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Stem Cell Research as Innovation: Expanding the Ethical and Policy Conversation

Published online by Cambridge University Press:  01 January 2021

Extract

In 1998, researchers established the first human embryonic stem cell line. Their scientific triumph triggered an ethics and policy argument that persists today. Bioethicists, religious leaders, government officials, patient advocates, and scientists continue to debate whether this research poses a promise, a threat, or a mixed ethical picture for society.

Scientists are understandably excited about the knowledge that could come from studying human embryonic stem cells. Most of them believe these cells offer a precious opportunity to learn more about why diseases develop and how they might be prevented or attacked. In their quest to gain support for stem cell research, scientists and others have claimed that the research could generate cures and treatment for everything from heart disease to cancer.

Type
Symposium
Copyright
Copyright © American Society of Law, Medicine and Ethics 2010

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References

See for example Weiss, R., “Stem Cell Bill Easily Clears Senate but Lacks Votes to Override a Veto,” Washington Post, April 12, 2007; Smith, S., Neaves, W., and Teitelbaum, S., “Adult Stem Cell Treatments for Diseases?” Science 313, no. 5786 (2006): 439; Enserink, M., “Selling the Stem Cell Dream,” Science 313, no. 5784 (2006): 160163; Applebaum, A., “Stem Cell Stumping,” Washington Post, August 4, 2004.Google Scholar
Couzin, J., “Celebration and Concern over U.S. Trial of Embryonic Stem Cells,” Science 323, no. 5914 (2009): 568.CrossRefGoogle Scholar
Vogel, G, “Ready or Not? Human ES Cells Head Toward the Clinic,” Science 308, no. 5728 (2005): 15341538.Google Scholar
See Normile, D., Vogel, G., and Couzin, J., “South Korean Team's Remaining Human Stem Cell Claims Demolished,” Science 311, no. 5758 (2006): 156157.CrossRefGoogle Scholar
Solter, D., “Politically Correct Human Embryonic Stem Cells?” New England Journal of Medicine 354, no. 11 (2006): 1209.Google Scholar
National Institutes of Health, “Stem Cell Basics,” April 28, 2009, available at <http://stemcells.nih.gov/info/basics/defaultpage> (last visited March 11, 2010).+(last+visited+March+11,+2010).>Google Scholar
See National Institutes of Health, supra note 6, at 17. See also Demick, B., “Hopes Founder on ‘Big Lie,’” Los Angeles Times, January 9, 2006.Google Scholar
Martin, T. J., “Reactions to the Hwang Scandal,” Science 311, no. 5761 (2006): 607; Couzin, J., “… And How the Problems Eluded Peer Reviewers,” Science 311, no. 5757 (2006): 2324.Google Scholar
Holden, C., “Battle Heats Up Over Cloning,” Science 295, no. 5552 (2002): 2009.Google Scholar
Gramling, C., “Random Samples: People,” Science 309, no. 5742 (2005): 1937; Paarlberg, R. L., “The Great Stem Cell Race,” Foreign Policy (May-June 2005): 4451.Google Scholar
See Holden, C., “States, Foundations Lead the Way After Bush Vetoes Stem Cell Bill,” Science 313, no. 5786 (2006): 420421; Paarlberg, R., “The Great Stem Cell Race,” at 4951.CrossRefGoogle Scholar
Okie, S., “Stem-Cell Politics,” New England Journal of Medicine 355, no. 16 (2006): 16331637.CrossRefGoogle Scholar
“Kerry's Acceptance: ‘We Have It in Our Power to Change the World Again,’” New York Times, July 30, 2004; “Ron Reagan's Speech to the Democratic National Convention,” New York Times, July 27, 2004; Editorial, “Better to be Talked About …,” Nature 431, no. 7006 (2004): 229.CrossRefGoogle Scholar
Editorial, “Stem Cell Politics,” Washington Post, January 13, 2006; Connolly, C., “Waging the Battle for Stem Cell Research,” Washington Post, June 9, 2002.Google Scholar
