American Journal of Law & Medicine

Western medicine opens the door to alternative medicine.(Law, Medicine and Socially Responsible Research)

I. INTRODUCTION

Physicians have struggled to defeat alternative medicine,(1) and to obtain a monopoly over the health care of their patients,(2) 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. Part V defends the conclusion that physicians should not offer unproven alternative therapies, but if certain circumstances exist to justify pursuing alternative treatments, physicians should adhere to the model of informed consent that governs the conduct of experimental clinical trials.

II. SHUTTING ALTERNATIVE MEDICINE OUT: A LOSING BATTLE

Organized medicine, since its inception, has fought to maintain a firm grip on the philosophy of health care generally, as well as on the specific treatments patients should have available to them. Lori Andrews succinctly captured this marshaling of power in her recent article about alternative providers:

In many instances, the barriers to the use of alternative

providers have been erected due to pressures from their main competitors,

physicians. Physicians convince legislatures to restrict the scopes of

practice of other providers and pressure prosecutors to bring criminal

actions against nonphysician providers. Physician groups have tried to

eliminate the practice of various alternative health care providers

including acupuncturists, chiropractors, homeopaths, midwives,

naprapaths, and naturopaths. In addition, since physicians are the main

breadwinners for hospitals, health maintenance organizations, and

other health care institutions, they exert a large amount of power over

the fashioning of policies to govern these institutions. Physician

groups have bullied hospitals into adopting policies that favor

physicians and disadvantage or even eliminate alternative health care

providers, even when there is no evidence that such policies are

necessary to protect patients.(3)

Despite centuries of physician dedication to eliminating alternative medicine and its practitioners, patients continue to be lured,(4) now as much as ever,(5) by unconventional therapies ranging from chiropractic, homeopathy, naturopathy and acupuncture to chelation therapy, light therapy and color therapy.(6) The various offerings of alternative medicine fall into one of three categories: (1) pure quackery (invalidated), (2) plausible but not yet proven (nonvalidated), or (3) proven to be efficacious (validated). This Article questions whether physicians should offer invalidated or nonvalidated treatments to their patients and concludes that they should not.

Some of America's most famous physicians (if the Best Sellers List serves as a reliable indicator)(7) have achieved notoriety by offering patients an appealing integration of the best that American medical expertise has to offer(8) with natural medicine. The popularity of these physicians signals the beginning of the end of orthodox medicine's dominance of health care in the United States. Even more remarkable, and perhaps the greatest evidence of alternative medicine's resilience, is managed care's increasing willingness to cover complementary health care practices.(9)

Patients show increasing reliance on alternative medicine and physicians show increasing openmindedness(10) about the therapeutic possibilities of some alternative treatments. Nevertheless, vociferous debate persists about the efficacy of much that alternative medicine has (or does not have) to offer.(11) Although some alternative therapies have been proven efficacious,(12) many promising alternative practices have been resoundingly rejected on scientific grounds.(13) Others have a plausible rationale but remain unproven.(14) The reaction to the renaissance of alternative medicine is so negative in some quarters that a number of organizations(15) and journals(16) have been established largely to discredit alternative therapies. In the last few years, Congress has entered the debate.(17) In 1992, Congress established the Office of Alternative Medicine (OAM) in the National Institutes of Health (NIH).(18) Current debate surrounds OAM's continued existence,(19) funding,(20) research grants,(21) and its general standing and power within NIH. The divisiveness over clinical testing of at least some alternative treatments is so acute(22) that some critics reject the notion that efficacy research is appropriate at all. Some critics say testing would waste scarce research dollars on notions that are scientifically indefensible.(23) Others, however, claim that natural therapies have stood the test of time and need not pass the rigors of scientific medicine,(24) or that testing is impossible because of the unique nature of some forms of alternative medicine.(25)

Some laypersons and policy-makers find it impossible to sort through the charges and countercharges between proponents of orthodox and alternative medicine. The medical profession's objections to alternative medicine are made against a backdrop of its own failures. These include a failure to test properly new treatments and procedures before use in the clinical setting,(26) and a history of overzealous and self-interested control of health care (frequently to the detriment of cost containment and quality care).(27) Interference with innovative practices that could benefit patients and improve care is not good public policy. Abusive criticisms of alternative practitioners and threats to their licensure solely because they offer their patients an integrated practice are similarly ill-advised.(28) On the other hand, quacks and frauds unquestionably abound. If consumer protection means anything, it should protect people weakened by illness from the dangers attendant to unsound health practices.(29)

