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Commentary: the law, unproven CAM and the two-hats fallacy

Posted 03 April 2012

"In the end, the law should act as a unifying force, nudging physicians towards a consistent and evidence-based approach to all therapies, be they CAM or conventional. The two-hats problem outlined above is fed by two growing and (seemingly) conflicting social trends: the continued public interest in CAM and the push towards evidence-based medicine. But when providing medical care, physicians can only wear one hat: that of an evidence-based practitioner."

A most interesting article on complementary medicine by Timothy Caulfield published in the journal,  Focus on Alternative and Complementary Therapies 

Commentary: the law, unproven CAM and the two-hats fallacy

Timothy Caulfield
Focus on Alternative and Complementary Therapies
Volume 17, Issue 1, pages 4–8, March 2012

Article first published online: 16 FEB 2012 DOI: 10.1111/j.2042-7166.2011.01135.x

http://onlinelibrary.wiley.com/doi/10.1111/j.2042-7166.2011.01135.x/full

A practice trend?

As in many countries, the interest in and use of CAM is increasing both among the general public and within

specific patient groups.1 While physician attitudes towards CAM vary considerably depending on such factors as the type of CAM being considered,2–4 research has consistently shown that many in the medical community have a generally favourable opinion towards CAM treatments, including the idea of providing CAM as part of clinical practice.5,6

It is no surprise then, that many physicians, particularly family physicians, are responding to the public interest by offering patients a wide range of CAM services. One study found that about 12% of Canadian family physicians offer CAM services directly to patients.7 In some Canadian provinces, the percentage is particularly high; for instance, in British Columbia, it is around 22%. It is not clear what, exactly, is being offered, but there are hints. In my home province of Alberta, physicians must apply to the College of Physicians and Surgeons of Alberta (CPSA) for permission to provide a CAM therapy.8 This has allowed the CPSA to compile a publicly available list that has both physician names and the broad category of the CAM that is provided. This list includes many CAM therapies that have unproven clinical value, such as homeopathy, chelation and reiki.


Legal dilemmas

Given the degree to which CAM treatments appear to be part of the practice landscape for Canadian medical doctors, a consideration of the potential legal issues associated with the provision of unproven CAM treatments seems warranted. This is a topic that has been tackled by others.9–11 But despite the existence of this useful commentary, there are several reasons why a revisiting of key challenges is timely.

A simple truth lies at the heart of most CAM liability issues: the law will not (or should not) allow a different legal standard to be applied to a physician in the context of CAM as compared to conventional therapies. Let us call it the ‘two-hats’ fallacy. A physician cannot switch hats from being evidence based to not being evidence based depending on the services he or she is offering a patient.12 Given that the push towards a more evidence-based approach to the provision of healthcare continues to intensify, any departures from science-informed patient care seems difficult to justify or sanction. More importantly, from the perspective of this commentary, it also makes the idea of a separate legal standard for CAM all the more irrational. In fact, provincial licensing bodies now state that there is an ethical obligation to practice in a science-informed manner. For example, the 2008 Practice Guide from the College of Physicians and Surgeons of Ontario states that ‘physicians should provide medical care based on objective evidence whenever possible’.13 The Guide also compels physicians to take a ‘scientific approach to solving clinical issues for the benefit of the patient’.13

A related trend (one that is a direct result of the public interest in CAM and the public funding of CAM-related research) is the accumulation of more good evidence on the effectiveness of many CAM therapies. This has led to a growing consensus within the scientific community about the limited therapeutic value of many of the most popular CAM treatments.14–16 This information is readily accessible to both the general public and to healthcare professionals; thus making the two-hats posture all the more indefensible.

But perhaps the most important reason to revisit the legal issues is that despite the growth and availability of evidence regarding CAM and the past cautions regarding concomitant legal issues, the number of healthcare providers involved in the provision of unproven CAM appears to be growing.

What follows is not a comprehensive analysis of all relevant legal issues. Rather, the goal is to use two examples – informed consent and standard of care – as a way of highlighting the incongruities and challenges associated with practitioners from a science-based profession (i.e. medicine) offering patients unproven CAM therapies. The analysis is done through the lens of Canadian law. Nevertheless, the principles and conclusions have relevance to most jurisdictions where this phenomenon occurs.


