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Reproduction and Responsibility:

The Regulation of New Biotechnologies


 

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



Personal Statements

The preceding ten chapters constitute the official body of this report; it stands as the work of the entire Council. In the interest of contributing further to public discussion of these issues, and of enabling Members of the Council to speak in their own voice on one or another aspect of this report, we offer in this Appendix personal statements from those Members (and groups of Members) who have elected to submit them:

Statement of Rebecca S. Dresser, J.D., M.S.; Mary Ann Glendon, J.D., M.Comp.L.; Charles Krauthammer, M.D.; and James Q. Wilson, Ph.D.    

Statement of Rebecca S. Dresser, J.D., M.S.    

Statement of Daniel W. Foster, M.D.; Michael S. Gazzaniga, Ph.D.; Janet D. Rowley, M.D.; Michael J. Sandel, D.Phil.; and James Q. Wilson, Ph.D.    

Statement of Francis Fukuyama, Ph.D. and James Q. Wilson, Ph.D.    

Statement of Michael S. Gazzaniga, Ph.D.    

Statement of Robert P. George, J.D., D.Phil; Mary Ann Glendon, J.D., M.Comp.L.; Alfonso Gómez-Lobo, Dr. phil.; William B. Hurlbut, M.D.; and Gilbert C. Meilaender, Ph.D.    

Statement of Robert P. George, J.D., D.Phil and Alfonso Gómez-Lobo, Dr. phil.    

Statement of Leon R. Kass, M.D., Ph.D.    

Statement of Paul McHugh, M.D.    

Statement of Janet D. Rowley, M.D. 

   

Personal Statement of Professor Dresser, Professor Glendon, Dr. Krauthammer, and Professor Wilson

This document represents a singular achievement. To achieve unanimity on any issue in bioethics is difficult enough. To achieve it on an issue as contentious as the treatment of a human embryo is more difficult still. Yet, this Council has found unanimous consensus on the recommendations in this report. Even more remarkable is that this unanimity has been achieved on a Council of such extraordinary philosophical and ideological diversity.

Regardless of our different positions on the moral status of the embryo and on the autonomy that ought to be granted to science, it turns out that we can agree on certain fundamental human goods that are at stake and that deserve not just moral but legal protection. As a result, we are in a position to recommend to Congress, which represents a similar diversity of philosophical and ideological inclinations, a concrete roadmap on how to proceed.

These recommendations establish basic guidelines—"fences"—defining activities that lie outside the bounds of decency, while at the same time providing the converse service of defining the boundaries within which we continue to contend and disagree.

We are proud to associate ourselves with this document.

Rebecca S. Dresser
Mary Ann Glendon
Charles Krauthammer
James Q. Wilson


Personal Statement of Professor Dresser

Reproduction and Responsibilitymakes several major contributions. First, it is a detailed and comprehensive account of existing policy and professional standards relevant to assisted reproductive technologies (ARTs). Second, it highlights significant gaps in the current oversight system. 

One such gap concerns safety. The federal regulatory system fails to ensure that newly developed ART interventions receive the same level of scientific and medical review as do other novel interventions with potential human applications. As a result, novel ART interventions may be attempted in human subjects without sufficient preclinical data showing that the approach is safe enough to try in humans. Such interventions may also enter the medical arena without the rigorous evidence of safety and efficacy normally required before drugs and other products are approved for clinical use.

Protection of human subjects can also be inadequate. Infertility specialists developing new approaches are not always affiliated with an academic or other medical center mandating institutional review board evaluation prior to human applications. Thus, there is no assurance that prospective parents will be informed of a technique’s unproven status, its risks, and the alternative measures that might be available to them. Another problem is that federal agencies lack policies explicitly addressing situations in which investigational modifications affecting embryos could have health consequences to a later-born child. The children whose health could be affected by ART innovations, as well as the parents of such children, should benefit from the same regulatory protections governing human research and introduction of new medical interventions as do other human beings.

More extensive oversight by the Food and Drug Administration would be one way to address these regulatory gaps. Yet as Reproduction and Responsibility observes, more assessment and analysis are needed to determine which specific regulatory actions would be most effective and least burdensome. At the same time, this report supplies a solid foundation for moving forward with oversight to protect people affected by ART in the research and clinical settings.

Reproduction and Responsibilitymakes a third contribution in offering additional guidance for federal oversight. One activity the report discusses is stem cell and other research that requires the destruction of human embryos. I agree with my colleagues Daniel Foster, Michael Gazzaniga, Janet Rowley, Michael Sandel, and James Wilson that certain legislative recommendations in this report could be helpful in advancing the current national debates over cloning and human embryonic stem cell research. The longstanding congressional restrictions on federal funding for embryo research and similar longstanding disputes over the ethics of creating embryos for research suggest that meaningful policy changes will require those with diverse views to cooperate and to seek common ground. The report’s recommendations emerged from this sort of process.

