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Suggested Citation:"Front Matter." Institute of Medicine. 2012. Scientific Standards for Studies on Modified Risk Tobacco Products. Washington, DC: The National Academies Press. doi: 10.17226/13294.
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Scientific Standards
FOR STUDIES ON
Modified Risk Tobacco Products

Committee on Scientific Standards for Studies on
Modified Risk Tobacco Products

Board on Population Health and Public Health Practice

INSTITUTE OF MEDICINE
OF THE NATIONAL ACADEMIES

THE NATIONAL ACADEMIES PRESS

Washington, D.C.

www.nap.edu

Suggested Citation:"Front Matter." Institute of Medicine. 2012. Scientific Standards for Studies on Modified Risk Tobacco Products. Washington, DC: The National Academies Press. doi: 10.17226/13294.
×

THE NATIONAL ACADEMIES PRESS 500 Fifth Street, NW Washington, DC 20001

NOTICE: The project that is the subject of this report was approved by the Governing Board of the National Research Council, whose members are drawn from the councils of the National Academy of Sciences, the National Academy of Engineering, and the Institute of Medicine. The members of the committee responsible for the report were chosen for their special competences and with regard for appropriate balance.

This study was supported by Contract No. HHSF22301011T, Task Order #17 between the National Academy of Sciences and the Food and Drug Administration of the U.S. Department of Health and Human Services. Any opinions, findings, conclusions, or recommendations expressed in this publication are those of the author(s) and do not necessarily reflect the view of the organizations or agencies that provided support for this project.

International Standard Book Number-13: 978-0-309-22398-0
International Standard Book Number-10: 0-309-22398-9

Additional copies of this report are available from the National Academies Press, 500 Fifth Street, NW, Keck 360, Washington, DC 20001; (800) 624-6242 or (202) 334-3313; http://www.nap.edu.

For more information about the Institute of Medicine, visit the IOM home page at: www.iom.edu.

Copyright 2012 by the National Academy of Sciences. All rights reserved.

Printed in the United States of America

The serpent has been a symbol of long life, healing, and knowledge among almost all cultures and religions since the beginning of recorded history. The serpent adopted as a logotype by the Institute of Medicine is a relief carving from ancient Greece, now held by the Staatliche Museen in Berlin.

Suggested citation: IOM (Institute of Medicine). 2012. Scientific Standards for Studies on Modified Risk Tobacco Products. Washington, DC: The National Academies Press.

Suggested Citation:"Front Matter." Institute of Medicine. 2012. Scientific Standards for Studies on Modified Risk Tobacco Products. Washington, DC: The National Academies Press. doi: 10.17226/13294.
×

Knowing is not enough; we must apply.
Willing is not enough; we must do.

—Goethe

image

INSTITITE OF MEDICINE
OF THE NATIONAL ACADEMIES

Advising the Nation. Improving Health.

Suggested Citation:"Front Matter." Institute of Medicine. 2012. Scientific Standards for Studies on Modified Risk Tobacco Products. Washington, DC: The National Academies Press. doi: 10.17226/13294.
×

THE NATIONAL ACADEMIES

Advisers to the Nation on Science, Engineering, and Medicine

The National Academy of Sciences is a private, nonprofit, self-perpetuating society of distinguished scholars engaged in scientific and engineering research, dedicated to the furtherance of science and technology and to their use for the general welfare. Upon the authority of the charter granted to it by the Congress in 1863, the Academy has a mandate that requires it to advise the federal government on scientific and technical matters. Dr. Ralph J. Cicerone is president of the National Academy of Sciences.

The National Academy of Engineering was established in 1964, under the charter of the National Academy of Sciences, as a parallel organization of outstanding engineers. It is autonomous in its administration and in the selection of its members, sharing with the National Academy of Sciences the responsibility for advising the federal government. The National Academy of Engineering also sponsors engineering programs aimed at meeting national needs, encourages education and research, and recognizes the superior achievements of engineers. Dr. Charles M. Vest is president of the National Academy of Engineering.

The Institute of Medicine was established in 1970 by the National Academy of Sciences to secure the services of eminent members of appropriate professions in the examination of policy matters pertaining to the health of the public. The Institute acts under the responsibility given to the National Academy of Sciences by its congressional charter to be an adviser to the federal government and, upon its own initiative, to identify issues of medical care, research, and education. Dr. Harvey V. Fineberg is president of the Institute of Medicine.

