Page 1       TOP OF DOC
TUESDAY, JULY 22, 1997
U.S. House of Representatives,
Committee on Science,
Subcommittee on Technology,
Washington, DC.

    The Subcommittee met at 2:05 p.m., in room 2318 of the Rayburn House Office Building, Hon. Constance A. Morella, Chairwoman of the Subcommittee, presiding.
    Mrs. MORELLA. I'm going to call to order the Technology Subcommittee of the Science Committee. I'm going to ask our panelists to move forward to the table.
    In the meantime, I welcome all of you. This is the Technology Subcommittee's third cloning hearing. Our first hearing was held in March, and it was the first Congressional hearing on cloning, after the announcement of the breakthrough technology that created Dolly the sheep.
    At that hearing, we determined how cloning technologies are currently being used and will be used in the future for positive scientific advancement, and explored if the technologies can, and should be used for human cloning.
    In July, 3 days after the National Bioethics Advisory Commission submitted its report to the President called ''Cloning Human Beings,'' this Subcommittee held the first Congressional hearing on the report and its accompanying recommendations.
    Today's hearing will discuss the parameters for legislating the prohibition of federal funding for human cloning research.
    I've had the opportunity to peruse the witness testimonies, and while I appreciate our distinguished panel's insights on the broader issue of cloning, the issues before us today and within the jurisdiction of this Subcommittee are whether the Federal Government should be funding research to produce a human clone, and if, not, how should Congress prohibit such federal funding for human cloning research.
 Page 2       PREV PAGE       TOP OF DOC
    I believe that attempting to clone a human being is unacceptably dangerous to the child and morally unacceptable to our society. There should be legislation prohibiting anyone from receiving federal funding for attempting to create a child using the cloning technology that made possible the creation of Dolly.
    This appears to reflect the national, if not a worldwide consensus on the issue. The European Union and several countries, including Germany, Denmark, Australia, Spain, and the United Kingdom, already have laws or are preparing laws to forbid human cloning.
    France, Argentina, China, and Japan have also indicated an intention to deter efforts to clone humans, as well as 20 countries associated with the Council of Europe and the World Health Organization.
    Additionally, at the June G–7 Summit of Economic Countries in Denver, the President, along with the Heads of State for Japan, Germany, England, France, Italy, and Canada, collectively endorsed a worldwide legislative ban on human cloning.
    In achieving that legislative goal, however, it's imperative that we take a well-reasoned and judicious approach to prohibit the federal funding for human cloning research, and by so doing, we can prevent the misuse of cloning technology on humans, while also preserving the potential for future biomedical breakthroughs using that technology.
    As we all know, there are many agricultural and medical benefits that can be derived from cloning technology, including the development of medicines and therapies for diseases such as cancer, hemophilia, cystic fibrosis, sickle cell anemia, and emphysema, among others.
    Additionally, cloning technology furthers our knowledge about developmental biology that may one day lead to such advances as the repair and regeneration of human tissue in severe burns and spinal injuries.
    These scientific and biomedical advances have the great potential for saving lives and substantially improving our quality of life. This research and development must not be inhibited by any legislative actions that we undertake.
 Page 3       PREV PAGE       TOP OF DOC
    So the challenge we face is both simple and complex. We all want to prohibit the federal funding of human cloning, but how can we legislate its ban without creating unintentional adverse impacts upon the research and development of biomedicine, biotechnology, and genetic therapies. This is the question that's before our distinguished panel.
    Our first witness is Dr. Hessel Bouma, a Professor of Biology at Calvin College in Grand Rapids, Michigan.
    Father Kevin Wildes, a Professor of Ethics who is the Associate Director of the Kennedy School of Ethics at Georgetown University here in Washington, is our second witness.
    Dr. Arthur Haney is the Director of the Department of Endocrinology and Infertility at the Duke University Medical Center in Durham, North Carolina, and is also the President-Elect of the American Society for Reproductive Medicine.
    Dr. Haney and our other two witnesses represent scientific associations and industry groups that may utilize cloning technologies in their research and development.
    Representing the biotechnology industry organizations is Dr. Alison Taunton-Rigby, who is the President and Chief Executive Officer of Aquila Biopharmaceuticals in Worcester, Massachusetts.
    Our final witness is Dr. Lester Crawford, the Director of the Center for Food and Nutrition Policy at Georgetown University, and the Vice Chairman of the National Association for Biomedical Research.
    I'm very pleased to welcome all of you to the Technology Subcommittee. I look forward to working with you to craft proper legislation to prohibit the federal funding of human cloning research.
    I'd now like to recognize our distinguished Ranking Member, the gentleman from Tennessee, Mr. Gordon, for any opening remarks that he may wish to make.
 Page 4       PREV PAGE       TOP OF DOC
    Mr. GORDON. Thank you. I want to join Chairwoman Morella in welcoming everyone to this hearing on recommendations on a legislative prohibition of federal funding for human cloning research.
    As Chairwoman Morella stated, this is the third hearing that the Subcommittee has held on this topic, and we now have an appreciation for the difficult and complicated topic.
    Almost everyone in this room would agree that using federal funds for research on cloning a human being is wrong.
    The issue for Congress is to decide if legislation is necessary to enforce such a prohibition. If legislation is necessary, we need to ensure that we don't craft a law of unintended consequences, that useful research isn't banned along with research on cloning a human being.
    In order to do this, we have to rely on the scientific research community to provide us with the facts surrounding cloning research, and the appropriate language that will meet Congressional intent. If not, we run the risk of doing more damage than benefit.
    I want to welcome our witnesses appearing before the Subcommittee today, and I look forward to hearing your recommendations.
    Mrs. MORELLA. Thank you, Mr. Gordon.
    I'd now like to recognize Mr. Ehlers for his opening statement.
    Mr. EHLERS. Thank you, Madam Chairwoman, and thank you especially for conducting a hearing on the bill which I introduced sometime ago. I deeply appreciate it.
    My comments will be by way of introduction to the bill and related to the bill. As you know, I introduced the bill shortly after the cloning of Dolly the sheep, or at least the announcement thereof.
 Page 5       PREV PAGE       TOP OF DOC
    I found it interesting that a number of scientists immediately raised the question of whether we should have legislation, and suggested that it wasn't necessary.
    I found it very interesting that the National Bioethics Advisory Commission, which contained a number of scientists who told me that legislation was not necessary, in fact, when they gave their final report, stated very clearly that federal legislation should be enacted to prohibit anyone from attempting, whether in a research or clinical setting, any child through somatic cell nuclear transfer cloning.
    And they further conclude that at this time, it is morally unacceptable for anyone in the public or private sector to attempt to create a child using somatic cell nuclear transfer cloning.
    We can worry a bit about the definition they use, but we won't get into those fine points right now.
    When discussing it with some of the scientists on that Commission who had previously said legislation wasn't necessary, they simply said that as a result of the deliberations of the Commission and the testimony they received, they had decided that, in fact, it was necessary to have legislation.
    I would also like to point out that the bill regulates only human cloning, the creation of a human embryo. Implicitly, and close to explicitly, the other purpose of the bill is clearly there, and that is to allow plant, animal, microbial, cell, and human tissue cloning, all of which are very important for research, the type of research that you mention in your opening statement, Chairwoman Morella.
    I think it is extremely important to ensure that goes forward. Part of the reason for introducing the bill was to ensure that research could go forward, because I heard some immediate cries to ban all cloning.
    I'm also aware that state legislatures are looking at this and also making similar comments. So I believe we can set the pattern for the Nation and perhaps render state legislation unnecessary by passing an appropriate bill here that makes it clear that the only cloning that we would consider prohibiting is that relating to the creation of a human embryo.
 Page 6       PREV PAGE       TOP OF DOC
    I've also tried to keep the bill very straightforward, very simple, and restricted to legitimate governmental interest and not overstep our bounds on that score.
    I did not include a penalty in this particular bill. It is implicit, however, because anyone violating the restrictions on spending incurs penalties under the general laws of the United States.
    The bill is, to the best of my ability, simple and straightforward. I have a revised draft out today, which I have developed as a result of discussions with a number of scientists and some ethicists, and, I think, clarifies a few points and a few definitions.
    I am very willing to continue to work with those interested parties who still have concerns about the bill, about the definitions or the intent, and try to achieve a version of the bill which addresses concerns as soon as possible.
    One issue I did not address at all—and I have received a number of letters requesting that I address this, and that is the issue of patents, intellectual property rights. The letters I have received have suggested that the bill should ban allowing anyone to obtain a patent on the cloning process.
    I have decided not to include that, but I am willing to listen to others present who may think it is appropriate for us to address that.
    The National Bioethics Advisory Commission suggested a 5-year sunset. Rather than that, in the substitute version of the bill which I am proposing, we're building in a 5-year review by the National Research Council.
    I would be quite happy to also have the Bioethics Advisory Commission do the review, however, they go out of existence in less than 5 years, unless we insert in the bill reauthorizing them for a continued period of time.
    As I say, I did not include any state preemption. I always, as a former state legislator, am very reluctant to include state preemption. I don't think it's really necessary because I believe if we pass this bill, then States will simply decide there's no longer a need for them to pass state legislation, and, therefore, the passage of this bill would make state legislation less likely.
 Page 7       PREV PAGE       TOP OF DOC
    I believe there are, and I suspect Dr. Bartlett would agree with me on this, that there are constitutional questions of our preempting the rights of States to pass their own legislation on this particular issue.
    I do thank the panel for their interest and for attending. Madam Chairwoman, if I may, I'd like to request permission at the appropriate time to introduce Dr. Bouma, since he is from my district.
    Mrs. MORELLA. Indeed, so, Mr. Ehlers.
    Mr. EHLERS. Thank you very much.
    Mrs. MORELLA. I'd now like to recognize Ms. Rivers from Michigan for any opening comments she may like to make?
    Ms. RIVERS. I have no opening statement.
    Mrs. MORELLA. I recognize you as being here. I appreciate it.
    Now, my distinguished colleague from Maryland, Dr. Bartlett.
    Mr. BARTLETT. Thank you very much, and thank you, Madam Chairwoman, for convening this panel of witnesses.
    I'm in a somewhat peculiar situation since I'm the only—as far as I know, the only experimental biologist. I'm a human physiologist with a doctorate in that, having taught medical school. So I'm the only person with this kind of a background in the Congress.
    Congressman Ehlers mentioned the suggestion we ought to ban all cloning. I would suggest that would be a little difficult, since we have a good many thousands of clones produced each year.
    Identical twins are, of course, clones. You can make a choice as to which one is the original and which one is the clone. But clearly this is an act of cloning by nature. It occurs in the womb, and I suggest that it would be very difficult to ban this cloning.
 Page 8       PREV PAGE       TOP OF DOC
    I'd also like to suggest that we talk about cloning in the context of the cloning which nature produces naturally in animals and humans, and that is the identical twinning. These are clones.
    I know several identical twins. None of them feel that they are less a person because there is another individual with exactly the same gene complement.
    I know of no one who thinks that our society is diminished because we have identical twins in our society. And yet when we talk about laboratory cloning, we have exactly those concerns; that is that the clone would be considered and would consider himself or herself less a person, and that society would somehow be diminished.
    I would hope that we would reflect for awhile on the need for legislation and the consequences of legislation. I know that this discovery in Scotland which resulted in Dolly, captured the attention, if not the imagination, of people all around the world.
    And when something as momentous as this happens, there is always a concern among the public as to the consequences of this kind of activity.
    So I want to thank you, Madam Chairwoman, for convening this panel, and I would hope that with their expert testimony and the expert testimony of those panels that have already been convened and those that probably will be convened in the future, that we take an opportunity to reflect soberly on this very important subject of whether or not legislation is needed.
    I hope that we're able to put it in the broader context of cloning which occurs naturally in nature. Thank you very much.
    Mrs. MORELLA. Thank you, Congressman Bartlett.
    I'd now like to recognize the distinguished gentleman from Texas, Congresswoman Johnson.
    Ms. JOHNSON. Thank you very much, Madam Chairwoman. I appreciate you having this hearing.
 Page 9       PREV PAGE       TOP OF DOC
    On rare occasions, I associate myself with remarks made by the previous speaker, and now I do with our distinguished gentleman that represents NIH.
    I do have some concerns. I am not pro-government funded human cloning research at this point, but I do have a concern about getting too restrictive on the research, because I firmly believe in research.
    We've gained so much from research on humans and animals as well. There's so much yet to be learned, and I don't want to reflect in any way with my support of this ban, my displeasure with the results of research that we have gained in this country and throughout the world.
    I will listen with interest to some of the testimony, but also do wonder about banning privately funded research as well. I just have some concerns. I am not firmly in place as to where I would necessarily come down if I was questioned about whether I supported human cloning or not.
    But I do have grave reservations about cutting off any opportunity for research where we can gain very useful information for the future of our own human kind. Thank you.
    Mrs. MORELLA. Thank you, Congresswoman Johnson.
    I'm going to ask the panelists that if you would kindly rise and raise your right hand, because it's a policy of this Committee, the Science Committee, to swear in those who are testifying.
    [Witnesses sworn, en banc.]
    Mrs. MORELLA. I will now introduce Dr. Ehlers who will introduce the first person who is going to be testifying.
    Mr. EHLERS. Thank you, Madam Chairwoman. It's a pleasure to introduce Dr. Hessel Bouma, Professor of Biology at Calvin College, which happens to be my alma mater, and also the institution where I taught for 16 years.
 Page 10       PREV PAGE       TOP OF DOC
    We overlapped only a few years, but I was impressed with Dr. Bouma as soon as he arrived. As you can tell, he's somewhat younger than I am, but he arrived just a few years before I left to enter the political arena in the Michigan Legislature.
    He quickly made a name for himself, but interestingly enough, he made an even broader name for himself in the community around the college, and, in fact, has achieved some national recognition for his work in bioethics.
    He has spent a good deal of his time on that, as well as his research in biology and is highly regarded in both fields. I am pleased that he was willing to take the time to be with us, and to offer his views on this topic.
    Mrs. MORELLA. Thank you, Mr. Ehlers, that was a nice introduction.
    Dr. Bouma, I'd like to turn to you now. I'm going to ask each of you if you would try to confine your testimony to 5 minutes, and then we'll have an opportunity for questions and answers. Thank you.
    Dr. Bouma?