Members of this Council know all too well the impediments to achieving consensus among individuals with very different positions on the moral status of early human life. Barriers to consensus also exist when group members disagree on the moral and social value of technologies that enable more people to have biologically related children, expand opportunities to test embryos and fetuses for genetic traits, and offer researchers new avenues for studying preimplantation embryos. Reproduction and Responsibility represents a deliberative success, for it includes a collection of recommendations endorsed by people with extremely diverse values and beliefs about these matters. Thus, its greatest contribution may be to demonstrate that mutual respect, accommodation, and compromise on embryo research and acceptable ART practices are possible in this pluralistic and polarized country of ours.

Rebecca S. Dresser


Personal Statement of Dr. Foster, Dr. Gazzaniga, Dr. Rowley, Professor Sandel, and Professor Wilson

We endorse the legislative recommendations contained in this report, on the following grounds: First, the limitations these regulations impose on the treatment of embryos in assisted reproduction and research give proper expression to the moral significance of human embryos. Although we do not regard embryos as the moral equivalent of fully developed human beings, we believe that they are more than mere things, and should not be used wantonly or treated with moral indifference. The proposed regulations offer a way to prevent such wanton or casual treatment, and so accord human embryos the respect they are due.

Our second reason for supporting these regulations is that they point to a possible solution to the vexed issues of cloning and stem cell research that could overcome the current impasse in the U.S. Senate. Despite widespread opposition to reproductive cloning, the Senate has been unable to ban it because of disagreement about cloning for biomedical research. The obvious solution is to detach the two questions, but until now, it has proven difficult to do so. One way of banning reproductive cloning alone would be simply to prohibit the transfer of a cloned embryo into a woman’s uterus, as Britain has done. Some object, however, that such a law would effectively make it a crime not to destroy a cloned embryo.

The formulation proposed in this report offers a way of banning reproductive cloning that avoids that difficulty.  It proposes that Congress “prohibit attempts to conceive a child by any means other than the union of egg and sperm.” We believe that this language provides a way for Congress to ban reproductive cloning while agreeing to disagree on the question of cloning for biomedical research; such a solution would prevent attempts to created cloned children while allowing debate to continue about cloning for stem cell research and regenerative medicine.

The proposed regulations, taken together, also point toward a possible compromise on federal funding of stem cell research. Some object to embryonic stem cell research on the grounds that embryos are persons and therefore inviolable. But others object on different grounds. They worry that, in the absence of clear limits, embryo research could lead down a slippery slope of exploitation and abuse: if today we derive stem cells from blastocysts, tomorrow some might seek to transfer embryos into a women’s uterus, or even a pig’s uterus, to grow organs for transplant, creating the nightmare prospect of embryo farms, fetuses exploited for spare parts, and the commercialization of human life.

One great merit of the regulations contained in this report is that, if implemented, they would address the slippery slope argument against embryonic stem cell research by assuring that such research is done responsibly, within carefully prescribed limits. No embryos used for research could be used or preserved beyond a 10-14 day limit, or transferred into a woman’s uterus or an animal’s body to grow organs for harvest; nor could embryos be bought and sold. Regulations such as these will not fully satisfy the objections of those who oppose stem cell research on the grounds that blastocysts are morally equivalent to babies. But by assuring that stem cell research is conducted within carefully prescribed limits, these regulations effectively address the concern that stem cell research today will lead us down a path to exploitation and abuse tomorrow. The proposed regulations could, therefore, point the way toward a compromise on federal funding along the lines that Senator Bill Frist proposed in July 2001:

After grappling with the issue scientifically, ethically and morally, I conclude that both embryonic and adult stem cell research should be federally funded within a carefully regulated, fully transparent framework. This framework must ensure the highest level of respect for the moral significance of the human embryo.  Because of the unique interaction between this potentially powerful new research and the moral considerations of life, we must ensure a strong, comprehensive, publicly accountable oversight structure that is responsible on an ongoing basis to moral, ethical and scientific considerations.

Senator Frist proposed a number of regulations, similar in spirit to the ones proposed in this report, that would permit federal funding of embryonic stem cell research, at least on cell lines derived from blastocysts from in vitro fertilization (IVF) clinics that would otherwise be discarded. Although we would not restrict stem cell research to blastocysts left over from IVF clinics, we realize that this remains a controversial question. The compromise toward which the regulations in this report point might leave aside the question of funding for stem cell research on cloned embryos, and move forward on areas of potential agreement.

