BATCo
Clearing the Smoke Assessing the Science Base for Tobacco Harm Reduction
Fields
- Named Organization
- University of Minnesota
- National Cancer Institute
- NRC
- European Institute of Oncology
- Food and Drug Administration
- Gallup Organization, The
- University of Nebraska
- RJ Reynolds Tobacco Company
- International Standards Organization
- University of Medicine and Dentistry of New Jersey
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- University of Pennsylvania
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- University of Pennsylvania
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- Campaign for Tobacco Free Kids
- University of Medicine and Dentistry at New Jersey School of Public Health
- R.J. Reynolds Tobacco Company
- Star Scientific, Incorporated
- Glaxo Wellcome Pharmacutical
- Phannacia Corporation
- VA Ann Arbor Healthcare System
- Fagerstrom Consulting
- National Chemicals Inspectorate, Sweden
- University of Pittsburgh and Pinney Associates
- Smoking and Health Action Foundation, Canada
- DL Azarnoff Associates
- Chemical Industry Institute of Toxicology, President Emeritus
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- Philip Morris
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- University of Texas
- NIH
- American Medical Association
- University of Maryland
- American Health Foundation
- National Institute of Health Guidelines Committee
- University of North Carolina
- Massachusetts Institute of Technology
- University of Michigan
- University of Vermont
- University of Rochester
- Columbia University
- Covington and Burling
- Johns Hopkins University
- Public Health Service
- National Research Council
- University of Alabama
- CDC
- Centers for Disease Control and Prevention
- Philip Morris Tobacco Company
- University of California, San Francisco
- Georgetown University
- ISO
- RJR
- Named Person
- Boyse, Sharon
- Hughes, JR
- Goldberg, SR
- Russell, MA
- Benowitz, NL
- Jarvis, M
- Jones, RT
- Gritz, ER
- Marlatt, GA
- Miller, WR
- Edwards, G
- Kozlowski, LT
- Jackson, WK
- Stockwell, T
- Pomerleau, OF
- Jarvik, M
- West, RJ
- West, R
- Hatsukami, DK
- Doll, R
- Rose, JE
- Hunt, WA
- Kozlowski, L
- Jacob, P
- Smith, TA
- Shiffman, S
- Childress, AR
- Henningfield, JE
- Pomerleau, CS
- Gorrod, JW
- Jenner, P
- Wahren, J
- Chait, LD
- Karras, A
- Nemeth-Coslett, R
- Foxx, RM
- Sidney, S
- Tekawa, IS
- Gairola, CG
- Pershagen, G
- Hoffmann, D
- Leichter, J
- Halliwell, B
- Sutherland, G
- Breslau, N
- Koopmans, JR
- Benowitz, Neal
- Hecht, SS
- Henderson, RF
- Blot, WJ
- Brownson, RC
- Belinsky, SA
- Fagerstrom, KO
- Molander, L
- Nitenberg, A
- Shields, PG
- Domino, EF
- Penn, A
- Snyder, CA
- Phillips, DH
- Collins, AC
- Kendler, KS
- Levin, ED
- Foulds, J
- Jones, HE
- Ames, BN
- Cummings, KM
- Tonnesen, P
- Perkins, KA
- Charlton, A
- Fielding, JE
- Borland, R
- Rigotti, NA
- Pentz, MA
- Glantz, S
- McCarthy, WJ
- Lewit, E
- Loft, S
- Burns, David
- Hammond, EC
- Henry, J
- Hughes, J
- Cohen, JB
- Davis, DL
- Giovino, Gary
- Glassman, AH
- Parmley, William
- Tyndale, R
- Yamazaki, H
- Tyndale, RF
- Hahn, A
- Armitage, A
- Kabat, GC
- Huber, GL
- Samet, Jonathan
- Sweanor, David
- Gori, GB
- Murray, RP
- Guerin, M
- Mattson, ME
- Henningfield, Jack
- Warner, KE
- Connolly, GN
- Zhu, BQ
- Glantz, SA
- Gray, Nigel
- Slade, John
- Appleton, Scott
- McClellan, Roger
- Pierce, JP
- Winn, DM
- Shy, CM
- Covey, LS
- Holt, PG
- Greenland, S
- Bohning, DE
- Cohen, D
- Thomas, WR
- Burns, D
- Ballin, Scott D
- Woosley, Raymond
- Connolly, Gregory
- Gust, SW
- Silverstein, B
- Severson, HH
- Kornitzer, M
- Grasso, P
- Corrigall, WA
- Freedman, R
- Dousset, N
