Tuesday, December 6, 2011

FDA disqualifies advisory committee member due to "intellectual conflict of interest"/ NJ.com

Sidney Wolfe, MD, is a well-known drug safety advocate and founder/ director of the organization Public Citizen's Health Research Group.  FDA finally blessed the quality of his work and reputation by inviting him to join its Drug Safety and Risk Management Advisory Committee in 2008.

But suddenly FDA has disqualified him from full voting membership at the committee meeting on the drug YAZ due to a claimed intellectual conflict of interest.  Let's look first at the basis of FDA's claim, and then look into what is generally considered a conflict of interest.

According to the Newark Star-Ledger, Public Citizen gave a "Worst Pills" rating to Yasmin, the predecessor to YAZ oral contraceptive, now the leading contraceptive pill by sales in the US:
The FDA said it disqualified Wolfe, the director of Public Citizen’s Health Research Group, from the meeting on the contraceptives for his "intellectual conflict of interest.’’
The agency recently learned that Public Citizen, a non-profit consumer advocacy organization, had placed one of the contraceptives, Bayer’s Yasmine — a predecessor to Yaz — on its list of "Do Not Use Pills’’ in 2002.
"He did not volunteer this information,’’ said agency spokeswoman Erica Jefferson. "It was brought to our attention.’’
The FDA offered Wolfe two options: He could present information to the advisory committee like other members of the public or he could sit on the committee, participate in the discussion but refrain from voting.
Wolfe declined both options.
Advisory committee members, she said, are asked by the agency to disclose such information. "We do value Dr. Wolfe’s contributions,’’ Jefferson said, "but we are committed to preserving the integrity of the committee process.’’
 The Public Citizen website appears to give YAZ a balanced report.

What precisely is the meaning of "conflict of interest"?  According to the Columbia University course "Responsible Conduct of Research" syllabus:
There are many varieties of conflicts of interest, and they appear in different settings and across all disciplines. While conflicts of interest apply to a "wide range of behaviors and circumstances," they all involve the use of a person's authority for personal and/or financial gain.2

2.  Bradley SG. Managing Conflicting Interests, p. 136. In: Magrina FL, editor. Scientific Integrity: An Introductory Text with Cases. Washington, DC: American Society for Microbiology; 2000, pp. 131-157.

According to this definition, because Sid Wolfe did not stand to gain from either the presence of YAZ and Yasmine on a Public Citizen website, nor from his presence on the committee as a voting member,
he had no conflict of interest and therefore had no obligation to disclose to FDA what was on the Public Citizen website (or anything else).

FDA is plagued by many members of its advisory committees having financial conflicts of interest, which are not always disclosed.  Sometimes 50% of members have such conflicts, for which waivers are routinely granted.

Yet here comes physician Sid Wolfe, whose clear, career-long interest is in making the US pharmacopiea safer, and who may have preexisting knowledge about the drug in question.  Shouldn't FDA encourage members with more knowledge of a specific drug to participate in discussions about that drug?

Yet FDA finds this an intellectual conflict of interest.  I recall the CDC advisory committee that voted to expand the indications for anthrax vaccine.  None of them were experts on the vaccine... and this meant they were easily led by factual omissions and spin in the way information was presented to the committee by CDC staffers.  No one had the knowledge to detect the spin.

I just discovered that Ed Silverman at Pharmalot is blogging about this subject, so please go to his site for more information, including a pending inquiry to FDA.  Note also that Janet Woodcock of CDER is the person who pulled the plug on Wolfe in this case... and she is someone not known for her integrity in the relicensure of Lotronex.  Public Citizen also discusses Lotronex and Woodcock on its website.

No comments: