Monday, June 07, 2010

Why FDA Regulation of Tobacco Constituents Makes No Sense, and Will Transfer Fraudulent Deception of Consumers from Tobacco Industry to Government

A number of health groups - such as the Campaign for Tobacco-Free Kids - contend that the new FDA tobacco law will save lives by allowing the FDA to mandate reductions in certain constituents of tobacco smoke. In fact, the basic regulatory structure of the Family Smoking Prevention and Tobacco Control Act is the task - given to the FDA - of requiring safer cigarettes by mandating the reduction or elimination of certain chemicals in cigarette smoke.

While that might sound beneficial for the public's health at first glance, a more careful analysis of the science reveals that the idea is actually an absurd one that makes no sense and will - rather than protect public health - simply transfer the fraudulent deception of American consumers from the tobacco industry over to the federal government.

The Rest of the Story

The FDA's regulatory approach to tobacco products is hampered by three critical, but often unrecognized facts:

1. We currently have no idea what constituents in cigarette smoke, at what levels and combinations, result in the observed health effects of smoking.

Without knowing the specific constituents that are responsible for the harmful effects of smoking, there is simply no way that the FDA can produce a cigarette that it knows will be safer.

2. We have only identified 4,000 of what may be as many as 100,000 chemicals in cigarette smoke. Thus, there are as many as 96,000 unknown chemicals.

With 96,000 unknown chemicals in tobacco smoke, it is clear that we cannot determine the risk of cigarettes simply by knowing the levels of the 4,000 known chemicals.

3. Research has demonstrated that risk analysis of the known constituents in cigarette smoke explains less than 4% of observed lung cancer risk. In other words, even if all identified carcinogens were removed from cigarettes, there is no evidence that the incidence of lung cancer among smokers would be reduced.

An article published in the March 2007 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."

This is a critically important study and it has vital implications for the consideration of the FDA tobacco law. Specifically, the study demonstrates the complete folly of the 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 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.

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!

The rest of the story is that there is absolutely no evidence to support the law 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. In fact, the science shows 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.

Moreover, the only way to know whether a reduction in specific constituents would reduce the risks of smoking would be to mandate those changes and then conduct long-term epidemiologic studies. In other words, smokers would have to be used as guinea pigs. The FDA would have to set so-called "safety standards" without knowing whether those standards actually reduce the product's risk. It would take years to find out.

In the mean time, smokers would be misled into believing that by virtue of the FDA's promulgation of a "safety standard," the product has been made safer. This will certainly undermine the public's appreciation of the hazards of smoking and will cause many smokers who would otherwise have quit entirely to instead continue to smoke, thinking that the FDA-mandated changes to cigarettes have made them safer.

The end result will likely be harm to the public's health, due to an increase in smoking caused by deterrence of smoking cessation because of the perception that cigarettes are now safer. In other words, it will be the "low-tar" fiasco all over again, except now it will be the federal government perpetrating this fraud instead of the tobacco companies.

It is critically important to understand that there is no way of determining cigarette risk based solely on studying the product in the laboratory. Epidemiologic studies of the actual use of the product in the population is necessary to determine whether a change in the constituents of cigarettes will lessen their health risks.

To repeat the important conclusion of Pankow et al.: "The current inability to use toxicant-specific methods to account for the observed cancer risks of smoking carries an important implication for PREP cigarettes. Namely, all expressed and implied promises of 'reduced harm' ... of PREPs (including ostensible PREPs) must be viewed as speculative and unverified. Indeed, because does considerations for known tobacco smoke lung carcinogens account for <4% of the lung cancer risk of conventional cigarettes as they are smoked by North American populations, then lowered levels of these toxicants in PREPs still leave PREPs in the possible position of being as harmful as conventional cigarettes."

This means that the FDA has been put in the absurd position of being asked to promulgate "tobacco product safety standards" for which it will have no way of knowing whether they will improve, have no effect on, or harm human health. This is an untenable to position to be in, and it needs to be rejected outright.

The FDA tobacco law has been enacted, but there is no requirement that the FDA adopt any "product safety standards." Instead, I recommend that the FDA take an entirely different approach, and devote all of its time and resources not to regulating the product, but to trying to decrease the demand for the product and actually make a dent in smoking rates by funding anti-smoking education and prevention programs, including media campaigns, throughout the country. Unlike product regulation, which has no science to back it up, the use of media campaigns to reduce smoking is supported by solid scientific evidence.

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 actually deceived 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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