    Mr. BOUMA. Thank you, Representative Morella, Chairwoman of this Subcommittee, and Vern Ehlers for the invitation to be here, for the invitation to participate in this hearing on human cloning.
    I speak not as a representative of any particular organization or institution, but as an individual who is a scientist, bioethicist, parent, and citizen with significant moral concerns about the possibility of human cloning.
 Page 11       PREV PAGE       TOP OF DOC
    I am a deeply committed Christian, a Protestant in the Reform tradition, but the moral and ethical concerns I express here today are not uniquely religious in nature.
    Human beings are unique, whether this emanates from an understanding of our species as pinnacles of evolution or created image-bearers of God as in the Judeo-Christian tradition.
    We recognize our personal and relational uniqueness and seek to provide special protection for humans. Human life elicits special awe and respect, even reverence.
    While we emphasize human freedom, we agree to limit some of that freedom when the freedom of one comes at the expense of another. Human cloning significantly threatens this uniqueness, respect and freedom.
    An overwhelming majority of people believe human cloning ought not to be done at all, or can be justified in only a few rare situations. To protect the interests of the public and human well being, human cloning should not be left as a new reproductive liberty, nor solely as professional guidelines with voluntary compliance.
    We need government restrictions on the possibility of human cloning. Restrictions on human cloning need to be clear.
    First, what constitutes human cloning? It should not preclude animal, plant, or microbial cloning, which are done routinely today, are quite beneficial, and for which we have carefully crafted an effective regulating legislation.
    Nor should it preclude the cloning of human genes or human cells which also are done quite routinely, or the future possibility of cloning human tissues and organs, which are highly desirable and may be achievable without the moral onus associated with the cloning of human persons.
    Second, what constitutes human cloning? Human cloning currently refers to the creation of multiple individuals from a single individual through embryo splitting, embryonic cloning and adult cloning. To result in children who are clones, all three of these must progress through gestational development with a surrogate mother.
 Page 12       PREV PAGE       TOP OF DOC
    Legislation must address, is it permissible to experiment with the initial stages of this process without intending to provide an opportunity for implantation? If so, to what extent?
    A ban on the use of federal funds for research on human cloning can be one effective means of restricting human cloning. It is warranted, but insufficient.
    If we can agree that under all or nearly all circumstances, human cloning ought not to be done, then government restrictions are warranted on the privately as well as the publicly funded sectors, and we should work to achieve this consensus in restrictions, not just nationally, but internationally, as well.
    Because of the significant moral and ethical concerns, any legislative effort to ban or regulate human cloning should be accompanied by sufficiently clear and severe penalties to make it unlikely that anyone will be tempted to violate the legislation.
    Such penalties should be a deterrent to those few who would ignore professional guidelines or a voluntary moratorium. Scientists, whose judgment can be impaired by a technological imperative, we can/we must, to supporting institutions to the wealthy and seekers of fame and fortune.
    It even, as far as is possible, should be a deterrent to persons who would undertake this endeavor offshore. The current temporary moratorium on human cloning affords us the time to develop careful legislation.
    The National Bioethics Advisory Commission has given us a remarkably quick and excellent start on focusing the issues. Now our task is to design a more permanent legislative ban or regulation.
    Given the dramatic developments which can occur in science, NBAC and many others suggest this legislation should be subject to automatic review in several years. If so, legislation should shift the burden of proof for human cloning from those who would restrict it to those who would condone it.
 Page 13       PREV PAGE       TOP OF DOC
    Laws are not unchangeable. In the absence of compelling reasons to lift a ban or restrictions, or to establish exceptions, they should remain in force.
    Thank you for the opportunity to participate in this important hearing.
    [The prepared statement of Mr. Bouma follows:]
    Insert offset folios 1-5

    Mrs. MORELLA. Thank you. I think you had almost 1 minute left. Very good.
    Father Professor Kevin Wildes.

    Mr. WILDES. Thank you, Madam Chairwoman.
    My name is Kevin Wildes, and I am the Associate Director of the Kennedy Institute of Ethics at Georgetown University. I am also an Assistant Professor in the Department of Philosophy and in the Department of Medicine at Georgetown.
    I am also, as you might be able to tell, a member of Society of Jesus and a Roman Catholic priest. However, I testify here today, not as a theologian or a priest, but as a philosopher with a specialty in bioethics and health policy.
    Since February 23rd of this year, there has been a good deal of public discussion on the topic of human cloning. Like many ethical and scientific discussions, it has taken place with varying degrees of sophistication and knowledge, as well as with misinformation and a wide variety of opinions.
    The discussion is only beginning. Nonetheless, the National Bioethics Advisory Commission concluded that there exists a strong moral consensus at this time that, ''It is morally unacceptable for anyone in the public or private sector, whether in research or clinical settings, to attempt to create a child using somatic cell nuclear transfer cloning.''
 Page 14       PREV PAGE       TOP OF DOC
    The NBAC report clearly documents that there are profound moral concerns about human cloning. The arguments and the reasons are detailed; they are powerful, and they are numerous.
    There are ethical concerns about physical harms of cloning, about its effects on our understanding of the human family and individuality, its effects on social values, about how it will affect our allocation of resources and our research priorities, and of, course, there are eugenic concerns about the uses of cloning.
    These are just a few of the headline concerns that are thoroughly discussed in the NBAC report. Our discussion today, however, is about the appropriate or inappropriate use of federal money to support research in human cloning.
    What is important is that we must recognize that science, and medicine, in particular, are not developed within a vacuum. We have lived in this century, a century that bears witness to the moral evils that flourish when science is treated as pure research and as value-free.
    The work of Nazi researchers or the work of our own public health agencies investigating radiation or syphilis are stark reminders to us of when science and medicine move outside of the moral fabric of any given society.
    Many things have been done in the name of science with the intention of promoting good and making the lives of future generations better than the present. However, such reasoning often overlooks the ethical questions of whether or not one can ever do an evil so that good may come.
    The moral questions of human research have been some of the central questions that have defined and developed the whole field of bioethics. The funding of research, I would argue, is a moral question as well as a budgetary one.
    The question about public research is not simply a questions of what individuals may choose or not choose to do with their own lives, which is often the case with moral questions.
 Page 15       PREV PAGE       TOP OF DOC
    Rather, this question is fundamentally a question about who we are as a Nation and the types of activities we want to support. Health care and medical research are in large part sustained and directed by the large investment of public resources.
    Medical education, research, health care institutions and programs are all underwritten by direct and indirect allocation of public resources. In light of the limited moral authority of a secular government and in view of the broad consensus that nuclear transfer cloning is morally unacceptable, there seems to be no moral grounds to justify the use of federal funds in any way for human cloning research.
    The question about the best means to control such research funding is, in fact, in the end, your area of expertise, not mine. Legislation is clearly an option that can be used.
    While I recognize with NBAC that there are difficulties in writing legislation in this area, I do agree with NBAC and their conclusions that federal legislation should be enacted in this area. However, as with any legislation, I often would caution that we must seek to be as clear and precise as possible in all of its language and definitions.
    Furthermore, any legislation in these matters will have to have some built-in review mechanism. The ethical issues of science develop and change rapidly. This is something we often miss.
    There will need to be an ongoing review and discussion in all of these areas, and I hope that any legislation would have some built-in mechanisms for review and discussion.
    I am convinced that we are only at the beginning of a whole set of ethical issues that will be with us for generations to come.
    I want to thank you for allowing me to be a part of this discussion.
    [The prepared statement of Mr. Wildes follows:]
 Page 16       PREV PAGE       TOP OF DOC
    Insert offset folios 6-12

    Mrs. MORELLA. Thank you very much, Father Wildes.
    I'd now like to recognize Dr. Arthur Haney.

    Dr. Haney. Thank you, Madam Chairwoman. Thank you for holding this hearing and inviting us to participate.
    This Committee's thoughtful leadership on this issue has been noted and appreciated by those of us in the medical and scientific communities.
    My name is Arthur F. Haney. I'm a Professor of OB–GYN and the Director of the Division of Reproductive Endocrinology and Infertility at Duke University Medical Center.
    However, I speak to you today as the President-elect of the American Society for Reproductive Medicine, a national professional organization whose members are dedicated to advancing knowledge and expertise in reproductive medicine, as well as treating infertility.
    Let me say from the outset that ASRM finds unacceptable, any attempt at cloning an existing human being. At this time, there is no clinical, scientific, or moral justification for it.
    As scientists and physicians, one of our highest values is the freedom of inquiry that the scientific method demands. We are therefore extremely reluctant to support any legislative efforts to curtail that freedom.
 Page 17       PREV PAGE       TOP OF DOC
    Nevertheless, there are times when government prohibitions, carefully and thoughtfully developed, are appropriate. At this time, human cloning merits such prohibition, not just in federally funded research, but more generally.
    However, it is vital that any cloning prohibition, but particularly research prohibition, be drafted with extreme care using precise language when defining what it is you wish to prohibit.
    I would offer the following definition for the kind of human cloning we would all agree should not be allowed: Human cloning means the duplication of an existing or previously existing human by transferring the nucleus of a differentiated somatic cell into an oocyte in which the nucleus has been removed, and implanting the resulting product for gestation and subsequent birth.
    This language will stop what should be stopped without curtailing other promising areas of research which might lead to advances in reproductive medicine. We would urge that this be the only prohibition.
    Congress should accept the recommendation of the National Bioethics Advisory Commission and do nothing that would endanger the advances made possible through the use of cloning human cells and tissues and the cloning of non-humans.
    We also support the Commission's call for the inclusion of a sunset provision in any such legislation. We would ask you to include a preemption clause to ensure that individual state legislatures do not undo what has been done at the federal level.
    Finally, we would urge that this Committee work not only to enact a thoughtful prohibition on a very limited research act, but explicitly work to lift existing prohibition on the use of federal funds for blastocysts and embryo research. All of these elements should be included in any legislation.
    Our hope would be that a prohibition on the cloning of existing human beings would help alleviate public concerns. Once Members of Congress and the public at large are assured no one is attempting to create copies of themselves, perhaps our attention can then turn away from science gone awry, and return to the business of improving human health.
 Page 18       PREV PAGE       TOP OF DOC
    The first IVF baby was born 19 years ago. Since then 55,000 IVF children have been born to infertile parents in the United States, and IVF is now a standard treatment for many types of infertility.
    Had the fears of 20 years ago halted research, those families would still be childless. However, this is not the success story it should be.
    Most recent advances in the field have taken place outside the United States. As a result of 20 years without federal support and guidance, the United States lags behind many other countries that support carefully restricted in vitro fertilization research.
    We believe the techniques and methods involved in this research, as considered within the broader spectrum of blastocyte research have merit because they can provide fundamental knowledge to aid in the treatment of infertility and genetic disease.
    More than 5 million couples are infertile. Thanks to medical advances, we are able to treat more of them every day.
    Unfortunately, there are still too many we cannot help. A carefully drafted cloning prohibition will work to assure the public of the two things they desire: First, the research that will help build families continues, while, second, preventing the morally repugnant attempts to duplicate and existing or previously existing person.
    We hope the Committee can lead Congress by crafting any legislation in such a way that it will support the public's dual goals and strengthen its commitment to promising areas of research in reproductive medicine.
    Again, I thank you for the opportunity to appear before you, and I look forward to answering your questions.
    [The prepared statement of Dr. Haney follows:]
    Insert offset folios 13-21

 Page 19       PREV PAGE       TOP OF DOC
    Mrs. MORELLA. Thank you, Dr. Haney, for that testimony. I'd now like to recognize Dr. Alison Taunton-Rigby.

