A recent University of Minnesota report on potential reduced exposure products (PREPS) has generated considerable discussion among tobacco control researchers and practioners about the apprpriate role of such products in an overall tobacco control strategy. The discussion over reduced risk products is also a central part of the debate over the Campaign for Tobacco-Free Kids and Philip Morris-supported FDA legislation that Congress is currently considering.
But there is a fundamental paradox in the entire idea of a reduced risk product approach that I have not seen mentioned.
The Rest of the Story
The only way to know for sure whether a new type of cigarette reduces health risks is to study the long-term effects of the use of that product among a relatively large number of smokers and to compare the risks with those of the use of conventional cigarettes. But how would such a study be done? Unlike testing the effects of drugs, which is done through a randomized trial, one could not ethically assign human subjects to smoke a conventional cigarette. Neither could one assign subjects to smoke a potentially reduced risk product. And even if one recruited a population of smokers who were already using a particular product, one could not instruct them to continue using that product. One would, in fact, be ethically obligated to deliver intense smoking cessation interventions to try to get all subjects to quit. Standard care, in this case, must be defined as trying to get the subject to quit smoking. Such studies could simply not be done, under ethical grounds, by scientific researchers at any kind of academic or government institution.
So what this means is that the only real way to conduct these studies is for the cigarette companies to do the studies themselves. And they can only do them by observing large numbers of smokers over a long period of time. By definition, a potentially reduced risk product would have to be marketed to people before knowing the risks of that product. But this brings up an interesting question? Should the companies inform the consumer that the product being tested is a potential reduced risk product? If consumers are so informed, then this may be viewed as the cigarette companies making unsubstantiated health claims. If consumers are not informed, then they are essentially being used as guinea pigs with no idea that they are actually serving as subjects in research. While this violates basic standards of human subjects research in academic and government settings, the tobacco companies are not subject to these standards, and so perhaps such research would be acceptable. But it would certainly represent the withholding of critical information from consumers.
Perhaps a more pressing problem would be the difficulty of marketing a new product without being able to make any health claims. Why would smokers switch from the well-established, well-marketed cigarette brands to a new product that is not being promoted based on a claim of potential health benefit. How many entirely new cigarette brands have been successfully marketed in the past two decades based on anything other than a potential health claim or simply based on low price? And it is unlikely that the costs of the required research project would enable a cigarette company to test market a low-priced product.
This is truly a dilemma. In order to be able to substantiate potential reduced risk health claims, cigarette companies must do long-term research to study the effects of the product in large human populations. But in order to feasibly conduct that research, companies would need to be able to market the product based on a claim of potential health benefit, that is, by definition, unsubstantiated.
I think there are two reasonable responses to this dilemma, and one unreasonable one.
The first reasonable response would be to simply abandon any efforts to promote the development of reduced risk cigarettes. We would simply concentrate our efforts on reducing the demand for the existing products. If cigarette companies, on their own, market potentially reduced risk products, we would monitor the marketing claims to make sure that no unsubstantiated health claims were being made. Such an approach would likely deter the development of such products, since as I argued above, companies could not likely successfully market a new product without being able to make some sort of health claim. There would be likely be little change in the existing market.
A second reasonable response might be to encourage companies to develop reduced risk products, and to provide an incentive that would make this feasible by allowing companies to inform their customers that the product is a potentially reduced risk product. This would likely encourage the development and testing of reduced risk products and the market competition would likely result in substantial changes in the existing market (although it is unclear whether the changes would result in safer cigarettes or not).
The one approach that seems completely unreasonable would be to tightly regulate the marketing of potential reduced risk products such that companies cannot make any health claims unless they are substantiated, but to allow reduced exposure claims to be made without any substantiation. Such an approach would completely stifle any development of reduced risk products, but would allow the marketing of products that merely reduce exposure to one or more substances under unsubstantiated health claims (which will likely mislead consumers into thinking the product is safer). This would both eliminate the possibility of any meaningful changes in the safety of the product and undermine the basic goal of preventing companies from making misleading health claims, which would likely encourage smoking.
This last approach is in fact the approach that is being promoted by Philip Morris and by the Campaign for Tobacco-Free Kids, and is embodied in the FDA tobacco legislation that is currently being considered by Congress.
If anything is clear from this paradox, it should be that the focus of tobacco control efforts must remain on the movement to reduce the demand for tobacco products. If reduced risk product advantages come, they will only come from a competitive marketplace (unlike that proposed in the FDA legislation), and then, they will only come at the expense of allowing tobacco companies to market cigarettes based on their potential health benefits.