The testing of sanocrysin: Science, profit, and innovation in clinical trial design, 1926-31

Journal of the History of Medicine and Allied Sciences

Volumn 69, Issue 4, 2014, Pages 604-632

  Gabriel, Joseph M ^a  

^a FLORIDA STATE UNIVERSITY COLLEGE OF MEDICINE   (United States)

Author keywords

Clinical trials; Davis Co.; Parke; Pharmaceuticals; Sanocrysin; Therapeutic reform; Tuberculosis

Indexed keywords

DRUG; GOLD DERIVATIVE;

CLINICAL TRIAL (TOPIC); HISTORY; HUMAN; TUBERCULOSIS; UNITED STATES;

CLINICAL TRIALS AS TOPIC; GOLD COMPOUNDS; HISTORY, 20TH CENTURY; HUMANS; PHARMACEUTICAL PREPARATIONS; TUBERCULOSIS; UNITED STATES;

EID: 84942319248     PISSN: 00225045     EISSN: 14684373     Source Type: Journal    
DOI: 10.1093/jhmas/jrt040     Document Type: Review

References (68)

1. James Burns Amberson, B. T. McMahon, and Max Pinner, "A Clinical Trial of Sanocrysin in Pulmonary Tuberculosis," Am. Rev. Tuberculosis, 1931, 24, 401-35
2. Marcia L. Meldrum, "A Brief History of the Randomized Controlled Trial: From Oranges and Lemons to the Gold Standard," Hematol. Oncol. Clin. North Am., 2000, 14, 745-60
3. Ted J. Kaptchuk, "Intentional Ignorance: A History of Blind Assessment and Placebo Controls in Medicine," Bull. Hist. Med., 1998, 72, 389-433
4. Abraham M. Lilienfeld, "Ceteris Paribus: The Evolution of the Clinical Trial," Bull. Hist. Med., 1982, 56, 1-18.
5. On the history of placebos, see also Arthur K. Shapiro and Elaine Shapiro, The Powerful Placebo: From Ancient Priest to Modern Physician (Baltimore: Johns Hopkins University Press, 2010)
6. Suzanne White, "Medicine's Humble Humbug: Four Periods in the Understanding of the Placebo," Pharm. Hist., 1985, 27, 51-60
7. Arthur K. Shapiro, "A Contribution to a History of the Placebo Effect," Behav. Sci., 1960, 5, 109-35.
8. Harry M. Marks, The Progress of Experiment: Science and Therapeutic Reform in the United States, 1900-1990 (Baltimore: Johns Hopkins University Press, 1997), 39.
9. John Swann, Academic Scientists and the Pharmaceutical Industry: Cooperative Research in Twentieth Century America (Baltimore: Johns Hopkins University Press, 1988)
10. Nicolas Rasmussen, "The Drug Industry and Clinical Research in Interwar America: Three Types of Physician Collaborator," Bull. Hist. Med., 2005, 79, 50-80.
11. In addition to Marks, Progress of Experiment, other works which examine the relationship between the pharmaceutical industry and academic scientists during the interwar period include Nicolas Rasmussen, On Speed: The Many Lives of Amphetamine (New York: New York University Press, 2008), 1-52
12. John Parascandola, The Development of American Pharmacology: John J. Abel and the Shaping of a Discipline (Baltimore: Johns Hopkins University Press, 1992), 91-125
13. Jeffrey L. Furman and Megan J. MacGarvie, "Academic Science and the Birth of Industrial Research Laboratories in the U.S. Pharmaceutical Industry," J. Econ. Behav. Org., 2007, 63, 756-76.
14. On the development of Sanocrysin, see Thomas G. Benedek, "The History of Gold Therapy for Tuberculosis," J. Hist. Med. Allied Sci., 2004, 59, 50-89
15. Georgina D. Feldberg, Disease and Class: Tuberculosis and the Shaping of Modern North American Society (New Brunswick, New Jersey: Rutgers University Press, 1995), 142-44
16. R. Y. Keers, "The Gold Rush 1923-35," Thorax, 1980, 35, 884-89.
17. On the use of gold in medicine more generally, see Gregory J. Higby, "Gold in Medicine," Gold Bull., 1982, 15, 130-40.
18. For a general overview of the history of tuberculosis, see Thomas Dormandy, The White Death: A History of Tuberculosis (New York: New York University Press, 2000).
19. H. Møllgaard, "The Theoretical Basis of the Sanocrysin Treatment of Tuberculosis," BMJ, 1925, 4, 643-47.
20. For example, "Sanocrysin - A Gold Cure for Tuberculosis," Am. J. Pub. Health., 1925, 15, 144-45
21. "Discussion on the Treatment of Pulmonary Tuberculosis with Sanocrysin," Proc. R. Soc. Med., 1926, 19, 53-70
22. H. E. MacDermot, "The Present Position of Sanocrysin," Can. Med. Assoc. J., 1926, 16, 1375-76.