Recent scientific developments illustrate the need to adjust federal funding policy along the lines Senator Frist proposed in 2001. Only 17 cell lines are currently on the NIH Registry and available for federally funded research, and many of those are subject to stringent licensing requirements. In March, Harvard biologist Douglas Melton announced the creation of 17 new embryonic stem cell lines that he is making available free of charge to scientists for noncommercial research purposes. The Harvard stem cell lines meet all the criteria proposed by Senator Frist: They were derived, using private funds, from blastocysts left over from IVF clinics that would otherwise be discarded, with the consent of the donors. And yet, under current federal policy, research on these cell lines is ineligible for federal funding. The reason: Unlike the 17 stem cell lines currently available for federal funding, the new Harvard cell lines were derived after 9:00 P.M. on August 9, 2001, the deadline announced by President Bush in his address to the nation on stem cell research.

Whatever one’s view of the moral status of the embryo, it is difficult to understand the moral distinction between research on stem cell lines created before 9:00 P.M. on August 9, 2001, and research on stem cell lines created since. We endorse the regulations proposed in this report in the hopes that these regulations can point the way to a national compromise on cloning and stem cell research that will enable this country to promote the promise of stem cell research while upholding the highest ethical standards.

Daniel W. Foster
Michael S. Gazzaniga
Janet D. Rowley
Michael J. Sandel
James Q. Wilson

Personal Statement of Professor Fukuyama and Professor Wilson

We believe that the Reproduction and Responsibility report is a very important document that articulates a broad moral consensus over the limits that our society should place on new reproductive procedures now made possible by technology. The proposed legislation, if passed, would ban certain clearly unacceptable techniques (including reproductive cloning) while at the same time neither prohibiting nor condoning research cloning or other forms of embryo research. As such, it shows a way to get past the current deadlock that leaves the United States as one of the few developed countries without guidelines on these issues.

Appropriate as these guidelines are, we believe that they represent only a first step toward a more complete regulatory approach needed to deal with new technological possibilities. Today we can foresee possibilities like reproductive cloning or human-animal hybrids that should be banned. But technology will move quickly and in the future pose ethical challenges, as well as scientific and medical opportunities, that we cannot today imagine. It will be difficult and inappropriate for Congress to intervene seriatim as these developments occur. What is called for instead is a modernization of our existing regulatory structure to allow it to respond with flexibility in such cases, taking account not simply of the safety and efficacy of new procedures but of ethical concerns that would be widely shared in our society.

Our hope is that the current report will represent not the final word on the subject of legislative limits but the beginning of a broader discussion of regulatory oversight of new reproductive technologies. As a general rule, we do not welcome government intrusion into scientific inquiry and into the reproductive choices made by parents. But regulation frequently facilitates scientific advance and individual choice by reassuring the public that it is being done responsibly. That is the light in which the current report should be seen, as well as hoped-for future efforts to update and modernize our regulatory system.

Francis Fukuyama
James Q. Wilson

Personal Statement of Dr. Gazzaniga

This is a complex report. The explicit objective of this report is to propose some sort of regulatory mechanism that monitors the possible uses and misuses of a variety of existing artificial reproductive techniques. The policy recommendations made at the end of the report are presented in that context. At the same time the importance of this report is the implicit implications of those recommendations. While unstated, the implication is to ban reproductive cloning, but is silent on biomedical cloning. It is hoped that this will allow stem cell research to go forward in some way that is advancing this biomedical pursuit and public good. I accept the foregoing rationale for concurring with this report as articulated by Foster, Rowley, Sandel, Wilson and myself, but I do so reluctantly. I much prefer a more broad and bold explicit statement.

What overhangs this discussion is the question of the moral status of the embryo. In what follows, I present my thoughts on that issues as concurrently published in a letter to Science. In the meantime I feel obliged to stake out a far more assertive position.  The current compromise does not capture the goods that can be achieved by allowing biomedical cloning to go forward with the full support of the federal government for not only research on spare IVF embryos, but also biomedical cloning that allows somatic cell nuclear transfer procedures. The report does not make explicit that federal funding for research should go on for all of these endeavors. 

The reason the explicit aspects of this report are now proposed is because federal funding has been withheld from embryo research of any kind in the past. It is now clear proper epidemiological studies would be good not only for ART but also for a wide variety of other current medical practices. By not explicitly allowing federal funding for biomedical cloning as well as new stem cell lines we are painting ourselves into yet another corner down the road.

