Stem Cells: Ethics, Law and Politics

678

20 Biotechnology Law Report 678Number 5 (October 2001)Mary Ann Liebert, Inc.

Stem Cells: Ethics, Law and Politics

ALEXANDER MORGAN CAPRON*

Over the past three years, human stem cells havemoved from being something of esoteric inter-

est for basic researchers and of therapeutic value forclinicians to being a highly visible source of distressin the relationship between right-to-life advocatesand their traditional political allies. In recentdecades, countless biomedical developments havebecome entangled in—and disrupted or even de-railed by—the fallout from abortion-related politi-cal debates. For a while, human stem cell researchseemed to be headed for the same fate. But for oncethe reverse appears to be true, for in this case, sci-ence has disrupted politics rather than the other wayaround: during the spring and summer of 2001,some prominent Republican right-to-life loyalistspublicly urged federal funding of research with hu-man embryonic stem cells, even as others warnedPresident George W. Bush that such funding wouldmake him complicit in “an industry of death.”1 Fi-nally, on August 9, in his first televised address tothe nation since becoming President, Mr. Bush an-nounced a compromise that allowed him to keep tothe letter of a campaign pledge not to finance thedestruction of live embryos while also providingsome opportunity for federally funded researchersto use human embryonic stem cells.2 It is too soonto know whether the compromise will work in sci-entific terms, much less whether it will provide theresults that the President sought politically, but theimportance of the field now seems firmly estab-lished in the mind of the public. This article exam-ines the scientific aspects of the field and how thescience came to be entangled with politics (with alook at the policy options that were before the Pres-ident and that remain before Congress), the ethicaldebate (which is almost certainly not been resolved

by the President’s decision), and the resulting legalproblems (which have their own complexities).

Stem cells have only recently entered public con-sciousness but—media commentaries notwithstand-ing—they are nothing new to scientists and physi-cians. Stem cells have long been understood (as theirname implies) as the foundation of organisms, thestalk from which everything buds and branches. Indevelopmental terms, the first cells of a new or-ganism are totipotent, that is, each one has the abil-ity to develop into an entire organism—indeed,when the cells of a two-celled zygote separate, iden-tical twins are produced.

After several days of cell division, the next de-velopmental step is these cells to begin differentia-tion. Some will form the trophoblast and placentallayers that will support the growing fetus; these cellsform into the outside of the blastocyst, a hollowsphere, like a tiny beach ball, that will become at-tached and take sustenance from the lining of theuterus. The remaining stem cells—those clumpedtogether inside the blastocyst, which are known asthe inner cell mass—become the basis for the fetusitself. The latter cells are pluripotent; this means thatthey no longer possess a totipotent cell’s ability tobecome an entire organism but they are able to de-velop into the more than 200 cell types present in amature organism. In the words of Caltech biologyprofessor David Anderson, “They are infant cellsthat have not yet chosen a profession.”3 Under stim-

*University Professor of Law and Medicine, University ofSouthern California.

1David Boyer, Stem cell research divides the GOP; Centrists,leaders try to sway Bush, WASHINGTON TIMES, July 4, 2001, atA6 (quoting letter to President Bush from Reps. Dick Armey[House majority leader], Tom DeLay [House majority whip],and J.C. Watts, Jr. [House Republican Conference chairman]).2 Frank Bruni, Bush Gives His Backing for Limited Researchon Existing Stem Cells, N.Y. TIMES, Aug. 10, 2001, at A1, col. 1.3 David J. Anderson, The Alchemy of Stem Cell Research, N.Y.TIMES, July 15, 2001, Sec.4, p. 15.

Biotechnology Law Report � Volume 20, Number 5 679

uli that are not yet fully understood, these cells dif-ferentiate in an unfolding process which, when itoperates according to plan, produces a viable,healthy organism made up of many distinct types ofcells. For example, some of the pluripotent stemcells become neural stem cells, which then producethe variety of cells that make up the neurologicalsystem. As Professor Anderson puts it, the tissue-specific stem cells “even though not yet adult, arelike young professionals already embarked on a ca-reer: they still have options, but fewer of them.”4

Until recently, this process has been thought of asunidirectional, with each pluripotent cell establish-ing a line of daughter cells destined to a particular“fate” (as bone, blood, muscle, skin, and the like),like the members of a family in feudal society, des-tined to do the work of smiths or bakers generationafter generation.

Among the differentiated cells that make up ma-ture organisms are some stem cells associated witheach particular tissue or organ—skin stem cells,blood stem cells, and so forth. These cells are im-portant for continuous tissue homeostasis (e.g., main-taining the skin and blood) and for the normal repairprocesses of adult organisms. Physicians have longexploited this regenerative capacity, for example, inusing bone marrow transplants (which contain stro-mal cells and hematopoietic stem cells) to repopulatethe cells in the blood and immune system followingirradiation of patients with neoplastic disease.5

Stems cells became matters of intense scientificand public interest when, in November 1998, re-searchers at the University of Wisconsin announcedsuccess in deriving and culturing human embryonicstem cells, just as Johns Hopkins University scien-tists published their success with embryonic germcells. The cell lines established by these researchgroups from the inner cell mass of days-old blasto-cysts and from the gonadal ridge of five-to-nineweek-old aborted fetuses, respectively, are bothpluripotent (having the capacity to give rise to alltypes of cells) and stably self-replicating (perpetu-ating themselves indefinitely in culture without ei-ther mutating or progressing into different cellfates). The creation of these cell lines represents asubstantial step towards generating a renewablesource of stem cells for research, and, in the future,for clinical treatment. Without lines of culturedpluripotent cells, prospects for research and therapyusing stem cells are severely hampered by havingrepeatedly to harvest stem cells from embryos. Yet

the public’s great interest in these cells has notarisen solely because scientists have proclaimedthem research tools of unparalleled value and thebasis for the emerging field of “regenerative medi-cine.” What has made embryonic stem cells mattersof intense interest is that to derive them scientistsmust destroy early-stage embryos or harvest tissuefrom aborted fetuses, two processes that stir up in-tense opposition in certain quarters.

I. STEM CELLS AND POLITICS

Based on the clash between moral objections todestroying potential human life and biomedical re-searchers’ interest in human stem cells’ possiblevalue as tools in embryological and pharmacologi-cal research and clinicians’ hopes for their thera-peutic potential, particularly in organ and tissuetransplantation, research with these cells has movedto the front page of the paper and the top of theevening news, as scientists, politicians, lawyers, theologians, and members of the general public6

debate how—and even whether—they should be de-rived and used.

The political battle over stem cell research has re-ceived a tremendous amount of news coverage.7 Theissue before the President was whether to reject ormodify rules adopted in 2000 by NIH, but sus-pended by HHS Secretary Tommy Thompson inApril 2001, under which federal funds could bespent on research using stem cells derived from hu-man embryos and aborted fetuses by private labo-ratories which followed specified ethical safe-guards. Whereas President Bush’s usual “CEOstyle” of delegation would mean that such a deci-sion would be left to Secretary Thompson, it wastaken into the White House. Spokesmen kept thepublic informed about how deeply the President was

4 Id.5 Eugene H. Kaji & Jeffrey M. Leiden, Gene and Stem CellTherapies, 285 JAMA 545, 545–550 (2001).6 See Stem Cell Research Compromise Misguided, LOS ANGE-LES TIMES, July 10, 2001, at Part 2 Page 10. See also Letters toThe Editor, SAN FRANCISCO CHRONICLE, July 10, 2001, at A16(“Doesn’t the decision about stem cell research come down tothis: Are adults with debilitating or lethal diseases, like Parkin-son’s or Alzheimer’s, as human as a fertilized egg?”).7 A LexisNexis™ search produced 548 news articles discussingstem cells during the single week of July 7–13, 2001; duringthe seven days following the President’s speech (August 10–16,2001), the tide of articles swelled to 1137 and has only slowlyabated.

680 Biotechnology Law Report � Volume 20, Number 5

immersed in the issue and how preoccupied he hadbecome with it.8 In the weeks before the decision,commentators (with the usual hyperbole) describedthe decision as one “that could define his presi-dency”9 and as a “lose-lose situation that would con-found King Solomon.”10 And once the decision hadbeen made, reporters emphasized how the stagingof the announcement aimed “to portray Mr. Bush asprofoundly ruminative, deeply serious and indis-putably presidential.”11

While the President’s decision seems to haveachieved his political objectives, the issue is not onethat he would likely have chosen to play a definingrole in the first year of his presidency.** But the con-voluted politics of stem cell research virtually guar-anteed it would become a high profile issue. Whilepolls showed that a majority of Americans, includ-

ing Catholics, supported federal funding of embry-onic stem cell research,12 hard-line opponents ofabortion argued that the President would pay a po-litical price if he permitted the Department of Healthand Human Services to fund such research.13 Wellinto the spring, President Bush was sticking to theanti-embryonic stem cell position he took during thepresidential campaign. As recently as May 18, 2001,the President reiterated that position to the Cultureof Life Foundation, a pro-life group: “I oppose Fed-eral funding for stem-cell research that involves de-stroying living human embryos.”14

Matters were made worse by a slew of letterswritten to the President—and then publicly re-leased—by various factions within the Republicanparty, including prominent pro-life legislators, thatpulled President Bush in opposite directions.15 The

8 “Bush is famous for his quick executive decisions and ab-horrence of long briefings or memos.

But as he confronts the most politically sensitive decisionof his presidency thus far, Bush is agonizing to an unusual degree.

* * *With little fanfare, Bush is consulting widely. He is soak-

ing up information, opinions and advice—and, above all, tak-ing his time trying to forge a compromise.”

Edwin Chen & Aaron Zitner, Bush Deep Into Cell Study, LOS

ANGELES TIMES, July 13, 2001, at A7. See also Ceci Connolly,President ‘Agonizing’ on Embryo Question, WASHINGTON POST,July 15, at A1.9 See William Safire, Stem Cell Hard Sell, NEW YORK TIMES,July 5, 2001 at A17.10 Elaine S. Povich, Middle of the Road; Bush faces a lose-losesituation with stem cell research, NEWSDAY (New York, NY),July 10, 2001, at A7 (Quoting conservative Hudson Instituteanalyst Marshall Wittmann, “It’s a lose-lose situation. This isa decision that would confound King Solomon.”); See alsoMimi Hall, Stem-cell issue splits Republicans Both sides lobbyBush in debate, USA TODAY, July 6, 2001, at A6 (Presidentbombarded by opponents and supporters from within his ownparty on whether to fund an activity that one side calls murderand the other side hails as life-saving).11 Frank Bruni, note 2 supra.**[Editor’s note: obviously the tragic events of September 11,2001, completely changed all previous efforts to characterizethe first year of George W. Bush’s presidency.]12 See Elaine S. Povich, Middle of the Road; Bush faces a lose-lose situation with stem cell research, NEWSDAY (New York,NY), July 10, 2001, at A7 (ABC News/Beliefnet poll, June20–24 [margin of error 1/2 3%] showed 60 percent of re-spondents supported “funding for stem cell research.”); FredRosen, Stem-cell research of vast benefit, THE BALTIMORE SUN

July 9, 2001, at 9A (Jan. 2001 poll commissioned by the Ju-venile Diabetes Research Foundation revealed that more thantwice as many Americans [65%] support federal funding ofstem-cell research than oppose it [26%]); Evan Thomas et al,Battle for Bush’s Soul, NEWSWEEK July 9, 2001, at 28 (Ac-cording to a new Wall Street Journal/NBC News poll, 72% of

white Catholics favor stem-cell research); Representative J.C.Watts and John Podesta discuss stem cell research and othertopics before the Bush White House, Meet the Press (NBC),July 8, 2001 (Citing a Wall Street Journal-NBC News poll asshowing “overwhelming public support”: 69% in favor, 23%opposed); CNN-USA Today-Gallup poll, July 10–11, “Do youthink the federal government should or should not fund this typeof research, or don’t you know enough to say?” Should, 30%;Should not, 13%; Don’t know enough, 57%. “Which comesclosest to your view of this kind of stem cell research?” Morallywrong and is unnecessary, 20%; Morally wrong, may be nec-essary, 34%; Not morally wrong, may be necessary, 35%; Notmorally wrong but is unnecessary, 4%; No opinion, 7%. Asso-ciated Press, Stem Cells Polls at a Glance, July 12, 2001.13 Evan Thomas et al., Battle for Bush’s Soul, NEWSWEEK, July 9,2001, at 28. (Roman Catholic Church hierarchy has vigorously op-posed the procedure as a violation of the sanctity of life, and aturging of Karl Rove, the President’s top political advisor, Presi-dent Bush has been avidly and visibly courting Catholics).14 Robert Pear, G.O.P. Leaders in the House Fight Stem-CallAid, N.Y. TIMES, July 3, 2001, at A1.15 See Ramesh Ponnuru, Cells, Fetuses, and Logic: Who is be-ing sentimental, who rational, in this debate?, NATIONAL RE-VIEW, July 23, 2001, at LIII. (Quoting Sen. Orrin Hatch (R-UT):“I just cannot equate a child living in the womb, with movingtoes and fingers and a beating heart, with an embryo in afreezer.”); Evan Thomas et al., Battle for Bush’s Soul,NEWSWEEK July 9, 2001, at 28 (Rep. Jennifer Dunn (R-WA)sent Bush a letter, signed by 30 House Republicans, urging himto allow stem cell research; Sen. Trent Lott (R-MI, the SenateMinority Leader) has hinted his support for research; Sen. JohnMcCain (R-AZ) has reversed his campaign stand against it);Stem-cell Research must Proceed, THE SEATTLE TIMES July 8,2001, at B6 (Republican Main Street Partnership, an allianceof 60 GOP House and Senate members, sent a letter to the WhiteHouse expressing support for research using human embryonicstem cells); Centrists, leaders try to sway Bush, WASHINGTON

