Hostname: page-component-7479d7b7d-68ccn Total loading time: 0 Render date: 2024-07-08T06:14:17.923Z Has data issue: false hasContentIssue false

Pharmaceutical patenting and the transformation of American medical ethics

Published online by Cambridge University Press:  24 November 2016

JOSEPH M. GABRIEL*
Affiliation:
Department of Behavioral Sciences and Social Medicine, College of Medicine, Florida State University, 1115 West Call Street, Tallahassee, FL 32306-4300, USA. Email: joseph.gabriel@med.fsu.edu.

Abstract

The attitudes of physicians and drug manufacturers in the US toward patenting pharmaceuticals changed dramatically from the mid-nineteenth century to the mid-twentieth. Formerly, physicians and reputable manufacturers argued that pharmaceutical patents prioritized profit over the advancement of medical science. Reputable manufactures refused to patent their goods and most physicians shunned patented products. However, moving into the early twentieth century, physicians and drug manufacturers grew increasingly comfortable with the idea of pharmaceutical patents. In 1912, for example, the American Medical Association dropped the prohibition on physicians holding medical patents. Shifts in wider patenting cultures therefore transformed the ethical sensibilities of physicians.

Type
Research Article
Copyright
Copyright © British Society for the History of Science 2016 

Access options

Get access to the full version of this content by using one of the access options below. (Log in options will check for institutional or personal access. Content may require purchase if you do not have access.)

References

1 Fishbein, Morris, ‘Medical patents’, Journal of the American Medical Association (1937), 109, pp. 15391543 CrossRefGoogle Scholar.

2 Jonsen, Albert R., The Birth of Bioethics, New York: Oxford University Press, 1998 CrossRefGoogle Scholar.

3 ‘Physiology of circulation’, Medico-chirurgical Review, and Journal of Medical Science, 1 June 1823, p. 38, quoted in Gabriel, Joseph M., Medical Monopoly: Intellectual Property Rights and the Origins of the Modern Pharmaceutical Industry, Chicago: The University of Chicago Press, 2014, p. 25 CrossRefGoogle Scholar. The first section of this paper is partially a summary of some of the arguments I made in Medical Monopoly; I have included this material for those readers who are unaware of my earlier work and because it is essential to the development of the argument later in the paper. On the relationship between medical science and physician character in the nineteenth-century United States see also Baker, Robert, Before Bioethics: A History of American Medical Ethics from the Colonial Period to the Bioethics Revolution, New York: Oxford University Press, 2013 CrossRefGoogle Scholar; Browner, Stephanie B., Profound Science and Elegant Literature: Imagining Doctors in Nineteenth-Century America, Philadelphia: University of Pennsylvania Press, 2005, pp. 1538 CrossRefGoogle Scholar; Warner, John Harley, The Therapeutic Perspective: Medical Practice, Knowledge, and Identity in America, 1820–1885, Princeton, NJ: Princeton University Press, 1997 CrossRefGoogle Scholar.

4 Anon., , ‘Patents in medicine and surgery,’ Medical and Surgical Reporter (1867) 17, pp. 190191 Google Scholar, quoted in Gabriel, Joseph M., ‘A thing patented is a thing divulged: Francis E. Stewart, George S. Davis, and the legitimization of intellectual property rights in pharmaceutical manufacturing, 1879–1911’, Journal of the History of Medicine and Allied Sciences (2009), 64, pp. 135172, 144CrossRefGoogle Scholar.

5 Quoted in Baker, op. cit. (3), p. 94.

6 ‘Code of Medical Ethics’, Proceedings of the National Medical Conventions (1847), pp. 91–106. On the 1847 code and its implications see Baker, op. cit. (3); Baker, Robert B., Caplan, Arthur L., Emanuel, Linda L. and Latham, Stephen R. (eds.), The American Medical Ethics Revolution: How the AMA's Code of Ethics Has Transformed Physicians’ Relationships to Patients, Professionals, and Society, Baltimore: Johns Hopkins University Press, 1999 CrossRefGoogle Scholar; Baker, Robert (ed.), The Codification of Medical Morality, vol. 2: Anglo-American Medical Ethics and Medical Jurisprudence in the Nineteenth Century (Boston: Kluwer Academic Publishers, 1993)CrossRefGoogle Scholar; Haller, John S. Jr, American Medicine in Transition, 1840–1910 (Champaign: University of Illinois Press, 1981), pp. 234279 Google Scholar.

