The U.S. Senate Committee on Finance sent a blistering letter on Feb. 18 to the FDA questioning the agency’s actions regarding the diabetes drug rosiglitazone (Avandia, GlaxoSmithKline).
For the past two years, the Committee on Finance, led by Senators Max Baucus, D-Mont., and Charles Grassley, R-Iowa, have been pouring over hundreds of thousands of documents while investigating what GlaxoSmithKline (GSK) knew about cardiovascular risks associated with its drug and what the company possibly did to hide those risks. The committee's report can be read here.
In the letter, the two ranking members of the committee said that the evidence suggests GSK was aware of such risks and that based on this knowledge, “GSK had a duty to sufficiently warn patients and the FDA of its concerns in a timely manner.
“Instead, GSK executives intimidated independent physicians, focused on strategies to minimize findings that Avandia may increase cardiovascular risk, and sought ways to downplay findings that the rival drug Actos (pioglitazone) might reduce cardiovascular risk,” they wrote.
But Baucus and Grassley want to know why the FDA failed to heed warnings from its own safety officials regarding the drug.
In the letter, the two senators cited evidence that FDA officials raised concerns about an increased risk of heart attacks and heart failure with rosiglitazone compared to pioglitazone and concluded that “any proposed head-to-head trial would be unethical and exploitative.”
Those same FDA officials said that the “safety of the TIDE study itself cannot be assured, and is not acceptable.”
In 2007, the FDA had asked GSK to perform a cardiovascular safety trial, called TIDE (Thiazolidinedione Intervention With Vitamin D Evaluation), to compare rosiglitazone to other diabetes treatments such as pioglitazone.
Baucus and Grassley noted that the TIDE study is still recruiting patients and want to know what “steps the FDA has taken to protect patients in the TIDE trial, and why this trial is allowed to continue.” They also expressed alarm that the warnings from the FDA safety officials “do not appear to be addressed in the consent form.”
The senators requested an answer from the FDA by March 4.
In related news, the FDA on Feb. 22 issued a statement saying that it is reviewing data from the long-term clinical study RECORD on possible cardiovascular risks with rosiglitazone. The agency said its review of all data regarding rosiglitazone is ongoing.
Related articles from our archives:
BMJ: Actos leads to less heart failure, death compared with Avandia
Lancet: Avandia does not increase overall cardiovascular death in diabetes
ADA: Avandia does not increase CV disease, death, but increases heart failure
Troubled Avandia does not prevent plaque buildup either
Heart editors: Class of diabetes drugs carries significant heart failure risks
GlaxoSmithKline, McKesson sued over Avandia ‘wrongful deaths’