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Does updated tobacco treatment "Guideline" reflect sham science?

by John R. Polito, Editor WhyQuit

May 5, 2008

It appears that pharmaceutical influence continues to own official U.S. smoking cessation policy. According to an advance agenda, the newest U.S. policy pronouncement will be unveiled Wednesday, May 7, at 9 a.m. in room 3C at AMA headquarters located at 515 North State Street, Chicago. The revision panel's controversial chairman, Dr. Michael C. Fiore, whose significant financial ties to the pharmaceutical quit smoking product industry made front-page ethics news in the Wall Street Journal on February 7, 2007, is scheduled to summarize "findings and recommendations" from the 2008 update of the U.S. Guideline for Treating Tobacco Use and Dependence.

According to an advance summary, as in 2000, Dr. Fiore will reveal that it is the Guideline's recommendation that, with few exceptions, "clinicians should encourage" pharmaceutical quitting product "use by all patients attempting to quit smoking." While this cessation quitting method monopoly will generate billions in pharmaceutical industry profits, does it serve public health?

Sadly, what should and could have been a national resource and treasure in helping teach physicians what is not taught in most medical schools, how to effectively counsel patient's to quit smoking, is instead little more than a glorified pharmaceutical quitting product guide and sales advertisement.

Recommendation 5 of the April 1996 Guideline presented nicotine replacement as a co-equal option to counseling, skills development and support (see PDF page 5), which had served as the historic cornerstone of abrupt nicotine cessation quitting programs. But pharmaceutical interests grew aggressive.

Recommendation 7 of the June 2000 Clinical Practice Guideline, also chaired by Dr. Fiore, totally consumed all other recommendations. It declared that, "Numerous effective pharmacotherapies for smoking cessation now exist. Except in the presence of contraindications, these should be used with ALL patients attempting to quit smoking" (see PDF pages 4 and 18).

An advance copy of Wednesday's recommendations indicates that recommendations 3, 6 and 7 will combine to continue to effectively destroy the legitimacy and prevent government backing of any and all non-pharmacology quitting programs, programs relying upon education, counseling, skills development, motivation and/or support.

While the May 2008 Guideline strongly encourages "counseling" it refuses to allow it unless accompanied by "medication." This is not a question of scientific study evidence. It is a question of policy, policy gone astray. A stroke of capitalistic genesis, it is a campaign guaranteed to make the pharmaceutical industry billions by using official government policy to criticize, belittle, isolate, marginalize and destroy competition.

We've watched as pharmacology commercials have repeatedly suggested that quitting without it is nearly impossible, when in truth, the vast majority of successful quitters during 2008 will quit cold turkey. We've watched nicotine patch and gum commercials suggest that they make quitting "easy" when research by GlaxoSmithKline's own consultants indicates that 93% of OTC NRT study participants relapsed to smoking within 6 months.

Wednesday is a golden opportunity for health journalists to at last ask the tough questions. But will they? With roughly 40% of U.S. smokers making a serious quitting attempt during 2008, with the latest cure - Chantix - asking smokers to assume risk of death, with decline in the U.S. smoking rate having ground to a halt, those addicted to smoking nicotine deserve answers. But will they get them? Below are a few questions deserving of answers:

  1. Dr. Fiore, what quitting method will be responsible for generating the most quitters during 2008 and roughly how many quitters is it expected to generate?

  2. If the number of successful cold turkey quitters during 2008 will vastly exceed those of all other quitting methods combined, why outlaw, via official policy, programs designed to educate, counsel and support non-pharmacology quitters?

  3. If cold turkey quitting produces far more successful long-term quitters than all other quitting methods combined, then why, Dr. Fiore, have you assembled an "expert" panel void of any "expert" who today teaches, counsels and supports non-pharmacology quitting?

  4. Dr. Fiore, in that you repeatedly admitted that cold turkey is today the most productive quitting method, your beef must be that its effectiveness is low. If true, please point to the chapter in the U.S. Guideline where you share the knowledge and teach the skills needed to enhance cold turkey quitting rates. It's a little hard to do when you have zero experience in educating and supporting cold turkey quitters, isn't it?

  5. How many times does the Guideline mention quitting cold turkey? Is the reference positive or negative? Dr. Fiore, do you ever once share with physicians the fact that today, in 2008, the vast majority of successful quitters will quit smoking cold turkey? Why keep it secret?

  6. Dr. Fiore, did the panel consider real-world pharmaceutical product performance findings important? If so, why does the revised Guideline fail to inform physicians that a September 2002 JAMA study analyzing California quitting survey data found NRT ineffective? Why ignore the National Cancer Institute's 2006 survey that found quitting without NRT or Zyban more effective than quitting with them? What about the 2006 Australian survey which found cold turkey twice as effective as pharmacology among patients of family practice physicians? Dr. Fiore, do you really believe that the average smoker cannot be trusted to accurately remember their last quitting attempt, whether successful and the method used? If so, where is your proof?

