Embryonic Stem Cell Research— in 1988, Only to Be Resumed Under a 1993 Executive Order Issued by Old Controversy; New Debate President Clinton

Issues & Implications fetus following an abortion, was halted by the Reagan administration Embryonic Stem Cell Research— in 1988, only to be resumed under a 1993 executive order issued by Old Controversy; New Debate President Clinton. Only months after Clinton’s action, Congress adopted By Rachel Benson Gold legislation codifying into federal law guidelines for such research that had been proposed by yet another spe- cial NIH review panel. Significantly, The debate over federal funding of been the subject of long-standing Congress was spurred to action by research involving fetuses and mate- controversy that has led to a com- sustained pressure by the research rial derived from fetuses has ranged plex web of policymaking—involving community and the support of key far and wide over the course of three administration officials, Congress senators with solid antiabortion decades. Its common thread, how- and a string of specially created records, including former Sens. ever, is an enduring controversy expert review panels (“Human Robert Dole (R-KS), a longtime advo- over work that is portrayed by its Embryo and Fetal Research: Medical cate for disability issues, and Strom proponents as holding immense sci- Support and Political Controversy,” Thurmond (R-SC), whose daughter entific promise and by its opponents TGR, February 2001, page 3). The suffers from diabetes. as devaluing human life in its most current state of federal policy setting basic form. forth when and under what circum- The latest chapter in this long saga stances such research may be con- involves embryonic stem cell The debate’s most recent incarna- ducted with federal funds is summa- research—research using cells tion centers on the use of stem cells rized in the chart on page 5. derived from days-old “spare” derived from embryos in the very embryos, which were created in the earliest stages of development; these Just as the promise of process of infertility treatment but cells have long been thought by sci- stem cell research predat- never implanted and slated to be dis- entists to have an extraordinary ed the reality, so did the carded. Even before embryonic stem potential for alleviating the suffering cells were first isolated in 1998, sci- caused by conditions ranging from political controversy and entists were eager to work with them diabetes to Alzheimer’s disease to the active involvement of because they have the potential to spinal cord injury. In a rare break antiabortion activists. generate the different kinds of tissue with its political base, the Bush a body may need. According to a administration in 2001 enunciated a In the 1970s, the controversy focused special committee established by the policy that would permit some on research involving fetuses in National Academy of Sciences research to go forward with federal utero, aimed at developing techniques (NAS), researchers hope that “har- funds, albeit with very stringent such as amniocentesis and improving nessing the capabilities of stem restrictions. Three years later, that the understanding of conditions such cells…could then help repair dam- compromise approach has garnered as congenital heart disease, as well as aged and diseased organs or provide little support, either among the sci- on research involving tissue from alternatives to organ transplants. entific community or the public at aborted fetuses of the type that led to Stem cell therapy could offer hope large. the polio vaccine. Federal funding of for the millions who suffer from this research was halted until guide- spinal-cord injuries, cardiovascular lines and safeguards were established disease, autoimmune disease, dia- Long-standing Debate by a blue-ribbon, congressionally betes, osteoporosis, cancer, Research involving human embryos mandated commission and later codi- Alzheimer’s disease, Parkinson’s dis- and fetuses has yielded an impres- fied into federal law. ease and other disorders.” sive array of results over the years. As far back as 1954, the Nobel Prize In the 1980s, the controversy shifted Just as the promise of stem cell for Medicine was awarded to scien- to research involving the transplan- research predated the reality, so did tists whose work on cultures of tation of fetal tissue into adults with the political controversy and the human fetal kidney cells led to the an array of serious conditions— active involvement of antiabortion development of the polio vaccine. including diabetes, Parkinson’s dis- activists. In 1995, Congress moved But balanced at the intersection of ease and spinal cord injuries. to prohibit the use of federal funds science, politics and personal ethics, Federal funding of this work, which to create human embryos solely for fetal and embryo research also has involves material derived from a research purposes or to destroy

The Guttmacher Report on Public Policy October 2004 4 arriving, NIH appointed a committee RESEARCH INVOLVING HUMAN EMBRYOS AND FETUSES to review the proposals.

