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  1. Experience/performance may impose a duty to ignore pharmacology

    A legal duty to ignore cessation pharmacology

    After nearly two-fold efficacy over placebo in most clinical studies, NRT has proven no more effective than quitting without it in all real-world quitting surveys conducted since adoption of the June 2000 Clinical Practice Guideline (CPG): Minnesota 2002, California 2003, London 2003, Quebec 2004, Maryland 2005, UK NHS 2006, and Australia 2006.[1]

    In the most recent survey, among smoking patients of Australian family practice physicians, patients quitting cold turkey doubled the rates of nicotine patch, gum, inhaler and bupropion quitters and accounted for a whopping 88% of all success stories (1,942 of 2,207).[1]

    In fact, after more than two decades of use, NRT still cannot point to a single real-world performance victory in which those engaging in nicotine replacement prevailed over those engaging in nicotine cessation. The question we should all be asking ourselves is why?

    On 10/27/06 the CDC reported that for the first time since 1997 the U.S. smoking rate failed to decline. I submit that intimidating physicians into betraying two decades of practice observations may increase profits for those marketing replacement nicotine, bupropion and varenicline but not without substantial needless loss of life.

    Primary fault for our stalled U.S. rate is not with physicians. Whether nicotine or pain meds, it rests upon pharmacology dependent medical school curriculum developers who continue to ignore the core basics of chemical dependency recovery counseling. It also rests upon the very June 2000 Clinical Practice Guideline (CPG) here employed to coerce compliance by suggesting that physicians "might be hard pressed to defend" against civil malpractice liability if they fail to see CPG recommendations as imposing legal duties.

    The authors' objective is clearly admirable. Far too many physicians ignore ever advancing circulatory, pulmonary and mental health carnage fostered by years of chemical dependency upon smoking the highly addictive super-toxin nicotine. Imagine 81 IARC identified cigarette carcinogens (including polonium) slowly building time-bombs throughout the body, when the only action taken by the average physician is to tell the patient what, to them, is already obvious - "you need to quit."

    But in pounding the proverbial square peg into roundness the authors misstate the CPG's key objective, grossly overstate the document's credibility and, as already noted, confuse clinical efficacy with real-world effectiveness. As Professor Branzhaf notes, standards of care are born of consensus among impartial experts, rather than statements from hired guns. The CPG is anything but impartial. Although physicans have a duty to assist those dependent upon smoking nicotine they have no legal obligation to follow a pharmacology use directive that two decades of practical experience has convinced them is totally ineffective, a finding supported by all real-world evidence to date.

    The authors fail to note that CPG recommendation seven (R7) totally consumes the remaining recommendations. It reads, "Numerous effective pharmacotherapies for smoking cessation now exist. Except in the presence of contraindications, these should be used with all patients attempting tobacco cessation." Not with "some" patients but "all."

    PHS adoption of CPG R7 instantly discredited all non-pharmacotherapy counseling, support and behavioral cessation programs as being no longer in accord with U.S. cessation policy. Nicotine cessation programs that refused to integrate nicotine replacement found themselves in a state of policy illegitimacy with obvious financial and accreditation implications. Their choices were to stick with a true nicotine cessation format that within 3 days creates a nicotine free work space with the onset of full dopamine pathway neuronal re-sensitization (down-regulation), or amend the program to advocate use of chemicals which delay dopamine pathway re-sensitization for weeks or months.

    Since 2000 the CDC's primary quit smoking web page has evidenced total government abandonment of support for the cessation efforts of the 80 to 90% of U.S. smokers whose natural instincts are nicotine cessation, not replacement. PHS policy does not treat CPG R7 as optional. Smokers visiting the CDC website are told that key to quitting is to "get medication and use it correctly."[2] The page lists seven pharmacotherapies that include five different NRT delivery vehicles. It then clearly suggests that clinical study efficacy findings are being mirrored in real-world effectiveness in asserting that "all of these medications will double your chances of quitting and quitting for good." The CDC knows or should know that this assertion is false.

    Our government knows: (1) that nicotine is a psychoactive chemical producing an alert dopamine/adrenaline high with vasoconstriction, an increase in heart rate and blood pressure, heightened senses and an underlying "aaah" sensation; (2) that those with a quitting history are likely to have trained themselves to recognize their withdrawal syndrome; (3) that those seeking participation in pharmacology studies were not cold turkey quitters expecting to endure their withdrawal syndrome but instead those seeking "medications" that promised some degree of withdrawal syndrome reduction; (4) that a June 2004 review of NRT study blinding assessments concluded that NRT studies were generally not blind as claimed in that "subjects accurately judged treatment assignment at a rate significantly above chance";[3] and (5) that never once in any real-world quitting method survey to date has NRT use proven more effective than quitting without it.

