1 During This Period, Although Physicians Did Prescribe Drugs, These Voluntary Prescriptions Were Not Subject to Stringent Governmental Control. Once Issued, the Initial Client or Others Could Use The Prescription Repeatedly. Like The Prescription Process, The Distribution Of Drugs Was Also Less Regulated Than It Is Today. Pharmacists Sometimes Copied A Formula And Sold It Directly. Most Physicians Dispensed Drugs Themselves Rather Than Write Prescriptions. Finally, Pharmacists Could Promote The Products They Offered. See P. Temin, Taking Your Medicine—Drug Regulation In The United States 22-23 (1980).

2 H. Grabowski & J. Vernon, the Regulation of Pharmaceuticals 2 (1982).

3 In the United States prior to 1913, individuals could purchase any drug, including opiates, directly over-the-counter (OTC). Legislation prior to 1938 did not focus on this availability, but rather on mislabeling and adulteration. See The Pure Food and Drugs Act of 1906, ch. 3915, 34 Stat. 768 (1906) repealed by Act of June 25, 1938, ch. 9, 52 Stat. 1059 (1938). In the 1930's the Massengill Company's use of diethylene glycol as a solvent in a sulfa preparation poisoned over 100 children. This sulfanilamide incident is widely credited with inspiring the 1938 Food, Drug and Cosmetic Act ch. 675, Stat. 1040 (1938) P. Temin, supra note 1, at 4. This Act ostensibly aimed to protect the public by requiring both pre-marketing proof of safety and more stringent labeling. See Temin, Costs and Benefits of Switching Drugs from Rx to OTC, 2 J. Health Econ. 187-88 (1983). However, the Food and Drug Administration (FDA) interpreted the Act's labeling provisions to invent a new category of drugs that could be sold by prescription only. Prescription-only requirements were interpreted in three ways:

• a) a drug labeled “Caution: to be used by or on the prescription of” a physician and sold on that basis was exempt from the labeling requirements of the Act. 3 Federal Register 3168 (Dec. 28, 1938).

• b) certain named drugs were intrinsically unsafe and therefore misbranded if the “prescription only” legend did not appear on the label, and

• c) “all drugs which may be dangerous to health, unless used under appropriate supervision” would be misbranded without the prescription warning. V. Klienfeld & C. Dunn, Federal Food and Cosmetic Act 1938-49, 562-63 (1949).

Peltzman, The Health Effects of Mandatory Prescriptions, 3 Workshop Series, at 2, Department of Economics, Carleton University, Nov. 2, 1985. This interpretation placed physicians “into a hierarchical process of medicinal decision-making with the FDA ultimately at the top.” Layne, , Restricting Access to Non-Psychoactive Medications: Public Health Necessity or Disabling Professional Prerogative?, 14 J. Drug Issues 595, 597 (1984)CrossRefGoogle Scholar. Congress formalized the FDA's authority to create and identify prescription-only substances in 1952 with the Durham-Humphrey Amendments to the Food, Drug and Cosmetic Act. Ch. 578, 65 Stat. 648 (1952). See J.T. Gibson, Medication, Law and Behavior 12-15 (1976) and Peltzman supra. Since other countries have also passed mandatory prescription laws during this period, it is difficult to attribute this innovation to circumstances specific only to the U.S. See, e.g., R.E. Curran, Canada's Food and Drug Laws 130-32 (1953); Wassenaar, , Drug Regulation in Canada, 2 Legal Med. Q. 209 (1978)Google Scholar. For a listing of mandatory prescription laws in other countries, see generally Controlling the Use of Therapeutic Drugs—An International Comparison (W. Wardwell ed. 1978).

4 See J. Lieberman, the Tyranny of the Experts 12-14 (1970); P. Temin, supra note 1, at 21.

5 A well-documented critique of medical controls is found in Baron, , Licensure of Health Care Professionals: The Consumer's Case for Abolition, 9 AM. J. L. & MED. 334 (1983)Google Scholar. See generally R. Hamowy, Canadian Medicine—a Study in Restricted Entry (1985); M. Larson, the Rise of Professionalism (1977); P. Elliott, the Sociology of the Professions (1972); I. Illich, I. Zola, J. Mcknight, J. Caplan & H. Shaiken, Disabling Professions (1977) [hereinafter cited as I. ILLICH].

6 See M. Larson, supra note 5, at 4-6. See generally Shortt, Physicians, Science and Status: Issues in The Professionalization of Anglo-American Medicine in the Nineteenth Century, 27 J. MED. HIST. 51-68 (1983).

7 J. Lieberman, supra note 4, at 269.

8 See, e.g., Dewees, Mathewson & Trebilcock, The Rationale for Government Regulation of Quality, in the Regulation of Quality 20-23 (D.N. Dewees ed. 1983) [hereinafter cited as D.N. Dewees].

9 M. Olson, the Rise and Decline of Nations 41-47 (1982). Olson also suggests that public concern about incompetent practitioners provides an “ideal cover” for professional cartel formation. Id. at 86.

10 Id. at 156. Viewing the caste system as the end product of professionalism lends support to Lieberman's argument that inherent in professionalism “is the negation of democracy.” J. Lieberman, supra note 4, at 7.

11 See M. Larson, supra note 5, at 5-6. Peltzman reports that there is a clear connection between economic development and the stringency of medical regulation. That is, in the poorer and usually less stable developing nations, the profession's monopolizing potential is limited. Peltzman, supra note 3, at 5.

12 See H. Waitzkin & B. Waterman, the Exploitation of Illness in a Capitalist Society (1974).

13 P. Temin, supra note 1, at 21.

14 See I. Illich, Limits to Medicine 70-74 (1976). Ugalde cites evidence from China, Cuba, Honduras and elsewhere regarding the “almost total control” physicians exercise over health policy and the promotion of their own economic interests that this control allows. Ugalde, Physicians Control of the Health Sector: Professional Values and Economic Interests—Findings from the Honduran Health System, 14A Soc. Sci. J. MED. 435 (1980). For a discussion of the relationship between a country's gross national product and “health” spending, see Newhouse, Medical Care Expenditure: A Cross National Survey, 12 J. Hum. Resources 1 (1976)Google Scholar.

15 Certification, which attests to having met certain training or performance standards, is not sufficient to prevent uncertified persons from practicing as was the case with apothecaries competing with 17th century physicians. M. Larson, supra note 5, at 11. Licensing regimes permit much stricter control as they exclude all unlicensed persons.

16 The post-secondary training period of physicians increased in this century from 1-3 years to 9 or more years for certain specializations. Critics charge that: 1) there is no connection between medical school performance and competence in practice, 2) the curriculum is inappropriate, 3) the conditions of residency are inimical to health or quality service, and 4) the major function of the process is to foster solidarity and reduce individualism, not to impart skill. See A. Allentuck, who Speaks For the Patient? 81-89 (1978); R. Mendelsohn, Confessions of a Medical Heretic 130, 160 (1979).

