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Western Medicine Opens the Door to Alternative Medicine

Published online by Cambridge University Press:  24 February 2021

Kathleen M. Boozang
Kathleen M. Boozang*
Affiliation:
Health Law & Policy Program, Seton Hall University School of Law; 1981, Boston College; 1983, Washington University; 1990, Yale University.
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Extract

Physicians have struggled to defeat alternative medicine, and to obtain a monopoly over the health care of their patients, since physicians began systematically organizing in the United States. They claim to oppose alternative medicine because it lacks efficacy, may waste precious health care dollars and may harm patients. Part II of this Article examines the ongoing debate about alternative medicine and the arguments that may wedge the door of Western medicine open to alternative treatment methods. Alternative medicine's successful entry into Western practice depends on convincing conventional medicine of the efficacy of alternative treatments, a task that remains largely undone. Part III explains why the debate about unproven alternative therapies differs from previous discussions about human research, and therefore merits independent consideration. Part IV argues that it is not ethically appropriate for physicians to offer or agree to provide alternative therapies whose efficacy remain unproven or are of dubious potential.

Type
Articles
Information
American Journal of Law & Medicine , Volume 24 , Issue 2-3 , 1998 , pp. 185 - 212
Copyright
Copyright © American Society of Law, Medicine and Ethics and Boston University 1998

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References

1 To dispel the perception that alternative medicine is nonconventional and therefore potentially dangerous, many advocate using the term complementary. See David Weber, The Mainstreaming of Alternative Medicine, HEALTHCARE FORUM J., Nov./Dec. 1996, at 16, 20. By using this nomenclature, some acknowledge that alternative medicine does not displace, but rather complements, Western or conventional medicine. See id. (citing Larry Dossey, M.D., editor of Alternative Therapies). In its study of alternative cancer treatments in the mid-eighties, the Office of Technology Assessment (OTA) chose “to describe treatments outside of mainstream medical practice and research” as unconventional treatments. OFFICE OF TECHNOLOGY ASSESSMENT, UNCONVENTIONAL CANCER TREATMENTS (SUMMARY) 1 (1990) [hereinafter OTA SUMMARY]. In choosing this term, the OTA observed: “Other terms used by proponents to describe all or some of these treatments include: alternative, complementary, nontoxic, holistic, natural, and noninvasive. Those used by the sharpest of critics include: unproven, questionable, dubious, quackery, and fraudulent.” Id. at 4. The term “traditional medicine” is “widely used to refer to various types of native healers and treatments.” Id. I do not specifically address either traditional medicine or faith healing in this Article.

2 Paul Starr describes the challenge that the first colonial physicians faced as they sought to displace their competitors: “Lay practitioners, using native herbs and folk remedies, flourished in the countryside and towns, scorning the therapies and arcane learning of regular physicians and claiming the right to practice medicine as an inalienable liberty, comparable to religious freedom.” STARR, PAUL, THE SOCIAL TRANSFORMATION OF AMERICAN MEDICINE 31 (1982)Google Scholar.

3 Andrews, Lori B., The Shadow Health Care System: Regulation of Alternative Health Care Providers, 32 Hous. L. REV. 1273, 1288-89 (1996)Google Scholar.

4 Patients who utilize complementary medicine are generally very educated consumers. See Benjamin Freedman et al., Non-validated Therapies and HIV Disease, HASTINGS CENTER REP., May-June 1989, at 14, 15. One commentator stated, “[C]ontrary to the stereotype of the uneducated, credulous patient victimized by the unscrupulous practitioner, ‘[t]he evidence seems overwhelming that socioeconomic status is either independent of the use of such therapies or that higher status and better educated individuals are over represented among the patients of unorthodox practitioners.'” Id. at 15 (quoting Cassileth, B.R. & Brown, H., Unorthodox Cancer Medicine, 38 CA-CANCER J. CLINICIANS 176 (1988)CrossRefGoogle Scholar). Reliance on unconventional providers is more significant among college graduates and those with higher incomes. See Eisenberg, David M. et al., Unconventional Medicine in the United States, 328 NEW ENG. J. MED. 246, 248 (1993)CrossRefGoogle Scholar.

5 A recent study projected that “the per capita supply of alternative medicine clinicians (chiropractors, naturopaths, and practitioners of oriental medicine) will grow by 88 percent between 1994 and 2010, while physician supply will grow by 16 percent.” Cooper, Richard A. & Stoflet, Sandi J., Trends in the Education and Practice of Alternative Medicine Clinicians, 15 HEALTH AFF. 226, 226 (1996)CrossRefGoogle Scholar. Patient visits to alternative practitioners outnumber visits to their primary care providers. See Ernst, Edzard et al., Complementary Medicine, 155 ARCHIVES INTERNAL MED. 2405, 2405 (1995)CrossRefGoogle Scholar. In 1990, for example, about one in three adults used some form of alternative therapy, spending $10.3 billion that was not reimbursed by an insurer. See Cynthia Starr, Exploring the Other Health Care Systems—Alternative Medicine: Part I, PATIENT CARE, July 15, 1997, at 134, 135. Patients seek out alternative medicine to relieve back problems, arthritis, AIDS, gastrointestinal problems, eating disorders, chronic renal failure, anxiety, headaches, chronic pain and cancer. See id. at 139; Eisenberg et al., supra note 4, at 246. “Almost 9 of 10 respondents (89 percent) who saw a provider of unconventional therapy in 1990 did so without the recommendation of their medical doctor. In more than 7 of 10 instances (72 percent), users of unconventional therapy did not inform their medical doctor of their use of the therapy.” Id. at 249.

6 See infra Part III.A.1-3.

7 See Jeffrey Kluger, Mr. Natural: Millions of Americans Swear by the Alternative Medicine of Dr. Andrew Weil, TIME, May 12, 1997 at 68, 70-71 (noting that Andrew Weil's newest book, 8 Weeks to Optimum Health, was in its eighth week on the best sellers list, that Spontaneous Healing was in its 65th week and that Deepak Chopra “has enjoyed perennial best-seller status since the 1993 publication of Ageless Body, Timeless Mind“).

8 Perhaps the most colorful of these integrative practitioners, Weil, is a graduate of Harvard College and Harvard Medical School. See WEIL, ANDREW, 8 WEEKS TO OPTIMUM HEALTH 70 (1997)Google Scholar. As a fellow of the Institute of Current World Affairs, he traveled throughout the world collecting information about medicinal plants and healing, which he now relies on extensively in his practice. See id. Dr. Weil is the founder of the Center for Integrative Medicine in Tucson, Arizona, and the director of the Program in Integrative Medicine at the University of Arizona. See id. Deepak Chopra, M.D., also a prolific author, was until recently the director of the Institute for Mind/Body Medicine and Human Potential at Sharp HealthCare in San Diego. See DEEPAK CHOPRA, AGELESS BODY, TIMELESS MIND (1993). In 1992 he became a member of the National Institutes of Health's (NIH) ad hoc panel on alternative medicine. See id.

9 David Eisenberg's 1991 study found that the majority of expenditures for alternative therapy were self-paid, with third-party payers most likely covering herbal therapy, biofeedback, chiropractic and megavitamins. See Eisenberg et al., supra note 4, at 250. This is beginning to change, however. A recent report estimates that “at least 41 state governments now require chiropractic coverage in some form; six require acupuncture coverage; and nine license naturopaths.” Managed Care Organizations Begin Covering Alternative Treatment, 12 MED. MALPRACTICE L. & STRATEGY 3, 3 (1996)Google Scholar. In 1995, Washington became the first state to enact legislation requiring health plans to reimburse medical providers for all types of medical care, including alternative medicine. See 1995 Wash. Legis. Serv. ch. 265 § 8 (West) (codified at WASH. REV. CODE § 48.43.045 (Supp. 1998)) (applicable to health plans issued or renewed after January 1, 1996). This legislation, known as the Alternative Provider Mandate Statute, reads in part, “Every health plan delivered … shall: (1) Permit every category of health care provider to provide health services or care for conditions included in the basic health plan services.” Id. This victory for alternative medicine was short-lived, however, because in May 1997, the U.S. District Court for the Western District of Washington held that the statute was preempted by the Employee Retirement Income Security Act. See Washington Physicians Serv. v. Gregorie, 967 F. Supp. 424, 431 (W.D. Wash. 1997). See generally Cohen, Michael H., Holistic Health Care: Including Alternative and Complementary Medicine in Insurance and Regulatory Schemes, 38 ARIZ. L. REV. 83, 106-09, 154-59 (1996)Google Scholar (advocating coverage of alternative medicine).

10 A recent study of physicians’ attitudes about alternative therapies revealed that more than 90% of those surveyed

considered diet and exercise, behavioral medicine, biofeedback, and counseling or psychotherapy as legitimate medical practices. More than 50 percent of physicians considered acupuncture, massage therapy, and hypnotherapy as legitimate medical practices…. At the same time, however, herbal medicine, homeopathic medicine, Native American medicine, traditional Oriental medicine, and electromagnetic applications were generally considered to be legitimate medical practice by less than 27 percent of the respondents.