I firmly believe that the problems underlying all of these social and medical dilemmas derive from a profound misunderstanding of what an embryo is and is not. If greater understanding could be brought to that issue, we all could move forward in a reasoned and rational way. The following forthcoming letter to Science (“Human Being Redux,” April 16, 2004) was prompted by the recent advances in biomedical cloning in Korea and addresses this issue:

Here we go again. It was two years ago that as one of the member’s of the President’s Council on Bioethics, I among others outlined a logic for letting biomedical cloning go forward. No one is for reproductive cloning—or cloning for baby making as it is sometimes called. But cloning for biomedical research, a process that only involves cells in a Petri dish and might well relieve untold human suffering is another matter.

Now, two years later, the good scientists of South Korea have made a major advance in biomedical cloning. They have shown the world that careful and caring biomedical cloning, cloning that allows for the production of stem cells, which might lead to breathtaking remedies for horrible diseases, is possible. Two years ago the reason many people were against letting the American biomedical community into this intellectual and scientific hunt was that by allowing biomedical cloning, the human race would lose its dignity. Tell me, does any reader feel diminished in the past few days? Do the one million Americans who suffer from Parkinson’s disease, whose human dignity has been brutally robbed from them, feel an even greater affront? 

How did we get into this mess, the position that the greatest biomedical discovery machine in the history of the world, the American basic science enterprise, is sitting on the sidelines? It is in part due to religious zealotry and in part due to superficial reasoning by well meaning people. At the center of the discussion is the belief on the part of some that a blastocyst, the entity in the Petri dish, is morally equivalent to a living post-natal human being. For those who simply assert that equivalence, no matter what the scientific data might be, there is nothing more to be said. But for those who think the equivalence is due to ‘scientific fact’ there is hope they may come to a deeper understanding of the nature of the problem.

Many people recognize that the human embryo, the entity that is created by the union of an egg and sperm, carries all the genetic information of a member of the human species. Thus, they call the embryo a human being. Of course, to develop into a human being, the embryo has to become implanted into the uterus of a woman and be allowed to develop. This potential to become a human being is what sticks in the minds of the supporters of the moral equivalence argument and this is why manipulations of embryos for anything but normal reproduction is not acceptable to them.

Looking at a minuscule ball of cells in a Petri dish, so small that it could rest on the head of a pin finds one hard pressed to think of it as a human being. After all, it has no brain or capacity to think and feel. The ball of cells has the potential if it was to be implanted into a woman but so do the egg and sperm ‘set’ before they meet. Why don’t we revere those entities? Well, it is argued, because they don’t have the full compliment of genetic material that could make up a human being. Those that see a bright line here, the line between an entity with the combined genetic material versus the uncombined entities, are forgetting the central discoveries of neuroscience and developmental psychology.

Merely possessing the genetic material for a future human being does not make a human being. The developing embryo that becomes a fetus that becomes a baby is the product of a dynamic interaction with its in vivo environment, its post-natal experiences, and a host of other factors. A pure genetic description of the human species does not describe a human being. A human being represents a whole other level of organization as distinct from a simple embryo as an embryo is distinct from an egg and sperm. It is the dynamics between genes and environment that make a human being. Indeed, most of us are willing to grant this special status to a developing entity way before it actually exists, but surely not before the entity even has a brain.

The South Korean scientists seem to understand these distinctions. They are not in the baby making business and want no part of it. They have constructed a great fence around developing embryos through a cloning process unfolding in a Petri dish. Their embryos are allowed to develop for only a few days whereupon the all-important stem cells are harvested for possible therapeutic use and at the exact same time the rest of the cell mass dies. There is no slippery slope here, there is no beginning of the much-feared world of cloned humans and the like. The Koreans have found a way to let biomedical cloning go forward with all of its spectacular promise for restoring human dignity to the seriously diseased and infirmed patients of the world while at the same time not in any way creating a social atmosphere to use such advances for baby making. What could be better?

America can solve its dilemma quickly and easily. Congress could vote to outlaw reproductive cloning. At the same time, they could allow biomedical cloning to go forward. The definitional problem of what it means to be a human being is becoming clearer and the much feared slippery slope argument has been put to rest. Biomedical cloning, Si, reproductive cloning, No!

Michael S. Gazzaniga

Personal Statement of Professor George, Professor Glendon, Dr. Gómez-Lobo, Dr. Hurlbut, and Professor Meilaender

With the release of this report, the President’s Council on Bioethics has continued and advanced the development of its position on difficult and controverted questions that arise at the beginning of human life. We append these comments in order to offer a brief analysis of what the Council has said and to place what it says here into the context of its earlier work. In particular, we think it important to highlight a few recommendations for interim legislation offered by the Council at the very end of the report. It is essential to see what the Council has said and equally essential to note where it has been silent.

