FDA provides “explanation” for Sanjay Kaul’s absence

In response to a query from CardioBrief.Org about Sanjay Kaul’s absence from the prasugrel advisory committee meeting (click to see our initial story that first reported his absence and our subsequent editorial about some serious questions raised by the advisory committee meeting), an FDA spokesperson has provided an explanation for Kaul’s absence:

“One thing I’d like to clarify regarding Dr. Sanjay Kaul is that the FDA wants to make it very clear that no determination was ever made that Dr. Kaul had any conflict of interest, there simply was not time to make a determination before he had to travel in for the meeting.  The FDA did not receive sufficient information until much later than we would prefer, very late in the process, and the agency was unable to go through the review process in sufficient time in order to make a decision on the member’s participation in the meeting. Thus, in this case, in order to enhance the credibility and transparency of the advisory committee proceeding and in an abundance of caution, the agency felt it was necessary for the member not to participate in this meeting.”

     –Sandy Walsh, FDA Office of Public Affairs

I am particularly confused by the statement that the “FDA did not receive sufficient information until much later than we would prefer…” It is my understanding that committee members undergo a very detailed and rigorous review process over a period of several months. If this process did not take place with Dr. Kaul, how was it that he was appointed to the committee?

I also don’t understand the remark that Kaul did not participate in the meeting “in order to enhance the credibility and transparency of the advisory committee proceeding and in an abundance of caution…” It seems to me that an equally credible argument could be made that the credibility and transparency of the meeting was harmed by his absence.