An alternative: Homeopathic drugs, Royal Copeland, and Federal Drug Regulation

Food and Drug Law Journal

Volumn 55, Issue 1, 2000, Pages 161-183

  Junod, Suzanne White ^a  

^a CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

HOMEOPATHIC AGENT; NON PRESCRIPTION DRUG;

FOOD; FOOD AND DRUG ADMINISTRATION; GOVERNMENT; HOMEOPATHY; LAW; MEDICAL LITERATURE; MEDICAL SOCIETY; ORGANIZATION; REGULATORY MECHANISM; REVIEW; STANDARD; UNITED STATES; ALTERNATIVE MEDICINE; ARTICLE; DRUG CONTROL; HISTORY; HUMAN; POLITICS;

COMPLEMENTARY THERAPIES; DRUG AND NARCOTIC CONTROL; HISTORY, 20TH CENTURY; HOMEOPATHY; HUMANS; LEGISLATION; PHARMACOPOEIAS, HOMEOPATHIC; POLITICS; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 0033994426     PISSN: 1064590X     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Review

References (205)

1. Pub. L. No. 75-717, 52 Stat. 1040 (1938) (codified as amended at 21 U.S.C. §§ 301-392 (1994)).
2. 21 U.S.C. § 321(g) (FDCA § 201 (g)).
3. Throughout the twentieth century, drug standardization dramatically changed the regular practice of medicine. This change has been characterized by historian John Harley Warner as a shift from individualization in therapy during the nineteenth century, to universalism in the twentieth. Homeopathy, in contrast, maintained its devotion to individualized treatment regimes at least through the mid-twentieth century in the United States, leading many regular physicians to hold homeopathic practice in disdain. "Regressive" would have been one of the most complimentary terms used by skeptics to describe homeopathic practice. JOHN HARLEY WARNER, THE THERAPEUTIC PERSPECTIVE: MEDICAL PRACTICE, KNOWLEDGE, & IDENTITY IN AMERICA 1820-1885 161 (1986).
4. TREVOR M. COOK, SAMUEL HAHNEMANN: THE FOUNDER OF HOMEOPATHIC MEDICINE 15, 183 (1981).
5. NAOMI ROGERS, AN ALTERNATIVE PATH: THE MAKING AND REMAKING OF HAHNEMANN MEDICAL COLLEGE AND HOSPITAL OF PHILADELPHIA 6 (1998) [hereinafter ROGERS, HAHNEMANN MEDICAL].
6. Hahnemann reportedly was led to this view by observing that Peruvian bark and quinine cured malaria, but in large doses they mimicked the disease. See COOK, supra note 4, at 59.
7. The "causing provision" was the basis for criminal prosecutions against company officials and employees who "caused" illegal adulterations and misbranding of food and drug products under the law. Harding concluded that the causing provision was "very much in the mind of some member of the agency (FDA)." George E. Harding, 301(a): The "Causing" Provision and Jurisdictional Limits, 6 FOOD DRUG COSM. L.J. 597 (1951).
8. Id.
9. Food and Drugs Act, Pub. L. No. 59-384, 34 Stat. 768 (1906) (codified at 2) U.S.C. §§ 1-15 (1934)) (repealed in 1938 by 21 U.S.C. § 392(a)) (hereinafter "1906 Act").
10. Glenn Sonnedecker, Drug Standards Become Official, in THE EARLY YEARS OF FEDERAL FOOD & DRUG CONTROL 28, 28-39 (1982).
11. Legal standards for food products were not included in the 1906 Act, in part because there was no foods organization with the same status as the U.S. Pharmacopeial Convention. Suzanne White, Chemistry & Controversy: Regulating the Use of Chemicals in Foods, 1883-1959, (1994) (unpublished Ph.D. dissertation, Emory University) (on file with Woodruff Library, Emory University) at 255-60.
12. For discussion about debates concerning the authority and limits surrounding recognition of the NF and USP, see JAMES HARVEY YOUNG, PURE FOOD 207, 209 (1989).
13. This frequently is referred to as the "variation clause." For examples, see John P. Swann, Evolution of the Drug Label, 15 FOOD DRUG COSM. & MED. DEVICE L. DIGEST 23, 23-31 (1998).
14. A drug is defined as: 1) articles recognized in the official USP, official HPUS or official NF or any supplement to any of them; and 2) articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals; and 3) articles (other than food) intended to affect the structure or any function of the body of man or other animals; and 4) articles intended for use as a component of any article specified in clause 1, 2, or 3; but does not include devices or their components, parts, or accessories, 21 U.S.C. § 321(g) (FDCA § 201(g)).
15. YOUNG, supra note 12, at 265.
16. Royal Copeland, Speeches & Writings on Homeopathy, box 21, folder 6 (unpublished papers) (on file with the Bentley Historical Library, University of Michigan at Ann Arbor) [hereinafter Speeches & Writings].
17. Id.
18. Id. In the wake of the 1906 Act, most drugs came to be viewed as either ethical, quack, or proprietary. Labeling requirements led many "proprietary" drugs to change their labeling, their composition, or both. Reformed proprietary drugs occupied a perennial, but separate category preserving America's determination to self-medicate. Homeopathic drugs, however, blurred these distinctions and had a different history. Prescribed by educated physicians, "homeopathy was based on a scientific approach, an experimental pharmacology; in many ways it had a better claim to scientific accuracy than did the practice of bloodletting and the use of calomel." Martin Kaufman, Homeopathy in America: The Rise and Fall and Persistence of a Medical Heresy, in OTHER HEALERS: UNORTHUDOX MEDICINE IN AMERICA 99 (Norman Gevitz ed. 1988).
