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Monitoring Stem Cell Research


Table of Contents

The President's Council on Bioethics
Washington, D.C.
January 2004
www.bioethics.gov



Chapter Three

Recent Developments in the Ethical and Policy Debates


The announcement of the Bush administration’s human embryonic stem cell research funding policy in the summer of 2001 certainly did not end the debates surrounding the issue. The policy offered a particular target to which participants in the debate could react, but the basic questions involved in assessing how the federal government should approach embryonic stem cell research remained just as relevant, and just as controversial, as they had been before. In this chapter, we offer an overview of that still continuing debate as it has developed in the past two years. Without attempting to provide anything like a full account of different positions and arguments, we hope, rather, to point to the major items under argument—to the issues that any interested citizen might wish to ponder. First, we will outline the general form of the moral argument as it has developed over time. Second, we will discuss specific questions and critiques regarding the current policy, as those have emerged in public discussion. Third, we will review the various positions on the moral standing of human embryos, seeking again to outline the chief fault lines in that continuing debate. And finally, we will highlight some critical ethical concerns that do not arise directly out of the debate over the moral standing of human embryos but that may be no less important to the larger question confronting the country.

This array of subjects includes both some that are clearly ethical questions and some that may fall closer to questions of policy. We take up both together because we believe both are essential to a full understanding of the issues involved and because even the policy debates—as understood and engaged in by participants on all sides—are clearly directed to a set of underlying moral issues and informed by ethical beliefs and opinions. Critiques (and defenses) of the present policy, and proposals of alternatives, are almost without exception based on moral grounds.

This chapter will, of course, revisit several of the themes raised in the previous chapter. There, our aim was to present some basic facts regarding the current policy, its context, and its execution. Here, we take up arguments on all sides of the issue—including those that dispute the understanding of the policy put forward by its authors and those that raise other issues or alternative courses of action.

While we will raise these arguments and counterarguments, examining problems, questions, and concerns, our purpose is not finally to assess the validity of the competing claims or to arrive at a conclusion, but—in line with the Council’s charge to monitor developments in this area—to present them more or less as they have appeared in the public debates of the past several years. This way of proceeding suffers from one especially prominent drawback: it tends to present all arguments as equal in importance or prevalence. We will seek to avoid this whenever possible, by offering some sense of which arguments have been most crucial for the public debate.


I. The Nature of the Moral Argument

Before entering upon a detailed review of the debates, we take a moment to consider the character of the moral reasoning and argumentation we will confront. Different participants in the stem cell debates tend to hold different views not only regarding individual substantive judgments, but also regarding the kind of moral question, in the most general terms, we are facing in deciding about stem cell research policy. At first glance, people seem to be disagreeing about whether a balancing of competing interests and goods is called for, or whether some one overriding moral duty ought to shape our judgment, though of course that dichotomy is not in every case quite so stark.

In casual conversation, and sometimes in more theoretical reasoning, moral questions are often analyzed in the language of “weighing” and “balancing,” or else in terms of overriding concerns, inviolable principles, or fundamental “rights.” These two sets of terms and metaphors point to two distinct ways of making difficult moral judgments. In some circumstances there need be no irresolvable conflict between the two approaches. Those who seek to respect fundamental rights and adhere to inviolable principles need not ignore the complexities of moral situations or the consequences of our actions when they form their judgments. Likewise, those who seek to weigh or balance competing goods may think of those goods as involving not only benefits to be realized but also principles to be upheld. There may also be circumstances, however, in which those differences that do exist between these two approaches constitute a fork in the road, constraining our decision. Thus, to take an example from outside the domain of bioethics, the principle that civilians should be safeguarded from direct, intended attack in time of war may be understood to trump all other competing goods (without denying the importance of those goods), or it may be understood as one good to be balanced against others. Which fork in the road of moral reasoning one takes at such a point will have a decisive influence on the character of the arguments employed and the conclusions reached.

This has often also been the case in the public debate over federal funding of human embryonic stem cell research. Many observers have agreed that federal policy must seek a certain balance between two competing goods or interests: the progress of medical research and therapy, and respect for nascent human life. Indeed, President Bush himself framed the issue in these terms, saying a few weeks before his decision was announced that his policy would “need to balance value and respect for life with the promise of science and the hope of saving life.”1 But not all participants in the debate have had the same idea of what such balance should entail and, therefore, how weight should be assigned to the competing demands.

For some, the degree of medical promise should profoundly affect the degree of government support for embryonic stem cell research. For them, the critical element (though of course not the exclusive one) in establishing policy must be scientific data about what might be achieved with human embryonic stem cells.2 The greater the promise of the research, the more support it should receive and the more it should outweigh reasons offered for opposing the techniques involved.3 On this view, the concern given greatest prominence and weight in reaching a judgment ought to be the very great good of medical progress toward the relief of suffering. Most of the arguments in favor of increased taxpayer funding of embryonic stem cell research have begun from this premise—explicitly or implicitly—and have proceeded by laying out the possible medical benefits of the research or the possible harms (to patients or to American science) of withholding support. We shall review a number of these lines of argument in more detail below. But it is worth noting at the start that most of them tacitly assume that the policy decision at hand ought to be based on a reasoned balancing of crucial concerns—all of which matter but none of which simply overrides the others.

Others, however, have suggested that at least a substantial portion of the opposition to the research rests upon the belief that human embryos should not be violated and therefore—if this claim is valid—that the threat to their life and worth cannot be justified by the promise of research.4 It follows, on this view, that the federal government should do nothing to encourage or support the future destruction of human embryos, regardless of the promise of research. What remains then to be considered is the extent to which the government might advance the additional aim of progress in medical research within the bounds of the principle.5 In this case, the moral reasoning is understood to be decisively affected by an unbreachable boundary, and only the extent of some particular provisions of the policy are left to be settled by a weighing and balancing of other priorities. Proponents of the various forms of this position generally argue that the claim of human embryos to our protection presents us with a fundamental duty, to be overridden, if at all, only in extreme circumstances, rather than with just one good to be balanced off against others.6

In presenting the matter this way, adherents of this view consciously appeal to the ethics governing research with human subjects, which obliges those engaged in efforts to advance knowledge and seek cures to keep from trespassing upon human safety, freedom, and dignity.7 The decades-old and nearly universal adherence of researchers to rules protecting human subjects, these commentators suggest, demonstrates that the needs of research are not always treated as paramount and that the scientific community itself joins the general public in recognizing instances in which research—however important—must be limited for ethical reasons.8 Researchers do not weigh the interests of human subjects against the importance of their work; rather they respect a principled boundary—that human subjects are not to be harmed or put at risk without their informed consent—the importance of which trumps even the most promising experiment. For some defenders of human embryos, the prospect of embryo research raises precisely these concerns; accordingly, they argue that this issue too should be decided on the basis of a moral rule, not by a shiftable tally on a balance sheet of benefits.9

But this assertion about the proper form of moral argument depends on the truth of the claim that human embryos are indeed human subjects of research. Therefore, one’s position in the debate about the basic character of the moral issue may depend, in many cases, on one’s understanding of the moral standing of human embryos. As we shall see, the question of the moral standing of embryos is by no means the only relevant question. But in the actual public debate, as it has developed, this question seems to have been most central and prominent and probably most responsible for shaping the different basic approaches pursued. It is this question that very often informs the differing views regarding which aims or goods are more weighty or which should not be compromised at all.

We turn next to arguments regarding that very issue: Which moral aims or which concerns should be given priority in shaping government policy toward human embryonic stem cell research?

II. The Moral Aims of Policy

A significant part of the public debate surrounding the policy governing funding of embryonic stem cell research has involved differing views of just which purposes or ideals should most directly guide policymakers in this arena. The current funding policy—while it appears to strike some balance between protecting human embryos and advancing biomedical research—seems to take as its overriding concern the insistence that the federal government not encourage or support the deliberate violation or destruction of human embryos. But a number of commentators in recent years—and, of course, particularly those who ascribe lesser moral status to human embryos—have proposed alternative principles to govern policy.

A. The Importance of Relieving Suffering

Many observers argue that the proper governing principle should be the duty to relieve the pain and suffering of others—the purpose that ultimately motivates the work of biomedical science. This aim is broadly, perhaps universally, shared. Indeed, the current policy, as outlined by its advocates, while it seeks to protect nascent human life, explicitly seeks to advance medical research as far as its authors believe is morally permissible. Some commentators argue, however, that the administration has chosen the wrong one of these aims as the governing principle of its approach.

The cause of curing disease has a human face, the face of a loved one or neighbor, bent under the suffering of an incompletely understood or treated disease. As a result, the aspiration to know is linked to a desire to relieve. How, wonder many commentators, could anyone think of withholding support for research that might yield therapies for devastating diseases and conditions such as spinal cord injury, diabetes, and Parkinson disease?10 Surely, they argue, the pain and suffering of those in need should outweigh concerns for human embryos frozen in a laboratory.11 Indeed, for many this is an especially critical issue in light of the likely ultimate fate of these embryos. Will they be frozen indefinitely? If not, then will they be thawed out and discarded and destroyed, or used to potentially benefit mankind?
One form of this argument, heard increasingly over the past few years, begins with data about disease prevalence and suggests that anyone who obstructs public funding of research that might someday help patients suffering from such diseases must bear some of the responsibility for their future suffering and (perhaps) death.12 Some opponents have countered that any assertion that makes relief of human suffering the highest moral principle to this extent might logically impugn any and all deflection of resources into less ultimate concerns such as recreation, beautification, or social ceremony. Others respond more directly that an unwillingness to violate one’s moral principles in order to help relieve the sick does not make one responsible for their sickness.13

In most cases, however, the arguments for grounding federal funding policy in the importance of biomedical research do not blame opponents for the suffering of the sick. Rather, they focus on the promise of bringing relief to those who most need it. They point to the immense benefits already delivered to us by modern medicine and argue that the federal government should advance this cause in whatever ways it reasonably can. Many advocates of this view agree that nascent human life should receive respectful treatment, but they argue that the claims of our duties to human embryos—whether in general or in particular circumstances, like those stored in fertility clinic freezers—cannot simply trump the claims of promising medical research and our duties to suffering humanity. The obligation to aid the sick, they contend, and the fact that the research in question might relieve the pain and terrible suffering of countless patients and their families, should lead us to do all that can reasonably be done to find treatments and cures, and to offer help. This does not mean simply ignoring the significance of human embryos, or taking lightly the decision to destroy them in research, but, they suggest, it should mean taking seriously the moral calling to help the suffering and deciding how to proceed based on more than one sort of obligation.14

In response, one commentator has argued in broad terms against the underlying assumption that the demands of biomedical research should somehow be seen as “imperative.” Such work, he contends, should not be seen as inherently and always obligatory, and claims to support it may be overridden even by a level of respect for nascent human life that does not suppose that embryos possess full human moral standing. He suggests that it is not at all obvious that individuals or the government have a definite responsibility to support such research or that such a responsibility would override other moral duties.15

Others point out that the duty to find cures for disease cannot be an unqualified or absolute imperative. Pointing to the present rules governing the treatment of human subjects in research, they argue that the case for embryonic stem cell research cannot rest on an alleged and overriding imperative to pursue that research. These rules prohibit certain sorts of procedures on human subjects of research, and the same, they suggest, should be required in stem cell research. Yet those who argue that the importance of medical research and treatment should override the aim of protecting human embryos presumably would not propose to override protections for human subjects in research on children or adults. Rather, they approach the present matter differently because they do not consider human embryos the developmental, anthropological, or moral equivalent of children or adults, or worthy of the same protection. The difference, therefore, has to do not so much with a dispute over the imperative importance of research, but rather (at least to a significant extent) with the status of nascent human life, which again turns out to be the fundamental point at issue.16

Nevertheless, the moral claims of medical research and treatment are extremely powerful in the debate over human embryonic stem cell policy, and they are acknowledged as profoundly important even by those who do not finally take them to be decisive. Most arguments in opposition to the present funding policy and in support of expanded embryonic-stem cell research are grounded in these claims.


