A New Policy on Tobacco Papers
February 23, 2010
This past month PLoS Medicine published two original analyses on smoking, the single greatest preventable risk for poor health and death in the developed world, and an increasingly important risk factor in the developing world. The first study, using internal tobacco company documents unsealed through litigation, provides further evidence of the already well-documented strategy of deception used by the tobacco industry to further its commercial activities. The second study shows the ways in which the tobacco control agenda is distorted by the increasing medicalization of smoking cessation.
In the first paper, Katherine Smith and colleagues report how British American Tobacco (BAT), the world's second largest tobacco transnational, strategically influenced the European U nion's framework for evaluating policy options, leading to the acceptance of an agenda that emphasizes business interests over public health [1]. The researchers examined over 700 internal BAT documents that contain information on the company's attempts to influence European regulatory reform and conducted interviews with European policymakers and lobbyists. Their analyses show that BAT created a policy network of representatives from many corporations involved in marketing products that are damaging to public health and the environment, which then successfully campaigned to have specific changes made to the EU Treaty that allowed policymakers to reduce the regulatory burden on businesses. These changes therefore set up conditions that may allow future European policy to favor businesses rather than the health of citizens.
In the second paper, Simon Chapman and Ross MacKenzie critique the dominant messages about smoking cessation contained in most tobacco control campaigns, which emphasize that serious attempts at quitting smoking must be pharmacologically or professionally mediated [2]. This has led to the medicalization of smoking cessation. In fact, argue the authors, there is good evidence that the most successful methods used by most ex-smokers are quitting “cold turkey” or reducing then quitting. The medicalization of smoking cessation is propped up by the extent and influence of pharmaceutical support for cessation intervention studies, say the authors. They cite a recent review of randomized controlled trials of nicotine replacement therapy that found that 51% of industry-funded trials reported significant cessation effects, while only 22% of non-industry trials did [3].
This month also marks the implementation of a new policy on tobacco papers at PLoS Medicine.
While we continue to be interested in analyses of ways of reducing tobacco use, we will no longer be considering papers where support, in whole or in part, for the study or the researchers comes from a tobacco company. As a medical journal we do this for two reasons. First, tobacco is indisputably bad for health. Half of all smokers will die of tobacco use [4]. Unlike the food and pharmaceutical industries, the business of tobacco involves selling a product for which there is no possible health benefit. Tobacco interests in research cannot have a health aim—if they did, tobacco companies would be better off shutting down business—and therefore health research sponsored by tobacco companies is essentially advertising. Publication is part of tobacco company marketing, and we believe it would be irresponsible to act as part of the machinery that enhances the reputation of an industry producing health-harming products.
Second, we remain concerned about the industry's long-standing attempts to distort the science of and deflect attention away from the harmful effects of smoking. That the tobacco industry has behaved disreputably—denying the harms of its products, campaigning against smoking bans, marketing to young people, and hiring public relations firms, consultants, and front groups to enhance the public credibility of their work—is well documented. There is no reason to believe that these direct assaults on human health will not continue, and we do not wish to provide a forum for companies' attempts to manipulate the science on tobacco's harms.
Furthermore, the business model used to support our open access publishing (the research funder covers publication costs, unless the author requests a waiver) means we would essentially be accepting money from the tobacco industry by publishing their papers. This is unacceptable to the editorial team of PLoS Medicine.
Our new policy may be criticized as moralistic, unscientific, and against transparency. Indeed, the leading tobacco control journal (Tobacco Control) does not ban tobacco industry–funded research, for two reasons: it wishes to avoid being labeled as biased by the industry, and it does not think it sensible to single out tobacco when the food and drug industries also have deeply vested and conflicted interests in the research supporting their corporate agendas [5]. Journals such as BMJ have also rejected a ban on research papers from authors funded by the tobacco industry, citing such a move as a form of unacceptable censorship and instead managing the potential competing interests as it would all papers [6]. Ten years ago, one of us (GY) argued for the BMJ position [7], but has changed his view over the last decade in the face of increasing evidence of the tobacco industry's distortion of science.
But other journals such as those of the American Thoracic Society do have such policies—since 1995 they have not accepted any medical research that is funded by the tobacco industry, and they explicitly do so on moral and ethical grounds [8].
Like the two other PLoS journals that have recently adopted this policy, PLoS Biology and PLoS ONE, we feel that any potential criticisms and risks are preferable to supporting the tobacco industry's efforts to deflect attention from the harms of its products. It is the case that we do not receive many tobacco industry sponsored papers—PLoS Medicine has published none since our inception in 2004 and PLoS ONE only two—and we have made previous editorial judgments on papers that might be favorable to the tobacco industry agenda on a case-by-case basis [9]. We wish now to formalize our policy effective immediately.
Author Contributions Top
Wrote the first draft of the paper: JC. Contributed to the writing of the paper: VB SJ LP EV GY.
References Top
1. Smith KE, Fooks G, Collin J, Weishaar H, Mandal S, et al. (2010) “Working the System”—British American Tobacco's Influence on the European U nion Treaty and Its Implications for Policy: An Analysis of Internal Tobacco Industry Documents. PLoS Med 7: e202. doi:10.1371/journal.pmed.1000202.
2. Chapman S, MacKenzie R (2010) The Global Research Neglect of Unassisted Smoking Cessation: Causes and Consequences. PLoS Med 7: e216. doi:10.1371/journal.pmed.1000216.
3. Stead L, Perera R, Bullen C, Mant D, Lancaster T (2007) Nicotine replacement therapy for smoking cessation. Cochrane Database Syst Rev CD000146: Find this article online
4. Doll R, Peto R, Boreham J, Sutherland I (2004) Mortality in relation to smoking: 50 years' observations on male British doctors. BMJ 328: 1519. Find this article online
5. Chapman S (2005) Research from tobacco industry affiliated authors: Need for particular vigilance. Tob Control 14: 217–219. Find this article online
6. Roberts J, Smith R (1996) Publishing research supported by the tobacco industry. BMJ 12: 133–134. Find this article online
7. King J, Yamey G, Smith R (2000) For and against: Why journals should not publish articles funded by the tobacco industry BMJ 321: 1074. Find this article online
8. Caplan AL (1995) Should our journals publish research sponsored by the tobacco industry? Con: the smoking lamp should not be lit in ATS/ALA publications. Am J Respir Cell Mol Biol 12: 125–126. Find this article online
9. The PLoS Medicine Editors (2007) Tobacco substitutes: Harm reduction or smokescreen? PLoS Med 4: e244. doi:10.1371/journal.pmed.0040244.
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New Study Shows That Even Extended Nicotine Replacement Therapy is Extremely Ineffective; Unaided Quitting Rates are Far Better

