Alternative Medicine: Expanding Medical Horizons ~ Introduction
 
   

Alternative Medicine:
Expanding Medical Horizons

A Report to the National Institutes of Health on Alternative
Medical Systems and Practices in the United States
 
   

Introduction


A glance at the history of the past twenty-five years will show how the regulatory challenge today differs from what it was in the early 1970s before the alternative medicine movement emerged into prominence. Prior to 1970 there was public and regulatory consensus on the nature and definition of medical "science". The vast majority of persons engaged in the practice of medicine were allopathic MDs grouped in local and state medical societies and represented nationally by the American Medical Association. Their main competitors were the osteopaths and chiropractors, with their own local and national organizations and with a recognized niche in the health-care picture. The attitude of the AMA was tolerance toward the osteopaths and non-recognition of the claims of the chiropractors. Naturopathic physicians were licensed in a very few states and ignored in all the rest. But these competing groups, with their different therapeutic philosophies and different medical "sciences", were left out of consideration in the public discussion of medical issues. The allopathic medical societies enforced "acceptable and prevailing standards" of medical care, and woe betide the physician who departed from them. Specifically, physicians were in serious risk of being professionally disciplined if they treated patients with the modalities which subsequently became known as "alternative".

A small handful of homoeopathic MDs practiced the homoeopathic medical "science", availing themselves of the protection afforded by incorporation of the Homoeopathic Pharmacopoiea in the 1938 US Food Drug and Cosmetic Law (the sponsor of this Law, New York Senator Royal Copeland, had started his professional life as a homoeopathic physician).

The prevailing view that the allopathic medicine practiced by the majority of physicians was scientific relieved the regulatory authorities of any real need to think about the philosophical basis of what they were doing. Any and all regulation along allopathic lines was assumed to be scientific, and there could not be any real conflict between "science" and the public interest. Few had given thought to the possibility that other medical "sciences" might exist, and those who might have queried the allopathic assumptions were never given the microphone.

The regulatory agencies approved medicine after medicine which post-marketing surveillance then revealed to be extremely dangerous to the recipient. But anyone who asked why the enormous US pharmaceutical industry could not produce, for instance, an antihypertensive medicine which did not cause tumors, swelling of the breasts, changes in the composition of the blood, cramping, vomiting, diarrhoea, skin eruptions, mental confusion, twitching, inability to achieve or maintain erection, irregular menses, growth of bodily and facial hair, gastritis, gastric bleeding, and ulcers (all these are adverse reactions to the antihypertensive Aldactone) was told that this was "scientific", and that’s just how things are done.

But not everyone agreed. In the late 1960s and early 1970s, for the first time ever, ordinary medical consumers began to question the recommendations of their family physicians who, it seemed, had little to offer but larger and larger doses of ever more toxic antibiotics for the commonest health problems of children and adults.

This consumer movement in medicine was part of a rising dissatisfaction with many social and political institutions, due in part to Ralph Nader’s criticism of the government’s regulatory and protective role and, in greater part, to the Vietnam War disaster. It drew support from a growing awareness of the environmental and ecological dimensions of social problems. Rachel Carson’s Silent Spring called attention to the dangers of agricultural chemicals and, by implication, to the chemicals used in medicine. A series of pharmaceutical scandals caused patients to think twice about the drugs they were being prescribed. Diethylstilbestrol (DES) given to pregnant women in danger of miscarriage caused genital deformities and cancers in their children, and even their grandchildren. Thalidomide, another medicine prescribed to pregnant women, also caused horrifying deformities in their children. The oral contraceptives turned out to be not without risk to the women taking them. These and other notorious episodes altered the public’s attitude toward medicinal drugs, which were now, in some cases, seen as inflicting damage rather than conferring benefit.

Many of these consumers found their way into homoeopathy, and medical students themselves were not far behind. Whereas prior to 1950 the small handful of physicians espousing this doctrine formed part of the 19th-century tradition, after 1968 students and recent medical school graduates sought out homoeopathy on their own, motivated by dissatisfaction with, and even antagonism toward, the doctrine they were being taught in the country’s "best" schools. For the first time in seventy years the homoeopathic movement started a period of vigorous growth.

