Senate, FDA reports increasing concerns about controversial diabetes drug

"Hundreds of people taking Avandia, a controversial diabetes medicine, needlessly suffer heart attacks and heart failure each month, according to confidential government reports that recommend the drug be removed from the market ... ," The New York Times reports. "The internal F.D.A. reports are part of a fierce debate within the agency over what to do about Avandia, manufactured by GlaxoSmithKline." Some within the agency think the drug should be withdrawn because "they believe there is a safer alternative." Others maintain that research so far is provides "contradictory information and that Avandia should continue to be an option for doctors and patients. GlaxoSmithKline said that it had studied Avandia extensively and that 'scientific evidence simply does not establish that Avandia increases' the risk of heart attacks. The battle has been brewing for years but has been brought to a head by disagreement over a new clinical trial and a Senate investigation that concluded that GlaxoSmithKline should have warned patients earlier of the drug's potential risks" (Harris, 2/19).

The Wall Street Journal: "The FDA is trying to assemble a timeline of what the FDA knew of risks associated with Avandia ... and plans to call a meeting of an outside advisory committee in the next few months to look at recent information on the drug, which Glaxo reported as having global sales of £771 million ($1.2 billion) in 2009. According to a two-year investigation by the Senate Finance Committee, Glaxo knew about data linking Avandia to elevated risk of cardiovascular events for several years, but played down the information and tried to suppress doctors who raised concerns" (Mundy, 2/22).

CNN: "The Senate committee investigation stems from concerns that Avandia and other high-profile drugs 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,' the report states" (2/22).

The Associated Press/Seattle Times: "In May 2007, the New England Journal of Medicine published an analysis of dozens of studies on nearly 28,000 people who had taken Avandia. The journal said there was a 43 percent higher risk of heart attack for those taking Avandia compared to people taking other diabetes drugs or no diabetes medication. The findings raised concerns because two-thirds of the people with Type 2 diabetes, the most common form, die of heart problems" (Ortutay, 2/21).

The Boston Globe: "In the 2008 report, the FDA safety officers also said that a medical trial comparing Avandia with Actos that was being planned would be 'unethical and exploitive' because it would expose patients to unwarranted risks. That trial, called TIDE, which was planned to involve a total of 16,000 patients, is now under way" (Waters, 2/21).

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This article was reprinted from khn.org with permission from the Henry J. Kaiser Family Foundation. Kaiser Health News, an editorially independent news service, is a program of the Kaiser Family Foundation, a nonpartisan health care policy research organization unaffiliated with Kaiser Permanente.