Heartwire story provides most detailed account yet of prasugrel hearing

A story in Heartwire by Michael O’Riordan has provided the most detailed account yet of the issues surrounding the FDA’s prasugrel hearing. The story quotes FDA officials, panel members, and outside observers such as William Boden, who said the absence of Sanjay Kaul “raises some obvious red flags.”
John Jenkins, the FDA director of the Office of New Drugs, explains that Kaul’s eligibility had not been thoroughly examined by the FDA, though not due to any fault of Kaul’s, who fully disclosed all “necessary information” to the FDA. However, Jenkins statements in the story make it clear why Kaul was really disqualified: “we want the committee members to come to the table with an open mind, so they can give us advice based on the data, the presentations, and the discussions that are held at the committee meeting itself.” Kaul’s publications critical of prasugrel trials “constituted an intellectual bias,” according to Jenkins.
Steve Nissen notes that eliminating a critic like Kaul “undermines the credibility of the panel.”
The Heartwire story also includes detailed discussions of the controversy over the issue of a cancer warning for the drug, and of the definition of MI used in the trials.

Speak Your Mind

*