Thursday, September 29, 2016

Article Defending Nicotine Replacement Therapy Fails to Disclose Author's Conflict of Interest with Big Pharma

In another example that demonstrates the hidden influence of Big Pharma on tobacco treatment policy and the extent to which many defenders of nicotine replacement therapy (NRT) are going to hide their conflicts of interest, an article (letter to the editor/reply) defending NRT from criticism that was published online ahead of print in the Journal of Clinical Epidemiology fails to disclose the serious conflicts of interest of its lead author.

The article is a response to a paper published recently in the Journal which concludes that once one accounts for publication bias, there is no significant effect of NRT on smoking cessation.

The published article (a PDF of the accepted manuscript) does not disclose any conflicts of interest that the authors may have. There is no conflict of interest statement at all.

The Rest of the Story

The rest of the story is that the lead author has a long string of financial relationships with pharmaceutical companies, including some that manufacture drugs for smoking cessation, such as NRT.

In 2016, the lead author was the recipient of a Pfizer research award for the study of nicotine dependence. That announcement reports that he "has received consulting fees, honoraria and grants from several for-profit and non-profit organizations that develop smoking-cessation devices, medications, and services, including Pfizer."

The lead author's online CV acknowledges that he has performed consulting services for: "Abbot Laboratories,Acrux Ltd, ALZA Corporation, American Cynamid, Anesta, Aradigm, BASF/Knoll, Begbies Traynor; Boehringer-Ingelheim Pharmaceuticals, Celtic Pharmaceuticals, Ciba-Geigy, Cygnus, DynaGen Corporation, Elan/Sano, Eli Lilly Pharmaceuticals, Glaxo Wellcome, Dupont Merck Pharmaceuticals, Hoechst Marion Rouseau/Marion Merrell Dow/Merrell Dow Lakeside, Lederle Pharmaceuticals, McNeil Pharmaceutical/McNeil Consumer, Nabi, Inc, Neuromedical Technologies, Inc., Neuroscience Ventures, Pacific Pharmaceuticals, Parke Davis Pharmaceuticals, Pfizer Pharmaceuticals, Pharmacia & Upjohn/AB Leo Pharmaceuticals/Kabi Pharmacia/Pfizer, Proctor & Gamble, Sano Pharmaceuticals, Propagate Pharmaceuticals, Sanofi/Synthelabo Pharmaceuticals, SmithKlineBeecham/Glaxo SmithKline Consumer Healthcare, Xenova Limited."

The lead author reports (in the online CV) having received grants from Pfizer (Chantix), McNeil Pharmaceuticals (Nicotrol inhaler and nicotine nasal spray), Pharmacia & Upjohn/Smith Klein Beecham Healthcare (nicotine gum), ALZA (Nicoderm), Marion Merrell Dow (Nicorette), and DynaGen (NicErase). 

There doesn't appear to be any question that this author's financial conflicts of interest are hugely significant and highly relevant to the subject matter of the manuscript. Therefore, these conflicts of interest should have been disclosed in the published article so that readers can be aware of the conflicts and take that potential source of bias into consideration when evaluating the validity of the paper's conclusions.

It is not clear whether the failed disclosure in the published article is the fault of the authors or of the journal itself (i.e., it is possible that the authors disclosed these conflicts during the submission process but that the journal failed to add these disclosures to the published article). However, it doesn't matter because either way, readers are deprived of knowing about these important conflicts of interest. In addition, I believe it is the authors' obligation to ensure that the conflicts of interest are disclosed in the actual published paper. The authors are able to make such a correction when reviewing the manuscript proofs.

This is not the first example I have highlighted on this blog of the hiding of financial conflicts with Big Pharma in papers defending nicotine replacement therapy or other smoking cessation drugs. This is a general pattern I have observed. To me, it suggests that many defenders of NRT really do have something to hide. The evidence supporting NRT as a population-based strategy for smoking cessation is already flimsy, and it becomes even more flimsy once one considers the severe conflicts of interest of so many investigators who are evaluating these drugs. So it makes sense that there would be an effort to hide these conflicts from the public. But it is not an ethical practice, and it does a great disservice to the public and to the public's health.

(Thanks to John Polito for the tip.)

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