    How many nicotine cessation programs survived R7? Very few. But if your patients type "quit smoking" into any major search engine they should encounter one or more such programs as government abandonment of abrupt nicotine cessation education, skills development, counseling and support has fostered demand.

    Ironically, a November 2003 persistent use study in this journal found that nearly 40% of nicotine gum users are chronic long-term users of greater than six months. Imagine R7 effectively banishing the very programs that could have aided those getting hooked on the cure. Under current policy where are they to turn to reclaim neurochemical control?

    The authors paint a picture of the CPG having been created by an independent panel of experts. The authoring panel had 17 members of which 11 openly acknowledge financial ties to the pharmaceutical industry in CPG Appendix C.[4] The panel chairman, who was also the director of the Center for Tobacco Research and Intervention (CTRI), discloses that he "has served as a consultant for, given lectures sponsored by, or has conducted research sponsored by Ciba-Geigy, SmithKline Beecham, Lederle Laboratories, McNeil, Elan Pharmaceutical, and Glaxo Wellcome." In 1996 he was openly labeling himself "a consultant to Glaxo Wellcome."[5] In 2005 he testified that the Robert Wood Johnson Foundation (RWJF) provided CTRI with more than $8 million in funding since 1998, that he had served as director of the RWJF National Program Office Addressing Tobacco in Managed Care since 1996, and that since 1998 he had sat in a $50,000 a year university chair funded by GlaxoSmithKline.[6]

    GlaxoSmithKline markets nicotine gum, a nicotine lozenge and nicotine patch. The RWJF clearly knows it could gain philanthropy credibility by severing financial and board member ties to Johnson & Johnson (J&J) and its product line, which includes a nicotine patch, nicotine inhaler and nicotine spray, but it hasn't. Instead it remains J&J's largest shareholder with a quarter of board members having been former J&J executives.

    RWJF claims that in August 1998 it contributed $102,016 to CTRI as its share toward updating the CPG. It notes that on September 14-15, 1999, panel members met in Madison, WI, where they evaluated findings and prepared a draft of the new Guideline. It also asserts that "the final version was submitted to RWJF and the USPHS for approval."[7] Also of note, RWJF paid at least $235,654 toward CPG dissemination.[8]

    The only fair conclusion is that pharmacology influence had major impact on the CPG. Stakeholders have no business managing the writing of U.S. cessation policy and the practice must stop. Imagine if the panel had included educators and counselors who had devoted their life to highly effective programs involving nicotine cessation, programs that RWJF and pharmaceutical companies would have zero interest in studying and promoting. Allowing more than one lone voice would likely have prevented R7 from consuming all other recommendations, and cost the pharmaceutical industry billions.

    I seriously doubt that many reviewing the CPG in 2000 grasped that the document was effectively outlawing pharmacology's only serious competitor, cold turkey. How many today grasp why pharmacology seems so wonderful inside clinical trials yet so dismal once outside clinic doors?

    How many smokers wanting to quit cold turkey would you expect to join a clinical trial offering a 50/50 chance of free medicine? For those seeking withdrawal syndrome diminishment, how many with a prior quitting history would be able to recognize full-blown withdrawal or, some degree of relief of withdrawal symptoms if assigned to the active group? How meaningful would clinical results be if frustrated or fulfilled expectations determined who survived and who relapsed? Real-world performace evaluations compel pharmacology quitters to at last go head-to-head with real cold turkey quitters. It's strange how the CDC relies upon surveys to establish every tobacco truth except the most effective quitting method.

    Is it fair to blame the CPG and specifically R7 for bringing a decline in the U.S. smoking rate to a halt? I believe it is. Let me briefly explain why. First, think about two decades and hundreds of millions spent bashing and trashing quitter confidence in the most productive method the world has ever known, cold turkey. Still, this year it will generate more than 80% of all long-term successful quitters.

    Those supporting R7 like to tell smokers that, "on average, it takes between three to five serious quit attempts before breaking free of tobacco dependence. Some may be successful on the first try, others may take three or more tries. I like to tell people to visit our clinic, that every time you make an effort, you're smarter and stronger, and you can use that information to increase the likelihood that your subsequent quit attempt is successful."[9]. What they fail to reveal is the precise lesson eventually learned or that the statistics they quote belong to nicotine cessation not nicotine replacement.

