Opinion ID: 1519864
Heading Depth: 1
Heading Rank: 17

Heading: Rationality of the Regulation

Text: In our review of the applicable legal standards, we noted that the regulation herein must be upheld if there is a rational relationship between its actual operative effect as enacted and the purpose it was designed to achieve. We have earlier seen that the regulation had a twofold purpose: (1) to remedy certain professional medical ethical abuses allegedly arising from the operation of acupuncture clinics in the District of Columbia, and (2) to meet health risks allegedly endangering the public from the use and administration procedure in acupuncture therapy. The record, however, does not support a finding that the effect of Section 1 of the regulation is rationally related to any valid legislative purpose presented to the committee and the City Council. In this connection we examine first the more significant health related purposes. Are acupuncture treatments inherently a danger to the health and welfare of the community? As we previously noted, few physicians who testified could relate any specific health complications caused by acupuncture treatments in the District of Columbia. Of the 8,000 patients treated at the Washington Acupuncture Center since 1972, the incidence of medical complications does not appear to be greater than those found in other comparable medical procedures. Testimony by plaintiff, Dr. Coan, indicated that, of the 7,000 patients who have received treatments at the Acupuncture Center of Washington, none has developed serious medical complications as a result of acupuncture therapy. It should be noted that this testimony relates to two of the four acupuncture clinics in operation since the enactment of Regulation No. 74-38the number of clinics in operation having apparently dropped from the record thirteen in early 1974. Testimony by C. Francis Murphy, Esquire, who is both a member of the Commission on Licensure to Practice the Healing Art and the Corporation Counsel for the District of Columbia, revealed that no complaint had been received by the Commission or his office from health authorities, patients or individual physicians regarding the specific treatment administered to acupuncture patients. This testimony was substantiated by Dr. Robinson in his testimony in open court, and by Mrs. Tebitts of the Department of Human Resources in her testimony before the Committee on Health, Welfare and Aging. Mrs. Tebitts indicated that any complaints received by her Department related solely to the operation of the clinics rather than to medical complications resulting from acupuncture therapy. The record is devoid of evidence of unique or special medical health hazards posed by acupuncture vis-a-vis any other recognized mode of medical therapy. As previously noted, a number of physicians testified on behalf of the D. C. Medical Society in order to inform the committee as to the inherent dangers in the practice of acupuncture. These witnesses (including Dr. Burton Epstein, former Chairman of the Ad Hoc Committee on Acupuncture for the D. C. Medical Society and for the American Society of Anesthesiologists, which was to collect cases of complication resulting from acupuncture treatment) could relate only a small number of cases in which patients developed any medical complications as a result of acupuncture therapy. Of this limited number of cases, only one could be shown to be the result of acupuncture therapy administered in the District of Columbia. The Court finds on this entire record that the incidence of actual serious medical complications arising from acupuncture therapy in the District of Columbia is insufficient to warrant a finding of an actual health hazard posed to the citizens of the District of Columbia by the modality of acupuncture therapy itself. In reaching this conclusion, the Court notes the possible greater incidence of serious medical complications resulting from alternative modalities of medical treatmentsuch as the administration of drugs with occasional severe adverse side effects, nerve destruction in some surgical procedures and complications arising from the administration of anesthesia. Dr. Shalom Albert further related under cross-examination that, although deaths have occurred in the District of Columbia in the past two years as a result of the administration of anesthesia, he knew of no fatalities as a result of the administration of acupuncture. Further, the evidence suggests that whatever hazards may exist solely from the use of needles for acupuncture therapy, they are to some extent similarly present in the use of needles by the several hundred unlicensed medical technicians who draw blood and take other specimens, as well as give injections. Dr. Mary Matthews, a pathologist and professor at George Washington University Hospital, testified that these medical technicians routinely insert needles without the presence or supervision of a physician. Dr. Matthews further testified that the possibility of medical complications developing, at least insofar as the use of needles was concerned, was more likely in the work of these medical technicians than through the administration of acupuncture therapy because the needles used by the technicians are generally twice as long as those used in acupuncture (2 mm. needles as opposed to acupuncture needles of less than 1 mm.). In considering the rationality of this regulation, the Court takes note of the state of the record before the City Council. At the time this matter came before the Court, no transcript had been made of the public hearings held on May 28th and 30th, 1974, by the Committee on Health, Welfare and Aging regarding the practice of acupuncture in the District of Columbia. In fact, it was only upon a court order making this testimony, along with the written statements submitted to that committee, a part of the record in the instant case, that these proceedings were finally made available in transcript form. Yet, even after such action by the Court, final oral arguments in the case had to be postponed for two weeks while the District endeavored to find and produce the evening session of the May 28th committee hearings. This transcript was finally made available to the Court and the parties, and included some of the most compelling testimony on record in the case. Needless to say, a transcript of the committee hearings was in no way made available to the City Council prior to their December 3, 1974 vote to enact Regulation