Stem cell research and economic promises

Journal of Law, Medicine and Ethics

Volumn 38, Issue 2, 2010, Pages 303-313

  Caulfield, Timothy ^a  

^a UNIVERSITY OF ALBERTA   (Canada)

Author keywords

[No Author keywords available]

Indexed keywords

ARTICLE; ATTITUDE TO HEALTH; BIOMEDICAL TECHNOLOGY ASSESSMENT; COMMODIFICATION; CONFLICT; ECONOMIC DEVELOPMENT; ECONOMICS; EMBRYO RESEARCH; ETHICS; FINANCIAL MANAGEMENT; HEALTH CARE POLICY; HUMAN; INFORMATION DISSEMINATION; MANAGEMENT; MASS MEDIUM; PATENT; POLITICS; PUBLIC OPINION; TRUST; UNITED STATES;

ATTITUDE TO HEALTH; COMMODIFICATION; DISSENT AND DISPUTES; ECONOMIC DEVELOPMENT; EMBRYO RESEARCH; HEALTH POLICY; HUMANS; INFORMATION DISSEMINATION; MASS MEDIA; PATENTS AS TOPIC; POLICY MAKING; POLITICS; PUBLIC OPINION; RESEARCH SUPPORT AS TOPIC; TECHNOLOGY ASSESSMENT, BIOMEDICAL; TRUST; UNITED STATES;

EID: 77954946323     PISSN: 10731105     EISSN: 1748720X     Source Type: Journal    
DOI: 10.1111/j.1748-720X.2010.00490.x     Document Type: Conference Paper

References (68)