19. In the area of treatment, the "new homeopaths" sought to modify a central tenet of traditional homeopathic medical practice - its adherence to highly individualized and personalized therapy. The acceptance of the HPUS and the need for drug standardization after the 1906 Act was enacted reflects not only the central role of therapy in homeopathic practice, but the degree with which the "new homeopaths" supported the "scientific" goal of gaining greater precision in therapeutic practice. ROGERS, HAHNEMANN MEDICAL, supra note 5, at 83.
20. Naomi Rogers American Homeopathy Confronts Scientific Medicine, in CULTURE, KNOWLEDGE AND HEALING: HISTORICAL PERSPECTIVES OF HOMEOPATHIC MEDICINE IN EUROPE AND NORTH AMERICA 31-64 (Juette, Risse & Woodward eds. 1998) [hereinafter Rogers, HISTORICAL PERSPECTIVES].
21. Raymond Joseph Potter, Royal Samuel Copeland 1868-1938: A Physician in Politics, (1967) (unpublished Ph.D. dissertation, University of Cleveland) (on file with University Microfilms). This biography is the only full length work on Copeland.
22. Id. at 21, 24.
23. See id. at 24.
24. ROGERS, HAHNEMANN MEDICAL, supra note 5, at 65; JOHN HARLEY WARNER, AGAINST THE SPIRIT OF SYSTEM: THE FRENCH IMPULSE IN NINETEENTH CENTURY AMERICAN MEDICINE (1998); Potter, supra note 22, at 30.
25. ROGERS, HAHNEMANN MEDICAL, supra note 5, at 65; JOHN HARLEY WARNER, AGAINST THE SPIRIT OF SYSTEM: THE FRENCH IMPULSE IN NINETEENTH CENTURY AMERICAN MEDICINE (1998); Potter, supra note 22, at 30.
26. ROGERS, HAHNEMANN MEDICAL, supra note 5, at 65; Potter, supra note 22, at 29-31. Like many homeopaths, Copeland pursued specialist training in Europe, rather than additional homeopathic training.
27. ROGERS, HAHNEMANN MEDICAL, supra note 5, at 65; Potter, supra note 22, at 29-31. Like many homeopaths, Copeland pursued specialist training in Europe, rather than additional homeopathic training.
28. For a discussion of the evolution of Ophthalmology, Optometry, and the AMA's first specialty board, the American Board for Ophthalmic Examinations, see ROSEMARY STEVENS, AMERICAN MEDICINE AND THE PUBLIC INTEREST 98-114 (1998). Rogers notes that a group of homeopathic eye, ear, and throat specialists organized in 1877, publishing their own set of Transactions, later renamed the HOMEOPATHIC EYE, EAR, & THROAT J. In 1889, a separate homeopathic organization began publishing the J. OPTHAMOLOGY, OTOLOGY, & LARYNGOLOGY. It was this latter group with which Copeland was associated. In 1910, the journals merged.
29. Naomi Rogers, The Public Face of Homeopathy in the US 1900-1950, Address at the Second International Conference on History of Homeopathy, Bosch Institute, Stuttgart (July 1999) at 6, n.13.
30. Id. at 80.
31. In 1895, the AIH rewrote its official definition of a homeopathic physician as "one who adds to his knowledge of medicine a special knowledge of homeopathic therapeutics." Copeland accepted, elaborated on, and ultimately embodied this vision of his profession.
32. Potter, supra note 22, at 35, 41.
33. Id. at 35.
34. In Defense of the Attenuated Drug, Homeopathic Medical Society of the State of Ohio, Speeches & Writings, supra note 16, box 7 (May 10-11, 1904).
35. Id., box 21. In 1899, the AIH accepted a new consensus that envisioned homeopathy as a complementary, rather than an alternative medical profession. ROGERS, HAHNEMANN MEDICAL, supra note 5, at 85. Copeland was elaborating on the thinking that had gone into the passage of the resolution. For an account of similar reformist thinking in Britain, see GLYNIS RANKIN, Professional Organization & the Development of Medical Knowledge: Two Interpretations of Homeopathy, in STUDIES IN THE HISTORY OF ALTERNATIVE MEDICINE 46-62 (Roger Cooter ed. 1988).
36. Id., box 21. In 1899, the AIH accepted a new consensus that envisioned homeopathy as a complementary, rather than an alternative medical profession. ROGERS, HAHNEMANN MEDICAL, supra note 5, at 85. Copeland was elaborating on the thinking that had gone into the passage of the resolution. For an account of similar reformist thinking in Britain, see GLYNIS RANKIN, Professional Organization & the Development of Medical Knowledge: Two Interpretations of Homeopathy, in STUDIES IN THE HISTORY OF ALTERNATIVE MEDICINE 46-62 (Roger Cooter ed. 1988).
37. REFERENCE HANDBOOK OF THE MEDICAL SCIENCES, Speeches & Writings, supra note 16, box 21.
38. Id.
39. See, e.g., OLIVER WENDELL HOLMES, HOMEOPATHY & ITS KINDRED DELUSIONS (1899); KAUFMAN, supra note 18.
40. Homeopathy: Much Ado About Nothing, CONSUMER REP. 59, 201 (Mar. 1994); Homeopathy, MEDICAL LETTER ON DRUGS AND THERAPEUTICS, 41, 20-21 (Feb. 26, 1999).
41. Homeopathy: Much Ado About Nothing, CONSUMER REP. 59, 201 (Mar. 1994); Homeopathy, MEDICAL LETTER ON DRUGS AND THERAPEUTICS, 41, 20-21 (Feb. 26, 1999).
42. Kaufman notes that it was difficult to practice classical homeopathy by the end of the nineteenth century, so some homeopaths "simplified their work and bolstered their income by using allopathic remedies and by increasing the dosage of their homeopathic treatments." In short, "it was much easier to be an allopath, relying upon a specific remedy for each ailment." KAUFMAN, supra note 18, at 106.