B. Freedom to Conduct Research

Other opponents of the present policy argue not from the value of medical benefits but on the basis of freedom to conduct research, which they believe is the principle by which federal policy ought to be governed. They regard government restraints on scientific research as inherently offensive and generally unjustifiable.17 The cherished ideals of freedom of thought, freedom of conscience, and—specifically in this context—freedom of inquiry, trump concerns over the moral status of human embryos, they contend.18
The most common claim advanced for protecting research as a basic right (employed, among others, by the American Bar Association) involves some form of an appeal to the First Amendment’s protection of free speech, interpreted through the years by the Supreme Court to encompass free expression and perhaps freedom of inquiry and thought.19 Some argue that research is a form of expression, particularly when it is politically or socially controversial, and when restraints upon it are imposed for moral reasons.20 “One could make the case that research is expressive activity and that the search for knowledge is intrinsically within the First Amendment’s protection for freedom of thought,” says one ethicist.21

Others, however, contend that this claim, never tested in the courts, seems far-fetched. Most currently controversial biological research involves experimental manipulation of living matter, rather than theoretical exploration or mere observation of natural objects. It is therefore as much action as expression, as much creation as inquiry. It is difficult to see, they argue, how such activity (as opposed to the reporting of the results of such activity) could be classified as a form of expression. “Scientists may have the right to pursue knowledge in any way they want cognitively, intellectually,” argues one observer, “but when it comes to concrete action in the lab, that becomes conduct and the First Amendment protection for that is far, far weaker.”22

Moreover, argues at least one commentator, even if one did stipulate that research activity is to be protected from governmental proscription or restriction, it is far from clear that failure to provide federal funding would constitute such a restriction.23 Indeed, legislative and judicial precedents suggest it would not. The government routinely refrains from funding activities it otherwise permits or even guards as constitutionally protected. A line of Supreme Court decisions stretching from 1977 to 1991, dealing with abortion and government funding, established the principle that the Constitution does not require the government to fund even those activities that the Constitution protects.24 Because the only issue in the present debate is one of federal funding, the protected status of scientific activity seems not to be a determining factor.25

Finally, some critics of the case for a paramount right to research point again to the fact that scientific research—conducted both with private and (especially) with government funding—is already subject to certain restrictions, particularly with regard to protecting human subjects. The proposition that embryo research should not be subject to the same restrictions hinges on an argument about the standing of human embryos, rather than about the unrestrictable standing of research as such.26 Once more, an important part of the question turns on the status of extra-uterine human embryos.

C. The Moral Standing of Human Embryos

However they approach the matter, then, many people engaged in the debate over federal funding policy find they must consider the fundamental question of the moral standing of human embryos: What are early human embryos, and how should we regard them morally? Approaches to the question of federal funding of embryonic stem cell research that propose some other guiding principle—relief of suffering, freedom of research—seem almost by necessity to assume that human embryos do not possess the same human moral standing as persons already born.27 Conversely, if human embryos ought rightly to be treated as inviolable—as some have argued—then questions of balancing other goods or giving priority to other principles are largely rendered moot. Thus, to many observers, some of the central questions in this arena would appear to be those that surround human embryos: How ought we to think about and act toward human embryos? Should all ex vivo human embryos be treated the same, or are some, because of their circumstances, origins, or prospects, to be treated differently from others? Or are embryos of sufficiently little moral significance that we should simply decide the funding question solely on the basis of the merits and promise of the proposed biomedical research?
We shall, in due course, review the recent arguments on these critical questions. But before doing so, we examine a series of other more specific objections to the present policy. These arguments recognize that the current policy rests on the conviction that federal funds should not support or encourage the violation or destruction of human embryos. Rather than disputing this premise, a number of commentators—including both supporters and critics—have assessed the policy on its own grounds and judged it against its own claims and terms. As a result, several general categories of criticism of the policy itself have emerged.


III. The Character of the Policy

In addition to debating which aims ought to guide federal policy, many observers in the past two years have also assessed the particulars of the present funding policy, considering them in scientific, political, and moral terms. Critics have generally found fault with the policy through one or more of three general lines of argument: that it is arbitrary, that it is unsustainable, and that it is inconsistent. Defenders of the policy, meanwhile, have usually sought to counter these critics on these terms and to rebut these assertions and criticisms.

A. Arbitrary

One quite common line of argument criticizes the present funding policy as essentially arbitrary, because it relies on what is deemed a capricious cutoff date. Cells derived from embryos destroyed on August 9, 2001 are eligible for federal funding, but those obtained from embryos destroyed the next day are not. The only difference is the date of embryo destruction, argue some critics, and what moral difference could that possibly make? If the policy of funding human embryonic stem cell research serves a genuine good, these commentators suggest, would it not be equally good regardless of when the cell lines were derived? Would it not, therefore, make sense to permit funding for all cell lines derived on either side of the date, provided they are otherwise eligible?28 If, on the contrary, federal funding of embryo research is unacceptable, then it should simply not be allowed at all, regardless of when cell lines were first derived.29 “It is difficult to see,” writes one critic, “what ethical reasoning would commend a policy that takes as its central distinction the time chosen for political convenience to deliver a presidential address.”30

In response, some supporters of the policy contend that while the cut-off date (August 9, 2001) certainly has no inherent moral significance, it acquires moral meaning by the simple fact that it was the operative date of a newly announced policy that turned on a crucial distinction between the “up-until-now” and the “from-now-on,” between past (irrevocable) deeds and future (preventable) ones. That date of announcement was the line between past embryo destruction, which could no longer be undone, and future embryo destruction, which could still be influenced by the federal government’s funding rules. If the policy sought to avoid encouraging or offering incentives for any future destruction of human embryos, they argue, then drawing a hard line between past and future would be indispensable. That line could only reasonably be drawn at the moment of the decision’s announcementi (or before it), since drawing it at some point in the future would create a powerful incentive to quicken the pace of work until the cut-off date arrived. The date, they say, is therefore not a morally arbitrary marker in the context of the policy, but is rather a crucial and unavoidable element of the policy’s logic.31

B. Unsustainable

A further, and more common, critique of the current policy suggests that its approach cannot be expected to hold over time and that it will fairly quickly prove unsustainable.

One form of this argument suggests that the policy has created a situation in which scientists may make some progress using existing stem cell lines but would then be prohibited from capitalizing on what they have learned and making further progress using stem cell lines not now eligible for federal funds. As the editors of the Washington Post put it: “Mr. Bush’s compromise policy will be a reasonable one only as long as the existing lines are capable of supporting the research scientists need to perform.”32 Indeed, some have argued that by explicitly encouraging and speaking of the potential medical value of human embryonic stem cell research, the President himself created the circumstances that will make the constraints of the policy unsustainable. “Bush’s decision was at its core an endorsement of the promise of human embryonic stem cells and their importance to the fledgling field of regenerative medicine,” wrote one critic, and if that is the core message of the decision, then the resulting policy seems insufficient.33

Others, arguing on more practical grounds, claim that, regardless of the reasonableness of the principle behind the policy, its effects will prove unbearable for American scientists, who will then force a reconsideration.34 The limits placed on funding in the current policy, several observers have predicted, will seriously hamper and hold back embryonic stem cell research work in the United States, perhaps causing prominent scientists to leave the country in search of greater support abroad.35 If that were to occur, it is argued, the policy would prove genuinely damaging to American science, and therefore to the national interest, and would need to be changed.36

In response to this specific point, some defenders of the policy have noted that for the time being there has not been news of any notable migration of prominent stem cell researchers to foreign countries, that federal funding is now available with no ceiling on its amount, and that American researchers can continue to work with private funds.37

But even apart from worries about a “brain-drain” in the field, some have argued that both the lack of funding, and particularly the complexity of the set of conditions under which research using such funding may be conducted, is preventing progress in research and discouraging even private funding in the field,38 and that the lines made available simply will not be enough,39 or indeed that they have already proved insufficient.40 Some argue that the very low number of applications submitted to the NIH for postdoctoral and training projects using the approved stem cell lines provides striking evidence for the chilling effect of the current “in limbo” situation. Some have also suggested that safety issues connected with the way the eligible lines have been derived and developed may make them less suitable for use in human trials and treatments, thus making other cell lines necessary (although presentations before this Council by NIH Director Elias Zerhouni and FDA Commissioner Mark McClellan have contradicted some of these claims).41 Others, meanwhile, worry that the eligible lines do not offer sufficient genetic diversity to be adequate for research needs or for eventual therapies.42 As scientists make their case that important work is being hampered, it is argued, the policy will prove unsustainable politically and practically.43

A similar argument has also been made in nearly the opposite terms. That is, some have said that if or when ongoing embryonic stem cell research produces a spectacular breakthrough in understanding or treating disease, the pressure to alter the policy would prove unstoppable.44 This way, whether the future brings announcements of great progress, or whether it brings no news of advances, the result will be pressure for a policy that funds research more broadly.

Those defenders of the policy who have addressed these claims of unsustainability have pointed out that the present policy does not limit the amount of federal funds available to the kind of research that may be performed with the approved cell lines. They also point out that much of the pioneering work in mouse stem cell research was done using very few (approximately five) cell lines 45 (though of course the challenge of working with human cell lines is more complex and daunting). But they have also generally pointed to the policy’s stated grounding in principle—a principle that would not change in light of scientific advances or delays. In August of 2001, for instance, Health and Human Services Secretary Tommy Thompson told reporters that “neither unexpected scientific breakthroughs nor unanticipated research problems would cause Bush to reconsider” the approach drawn by the policy, because it is based on “a high moral line that this president is not going to cross.”46 As another observer has put it: “The general question is, well, will these cell lines be enough . . . and a non-complicity argument [like the one implied by the policy] will only work if the answer to that question is well, I guess they’ll have to be enough.”47 Or, put differently, if the policy is founded primarily in a determination to prevent government funds from encouraging the destruction of human embryos, and only secondarily in a judgment about the value of embryonic stem cell research, then advances in research alone (or the absence of advances alone) would not be sufficient to overturn it. If it is sound before such advances, some argue, it would still be valid after48—though again, of course, whether it is right to begin with is itself a point of great contention.

C. Inconsistent

In responding to critiques like those just discussed, defenders of the administration’s policy generally point to the principles that define the approach of the policy, as partially laid out in the previous chapter. But some criticism of the policy, directing itself precisely to the claim of consistent adherence to principle, has charged that the policy is morally contradictory, or at least inconsistent, in its own terms.

One common form of the charge of inconsistency concerns the distinction the policy tacitly draws between public and private funding. The current policy addresses itself only to federal funding of embryo research and is silent on the conduct of such research in the private sector. But the source of funding, this line of criticism suggests, could have no bearing on the question of the moral status of human embryos or the propriety of using them in research. If federal funding for research that destroys human embryos is so troublesome, then why should such research be allowed to proceed when privately funded? Acting to restrict one but not the other may be prudent, but it seems inconsistent.49 Indeed, by implicitly excluding such research from federal guidelines, it may actually encourage more reckless practices and may simply transfer the problem of complicity to the private sphere, where it is even more difficult to monitor and moderate the uses to which human embryos are put. Though these critics understand that the President cannot simply ban embryo research by himself, they argue that he could attempt to convince the Congress to do so, and he could have made such an attempt as an element of his funding policy decision. But he did not—thus bringing into question (for these critics) not only his commitment to the principle articulated by the policy, but also his own view of the moral standing of human embryos, which the policy itself does not make simply apparent.50 Moreover, critics argue, some prominent defenders of the policy, by making the fact of ongoing private research an element of their defense, might be said to contribute to these doubts about its grounding in consistent principle.51

There may be some political or structural reasons for drawing a distinction in federal policy between what is funded and what is permitted. Questions of federalism and other legal realities no doubt enter the picture, and indeed those who oppose the destruction of human embryos are, in many cases, actively seeking prohibitions on all embryo research in individual states.ii But, critics point out, they generally say little on the larger question of permissibility at the federal level. By making funding the center of concern, these critics argue, the policy puts into question the importance of preventing embryo destruction more generally, casting some uncertainty over the relation of that policy to one or another position regarding the moral standing of early human embryos.