See “Stem Cell Research Advocates Concerned McCain Will Backtrack on Support If Elected President,” September 23, 2008, available at <http://www.medicalnewstoday.com/printerfriendlynews.php?newsid=122493> (last visited March 11, 2010).+(last+visited+March+11,+2010).>Google Scholar
See Holden, C., “Scientists Look to Missouri to Show the Way for Stem Cells,” Science 314, no. 5800 (2006): 737738; Franck, M., “Stem Cell Fight Shatters Spending Records,” St. Louis Post-Dispatch (October 17, 2006); Mannies, J., “Talent, McCaskill Put Contrasts on Display During Debate,” St. Louis Post-Dispatch (October 11, 2006); Citizens for Barbara Fraser for County Council, “Fresh Idea #1: St. Louis County Will Benefit from Stem Cell Research,” Campaign Brochure (2006).Google Scholar
Sulmasy, D. P., “Deliberative Democracy and Stem Cell Research in New York State: The Good, the Bad, and the Ugly,” Kennedy Institute of Ethics Journal 19, no. 1 (2009): 6378.CrossRefGoogle Scholar
See Malakoff, D., “The Calculus of Making Stem Cells a Campaign Issue,” Science 305, no. 5685 (2004): 760.CrossRefGoogle Scholar
See, e.g., Kiatpongsan, S. and Sipp, D., “Monitoring and Regulating Offshore Stem Cell Clinics,” Science 323, no. 5921 (2009): 15641565; Shaywitz, D., “Stem Cell Hype and Hope,” Washington Post, January 12, 2006.CrossRefGoogle Scholar
Wilson, J. M., “A History Lesson for Stem Cells,” Science 324, no. 5928 (2009): 727728.CrossRefGoogle Scholar
See, e.g., Wade, N., “Rethink Stem Cells? Science Already Has,” New York Times, March 10, 2009.Google Scholar
See Wilson, , supra note 20, at 728 (describing media coverage of the clinical trial).Google Scholar
Harris, G., “Pick to Lead Health Agency Draws Praise and Some Concern,” New York Times, July 9, 2009.Google Scholar
Wade, N., “Some Scientists See Shift in Stem Cell Hopes,” New York Times, August 14, 2006; Weiss, R., “Harvard Announces Private Project to Make Human Stem Cells,” Washington Post, June 7, 2006.Google Scholar
Working Group on Setting Research Priorities, Setting Research Priorities at the National Institutes of Health, NIH Publication No. 97–4265 (1997): at 8–9. Stem cell research, like a substantial percentage of the studies NIH funds, comes under the heading of basic science. Basic science studies investigate problems in biology potentially relevant to many health conditions. But in response to pressure from Congress and advocacy organizations concerned about funding allocation, NIH requires researchers submitting basic science study proposals to describe the specific health applications of their work. Officials use this information to produce annual estimates of the support it gives to research on different medical conditions. These estimates have limited utility, however, because they combine general research categories, such as stem cell research, with specific disease categories, such as Alzheimer's disease. In addition, funded projects may be listed in more than one category. Critics say that the loose categorization system functions to give NIH officials substantial discretion over where the money actually goes. For estimates covering fiscal years 2005–2010, see “Estimates of Funding for Various Research, Condition, and Disease Categories,” January 15, 2009, available at <http://report.nih.gov/rcdc/categories/PFSummaryTable.aspx> (last visited March 12, 2010). (last visited March 12, 2010).' href=https://scholar.google.com/scholar?q=Working+Group+on+Setting+Research+Priorities,+Setting+Research+Priorities+at+the+National+Institutes+of+Health,+NIH+Publication+No.+97–4265+(1997):+at+8–9.+Stem+cell+research,+like+a+substantial+percentage+of+the+studies+NIH+funds,+comes+under+the+heading+of+basic+science.+Basic+science+studies+investigate+problems+in+biology+potentially+relevant+to+many+health+conditions.+But+in+response+to+pressure+from+Congress+and+advocacy+organizations+concerned+about+funding+allocation,+NIH+requires+researchers+submitting+basic+science+study+proposals+to+describe+the+specific+health+applications+of+their+work.