Medicare patients who took GlaxoSmithKline’s Avandia drug for diabetes between 1999 and 2009 may have suffered as many as 48,000 instances of heart attack, stroke and heart failure that could have been avoided by using another drug, according to an unpublished study co-authored by a Food and Drug Administration scientist.
The scientist, David Graham, is a longtime critic of Avandia and released the draft study to the blog Pharmalot Thursday, contending that the FDA had obstructed his efforts to publish it. An FDA official told The Wall Street Journal that the agency did not hold up the study’s publication. An FDA review of Avandia is scheduled for next month and will include Graham’s report, an official said.
The study surveyed the Medicare records of 227,571 patients aged 65 and older who took either Avandia, or the competing drug Actos. Risks for the Avandia group were 27 percent higher for stroke, 25 percent higher for heart failure, and 13 percent higher for death than for patients on Actos. Overall, patients who used Avandia had a 17 percent increased risk of experiencing either heart attack, stroke, heart failure or death.
“There is no rationale for [Avandia's] continued availability on the market or its use by prescribing physicians or patients,” the study concludes.
In an e-mailed statement to The Wall Street Journal, Glaxo said it was “unclear whether this study has been peer-reviewed, and until then, it would be premature to comment.” The company also said six clinical trials showed Avandia ”does not increase the overall risk of heart attack, stroke or death.”
Glaxo has settled about 5,000 lawsuits with patients who claimed the drug caused heart attacks. In February, the Senate Finance Committee published the results of a two-year investigation that said Glaxo knew about Avandia’s risks years before the information became public, but downplayed them by pressuring doctors to retract criticisms and by spreading misinformation. The investigation also found the FDA had allowed clinical trials of the drug to continue, even though the agency has acknowledged that Avandia caused as many as 83,000 heart attacks between 1999 and 2007.
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