17 J. Cady, Restricted Advertising and Competition: the Case of Retail Drugs (1976). The term “ethical” drug derives from the AMA's 1847 Code of Ethics which excludedadvertising. “Proprietary” medicines were advertised to the public. These compounds included“patent medicines,” whose contents were secret—not patented—thus even their generic class label was fraudulent. See P. Temin, supra note 1, at 3. Patent medicines usually contained alcohol, opiates or stimulants such as coca and strychnine. The availability, advertisement, and use of such nostrums increased dramatically in Canada from 1860 to 1900. R. Smart, Forbidden Highs 5-7 (1983).

18 See Trebilcock, Regulating Service Quality in Professional Markets, in D.N. Dewees, supra note 8, at 102. Governments may favor grants of monopoly and self-regulation to professions because no government expenses are incurred, an illusion of public protection is created and valuable property rights are conferred on the professional group, rights that are presumably “purchased” in some manner. Id. at 103. He concludes that licensure suffers from “severe disabilities in terms of consumer welfare,” disabilities that are amplified if licensure is selfregulated. A good textbook discussing the benefits of medical competition is P. Feldstein, Health Care Economics (1979).

19 See Benham, & Benham, , Regulating through the Professions: A Perspective on Information Control, 18 J.L. & ECON. 421 (1975)CrossRefGoogle Scholar. I argued in an earlier article on the legal profession that anti-advertising measures and information control are, in reality, the unethical practices. Mitchell, , The Impact, Regulation and Efficacy of Lawyer Advertising, 20 Osgoode Hall L.J. 119 (1982)Google Scholar.

20 Dolan, Antitrust Law and Physician Dominance of Other Health Professionals, 4 J. Health Pol. Policy & L. 675, 681-83 (1980).

21 See, e.g., H. Lewis & M. Lewis, the Medical Offenders 294-305 (1970). See generally E. Cray, in Failing Health—The Medical Crisis and the Ama (1970); Knowles, The Responsibility of the Individual, in Doing Better and Feeling Worse 76 (J. Knowles ed. 1977) [hereinafter cited as J. Knowles]; Dolan, supra note 20, at 677-81. These sources report that the AMA and local medical organizations generally and consistently work to the detriment of the patient. For example, Olson advises that professional and government intervention in the medical care system “mainly helps physicians and other providers.” M. Olson, supra note 9, at 174. See generally a New Approach to the Economics of Health Care (M. Olson ed. 1982).

22 See Cohen, , On Professional Power and Conflict of Interest: State Licensing Boards on Trial, 5 J. Health Pol. Policy & L. 291 (1980)CrossRefGoogle Scholar; R. Mccleory, L. Keelty, M. Lam, R. Phillips & T. Quirin, One Life—One Physician (1971); H. Lewis & M. Lewis, supra note 21, at 29; Beveridge, Regulation of the Medical Profession in Nova Scotia 5 Dalhousie L.J. 518, (1979).

23 An early and influential work on the subject is E. Freidson, Professional Dominance: the Social Structure of Medical Care (1970). See generally L. Doyal, the Political Economy of Health (1979); I. Kennedy, the Unmasking of Medicine (1981); Ladd, Physicians and Society: Tribulations of Power and Responsibility, in The Law—Medicine Relation: A Philosophical Exploration 33, 41 (S. Spicker, J. Healey, & H. Engelhardt eds. 1981); P. Starr, the Social Tranformation of American Medicine (1982).

24 See L. Lasagna, the Doctor's Dilemma 154 (1962); L. Tushnet, the Medicine Men 12-16, 84-86 (1971); M. Crichton, Five Patients—The Hospital Explained ix (1970). Evidence indicates that dramatic increases in health input (hospitals, physicians, nurses, drugs) are not matched by equivalent increases in health output. M. Tonkin, South Africa—A Nation of Pill Swallowers?, Institute For the Study of Man in Africa, Paper #35, July 1977, at 9. Knowles reports that half of the reduced mortality rate accomplished over the past 300 years occurred prior to 1900. Medicine contributed only 10% to this reduction in the last 100 years. J. Knowles, supra note 21, at 57. In addition to exaggerating medicine's role in increasing longevity, modern opinion also misunderstands the nature of the gain in an average life span. This gain is almost entirely the result of treatments received as a child, whereas the gains due to care received at ages 40 or 50, when drug therapy intensifies, are “insignificant.” Schuman, Smoking as a Risk Factor in Longevity, in Aging: A Challenge to Science and Society 204 (D. Danon, N. Shock & M. Marois eds. 1981); Fries & Grapo, Physiologic Aging and the Compression of Morbidity, Conference on Health in the 80s and 90s 87 (1982) (Council of Ontario Universities); Wildavsky, Doing Better and Feeling Worse: The Political Pathology of Health Policy and Eisenberg, The Search for Care, in J. Knowles, supra note 21, at 105, 235.

25 The mechanical and scientific germ theory of disease was, in Knowles's words, “simple, unitary and compelling” and in harmony with our culture's general faith in science and technology. Knowles, supra note 21, at 58. Unfortunately, excessive focus on technical medical intervention diminished other important health factors such as personal behavior and hygiene, sewers, environmental factors, birth control, ethics and wealth. Id. at 57-58.

26 Zola, Healthism and Disabling Medicalization, in I. Illich, supra note 5, at 46-55.

27 Antibiotics, which entail some risk of adverse effects, are prescribed for conditions they cannot affect despite evidence of their ineffectiveness. See L. Tushnet, supra note 24, at 196-97. Internationally, antibiotics are “among the most widely mispromoted, misprescribed and misused of all prescription drugs.” M. Silverman, P. Lee & M. Lydecker, Prescriptions For Death: the Drugging of the Third World 19-20 (1982).

28 In 1900, U.S. mental institutions contained 130,000 inmates. By 1978, there were 1.8 million inpatients and 4.9 million outpatients. D. G. Garan, Against Ourselves 10 (1979). Officially, inmates in mental institutions fell from 550,000 in 1955 to 300,000 in 1975. But, as Schrag explains, “vast increases in the resident population of nursing homes and halfway houses more than compensated for the decline—many people were simply reclassified from mentally ill to old, and dumped in another institution.…” P. Schrag, Mind Control 38 (1978). In Japan, the “greatest increase in psychiatric beds occurred at a time of wide-spread use of psychotropic drugs, regarded in many countries as instrumental in decreasing the in-patient population.” Ikegami, Growth of Psychiatric Beds in Japan, 14A Soc. Sci. & MED. 561 (1980). See also M.L. Gross, The Psychological Society 7 (1978).

29 Physicians are the only class of health professionals whose licenses are unlimited. J. T. Gibson, supra note 3, at 14. Compare prescribing privileges of physicians with those of nurse practitioners. See Labar, Filling in the Blanks on Prescription Writing, 86 AM. J. Nursing 30 (January 1986). Moreover, laws often compel clients to accept a physician overseer in addition to the other health professional providing primary service. Since 1975, however, physician organizations have faced increased anti-trust actions from competitors such as chiropractors. Dolan, supra note 20, at 676, 681. See generally Heitler, , Health Care and Antitrust, 14 U. TOL. L. REV. 577 (1983)Google Scholar; Weller, , The Primacy of Standard Antitrust Analysis in Health Care, 14 U. TOL. L. REV. 609 (1983)Google Scholar.

