THE ADVERSE HEALTH EFFECTS OF SMOKING AND THE TOBACCO INDUSTRY’S EFFORTS TO LIMIT TOBACCO CONTROL Prepared by: Jonathan M. Samet, MD, MS Director, USC Institute for Global Health Distinguished Professor and Flora L. Thornton Chair, Department of Preventive Medicine, Keck School of Medicine of USC University of Southern California 2001 North Soto Street, Suite 330A Los Angeles, California 90089-9239, USA Phone: +1 323 865 0803 Fax: +1 323 865 0854 Email: [email protected] 1 Table of Contents Summary ....................................................................................................................................................... 4 Professional Qualifications ........................................................................................................................... 6 Approach ....................................................................................................................................................... 9 Introduction and Context ............................................................................................................................ 10 Scientific approaches to smoking and health ......................................................................................... 11 Epidemiological research ........................................................................................................................ 14 Identifying causes of disease................................................................................................................... 15 The identification of the risks of smoking—a century-long perspective ................................................. 17 Evidence-based and evidence-driven tobacco control and its consequences ......................................... 20 Tobacco Industry Actions ............................................................................................................................ 23 Long-standing goal of maintaining/expanding market .......................................................................... 23 Long-standing industry concern about litigation risk because of the deadly risks of its products ......... 24 Health Effects of Active Smoking ................................................................................................................ 26 Emergence of the evidence on smoking and health ............................................................................... 26 The tobacco industry response ............................................................................................................... 27 The 1964 Surgeon General’s report ........................................................................................................ 29 Nicotine Addiction ...................................................................................................................................... 31 Background ............................................................................................................................................. 31 Long-standing industry understanding of role of nicotine and the need to deliver a sufficient nicotine dosage ..................................................................................................................................................... 32 Industry use of ammonia technology to enhance nicotine delivery ....................................................... 34 Other strategies: portraying cigarette smoking as a “choice” and a ”right” .......................................... 35 The 1988 Surgeon General’s report ........................................................................................................ 36 Secondhand Smoke (SHS) ........................................................................................................................... 37 Industry recognition of the critical implications of findings on SHS ........................................................ 37 Emerging evidence on adverse consequences of SHS ............................................................................. 39 Industry responses to evidence on SHS ................................................................................................... 41 • Tactics related to exposure studies ......................................................................................... 41 • Tactics related to epidemiological studies .............................................................................. 42 • Strategies related to expert reports ......................................................................................... 43 • Tactics to limit indoor smoking bans ....................................................................................... 45 2 Light and Low-Tar Cigarettes ...................................................................................................................... 46 Filter cigarettes: the campaign begins .................................................................................................... 47 Implementation of the FTC protocol; misleading numbers ..................................................................... 47 The Success of the Tobacco-Industry Playbook .......................................................................................... 52 References .................................................................................................................................................. 53 3 Summary I have been asked by the law firm Foley Hoag LLP to provide an expert report concerning the evolution of understanding of the adverse consequences of tobacco use and the tobacco industry’s history of misleading the public, including public health authorities, about the adverse health effects of smoking. I understand that this report will be submitted in connection with Uruguay’s pleadings in the investment arbitration brought against it by certain affiliates of the Philip Morris International family of companies. In this report, I provide a broad review of the identification of the adverse health consequences of active and passive smoking; the resulting efforts to control tobacco use; and the tobacco industry’s many efforts to thwart tobacco control. While its focus is on the United States, where this history is best documented, the tactics used in the United States have been used widely by the multi-national tobacco companies, including by Philip Morris. This report describes many of those tactics, which have included: 1) creating uncertainty concerning the scientific foundation of public health action; 2) misinforming and misleading the public concerning the harms of its products; and 3) continually and aggressively attempting to counter efforts to control tobacco use. These various efforts were well funded and often involved activities based in illegal collusion among the companies and fraudulent representations. These tactics delayed and weakened tobacco control, resulting in premature mortality, and additional disease and mortality that could have been avoided. I begin by outlining my professional qualifications and my extensive experience in research on the health risks of smoking and in tobacco control throughout my career (page 6). I note the approach I have taken in developing this report (page 9). In the first section, Introduction and Context, I provide a background on the scientific methods used to establish the harms of smoking and the development of evidence-based approaches to tobacco control (page 10). I follow by highlighting the actions taken by the tobacco industry to maintain smoking and advance sales of its tobacco products by attempting to counter tobacco control efforts (page 23). I then describe the health effects of active smoking (page 26). In the next section, Nicotine Addiction, I provide background on nicotine as the agent of addiction and the cigarette as an effective delivery device for nicotine (page 31). I detail the role that the tobacco industry has long played in sustaining nicotine addiction through tobacco product design and manipulation, while discrediting the scientific evidence that tobacco products and nicotine are addicting. Following this section, I describe the critical findings on the adverse health effects of secondhand smoke exposure, and the tobacco industry’s decades- long strategies and diverse tactics used in an effort to counter the tobacco control implications of 4 the evidence on secondhand smoke (page 37). Next, I outline one of the tobacco industry’s efforts to counter the rising concerns about risks of smoking cigarettes: by designing and manufacturing cigarettes that were marketed as having lesser health risks—the so-called light and low-tar cigarettes—and thus the industry’s deliberate efforts to misinform and mislead the public (page 47). I conclude this report by summarizing the aggressive actions employed by the tobacco industry over the last seven decades to blunt efforts to curb tobacco use in the face of mounting scientific evidence on the health consequences of active and passive smoking (page 52). 5 Professional Qualifications My education and training is in medicine (internal medicine and pulmonary disease) and public health, specifically the discipline of epidemiology (see attached curriculum vitae). I received an A.B. degree from Harvard College in Chemistry and Physics in 1966 and then received my M.D. degree from the University of Rochester School of Medicine and Dentistry in 1970. Training after medical school included completion