    Ms. TAUNTON-RIGBY. Madam Chairwoman and members of the Subcommittee, thank you for the opportunity to appear here today to outline the position of the Biotechnology Industry Organization with regard to bills pending in the Subcommittee on the use of somatic cell nuclear transfer.
    I'm a scientist, and I will talk to you today from that point of view. My goals and those of other scientists who are involved with biomedical research are to develop new, safe, and effective drugs and diagnostics for the host of diseases which afflict mankind.
    We are using the tools of science, biology, chemistry, genomics, et cetera, to unravel the causes of diseases. While we've made remarkable progress in the past few decades, there are still so many serious intractable diseases which face us.
    BIO members and their companies are not interested in cloning human beings. We will abide by the President's moratorium.
    This is because we're not in the business of creating babies. We are in the business of using creative research to better the lives of people.
    We urge the Subcommittee to proceed with extreme caution on the issue of somatic cell nuclear transfer. We must make sure that nothing is done in terms of legislation that will adversely impact vital biomedical research and inhibit the abilities of our scientists to develop new, effective treatments.
    There is a real danger that a poorly drafted bill could inadvertently wreck havoc on important research. We must be extremely careful to avoid unintended consequences.
 Page 20       PREV PAGE       TOP OF DOC
    I'd like to help you understand this issue. I've referred to the technology in question as somatic cell nuclear transfer.
    You may prefer that I use the word cloning, but cloning simply means producing an identical copy. It's an essential process used in virtually all genetic engineering research.
    We've been cloning cells, genes, and molecules for almost 20 years. Cloning of cells and genes has proved to be the cornerstone of biotechnology's ability to develop new drugs and diagnostics for intractable diseases.
    It is a critical technique used to make human insulin for diabetics, Activase to dissolve blood clots, Epogen to treat anemia due to kidney disease, and much more.
    The Nation's blood supply is safe today because biotechnology tests are used to screen every unit of blood.
    Biotechnology holds the promise of much more to come. There are few areas where we have not made much progress.
    One of these areas is the process whereby genes and cells are switched off and on. In cancer, some genes that control cell division are switched on when they should be off.
    The cells grow too rapidly and a tumor results. In contrast, some cells, when damaged, will not grow again and regenerate themselves.
    Nerve cells are like this. When someone suffers a spinal cord injury, we do not know how to repair the damage. We cannot get the proper genes to switch on.
    I'm telling you this so that you may understand why Dr. Wilmut's cloning of an adult sheep is an encouraging research step.
    Many of the genes in adult cells are switched off. The cells are differentiated. But Dr. Wilmut developed a technique to reprogram the genes in an adult cell and get them switched on again.
 Page 21       PREV PAGE       TOP OF DOC
    That is how Dolly was made. The fact that Dolly exists proves that genes in the somatic cells used in her creation were reprogrammed. It allows us some hope.
    Let me explain the term, somatic cell. As many of you know, our cells contain 2 copies of each of our 23 chromosomes, with the exception of the X and the Y chromosomes.
    These cells are called somatic cells. Somatic cells are diploid cells; that is, they contain two copies of each chromosome. In contrast, germ line cells such as X and sperm cells contain only one copy of each chromosome.
    In each of us, one copy of each of our chromosomes was derived from our mother and one from our father.
    One of the wonders of having children is the mixing of genes from two parents. That is what makes each of us special and unique.
    With Dolly, all of the chromosomes, both copies, came from one adult sheep. A somatic cell was used in Dolly's creation, rather than two germ line cells, an egg and a sperm, each with one copy of the chromosomes.
    The nucleus from the somatic cell was removed and injected into an egg cell which had its own nucleus removed. Thus, Dolly was created using somatic cell nuclear transfer, and she is a genetic copy or clone of her mother.
    The technique of somatic cell nuclear transfer is a very useful research tool, but we believe that it is very wrong to use this technology to create a child.
    It's the application of the technology which is wrong, not the basic technology itself. Let me state emphatically that BIO agrees with the conclusions of the National Bioethics Advisory Commission, that it is unacceptable at this time for anyone in the public or the private sector, whether in research or clinical settings, to create a human child using somatic cell nuclear transfer technology.
    This application of the technology may raise ethical and societal social issues regarding a diminished sense of individuality and personal autonomy.
 Page 22       PREV PAGE       TOP OF DOC
    In addition, we believe this technology is not currently safe for use in humans, thus, there are a serious fundamental steps in the technology which need understanding through research on animal cells.
    My testimony includes an outline of our analysis of the legislation proposed by the Clinton Administration, by far the most sophisticated of the bills that have been proposed.
    If the Subcommittee determines that legislation must be enacted, at a minimum, the proposed bill must be substantially revised. The National Bioethics Commission cautioned in its report that it's notoriously difficult to draft legislation at any particular moment that can serve to both exploit and to govern the rapid and unpredictable advances of science.
    We've identified 12 issues in the draft Administration bill. The first and most serious issue is that this and other pending bills do not use scientifically accurate terms, even of such key terms as somatic cell nuclear transfer and cloning.
    We are able to provide you with the latest of many drafts of our written recommendation regarding an appropriate definition of somatic cell nuclear transfer, but more work may be required.
    That it is not as simple, is evidenced by the fact that we have nine different definitions on the table; one in the Administration's bill, three in the NBAC report; one in each of the bills proposed by Congressman Ehlers and Senator Bond, and one in the discussion draft of the Subcommittee of June the 18th, and one in testimony of the Association for Reproductive Medicine.
    Many of these definitions are not accurate from a scientific point of view. They are either imprecise, over-broad, or both.
    We are proposing language that meets the recommendation of NBAC, does not inhibit vital biomedical research, is not subject to misinterpretation, and is complementary to the existing legislation on the use of federal funds.
 Page 23       PREV PAGE       TOP OF DOC
    The following definition covers the type of cloning, human cloning, that we all agree should not be allowed. We believe that it should be unlawful for any person to use federal funds for the creation of a human being using somatic cell nuclear transfer technology.
    We define somatic cell nuclear transfer technology as transferring the nucleus of a somatic cell from an existing or previously existing person into an oocyte from which the nucleus has been removed, and implanting the resulting product for gestation and subsequent birth.
    Somatic cell means a differentiated diploid cell. We believe this prohibition and definition meets all of the recommendations of NBAC to stop the creation of human beings with this technology, and at the same time allow other vital research to proceed.
    The definition of this term is quite critical, as it defines the science which is the subject of the statute. Without a precise and scientifically accurate definition, no one will know what science is covered.
    If the bill uses terms which scientists do not understand or which are not accurate from a scientific point of view, the statute will not communicate to the key audience scientists.
    In addition, the unintended consequences will be the regulation of vital basic research. I'm talking about research that could lead to understanding cell differentiation, understanding graft rejection, development of cell-based therapies, the ability to regenerate tissues lost to disease and injury, specialized cells such as pancreatic cells for diabetes, brain cells for spinal cord injuries, neural cells for patients with Parkinson's Disease, even maybe Alzheimer's and the regeneration of liver cells and bone marrow cells.
    I'd also like to make some other recommendations and observations on the best course of action. First, the legislation should focus only on the technology at issue, the use of somatic cell nuclear transfer technology to create a human being.
 Page 24       PREV PAGE       TOP OF DOC
    Second, we believe the legislation should focus only on research funded by the Federal Government, and third, the legislation should not, as does the Administration bill, focus on the intent of a researcher. We are concerned that this will lead to unpredictable explorations of the psychology of researchers.
    Fourth, we recommend that a mechanism be established to enable scientists to secure advisory opinions from the NIH, the Institute of Medicine, National Science Foundation and other bodies which have expertise in these issues as does the private sector.
    Fifth, the legislation should include a sunset provision as NBAC recommends and the Administration had done in its proposed bill. NBAC states that a sunset provision is absolutely needed to assure an opportunity to reexamine any judgments made today because as the scientific information accumulates and public discussion continues, new judgments may develop and we as a society need to retain the flexibility to adjust our course in this manner.
    Sixth, the legislation should include a preemptive revision. It is vital that we handle this complex issue on a national basis, not with 50 different state bills which vary widely in scope and quality, and which could seriously harm local research effort.
    One state bill already drafted attempts to ban the cloning of human DNA, which would undermine all biomedical research in that State.
    Finally, the legislation should also include a finding section, a section defining protected research, and a prohibition on private rights of action.
    In conclusion, we wish to express our appreciation for the care with which NBAC and the Administration have considered the issue, and the obvious concern which they have both shown to ensure that no action is taken and no bill is enacted which will undermine vital biomedical research into cures and therapies for deadly diseases, and research into infertility and birth defects.
 Page 25       PREV PAGE       TOP OF DOC
    We commend the Administration for its efforts to convert the NBAC recommendations into statutory language. This effort helps to focus the debate and highlights the complexity of the tasks.
    Thank you very much, and I'm happy to answer your questions.
    [The prepared statement of Ms. Taunton-Rigby follows.]
    Insert offset folios 22-73

    Mrs. MORELLA. Thank you, Dr. Rigby. We did give you extra allocation of time because you had enormous testimony. I hope you all know that the testimony you've submitted, in its entirety, goes into the record, even though you may not have orally articulated it all.
    And now I'm pleased to recognize Dr. Lester Crawford.

