"This new allegation is especially significant and raises our level of concern about FDA interference in safety decisions regarding Avandia," Congressional investigators said in a letter sent to the FDA.
Since 2005, the scientist, a medical officer who was once Avandia’s primary reviewer, believed that Avandia’s risks warranted a strong “black box” warning for its risk of congestive heart failure.
In May 2007, a study in the New England Journal of Medicine found that those taking Avandia had a 43 percent higher chance of having a heart attack.
The scientist was "sidelined after voicing safety concerns," the Congressional letter said, and “was told to stop participation in the review of potential cardiovascular safety problems associated with Avandia.”
The FDA said it did ask for a black box warning for Avandia’s heart risks in June, and an outside advisory panel is meeting to discuss the risks further. The Agency has received the letter, according to FDA spokeswoman Julie Zawisza, and is planning to respond.
Avandia, made by GlaxoSmithKline Plc, brought in more than $3 billion in sales in 2006.
The primary reason why this is so tragic is that the drug being manipulated and promoted as a solution for type 2 diabetes is absolutely unnecessary in virtually ALL cases that it is prescribed for. This disease is virtually 100 percent reversible with the appropriate diet and exercise program, as I explained in my video from earlier this year.
Yet the drug companies continue to promote highly profitable drugs for a disease that, in absolutely no way, requires a drug solution. Avandia is starting to resemble the Vioxx (Merck’s painkiller that doubles your risk of a heart attack) catastrophe, as a month after the New England Journal of Medicine revealed that Avandia causes a 43 percent higher risk of heart attack, reports of side effects to federal regulators tripled.
This drug has been on the market for eight years, and studies by the drug’s own maker indicated heart risks before they were exposed by the New England Journal of Medicine study.
At least one FDA scientist also suspected risks well before the study came out, and, not surprisingly, the Agency had him or her removed from their post. The FDA is becoming notorious for protecting the hand that feeds it, at just about any cost -- even the cost of lives lost from taking deadly drugs.
Take the case of Vioxx. After being recalled from the market and causing 55,000 deaths, it was re-approved by, none other than, the FDA. How? Ten of the 32 panel members who voted in favor of Vioxx had blatant ties to the industry.
There is a reason why 80 percent of the FDA’s resources go toward approving new drugs. It’s a classic example of the fox guarding the henhouse.
The FDA will weed out those who are willing to challenge their loyal “customers,” the drug companies. It happened to this FDA medical officer over Avandia; it happened to one of my heroes, Dr. David Graham, over Vioxx, and it’s surely happened to many, many more.
If you would like to voice your opinion about this latest FDA scandal, we were able to uncover contact information for Julie Zawisza, the FDA spokeswoman mentioned in the above article. You can reach her at:
- Phone: (301) 827 5674
- E-mail: firstname.lastname@example.org
Please spread the word: Type 2 diabetes is not only preventable, it’s curable, if you make some simple lifestyle adjustments.