Voluntary Self-Regulation of Complementary and Alternative Medicine Practitioners

Beginning of article

"The urge to regulate is stronger than the sex drive." (1)

I. INTRODUCTION

Complementary and alternative medicine (CAM) has been practiced and used in this country continuously since the nineteenth century. (2) All of the forms of care present then are still present today including botanical medicine ("Thomsonians"), health food ("Grahamites"), homeopathy, hydrotherapy, healing touch ("mesmerists"), osteopathy, naturopathy, chiropracty, and Christian Science. (3) In the 1920s and early 1930s, three studies reported CAM usage of thirty-four percent, eighty-seven percent, and ten percent. (4) Thirty percent of those born before 1945 use CAM compared with about one-half of those born between 1945 and 1964 and seventy percent of those born between 1965 and 1979. (5) Although there may have been a period of diminished use of CAM in the 1930s and 1940s, there has been a continual increase in usage since the 1960s. (6)

There are academic and social definitions of CAM, (7) but in this Article I use a legal definition. A Minnesota statute states:

   "Complementary and alternative health care practices"
   means the broad domain of complementary and alternative
   healing methods and treatments, including but not limited
   to: (1) acupressure; (2) anthroposophy; (3) aroma therapy; (4)
   ayurveda; (5) cranial sacral therapy; (6) culturally traditional
   healing practices; (7) detoxification practices and therapies;
   (8) energetic healing; (9) polarity therapy; (10) folk practices;
   (11) healing practices utilizing food, food supplements,
   nutrients, and the physical forces of heat, cold, water, touch,
   and light; (12) Gerson therapy and colostrum therapy; (13)
   healing touch; (14) herbology or herbalism; (15) homeopathy;
   (16) nondiagnostic iridology; (17) body work, massage, and
   massage therapy; (18) meditation; (19) mind-body healing
   practices; (20) naturopathy; (21) noninvasive
   instrumentalities; and (22) traditional Oriental practices,
   such as Qi Gong energy healing. (8)

Similar detailed language is also used in a Rhode Island statute, (9) but California adopted a more general approach, defining it in the negative. (10) The statute refers to legislative findings that

   complementary and alternative health care practitioners ...
   are not providing services that require medical training and
   credentials.... [and further] that these nonmedical
   complementary and alternative services do not pose a known
   risk to the health and safety of California residents, and that
   restricting access to those services due to technical violations
   of the Medical Practice Act is not warranted. (11)

The statute itself is an exemption from the Medical Practices Act for persons who provide a statutorily defined disclosure statement and who do not perform any of a short list of controlled acts. (12) The legal definition of CAM therefore includes both a general component based on safety--the fundamental policy justification for all public health regulation--as well as a non-exclusive list of specific, safe, unregulated health care modalities that are more or less found widely in contemporary American society.

Next to allopathy, (13) homeopathy was once the most well-known and successful school of medicine until the allopaths consolidated regulatory control over the practice and professions of medicine in the first two decades of the twentieth century and used it to eradicate as much of the competition as they could. (14) "In 1898, homeopaths had 9 national societies, 33 state societies, 85 local societies and 39 other local organizations, 66 general homeopathic hospitals, 74 specialty homeopathic hospitals, 57 homeopathic dispensaries, 20 homeopathic medical colleges, and 31 homeopathic medical journals," (15) and in 1902, there were 15,000 practitioners. (16) By 1980 there were 128 homeopaths and no homeopathic hospitals. (17)

I use homeopathy to illustrate how existing regulation of health care providers works for both licensed and unlicensed CAM providers. The effect of allopathic control of laws regulating the practice of medicine has resulted in a patchwork of restrictive or ambiguous laws that cover CAM providers that vary from state to state. (18) The regulatory climate combines with the low number of practitioners to make legislative changes difficult; however, without regulatory changes it is hard for communities of practitioners--especially homeopaths--to grow. In this Article, I recommend that homeopaths and other similarly situated practitioner groups organize on a state-by-state basis around a code of conduct as a means to counteract divisive and restrictive laws as well as internal disputes to achieve solidarity.