7 For example, Proceedings of the State Medical Convention of the Medical Society of the State of North Carolina (1849), pp. 9, 12. Baker, op. cit. (3), pp. 182–183, briefly discusses tensions between the Ohio and Massachusetts medical societies and the AMA over patenting; see also Haller, op. cit. (6), pp. 240–242.

8 Hooker, Worthington, Physician and Patient; or, a Practical View of the Mutual Duties, Relations and Interests of the Medical Profession and the Community, New York: Baker and Scribner, 1849, p. 89 Google Scholar.

9 ‘Nostrum venders’, Chicago Medical Journal (February 1859), p. 127; ‘Progress of medical science’, Medical Times and Gazette, 13 March 1852, p. 270. On so-called patent medicines, the standard work is still Young, James Harvey, The Toadstool Millionaires: A Social History of Patent Medicines in America before Federal Regulation, Princeton, NJ: Princeton University Press, 1961 Google Scholar.

10 Gabriel, op. cit. (3), pp. 63–69. See also United States patent number 231,236 (1880). On Albert B. Lyons see Liebenau, Jonathan, Medical Science and Medical Industry: The Formation of the American Pharmaceutical Industry, Baltimore: The Johns Hopkins University Press, 1987, pp. 4344 CrossRefGoogle Scholar.

11 On the commercialization of drug plants from California by Parke-Davis see Gabriel, op. cit. (3), pp. 89–91. For an account of another botanical expedition supported by the company see Bender, George A., ‘Rough and ready research – 1887 style’, Journal of the History of Medicine and Allied Sciences (1968), 23, pp. 159166 CrossRefGoogle ScholarPubMed.

12 Gabriel, op. cit. (3), pp. 78–98, 114–123, 139–145. On the introduction of the German synthetic drugs see also McTavish, Jan R., Pain & Profits: The History of the Headache and Its Remedies in America, New Brunswick, NJ: Rutgers University Press, 2004 Google Scholar.

13 Anon., , ‘Editorial. patents and trade-marks,’ Medical and Surgical Reporter (1896) 75, p. 341 Google Scholar, quoted in Gabriel, op. cit. (3), p. 170. As I argue in Medical Monopoly, Francis E. Stewart, who was both a physician and pharmacist and worked closely with Parke-Davis during the 1880s, was one of the most important reformers leading this effort. See Gabriel, op. cit. (3), pp. 133–139, 164–171, 188–194. On the broader rejection of orthodox medical ethics among physicians, of which the embrace of patenting was one part, see also Baker, op. cit. (3); John Harley Warner, ‘The 1880s rebellion against the AMA Code of Ethics: “scientific democracy” and the dissolution of orthodoxy’, in Baker et al., op. cit. (6), pp. 52–69.

14 Lane, L.C., ‘Address of welcome to the American Medical Association’, Journal of the American Medical Association, 23 June 1894, p. 956 Google Scholar.

15 Simonton, A.C., ‘Code of revision’, Journal of the American Medical Association, 5 May 1894, pp. 678679 CrossRefGoogle Scholar. For a rejoinder see Davis, Nathan S., ‘Proposed revision of the Code of Ethics of the American Medical Association’, Journal of the American Medical Association, 14 April 1894, p. 557 Google Scholar.

16 Conner, Lewis A., writing in ‘Report of the Committee on the Pharmacopeia’, Transactions of the Section on Practice of Medicine of the American Medical Association at the Sixteenth Annual Session (1909), p. 325 Google Scholar. On the adrenalin patent dispute between Parke-Davis and H.K. Mulford & Company see Gabriel, op. cit. (3), pp. 230–237; Harkness, Jon, ‘Dicta on Adrenalin(e): myriad problems with Learned Hand's product-of-nature pronouncements in Parke-Davis v. Mulford ’, Journal of the Patent and Trademark Office Society (2011) 93, pp. 363399 Google Scholar; Beauchamp, Christopher, ‘Patenting nature: a problem of history,’ Stanford Technology Law Review (2013) 16, pp. 257311 Google Scholar.