DEFINITION USE STAT U S O F FEDERAL FUNDING A New Moratorium When the Bush administration took FETAL RESEARCH An umbrella term Used in the Allowed in accordance with 1975 encompassing the study development of regulations, as codified by 1985 office in January 2001, many of fetuses (in utero or ex vaccines and to law, which prohibit researchers expected it to move quickly to block utero) or the use of fetal study aspects of from having any involvement in cells and tissues general- cell physiology the decision to terminate a preg- NIH’s steps toward funding stem cell ly obtained from and human nancy or assessing fetal viability research, in line with what opponents induced abortions. development. and forbid altering the timing or intended with the passage of the 1995 method of abortion for the sake of research and the payment of any ban on using federal funds to destroy inducements that might encour- embryos. However, President Bush age a woman to have an abortion. instead directed DHHS Secretary Tommy G. Thompson to review the FETAL TISSUE Research involving Used to develop Allowed in accordance with 1993 TRANSPLANTATION transplantation of potential treat- law, which ensures informed con- issue. With the policy in limbo, NIH RESEARCH “multipotent” cells ments for a vari- sent, forbids the woman providing canceled the first scheduled meeting (“differentiated” cells ety of conditions, the tissue from being paid or of the review committee, which had that give rise to more such as diabetes knowing the identity of the recipi- specialized cells) and tis- and Parkinson’s ent, forbids altering the timing or been set for April. sues generally obtained disease. method of abortion for the sake of from aborted fetuses. research and attempts to avoid the commercialization of fetal tissue. Even while the president was delib- erating, support for stem cell IN VITRO Research on reproduc- Used to under- Effectively prohibited by 1995 law, research began building among FERTILIZATION tion in which sperm and stand and devel- which blocks funding for any antiabortion Republicans. That RESEARCH egg are combined in a op treatments for research in which human embryos laboratory dish, where infertility; IVF are destroyed, discarded or know- spring, long-standing abortion foes fertilization occurs. also used for ingly subjected to serious risk. Sens. Connie Mack (R-FL) and deriving stem cells (see below). Thurmond announced their support for the research. In June, Sen. Orrin STEM CELL The study of “undiffer- Used to under- In accordance with 2001 executive G. Hatch (R-UT), who had led the RESEARCH entiated,” or “pluripo- stand factors in order, federal funds may be used fight in Congress against fetal tissue tent,” stem cells, which abnormal human to support research only on are able to divide and development. embryonic stem cell lines created transplantation research, announced form into many differ- Considered poten- on or before August 9, 2001. his support for stem cell research. ent cell types. Stem cells tially useful in can be derived from treating genetic aborted fetuses, from disorders or organ The administration finally announced embryos created failure and, its policy in August 2001. In a state- through IVF for the sole through trans- ment delivered from his Texas ranch, purpose of research, plantation, from embryos created Parkinson’s dis- Bush attempted to walk a fine line through IVF but not ease, Alzheimer’s between those clamoring for funding implanted in women disease, spinal for stem cell research and those— being treated for infertil- cord injury, ity and through a stroke, burns, including many of the administra- cloning technique called heart disease and tion’s most steadfast allies—wanting somatic cell nuclear diabetes. a complete ban on the work. In craft- transfer. ing his policy, the president used the date of the speech as a major, albeit arbitrary, demarcation point, and them (which effectively prohibited In January 1999, the general counsel prohibited the use of federal funds for federally funded research into in determined that federal funds could research on stem cell lines created vitro fertilization). Because of the be used for research involving stem after that point. In an attempt to be extraordinary promise of the cell lines as long as the actual seen as not impeding science, Bush research, the National Institutes of derivation of those cells had been announced that funds could be used, Health (NIH) sought guidance from conducted with private funds. however, for work on the 64 cell lines the general counsel of its parent Armed with this opinion, NIH issued estimated by the administration to be agency, the Department of Health guidelines in August 2000 for in existence as of that point (“Bush and Human Services (DHHS), on the research involving the use of existing Okays Some Stem Cell Research exact applicability of that congres- cell lines and solicited research Funding; Debate Continues,” TGR, sional ban to stem cell research. applications. As applications began August 2001, page 12).