The National Research Council was organized by the National Academy of Sciences in 1916 to associate the broad community of science and technology with the Academy’s purposes of furthering knowledge and advising the federal government. Functioning in accordance with general policies determined by the Academy, the Council has become the principal operating agency of both the National Academy of Sciences and the National Academy of Engineering in providing services to the government, the public, and the scientific and engineering communities. The Council is administered jointly by both Academies and the Institute of Medicine. Dr. Ralph J. Cicerone and Dr. Charles M. Vest are chair and vice chair, respectively, of the National Research Council.

www.national-academies.org

Suggested Citation:"Front Matter." Institute of Medicine. 2012. Scientific Standards for Studies on Modified Risk Tobacco Products. Washington, DC: The National Academies Press. doi: 10.17226/13294.
×

COMMITTEE ON SCIENTIFIC STANDARDS FOR STUDIES ON MODIFIED RISK TOBACCO PRODUCTS

Jane E. Henney (Chair), Professor of Medicine and Public Health Sciences, University of Cincinnati, Ohio

Timothy B. Baker, Professor of Medicine and Associate Director, Center for Tobacco Research and Intervention, University of Wisconsin, Madison

Rebecca Bascom, Professor of Medicine, Milton S. Hershey Medical Center, The Pennsylvania State University, Hershey

Shyam Biswal, Professor, Department of Environmental Health Sciences, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland

Daniel Carpenter, Professor of Government, Center for Government and International Studies, Harvard University, Boston, Massachusetts

Constantine Gatsonis, Henry Ledyard Goddard University Professor and Chair, Department of Biostatistics, Brown University, Providence, Rhode Island

Gary H. Gibbons,1 Professor of Medicine and Director, Cardiovascular Research Institute, Morehouse School of Medicine, Atlanta, Georgia

Bonnie L. Halpern-Felsher, Professor, Department of Pediatrics, Division of Adolescent Medicine, University of California, San Francisco

Stephen S. Hecht, Wallin Professor of Cancer Prevention, Department of Laboratory Medicine and Pathology, Masonic Cancer Center, University of Minnesota, Minneapolis

Peter K. Honig, Head, Global Regulatory Affairs, AstraZeneca, Wilmington, Delaware

Richard J. O’Connor, Associate Member, Department of Health Behavior, Division of Cancer Prevention and Population Sciences, Roswell Park Cancer Institute, Buffalo, New York

Joel L. Schwartz, Professor, Oral Medicine and Pathology, Colleges of Dentistry and Medicine, University of Illinois at Chicago

Donna-Bea Tillman, Director of Regulations and Policy, Microsoft Corporation, Health Solutions Group, Chevy Chase, Maryland

Alastair J. J. Wood, Managing Director, Symphony Capitol LLC, New York, New York

Anna H. Wu,2 Professor, Preventive Medicine, Division of Epidemiology, University of Southern California, Los Angeles

_______________

1 Committee member resigned October 2011.

2 Committee member resigned June 2011.

Suggested Citation:"Front Matter." Institute of Medicine. 2012. Scientific Standards for Studies on Modified Risk Tobacco Products. Washington, DC: The National Academies Press. doi: 10.17226/13294.
×

Study Staff

Kathleen Stratton, Study Director (through September 2011)

Joel Wu, Study Director (from September 2011)

Michelle C. Catlin, Senior Program Officer (from September 2011)

Erin Rusch, Research Associate (from September 2011)

Hannan Braun, Research Assistant

Malcolm Biles, Senior Program Assistant

Rose Marie Martinez, Director, Board on Population Health and Public Health Practice

Consultants

Suchitra Krishnan-Sarin, Associate Professor of Psychiatry and Vice Chair, Human Investigations Committee, Yale University School of Medicine

Holly E. R. Morrell, Assistant Professor, Department of Psychology, Loma Linda University

Gary Stoner, Professor of Medicine, Department of Medicine, Medical College of Wisconsin

Wendy Theobald, Researcher, Center for Tobacco Research and Intervention, University of Wisconsin Medical School

Robert B. Wallace, Irene Ensminger Stecher Professor of Epidemiology and Internal Medicine, Department of Epidemiology, College of Public Health, The University of Iowa

Suggested Citation:"Front Matter." Institute of Medicine. 2012. Scientific Standards for Studies on Modified Risk Tobacco Products. Washington, DC: The National Academies Press. doi: 10.17226/13294.
×