The "health food" and herbalist movement was another potent ingredient in the new social fermentation. Consumers became convinced that commercially grown food, already found to be tasteless, was also devoid of nutritional value. The very soil on which the crops were grown was now regarded as "dead" from the overadministration of agricultural chemicals and incapable of producing tasty and nutritious food.

Many consumers became convinced that diseases themselves arise from poor nutrition and can be treated or cured by enhancing the patient’s nutritional status.

The movements for natural childbirth, midwifery, breastfeeding instead of commercial milk formulas, and for the reduction, suspension, or outright abolition of childhood vaccinations were part of this same maturation of health awareness.

In 1987 the chiropractors won a major lawsuit against the American Medical Association in which the latter admitted that it had engaged in systematic violation of the anti-trust laws.

The presiding judge concluded that "chiropractors outperformed medical physicians in treatment of certain conditions," that "some MDs believed chiropractic to be effective and DCs better trained to deal with musculoskeletal problems than most MDs," and that hospitals where chiropractic was part of treatment "released those patients sooner" than hospitals which excluded DCs. These findings, of course, were diametrically opposed to what the American Medical Association had been asserting about chiropractic for 75 years, casting considerable doubt on the scientific objectivity of this organization when criticizing its commercial competitors.

Chiropractors and the other traditional alternative healing modalities have all benefited hugely from this movement of public opinion. They and the osteopaths, naturopaths, and homoeopaths have more patients than they can handle. And new alternative treatments are springing up like mushrooms. A 1993 article in the New England Journal of Medicine shocked medical opinion with the announcement that in 1990 there were 425 million visits to providers of unconventional therapy in the US vs. 388 million visits to all primary care physicians (general and family practitioners, pediatricians, and specialists in internal medicine). Americans spent $13.7 billion on alternative therapy (including vitamins and dietary supplements) in 1990. In terms of out-of-pocket expenses, the American consumer in 1990 spent $10.3 billlion on alternative treatments, $12.8 on all hospitalizations, and $23.5 billion on all visits to allopathic physicians. This was seven years ago, and the gap today is considerably wider. But the allopathic physicians themselves are making greater and greater use of alternative modalities. The value of these physician-prescribe alternative medicines was estimated at $5 billion in 1996 by a member of th Health Quality Enforcement Section of the California Attorney General’s Office in Los Angeles.


II. Regulatory Problems in the 1990s

The allopathic paradigm of the 1950s is eroding around the edge under steady assault from the alterna-tive one. The certainty of that earlier era that allopathic medicine was "scientific" and, in essentials, immutable, has evaporated like the morning mist in the glare of increasing public support for alternatives. Patients are saying to themselves, "If this is science, then give me the opposite," and voting with their feet. For hypertension they are taking raw garlic or hawthorn berry tea and leaving Aldactone on the shelf.

But the regulatory authorities, which have traditionally coexisted in relative comfort with the allopathic paradigm and its representatives, carry on business as if nothing had changed.

As noted above, allopathy has always been regulated on the (largely unspoken) assumption that regulators were merely enforcing self-evident scientific standards and procedures. These same standards and procedures were then applied to non-allopathic modalities whose doctrinal structure is quite different. The FDA, for example, has regulated homoeopathy by trying to assimilate it to the allopathic paradigm, which is inappropriate for reasons discussed below (see Section VI). Attempts to assimilate acupuncture or chiropractic to the allopathic paradigm will be even more misdirected and futile.

Nearly all the alternative providers reject the allopathic paradigm in whole or in part, so how can they be regulated on the basis of this paradigm? And which is scientific — only allopathy, only alternative medicine, both allopathy and alternative medicine, or neither? If one or the other is not "scientific," on what basis is it to be regulated? And if two or three of the alternative modalities are "scientific," how do regulators cope with that?

