The Family Smoking Prevention and Tobacco Control Act, the 2009 law that authorized the FDA to regulate tobacco products, required the appointment of an advisory committee to help the agency do so. The law specifies that no member of the Tobacco Products Scientific Advisory Committee (aside from three nonvoting industry representatives) "shall, during the member's tenure on the committee or for the 18-month period prior to becoming such a member, receive any salary, grants, or other payments or support from any business that manufactures, distributes, markets, or sells cigarettes or other tobacco products." But as Washington Examiner columnist Timothy Carney noted last month, several of the experts appointed to the committee have financial ties to pharmaceutical companies that manufacture nicotine replacement products, which compete not only with cigarettes but with various safer alternatives that the FDA is deciding how to regulate. This week Citizens for Responsibility and Ethics in Washington (CREW), a left-leaning watchdog group, asked the inspector general of the FDA's parent agency, the Department of Health and Human Services, to investigate the decision to appoint two of those panelists:
Dr. Neal Benowitz is a paid consultant for pharmaceutical companies, including Pfizer, GlaxoSmithKline, Novartis and Aradigm, assisting with the design, development and marketing of smoking cessation products. He also has served as a paid expert witness for plaintiffs suing tobacco companies, charging between $275-$600 per hour.
Dr. Jack Henningfield, through his firm, Pinney and Associates, is a paid consultant for pharmaceutical companies seeking approval of smoking cessation products. He is also a partner in a company that holds at least one patent for a nicotine gum. Like Dr. Benowitz, he also has been paid to testify for plaintiffs in tobacco cases.
CREW argues that the appointment of Benowitz, a professor of medicine at U.C.-San Francisco, and Henningfield, vice president for research and health policy at Pinney Associates, violates rules for advisory committees that the FDA adopted in 2008. "Absent a waiver," it says, "committee members cannot participate in particular matters in which they have a financial interest." CREW Executive Director Melanie Sloan elaborates:
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?
Americans for Limited Government and the American Council on Science and Health also have complained about conflicts of interest on the advisory committee, which Michael Siegel first highlighted on his tobacco policy blog in March. Benowitz claims not to understand what the fuss is about:
I really don't see any conflict. My involvement with pharmaceutical companies is aimed at reducing the risk of smoking, quitting smoking. The aim of the committee is also to reduce the adverse health consequences of tobacco use.
Seriously? Companies that manufacture or distribute cigarette substitutes that provide nicotine without smoke, such as snus, tobacco pellets, and electronic cigarettes, could say the same thing: Their aim is to "reduce the adverse health consequences of tobacco use," and make a profit doing so. How is that fundamentally different from what Novartis or GlaxoSmithKline does? The pharmaceutical companies have a lot riding on the FDA's decisions about whether to tolerate and how to regulate alternatives to their nicotine gum, lozenges, patches, and inhalers.
That doesn't mean Benowitz and Henningfield are not qualified to advise the FDA in this area. Aside from their many years of experience with tobacco issues, both are willing to acknowledge that different tobacco products pose different levels of risk, and both are at least theoretically open to the idea of tobacco harm reduction—qualities that distinguish them from many, if not most, public health officials and anti-smoking activists. Still, both seem inclined to favor the kind of regulations that would reduce competition in the market for cigarette substitutes. It would have made sense to balance them with panelists who are more sensitive to the costs of such regulations, and it is plainly irrational to let Benowitz and Henningfield serve on the committee while excluding otherwise qualified experts based on, say, research funding or consulting fees from the smokeless tobacco industry.
Nevertheless, as someone who is still accused of being a tobacco industry flack based on a reprint fee that R.J. Reynolds paid me 16 years ago, I am skeptical of the implication that people like Benowitz and Henningfield take the positions they do because of their financial ties to the pharmaceutical industry. Although strict regulation (or outright prohibition) of nonpharmaceutical cigarette alternatives clearly would benefit the drug companies, there is no need to speculate about financial motives, since tobacco control scientists (and public health academics generally) are, by and large, ideologically predisposed to favor more government intervention. In any case, motives are logically irrelevant in assessing the merits of any particular tobacco policy. Still, it's hilarious that Stanton Glantz, an anti-smoking activist who is notorious for accusing anyone who disagrees with him of secretly working for Big Tobacco, comes to Benowitz and Henningfield's defense by insisting that money doesn't matter.
In a 2007 Reason article, Ron Bailey explored "the overrated risks and underrated benefits" of "conflicts of interest" in pharmaceutical research.