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Avandia: The Damning Report Behind the Headlines

The following is the un-edited Conclusion from the Executive Summary of the 342-page report issued by the COMMITTEE ON FINANCE, UNITED STATES SENATE:

“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.”

You can READ THE 342-PAGE SENATE REPORT RIGHT HERE

It details the great lengths the most senior management within GSK went to cover up the fact that their drug was killing people and clearly demonstrates their complete lack of concern for the health and well being of the company’s customers. The case also brings to light severe conflict of interest issues within the FDA.

Max Baucus, a Montana Democrat, and Chuck Grassley, an Iowa Republican chaired the committee that created the report.

Grassley said the internal agency battle shows the FDA needs to be reorganized to give more power to safety officials over their counterparts who approve drugs and deal more directly with industry. “It doesn’t make any sense to have these experts who study drugs after they have been on the market for several years under the thumb of the officials who approved the drug in the first place and have a natural interest in defending that decision,” Grassley said. “The Avandia case may be the most alarming example of the problem with this setup.”