FDA Needs a Stronger Conflict-of-Interest Policy

The FDA, already under fire in the wake of widespread food- and drug-contamination problems, is now facing criticism for its failure to adequately guard against conflicts of interest in its assessment of the safety of bisphenol A.

FDA’s draft assessment of the chemical’s safety placed more weight on industry science – Sarah Vogel critiques the agency’s approach here – and upheld the current safety standard for human exposure to the BPA in food. Now a bisphenol A subcommittee is about to advise the agency on whether to accept or amend that draft assessment, and it turns out that its chair has a potential conflict of interest – and the FDA apparently wasn’t even aware of it.

Susanne Rust and Meg Kissinger of the Milwaukee Journal Sentinel uncovered the problem:

A retired medical supply manufacturer who considers bisphenol A to be “perfectly safe” gave $5 million to the research center of Martin Philbert, chairman of the Food and Drug Administration panel about to make a pivotal ruling on the chemical’s safety.

Philbert did not disclose the donation, which is nearly 25 times larger than the $210,000 annual budget of the University of Michigan Risk Science Center, where he is founder and co-director. FDA officials learned of the link from the Journal Sentinel.

Donor Charles Gelman, once labeled the second worst polluter in Michigan by the state’s Department of Natural Resources, said in an interview that he considered the chemical, which is used to make baby bottles and aluminum can liners, to be safe. Worries about health problems that may be caused by the chemical are exaggerated by “mothers’ groups and others who don’t know the science,” Gelman said.

The Washington Post picked up the Journal Sentinel story, and the Post and the New York Times both ran editorials condemning the agency’s inadequate response. Philbert defended himself in Monday’s Journal Sentinel, stating that Gelman’s gift does not benefit him directly in any way and that the UM Risk Science Center does not accept gifts provided in an attempt to influence its work. He accused the paper of publishing articles that “stoke the fires of sensationalism and create an atmosphere that makes it difficult for the public to trust the scientific integrity of science review panels such as ours.”

Philbert did err in not reporting the $5 million gift to the FDA. When it comes to the question of whether or not his work is influenced by that donation, we have no reason to think that it has been. That’s not the important issue here, though.

The problem is that the FDA isn’t doing enough to guard against conflicts of interest – and that, rather than investigative news stories, is what imperils public trust in the agency’s work.

FDA is actually taking steps to improve transparency and reduce conflicts of interest on its advisory committees, but it still has a way to go. Philbert told the Washington Post that the FDA disclosure form requested information on gifts from which the recipient personally stands to gain. Personally, I would think that the director of a center benefits from a $5 million gift to that center, even if it’s not specifically funding his research or salary, but Philbert evidently interprets that question differently. FDA could reduce such differing interpretations by asking specifically about financial relationships of the individual’s center or department – or, as the World Health Organization puts it, “the administrative unit with which the expert has an employment relationship.”

The WHO can provide a useful model for FDA to follow. The WHO’s International Agency for Research on Cancer publishes monographs that evaluate carcinogenic risks to humans from a range of substances, and has successfully implemented the WHO’s strict policy against conflicts of interest. IARC authors describe the policy and their implementation of it in an Environmental Health Perspectives article (emphasis added):

Each potential participant is asked to declare, in confidence,

any interests that could constitute a real, potential or apparent conflict of interest, with respect to his/her involvement in the meeting or work, between a) commercial entities and the participant personally, and b) commercial entities and the administrative unit with which the participant has an employment relationship.

The WHO defines conflict of interest to mean “the expert or his/her partner, or the administrative unit with which the expert has an employment relationship, has a financial or other interest that could unduly influence the expert’s position with respect to the subjectmatter being considered.” An apparent conflict of interest exists when “an interest would not necessarily influence the expert but could result in the expert’s objectivity being questioned by others” (WHO 2004).

Experts with either real or apparent conflicts of interest can serve as “invited experts” and share their knowledge with their colleagues in discussions, but they do not participate in actually writing the IARC evaluations.

If FDA had this kind of policy, it would have been clear to Philbert that he needed to disclose the $5 million to the center, and clear to the agency that he could not serve in his present role. This would not constitute a judgment that Philbert is influenced by Gelman’s gift; rather, it would be part of a policy against an apparent conflict that could “result in the expert’s objectivity being questioned by others.”

FDA’s reputation has been eroding for the past several years. It could regain some credibility by strengthening its conflict-of-interest policy.

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