Reviewers

This report has been reviewed in draft form 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 that will assist the institution in making its published report as sound as possible and to ensure that the report meets institutional standards for objectivity, evidence, and responsiveness to the study charge. The review comments and draft manuscript remain confidential to protect the integrity of the deliberative process. We wish to thank the following individuals for their review of this report:

Linda S. Birnbaum, National Institute of Environmental Health Sciences

Richard J. Bonnie, University of Virginia

David B. Coultas, The University of Texas Health Science Center at Tyler

Louis Anthony Cox, Jr., Cox Associates

Sean P. David, Stanford University School of Medicine

Jonathan Foulds, Penn State College of Medicine

Mitchell H. Gail, National Cancer Institute

John R. Hughes, University of Vermont College of Medicine

Donald S. Kenkel, Cornell University

Caryn Lerman, University of Pennsylvania

Dean Lillard, Cornell University

Ana Navas-Acien, Johns Hopkins Bloomberg School of Public Health

Page viii Cite
Suggested Citation:"Front Matter." Institute of Medicine. 2012. Scientific Standards for Studies on Modified Risk Tobacco Products. Washington, DC: The National Academies Press. doi: 10.17226/13294.
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Dan Romer, The Annenberg Public Policy Center of the University of Pennsylvania

Barry Sickels, AstraZeneca

Brian L. Strom, Perelman School of Medicine at the University of Pennsylvania

Clifford H. Watson, Centers for Disease Control and Prevention

Although the reviewers listed above have provided many constructive comments and suggestions, they were 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 May R. Berenbaum, University of Illinois, and Robert S. Lawrence, Johns Hopkins Bloomberg School of Public Health. Appointed by the National Research Council and Institute of Medicine, they were responsible for making certain that 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.

Suggested Citation:"Front Matter." Institute of Medicine. 2012. Scientific Standards for Studies on Modified Risk Tobacco Products. Washington, DC: The National Academies Press. doi: 10.17226/13294.
×

Preface

Tobacco use remains the leading cause of preventable morbidity and mortality in the United States. While the adverse health effects of tobacco use are well established in the scientific literature, an understanding of the science is not required to appreciate the human cost; every day, people see close friends and family suffer with the consequences of tobacco use. Every day, cigarette smokers try to quit, and yet, the vast majority of them will fail. An estimated 70 percent of smokers want to quit completely, and while 45 percent attempt to quit each year, only 6 percent of smokers are able to successfully quit.

Instead of quitting, many cigarette smokers have sought a product with less risk, and for decades, the tobacco industry has purposefully misled the public into believing that there have been safer alternatives. The most prominent example is the “light” cigarette—a product implied to be safer, which in fact, when used, was as hazardous as “regular” cigarettes. The prospect of a less hazardous tobacco product is not in and of itself problematic. The fundamental issue is that if a product is going to be marketed as being “safer,” then the claim must be true.

Section 911 of the Family Smoking Prevention and Tobacco Control Act of 2009 directly addresses the problem of false and unfounded claims for modified risk tobacco products (MRTPs). The law remains open to the possibility that less hazardous products that reduce harm to public health may enter the market, but it gives the government the authority and the power to assure that they are actually reducing risk and harm. The law also directed the U.S. Food and Drug Administration (FDA) to develop, in

Suggested Citation:"Front Matter." Institute of Medicine. 2012. Scientific Standards for Studies on Modified Risk Tobacco Products. Washington, DC: The National Academies Press. doi: 10.17226/13294.
×

consultation with the Institute of Medicine (IOM), regulations and guidance on the design and conduct of scientific studies of MRTPs, which was the task of the committee.

Regulating tobacco products creates unique challenges. Unlike most products regulated by the FDA, tobacco is inherently hazardous and offers primarily risks rather than any significant physiological benefit to the user’s health. Recognizing this, the law provides a public health standard and additional requirements of these products that must be considered as the FDA regulates these products. First, the law creates a public health standard that requires the FDA to evaluate the effect of the MRTP on not only users of the product, but also nonusers and the entire population as a whole. Second, the law requires postmarket observational studies of the MRTPs as a condition of approval, and also requires the annual submission of data about the MRTPs to the FDA. Finally, the law sets expiration dates on the orders to market the MRTPs. In addition, the FDA can revoke an order for any failure to comply with regulatory requirements or if there is evidence that the product is in fact harmful to public health.