23. On the history of tuberculin treatment, see Cristina Vilaplana and Pere-Joan Cardona, "Tuberculin Immunotherapy: Its History and Lessons to Be Learned," Microbes Infect., 2009, 12, 1-7.
24. Francis E. Stewart, "The Relation of Pharmacists to Physicians and the Relation of Pharmacy to Materia Medica and Drug Therapeutics," Trans. Am. Ther. Soc., 1903, 3, 29-35.
25. Joseph M. Gabriel, "A Thing Patented Is a Thing Divulged: Francis E. Stewart, George Davis, and the Legitimization of Intellectual Property Rights in Pharmaceutical Manufacturing, 1879-1911," J. Hist. Med. Allied Sci., 2009, 64, 135-72.
26. Parke, Davis & Company, "Historical Financial Data," in Archives Center, National Museum of American History, Smithsonian Institution, Parke, Davis & Company Collection (hereafter abbreviated as PDC), b. 5, f. "Historical, financial data."
27. David E. Lilienfeld, "The First Pharmacoepidemiologic Investigations: National Drug Safety Policy in the United States, 1901-1902," Perspect. Bio. Med., 2008, 51, 188-98
28. Ramunas A. Kondratas, "Biologics Control Act of 1902," in The Early Years of Federal Food and Drug Control, ed. James Harvey Young (Madison, Wisconsin: American Institute of the History of Pharmacy, 1982), 8-27
29. Jonathan Liebenau, Medical Science and Medical Industry: The Formation of the American Pharmaceutical Industry (London: MacMillan Press, 1987), 89-90.
30. "Koch's Idea Used by Dr. Møllgaard," New York Times, November 16, 1924, 28
31. "New Danish Tuberculosis Treatment to Be Treated by Government," Daily Sci. News Bull., December 23, 1924, 1-2.
32. "U.S. Doctor May Have Cure for Tuberculosis," The Bee [Danville, Virginia], January 7, 1925, 6.
33. "Sanocrysin - The Møllgaard Tuberculosis Remedy," J. Am. Med. Assoc., 1925, 84, 287-88. An earlier draft of the editorial, with corrections marked, is found in NIHGR, b. 24, f. "Sanocrysin Literature References."
34. William Charles White to Ludvig Hektoen, February 3, 1926, NIHGR, b. 24, f. "Sanocrysin Literature References"; a typed copy of the article is in the same folder. See also "Sanocrysin, Again," J. Am. Med. Assoc., 1926, 86, 487
35. "Sanocrysin," J. Missouri State Med. Assoc., 1926, 23, 162
36. "Sanocrysin," Minnesota Med., 1926, 9, 208.
37. John Parascandola, "The 'Preposterous Provision': The American Society of Pharmacology and Experimental Therapeutics' Ban on Industrial Pharmacologists, 1908-1941," in Pill Peddlers: Essays on the History of the Pharmaceutical Industry, ed. Jonathan Liebenau, Gregory Higby, and Elaine Stroud (Madison, Wisconsin: American Institute of the History of Pharmacy, 1990), 29-47.
38. On Herty, see Cermaine M. Reed Crusading for Chemistry: The Professional Career of Charles Holmes Herty (Athens: University of Georgia Press, 2010)
39. John Parascandola, "Charles Holmes Herty and the Effort to Establish an Institute for Drug Research in Post World War I America," in Chemistry in Modern Society: Historical Essays in Honor of Aaron J. Ihde, ed. John Parascandola and James Whorton (Washington, DC: American Chemical Society, 1983), 85-103.
40. On the origins of the NIH, see Victoria Angela Harden, Inventing the NIH: Federal Biomedical Research Policy, 1887-1937 (Baltimore: Johns Hopkins University Press, 1986).
41. Attitudes toward the proposed institute can be seen in the proceedings of a conference held to discuss the proposal, printed in the January 1919 issue of Journal of Industrial and Engineering Chemistry. Speakers included Reid Hunt, Frank R. Eldred, and Arthur S. Loevenhart, all of whom strongly supported the institute and advocated closer cooperation between academic scientists and reputable manufacturers. For example, A. S. Loevenhart, "An Institute for Research in Synthetic Organic Chemistry," J. Ind. Eng. Chem., 1918, 10, 972-73.
42. The outlines of Herty's early plan can be found in The Future Independence and Progress of American Medicine in the Age of Chemistry (New York: Chemical Foundation Inc., 1921).