    Mr. CRAWFORD. Thank you, Madam Chairwoman.
    I am here today as the Chairman-elect of the National Association for Biomedical Research Board of Directors.
    Like the other scientific organizations from which you have heard, NABR agrees with and supports the conclusions and recommendations made by the National Bioethics Advisory Commission, or NBAC in its June 1997 report.
    Madam Chairwoman, it is understandable that an awesome achievement, such as the Scottish experiment in sheep previously discussed can cause some degree of apprehension in the American public.
 Page 26       PREV PAGE       TOP OF DOC
    What is not right is for the public's reasonable fears to be exploited by hyperbole. To this end, we in the research community must devote more attention to educating the public.
    With more reliable information, people would be prepared to separate legitimate science from science fiction.
    Unfortunately, in addition to some irresponsible tabloid-type reporting on the subject of cloning, we have seen several radical groups try to recruit Dolly, the sheep, for their own propaganda purposes.
    One such group staged an anti-animal research demonstration during the NBAC proceedings. The agenda of those few who would stop animal research in any way possible for any reason whatsoever must not cloud the important issues before you.
    The Commission supported continuation of the essential and responsible use of animals in biomedical research. And NABR is confident that you will do the same in considering legislation regarding human cloning.
    More than this, NABR believes that the constructive hearing you and the Subcommittee are conducting will help alleviate needless apprehension and still encourage the best science.
    The public expects research risks to be addressed while research benefits continue. Great progress in medicine and biotechnology is possible using new genetic techniques without entering the realm of cloning human beings.
    Genetically engineered mice have already revolutionized our ability to study devastating diseases such as breast cancer and immune system deficiency.
    Even better animal models for human disease aiding research into new and improved therapies are an exciting prospect stemming from the latest cloning methods.
    The most immediate benefit is likely to be the faster, more efficient production of therapeutic human proteins in the milk of transgenic farm animal species. These drug products of biotechnology have already aided persons with blood deficiencies and serious infections, among other conditions.
 Page 27       PREV PAGE       TOP OF DOC
    In the longer term future, cloned animals might become a safe source of organs for transplantation in patients with heart, kidney, or liver failure.
    Studying the somatic cell transfer process itself in animals and human tissue, never approaching the actual cloning of a human, can also provide other long-awaited answers.
    For example, so-called somatic mutations, that is to say, mutations that take place in adult human and animal cells that are not inheritable, can cause tumors and other illnesses.
    Cellular changes of this type are also a part of the aging process. Looking at the way cells undergo those sorts of mutations could help us better prevent cancer and avoid the negative effects of growing old, such as Alzheimer's disease.
    Ultimately, greater understanding of somatic cell differentiation might lead to the ability to regenerate or repair living tissue damaged by a variety of diseases including spinal cord injury.
    In veterinary and agricultural research, cloning techniques may benefit animals directly either through improved medical treatments or by preserving genetic strengths.
    Rather than limiting genetic horizons, new technologies may help us preserve biodiversity and ensure the continuation of rare individual animals or endangered species, too many of which are in need of protection today.
    In summary, NABR believes that science and government have shared responsibilities. These duties are especially relevant to the national policy question now before you.
    Together, we must reassure the public that:
    Number one, science will not pursue research results which society is morally and ethically unwilling to accept;
 Page 28       PREV PAGE       TOP OF DOC
    Two, research is being facilitated and the rewards of research can be enjoyed because of safeguards that are in place to protect humans and animals in experimentation; and
    Finally, existing laws and regulations are being followed and periodically reviewed to keep pace with new technologies.
    Madam Chairwoman, NABR applauds you and the Subcommittee for seeking a sound science policy regarding human cloning, and trusts that in determining that policy, you will promote responsible life-saving research.
    NABR would be pleased to provide any assistance you may need in the future to be certain that legislative proposals do not impede research requiring animals.
    Thank you once again for the opportunity to express our views and for your interest in these issues.
    I welcome any questions you or other Subcommittee members might have.
    [The prepared statement of Mr. Crawford follows:]
    Insert offset folios 74-79

