Volume 11, Number 3, November 2000

Physicians, Alternative Medicine and the Duty of Informed Consent

Timothy Caulfield, BSc, LLM
Research Director, Health Law Institute, University of Alberta

I. Introduction

The popularity of complementary and alternative medicines (CAMs) is truly astounding. It has been estimated that Canadians spend over $1 billion annual on CAM1. Not surprisingly, this health care trend has led to an increasing number of physicians integrating CAM into their conventional practice. For many physicians, the rise of CAM is closely linked to the perceived failures of conventional medicine2 and, as such, they view CAM as a means of giving their patients the "best of both worlds."3

While this mixed approach to the practice of medicine is undoubtedly attractive to many health care consumers, and may be viewed as an open-minded response to public interests, it is not without legal pitfalls. The conflict between the increasingly evidence-based ethos which pervades the provision of conventional therapy16 and the scientific uncertainty that surrounds many CAMs seems destined to create difficult legal dilemmas. Specifically, the dearth of available evidence for many CAMs may make it difficult for physicians to satisfy the relevant legal standards of care.

This paper is a brief exploration of one of those legal obligations, the physician's duty of informed consent.

It should be noted that for the purpose of this article, we need not delve into the debate regarding the nature of "evidence." While many conventional therapies remain unproven, there is a strong trend toward evidence based practice. As such, the legal standard of care related to conventional practice will become increasingly linked to empirical evidence. Though an argument can be made that other forms of evidence can support the use of CAMs (e.g., anecdotal stories and historical use), there is a lack of traditional scientific evidence for many popular CAMs. As we will see, it is this tension which creates the legal difficulties. For better or worse, the legal standards for physicians are set in the context of traditional scientific evidence. What does this mean for the physician who wishes to provide an unproven CAM therapy?

II. The Physician's Duty of Disclosure

Canadian law places onerous disclosure obligations on physicians. Indeed, since the seminal Supreme Court of Canada case of Reibl v. Hughes4, the jurisprudence relevant to the consent process has expanded greatly. More than ever before, physicians are legally and ethically obligated to disclose a broad range of information to patients about the nature and effect of proposed treatment. How does this well established law of informed consent apply to the provision of CAM treatments?

To begin with, physicians who are involved in the provision of CAM therapies must provide information to patients about known risks. Though there is a perception that many CAM therapies are relatively harmless5, there are, in fact, many identified risks and adverse side effects6. And given the liberal approach that the courts have taken in the assessment of materiality7, there are undoubtedly many risks associated with CAM therapies which could be considered worthy of disclosure. For example, in a survey of individuals using manipulation, acupuncture, homeopathy or herbal medicine, 23.8% of respondents reported one or more adverse side effects from CAM use8. Many CAM products have also been identified with specific risks. To name but a few examples, products containing yohimbe extracts, such as those taken for male impotence, have been shown to be able to induce hypertension and, when taken by patients with allergic dermatitis, have also been associated with bronchospasm9. It has been demonstrated that spinal manipulation can cause or contribute to vertebral artery damage and neurological complications including stroke10. Blue-green algae may contain a toxic substance (microcystin) that, in large doses, "cause acute liver failure in humans, brain damage and death."11 Royal jelly has been shown to exacerbate or even induce fatal anaphylaxis in asthmatics12. Chinese herbs have been shown to cause or worsen renal disease and have been associated with cancer. 13

As scientific research on CAM therapies progresses, knowledge about risks will undoubtedly increase. Until more is known, however, a conservative approach to the assessment and disclosure of risks seems appropriate. Moreover, when advising patients about the risks associated with the use of a CAM, physicians should be sensitive to possible misconceptions about CAMs that may increase the likelihood of an adverse event. For example, patients should be reminded that just because a products is marketed as "natural" does not necessarily mean it is safe. Many CAMs, such as herbal therapies, can interact with pharmaceuticals, and the lack of standardization in the preparation of many CAM products may result in poor quality control14.

