Financial Conflicts of Interest and Stance on Tobacco Harm Reduction: A Systematic Review.

Background. Tobacco companies have actively promoted the substitution of cigarettes with purportedly safer tobacco products (e.g., smokeless tobacco, e-cigarettes) as tobacco harm reduction (THR). Given the tobacco, e-cigarette, and pharmaceutical industries' substantial financial interests, we quantified industry influence on support for THR. Objectives. To analyze a comprehensive set of articles published in peer-reviewed journals assessing funding sources and support for or opposition to substitution of tobacco or nicotine products as harm reduction. Search Methods. We searched PubMed, Embase, Web of Science, and PsycINFO with a comprehensive search string including all articles, comments, and editorials published between January 1, 1992, and July 26, 2016. Selection Criteria. We included English-language publications published in peer-reviewed journals addressing THR in humans and excluded studies on modified cigarettes, on South Asian smokeless tobacco variants, on pregnant women, on animals, not mentioning a tobacco or nicotine product, on US Food and Drug Administration-approved nicotine replacement therapies, and on nicotine vaccines. Data Collection and Analysis. We double-coded all articles for article type; primary product type (e.g., snus, e-cigarettes); themes for and against THR; stance on THR; THR concepts; funding or affiliation with tobacco, e-cigarette, pharmaceutical industry, or multiple industries; and each author's country. We fit exact logistic regression models with stance on THR as the outcome (pro- vs anti-THR) and source of funding or industry affiliation as the predictor taking into account sparse data. Additional models included article type as the outcome (nonempirical or empirical) and industry funding or affiliation as predictor, and stratified analyses for empirical and nonempirical studies with stance on THR as outcome and funding source as predictor. Main Results. Searches retrieved 826 articles, including nonempirical articles (21%), letters or commentaries (34%), editorials (5%), cross-sectional studies (15%), systematic reviews and meta-analyses (3%), and randomized controlled trials (2%). Overall, 23.9% disclosed support by industry; 49% of articles endorsed THR, 42% opposed it, and 9% took neutral or mixed positions. Support from the e-cigarette industry (odds ratio [OR] = 20.9; 95% confidence interval [CI] = 5.3, 180.7), tobacco industry (OR = 59.4; 95% CI = 10.1, +infinity), or pharmaceutical industry (OR = 2.18; 95% CI = 1.3, 3.7) was significantly associated with supportive stance on THR in analyses accounting for sparse data. Authors' Conclusions. Non-industry-funded articles were evenly divided in stance, while industry-funded articles favored THR. Because of their quantity, letters and comments may influence perceptions of THR when empirical studies lack consensus. Public Health Implications. Public health practitioners and researchers need to account for industry funding when interpreting the evidence in THR debates.

Revolution or redux? Assessing IQOS through a precursor product.

BACKGROUND: Philip Morris International (PMI) currently claims that its heated tobacco product, IQOS, reduces health risk by reducing users' exposure to harmful and potentially harmful constituents present in tobacco smoke. Given the tobacco industry's long history of misrepresenting and obfuscating research, independent assessment of PMI's claims is important. Analysis of Accord, a failed but strikingly similar precursor to IQOS, may help contextualise PMI's claims in its Modified Risk Tobacco Product (MRTP) application. METHODS: We analysed previously secret internal Philip Morris (PM) and PMI documents, public communications and MRTP application. RESULTS: PM marketed Accord as a 'cleaner' tobacco product in an attempt to address smokers' growing health concerns without making explicit health claims. While PM communications asserted that Accord reduced users' exposure to harmful constituents, company scientists and executives consistently stressed to both regulators and the public that such reductions did not render Accord safer. IQOS's design and marketing are similar to Accord's. On the basis of aerosol chemistry data, IQOS reduces user exposure to some compounds compared with Accord but raises them for others. DISCUSSION: IQOS appears to be a variant of Accord without consistent improvements in exposure to aerosol toxic compounds. In contrast to PM's past claims for Accord, PMI now claims in its MRTP application that IQOS reduces health risk. This shift in stance is likely not the result of any toxicological difference between Accord and IQOS, but rather a change in the social and regulatory landscape permitting these claims.

Invisible smoke: third-party endorsement and the resurrection of heat-not-burn tobacco products.

BACKGROUND: Tobacco companies are introducing new 'heat-not-burn' cigarettes in dozens of countries. Historically, these products failed commercially, and independent researchers contested their health claims. The most prominent early heat-not-burn cigarette was RJ Reynolds's (RJR's) Premier, introduced in the USA in 1988. Curiously, The Lancet endorsed Premier as a 'near-perfect low tar cigarette' in a 1991 editorial, 2 years after Premier had been removed from the market. We examined the context of this endorsement. METHODS: To ascertain what RJR knew about this endorsement, we systematically searched and analysed previously secret RJR documents in public archives and triangulated the industry document data with other published work. RESULTS: RJR had a long-standing interest in collaborating with outside scientists to endorse potentially reduced harm cigarettes. The author of The Lancet editorial had previously corresponded with RJR regarding Premier's health effects and market potential. Internally, RJR regarded The Lancet's editorial, its stance on novel tobacco products, and its endorsement of Premier as major successes. While the editorial came too late to save Premier, RJR saw future business opportunities for novel products if endorsed by health authorities. CONCLUSIONS: Endorsement by high-impact medical journals and health authorities may be critical in helping heat-not-burn' products succeed where previous attempts have failed. Conflicts of interest influenced these endorsements in the past. Health leaders and academic journals should consider both conflicts of interest and the ethics of endorsing tobacco product substitution, as tobacco companies simultaneously work to promote cigarette smoking and undermine tobacco control globally.

Public versus internal conceptions of addiction: An analysis of internal Philip Morris documents.

BACKGROUND: Tobacco addiction is a complex, multicomponent phenomenon stemming from nicotine's pharmacology and the user's biology, psychology, sociology, and environment. After decades of public denial, the tobacco industry now agrees with public health authorities that nicotine is addictive. In 2000, Philip Morris became the first major tobacco company to admit nicotine's addictiveness. Evolving definitions of addiction have historically affected subsequent policymaking. This article examines how Philip Morris internally conceptualized addiction immediately before and after this announcement. METHODS AND FINDINGS: We analyzed previously secret, internal Philip Morris documents made available as a result of litigation against the tobacco industry. We compared these documents to public company statements and found that Philip Morris's move from public denial to public affirmation of nicotine's addictiveness coincided with pressure on the industry from poor public approval ratings, the Master Settlement Agreement (MSA), the United States government's filing of the Racketeer Influenced and Corrupt Organizations (RICO) suit, and the Institute of Medicine's (IoM's) endorsement of potentially reduced risk products. Philip Morris continued to research the causes of addiction through the 2000s in order to create successful potentially reduced exposure products (PREPs). While Philip Morris's public statements reinforce the idea that nicotine's pharmacology principally drives smoking addiction, company scientists framed addiction as the result of interconnected biological, social, psychological, and environmental determinants, with nicotine as but one component. Due to the fragmentary nature of the industry document database, we may have missed relevant information that could have affected our analysis. CONCLUSIONS: Philip Morris's research suggests that tobacco industry activity influences addiction treatment outcomes. Beyond nicotine's pharmacology, the industry's continued aggressive advertising, lobbying, and litigation against effective tobacco control policies promotes various nonpharmacological determinants of addiction. To help tobacco users quit, policy makers should increase attention on the social and environmental dimensions of addiction alongside traditional cessation efforts.

Origins of tobacco harm reduction in the UK: the 'Product Modification Programme' (1972-1991).

OBJECTIVE: To better understand the current embrace of long-term nicotine maintenance by British governmental agencies and tobacco harm reduction by several leading British public health organisations, describe the context and deliberations of the UK's first formal tobacco risk reduction programme: 'Product Modification'. METHODS: Analysis of previously secret tobacco industry documents, news archives and Parliamentary debate records. RESULTS: From 1972 to 1991, the British government sought to investigate safer smoking through the 'product modification programme'. The Independent Scientific Committee on Smoking and Health (ISCSH) advised the British government on these efforts and collaborated with the tobacco industry, with which government then negotiated to determine policy. The ISCSH operated from four industry-backed premises, which contributed to the ISCSH's support of safer smoking: (1) reduced toxicity indicates reduced risk; (2) collaboration with the tobacco industry will not undermine tobacco control; (3) nicotine addiction is unavoidable; (4) to curtail cigarette use, solutions must be consumer-approved (ie, profitable). These premises often undermined tobacco control efforts and placed the ISCSH at odds with broader currents in public health. The product modification programme was abandoned in 1991 as the European Community began requiring members to adopt upper tar limits, rendering the ISCSH redundant. POLICY IMPLICATIONS: Endorsements of reduced harm tobacco products share the same four premises that supported the product modification programme. Current tobacco harm reduction premises and policies supported by the British government and leading British public health organisations may reflect the historical influence of the tobacco industry.