Wednesday, November 29, 2006

Tobacco Control Research and Education Center Suggests Malpractice Lawsuits as a Way to Get Physicians to Prescribe Pharmaceuticals to Smokers

In an article in this month's issue of Tobacco Control, two tobacco control researchers from the University of California, San Francisco's Center for Tobacco Control Research and Education suggest malpractice lawsuits against physicians as an appropriate approach to get doctors to follow smoking cessation guidelines put out by the U.S. Public Health Service. Those guidelines call for pharmaceutical treatment of all smokers who are willing to quit, except in cases where there are medical contraindications to pharmaceutical use. Patients who state that they are not interested in quitting must be given a motivational intervention.

(See: Torrijos RM, Glantz SA. The US Public Health Service "treating tobacco use and dependence clinical practice guidelines" as a legal standard of care. Tobacco Control 2006;15:447-451).

According to the article: "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. ... The PHS Treating Tobacco Use and Dependence CPG forms a strong basis for a legal duty, whether it is used as a tool to support expert witness testimony in traditional litigation or as a judicially noticed presumptive standard of care under a litigation reform model. Given the PHS guideline'’s straightforward recommendations, the broad agreement regarding the efficacy of its treatments, its cost effectiveness and the recognised ability of smoking cessation to prevent serious disease, a doctor or hospital might be hard pressed to defend against a failure to properly treat tobacco use dependence."

The guidelines that are suggested to represent a legal standard of care call for the use of pharmaceuticals on all patients who are willing to try quitting smoking: "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."

For patients unwilling to try quitting or simply uninterested in quitting, the guidelines require physicians to implement a motivational intervention to try to persuade the patient to quit smoking. The motivational intervention must be repeated every time the patient visits the clinic, regardless of whether they indicate a desire to quit smoking at that time.

For patients who have quit smoking, even if years earlier, the guidelines require physicians to engage in relapse prevention interventions even if the patients "no longer consider themselves actively engaged in the quitting process."

The Rest of the Story

The first part of the rest of the story is that the chair of the panel which developed the guideline is a pharmaceutical collaborator, consultant, and grant recipient. Dr. Michael Fiore, the panel chair, collaborated with Glaxo Wellcome and received research funding from Glaxo at the time the CPG was released in 2000.

In addition, as of 2001, Dr. Fiore had "served as a consultant for, given lectures sponsored by, or ... conducted research sponsored by Ciba-Geigy, SmithKline Beecham, Lederle Laboratories, McNeil Consumer Products, Elan Pharmaceutical, Pharmacia, and Glaxo Wellcome."

In other words, the head of the panel that produced this clinical practice guideline had an extensive financial interest in the pharmaceutical industry and had in fact a financial relationship with most, if not all, of the pharmaceutical companies that manufacture drugs whose use is recommended in the guideline.

Moreover, 11 of the 18 panel members who developed the guideline acknowledged financial relationships with one or more pharmaceutical companies (see page 173 and 174 of the guideline). Three out of the five project consultants had financial relationships with Big Pharma. To make matters even worse, one of the peer reviewers of the report was the head of Psychiatry Clinical Development at Glaxo Wellcome (see page 159).

Thus, the guideline is anything but an independent review of the evidence and an objective assessment of the most effective approaches to smoking cessation in the population. It is a strategy that was put together largely by individuals with a vested financial interest in promoting pharmacotherapeutic treatment (and not cold-turkey treatment) of smoking cessation.

Essentially, what it comes down to is that this article is promoting a very specific form of treatment for smokers -- pharmaceutical treatment -- and suggesting using the force of malpractice lawsuits to coerce physicians into following this pharmaceutical-influenced and pharmaceutical-based guideline rather than any other of a multitude of approaches that could be taken to encourage and assist smoking cessation among one's patients.

Personally, I have found in my experience that pharmaceutical treatment for smoking cessation is ineffective. The most success I have had or seen is lifestyle change, with or without a spiritual element. In fact, I would go so far as to note that in my experience, the use of pharmaceuticals tends to obscure for the patient the most important and pressing issues they will have to deal with in sustaining cessation and becoming free of the addictive power of smoking. In the long run, I believe this makes it more difficult for patients to achieve a long-term success.

By the argument presented in this article, I should be charged with malpractice for adhering to an approach which I believe (and can document, for my own patients) worked far better than the use of drugs.

