Tuesday, May 01, 2012

UCSD Researchers Call Attention to Differences Between Science and Policy on National Smoking Cessation Strategy

Researchers at the University of California, San Diego School of Medicine are calling attention to a major discrepancy between the scientific evidence base and national policy on smoking cessation, according to a press release issued by the university. The researchers, led by Dr. John Pierce, are pointing out that while most smokers who have successfully quit have done so unaided, national cessation policy discourages unaided quitting and in fact insists that every smoker be treated with a drug, a strategy which the UCSD researchers say destroys smokers' confidence in their ability to quit and undermines smoking cessation in the long-run. This perspective is summarized in a review article published in the 2012 Annual Review of Public Health.

According to the review article: "While quit attempts have increased, widespread dissemination of these aids [pharmaceutical aids and quitlines] has not improved population success rates. Pharmaceutical marketing strategies may have reduced expectations of the difficulty of quitting, reducing success per attempt. Some policies actively discourage unassisted smoking cessation despite the documented high success rates of this approach. There is an urgent need to revisit public policy on smoking cessation."

According to the press release: "'For the past decade, attempts to quit smoking have increased, but the proportion of people who become successful quitters has gone down' said John P. Pierce, PhD, professor of Family and Preventive Medicine and director of Population Sciences at UC San Diego Moores Cancer Center. 'Widespread dissemination of cessation services has not led to an increase in the probability that a quit attempt will be successful.'" ... recent evidence suggests that part of the problem may lie in how cessation aids are marketed by pharmaceutical companies: many such ads suggest that quitting smoking may be as simple as putting on a patch. It appears that younger smokers in particular are now more likely to underestimate the amount of work needed in order to quit smoking successfully."

"Traditionally, the majority of smokers who quit successfully have done so without assistance, and recent data suggests that this has not changed.  However, current national policy discourages unassisted quitting, advising clinicians to make sure smokers who want to quit do so with pharmaceutical assistance.  This policy may undermine smokers’ belief in their ability to quit on their own."

The Rest of the Story

These are critical findings which must be considered by tobacco control practitioners and which should lead to a re-thinking of national smoking cessation strategies and policy.

One may ask why there is such a discrepancy between the scientific evidence base and national policy. I believe the answer is that many of the leading researchers and organizations that have developed and disseminated recommendations for a national smoking cessation strategy have strong financial ties to pharmaceutical companies which manufacture smoking cessation drugs. This conflict of interest has led to a systematic bias whereby these researchers and groups have not been able to objectively analyze and interpret the literature, but instead have, albeit subconsciously, slanted the research findings to fit a preconceived belief in the value of pharmaceutical aids.

Just last week I pointed out that the 2012 National Conference on Tobacco or Health is being sponsored by a pharmaceutical company (Pfizer). There is no way that this conference can undertake an objective consideration of the role of smoking cessation drugs as part of national tobacco control strategies. My call on the National Conference on Tobacco or Health to return Pfizer's money and to institute a policy of rejecting pharmaceutical company sponsorship of its conferences has apparently fallen on deaf ears. As a result, this conference can no longer claim to be an objective scientific conference which serves the purpose of undertaking an objective, evidence-based consideration of "the latest evidence on what works in tobacco control."

This is just one recent example of the way in which the tobacco control field has become systematically biased because of the receipt of pharmaceutical company funding.

Another example of this systematic bias is the fact that the chair of the expert panel which made the national smoking cessation treatment recommendation in the first place had access to up to $50,000 in annual resources from GlaxoSmithKline to support his educational, research, and policy activities. In addition, the panel chair has a history of doing outside consulting work for pharmaceutical companies which on an annual basis ranged between about $10,000 and $40,000 per year. In the past, he has has served as a consultant for, given lectures sponsored by, or has conducted research sponsored by Ciba-Geigy, SmithKline Beecham, Lederle Laboratories, McNeil Consumer Products, Elan Pharmaceutical, Pharmacia, and Glaxo Wellcome. In addition, he has lectured and consulted for Pfizer and has served as an investigator on research studies at the University of Wisconsin (UW) that were supported by GlaxoSmithKline, Nabi, Pfizer, and sanofi-aventis.

Another aspect of the problem is that the conflicted researchers and organizations do not seem to appreciate the magnitude of this conflict of interest or the degree to which it could potentially affect their objectivity. In some cases, the disclosure of these conflicts has not been forthcoming or completely transparent, as appears to be the case with this 2006 disclosure, in which the signer (the chair of the NIH expert panel on smoking cessation treatment) fails to disclose his history, within the past 5 years according to his sworn testimony, of receiving consulting income on the order of tens of thousands of dollars during the past 5 years. This testimony was given in 2005; thus, his testimony indicates that the period during which he received consulting income from Big Pharma corresponds to the 5-year period about which his 2006 disclosure inquires.

