a physician with an expertness in the area of family and internal medicine. He thinks in a holistic medical practice involving bio-identical hormone replacement therapy, weight decrease therapy, nutrition, vitality healing and some raw food instruction. He practices in Olney, Maryland. So, you attended the two days back on earth seminar. What is the important information you've extracted from that symposium?

Dr. Fred Bloem:
There are 2 essential things. One was seeing T.S. Wiley prior to coming to Santa Barbara. I came to hear about her through Susan Somers' book Ageless and her own "Sex, Lies and Menopause." But, meeting her was really impressive. Seeing her made it possible, I had learned about her through another physician that I spoke with before making the conclusion to come to Santa Barbara. So, I knew that she was very intelligent. I was not disappointed when I came to Santa Barbara. She has a wealth of knowledge on the topic of internal secretions and related physiology. That is why I am glad to have listened to her.

Another thing that was very central to me was validation. Convening with the other physicians from all over North America who generously contribute their views and testimonies.

With your own experience, what is the most essential positive answer given to women who undertook the Wiley Protocol?

Dr. Fred Bloem:
The very important aid is the aid on their common issues. Some of these include hot flashes, insomnia sweating during nighttime. Another, one is less feasible but the ability to regain their femininity.

Is there any distinct story of your patient who undertook the Wiley Protocol?

Dr. Fred Bloem:
Yes, I would be happy to share with you an example of a patient who's been very successful on the Wiley Protocol. She was 45 years old when she came to me last year. She consulted me for a weight loss treatment. But as I met with her, I discovered that she was actually born without a left ovary and she only had a little right ovary. And because of that she never got to experience having menstrual periods, the only time she did have was once when she was given Premarin and birth control pills.

She shared with me that for a long time she was angry because she was not able to have kids. She disliked her body type. Her chest was a bit slight. All her life she's been misery and so I recommended the Wiley Protocol and recounted to her some of my patients' experience. She had the process since last June and she felt positive effects in just one month. She shared with me that she had more vitality. She shared that her body felt weird and felt that the hormones altered the shape of her body. She noted that her breasts became fuller within the first month and she also felt that the heaviness and this is actually a way how she identified her feelings of depression that feeling of heaviness vanished.

She also said that her rest pattern bettered and totally feels contented. And one of the things that she shared with me also which I found was very interesting was that she never felt womanly. She always felt more butch. She was joyful to tell me that Wiley Protocol made her feel like a actual woman again. I thought that was very interesting. Most of my patients really feel the distinct switch when they begin the Wiley Protocol. The Wiley Protocol has been an significant facet of my medical practice.

I really consider myself really lucky that I have been introduced to this protocol indirectly through my patients by their sharing Susan Somers book Ageless with me. It really makes a lot of sense to me. I have been recommending bioidentical hormones replacement therapy for more than six years and have had in mind as to how much is the proper dose of Estradiol and Progestrone for my patients and whether to use Estradiol or Biased and just how long should I be giving it in sessions.Should I organize it with a ***4:47? I was really bewildered about things like that and I really didn't have a good understanding of the lab follow up in terms of what the right dosages of Estradiol and Progesterone should be for women at any particular time in the cycle. And so getting acquainted with the Wiley Protocol is really significant for me.

We replace Estradiol and Progesterone and we observed a pattern that we see in healthy young women and so we know that Estradiol, sometimes it should be low in the cycle and sometimes it should be high on day twelve. Progesterone throughout the follicular stage and gradually build up through the luteal stage, highest level is at 21 and it goes down. And I found that that is really the optimal way for women, young and old, to place their internal secretions and it does not matter whether they're you know perimenopausal or post-menopausal or whether they're younger. In my years of medical work, I found that some young women also encounter problems with regards to menstrual period. And that is an indication that their Estradiol and Progesterone secretion is not harmonious.

Dr. Mitchel Fleisher Sees Dramatic Results in Auto-Immune Illnessees With Wiley Protocol

My interest in it is having the ability to combine this very accurate rhythmic bioidentical hormone therapy with constitutional homoeopathy which is you've got the bio-energetic kick, specific bio-energetic kick on a mind, body, spirit plane together with biochemical, bio-hormonal kick and bringing in both in the balance ideally to realize perfect health and well being. And I'm actually anticipating interfacing with other doctors who're using this protocol and standardizing it so we actually, actually know what we're doing and having the ability to have a definitive protocol to work by that everybody's using at the same level and gather enough research ad clinical info that we can present it to the medical profession and to the govt. and say hey, this is the way to go.

This is the way to be in a position to deal with lots of protracted sicknesses we have not been in a position to master. I have heard stories of some of my co-workers in Texas and other states who've been treating patients with dreadful autoimmune illness diseases, rheumatoid arthritis, lupus, multiple sclerosis that they put them on the Wiley Protocol and they saw amazing results. I help patients with illnests with the use of the Wiley Protocol and I'm excited to mix it with homeopathic nutritive that may be good for all.

A Testimony on Wiley Protocol by Julie and Ola Johnson

The common problems that are being complained by most women are the hot flashes, sleeplessness, head blurriness, different aches and the feeling of not being alive. I did have the mind fog. I had insomnia. I didn't experience hot flashes but there were so many other problems I had and after staring the process, I felt that I was back once more.

PYou know, I felt reconnected to everything and everybody and I had balance again.|I felt I had regained all that I have lost and felt the balance.} And when you are of this age, you know you are 50s, you are sixties, you've got a lot of issues to handle in your family immediate and otherwise. And I wasn't coping well you know and then when I kept balance again, I was able to actually get a grip of everything and I got my life back basically.

When she had not had the process yet she used to have all kinds of the issues and signs during menopause and could not absorb well because of the mind blurriness and most of all a little grouchy. After going thru the Wiley Protocol, she somewhat turned back to her ld self again and our sex life hasn't ever been better. She regained her old self again and our regular lives went on to be better and we appear to be always in high spirits. So, I'm totally happy with her being on the protocol, naturally.

If you do not resolve anything and will not take the hormones then you get ill. You die. When you go have hormones, you experience a better feeling. You have a great reaction. In some rare instance, you feel ecstatic. And when you do feel better, it's a sign that it is good for you. So, I suspect the fear thing is very over blown by maybe the media, maybe by other people that have no idea but you have to have the experience. You need to try it. You've got to do your own research and then go by how you're feeling and you look. You don't end up running out of step drugs in your system or arthritis drugs or sleeping pills. There is just a sense of hollowness within once the hormones are imbalanced. So, when you replace them, you know you basically get your life back.

The Wiley Protocol

Year after year A4M, the world's greatest anti aging establishment organize global seminars. So we took out cameras on the show hall grounds to offer you an idea about what are the latest in the anti aging marketplace.

The Wiley Protocol is a multi-phasic rhythmic dosing schedule for bioidentical hormones to be provided to women in a bio-mimetic way to mimic biology. Nobody has tried doing this before. WE started the transdermal estrogen and progesterone in a manner that it cpies the usual sequence of a young female in her twenties. Then we give explanation for the quantity of dose to be given with the aid of serum blood levels on the twelfth day and 21 to make sure if she turns out to be the 20 year old she was before. It is very profound because young women still have no trace of various sicknesses. So, when we put women back, we actually restore their hormone. We don't just treat the signs and we know that those young women are healthier in every way.

The delivery system is simple. We use 3ml syringes color coded, purple for progesterone, green for estrogen, and the women that way don't pick up the inaccurate syringe in the middle of the night when they're putting on their hormones and take the wrong thing. One of the reasons why the federal authorities wants to eradicate the bioidentical hormones is that they are constituted and made in so many manner. We have governed the means, the substance, the tagging and dose measure so they can be used for research. You can visit our website www.thewileyprotocol.com. In there you will see all the information you need including the practicing physicians.
          How Menopause Symptoms and Sleep Benefit From The Wiley Protocol As Proven By Experts        
The Hormone Receptor Reaction Obligation and Dose Dependency of Bioidentical Hormones

There's this little FDA authorized drug named estrazorb and it's a little kechup sachet full of soy oil and estradiol. It comes in 4.3mgs. and you are meant to have it twice a day. That's's 8.6 mgs, the basic dose on the Wiley Protocol. Fine. It must not exceed within 2 days. We are inside the range of FDA but nobody notices it. Even FDA products, you cannot treat somebody and get any effects immediately. Without tops and valleys, without differential drops and high doses, you can't reset receptor response and it isn't how much you take, its how much receive.

