Boston University School of Public Health Professor Michael Siegel has called for U.S. health officials and independent researchers to reassess the effectiveness of nicotine replacement therapy (NRT) and its role as the cornerstone of U.S. quit smoking policy. His call follows a rare glimpse of blinding integrity assessment results, from inside a nicotine patch study by the patch’s co-inventor, which disclosed that four times as many participants correctly identified randomized assignment to the placebo patch as incorrectly identified assignment to the nicotine patch.
by John R. Polito
Professor Michael Siegel, who is also a physician, today serves as the unelected and unappointed head of the tobacco control movement’s internal affairs division. His constant watch-dog fact checking and relentless insistence that the movement be driven by science, not profits, financial influence, exaggeration, or revenge, has endeared him to few. It looks like things are about to get worse.
Dr. Siegel is calling for scientific investigation into the use of placebo controls in nicotine replacement therapy (NRT) clinical trials. He wants those conducting the research to not have any pharmaceutical industry financial ties. He calls for new quitting studies that, for the first, force NRT users to compete head-to-head with real cold turkey quitters, not quitters who joined the study seeking free replacement nicotine but instead received a placebo.
Should the Obama Administration give voice to Dr. Siegel’s call, U.S. smoking cessation policy could see dramatic change, with pharm industry profits from the sale of NRT taking a serious blow.
Dr. Siegel’s call for an investigation of NRT, at his site entitled “The Rest of the Story,” opens by stating, 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.
He notes that current U.S. cessation policy (whose latest revision was reviewed by WhyQuit in May 2008) recommends that “NRT or other pharmaceutical agents be used with every smoker who wishes to quit” and is “plagued by a number of serious problems.” Dr. Siegel then lays out ten points, containing links to prior blogs, which highlight the 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.
Whyquit