43. REFERENCE HANDBOOK OF THE MEDICAL SCIENCES 294, Speeches & Writings, supra note 16, box 21.
44. Potter, supra note 22, at 33.
45. In 1899, the AIH redefined homepathy's law of similars as "let like be cured by like," and made it "less a law than a guide to therapy." ROGERS, HAHNEMANN MEDICAL, supra note 5, at 85. Copeland refers to it as a "hypothesis." REFERENCE HANDBOOK OF THE MEDICAL SCIENCES 294, Speeches & Writings, supra note 16, box 21.
46. In 1899, the AIH redefined homepathy's law of similars as "let like be cured by like," and made it "less a law than a guide to therapy." ROGERS, HAHNEMANN MEDICAL, supra note 5, at 85. Copeland refers to it as a "hypothesis." REFERENCE HANDBOOK OF THE MEDICAL SCIENCES 294, Speeches & Writings, supra note 16, box 21.
47. REFERENCE HANDBOOK OF THE MEDICAL SCIENCES 294, Speeches & Writings, supra note 16, box 21.
48. Id.
49. Id.
50. Id.
51. Id.
52. Id.
53. JAMES HARVEY YOUNG, THE TOADSTOOL MILLIONAIRES: A SOCIAL HISTORY OF PATENT MEDICINES IN AMERICA BEFORE FEDERAL REGULATION (1961). Homeopaths struggled with the issue of homeopathic patent medicines. ROGERS, HAHNEMANN MEDICAL, supra note 5, at 42-44.
54. JAMES HARVEY YOUNG, THE TOADSTOOL MILLIONAIRES: A SOCIAL HISTORY OF PATENT MEDICINES IN AMERICA BEFORE FEDERAL REGULATION (1961). Homeopaths struggled with the issue of homeopathic patent medicines. ROGERS, HAHNEMANN MEDICAL, supra note 5, at 42-44.
55. Charles S. Cameron, M.D., Homeopathy in Retrospect, TRANSACTIONS AND STUDIES OF THE COLLEGE OF PHYSICIANS IN PHILADELPHIA, at 29 (July 1959) (noting that homeopaths did pioneering work in drug therapy with the insane and helped simplify prescriptions).
56. Mark Sullivan, The Patent Medicine Conspiracy Against the Freedom of the Press, COLLIER'S MAG. 13-16 (Nov. 3, 1905); SAMUEL HOPKINS ADAMS, THE GREAT AMERICAN FRAUD (1906); YOUNG, supra note 49, at 197.
57. Mark Sullivan, The Patent Medicine Conspiracy Against the Freedom of the Press, COLLIER'S MAG. 13-16 (Nov. 3, 1905); SAMUEL HOPKINS ADAMS, THE GREAT AMERICAN FRAUD (1906); YOUNG, supra note 49, at 197.
58. What is Homeopathy?, Speeches & Writings, supra note 16, box 21, folder 2.
59. Id.
60. Id.
61. Id.
62. Id., box 21, folders 2, 6. In 1902, the First International Agreement for the Unification of the Formulas for Potent Drugs was adopted and ratified. C.H. Hampshire, League of Nations Bulletin of the Health Organization, 12 112-79 (1945-46), as quoted in George Urdang, The Development of Pharmacopeias, 8 FOOD DRUG & COSM. L.J. 90, note 12 (1953).
63. Id., box 21, folders 2, 6. In 1902, the First International Agreement for the Unification of the Formulas for Potent Drugs was adopted and ratified. C.H. Hampshire, League of Nations Bulletin of the Health Organization, 12 112-79 (1945-46), as quoted in George Urdang, The Development of Pharmacopeias, 8 FOOD DRUG & COSM. L.J. 90, note 12 (1953).
64. Homeopathy in the Twentieth Century, Speeches & Writings, supra note 16, box 21, folder 1 (May 21, 1901).
65. Potter, supra note 22, at 91-94; Homeopathy & Posology, Speeches & Writings, supra note 16, box 21, folder 6.
66. Sonnedecker, supra note 10, at 35.
67. SUSAN E. LEDERER, SUBJECTED TO SCIENCE: HUMAN EXPERIMENTATION IN AMERICA BEFORE THE SECOND WORLD WAR 52-53 (1995). After criticizing Gallinger's medical credentials and his opposition to the Owens Bill, the Children's Bureau, and "anything endorsed by the AMA," an editorialist quipped: "[n]obody takes Senator Gallinger seriously as a senator. Why not let him strut about as an authority on medical subjects?" Editorial, Old Doc Gallinger, 62 JAMA 1354-55 (1914).
68. SUSAN E. LEDERER, SUBJECTED TO SCIENCE: HUMAN EXPERIMENTATION IN AMERICA BEFORE THE SECOND WORLD WAR 52-53 (1995). After criticizing Gallinger's medical credentials and his opposition to the Owens Bill, the Children's Bureau, and "anything endorsed by the AMA," an editorialist quipped: "[n]obody takes Senator Gallinger seriously as a senator. Why not let him strut about as an authority on medical subjects?" Editorial, Old Doc Gallinger, 62 JAMA 1354-55 (1914).
69. Sonnedecker, supra note 10, at 35; GUIDE TO RECORDS OF US SENATE AT THE NATIONAL ARCHIVES (1789-1989) 266 (1989).
70. Id.
71. Rogers, supra note 28, at 27, 90. Copeland's papers reveal that he was in a strong position during and after Abraham Flexner's visit to the institution. While he disagreed with Flexner's views about homeopathy, he approved of Flexner's overall objectives. In addition, he heeded many of Flexner's suggestions including the admonition to strengthen research at the institution. In response, alumni promptly contributed $9000 of $10,000 needed to erect a new bacteriological laboratory. In 1911 Copeland's contract was renewed for $9000 a year. Potter, supra note 22, at 123.