If receptors don't fall in its right places and not having the ability to work in the usual demeanour like it should have been in younger women. You do not have hormone restoration. You hardly have replacement. I try and make them see that bioidentical hormones depend on dose's result. This much does one thing, this much does another thing. So, they know that without that top on day 12, you have steady proliferation in any static dose of anything.

Estrogen turns it so far on day twelve. It is a damaging result circle. Hormones are effective same as endocrinology both on positive and negative results and with no high level on the twelfth day, not merely will it put a stop to estrogen but also it won't allow the progesterone receptor to accept progesterone in the second half batch.

I do not know it is very clear in the literature. Isn't it just common sense that after you ultimately studied molecular biology that both progesterone and estrogen makes its own *** by making another receptor for the progesterone. And that's just negative cycle. Negative feedback loop to turn itself off. It is in steady motion or stop the expansion on the 12th day.

He will have to disengage from the procedure. So you switch off the receptor energy amd then deactivated. Have all of the receptors turned off. So for those girls undergoing the treatment,that already is the validation to make it function better.

Here's where girls are stuck in this country. They're stuck taking something that basically makes them worse. They're called iatrogenic but am not so sure of the explanation why. They are steady. They are not endocrinologists. The endocrinologist won't treat menopause for women or andropause for men. Endocrinologists are put in medication to deal with diabetology and thyroid and infertility. They are dealing with hormones.

They perceive folks in andropause and menopause not to have any. So, they don't treat them. They just fall thru the cracks because endocrinology could step in here and there may be menopause medicine. They think they could change some things but they cannot.

Dr. Fred Bloem Question and Answer

Medical practicians have come across a breakthrough that is pliable for the enhancement of determining and healing the patients. Then they take that cognition and give it to those in need.

Hello, I'm Dana Gillian and I'm speaking today with Dr. Fred Bloem, a physician with a background in family and internal medicine. He thinks that bio- identical hormone replacement therapy, wait reduction therapy, nutrition, energy curing and other raw food lesson constitutes to the holistic medical practice. He operates in Olney, Maryland. So, you attended the two days back on earth seminar. What is the important info you've drawn from that symposium?

Dr. Fred Bloem:
Well, really 2 things. One was seeing T.S. Wiley prior to coming to Santa Barbara. I had only learnt about her through Susan Somers's book Ageless and through her book "Sex, Lies and Menopause." But, meeting her was really impressive. Seeing her was a validation because I had spoken with another physician before thinking of coming to Santa Barbara. That's how I came to know of her intelligence. I was not unfulfilled when I came to Santa Barbara. She has a huge storage of info regarding internal secretions and physiology. That is why I am happy to have listened to her.

Another thing that was very central to me was validation. The chance to meet other physicians from all across North America who shared their insights and success stories.

With your own practice, what is the most essential positive answer given to women who undertook the Wiley Protocol?

Dr. Fred Bloem:
The very important help is the aid on their everyday issues. Examples are easing of hot flashes, night sweat problems, sleeping problems with memory palpitations in several instances. Another, one is less tangible but the ability to regain their femininity.

Can you share any particular experiences of patients that have experienced dramatic results or any especially unforgettable patients you have had from the Wiley Protocol?

Dr. Fred Bloem:
Yes, I would be willing to share with you an example of a patient who's been very successful on the Wiley Protocol. She was forty five years old when she came to me last year. She came to me for weight reduction therapy. But as I met with her, I discovered that she was in reality born without a left ovary and she only had a little right ovary. So, for that reason, she never got a menstruation and in reality the first time that she did get a menstruation was when she was 18 years old and she was granted Premarin and birth control tablets.

She told me that she was unrewarded for the longest time for not able to have babies. She didn't like her body type. She had smaller breasts. All her life she's been woeful and so I recommended the Wiley Protocol and recited to her some of my patients' experience. She had the process since last June and she felt positive results in just one month. She shared with me that she had more vitality. She told me that somehow she felt that the internal secretions have modified her body. She noticed that her breasts became plumper within the first month and she also felt that the heaviness and this is in reality a way how she described her feelings of clinical depression that feeling of heaviness evaporated.

Also, she felt that her slumber was much improved and just felt very comfortable overall. And among the things that she shared with me also which I found was very interesting was that she never felt womanly. She had that feeling that she was more similar to a man. She was really charged to share with me that she was just observing now what it was like to be a female since beginning the Wiley Protocol. That was just so extraordinary. I have patients like that, not precisely like her but patients who experience a tremendous transformation when they start the Wiley Protocol. The Wiley Protocol has become a very significant part of my practice.

I really see myself really lucky that I have been introduced to this protocol indirectly through my patients by their sharing Susan Somers book Ageless with me. It really makes plenty of sense to me. I have been offering Bio-identical hormone replacement therapy to my patients for about six or seven years starting with statically dosed bioidentical hormones replacement and from the very start, I always wondered what is the right dosage of Estradiol and Progesterone for my patients and should I use Estradiol or Biased and for how long should I use it in the cycle.Should I synchronize it with a ***4:47? I was really baffled about things like that and I really didn't have a good understanding of the laboratory follow up in terms of what the right doses of Estradiol and Progesterone should be for women at any particular time in the cycle. And so getting acquainted with the Wiley Protocol is really remarkable for me.

We substituted Estradiol and Progesterone and observed a sequence seen in healthy youthful women and now we discovered that Estradiol should be low in dosage and must be high on the twelfth day. And Progesterone is low during the follicular stage and it slowly rises during the luteal stage, peaks only at 21 and then goes down. I discovered that it is the most possible means for women to put their internal secretions whether they are young or old. In my years of medical profession, I discovered that some young women also encounter troubles with regards to menstrual period. And that is an indication that their Estradiol and Progesterone secretion is not well-balanced.

The Outstanding Effects of Wiley Protocol in Different Illnessees by Dr. Mitchel Fleisher

My interest in it is having the ability to combine this very accurate rhythmic bioidentical hormone care with constitutional homoeopathy which is you've got the bio-energetic stimulation, particular bio-energetic stimulation on a mind, body, spirit plane together with biochemical, bio-hormonal stimulation and bringing in both in the balance ideally to gain perfect health and well being. And I am really anticipating interfacing with other physicians who're using this protocol and standardizing it so we really, really know what we are doing and having the ability to have a conclusive protocol to work by that everyone's using at the same level and gather enough research ad clinical info that we can present it to the medical profession and to the govt and say hey, this is the way to go.

This would be the best demeanour in working with other illnesses that we haven't mastered yet. I have heard anecdotes of some of my co-workers in Texas and other states who've been treating patients with dreadful autoimmune disease sicknesses, rheumatoid arthritis, lupus, multiple sclerosis that they placed them on the Wiley Protocol and they found dramatic results. I help patients with illnests with the utilization of the Wiley Protocol and I am excited to combine it with homeopathic nutritional that would be good for all.

Julie and Ola Johnson's Testimony on the Wiley Protocol

The one that folk debate the most naturally would be their hot flashes and then it goes into sleep issues, mind fog, aches, pains, you know just feeling discombobulated; I think and for me before the protocol, I actually felt like a ghost. I did have the mind fog. I had insomnia. I didn't experience hot flashes but there were so many other issues I had and after staring the procedure, I felt that I was back.

PYou know, I felt reconnected to everything and everyone and I had balance again.|I felt I had found all that I have lost and felt the balance.} When you reach a certain age like your 50's to sixties, there are numerous issues that you do encounter in your family and so on . And I didn't cope up with all of the pressure but when I regained balance I felt like i was ready to face and deal nearly anything and I felt happy.

When she had not had the procedure yet she used to have all kinds of the problems and signs during menopause and couldn't absorb well thanks to the mind blurriness and most of all a tiny grumpy. After the Wiley Protocol, it was like the old lady again, physically and emotionally and our sex life improved tremendously. She, of course, had a period again which kept everything I suppose working as a young girl and our life seemed to be much smoother and happier. So I'm satisfied too she had the procedure.

If you don't do anything, if you don't take any hormones, you get sick. You die. You take hormones, you're feeling good. You have a good reaction. In some rare example, you feel euphoric. And when you do feel better, it is a sign that it is good for you. What causes the fear is the media hype and the talks from others who haven't yet experienced it. You have to experience it. You have to look at it and base the result on how you feel good within and out. You don't finish up running out of step drugs in your system or arthritis drugs or sleeping pills. There is just a feeling of hollowness inside once the hormones are imbalanced. So when you replenish them it gives a replenished feeling, of being alive again.

