Healthy Skepticism Library item: 15974

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Publication type: news

Goozner M.
FDA Admits Error in Kaul Case
GoozNews 2009 Jul 11
http://www.gooznews.com/node/3001

Full text:

The Food and Drug Administation has admitted it acted improperly in excluding Sanjay Kaul from its Feb. 3 Cardiovascular and Renal Drugs Advisory Committee meeting after receiving a complaint from Eli Lilly. The admission of error came in a letter to Rep. Maurice Hinchey (D-NY), who has spearheaded efforts to limit conflicts of interest on FDA advisory committees.

“Dr. Kaul’s removal from the prasugrel advisory board underscores the underlying problem of FDA officials having inappropriately close ties to drug industry representatives,” Hinchey said in a press release. “I appreciate FDA’s candor in admitting that a mistake was made, but that admission begs the question of what steps they are taking to reprimand the staff members who were responsible for preventing a well-respected doctor from participating on an advisory panel and to ensure that a similar situation doesn’t happen in the future.”

The FDA admission was contained in a letter drafted by acting assistant commissioner for legislation Stephen Mason. He blamed lower level officials for failing to follow proper procedures.

The FDA removed Kaul after receiving complaints from Eli Lilly, whose blood thinner drug prasugrel was up for consideration. Lilly alleged Kaul had an “intellectual conflict of interest” because he had published several abstracts at a scientific meeting criticizing the drug (see this GoozNews post).

In response to Hinchey’s request for information on other cases in which advisory committee members were excluded for intellectual conflicts of interest, Mason said it occurs “very infrequently,” identifying only two “relevant situations over the past five years,” according to FDAWebview (subscription required).

“The fact that cases of intellectual bias occur so infrequently makes it even more alarming that FDA staff would take such bold action without consulting senior agency officials,” Hinchey said. “FDA is broken and is in need of comprehensive reform that will break the inappropriately close ties between the agency and the drug manufacturers it is supposed to regulate.”