30 See L. Tushnet, supra note 24, at 102-04; Rogers, The Challenge of Primary Care, in J. Knowles, supra note 21, at 81, 99. On the issue of effectiveness in psychotherapy, see the survey of literature in Mitchell, , Culpable Mental Disorders and Criminal Liability, 8 International Journal of L. & Psychiatry 273 (1986)CrossRefGoogle Scholar. On birth, and the merits of physicians versus midwives and others, see generally G. Corea, the Hidden Malpractice (1977); R. Mendelsohn, Malpractice (1980); Seizing Our Bodies—The Politics of Women's Health (C. Dreifus ed. 1978). With respect to fertility regulating, Paxman suggests that “the requirement that a physician's prescription precede the issuance of oral contraceptives is still one of the single most effective limitations on roles for non-physicians.” Paxman, , Roles for Non-Physicians in Fertility Regulation: An International Overview of Legal Obstacles and Solutions, 70 Amer. J. Pub. Health 31, 32 (1980)CrossRefGoogle Scholar. On drug expertise, Layne argues that “the average physician's knowledge of medications is rather cursory compared to other health professionals.” Layne, supra note 3, at 602. Physicians’ orientation to clinical practice renders them ill-suited to do the research necessary to investigate drug effects. P. Temin, supra note 1, at 10-11.

31 Midwives, for example, provide superior birthing services for normal births and home births; in many cases, however, such services are not covered by private or public insurance. Patients, therefore, have the choice of paying midwives directly or going to a hospital where a physician will attend the birth at no direct cost.

32 One commentator identifies the tendency of physicians to appropriate all of life into the medical domain by means of theological “paradigms.” Raymond, , Medicine as Patriarchal Religion, 7 J. MED. & PHIL. 197 (1982)CrossRefGoogle Scholar. Reporting on the medicalization of minor problems, such as anxiety, and the growth of dependency on symptomatic “medical” treatments such as tranquilizers, another commentator points out that “15% of Americans use a minor tranquilizer of some kind” during a typical year. The practice of sedating elderly nursing home residents as a service to their caretakers is also identified as an example of how sociobehavioral problems are turned into medical issues requiring drug solutions. Koumjian, The Useof Valium as a Form of Social Control, 15E Soc. Sci. MED. 245-47 (1981); I. Illich, supra note 14, at 52-56.

33 Fox, The Medicalization and Demedicalization of American Society, in J. Knowles, supra note 21, at 11, 18. Fox notes, however, that certain preliminary “demedicalization” steps have been taken. Id. at 18-19. See also R. Mendelsohn, supra note 16, at 36 (discussing the strategic expansion of medical diagnosis to capture research funds and subsidies).

34 With respect to the medicalization of anti-social behaviors, see generally MacNamara, , The Medkal Model in Corrections, 14 Criminology 439 (1977)CrossRefGoogle Scholar; Ericson, , Penal Psychiatry in Canada: The Method of Our Madness, 26 U. Toronto L. J. 17 (1976)CrossRefGoogle Scholar; Reisner, & Semmel, , Abolishing the Insanity Defense, 62 Calif. L. Rev. 753, 776 (1974)CrossRefGoogle Scholar; Wilson, , What Works? Revisited: New Findings on Criminal Rehabilitation, 61 Public Interest 3 (1980)Google Scholar. With respect to the medicalization of alcohol use, see Tournier, , The Medicalization of Alcoholism: Discontinues in Ideologies of Deviance, 15 J. Drug Issues 39 (1985)CrossRefGoogle Scholar; see also Poikolainen, , Alcoholism: A Social Construct, 12 J. Drug Issues 361 (1982)CrossRefGoogle Scholar (discussing the disease concept of alcoholism and why this concept fails).

35 In Canada, for example, physicians are the highest paid professionals. Their income increased 12% annually between 1960 and 1975. Eight percent of Canada's GNP is allocated to health care. A. Allentuck, supra note 16, at ch. 2. In the U.S., the portion of GNP involving health care increased from 5% in 1960 to 11% in 1986. Wall St. J., Sept. 28, 1987, at 1, col. 5.

36 M. Larson, supra note 5, at 20.

37 By 1941, the FDA had added approximately 30 drug categories to the Rx list. Thereafter, almost all newly approved drugs, developing at a rate of 50 per year in the 1950s and 20 per year in the 1960s, were automatically considered prescription medicines. P. Temin, supra note 1, at 5. One commentator makes two important observations about this development. First, only one of the active drug ingredients listed as Rx in 1939 is still considered effective. Second, drug producers found the Rx category very useful because it required no labeling. As a result, producers were labeling products as Rx drugs “even though they contained ingredients which were readily available in the OTC market products.” Yingling, , Does Self-Medication Have a Role in Our Society, 36 Food Drug Cos. L. J. 604, 614 (1981)Google Scholar.

38 Peltzman, supra note 3, at 6; P. Temin, supra note 1, at 3-4.

39 Peltzman, supra note 3, at 6. Estimates of the total value of retail outpatient sales of prescription drugs in 1980 were as high as $14.5 billion. In the period 1965-1978, U.S. domestic sales increased 220% and exports grew by 560%. Wertheimer, An Empirical Overview of the Prescription-Drug Market, in Society and Medication: Conflicting Signals For Prescribers and Patients 3-4 (J. Morgan & D. Kaganeds. 1983) [hereinafter cited as J. Morgan].

40 Peltzman, supra note 3, at 35. Between 1950 and 1976, the number of annual prescriptions per person increased from 2.4 to 6.9. Since 1976, there has been a slight decline. Rabin, Variations in Physician Prescribing Patterns, in J. Morgan, supra note 39, at 17-18.

41 Physicians, with their unlimited license, are allowed to prescribe and dispense. J.T. Gibson, supra note 3, at 14. In less developed countries it is reported that poorly paid physicians “have a strong incentive to maintain a virtual monopoly over not only the prescribing of drugs but also over the dispensing of drugs.” See M. Silverman, P. Lee & M. Lydecker, supra note 27, at 90. The same physicians also seek a monopoly on information refusing even to identify the drug being prescribed. Id. at 92.

42 M. Larson, supra note 5, at 161.

43 Id. at 165.

44 Peltzman, supra note 3, at 4.

45 At present, half of all visits to a physician take less than 15 minutes. Moreover, writing a prescription is often an expected and easy way to end a visit. Koumjian, supra note 32, at 248; P. Temin, supra note 1, at 118. The average practitioner treats primarily by prescribing drugs, seeing about 90 patients a week for an average of 17 minutes each. J. Graedon, the PeoplE's Pharmacy 4 (1976).

46 Koumjian, supra note 32, at 249.

47 See R. Hughes & R. Brewin, the Tranquilizing of America (1979); E. Goode, Drugs in American Society 10 (1984). See generally M. Mintz, the Therapeutic Nightmare (1965); W. Mendelson, the use and Misuse of Sleeping Pills (1980); E. Hartman, T He Sleeping Pill (1978).

48 Since the placebo effect is psychologically caused, although of course physiologically manifest, the physician's success in this area will probably parallel the record of success in overt psychological therapies where it appears that neither academic nor technical qualifications are related to effectiveness. See B. Zilbergeld, the Shrinking of America: Myths of Psychological Change 114-41, 150-65 (1983).