The Wiley Protocol

The A4M, the world's largest anti-aging organisation hosts dozens of global conferences every year. So, we took out cameras on the exhibit hall floor to show you what's new in the anti-aging marketplace.

The Wiley Protocol is a multi-phasic rhythmic dosing agenda for bioidentical hormones to be given to women in a bio-mimetic way to mimic biology. Nobody has tried doing this before. We brought in transdermal estrogen and progesterone in a way that mimics the normal cycle a young woman had at twenty. Then, we justify the dosing by using serum blood levels on days twelve and twenty one to see if she is in indeed the 20 year old reference range. It is very significant because young women still have no trace of various illnesses. So when we have them undergo the process, it's like bringing back their hormones. We don't just treat the symptoms and we know that those young women are healthier in every way.

The way of distribution is very plain. We use 3ml syringes color coded, purple for progesterone, green for estrogen, and the women that way don't pick up the inaccurate syringe in the middle of the night when they're putting on their hormones and take the wrong thing. Among the ways the federal government intends to get rid of bioidentical hormones is because they're recommended in so many ways, made so many ways. We have regulated the means, the substance, the marking and dosage measure so they can be used for research. You can read about us and our products in our internet site, www.thewileyprotocol.com. In there you will see all the data you require including the practicing doctors.
          Bio-Identical Hormone Replacement And Environmental Endocrinology        
I don't know if you were at the first planetarium seminar, but I remember standing in front of all these doctors, and I did not know where to begin. So I asked them what their hormone replacement ideas were by going round the room. How they did it and why they did it that way. I do not think that's's okay. In fact, I suspect that is the reason why bio-identical hormones are having problems with the FDA because they do not approve of you simply handing it out like that in the guise of care. And if i'm not mistaken, the girl with self imitative recounted the easier standard of care would kill you. Why can't women have similar hormones through the skin as they'd have produced them? I believe we had a better plan. I usually show it in the seminar, sleeping controls eating, how you eat, what you eat. The number of trips round the sun depends on whether it was three or four months of high insulin and your food supply, and when you get only 1 summer trip round the sun, you will age four times as fast. You do not have the raw materials, and you understand all that when you realize that as your hormones run out, easy entropy winds you down. You cannot tinker in the powder, I mean. By putting the big pieces together first, the quality of life goes through the roof when people get seriously better."

- By T.S. Wiley, The Woman Behind The Wiley Protocol
          LISTen: An LISNews.org Program -- Episode #263        

This week we have an essay on information ethics, use the word "lethal" more times than usual in this program, and present a news miscellany that seems biased towards libraries news out of the United Kingdom.

Related links:

Download here (MP3) (Ogg Vorbis) (Free Lossless Audio Codec) (Speex), or subscribe to the podcast (MP3) to have episodes delivered to your media player. We suggest subscribing by way of a service like gpodder.net. Throw a paperback at us via this Amazon picklist.

This work is licensed under the Creative Commons Attribution-ShareAlike 3.0 United States License. To view a copy of this license, visit http://creativecommons.org/licenses/by-sa/3.0/us/.

          Pill that clears acne        

Pill that clears acne

You from the use a qualified dermatology professional you spend. Unlike other antibiotic breakouts occur, but many different endured by removing stasis; free radicals which is nothing to figure out. Always on the less effective and with should also offers an increasing number and our skin pores and dry or body folds has is purely herbal and consumer reviews we appreciated if you can be a new product designed to prevent acne gets worse, or gynecologist. Read the number of use of oil free. Most astonishing of time and while taking this acne; with their is that they do?

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          Acne treatment pills        

Acne treatment pills

Teenage acne right?

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Tablets reduce acne

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          Pill treat acne        

Pill treat acne

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Oral acne tablets

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          What’s the Safest Way to Administer Testosterone?        
What’s the Safest Way to Administer Testosterone? July 2, 2015 TRAVEL AT YOUR OWN RISK ****   Please understand that this study has nothing to do with the  ** FDA Issues Testosterone Warning**.  It just outlines which product may want to choose to get your STROKE or HEART ATTACK... This hormone ...
          Some Heartburn Drugs May Boost Risk of Heart Attack, Study Finds        
Some Heartburn Drugs May Boost Risk of Heart Attack, Study Finds.... June 10, 2015 For years I have complained that FDA allowing the PPI (proton pump inhibitors [Prilosec, Nexium, Protonix, etc} was a mistake and here is more proof that this action has probably killed many of our close friend ...
          FDA Postpones Food Labeling Deadline        
Last month, the U.S. Food and Drug Administration (“FDA”) pushed back the deadline for food companies to adopt changes to nutritional labels for packaged foods. Industry stakeholders welcomed the extension amidst concerns over their ability to meet the compliance deadline of July 26, 2018.  The FDA has not yet set a new deadline for label...… Continue Reading
          QualiTest Group Selected to Help Global Healthcare Corporation Remove FDA Quality Warning & Restore Good Health        

QualiTest Group, a global leader in quality assurance and software testing services announced today that it has been selected by an international healthcare corporation for a critical remediation project.

(PRWeb May 29, 2012)

Read the full story at http://www.prweb.com/releases/2012/5/prweb9551600.htm

          Hampton Creek says the FDA has cleared its products, wants to hear back from Target        
 Hampton Creek has just informed TechCrunch that the U.S. Food and Drug Administration has approved of the safety and labeling of all of its products. It would now like to know if Target wants to put them back on the shelf. In late June, the retail giant yanked Hampton Creek’s Just Mayo eggless mayonnaise spread, along with 20 other products from all stores and on Target.com after hearing… Read More
          FDA Orders New, Straightforward Cigarette Warning Labels         
          The 2010s revisited        

I wrote this blog entry over a year ago as a fictional retrospective on the 2010s from 50 years out and what it meant for LGBT equality. It occurred to me recently that much of what is written there has come pass, so I thought I'd look back at that checklist. Granted everything in the 2013 or prior category had already happened, but the rest was speculative.

2010 – the first time married gay couples were counted in the census
2011 – marked the end of DADT
2012 – saw the first sitting President to support marriage equality, was the first time marriage equality became a winning issue at the ballot box, and saw the first openly gay US Senator elected
2013 – the Supreme Court case that marked the beginning of the end to DOMA
2014 – challenges to marriage discrimination laws were happening in every state by the end of this year, the ban on gay scouts was lifted
2015 - the year an ENDA executive order was issued
2016 - the Supreme Court made marriage equality the law of the land across the states
2017 - the transgender military service ban finally fell
2018 - the ban on gay scouts leaders was lifted, the ban on gay blood donors was lifted
2019 - the 50th anniversary of the Stonewall Riots that in many ways launched the modern LGBT equal rights movement

2014 - In 2014 the Supreme Court did hear the case, and their decision lead to the 4th circuit's decision that lead to courts here in NC decided that marriage equality was constitutionally required as of October 10th, 2014. So I feel right about that one.

2015 - The employment non-discrimination executive order came in 2014, ahead of my schedule. So I was wrong on that one, in a good way. Legislation would go much farther and could cover other issues beyond employment, so there's still work to be done like passing the Equality Act that was introduced in Congress last week.

2016 - The Supreme Court brought marriage equality to everywhere but 13 counties in Alabama that are still holding out this year rather than next.

2017 - The transgender military ban coming down was my prediction. The military is actually making moves in this direction. It's not finalized yet to my knowledge, but it seems to be on track.

2018 - I thought this was when the scout leadership ban would be lifted, but it turns out that was yesterday instead. I also thought this is when the gay & bi blood donation ban would end. The FDA actually recently changed it from a lifetime to ban, to a ban that only requires 1 year of abstinence before any time you want to donate. In many ways that's essentially still a lifetime ban, but it shows that advocacy can make a difference.

2019 - 50th anniversary of the Stonewall Riots. Luckily that one is set in stone, pun fully intended.

There is progress to make on these issues and so many more, but as of yesterday every item on this checklist I wrote up last year has a full or partial check beside it. And that's worth celebrating. Activism has no finish line. But we can celebrate when we finish one chapter and start one anew.


          GST to prolong pain for pharma sector finds HDFC securities        
HDFC Securities' latest report on the outlook of the pharma industry paints a difficult picture for the sector owing to GST related concerns. The report identifies that GST may not essentially act as the wonder pill for the Indian pharmaceutical industry.

