In light of yesterday's revelation (post #1; post #2) concerning the failure of the blinding in nicotine replacement therapy (NRT) trials, and also in light of the way in which financial conflicts of interest with pharmaceutical companies have resulted in bias in the reporting of the results of these studies, I think it is time for a re-examination of the effectiveness of NRT and its role as part of a national smoking cessation promotion strategy.
The current recommendation that NRT or other pharmaceutical agents be used with every smoker who wishes to quit is plagued by a number of serious problems:
1. The panel making this recommendation was heavily conflicted. Its chair and seven members had financial conflicts of interest with pharmaceutical companies that manufacture smoking cessation drugs.
2. The presentation of information to physicians on drug treatment for smoking cessation has been found to be biased, presumably because of these financial conflicts of interest.
3. The conclusions of a number of the individual studies of NRT therapy appear to be biased, also presumably on account of financial conflicts of interest. See also this post.
4. Reporting of the financial conflicts of interest in smoking cessation drug studies has been inadequate, making it even more difficult to uncover the role of bias in the reporting and review of this literature.
5. The use of NRT therapy during pregnancy has been specifically challenged.
6. Population-based studies indicate that cold turkey cessation, not the use of NRT, is the most effective method for smoking cessation.
7. A number of recent studies indicate that spontaneous quit attempts, usually conducted without the assistance of NRT, are more effective than planned quit attempts which commonly use NRT.
8. Smoking cessation treatment providers have an odd dislike of electronic cigarettes, suggesting that financial conflicts of interest are playing a major role in skewing the thinking on the issue of national smoking cessation strategy.
9. Blinding failure in NRT clinical trials is a serious concern and has not yet been adequately addressed. As a result, the conclusions of the existing literature have been thrown into doubt. See the following posts for more on this issue: post 1; post 2; post 3.
Blinding failure is a serious concern because when subjects enter into a clinical trial with the thought/hope that they are going to receive nicotine replacement and then they realize they are getting a dud, they may well become very disappointed and discouraged right away. Relapse is very likely under such circumstances. This immediately lowers the continuous abstinence rates in the placebo group. There may be some recovery but it is unlikely that this initial effect can be overcome.
10. Failure to compare NRT to cold turkey quitting: In order to credibly claim that NRT is effective, one needs to compare NRT not to placebo, but to cold turkey quitting.
The Rest of the Story
In light of these 10 problems, I believe that it is time for a serious re-examination of both the effectiveness of nicotine replacement therapy and the role of NRT as part of a national strategy for the promotion of smoking cessation.
Most importantly, this re-examination needs to be conducted by unconflicted researchers who do not have financial interests in pharmaceutical companies which stand to benefit from the recommended use of nicotine replacement products.
Unfortunately, the tobacco control field has become so intertwined with pharmaceutical company money -- even its national and international conferences are now sponsored by Big Pharma -- that I see little possibility for such an unconflicted re-examination of this issue to take place.