A related criticism contends that the distinction drawn between research practices in which human embryos are destroyed and research practices that use the products of previous embryo destruction is itself inconsistent—a distinction without a difference, drawn for political cover.52 “Pretending that The Scientists who do stem cell research are in no way complicit in the destruction of embryos is just wrong, a smoke and mirrors game,” writes one critic. “It would be much better to take the issue on directly by making the argument that destroying embryos in this way is morally justified—is, in effect, a just sacrifice to make.”53 Similar objections have also been raised by critics on the other side of the embryo question, who believe that embryo destruction is morally unjustified and that the present policy does not sufficiently distance the federal government from such destruction. “The federal government, for the first time in history, will support research that relies on the destruction of some defenseless human beings for the possible benefit to others,” one critic contended in the immediate wake of the August 9, 2001 announcement. “However such a decision is hedged about with qualifications, it allows our nation’s research enterprise to cultivate a disrespect for human life.”54

A further critique of the policy on grounds of inconsistency focuses more particularly on specific elements of the implicit claim to non-complicity, discussed in the previous chapter. If, as many of its advocates argue, the policy takes embryo destruction to be essentially a morally unjustifiable act, and if its provisions aim to make use of the irreversible consequences of that act without in any way encouraging or abetting the act itself, then, critics contend, it is curious that the policy would insist on requiring (in addition) that the eligible stem cell lines must have been obtained from embryos originally intended for reproduction and used with donor consent and without financial inducements. If embryo destruction is in principle a wrong, and if the policy’s provisions seek only to keep the federal government from complicity in that wrong, then why should it matter how precisely the wrong was originally committed? The presence of these conditions, it is argued, suggests that the policy is not in fact based in a consistent and principled adherence to the proposition that human embryos should not be destroyed. Indeed, some have argued that this character of the policy suggests that its authors, including the President, may not hold the view that human embryos deserve the same protections as human children or adults. These critics suggest not so much that the current policy is necessarily inconsistent, but that it may only be consistent with a view of human embryos as possessed of intermediate or indeterminate moral standing, rather than a view that holds that human embryos ought simply not to be destroyed for the benefit of others.55

In response to these last arguments, some have suggested that the qualifying conditions included in the policy reflect a secondary commitment to long-standing principles of human-subject and embryo research and a recognition of pre-existing standards in such research, rather than a contradiction of the fundamental commitment to avoiding any support for the destruction of nascent human life. The government, they argue, has multiple aims in this area, and these need not undercut each other. In addition to discouraging the creation and use of embryos for purposes other than producing children, one commentator argues, the government also seeks to support the requirement for informed consent to all procedures involving human subjects and to discourage commercial trafficking in human material.56 Another observer has suggested that the additional conditions are an expression of the fact that some standards for stem cell derivation did exist before August 9, 2001, including those reflected in the Clinton administration’s funding guidelines.57 Even in rejecting the legitimacy of the act of embryo destruction and seeking to discourage it in the future, it is still reasonable to recognize the value of those earlier standards. The policy, it is argued, while establishing a new standard, still takes account of previous standards.58

In response to the more general complaints of inconsistency, defenders of the policy, within and outside the administration, have described the present policy as both principled and prudent. The policy, as articulated by these defenders, aims (at least minimally) to uphold and advance the principled conviction that the federal government should not offer support or incentives for the destruction of nascent human life for research. At the same time, they say, it seeks, as much as reasonably possible within the bounds of the principle, to benefit from the results of embryo destruction that has already occurred and can no longer be undone.59 As President Bush put it in announcing the policy, “This allows us to explore the promise and potential of stem cell research without crossing a fundamental moral line, by providing taxpayer funding that would sanction or encourage further destruction of human embryos that have at least the potential for life.”60 The policy, argue some of its advocates, aims to put into practice the moral principle of not destroying nascent human life, even if it does not do so on every possible front, or to the greatest possible extent.

Regarding the alleged inconsistency of withholding federal funding but not calling for a ban on all private embryo research, some have pointed out that the Dickey Amendment, under which the President was acting, is itself a “don’t fund, don’t ban” law. Moreover, they argue that neither statesmanship nor prudence requires that the President do battle with what is settled practice (the free use of embryos in private-sector research) or push zealously against everything to which he is morally opposed, especially in a pluralistic society that is deeply divided on the moral issue. An analogous case may be found in the administration’s approach to abortion, a practice that the President says he opposes deeply on moral grounds: the administration supports the legislative ban on federal funding, but has not called for a constitutional amendment that would ban abortion. As President Bush told the pro-life “March for Life” participants in January 2002: “Abortion is an issue that deeply divides our country. And we need to treat those with whom we disagree with respect and civility. We must overcome bitterness and rancor where we find it and seek common ground where we can. But we will continue to speak out on behalf of the most vulnerable members of our society.”61 In a similar way, its defenders contend that the current administration policy on stem cell research funding keeps the public ethical conversation open, may be acceptable to some individuals who hold that human embryos possess an intermediate or unknowable moral standing, and, at the same time, also advances the cause of those who contend that human embryos should be protected from destruction altogether.62

The present funding policy has also been defended from the charge of inconsistency on rather different grounds, which, for their advocates, carry different consequences for future federal funding. This defense contends that, if the early embryo is morally equivalent to a child, then the proper moral response would be to ban all future embryo destruction and all stem cell research (public and private) on embryos destroyed after August 9, 2001, and not merely deny it federal funding. Confronted with a practice that involved killing children so that their organs could be used to save the lives of others, advocates of this view contend, no one would simply deny it federal funding while allowing the gruesome practice to continue. But, they point out, there is no reason to attribute to the current funding policy the assumption that the early embryo is morally equivalent to a child. In fact, they contend, the President has never said that early embryos are inviolable, or are persons, or morally equivalent to children. While President Bush explained his funding policy by arguing that “it is unethical to end life in medical research,”63 he has not sought to prohibit privately-funded embryonic stem cell research. This leads some to conclude that implicit in the President’s policy is either the view that the embryo has an intermediate moral status (worthy of serious moral consideration as a developing form of human life) or uncertainty about its moral status. Those who interpret the President’s policy in this way point out that, in his address to the nation on stem cell research, he spoke in terms of a human embryo’s “potential for life”:
 
Research on embryonic stem cells raises profound ethical questions, because extracting the stem cell destroys the embryo, and thus destroys its potential for life. Like a snowflake, each of these embryos is unique, with the unique genetic potential of an individual human being.64

This, they contend, does not constitute an argument for treating human embryos as possessed of fully human moral standing.65

If the present policy is seen to reflect either the intermediate or uncertain view of the moral standing of human embryos, these advocates argue, it is not inconsistent to withhold federal funding, at least for now, when the medical benefits of stem cell research are still speculative, while permitting privately funded embryo research to proceed. They argue that restricting or limiting federal funding is a reasonable way of registering either doubt about the moral status of the embryo, or the moral unease felt by someone who takes nascent human life seriously and does not want it used wantonly, and who therefore wants scientists to prove the promise of this research before permitting them to go further with the support of federal funding. Indeed, they argue, this interpretation is consistent with the President’s words in his August 9th address:
[W]hile we’re all hopeful about the potential of this research, no one can be certain that the science will live up to the hope it has generated. . . . Embryonic stem cell research offers both great promise and great peril. So I have decided we must proceed with great care.”66

Viewing the administration’s policy as based on an intermediate or uncertain view of the moral standing of human embryos also makes plausible, in the view of these observers, the fact that the President has neither called for a ban on privately funded embryo research, nor called upon scientists to desist from research on stem cell lines created after August 9, 2001. They contend that it also makes sense of the requirements, discussed above, that stem cell lines created before that date must, in order to qualify for federal funding, be derived from excess embryos created for reproduction, with donor consent, and without financial inducements.
Those who interpret the policy as reflecting an intermediate or uncertain view of the moral status of human embryos argue further that, if embryonic stem cell research vindicates its promise, there would be no categorical reason to prevent a reconsideration of federal funding in the light of medical advances. A further implication is that people may reasonably draw different conclusions about whether this principle justifies federal funding of stem cell lines derived after August 9, 2001 provided they are derived from embryos left over from IVF procedures, donated with consent, and without financial inducement.67 Although the President has declared that he regards destructive embryo research as unethical without additional qualifications,68 and although HHS Secretary Tommy Thompson has said that scientific advances would not cause the President to reconsider his policy,69 those who interpret the President’s policy as reflecting an intermediate or uncertain view of the embryo argue that the moral logic of this principle admits the possibility that significant medical breakthroughs could justify a reconsideration.


IV. The Moral Standing of HUMAN Embryos

Many elements (though, as we shall make clear, not all elements) of the ongoing debate about federal funding of human embryonic stem cell research seem, as we have reviewed them, to turn on a basic disagreement about the nature, character, and moral standing of human embryos. Public debate over the moral standing and appropriate treatment of human embryos has been quite contentious and divisive in recent years. In part, this had to do with its almost inevitable entanglement with the abortion debate, itself a deep and thorny controversy in America. In part, too, this has been connected to the fact that the question of the moral standing of human embryos touches many other fundamental moral and existential questions involving human origins, human dignity, the moral significance of our biology, and its relation to numerous traditional and widely shared moral teachings.70 Differences of opinion on the moral standing of human embryos often suggest differences on these larger questions of overall worldview.71 Nonetheless, the question of the moral standing of human embryos itself has been taken by nearly all commentators to be amenable to human reason and argument, and a lively debate has raged despite (or perhaps precisely because of) these widely diverging starting assumptions.

In the public arena, the question of the moral standing of human embryos has often been summed up in the question, “When does (a) human life begin?” This question suggests something of the quandary, although the academic and intellectual debate generally takes a somewhat more nuanced question as its starting point. That question has as its unstated premise the fact that under normal circumstances we regard all born human beings (from newborns through adults) as possessing equal moral worth and meriting equal legal protection. It then reflects upon the ways in which human embryos are similar and different from live-born human individuals, the moral significance of those similarities and differences, and therefore whether embryos should or should not be afforded protections.72

The first and most common recourse in seeking an answer to such questions has been human biology, and particularly human embryology. Nearly all participants in the dispute make some reference to biological findings, whether to claim that they teach us about an embryo’s essential continuity with and similarity to human beings at other stages of life, or to argue that they reveal profound and morally meaningful discontinuities between embryos and live-born persons.

While we examine these differing contentions, it is crucial to remember—as several commentators in recent years have noted—that the biological findings, however relevant, are not themselves necessarily decisive morally.73 They may serve better to challenge moral positions founded on erroneous assumptions than to ground some positive moral affirmation or conclusion. For example, a recognition of biological continuity might in some measure undermine the argument that embryo destruction is permissible when certain biological markers or states of development are absent. But it would not by itself show indisputably that embryos are to be treated as simply inviolable.74 Meanwhile, recognizing the biological significance of some particular point, marker, characteristic, or capacity would not, in itself, imply some decisive moral significance. A description of early embryonic development is necessary though not sufficient to an understanding of the nature and worth of an early embryo.75 It is not sufficient because any purely biological description requires some interpretation of its anthropological and moral significance before it can function as a guide to action.76

With these provisions in mind, we offer the following brief review of developments in the debate over the moral standing of human embryos in the past several years.iii

A. Continuity and Discontinuity

Many participants in the debate take the question of the biological continuity or discontinuity between nascent and later human life to be crucially significant. Some argue that the fundamental organismal continuity from the moment of fertilization until natural death means that no lines can be drawn between embryos and adults. Others argue, on the contrary, that some particular point of discontinuity (or the sum of several such points) marks a morally significant distinction between stages, which difference should guide our treatment of human embryos.

1. The Case for Continuity.

Many of those who seek to defend human embryos base their case on some form of the argument for biological continuity and sameness through time. For example, they argue that a human embryo is an organic whole, a living member of the human species in the earliest stage of natural development, and that, given the appropriate environment, it will, by self-directed integral organic functioning, develop progressively to the next more mature stage and become first a human fetus and then a human infant. Every adult human being around us, they argue, is the same individual who, at an earlier stage of life, was a human embryo. We all were then, as we still are now, distinct and complete human organisms, not mere parts of other organisms.77

This view holds that only the very beginning of a new (embryonic) life can serve as a reasonable boundary line in according moral worth to a human organism, because it is the moment marked out by nature for the first visible appearance in the world of a new individual. Before fertilization, no new individual exists. After it, sperm and egg cells are gone—subsumed and transformed into a new, third entity capable of its own internally self-directed development. By itself, no sperm or egg has the potential to become an adult, but zygotes by their very nature do.78

Many authors therefore regard the activation of the oocyte (by the penetration of the sperm)79 or the completion of syngamy (the combining of paternally- and maternally-contributed haploid pro-nuclei to result in a unique diploid nucleus of a developing zygote) as a meaningful marker of the beginning of a new human life worthy of protection.80 After this point, there is a new genome, in a new individual organism, and there is a zygote (single-celled embryo) already beginning its first cleavage and embarking on its continuous developmental path toward birth.