    Reflect on the amazing influence upon the mind of a quitter who smokes nicotine just once after quitting, in generating a new salient dopamine "aaah" prefrontal cortex "pay attention" memory. It's an "aaah" that their missing dopamine killjoy enzyme (suppressed by nicotine) allows them to savor far longer than normal. It isn't just that their mind tasted another stolen dopamine "aaah" sensation but that it will not allow them to forget. Just one powerful puff is the single greatest predictor of full and complete relapse back to their old level of nicotine intake or higher.

    We call it the "Law of Addiction."[10] This critical relapse lesson does not always come easy but eventually the failed quitter begins to see a bright line in the sand that says, "just one powerful puff of nicotine and I will again throw all this hard work out the window."

    It should be obvious that toying with the very chemical that the school of hard-quitting-knocks was eventually supposed to teach them to leave alone muddies the learning waters. Renaming nicotine "medicine," labeling its use "therapy" and two decades of telling quitters that they need to replace missing nicotine has clearly interfered with a natural learning process.

    Lastly, we know that unlike cold turkey quitting, where each new attempt actually increases the odds of success (unless the lesson becomes clouded by toying with pharmacology), with each subsequent NRT attempt the odds of success appears to decline. Shiffman's OTC NRT patch and gum meta analysis published here in TC in March 2003 found a 93% six-month relapse rate. But in the only two nicotine patch studies that have examined second time patch use rates, an average of 99% relapsed within six months. (100% Tonneson 1993, 98.4% Gourlay 1995). With second time NRT use rates climbing, this important yet little known finding should disturb all.

    I submit that physicians have a legal duty to believe their ears and eyes above clinical study assertions that will never ever be duplicated in real-world use. I too encourage physicians to read and rely upon all aspects of the CPG except for pharmacology performance efficacy claims and use recommendations.

    John R. Polito
    Nicotine Cessation Educator
    Editor WhyQuit.com

    [1] Polito JR, Cold turkey quitting twice as effective as NRT or Zyban, WhyQuit News, May 19, 2006
    [2] CDC, How and Why to Quit Smoking Today, last reviewed November 2, 2006
    [3] Polito JR, Widespread Blinding Failures Put Validity of Nicotine Replacement Studies in Serious Question, WhyQuit News, June 4, 2004
    [4]Appendix C: Financial Disclosures for Panel Members, Consultants, and Senior Project Staff, Clinical Practice Guideline, June 2000
    [5] Drug Abuse Advisory Meeting, December 12-13, 1006, see PDF page 14
    [6] United States' Written Direct Examination of Michael C. Fiore, M.D., M.P.H., Submitted Pursuant to Order #471, Department of Justice website, May 9, 2005, see PDF pages 14 and 15
    [7] Robert Wood Johnson Foundation, Quitting Smoking Long Term: Treatment Can Double the Likelihood, last updated July 2002
    [8] Robert Wood Johnson Foundation, Organizations of Health Professionals Distribute a Blueprint to Reduce Smoking, last updated June 2000.
    [9] Fiore MC, Quitting Tobacco: What Works and What Doesn't with Michael Fiore, WebMD, June 26, 2000
    [10] Spitzer J, The Law of Addiction, Joel's Library, last updated Aug. 23, 2003

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  2. Re: Legal Reasoning in Malpractice Article is Sound, and the Threat Should Be Taken Seriously

    As the public interest attorney and law professor who first developed the concept of using legal action as a weapon against the problem of smoking (e.g., getting antismoking messages on TV and radio, driving cigarette commercials off the air, starting the nonsmokers’ rights movement, etc.), I was delighted to read a paper suggesting the feasibility of using legal action to more effectively prod physicians to warn patients about smoking, and to assist them in quitting.

    Actually, by way of full disclosure, my organization [Action on Smoking and Health (ASH), http://ash.org] had made a similar suggestion in 2003, [http://ash.org/recommendations] and the New York City Health Department warned even earlier that, "because physician intervention can be so effective, failure to provide optimal counseling and treatment is failure to meet the standard of care – and could be considered malpractice." [City Warns Docs -- Help Patients Stop Smoking -- or Else, New York Post (12/13/02)].