In Parts I and II, this Article describes homeopathy and the regulatory environment in which it finds itself. The authority of the state to regulate health care providers is part of its police power to protect the public health. Accordingly, Part III addresses the concept of safety and related concepts in the provision of health care. This Article then briefly identifies different approaches to the regulation of occupations, and then looks specifically at existing regulation of health care professionals. First, this Article examines the monopoly the conventional medical profession holds, as it is one of the primary impediments to the growth of other health professions. Then, this Article examines a constitutional argument against exclusive, universal scope of practice statutes. In Part IV, the response of the Health Freedom Movement (19) to the existing regulatory scheme for health care professionals is discussed. In Part V, this Article discusses options for the community of practitioners of homeopathy. This Article then concludes by stating that voluntary self-regulation around a code of conduct is the most viable alternative for homeopathy--and other unregulated CAM modalities--in the context of an exemption from the medical practice acts that is contingent on a disclosure statement to compensate for informational asymmetries in the health care market.

Parts III and IV of this Article also provide a framework for looking at how information is related to safety: the basis for regulation of health care providers. If the modalities themselves are safe, then the only danger is informational. This Article applies ethical principles to a safety analysis in both the social order (medicine and law) and the economic order, concluding reform of scope of practice laws would be best for collective and individual good and suggesting that the principles developed in the paper for analyzing safety issues can be applied more widely in analyses of allocation of resource problems in the health care system.

Annex A is a model code setting up a voluntary self-regulation scheme for CAM practitioners that is intended not only to legitimate CAM practitioners, but to foster integration of CAM practitioners into the existing health care infrastructure.

II. ABOUT HOMEOPATHY

Homeopathy is a school of medicine (20) now referred to as a "whole medical system[]" by the National Institutes of Health Center for Complementary and Alternative Medicine. (21) It is a "complete system of medical theory and practice" (22) that was more or less fully developed prior to the theory and practices of allopathic medicine. (23) Homeopathy has also been characterized as a professionalized health care system with its own theory of health and disease, schools and standardized curricula to teach its concepts, delivery system of a network of practitioners, United States Food and Drug Administration (FDA) federally regulated medicines and pharmacies, regulations in several states, social and professional structures and expectations, and national certification and school accreditation functions. (24) It has grown several hundred percent in recent years. (25)

The distinction between homeopathy and other CAM modalities is important. Homeopathy, like traditional Chinese medicine and Ayurveda, is a complete system of medicine. In this sense it is unlike reiki and other techniques and methods referred to in the Minnesota statute. (26) It is a drug-based system with extensive literature that is predominantly practiced by physicians licensed in conventional medicine. A shortcoming of the legal definition of CAM is that its measure of demarcation--from allopathic medicine--is safety. This is correct and serves the general public health purpose but it does not recognize either the public health enhancements that come from collectives of practitioners--such as continuing education and a code of conduct--nor does it recognize that homeopathy is not a technique that can be learned in a short period of time. To be sure, some acute prescribing can be learned easily, but it takes years of technical training and practice to acquire the skills necessary to utilize the full scope of its power in all types of disease, especially chronic diseases.

Homeopathy was developed by Samuel Hahnemann, M.D. (1755-1843) over a period of about fifty years. (27) In 1790, having become discouraged with the often violent and dangerous medical practices of his time, Hahnemann was translating a work of the eminent Edinburgh physician William Cullen from English to German. (28) Cullen addressed the medicinal power of Cinchona bark--also known as Cortex Peruvianus--to cure malaria over the space of some twenty pages and concluded its effect was due to it being a stomach tonic by stating, "I have endeavoured [sic] to explain, in my first outlines of practical medical science, that the bark in this instance acts through its tonic effect on the stomach, and I have found nothing in any writings which could make me doubt the truth of my statements." (29)