  7. An April 16, 2008 study of four week quitting rates achieved by England's NHS (National Health Service) Stop Smoking Services, a program offering individual and group counseling and support, found that while 51% quitting without use of any quitting product were still smoke-free -- some 14,533 strong -- that only 48% of NRT quitters were still not smoking [also see similar UK NHS SSS findings from 2004, 2005, 2006, 2007, 2009, 2010, 2011 and 2012]. If true and consistent, Dr. Fiore, why effectively outlaw counseling unless accompanied by pharmacology use when the newest real-world evidence on earth suggests that counseling alone is more effective than counseling accompanied by NRT?

  8. Dr. Fiore, I expect you to assert that the reason for allowing counseling, but only when used in conjunction with pharmacology, is that you have located clinical studies showing counseling more effective when used with pharmacology. The 2007 Guideline draft I reviewed and submitted 25 pages of comments to you regarding, comments I hope were shared with other panel members, suggested that someone had cherry-picked a few extremely weak counseling studies in an obvious attempt to justify outlawing counseling as a stand-alone quitting method. Why? Is it a proper function of government to be intellectually dishonest with smokers, to use policy to limit choices and destroy competition?

  9. What is your opinion of forums like WhyQuit? Since mid-2000 WhyQuit has been the Internet's leading non-pharmacology quitting forum, in motivating, educating and supporting cold turkey nicotine cessation. Do you understand that by writing U.S. cessation policy so as to require pharmaceutical quitting product "use by all patients attempting to quit smoking," that you not only instantly damage the credibility of such programs but create license to bash and trash America's most productive quitting method, and the confidence of those engaged in it?

  10. Is it your intent, Dr. Fiore, to deprive cold turkey quitters of knowledge of the existence of non-pharmacology programs that you know would enhance their odds of success? Do you know that WhyQuit is the Internet's #2 quitting forum but due to your June 2000 mandatory pharmacology use recommendation that between 2000 and 2008 no federal or state Internet health site provided any link to any cold turkey quitting program, including WhyQuit? Are you proud of that?

  11. A June 2004 blinding review by Mooney found that NRT studies were generally not blind as claimed. In that the Guideline relies almost exclusively upon clinical trial evidence flowing from placebo controlled studies, is it possible that the entire Guideline is grounded in sham science, that it may be impossible to blind nicotine addicts having any significant quitting history, as to arrival and onset of full-blown withdrawal? [also see 2008 Polito, CMAJ]

  12. Does the 2008 Guideline alert physicians as to the 2004 Mooney study and the fact that cessation pharmacology studies were generally not blind as claimed? If not, why?

  13. In Pfizer's recent Chantix studies, nearly 80% randomly assigned to receive placebo were smoking at two weeks, which is comparable to what was often seen in NRT trials. Is it possible, Dr. Fiore, that thousands randomly assigned to clinical study placebo groups dropped out in the first couple of weeks due to withdrawal recognition and frustration, not due to an inability to quit?

  14. Dr. Fiore, can you name any other pharmaceutical product study area where those randomly assigned to the placebo group are actually punished and made vastly worse than when they arrived by being thrown into full-blown chemical withdrawal? Is it really so hard to see that using placebo blinding in quit smoking studies has been a license to steal?

  15. The 2004 Mooney blinding study warned researchers that the validity of "clinical trial results could be questioned" if future studies fail to make proper blinding assessments. Dr. Fiore, do you agree that the integrity of cessation clinical trials should be questioned when researchers fail to assess whether or not the trial was blind? If so, when should researchers conduct blinding assessments, within two weeks, while memories as to assignment beliefs are still fresh and accurate, and by which time the vast majority assigned to the placebo group have relapsed, or at 6 months, or a year, as some researchers are now doing. Even then, some are only asking surviving study participants and not going back and assessing beliefs of those who relapsed early.

  16. Dr. Fiore, have you ever published any paper critical of NRT, Zyban or Chantix? Hypothetically, if you were to admit that an ever growing body of population level evidence indicates that approved quitting products are less effective than quitting without them, or, in light of the FDA recently linking Chantix to suicide, suggest that smokers would be wise to delay use of Chantix until its safety is better understood, would you expect GlaxoSmithKline and Pfizer to continue funding your research? They'd cut you off in a heart beat, wouldn't they? You've built your entire reputation on sham clinical trials that were not blind as claimed. Would you ever dare bite the hand that feeds you?

  17. Dr. Fiore, is it fair, accurate and honest for those advocating approved quitting product use to equate clinical trial placebo group quitters to real-world cold turkey quitters, quitters who quit cold turkey because they wanted to, not because they were forced and compelled to do so, quitters who expected to endure full-blown withdrawal, not quitters who sought medication to diminish it?

  18. The practical effect of mandating pharmacology use is to make any non-pharmacology quitting recommendation a violation of U.S. cessation policy. It means that all government health agencies, both state and federal, will be expected to continue to ignore and blacklist pharmacology's only real competition, non-pharmacology quitting. Dr. Fiore, whose interests are served by such a policy?

