A June 12 article in The New York Times Magazine presents a detailed discussion of the issue of PREPs (potentially reduced-exposure products) and their potential role as a tobacco control harm reduction strategy (see: Gertner J. Incendiary Device. The New York Times Magazine. June 12, 2005).
The article focuses on a new type of cigarette, called Fact, which utilizes a special filter which apparently removes a number of carcinogenic components of the tobacco smoke and substantially reduces the smoke's mutagenic activity. The cigarette, produced by an independent tobacco company in North Carolina using the special filter produced by a biotechnology company (Filigent) in Hong Kong, is reported to go on sale later this month in several states.
The introduction of PREPs, like Fact, into the marketplace also introduces a number of very difficult scientific and public policy issues for tobacco control practitioners. If they are indeed effective in eliminating or greatly reducing an entire class of toxic or carcinogenic constituents in tobacco smoke across the board, such products could have a huge positive impact on the public's health by reducing smoking-related disease and mortality risks. On the other hand, since the chemistry of tobacco pyrolysis is extremely complex, these new technologies could potentially result in increased levels of other toxins. Moreover, it is difficult to determine the impact of these PREPs on human disease rates and it would take many years to conduct the longitudinal studies necessary to make such determinations. Finally, it is a theoretical possibility that even if PREPs reduce disease risks, the overall public health burden of smoking could actually increase if the result of these PREPs is to convince smokers who might otherwise have quit entirely to switch to a reduced-risk cigarette.
The Rest of the Story
In the article, Dr. Ken Warner, long-time tobacco control researcher and policy expert and new dean of the School of Public Health at the University of Michigan, calls the debate over PREPs "the most complicated thing I've ever encountered in 30 years of working on tobacco policy." In light of Dr. Warner's statement (and he has far greater experience in this area than I do), I am afraid that I cannot offer any easy answers to this dilemma. But I do think the article sheds light on a number of points that are clear and which are important for tobacco control practitioners and advocates to understand.
First, if it is unclear whether a new technology that filters out entire classes of toxic compounds will improve the public's health, there is certainly no basis for claiming that a federal regulation that may reduce or eliminate a number of specific smoke constituents is going to save lives. However, this is exactly the kind of nonsensical claim that is being made by many public health organizations in supporting the currently proposed FDA tobacco legislation.
As the article explains: "The science of tobacco is so murky, and the links between the components of smoke and illness so tenuously understood, that many researchers question whether reducing the exposure of smokers to certain chemicals can actually reduce the risk of disease. What's more, a so-called safer cigarette that removes some carcinogens might inadvertently raise the levels of other toxins, a phenomenon that has already been observed in some PREP's."
So the first thing that I think is clear is that an approach of regulating certain specific toxins, as proposed in the FDA legislation, makes no sense and contrary to statements of many public health groups, there is no basis to claim that it will save lives.
Second, it will be extremely difficult to evaluate the public health impact of any new PREPs and at best, such an evaluation will take many years, probably decades. This means that it will be virtually impossible for any cigarette company to meet the burden of proof required by the proposed FDA legislation before a reduced risk product can be marketed. Because the FDA legislation requires that a manufacturer demonstrate that the proposed reduced risk product will "significantly reduce harm and the risk of tobacco-related disease to individual tobacco users; and benefit the health of the population as a whole taking into account both users of tobacco products and persons who do not currently use tobacco products," the FDA legislation essentially represents a ban on reduced risk products, as it creates an impossible burden for tobacco companies and takes away any incentive to research, develop, and market what may be true reduced risk tobacco products.
As the article explains: "Any reliable epidemiological studies on smokers are longitudinal in nature, meaning they can require several decades and a large group of subjects to show meaningful results. It hasn't been until the last few years, for instance, that public health officials have begun to correlate the rise in adenocarcinoma, a cancer deep in the lungs and often difficult to detect, to the introduction of the low-nicotine light and ultra-light cigarettes that became popular in the 1970s and 1980s. ... it could be 20 years before anyone understands just how well, or how poorly, Filigent works. ... it's possible we may never understand."
Third, if it could be 20 years before anyone understands just how well or how poorly a new filter (which reduces an entire class of toxins) works, then there is no basis on which to allow cigarette companies to make claims of reduced health risks for a product that merely reduces or eliminates one tobacco smoke constituent. Yet that is essentially what the proposed FDA legislation would do. Cigarette companies could market a product as a "reduced risk" product if it appears to reduce the level of even a single cigarette component. The company merely has to show that it anticipates that long-term studies will demonstrate a health benefit. Specifically, the company need only demonstrate that: "the scientific evidence that is available without conducting long-term epidemiological studies demonstrates that a measurable and substantial reduction in morbidity or mortality among individual tobacco users is anticipated in subsequent studies."
The problem is that a reduced exposure claim is almost certainly going to be interpreted by the public as meaning that the product will reduce health risks. In this way, the FDA legislation essentially institutionalizes the ability of cigarette companies to make unsubstantiated health claims (or at least, claims that will be interpreted by the public as health claims).
Finally, given the potential for a substantial benefit of reduced risk products and even taking into account the possible harms of such a harm reduction approach, it seems prudent to at least keep the door open for such an approach while the public health community considers the issues. Enacting the FDA legislation currently on the table would immediately and for all time end the debate by eliminating the possibility of true reduced risk tobacco products as a harm reduction strategy in tobacco control.
The answers to the difficult questions posed by the introduction of potentially reduced-exposure products are not readily available and much more discussion is warranted; however, one thing is quite clear. The FDA legislation currently supported by Philip Morris and a large number of public health groups is not the answer.