Hahnemann attacked this line of thinking vigorously and in the ensuing empirical activity he discovered the principles of homeopathy:

   By combining the strongest bitters and the strongest
   astringents we can obtain a compound which, in small doses,
   possesses much more of both these properties [stomach tonic]
   than the bark, and yet in all Eternity no fever specific can be
   made from such a compound. The author should have
   accounted for this. This undiscovered principle of the effect of
   the bark is probably not very easy to find. Let us consider
   the following : Substances which produce some kind of fever
   (very strong coffee, pepper, arnica, ignatia-bean, arsenic)
   counteract these types of intermittent fever. I took, for
   several days, as an experiment, four drams of good china
   twice daily. My feet and finger tips, etc., at first became cold;
   I became languid and drowsy; then my heart began to
   palpitate; my pulse became hard and quick; an intolerable
   anxiety and trembling (but without a rigor); prostration in
   all the limbs; then pulsation in the head, redness of the
   cheeks, thirst; briefly, all the symptoms usually associated
   with intermittent fever appeared in succession, yet without
   the actual rigor. To sum up: all those symptoms which to me
   are typical of intermittent fever, as the stupefaction of the
   senses, a kind of rigidity of all joints, but above all the numb,
   disagreeable sensation which seems to have its seat in the
   periosteum over all the bones of the body--all made their
   appearance. This paroxysm lasted from two to three hours
   every time, and recurred when I repeated the dose and not
   otherwise. I discontinued the medicine and I was once more
   in good health. (30)

Hahnemann then reasoned--using inference to the best explanation--that since Cinchona bark caused symptoms that matched and cured intermittent fever, the medicinal effect of a medicine could be measured by the symptoms it caused in a healthy person. (31)

Homeopathy revolves around three principles. The first principle is that the medicinal effect of a substance can be measured by giving the substance to a healthy human. (32) The process of giving substances and recording the symptoms caused by the substance is known as "provings" or "human pathogenic trial." (33) After administration of the substance, the symptoms are recorded and indexed both by drug and symptom. (34)

The second principle has two components: first, disease is known by assessing the signs and symptoms presented by the patient; second, generally speaking, all of the symptoms and signs a person presents with are caused by one disease. (35)

The third principle is the "law of similars," similia similibus curentur, or "let likes be cured by likes." (36) The patient is carefully evaluated and all of the signs and symptoms of the disease are noted down. (37) The homeopath then consults with the symptom indexes (repertories) to compare the signs and symptoms of the natural disease with the signs and symptoms of the remedies (the artificial disease), narrowing down the matches to a few remedies. (38) For these remedies, the homeopath studies the drug indexes and finally selects the remedy whose medicinal effect most closely matches that of the disease. (39) Once given, the remedial disease annihilates the natural disease in the vital sphere, and since the disease and the symptoms are the same, the symptoms disappear. (40)

Interestingly, no technology is used to evaluate the patient or drugs. Rather, the patient--or prover--elucidates the symptoms under the careful questioning of the homeopath and the signs of the disease are discerned by the patient, other observers, and the homeopath. (41)

In 1796, Hahnemann published his first article describing the homeopathic system. (42) That article had two parts. In the first part, Hahnemann described the system; in the second part, he described the symptoms of fifty-nine substances, all but a few being plants. (43) The first part would be rewritten once before becoming the manual of homeopathy--Oragon der Heilkunst, translated as Organon of Medicine or Organon of the Medical Art--which was to undergo five major revisions. (44) The second part would become the first Materia Medica or Materia Medica Pura. (45) The Organon and the Materia Medica Pura are still in use today.

By the end of the eighteenth century, Hahnemann began to address the problem that the drugs he was using not only cured the disease, but often caused additional symptoms. (46) He began to dilute the drugs and observed that their medicinal effect remained, but they no longer caused unwanted additional symptoms. (47) Thus began the use of dilutions and ultimately ultradilutions.