Brian M. Berman et al., Physicians’ Attitudes Toward Complementary or Alternative Medicine: A Regional Survey, 8 J. AM. BOARD FAM. PRAC. 361, 362-63 (1995). However, other studies indicate that inexperienced physicians take a more optimistic view of complementary medicine. See Ernst et al., supra note 5, at 2406.

The Office of Alternative Medicine (OAM) estimates that about 30 to 100 M.D.'s in the United States practice anthroposophically extended medicine, meaning they incorporate naturopathy and homeopathy into their traditional practices. See Alternative Systems of Medical Practice—Fields of Practice (visited on Feb. 2, 1998) http://altmed.od.nih.gov/oam/what-is-cam/fields/alternative.shtml. About half of the practitioners listed in the Directory of the National Center for Homeopathy are physicians. See National Council Against Health Fraud (NCAHF) Position Paper on Homeopathy (visited Mar. 26, 1998) http://www.ncahf.org/pos-pap/homeop.html [hereinafter NCAHF Position Paper on Homeopathy]. On the other hand, although the number appears to be increasing, “only about 500 of more than 600,000 physicians use homeopathic remedies.” Mahlon W. Wagner, Is Homeopathy ‘New Science’ or ‘New Age'?, 1 SCI. REV. ALTERNATIVE MED. 7, 10 (1997). Physicians, who have long sought to eliminate the chiropractic profession, see infra notes 60-72 and accompanying text, have now been convinced of the usefulness of spinal manipulation for back pain and are increasingly inclined to offer this service to patients. One commentator recently observed:

Unless the chiropractic profession as a whole specializes in the physical treatment of back disorders … and earns reciprocity with other healing professions … there will be no justification for the existence of chiropractic when an adequate number of medical specialists and medical technicians make scientific manipulation available in a department of medical practice… . In the meantime, orthopedic specialists, neurologists, family physicians, and other medical practitioners are often compelled to refer a patient to a chiropractor for manipulation when such treatment is indicated for back pain.

Samuel Homola, Finding A Good Chiropractor, ARCHIVES FAM. MED., Jan.-Feb. 1998, at 20, 22. Samuel Homola further suggests that, even if chiropractic is determined to have value in treating disease or infection, patients may still be better off obtaining treatment in these situations from physicians who can offer alternatives if manipulative therapy does not work. See id.

11 One article describes the debate over the National Cancer Institute's (NCI) consideration of unconventional cancer treatments: “Opponents cite the unsubstantiated claims of proponents, which entice the desperate to try the treatment—regardless of the physical, emotional, and financial expense it may entail. Proponents perceive discrimination when their grant proposals fare poorly in peer review and feel persecuted when regulatory agencies investigate them.” Hawkins, Michael J. & Friedman, Michael A., National Cancer Institute's Evaluation of Unconventional Cancer Treatments, 84 J. NAT'L CANCER INST. 1699,1699 (1992)CrossRefGoogle Scholar.

12 See, e.g., infra note 68 (discussing studies that report positive outcomes in use of spinal manipulation for lower back pain). A recent randomized clinical trial suggests that ginkgo biloba extract benefits demented patients. See LeBars, Pierre L. et al., A Placebo-Controlled, Double-Blind, Randomized Trial of an Extract of Ginkgo Biloba for Dementia, 278 JAMA 1327, 1331 (1997)Google Scholar.

13 See, e.g., Green, Saul, Hydrazine Sulfate: Is It an Anticancer Agent?, 1 SCI. REV. ALTERNATIVE MED. 19 (1997)Google Scholar (providing overview of studies that conclude that hydrazine sulfate is ineffective in extending survival of cancer patients); Sampson, Wallace, The Pharmacology of Chelation Therapy, 1 SCI. REV. ALTERNATIVE MED. 23 (1997)Google Scholar (finding no proven efficacy and “no reasonable theoretical grounds for effectiveness“).

14 See Weber, supra note 1, at 20.

15 The National Council Against Health Care Fraud, Inc. (NCAHF), for example, is a private agency “that focuses upon health misinformation, fraud and quackery as public health problems” and publishes position papers on the various forms of alternative medicine available. NCAHF Goals and Objectives (visited on Feb. 6, 1998) http://www.ncahf.org/whatis.html. The American Council on Health and Science “is a consumer education consortium concerned with issues related to food, nutrition, chemicals, pharmaceuticals, lifestyle, the environment and health” and has published papers on aromatherapy, Chinese medicine and acupuncture. ACSH: Medical Care (visited on Feb. 6, 1998) http://www.acsh.org/medical/index.html. In addition, the American Cancer Society, which publishes “Unproven Methods List,” actively discourages patients from pursuing unconventional therapies. See OTA SUMMARY, supra note 1, at 3.

16 See, e.g., Sampson, Wallace, Why a New Alternative Medicine Journal?, 1 SCI. REV. ALTERNATIVE MED. 4, 5 (1997)Google Scholar (noting that the editors “find a need for a journal devoted to the rational analysis … of the ‘alternative’ system“).

17 In 1986, Rep. John Dingell (D-Mich.), Chair of the House Energy and Commerce Committee, asked the OTA to report on unconventional cancer treatments. See Fintor, Lou, OTA Report Disputes Success of Unconventional Cancer Therapies, 82 J. NAT'L CANCER INST. 1668, 1668 (1990)CrossRefGoogle Scholar. Later that same year, a group led by Congressman Guy Molinari asked OTA specifically to study Immuno-Augmentative Therapy (IAT) after an IAT clinic was closed by the Bahamanian government. See OTA SUMMARY, supra note 1, at iii, 2.

18 The OAM was instituted pursuant to congressional mandate under the 1992 NIH Appropriations Bill and “is organized under the Associate Director of Disease Prevention within the Office of the Director of the NIH.” General Information—About the OAM (visited Apr. 2, 1998) http://altmed.od.nih.gOv/oam/about/general.shtml#history. “The Congressional mandate establishing the OAM stated that the Office's purpose is to ‘facilitate the evaluation of alternative medical treatment modalities’ to determine their effectiveness.” Id. “This mandate also provides for a public information clearinghouse and a research training program.” Id. The OAM “facilitates and conducts research.” Id.

19 During the summer of 1997, OAM critics, including several prominent scientists, conducted a letter writing campaign to induce Congress to eliminate the OAM, “accusing the office of lending credibility to quackery.” Vogel, Gretchen, Senate Hears Testimony Supporting OAM, 278 SCIENCE 378,378(1997)CrossRefGoogle Scholar.

20 Senator Tom Harkin (D-Iowa), who was instrumental in OAM's creation, wants it upgraded to a National Center for Complementary and Alternative Medicine Research by tripling its $43.7 million budget. See Wadman, Meredith, Row Over Alternative Medicine's Status at NIH, 389 NATURE 652, 652(1997)Google Scholar.

21 As originally established in 1991, OAM has no independent authority to fund grants. Alternative medicine advocates argue that research proposals are subject to the bias of NIH reviewers, who do not include a single alternative practitioner, such as a chiropractor or acupuncturist. See NIH Clinical Research: Hearings Before the Subcomm. on Public Health on Safety of the Senate Comm. on Labor and Human Resources, 105th Cong. (1997) (statement of James S. Gordon, M.D.), available in 1997 WL 14152117. Currently, “there are approximately 26 standing review committees in NIH, with 125 people,” none of whom hold degrees or are licensed in any of the commonly used complementary or alternative therapies. Id.; see also Hawkins & Friedman, supra note 11, at 1699, 1700 (citing criticisms of the NCI for not funding or conducting clinical trials of unconventional cancer therapies; the authors respond that what these critics actually seek is preferential treatment for funding of scientifically unsupported claims).

22 The OTA itself observed:

[O]ne of the major rifts separating supporters of unconventional treatments from those in mainstream medical care and research is a distinct difference in what they accept as evidence of benefit.

Objective, informed examination of unconventional treatments is thus difficult, if not impossible, in the United States today. Acrimonious debate between the unconventional and mainstream communities reaches well beyond scientific argument into social, legal, and consumer issues. Sides are closely drawn and the rhetoric is often bitter and confrontational.

OTA SUMMARY, supra note 1, at 3. Legitimate questions exist not only about the appropriate methods for testing complementary medicine, but about testing genetic therapies as well. A number of issues have converged in the last few years to raise doubts about randomized clinical trials generally. For further discussion of this issue, see infra notes 135-42.

23 See Hawkins & Friedman, supra note 11, at 1700. Another researcher, John P. Vandenbroucke, criticized attempted trials of homeopathy, noting that “[t]he problem with homoeopathy is that the ‘infinite dilutions’ of the agents used cannot possibly produce any effect. A randomized trial of ‘solvent only’ versus ‘infinite dilutions’ is a game of chance between two placebos.” Jan P. Vandenbroucke, Homeopathy Trials: Going Nowhere, 350 LANCET 824, 824 (1997).

