Yet Another Study Shows that Nicotine Replacement Therapy Has Not Improved Population Cessation Rates

A new study published in the journal Tobacco Control concludes that the proliferation of smoking quit lines and the greatly increased use of nicotine replacement therapy over the past two decades have not led to improvements in the rate of smoking cessation on a population level.

(See: Shu-Hong Zhu, Madeleine Lee, Yue-Lin Zhuang, Anthony Gamst, Tanya Wolfson. Interventions to increase smoking cessation at the population level: how much progress has been made in the last two decades? Tobacco Control 2012;21:110e118. doi:10.1136/tobaccocontrol-2011-050371)

The study used data from the National Health Interview Survey to examine trends in the population rates of smoking cessation during the period 1991-2010. The findings were as follows: "Cessation rates vary from year to year, but there is no significant upward trend for the whole period. Attempts to fit a linear trend for these two panels of data (weighted by the sample size for each survey year) found the slopes are slightly negative but not statistically significantly different from zero (r=-0.02, p=0.94, all smokers, and r=-0.17, p=0.50 for white smokers)."

The study concludes: "Most importantly, there is no consistent upward trend, which would be expected given the various interventions that have been implemented in the USA over the last two decades. This is a perplexing result."

The article offers several possible explanations for the study findings. Two of the most critical are: (1) "the true effects of interventions are much smaller than reported"; and (2) "an overemphasis on the power of medications to help smokers quit may lead them to think they cannot quit without the medications, lowering self-efficacy and reducing the base rate of quitting."

The Rest of the Story

The paper correctly notes that: "Pharmacotherapies such as nicotine patches are recommended as first-line quit-smoking aids in clinical practice guidelines." Despite the explosive increase in the promotion of these products for smoking cessation over the past two decades, there has been no improvement in population smoking cessation rates.

This research reinforces the findings of a previous study by Pierce et al., which came to the same conclusion (see: Pierce JP, Cummins SE, White MM, Humphrey A, Messer K. Quitlines and nicotine replacement for smoking cessation: Do we need to change policy? Annu Rev Public Health 2012; 33:12.1-12.16).

This research highlights a major problem in the anti-smoking movement: Because of the strong pharmaceutical company ties of the leading anti-smoking researchers and organizations, there has not been an objective assessment of the effectiveness of smoking cessation policy, and this has led to an over-emphasis on nicotine replacement therapy and an exaggeration of its benefits.

Not only has the obsession with nicotine replacement therapy and other smoking cessation drugs harmed the public's health by diverting attention away from more effective national approaches, but it has also harmed public health because, as the authors of the present study correctly note: "an overemphasis on the power of medications to help smokers quit may lead them to think they cannot quit without the medications, lowering self-efficacy and reducing the base rate of quitting."

It would be one thing if the flawed advice being given by the NIH expert panel on smoking cessation (i.e., every smoker should be treated with pharmaceutical agents unless specifically contraindicated) were due simply to an innocent mistake, such as lack of complete knowledge of the effectiveness of various smoking cessation strategies. However, I believe that this is not an innocent mistake. Instead, it is the direct result of financial conflicts of interest which have clouded the judgment of those making national recommendations, including the NIH expert panel on smoking cessation, whose recommendations have heavily influenced the anti-smoking movement and helped to produce today's overemphasis on the power of medications to help smokers quit.

Far from being an objective review and assessment of the best possible strategy to enhance smoking cessation among smokers in the United States, the smoking cessation clinical practice guideline is a heavily biased analysis that is plagued by the presence of severe financial conflicts of interests among the panel's chair and at least 8 of its other members.

These 9 panel members have received, or are currently receiving, funding from pharmaceutical companies. Most of the involved companies stand to gain from the clinical practice guideline's recommendations, because these companies manufacture drugs recommended by the panel.

Here is the long list of financial conflicts of interest among this supposedly objective panel of expert scientists:

Michael C. Fiore (panel chair): "reported that he served as an investigator on research studies at the University of Wisconsin (UW) that were supported wholly or in part by four pharmaceutical companies, and in 2005 received compensation from one pharmaceutical company. In addition, he reported that, in 1998, the UW appointed him to a named Chair, which was made possible by an unrestricted gift to the UW from GlaxoWellcome."

William C. Bailey: "reported significant financial interests in the form of compensation from three different pharmaceutical companies in 2006 and two in 2007 for speaking engagements."