Among the Council’s recommendations is the following: Congress should “prohibit attempts to conceive a child by any means other than the union of egg and sperm.” Were such legislation enacted, it would be unlawful to attempt to produce a child through cloning. Readers should note with care the definition given in a footnote of the act prohibited here. It is “the creation ex vivo of any such human embryo with the intent to transfer it to a woman's body to initiate a pregnancy.” Two important implications follow:

(a) One might, of course, produce a human embryo by somatic cell nuclear transplantation or some other cloning technique with no intent whatsoever to transfer it to a uterus (no doubt in order to conduct research on such an embryo, what the Council has elsewhere called “cloning-for-biomedical-research” and for which some use the incorrect language of “therapeutic cloning”). About this possibility the Council is entirely silent. It does not recommend or endorse such action. Nor does it take a position about whether it should be legally permitted or forbidden. In the absence of any new recommendation, readers may therefore rightly conclude that the Council’s earlier majority recommendation (in its report, Human Cloning and Human Dignity) that a four-year moratorium on all cloning-for-biomedical-research should be instituted continues to be the Council’s position.

(b) Because the prohibited act would be the “creation ex vivo” of a human embryo by any means other than the union of egg and sperm “with the intent to transfer it to a woman’s body to initiate a pregnancy,” the Council's recommended legislation would never require the destruction of any embryo. The prohibited act is not—it is crucial to note—implantation in a woman’s uterus of embryos, but, rather, creation of such embryos with the intent to implant. Implantation, apart from creation with the intent to transfer, is not in any way prohibited. Hence, this actually provides additional clarity to the Council's recommendations in Human Cloning and Human Dignity.

There is one important issue on which the Council has not yet achieved sufficient agreement to offer a recommendation—and on which it, therefore, is entirely silent in the recommendations of this report. That is the issue of the use in research of human embryos at an early stage of development that have been conceived ex vivo by union of egg and sperm (i.e., embryos that are not created by SCNT or other asexual process of reproduction). The Council has been able to agree that research on human embryos should be prohibited beyond a designated stage of their development. (Some members of the Council would extend the period up to fourteen days after fertilization, but none favors permitting research on embryos that have developed beyond that point. Others would draw the line at ten days or earlier. We, and perhaps other members of the Council, have grave concerns about research that destroys human embryos at any stage of their development.) But the Council says no more than that. In particular, we should note two significant silences:

(a) The Council is entirely silent about whether research on human embryos before the 10/14 day limit should be conducted or legally permitted, and, hence, the Council has in no way endorsed such research.

(b) Because of its silence on this matter, the Council does not endorse the destruction of human embryos at any stage of their development.

Although the Council’s earlier report, Human Cloning and Human Dignity, dealt only with embryos produced by cloning, these silences cohere well with the position endorsed by the Council majority in that report and with current policy of the federal government to prohibit federal financing of any research using stem cells derived from human embryos produced after August 9, 2001 (the date of the institution of that policy). Chapter 2 of the Council's earlier report, Monitoring Stem Cell Research, has explored the moral underpinnings and legal significance of that policy, and the recommendations the Council now makes in this new report represent a further advance in drawing out some of the implications of that moral commitment.

We are, therefore, happy to join all our colleagues on the Council in endorsing the recommendations in Reproduction and Responsibility, and we are pleased that we have been able, especially in areas of great controversy, to agree on the matters we have briefly outlined above.

Robert P. George
Mary Ann Glendon
Alfonso Gómez-Lobo
William B. Hurlbut
Gilbert C. Meilaender


Personal Statement of Professor George and Dr. Gómez-Lobo

In our statement attached to the Council’s report Human Cloning and Human Dignity and in other writings, we have set forth our reasons for holding that human beings are entitled to full respect and legal protection, irrespective of age, size, location, stage of development, or condition of dependency. We reject the proposition that human beings may at certain stages of development, for example, the embryonic, fetal, and infant stages, legitimately be treated as disposable research material. So we support the ban on federal funding of experimentation and research involving the deliberate destruction of human beings in the embryonic stage, or any other, and we hope that the day will come when such experimentation and research is effectively prohibited. At the same time, we understand and fervently share the desire of those who favor embryo-destructive experimentation and research to develop cures for dreaded diseases and add to the sum of human knowledge. We believe that biomedical science should move forward aggressively by every ethically legitimate means. We do not, however, believe that deliberate embryo killing is morally defensible.

