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Selling Stem Cell Science: How Markets Drive Law along the Technological Frontier
Published online by Cambridge University Press: 06 January 2021
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Since 2001, stem cell science in the United States has been explicitly constrained by federal prohibitions. Under an executive order announced by President George W. Bush on August 9 of that year, U.S. researchers can only receive federal funding for work done on the limited number of embryonic stem cell lines (an estimated sixty to sevent-eight) created prior to the executive order. Continued research on embryonic stem cells (ESCs) is not expressly prohibited. But, under the Bush administration's executive order, no federal funds can be used to develop new embryonic stem cells lines, or even to work on new lines developed after August 2001.
The problems with these restrictions, according to their critics, are threefold. First, they sharply limit the funds available to a high-cost, early-stage endeavor, limiting the pace of scientific discovery in the process. Second, they force stem cell researchers to maintain an administratively absurd line between research conducted in federally-funded laboratories (which include most university facilities) and that conducted in spaces free of federal funds.
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References
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94 45 C.F.R. § 46.203 (1975).
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115 Id.
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133 Sheryl Gay Stolberg, First Bush Veto Maintains Limits on Stem Cell Use, N.Y. Times, July 20, 2006, at A1.
134 Id.
135 Id.
136 Fifty-one Republicans, 183 Democrats and one independent comprised the 235 voting in favor of the bill while four Democrats and 179 Republicans voted against. Id.
137 Id.
138 Scott, supra note 96, at 152 (“The 1974 action had surprising staying power. With one short-lived exception, the ‘temporary’ moratorium has passed its thirtieth anniversary – no government funds are allowed for embryo research, a policy that swept essential questions about infertility, reproductive medicine, prenatal diagnosis, and embryonic stem cell research beyond the reach of most American clinicians and scientists.”).
139 Id.
140 National Institutes of Health Revitalization Act of 1993, 42 U.S.C. § 289g (2006).
141 The President’s Council on Bioethics, supra note 92, at 24.
142 Judith A. Johnson, Congressional Research Service, Human Cloning, (2001), available at http://fpc.state.gov/documents/organization/7943.pdf#search=%22Executive%2 0Order%20%22December%202%2C%201994%22%22. See generally National Institute of Health, Report of the Human Embryo Research Panel (1994).
143 Johnson, supra note 142, at 4.
144 John Schwartz & Ann Devroy, Clinton to Ban U.S. Funds For Some Embryo Studies, Wash. Post, Dec. 3, 1994, at A1.
145 Id.
146 Department of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2006, Pub. L. 109-149, § 509, 119 Stat. 2833, 2880 (2005).
147 Id.
148 Id.
149 The President’s Council on Bioethics, supra note 92, at 25.
150 Press Release, The White House, Prohibition on Federal Funding for Cloning of Human Beings (Mar. 4, 1997), available at http://grants.nih.gov/grants/policy/cloning_direct ive.htm.
151 Id.
152 Nat’l Bioethics Advisory Comm’n, Cloning Human Beings: Report and Recommendations of the National Bioethics Advisory Commission 2 (1997), available at http://bioethics.georgetown.edu/nbac/pubs/cloning1/cloning.pdf.
153 See, e.g., Prohibition on Cloning of Human Beings Act of 1998, S. 1602, 105th Cong. (1998), available at http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=105_cong_ bills&docid=f:s1602is.txt.pdf.
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157 The President’s Council on Bioethics, supra note 92, at 27.
158 Harriet S. Raab, Federal Funding for Research Involving Human Pluripotent Stem Cells, Department of Health and Human Services, The General Counsel, Washington D.C. (Jan. 15, 1999).
159 Id.
160 The President’s Council on Bioethics, supra note 92, at 27.
161 Id. at 28.
162 Id.
163 President Discusses Stem Research, supra note 2.
164 Id.
165 The White House, Fact Sheet: Embryonic Stem Cell Research (Aug. 9, 2001), http://www.whitehouse.gov/news/releases/2001/08/20010809-1.html.
166 President Discusses Stem Cell Research, supra note 2.
167 Jerome Groopman, Holding Cell: Why the Cloning Decision was Wrong, New Republic, Aug. 5, 2002, at 14.
168 President Discusses Stem Cell Research, supra note 2.
169 Sheryl Gay Stolberg, Stem Cell Research is Slowed by Restrictions, Scientists Say, N.Y. Times, Sept. 26, 2002, at A27.
170 Id.
171 Press Release, Juvenile Diabetes Research Found., JDRF Statement on HHS Announcement of Stem Cell Bank, (July 14, 2004), available at http://www.jdrf.org/index.cfm ?page_id=101199.
