Both the New York Times and the Indianapolis Star are reporting that the approval of prasugrel may be delayed due to the congressional investigations into the “mistakes” the FDA admits having made in disinviting Sanjay Kaul from the advisory committee hearing last month. (CardioBrief was the first to report on this event. You can follow the complete chronology of events here.) The articles appear to rely heavily on a Cowen & Company analyst’s report, summarized in Barron’s, which also lowers its estimates of prasugrel’s eventual sales.
I have no way of knowing whether the Cowen analyst is right, but even the suggestion that prasugrel might be delayed raises some very important issues. Most notably: if prasugrel is delayed, who is to blame?
I suppose some people might blame CardioBrief, and other journalists from the New York Times to Heartwire and the blogosphere, for making an issue about Kaul’s absence in the first place. But it seems to me that the real blame lies with the FDA, and partly with Lilly (and perhaps others as well), who somehow thought that Kaul’s presence on the advisory committee represented a threat to prasugrel that somehow needed to be neutralized.
Let’s try a thought experiment: imagine for a moment that Kaul had not been disinvited and that he had participated in the committee meeting.
Of course he probably would have asked a lot of hard questions, and the tone of the advisory committee meeting might have been quite different. But it seems unlikely that the result would have been substantially different. When I first heard that Kaul would be on the committee I predicted (with no particular knowledge or evidence, of course) that Kaul would ask lots of very tough questions but that he would end up voting for the drug’s approval, though perhaps with a more restricted label than some would have liked. But even if he had voted against the drug, a 9-1 vote in favor of prasugrel would have still provided the FDA with a solid basis to approve the drug. More importantly, no one could have accused the FDA (or Lilly, or others) of silencing opposition to the drug.
Here’s another thought experiment: let’s assume for a moment that Kaul’s intellectual conflict of interest was a genuine concern. If this had been appropriately handled by the FDA, the late “disinvitation” would never have become an issue. More importantly, an enlightened FDA (please refrain from laughter here) might have said to itself: “well, Kaul’s previous statements about prasugrel disqualify him from participating, but since we caught this early enough we can arrange to find a substitute who shares a similar independent reputation and will ask equally hard questions.” So the late “disinvitation” not only removed Kaul but insured that his role would not be duplicated. (Let me hasten to add that I don’t for a moment believe that anyone at the FDA, or elsewhere, was nefarious enough to think that far ahead and plan it that way. This fiasco is a result of incompetence and insularity, not evil machinations.)
So far the FDA does not appear to have learned its lesson. CardioBrief has repeatedly asked the FDA to provide more information about the sequence of events that led to Kaul’s removal. In response, an FDA spokesman, Crystal Rice, wrote last week: “we will not be providing any further information or details at this time.”
This response is symptomatic of the FDA’s larger culture of insularity and lack of responsiveness and accountability. These are the problems that have nearly destroyed the FDA’s reputation in the past few years. The FDA needs to consider that adopting a position of forthright openness and availability could be the first step in helping resolve the many problems that have been beleaguering the FDA. To borrow a cliche: does the FDA want to be part of the problem or the solution?