49 GPs write more prescriptions than specialists. Cooperstock, , Current Trends in Prescribed Psychotropic Drug Use, 3 Research Advances Alcohol & Drug Probs. 297, 299 (1977)Google Scholar.

50 The FDA prosecuted pharmacists in several key cases in the 1940s. United States v. Sullivan, 67 F. Supp. 192 (M.D. Ga. 1946), rev'd, 161 F.2d 629 (5th Cir. 1947), rev'd, 332 U.S. 689 (1948); United States v. Marmola Prescription Tablets, 48 F. Supp. 878 (W.D. Wis. 1943), aff'd, 142 F.2d 107 (7th Cir. 1944). The ensuing mandatory prescription requirements empowered the FDA to prosecute pharmacists who sell Rx drugs OTC for the illegal practice of medicine. Layne, supra note 3, at 599.

51 Not surprisingly, physicians who own an interest in a pharmacy or drug supply firm prescribe at above-average rates. H. Lewis & M. Lewis, supra note 21, at 105.

52 See generally B. Barber, Drugs and Society 52, 106-12 (1967). For a critical view of pharmacists’ knowledge and skill see generally Barnes & Chappell, Pharmacists’ Knowledge in the Area of Alcohol, and Alcohol and Drug Interactions, 15A Soc. Sci. MED. 649 (1981). The study, however, does not compare pharmacists with physicians.

53 See M. Olson, supra note 9, at 66; Friedman, Capitalism a Freedom 137-60 (1962).

54 Schrag, Mind Control 122-25 (1978).

55 See Stroeder, the Politics of Drugs 105, 156 (1980). Reportedly, American physicians receive 2 billion free drug samples a year, many of which are given to clients. Id.

56 I. Illich, supra note 5, at 72, 76; P. Temin, supra note 1, at 118.

57 See Layne, supra note 3, at 600-03; Yingling, supra note 37, at 614-15. Yingling explains that the National Association of Retail Druggists was alarmed by restrictive FDA policies prohibiting Rx refills without physician approval. Two pharmacists, Congressman Durham and Senator Humphrey aided the passage of a 1951 Amendment without serious opposition or public comment. Id. (citing The Durham-Humphrey Bill, 5 Food Drug & Cosm. L.J. 854 (1950)Google Scholar.

58 T. Szasz, Ceremonial Chemistry: The Ritual Persecution of Drugs, Addicts and Pushers 138-40 (1974).

59 See J. Gabe & P. Williams, Tranquilizers 3-13 (1986); R. Caplan, Tranquilizer use 8c Well Being (U. Mich. Survey Research 1984). By counting all psychoactives, Cooperstock found that 43.3% of all prescriptions dispensed in Canada “contained a mood altering substance.” Cooperstock, supra note 49, at 303-05.

60 Alcohol, for example, was the most prescribed drug in the 1800's in psychiatric institutes. CD. Leake & M. Silverman, Alcoholic Beverages in Clinical Medicine (1966); Opler, Principles of Psychopharmacology 32, 45 (W.G. Clark & J. del Guidice eds. 1970).

61 See the summary of the literature in Mitchell, A Justice-Based Argument for the Uniform Regulation of Psychoactive Drugs, 31 Mcgill L.J. 212, 221-30 (1986).

62 See H. Teff, Drugs, Society and the Law 9 (1975); M. Smith & D. Knopp, Pharmacy, Drugs, and Medical Care 158-61 (1972). Teff disparages the pre-1908 period because opium based medicines “were in constant demand, in an age when self-medication and self-diagnosis—primarily with a view to symptomatic relief—were regarded as normal.” H. Teff, supra. This implies, quite inaccurately, that psychoactive Rx medication is no longer merely used for symptomatic relief.

63 A. CHase, the Biological Temperative 207 (1971). Opium, morphine and injected morphine and opium were, in turn, judged non-addictive by medical authorities. Id.

64 For those state laws, see Bonnie, & Whitebread, , The Forbidden Fruit and the Tree of Knowledge: An Inquiry into the Legal History of American Marijuana Prohibition, 56 VA. L. REV. 971, 986 (1970)CrossRefGoogle Scholar.

65 N. Longmate, the Water Drinkers 172 (1968). “Laymen” wrote many of the healthbased attacks on alcohol. Id.

66 Goldberg explains that the medical establishment did not change its views after 1917 because it “never had a clear-cut view it could change.” Goldberg, Putting Science in the Constitution: The Prohibition Experience, Law, Alcohol, and Order 21, 27 (D.E. Kyviged. 1985) [hereinafter cited as D.E. Kyvig]. In 1922, the AMA held a referendum in which 51% of the responding members agreed that whiskey was a necessary therapeutic agent in the practice of medicine. Id. The AMA eventually became a source of anti-prohibition authority, a position adopted, in part, because the AMA was “pressured by increasing restrictions on the ability of doctors to prescribe alcohol.” Id. at 27-28.

67 See, e.g., R. Sobel, They Satisfy—the Cigarette in American Life 51-56, 182-99, 236-39 (1978); T. Szasz, The Therapeutic State 261-62, 277-78 (1984). For an informative survey of the literature, see generally Garfield, Alcohol: Are the Benefits Worth the Risk?, Current Comments, April 13, 1981, at 5-13.

68 R. Sobel, supra note 67, at 52; see also Bynum, , Alcoholism and Degeneration in 19th Century European Medicine and Psychiatry, 79 BRIT. J. Addiction 59, 63 (1984)CrossRefGoogle Scholar.

69 Canadian Proprietary & Patent Medicine Act of 1908, Can. Rev. Stat. ch. 56 (1908).

70 See R. Smart, Forbidden Highs 9 (1983).

71 J. Helmer, Drugs and Minority Oppression 9 (1975).

72 A review and critique of the relevant literature can be found in Boyd, , The Origins of Canadian Narcotics Legislation: The Process of Criminalization in Historical Context 10 Dalhousie L.J. 102 (1986)Google Scholar; J.L. Himmelstein, the Strange Career of Marijuana (1983). The United States Pharmacopeia listed marijuana as a medicine from 1850 to 1942. Its medicinal popularity declined after 1900, but its ultimate decline was due to efforts of the Federal Bureau of Narcotics. See Lauderdale, & Inverarity, , Regulation of Opiates, 14 J. Drug Issues 567 (1984)CrossRefGoogle Scholar.

73 S. Cashman, Prohibition, the Law of the Land 205-07 (1981). Cashman cites examples such as Michigan's Habitual Criminal Act. This authorized a life sentence penalty for four convictions under the state's alcohol control law. Of all federal prisoners during the 1920's, nearly 40% were convicted under the Volstead Act, which, pursuant to section 2 of the eighteenth amendment, outlawed the unauthorized possession of intoxicating liquor. Volstead Act, ch. 85, 41 Stat. 305 (1919) (repealed 1935). See also Solomon, Regulating the Regulators: Prohibition Enforcement in the Seventh Circuit, in D.E. Kyvig, supra note 66, at 81.

