Tuesday, June 08, 2010

Tobacco Experts Form FDA Shadow Panel as Alternative to Actual FDA Tobacco Products Scientific Advisory Committee

A group of ten individuals with extensive experience over four decades in fighting smoking in the U.S. has announced the formation of an alternative scientific panel on tobacco control aimed at producing more effective ways to reduce the health and economic impact of smoking than the FDA's scientific advisory panel on tobacco. The group – the FDA Tobacco Products Scientific Advisory Shadow Panel – is also unveiling its web site (www.fdashadowpanel.com).

“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." As founder of the first physicians' anti-smoking organization, Doctors Ought to Care (DOC), in 1977, Dr. Blum has been continuously involved in tobacco control for more than 30 years.

“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.

In contrast to the actual FDA Tobacco Products Scientific Advisory Committee, which includes three tobacco industry representatives, a committee member who has taken tobacco money in the past, and four committee members who are either pharmaceutical consultants or have taken money from pharmaceutical companies, one Shadow Panel member (Dr. Blum) has received honoraria from pharmaceutical companies for presenting a handful of talks to medical audiences on smoking.

The shadow panel also launched its website, www.fdashadowpanel.com, written by the panel members, each of whom has extensive experience over many years in addressing different aspects of the smoking pandemic. The website will be open for public comment and debate.

Several of the shadow panelists have been critical of the early efforts and priorities of the FDA agency on tobacco, which they see as misguided. For instance, Dr. Siegel has raised questions about the FDA's aggressive opposition to the electronic cigarette in contrast to its silence on Marlboro and other popular cigarette brands which have been recognized as lethal since the 1964 Surgeon General's report and yet remain unchallenged on the marketplace. Dr. Siegel and Dr. Blum have also pointed to conflicts of interest of panel members. The chair of the panel, Dr. Jonathan Samet, has in the past aided the tobacco industry in setting the agenda for research on secondhand smoke. Other panelists have competing interests by currently receiving pharmaceutical funding. The pharmaceutical industry stands to gain if the tobacco industry's so-called reduced harm nicotine products, such as non-combustible smokeless tobacco, are not permitted to compete with its higher-priced medications as aids in smoking cessation.

For Dr. Blum, who testified in opposition to the FDA bill at both the Senate and House of Representatives hearings, the FDA has not been granted sufficient power by Congress to seriously hamper cigarette sales. He finds it absurd that the same agency charged with regulating cancer drugs, which the FDA can pull off the market if found to have inordinate toxic side effects, now has oversight over cigarettes, which it cannot remove from the market. “Congress could have banned menthol in the bill, for instance,” notes Blum, “as it was pressured to do by former Health and Human Services Secretary Dr. Louis Sullivan and numerous African-American leaders and organizations who accuse cigarette manufacturers of decades of deception in targeting menthol brands to African-Americans. But Democratic proponents of the bill kowtowed to Philip Morris in order to get the bill passed. Now the FDA has dug itself a bottomless hole by having to scratch out a scientific case against menthol argument."

On its web site, each of the Shadow Panel members has offered recommendations for what should be the FDA’s priority in regulating tobacco products. Dr. Siegel states: “I believe that it makes no sense whatsoever to ask the FDA to approve tobacco products - which kill hundreds of thousands of Americans each year - for sale in the United States. It is equally absurd to think that by regulating specific ingredients in cigarettes, the FDA will be able to produce a safer cigarette. Instead, the fraud committed by tobacco companies through their ‘safer cigarette’ myths will now be transferred over to the federal government. Regulating the product is not an evidence-based approach to the control of tobacco-related disease. In contrast, increasing cigarette prices and allocating the resources to aggressive, anti-smoking media campaigns are a scientifically proven way of reducing tobacco use. My recommendation, therefore, is for the FDA to devote all of the 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.”

Dr. Blum would like to see the FDA issue and publicize a major statement informing the public that filtered cigarettes---now consumed by more than 95% of all smokers in the false belief that they are safe---do not confer any reduction of health risk whatsoever and represent consumer fraud. "Nothing would debunk the lies of the tobacco industry better than that," he says. He would also like the FDA to bar tobacco companies from funding university-based research and claiming to be part of the solution and not the source of the problem. "The commingling of money from the tobacco industry with taxpayer-supported funding from the National Institutes of Health is obscene and needs to be stopped once and for all. It is particularly odious when the tobacco industry continues to recruit students on college campuses to become cigarette sales managers and continues to deny in court that its products cause lung cancer, emphysema, and heart disease."

Dr. Heinz Ginzel, Professor Emeritus of Pharmacology and Toxicology at the University of Arkansas for Medical Sciences, questions the entire premise of FDA regulation of tobacco products, stating “Any regulatory actions concerning tobacco taken under the auspices of the FDA are jeopardizing, contaminating, degrading and corrupting the declared original mission of the FDA. However you turn or bend it, tobacco, as much as any other potentially lethal self-exposure, simply does not fit under the regulatory scheme of the FDA.”

John Polito, the founder and director of WhyQuit.com, argues that the FDA should issue regulations requiring that tobacco products may only be sold at locations to which youth are prohibited from entering.

The complete list of members of the Shadow Panel is as follows:

Alan Blum, MD - Co-Chair
Director, Center for the Study of Tobacco and Society
University of Alabama

Heinz Ginzel, MD
Professor Emeritus of Pharmacology and Toxicology
University of Arkansas for Medical Sciences

Edward Anselm, MD
Chief Medical Officer, FidelisCare New York
Assistant Professor of Medicine, Mount Sinai School of Medicine

John R. Polito, JD
Founder and Director of WhyQuit.com
Co-Founder of Freedom from Nicotine

Eric Solberg, MS

Associate Dean, University of Texas

Health Sciences Center Graduate School

of Biomedical Sciences

Michael Siegel, MD, MPH - Co-Chair
Professor, Department of Community Health Sciences
Boston University School of Public Health

Martin Pion, BSc
Founder, Missouri GASP (Group Against Smoking Pollution) Inc.

James Repace, MSc
President, Repace Associates, Inc.

Michael S. Givel, PhD
Associate Professor of Political Science
University of Oklahoma

Anne Landman, BA
Managing Editor, Center for Media and Democracy

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