Tuesday, September 8, 2009
Public Health Physicians to the FDA: Don’t Write Off Current Smokers
On August 29 the American Association of Public Health Physicians (AAPHP), which has served as the national voice of directors of state and local health departments and other public health physicians, released a letter to Lawrence Deyton, the new director of the FDA Center for Tobacco Products. Over the signatures of Joel Nitzkin, chair of the organization’s tobacco control task force, and AAPHP president Kevin Sherrin, the letter counseled Deyton to “save the lives of 4 million or more of the 8 million adult American smokers who will otherwise die of a cigarette-related illness over the next twenty years” by “making smokers aware of selected smokeless tobacco products (including but not limited to snus and electronic cigarettes) that promise to reduce the risk of tobacco-related illness by 99% or better for smokers who are unwilling or unable to quit.”
AAPHP concerns stem from the July 22 FDA “condemnation of electronic cigarettes,” which I covered in a previous post, available here. It appears that the FDA is poised to regulate e-cigarettes as drug delivery devices, which would remove these demonstrably safer cigarette substitutes from the market until they could be proven by manufacturers to be safe and effective, a burdensome process requiring as many as ten years of research and tens of millions of dollars. But the biggest losers of FDA e-cigarette mis-regulation would be the hundreds of thousands who are already using them to reduce cigarette consumption or quit smoking altogether.
The AAPHP outlined a simple and practical regulatory strategy for e-cigarettes: “We urge FDA to reclassify electronic cigarettes from a drug/device combination to a tobacco product. This will enable FDA to immediately regulate manufacturing and impose marketing restrictions during this initial period of FDA Tobacco Center development. This reclassification will eliminate pressure on the several hundred thousand current American users of electronic cigarettes to switch back to the much more hazardous conventional cigarettes.”
The letter, entitled “Don’t Write Off Current Smokers,” also encourages Deyton to consider smokeless tobacco as a harm reduction alternative for smokers. Nitzkin and Sherrin note that “this year, about 400,000 American adult cigarette smokers will die of a tobacco-related illness,” and “virtually all heart and lung disease from cigarettes, and an estimated 98% of the cancer mortality, are due to direct inhalation of fresh products of combustion.” They observe that “even though smokeless tobacco products represent about 20% of nicotine intake in the United States, the number of deaths per year from these products is too small for reliable estimates from the CDC.”
Nitzkin and Sherrin point out the futility of conventional quit-smoking approaches that emphasize pharmaceutical nicotine: “The only discussion of current smokers has been limited to encouraging use of pharmaceutical products to aid cessation. This has been touted as doubling quit rates – but without mentioning that this doubling is from about 3% to about 5% per year. In other words, this option fails 95% of smokers willing to try it, even under study conditions with optimal counseling.”
Last year the AAPHP became the first medical organization in the U.S. to formally adopt a policy of “…encouraging and enabling smokers to reduce their risk of tobacco-related illness and death by switching to less hazardous smokeless tobacco products.” The scientific manuscript on which that endorsement was based is available on the organization website here.
Nitzkin and Sherrin describe the singular goal of AAPHP as “doing everything in our power to reduce tobacco related illness and death.” Lawrence Deyton would be wise to make that the singular goal of the FDA tobacco center as well, and to make harm reduction a priority for the nation’s 45 million smokers.