Officials Consider Stopping Avandia Study

Washington, DCThe US Food and Drug Administration (FDA) is considering halting a safety trial of competing diabetes medications Avandia, made by GlaxoSmithKline (Glaxo), and Actos, by Takeda Pharmaceutical Co. Some experts have said it is unethical to compare Avandia, a drug known to increase the risk of heart attacks, with a drug that is reportedly safer.


The Wall Street Journal blog reported on 4/19/10 that if the FDA stops the trial, it will also consider asking Glaxo to stop selling the drug. No decision is likely to be made about whether or not to continue the trial, known as TIDE (Thiazolidinedione Intervention with Vitamin D Evaluation), until after officials meet in July to discuss Avandia.

A comparison between Avandia and Actos would require that patients take a drug with known risks. The FDA has requested that the Institute of Medicine, a government scientific panel, examine whether trials that compare the safety of one drug to another are appropriate.

In a letter to Senator Chuck Grassley of the Senate Finance Committee, FDA Commissioner Margaret Hamburg wrote that head-to-head safety trials can pose ethical questions. If one drug is less safe than another, "such a trial should not be conducted because it would place one group of patients at unnecessary risk," she wrote, as quoted in the Wall Street Journal.

A 2007 study by Dr. Steven Nissan suggested that Avandia users were at an increased risk of heart attacks and strokes. GlaxoSmithKline has defended the drug, saying it is an important option in treatment of diabetes. The company also noted that an independent monitoring committee has not yet expressed any concerns about the study.

Meanwhile, an editorial in the Journal of the American Medical Association cited a GlaxoSmithKline study of Avandia as a "disturbing example of the inappropriate conduct surrounding an industry-sponsored clinical trial." The editorial argued that research sponsored by the drug manufacturing industry should be analyzed by scientists with no ties to the company developing the product—and that the review should take place before the research is published.

According to Bloomberg on 3/23/10, Glaxo defended its studies as independently verified by researchers.

Patients who are currently taking Avandia should speak with their doctor if they have any concerns. They should not discontinue their medication without first consulting a doctor.