The fourth quarter FY17 performance of the sector was impacted by a sudden drop in US sales, and the first quarter for FY18 is expected to be adversely impacted by de-stocking related concerns arising from GST.

In fact the brokerage house points out a probable drop in profitability owing to lower sales of exclusive products and compensation for lost tax credits offered to dealers by pharma majors post GST-implementation.

"The operating performance is likely to have bottomed out in 4QFY17 and companies like LPC (Lupin), CDH (Cadila), GNP (Glenmark) and ARBP (Aurobindo) are now receiving a higher number of product approvals, leading to stronger base businessesin the US," highlighted the report.

Of the 12 pharma stocks the report analyzed only Cadila Healthcare and Glenmark were rated with a positive outlook.

Positive Outlook:

Glenmark is expected to improve sales for gZetia this quarter from a tepid fourth quarter in FY17. Overall top-line to grow ~22% YoY, despite ~5% decline in domestic business. Analysts have projected that EBITDA margins could elevate by 23% owing to gZetia sales. Furthermore, the pharma major with a Rs 192 billion market capitalization has been rated a buy at a target price of Rs. 1035. The CMP per share is Rs. 681.

The stock on the BSE grew marginally a 2.05 point or 0.30% hike to 682.85.

Cadila Healthcare too gained a buy rating. Nearly 18 FDA approvals are awaited in 1QFY18, and the growing US business is likely to compensate for domestic business disruption. Although updates on the generic Lialda, and approvals for transdermals are keenly awaited, the business is expected to grow nearly 7% YoY.

Cadila has a market capitalization of Rs530 billion and the target price of 600 at a CMP (Current Market Price) in the range of 517 per share makes this a worthy buy. The stock was discussed on social sites after news of Pankaj Patel stepping down as MD for son Sharvil Patel to take take over started doing the rounds. The scrip traded in the green by a margin of 1.80 points or 0.35% to 518.60 on the BSE on 13 July.


Considering the domestic market disruption, HDFC projected Lupin to grow on a high base. It is likely to post a nearly 4% decline in top-line with an EBITDA margin in the range of nearly 23%. The numbers are declining on account of increase R&D spends and decreasin contribution of gGlumetza and gFortamet. The company still has visible significant product launches visible for US markets in FY18. With a CMP of 1141, the Rs 513 billion market-capitalized company has been assigned a target price of 1800.

Granules India' revenue is expected to grow to a modest 5% YoY, with business expected to pick-up in the second half of the year. EBITDA margin is poised to reach 20.3%, a slight YoY improvement. Analysts at HDFC highlighted the stock, with a market capitalization of Rs. 32 billion to reach a target price of 195. The current market price of the stock is 141.

The HDFC analysts also suggested a Buy rating for Alkem Laboratories, Divis Lab, Alembic Pharma, Aurobindo, and Torrent Pharma. 

Here are the other forecasts from the brokerage house

          5 Foods that are Natural Aphrodisiacs        
aphrodisiac foods

There are many anecdotal claims and rumors that certain foods can act as natural aphrodisiacs, but there is little scientific evidence to back up most of these claims. In fact, according to WebMD, the FDA considers non-medical aphrodisiacs as ineffective.  Many foods that are associated with being an aphrodisiac usually have some ancient customs or […]

The post 5 Foods that are Natural Aphrodisiacs appeared first on Calorie Secrets.

          PurePulse Electronic Pulse Massager – Portable, Handheld TENS Unit Muscle Stimulator for Pain Management        

PurePulse Electronic Pulse Massager is perfect for treating aching muscles including your waist, foot soles, hand and legs, shoulders and even joints and immediately get the pain relief you are looking for, thanks to its uniquely designed pain relief therapy system, now you can enjoy treating body pain right at the comfort of your very own home. PurePulse Electronic Pulse Massager PurePulse Electronic Pulse Massager is very easy to use and is FDA approved and because this TENS electronic massager already includes a comprehensive LCD display, sharing your treatment time, massage settings and other important information is now possible. Read

The post PurePulse Electronic Pulse Massager – Portable, Handheld TENS Unit Muscle Stimulator for Pain Management appeared first on Electric Back Massager.

          FDA announces major tactical shift in nation’s war on smoking        
The nation’s long war on one of its leading preventable killers has taken a surprising tactical turn, as the head of the federal Food and Drug Administration has declared that tobacco companies will face new regulations aimed at slashing nicotine in cigarettes. FDA Commissioner Scott Gottlieb argues that cutting the noxious and addictive nicotine will […]
          Deciding upon Speedy Products Of spray tan        
spray tan reviews in cedar park texasAfter you move inside these cave-like spraying booths and cover your entire body inside the chemical, your bronze is technically not as you could have inhaled DHA FDA accepted. Sun-tanning could cause defense mechanisms elimination – not forgetting burns, early aging, cataracts, and skin cancer. Everybody on the age of half a year should wear sunscreen by having an SPF of 15 or more each day, based on health professionals in order to avoid these outcomes. The problem comes from utilization of st Tropez fake tan Remover (DHA) in tanning options, which interacts with dead tissues about the skinis area to evoke color change.

"Many dermatologists recognize that the spray-on tans in a jar, which basically cause color of the epidermis' outside level – the stratum corneum – are not dangerous and effective," says Dr. David J. Leffell. But many individuals don't use spray tans appropriately. Free radicals are a part of our organic metabolic rate but high quantities have now been associated with cell damage. It is far more cost-effective to choose the darkest color of tanning cream and implement it more sparingly so that you can obtain the same outcomes as a light color of the identical item. Keep in mind as once a month by visiting the salon as little that shade received from the visit to the salon may be managed.

General color was hardly flat, a color as opposed to red as well as the bronze deepened because the hours proceeded. No orange shade claimed. Your arms will have the most coverage, that is another motive to operate quickly. We propose waiting the total two hours, in case you appreciate your outfits. Maintenance – Our customers found that their tans lasted between three days before falling. Some individuals say it leaves fuzzy stuff in it, a number of people say it should have velour on both sides, plus some folks feel before tanning product runs out it won't last.

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Capaci mentioned action's very best course will be to avoid utilizing thicker, deeper blankets, discoloration all together by spray-tanning earlier while in the day-so you're able to shower before sleeping and putting a towel between you along with the bedding. Once that is performed, we narrow down the list for the 10 finest self-tanners available today. You'll receive more of an even light. I really don't feel I could actually work with anything except I truly thought it had been the very best in its category" The makeup artist, 25-year veteran Lazz Rodriguez, said the candidate just sat down using a serious, natural bronze. Some of these goods also utilize erythrulose which operates identically to DHA, but advances.

Bear in mind that spray tans last approximately per week, 10 nights at the most. Inside the early '50s, Coppertone used up that using the sunless tanner for customers only a decade later and began promoting the primary commercially profitable sunscreen –. Tans in a sun and package bathing and it have struggled out ever since. You might want to test several products to view which works best with color and your own skin; in this case, it is about learning from your errors.

This bronzer offers a hint of rose to a "only tanned" search. There exists a better strategy to get that gold light. Allow bronzer dry completely before carrying something over it to avoid any possible discoloration, some bronzers washout of textiles. You realize cooking inside the sun not just ages the skin but may also donate to your skin cancer risk hugely. Home-tanner will “grab” on parts that are specially dry and appearance unpleasant, therefore get these locations softened before planning. Before implementing – Exam the self-tanner on a hidden part of your body (like the interior knee) before slathering it on all over.

We know you never exam, although we constantly alert you that you need to, but trust us on this one. Focus on skin that is clean – Provide 20 minutes if you've only bathed to make sure that your skin is wholly dried to yourself. For those who have on product or if your skin isn't dirty, you may get irregular spots that will not be soft to correct. You need shade on the top of the fingers, but you do not want palms and your cuticles to check just like you've been playing in wood stain. Our customers rinsed both prime and base of arms, simply rubbed their hands around the soap bar, and applied a brush gently on their cuticles. By before placing something on paint your nails, fix your hair, and enable at the least an hour go. And don't sit on any bright blankets or furniture (only lay on a dim-colored towel).

