Transcript Document

EVALUATING THE SCIENCE BASE FOR ASSESSING CLAIMS OF REDUCED
RISK FOR TOBACCO BASED POTENTIAL REDUCED EXPOSURE PRODUCTS
Kara D. Lewis, Amy M. Brownawell, Michael C. Falk, Keith Lenghaus, Paula M. Nixon, Catherine St. Hilaire
The Life Sciences Research Office, 9650 Rockville Pike, Bethesda, Maryland 20814.
ABSTRACT
APPROACH
The Life Sciences Research Office, Inc. (LSRO), a Bethesda, Maryland-based non-profit
organization that provides scientific evaluation, analysis and advice of biomedical research
scientists, is evaluating the science base necessary to support claims of reduced risk for
tobacco-based “potential reduced exposure products” (PREPs) and identifying areas of
research where additional information could contribute to an assessment of reduced risk. If
the current state of the science is adequate, LSRO will develop a scientific framework for
assessing whether tobacco PREP products are likely to decrease the risk of cancer,
cardiovascular disease and chronic obstructive pulmonary disease for tobacco product
users. The aim of the project is to extend the work described in the Institute of Medicine
(IOM) report Clearing the Smoke: Assessing the Science Base for Tobacco Harm
Reduction (CTS) by providing further detail on approaches reviewed in CTS and
evaluating scientific approaches developed since the IOM report was published in 2001.
LSRO has assembled four committees of experts with diverse, relevant backgrounds to
advise the project. The Core Committee will evaluate the state of the science within a risk
assessment framework for potential reduced risk tobacco products and provide overall
guidance for the project. Three satellite committees will review the current state of the
science for tobacco product related Hazard Identification and Dose Response Assessment,
Individual Exposure Assessment, and Population Exposure and Behavior Assessment. The
reports produced by the state-of-the-science review committees will provide the basis for
the Core Committee’s risk assessment framework. LSRO held an Open Meeting in April,
2005 to solicit public comment on the project and the Core Committee has met five times
to date. The state of the science review committees have been meeting over the last several
months and summaries of their findings will be forwarded to the Core Committee in early
2006. The project is sponsored by Philip Morris USA.
The Reduced Risk Review will evaluate the science base necessary to assess whether
potential reduced-risk tobacco products are likely to reduce the risks of cigarette smoking
by identifying and evaluating:
•Exposure characteristics of potential reduced-risk products under conditions of actual
use,
•Surrogate biological markers of lung cancer, cardiovascular disease, and chronic
obstructive pulmonary disease,
•Potential population risks and groups at greatest risk associated with potential reduced
risk tobacco products, and
•Methods to predict or estimate population risk prior to marketing and to monitor
population risk after a potential reduced risk tobacco product is marketed.
BACKGROUND
Medical, scientific, and public health organizations have concluded that the best way to
protect individual and public health from tobacco harms are to achieve abstinence,
prevent initiation and relapse, and eliminate environmental tobacco smoke exposure.
However, consideration is also being given to the concept that reducing adverse effects
on the health of tobacco-users who will not or can not abstain from the use of tobacco
products (i.e., risk-reduction) may also be a valuable component of a comprehensive
tobacco control program (Institute of Medicine, 2001).
LSRO’s Reduced Risk Review builds on the work of a committee of the Institute of
Medicine (IOM) to formulate scientific methods and standards for assessing ‘potential
reduced-exposure products’ (PREPs) detailed in the report, Clearing the Smoke:
Assessing the Science Base for Tobacco Harm Reduction (Institute of Medicine, 2001).
In contrast to the IOM report, the Reduced Risk Review addresses only tobacco based
products and refers to them as ‘potential reduced risk tobacco products’. The specific
findings and recommendations of the IOM report serve as the departure points for the
LSRO study.
LSRO STUDY OBJECTIVES:
• To provide an independent, comprehensive evaluation of the science base necessary to
determine whether potential reduced-risk tobacco products are likely to reduce risk,
• To develop a detailed research agenda to address gaps in the science base and, if
feasible,
• To develop an evaluative process for the scientific assessment of potential reducedrisk tobacco products.
