By Norman E. Kjono, September 10, 2006
"The Treating Tobacco Use and Dependence (revised 2000) CPG, sponsored by the US Public Health Service ... can be used as an example to focus on important considerations about the appropriateness of CPGs in the judicial system. Furthermore, the failure of many doctors and hospitals to deal with tobacco use and dependence raises the question of whether this failure could be considered malpractice . . ."
A recent research paper published in the journal Tobacco Control raises serious questions about expanding the basis for physician malpractice to include failure to provide smoking cessation services and products. The proposals in this research paper can have far-reaching cost and liability implications for practicing physicians. It is important to review the published proposals in light of increased medical care costs, product efficacy, and health consumer acceptance of current smoking cessation programs.
A Brief Background
Earlier this year I engaged in debate with University of California at San Francisco's Stanton Glantz concerning Environmental Tobacco Smoke (ETS) on Voice of America (listen to the VOA debate). When confronted with the inaccuracy of and omissions from his widely-touted claims about secondhand smoke Mr. Glantz' response was to exclaim "that's ridiculous," then proceed to drone on ad infinitum. Hence, the title of this work. As will be illustrated below, to me such is the only possible response to Mr. Glantz' proposals in the research paper excerpted above.
Then again, contradiction is nothing new to those who follow Mr. Glantz' proclamations. Some contradictions date back nearly a decade. See, for example, "Some Thoughts for Mainstream Media," published by Forces.org in January 1998.
In a December 26, 1997 E-Mail to tobacco control advocate Mike Pertschuck Mr. Glantz wrote:
"For a summary of why the failure to reduce adult smoking was totally predictable, see my editorial, 'The youth access trap' (Am J. Pub. Health, 1996;86:156-158)".
On January 18, 1998, in a article published by the Congressional Quarterly, while lamenting the demise of funding for the George H.W. Bush administration's $135 million 1991-1998 Project ASSIST, Mr. Glantz opined:
"It is troubling that the one thing that works to get people to stop smoking is in danger of being dismantled and the victim of politics".
Underlines in the two preceding quotes are added by me. What an amazing difference a scant two weeks makes! Depending on the agenda to be advanced, programs that cost taxpayers hundreds of millions can progress from documented failure to unqualified success. Physicians, please place tongue firmly in cheek - this is the "quality" of opinion that now supports filing malpractice suits against you. Whatever works for the agenda-of-the-moment, regardless of how today's claims conflict with the evidence or previous or yesterday's spin, is the apparent standard by which your professional liability and your malpractice insurance premiums could be determined.
In light of that background we proceed to a current promotion by Mr. Glantz that raises troubling concerns for physicians, plus all consumers and taxpayers (including those who do not lawfully choose to use legal tobacco products.)
From the abstract of an article co-authored by Mr. Glantz and recently published in the journal Tobacco Control (2006;15:447-45), "The US Public Health Service 'treating tobacco use and dependence clinical practice guidelines, as a legal standard of care:'"
"There are four items that need to be considered in negligence torts: legal duty, a breach of that duty, causal relationship between breach and injury, and damages. . . . Although each case of medical malpractice depends on a multitude of factors unique to individual cases, a court could have sufficient basis to find that the failure to adequately treat the main cause of preventable disease and death in the US qualifies as a violation of the legal duty that doctors and hospitals owe to patients habituated to tobacco use and dependence." (Underline added.)
It appears that physicians are now to be sued for malpractice if they fail to prescribe Nicotine Replacement Therapy (NRT) or other smoking cessation products for persons who smoke, in order to "adequately treat" their condition.
A peer response to this research paper was provided by Dr. Michael Siegel. See "Legal Reasoning in Malpractice Article is Not Sound." Dr. Siegel provides important contra views about causality. However it bears noting that the Agency for Health Care Policy and Research's (AHCPR) Clinical Practice Guidelines (CPG) extend beyond merely advising patients to quit smoking. Dr. Siegel does not address smoking cessation products in his response. Recommending smoking cessation products is also an integral part of adequate treatment under AHCPR guidelines. Those recommendations date back to at least 1996, as shown in the February 1998 testimony of Dr. John M. Eisenberg before the Senate Labor and Human Resources Committee. Item 4. under "What Works In Smoking Cessation" of his testimony states:
"Every patient who tries to quit should be offered effective treatments including social support, simple advice on how to quit successfully; and pharmacotherapies that have been demonstrated to increase the likelihood that a smoker will quit successfully - nicotine replacement therapies -- like the patch and the gum -- and the new non-nicotine medicine, Zyban."
