The Food and Drug Administration is charged with protecting the public health, but some of its recent actions raise serious questions about drug safety. One puzzle is its shifting stance on the diabetes drug rosiglitazone (Avandia).
Several years ago Avandia was aggressively marketed and widely prescribed. In its heyday, it earned over $3 billion a year, making it the most successful diabetes drugs of all time.
Then cardiologist Steve Nissen, MD, published an article in the New England Journal of Medicine (June 14, 2007) revealing a 43 percent increased risk of heart attack among patients taking Avandia.
Avandia immediately became a highly controversial medication. According to Dr. Nissen, the company and the FDA were aware of potential cardiovascular problems associated with Avandia even before he published his critical article. The FDA eventually restricted use of the drug, which was banned outright in Europe.
That might have been the end of the story, but the agency and the manufacturer, GSK, requested a reanalysis of a European study of Avandia. The researchers concluded that there was no increased risk of heart attacks after all. The FDA convened an advisory committee to hear this report, and this panel suggested that the restrictions on Avandia be loosened.
Has the FDA lost sight of the reported suffering that has been associated with this drug? One reader wrote:
“I have been a type 2 diabetic since 2001 and have been on metformin since 2002. Along with diet and daily exercise, it has managed my condition very nicely.
“In 2005 my 44-year-old son was also diagnosed with type 2 diabetes. His health needs were met by his company’s health plan. For some reason he was put on Avandia.
“He had a massive heart attack and died on Oct. 13, 2006, at age 45. I asked his wife what his medications were and she said he was taking Avandia. Why he was put on that drug immediately upon being diagnosed I will never understand. A good physician usually tries the trusted drugs that have been on the market for a while. I believe that my son was one of the first guinea pigs to die because of Avandia.
“I also hold the FDA responsible in that (1) they approved a drug before the long-term effects were known, and (2) they failed to even listen to the drug manufacturer when warned of a serious side effect.
“I continue to tell everyone I know about Avandia. I will also refuse to take any new drug until I know what the long-term side effects are. I no longer trust the FDA.”
It can take years or even decades for the FDA to discover serious side effects of commonly prescribed medications. The pain reliever propoxyphene (Darvon, Darvocet), the weight loss medicine sibutramine (Meridia) and the arthritis drug rofecoxib (Vioxx) were taken by millions of people before it was discovered that each increased the risk of heart attacks or strokes. They eventually were pulled off the market.
European drug regulators do not appear to be reconsidering the ban on Avandia. It remains to be seen whether the FDA will ease restrictions on this controversial drug. If the FDA wants to keep the confidence of the American people, it must put the public health uppermost in its Avandia deliberations.
