FDA Tobacco Advisory Committee: 6 Jokers In A Stacked Deck

Bad hand dealt to consumers

The ostensible point of the FDA’s new congressionally-granted powers to regulate tobacco was to responsibly oversee the manufacture, marketing and distribution of tobacco in the name of harm reduction.

But instead,” says Audrey Silk, founder of Citizens Lobbying Against Smoker Harassment (C.L.A.S.H.), “the panel they’ve chosen to accomplish this task seems deliberately selected to steer away from that mission toward another: promoting lucrative substitutions.  Far from being composed of objective and cleanly disinterested scientists,  the list of  participants  announced so far has been shown to be deeply biased against tobacco,  biased against smokers and neck-deep in pharmaceutical-rooted conflicts of interest.”

¶   Jonathan Samet, the Committee’s chairman, is director of the Institute for Global Tobacco Control, which is funded by Pfizer and GlaxoSmithKline, manufacturers of nicotine replacement products and quit-smoking drugs.  An
activist in the stamp-out-tobacco movement since the early 1980′s, he’s also pursued his studies through the generous funding of anti-tobacco lobby groups and GlaxoSmithKline.

Dr.  Neil Benowitz scores a trifecta– financially beholden to Pfizer, GSK, and Nabi Pharmaceuticals. Most famously, Benowitz co-authored a study whose purpose was to establish a scientific basis for the use of Pfizer’s Chantix as a quit-smoking aid; thereafter he continued to act as a paid consultant in promoting the drug’s use.  Chantix, called “the most dangerous drug in America” in 2008 by the Institute for Safe Medication Practice, has also earned a black box from the FDA as an established cause of  “serious neuropsychiatric symptoms” including  violence,  hallucinations, seizures, uncontrolled muscular spasms,  clinical depression and completed suicide. The FAA banned its use by pilots.

Dr.  Dorothy Hatsukami is a recipient of a grant from Nabi Biopharmacueticals to develop a vaccine (NicVAX) against nicotine use.  Anti-nicotine vaccines are said to get their effect by blocking the pleasure receptors in the brain.
 
Dr.  Jack Henningfield, another paid consultant for GlaxoSmithKline,  additionally owns the patent on a proprietary nicotine replacement product.

Dr. Greg Connolly, a former Director of Tobacco Control for the state of Massachusetts,  has long been among the most active and ardent of the Anti-Smoking advocates in the history of such advocacy.   In his official capacity,  and with taxpayer money, he  has denigrated,  banned and “denormalized” smokers. Further, according to Dr. Elizabeth Whelan, president of the American Council on Science and Health, “Connolly is the most extreme anti-harm reduction person I’ve ever heard of.”

¶ Most egregious where C.L.A.S.H. is concerned, Patricia Nez Henderson was chosen by FDA to “represent the public,” as though the “public” were composed of,  and only composed of,  professional anti-smokers and nonsmokers.  As a member of the board of the extremist  Americans for Nonsmokers Rights– a well-known anti-smoker group – Ms. Henderson’s perspective is hardly “representative” of the public whose interests are directly affected by the actions of this committee and the “public,” it was reasonable to assume, the FDA meant when soliciting an advocate to fill that seat.  The “public,” in this case, is the consumer.

“You’d think,” Silk comments, “they’d want to hear the smokers’ perspective and even make use of the smokers’ experience in designing their government-approved cigarette.”
 
In appraising the FDA’s choices for this panel, the Wall Street Journal understatedly opined that “the[se] selections raised questions about whether the members would have a conflict of interest on topics such as whether to approve a low-carcinogen smokeless tobacco product as a safer alternative to cigarettes.” After all, it continued, “[s]uch products compete for smokers’ dollars against smoking-cessation aids such as” [those made by many of the panelists' pharmaceutical backers.]

Dr. Michael Siegel, an anti-tobacco advocate and professor of Public Health at Boston University, added his own appraisal: “There is no way this panel can objectively consider tobacco product regulation and policy – based purely on the science – in the midst of such a potpourri of pharmaceutical financial interests and conflicts of interest.”

And Dr. Whelan summed it up: “It’s hard to imagine a more biased group.”

“A scene from Wonderland,” Silk says. “And we’re Alice when, at trial, the Red Queen declares ‘Sentence first – verdict afterwards.’ When Alice objects that that’s not a fair trial, the Queen commands, ‘Off with her head.’  Alice then pointedly asks, ‘Who cares for you? You’re nothing but a pack of cards!’ at which point the pack rose up and came flying down upon her.”

“This particular pack of cards,” says Silk, “is full of misrepresentative and hurtful jokers.  And somebody ought to care.”

 

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