FDA drug safety experts Dr. David Graham and Dr. Kate Galperin sharply criticized the agency for including consultants who were biased against an Avandia recall on a 2010 FDA drug advisory panel. This most recent criticism of FDA Avandia review was published in the British Medical Journal (BMJ) on September 7, 2010.
The 2010 joint committee voted 20 to 12 against recommending an Avandia recall to the FDA. Avandia panelists included members of the Endocrinologic and Metabolic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee. In addition, members of a 2007 FDA advisory committee that voted 20-3 against an Avandia recall also were included on the panel, “even though they were no longer active members of either committee.”
Of the 32 panelists who voted at the 2010 meeting, 16 also had voted at the 2007 meeting. All but one of the 16 panelists who attended both meetings voted against an Avandia recall in 2010. Dr. Graham and Dr. Gaperin write:
“The addition of these former members substantially biased the results of the vote on whether rosiglitazone should be withdrawn from the market. Members voting for the first time were 4.4-times (95% confidence interval 1.1 to 17.0; P=0.01) more likely to vote that rosiglitazone be withdrawn from the market than were members who had voted previously to keep it on the market.”
“By inviting these former members to participate in the 2010 meeting, CDER biased the outcome of the vote in favour of rosiglitazone remaining on the market. Had these former members not been included, the vote would have been 10 out of 17 (59%) in favour of rosiglitazone withdrawal, with an additional three in favour of severely restricted distribution.”
If you or a loved one has suffered Avandia heart failure, stroke, heart attack or heart-related death after taking Avandia (rosiglitazone), you may be entitled to recover financial compensation and should contact an Avandia lawsuit attorney right away to discuss your legal rights and options.
Knowledge is power. Our experienced Avandia attorneys represent type 2 diabetics affected by Avandia and surviving family members of diabetics who have suffered heart-related death in Avandia lawsuit claims. Our lawyers currently are accepting Avandia lawsuit cases in all 50 states.
No fee unless we collect. We handle Avandia lawsuit cases on a contingency fee. There never are any legal fees or litigation expenses unless and until you receive financial compensation for your Avandia heart failure or a loved one’s wrongful death.
Let us help you recover the compensation you deserve.You may have a right to file a lawsuit claim to collect money damages for personal injury or wrongful death damages caused by Avandia. Drug company GlaxoSmithKline, the manufacturer of Avandia, has agreed to pay thousands of Avandia lawsuit settlements. We represent each client individually in filing an Avandia lawsuit, not as part of an Avandia class action lawsuit.
Get a free consultation. There is never any cost or obligation to talk to an Avandia lawyer who can help answer all of your questions.