72. Abraham Flexner, Report on Medical Education in the U.S. and Canada: A Report to the Carnegie Foundation for the Advancement of Teaching, 159-61 (1910).
73. Id.
74. The Future of Homeopathy, Speeches & Writings, supra note 16, note 16, box 21, at 4.
75. Copeland essentially was commandeered in 1918 to serve as New York City's Health Commissioner by the city's mayor. Potter, supra note 22, at 140.
76. Correspondence to Rita E. Dunlevy, May 9, 1918, Speeches & Writings, supra note 16, box 22; see also id., New York Board of Health, Saving the Babies in a Great City.
77. Potter, supra note 22, at 214-15.
78. Id.
79. U.S. Senate, Food and Drugs, The Health of the Nation, Speeches & Writings, supra note 16, box 25, at 7.
80. Potter, supra note 22, at 96, 275.
81. U.S. Senate, Food and Drugs, Text of National Cosmetic Bill Sept. 1927, Speeches & Writings, supra note 16, box 25; Gwen E. Kay, Regulating Beauty: Cosmetics in American Culture from the 1906 Pure Food and Drugs Act to the 1938 Food, Drug, and Cosmetic Act (1997) (unpublished Ph.D. Thesis, Yale University) (on file with Yale University); JAMES HARVEY YOUNG, THE MEDICAL MESSIAHS 164 (1967); CHARLES O. JACKSON, FOOD & DRUG LEGISLATION IN THE NEW DEAL 14 (1970); Potter supra note 22, at 153.
82. U.S. Senate, Food and Drugs, Text of National Cosmetic Bill Sept. 1927, Speeches & Writings, supra note 16, box 25; Gwen E. Kay, Regulating Beauty: Cosmetics in American Culture from the 1906 Pure Food and Drugs Act to the 1938 Food, Drug, and Cosmetic Act (1997) (unpublished Ph.D. Thesis, Yale University) (on file with Yale University); JAMES HARVEY YOUNG, THE MEDICAL MESSIAHS 164 (1967); CHARLES O. JACKSON, FOOD & DRUG LEGISLATION IN THE NEW DEAL 14 (1970); Potter supra note 22, at 153.
83. U.S. Senate, Food and Drugs, Text of National Cosmetic Bill Sept. 1927, Speeches & Writings, supra note 16, box 25; Gwen E. Kay, Regulating Beauty: Cosmetics in American Culture from the 1906 Pure Food and Drugs Act to the 1938 Food, Drug, and Cosmetic Act (1997) (unpublished Ph.D. Thesis, Yale University) (on file with Yale University); JAMES HARVEY YOUNG, THE MEDICAL MESSIAHS 164 (1967); CHARLES O. JACKSON, FOOD & DRUG LEGISLATION IN THE NEW DEAL 14 (1970); Potter supra note 22, at 153.
84. U.S. Senate, Food and Drugs, Text of National Cosmetic Bill Sept. 1927, Speeches & Writings, supra note 16, box 25; Gwen E. Kay, Regulating Beauty: Cosmetics in American Culture from the 1906 Pure Food and Drugs Act to the 1938 Food, Drug, and Cosmetic Act (1997) (unpublished Ph.D. Thesis, Yale University) (on file with Yale University); JAMES HARVEY YOUNG, THE MEDICAL MESSIAHS 164 (1967); CHARLES O. JACKSON, FOOD & DRUG LEGISLATION IN THE NEW DEAL 14 (1970); Potter supra note 22, at 153.
85. David F. Cavers, The Food, Drug, and Cosmetic Act of 1938: Its Legislative History and Its Substantive Provisions, 6 J.L. & CONTEMP. PROBS. 10 (1939).
86. Interview between Charles O. Jackson and Rexford G. Tugwell, June 7, 1968, FDA Oral History Collection, National Library of Medicine; 73 CONG. REC. S1944 (1933); see infra note 106.
87. Wallace F. Janssen, Propaganda Guns Try to Force Tugwell Bill Passage, GLASS PACKER 760-62 (Dec. 3, 1933). Cavers notes that "Tugwellomania" became an industrial disease around this time. The symptoms he characterized as "cold feet, red spots before the eyes, a loss of the sense of proportion and delusions of persecution." David Cavers, Tugwellomania, 9 FOOD INDUSTRIES 2 (1934); JACKSON, supra note 73, at 36.
88. Wallace F. Janssen, Propaganda Guns Try to Force Tugwell Bill Passage, GLASS PACKER 760-62 (Dec. 3, 1933). Cavers notes that "Tugwellomania" became an industrial disease around this time. The symptoms he characterized as "cold feet, red spots before the eyes, a loss of the sense of proportion and delusions of persecution." David Cavers, Tugwellomania, 9 FOOD INDUSTRIES 2 (1934); JACKSON, supra note 73, at 36.
89. Food, Drugs, and Cosmetics, Hearings on S. 1944 Before the Senate Comm. on Commerce, 73d Cong., 2d Sess. (1933) [hereinafter Senate Hearings].
90. Copeland, as NYC Health Commissioner, had been forced to work around the deficiencies in the 1906 Act, including the absence of federal food standards which forced local jurisdictions to formulate their own legal standards. U.S. Senate, Food and Drugs, The Health of the Nation, Speeches & Writings, supra note 16, box 25, at 5-6.
91. 78 CONG. REC. 5: 5467-73 (1934).
92. Public Statement, Speeches & Writings, supra note 16, box 21, folder 1, at 4.
93. Id. at 7.
94. It is likely that this was a proposal submitted to Copeland by the homeopathic profession. It is unlikely that Copeland was in close enough touch with homeopathic organizations to have authored this provision himself, at this time.