Finally, are the regulatory authorities going to attempt to force down the throat of the public standards which the public itself no longer wants or recognizes? Major elements of public opinion already suspect that this is so. Eventually the public might become so irritated at this regulatory presumption as to demand abolition of medical regulation altogether.

While this may seem a purely theoretical possibility, it did indeed happen in the United States 150 years ago. In the 1830s homoeopathic and botanical medicine started contesting the dominance of allopathy which retaliated by refusing to license these "alternative" practitioners. The public became indignant and prevailed on the state legislatures to abolish the medical licensing laws. This country had no medical licensing for over 50 years, until it was restored in the 1890s.

So the history of the 1830s is full of meaning for regulatory authorities who claim to know better what the public wants than the public itself.


III. The Story of George Guess, MD

Licensing laws are commonly used to protect one group at the expense of other groups. While they are presented as a measure to protect the public, it is usually the members of the licensed group who are seeking protection — from actual or potential competitors.

It has often been noted that no movement in favor of professional licensing has ever been instigated by the public itself.

While this selfish aspect of licensing can never be entirely eliminated, awareness of it will help minimize its impact.

A prime example of how medical licensing laws have been used to protect the allopathic paradigm from competition, and how the public has reacted to it, is the case of Dr. George Guess. It is worth discussing in some detail because the arguments raised on the two sides are typical of those which will be presented in future controversies over "alternative" medicine.

Dr. Guess was a licensed allopathic physician in North Carolina who decided to practice homoeopathy. In 1985 he was summoned to a formal disciplinary hearing before the Board of Medical Examiners of that state and charged specifically with practicing homoeopathy, thus failing to conform to "acceptable and prevailing standards" of medical care in North Carolina. At the hearing the only charge was that his practice was neither acceptable nor prevailing in the state of North Carolina. No patient of Dr. Guess had ever complained, and no patient complaint was alleged by the Board.

In his defense Dr. Guess presented research on the efficacy of homoeopathy and its acceptability in other countries. Several patients testified in his behalf. The Board was not interested in any of this information; Dr. Guess was ordered to cease the practice of homoeopathy forthwith, and suffer a 2-year period of probation, or lose his license.

He appealed this to the state Superior Court and prevailed. The judge ruled that the Board’s action was "arbitrary and capricious," and unsubstantiated by the evidence. The Board appealed to the North Carolina Court of Appeals which again sided with Dr. Guess on the ground that some potential for harm to the public must be inherent in any unorthodox medical practice before it could be rightfully censured by the Board.

The statute applied against Dr. Guess stated specifically that charges could be brought "irrespective of whether or not a patient is injured thereby". The Court of Appeals interpreted this clause in the narrowest possible sense: to allow the Board to proceed against a physician practicing in an inherently dangerous manner without having to wait for actual patient injury.

But the Board then appealed the decision to the North Carolina Supreme Court which decided against Dr. Guess. Refusing to recognize any "fundamental right to receive unorthodox medical treatment," the Court determined that "the legislative intent was to prohibit any practice departing from acceptable and prevailing medical standards without regard to whether the particular practice itself could be shown to endanger the public... By authorizing the Board to prevent or punish any medical practice departing from acceptable and prevailing standards, irrespective of whether a patient is injured thereby, the statute works as a regulation which ‘tends to secure’ the public generally ‘against the consequences of ignorance and incapacity as well as of deception and fraud’, even though it may not immediately have that direct effect in a particular case".

One justice dissented, writing: "This is not the case of a quack beguiling the public with snake oil and drums, but a dedicated physician seeking to find new ways to relieve human suffering. The legislature could hardly have intended this practice to be considered ‘unprofessional conduct’ so as to revoke a physician’s license in the absence of some evidence of harm or potential harm to the patients or to the public. Nothing in the record before the Board or this Court justifies so broad a sweep in order to secure the public ‘against the consequences of ignorance and incapacity as well as of deception and fraud.’"