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14. For a critique of the Stem Cell Network's commercialization strategy, see Herder, note 1.
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18. As noted, the ethos occurs in other realms of research, an issue I have noted elsewhere (see, for example, T. Caulfield, " Sustainability and the Balancing of the Health Care and Innovation Agendas: The Commercialization of Genetic Research," 66 [2003]: 629-645. See also J. Downie and M. Herder, " Reflections on the Commercialization of Research Conducted in Public Institutions in Canada," 1, no. 1 [2007]: 23-44).
19. Interestingly, both the Michigan and Texas reports (the two most recent) characterize the situation as a " race." The Michigan report notes: " But, in the race to find cures using embryonic stem cell research, Michigan is at a serious disadvantage." See Goodman and Berger, note 7, at 5. The Texas analysis states, " Nonetheless, in the race among the states to find cures using embryonic stem cell research, Texas is currently a minor player and is at a serious disadvantage." See Weinstein et al., note 4, at iii.
20. Salter B, Harvey O. " Stem Cell Innovation in the USA: The Benefits of the Minimal State," Regenerative Medicine 2008, 3(no. 4):597-610. See, at abstract
21. For example, the enabling legislation that created the Canadian Institutes of Health Research, Canada's primary biomedical research funding entity, states that " commercialization of health research" and " economic development through health research" to be central goals of the agency. See, , RS. C. 2000, c.6.
22. For example, the field of induced pluripotent stem cells has moved forward at a startling pace. See M. Baker, " Fast and Furious," 458, no. 7241 (2009): 962-965. But even in this promising area, significant challenges remain.
23. Neergaard L. " Analysis: Stem Cell Payoff Will Take Decades, Not Days,": Seattle Times. March 16, 2009, http://seattletimes.nwsource.com/html/health/2008866055_apmedstemcellsanalysis.html, last visited March 5, 2010); see also C. Halcom, " Economic Benefits of Stem Cell Research Years Away," , November 10, 2008
24. In addition, the track record of big science delivering on therapeutic promises is not great. See, for example, M. Little, W. Hall, and A. Orlandi, " Delivering on the Promise of Human Stem-Cell Research: What Are the Real Barriers?" 7, no. 12 (2006): 1188-1192, at 1190: " there is skepticism about the likely success of stem-cell research, on the basis of the historical experience of the hyperbole surrounding gene therapy since the early 1970s. As a result, the market has become more cautious about the promises of new technologies." See also L. B. Giebel, " Stem Cells - A Hard Sell to Investors," 23 (2005): 798-800.
25. Hamilton D. " The Biotech Bubble: Why Stem-Cell Research Won't Make States Rich,": Slate Magazine. February 6, 2007, http://www.slate.com/id/2159153/pagenum/all/, See, for example, , last visited March 5, 2010
26. http://www.the-scientist.com/article/display/55372/, In fact, many stem cell companies (such as industry leaders like Advanced Cell Technology and Novocell) are struggling. Some companies have shifted their focus from the development of therapies to the more modest - but immediately relevant - area of research support (e.g., developing the tools, ingredients and supplies necessary for stem cell research); see, E. Dolgin, " Profiting from Pluripotency: How Companies Plan to Make Money (Really) Off of Embryonic Stem Cells," 23, no. 2 (2009): 60,, last visited March 5, 2010
27. See Little et al., note 28, at 1191.
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29. " Stem Cell Innovation at Risk in UK, Studies Find,": Science Daily. April 6, 2009, http://www.sciencedaily.com/releases/2009/04/090406073547.htm, Science News, , last visited March 5, 2010
30. Longaker. See, note 10
31. http://www.publications.parliament.uk/pa/ld199900/ldselect/ldsctech/38/3801.htm, For a discussion of the importance of public trust in the context of research, see House of Lords Select Committee on Science and Technology, , February 23, 2000, at 1.19 (introduction,, last visited March 5, 2010
32. Petersen A. " The Ethics of Expectations: Biobanks and the Promise of Personalised Medicine," Monash Bioethics Review 2009, 28(no. 1):5.1-5.12.
33. Blumenthal D. " Academic-Industrial Relationships in the Life Sciences," New England Journal of Medicine 2003, 349:2452-2459. See, for example, T. Lemmens, " Leopards in the Temple: Restoring Scientific Integrity to the Commercialized Research Scene," 32, no. 4 (2004): 641-657; see Downie and Herder, note 22; J. E. Bekelman, Y. Li, and C. P. Gross, " Scope and Impact of Financial Conflicts of Interest in Biomedical Research: A Systematic Review," 289, no. 4 (2003): 454-465; see Caulfield, note 22; T. Caulfield and B. Williams-Jones, eds., (New York: Kluwer Academic/Plenum Publishing, 1999): at 200; T. Caulfield, " The Commercialization of Human Genetics: A Discussion of Issues Relevant to Canadian Consumers," 21, no. 4 (1999): 483-526; Silversides, note 3
34. For a good review of the evidence associated with many of these issues, see (Bekelman et al.).
35. Some of the stated economic benefits, such as a reduction in the burden of disease and the attraction of top researchers, are not directly related to the commercialization process.