24 See Wagner, supra note 10, at 8, 10 (discussing claims that homeopathy has satisfied patients for over 200 years and should not have to meet requirements of scientific medicine).

25 See id. at 8 (discussing the suggestion that science is not relevant to evaluating homeopathy because conventional researchers refuse to accept the concept of the “vital force“); OTA SUMMARY, supra note 1, at 20 (discussing belief of some psychological practitioners and researchers that experimental methods are neither necessary nor appropriate to test their approaches); Ernst, Edzard & Kaptchuck, Theodore J., Homeopathy Revisited, 156 ARCHIVES INTERNAL MED. 2162, 2164 (1996)CrossRefGoogle Scholar (responding to claim that modern trial methods are inapplicable to homeopathy). For additional discussion, see infra text accompanying notes 81-86.

26 Samuel Benjamin, M.D., Director of the Integrative Arizona Center for Health and Medicine, who has combined his education in pediatrics with “training in Mexican indigenous healing, herbal medicine, hypnosis, and acupuncture,” is a frequent critic in this regard. Weber, supra note 1, at 21.

27 See generally Andrews, supra note 3, at 1283-89 (discussing instances of better quality of care provided by alternative providers as compared with physicians, at lower cost).

28 One could interpret In re Guess as such a case. 393 S.E.2d 833 (N.C. 1990). Guess involved a physician's appeal of the revocation of his license solely because he engaged homeopathic methods in his practice, even though no patient harm had occurred. In responding to Guess's argument that the court's decision would quash any future medical innovation, the court stated, “the development and acceptance of such new practices simply must be achieved by ‘acceptable and prevailing’ methods of medical research, experimentation, testing, and approval by the appropriate regulatory or professional bodies.” Id. at 839. In comparison, a 1980 Florida case held that the state medical board had exceeded its police power when it suspended a physician's license because of his use of chelation therapy in the absence of a demonstration of harm or fraud, and where the physician had clearly “allowed his patients to make their own choice as to whether to begin this treatment after full disclosure that this methodology has not been proven effective, … Dr. Rogers never claimed it was a cure.” State Bd. of Med. Exam'rs v. Rogers, 387 So. 2d 937, 939 (Fla. 1980). See generally Cohen, supra note 9, at 111-32 (discussing the history and litigation of homeopathy, chelation therapy, ozone therapy and other disfavored therapies, and the boundaries of chiropractic practice). The New York law governing the state board for professional medical conduct specifically provides that the board shall include at least two physicians “who dedicate a significant portion of their practice to the use of non-conventional medical treatments.” N.Y. PUB. HEALTH LAW § 230(1) (McKinney 1998).

29 Recall that the alternative medicine consumer tends to be educated and more affluent than the average patient. See supra note 4. I disagree with Andrews's suggestion that because it is the more educated and affluent among us who most frequently utilize alternative medicine, consumer protection is a less pressing concern. See Andrews, supra note 3, at 1316. For example, in Charell v. Gonzalez, 660 N.Y.S.2d 665 (Sup. Ct. 1997), the court, in determining whether plaintiff assumed the risks attendant to receiving coffee enemas rather than chemotherapy for her cancer, noted that:

Plaintiff was a well educated person who, together with her husband and daughter, did a significant amount of investigation regarding the treatment being offered by defendant and hence became quite knowledgeable on the subject, and that she sought to avoid the suffering that accompanied the chemotherapy/radiation regimen that she had witnessed when a relative had undertaken treatment.

Id. at 669. The court later indicated its awareness of the controversy between the medical profession and alternative medicine proponents, but noted that “defendant failed to produce a single witness at trial who defended his treatment of plaintiff as medically sound, whereas plaintiff's experts clearly painted him as a charlatan,” and upheld the award of punitive damages. Id. This case supports a view contrary to Andrews's, because the educated and affluent do not stand equal to the scientific and medical knowledge proffered by the “expert,” the physician, especially when ill, or in pain, and desperate for relief. Thus, I contend that some form of consumer protection remains necessary in this area.

30 External pressures to integrate alternative therapies into conventional medicine are coming from consumers, who are now spending $13 billion per year on alternative treatment. See Lynna Goch, Alternative Medicine Moves into the Mainstream, BEST's REVIEW, Mar. 1997, at 84, 84. Some health maintenance organizations (HMOs), interested in cost-effectiveness, favor alternative procedures; a growing number of states license chiropractors, acupuncturists and naturopathic physicians. See id. In addition, many corporations seeking to reduce health care costs have focused on wellness and prevention programs for their employees. See Howard Fine, Hospitals, HMOs Embracing Preventive Medicine, L.A. Bus. J., Sept. 22, 1997, at 23, 23. Such programs include the utilization of alternative therapies such as acupuncture and massage. See id.

31 I do not address physicians charging patients for their provision of alternative therapies, but it is an extremely important subject that encompasses two different issues. The first issue is outright fraud: charging for invalidated treatments, that the physician knows will do the patient absolutely no good. The second issue is more difficult: charging patients for nonvalidated treatments, even with sufficiently informed consent. Most attention in this area seems to focus on concerns about fraud. The NCAHF accused homeopathy of providing a haven to untrustworthy and incompetent practitioners. See NCAHF Position Paper on Homeopathy, supra note 10. Physician fraud can become an issue in malpractice cases. In Charell v. Gonzalez, the plaintiff “offered evidence to show that defendant's practice of prescribing nutrition as a cure was designed to enable companies in which he had a financial interest to sell product.” 660 N.Y.S.2d at 669. Some physician licensing boards find it easier to respond to concerns about physicians’ alternative therapeutic offerings by focusing on their billing practices rather than grappling with the efficacy of their treatments. See, e.g., Catena v. Commonwealth, 411 A.2d 869, 873 (Pa. Commw. Ct. 1980) (holding that a medical licensing board could suspend a physician's license on Medicare fraud grounds after physician prescribed “inadequate treatment” to treat patient's obesity). Aware of this, some are concerned that the widely heralded Health Insurance Portability and Accountability Act of 1996 (HIPAA), enacted in part to reduce billing fraud, see 42 U.S.C.A. § 1320a-7c (West Supp. 1998), will lead to widespread criminal prosecution of alternative medicine providers. See Physicians May Fall Prey to Quack Busters, VEGETARIAN TIMES, May 1, 1997, at 18, 18. The concern apparently arose even before HIPAA's passage, as the Conference Report specifically states that the practice of alternative or investigative medicine is not itself fraudulent. See H.R. CONF. REP. No. 104-736, at 258 (1996). The conferees further stated that Congress did not intend HIPAA to prohibit the practice of “complementary, alternative, innovative, experimental, or investigational [medicine].” Id. In addition:

The Act is not intended to penalize a person who exercises a health care treatment choice or makes a medical or health care judgment in good faith simply because there is a difference of opinion regarding the form of diagnosis or treatment. Nor does this provision in general prohibit plans from covering specific types of treatment. Whether certain complementary and alternative practices will be covered is and should be a decision left to the health care plan administrators.

Id.

32 According to the Health Insurance Association of America, several states require insurance companies to cover various alternative therapies, such as chiropractor and naturopath services. See Gina Kolata, On Fringes of Health Care, Untested Therapies Thrive, N.Y. TIMES, June 17, 1996, at Al. Oxford Health Plans allows patients to go directly to its “new specialists,” who include chiropractors, acupuncturists, naturopathic doctors, massage therapists, nutritionists and yoga instructors, without getting approval from a primary care physician. See Vincler, Lisa A. & Nicol, Mary F., When Ignorance Isn't Bliss: What Healthcare Practitioners and Facilities Should Know About Complementary and Alternative Medicine, 30 J. HEALTH & HOSP. L. 160, 163 (1997)Google Scholar.

33 It is estimated that in the United States alone approximately 50% of cancer patients use alternative medicine, usually with conventional treatments, at a cost of about $25 billion per year. See Holzman, David, Green Tea, Mistletoe, and More: Canadians Test Alternative Cancer Therapies, 89 J. NAT'L CANCER INST. 683, 683 (1997)CrossRefGoogle Scholar.

34 See Berman et al., supra note 10, at 363.

35 More than 30 medical schools have added alternative medicine to their curricula. See Starr, supra note 5, at 136.

36 See Dumoff, Alan, Malpractice Liability of Alternative/Complementary Health Providers: A View from the Trenches (Part 2), 5 ALTERNATIVE & COMPLEMENTARY THERAPIES 333, 334 (1995)CrossRefGoogle Scholar. According to Alan Dumoff, MCOs have instituted procedures to ensure that alternative health care providers have the requisite state credentials to practice alternative medicine. See id. Furthermore, MCOs also require that alternative care providers be accredited by other private organizations, including the National Commission for the Certification of Acupuncturists. See id. For elaboration on the history of physician credentialing in HMOs, see generally Blum, John D. The Evolution of Physician Credentialing into Managed Care Selective Contracting, 22 AM. J.L. & MED. 173, 176-78 (1996)CrossRefGoogle Scholar (surveying the credentialing process); Ruth A. Mickelsen, Provider Selection and De-Selection, NAT'L HEALTH LAW. ASS'N MANAGED CARE L. INST., Dec. 11-13, 1996 (describing the selection and deselection process of physicians in managed care).