Between 1815 and 1820, Hahnemann developed the system of succussing--vigorously agitating the solutions between dilutions-further developing the medicinal effect of the drug. (48) A substance that has been diluted and succussed according to the detailed instructions in the ORGANON is known as a homeopathic remedy, although any substance diluted or not can be used homeopathically or--according to the law of similars--to treat disease. (49) Hahnemann himself proved over one hundred substances, all of which are routinely used in homeopathic practice today. (50)

III. HOMEOPATHY IN THE UNITED STATES TODAY

Homeopathy was introduced to the United States in 1825. (51) It quickly took hold and flourished by the late nineteenth century. (52) In 1902, there were some 15,000 practitioners. (53) By 1963, the number had dwindled to 1,477, and by 1980 there were only 128 practitioners. (54) Prior to the 1980s, all homeopaths were conventional doctors, (55) but in the 1980s, after much discussion in the physician dominated community, lay students were accepted by the teachers. (56) They began educating other lay practitioners, and by the end of the 1980s there were enough trained unlicensed homeopaths to start their own national organization. (57) Unfortunately, the unlicensed homeopaths and the allopathically trained homeopaths did not see eye to eye. The unlicensed homeopaths accused the homeopathic allopathically trained doctors of being ill-trained in homeopathy, and the medical doctors saw their unlicensed brethren as being naive and incompetent about medical science. (58) This rift has substantially healed. (59) Although the exact numbers are unknown, there are probably between 500 and 600 homeopaths practicing in the United States today; the 259 certified and 128 conventionally trained medical doctor homeopaths can be found in 35 states. (60)

In 1982, a group of homeopaths, at that time medical doctors and lay members of the community, formed the Council for Homeopathic Education (CHE) to standardize homeopathic education and accredit schools, (61) but the organization accomplished little. The lay practitioners from England brought with them a new educational model, and by the late 1990s there were enough schools of homeopathy in the United States--approximately twenty-five (62)--to call for a renewed effort at accreditation and standardization of a curriculum. (63) In 2000, CHE sponsored a series of meetings to which educators and the leadership of the community were invited. (64) The meetings resulted in a standardized curriculum based on those used in Europe, which has a much longer history of an active homeopathic community. (65) However, efforts to operationalize the curriculum and seek status as an accrediting agency from the Department of Education for the CHE have been met by the CHE board of directors with such fear of government intervention and antagonism by proponents of market regulation, that the CHE remains a powerless institution in the community. Only three schools have adopted or are attempting to adopt the curriculum and CHE standards for accreditation. (66)

In 1991, a year after the unlicensed homeopaths organized, a group of licensed and unlicensed practitioners formed the Council for Homeopathic Certification (CHC). (67) At that time there were certifications of competence in homeopathy available for medical doctors, (68) naturopaths, (69) and unlicensed practitioners through the North American Society of Homeopaths (NASH), (70) but there was no community-wide standard and the existing certifications were seen as being weak. The CHC has become a model of a successful organization in the homeopathic community, respected by most, and its certification is highly regarded by all. Sitting for the CHC exam requires 500 classroom hours of training, including human health sciences and knowledge of approximately 200 homeopathic drugs. (71) In order to be certified, one must pass the exam, pass another case analysis exam, and present five well-documented cured cases of chronic disease. (72)

The Federal Food, Drug, and Cosmetic Act defines drugs to include homeopathic remedies and regulates their manufacture and labeling through the Homeopathic Pharmacopoeia of the United States (HPUS). (73) There are 1,286 drugs recognized in the HPUS, all but 39 of which are classified as "over-the-counter." (74) Although homeopathic practitioners use tinctures, most prescribe substances that have been serially diluted and succussed far beyond the point at which Avogadro's number would indicate that there are no molecules of the original substance left. (75) This is perhaps the most troublesome aspect of homeopathy for scientists and others.

Nonetheless, the most commonly used 100 remedies have been in continuous use around the world for more than 150 years, and a majority of the most commonly used 300 remedies have been widely used for more than 100 years. As a result of the dilution they are non-toxic.

