by Ellen Hodgson, UCLA Law Review, Feb 1977

To restrict the art of healing to one class of men and deny equal privileges to others will constitute the Bastille of medical practice. . . . The Constitution of this Republic should make special provision for Medical Freedom as well as Religious Freedom. INTRODUCTION

A correlative of the waning faith in the medical profession evidenced by the medical malpractice crisis2 is the recent revival of unorthodox methods of health treatment.3 This growing interest in health treatments not taug1~it in medical school, however, is primarily limited to the level of the theoretical. Individuals attempting to practice unconventional health treatments face legal barriers which effectively discourage all but the most determined.

Unorthodox health treatments4 exist in many forms, including
naturopathy,3 magnetic healing,6 hypnotism, herbalism and vita-

1 Benjamin Rush, Surgeon General of the Continental Army and signer
of the Declaration of Independence, quoted in B. INGLIS, THE CASE FOR UNORTHOuox MarnciNE 5 (1965).
2 See, e.g., Malpractice Nightmare, TIME, Mar. 24, 1975, at 62-63;
Rubsamen, Medical Malpractice, Sci. AM., Aug. 1976, at 18-23.
3 Fundamentally, the distinction between orthodox and fringe medicine today is that orthodox treatment relies mainly on fighting disease with the help of drugs or surgery, whereas unorthodox treatment concentrates on stimulating the patient’s constitution to fight on its own behalf, on the assumption that this is safer and more effective. . . . Man has built-in recuperative powers which can be seen at work when a cut heals into a scar, without attention; and this process, all fringe practitioners agree, can be speeded up, sometimes to an astonishing degree, by suitable stimuli. They believe that . . . it is the practitioner’s task to “hasten the mobilization of our own healing powers.”
B. INGLIs, supra note 1, at 297.
‘~ See generally id. at 15-64; H. KRUGER, OTHER HEALERS, OTHER CURES xii-xiii, 1-13 (1974). For an interesting instance of a professional athlete turning to “fringe” medicine, see Chapin, Roche Finds Unusual Cure: He Had Nothing to Lose Except Pain in His Arm, L.A. Times, July 13, 1975, § 3, at 11, col. 4. Chapin reports that Tony Roche, having given up professional tennis in 1973 due to “tennis elbow,” traveled to the Phillipines to patronize a “psychic surgeon.” The healer allegedly opened Roche’s arm, removed three blood clots and resealed the wound without instruments, after which Roche was able to return to an outstanding professional career.
~ Naturopathy is defined as “‘[niature cure or health by natural methods.’” Davis v. Beeler, 185 Tenn. 638, 642, 207 S.W.2d 343, 345 (1947),
appeal dismissed, 333 U.S. 859 (1948). See note 37 in! ra.
6 Magnetic healing is defined and discussed in 70 C.J.S. Physicians and mm therapy. Although most involve no drugs, surgical instruments or other potential means of harming the patient, all are proscribed to the unlicensed practitioner. Would-be practitioners of unconventional treatments regard as irrelevant the approximately twelve years of medical training required for obtaining a license7 and are unlikely to attempt this hurdle. The result is their virtual elimination as competitors in the American health market.
Nor does acquiring a medical license in itself guarantee freedom to venture outside established practices. In addition to strong economic pressures to conform,8 the licensed practitioner is subject to civil liability for malpractice and to criminal liability for using drugs, devices or methods not officially recognized as effective.9 A current controversy involves the drug laetrile, a plant derivative which, though reputedly harmless, is banned by the California Department of Health for use in the treatment of cancer.’0 The ban has been ignored by certain California physicians convinced of the drug’s effectiveness as a cancer treatment, a conviction for which they have had to face criminal charges.’1 Because the laetrile controversy raises questions about the propriety of bureaucratic restrictions not only on physician discretion but also on the individual’s right to choose his own health treatment, it shall be used in this Comment as a vehicle both for evaluating federal and state drug regulations and for illustrating the judicial attitude toward health treatment restrictions.
The focus of this Comment will be on the restrictions faced
by the practitioner in California, a state in which both unorthodox approaches to health’2 and statutory anti-quackery proviSurgeons § 1(1975):
The term “magnetic healer” has been used in referring to certain persons whose method of treatment consisted of kneading and manipulation of the muscles, and rubbing of the body with the hands, without the administration of drugs. “Magnetic healing” has been referred to as a method of treatment contrary to the teachings of the ancient and honorable schools of medicine and surgery, although it has been said that the practice of magnetic healing is based on some elements of ascertained knowledge.
Id. at 807 (footnotes omitted).
See text accompanying note 50 in! ra.
8 See notes 101-03 & accompanying text infra.
~ See notes 62-100 & accompanying text infra; see also 61 AM. JUR. 2D Physicians, Surgeons, Etc. § 16 (1972):
A license issued to a physician gives to him a mere naked privilege of practicing medicine, or rather, an immunity from punishment because of practice without a license. It does not give to him the right to practice free from police regulation by the state.
Id. at 136.
10 See notes 93-100 & accompanying text in! ra.
11 See notes 213-34 & accompanying text inira.
12 See, e.g., J. BAUR, HEALTH SEEKERS OF SOUTHERN CALIFORNIA 48-49

(1959). The author asserts that the “health rush” was more instrumental than the sions” have proliferated. Where California law is insufficiently definitive, reference will be made to the law of other states. These legal restrictions will then be evaluated in terms of policy—with an emphasis on economic effects—and constitutional considerations. Finally, proposed alternative approaches to regulation of treatments which are harmless but not of established effectiveness will be presented and evaluated.

I. RESTRICTIONS ON THE UNLICENSED:

THE LICENSING REQUIREMENT

The major barrier to the practice of unorthodox health treatments by laypersons is the existence, in all state codes, of medical practice acts limiting the practice of the healing arts to the licensed. The California licensing provision, entitled the Medical Practice Act (Act), which is typical, provides:
Any person, who practices or attempts to practice, or who advertises or holds himself out as practicing, any system or mode of treating the sick or afflicted in this state, or who diagnoses, treats, operates for, or prescribes for any ailment, disorder, injury, or other mental or physical condition of any person, without having at the time of so doing a valid, unreyoked certificate as provided in this chapter . . . is guilty of a misdemeanor. 14
While the terms are designed to be all-inclusive, so that a license is required for the practice of virtually any form of health treatment, the difficulty of satisfying the requirement effectively bars most proponents of unconventional treatments from attempting to become licensed. As a result, a monopolistic professional domain has been created, and unorthodox schools of health treatment have been eliminated as competitors.

A. Historical Growth of a Professional Domain

As California’s Medical Practice Act now reads, a medical license is required for the practice of any method of treating the sick. However, the range of healing arts covered by the California Act has not always been so broad. Earlier medical practice acts essentially limited the charge of “practicing medicine” to those who used drugs, performed surgery or professed to be doctors.’5 In addition, earlier acts made available an intermediate

Gold Rush in the development of Southern California, and particularly of Los
Angeles, which he labels “the Capital of the ‘Sanitarium Belt.’” Id. at xi n.33.
13 See Note, Quacke,y in California, 11 STAN. L. REV. 265, 268-69 (1959)
[hereinafter cited as Quackery].
14 CAL. BUS. & PROF. CODE § 2141 (West 1974).

15 The narrowness of the licensing law at the turn of the century may be
seen in the following excerpt from an early California case:
The act of 1901 . . . provided …:“The following persons shall be
deemed as practicing medicine or surgery . . . : 1. Those who profess
type of license, the prerequisites of which were less stringent than those for the physician’s and surgeon’s license.’6 This “drugless practitioner’s license,” “authorizing the holder to practice any other system or mode of treating the sick or afflicted, not otherwise referred to,”17 was distinguished from the physician’s and surgeon’s license in that the practitioner was forbidden the use of drugs or surgery.’8 The law providing for this license, along with that providing for a special license for midwives, was repealed in California in 1949.’~

B. Defining the Practice of Medicine

Elimination of the drugless practitioner’s license by the legislature, together with an expansive reading of the terms of states’ medical practice acts by the courts, has extended the territorial domain of the medical profession to cover the entire field of “healing disease and preserving health.”20 In California, “diagnosing,”

to be . . . engaged as doctors . . 2. Those who, for pecuniary or valuable consideration, shall prescribe medicine . . . . 3. Those who
shall employ surgical or medical means . . . . 4. Those who
prescribe or use any drug or medicine, appliance, or medical or surgical treatment There was thus given by that act to the term “practicing medicine or surgery” a definite meaning, corresponding substantially with the popular understanding of the term.
Ex parte Greenall, 153 Cal. 767, 768-69, 96 P. 804, 805 (1908), quoting Act of Feb. 27, 1901, ch. 51, § 16, [1901] Cal. Stat. 63. In contrast to the current provision, no mention was made in the 1901 Act of practicing “any mode or method of treating the sick” or of “diagnosing,” and “prescribing” was included only in conjunction with medicine or surgery, rather than as constituting the practice of medicine per se. See note 21 in! ra.
The 19th century licensing laws were even less restrictive. See, e.g., Act of
Apr. 3, 1876, ch. 576, § 5, [1877-78] Cal. Stat. 920:
Any person shall be regarded as practicing medicine, within the meaning of this Act, who shall profess publicly to be a physician, or who shall habitually prescribe for the sick, or who shall append to his name the letters “M.D.”; but nothing herein contained shall be construed to prohibit gratuitous services in cases of emergency.
Id.
16 See Oosterveen v. Board of Med. Examiners, 112 Cal. App. 2d 201,
207 n.3, 246 P.2d 136, 140 n.3 (2d Dist. 1952).
‘7 Millsap v. Alderson, 63 Cal. App. 518, 521, 219 P. 469, 471 (2d Dist.
1923).
18 Under one form of certificate the holders thereof, as provided in the act, may not only prescribe and use drugs, but may also sever and penetrate with a knife the tissues of human beings. The holders of other certificates are drugless practitioners, and they may not prescribe or use drugs, nor may they operate with a knife or in that way sever or penetrate the tissues of human beings, except that they may sever the umbilical cord.
People v. Chong, 28 Cal. App. 121, 123, 151 P. 553, 554 (1st Dist. 1915).
‘9 Act of June 2, 1913, ch. 354, § 10, [1913] Ca]. Stat. 722, 728, repealed by
Act of May 13, 1949, ch. 233, § 3, [1949] Cal. Stat. 457, 458. This author was unable to discover the reason for the repeal.
20 State v. CatcHier, 63 Wyo. 123, 164, 179 P.2d 203, 218 (1947) (definition
of medicine).

“treating,” and “prescribing” may each independently constitute the practice of medicine.21 Further, “diagnosing,” “treating,” “prescribing,” and “any mental or physical condition” as legally defined have become broadly inclusive terms, which courts have tended to apply literally, without reference to policy considerations.22

1. “Diagnosing”

The California statutory definition of “diagnosis” includes “any undertaking by any method . . . whether gratuitous or not, to . . . establish whether or not a person is suffering from any
disorder.”23 A diagnosis need not be express. Thus, a California court has upheld the conviction of a practitioner who adjusted vertebrae on the ground that he diagnosed without a license, though the practitioner argued that he had made no representations to his patients concerning the nature of their ailments;24 each patient received a vertebrae adjustment, regardless of ailment. In order to find the practitioner guilty of unlicensed practice, however, the court had to find that he had diagnosed. Accordingly, the court reasoned that diagnosis could not be dissociated from the art of healing itself and that “diagnosis may be established by acts and conduct as well as by any representations which might be made to a patient.”25
Though the issue has not been litigated in California, an appellate court in Texas, which has a medical practice act essentially similar to California’s,26 has held that dissemination of printed

21 People v. Saunders, 61 Cal. App. 341, 215 P. 120 (2d Dist. 1923). The defendant, convicted of practicing a system of treating the sick without a license, argued that he was not practicing medicine because he did not diagnose. The court rejected this defense on the ground that diagnosing was not a necessary element of the offense:
It is at once apparent from [its] language that the legislature intended to denounce the act of anyone who, not having a license, might diagnose without treating or prescribing, or who might treat or prescribe without diagnosing .
Sd. at 344, 215 P. at 121.
22 The policy considerations underlying restrictive health legislation are discussed at notes 109-54 & accompanying text in Ira.
23 CAL. BUS. & PROF. CODE § 2013 (West 1974). In accordance with this definition, a midwife who took the blood pressure of expectant mothers was convicted of diagnosing and thus practicing medicine without a license. Board of Med. Examiners v. Casserley, Civ. No. 11239 (Cal., 4th Dist. Mar. 19, 1973).
24 People v. Parish, 59 Ca]. App. 302, 210 P. 633 (2d Dist. 1922).
25 Id. at 302, 210 P. at 634. See also State v. Howard, 216 Iowa 545,

550-51, 245 NW. 871, 874 (1932), discussed in text accompanying notes 58-61 in Ira. The Parish court concurred in the defendant’s contention that diagnosis was an essential element of the practice of medicine. But see note 21 & accompanying text supra.
26 TEX. REV. Civ. STAT. ANN. art. 4510a (Vernon 1976).
matter could constitute diagnosis and treatment. In Kelley v. Texas State Board of Medical Examiners,27 a dentist was enjoined from publishing his book, One Cure to Cancer, on the ground that the book involved “diagnosis, treatment, and offer of treatment and therefore constituted the practice of medicine 28
The court’s definition of “diagnosis” in each of these cases is strained beyond the popular understauiding of the term. The motive behind these definitions appears to be to ensure that the sick turn only to licensed physicians for treatment. Where cancer is involved, as in the Texas case, straining the statutory language may be justified in terms of the state’s interest in assuring that cancer patients receive orthodox treatment at an early stage. In the case of the vertebrae adjustor, however, the state’s health interest is less apparent. The more obvious interest being served is the preservation of the monopoly of organized medicine. This observation is equally applicable to judicial decisions interpreting other terms of the Act.

2. “Prescribing”

While “prescribing” is nowhere explicitly defined by California statute or case law, the California Attorney General has concluded that prescribing is synonymous with “recommending. “29 In addition, vitamins used for medicinal purposes were determined to be drugs.30 According to this opinion, a pharmacist who recommends vitamins after being told a customer’s symptoms is practicing medicine without a license.3’ Similarly, Chinese herbalists who recommended herbs after being told their customers’ symptoms have been held by a California court to be prescribing and thus engaging in unlicensed practice,32 in spite of the fact that consumers

27 467 S.W.2d 539 (Tex. Civ. App. 1971), cert. denied, 405 U.S. 1073,
rehearing denied, 407 U.S. 916 (1972).
28 467 S.W.2d at 544-45. The court considered the book to be an advertising scheme to secure patients for the defendant and analogized its sale to the sale of will forms by untrained laymen, which in Texas constitutes the practice of law without a license. Id. at 545.
29 23 Op. CAL. Arry GEN. 62, 66-67 (1954).

30 Id. at 66-67.
31 Id. at 62. Television advertisers may, however, recommend over-the-counter drugs for particular ailments without being licensed. One possible explanation for the distinction is the greater danger of actual reliance on the advice of a druggist than on that of an advertisement. A second possible explanation is the interdependence of the drug and medical industries, whose lobbies exercise formidable power over legislatures. See B. EHRENREICH & J. EHRENREICH, THE AMERICAN HEALTH EMPiRE: POWER, PROFITS, AND POLITICS 95-124 (1970); J. PEKKANEN, THE AMERICAN CONNECTION: PROFITEERING AND POLITICKING IN THE “ETHiCAL” DRUG INDUSTRY 112-43 (1973).