95. Senate Hearings, supra note 77, at 4.
96. Id.
97. YOUNG, supra note 49, at 164; JACKSON, supra note 73, at 27.
98. "Demonstrable scientific facts" appears in Copeland's statement introducing S 2000. U.S. Senate, Food and Drug, Senator Copeland's Statement About New Food and Drug Bill, Speeches & Writings, supra note 16, box 25.
99. Senate Hearings, supra note 77, at 12. In the FDCA, therapeutic devices specifically were covered and subjected to the same general requirements as established for drugs. Drugs or devices deemed dangerous to health under the conditions of use prescribed in the labeling were prohibited from interstate commerce. 21 U.S.C. §§ 321, 352 (FDCA §§ 201(g)(2), (3), 502(j)).
100. U.S. Senate, Food and Drug, Why Submitted Section 4(e) Should Be Included in Any Food and Drug Bill, Speeches & Writings, supra note 16, box 25 (Dec. 19, 1933).
101. Id.
102. Id.
103. Id.
104. Id. Although this charge cannot be substantiated, the headache remedies employing various ingredients were troublesome products for early drug regulators. YOUNG, supra note 49, at 1-14; CHARLES C. MANN & MARK L. PLUMMER, THE ASPIRIN WARS: MONEY, MEDICINE & 100 YEARS OF RAMPANT COMPETITION 123-37 (1991).
105. U.S. Senate, Food and Drug, Why Submitted Subsection (e) Should Be Included in Any Food and Drug Bill, Speeches & Writings, supra note 16, box 25.
106. NORMAN GEVITZ, OTHER HEALERS: UNORTHODOX MEDICINES AMERICA 94, 136, 168 (1988); WILLIAM G. ROTHSTEIN, AMERICAN MEDICAL SCHOOLS & THE PRACTICE OF MEDICINE 153-59 (1987); KEN M. LUDMERER, LEARNING TO HEAL: THE DEVELOPMENT OF AMERICAN MEDICAL EDUCATION 88 (1985).
107. NORMAN GEVITZ, OTHER HEALERS: UNORTHODOX MEDICINES AMERICA 94, 136, 168 (1988); WILLIAM G. ROTHSTEIN, AMERICAN MEDICAL SCHOOLS & THE PRACTICE OF MEDICINE 153-59 (1987); KEN M. LUDMERER, LEARNING TO HEAL: THE DEVELOPMENT OF AMERICAN MEDICAL EDUCATION 88 (1985).
108. NORMAN GEVITZ, OTHER HEALERS: UNORTHODOX MEDICINES AMERICA 94, 136, 168 (1988); WILLIAM G. ROTHSTEIN, AMERICAN MEDICAL SCHOOLS & THE PRACTICE OF MEDICINE 153-59 (1987); KEN M. LUDMERER, LEARNING TO HEAL: THE DEVELOPMENT OF AMERICAN MEDICAL EDUCATION 88 (1985).
109. It is interesting to speculate as to the effect of this provision had it been enacted. In 1935, the AMA Council on Medical Education and Hospitals voted to exclude the graduates of "sectarian" institutions from hospital internships. Rather than having its students excluded, most institutions quickly dropped their sectarian affiliations. New York Homeopathic Medical College, for example, became New York Medical College. KAUFMAN, supra note 18, at 177; ROGERS, HAHNEMANN MEDICAL, supra note 5, at 129-32.
110. Senate Hearings, supra note 77 at 5: 5467-73.
111. It is not clear how Copeland arrived at his proposal or even that he, rather than FDA, initiated insertion of the HPUS into the law. American Institute of Homeopathy, Speeches and Writings, supra note 16, box 21, folder 6.
112. James Harvey Young & Richard E. McFadyen, The Koch Cancer Treatment, 53 J. HIST. MED. 255 (1998).
113. Id. at 258.
114. The Sherley Amendment required FDA to demonstrate fraudulent intent in the marketing of a drug.
115. Young & McFadyen, supra note 98, at 264.
116. The Koch papers, cited by Young and McFadyen, cannot be located in the federal records system for verification.
117. It would be difficult, if not impossible, to devise a legally accurate label for such a dilute preparation. If the product listed an active ingredient and such an ingredient could not be detected in the preparation, the product would be illegal. Likewise, the product could not meet the law's requirement to specify its own standard on the label if the concentration of its active ingredient could not be defined or verified.
118. Speeches & Writings, supra note 16, box 25 (Dec. 19, 1933).
119. Copeland noted that "the original bill which I presented met with violent opposition from every section of the country . . ." 78 CONG. REC. 59 (Jan. 4, 1934) in CHARLES WESLEY DUNN, FEDERAL FOOD, DRUG, & COSMETIC ACT: A STATEMENT OF ITS LEGISLATIVE RECORD 51 (1938). "[T]he discretionary power of S. 1944 was a fearful thing." JACKSON, supra note 73, at 34.
120. Senate Hearings, supra note 77, at 121 (indicating that these were considered "emergency" provisions). S. 1944 stated that a drug would be deemed adulterated where it purports to be a USP or NF drug "except that whenever tests or methods of assay have not been prescribed therein or such tests or methods of assay as are prescribed are found by the Secretary to be insufficient, he is hereby authorized to prescribe by regulations, tests, or methods of assay for determining whether or not such drug complies with such standards." A LEGISLATIVE HISTORY OF THE FEDERAL FOOD, DRUG, AND COSMETIC ACT 5 (vol. 1, 1979) [hereinafter LEGISLATIVE HISTORY].
121. It remained in S 2000, but was subject to the regulatory restrictions enumerated in a new section 22 of the bill that would have required all regulations to be recommended by an "appropriate committee." LEGISLATIVE HISTORY, supra note 106, at 601, 629.