    The Clinical Practice Guidelines referred to in the article greatly strengthen such law suits because courts and juries are often confused by – and therefore tend to throw up their hands regarding – testimony by competing physicians as to the standard of what other physicians do. Therefore they are increasingly likely to adopt, as a appropriate standard of care, some official document which represents a consensus among impartial experts, rather than statements from “hired gun” medical witnesses. This is even more true where, as in the case of the tobacco guidelines, they have been adopted and put into practice by prestigious medical organizations.

    Dr. Siegel makes some interesting observations but, as a physician rather than an attorney, he appears to be out of his field, and – with all due respect – perhaps out of his depth (despite his participation in some tobacco litigation), in bluntly stating that the “legal reasoning in [the] malpractice article is not sound.” As someone with almost 40 years of experience with anti-tobacco litigation – and who has been called the "Ralph Nader of the Tobacco Industry," an "Entrepreneur of Litigation, [and] a Trial Lawyer's Trial Lawyer,” "a Driving Force Behind the Lawsuits That Have Cost Tobacco Companies Billions of Dollars," and "The Law Professor Who Masterminded Litigation Against the Tobacco Industry," let me speak frankly in suggesting from a lawyer’s perspective why the legal reasoning is sound and why the legal threat is very real.

    While it is technically true that the plaintiff must prove – and then only by a “preponderance of evidence” and not “to a medical certainty” – that he would have quit if only the physician has warned him and assisting him in doing so, in practice this is not a major burden for several reasons.

    1. To survive the initial motion to dismiss – where the defendant asks the court to throw out the law suit so that defendant (and his insurance company) will not be put to the burden of defending it – the judge must assumes all allegations in the legal complaint are true unless they are clearly impossible on their face. Thus a judge would refuse to dismiss any law suit which alleged that the plaintiff would have quit if the physician had warned him to do so, even if such a proposition were clearly against the great weight of evidence. This refusal to grant the motion opens the door to pre-trial discovery – including depositions, demands for the physician’s time, documents, and records, etc. – places a blot on his record, and perhaps interferes with his ability to obtain malpractice coverage at favorable rates. That threat alone may motivate many physicians (and their medical organizations and insurance companies) to settle or – better yet – to follow the guidelines next time.

    2. In most jurisdictions, a judge will charge the jury that there is a legal presumption that the plaintiff would have heeded a warning, and this jury charge is usually given even regarding small-print routine warnings on tools, drugs, etc. which were merely inadequate rather than nonexistent. This presumption – which in effect shifts the burden on this issue onto the defendant – is likely to be far stronger where the specific face-to-face warning from a physician mandated by the guidelines was not even given, since judges as well as jurors know that warnings from authority figures in white coats are likely to be far more effective that tiny-print warnings on jars or packages. The presumption and jury charge, by the way, is generally given even if the defendant introduces strong empirical evidence that the plaintiff would not have heeded the warning.

    3. The question of whether the plaintiff would have heeded the advice and assistance of the physician if he or she had given it is a factual issue for the jury to decide, and the issue must be left to them if reasonably people could possibly differ – as they obviously can on this question. Experience clearly suggests that, faced with a sympathetic and very ill plaintiff who swears that he would have heeded a warning if it had been given, and a physician who (as his lawyer will argue) “thumbed his nose at his professional obligation, ignored the simple guidelines of a governmental commission and the unanimous advice of his peers,” the jury’s sympathy for the plaintiff will incline them to award him some damages, even if empirical evidence as well as common experience suggests how hard it often is to quit.

    4. The same is true with regard to the burden on the plaintiff to prove that, had he quit, he would not have had the medical problem of which he now complains. Sympathy may well be more important in a jury’s consideration of this issue than dry empirical and statistical evidence and related arguments put forth by “rich doctors and their greedy insurance company lawyers.” Moreover, since juries are so firmly convinced that smoking causes lung cancer, arguments about latency periods – and just when the first cell turned from healthy to pre-cancerous and then to cancerous – are not likely to be very persuasive. Plaintiff attorneys may also try to sue in situations based upon other diseases and medical problems triggered and/or exacerbated by smoking – e.g., heart attacks – where arguments based upon early damage and long latency periods will have less traction.

    5. Antismoking lawyers do not have to win every case, most cases, or even one out of every ten cases to put strong pressure on hospitals, medical organizations, insurance companies, and ultimately on individual physicians to begin complying with the guidelines to avoid the risk of being sued and the possibility – however large or small it may appear – of losing such a law suit. In this regard, many older physicians may remember an interesting parallel.

