The FDA's prasugrel hearing was "breathtakingly incompetent"

CardioBrief's Larry Husten writes:

As a journalist and editor who’s covered the cardiovascular arena for more than 25 years I’ve tried as much as possible to avoid taking positions on the major controvesies that have appeared over the years. I’m proud that during the “TPA wars” I remained on good terms with not only Eric Topol, Rob Califf and Eugene Braunwald, but Peter Sleight, Charlie Hennekens, and Gianni Tognoni. More recently, as we’ve been engulfed by the Vioxx, Vytorin, and COURAGE controversies, among others, I’ve been pleased to maintain good working relationships with all the mainstream protagonists.

I have no intention of breaking this tradition over prasugrel.

The players in this drama are all far smarter about this kind of stuff than I could ever hope to be, and the subtle statistical and clinical issues are extremely difficult to evaluate and assess. But there is one aspect of the prasugrel story that I do feel competent to comment upon.

The FDA handling of this hearing was breathtakingly incompetent.

Let me explain:

As first reported here previously, less than 48 hours before the advisory committee hearing new member Sanjay Kaul was “uninvited” from the meeting. Now I’m no expert on the criteria for serving on FDA advisory committees, and it’s possible that Kaul’s previous statements represented a legitimate reason for excluding him, but there is absolutely no reason for this to have been done immediately prior to the meeting. It’s not like Kaul was hiding anything. Any reasonable exercise of due diligence– just google “Kaul and prasugrel and you’ll see what I mean– would have revealed his outspoken position. Since Kaul was removed so close to the meeting, and after publication of the roster, FDA officials need to publicly apologize to Kaul and to provide a full explanation for the reasons for his dismissal, and in fact provide an account for the entire sequence of events leading to this last minute debacle.

It’s also not clear what constitutes “intellectual conflict of interest.” But even if there were general agreement that Kaul’s previous positions disqualified him to 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 to escape the charge of cronyism and disregard for dissent.

I’m also surprised that there has been little public discussion about the FDA briefing document, which contained apparently redacted content that was easily recovered in the PDF document originally posted on the FDA website. One important point here: some of the redacted content in the document, which appeared to contain information that might have identified patients in clinical trials, or genuine trade secrets, was fully scrubbed from the PDF document and was not recoverable. The recoverable content was more “political” in nature, and appeared to represent a last minute, incompetently executed attempt by top managers at the FDA to stifle opposing views. This pathetic effort to create a sense of unity appears to be typical of the type of managerial problems that have beset the FDA in recent years.

I can’t say for sure whether the prasugrel hearing is a demonstration of intellectual dishonesty or corruption. But I think I can say for sure that it is certainly a clear demonstration of incompetence.

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