Chapel Hill doctor warned FDA of Avandia concerns in 2000
Letter to agency alleges company manipulated trial data
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On March 15, 2000, Director of the Diabetes Center at the University of North Carolina at Chapel Hill John Buse sent a letter to the U.S. Food and Drug Administration (FDA) voicing his concerns about Avandia’s safety.
In his letter, Dr. Buse outlined his concerns about the adverse cardiovascular effects of Avandia. He even said that he rarely prescribed the diabetes drug to his own patients.
Dr. Buse alleges that GlaxoSmithKline, then named SmithKline Beecham, rampantly abused clinical trial data. Dr. Buse goes so far as to say the company blatantly manipulated the data from trials to conceal information about the drug that may imply it is unsafe.
“I am sure there have been abuses by representatives of all companies that market drugs,” Buse wrote, “but there is something pervasive and systematic that I detect in my travels regarding the marketing of rosiglitazone,” the generic name for Avandia.
On May 21, 2007, a study published in the New England Journal of Medicine raised questions about the safety of Avandia Dr. Steven Nissen with the Cleveland Clinic analyzed 42 clinical trials involving the drug and concluded the drug increased the risk of heart death by 64 percent and the risk of heart attack by 43 percent.
GlaxoSmithKline released a statement saying it “strongly disagreed” with both Buse’s statements and Nissen’s study. The company is now testing a11 other drugs in the same family as Avandia, all of which could be tainted if suspicions about the cardiovascular risks associated with them rise.
Analysts have drawn parallels between Avandia and Merck & Co.’s Vioxx, a painkiller recalled in 2006 after it was linked to heart attacks and deaths. The drug was recalled, causing a ripple effect relating to other, similar painkillers.
The FDA has not issued an Avandia recall.
Source: Chris Coletta, “UNC doctor warned FDA about Glaxo drug years ago,” Triangle Business Journal, May 23, 2007; Letter from John B. Buse to Food and Drug Administration, March 15, 2000; Sabine Vollmer, “GSK’s Avandia problem may grow,” New and Observer, May 25, 2007.
