Segment 2 Of 2 Previous Hearing Segment(1)
SPEAKERS CONTENTS INSERTS
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TUESDAY, JUNE 19, 2001
House of Representatives,
Subcommittee on Crime,
Committee on the Judiciary,
The Subcommittee met, pursuant to notice, at 4:05 p.m., in Room 2141, Rayburn House Office Building, Hon. Lamar Smith [Chairman of the Subcommittee] presiding.
Mr. SMITH. The Subcommittee on Crime will come to order. We welcome our witnesses.
I have an opening statement, then I will recognize other individuals who are here, who might have opening statements, and then we will proceed to hear from our expert witnesses.
Today the Subcommittee on Crime holds the second of two hearings on the issue of human cloning. At our last hearing, the Subcommittee focused on the ethical issues and possible consequences of cloning human beings.
Now we will examine the legal issues relating to the Federal regulation of human cloning and hear testimony regarding two bills on the issue, H.R. 1644 and H.R. 2172.
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Prior testimony revealed that there are a growing number of groups who claim they can and will clone a human being. Currently, no clear regulations exist in the United States that would prevent a private group from attempting to create a human clone. In this sense, the United States lags behind most other industrialized nations.
Even though the Federal Food and Drug Administration has asserted that it has the authority to regulate this activity, legal scholars have expressed doubt as to whether this claimed authority would stand a legal challenge. Furthermore, the consequences for any scientist who ignores the FDA's claimed authority are unclear.
Legal challenges to any Federal regulation of human cloning will be swift. Opponents will argue against any ban on human cloning because it allegedly interferes with the desire for scientific inquiry. Yet an overwhelming majority of Americans oppose cloning.
Scientific advancement can enrich our lives, but not when it erodes our most fundamental principles. While there is room to roam, it is not an open range.
Although Congress may not prohibit research in an attempt to prevent the development of new knowledge, it may restrict or prohibit the means used by researchers that threaten interest in which the citizens of this country have a legitimate concern.
The two bills before us today would prohibit the cloning of human beings. However, the scope of that prohibition is treated in very different and important ways.
Page 96 PREV PAGE TOP OF DOC Segment 2 Of 2 H.R. 2172, introduced by Congressman Greenwood of Pennsylvania, requires courts to determine a scientist's intent. If the scientist clones a human to initiate a pregnancy, he is in the wrong. If he clones without that intent, he is right.
H.R. 1644, introduced by Congressman Weldon of Florida, prohibits the use of human cloning technology to produce a living human organism at any stage of development. The Weldon bill would make it a criminal act to clone a human embryo for any reason, scientific or reproductive.
Neither of these bills places any restrictions on the use of cloning technology to clone molecules, DNA, cells, tissues, organs, plants, or animals. They would not interfere with the use of in vitro fertilization, fertility-enhancing drugs, or other medical procedures that help women to become or remain pregnant.
Today we will hear from a panel of four witnesses who have extensive backgrounds in the field of law and bioethics. I would like to thank the witnesses for appearing before the Subcommittee on this important issue.
The Chair now recognizes the gentleman from California, Mr. Schiff, for his opening statement.
Mr. SCHIFF. Thank you, Mr. Chairman.
The image of Dolly, a sheep cloned in Scotland in 1997, is a vivid one in all of our recollections. All our impressions at the time, of what that scientific achievement meant and the important ethical issues it raised, have not been far from our thoughts ever since.
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Although Dolly's cloning was a scientific success, the process of cloning remains a highly contentious issue. Most people have a fairly narrow notion of what the term cloning means, particularly in regard to humans. In fact, it encompasses a number of scientific processes with widely diverse meanings, whether applied to animals or humans.
Today we'll hear about two different types of cloning. One is human reproductive cloning designed to create a human child. The other is the cloning of human cell for the purpose of medical achievement.
In 1997, the Clinton Administration asked the National Bioethics Advisory Commission to study the ethical and legal implications of cloning. A ban on the use of any Federal funding for cloning was quickly put into place. Since then, researchers, ethicists, scientists, religious leaders, and politicians have debated the issue.
With the possibilities offered by biomedical research, we have an incredible opportunity to potentially clone our own cells to replace diseased or defective cells with no chance for rejection, since it is already a cell familiar to our body.
This research is playing a crucial role in the advancement of modern science and may be the key to transforming the way diseases are treated in the United States and around the world.
Some cells can be used to generate specialized cells that are destroyed or damaged in various diseases and disabilities, which could in turn lead to vastly improved treatments or cures for Alzheimer's disease, AIDS, Parkinson's, cancer, birth defects, and countless other conditions.
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Last year, the National Institutes of Health ensured that this scientific research would be conducted in accordance with the highest scientific and ethical standards. Since then, the Bush Administration has put a hold on Federal funding for stem cell research while it reviews the guidelines put forward by NIH.
In fact, the very first meeting scheduled for April of this year, where an NIH committee was to review the first applications from scientists seeking Federal funds for human embryo cell research, was canceled after officials from the Department of Health and Human Services requested they do so.
For the sake of everyone out there who has suffered from the dreaded diseases that we now have a chance of attacking with new methods, including my own mother-in-law who passed away with Alzheimer's disease earlier this year, I'm hopeful that we can bridge our differences on the issue of research and advance the cause and course of medical science.
Today we are faced with the issue of how to best prevent human cloning with a bill drafted broadly enough to ban human cloning itself but narrow enough so that it doesn't prevent vital lifesaving and highly desirable biomedical research.
The two bills before this Committee take a somewhat different approach. One bill, H.R. 1644, introduced by Representatives Weldon and Stupak, makes it a crime to participate in any type of human cloning for any purpose. The other bill, H.R. 2172, introduced by Representative Greenwood, is focused on reproductive cloning but is more narrowly crafted and perhaps more protective of scientific study.
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Both bills include an exception for the use of cloning techniques to produce copies of DNA, tissues, organs, plants, or animals other than humans. But the use of cloning to produce embryos is still forbidden.
We already have certain restrictions on the use of Federal funds for human cloning. And the FDA has declared that cloning experiments cannot proceed without its approval. These restrictions prevent human cloning while allowing beneficial scientific research to proceed, although questions have been raised as to whether the FDA has the necessary power to deter improper cloning.
There was a broad consensus that we are not ready for the cloning of a human being. Perhaps we never will be. Perhaps we never should be.
How we prohibit cloning and protect vital research is the subject of our inquiry. I look forward to the testimony of the witnesses and the insight they provide to us on this complex issue.
Thank you, Mr. Chairman.
Mr. SMITH. Thank you, Mr. Schiff.
And let me mention that Mr. Schiff is an able stand-in for Bobby Scott, the Ranking Member, who had a conflict this afternoon and could not be with us.
Page 100 PREV PAGE TOP OF DOC Segment 2 Of 2 Let me introduce all the witnesses and then we'll begin.
Alex Capron, Professor of Law and Medicine, University of Southern California School of Law, Los Angeles, California; Jean Bethke Elshtain, Professor of Social and Political Ethics, the University of Chicago, Chicago, Illinois; Gerard Bradley, Professor of Law, Notre Dame Law School, Notre Dame, Indiana; and Thomas Okarma, President and CEO, Geron Corporation.
Thank you all again for being here.
And, Professor Capron, we will begin with you.
STATEMENT OF ALEX CAPRON, PROFESSOR OF LAW AND MEDICINE, UNIVERSITY OF SOUTHERN CALIFORNIA SCHOOL OF LAW, LOS ANGELES, CA
Mr. CAPRON. Good afternoon.
Thank you, Mr. Chairman, for this opportunity to testify before your Subcommittee. I will attempt to summarize the main points of my written statement that has been submitted for the hearing record.
Though I must be brief, I want to make clear that my remarks are in two parts, as I have been invited to speak both as a member of NBAC, the National Bioethics Advisory Commission, and as an expert in legal issues and bioethics. I will first present relevant NBAC conclusions and then state my personal views.
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NBAC began its work in October 1996. Not long thereafter, President Clinton, in response to the news reports that scientists in Scotland had succeeded in cloning an adult mammal for the first time, asked the commission to examine the ''serious ethical issues'' raised by ''possible uses of this technology to clone human beings.''
NBAC immediately undertook and intensive and open examination of the topic, hearing from experts in law, science, medicine, ethics, religion, as well as members of the general public.
A little more than 3 months later, on June 9, 1997, we submitted our report, ''Cloning Human Beings,'' to the President, and a copy of that report has been submitted for the record as well.
In the light of the ''unacceptable risks to the fetus and/or potential child,'' we wrote, and of the many other serious ethical concerns,'' which ''require much more widespread and careful public deliberation,'' the commission concluded that ''at this time it is morally unacceptable for anyone in the public or private sector, whether in a research or clinical setting, to attempt to create a child using somatic cell nuclear transfer.''
To this end, we recommended, among other things, that a Federal moratorium be imposed on human reproductive cloning for 3 to 5 years, at the end of which an appropriate oversight body would evaluate the current state of the science and of the ethical and social debate.
Page 102 PREV PAGE TOP OF DOC Segment 2 Of 2 We made no recommendations regarding research cloning, the creation of embryos through somatic cell nuclear transfer that would not be placed in a uterus to attempt to create a pregnancy.
Though sometimes labeled therapeutic cloning because of the hope that someday such cells might be used to generate cells, tissues, or even whole organs for transplantation, a lot remains to be learned before the label therapeutic would even possibly be appropriate or before, in the commission's words, ''it would be scientifically sound and therefore potentially morally acceptable to go forward with this approach.''
The announcement in November 1998 that researchers at the University of Wisconsin and Johns Hopkins University had for the first time succeeded in creating human pluripotent stem cells from IVF embryo and aborted fetuses resulted in NBAC being asked to undertake another study.
The following September we recommended that changes be made in the statutes and regulations to allow Federal funding of research involving the derivation and use of human stem cells from aborted fetuses and from embryos remaining after infertility treatments, subject to appropriate ethical standards and procedures that include public oversight and review.
We also said that research involving stem cells from human embryos made using somatic cell nuclear transfer should not be eligible for Federal funding at this time. We did not address whether this research should be allowed in the private sector.
I would now like to turn to the legislation before you, H.R. 1644, the Human Cloning Prohibition Act of 2001. NBAC did not directly address the question that is before this Committee, namely whether effective control of reproductive cloning requires controlling the creation of cloned human embryos. Therefore, what I have to say now reflects my personal views rather than those of the commission.
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H.R. 1644 would ban both reproductive and research cloning. The first is not controversial. Indeed, a ban on any attempt at cloning a baby is favored by the majority of the American people for reasons that you have already heard from witnesses at the prior hearing.
The ban could be a moratorium for a term of years, as NBAC recommended, or it could be of unlimited term, which is the view that I have come to favor as I've become more concerned with both the physical and psychological risk to any child produced through cloning, and more convinced that the reasons offered for its use are slight compared with its potential harm to society, the family, and, indeed, to the prospects of a decent future for humankind.
Why, then, hasn't some form of prohibition been enacted? Largely, as far as I can tell, due to partisan politics and disagreements over other topics, such as the permissibility of embryonic stem cell research. I regard this as tragic, and I am here to plead with Members of this Committee and with your colleagues in both houses of Congress to seek a way of halting reproductive cloning effectively and without further delay.
As I think you can see, to be effective, a ban needs to encompass the creation of cloned embryos in the lab, if you're going to avoid aiding reproductive cloning indirectly or perhaps directly.
As can be seen by looking at H.R. 2172, if cloned embryos exist in labs, it will be very hard to stop people who want to use them to create a pregnancy. The highly entrepreneurial fertility field is characterized by a lack of effective professional or governmental oversight, and a history of ethical scandals, including poor control over embryos.
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Thus, simply from a strategic viewpoint, if you want to halt reproductive cloning, you need, at this point, to control research cloning as well.
The second strategic argument concerns getting a bill adopted. It hasn't happened in the past 4 years. People are going to have to find common ground and to agree on a compromise result, albeit for different reasons.
One way of reaching a compromise would be to apply the method that NBAC recommended for reproductive cloning and change the absolute ban on research cloning in H.R. 1644 to a moratorium.
You need to indicate to the research community not only that the ban on the creation of embryos through somatic cell nuclear transfer is carefully limited to that one type of cloning, but also that it is not necessarily permanent but will be reviewed in, say, 5 years.
Meanwhile, other lines of research can go forward on the cloning of animals, on adult stem cells, on perfecting the means to differentiate stem cells into specific cell tissue and even organs that function normally if transplanted, and on the antigenicity of such cells, tissues, and organs, creating from stem cells that are not clonally matched with a recipient.
If researchers arrive at the point where the use of cloned embryos offers a means of achieving a lifesaving therapy that is otherwise unobtainable, they can then ask the public to weigh those no longer merely hypothetical benefits against the risks of leakage to reproductive cloning and against the well-being of the embryos that would be destroyed.
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Since they feel so confident of the eventual therapeutic outcome, this is a burden that should not worry the biotechnologists.
Therefore, I urge you to change the ban to a time-limited moratorium as a compromise that should satisfy both sides and would more effectively stop reproductive cloning without preventing scientists pursuing many other lines of research that are needed before the hypothesized therapeutic benefits of research cloning can be realized.
When our descendantsand I do hope they are truly our descendants and not manufactured replicantslook back to this time, let them find that we were equal to this unprecedented challenge.
The United States should take a lead in protecting our human future by locking the barn door on reproductive cloning and by persuading other nations that, at this time, a ban on cloning of human embryos represents the best way to ensure that the cows stay in the barn.
[The prepared statement of Mr. Capron follows:]
PREPARED STATEMENT OF ALEXANDER MORGAN CAPRON
As Commissioner, National Bioethics Advisory Commission
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Thank you, Mr. Chairman. I am Alexander Capron, and I have been invited to testify before the Subcommittee in two capacities today: as a member of the National Bioethics Advisory Commission (NBAC) and as an expert on legal issues in bioethics. In this statement, I summarize relevant conclusion of the Commission, and in a separate statement I present my personal views.
NBAC was chartered by President Clinton in 1995 and began work on October 4, 1996. It studies ethical issues arising from biomedical and behavioral research and makes recommendations to the President, the National Science and Technology Council, and others. My fellow commissioners include physicians, theologians, ethicists, scientists, and lawyers, psychologists, and members of the general public.
On February 24, 1997, the day that the American news media reported that scientists in Scotland had succeeded in cloning an adult mammal for the first time, President Clinton asked NBAC to examine the ''serious ethical questions'' raised by''possible use of this technology to clone human beings.'' NBAC immediately undertook an intensive and open examination of the topic, hearing from experts in law, science, medicine, ethics, religion as well as from members of the general public. A little more than three months later, we submitted our report, Cloning Human Beings, to the President.
NBAC focused on a very specific aspect of cloning, namely where genetic material would be transferred from the nucleus of a somatic cell of another human being, living or dead, to an enucleated human egg with the intention of creating a child. We did not revisit issues raised by human cloning by embryo-splitting in fertility clinics: only cloning through the new somatic cell nuclear transfer (SCNT) technique. We examined only ''reproductive cloning,'' not ''research cloning,'' the creation of embryos which would not be implanted in a uterus.
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The Commission discovered that the potential ability to clone human beings through SCNT raises a host of complex scientific, religious, legal, and ethical issuessome new and some old. Especially noteworthy were the medical risks to any child conceived in this manner, as well as the diversity of views that we heard among religious scholars, indeed even among those within the same religious tradition.
The Commission concluded that no onewhether federally or privately supportedshould be permitted to create babies through cloning at this time. To this end, we recommended that a moratorium be imposed on such research. A moratorium gives society a safeguard not only against the extreme risks to any child created in this fashion but also against the possible harms that might accompany crossing the line to controlled, asexual ''reproduction.'' A moratorium also provides a period of time both for further knowledge to be accumulated about mammalian cloning and for serious and sustained reflection about the sort of world that human cloning could create. Then, say three to five years hence, Congress and the President would need to decide whether the results of the scientific research and of the debate on the risks and potential benefits of human cloning had provided sufficiently strong reasons to lift the prohibition and permit human cloning under any circumstances.
Because our Cloning report was prepared in a relatively short period of time, and when the technology was still in its infancy, we made no attempt to write the final word but instead provided a starting point for what we hoped would be the ''profound and sustained reflection'' our Nation needs on the subject of human cloning.
While the commission has not deliberated any further on this topic since submitting the Cloning report to President Clinton in June 1997, our main conclusions still stand. Indeed, in a letter to President Bush on March 16, 2001, NBAC Chair, Harold T. Shapiro, stated:
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While we did not resolve all of those [ethical] issues, we unanimously concluded that given the current state of the science, any attempt to create a human being through somatic cell nuclear transfer would be terribly premature and unacceptably dangerous. Besides being morally unacceptable on safety grounds, the creation of human clones would involve risks to the childrenand more broadly to societythat are serious enough to merit further reflection and deliberation before this line of research goes forward.
Issues relating to cloning emerged again with the announcement in November 1998 that researchers at the University of Wisconsin and Johns Hopkins University had for the first time succeeded in creating human pluripotent stem cell lines from embryos remaining after infertility treatments and aborted fetuses. President Clinton requested that NBAC also review the issues associated with that research. Again, the commission heard testimony from a wide range of experts and commentators as well as the public. After many months of public deliberation we concluded in our report Ethical Issues in Human Stem Cell Research that changes should be made in statutes and regulations to allow federal funding of research involving the derivation and use of human stem cells from aborted fetuses and from embryos that would otherwise be discarded, subject to appropriate ethical standards and procedures that include public oversight and review.
In that report, the commission recommended that research involving the derivation or use of stem cells from human embryos made using SCNT should not be eligible for federal funding at this time. However, NBAC noted that there was significant reason to believe that use of stem cells from such embryos may have therapeutic potential, due to the utility of matched tissue for autologous cell replacement therapy, and stated that scientific progress and medical utility in this area of research should be monitored closely. NBAC did not address whether or not this research should occur in the private sector.
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At the time it considered the question of cloning, NBAC had several courses of action under consideration. One would have been no moratorium on any activities. The second would have been a moratorium on both reproductive as well as research cloning. The third, which is the one that the commission actually chose, was a temporary moratorium on reproductive cloning, but no moratorium on research cloning. In so doing, NBAC recognized that while important moral considerations are at stake, with respect to research and reproductive cloning, the nature of those moral considerations are different in kind. With respect to research cloning, the issues are those associated, in general, with the embryo research debate. With respect to reproductive cloning, however, the issues pertain to the safety of the fetus and mother and the potential impact of reproductive cloning on the resultant children and our institutions of parenting and child bearing. It was because of the difference between these types of considerations that a moratorium was considered appropriate in one case (reproductive cloning) but not the other (research cloning). At the time it considered stem cell research, the commission once again considered the question of research cloning. Here it concluded that the case had not yet been made for a need for federal funding for this activity. It did not, however, propose a moratorium on privately funded activity in this area.
Those are the recommendations of NBAC. While I suspect that the commissioners hold a range of views on the consequences to society of the development and use of SCNT to create children, all of uslike the overwhelming majority of Americansagree that those consequences would be profound; and further, that the risks have not yet been adequately explored, much less carefully balanced against competing interests, whatever they might be.
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I will now state my own understanding of NBAC's reports, but my views are my own, and I am aware that they do not reflect those of all my fellow commissioners.
One of the bills before you, H.R. 1644 ''The Human Cloning Prohibition Act of 2001,'' would permanently prohibit the use of SCNT to create human embryos for any purpose, including reproductive cloning and the creation of embryos as a source of embryonic stem cells. NBAC did not directly address one of the questions that is before this Committee, namely, whether the control of reproductive cloning requires controlling the creation of embryos by SCNT for research purposes. It is my opinion, however, that our Cloning reportwhen read in light of subsequent developments in that field and of the Stem Cell reportsupports completely halting all attempts to create human embryos through SCNT at this time.
Obviously, the most contentious issue in H.R. 1644 is the prohibition on the use of SCNT to create cloned embryos from which stem cells of a predetermined genetic background could be derived. Though often labeled ''therapeutic cloning'' because of the hope that someday such cells could then be used to generate cells, tissues, or even whole organs for transplantation, I believe the term ''research cloning'' is more accurate. As NBAC recognized in Cloning Human Beings, an essential step before the label ''therapeutic' would even possibly be appropriate would be for scientists to understand how to direct cellular differentiation along a specific path to produce the desired material for transplantation: ''Given current uncertainties about the feasibility of this, however, much research would be needed in animal systems before it would be scientifically sound, and therefore potentially morally acceptable, to go forward with this approach'' (p. 30).
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We reinforced and expanded on this conclusion in the Stem Cell report. Although limited to the question of federal funding, I believe that report has wider implications, because we favored such funding not only to help ensure that the federal government would be in a position to set ethical standards to guide all researchers in this field but also because we felt that serious public detriment would be arise from leaving the development of science in this field entirely to private, and often commercial, researchers while excluding scientists at federal institutes (such as the NIH) and those conducting studies with federal support.
Had a stronger justification been shown for using SCNT to create embryos for stem cell research, I do not believe that we would have opposed federal funding. The need for cloning human embryos was simply not established, given the rudimentary state of the science on such matters as mammalian cloning in general or controlling the differentiation and development of cells and organs from pluripotent stems cells. In addition, NBAC recognized the availability of human embryos remaining after fertility treatments to meet the needs of researchers. In my opinion, that picture has not improved in the subsequent 21 months. If anything, the arguments for emphasizing basic research with nonhuman stem cells is even greater in light, for example, of the sad results involving unregulated cellular activity in the brains of some Parkinson's patients who received fetal tissue transplants in experiments in New York and Colorado. Furthermore, the problems with development of the few cloned animals that have survived to birth provide a warning signal that we cannot simply assume that stem cells generated from cloned human embryos would themselves function normally.