The evaluation of the effect of MRTPs on public health will require a wide range of evidence and therefore will require many different types of study designs, including studies of the composition of MRTPs and studies of human exposure, human health effects, the likelihood of addiction and abuse, and the perception and understanding of the product by the public. Furthermore, the evidence must be able to reliably support predictions about the effect of marketing the product on public health, and therefore these studies must be properly designed and rigorously conducted. Study designs will need to include all relevant populations including populations at a high risk for tobacco use. Study designs must be able to support not only inferences about the mechanisms of the products effects, but also predictions about the products’ effects in the real world.

Also, relevant to the committee’s deliberations as it considered the conduct of studies is the history of the tobacco industry’s past behavior. The tobacco industry has a long and well-documented history of illegal and improper conduct, and its practices have only recently been regulated. Because of the health impact of its products and the opaque practices that have been engaged by the tobacco industry, many academic institutions and their faculty that would normally be involved in a product’s evaluation have been separated from conducting research related to tobacco products for many years. Thus, the committee concluded that the tobacco industry currently lacks not only the trustworthiness, but also the expertise, infrastructure, and other resources needed to independently produce the scientific evidence necessary to meet the public health standards set by the law. In the report, the committee explores the possibility

Suggested Citation:"Front Matter." Institute of Medicine. 2012. Scientific Standards for Studies on Modified Risk Tobacco Products. Washington, DC: The National Academies Press. doi: 10.17226/13294.
×

of new governance mechanisms to address this problem, including the potential creation of a third-party governance entity. The committee does recognize that there are MRTPs that may not be developed by the tobacco industry and thus believes the need for third-party governance may not be applicable in all cases.

Overall, the committee’s goal was to develop enduring guidelines and considerations for the production of credible and comprehensive evidence of the effects of MRTPs. The committee emphasized that the principle of public disclosure, which adds the sunshine of openness and transparency, must be applied to the entire process of product development. It is hoped that this report will provide guidance not only to the FDA but also to all stakeholders (the tobacco industry, academic researchers, and journal editors, etc.) on how the important work of evaluating these products can move ahead.

This committee has volunteered a great deal of time and energy into completing a remarkably complex task, and for that I am very appreciative. I thank its members for their collective and individual efforts. I would also like to extend my own and the committee’s gratitude to Suchitra Krishnan-Sarin, Holly E. Morrell, Gary Stoner, Wendy Theobald, and Robert B. Wallace for their assistance and expertise as external consultants. On behalf of the committee, appreciation is also extended to each who provided information, data, or even an informed opinion during open sessions or by mail. Finally, the committee and I would like to thank the IOM staff for their hard work and diligence: Kathleen Stratton, Joel Wu, Michelle C. Catlin, Erin Rusch, Hannan Braun, Malcolm Biles, and Rose Marie Martinez.

Jane E. Henney, Chair
Committee on Scientific Standards for
Studies on Modified Risk Tobacco Products

Suggested Citation:"Front Matter." Institute of Medicine. 2012. Scientific Standards for Studies on Modified Risk Tobacco Products. Washington, DC: The National Academies Press. doi: 10.17226/13294.
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Acronyms and Abbreviations

1-HOP 1-hydroxypyrene
3HdT tritiated thymidine
4-NQO 4-Nitroquinoline 1-oxide
   
ARISE Associates for Research into the Science of Enjoyment
   
BaP benzo[a]pyrene
bp base pair
BrdU 5’-bromodeoxy-uridine
   
CDC Centers for Disease Control and Prevention
CER comparative effectiveness research
CFR Code of Federal Regulations
CIAR Center for Indoor Air Research
CISNET Cancer Intervention and Surveillance Modeling Network
CO carbon monoxide
CONSORT Consolidated Standards of Reporting Trials
COPD chronic obstructive pulmonary disease
CRP C-reactive protein
CS cigarette smoke
CSC cigarette smoke condensate
CSE cigarette smoke extract
CTP Center for Tobacco Products
CTR Council for Tobacco Research
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DAPI 4’,6-diamidino-2-phenylindole
DMBA dimethylbenz[a] anthracene
DMC data monitoring committee
DMEM Dulbecco’s Modified Eagle Medium
DMSO dimethyl sulfoxide
DSMB data and safety monitoring board
DSM-IV Diagnostic and Statistical Manual of Mental Disorders, 4th Edition
   