36. See note 19.
37. See Herder and Brian, note 1.
38. See Rowley and Martin, note 32; see also D. Resnik, " The Commercialization of Human Stem Cells: Ethical and Policy Issues," 10, no. 2 (2002): 127-154.
39. Blumenthal D, Campbell E G, Gokhale M, Yucel R, Clarridge B, Hilgartner S, Holtzman N A. " Data Withholding in Genetics and the Other Life Sciences: Prevalences and Predictors," Academic Medicine 2006, 81(no. 2):137-145.
40. Critchley C R. " Public Opinion and Trust in Scientists: The Role of the Research Context, and the Perceived Motivation of Stem Cell Researchers," Public Understanding of Science 2008, 17(no. 3):309-327.
41. (2004) (Proposition 71). Cal Legis Serv Prop 71 (West). Enacted
42. For a review of much of the relevant literature, see T. Caulfield, " Human Gene Patents: Proof of Problems?" 84, no. 1 (2009): 133-145.
43. Bergman K, Graff G. " The Global Stem Cell Patent Landscape," Nature Biotechnology 2007, 25:419-424. See, at 420, where it is reported that there are over 10,000 applications and granted patents related to stem cells technologies
44. Loring J F, Campbell C. " Intellectual Property and Human Embryonic Stem Cell Research," Science 2006, 311(no. 5768):1716-1717. at 1716. See also Winickoff, note 1
45. Caulfield T, Ogbogu U, Murdoch C, Einsiedel E. " Patent, Commercialization and the Canadian Stem Cell Community," Regenerative Medicine 2008, 3(no. 4):483-496. at 485
46. Lei Z, Juneja R, Wright B D. " Patents versus Patenting: Implications of Intellectual Property Protection for Biological Research," Nature Biotechnology 2009, 27:36-40.
47. For example, , H.R. 977, 110th Cong. (2007).
48. Holman C. " Trends in Human Gene Patent Litigation," Science 2008, 322(no. 5899):198-199. http://sippi.aaas.org/Pubs/SIPPI_Four_Country_Report.pdf, T. Caulfield, B. Cook-Deegan, S. Kieff, and J. Walsh, " Evidence and Anecdotes: An Analysis of Human Gene Patenting Controversies," 24 (2006): 1091-1094; C. J. Murdoch and T. Caulfield, " Commercialization, Patenting and Genomics: Researcher Perspectives," 1, no. 2 (2009): 22.1-22.5; J. P. Walsh, W. M. Cohen, and A. Arora, " Patenting and Licensing of Research Tools and Biomedical Innovation," in W. M. Cohen and S. Merrill, eds., (Washington: National Academies Press, 2003): at 285; see also Directorate for Science and Policy Programs American Association for the Advancement of Science, , Project on Science and Intellectual Property in the Public Interest, Directorate for Science and Policy Programs, American Association for the Advancement of Science, Washington, D.C., 2007,, last visited March 5, 2010). This study looked at technologies more broadly and concluded at page 15: " IP-protected technologies remain relatively accessible to the broad scientific community, and not as constrained by IP protections as many have cautioned."
49. Holman C M. " The Impact of Human Gene Patents on Innovation and Access: A Survey of Human Gene Patent Litigation," University of Missouri-Kansas City Law Review 2007, 76:295-361. at 300; also see Caulfield, note 47
50. In the U.S., one could argue that the WARF patents have already had an adverse effect. For example, P. Lee, " The Evolution of Intellectual Infrastructure," 83 (2008): 39-122, at 95, has argued that " several years of exclusive rights have no doubt prevented some downstream research and development from occurring." Others, however, disagree. See, for example, J. Vom Wege Dovi, " Speaking Words of Wisdom: Let It Be. The Reexamination of the Human Embryonic Stem Cell Patents," 12, no. 11 (2008): 107-130, at 120: " It can hardly be true that the WARF patents stifle research. Quite the opposite is true. Scientific progress is accelerated because researchers can use the WARF cells, rather than having to establish their own ES cell lines. Furthermore, the patents act as incentives for scientists to explore other avenues to design around the patents." For a detailed review of the WARF story, see J. M. Golden, " WARF's Stem Cell Patents and Tensions between Public and Private Sector Approaches to Research," 38, no. 2 (2010). The author notes that while the WARF situation may have caused undue expense, " [f]or those who believe in the value of a robust public sector for scientific research, it might be particularly reassuring that the story of WARF's stem cell patents reaffirms that biotechnology's public sector can work to reclaim research areas even when, whether due to conscious policy decision or unconscious mistake, public funding has initially vacated the field." Further, Golden notes: " Whether or not one believes that WARF or Geron should be blamed for managing rights or claims of right in a way that has failed to optimize progress in HESC science, it seems undeniable that the United States patent system has helped to get the ball rolling in the first instance." .
51. Vrtovec K T, Scott C. " Patenting Pluripotence: The Next Battle for Stem Cell Intellectual Property," Nature Biotechnology 2008, 26:393-395. See, for example, and A. Plomer, K. Taymor, and C. Scott, " Challenges to Human Embryonic Stem Cell Patents," 2, no. 1 (2008): 13-17
