Barely has the dust settled on the Celebrex research fabrication fiasco before another Big Pharma scandal has erupted. This time it centres on the diabetes drug Avandia, manufactured by GlaxoSmithKline.
US Senators have published a damning report linking Avandia (rosiglitazone) to heart attacks and deaths while two drug safety reviewers have recommended that it be pulled from the market. “At a July 30, 2007, safety panel on Avandia, Food and Drug Administration (FDA) scientists presented an analysis estimating that Avandia use was associated with approximately 83,000 excess heart attacks since the drug came on the market.”
Even more shocking (actually not so shocking-lah), the Senate Finance Committee report suggested that GSK was aware of the cardiac risks associated with Avandia years before the evidence became public.
Check out the conclusion of the report. The findings amount to a severe indictment of Big Pharma firms, which in recent years have had to pay staggering amounts in criminal fines:
In preparing this report, Committee investigators reviewed over 250,000 pages of documents provided by GSK, the FDA, the University of North Carolina, and others. Anonymous whistleblowers who contacted Senator Grassley’s investigators provided hundreds of other pages. For well over a year, Committee investigators also conducted numerous interviews and phone calls with GSK, the FDA and anonymous whistleblowers.
The totality of evidence suggests that GSK was aware of the possible cardiac risks associated with Avandia years before such evidence became public. Several years prior to Nissen’s study, it can be argued that GSK was on notice that Avandia may have problems. 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.
In recent years, pharmaceutical companies have committed acts that forced them to pay the largest criminal fines in American history. In cases involving Pfizer, Eli Lilly, Bristol Myers Squibb and four other drug companies, these fines and penalties have totaled over $7 billion since May 2004.
In particular, Pfizer has been fined multiple times in the past 6 years for illegal off-label promotion of their drugs. In its latest plea agreement, which took place last September, Pfizer paid $2.3 billion in fines and penalties for off-label promotion of Bextra. This settlement was the largest criminal fine in U.S. history.
Such an environment requires diligent oversight by the FDA to protect the citizens of this country and to ensure the safety of American medicine.
Ho hum, just business as usual. Pity the poor patients.