37 This paper does not address the provision of alternative therapies by alternative practitioners, which has been thoroughly addressed by Michael Cohen. See Cohen, Michael H., A Fixed Star in Health Care Reform: The Emerging Paradigm of Holistic Healing, 27 ARIZ. ST. L.J. 79 (1995)Google Scholar. Nor does it address the scope of practice issues raised by advanced nurse practitioners (APNs), physicians’ assistants, and other nonphysician practitioners who are generally associated with “conventional medicine.” See, e.g., Andrews, supra note 3, at 1275 (focusing on physician assistants, podiatrists, chiropractors, and APNs, including midwives and nurse anesthetists); Safriet, Barbara J., Health Care Dollars and Regulatory Sense: The Role of Advanced Practice Nursing, 9 YALE J. ON REG. 417 (1992)Google Scholar (arguing that APNs can increase provision of health care and preserve quality while reducing costs); see also Lay, Betty F., Healer-Patient Privilege: Extending the Physician- Patient Privilege to Alternative Health Practitioners in California, 48 HASTINGS L.J. 633 (1997)Google Scholar (discussing whether a patient can invoke the physician-patient privilege with respect to communication with an alternative health care provider).

38 I do not substantively address the payment issue in this Article, but see supra notes 31-32.

39 In Ahem v. Veterans Administration, for example, the court treated as “experimental” the defendant physician's daily administration of 700 Rads of radiation to the plaintiff, when neither the literature nor any other evidence of the standard of care supported administering more than 200-250 Rads per day. 537 F.2d 1098, 1099-100 (10th Cir. 1976). In fact, the court observed that “[t]he giving of seven hundred (700) Rads a day was not in accordance with anybody's standard.” Id. at 1101. As such, the court held that “in order for a physician to avoid liability by engaging in drastic or experimental treatment, which exceeds the bounds of established medical standards, his patient must always be fully informed of the experimental nature of the treatment and of the foreseeable consequences of the treatment.” Id. at 1102.

40 The terms used in this Article are prone to analytic confusion. See generally Nancy M.P. King, Experimental Treatment: Oxymoron or Aspiration, HASTINGS CENTER REP., July-Aug. 1995, at 6, 9 (discussing analytic confusion created by referring to therapies still in the experimental or research stages as either therapy or treatment). The term practice used in conventional medicine refers to “interventions that are designed solely to enhance the well-being of an individual patient or client and that have a reasonable expectation of success.” Protection of Human Subjects; Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research, Report of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, 44 Fed. Reg. 23192, 23,193 (1979). However, the general term practice as used in this Article neither connotes that the activity is proven or unproven (validated or nonvalidated) nor denotes whether the practitioner is conventional or alternative.

41 Benjamin Freedman has proposed a useful definition for nonvalidated therapies which, though not entirely applicable to alternative medicine, provides a useful starting point:

[N]onvalidated therapies [are] those drugs, medical and surgical interventions, and regimens that are offered to and accepted by a patient on the basis of potential benefit, and that have neither been accepted nor discredited by the expert clinical community. Nonvalidated therapies are distinct from, on the one hand, customary and accepted treatments; and, on the other, quack remedies.

Benjamin Freedman et al., supra note 4, at 14.

42 Nancy King provides a very helpful distinction among experimentation, treatment and what she calls “experimental treatment.” See King, supra note 40, at 9. Medical research has been defined to include “a class of activities designed to develop or contribute to generalizable knowledge and generalizable knowledge consists of theories, principles, or relationships (or the accumulation of data on which they may be based) that can be corroborated by accepted scientific observation and inference.” Vodopest v. MacGregor, 913 P.2d 779, 785-86 (Wash. 1996) (en banc).

43 Eisenberg and his colleagues found, in fact, that “a substantial amount of unconventional therapy is used for nonserious medical conditions, health promotion, or disease prevention.” Eisenberg et al., supra note 4, at 251.

44 See generally Annas, George J., Faith (Healing), Hope and Charity at the FDA: The Politics of AIDS Drug Trials, 34 VILL. L. REV. 771 (1989)Google Scholar (discussing the importance of the difference between experimentation and therapy in AIDS drug development); Capron, Alexander Morgan, Informed Consent in Catastrophic Disease Research and Treatment, 123 U. PA. L. REV. 340 (1974)CrossRefGoogle Scholar (discussing how informed consent for patients in catastrophic disease research differs from informed consent for patients in nonterminal illness research); King, Nancy M.P. & Henderson, Gail, Treatments of Last Resort: Informed Consent and the Diffusion of New Technology, 42 MERCER L. REV. 1007 (1991)Google Scholar (discussing the doctor's responsibility in offering experimental technologies and the patient's ability to make an informed decision regarding these technologies in catastrophic disease situations).

45 It is not clear that one can ever feel confident that the pursuit of nonvalidated alternative therapy does not represent some level of risk to the patient.

46 “The gold standard of clinical research is ‘the randomized, double-blind trial’ in which patients are divided at random into two groups.” Clive Cookson & Victoria Griffith, Technology: Complementary Approach, FIN. TIMES, Aug. 4, 1995, at 14. Each group then receives a different treatment. See id. Neither patients nor researchers know which group has received the alternative treatment and which one has received the placebo until the study has been concluded. See id.

47 A recent randomized double-blind study proved oral homeopathic immunotherapy to be more effective than placebo in 28 asthma patients. See Reilly, David et al., Is Evidence for Homeopathy Reproducible?, 344 LANCET 1601, 1605 (1994)CrossRefGoogle Scholar. On respiratory function tests, 7 of 9 patients (77%) on homeopathic therapy showed improvement compared with 4 of 11 patients (36%) on placebo. See id. at 1604. In addition, German researchers found the herb St. John's Wort (hypericum perforatum) to be as effective as synthetic antidepressants, such as Prozac. See Michael T. Murray, Battling the Blues with St. John's Wort, BETTER NUTRITION, Feb. 1998, at 15, 15.

48 See Ernst & Kaptchuck, supra note 25, at 2162.

49 See Wagner, supra note 10, at 7.

50 See Robert L. Park, Alternative Medicine and the Laws of Physics, SKEPTICAL INQUIRER, Sept.-Oct. 1997, at 24, 25.

51 National Council Against Health Care Fraud Position on Homeopathy, 17-2 NCAHF NEWSLETTER (Mar.-Apr. 1994) (visited Apr. 2,1998) http://www.ncahf.Org/newslett/nll7-2.html#fraud.

52 Substances include

[R]aw bovine testicles, crushed honey bees (Apis mellifica), Belladonna (deadly nightshade), cadmium, sulfur, poison nut (Nux vomica), hemlock (Conium), silica (Silicea), monkshood (Aconite), salt (Natrium mur), mountain daisy (Amica), venom of the Bushmaster snake (Lachesis), arsenic (Arsenicum album), Spanish fly (Cantharis), rattlesnake venom (Crotalus horridus), Ipecac (Ipecacuahna), dog milk (Lac canidum), poison ivy (Rhus toxicoendron), and more.

Wagner, supra note 10, at 7-8.

53 See Park, supra note 50, at 25.

54 NCAHF Position Paper on Homeopathy, supra note 10. The remedies become more powerful through a process called “potentization.” See Ernst & Kaptchuck, supra note 25, at 2162.

55 See Wagner, supra note 10, at 7.

56 See Park, supra note 50, at 26.

57 See Ernst & Kaptchuck, supra note 25, at 2162.

58 See Park, supra note 50, at 26; see also Wallace Sampson, Inconsistencies and Errors in Alternative Medicine Research, SKEPTICAL INQUIRER, Sept.-Oct. 1997, at 35, 35-36 (discussing studies on the effectiveness of homeopathic or “alternative” therapies).

59 See Park, supra note 50, at 26.

60 See Ernst & Kaptchuck, supra note 25, at 2163 (stating that “every one of the cardinal principles of homeopathy can be shown to be out of line with accepted knowledge“).

61 See generally Ernst & Kaptchuck, supra note 25, at 2163-64 (summarizing the homeopathic therapy literature and noting that no study has been able to duplicate the findings of any of the positive homeopathy trials); Sampson, supra note 58, at 35-38 (stating that homeopathic studies are defective and their results inconclusive); Wagner, supra note 10, at 8-9 (discussing that many studies on homeopathic remedies have been conducted over the past fifteen years and yet there is no conclusive proof that homeopathic remedies are effective); NCAHF Position Paper on Homeopathy, supra note 10 (summarizing the extant scientific literature on homeopathy).

