Coakely Health Report
February 22, 2012 – UK quit smoking campaigns come under fire February 22, 2012 – 10:07 am, by Melissa Sweet Quit smoking campaigns in the UK that promote nicotine replacement therapies (NRT) are wrong to discourage the “cold turkey” approach, and could learn a lesson from Australian efforts, suggests Simon Chapman, professor of public health at the University of Sydney. ***
Raising questions about the medicalisation of smoking cessation Professor Simon Chapman writes: Two current UK government campaigns pull no punches about urging all smokers trying to quit to use drugs. One puts it bluntly: “Don’t go cold turkey”. Another poster on display in the nation’s waiting rooms says: “There are some people who can go cold turkey and stop smoking. But there aren’t many of them.” (See picture at bottom of this post.) That statement is manifestly incorrect and an enquiry should be undertaken into how such nonsense was approved for publication. In 1986, just a few years after nicotine replacement therapies became available, the American Cancer Society stated: “Over 90% of the estimated 37 million people who have stopped smoking in this country since the Surgeon General’s first report linking smoking to cancer [1964] have done so unaided.” How did they possibly manage to do it without drugs? We have long known that if you survey ex-smokers and ask them what strategy they used on their final, successful quit attempt, around two-thirds to three quarters answer “cold turkey”.
This was the case in the early days of NRT, and it remains so today. In a national US survey of 29,537 smokers, of those who had quit in the past 12 months for more than 4 weeks, unassisted cessation produced more than double the number of successes than all other methods combined. Yet it continues to be denigrated by those promoting pharmaceuticals as having the worst success rate. But the notion of the quitting “attempt” requires careful scrutiny. Millions around the world make quit attempts each year. Some are serious attempts, but others are half-hearted, brief and quickly forgotten. Mainly of these “attempts” barely deserve the name, so if they are entered into success estimates, unassisted cessation can appear to do badly. The much-telegraphed claim that pharmaceutically-assisted cessation doubles or triples your chances of quitting derives from a large bedrock of clinical trial data. But there are important differences between trying to quit when in a clinical trial and being a smoker trying to quit out in the “real world”.
Some examples: •Trialists have frequent contact with researchers trained in cohort retention. This creates Hawthorne effects (effects caused by the attention paid to you when being researched); •Trial participants are unrepresentative of the general population •Cessation trials exclude many people, including light smokers and those with mental health problems who are heavily over-represented among smokers. This removes many “hard cases”, flattering clinical trial effects. •Trialists complete their drug courses far more than in real world use •NRT trials have poor blindness integrity. Over half of studies in one review showed trial participants were significantly more likely than chance to accurately guess that they were allocated to the placebo arm, meaning that their faith in the treatment they received was likely to be poor. This would tend to exaggerate the differences between placebo and active NRT.
All of these combine to produce inflated success rates in trials that are often not reflected in real world quitting. An important illustration of this has just been published in the British Medical Journal’s Tobacco Control. The study examined an important simple question likely to be on the minds of many wanting to quit: if you follow a group of smokers who have quit smoking using different methods for two years after they have stopped, which method produced the best long-term quit rates? The Massachusetts study found that after two years, those who used NRT to quit had relapsed at the same rate as those who quit on their own. This has caused a storm among smoking cessation leaders, many of whom have long histories of engagement with pharmaceutical companies. (One review showed that industry sponsored trials produce better outcomes than those conducted without ties). But none of the reactions are so revealing as that from the Association for the Treatment of Tobacco Use and Dependence, representing nearly 450 tobacco treatment specialists.
