Monday, July 24, 2006

Commentary by Rest of the Story Author in The Lancet Questions Anti-Smoking Groups for Supporting Philip Morris' FDA Tobacco Legislation

A commentary in this week's issue of The Lancet, written by Michael Siegel and Dr. Alan Blum (Director, University of Alabama Center for the Study of Tobacco and Society), questions the wisdom of anti-smoking groups lobbying for legislation, supported by Philip Morris, that would give the Food and Drug Administration (FDA) limited jurisdiction over the regulation of tobacco products (see: Siegel M, Blum A. FDA regulation of tobacco: reprieve for the Marlboro man? The Lancet 2006; 368:266-268).

The commentary suggests that the very fact this legislation is supported by Philip Morris should cause anti-smoking groups to be skeptical about whether it can really be the case that this bill would protect the public's health at the expense of tobacco industry profits. Our premise is that given Philip Morris' support, the bill deserves tremendous scrutiny. And sure enough, upon a careful analysis of the fine points of the bill, it becomes apparent that the legislation contains a large number of loopholes, inserted specifically to appease Philip Morris and protect its profits, that compromise the ability of the legislation to protect the public's health.

Foremost among these loopholes is a provision that essentially gives Congress veto power over any major regulations that FDA might promulgate. Congress would have 60 days to overturn, based solely on political grounds, most major FDA tobacco regulations. This ensures that the most important decisions made regarding the regulation of tobacco are made not based on scientific and policy concerns, but based on political ones. It ensures that the tobacco companies retain their ability to use their strong influence in Congress to block any meaningful regulatory action that could truly make a difference in protecting the public's health.

We also point out a number of other loopholes and absurdities in the legislation. For example: "the bill bans the use of strawberry, grape, chocolate, or similar flavouring additives in cigarettes but does not require the FDA to eliminate (or even reduce the levels of) toxic gases, including hydrogen cyanide or the more than 40 known cancer-causing constituents of cigarette smoke such as benz(a)pyrene, benzene, and radioactive polonium. The Agency would be given the authority to take such action but, unlike for the flavourings, there is no mandate that the FDA do anything to regulate these toxins."

One has to question the wisdom of a regulatory approach that takes stringent action to regulate the harmless components of this product - chocolate, grape, and strawberry - but requires no action on the toxic components - like hydrogen cyanide, benzene, or radioactive polonium. Are anti-smoking groups really protecting the public's health by being able to tell them: "We have made sure that you will not be exposed to any chocolate, grape, or strawberry. Unfortunately, you still may be exposed to more than 40 carcinogens. So sorry about that."

We also point out that there is no evidence that the performance standards allowed by the bill would do anything to protect the public's health: "[while] the bill stringently regulates new cigarette products, existing products will [merely] be subject to performance standards that would allow the FDA to require reduction or elimination of certain constituents in the tobacco smoke. However, it is not known which of the many chemicals in cigarette smoke, at what levels, and in what combination, are responsible for the observed pulmonary, cardiovascular, and carcinogenic effects of tobacco products." Thus, there is no guarantee that any required changes would protect anyone, and there is even the possibility that required changes could make cigarettes more hazardous.

In response, a Campaign for Tobacco-Free Kids commentary fails to address any of the above concerns.

The Rest of the Story

What became clear to me from this experience is that trying to discuss policy issues with the Campaign for Tobacco-Free Kids is like arguing with a brick wall.

It would have been nice if the Campaign had defended its support of the legislation by refuting, or otherwise addressing any of the specific concerns outlined above. Why does the bill grant veto power to Congress? How can the bill possibly require FDA to eliminate the grape flavor from cigarettes, but not the hydrogen cyanide? What evidence is there that performance standards will actually improve the public's health, since we don't know what specific constituents and in what combination are responsible for what diseases? And what is the public health merit of tying FDA's hands in a host of other ways, each ensuring that the most important decisions regarding regulation of tobacco products will be left in the realm of politics, rather than science?

If I were responding to my own commentary, I would have dealt point-by-point with the concerns expressed by myself and Dr. Blum. I think the public, and especially the tobacco control community, deserves an explanation as to why each of these specific concerns is unfounded. I think the Campaign, if it is going to put itself into the position of the representative of the public health community on this legislation (which I believe it has), has a responsibility to discuss and respond to these criticisms of the legislation.

Without a healthy discussion in the tobacco control and public health communities, I do not think that the Campaign has any business representing my (and our) interests in the halls of Congress.

And this response demonstrates that the Campaign is, in fact, about as responsive as a brick wall.

Apparently, the Campaign is unwilling to actually discuss the specific provisions of the legislation. Why?

Here is a hypothesis:

Maybe it's because they know that they can't win an argument over these specific provisions. Maybe they realize that these provisions are examples of compromises that were inserted in the bill specifically to protect the financial interests of Philip Morris at the expense of the public's health. Maybe it's because they realize that if they reveal the truth - that this bill resulted from a negotiation between Philip Morris and the Campaign - as the two primary interests represented at the negotiating table, the cat will be let out of the bag and it will become apparent that the Campaign has misled the entire tobacco control community, public health community, and the public. Maybe it's because it will become clear to us all that there is not, in fact, a public health justification for these provisions in the bill, and that essentially this legislation represents a behind-the-scenes, closed-door deal between the Campaign for Tobacco-Free Kids and Philip Morris that is not subject to real discussion, criticism, and revision.

Maybe, when it really comes down to it, it's because the public may become aware that the Campaign for Tobacco-Free Kids is really protecting the interests of Philip Morris at the expense of the public's health, helping to ensure that the nation's leading tobacco company receives special protections that no other manufacturer of a product regulated by the FDA enjoys (at least not in a way that is written into the law).

Perhaps because if the truth comes out, the public may realize that this organization might better be known as the Campaign for Tobacco Special Protections and Chocolate-Free Kids. After all, the bill does a fine job of keeping chocolate out of the tobacco smoke inhaled by children, but this wonderful public health gain comes at the expense of writing into law forever special protections for Big Tobacco stronger than anything Philip Morris could ever dream was possible.

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