    Mrs. MORELLA. Thank you, Dr. Crawford.
    Thank all of you for your testimony.
    I did want you to know that I have some written testimony from some other organizations which will become part of the record, and other groups have an opportunity within the next 5 days to submit any statement they might like to make about the issue.
    I really want to get to the real guts of the issue. Namely, if you could give me—first of all, if you've had a chance to review particularly Congressman Ehlers' bill, the one that was referred to this Subcommittee to this Committee, the Science Committee, and if you have, what your comments are about what can be done to make it acceptable to you and one that would serve the Nation well.
 Page 29       PREV PAGE       TOP OF DOC
    He has offered an amendment in the nature of a substitute which does some clarification of some terms.
    I'm not sure you all have it. I guess that's why I'm posing it that way. But if you do, I'd very much like your opinion.
    This Subcommittee has been asked to consider a markup of the bill and we want to make sure we get adequate input with clarifications, specificity where necessary, so that this complex issue can be crafted into acceptable legislation.
    That is the premise if you think there's legislation that's even necessary.
    So I guess I could start with anybody who would like to begin on that.
    Dr. Ehlers, I thought I'd get right to the issue.
    Anybody want to begin on that?
    All right, great, Dr. Rigby.
    Ms. TAUNTON-RIGBY. I'd like to make a couple of comments on some language that I received yesterday, H.R. 922. I assume that is what you're referring to?
    Mrs. MORELLA. Yes, it is.
    Ms. TAUNTON-RIGBY. I took a look at this and, you know, I've only got some pieces of what is in this bill. My overall impression that it's very broad language and subject to misinterpretation as a result.
    Much of the language talks in fact about, you know, even the title, Human Cloning Research. It's not the act of cloning a human being but it's research in the title.
    The prohibition uses the language to not use any federal funds for any project of research that involves the use of a human somatic cell to produce an embryo.
    My interpretation of that language is it's actually directed more at embryo research than the Wilmut type of cloning, which is what we are here talking about today.
 Page 30       PREV PAGE       TOP OF DOC
    So it goes beyond what NBAC recommended. It goes beyond what the President put in his language. It also, in my mind, covers issues which today are largely covered by existing legislation on embryo research.
    Congress has already debated that and spoken up on embryo research.
    I also have concerns when you have a definition that covers technology other than somatic cell nuclear transfer, that it may actually inadvertently exclude practices that are important for treating infertility and for managing birth defects.
    Reproductive research is very, very important.
    And most importantly, I think it will exclude a lot of the vital research on tissue regeneration and repair.
    We need to be able to work with cells and with single cells to be able to do that type of research. So those are concerns when I read that language.
    Mrs. MORELLA. Do you think that, I know BIO has been working on this. I'm very cognizant of the fact that it's gone through many different drafts.
    Do you think that you could submit to this Subcommittee your specific suggestions on a bill that you would consider to be not only acceptable but that would move the process forward in terms of achieving what NBAC and the President and all of us want?
    Ms. TAUNTON-RIGBY. We could. And I have a copy of it here, and we could submit it to you.
    I can read you the language that we put in which is equivalent. We put in two sections.
    Section 3 Prohibition. It shall be unlawful for any person to use federal funds for the creation of a human being using somatic cell nuclear transfer technology.
    Then a definition, the creation of a human being using somatic cell nuclear transfer technology means transferring the nucleus of a somatic cell of an existing or previously existing person into an oocyte from which the nucleus has been removed, implanting the resulting product for gestation and subsequent birth.
 Page 31       PREV PAGE       TOP OF DOC
    Our language is actually very similar to the language that Dr. Haney proposed. So it's actually quite remarkable that we've come up with, from a different perspective, come up with very similar language.
    What is important is the source of that somatic cell. It's a person that exists already. That differentiates twinning, for example, which is a concern of Mr. Bartlett.
    It actually limits it to the Dolly-type of cloning that was done. That's what we have to focus on.
    Mrs. MORELLA. Thank you.
    Dr. Haney, do you want to pick up on that? Would you agree with what she said about your recommendations being similar?
    Dr. HANEY. Yes. Ours are virtually the same. I'm not sure, I wasn't listening to every word, but we would have phrased it as:
    It will be unlawful for any person to use federal funds to engage in human cloning.
    And then for the definition is for the purposes of this section, human cloning means the duplication of an existing or previously existing person being, by transferring the nucleus of a differentiated somatic cell into an oocyte in which the nucleus has been removed and implanting the resultant product for gestation and subsequent birth.
    I think the intent to implant and produce a child is the critical issue.
    Second, is somatic cells as opposed to gametes. And I think ours are virtually the same.
    Mrs. MORELLA. What do you think, Father Wildes?
    Mr. WILDES. It strikes me, and this is something where I would want to look at the language much more specifically within all the context.
    One of the things I would point out, it strikes me whenever we're looking at definitional issues, it's not just when you define something at that moment, but it's how the surrounding context of the language and where that gets developed.
 Page 32       PREV PAGE       TOP OF DOC
    Because often we determine meanings from things when we interpret things, not only from definition as stated in paragraph number one, but how that gets used throughout a text.
    So it would be important to look at that throughout the entire language.
    I think everybody's sort of getting at sort of this trying to balance a very difficult set of issues.
    On the one hand, the large agreement, the widespread agreement we want to prohibit human cloning and the use of federal money to support human cloning.
    On the other hand, not to draw the language in such a way that we wind up undermining other necessary research that we think is both good and necessary.
    Mrs. MORELLA. Thank you.
    Dr. Bouma?
    Mr. BOUMA. My reservation is that I think there still is a lot of ambiguity in the language that has just been proposed.
    You hear in there a phrase of existing human being or person, and unless you define what you mean by that, it has not added a great deal of clarity.
    There certainly is within our society individuals who will say that four to eight cell embryo is an existing human being or a person. There are others who will say, no, that only occurs after birth.
    And so without clarifying between those, there still is ambiguity there, and if it is drawn or defined conservatively, it would preclude what both panelists are advocating in terms of permitting embryonic or fetal cloning, but not adult cloning.
    And so there still needs to be greater clarity there and I wish you all the wisdom in the world in trying to define existing human being and person.
    Mrs. MORELLA. In a noncontroversial manner of course. Right.
 Page 33       PREV PAGE       TOP OF DOC
    Dr. Crawford, would you like to add to this?
    Mr. CRAWFORD. We just got this language. Obviously we'd be glad to evaluate it and make input.
    Our principal concern, however, is that in your efforts to prevent human cloning, that other forms of biomedical research not be adversely affected.
    And that is the principal reason we're here.
    Mrs. MORELLA. Thank you.
    I wanted to turn it over to my colleagues for any questioning they may have, but I want to also recognize the fact that we've been joined by Ms. Stabenow, who was here for most of the testimony from Michigan.
    Mr. Gordon?
    Mr. GORDON. Thank you.
    We also have time limits, so I want to ask one question and then let all of you that would like, or any of you that would like to respond to do so, and again recognizing the time limits here.
    Having read or as familiar as you are with H.R. 922, as well as familiar as you might be with the President's or the Executive's current prohibition on research, as well as the statutory prohibition in the Labor/HHS Appropriations bill, do you have any thoughts as to whether or not this bill does anything that is not already in the Executive Order or not in the appropriations language?
    Does anyone have a comment on that?
    Ms. TAUNTON-RIGBY. What is in the Administration's bills already on the appropriations language in fact only covers human embryos, and it does not in fact uncover the type of cloning, the Wilmut type, which is from, while I recognize it's hard to define, but an existing or previous existing human being.
 Page 34       PREV PAGE       TOP OF DOC
    The language that is in there is reasonably tight, but is not as tight as it could be. And that's why we have debate on an issue like this.
    I think what we have to do is craft language which complements what's already in the Administration's Appropriations bill language because that has been well-debated and we shouldn't get into that debate again because it's a tough one.
    We've got those guidelines and we've got that bill language, and we work with that.
    What we have to do is have something that stops the Dolly-type of cloning happening in humans. And so the critical thing is not to have simple phrases. You've got to put phrases together, it's got to be an existing or previously existing person. It's got to be a differentiated somatic cell and it's got to involve implantation, because that's a bright line that says implantation into the womb and creation of a person in that way.
    Mr. GORDON. Well, with that statement as a benchmark, would anyone like to agree or disagree?
    Yes, go right ahead.
    Dr. HANEY. I would certainly agree, and I would emphasize again the implantation and birth. That truly separates the research areas that will be exploited, as opposed to the implantation and birth, which is the morally repugnant portion.
    Mr. GORDON. Anyone else like to make a comment?
    [No response.]
    Mr. GORDON. Let me also ask you, what are your suggestions as to enforcement, legislative enforcement?
    Mr. BOUMA. I've already suggested that I think there is a need for there to be some penalties attached. Certainly forfeiture of existing funds would be one reasonable sort of penalty.
 Page 35       PREV PAGE       TOP OF DOC
    The existing penalty on the other companion bill is a civil penalty of about $5,000. In the fertility industry, that's a drop in the bucket.
    I think that there needs to be some substantial penalties, not because I believe that even a majority of scientists are going to go against whatever legislation is enacted here, but I do believe that the temptation will be there for a few individuals because of a lot of reasons that they might see private gain from it.
    But I think there ought to be some penalties attached to denote the fact that we consider this a very serious moral issue.
    Mr. GORDON. Anyone else want to?
    Mr. EHLERS. Will the gentleman yield?
    Mr. GORDON. Certainly.
    Mr. EHLERS. I checked this out and I would agree with Dr. Bouma that the penalty on the other bill, House Bill 923, which deals with the general prohibition, should be strengthened.
    I deliberately did not put penalties into this bill because there are already penalties in law for anyone who misappropriates funds that are appropriated by the Federal Government. It's a minimum $5,000. There's a jail term involved and also, if it's a research grant, they are liable to return up to double the amount of the total grant if they've misused funds contrary to the law.
    Mr. GORDON. So it would be a penalty plus fines.
    Mr. EHLERS. Penalty plus fines plus potential jail time. So that's covered in other parts of the law.
    Mr. GORDON. Would anyone like to comment further now that we have that benchmark what your thoughts would be?
    Too much? Too little? Different way?
 Page 36       PREV PAGE       TOP OF DOC
    Mr. CRAWFORD. I believe that if you take that construct, that they are in violation of rules and penalties, and that rules and that penalties are called for in that regard, then it's well covered.
    In other words, if they are breaking the law with regard to proper appropriation of federal research funds, then you certainly have adequate penalties if you can transfer that intellectually.
    Mr. GORDON. Thank you.
    Mrs. MORELLA. Now I'll turn to Dr. Ehlers for his line of questioning.
    Mr. EHLERS. Thank you, Madam Chairwoman. And let me just clarify. Staff has just informed me that the felony portion of the penalty applies only to federal employees who misuse appropriated funds.
    The $5,000 plus return of up to double the amount of the research grant will apply to any researcher.
    I have a number of questions, and I doubt if I can get them all in in 5 minutes.
    But I was somewhat surprised when—and I did read your testimony, Dr. Rigby, virtually all of the testimony, and I noticed that you were quite critical of the bill written by the President.
    And I'm surprised that the bill language you're working on now, and that you quoted, is based almost entirely on the President's bill and a number of sections of it are word for word.
    That bill has not been too highly regarded in the Congress. In fact, not one single Congressman has introduced the bill, to my knowledge, and so it's still out in limbo land.
 Page 37       PREV PAGE       TOP OF DOC
    One of the disadvantages, I think, is its length. And when you're dealing with a subject like this, there are serious advantages to being concise, which is precisely why I tried to keep mine as short as I did. I probably kept it too short.
    The substitute's a bit longer and clarifies things a bit more, and I'm willing to work with you to try to clarify it more yet.
    But I am puzzled. Why did you decide to use that as the working draft and proceed from that rather than work with the bills that have already been introduced?
    Ms. TAUNTON-RIGBY. I think I can understand your argument that a longer bill may have too much in it, but also a short bill, by excluding things that you want to make absolutely sure are free and clear to do.
    For example, you should point out what research you are free to do, and some of that is missing from some of the other bills.
    So we took the starting point of the most comprehensive bill to be able to address all the issues that might come up in that. And it's a bill where it could be fixed. There are some issues with it that do need correcting.
    All of the bills that are there could be fixed. But you can start where you've got most of it present and try and work on that, which is what we did.
    Mr. EHLERS. Let me just point out some of the dangers, and I'm speaking from the governmental end or the political end.
    If you provide a list of things you may do, then by implication, things which are not on the list, you can argue you may not do. And therefore it's dangerous to put in a list of things you may do.
    For example, our speeding laws, we say thou shalt not go over 65 miles per hour, whatever. We do not say you may go 65 miles per hour because that implies it's illegal to go 63 miles per hour.
 Page 38       PREV PAGE       TOP OF DOC
    This is a long history of English law as opposed to some of the European laws which tend to be of the permissive type. Ours are of the restrictive type.
    And those terms do not mean precisely what I said. A fascinating example is when I saw it some years ago in Europe. In America, when you see a sign that says, please stay off the grass, quite often when I was walking through Europe, it said stay on the path. There's a totally different approach there in these two bills epitomize that difference of approach.
    It's important to say precisely what you may not do, and it's often better left and not give a list of the things you may do.
    Yes, Dr. Haney?
    Dr. HANEY. At the risk of having physicians and attorneys at conflict——
    Mr. EHLERS. I'm not an attorney, by the way. I'm a physicist.
    Dr. HANEY. Wonderful.
    I guess the reason we're here is a fairly unpredictable scientific event. And I would simply point out that most of the science that has progressed in the latter part of this century have been fairly unpredictable events, and I, for one, am extremely uncomfortable having some insight into what's going to be out there, what's in the future.
    And I'm not arguing for necessarily length, but if the bill does not have in it the opportunity to anticipate the unanticipated, I think we have serious trouble because you just cannot know where science is going to be in 3 to 5 years. It's very difficult.
    Mr. EHLERS. That's absolutely true. And let me point out, the bill is intended to be dynamic. In fact, the law itself should be dynamic rather than static.
    And I specifically put it in the 5-year review for that reason.
    It seems to me that the basic dilemma we have here is not so much the concern over definitions. I think we could agree on some common definitions.
 Page 39       PREV PAGE       TOP OF DOC
    I think the real issue is the one that we see right at the table here with two members arguing great concern about research in the embryo and three members saying we'll only talk about implantation or creation, as Dr. Rigby said, I believe that implantation is a bright line.
    Maybe it is for you and maybe it is for NBAC. It's not true for the majority of the Congress.
    And I think that's one basic dilemma that we're just going to have to vote on that one and see where the votes are in this Congress. But I think I know where it'll come out.
    But that aside, I think our efforts should be to try to pin down the definitions as precisely and carefully as possible, because it is my intent to maximize the freedom to conduct research with the restriction of human embryo research and human cloning research as we may define that.
    The intent is not to put undue restrictions on you, and certainly nothing beyond what I think is absolutely essential in terms of the discussion of the first two gentlemen on the panel.
    So the question is how can we best do that.
    My time is up so we may have a second round.
    Mrs. MORELLA. Well, it gives them a chance to think about it too.
    Ms. Rivers, I'm pleased to recognize you.
    Ms. RIVERS. Thank you, Madam Chairwoman.
    Following up on something that Dr. Crawford said, that this hearing should alleviate needless apprehension and make sure that the best science is applied to this issue.
 Page 40       PREV PAGE       TOP OF DOC
    I want to go back not so much to what you were talking about today, but sort of the premises that this whole debate is based upon. Because in the last hearing that we had, we heard from the Committee that did work on this. And there were several proposals put forward or several assertions put forward that I don't think were fully discussed at that debate and I think remain part of this debate, and I'd like to talk about it.
    The first one is while I recognize that there are potentials for errors as this process gets used, one of the arguments that got put forward is that there was the potential, if this were done with human beings, there's the potential for maladjustment for psychological damage to any resulting children.
    And I asked at the time that we have some experience now with in-vitro fertilization, and is there any evidence at all to suggest that children who are conceived through non-traditional means suffer from any long-term damage, whether it's self-esteem, whether it's they are mistreated by their families or their neighbors or their society at large.
    And, Dr. Haney, I'm curious. This is an area that you're expert on.
    Is there any indication that we've had a problem with that with the IVF kids?
    Dr. HANEY. I think the data is very secure with IVF children that they have no different psychologic profiles than children conceived the natural way.
    And I would even say that virtually ovulation induction, even donor insemination, all of the traditional methods, the children who are produced have no psychological differences as long as they have the same problems with single parenting or parents or families. It's all the same. I have no concern about that.
    Ms. RIVERS. All right, good.
    Professors Bouma and Father Wildes, in your comments, there was sort of this suggestion that by pursuing human cloning, we would somehow, as human beings, lose our awe of life or that we would somehow diminish the value of life.
 Page 41       PREV PAGE       TOP OF DOC
    And I'm curious, is there any suggestion in our history or where we are right now whether we're looking at whether families parents unmarried or unmarried, whether it's IVF, whether we're talking about instances of conception during rape or incest, is there anything in our society today that suggests were a child produced through these nontraditional means, that it would cause us, as a Nation, to feel less respectful of life in general, or to devalue in any way the individual?
    I mean we've got experiences out there now of situations that society has not accepted in the past but seem to be handled pretty well now.
    What makes you feel that there would be some diminishment because that's something that comes up all the time in this debate and I never heard anybody articulate it exactly why.
    Professor Bouma?
    Mr. BOUMA. Yeah, I'll take a first shot at it.
    I think that it's accounted for fairly well in the NBAC report where it talks about this opens up a whole new possibility in terms of having a truly single parent individual where a woman now could have a clone of herself using one of her eggs and one of her somatic nuclei that are transferred into that egg.
    That's very different than anything that we have done before. In in vitro fertilization, you still have a random sort of event of a sperm and an egg coming together from two different individuals.
    This adult cloning is entirely different. Even embryonic cloning would be to take a blastomere and maybe say 16 cells, you could theoretically take out 16 nuclei, put them into 16 eggs, and instead of having twins or triplets or quadruplets, I don't know what the word is for 16 off the top of my head right now, but that's in theory what you could have.
    I think that is a very significant sort of thing. It isn't like we're doing low hurdles or high hurdles. We're doing the high jump and it's not like it's a bar where we can see on the other side. It's a wall and it isn't——
 Page 42       PREV PAGE       TOP OF DOC
    Ms. RIVERS. Right. I can understand that it's different, but the question that I'm asking is why would you assume that it would be less? That people would respond to it in a less, with less awe than they do when a child is born under regular circumstances, or would somehow see less value of life in general?
    That's what I'm trying to get to, is how you get from different to less than.
    Mr. BOUMA. I think it would be instead that one has this component of genetic determinism that now this is a special expectation that we put upon this individual that we don't put upon anyone else.
    We may create that on our own, but here because of the genetic identity that we already know is a consequence of the donor of the somatic nucleus, we would also have that expectation, if you cloned Michael Jordan and he turned out to be a pianist, would you be disappointed?
    Ms. RIVERS. Well, and isn't that of course one of the things that gets overlooked in this whole debate is the fact that genetic determinism isn't going to lead us to the same sort of person that in fact that even though the genes may be identical, that the nature versus nurture issue is much greater and that the times are different, the experiences are different.
