New England Journal of Medicine Prints Report Critical of GlaxoSmithKline Drug (Updated)

The Boston Globe reported today that a new study released early by the New England Journal of Medicine on its website questions the safety of one of the largest-selling diabetes medications in the country, Avandia.

Avandia, the world’s top-selling oral diabetes drug, significantly increases the risk of heart attacks, a prominent cardiologist said in an article that the New England Journal of Medicine deemed important enough to post on its website yesterday, weeks before the scheduled print publication date.

Dr. Steven E. Nissen, a cardiologist at the Cleveland Clinic and the article’s lead author, pored through summaries of dozens of studies and found a 43 percent higher risk of diabetics suffering a heart attack if they took Avandia compared with other drugs or sugar pills. Nissen was unable to determine whether the risk is affected by how long Avandia is used or how much is taken.

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“The leading cause of death in diabetes is heart disease. It causes between 65 to 80 percent of all diabetes mortality,” Nissen said in an interview. “When a diabetes drug, which is intended to reduce the risk of diabetes complications, actually increases it, it has profound public health consequences.”

In an accompanying editorial published by the New England Journal of Medicine, Bruce Psaty and Curt Furberg, doctors who are critics of the FDA’s drug-approval process, said there is little reason for doctors to prescribe Avandia….

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The drug is produced by GlaxoSmithKline, a major player in Big Pharma, and is worth over $$$3BIL$$$/year in sales worldwide. GSK immediately attacked the report, claiming it’s “flawed”.

That’s not particularly surprising, nor is it surprising that after the Vioxx debacle, the release of the report triggered a nosedive of GSK’s stock.

Since the Food and Drug Administration approved Avandia in 1999 doctors have written tens of millions of prescriptions for the drug. The Journal released the paper in advance of its June 14 print publication date partly because of its public health impact, according to executive editor Dr. Gregory Curfman.

Investors and others, including members of Congress, yesterday reacted strongly to the article.

GlaxoSmithKline shares closed at $53.18, down 7.85 percent, in heavy trading.

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The big question here is, “Where was the FDA?”