Non-publication policy should extend to pharma's nicotine
19 October 2013
While BMJ, Heart, Thorax and BMJ Open are to be applauded for their new non-publication policy regarding nicotine industry funded research, in my opinion the policy should extend to all pharmaceutical industry funded cessation studies too. What is the proximate cause of most smoking related deaths, smoking or a quitting industry that falsely teaches nicotine addicts that nicotine is medicine, its use therapy, and that it doubles their chances?
For while replacement nicotine (NRT) demonstrates clinical efficacy over placebo, it has consistently proven totally ineffective in population level quitting. Forty years and billions spent on marketing, yet only 1 in 100 U.S. ex-smokers credit nicotine gum for their success, with all approved products combined accounting for only 8 percent of successful cessation. How much closer to consumer fraud can approved products possibly get? I submit that the tail is killing the dog.
One would think that medical journals would care whether or not a placebo-controlled quitting study labeled as having been blind, actually was blind. Mooney et al's 2004 cessation blinding integrity review found that studies were generally not blind as claimed, as subjects accurately judged treatment assignment at rates significantly above chance. Mooney warned that studies should uniformly test the integrity of study blinding or risk having the study's validity questioned, advice that all but a few studies have ignored.
Blinding concerns were so horrific that nicotine gum and patch studies resorted to use of active placebos containing small amounts of nicotine for at least 15 years. Since 2004 journal editors have ignored Mooney and the fact that 3-4 times as many placebo group members are able to accurately declare their assignment as guess wrong, and should be expected to so within 24 to 48 hours of quitting (peak withdrawal).
Reflect on the legitimacy of quitting studies that compared someone who had ended use of an addictive substance to someone who had not, where the primary initial counseling offered was often how to successfully transfer to a new form of nicotine delivery, not how to survive abrupt nicotine cessation, where "therapy" was normally awarded full credit when the patch was ripped off after a single day's use, and where hundreds of quitting studies had nothing whatsoever to do with arresting chemical dependency upon nicotine, as body fluids where almost never examined.
I submit that pharma's financial influence has destroyed smoking cessation. I submit that medical journals, peer review and journal editors share culpability.
With NRT now being marketed as an aid to smoking, for those times when smoking isn't convenient, I beg all journal editors to refuse to publish placebo-controlled cessation studies unless provided proof that the study measured efficacy not expectations and frustrations.
 Doran CM, Valenti L, Robinson M, Britt H, Mattick RP. Smoking status of Australian general practice patients and their attempts to quit. Addict Behav 2006;31:758-66, http://www.ncbi.nlm.nih.gov/pubmed/16137834 and Pierce JP, Cummins SE, White MM, Humphrey A, Messer K, Quitlines and Nicotine Replacement for Smoking Cessation: Do We Need to Change Policy?, Annu. Rev. Public Health 2012. 33:12.1–12.16, http://www.ncbi.nlm.nih.gov/pubmed/22224888
 Gallup. Most U.S. smokers want to quit, have tried multiple times. July 31, 2013. http://www.gallup.com/poll/163763/smokers-quit-tried-multiple-times.aspx
 Mooney M, White T, Hatsukami D. The blind spot in the nicotine replacement therapy literature: assessment of the double-blind in clinical trials. Addict Behav 2004;29:673-84, http://www.ncbi.nlm.nih.gov/pubmed/15135549
 Jarvis MJ, Raw M, Russell MA and Feyerabend C, Randomised controlled trial of nicotine chewing-gum, Br Med J (Clin Res Ed). 1982 August 21; 285(6341): 537–40, http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1499070 ; Sønderskov J, Olsen J, Sabroe S, Meillier L, Overvad K, Nicotine patches in smoking cessation: a randomized trial among over-the-counter customers in Denmark, Am J Epidemiol. 1997 Feb 15;145(4):309-18 at page 312, http://aje.oxfordjournals.org/content/145/4/309.long ; and Campbell IA, Prescott RJ, Tjeder-Burton SM, Transdermal nicotine plus support in patients attending hospital with smoking-related diseases: a placebo-controlled study, Respir Med. 1996 Jan;90(1):47-51, at page 48 "Patients in the P [placebo] group received a transdermal formulation with a very low content of nicotine (13% of the active form), a dose which is conventionally felt to be too low to affect outcome." http://www.ncbi.nlm.nih.gov/pubmed/8857326
 Rose JE, Herskovic JE, Behm FM, Westman EC, Precessation treatment with nicotine patch significantly increases abstinence rates relative to conventional treatment.Nicotine Tob Res. 2009 Sep;11(9):1067-75. doi: 10.1093/ntr/ntp103. Epub 2009 Jun 30.
"of 165 subjects receiving placebo patches, 27 believed they had received active patches, 112 believed they had not, and 26 were unsure", http://www.ncbi.nlm.nih.gov/pubmed/19567826 ; Dar R, Stronguin F, Etter JF. Assigned versus perceived placebo effects in nicotine replacement therapy for smoking reduction in Swiss smokers. J Consult Clin Psychol 2005;73:350-3, 3.3 times as many placebo group members correctly guessed that they had received placebo (54.5%) as guess nicotine (16.4%), http://www.ncbi.nlm.nih.gov/pubmed/15796644 ; Tønnesen P, Nørregaard J, Mikkelsen K, Jørgensen S, Nilsson F., A double-blind trial of a nicotine inhaler for smoking cessation, JAMA. 1993 Mar 10;269(10):1268-71, Tonnesen responding to email indicated that 3.8 times as many in the placebo group correctly guessed placebo (58%) as guessed nicotine (15%). Among inhaler users, Tonnesen found that 3.5 times more correctly guessed inhaler (46%) as guessed placebo (13%), while 42% on active and 27% on placebo did not know which treatment they had received, http://www.ncbi.nlm.nih.gov/pubmed/8437304
Competing interests: Pro bono director of abrupt nicotine cessation websites and author of a nicotine cessation book.
Director WhyQuit.com, 106 Aldrich Place, Goose Creek, SC 29445 USA
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