ELISA enzyme-linked immunosorbent assay
EPA Environmental Protection Agency
   
FD&C Act Food, Drug, and Cosmetic Act
FDA Food and Drug Administration
FDAAA Food and Drug Administration Amendments Act
FSPTCA Family Smoking Prevention and Tobacco Control Act of 2009
FTC Federal Trade Commission
   
GC-MS gas chromatography-mass spectrometry
GC-MS/MS gas chromatography-tandem mass spectrometry
   
H1N1 Influenza A
HBMA 4-hydroxybut-2-yl mercapturic acid
HBSS Hanks buffered salt solution
HEI Health Effects Institute
HEMA 2-hydroxyethyl mercapturic acid
HHS U.S. Department of Health and Human Services
HONC Hooked on Nicotine Checklist
HPMA 3-hydroxypropyl mercapturic acid
hr hour
HSV-1 herpes simplex virus 1
   
IAPS International Affective Picture System
ICAM-1 inter-cellular adhesion molecule-1
IL-8 interleukin 8
INS-GAS insulin-gastrin
IOM Institute of Medicine
IRB institutional review board
IVR interactive voice response
   
LC-MS/MS liquid chromatography-tandem mass spectrometry
Suggested Citation:"Front Matter." Institute of Medicine. 2012. Scientific Standards for Studies on Modified Risk Tobacco Products. Washington, DC: The National Academies Press. doi: 10.17226/13294.
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MAPK mitogen-activated protein kinase
MCA methylcoanthrene
MCP-1 monocyte chemotactic protein-1
MHBMA 1-hydroxy-2-(N-acetylcysteinyl)-3-butene and 1-(N-acetylcysteinyl)-2-hydroxy-3-butene
mRNA messenger RNA
MRTP modified risk tobacco product
MSA Master Settlement Agreement
MTS 3-(4,5-dimethylthiazol-2-yl)-5-(3-carboxymethoxyphenyl)-2-(4-sulfophenyl)-2H-tetrazolium
MTT 3-(4,5-Dimethylthiazol-2-yl)-2,5-Diphenyltetrazolium Bromide
   
NACDA National Advisory Council on Drug Abuse
NCI National Cancer Institute
NF-kB nuclear factor kappaB
NG not given
NIDA National Institute on Drug Abuse
NNAL 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol
NNK nicotine-derived nitrosamine ketone
NNN N-nitrosonornicotine
NRC National Research Council
NRT nicotine replacement therapy
   
OSMB observational study monitoring board
OTC over-the-counter
   
PAMP pathogen-associated molecular patterns
PBS phosphate buffered saline
PCR polymerase chain reaction
poly(I:C) Polyinosinic:polycytidylic acid
ppm parts per million
PREP potential reduced-exposure product
   
RCT randomized controlled trial
RFA requests for application
RICO Racketeer Influenced and Corrupt Organizations
RNS reactive nitrogen species
ROS reactive oxygen species
RUF Reagan-Udall Foundation
   
SPMA S-phenylmercapturic acid
ST smokeless tobacco
Suggested Citation:"Front Matter." Institute of Medicine. 2012. Scientific Standards for Studies on Modified Risk Tobacco Products. Washington, DC: The National Academies Press. doi: 10.17226/13294.
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STE smokeless tobacco extract
STROBE Strengthening the Reporting of Observational Studies in Epidemiology
   
TI Tobacco Institute
TRADD tumor necrosis factor receptor type 1-associated death domain protein
TRGE tobacco research governance entity
TSNA tobacco-specific N-nitrosamines
TUNEL terminal deoxynucleotidyl transferase dUTP nick end labeling
   
VCAM-1 vascular cell adhesion molecule 1
VEGF-A vascular endothelial growth factor A
   
wk week
   
yrs years
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Smoking-related diseases kill more Americans than alcohol, illegal drugs, murder and suicide combined. The passage of the Family Smoking Prevention and Tobacco Control Act of 2009 gave the FDA authority to regulate "modified risk tobacco products" (MRTPs), tobacco products that are either designed or advertised to reduce harm or the risk of tobacco-related disease. MRTPs must submit to the FDA scientific evidence to demonstrate the product has the potential to reduce tobacco related harms as compared to conventional tobacco products. The IOM identifies minimum standards for scientific studies that an applicant would need to complete to obtain an order to market the product from the FDA.

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