Wednesday, March 28, 2007

New Study Concludes that Removal of All Known Carcinogens from Cigarettes Would Not Necessarily Reduce Cancer Risk; Exposes Folly of Proposed FDA Bill

An article published in the March issue of Cancer Epidemiology, Biomarkers & Prevention concludes that even if all currently known and measured carcinogens in tobacco smoke were completely removed, there would be little reason to believe that there would be any observable reduction in smoking-related cancers (see: Pankow JF, Watanabe KH, Toccalino PL, Luo W, Austin DF. Calculated cancer risks for conventional and 'potentially reduced exposure product' cigarettes. Cancer Epidemiology, Biomarkers & Prevention 2007; 16:584-592).

Using data on per-cigarette smoke yields of a large number of known carcinogens and the known cancer risks posed by those carcinogens, the researchers assessed the lung cancer risk posed by regular, light, ultralight, and a number of PREP (potentially reduced exposure product) cigarettes using a mathematical model. They found that neither light, ultralight, or any available PREP was predicted to offer any substantial reduction in cancer.

Moreover, the researchers found that knowledge of the yields of all currently known lung carcinogens in cigarettes was able to account for less than 4% of the observed lung cancer risk of cigarette smoking. This inability to account for observed cancer risk means, they conclude, that even if all currently known and measured carcinogens were completely removed from cigarette smoke, there would be no reason to believe that actual human cancer risk would be decreased.

The authors conclude: "The current inability to account for the observed health risks of smoking based on existing data indicates that current expressed/implied marketing promises of reduced harm from PREPs are unverified: there is little reason to be confident that total removal of the currently measured human lung carcinogens would reduce the incidence of lung cancer among smokers by any noticeable amount."

"Expressed another way, even if a PREP design were to succeed in removing all currently measured known human lung carcinogens from cigarette smoke (and even perhaps all other currently measured carcinogens), there would be little reason to be confident that such removal would by itself lead to any observable reduction in smoking related lung cancer."

In perhaps easier to understand terms, Dr. Pankow summarized his key conclusion as follows: "Since we can't account for the risks from smoking conventional cigarettes, it does not accomplish much to just remove a few of the known toxins. An analogy might be someone who abuses alcohol by drinking 10 beers a day, but says they are going to cut down to 9."

And Dr. Pamela Clark, a senior research scientist at the Battelle Centers for Public Health Research and Evaluation, explained that "Dr. Pankow's study shows that simply lowering the levels of a few known harmful compounds from tobacco smoke may not significantly reduce the risks of smoking."

The Rest of the Story

This is a critically important study and it has vital implications for the consideration of the proposed FDA tobacco legislation. Specifically, the study demonstrates the complete folly of the proposed regulatory approach and the ridiculous nature of the claims being made by the Campaign for Tobacco-Free Kids, American Medical Association, and other organizations that the legislation is going to "save countless lives."

Quite the opposite. This research demonstrates that a regulatory approach based on asking the FDA to require the reduction or elimination of various constituents of cigarette smoke is an absurd approach that offers no known or expected health benefits. Any claim that this legislation is going to save lives by requiring safer cigarettes is completely undocumented and unsupported.

As the research shows, there is no reason to believe that requiring the reduction or elimination of even a large number of the known harmful and carcinogenic constituents in tobacco smoke would result in any reduction in the risks of smoking.

In some ways, I find that the health groups are making claims that are more baseless and deceptive than anything the tobacco companies have stated about the risks of low-yield cigarette products. The cigarette companies have certainly deceived the public by implying that low-yield products offer a health advantage over conventional products. But they have never gone so far as to claim that they would save countless lives - a claim being made about the FDA legislation by the Campaign for Tobacco-Free Kids. Nor have they pinned a specific number on the lives saved, something the American Medical Association has done by suggesting that the FDA legislation will save millions of lives.

I don't really understand why it is that if the tobacco companies make such baseless, undocumented, and deceptive claims, it represents fraud and engenders attacks on the companies for their unscrupulous actions, but when we as anti-smoking groups make even more baseless, undocumented, and deceptive claims, it is now magically acceptable because we are working towards an allegedly noble cause.

I am quite sure that this new research is going to cause the Senate Health, Education, Labor, and Pensions (HELP) Committee to take serious pause before rushing forward with what now has been documented to be a flawed regulatory approach that is going to deceive the public into believing that cigarettes are safer.

As I've argued before, the FDA tobacco legislation is really a mechanism to transfer the deception about low-yield cigarettes from the tobacco companies to the government. It takes the tobacco companies off the hook, allowing them to smile all the way to the bank as the very low-yield health claims they have been found guilty of making are now made by the federal government. And to boot, the companies no longer will have to face a liability risk for making such undocumented claims. The government is going to be doing all the dirty work for them. What a brilliant scheme!

As I argued in the statement I submitted to the Senate HELP Committee, we simply do not know what constituents in tobacco smoke, and in what combination and quantities, are responsible for the observed human diseases caused by cigarette smoking. Thus, there is absolutely no evidence to support the bill supporters' contention that by reducing or eliminating specific constituents of the smoke, we will produce a safer cigarette that will save countless lives, millions of lives, or even any lives.

When I submitted that statement, this research was not yet available, but it appears to back up my argument. In fact, it goes further than I did, because it concludes that even if every known carcinogen in cigarettes were removed, we'd be in no position to be confident that the actual cancer risk of smoking had been reduced. And you can be sure that the FDA is not going to enact regulations that require the removal of every known carcinogen from cigarettes!

Realistically, the best the FDA could do under the proposed legislation would be to require the reduction or elimination of a number of specific tobacco smoke constituents. This research demonstrates that there is no basis to believe that such an approach would result in a measurable decline in smoking-related mortality.

While I acknowledge the right of supporters of this legislation to promote its passage in the absence of actual scientific research that would justify the regulatory approach taken by the bill, I do not believe that the supporters of the bill have any right to misrepresent the science and to deceive policy makers and the public into thinking that the bill is surely going to save millions of lives when there is no basis for confidently knowing that this is going to be the case. In fact, there is strong evidence that any such contention is baseless and unsupportable.

In contrast, there is strong reason to believe that while the bill would do little to protect the public's health by ensuring that cigarettes are made to be a safer product, it would do great harm by giving the public the impression that cigarettes are safer by virtue of FDA regulation and an FDA stamp of approval for the product.

The rest of the story is that in their zeal to put a feather in their cap by being able to claim that they achieved FDA regulation of tobacco products, the major anti-smoking and health groups are actually deceiving the public about the potential health benefits of lower-yield cigarettes to a greater degree than anything the tobacco companies have ever done.

Frankly, the tobacco companies wouldn't even dream of deceiving the public to this extent. They remained somewhat subtle in their deception, by merely implying that there is some health value to reduced yield cigarettes. I can only imagine the scorn and ridicule the companies would have received had they claimed that their lower-yield cigarettes were going to save countless lives.

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