Homeopathy is practiced in the United States by a great diversity of health care practitioners. (76) Conventional medical doctors (MDs), osteopaths, chiropractors, naturopaths (NDs), physicians' assistants, nurse practitioners (NPs), nurses, veterinarians, licensed acupuncturists, massage therapists, and other licensed health care practitioners, and those without any kind of license, use homeopathy as their practice or as an adjunct to their practice. (77)

Twenty-seven states have current laws specifically regarding homeopathy, excluding those states that incorporate the homeopathic pharmacopoeia into their food and drug laws. Fourteen states, (78) plus the District of Columbia, Puerto Rico, and the Virgin Islands, license naturopathic doctors and include homeopathy in their scope of practice. (79) Connecticut, Arizona, and Nevada license medical doctors to practice homeopathy, (80) and Arizona and Nevada specifically authorize homeopathic assistants to practice under the supervision of a homeopathic physician. (81) Texas, Illinois, and Maine include homeopathy in veterinary practice. (82) Iowa law authorizes a "department of homeopathic materia medica and therapeutics in the college of medicine of the state University of Iowa," (83) and Michigan law authorizes a homeopathic medical college (84) and requires at least one professor of homeopathy to be employed in the University of Michigan Department of Medicine. (85) At least seventeen states have laws or regulations defining the standard of care for conventional physicians in relation to CAM modalities. (86) One such state, Florida, protects all licensed health care providers who practice CAM. (87)

Homeopathy is used in about 3.6 percent of visits to CAM practitioners. (88) CAM users primarily seek "treatment of health problems that lack definitive cures; that have an unpredictable course and prognosis; and that are associated with substantial pain, discomfort, or side effects from prescription drug medicine." (89) In other words, they seek treatment primarily for chronic diseases. (90) Although estimates for the cost of treating chronic disease are as high as 78 percent of all health care costs, and some 130 million Americans report having a chronic disease, about 75 percent of Americans feel it is difficult to get adequate care for a chronic condition from either a primary care physician or a specialist--an opinion shared by over half of all physicians and a majority of policy-makers. (91) It is obvious that CAM, including homeopathy, will only continue to grow in social and economic importance. (92)

IV. REGULATING HEALTH CARE PROVIDERS

Regulation of the health care occupations can be described in the legal, economic, social or moral, and political orders. Recognition of the different contexts in which analyses occur is important, as the terms of analysis determine the norms used and recommended outcomes. Projected or desired outcomes in different orders might conflict. (93) For example, while the use of economic analysis in the legal order has been an important element of regulatory analysis since the 1970s, economic analysis can be unrevealing, if not anemic, with regard to norms of the social or moral order. (94)

In accord with the philosophically libertarian health freedom movement, (95) Part III of this Article argues for exemptions from the medical practice acts for CAM providers; however, this Article disagrees with the movement and concludes that organizing providers into communities around a code of conduct is beneficial not only for the profession, but for society as well. Communities of practitioners need not devolve into economically-driven lobbying organizations such as the American Medical Association, but can function for the social or moral purpose of maintaining ethical and practice standards and a complaint procedure.

A. Justifying Regulation

The State has the obligation and legal power to regulate occupations to ensure public safety. (96) The more potentially dangerous the occupation is to the person seeking health care, the greater the need for regulations

There are two kinds of danger in health care. First, "instrumental danger" arises from the danger of the practice itself. For example, traditional medical procedures, such as surgery and the use of ionizing radiation, are inherently dangerous. The State has a very strong interest in ensuring that surgeons and radiation specialists have minimum competence and are subject to defined oversight. On the other hand, the instruments of complementary and alternative medicine modalities have no inherent danger. (98) Various states have made lists, which I will discuss below, of controlled or prohibited acts that define the content of instrumental danger. Violations of norms deriving from instrumental danger give rise to batteries and malpractice cases. (99)

