The 130th Annual Meeting of APHA

Abstract #39333

Mark parascandola, Cancer Prevention Fellowship Program, National Cancer Institute, 6130 Executive Blvd., Suite 3109, Bethesda, MD 20892, 301-594-1576, paramark@mail.nih.gov

There is currently renewed interest and optimism, among tobacco manufacturers, the pharmaceutical industry, and the tobacco control community, for the pursuit of tobacco harm reduction as a viable public health strategy. Harm reduction is the idea that in addition to assisting individuals in abstaining from or quitting smoking, the tobacco control community should aid the development of tobacco products associated with lower excess morbidity and mortality. However, the harm reduction strategy introduces a number of novel ethical challenges that must be addressed before pursuing further research and regulatory efforts in this area. At the population level, tobacco harm reduction remains experimental as a public health intervention and may have unanticipated negative effects, as evidence by the failure of early low tar and low nicotine products. While harm reduction has been a successful strategy in some situations, such as the use of seat belts in automobiles or the reduction of unwanted side effects in therapeutic products, the harms posed by tobacco exposure are not offset by any benefits to the user. At the level of the individual, the evaluation of reduced harm tobacco products creates difficulties for the protection of human subjects in clinical research. For example, in randomized trials the conventional standard of clinical equipoise will not be met for harm reduction products, because smoking cessation will be the recommended preventive clinical strategy. While harm reduction can be an acceptable strategy under certain circumstances, its application in tobacco control must address unique ethical challenges.

Learning Objectives: By the end of this session, the participant will be able to

• Define harm reduction as a public health strategy.
• Recognize why harm reduction remains experimental with regard to tobacco use.
• Identify unique challenges in tobacco harm reduction research that threaten the protection of human research subjects.

Keywords: Tobacco Control, Ethics

Presenting author's disclosure statement:
I do not have any significant financial interest/arrangement or affiliation with any organization/institution whose products or services are being discussed in this session.