Hostname: page-component-586b7cd67f-rcrh6 Total loading time: 0 Render date: 2024-11-28T16:29:02.241Z Has data issue: false hasContentIssue false
  • English
  • Français

Will Embryonic Stem Cells Change Health Policy?

Published online by Cambridge University Press:  01 January 2021

William M. Sage
Get access Rights & Permissions [Opens in a new window]

Extract

Essays on stem cell policy seem to fall into three categories. Some essays in this collection are about logic and principles. Others are about practices and beliefs. The former group draws lines and defends them, a normative project. The latter group attempts to explain the lines that already exist, a descriptive project that may have important normative goals. Still other essays, by scientists, are about growing stem cell lines instead of drawing them.

The purpose of this essay is to situate the lines being drawn around stem cell science in the larger landscape of health policy. I am interested in the things that cause health policy to take particular directions and the consequences of those directions for cost, access, and quality — all of which are determined in part by biomedical innovations such as those potentially derived from stem cells.

Type
Symposium
Information
Journal of Law, Medicine & Ethics , Volume 38 , Issue 2 , Summer 2010 , pp. 342 - 351
Copyright
Copyright © American Society of Law, Medicine and Ethics 2010

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

Brock, D. W., “Creating Embryos for Use in Stem Cell Research,” Journal of Law, Medicine & Ethics 38, no. 2 (2010).Google Scholar
See, e.g., Green, R. M., “Political Interventions in U.S. Human Embryo Research: An Ethical Assessment,” Journal of Law, Medicine & Ethics 38, no. 2 (2010).CrossRefGoogle Scholar
See, e.g., Goldstein, L., “Why Scientific Details Are Important When Novel Technologies Encounter Law, Politics, and Ethics,” Journal of Law, Medicine & Ethics 38, no. 2 (2010).CrossRefGoogle Scholar
Sage, W. M., “Malpractice Insurance and the Emperor's Clothes,” DePaul Law Review 54, no. 2 (2005): 463–484.Google Scholar
Marmor, T., The Politics of Medicare, 2nd ed. (New Brunswick, NJ: AldineTransaction, 2000); Hyman, D., Medicare Meets Mephistopheles (Washington, D.C.: Cato Institute, 2006).Google ScholarPubMed
California Institute for Regenerative Medicine, “CIRM Creates a Unique Environment for Stem Cell Research in California,” available at <http://www.cirm.ca.gov/StemCellBasics_California> (last visited April 20, 2010).+(last+visited+April+20,+2010).>Google Scholar
California Institute for Regenerative Medicine, All 12 CIRM Major Facility Projects Moving Forward, Creating Jobs Today and Hope for Cures Tomorrow, Press Release, available at <http://www.cirm.ca.gov/PressRelease_011510> (last visited April 20, 2010).+(last+visited+April+20,+2010).>Google Scholar
Kahan, D. M., Braman, D., and Mandel, G. N., “Risk and Culture: Is Synthetic Biology Different?” February 2009, available at <http://papers.ssrn.com/sol3/papers.cfm?abstract_id=1347165> (last visited April 20, 2010).CrossRef+(last+visited+April+20,+2010).>Google Scholar
Vladeck, B. C., “The Political Economy of Medicare,” Health Affairs 18, no. 1 (1999): 22–36.CrossRefGoogle Scholar
Executive Order No. 13,505, Federal Register 74 (March 11, 2009): 10,667–10,668.Google Scholar