The second kind of danger is indirect, arising from a potential information asymmetry. I refer to it as "informational danger." Violations of norms protecting against informational danger give rise to lawsuits centered on breach of contract, breach of fiduciary duty, and violation of informed consent rights; when the patient is seen as an autonomous decision-maker, he or she may be centered on the idea that the person receiving the services was unable to properly evaluate the risk of his or her condition or the recommended therapy. (100)

The informational environment has three elements: the person seeking services, the information needed to remain autonomous when seeking or getting health care, and the provider. (101) Discussing the informational environment of health care is complex because the context or order within which the discussion occurs must be defined. (102) Information can be spoken of in the economic order, legal order, social or moral order, or the political order. For example, three words are often used to describe the person who seeks health care--the first element of the informational environment.

The word "patient" has primarily social or moral meaning. It refers to a person who is seeking health care and makes strong reference to the paternalistic authority of the physician and the passivity of the person seeking health care. (103) It encompasses the entire spectrum of vulnerability, clearly including persons who are incompetent to make health care decisions about their own care, whether by accident, chronic disease, or the roulette of birth. (104) It is a fiduciary relationship, invoking the highest legal duty owed by one person, the professional, to another, the patient.

The word "client" has different connotations. It references the legal order and the power differential based on information between the physician and the person seeking health care. (105) Clients depend on professionals to guide them in making decisions concerning matters on which the professional has special training and experience. A client has the full panoply of constitutional protection for his or her fundamental right to self-determination--to bodily-integrity and autonomy--whereas the state may have an interest in the patient. (106)

Lastly, the word consumer or "customer" references the economic order. It refers to autonomous beings who make choices in the market place based upon information. (107) To the extent that there are information asymmetries, market interventions are needed to correct the asymmetry and restore the efficiency of optimal autonomy. The words consumer, "client," or "patient" can be used in the political order--depending on the intention of the speaker--as politics encompass the moral or social, legal, and economic orders.

Word choice is useful in discussing the regulation of CAM, as it provides a reminder of who is being regulated and for what reason. I use the words as follows: a "patient" is a person suffering to the extent that most people would not be able to think clearly; (108) he or she is dependent on the health care provider for his or her well-being and perhaps very existence. It describes the most vulnerable people who seek health care. A "client" is suffering from milder conditions or chronic conditions which are not life-threatening flare-ups or for which he or she has compensated for. A client has conditions that make them feel vulnerable, but he or she is not intrinsically dependent on the provider. A "consumer" could also be suffering from a mild condition, could be seeking enhancement, or could be the surrogate decision maker for an incompetent. In any event, a consumer has no feelings of dependency and is not seeking a dependent relationship. Clients and consumers can be thought of as having the ability to make independent, informed, and autonomous choices about health care, whereas patients may or may not. (109) I will use the word consumer generically to refer to the person seeking health care without regard to context.

The second element of the informational environment is the informational content consumers need in order to sustain their autonomy by being able to properly evaluate the risks and benefits of a particular health care decision. (110) This information is diagnosis or evaluation, prognosis, and information about treatment options. (111) Until the 1960s, the primary source for this information was the conventional doctor. (112) This binary informational structure supported the customer as the patient because the patient was dependent on the physician for all information. (113) Today, the only category of content that is unavailable to the consumer directly is the technical information related to their diagnostic procedures and tests, although even this is changing as MRIs, drugs, and other technology are marketed directly to consumers. Once a consumer has a diagnosis and test results, he or she has access to the same information on prognosis and treatment options as the physician. In fact, often the consumer has access to more information than the physician, as he or she has more time, is more interested in the outcome, and is more willing in many cases to try alternatives that the physician either knows little to nothing of or is negative about, such as CAM. (114) It can be argued that the physician has the experience that gives him or her an advantage in evaluating prognosis and treatment; however, this argument is weak both practically and theoretically. Few specialists have experience in all forms of treatment. They rely on writings from the professional press to inform themselves of alternatives, which is not the same thing as direct experience. Furthermore, the trend of "evidence-based" thinking undercuts the authority of professional experience.