TIMES, July 04, 2001, at A6 (quoting letter to President Bushfrom Reps. Dick Armey [House majority leader], Tom DeLay[House majority whip], and J.C. Watts, Jr. [House RepublicanConference chairman] declaring that supporters of the researchwere agents of “an industry of death.”).


public division over stem cell research within theRepublican party upset the President,16 though someof the pressure also generated “cover” for any de-cision. For example, the “discrete” (yet still dis-closed) lobbying in favor of embryonic stem cell re-search by Nancy Reagan and other aides to theex-President, who suffers from Alzheimer’s disease,left some right-to-life advocates more sympatheticto the decision.17

As part of a process of looking for allies and test-ing the waters, various compromise positions werefloated, though many commentators doubted thatany compromise would succeed in placating oppo-nents, all of whom seemed to have strongly heldmoral convictions.18 But compromise can some-

times do the political trick. The Clinton administra-tion’s position on human embryonic stem cell re-search, which was also a compromise, might be la-beled hypocritical but it survived intense lobbyingfrom both sides; likewise, the position of legislatorswho insist they are “pro-life” in supporting the de-struction of human embryos in the service of de-veloping means of saving patients’ lives seemed in-consistent to some but apparently was accepted bymost of the public.19 While topics like this—wherethe tugs on the opposite ends of the ideological ropeare very strong—often seem to leave policymakerstied up in knots, a deft slice may sometimes cut theknot. It is too soon to say whether that will provetrue of the President’s August 9th decision.20

16 Letter By Armey, DeLay and Watts On Stem-Cell Issue In-furiates White House, THE BULLETIN’S FRONTRUNNER, July 9,2001 (White House officials were furious after House GOPleaders issued a statement warning President George W. Bushnot to lift a ban on federal funding for research using stem cellsderived from human embryos; meanwhile, other House Re-publicans, even some who oppose federal funding for stem-cellresearch, castigated Reps. Armey, DeLay, and Watts for the let-ter: “I think you want to be very careful with the tone unlessyou want to say that Connie Mack and Orrin Hatch are shillsfor the industry of death,” said Rep. Peter King [R-NY], refer-ring to two staunchly pro-life Republicans who have urged Bushto back stem-cell research funding.”). After the draft of a re-port being prepared by NIH scientists at the direction of HHSSecretary Thompson—which points to a ‘dazzling array’ oftreatment possibilities and concludes that ‘all avenues of re-search should be exhaustively investigated, including both adultand embryonic sources of tissue’—was leaked to the press, itemerged that the White House was unaware not only that thereport was about to be published, but that it was being re-searched at all. Ed Vulliamy, Focus: Medicine and ethics: Thecell struggle: Stem cell research is President Bush’s new bat-tleground. It could save lives and make money—but it pits managainst God and divides Republicans, THE OBSERVER, July 8,2001, at 18.17 Frank Bruni, From Nancy Reagan, a Nod Toward EmbryonicStem Cell Research, N.Y. TIMES, July 13, 2001, at A14—andthe President mentioned her views in his speech. Conversely,the decision to hold back on embryonic cell work was mademore reasonable in light of the President having heard adviceon the evening of July 10 from two prominent bioethicists to“go slow” on embryonic stem cell research which has been“oversold,” especially since one of them, Daniel Callahan afounder of the Hastings Center, is described as “a Democrat whodid not vote for Bush.” Ceci Connolly, President ‘Agonizing’on Embryo Question, WASHINGTON POST, July 15, 2001, at A1.18 Leaders in the anti-abortion movement say they expect thePresident to abide by his campaign promises that federal fundswill “not underwrite research that involves the destruction oflive human embryos.” Robin Toner, Conservatives PressureBush in Cell Debate, N.Y. TIMES, July 12, 2001, at A1. (KenConnor, president of the conservative Family Research Coun-cil: “There should be a nonnegotiable principle that says inno-

cent human life is sacrosanct and on this we will not compro-mise”; Richard Doerflinger, of the United States Conference ofCatholic Bishops: “It has no convincing stopping point onceyou begin funding some of this research. And I think it givesup the moral argument at its core.”); Evan Thomas et al., Bat-tle for Bush’s Soul, NEWSWEEK July 9, 2001, at 28 (Dr. DavidStevens [executive director of the Christian Medical Associa-tion] comparing stem-cell research to using the results of Nazimedical experiments: “This is really a life-and-death issue. . . .It’s hard to compromise on that kind of thing.”). Moreover,most scientists are equally unhappy—though for practical ratherthan moral reasons—with the proposed compromise. LarrySoler [chair of the Coalition for the Advancement of MedicalResearch]: “[the compromise is] seriously inadequate. Limitingresearch to a few existing cell lines . . . would not allow enoughdiversity to treat people with widely varying immunologies”).Id. See also Rick Weiss, For President, No Easy Solution toStem Cell Debate, WASHINGTON POST, July 13, 2001, atA1(Richard Doerflinger: “Any of these so-called compromisesare going to greatly displease people with moral principles andalso displease the scientists who want to hold to their scientificprinciples.”).19 “The (asterisked) pro-lifers who favor the research have tounderstand that in principle what they support on behalf of thosethey love is pretty much what they oppose for those they don’tcare about. For what ails them—an affliction as old asmankind—no cure is in sight. It’s called hypocrisy” RichardCohen, Pro-Life With an Asterisk, THE WASHINGTON POST, July10, 2001 at A21.20 Columnist Frank Rich gave the President a backhand salutefor his “act of self-serving political Houdinism”:

Denigrated as a lightweight and a slacker, he seized on thestem cell debate to transform his image into that of ourphilosopher king—grappling mightily with the science andethics of an issue he and his handlers hyped as “one of themost profound of our time—even as he induced religious-right leaders to sell out their principles and sent Alzheimer’s,Parkinson’s and juvenile diabetes patients to the back of themedical research bus.

Frank Rich, The Genius of George W. Bush, N.Y. Times, Au-gust 18, 2001, B-15.

II. HOW STEM CELLS FIT INTOFEDERAL FUNDING RULES

A. Three Sources of Pluripotent Stem Cells

The problems now faced by politicians, the pub-lic, and scientists themselves began in one week inNovember 1998 when three research announce-ments in rapid succession greatly elevated the im-portance of human embryonic stem cells in both sci-entific and policy terms. The November 6 issue ofthe journal Science carried a report from the labo-ratory of James A. Thomson at the University ofWisconsin describing the derivation of pluripotentstem cells from human embryos.21 These cells,called human embryonic stem cells (hESCs), wereisolated by culturing cleavage-stage human embryosin vitro to the blastocyst stage and then isolating theinner cell mass (ICM) which normally develops intothe fetus during embryogenesis. The embryos fromwhich the researchers derived the cell lines wereoriginally created in fertility clinics through in vitrofertilization (IVF) and subsequently donated to re-search. The researchers were able to keep the EScell lines in a pluripotent state by treating them witha cocktail of growth factors, including mouse“feeder” cells from embryos and bovine serum.Analysis of these cultures revealed that the cells ex-pressed proteins characteristic of stem cells in otherspecies. Furthermore, the cells could be stimulatedto form tissue derivatives of all three embryonicgerm layers, which indicates that they are pluripo-tent. Thomson’s method of deriving hESCs by ex-tracting the ICM necessarily destroys the blastocystand thus the developing organism.

By contrast, the method described by JohnGearhart and his colleagues from Johns HopkinsUniversity in the Proceedings of the National Acad-emy of Sciences on November 10 utilizes fetusesthat have died in the process of abortion.22 Thepluripotent cell lines established by Gearhart’sgroup are referred to as human embryonic germ cells(hEGCs) because the are generated from primordialgerm cells extracted from the gonadal ridge of fiveto nine week-old abortuses. The isolated cells arecalled germ cells because their ultimate develop-mental fate in the organism is to form the eggs orsperm. These cells derived from the gonadal ridgeapparently behave very much like the stem cells de-rived from the ICM though not identically.

The third and most controversial derivation of

embryonic stem cell lines, reported in the New YorkTimes on November 12, 1998, but never publishedin a peer-reviewed journal, described researchers ata private company having obtained stem cells froman embryo that had been created clonally.23 A re-searcher had inserted the nucleus of his own somaticcell into an enucleated cow egg to form a hybridembryo from which ICM cells were derived, in aprocess analogous to that used by Thomson’s labo-ratory. In culture, the cells expressed markers andbehaved similarly to pluripotent stem cells. On July12, 2001, the Washington Post revealed that the pri-vate biotechnology company which had performedthis experiment—Advanced Cell Technology (ACT)of Worcester, Massachusetts—had, after “more thana year of quiet and careful preparation” with humanrather than cow eggs, “started a series of experi-ments aimed at creating cloned human embryos orembryo-like entities from which embryonic stemcells could be derived.”24 Their method is doublycontroversial, because it involves both the creationof human embryos solely for the purpose of de-stroying them during research and generating theembryos through somatic cell nuclear transfer(SCNT)—the method used to create Dolly, the firstcloned mammal, in 1996. (While a number ofgroups have recently announced their intention totry cloning a human being, the only previously re-ported attempt to use SCNT to create a human em-bryo reportedly occurred in 1999 in Korea; thosescientists told reporters that they destroyed thecloned embryo at a very early stage but have neverpublished a report of their research in a peer-re-viewed journal.)

B. How Certain Research Came to be Ineligible

For more than twenty-five years, the federal gov-ernment has placed restrictions on the use of re-search funds for studies in which fetuses or embryoscould be harmed. These restrictions, apply to allDHHS grants and contracts, originated in Subpart


21 J.A. Thomson et al., Embryonic Stem Cell Lines Derived fromHuman Blastocysts, 282 SCIENCE 1145, 1145–1147 (1998).22 M.J. Shamblott et al., Derivation of Pluripotent Stem Cellsfrom Cultured Human Primordial Germ Cells, 95 PROCEEDING

NAT’L ACAD. SCI. 13726, 13726–13731 (1998).23 Nicholas Wade, Researchers Claim Embryonic Cell Mix ofHuman and Cow, N.Y. TIMES, Nov. 12, 1998, at A1.24 Rick Weiss, Mass. Firm Aims to Clone Embryos for StemCells, WASHINGTON POST, July 12, 2001 at A1.


B of 45 CFR 46, which covers research on “1) thefetus, 2) pregnant women, and 3) human in vitro fer-tilization.” These rules have implications first forfederal support of research involving hEGCs de-rived from aborted fetuses and second for researchinvolving hESCs derived from IVF embryos.25

By the mid-1980s, initial research had suggestedthat tissue taken from the brains of aborted fetusesmight offer a means of treating Parkinson’s andother neurological diseases. When a protocol doesnot expose a living fetus to risk but involves onlytissues from a dead fetus, Subpart B requires onlythat the research be conducted in accordance withapplicable state or local laws; nonetheless, NIH Di-rector James Wyngaarden decided that the “scien-tific and ethical implications” of fetal tissue trans-plantation were so great that he ought to obtainapproval from Assistant Secretary of Health RobertE. Windom before allowing NIH physicians orgrantees to proceed.26 In March 1988, Dr. Windomdeclared a moratorium on federal support for fetaltissue transplantation research and asked NIH to es-tablish an advisory panel. In the fall, the panel (bya margin of 19-2) recommended continued fundingfor this research, under guidelines designed to en-sure its ethical integrity.27 After the transition fromthe Reagan to the Bush administrations, DHHS Sec-retary Louis Sullivan extended the moratorium, onthe basis of the concerns expressed by the minoritymembers of the panel that the proposed protectionswere insufficient to ensure either that women wouldnot be induced to become pregnant or have abor-tions in order to make donations or that the womenfreely consented to use of the fetal tissue. Congres-sional attempts to override this decision were notenacted or were vetoed by President Bush.