17 ‘Principles of medical ethics’, Journal of the Indiana State Medical Association, 15 September 1912, pp. 406–410, 407.

18 ‘Report of the Judicial Council’, Journal of the American Medical Association, 4 July 1914, p. 106.

19 Proceedings of the American Pharmaceutical Association at the Forty-Fifth Meeting, Baltimore: American Pharmaceutical Association, 1897, p. 10 Google Scholar.

20 Steen, Kathryn, The American Synthetic Organic Chemicals Industry War and Politics, 1910–1930, Chapel Hill: University of North Carolina Press, 2014, pp. 149156 CrossRefGoogle Scholar.

21 Pernick, Martin S. quoted in Halpern, Sydney A., Lesser Harms: The Morality of Risk in Medical Research, Chicago: The University of Chicago Press, 2004, p. 3 Google Scholar. On human experimentation in the nineteenth-century United States see also Green, Alexa, ‘Working ethics: William Beaumont, Alexis St. Martin, and medical research in antebellum America’, Bulletin of the History of Medicine (2010) 84(2), pp. 193216 CrossRefGoogle Scholar; Lederer, Susan E., Subjected to Science: Human Experimentation in America before World War II, Baltimore: Johns Hopkins University Press, 1994, pp. 172 Google Scholar.

22 ‘Anti-vivisectionists make hopeless fight’, Philadelphia Inquirer, 18 May 1911, p. 6.

23 Notable legal cases in this regard include Mohr v. Williams 95 Minn. 261 (1905); Luka v. Lowrie 171 Mich. 122 (1912); Schloendorff v. Society of New York Hospital 133 NYS 1143 (1914); Barfield v. S. Highland Infirmary 191 Ala. 553 (1915). As far as I know, a detailed history of the origins of this legal concept in the United States has not yet been written, but for a general history see Faden, Ruth R. and Beauchamp, Tom L., A History and Theory of Informed Consent, New York: Oxford University Press, 1986 Google Scholar.

24 See Lederer, Susan E., ‘“The right and wrong of making experiments on human beings”: Udo J. Wile and syphilis, 1917’, Bulletin of the History of Medicine (1984) 58, pp. 380397 Google Scholar.

25 The right and wrong of making experiments on human beings’, Journal of the American Medical Association (1916) 19, pp. 13721373 Google Scholar.

26 ‘Historical financial data’ (1958), Parke, Davis Research Laboratory Records, 1902–1950, Archives Center, National Museum of American History (hereafter PDR), b.5, f. BDd 1958.

27 Patents assigned to the firm following the war included US patent numbers 1,271,111 (1918), 1,286,944 (1918), 1,443,552 (1923), 1451357 (1923), 1,624,546 (1927), 1,615,870 (1927), 1,663,205 (1928), 1664123 (1928), 1,665,781 (1928), 1,717,198 (1929).

28 Swann, John, Academic Scientists and the Pharmaceutical Industry: Cooperative Research in Twentieth-Century America, Baltimore: Johns Hopkins University Press, 1988 Google Scholar; Furman, Jeffrey L. and MacGarvie, Megan J., ‘Academic science and the birth of industrial research laboratories in the U.S. pharmaceutical industry’, Journal of Economic Behavior & Organization (2007) 63(4), pp. 756776 CrossRefGoogle Scholar; Rasmussen, Nicolas, ‘The drug industry and clinical research in interwar America: three types of physician collaborator’, Bulletin of the History of Medicine (2005) 79, pp. 5080 CrossRefGoogle ScholarPubMed; Oudshorn, Nelly, ‘United we stand: the pharmaceutical industry, laboratory and clinic in the development of sex hormones into scientific drugs, 1920–1940’, Science, Technology and Human Values (1993) 18, pp. 524 CrossRefGoogle Scholar; Parascandola, John, The Development of American Pharmacology: John J. Abel and the Shaping of a Discipline, Baltimore: Johns Hopkins University Press, 1992, pp. 91125 Google Scholar; Liebenau, op. cit. (10).