    And so actually that was going to be my next question is because we also get this argument that one of the problems in the whole cloning debate is the arrogant immortality that would, as somebody said, well, you're basing your definition on the duplication of existing or previously existing persons, when in fact we know from the studies, the impact of environment that the likelihood of being able to duplicate any existing person or pre-existing person is not high.
    Is that right, Dr. Haney?
 Page 43       PREV PAGE       TOP OF DOC
    So why would that be a definition when?
    Dr. HANEY. I don't think that's a definition of the outcome. I don't think that's a definition of the college you go to or the career you necessarily chose, but I do not think we have any evidence historic—the reason, I mean, in dealing with this in contrast to identical twinning where they start the same and have different nurturing, you're dealing with individuals in generational twinning.
    Ms. RIVERS. Right.
    Dr. HANEY. And I'm not saying there's data there, but I would certainly not like to embark upon that as a clinical enterprise.
    Ms. RIVERS. Which is one of the things that I notice in the popular press is this perception that cloning a person means you produce a carbon copy who acts the same, reacts the same, does everything like the Patty Duke Show that used to be.
    And I think that has led people, as I said, to this view that there's this arrogant immortality aspect and that people are, very rich people are somehow planning to find a way to perpetuate themselves.
    Let me speak, and I know I didn't get back to you, Dr. Wildes.
    Are we going to have a chance for a second round?
    Then I'll go back to Professor Wildes.
    Mr. WILDES. I'll just go back to both. I think you're absolutely right about some of the public misperceptions on this issue. But if I would with one quick overview of what's the moral concerns behind this.
    I think it's—and I'll pick up on some language that you used, and in fact that Dr. Haney used about production. I think the moral concern has been we look upon human beings as, whatever language one might, with awe, unique, et cetera, whatever, mystery and often religious language comes here.
 Page 44       PREV PAGE       TOP OF DOC
    One question though is if we begin to use a technology to produce someone, are we going to start looking, will we start looking at a class of human beings as somehow in fact less than human; but in fact our property, our production.
    I think this has long been a deep moral problem for civilization in the west in particular. One only has to think of the way the United States Government used eugenics policy at the beginning of this century, immigration policy to control populations and the kinds of people that were allowed or now allowed in.
    One only has to think back to the last century, and the issues of slavery where human beings were looked on as products and property.
    Ms. RIVERS. Do you see anything like that happening around the IVF procedure where it is a procedure where families are being helped to get what they want very much which is a child.
    Mr. WILDES. Right. I think—let me just state and here I began by saying I was speaking—let me do a flip on this as a priest who has worked with couples who have had children.
    I think there is always a potential danger, and Dr. Haney can speak more to this, when couples have difficulty with the IVF process. Sometimes they can be—I've seen couples begin to look on this, not just as a child they want, but as an obsession within their life.
    That's a risk that's there, sure, I think. But it's not a dominant, I don't think it's necessarily dominant.
    Ms. RIVERS. Than that leads them, their obsession to have a family leads them to devalue the child once it's born?
    Mr. WILDES. I think there can be a tendency and here I speak simply out of my pastoral experience such as it is, there can be a tendency to begin to look upon the wanted child as another object within the life of a couple.
 Page 45       PREV PAGE       TOP OF DOC
    Ms. RIVERS. Dr. Haney?
    Dr. HANEY. I don't believe there's any evidence that the children produced as IVFers, if you want to use that word, or assisted, I think is a much better word that when medical experts assist couples have children, that those children have any different value than if they spontaneously were conceived.
    And if anything, I would have probably argued the reverse, that those children are probably more highly valued for the effort that their parents had to go through to have them. And it's not enjoyable, it's not inexpensive, it's not pleasant but it is clearly the entire discipline that I work in is patient-driven.
    It is not driven by the physicians asking patients to come to our door because you need children. It is patients coming because of the inherent feeling I need to reproduce and be a parent, and the humanity that confers upon us to have children who then abuse us and keep us up at night and make us pay their college bills.
    Ms. RIVERS. Mine wrecked my car yesterday.
    Dr. HANEY. Yes.
    Dr. HANEY. All those good things that make us all humans. And to deny people that opportunity to be parents because somehow we would treat them differently because they needed assistance to get there I think belies the reality.
    Ms. RIVERS. Okay. Thank you.
    Thank you, Madam Chairwoman.
    Mrs. MORELLA. I'd like to recognize now Congressman Bartlett. I have been generous in the time for the questioning because it's been really pretty critical that we get your responses to some of these critical questions.
    Mr. BARTLETT. Thank you very much.
 Page 46       PREV PAGE       TOP OF DOC
    I'd like for a moment to continue the just previous line of questioning, the notion that a clone would be less than human because it has the same gene structure as another person.
    Is there any evidence that identical twins feel less than human, or that they have a diminished humanity, or that they are considered so by others?
    Ms. TAUNTON-RIGBY. I'm not an expert on this area, but I'll give you, as a mother of four children, my response to that. You still don't know when those identical twins are first born what they're going to grow up into, what they're going to be like, what their personalities are going to be like.
    And so there's the sense of wonder is exactly the same. You have no idea how that child is going to grow up and what sort of human being they're going to be.
    And it's your job as a parent to educate them and try and teach them morals and ethics and values.
    If you clone a human being from DNA from an existing person, you'll inevitably have a conception in your mind as to what that child is going to turn out into. And you're going to say, well are they going to be as good as, are they going to be just as good an athlete, are they going to be as bright as, or can we correct the mistakes that this other person made in their life.
    So you're going to alter the freedom of how that child will grow up and the criticism that they will be subjected to. They are not as unique an individual as a pair of twins are because we don't know what those twins will turn into.
    So to me, they are very, very different.
    I come at it from another perspective. I think that to clone a human being using this technology as it stands today is totally unsafe and it's for the safety reasons that I think NBAC came down saying we should have a law against this because it is not safe to use this technology in humans.
 Page 47       PREV PAGE       TOP OF DOC
    Mr. BARTLETT. That argument was a very strong one used in a previous panel.
    Setting aside all of the ethical issues, as we now perceive them, they had some very serious concerns about safety and about the morality of using this technique considering the safety.
    I understand the expectations for a child like this, but in fact, would not a clone be less like the donor than individual twins would be like each other because they would be a generation at least some years apart and would have a totally different nurture?
    You see, there is a common feeling that this would be an exact replica, just a duplicate, and that in fact is not true. Is that correct?
    Ms. TAUNTON-RIGBY. That is correct, but I think that still leaves the expectations on that child conceived by this method. It's the watching, the looking. You're not going to treat that child exactly the same as you would treat two twins because they are a generation apart.
    That is sort of untenable to think of somebody with that burden on them.
    Mr. BARTLETT. This places an additional burden on any clone that might be produced, I would admit.
    All of you cautioned, I think, that we need to move slowly, we need to be very careful of that language which is adopted does what we want to do, and does not do something other than what we want to do.
    There is now a moratorium on the use of federal funds. I do not know whether that is causing problems in the research community or not.
    If it is not causing problems, I think there is wisdom involved in having a discussion be widely engaged in the private sector.
    And this is just one of those cases where I think that the more the private sector is involved, and the more extensive the debate is, the better job we will ultimately do of drafting legislation.
 Page 48       PREV PAGE       TOP OF DOC
    If there is no current critical need for legislation, I would hope that the debate could continue so that the ultimate legislation which is drafted will do exactly what it needs to do and not have some of the potential side effects that you all are concerned about.
    Let me just make a couple of comments which you may or may not want to respond to.
    I'm now about three-fourths of a century old, and so perhaps I can be permitted to be a bit politically incorrect, if that's okay.
    One of the things I would like to suggest is that as desirable as legislation as we think it is here, there is potentially a constitutional issue here. We live in a republic, we do not live in a democracy. It's not appreciated by many of our people. And I hear too many of our leaders talk about this great democracy.
    We in fact live in a republic. A republic is a rule of law, not a rule by the majority.
    And the laws that we pass are constrained by the Constitution.
    I remember in my past experience, the episode where Harry Truman solved a major national problem. The steel mills were going to strike. We already were in economic trouble, and Harry Truman, in his usual take-charge style, fixed that problem. He nationalized the steel mills.
    The steel workers were now employees of the Federal Government, and as such, they could not strike. And so the strike was averted and this was a very popular action.
    The Supreme Court met in emergency session and in effect what they said was, Mr. Truman, no matter how popular that action is, you can't do it because it's not constitutional.
    I think we need to be very cognizant of the fact that we live in the longest enduring republic in the history of the world, and that's because we have jealously guarded the Constitution.
 Page 49       PREV PAGE       TOP OF DOC
    I think that whatever law we draw up needs to be drawn consistent with the Constitution, which can be changed, by the way, if we need to change it; two thirds of the House, two thirds of the Senate vote, and then it goes, bypasses the President, and goes to the States and three-fourths of their legislatures must ratify it.
    But until that is done, I think that whatever law we draw up must be consistent with the Constitution.
    I agree with Congressman Ehlers that, as I read the Constitution, no matter how desirable it might be to have a federal law which preempted all state laws, I'm not sure, Vern, that that's constitutional.
    So I would caution that we need to make sure that whatever we do is consistent with the Constitution that has served us well. I think that it serves us less well if we violate it.
    The other observation I would make is, if I could stand back, sometimes if you kind of emotionally put yourself a million miles out into space and 50 years down the road in the future, and then look back, some things take on a different perspective when you do that. I have kind of done that relative to this issue.
    Obviously, any clone would be really wanted. It's very difficult, it's very expensive, very time-consuming. And while we are opposed to permitting this one clone—we probably ought to, considering the temper of our society today—I contrast that with the fact that each year, we terminate the life of roughly a million and a half preborn.     And I think this is just an interesting observation, that we are so concerned about the potential creation of one new life, and we apparently have little concern for the roughly million and a half lives that are terminated each year.
    Thank you, Madam Chairwoman, for convening this meeting. I think that it's very important to have these discussions, and I have really been impressed by the breadth and scope of the testimony, and the answers to questions by the staff. And thank you for your leadership.
 Page 50       PREV PAGE       TOP OF DOC
    Mrs. MORELLA. Thank you, Mr. Bartlett.
    Now, Ms. Stabenow, I'd like to turn to you for any questions you may want to proceed with.
    Ms. STABENOW. Thank you, Madam Chairwoman.
    This is a very difficult issue we're grappling with, a lot of very thoughtful comments and testimony today, which I appreciate very much. I would start on the lighter side by stating that when you were describing parenthood, it makes us all wonder if we need mental health help, as we all wish to have these children that keep us up all night.
    So, as much as they are blessings, what I struggle with—one of the things I struggle with the most is how we enforce what we're talking about here, in terms of not having human cloning. It's been spoken to a little bit, but I guess from my perspective I need more input and help as to how, when we pass a law saying that this is illegal to be doing this, who would be enforcing this? How do they enforce this?
    I think there are some incredibly difficult issues that arise around issues such as coming upon cloning that's already occurred or in process. I remember discussing in our state legislature issues around reproduction, where someone posed to us, what if you come upon a lab with a hundred Petri dishes that have been fertilized, eggs that have been fertilized? If you throw those out, what is that? Is that abortion? Is this life? All of the issue that surround how we come to this in terms of enforcement and what we do if we come upon someone who has begun this process.
    I'd like to have someone speak to those issues.
    Ms. TAUNTON-RIGBY. What's in most of these proposed bills that I've seen right now is limiting federal funds. I think there are many ways that you can enforce the limitations of federal funds. The simplest is withdrawing those funds and making them be paid back if someone does not do that. But the much more tricky question is controlling what happens in the private sector.
 Page 51       PREV PAGE       TOP OF DOC
    There are inspections that are required of in vitro fertilization clinics. There are some limitations on what those clinics may do. But it's an area where you bump into another right, the right of an individual to reproduce.
    That's why I'm not sure there are ways that you can enforce legislation like this, when you impact upon the private use of funds and someone's private reproductive rights. So I think it's more important that we focus on what we're talking about here, which is the use of federal funds, because that is enforceable. That is a route that we can manage this research.
    I should also say that the biotechnology industry actually does not do any of this type of research, and has no federal funding involved. But we already went out right on day one, saying that we would follow the President's moratorium on this type of research. Moratoriums have been very effective ways of dealing with these tricky issues, because it's very easy for us to all say we think it's morally wrong to clone a human being using this technology.
    And in our industry, we've stopped many times. We have a history right from day one, when the first recombinant DNA technology arose 20 years ago. The first thing we did was a moratorium while we understood what we were doing, and then we proceeded cautiously. And we have a history of that.      When the first in vitro fertilization child was conceived and born, there was a pause and there was thinking about it. And I think that is an effective way of dealing with some of these tricky issues.
    So I don't think that we should rush to legislate. I think we should take the time to think it through, and I think you will even see that in the public press. You will see there was an immediate cry in the newspapers, banner headlines with all sorts of horror scenarios that were largely not possible. But now there's a much more thoughtful process going on, and we should encourage that.
    Ms. STABENOW. Yes?
 Page 52       PREV PAGE       TOP OF DOC
    Dr. HANEY. I'd like to make one other hopefully relevant comment.
    Engagement, I think, is part of this process. One of the things that did not happen with IVF in this country is engagement. There was a prohibition, and the Federal Government lost its leadership role, did not direct the research, did not direct how things would evolve. And hence, they have evolved in the private sector, by and large, away from the scrutiny and public discussion you're having today.
    And I would certainly think that this is an area that certainly encourages us to get the Federal Government involved in the process. You simply can't ban research. You need to engage and understand it and deal with it. These kinds of issues are out on the floor and much more easily dealt with than what we're grappling with today.
    Ms. STABENOW. That's an interesting thought, though.
    If we're not providing any federal funding, then it becomes all private sector engagement, as opposed to engaging with individuals within the government, if the public sector funding is eliminated. You're suggesting that it be done all in the private sector?
    Dr. HANEY. No, no, not at all.
    What I'm suggesting is, as a historically similar event, in vitro fertilization was not funded in the public arena. You did not have NIH grants to capable investigators going through IRBs, going to the NIH and getting moral, if you will, ethical and scientific approval to proceed on an experimental basis, et cetera.
    That did not occur. And as a consequence of denying that, then it forced any patient-generated pressure to take the research to the private sector. And this body lost control of the process. And you're seeing the fear, I believe, to some extent of society in having that occur yet again.
    I think the society clearly would like, the public would like to have control of the process. And if you simply do not—not human cloning, but don't get involved in embryo research, ban human cloning and get involved in embryo research. So the next level of scientific inquiry, if it doesn't involve the Federal Government, you're going to no longer have control of that, either. And some other issue is going to arise just like this, and you'll have another call for legislation.
 Page 53       PREV PAGE       TOP OF DOC
    If you were involved in the process—that's why we would strongly encourage you to lift the ban on embryo research, have it occur in public, have it occur with NIH approval, have it occur with high-quality IRB approval in an experimental mode so people are not exploited. Progress is made on a clearly patient-driven issue.
    Ms. STABENOW. Thank you.
    Ms. TAUNTON-RIGBY. Can I just add a comment to that?
    You know, federal funding is peer-reviewed. People have to write grant applications. They have to write what they know about what they're planning to do, what other people are doing. They have to write descriptions of the research that they're planning to do, and then when they want their grant renewed next year, they have to write a report what they did with the federal money.
    It's a process that is subject to an intense peer review. And when you ban the use of federal funds, you put it into some other hands, where you have no way of knowing what is going on. That is not good. We're actually better allowing federal funding for research—not the act of cloning a human being, but let the research go on in a very public fashion. And the most public fashion is to use federal funding for it.
    So I would almost argue the reverse, that we should let this technology be done under federal funding, because then we'll get the disclosure. Then we'll know what's going on, and we'll get the benefits of the research as well.
    Ms. STABENOW. Thank you.
    Mrs. MORELLA. Thanks, Ms. Stabenow.
    We'll start our second round of questions, probably our second and last round of questioning. I'll just ask one question at this point.
    I note that BIO has a Section 6, preemption of state laws. I wonder if you all might comment on how important that concept is, to preempt—have federal legislation preempt any state laws which imposes on individuals or institutions using federal funds a prohibition or limitation with respect to research.
 Page 54       PREV PAGE       TOP OF DOC
    That whole concept of preemption—is it important? How important is it if it is? If anyone would like to comment on that.
    You know, I note that we've previously had somebody mention—Dr. Bartlett mentioned the constitutionality of it, too. I'd like to have that perhaps be included in your thought processes for a response.
    Yes, Dr. Rigby?
    Ms. TAUNTON-RIGBY. One of the reasons we feel very strongly that preemption should be in there—and I do respect the earlier comments. But historically, some issues like the family have been left to States.
    The very discussion that we're having, and the difficulty of defining what it is that we're trying to do—imagine if that happens in 50 different States with 50 different versions. In the back of the NBAC report, they listed a whole long list of bills that already had been put forward. None of them were consistent. All had different language. And a patchwork quilt means that then people would go to one State to get something done. They'll go to a different State for something else.
    There are laws governing interstate commerce. So this is an absolute instance where it's very important to have a clearly defined legislation, if we're to have it, that in fact covers that.
    I would add on the comment of constitutionality, you've touched a little bit on one, which is the right of an individual to reproduce. But I also find I have, as a scientist, another ethical issue that comes to my mind.
    If there is some research that is well-thought-out, that is backed up by a lot of research work that has been peer-reviewed, and it's research that might help a disease where we have no treatments, then I as a scientist think that there's an ethical obligation to carry out that research. It's very important that we cover the constitutional right of individuals to do research as well, within the limits of it being well-thought-out and peer-reviewed.
 Page 55       PREV PAGE       TOP OF DOC
    So there are many issues that we have to pick up here. But we need a consistent one message, one story. Otherwise, we'll end up with misinterpretation of this information.
    Mrs. MORELLA. I'd be interested in the comments that any of you who would like to offer, particularly if you have differing views, or else if you just want to affirm the statement that she made.
    Dr. HANEY. ASRM keeps track of state legislative efforts, and we have at least seven ongoing, and they are extremely diverse. I think it would be very uncomfortable to have the Federal Government absolve itself of decision making and have, as she alluded to, a patchwork quilt appear.
    These are very different laws. And if the language here is imprecise, it is going to be very imprecise or different in state legislatures.
    Mrs. MORELLA. Any other comments on that?
    [No response.]
    Mrs. MORELLA. I'm going to turn it over to Mr. Gordon now for any questioning.