Not only are we years away from having a good basis for using cloned embryos for ''therapeutic'' research on human patientsubjects, but other avenues are being pursued that might mean that cloned embryos will never be needed to achieve good results in transplantation. First, scientists are investigating whether embryonic stem cells are, as some believe, less likely to stimulate rejection following transplantation. If that proves to be the case, transplantation could be performed using tissues and organs derived from existing cell lines without having to produce cells that are clonally identical to transplant patients. Second, promising laboratory work on adult stem cells harvested from a number of tissues offers the prospect of achieving autologous cellular therapy and transplantation without the need for cloned embryonic stem cells.
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In light of the ethical and moral concerns raised by the use of human embryos for research, NBAC concluded that ''it would be far more desirable to explore the direct use of human cells of adult origin to produce specialized cells or tissues for transplantation into patients,'' though we noted that the possible use of adult stem cells ''will be greatly aided by an understanding of how stem cells are established during embryogenesis'' (Cloning Human Beings, p. 31). Thus, while such research with adult cells does not obviate the need for research with embryonic stem cells, all these lines of researchincluding research in animalshave much further to go before questions arise that can only be answered through the creation of human embryonic stem cells cloned through SCNT.
I have already mentioned the NBAC Cloning report recommended a prohibition on human reproductive cloning, but only for a time period of three to five years, after which time Congress and the President should revisit the issue and decide whether the prohibition would stay in place. H.R. 1644 includes a permanent prohibition on all SCNT. For myself, I would be comfortable with the bill as written, namely that the ban on reproductive cloning (but not research cloning) not be time-limited. Many reasons have been offered by those who favor cloning, from the wish to create a copy of oneself or of another esteemed person to the desire to replicate a deceased relative (particularly a child) to simply having an alternative means of reproduction, whether as a means of overcoming infertility or otherwise. None of these reasons seem compelling to me. Beyond the risk of physical harm to child and perhaps to mother, cloning poses potential psychological and social harm to the children produced by this technology. More fundamentally, the use of cloning to produce children would not merely be the ultimate form of eugenics but an alteration of the basic relationship between generations. In the context of other means of genetic manipulationindeed, the very means that Dolly's makers had in mind in developing SCNT in mammals, namely the creation of large numbers of animals whose genotype had been modified to produce a desired phenotypeallowing reproductive cloning would be the decisive step toward the Brave New World. Since I do not think that such a state of affairs would advance the ''more perfect Union'' enshrined as the aspiration of the American people for more than 200 years, I would have no problem with going further than NBAC went, enacting the prohibition now and leaving to those who would so radically alter the manner in which human beings are created the burden of showing that the benefits clearly outweigh the risks.
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It does seem to me, however, that the idea of a moratoriumthat is, a time-limited bancan be usefully applied to the second activity addressed by H.R. 1644, namely the creation of cloned embryos for research purposes. NBAC did not recommend the use of federal funds to support creation of cloned embryos for research at this time. Although NBAC did not recommend a prohibition in the private sector, I have already explained why I think our recommendations can (though need not) be read more broadly to suggest that this area of research should not be pursued by anyone at this time. Thus, it seems fair to me to read Recommendation 4 in our Stem Cell report as consistent with prohibiting efforts to use SCNT to create human embryos for research purposes at this time. I personally agree with the premise of H.R. 1644 that the best (probably the only) way to stop what we all think should be stoppednamely reproductive cloningis to impose a moratorium on research cloning as well. Producing normal human embryos through cloning is probably going to be a challenge, but once such embryos are on hand (available in laboratories and perhaps even as items of commerce) I believe it will prove impossible to prevent efforts to implant them and achieve a pregnancy behind the privacy veil of the physician-patient relationship. The slope here is slippery not just because the step may be taken surreptitiously but because the slide downward will be accelerated by contradictory ethical imperatives. On the one hand, once the cloned embryos have been created, some who oppose reproductive cloning will feel so strongly that the embryos have a right to life that they will insist that the embryos be used to attempt to achieve a pregnancy. On the other hand, once a pregnancy has been established defenders of women's right to control their own reproductionincluding those who are appalled by reproductive cloningwould be as loathe as any anti-abortionist to tell a woman carrying a cloned fetus that she must abort it.
Thus, any serious effort to stop asexual reproduction needs in my opinion to encompass all efforts to create cloned embryos. I believe that placing research cloning off-limits at this time is fully consistent with NBAC's recommendation that such research not go forward now with federal funding because much more work needs to be done in the basic science as well as with adult and noncloned embryonic stem cells before we can possibly know whether the cloning of embryos offers the only means of achieving a potentially life-saving therapy for certain patients.
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A moratorium may not initially appeal to anyone who believes that it is always wrong to create, much less to destroy, a human embryo for research or therapy unconnected with that embryo's own well-being. Yet to these people, I would say that a moratorium achieves the very end that they seek, which is to forbid the creation of cloned embryos. Conversely, for those who do not take that view, a moratorium carries the promise that the issue of research with cloned embryos will be revisited. Just as NBAC favored a moratorium on reproductive cloning so that the issue could be reconsidered, so too Section 4 of H.R. 1644 says that the National Bioethics Advisory Commission or a successor group will study and report back within five years on ''the need (if any) for human cloning to produce medical advances'' as well as the possible impact of permitting research cloning ''upon efforts to prevent human cloning for reproductive purposes.'' Again, I want to stress that the commissioners did not directly face or decide this particular question, but they did agree with the objective of forestalling the cloning of human babies and that grounds for cloning human embryos at this time are not so strong that federally funded scientists need to conduct such research.
A moratorium was accepted by biomedical researchers 27 years ago, at the dawn of the era of genetic engineering, when leading scientists recognized the unpredictable risks associated with some of the experiments and persuaded the community to halt them until the risks could be better assessed and appropriate preventive measures adopted. Last year, on the 25th anniversary of the famous Asilomar meeting that was held to decide whether and how the moratorium should be lifted, I chaired a symposium back at Asilomar in which 50 scientists, social scientists, ethicists, lawyers, government officials, and journalists examined that earlier moratorium and its continuing relevance today. In some ways, the decision to halt work was more difficult a quarter of a century ago because some of what was stopped was ''the next logical step'' in research and was being actively pursued by the leading scientists, which is not true of cloning human embryos today. Yet in other ways, the gene splicing moratorium was easier to accomplish because the risks to be avoided were immediate, physical harms, from injuries to laboratory personnel to potential epidemics of novel pathogens, whereas the ethical and social issues that really underlay the public's concern (and that are the category of risks that arise from human cloning) were not debated at Asilomar. Moreover, as we concluded at the symposium in February 2000, the commercialization of biotechnology has changed the pressures to pursue research as well as the freedom of scientists and their credibility in calling for a halt to research. Thus, while a moratoriumputting some research out of bounds while its risks can be assessed and possible safeguards can be developedis something that biomedical researchers have accepted in the past, the impetus for a moratorium on human embryo cloning probably now must come from the government.
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Researchers must be assured that the moratorium will not prevent other lines of research, either on stem cells not derived from cloned embryos or the cloning of molecules, cells, or the like that does not involve embryos. H.R. 1644 seems to me to accomplish this objective. That leaves the question of whether the moratorium should be framed as a sunset provision that lets the prohibition lapse if not renewed or as ban that remains in place after the mandatory review unless reversed by a majority. Reasonable people may differ on this point, but given both the importance of the subject and the confidence with which biotechnologists predict that the creation of cells from cloned embryos will provide benefits not otherwise available, I conclude that the burden of proof should be left with the proponents of the research when the ban is reconsidered. If they have arrived at the point where the use of cloned embryos offers a means of achieving a life-saving therapy that has been found to be otherwise unobtainable, then I believe they will persuade a majority of people that such steps should be allowed under the most stringent of ethical and practical safeguards.