43. As the Journal of the American Medical Association put it in 1925, "the first copies of a book by Møllgaard and his co-workers describing experiments with sodium auric thiosulphate, for which the name 'Sanocrysin' has been registered, have just been received in the United States⋯ the outstanding fact in connection with Sanocrysin is that it is only the name that is new." "Sanocrysin - The Møllgaard Tuberculosis Remedy," J. Am. Med. Assoc., 1925, 84, 287-88.
44. Kaptchuk, "Intentional Ignorance," 393-403.
45. John M. Eyler, "De Kruif 's Boast: Vaccine Trials and the Construction of a Virus," Bull. Hist. Med., 2006, 80, 409-38.
46. Kaptchuk, "Intentional Ignorance," 422-24.
47. Francis Marion Pottenger, Clinical Tuberculosis Volume II (St. Louis: Mosby Company, 1922), 396.
48. Other examples include Edgar Mayer, Clinical Application of Sunlight and Artificial Radiation, Including Their Physiological and Experimental Aspects with Special Reference to Tuberculosis (Baltimore: Williams & Wilkins Company, 1926), esp. 137-39
49. David C. Muthu, Pulmonary Tuberculosis: Its Etiology and Treatment (New York: William Wood & Co., 1922), 136-39
50. Sherman G. Bonney, Pulmonary Tuberculosis and Its Complications (Philadelphia: W.B. Saunders, 1910), 190-94
51. Arnold C. Klebs, Tuberculosis: ATreatise by American Authors (New York: D. Appleton, 1909), esp. 663-66.
52. John H. Lowman, The Conflict with Tuberculosis (Cleveland: Cleveland Medical Journal, 1902), 7.
53. Maurice Fishberg, Pulmonary Tuberculosis (Philadelphia: Lea & Febiger, 1922), 747, 768, 845.
54. J. Claxton Gittings and Frank Crozer Knowles, Tuberculosis in Infancy and Childhood (Philadelphia: J.B. Lippincott Company, 1922), 266.
55. George H. Weaver, Lawrason Brown, Robert B. Preble, et al, eds., The Practical Medicine Series. General Medicine (Chicago: Year Book Publishers, 1929), 286.
56. James Burns Amberson, B. T. McMahon, and Max Pinner, "A Clinical Trial of Sanocrysin in Pulmonary Tuberculosis," Am. Rev. Tuberc., 1931, 24, 401-35.
57. For an example of supportive examination of the drug from two British physicians, see G. E. Beaumont and E. C. Dodds, Recent Advances in Medicine: Clinical, Laboratory, Therapeutic (Philadelphia: P. Blakiston's Son & Co., 1934), 331.
58. Examples include H. S. Diehl, A. B. Baker, and D. W. Cowan, "Cold Vaccines: An Evaluation Based on a Controlled Study," J. Am. Med. Assoc., 1938, 111, 1168-73
59. Harry Gold, N. T. Kwit, and H. Otto, "The Xanthines (Theobromine and Aminophyllin) in the Treatment of Cardiac Pain," J. Am. Med. Assoc., 1937, 108, 2173-79
60. J. G. Corrigan and M. B. Strauss, "The Prevention of Hypochromic Anemia in Pregnancy," J. Am. Med. Assoc., 1936, 106, 1088-90
61. Ella M. Hediger and Hary Gold, "U.S.P. Ether from Large Drums and Ether from Small Cans Labeled 'For Anesthesia'," J. Am. Med. Assoc., 1935, 2244-2448
62. H. S. Diehl, "Medicinal Treatment of the Common Cold," J. Am. Med. Assoc., 1933, 101, 2042-49.
63. Some researchers also used placebo shams in a haphazard way. For example, D. L. Wilbur, A. R. MacLean, and E. V. Allen, "Clinical Observations on the Effect of Benzedrine Sulphate," J. Am. Med. Assoc., 1937, 109, 549-54.
64. Harry Marks, "Trust and Mistrust in the Marketplace: Statistics and Clinical Research, 1945-1960," Hist. Sci., 2000, 38, 343-55
65. Scott H. Podolsky, "Antibiotics and the Social History of the Controlled Clinical Trial, 1950-1970," J. Hist. Med. Allied Sci., 2010, 65, 327-67
66. Scott H. Podolsky and Jeremy A. Greene, "Combination Drugs - Hype, Harm, and Hope," N. Engl. J. Med., 2011, 365, 488-91, 47-50
67. George Weisz, "From Clinical Counting to Evidence-Based Medicine," in Body Counts: Medical Quantification in Historical and Sociological Perspective, ed. Gérard Jorland, Annick Opinel, and George Weisz (Montreal: McGill-Queen's University Press, 2005), 377-93.
68. On "pharmaceuticalization," see Susan Bell and A. E. Figert, "Medicalization and Pharmaceuticalization at the Intersections: Looking Backward, Sideways and Forward," Soc. Sci. Med., 2012, 75, 775-83.