Sage, W. M., “Fraud and Abuse Law,” JAMA 281, no. 12 (1999): 1179–1181.CrossRefGoogle Scholar
Spar, D. and Harrington, A., “Selling Stem Cell Science: How Markets Drive the Law along the Technological Frontier,” American Journal of Law and Medicine 33, no. 4 (2007): 541–565.Google Scholar
Jensen, J., Hyllner, J., and Bjorquist, P., “Human Embryonic Stem Cell Technologies and Drug Discovery,” Journal of Cellular Physiology 219, no. 3 (2009): 513–519.CrossRefGoogle Scholar
Kola, I. and Landis, J., “Can the Pharmaceutical Industry Reduce Attrition Rates?” Nature Reviews Drug Discovery 3, no. 8 (2004): 711–715.Google Scholar
Lazarou, J., Pomeranz, B. H., and Corey, P. N., “Incidence of Adverse Drug Reactions in Hospitalized Patients: A Meta-analysis of Prospective Studies,” JAMA 279, no. 15 (1998): 1200–1205.CrossRefGoogle Scholar
Prentis, R. A., Lis, Y., and Walker, S. R., “Pharmaceutical Innovation by the Seven UK-Owned Pharmaceutical Companies (1964–1985),” British Journal of Clinical Pharmacology 25, no. 3 (1988): 387–396.CrossRefGoogle Scholar
Améen, C., Strehl, R., Björquist, P., Lindahl, A., Hyllner, J., and Sartipy, P., “Human Embryonic Stem Cells: Current Technologies and Emerging Industrial Applications,” Critical Reviews in Oncology/Hematology 65, no. 1 (2008): 54–80.CrossRefGoogle Scholar
Clarke, S. E. and Jeffrey, P., “Utility of Metabolic Stability Screening: Comparison of In Vitro and In Vivo Clearance,” Xenobiotica 31, nos. 8–9 (2001): 591–598.CrossRefGoogle Scholar
Shah, R. R., “The Significance of QT Interval in Drug Development,” British Journal of Clinical Pharmacology 54, no. 2 (2002): 188–202.CrossRefGoogle Scholar
Meinardi, M. T., Gietema, J. A., van Veldhuisen, D. J., van der Graaf, W. T., de Vries, E. G., and Sleijfer, D. T., “Long-Term Chemotherapy-Related Cardiovascular Morbidity,” Cancer Treatment Reviews 26, no. 6 (2000): 429–447.Google Scholar
Schwartz, R. E., Linehan, J. L., Painschab, M. S., Hu, W. S., Verfaillie, C. M., and Kaufman, D. S., “Defined Conditions for Development of Functional Hepatic Cells from Human Embryonic Stem Cells,” Stem Cells and Development 14, no. 6 (2005): 643–655.CrossRefGoogle Scholar
Dolnikov, K., Shilkrut, M., and Zeevi-Levin, N. et al., “Functional Properties of Human Embryonic Stem Cell-Derived Cardiomyocytes,” Annals of New York Academy of Sciences 1047 (June 2005): 66–75.CrossRefGoogle Scholar
Kehat, I., Kenyagin-Karsenti, D., and Snir, M. et al., “Human Embryonic Stem Cells Can Differentiate into Myocytes with Structural and Functional Properties of Cardiomyocytes,” Journal of Clinical Investigation 108, no. 3 (2001): 407–414.CrossRefGoogle Scholar
Takahashi, K. and Yamanaka, S., “Induction of Pluripotent Stem Cells from Mouse Embryonic and Adult Fibroblast Cultures by Defined Factors,” Cell 126, no. 4 (2006): 663–676. The original iPSC experiment reprogrammed adult skin cells to a pluripotent state similar to that of hESCs.Google Scholar
Dimos, J., Rodolfa, K. T., and Niakan, K. K. et al., “Induced Pluripotent Stem Cells Generated from Patients with ALS Can Be Differentiated into Motor Neurons,” Science 321, no. 5893 (2008): 1218–1221.Google Scholar
Golden, J. M., “WARF's Stem Cell Patents and Tensions between Public and Private Sector Approaches to Research,” Journal of Law, Medicine & Ethics 38, no. 2 (2010).CrossRefGoogle Scholar
Sage, W. M., “Some Principles Require Principals: Why Banning ‘Conflicts of Interest’ Won't Solve Incentive Problems in Biomedical Research,” Texas Law Review 85, no. 6 (2007): 1413–1463.Google Scholar
Berg, P., “Asilomar 1975: DNA Modification Secured,” Nature 455, no. 7211 (2008): 290–291.CrossRefGoogle Scholar
Thomas, L., The Lives of a Cell: Notes of a Biology Watcher (New York: Penguin, 1978): at 5–42.Google Scholar
Shapiro, A. M., Lakey, J., Ryan, E., Korbutt, G., Toth, E., Warnock, G., Kneteman, N., and Rajotte, R., “Islet Transplantation in Seven Patients with Type 1 Diabetes Mellitus Using Glucocorticoid-Free Immunosuppressive Regimen,” New England Journal of Medicine 343, no. 4 (2000): 230–238.CrossRefGoogle Scholar
Shapiro, A. M., Ricordi, C., Hering, B. J., Auchincloss, H., Lindblad, R., Robertson, R. P., Secchi, A., Brendel, M. D., Berney, T., and Brennan, D. C. et al., “International Trial of the Edmonton Protocol for Islet Transplantation,” New England Journal of Medicine 355, no. 13 (2006): 1318–1330.CrossRefGoogle Scholar
Soria, B., Roche, E., Berna, G., Leon-Quinto, T., Reig, J. A., and Martin, F., “Insulin-Secreting Cells Derived from Embryonic Stem Cells Normalize Glycemia in Streptozotocin-Induced Diabetic Mice,” Diabetes 49, no. 2 (2000): 157–162.CrossRefGoogle Scholar
Soria, B., “In-Vitro Differentiation of Pancreatic Beta-Cells,” Differentiation 68, nos. 4–5 (2001): 205–219.CrossRefGoogle Scholar
Segev, H., Fishman, B., Ziskind, A., Shulman, M., and Itskovitz-Eldor, J., “Differentiation of Human Embryonic Stem Cells into Insulin-Producing Clusters,” Stem Cells 22, no. 3 (2004): 265–274.CrossRefGoogle Scholar
Zhou, Q., Brown, J., Kanarek, A., Rajagopal, J., and Melton, D., “In Vivo Reprogramming of Adult Pancreatic Exocrine Cells to β-Cells,” Nature 455, no. 7213 (2008): 627–632.CrossRefGoogle Scholar
National Eye Institute, “Prevalence of Age-Related Macular Degeneration in the United States,” available at <http://www.nei.nih.gov/eyedata/pbd4.asp> (last visited April 21, 2010).+(last+visited+April+21,+2010).>Google Scholar
A recent study supported the safety and effectiveness of implanting hESC-RPE cells into the sub-retinal space of rats. The study demonstrated the ability of hESC-RPE cells to survive after transplantation for more than 8 months and showed a dose-dependent improvement in visual acuity and luminance threshold response. Just as importantly, there was no evidence of pathological consequences or teratoma formation, clearing the way for potential Phase I clinical trials. Lu, B., Malcuit, C., and Wang, S. et al., “Long-Term Safety and Function of RPE from Human Embryonic Stem Cells in Preclinical Models of Macular Degeneration,” Stem Cells 27, no. 9 (2009): 2126–2135.CrossRefGoogle Scholar
Kaplan, K., “Company Seeks FDA Permission to Conduct Clinical Trial Using Human Embryonic Stem Cells,” available at <http://latimesblogs.latimes.com/booster_shots/2009/11/human-embyronic-stem-cells-stargardts-macular-dystrophy.html> (last visited April 21, 2010).+(last+visited+April+21,+2010).>Google Scholar
Geron, , Geron Comments on FDA Hold on Spinal Cord Injury Trial, Press Release, <http://www.geron.com/media/pressview.aspx?id=1188> (last visited April 21, 2010).Google Scholar
