FDA Bars New Patients From Avandia Study

Those already in the trial for the controversial drug may remain, for now.

ByABC News
July 21, 2010, 2:29 PM

July 21, 2010— -- WASHINGTON -- The U.S. Food and Drug Administration has ordered GlaxoSmithKline, the maker of Avandia (rosiglitazone) to stop enrolling patients in its ongoing head-to-head trial comparing the drug with rival Actos (pioglitazone).

Patients currently enrolled in the trial, called TIDE, can continue to participate, the FDA said in a statement posted to its website.

The decision comes after a 19-11 vote last week by the agency's expert advisory panel to keep the trial open. That vote came after the panel voted 20-12 to recommend the FDA allow Avandia to remain an option for patients with type 2 diabetes, despite an increased risk of heart problems associated with the drug. Most panelists want to see the controversial diabetes drug carry tougher warnings on its label.

The FDA required GlaxoSmithKline to conduct the TIDE trial following the agency's advisory committee in 2007 voting to keep Avandia on the market but beef up safety warnings. Practically since the beginning, the trial has been hampered by sluggish enrollment, possibly because of safety concerns.

In briefing documents released in advance of last week's advisory committee meeting, FDA reviewer Dr. David Graham called the trial "unethical and exploitative," as its main purpose is to look for safety issues with Avandia. He also said the informed consent form for the trial obscures the risks of Avandia while focusing too heavily on a more innocuous portion of the study -- a piece designed to detect vitamin D's affect on cancer.

Graham argued that the trial should be shut down.

"Is it ethical to enroll patients in a clinical trial where the goal is to prove harm?" he asked during last week's joint meeting of the Endocrinology and Metabolic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee.