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Public Policy Regarding Human Embryo Research

 

Testimony of Richard M. Doerflinger on behalf of the U.S. Conference of Catholic Bishops before the President's Council on Bioethics

June 12, 2003

Subject: Embryo Research and Related Issues

I am Richard M. Doerflinger, Deputy Director of the Secretariat for Pro-Life Activities at the U.S. Conference of Catholic Bishops. On behalf of the bishops' conference I want to thank this Council for asking us to present our views on public policy regarding human embryo research.

We have been asked to address the question: What values and principles currently do (and which ideally should) guide the regulation of embryo research and related activities in the United States?

In our view, a substantial (though not unanimous) consensus has long existed in support of certain key values and principles that are relevant to this issue. Tragically, however, these values and principles -- and even key facts -- have sometimes been acknowledged, only to be obscured or neglected when the time came to use them as a basis for public policies. The result has been an inconsistent patchwork of laws and regulations through which these values can sometimes be perceived only with difficulty.

What follows, then, will not emphasize values that are specifically Catholic or those which are understandable only to religious believers. Rather, it will focus on general values that are found in the natural law tradition of moral reflection, and have also found expression in secular documents and reports as well as longstanding legal enactments. An appropriate and helpful role for a government bioethics council, in our view, is to elicit these core values from enactments that have gone before and work to ensure that they are more consciously and consistently put into practice in the future.

1. Ethical norms should not be traded for medical benefits

The first and most important ethical value at stake in this discussion is simply the inescapable need for ethical limits themselves. A research enterprise driven simply by a utilitarian calculus, dedicated to the principle that "the end justifies the means," is best seen not as an exercise in one approach to ethics but as a threat to any ethic worthy of the name.

The temptation to engage in unethical exploitation of humans for medical research is as old as modern medicine. As soon as Western thinkers began to see medicine as a science that could advance and acquire new knowledge, the temptation arose of using human beings as mere means to this end.

When Dr. Claude Bernard sounded an alarm against this temptation, in the 19th century, the preferred victims were prisoners convicted of serious crimes. He insisted that the physician must not deliberately do harm to any of his neighbors simply to acquire knowledge that may help others:

The principle of medical and surgical morality, therefore, consists in never performing on man an experiment that might be harmful to him to any extent, even though the result might be highly advantageous to science, i.e., to the health of others. But performing experiments and operations exclusively from the point of view of the patient's own advantage does not prevent their turning out profitably to science.1

Here, in 1865, Dr. Bernard was already making the important distinction between therapeutic and nontherapeutic experimentation. The fact that an experiment may benefit the research subject is only one moral requirement among others; but it is one thing to provide a human being with an experimental treatment whose outcome may also help in treating others in the future, and quite another thing simply to use the human subject as a means, imposing significant risks on him or her solely to benefit others.

In the Nuremberg Code, the United States and its allies responded to the horrors of the Nazi war crimes by restating this principle, to ensure that human dignity would not again be trampled upon in the pursuit of medical knowledge. The code's key norms could be summed up as follows:

First, no unnecessary risk to human subjects. The knowledge gained must be important for the good of society and "unprocurable by other methods or means of study," and the study must be preceded by animal studies and other precautions to minimize any risk to humans.

Second, "the voluntary consent of the human subject is absolutely essential." This must be an informed consent -- the research subject must understand the nature and purpose of the experiment and its possible risks before consenting to participate.

Third, one must never cause serious injury or death in the name of medical knowledge. "No experiment should be conducted where there is an a priori reason to believe that death or disabling injury will occur..."2

This code was the inspiration for many later declarations, including the "Declaration of Helsinki" first approved by the World Medical Association in 1964. Here the key principle is:

In medical research on human subjects, considerations related to the well-being of the human subject should take precedence over the interests of science and society.

The Helsinki declaration noted that this principle must apply to all human beings, and that "some research populations," including those who cannot give consent for themselves, "need special protection."3 It seems this principle was intended to extend to the unborn. The World Medical Association's parallel statement on the ethics of the practicing physician, the "Declaration of Geneva," provided an oath by which the physician swears: "I will maintain the utmost respect for human life, from the time of conception."4

Despite these solemn declarations, the utilitarian approach to research ethics has become popular among scientists and others who want to justify harmful experiments on human embryos today. When asked in 1994 whether the National Institutes of Health's Human Embryo Research Panel should base its conclusions on the principle that "the end justifies the means," the Panel's chief ethicist quoted the man known as the father of situation ethics, Joseph Fletcher: "If the end doesn't justify the means, what does?"5 He did not mention that Fletcher in turn claimed to be quoting Nikolai Lenin, who reportedly used it to justify the killing of countless men, women and children in the Russian revolution of 1917.6 History has provided us with little reason to favor utilitarian thinking about human life -- for even judged by its own terms, making moral judgments solely on the basis of consequences has so often had terrible consequences.