All further stages and events in embryological development, they argue, are discrete labels applied to an organism that is persistently itself even as it continuously changes in its dimensions, scope, degree of differentiation, and so on. We can learn names for the various stages as if they were static and discrete, but the living and developing embryo is continuously dynamic.81 More to the point, in the view of these commentators no discrete point in time or development would seem to give any justification for assuming that the embryo in question was one thing at one point and then suddenly became something different (turning, for example, from non-human to human or from non-person to person). None of the biological events (or “points” in processes), they contend, is sufficient to tell us what we are morally permitted or obligated to do to human embryos, in the absence of one or another additional premises that shape one’s view of these biological events. And if one’s guiding premise is that all human persons possess equal moral standing—regardless of their particular powers, size, or appearance—then there are no grounds for denying the earliest human embryo full moral standing as a person. 82

Some critics of this position argue that it makes too much of mere genetic identity and (uncertain) potential or that it does not make enough of present condition and the significance of development itself.83 There is more to being human, some observers argue, than possessing a human genome or spontaneous cell division, and it matters that the early human embryo is but a ball of cells, without sentience or sensation and without human form.84 It matters, too, they argue, that an ex vivo human embryo does not have the potential to develop independently, without further technical intervention.85 Indeed, some argue that a human embryo in its earliest stages is essentially no different from any human tissue culture in the laboratory,86 or that, because the ex vivo embryo cannot develop if left to itself, it cannot be thought of as truly continuous with more developed human organisms. It may be, in the description of one observer, not much different from a pile of building materials stored in a warehouse.87

Nonetheless, advocates of the argument from continuity suggest that it is dangerous to begin to assign moral worth on the basis of the presence or absence of particular capacities and features, and that instead we must recognize each member of our species from his or her earliest days as a human being deserving of dignified treatment. They contend that a human embryo already has the biological potential needed to enable the exercise, at a later stage of development, of certain functions. Sentience and sensation come in later in the process of development, but their seeds are there right from the beginning. And the fact that an embryo cannot develop outside the body is not an argument for leaving it outside the body. There is, they argue, no clear place to draw a line after the earliest formation of the organism, and so there can be no stark division between the moral standing of nascent human life and that of more mature individuals.88

2. The Case for Meaningful Discontinuity and Developing Moral Status.

Many other observers, however, argue that some biologically and morally significant discontinuities do in fact present themselves in the course of early human development. These arguments generally do not simply hinge on biological descriptions—which are, in the absence of analysis, largely devoid of obvious moral significance—but instead begin from some implicit or explicit claim regarding the importance of a particular feature, capacity, form, or function (or the progressive accumulation of these) in defining a developing organism as meaningfully a member of the human race.iv Not simply grounded in biology, they appeal also to a moral or even metaphysical claim about the meaning of humanity.89They suggest that the developing human organism might become (at once or progressively) deserving of protection as it becomes able to feel pain, or to exhibit neural activity, or rudimentary features of consciousness, or some elements of the human form, or the capacity to function independently—or as it progressively exhibits more and more of these or other criteria. Until that time, many argue, a developing human deserves some respect because of what it might become, but not protection on par (or nearly so) with that afforded to fully human subjects.90 They suggest that genetic identity and organismic continuity are not sufficient; what matters is present form and function, more than mere potential.91

Several particular putative discontinuities (and combinations of them) have been proposed as candidates for the division between early stages, when a human embryo may be disaggregated for research, and later stages, when it deserves some greater level of protection.

(a) Primitive streak: The most popular candidate for a meaningful point of discontinuity is the appearance of the primitive streak, the earliest visible “structure” that defines the region of the embryo along which the vertebral column will form. The primitive streak generally appears around the 14th day after first cell division. It is taken to indicate the anterior-posterior axis of an embryo (in vertebrates), although recent studies suggest that polarity may be established much earlier, and in fact may be indicated by the point at which the sperm enters the egg.92
A principal reason for the importance placed on the primitive streak has to do with the biology of twinning. Prior to the appearance of the primitive streak, an embryo may (rarely, and for unknown reasons) divide completely to form identical twins. Some conclude that individuality must not yet be established, since the embryo might yet become two embryos.93 Since individuality is essential to human personhood and capacity for moral status, since individuality presumes a definitive single individual, and since the singularity of the embryo is not irrevocably settled prior to the appearance of the primitive streak, they argue that the entity prior to the primitive streak stage lacks definitive individuality and hence also moral status.94 Critics of this line of reasoning point to the low statistical probability of monozygotic twinning: one in 240 live births (though rates clearly vary among populations in different regions, and precise figures probably cannot be known because some zygotes that split likely later fuse into one, and some singleton births may conceal a twin who died early in gestation). Critics also point to evidence that twinning results, not from an intrinsic drive within the embryo, but from a disruption of the fragile cell dynamics of embryogenesis. Evidence for this, they suggest, may be seen in the increased incidence of monozygotic twinning (up to tenfold in blastocyst transfer) associated with IVF. This suggests, in their view, that twinning is neither a proof of the absence of an integrated individual organism with a drive in the direction of development nor a demonstration ex post facto of the absence of moral worth of the embryo before twinning.95
Nonetheless, for this reason, and for others (discussed below) having to do with the formation of the nervous system, the primitive streak has often been taken to be a highly significant marker of embryological development, and many commentators suggest it as a reasonable candidate for a meaningful point of discontinuity. For this reason, many supporters of embryo research regularly propose the 14th day of development as a logical stopping point for permissible embryo research.96
(b) Nervous system: A second argument for discontinuity focuses on the developing nervous system. Many observers regard the nervous system as an especially important marker of humanity, both because the human brain is critical for all “higher” human activities, and because the nervous system is the seat of sensation and, especially relevant to this case, the sensation of pain.
Proponents of this view hold that before an embryo has developed the capacity for feeling pain (or, in some forms of the argument, before sentience), we cross no crucial moral boundary in subjecting it to destructive research.97 For some, this is taken to mean that the primitive streak, as the first marker of a future nervous system, is a crucial feature of developing life. For others, only later points of neural development (where pain might plausibly be experienced) are held to be decisive.98 Critics meanwhile contend that neural development as well as development of other systems (such as the cardio-vascular system) are the natural outcome of the genetic program in action, and should be explained by reference to the previous stage and as leading to the subsequent stage, rather than marking a significant discontinuity.99 They maintain that the human being is, from the start, an inseparable psycho-physical unity, rather than a pure rationality or consciousness that exists with no meaningful ties to our bodies. From a scientific perspective, such critics hold, there is no meaningful moment when one can definitively designate the biological origins of a human characteristic such as consciousness, because our mind works in and through our body, and the roots of consciousness lie deep in our development. The earliest stages of human development serve as the indispensable and enduring foundations for the powers of freedom and self-awareness that reach their fullest expression in the adult form.100 Some of those who believe that neural development is crucial, however, argue that the fact of non-sentience and of an inability to experience pain possess great moral significance, quite apart from the question of probable potential.
(c) Human form: Some observers also argue that certain rudimentary features of the human form must be apparent before we can consider a human embryo deserving of protection. In this view, the human form truly signals the presence of a human life in the making and calls upon our moral sentiments to treat the being in question as “one of us.”101 Different versions of this argument appeal to different particular elements (or combinations of elements) of the human form as decisive, but all suggest that a “ball of cells” is not recognizably human and therefore ought not to be treated as simply one of us.102 Some critics of this view argue that humans have different external forms or shapes throughout their lives, and that an organism, particularly in its early stages, should not be judged by its external shape, but rather by its biological constitution, and especially its genetic identity.103 But adherents of the argument that human form matters contend that genetic identity cannot simply be decisive of moral worth.

These various particular cases for discontinuity (and these are not the only ones that have been propounded over the years) are not mutually exclusive. Indeed, many of them point to more than one particular element of early human development as finally decisive of moral standing. But they share the belief that moral status accrues only at some later stage of the developing human organism. Their claim, in the broadest terms, is that in its earliest stages a human embryo is not yet simply a human being or a human person, and that it need not be treated as though it were.104 Human development, they contend, is an essential element in any understanding of human life, and an organism at the earliest stages of that process is not to be treated the same as one much farther along.105 There are developmental differences, and these differences matter, in ways to be determined by human choice and understanding, as well as by a grasp of the biological facts.106

Critics of this view contend that while it is certainly true that human beings at different stages of development are not to be treated the same (as children are not given the responsibilities of adults), the crucial treatment here at issue is destructive treatment. No human being, at any stage, they argue, should simply be destroyed for research, and the “use” of an embryo for research, no matter how valuable one deems the research to be, could not amount to treatment of that embryo as “deserving some degree of respect.” The degree of respect granted in destroying the embryo would be zero, they contend.107

Nonetheless, the case for developing moral status, as articulated by a great number of participants in the policy debates of the past several years, often results in an expression of what has sometimes been termed the “special respect” approach to human embryos: an embryo in its earliest stages is not accorded the full moral standing of a human person, but it is nonetheless regarded as deserving some degree of respect and is treated as more than a mere object or collection of somatic cells in tissue culture. In practice, adherents of this view tend to accept the use of early human embryos in medically valuable research under some circumstances, but they seek to apply some scrutiny to the reasons for which embryos will be used, the circumstances under which those embryos are obtained, and other relevant factors. Several bodies advising the federal government on human embryo research over the years have expressed this view, to varying degrees. The Ethics Advisory Board to the Department of Health, Education and Welfare concluded in 1979 that the early human embryo deserves “profound respect” as a form of developing human life (though not necessarily “the full legal and moral rights attributed to persons”).108 The NIH Human Embryo Research Panel agreed in 1994 that “the preimplantation human embryo warrants serious moral consideration as a developing form of human life,” though the panel argued that this did not mean that research should be prohibited.109 In 1999, the National Bioethics Advisory Commission (NBAC) cited broad agreement in society that “human embryos deserve respect as a form of human life,”110 but, like its predecessors, did not recognize the embryo as having the full rights of a human person. The special respect position has been held by its advocates to be consistent with a range of possible particular policies on embryo research, including fairly restrictive ones, and indeed could be held consistent even with an outright restriction on the destruction of human embryos.v 111 To consider the embryo “inviolable” (and therefore not a mere utility to be instrumentally used), it is not necessary to presuppose its moral equality with a child, an adult or even a later stage gestating fetus. There may be increasing moral obligations (and natural sentiments) associated with a deepening relationality that extend moral duty without in any way implicitly eroding an imperative of protection at earlier stages of developing life. Most of those who have articulated the special respect position in the public debate have, however, tended to then argue that some research on embryos should be permitted within certain boundaries, even if they have not always agreed on the permissible extent or the appropriate boundaries.

B. Special Cases and Exceptions

Some arguments in favor of permitting and funding embryo research, grounded in the “special respect” approach, do not in fact explicitly (or exclusively) rely on arguments about discontinuity or a biologically grounded view of developing moral status. Instead, or in addition, they rely upon questions of embryo viability and potential, and they are aimed at exploring unique circumstances to address and perhaps resolve questions of the moral standing of certain particular human embryos.

1. IVF “Spares.”

Much of the debate surrounding embryonic stem cell research has focused on the use of cryogenically preserved IVF embryos, left over from assisted reproduction procedures and stored, perhaps indefinitely, in the freezers of IVF clinics. One recent study suggests there are hundreds of thousands of such embryos in the United States alone, though only a very small percentage of them (less than 3 percent, approximately 3,000 or more) has ever been donated for research.112 Although all were produced with reproductive intent and were stored for further reproductive efforts should the first attempt fail, most of these frozen embryos may never be claimed by the original egg and sperm donors for use in assisted reproduction procedures. They are almost certain to remain frozen and, eventually, to die without developing further. Although there have been some efforts to build interest in adopting such embryos, such adoption, some commentators argue, is very unlikely to become a large-scale phenomenon or to affect the fate of most of these stored embryos. 113 Under the present funding policy, if these frozen embryos were donated for research and embryonic stem cells were derived from them, research on the resulting cells would not be eligible for federal funding. Many observers argue that it should be: Since these particular embryos are almost certainly destined to die without ever developing, it would be appropriate to at least redeem some possible good from their existence and unavoidable demise.114

Some people have pushed the point further. Since the vast majority of the (huge number of) cryopreserved embryos will almost certainly not be adopted, and since many may not be viable even if they were to be transferred to a woman’s uterus, a few observers have argued that, practically speaking, the frozen embryos are virtually all already lost.115 To be sure, they are not already dead, but they are in a so-called “terminal situation” from which no rescue is practically possible. In view of this situation, one commentator proposes extending to these embryos the principle that sometimes, he argues, permits the killing of innocents. That is, killing may be morally permissible in cases where the person will soon die for other unavoidable reasons and where there is another person who can somehow be rescued through or as a result of such a normally impermissible act of killing (thus, as he puts it, “nothing more is lost”). He admits that the case of cryopreserved embryos stretches the application of the “nothing is lost” principle beyond its previous uses, because the embryos in question are alive and at risk of death only because of human choices and designs specifically directed toward them. The principle is also stretched because the lives that might someday be saved through today’s embryo deaths are quite remote. The potential lives saved are those of unspecified future persons with diseases that might be treated by therapies that as yet do not exist and may or may not exist in the future. However, against the weight of all these ifs, which some find formidable, there is the present fact that (like the embryos used to create stem cell lines derived before August 9th of 2001) the cryopreserved embryos are already here, with little or no prospect of rescue—they are, in this observer’s description, already lost.116

Presumably, if destruction of “spare embryos” for human embryonic stem cell research were generally agreed to be permissible through this “nothing is lost” principle, it could be federally funded, subject to such routine secondary considerations as the need for free and informed consent by donors.