52. See, generally, Bergman and Graff, note 48; see also Lee, note 41, at 95: " In a sense, stem cells are the quintessential infrastructure, for they retain the ability to differentiate into a wide array of particularized cells and have shown immense promise as the basis for a broad variety of regenerative therapies. Despite only being about half-way through the term of the original patent, consensus has already developed that these assets are critical to a broad range of basic experimentation and applications" (footnotes omitted.).
53. See note 38.
54. See, generally, Winickoff et al., su note 1.
55. http://www.hinxtongroup.org/docs/Hinxton%202006%20consensus%20document.pdf,http://www.isscr.org/guidelines/ISSCRhESCguidelines2006.pdf,http://www.iascr.org/about.shtml, For e.g., see The Hinxton Group, An International Consortium on Stem Cells, Ethics & Law, , February 24, 2006,, last visited March 5, 2010): " Insofar as hESC lines are a precious resource and replication and scientific collaboration are vital to scientific advancement, we encourage scientists conducting stem cell research to submit any stem cell lines they derive to national or international depositories that subscribe to internationally accepted standards of quality and make cell lines and data (e.g. DNA fingerprinting and microsatellite data) publicly available" (at para. 8); see also International Society for Stem Cell Research, , December 21, 2006,, last visited March 5, 2010), at 10-11; see also Interstate Alliance on Stem Cell Research (IASCR), " Objectives," , last visited March 5, 2010): " IASCR objectives include the development of mechanisms for data and material sharing."
56. See Caulfield et al., note 51.
57. Campbell E G, Clarridge B R, Gokhale M. " Data Withholding in Academic Genetics: Evidence from a National Survey," JAMA 2002, 287(no. 4):473-480. D. Blumenthal, E. G. Campbell, M. S. Anderson, N. Causino, and K. S. Louis, " Withholding Research Results in Academic Life Science: Evidence from a National Survey of Faculty," 277, no. 15 (1997): 1224-1228.
58. Hong W, Walsh J. " For Money or Glory?: Commercialization, Competition, and Secrecy in the Entrepreneurial Universities," Sociological Quarterly 2009, 50(no. 1):145-171. at abstract, where the authors conclude thus: " Our research highlights the central role that scientists' competition for priority plays in the system of science and that, while such competition spurs effort, it also produces negative effects that recent trends toward commercialization of academic science seem to be exacerbating."
59. Also, thank you to John Walsh for his assistance in the interpretation of the research; personal communication with author, April 28, 2009
60. Bubela T, Strotmann A. Designing Metrics for Impacts and Social Benefits of Publicly Funded Research: Working Paper: The International Expert Group on Biotechnology, Innovation and Intellectual Property. 2008, http://www.theinnovationpartnership.org/data/ieg/documents/cases/TIP_Innovation_Metrics_Case_Study.pdf, last visited March 5, 2010). See specifically, " Collaboration and Commercialization in Stem Cell Research: A Case Study," at 5-17. Bubela and Strotmann conclude that " a culture of commercialization (measured by numbers of patents held) had a significant negative impact on collaboration patterns as measured by at least two network statistics, including the number of distinct collaborators that a researcher has. These effects were observed even after a number of other variables were taken into account that are highly predictive of collaborative behaviour," at 17
61. at 17. The relatively recent push for open access to stem cell lines is an indication of both the research community recognition of the importance of collaborative interactions and the fact that there might be a problem brewing. See, for example, P. L. Taylor, " Research Sharing, Ethics and Public Benefit," 25 (2007): 398-401; this paper notes the importance of the guidance issued by the ISSCR regarding the sharing of data
62. Chalmers D, Nicol D. " Commercialisation of Biotechnology: Public Trust and Research," International Journal of Biotechnology 2006, 6:116-133.
63. Caulfield T, Einsiedel E, Merz J, Nicol D. " Trust, Patents, and Public Perceptions: The Governance of Controversial Biotechnology Research," Nature Biotechnology 2006, 24:1352-1354. See, generally
64. International Public Opinion Research on Emerging Technologies: Canada-US Survey Results 2005, Canadian Biotechnology Secretariat, Ottawa, Industry Canada
65. Williams C. " Australian Attitudes to DNA Sample Banks and Genetic Screening," Current Medical Research and Opinion 2005, 21(no. 11):1773-1775. See, for example, at 1774 where it was found that " 75% indicated concerns over commercialization and access to information by health insurance companies" ; and K. Hoeyer et al., " Informed Consent and Biobanks: A Population-based Study of Attitudes towards Tissue Donation for Genetic Research," 32, no. 3 (2004): 224-229, at 227, where it is reported that avoiding the influence of " corporate interest" was one of the most important issues for the public. See also M. Levitt and S. Weldon, " A Well Placed Trust?: Public Perceptions of the Governance of DNA Databases," 15, no. 4 (2005): 311-321, at 315
66. See Critchley, note 45.
67. at 324. See also a recent study by H. Liu and S. Priest, " Understanding Public Support for Stem Cell Research: Media Communication, Interpersonal Communication and Trust in Key Actors," 18, no. 6 (2009): 704-718, at 716. They found that " trust in university scientists is making a very positive contribution to the benefit perception."