The Guttmacher Report on Public Policy October 2004 5 Reaction was swift. Interestingly, where it is likely to be controlled by ordeal, “I’m determined to do what- much of the strongest criticism came the private sector’s need for profit ever I can to save other families from opponents of the research, who rather than the goals of basic sci- from this pain,” Mrs. Reagan told had wanted no federal involvement ence. “NIH money is the engine for attendees at a dinner for the whatsoever. “President Bush,” said biomedical research in this country,” Juvenile Diabetes Research the press statement released by the Johns Hopkins researcher John Foundation. “I just don’t see how we American Life League the next Gearhart said in the Baltimore Sun. can turn our backs on this.” morning, “has stepped aside and “In this area, that engine is limited. Democratic presidential hopeful Sen. cleared the path for those who And that has a major, major impact.” John Kerry (D-MA), a long-standing demand unrestricted freedom to dis- stem cell research supporter, sect and discard the tiniest and most pledged to expand federal support A Developing Wedge vulnerable of our fellow human for the research days after Ron beings.” Proponents, meanwhile, Research supporters, concerned Reagan Jr. touted its enormous were more measured in their about the impediments posed by the promise in a prime-time address at response, applauding even the lim- Bush administration’s policy, have the Democratic National ited research possibilities the presi- mounted an aggressive campaign to Convention. dent’s policy afforded but question- allow NIH to assume its traditional ing whether enough research role by both providing research dol- The impact registered quickly. A material would be available. “While lars and setting critical ethical stan- Harris poll conducted in August we are pleased that the President dards for work involving embryonic found 73% of Americans saying they supports the research,” said the stem cells. Throughout, the cam- support the research, with support president of the Juvenile Diabetes paign seeks to emphasize the poten- outpolling opposition by a ratio of Research Foundation, “we are con- tial benefits of the work while giving six to one, including majority sup- cerned about the limitations he has the issue a human face, in the form port among Republicans. The pro- placed on it.” of policymakers’ constituents—or portion believing that the research even family members—whose suffer- should be banned because it is A bipartisan group of 206 ing might be alleviated or prognosis unethical and immoral fell from 32% improved. House members and 58 to 15% over the last three years. senators sent letters to This effort has borne fruit this year, All of this seems to have painted the the president urging him as what had been a somewhat administration into a corner, albeit to ease the restrictions on arcane biomedical research issue one of its own making. As the presi- has received unparalleled national, stem cell research. dential election nears, political pun- and political, prominence. This dits are speculating as to whether Even cautious optimism faded spring, a bipartisan group of 206 and what extent public opinion in quickly, however. Only a month House members and 58 senators support of the stem cell issue might after the president’s announcement, sent letters to the president urging actually be reflected at the polls. At a report released by the NAS con- him to ease the restrictions on stem the same time, speculation also is cluded that additional stem cell lines cell research. Notably, the bipartisan rising that no matter who is elected, would be necessary if the promise of group of signatories include such the issue may have reached a tipping the research were to be fulfilled. antiabortion stalwarts as Reps. Dana point—that even a second Bush And, indeed, just this year, the Rohrabacher (R-CA) and Charles W. administration would have difficulty Washington Post cited an unpub- Stenholm (D-TX) and Sens. Trent clinging to its increasingly unpopular lished NIH analysis concluding that Lott (R-MS) and Kay Bailey position. only 15 stem cell lines are available Hutchinson (R-TX). to federally funded researchers, a far Meanwhile, apparently unwilling to cry from the number that had origi- But the real sea-change came from wait for policy to be sorted out at nally been promised when the the events surrounding the death of the federal level, two states are step- administration’s policy had been former president Ronald Reagan ping into the breach. In a bid to announced in 2001. from Alzheimer’s disease, which establish the state as a center for thrust the issue directly into elec- cutting-edge research, New Jersey Moreover, the restrictions, according toral politics. While Nancy Reagan put $11.5 million for stem cell to the NAS, force stem cell research had been known to have supported research in its budget for the current into the private market, both here stem cell research privately, she fiscal year. And in California, voters and in other countries, beyond the spoke out publicly for the first time are being asked to approve a budget reach of federal ethical oversight and in May. As a result of her husband’s (Continued on page 14)

The Guttmacher Report on Public Policy October 2004 6 Courts Strike ‘Partial-Birth’… Embryonic Stem Cell Research… Continued from page 3 Continued from page 6

fertilization to read an almost 200- initiative in November to establish a word script to the pregnant woman similar state-funded research effort; stating that “the Congress of the the initiate would authorize the state United States has determined” that to issue $3 billion in bonds to her “unborn child” can feel pain and finance research over a 10-year that the abortion will cause it pain, period. The campaign in support of and that by law she has the option the California initiative has received of choosing to have anesthesia or critical financial backing from a wide other pain-reducing drugs adminis- array of supporters, including busi- tered directly to the “pain-capable nessman and philanthropist Bill unborn child.” The bill would Gates, Sen. Jon S. Corzine (D-NJ), require the pregnant woman to actor and Parkinson’s patient accept or reject the pain medication Michael J. Fox and George P. for the fetus in writing. Schultz, secretary of state in the Reagan administration. Because of Certainly, the issue of whether and at its potential to rejuvenate the state’s what point fetuses experience pain is lagging high-tech sector, it is also an important one that should inform supported by the California best medical practice and is currently Chamber of Commerce. the subject of active discussion within the medical community. Given the This article was supported in part by a grant from the David and Lucile Packard uncertainty, proponents of the legisla- Foundation. The conclusions and opinions tion once again aim to dictate med- expressed in this article, however, are those ical practice from the position of ide- of the author and The Alan Guttmacher Institute. ology, rather than science. Whether they will heed the admonishments of the three judges in this latest round of “partial-birth” abortion cases, and conduct balanced fact finding before acting, remains to be seen.

PRSRT First Class U.S. Postage PAID Binghamton, NY PERMIT No. 588 ON PUBLIC POLICY October 2004

120 Wall Street, 21st floor New York, NY 10005

ADDRESS SERVICE REQUESTED