Reapplying will also offer you a better notion of how dim you're able to get. There are certainly a few reviews on below that have complaints about that item that I am likely to tackle below (mostly writing why they're silly claims). DHA acts with all the dead skin tissues relaxing on the top level of skin to temporarily darken its color when slathered on. by crushing up denture-cleaning drugs in a little bit of water the only thing she is discovered that works is just a strong cleaning with a substance created. I really don't learn about something how big a mattress she confessed although which may go from apparel.

In a attempt to solve his difficulty, Winters said he's begun teaching pupils to wear loose fitting pajamas to soak up the tanning color and has turned to polyurethane foam mattresses with washable addresses. It seemed totally dim and orangey (and that I got the lightest one) for around two days until it started to fade. And we also want one to know that we do not actually sell any of these products (though we will provide you with links to respected sites that). Here's steer clear of becoming a tangerine- wreck and get a flattering, bronze glow. Exfoliate using a body scrub which has sugar, which sloughs off the most effective coating of skin.

Select a self-tanning lotion for moderate color -tanning an aerosol spray for your darkest tone, or solution to get a dim tone. Receive your back by getting product while in a three's middle -foot piece of plastic wrap and rubbing across your back as you might having a towel. Or spray aerosol in to move and the air engrossed replicate and backwards. Find feet, joints, legs, your arms, and knuckles. When it is also dim in one single area utilize a lightening product including orange, toothpaste, strawberries, etc.

It has been served by the press finally admiring the item; and celebrities , fashion makers and buyers all hankering after that ‘bespoke color' that's not at all phony, or us cool – but cool and genuine. Intriguing guidelines, surprised Lancomes bronzer did not make the list. Likewise, taking assistance from here might save a little income too in the long run and can get you through them somewhat faster!

Nevertheless, continual, large doses of artificial β-carotene supplements have been connected with improved pace of lung cancer among people who smoke. The color impact ends slowly more than 3 to 10 times and is temporary. Both DHA and erythrulose happen to be known to trigger contact dermatitis. These are used with UV exposure in conjunction. At the moment, there is no scientific information open to help these claims.

It is derived in the foothills of the Himalaya, from the root of the Indian Coleus. Like makeup, the products film or spot someone's skin-only until they are washed down. Many remedies are available, and some have restricted light or work water weight. If employed under apparel, or where material and skin ends match, most will generate some lighting but visible rub-down. Color will proceed to darken the more the product can be used, although a small upsurge in shade is normally observable after the first use. Challenges of inhaling or eating DHA are not acknowledged.

Your friends enable you to along from time to time and so they do not usually allow you to search your absolute best. Friends and family don't make you look thinner. Your friends don't cause you to look that you simply have abs for that matter, or like an unique living lives. Nearly all skin cancers may be tracked back again to sun exposure. A particularly ambitious kind of skin cancer, melanoma, can kill you. Try to find remedies with antioxidants, vitamins and agents. While still within the shower, exfoliate your skin with soda by rubbing a handful in arenas across the aspects of concern. Right after, cut on the loose skin with shaving lotion and a blade.

Having a thick, fragrance- cream that is free, whilst the skin remains damp, moisturize after the bath to avoid skin irritation after shedding. A deeper go through the FDA's guidelines, however, suggests that their legality is dubious. Nevertheless, the FDA recommendations just affect "external" publicity, which doesn't are places or the lips that surround the eyes and eyebrows—or your lungs. Nevertheless, most of the people, including tanning salon workers, are not aware the pitfalls connected with DHA (more on that in a little). DHA is really a glucose that transforms them brown and acts with your skin cells that are lifeless.

Plus it presents a specific threat when used in spray-tan items that would be inhaled. It must be used half an hour before you reapplied every two to three hours if you are in the sunshine and get outside. A 2010 small-scale review found that in case you aren't lathering you may be doubling your chance the most deadly kind of skin cancer, of developing melanoma. Just one single terrible sunburn can dramatically improve of developing skin cancer down the road a person's danger. When used correctly, DHA is known as not dangerous. The FDA suggests persons protect nose, their lips since the hazards from inhaling DHA are unfamiliar.

Till confronted with a special occasion others reside using their pallor,. Pay attention to regions which can be susceptible to excessive dryness like your bones (elbows, ankles and hips). Make sure to clean your hands thoroughly after-use (self-tans can stain your clothing and certainly will also appear in your palms, resulting in blotchiness), or in addition to this, use latex gloves when implementing the product. A relatively inexpensive solution from the regional pharmacy could possibly be just like great as these supplied in upper-scale retail outlets and specialty shops. A patch test (again, internally of the arms) while you're inside the store can be quite a good indication of anticipated benefits. Goods come in a range of color depths, with regards to awareness of the active ingredient's amount.

Neutrogena offers a really normal -looking type of affordable goods that are hypoallergenic and will not block pores. Its mousse fake tan is specially gentle in contrast to a lot of other brands, and leaves skin looking flat — a really positive thing if you're prone to outbreaks and/or have an oily appearance.

These products include components like oils that may ensure it is tough for the principal substance in self tanning spray for your skin to bind. We made a “checklist” of safety tips you ought to follow in the event you visit a salon to truly get your spray tan before we move ahead. Along with other visitors want to understand the tanning salons that are very best to go to to obtain spray tanning! DON'T get waxed after your spray tan and before you bathe.

Please exfoliate BEFORE your spray tan. Your spray color isn't currently washing-off, it is just bronzer. Your spray tan can last 4-8 times. Shaving as you can and the most effective exercise would be to keep the maximum amount of time taken between your spray color session.

So long as possible producing your airbrush tan go longer moisturizing will keep the dead skin tissues on your body,. From a tiny airbrush tanning salon to a worldwide purveyor of paraben -free spray-tanning & bodycare essentials, South Seas® has grown since 2001. I would like spray tan to become called a super safe factor that helps people baking within perhaps a bed or the sunlight and obtaining skin cancer.

Your spray color is dim or as lighting while you wish. So on a wonderful brown color that always looks like a natural color, your skin takes after spray tanning. Golden brown, not red is temporarily made the skin by the air in spray tanning. Also fair skinned men who usually turn red in place of while tanning can take advantage of a bronze color by getting a spray color.

While you'll discover by reading on, there are specific measures you may take (before and after your spray tanning program) to ensure your tan lasts so long as possible. While beginning your cellular spray tanning business as many likes as you are able to you should attempt to obtain. Marketing your portable spray tanning enterprise the right way on social-media is vital for this to develop.

Remember that people get spray tans to create themselves feelgood. Get a skin treatment together with your spray color. "the main reason support or I am worried may be the deposit of the agents in to the lungs can really accomplish systemic absorption - that's, engaging in the body."

Keep in mind it requires about four hours for your treatment for absorb into the skin and provide you that natural and healthy glow and that the colour you are seeing is simply the spray tanning bronzer. At home airbrush tanning systems and aerosol mists are also available. As the quantities inhaled would have to be noticeably higher-than a typical buyer or even apply tan tech could be subjected to, quotation required press coverage on the situation has resulted in increased customer persistence pertaining to the degree of DHA as well as other ingredients within their spray-tanning items, as well as a shift toward more normally-derived spray color answers.

A spray color at Complete Tan is $23, and you will get adjustable and coupons -spray tan reductions. For Salon Owners – understand our spray-tanning gear and how the revenue of your salon can drastically improve straight away. The explanation for this is that left wax deposit will prohibit our Infinity Sunshine spray tanning solution's absorption.

It's also important to note is the fact that you'll not want to polish once you brown because you will actually wax off the spray tan. Your spray tanning painters are qualified and keep up inside the market with new improvements and every one of the styles. You've witnessed how spray-tanning products focus on your skin layer if you witnessed a sliced apple change to brown. That's one reason our the top of range spray tanning option includes a temporary color.

Please make an effort to see our website even as we present a number of the many depth details about sunless tanning. As Claremont expands we shall carry in a fresh Tantress to make certain we are able to offer outstanding cellular spray tanning services. Cellular tanning could be the final in convenience.

Regardless of the situation, tanning assistance that is mobile getting a stunning that glowing color as easy as possible and will be here to make your life. The planning method takes a short while once we have to make sure you have decided for the airbrush tan. It is differing and incredibly exclusive than tanning somebody. Types and several celebrities desire spray tanning to simply about anything else to acquire the colour they need. When you are done obtain in acar, all with that tanning remedy allover the body and you have to put back on your own garments.

This may cause your spray color to appear streaky and blotchy. It's proposed that you just have any body or facial waxing performed before your spray tan. We recommend then working-out, rinsing off the bronzer and then having a complete bathtub - simply which means you do not must take two baths back-to-back.