+Officials+use+this+information+to+produce+annual+estimates+of+the+support+it+gives+to+research+on+different+medical+conditions.+These+estimates+have+limited+utility,+however,+because+they+combine+general+research+categories,+such+as+stem+cell+research,+with+specific+disease+categories,+such+as+Alzheimer's+disease.+In+addition,+funded+projects+may+be+listed+in+more+than+one+category.+Critics+say+that+the+loose+categorization+system+functions+to+give+NIH+officials+substantial+discretion+over+where+the+money+actually+goes.+For+estimates+covering+fiscal+years+2005–2010,+see+“Estimates+of+Funding+for+Various+Research,+Condition,+and+Disease+Categories,”+January+15,+2009,+available+at++(last+visited+March+12,+2010).>Google Scholar
See Dresser, R., “Private-Sector Research Ethics: Marketing or Good Conflicts Management?” Theoretical Medicine and Bioethics 27, no. 2 (2006): 115–39.CrossRefGoogle Scholar
See Hegde, D. and Mowery, D., “Politics and Funding in the U.S. Public Biomedical R&D System,” Science 322, no. 5909 (2008): 17971798. I address these issues in depth in Dresser, R., When Science Offers Salvation: Patient Advocacy and Research Ethics (Oxford University Press, 2001). See also Callahan, D., What Price Better Health? Hazards of the Research Imperative (University of California Press, 2003). For an analysis and critique of NIH priority setting, see Institute of Medicine, Scientific Opportunities and Public Needs: Improving Priority Setting and Public Input at the National Institutes of Health (Washington, D.C.: National Academy Press, 1998).Google Scholar
See generally Gostin, L., “Why Rich Countries Should Care about the World's Least Healthy People,” JAMA 298, no. 1 (2007): 8991.CrossRefGoogle Scholar
Hall, S., Merchants of Immortality: Chasing the Dream of Human Life Extension (New York: Houghton Mifflin, 2003); Wade, N., “Apostle of Regenerative Medicine Foresees Longer Health and Life,” New York Times, December 18, 2001.Google Scholar
See Callahan, , supra note 28, at 32, 73–84, 232, 266, 275.Google Scholar
Faden, R. et al., “Public Stem Cell Banks: Considerations of Justice in Stem Cell Research and Therapy,” Hastings Center Report 33, no. 6 (2003): 1327, note 2.CrossRefGoogle Scholar
See Shannon, T., “From the Micro to the Macro,” in The Human Embryonic Stem Cell Debate, edited by Holland, S., Lebacqz, K., and Zoloth, L. (Cambridge: MIT Press, 2001): 177–84.Google Scholar
See Huang, F. and Stremlau, M., “Disease Researchers Neglecting World Poor,” Los Angeles Times, April 30, 2002.Google Scholar
Utzinger, J. and de Savigny, D., “Control of Neglected Tropical Diseases: Integrated Chemotherapy and Beyond,” PLoS Medicine 3, no. 5 (May 2006): e112.CrossRefGoogle Scholar
See Callahan, , supra note 28, at 262.Google Scholar
See “AAAS President Calls to Restore American Health System,” February 13, 2003, available at <http://eurekalert.org/pub_releases/2003-02/aaft-apc020303.php> (last visited March 12, 2010).+(last+visited+March+12,+2010).>Google Scholar
Callahan, D., “The ‘Research Imperative’: Is Research a Moral Obligation?” President's Council on Bioethics Meeting, July 24, 2003, available at <http://bioethicsprint.bioethics.gov/tran-scripts/july03/session1.html> (last visited March 12, 2010).Google Scholar
See generally DeGrazia, D., “Single Payer Meets Managed Competition,” Hastings Center Report 38, no. 1 (2008): 2333.CrossRefGoogle Scholar
See generally Grady, D., “Where Life's Start Is a Deadly Risk,” New York Times, May 24, 2009; Cohen, J., “The New World of Global Health,” Science 311, no. 5758 (2006): 162–67.Google Scholar
See Callahan, , supra note 28, at 268–276. For a general critique of the U.S. approach to biomedical research funding, see Dresser, R., “Priority Setting in Biomedical Research,” AMA Journal of Ethics 11, no. 4 (2009): 322325, available at <http://www.virtualmentor.org> (last visited March 12, 2010).Google Scholar