No. 74-38. Rather, at that time, the only information on these public hearings before the City Council was a brief report on the hearings prepared by the committee chairman, Dr. Robinson. While it is true that when a duly authorized committee conducts hearings within an area of its authority, it may merely report its findings and recommendations to the legislative body, it is imperative that the committee's report give a full and accurate summary of the hearings held. The Court, having made a careful examination of the public hearings by the Committee on Health, Welfare and Aging, along with the written statements submitted to that committee, finds that the report submitted to the City Council gave a most delimited and circumscribed view of these acupuncture hearings, a view which did not fully reflect the flavor of the testimony and the interests affected by the recommended legislation. Insofar as reflecting the interests of patients, Dr. Robinson related in his report to the Council that most of the patients who testified related emotional experiences regarding their physical relief attributed to acupuncture treatments. Yet, he passed over other medical testimony which supported objective rather than subjective experiences. He stressed the fact that many of the patients who testified were nonresidents, yet the issue before the committee was not to whom treatments were given, but rather the quality thereof. Most importantly, he did not relate the constant and continuing nature of the treatments these patients were receiving, testimony which the Council could have found most helpful in enacting a reasonable regulation for the interim period while criteria for licensure and standards for clinics were to be developed. In his report to the Council, Dr. Robinson placed great emphasis on certain testimony regarding the use of acupuncture therapy for the treatment of nerve deafness and its apparent lack of effectiveness. Yet, he did not reflect contrary testimony which suggests that this area, more so than any other, encompasses a medically debatable issue on the efficacy of acupuncture treatments for such hearing disorders. Furthermore, in emphasizing the treatment of nerve deafness to such a degree, he failed to adequately report the favorable testimony adduced regarding the efficacy of acupuncture in treating other diseases and disorders. Of particular importance was the extensive testimony offered regarding the use of acupuncture for the treatment of chronic pain syndrome resulting from various conditions such as migraine headaches, arthritis, bursitis, sciatica, etc. Dr. Robinson, in urging the Council to enact a regulation limiting the practice of acupuncture to licensed physicians and dentists for the one-year interim period, furthermore did not accurately reflect either the testimony of certain medical experts or his own testimony regarding the reasonableness of such a regulation. For instance, the Chief Medical Officer of the District of Columbia, Dr. Raymond Standard, made no such recommendation to Dr. Robinson's committee. Rather, at page 5 of the May 28th transcript he is quoted as stating:    It is my view, however, that the city government should not discard or reject the practice of this procedure in the District of Columbia based on the lack of theoretical conclusions at present. Acupuncture treatment should be available to those who desire solace from it. And Dr. Robinson by his own testimony on two separate occasions questioned the reasonableness of this restrictive provision for the interim period. On page 16 of the transcript of the May 28th evening session in directing a question to Dr. Rosen, he stated as follows: Chairman Robinson: Well, now, all of our acupuncturist clinics in the District have to be run by a licensed M.D. of the District of Columbia. He is supposed to be present at all treatments. We found out that they are not always there but they are within a minute or so of a call if needed. Now since,  well, it seems apparent, doctor, to me, that we say that the American M.D.'s haven't had any training or very little training in acupuncture. Yet they have to supervise the acupuncture treatments and they know nothing about it. How do we get around that, see? Dr. Rosen: Well, that's stupid. Dr. Robinson: It is sir! And then again on page 86 of the same transcript Dr. Robinson stated to plaintiff herein, Dr. Ralph M. Coan, as follows: I don't agree with the fact but as the law is written now you can do all the acupuncture that you want. A man can do it in his office but it has to be an M.D. that does it. I don't agree the way this is, but I am talking about those people that you supervise that are not M.D.'s. Thus, it seems apparent that Dr. Robinson, in urging the Council to enact Section 1 of Regulation No. 74-38, did not accurately reflect the irrationality he himself saw in such a provision, much less the interests such a restrictive provision would adversely affect in its practical application. In this connection, the testimony of Dr. Emerson C. Walden, a member of the American College of Surgeons, and the former President of the National Medical Association who, in that capacity, visited the People's Republic of China in October, 1972, is pertinent. This testimony was not included in the committee chairman's report to the City Council. During the May 28th evening session of the committee hearings, in addition to relating many of the therapeutic possibilities of acupuncture, particularly with regard to its use in the relief of pain and disability, Dr. Walden elaborated on the concept of physician delegation in delivering total health care to the patient. According to his testimony many of the difficulties associated with our society's health care crisis relate to the lack of available primary health care personnel. According to Dr. Walden, physicians in practice do not desire nor can they be expected to perform individually or professionally all of the functions involved in patient care. As a means to alleviate this problem, Dr. Walden suggests that the physician, in his central role of management and responsibility for the patient's welfare, delegate not his own tasks but rather those health services viewed in terms of patient care which can be administered by nonphysicians. According to Dr. Walden, It is in this context that acupuncture should and must be viewed (a health service under the management and responsibility of physicians). To view acupuncture in the task delegation sense is again