122. In recent time, however, the NIH does seem to have enjoyed some degree of success with its "Consensus Conferences."
123. The Tugwell Bill: An Analysis and Proposed Amendments, Speeches & Writings, supra note 16, box 25, at 7-8. Analysis of section 8 (a)(2) recommended striking it, "There is in fact, and as a matter of common knowledge no such thing as 'general agreement of medical opinion' and there is no recorded case in legal history where there has ever been established a 'consensus' or 'general agreement of medical opinion' on any subject." Id.
124. Id.
125. Id.
126. Sonnedecker, supra note 10, at 35. Section 7, part 2 defined a drug as adulterated "[i]f its strength or purity fall below the professed standard or quality under which it is sold."
127. JACKSON, supra note 73, at 196. Nonofficial drugs were illegal unless their labels listed all active ingredients.
128. Oral Interview between Charles O. Jackson and Morris Fishbein, Mar. 12, 1968, FDA Oral History Collection, National Library of Medicine, 59, 84, 85.
129. Both regular and homeopathic physicians were opposed to osteopaths, chiropractors, and Christian Science healers. Copeland referred to these groups as "drugless" healers. KAUFMAN, supra note 18, at 114.
130. David F. Cavers, LEGISLATIVE HISTORY, supra note 76, at 10.
131. In the 1930s homeopaths still left their training with an "alternative identity: a feeling that they were distinct from but not entirely outside the medical mainstream." ROGERS, supra note 5, at 81.
132. Attrition and Homeopathy, Speeches & Writings, supra note 16, box 21, folder 5. In 1903, the AMA Code of Ethics was revised to allow homeopaths to become members of the AMA because both regular and homeopathic physicians were united in opposition to osteopaths, chiropractors, and Christian Science healers. ROGERS, HAHNEMANN MEDICAL, supra note 5, at 85.
133. Attrition and Homeopathy, Speeches & Writings, supra note 16, box 21, folder 5. In 1903, the AMA Code of Ethics was revised to allow homeopaths to become members of the AMA because both regular and homeopathic physicians were united in opposition to osteopaths, chiropractors, and Christian Science healers. ROGERS, HAHNEMANN MEDICAL, supra note 5, at 85.
134. HENRY E. SIGERIST, AMERICAN MEDICINE 196 (1934).
135. Suzanne White, Enforcing the 1938 Food, Drug, and Cosmetic Act: The Class of '39, 52 J. ASSOC. FOOD & DRUG OFFICIALS 18-19 (Oct. 1988).
136. JACKSON, supra note 73, at 196.
137. Young & McFadyen, supra note 98, at 266-67.
138. JACKSON, supra note 73, at 153-71.
139. In 1937, a company marketing a liquid preparation of the wonder drug sulfanilamide used diethylene glycol, a poison, as a solvent for the drug. Before an effective recall could be instituted, over 109 people died. The tragedy helped gain congressional support for enactment of the new food and drug statute. JAMES HARVEY YOUNG, Sulfanilamide & Diethylene Glycol, in CHEMISTRY AND MODERN SOCIETY: HISTORICAL ESSAYS IN HONOR OF AARON J. IHDE 105-25 (John Parascandola & James C. Whorton ed. 1983).
140. John P. Swann, FDA & the Practice of Pharmacy: Prescription Drug Regulation to 1951, 36 PHARMACY IN HIST. 55-70 (1994); see also Harry Marks, Revisiting the Origins of Compulsory Drug Prescriptions, 85 AM. J. PUBLIC HEALTH 109-15 (1995); Humphrey-Durham Drug Prescription Act, ch. 578, 65 Stat. 648 (21 U.S.C. §§ 333, 353 (1951)).
141. John P. Swann, FDA & the Practice of Pharmacy: Prescription Drug Regulation to 1951, 36 PHARMACY IN HIST. 55-70 (1994); see also Harry Marks, Revisiting the Origins of Compulsory Drug Prescriptions, 85 AM. J. PUBLIC HEALTH 109-15 (1995); Humphrey-Durham Drug Prescription Act, ch. 578, 65 Stat. 648 (21 U.S.C. §§ 333, 353 (1951)).
142. Administration Information Letter No. 269, July 3, 1953, 500.13 (homeopathic drugs are classified as prescription drugs under the Durham-Humphrey Amendment).
143. Id.
144. R.E. Hamilton to Standard Homeopathic (Nov. 20, 1970), FDA General Correspondence Files, 88-87-7, box 44, folder 239, decimal 546.
145. "Caution: Federal law prohibits dispensing without a prescription."
146. On file with the FDA History Office, Rockville, MD.
147. Homeopathy File, FDA History Office, Rockville, MD; Pub. L. No, 87-781, 76 Stat. 780 (1962) (21 U.S.C. §§ 321 et seq).
148. Id.
149. In 1978, Congress included a provision that would have eliminated recognition of the HPUS in the FDCA as part of a larger reform package, but the bill was not enacted. Elimination of the HPUS could have allowed the agency to reconsider subjecting homeopathic drugs to the efficacy provision of the law.
150. Pinco to Acting Director, Division of Data Management (May 28, 1974) GC 1980, 546, box 44, folder 239; Apodaca to Director, Division of Drug Labeling Compliance (Nov. 20, 1975) GC 546, box 44, folder 239.
151. Lamar, Memorandum of Conference (Sept. 8, 1971) 88-87-7, GC 1980 546 American Institute of Homeopathy, box 44, folder 239.
152. John P. Swann, Sure Cure: Public Policy on Drug Efficacy before 1962, in THE INSIDE STORY OF MEDICINES: A SYMPOSIUM 223-61 (Gregory J. Higby & Elaine C. Stroud eds. 1997).