    Mr. GORDON. Thank you.
    Ms. Rivers wanted to continue on her line of questioning. I'll just pass the ball on over.
    Ms. RIVERS. Thank you. I do have a couple more questions, and one is to follow up on something we started on earlier, and actually others have added to, and that's the whole issue of the research going on in the private versus the public arena.
    Also, the whole idea—I said half-jokingly at some point this fear that there are rich people out there who are going through various machinations because they want to perpetuate themselves. What is less funny, but probably more probable, is that if this is all done in the private arena, as opposed to the public, that any procedures that come out of this research could in fact end up costing more to the ultimate consumer.
 Page 56       PREV PAGE       TOP OF DOC
    And particularly, I'm concerned about issues of fertility, spinal cord problems—these are areas where people have projected that we can see progress in the very near future. One of the concerns that I have is that the private sector, in many cases, exists because they hope to commercialize whatever science they do, and actually make money for it. Whereas, if something is done in the public sector, that information becomes available for the broader good.
    I would like people to comment on that. Are we giving up something in this area by pushing the debate and the research out of the public arena into the private arena, leaving it to private scientists and private funding to do this work, and then ultimately to control whatever scientific good comes out of it? Dr. Rigby, you work for a private enterprise.
    Ms. TAUNTON-RIGBY. I work for a public biotechnology company, which is slightly different.
    But work in in vitro fertilization clinics is very, very private. In fact, there is not that much sharing even of information between them. I was asking a physician today if he knew if certain procedures that are done in animals are done in humans. We didn't have a clear answer, because it's kept very quiet.
    What happens in those clinics is, those who can afford it will go and get that treatment, that therapy. If you want something to be available for all people, then it has to be in the public domain. So I think it is much better to have the work done in the public domain.
    The concerns that I have are not so much on the unintended consequences on infertility research and reproduction, but things like spinal cord injuries, where that type of research will never happen in the private sector in these clinics. That sort of research that's going to lead to new medicines and new treatments, regeneration of tissue, organ transplantation, et cetera—that needs to be done in the public sector, and it needs funding behind it. And there's enormous benefit to the research that will come out of it.
 Page 57       PREV PAGE       TOP OF DOC
    Ms. RIVERS. Does anyone else want to comment on that? Dr. Bouma?
    Mr. BOUMA. Basically, I have advocated that whatever applies on federal funding limitations, we should also see if we could extend it, that we limit it for private work as well; that the ban ought to be extended broader than just to federally funded research.
    I do think that the discussion can go forward. I am absolutely convinced that this cloning research is going to go forward in animals, and that it will be constantly raised through federally funded research. And questions will be raised, is it now time that we considered applying it to humans in this particular scenario, and then put forth the best possible scenario to come back either to this group, to say it's time we changed that law, go through the National Research Council or the National Bioethics Advisory Commission and say, ''Look, we have this compelling case. There's no longer safety issues involved. We can reduce this issue now to moral and ethical issues. Should we do it, or should we say no?''
    And so, I don't completely buy that notion that we're going to push it just into private unless we only enact this bill and we don't do anything else. Even then, it's going to be fairly expensive, and I don't know that the patents will come out of it to justify the expense.
    Ms. RIVERS. So your argument is, we should put a prohibition on everybody for embryonic research?
    Mr. BOUMA. I think it should go beyond just federally funded research.
    Ms. RIVERS. Anybody else?
    Mr. WILDES. I think one of the things that is clear in this question—this actually cuts all across American health care, because there is no health care system per se. We are a patchwork already of public and private resources. This goes on all the time in every aspect of health care.
 Page 58       PREV PAGE       TOP OF DOC
    I think there is a danger if you only enact a piece of legislation that prohibits federal funding, and that's all that you do, that you are in fact going to leave it into the private sector. I am convinced in this issue, and any issue that has ethical questions involved with it, that the more there is public discussion, the more there is public debate, the more there is supervision and oversight in a public domain, the better off we all are.
    Ms. RIVERS. I have one comment, and then one last question.
    I just wanted to make the comment again on the issue of expectations of children who are the result of cloning. As people were making comments, it reminded me of situations where none of us generally react to the genes of a child. We react to the phenotype of the child. Who do they look like? Do they look like their father, their uncle, maybe their older brother who died in an untimely way? And we create a set of expectations for children based on how they look right now.
    So I'd be surprised to see that we would have a set of expectations that would be significantly different. I think every set of parents have so many things they want and hope for their children, and try to make real. I'm not so sure this creates a really unique situation.
    But the last question I have is one I asked a couple of hearings ago, and I apparently asked it inappropriately, because I got a couple of really nasty phone calls. I'm going to try again and see if I can.
    Given—if we accept regulation as a given, if we say the government is going to get involved in issues of science, that is a given, and they're going to regulate. Is it better to restrict the questions that can be asked—in other words, we will forbid certain kinds of inquiry and research entirely, because we're offended by the questions that are being asked; or, should we let the questions be asked, and then decide how to regulate the answers once we have them?
 Page 59       PREV PAGE       TOP OF DOC
    Dr. Haney?
    Dr. HANEY. I think that's actually what's happening. If you go to an IRB, they don't ask for what your results are, and whether we're going to fund you retrospectively. They look at the question you're asking.
    If the question you're asking—the chemotherapy you'd like to apply in some odd way to a patient—is an inappropriate question, you don't get to ask it. They won't even approve.
    Ms. RIVERS. How would you characterize this debate around cloning?
    Dr. HANEY. First of all, let me say we've already had in this hearing—he just used the words ''embryonic research,'' and it begins to drift from human cloning. I'd simply like to make sure we understand that we're here talking about human cloning.
    There is a separate area of research that we hope—and all of us from a little different perspective—that that blur does not overshadow the other research that ought to be done. We keep drifting a little bit from that. I want to make sure we always keep that point.
    But it is extremely difficult to focus research if you don't pay for it. I don't care what you say—talk about constitutionality. There's no way you're going to prevent things from being done in the private sector. The Constitution just will not allow that.
    So engagement and control up front, with the dollar control of ''We fund this research; IRBs will clearly not let you ask inappropriate questions and then look for the answers.'' And when you look at cloning, if you came to the IRB and said, ''I would like to clone this human because he's the best basketball player in America ''
    Ms. RIVERS. It would take several committee meetings to determine just who that is, though.
 Page 60       PREV PAGE       TOP OF DOC
    Dr. HANEY. And I would point out we have Jesuits on those committees, participatory.
    So we're very willing to submit this area to the kind of public scrutiny that it deserves, and public debate. Most other countries have indeed chosen to do this. They have done it on a national level, and the societies aren't in conflict, because they have concurred in how the research dollars are spent, based on their participation.
    Ms. RIVERS. Thank you.
    Mrs. MORELLA. Thanks, Ms. Rivers.
    Mr. Ehlers?
    Mr. EHLERS. A host of questions and comments. Congresswoman Rivers always asks stimulating questions. I would tell her that I think anyone who clones Michael Jordan would have very different expectations than you had for your children, and would be very disappointed if they weren't fulfilled.
    The comment that we're drifting—I don't think that we're drifting at all. I think the issue of embryonic research is very much here. In fact, the members of NBAC who testified before us made it clear the only reason they didn't address it is because they felt it had already been addressed. And something that was already addressed they just simply left off the table. Perhaps that could be done in these bills as well, but that issue is certainly going to be before us in the Congress, and I think it's before us in this Committee as well.
    I would like to point out that I have introduced two bills. There's only one before this Committee because of jurisdiction. That's the issue of federal funding. The other bill deals with an absolute prohibition on cloning research, and I would also point out the President's bill does the same.
    I noticed your bill language, which is modeled on the President's bill, prohibits just the expenditure of federal funds. But the President's bill is—well, I can read the prohibition.
 Page 61       PREV PAGE       TOP OF DOC
    ''It shall be unlawful for any person or other legal entity, public or private, to perform or use somatic cell nuclear transfer with the intent of introducing the product to then transfer into a woman's womb, or in any other way creating a human being.'' It's clearly a prohibition.
    Dr. Haney has said that this is something we can't control. I can assure you we can. He also implied we shouldn't, and I think we should. Clearly, if someone decides to make lampshades out of human skins, that's something the Federal Government's going to control; no question about it.
    There are lots of other things that the Federal Government controls. And maybe I totally misunderstood you, but I was surprised at the comment you made at the end there.
    I also just want to respond—there have been some pejorative connotations in this discussion about a poorly-drafted bill rushing to legislation. I always find that amusing. Only opponents to bills use that term. Virtually everyone in the Nation condemns us for moving at such a glacial pace on legislation.
    I can assure you we're not rushing to legislation. By the time these bills, if they succeed, get out of this Committee, out of the Commerce Committee, through the House, through the Senate committee, through the Senate, and pass the President's signature, it will not have been rushed. We've got a long time to go. That's why we're holding these hearings and requesting input.
    The argument that we should just use the moratorium, as we have in the past—I would point out that is clearly not the intent of the founders of this Nation or of the Constitution. That's the action of a President. It's strictly dependent on a President. We have a number of cases where President Bush instituted something. As soon as President Clinton got in office, he changed those policies. These are very controversial actions. Some of them are still undergoing legislative consideration.
 Page 62       PREV PAGE       TOP OF DOC
    But the Constitution clearly envisions the Legislative Branch of the government dealing with those issues—the closest to the people, dealing with the people's desires on that. So I recognize the desire to have just a moratorium, but I think if you're really looking at the separation of powers and the job that each of us is supposed to do, it rightly is in the Legislative Branch to do it.
    I'm just making several comments in response to the comments made by the panel, and I would appreciate your responses that any of you wish to make about any of these issues. Dr. Rigby?
    Ms. TAUNTON-RIGBY. I'd like to make a comment on the embryo research, because that is a critical issue.
    We've had 10-plus years of debate on embryo research, and nothing that was done with Dolly has changed that. NBAC did not deal with it, because they felt that the guidelines and the laws around embryo research were well-thought-out and understood, and people were working within those constraints, and that was taken care of.
    The research that led up to Dolly has been going on over 10 to 15 years also. Dolly was one unique change and different from all the research that had gone on earlier. And that was something that people had thought was not possible—to take a fully differentiated adult cell and put that back in an egg cell, and generate not just an embryo, a fetus, a newborn, but a full-blown animal. That had never been done, and was thought to be impossible.
    But many times, some of those intermediate steps had been done over 10 years in animal research. So NBAC's approach was to deal with what was new, what was different, because it does have different ramifications.
    So I think it's very important that we deal with the issue that Dolly raised, which is cloning human beings from adults, from pre-existing people. We should not be re-debating the embryo issues, because they're in fact broader than what we're talking about today.
 Page 63       PREV PAGE       TOP OF DOC
    Embryo research and the use of fetal tissues are very, very sensitive issues, and they're ones that we have to tiptoe very carefully on, and we have to deal with separately. Because they are separate from this issue.
    So I would encourage you still to keep it separate, to look at the human cloning, the Dolly type of cloning, because that's what we're here to talk about today.
    Mr. EHLERS. Let me ask you a question. Then I'm going to ask the two gentlemen on the end of the table to respond to your statement.
    But what type of research is being done using embryos which could not be done using other techniques vis-a-vis the cloning issue?
    Ms. TAUNTON-RIGBY. There's a lot of information about human reproduction and human diseases involving gene regulation that we can only understand by working with human cells. I point out some of the data that's available on animal experimentation that points out that humans are different.
    One of the reasons a lot of this technology is being done in cows and sheep, because cow and sheep cells will grow from fertilization through to a larger number of cell divisions before differentiation starts to happen. With mice, it happens after two cells. In humans, it's thought to be somewhere around four cells. That's the reason why, in fact, this technology may actually never be applicable to humans.
    But it tells you that differentiation is a different process in each species, and we can't understand everything that we need to understand to solve a lot of medical problems by working only in animals. So at some point, some very careful, well-regulated, well-controlled, well-thought-out experiments have to be done with human cell lines.
    So that is one reason why we have to have guidelines on embryo research, and we need to do it. The same is true of fetal tissue research. There's stringent guidelines on the use of fetal tissue, but again we are beginning to make progress in being able to understand some diseases, and maybe come up with some treatments. So we have to continue certain lines of research, but in a controlled fashion, and bearing in mind all the time the ethical consequences. We have to have public debate of those. It has to be a constant process.
 Page 64       PREV PAGE       TOP OF DOC
    Mr. EHLERS. Dr. Bouma, Dr. Wildes?
    Mr. BOUMA. I think what is being suggested here is there is a need for research in which we take fertilized eggs and blastomeres, allow them to develop some, and then dissect them apart. We have no intention of allowing them to go to implantation, but we can at least learn something about what's going on in the developmental process, and maybe in so doing we can solve some of the problems of infertility or enhance our understanding with respect to what's going on with these processes. And when the processes go awry, when might that be occurring, what might we do about it to rectify them?
    What's disturbing to a great number of people—myself, too—is that this is allowing the initial steps in the development of a genetically new individual to take place, only to be sacrificed for the well-being of others. And however you feel about the moral status of the pre-implantation embryo will seriously affect how you view this particular research.
    Certainly, the embryonic cloning would involve creating embryos, and then taking those nuclei and transferring them into enucleated eggs. So depending on how this legislation is crafted, it could curb what is presently allowed largely only in the private sector and now say it's no longer allowed in the private sector, either. That is, the pre-implantation genetic diagnosis work is being done largely in the private sector right now. It's not permitted through federal funding, and if this legislation says, ''You may do the work with embryos, pre-implantation embryos,'' then it might potentially curb some of that sort of work.
    Mr. WILDES. The distinction, if I can draw it between the two—not just the scientific, but the moral distinction—would be the question between cloning from an adult, or an existing human being, and the embryo research. It gets us back to the fundamental issues that have been so difficult for this Nation since Roe v. Wade about how one understands the moral status of early human life from pre-implantation on.
    I think that's why it is good, especially if one starts to think about legislation, to really discipline what it is we're addressing within the legislation and be clear about that. As Dr. Bouma has pointed out, how you view, for example, pre-implantation diagnosis is going to be extraordinarily directed or colored by your understanding of early human life and your value commitments about it.
 Page 65       PREV PAGE       TOP OF DOC
    Mr. EHLERS. Thank you.
    One last comment, getting back to the rush to legislate. Several countries—Argentina, Australia, Great Britain, Denmark, Germany, and Spain—previously enacted laws banning cloning of human beings well before Dolly came along. I've also given a lot of thought to this issue over the years, and deliberately delayed introducing it until there was a public outcry, because I anticipated there would be a lot of other legislation introduced, and you referred to some that was introduced in various States.
    I felt it best to deal with it, have someone with at least a scientific background of some sort—though not in your field—dealing with it and working with you on that. I just wanted to add that clarification.
    Thank you, Madam Chairwoman.
    Mrs. MORELLA. Thanks, Mr. Ehlers.
    Finally, would you like to do the cleanup, wrapup, Mr. Bartlett?
    Mr. BARTLETT. Thank you very much.
    Wherever you stand on embryo research, is there general consensus on the part of the panel that we have had a debate on that subject, and that it need not be involved—further debate need not be involved in the issue currently before us?
    I see nodding and affirmation by all five of the panelists. Let the record show that all five of the panelists concur, regardless of their position on embryonic research, that we have had a long debate on that. But that debate does not need to now be joined with the subject that is now before us.
    Let me ask about the urgency for legislation. Clearly, we are weighing two things against each other to determine how soon we need legislation, what legislation we need. One is the public perception, and the other is the current order in research.
    Is there a general consensus on the part of the panel that the moratorium has now reasonably assured that this kind of research will not go forward with federal funds? I don't see universal—now I see universal agreement from the panel that the moratorium is working.
 Page 66       PREV PAGE       TOP OF DOC
    And so, your counsel would be—and I do not know what that time frame is—that this dialogue be engaged in to the point that we can enact the best legislation, rather than the need to rush to immediate legislation? Thank you very much; again, all of the panel is showing that they generally concur with this.
    Just a question about preemption. If all that we are talking about is prohibiting the use of federal money for this kind of activity, is there in fact any need for any preemption of state laws, since by definition federal money is controlled by the Congress?
    Ms. TAUNTON-RIGBY. If there was no federal legislation covering federal funds, States can still put some constraints on the federal funds being used in their States. So you'd still have the patchwork. That's why I think it's important that there is legislation to have federal——
    Mr. BARTLETT. So your argument is that if there's going to be legislation, it ought to be federal regulation, rather than permitting each State to enact laws of their choosing?
    Ms. TAUNTON-RIGBY. If we were to have some well-reasoned, well-thought-out—which is, I think, the direction that we're going in—then it's important that we have the debate at a national level, come up with some federal language that's preemptive so there's no need to have 50 versions of this hearing and 50 different outcomes happening in each of the States. Those can cover the federal funding if there is no federal law.
    Mr. BARTLETT. If the legislation deals with federal funding, then almost by definition a federal law would remove the necessity of any state legislation, would it not? So, whether preemptive language was included in the legislation or not, the effect would be preemptive, would it not, since States would then have no need for legislation?
    Ms. TAUNTON-RIGBY. I think the State can regulate the same person. So you don't preempt unless you put preemptive language in there. So the State could then pass a more restrictive law or a different definition, so the researcher would then have to meet two standards and two different sets.
 Page 67       PREV PAGE       TOP OF DOC
    So you need to have the language saying preemptive, so there aren't state laws that are different.
    Mr. BARTLETT. I understand the issue. And if it's the use of federal money, then I think that the Congress has jurisdiction over how federal money is used. If the preemption you're talking about is telling the States that they cannot place further restrictions on how federal money is used, then I don't have a constitutional problem with this.
    If you're telling the States that they can't pass additional legislation, then I think that we have some real constitutional questions about that.
    Thank you again very much for your testimony and for your answers.
    Mrs. MORELLA. I want to thank the panel very much. We have kept you here longer than we expected to, but you can see the caliber of the questioning and the tremendous interest of the Subcommittee.
    Again, I'm very hopeful—I don't think unjustly sanguine—about the fact that we can work out that kind of legislation that I think you all pretty much agree on. I'm hoping that you will work with Dr. Ehlers and with the Subcommittee on it, and get further information to us—any input that you think is appropriate and necessary.
    I thank you all very, very much, and the hearing is now adjourned.
    [Whereupon, at 4:20 p.m., the hearing in the above-entitled matter was adjourned.]
    [The following material was received for the record:]
    Insert offset folios 80-114