Our nation is divided on the question whether human beings in the embryonic stage deserve full respect and legal protection, and that division is reflected on our Council as it is in the Congress. However, the nation is not divided, nor is the Council or the Congress, on the question whether some limit must be placed on the destruction of nascent human life for purposes of experimentation and biomedical research. There is near unanimity in rejecting the idea of generating human embryos and gestating them for the purpose of harvesting their tissues and organs. Even those of our colleagues and fellow citizens who are prepared to countenance the destruction of human embryos in the blastocyst stage for what they regard as a greater good agree that the law should forbid damaging or deadly experimentation on embryos at later stages of development. Yet federal law currently establishes no limit. In the present report, we join in unanimously recommending that Congress establish a certain number of days beyond the first cleavage after which embryo-destructive experimentation is legally prohibited.

Our report does not designate a particular number of days, though no member of the Council has suggested that embryo-destructive research should be permitted beyond fourteen days after the first cleavage. Some would set the limit at ten days, others perhaps earlier. As noted, we ourselves are among the members of the Council who favor protecting human life from the very beginning by banning the use of living human embryos at any stage of development as disposable research material. Until this becomes politically feasible, we support efforts to accord as much protection as possible by limiting the number of days beyond which the law tolerates deliberate embryo killing.  It is important to understand that the Council’s recommendation here is not to authorize embryo-destructive research up to a certain limit. It is only to prohibit such research beyond a certain limit. Because in the absence of legislation this research remains unrestricted, a prohibition of embryo-destructive research beyond a certain limit does not amount to authorizing research up to that limit.

It is our hope that citizens who share our fundamental commitment to the principle of the full and equal dignity of every member of the human family will join us in endorsing the Council’s unanimous recommendation to Congress to establish a limit on embryo-destructive research. We pledge to join with them in working to establish yet more complete protection for human life in all stages and conditions.

Robert P. George
Alfonso Gómez-Lobo


Personal Statement of Dr. Kass

The intersection of assisted reproduction and genomic knowledge confronts us with a daunting array of new opportunities and new questions. But the question of questions in this field is this: Can human beings find a way to govern the uses of biotechnology, so as to have it serve worthy human ends without eroding human freedom and dignity? And if we can, how shall we do it? This report on the regulation of biotechnology is offered as the first step in what I hope will be a serious and vigorous national attempt to answer these questions.

The report begins that attempt by properly defining the field, and asking questions not just about one or another technique, but about the ways in which biotechnologies of reproduction touch the lives of children, women, and men. This report is not about cloning, stem cell research, or the moral status of human embryos, though it certainly bears on them. Those topics the Council addressed in previous reports. This report is about the larger whole of which those controversies are parts, and by looking at the whole the Council has managed to find common ground in particular areas where before none seemed to exist.

Although its recommendations may be helpful in making progress on some familiar and contested policy questions, the report’s major contribution is to show how a heterogeneous group of individuals, whose opinions range almost as widely as those of the American people, has agreed on the need to set limits on some uses of some biotechnologies, in order to protect common values.

Such agreement has been lacking in the past because people on very different sides of the issues have feared or opposed formal governmental oversight and regulation in this area. Some scientists and biotechnologists want no interference with scientific research and medical progress, and oppose especially those restraints that rest on moral grounds. On the other hand, some people with profound moral objections to certain types of research do not want to see governmental regulation of this field, fearing it would implicitly sanction the activity being regulated. I appreciate the reasons and principles behind these two stances. But I respectfully submit that both groups have principled reasons to seek and support public policies that defend shared values. Prudent scientists, technologists, and entrepreneurs should realize that it is in the interest of responsible science for them to join the regulatory discussion and propose some principles and boundaries that they themselves could welcome and would like to see upheld. And prudent defenders of the sanctity of human life should realize that it is a Pyrrhic victory to keep the federal government out of certain activities, if the price of such a stance means that worse practices are allowed to proceed without oversight or regulation in the private sector.

This report demonstrates that when people of such different views do pursue some common ground, practical ways forward can be found, even while serious disagreements remain. I hope that people on all sides of these issues, in the Congress and the public, will take up the challenge posed by this report, will take the first steps recommended in this report, and will take further steps along these lines as well.

Those further steps should try to expand the scope of common agreement, and also to seek more lasting ways to turn agreement into concrete policy. After all, bioethics commissions come and go. They take up important issues. They write reports. Sometimes, as in this case, the reports contain recommendations that may find a willing audience. But they have no oversight or regulatory authority. Their power consists only in their ability to persuade, and that is as it should be.