to mechanize the role of the physician and do little to enhance patient care. Dr. Walden, noting that there are few physicians who can practice acupuncture even in theory, summarizes his position as follows: Such being the case, a conflict between patient care and the task performance role of the physician necessarily arises. If in fact acupuncture is a beneficial service in patient care, and the task performance role of the physician is held paramount, and physicians cannot in fact function (perform) as acupuncturists, then patient care must suffer, which is in conflict with the goals and purposes of physicians in our health system. On the other hand, viewing the physician's central role as one of management and responsibility, such conflict does not need to arise, for there does exist a means to ensure the availability of acupuncture services in patient care via the use of nonphysician acupuncturists practicing under the management and responsibility of physicians   . The evidence in this record is inadequate to support a finding by this Court that the restrictive provisions of Section 1 of this regulation rationally relates to the public health care objectives sought with respect to the use of acupuncture. The difficulty with Section 1 is that it seeks to remedy a danger which has not been shown to exist (i. e., that acupuncture is inherently hazardous) by means which are not rationally related to such a purpose. An appropriate analogy might be drawn to a regulation banning the use of x-rays in the District of Columbia upon a finding that improper administration of x-ray may cause medical complications. While some protection would theoretically be afforded the public by limiting the practice of acupuncture to licensed physicians and dentists in that the patient would be assured that the individual administering the treatment was trained in anatomy, immunology, physiology and other basic medical sciences, the regulation is immediately stripped of its rationality by the almost total lack of physicians and dentists licensed in the District qualified to administer acupuncture. Purportedly enacted in the interest of protecting the public health, the regulation ironically authorizes any licensed physician or dentist to administer acupuncture treatments notwithstanding their total lack of any practical or theoretical knowledge as to the art of acupuncture. The regulation is also directed at problems relating to the procedures employed in the administration of acupuncture by the various clinics in the District of Columbia. It is in connection with this issue that the committee and Council evidenced a concern over the qualifications of the acupuncturists employed by the treating physicians. It is clear to this Court that there was ample evidence before the committee and Council relating to the need for licensing requirements and standards of practice to be followed by acupuncture clinics. In this connection, it appeared that the 1972 policy statement of the Commission on Licensure was evidently not being technically followed by the clinics in the sense that a licensed physician was actually physically present at all times throughout the administration of the treatment. It further appeared, however, that the physician would usually be in attendance at various stages of the treatment and at other times would be in close proximity to the patient. Accordingly, the Court finds that the present lack of any published standards to ascertain the qualifications of acupuncturists-therapists in the District of Columbia raises a sufficient potential health risk to warrant the adoption of Section 2 of the Regulation No. 74-38 requiring the Department of Human Resources to develop an examination and criteria for licensure of practitioners of acupuncture within one year. Pending development of these criteria, the medical ethical requirement that the therapists who are employed by a physician be adequately qualified to administer treatment directed by him, as well as the self-discipline and integrity of the medical profession, would seem to offer a proper safeguard for the community health. See Doe v. Bolton, supra, 410 U.S. at 200, 93 S.Ct. 739. While Section 2 is rationally related to this health care problem, Section 1 obviously is not, for the reasons outlined previously in considering the question of possible health risks inherent in acupuncture. Section 1, by eliminating the opportunity of physicians to prescribe and of patients to receive acupuncture therapy, even where the physician in his best judgment is satisfied that it will be administered in a qualified manner, does not rationally relate to this concern. We turn finally to the other basic purpose of this regulation, namely, the need to remedy possible ethical abuses involved in the practice of acupuncture in the District of Columbia, e. g., ownership of the clinics, advertising and treatment for financial gain. The record made at the public hearings and before this Court reveals at most the possibility that some unspecified physicians and centers may have engaged in unethical practices and some clinics may have been managed by individuals of questionable reputations. The mere possibility that such abuses may be substantiated by further investigation is a matter of proper concern to the District of Columbia Government and consequently the adoption of Section 3 of Regulation No. 74-38, requiring the Department of Human Resources to recommend minimum standards for clinics within six months, was a proper and rational exercise of legislative authority. Pending the development of the criteria relating to clinics pursuant to Section 3, many of the abuses fall more properly within the ambit of medical ethics and can be handled through appropriate disciplinary hearings within the medical profession. Further, the Corporation Counsel testified that his office is ready and able to deal with some of these alleged problems which may constitute violations of the Healing Arts Practice Act. To the extent that Section 1 of the regulation was promulgated to meet these ethical abuses, it is the finding of the Court that this provision has no rational relationship to that purpose. By restricting the practice of acupuncture to physicians, Section 1, which in no sense deals with the ownership of clinics or the use of advertisements, lacks a reasonable relationship to the objective of eliminating the problem of unethical practices by physicians and others engaged in the operation of acupuncture clinics.