74 See N. Zinberg & J. Robertson, Drugs and the Public 201-42 (1972); J. Kaplan, the Hardest Drug: Heroin and Public Policy 50, 57 (1983). See generally S. Wisotsky, Breaking the Impasse in the War on Drugs (1986).

75 D. Courtwright, Dark Paradise—Opiate Addiction in America Before 1940 113, 126, 147 (1982). In contrast, Helmer argues that even before 1920, opiates were mostly confined to the lower socio-economic classes. J. Helmer, supra note 71, at 7.

76 S. Cashman, supra note 73, at 252-56. On alcohol use from 1920 to 1930, see H. Lee, How Dry we were—Prohibition Revisited 193-206 (1963).

77 Harrison Act, P.L. 63-223, 38 Stat. 785 (1914) (codified as amended, 26 U.S.C. 4701- 4706 (1964)) (repealed 1970). Ostensibly a mere tax imposition, the Harrison Act required importers, producers, and distributors of opium and cocaine to register and pay an occupational tax. Only “legitimate” persons could register and only registered persons could obtain the required transfer forms to buy or sell the drugs. 26 U.S.C. § 34701, § 34703. The Harrison Act was first enforced by the Narcotics Division of the Prohibition Unit of the Internal Revenue Service created in 1920. For a thorough analysis see McLaughlin, Cocaine: The History and Regulation of a Dangerous Drug, 58 Cornell L. REV. 537, 560-66 (1973).

78 T. Szasz, supra note 58, at 150. On parallel developments in Britain, see V., Breckinridge, Drugs and Social Policy: The Establishment of Drug Control in Britain 1900-30, 79 Brit. J. Addiction 17 (1984)Google Scholar.

79 R. v. Gordon, 49 C.C.C 272 (Calgary Dst. Ct.) (1928). After 1925, an amendment to the Canadian Opium and Narcotic Act made unlawful prescription an indictable offense punishable by a minimum three-month imprisonment. Can. Rev. Stat. ch. 22, § 5 (1923).

80 Willis-Campbell Act of 1921, ch. 134, 42 Stat. 222, 223 (1921) (repealed).

81 Each year of Prohibition, U.S. physicians wrote an average of 10 million prescriptions for approximately 1 million gallons of alcohol. However, the Willis-Campbell Act of 1921 provided that physicians could not prescribe beer or more than 1/2 pint of alcohol per person in any 10-day period. S. Cashman, supra note 73, at 40, 153.

82 The Federal Bureau of Narcotics, for example, monopolized the distribution of information about marijuana from 1935 to 1960 and manipulated the AMA to suit its own purposes. J.L. Himmelstein, supra note 72, at 148.

83 S. Cashman, supra note 73, at 12.

84 See Goldberg, supra note 66, at 21.

85 D. Courtwright, supra note 75, at 113.

86 T. Szasz, supra note 58; Breckenridge, supra note 78.

87 The mistake was natural. The Harrison Act began as a revenue measure. Moreover, it is possible that some physicians hoped to prohibit opium but retain a monopoly on the prescription of morphine and heroin. Himmelstein argues that in its early form the Act created a near monopoly for physicians. J.L. Himmelstein, supra note 72, at 21-33. The medical profession's response to, and the legislative history of the Harrison Act is recounted in R. King, the Drug Hang-Up: America's Fifty Year Folly 33-59 (1972). The author comments that “what had commenced as a controversy within the medical profession evolved into a relentless attack upon the medical community, carried on by police authorities whose leadership and direction came from Treasury officials in Washington.” Id. See also Saper, The Making of Policy Through Myth, Fantasy and Historical Accident: The Making of America's Narcotics Laws, 69 Brit. J. Addiction 183, 187-89 (1974).

88 D. Courtright, supra note 75, at 126-30.

89 Id. at 126-40.

90 Id. at 140-44.

91 Bonnie & Whitebread, supra note 64, at 988-89.

92 By 1940, “narcotics” were regulated by the Harrison Act, 38 Stat. 785 (1914) (codified as amended 26 U.S.C. §§ 4701-4706 (1964) (repealed 1970), the Narcotic Drugs Import and Export Act of 1908, ch. 100, 35 Stat. 614 (repealed 1970) and the Uniform Narcotic Drug Act of 1932 adopted by most states, 9B Uniform Laws Annotated 409-10. At present, the Comprehensive Drug Abuse Prevention and Control Act, 21 U.S.C. §§ 801-966 (1976) governs the general status of drugs in the United States.

93 See, for example, the role played by physicians in the Drug Abuse Office and Treatment Act of 1972, Pub. L. No. 92-255, 86 Stat. 65 (codified as amended in scattered sections of 21 U.S.C.) and the Comprehensive Alcohol Abuse and Alcoholism Prevention, Treatment and Rehabilatation Act 81970S, Pub. L. No. 91-616, 84 Stat. 1848 (codified as amended in scattered sections of 42 U.S.C). Dupont recommends that physicians “routinely conduct urine testing for illicit drugs—especially among adolescents… .” R. Dupont, Jr., Getting Tough on Gateway Drugs 317 (1984). See also J.T. Gibson, supra note 3, at 12.

94 Since “narcotic” is a legal term rather than a scientific designation, law makers may classify any substance a “narcotic” for purposes of legal control. See Kaplan, Classification for Legal Control, in Controlling Drugs 284 (R. Blum ed. 1974).

95 Under the Food, Drug and Cosmetic Act, all “new” drugs must be approved by the FDA before marketing. 21 U.S.C. § 355 (1970). Since 1962, all unknown or newly synthesized substances have required FDA preclearance. Furthermore, a drug must be limited to Rx status if it possesses any of three characteristics, one of which is a tendency to lead to dependency. 21 U.S.C. § 353(b)(1). As all psychoactive drugs are habit forming, new psychoactives must be approved as medicinal by the FDA and then should be assigned to Rx status. See R. Merrill, Compensation for Prescription Drug Injuries, 59 Va. L. Rev. 1, 6-9 (1973).

96 See generally S. Fredman & R. Burger, Forbidden Cures 174 (1976); W. Mendelson, supra note 47; M. Mintz, supra note 47, at 57-62, 85. For example, as a medication, amphetamines were considered “remarkably safe,” but as illicit drugs, amphetamines reportedly caused “high mortality risk.” Kalant, & Kalant, , Death in Amphetamine Users: Causes and Estimates of Mortality, 3 Research Ad. Alcohol & Drug Probs. 317 (1976)Google Scholar. The authors conclude that neither of these views were based on thoroughly documented evidence. Id.

97 See the sources listed supra note 47.

98 See generally Moss, Methadone's Rise and Fall, in Drugs & Politics (P. Rock ed. 1977).

99 See, e.g., CD. Leake & M. Silverman, supra note 60. Cf. Angler, Marijuana: Bad News and Good, Discover August 1981, at 15. Angler reports that the FDA recently reclassified THC as a Class C drug having “clinical applications.” Id. See generally Zentner, Heroin: Devil Drug or Useful Medicine, J. Drug Issues 335 (1979). On cocaine's use as a medicine, see Ritchie & Cohen, Cocaine, Procaine and Other Synthetic Local Anesthetics, in the Pharmacological Basis of Therapeutics 379 (A.G. Gilman, L. Goodman 5th eds. 1975).