On January 22, 1993, in one of his first officialacts, President Clinton instructed the incomingDHHS Secretary to lift the moratorium.28 In March1993, NIH published guidelines based on the 1988advisory panel’s safeguards as limits on permissi-ble research, and Congress promptly incorporatedthem into the NIH Revitalization Act of 1993.29

Specifically, these rules seek not only to ensure fulldisclosure of information and voluntary consent ofdonors but also to remove any incentives for womento conceive fetuses or to abort them, such as for-bidding researchers to pay for fetal tissues or topromise that donated tissue will be transplanted intoa particular person. While Dr. Gearhart’s work ac-tually adhered to the federal rules,30 he chose to

steer clear of any potential problems by not usingpublic funds in deriving hEGCs from the gonadalridge cells of aborted fetuses; indeed, the conclud-ing stages of his research were supported by theGeron Corporation of Menlo Park, California.

Other restrictions in federal law made the workdone by Dr. Thomson’s group ineligible for federalfunding, however, and he went to great lengths toseparate that work, which was also supported byGeron,31 from his other research at the University,which did have federal support. Prof. Thomson’s re-search falls under a ban on funding embryo researchcontained in a rider—the Dickey Amendment—thatCongress first attached to the funds appropriated forthe Department of Health and Human Services(DHHS) in 1996.32 Yet the effective prohibition onsuch research goes back to the late 1970s and thedebates about research to create “test tube babies.”In 1977, a university investigator applied for fed-eral funds for research involving laboratory-created

25 45 C.F.R. §46.201(a)(2000).26 Kenneth J. Ryan, Tissue Transplantation from Aborted Fe-tuses, Organ Transplantation from Anencephalic Infants, andKeeping Brain-Dead Pregnant Women Alive Until Fetal Via-bility, 65 SO. CAL. L. REV. 683, 697 (1991).27 K.F. Duguay, Fetal Tissue Transplantation: Ethical and Le-gal Considerations, 1 CIRCLES: BUFFALO WOMEN’S JOURNAL

OF LAW AND SOCIAL POLICY 36 (1992).28 See 58 Fed. Reg. 7457 (1993).29 By deleting the requirement in the DHHS regulations on hu-man subjects research that IVF research undergo review by anEthics Advisory Board appointed by the Secretary, 45 C.F.R.§§46.203(g) and 46.204(d), the Act ended the de facto bar onfunding of such research. Pub. L. No. 103–43, June 10, 1993.30 Since the Act applies only to fetal tissue obtained for trans-plantation, Dr. Gearhart’s work

arguably is not covered . . . because [the hEGCs in his re-search] were intended to be cultured and used in laboratoryexperiments, not transplanted. Nevertheless, if such researchwere federally supported, it could be subject to the require-ments of Subpart B of 45 C.F.R. 46—both the general lim-itations of §46.206 (separating the investigators from theabortion process and forbidding payments for pregnancy ter-mination) and the special requirements of §46.210 for activ-ities involving cells and tissues from dead fetuses.

National Bioethics Advisory Commission, ETHICAL ISSUES IN

HUMAN STEM CELL RESEARCH 31 (Vol. 1, Sept. 1999).31 Anne McLaren, Cloning: Pathways to a Pluripotent Future,SCIENCE, June 9, 2000, at 1775. Geron has received licensingagreements for the hESC and hEGC lines developed by Thom-son’s and Gearhart’s groups (respectively).32 The rider preempted a decision, announced by NIH DirectorHarold Varmus, to fund research involving “surplus” IVF em-bryos from fertility centers. Pub. L. No. 104–99, Title I, § 128, 110 Stat. 26, 34 (1996).


embryos and the following year, stimulated by thegreat media attention to IVF arising from the birthin England of Louise Brown, the Secretary of theDepartment of Health, Education and Welfare(DHEW) charged the Ethics Advisory Board (EAB)with studying the social, legal and ethical issuesraised by IVF. On May 4, 1979, the EAB reportedto the Secretary it had concluded that federal sup-port for IVF research was ethically acceptable un-der certain conditions.33 Specifically, the board rec-ommended that federally funded research shouldoccur only until the time at which the embryoswould normally be implanted (14 days after fertil-ization) and that research involving human IVFwithout embryo transfer be designed primarily to es-tablish the safety and efficacy of embryo transferand to obtain important scientific information to-ward that end not reasonably attainable by othermeans.34 Furthermore, the board recommended thatthe human gametes used in IVF research must beobtained from persons who have been fully in-formed of the nature of the research and freely con-sented to the use of their gametes in the research.

Neither the Secretary at the time nor any of hersuccessors have ever acted either to accept or rejectthe EAB’s recommendations, and no experimentsinvolving human embryos have been funded pur-suant to the conditions set forth in the report.35

Shortly thereafter, the EAB was dissolved, makingconsideration of further proposals to fund researchinvolving embryos impossible.36 The requirementfor EAB review was removed by §121(c) of the1993 NIH Revitalization Act, which should haveended the prohibition on federal funding of researchon human embryos.37 Indeed in 1994, NIH Direc-tor Harold Varmus appointed a Human Embryo Re-search Panel to establish guidelines for federallyfunded embryo research. The panel made severalrecommendations including allowing the use in re-search of embryos left over from IVF provided theywere donated to research with the informed consentof the progenitors; the panel also concluded (withdissents) that under certain circumstances investi-gators should be allowed to create human embryosusing IVF with the intent to use them solely in re-search.38 However, on the day these recommenda-tions were unanimously accepted by the AdvisoryCouncil to the Director of NIH, President Clintondirected that no federal funds were to be used to cre-ate human embryos for research.39 In order to en-sure this directive was not modified, Congress

adopted the Dickey Amendment to the Fiscal Year1996 DHHS appropriation and has included a com-parable provision in every subsequent appropria-tions bill prohibiting federal funding for research inwhich human embryos are created for research pur-poses through any means, including IVF andcloning, or are destroyed, discarded, or knowinglysubjected to risk of injury or death greater than thatallowed by Federal regulations for research on fe-tuses in utero (which is essentially zero risk not jus-tified by a benefit to that fetus). It is clear from thephrasing of the rider that the method used by Thom-son to derive human stem cells could not be feder-ally funded; likewise, for research of the type car-ried out by ACT using cloned embryos. The ban onfederal funding does not, of course, prohibit the ac-tivity itself; other than laws in a few states that at-tempt to restrict or outlaw human embryo research(which have been successfully challenged for bur-dening the reproductive rights of infertile coupleswho claim such research might benefit them40), both

33 Ronald M. Green, Stopping Embryo Research, 9 HEALTH MA-TRIX 235, 238 (1999).34 Ethics Advisory Board, Department of Health, Education,and Welfare, REPORT AND CONCLUSIONS: HEW SUPPORT OF RE-SEARCH INVOLVING HUMAN IN VITRO FERTILIZATIO N AND EM-BRYO TRANSFER (May 4, 1979).35 One result of the effective moratorium on federal support hasbeen the removal to private fertility clinics of most research in-volving human IVF, which is essentially supported by patient-care dollars; unlike other cutting-edge fields of medicine, re-search in fertility has not taken place within the context of theNIH Clinical Center or federally funded units at academichealth centers and hence has lacked the visibility, ethical over-sight, and careful research design that characterizes most of ex-perimental medicine in the United States.36 Ronald M. Green, Stopping Embryo Research, 9 HEALTH MA-TRIX 235, 238 (1999).37 NIH Revitalization Act of 1993, Pub. L. No. 103–43,§121(c), 107 Stat. 122, 133 (1993) (nullifying 45 C.F.R.45.204(d) as it pertains to the EAB).38 Ronald M. Green, Stopping Embryo Research, 9 HEALTH MA-TRIX 235, 238 (1999).39 Id.40 See generally Lifchez V. Hartigan, 735 F. Supp. 1361 (per-manently enjoining the enforcement of Ill.Rev.Stat., Ch. 38 para.81–26, § 6(7) (1989), which barred fetal experimentation, as un-constitutionally vague because classification of a particular pro-cedure as either “experimental” or “routine” could easily be out-of-date within six months given rapid development ofreproductive endocrinology, leaving physicians unsure whethercertain procedures are illegal, and because statute impermissi-bly intruded on a “cluster of constitutionally protected choices,”which include medical procedures that may bring about, ratherthan prevent, pregnancy). See also Forbes v. Napolitano, 247F.3d 903, 904 (9th Cir. 2000) (A.R.S. §§ 36–2302, subpart (A),which criminalized any “medical experimentation or investiga-tion involving fetal tissue,” held void for vagueness).


the creation of embryos and their use to createcolonies of pluripotent stem cells is largely unreg-ulated. Twenty-four states and the District of Co-lumbia do not restrict research on fetuses or em-bryos, and the restrictions in most of the remainingjurisdictions are aimed principally at fetal researchand only 10 prohibit or restrict embryological re-search.41

III. THE POTENTIAL CONTRIBUTIONS OFSTEM CELL RESEARCH

If federal law has imposed barriers to the pursuitof human embryonic stem cell research—at least ona par with other areas of comparable biomedical im-portance—policymakers want to know: what’s atstake? What are the potential contributions of thisfield, both to basic science and to medical treatment?

A. Basic Research

It seems to be widely agreed in scientific circlesthat hESC research will be invaluable to basic sci-ence. First, the availability of these cells greatly enhances the experimental tools to study the biol-ogy of normal human development and the devel-opmental problems that lead to diseases and dis-abilities. Second, hESC research will increaseunderstanding of the specific process of cellular dif-ferentiation and tissue specification.

Research on early human development is cur-rently relatively difficult because of the restrictionsinvolved in working with live human beings. Currentresearch is limited to experiments that are not harm-ful to the fetus as well as those involving the em-bryology of other species. The knowledge derivedfrom such studies could be greatly enhanced by ex-perimentation on hESC lines. For example, mouseembryology is often used as a model for early mam-malian development and mouse ES cell lines are acharacterized part of mouse embryology. Compar-isons between human and mouse ES cell lines mayprovide powerful insights into early human develop-ment. Furthermore, a better understanding of humandevelopment may lead to insight into the interplaybetween development and the cell cycle, which is im-portant in understanding how a normal cell becomesa cancer cell. Finally, a better understanding of hu-man development will help illuminate the processesbehind developmental defects, and in turn, may leadto new therapies to combat these defects.

A specific area of basic research that will benefitfrom hESC research is the understanding of cellulardifferentiation.42 A significant part of understandingdevelopment is identifying the signals that lead tocertain cell fates, especially since this choice of fatesis rarely as simple as a cell receiving a single signal.For example, in forming a limb, cells receive multi-ple signals organized in spatially defined patternsand gradients.43 The position of the cell within thispattern then determines its ultimate cell fate. ES celllines are an important tool in the very difficult andcomplex process of properly characterizing the sig-nals required to adopt specific cell fates.

Currently, most of the information about differ-entiation cues comes from work performed in otherorganisms and then analogized to humans. Once asignal is identified in another organism, it may bepossible to identify and clone a human homolog tothat gene, though this does not assure that the hu-man gene performs the same function. Unless theresearcher is especially fortunate and the gene hap-pens to be identified with a genetically defined trait,further research will be needed to determine whetherthe gene performs the same function in humans asin the organism where it was first identified. Shortof human experimentation, the options for estab-lishing gene function include biochemical studies ofthe gene product and in vivo assays using transgenicanimals. These methods all suffer from the caveatthat the experiments are not being performed withinthe proper context, so that crucial elements may bemissing and thus result in misleading and erroneousfindings.

One method to try and get around these problemsis to test the role of the gene in the context of a hu-man cell line. Unfortunately, most cell lines consistof differentiated cells which have become “immor-tal” as a result of chromosomal or genetic changesthat allow them to divide indefinitely. Though suchcell lines have been partially changed in order to

41 C.L. Feiler, Human Embryo Experimentation: Regulationand Relative Rights, 66 FORDHAM L. REV. 2435 (1998). “Allten states that prohibit embryological research have vaguelyworded statutes which could encompass cell line developmentif the statutes were interpreted broadly.” J. Coleman, PlayingGod or Playing Scientist: A Constitutional Analysis of StateLaws Banning Embryological Procedures, 27 PACIFIC L.J.1331,1358 (1996).42 K. Sue O’Shea, Embryonic Stem Cell Models of Develop-ment, 257 ANAT. REC. (NEW ANAT.) 32, 32–41 (1999).43 Randy L. Johnson & Cliff Tabin, 90 CELL 979, 979–990(1997).


make them useful for scientific inquiry and are nolonger identical to the specialized cells from whichthey are derived, they are sometimes useful to as-say the function of a new gene.