32 People v. T. Wah Hing, 79 Cal. App. 286, 249 P. 229 (3d Dist. 1926);
People v. P00 On, 68 Cal. App. 756, 230 P. 193 (3d Dist. 1924).

may treat themselves unadvised, by purchasing herbs and books which give instructions in their use. The New Jersey Supreme Court has gone still further: It has held that a foodstore owner was prescribing and diagnosing when, after being told a customer’s symptoms, he recommended brand-name packaged products for relief of the symptoms and gave advice concerning the products’ use.33 The court considered the question of whether the recommended products were classified as medicines to be irrelevant.34 Finally, a Delaware court has broadly defined “prescribing” to include “any direction,” whether written or oral, for “remedies for the cure of bodily diseases,” including “powders, plasters, baths of alcohol, whisky, or mud, or other remedies of any kind.”35

3. “Treatment”

The language of the California Medical Practice Act forbids the practice of “any mode or method of treatment” by unlicensed persons. Treatment, like diagnosing and prescribing, is defined by the courts in its broadest sense. The treatment need not involve drugs, surgical instruments, or remuneration. Thus a California court has held that naturopathy or “nature cure,”36 a healing system which refrains from using drugs or surgery on doctrinal grounds,87 may nevertheless not be practiced without a medical license.38 In other jurisdictions, unlicensed magnetic or psychic healers, whose treatment involves only a light touch on the body, have been held to be practicing medicine illegally.39 And the United States Supreme Court has held the same to be true of a

33 Pinkus v. MacMahon, 129 N.J.L. 367, 368, 29 A.2d 885, 886 (1943).
3~ Id.
35 State v. Lawson, 22 Del. 395, 396, 69 A. 1066, 1067 (1908) (practitioner employing a treatment which combined hypnotism and massage held practicing medicine on grounds he indicated remedies).
36 Davis v. Beeler, 185 Tenn. 638, 642, 207 S.W.2d 343, 345 (1947).
37 See Millsap v. Alderson, 63 Cal. App. 518, 219 P. 469 (2d Dist. 1923):
The articles of incorporation . . . of the [California] Association of Naturopaths [state its purposes to be] “to seek, teach and embody truth, principally to study nature, mind and man . . . and to teach naturopathy, ‘in its theoretical, practical modes of restoring and maintaining health . . . .‘ The materia medica shall consist of light, air, water, clay, heat, besides rest, diet, herbs, electricity, massage, Swedish movements, suggestive therapeutics, chiropractic, magnetism, physical and mental culture, etc., etc. .
Id. at 526-27, 219 P. at 473.
38 Oosterveen v. Board of Med. Examiners, 112 Cal. App. 2d 201, 205-06,
246 P.2d 136, 139-40 (2d Dist. 1952).
39 See, e.g., Parks v. State, 159 md. 211, 64 N.E. 862 (1902) (magnetic healer); State ex rel. Bierring v. Robinson, 236 Iowa 752, 19 N.W.2d 214 (1945) (psychic healer); State v. Hughey, 208 Iowa 842, 226 NW. 371 (1929) (“laying on of hands”). Cf. People v. Trenner, 144 Ill. App. 275 (1908) (unlicensed practitioner employing the “Weltmer method,” combining mental suggestion with massage, held practicing medicine illegally).

practitioner employing mental suggestion, though the treatment involved no physical contact with the patient at all.40 That the treatment is gratuitous is legally irrelevant;4’ so also is the fact that the treatment is successful.42 A California court has gone so far as to assert that satisfied patrons of an unlicensed practitioner who prescribed home-made remedies without charge could be held guilty of conspiracy.43

4. “Any Mental or Physical Condition”

The phrase “any . . . mental or physical condition” has similarly been judicially defined in its broadest sense. The “condition” treated need not be one of “disease” in the ordinary sense of the word. Thus the term has recently been held to include pregnancy, resulting in the conviction of a midwife for the

40 Crane v. Johnson, 242 U.S. 339 (1916). The Court noted that although the defendant did
not employ either medicine, drugs or surgery in his practice, nor [was] there anything harmful in it to the individual or dangerous to society
[he didl employ in practice faith, hope, and the processes of mental
suggestion and mental adaptation.
Id. at 340. The Court held that this mode of treatment was distinguishable from prayer and thus not exempt from the licensing requirement. Id. at 342. The Court’s basis for distinguishing mental suggestion from prayer was that prayer requires no ability to distinguish between specific diseases and therefore no special knowledge. id. at 344. For the current version of the California statutory prayer exemption, see note 167 infra.
41 People v. Vermillion, 30 Cal. App. 417, 418, 158 P. 504, 504 (2d Dist.
1916) (appellant’s contention he could not be convicted of practicing without a license unless it were shown he charged for his services held erroneous on grounds remuneration is not an element of the statutory language).
42 People v. Saunders, 61 Cal. App. 341, 345, 215 P. 120, 122 (2d Dist.
1923).
~3 People v. Albrexstondare, 71 Cal. App. 339, 344, 235 P. 87, 89 (2d Dist. 1925). The defendant, although stating to the patient’s relatives that he was not a doctor and would not prescribe or treat, gave the patient home-made remedies and was therefore held to be practicing medicine without a license. The patient’s relatives were deemed to be accomplices of the defendant, the court stating:
Assuming . . . actual knowledge [of defendant’s lack of statutory qualifications] by the members of the family, and constructive knowledge on their part that the law forbade anyone to treat the sick without “then and there having a valid unrevoked certificate of license from the board of medical examiners of the state of California,” it would seem probable that they occupied a position not differing in law from that occupied by any person not a member of the patient’s family who assisted in such treatment.
It may perhaps be considered a hard law which, without incurring severe legal consequences, will not permit the members of the family of an afflicted person to actively assist and co-operate with one who is not licensed to practice the medical profession in what may be an honest endeavor in good faith to relieve human suffering. . . . [Y]et the language of the statute and the decisions of the courts do not permit of the exercise of discretion as to when or under what circumstances the letter of the law may be disregarded.
ld. at 344-45, 235 P. at 88-89.

1977] RESTRICTIONS
655
unlicensed practice of medicine.44 Another California court has held that the term includes obesity and nervousness, upholding the conviction for unlicensed practice of a practitioner who attempted to alleviate these conditions through hypnotism.45 The latter court did not base its holding on the potential danger to the patient’s health posed by hypnotherapy.46 It simply presented the terms of the Act, defined them, and concluded that the practice in question fell within the ambit of the Act. Here, as in the cases previously cited, the focus of the court was on a literal application of the law to the facts, without reference to the health interest of the patient. While it might be relevant to consider the potential threat posed by the treatment to the patient’s health, or the possibility that the patient would detrimentally rely on the practitioner’s advice, the courts have not done so. The result has been conviction of practitioners for treatments which neither endanger the patient’s health nor involve any detrimental reliance by the patient.

C. The Medical School Barrier

As a result of broad judicial interpretation of an already broad legislative definition of the practice of medicine, anyone wishing to enter the field of healing is faced with the hurdle of first acquiring a license. That the hurdle is high is primarily due to the stringent nature of the licensing prerequisites: completion of medical school and a hospital internship.47 These prerequisites are a barrier to aspiring practitioners of the unconventional for several reasons. One is economic: The yearly cost of educating a doctor is estimated at $12,65O.~~ Another is the difficulty of gaining medical school admission: For each applicant accepted, close to two are turned away.49 A third is the cost in time: Becoming licensed requires four years of college in a “pre-med” major, four years of medical school and from three to seven years of postdoctoral training.50 A fourth is the irrelevance of most orthodox to most unorthodox medical treatment. The naturopath, for

44 Board of Med. Examiners v. Casserley, Civ. No. 11239 (Cal., 4th Dist. Mar. 19, 1973).
~ People v. Cantor, 198 Cal. App. 2d Supp. 843, 18 Cal. Rptr. 363 (Super. Ct. 1961).
46 Since laypersons not possessing medical degrees may, in a non-health context, practice hypnotism unregulated, the court could not have based its holding on the inherent dangers of the technique.
47 CAL. Bus. & PROF. CODE § 2192 (West Supp. 1976).
48 Culliton, Medical Education: Institute Puts a Price on Doctors’ Heads,
183 Sd. 1272 (1974).
~9 For the academic year 1972-73, the 13,500 first-year places in medical school had 35,500 applicants. Goldhaber, Medical School Admissions: A Raw Deal br Applicants, 177 Sd. 332 (1972).
50 Ebert, The Medical School, Sci. AM., Sept. 1973, at 139, 146.

656

UCLA LAW REVIEW
[Vol. 24: 647

example, who eschews drugs and surgery, has little incentive to learn to wield these tools. Moreover, any nonconformist leanings the freshman medical student may entertain tend to be filtered out in the educational process.5’ As one doctor observes:

The formidable and rigorous training process is itself a prolonged screening period wherein the student or young intern is carefully observed, not so much to insure that he dispenses quality care, but that he adheres to the rules and regulations of his profession. Only the most conforming and abiding survive this screening process. Rigorous training and screening not only enforce conformity, but frighten away a good deal of competition.52

Dissenters who do not survive the screening process, who drop out for doctrinal reasons53 and proceed to practice methods not taught in medical school, risk criminal charges for practicing without licenses. To illustrate, one unorthodox medical practice now gaining public acceptance is natural childbirth. In a recent case, however, a California trial court enjoined from further practice a remarkably successful male midwife who assisted mothers in this method, on the ground that he was practicing medicine without a license.54 The defendant had dropped out of medical school because of his refusal to speed childbirth by surgery and anesthesia.55 During twenty-five years of practice as a midwife he had, without using drugs or forceps, delivered 3,500 babies with no fatalities or serious complications.56 He was enjoined from his career in spite of his unusual success and the protests of his former patients.57 In a somewhat similar Iowa case,58 the defend ant had practiced “naprapathy,” a technique involving manipulation of connective tissue,59 for over twenty-one years. When he applied for a license, it was refused. Though naprapathy used no medicine or

~‘ The medical curriculum is to a great extent standardized, and nobody can qualify as a doctor except by spending six years or more on predominantly allopathic training. Other systems of medicine are not taught; as a rule they are not even mentioned, except disparagingly in lecture-hall asides. And orthodox teaching, as members of the profession have often lamented, has begun to resemble a form of Pavlovian conditioning, rather than education in any deeper sense of the term.
B. INGuS, supra note 1, at 59-60.
52 R. KUNNES, YOUR MONEY OR YOUR LIEn 15-16 (1971).

58 See note 3 supra.
54 Board of Med. Examiners v. Casserley, Civ. No. 11239 (Cal., 4th Dist. Mar. 19, 1973).
~ Mister Midwife of San Diego, PREVENTION, June 1972, at 84. 56 Id.

57 Id. at 89. Cf. Bowland v. Municipal Ct., 45 U.S.L.W. 2293 (Cal. Sup.
Ct. Dec. 6, 1976) (statutory prohibition against unlicensed practice of midwifery upheld against claim that it violated mother’s constitutional right of privacy).
58 State v. Howard, 216 Iowa 545, 245 NW. 871 (1932).
~ Id. at 546-47, 245 N.W. at 871-72.

1977] RESTRICTIONS
657
surgery, the court held it nevertheless constituted the practice of medicine because it involved diagnosis,60 and enjoined its practice.6’

II. RESTRICTIONS ON LICENSEES

Even after acquiring a medical license—which theoretically authorizes the use of “any and all . . . methods in the treatment of diseases, injuries, deformities, or other physical or mental conditions”62—the practitioner is actually limited by legal and professional restrictions in the choice of treatments he may employ.

A. Legal Restrictions

First, the licensed medical practitioner is subject to tort liability for conduct which is not that of the average reasonable practitioner; that is, conduct which is not “customary and usual in the profession.”6’ “[C]ustomary and usual” conduct is by definition orthodox conduct.64 Second, the licensed practitioner is subject to various state code provisions designed to curtail medical “quackery”;65 that is, “cures” known by their proponents to be ineffective and marketed with the intent to defraud. These provisions, while designed to curtail fraud, can also be invoked to restrict treatments which though unorthodox are propounded in good faith. California sanctions include injunctions and criminal prosecution for adulteration,66 misbranding,67 false and misleading labeling,68 treatment of cancer patients with drugs or devices not

60 Id. at 551, 245 N.W. at 874.
61 ld. at 553, 245 NW. at 874.
02 CAL. BUS. & PROF. CODE § 2137 (West Supp. 1976).
65 w PROssER, TORTS 165 (4th ed. 1971). Language typically used by the courts in defining malpractice is “the neglect . . . to apply that degree of skill and learning in treating a patient which is customarily applied in treating and caring for the sick or wounded similarly suffering in the same community.” Valentin v. La Soci~t~ Fran~aise, 76 Cal. App. 2d 1, 5, 172 P.2d 359, 362 (2d Dist. 1946).
64 Prosser notes:
Where there are different schools of medical thought . . . the doctor is entitled to be judged according to the tenets of the school he professes to follow. . . . [H]owever . . . a “school” must be a recognized one with definite principles, and it must be the line of thought of at least a respectable minority of the profession.
W. PROSSER, supra note 63, at 163. Where the practitioner is of a school of the
“respectable minority,” language typically used by the courts is:
A practitioner is . . . required by law to use the same degree of care, diligence and skill in the treatment of his patients as is possessed and used by prudent, skilful and careful practitioners of the same school practicing in the same vicinity.
Howe v. McCoy, 113 Cal. App. 468, 470, 298 P. 530, 530 (4th Dist. 1931).
65 See generally Quackery, supra note 13, at 269.
66 CAL. HEALTH & SAFETY CODE §§ 26520 et seq. (West Supp. 1976).
67 Id. § 26550.
68 Id. § 26630.

1 approved by the Food and Drug Administration (FDA),60 operation of a clinic without a license,70 and attempts or conspiracies to commit acts detrimental to the public health and safety.” Third, the licensed practitioner is subject to similar federal provisions based on the commerce clause, including prohibitions against false advertising,72 misbranding,73 and mail fraud.74 While the physician is therefore free in theory to treat according to his best professional judgment, in practice he may be criminally sanctioned if his professional judgment differs from that of various administrative agencies.
The principal federal agency with which practitioners must contend is the FDA, an agency which has traditionally played an aggressive role in eliminating treatments it considers to be quackery.75 An early, well-publicized case of a physician under FDA fire for propounding unorthodox cures involved Dr. Wilhelm Reich,76 whose “orgone therapy,”77 a radical and much maligned offshoot of Freudian psychoanalysis developed in the 1930’s, has recently generated renewed interest.78 Dr. Reich invented an “orgone energy accumulator,”79 which was reputed to be beneficial

89 Id. § 1707.1 (West 1970).
70 Id. § 1200.
71 CAL. PENAL CODE § 182 (West 1974).
72 15 U.S.C. §§ 52, 54 (1970).
73 21 U.S.C. § 352 (1970).
74 18 U.S.C. § 1341 (1970).
7~ The American Medical Association, which has historically led the crusade against quackery and nostrums, was the primary motivating force behind enactment of the Pure Food and Drugs Act. See J. BURROW, AMA: VOICE OF AMERICAN MEDICINE 67-92 (1963).
76 Reich v. United States, 239 F.2d 134 (1st Cir. 1956), cert. denied, 352
U.S. 1004 (1957).
77 “Orgone therapy” differs from Freudian psychoanalysis in that character transformation is approached on a physical rather than a psychic level. Elkind, Wilhelm Reich—The Psychoanalyst as Revolutionary, N.Y. Times, Apr. 18, 1971, § 6 (Magazine), at 68. Reich believed that emotional and physical health depend on the free flow through the body of what he called “orgone” energy, from the root word “organism,” defined as “the life force, not in any mystical sense, but physically.” 0. BEAN, ME AND THE ORGONE 7 (1971). The goal of orgone therapy is to shatter the patient’s “character armor”—those “chronic physical attitudes (stooped shoulders, stiff posture and so on) which prohibit people from being free and open.” Elkind, supra at 68. The procedure involves massage, breathing exercises and eye exercises designed to release emotions, repressed since childhood, by releasing the muscles which have been tightened to effect their repression. Thus the eye exercises release tears, and the massage—which often takes the form of violent punching—releases rage. 0. BEAN, supra at 9-13. The goal of the therapy is what Reich called “orgastic potency,” id. at 13, the ability to experience an orgasm “of cosmic proportions.” The Gospel of Orgasm, TIME, May 10, 1971, at 55.
78 ~• MANN, ORGONE, REICH, AND EROS 10, 25-26 (1973); Robinson, Reich
at the Orgone Box, ATLANTIC MONTHLY, Dec. 1972, at 132, 132-36.
~ The “orgone energy accumulator” or “orgone box” was “a closet-size container made of sheet metal and Celotex. It was said to gather ‘orgone energy

1977] RESTRICTIONS
659
against a number of ailments, including cancer.80 He was arrested on charges of misbranding, which he refused to answer on the ground that the FDA injunction was procured by fraud8’ and that the court was not competent to judge the validity of his theories.82 Dr. Reich died after eight months in prison, following a two-year sentence for contempt.8’ A more recent case involved Dr. Herman Taller,84 who was fined $7,000 for marketing safflower oil capsules in conjunction with a theory of weight loss propounded in his bestseller, Calories Don’t Count. The theory was held to be fraudulent by the FDA.85
The source of the FDA’s authority in these cases is its jurisdictional grant of power to regulate foods, drugs, devices or cosmetics traveling in interstate commerce.88 In order to maximize the scope of the agency’s jurisdiction, Congress has broadly defined the term “drug.”87 Further, prior to 1962, the Food, Drug, and

from the cosmos and transmit it, with beneficial psychological effects, to anyone who sat inside.” The Gospel of Orgasm, supra note 77, at 54.
80 o~ B~N, supra note 77, at 23.
81 239 F.2d at 137.
82 Id. at 136.
83 The progression of events following Reich’s arrest are described from the point of view of an adherent, actor Orson Bean:
Instead of hiring a top-notch lawyer and fighting on legal grounds, Reich naively believed that if he simply talked about the importance of his work, justice would prevail in the United States of America. He was sentenced to two years in the Federal penitentiary and it was ordered that all his accumulators and other equipment be destroyed and his books burned. In the summer of 1956, F.D.A. agents entered Reich’s property in Maine and smashed his equipment. They collected his books there and at the publishers in New York and they were burned in the city incinerator. This was twenty years after the Nazi book-burning in Germany.
Following several futile appeals, Reich entered the Federal penitentiary. . . and died there on November 3, 1957.
0. ~ supra note 77, at 24.
84 United States v. Taller, 394 F.2d 435 (2d Cir. 1968).
85 Id. at 436-37. The defendant was convicted of misbranding and mail
fraud. Id. at 437.
8(1 Sec 21 U.S.C. § 331 (Supp. V 1975).
87 The term ‘drug’ means (A) articles recognized in the official United States Pharmacopoeia, official Homeopathic Pharmacopoeia of the United States, or official National Formulary, or any supplement to any of them; and (B) articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals; and (C) articles (other than food) intended to affect the structure or any function of the body of man or other animals. . .
Id. § 321(g)(1) (1970). As noted by the court in United States v. Article of Drug—Ova II, 414 F. Supp. 660 (D.N.J. 1975):
[T]he “official” United States Pharmacopeia (USP), the National Formulary (NF) and the Homeopathic Pharmacopeia (HP) . . . are publications of private organizations, and are not published pursuant to any “authority” other than the right of individuals or organizations to publish such works as they deem appropriate and useful.