But Dr. Guess did not give up. He relocated to the more tolerant state of Virginia and continued his homoeopathic practice there. Meanwhile his patients, supported by the ACLU, filed suit in the Federal District Court against the Board on the following grounds:

  1. The Board’s action violates the patients’ Fourteenth Amendmen liberty interests in that it impermissibly intrudes upon the patients/fundamental right of access to informed, safe, and beneficial treatment by a licensed physician.


  2. The Board’s action exceeds its general police power (also a Fourteenth Amendent argument).


  3. Without the requirement of some harm or threat of harm to the public, the statute applied against Dr. Guess is unconstitutionally vague.


  4. The Board’s order violates the patients’ First Amendment rights to receive medical information.


  5. The Board’s action violates the Commerce Clause of the Constitution.


The case was ultimately dismissed on the ground that the patients lacked standing. But by this time the issue was moot, since in 1993 the North Carolina legislature, besieged by Dr. Guess’s patients, amended the medical examining law to read:

The Board shall not revoke the licence of or deny a licence to a person solely because of that person’s practice of a therapy that is experimental, nontraditional, or that departs from acceptable and prevailing medical practices unless, by com- petent evidence, the Board can establish that the treatment has a safety risk greater than the pre- vailing treatment or that the treatment is generally not effective. (G.S. 90-14[a][6])

The North Carolina Board bowed to this manifestation of democracy at work and graciously permitted Dr. Guess to return to North Carolina, but for the time being he remains at his new location in Virginia.

IV. Changes in Medical Licensing Laws Since 1990

As of May, 1997, seven other states had adopted legislation permitting the use of alternative medical treatment by MDs and prohibiting state medicalboards from disciplinary action against them for practicing alternative medicine.

Alaska in 1990 provided that "the board may not base a finding of professional incompetence solely on the basis that a licensee’s practice is unconventional or experimental in the absence of demonstrable physical harm to a patient". (A.S. 08.64.326[a][8][A]).

Georgia enacted a similar "Access to Medical Treatment Act" in April, 1997, permitting use of treatment which is "experimental [and/or] not approved by the FDA for such indication". The legislative intent was spelled out in the bill’s introduction as: "to provide that individuals have the right to be provided with any medical treatment desired or authorized under certain conditions". (Code, Section 43-34-42.1)

New York in 1994, after a three-year grass-roots struggle headed by Ms. Monica Miller, amended the licensing law to include unconventional medicine in the definition of medical "practice". It also defined "effective" treatment in the existing law to mean "has been shown to be effective but has not yet gained general acceptance in the United States". (Education Law, Section 6527(4); Public Health Law, Sec. 230, Subdivisions 1 and 10[a])

Oklahoma in 1994 was confronted with a medical society initiative to add "allopathic" to the name of the medical licensing board. In response to this the legislature amended the law to specify, inter alia: "Nothing in the Oklahoma Allopathic Medical and Surgical Licensure and Supervision Act shall prohibit services rendered by any person practicing nonallopathic healing practice"; "The Board shall not deny a license to a person otherwise qualified to practice allopathic medicine within the meaning of this act solely because the person’s practice or therapy is experimental or nontraditional"; and, "The Board may take disciplinary action ... The Board shall not revoke the license of a person otherwise qualified to practice allopathic medicine within the meaning of this act solely because the person’s practice is experimental or nontraditional". (O.S. Title 59, Sections 492(F), 493.1(M), and 509.10[2]). The legislative intent section (O.S. 59.480) explains that allopathic medicine does not include homoeopathy.

The Oregon legislature in 1995 enacted — over the veto of the governor who was himself an allopathic physician — the following amendments to the medical licensing law: "the use of an alternative medical treatment shall not by itself constitute unprofessional conduct". "Alternative medical treatment" was further defined as:

(I) A treatment that the treating physician ... has an objective basis to believe has a reasonable probability for effectiveness in its intended use even if the treatment is outside recognized scientific guidelines, is unproven, is no longer used as a generally recognized or standard treatment, or lacks approval of the U.S. Food and Drug Administration;

(II) A treatment that is supported for specific usages or outcomes by at least one other physician licensed by the Board of Medical Examiners: and

(III) A treatment that poses no greater risk to the patient than the generally recognized or standard treatment". (O. Rev. St., Section 677.190,Subsection (1).