Even as these battles about alternative medicine rage unabated, physicians are gradually succumbing to external pressures to integrate alternative techniques and conventional medicine.(30) These pressures come from a variety of sources, including physicians' opportunistic desires,(31) managed care interests(32) and, most frequently, patient demands.(33) Physicians' acquiescence to these pressures is problematic on a number of levels. First, few physicians receive training in alternative medicine techniques.(34) Even when alternative therapies offer proven therapeutic benefit, conventionally trained physicians may not be competent to realize such benefits or to co-manage a patient's care with an alternative provider.(35) The problem of conventional physicians' competency to administer alternative medicine is not addressed in this Article but presumably can be addressed through hospital and managed care credentialing processes, professional organizations or the malpractice system.(36) This Article focuses on the use of alternative alternative techniques by physicians(37) for the treatment of nonterminal patients in purely clinical (nonresearch) settings.(38) The issue is whether physicians may offer treatments (either alone or jointly with an alternative practitioner) that are nonvalidated,(39) or that are quack remedies. As used here, "nonvalidated" treatments refer to interventions that may have a basis in scientific theory for use in medical care but that are otherwise unproven, innovative and/or experimental. "Quack remedies" refer to interventions that are "invalidated" because they have neither a proven nor any scientific basis for any health benefit. I use the terms unproven, nonvalidated or innovative to refer to the methods(40) described in my first category,(41) and the terms invalidated or quackery to encompass the second category.

This Article does not contemplate the physician-researcher who is engaged in either pure experimentation or a combination of treatment and research.(42) Similarly, it does not focus on the patient who is terminally ill,(43) and for whom no conventional curative option exists.(44) This Article is mainly concerned with whether it is proper for physicians to offer, agree to manage jointly or to accede to patient demands for alternative therapies that may not be particularly harmful,(45) but for which little or no proof of potential benefit exists. This Article concludes that physicians should never accede to patient demands for invalidated treatments. This prohibition should extend to nonvalidated treatments under two conditions: (1) if no or little evidence exists to suggest that treatment will be beneficial or (2) if some evidence suggests that treatment might be beneficial but, in the physician's judgment, the treatment is unlikely to do any good. However, this Article concludes that physicians may accede to patient demands for nonvalidated treatments under the following narrow conditions: if extant research results are very promising, if the physician believes that a particular patient may benefit, if the risk of harm is very low, and if the physician adheres to the conventions that govern the doctrine of informed consent for experimental treatment.

III. THE PRESSURE TO PROVIDE ALTERNATIVE THERAPIES

A. THE CONFUSION OF DEFINITIONS

The most recent alternative medicine resurgence largely results from a generational pursuit of independence and nonconformity. Paradoxically, as some alternative therapies have successfully undergone double-blind clinical trials (the "gold standard")(46) and have been proven to be efficacious,(47) physicians who offer them are shedding the "alternative" label, in hopes that the therapy will gain the respectability of orthodox medicine. Consequently, confusion abounds as to what currently comprises alternative medicine. The following summary attempts to identify those alternatives most generally associated with the term.

1. Homeopathy

Americans spent $165 million on homeopathic remedies in 1994 and sales since then have been increasing about twenty percent per year.(48) First introduced by a German physician, Samuel Hahnemann, in about 1796,(49) homeopathy relies on the "law of similars," which suggests that natural substances that produce certain symptoms in healthy individuals cure those same symptoms when they appear in someone who is sick.(50) Homeopathy also teaches that "life is a spiritual force (vitalism) which directs the body's healing," a process which can be stimulated with the smallest amounts of natural substances,(51) Consequently, homeopathy begins with natural substances(52) which are then subjected to a process of "succussion" or shaking, which dilutes the substance to eliminate the deleterious or toxic side-effects of the substances being used without reducing its effectiveness,(53) The "Law of Infinitesimals holds that the smaller the dose of a medication, the more powerful will be its health effects."(54) As such, homeopathic solutions are frequently diluted to the point where not even a single molecule of the active substance remains,(55) in the belief that the alcohol or water substance "remembers" the original substance,(56) due to some "spirit-like vital principle."(57) Although a paper published in 1988 (popularly referred to as the "Benveniste" paper) supports this hypothesis,(58) no subsequent study has successfully duplicated the touted results and the theory is widely rejected outside of homeopathic circles.(59) Beyond the dispute over the plausibility of the underlying theories of homeopathy,(60) the hundred-plus controlled clinical trials of homeopathy concluded that there was no acceptable evidence that it is effective.(61)