Yet this argument, not surprisingly, has met with opposition. Some critics have claimed that it employs circular moral reasoning. The embryos, they argue, are in a “terminal situation” because of human choice and design; thus to then decide that, since they are going to die anyway, they may as well be put to good use is to ignore the moral implications of the original decision to create and freeze them. Critics argue, moreover, that when thinking about our responsibilities to those who are soon to die, we would normally say that it makes a considerable moral difference whether we simply accept their dying or whether we positively embrace it as our aim.117Yet some proponents of using IVF spares argue that the present situation is best understood as a forced choice between two regrettable alternatives for the final disposition of stored embryos (whether donated for research or abandoned). One choice may then be justified as the lesser evil. Even if one deems the original decisions leading to the creation and storage of these embryos questionable, the embryos exist, and the earlier decisions cannot be undone.118

Some have also worried about the possibility of a “slippery slope,” by which the uses of “spare” IVF embryos under this justification might open the door to their wider use in experiments in natural embryogenesis, toxicological studies or chimerizations, or perhaps their development in an artificial (or natural) endometrium,119 (though the reasonableness of “slippery slope” arguments is often disputed).120 Other critics point out that the “nothing is lost” principle is not permitted to govern decisions regarding lethal experiments on the terminally ill, on death-row inmates, or even on fetuses slated for abortion.121

A further issue involves the question of whether accepting the “nothing is lost” principle for already existing embryos condones in principle the use of future excess embryos, or whether the principle actually requires efforts to prevent the creation or storage of “excess” embryos in the future.122 Further, this application of the principle relates only to embryos originally created for the purpose of reproduction but not transferred to initiate a pregnancy. Should their use in research be accepted, however, it is not clear that it would be possible to differentiate between embryos created originally for reproduction and extra embryos created with an eye to research uses, since the process of producing them would be identical (though consideration of the extra risks involved for the woman egg donor could act as a counter against any large-scale embryo-creation-for-research).123

Other observers, however, begin from the presence of cryogenically preserved embryos but extend further the argument justifying their use in research. They argue that there is good reason to use embryos for research, not only because a situation some judge tragic already exists but because donating embryos is an act of beneficence and using them is a social obligation incurred by their gift.124 This approach would have us start by recognizing that, in the current situation, there is a set of embryos (in IVF clinics) none of which will ever enter a uterus, or even a (still hypothetical) artificial uterus.125 These embryos, in one commentator’s term, are “unenabled” and have no potential for full development. Since there is no possible way for such embryos to develop, there is no “possible person” to whom any “unenabled” embryo corresponds; therefore using them in research involves no loss of possible life.126

Critics of this approach argue that in effect it allows the moral standing of any given embryo to be decided simply by those responsible for it. Thus, whether a given embryo has moral standing depends only on whether it has a practical prospect of developing, as evidenced by whether it will be transferred to a uterus. But whether it enters a uterus depends on human choices, so the moral standing of a given embryo depends on human choices. If we choose to withhold essential enabling conditions for an embryo’s development, these critics argue, then that embryo will lack not moral standing but merely the opportunity to develop. Its intrinsic nature, including its own potential to develop (given needed conditions), has not changed.127

Nonetheless, in the view of a number of commentators, the fact that so many frozen embryos already exist (even if only a small percentage of them are donated for research) changes the balance of duties and respect owed to any single ex vivo embryo. Several observers have argued that the presence of these frozen embryos, with little or no chance of attaining birth, creates special circumstances in which the use of embryos in research (whether destroying them in the course of research or allowing them to die and subsequently using them)128 is independent of any final judgment regarding the moral standing or worth of the ordinary human embryo, as such.129

2. Natural Embryo Loss.

Some authors tie their moral arguments regarding the use of embryos in research to the fact of the high rate of embryo loss under natural conditions of sexual intercourse and unassisted reproduction. They argue that directed destruction of ex vivo embryos for the purpose of research would not result in greater embryonic loss than occurs in this natural process and would result in far greater benefits for humanity.130 The rate of natural embryo loss after conception in unassisted human reproduction (taking in losses both before and after implantation), though not accurately known, is thought to be high, some suggest as high as 80 percent.131 Moreover, the fact of natural loss is now fairly well known, so that persons who engage in unprotected intercourse, whether seeking to reproduce or not, are knowingly bringing about the conception of many embryos that will die. We generally do not regard this embryo loss as unacceptably tragic, and we do not engage in great efforts to avert it or to find ways to diminish it (beyond research to prevent miscarriage, for instance). For this reason, these commentators argue, using artificially created embryos for purposes of research would not destroy a greater portion of those embryos than ordinarily die in natural unassisted reproduction.132

Moreover, they suggest, the high rate of natural embryo loss should call into question the views of those who believe that early-stage human embryos merit equal treatment with human children and adults. If so many die in the natural course of things, why do we not treat natural procreation as a great fountain of tragedy and carnage? The natural rate of embryo loss, and most people’s failure to mourn its consequences, they suggest, should teach us something about the limited significance of human embryos in the earliest stages. One observer adds that the same logic should diminish our concerns about creating extra human embryos for research, as long as sufficient embryos are created for implantation to keep the chances of survival for any given embryo as good as the chances in natural reproduction.133 Another argues further that human embryonic stem cell research might actually raise the probability of longer survival for all humans, including embryonic ones, and is therefore a case of permissible taking of life, even on the assumption that the embryos are persons.134

Opponents of this view, however, have argued that natural deaths of embryos and the deaths caused by intentional efforts to destroy ex vivo embryos for research are not morally equivalent. There are many things that happen naturally that we are not therefore justified in doing deliberately. Indeed, the rate of natural loss of live-born human beings is 100 percent, but that does not justify their killing. And, they argue, even if one were permitted to analogize the deaths of frozen embryos in vitro to the embryonic wastage in vivo, in neither case were the embryos lost destined or created for anything other than their procreative end. In contrast, they argue, using embryos for research bears no relation to their natural direction or trajectory. Critics also argue that the character of our reaction to the natural embryonic death does not justify our practice of destructive embryo research. For they believe that a creature’s moral worth is not dependent on the emotional reaction of others to its death.135 The absence of moral sentiment does not imply an absence of moral obligation (nor a right of adverse intervention in a naturally developing human life). Moreover, critics contend, it is not clear how many of these “natural losses” were in fact failures of the fertilization process, so that there was never a unified, integrated organism in the first place, and thus never the loss of a human embryo. It is also unclear, they argue, how much of the supposedly “natural” loss rate is actually due to contingent and changeable factors, such as environmental pollution, pesticides, or endometrial problems, and so is not simply an unavoidable fact of embryonic existence.136

3. Prediction of Non-Viability of Embryos.

Some people, hoping to get around the moral dilemma of destroying even “unenabled” embryos, seek to identify a subset of embryos that might reasonably be regarded in advance as non-viable. One proposal has involved the possibility that cloned human embryos, created by somatic cell nuclear transfer, may prove to be non-viable or unable to develop beyond a certain point (biological evidence that this may be the case is presented by Rudolph Jaenisch in Appendix N) or may even, by their nature and origins, simply not constitute the equivalent of human embryos. If this turns out to be true, it is further argued, it might be possible to use them without arousing some of the ethical dilemmas that accompany the use of otherwise potentially viable human embryos.137 Others point to a possible sub-group of those embryos currently frozen in storage as potentially non-viable. Although those embryos are not yet dead and, if thawed, would still exhibit some cellular function, some would be unlikely to survive even were transfer attempted. Since IVF procedures usually produce more embryos than can be transferred at one time, goes the argument, the clinicians choose for transfer those among the available embryos that look “the best” and seem most likely to survive and develop—so that those that are frozen are those deemed less likely to develop. Moreover, by applying similar judgment to the unimplanted embryos, we might identify those that would be least likely to survive even under the most favorable circumstances. These embryos might then reasonably be regarded as non-viable and therefore available for research since their use will not disrupt a potential life.138

There has not been much direct reaction to this view in the ongoing ethical debates. Yet some observers have noted, in other contexts, that the techniques used to identify which IVF embryos are more or less likely to develop successfully—estimates based usually on visual assessment of the embryos—have never been proven effective or even tested to ascertain their validity.139 Moreover, some argue, the true viability of cloned human embryos or of cryogenically stored embryos could not be determined in advance without attempting to implant them.140

4. Creation of Non-Viable Embryo-Like Artifacts.

Others, seeking to bypass altogether the issue of viability, propose the possibility of creating a biological entity that cannot rightly be called a living organism, yet that has the generic organic powers necessary to produce embryonic stem cells. They suggest that somatic cell nuclear transfer, or a similar technique, could be used to create an entity that lacks, by design, the qualities and capabilities essential to be designated a human life in process. By intentional alteration of the somatic cell nuclear components or the cytoplasm of the oocyte into which they are transferred, researchers may be able to construct an “artifact” that is biologically (and morally) more akin to cells in tissue culture, but could still provide a source of functional human embryonic stem cells.141 Proponents of this innovation aim to shift the ethical debate from the question of whether or when a human embryo should be considered a human being to the question of which organized structures and potentials constitute the minimal criteria for considering an entity to be a human embryo.142

Absent all the essential elements (including a full complement of chromosomes, proper genetic sequence and chromatin configuration, and cytoplasmic structures and transcription factors), advocates of this proposal argue, there can be no integrated whole, no organism, and hence no human embryo. By technically constructing biological entities lacking these essential elements yet bearing the partial organic potential often found in failures of fertilization, they suggest it may be possible to procure embryonic stem cells without producing an organismal or embryonic entity that can meaningfully be designated a being with moral standing.143

Proponents argue that there is a natural biological precedent for such an entity lacking the qualities and characteristics of an organism yet capable of generating cells with the character of embryonic stem cells. Teratomas are germ cell tumors that generate all three germ layers as well as more advanced cells, tissues, and partial limb and organ primordia. Yet these chaotic, disorganized, and nonfunctional masses lack entirely the structure and dynamic character of an organism. Likewise, failures of fertilization due to abnormal complements or chromatin configurations (imprinting) of the chromosomes may still proceed along partial trajectories of organic growth without being meaningfully designated as organismal entities.

These natural examples of “partial generative potential” (described by some as ‘pseudo-embryos’), together with other observations of early embryonic process, have led to a diverse array of suggestions for ways that embryonic stem cells may be produced without raising the moral issues involved in the creation and destruction of human embryos. These suggestions include the use of aneuploidies, polyploidies, viable cells from embryos in arrested development, parthenotes, and chimeras of human nuclear material and animal oocytes. Each presents its own particular technical challenges and raises unique and unfamiliar moral considerations. The scientific prospects for such projects remain largely unexplored in humans, though some animal work has shown promise, and proponents argue that they are within the reach of current technology.144

The crucial principle in all such efforts, proponents argue, is the preemptive nature of the intervention: undertaken at a stage before the transition to organismal status. They contend that just as we have learned that neither genes, nor cells, nor even whole organs define the locus of human moral standing, in this era of developmental biology we will come to recognize that cells and tissues with “partial generative potential” may be used for medical benefit without a violation of human life or dignity. Moreover, they argue, the moral distinctions essential to discern and define the categories of organism, embryo, and human being will be critical to progress in scientific research involving embryonic stem cells, chimeras, and laboratory studies of fertilization and early embryogenesis. These advances in developmental biology, they contend, will depend on clarifying these categories and defining the moral boundaries in a way that at once defends human dignity while clearing the path for scientific progress.145

This proposal has drawn criticism on several fronts. First, critics suggest, it would require significant research to ensure that the procedure reliably produced the desired sort of “non-embryonic” entity yet also still yielded normal human embryonic stem cells, and such research might itself be morally problematic. Second, this proposal raises a series of further scientific and ethical questions, including those regarding the minimal degree of “partial generative potential” for an entity to be considered an organism, and for an entity to be considered a human embryo. They point further to the risk of creating entities that are so ambiguous as to leave their moral standing in serious doubt, at least for those people who believe that the early stages of human life have at least some moral worth. Finally, proposals to use human oocytes raise moral concern regarding the source of supply, in this case as in the larger arena of in vitro fertilization and experimentation.146

Although this approach has never been tested in humans, animal experiments suggest it has potential, and it has begun to play a part in the debates over the moral standing of human embryos and the permissibility of embryo research more generally.