Timothy B. Baker: "reported that he has served as a co-investigator on research studies at the University of Wisconsin that were sponsored by four pharmaceutical companies."

Neal L. Benowitz: "reported significant financial interest in the form of compensation from one pharmaceutical company for each of the years 2005-2007, as well as stock ownership in one pharmaceutical company."

Michael G. Goldstein: "reported that his employer received support from Bayer Pharmaceutical prior to 2005 and that he was employed by Bayer Pharmaceutical Corporation prior to January 1, 2005. His organization received payments for his professional services from two pharmaceutical companies and one commercial Internet smoking cessation site during the period 2005-2007."

Harry A. Lando: "reported serving on an advisory panel for a new tobacco use cessation medication and attending 2-day meetings in 2005 and 2006 as a member of this panel."

C. Tracy Orleans: "reported significant financial interests in the form of a dependent child who owns pharmaceutical stock... ."

Maxine L. Stitzer: "reported participation on a pharmaceutical scientific advisory panel for a new tobacco use cessation medication."

Sally Faith Dorfman: "reported her employment by Ferring Pharmaceuticals, Inc., a company whose business does not relate to treating tobacco dependence."

GlaxoWellcome, which apparently endowed the Chair position that the chair of the panel enjoys, is the manufacturer of Wellbutrin, Commit lozenge, Committed Quitters, NiQuitin/Nicoderm, Nicabate, and Nicorette. The use of all of these drugs is recommended by the panel.

What this means is that we basically have a group of experts who are largely financially linked with pharmaceutical companies, and who stand to gain personally if they recommend the use of pharmaceuticals as part of their smoking cessation guidelines. The more use of pharmaceuticals they recommend, the more they stand to gain.

This is a conflict of interest in the ugliest way that I can imagine. It is precisely the type of thing that needs to be stopped.

Ironically, it is the Department of Health and Human Services, the Public Health Service, and NIH itself which are regulating conflicts of interest among America's medical researchers. To have such a huge conflict of interest in its own supported work is unconscionable.

While I find it objectionable that these agencies would allow experts with these type of financial conflicts of interest to serve on the panel, I find it equally troubling that such individuals would agree to serve. I believe that based on these conflicts, these experts should have recused themselves from service on the panel.

The conflict in this case is not just a hypothetical one. It reveals itself in the extreme bias of the guideline. The analysis over-estimates the benefit of drugs in smoking cessation and overlooks population-based evidence showing that most people who quit smoking do so without pharmaceutical aids.

As my colleague Dr. Lois Biener of the University of Massachusetts Boston argued in an Associated Press article about the guideline, there is little if any "real-world evidence" that when used outside the context of clinical trials, drugs produce any long-term enhancement of smoking cessation, and certainly not the magnitude of benefit as suggested by those who are touting the importance of these drugs.

One national expert on smoking cessation who was not on the panel - John Polito - has suggested that the guideline is basically a "sales pitch" for the pharmaceutical industry, that the benefits of pharmaceuticals are overstated, that the value of quitting cold turkey is not considered, and that the recommendation to promote Chantix use is misguided and could cause harm.

Polito has really stated it better than I could and he is right on the mark. The guideline is basically a sales pitch for the pharmaceutical industry, and it demonstrates what corporations can buy through their payments to scientific experts.

What's most disturbing to me is that while the medical field continues to move to decrease the influence of pharmaceutical companies on physicians by restricting financial benefits for doctors, the tobacco control field seems to be increasingly plagued by this pharmaceutical influence. The problem is being ameliorated in medicine, but in tobacco control, it continues to get worse.

The ultimate irony of all of this is that we in tobacco control have been so vehement in decrying the tobacco industry's influence on science. We have attacked and berated scientists for having financial ties to tobacco companies. We have discredited scientific conclusions based solely on the financial connections of the authors to Big Tobacco. But now, our national policies are being set by individuals who have equally strong connections to Big Pharma.

It may come as a surprise to many in tobacco control, but this type of science is just as bad. Bad science is bad science. Conflicts of interest are conflicts of interest. Believe me, the science doesn't get any stronger just because it is a less detestable industry. As a field which has literally helped to ruin the careers of scientists with tobacco industry connections, we should be beyond reproach in not allowing similar conflicts of interest to degrade and poison our science.