29 Myriam Mertens, ‘Chemical compounds in the Congo: pharmaceuticals and the ‘crossed history’ of public health in Belgian Congo (ca. 1905–1939)’, unpublished PhD dissertation, Ghent University, 2014; Cassier, Maurice and Sinding, Christiane, ‘“Patenting in the public interest”: administration of insulin patents by the University of Toronto’, History and Technology (2008) 24, pp. 153171 CrossRefGoogle Scholar; Apple, Rima, ‘Patenting university research: Harry Steenbock and the Wisconsin Alumni Research Foundation’, Isis (1989) 80, pp. 375394 CrossRefGoogle ScholarPubMed; Weiner, Charles, ‘Patenting and academic research: historical case studies’, Science, Technology, and Human Values (1987) 12, pp. 5062 CrossRefGoogle Scholar. On university patenting and academic–industrial cooperation more generally see Etzkowitz, Henry, MIT and the Rise of Entrepreneurial Science, New York: Routledge, 2002 CrossRefGoogle Scholar; Mowery, David C., Nelson, Richard R., Sampat, Bhaven N. and Ziedonis, Arvids A., Ivory Tower and Industrial Innovation: University–Industry Technology Transfer before and after the Bayh-Dole Act, Stanford, CA: Stanford University Press, 2004 Google Scholar.

30 Quoted in Cassier and Sinding, op. cit. (29), p. 154 n. 11.

31 Unclear to E.M. Houghton, 10 November 1927, PDR, b. 25, f. KJc 1922–1929.

32 The phrase ‘entrepreneurial science’ is taken from Etzkowitz, op. cit. (29).

33 Greg, Alan, ‘University Patents’, Science (10 March 1933), p. 259 Google Scholar.

34 For example, when pharmacologist Arthur L. Tatum at the University of Wisconsin began working on barbiturates with Abbott, he suggested that ‘any ideas that we have as to means of study, which are new – in other words, original ideas applicable to the problem – we feel as though should be kept confidential, at least until we say so’. Arthur Tatum to J.F. Biehn, 21 October 1929, Arthur Tatum Papers, University of Wisconsin Archives, b. 1, f. 1. On Tatum see Swann, op. cit. (28).

35 Morris Fishbein, ‘Medical patents’, op. cit. (1), p. 1542; Morris Fishbein to Claude E. Forkner, 28 December 1937, Morris Fishbein Papers, University of Chicago (hereafter MFP), b. 92, f. 12; ‘Copper–iron patent’, 20 April 1933, MFP, b. 92, f. 13. See also ‘Problem of medical patents’, Journal of the American Medical Association, 22 July 1933, pp. 284–285; and correspondence in MFP, esp. b. 13.

36 Report of the Conference on Medical Patents under the Auspices of the Board of Trustees, American Medical Association, Chicago: American Medical Association, 1939 Google Scholar.

37 Torald Sollman in Report of the Conference on Medical Patents, op. cit. (36), pp. 49–50.

38 Morris Fishbein in Report of the Conference on Medical Patents, op. cit. (36), p. 45.

39 Fishbein, Morris, ‘The insulin monopoly’, Journal of the American Medical Association (1941), p. 112 Google Scholar.

40 Palmer, Archie M., Survey of University Patent Policies, Preliminary Report, Washington, DC: National Research Council, 1948, pp. 55, 10Google Scholar. The literature on the post-war American pharmaceutical industry is extensive. Works I have drawn on for my understanding of this period include Podolsky, Scott H., The Antibiotic Era: Reform, Resistance, and the Pursuit of Rational Therapeutics, Baltimore: Johns Hopkins University Press, 2014 Google Scholar; Greene, Jeremy A., Generic: The Unbranding of Modern Medicine, Baltimore: Johns Hopkins University Press, 2014 Google Scholar; Tobbell, Dominique, Pills, Power, and Policy: The Struggle for Drug Reform in Cold War America and Its Consequences, Berkeley: University of California Press, 2011 Google Scholar; Greene, Jeremy A., Prescribing by Numbers: Drugs and the Definition of Disease, Baltimore: Johns Hopkins University Press, 2006 Google Scholar; Healy, David, The Antidepressant Era, Cambridge, MA: Harvard University Press, 1999 Google Scholar; Galambos, Louis and Sewell, Jane Eliot, Networks of Innovation: Vaccine Development at Merck, Sharp & Dohme, and Mulford, 1895–1995, New York: Cambridge University Press, 1995 Google Scholar.