Although adult cell lines can be useful, pluripo-tent stem cell lines are a far superior context inwhich to perform experiments studying cellular spe-cialization because this is the type of cell that actu-ally differentiates within the human body, becausethey are already able to divide indefinitely, withoutthe need to be mutated to become immortal, and be-cause they posses a normal diploid karyotype, indi-cating that they are genetically analogous to the stemcells from which they were derived. Once the propersignaling cues are identified, the specialized cellsderived from hESC lines can be used to identify newgenes involved in cell fate specification. For exam-ple, researchers will be able to use the differentiatedcells to identify tissue-specific genes that are acti-vated in response to the signal to differentiate. Ul-timately, hESC lines could provide an unlimitedsource of tissue-specific material for biochemicalexperiments.

Obviously, the contribution of hESC research tobasic science has a secondary effect on clinical research. For example, cell differentiation and de-velopment must be understood if stem cells—including adult stem cells—are to provide a sourceof specialized tissue for transplantation. Absentsome means of directly obtaining neural stem cellsfor transplantation, for instance, a clinician mustfirst differentiate the hESCs into neural stem cells,or transdifferentiate a non-neuronal stem cell into aneural stem cell; this requires knowledge of theproper cell signals and how to use them. If such re-search is left to the private sector, it will probablyonly be pursued if it is likely to culminate in a vi-able product; the basic steps required to understanda rare neural degenerative disease might be ignoredbecause the cost of investigation far outweighs anypotential monetary benefit from developing a ther-apy. Thus, leaving the choice of what basic researchis performed to private groups will almost certainlyresult in an uneven patchwork of basic research thatcovers some developmental steps in great detail andleaves others relatively obscure.

B. Clinical Applications

The potential application of hESC research thathas received the greatest attention is transplantationof cells and tissue created in the lab. This applica-

tion of stem cell research—the regeneration of a dis-eased or defective organ—is easy for the averageperson to understand and obviously of significantbenefit. If successful, transplantation from hESCsources could overcome several major problems thatnow plague this field, namely the inadequate num-ber of donated organs and the inability to treat cer-tain conditions (such as spinal cord injuries) bytransplantation of donor organs. Pluripotent stemcell lines could provide a plentiful supply of trans-plantable cells and could be used to regenerate dam-aged heart and neural tissue.

An indication of the clinical potential can be seenin research in rats, which has shown that precursorsof specialized neural cells derived from ES cells canmyelinate axons of the brain and muscle44 The re-searchers differentiated ES cells in culture usingcombinations of growth factors known to stimulatedifferentiation of the cell population into oligoden-drocytes and astrocytes. They then transplantedthese cells into myelin-deficient rats which consti-tute an animal model for Pelizaeus-Merzbacher disease (PMD) a hereditary myelin disorder. Thetransplanted cells spread in six of nine rats and suc-cessfully myelinated axons. These results indicatethat the technique of differentiating ES cells to spe-cific cell types and using those cells to repair dam-aged tissue is viable. Similarly successful experi-ments have been carried out in mice whose myelindeficiency causes them to shiver45 and in rats withmechanically created spinal injuries.46 While suchexperiments strongly suggest that stem cell trans-plantation may eventually prove useful in treatingneural tissue damage, the experimental transplantsdid not completely restore neural function butmerely improved the performance of transplantedanimals versus untreated animals.

The potential of ES cell research is not limited toneural tissues. Stem cell transplantation has a broadvariety of potential applications. For example, stemcells could be used to treat Type I (insulin-depen-

44 O. Brustle et al, Embryonic Stem Cell-Derived Glial Pre-cursors: A Source of Myelinating Transplants, 285 SCIENCE

754, 754–756 (1999).45 B.D. Yandava et al., “Global” cell replacement is feasiblevia neural stem cell transplantation: Evidence from dysmyeli-nated shiverer mouse brain, 96 PROCEEDING NAT’L ACAD. SCI.7029, 7029–34 (1999).46 John W. McDonald et al., Transplanted embryonic stem cellssurvive, differentiate and promote recovery in injured rat spinalcord, 5 NATURE MEDICINE 1410, 1410–12 (1999).


dent) diabetes,47 to repair cardiac damage after aheart attack, or to treat victims of stroke, burns andarthritis. The potential of hESCs lies in their abilityto form a wide variety of tissues. Ideally, such cellswould function as a reservoir from which the ap-propriate cells for treatment could be collected. Ifthis technique is perfected, it would ultimately af-fect virtually all modern medicine.

Despite this potential, several caveats must be keptin mind. First, to perfect ES cell transplantation, re-searchers need to overcome the problem of host re-jection of transplanted tissues. One way to overcomethis problem is to maintain large libraries of stemcells with different major histocompatibility (MHC)alleles. The cell line used for transplantation couldbe selected based on recipient compatibility. A re-lated possibility would be to manipulate the antigenicmarkers on hESC lines to make them evade or co-exist with the recipient’s immune system.

A second way to get around the problem of hostrejection is to use adult stem cells derived from theperson needing the transplant. For example, currentbone marrow transplantation techniques involve re-moving a sample of bone marrow from the patient,isolating in vitro hematopoietic stem cells within themarrow sample, irradiating the patients remainingbone marrow and finally transplanting back into thepatient the bone marrow stem cells. The use of cul-tured stem cells to generate hematopoietic cellscould make this procedure even more robust be-cause the hematopoietic stem cells that are now ex-tracted from bone marrow do not grow well in cul-ture. Comparable results have already been achievedin irradiated mice by inducing skeletal muscle stemcells to produce hematopoietic stem cells.48

A third way around rejection would be to useSCNT from the patient to create an embryo fromwhich hESCs could be derived, which is an objec-tive that ACT has identified for its current attemptsto clone human embryos. The difficulties that nowexist in generating viable mammals through cloningand the developmental problems that many of thesurviving clones manifest suggest that, ethical andprudential issues aside,49 success in this line oftransplantation lies many years in the future. Fur-thermore, the generation of cells identical to the pa-tient’s would not be a useful treatment for condi-tions that occur because of a gene defect.

Another area in which hESC research may be ben-eficial is in drug discovery and drug safety testing. Anumber of cell lines are currently used this way, but

the potential to generate any cell line at will frompluiripotent stem cells would greatly facilitate specifictesting of drug and tissue interactions as well as al-low research into areas that were previously infeasi-ble due to the lack of appropriate cell lines.

IV. ETHICAL OBJECTIONS TO STEM CELL RESEARCH

Opponents of hESC research raise two main ob-jections: that the destruction of human embryosamounts to the taking of a human life, and that cre-ation of human embryos for research renders themobjects of utility rather than of inherent value. Nei-ther of these objections apply to adult stem cell re-search, which is why it proceeds and will likely con-tinue without ethical objection.

A. Objections to Destroying Embryos

The objection to the destruction of embryos is es-sentially the same as the “right-to-life” objection toabortion, namely that life begins at conception andhence killing an embryo is equivalent to the killingof any other human being. For example, during arecent Senate Labor-HHS Appropriations Subcom-mittee hearing, Senator Brownback (R-KS) analo-gized hESC research to the experiments conductedon Nazi camp inmates to underline his view that theinherent value of the embryo outweighed any util-ity that might be gained from ES cell research.50

While some right-to-life advocates object tohEGC research as well,51 many argue that deriving

47 Vijayakumar K. Ramiya et al., Reversal of insulin-dependentdiabetes using islets generated in vitro from pancreatic stemcells, 6 NATURE MEDICINE 278, 278–82 (2000).48 Kathyjo A. Jackson et al., Hematopoietic potential of stemcells isolated from murine skeletal muscle, 96 PROCEEDING

NAT’L ACAD. SCI. 14482, 14482–86 (1999).49 See Alexander M. Capron, Statement, Hearing on H.R. 1644and H.R. 2124 before the Subcomm. on Crime, House Judi-ciary Committee, 107th Cong., 1st Sess., June 19, 2001.50 Labor HHS Appropriations Subcommittee hearing on April26, 2000.51 President George W. Bush has frequently stated his own op-position to the use of tissue from aborted fetuses in researchgenerally. For example, shortly after assuming office in Janu-ary, the President said federal money should not be used be-cause he does “not support research from aborted fetuses.”Alissa J. Rubin & Aaron Zitner, Bush Opposes Use of AbortedTissue; Science: Reviving the Abortion Debate for the SecondTime This Week, the President didn’t say Whether he’d FightFederal Funding for Promising, Yet Problematic, Medical Re-search, L.A. TIMES, Jan. 27, 2001, at A6.


stem cells from embryos is more objectionable thanfrom fetal tissue because the scientist in the formercase is involved in the act that destroys the living be-ing. A scientist isolating fetal tissue, such as EG cells,works with an already aborted, dead fetus, whereashESC researchers end an embryo’s viability by re-moving stem cells from its ICM. While “discarded”embryos from fertility clinics would otherwise die,the time and method of destruction is determined bythe needs of the hESC researcher. By analogy, hESCopponents argue this act is no more moral than itwould be to harvest organs from an individual, suchas a condemned prisoner, because he will die soon.

The response of scientists to these criticisms hasbeen limited. Proponents of ES cell research havetried hard to make clear that ES cell lines themselvesare not equivalent to embryos, so that research withthe cells, as opposed to their derivation, is not prob-lematic.52 (In fact, NIH leaders and many other sci-entists refer to these cells only as “pluripotent stemcells” to avoid the word “embryo.”) Beyond this,scientists favoring hESC research have tended to ar-gue that a blastocyst in a laboratory cannot be com-pared with a person after birth, or even with a liv-ing fetus in the uterus, especially post-viability, andthat the enormous scientific potential of stem cellresearch justifies the destruction of embryos, espe-cially those that are being discarded anyway.53

Recently, some pro-life legislators have spoken upin favor of funding embryonic stem cell research. Forexample, at the beginning of July 2001, Sen. Orrin G.Hatch (R-Utah) disclosed that he had urged the BushAdministration to allow such funding because “Themost pro-life position would be to help people whosuffer from these maladies . . . That is far more ethi-cal than just abandoning or discarding these embry-onic stem cells.”54 Yet Hatch’s position is not simplyutilitarian (that the good for these many existing pa-tients justifies the loss of a few potential lives in re-search). Instead, Hatch squared research funding withhis pro-life views on the ground that an embryo in aPetri dish has no capacity to develop into a person inthe laboratory. That capacity is attained only after anembryo is transferred to a woman’s womb, and Hatchconcluded that the government’s interest in protectingthe embryo only arises at that point. His position re-sembles the view that ensoulment occurs not at con-ception but sometime later, variously put at 40 daysor at quickening. This view goes back to Aristotle andcontinued to be held by the Catholic Church until 1869when Pope Pius IX reasserted a position first adopted

in the Sixteenth Century forbidding abortion at anystage of pregnancy. More recent philosophers havedistinguished between the embryo as a “possible” per-son when in a petri dish, and as a “potential” person(and hence deserving of protection) once it has beentransferred to a uterus where it can develop on itsown.55 The Catholic hierarchy and many other reli-gious conservatives reject this attempt to resurrect“delayed ensoulment” (at least for IVF embryos), andsome secular critics have tagged the pro-life/pro-em-bryonic-stem-cell-research legislators hypocrites.56

B. Objections to Commodifying Embryos

The second objection commonly associated withstem cell research is that it encourages the com-modification of human life. This objection has twofacets. The broader version objects to any use of hu-man embryos as a research tool. Since such use nec-

52 In a recent New York Times op-ed article, Princeton molec-ular biologist Lee M. Silver probably did not endear himself tothe scientists trying to make such a sharp distinction when heextrapolated to human beings research first performed eightyears ago by embryologist Janet Rossant in which mouse EScells, wrapped in an artificial placental layer and implanted ina mouse uterus, developed into mice:

Because of their versatility, ES cells are the darlings of bio-medical research. All scientists need to do is to identify themolecular signals and cellular environment required to gen-erate any tissue or organ of choice. But if lab-grown ES cellscan be coaxed to develop into any one tissue, might there bean environment in which they could be coaxed into makinga whole human body? The answer is yes.