The third element of the informational environment is the providers. As experts, they are to provide a diagnosis or evaluation and prognosis, recommend a course of action, provide information about the recommended treatment, and recommend the best provider of the treatment. (115) They are also obligated to provide information about the limits of their own capability to deliver treatment. Information from the provider can be judged in the legal, social or moral, economic, and political orders. In the legal order, about one-half of the states require the provider to give information that is relevant to the consumer (patient-oriented standard), and about one-half allow the doctor to provide information that is relevant in the doctor's opinion (doctor-oriented standard). (116)

Conventional physicians have a legal monopoly on the practice of medicine. In the social or moral order, the conventional physicians have a culture of paternalism, although this is changing as autonomy increases and physician authority is eroded by institutional and corporate medicine. In the economic order, the physician-oriented standard can never be efficient or optimal as it institutionalizes an informational asymmetry. Conventional physicians, because of the inequality of their superior position vis-a-vis the consumer, should bear the risk of information inefficiencies especially since there is data that suggests they have little interest in providing relevant information as a group to persons seeking health care. (117)

Efficacy and safety are often conflated as though they are one standard for measuring a therapeutic intervention; in fact, they are very different standards. In the standard formulation, safety refers only to instrumental safety and not to informational safety. Efficacy, on the other hand, is an informational standard: an artificial construct that seems to have more rhetorical value than anything else. (118) Randomized controlled trials are used to evaluate this measure, but theoretical analysis, (119) historical events, (120) and recent events (121) all suggest that the idea that one or more randomized controlled trials can provide accurate information on an intervention is at least greatly suspect.

The conventional medical profession insists that competent adults cannot make informed decisions about CAM because only the conventional medical profession can adequately evaluate the safety and efficacy of CAM modalities. (122) In addition, every CAM modality for every disease has not been evaluated. (123) The only valid information about CAM is what the conventional medical professionals say they have created through randomized controlled trials. (124) There is no evidence that the assumptions made by the conventional medical profession--with regard to information on the efficacy of CAM--have any validity whatsoever. (125) On close inspection, the misrepresentations and gaming that the conventional medical profession does with information about efficacy is another aspect of their attempt to maintain the informational asymmetry for economic ends. (126) Because CAM modalities are generally instrumentally safe, the only potential safety problem with efficacy is in emergencies, and training in proper recognition and response to emergencies should suffice to overcome the danger.

The regulation of instrumentally dangerous modalities is clearly justified on safety grounds; however, it is not clear that any regulation but required disclosure is necessary to protect public health from informational danger. Customers and clients are not vulnerable enough to worry about, but there are patients who are very vulnerable. Do they need special regulations to protect them?

Putting aside intentional fraud, (127) which is covered by civil and criminal fraud laws, threats to the public health arise from information asymmetries in a life-threatening emergency when the provider is incompetent to recognize or treat that particular condition. Requiring training and certification in the recognition of emergencies would solve this problem.

B. Describing Regulation

Commentators on licensing and other regulatory schemes regarding the professions tend to fall into three camps. One camp approaches its analysis as though the government--sua sponte--licenses professions for public health reasons. (128) The opposing camp approaches the analysis as though regulation of professionals--for example, the passage of specific occupation related laws--occurs at the behest of the regulated profession. (129) A third camp takes the intermediate approach that government and the professions negotiate for a regulatory scheme that meets both the needs of the state and the profession. (130) The latter two approaches appear to be supported by the scope of licensing. In 1983, there were nearly 1,000 occupations regulated in the fifty states. (131)

There are three theories or models of regulation of medical occupations: the market model, the professionalism model, and the hierarchical command and control--or bureaucratic--model. (132) The distinctions and arguments between the three models have their origin in the early nineteenth century debate between the Federalists, who argued that a governmental presence was needed to guarantee property rights, enforce contracts, …