The difficulty with any attempt to apply the statutory term “drugs”
as a comprehensive noun for all the chemicals, substances and materials

I

I

Cosmetic Act set only lax standards of safety for new drugs. At that time, the thalidomide tragedy revealed the inadequacy of these procedures; the United States avoided the full impact of the disaster only fortuitously.88 The attention thus focused on drug testing led in 1962 to the Kefauver-Harris Amendments to the Act.89 Included in these provisions is a stringent and mandatory three-phase system of testing and approval, requiring an applicant for approval of a new drug to submit “full reports of investigations which have been made to show whether or not such drug is safe for use and whether such drug is effective in use.”90 Only those drugs shown to be both safe and effective are approved.9’

in the U.S.P. is evident from the fact that a very large number of them have multifarious characteristics, qualities and uses other than the medicinal ones to which the word “drug” naturally applies.
Id. at 667-69. The court pointed out that articles contained in the USP include water, carbon dioxide, nitrogen, oxygen, corn oil, olive oil, lanolin, starch and sucrose (i.e., sugar). Id. at 669-70. However, it is subsection B of the statutory definition which “permits the FDA to brand a food, a supplementary food factor, or a vitamin, a ‘drug,’ and to bring it within the federal capacity of classifying items as ‘new drugs.’” M. CULBERT, VITAMIN B17: FORBIDDEN WEAPON AGAINST CANCER 76-77 (1974).
88 While the present FDA procedures can result in bureaucratic inertia and the suppression of innovative treatment methods, see notes 151-52 & accompanying text infra, historical perspective requires a balancing of these resultant problems against those sought to be avoided by the amendments, illustrated in the following description of the thalidomide investigation:
Although the drug never emerged out of investigational status in the United States, the company distributed such vast supplies as to raise serious doubt as to whether the company was “testing” or promoting the drug. The company sent 2~/2 million tablets to 1,267 investigators .
This supply was so vast as to be capable of causing incalculable harm if the “investigational” drug turned out to be hazardous.

Over and above the peculiar aspects of the “test” already noted, the American company gave additional indications it was not too interested in “investigational” reports. A manual which it issued to its detail men who were to distribute the drug for “investigation” stated .
the main purpose is to establish local studies whose resuits will be spread among hospital staff members. You can assure your doctors that they need not report results if they don’t want to, but that we, naturally, would like to know the results. .

It may be noted that the company’s apparent disinterest in reports
may have contributed to the “investigators’” disinterest in reporting.
Of the 1,267 doctors who received the drug, only 276 gave written
reports to the manufacturers; 102 doctors gave verbal reports. .

Hundreds of “investigators” failed, contrary to the traditions of science, to keep adequate records. They did not know which patient they
had given the drug to, at what dosage or when.
S. REP. No. 1153, 89th Cong., 2d Sess. 22-25 (1966).
89 Drug Amendments of 1962, 21 U.S.C. §§ 321, 331-32, 348, 351-53, 355,
357-60, 372, 374, 376, 381, and notes (1970).
90 Id. § 355.
9’ Id. The method established by the statute for acquiring approval for
a drug is to submit an application (a New Drug Application or NDA) which includes a full report of investigations of the drug’s safety and effectiveness. ld.

F’
r

1977] RESTRICTIONS
661
Since passage of the 1962 Amendments, the issue of physician discretion versus bureaucratic judgment has become more acute. Illustrative California cases stem from the laetrile controversy. California has statutorily forbidden the use of any “drug, medicine, compound or device” to be used in the treatment of cancer which has not received prior FDA or state approval—requiring that it be proven not only safe but effective in combating cancer.92 As a result, three California doctors have recently been arrested for prescribing laetrile93—an apparently harmless94 derivative of apricot pits—as a cancer treatment, a use for which the drug is banned by the California Department of Health.95 The basis for the ban is the drug’s reported failure, in a preliminary test involving forty-four cancer patients, to reduce the size of cancerous tumors.96 Laetrile advocates contend that the proper standard for determining the drug’s effectiveness should be a subjective one, focusing on decreased pain and increased appetite and sense of wellbeing.97 By these criteria, the drug was shown to be effective in all but one of the reported cases in the initial test.98 Because the drug was not shown in the initial test to destroy cancerous

§ 355(b). The agency may refuse an application on grounds that the information submitted is insufficient to establish the drug’s safety and effectiveness. Id. § 355(d). Acting pursuant to this statute, the FDA has promulgated an elaborate set of regulations to govern the testing of new drugs, covering everything from periodic reporting to peer group review to the color of the binder in which an NDA must be submitted. See 21 C.F.R. §§ 310.3 et seq. (1976). The power to refuse to approve an application on grounds that the information submitted is insufficient to establish the drug’s safety and effectiveness is granted in the amended Act. However, the FDA has not made explicit in its published regulations the standards to be applied in determining such insufficiency, introducing the possibility of arbitrary decision by the agency.
92 The sale, offering for sale, holding for sale, delivering, giving away, prescribing or administering of any drug, medicine, compound or device to be used in the diagnosis, treatment, alleviation or cure of cancer is unlawful and prohibited unless (1) an application with respect thereto has been approved under Section 505 of the Federal Food, Drug and Cosmetic Act [21 U.S.C. § 355 (1970)1, or (2) there has been approved an application filed with the [State Board of Public Health] setting forth:
(a) Full reports of investigations which have been made to show whether or not such drug, medicine, compound or device is safe for such use, and whether such drug, medicine, compound or device is effective in such use. .
CAL. HEALTH & Su~Erv CODE § 1707.1 (West 1970).
93 See notes 213-34 & accompanying text infra.
9~ See Rutherford v. United States, 399 F. Supp. 1208, 1214 (W.D. Olda.
1975); Young, The Cancer Drug of Fury, Fear, Hope, L.A. Herald-Examiner, Nov. 16, 1975, § C, at A-2, col. 5.
9~ CAL. ADMIN. CODE tit. 17, § 10400.1(1963).
96 A Report on the Treatment of Cancer with Beta-Cyanogenetic Glucosides (‘Laeriles’) (1963), at 11 (incorporated by reference into CAL. ADMIN. CODE tit. 17, § 10400.1 (1963)).
97 See Brief for Respondent at 29-32, People v. Leslie, Crim. No. CR A
13449 (Cal., Los Angeles Super. Ct. Jan. 26, 1976).
98 Id. at 32-33.

I

tumors, however, the California Department of Health has forbidden its use.99 Here, where a difference of opinion exists among medical experts concerning the standard to be used in evaluating effectiveness, one side is in a position to declare the other position illegal.’00

B. Professional Restrictions

In addition to legal restrictions on the physician’s freedom to treat as he chooses, conformity of treatment is maintained by the profession itself, through its organ, the American Medical Association (AMA).’0’ On the surface, these professional reWhile California’s Department of Health has explicitly prohibited use
of the drug in cancer treatment, the FDA has neither prohibited nor approved its use. Instead, because of “preclinical deficiencies” in the application submitted for its approval for testing, the FDA has revoked its IND (Investigative New Drug) status, Jeaving the federal status of the drug in legal limbo. See Rutherford v. United States, 399 F. Supp. 1208 (W.D. Okla. 1975):
In April 1970 the Food and Drug Administration assigned IND (Investigative New Drug) application 6734 to the McNaughton Foundation, based in California, to test amygdalin-Laetrile, a move which would have given the foundation permission to obtain supplies of the “investigational drug” and to initiate clinical studies. Then, ten days later, permission was suddenly revoked by the FDA, allegedly at the behest of the then surgeon general Jesse Steinfeld, a California physician involved in the California Medical Association ban on the compound in the 1950s. Dr. Charles C. Edwards, FDA commissioner, stated on June 9, 1970:
As with all “cancer” drugs the review of the IND was expedited.
This review was completed on April 27, 1970, 21 days
from the date of receipt. The review disclosed a number of serious
preclinical deficiencies.
On April 28, 1970, a 10-day pretermination notice was issued detailing the deficiencies in the notice, and the sponsor was notified by wire to immediately cease clinical studies. The sponsor was allowed 10 days in which to either request a conference or to correct the deficiencies which were brought to his attention.
Since the sponsor did neither, the IND was terminated on May
12, 1970.
Id. at 1213, quoting M. CULBERT, supra note 87, at 81 (footnotes omitted).
A second commentator adds:
Curiously, . . . the deficiency letter dated April 28, 1970, in Washington, D.C. did not reach McNaughton Foundation until May 6. The
letter gave the Foundation 10 days after receipt to respond.

On May 9 the Foundation wrote FDA to say its full response would be mailed on or before May 16. However, only six days after its receipt by McNaughton, a telegram from FDA stated that the IND number and privilege to test laetrile-amygdalin had been revoked, ostensibly because of lack of response to the delayed letter dated April [28]!
Matchan, High Politics Blamed for Refusal to Test Anti-Cancer Agent, Alameda
Times-Star, July 14, 1970, at 14, col. 1.
100 One of the lactrile defendants noted that if a doctor were to publish his favorable results with the drug, it would constitute proof he had used it and thus provide grounds for his arrest. Richardson, The Doctor’s Dilemma, CANCER CONTROL J., July/Aug. 1974, at 6.
101 In addition to being regulated by the medical practices acts of the various states, the physician is governed by the A.M.A’s “Principles of Medical Ethics.” Frequently, “unethical” practices have been interpre

strictions are enforceable for economic rather than legal reasons. Doctors are dependent on the AMA for malpractice insurance and on each other for referrals.’02 “In a profession where specialists get ninety-nine percent of their patients through referral from other doctors,” as one doctor notes, “a tremendous power exists for disciplining nonconformity.”’03
Though the AMA’s power over the profession is economic, its power is rooted in the laws related to medical licensing.’04 The key to the AMA’s control of professional policy rests in its discretionary accreditation of medical schools and hospitals.’05 To obtain a license, an applicant must be a graduate of an approved school and serve an internship in a state-approved hospital.’06 The lists of approved schools and hospitals of state boards of medical examiners are generally identical with those of the AMA’s Council on Medical Education and Hospitals.’07 In addition to insuring

ted by A.M.A. leadership, and by county medical societies affiliated with the A.M.A., to include such acts as participation in local insurance schemes not approved by organized medicine, association with health practitioners the A.M.A. refers to derogatorily as “cultists” (e.g., osteopaths, chiropractors, and optometrists), and acceptance of salaried arrangements that are not in accord with the A.M.A’s sacrosanct fee-for-service principle.
Rayack, Restrictive Practices of Organized Medicine, 13 ANTrrRUST BULL. 659, 665 (1968).
102 A doctor can ill afford more than a few enemies, certainly not the hostility of an organized group in positions of local prominence. His reputation is a fragile thing, and his income and practice depend upon being called in consultation, though perhaps more vitally on being able to call his colleague in emergencies. Ostracism becomes a terrible weapon in such a business.
Id. at 666-67, quoting 0. GARCEAU, THE POLITICAL LIFE OF THE AMERICAN MEDICAL ASSOCIATION 103 (1941).
103 ANONYMOUS, M.D., ThE HEALERS 197 (1967).
104 Rayack, supra note 101, at 663-65.
105 Id. at 664-65. See Comment, The American Medical Association:
Power, Purpose, and Politics in Organized Medicine, 63 YALE L.J. 938 (1954). All states require that an applicant for medical licensure be a graduate of an acceptable medical school. . . . Since it is impossible for each state board to make an independent inspection of every medical school whose graduates apply for licensure, these boards must rely on an outside agency. The AMA fulfills this need and its list thereby acquires the force of law.
Through their reliance upon the AMA to inspect the nation’s medical schools, the states tacitly confer upon it the power to set the standards for approval. These standards, of course, fix the quality of medical education, but they also indirectly determine the size of classes in each school. Maximum student/faculty or student/cadaver ratios, for example, make expansion costly.
Again, practical considerations require licensing boards to utilize the AMA standards and list of approved hospitals. AMA approval is vital to a hospital; without it, the hospital cannot obtain the low-cost services of interns. This power gives organized medicine a device to enforce conformity with policies occasionally unrelated to medical training.
Id. at 969-70.
106 CAL. BUS. & PROF. CODE § 2192 (West Supp. 1976).
107 Rayack, supra note 101, at 664.
the AMA’s control of professional policy, the power to approve hospitals and schools allows the AMA to restrict the supply of physicians, thereby reducing competition which would otherwise lower fees and increase the availability of medical services.108

III. CRITICAL EVALUATION:
SHOULD THE RESTRICTIONS BE MODIFIED?

The preceding section presents the existing barriers to the practice of unorthodox medical treatment. For the unlicensed, these barriers are licensing laws; for the licensed, they are professional and administrative rules. This section evaluates those restrictions. Policy considerations which have motivated the restrictions are presented, followed by countervailing considerations which have not for the most part been raised before the courts. The restrictions are then evaluated from a constitutional standpoint, balancing the health interest of the state against the right of the individual to choose the treatment he will recelve.

A. Policy Considerations

Regulation of health treatments which are potentially dangerous to the patient—notably those involving surgery or drugs obtainable only by prescription—is universally justified in terms of the state’s interest in protecting the health interest of its citizens.’09 Regulation of health treatments which, though lacking

Twenty-six boards require applicants for licensure to be graduates of schools approved by the Council on Medical Education and Hospitals of the A.M.A. Twenty boards specify the school must be approved by the council and be a member of the Association of American Medical Colleges. In sixteen instances the requirement is specified in the state’s medical practices act; thirty-seven report that it is a formal regulation. Seven licensing boards maintain their own list of approved schools. In actuality, all approved schools are both approved by the council and members of the A.A.M.C.
Id. at n.7. In California, only hospitals approved by the Council on Medical Education of the AMA or the Canadian Medical Association are approved for the training of interns. CAL. ADMIN. CODE tit. 16, § 1342 (1975).
108 Loss of approval by the council would make it extremely difficult for a school’s graduates to obtain licenses. That is why the licensure provision is the key to the effective control of admission. By directly exerting pressure on schools to restrict admissions, or by requiring very high quality standards, the A.M.A. can restrict the supply of physicians and. . . has in fact done so.
E. RAYACK, PROFESSIONAL POWER AND AMERICAN MEDICINE 6 (1967) (footnotes omitted). See also B. EHRENREICH & J. EHRENREICH, supra note 31, at 20; M. FRIEDMAN, CAPITALISM AND FREEDOM 150 (1962) (“The essence of the power of a trade union is its power to restrict the number who may engage in a particular occupation. . . . The American Medical Association is in this position,” id.).
109 See, e.g., People v. Nunn, 46 Cal. 2d 460, 469, 296 P.2d 813, 818 (1956);
Hewitt v. State Bd. of Med. Examiners, 148 Cal. 590, 592, 84 P. 39, 40 (1906);
Blinder v. Division of Narcotic Enforcement, 25 Cal. App. 3d 174, 179-82, 101
Cal. Rptr. 635, 638-41 (1st Dist. 1972).

a record of established effectiveness, are not harmful to the patient must be justified on other grounds. Arguments advanced in support of such restrictions include preventing delay in administering orthodox treatment, protecting a gullible public from fraud, and avoiding economic costs to the patient and to society. The following section will present and evaluate the arguments both for and against such restrictions.