Washington state in 1991 enacted the following provision: "the use of a nontraditional treatment by itself shall not constitute unprofessional conduct, provided that it does not result in injury to a patient or create an unreasonable risk that a patient may be harmed". (W. Rev. Code Ann., Section 18.130.180[4])

The Colorado law, enacted in April, 1997, is a hybrid of the New York and North Carolina laws: "’Alternative medicine’ means those healthcare methods of diagnosis, treatment, or healing that are not generally used but that provide a reasonable potential for therapeutic gain in a patient’s medical condition that is not outweighed by the risk of such methods. The board shall not take disciplinary action against a physician solely on the grounds that such a physician practices alternative medicine". (Col. Gen.Stat, Sec. 12-36-117) Adoption of this law was especially dramatic, since it had been watered down and consigned to "study committee" limbo by the physician-dominated House Health Welfare and Institutions Committee but was then resurrected by the House Appropriations Committee and adopted by unanimity in the House and Senate.

Massachusetts has had such a law on its books since 1901, specifying that the licensing law "shall not be held to discriminate against any particular school or system of medicine". (Gen.Law.Ann, Chap. 112, Sec. 7)

Furthermore, eleven states have naturopathic boards (Alaska, Arizona, Connecticut, District of Columbia, Hawaii, Maine, Montana, New Hampshire, Oregon, Vermont, and Washington), while three have homoeopathic boards (Arizona, Connecticut, and Nevada).


V. A Regulatory Framework for the Third Millennium

These changes in the medical licensing laws are reminiscent of the political situation in the 1890s, when medical licensing was reinstated after a 50-year hiatus. At that time the autonomous homoeopathic profession constituted 15 percent of all physicians in the country, and state legislatures would not pass a medical bill which did not have homoeopathic support.

In particular, adoption of medical licensing laws was hindered by allopathic insistence on a single examining board for all three medical professions — allopaths, homoeopaths, and eclectics (i.e., naturopaths) — and by the refusal of state legislatures to accept this allopathic condition.

New York, in 1890, was the first state to adopt a medical licensing law, and this happened only after the allopathic medical association, at legislative insistence, acceded to the homoeopathic demand that there be a separate examining board for each school of practice.

The New York Times editorialized approvingly on the outcome:

We may imagine what would be the result if the "single board" were applied to exami- nations in theology. The Roman Catholics, of course, as the most numerous body, would be entitled to the largest representation on such a board. Imagination reels appalled before the thought of summoning Episcopalian, Presbyterian, Methodist, and Baptist candidates for the ministry before such a tribunal. The homoeopaths and eclectics claim the same right to license their own graduates that the different churches possess, and there does not seem to be any good reason why it should not be conceded to them.

We look forward to the day when the Times will feature another such editorial.

In the meantime, 41 states have yet to amend their licensing laws. To facilitate this, and to assist the various regulatory agencies in accomplishing their own task, we should come to grips with an issue which has not yet been faced, i.e., the doctrinal or scientific basis of alternative medicine.

As stated earlier, the regulation of medicine has in the past been based on the implicit idea that allopathic doctrine represents transcendent "scientific" truth. Regulation has been imposed in the name of "science," not on behalf of some parochial allopathic need or demand. But as the public has demonstrated, confidence in the allopathic paradigm is diminishing, and the regulatory authorities can no longer base their actions exclusively on it.

For this reason we oppose the guidelines for the regulation and disciplining of physicians proposed by the Federation of State Medical Boards Special Committee on Health Care Fraud. To this Special Committee "fraud" is equivalent to "alternative medicine". It ignores the fact that the allopathic paradigm is steadily declining in the public esteem and attempts forcibly to resurrect it and impose it on all practitioners in the name of "science".

