Transcript Document

Evaluating the Scientific Evidence for Potential
Reduced Risk Tobacco Products
Amy M. Brownawell, Michael C. Falk, Keith Lenghaus, Kara D. Lewis, Paula M. Nixon, Catherine St. Hilaire
The Life Sciences Research Office, 9650 Rockville Pike, Bethesda, Maryland 20814.
ABSTRACT
PROCESS
CORE COMMITTEE
The Life Sciences Research Office (LSRO), a non-profit biomedical research
organization, is evaluating the science base necessary to substantiate scientific
conclusions for potential reduced-risk tobacco products and is identifying critical
research gaps. If feasible, LSRO will also develop an evaluative process for the
scientific assessment of potential reduced-risk tobacco products. This review is
intended to build on the findings and recommendations of a Committee of the Institute
of Medicine, which are detailed in the report, Clearing the Smoke: Assessing the Science
Base for Tobacco Harm Reduction. LSRO has convened a multidisciplinary advisory
committee to guide the project and provide a risk characterization. Satellite committees
will provide independent analyses of the state-of-the-science in three areas: hazard
identification and dose-response assessment, individual exposure assessment, and
population exposure and behavior assessment. This project is sponsored by Philip
Morris USA.
Expert Committees
Alwynelle Ahl, Ph.D., D.V.M.
Highland Rim Consulting, Inc.
Lyles, TN
Joseph V. Rodricks, Ph.D.
ENVIRON International
Arlington, VA
Elizabeth Anderson, Ph.D.
Sciences International, Inc.
Alexandria, VA
Emanuel Rubin, M.D.
Jefferson Medical College
Thomas Jefferson University
Philadelphia, PA
BACKGROUND
Medical, scientific, and public health organizations have concluded that the best means
to protect individual and public health from tobacco harms are to achieve abstinence,
prevent initiation and relapse, and eliminate environmental tobacco smoke exposure.
Consideration is also being given to the concept that reducing adverse impacts on the
health of tobacco-users who will not or can not abstain from the use of tobacco products
(i.e., risk-reduction) may be a valuable component of a comprehensive tobacco control
program (Institute of Medicine, 2001).
The Reduced Risk Review builds on the work done by a Committee of the Institute of
Medicine (IOM), which culminated in the report, Clearing the Smoke: Assessing the
Science Base for Tobacco Harm Reduction (Institute of Medicine, 2001). The IOM
Committee concluded that “…there can be a successful, scientifically-based harm
reduction program that is justifiable and feasible − but only if implemented carefully
and effectively…” 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.
APPROACH
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,
• Specific diseases/adverse health outcomes associated with significant morbidity and
mortality caused by smoking,
• Surrogate biological markers associated with lung cancer, chronic obstructive
pulmonary disease, and cardiovascular disease,
• Changes in smoking behavior and/or alternative tobacco use that could adversely
impact the potential for risk reduction,
• Behavioral/psychological indicators for increased rates of tobacco usage associated
with the introduction of potential reduced-risk products, and
• Surveillance approaches for potential reduced-risk products.
LSRO is conducting the work of the project through two parallel processes. A Core
Committee of experts from relevant disciplines is providing oversight of the project and
is responsible for the development of a testing and peer-review process to assess
potential reduced-risk tobacco products. Three state-of-the-science review committees,
Hazard Identification and Dose-Response Assessment (HIDRA), Individual Exposure
Assessment (IEA), and Population Exposure and Behavior Assessment (PEBA), will
address critical scientific questions related to the completion of this project (Figure 1).
The HIDRA Committee is identifying and reviewing the current state of the science
relating to biological methods employed in the analysis of the effects of tobacco use,
highlighting currently available assays, models, and markers that can be used to draw
scientific conclusions regarding potential reduced-risk for tobacco products. The
primary focus is on the identification of human studies that are able to provide
information on the risk of cancer, cardiovascular disease, and chronic obstructive
pulmonary disease. In vitro assays and animal models that could support a conclusion of
reduced-risk in humans are also being considered.
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 assess potential reduced-risk tobacco products. The IEA
Committee is evaluating the validity and utility of various exposure assessment methods
as components of a comparative risk assessment. Issues related to the characterization
of study populations are also being addressed.
The PEBA Committee is assessing both the potential consequences on the population of
the availability of potential reduced-risk tobacco products and surveillance methods of
population level use patterns and disease outcomes. Some specific consequences being
addressed include altered initiation/recruitment of non-smokers (especially adolescents)
and changes in patterns of cessation and relapse.
Meetings
LSRO hosted an Open Meeting in late April 2005 to encourage input from scientific and
other interested parties. Approximately 75 people attended the all-day meeting to listen
to presentations from both 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 from interested parties are
welcome at any time during the course of the project.
The Core Committee has convened four times to discuss the structure and content of the
report and has additional meetings planned for late 2005 and the first half of 2006. The
HIDRA, IEA, and PEBA Committees have meetings planned through late 2005. Every
committee meeting of the Reduced Risk Review Project includes an informationgathering session, usually at the beginning of each meeting, which is open to the public.
Individuals interested in attending should register via the LSRO website
(www.LSRO.org).
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-thescience reports from the HIDRA, IEA, and PEBA Committees are expected in late 2006.
Nancy L. Buc, Esq.
Buc & Beardsley
Washington, D.C.
Richard C. Schwing, Ph.D.
Sustainable Visions, Inc.
West Bloomfield, MI
Carroll Cross, M.D.
School of Medicine
University of California, Davis
Davis, CA
Louis D. Homer, M.D., Ph.D.
Legacy Research
Portland, OR
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
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.