62 Approximately 10% of Americans have used chiropractic services. See Evelyn Gilbert, Chiropractors’ Popularity Prompts Product Launch, NAT'L UNDERWRITER PROP. & CASUALTY-RISK & BENEFITS MGMT., Sept. 18, 1995, at 21, 21. “Chiropractic is the largest drug-free health-care profession in the country, with about 50,000 doctors of chiropractic (D.C.s) treating millions of patients in the United States.” Greg Beaubien, Image Adjustment: Chiropractors Gain Acceptance in the Medical Field, BUFFALO NEWS, Mar. 28, 1995, at C3, available in 1995 WL 5461039.

63 The main organ for the elimination of chiropractic treatment was the American Medical Association's (AMA) Committee on Quackery, which was formed in 1962. See OTA SUMMARY, supra note 1, at 3. In Wilk v. American Medical Ass'n, 895 F.2d 352, 355 (7th Cir. 1990), four licensed chiropractors sued the AMA and other professional organizations for conspiring to restrain the trade of chiropractors. The alleged conspiracy involved, among other things, a provision in the AMA's principles of medical ethics banning physician affiliations with chiropractors. See id. In 1987, a federal judge issued a permanent injunction against the AMA. See id. In 1990, the AMA eliminated its ban on affiliation, and in 1991, the AMA paid the chiropractors $53.5 million in legal costs. See David Burda, AMA Conspiracy Case Comes to an End, MODERN HEALTHCARE, Dec. 3, 1990, at 14, 14. Following the Wilk decision, the AMA disbanded the Committee on Quackery. See OTA SUMMARY, supra note 1, at 3. See generally Andrews, supra note 3, at 1291-96 (discussing the numerous efforts the AMA has undertaken to quash alternative practitioners and the minimal legal success alternative practitioners have had in bringing antitrust suits against the AMA).

64 A recent spate of studies on the efficacy of manipulation for lower back pain, including a federal Agency for Health Care Policy and Research study, partially explains the surge of referrals by physicians to chiropractors. See Weis, Gerald R., Chiropractic Referrals Reduce Neuromusculoskeletal Health Care Costs, 23 J. HEALTH CARE FIN. 88, 88-89 (1996)Google Scholar. These studies are also causing MCOs to be more solicitous toward chiropractic care. See id. at 89.

65 See Colgate, Margaret A., Gaining Insurance Coverage for Alternative Therapies, 15 J. HEALTH CAREMKTG. 24, 25(1995)Google Scholar.

66 See id.

67 All 50 states have chiropractic licensing boards and licensing requirements. See id. at 24. In addition, four-year chiropractic colleges are recognized by the U.S. Department of Education. See id.

68 A recent article summarizing the literature on spinal manipulation and back pain states:

In 1991, RAND, a nonprofit research organization, published the first of a 4-part report on the effectiveness, complications, and indications for spinal manipulation for back pain. This multidisciplinary review of the literature on back pain supported the use of spinal manipulation as a treatment for patients with acute low back pain without symptoms of lower limb nerve-root involvement and other contraindicating signs…. Support in the literature was less clear, insufficient, or conflicting for the use of spinal manipulation in treating subacute and chronic back pain, with or without neurologic findings or sciatica C indicating a great need for additional research. Reporting similar findings, the Agency for Health Care Policy and Research of the US Department of Health and Human Services published a report that concluded that, in the absence of red flags, “manipulation can be helpful for patients with acute low back problems without radiculopathy when used within the first month of symptoms.“

Homola, supra note 10, at 21. See generally NCAHF Position Paper on Chiropractic (visited Apr. 2, 1998) http://www.ncahf.org/pos-pap/chirop.html (summarizing clinical articles establishing efficacy of manipulative therapy).

69 See Homola, supra note 10, at 20. Physicians complain that chiropractic continues to be defined as a “method of restoring and maintaining health rather than as a method of treating back pain.” Id. at 21. 70 See id. Existing data neither support nor refute spine manipulation for “cervical curvatures; migraine headache; shoulder, arm and hand pain; cervical disc herniation; torticollis; infantile colic; and otitis media.” Id. at 22.

71 Chiropractic care provides no benefit for many ailments, and in some cases may exacerbate the patient's problem. See Rick Weiss, Bones of Contention, HEALTH, July/Aug. 1993, at 44, 46. The RAND report found that over 57% of cervical spine manipulations by chiroprators were inappropriate. See Homola, supra note 10, at 22.

72 According to Reed Phillips, president of the Los Angeles College of Chiropractic, recent studies provide no support for the use of x-rays by chiropractors for most cases of low back pain. See Weiss, supra note 71, at 46.

73 Chiropractic practitioners fall into different schools. Neofundamentalists “take a holistic, preventive approach to health and believe they can treat far more than back pain.” Chiropractic Manipulation, HARV. WOMEN's HEALTH WATCH, Dec. 1995, at 4, 5. Revisionists “seek to recast chiropractic in the image of medical science, concentrating on spinal mechanics and back pain.” Id.

74 Some chiropractors also practice naturopathy, which:

may include shining colored light on the patient (i.e., chromotherapy) on the theory that red … might be used in ailments of the blood … orange is helpful in fevers … yellow rays aid stomach troubles, and so forth… . Naturopaths prescribe megavitamins and herbs, either of which may function as drugs, belying the claim that their therapies are “drugless” or benign. Naturopaths tend to emphasize colonics based upon the discredited nineteenth century “intestinal toxicity” theory.

NCAHF Position Paper on Chiropractic, supra note 68. The NCAHF has proposed a sort of code of behavior to which it believes the “scientific chiropractor” should adhere (except for experimental work under conditions of complete disclosure and appropriate protocols, which the code permits).

Utilizing] unproven, disproven or questionable methods, devices, and products such as adjusting machines, applied kinesiology, chelation therapy, colonic irrigation, computerized nutrition deficiency tests, cranial osteopathy, cytotoxic food allergy testing, DMSO, gerovital, glandular therapy, hair analysis, herbal crystalization analyses, homeopathy, internal managements, iridology, laser beam acupuncture, laetrile, magnetic therapy, Moire contourographic analysis, Neurothermograph, orthomolecular therapy, pendulum divination, pyramid power, “Reams” test, reflexology, scleraglyphics, Spinal column stressology, Thermography Thermoscribe, Toffhess device, and so forth.

NCAHF Position Paper on Chiropractic, supra note 68.

75 Starr, supra note 5, at 141.

76 See id. at 143.

77 See NCAHF Position Paper on Acupuncture (visited Apr. 2, 1998) http://www.ncahf.org/pos-pap/acupunct.html.

78 Id.

79 See Starr, supra note 5, at 158.

80 Sampson, supra note 58, at 38 (citations omitted).

81 As recently reported:

The popularity of herbal medications as adjunctive therapy for acute and chronic medical problems has grown significantly in the past several years. US herb sales in 1996 were expected to reach or exceed $12 billion. In a recent survey of 1,008 adults, 63% predicted herbs would be a part of their daily regimen within 5 years.

Nancy Spaulding-Albright, A Review of Some Herbal and Related Products Commonly Used in Cancer Patients, 97 J. AM. DIETETIC Ass'N at S208, S208 (1997).

82 According to one critic:

Diets that are alleged to be effective as treatments for cancer have been variously referred to as nutritional, enzyme, metabolic, holistic, macrobiotic, nontoxic, and oxidative therapies. All advocate the use of “all natural foods,” grown without the use of pesticides or chemical fertilizers and prepared without added sugar, starch, salt, artificial coloring, or preservatives. These diets may be supplemented with megadoses of vitamins … laetrile, minerals, enzymes, amino acids, and oxygen generating chemicals.

Saul Green, A Critique of the Rationale for Cancer Treatment with Coffee Enemas and Diet, 268 JAMA 3224, 3224 (1992). The Gerson treatment, which consists of coffee enemas combined with a special diet, is one of the more controversial nutritional programs for the treatment of cancer. See id.

83 See generally Center for Research in Complementary and Alternative Medicine for Stroke & Neurological Disorders, Resource List for Alternative Therapies (visited on Oct. 2, 1997) http://www.umdnj.edu/altmedweb/orglist.html.

84 See Hawkins & Friedman, supra note 11, at 1701.

85 See Alternative Medicine Research Using MEDLINE—What Is CAM? (visited Apr. 2, 1998) http://altmed.od.nih.gov/oam/what-is-cam/medline.shtml (referring to complementary and alternative medicine).

86 Daniel Cattau, All You Really Need is Chi, PARK RIDGE CENTER BULL., Nov./Dec. 1997, at 6, 8.

87 See Vincler & Nicol, supra note 32, at 161.

88 See Barry L. Beyerstein, Why Bogus Therapies Seem to Work, SKEPTICAL INQUIRER, Sept.- Oct. 1997, at 30.

89 See generally Andrews, supra note 3 at 1280 (stating that patients may prefer alternative providers over conventional medical providers because of the better quality, greater sensitivity, and better communication offered by alternative providers).

