Tobacco control integrity champion demands
review of U.S. smoking cessation policy
Boston University School of Public Health Professor Michael Siegel yesterday 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, revealed in a disturbing 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.
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.
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.
Dr. Siegel concludes by stating, "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."
Need for Unconflicted Researchers
"Most importantly," he says, "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."
But as Dr. Siegel himself is forced to acknowledge, "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.
U.S. health officials assert that smoking is our nation's leading cause of premature death. If true, and almost all U.S. smoking cessation researchers have already been heavily conflicted by pharmaceutical industry financial ties, then how do we obtain the independent research that America can trust? The solution could rest in U.S. health officials using existing NIH research funding to hire fresh, new researchers.
But are senior health officials alarmed enough? Are they troubled by the fact that nearly all real-world quitting method surveys report cold turkey as the winner? Does it disturb them that although nearly all clinical trials conclude that NRT doubles cessation rates, that the U.S. smoking rate has remained almost unchanged since June 2000? Do they appreciate that it was then that the U.S. cessation policy effectively tied health agency hands and forbid them from openly aiding, supporting, counseling and encouraging what, by far, continues to be our nation's most productive quitting method, cold turkey?
Will Kathleen Sebelius, Secretary of the Department of Health and Human Services, demand that national quit smoking policy be driven by science not profits? Will the National Institute of Health demand integrity and common sense in clinical trial research funded by the U.S. government? Will the Agency for Healthcare Research and Quality (AHRQ), the agency responsible for identifying and featuring the most reliable smoking cessation evidence available, end the practice of allowing U.S. cessation policy to authored by expert panels heavily influenced by pharmaceutical industry financial ties?
Will current AHRQ Director Carolyn M. Clancy, M.D., again permit the next panel chairman to also be receiving a $50,000 a year annual endowment funded by the company that sells Nicorette, or has she changed her thinking since President Obama was elected? Will Centers for Disease Control Director Thomas R. Frieden, MD, MPH, soon require the CDC's Office on Smoking and Health (OSH) to ensure that the 80 to 90% of U.S. quitters attempting to quit cold turkey are encouraged, not discouraged, in trusting their natural quitting instincts?
I close with a glaring example of government deception in bashing the nation's most effective quitting method. The only known government quit smoking method survey, conducted by the National Cancer Institute (NCI), was never published. Why? It was not published because its findings are contrary to all government advice on how to quit.
In discussing quitting method options, Page 10 of the NCI's October 2008 how to quit booklet "Clearing the Air" (PDF page 12) contains a section labeled "Cold Turkey." It tells readers, "For some smokers, "going cold turkey" seems like the easiest way to quit: Just stop smoking and tell yourself you'll never light up again. This works for some smokers - usually those with the lowest level of nicotine dependence - but not many. Fewer than 5 percent of smokers can quit this way." "Research shows that most smokers have more success with one of the assisted quit methods discussed below."
A February 8, 2007 font-page Wall Street Journal article entitled "NICOTINE FIX - Behind Antismoking Policy, Influence of Drug Industry" featured a 2006 NCI quitting method survey that found a 9 month cold turkey quit smoking rate of 16%, more than three times higher than its quitting book, Clearing the Air, asserts. It also shows that those quitting without resort to the nicotine patch, lozenge or Zyban actually did better at six months that those using them.
Will the National Cancer Institute begin giving greater weight to the government's own real-world effectiveness findings or continue to hide government studies while pushing placebo-controlled clinical trial efficacy findings that he knows were not blind? Will the NCI continue its campaign to destroy quitter confidence in our nation's most productive and effective quitting method?
Can science prevail over corporate profits, researcher financial interests, and the group think their placebo-controlled clinical efficacy findings have fostered? Will it? Only time will tell.