1. Preventing the Delay of Effective Treatment
The strongest policy argument advanced in support of legislation restricting health treatments whose effectiveness has not been established is that ineffective treatments, though harmless in themselves, threaten the public health by delaying effective treatment.’10 Illustrating this argument is the reasoning of the Seventh Circuit in a case concerning health food products marketed for self-treatment by health food advocate Lelord Kordel.”’ In holding that representations concerning the curative properties of certain health food products constituted misbranding and mislabeling under the Food and Drug Act,”2 the court observed:

The danger inherent in this system lies not in any positive unwholesomeness of the articles themselves. As to them as such there is no charge and it may be that they are quite harmless in and of themselves. The danger however, lies in the fact that ignorant and gullible persons are likely to rely upon them instead of seeking professional advice for conditions they are represented to relieve or prevent.”8
The California State Health Department banned laetrile for use against cancer on the same grounds: While finding no danger in use of the drug itself, it saw danger in the possibility that patients would rely on laetrile to the exclusion of conventional therapy.”4 A California court recently upheld the legislature’s proscription of laetrile as a cancer treatment, reasoning as follows:
One desperate for a cure but who seeks to avoid necessary surgery because it is disfiguring, necessary radiation because it is debilitating or necessary chemotherapy because it is toxic, might in his extremity employ substances which are represented to be both harmless and curative. Knowing such propensity of these seriously ill, the Legislature exercised its police power to protect its citizens from the allegedly easier but fallacious cure.”5

110 See, e.g., Quackery, note 13 supra.
~~1 United States v. Kordel, 164 F.2d 913 (7th Cir. 1947).
112 Federal Food, Drug and Cosmetic Act §§ 201(m), 301, 502, 21 U.S.C. §§ 321(m), 352 (1970); id. § 331 (Supp. V 1975).
113 164F.2dat916.
114 CAL. ADMIN. CODE tit. 17, § 10400.1(b) (1975).
“.‘i People v. Privitera, 55 Cal. App. 3d Supp. 39, 52, 128 Cal. Rptr. 151, 159 (Super. Ct. 1976). UCLA LAW REVIEW
[Vol. 24: 647
While this argument is persuasive, its weight is contingent on the actual success of those treatments which are contended to be necessary but disfiguring, debilitating or toxic. It has been authoritatively stated that only fifteen percent of cancers respond well to treatment.’16 Physicians treating cancer patients with laetrile claim the same percentage of objective benefit, along with a much higher percentage of subjective benefit and without painful or disfiguring side effects.”7

Further, since risks are involved in orthodox as well as unorthodox health treatments, arguably in some cases the public health interest is served rather than endangered by delay. Delay would be in the public interest, for example, if the delayed treatment were one of the estimated 12,000 unnecessary operations performed each year which result in death,”8 or if use of an unproven drug were in fact to save a cancerous organ from surgical removal, instances of which are attested to by certain laetrile users. 119

Finally, the argument that unconventional treatment poses the danger of delaying conventional treatment has been countered with evidence that patients turn to unconventional cures only aftef unsuccessful experience with conventional cures.’20

116 Letter from Dean Burk to Congressman Frey, May 30, 1972, reprinted in CANCER CONTROL J., May/June 1973, at 4 (statement of Dr. Frank Rauscher, Jr., Director of the National Cancer Institute). The same source quotes Dr. Charles Moertal, gastrointestinal cancer specialist of the Mayo Clinic:
Our most effective regimens are fraught with risks and side-effects and practical problems, and after this price is paid by all the patients we have treated, only a small fraction are rewarded with a transient period of usually incomplete tumor regressions.
Id. at 5.
“7 Id.
118 Incompetent Surgery Is Found Not Isolated, N.Y. Times, Jan. 27, 1976,
§ 1, at 1, col. 7.
~ See M. CULDERT, supra note 87, at 37-38, 43-45, 75.
120 Thus, a dissenting researcher from the National Cancer Institute noted that of the thousands of cancer patients who had contacted him, all had been treated with conventional methods before seeking laetrile treatment. Letter from Dean Burk, supra note 116, at 4. See also Pressuring the FDA on Laetrile, MEDICAL Woau NEWS, Apr. 9, 1971, at 48M (“[Tihere are some 1,000 [records) extant involving patients who claim benefits from Laetrile after being given no hope from traditional medicine Id.); Lyneis, Cancer Victi,ns Seek Tijuana “Miracle,” The Press (Riverside, Cal.), Apr. 25, 1972, § B, at 2 (quoting a Tijuana physician using Laetrile: “I use it because most of my patients have used other drugs that haven’t worked, and I give them laetrile as an alternative.” ld.). Similarly, in a recent case holding unconstitutional a regulation restricting acupuncture treatment to doctors, the court observed: “Most of [the patients turning to acupuncture treatment] testified that they tried acupuncture as a last resort after having tried and found little or no relief through traditional western medical practices.” Wensel v. Washington, 43 U.S.L.W. 2438, 2439 (0 C. Super. Ct. Apr. 10, 1975).

2. Protecting the Gullible

A second policy consideration underlying regulation of health treatments which are harmless but ineffective is the doctrine of parens patriae.’2’ The state has a duty to protect the ignorant from fraud.122 Characteristic of this paternalistic concern is the assumption that believers in theories and cures not validated by orthodox medical evaluation are deluded; satisfied patrons who swear by the efficacy of unorthodox cures are viewed as symptomatic of the dangerous gullibility of the public rather than of the success of the cures. This assumption is demonstrated in the reasoning of the Iowa Supreme Court in a 1945 case involving a psychic healer charged with practicing medicine without a license.’2’ The complaint came from the Commissioner of Public Health rather than from the healer’s patrons, who were enthusiastic about his success. The court considered the testimony of these patrons concerning cures they believed they had experienced to be evidence for the prosecution rather than for the defense, stating: “The very confidence which [the healer] thus engendered in his patrons is a part of the fraud and imposition against which the statute seeks to protect gullible innocence. “124
Countervailing considerations which may outweigh the goal of insulating a gullible public from fraud are the dangers of infringing on individual liberty’25 and suppressing innova121 Under English law at the time of the settling of the American colonies,
the king had authority to act as “‘the general guardian of all infants, idiots, and lunatics.’” Hawaii v. Standard Oil Co., 405 U.S. 251, 257 (1972), quoting 3 W. BLACKSTONE, COMMENTARIES *47 In Mormon Church v. United States, 136 U.S. 1 (1890), the Supreme Court suggested that the parens patriae power, like the police power, is rooted in the very nature of the state. The parens patriae function can thus be viewed as a power which the members of the community have granted the state for the protection of their future well-being. See J.
RAWLS, A THEORY OF JUSTICE 248-49 (1971).
122 See, e.g., Klinger, Conflict with Quackery, 8 FooD DRUG Cos. L.J. 777,
777-78 (1953). The court in Kordel took this approach, perceiving its role as that of protecting the gullible. United States v. Kordel, 164 F.2d 913 (7th Cir. 1947), discussed at text accompanying notes 111-13 supra.
123 State e~ rel. Bierring v. Robinson, 236 Iowa 752, 19 N.W.2d 214 (1945).
124 Id. at 756, 19 N.W.2d at 216. The opinion continues:

Gullibility could hardly be described in fewer words or illustrated more picturesquely than it is done by the testimony of the witness . . . . E. I. Leighton testified with respect to the treatment for his son Lucius who, it will be recalled, had the tonsils that grew back in next to his jugular vein. “I talked with every doctor in Fort Dodge and every one of them refused to operate. They told him he would bleed to death. . . . He took one treatment from Doc—from Mr. Robinson and felt relieved decidedly. . . . I-Ic took the second treatment and those tonsils disappeared without. . . any assistance from any other doctor.”
Id. at 756-57, 19 N.W.2d at 216-17.
125 The issue of individual freedom versus government regulation is discussed in the context of legislation regulating vitamin supplements by Hon. H. Allen Smith, former California Representative:
The complex history of the Federal Food and Drug Administration’s

3. Standardizing Treatment According to Objective Criteria

A third policy goal underlying regulation of unorthodox health treatments is the development of standardized methods for evaluating treatments, based on objective laboratory findings. This goal stems from the practical consideration that subjective testimony is frequently unreliable. Relegating the evaluation of health treatments to administrative agencies using objective criteria ensures uniformity in the determination of their safety and effectiveness.’28
As with those goals previously considered, the policy goal of objective classification is subject to counterconsiderations. Particularly disputed is the policy of basing regulations on the results of laboratory tests on animals rather than on subjective human findings. The FDA, when confronted with subjective testimony of the efficacy of laetrile, has consistently rejected such testimony in favor of objective laboratory data showing its ineffectiveness on mice.’29 Laetrile proponents object to this standard for determining efficacy on the ground that experiments with mice are ill-adapted to determining long-term effects of slow-acting compounds on humans. They base their contention on the fact that small animals with cancer have shorter life-spans than humans with cancerous conditions.’30
A second objection to the policy of permitting or prohibiting treatments on the basis of uniform objective criteria is that because science is in a state of flux, the criteria themselves are open to dispute.’3’ Laboratory findings are always subject to limitations
128 See, e.g., Weinberger v. Hynson, Westcott & Dunning, 412 U.S. 609 (1973):
Congress surely has great leeway in setting standards for releasing on the public, drugs which may well be miracles or, on the other hand, merely easy money-making schemes through use of fraudulent articles labeled in mysterious scientific dress. The standard of “well-controlled investigations” particularized by the regulations is a protective measure designed to ferret out those drugs for which there is no affirmative, reliable evidence of effectiveness.
Id. at 622.
129 Matchan, supra note 99, at 13-14.
130 ld. at 16. Moreover, authorities differ as to Whether the experimental results on mice were in fact negative. Dean Burk, a National Cancer Institute researcher, stated in testimony quoted in Brief for Respondent, In re Jones, No. D-1509 (Cal., Board of Med. Examiners, Nov. 26, 1975):
Dr. Kanematsu Sugiera is the oldest and most respected researcher in this field in the world and his findings, showing that amygdalin [lactrile] is 78 per cent effective in the control of cancer in mice, are not to be disputed. In the . . . study which was done under the direction of the NCI [National Cancer Institute] the median life expectancy of cancerous mice was extended by forty percent (40%).
ld. at 26.
181 See, e.g., Statement of Hon. Gamer E. Shriver, Representative from
Kansas, Hearings on HR. 643, note 125 supra, in the context of regulating the permitted dosages of over-the-counter vitamin supplements:
There is a serious question that the recommended daily allowances for vitamins and minerals set by the FDA may not be based on fact. Cer

[Vol. 24: 64~

670
UCLA LAW REViEW
of methodology and data interpretation.132 In consequence, critics point out, bureaucratic judgment has been known to be error.”3 Further, “safe” and “effective” are relative rather tha absolute categories, ‘~“ introducing inevitable elements of su~ jectivity and the potential for arbitrary classification.

tainly, there is a wide variation among nutrition experts regarding suggested dosages of vitamin C. For example, Dr. Linus Pauling, winner of a Nobel Prize for chemistry research, recommends a daily dosage of this vitamin at SO times the amount prescribed by the FDA.
Id. at 28. The statement concludes, “But, I believe the most important issB which must be settled, is whether or not we can continue to allow bureaucrat to involve themselves in every single aspect of the daily personal lives of on citizens.” ld.
132 This is as true in the biological/medical sciences as it is in the socia sciences where these limitations have long been recognized. In these sciences, thi variations between observations are not subject to the precise experimental control and refined measurement techniques that are possible in the physical sciences Problems of inductive inference, based on statistical data, can generally never beL eliminated; they can only be confined in scope to whatever level of error is deem~I “significant”—thus triggering further scrutiny. For an elaboration of these types oil biological statistical problems, see generally W. HAYS, STATISTICS FOR PSYCHOLO. GISTS 9-12, 378-84 (1963).
~ For example, vitamin E, which is now considered essential for muscular and reproductive functioning, see, e.g., H. ROSENBERG, THE DocroR BOOK OF VITAMIN THERAPY 129 (1974), was labelled a decade ago by the as unnecessary in human nutrition. P. Amoi..~, supra note 127, at 175. bioflavonoids (vitamin P) were similarly labelled in 1970, in spite of poputt~r protest and extensive European research to the contrary. Id. at 160-65; M. Sla. VERMAN, PILLS, PROFITS, AND POuTICS 123 (1974). Particular dissent has arisen among the public in response to FDA attempts to regulate vitamin supplements, classifying vitamins at strengths greater than 150 percent of the Minimum Daily Requirement as prescription drugs and prohibiting any inference that a particular vitamin or mineral can be helpful in treating or avoiding particular diseases. Hearings on HR. 643, supra note 125, at 26 passim. One objection to the pro. posed regulations is that nutritionists themselves disagree on what dosages are optimum. See note 131 supra.
~ See United States v. Article of Drug—Ova II, 414 F. Supp. 660 (D.N.J. i 1975), holding that a kit for in vitro pregnancy testing is not a “drug” within f the meaning of the Food, Drug and Cosmetic Act, so that proof of its safety and effectiveness before marketing is not required.
[I]n real life it may be doubted whether [the terms “safe” and “effective”] can have any absolute meaning and in most situations, if not all, the terms express relative concepts.
Thus, everyone knows that plain water may be thought of as being safe and effective for the removal of a stain of cherry-colored sugar syrup from fabric. This will be true if the fabric is ordinary cotton, or linen, or polyester and the like. But if the fabric contains a “filler,” or is colored with a water-soluble dye, the use of water may damage the fabric while removing the stain. In those conditions, while effective, the use of plain water will not be safe.

Thus, it is plain that the terms are relative and not absolute and a designation that something is “safe” or “effective” involves collateral questions such as “to whom or what,” and “for what purpose,” and “compared to what”?
Id. at 662. Asserting that “[un terms of the U.S.P. articles, [the “safe and effective”] test is one that is difficult to apply in any rational sense, and in some cases, cannot be applied at all,” the court pointed out:
Many [of the U.S.P. articles] have more than one medicinal use. Some
contain poisons. .
670
UCLA LAW RET/JEW
[Vol. 24: ~

of methodology and data interpretation.’32 In consequence, critics point out, bureaucratic judgment has been known to be error.’33 Further, “safe” and “effective” are relative rather ti absolute categories,’34 introducing inevitable elements of si jectivity and the potential for arbitrary classification.

tainly, there is a wide variation among nutrition experts regarding suggested dosages of vitamin C. For example, Dr. Linus Pauling, winner of a Nobel Prize for chemistry research, recommends a daily dosage of this vitamin at 50 times the amount prescribed by the FDA.
Id. at 28. The statement concludes, “But, I believe the most important is which must be settled, is whether or not we can continue to allow bureauci to involve themselves in every single aspect of the daily personal lives of citizens.” Id.
132 This is as true in the biological/medical sciences as it is in the sol sciences where these limitations have long been recognized. In these sciences, variations between observations are not subject to the precise experimental contt and refined measurement techniques that are possible in the physical scient Problems of inductive inference, based on statistical data, can generally never eliminated; they can only be confined in scope to whatever level of error is deen “significant”—thus triggering further scrutiny. For an elaboration of these types biological statistical problems, see generally W. HAYS, STATISTICS FOR PSYCHOI GISTS 9-12, 378-84 (1963).
~33 For example, vitamin E, which is now considered essential for proj muscular and reproductive functioning, see, e.g., H. ROSENBERG, Tha Docro BOOK OF VITAMIN THERAPY 129 (1974), was labelled a decade ago by the Fl as unnecessary in human nutrition. P. Ataoi~, supra note 127, at 175. 1 bioflavonoids (vitamin P) were similarly labelled in 1970, in spite of popu protest and extensive European research to the contrary. Id. at 160-65; M. S VERMAN, PILLS, PROFITS, AND PoUTICS 123 (1974). Particular dissent has aris among the public in response to FDA attempts to regulate vitamin supplemen classifying vitamins at strengths greater than 150 percent of the Minimum Da Requirement as prescription drugs and prohibiting any inference that a particu vitamin or mineral can be helpful in treating or avoiding particular diseas Hearings on HR. 643, supra note 125, at 26 passim. One objection to the pi posed regulations is that nutritionists themselves disagree on what dosages
optimum. See note 131 supra.
134 See United States v. Article of Drug—Ova II, 414 F. Supp. 660 (D.N
1975), holding that a kit for in vitro pregnancy testing is not a “drug” wit! the meaning of the Food, Drug and Cosmetic Act, so that proof of its safety a effectiveness before marketing is not required.
[I]n real life it may be doubted whether [the terms “safe” and ‘~effective”] can have any absolute meaning and in most situations, if not all, the terms express relative concepts.
Thus, everyone knows that plain water may be thought of as being safe and effective for the removal of a stain of cherry-colored sugar syrup from fabric. This will be true if the fabric is ordinary cotton, or linen, or polyester and the like. But if the fabric contains a “filler,” or is colored with a water-soluble dye, the use of water may damage the fabric while removing the stain. In those conditions, while effective, the use of plain water will not be safe.