- Mullen, Patricia Dolan
- Perez-Stable, EJ
- Thun, MJ
- Hughes, John
- Hatsukami, Dorothy
- McKinney, EF
- Rettig, R
- Stolerman, I
- Ashley, David
- Browne, CL
- Samet, J
- Yamamoto, T
- Mosberg, Arnold T
- Djordjevic, MV
- White, EL
- Glasgow, RE
- Norman, A
- Kanner, RE
- Martin, BR
- Reuter, Peter
- Carchman, Richard A
- Suber, Robert L
- Lesmes, GR
- Sobell, MB
- Joseph, AM
- Hurt, RD
- Shiffman, Saul
- Skoog, K
- Behm, FM
- Reznik, G
- Sampson, A
- Slade, J
- Prue, D
- Fung, YK
- Byrd, GD
- Lewis, JG
- Celermajer, DS
- Fu, Y
- Mauderly, JL
- Hjalmarson, A
- Blondal, T
- Wang, H
- Shopland, Don
- Reddy, S
- Pierce, John
- Houston, Thomas
- Schneider, NG
- Anthony, J
- Plant, M
- Wakefield, MA
- Evans, W
- Rajini, P
- Witschi, H
- Giovino, G
- Jaffe, Jerome H
- Cryer, PE
- Iauco, David
- Keast, D
- Brown, RA
- Fagerstrom, Karl
- Anda, RF
- Wang, T
- Johnson, R
- Kendrick, J
- Wilkenfeld, Judith
- Newman, RG
- Rennard, Stephen
- Tice, RR
- Forbes, A
- Djordjevic, M
- Coggins, Christopher
- Ross, HL
- Fiore, M
- Strandberg, TE
- Herbert, J
- Keenan, RM
- Dajani, RM
- Slovic, P
- Wogan, Gerald
- Perera, Frederica
- Pearson, Thomas
- Gazdar, Adi
- Furie, MB
- Nowak, J
- Moore, D
- Hutt, Peter Barton
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- Healy, DJ
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- Robinson, John H
- Balls, M
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- Stapleton, J
- Sobel, R
- Yost, BA
- Kandel, D
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Document Images
!
learing the Smoke
Assessing the Science Base for Tobacco Harm Reduction
Kathleen Stratton, Padma Shetty, Robert Wallace, and
Stuart Bondurant, Editors
Committee to Assess the Science Base tbr Tobacco Harm Reduction
Board on Health Promotion and Disease Prevention
INSTITUTE OF MEDICINE
NATIONAL ACADEMY PRESS
Washington, D.C.
325223758
CIca~'ing the Smoke: The ..%¢ienee ~a¢,c fot'Te,bacco H~rm Rcdt~¢llon
COMMITTEE TO ASSESS THE SCIENCE BASE
FOR TOBACCO HARM REDUCTION
STUART BONDURANT, M.D. (Chair), Professor, Department of Medicine, University. of
North Carolina, Chapel Hill
ROBERT WALLACE, M.D., M.Sc., (Vice-Chair) Professor, Department of Epidemiology and
Internal Medicine, University of Iowa Colleges of Public Health and Medicine
J. RICHARD CROUT, M.D., President, Crout Consulting
GARRET FITZGERALD, M.D., Professor and Chair. Department of Pharmacology,
University of Pennsylvania
ADI GAZDAR, M.D., Professor, Department of Pathology, University of Texas Southwestern
Medical Center
GARY GIOVINO, Ph.D., M.S., Senior Research Scientist, Roswell Park Cancer Institute
DOROTHY HATSUKAMI, Ph.D. Professor, Department of Psychiat~, and Pb.'ychology,
University of Minnesota
ROGENE F. HENDERSON, Ph.D., Senior Biochemist/Toxicologist, Lovelace Respiratory
Research Institute
PETER REUTER, Ph.D., Professor, School of Public Affairs and Department of Criminology,
University of MaD'land
DAVID J. RILEY, M.D., Professor of Medicine, Division of Pulmonary and Critical Care
Medicine, University of Medicine and Dentistry of New Jersey -Robert Wood Johnson
Medical School
PETER SHIELDS, M.D., Professor and Chief, Cancer Genetics and Epidemiology Program,
Lombardi Cancer Center, Georgetown University Medical Center
JAMES WlLLERSON, M.D., Professor and Chair of Internal Medicine, Lrniversity of Texas
Medical School
Health Promotion and Disease Prevention Board Liaison
KENNETH E. WARNER, Ph.D., Professor, Department of Health Management and Policy,
School of Public Health, University of Michigan
Neuroscience and Behavioral Health Board Liaison
RICHARD J. BONNIE, L.L.B., John S. Battle Professor of Law, Director, Institute of Law,