- Cold turkey clobbers e-cigs, NRT and Chantix, John R. Polito, 07/18/18
- JNCI study finds pharmaceutical stop smoking aids ineffective, John R. Polito, 12/22/17
- Nicotine cessation: lost in the deserts of Abu Dhabi, John R. Polito, 03/16/15
- 10 studies screaming "leave replacement nicotine alone!" John R. Polito, 01/01/15
- The Surgeon General's Reports: 50 years of cessation ignorance, John R. Polito, 01/20/14
- Australia's half-baked quit smoking campaign, John R. Polito, 11/3013
- The Great American quit smoking sham, John R. Polito, 11/18/13
- BMJ's non-publication policy should extend to pharma's nicotine, John R. Polito, 10/19/13
- Gallup Poll: cold turkey 48 times smarter than Nicorette, John R. Polito, 08/26/13
- Cold turkey quitting still king, John R. Polito, 07/15/13
- Pharma bias destroys ITC quit smoking medication study, John R. Polito, 08/20/12
- Potent warnings, horrible quitting advice: what's the CDC smoking? John R. Polito, 03/17/12
- Replacement Nicotine's Killing Fields, John R. Polito, 02/11/12
- Chantix study joins negative findings omissions club, John R. Polito, 12/22/11
- Dying truths about quitting smoking methods, John R. Polito, 11/14/11
- Bias against cold turkey quitting apparent in literature, Dr. Michael Siegel, 11/03/11
- Suicidal behavior and depression in smoking cessation treatments, Moore TJ et al, 11/03/11
- Study finds cold turkey quitting more effective but concludes opposite, Dr. Michael Siegel, 11/01/11
- Tar wars over smoking cessation, BMJ Link, Professor Simon Chapman, 08/08/11
- Is a 14% Chantix success rate worth risking death?, John R. Polito, 06/14/11
- Chantix fails to defeat nicotine patch, John R. Polito, 03/30/11
- Chantix serious injuries exceed 8,500, John R. Polito, 01/28/11
- Champix - Chantix worth questioned - John R. Polito, 01/06/11
- GlaxoSmithKline Continues Defrauding Smokers - John R. Polito, 11/02/10
- Little communication in failed war against smoking - John R. Polito, 08/08/10
- Smokefree.gov really Buymeds.now - John R. Polito, 03/24/10
- Five facts Chantix ads keep hidden - John R. Polito, 12/29/09
- Pfizer's Chantix Continues Killing Quitters - John R. Polito, 10/22/08
- Chantix and Champix mental health safety assurances contrary to evidence - John R. Polito, 06/12/08
- Chantix blamed for 3,063 serious injuries and 78 deaths - John R. Polito, 05/13/08
- Strong Safety Signal Seen for New Varenicline Risks - ISMP, 05/21/08
- U.S. quit smoking policy integrity drowns in pharmaceutical influence - John R. Polito, 05/13/08
- Does updated tobacco treatment "Guideline" reflect sham science? - John R. Polito, 05/05/08
- FDA pulls video clip admitting Chantix suicide link - John R. Polito, 04/03/08
- New FDA Chantix suicide risk video clip raises concerns - John R. Polito, 04/02/08
- FDA Chantix Handling Betrayed Public Health - John R. Polito, 02/08
- Windows media clip of WhyQuit's candid views on Chantix & Champix: 18mb video for dial-up users | high res 53mb format | and 7mb audio only format, length 48 minutes, recorded 10/19/07 by Joel Spitzer
- Can Chantix Cause Depression? - The People's Pharmacy, 09/19/07
- Flawed research equates placebo to cold turkey - John R. Polito, 03/07
- Nicotine Fix - Behind Antismoking Policy, Influence of Drug Industry - Kevin Helliker, 02/07
- WSJ Highlights Financial Conflicts of Chair of Federal Guidelines Panel - Michael Siegel, MD 02/07
- Nixing the Patch: Smokers quit cold turkey - Ken Millstone, 02/07
- New Study Challenges Thinking on Use of NRT During Pregnancy - Michael Siegel, MD, 02/07
- Nicotine for the Fetus, the Infant and Adolescent - H.K. Ginzel, MD, 02/07
- The secret to quitting smoking - John R. Polito, 01/07
- Financial Ties Between Guideline Panels and Big Pharma Run Deep - Michael Siegel, MD, 01/07