153. 37 Fed. Reg. 3176 (Feb. 12, 1972). Peter Barton Hutt and Commissioner Edwards felt, at the time, that FDA probably never would institute an OTC review of homeopathic preparations. Personal conversation between the author and Mr. Hutt (June 1999).
154. Walters, Memorandum of Conference (Feb. 17, 1972) GC 1980, 88-87-7, 546, box 44, folder 239.
155. Officials felt that OTC labeling indicated that they were marketed "generally for use in conditions which the layman may be able to recognize," Packscher to Sansbury (Dec. 3, 1971) 88-87-7, GC 546, box 44, folder 239.
156. Kilburn to Hueper (July 19, 1971) 88-87-7, GC 1980, box 44, folder 239.
157. Meserey v. United States, 447 E Supp. 548 (D.Nev. 1977).
158. 37 Fed. Reg. 9464 (May 11, 1972).
159. RIMA D. APPLE, VITAMANIA: VITAMINS IN AMERICAN CULTURE 139-43 (1996).
160. Personal conversation between the author and Peter Barton Hutt (June, 1999); see also MARTIN KAUFMAN, HOMEOPATHY IN AMERICA 183 (1971).
161. Riding the Coattails of Homeopathy's Revival, FDA CONSUMER, 30-31 (Mar. 30 1985).
162. Loftus to Cloninger (June 4, 1971) 88-87-7, GC 1980, box 44, folder 239; ROGERS, HAHNEMANN MEDICAL, supra note 5, at 161.
163. American Homeopath 1 (May 1981) cited in KAUFMAN, supra note 18, at 118.
164. FDA CONSUMER, supra note 145, at 32; KAUFMAN supra note 18, at 18; Chastoney to District Directors (Nov. 6, 1981) GC 1983, 88-89-16, box 33, folder 180, Decimal 546.
165. Homeopathic Medications Available in More Than Half of Major Chains, F-D-C REP. ("The Tan Sheet"), Mar. 20, 1995, at 16.
166. Michels to Associate Commission for Regulatory Affairs (Nov. 27, 1984) 88-89-16, GC 1987, box 33, folder 180, decimal 546.
167. Concerns about lay homeopathy in the late 1970s and early 1980s led dissidents to form anew American Center for Homeopathy. Their newsletter, The American Homeopath, edited by Harris Coulter, argued in favor of self-medication in homeopathy. Questions about lay homeopathy "continue[] to pose a serious problem." KAUFMAN, supra note 18, at 115-16.
168. HPUS Update, HOMEOPATHY TOIMY 3-4 (June 1984).
169. In the wake of Hecker v. Chaney, FDA began to rely increasingly on Compliance Policy Guides as a means of expressing and exercising its regulatory "discretion," Suzanne White Junod, Valor and the Judicious Exercise of Discretion, 4 FDLI UPDATE 9 (Aug. 1999).
170. "For use under supervision of a licensed practitioner experienced in the use and administration of homeopathic drugs and familiar with indications, effects, dosages, methods, and frequency of duration of such drugs." FDA Compliance Policy Guide, Sec. 400.400, "Conditions Under Which Homeopathic Drugs May Be Marketed," CPG 7132.15 [hereinafter FDA Guide].
171. Wyrth Baker, M.D., to Jerome Halperin, Dep. Director, Bureau of Drugs (Nov. 4, 1981) 88-89-16, GC 1983, box 33, folder 180, decimal 546; Isadora Stehlin, Homeopathy: Real Medicine or Empty Promises?, FDA CONSUMER, Dec. 1996, at 18.
172. FDA Talk Paper on Homeopathy, Sept. 1988, available at FDA Press Office.
173. FDA Guide, supra note 154.
174. Id.
175. Homeopathic Indications Based on Conventional Efficacy Criteria Urged, F-D-C REP. ("The Tan Sheet"), Mar. 20, 1995, at 15-16.
176. It was made even more popular recently by publication in the British Medical Journal of a study indicating possible usefulness in primary fibromyalgia, a common rheumatic disease. P. Fisher, A. Greenwood, E.C. Huskisson, P. Turner & P. Belon, Effect of Homeopathic Treatment on Fibrositis, 299 BRIT. MED. J. 365-66 (1989).
177. License # 392; Public Health Service Act, 42 U.S.C. § 262 (1994).
178. FDA ANN. REP. 1950-1974 (1976), 813, 856-57.
179. 50 Fed. Reg. 3270 (Jan. 23, 1985).
180. Id.
181. Id.
182. Public Health Service Act, 42 U.S.C. § 262.
183. OTC Homeopathic Drugs Safety andEfficacy Review by FDA Urged, F-D-C REP., Sept. 19, 1994, at 16.
184. News Release (Aug. 29, 1994), Stephen Barrett, M.D., Homeopathy Files, FDA History Office, Rockville, MD.
185. The National Council Against Health Fraud reported that a November 1997 survey showed that forty-two percent of the survey's 1500 respondents had used some form of alternative health care in the past year. The most widely reported alternative therapy was self-treatment with herbal therapies (seventeen percent), but a close second was the use of professional chiropractors (16.6%). The Council noted that this showed at least a six percent increase over survey results of chiropractic usage in previous years. This growth in chiropractic use may be linked to increased interest in homeopathy because chiropractors are the most common practitioners of homeopathy, constituting about 18,500 practitioners in 1993. NAT'L COUNCIL AGAINST HEALTH FRAUD NEWSL. (Mar./ Apr. 1998).
186. Greg Plotnikoff, Complementary & Alternative Medicine, 3 BIOETHICS EXAMINER 1 (MAR. 1999).
187. Robert G. Pinco & Paul D. Rubin, Homeopathic Drugs: What are They, and How are They Regulated in the United States & in the European Union?, 14 BIOLOGICAL THERAPY 140 (Jan. 1996).
