Conflict of Interest Regulations Apply Symmetrically

Last week, a federal judge ruled that working as a plaintiffs’ expert witness in tobacco litigation or as consultants for pharmaceutical companies with tobacco-cessation medications was a conflict of interest, which invalidated a FDA report on menthol cigarettes. Lorillard Inc. et al. v. U.S. Food and Drug Administration, 1:11-cv-00440, D.D.C. (July 21, 2014).

The report was issued in 2011 by the agency’s Tobacco Products Scientific Advisory Committee (TPSAC).  Two tobacco companies sought an injunction against the FDA’s report because of the improper memberships on the TPSAC of Drs. Jonathan Samet and Neil Benowitz. Lorillard’s General Counsel also challenged agency pronouncements under the Data Quality Act.  Letter Request for Correction of Information Disseminated to the Public and the Tobacco Products Scientific Advisory Committee (March 16, 2011) (petition lodged under the Data Quality Act (DQA), 44 U.S.C. § 3516, and the related agency regulations of the Office of Management and Budget, Health and Human Services, and FDA).

Although the TPSAC report concluded that menthol cigarettes imparted no greater risk of lung cancer than the already deadly non-menthol cigarettes, the report claimed that studies show menthol flavoring increased usage among young people and African Americans.  The TPSAC recommended a ban on menthol cigarettes in the interest of public health. The district court held that the FDA’s decision that the disputed members had no conflict of interest violated the Administrative Procedures Act, and that the violation required the agency to reconstitute the TPSAC in compliance with the applicable ethics regulations.

What is remarkable about the case is its rejection of the delusion that advocacy for plaintiffs is not a potential conflict of interest, whereas advocacy for a company is.  An amicus brief filed on behalf of several medical and public health groups, including Public Citizen, Inc., American Cancer Society, American Medical Association, American Thoracic Society, and others, supported the agency’s motion to dismiss. Amici argued that balancing scientific opinions of experts on the committee would impair the integrity of advisory committees and would be unmanageable for courts. Given the obvious adversarial bias from service as an expert witness in tobacco litigation, the district court rejected amici’s arguments. Although amici’s position is understandable as a reaction to the callousness of tobacco marketing, the brief’s indifference to the ethical implications about conflicts of interest is surprising.  One can only imagine the hue and cry if there had been committee members who had been engaged as expert witnesses for the tobacco companies.

The implications of the Lorillard decision are considerable, especially for FDA advisory committees. See Glenn Lammi, “FDA Advisory Committee Not Rife with Conflicts of Interest? — ‛Please!’ Quips Federal Judge” (July 24, 2014) (discussing Lorillard case and detailing efforts to obtain FDA compliance with the Federal Advisory Committee Act). Industry representatives are typically non-voting members, but members who have been retained by the litigation industry have served in voting positions. In other contexts, expert witnesses for plaintiffs accuse scientists who testify for a defendant of “conflicts of interest,” but conveniently ignore and fail to disclose their own. SeeMore Hypocrisy Over Conflicts of Interest” (Dec. 4, 2010) (Arthur Frank, Richard Lemen, and Barry Castleman); James Coyne, “Lessons in Conflict of Interest: The Construction of the Martyrdom of David Healy and The Dilemma of Bioethics,” 5 Am. J. Bioethics W3 (2005). The Lorillard case teaches that “white hat” bias is as disqualifying as “black hat” bias.

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