F.D.A. Scientist Warns Of Heart Risk From Diabetes Drug Avandia
A federal drug safety official recommended during an advisory committee hearing today that Avandia, a controversial diabetes medicine made by GlaxoSmithKline, be withdrawn from the market because it increases heart risks.Dr. David Graham noted in a written preview of his presentation that Avandia is no better at controlling blood sugar levels than similar diabetes medicines like Actos, made by Takeda. With a clear risk to the heart, and nothing to recommend it over other therapies, Avandia should be withdrawn, Dr. Graham argued in written remarks.
Dr. Graham is scheduled to speak to the committee later today. But it is not clear that the advisory committee, or indeed the Food and Drug Administration itself, will agree with Dr. Graham, a drug safety official at the F.D.A. who has a long history of arguing against the use or marketing of some widely-used drugs.
The committee may instead recommend that Avandia’s label include stronger warnings about its heart risks.
A committee vote is scheduled for later this afternoon.
The F.D.A. called the advisory committee meeting today after a study, published in May in the New England Journal of Medicine, called into question the safety of Avandia.
Since then, the controversy about Avandia has wounded GlaxoSmithKline and led to severe criticism of the F.D.A., which has known for a year that Avandia might increase the risks of heart attacks but waited until May to warn patients about a possible risk.
This delay has helped to push through legislation on Capitol Hill that would provide the F.D.A. with more authority and money to police the safety of marketed medicines. Both the House and Senate have passed F.D.A. reform bills but a conference committee has yet to come to agreement.
About a million patients in the United States took Avandia last year, and a similar number took Actos. Since May, Avandia’s sales have plunged.
Many patients who take Avandia, and their doctors, have been presented with conflicting advice about whether to switch to other drugs.
The controversy largely revolves around whether several highly complex statistical analyses of dozens of studies of Avandia have shown that the drug is too dangerous to use.
There are fierce disagreements about the answer to this question not only among academic experts but within the F.D.A. itself.
The heart attack risk comes on top of a problem with swelling that has long been known to occur in those taking both Avandia and Actos. The swelling is especially risky for patients suffering from heart failure.
GlaxoSmithKline argued forcefully before the committee that its drug is safe.
Dr. Murray Stewart, a GlaxoSmithKline vice president, said that in recent months the company has examined data from several large managed care companies in the United States that altogether included 1.35 million diabetes patients.
The company’s analyses, he said, showed that patients who took Avandia suffered no greater risk of heart attack or death from heart problems than those taking other diabetes medications, including Actos.
The hearing began today with a presentation by Dr. Robert Ratner of the MedStar Research Institute in Washington, about the epidemic of diabetes.
He noted that each day in the United States, there are 4,100 new cases and 810 deaths from diabetes. In addition, 230 patients suffer amputations, 120 suffer kidney failure, and 55 go blind because of the disease every day.
He said that while controlling blood sugar levels has proven health benefits in the short term, no study has proved that diabetes drugs extend lives.
“We’re not keeping people alive with our drug therapy because our drug therapy isn’t adequate,” he said. And he said that no diabetes medicine has conclusively proven that it helps protect the heart. He also noted that diabetes patients often fail to take their medicines properly, and doctors often fail to treat the disease aggressively enough.
“Why do we need new therapies for type two diabetes?” Dr. Ratner asked. “We have an epidemic of diabetes and its complication that will soon swamp our medical delivery system.”
Most diabetics die from heart disease, since diabetes has severe effects on the heart. If Avandia actually increases the risks of heart attacks, that “denotes a serious limitation” of the drug’s usefulness, an F.D.A. reviewer concluded in a report before the meeting.