90 See Oppenheimer, David B., Understanding Affirmative Action, 23 HASTINGS CONST. L.Q. 921, 978 (1996)Google Scholar (citing ECONOMICS AND STATISTICS ADMIN., BUREAU OF THE CENSUS, STATISTICAL ABSTRACT OF THE UNITED STATES: 1994, at 393, 407-10 (1994)). Only 7% of all practicing physicians and 10% of all medical students are black, Latin or American Indian. See Harold W. Hartman & Margarita Catherine Reyes, Will Health Care Reform Give Minorities a Fair Shake?, HOSP. & HEALTH NETWORKS, Aug. 20, 1994, at 64, 64. This lack of minority physicians contributes to the cultural barriers that can compromise the care of minority patients. See id. In addition, physicians sometimes pay insufficient attention to the emotional needs of their patients. See Stephen Barrett, Alternative Medicine: More Hype Than Hope, CHI. SUN-TIMES, July 26, 1993, at 11, available in 1993 WL 6540668.

91 See Joy Elizabeth|Matak, Telemedicine: Medical Treatment Via Telecommunications Will Save Lives, but Can Congress Answer the Call?: Federal Preemption of State Licensure Requirements Under Professional Commerce Clause Authority and Spending Power, 22 VT. L. REV. 231,236(1997)Google Scholar.

92 According to unpublished data from the Office of Shortage Designation of the Department of Health and Human Services (DHHS), in 1994, there were 2663 shortage areas in the United States designated as having less than one primary care physician per 3500 people, comprising 47 million Americans or 19% of the U.S. population. See Schroeder, Steven A. & Beachler, Michael P., Physician Shortages in Rural America, 345 LANCET 1001, 1001 (1995)CrossRefGoogle Scholar. In terms of geography, because of the paucity of health care providers in predominantly minority neighborhoods, minorities have difficulty in obtaining care, and have little choice when they do obtain care. See Watson, Sidney D., Race, Ethnicity & Hospital Care: The Need for Racial and Ethnic Data, 30 J. HEALTH & HOSP. L. 125, 125 (1997)Google Scholar [hereinafter Watson, Race, Ethnicity, & Hospital Care]; see also Watson, Sidney D., Health Care in the Inner-City: Asking the Right Question, 71 N.C. L. REV. 1647, 1651 (1993)Google Scholar (describing America's segregated health care system).

93 See Boozang, Kathleen M., An Intimate Passing: Restoring the Role of Family and Religion in Dying, 58 U. PITT. L. REV. 549, 585 (1997)Google Scholar. Cultural and religious practices will affect the types of health care practice that patients will seek, such as folk medicine or other nontraditional alternatives. Consequently, studies on health care providers have shown that there are cultural and ethnic differences in what types of services are used by patients. When minorities do seek care, poor communication may undermine care if majority health care professionals do not understand other cultures’ deference to authority, descriptions of pain, and world views about wellness and illness. See Watson, Race, Ethnicity & Hospital Care, supra note 92. Often, because of culturally insensitive delivery of health care, no effort is made by health care professionals to interact with the patient effectively.

94 See Park, supra note 50, at 24.

95 Because I focus on nonproven alternative therapies, I assume that the physician has no obligation under the doctrine of informed consent to offer the treatments to patients as a viable choice of care.

96 See generally Capron, supra note 44 (discussing the importance and difficulties of physician disclosure in obtaining informed consent for treatment of catastrophic disease); King & Henderson, supra note 44, at 1032-50 (discussing physicians’ responsibility to disclose experimental treatments to patients in obtaining informed consent).

97 See King & Henderson, supra note 44, at 1040.

98 See id. at 1041.

99 See generally King, supra note 40 (arguing for the elimination of the distinction between experiment and treatment and for physicians to use “meaningful justification” instead of recommendations to patients).

100 See King & Henderson, supra note 44, at 1041-46.

101 See King, supra note 40, at 8 (noting that research regulation substantially derives from concerns “that physician-researchers may deliberately or inadvertently misrepresent their intent,” with patients unwittingly becoming research subjects).

102 The controversy centered on whether AIDS patients, whose disease at the time was inevitably fatal and for which treatment was unknown, could obtain accelerated access to unapproved drugs. See George J. Annas, AIDS, Judges, and the Right to Medical Care, HASTINGS CENTER REP., Aug.-Sept. 1988, at 20, 22. At the time, large numbers of AIDS patients were smuggling experimental drugs into the country from Mexico, Europe and Japan in their search for anything that offered hope. See Booth, William, An Underground Drug for AIDS, 241 SCIENCE 1279, 1280(1988)CrossRefGoogle Scholar.

103 21 C.F.R. § 312.34(a) (1997).

104 See generally, Annas, supra note 44, at 782-96. George Annas argued that the new regulations increased access to “quack” remedies. See id. at 793, 796-97. However, this also served consumers by speeding up the bureaucratic aspects of drug testing. See id. at 793.

105 See 21 C.F.R. § 312.34(b)(1)(i).

106 See id. § 312.34(b)(1)(ii).

107 See id. § 312.34(b)(2).

108 See id. § 312.34(b)(3)(i)(A).

109 See id. § 312.34(b)(3)(i)(B).

110 See MICHAEL H. COHEN, COMPLEMENTARY & ALTERNATIVE MEDICINE: LEGAL BOUNDARIES AND REGULATORY PERSPECTIVES 73-86, 112-14 (1998).

111 See id. at 77, 79.

112 Alternare Group of Seattle has created one of the larger alternative care networks in Washington, Alaska and Chicago and provides access to a host of alternative specialists as well as a variety of food and herbal supplements. See Weber, supra note 1, at 16, 18. In Northern California, alternative care is available through Kaiser Permanente at a physician-directed alternative medicine clinic. See id. at 19. Deepak Chopra, M.D., collaborated with Sharp Healthcare in San Diego to establish an Institute for Human Potential and Mind/Body Medicine. See id. The Sisters of Charity of Nazareth Health System is preparing to train staff in Kentucky, Arkansas and Tennessee in reflexology, reiki, herbology and other healing methods. See id. On the east coast, Oxford Health Plans announced in October 1996 its plans for an alternative health care network to include: natural remedy, Chinese herbology, t'ai chi, body energy techniques and meditation and hypnotherapy. See Lucette Lagnado, Oxford to Create Alternative-Medicine Network, WALL ST. J., Oct. 7, 1996, at B9. Although Oxford's recent financial difficulties would seem to jeopardize such a new venture, see Pat Wechsler, Healing Oxford's Wounds, BUS. WK., Feb. 16, 1998, at 46, 46, which states that Oxford needs both a new management team and an outside investment of $100 to $200 million and Ron Winslow, Can a Number Cruncher Save Oxford?, WALL ST. J., Feb. 19, 1998, at Bl, which describes the challenges facing Oxford's new chief executive officer. Oxford continues to push its alternative health care program. See Ron Winslow, Oxford Launches Turnaround Plan, Taps Payson, WALL ST. J., Feb. 25, 1998, at A3; Oxford Advertisement, N.Y. TIMES, Mar. 5, 1998, at A25 (Oxford continues to advertise “the first alternative medicine program to offer a fully credentialed network of alternative care providers“); see also Susan Jackson, Not Everything Oxford Did Needs Repair, Bus. WK., Mar. 9, 1998, at 38, 38 (noting that alternative medicine costs Oxford little and remains a source of positive publicity).

113 See generally Warren, David G., Book Review, 18 J. LEGAL MED. 257, 257 (1997)CrossRefGoogle Scholar (reviewing JULIE STONE & JOAN MATTHEWS, COMPLEMENTARY MEDICINE AND THE LAW (1996) which states that, because consumers view MCOs as cost saving operations, their acceptance of alternative therapies reassures patients that they are effective).

114 Oxford Health Plans, in conjunction with Columbia University College of Physicians and Surgeons, sponsored an alternative medicine program for physicians at the Waldorf Astoria in New York City, on Oct. 22, 1997. David M. Eisenberg, M.D., Assistant Professor of Medicine at Harvard University and Director of the Center for Alternative Medicine Research at Beth Israel Medical Center in Boston, was a keynote speaker at the program. Eisenberg acknowledged that doctors will undoubtedly face questions of their own liability in recommending alternative therapies to patients. See Eisenberg, David M., Advising Patients Who Seek Alternative Medical Therapies, 127 ANNALS INTERNAL MED. 61, 61 (1997)CrossRefGoogle Scholar. Eisenberg asked, “Will I be sued if I knowingly comanage a patient who seeks an alternative therapy practitioner and experiences a bad outcome from that therapy?” Id.