The above recommendations concerning smoking cessation products in AHCPR guidelines carry through to today. In view of such facts we are confronted with a broader and more complex malpractice liability equation that extends well beyond merely advising patients to quit. We enter the shadowy realm of smoking cessation products. As will be shown below, such products may present a greater malpractice liability for doctors than the advice they provide for patients. The prospective liability is found in contradictions about smoking cessation products.
The first contradiction in Mr. Glantz' thinking is found in the research paper's conclusion. The conclusion states that each case of medical malpractice depends on many unique factors, yet it effectively mandates the same solution of prescribing smoking cessation products for all patients. By definition, if smoking cessation products are to be prescribed for all patients who use tobacco products, regardless of medical symptoms, the medication must have a future beneficial effect to prevent disease and/or death. Were that not so the medication would be prescribed for corpses. The medical condition addressed by Mr. Glantz' conclusion is not diagnosis of an illness. The medical condition is the classification of a patient as a tobacco user. Given that patient classification physicians apparently would be required to "adequately treat the main cause of preventable disease and death in the US." Failure to "adequately treat" the classification - regardless of, indeed even in the absence of, directly related medical symptoms - could result in a malpractice suit based on alleged "violation of the legal duty that doctors and hospitals owe to patients habituated to tobacco use and dependence."
The idea being that Mr. Glantz believes an alleged cause of future illness or death from smoking is so certain and compelling that doctors have an affirmative duty to "adequately treat" the condition immediately regardless of medical symptoms. This is akin to saying that a patient who is classified as an alcohol consumer must be placed in an alcohol abuse program to prevent prospective cirrhosis of the liver. Physicians who fail to do so could also face malpractice suits in the future under this wildly irresponsible theory of medical liability.
AHCPR guidelines recommend that doctors determine the tobacco use status of patients on each visit. See, for example, the statement of Dr. Eisenberg in the above-referenced February 1998 testimony:
"One simple, essentially no-cost intervention - expanding the vital signs to include smoking status -- markedly enhances the rate at which physicians then go on to help their patients quit;"
Mr. Glantz promotes the idea that once smoking status has been determined the prescribed course of treatment is mandatory. Consider the hypothetical case of a twenty-five year old patient in an emergency room to receive treatment for an ankle injury received during a Saturday morning soccer game. AHCPR guidelines include the physician taking the time to determine the patient's smoking status, then prescribing the appropriate treatments for that classification. Will the emergency room doctor face malpractice liability because they did not treat a broken ankle and tobacco use? Will the patient be forced to involuntarily pay for smoking cessation treatment to receive medical assistance for an injured ankle? By what standard must patients endure grilling about unrelated consumer choices in order to receive medical care? And how long until that hapless physician is sued by the injured soccer player for alleged failure to properly treat a broken ankle because the patient appropriately refused to put up with questions about smoking and was consequently declined medical care on that basis?
Today's technology and its impact on patient records also raise troubling questions. How many emergency room or routine care visits since 1996 do not have the tobacco use status vital signs information included? This is a gold mine for opportunistic trial lawyers: why not just data mine current medical records for specific health care providers, determine which doctors have not followed AHCPR guidelines to determine smoking status, then file a class action that alleges breach of duty based on "violation of the legal duty that doctors and hospitals owe to patients habituated to tobacco use and dependence"? Doctors will soon find themselves up to their eyeballs in frivolous lawsuits alleging violation of a duty that does not exist to treat a condition for which symptoms were not observed nor illness diagnosed. The prospect of such potential liability could drive up malpractice premiums for every doctor regardless of what individual doctors and medical care providers may actually be sued. Consumers and taxpayers would then necessarily pay higher costs for medical care.
Additional contradictions in Mr. Glantz' irresponsible research proposals are found in several areas:
1. Costs: The cost medical visit for prescriptions and the cost of smoking cessation products and programs is often cited as a barrier to use.
a.) Mr. Glantz' solution is apparently to drive up the cost of medical services for everyone through increased malpractice insurance premiums and additional time required for physicians to fill in the boxes. Mr. Glantz' mandates then pile on more costs with mandatory treatment to allegedly prevent non-diagnosed possible future illness allegedly related to tobacco use.
b.) Consider the conclusions about costs and other factors in a recent study, Annual Review of Public HealthVol. 26: 583-599 (Volume publication date April 2005) "Impact of Nicotine Replacement Therapy on Smoking Behavior" by K. Michael Cummings and Andrew Hyland:
"This review summarizes evidence pertaining to the role of nicotine medications in smoking cessation and focuses particularly on evaluating evidence of the impact that nicotine replacement therapies (NRT) have had on altering population trends in smoking behavior. . . . available forms of NRT (e.g., gum, transdermal patch, nasal spray, inhaler, and lozenge) increase quit rates compared with placebos by 50%-100%. . . . fewer than one in five smokers making a quit attempt do so with the benefit of NRT. Because not enough smokers are using NRT, the availability of NRT has not had a measurable impact on influencing population trends in smoking behavior. Among the factors contributing to the low utilization of nicotine medications are the inadequacies of the current dosage strengths and formulations of existing medications, smokers' perceptions of the high cost of the drugs, and concerns that many smokers have about safety and efficacy of nicotine medications. (Underlines added.)
