Outspoken critic: prasugrel hearing was a “family picnic”

Victor Serebruany, a well-known platelet researcher who has consulted for many companies, including Sanofi-Aventis (makers of clopidogrel), and a patent application holder on prasugrel with Lilly, spoke to CardioBrief and expressed strong feelings about the advisory committee meeting. He was critical of the meeting, calling it a “family picnic,” because in his view the outcome was predetermined. “There was no need for the meeting since it seems as if it was already decided,” he said.

Serebruany pointed to a number of serious issues raised…
…by the FDA reviewers in the 357 page document, but deliberately avoided in the Deputy Director presentation. Serebruany said the definition of MI changed during the course of prasugrel development, the cancer rates were much higher than reported, and the net clinical benefit was overestimated.

Serebruany emphasized that he was not necessarily opposed to the drug’s approval. “It is only now that we have the FDA review document and access to the full data that we can start talking about the real benefits and risks of this drug,” he said.

Update (12:50 PM): The ACC released the following statement on its website:
ACC President Comments on Prasugrel
ACC President Douglas Weaver, M.D., F.A.C.C., provided public comments at the Feb. 3 meeting of the Food and Drug Administration’s Cardiovascular and Renal Drugs Advisory Panel on a new drug application for prasugrel hydrochloride. The panel voted unanimously to approve prasugrel’s use to treat patients with ACS presenting with either unstable angina/NSTEMI or STEMI. In his comments, Dr. Weaver said that studies have found the effectiveness of prasugrel in reducing the rates of recurrent non-fatal myocardial infarction, rehospitalization for ischemia and stent thrombosis is clinical meaningful. However, he said that “if the drug is approved, additional studies should be conducted to ensure its safety and to ensure that it is prescribed to those patients who might benefit,” which can be completed most prudently through a post-market registry outside of the manufacturers’ typical post-market analyses.

Update (February 5, 10:30 AM): Frans van de Werf provided the following perspective: “In view of the  results of TRITON, especially the reduction in the risk of stent thrombosis, the approval will be welcomed by many invasive cardiologists. For a of broader use of this agent we probably have to wait for the results of the TRILOGY study.”

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  1. […] vote, wouldn’t the committee have benefited from his expertise as a nonvoting member? Other outspoken experts have criticized the FDA hearing for having the atmosphere of a “family picnic…  At the very least, inclusion of someone like Kaul in the proceedings would have allowed the FDA […]

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