Thus, it is plain that the terms are relative and not absolute and a designation that something is “safe” or “effective” involves collateral questions such as “to whom or what,” and “for what purpose,” and “compared to what”?
Id. at 662. Asserting that ‘[i]n terms of the U.S.P. articles, [the “safe and fective”] test is one that is difficult to apply in any rational sense, and in sc cases, cannot be applied at all,” the court pointed out:
Many [of the U.S.P. articles] have more than one medicinal use. Some contain poisons. .
670
UCLA LAW RET/JEW
[Vol. 24: 647

of methodology and data interpretation.’32 In consequence, as critics point out, bureaucratic judgment has been known to be in error.”3 Further, “safe” and “effective” are relative rather than absolute categories,’34 introducing inevitable elements of subjectivity and the potential for arbitrary classification.

tainly, there is a wide variation among nutrition experts regarding suggested dosages of vitamin C. For example, Dr. Linus Pauling, winner of a Nobel Prize for chemistry research, recommends a daily dosage of this vitamin at 50 times the amount prescribed by the FDA.
Id. at 28. The statement concludes, “But, I believe the most important issue which must be settled, is whether or not we can continue to allow bureaucrats to involve themselves in every single aspect of the dally personal lives of our citizens.” Id.
132 This is as true in the biological/medical sciences as it is in the social
sciences where these limitations have long been recognized. In these sciences, the variations between observations are not subject to the precise experimental controls and refined measurement techniques that are possible in the physical sciences. Problems of inductive inference, based on statistical data, can generally never be eliminated; they can only be confined in scope to whatever level of error is deemed “significant”—thus triggering further scrutiny. For an elaboration of these types of biological statistical problems, see generally W. HAYS, STATISTICS FOR PSYCHOLOoIsrS 9-12, 378-84 (1963).
133 For example, vitamin E, which is now considered essential for proper
muscular and reproductive functioning, see, e.g., H. ROSENBERG, THE DocroR’s BOOK OF VITAMIN THERAPY 129 (1974), was labelled a decade ago by the FDA as unnecessary in human nutrition. P. Amo~, supra note 127, at 175. The bioflavonoids (vitamin P) were similarly labelled in 1970, in spite of popular protest and extensive European research to the contrary. ld. at 160-65; M. SILVERMAN, PILLS, PROFITS, AND POLITICS 123 (1974). Particular dissent has arisen among the public in response to FDA attempts to regulate vitamin supplements, classifying vitamins at strengths greater than 150 percent of the Minimum Daily Requirement as prescription drugs and prohibiting any inference that a particular vitamin or mineral can be helpful in treating or avoiding particular diseases. Hearings on HR. 643, supra note 125, at 26 passim. One objection to the proposed regulations is that nutritionists themselves disagree on what dosages are optimum. See note 131 supra.
‘34 See United States v. Article of Drug—Ova II, 414 F. Supp. 660 (D.N.J. 1975), holding that a kit for in vitro pregnancy testing is not a “drug” within the meaning of the Food, Drug and Cosmetic Act, so that proof of its safety and effectiveness before marketing is not required.
[un real life it may be doubted whether [the terms “safe” and “effective”] can have any absolute meaning and in most situations, if not all, the terms express relative concepts.
Thus, everyone knows that plain water may be thought of as being safe and effective for the removal of a stain of cherry-colored sugar syrup from fabric. This will be true if the fabric is ordinary cotton, or linen, or polyester and the like. But if the fabric contains a “filler,” or is colored with a water-soluble dye, the use of water may damage the fabric while removing the stain. In those conditions, while effective, the use of plain water will not be safe.

Thus, it is plain that the terms are relative and not absolute and a designation that something is “safe” or “effective” involves collateral questions such as “to whom or what,” and “for what purpose,” and “compared to what”?
Id. at 662. Asserting that “[i]n terms of the U.S.P. articles, [the “safe and effective”] test is one that is difficult to apply in any rational sense, and in some cases, cannot be applied at all,” the court pointed out:
Many [of the U.S.?. articles] have more than one medicinal use. Some
contain poisons..

1977] RESTRiCTiONS
671
An Oklahoma court, in Rutherford v. United States,”5 which recently assumed equitable jurisdiction to legalize laetrile, pointed out an additional flaw in the FDA requirement of prior bureaucratic approval of treatments: Laypersons lack the means of surmounting the complicated procedural barriers to acquiring such approval.”6 In the case of laetrile, approval for testing the drug had been withdrawn by ‘the FDA as a result of procedural deficiencies in the initial application for Investigational New Drug status,”7 leaving the individual patient without redress.”8 The

Ether . . . is highly effective for general anesthesia, but it is highly volatile, flammable and explosive. And other items may be entirely “safe,” but whether they are “effective” can well depend on the accuracy of the diagnosis, as with some antibiotics, as well as on the condition of the patient’s vital organs.
Id. at 672-73.
“5 399 F. Supp. 1208 (W.D. OkIa. 1975), discussed at notes 235-49 & accompanying text infra.
136 mhe FDA has by its regulations made it impossible for the common man to have an application processed through FDA so that said agency would either approve or disapprove the drug known as laetrile.
mhe plaintiff. . . and those similarly situated are wholly without means
or resources to comply with the provisions of 21 U.S.C. § 355(b)
[(1970)] .
399 F. Supp. at 1212-13. A rule promulgated by the FDA requires submission of the following information about a new drug for which IND status is requested:
a. Chemistry.
i. Chemical structural formula or description for any new-drug substance.
u. Relationship to other chemically or pharmacologically related drugs.
111. Description of dosage form and quantitative composition.
b. Scientific rationale and purpose the drug is to serve.

d. Preclinical studies. (Present all findings including all adverse experiences which may be interpreted as incidental or not drug-related. . .
I. Pharmacology (pharmacodynamics, endocrinology, metabolism,
etc.).
ii. Toxicology and pathology: Acute toxicity studies; subacute and chronic toxicity studies; reproduction and teratology studies; miscellaneous studies.
e. Clinical studies. (All material should refer specifically to each clinical investigator and to the volume and page number in the application and any documents incorporated by reference where the complete data and reports may be found.)
i. Special studies not described elsewhere.
II. Dose-range studies.
lIt. Controlled clinical studies.
iv. Other clinical studies (for example, uncontrolled or incompletely controlled studies).
v. Clinical laboratory studies related to effectiveness.
VI. Clinical laboratory studies related to safety.
VII. Summary of literature and unpublished reports available to the applicant.
21 C.F.R. § 314.1 (1976).
“~ 399 F. Supp. at 1213, quoting M. CULBERT, supra note 87, at 81. See note 99 supra.
138 399 F. Supp. at 1212-13. But see Hanson v. United States, [1976

court found this deprivation of the patient’s right to choose his own treatment to be a taking of life, liberty or property without due process of law.”0

4. Economic Considerations

A final policy goal behind regulating unorthodox health treatments is that of preventing economic ]oss to individuals who patronize practitioners of ineffective treatments. Counterbalancing the economic waste which might result from permitting practitioners of ineffective treatments to continue unregulated, however, are economic costs which result from the elimination of their practice. These costs are attributable to professional monopoly and the suppression of innovative treatments.
a. Professional Monopoly: Doctor Shortage and Price Inflation. The licensing requirement enables organized medicine to restrict the number of physicians in practice.’40 The consequence of this restriction is a doctor shortage, which in turn results in inflated costs.’4’ Many parts of the nation are currently suffering from a doctor shortage,’42 and all parts are experiencing rapidly increasing medical costs.’4’ Greater patient insurance coverage has exacerbated rather than alleviated the problem, by increasing demand while the supply of doctors remains fixed. The result is spiraling inflation.’44 Those who are “too rich for Medicaid, too poor for Blue Cross, and too young for Medicare”’” pay exorbitantly or, along with residents of the nation’s 130 counTransfer Binder] CCH Foon DRUG Cos. L. REP. ~ 38,049 (D. Minn. 1976), which
held inapplicable similar constitutional objections to FDA seizure of laetrile from a “Shaklee” distributing agency, on grounds that the distributor was a seller, not a consumer, of the drug and could afford to comply with the FDA new drug application procedures.
“~ 399 F. Supp. at 1213.
140 See note 108 & accompanying text supra.
141 See E. MCCONNELL, ECONOMICS: PRINCIPLES, PROBLEMS AND POLIcIEs
73 (2ded. 1963).
142 See R. KUNNES, supra note 52, at 11-12 (“Just to bring all parts of the country up to the levels of the vastly understaffed urban areas would require an additional 100,000 MD’s—now [i.e., in 1971],” id.); D. MURRAY, BLUEPRINT FOR HEALTh 46 (1974) (“America… need[s] another 50,000 physicians to approach a good distribution”); see also Health Manpower Bill: Catch is Distribution of Doctors, 188 Sd. 342 (1975) [hereinafter cited as Health Manpower Bill]; A.
GERBER, THE GERBER REPORT 52-53 (1971).
‘“ Total United States spending on health care has increased from $17.3
billion in 1955 to $115 billion in 1975. Between 1970 and 1975, operating-room
charges rose 65 percent, hospital-room charges 57 percent, and physicians’ fees
37 percent. Soaring Cost of Medical Care, U.S. NEWS & WORLD REP., June 16,
1975, at 52. See also The Sky’s the Limit on Health Care Costs, BUS. WEEK,
May 26, 1975, at 72.
144 R. KUNNas, supra note 52, at 84.
145 B. EHRENREICH & J. EHRENREICH, supra note 31, at 5.

ties having no doctors at all,’46 go without. Moreover, the increased workload on doctors decreases the quality of care for patients who do get treatment.’47
By creating a professional monopoly, licensing contributes to both the doctor shortage and the resulting inflated prices.’48 A leading economist argues that medical licensing has in addition diminished the quality of medical practice by reducing the number of physicians, the number of hours physicians can devote to their more important tasks, the incentive for research and development, and the ability of individuals to collect from physicians for malpractice.’49 Analysis by this expert and others’30 suggests that any savings resulting from the inhibition of quackery by licensing are offset by costs created by the licensing itself.

b. Suppression of Innovative Treatments. Paralleling the economic arguments against medical licensing are economic arguments against the suppression of innovative treatments until their effectiveness has been established. One economist has demonstrated statistically that more lives and money are lost than saved by the current stringent FDA standards, under which new drugs are kept off the market until proven not only safe but effective.’5’ In addition to the economic cost of suppressing potentially beneficial drugs for long periods, the testing itself represents a substantial economic cost.’52

146 D. SCHORR, DON’T GET Stc~ IN AMERICA 79 (1970).
147 Doctor Shortage: What Can Be Done, U.S. NEWS & WORLD REP., June
16, 1975, at 66.
148 See W. GELLEORN, INDIVIDUAL FREEDOM AND GOVERNMENTAL RESTItAINTS

(1956):
The thrust of occupational licensing . . . is toward decreasing competition by restricting access to the occupation; toward a definition of occupational prerogatives that will debar others from sharing in them; toward attaching legal consequences to essentially private determinations of what are ethically or economically permissible practices.
Id. at 114.
~ M. FRIEDMAN, supra note 108, at 157-58.
‘~0 See, e.g., id. at 149-60; W. GELLHORN, supra note 148, at 114-18; F. RAYACK, supra note 108, at 7.
~‘ Peltzman, The Benefits and Costs of New Drug Regulation, in REGULATING NEW DRUGS 114 (R. Landau ed. 1973). He summarizes his findings:
Treated as a group, consumers seem clearly to have lost on balance from
the [1962 Kefauver-Harris~ Amendments. Their annual-equivalent gains
and losses break down as follows:
1. Foregone benefits (consumer surplus) due to the reduced flow
of new drugs: a $300-$400 million loss.
2. Reduced waste on purchases of ineffective new drugs: a gain
under $100 million.
3. Higher prices for existing drugs due to reduced competition
from new drugs: a loss of $50 million.
Id. at 207.
152 Id. at 208-09. Peltzman concludes that “too many resources have been devoted to testing of drug safety and efficacy, and, unless at least that part of the

Nor is the cost resulting from the suppression of new treatments merely economic: Innovative alternatives to orthodox treatment represent potential contributions toward improving the public health. The converse of the proposition that some of yesterday’s quackery is today’s science is that some of today’s orthodox practices will be tomorrow’s barbarisms.’53 Because risks to the patient’s health are involved in the orthodox as well as the unorthodox,’54 and because orthodox therapy itself can prove costly, government prohibition of medical alternatives may represent an additional cost in the form of potential benefits forgone or actual harm inflicted.

B. Constitutional Evaluation

If the policy considerations which have traditionally been the impetus behind legislation restricting unorthodox health treatments are weighed against those countervailing considerations which neither the legislature nor the courts have so far recognized, the balance appears to tip away from the traditional considerations. Balancing the costs against the benefits of legislation is, however, traditionally left to the legislature without judicial interference, unless the legislation is found by the courts to infringe on constitutional rights deemed “fundamental,” so that strict judicial scrutiny is warranted.155
Opponents of laws restricting unorthodox health treatments have argued against such laws on the ground that they violate constitutional guarantees of due process and equal protection. Whether

law requiring proof-of-efficacy is rescinded, continued resource waste is inevitable.”
id. See notes 88-91 & accompanying text sup ra.
153 Blood-letting is an ancient example; a modern one is the tonsillectomy, which was performed routinely a generation ago but the need for which is now being questioned. See P. AJROLA, supra note 127, at 175. Disillusionment with radiation and chemotherapy as cancer treatments suggests that they may be the barbarisms of the next generation. See The Myth of Proven Remedies, CANCER CONTROL J., May/June 1973, at 6, 6-7.
‘54 See Bad Prescriptions Kill Thousands a Year, N.Y. Times, Jan. 28, 1976, at 1, col. 6 (an estimated 30,000 Americans die yearly as a direct result of taking drugs prescribed by their doctors); Incompetent Surgery Is Found Not Isolated, N.Y. Times, Jan. 28, 1976, § 1, at 1, col. 6 (more than 250,000 Americans died in 1975 during or immediately after surgery); L. TUSHNET, THE MEDICiNE MEN 194 (1971) (“ ‘Unfortunately, iatrogenic [physician-induced] disease can now take its place almost as an equal alongside the bacteria as an important factor in the pathogenesis of human illness,’” id., quoting D. SPAIN, COMPLICATIONS OF MEDICAL PRACTICE (1963)).
~ Compare Williamson v. Lee Optical Co., 348 U.S. 483 (1955), discussed at note 158 infra, and Varanelli v. Structural Pest Control Bd., I Cal. App. 3d 217, 81 Cal. Rptr. 492 (2d Dist. 1969), discussed at notes 161-62 infra (economic interests), with Griswold v. Connecticut, 381 U.S. 479 (1965), and Roe v. Wade, 410 U.S. 113 (1973), discussed at notes 204-11 & accompanying text infra (fundamental rights).

the courts have concurred has depended on the degree of scrutiny applied,156 which in turn has depended on the nature of the right being infringed.157 Generally courts have validated the restrictions, which have been viewed merely as economic regulation reviewable under a rational basis standard.’58 In order to overthrow legislation restricting practitioners of unorthodox treatments on constitutional grounds, an individual right greater than the state’s well-established power to regulate matters touching upon the public health would have to be found.’59 If the individual right is not deemed fundamental, then the state need only demonstrate the existence of a rational basis for the legislation. If the individual right is found to be fundamental, on the other hand, it can be overridden only upon a showing of a compelling state interest.’60

The following section will evaluate from a constitutional standpoint the legal restrictions on the administration of unorthodox treatments, tracing the interplay between two opposing factors:
those policy considerations which collectively constitute the interest of the state and the constitutional interest in preserving the freedom of the individual.

1. Right to Practice of the Unlicensed Practitioner: Licensing as Economic Regulation

Constitutional challenge to the medical licensing requirement has in the past met with little success. The regulations are considered to involve economic interests rather than fundamental rights,’61 and the constitutional test traditionally applied to economic regulation is the rational basis standard. According to this test, minimal rationality in support of legislation is sufficient to sustain it.’62 In practice, application of this standard has meant

156 See G. GUNThER, CASES AND MATERIALS ON CONSTITUTIONAL LAW 570,

592-95 (9thed. 1975).
‘57 Id.
158 See, e.g., Williamson v. Lee Optical Co., 348 U.S. 483 (1955), in which
the Court upheld an Oklahoma statute which prohibited an optician from supplying a lens or fitting old glasses into new frames without a prescription from a licensed opthomologist or optometrist. The Court stated: “The Oklahoma law may exact a needless, wasteful requirement in many cases. But it is for the legislature, not
the courts, to balance the advantages and the disadvantages of the new requirement.” Id. at 487.
159 See note 109 supra.
160 See Roe v. Wade, 410 U.S. 113, 155 (1973).
161 See, e.g., Varanelli v. Structural Pest Control Bd., 1 Cal. App. 3d 217,
222-25, 81 Cal. Rptr. 492, 496-98 (2d Dist. 1969).
162 [Jiudicial examination of a statute under economic due process attack is completed when any fact or facts appear, or may be hypothesized, which the Legislature might rationally have accepted as the basis for a finding of public interest.
Id. at 222, 81 Cal. Rptr. at 496.

I

that medical licensing provisions which were not entirely rational have nevertheless been given “hands-off’ treatment.’6’
An illustrative case is Oosterveen v. Board of Medical Examiners.”4 The defendant practitioner argued that the California Medical Practice Act unconstitutionally discriminated against naturopaths, who could not practice naturopathy under the Act because naturopathic colleges did not satisfy the statutory licensing requirements.’6’ While recognizing an element of irrationality in the licensing requirement,’66 the court nonetheless upheld the Act.