2. Chiropractic

Chiropractic epitomizes the recent history of alternative medicine because, although chiropractic may represent the most utilized alternative therapy in the United States,(62) organized medicine has spared no expense or energy in attempting to eliminate it.(63) Given this history, it is even more astounding that increasing numbers of physicians refer patients to chiropractors or themselves engage in "manipulative therapy."(64) Having successfully used the courts to quash physician opposition to their existence,(65) chiropractors number about 45,000 in the United States(66) and have licensing boards in every state.(67)

Despite this apparent assimilation into mainstream health care, as well as substantial scientific evidence that manipulative therapy can be employed successfully to relieve back pain,(68) chiropractic remains controversial. First, some amount of discomfort remains regarding the underlying theory of chiropractic, which is based on its founder's theory that ninety-five percent of diseases are caused by displaced vertebrae.(69) Second, chiropractors resist any attempts to limit their practice to back care, applying their therapies to other ailments for which scientific support remains insufficient,(70) leading to complaints by physicians that chiropractors manipulate spines inappropriately(71)and misuse X-rays.(72)

Finally, it has been suggested that chiropractic practice is extremely variable,(73) with some practitioners increasingly mixing their treatment techniques with several other alternative therapies.(74)

3. Acupuncture

Acupuncture adherents believe that "illness is caused by a disruption in the flow of qi (pronounced "chee"), the collection of energies that endow us with our vitality."(75) Therapy involves the insertion of needles at certain points in the skin to activate qi.(76) Acupuncture is used in the United States primarily for pain relief,(77) although it is also suggested for "rheumatoid and osteoarthritis, muscle and nerve `difficulties,' depression, smoking, eating disorders, drug `behavior problems,' migraine, acne, cancer, and constipation."(78) One of the most obvious problems in subjecting acupuncture to traditional clinical scrutiny is the difficulty in achieving double-blind trials.(79) According to one recent article:

Two meta-analyses of acupuncture for pain relief indicate that the

best-controlled studies show no difference in effectiveness between

genuine acupuncture and control or sham procedures, whereas the

worst-controlled studies show the greatest effectiveness.

Acupuncture acts on pain probably through a combination of

counterirritation and misdirection of pain, consensual expectation,

and classical conditioning and reinforcement. Other factors that

play a role may be political belief, disaffection, and economic

interest. Endorphin secretion may add to the temporary euphoria for

conditioning, but probably has little to do with overall success.

The needles themselves are not necessary for pain relief.(80)

4. Additional Therapies

Alternative therapies include a host of other methods including aroma therapy, art therapy, biofeedback, bodywork/manual therapy, botanicals/herbs, environmental medicine, hyperbaric oxygen therapy, herb therapy,(81) hypnosis, light therapy, magnetic stimulation, mind/body medicine, music therapy, nutrition,(82) traditional Chinese medicine, yoga and supplements,(83) Visualization (imagery) combined with psychotherapy has been tested as a possible cure for cancer.(84) Other therapies listed on the OAM web page include anthroposophy, color therapy, eclecticism, electrical stimulation therapy, applied kinesiology, massages, moxibustion, organotherapy, radiesthesis, reflexotherapy, relaxation techniques, therapeutic touch, and tissue therapy.(85) A renewed focus on spiritualism and healing has inspired interest in "Siberian shamanism, near-death experiences, Native American healing, Tibetan Buddhist spirituality, Indian Ayurvedic medicine, homeopathy, nutrition, contacts with extra-terrestrials, creativity, brain longevity, trance-channeling, indigenous healing and astrology."(86)

Patients encounter numerous alternative treatment offerings, which basically fall into four categories: "spiritual and psychological; nutritional; drug and biologic; and physical forces and devices."(87) Whatever their nature, physicians are bound to aid their patients in sorting through their various promises of cure and relief, to see which truly have something to offer.

B. THE SURGE IN PATIENT DEMAND FOR ALTERNATIVE THERAPIES

The resurgence of alternative medicine stems from a number of phenomena. Some attribute renewed consumer interest of the 1960s and 1970s to alternative medicine's reliance on natural remedies and spirituality, which appealed to the anti-establishment, antitechnology, and counterculture tendencies of the times.(88) Alternative medicine practitioners are also known for the greater attention they give to their patients at a time when medical doctors are increasingly criticized for their lack of compassion and personal interaction in their provision of care.(89) Thus, to a great extent, it seems that patients seek out alternative practitioners for the humaneness that conventional care wants. Medicine remains substantially a white male profession, frequently inattentive or unresponsive to the needs and values of women, nonwhites, and those of lower socioeconomic classes. …

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