Profits over patients health?

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The FDA called an advisory board to review the safety of Avandia and when it was all over patients lost and big business won. By saying there isn't enough data they essentially are telling patients "you decide if you want to take the risk". Even a leading physician, interviewed on NBC Nightly News, didn't know what to recommend to his diabetic patients. So new warnings will be included on the label of Avandia and the drug industry has lost another chance to gain consumer trust. Read More...
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It's over for Avandia

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Think that the Internet has not played a role in the decline in sales of Avandia? Think again. I had the chance to talk to three physicians last week about Avandia and they have switched all their diabetes patients from Avandia to other medications. As one physician told me "why take a chance with my patients health?".
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Opening statements

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Well it take long for me to get some eMail on my last post. Thank you for responding and raising some great issues, but for a moment put yourself in a patients shoes. You are a Type 2 diabetic doing well on Avandia and really don't want to switch to another medication. As a patient what I would want to know is; what are the risks of a heart attack on Avandia, and what are my risks for a heart attack on Avandia? I would want to know the percentage of patients in ongoing clinical trials that had issues and if these issues were due to the medication or other risk factors including weight, family history of heart disease and high cholesterol. So the questions remain for GSK and the FDA to answer. Read More...
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The vultures pounce

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What do sperm and lawyers have in common? One in ten million has a chance of becoming a human being. The legal profession overlooks no opportunity to chase an ambulance and make a few dollars. The latest? A class actions suit by investors against GSK alleging the drug company misled investors about the safety of diabetes drug Avandia, a step investors have taken in past drug-safety disputes. This of course while there is still dispute over the what the data actually says but no matter lawyers are already recruiting patients from TV ads for class action against GSK. Read More...
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Credibility? We don't need no credibility !

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A while back we conducted two days of research with people who have diabetes. The subject of credibility seemed to come up again and again when discussing their informational needs to help them decide on treatment options. It comes down to this: people want clear and concise information on the product, its side effects and want promotional information to be separated from medical information. (DUH!) Well as the battle over Avandia, and now Actos, intensifies some publications are theorizing that GSK may have manipulated data to meet marketing objectives. From an editorial in today's New York Times:

One disturbing possibility is that Glaxo has designed tests that have the effect of meeting the company’s marketing objectives while minimizing risks. The F.D.A. may have allowed itself to be outmaneuvered, approving designs that won’t fully answer key safety questions.

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Politicizing science

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What a mess ! That's the only way to think of the black box warnings that were added to Avandia and Actos. The hearings yesterday resembled a circus with finger pointing and clear lines of difference between Democrats and Republicans on the data that was first reported in the NEJM. What are physicians and patients supposed to think? Is the data telling us the glass is half full or half empty? Rather than utilizing the opinions of third parties, namely physicians who have no vested interest in the product, politicians took it among themselves to interpret data mispronouncing words along the way. This is what happens when politics is mixed with science and this is going to have broad implications for patients and the pharmaceutical industry for years to come. Read More...
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The beat goes on

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Well the finger pointing continues with the Avandia data with continued media coverage most recently on the front page of today's New York Times. While some doctors are taking a 'wait and see" attitude it seems that GSK has already started to feel the effects of this story with declining sales. Meanwhile what are patients expected to think? Accusations and counter accusations are flying back and forth which has done little to make patients comfortable with treatment for Type II diabetes. Read More...
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NEJM playing politics?

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Every so often someone becomes the voice of reason in a crazy world. The latest example was Dr gottlieb's letter in Tuesday's Wall Steet Journal that questions the journals release of an article questioning the data on Avandia. As he writes "Unfortunately, major medical journals that should be filling this role often put more weight on pushing political agendas. Their editorial prejudice has left a troubling void for rigorous and unbiased arbiters of medical evidence who can guide sound medical practice decisions. Wow ! But wait there is a lot more here.. Read More...
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