Acknowledging that “with the political debate at fever pitch”other scientists will challenge his interpretation, Prof. Silver ar-gued that for biologists, “words like ‘destruction,’ ‘creation,’‘embryo’ and even ‘life’ and ‘death’ are ambiguous.” Lee M.Silver, Just Whom Are You Calling an Embryo?, NY TIMES,Aug. 19, 2001, at B4, col. 1.53 See, e.g., David Baltimore, Stem Cell Research: A Debate—Don’t Impede Medical Progress, WALL STREET JOURNAL, July30, 2001, at A18.54 Ceci Connolly, Conservative Pressure for Stem Cell FundsBuilds; Key Antiabortionists Join Push for Embryo Research,THE WASHINGTON POST, July 02, 2001, at A01 (other conserv-ative supporters of funding hESC research include Sens. StromThurmond [R-SC] and Gordon Smith [R-OR] and former Sen.Connie Mack [R-FL], a Roman Catholic and a cancer survivorwho claims to hold firm to the view that life begins at concep-tion, though his thinking has evolved to take into account newscientific discoveries such as test tube fertilization).55 See Rick Weiss, Changing Conceptions, WASHINGTON POST,July 15, 2001, at B1 (quoting philosopher Carol Tauer of theMinnesota Center for Health Care Ethics).56 See, e.g., Richard Cohen, Pro-Life With an Asterisk, WASH-INGTON POST, July 10, 2001, at A21.


essarily occurs without the embryos’ consent andnot for their benefit, it treats them differently thanany other living human entity in research, insteadrendering them things, commodities to be used. Thesecond version of this objection is directed at thecreation of embryos solely for research, as was re-cently announced by one leading fertility center.57

Plainly, creating embryos solely for the purpose ofextracting stem cells runs afoul of the first com-modification argument as well. But it creates a sep-arate concern—even for persons who do not objectto the use of embryos that have been discarded andthat would disintegrate if not used in research—thatallowing the creation of embryos for research re-duces embryos to objects that possess only instru-mental and not inherent worth, and that it may leadto their commercialization, that is, the uncontrolledproduction and marketing of “human research em-bryos.”58

Unlike the objection that stem cell research iswrong because it rests on the killing of a humanbeing, both the broad and the narrow versions ofthe commodification objection do not depend fortheir force on assigning human embryos the samemoral status as persons, though they do presupposethat embryos deserve greater respect and concernthan other bunches of human cells that have no po-tential to become a person. It is sufficient to con-clude, as the National Bioethics Advisory Com-mission did in its 1999 report on stem cell researchand as many ethics panels have since the 1970s(such as the 1979 report of the DHEW Ethics Ad-visory Board, described previously, and the 1984Warnock Committee report in the U.K., discussedbelow), that “the embryo merits respect as a formof human life, but not the same level of respect ac-corded persons.”59

Several consequences could follow from thisview. First, the use of embryos should be restrictedto research offering a prospect of preventing or re-lieving human suffering in a way not otherwise rea-sonably attainable. This position draws on RonaldDworkin’s argument that many who object to abor-tion make an exception for rape or incest; since themoral status of a fetus arising from such wrongfulacts does not differ from that of a fetus conceivedwithout rape or incest, the willingness to allow abor-tion in such cases reflects a judgment that the pro-tection usually accorded to unborn human lifeshould yield before others’ very strong interests.60

Second, in order to avoid the slippery slope down

in which the human body would be treated like mer-chandise, and more broadly, human beings wouldbe objectified, commerce in embryos should be for-bidden.61

V. FEDERAL FUNDING OPTIONS:ALIGNING POLICY WITH

LAW AND ETHICS

Even if stem cell research delivers fewer or lessfar-reaching benefits than its sometimes feveredproponents now predict, this field will certainly pro-duce much of value both to basic biological knowl-edge and to medical treatment. Not surprisingly,cries are not heard to halt funding of research usingstem cells from laboratory animals or human stemcells from tissues other than embryos and fetuses.Furthermore, notwithstanding the ethical objectionsthat still emanate from some quarters regarding fed-eral support for research involving the extraction ofhEGCs from dead fetuses, the acceptability of suchresearch under existing law means that the focus ofthe debate in ethical as well as policy terms is onhESC research and whether any aspect of it shouldbe eligible for federal funding.

Four policy options have been advocated for fed-eral support of hESC research: no funding, fundingonly of research using the hESCs that have alreadybeen produced, funding of research using hESCs butnot their derivation from embryos, and funding ofresearch to derive as well as to use hESCs from em-

57 Susan E. Lanzendorf et al., Use of Human Gametes Obtainedfrom Anonymous Donors for the Production of Human Embry-onic Stem Cell Lines, 76 FERTILITY & STERILITY 132 (2001).See also Aaron Zitner, Embryos Created for Stem Cell Re-search, LOS ANGELES TIMES, July 11, 2001, at A1 (research crit-icized as scientifically unnecessary, ethically questionable, andpolitically inflammatory).58 Persons concerned about commerce in embryos also pointout that the creation of research embryos would largely rely onpurchased eggs and sperm, accelerating market forces that al-ready are at work in the context of assisted reproduction. Ulti-mately, the situation in which human precursors are for salecontributes to regarding human beings in themselves (particu-larly children) as objects of commerce.59 National Bioethics Advisory Commission, ETHICAL ISSUES IN

HUMAN STEM CELL RESEARCH 50 (Vol. 1, Sept. 1999).60See Ronald Dworkin, LIFE’S DOMINION: AN ARGUMENT

ABOUT ABORTION, EUTHANASIA, AND INDIVIDUAL FREEDOM

(1994).61 Were a market of buying and selling made-for-use humanembryos to emerge, it would almost certainly classify embryosby genotype and other measures of utility.


bryos. A further issue complicating each of the lat-ter three options is whether restrictions should beplaced on the source of the embryos involved—dis-carded, donated IVF embryos from fertility clinicsversus embryos created through IVF for researchpurposes versus embryos created (presumably forresearch purposes) through SCNT.

A. No Federal Support for Human EmbryonicStem Cell Research

Those who argue against federal support forhESC research advance two reasons why such sup-port is unnecessary and ought not to be providedgiven that a large portion (albeit not a majority) ofthe population believes such research is morally il-licit and would be offended with the use of theirtaxes to support it. First, they argue that nothing willbe lost because research can go forward with non-federal funding.62 Second they claim that the sameresearch results can be obtained by supporting re-search that uses differentiated (adult) human stemcells and hEGCs.

1. Leave the Field to Private Funding: Thefirst argument has a certain plausibility, given oursociety’s general predilection to leave matters to“the private sector” when possible. Yet given thepotential importance of this field of research such asanguine view of the effective ban on federal fund-ing hardly seems justifiable. Not only would re-searchers at such premier federal institutions as theNational Institutes of Health be prohibited fromworking with hESCs but all investigators in othersettings—including academic health centers andmedical schools, where a majority of the most im-portant research is federally supported—would haveto contort their work to ensure that any which in-volves hESCs (which could at any point becomequite a large proportion) is conducted separatelyfrom their federally supported work, in terms notonly of laboratory space and supplies and the workhours of themselves and all employees charged totheir federal grants and contracts but also the basicinfrastructure of the laboratory that receives “indi-rect” support under federal grants and contracts.

Moreover, to the extent that university re-searchers turn to private rather than federal funds,their work may fall under restrictions that for-profitcompanies often place on the use and disseminationof intellectual property whose creation they have

supported. Indeed, researchers obtaining hESCsfrom Wi-Cell (the not-for-profit subsidiary of theWisconsin Alumni Research Foundation that is mar-keting Prof. Thomson’s cell lines) must agree to re-strictions and licensing requirements imposed by theGeron Corp., which funded Thomson’s work andholds patents and other intellectual property rightsfor most of the significant stem cell and SCNT tech-niques.

A further effect of leaving hESC research to bedeveloped with private rather than governmentalsupport is that the choice of scientific areas—bothbasic and applied—to pursue will, of necessity, beguided by private companies’ estimate of the prof-its likely to be made rather than by the decisionsthat scientists proposing so-called R0-1 projectswould choose on their own. Finally, if the federalgovernment leaves the field to private industry, thelikelihood of strong, consistent, and transparent eth-ical standards and review of the processes by whichstem cells are derived and used will be underminedby differences among companies and among stateregulatory standards (which are mostly nonexistent)and by trade secrecy policies.63

2. Adult Stem Cells as an AlternativeMeans: The second argument against supportinghESC research—that other lines of research willyield the same result using means that do not gen-erate the same controversy—remains the principaldefense of conservatives responding to disease-ad-vocacy groups and others in biomedicine who viewstem cell research as the key to important thera-

62 See, e.g., Robert Oldham, Stem Cells: Private Sector Can DoIt Better, WALL STREET JOURNAL, Aug. 28, 2001, at A14, col.6 (drawing analogy to the boost that the private company Cel-era gave to the previously publicly funded effort to map the hu-man genome).63 “Federal funding guarantees that the broadest array of cogentscientific questions are asked in a public arena and subject tofederal oversight and ethical standards. This, in turn, will resultin the greatest benefit as opportunities will be pursued for theirscientific potential not their expected commercial value.”

Laura Lyman Rodriguez, Why Adult Stem Cell Research isNot Sufficient?, FASEB Office of Public Affairs (Aug. 14,2000) [http://fasb.org]. See also Andrea Knox, Bioethicist’sResignation in Pennsylvania Sparks Debate About Ethics,Cloning, PHILADELPHIA INQUIRER, July 17, 2001, at (universitybioethicist resigned in protest from ACT’s advisory body whenwhat he hoped would be a “a ringside seat to exciting researchthat needed ethical evaluation” proved to be merely “an ethicsstamp of approval” which the company was free to use or ignore).


peutic advances. There is no question that researchwith stem cells from laboratory animals will play anessential role in developing both basic knowledgeand new therapies in this as in every biomedicalfield, but as is always the case, eventually re-searchers must use human materials (and even hu-man subjects) especially in order to develop thetools of regenerative medicine which potentially in-volve inserting stem-cell-derived cells and tissuesinto patients. Opponents of hESC research arguethat this human material can come from adult stemcells that are being found in an increasing numberof bodily tissues and that have proven in recent yearsto be more malleable than scientists had previouslythought.

Indeed, recent findings have overthrown the olderview that adult stem cells are terminally tissue-spe-cific and that the process of differentiation of stemcells is linear and irreversible. In the past severalyears, for example, bone marrow-derived cells havebeen shown to give rise to muscle, liver, heart, andbrain cells, central nervous system stems cells canproduce blood cells, and cells from the dermal layerof the human scalp were coaxed to become nerve,muscle and fat cells.64

The discovery that stem cells in adults can firstreside in one tissue and then contribute to an-other suggests a previously unrecognized de-gree of plasticity in stem cell function. Indeed,it now appears that cell fate changes are a nat-ural property of stem cells and may be in-volved in ongoing physiological repair of tis-sue damage throughout life. [R]ather thanreferring to a discrete cellular entity, a stemcell most accurately refers to a biological func-tion that can be induced in many distinct typesof cells, even differentiated cells.65

For adult stem cells to play the role envisionedfor hESCs, scientists need to perfect methods toinduce the adult stem cells to dedifferentiate ortransdifferentiate.66 In the process of dedifferenti-ation, a tissue-specific stem cell—say a neuralstem cell—exposed to molecular signals would becaused to travel in reverse down the developmen-tal path that led it to become a neural cell in thefirst place. If the process worked, the cell wouldrevert to a less specialized state, perhaps all theway back to pluripotency. (Once pluripotent, thecell could be used for basic research or caused to

differentiate into a desired type.) In transdifferen-tiation, a stem cell of one tissue type is exposed tosignals that provoke a change of characteristics tothose of another stem cell type. Essentially thestem cell reaches its destination without going backto the starting gate.

Despite the promise of this research, it is too soonto assume that adult stem cells are equivalent in po-tential to hESCs. First, the fact that adult stem cellshave some of the characteristics of pluripotent stemcells does not mean that they will be identical. Onlyby studying both embryonic and adult stem cells cana proper assessment be made of the potential of thelatter in transplant therapies or in other branches ofresearch. Second, it now appears that research us-ing hESCs—which are naturally responsive to a va-riety of differentiating stimuli—will be needed toidentify the chemical triggers for transdifferentia-tion and dedifferentiation in adult stem cells.67 In-deed, adult stem cells are not likely to provide thesame information about development and differen-tiation that will come out of hESC research regard-ing problems as diverse as developmental disordersand cancer.