41 Report of the Council on constitution and bylaws’, Journal of the American Medical Association (1955) 157, p. 945 Google Scholar.

42 Principles of Medical Ethics – 1957’, Journal of the American Medical Association (27 July 1957) 164, p. 1482 CrossRefGoogle Scholar.

43 Tobbell, op. cit. (40), pp. 71–75.

44 Federal Trade Commission, Economic Report on Antibiotics Manufacture, Washington, DC: United States Government Printing Office, 1958, pp. 225257 Google Scholar.

45 On Kefauver's investigation into the drug industry and the resulting amendments to the 1938 Food, Drug, and Cosmetic Act see Greene, Jeremy A. and Podolsky, Scott H., ‘Reform, regulation, and pharmaceuticals: the Kefauverr-Harris Amendments at 50’, New England Journal of Medicine (2012) 367, pp. 14811483 CrossRefGoogle ScholarPubMed; Tobbell, op. cit. (40); Carpenter, Daniel, Reputation and Power: Organizational Image and Pharmaceutical Regulation at the FDA, Princeton, NJ: Princeton University Press, 2010 Google Scholar; Hilts, Philip J., Protecting America's Health: The FDA, Business, and One Hundred Years of Regulation, Chapel Hill: University of North Carolina Press, 2004 Google Scholar; Richard Edward McFayden, ‘Estes Kefauver and the drug industry’, doctoral dissertation, Emory University, 1973.

46 Quoted in Steven Pray, W., A History of Nonprescription Product Regulation, New York: Pharmaceutical Products Press, 2003, p. 153 Google Scholar.

47 Quoted in Tobbell, op. cit. (40), p. 102.

48 Quoted in Washington news’, Journal of the American Medical Association (1965) 192, p. 15 CrossRefGoogle Scholar.

49 United States Advisory Committee on Human Radiation Experiments, The Final Report of the Advisory Committee on Human Radiation Experiments, New York: Oxford University Press, pp. 7578 Google Scholar.

50 Quoted in United States Advisory Committee on Human Radiation Experiments, op. cit. (49), p. 77.

51 Baker, op. cit. (3), p. 271.

52 For example, Guttentag, Otto E., ‘The problem of experimentation on human beings: the physician's point of view’, Science (1953) 117, pp. 207210 CrossRefGoogle ScholarPubMed.

53 Mashour, George A., ‘Altered states: LSD and the anesthesia laboratory of Henry Knowles Beecher’, CSA Bulletin (Winter 2009), pp. 6874 Google Scholar; McCoy, Alfred W., ‘Science in Dachau's shadow: Hebb, Beecher, and the Development of CIA psychological torture and modern medical ethics’, Journal of the History of the Behavioral Sciences (2007) 43, pp. 401417 CrossRefGoogle ScholarPubMed.

54 Beecher, Henry K., ‘Experimentation in man’, Journal of the American Medical Association (1959) 169, pp. 461473 CrossRefGoogle ScholarPubMed.

55 130.37 consent for use of investigational new drugs on humans: statement of policy’, in Code of Federal Regulations of the United States of America Title 21 Parts 130 to 146e Revised as of January 1, 1967, Washington, DC: United States Government Printing Office, 1967, pp. 3233 Google Scholar.

56 Rothman, David J., Strangers at the Bedside: A History of How Law and Bioethics Transformed Medical Decision Making, New York: Basic Books, 1991, p. 94 Google Scholar.

57 Morris Fishbein, ‘The new drug laws,’ MFP, b. 95, f. 14.

58 Beecher, H.K., ‘Ethics and clinical research’, New England Journal of Medicine (1966) 274, pp. 13541360 CrossRefGoogle ScholarPubMed; quote from Henry K. Beecher to Robert Kennedy, 23 September 1965, Henry K. Beecher Papers, Harvard University, b. 11, f. 37. On Beecher and his so-called ‘bombshell’ see Stark, Laura, ‘The unintended ethics of Henry K Beecher’, The Lancet (2016) 387, pp. 23742375 CrossRefGoogle Scholar; Freidenfelds, Lara, ‘Recruiting allies for reform: Henry Knowles Beecher's “Ethics and Clinical Research”’, International Anesthesiology Clinics (2007), pp. 79103 CrossRefGoogle Scholar; Katz, Jay, ‘“Ethics and Clinical Research” revisited: a tribute to Henry K. Beecher’, Hastings Center Report (1993) 22, pp. 3139 CrossRefGoogle Scholar; Rothman, op. cit. (56), pp. 70–84.

