FDA Delays Avandia Ban in the Face of Major Cover-up

The FDA seems to be on a small spin out of control regarding the ban on Avandia. They have been acting uncharacteristically defensive and have unwisely fallen on the side of the drug company rather than the consumer. Now, consumers are dying because of their decisions.

You see, on Saturday the Senate Finance Committee came down with a decision in a report based on clear evidence recommending that Avandia, a popular type 2 diabetes medication produced and distributed by GlaxoSmithKline (GSK), be taken off of the market, because as they say in the report:

- Since 1999, Avandia has been linked to 83,000 heart attacks.
- GSK experts verified an outside study showing the cardiac problem, but the company publicly attacked the findings as incorrect.
- Two Food and Drug Administration (FDA) safety officials said the ongoing FDA study between rosiglitazone (the active ingredient in Avandia) and pioglitazone (a rival diabetes drug treatment) was unethical. They said rosiglitazone clearly causes heart attacks, but the study keeps going.

Today we learn from internal document uncovered by ABC News, the FDA calculates that if every diabetic now taking Avandia, were switched to a similar drug called Actos, it could prevent 6,000 heart attacks and 3,600 cases of heart failure, PER YEAR.

Yet the FDA has decided to delay a recall of Avandia until July 2010 to review the studies that have been released showing that Avandia. They say that they have to further review the senate’s 374 page document plus review recent studies conducted on rosiglitazone to get a cohesive causal evidence between rosiglitazone and myocardial infarction (heart attacks).

FDA Misses the Whole Point of a Cover-up

First, to justify the “cover-up” statement so to not sound conspiratorial, allow us to quote the Senate Report:

“It can be argued that GSK had a duty to warn patients and the FDA of the Company’s concerns. Instead, GSK executives attempted to intimidate independent physicians, focused on strategies to minimize or misrepresent findings that Avandia may increase cardiovascular risk, and sought ways to downplay findings that a competing drug might reduce cardiovascular risk.”

The FDA has had their hands on the New England Journal of Medicine 2007 study and the American Medical Association 2008 study for a long time now and these are the very studies that a lot of the Senate Finance Committee’s decisions are based on. He Senate report also reviews GSK practices and comes to the conclusion that they deliberately tried to cover up the results of specifically those two reports.

So what is the FDA’s problem? Doctors have alternative drugs to prescribe that treat their patients. The FDA should recall the drug merely based on the blatant cover-up.

The Hard Numbers

Using simple math, if 83,000 patients have had heart attacks related to Avandia in 11 years, that’s 4015 heart attacks per year. That comes to 21 heart attacks per day. Heart attack statistics show that on average 37% of heart attacks are fatal. That means 7 – 8 people die per day from Avandia heart attacks.

By the FDA holding the decision for another 100 days, that’s another 700-800 deaths that the FDA could be stopping.

According to reports, GSK makes $3 billion from Avandia alone per year, $2 billion of that in straight profit. Is that worth 8 innocent lives? Obviously there are some drug company executives that think so.

What this leaves me wondering is, what portion of the $550,000,000 dollars that GSK is going to make in the next 100 days is going to tip-toe its way to the FDA officials and those supporting “further research”?

Do We Now Have to Protect Ourselves from the FDA?

The FDA does a lot of good for the American people and the public over all. The problem is that when it does bad people get sick, get sicker, or die. Those three residual effects of “badness” are the very three things they solely exist to prevent.

Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, is the person who is blocking the Avandia recall. It is now important that she justifies her decision based on the numbers stated above.

She has yet to do that.

If you or a loved one is affected by Avandia or related type 2 diabetes treatments, it is also recommended that you obtain legal representation. Call Phillips Webster for a consultation and to review your legal options.