  19. A February 8, 2007 front-page Wall Street Journal (WSJ) article exposed your pharmaceutical industry financial ties and questioned the appropriateness of you objectively heading a panel charged with writing U.S. cessation policy. Dr. Fiore, why would you knowingly invite bias criticism of our nation's cessation policy?

  20. The WSJ article shed light on the fact that you were chairman of the June 2000 Guideline panel while sitting in a university chair from which you annually receive a grant from GlaxoSmithKline (which markets NRT products), that you direct a research center that has received millions from the pharmaceutical industry to study its quit smoking products, and that until 2005 you worked as a paid pharmaceutical industry quitting product consultant. What makes you feel it is ethical for someone with such clear and strong industry financial ties to chair a panel determining national cessation policy?

  21. Dr. Fiore, the "Panel Agreement and Financial Disclosure" form you filed with the U.S. DHHS, signed by you on September 5, 2006, and obtained under the Freedom of Information Act, advised at the top that it "applies to the past 5 years." The disclosure request states, "I certify that all my affilations with or financial involvement (e.g. employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, royalties) with any organization or entity with a financial interest in or financial conflict with guideline matter or materials are dislosed completely here:" You chose to attach a typed document which you entitled "Statement of Disclosure," also bearing your signature which asserts, "In keeping with recent JAMA recommendations, Dr. Fiore does not accept honorarium nor do consulting work for the pharmaceutical industry. In 1998, the University of Wisconsin (UW) appointed Dr. Fiore to a named Chair, made possible by an unrestricted gift to UW from GlaxoWellcome." Dr. Fiore, in the February 7, 2007 WSJ article you claim to have stopped accepting pharmacutical industry quit smoking product consulting fees and honorariums in 2005. In testimony on May 9, 2005 in U.S. v. Philip Morris you did not then mention that you had stopped accepting consulting fees, but instead testified on PDF page 14 that, "Over the past five years, my outside consulting work on an annual basis has ranged between about $10,000 and $30,000 or $40,000 per year." Dr. Fiore, the obvious question becomes, if quitting product companies where paying you in 2005, which is clearly within 5 years of 2006, then why did you refuse to "disclose completely" details when requested to do so by the U.S. Department of Health? Given the above, in your opinion, would it be fair and accurate to assert that you fudged and falsified your Guideline panel financial disclosure statement, a federal form submitted to the United States government?

  22. Dr. Fiore, would you consent to bringing transparency and sunshine to the Guideline update process by voluntarily releasing to the media copies of all e-mails and letters in any way associated with the the updating process, including but not limited to all communications with those having pharmaceutical interests, or in any way discussing disclosure or ethical concerns?

  23. On May 11, 2006 the FDA announced approval of Pfizer's Chantix for smoking cessation. Dr. Fiore, your university website indicates that update of the June 2000 Guideline commenced on July 1, 2006. Did Pfizer representatives communicate with you at any time prior to July 1, 2006 about updating the June 2000 Guideline so as to include Chantix? Were pharmaceutical financial interests a primary motivation for the July 1 decision to update the Guideline?

Dr. Fiore, in that you hold yourself out as one of our nation's leading smoking cessation "experts," oh how I wish you'd accept a challenge to demonstrate via cessation competition that your advocacy, findings and Guideline pharmacology recommendations are not a scientific sham upon smokers. I offer a 6 month head-to-head competition against "real" cold turkey quitters, not frustrated quitters assigned to placebo. We could randomize 200 smokers to your choice of pharmacology or to a 12-hour cold turkey education program spanning two weeks.

In recruiting participants, I would ask that you not bias participant expectations in advance by telling them that the study involved "medication," as was recently observed on your website. Also, informed consent should be conducted after randomization. All participants would undergo cotinine testing at six months to establish cessation, and any nicotine use would constitute relapse. If your Guideline is true, how could you possibly fail?

When the 2000 Guideline was released you promised that pharmacology would "double, triple, or quadruple" success rates. It hasn't happened and you know it. You've boasted for years that what you do is unbeatable. All I'm asking is that you show us. If false, and pharmacology fails to prevail over educated cold turkey quitting, which will in fact occur, then I would hope your integrity would motivate you to fully cooperate in advocating immediate revision of the Guideline so as to permit counseling and support to occur without purchase of pharmacology products.

Dr. Fiore, it's child's play to design studies that take advantage of the average drug addict's enslavement awareness. The challenge is in successfully arresting and quieting awareness.


Last updated Tuesday, May 7, 2008 at 10:18 EST

No Copyright - This Article is Public Domain

John R. Polito is solely responsible for the content of this article. Any factual error will be immediately corrected upon receipt of credible authority in support of the writer's contention. E-mail comments to john@whyquit.com

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Written May 5, 2008 and updated June 5, 2015 by John R. Polito