59 On the history of generic drugs in the United States, including the debate about therapeutic equivalence, see Greene, Generic, op. cit. (40); Tobbell, op. cit. (40); Carpenter, Daniel and Tobbell, Dominique, ‘Bioequivalence: the regulatory career of a pharmaceutical concept’, Bulletin of the History of Medicine (2011) 85, pp. 93131 CrossRefGoogle ScholarPubMed. On the nineteenth-century origins of generic names see Gabriel, op. cit. (3).

60 For example, Rothman, op. cit. (56); Howell, Joel D., ‘A history of the American Society for Clinical Investigation’, Journal of Clinical Investigation (2009) 119, pp. 682697 CrossRefGoogle ScholarPubMed.

61 Rose, Nikolas, The Politics of Life Itself: Biomedicine, Power, and Subjectivity in the Twenty-First Century, Princeton, NJ: Princeton University Press, 2007 CrossRefGoogle Scholar. The literature on the ethics of gene patents and related issues is large, but for a useful introduction see Resnik, David B., Owning the Genome: A Moral Analysis of DNA Patenting, Albany: State University of New York Press, 2004 CrossRefGoogle Scholar.

62 For example, Mitnovetski, O. and Nicol, D., ‘Are patents for methods of medical treatment contrary to the ordre public and morality or “generally inconvenient”?Journal of Medical Ethics (2004) 30, pp. 470475 CrossRefGoogle Scholar; Garris, Joel J., ‘The case for patenting medical procedures’, American Journal of Law and Medicine (1996) 85, pp. 85108 CrossRefGoogle Scholar.

63 For example, Kantarjian, Hagop and Rajkumar, S. Vincent, ‘Why are cancer drugs so expensive in the United States, and what are the solutions?’, Mayo Clinic Proceedings (2015) 90, pp. 500504 CrossRefGoogle ScholarPubMed; Doctors Without Borders, ‘The cost of medicine: a special report’, Alert (2015) 16(3), pp. 115 Google Scholar; Shah, Aakas Kaushik, Warsh, Jonathan and Kesselheim, Aaron S., ‘The ethics of intellectual property rights in an era of globalization’, Journal of Law, Medicine & Ethics (2013) 41, pp. 841851 CrossRefGoogle Scholar.

64 Hayden, Corrine P., ‘A generic solution? Pharmaceuticals and the politics of the similar in Mexico’, Current Anthropology (2007) 48, pp. 475495 CrossRefGoogle Scholar; see also Cori Hayden, ‘Distinctively similar: a generic problem’, U.C. Davis Law Review (2013) 47, pp. 601632 Google Scholar.

65 For example, Gagne, Joshua J. and Choudhry, Niteesh K., ‘How many “me-too” drugs is too many?’, Journal of the American Medical Association (2011) 305, pp. 711712 CrossRefGoogle ScholarPubMed; Banerjee, Amitava, Hollis, Aidan and Pogge, Thomas, ‘The Health Impact Fund: incentives for improving access to medicines’, The Lancet (2010) 375, pp. 166169 CrossRefGoogle ScholarPubMed; Richard Gold, E., Kaplan, Warren, Orbinski, James, Harland-Logan, Sarah and N-Marandi, Sevil, ‘Are patents impeding medical care and innovation?’, PLoS Medicine (2009) 7, pp. 15 Google Scholar, available at http://dx.doi.org/10.1371/journal.pmed.1000208, accessed 29 June 2016; Applbaum, Kalman, ‘Is marketing the enemy of pharmaceutical innovation?’, Hastings Center Report (2009) 39, pp. 1317 CrossRefGoogle ScholarPubMed; Nathan, Carl, ‘Aligning pharmaceutical innovation with medical need’, Nature Medicine (2007) 13, pp. 304308, 304CrossRefGoogle ScholarPubMed.