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      Tobacco Company Efforts to Influence the Food and Drug Administration-Commissioned Institute of Medicine Report Clearing the Smoke: An Analysis of Documents Released through Litigation

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      PLoS Medicine

      Public Library of Science

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          Abstract

          Stanton Glantz and colleagues investigate efforts by tobacco companies to influence Clearing the Smoke, a 2001 Institute of Medicine report on harm reduction tobacco products.

          Please see later in the article for the Editors' Summary

          Abstract

          Background

          Spurred by the creation of potential modified risk tobacco products, the US Food and Drug Administration (FDA) commissioned the Institute of Medicine (IOM) to assess the science base for tobacco “harm reduction,” leading to the 2001 IOM report Clearing the Smoke. The objective of this study was to determine how the tobacco industry organized to try to influence the IOM committee that prepared the report.

          Methods and Findings

          We analyzed previously secret tobacco industry documents in the University of California, San Francisco Legacy Tobacco Documents Library, and IOM public access files. (A limitation of this method includes the fact that the tobacco companies have withheld some possibly relevant documents.) Tobacco companies considered the IOM report to have high-stakes regulatory implications. They developed and implemented strategies with consulting and legal firms to access the IOM proceedings. When the IOM study staff invited the companies to provide information on exposure and disease markers, clinical trial design for safety and efficacy, and implications for initiation and cessation, tobacco company lawyers, consultants, and in-house regulatory staff shaped presentations from company scientists. Although the available evidence does not permit drawing cause-and-effect conclusions, and the IOM may have come to the same conclusions without the influence of the tobacco industry, the companies were pleased with the final report, particularly the recommendations for a tiered claims system (with separate tiers for exposure and risk, which they believed would ease the process of qualifying for a claim) and license to sell products comparable to existing conventional cigarettes (“substantial equivalence”) without prior regulatory approval. Some principles from the IOM report, including elements of the substantial equivalence recommendation, appear in the 2009 Family Smoking Prevention and Tobacco Control Act.

          Conclusions

          Tobacco companies strategically interacted with the IOM to win several favored scientific and regulatory recommendations.

          Please see later in the article for the Editors' Summary

          Editors' Summary

          Background

          Up to half of tobacco users will die of cancer, lung disease, heart disease, stroke, or another tobacco-related disease. Cigarettes and other tobacco products cause disease because they expose their users to nicotine and numerous other toxic chemicals. Tobacco companies have been working to develop a “safe” cigarette for more than half a century. Initially, their attention focused on cigarettes that produced lower tar and nicotine yields in machine-smoking tests. These products were perceived as “safer” products by the public and scientists for many years, but it is now known that the use of low-yield cigarettes can actually expose smokers to higher levels of toxins than standard cigarettes. More recently, the tobacco companies have developed other products (for example, products that heat aerosols of nicotine, rather than burning the tobacco) that claim to reduce harm and the risk of tobacco-related disease, but they can only market these modified risk tobacco products in the US after obtaining Food and Drug Administration (FDA) approval. In 1999, the FDA commissioned the US Institute of Medicine (IOM, an influential source of independent expert advice on medical issues) to assess the science base for tobacco “harm reduction.” In 2001, the IOM published its report Clearing the Smoke: Assessing the Science Base for Tobacco Harm and Reduction, which, although controversial, set the tone for the development and regulation of tobacco products in the US, particularly those claiming to be less dangerous, in subsequent years.

          Why Was This Study Done?

          Tobacco companies have a long history of working to shape scientific discussions and agendas. For example, they have produced research results designed to “create controversy” about the dangers of smoking and secondhand smoke. In this study, the researchers investigate how tobacco companies organized to try to influence the IOM committee that prepared the Clearing the Smoke report on modified risk tobacco products by analyzing tobacco industry and IOM documents.

          What Did the Researchers Do and Find?

          The researchers searched the Legacy Tobacco Documents Library (a collection of internal tobacco industry documents released as a result of US litigation cases) for documents outlining how tobacco companies tried to influence the IOM Committee to Assess the Science Base for Tobacco Harm Reduction and created a timeline of events from the 1,000 or so documents they retrieved. They confirmed and supplemented this timeline using information in 80 files that detailed written interactions between the tobacco companies and the IOM committee, which they obtained through a public records access request. Analysis of these documents indicates that the tobacco companies considered the IOM report to have important regulatory implications, that they developed and implemented strategies with consulting and legal firms to access the IOM proceedings, and that tobacco company lawyers, consultants, and regulatory staff shaped presentations to the IOM committee by company scientists on various aspects of tobacco harm reduction products. The analysis also shows that tobacco companies were pleased with the final report, particularly its recommendation that tobacco products can be marketed with exposure or risk reduction claims provided the products substantially reduce exposure and provided the behavioral and health consequences of these products are determined in post-marketing surveillance and epidemiological studies (“tiered testing”) and its recommendation that, provided no claim of reduced exposure or risk is made, new products comparable to existing conventional cigarettes (“substantial equivalence”) can be marketed without prior regulatory approval.

