A new Institute of Medicine report unintentionally highlights the fatal folly of censoring truthful information about cigarette alternatives until their manufacturers can generate the sort of costly, time-consuming studies that federal regulators demand before approving new drugs. Under the Family Smoking Prevention and Tobacco Control Act, a "modified risk tobacco product," which is any tobacco product identified as safer than cigarettes, can be legally sold only after the Food and Drug Administration (FDA) certifies that it will "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." In making that determination, the FDA is supposed to consider "scientific evidence." The IOM report, which was mandated by the law, suggests what sort of scientific evidence will be necessary. The short answer: the sort of scientific evidence that no one is likely to collect.
- Composition and performance of the MRTP, including the amount of toxicants, such as carcinogens, and nicotine that the product contains and to which the user is exposed
- Addiction potential of the MRTP, including the likelihood that the product will reduce overall use of conventional tobacco products, and the potential that the product will attract new users
- Risk perceptions and communications about the MRTP, including the accuracy of consumer knowledge about the risks and benefits of MRTPs and the influence of advertising on consumer perception and knowledge
- Human health effects of the MRTP, including the risks of tobacco-related diseases or premature death from using the product
All that will require an extensive research program:
Multiple study designs will be necessary to generate credible and comprehensive evidence to guide regulatory decisions. One essential type of study is the randomized clinical trial, in which investigators conduct rigorous, controlled experiments that compare MRTPs to popular products on the market. Equally critical are observational studies, during which investigators observe the health effects of MRTP use in various groups of people over time.
When manufacturers submit an application to sell an MRTP, they will need to include a large amount and wide variety of scientific data. The challenge for the FDA will be evaluating not only the specific results of each study, but also the totality of the evidence, balancing the risks and benefits for public health. Thus, the FDA will need to establish systematic, objective, and transparent approaches for evaluating and integrating evidence. One approach is to develop and use mathematical models. Modeling could help FDA estimate the effects of an MRTP on behavior, use, and public health outcomes.
This research supposedly would be performed by newly created organizations that are both 1) willing to take tobacco industry money and 2) free of the industry's ethical taint. Perhaps they will be based in the extraterrestrial colonies that surely will exist by the time this dream is realized.
Bill Godshall of Smokefree Pennsylvania, a prominent advocate of harm reduction for smokers, observes that "the IOM committee is basically urging the FDA to impose a several-hundred-million-dollar tax on any tobacco company before it could truthfully inform smokers that a smokeless tobacco product is less hazardous than cigarettes." He complains that the standards urged by the committee are inappropriate in this context:
While the report correctly points out that NRT [nicotine replacement therapy] products [such as nicotine gum and patches] pose virtually no health risks, it ignores a half century of evidence documenting that smokeless tobacco products in Sweden and the U.S. have very similar health risks/benefit profiles… The IOM committee report also ignores the undeniable evidence that several million smokers in the U.S. and Sweden have already switched to smokeless tobacco products, and have significantly reduced their disease risks by doing so. The IOM committee's recommendation would require a tobacco company to conduct far more research than FDA requires drug companies to conduct on NRT products before they can be marketed as smoking cessation aids.
The IOM report's authors worry that "little is currently known about the products' health effects and whether they pose less risk than traditional tobacco products." Enough is known to say that smokeless products such as snus, e-cigarettes, and lozenges, because using them does not involve lighting tobacco on fire and inhaling the toxins and carcinogens thereby generated, are much safer than conventional cigarettes. Yet companies selling them are barred from saying so until they perform prohibitively expensive studies that would take years to complete. If the goal is to reduce smoking-related disease and death, that demand makes no sense, since cigarettes are already on the market and are indisputably much more dangerous than the alternatives. Smokers can dramatically reduce their health risks by switching to smokeless products. Suppressing the information that might encourage them to do so needlessly endangers their health. Godshall argues that the IOM approach "is terrible for public health because it urges the FDA to protect deadly cigarettes from market competition by far less hazardous smokefree alternatives."
Even if manufacturers could satisfy the government's demand for data, conclusively showing through population studies and double-blind clinical trials exactly how much safer their products are, the FDA could still say no. "A company that wants to market a lower risk tobacco product in the U.S.," the IOM panel notes, "must offer scientific proof to FDA that the marketing of the product will not only reduce harm to individual users, but also benefit the health of the population as a whole." That means the FDA can block the marketing of an undeniably safer cigarette alternative based on concerns about its impact on "persons who do not currently use tobacco products." As I have been arguing for years, that standard makes the FDA the consumer's enemy.