Their statement emphasized two arguments. The first acknowledged that in population studies of cessation (as opposed to clinical trials): “Studies have shown that those who chose to use NRT have more past failures, more dependence, etc. and thus should [their emphasis] have lower quit rates. This bias, in which the more severely-ill subjects receive a treatment and the less-ill do not is known as “indication bias.” This is a clear admission that those who chose to use NRT in real world quit attempts often have poorer quit success than those who try to quit unaided. But their second argument contains a truly remarkable admission. They write that: NRT “is currently marketed for short-term use as an aid to smoking cessation. Over 100 randomized studies have found NRT increases short term abstinence and in these studies, after NRT has stopped the rate of relapse back to smoking does not differ from that of smokers who quit without treatment. The benefit of treatment is of increasing the initial quit rates [their emphasis] not preventing relapse.
Studying relapse rates in smokers several months after stopping NRT does not constitute the indictment of these aids that it might at first appear. Instead, it is like studying whether those who used penicillin sometime in the last year are less likely to have infections in the following year.” In other words, if you use NRT over the recommended period (typically 12 weeks) you have no better chance of stopping permanently than if you try to quit on your own. This is a frank admission that NRT offers little long term cessation advantage if you take it for three months. It therefore seems certain to herald the promotion of NRT for longer term maintenance. The American Cancer Council has already said: “we need … to convince the FDA that 12 weeks is not long enough for NRT to be maximally effective.” The pharmaceutical industry must already be counting its money.
Meanwhile, unassisted cessation continues to deliver more ex-smokers than those produced by pharmaceuticals, a fact that is treated almost like heresy by those committed to medicalising the process. In Australia, GP Colin Mendelsohn, writing for the Australian Association of Smoking Cessation Professionals, makes the same point, writing in Australian Doctor magazine that “the authors have confused effectiveness of treatment with relapse prevention.” Again an admission that NRT should not be expected to actually stop you smoking for good: it just gets you to stop for a little while, apparently. In Australia, now with only 15.1% of those aged 14+ smoking daily, the government is running a refreshingly original television campaign. Instead of the UK-style, long-faced “it will be so hard … don’t go cold turkey .. you’re unlikely to do it without drugs”, Australian smokers are seeing a positive “practice makes perfect”, “you can do it on your own too” approach. • Simon Chapman is professor of public health at the University of Sydney, and edited the BMJ’s Tobacco Control for 17 years. 10:07 am, by Melissa Sweet Quit smoking campaigns in the UK that promote nicotine replacement therapies (NRT) are wrong to discourage the “cold turkey” approach, and could learn a lesson from Australian efforts, suggests Simon Chapman, professor of public health at the University of Sydney. ***
Raising questions about the medicalisation of smoking cessation Professor Simon Chapman writes: Two current UK government campaigns pull no punches about urging all smokers trying to quit to use drugs. One puts it bluntly: “Don’t go cold turkey”. Another poster on display in the nation’s waiting rooms says: “There are some people who can go cold turkey and stop smoking. But there aren’t many of them.” (See picture at bottom of this post.) That statement is manifestly incorrect and an enquiry should be undertaken into how such nonsense was approved for publication. In 1986, just a few years after nicotine replacement therapies became available, the American Cancer Society stated: “Over 90% of the estimated 37 million people who have stopped smoking in this country since the Surgeon General’s first report linking smoking to cancer [1964] have done so unaided.” How did they possibly manage to do it without drugs? We have long known that if you survey ex-smokers and ask them what strategy they used on their final, successful quit attempt, around two-thirds to three quarters answer “cold turkey”. This was the case in the early days of NRT, and it remains so today. In a national US survey of 29,537 smokers, of those who had quit in the past 12 months for more than 4 weeks, unassisted cessation produced more than double the number of successes than all other methods combined.
Yet it continues to be denigrated by those promoting pharmaceuticals as having the worst success rate. But the notion of the quitting “attempt” requires careful scrutiny. Millions around the world make quit attempts each year. Some are serious attempts, but others are half-hearted, brief and quickly forgotten. Mainly of these “attempts” barely deserve the name, so if they are entered into success estimates, unassisted cessation can appear to do badly. The much-telegraphed claim that pharmaceutically-assisted cessation doubles or triples your chances of quitting derives from a large bedrock of clinical trial data. But there are important differences between trying to quit when in a clinical trial and being a smoker trying to quit out in the “real world”.
