Editor’s Note: Professor Siegel delivers a devastating analysis of the foundations of FDA regulatory programs to reduce risk from tobacco use. Professor Siegel delivered an equally scathing analysis of a Surgeon General’s report in 2006.
Hopefully, FDA is cognizant of the tendency of certain stakeholders to be over dramatic in their statements and will review the onslaught of the recent menthol initation/cessation studies with a critical eye.
Tuesday, December 14, 2010
New Surgeon General’s Report Blows FDA Tobacco Act Out of the Water; Shows that Anti-Smoking Groups Were Untruthful in Their Public Statements
Although the Surgeon General’s claim that a single cigarette can kill you has been gaining the most attention, there is another major conclusion of the Surgeon General’s report that is far more meaningful. The report reviews evidence regarding the basic approach to reducing tobacco-related disease that was taken in the Family Smoking Prevention and Tobacco Control Act (the Tobacco Act): lowering levels of specific toxic constituents in tobacco smoke.
A major conclusion of the report is that there is no evidence that reducing levels of specific tobacco smoke constituents will lead to a decrease in human disease.
The report concludes that: “the evidence today does not demonstrate that efforts to lower machine-measured tar and nicotine yields actually decreased the health risks of smoking.” Furthermore, “no relationship exist[s] between machine-measured tar and nicotine levels and risks for most categories of cigarette-related diseases.”
The report emphasizes that “changes to reduce machine-measured tar and nicotine yields in cigarettes did not have a measurable beneficial impact on public health.”
The report notes that even when cigarette companies reduced nitrosamine levels by 70%, there was no evidence of any reduction in health risk of these new products: “For example, Brown & Williamson introduced Advance as a new cigarette with the claim that levels of tobacco-specific nitrosamines (TSNAs) were 70 percent lower than those in leading “light” brands (Star Scientific 2005). Preliminary laboratory studies of cigarette smokers provide mixed evidence for the possibility that use of this cigarette substitute would result in reduced exposure to tobacco toxicants (Breland et al. 2002, 2003). Omni, manufactured by Vector Tobacco, is a conventional cigarette for which the marketers claimed lower levels of carcinogenic polycyclic aromatic hydrocarbons, nitrosamines, and catechols (Vector Group 2001). Preliminary studies in which Omni is smoked instead of the smokers’ usual brand of cigarettes provide little evidence for reduced exposure to toxicants (Hatsukami et al. 2004b; Hughes et al. 2004).”
One reason for the absence of any relationship between levels of toxicants and product risk, according to the report, is that “the extent to which exposure to toxicants is actually reduced in smokers is not known because reduced machine-measured yields of toxicants do not necessarily reflect actual human exposure.”
In fact, the report emphasizes that reductions in specific constituents in tobacco smoke may actually increase, rather than decrease, the risks associated with cigarette smoking: “products delivering lower levels of nitrosamines might theoretically reduce cancer risks, but because many of these products still deliver nicotine and CO, cardiovascular risks may remain unchanged or may even increase. In addition, if TSNAs are removed, other potent carcinogens may sustain overall high levels of exposure to carcinogens.”
Furthermore, disease risk associated with lower-emission cigarettes may increase, or remain unchanged, for the following reason: “A smoker who switches to a brand with lower machine-measured toxicants may smoke these cigarettes in a more intense fashion or may consume more cigarettes per day than previously. Either change could result in greater human exposure to toxicants and no decrease in risk of disease.”
Finally, the report notes that: “There are substantial risks that the marketing of novel cigarettes could lead to increased tobacco use in current smokers, relapse in former smokers, and initiation in those who never smoked, particularly youth.”
The Rest of the Story
The Surgeon General’s report destroys the entire scientific basis for FDA regulation of cigarettes: the contention that by lowering levels of various constituents in tobacco smoke, the FDA can mandate changes which will decrease the risk of disease and thereby improve the public’s health.
On the contrary, the Surgeon General’s report concludes that there is no scientific basis for the contention that lowering specific toxicants in cigarette smoke will reduce human disease. In fact, according to the report, such changes could actually increase overall disease in the population.
Not only does this blow the FDA Tobacco Act out of the water, but it also blows out of the water the FCTC’s proposed regulation of cigarette toxicant levels.
Furthermore, the Surgeon General’s report reveals that the anti-smoking groups lied to the American public when they claimed that regulating specific toxicant levels in cigarettes would save countless lives. There was no scientific evidence to support such a statement. Moreover, it is possible that such an approach could actually increase tobacco-related deaths.
I find it interesting that when a tobacco company introduces the idea of reducing levels of certain carcinogens or toxicants in their products, the anti-smoking groups attack the companies and tell the public that these companies are lying, acting fraudulently, and conspiring to defraud the American people. But when the anti-smoking groups claim exactly the same thing, the lie suddenly becomes truthful. What kind of magic do the anti-smoking groups possess that they can repeat the precise lies that the tobacco companies told, but have them instantaneously turn into the truth?
The answer, of course, is that there is no magic here. Tobacco-related disease risk is dictated by science, not magic. And so the rest of the story is that the anti-smoking groups are lying to you. When they argue that regulating specific constituents in tobacco products is going to save countless lives, they are lying to you.
The World Health Organization, or at least its tobacco regulation group, is also lying to you.
You see, the truth is that the FDA regulation of tobacco products is a huge scam. You simply can’t regulate the safety of a product that is killing more than 400,000 Americans each year. It is an absurd notion to begin with. The entire idea is a scam set up to make it look like our politicians really care about reducing tobacco-related disease, but without having to actually take the courageous moves necessary to pass legislation that Philip Morris opposes and which therefore truly has the potential to save lives by substantially reducing tobacco use.
The scam was also set up to bring fame and glory to anti-smoking groups, allowing them to solicit contributions by boasting about how they brought Big Tobacco to its knees. All this without telling their constituents that the largest company in Big Tobacco actually supported the legislation and was not on its knees, but standing tall and strong and buttering up its bank accounts.
In fact, on the day that the anti-smoking groups congratulated themselves for removing so-called flavored cigarettes from the market, Philip Morris introduced a brand new flavored cigarette, exposing the anti-smoking groups for the frauds that they are.
The Surgeon General’s report reveals that the fraud goes even deeper than you might have thought. The entire premise for the FDA regulation of tobacco products – the idea that by lowering levels of certain constituents, lives can be saved – has now been demonstrated to be a fraudulent claim.
It is no less fraudulent simply because it is now anti-smoking groups which are making the claim instead of tobacco companies. Remember, the fraud is not a result of who is making the statement. It is a result of the lack of truth in the statement itself. And the statements that the anti-smoking groups have made – what they have led you to believe about how the FDA regulation of specific constituents in cigarettes is going to make the product safer and save lives – is untruthful. In fact, with all due respect to the tobacco companies, this may be the greatest fraud in tobacco control history