Agreeing on this course will require each side to compromise. It would seem to meif I may be so bold, and speaking as a citizen and a person concerned with the ethical and policy implications of science and medicine rather than as a member of NBACthat this is one time that people on both sides of the aisle should do all they can to avoid allowing their disagreements on other matters, such as abortion and stem cell research, to stand in the way of a compromise that achieves the central aim that is overwhelmingly supportedand rightly soby the American people, and indeed, by most people around the world.
I hope that these hearings can help promote a genuine dialogue among people holding a range of views on the subject and that a compromise, perhaps along the lines I have urged here, can be forged. In recommending a moratorium on reproductive cloning, NBAC hoped that during the period of three to five years before the issue was reconsidered in Congress, our Nation would engage in ''profound and sustained reflection'' on the issues. Regrettably, four years to the month after we submitted our report, this sort of serious, broadly based public discussion has yet to occur. Partisan disputes have prevented Congress from acting even though it appears that there is overwhelming agreement here that reproductive cloning should not be allowed at this time, And while a good deal of academic debate has occurred, as time has passed the press seems to have found the topic too weighty for continued public scrutiny. Hence, the plans announced by various groups in recent months to develop reproductive cloning are today more often the objects of comedians' humor than commentators' analysis. Indeed, from the tone of the inquiries I have had lately from reporters and from some (though certainly not all) of the media coverage, I sense that the simple familiarity of the topic has served to trivialize it. The initial reaction of many people to the technology and to the prospect of its being applied to human beingsdisbelief and repugnancehas been replaced by disinterest. As one reporter said to me recently, ''Doesn't cloning seem more acceptable now? After all, despite the original objections, nothing bad has happened, has it?'' Well, of course not, because as far as we know, no one (thankfully) has yet tried to clone a human baby. Yet the risk of that happening is great if the serious problems with such a step are not brought before the public and if legislation is not adopted to make clear that no one may take such a step at this time.
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In conclusion, I want to return to Chairman Shapiro's March 16 letter to President Bush, in which he stressed how seriously the present, announced efforts to engage in human cloning ought to be taken. He also stated that adopting a moratorium would bring the United States ''into line with the position adopted by the Council of Europe'' and would ''encourage other nations to do likewise.'' As recommended by the G8 nations at the Denver Summit, and as emphasized in a number of the bills pending before Congress (including H.R. 1644), international cooperation is going to be essential for success. Humankind stands now at an historic juncture. When our descendantsand I do hope they are truly our descendants, not our manufactured replicantslook back to this time, let them find that we were equal to what I think may fairly be labeled an unprecedented challenge. In my view, the United States should take the lead in protecting our human future by locking the barn door now on reproductive cloning and by persuading other nations that at this time a ban on the cloning of human embryos represents the best way to ensure that the cows stay in the barn.
Thank you for the opportunity to present my views on this subject, and I am happy to answer any questions that you may have.
Mr. SMITH. Thank you, Professor Capron.
STATEMENT OF JEAN BETHKE ELSHTAIN, PROFESSOR OF SOCIAL AND POLITICAL ETHICS, THE UNIVERSITY OF CHICAGO, CHICAGO, IL
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Ms. ELSHTAIN. Thank you, Mr. Chairman. Thank you for the opportunity to offer reflections on the political, ethical, and legislative issues presented by the prospect of human cloning.
I teach social and political ethics at the University of Chicago, where I am a member of the Divinity School and Department of Political Science.
My work for nearly 30 years has been devoted to examining the ethical implications of political and social policies and proposals. I consider myself a realist, indeed, a hard-headed realist.
As such, it seems to me that the path down which we are headed, unless we intervene to stop human cloning, is one that will deliver harm in abundance. And that harm can be stated clearly and decisively now, whereas any potential benefit is highly speculative and likely to be achievable through less drastic and damaging methods in any case.
The harms, in other words, are known, not a matter of speculation, whereas the benefits are a matter of conjecture, in some cases, rather farfetched conjecturethis according to the bulk of current scientific opinion.
Now, one of the basic rules of medicine is also a basic rule of politics: First, do no harm.
We are on the pathway to harm. That is why I support H.R. 1644.
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Last August, I was in Berlin, Germany, for an international conference. On that occasion, the Lutheran bishop of Berlin presented a talk in which he expressed alarm at the direction much of the genetics ideology of the present is tending. That ideology identifies the true essence of what is human with a particular genotype.
This ushers into a kind of genetic fundamentalism that reduces our humanity to clusters of traits we phenotypically exhibit or fail toeverything from a desirable height, hair and eye color, skin color, I.Q., physical attractiveness, and so on. And I don't think I need to remind anyone of why they are particularly sensitive to this issue in Germany.
The hope of genetic fundamentalists is that we can increasingly control for that which is deemed desirable and eliminate that which is not.
The aim in all this is not to prevent devastating illnesses but precisely to reflect and to reinforce certain societal prejudices in and through genetic selection. There is a word for this so-called genetic enhancement, and that word is ''eugenics.''
Human cloning belongs to this eugenics project. All the ethical, political, scientific, and juridical arguments against eugenics apply to the prospect of human cloning.
Hans Jonas, the distinguished philosopher and scientist, has already written that cloning is, and I quote, ''both in method the most despotic and in aim the most slavish form of genetic manipulation; its objective is not an arbitrary modification of the hereditary material but precisely its equally arbitrary fixation in contrast to the dominant strategy of nature.'' That's the end of the quote.
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Public policy reflects our understanding of who we are as a people. It indicates where we are going and our appreciation of where we have been. I see this country and our people as strong, determined, energetic, creative, concerned, and realistic, rather than careless and chaotic and sentimentalist.
Banning ill-considered, harmful ventures in human cloning will show us at our best. It will demonstrate that the untrammeled profit motive behind runaway and recklessby contrast to responsible and controlleddevelopments in the area of genetics will not be given full sway no matter how many powerful interests may be involved.
It will show that the representatives of the American people are not interested in pushing us into a post-human future dominated by what President Vaclav Havel of the Czech Republic has called the arrogant anthropocentrism that so ravaged the previous century.
It will say that we will not turn our children into objects and products of manufacture and design.
It will say that we have said no to the threat of a damaging biogenetic uniformity of the sort that cloning portends.
It will say that we will not permit the emergence of unused productsfailed clonees, poor, misbegotten children of distorted imaginations.
It will say that we are determined to protect and to sustain what we know to be the best context for child nurturea child who is not a product but a precious and unique human being, a child who has not been deprived a unique identity through the terms of its production, but precisely given a unique identity through the terms of its begetting.
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I see, Mr. Chairman, that my time is up. And I hope that I will be able to revisit this and a number of other issues during the question and answer.
[The prepared statement of Ms. Elshtain follows:]
PREPARED STATEMENT OF JEAN BETHKE ELSHTAIN
Good afternoon. Thank you for the opportunity to offer reflections on the political and ethical issues presented by the prospect of human cloning. I am Jean Bethke Elshtain. I teach social and political ethics at the University of Chicago where I am a member of the Divinity School and the Department of Political Science. My work for nearly thirty years now has been devoted to examining the ethical implications of political and social policies and proposals. I consider myself a hard-headed realist, one obliged, therefore, to avoid utopian scenarios that assure us that paradise is just around the corner if only we implement this ideology or enact this policy and, as well, to challenge dark, nightmarish sketches of what the future will hold if a certain proposal is implemented or a technology developed. That said, it seems clear to me that the path down which we are headed unless we intervene now to stop human cloning is one that will deliver harm in abundanceand that harm can be stated clearly and decisively nowwhereas any potential benefits are highly speculative and likely to be achievable through less drastic and damaging methods, in any case. The harms, in other words, are knownnot a matter of speculationwhereas the hypothesized benefits are a matter of conjecture, in some cases rather far-fetched conjecture: this according to the bulk of current scientific opinion.