This is the thrust of its "Recommendation Two: State medical boards should develop criteria for evaluating any health care practice which has been called into question:". The following criteria are suggested:

"Is it based upon competent and reliable scientific evidence, including properly conducted clinical trials, and/or is it supported by a scientific rationale?"...

"Are the practitioner’s promotional claims supported by competent and reliable scientific evidence?"

Here "scientific" means nothing more than "allopathic," and adoption of this recommendation would come into conflict with the new medical licensing laws noted above and also with the expressed preferences of the public.

The requirement for "properly conducted clinical trials," while seemingly innocuous, is simply an effort to hobble the alternative practitioners. It reflects allopathic acceptance of the "entities" which are the subject-matter of allopathic clinical trials but not accepted by homoeopathy, acupuncture, chiropractic, and other alternative modalities (see Section VI below).

The homoeopathic pharmacopoia contains about 1200 different medicines, each of them used in a variety of diseased states. Running them through clinical trials, if a method for doing this could even be developed, would cost in the millions, or even billions, of dollars. Calling for "controlled clinical trials" in homoeopathy is tantamount to abolishing it altogether.

Many of the other suggested criteria would also impact unfavorably on one or another alternative treatment. The proposed diagnostic techniques, for instance, could be used against modalities such as homoeopathy, which uses symptomatic diagnosis, or acupuncture, which diagnoses from the pulse, or chiropractic which diagnoses by touch.

And the other recommendations, seeking to make the unlicensed "practice of medicine" a felony, with the "practice of medicine" defined as including, inter alia, "offering to... prevent or to diagnose, correct, and/or treat: any disease, pain, infirmity... or abnormal physical or mental condition," mean, if broadly construed, that a mother who gives aspirin to her child could go to prison for the rest of her life. While this is hardly likely to happen, the thrust of the recommendation is clearly to buttress a therapeutic modality (allopathy) which the public itself is rejecting and to provide a very broad base for its selective enforcement — primarily, one can be sure, against alternative practitioners.


VI. The Scientific Issues

As noted by us above, enforcement of the allopathic paradigm in the past has been predicated on the assumption that it represents and embodies medical "science". If allopathy were generally recognized as not embodying the whole of medical "science" but merely one way (among many) of organizing the scientific data into a paradigm capable of guiding medical practice, any attempt at enforcing this paradigm to the exclusion of others would be taken by the public as special pleading for one professional group over others equally deserving, an allopathic grab for power over the "alternatives" and a drive to suppress competition.

Thus the legal dispute over alternative medicine would be clarified if there was agreement on the following: is there "one" medical science or are there several? And how do we know?

Acceptance of the idea that different medical "sciences" exist would neutralize the allopathic argument that this or that alternative procedure cannot be justified or explained in terms of allopathic medical science, meaning, by implication, that the particular alternative modality is "unscientific" and valueless.

The regulatory implications are obvious. Is there to be one set of regulations for all, or is each discipline to be regulated differently, according to its own "science"?

But this issue is less complex than it appears, since the major alternative "sciences" — homoeopathy, acupuncture, classical osteopathy, and chiropractic — can be shown to possess a common body of doctrine which distinguishes them from allopathic "science". Other, less prominent, alternative modalities also share this common body of philosophical assumptions even though their "sciences" may not be as well structured philosophically as the four above-mentioned.

If the most popular and widespread alternative modalities can be seen to possess common features, this will limit the variety of alternatives with which the regulatory agencies must cope.

