In a two-part series for his blog, Tobacco Analysis, ACSH advisor Dr. Michael Siegel, a professor in the Department of Community Health Sciences at the Boston University School of Public Health, details the most serious barrier yet to tobacco harm reduction. Dr. Siegel explains how the recent Institute of Medicine (IOM) recommendations to the FDA, which pertain to the marketing of modified risk tobacco products (MRTPs), will, if implemented, present a blockade to the development and approval of such products. It would, in fact, be a death blow to tobacco harm reduction and to our nation s 45 million addicted smokers.
According to the IOM report, MRTPs should not be promoted as less risky alternatives to smoking unless extensive clinical trials and long-term longitudinal studies can demonstrate this. The monumental effort necessary to obtain this evidence, however, must be conducted by an independent third-party lab. The makers of MRTPs specifically tobacco manufacturers are strictly prohibited from conducting these trials, even though they re best equipped both scientifically and financially to undertake such financially exorbitant long-term projects.
And even if such a study does get off the ground, it must demonstrate that the MRTP is either a reduced risk product (indicating that it is safer than other products on the market) or a reduced exposure product that is, it delivers less of a particular substance although the manufacturer can make no health claims regarding the product s safety. Yet as Dr. Siegel points out, the studies that would be necessary to demonstrate that an MRTP is reduced risk would require many thousands of study subjects over very long periods of time, making it virtually impossible for any such product to be approved by the FDA. And if companies attempt instead to show that MRTPs reduce exposure to particular tobacco components, the recommendations state that consumers cannot be led to believe that lower exposure equates with a reduced risk of adverse health effects. As you might imagine, this again creates an almost impossible task for anyone aiming to inform consumers that MRTPs pose a lower risk to their health, compared to addictive, lethal cigarettes even though this is clearly the case.
As Dr. Siegel says, if the FDA were to follow the IOM suggestions, such onerous regulations would essentially nix harm reduction as a viable tobacco control strategy in favor of protecting the existing high-risk cigarette market. Anti-smoking groups who rally against MRTPs are not interested in actually protecting the health of smokers by encouraging them to use potentially less harmful alternatives, Dr. Siegel adds. The recent IOM recommendations sacrifice the health of smokers by making it impossible for tobacco companies or public health groups to pursue a harm reduction strategy, he writes, and it preserves the existing market of the highest risk tobacco products and stifles competition from alternative products that might truly reduce health risks. We couldn t have said it better ourselves.
We here at ACSH, like Dr. Siegel, wonder how such counterproductive requirements made it into the FDA tobacco bill in the first place. In whose interest was it to bar reduced risk products while protecting the lucrative cigarette market from competition from these safer products?