But in this rapidly developing world of biotechnology, where the human import of the changes we are undergoing is hard to discover and where social institutions lag far behind in their ability to cope with the new challenges that innovations may bring, a case can be made for the importance of trying to devise suitable regulatory institutions and activities that could help protect society’s basic values, even as we continue to treasure the benefits that biotechnology will continue to bring us. Legislation and prohibitions are suitable only for a few rare violations (such as human cloning, or euthanasia, or some of the prospects taken up in this document). Laissez-faire, while reflecting the honored American principles of freedom and choice, offers no guidance other than the market. Regulation would seem to offer a superior alternative, even if it is far from clear what form it should take or how it might be effected.

Concrete steps like those proposed in this report might begin to pave the way toward greater clarity on such questions, and they may help us to see whether or not further regulation is called for, what forms it might take, and what common goods it should seek to uphold.

The path forward is difficult, but people on all sides have something vital to defend, not only for themselves but for all of us. I would hope that people might join together, as we have tried to do here, to seek out the common ground and to try to gain greater understanding of and control over where biotechnology is taking us.

Leon R. Kass

Personal Statement of Dr. McHugh

I am pleased to endorse the legislative recommendations that have emerged from our Council’s discussions and are contained in this report. I believe the report will help move our governmental representatives toward important solutions in a most problematic arena. I also think this publication will encourage the American public to believe that thoughtful and coherent policies can and will emerge from these disputed matters, in part because of the enterprises of this Council.

I do, though, want to take this opportunity to repeat a point I made during our meetings about the President’s regulatory decision on August 9, 2001, when he permitted some stem cells derived from embryos produced by in vitro fertilization to be used in federally funded research. In essence I see that effort as a prototypic example of an attempt to balance out “conflicts of goods” that can arise with biotechnology regulation.

I hold that President Bush (in trying to respond to concerns that the previous administration’s and Congress’s decisions banning destructive human embryonic research were holding back crucial work) presented American scientists not just with some identified stem cell lines but also with the opportunity to prove their points. Since many Americans (including me) along with governments of other Western nations believe that the use of in vitro fertilization as a source of experimental tissues is seriously problematic, our best scientists could treat the approach offered by President Bush as they might any priority decisions over federal support and funding. They could take the partial support offered at the moment and return to the source after employing that support to develop more compelling data demonstrating what has been accomplished and what is now more clearly in prospect and not to be denied. Anyone who has worked on an NIH grant review board knows and expects just such behavior from scientists who receive less financial support than they requested and a priority score that they find perverse.

I sense from our conversations that scientists resent the idea that in this arena “non-peers”—i.e., people lacking their scientific credentials—are voting on the “priority score” and so may influence the outcome. But not only are other matters in question here than the quality of the science, we are now accustomed to representatives from the public on Institutional Review Boards (IRBs) and hospital Ethics Committees dealing with biotechnology, and we have occasionally celebrated the wisdom these people bring to the enterprises. I think the most helpful and productive stance is to presume that the President’s regulatory proposal is a good-faith effort to define the problems and priorities on the basis of contemporary knowledge as he sees it. Disagreements with him should be supported with new results from the research his proposal permits.

In essence I support the regulations as proposed here and am honored to have had the opportunity with my colleagues on the Council to play a small role in their development.

Paul McHugh


Personal Statement of Dr. Rowley

The latest report of the Council on Bioethics focuses on the ethical issues surrounding aspects of assisted reproductive technology (ART) and the potential misuses of the technology. The report is a review and restatement of previous reports with a relatively complete review of the agencies, government and others, who have an interest in and potential jurisdiction over various aspects of ART. In my view, the report should have done much more to applaud the medical advances that have occurred leading to the effective treatment of an important medical problem, namely infertility, rather than focus primarily on the potential hazards and misuses of the new technologies. In addition, I think it is important to note plainly that some of the major concerns highlighted in the report could be resolved relatively painlessly by changes in current governmental regulation, at the state and at the federal level. I am also disappointed that the report does not call for federal funding of basic and clinical research seeking improved methods of assisted reproduction or for mandated health insurance for ART services. Both of these measures would help to reduce the risks of ART to women and children.

One area of concern includes the lack of comparative data on the outcome of in vitro fertilization (IVF) both with regard to long-term health effects on the women involved and on the children born using the various techniques. Because this is a rapidly moving area of medical practice, meaningful comparisons between older techniques and current practices and the impact of the changes on the success rate (full-term pregnancies) and health of the child are not as complete as one would like. However we are not as ignorant as indicated in the report. There are solid data from other countries with more integrated health care systems that the risk of ovarian cancer is not increased in women using IVF; hyperovulation syndrome is rare (as this report notes, it may be as low as 0.5 percent), relatively easily treated, and mostly occurs if the woman becomes pregnant. Nowhere in the report is it indicated that the risks to women of a natural pregnancy are far greater than the procedures associated with IVF. Adequate federal funding (as recommended) would allow accurate data collection on the effect of ART on the women who have participated and the health and performance status of children born using ART, correlated with the various techniques used in the early stages before implantation. Such data are important, and, as the Council insists in this report, participation in such a longitudinal study should be voluntary, rather than required by law.