Informed consent

Healthcare providers have a legal and ethical obligation to disclose information to patients in order to facilitate informed decisions about treatment options. In Canada, the scope of the disclosure obligation is onerous,17 requiring, inter alia, information about risks, alternatives and the nature of the treatment.

Physicians must apply the same disclosure standard regardless of whether the treatment in question is conventional medicine or CAM. As a result, the informed consent obligation creates a particularly daunting two-hat dilemma for physicians who choose to provide CAM treatments to their patients – especially if the efficacy of the relevant treatment is questionable. For example, if a physician offers a patient a homeopathic treatment (and it appears that at least some Canadian physicians are doing this), there is a legal obligation to tell the patient that there is no evidence to suggest that the therapy works. In addition, physicians would need to provide patients with information about reasonable (and, if available, more efficacious) alternatives. And, of course, when there are known or possible risks, as is clearly the case for practices like spinal manipulation and chelation, these must be disclosed also.11

This legal reality creates an odd situation for physicians that recommend unproven CAM. Consider this: in many situations, a physician will be faced with the legal obligation to tell patients some version of the following: ‘This treatment does not work, may have risks, there are effective conventional alternatives and, since it is not covered by our health care system, you must pay.’

Arguments against this kind of frank approach include the concern that it would reduce the likelihood of deriving benefit from a placebo effect, and that it might undermine physician–patient relations and future communications about CAM use. Both arguments deserve comment.

While it is true that a legally appropriate informed consent process would likely undermine the potential to derive a placebo effect from the provision of a CAM therapy (though emerging evidence tells us that this will not always be the case),18 a for-the-good-of-the-patient deception strategy is legally and ethically untenable. If a physician has reason to believe that a treatment is ineffective – and, naturally, physicians should know what the existing evidence says about the treatment options they offer – the physician is required to disclose this information to patients even if the disclosure minimises the chance of a therapeutically beneficial placebo effect (this has been called the ‘lying dilemma’).19

Canadian courts, including the Supreme Court of Canada,20 have consistently found that therapeutic benefit is not a sound justification for the withholding of materially relevant information.21 To allow physicians to unilaterally decide when it is appropriate to disclose material information would undermine patient autonomy and foster a long-ago rejected paternalistic view of informed consent.22 Other than extreme circumstances (such as when there is the potential for severe emotional distress),20 physicians must tell their patients the truth. And in the context of many CAM procedures, such as homeopathy, reiki and chelation, this means telling them that there is little evidence to support the use of the treatment.

It is also true that candid discussions about efficacy may strain the channels of communication between physicians and CAM-enthusiastic patients. A confused and disheartened response seems particularly possible if the patient came to a physician looking for a healthcare professional supportive of CAM practices; which would be a fair assumption if the physician advertised that he or she offered CAM options. Many commentators have recommended that, in the context of CAM, physicians should adopt an open and non-judgemental communication style, thus facilitating free and unencumbered discussions about CAM.23–25 This approach makes sense. It has been found, for example, that if a patient who is interested in CAM perceives that a physician has a potentially judgemental attitude about efficacy, the patient is less likely to be forthcoming about his or her use or interest in CAM.26

Telling a patient that a recommended or requested therapy does not work could certainly create a confusing dynamic, one that could stifle future physician–patient discussions. But a frank discussion of efficacy – one that adheres to the norms of evidence-based medicine – does not necessarily have to be judgemental in tone. Indeed, as noted by one of the patients quoted in the Shelley et al26 study, the paramount consideration should always be honesty. To do otherwise may, in the long run, be more detrimental to physician–patient relations than a truthful disclosure about efficacy. It could lead to a loss of trust. ‘But whatever they do,’ the patient said, ‘they should be honest, and if they know something, they should be willing to share it’.26

It is also important to note that, as with the placebo dilemma, concern about an adverse patient response is not, from a legal perspective, a sound justification for non-disclosure.


Standard of care

Despite the communication paradoxes associated with the consent process outlined above, few commentators disagree that, from a legal and ethical perspective, an honest assessment and disclosure of the facts is required. This seems an accepted norm. A more contested issue is whether the provision of an unproven CAM is a breach of the standard of care and, therefore, a potentially negligent act.

There are some who feel that it is intrinsically unethical to offer patients a treatment like homeopathy. Smith, for example, has suggested (correctly, I think) that because homeopathy does not and cannot work, it is both harmful to patients and, as a wasteful legitimisation of a pseudoscientific remedy, to society more broadly.27 But is it always negligent?

