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FDA Should Reject Drug for Preventing Blood Clots, Public Citizen Tells Advisory Committee

Feb. 12, 2014

FDA Should Reject Drug for Preventing Blood Clots, Public Citizen Tells Advisory Committee

Unethical Trials Failed to Provide Substantial Evidence That Cangrelor Is Effective

WASHINGTON, D.C. – The U.S. Food and Drug Administration (FDA) should not approve cangrelor, a treatment designed to prevent blood clots during heart artery-clearing angioplasty and stenting procedures, Public Citizen said today.

Testifying today before the FDA’s Cardiovascular and Renal Drugs Advisory Committee, Dr. Michael Carome, director of Public Citizen’s Health Research Group, strongly urged the committee to reject cangrelor, which is made by The Medicines Company, because the clinical trials conducted to test the medication were poorly and unethically administered.

During the main clinical trial, many of the people in the control group received substandard care, and as a result, the trial failed to provide substantial evidence that the medication is effective relative to treatments recommended by expert guidelines, Carome said. For example, subjects randomly assigned to the control group received the drug clopidogrel. This medication is routinely given before cardiac stent procedures begin to prevent clot formation in the stent and heart attacks during the procedure. However, many subjects received the medication after the conclusion of the procedure, likely resulting in a larger number of clots and heart attacks in control subjects during or immediately after the stent procedure.

The fact that the subjects were given substandard care also made the trial unethical. In addition, the consent forms at some trial sites failed to adequately describe to subjects the risks of participating in the trial relative to guideline-recommended care or to inform subjects of alternative courses of treatment that might be more effective.

“The FDA’s own lead medical reviewer wrote a scathing review and recommended that the drug not be approved because he considered the three major trials to be insufficient to prove the drug’s effectiveness, as well as unethical,” Carome said. “Public Citizen agrees and urges the FDA to follow the recommendations of its most knowledgeable experts and reject the approval of this treatment.”

Read today’s testimony.