V. Societal Significance and Public Responsibility

While the bulk of the public debate surrounding embryonic stem cell research has been directed to the question of the moral standing of human embryos, some commentators have raised a number of other crucial and serious concerns. They have argued that the debate suffers from focusing too narrowly on questions of the standing of human embryos, when other issues—including the duties and responsibilities of those who engage in embryonic stem cell research, the implications of such uses of nascent life for our society (rather than just for the embryos themselves), the significance of the public debate, and a series of other issues—also bear heavily on the subject, and may illuminate it in ways at least as significant.147

Some authors, including some who do not believe that human embryos should simply be treated as inviolable persons, have argued that the instrumentalization of human embryos—the seeds of the next generation—might tend to coarsen the sensibilities of our society toward future generations, and toward human life in general, quite apart from the effects on the embryos themselves.148 Others also argue that by setting down the path laid out by human embryonic stem cell research, we open the way for other, and more troubling, techniques and developments. Since human suffering and disease will never come to an end, they suggest, the resort to extreme and potentially exploitative methods is unlikely to find a logical stopping point. Today, they argue, scientists want to use only the earliest embryos; but what will happen when it turns out that later-stage embryos are even more valuable in developing treatments for disease?149

Critics of this view have generally argued that it fails to offer a sufficient ground for impeding the promise and potential of medical treatments that might result from embryonic stem cell work. These critics see medical research as a central moral duty, and they argue that a society that prevents such research undermines not only medical progress, but the moral progress of the community as a whole. While instrumentalization and moral coarsening are real worries, these critics argue, long-term fears of a “slippery slope” do not justify renouncing the potential of today’s research. Future difficulties, they say, can be faced if and when they arrive in earnest.150

Other observers have raised concerns related to the ethical and policy debate itself, rather than to the specifics of one technique or another, or of one funding policy or another. Some, for instance, have argued that what is needed in the human embryonic stem cell research debate is not only an exchange of views about the substantive issues (though that is surely crucial) but also some sense of the appropriate democratic process for deliberation and for establishing appropriate public policy on such a profoundly contentious matter. The embryonic stem cell debate, it is argued, offers a valuable opportunity to think through the ways in which the American polity debates the most contentious moral issues.151 Some even suggest that such matters should be removed from the political process altogether, and left in the hands of a regulatory body specifically charged with monitoring and decision-making authority.152

Other observers worry that the promise of embryonic stem cell research to bring swift or immediate cures to those who are now ailing has been oversold. They point out that, two decades ago, similar claims of rapid cures were made on behalf of fetal tissue transplantation research, but have not as yet been realized (though, of course, the danger of unfulfilled hope always looms over medical research). Such talk, some observers have argued, tends to raise false hopes, and thus does a genuine disservice to the sick and disabled.153 Worse, some regard it as cruel and immoral to exploit the hopes and fears of the desperately ill and their families, especially when—as several scientists in the field have remarked—it is not very likely that stem cell based remedies will be available for most people now suffering from the potentially targeted diseases. This moral concern is tied directly to the longstanding bioethical principle of truth-telling, which obliges physicians to inform their patients honestly about their condition and prognosis and encourages researchers to be truthful in their assessments of the potential for new treatments and cures, whether or not what they have to say is what patients and their loved ones want to hear. “It is misleading to suggest that stem cells will bring cures,” one writer observes, “particularly cures for patients now coping with the serious diseases the research targets.”154

A related concern, raised by some of the same commentators, involves what has been termed “the disproportionate emphasis on stem cell research in contemporary health politics.”155 The prominence of this debate in American politics, they argue, may tend to distract us from the fact that many Americans, and even more people elsewhere, lack very basic healthcare and have no access to those medical tools and techniques that already exist and that raise no profound controversy.156 The concern for justice, and for the proper setting of priorities, they argue, requires us to see this line of research in its proper perspective. Because federal resources for research are limited, decisions must be made about which areas should receive high (and low) priority, and decisions must be made about how much to devote to research and how much to devote to programs that provide proven health care to patients. These commentators suggest that this view does not mean that stem cell research should not be funded, but only that we must keep in mind that funds are also needed for many other approaches to fighting suffering and disease.157 Critics of this view, however, respond that an excessive preoccupation with existing health care needs can jeopardize new medical research and medical progress, and that today’s “basic medicine” was once experimental research.158

Meanwhile, others have argued that the debate has been too narrow in another way. Any federal policy, they suggest, must take note not only of the potential promise of embryonic stem cell science, but also possible alternatives to such research, alternatives less morally troubling to many Americans. Many opponents of public funding for human embryonic stem cell research, for instance, have argued that more attention should be paid, and more resources devoted, to adult stem cell research, which raises few of the moral difficulties present in the embryonic stem cell debates159 (though, for some, it still does raise a number of ethical difficulties).160 Such work, they contend, might even make embryonic stem cell research (or, at the very least, publicly funded embryonic stem cell research)161 unnecessary, if it proves sufficiently useful.vi

In response, however, others point out that adult stem cell research already receives about ten times the amount of federal funding apportioned to human embryonic stem cell research. Critics also argue that embryonic stem cells may possess unique advantages over adult stem cells, just as (in some circumstances) the opposite may be the case, and that therefore both avenues, as well as research using stem cells derived from fetal tissue, should be pursued simultaneously.162 And they contend that opponents of embryonic stem cell research have oversold the promise of adult stem cells so that the public might come to see embryonic stem cell research as unnecessary.163 In the next chapter, we examine some of the scientific facts regarding adult and embryonic stem cells, but in the context of the ethical and political debates, the distinctions between them have been quite important and prominent.

In these ways, the controversial possibility of scientific alternatives, as well as concerns about the health of American culture and democracy, the honesty of a political debate that touches on the hopes and fears of many who are suffering, and the bigger picture of health-care politics all impinge upon the question of federal funding of human embryonic stem cell research.


VI. Conclusion

Participants in the public debate surrounding human embryonic stem cell research and the administration’s funding policy have addressed themselves to many complicated and difficult ethical matters: the character of the moral question at issue; the nature, object, ethical assumptions, and premises of the policy itself; the vexing question of what is owed to the early human embryo; and a number of other related concerns. As we have seen, strong and powerfully argued views have been presented on various sides of each of these questions. For now, neither side to the debate seems close to fully persuading the other of the truth it thinks it sees. But the rich and growing ethical debates do suggest the possibility of progress toward greater understanding of the issues, and toward more informed public decisionmaking, as all parties to the deliberation appreciate better just what is at stake, not only for them or their opponents, but indeed for all of us.

 

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Footnotes

i. Only “the now,” created by an act of speaking, defines the difference between past and future (tenses and deeds).

ii. Lori Andrews detailed both these ongoing efforts and existing legislation in the states in her presentation at the Council’s July 2003 meeting and in the accompanying paper. (See Appendix E.)

iii. Readers may find it helpful to consult Notes on Early Human Development (Appendix A).

iv. Also, several traditional religious views of the embryo (among some Jews and some Muslims, for instance) have attributed humanity to the embryo only after a particular point in its development, for example the 40th day.

v. This is partly due to the fact that “special respect,” and “intermediate moral status,” are rather vague terms, and embrace a very wide range of degrees of “specialness” and “intermediacy.”

vi. In 1999, the National Bioethics Advisory Commission stated that, “In our judgment, the derivation of stem cells from embryos remaining following infertility treatments is justifiable only if no less morally problematic alternatives are available for advancing the research,” though the commission did not conclude that adult stem cells were sufficiently shown to offer such an alternative. (National Bioethics Advisory Commission, Ethical Issues in Human Stem Cell Research, Washington, D.C.: Government Printing Office, 1999, p. 53.)

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Endnotes


1. “Press Conference by President Bush and Italian Prime Minister Berlusconi,” as made available by the White House Press Office, July 23, 2001.

2. See, for instance, Weissman, I. L., “Stem Cells—Scientific, Medical and Political Issues,” New England Journal of Medicine 346(20): 1576-1579 (2002).

3. See, for instance, Green, R., “Determining Moral Status,” American Journal of Bioethics 2(1): 28-29 (2002).

4. See, for instance, Orr, R., “The Moral Status of the Embryonal Stem Cell: Inherent or Imputed?” American Journal of Bioethics 2(1): 57-59 (2002).

5. See, for instance, Doerflinger, R., “Ditching Religion and Reality,” American Journal of Bioethics 2(1): 31 (2002).

6. See, for instance, Latham, S., “Ethics and Politics,” American Journal of Bioethics 2(1): 46 (2002).

7. See, for instance, Marquis, D., “Stem cell research: The Failure of Bioethics,” Free Inquiry 22(1): Winter 2002.

8. See, for instance, the presentation of Richard Doerflinger before the Council on June 12, 2003. A transcript of that presentation is available on the Council website at www.bioethics.gov.

9. See, for instance, FitzGerald, K., “Questions Concerning the Current Stem Cell Debate,” American Journal of Bioethics 2(1): 50-51 (2002).

10. See, for instance, Haseltine, W., “Regenerative Medicine: A Future Healing Art,” Brookings Review, Winter 2003.

11. See, for instance, Stolberg, S., “Scientists Urge Bigger Supply of Stem Cells,” The New York Times, September 11, 2001, p. A1.

12. See, for instance, Perry, D., “Patients’ Voices: The Powerful Sound in the Stem Cell Debate,” Science 287: 5457, 1423; and the presentation of Irving Weissman before the Council on February 13, 2002, available on the Council website at www.bioethics.gov.

13. This point was taken up by the Council in its report Human Cloning and Human Dignity: An Ethical Inquiry (July 2002), Chapter 6, pp. 167-168.

14. One useful description of this approach to the issue is Zoloth, L., “Jordan’s Banks, A View from the First Years of Human Embryonic Stem Cell Research,” American Journal of Bioethics 2(1): 7 (2002).

15. Callahan, D., What Price Better Health: The Hazards of the Research Imperative. Los Angeles, CA.: University of California Press, 2003; also see Daniel Callahan’s presentation before the Council on July 24, 2003, available on the Council’s website at www.bioethics.gov.

16. FitzGerald, K., op. cit., pp. 50-51.

17. For examples, see Weiss, R., “Legal Barriers to Human Cloning May Not Hold Up,” The Washington Post, May 23, 2001.

18. See, for instance, Elias, P., “States, Feds May Clash over Cloning Rules,” Genomics and Genetics Weekly, April 12, 2002, p. 24.

19. This, for instance, was the line of reasoning of the American Bar Association when, in August of 2002, it issued a resolution supporting limited therapeutic research using cloned human embryos. The report of the ABA’s Section of Individual Rights and Responsibilities (available from the ABA) lays out the case.

20. See, for instance, Russo, E., “Policy Questions and Some Answers,” The Scientist, April 15, 2003.

21. R. Alta Charo, of the University of Wisconsin Law School, quoted in Coyle, M., “The Clone Zone,” The National Law Journal, May 15, 2002.

22. Alan Meisel of the University of Pittsburgh School of Law, quoted in Coyle, M., “The Clone Zone,” The National Law Journal, May 15, 2002.

23. Berkowitz, P., “The Meaning of Federal Funding,” a paper commissioned by the President’s Council on Bioethics and included as Appendix F of this report.

24. See: Maher v. Roe 432 U.S. 464 (1977); Harris v. McRae 448 U.S. 297 (1980); Rust v. Sullivan 500 U.S. 173 (1991).

25. Berkowitz, P., “The Meaning of Federal Funding,” a paper commissioned by the President’s Council on Bioethics, and included as Appendix F of this report. See also Khushf, G., and Best, R., “Stem Cells and the Man on the Moon: Should We Go There from Here?” American Journal of Bioethics 2(1): 38 (2002).