Moreover, unanticipated problems may arise inapplying either ES cells or adult stem cells to actualmedical therapies and it is impossible to know be-fore which will be successful in any particular cir-cumstance. Thus, adult stem cell research should notbe viewed as a substitute for hESC research but asa complementary area of scientific inquiry. As a re-cent NIH report concludes, “it is impossible to pre-dict which stem cells—those derived from the em-bryo, the fetus, or the adult—or which methods formanipulating the cells, will best meet the needs ofbasic research and clinical applications.”68 By vig-

64 Jean G. Toma, Mahnaz Akhavan, Karl J. L. Fernandes, FanieBarnabé-Heider, Abbas Sadikot, David R. Kaplan and Freda D.Miller, Isolation of multipotent adult stem cells from the der-mis of mammalian skin, 3 NATURE CELL BIOLOGY 778–784(Sept. 2001).65 H.M. Blau et al., The Evolving Concept of a Stem Cell: En-tity or Function?, 105 CELL 829 (2001).66 See Irving L. Weissman, Stem Cells: Units of Development,Units of Regeneration and Units in Evolution, 100 CELL 160,160–62 (2000).67 Stephen Jay Gould, What Only the Embryo Knows, N.Y.TIMES, Aug. 27, 2001, at A21, col. 1.68 Ceci Connolly, Embryo Cells’ Promise Cited in NIH Study;Call for More Research Toughens Bush Choice, WASHINGTON

POST, July 18, 2001, at A1.


orously pursuing research with cells from embry-onic as well as adult sources, proponents of hESCresearch argue that scientists will greatly increasethe likelihood that the benefits—especially newtherapies—of this new field will be realized. If theeventual ability to manipulate adult stem cellsproves to be as great as its boosters now predict,adult stem cells can replace embryonic ones as re-search and therapeutic tools.69 In the meanwhile,betting on only one horse (and one with some ob-vious handicaps in the race) will almost certainlydelay—and may even prevent—achieving resultsthat are important to science and perhaps vital to thelives of some patients.70

B. Federal Support Only for Using PrivatelyDerived Cells

In increasing degree of liberality, the next two ofthe four policy options would be federal fundingonly for research using the hESCs that have alreadybeen produced, and federal funding for research us-ing all appropriately derived hESCs but not for thederivation of hESCs from embryos. But the order inwhich these are best considered is the reverse be-cause the second option—which was first floated asa compromise by White House insiders in July2001—is a modification of the third option, whichwas the compromise struck by the Clinton Admin-istration.

1. Funding Use But Not Derivation: The NIHprocedures that were suspended by SecretaryThompson in April 2001 represented a compromisedesigned by the Clinton Administration to allowfederal support for stem cell research without vio-lating the Dickey Amendment. As relevant here, thatappropriations rider essentially forbids funds goingtoward the creation or destruction of human em-bryos.71 In response to a request that NIH DirectorVarmus made once the potential of human stem cellresearch became apparent in the winter of 1998,HHS General Counsel Harriet Rabb issued an opin-ion memorandum on January 15, 1999, in which sheconcluded that since stem cells are pluripotent(rather than totipotent) they are not in themselvesembryos so that research with them is eligible forfederal funding.72 In shorthand, federal funds couldgo for “use” but not for “derivation,” since the lat-

ter (but not the former) involves destruction of em-bryos.

To prepare standards for grants, NIH appointed apanel of experts who designed a system to ensurethat although federally supported researchers werelimited to embryonic stem cells derived by privateparties, those parties would adhere to appropriateethical strictures in the manner in which they de-rived the cells. In December 1999, NIH released adraft of guidelines for funding research involvinghuman pluripotent stem cells.73 After an extendedperiod of debate the final NIH guidelines were re-leased on August 25, 2000.74 The guidelines retainthe distinction between use and derivation and adda requirement that the stem cell lines be derived

69 Much of the same reasoning applies to research with hEGCsas an alternative to hESC research. While research of the for-mer type is definitely worth pursuing, at this point, not enoughis known about the differences between hEGCs and hESCs tojustify funding only germ cell research. It would be prematureto assume that the two types of cell lines are essentially iden-tical and not pursue research on both.70 As one commentator rather rhetorically pointed out recently:

Even if . . . adult stem cells turn out to be almost as goodas embryonic ones, which many politicians are hoping willspare them a tough decision, that “almost” will lead to un-necessary suffering and death if adult cells become an ex-cuse to restrict embryonic ones. So, if that’s what you thinkjustice for embryos requires, you had better be sure you’reright.

Michael Kinsley, If You Believe Embryos Are Humans . . . thencurbing research on stem cells is an odd place to start pro-tecting them, TIME, June 25, 2001, at 80.71 Pub. L. No. 105–277, § 511 (1998).72 Harriet Rabb, Memorandum to Harold Varmus M.D., Di-rector, NIH, Federal Funding for Research Involving HumanPluripotent Stem Cells, January 15, 1999.73 National Institutes of Health Draft Guidelines for ResearchUsing Human Pluripotent Stem Cells, 64 Fed. Reg. 67576. (De-cember 2, 1999). NIH responded to the complaint that thesewere guidelines rather than regulations, by pointing out that theguidelines prescribe the documentation and assurances thatmust accompany requests for NIH funding for research utiliz-ing pluripotent stem cells, and concluded that: “Compliancewith the Guidelines will be imposed as a condition of grantaward” (see note 74 infra).74 National Institutes of Health Guidelines for Research UsingHuman Pluripotent Stem Cells, 65 FED. REG. 51976 (Aug. 25,2000), corrected65 FED. REG. 69951 (Nov. 21, 2000). The orig-inal 60 day comment period was extended an additional 28 days,in response to public interest, and approximately 50,000 com-ments were received.


from frozen embryos left over from IVF.75 Researchwith hESC lines derived from cloned embryos createdthrough SCNT or embryos created specifically for re-search could not be funded.76 The guidelines also re-quire that (a) the embryos used for derivation be do-nated voluntarily,77 with no inducements, monetary orotherwise; (b) the decision to create the embryos andthe decision to donate the embryos are kept separate78;and (c) the decisions to discard the embryos and to do-nate them to science must be kept distinct. Throughsuch requirements, NIH officials expected to exertpressure on the procedures for deriving stem cells eventhough HHS-funding would not flow directly on thosecarrying out such procedures.

As a legal matter, the General Counsel’s memo-randum (and hence the NIH guidelines based on it)is at the least defensible; it exploits the failure ofthe statute’s drafters to express their intention in thelanguage of the law as clearly as they have ex-pressed it in reaction to the NIH policy.79 Strictlyspeaking, the acts that are ineligible for researchfunding under the appropriations statute do not in-clude the manipulation of human cells unless thosecells constitute an embryo, and a sound scientificbasis exists for concluding that hESCs are not inthemselves (that is, without being modified, such asbeing inserted into an ovum) capable of functioningas embryos nor developing into a fetus. The arrange-ments that flow from this attempt to separate fund-ing for use (permissible) and funding for derivation(forbidden) are harder to defend on logical, ethical,or practical grounds, however.

In the first place, the distinction between payingfor use of stem cells and paying for their derivationis merely a bookkeeping fiction. The funding pro-vided for studies using hESCs would of course flowdirectly to researchers deriving those cells, perhapseven in an adjacent laboratory. The only true dif-ference would be that the federal funds would notgo directly as salary and laboratory expenses for thederivation process but indirectly as funds to pur-chase hESCs, which funds would then pay thesalaries, laboratory expenses, and so forth. In effect,NIH would be supporting ES cell derivation throughan intermediary.

Given this connection, support for research usingthe cells is acceptable only to the extent that the pro-cess of derivation is acceptable. Plainly, for thedrafters of the NIH policy, that is the case: they didnot agree with the premise of the appropriations

rider and hence felt it was legitimate to find a meansof complying with the letter of the law while goingahead with what they regard as very important re-search to the extent possible. If they had regardedthe underlying activity as immoral or illegal, onehas to believe that they would have given greaterweight to the “ complicity” argument, namely that

75 In publishing its rules, NIH answered comments on the draftregulations addressed to the question of made-for-research em-bryos:

Some respondents were concerned that embryos might becreated for research purposes. Other respondents statedthere should be no distinction between embryos created forresearch purposes and those created for fertility treatment.Investigators seeking NIH funds for research using hPSCs[human pluripotent stem cells, the term used by NIH forhESCs] are required to provide documentation, prior to theaward of any NIH funds, that embryos were created for thepurposes of fertility treatment. President Clinton, many mem-bers of Congress, the NIH Human Embryo Research Panel,and the NBAC have all embraced the distinction betweenembryos created for research purposes and those created forreproductive purposes.

National Institutes of Health Guidelines for Research Using Hu-man Pluripotent Stem Cells, 65 Fed. Reg. 51976, 61976–79(Aug. 25, 2000).76 Id.77 The NIH guidelines specify that informed consent for stemcell derivation must be obtained from the individual(s) whowere part of the decision to create the embryos for reproduc-tive purposes, who would be the couple seeking fertility treat-ment rather than the gamete donors, if any.78 Section A2c of the NIH Guidelines imposes two requirementsaim to ensure this separation of the two decisions:

To ensure that human embryos donated for research were inexcess of the clinical need of the individuals seeking fertilitytreatment and to allow potential donors time between the cre-ation of the embryos for fertility treatment and the decision todonate for research purposes, only frozen human embryosshould have been used to derive human pluripotent stem cells.In addition, individuals undergoing fertility treatment shouldhave been approached about consent for donation of humanembryos to derive pluripotent stem cells only at the time of de-ciding the disposition of embryos in excess of the clinical need.

79 “Relying on a single deeply flawed legal analysis by the Gen-eral Counsel of the Department of Health and Human Services,the NIH guidelines mangle the plain meaning of the federal law,narrowing it to ban only funding of the specific act of destroy-ing the embryo.” The National Conference of Catholic Bish-ops/United States Catholic Conference-Pro-Life Activities,Talking Points: “Draft National Institutes of Health Guidelinesfor Research Involving Human Pluripotent Stem Cells,” June14, 2000. Some senators were also “deeply concerned with whatappears to be a unilateral attempt on the part [DHHS’s] part toeffectively undermine congressional intent, by circumventingthe current federal funding ban on embryo research.” Ida Chow,Update on Human Pluripotent Embryonic Stem Cell Research,Society for Developmental Biology, Feb. 1999.


anyone who profits from a wrong is morally impli-cated in it.80

At the same time, the position taken in the NIHfunding rules is unsatisfactory (on scientific and eth-ical/regulatory grounds) from the opposite perspec-tive: not because it in effect violates the appropria-tions law but because the system it adopts in orderto comply with the statute is untenable. Stem cellresearch—especially hESC research—is still ayoung field; its methods are still evolving. Indeed,absent the legal proscriptions, many researchers us-ing hESCs would be involved in deriving the cellsor in working closely with colleagues who do so,and their experience in using the cells, including theproblems they encounter, would help guide the de-velopment and modification of the derivation pro-cess. Yet the whole idea behind the General Coun-sel’s memo and the NIH policy is that derivationand use are two distinct processes that can be whollyseparated. Some researchers may be able to conducttheir work simply by ordering batches of stem cellsfrom Wi-Cell or another supplier the way theywould any other reagent or biologic. For them, thedistinction between use and derivation may reflectreality.81 But for the field as a whole, the imposi-tion of an artificial restraint on the methods of sci-ence that separates the process of derivation fromresearch utilizing the stem cell lines is likely to in-hibit progress in this field.82

Besides distorting science, the NIH policy un-dermines the federal government’s ability to shapethe ethics of stem cell research or, at the least, thelegitimacy of its efforts to exert control over the de-rivation process. One need not agree with all the de-tails in the NIH rules on the manner in which stemcells used in federally funded research must havebeen derived (I for one am skeptical about either thepractical ability or the desirability of keeping the is-sue of the eventual donation of some embryos to re-search out of the discussions and decisions that cou-ples make when beginning the IVF process) toapplaud the existence of these ethical standards. ButNIH’s moral leverage to insist that these rules befollowed is undercut by its own rationale. By claim-ing that federal funding of research using hESCsdoes not implicate federal sponsors in the deriva-tion of those stem cells, it would seem to have cutitself off from the derivation process. A usual ruleis that the government cannot achieve indirectlywhat it is precluded from doing directly.

