Thursday, January 19, 2012

New Study Reveals that Widespread Use of Nicotine Replacement Therapy and Quitlines Has Not Increased Cessation Rates; Quitting Cold Turkey Still Best

A groundbreaking study published in the upcoming 2012 issue of the Annual Review of Public Health challenges the wisdom of the nation's entire approach to smoking cessation.

The study examines quit rates over the past five decades and finds that despite the widespread proliferation of smoking cessation quitlines and the increasing use of smoking cessation drugs like NRT and Chantix during the past decade, the rate of successful quitting among smokers has not improved.

(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)

The study finds that while the number of quit attempts has greatly increased in the past decade, the rate of successful smoking cessation has not changed. This means that the use of smoking cessation drugs and telephone quitlines has not resulted in an improvement in the proportion of smokers who are able to quit smoking successfully over the long-term.

The study also argues that the smoking cessation Clinical Practice Guideline, established by an expert panel in 2008, is not evidence-based because it recommends that every smoker be treated with smoking cessation drugs, even thought the science suggests that unaided quitting is more effective. According to the study, the three-month success rate with NRT is only 19% for light smokers, compared to 26% for unaided quitting. For heavy smokers, the three-month success rate is 9% for NRT compared to 15% for unaided quitting.

The authors write: "In the United States, both the 2008 Update of the Clinical Practice Guideline and the 2011 Joint Commission on Standards on Smoking Cessation for Hospitals recommended that every smoker be treated or offered a pharmaceutical cessation aid... . ... Given the above-mentioned research, it would appear that this recommendation is based on questionable science. ... the majority of successful quitters have achieved that status without assistance... ."

The article concludes: "In randomized trials, pharmaceutical aids have significantly increased cessation among heavy smokers who seek help to quit. ... These results have encouraged governments to recommend strongly that pharmaceutical aids be used in all quit attempts, and many have provided free NRT to smokers who call quitlines. To date, there is no evidence that such policies lead to an increase in successful cessation in the population. .. That successful smoking cessation has not increased ... despite the increased efforts focused on it suggests that there is an urgent need to revisit current tobacco control policy."

The Rest of the Story

Coming on the heels of the Alpert et al. article I highlighted last week, which produced population-based data from Massachusetts showing that NRT has had no effect on smoking cessation, we now have a salvo of articles that challenge the dogma of the tobacco control movement and suggest a lack of a science base for the entire basis of national smoking cessation policy.

Current smoking cessation policy is based on the use of NRT and quitlines, with expenditures going almost exclusively to these two areas. Current clinical guidelines, as well as government recommendations for smoking cessation, are based on the premise that all smokers should be treated with pharmaceutical agents.

The new research demonstrates, however, that there is no scientific evidence to support current policy. Moreover, there is strong population-based evidence which suggests that current policy is misguided. As I argued in my earlier piece on the Alpert et al. study: "with limited funding available, using those funds to provide NRT is of limited value. Instead, limited public funding for tobacco control should be used for proven programs such as smoking prevention media campaigns, which have been shown to reduce youth smoking by as much as 50%." If all expenditures currently going into quitlines and the provision of free NRT were diverted to anti-smoking media campaigns, I believe there would be a substantial increase in smoking cessation and a decline in smoking prevalence.

What is most unfortunate is that the current national policy is not based on scientific advice from unconflicted, unbiased scientific experts. Instead, the policy is based largely on advice from scientists who have financial conflicts of interest by virtue of their having received money from pharmaceutical companies that manufacture smoking cessation drugs.

One thing that both the Clinical Practice Guideline and the Joint Commission standard have in common is a conflicted expert - Dr. Michael Fiore - behind both of them. Dr. Fiore chaired the committees which were responsible for both of these guidelines. Yet Dr. Fiore has severe conflicts of interest.

In 2008, Dr. Fiore reported "that 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."

In his 2005 testimony, Dr. Fiore also admits that he did "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."

In 2000, Dr. Fiore reported that he "has served as a consultant for, given lectures sponsored by, or has conducted research sponsored by Ciba-Geigy, SmithKline Beecham, Lederle Laboratories, McNeil, Elan Pharmaceutical, and Glaxo Wellcome."

Most recently, Dr. Fiore is currently receiving grant funding from Nabi Pharmaceuticals, which has a smoking cessation drug in the late stages of development. The drug is a nicotine vaccine which has been given fast track status by the FDA "for use as a therapeutic for smoking cessation."

It is unfortunate that with such severe conflicts of interest, Dr. Fiore was allowed to be in a position where these biases could affect national policy. He should never have been allowed to chair any committee making national recommendations for smoking cessation policy. Nor should anyone with similar financial conflicts have been allowed to serve on these panels.

But unfortunately, eight panelists of the group that made the 2008 recommendation to treat every smoker with drugs had financial conflicts of interest with Big Pharma.

Even more unfortunate is the fact that four of the members of the FDA's Tobacco Products Scientific Advisory Committee (TPSAC), including the committee chair, have similar financial conflicts of interest with Big Pharma. That committee is therefore in no position to be able to make objective scientific judgments about smoking cessation science or policy. The chances of an effective national approach to smoking cessation coming out of TPSAC are remote, given the financial-related biases of a good number of the committee members.

Sadly, we don't seem to be learning from our mistakes. Instead, we seem to be repeating them and even magnifying them.

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