A number of herbs, such as ginko, also have blood thinning qualities which could be problematic for people on heart disease medication and could cause increased bleeding during surgery15.

In addition to disclosing known risks, physicians should candidly discuss available information relevant to the efficacy of the proposed or requested CAM therapy. Physicians must disclose "the limits of relevant knowledge, and the areas in which it appears that more needs to be learned." Applying this legal obligation to CAM, Boozang has argued that: "The physician should share at some level of detail the lack of evidence to support the patient's expectations for the treatment."17

Given the current state of scientific knowledge surrounding many CAM treatments, this aspect of the disclosure obligation may create problems for physicians - particularly because the pressure to use a CAM may come from the patient. Physicians may feel uncomfortable telling a patient who is interested in a particular CAM treatment that it has no scientifically proven therapeutic value. For physicians who have decided to provide a CAM which lacks a body of supporting scientific data (such as homeopathy)18, disclosure of information on the lack of scientific efficacy may send patients an odd, mixed, message ("why is the doctor offering the treatment if there is no clear evidence that it works?"). Nevertheless, the efficacy of a treatment seems to be central to the informed consent process. Indeed, given that research has shown that perceived efficacy is an important reasons why some individuals use CAM19, this is information that clearly has a potential to impact treatment decisions and, as such, is something that a reasonable person in the patient's position would want to know.

The fact that there is little scientific research on many CAM therapies may also have a direct impact on the scope of the physician's disclosure obligations. Some commentators have suggested that physicians should consider all unproven CAM therapies as experimental treatments and thereby "deserving of a heightened informed consent standard."20 Characterizing a treatment as experimental has important legal ramifications. Canadian law demands that all risks, no matter how rare or remote, be disclosed to a patient contemplating a truly experimental treatment21. Furthermore, in this context, non-disclosure cannot be justified by therapeutic privilege or by a waiver of the right to information by a patient. Although there can be no certainty when a court will deem a treatment "experimental," the fact that a procedure has not been subject to "any real research" has led a court to characterized a treatment as "experimental."22 Minimally, it seems safe to conclude that the questionable efficacy of many of the CAM treatments reinforces the need for a thorough disclosure process23. Boozang has gone so far as to suggest that the experimental standards should apply where there is neither proof of efficacy "nor any scientific expectation of any health benefit."

III. Are CAMs Different?

Are there reasons why CAMs should be treated differently than conventional treatments in relation to disclosure obligations? That is, are there reasons why physicians should not be required to disclose available information on efficacy and risks? On the one hand, it could be argued that the low physical risks associated with many (but not all) of the unproven CAMs means that a comprehensive disclosure obligation is not justified. In addition, the benefits that a patient could receive, via the placebo effect, may outweigh the possible harms associated with not disclosing information about the lack of scientific evidence. Patients may also have religious or spiritual conviction related to CAM use that may be offended by a frank disclosure of efficacy.

While these are all important considerations that should be taken into account in the formulation of disclosure policy (e.g., it is essential that physicians be sensitive to a patient's values and spiritual convictions), they seem insufficient to allow the creation of a different disclosure standard for CAM. First, though it is true that many CAMs are relatively benign, there are risks which seem worthy of disclosure, as noted above. In addition, the disclosure of efficacy and risk information may assist patients in avoiding possible indirect harms. For example, a patient may incur significant financial costs purchasing a CAM (most are not covered by provincial health care schemes or private insurance) or forgo effective conventional treatment in the belief that a CAM is effective24.

More importantly, however, Canadian jurisprudence has generally rejected the paternalistic approach necessary to justify selective non-disclosure - particularly when the use of a treatment is elective26. While the idea of withholding information for the good of the patient survives in the text of Canadian informed consent case law (a principle called "therapeutic privilege"), it is a principle that has been overwhelmed by the dominance of autonomy and, as such, should only be applied in rare circumstances (e.g., situations of severe emotional distress)27. It will be difficult for a physician to argue that she opted not to disclose information on the lack of known efficacy purely for the purposes of, for example, inducing a placebo effect or for fear of upsetting the patient. This is particularly so given that unproven a CAM can only be viewed as an elective treatment28.