Before actually dealing with the issue of malpractice itself, I need to dispense with another troubling aspect of this article. One of the things that the article suggests (in addition to the prescription of pharmaceutical treatment for cessation under the threat of malpractice lawsuits) is the disrespect for the expressed desires of one's patient, even if those desires are expressed uniformly, definitively, and consistently. And again, this disrespect for patient autonomy is required at the threat of a massive lawsuit.

If a patient makes it clear to the physician that he or she is fully aware of the risks of smoking but has made an informed decision that he doesn't wish to quit, must the physician not respect that decision and continue to badger the patient with a prescribed motivational intervention at every visit? Even if the patient is definitive and consistent in her expressed desires and decision?

And is a malpractice lawsuit the appropriate strategy to deal with this issue, even if it were legally justified (and we'll get to that in a minute). Smoking is the only behavior for which I have ever heard it suggested that physicians should be charged with malpractice if they fail to put their patient through a specific prescribed set of interventions that include drugs and badgering the patient consistently even after a clear and consistent expression of a lack of desire to alter the behavior.

There are a fair number of my patients who liked to eat eggs for breakfast, and while cutting eggs out of the diet is a tried and true way to reduce cholesterol, I never heard it suggested that I should face a malpractice lawsuit if I didn't put my patient through a de-eggification intervention.

And if I did an intervention and the patient told me that they loved eggs and despite knowing the risks, wanted to continue eating them, it never would have occurred to anyone that I might face a malpractice lawsuit if I didn't repeatedly institute a motivational intervention at every patient visit, repeatedly going over the cholesterol-enhancing effects of fried eggs, Egg McMuffins, and eggs benedict.

This leads us to the practical problem of requiring physicians to intervene on a preventive basis for a host of individual behaviors in order to avoid a malpractice lawsuit. What if I fail to prescribe an exercise program for my overweight patient? Does that mean I'll have to face him in the courtroom if he has a heart attack due, in part, to persistent obesity that I failed to solve for him?

But most importantly, what kind of mishegas is this?

Is this really the way we want to practice tobacco control and public health? Do we really want to encourage hundreds of lawsuits against physicians and hospitals for what is intrinsically a personal behavior choice that these patients have made? Do we want to clog our courtrooms with these frivolous lawsuits and tie up the court system even further for no good reason? Do we want to start out down the slippery slope that could logically lead to malpractice suits against physicians for failing to solve a host of other health-related behavioral problems of their patients?

And we haven't even gotten to the legal foundations of the article yet.

The Legal Basis for Failure to Follow PHS Cessation Guidelines as Medical Malpractice

The article points out that there are four essential showings in a medical malpractice case: "As in all negligence torts, a plaintiff claiming medical malpractice must show: (1) a legal duty owed to the plaintiff by the defendant; (2) a breach of that duty; (3) a causal relationship between the breach of duty and the incurred injury; and (4) damages."

I find the argument provided in the paper to be non-compelling. The primary reason for this is that the paper 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 2 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.

This seems an unreasonable, if not impossible, point 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 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. Sure, one could successfully argue that there is a legal duty to the plaintiff to advise her to quit, that the physician breached that legal duty, and that there were damages incurred. But one could not hope to establish that the incurred injury was a direct result of the physician's failure to follow the guidelines, and thus that the damages stemmed from the negligent act. Even had the guidelines been followed, it is most likely the case that the patient would still have suffered the injury because more likely than not, they would have failed to quit smoking.

The situation is quite different in cases where there is a direct connection between the breach of duty and the incurred injury. If a physician fails to diagnose a person's heart disease because they fail to order an EKG or stress test when a patient presents with exertional chest pain, and the patient goes on to have a heart attack, it is reasonable to expect that one could show that the failure to diagnose the heart disease caused the injury - in other words, that the heart attack would not have occurred if the heart disease had been diagnosed and treated. But if a patient who smokes sees a doctor and a month later has a heart attack, it is not reasonable to expect that one could prove that the failure to advise the patient to quit smoking caused the heart attack - in other words, that the heart attack would not have occurred if the patient had been advised to quit smoking. The important point is that one must prove not that the heart attack would not have occurred if the patient had quit smoking (which is difficult enough), but that the heart attack would not have occurred if the patient had been advised to quit smoking.


Ultimately, what troubles me the most about this article is not the fact that it is devoid of any real legal substance or that it is inappropriate in a number of ways, but the fact that it is indicative of a larger problem in tobacco control: that we're headed in the wrong direction, spinning out of control, going off the deep end, losing our sense of reason, and becoming so narrow-minded that we are blind to everything other than smoking.

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