Group Says Members of FDA Tobacco Panel have Conflicts

In response to two recent appointments made by the U.S. Food and Drug Administration (FDA) to the Tobacco Products Scientific Advisory Committee (TPSAC), Citizens for Responsibility and Ethics in Washington (CREW) contacted the Department of Health and Human Services’ (HHS) Inspector General. EarthTimes said that CREW is asking the HHS to implement a probe into the appointments, citing conflict of issue problems.

Drs. Neal Benowitz and Jack Henningfield, according to CREW, both come to the appointments with alleged financial conflicts of interest due to their ties to pharmaceutical companies that manufacture smoking cessation products, said EarthTimes. CREW Executive Director Melanie Sloan said, “TPSAC panel members are barred from having financial ties to cigarette companies. Common sense dictates they shouldn’t have ties to pharmaceutical companies that make smoking cessation products either. The public needs to have confidence that new regulations are aimed at preventing smoking, not increasing drug companies’ profits,” quoted EarthTimes.

Dr. Benowitz is a paid consultant for pharmaceutical companies—Pfizer, GlaxoSmithKline, Novartis, and Aradigm, to name some—and has helped with the “design, development, and marketing of smoking cessation products,” and served as a plaintiff-side paid expert witness in tobacco lawsuits, said EarthTimes. Dr. Benowitz charged $275-$600 per hour for his expert testimony, added EarthTimes.

Dr. Henningfield, working through his firm Pinney and Associates, is also a paid consultant and works for pharmaceutical companies looking to seek approval for smoking cessation products, reported EarthTimes. Dr. Henningfield is a partner at a company that holds one—potentially others—patent for a nicotine gum and has also been a paid plaintiff-side expert witness in tobacco cases, noted EarthTimes.

According to EarthTimes, this is not the first time the FDA has allowed those with a conflict of interest on a panel, citing a 2006 incident in which then-FDA Chairman Lester Crawford pleaded guilty to such conflicts following revelations he owned stock in Pepsico and Sysco when he chaired the FDA’s Obesity Working Group. The Group made recommendations that affected manufacturers of food and soft drinks, said EarthTimes.

In 2008 the agency issued transparency and public disclosure policies for advisory committees, such as a mandate that committee members be screened for potential financial conflicts, wrote EarthTimes. Unless a waiver exists, such members are not permitted to participate in matters in which they have a financial interest, such as “stock holdings and contracts with companies … affected by the committee’s recommendations,” said EarthTimes.

Financial ties in communities tied to the medical sector can run deep and such ties have led to intense criticism and rancor. For instance, many believe such conflicted relationships could unduly influence everything from research findings to prescribing practices; the drug industry has been criticized for its ties to the medical community; and the medical profession has taken hits for accepting hi-end perks that critics feel better enable Big Pharma to gain support from prescribing doctors.

“Loathing tobacco companies does not justify ignoring clear conflicts of interest. As great as it is that the FDA is finally regulating tobacco products—and as credentialed as Drs. Benowitz and Henningfield may be—there is no excuse for including those paid to consult or create smoking cessation products on the panel…. How can we have faith in the TPSAC’s conclusions when some of its members have a vested financial interest in the panel’s decisions?” said Sloan, quoted EarthTimes.

The CREW letter can be accessed here.