c.) Now add recent research conclusions based on actual purchases for a box of Nicotine Replacement Therapy products and a carton of cigarettes on the same day at the same retail store (see Parity Pricing.) In the State of Washington the price for a box of Nicorette gum increased by $12.06 June of 2000 to January of 2006 for a corresponding increase of $12.00 per carton in new cigarette taxes. As tobacco control advocacy groups successfully promote increases in cigarette taxes to drive up the cost of tobacco products Nicotine Replacement Therapy Distributors increase the cost of their products by like amount. Since NRT products are currently exempt from state tobacco excise taxes this phenomenon becomes a direct transfer of state tax revenues - often used to provide emergency room and other medical care for patients - from state treasuries to pharmaceutical special-interest bottom lines. California voters were intelligent enough to avoid such self-serving public policy when they refused to pass a $2.60 per pack new tax on cigarettes through Proposition 86 in November 2006. But the residual effect of nearly a dollar per pack average increase in nationwide cigarette taxes since 2002 remains (see the Campaign for Tobacco-Free Kids, July 19, 2006, "Higher Cigarette Taxes"). The net effect is that Nicotine Replacement Therapy costs have been artificially inflated by a similar amount.
Considering medical provider and treatment costs alone, the Glantz proposals are fiscally dangerous. Physicians would face prospective malpractice liability, confront increased medical malpractice premiums, and consume valuable diagnosis and treatment time with patients to mandatorily prescribe smoking cessation treatments for some patients, most of who would not have related medical conditions diagnosed in the first place.
2. Efficacy: Nicotine Replacement Therapy smoking cessation products are well-documented to have about a 7 percent efficacy rate, which is to say a 1 in 15 chance that they will work for intended purposes as prescribed. There is an equal probability (6.7 percent) that consumers who use Nicotine Replacement Therapy delivery devices will become chronic, long term users. See for example, two studies:
a.) From the journal Tobacco Control 2003;12:21-27 "A meta-analysis of the efficacy of over-the-counter nicotine replacement" J R Hughes, S Shiffman, P Callas and J Zhang Received 20 March 2002 Accepted 4 December 2002"
"The long term (that is, greater than six months) quit rates for OTC NRT was 1% and 6% in two studies and 8-11% in five other studies. These results were not homogenous; however, when combined the estimated OR was 7%." (Underline added.)
b.) From the journal Tobacco Control 2003;12:310-316 "Persistent use of nicotine replacement therapy: an analysis of actual purchase patterns in a population based sample" S Shiffman, J R Hughes, J L Pillitteri and S L Burton Received 10 October 2002 Accepted 7 May 2003:
"That is, among those who start using nicotine gum, 6.7% are likely to still be using it after six months. Among those who engaged in persistent use in this sample, the duration of such use averages 8.6 months (that is, once users cross the six month threshold, they use for another 8.6 months, on average). Using the formula specified in Kleinbaum et al38 . . . we estimate that 36.6% of current gum users (in cross section) are engaged in persistent use." (Underline added.)
Adding competence insult to professional injury, the Glantz proposals would impose the threat of malpractice law suits for failure to recommend or prescribe Nicotine Replacement Therapy products that are a mere 7 percent effective (and therefore 93 percent ineffective) for intended use, and to which it is known more than one-third of the current consumer population can become addicted. So what will the doctor do to defend another malpractice suit when it becomes evident that nicotine patches can present the same risk of blood clots in otherwise healthy patients, as emerging science is beginning to demonstrate for birth control patches?
3. Consumer Acceptance: The apparent need for mandated coercion of physicians to recommend or prescribe therpay on pain of being sued is an admission of smoking cessation products' abysmal failure to achieve meaningful market share. If the products worked for intended use and tobacco control's claim that 70 percent of smokers want to quit were true consumers would be clearing them off the shelves in something akin to a morning-after-Thanksgiving shopping rush. The response of tobacco control advocates such as Mr. Glantz is - now predictably - to mandate physician prescription or recommendation of the products. Such mandates are driven by an Anti-Mentality approach to important health subjects by the Agenda-Afflicted. Consider the approach of the Seattle-King County Department of Public Health to smoking and the use of smoking cessation products, to illustrate this point:
a.) From Seattle Weekly, January 18, 2006 "Big Nanny Is Watching You," by Philip Dowdy Quoting Roger Valdez, Director of Tobacco Prevention, Concerning I-901 Seattle-King County Department of Public Health:
"Americans think they have a lot of rights they really don't have. Smoking is one of those things where people think they have a right to smoke, but you don't. . . . You have no right to smoke. It's an addiction. It's something you should see a doctor about. . . . The condo association can ban it, and you have no legal recourse."
