FDA- Pull Avandia
The news is not good for the GlaxoSmithKline drug, Avandia.
Confidential Food and Drug Administration (FDA) studies recommend the diabetes medicine be pulled from the market because of its link to heart risks.
The studies surfaced from staff members with the Senate Finance Committee which is investigating what Glaxo knew and when it knew it.
Avandia is also known by its generic name, rosiglitazone or rosiglitazone maleate.
Sens. Charles Grassley (R-Iowa), and Max Baucus (D-Montana), note that Glaxo was aware of the possible heart attack link as far back as 2007 when Dr. Steve Nissen of the Cleveland Clinic published a study that found a 43% higher risk of cardiovascular events among patients taking Avandia.
After that, Glaxo added a black box warning to the drug.
As recently as the third quarter of 2009, the FDA’s David Graham and Kate Gelperin concluded Avandia should be taken off the market because of the increased risk of heart attacks. An FDA panel voted in 2007 that Avandia did increase the risk of heart attack, but agreed to leave it on the market.
The Senate committee concludes that Glaxo was aware of the dangers of Avandia even before 2007, but intimidated doctors and scientists who raised concerns.
Glaxo says its own studies do not find a link to heart attacks and it did not try to intimidate anyone, reports the Wall Street Journal.
Clinical Trial Unethical
With the debate brewing for years, the Senate investigation and a new clinical trial have brought the issue to a head.
The Senate Finance Committee report says that Glaxo had a duty to warn patients and the FDA. Sens. Grassley and Baucus also conclude that any head-to-head trial comparing Avandia to Actos (Takeda Pharmaceutical) would be “unethical and exploitative,” however, Glaxo is currently sponsoring the TIDE study where patients are put on either Avandia or Actos, or other medications.
The New York Times writes that if Actos were given instead of Avandia, about 500 heart attacks and 300 cases of heart failure would be avoided every month.
Avandia was once one of the biggest-selling drugs in the world with sales of $3.2 billion in 2006, partially driven by a multimillion-dollar advertising campaign writes the Times.
As far back as October 2008, Public Citizen petitioned the FDA for an immediate ban of the drug Avandia because it can cause death from liver failure and many other life-threatening risks that far outweigh its benefits.
While reviewing U.S. Food and Drug Administration data, the consumer group found 14 unpublished cases of severe drug-induced liver failure, including 12 deaths. #