A 33 member voting panel of Food and Drug Administration (FDA) will decide the fate of Diabetes drug AVANDIA. Avandia has been under criticism for quite some time now, and back in 2007 another FDA panel voted on the drug, and voted 22-1, to leave it on the market. The current panel spent two days in analyzing all the evidence in favor and against Avandia. Today the panel will receive a presentation from the scientists of GlaxoSmithKlein, the marker of Avandia, followed by a presentation of Dr. Steven Nissen, medical director of the Cleveland Clinic and a sharp critic of Avandia.

The Senate Finance Committee Avandia reports a damning profile of both GlaxoSmithKline and the FDA. Had either put the interests of patients first, thousands of Avandia-related heart attacks may have been prevented. Filing an Avandia heart attack lawsuit is one way victims of this drug can make sure GlaxoSmithKline is held accountable for the way it handled Avandia's heart risks.

If you or someone you love suffered a heart attack, stroke or congestive heart failure while taking Avandia, you have legal rights. Please fill out our online form or call 1.866.789.1664 as soon as possible to discuss your case with one of our product liability lawyers.

In February 2010, A Senate Finance Committee report found that GlaxoSmithKline, the maker of Avandia, not only knew about this drug's heart attack risks since 1999, but worked to keep vital safety information from the public. M&A Law Firm is determined to make sure the drug company is held accountable for its failure to warn patients about Avandia's serious health risks—heart attack, stroke and congestive heart failure.

The Senate Finance Committee Avandia report released in February 2010 was the result of a 2-year investigation and draws from more than 250,000 pages of documents provided by GlaxoSmithKline, the FDA and several research institutes, as well as interviews with officials from both the company and agency, and anonymous whistleblowers. According to the Senate report, the FDA's own reviewers recommended that Avandia be removed from the market as early as 2007.

The report maintains that 500 heart attacks and 300 cases of heart failure could be avoided each month if diabetics taking Avandia were treated with an alternative medication. In July 2007 the FDA’s own scientists estimated that Avandia was responsible for an estimated 83,000 heart attacks, the Senate report says. The report maintains that some of those could have been avoided if Glaxo had considered Avandia’s cardiovascular risks in 1999 when they were first raised. Instead, the report maintains that Glaxo tried to undermine criticism of the drug.

“GSK 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,” the report says.

The Senate committee report doesn’t address whether Avandia should be taken off the market, but documents included with it indicate that some FDA reviewers clearly thought that should happen. For instance, an October 2008 internal FDA memo authored by Dr. David Graham and Dr. Kate Gelperin recommended then that Avandia be removed from the market because of heart risks, but nothing was done. Dr. Graham had actually argued to an advisory panel in 2007 that Avandia sales should be stopped. Unfortunately, that panel voted 22-1 to recommend Avandia remain on the market.

According to the Senate report, FDA reviewers also questioned an Avandia study called TIDE being conducted by GlaxoSmithKline. TIDE, which will compare Avandia with another diabetes treatment, Actos, was ordered by the FDA in 2007, when it mandated the black box heart attack warning. Reviewers called the study “unethical and exploitative” because patients given Avandia face far greater risks than those given Actos, with no promise of any additional benefit. Despite these concerns, TIDE was still enrolling patients as of February 2010.

At the same time they released the Senate report, Sens. Max Baucus (D., Mont.), chairman of the Finance Committee and Chuck Grassley (R., Iowa), the panel’s leading Republican, wrote to the FDA asking it to take more stringent actions to protect the public from Avandia health risks, and expressing concern that the TIDE trial was allowed to proceed.

“Americans have a right to know the 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,” Sen. Baucus said in a statement announcing the Senate Finance Committee's Avandia findings. “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.”