FDA and Glaxo Share Blame for Avandia Disaster

FDA and Glaxo Share Blame for Avandia Disaster By Evelyn Pringle

On May 21, 2007, the New England Journal of Medicine reported a study that found GlaxoSmithKline’s diabetes drug Avandia is associated with a 43% increase in heart attacks and possibly a 64% increase in cardiovascular death. The NEJM said it posted the article online ahead of its June 6, 2007 print edition because of its medical importance.

Experts point out that the studies analyzed for the NEJM report were not designed to look for heart risks, many were only 24 weeks long, and it may be that higher risks will appear after a longer term of use. Dr David Nathan, chief of diabetes care at Massachusetts General Hospital, who reviewed the paper for the NEJM, told the Associated Press, “This analysis is just scratching the surface of what may be there.”

The FDA is going to have an extremely tough time wiggling out from under the rug of blame for this regulatory failure. The situation “reflects very badly on the FDA and on Glaxo,” Dr Nathan said. “It’s the FDA’s responsibility to be monitoring this stuff.”

In an editorial that accompanied the study in the NEJM, Dr Bruce Psaty of the University of Washington and Dr Furberg of Wake Forest University wrote: The drug “represents a major failure of the drug-use and drug-approval processes in the United States.”

They also state that “the rationale for prescribing rosiglitazone at this time is unclear,” because when the drug was approved its benefits were “at best mixed.”

In a memo dated May 22, 2002, submitted to the FDA by Dr. Wolfe and Larry Sasich for an FDA Hearing on Risk Management of Prescription Drugs informed the panel that a Glaxo-employed physician had contacted Public Citizen to report that the company was concealing reports of serious problems found with the drug.

“This week,” they informed the FDA at the time, “we received an anonymous call from a GlaxoSmithKline physician who was alarmed at the failure of his company to require a black box warning concerning heart failure caused by Avandia.”

“He maintained that the company currently has 450 reports of heart failure associated with the use of the drug and over 1200 reports of edema,” the statement said.

According to attorney, Karen Barth Menzies of Baum Hedlund, “The relationship between FDA and the drug industry is disturbing. We’ve seen internal correspondence between GSK and the FDA that would cause anyone to question the objectivity and regulatory effectiveness of the FDA. Apparently the FDA has failed yet again to protect the public – to the benefit of pharmaceutical industry profits. This failure, and FDA’s derogatory attitude towards Dr. Nissen’s study, should sound an alarm to all healthcare providers, patients and legislators that the problem is systemic. Patient safety commands serious change in the agency and the industry.”

And before anyone sends any “profitable anti-Avandia bandwagon” comments maybe they should ask themselves why it is that drug companies so often seem unable to develop drugs are safe and efficacious.

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