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Subscribe To Our Syndicated NewsPublic Citizen Joins Avandia Debate
The watchdog group Public Citizen has released a 2002 internal memo from the FDA that cited 25 cases of heart failure linked to the diabetes drug Avandia, adding fuel to the controversy that developed this week when The New England Journal of Medicine (NEJM) published a meta-analysis of Avandia studies describing a significant increase in the risk of heart attacks and heart-related deaths among Avandia users.
The director of Public Citizen's Health Research Group, Sidney Wolfe, also pointed out that the FDA has been in possession of similar data provided by GlaxoSmithKline, the maker of Avandia, for a year. In contrast, the authors of the NEJM analysis needed only six days to complete their data review.
Foot-Dragging by the FDA?
Critics of the FDA liken the Avandia issue to the Vioxx and Rezulin safety recalls, contending that the FDA is not doing an adequate job of protecting consumers from unsafe drugs, in part because the FDA relies heavily on funding from the pharmaceutical industry it is supposed to be regulating. Wolfe stated that "These people (at the FDA's Center for Drug Evaluation and Research) just are not as willing as they should be or would be if they weren't funded so heavily by the industry to act on evidence-based recommendations."
After the May 21 NEJM report, the FDA issued a Safety Alert to physicians and consumers about Avandia's 30 to 40 percent higher risk of heart attack. However, the FDA said that the agency is still analyzing all available study results before reaching its own decision about the drug's heart risk, and that the issue will be taken up by an FDA advisory committee soon.
Avandia's Maker Revealed the Same Risk
GlaxoSmithKline had conducted its own meta-analysis of Avandia studies and found the same 30–40 percent increase in heart attacks and heart-related problems. Glaxo submitted that conclusion to the FDA nearly a year ago.
(Source: United Press International)
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