A group of doctors today filed suit against the Food & Drug Administration for failing to alert diabetes patients to safer alternatives to Avandia and other diabetes drugs that may increase the risk of stroke, heart attack and death.
The suit, filed in U.S. District Court for the District of Columbia by the non-profit Physicians Committee for Responsible Medicine, faults FDA Commissioner Margaret Hamburg for declining to act on the group's 2007 petition.
The petition urged the FDA to require diabetes drugs to carry a warning label telling patients that a low-fat, plant-based diet can be as effective or better than drugs in reducing blood glucose and cholesterol.
“People are getting sick and sometimes dying because they are taking a medicine they may not even need,” said Daniel Kinburn, who is general counsel of the Physicians Committee for Responsible Medicine. “A low-fat, vegan diet is clearly safer and at least as effective.”
The group in its petition asked the FDA to require labeling disclosures about the effect of diet on diabetes and to advise consumers and doctors that “oral medications are not always necessary to manage diabetes.”
But Kilburn said the FDA failed to provide a substantive response to the petition in a reasonable time, in violation of the Administrative Procedure Act. Instead, all the FDA did was issue an “interim response” in which it stated it had been “unable to reach a decision” about the petition, according to the complaint, which was filed by Kilburn.
The suit asks the court to order the FDA to respond to the petition, and to award the Physicians Committee attorney fees and costs.
The risks from Avandia first became public in May 2007. The New York Times reported today that drugmaker SmithKline Beecham (now GlaxoSmithKline) had data hinting at Avandia’s extensive heart problems almost as soon as the drug was introduced in 1999.
The FDA is currently reviewing the drug, and is holding a special joint meeting of two advisory panels today and tomorrow to determine whether to pull Avandia from the market.
GlaxoSmithKline faces more than 13,000 suits for hiding the drug’s heart attack risks. Bloomberg reported today that the company will settle 10,000 cases for $460 million.