IV. Conclusion

In the end, for many of the available but unproven CAMs, a legally appropriate consent process has the potential to sound harsh29. In general, physicians must tell patients about the lack of evidence concerning efficacy, the fact that patients will need to pay for most CAMs, and that there may be unknown risks. While this information must be disclosed, the physician should seek to provide it in a manner that is respectful to the patient's beliefs and values. The goal should not be to dissuade the patient from using a CAM but to provide objective information that will allow a well informed decision about the use of CAMs. Despite the popularity of CAMs, any other approach to the process of informed consent in this context seems legally problematic.


References

  1. P. Wysong, "Hold Those Herbs" (8 August 2000) Globe and Mail R6.
  2. See O. Caspi, K. Koffler and L. Sechrest, "Letter: Use of Alternative Medicine by Women with Breast Cancer" (1999) 341 N. Eng. J. Med. 1155 at 1155: where it is suggested that the choice to use a CAM is "a marker of our failure as physicians to fulfill the obligation to 'cure sometimes, heal often, comfort always.'"
  3. See, for example, K. Foss, "The New Doctors Without Borders" (14 December 1999) The Globe and Mail R10.
  4. (1980), 114 D.L.R. (3d) 1 (S.C.C.).
  5. M. Seidl and D Stewart, "Alternative treatments for menopausal symptoms: qualitative study of women's experience" (1998) 44 Can Fam Physician 1271.
  6. D. Kessler, "Cancer and Herbs" (2000) 342 N. Eng. J. M.. 1742; and D. Atherton, "Towards the safer use of traditional remedies. Greater awareness of toxicity is needed" (1994) 308 BMJ 673.
  7. For examples of risks held to be material see Meyer Estate v. Rogers (1991), 78 D.L.R. (4th) 307 (Ont. Gen. Div.) (a 1 in 100,000 risk of a fatal reaction to a contrast media dye); Arndt v. Smith, [1997] 2 S.C.R. 539 (0.23% chance of a fetal anomaly); and, in particular, Leung v. Campbell (1995), 24 C.C.L.T. (2d) 63 (Ont. Gen. Div.) (1 in 300,000 risk of suffering paralysis as a result of spinal manipulation by a chiropractor).
  8. See generally, N. Abbot, A. White, and E. Ernst, "Complementary medicine" (1996) 381 Nature 361; and H. Yamashita, H. Tsukayama, Y. Tanno, and K. Nishijo, "Adverse events related to acupuncture [letter]" (1998) 280 JAMA 1563..
  9. P. De Smet, O. Smeets, "Potential risk of health food products containing yohimbe extracts" (1994) 309 BMJ 958.
  10. See, for example, F.C. Powell, W.C. Hanigan, & W.C. Olivero, " A risk/benefit analysis of spinal manipulation therapy for relief of lumbar or cervical pain" (1993) 33 Neurosurgery 73-79; K.P. Lee, W.G. Carlini, G.F. McCormick, & G.W. Albers, "Neurologic Complications Following Chiropractic Manipulation: A Survey of California Neurologists" (1995) 45 Neurology 1213-15. See also, P. Waldie, "Patient Awarded $20,000 After Suing BC Reflexologist" (22 October 1999) National Post (http//:www.nationalpost.com/news.asp).
  11. "Praise is Very Faint for Blue Green Algae" [reprinted with permission from The University of California at Berkeley Wellness Letter] (23 November 1999) Globe and Mail R9.
  12. F. Thien, et al., "Royal jelly-induced asthma" (1993) Med J Aust 639; R. Bullock, et al., "Fatal royal jelly-induced asthma [letter]" (1994) 160 Med J Aust 44.
  13. D. Kessler, "Cancer and Herbs" (2000) 342 N. Eng. J. M.. 1742; A. Abt, et al., "Chinese herbal medicine induced acute renal failure" (1995) 155 Arch Intern Med 211; and D.Gordon, et al., "Chaparral ingestion. The broadening spectrum of liver injury caused by herbal medications" (1995) 273 JAMA 489.
  14. See, for example, M. Cirigliano and A. Sun, "Advising Patients About Herbal Therapies [Letter]" (1998) 280 JAMA 1565.
  15. P. Wysong, "Hold Those Herbs" (8 August 2000) Globe and Mail R6.
  16. In fact, B. Dickens, "Informed Consent" in J. Downie and T. Caulfield, eds., Canadian Health Law and Policy (Toronto: Butterworths, 1999) at 129. See also J. Maclean, "Alternative Medicine: Special Committee to Examine 'Alternatives'" (College of Physicians and Surgeons) (May 1, 1996) http://www.cpso.on.ca/articles.asp?ArticleId=133620864 , accessed December 8, 1999), where a recent position of the British Columbia College in relation to "unproven and unconventional treatments" is reported thus:

    All physicians must use recognized generally accepted methods to establish diagnosis. Unconventional or unproven methods of diagnosis can only be used as an adjunct to generally accepted methods. The patient must be informed of the unproven nature of such a diagnostic method.

  17. K. M. Boozang, "Western medicine opens the door to alternative medicine" (1998) 24 American J Law Med 185 at 212.
  18. J. Vandenbroucke, "Commentary, homeopathy trials: going nowhere" (1997) 350 Lancet 824.
  19. J. Astin, "Why patients use alternative medicine" (1998) 279 JAMA 1548 at 1552 where it is concluded: "The responses [to our survey of 1035 US citizens] suggest that the most influential or salient factor in people's decision to use alternative health care may be its perceived efficacy."
  20. Boozang, supra at 212.
  21. See Halushka v. University of Saskatchewan (1965), 52 W.W.R. 608 (Sask. C.A.); Weiss v. Solomon (1989), 48 C.C.L.T. 280 (Que. S.C.); and Zimmer v. Ringrose, [1981] 4 W.W.R. 75 (Alta. C.A.). See also, K. Glass, "Research Involving Humans" in J. Downie and T. Caulfield, eds., Canadian Health Law and Policy (Toronto: Butterworths, 1999) at 387-88.
  22. Archibald v. Kuntz, [1994] B.C.J. No. 199 (S.C.) (QL).
  23. Boozang, supra at 201
  24. See, for example, also Charell v. Gonzalez, 660 N.Y.S. 2d 665 (Sup Ct., 1997).
  25. See, Videto v. Kennedy (1981), 125 D.L.R. (3d) 127 (Ont. C.A.) at 136 where it was held that elective surgery is not a situation where a physician would be justified in withholding or generalizing information due to the "patient's emotional condition or apprehension."
  26. In Reibl v. Hughes, supra, Laskin noted: "[I]t may be the case that a particular patient may, because of emotional factors, be unable to cope with facts relevant to recommended surgery or treatment and the doctor may, in such a case, be justified in withholding or generalizing information as to which he would otherwise be required to be more specific."
  27. See, for example, Meyer Estate v. Rogers (1991), 78 D.L.R. (4th) 307 (Ont. Gen. Div.).
  28. See, for example, LaFleur v. Cornelis (1979), 28 N.B.R. 569 at 576 (Q.B.) where the court noted that "when the treatment is elective a very high standard of disclosure is required."
  29. There is another issue worth discussing in the context of informed consent. A significant percentage of those who use CAMs also use conventional treatments. There is a potential that some CAM treatments may interact with or adversely affect conventional treatments. As such, it would be prudent for physicians to explore a patient's CAM use as part of the informed consent process - particularly given the fact that 70% of those who use CAM treatments do not tell their physician (55). D. Eisenberg, "The Invisible Mainstream" (1996) Harvard Med. Alum Bull. 20.