In addition, these medical practices are generally not covered by insurance so the costs are born by couples desperate for a biologically related child of their own. This restricts ART to only those families that can afford it. The report criticizes professional societies for inadequate and conflicting guidelines in Chapter 2. In contrast, in Chapter 10, the report says that there are a host of reasonable guidelines in place. Many ART clinics follow the guidelines established by the societies but some (the number is uncertain) flaunt them, apparently with impunity. I believe that having ART covered by insurance would be the most effective means of oversight because if clinics did not conform to agreed upon guidelines, they would not get paid. As shown by a recent study in the New England Journal of Medicine (347: 661, 2002), fewer embryos are implanted in states with insurance coverage for ART and multiple births are one of the major causes of maternal and infant morbidity and mortality. Informed discussions to create guidelines with effective means of enforcement, as well as federal funding in certain areas, are a far more rational route than Congressional legislation. 

The report also sounds alarms about privately funded research, raising the fear that because there are no federal laws regulating research, individuals are free to pursue avenues of research of their own choosing using human embryos. In fact, some of these privately funded researchers have already developed new embryonic stem cell lines that are likely to help advance our understanding of the potential of human embryonic stem cells for better treatment. Allowing these cell lines to be used for federally funded research is required if we are to make meaningful progress.

The report identifies other areas of research that appear to be irresponsible, namely attempts to fuse two species to try to form a human/animal chimera. Such experiments are rare and are unlikely to succeed beyond a preliminary mixing of cells because of the genetic incompatibility of the two species. Other bioethical issues relate to the possible use of preimplantation genetic diagnosis for non-medical indications, especially for sex selection. This is not done by reputable clinics and could be abolished by vigorous oversight. I believe that promoting data collection and availability of insurance coverage would be far more effective than opposing these highly uncommon practices. Some futuristic scenarios discussed in Chapter 3 that consider the prospect of increasing control over the genetic characteristics of children seem to me very far-fetched, and the ethical issues raised are, therefore, not in my view anything to be concerned about.

Providing data on the costs and results of individual clinics is, at first glance, a worthy proposal. Data gathering in this field involves complicated issues of privacy, as well as a need for strict controls in data analysis. For instance, data should be obtained and presented in a manner that reflects the patient population and should include most especially maternal age. Are some clinics willing to accept couples that have failed at other clinics and may be likely to fail again? In other words, are the populations seen at different clinics comparable?

Much of the final part of the report’s description of the options and recommendation is related to concerns for human dignity and what is seen by some as the trumping of this concept by technology. At present there is unanimous agreement that (1) human embryos should never be transferred to the body of nonhuman species or to a human womb except to produce a live-born child and that (2) a child should only be the result of the union of egg and sperm. There is less agreement on how long human embryos should be cultured ex vivo, although current practice is no longer than 14 days.

Yet legislating in this area, even when well meaning, is a tricky and risky business, and there is a danger of overreaching and excessive zeal that could, if unchecked, interfere with sound research and beneficial treatment. There are many other areas of concern that are probably not suitable for being considered as an option for legislation; and although the Council’s final recommendations avoid them, the presentation (in Chapter 9) of possible substantive policy options puts forth dubious suggestions that might seduce the careless or the zealous legislator.  For example, the question of ooplasm transfer is not as clear-cut as it might seem. If infertility is due to defects in maternal mitochondrial DNA, the fusion of the nucleus from her oocyte with ooplasm from a normal donor cell might be a rational treatment. So why ban it? Should there be legislation related to non-disease-related genetic screening? How serious a problem is it in the US? Should we restrict gene therapy in embryos with single gene disorders if it becomes safe? These are all questions that need thoughtful discussion before moving headlong into a legislative ban, and although this report does not call for such bans, some observers and commentators would surely like to enact them. Thus, I am concerned that, despite the limited character of the final recommendations in Chapter 10, Congress might make use of the report’s outline of some possible substantive legislative options in Chapter 9 to do real damage to beneficial research and medical treatment.

In my personal view, what should the Council recommend? In addition to the two items listed above, the top priority is for increased federal funding for basic research to develop the best conditions that will result in healthy babies as well as collecting data on the health of mothers and children involved in IVF. Responsible professional societies and patient advocates should be more forceful in developing comprehensive practice guidelines and then enforcing them. As indicated, universal insurance coverage for infertility would provide a strong lever for such enforcement.

Janet D. Rowley

 

 

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