Page 121 PREV PAGE TOP OF DOC Segment 2 Of 2 One of the basic rules of medicine is also a basic rule of politics: first, do no harm. We are on the pathway to harm. That is why I support H.R. 1644, the ''Human Cloning Prohibition Act of 2001.'' Last August, I was in Berlin, Germany, for an international conference. On that occasion, the Lutheran Bishop of Berlin presented a talk in which he expressed alarm at the direction much of the genetic ideology of the presentnot science, but an ideology that piggy-backs off scientific and technological developments and prospectstends. That ideology increasingly identifies the true essence of what is human with a particular genotype. This ushers into a kind of genetic fundamentalism that reduces our humanity to the clusters of traits we phenotypically exhibit, or fail toeverything from desirable height, hair and eye color, skin color, I.Q., physical attractiveness, and so on. The hope of genetic fundamentalists is that we can increasingly control for that which is deemed desirable and eliminate that which is not. The aim in all this is not to prevent devastating illnesses but precisely to reflect and to reinforce certain societal prejudices in and through genetic selection. There is a word for this so-called 'genetic enhancement'. That word is eugenics. Human cloning belongs to this eugenics project. All the ethical, political, scientific , and juridical arguments against eugenics apply to the prospect of human cloning. Hans Jonas, the distinguished philosopher and scientist, has already written that cloning is ''both in method the most despotic and in aim the most slavish form of genetic manipulation; its objective is not an arbitrary modification of the hereditary material but precisely its equally arbitrary fixation in contrast to the dominant strategy of nature.''
Public policy reflects our understanding of who we are as a people. It indicates where we are going and our appreciation of where we have been. Americans are a strong, but not a reckless people when we are at our best. We are a determined but not a willful people when we are at our best. We are an energetic but not a frenetic people when we are at our best. We are a creative but not a chaotic people when we are at our best. We are a concerned but not a sentimentalist people when we are at our best. We are a realistic but not a narrow-minded people when we are at our best. Banning ill-considered, harmful ventures in human cloning will show us at our best. It will demonstrate that the untrammeled profit motive behind runaway and reckless, by contrast to responsible and controlled, developments in the area of genetics will not be given full sway, no matter how many powerful interests may be involved. It will show that the representatives of the American people are not interested in pushing us into a post-human future dominated by what President Vaclav Havel of the Czech Republic has called the ''arrogant anthropocentrism'' that so ravaged the previous century. It will say that we will not turn our children into objects and products of manufacture and design. It will say that we have said no to the threat of a damaging biogenetic homogenization or uniformity of the sort that cloning portends. It will say that we will not permit the emergence of unused 'products', failed clonees, poor misbegotten 'children' of our distorted imaginations. It will say that we are determined to protect and to sustain what we know to be the best contexts for child nurturea child who is not a product but a precious and unique human being, a child who has not been deprived of a unique identity through the terms of its production but precisely given a unique identity through the terms of its begetting.
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There are those who tell us that banning this harmful procedure is an unacceptable diminution of human freedom. I do not understand the view of freedom they promote. Responsible freedom has never been a notion that we should simply move full steam ahead on whatever strikes our fancy or seems doable or promises profit and glory and newspaper headlines. Freedom is always limited by my presence among others. Rights are never absolute because we are not. Those who claim that to prevent human cloning cuts into an unlimited right to 'reproductive freedom' ignore politics, ethics, and history. All decent societies restrict this freedom and set boundaries to its operation. Banning human cloning would not, in this sense, be unprecedented but well within our established traditions. Authentic freedom and responsibility should never be reliquished in favor of an abstract, ideological claim that feeds and fuels narcissitic imaginings of radical sameness, for one can see in the arguments of those who express enthusiasm for cloning a real fear of the different and the unpredictable, a yearning for a world of guaranteed self-replication. At base such a world flies in the face of everything we know about the importance of bio-diversity and of social and political pluralism. I urge you to pass HR 1644, a bill consistent with our traditions and our sense of who we are as a people when we are at our very best.
Mr. SMITH. Thank you, Professor Elshtain.
STATEMENT OF GERARD BRADLEY, PROFESSOR OF LAW, NOTRE DAME LAW SCHOOL, NOTRE DAME, IN
Page 123 PREV PAGE TOP OF DOC Segment 2 Of 2 Mr. BRADLEY. Mr. Chairman, Members of the Subcommittee, thank you for this opportunity to evaluate the two anticloning bills before you. I propose to evaluate them from both a constitutional viewpoint and also from the viewpoint of criminal law and its enforcement.
My judgment is that bill 1644 is a lawful exercise of Congress's power over interstate commerce and that it is entirely consistent with relevant constitutional doctrines, particularly those protecting privacy and reproductive freedom.
The Greenwood bill is also, in my view, a lawful exercise of Congress's interstate commerce power, though the matter with Greenwood is a little more difficult than with 1644. And the Greenwood bill does raise questions regarding the privacy cases which 1644 does not raise.
But most important, the Greenwood prohibition, in my opinion, is unenforceable. Practically speaking, the bill will not attain its stated objective of banning cloning intended to initiate pregnancy.
My judgment is this: The only effective way to prohibit human reproductive cloning is to prohibit all human cloning, as 1644 does, and it does so free of constitutional difficulty.
I should like to amplify, in these few minutes available to me, two points I make in my prepared testimony.
Page 124 PREV PAGE TOP OF DOC Segment 2 Of 2 One is the Commerce Clause question. It is true that since 1995, starting with the Lopez case, the Supreme Court has engaged in at least some modest pruning of congressional power under the Commerce Clause. Neverthelessand here I shall speak only of 1644I am confident that that bill is free of constitutional difficulty and doubt on the Commerce Clause point.
It's critical at the outset to exactly identify the activity whose relation to interstate commerce is in question. That activity is not precisely somatic cell nuclear transfer. It is, rather, the whole prospective set of activities in connection with human reproductive cloning and with cloning for scientific purposes which would arise in due course absent the prohibition of 1644.
It seems to me that your judgment, if it is your judgment, that this whole prospective market or web of activities in connection with all types of human cloning does substantially affect interstate commerce, if that is your opinion, I believe it is a reasonable view and it is safe from constitutional doubt.
I turn to my second of two points. It's the practical futility of the Greenwood bill's ban on reproductive cloning. I simply don't think it will work.
I have two points in connection with this of my second two main arguments.
One is constitutional, and that is by prohibiting only cloning with the intent to initiate pregnancy, Greenwood may well create a plausible constitutional argument against itself. That is, once any embryos are created, it is at least a plausible constitutional argument that some of them will be implanted or, to put it differently, that some women will have a right to have those embryos implanted.
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I say this especially with regard to a perspective female nucleus donor asking, after a change of mind, perhaps, for her embryos back from a scientific researcher in order to have them implanted in her own womb.
She has a plausible constitutional argument in favor of controlling her reproductive freedom and controlling the terms and circumstances under which she becomes a parent.
And these cases, the cases that are most in point here, are the few cases we have dealing with the resolution of the status of embryos frozen, which are left over in an IVF clinic and a question arises about what to do with them after the couple, which gave the rise to the embryo, was divorced.