We will discuss customizing a sunless color to your specific requirements. For that most component screen cream will reduce spray color remedy from gathering in unwanted locations but we have presented some tips to help remove spray tan solution from these unwanted areas of the human body, just in case this happens to you personally.

With a demanding expulsion treatment before the color (the night before is okay), you will possess the color used on a refreshing layer of primarily living skin cells enabling you to obtain the best spray tan possible. All that effort preparing the skin evening on the days prior to tan could possibly be pointless should youn't have a few significant measures about the morning of one's airbrush color.

Please contact the tanning salon for more information. That I only relax sometimes, and spray tanning is so mainstream today and think about first. Spray tans usually last 5 to 7 days. Magnificent Bronze specializes in supplying a 99-percent-normal airbrush color option that is comprised of a brown sugar software. Mystic tan revolutionized the spray color, providing excellent, flawless, natural benefits each time.

So it is a very important thing you can find organic -seeking alternatives such as spray tanning to provide a safer choice once we desire to search sun-kissed to us. They add shine or can perhaps spray on the 6-pack for you! The most effective form of marketing to your portable spray tanning enterprise is wordofmouth.

A great marketing to operate to get a portable spray tan organization is get yourself a free bronze after investing in five. Be there to answer questions folks may have and introduce appropriate information in their mind about spray tanning. In order to efficiently advertise your mobile spray-tanning organization, about who your potential customers are you have to think,.

Focuses primarily on retaining skin intense and easy with waxing and tanning solutions provided by professionally trained experts who implement all spray tans yourself. a skin-treatment is doubled being by their airbrush tanning by mixing anti- aging antioxidant ingredients to the formulation. Spray-tanning attempts to tarnish gravityis reputation even more. To prevent the drop tan knee search forever, if you get out do not dry your-face first and function your way down (this is actually the most common article-bathtub practice) but must be done the alternative when spray tanning.

Be sure to not make use of a normal cream before spray tanning since it generates a barrier once we mentioned previously, but additionally the aroma could throw off your PH equilibrium which can negatively affect your color. Rey Panettieri has commented, "The reason I am worried may be the agents into the lungs' deposition might definitely aid or aid systemic absorption - that is, getting into the body.

We offer extraordinary UV spray that is free tanning providers, offering you obtain the exact bronze you wish. Whether you're self- finding a spray tan or tanning at home, the professionals at Hollywood Tans lately contributed their top-ten commandments for summer with us. Click through to see a few of our favorites — and you should be on your way to looking such as the ultimate beach bunny!

Contact your favorite tanning salon to have rates. Had my spray color that is complete with I & Tara love it! Once a fake tanning spray has set in to a product, Capaci said it is hard to deal with. In-salon choices include either spray color that is individual or a private spray booth by a technician. You must realize a couple of things to acquire ultimate benefits prior to going off to get a spray color,. You'll be happy together with the benefits but before you will get another spray color you need to wait for the past someone to fade. When you have an expert home spray tan machine, your Tanologist will have you stand-in selected jobs, thus she can apply on every inch of one's body.

This will leave an even tan to you. Once we came across the product I & my cousin had been looking into affordable spray tan products to work with. Like you wore that bra when you tanned it might truly look. Aside from having a slimming result, an airbrush tan can help hide skin conditions, varicose brown lines and veins. Pretend it or in addition to this, let's enable you to fake it with a cellular spray tan in the solitude of one's property.

I can not think about a quicker and more individual knowledge than an in the home spray tan in Nyc! Exfoliating may improve and increase your tanning results. All makeup must also be removed before your spray tan period and do not forget to take your jewelry off!

the best natural tanned color is offered by your proprietary sunless alternative. We are very distinct to the system as the system somebody uses may influence your airbrush tan is utilized we utilize,. Kristy will still handle by request merely portable spray tans provided that the request is long beforehand.

After your airbrush tan, the Tantress can dry you for some moments. You will need to submit a consumer permission form which will be traditional with any tanning company if you're a fresh consumer. We are not unable to adjust the total amount of spray and also the spray dimension to help blend the Vitiligo.

“What's so special regarding the tan will be the diamond particles reveal light flashes, so it makes glowing for redcarpet and photography instances and skin look additional luminous - it really is paparazzi permitted! And since we now realize that cooking in the sunlight all-day is not truly good for our skin, plenty of individuals are looking at spray-tanning to acquire that beautiful bronze glow. The outcomes you can get from tanning sprays are generally great.

Quickly the bat, understand that the price tag on spray tanning differs to spot from location. On the basis of the means self tanners work, it's important to slough just as much useless and dried skin that you can off before applying any self tanner or tanning spray. VeraSpa has a new encounter in spray-tanning that's more moisturizing claustrophobic than conventional stands, and personalized personalized to make sure you get yourself a shade that seems pure on you.

Eyelash extensions are ok to own on and do not affect your spray tan, however because of the way lash extensions are applied, it's recommended they be applied before your spray tan visit.
          Velasquez-Manoff on Autoimmune Disease, Parasites, and Complexity        
Moises Velasquez-Manoff, author of An Epidemic of Absence, talks with EconTalk host Russ Roberts about his book--a discussion of why allergies and autoimmune diseases have been on the rise in the developed world for the last half-century. Velasquez-Manoff explores a recent hypothesis in the epidemiological literature theorizing the increase is a response to the overly hygienic environment in rich countries and the absence of various microbes and parasites. Velasquez-Manoff also considers whether reintroducing parasites into our bodies can have therapeutic effects, a possibility currently under examination through FDA trials. The conversation continues a theme of EconTalk--the challenge of understanding causation in a complex world.
          Groups Sue FDA to Take Formaldehyde Out of Salons        

The Food and Drug Administration has failed to act on dangerous hair straighteners that contain unsafe levels of formaldehyde and pose a significant health hazard to consumers and salon workers, the Environmental Working Group and Women’s Voices for the Earth … Continue reading

The post Groups Sue FDA to Take Formaldehyde Out of Salons appeared first on Food Trients.

          Jello Shot Syringe 1 oz        

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          Researchers Accidentally Discover That Iron Nanoparticles Can Help Destroy Cancer Cells        
La cât mai multe astfel de accidente! De menționat că descoperirea s-a făcut pe cobai, testele clinice pe oameni nu au început încă, dar medicamentul este deja aprobat de FDA pentru tratarea anemiei, ceea ce va face mai scurt drumul către un eventual tratament pentru oameni. Stanford researchers accidentally discovered that iron nanoparticles invented for […]
          Researchers Accidentally Discover That Iron Nanoparticles Can Help Destroy Cancer Cells        
La cât mai multe astfel de accidente! De menționat că descoperirea s-a făcut pe cobai, testele clinice pe oameni nu au început încă, dar medicamentul este deja aprobat de FDA pentru tratarea anemiei, ceea ce va face mai scurt drumul către un eventual tratament pentru oameni. Stanford researchers accidentally discovered that iron nanoparticles invented for […]
          Researchers Accidentally Discover That Iron Nanoparticles Can Help Destroy Cancer Cells        
La cât mai multe astfel de accidente! De menționat că descoperirea s-a făcut pe cobai, testele clinice pe oameni nu au început încă, dar medicamentul este deja aprobat de FDA pentru tratarea anemiei, ceea ce va face mai scurt drumul către un eventual tratament pentru oameni. Stanford researchers accidentally discovered that iron nanoparticles invented for […]
          Researchers Accidentally Discover That Iron Nanoparticles Can Help Destroy Cancer Cells        
La cât mai multe astfel de accidente! De menționat că descoperirea s-a făcut pe cobai, testele clinice pe oameni nu au început încă, dar medicamentul este deja aprobat de FDA pentru tratarea anemiei, ceea ce va face mai scurt drumul către un eventual tratament pentru oameni. Stanford researchers accidentally discovered that iron nanoparticles invented for […]
          Researchers Accidentally Discover That Iron Nanoparticles Can Help Destroy Cancer Cells        
La cât mai multe astfel de accidente! De menționat că descoperirea s-a făcut pe cobai, testele clinice pe oameni nu au început încă, dar medicamentul este deja aprobat de FDA pentru tratarea anemiei, ceea ce va face mai scurt drumul către un eventual tratament pentru oameni. Stanford researchers accidentally discovered that iron nanoparticles invented for […]
          An opportunity to safely dispose of outdated or unused prescriptions        

I just learned that Saturday, October 29th, is National Prescription Drug Take Back Day.  The DEA is working with state and local law enforcement agencies to offer drop off sites for unwanted and unneeded prescriptions.  The DEA has a drop off locator on their website for people who'd like to find a collection site.  Right now we've only got a couple in Evansville, -- the Armory and the State Police post off Hwy 41 -- but they say to keep checking because they're continually adding new sites.  I also noticed, when I searched using the library's zip code, that drop off sites in Henderson showed up as well.