In the deliberations of this Council, it has sometimes been said that providing medical benefits and maintaining ethical norms against the misuse of research subjects are both important values to be balanced against each other – with some participants giving more weight to one, and some giving more weight to the other. However, this analysis of the issue is misleading.

The positive obligation to promote benefits for suffering patients, through medical research and other means, is important and generally valid.7 However, it is a general norm that can be pursued in many different times and circumstances and in many ways, and it has no upper limit – that is, it will always be true during our earthly life that more could be done to promote this human good. The negative norm that one should not harm or exploit human life in the service of such positive goals is equally demanding, but can only be pursued in one way: by refusing to violate the norm. These values are not in conflict, much less capable of being "balanced" against each other, because they are not commensurable. One cannot ethically kill one innocent human being on the grounds that this may produce results that could save the lives of several human beings. Rather, the negative norm sets a lower limit for ethically acceptable research – it requires us to pursue our positive goals in ways that will not violate the negative norm.8

When the NIH Human Embryo Research Panel proposed federal funding of human embryo research in 1994, it based its conclusions on exactly the opposite approach. It dissolved any possible tension between the negative norm against harming research subjects and the positive norm to advance medical progress, by subordinating the former entirely to the latter. Its ethical analysis cited an article by the Panel's ethics co-chair, Prof. Ronald Green of Dartmouth, in which he argued that there are no realities "out there" in human beings that require us to respect anyone as a person. It is the task of the educated and articulate members of society, he wrote, to decide which qualities in others are morally relevant, based on their own enlightened self-interest. If we deny "personhood" or moral worth to too many people, we may risk denying it to ourselves or others we care about; if we bestow it on too many people, we may be depriving ourselves and our loved ones of the benefits of lethal human experimentation on those people.9

Professor Green called this deconstructionist approach to human dignity a "Copernican revolution" in medical ethics. It is exactly the opposite. Copernicus, a devout Catholic, no doubt felt he was striking a blow against human presumption by showing that we are not at the center of our physical universe. The NIH panel's ethical revolution revived human presumption, by denying any objective reality in human beings that could limit our ability to choose to treat them as means to our ends. In this approach, if respecting a particular kind of human subject would prevent us from pursuing particularly promising research, that is a sufficient reason for refusing to respect that individual. This is to turn the Nuremberg Code upside down.

Researchers and those eager to be helpful to their enterprise are, and always have been, impatient with such intractable limits. That is one reason why society cannot allow the research community itself to be the sole arbiter of research ethics.

The risks of allowing the research community to set the policy agenda can be seen in several states where bills on stem cell research were recently introduced with the support of state biotechnology alliances. These bills are designed to authorize the use of embryonic, fetal or even (in some cases) adult stem cells derived from human cloning (somatic cell nuclear transfer). No member of this Council has ever expressed support for such an extreme policy, which seems to envision the "farming" of fetal and even newborn humans as sources of tissues and organs.10

Taking the bill proposed in Maryland (which was defeated in committee) as an example, two declarations in the bill's findings are especially noteworthy.

The first declaration is this: "The United States and the State of Maryland have historically fostered open scientific inquiry." The truth is that our federal and state governments have insisted that scientific inquiry not be pursued if it will mistreat human subjects. Granted that historically there have been lapses in which the desire for medical progress was allowed to outweigh ethical concerns, these are generally recognized as the darkest pages of our nation's medical history. Maryland, in fact, has been in the forefront of states insisting on clear ethical and legal limits to medical research, and its courts have found that researchers can be sued for negligence when they give insufficient attention to the safety and well-being of children who are too young to consent to research. In Grimes v. Kennedy Krieger Institute, 782 A.2d 807 (Md. 2001), Maryland's highest court found that the IRB at Johns Hopkins University had "abdicated" its responsibility to protect children from research risks, and had shown that it "was willing to aid researchers in getting around federal regulations designed to protect children used as subjects in nontherapeutic research." Id. at 813-14. Researchers at Johns Hopkins University nonetheless testified in support of the new cloning bill this year, citing the State of Maryland's support for open scientific inquiry.

The second and closely related declaration in the Maryland bill was that "public policy on stem cell research must balance ethical and medical considerations." This statement sounds moderate, until one realizes what a departure it is from Nuremberg's and Helsinki's insistence that the lure of medical progress must never outweigh ethics.

Researchers must be warned not to "balance" ethics and medicine, for that would mean one can pursue even research that one knows is unethical -- if the potential medical benefit is great enough. The researchers who conducted the Tuskegee syphilis experiment on African-American men, those who deliberately infected retarded children with the hepatitis virus at the Willowbrook home, those who approved the Cold War radiation experiments on unsuspecting American civilians, those who allowed children to be exposed to lead poisoning in the research condemned by the Maryland Court of Appeals -- these researchers "balanced" ethics and progress, and progress won. We urge this Council not to pursue such "balance," but instead to take to heart the warning expressed by a survivor of Dr. Josef Mengele's notorious "identical twin" experiments: "Human dignity and human life are more important than any advance in science or medicine."11

2. Respect for the human embryo as a developing human life.

To some, the principle that the human embryo is among the human beings who deserve protection from research risks may not seem a consensus value. Yet four major advisory groups recommending federal policies on human embryo research over the past 23 years have agreed on this principle – or claimed to agree on it. For example, 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").12 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."13 In 1999, the National Bioethics Advisory Commission (NBAC) cited broad agreement in our society that "human embryos deserve respect as a form of human life."14 And in 2002, a committee of the National Academy of Sciences acknowledged that "from fertilization" the embryo is "a developing human."15

None of these bodies could be described as having been appointed with any input from pro-life groups. The EAB was appointed under President Carter, the NIH panel and NBAC under President Clinton, and the NAS panel, of course, by NAS's leadership. Moreover, all these bodies wanted to authorize at least some research involving destruction of human embryos – in the case of the NIH panel, it was publicly announced at the outset that approval of embryo research was its mandate, and that anyone who objected to such research on moral grounds was ineligible to serve on it.16 These bodies all nonetheless conceded that the subject of embryo research is a developing human life, because this fits best with the evidence. (See the Appendix for an overview of the biological evidence on the status of the human embryo.).

While it makes no sense to say that any of us was once a body cell, or a sperm, or an egg, it makes all the sense in the world to say that each of us was once an embryo. For the embryo is the first stage of my life history, the beginning of my continuous development as a human organism. This claim makes the same kind of sense as the claim that I was once a newborn, although I do not have any recollection of cognitive or specifically human "experiences" during that stage of life.

This is distinct from the question whether the embryo has the moral status of a person. However, one need not make claims about personhood to understand a moral obligation to respect and protect developing human life. Without making such claims, for example, federal regulations since 1975 have treated the human embryo in the womb (from the time of implantation onward) as a human subject to be protected from research risks. Moreover, by secular reasoning one can make a strong case in favor of treating every fellow member of the human species as a person. Indeed, any other standard – assigning personhood on the basis of appearance, cognitive ability, etc. – will exclude many more people from personhood than just the embryo. This is readily apparent from the writings of ethicists who have started out to justify early abortion, and have found themselves unable or unwilling to make an absolute or principled case against infanticide or euthanasia.

The Catholic moral tradition does urge us to treat each and every living member of the human species, including the early embryo, as a human person with fundamental rights, the first of which is the right to life. But even the less exalted claims made by these past advisory panels – "profound respect" and "serious moral consideration" – say a good deal about the ways the human embryo should not be treated. "Respect" is due to individuals who have inherent worth, who must be seen as ends in themselves and not merely as means. This should mean, at the very least, inviolability from direct lethal attack in the pursuit of benefits for others. (You may value the family pet, for example, but you respect your child, so you know which of the two must never be sacrificed for a dangerous nontherapeutic experiment.)

Tragically, some advisory panels that found the embryo worthy of "respect" then proceeded to set this finding aside when they made their policy recommendations. The NIH Human Embryo Research Panel, for example, favored a view that the embryo chiefly has "symbolic" value as a kind of harbinger of later human life – or has no inherent value at all, but can be assigned a status based on how beneficial it may be to destroy the embryo for research. In light of the fact that the Panel approved a wide array of lethal experiments on human embryos -- including some which required specially creating embryos solely to destroy them – even some panelists publicly observed that the Panel had come to use the word "respect" merely as a "slogan" with no moral force. 17

Five years later, NBAC tried to give more definition to what "respect" for the embryo might mean in the research context:

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.18

While this standard does not fully respect the embryo as a person with inviolable rights, it does create a presumption against research that requires killing the embryo: Such research was to be a last resort, pursued only after it is found that research benefits cannot be pursued in any other way. However, the Commission then evaded the implications of this standard, by ignoring the emerging evidence about the promise of adult stem cells and other alternatives. To be sure, the Commission did concede that its factual claim on this point would have to be reevaluated as scientific knowledge advanced.

As the National Institutes of Health acknowledged in 2001, the burden of proof needed to justify human embryo research by NBAC's ethical standard has never been met. The NIH's review of stem cell research concluded that any therapies based on embryonic stem cells were "hypothetical and highly experimental," and that it could not be determined at that time whether these cells would have any advantages over the less morally problematic alternatives.19

Since that time, in fact, scientific and practical barriers to the medical use of embryonic stem cells have loomed larger, while non-embryonic stem cells have moved quickly into promising clinical trials for a wide array of conditions. Yet many researchers have responded by simply abandoning NBAC's approach of treating embryo research as a last resort. Instead, their claim is that research using both embryonic and non-embryonic stem cells should be fully funded now, to determine which source is best for various functions.