The above four alternative modalities share the following assumptions:

  • They are "vitalist" in regarding the living organism as possessing a vital force react- ing to environmental stimuli in sickness and health. Ordinarily the vital force maintains the organism in good health; "disease" is an impairment of the funct- ioning of this vital force, and, what is more, the process of becoming sick and recovering follows certain laws which the physician must know and respect;


  • These laws, or patterns of reaction, can be discovered only by observing the organism in sickness and health, not by studying inanimate matter; hence the alternative modalities downplay biophysics and bio- chemistry as sources of reliable informa- tion about the living organism, in favor of clinical observation and the study of symptoms;


  • Since the organism is always striving for health, medicines and procedures must be used which imitate and promote this effort; in homoeopathy it is the "similar" medicine which promotes this inherent striving, while acupuncture, classical osteopathy, and chiropractic have other techniques for furthering the organism’s intrinsic curative impulse;


  • These modalities consider that any thera- peutics which violates the healing impulse of the living organism is not truly curative but, in fact, intensifies the pathology, con- verting acute illnesses into chronic ones. It follows, in their view, that the vigorous practice of allopathic medicine generates much incurable chronic disease.


  • This body of knowledge has been known as the Empirical philosophy of medicine since classical times and is discussed at length in the Hippocratic writings.


The Empirical philosophy differs from allopathy — known since ancient times as medical Rationalism — in the following ways.

  • Rationalism rejects the concept of the vital force and views the living organism in mechanistic, physical ("biophysical"), or chemical ("biochemical") terms. It views the principles and the data devel- oped in the study of inanimate matter as an adequate reflection of the functioning of living matter;


  • It does not accept the idea that sickness and health are governed by rules which the physician must know and apply; to Rationalism "disease" is a sort of entity which exists above and apart from the physical bodies of the people suffering from this "disease";


  • Instead of medicines which further the organism’s curative impulse, it applies ones which supposedly operate against (contrary to) the patient’s "disease" or disease "entity". Antibiotics, for instance, are designed to kill a microorganism at the root of the patient’s "disease" and are not prescribed with any particular regard for the body’s intrinsic healing effort;


  • It is not systematically interested in the possibility that one disease, if treated in the wrong way, can progress into another one, specifically, that acute diseases can readily be transformed into chronic ones; chronic disease is not linked by allopathy to any preceding medical procedure; the fact that in the United States it increases from year to year is ascribed to the aging of the popu-lation.


  • From this summary description it is clear that regulatory agencies are confronted with two different, and opposed, medical "sciences" — Rationalist allopathy and the congeries of "alternative" disciplines which follow the assumptions of Empiricism.


Allopathic medical science is based on the assumption that disease entities actually exist. In a clinical trial the medicine is given to a group of patients assumed to be suffering from the given disease and compared with another group suffering from the same disease and getting a different medicine, or no medicine (placebo). The science is largely composed of the knowledge developed in these clinical trials.

Spokesmen for the alternative modalities often observe that this allopathic structure of clinical-science-based-on-clinical-trials is a wonderful ideal which is rarely if ever achieved in practice. In so doing they can quote the allopathic authorities themselves. For example, Donald Fredrickson, MD, Director of the National Institutes of Health, commented in 1977 that of 31,000 clinical trials during the previous decade in the field of gastroenterology, only 1% had been randomized; closer scrutiny of a sample of 100 led him to the conclusion that none satisfied the requirements for a convincing trial. Similar comments appear often enough in the literature to suggest a large gap between the ideal and the reality.

And the "off label" use of drugs, meaning their prescription for indications different from those for which they were originally licensed, is extremely widespread in allopathic practice. For many drugs the "off label" use may generate more income for the manufacturer than the "on label" use. This makes a mockery of the "controlled clinical trial" as the "gold standard" of drug use.

In any case, the various alternative modalities reject the very concept of the disease entity, proposing instead a much finer differentiation of patients into groups and subgroups. For example, to the homoeopaths the allopathic entity, "pneumonia," consists of 20 or 30 different types of pneumonia, in function of the origination and progression of the disease and the medicine or medicines the patient will need. An acupuncturist would probably subdivide "pneumonia" into an even larger number of subcategories — each with a different treatment — in function of the different patterns of pulse diagnosis. The same goes for chiropractic and classical osteopathy.

To these and other alternative modalities, the disease "entity" and the clinical trial predicated upon the existence of such an entity, seem a rather crude depiction of a complicated clinical reality.

