Avandia Heart Attack Risks News

Recruiting Lags For Avandia Drug Trial

-Wall Street Journal

05/20//2010 - GlaxoSmithKline PLC is facing difficulties recruiting patients in the U.S. for a large clinical trial of its diabetes drug Avandia, in the wake of several studies linking the medicine to an increased risk of heart attack.

Two sites have recently withdrawn from the safety study because of poor enrollment, according to Glaxo.

One of them, Wake Forest University Baptist Medical Center in North Carolina, is "not succeeding in recruiting anybody," although efforts to enlist patients began last year, said William Applegate, dean of Wake Forest's medical school.

Meanwhile, Glaxo has been adding sites in several developing nations. Safety advocates and some regulators have said the trial, called TIDE, is unethical because patients are being given a drug already linked to serious cardiovascular problems.

Glaxo said any major safety problems are unproven and called Avandia a valuable option for some patients. TIDE compares cardiovascular risks for Avandia and its top competitor. Avandia and Takeda Pharmaceutical Co.'s Actos aim to help diabetics control their blood sugar.

U.K.-based Glaxo said patients in the trial sign informed-consent forms that describe potential side effects. An independent committee of experts is monitoring patient safety, the company said. Glaxo didn't name the second U.S. site that withdrew.

Dr. Applegate said Wake Forest's decision was "totally disconnected" from the safety debate and "didn't have to do with the drug." He said Wake Forest pulled out a month ago because it was struggling to find subjects.

The U.S. Food and Drug Administration said in a recent letter to Congress that it is weighing whether to end the trial early, and has set up a meeting of outside advisers in July to review the drug's safety and questions about TIDE. In addition, the agency has commissioned an internal report on ethical guidelines in clinical trials, which FDA leaders said will be relevant to the July meeting.

Avandia has been on the market since 1999, but since 2007 has come under fire in several medical studies, one of which linked the drug to a 43% increase risk of heart attacks. Earlier this year, a Senate report critical of the FDA and Glaxo reignited the safety controversy and prompted the agency to call the July meeting.

Glaxo opened up dozens of new sites overseas in April, including many in developing nations, according to Sidney Wolfe of Public Citizen, a Washington consumer group that often criticizes pharmaceutical companies. The U.S. government website clinicaltrials.gov shows that TIDE has sites in Pakistan, India, Mexico, Latvia and Colombia, among other places.

Dr. Wolfe said it is "particularly troublesome" that Glaxo had added so many sites in countries where patients may not be aware of the safety questions about Avandia.

A company spokeswoman said the locations were approved by regulators and ethics overseers.
Some officials at the FDA have written in reports that TIDE is unethical. They say it is wrong to conduct a study that they describe as actively looking for negative side effects.

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