This approach simply reduces "respect" for the embryo to nothing at all. For that is the approach one would take if there were no moral problem whatever -- if the only factor determining our research priorities were relative efficiency at achieving certain goals. "Respect" must mean, at a minimum, that we are willing to give up some ease and efficiency in order to obey important moral norms instead of transgressing them.

Interestingly, the principle of respect for human life at the embryonic stage has fared better in the more representative branches of government, among policymakers who lack graduate degrees in ethics but have a keener sense of public moral sentiment. The NIH panel's recommendations were partly rejected by President Clinton (who refused to fund experiments requiring the creation of embryos for research purposes), then completely rejected by Congress, which banned funding of any harmful experiments on preimplantation human embryos. In effect, Congress decided to treat the embryo as a human subject, to be protected from research risks as fully as the unborn child in the womb has been since 1975. Congress's provision has been reenacted every year since 1996 through annual appropriations bills, with an amendment since 1998 to ensure that embryos produced by cloning are protected.20

Some states have gone further, prohibiting harmful experiments on human embryos outright regardless of the source of funding.21 In one state, Louisiana, the embryo produced by IVF is protected as a juridical person – a standard that not only forbids harmful research, but also limits clinics' ability to perform any intervention unless it is designed to serve the embryo's opportunity for survival and live birth. The most recent state law on embryo research generally, enacted in South Dakota in 2002, also prohibits stem cell research using stem cells that one knows were obtained by destroying human embryos. In our view, laws like those in Louisiana and South Dakota are the best current examples of how respect for the life of the human embryo should influence public policy on embryo research.

Is a policy of funding embryonic stem cell research consistent with the principle of respect for embryonic human life? When the NIH proposed such funding during the Clinton administration in 1999, it was argued that researchers would not be causing any net loss of life because the "spare" embryos from fertility clinics "would have been discarded anyway" – the policy would influence only how the embryo dies rather than whether it dies.22 One is tempted to observe that this is true of any and all killing of mortal creatures. Such a justification could certainly have horrendous implications for lethal experimentation on terminally ill patients or death-row prisoners. In the realm of fetal research, federally funded researchers are barred by law from using the "will die soon anyway" defense to do harmful research on the unborn child intended for abortion (or the child dying outside the womb from an abortion).23 In any case, the final NIH guidelines issued in 2001 were not restricted to embryos slated for discarding – they extended to any embryo deemed "in excess of clinical need," which only means that the parents do not need that embryo to reproduce at the present time.24 Many of these embryos are kept in frozen storage and eventually transferred to a womb later (if they are not requisitioned for destructive research first). A recent study by the fertility industry concluded that fewer than 3% of the embryos now in frozen storage are available for research; the NIH guidelines would have encouraged researchers to press parents to choose this option more often.25

Still others have argued that by funding embryonic stem cell research, the government is not complicit in any destruction of embryos because the research only occurs after the embryos are destroyed. Yet Congress since 1996 has banned federal funding of any research "in which" embryos are harmed or destroyed, and it is difficult to see how embryo destruction is anything but an integral and essential first step in any embryonic stem cell research project. The Clinton administration's argument that such destruction and the use of the resulting cells were completely separate activities was criticized as hypocritical and evasive even by supporters of federal funding.26 Offering funds for research projects that rely on the destruction of embryos encourages such destruction to be done.

The policy articulated by President Bush on August 9, 2001 is a more subtle and complex matter. The President's stated goal was to promote the possible benefits of embryonic stem cell research without encouraging future destruction of human embryos. Therefore, he said, federal funds would only support research using cell lines already created by destroying embryos in the past.

The limited number of cell lines that the Bush Administration approved for federally funded research is meant to be adequate only for basic research, designed to determine the most promising avenues for further exploration. Some researchers have complained that the currently eligible cell lines are of insufficient volume for treatments (on the assumption that treatments will ever emerge), have inadequate genetic diversity to treat most of the patients who may want cell implants, and might be inappropriate for human transplantation because they are grown in cultures of mouse feeder cells.27 It is important to recognize, however, that ultimately these researchers will want to develop thousands of cell lines with different genetic profiles -- or develop human cloning, to create and destroy embryos that are a genetic "match" to each individual patient.

Recently a campaign was launched to reverse the current policy and authorize funding for research on new embryonic stem cell lines, cultured without the use of mouse feeder cells. Proponents have said that this expansion is necessary to take advantage of new advances in the use of embryonic stem cells. On closer examination, however, it turns out that the only advances cited are simply advances in growing the stem cells without mouse feeder cells.28 No breakthroughs have occurred to indicate that embryonic stem cells are ready or almost ready for clinical use. Use of new cell lines from frozen embryos has not been shown to be necessary for current basic research, and would still be completely inadequate for any large-scale clinical research – suggesting that the proposed policy expansion is itself a transitional step toward mass-producing embryos (by cloning or other means) solely for harmful experimentation.29 Oddly, the new cells proposed as a medium for growing embryonic stem cells are human bone marrow cells, which have themselves shown great clinical promise in both animal and human trials. Thus when the new mixture of adult and embryonic cells is transplanted into a patient, any clinical benefits may well arise from the adult cells -- but would be attributed by embryo researchers to the embryonic stem cells, and used to argue in favor of funding even more embryo destruction. This campaign illustrates that to some proponents, preferentially advancing research that relies on the destruction of embryonic human life has become virtually an end in itself.