100 Havighurst, & King, , Private Credentialing of Health Care Personnel: An Antitrust Perspective, 9 AM. J. L. & MED. 263, 293 (1983)Google Scholar.

101 For an interesting exploration of the physician-patient relationship, see J. Katz, Acknowledging Uncertainty: The Confrontation of Knowledge and Ignorance, the Silent World of Doctor and Patient (1984).

102 One commentator claims that barbiturates are more alcohol-like than diazepam, but the difference may be due to the fact that barbiturate use has a longer history. R. Dupont, JR., supra note 93, at 10.

103 Aspirin use is the leading cause of accidental poisoning among young children. See, S. Fredman & R. Burger, Forbidden Cures 63 (1976); Silverman & Lee, Pills, Profits & Politics 225, 276 (1974); J. Graedon, supra note 45, at 13.

104 See Consumer Reports, Licit and Illicit Drugs 249-52 (E. Brecher ed. 1972).

105 One reputable report listing drugs in descending order of “danger” begins with tobacco, alcohol and cocaine and ends with cannabis. H. Teff, supra note 62, at 148.

106 One commentator speculates that if ethyl alcohol had been discovered recently, “notorious groups” of students, artists, criminals and other reprobates would begin experimental and “secret” use of the drug. This notion evidences the standard bias against personally initiated drug use and implies that it is proper and fitting for new drugs to be marketed only as prescription or OTC medicines. R. Whitaker, Drugs and The Law 2 (1969).

107 Prescription drug manufacturers often produce OTC formulations that contain identical substances. M. Silverman & P. Lee, supra note 103, at 217-27. See also Vener, , Krupka, & Climo, , Drugs (Prescription, Over-the-Counter, Social) and the Young Adult: Use and Attitudes, 17 Int'L J. of Addiction 399, 400 (1982)CrossRefGoogle Scholar.

108 The loss would also be a personal one to physicians who are enthusiastic consumers of medical psychoactives. See H. Lewis & M. Lewis, supra note 21, at 299.

109 On the subject of politics, ideology and pseudoscience as the norm in the drug field, see E. Goode, supra note 47, at 10-14.

110 Peltzman, supra note 3, at 41-42.

111 See, J. Graedon, supra note 45, at 3-7; M. Silverman & P. Lee, supra note 103, at 224-29. Fried writes of Americans’ “semi-religious” ritual of everyday vitamins. J. Fried, the Vitamin Conspiracy 184 (1975); see also J. Levy & P. Bach-Y-Rita, Vitamins—Their use and Abuse 99 (1976).

112 Brackins, , The Liability of Physicians, Pharmacists, and Hospitals for Adverse Drug Reactions, 34 Def. L. J. 273, 279, 332 (1985)Google Scholar.

113 P. Temin, supra note 1, at 119.

114 M. Silverman & P. Lee, supra note 103, at 22-23, 296-99, 301; R. Mendelsohn, supra note 16, at 32; J. Graedon, supra note 45, at 3, 37,47. See also M. Mintz, supra note 47, at 217. The prescription use of clioquinal (Entero-Vioform) in Japan, leading to perhaps the world's worst drug disaster, illustrates the limited efficacy of physician supervision. Clioquinal was developed in California in the 1930's for amebic dysentery. It was not useful for ordinary diarrhea or the prevention of disease. Because of the significant dangers involved, its developers issued warnings not to use the drug for more than two weeks. Despite these warnings, between 1950 and 1970, physicians prescribed it to millions of Japanese who used it daily for extended periods. The Japanese government and the producers, Ciba-Geigy paid a damage award of nearly $500 million. The prescribing physicians paid nothing. M. Silverman, P. Lee, & M. Lydecker, supra note 27, at 49-51.

115 L. Tushnet, supra note 24, at 199-203; P. Temin, supra note 1, at 118.

116 M. Mintz, supra note 47, at xiii, 73, 76, 86, 217. Mintz reports that while the AMA argues that only physicians possess the knowledge, ability and responsibility to make drug use decisions, physicians are gullible, uncritical and overwhelmed by experts. They are illinformed about drug dangers and “passionate” advocates of psychoactive drugs. Id. at 185. Other critics maintain that it is “impossible” for physicians to keep abreast of pharmacological matters. M. Silverman & P. Lee, supra note 103, at 50, 203.

117 I. Illich, supra note 5, at 70. These authors claim that by 1975, “medicalized addiction” surpassed self-inflicted addiction. It is reported that while physicians may believe that:

Prescott, & Highley, , Drugs Prescribed for Self Poisoners, 290 Brit. Med. J. 1633, 1635 (1985)CrossRefGoogle Scholar.

118 Feldman, The Handwriting is On the Wall, 11 Legal Aspects Med. Prac. Sept. 1983 at 8.

119 M. Silverman & P. Lee, supra note 103, at 301-04.

120 R. Mendelsohn, supra note 16, at 46; I. Illich, supra note 5, at 93, 105-12.

121 Diehr, , Increased Access to Medical Care—the Impact on Health, 17 Med. Care 989 (1979)CrossRefGoogle Scholar.

122 As it is argued that alcohol use “can be conceptualized as self-prescribed medication aimed at inhibiting deterioration of the user's mental health,” it is logical to assert that prescribed psychoactives can substitute for alcohol either as a recreational drug (rarely) or as a medication (frequently). See Crutchfield, & Gove, , Determinants of Drug Use: A Test of the Coping Hypotheses, 18 Soc. Sci. MED. 503 (1984)CrossRefGoogle Scholar.

123 One writer's list of the effects of mandatory prescription includes reinforcement of physicians’ medical monopoly, increased treatment costs, greater client dependency and an easier rationalization of “excessive drug use.” Layne, supra note 3, at 605.

124 Rosenberg observes that medical users of amphetamines “overlook the basic euphoria and sense of powerfulness that goes along with amphetamine use, believing instead that they are taking the amphetamine for weight reduction, or because the doctor prescribed it.” Rosenberg, The Abusers of Stimulants and Depressants, in Types of Drug Abusers and their Abuses 125 (J. Cull & R. Hardy eds. 1973).

125 Physicians enter practice “with limited training in the field of psychoactive substance abuse.” Smith & Seymour, Prescribing Psychoactive Drugs: A Question of Perspective, in J. Morgan, supra note 39, at 187; see also Grossman, & Sheidler, , Skills of Medical Students and House Officers in Prescribing Narcotic Medications, 60 J. Med. Educ. 552 (1985)Google Scholar; Gosney & Tallis, Prescription of Contraindicated and Interacting Drugs in Elderly Patients Admitted to Hospital, Lancet, Sept. 8, 1984, at 564.

126 P. Temin, supra note 1, at 9, 89, 119.

127 Id. at 88. As prescribing choices are based, in part, on custom, different countries naturally evidence variations in medical customs with respect to drugs. See Cooperstock, supra note 49, at 302.

128 For a discussion of the early legislative history of the Pure Food and Drug Act of 1906 and the lack of labeling/disclosure requirements, see Miller, Introduction to the Act and Dunn, Its Legislative History, Historic Meeting to Commemorate the Fortieth Anniversary of the Original Food and Drug Act 1-8, 10-27 (1946).