26. FitzGerald, K., op. cit., pp. 50-51.

27. Doerflinger, R., op. cit., p. 31.

28. Childress, J., “Federal Policy Toward Embryonic Stem cell research,” American Journal of Bioethics 2(1): 34 (2002).

29. Kahn, J., “Missing the mark on stem cells,” Bioethics Examiner 5:3, Fall 2001, p. 1.

30. Murray, T., “Hard Cell,” The American Prospect, September 24, 2001.

31. See, for instance, Lefkowitz, J., “The Facts on Stem Cells,” The Washington Post, October 30, 2003, p. A23; and Bush, G.W., “Stem Cell Science and the Preservation of Life,” The New York Times, August 12, 2001, p. D13.

32. “How many lines,” The Washington Post, August 31, 2001, p. A22.

33. Daley, G., “Cloning and Stem Cells—Handicapping the Political and Scientific Debates,” New England Journal of Medicine 349(3): 211-212 (2003).

34. Kennedy, D., “Stem Cells: Still Here, Still Waiting,” Science 300: 865 (2003).

35. See, for instance, Brickley, P., “Scientists Seek Passports to Freer Environments,” The Scientist 15:36 (2001).

36. See, for instance, Weissman, I., “Stem Cells—Scientific, Medical and Political Issues,” New England Journal of Medicine 346(20): 1578-1579 (2002).

37. See, for instance, Weise, E., “USA’s Stem Cell Scientists Fear a Research Brain-Drain,” USA Today, May 12, 2003, p. 6D.

38. Clark, J., “Squandering Our Technological Future,” The New York Times, August 30, 2001, p. A19. See also the presentation of Thomas Okarma, President and CEO of Geron Corporation, before the Council on September 4, 2003. The full transcript of Okarma’s presentation may be found on the Council’s website at www.bioethics.gov.

39. Robertson, J., “Crossing the Ethical Chasm: Embryo Status and Moral Complicity,” American Journal of Bioethics 2(1): 33 (2002).

40. See, for instance, Pizzo, P., “Remove Obstacles to Stem cell research,” San Jose Mercury-News, June 19, 2003; and Holden, C. and Vogel, G., “‘Show Us the Cells’ U.S. Researchers Say,” Science 297: 923 (2002).

41. The most notable discussion of safety concerns has been Dawson, L., et al., “Safety Issues in Cell-Based Intervention Trials” Fertility and Sterility 80: 5, 1077-1085, 2003. We must note, however, that the assessment of the subject presented in that article relies upon the assumption that “all of [the approved] lines were derived using mouse feeder layers.” (p. 1078). In his presentation before the Council on September 4, 2003, NIH Director Elias Zerhouni flatly contradicted this assertion, telling the Council that “there are at least those, which is about 16 lines, I believe, that have not been exposed to either mouse or human cell—human feeder cell lines.” (The transcript of Zerhouni’s presentation is available on the Council’s website at www.bioethics.gov.) Those eligible unexposed lines, however, are not presently among the lines available to researchers, and it cannot be known in advance if or when they might become available or whether they will prove useable. In addition, the FDA has stated that even in the case of those lines that were developed with mouse feeders, “FDA does not intend that the agency’s regulation of xenotransplantation will preclude the use of these hES cell lines.” (Food and Drug Administration, “Guidance for Industry - Source Animal, Product, Preclinical, and Clinical Issues Concerning Use of Xenotransplantation Products in Humans,” April 3, 2003.) FDA Commissioner Mark McClellan also made that clear in his presentation before the Council, available at the Council’s website.

42. Faden, et al., “Public Stem Cell Banks: Considerations of Justice in Stem Cell Research and Therapy” Hastings Center Report 33:6 (2003).

43. See, for instance, Capron, A., “Stem Cell Politics: The New Shape to the Road Ahead,” American Journal of Bioethics 2(1): 35-36 (2002).

44. Robertson, J., op. cit., pp. 33-34.

45. See, for instance, the testimony of HHS Secretary Tommy Thompson before the Senate Health, Education, Labor and Pensions Committee, September 5, 2001; and Lefkowitz, J., “The Facts on Stem Cells,” The Washington Post, October 30, 2003, p. A23.

46. Brownstein, R., “Bush Won’t Budge on Stem Cell Position, Health Secretary Says,” Los Angeles Times, August 13, 2001, p. A9.

47. This comment was made by Council Member Gilbert Meilaender in Council discussion on September 4, 2003. A transcript of that discussion is available on the Council’s website at www.bioethics.gov.

48. See, for instance, FitzGerald, K., op. cit., pp. 50-51.

49. Khushf, G., and Best, R., op. cit., p. 38.

50. See, for instance, the discussion of the Council in its September 4, 2003 meeting, particularly the argument elucidated by Council Member Michael Sandel. A transcript of that session is available on the Council website at www.bioethics.gov.

51. See, for instance, Stolberg, S., op. cit.

52. See, for instance, Robertson, J., “Ethics and Policy in Embryonic Stem cell research,” Kennedy Institute of Ethics Journal 9(2): 109-136 (1999); Spike, J. “Bush and Stem cell research: An Ethically Confused Policy,” American Journal of Bioethics 2(1): 46 (2003); and Capron, A., op. cit., p. 36.

53. The statement was made by bioethicist Glen McGee, in reference to the Clinton-era proposed NIH rules on funding, quoted in Spanogle, J., “Transforming Life,” The Baylor Line, Winter 2000, p. 30.

54. The remark was made by Bishop Joseph A. Fiorenza, President of the U.S. Conference of Catholic Bishops, in a news release (“Catholic Bishops Criticize Bush Policy on Embryo Research,” made available by the United States Conference of Catholic Bishops, August 9, 2001).

55. This argument arose in the course of Council discussion on September 4, 2003 (see particularly the comments of Council Members Michael Sandel and Charles Krauthammer in that discussion). A transcript of that session is available on the Council’s website at www.bioethics.gov.

56. Ibid., see particularly the comments of Council Members Mary Ann Glendon and Gilbert Meilaender in that discussion.

57. For these guidelines, see Appendix D.

58. Ibid., see particularly the comments of Council Member William Hurlbut in that discussion.

59. Some reasons to regard public funding of activities in a light different from mere permission are proposed in Khushf, G., and Best, R., op. cit., p. 38.

60. “Remarks by the President on Stem Cell Research,” as made available by the White House Press Office, August 9, 2001.
 
61. “President’s Phone Call to March for Life Participants,” as made available by the White House Press Office, January 22, 2002.

62. See Council discussion on September 4, 2003, especially comments by Council Members Charles Krauthammer, Francis Fukuyama, Gilbert Meilaender, and Leon Kass. A transcript of that session is available on the Council’s website at www.bioethics.gov.

63. Bush, G.W., “Stem Cell Science and the Preservation of Life,” The New York Times, August 12, 2001, p. D13.
 
64. “Remarks by the President on Stem Cell Research,” as made available by the White House Press Office, August 9, 2001.
 
65. See, for instance, Council discussion on September 4, 2003 (particularly the comments of Council member Michael Sandel and invited guest Peter Berkowitz in that discussion). A transcript of that session is available on the Council’s website at www.bioethics.gov.
 
66. “Remarks by the President on Stem Cell Research,” as made available by the White House Press Office, August 9, 2001.
 
67. See, for instance, Council discussion on September 4, 2003 (particularly the comments of Council Members Charles Krauthammer and James Wilson in that discussion). A transcript of that session is available on the Council’s website at www.bioethics.gov.
 
68. For instance, in discussing research on cloned human embryos, President Bush said, “Research cloning would contradict the most fundamental principle of medical ethics, that no human life should be exploited or extinguished for the benefit of another. Yet a law permitting research cloning, while forbidding the birth of a cloned child, would require the destruction of nascent human life.” (“Remarks by the President on Human Cloning Legislation,” as made available by the White House Press Office, April 10, 2002); and in explaining his stem cell funding policy, the President wrote: “While it is unethical to end life in medical research, it is ethical to benefit from research where life and death decisions have already been made.” (Bush, G.W., “Stem Cell Science and the Preservation of Life,” The New York Times, August 12, 2001, p. D13.)

69. As noted previously, in August of 2001 Health and Human Services Secretary Tommy Thompson told reporters that “neither unexpected scientific breakthroughs nor unanticipated research problems would cause Bush to reconsider.” (See, Brownstein, R., “Bush Won’t Budge on Stem Cell Position, Health Secretary Says,” Los Angeles Times, August 13, 2001, p. A9).
 
70. One useful account of these issues is Cohen, E., “Of Embryos and Empire,” The New Atlantis 2: 3-16 (2003).

71. See, for instance, London, A., “Embryos, Stem Cells, and the ‘Strategic’ Element of Public Moral Reasoning,” American Journal of Bioethics 2(1): 56 (2002).

72. For examples of this way of proceeding—both in arguments supporting embryo research, and arguments opposing it—see, among numerous other sources, the Council’s July 2002 report, Human Cloning and Human Dignity: An Ethical Inquiry, Chapter 6.

73. See, for instance, McCartney, J., “Embryonic Stem cell research and Respect for Human Life: Philosophical and Legal Reflections,” Albany Law Review 65: 597-624 (2002).

74. See, for instance, Orr, R., op. cit., pp. 57-58.

75. See, for instance, Steinberg, D., “Can Moral Worthiness Be Seen Using a Microscope?” American Journal of Bioethics 2(1): 49 (2002).

76. See, for instance, Green, R., op. cit., p. 20.

77. See, for instance, Doerflinger, R., op. cit., pp. 31-33; Orr, R., op. cit., pp. 57-58; and the personal statements of Council Members William Hurlbut and Robert George and Alfonso Gómez-Lobo, in the Council’s July 2002 report Human Cloning and Human Dignity: An Ethical Inquiry, among others.

78. See, for instance, Orr, R., op. cit., pp. 57-58.

79. See, for instance, the personal statement of Council Member William Hurlbut, in the Council’s July 2002 report Human Cloning and Human Dignity: An Ethical Inquiry.

80. See, for instance, Sullivan, D., “The Conception View of Personhood: A Review,” Ethics and Medicine 19(1): 11-33 (Spring 2003).

81. A form of this argument was presented by some Members of the Council in the Council’s July, 2002 report Human Cloning and Human Dignity: An Ethical Inquiry, chapter 6, and in several of the personal statements appended to that report.

82. See, for instance, Steinberg, D., op. cit., p. 49.

83. See, for instance, the transcript of Council discussion on October 17, 2003, especially the comments of Council Member Elizabeth Blackburn. The full transcript is available on the Council’s website at www.bioethics.gov. Also see Green, R., op. cit., pp. 20-30.

84. See, for instance, Lanza, R., et al., “The Ethical Validity of Using Nuclear Transfer in Human Transplantation,” Journal of the American Medical Association, 284(24): 3175-3179 (2000). Also, see the views expressed by some Members of this Council in our July 2002 report Human Cloning and Human Dignity: An Ethical Inquiry, chapter 6, and in the personal statements of Council Members Elizabeth Blackburn, Michael Gazzaniga, and Janet Rowley.

85. See, for instance, the transcript of Council discussion on April 25, 2002, especially the comments of Council Member Daniel Foster. The full transcript is available on the Council’s website at www.bioethics.gov.

86. See, for instance, the position articulated in “Position Number Two” of the “Moral Case for Cloning for Biomedical Research” presented by some Members of the Council in the Council’s July, 2002 report Human Cloning and Human Dignity: An Ethical Inquiry, Chapter 6; and the personal statement of Council Member Michael Gazzaniga, appended to that report.

87. See, for instance, the comments of Council Member Michael Gazzaniga (and response from other Members) during Council discussion on February 14, 2002. The full transcript is available on the Council’s website at www.bioethics.gov.

88. See, for instance, Orr, R., op. cit., pp. 57-59; Callahan, S., “Zygotes and Blastocysts: Human enough to protect,” Commonweal, June 14, 2002; the position articulated by several Members of this Council in our July 2002 report Human Cloning and Human Dignity: An Ethical Inquiry, Chapter 6; and the personal statements of Council Members Robert George and Alfonso Gómez-Lobo, and William Hurlbut in that same report.

89. See, for instance, Steinberg, D., op. cit., pp. 49-50; and Green, R., op. cit., p. 20.

90. See, for instance, Meyer, M. J., and Nelson, L. J., “Respecting What We Destroy: Reflections on Human Embryo Research,” Hastings Center Report 31(1): 16-23 (2001).

91. See, for instance, Strong, C., “The Moral Status of Preembryos, Embryos, Fetuses, and Infants,” The Journal of Medicine and Philosophy 22(5): 457-478 (1997).

