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."
Avandia (rosiglitazone) was FDA approved in 1999 for the treatment of type 2 diabetes, a disease that affects between 18 to 20 million Americans.
When approved, Glaxo promoted Avandia as being safer than Rezulin, a diabetes drug removed from the market in 2000 after serious cases of liver damage developed in patients taking the drug.
Avandia is currently the top selling diabetes drug with total US sales of $2.2 billion in 2006, according to IMS Health, a healthcare tracking information firm. A one-month supply sells for between $90 and $170, the Associated Press reported on May 23, 2007.
"More than 6 million people worldwide," the Associated Press reports, "have taken the drug to control blood sugar since it came on the market eight years ago, and about 1 million Americans use it now."
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."
Documents dating back 7 years show the FDA knew about the risks associated with Avandia and did nothing to protect consumers. The day after the new study appeared online, on May 23, 2007, Dr Sidney Wolfe, director of Public Citizen, a non-profit health research group, sent a letter to FDA Commissioner Andrew von Eschenbach, which described a July 16, 2002 FDA memo that showed FDA scientists had recommended that the label for Avandia be amended to include post-marketing reports of heart failure among patients taking the drug.
"The failure of the FDA to act on the recommendations made almost five years ago by its Division of Drug Risk Evaluation is yet another case in which the conclusions of scientists who are engaged in post-market drug safety review are not taken seriously enough or addressed soon enough," Dr Wolfe said in a press release.
"As a result," he stated further, "millions of people – to the detriment of their health – are prescribed drugs whose risks are dangerously understated, instead of being prescribed safer, equally or more effective alternative drugs."
According to the memo, in July 2002, the FDA had 25 adverse reaction reports in which the use of Avandia resulted in hospitalization for heart failure. By the fall of 2006, the number of cases had increased to 415, Public Citizen reports.
Another 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, "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.
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