115 Alternative treatments are frequently less expensive than conventional offerings. See Jonas, Wayne, Alternative Medicine and the Conventional Practitioner, 279 JAMA 708, 708 (1998)CrossRefGoogle Scholar.

116 Oxford Health Plans “requires nontraditional practitioners to submit a care plan for each member for pre-approval before extensive treatment begins,” although the gatekeeper method will not apply for visits to chiropractors, acupuncturists or naturopaths. Managed Care Organizations Begin Covering Alternative Treatment, supra note 9, at 3. Eisenberg warns that medical doctors have been sued for malpractice as a result of administering unproven treatments, but observes that extant case law fails to guide physicians who desire to provide or refer patients to receive alternative health care. See Eisenberg, supra note 114, at 61. Eisenberg himself outlines a strategy for physicians to follow in supervising a patient's alternative medical treatments. See id. at 62-65.

117 Members of Blue Cross managed care plans in Washington and Alaska must seek a referral to an alternative practitioner from their gatekeeper primary care physician. See Weber, supra note 1, at 18.

118 Nancy King observes:

Whereas patients and physicians prefer the physician's individual therapeutic intuition to govern insurer reimbursement decisions, insurers are increasingly attempting to curb their responsibility to pay for treatments that are often both extremely costly and unlikely to succeed by seeking to apply more “scientific” definitions and standards of acceptability.

King, supra note 40, at 8. Michael Cohen argues that alternative/complementary medicine should not be treated as experimental therapies by third-party payers. See Cohen, supra note 9, at 157-59.

119 See, e.g., Joliff v. Aetna Ins. Co., No. 89AP-298, 1989 WL 153571, at *1 (Ohio Ct. App. Dec. 19, 1989) (challenging insurer's refusal to cover chelation therapy for treatment of cardiovascular disease).

120 See, e.g., Green, supra note 82, at 3224 (criticizing the underlying science of Gerson's work (citing M. GERSON, A CANCER THERAPY: RESULTS OF FIFTY CASES (3d ed. 1977)); see also Green, Saul, Outline of Principles and Criteria for Research and Evaluation of New Medicines, 1 SCI. REV. ALTERNATIVE MED. 32 (1997)Google Scholar; Saul Green, Pseudoscience in Alternative Medicine, SKEPTICAL INQUIRER, Sept.-Oct. 1997, at 40 (describing several instances where physicians provided alternative therapies where there was no scientific evidence to support such treatments).

121 I suggest elsewhere that strict adherence to the randomized clinical trial methodology may not be necessary or appropriate to alternative medicine, but that some scientifically valid proof must exist. See discussion infra Part V.B.

122 Beyerstein, supra note 88, at 30.

123 See generally Walter A. Brown, The Placebo Effect, SCI. AM., Jan. 1998, at 90 (discussing the effects of placebos).

124 See OTA SUMMARY, supra note 1, at 3. Some cancer patients, for example, seek out alternative practitioners because they want “humane and caring and psychological support from care givers … . These are elements that at least some patients believe are missing from mainstream medicine.” Id.

125 “Many people are dissatisfied with the medical establishment … ; consumers seek out unconventional healers because they think their problems will be taken more seriously, and they receive the benefit of time and attention.” Campion, Edward W., Why Unconventional Medicine?, 328 NEW ENG. J. MED. 282, 283 (1993)CrossRefGoogle Scholar.

126 See OTA SUMMARY, supra note 1, at 3.

127 See id. “Effective treatments are lacking for many cancers,” so many patients are looking for “a hopeful prognosis” by seeking out alternative medicine treatments. Id.

128 See, e.g., Hall v. Hilbun, 466 So. 2d 856 (Miss. 1985) (discussing physicians’ duty to “use their knowledge and therewith treat through maximum reasonable medical recovery, each patient, with such reasonable diligence, skill, competence, and prudence as … physicians in the same … general field of practice“); PRINCIPLES OF MED. ETHICS, AM. MED. ASS'N CODE OF MED. ETHICS at xiv (1996-1997 ed.) (describing physicians’ responsibility to provide “competent medical services“).

129 Some innovative therapies that originally were considered “miracle cures,” but later turned out to be harmful to patients, include ritalin, diethylstilbestrol (DES), thalidomide, laetrile and ribavirin. DES and thalidomide caused serious harm to fetuses when ingested by women during pregnancy. See Berger, Margaret A., Eliminating General Causation: Notes Towards a New Theory of Justice and Toxic Torts, 97 COLUM. L. REV. 2117, 2118 n.4 (1997)CrossRefGoogle Scholar. In the United States, the Food and Drug Administration (FDA) banned laetrile for cancer and ribavirin for AIDS, both of which were considered “miracle drugs.” See Piffat, Kathryn A., Note, Liability for Injuries Caused by Unapproved Pharmaceuticals Marketed to U.S. Consumers Abroad, 7 B.U. INT'L L.J. 155, 155 (1989)Google Scholar; see also Charell v. Gonzalez, 660 N.Y.S.2d 665, 666 (Sup. Ct. 1997) (holding defendant medical practitioner liable for patient's recurrence of cancer, which resulted in blindness and severe back problems when defendant persuaded patient to treat uterine cancer with coffee enemas and a special diet and to forgo radiation and chemotherapy).

130 See generally Jonas, supra note 115, at 708 (discussing the risks of complementary medicine).

131 See, e.g., Boyle v. Revici, 961 F.2d 1060, 1062 (2d Cir. 1992) (finding that surgery would have given patient a very good chance of recovery, but she elected nonconventional therapy and died).

132 See Wagner, supra note 10, at 9.

133 See Listening to St. John's Wort, HARV. HEALTH LETTER, Nov. 1, 1997, at 3, 3 (warning that one should not take St. John's Wort with any other antidepressant, including Prozac); Joe Graedon & Teresa Graedon, Teacher's Advice Is Helpful but Ask Pros About Ritalin, BALTIMORE SUN, Oct. 21, 1997, at 5E (noting that the interactive effects between Prozac and St. John's Wort are currently unknown); cf. Stephan Herrera, When Drugs Don't Mix, FORBES, Feb. 9, 1998, at 100-01 (warning of the possibility of liver damage caused by taking St. John's Wort with other medicines); Sue MacDonald, Fighting Depression the Herbal Way: More People Are Trying Non-Prescription St. John's Wort, but Experts Urge Caution, CINCINNATI ENQUIRER, Nov. 21, 1997, at El (cautioning against possible side-effects and potential interactions with other drugs or medicines). Although taking St. John's Wort typically does not result in the side-effects of Prozac, including loss of libido, there is evidence that the plant causes extreme photosensitivity in animals that graze extensively on the plant. See Murray, supra note 47, at 17. Recently, however, the NIH have announced a $3.4 million clinical trial to study the effectiveness of St. John's Wort. See Joan O'Brien, Flower Power: Demand for St. John's Wort, a ‘Natural Prozac,’ Has Led to a Shortage, SALT LAKE TRIB., Dec. 4, 1997, at Bl.

134 See Lin, Jonathan H., Evaluating the Alternatives, 279 JAMA 706, 706 (1998)CrossRefGoogle Scholar.

135 Id. at 12. See generally King, supra note 40, at 6 (discussing an article and an editorial in the New England Journal of Medicine that illustrate the debate about whether new treatments are considered experimental or therapeutic).

136 21 C.F.R. §§ 310.500-546 (1997) (listing requirements for specific new drugs and devices). Alternative therapies are subject to FDA jurisdiction if they are considered to be drugs or nutritional therapies or are subject to labeling regulations as dietary supplements. See generally COHEN, supra note 110, at 73-79 (stating that the FDA has begun paying more attention to regulation in this area).

137 See 45 C.F.R. §§ 46.101-.409 (1997) (noting that the section applies to all research involving human subjects, conducted, supported by, or subject to regulation by any federal agency). See generally FAY A. ROZOVSKY, CONSENT TO TREATMENT 530-47 (1984) (discussing DHHS regulation of research involving minors).

138 See. e.g., In re Guess, 393 S.E.2d 833, 838, 840 (N.C. 1990) (upholding licensure revocation of physician who integrated homeopathy into his practice even though no patient was ever harmed); Sletten v. Briggs, 448 N.W.2d 607, 611 (N.D. 1989) (upholding licensure suspension of physician who persisted in using chelation therapy to treat arteriosclerosis, atherosclerosis, cardiac arrhythmia and hypertension, despite prior consent agreement to desist); Vance v. Fordham, 671 P.2d 124, 126, 131 (Utah 1983) (upholding revocation of physician's license for “unprofessional conduct” based on the agency's findings that Vance prescribed chelation therapy and laetrile, used kinesiology to test for food allergies and experimented with Kirlian photography as a diagnostic tool); Washington State Med. Disciplinary Bd. v. Johnston, 663 P.2d 457, 459, 461 (Wash. 1983) (upholding licensure revocation of physician who used “natural remedies” with two patients who subsequently died).