The question of legitimacy is particularly pro-

nounced regarding the very points on which the fed-eral rules are most needed, namely in setting bound-aries, such as the prohibition on using stem cellsfrom made-for-research embryos or cloned em-bryos. The appropriations rider bans federal supportfor research that creates or destroys human embryos,which means that a federal agency cannot claim tobe implementing federal policy were it to limit fund-ing to research that uses only those ES cells thatwere derived from discarded embryos but not fromembryos created for the purpose of deriving EScells. Thus, under the Clinton-era rules NIH wouldbe hard pressed to justify differentiation based onthe type of embryos from which ES cells are de-rived, thereby losing an opportunity to oversee thederivation process directly and to enforce an im-portant ethical distinction.83

80 With rhetorical flourish, one commentator made this pointfrom the viewpoint of someone opposed to the destruction ofembryos:

[U]nder the rules that Bush is blocking, stem-cell researchwould not actually take the life of a single embryo. Re-searchers would use embryos that are being discarded any-way.

To anyone who actually believes that new embryos arejust as human as you or me, this is like saying, “Well, theHolocaust is going on anyway, so we might as well turn afew dead Jews into lampshades.” Accommodating to evil isevil.

Michael Kinsley, If You Believe Embryos Are Humans . . . thencurbing research on stem cells is an odd place to start pro-tecting them, TIME, June 25, 2001, at 80.81 Even when the stem cells used in a research project mostclearly resemble any other biologic or reagent purchased froma vendor’s pre-existing stock, one could say that the prospectthat scientists would want to purchase the cells may have mo-tivated the derivation of the cells, in which case, paying for theuse of the cells is still indirectly paying for their destruction.82 Alexander M. Capron, End Hypocrisy on Stem Cell Tests,LOS ANGELES TIMES, May 2, 2000, at B9. (“By banning federalfunding and hence federal oversight of stem cell research weare actually encouraging unregulated and profit-driven re-search.”).83 The desire that limits be placed on the manner in which stemcells are derived is so strong that some proponents of hESC re-search argued that the recent disclosure that the Jones Institutehad created embryos solely for the purpose of harvesting stemcells provided one further reason for the federal government tofund derivation from discarded embryos because doing so pro-vided a means for the NIH to exercise oversight over the wayin which the research would be conducted. Earl Lane, Stem CellAdvances Fuel Funding Debate; Some say federal money willpromote oversight, NEWSDAY (New York, NY), July 13, 2001,at A24.


2. Funding Research that Uses Only Exist-ing Stem Cell Lines: To achieve even greater dis-tance from the act of destroying embryos to obtainstem cells, some of the President’s advisors let it beknown in July that consideration was being givento limiting federal funding to research that woulduse already existing hESC lines. This position waspresented as a compromise that would allow fund-ing of some research while still literally adhering tothe President’s pledge not to support destruction ofembryos for research. Just as the Clinton rules—ofwhich this was a modification, rather than a rejec-tion—were crafted to comply with the letter (thoughnot the spirit) of the Dickey Amendment, this pro-posal struck some right-to-life advocates as adher-ing literally to the President’s campaign promise byadding “beyond those embryos already destroyed,”while not living up to the meaning of that promise.Nonetheless, some leading Catholic intellectuals ap-parently gave their blessing to such a compromise.84

It was explicitly discussed by the President when hemet informally on July 9 with bioethicists Leon Kassand Daniel Callahan, and it “crystallized” on Au-gust 2

when [Bush] talked to scientists at the NationalInstitutes of Health and was told that therewere perhaps more than 60 genetically diversestem cell lines already in existence, far morethan anyone had known.85

A week later, the President announced in a televisedspeech to the nation that he had “concluded that weshould allow federal funds to be used for researchon these existing stem cell lines, where the life-and-death decision has already been made.”86

While “some of the leading anti-abortion voiceson the Christian right . . . praise [Bush] for aSolomonic decision,” others who oppose federalsupport are vocally upset with the decision.87 In theirview, the moral separation from complicity in thedestruction of embryos achieved by the Bush policyis small: profiting from evil is still wrong. Support-ers of the decision point to the Catholic Church’s ac-quiescence in the use of vaccines that are grown ontissue taken from aborted fetus, yet the Catholic hi-erarchy remains among the religious groups mostcritical of the decision. Yet the stem cell lines werenot created simply to be there as objects of curios-ity but to be used in research. Thus, those who usethem seem at least indirectly implicated in the act of

derivation, since such use was the very thing con-templated by the derivers. To fight this conclusion,the Bush administration insists that the President willnot in the future extend federal funding beyond thecell lines available as of his August 9th address, al-though some—including Dr. Kass, whom Bush an-nounced would head a new President’s Council onBioethics, indicated that if a pressing need arose, thedecision could be “revisited.”88

Just as the President’s decision was accepted bysome who had opposed federal funding of hESC re-search (not the least because they had feared hemight make a worse decision), it was endorsed bysome who favor the research and were relieved tofind him making any compromise. In some ways,the reaction among scientists resembled the “stagesof dying” popularized years ago by ElisabethKübler-Ross, as they grieved, raged, bargained, andcame to acceptance. For two weeks after the an-nouncement, as the scientific community awaitedinformation on the cell lines mentioned by the Pres-ident, skepticism and disappointment were the ma-

84 “Spokesmen for the U.S. Conference of Catholic Bishops,which represents the church in the United States, specifically haverejected this idea, saying it would make the government complicitin embryo destruction. But one of the nation’s leading Catholicthinkers on abortion issues now is offering a different view. “Ican imagine circumstances in which this would not only be po-litically acceptable but could be a morally justified policy,” saidRobert P. George, a moral philosopher at Princeton Universitywho participates in a weekly telephone conference of Catholic in-tellectuals that often includes White House staff.

Another participant in the weekly calls, Rev. Robert A.Sirico, who leads a Michigan-based ethics think tank, said hehas told the White House that the compromise might be re-garded as acceptable and consistent with church teachings if itensures that the government never pays for the destruction ofanother embryo.

. . . If Bush moves in any way to support embryo cell re-search, it will be crucial that he win the support of at least someconservative Catholic leaders, George said. “Then they couldsay there’s a range of opinion and that this issue is not likeabortion or euthanasia,” which are uniformly condemned bychurch leaders and ethicists.”Aaron Zitner, Possible Stem Cell Compromise Cited by BushCatholic Advisors, LOS ANGELES TIMES, July 8, 2001, at A1.85 Katharine Q. Sellye with Frank Bruni, A Long Process LedBush to His Decision, N.Y. TIMES, Aug. 11, 2001, at A1.86 Bush’s Address on Federal Financing for Research With Em-bryonic Stem Cells, N.Y. TIMES, Aug. 10, 2001, at A16 (tran-script of speech in Crawford, Texas, prepared by the newspaper).87 Laurie Goodstein, Abortion Foes Split Over Bush’s Plan onStem Cells, N.Y. Times, Aug. 12, 2001 (division over Presi-dent’s decision is not Catholic versus Protestant but “pragma-tist versus purist”).88 Sharon Theimer, Thompson: Bush Firm on Stem Cells, As-sociated Press, Aug. 12, 2001.


jor emotions: 60 viable, distinct cell lines did not ex-ist; if they did, they were encumbered by patents andlicensing restrictions that would make it difficult toobtain them and burdensome to use them; the methodby which the cells had been derived (using bovineserum and mouse embryonic cells) meant they wouldnot be suitable for human therapy because of the riskof transmitting animal viruses; and in any case 60 celllines were not enough for the full range of researchbecause some of the lines either now or in the futurewould not be able to be coaxed into becoming thefull range of cell types, because they would not coverthe full range of human genetic diversity, and becausethe cells would eventually “wear out” in variousways. Many of those concerns were addressed on Au-gust 27, when the NIH issued an “Update.” NIHstated that ten laboratories in the U.S., Australia, In-dia, Israel, and Sweden have derived stem cells from64 individual, genetically diverse blastocysts that willbe included on a “Human Embryonic Stem Cell Reg-istry” provided that the labs certify that they meet thePresident’s criteria for use in federally funded re-search, namely:

[T]he derivation process (which begins with thedestruction of the embryo) was initiated prior to9:00 p.m. EDT on August 9, 2001. These stemcells must have been derived from an embryothat was created for reproductive purposes andwas no longer needed. In addition, informedconsent must have been obtained for the dona-tion of the embryo and that donation must nothave involved financial inducements.89

As information about the cells and how to obtainthem becomes available, it will be included in theRegistry, which will “be operational as soon as pos-sible” though not all the cell lines will be availablesoon, since time may be needed for the labs “to ex-pand to reach larger numbers for the purpose of dis-tribution” and since some lines “are still in the earlystages of characterization.” Indeed, the leader of thelaboratory in Sweden listed as having 30% of thetotal cell lines states that only 3 of the 19 lines areestablished, 4 are being studied, and 12 are still inearly stages and may yield far fewer usable lines.90

The NIH, noting that hESC research “is still in itsinitial stages,” admits that “to date no universallyaccepted standard [exists] for determining whatcharacteristics will predict the ability of such cellsto be, for example, differentiated or, ultimately, use-ful for the development of therapies.” Addressing

concerns that patents may impede research, the NIHreported that it had begun negotiating a materialtransfer agreement on behalf of NIH’s intramural re-searchers with the owners of the stem cell lines who“have publicly stated that they are very interested inmaking their cells available for use,” and it expectedthat such an agreement “may serve as a blueprint forseparate agreements by NIH-funded investigators,should their institutions choose to use it.”91

Plainly, many doubts remain about whether thePresident’s policy will allow American scientists toparticipate fully in the development of a new fieldthat was launched in 1998 by the announcement thathESC and hEGC had been successfully derived andcultured at two U.S. universities. While it is appar-ent that the Bush administration overstated what itwas offering—for example, in describing the sixty-plus lines as “robust and viable for research”—manycommentators apparently believe that the time hascome to step back from politics and begin trying towork with the cell lines, testing not only their util-

89 NATIONAL INSTITUTES OF HEALTH (NIH) UPDATE ON EXIST-ING HUMAN EMBRYONIC STEM CELLS, http://www.nih.gov/news/stemcell/082701list.htm (accessed 8/31/01). Interestingly,these criteria are much less detailed and restrictive than thoseadopted under the Clinton administration (in terms of informedconsent procedures, sources of the embryos, etc); furthermore,since a Registry of accepted cell lines will be established, a re-searcher receiving federal support need only ensure that anyhESCs being used come from such a cell line, whereas underthe policy that NIH was about to implement, research that pro-posed the use of human pluripotent stem cells, had to be for-mally reviewed by the Human Pluripotent Stem Cell ReviewGroup (HPSCRG), a working group of the Center for Scien-tific Review Advisory Council (CSRAC) to ensure that thehESCs used were produced in compliance with NIH guidelines.http://grants.nih.gov/grants/guide/notice-files/NOT-OD-01–003.html (accessed Aug. 29, 2001).90 Donald G. McNeil, Small Lab in Sweden Holds a Huge Troveof Stem Cells, N.Y. TIMES, Aug. 29, 2001. (“Those 12 perhapsought to be called potential cell lines,” said Professor Lars Ham-berger, a group leader. “If we get 3 good lines out of them we’llbe satisfied.”) Similarly, the small U.S. company that is secondon the list in terms of cell lines, CyThera of San Diego, CA,reports that its 9 lines are still being studied and will not beready for research use for months. Andrew Pollack, ObscureBiotech Company Becomes Big Player in Stem Cell World,N. Y. TIMES, Aug. 28, 2001.91 The holder of the principal patent in the field, the Wiscon-sin Alumni Research Foundation (WARF), in order to be ableto facilitate use of stem cell lines created using its method, re-cently sued the Geron Corporation, which holds exclusive rightsto develop six, potentially therapeutic types of tissue from stemcells; WARF is contesting Geron’s claim to an additional 12tissue types, which it wants to be able to license to other re-searchers. Sheryl Gay Stolberg, Suit Seeks to Expand Access toStem Cells, N.Y. TIMES, Aug. 14, 2001, at C2.


ity but also the ability and willingness of the labo-ratories that have produced them to make themavailable on reasonable terms. Only such steps willdetermine the point at which—as researchers arguedeven before the President’s decisions92—more celllines are needed for research.93

Of course, not all scientists or those who favor ex-panding hESC research have accepted the “proceed-and-then-reconsider” stance. Some American re-searchers—most publicly Roger Pederson whorecently left the University of California San Fran-cisco for the University of Cambridge in the U.K.—have gotten fed up with the barriers to stem cell andrelated biological studies and worry that the more lib-eral rules applicable in other countries will allow re-searchers there to outstrip their U.S. competitors.94

Carrying that one step further—and debunking thenotion that private funds will ensure that the researchis not unduly impeded here—Jim Clark, founder ofseveral Silicon Valley companies, has decided towithhold $60 million of the $150 million he hadpledged to Stanford University for a center for bio-medical engineering and science because he has con-cluded that the politicization of stem cell research inthe United States means that the “new future for med-

icine and biology and for resulting entrepreneurship”that he had intended to stimulate at Stanford will in-stead occur abroad, especially in the U.K.95

C. Federal Support for Deriving as well as Using Stem Cells

In the wake of the media attention to the three newways of deriving and culturing human pluripotentstem cell lines, President Clinton asked the NationalBioethics Advisory Commission (NBAC) to con-sider the issues involved in this field of research. Ina report to the President in September 1999, NBACmade thirteen recommendations.96 The heart of thereport is the Commission’s conclusion that an ex-ception should be made in current law specificallyto allow federal funding for research involving boththe use and derivation of stem cells from embryos.NBAC concluded that at this time only embryos leftover from IVF procedures—and not those createdfor research or through cloning—should be used asa source.97 NBAC’s recommendation that a couple’sdecision to discard IVF embryos should be separatefrom the decision to donate the embryos to re-search,98 was then reflected, and made more elabo-rate, in the draft regulations that NIH published three

95 “[W]ith no prospect of federal support, significant scientificinquiry in a field like stem cell research will stop. No researchleader can forgo federal money.