I say this, there is at least a plausible constitutional argument that once any embryo is created, parental rights with regard to those embryos are created along with them. If you don't want to create parental rights in the embryos, however created and for whatever purpose, don't create the embryos in the first place.
My second of two points in this regard: I don't think the Greenwood prohibition is practically going to be successful. Note that any embryo created for research purposes is also suited for reproductive purposes. Note also well that the Greenwood bill does not take any position and certainly does not prohibit implantation of embryos. Nor does it make unlawful the mere possession of embryos.
It attaches criminal liability to the point of creation with the intent to initiate a pregnancy.
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In short, the opportunity arisesand this is conduct that would be completely consistent with the Greenwood bill and, therefore, lawfulfor a researcher, having created embryos for research purposes, to have a change of mind and then to make them simply available to someone else, who would then take possession of them, with the intent to implant them and go ahead and implant them in women willing to, if you want to say, rescue these embryos.
That scenario, it seems to me, is not a matter of evading the strictures of the Greenwood bill; that is to say, a kind of undetectable violation of the Greenwood bill. This scenario, it seems to me, is lawful. It is not prohibited by the Greenwood bill.
[The prepared statement of Mr. Bradley follows:]
PREPARED STATEMENT OF GERARD V. BRADLEY
Mr. Chairman and members of the Subcommittee. I am grateful for this opportunity to evaluate the proposed anti-cloning bills, both from a constitutional viewpoint and from the viewpoint of criminal law and its enforcement. A copy of my entire C.V. is attached to the written testimony. I should like to note, however, that I have taught, and published widely, in the areas of constitutional law and criminal procedure throughout my eighteen years as a professor. Before that, I was a prosecutor in New York City, serving as an Assistant to Robert Morgenthau, District Attorney of New York County.
I shall focus principally on H.R. 1644, and especially on its constitutionality. My judgment is that this bill is a proper exercise of Congress' power over interstate commerce, and that it is entirely consistent with relevant constitutional doctrines, particularly those protecting privacy and reproductive freedom. The Greenwood bill is also a legitimate exercise of Congress' interstate commerce power. But it raises serious constitutional questions which H.R. 1644 does not. Moreover, the Greenwood ''prohibition''is unenforceable: practically speaking, the bill will not attain its stated objective of banning cloning intended to initiate a pregnancy. My judgment is this: the only effective way to prohibit human reproductive cloning is to prohibit all human cloning, as H.R.1644 does. And H.R. 1644 provides the route to that end free of constitutional difficulty.
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The Constitutionality of H.R. 1644
The first question about H.R. 1644, as with every act of Congress, is whether a specific constitutional authorization supports the proposed exercise of Congressional power. This bill identifies the Commerce Clause as Congress's lawmaking authority. The controlling Commerce Clause precedents are summarized in U.S. v. Lopez, 514 U.S. 549 (1995). Lopez supplies the criteria for my analysis.
On one view of H.R. 1644, there cannot be any question concerning the Commerce Clause. The bill states that it ''shall be unlawful for any person or entity, public or private, in or affecting interstate commerce'' to engage in any of the prohibited acts. It is possible to read the jurisdictional (i.e., interstate commerce) language here as constituting an element of the offense. On this reading, a successful prosecution under the act would require proof either that the particular defendant's activities (in general) affected interstate commerce, or that the charged act(s) of cloning did. In other words, no one could be convicted under the proposed act without proof of the requisite effect upon interstate commerce. Where that proof failed, the prohibition could not attach. On this view of the bill, no facial attack on commerce clause grounds is possible.
I mention this reading not because I think it is the one intended by the bill's drafters. H.R. 1644 intends, it rather seems to me, a flat prohibition of human cloning, as an exercise of Congressional power over interstate commerce. I turn to the constitutionality of that momentarily. I mention this alternative reading to support the following caveat: if a court down the line, reviewing an enforcement action under the enacted bill, doubts the constitutionality of a flat prohibition, that court will not hold the bill unconstitutional. Instead, that doubting court will adopt the narrower, and safer, reading I just described. Again: there is almost no chance that this bill will be held unconstitutional on Commerce Clause grounds by any court. There is, however, some chance that a court will adopt the safer reading of the jurisdictional language.
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Let us henceforth treat H.R. 1644 as a flat prohibition of human cloning. My judgment is that, even with the modest pruning of Congressional commerce authority in recent Supreme Court cases, the bill is constitutional.
First, there is no doubt that Congress may regulate interstate commerce for non-commercial purposes. Congress may go so far as to prohibit certain activities, in or affecting interstate commerce, solely because they are deemed immoral, injurious to human dignity, or violative of human rights. Many cases support this proposition. The most compelling may be those upholding the Civil Rights Act of 1964, specifically, its ban on racial discrimination in motels and restaurants serving (in even minuscule part) interstate travelers. See Katzenbach v. McClung, 379 U.S. 294 (1964); Heart of Atlanta Motel v. United States, 379 U.S. 241 (1964).
H.R. 1644 prohibits human cloning for a number of reasons, recited in the ''Findings'' section. That most, or even all, may be non-commercial therefore raises no interesting constitutional question.
Does a flat prohibition on human cloning have the requisite connection to interstate commerce? The prevailing Supreme Court tests, as found in the Lopez majority opinion, recognize plenary Congressional power over the instrumentalities of interstate commerce, a protective power extending to intrastate activities which threaten the instrumentalities of interstate commerce. Most of the activity prohibited by H.R. 1644''ship[ping]'' or ''receiv[ing]'' products of human cloning, for examplecould be supported by these twin powers. Congress could, without constitutional question, flatly prohibit all use of the mail and wires in furtherance of human cloning, prohibit all entities receiving any federal funds from human cloning, and even utilize its special maritime and admiralty jurisdiction in aid of a total ban.
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My judgment is, however, that these powers, either alone or in tandem, may not be sufficient to support all that is banned by the bill. My opinion is that some portion of the flat ban on human cloning must rely upon the third type of Congressional commerce power, that over intrastate activity affecting interstate commerce.
The Lopez court emphasized, over against some prior authority, that the test was whether the regulated activity ''substantially'' affects interstate commerce. H.R. 1644 does not use the modifier ''substantial''. But that alone does not affect the bill's constitutionality, so long as it can be shown, in a later judicial test, that a ''substantial'' effect exists. Does Congress have a reasonable basis for asserting that ''substantial'' effect? I surely believe so.
Here is the argument that Congress does. It is important at the outset to exactly identify the activity whose relation to interstate commerce is in question. That activity is not somatic cell nuclear transfer, the scientific act prohibited by H.R. 1644. For that prohibition is merely the means chosen by Congress to forestall a different, much more substantial economic activity: the whole prospective set of activities in connection with human reproductive cloning, and with cloning for more limited scientific, medical, academic purposeswhich would arise in due course absent H.R. 1644.
This projected web of activities would be high tech; it would be dependent upon the interstate transportation of raw materials, lab equipment, and products; and it would rely upon the national and international communication of needs, research results, and opportunities. Though precisely speaking not a commodity for sale, cloned human embryos could reasonably be projected to becomes articles of exchange, traded for ''service'' fees. In short, Congress could reasonably conclude that H.R. 1644 is a pre-emptive strike against a potentially enormous interstate traffic in connection with human cloning.