139 See, e.g., Rogers v. State Bd. of Med. Exam'rs, 371 So. 2d 1037, 1038 (Fla. Dist. Ct. App. 1979) (finding the State Board of Medical Examiners acted unreasonably in expelling a physician who offered chelation therapy and quashing its order of reprimand and probation), aff'd on other grounds, 387 So. 2d 937 (Fla. 1980).

140 See, e.g., Charell v. Gonzalez, 660 N.Y.S.2d 665, 666, 670 (Sup. Ct. 1997) (upholding negligence verdict against alternative practitioner who persuaded plaintiff to forgo chemotherapy in favor of special diet and coffee enemas). The potential for malpractice liability may not serve as much of a deterrent to offering nonvalidated or invalidated alternative therapies if the physician scrupulously adheres to informed consent requirements and the applicable state law allows assumption of the risk doctrine to act as a complete bar to causation. See, e.g., Boyle v. Revici, 961 F.2d 1060, 1063 (2d Cir. 1992) (finding that the issue of express assumption of risk, which bars recovery, should have been submitted to the jury). See generally Vincler & Nicol, supra note 32, at 166 (noting that the assumption of risk is a more appropriate analytical model than informed consent because complementary and alternative medicine therapies pose unknown risks).

141 Nancy King notes:

Not only is the “gold standard” of the [randomized control trial] disputed; it may even be outmoded. The promise of genetic medicine is turning us toward individually tailored treatments that are ill-suited to conventional evaluation through research. The stakes are high and getting higher in experimental treatment; “hard facts” about safety and efficacy are harder to come by as the standards for the introduction of new therapies change, changing researchers’ ability to collect data. Perhaps, then, it is time to address more systematically the role of the scientific method in medicine ….

King, supra note 40, at 12. See generally Benjamin Freedman et al., Placebo Orthodoxy in Clinical Research I: Empirical and Methodological Myths, 24 J.L. MED. & ETHICS 243, 250 (1996) (arguing that the practice of placebo-controlled trials in drug regulation is founded on false or misplaced beliefs and arguing for an alternative approach to the evaluation of new treatments); Benjamin Freedman et al., Placebo Orthodoxy in Clinical Research II: Ethical, Legal and Regulatory Myths, 24 J.L. MED. & ETHICS 252, 258 (1996) (critiquing regulatory and ethical myths underlying current use of placebos in assessing new medical interventions).

142 Warren, supra note 113, at 261. Larry Dossey, M.D., who edits Alternative Therapies, concurs:

While the double-blind method of evaluation may be applicable to certain alternative therapies … it is inappropriate for perhaps the majority of them. Many alternative interventions are unlike drugs and surgical procedures. Their action is affected by factors that cannot be specified, quantified, and controlled in double-blind designs. Everything that counts can not be counted. To subject alternative therapies to sterile, impersonal, double-blind conditions strips them of intrinsic qualities that are part of their power. New forms of evaluation will have to be developed if alternative therapies are to be fairly assessed.

Weber, supra note 1, at 21 (quoting Larry Dossey).

143 See Beyerstein, supra note 88, at 30.

144 See id. at 31.

145 See id. at 33.

146 Under the Hippocratic tradition, physicians have “an affirmative obligation to refuse to provide medical treatment when medicine cannot cure the disease or improve the patient's condition.” Levine, Eric, A New Predicament for Physicians: The Concept of Medical Futility, the Physician's Obligation to Render Inappropriate Treatment, and the Interplay of the Medical Standard of Care, 9 J.L. & HEALTH 69, 85 (1994)Google Scholar (citing PRESIDENT's COMM'N FOR THE STUDY OF ETHICAL PROBLEMS IN MED. & BIOMED. & BEHAVIORAL RESEARCH, DECIDING TO FORGO LIFESUSTAINING TREATMENT: A REPORT ON THE ETHICAL, MEDICAL, AND LEGAL ISSUES IN TREATMENT DECISIONS 44 (1983)). Physicians are not ethically required to offer futile treatments. See Smith, George P. II, Utility and the Principles of Medical Futility: Safeguarding Autonomy and the Prohibition Against Cruel and Unusual Punishment, 12 J. CONTEMP. HEALTH L. & POL'Y 1, 22 (1995)Google Scholar.

147 See generally Annas, George J. & Miller, Frances H., The Empire of Death: How Culture and Economics Affect Informed Consent in the U.S., the U.K., and Japan, 20 AM. J.L. & MED. 357 (1994)CrossRefGoogle Scholar (discussing the paradox between realizing the likelihood of death and the undeniable investing of large sums of money to postpone the inevitable).

148 Edmund Pellegrino, M.D., and David Thomasma, Ph.D., refer to the virtue required to resist patient desires in this instance as “fortitude.” See EDMUND D. PELLEGRINO & DAVID C. THOMASMA, THE VIRTUES IN MEDICAL PRACTICE 111 (1994). Fortitude is the virtue, the moral courage, to render an individual capable of acting on principle in the face of potentially harmful consequences without either retreating too soon from that principle or remaining steadfast to the point of absurdity. See id.

149 See id. at 75-77.

150 See id. at 127-33.

151 See generally Miles, Steven H., Informed Demand for “Non-Beneficial” Medical Treatment, 325 NEW ENG. J. MED. 512, 514 (1991)CrossRefGoogle Scholar (noting that a patient's entitlement to treatment can be more important than a patient's choice in using the entitlement, especially in cases where treatment is futile).

152 See Swanson, Jeffrey W. & McCrary, S. Van, Doing All They Can: Physicians Who Deny Medical Futility, 22 J.L. MED. & ETHICS 318,319 (1994)CrossRefGoogle Scholar.

153 See, e.g., Brett, Allan S. & McCullough, Laurence B., When Patients Request Specific Interventions, 315 NEW ENG. J. MED. 1347, 1347 (1986)CrossRefGoogle Scholar (arguing for a patient's right to demand futile treatment because, to the extent that patients have already gained access to the system, they are “entitled to a specific diagnosis or therapeutic measure of his or her choosing“); Tomlinson, Tom & Brody, Howard, Futility and the Ethics of Resuscitation, 264 JAMA 1276, 1276 (1990)CrossRefGoogle Scholar (arguing against a patient's right to demand futile treatment because physicians make certain value judgments as part of their reasonable medical practice); Veatch, Robert M. & Spicer, Carol M., Medically Futile Care: The Role of the Physician in Setting Limits, 18 AM. J.L. & MED. 15, 15 (1992)CrossRefGoogle Scholar (arguing for a patient's right to demand futile treatment because “decisions to limit access to care deemed futile should not rest with medical professionals“).

154 See, e.g., Youngner, Stuart, Who Defines Futility?, 260 JAMA 2094, 2094 (1988)CrossRefGoogle Scholar.

155 See E. Haavi Morreim, Profoundly Diminished Life: The Casualties of Coercion, HASTINGS CENTER REP., Jan.-Feb. 1994, at 33, 37 (noting that where physicians and patients have “drawn lines” in advance, there is considerably less likelihood of litigation).

156 See id. at 33.

157 Except when the patient will receive no physiologic benefit.

158 See Boozang, Kathleen M., Death Wish: Resuscitating Self-Determination for the Critically III, 35 ARIZ. L. REV. 23, 67-74 (1993)Google Scholar (discussing the line between medical judgment and patient values).

159 How to render treatment, observes Jay Katz, is a question for the physician; whether to undergo treatment is the patient's decision. See KATZ, JAY, THE SILENT WORLD OF DOCTOR AND PATIENT 98 (1984)Google Scholar.

160 Freedman et al., supra note 4, at 18; see also Miles, supra note 151, at 513 (patients may not demand that their physicians “provide plausible but inappropriate therapies (for example, amphetamines for weight reduction), or therapies that have no value (such as laetrile for cancer)“). 161 See generally Andrews, supra note 3, at 1298-317 (summarizing the regulation of alternative medicine).

162 See, e.g., Charell v. Gonzalez, 660 N.Y.S.2d 665, 667 (Sup. Ct. 1997) (offering nonconventional treatment (coffee enemas) by itself suggests a deviation from the standard of care which perhaps can only be solved by having the patient execute a comprehensive consent containing appropriate information as to the risks involved); Estrada v. Jaques, 321 S.E.2d 240, 254 (N.C. Ct. App. 1984) (patient not advised that embolization procedure was experimental and might not work); Shadrick v. Coker, No. 01S01-9705-CV-00100, 1998 Tenn. LEXIS 51, at *4 (Tenn. Feb. 17, 1998) (patient unaware until he learned from television news program that pedicle screw implants not approved by the FDA for spine).

163 See Estrada, 321 S.E.2d at 254 (finding that “[w]ith experimental procedures the ‘most frequent risks and hazards’ will remain unknown until the procedure becomes established“).

164 See OTA SUMMARY, supra 1, at 3; NCAHF Position Paper on Homeopathy, supra note 10.

165 See OTA SUMMARY, supra note 1, at 3.