Some examples: •Trialists have frequent contact with researchers trained in cohort retention. This creates Hawthorne effects (effects caused by the attention paid to you when being researched); •Trial participants are unrepresentative of the general population •Cessation trials exclude many people, including light smokers and those with mental health problems who are heavily over-represented among smokers. This removes many “hard cases”, flattering clinical trial effects. •Trialists complete their drug courses far more than in real world use •NRT trials have poor blindness integrity. Over half of studies in one review showed trial participants were significantly more likely than chance to accurately guess that they were allocated to the placebo arm, meaning that their faith in the treatment they received was likely to be poor. This would tend to exaggerate the differences between placebo and active NRT. All of these combine to produce inflated success rates in trials that are often not reflected in real world quitting. An important illustration of this has just been published in the British Medical Journal’s Tobacco Control. The study examined an important simple question likely to be on the minds of many wanting to quit: if you follow a group of smokers who have quit smoking using different methods for two years after they have stopped, which method produced the best long-term quit rates?
The Massachusetts study found that after two years, those who used NRT to quit had relapsed at the same rate as those who quit on their own. This has caused a storm among smoking cessation leaders, many of whom have long histories of engagement with pharmaceutical companies. (One review showed that industry sponsored trials produce better outcomes than those conducted without ties). But none of the reactions are so revealing as that from the Association for the Treatment of Tobacco Use and Dependence, representing nearly 450 tobacco treatment specialists. Their statement emphasized two arguments. The first acknowledged that in population studies of cessation (as opposed to clinical trials): “Studies have shown that those who chose to use NRT have more past failures, more dependence, etc. and thus should [their emphasis] have lower quit rates. This bias, in which the more severely-ill subjects receive a treatment and the less-ill do not is known as “indication bias.” This is a clear admission that those who chose to use NRT in real world quit attempts often have poorer quit success than those who try to quit unaided. But their second argument contains a truly remarkable admission.
They write that: NRT “is currently marketed for short-term use as an aid to smoking cessation. Over 100 randomized studies have found NRT increases short term abstinence and in these studies, after NRT has stopped the rate of relapse back to smoking does not differ from that of smokers who quit without treatment. The benefit of treatment is of increasing the initial quit rates [their emphasis] not preventing relapse. Studying relapse rates in smokers several months after stopping NRT does not constitute the indictment of these aids that it might at first appear. Instead, it is like studying whether those who used penicillin sometime in the last year are less likely to have infections in the following year.” In other words, if you use NRT over the recommended period (typically 12 weeks) you have no better chance of stopping permanently than if you try to quit on your own.
This is a frank admission that NRT offers little long term cessation advantage if you take it for three months. It therefore seems certain to herald the promotion of NRT for longer term maintenance. The American Cancer Council has already said: “we need … to convince the FDA that 12 weeks is not long enough for NRT to be maximally effective.” The pharmaceutical industry must already be counting its money. Meanwhile, unassisted cessation continues to deliver more ex-smokers than those produced by pharmaceuticals, a fact that is treated almost like heresy by those committed to medicalising the process. In Australia, GP Colin Mendelsohn, writing for the Australian Association of Smoking Cessation Professionals, makes the same point, writing in Australian Doctor magazine that “the authors have confused effectiveness of treatment with relapse prevention.” Again an admission that NRT should not be expected to actually stop you smoking for good: it just gets you to stop for a little while, apparently. In Australia, now with only 15.1% of those aged 14+ smoking daily, the government is running a refreshingly original television campaign.
Instead of the UK-style, long-faced “it will be so hard … don’t go cold turkey .. you’re unlikely to do it without drugs”, Australian smokers are seeing a positive “practice makes perfect”, “you can do it on your own too” approach. • Simon Chapman is professor of public health at the University of Sydney, and edited the BMJ’s Tobacco Control for 17 years.