DEVELOPED FOR POTENTIAL
REDUCED-RISK TOBACCO PRODUCTS Press Release Modified tobacco products may reduce risks for smokers who will not quit. What methods are needed to assess risks associated with these substitutes for conventional cigarettes prior to marketing?
BETHESDA, MD - (April 24, 2007) - A new study from the Life Sciences Research Office, Inc. (LSRO), Scientific Methods to Evaluate Potential Reduced-Risk Tobacco Products, outlines laboratory and clinical testing approaches for the assessment of tobacco products with the potential to reduce the risks of cigarette smoking for individuals who switch from cigarettes to these products.
LSRO, aided by 26 independent experts on smoking and disease, human health risk assessment, and public health policy, found that existent scientific methods are adequate and developed a comprehensive method to compare the health effects of potential reduced-risk tobacco products (PRRTPs) and conventional cigarettes.
Background
According to the Centers for Disease Control and Prevention (CDC), more than 400,000 people die each year in the U.S. because they smoke cigarettes. Approximately half of all smokers die prematurely, losing on average 13-15 years of life. Despite the widespread knowledge of the risks posed by tobacco use, almost one out of every five U.S. adults smokes.
Quitting is the most effective strategy for eliminating the risks from cigarette smoking. This, unfortunately, is easier said than done even though 70% of smokers want to stop smoking and 34% attempt to quit each year. The CDC reports only 2.5% of all smokers successfully quit.
Although smoking prevalence has declined, the absolute number of smokers has not changed for more than a decade. That is, approximately 45 million adults are cigarette smokers and remain at high risk of dying prematurely.
Several tobacco companies have marketed products intended to reduce the risks of smoking; however, an independently developed comprehensive testing and evaluation process to determine if risks are likely to be reduced was not available prior to the LSRO study.
Conclusions and Recommendations
LSRO developed the following major conclusions and recommendations:
Reliable testing and assessment methods for risk reduction in individual smokers are currently available for premarket evaluation of PRRTPs.
PRRTP assessments should focus on the risks posed by the three most deadly diseases caused by cigarette smoking: lung cancer (LC), chronic obstructive pulmonary disease (COPD), and cardiovascular disease (CVD).
Data needed to evaluate risk reduction of PRRTP use in individual smokers must be derived from comprehensive and complementary preclinical and clinical testing.
Preclinical studies that are recommended to fully characterize a PRRTP include product characterization, smoke chemistry studies, cytotoxicity and genotoxicity assays, and animal toxicology studies.
Clinical studies that are recommended include studies of biomarkers of exposure for smoke emission constituents and whole smoke and studies of biomarkers of effects associated with the risk of developing LC, COPD, and/or CVD in order to assess the product as it will actually be used by a representative sample of current smokers.
Two broad categories of product controls for PRRTPs were identified: reference cigarettes, which are used to ensure analytic accuracy, and commercially available, conventional cigarettes that are representative of the market at the time of testing.
The well-established risk assessment process used by US regulatory agencies to identify hazards and estimate risks provides an appropriate framework for the premarket evaluation of the effect of PRRTPs on disease risks of smokers who cannot or will not quit smoking.
The intended effect of a PRRTP is to decrease the risk of disease in smokers. Unintended effects could also occur after a PRRTP is marketed if it engenders an increase in the number of smokers who would otherwise be tobacco-free LSRO reviewed methods to assess the likelihood of such unintentional effects and concluded that currently available methods are inadequate to predict potential increases in the prevalence of smoking prior to marketing.
Postmarketing population assessment studies, consisting of a combination of clinical, behavioral, and epidemiological methods, will be necessary to detect intended and unintended public health consequences that may result from the introduction of a PRRTP. Both short-term (months to a few years) and long-term (for periods as long as 10 years or more) studies should be conducted to assess the overall impact of a PRRTP on population risk.
All of the above findings and recommendations are science-based; however, LSRO recognizes that public health policies transcend science and often determine the degree to which various types of scientific evidence are used to make decisions related to the use of health claims and other marketing approaches for PRRTPs. LSRO observes that the high risk of death and disease currently borne by smokers should be the primary consideration in premarketing assessments of PRRTPs.
This report and the scientific evaluation approach outlined by LSRO will be of interest to a number of audiences including academic, government and industry researchers; tobacco control and public health organizations; agencies with regulatory oversight of tobacco products, such as the Federal Trade Commission; as well as individuals involved in the development of legislation providing regulatory authority over tobacco products to public health organizations, such as the Food and Drug Administration, and agency staff. The report will also be of interest to current smokers (and their friends and family) who are unable or unwilling to quit smoking but are interested in reducing their risks due to smoking.
This report was produced under a contract between Philip Morris USA, Inc. (Philip Morris) and LSRO. Findings, conclusions, and recommendations were developed independently of Philip Morris and represent the views of LSRO. *** The Life Sciences Research Office, Inc. (LSRO) is an internationally recognized, non-profit organization located in suburban Washington, D.C. For nearly half a century, LSRO has provided expert objective scientific evaluations to governmental agencies and leading corporations in the food, consumer products, health, and biomedical sectors. A major focus at LSRO is the development of ad hoc reviews conducted by expert scientists actively engaged in research. Over 375 reports have been published since LSRO's establishment in 1962. LSRO is a leading authority in providing science-based analysis and advice that has proven integral to the development of sound policies and regulations on the national and international level. *** Note:
Read the Executive Summary of the report
Purchasing Information
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Editor's Note: The report is available to the press. To receive a copy and schedule an interview with an LSRO staff member, please contact Dr. Michael Falk at 301.634.7030 or falkm@lsro.org
