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American Public Health Association
133rd Annual Meeting & Exposition
December 10-14, 2005
Philadelphia, PA
APHA 2005
 
3255.0: Monday, December 12, 2005 - 3:06 PM

Abstract #113357

What the evidence shows: Biomarkers and "harm reduction" products

Dorothy Hatsukami, PhD, Tobacco Use Research Center, University of Minnesota, 2701 University Avenue SE, Suite 201, Minneapolis, MN 55414, 612-627-1808, hatsu001@umn.edu and Stephen S. Hecht, PhD, Analytical Biochemistry Core, University of Minnesota Cancer Center, Box 806 Mayo, 420 Delaware Street SE, Minneapolis, MN 55455.

Human studies examining potential reduced exposure products PREPs are critical in determining their impact on individual and population harm. Several levels and types of testing of these products are essential: human clinical trials, pre-market consumer perception testing and post-marketing surveillance. This presentation will focus on methods and results associated with testing PREPs. In human clinical trials, which evaluate toxin exposure and health risks associated with the use of PREPs, the availability of surrogate biomarkers for disease and addiction that are both reliable and valid is crucial. A number of studies have been conducted that show biomarkers for exposure to nicotine and carcinogens and risk factors for cardiovascular disease are reliable and show a dose-response curve. However, to date, the level of exposure to toxins that would indicate reduction in disease risk or the necessary reduction in other risk factors that would be associated with beneficial health effects is unknown. Several human trials, both short-term and long-term, have been conducted with PREPs, with most of these studies demonstrating insufficient reduction in biomarkers to warrant any implied or direct claims of reduction in health risks. Yet, products are currently being marketed as reducing toxin exposure and in some instances, as potentially reducing risk for cancer or pulmonary disease. Studies show that these claims are being misinterpreted or over interpreted by consumers. The presentation is part of the session: Where's the Evidence: Reducing the Harm of “Harm Reduction” Products, moderated by Gail Bingham, gbingham@resolv.org, 202-965-6200.

Learning Objectives: At the conclusion of the session, the participant will be able to

Keywords: Smoking Cessation, Tobacco Policy

Presenting author's disclosure statement:

I wish to disclose that I have NO financial interests or other relationship with the manufactures of commercial products, suppliers of commercial services or commertial supporters WITH THE EXCEPTION OF Nicotine replacement products have been provided for our NIH funded studies by GlaxoSmithKline and Pfizer..

[ Recorded presentation ] Recorded presentation

Where's the Evidence: Reducing the Harm of Harm Reduction Products

The 133rd Annual Meeting & Exposition (December 10-14, 2005) of APHA