129 See generally M. Silverman, P. Lee & M. Lydecker, supra note 27, at 97-117; M. Muller, the Health of Nations 30-35 (1982).

130 Drug risks are intially underestimated because of universally incomplete testing. M. Mintz, supra note 47, at 2-7. To measure risks accurately long term effects must be assessed over several generations under real social conditions. Although certain drugs have been used for thousands of years, only in the last century have rudimentary steps been taken to competently measure drug effects. As a result, all current efforts at drug assessment are incomplete.

131 See the sources listed infra at note 136. On the legal standards of products liability generally, see Green, , Strict Liability under Sections 402A and 402B: A Decade of Litigation, 54 Tex. L. Rev. 1185 (1977)Google Scholar.

132 M. Silverman & P. Lee, supra note 103, at 289-90.

133 R. Mendelsohn, supra note 16, at 32.

134 According to one study, prescribing by pharmacists led to a reduction in the use of inappropriate or unnecessary drugs and a lower level of adverse drug reactions. Pharmacists’ drug advice is also considerably cheaper. Despite these and other similar results, physicians retain control. See McGhan & Stimmel, The Pharmacist as Prescriber, in J. Morgan, supra note 39, at 119 (citing McKenney, The Effect of Clinical Pharmacy Services on Patients with Essential Hypertension, 48 Circulation 1104-11 (1973)).

135 Layne, supra note 3, at 606.

136 See generally Pierce, , Encouraging Safety: The Limits of Tort Law and Government Regulation, 33 Vand. L. Rev. 1281 (1980)Google Scholar; Teff, supra note 62, at 114-15; Trebilcock, Regulating Service Quality in Professional Markets, and Hirshhorn, Regulating Quality in Product Markets in D.N. Dewees, supra note 8, at 83, 89, 55, 61.

137 Rosenberg, , The Causal Connection in Mass Exposure Cases: a “Public Law” Vision of the Tort System, 97 Harv. L. REV. 849, 852 (1984)CrossRefGoogle Scholar; W. Freedman, Products Liability 25-27 (1984).

138 Britain, , Product Honesty is the Best Policy: A Comparison of Doctors’ and Manufacturers’ Duty to Dischse Drug Risks and The Importance of Consumer Expectations in Determining Product Defect, 79 Nw. U. L. REV. 342, 369 (1984)Google Scholar. See generally Fern, & Sichel, , Evolving Tort Liability Theories: Are They Taking The Pharmaceutical Industry into An Era of Absolute Liability?, 29 St. Louis U. L. J. 763 (1985)Google Scholar; Epstein, The Legal and Insurance Dynamics of Mass Tort Litigation,]. Legal Stud. 475 (1984). In Epstein's article the liability of the prescriber is not even mentioned. Layne notes that responsibility for misuse of Rx drugs “does not fall squarely on either the physician's or the consumer's shoulders.” Layne, supra note 3, at 601.

139 Britain, supra note 138, at 368, 375 nn.134-37.

140 Lavigne, Pill warnings up to doctors, court told, Toronto Globe & Mail, Sept. 4, 1985, at 23.

141 Feedback on Prescribing, Lancet, ¥eb. 11, 1984, at 320. There is evidence that prescribing worsens physician-patient relations and that patients are more satisfied with information than with drugs. Wartman, , Do Prescriptions Adversely Affect Doctor-Patient Interactions?, 71 AM. J. PUB. Health 1358 (1981)CrossRefGoogle Scholar; see also S. Fredman & R. Burger, supra note 96, at 186. These authors claim that physicians are “eager to please,” that the impetus for over-prescribing comes from patients and that physicians give in because they lack “the time or ability to cure the psychosocial problems of their nonsick patients.” S. Fredman & R. Burger, supra. Legal analysts are similarly apologetic. Teff, for instance, declares that the invention of the benzodiazepines meant physicians “no longer felt compelled to prescribe barbiturates.” (emphasis added). Teff, , Products Liability in the Pharmaceutical Industry at Common Law, 20 Mcgill L. J. 102, 113 (1974)Google Scholar. Other researchers found that prescribing of psychoactive drugs was neither predictable nor based on client expectations. Hadsall, , Freeman, & Norwood, , Factors Related to the Prescribing of Selected Psychotropic Drugs by Primary Care Physicians, 16 Soc. Sci. MED. 1747 (1982)CrossRefGoogle Scholar.

142 For sources which discuss the relative safety of Rx only psychoactives, see those listed in Mitchell, supra note 61, at nn. 67-81.

143 Cooperstock, Some Comments on the Clinical Appropriateness of Prescribing Psychoactive Drugs, in J. Morgan, supra note 39, at 158 (citing Uhlenhuth, Batter & Lipman, Minor Tranquilizers: Clinical Correlates of Use in an Urban Population, 35 Archives Gen. Psych. 650-55 (1978)).

144 Id. (citing Tyrer, Rutherford, & Huggett, Benzodiazepine Withdrawal Symptoms and Propranolol, Lancet, March 1981, 520-22).

145 See H. Lewis & M. Lewis, supra note 21. One study found that one-half of the excessive-quantity prescriptions from one clinic were written by 3.4% of the physicians. M. Silverman & P. Lee, supra note 103, 296-98.

146 One psychiatrist worries that desperate clients denied Valium might “steal tranquilizers, or they might take to alcohol, or they might lose their jobs, their families, their dignity. It is the same dilemma we faced with alcohol during Prohibition.” S. Rosenblatt & R. Dodson, Beyond Valium—the Brave New World of Psychochemistry 210 (1981).

147 The legislative restriction of amphetamine prescription in Canada in the early 1970's resulted in a 90% decline in consumption. Cooperstock, supra note 49, at 302. On the U.S. situation, see E. Goode, supra note 47, at 46-54. S. Rosenblatt & R. Dodson, supra note 146, at 234.

148 Rabin discusses improvements in prescribing, such as more generics and fewer psychoactives but he does not clearly apportion responsibility for these improvements between “public concern” and physician enlightenment. Rabin, supra note 40, at 20-22.

149 U.S.C. §§ 801-960 (1982). This Act is found within the Comprehensive Drug Abuse Prevention and Control Act, supra note 92.

150 Anthony, , The Effects of Federal Drug Law on the Incidence of Drug Abuse, 4 J. Health Pol. Pol'y & L. 87 (1979)CrossRefGoogle Scholar; P.K. Manning, the Narcs’ Game—Organizational and Informational Limits on Drug Law Enforcement 6, 12 (1980).

151 21 U.S.C. § 812.

152 Id.

153 21 U.S.C. §§ 841-843.

154 U.S.C. §844.

155 21 U.S.C. § 812(1)(A)-(B).

156 21 U.S.C. § 812(2)(A).

157 See Grinspoon, In the Age of Cocaine—What is America's Drug Problem?, Harpers, Dec. 1985, 39, 44-45; E. Goode, supra note 47, at 11-12, 14; A. Helman, Law Against Marijuana—the Price we Pay 5-6 (1975).

158 Anthony, supra note 150, at 88-90; Wisotsky, Exposing the War on Cocaine: The Futility and Destructiveness of Prohibition, 1983 Wis. L. REV. 1305, 1308-09.