172 Ann B. Parson, The Proteus Effect: Stem Cells and Their Promise for Medicine 244 (2004).
173 Juvenile Diabetes Research Found., supra note 171.
174 The President’s Council on Bioethics, supra note 92, at 35.
175 U.S. Department of Health and Human Services, National Institutes of Health, Estimates of Funding for Various Diseases, Conditions, Research Areas, March 10, 2006, http://www.nih.gov/news/fundingresearchareas.htm.2002. Figures from Conversation with Baldwin Wong, Chief, Science, Policy and Planning Branch, NIDCD, NIH, 8/11/2006. Non-embryonic includes adult stem cells as well as umbilical cord, fetal, placental stem cells as well as other, non-embryonic sources.
176 Human Cloning Prohibition Act of 2003, S. 245, 108th Cong. (2003), available at http://www.govtrack.us/congress/bill.xpd?bill=s108-245.
177 Stem Cell Research Enhancement Act of 2005, H.R. 810, 109th Cong. (2005), available at http://www.govtrack.us/congress/bill.xpd?bill=h109-810.
178 Id.
179 Sheryl Gay Stolberg, In Rare Threat, Bush Vows Veto of Stem Cell Bill, N.Y. Times, May 21, 2005, at A1.
180 Editorial, Stem Cell Showdown, Wash. Post, July 17, 2006, at A14.
181 E.g., CBS News, Poll: Stem Cell Use Gains Support (May 24, 2005), http://www.cbsnews.com/stories/2005/05/24/opinion/polls/main697546.shtml. According to this source, 58% of Americans approve of stem cell research while 31% do not. Id.
182 E.g., Terri Somers, $151.5 Million for Stem Cell Grants Approved; Board Sets Goals for State Studies, San Diego Union-Trib., Aug. 3, 2006, at C3.
183 Nat’l Conf. of State Legis., State Embryonic and Fetal Research Laws (2006), available at http://www.ncsl.org/programs/health/genetics/embfet.htm; Jodi Rudoren, Stem Cell Work Gets States’ Aid After Bush Veto, N.Y. Times, July 25, 2006, at A1; Editorial, The States Confront Stem Cells, N.Y. Times, Mar. 31, 2006, at A18.
184 Rudoren, supra note 183, at A1.
185 Id.
186 Id.
187 Carl T. Hall, Proposition 71: A New Era for Stem Cell Study, S.F. Chron., Nov. 4, 2004, at B1. For more on Proposition 71, See generally Connie Bruck, Hollywood Science, New Yorker, Oct. 18, 2004, at 62.
188 Hall, supra note 187, at B1.
189 Ceci Conolly, California to Enact Bill Promoting Stem Cell Research, Wash. Post, Sept. 22, 2002, at A12.
190 Paul Elias, Judge Says California Stem Cell Agency Legal, Associated Press, Apr. 22, 2006, http://www.stemcellbattles.com/SF%20Chron%204-22-06.htm; Carl T. Hall, California; Foes of Stem Cell Program Undaunted by Court Defeat, S.F. Chron., Dec. 1, 2005, at B2; Andrew Pollack, Trial Over California Stem Cell Research Ends, N.Y. Times, Mar. 3, 2006, at A19.
191 Elias, supra note 190.
192 Andrew Pollack, $14 Million for Research on Stem Cells, N.Y. Times, Apr. 5, 2006, at C12.
193 Ellen Florian Kratz, How Bush’s Stem Cell Veto Affects U.S. Science, Fortune, Aug. 7, 2006 at 16; Somers, supra note 182, at C-3.
194 Pollack, supra note 193, at C12; Rudoren, supra note 183, at A1.
195 Robert Kolker, The California Stem-Cell Gold Rush, N.Y. Mag., Jan. 3, 2005, at 35, 36, available at http://www.nymetro.com/nymetro/health/features/10755/index.html.
196 Id.
197 Id. at 38.
198 US States Making Stem Cell Policies, BioNews.org.uk, May 17, 2004, http://www.bionews.org.uk/new.lasso?storyid=2091.
199 Battelle Tech. P’ship Practice and SSTI, Growing the Nation’s Bioscience Sector: State Bioscience Initiatives 2006, Apr. 2006, at xix, available at http://www.bio.org/local/battelle2006/battelle2006.pdf [hereinafter Battelle Report]; State of New Jersey Comm’n on Sci. & Tech., Stem Cell Research in New Jersey (2006), available at http://www.state.nj.us/scitech/stemcell/.
200 Battelle Report, supra note 199, at xix; The States Confront Stem Cells, supra note 183, at A18.
201 Rudoren, supra note 183, at A1; The States Confront Stem Cells, supra note 183, at A18.
202 Statement of the Biotechnology Industry Organization, Submitted to the Subcommittee on Labor, Health and Human Services, Education of the Senate Appropriations Committee, Hearing Regarding Commercial Development of Pluripotent Stem Cells, (Jan. 12, 1999), available at http://www.bio.org/bioethics/background/stemcell_testimony.asp.
203 Stephen S. Hall, The Recycled Generation, N.Y. Times Mag., Jan. 30, 2000, at 30, 34; Kristen Philipkoski, Bioethics in the Hot Seat, Wired News, Jan. 18, 2001, http://www.wired.com/news/technology/0,1282,41244,00.html.
204 Matthew Herper & Robert Langreth, Anti-Ban Billionaires, Forbes, Sept. 4, 2006, at 124, 124-25; Holden, Constance, States, Foundations Lead the Way After Bush Vetoes Stem Cell Bill, 313 Science 420, 420-21 (2006).CrossRefGoogle ScholarPubMed
205 South Dakota is the only state to prohibit embryonic stem cell research. Arizona bans the use of state funds for both reproductive and therapeutic cloning; and Missouri and Maryland prohibit the use of state funds for reproductive cloning. Nat’l Conf. of State Legis., supra note 129.
206 John C. Fletcher, The Stem Cell Debate in Historical Context, in The Human Embryonic Stem Cell Debate 30 (Suzanne Holland et al. eds., 2001).
207 Scott Gottlieb, Adult Cells Do It Better, Am. Spectator, June 2001, at 16; Aaron Smith, Adult Stem Cell Biotechs: Better Prospects, Less Controversy, CNNMoney.com, Aug. 9, 2006, http://money.cnn.com/2006/08/09/news/companies/stemcells/.
208 Steve Mitchell, U.S. Stem Cell Policy Deters Investors, United Press Int’L, Nov. 2, 2002, http://www.upi.com/NewsTrack/Science/2002/11/02/us_stem_cell_policy_deters_inv estors/6291/.
209 Id.
210 Michael J. Lysaght & Anne L. Hazlehurst, Private Sector Development of Stem Cell Technology and Therapeutic Cloning, 9 Tissue Engineering 555, at 560-61 (2003).
211 Data compiled directly by author, from various data sources.
212 The States Confront Stem Cells, supra note 183, at A18 (“Privately financed research is an option, but the government makes that difficult at sites where other scientists work with federally financed equipment.”); See also Nicholas Wade, Some Scientists See Shift in Stem Cell Hopes, N.Y. Times, Aug. 14, 2006, at A18.
213 See The States Confront Stem Cells, supra note 183, at A18; Wade, supra note 212, at A18; See also Fletcher, supra note 206, at 30.
214 Wade, supra note 207, at A18.
215 Nicholas Wade, 2 New Efforts to Develop Stem Cell Line for Study, N.Y. Times, June 7, 2006, at A18.
216 Claudia Dreifus, At Harvard's Stem Cell Center, the Barriers Run Deep and Wide, N.Y. Times, Jan. 24, 2006, at F2; Sheryl Gay Stolberg, Senate Appears Poised for Showdown with President Over Stem Cell Research, N.Y. Times, July 16, 2006, at 18.
217 Gareth Cook, Stem Cell Center Set at Harvard; Researchers Seek to Bypass US Restrictions, Boston Globe, Feb. 29, 2004, at A1.
218 Irina Oberman, Stem Cell Debate Impacts Stanford, XXXVII STAN. REV. (2006), available at http://www.stanfordreview.org/Archive/Volume_XXXVII/Issue_1/News/news2. shtml; Carl Hall, $16 Million Gift for UCSF Research Center, S.F. Chron., May 12, 2006, at B6; Press Release, Columbia Univ. Med. Ctr., Columbia University Medical Center Launches Multi-Year Campaign to Support Stem Cell Research (June 15, 2005), available at http://www.cumc.columbia.edu/stemcell/initiative/press_release_stem_cell.html; See also Robert Lee Holz, Stem Cell Labs Take Private Path, L.A. Times, June 11, 2006, at A4.
219 David Kirkpatrick, Stem Cell Bill Sails Through House, but a Veto is Probable, N.Y. Times, Jan. 12, 2007, at A19; Somers, supra note 193, at C-3.
220 Owen-Smith, Jason & McCormick, Jennifer, An International Gap in Human ES Cell Research, 24 Nature Biotechnology 391, 392 (2006)CrossRefGoogle ScholarPubMed (warning that resistance toward an expansion of federal funding suggests a “real danger” for biomedicine).
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