http://www.medpagetoday.com/Washington-Watch/FDAGeneral/50357
Four members ousted from agency’s tobacco advisory committee.
by Shannon Firth
WASHINGTON — Four members of its Tobacco Products Scientific Advisory Committee (TPSAC) were dismissed or have resigned, the FDA said, following a federal court decision last year that they were too cozy with anti-tobacco interests.
Three new members have already been chosen for the committee, according to an FDA press statement.
The shake-up follows a July 2014 ruling by U.S. District Judge Richard Leon, who ordered the agency to overhaul the committee, as well as prohibiting use of its 2011 report that found menthol as a cigarette additive is harmful.
Leon’s decision came in a lawsuit filed in 2011 by tobacco manufacturer Lorillard. The firm argued, and Leon agreed, that some members of the committee had unacceptable conflicts of interest because of their relationships with companies that make tobacco-cessation products and/or were working with litigants in anti-tobacco lawsuits.
Leon ruled that the members’ conflicts “irrevocably tainted [the committee’s] very composition and its work product.”
The four departing members are: Chairman Jonathan Samet, MD, MS, director of the University of Southern California Institute for Global Health; or Medical Sciences; Joanna Cohen, PhD, professor at John Hopkins School of Public Health; and Suchitra Krishnan-Sarin, PhD, associate professor of psychiatry at the Yale School of Medicine.
“This is a loss for the FDA and for public health. Under other circumstances, there would be strong reasons for the agency to consider a waiver or authorization that would allow these individuals to continue their valuable service. However, in light of Judge Leon’s ruling, we do not believe we are able to exercise our discretion to consider this option at this time,” wrote Mitch Zeller, JD, director of the Center for Tobacco Products.
Any candidate for an FDA advisory committee must relay his or her financial holdings, employment, and research grants and contracts, for the agency to assess potential conflicts of interest. “All original and current TPSAC members successfully met the FDA’s rigorous requirements upon selection,” wrote Zeller. “However, Judge Leon’s ruling further expands the FDA’s [conflict of interest] criteria.”
The new court ruling mandated “rescreening” four members of the committee who failed to meet Judge Leon’s criteria. Afterwards these four members either resigned or were terminated.
Their replacements so far include Pebbles Fagan, PhD, MPH, associate professor at the University of Hawaii Cancer Center; Gary Giovino, PhD, professor and chair of the department of community health and health behavior at the University of Buffalo; and Thomas Novotny, MD, MPH, professor and associate director for border and global health at San Diego State University Graduate School of Public Health.
Rosamond Rhodes, PhD, professor of medical education and director of bioethics education at the Icahn School of Medicine at Mount Sinai, in New York City, said that conflicts of interests have been demonstrated in multiple studies and are common in research fields.
“In medical centers, in places that have allowed drug representatives to provide pizza lunches or give out pens, the prescribing patterns are very different from institutions that don’t allow it,” Rhodes said.
And the psychological effects are “invisible” to the person who’s experiencing them.
But the people with expertise tend to be people with conflicts of interests, she said.
“The danger moving forward is if you keep making the conflicts of interest standards higher, you keep decreasing the pool of expertise that’s available to serve on these important committees. So you’re risking the scientific rigor on the one hand. On the other hand you’re risking biased judgment,” Rhodes said.
“The leadership of FDA tends to be, in my limited experience, very in tune to what the expertise needs are. So I’d be worried that perhaps this change has gone too far.”
Leon is the same judge who, in 2012, threw out an FDA requirement that cigarette packaging include graphic images of diseased lungs and other adverse impacts of smoking, and who prevented the FDA in 2009 from banning imports of e-cigarette devices as unapproved drug-delivery devices.