Senate Report Questions Avandia

Baucus, Grassley Release Finance Committee Report on Diabetes Drug Avandia, Express Concern About FDA’s Role in Protecting Patients in Ongoing Avandia Study

WASHINGTON – Senator Max Baucus, Chairman of the Committee on Finance, and Senator Chuck Grassley, Ranking Member, today released a committee report based on a twoyear inquiry of the diabetes drug Avandia. The senators also asked the Food and Drug Administration to describe what steps the agency has taken to protect patients in an ongoing Avandia clinical trial, and why the study is allowed to continue, given that the FDA itself estimated that the drug caused approximately 83,000 excess heart attacks between 1999 and 2007. In 2008, FDA officials called the clinical trial, as then-designed, “unethical and exploitative” of patients.

“There’s a real problem when FDA’s office that reviews drugs that are on the market is an unequal player in drug safety efforts,” Grassley said. “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. The Avandia case may be the most alarming example of the problem with this set-up.  Both the FDA and Congress need to take every step possible to establish independence for post-market surveillance. The Institute of Medicine has made recommendations. It’s a matter of sound science and public safety.”

“Americans have a right to know there are serious health risks associated with Avandia and GlaxoSmithKline had a responsibility to tell them. Patients trust drug companies with their health and their lives and GlaxoSmithKline abused that trust,” Baucus said. “We will continue watching closely and working with the FDA to make sure patients and doctors are aware of the risks associated with Avandia and all drugs so they can make safe and informed decisions when
choosing their medicines.”

The committee report explores when the Avandia manufacturer, GlaxoSmithKline, became aware of heart attack risks associated with the drug, whether the company sufficiently warned patients and the FDA of the dangers, and steps the company apparently took to create doubt regarding negative findings about the drug.

The report was developed over the last two years by committee investigators who reviewed more than 250,000 pages of documents provided by GlaxoSmithKline, the FDA, and several research institutes. Committee investigators also conducted numerous interviews and phone calls with GlaxoSmithKline, the FDA and anonymous whistleblowers. The report can be found at finance.senate.gov.

Baucus and Grassley directed the report over concerns that Avandia and other highprofile drugs such as Vioxx put public safety at risk because the FDA has been too cozy with drug makers and has been regularly outmaneuvered by companies that have a financial interest in downplaying or under-exploring potential safety risks. In 2007, Congress enacted legislation giving the FDA some new tools to better protect patients from harm caused by drugs that are brought to market without sufficient safety oversight or consumer warnings. However, the legislation did not fix a fundamental problem at the FDA — the imbalance between the office responsible for monitoring the safety of drugs after approval and the office that puts drugs on the market in the first place.

The FDA has overlooked or overridden safety concerns cited by its own officials, as appears to be the case with the ongoing Avandia study.

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