On the other hand, some precedent exists even under the ordinary rationality standard for c]ose judicial scrutiny of the means chosen to effect the intended ends of medical licensing legislation. In an early case in which the California Supreme Court upheld the licensing exemption for treatment by prayer’67 against charges of unconstitutional discrimination,’68 the court reasoned:
[Tihe degree of knowledge and skill, as well as the character thereof required, depends upon the treatment in the practice of which the practitioner engages. . . . To assume that treatment by prayer is less efficacious or more dangerous or harmfu] to the subject of the prayer by reason of the fact that the supplicant has failed to devote 260 hours to manipulative and mechanical therapy, or has neglected to study elementary bacteriology for a period of 60 hours, does violence to all legal or religious teaching.’69
This reasoning is equally applicable to other forms of unorthodox treatment. Laying on of hands and clairvoyant healing, for example, require no scientific knowledge. Whether they have any scientific effect is subject to dispute. However, the same may be said of treatment by prayer; yet the practice of Christian Science

163 See G. GUNTHER, supra note 156, at 591.
164 112 Cal. App. 2d 201, 246 P.2d 136 (2d Dist. 1952).
163 Id. at 202, 246 P.2d at 138.
166 lt is somewhat difficult to understand why one who has received the same education in the basic sciences in a naturopathic college as a student of chiropractic would receive in a chiropractic college, should be required to pursue further study in chiropractic in order to obtain a license under which he would be privileged to employ drugless healing methods without resorting to manipulation of the joints. But this was a matter for the Legislature . .
ld. at 207-08, 246 P.2d at 141 (emphasis added).
107 The current version of the prayer exemption is found in CAL. BUS. & PROF. CODE § 2146 (West 1974):
Nothing in this chapter shall be construed so as to discriminate against any particular school of medicine or surgery, school of j~odiatry, or any other treatment, nor shall it regulate, prohibit or apply to any kind of treatment by prayer, nor interfere in any way with the practice of religion.
Id.

treatment by the unlicensed is not only legal but legally chargeable to insurance coverage.170
Following this line of reasoning,”’ it can be argued that the training requirements of the Medical Practice Act are not rationally related to the practices for which unorthodox practitioners are seeking to be licensed, making the Act overly broad. A properly tailored statute would limit the definition of practicing medicine to the popular understanding of the phrase.”2 As the law now stands, however, it is unlikely that this tailoring will be effected by courts using an ordinary rationality test, under which licensing remalns essentially a matter of legislative discretion.

2. Restrictions on Unlicensed Practitioners Under the Means Scrutiny Standard

Recent precedent does exist, however, for closer judicial scrutiny of the rationality of licensing legislation. In this decade the Supreme Court has evinced a new willingness to strike down economic legislation on rational basis grounds, through a “modestly interventionist,””’ means-oriented due process test. This test, though less rigorous than the strict scrutiny applied to legislation involving fundamental rights, is nevertheless stringent enough to strike down legislation which is not reasonably calculated to accomplish its intended ends, whether or not there exist facts which the legislature might rationally have accepted in its sup
~ Under this test, the ordinary rationality requirement— that the means be rationally related to the ends—is given “new bite”: Means, though plausible, which do not in fact substantially further legislative ends are rejected.”3

170 John, Recognition oj Christian Science Treatment, 1963 INs. L.J. 18, 20-
21.
171 Using People v. Jordan as precedent, however, poses a problem: It was decided during the interventionist era of Lochner v. New York, 198 U.S. 45 (1905), discredited in the 1930’s, after which the precedent was established of judicial deference to the legislative judgment where the regulation at issue is an economic one. See G. GUNTHER, supra note 156, at 548.
172 See notes 257-60 & accompanying text infra; G. GUNTHER, supra note
156, at 981.
173 Gunther, The Supreme Court, 1971 Term—Foreword: In Search of Evolving Doctrine on a Changing Court—A Model for a Newer Equal Protection, 86 Hutv. L. REV. 1,44 (1972).
174 For a discussion of this test, see id.
I 7~ id. at 20. Gunther traces the test’s development through seven recent Supreme Court cases, noting that in each,
the Court was less willing to strain for conceivable justifications, less ready to hypothesize imaginable facts that might underlie questionable classifications, less inclined to tolerate substantial over- and under-inclusiveness in deference to legislative flexibility.
id. at 33 (emphasis added). The cases are James v. Strange, 407 U.S. 128 (1972); Jackson v. Indiana, 406 U.S. 715 (1972); Weber v. Aetna Cas. & Sur.

Prior to the 1970’s, regulation of the health field, like that of business, “evoked the most extreme judicial deference.””8 But at least two recent cases in which the means-oriented test has been applied raise the possibility of a change in judicial posture toward health legislation.

In Eisenstadt v. Baird,”’ a 1972 case involving legislation banning the sale of contraceptives, the Supreme Court refused to maintain its deferential stance toward the legislation though the state’s interest in protecting the public health was asserted in its defense.”8 The Court instead applied a means scrutiny test to the statute, with the result that the statute was found to be “overbroad” for achieving its public health purpose.”9

A second recent case applied a means scrutiny analysis specifically to medical licensing, holding that a District of Columbia regulation restricting the practice of acupuncture to licensed physicians and dentists unconstitutionally infringed the right of physicians to prescribe and of patients to receive medical treatment.’80 The court stated:
While such rights may not be “fundamental rights,” the interests involved nevertheless are of such magnitude that this court will carefully examine the record to determine whether the regulation impermissibly stifles significant personal liberties.’8’
Like the Supreme Court in Eisenstadt v. Baird, the District of Columbia court showed a reluctance to further expand “the amorphous right of privacy of Griswold v. Connecticut”’82 in order to apply strict scrutiny.’8’ However, “carefully examine”

Co., 406 U.S. 164 (1972); Stanley v. Illinois, 405 U.S. 645 (1972); Humphrey v. Cady, 405 U.S. 504 (1972); Eisenstadt v. Baird, 405 U.S. 438 (1972); Reed v. Reed, 404 U.S. 71(1971).
176 Gunther, supra note 173, at 32.
1(7 405 U.S. 438 (1972).
178 See Gunther, supra note 173, at 32.
179 Justice Brennan [speaking for the majority in Eisensadt v. Baird] noted, for example, that “not all contraceptives are potentially dangerous,” and that this made the inclusion of all contraceptives in the statute “overbroad” if one viewed the legislation as a health measure.
Moreover, he, unlike a deferential Court searching for conceivable justifications, took no notice at all of the possible health interest in assuring adequate professional advice regarding the relative effectiveness of contraceptives.
Id. (footnote omitted).
180 Wensel v. Washington, 43 U.S.L.W. 2438 (D.C. Super. Ct. Apr. 10,
1975). See note l20supra.
181 43 U.S.L.W. at 2438.
182 Gunther, supra note 173, at 29. See notes 204-07 & accompanying text in Ira.
183 Gunther asserts that means scrutiny is used as an avoidance technique,
in order to give intensified scrutiny to statutes without increasing the suspect
category list prerequisite to evoking “strict” scrutiny. Gunther, supra note 173,
at 30.

seems nearly synonymous with “strictly scrutinize.” And the results of applying the “carefully examine” test parallel those of strict scrutiny. Upon careful examination, the court found that the means did not in fact serve the health interest which was their purported end. Rather, the regulation irrationally authorized the practice of acupuncture by those not trained in its techniques, while prohibiting the practice by masters of the art.’84

Under a means-oriented test, then, the focus is on the real, not the hypothetical, reasons behind legislation.’8’ Applying this approach to the Medical Practice Act, it may be observed that while the asserted state purpose behind medical licensing laws is to “safeguard the public health and welfare . . . rather than to protect physicians themselves,”’86 the impetus for licensing comes, not from the public, but from the profession itself.’8’ The AMA lobby is the best financed in the country;’88 in contrast, the public interest is “widely dispersed.”’89 In consequence, legislatures often tend to be influenced more by the special interest of the profession than by the unorganized consumer interest.’90 It has been

184 In fact, on this entire record, the incidence of actual serious medical complications arising from acupuncture therapy is insufficient to warrant a finding of an actual health hazard posed by the modality of acupuncture therapy itself. The difficulty with the regulation is that it
seeks to remedy a danger that has not been shown to exist by means that are not rationally related to such a purpose. . . . Purportedly enacted in the interests of protecting public health, the regulation ironically authorizes any physician or dentist to administer acupuncture treatments notwithstanding their total lack of any practical or theoretical knowledge as to the art.
43 U.S.L.W. at 2439.
185 Gunther, supra note 173, at 21.
186 70 C.J.S. Physicians and Surgeons § 3 (1975),
277 N.Y. 368, 374, 14 N.E.2d 439, 441 (1938).
187 M. FRIEDMAN, supra note 108, at 140.
188 R. KUNNES, supra note 52, at 60.
189 M. FRIEDMAN, supra note 108, at 143.
190 Id. See also Senator E. Kennedy, Introduction
citing People v. Laman,

to D. SCHORR, note 146
lupra:
[Tihe vested interests are strongly ranged against innovation, and there is no champion capable of marshaling the diffuse advocates for progress and reform. . . . When a new and more efficient development is offered and threatens the status quo in health . . . we know there will be opposition from organized medicine, but there is seldom organized advocacy by health consumers.
Id. at 8. See also Health Manpower Bill, note 142 supra, also quoting Senator E. Kennedy:
Tco often the lobbying effort by the national academic medical centers is indistinguishable from that of any other vested interest groups—that 15, for the status quo and vigorously opposed even to serious discussion of potential reforms. In the absence of a constructive dialogue between Congress and academic medicine we in the Congress, with the best of intentions, may do the wrong things.
Id. at 343. Concerning the lack of organized consumer advocacy with respect to drug regulation reform, see Peltzman, note 151 supra:
The most important group that has been hurt [by the Kefauver-Harris Amendmentsl, that is drug consumers, cannot be expected to offer sub-

persuasively argued that a moderately interventionist judicial scrutiny of means could offset this bias.’9’ Application of a means scrutiny test to the medical licensing laws might accordingly result in their reform on grounds not only of overbreadth but of a cost/benefit analysis in which the costs outweighed the benefits.’92

3. Constitutional Challenge on Grounds of Violation of a Fundamental Right

A constitutional interest which affords stronger grounds for relaxing restrictions on unorthodox treatments than the right of the practitioner to practice his trade is the right of the patient to choose his own treatment. The difference, from a constitutional standpoint, is that while the right of the practitioner to practice his trade is an economic interest which may be overridden by a state interest which is merely rational, the right of the patient to choose his own treatment is a fundamental one which may be overridden only by a state interest which is “compelling.”’9’ The following section will trace the development of the right of the patient to choose his own treatment, and the correlative right of the physician to administer the chosen treatment,’94 from prestantial pressure for change. The damage to each member of this vast
group can be no more than a few dollars per year, so that members of this group have little incentive to bear the costs of organizing politically.
Id. at 208.
191 See Gunther, note 173 supra:
Means scrutiny . . . can improve the quality of the political process— without second-guessing the substantive validity of its results—by encouraging a fuller airing in the political arena of the grounds for legislative action. Examination of means in light of asserted state purposes would directly promote public consideration of the benefits assertedly sought by the proposed legislation; indirectly, it would stimulate fuller political examination, in relation to those benefits, of the costs that would be incurred if the proposed means were adopted.
Id. at 44.
192 Id.

‘93 Compare, e.g., Varanelli v. Structural Pest Control Bd., I Cal. App. 3d 217, 222-25, 81 Cal. Rptr. 492, 496-98 (2d Dist. 1969), quoted in note 162 supra, with, e.g., Roe v. Wade, 410 U.S. 113, 152-55 (1973).
194 The fundamental right of the patient to select his treatment extends to the practitioner: Deriving from the right of the patient is the practitioner’s right to administer the treatment requested by his patient. The practitioner’s right thus becomes, by derivation from the patient’s, a fundamental one which can also be overridden only by a state interest which is compelling. See, e.g., Roe v.
Wade, 410 U.S. 113 (1973):
[Flor the period of pregnancy prior to this “compelling” point [the second trimester], the attending physician, in consultation with his patient, is free to determine, without regulation by the State, that in his medical judgment, the patient’s pregnancy should be terminated.
Id. at 163. See also the companion case, Doe v. Bolton, 410 U.S. 179 (1973), in which the Court invalidated restrictions imposed by the Georgia abortion

constitutional cases through Roe v. Wade’95 to the current laetrile controversy.

a. Choice of Treatment: Nature and Development of the Right. Both federal and state opinions support the premise that the final decision among alternative medical treatments—or between treatment and no treatment—belongs to the treated. Where the choice is between alternative legal treatments, the Constitution is not even invoked; the right is considered “axiomatic.”’90 “Every human being of adult years and sound mind,” said Cardozo, “has a right to determine what shall be done with his own body . ~“ 197 The right to choose a suicidal faith cure has been established, as well as the right to refuse treatment.’98 In one case, a New York court’99 refused an application for a court order to give a blood transfusion to an unwilling Jehovah’s Witness in the face of official pronouncement that he risked death without it. The court stated:
[I]t is always a question of judgment whether the medical decision is correct. . . . [Tihe Court concludes that it is the individual who is the subject of a medical decision who has the final say and that this must necessarily be so in a system of government which gives the greatest possible protection to the individual in the furtherance of his own desires.200

And in 1972, while holding in Cobbs v. Grant20’ that a physician would be guilty of malpractice who had failed to inform a patient on whom he had operated of the attendant risks of and available alternatives to the operation,’02 the California Supreme Court accorded the patient the final choice among medical alternatives,

statute on the physician’s right to perform an abortion, leaving only a bare reference to the physician’s “best clinical judgment.” Id. at 183, 191.
195 410 U.S. 113 (1973).
196 See, e.g., Cobbs v. Grant, 8 Cal. 3d 229, 242, 502 P.2d 1, 9, 104 Cal. Rptr. 505, 513 (1972).
‘9’ Schloendorff v. New York Hosp., 211 N.Y. 125, 129, 105 N.E. 92, 93 (1914), overruled on other grounds in Bing v. Thunig, 2 N.Y.2d 656, 665,
143 N.E.2d 3, 8, 103 N.Y.S.2d 3, 10 (1957).
198 See Cawley, Criminal Liability in Faith Healing, 39 MINN. L. REv. 48,
69 (1954). See also Chief Justice Burger’s dissent in Application of President & Di-ectors, 331 F.2d 1010, 1017 (D.C. Cir. 1964) (Burger, C.J., dissenting). Referring to Justice Brandeis’ “right to be let alone” philosophy, expounded in Olin-stead v. United States, 277 U.s. 438, 478 (1928), Chief Justice Burger states: “I suggest he intended to include a great many foolish, unreasonable and even absurd ideas which do not conform, such as refusing medical treatment even at great risk.” 331 F.2d at 1017.
199 Erickson v. Dilgard, 44 Misc. 2d 27, 252 N.Y.S.2d 705 (Sup. Ct. 1962).
200 Id. at 28, 252 N.Y.S.2d at 706.
201 8 Cal. 3d 229, 502 P.2d 1,104 Cal. Rptr. 505 (1972).
202 Id. at 243, 502 P.2d at 10, 104 Cal. Rptr. at 514. On informed

consent, see also Putensen v. Clay Adams, Inc., 12 Cal. App. 3d 1062, 1083-84,
91 Cal. Rptr. 319, 332-34 (1st Dist. 1970); Berkey v. Anderson, 1 Cal. App. 3d
790, 803-04, 82 Cal. Rptr. 67, 76-77 (2d Dist. 1969); Salgo v. Board of Trustees,
154 Cal. App. 2d 560, 578, 317 P.2d 170, 181 (1st Dist. 1957).

following such full disclosure.205
It might be argued that the right established in Cobbs v. Grant applies only to a choice among legalized medical alternatives. However, recent United States Supreme Court decisions making privacy a fundamental right suggest that in some cases the individual’s right extends to treatments which are statutorily forbidden. In these cases, in which an individual right conflicts with a state interest, the individual right has been elevated to constitutional status. In the landmark case of Griswold v. Connecticut,204 the United States Supreme Court found the public interest purportedly served by regulations banning the use of contraceptives outweighed by the individual’s right to determine for himself whether or not to use birth control methods.205 The individual’s right, subsumed under the penumbral right of privacy, was classified as a fundamental one meriting strict scrutiny.’06 The right having been found to be “created by . . . fundamental constitutional guarantees,” the law restricting it was invalidated as “sweep[ing] unnecessarily broadly and thereby invad[ingl the area of protected freedoms.”20’ Griswold, in turn, served as precedent for Roe v. Wade,205 in which the Supreme Court granted a woman the right to what was until that time a criminal abortion. 209 The Court held that a pregnant woman’s right to determine whether or not she would bear a child was a fundamental one outweighing the state’s health interest in unborn life.210 Here, as in Griswold, recognition of the right as fundamental resulted in abrogation of the law rather than of the right—up to the point at which the state’s health interest became “compelling” at the second trimester of pregnancy.21’
These cases can be read as establishing the right of the individual, acting on the advice of a physician, to determine the

203 8 Cal. 3d at 243, 502 P.2d at 10, 104 Cal. Rptr. at 514.
204 381 U.S. 479 (1965).
205 Id. at 485.
206 Id. at 481-85 (fundamental right), 503-04 (White, J., concurring) (necessity of applying strict scrutiny).
207 id. at 485, quoting NAACP v. Alabama, 377 U.S. 288, 307 (1964).
208 410 U.S. 113 (1973). See also the companion case, Doe v. Bolton, 410 U.S. 179 (1973), discussed at note 194 supra.
209 410 U.S. at 117-18.
210 Id. at 162-65. But see Bowland v. Municipal Ct., 45 U.S.L.W. 2293 (Cal. Sup. Ct. Dec. 6, 1976), holding that California’s statutory prohibition against the unlicensed practice of midwifery did not violate the mother’s constitutional right of privacy. The Bowland court noted:
[Tihe right of privacy has never been interpreted so broadly as to protect a woman’s choice of the manner and circumstances in which her baby is born. . . . In Roe, the Supreme Court held expressly that the state may proscribe the performance of an abortion . . . by a person who is not a licensed physician.
Id. at 2293.
211 410 U.S. at 162-63.