March 4, 2010
Michael Siegel

A study published in a recent issue of the Annals of Internal Medicine finds that even with continuous use of the nicotine patch for six months, very few smokers were able to stay off cigarettes long-term. In fact, the rates of long-term abstinence with the nicotine patch were far lower than even the lower end of unaided long-term quit rates. The research demonstrates that nicotine replacement therapy is terribly ineffective in achieving smoking cessation, is less effective than unaided quitting, and is probably a waste of time and money on a population basis.

Previous research has shown that unaided quit attempts yield one-year continuous abstinence rates of between 3% and 11%. Gritz et al. found that in high-motivation situations, such as the Great American Smokeout or New Year's Day resolutions, unaided quitting yielded a one-year continuous abstinence rate of 11%. Nevertheless, a generally accepted value for long-term one-year abstinence with unaided quitting is somewhere around 3% or 5%.

So, with that as a background, take a guess as to how many of the 568 subjects in the study of nicotine patch therapy were able to achieve continuous one-year abstinence (half of these subjects used the patch for 2 months and half used it for 6 months).

Here are your choices:

A. 9 (1.5%)
B. 11 (2.0%)
C. 17 (3.0%)
D. 28 (5.0%)
E. 62 (11.0%)
F. 114 (20.0%)

The answer is ....

... None of the above. The actual number of subjects who achieved one-year continuous abstinence with the nicotine patch was 5, or only 0.8% of the sample.

Even assuming that unaided quit attempts yield a long-term continuous abstinence rate of only 3%, use of the nicotine patch did not even come close to achieving a 3% long-term continuous success rate.

Interestingly, despite these results, the paper concludes that extended-therapy nicotine patch therapy is effective. In fact, it only mentions the 0.8% long-term success rate in fine print in the results section, ignoring this critical result in the abstract and discussion section.

Even the point-prevalence abstinence rate at one year with extended-therapy nicotine patch use was a dismal 14.5%, and was no better than the point-prevalence abstinence rate at one year with short-term nicotine patch therapy (14.3%), calling into question the paper's odd conclusion that extended-use nicotine patch therapy is effective.

The Rest of the Story

This study adds to the growing body of research that pharmaceutical treatment of smoking dependence is a dismal intervention and that unaided quitting is more effective than the use of nicotine replacement therapy or other drug approaches. Nicotine replacement therapy has no business being the mainstay of the nation's strategy for smoking cessation.

In light of these findings, one might ask the question of how the paper could possibly conclude that long-term nicotine patch therapy is effective and why it buries its own finding that only 5 of the 568 subjects achieved long-term continuous abstinence.

We can't be sure, but I can tell you for sure that one of the following statements is true. Your role is to figure out which one it is. The choices are:

A. A rate of 0.8% for long-term continuous abstinence is actually very high. If 8 out of 1000 patients quits long-term, that is the sign of a very effective medical treatment.

B. A rate of 0.8% for long-term continuous abstinence is actually very high because long-term quit rates for unaided quit attempts are only about 0.2%.

C. These quit rates are artificially low because people who enter into clinical trials on smoking cessation are a highly unmotivated group.

D. The senior author of the study has a severe financial conflict of interest as she has served as a consultant to GlaxoSmithKline, one company that manufactures the nicotine patch. She has also served as a consultant or has received research funding from AstraZeneca, Pfizer, and Novartis.

The answer is ...

... D. The senior author of the study has a severe financial conflict of interest as she has served as a consultant to GlaxoSmithKline, one company that manufactures the nicotine patch. She has also served as a consultant or has received research funding from AstraZeneca, Pfizer, and Novartis.

The almost laughable irony is that the major anti-smoking groups are calling on electronic cigarettes to be pulled off the market and banned because they are concerned that the long-term success rates of these products may not be very high and they would rather that smokers stick with the "proven" nicotine replacement therapy drugs. But the rest of the story is that of 568 patients treated with these "proven" nicotine replacement drugs, only five achieved long-term continuous abstinence, far fewer than would have been expected with unaided cessation.

The not so laughable irony is that every one of the anti-smoking groups which has called for electronic cigarettes to be pulled off the market because their effectiveness has not been shown to be as "great" as nicotine replacement therapy has a financial conflict of interest with pharmaceutical companies that manufacture the smoking cessation drugs.
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