Only three months after it had been set up, the Food and Drug Administration’s (FDA) Tobacco Products Scientific Advisory Committee was already dealing with a complaint against two of its members.
In early June 2010, an ethics watchdog group, called Citizens for Responsibility and Ethics in Washington, filed a complaint with the inspector general of the Department of Health and Human Services (DHHS), saying that Dr Neal Benowitz and Jack Henningfield should be disqualified because they are consultants for drug companies that make smoking cessation products.
Jack E. Henningfield is an addiction expert; he holds a share of a patent in a nicotine gum product under development and is a vice president at Pinney Associates, a Bethesda, Md, consulting firm for drug companies, including GlaxoSmithKline.
Dr Neal L. Benowitz, a professor of medicine at the University of California, San Francisco, is a drug industry consultant on treatments to help people stop smoking. Dr Benowitz said he did not see any conflict. Altria Group, the owner of Philip Morris USA, had objected to the same panellists in March, but the FDA rejected that challenge on the grounds that tobacco-cessation drugs were not part of the Center for Tobacco Products’ regulatory purview.
One day after the ethnics group had filed its complaint, a group of ten US public health advocates, lead by Michael Siegel and Alan Blum, also made its discontent with the TPSAC public.
The group, which calls itself the FDA Tobacco Products Scientific Advisory Shadow Panel, announced the formation of an alternative scientific panel on tobacco control aimed at, as it claims, producing more effective ways to reduce the health and economic impact of smoking than the FDA’s scientific advisory panel on tobacco.
“As in parliamentary democracies when the political party that did not prevail in the last election announces a shadow cabinet, the shadow scientific panel on tobacco represents the loyal opposition,” said Alan Blum, MD, director of the University of Alabama Center for the Study of Tobacco and Society and the panel’s co-chair.
“Although the shadow panelists may well agree with the FDA panelists on a variety of issues – we are, after all, united in attempting to reduce demand for tobacco –, in this instance the loophole-laden FDA bill, its championing by top tobacco manufacturer Philip Morris, the presence of cigarette company representatives on the panel, the initial direction of the new FDA office on tobacco, and the dominant role played by the professional FDA bureaucracy warrants an alternative, uncensored viewpoint on the direction the nation should be taking in regard to tobacco policy.”
“The FDA shadow panel will issue periodic recommendations for tobacco policy, mirroring the Tobacco Products Scientific Advisory Committee’s agenda and actions, but providing an alternative perspective that is evidence-based and free from political, corporate, or economic influence,” said Michael Siegel, MD, MPH, Professor of Community Health Sciences at the Boston University School of Public Health and co-chair of the FDA shadow panel.
The shadow panel goes on to state that, unlike the official FDA committee, it has only one member (Blum) that has “received honoraria from pharmaceutical companies for presenting a handful of talks to medical audiences on smoking”. Neither are there tobacco industry representatives or committee members who have taken tobacco money in the past or who are either pharmaceutical consultants or have taken money from pharmaceutical companies on board the shadow panel, it says.
A look at the shadow panel’s recently launched website, www.fdashadowpanel.com, which will be open for public comment and debate, shows the direction towards which the public health advocates are heading: they question, for instance, the FDA’s aggressive opposition to the electronic cigarette, while regular, “lethal” cigarettes remain on the market unchallenged; they consider the potential development of a less hazardous cigarette as another “fraud committed by the tobacco industry” (and that could neither be achieved by the FDA by regulating specific ingredients in cigarettes), and they recommend that the FDA devote all resources of its Center for Tobacco Products to “an aggressive, hard-hitting, anti-smoking campaign directed at preventing youth smoking and encouraging adult smoking cessation” and to increase cigarette prices.
They also argue that menthol should be banned, want the FDA to bar tobacco companies from funding university-based research, and would like to see the FDA issue and publicise "a major statement informing the public that filtered cigarettes, now consumed by more than 95 per cent of all smokers in the false belief that they are safe, do not confer any reduction of health risk whatsoever and represent consumer fraud" .
TJI report
See also interview with Michael Siegel, professor of community health sciences, Boston University School of Public Health. |