Psychiatry, and Public Policy, University of Virginia School of Law
Consultants
NEAL BENOWITZ, M.D., Professor and Chief of the Division of Clinical Pharmacology,
Departments of Medicine, Biopharmaceutical Sciences, and Psychiatry; University of
California, San Francisco
CHRISTOPHER LOFFREDO, M.S. Ph.D., Assistant Professor, Lombardi Cancer Center,
Georgetown University Medical Center
V
325223759
C'lca~'in_e lh¢ Smoke: The S¢ic~cc ~asc t'o~' Tob,l¢co H.~rm Reduction
Staff
KATHLEEN STRATTON, Ph.D., Study Director
PADMA SHETTY, M.D., Program Officer
ANN ST. CLAIRE, Senior Project Assistant
ROSE MARIE MARTINEZ, Se.D., Director, Bo~d on Health Promotion and Disease
Prevention
TERRY PELLMAR, Ph.D., Director, Division of Neuroscience and Behavioral Health
vi
325223760
The report was reviewed by individuals chosen for their diverse perspectives and
technical expertise in accordance with procedures approved by the National Research
Council's Report Review Committee. The purpose of this independent review is to
provide candid and critical comments to assist the authors and the Institute of Medicine in
making the published report as sound as possible and to ensure that the report meets
institutional s~andards for objectivity, evidence, and responsiveness to the stud)" charge.
The content of the review comments and the draft manuscript remain confidential to
protect the integri .ty of the deliberative process. The committee wishes to thank the
following individuals for their participation in the report review process:
Daniel Azarnoff, D.L. Azamoff Associates
Alfred Fishman, University of Pennsylvania
Margaret Gilhooley, Seton Hall University
Jack Henningfield, Pinney Associates
Peter Barton Hurt, Covington and Burling
Roger McClellan. Chemical Industry Institute of Toxicology, President Emeritus
Patricia Dolan Mullen, University of Texas
Peter Nowell, University of Permsylvania
William Parmley, University. of California, San Francisco
Thomas Pearson, University of Rochester
Irrederica Perera, Columbia University
John Pierce, University of California, San Diego
Stephen Rennard, Urtiversity of Nebraska
Joseph Rodricks, The Life Sciences Consultancy
Jonathan Samet, Johns Hopkins University
Thomas Schelling, University of Maryland
John Slade, University of Medicine and Dentistry of New Jersey-Robert Wood
Johnson Medical School
Judith Wilkenfeld, Campaign for Tobacco Free Kids
Gerald Wogan, Massachusetts Institute of Technology
Raymond Woosley, Georgetov~7~ University
Although the reviewers listed above have provided many constructive comments
and suggestions, they xvere not asked to endorse the conclusions or recommendations nor
did they see the final draft of the report before its release. The review of this report was
overseen by David Challoner, (review monitor) University of Florida and Hugh Tilson,
(review coordinator) University of North Carolina. Appointed by the National Research
Council and Institute of Medicine, they were responsible for making certain lhat an
independent examination of this report was carried out in accordance with institutional
procedures and that all review comments were carefully considered. Responsibility for
the final content of this report rests entirely with the authoring committee and the
institution.
vii
325223761
x Clear#Tg the
Smoke
there impartial and thorough assessment of the risk associated with new tobacco products rela-
tive to the risk of abstinence or the risk of other tobacco products prior to marketing. Unlike new
tobacco products, nicotine replacement products are subject to full disclosure of content, rigorous
testing, and the regulation of marketing claims by the of the Food and Drug Administration.