          What Do These Findings Mean?

          These findings suggest that tobacco companies used their legal and regulatory staff to access the IOM committee that advised the FDA on modified risk tobacco products and that they used this access to deliver specific, carefully formulated messages designed to serve their business interests. Although these findings provide no evidence that the efforts of tobacco companies influenced the IOM committee in any way, they show that the companies were satisfied with the final IOM report and its recommendations, some of which have policy implications that continue to reverberate today. The researchers therefore call for the FDA and other regulatory bodies to remember that they are dealing with companies with a long history of intentionally misleading the public when assessing the information presented by tobacco companies as part of the regulatory process and to actively protect their public-health policies from the commercial interests of the tobacco industry.

          Additional Information

          Please access these Web sites via the online version of this summary at http://dx.doi.org/10.1371/journal.pmed.1001450.

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          Most cited references 24

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          Tobacco industry documents: treasure trove or quagmire?

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            Tobacco industry efforts subverting International Agency for Research on Cancer's second-hand smoke study.

            Scientific reports on second-hand smoke have stimulated legislation on clean indoor air in the USA, but less so in Europe. Recently, the largest European study, by the International Agency for Research on Cancer (IARC), demonstrated a 16% increase in the point estimate of risk in lung cancer for nonsmokers, a result consistent with earlier studies. However, the study was described by newspapers and the tobacco industry as demonstrating no increase in risk. To understand the tobacco industry's strategy on the IARC study we analysed industry documents released in US litigation and interviewed IARC investigators. The Philip Morris tobacco company feared that the study (and a possible IARC monograph on second-hand smoke) would lead to increased restrictions in Europe so they spearheaded an inter-industry, three-prong strategy to subvert IARC's work. The scientific strategy attempted to undercut IARC's research and to develop industry-directed research to counter the anticipated findings. The communications strategy planned to shape opinion by manipulating the media and the public. The government strategy sought to prevent increased smoking restrictions. The IARC study cost $2 million over ten years; Philip Morris planned to spend $2 million in one year alone and up to $4 million on research. The documents and interviews suggest that the tobacco industry continues to conduct a sophisticated campaign against conclusions that second-hand smoke causes lung cancer and other diseases, subverting normal scientific processes.
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              Quantifying the effects of promoting smokeless tobacco as a harm reduction strategy in the USA.

              Snus (a form of smokeless tobacco) is less dangerous than cigarettes. Some health professionals argue that snus should be promoted as a component of a harm reduction strategy, while others oppose this approach. Major US tobacco companies (RJ Reynolds and Philip Morris) are marketing snus products as cigarette brand line extensions. The population effects of smokeless tobacco promotion will depend on the combined effects of changes in individual risk with population changes in tobacco use patterns. To quantitatively evaluate the health impact of smokeless tobacco promotion as part of a harm reduction strategy in the US. A Monte Carlo simulation of a decision tree model of tobacco initiation and use was used to estimate the health effects associated with five different patterns of increased smokeless tobacco use. With cigarette smoking having a health effect of 100, the base case scenario (based on current US prevalence rates) yields a total health effect of 24.2 (5% to 95% interval 21.7 to 26.5) and the aggressive smokeless promotion (less cigarette use and increased smokeless, health-concerned smokers switching to snus, smokers in smokefree environments switching to snus) was associated with a health effect of 30.4 (5% to 95% interval 25.9 to 35.2). The anticipated health effects for additional scenarios with lower rates of smokeless uptake also overlapped with the base case. Promoting smokeless tobacco as a safer alternative to cigarettes is unlikely to result in substantial health benefits at a population level.
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                Author and article information

                Contributors
                Role: Academic Editor
                Journal
                PLoS Med
                PLoS Med
                PLoS
                plosmed
                PLoS Medicine
                Public Library of Science (San Francisco, USA )
                1549-1277
                1549-1676
                May 2013
                May 2013
                28 May 2013
                : 10
                : 5
                Affiliations
                [1 ]Center for Tobacco Control Research and Education, Department of Medicine, University of California, San Francisco, San Francisco, California, United States of America
                [2 ]Schillerhoehe Hospital, Thoracic Surgery, Gerlingen, Germany
                San Diego State University, United States of America
                Author notes

                The authors have declared that no competing interests exist.

                Conceived and designed the experiments: SAG. Performed the experiments: CET TK SAG. Analyzed the data: CET TK SAG. Wrote the first draft of the manuscript: CET. Contributed to the writing of the manuscript: CET TK SAG. ICMJE criteria for authorship read and met: CET TK SAG. Agree with manuscript results and conclusions: CET TK SAG.

                Article
                PMEDICINE-D-12-02347
                10.1371/journal.pmed.1001450
                3665841
                23723740

                This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

                Page count
                Pages: 22
                Funding
                This work was supported by National Cancer Institute grant CA-087472. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.
                Categories
                Research Article
                Medicine
                Public Health
                Tobacco Control
                Science Policy
                Research Assessment

                Medicine

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