Subject: Embryo Research and Related Issues

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

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

Another important excerpt:

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

For myself, I found the following from his monograph of great significance:

"... 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."

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