GlaxoSmithKline Hid Negative Avandia Data: Lawmakers
July 13, 2010— -- WASHINGTON -- GlaxoSmithKline, maker of rosiglitazone (Avandia), hid negative trial results on the controversial diabetes drug more than a decade ago, according to a report released by the Senate Finance Committee.
Rosiglitazone was approved by the U.S. Food and Drug Administration in 1999 to treat type 2 diabetes. But "as far back as 2000, internal e-mails show that GSK executives sought to downplay scientific findings, which raised questions about the safety [of the drug]," the committee wrote, citing an internal memo about a trial comparing rosiglitazone to pioglitazone (Actos) that found rosiglitazone presented a "worse lipid profile" than its competitor.
In another e-mail, sent on July 20, 2001, a GlaxoSmithKline executive, discussing the negative data wrote "we would hope that these do not see the light of day."
Controversy over the drug began three years ago when a 2007 review of data from 42 clinical trials found a 43 percent increase in risk of heart attack among patients treated with rosiglitazone.
Since then, debate has raged over the safety of the drug, and the data have often seemed contradictory at worst and difficult to sort through at best.
The company had projected that if the poor study results went public, GlaxoSmithKline stood to lose $600 million from 2002 to 2004, according to a document obtained by the New York Times.
The paper obtained a sealed deposition that indicated an FDA official -- Dr. John Jenkins, director of the agency's new drugs office -- briefed GlaxoSmithKline on the FDA's internal debate, and told the company his department was "trying to find minimal language that will satisfy the office of drug safety."
In 2007, Congress mandated that drug companies disclose negative trial findings.
According to GlaxoSmithKline spokeswoman Mary Anne Rhyne, the documents reported in the New York Times were obtained from the Senate Finance Committee, which has been investigating rosiglitazone for several years.