Clearly, not all think so. Licensing bodies in Canada explicitly allow the provision of ineffective CAMs, including homeopathy.8 Many physicians have promoted a more open view of CAM approaches; a philosophy that is closely tied to the growing integrative medicine movement. And other commentators have actively encouraged the incorporation of CAM treatments into clinical practice.28

But what does the law actually say? Again, it seems likely that the law would have little tolerance for the two-hats thinking that is necessary to sustain the above CAM-tolerant positions.

Canadian physicians ‘have a duty to conduct their practice in accordance with the conduct of a prudent and diligent doctor in the same circumstances.’29 It is difficult to see how the provision of a treatment that has been established, via scientific investigation, to be ineffective can be viewed as satisfying the ‘prudent and diligent doctor’ standard.9 This is particularly so in the age of evidence-based medicine. Some scholars have gone so far as to suggest that there should be a legal duty to use an evidence-based approach to clinical care30 and that the legal standard of care should reflect not common practice, which lies at the core of the current standard-of-care test, but the best scientific information; thus creating an incentive for physicians to continue to learn and for practice to evolve.31

While there are certainly challenges and roadblocks to the integration of an evidence-based approach to the establishment of the legal standard of care (as noted by Foucar and Wick,32 the law ‘has traditionally not been very discerning about scientific rigor’), there is little doubt that a more science-based approach to clinical practice is now the dominant trend. As such, what a prudent and diligent doctor does, in the eyes of the law, will be increasingly based on scientific evidence. A two-hats ethos – that is, allowing physicians to jettison an evidence-based standard when utilising a CAM – is simply not compatible with this trend.

To be fair, Canadian law leaves latitude for physicians to depart from common practice in a manner that is not necessarily negligent. As noted by Bernard Dickens:

‘[t]he law recognizes that practitioners in a respected minority in their specialty can depart from generally approved professional guidelines, by retaining earlier practices that are not discredited, or by adopting newer, but non-mainstream practices.’33

But since unproven CAM treatments are, by definition, ‘discredited’ and are not, in general, a ‘newer’ form of practice (homeopathy, for instance, has been around for over 200 years), this defence is not a good fit for most CAM situations. Moreover, the facilitation of progress is one of the rationales behind the respected minority principle, a point noted by Justice Ellen Picard and Gerald Robertson who suggests it ‘encourages the adoption of new beneficial medical procedures’.34 An unproven and unscientific treatment would seem to fall short of this policy target.


Conclusion

Naturally, there are numerous other legal issues associated with physicians providing CAM. For example, the above conclusions are primarily focused on unproven therapies, such as homeopathy. But standard-of-care dilemmas can emerge whenever a CAM is provided, even when the therapy is supported by evidence.35 There is little standardisation in many areas of CAM36 and a great deal of variation in practice approaches and training.37 In such an environment, how is the standard of care to be determined? What should be viewed as common practice?

In addition, the consent issues are complicated by the fact that many physicians may be providing CAM as a way to supplement their income. Since CAM therapies are, in general, not covered by provincial health systems, physicians can charge patients extra. This situation creates an incentive to avoid a forthright discussion about the lack of evidence.11 Of course, a nondisclosure motivated by personal gain would be a clear breach of consent laws and a physician's fiduciary obligations.

In the end, the law should act as a unifying force, nudging physicians towards a consistent and evidence-based approach to all therapies, be they CAM or conventional. The two-hats problem outlined above is fed by two growing and (seemingly) conflicting social trends: the continued public interest in CAM and the push towards evidence-based medicine. But when providing medical care, physicians can only wear one hat: that of an evidence-based practitioner.
Acknowledgements

I would like to thank Amy Zarzeczny, Christen Rachul, Gerald Robertson, Erin Nelson, Katherine Fisher and Blake Murdoch for their assistance and insight.
Funding

I would like to gratefully acknowledge Canadian Institutes of Health Research (CIHR) for funding for the SafetyNET project. CIHR had no role in manuscript preparation.

Conflict of interest

None declared.

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Timothy Caulfield, LLM, FRSC, Canada Research Chair in Health Law and Policy, University of Alberta, Faculty of Law and School of Public Health, 4928-126 Street, Edmonton, Alberta, Canada, T6G 2H5.

E-mail: tcaulfld@law.ualberta.ca

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