Heart Attack Worries Led FDA Staffers to Urge Avandia Removal
As the debate over the safety of diabetes drug Avandia continues, confidential reports from within the Food and Drug Administration reveal an effort by some within the agency to have the drug removed from the market, the New York Times reports.
As the article notes, a multi-million dollar advertising campaign by the drug’s maker GlaxoSmithKline helped catapult it into one of the best selling drugs worldwide. In 2006, sales of Avandia reached $3.2 billion.
But in 2007, a study linked Avandia to heart damage and heart attacks. That same year, the FDA issued a warning about the potential dangers. But in an 8-7 vote, the FDA’s oversight board allowed Avandia to stay on the market.
Even though the drug was not pulled from the market, there were those inside the federal agency who were calling for its removal. An internal memorandum written by Dr. David Graham and Dr. Kate Gelperin of the FDA in 2009 claimed that if every patient taking Avandia were switched to Actos, a similar drug, “about 500 heart attacks and 300 cases of heart failure would be averted every month.”
And the same two doctors warned in 2008 that a GlaxoSmithKline study called TIDE was “unethical and exploitive.” That study involved enrolling diabetic patients to study the risks associated with Avandia.
The memorandum warns:
“Although the proposed TIDE trial is motivated by a desire for definitive answers regarding the cardiovascular safety of the drug rosiglitazone, the safety of the study itself cannot be assured and is not acceptable.”
According to the New York Times, Glaxo is currently enrolling patients in the study, which is not expected to be completed until 2020. Glaxo hopes to report some preliminary results in 2014.
If you or a loved on suffered a heart attack after taking Avandia, contact the attorneys of Carey, Danis & Lowe. We can help. Carey, Danis & Lowe is a national law firm that represents individuals injured by America’s largest corporations.