 Page 68       PREV PAGE       TOP OF DOC









JULY 22, 1997

[No. XX]

Printed for the use of the Committee on Science


 Page 69       PREV PAGE       TOP OF DOC
F. JAMES SENSENBRENNER, Jr., Wisconsin, Chairman
CURT WELDON, Pennsylvania
KEN CALVERT, California
PHIL ENGLISH, Pennsylvania
TOM A. COBURN, Oklahoma
 Page 70       PREV PAGE       TOP OF DOC

GEORGE E. BROWN, Jr., California RMM*
BART GORDON, Tennessee
ROBERT E. ''BUD'' CRAMER, Jr., Alabama
PAUL MCHALE, Pennsylvania
LYNN N. RIVERS, Michigan
ZOE LOFGREN, California
MICHAEL F. DOYLE, Pennsylvania
BILL LUTHER, Minnesota
WALTER H. CAPPS, California
BOB ETHERIDGE, North Carolina

TODD R. SCHULTZ, Chief of Staff
BARRY C. BERINGER, Chief Counsel
 Page 71       PREV PAGE       TOP OF DOC
PATRICIA S. SCHWARTZ, Chief Clerk/Administrator
VIVIAN A. TESSIERI, Legislative Clerk
ROBERT E. PALMER, Democratic Staff Director

Subcommittee on Technology
CONSTANCE A. MORELLA, Maryland, Chairwoman
CURT WELDON, Pennsylvania

BART GORDON, Tennessee
LYNN N. RIVERS, Michigan
PAUL MCHALE, Pennsylvania
MICHAEL F. DOYLE, Pennsylvania

 Page 72       PREV PAGE       TOP OF DOC
*Ranking Minority Member
**Vice Chairman


July 22, 1997:
Hessel Bouma III, Professor of Biology, Calvin College Biology Department, Grand Rapids, MI
Kevin Wildes, Associate Director, Kennedy Institute of Ethics, Georgetown University, Washington, DC
Dr. Arthur F. Haney, President-Elect, American Society for Reproductive Medicine and Director, Department of Endocrinology and Infertility, Duke University Medical Center, Durham, NC
Alison Taunton-Rigby, President and Chief Executive Officer, Aquila Biopharmaceuticals, Worcester, MA
Lester M. Crawford, Vice Chairman, National Association for Biomedical Research and Director, Center for Food and Nutrition Policy, Georgetown University, Washington, DC
    Statement of the American Society of Animal Science
    Statement of the General Board of Church and Society of the United Methodist Church
    ''A Protestant Perspective on Cloning''
    ''The Brave New World of Cloning: A Christian Worldview Perspective''
    Amendment in the Nature of a Substitute to H.R. 922, offered by Hon. Vernon Ehlers
 Page 73       PREV PAGE       TOP OF DOC