Some view the Bush administration policy itself as a transitional policy. If new advances arise using existing embryonic stem cell lines (or from research in the private sector using new cell lines), political pressure will likely increase for expanding the policy and involving the government in active and direct support for the destruction of developing human life. If those advances do not come forward, or are rendered less relevant by more rapid advances using non-embryonic cells, interest in funding research on embryonic stem cell lines will likely fade, as occurred in the case of research using fetal tissue from abortions some years ago. In the meantime, however, the danger is that scarce research funds will have been diverted to the most morally problematic and medically oversold avenues of investigation.

In vitro fertilization itself has also come under closer scrutiny in recent years because it has produced so many "spare" embryos whose fate is now uncertain. More generally, IVF has given rise to a mentality in which human lives can be subjected to "quality control," selective discarding, intentional overproduction, and "selective reduction" (abortion) when more embryos than expected begin to develop in the womb. In addition, a growing body of evidence has begun to document an increased rate of serious birth defects among children conceived by IVF, and especially those conceived by particular IVF procedures such as intracytoplasmic sperm injection (ICSI).30 For all these reasons, efforts to promote the value of respect for human life in its earliest stages should include efforts to help move our society away from use of IVF as a reproductive procedure.

3.    The Integrity of Marriage and Family

Protecting the integrity of the relationships that make up families – particularly relationships between husband and wife, and between parents and children -- is another value implicated in modern technologies affecting the beginning of human life. These relationships are essential to our full appreciation of our own humanity.

Human rights declarations by the United Nations, besides affirming that children need "special safeguards and care, including appropriate legal protection, before as well as after birth,"31 have recognized the family as "the natural and fundamental group unit of society" which is "entitled to protection by society and the State."32 According to the U.S. Supreme Court, "the Constitution protects the sanctity of the family precisely because the institution of the family is deeply rooted in this Nation's history and tradition."33

That institution's integrity, hence its proper role in maintaining the order of society, can be eroded when relationships between husband and wife or between parent and child are blurred or redefined in some reproductive procedures. Without ignoring the needs of infertile couples, society must take care that procedures designed to help build families will not undermine the social and legal status of the family.

Of special concern are methods which introduce outside third parties into the marriage relationship for purposes of reproduction. It is now possible for a child to have as many as five parents: the "genetic" parents or sperm and egg donors, the gestational mother, and the couple that intends to raise the child. In such arrangements the child is denied his or her right to a unified family, and the moral and legal responsibilities traditionally seen as inherent in being a biological parent are diffused and rendered problematic. These practices have given rise to lawsuits in which several parents sue for custody of a child – or in which no parent is willing to claim parental responsibility. Family relationships tend to be redefined in terms of commercial contract law, risking the reduction of human beings to the status of objects. Surrogate motherhood has rightly been criticized along these lines for its tendency to exploit the biological mother as a "surrogate uterus" and to reduce the child to a commodity for sale.

A more difficult but equally important question is whether even the "simple case" of in vitro fertilization, performed using sperm and egg from husband and wife, undermines values inherent in the institutions of marriage and family. Catholic moral teaching, as well as some analyses not based on specifically religious principles, hold that it does.

In ordinary sexual procreation, a man and woman physically express their love for each other and are open to engendering a new person the two will love and care for together. This openness to new life sets the stage for parents' lifelong attitude toward their children. Their child's makeup will be a new and unpredictable combination of traits from both parents, for no one is involved in designing or forcing the production of a particular kind of child. In this way parents show respect for their children as free and equal members of the human family with their own open future -- as persons over whom we adults have stewardship, not absolute dominion.

Some reproductive technologies assist this natural process, but some ignore or violate its central features. These technologies make children result from the meeting of sperm and egg in a Petri dish, rather than from parents' union. They create opportunities for introducing third parties into the procreative act, and allow technicians to manipulate and control life at its beginning.

Human cloning is the final step down this path of depersonalized procreation. It involves no meeting of male and female at all — in fact, a child produced this way may have no "mother" or "father" in the ordinary sense, but only a template or model. Instead of openness to life, it involves domination over life — for a technician manufactures the new embryo in a laboratory, and even controls his or her genetic makeup to be identical to that of someone else. This act has the nature of a manufacturing process, suited to a commodity rather than a human being.