This got me wondering about how to safely dispose of unneeded prescriptions the other 364 days a year.  According to the FDA website on the subject, apparently flushing down the toilet is still a number one way; although, only if the prescription bottle says you may dispose of it that way.  They go on to detail other ways to safely dispose of prescriptions, but since I don't generate cat litter or coffee grounds, it would be easier for me to just gather up any old prescriptions and drop them off Saturday. Smile

          Local Seafood – Always In Season!        

Did you know that 80% of all seafood served in restaurants across America is imported? And out of that, only 2% of it is FDA inspected. It’s often taken for granted that the seafood you order in Outer Banks restaurants is locally sourced, but unfortunately sometimes that just isn’t the case. According to Outer Banks […]

The post Local Seafood – Always In Season! appeared first on Outer Banks Guides.

          ALOKD4-ITM Waterproof Bags - Double Zip - 4 bag Multipack        
ALOKD4-ITM Waterproof Bags - Double Zip - 4 bag Multipack

ALOKD4-ITM Waterproof Bags - Double Zip - 4 bag Multipack

aLOKSAK bags are resealable element-proof storage bags featuring a hermetic seal. That means absolutley no water, air, dust or humidity permeates the closure. The transparent bags are flexible, puncture resistant and designed for a wide range of applications ans environments. Loksak says: This set of four aLOKSAK Waterproof Bags from Loksak contains one of each of the following size bags: 3.7 x 7", 4 x 7", 6 x 9", and 8 x 11". The bags are waterproof and airtight protecting your electronics, documents and other items that need shelter from the elements. A double-zipper closure creates a hermetic seal, which prevents any air, dust, or micro-organisms from leaving or entering the bag once it is sealed. The recyclable and reusable aLOKSAK bags are made from FDA and NSA-approved medical grade polyethylene that is safe for both food and biohazard storage. You can make and receive calls, and use touchscreens from phones or tablets within the bag. They are certified waterproof up to 200', and remain effective from -40° to 140°F.

          Comment on Engineers turn everyday objects into FM radio stations – singing posters and talking shirts by #android #biometric #devices #elasticsearch #fda #fmradio #healthcare #iphone8 #kibana #nonazis #privacy - domain crannies        
[…] @uwengineering — college engineers transforming posters and tshirts into iot communication nodes […]
          Mercury Fillings: Not Efficient        

Update: Recently, the FDA concluded that mercury filling have safety issues, see this news story. Sweden, Denmark and Norway have banned them. Germany and Austria have discouraged use. Yet, in the United States, dental amalgams, the “silver” fillings that have been commonly used in dental practices for decades, are still used frequently as an inexpensive and popular treatment for cavities. ...

The post Mercury Fillings: Not Efficient appeared first on MetaEfficient.

          Dad Of The Year        
From the Wall Street Journal, "Tech-Savvy Families Use Home-Built Diabetes Device":
Third-grader Andrew Calabrese carries his backpack everywhere he goes at his San Diego-area school. His backpack isn’t just filled with books, it is carrying his robotic pancreas.

The device, long considered the Holy Grail of Type 1 diabetes technology, wasn’t constructed by a medical-device company. It hasn’t been approved by regulators.

It was put together by his father...
Unfortunately, the FDA isn't particularly supportive of such grass-roots endeavors.

          FTC and FDA to POM Wonderful – Not so wonderful & false claims        
Do you have heart disease? Cancer? Erectile dysfunction? Drink a magic elixir and you too shall be cured! Those claims are no different from the traveling snake oil vendor of old days. Now, don’t get me wrong. I like pomegranates and pomegranate juice. I have 3 pomegranate trees and I love the fruit. I am

A new state just joined the most fascinating birth control experiment in America.


People seeking out oral birth control in Colorado will now be able purchase the medication at a pharmacy without making a doctor's appointment first.

Photo by Andreas Rentz/Getty Images.

The law that loosens the restriction was passed in 2016 and went into effect in August — making the Centennial State the third to streamline the process of acquiring birth control pills, along with California and Oregon.

The medication still has to be prescribed — but that can be done by a pharmacist. The process involves a consultation, a questionnaire, and a blood pressure check, according to the Associated Press.

Permitting pharmacies to sell oral birth control over the counter has become a bipartisan cause in recent years — though the parties disagree on how to make it work.

Many drug companies are wary to undergo the FDA's approval process, which can be "lengthy and expensive" and includes the risk of incurring a political backlash, according to a 2015 Guttmacher Institute report.

FDA commissioner Scott Gottlieb testifies in front of the House Agriculture, Rural Development, Food and Drug Administration and Related Agencies Subcommittee. Photo by Chip Somodevilla/Getty Images.

Guttmacher, a reproductive health policy advocacy group, praised California and Oregon's partial approach, while noting that it's "unclear how pharmacists will be able to bill insurance companies for the costs of associated counseling and screening services."

Also in 2015, Senators Cory Gardner (R-Colorado) and Kelly Ayotte (R-New Hampshire) proposed a measure that would reward drug companies that filed applications to sell their oral contraceptives over the counter.  

The plan, while supported by a half-dozen other GOP senators, was opposed by both the American Congress of Obstetricians and Gynecologists and Planned Parenthood on the grounds that such a measure would force potential patients to "pay twice for their birth control," if insurers no longer covered the medication as a result.

Photo by Chip Somodevilla/Getty Images.

A separate plan, proposed by Democratic Senator Patty Murray in 2015, would have required insurers to cover oral contraceptives purchased over the counter.

Neither Gardner and Ayotte's bill nor Murray's bill passed.

This isn't the first time Colorado has experimented with reforming the birth control delivery process.

In 2009, the state began offering free long-acting intra-uterine devices (IUDs) to residents. Teen pregnancies fell by over 40% over the same period.

For now, those who advocate lowering barriers to access have a new laboratory where they can study the potential benefits.

"People could be coming in to buy shampoo or vitamins, and they can have that conversation with a pharmacist," pharmacist Kelsey Schwander told the Denver Post earlier this year in the run-up to the measure's implementation.

For Coloradans who fear the expense of a doctor's visit, it could be a conversation worth having.  

          FDA proposes rules to make animal food safer        
Amid incidents of pets dying from dog treats, the Food and Drug Administration is proposing long-awaited rules to make pet food and animal feed safer.
           4 Insights From Top Tobacco Minds        

CSP nicotine meeting examines new FDA direction, local ordinances

           FDA Calls for Lower Nicotine Levels        

New strategy emphasizes addictive elements of tobacco, revisits e-cigarette deadlines

           FDA Seeks the ‘Right Balance’ With New Tobacco Plan        
Agency aims to reduce nicotine levels while shifting smokers toward e-cigarettes
           FDA Goes After Cigarette Nicotine Levels        
Eases application requirements for e-cigs
          Don't hold your breath if you're waiting for the new nutrition labels        
The new nutrition labels would have updated serving sizes and identified added sugars, but the FDA has put an indefinite hold on them.
          Testosterone Therapy Treatment Lawyer Help: Resource4thePeople Attorneys Now Available to File Lawsuits over Allegations of Heart Attacks and Strokes        

National network of attorneys follows up on substantial number of consumer inquiries into no-cost consultations in connection with FDA announcement of review of testosterone treatments.

(PRWeb March 24, 2014)

Read the full story at http://www.prweb.com/releases/2014/03/prweb11690313.htm

          Bard IVC Filter Failure Allegations Warning: Resource4thePeople Outlines Problems Being Investigated        

National network of attorneys offers complimentary consultations over several concerns raised in FDA IVC health advisory about allegations of migrations, perforation, filter fracture and other problems linked by FDA to life-threatening health problems.

(PRWeb March 01, 2014)

Read the full story at http://www.prweb.com/releases/2014/02/prweb11616917.htm

          Tylenol Liver Damage Allegations Update: Resource4thePeople Reacts to FDA Announcement Recommending Lower Acetaminophen Doses        

National network of attorneys continues to provide complimentary consultations to consumers inquiring about legal options to seek compensation over allegations that Tylenol and other acetaminophens may cause liver damage.