In addition to tobacco smoke, other forms of tobacco such as cigars, che~Sng tobacco, and
snuff are also vectors of nicotine addiction and often have their own sets of serious toxic conse-
quences.
The latent period between beginning exposure to tobacco and the development of most of the
major adverse consequences is so long that empirical, direct evidence (assessment of immediate
and long-term toxicity of individual tobacco products in humans) that one tobacco product is less
harmfid than another will rarely be available in time to be a basis for informing users. In the ab-
sence of direct evidence, conflicting claims of the degree of harm reduction are likely and in-
~brmed usage decisions by smokers and nonsmokers will be difficult.
No one knows the dose-response relations, the specific toxins, the pathogenic mechanisms,
or the interrelationship between the many components of tobacco smoke with enough precision
to make scientifically reliable quantitative judgments about the risk or actual harm reduction as-
sociated with use of any tobacco product. Since we do not know which of mmly toxins may be
the cause of specific harmful effects, we can only infer but we cannot know the health effects of
the elimination of any one or several tobacco components. Further, we are just b~ginnhng to
identify and understand the genetic basis and other causes of the differences in susceptibility, to
toxic effects among groups or individuals that largely determine the response of an individual to
a toxin.
Nonetheless, it is reasonable to expect that some of the new products will reduce exposure to
tobacco toxins and possibly reduce harm to some users and to others who are exposed to them. It
is, therefore, urgent and important that the assessment of exposure to tobacco toxins resulting
from the use of modified tobacco products or drugs be based on the best available evidence,
made by the most qualified judges, and communicated to policy makers and the public com-
pletely and honestly.
There is little direct evidence available to serve as a basis for judgment as to the potential
for
harm reduction of specific new tobacco and pharmaceutical products. Therefore. an3' conclu-
sions as to the relative harm of these products must necessarily be inferred from a base of indi-
rect knowledge. The continuing introduction of new tobacco products with implicit or explicit
claims of risk or harm reduction makes it important and urgent that the capacity, for the best pos-
sible scientific assessment of these claims be put in place.
Since even the availability of harm reduction products may deter some from IbIlowing the
healthier course of abstinence or cessation, assessment of health claims should be based on an
estimate of the effect of the product on the prevalence of smoking in the population, as well as
the effect on the health risk to the individual smoker.
The most reliable scientific interpretation of necessarily incomplete indirect evidence comes
when individuals who are experts in the relative fields, are not biased, and are free of conflict of
interest form a consensual judgment. Such a judgment based on evidence of high quality should
be a requirement for a conclusion that the use of a product is in fact associated with decreased
exposure to toxins and that the decreased exposure is likely to be associated with less harmful
outcomes.
32fi223762
• " Clearing the Stool;c: The Science [ta¢,c for Tobacco Hat'tll Reductiotl
Preface
X i
Further, since these judgments of risk will necessarily be inferential because they are based
on indirect and inconclusive evidence, some form of postmarketing surveillance of each product
is important.
The charge to the committee is to address the science base for harm reduction from tobacco.
The committee concluded early in its deliberations that the science base for harm reduction will
evolve over time. There will inevitably be important interactions between the types of products
that are developed and the science base. There will also be interactions between any regulatory.
process and the science base (the science base will influence regulation, and regulation will focus
pertinent science) and, obviously, between regulations and products. For these reasons, the
committee realized that the science base for harm reduction can be usefully considered only in
the context of some sense of the types of specific products and of the consequences of regulation.
Accordingly~ portions of this report address both general categories of potential harm reduction
products and regulatory considerations.
It is the strong sense of the committee that claims of less harm or risk associated with the use
of tobacco products or drugs should be available--but only if four conditions are met: (I) There
should be strong and widely available programs designed to avoid initiation and to achieve absti-
nence; (2) There should be premarketing evidence satisfactory to a group of disinterested experts
that--as the product will actually be used by consumers--there is less exposure to toxic agents
without coincidental increase in harm to the individual from other smoke components or to the
population from encouraging initiation or continuation of smoking, the burden of proof of asser-
tions of harm reduction should rest entirely with those making the assertion: (3) The public
should be fully informed of the strength of the claims as assessed by an independent panel of ex-
perts. (4) There should be an effective surveillance system in place to determine short-term be-
havioral and the long-term health consequences of the use of the new products.