b.) From Seattle Weekly, February 1, 2006 Roger Valdez Letter to the Editor, "Try the Patch" (scroll down to the letter on this page):
"We have compassion for smokers battling a powerful addiction . . . Affordable treatment is key: We offer a free nicotine patch program, and we are advocating for important changes in the law to mandate smoking cessation treatment on demand for those with health insurance and offer support for those with no coverage."
Based on the Glantz proposals it would appear that tobacco control's version of rights that Americans do not have is a physician's right to protect oneself from spurious malpractice lawsuits for failure to prescribe and/or recommend smoking cessation products that are minimally efficacious for intended use, are artificially inflated in price, are rejected by most patient consumers, and impose new costs of health providers.
A Pattern of Conduct
The November 2006 Glantz malpractice proposals carry forward a now-predictable approach by tobacco control, the use of threats of lawsuits to impose their mercantile strategy on others, most often carried out by aggressive litigator John F. Nanzhaf III, Esq. By predictable I mean an observed and repetitive pattern of conduct. Mr. Glantz stands as a somewhat dimmer bulb than Banzhaf among the litigation luminaries of tobacco control. Mr. Banzhaf, a Professor of Law at George Washington University is noted for his 1996 promotion of a book that included a tested and proven plan to cyanide product tamper with cigarette packages for the express purpose killing persons who smoke (see October 1997 FBI Criminal Complaint at Forces.org.) Mr. Bazhaf threatened to sue me if I proceeded with my complaint. I did, he didn't. During the 1980s Mr. Banzhaf also coerced airlines to ban smoking with threats of lawsuits.
More recently, in 2003 Banzhaf threatened to sue the Seattle School District, including suits against district board members, if they voted to renew a vending contract with Coca Cola (see "Suit Over Suet," published by Forces.org). Those litigation threats included alleging the failure of the school board to fulfill its duty to protect the health of children, a theme remarkably similar to that propounded by Glantz about physicians and hospitals failing to fulfill their alleged duty to smokers.
At present, it appears Mr. Glantz is touting his own copy-cat, wannabe version of litigation threats to coerce physicians, too. Which should be no surprise to those who have followed tobacco control over the years, Banzhaf and Glantz have been fellow-warriors in the anti-tobacco trenches for decades.
We observe the tobacco control net created to trap persons who smoke now ensnaring physicians in its not-so-tender grasp. The fatally flawed tobacco control approach to smoking cessation continues regardless of its merit or the absence of positive results to date. It agenda is fixated as to its intent to promote the sale of pharmaceutical products, constant as to its institutional entrenchment, and ever-expanding as to those it adversely effects.
To illustrate the fixation of tobacco control on promoting the sale of pharmaceutical products, consider the timing of Glantz' research paper. It is published coincident in time with the aggressive promotion of Pfizer's new anti-smoking pill. From MSNBC News, November 28, 2006, "Smokers, It's Not Enough To Just Cut Back," by Reuters:
"LONDON - Smokers eager to cut the risk of dying early from tobacco-related illnesses must quit completely, researchers said on Tuesday, because cutting down - even by half - is not enough. 'Smokers should quit - you can't give your health a better present than to quit smoking,' said Dr Kjell Bjartveit, former director of the National Health Screening Service, in Oslo."
Those who read that article will find a complete overview of smoking cessation product's from Pfizer's recently-announced Chantix blocker, through prescription products like GlaxoSmithKline's Zyban, and on to Nicotine Replacement Therapy patches such as NicoDerm CQ manufactured by Johnson & Johnson subsidiary ALZA Corp. and others. The entire article is an infomercial about smoking cessation products, precisely delivered as to timing in the context of Glantz' threats to sue the socks off physicians who do not prescribe courses of treatment that include products that the infomercial recommends.
Welcome, physicians, to the Brave New World of infomercial mandates backed up by threats of spurious lawsuits to enforce compliance. Perhaps Mr. Valdez in Seattle is correct: "Americans think they have a lot of rights they really don't have." Mr. Glantz' proposals make it clear to me that the absence of assumed rights applies equally to doctors as it does to persons who smoke.
The only possible response to Mr. Glantz' irresponsible malpractice proposal is his own words: "That's ridiculous!"
Norman E. Kjono