Keirstead, H., Nistor, G., Bernal, G., Totoiu, M., Cloutier, F., Sharp, S., and Steward, O., “Human Embryonic Stem Cell-Derived Oligodendrocyte Progenitor Cell Transplants Remyelinate and Restore Locomotion After Spinal Cord Injury,” Journal of Neuroscience 25, no. 19 (2005): 4694–4705.CrossRefGoogle Scholar
Dresser, R., “Stem Cell Research as Innovation: Expanding the Ethical and Policy Conversation,” Journal of Law, Medicine & Ethics 38, no. 2 (2010).CrossRefGoogle Scholar
Gersh, B. J., Simari, R. D., Behfar, A., Terzic, C. M., and Terzic, A., “Cardiac Cell Repair Therapy: A Clinical Perspective,” Mayo Clinic Proceedings 84, no. 10 (October 2009): 876–892.CrossRefGoogle Scholar
United Network for Organ Sharing, available at <http://www.unos.org> (last visited April 21, 2010).+(last+visited+April+21,+2010).>Google Scholar
Mayo Clinic, “Transplant Programs at Mayo Clinic,” available at <http://www.mayoclinic.org/transplant/organ-donation.html> (last visited April 21, 2010).+(last+visited+April+21,+2010).>Google Scholar
Zhu, W. Z., Hauch, K. D., Xu, C., and Laflamme, M. A., “Human Embryonic Stem Cells and Cardiac Repair,” Transplatation Reviews 23, no. 1 (January 2009): 53–68.CrossRefGoogle Scholar
Id. New procedures to induce cardiogenesis and enrich cardio-myocite cultures have resulted in hESC-CM preparations with greater than 93% purity and greater than 85% viability, greatly reducing safety and scalability concerns.Google Scholar
Laflamme, M. A., Chen, K. Y., and Naumova, A. V. et al., “Cardiomyocytes Derived from Human Embryonic Stem Cells in Pro-survival Factors Enhance Function of Infarcted Rat Hearts,” Nature Biotechnology 25, no. 9 (2007): 1015–1024.CrossRefGoogle Scholar
Abdel-Latif, A., Bolli, R., and Tleyjeh, I. M. et al., “Adult Bone Marrow-Derived Cells for Cardiac Repair: A Systematic Review and Meta-Analysis,” Archives of Internal Medicine 167, no. 10 (2007): 989–997; Hristov, M., Heussen, N., Schober, A., and Weber, C., “Intracoronary Infusion of Autologous Bone Marrow Cells and Left Ventricular Function After Acute Myocardial Infarction: A Meta-analysis,” Journal of Cellular and Molecular Medicine 10, no. 3 (2006): 727–733; Lipinski, M. J., Biondi-Zoccai, G. G., and Abbate, A. et al., “Impact of Intracoronary Cell Therapy on Left Ventricular Function in the Setting of Acute Myocardial Infarction: A Collaborative Systematic Review and Meta-analysis of Controlled Clinical Trials,” Journal of the American College of Cardiology 50, no. 18 (October 30, 2007): 1761–1767; Martin-Rendon, E., Brunskill, S. J., Hyde, C. J., Stanworth, S. J., Mathur, A., and Watt, S. M., “Autologous Bone Marrow Stem Cells to Treat Acute Myocardial Infarction: A Systematic Review,” European Heart Journal 29, no. 15 (August 2008): 1807–1818.CrossRefGoogle Scholar
See Gersh, et al., supra note 42.Google Scholar
Richardson, L. S., “Criminal Law: When Human Experimentation Is Criminal,” Journal of Criminal Law and Criminology 99, no. 2 (2009): 89–133.Google Scholar
Jacobs, L. R., “The Politics of America's Supply State: Health Reform and Medical Technology,” Health Affairs 14, no. 2 (1995): 143–157; Sage, W. M., “Relational Duties, Regulatory Duties, and the Widening Gap between Individual Health Law and Collective Health Policy,” Georgetown Law Journal 96, no. 2 (2008): 497–522.CrossRefGoogle Scholar