A bipartisan multiyear Senate investigation — whose results are expected to be released publicly on Monday, and was obtained by The New York Times today— sharply criticizes GlaxoSmithKline, saying it failed to warn patients years earlier that Avandia® was potentially deadly.
“…, G.S.K. 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,” concludes the report, which was overseen by Senator Max Baucus, a Montana Democrat, and Senator Charles E. Grassley, an Iowa Republican.
Mr. Baucus said of the report, “Patients trust drug companies with their health and their lives, and GlaxoSmithKline abused that trust.”
Avandia® was once one of the biggest-selling drugs in the world. Driven in part by a multimillion-dollar advertising campaign, sales were $3.2 billion in 2006.
The drug, known as ROSIGLITAZONE (roe si GLI ta zone), is an oral tablet that helps to treat type 2 diabetes by helping to control blood sugar. Treatment is typically combined with diet and exercise.
GlaxoSmithKline does note this warning on their website:
AVANDIA can cause or worsen heart failure. If you have severe heart failure (very poor pumping ability of the heart) you cannot be started on AVANDIA. AVANDIA is also not recommended if you have heart failure with symptoms (such as shortness of breath or swelling) even if these symptoms are not severe.
AVANDIA may increase your risk of other heart problems that occur when there is reduced blood flow to the heart, such as chest pain (angina) or heart attack (myocardial infarction). This risk appeared higher in patients taking medicines called nitrates or insulin.
But a 2007 study by a Cleveland Clinic cardiologist suggesting that the drug harmed the heart prompted the F.D.A. to issue a warning, and sales plunged. A committee of independent experts found in 2007 that Avandia® might increase the risk of heart attack but recommended that it remain on the market, and an F.D.A. oversight board voted 8 to 7 to accept that advice.
“Rosiglitazone should be removed from the market,” one report, by Dr. David Graham and Dr. Kate Gelperin of the Food and Drug Administration, concludes. Both authors recommended that Avandia® be withdrawn.
GlaxoSmithKline has rejected (PDF) the conclusions of the Senate Committee on Finance Staff Report, claiming contrary supporting evidence of the drugs safety.