In his testimony, the panel chair states: "Separately, I have done some consulting work for pharmaceutical companies over the years. Over the past five years, my outside consulting work on an annual basis has ranged between about $10,000 and $30,000 or $40,000 per year." Yet his signed initial disclosure for the NIH panel the following year reveals only that: "In keeping with recent JAMA recommendations, Dr. Fiore does not accept honorarium nor do consulting work for the pharmaceutical industry." Since the form requires disclosure of all financial interests during the past 5 years, the interpretation of this disclosure statement is that Dr. Fiore does not currently do consulting work for the pharmaceutical industry, and has not done such consulting work for the past 5 years. Based on Dr. Fiore's testimony, this appears not to be true. Thus, this appears to be a bit dishonest or misleading, or at very least, a flawed and incomplete disclosure.

Moreover, there are other examples of scientific articles on the effectiveness of pharmaceutical aids for smoking cessation in which the conflicts of interest with Big Pharma are not adequately or completely disclosed. For example, in a 2009 nicotine gum study, the financial conflicts of interest of the study site principal investigators are not disclosed. I was able to find out about these financial conflicts only after hours of research using databases that are not publicly available. I think readers of this article would be shocked to find out, for example, that one of the study site principal investigators had consulted for GlaxoSmithKline, manufacturer of nicotine gum, as well as for 20 other pharmaceutical companies. This type of information, especially because it is not disclosed, really puts the validity of the study findings and conclusions in question.

As another example, in 2009, the Association for the Treatment of Tobacco Use and Dependence (ATTUD) issued a press release to promote a ban on the sale of electronic cigarettes in the United States. The press release highlighted a letter written from the organization to the FDA requesting that the Agency remove electronic cigarettes from the market. However, the press release and letter failed to reveal that Dr. John Hughes - who is one of the co-signers of the letter to the FDA - apparently has conflicts of interest by virtue of his having consultancies, honoraria, and research grants/contracts with pharmaceutical companies.

Elsewhere (Drug and Alcohol Dependence, Volume 98, Issue 3, 1 December 2008, Pages 169-178), Dr. Hughes has disclosed that: "In the last 3 years he has received research grants from the National Institute on Health and Pfizer Pharmaceuticals and Sanofi-Synthelabo Pharmaceuticals both of whom are developing smoking cessation treatments. In the last three years, he has accepted honoraria or consulting fees from the following profit or non-profit institutions regarding nicotine or other drug abuse topics: Academy for Educational Development, Acrux DDS; American College of Chest Physicians, Adelphi Consulting, Aradigm; Atrium, Baltimore Research, Campus Consulting, Cambridge Press, Cline, Davis and Mann; Concepts in HealthCare, Constella Group; Consultants in Behavior Change; Cowen Inc, Cygnus, Edelman, Fagerstrom Consulting; Free and Clear; Healthwise, Health Learning Systems, International Marketing Systems, Insyght; Johns Hopkins University; Maine Medical Center, McNeil, Medicus, Nabi, National Institutes on Health; NCI Consulting, Pfizer Pharmaceuticals; Pinney Associates; Research Triangle Institute, Shire Health London; Temple University of Health Sciences; University of Arkansas, University of Auckland; University of Cantabria; University of Greifswald; University of Kentucky, University of Memphis, Warner Pharmaceuticals, Wolters Press, Xenova, and ZS Associates."

Thus, Dr. Hughes is essentially a walking conflict of interest with Big Pharma. But none of this was disclosed in the letter to the FDA or the press release as they appeared on the internet.

The other co-signer of the letter to the FDA demanding a ban on electronic cigarettes - the current ATTUD president at the time - Dr. Michael Burke, had also apparently received honoraria from Pfizer Health Solutions, a subsidiary of the pharmaceutical company Pfizer, according to a disclosure posted on the ATTUD web site. This was also not disclosed in the letter to the FDA or the press release as they appeared on the internet.

The rest of the story is that there is a disconnect between the scientific evidence base and national policy on smoking cessation treatment. And the reason for this discrepancy is the existence of severe financial conflicts of interest among some of the leading researchers and organizations that have pushed for the current national cessation policy. The problem is rounded out by an apparent lack of regard for the importance of these conflicts of interest and the failure to disclose them in all statements making recommendations about national smoking cessation treatment policy.

Worst of all, there does not appear to be any interest in resolving the problem. My call for the divestment of the National Conference on Tobacco or Health from Big Pharma has fallen on deaf ears, as have similar appeals to several other major tobacco control organizations and conferences. There is, in fact, no resolution in sight.

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