Ethics group wants FDA to drop two tobacco advisory panel members
By Julian Pecquet – 06/07/10 12:33 PM ET
The good government group Citizens for Responsibility and Ethics in Washington (CREW) wants the Food and Drug Administration to drop two members of its advisory panel on tobacco products for what it calls “clear financial conflicts of interests.”
The group says Neal Benowitz and Jack Henningfield have received money from companies that market smoking-cessation products and acted as expert witnesses paid by plaintiffs to testify against tobacco companies.
“The FDA’s failure to meaningfully consider the conflicts of interest of [the panel’s] members threatens to undermine the integrity of any recommendation [the panel] may make,” CREW Executive Director Melanie Sloan wrote Monday to Daniel Levinson, inspector general for the Department of Health and Human Services. “Worse, this failure does not stand in a vacuum; historically the FDA has done very little, if anything, to avoid conflicts of interest among those who serve on its advisory committees and scientific panels.”
FDA did not immediately respond to a request for comment.
The panel was announced in August 2009 and its 12-member roster was unveiled in March. CREW’s concerns mirror those raised in March by Altria Group Inc., parent company of Philip Morris USA and the U.S. Smokeless Tobacco Company.
The panelists’ appointment “will undermine the [Tobacco Products Scientific Advisory Committee’s] credibility, deprive the regulated industry of a fair process, and ultimately do a disservice to the public who will not obtain the benefits of a fair and impartial scientific assessment of the ongoing issues,” Altria Executive Vice President and General Counsel Denise Keane wrote on March 22 to FDA Commissioner Margaret Hamburg.
Altria also raised questions about two other panelists: Gregory Connolly and Jonathan Samet, the panel’s chair.
Lawrence Deyton, the director of FDA’s Center for Tobacco Products, told Altria that “prospective voting members were required to assure the agency that they had not received any salary, grants, payment or support from the tobacco industry in the preceding 18 months.”
CREW says that response ignores concerns raised about payments received as expert witnesses and from work on smoking-cessation products.
Specifically, the CREW letter requests that FDA investigate whether its concerns constitute conflicts of interest that justify removing the panelists; whether FDA followed policy in naming them initially; and whether appropriate action was taken after Altria first raised concerns. If FDA rules weren’t violated, the letter says, the agency should recommend changes to prevent such conflicts in the future.
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