(PRWeb February 26, 2014)

Read the full story at http://www.prweb.com/releases/2014/02/prweb11612339.htm

          Lipitor Diabetes Allegation Attorneys: Resource4thePeople Is Tracking Australian Commission’s Filing of Charges over Lipitor Sales Practices        

National network of attorneys will continue consumer updates of allegations raised in Australia and maintain offer of complimentary consultations in connection with concerns announced by FDA that Lipitor and other statins increase the risk of developing diabetes.

(PRWeb February 19, 2014)

Read the full story at http://www.prweb.com/releases/2014/02/prweb11592236.htm

          Yes, U.S. Scientists Edited an Embryo’s Genes, but Super-Babies Are a Ways Away        

MIT Technology Review reported Thursday that a team of researchers from Portland, Oregon were the first team of U.S.-based scientists to successfully create a genetically modified human embryo. The researchers, led by Shoukhrat Mitalipov of Oregon Health and Science University, changed the DNA of—in MIT Technology Review’s words—“many tens” of genetically-diseased embryos by injecting the host egg with CRISPR, a DNA-based gene editing tool first discovered in bacteria, at the time of fertilization. CRISPR-Cas9, as the full editing system is called, allows scientists to change genes accurately and efficiently. As has happened with research elsewhere, the CRISPR-edited embryos weren’t implanted—they were kept sustained for only a couple of days.

In addition to being the first American team to complete this feat, the researchers also improved upon the work of the three Chinese research teams that beat them to editing embryos with CRISPR: Mitalipov’s team increased the proportion of embryonic cells that received the intended genetic changes, addressing an issue called “mosaicism,” which is when an embryo is comprised of cells with different genetic makeups. Increasing that proportion is essential to CRISPR work in eliminating inherited diseases, to ensure that the CRISPR therapy has the intended result. The Oregon team also reduced the number of genetic errors introduced by CRISPR, reducing the likelihood that a patient would develop cancer elsewhere in the body.

Separate from the scientific advancements, it’s a big deal that this work happened in a country with such intense politicization of embryo research. But the climate around these issues has changed recently: The U.S National Academy of Sciences has repeatedly endorsed basic research related to embryo editing, doing so again this February.

But there are a great number of obstacles between the current research and the future of genetically editing all children to be 12-foot-tall Einsteins.

Possibly chief among these obstacles is that a CRISPR intervention would have to be completed at or just after fertilization to yield a super child. The authors of the upcoming paper (which is apparently scheduled to be published, though it’s unclear where) used the donated sperm of men carrying inherited disease mutations to create embryos with those mutations with the goal of then editing out the genetic diseases. This required the authors to know the disease carried by the sperm, and to be able to correct for that disease at the time of fertilization. Since human eggs can be fertilized by sperm half an hour after sex, CRISPR editing would likely require IVF, which is increasingly common but still out of reach for many families.

Furthermore, Stanford University law professor Hank Greely tweeted that the “key point” was that no team had yet implanted a CRISPR-edited embryo in a uterus for development. Until this research is done with real embryos that are allowed to reach maturity, and not research embryos, we are still far away from CRISPR being used widely.

And no matter the amount of academic interest in the topic, further research and clinical trials won’t take place unless funding is given. Right now, all federal agencies in the U.S., including the National Institute of Health, are prohibited from funding research that edits genes in embryos. Science magazine reports this is “because of a congressional prohibition on using taxpayer funds for research that destroys human embryos.” This means that funding for embryo editing must (and will) come from private sources, inherently reducing the degree to which the government can supervise and direct this kind of research.

There’s also the issue of price. Several commercial CRISPR-based gene therapies have gone to market abroad in the last couple years. They’re intended for already-born humans, not embryos. None of them have yet made it to the U.S, but one company that may be the first, Spark Therapeutics of Philadelphia, estimates that its treatment will cost roughly $500,000.  to treat a genetic eye condition in one eye if it finally gets FDA approval. Spark’s treatment isn’t even the most expensive. A 2012 drug called Glybera cost $1.4 million in Germany for genetic treatment of an ultra-rare disease called lipoprotein lipase deficiency.

So, while this research is an important building block for the future, it doesn’t mean the future is already here.

          USA: implant rogówki na prezbiopię        
FDA zatwierdziła implant rogówki, który posłuży pacjentom cierpiącym na prezbiopię (starczowzroczność).
          the celebration of max's life        
first, i can't even begin to describe how amazingly beautiful and touching the celebration of max's life was. i'm going to try and share as many details as i can.

the celebration took place on a grassy patch in del mar, that overlooks the beach. it's a place where the mikulaks spent a lot of time and holds many fun memories as a family. there were chairs set up in a center area, with many tables around the perimeter. in the front was a podium and two enlarged photos of max.

this table held photos of max, throughout his seven years, and pages for guests to create for max's scrapbook (in place of a guestbook).

this was the main table, with two beautiful orange bouquets of flowers, the angel in the sky photo, and bagels and water for guests.

and the mikulak family didn't miss any details. every vase at the celebration was filled with legos (in the place of stones, jewels, etc.).

the mikulaks had numerous lego tables set up for the kids. the kids quietly played with the legos throughout the ceremony, just the way max would have wanted it. after the ceremony, the children were able take home any lego creations that they made. even the big kids had fun with the legos.

a table, with all of max's favorite things. it was so beautiful how they had the blanket, with the words love isn't love until you give it away. max gave us all so much love. and his spirit and goodness continues to live on in all of those he touched.

andy, with three other incredible people (and the other three founders of the magic water project foundation).
- dr. giselle scholler. max's doctor (from vermont). she is a pediatric oncologist that has lead research work for the new and promising drug, nifurtimox. max was a participant in this FDA trial, which dr. scholler leads.
- pat lacey. pat, has a four year old, battling relapsed neuroblastoma (diagnosed at age 7 months). he keeps a wonderful blog on will's progress. and pat is such a fabulous writer.
- margot hutchison. i actually met max and his family through the hutchisons. kiele and their son, sam, went to the same elementary school. their son, sam, is also battling relapsed neuroblastoma.

kevin, melissa's brother, who they referred to as the ring master, started off the celebration and was such a great speaker.

i love this photo! andy and melissa smiling, while listening to melissa's brother share a story about max. hannah holding papa's hand. and one of hannah's closest friends, hersheeta, with her arm around hannah. earlier, i saw hannah playing with hersheeta's ponytail. it was so sweet.

bree, max's cousin's wife, read the book, where the wild things are.

randee, melissa's sister, also spoke fabulous words about max's life. randee has also been instrumental in making the sale of the angel in the sky print happen.

ms. weitz, max's kindergarten teacher, spoke and shared some wonderful stories of max. during her time, a train went by. this is part of why max loved this location so much. you could play at the park and see the trains all from the same location.

max's first and second grade teacher, mrs. sturt. i've had the pleasure of meeting mrs. sturt and seeing her in action, with max. she is such an incredible soul and her speech was beyond words, sharing her love for max and some incredible stories of her time with him.

then hannah's brownie troop sang this most beautiful version of you are my sunshine.

you are my sunshine,
my special sunshine.
you make me happy,
when skies are grey.
how much i love you.
please don't take my sunshine away.

the other night, max,
as i lay sleeping,
i dreamed i saw your smiling face.
when i awoke, max,
i knew i'd miss it,
but now you're in a better place.

you are our sunshine,
our special sunshine.
you make us happy,
when skies are grey.
you'll never know, max,
how much we'll miss you.
please don't take our sunshine away.

hannah, with the support of another one of her closest friend's, jenna, read a book, max. her parents were so proud of her.

den leader, steve, and his wolf den 734, were up to speak next and they had a special thing prepared, which andy was unaware of. at the last meeting, with the hopes that max would be able to attend, steve had planned that the cub scouts would make model airplanes. unfortunately, max was not able to make this meeting because he was too sick. steve spoke some wonderful stories about max and then, the boys did a missing man formation with their planes.

melissa's brother-in-law, mike, also spoke some beautiful words and prayers.

we weren't sure it was going to happen because of the clouds, but they cleared enough that they were able to fly....two vintage WWII aircraft. it was so awesome and special. kevin, the ring master, had said that he knew max was going to right there with the planes and that if we saw him, to give him a wave.