- Chantix - an 8 in 10 failure rate or worse? - John R. Polito, 12/06
- Do physician's have a legal duty to ignore Guideline Recommendation 7? - John R. Polito, 12/06
- Is the U.S. government's quitting policy killing smokers? - John R. Polito, 10/06
- Will Chantix really help me quit smoking? - John R. Polito, 08/06
- Conference Sponsorship by Pharma Precludes Objective Symposium - Michael Siegel, MD 07/06
- 13th World Conference on Tobacco or Health Drenched in Nicotine - John R. Polito, 07/06
- Cold Turkey Twice as Effective as NRT or Zyban - John R. Polito, 05/06
- Nicotine Not Medicine, Its Use Not Therapy - John R. Polito, 04/06
- GlaxoSmithKline Attacks Cold Turkey Quitting - John R. Polito, 12/05
- UK Guidance for NRT use in pregnancy and by children - ASH London, 12/05
- June 2000 Guideline Chairman Michael Fiore's Testimony - see PDF pages 14 & 15, 05/05
- The Nicotine Patch, Gum and Lozenge - Mounting Evidence of a Sham - John R. Polito, 04/05
- 40 Years of Progress? - Joel Spitzer, 10/04
- Widespread Blinding Failures Put NRT Studies in Serious Question - John R. Polito, 06/04
- Nicotine Gum Maker's Concern Raises Concerns - John R. Polito, 05/04
- A Quitter's Dilemma: Hooked on the Cure - New York Times, 05/04
- Quebec CT Quitters Disprove "Double Your Chances" NRT Assertion - John R. Polito, 04/04
- Are nicotine weaning products a bad joke? - John R. Polito, 10/03
- Is CT Quitting More Productive & Effective than NRT? - John R. Polito, 07/03
- Are Teens Getting Hooked on NRT? - John R. Polito, 06/03
- March 2003 OTC NRT Meta-Analysis Finds 93% Midyear Relapse Rate - John R. Polito, 03/03
- Quitting Methods - Who to Believe? - Joel Spitzer, 2003
- JAMA Study Concludes NRT is Ineffective - John R. Polito, 09/02
- Real-World Nicotine Patch and Gum Rates - John R. Polito, 06/02
- Does the OTC Nicotine Patch Really Double Your Chances of Quitting? - John R. Polito, 04/02
- Is Nicotine Replacement Therapy The Smoker's Last Best Hope? - John R. Polito, 11/00
- Financial Disclosures for June 2000 Guideline Panel - U.S. Public Health Service, 06/00
- June 2000 Guideline Recommendation 7 - pharmacotherapy use by all quitters - 06/00
How to Quit Smoking
Our Free E-books
Read both & destroy fear driven anxieties!
Discover Smart Turkey Quitting
- WhyQuit.com - WhyQuit is the Internet's oldest forum devoted to the art, science and psychology of cold turkey quitting, the stop smoking method used by the vast majority of all successful long-term ex-smokers.
- Nicotine Addiction 101 - WhyQuit's basic guide to understanding nicotine dependency.
- Nicotine Cessation Topic Index - An alphabetical subject matter index to more than a thousand nicotine cessation articles, videos and support group discussions.
- Joel's Library - Joel Spitzer began presenting stop smoking clinics and seminars in 1976. WhyQuit's education director since 2000, Joel's Library is home to his life's work. It includes Joel's "Daily Quitting Lesson Guide," more than 100 original stop smoking articles, his free ebook "Never Take Another Puff," and to his ever growing collection of more than 400 stop smoking videos.
- "Freedom from Nicotine - The Journey Home" - Written by John R. Polito, a former 30-year heavy smoker and WhyQuit's 1999 founder, Freedom from Nicotine shares the science underlying nicotine dependency and successful abrupt nicotine cessation.
- Turkeyville - Imagine surrounding yourself with more than 10,000 cold turkey quitters. Turkeyville is a Facebook support group exclusively for cold turkey quitters.
- Freedom - Freedom was WhyQuit's original 1999 stop smoking support group. No longer accepting members, its 453,000 archived posts continue to share recovery insights.