This is not only a Christian insight, for it is imbedded in our human nature. Says ethicist Leon Kass, now the chairman of this Council: "Human cloning would ... represent a giant step toward turning begetting into making, procreation into manufacture (literally, something "handmade") ... [W]e here would be taking a major step into making man himself simply another one of the man-made things."34

When we manufacture offspring according to preset specifications, we are violating a fundamental aspect of human procreation. We are treating our children as our "creatures." The other abuses of human cloning — the fixation on producing a child "just like me"; the willingness to subject cloned humans to high risks of death and disability; even scientists' willingness to clone embryos solely to exploit and destroy them — flow from this first fundamental error. Human cloning would create a human being who deserves to be treated as our equal, but would do so in a way that undermines or fails to appreciate this equal dignity.

Though to a lesser extent, and despite any positive motives on the part of couples who resort to it, the procedure of in vitro fertilization poses this same problem. By its nature, it fosters (at least among the scientists and technicians who actually perform it) an attitude toward children at their embryonic stage of development that invites further abuses, such as destructive experimentation and the creation of embryos for research. At the very least, then, government should not promote IVF through public funding but should discourage its use, instead promoting infertility treatments that do not pose such serious moral problems.

In 1979, when an Ethics Advisory Board reported to the Secretary of HEW on the advisability of funding in vitro fertilization projects involving humans, the Board concluded that federal support for some projects along these lines would be "acceptable from an ethical standpoint." However, the Board hastened to explain that this meant such support would be "ethically defensible but still legitimately controverted." The Board declined to make any policy recommendation on whether such support should actually be given, citing "uncertain risks" to both mother and offspring, "the dangers of abuse" such as experimental manipulation of the embryo, and the fact that the procedure is "morally objectionable to many."35 Since that time, no Administration has funded human in vitro fertilization. None should consider doing so now.

4. Conclusion: Legal and Regulatory Goals

Catholic teaching on the moral aspect of public policy calls for civil law to be brought into ever greater conformity with the moral law. It recognizes that some practices that are immoral may not be appropriate subjects for legal prohibition, or that it may not at times be possible to prohibit them without giving rise to greater harms. Our teaching insists that practices which endanger the common good, including all those which violate fundamental human rights such as the right to life, should be forbidden by law. It also recognizes that this goal at times can be achieved only by intermediate steps. Thus in our view it is never allowable to support legislation which promotes or endorses unethical practices, but one may support legislation to correct the most egregious wrongs when that is the most that can be achieved at a given time, as a step toward a legal system that is completely just.36 This teaching provides the moral context for the suggestions which follow.

Human cloning: For the reasons stated above, and those explained in our past congressional testimony and other statements on this issue,37 human cloning for any purpose should be banned at the state and federal level. S. 245, a well-crafted federal ban with bipartisan support, has been endorsed by the President, overwhelmingly approved by the House of Representatives, and endorsed by 29 co-sponsors in the Senate. Its passage is long overdue.

Human embryo research: Laws against destructive human embryo research, like South Dakota's 2002 law, should be considered and enacted in other states. Consideration should be given to a federal law against creating human embryos for research purposes in general, a legislative goal now enjoying very broad support in Europe. However, such a law may not be effective unless it is combined with legal restraints on the overproduction of embryos for reproduction (see "Regulating IVF" below), since otherwise it may be virtually impossible to prevent fertility clinics from overproducing "spare" embryos precisely in order to have embryos available for research.

Patenting human beings: Despite a longstanding administrative policy at the U.S. Patent and Trademark Office that human organisms at any stage are not fit subjects for patenting, it was recently discovered that at least one patent has been granted on a cloning procedure that seems to allow patenting of the human embryos produced by this procedure. It would be difficult to imagine a more egregious way of reducing fellow human beings to an object in which others can claim a proprietary interest. The cause of human dignity will be well served by a federal law forbidding the patenting of all human beings, including human embryos.

Federal funding of embryo research: The annual appropriations rider forbidding federal funding of harmful experiments on human embryos should be maintained. The standard of this provision should be permanently incorporated into federal regulations and/or statutes on research involving human subjects.

Federal funding of embryonic stem cell research: Contrary to the Clinton administration's legal opinion on this matter, we hold that the current appropriations rider (against funding research in which human embryos are destroyed) should be interpreted to forbid research on cells and tissues obtained by deliberately destroying human embryos. We would strongly oppose efforts to expand current policy to allow the government to fund research on cells recently obtained by destroying human embryos. If the purpose of the Administration policy was to give embryonic stem cell researchers an opportunity to show that their approach would soon provide distinctive and clinically important breakthroughs, that goal is being met, and no such breakthroughs have emerged. To use the absence of medical progress from this source as a basis for insisting on more expansive steps down the same path is irrational. Continued diversion of scarce federal research funds toward embryonic stem cell research, when the disease conditions for which it was hailed as a treatment – diabetes, Parkinson's disease, sickle cell anemia, immune deficiency, spinal cord injury, etc. – are being more rapidly and safely addressed by other means, now threatens to slow medical progress.