    6. Prior to 1975, it appeared that it was not the custom and practice of psychiatrists to issue warnings when their patients made threats in the presence of their doctor to do serious harm to spouses, friends, and other third parties. When the Supreme Court of California ruled in the Tarasoff case that such a failure to warn could give rise to legal liability if the patient carried out the threat, most psychiatrists reportedly changed their own policies quickly, without even waiting for the subsequent jury verdict which found the physician liable. There are, of course, many other instances where changes were quickly made in medical practice and procedure in response to law suits, and sometimes even to the threat of law suits. Indeed, it would be far better for those in the profession who do not currently follow these guidelines to begin doing so now, rather that waiting for one or more tests of this legal reasoning.

    7. Attorneys are likely to be eager to bring such cases since the damages are likely to be high, and they will involve far less research and preparation than traditional medical malpractice cases which often require a very careful review of the patient’s entire medical record to find examples of alleged errors, detailed medical research to be sure what the standard of care is, and the need to find qualified medical witnesses willing to testify that the named defendant violated the general standard of care required in this specific situation. It’s obviously much easier to find a plaintiff who had not been adequately advised and assisted to quit, and to find a witness who will testify that the guidelines do in fact represent an expert consensus as to the appropriate standard of care which are followed by prestigious institutions. Also, remember the old adage: “never underestimate the tenacity and creativity of an attorney on a contingency fee.”

    One final comment goes far beyond the narrow issue of liability for failing to assist patients to quit smoking. Dr. Siegel seems to suggest that any malpractice action based upon a physician’s failure to warn a patient of a potential risk, or to suggest a treatment (medication, operation, or other course of action), is doomed to failure if the proposed treatment is less than 50% effective: “Until such time as there is a truly effective treatment for smoking cessation (one that works most of the time), there really can be no basis for establishing a causal relationship between the breach of duty and the incurred injury.” In other words, by this reasoning, it would appear that the medical community would have no legally enforceable duty to do anything at all (including refraining from negligence) where the chance of success – much less the patient’s ultimate chance of survival – is less than 50%. But several courts have ruled directly to the contrary, finding that even plaintiffs whose conditions were so grave that their chance of survival was less than 50% still have a valid cause of action against a physician whose negligence decreases those already poor odds. Good physicians should never act negligently toward a patient, gambling that the dismal chance that a proposed treatment will be effective will shield them from liability.

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  3. Legal Reasoning in Malpractice Article is Not Sound

    I find the argument provided in the paper to be non-compelling because it fails to provide any reasonable argument for how the 3rd showing in a medical malpractice case - that there is a causal relationship between the breach of duty and the incurred injury - could possibly be met in a smoking malpractice case. This would require proving to the jury that the physician's failure to warn the patient to quit smoking was the cause of the injury sustained by the patient.

    This would imply that 3 things would have to be shown: (1) that the patient would have quit smoking if only the physician had advised them to quit and followed the PHS guidelines; and (2) that the reason the patient did not quit smoking was that the physician failed to advise them to quit and failed to follow the PHS guidelines; and (3) that if the patient had quit smoking, he would not have developed the injury.

    These seem to be unreasonable, if not impossible, points to prove. How can we possibly know that a patient would have successfully quit smoking if only the physician had followed the guidelines? Unfortunately, the overwhelming scientific evidence cited in the paper supports a conclusion that the patient would most likely not have quit smoking, even if the physician had followed the guidelines. The data demonstrate that the cessation success rate, even with physician treatment, is dismal. The success rate does not even come close to approaching 50%; thus, it is more likely than not that even with physician advice to quit smoking, the patient would not have been successful in quitting smoking.

    The success rates reported in the PHS guideline itself are generally below 20%. This means that it is much more likely than not (in fact 4 times out of 5) that a patient who goes through the suggested intervention will fail to quit smoking.

    I view this as an intractable problem in the use of the PHS CPG in medical malpractice lawsuits for failure to properly treat tobacco dependence. Until such time as there is a truly effective treatment for smoking cessation (one that works most of the time), there really can be no basis for establishing a causal relationship between the breach of duty and the incurred injury.

    Finally, it is important to note that one would not only have to show that the plaintiff would have quit smoking had only the physician advised them to quit; one would also have to show that had the person quit smoking, they would not have developed the injury. However, we know that many former smokers still develop smoking-related injuries. It is not clear that one could show that the plaintiff wouldn't have developed the disease even if they had successfully quit smoking, especially for a disease such as lung cancer where risk decreases slowly following smoking cessation.

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