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P.S. On Nicotine Gum And Patches: This Study 'Shakes Up The Field'

You know the old joke: "I'm great at quitting smoking: I've done it more than a dozen times!" That's what I thought of when I saw the Harvard/UMass study earlier this week questioning the hundreds of millions of dollars spent on nicotine gum, patches and other forms of "nicotine replacement therapy."

I caught up a bit late with Boston University School of Public Health professor Michael Siegel, a leading tobacco control researcher whom I've seen quoted in the Boston Globe dozens of  times. So mea culpa for tardiness, but I still want to put his considered perspective on the record. Some of the coverage made it sound like the new study is just the latest salvo in a long debate over whether nicotine replacement therapy is worthwhile, but my impression from Prof. Siegel — who, granted, has long been a skeptic of nicotine replacement — is that this may be more of a game-changer.

His take on the study, lightly edited:

Strictly speaking, what this study looked at was smoking relapse. These were smokers who had quit, so from a strict perspective, this study can only conclude that nicotine replacement was not effective in helping prevent relapse.

[module align="right" width="half" type="pull-quote"]'In the field, generally there’s a dogma that nicotine replacement therapy is the state of the art.'[/module]

However, when you think about it, the smoking cessation process almost always involves relapse, so in a sense, you can infer from the study that nicotine replacement is not effective for quitting because quitting involves being sustained. If you took a bunch of quitters at a given time and you wanted to predict whether they were going to sustain their quitting, those on nicotine replacement therapy were no more likely to sustain their quitting. I do think that this study does provide evidence that in general, nicotine replacement therapy is not effective for quitting.

Is this new, did we know this? Yes and no.

No, in that in the field, generally there’s a dogma that nicotine replacement therapy is the state of the art. 'This is the best we have and this is the standard treatment that’s used.' There were a minority of people within the tobacco field — one of which is me — who have been arguing that the scientific evidence does not support this. If you look at population-based studies, they show that these products are just not effective.

So the difference in the research is that if you look at clinical trials that test individual users to see whether or not provision of nicotine replacement therapy is effective, these studies tend to find a small effect. The problem is that if you look overall in the population, and ask successful quitters, 'How did you quit?' they almost never say 'With nicotine replacement therapy.' There's a discrepancy in the findings.

So this paper is really important because I think it shows quite conclusively, in a large sample over many years, that if you really look at the long term, nicotine replacement therapy is not doing anything.

[module align="left" width="half" type="pull-quote"]Ask successful quitters, 'How did you quit?' they almost never say 'With nicotine replacement therapy.'[/module]

The problem is that most of these clinical trials are short-term studies --- they follow people for three or six months or at most for one year — and if you look at such a short time they are more effective than placebo. But this study is showing that if you look over a sustained period of time, which is what really matters, this nicotine replacement is no more effective than just quitting on your own.

I think this is going to be one of the most important studies in a long time. I think this really shakes up the field, and hopefully will wake people up and wake the field up. The reason it’s so important is: How do we spend our money? Where do we put our focus in tobacco control?

The implications of this study are not that we should tell doctors not to prescribe nicotine replacement therapy. That's not why this is important. The reason it's important is that at a larger level, when the department of health or other agencies spend money, one of the main ways it's being spent is providing free nicotine replacement therapy for smokers, and what this suggests is that that's a waste of money.

The study tells us that we have to use the methods we know work: aggressive anti-smoking advertising campaigns; increasing the prices of cigarettes; and extending smoking bans in bars and restaurants and other workplaces. These are things we know work, and we need to stick with the bread and butter of tobacco control.

This program aired on January 11, 2012. The audio for this program is not available.

Carey Goldberg Twitter Editor, CommonHealth
Carey Goldberg is the editor of WBUR's CommonHealth blog.

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