Federal funding of in vitro fertilization: The EAB's reasons for not recommending federal funding of IVF in 1979 remain valid and are better documented than ever. The federal government should not begin funding IVF, even on the grounds that this may allow an opportunity to regulate the IVF industry to prevent more egregious abuses. It is precisely the insistence by some that the government must fund this practice in order to regulate it that has produced an impasse regarding regulation of IVF for 25 years. In our view, it is the inherent nature of IVF that has led to these many abuses. In our society, a decision to provide federal funding is inevitably taken as a declaration that a given practice is ethically acceptable and should be promoted as a public benefit. The opposite is the case with regard to IVF.

Regulating IVF: Public policy on IVF should help move our society away from this practice and toward responses to infertility that do not pose its many risks and moral problems. The strongest reason for legislating in this area is the protection of developing human life. Louisiana's law recognizing the laboratory-produced embryo as a person, for example, discourages harmful experimentation, overproduction of embryos, routine embryo freezing, and other abuses; some European countries have enacted laws with similar goals. Yet the only current federal law in this country regulating IVF, a voluntary registry documenting "success" rates,38 has many deficiencies. It rates "success" in terms of the percentage of ovarian stimulation procedures that end in live birth, rather than the percentage of embryos produced who survive to live birth – a standard that may actually encourage irresponsible use of fertility drugs and the transfer of multiple embryos to the womb at one time. Nor does it address the issue of whether less invasive or problematic fertility procedures have been fully considered before IVF is recommended, or the issue of the effects of superovulatory drugs on women's future health. The Food and Drug Administration also claims a role in regulating potentially unsafe fertility procedures; presumably including the new evidence on the increased rate of birth defects from ICSI and other IVF procedures. In FDA's current mandate to assess the safety and effectiveness of drugs and devices, however, it is not clear that "safety" must include the safety of the human embryo – a practice that produces no health problems in liveborn children because these problems are resolved by destroying the affected human at the embryonic or fetal stage is not "safe." Our Conference is concerned about the relative absence of legal protection for mothers and offspring who may be harmed by the fertility industry, and will be interested to see this Council's recommendations on this problem.

Conclusion

I want to end on a positive note. The Church's negative moral assessment of harmful human embryo research is not a negative assessment of medical research or advances in better understanding the genetic roots of disease. The opposite is the case. One of the wonders of modern science is its creative diversity, its constant ability to find different paths to the same positive goal. It is our hope that by rejecting research avenues that rely on the destruction of developing human life, our society will be able to devote itself all the more enthusiastically to ethically responsible medical research and the dissemination of its benefits to all human beings, especially the poorest and most vulnerable.

We hope that those who disagree with us on these moral issues will nonetheless rejoice with us that research avenues posing no moral problem are rapidly advancing to treat previously incurable diseases, offering us opportunities to work together on forms of medical progress that all can support and that all patients can benefit from with a clear conscience. We see in this area of policy no conflict between ethics and medical progress. Medical research can and should always be guided by fundamental ethical norms to benefit all members of the human family.


See the Appendix: Modern Embryology and the "Pre-Embryo".


Footnotes

1. Claude Bernard, An Introduction to the Study of Experimental Medicine (1865), quoted in Stephen Post, Inquiries in Bioethics (Georgetown University Press 1993), p. 145.

2. See "The Nuremberg Code (1947)" (www.cirp.org/library/ethics/nuremberg/). The Code acknowledges one possible exception to this last norm, which if taken absolutely would itself be problematic: "those experiments where the experimental physicians also serve as subjects." Researchers have a moral responsibility to take due care of their own lives as well.

3.World Medical Association, "Declaration of Helsinki" (www.wma.net/e/policy/17-c_e.html).

4. World Medical Association, "Declaration of Geneva," reprinted in Reiser, Dyck and Curran (eds.), Ethics in Medicine (The MIT Press 1977), p. 37. In the Declaration's 1994 revision, this phrase was amended to "human life from its beginning" (www.wma.net/e/policy/17-a_e.html).

5. Ronald Green, in Transcript of the NIH Human Embryo Research Panel (National Institutes of Health: Rockville, MD 1994), Monday, April 11, 1994, p. 92.

6. Joseph Fletcher, Situation Ethics: The New Morality (Philadelphia: Westminster Press 1966), pp. 120-21.

7. "The Church has a great esteem for scientific and technological research, since it 'is a significant expression of man's dominion over creation' (Catechism of the Catholic Church, n. 2293) and a service to truth, goodness and beauty." Pope John Paul II, Address to the Jubilee of Scientists (May 25, 2000), para. 4.

8. See Pope John Paul II, Encyclical letter Veritatis Splendor (The Splendor of Truth) (1993), paras. 52, 67.

9. R. Green, "Toward a Copernican Revolution in Our Thinking about Life's Beginning and Life's End," 66 Soundings (1983), pp. 152-73, cited in National Institutes of Health (NIH), Report of the Human Embryo Research Panel (September 1994), p.49 n. 13.