188. Homeopathy: Much Ado About Nothing, supra note 38, at 201; Steven Barrett, The Unethical Behavior of Pharmacists: How to Market Dubious Supplements & Unproven Remedies, 15 NUTRITION FORUM 1 (Jan/Feb. 1998); Terry Toy, Take Two Eyes of Newt and Call Me in the Morning, BUS. WK., Mar. 28, 1994, at 144; Dan McGraw, Flu Symptoms - Try Duck, U.S. NEWS & WORLD REP. Feb. 17, 1997, at 51; Martin Kaufman, Homeopathy in America, LANCET 120-23 (Oct. 18, 1986).
189. Homeopathy: Much Ado About Nothing, supra note 38, at 201; Steven Barrett, The Unethical Behavior of Pharmacists: How to Market Dubious Supplements & Unproven Remedies, 15 NUTRITION FORUM 1 (Jan/Feb. 1998); Terry Toy, Take Two Eyes of Newt and Call Me in the Morning, BUS. WK., Mar. 28, 1994, at 144; Dan McGraw, Flu Symptoms - Try Duck, U.S. NEWS & WORLD REP. Feb. 17, 1997, at 51; Martin Kaufman, Homeopathy in America, LANCET 120-23 (Oct. 18, 1986).
190. Homeopathy: Much Ado About Nothing, supra note 38, at 201; Steven Barrett, The Unethical Behavior of Pharmacists: How to Market Dubious Supplements & Unproven Remedies, 15 NUTRITION FORUM 1 (Jan/Feb. 1998); Terry Toy, Take Two Eyes of Newt and Call Me in the Morning, BUS. WK., Mar. 28, 1994, at 144; Dan McGraw, Flu Symptoms - Try Duck, U.S. NEWS & WORLD REP. Feb. 17, 1997, at 51; Martin Kaufman, Homeopathy in America, LANCET 120-23 (Oct. 18, 1986).
191. Homeopathy: Much Ado About Nothing, supra note 38, at 201; Steven Barrett, The Unethical Behavior of Pharmacists: How to Market Dubious Supplements & Unproven Remedies, 15 NUTRITION FORUM 1 (Jan/Feb. 1998); Terry Toy, Take Two Eyes of Newt and Call Me in the Morning, BUS. WK., Mar. 28, 1994, at 144; Dan McGraw, Flu Symptoms - Try Duck, U.S. NEWS & WORLD REP. Feb. 17, 1997, at 51; Martin Kaufman, Homeopathy in America, LANCET 120-23 (Oct. 18, 1986).
192. Homeopathy: Much Ado About Nothing, supra note 38, at 201; Steven Barrett, The Unethical Behavior of Pharmacists: How to Market Dubious Supplements & Unproven Remedies, 15 NUTRITION FORUM 1 (Jan/Feb. 1998); Terry Toy, Take Two Eyes of Newt and Call Me in the Morning, BUS. WK., Mar. 28, 1994, at 144; Dan McGraw, Flu Symptoms - Try Duck, U.S. NEWS & WORLD REP. Feb. 17, 1997, at 51; Martin Kaufman, Homeopathy in America, LANCET 120-23 (Oct. 18, 1986).
193. Pharmacists Survey, 15 J. CLINICAL PHARMACY & THERAPEUTICS 131-39 (1990).
194. Alternative Medicine: Expanding Medical Horizons: A Report to the National Institutes of Health on Alternative Medical Systems and Practices in the United States, prepared under the auspices of the Workshop on Alternative Medicine, Chantilly, VA at 83-85 (Sept. 14-16, 1992). In contrast, an outspoken critic of some alternative therapies, recently acknowledged that while they could be beneficial, "entrusting your health to certain alternative providers would be like taking atrip on a plane piloted by a pilot who uses alternative navigation, based on astrology an a flat-Earth map." John H. Renner (on file in the Homeopathy Files, 1997, FDA History Office).
195. The NIH's Office of Alternative Medicine has been criticized internally by NIH's scientists, and also by outsiders. See James Harvey Young, The Development of the Office of Alternative Medicine in the National Institutes of Health, 1991-1996, 72 BULL. HIST. MED. 279-98 (1998).
196. Leon Jaroff, What Will Happen to Alternative Medicine, TIME, Nov. 8, 1999, at 77.
197. Pub. L. No. 103-417, 108 Stat. 4325 (codified at 21 U.S.C. § 301 note (1994)).
198. "This statement has not been evaluated by the FDA. This product is not intended to diagnose, treat, cure, or prevent any disease." For one critique of the agency's policies on dietary supplements, see James Harvey Young, Health Fraud: A Hardy Perennial, 9 J. POL'Y HIST. 117-40 (1997).
199. Before the Comm. on Gov't Reform, 106th Cong., 1st Sess. 3 (Mar. 25, 1999) (statement of Dr. Henney, Commissioner of Food & Drugs, FDA).
200. Jaroff, supra note 176, at 77.
201. Id.
202. Id.
203. Pinco & Rubin, supra note 171, at 143.
204. Homeopathic Indications Based on Conventional Efficiency Criteria Urged, F-D-C REP. ("The Tan Sheet"), 15 (Mar. 20, 1995); Homeopathy is Vulnerable, 20 NAT'L COUNCIL AGAINST HEALTH FRAUD NEWSL. 1 (1997).
205. Homeopathic Indications Based on Conventional Efficiency Criteria Urged, F-D-C REP. ("The Tan Sheet"), 15 (Mar. 20, 1995); Homeopathy is Vulnerable, 20 NAT'L COUNCIL AGAINST HEALTH FRAUD NEWSL. 1 (1997).