The committee wishes to express its great appreciation to the many individuals, listed in Ap-
pendix B, xvho contributed generously mad substantially to it deliberations. Representatives of
many health agencies as well as tobacco interests responded thoughtfully and extensively to the
committee's questions.
Dr. Kathleen Stratton contributed perspective, insight, meticulous attention to detail, and es-
sential oversight to the work and report. This report would not be possible ~dthout her substantial
and important contributions.
Dr. Padma Sherry assumed responsibility for blocks of the report, and both the full report and
many specific parts are testimony to her analytic, organizational, and expressive proficiency.
Ann St. Claire organized the arrangements for the work of the committee with great f'messe and
also made useful contributions to the anal3¢ical work of the committee. Every member of the
committee is deeply appreciative of the work of Dr. Stratton: Dr. Shetty, and Ms. St. Claire.
Stuart Bondurant
Chair
325223763
Ctza~'in$ the Smokc: The S¢ic~}¢c lqa~c ft'w Tobacco Harm Rcduction
Clearing the Smoke
Assessing the Science Base for Tobacco Harm
Reduction
Kathleen Stratton, Padma Shetty, Robert Wallace, and
Stuart Bondurant, Editors
Committee to Assess the Science Base for Tobacco Harm Reduction
Board on Health Promotion and Disease Prevention
INSTITUTE OF MEDICINE
NATIONAL ACADEMY PRESS
Washington, D.C.
325223764
('[caHng ~1~c S~nokc: The S¢ic,~cc Base r'o,'Toba¢¢o Harm Rc.duction
NATIONAL ACADEMY PRESS * 2101 Constitution Avenue, N.W. • ~Vashington, DC 20418
NOTICE: The project that is the subject of this report was approved by the Governing Board of the
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Support for this project was provided by the Food and Drug Administration prior to the March
2000
decision by the Supreme Court denying FDA comprehensive authority over tobacco products. The views
presented in this report are those of the Institute of Medicine Committee to Assess the Science Base
for
Tobacco Harm Reduction and are not necessarily those of the funding agencies.
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325223765
Clcarh~g the Smoke: Th," Science F~o~¢ t'o~' Tobacco H.11'tT~ R;.(tL~C'tion
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325223766
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Clearing the Smoke: The Science Base for Tobacco Harm Reduction
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Institute of Medicine (mo~re tit_los f~'om~10.~)
Related Books
Front Matter
Contents
S_um_ma~j
Introduction
P rj _nc. ip!e so f_Har~_ ..R_eduction~
Historical P~r~pe_cti_ve a_~nd_ L_e_ss.0_OS_ _Lea._med
Prod UCt_S, [or ~Tqb_~_c_qg__E xp_q_s ~_e__R_ e_duc_t ion
The Science Base
Su _ry_eil_la_n.c_e_ fpr_t_h_e_Health and _B_eha_vi_o_r_a_l.
~o_..n_se_qu__e_nces of Harm Re_d._u_qtio_~
Implementation of a Science-Based Policy of
Harm Reduction
Principal__Co_0c_!u_sio_ns
Nj_coti..n_e Pharmacology
Tob_a_cc o S_m_ 9.k_e .~t _nd .T_o_ x_i_c9 !_o_ g y
E~p_os.u_re.~n_d Biom_ar_ k_e~ A__ss_e_s~_men_t_ .in
Humans
Cancer
Cardiovascular Disease
No .np_ egplastic Res_p_i_rat_o_ry__ D i seas e s
Re_pr0d_uc_tiye_an~ Dev_e_lopmental Effects
Other Health Effects
Append_ixA: _Prese nta_tio_n_s _a~3__d_.S_u_b_m_ iSS_ !9_ns
App_e_n_dix B: Com_m~ttee__B_i_0gr_a_p__h!qa_l
Sketches
Appendix C: Time. Line_of__T_obocc_o Event_s
i-xii
xiii-xvi
1-16
17-30
31-48
49-68
69-116
117-146
147-164
165-188
189-198
199~28
229-248
249-292
293-380
381-404
405-440
441-454
455-474
475-478
479-484
485-498
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