Denying financing for this biomedical research will drive the formation of a new pharmaceutical industry outside the United States. Federally funded research helpedcreate America’s economic leadership in the Internet andcomputer technology. . . . Restricting stem cell research foreven a few years simply means that scientists in the UnitedStates will not be pioneers. Others will own the patents andclaims, and a new pharmaceutical industry will thrive else-where.

I believe our country risks being thrown into a dark age ofmedical research. Biologists are at the threshold of the most im-portant set of discoveries in history, and rather than teach and lead,our politicians react and follow a conservative few. This legisla-tive action will cause the United States to miss a revolution in bi-ology. Meanwhile, in the United Kingdom a new industry will be born.

It is futile to think that private funding can make up whatis being lost to laws driven by conservative politics. I thereforehave reluctantly decided to suspend further contributions untilour lawmakers decide to pursue what I believe to be a rationalcourse in this vital part of our national future.”Jim Clark, Squandering Our Technological Future, N.Y. TIMES,Aug. 30, 2001, at A19, col. 2.96 National Bioethics Advisory Commission, ETHICAL ISSUES IN

HUMAN STEM CELL RESEARCH, VOL. 1: REPORT AND RECOM-MENDATIONS (1999).97 Id.98 Id. at 72.

92 “If human embryonic stem cells prove to be as variable inthis way as their mouse counterparts apparently are, then a po-litical compromise floated by the Bush administration in thestem cell debate may not be as practical as some had hoped.That possible compromise would limit the number of embry-onic stem cell lines, or colonies, that scientists could work on,thus limiting the number of embryos destroyed. But if seem-ingly identical cell lines are subtly different from each other, then some may have particular promise for certain uses—suchas to make new brain cells for Parkinson’s patients—and oth-ers may excel at other tasks, such as becoming cardiac tissuefor heart attack patients. ‘You may have to establish hundredsof lines to get the few you’d want to have,’ said John Gearhart,a stem cell researcher at Johns Hopkins University.”Rick Weiss, Clone Study Casts Doubt On Stem Cells; Varia-tions in Mice Raise Human Research Issues, WASHINGTON

POST, July 06, 2001, at A1.93 The short-term effects of Mr. Bush’s policy will be that a lotof important research gets funded using these lines. And that’sall for the good.

The long-term fate of stem cell research remains a poten-tially serious problem. . . . Mr. Bush’s compromise policy willbe a reasonable one only as long as the existing cell lines arecapable of supporting the research scientists need to perform.Editorial, How Many Lines? WASHINGTON POST, Aug. 31, 2001,at A22.94 See, e.g., Nicholas Wade, Clearer Guidelines Help Britainto Advance Stem Cell Work, N.Y. TIMES, Aug. 14, 2001, at A1;Edward Epstein, Senator Wants Stem Cell Limit Revised; Boxerasks Bush to Loosen Restriction, SAN FRANCISCO CHRONICLE,Aug. 24, 2001, at A2.


months later. In order to reinforce the voluntarinessof the decision and to diminish the risk of com-modification, NBAC also recommended that the saleof embryos be prohibited.99 Finally, NBAC urgedthe creation of a National Oversight and ReviewPanel to ensure that federally funded stem cell re-search is conducted according to ethical princi-ples.100 This Panel would also certify hESC andhEGC lines and maintain public registries and data-bases to ensure that research in this field is orderly.

The following year, Senators Arlen Specter (R-PA)and Tom Harkin (D-IA) introduced the Stem Cell Re-search Act of 2000, which largely embodied NBAC’srecommendations.101 Section 2 of this act wouldamend the law regarding stem cell research to allowfunding of research that involved the derivation ofstem cells from excess embryos created for IVF thatwould otherwise be discarded.102 The bill also restrictsthe sale of human gametes and embryos by federal re-searchers.103 Finally, the bill requires that all feder-ally funded research on human ES cells be reviewedand approved by an institutional review board whichwill follow guidelines issued by NIH.104 Having notbeen allowed by the Senate leadership to come to thefloor for debate and a vote during 2000, the bill wasre-introduced as S. 723 in the Senate on April 5, 2001and as H.R. 2059 in the House on June 5, 2001.

VI. CONCLUSION: THE NEED FOR OVERSIGHT

Behind the controversy over hESCs lies the over-arching issue of whether public support for research

involving human embryos is appropriate when alarge number of taxpayers find such work im-moral.105 In a democracy based both on majorityrule and on the protection of minority rights, arerules against supporting such research too deferen-tial to the minority, or would federal funding of theresearch constitute too insensitive an involvementof all taxpayers in actions that some of them finddeeply offensive?

At the moment, several of the policy options re-garding public support of embryonic stem cell re-search are put forward explicitly as compromises.Yet, they are rather unsatisfactory compromises inphilosophical as well as practical terms, as they failto come to grips with the question: are the scientificand clinical benefits reasonably expected fromhESC research sufficiently great to justify federalfunding of this particular activity in which some hu-man embryos will be destroyed in the first week oftheir existence? The central lesson of the contro-versy that has simmered and boiled since threegroups of scientists showed in 1998 that humanpluripotent stem cell lines could be established fromembryonic and fetal cells is that what is most neededis a mechanism for deciding the “justification” is-sue in a visible and accountable fashion. The frame-work for such a process was one of NBAC’s cen-tral recommendations106 and was likewise includedamong the 10 conditions that Sen. Tommy Frist (R-TN) placed on his support for stem cell researchwhich he announced at a Senate hearing on July 18,2001.107

the results of the protocols, which would permit the “justifica-tion” question to be reassessed in light of experience.107 Rick Weiss & Amy Goldstein, Frist Backs Stem Cell Fund-ing: Senate’s Only Doctor Supports Research, WASHINGTON

POST, July 19, 2001, at A1 (among ten “principles” are restric-tions on the number of embryo cell lines created with federalmoney, a preliminary limit of five years of funding, and cre-ation of an independent presidential advisory committee to keeptabs on the research); Sheryl Gay Stolberg, Key Bush Ally BacksStudies of Stem Cells, With Limits, N.Y. TIMES, July 19,2000(supports federal financing for hESC research “within avery carefully regulated, fully transparent framework”). Seealso John A. Robertson, Ethics and Policy in Embryonic StemCell Research, 9 KENNEDY INST. ETHICS J. 109, 131 (1999).

A more fruitful approach to research issues at the beginningof life is to recognize that for most persons the ethical or nor-mative questions that arise are less about duties intrinsicallyowed to embryos or fetuses than they are about symbolizingor expressing the high respect that most persons have for hu-man life generally. This respect is shown, not by banning allresearch with embryos or aborted fetuses, but by allowingsuch research only when good reason exists for engaging init and an institutional, or even national, review process to as-sess those reasons has been implemented.

99 Id. at 74.100 Id. at 76.101 Reintroduced this year as S. 723, The Stem Cell ResearchAct of 2001, 107th Cong. (2001)(amending Part H of the TitleIV of the Public Health Service Act, 42 U.S.C. §289 et seq.).102 Id.103 Id.104 Id.105 See John A. Robertson, Ethics and Policy in Embryonic StemCell Research, 9 KENNEDY INSTITUTE OF ETHICS JOURNAL 109,131 (1999): “Precisely because people differ so sharply over per-sonal spiritual and value commitments, one group should noterect its own view into public policy. Indeed, doing so exacts ahigh cost from those who would benefit from such research.”106 Recommendation 8 of the NBAC report urges DHHS to cre-ate a “National Stem Cell Oversight and Review Panel to ensurethat all federally funded research involving the derivation and/oruse of human ES or EG cells is conducted in conformance withthe ethical principles and recommendations contained in this re-port.” NBAC Report, p. 76. The panel, which would have “abroad, multidisciplinary membership, including members of thegeneral public,” would not only review protocols for the deriva-tion of ES and EG cells but also maintain a public registry of ap-proved protocols and certified cell lines as well as a database of


The U.K. has such an oversight body, the HumanFertilisation and Embryology Authority (HFEA),which also covers the more commonplace mattersof IVF and other fertility-related techniques throughits system of licensing fertility centers and re-searchers. That system goes back to the well-knownCommittee of Inquiry into Human Fertilisation and Embryology, chaired by philosopher MaryWarnock, created in 1983 by the government in re-sponse to criticism of Medical Research Councilregulations that allowed research on pre-implanta-tion human embryos in the lab. The Warnock Com-mittee reached conclusions very similar to those theEAB had reached five years earlier in its 1979 re-port on IVF research. The central conclusion was toapprove as ethically acceptable research with IVFembryos up to 15 days. That is the point when im-plantation occurs under normal circumstances andwhen such differentiation has occurred in the zygotethat twinning is no longer possible.108 Whereas theEAB’s report produced no official response and wasfollowed in the United States by heated political de-bates about IVF and now stem cell research, theWarnock Report led to the establishment of theHFEA, first as a voluntary and later as a mandatorylicensing authority in the U.K.109

When controversial issues arise, the HFEA ap-points a panel to review the issue and attempt to rec-oncile the technical concerns of scientists with themoral and social concerns of society.110 Although,the HFEA has not always been able to reach har-monious outcomes, the effect of the HFEA on IVFresearch in Britain is to provide a normalizing in-fluence that reassures the public that IVF researchis conducted as ethically as possible. In contrast, inthe U.S., with a prohibition on federal funding forIVF-related research, and no central authority to reg-ulate it, all embryo research is in private hands. Notonly is scientific inquiry primarily directed towardsdeveloping commercially viable products, but active

markets have developed for gametes with desirabletraits. Ironically, one of the objections to fundingIVF research was that it might lead to the creationof markets for human reproductive materials. If theIVF story foretells anything for the unfolding stemcell story, it is that the withdrawal of the federalgovernment from an arena may only add to the pro-cess of commodification, commercialization, andexploitation of the vulnerable.

As the President’s policy is implemented by re-searchers and scrutinized by the public, Congressought to be willing to ask whether a better policycannot be crafted. Full authority for federal agen-cies to fund research deriving and using hESCswould build a better scientific base, with the fruitsaccessible to all investigators, and would give fed-erally supported scientists full access to this impor-tant new tool. But such a policy must also provideethics oversight and guidance that should deter com-mercialization and encourage respect for all in-volved in stem cell research, including the donatedembryos.111

108 In Professor (later Dame) Warnock’s words, “It is thereforedifficult for me . . . to trace my origin as an individual beyondthe 14-day stage to the stage when I might have been two.”MARY WARNOCK, AN INTELLIGENT PERSON’S GUIDE TO ETHICS

43 (1998).109 The Human Fertilisation and Embryology Act 1990 createsthe Authority as a licensing and regulatory body (Schedule 2§3). Furthermore, the Act allows research on embryos to con-tinue until the formation of the primitive streak (Section3(3)(a)). Finally, the Act forbids payment for human gametes.110 For example, the process of sex selection of embryos usedin IVF became possible in 1989. When the Authority reviewedthese issues, they had no problem allowing sex selection againstdetrimental genetic traits. However, sex selection based on pref-erence was found to not be socially acceptable and forbade allcenters licensed under the Act from performing sex selectiontechniques for personal preference.111 I thank Michael Albrecht, Ph.D., USC Law Class of 2002,and Houman Ehsan, M.D., USC Law Class of 2004, for theirinvaluable research assistance.

Documents

Stem Cells: Ethics, Law and Politics