Each of the alternative modalities has its own way of structuring its clinical "science," but they all differ radically from the "science" of allopathy.

In the past it seemed normal that the allopathic science should be viewed as the only medical science and that by enforcing it the regulatory agencies were enforcing some transcendent scientific or medical reality. This position prevailed for political reasons — because allopathy had the votes and the muscle. Today allopathy is losing some of that political muscle, allowing the Empirical "sciences" to come to the fore, and thus facilitating a more subtle and differentiated approach to diagnosis and treatment.

This offers a new challenge to the regulatory agencies.


VII. The Legal Issues

The legal issues involved in the regulation of medicine can be discussed much more coherently if the existence of more than one medical "science" is recognized. In fact, such recognition facilitates the task of the regulatory agencies, as they will then be relieved of the need to continually force square pegs into round holes.

The George Guess history need not be repeated, since an MD could be licensed by different licensing boards to practice any one of a variety of alternative modalities, and he or she would no longer have to fear being disciplined for preferring one mode of practice over another.

Such boards could also licence applicants who have not been through the allopathic training system, but have been trained elsewhere, and who want to practice only homoeopathy, or only acupuncture, or only herbal medicine, without getting involved in allopathy. The institution of such a licencing system would clearly respond to the public’s expressed preference.

Or a further step could be taken, permitting the practice of certain alternative modalities without any licencing requirement at all. This is the situation in England today, where the unlicenced practice of medicine is commonplace and well received by the public, and where the principal curb is the common law prohibition on fraudulent misrepresentation of educational qualifications.

In England the patient is assumed to have the good sense to contract for medical services as for other services in life. Are Americans less competent? Why should we not be allowed the same latitude? The English recognize that licensing is usually designed to protect the licencee, not the public.

The fact that alternative modalities are more user-friendly than allopathy makes such a course of action even more attractive. Acupuncture, herbalism, homoeopathy, and chiropractic are generally recognized as inherently safe. While an alternative practitioner can, of course, be wantonly negligent and thus inflict harm on the patient, the ordinary practice of these disciplines is not dangerous at all.

While they are criticized by allopathy on this ground as being mere placebos, the truth is that therapeutic modalities which operate with, rather than against, the organism’s own healing impulses are intrinsically less dangerous.

The typically allopathic idea that the only "effective" medicines are large doses of highly toxic substances is theoretical rubbish. But because allopathy insists on employing these intrinsically toxic medicines, to protect patients the allopathic licensing requirements should be stricter than those for the alternative modalities.

Allopathic fulminations about patients risking their lives by depriving themselves of "real" medicine may be dismissed as political posturing. Judging from the public’s expressed preference, it would be more accurate to say that patients risk their lives, and deprive themselves of real help, when they go to the allopath.

In any case, the trend of the past 25 years away from the allopathic paradigm and in favor of the alternative one shows no sign of slackening. The regulatory agencies cannot avert their gaze or pretend that it is not happening. A new approach is needed, based on a new understanding of the underlying scientific issues.

June 10, 1997

References:

Andrews, Lori B. Deregulating Doctoring. People’s Medical Society, 1983.

Chiropractic in New Zealand. Report of the Commission of Inquiry. Presented the House of Representatives by Command of His Excellency the Governor-General. Wellington, 1979.

Coulter, Harris L. The Controlled Clinical Trial: an Analysis. Washington, D.C.: Center for Empirical Medicine and Project Cure, 1991.

Coulter, Harris L. Divided Legacy: A History of the Schism in Medical Thought. Four Volumes. Washington, D.C.: Center for Empirical Medicine and Berkeley: North Atlantic Books, 1982, 1988 and 1994.

Eisenberg, David, et al., "Unconventional Medicine in the United States: Prevalence, Costs, and Patterns of Use". New England Journal of Medicine 328:4 (January 28, 1993), 246-252.

Federation of State Medical Boards of the United States. 1996 Annual Meeting. April 10-13, 1996. Panel on Fraudulent Medical Practices.



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