You can’t pick up a paper or turn on the news this week without hearing about Avandia, the latest blockbuster drug in the spotlight for potentially deadly side effects. This treatment, prescribed to about 6 million diabetics since 1999, is likely to increase cardiovascular disease and heart attacks in its users.
And who do we have to thank for bringing this serious issue to the public’s attention? The FDA? Try again. GlaxoSmithKline, the maker of the drug? Yeah, right.
A cardiologist at the Cleveland Clinic took advantage of Glaxo’s online posting of Avandia’s clinical trials and did his own analysis, and the New England Journal of Medicine published his findings. And they don’t look good for Avandia.
And what’s worse (although frankly not shocking) is that the FDA was warned about these risks years ago:
“The letter in 2000 to the F.D.A. was written by Dr. John B. Buse, chief of endocrinology at the University of North Carolina in Chapel Hill, who is about to become the president of the American Diabetes Association. His letter from seven years ago sounded an alarm about Avandia, citing ‘a worrisome trend in cardiovascular deaths and severe adverse events’ among patients using the drug.”
The few feeble attempts that the FDA made to get Glaxo to change the warning label on the bottle were largely ignored, and concerns expressed by some FDA drug safety officials were squashed (seems like Vioxx deja vu all over again…this will surely heighten calls for an independent office of drug safety).
And drug companies are not required to post their clinical trials… Avandia’s were only available because of a clause in a settlement Glaxo made when they were sued by New York State over Paxil. So if the drug companies are going to knowingly put unsafe drugs on the market, and the FDA knowingly does nothing about it – is it any wonder that doctors are doing their own research and speaking out so they aren’t UNknowingly prescribing deadly drugs to their patients? If this doesn’t underscore the need for public disclosure of ALL clinical trials, what does?