92. Pearson, H., “Your Destiny, from Day One,” Nature 418: 14-15 (2002).

93. See, for instance, McCartney, J., op. cit., pp. 601-602; Brogaard, B., “The moral status of the human embryo: the twinning argument,” Free Inquiry Winter 2002; Meyer, M. J., op. cit., p. 18. The question of twinning—pro and con—was also taken up by the Council in its July 2002 report, Human Cloning and Human Dignity: An Ethical Inquiry, Chapter 6.

94. See, for instance, Green , R., op. cit., pp. 21-22; Lanza, R., op. cit., p. 3177.

95. See, for instance, Ashley, B., and Moraczewski, A., “Cloning, Aquinas, and the Embryonic Person,” National Catholic Bioethics Quarterly 1(2): 189-201 (2001); Orr, R., op. cit., p. 58; Marquis, D., op. cit.; and Lori Andrews quoted in Green, R., op. cit., p. 22. The question of twinning—pro and con—was also taken up by the Council in its July 2002 report, Human Cloning and Human Dignity: An Ethical Inquiry, Chapter 6, and in the personal statement of Council Member William Hurlbut, attached to that report.

96. See, for instance, National Bioethics Advisory Commission, Ethical Issues in Human Stem cell research, Washington, D.C.: Government Printing Office, 1999, p. 7; and the position articulated by several Members of this Council in our July 2002 report Human Cloning and Human Dignity: An Ethical Inquiry, Chapter 6, among many others.

97. See, for instance, Lanza, R., op. cit., p. 3177.

98. See, for instance, Strong, C., op. cit., p. 467.

99. See, for instance, the views expressed by some Members of this Council in our July 2002 report Human Cloning and Human Dignity: An Ethical Inquiry, Chapter 6, and in the personal statement of Council Members Robert George and Alfonso Gómez-Lobo.

100. See, for instance, the personal statement of Council Member William Hurlbut, in the Council’s July 2002 report Human Cloning and Human Dignity: An Ethical Inquiry.

101. See, for instance, Wilson, J., “On Abortion,” Commentary January 1994; and the position articulated by several Members of this Council in our July 2002 report Human Cloning and Human Dignity: An Ethical Inquiry, Chapter 6.

102. See, for instance, Green, R., op. cit., pp. 20-30; and the position articulated by several Members of this Council in our July 2002 report Human Cloning and Human Dignity: An Ethical Inquiry, Chapter 6.

103. See, for instance, the views expressed by some Members of this Council in our July 2002 report Human Cloning and Human Dignity: An Ethical Inquiry, Chapter 6, and in the personal statement of Council Members Robert George and Alfonso Gómez-Lobo.

104. See, for instance, National Institutes of Health, Report of the Human Embryo Research Panel, Bethesda, MD.: NIH, 1994; and the position articulated by several Members of this Council in our July 2002 report Human Cloning and Human Dignity: An Ethical Inquiry, Chapter 6.

105. See, for instance, McGee, G., “The Idolatry of Absolutizing in the Stem Cell Debate,” American Journal of Bioethics 2(1): 53-54 (2002).

106. See, for instance, Green, R., op. cit., p. 20.

107. See, for instance, the views expressed by some Members of this Council in our July 2002 report Human Cloning and Human Dignity: An Ethical Inquiry, Chapter 6, and in the personal statements of Council Members Gilbert Meilaender, William Hurlbut, Robert George and Alfonso Gómez-Lobo.

108. “Report of the Ethics Advisory Board,” 44 Fed. Reg. 35,033-35,058 (June 18, 1979) at 35,056.

109. NIH, op. cit., Report of the Human Embryo Research Panel, p. 2.

110. National Bioethics Advisory Commission (NBAC), Ethical Issues in Human Stem Cell Research Bethesda, MD.: Vol. I, p. ii; cf. p. 2 (September 1999).

111. See, for instance, Lebacqz, K., “On the Elusive Nature of Respect,” in Holland, S., Lebacqz K., and Zoloth, L., eds., The Human Embryonic Stem Cell Debate, Cambridge, MA.: MIT Press, 2001, pp. 149-162; and the personal statement of Council Member Rebecca Dresser, appended to the Council’s July 2002 report Human Cloning and Human Dignity: An Ethical Inquiry.

112. Hoffman, D.I., et al., “Cryopreserved Embryos in the United States and Their Availability for Research,” Fertility and Sterility 79: 1063-1069 (2003).

113. See, for instance, Spike, J., op. cit., p. 45.

114. See, for instance, the testimony of Michael West before the Labor, HHS, and Education Subcommittee of the Senate Appropriations Committee, December 4, 2001, among others.

115. Outka, G., “The Ethics of Stem cell research,” a paper presented to the Council for its April 2002 meeting, and available on the Council website at www.bioethics.gov. A slightly revised version appeared in the Kennedy Institute of Ethics Journal, 12:2, pp. 175-213.

116. Ibid.

117. See, for instance, “The Stem Cell Sell,” Commonweal, August 17, 2001; Meilaender, G., “Spare Embryos,” The Weekly Standardl, August 26, 2002; and Council discussion of Gene Outka’s paper, in its April 2002 meeting, a transcript of which is available on the Council website at www.bioethics.gov.

118. See, for instance, McCartney, J, op. cit., p. 615.

119. Council Member William Hurlbut, in Council communication.

120. See, for instance, the comments of Council Member James Wilson during Council discussion on April 25, 2002. The full transcript is available on the Council’s website at www.bioethics.gov.

121. A federal law, 42 U.S.C. § 289, is directed specifically against any such lethal experimentation on these populations.

122. This concern is raised in Outka, G., “The Ethics of Stem Cell Research,” a paper presented to the Council for its April 2002 meeting, and available on the Council website at www.bioethics.gov. Also see the Council discussion of that paper, available on the Council website; and see Meilaender, G., op. cit.

123. See, for instance, the transcript of Council discussion on April 25, 2002, available on the Council’s website at www.bioethics.gov.

124. Guenin, L. M., “Morals and Primordials,” Science 292: 1659-1660 (2001).

125. Spike, J., op. cit., p. 45.

126. Guenin, L., op. cit.

127. See, for instance, Orr, R., op. cit., p. 58.

128. Mahowald, M. and Mahowald A., “Embryonic Stem Cell Retrieval and a Possible Ethical Bypass,” American Journal of Bioethics 2(1): 42-43 (2002).

129. See, for instance, Zoloth, L., op. cit., pp. 4-5.

130. See, for instance, Harris, J., “The ethical use of human embryonic stem cells in research and therapy,” in Burley, J. and Harris, J., eds., A Companion to Genetics: Philosophy and the Genetic Revolution, Oxford: Basil Blackwell, 2001; and Savulescu, J., “The Embryonic Stem Cell Lottery and the Cannibalization of Human Beings,” Bioethics 16(6): 508-529 (2002).

131. This subject was discussed in a Council session on January 16, 2003. When asked, in the course of a presentation before the Council, about the rate of natural embryo loss, Dr. John Opitz (Professor of Pediatrics, Human Genetics, and Obstetrics/Gynecology, School of Medicine, University of Utah) responded: “Estimates range all the way from 60 percent to 80 percent of the very earliest stages, cleavage stages, for example, that are lost.” The transcript of this session is available on the Council website at www.bioethics.gov.

132. Spike, J., op. cit., p. 45.

133. Harris, J., “Stem Cells, Sex & Procreation,” a paper presented to the American Philosophical Society, March 29, 2003.

134. Savulescu, J., op. cit., pp. 508-529.

135. See, for instance, Orr, R., op. cit., pp. 57-59.

136. See, for instance, Council discussion in its January 2003 meeting, a transcript of which is available on the Council website at www.bioethics.gov.

137. See, for instance, the comments of Rudolph Jaenisch before the Council in its July 2003 meeting, and Dr. Jaenisch’s accompanying paper (included in Appendix N of this report). See also the personal statement of Council Member Paul McHugh, appended to the Council’s July 2002 report Human Cloning and Human Dignity: An Ethical Inquiry.

138. See, for instance, Zoloth, L., op. cit., pp. 4-5.

139. See, for instance, Mandavilli, A., “Fertility’s New Frontier Takes Shape in the Test Tube,” Nature Medicine 9: 1095 (2003).

140. See, for instance, Council discussion with Rudolph Jaenisch at the Council’s July 2003 meeting, and discussion taken up in the Council’s July 2002 report Human Cloning and Human Dignity: An Ethical Inquiry, Chapter 6.

141. See, for instance, the personal statement of Council Member William Hurlbut, in the Council’s July 2002 report Human Cloning and Human Dignity: An Ethical Inquiry; the transcripts of Council discussions on June 20, 2002 and July 24, 2003, available on the Council’s website at www.bioethics.gov; and Weiss, R., “Can Scientists Bypass Stem Cells’ Moral Minefield?” The Washington Post, December 14, 1998, p. A3.

142. See, for instance, the transcript of Council discussion on July 24, 2003, available on the Council’s website at www.bioethics.gov.

143. See, for instance, the transcript of Council discussion on June 20, 2002, available on the Council’s website at www.bioethics.gov.

144. See remarks by Professor Rudolph Jaenisch before the Council’s July 24, 2003 meeting. A transcript of that session is available on the Council’s website at www.bioethics.gov.

145. See, for instance, the personal statement of Council Member William Hurlbut, in the Council’s July 2002 report Human Cloning and Human Dignity: An Ethical Inquiry.

146. See, for instance, a number of arguments raised in Weiss, R., “Can Scientists Bypass Stem Cells’ Moral Minefield?” The Washington Post, December 14, 1998, p. A3; and the transcript of Council discussion on June 20, 2002, available on the Council’s website at www.bioethics.gov.

147. Lauritzen, P., “Report on the Ethics of Stem cell research,” a commissioned paper prepared at the request of the Council and included in Appendix G of this report. See also the Council’s July 2002 report Human Cloning and Human Dignity: An Ethical Inquiry, Chapter 6.

148. See, for instance, Kass, L., “The Meaning of Life - In the Laboratory,” The Public Interest, Winter 2002. Also see the Council’s July 2002 report Human Cloning and Human Dignity: An Ethical Inquiry, Chapter 6.

149. This case is articulated by several Members of the Council in the Council’s July 2002 report Human Cloning and Human Dignity: An Ethical Inquiry, Chapter 6. See also, “Biotechnology: A House Divided,” The Public Interest, Winter 2003.

150. This case is articulated, for instance, by several Members of the Council in the Council’s July 2002 report Human Cloning and Human Dignity: An Ethical Inquiry, Chapter 6.

151. Strong, C., “Those Divisive Stem Cells: Dealing with Our Most Contentious Issues,” American Journal of Bioethics 2(1): 39-40 (2002).

152. See, for instance, the Council’s July 2002 report Human Cloning and Human Dignity: An Ethical Inquiry, Chapters 6 and 8, available on the Council’s website at www.bioethics.gov.

153. See, for instance, Dresser, R., “Embryonic Stem Cells: Expanding the Analysis,” American Journal of Bioethics 2(1): 40-41 (2002); and FitzGerald, K., op. cit., pp. 50-51.

154. Dresser, R., op. cit., p. 41.

155. Ibid.

156. See also FitzGerald, K., op. cit., pp. 50-51.

157. Dresser, R., op. cit., p. 41.

158. See, for example, the discussion and presentations at the Council’s July 2003 meeting, available on the Council’s website at www.bioethics.gov.

159. See, for instance, Orr, R., op. cit., pp. 57-58; “A review of the National Institute of Health’s Guidelines for Research Using Human Pluripotent Stem Cells,” Issues in Law and Medicine 3(17): 293; and the testimony of Representative David Weldon before the Technology and Space Subcommittee of the Senate Commerce, Science and Transportation Committee, January 29, 2003.

160. Lauritzen, P., “Report on the Ethics of Stem cell research,” a commissioned paper prepared at the request of the Council and included in Appendix G of this report.

161. See, for instance, Oldham, R., “Stem Cells: Private Sector Can Do It Better,” The Wall Street Journal, August 28, 2001, p. A14.

162. See, for example, the discussion and presentations at the Council’s April 2002 meeting, available on the Council’s website at www.bioethics.gov; and Verfaillie, C., “Multipotent Adult Progenitor Cells: An Update,” a commissioned paper prepared at the request of the Council and included in Appendix J of this report.

163. See, for example, the discussion and presentations at the Council’s July 2003 meeting, available on the Council’s website at www.bioethics.gov.

 

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