Goldstein, A., “A President Presses Senate to Ban All Human Cloning,” Washington Post, April 11, 2002.Google Scholar
See Strode, T., “Pro-Lifers Criticize Report by President's Bioethics Council,” BPNews, April 4, 2004, available at <http://bpnews.net/BPnews.asp?ID=17986> (last visited March 12, 2010).Google Scholar
See “Better To Be Talked About…,” supra note 13, at 229.Google Scholar
Alter, J., “The ‘Pro-Cure’ Movement,” Newsweek, June 6, 2005, at 27.Google Scholar
Vogelstein, B., Alberts, B., and Shine, K., “Please Don't Call It Cloning!” Science 295, no. 5558 (2002): 1237.CrossRefGoogle Scholar
President's Council on Bioethics, Human Cloning and Human Dignity: An Ethical Inquiry, 2002, at 41–63, available at <http://bioethics.georgetown.edu.pcbe/reports.cloningre-port/> (last visited March 24, 2010). (last visited March 24, 2010).' href=https://scholar.google.com/scholar?q=President's+Council+on+Bioethics,+Human+Cloning+and+Human+Dignity:+An+Ethical+Inquiry,+2002,+at+41–63,+available+at++(last+visited+March+24,+2010).>Google Scholar
See, e.g., “DeGette and Castle Respond to NIH Guidelines,” July, 6, 2009, available at <http://degette.house.gov/index.php?option=com_content&view=article&id=787:degette-and-castle-respond-to-nih-guidelines&catid=89:health> (last visited March 12, 2010).+(last+visited+March+12,+2010).>Google Scholar
Thompson, D. and Gutmann, A., Why Deliberative Democracy? (Princeton University Press, 2004): at 34.Google Scholar
Id., at 4.Google Scholar
Id., at 57.Google Scholar
Id., at 8690.Google Scholar
Id., at 86.Google Scholar
Id., at 7.Google Scholar
Scientists are getting closer to developing alternative sources of stem cells that could dispense with the need to destroy embryos to obtain such cells. See Vogel, G., “Reprogramming Cells,” Science 322, no. 5884 (2008): 17661767. If this happens, it is possible that officials will decide to limit government support to research on stem cell lines created using methods that avoid embryo destruction.CrossRefGoogle Scholar
“Obama's Remarks on Stem Cell Research,” March 9, 2009, available at <http://www.nytimes.com/2009/03/09/us/politics/09text-obama.html> (last visited July 13, 2009). For commentary on the lack of robust moral argument in the remarks, see Steinfels, P., “In Stem Cell Debate, Moral Suasion Comes Up Short,” New York Times, March 14, 2009.Google Scholar
See “Obama's Remarks on Stem Cell Research,” supra note 56.Google Scholar
National Institutes of Health Guidelines on Human Stem Cell Research, available at <http://stemcells.nih.gov/policy/2009guidelines.htm> (last visited March 12, 2010).+(last+visited+March+12,+2010).>Google Scholar
Id., at 3.Google Scholar
Kington, R., Stem Cell Press Briefing, July 6, 2009. See also Trapp, D., “NIH Lifts Main Stem Cell Funding Restrictions,” American Medical News, July 27, 2009.Google Scholar
For an analysis applying deliberative democracy principles to New York's approach to human embryonic stem cell research, see Sulmasy, , supra note 17.Google Scholar
See Steinfels, , supra note 56 (quoting one congressional representative who “equated opposition to embryonic stem cell research with refusing ‘a cure for your child's cancer’” and another who said such opposition was equivalent to “a sentence of death of millions of Americans”).Google Scholar
Annas, G., Caplan, A., and Elias, S., “Stem Cell Politics, Ethics, and Moral Progress,” Nature Medicine 5, no. 12 (1999): 13391341.CrossRefGoogle Scholar
Schechter, A. and Rettig, R., “Funding Priorities for Medical Research,” JAMA 288, no. 7 (2002): 832.CrossRefGoogle Scholar
Kass, L., “Foreword,” in President's Council on Bioethics, Human Cloning and Human Dignity, at XIII-XXIII.Google Scholar