treatment he or she will receive as a fundamental one which can only be overridden by a state interest which is compelling. However, it remained for subsequent cases to define what a “compelling” state interest was. It may be inferred from subsequent holdings that the tendency to find such an interest has depended on two factors: the potential danger to the patient of allowing the treatment, and the consensus of medical 212 against the treatment.
b. Choice of Treatment as a Fundamental Right: The Laetrile Controversy. Following Griswold and Roe v. Wade, constitutional challenge to legislative restrictions on physician! patient discretion has been attempted in a number of cases involving the right to administer and use laetrile in the treatment of cancer. Until recently, the challenge has met with little success; current developments, however, indicate a reversal of this trend.
(1) California Laetrile Cases Brought Against Physicians. Constitutional challenge to the state ban on laetrile has been brought in cases involving three California doctors administering the drug to cancer victims.213 The basis of the constitutional claim was violation of a fundamental privacy right to choice of treatment, the physician’s right being derived, as in Roe v. Wade, from that of the patient. The doctors were each charged with violation of that section of the California Health and Safety Code which forbids prescribing or administering any drug or device “to be used in the diagnosis, treatment, alleviation or cure of cancer” which has not been approved by the FDA as safe and effective for that purpose.214 In each case the defense argued that the section constituted an invasion of the doctor’s constitutional right, enunciated in the recent abortion and birth control decisions, to treat the patient as
212 See, e.g., Hanson v. United States, [1976 Transfer Binder] CCH FooD DRUG Cos. L. REP. ~ 38,049 (D. Minn.), in which the court, though presented with “a blizzard of promotional materials, pamphlets, books, and articles urging the curative effects of lactrile,” concluded that
the plaintiffs still fail to advance their cause, for the Court cannot find a single document claiming that laetrile tablets and vials are generally recognized as safe and effective for the treatment of cancer by experts in this country. Indeed, plaintiff Schuster implicitly conceded that this burden cannot be met.
Id. at 38,163-64 (emphasis in original).
213 People v. Richardson, Crim. No. 41953-C (Cal., Berkeley-Albany Mun.
Ct. May 8, 1974); In re Jones, No. D-1509 (Cal., Board of Med. Examiners
Nov. 26, 1975); People v. Turner, Crim. No. CR-32978 (Cal., San Diego Super.
Ct. Feb. 2, 1976); People v. Leslie, Crim. No. CR A 13449 (Cal., Los Angeles
Super. Ct. Jan. 26, 1976), rev’g People v. Leslie, Crim. No. M 113068 (Cal.,
Citrus Mun. Ct. Apr. 1975). Leslie and Turner involve a single doctor, James
R. Privitera of Covina.
214 CAL. HEALTH & SAFETY CODE § 1707.1 (West 1970) (originally enacted
1967). See Real Issue Is Nutrition and Doctor-Patient Relationship, 21 NAT’L
HEALTH FED’N BULL., July/Aug. 1975, at 26 [hereinafter cited as Real Issue Is
Nutrition].

he believes necessary.2’5 In all, however, the courts failed to recognize the argument, reaching their decisions instead on other grounds.
Conviction of the physician in the first case- was reversed on grounds that appellants were denied their right to trial by jury and that proof was lacking of an essential element of the offense— namely, that laetrile was administered “in the diagnosis, treatment, alleviation or cure of cancer.” The court failed, however, to look into the constitutional argument.217
The second case involved a physician who had administered laetrile to a hospitalized cancer patient at her request. The hospital ordered the physician to cease, after which the State Medical Board filed suit against the physician218 and the patient’s husband filed suit against the hospital.219 The suit against the physician resulted in his probation, on grounds not of violating the statute but of violating a section of the California Administrative Code
“20 suit
which forbids using laetrile for any purpose.- The against the hospital resulted in a denial by the court of the plaintiff’s request for a temporary restraining order.22’ The case thereafter became a class action suit, the original plaintiff having been joined by 170 other cancer victims determined to rely on laetrile

215 Real Issue Is Nutrition, note 214 supra. See, e.g., Brief for Respondent at 16-17, People v. Leslie, Crim. No. CR A 13449 (Cal., Los Angeles Super. Ct. Jan. 26, 1976):
mhe Court found that “those trained in the respective disciplines of medicine, philosophy, and theology are unable to arrive at any consensus” concerning when the fetus must be judged a life-in-being, by reason of which it held that:
“In view of all this, we do not agree that, by adopting one theory of life, Texas may override the rights of the pregnant woman that are at stake.”
Thus, so long as there is not a consensus among medical experts, it is the patient, and not the State, that has the right to elect between the various remedial procedures that may be available.
Id. at 16-17, quoting Roe v. Wade, 410 U.S. 113 (1973) (citations omitted) (emphasis added by respondent).
218 People v. Richardson, Crim. No. 41953-C (Cal., Berkeley-Albany Mun.
Ct. May 8, 1974).
217 See Albany Laetrile Ruling Reversed, Berkeley Daily Gazette, June 14,
1974, reprinted in CANCER CONTROL J., July/Aug. 1973, at 34. The case was sent back to the lower court for a jury trial, which resulted, in November 1973, in a mistrial, with the jury not able to unanimously agree on a verdict. The case was then tried for a third time, resulting in a hung jury and dismissal on May 8, 1974. Culbert, Laetrile: Hung Jury, a New Trial Possible, Berkeley Daily Gazette, May 9, 1974, reprinted in CANCER CONTROL J., July/Aug. 1974, at 8-9.
218 In re Jones, No. D-1509 (Cal., Board of Med. Examiners, Nov. 26,
1975), discussed in Matchan, The Laetrile Trip: From Science to Medico-Politics, CANCER CONTROL J., Sept/Oct. 1974, at 13, 20.
219 Bergman v. Stanford, brought in Santa Clara County Superior Court, discussed in Matchan, supra note 218, at 20-21.
220 CAL. ADMIN. CoDE tit. 17, § 10400.1 (1963). Personal communication from George W. Kell, attorney for defendant, to author, on Aug. 25, 1976.
221 Matchan, supra note 218, at 20.

treatment.222 The litigation, however, is currently stalled due to insufficient funding.223
Dismissal of the charges on constitutional grounds in a suit against the third physician arrested for using laetrile was reversed on appeal.224 The appellate court acknowledged the argument that physician and patient had a constitutional right of privacy which included, respectively, the prescribing and taking of “any drug . . . on the market,”223 and that this right could be overridden only by a compelling state interest.226 It found by implication, however, that the regulation of cancer treatments was in fact a compelling state interest. It distinguished Roe v. Wade as follows:
[Tihe court in Roe v. Wade was concerned with the attempt of the state to protect the public from medical procedures (abortion) that are not more hazardous to the patient than the alternative of normal pregnancy. However, the California Legislature, in enacting the statutory scheme of cancer regulations, made the implicit finding that alleged but ineffective cancer remedies are more hazardous to the patient than the state-sanctioned alternatives.22’
The court’s ground for finding a greater hazard in unproven than in state-approved remedies was based on the argument, discussed earlier, that trying the unsanctioned delays the sanctioned.228
In addition to this suit, the same physician faced charges brought by United States Customs Officials in San Diego Superior Court.229 In overruling a demurrer in the latter suit, the court upheld the defendant’s right to give laetrile to his patients. At the same time, it denied the defendant’s argument that the statute he was charged with violating230 constituted an invasion of the fundamental right of privacy of the physician and his patient. The court’s reasoning was that the statute proscribed only unapproved

222 See Cancer Patients Seeking Drug Use, CANCER CONTROL 3., July/Aug.
1974, at 8.
223 Private correspondence from plaintiffs’ attorney, George W. Kell, of Modesto, Cal., to author, Oct. 15, 1975. Attorney Kell is counsel in another class action, Ode gaard v. California State Dep’t of Health, involving 74 cancer patients who are suing San Diego County Superior Court Judge Roy Fitzgerald for barring Dr. Privitera from treating them with laetrile. See notes 224-34 & accompanying text infra. The suit was filed in federal court in San Diego, on Feb. 18, 1976. Laetrile Judge Sued, L.A. Herald-Examiner, Feb. 19, 1976, at A-2, col. 1, and personal communication from Kell, Mar. 19, 1976.
224 People v. Privitera, 55 Cal. App. 3d Supp. 39, 128 Cal. Rptr. 151 (Super. Ct. 1976).
225 Id. at 51, 128 Cal. Rptr. at 158.
226 Id.

227 Id. at 52, 128 Cal. Rptr. at 159.
228 See text accompanying note 115 supra.
229 People v. Turner, Crim. No. CR-32978 (Cal., San Diego Super. Ct. Feb. 2, 1976).
230 CAL. HEALTH & SAFETY CODE § 1707.1 (West 1970).

substances when used as cancer treatments, in the regulation of which the state has a compelling interest.23’ Administrative approval, the court held, was not required for the use of substances for general nutritional purposes only.232 This ruling was considered a landmark by laetrile advocates, since it allowed use of laetrile so long as no unproven claims were made for it. The court managed, however, to permit the drug’s use while refraining from stating that a physician could prescribe according to his best professional judgment if it diverged from the FDA’s. Moreover, the suit resulted in conviction for the defendant, on the ground that he was in fact selling laetrile as a cancer cure.23’ The decision is currently on appeal in the Court of Appeals for the Ninth Circuit.28’
(2) Subsequent Developments in Other States. Challenge to FDA failure to approve laetrile for use in the treatment of cancer met with greater success, however, in other states. In Oklahoma, a district court ruled it had jurisdiction to permit the drug’s use, because the FDA had abdicated jurisdiction by failing to either approve or disapprove the drug.235 The decision focused on the right of the patient to receive laetriie treatment without referring to the right of the physician to administer it. In Alaska, the Legislature went further, passing a bill explicitly prohibiting interference with a physician’s administration of the drug.236
231 Decision and Order Overruling Demurrer at 4-5, People v. Turner, Crim. No. CR-32978 (Cal., San Diego Super. Ct. Feb. 2, 1976).
232 [Aln individual (doctor) administering nutrients, vita,n ins or other substances, contributing to the total health of a cancer patient, rather than the malignant neoplasm, would not be in violation of Section 1707.1. . . . [W]hat Section 1707.1 prohibits, is the sale, holding for sale, delivering, giving away, prescribing, or administering any drug, medicine, compound or device with the intent that it be used in the diagnosis, treatment, alleviation or cure of cancer per se (malignant neoplasm) where such drug, etc., has not been approved for this purpose as required by Section 1707.1. . . . A doctor who wishes to prescribe Laetrile . . . to his patient who happens to be a cancer 1’icti,fl, may do so a~ long as his intention is to treat the patient’s general health . . . . Section 1707.1, so defined, . . . does not unreasonably violate the constitutionally protected right of privacy between doclor and patient. Any impingement upon this right is outweighed by the overriding compelling interest of the State in regulating and prohibiting scientifically untested and unproven cancer drugs.
Id. (emphasis in original).
238 See L.A. Times, Dec. 18, 1975, § 1, at 2, col. 5.
234 Personal communication from Don Canning, Office of the Dist. Att’y, San Diego, to author, Aug. 1975.
235 Rutherford v. United States, 399 F. Supp. 1208 (W.D. OkIa. 1975).
236 Act of Sept. 19, 1976, ch. 227, [1976] Alaska Sess. Laws. The Act

provides:
Section 1. No hospital or health facility may interfere with the physician-patient relationship by restricting or forbidding the use of amygdalin (laetrile) when prescribed or administered by a physician and requested by a patient unless the substance as prescribed or adminlstered by the physician is found to be harmful by the State Medical Board in a hearing conducted under the provisions of the Administrative Procedure Act (AS 44.62).
[Section] 2. No physician may be subject to disciplinary action by

1977] RESTRICTiONS
687
The Oklahoma suit was a class action brought on behalf of cancer victims. The named plaintiff was a patient who, according to the evidence, had been pronounced by orthodox medicine to have a cancer requiring surgery, possibly involving removal of the rectum.2” The plaintiff became upset by this prospect and failed to report for surgery. He went instead to a clinic in Mexico, where he was given daily laetrile treatments for a period of weeks.238 The court stated that it “was compelled to find from the testimony and the exhibits that [the] plaintiff . . . was in late 1971 suffering from invasive adenocarcinoma and that by the use of laetrile
his condition was cured 239 The patient felt, however, that the continued dormancy of his cancer depended on the continuation of laetrile treatment, which had been made impossible by the jailing of the carrier who had supplied him with the drug.240 The patient therefore brought suit to enjoin the FDA “from precluding the administration of vitamin B17 or laetrile to patients in the United States suffering from cancer.”24’ The court cited Roe v. Wade242 in support of its finding that “for the plaintiff . . . and those similarly situated to be denied the freedom of choice for treatment by laetrile to alleviate or cure their cancer, was and is a deprivation of life, liberty, or property without due process of law
“243 The court noted that the crux of the plaintiffs dilemma, and the justification for the court’s holding, was inaction by the FDA; if the agency had actually disapproved the drug, the plaintiff could have appealed the ruling to the courts.244 Instead, the agency
Id.
the State Medical Board for prescribing or administering amygdalin (lactrile) to a patient under his care who has requested the substance unless the State Medical Board in a hearing conducted under the Administrative Procedure Act (AS 44.62) has made a formal finding that the substance is harmful.
237 399 F. Supp. at 1210-11.
238 Id. at 1211.
239 id.
240 For his efforts, the carrier faced a $10,000 fine and five-year prison sentence—the maximum penalty imposed for smuggling an illegal drug intended for resale in the United States. See 18 U.S.C. § 545 (1970). That only the supplier, not the possessor, of laetrile is subject to criminal prosecution is due to the fact that the drug is not classified as a “controlled” substance—like heroin or marijuana—the possession of which is illegal. However, because the FDA has not officially recognized the drug as “safe,” it cannot be brought into the country or transported across state lines. See D’Agostino, Cancer Connection, San Diego Reader, Nov. 1976, at 1, 21-22:
This muddy situation has created a sort of Catch 22 for law enforcement officials. They know that the drug is almost always smuggled into the country . . . ; but they usually can’t confiscate the drug or prosecute its possessors without first proving that the drug was indeed smuggled.
Id. at 22, col. 1.
241 399 F. Supp. at 1208.
242 Id. at 1214.
243 Id. at 1213.
244 Id. at 1212-13.

had terminated the drug’s ND (Investigative New Drug) status for procedural reasons,245 leaving “cancer victims . . . in limbo with regard to laetrile, unable to invoke the jurisdiction of the courts.”246 The court concluded that it had equitable jurisdiction on the basis of hardship to the plaintiff, and that “[s]ince the Secretary has failed to act, the Court must act”24’—which it did by issuing a preliminary injunction against the FDA. The decision was appealed by the FDA to the Court df Appeals for the Tenth Circuit, which upheld the preliminary injunction on the ground that the administrative record was inadequate for review purposes, and remanded to the FDA “for proceedings adequate to develop a record supportive of the agency’s determination •“248
The direct holdings of the Oklahoma district court were that because cancer patients requesting laetrile treatment are wholly without means of complying with the FDA procedures for introducing a new drug into interstate commerce, FDA inaction has deprived them of life, liberty, or property without due process of law; and that because the FDA has failed to act, the courts have jurisdiction to act on behalf of these patients.249 That the right of the patient to choose his own treatment is a fundamental one was held by implication only, and the correlative right of the practitioner to administer the treatment was not mentioned.
The Alaska law, on the other hand, explicitly establishes that the right of the individual practitioner overrides that of not only hospitals and other health facilities but of the State Medical Board, absent proof of actual harm to the patient. The law forbids any hospital or health facility from interfering with a physician’s administration of laetrile unless the substance is found by the State Medical Board to be not merely ineffective against cancer but harmful to the patient. It also forbids the disciplining of a physician by the State Medical Board for administering the drug unless the drug is proven actually harmful.250 The bill es245 The IND had been terminated due to “preclinical deficiencies” which
had not been rectified in the ten days allotted by the agency. Id. at 1213. See note 99 supra.
246 399 F. Supp. at 1213.
247 Id.
248 Stowe v. United States, No. 75-1725, at 11 (10th Cir. Oct. 12, 1976). The court noted that the administrative record left unanswered the following questions:
(1) Was Laetrile marketed on October 9, 1962, as a cancer drug and was it then generally recognized as “safe?”
(2) Was Lactrile recognized or used as a cancer drug under the same conditions of present use during the period when the Food and Drugs Act of 1906 was in effect, June 30, 1906 to June 25, 1938?
Id. at 9 (footnote omitted). The court noted, “If the answer to either of these is ‘yes,’ Laetrile would be exempt as a ‘new drug’ under the Food, Drug and Cosmetic Act,” and concluded, “We regard these questions as substantial, difficult and doubtful so as to support the granting of a preliminary injunction.” Id.
249 399 F. Supp. at 1208-09.
250 See note 236 supra. The legislature was empowered to pass this bill in

tablishes that the point at which the state interest becomes “compelling,” so that the discretion of the individual practitioner may be overridden by the Mate, is that at which actual harm to the patient has been shown. The Alaska law thus represents a major departure from the FDA requirement that effectiveness must be proven by the applicant before use of the drug is approved.
(3) Recent Judicial Relaxation of the California Ban. It was the Oklahoma decision, however, which lay behind a January 1977 federal district court holding which for the first time permitted an individual to possess and use laetrile in California.251 The opinion relied on and repeated the reasoning of Rutherford in enjoining the FDA from preventing a California plaintiff from possessing a three months’ supply of the drug for his own use. The plaintiff was an elderly man, terminally ill with a cancer unresponsive to any recognized treatment. While not explicitly framing the issue in constitutional terms, the court stated that to deny the plaintiff “his freedom of choice, when there are no other remedies presently available, would appear grossly paternalistic to this court.”252 This equitable exception to the California statutory provision which makes cancer treatments illegal until administratively acknowledged to be effective is an isolated one of limited duration. Nevertheless, the tenor of the opinion suggests that the prior acceptance of statutory paternalism by the California judiciary may be changing toward favoring freedom of choice in cancer therapy. Unresolved is the question of physician haT biity for administration of the therapy. However, the logical corollary of the patient’s right of access to laetrile treatment is the physician’s right to administer the treatment.