159 See, e.g., F.A. Whitlock, Drugs, Morality and the Law 129 (1975); A. Trebach, the Heroin Solution 289 (1982); Moore, Regulating Heroin: Kaplan and Trebach on the Dilemmas of Public Policy, Am. Bar Found. Res. J. 723, 724, 728 (1984).

160 Mitchell, supra note 61.

161 See Bonnie & Whitebread, supra note 64, at 990-1009 (the authors advocate a specifically enumerated constitutional right to consume any drug).

162 Mitchell, supra note 61, at 258-61.

163 S. Fredman & R. Burger, supra note 96, at 184.

164 Wertheimer claims that approximately 25% of all Rx drugs are psychoactive but, as Cooperstock demonstrates, a sizeable portion of Rx compounds contain “hidden psychoactives.” See Wertheimer, supra note 39, at 5; Cooperstock, supra note 49, at 304-05.

165 See generally S. Rachman & G. Wilson, the Effects of Psychological Therapy (1980); B. Zilbergeld, the Shrinking of America (1983); H.J. Eysench, the Effects of Psychotherapy (1969).

166 See Trebilcock & Shaul, Regulating the Quality of Psychotherapeutic Services, in D.N. Dewees, supra note 8, at 275-89.

167 Non-psychoactive substances exhibit these qualities by definition and by virtue of their lack of impact on the central nervous system. Any substance may function as a placebo to generate psychological satisfactions, thus any substance could serve as the focus of neurotic fixation. These effects are not drug specific, however, and must be carefully separated from inherent pharmaceutical or biological properties.

168 The alternatives to government intervention are industry self-regulation and private tort actions concerning defective products and failure to warn of inherent risks. Selfregulation is low cost but so unrestrictive as not to merit serious consideration. Tort actions could, theoretically, duplicate public regulation if transaction costs and information costs could be eliminated. In reality, tort actions are expensive and unreliable, and courts cannot create and administer the necessary regulatory framework to ensure production quality and marketing standards. See P. Schuck, Agent Orange on Trial—Mass Toxic Disasters in the Courts 278-97 (1986).

169 See generally Stigler, Regulation: The Confusion of Means and Ends, Regulating New Drugs 11 (R. Landau ed. 1973) [hereinafter cited as R. Landau]; Posner, Theories of Economic Regulation, Bell J. Econ. & Manag. 335 (1975); Trebilcock, Winners and Losers in the Modern Regulatory System: Must the Consumer Always Lose, 13 Osgoode Hall L. J. 627-28 (1975).

170 A number of authorities claim that the most significant cost of stringent regulation of new drug products is a slower rate of pharmaceutical innovation. See H. Grabowski 8C J. Vernon, the Regulation of Pharmaceuticals 5 (1982); Cooper, Purpose, Technique, and Strategy in tlie Regulation of New Drugs and Peltznian, The Benefits and Costs of New Drug Regulation, in R. Landau, supra note 169, at 22-23, 178-207. A cost-benefit analysis, however, is only as good as its facts, and many of these efforts are medically inaccurate. Typically, they overstate benefits and underreport costs. Peltznian, for example, assumed that the immediate symptom alleviation gained by analgesics like aspirin or tranquilizers like chlorpromazine are permanent. Peltznian, supra, at 178-84. Teff, likewise, claims without any evidence that the thalidomide tragedy “must be seen in the context of the countless modern synthetics which have saved lives and relieved pain on a vast scale.” Teff, supra note 62, at 145. For a counter argument that drug-induced comfort gains are balanced by equal, opposite discomforts, see D.G. Garan, supra note 28. As was noted earlier, the role played by anti-infectives in fighting disease is consistently exaggerated. See M. Silverman & P. Lee, supra note 103, at 282-92. See generally L. Lasagna, supra note 24.

171 Stigler argues that regulators are seldom experienced or knowledgeable enough to detect and prove violations. As usual, these deficiencies are created by structures that do not penalize failures or omissions and that do not objectively audit and assess the regulators. A possible solution is to legislate private incentives for enforcement. For example, private companies in clinical pharmacology could be rewarded for detecting violations by pharmaceutical producers. Such rewards could include a fixed “bounty” from the government or damages assessed against the violators. See Stigler, supra note 169, at 3.

172 Bloch argues that present systems are all inadequate because they do not provide for “better control of the part played by the physicians.” He claims that physicians lack an acceptable level of prescribing competence and calls for a special prescription license. He expects that better qualified physicians will help ensure that only safe, therapeutic drugs will reach the market. See Bloch, Toward Better Systems of Drug Regulation, in R. Landau, supra note 169, at 247. This analysis overlooks the demand for unsafe drugs and the incentive structure in which monopoly prescribers operate. I argue that better control is not realistically attainable. Therefore, the part played by physicians must be radically deregulated.

173 See Pearson, , Prescribing for the Elderly—An Audit 229 Practitioner 85 (1985)Google ScholarPubMed; P., Williams, Patterns of Psychotropic Drug Use, 17 Soc. Sci. MED. 845, 847, 849 (1983)Google Scholar.

174 Baron, supra note 5, at 347, 353, 355.

175 Prior to 1930, when almost all prescriptions were optional, approximately one-third of total drug sales were nonetheless purchased by prescription. Peltzman, supra note 3, at 6.

176 The World Health Organization estimates that of the 2000 primary drugs marketed, only 200 are indispensible for health care. Canadian Department of Industry, Trade and Commerce, the Health Care Products Industry in Canada 4 (1979) (Government of Canada, Discussion Paper). Collective action through nationalization and direct government supervision of drug production and prescription would likely result in a drastic reduction of the number of drug items produced. See Modr & Stika, Czechoslovakia, Controlling the use of Therapeutic Drugs—An International Comparison 237 (W. Wardell ed. 1978).

177 See Layne, supra note 3, at 604, 606. Fry estimates that 90% of primary health care can be appropriately handled to some degree by the individual. J. Fry, A New Approach To Medicine 127 (1978).

178 Some authorities claim that most patients consulting a GP have complaints that are either non-medical or non-treatable except by way of symptomatic relief that likely worsens the underlying cause in the long term. If physicians were strictly limited to treating patients to whom they could deliver a physical benefit, the impact would be devastating. There is no need to prohibit useless treatment where medical services are funded privately. A much different conclusion is warranted, though, when useless treatment is publicly funded. The public subsidy of useless medical care cannot be justified. See the sources listed at notes 23, 24, 30, 45, 48 supra.

179 Myers & Fink, Legal Considerations in Establishing Third and Fourth Classes of Drug Products, 31 Food Drug Cosm. L.J. 4-10 (1976).

180 Moore claims it “distresses” physicians to prescribe to opiate users who come seeking “not improvement, not a better life, not rehabilitation, but drugs to stick in their veins.” Accordingly, physicians should be equally distressed by the continued prescription of any psychoactive but such is not the case. See Moore, supra note 159, at 728.

181 Baron similarly argues that while repeal of medical licensure laws would spark “massive resistance from the medical profession,” individual physicians would benefit in the long run if such reform occurred. Baron, supra note 5, at 356.