PROCESS
Expert Committees
A Core Committee of experts from diverse relevant disciplines is providing oversight of
the project, and is responsible for the assessment of potential reduced-risk tobacco
products. Three state-of-the-science review committees, Hazard Identification and DoseResponse Assessment (HIDRA), Individual Exposure Assessment (IEA), and Population
Exposure and Behavior Assessment (PEBA), will address scientific questions relevant to
the project (Figure 1).
The HIDRA Committee is identifying and reviewing currently available in vitro assays,
animal models, and clinical studies that can be used to arrive at scientific conclusions
regarding reduced-risk for tobacco products. The primary focus will be on the
identification of human studies that are able to provide information on the risk of lung
cancer, cardiovascular disease, and chronic obstructive pulmonary disease.
Work Product
The results of these investigations and deliberations will be presented as a Reduced Risk
Core Committee report with an expected completion date of July 2006. State-of-the-science
reports from the HIDRA, IEA, and PEBA Committees are expected in late 2006.
CORE COMMITTEE
Alwynelle Ahl, Ph.D., D.V.M.
Highland Rim Consulting, Inc.
Lyles, TN
Elizabeth Anderson, Ph.D.
Sciences International, Inc.
Alexandria, VA
Nancy L. Buc, Esq.
Buc & Beardsley
Washington, D.C.
Carroll Cross, M.D.
School of Medicine
University of California, Davis
Davis, CA
Louis D. Homer, M.D., Ph.D.
Legacy Research
Portland, OR
Joseph V. Rodricks, Ph.D.
ENVIRON International
Arlington, VA
Emanuel Rubin, M.D.
Jefferson Medical College
Thomas Jefferson University
Philadelphia, PA
Richard C. Schwing, Ph.D.
Sustainable Visions, Inc.
West Bloomfield, MI
Richard Windsor, M.S., Ph.D., M.P.H.
School of Public Health and Health
Services
George Washington University
Washington, D.C.
Figure 1. . Committee Structure of the Reduced Risk Review Project.
CORE COMMITTEE
The IEA Committee is evaluating current methods for determining external and internal
exposure to constituents of smokeless tobacco products and tobacco smoke (both for
users of tobacco products and individuals passively exposed to environmental tobacco
smoke) that can be applied to draw scientific conclusions as to whether tobacco products
are likely to reduce exposure associated with cigarette smoking.
The PEBA Committee is assessing the potential consequences on the population of the
availability of potential reduced-risk tobacco products both the potential consequences on
the population of the availability of potential reduced-risk tobacco products and
surveillance methods of population level use patterns. Some specific issues being
addressed include altered initiation/recruitment of non-smokers (especially adolescents)
and changes in patterns of cessation and relapse.
Meetings
LSRO held an Open Meeting in April 2005 to encourage input from scientific and other
interested parties. Approximately 75 people attended the all-day meeting to listen to
presentations from academic and industry speakers. Written comments submitted to
LSRO prior to and following the Open Meeting have been forwarded to the Core
Committee members for their consideration. Comments on the project are welcome
throughout the course of the project.
The Core Committee has convened five times to discuss the structure and content of the
report and has additional meetings planned for the first half of 2006. State-of-the-science
review committee meetings are planned through late 2005. Committee meetings of the
Reduced Risk Review Project usually include an information-gathering session at the
beginning of each meeting that is open to the public. Individuals interested in attending
should register via the LSRO website (www.LSRO.org).
HIDRA
IEA
PEBA
ASSESS ADVERSE
HEALTH EFFECTS
REDUCTION
ASSESS
EXPOSURE REDUCTION
ASSESS
POPULATION EFFECTS
REFERENCES
Institute of Medicine (2001) Clearing the Smoke. Assessing the Science Base for
Tobacco Harm Reduction. (Stratton, K., Shetty, P., Wallace, R. & Bondurant, S., eds. ).
Washington, DC: National Academy Press.
About LSRO: History and Mission
Since 1962, the Life Sciences Research Office (LSRO) in Bethesda, MD has provided
clients with expert evaluation of issues, opportunities, data, programs, and proposals
in basic and clinical research. LSRO has carefully built an international reputation for
objectivity and is regarded as a widely accepted authoritative source, independent
from special interest groups and politics. LSRO reports are timely, comprehensive,
state-of-the-science reviews. Moreover, LSRO’s experience with regulatory and
governmental processes has proven useful to clients from the public and private
sector alike. For more information, please refer to www.LSRO.org. Funding for this
project was provided by Philip Morris USA.