IV. ALTERNATIVE PROPOSALS

Various alternative regulatory possibilities have been suggested to replace existing legislation restricting health treatments deemed unjustifiable under either a means scrutiny or a fundamental rights analysis. The following section will present and evaluate these alternatives.

A. Alternatives to Existing Licensing Legislation

Proposed alternatives to the licensing requirement range from the radical to the conservative. They will be treated below in that order.

the face of FDA failure to approve the drug because the FDA’s jurisdiction is limited to substances travelling in interstate commerce; a state is free to permit or forbid the use of substances manufactured within its own borders. See note 271 in Ira.
251 Carnohan v. United States, Civ. No. 77-0010-GT (S.D. Cal. Jan. 21,
1977).
252 Memorandum Opinion and Order at 4, id.

1. Tort Liability
The least restrictive alternative to the licensing requirement, representing the most radical change, is to curb quackery by relying on tort liability alone. Recovery would be assured in the event of mishap by the minimum requirement that practitioners be bonded; reimbursement of fraud victims would then proceed through ordinary consumer protection channels.
Under this system, quackery charges would follow upon consumer complaint rather than being state-instituted on technical grounds. The benefit thus afforded is that effective innovative treatments would have a chance to prove themselves on willing patients. The danger posed is that fraud victims, though having a chance of eventual recovery, might in the interim have exhausted the financial resources necessary for orthodox treatment, and victims of incompetence might in the interim have incurred irreparable bodily harm. In addition, the proposal raises awkward problems with respect to determining the proper standard of care for practitioners, finding “experts” to testify on the question of whether the standard has been met, and assigning liability for insurance purposes. It must be concluded that the alternative of eliminating the licensing requirement of the Medical Practice Act and relying on tort liability alone is not a viable one.

2. Certification

A more feasible suggestion for demonopolizing the medical field comes from economist Milton Friedman, who proposes replacing licensing with certification. He characterizes the latter as follows:
The governmental agency may certify that an individual has certain skills but may not prevent, in any way, the practice of any occupation using these skills by people who do not have such a certificate.25’

The traditional argument in support of medical licensing is that the layperson in need of a physician is not competent to judge whether a particular practitioner is qualified; the state’s endorsement of qualification in the form of a license is needed.254 However, argues Friedman, certification would achieve this end while sidestepping licensing’s concomitant social costs. He explains:
[T]he usual arguments for licensure, and in particular the paternalistic arguments, are satisfied almost entirely by certification alone. If the argument is that we are too ignorant to judge good practitioners, all that is needed is to make the

relevant information available. If, in full knowledge, we
still want to go to someone who is not certified, that is our
business; we cannot complain that we did not have the information.233

With the Friedman model, the public would be protected by disclosure of facts necessary for making an informed choice rather than by total prohibition of treatments which have not been officially endorsed. The proposal assumes a very good information market, however, and probably represents a more radical departure from the status quo than is practicable in the reasonably near future.

3. Amendment of the Medical Practice Act

The most modest and practical solution to the licensing problem is to retain the licensing requirement while legislatively and judicially altering its scope. Suggested alterations include narrowing the scope of the terms of the Act and providing special licenses for intermediate categories of practitioners.236
a. Narrowing the Scope of the Terms. The first modification of the Medical Practice Act might be legislative revision and judicial redefinition of the statutory language in order to make it accord more nearly with the popular conception of “practicing medicine.” The general rule is that “in construing a statute, nontechnical words should be given, if possible, their ordinary and general meaning.””’ It may be contended that the ordinary and general meaning of “medicine” involves the use of medicines;258 of “prescribing,” prescription drugs; and of “medical treatment,”

213 M. FRIEDMAN, supra note 108, at 149.
236 Elton Rayack, professor of economics at the University of Rhode Island, proposes an additional statutory modification: a restructuring of the medical licensing board, removing professionals from a policy-making to an advisory capacity. He asserts:
The principle of using physicians only in an advisory capacity . . . is applicable to the machinery for accrediting medical schools, to the determination of staff privileges in hospitals, to the limitations imposed on non-medical practitioners, to the operation of utilization review procedures, and to the determination of “reasonable charges” under the Medicare program. Wherever there is a need to set standards in the medical market and a possibility of conflict exists, physicians should not be in policy-making positions.
E. RAYACK, supra note 108, at 228 (emphasis added).
237 Labarthe v. McRae, 35 Cal. App. 2d 734, 738, 97 P.2d 251, 254 (1st Dist. 1939). See also Adams v. Lansdon, 18 Idaho, 483, 504, 110 P. 280, 287 (1910); Herring v. Poritz, 6 III. App. 208, 210 (1880).
238 See, e.g., Smith v. Lane, 31 N.Y. Sup. Ct. 632 (1881):
The practice of medicine is a pursuit very generally known and understood, and so also is that of surgery. The former includes the application and use of medicine and drugs for the purpose of curing, mitigating, or alleviating bodily diseases, while the functions of the latter are
692
UCLA LAW REVIEW
[Vol. 24: 647
medicines or surgery.259 By redefining its terms in this way, the licensing requirement might be limited to practitioners who prescribe medicines and/or treat patients surgically.280 Judicial redefinition of the terms of the licensing requirement along these more tailored lines, combined with legislative delimitation of the statutory definition of the practices for which licensing is required, would better serve the health interests for which the licensing requirement was intended; at the same time, it would minimize infringement of the layperson’s right to recommend non-prescription substances and employ harmless treatments,28’

limited to manual operations usually performed by surgical instruments or appliances .
Id. at 633-34 (emphasis added). See also People v. Fowler, 32 Cal. App. 2d Supp. 737, 84 P.2d 326 (1938):
[WIe conclude that the words “medicine” and “surgery,” as used in section 7 of the Chiropractic Act, were intended to continue as to chiropractors the limitations imposed on drugless practitioners by the Medical Practice Act, that is, to deny them the use of drugs and medical preparations and the severing or penetrating of the tissues of human beings. This accords with a quite common use of the two words in ordinary conversation.
Id. at 749-50, 84 P.2d at 333 (emphasis added).
259 See, e.g., Ex parte Gerber, 57 Cal. App. 141, 143, 206 P. 1004, 1005

(2d Dist. 1922), overruled on other grounds, Hall v. Steele, 193 Cal. 602, 607, 226 P. 854, 856 (1924), in which the court, after listing and eliminating the various Webster definitions of “treatment,” settles on “to care for medicinally or surgically” as the only one possible for the word as used in the phrase “treatment of the eye.”
260 Earlier licensing legislation and some case law support such a narrower
reading of the concept of “practicing medicine.” See text accompanying notes 15-19 supra; see also State v. Fite, 29 Idaho 463, 159 P. 1183 (1916), in which the court, citing many authorities, notes:
The courts of last resort of a number of states have passed upon statutes intended to regulate the practice of medicine and surgery. Some of them have held that the giving of treatments without the employment of instruments, appliances, or agencies such as are commonly used by physicians and surgeons, and without the use of drugs or medicines, is not violative of these statutes.
Id. at 467-68, 159 P. at 1184. A modern precedent for interpreting the concept narrowly is found in Shelton v. State, 377 S.W.2d 203 (Tex. Ct. Crim. App. 1964), in which a Texas court held that because the director of a “health school” was not “publicly professing to be a physician and surgeon,” he was not unlawfully practicing medicine, even though he conducted fasts which were for the purpose of alleviating disease and restoring health. Id. at 204-05.
261 Leonard Worthington, a Los Angeles attorney, proposes a rewriting of the Medical Practice Act which would have an effect similar to Friedman’s certification proposal: The patient, having given his informed consent, could patronize the unlicensed at his own risk. The proposal reads as follows:
Any person who advertises, claims, infers [sic] or holds himself out as being licensed by the State of California to practice medicine or as having a valid unrevoked certificate as provided in this chapter and who by such false misrepresentation uses any system or mode of treating the sick or afflicted in this State, or who diagnoses, treats, operates for or prescribes for any ailment, blemish, deformity, disease, disfigurement, disorder, injury, or other mental or physical condition of any person, is guilty of a misdemeanor.
Nothing contained in the foregoing shall limit or prevent any person who claims to have . . . a mode of treatment or effective remedy for any physical or mental condition from trying to alleviate any

b. Establish Intermediate License Categories. For intermediate categories of treatment—those not requiring the training of a physician or surgeon but nevertheless harboring malpractice potential—special license categories might be devised. Two recent California precedents are the midwife’s license and the acupuncturist’s certificate. The former, reinstated in 1974, authorizes the holder to attend at cases of normal childbirth but forbids the use of surgery or instruments except to cut the umbilical cord, and requires referral to a medical doctor in the event of complications.262 The latter, authorized by the California Senate in July of 1975, allows the holder to practice acupuncture without a medical license but makes prior diagnosis by a physician, surgeon, dentist, podiatrist or chiropractor a prerequisite to treatment.285

B. Alternatives to Existing Drug Regulation

Liberalization of drug regulation might be achieved judicially by a narrow construction of the regulatory language, on the model

condition in another, provided that said practitioner, before doing so,
complies with the following:
I. Said practitioner shall display in a prominent place in his office or home, visible to the patient, a statement indicating that said practitioner has not been licensed by any agency of the State of California to practice any form of healing or treatment, and
2. Said practitioner shall furnish to the patient a written statement embodying similar language indicating the fact that said practitioner is unlicensed and each patient treated by said practitioner shall sign his name and address on the bottom of each such written statement, giving the name and address of the patient’s consulting licensed physician, if any .
3. Said practitioner shall not diagnose the patient’s condition by naming any term commonly employed by any physician for said condition and shall also recommend that the patient report to a licensed physician of the patient’s own choice and inform said physician of the patient’s complaint and the nature of the treatment which has been afforded to the patient by said practitioner.
From a petition sent to interested parties through the mails, on file at the UCLA Law Review. The problem with this proposal, in addition to its adhesion contract potential, is its failure to limit administration of potentially dangerous treatments to licensed medical doctors. This omission might be rectified, however, by insertion of further appropriate provisions.
262 CAL. Bus. & PROF. CODE § 2350 (West Supp. 1976), added by Act of Sept. 23, 1974, ch. 1044, § 18, [1974] Cal. Stat. 2243.
283 CAL. Bus. & PROF. CODE § 2150 (West Supp. 1976). Acupuncture only recently stepped out of the quackery category to receive scientific recognition. Assuming other forms of unorthodox treatment achieve similar status their practitioners might be similarly certified for limited practice. A foreign precedent is the certification of psychic healers in Great Britain. The British government has recently officially licensed a number of healing homes and institutions in which psychic healers work in conjunction with medical doctors. See W. MANN, supra note 78, at 177. On the British model, certification guarantees moral character rather than training; it also makes the practitioner eligible for malpractice insurance. See S. HAMMOND, WE ARE ALL HEALERS 138-39 (1973).

of the interim holding in People v. Turner,2414 which allowed harmless drugs on the market so long as no unproven claims were made for them.265 This approach was also used by the Second Circuit in a 1974 case, in which it held that regulations of the FDA which would have resulted in “effectively ban[ning] the sale, as dietary supplements, of any vitamins or minerals not on the [FDA] approved list” were unreasonable and unlawful.266 In addition, courts may enjoin enforcement of administrative prohibitions against use of particular drugs where the prohibitions fail to accord with due process.
Legislatively, to discourage fraud without restricting freedom of choice, FDA prohibition of harmless drugs not proven effective might be replaced by the requirement of label warnings. Use would then be left to the consumer’s discretion, following full disclosure of risks.26’ Elimination of both the potential for arbitrary FDA action presented by the vague criterion of “effectiveness”268 and the cost in time and expense required to test harmless drugs in order to establish their effectiveness269 makes this proposal attractive.
A second legislative alteration at the federal level might be to follow the precedent established by the Alaska laetrile law, shifting the burden of proof from a drug’s proponents to the regulatory agency, and changing the nature of the proof required from a showing of effectiveness to a showing of either actual harm or at least ineffectiveness. However, while this proposal is attractive in theory, the additional cost to the agency which the requirement that it test every new drug on the market necessarily entails makes acceptance of the proposal unlikely.2’0

264 Crim. No. CR-32978 (Cal., San Diego Super. Ct. Feb. 2, 1976). See note 232 supra.
265 See note 184 & accompanying text supra.
266 National Nutritional Foods Ass’n v. FDA, 504 F.2d 761, 786-87 (2d
Cir. 1974), cert. denied, 420 U.S. 946 (1975).
267 A similar proposal has been made for potentially harmful drugs. An unprecedented system has been proposed by the FDA for distributing DepoProvera, a birth control drug whose cancer and sterilization risks are as yet unknown. According to the proposal, whenever a woman asked for the drug, her doctor would first give her a leaflet informing her of the risks and obtain her informed consent. Then he would mail her name to be inscribed on a national registry, so that in the event further testing revealed the drug did cause cancer, appropriate patient follow-up might be instituted. Zwerdling, Risky Birth
Control: Depo-Provera, NEW REPUBLIC, Nov. 9, 1974, at 7, 7-8. Notes Zwerdling, “This probably marks the first time the public is asked to accept responsibility for taking a dangerous drug, a policy that could make malpractice suits practically obsolete.” Id. at 8. If the proposal is accepted, it would add further weight to the argument that the consumer should be allowed market access to drugs which are harmless but not proven effective.
268 See note 134 & accompanying text supra.
269 See notes 151-52 & accompanying text supra.
270 See note 237 supra.

nally, a step which might be taken by state legislatures to ederal drug regulation is that of following the Alaska ~nt at the state level, specifically legislating to allow use ug which is not federally approved. A state may legislate way in opposition to a federal administrative ruling where jurisdiction is based on the commerce clause and the state ion is limited to intrastate activities.2” Whether other ~iay be expected to follow Alaska’s lead with respect to use probably depends on whether the test cases afforded drug by the Alaska law in fact prove its effectiveness in Ltment of cancer.

CONCLUSION

dministration of unorthodox health treatments in California ly restricted. The licensing laws prevent the unlicensed dministering any form of treatment. The licensed, who eoretically treat their patients according to their best profesjudgment, may not administer treatments which have not ureaucratically approved. And those unorthodox treatA’hich the licensed may legally give are unlikely to be given, economic and peer pressures to maintain conformity of ~nt.
‘hile the practitioner is both the focus of most health treatestrictions and the party legally liable for their breach, it atient, the intended beneficiary of the restrictions, who ultibears their cost. Restrictions on the patient’s right to his own treatment, a right which is included in the fundaright of privacy, are judicially justified in the name of a ling state interest in preserving the public’s health. As this mt has attempted to demonstrate, however, the cost of certhe existing restrictions weigh heavier than their benefits. blic health interest in treatments which are harmless but not blished effectiveness would be better served by legislation relied for determination of remedy effectiveness not on fedI state agencies but on the market itself.

See F.T.C. v. Simeon Mgt. Corp., 391 F. Supp. 697 (S.D. Cal. 1975):
direct control of medical practice has been left to the states and is ~nd the power of the federal government.

Furthermore, the FDA does not have jurisdiction to regulate the inistration of a drug by a physician. In order to invoke the jurison of the FDA, 21 U.S.C. § 355(a) [(1970)], requires a person to:
– . introduce or deliver … into interstate commerce any new drug
mhe California physician in his private treatment of a California ~nt with [a new drug] is engaging in a manifestly different quantitaand qualitative act than introducing or delivering for introduction interstate commerce.
5-07 (citation omitted).