2 new studies add to evidence of risks with diabetes drug Avandia as FDA prepares to debate it's safety

Jun 30 2010

The Washington Post: Two new studies provide evidence "that the diabetes drug Avandia increases the risk of heart problems and strokes, renewing questions about the safety of the medication. ... The new research, released Monday, should prompt the Food and Drug Administration to remove the drug from the market, according to the researchers who led the analyses and several drug-safety advocates. … In a statement, GlaxoSmithKline, which makes Avandia, stood by the medication, saying many other, more reliable studies have found no evidence the drug is unsafe. The studies that found no risk were better designed and therefore more reliable, the company says … Avandia had once been one of the world's most popular drugs, with sales exceeding $3 billion annually" (Stein, 6/29). 

The Wall Street Journal: The studies were published by the Journal of the American Medical Association and another AMA journal, the Archives of Internal Medicine. "They come two weeks before an important Food and Drug Administration meeting on Avandia's safety. In releasing the papers together, a JAMA spokeswoman said the editors 'hope the peer-reviewed scientific studies will have some impact on the FDA's discussions about the safety of this medication.'" 

The Journal also points out that the controversy over Avandia is part of a "battle inside and outside the FDA" over how the agency  deals with safety questions once drugs are on the market. Some researchers "say the FDA insists on too high a standard for withdrawing a drug from the market. They say the FDA should have a separate drug safety division independent of the drug-approval section. ... The head of the FDA's drug division, Janet Woodcock, has defended Avandia's safety and said its benefits still outweigh its risks. The FDA is now reviewing its drug approval and safety procedures" (Mundy and Dooren, 6/29).

The Los Angeles Times: Avandia, "also known by its generic name, rosiglitazone, was approved in 1999 to help people with Type 2 diabetes control their blood sugar. At the time, it was considered a safer alternative than existing diabetes drugs used instead of insulin." But concerns about the drug developed soon afterward (Roan, 6/29).

NPR: The issue of Avandia raises questions about the Obama administration's "philosophy on these hotly contested public safety calls. ... The issue has sharply divided FDA staffers. In late 2007, the agency's Drug Safety Oversight Board -- a panel that does not meet in public nor disclose its deliberations -- voted 8-to-7 to keep Avandia on the market" (Knox, 6/29).

The Hill: "Sen. Chuck Grassley (R-Iowa) and Rep. Rosa DeLauro (D-Conn.) on Monday called for the diabetes drug Avandia to be pulled from the market in the wake of two new medical studies." Both have raised questions before about the FDA's oversight on the drug (Pecquet, 6/28).

In a separate article, The Los Angeles Times reports on three new studies looking at the use of statins, drugs commonly used to lower the risk of heart attack or stroke. "A meta-analysis — a review of previous studies — published in the Archives of Internal Medicine found that statins do not lower death rates among patients with risk factors but no evidence of established cardiovascular disease who take them as a preventive measure. ... At the same time, a study in the journal Cancer suggests that for men who have undergone surgery for prostate cancer, statin use appears to reduce the chance that the disease will return. … [A] third study released Monday characterized as 'flawed' a widely hailed 2008 study that appeared to establish the benefit of the statin rosuvastatin (commercially marketed as Crestor) in the prevention of heart attack and stroke" (Healy, 6/29).