Thursday, May 07, 2009

The Lessons from History: Scientists Ideas About How to Make Safer Cigarettes Can Severely Backfire

In 1974, the National Cancer Advisory Board - an advisory committee of the National Cancer Institute - made a detailed set of recommendations regarding the regulation of cigarettes. The recommendations called for federal regulation of the tar and nicotine deliveries of cigarettes, which would be administered by a federal agency. The agency would require that cigarette companies gradually reduce the tar and nicotine levels of cigarettes from the 1973 averages of 19.2 mg tar and 1.3 mg nicotine.

Moreover, the agency would seek technical advice from the National Heart and Lung Institute regarding the maximum emissions of various smoke constituents. In addition, an appeal would be made to cigarette companies to preferentially market low tar and low nicotine cigarettes.

Here are the recommendations put forward by the National Cancer Advisory Board:

"1. A Government agency should be empowered to set maximum cigarette levels of tar and nicotine that will become progressively lower than the 1973 averages of 19.2 milligrams and 1.3 milligrams respectively. Such decreases should be undertaken slowly enough to insure that no important increase in the number of cigarettes consumed does occur. These actions should insure that a range of cigarettes including some with very low tar and nicotine contents continue to be available."

"2. Since smoking has a severe impact on cardiovascular and respiratory diseases, the Government agency empowered to regulate maximum emission of undesirable smoke components should get appropriate technical advice from the National Heart and Lung Institute."

"3. Pending the accomplishment of the foregoing recommendations through changes in the existing law, the President of the United States might consider making a public personal appeal to the tobacco and cigarette industry for voluntary and rapid efforts towards preferential marketing of low tar and low nicotine cigarettes, and towards reduction of other smoke components that may be recognized as hazardous."

The Rest of the Story

As the research that was released through the New York Times on Tuesday reveals, the approach recommended by the National Cancer Advisory Board was an utter disaster. The sharp reductions in tar and nicotine yields that the cigarette companies ended up implementing voluntarily did not reduce disease rates and there is evidence that this approach might have actually increased lung cancer risk by inducing smokers to inhale more deeply, resulting in the delivery of smoke constituents to the more susceptible periphery of the lung.

Interestingly, at the same time that it made its recommendations, the National Cancer Advisory Board warned that the recommendation might turn out not to work. Right after its recommendations, the Board quietly stated: "The public must be informed that there is currently no known formula for a safe cigarette, and that the restrictions here suggested are likely to produce, but cannot guarantee a reduction of hazards from smoking." Of course, that didn't stop the Board from going ahead and issuing the recommendation anyway.

Before I get to the main implication of this story, I should note that it is interesting that anti-tobacco lawyers are suing the cigarette companies for following precisely the recommendations set out by the National Cancer Advisory Board. If I were a tobacco company defending such lawsuits, I would cite this 1974 document and assert that my company was merely trying to voluntarily follow the recommendations of the prestigious National Cancer Institute: "Rather than waiting for the federal regulations that were recommended by the Institute, we decided to be a good corporate citizen and to voluntarily implement these recommendations. It is a shame that we are now being sued for having taken these government recommendations seriously."

The primary implication of this story is that the cigarette and the act of smoking are incredibly complex phenomena, and it is far too simplistic to believe that by requiring a particular change in cigarette design or smoke constituents we will be able to predictably and reliably produce reductions in actual human disease risk.

The FDA tobacco legislation will put the FDA in precisely the same position as the National Cancer Advisory Board was in 1974. The FDA will have many ideas about how to produce a safer cigarette. Scientists like Dr. Burns will come forward and claim that they have the solution to the problem: simply change the way the tobacco is cured, or simply do this or do that.

But without being able to test these changes in clinical studies, we will actually have no idea what the effect of these changes will be. While there will be no evidence that these changes will actually produce a safer cigarette, smokers will believe that cigarettes have been made safer by virtue of the FDA regulation of the product and by virtue of the FDA's adoption of product "safety standards."

In essence, the government will be in the position that the tobacco companies were in when they marketed low-tar and low-nicotine cigarettes: the government will be fraudulently deceiving the public into believing that cigarettes are safer but without actual evidence that, as actually used by human consumers, the product will demonstrably reduce the overall risk of disease.

Thus, the FDA legislation will simply transfer the fraud that the cigarette companies were accused of committing over to the federal government. Now, instead of the tobacco companies deceiving the public and making false assurances, the federal government will be taking over that role.

I am not arguing here that a safer cigarette is not possible. I am just arguing that at the present time, we don't have any idea of how to produce it. Moreover, it is not the federal government who is in the best position to design a safer cigarette. It is the cigarette companies, who have the ability to research, test, and develop new products.

The problem with the FDA legislation is that it takes away the ability of the tobacco companies to research, test, and develop new products because it removes the incentive: there is virtually no possibility of ever introducing a truly safer cigarette into the market. This is because the legislation requires companies to prove that the product is safer. To do so, a company would have to market the product for many years and conduct long-term epidemiologic studies. But to do that, the company would need the product to already be approved. So it is a complete catch-22. You can't market a reduced risk product until you prove it is safer. But you can't prove it is safer until you market it for many years. Thus, the bill puts an end to harm reduction as a tobacco control strategy and assures that in the future, the cigarettes we see will be the more dangerous conventional ones, not any truly safer ones.

George Santayana once said: "Those who do not learn from history are doomed to repeat it." Congress - and the public health groups that are supporting the FDA tobacco legislation - are now poised to repeat the unfortunate history of the low-yield cigarette scam (which I might add was a scam not just by the cigarette companies, but by public health groups and the government as well).

Perhaps the greatest lesson from this episode in tobacco control history is that we need to be a little more modest about predicting human risk from cigarette design and constituent changes. When you're dealing with tobacco combustion, you really don't know what you're dealing with until it's all said and done.

Perhaps a more relevant modern quote, then, would be the lyrics from Steve Azar's song "You Don't Know a Thing:"

"When you're young, you think you know it all,
Yeah, you're hot-rod cocky...
Well, you don't know how it'll go ...
Man, you don't know a thing."

(Thanks to Rose for the tip).

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