10. See Americans to Ban Cloning, "State Bills on Human Cloning," March 26, 2003,www.cloninginformation.org/info/ABC-State-Laws.htm.

11. Eva Mozes-Kor, quoted in A. Caplan (ed.), When Medicine Went Mad (1992), p. 7.

12. "Report of the Ethics Advisory Board," 44 Federal Register 35033-58 (June 18, 1979) at 35056.

13. NIH, Report, note 9 supra, p. 2.

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

15. National Academy of Sciences (NAS), Scientific and Medical Aspects of Human Reproductive Cloning (National Academy Press 2002), p. E-5.

16. Transcript, note 5 supra, February 3, 1994, pp. 97-8 (remarks by chairman Steven Muller). 17. Transcript, note 5 supra, April 11, 1994, p. 40 (remarks by Dr. Bernard Lo).

18. NBAC, note 14 supra, p. 53.

19. NIH, Stem Cells: Scientific Progress and Future Research Directions (Dept. of Health and Human Services, June 2001), p. 17; also see p. 63 (any possible advantages of embryonic cells remain to be determined), p. 102 (not known whether these cells are better suited for gene therapy).

20. The current version of this provision is Sec. 510 of the Consolidated Appropriations Resolution of 2003, Pub. L. 108-7.

21. See USCCB Secretariat for Pro-Life Activities, "Current State Laws Against Human Embryo Research," www.usccb.org/prolife/issues/bioethic/states701.htm. Also see id., "Current State Laws on Human Cloning," www.usccb.org/prolife/issues/bioethic/statelaw.htm.

22. See NBAC, note 14 supra, p. 53.

23. See 42 USC §289g.

24. "National Institutes of Health Guidelines for Research Using Human Pluripotent Stem Cells," 65 Federal Register 51976-81 (August 25, 2000) at 51980.

25. D. Hoffman et al., "Cryopreserved embryos in the United States and their availability for research," in 79 Fertility and Sterility (May 2003), pp. 1063-9.

26. Says ethicist Glenn McGee, who supports embryo research: "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 on the part of the NIH. 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." Quoted in J. Spanogle, "Transforming Life," The Baylor Line (Winter 2000), p. 30.

27. Editorial, "Downside of the Stem Cell Policy," in The New York Times, August 31, 2001, p. A18.

28. R. Weiss, "Stem Cell Strides Test Bush Policy," in The Washington Post, April 22, 2003, p. A1.

29. By recent estimates, if all the human embryos in frozen storage up to the present time that are designated for research use were destroyed solely to obtain stem cells (deemed a "highly unlikely" scenario), this might produce a total of 275 cell lines. See Hoffman et al., note 25 supra, p. 1068. Clearly frustrated by most fertility patients' reluctance to donate their embryonic offspring for destructive research, the New York Times has proposed that these couples should be "pressed" to determine the fate of their frozen embryos "after a reasonable period." Editorial, "400,000 Embryos and Counting," in The New York Times, May 15, 2003, p. A34. A more recent opinion piece in the Times cites two prominent researchers in support of the claim that merely determining the "best options for research" will require "perhaps 1,000" stem cell lines - about four times as many as those which could be obtained by destroying every available human embryo placed in frozen storage up to the present day nationwide. S. Hall, "Bush's Political Science," in The New York Times, June 12, 2003, p. A33.

30. See, for example: B. Strönberg et al., "Neurological sequelae in children born after in-vitro fertilization: a population-based study," in 359 The Lancet (2002), pp. 461-5; M. Hansen et al., "The risk of major birth defects after intracytoplasmic sperm injection and in vitro fertilization," in 346 The New England Journal of Medicine (2002), pp. 725-30; E. Maher et al., "Beckwith-Wiedemann syndrome and assisted reproduction technology (ART)," in 40 Journal of Medical Genetics (2003), pp. 62-4.

31. Declaration of the Rights of the Child (1959), Preamble.

32. Universal Declaration of Human Rights (1948), Article 16.

33. Moore v. City of East Cleveland, 431 U.S. 494, 503 (1977) (plurality).

34. L. Kass, "The Wisdom of Repugnance," in The New Republic, June 2, 1997, p. 23.

35. See "Report of the Ethics Advisory Board," note 12 supra, 35056-8.

36. "Though it is true that sometimes it is lawful to tolerate a lesser moral evil in order to avoid a greater evil or in order to promote a greater good, it is never lawful even for the gravest reasons to do evil that good may come of it (cf. Rom. 3:8)." Pope John Paul II, note 8 supra, para. 90, quoting Pope Paul VI. On the issue of "imperfect" or incremental legislation, also see Pope John Paul II, Encyclical letter Evangelium Vitae (The Gospel of Life) (1995), para. 73.

37. See www.usccb.org/prolife/issues/bioethic/cloning/index.shtml.

38. See 42 USC §§236a-1 to 236a-7. 



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