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The central aim of H.R. 1644 is to forestall this projected commodification of the results of human cloning. Nothing in the Constitution or the case law requires Congress to wait and see how things play out before acting. That Congress is poised to act pre-emptively against an evil is neither unusual nor constitutionally troublesome. True, if the bill succeeds in its goals, we will never know in fine what the unregulated market in human cloning would have looked like. But that fact weighs in favor of constitutionality. For to strike down the bill as unconstitutional, a reviewing court would have to overrule, without any contrary facts in hand, Congress's informed judgment about the future.
In my professional opinion, there is little chance that a court, reviewing a factual basis like the one just described, will upset, as an unwarranted exercise of the interstate commerce power, Congress's judgment to prohibit human cloning,
THE PRIVACY CASES
According to the Supreme Court, its privacy cases have established constitutional protection for the right: to marry; to have children; to direct the education and upbringing of one's children; to marital privacy; to use contraception; to bodily integrity; and to abortion. See Washington v. Glucksberg, 117 S.Ct. 2258, 2267 (1997) (citations omitted). Only two of these rights are in the neighborhood of cloning. For the proposition in favor of a right to ''have children'', the Court relied upon a 1942 decision against involuntary sterilization. For the right to ''marital privacy'' the Court cited Griswold, its 1965 decision in favor a right of married couples to use contraception. There is therefore no Supreme Court authority nearly in line against a ban on human cloning.
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There is, generally, Supreme Court precedent in favor of a woman's right to decide, by herself, whether to ''bear or beget'' a child. But the cases giving rise to that right make clear that ''begotten'' is surely not madeor cloned. And ''bear'' unequivocally refers to the abortion liberty. There is also authority for the proposition that, in no exact sense, one has a right not to be a become a parent against one's wishes. But that right is limited to pregnant women; a man either deceived or the victim of contraceptive failure has no constitutional traction whatsoever upon the decision of the woman to abort their child, or to carry their child to term. Besides, this woman's right is surely asymmetrical. A right not to be a parent does not imply or entail a right, simply, to be a parent.
No case, in any court, has ever held in favor of a constitutional right to reproduction by cloning. In fact, no case has ever held that anyone has a right to reproduce by in vitro fertilization (IVF).
To generate a ''privacy'' argument against H.R. 1644 one would have to go beyond all prior holdings of all the courts. The only way that I can think of to make that argument would detach a commodious phrase, such as the ''right to have children'', from its jurisprudential moorings, and then (somehow) maintain that the broad concept implies a right to reproduce by cloning. But no such argument could possibly succeed, as I understand the Supreme Court's stance towards all such novel claims of constitutional rights.
The Court has repeatedly emphasized two fundamental requirements for any ''privacy'' argument in favor of an unrecognized liberty interest. First, the asserted liberty must be, objectively speaking, ''deeply rooted in this nation's history and tradition''. See Glucksberg at 2268. Cloning clearly does not satisfy this requirement. Not only is it an entirely new technology. By reducing reproduction to asexual replication, it is radically unlike all rights sounding in ''reproductive liberty'' heretofore recognized. In other words, even argument by analogy will not work for cloning.
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Second, the Supreme Court has cautioned, in very strong terms, against arguments relying upon spacious phrasing. The Court has insisted that the asserted liberty be described in specific, concrete terms. Vague, open-ended generalities will not do. For example, the Court has rejected characterizations of its Cruzan holding as favoring a ''right to die''. Instead, the Court, in its own description, held for a ''constitutionally protected right to refuse lifesaving hydration and nutrition''. Nor was Glucksberg itself, according to the Court, about a ''right to die'' or a ''right to commit suicide''. It was instead about ''a right to commit suicide which itself includes a right to assistance in doing so.'' Id.
According to this second requirement, no general ''right to reproduce'', ''to be a parent'', or ''to have a child'' will be credited, either as a conclusion or as a premise, in any argument in the Supreme Court. The Court will insist that a claimant defend a right specifically to cloning. Given the high burden of persuasion imposed by the high Court upon such claimants, the chances of success in the are virtually nil.
The Supreme Court has said: ''We must therefore 'exercise the utmost care whenever we are asked to break new ground in this field'. . .lest the liberty protected by the Due Process Clause be subtly transformed into the policy preferences of the members of this Court''. Id. This statement of judicial restraint implies that ''policy'' is the business of Congress, at least where the Court does not stake a claim to constitutional supervision. The Court has not and, in my judgment, will not, with regard to cloning.
Let me explain, in one more way, why members of Congress are constrained in this matter by their sworn duty to uphold the Constitution and to legislate for the common good, unconstrained by judicial doctrine. It is true that cloning has some features in common with acts that are constitutionally protected. Cloning is, for example, a way to have a baby, and people (women especially) have a right to decide whether to have a baby. Also, let us say for argument sake, that individuals have a right to have babies outside of marriage. (They do, in the limited sense of being immune to penalties for doing so. But individuals do not actually have a constitutional right to unwed parenthood.) Again, you do not have to be married to have baby by cloning.
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But, to observe that cloning is like protected acts in two respects is not saying much. It is not saying much because cloning posses several additional features, and it is precisely those additional features which are the grounds of the proposed banfeatures included in the description of cloning as the asexual manufacture of genetic replicas. We may presume that members of Congress voting for this bill do not do so because they are opposed to people having babies, even outside of wedlock. So far considered, then, members do not adopt as a reason for action any adverse moral judgment upon any act (or feature of an act) declared by courts to be private, or none of Congress's business. Congress, in this thought experiment, regulates only for reasons entirely left open to their policy judgment by the courts. There is no good reason to anticipate authoritative judicial action which would block Congressional action upon those reasons. There is every good reason to conclude that none will be forthcoming.
A comparison might help to make this point clearer. There is no doubt now that movies are a constitutionally protected mode of speech. Individuals therefore may be said to have a right to make movies. And, so long as amenities are preserved, they have a right to make movies about children, using child actors. Francis Ford Coppola, for example, may be said to have a right to do a remake of ''Heidi'', using the Olson twins as stars. Should Congress attempt to suppress this project, so far described, Congress would be acted unconstitutionally.
But, does anyone think that if a particular director wished to make a porno version of ''Heidi'', using child actresses, he has a right to do so? That Congress would be acting unconstitutionally by prohibiting child pornography?
Page 134 PREV PAGE TOP OF DOC Segment 2 Of 2 Of course not, even though porno ''Heidi'' possesses, we may suppose, every feature of Coppola's ''Heidi''. And that is because porno ''Heidi'' possesses one additional featuresexual exploitation of childrenwhich is not constitutionally protected.
Cloning possesses many unprotected features.
A NOTE ON IVF
As I noted above, no court in any American jurisdiction has held in favor of a federal constitutional right to have a child by in vitro fertilization. It is nevertheless permitted in most, if not all, jurisdictions. At least one state court (Tennessee), construing its state constitution, may have implicitly recognized some right to use IVF. Does approval of IVF imply or suggest approval of cloning? Is a ban on cloning somehow inconsistent with approval of IVF? Would a projected court decision in favor of a constitutional right to IVF implicitly undermine the constitutionality of this bill?
The answer to all these questions is ''No''.
IVF and cloning are both methods of asexual human reproduction which rely upon scientific technique to bring an embryo into being. Both techniques require the implantation of the embryo into a woman's womb in order to bring forth a fully developed baby approximately nine months later. But, otherwise, cloning is radically discontinuous with IVF, and much more distant from human reproduction as traditionally morally approved, and as recognized in Due Process cases.
Page 135 PREV PAGE TOP OF DOC Segment 2 Of 2 For: the principle of reproduction in IVF procedures is the human couple. The child born is the issue of two parents, who become mother and father of that child. That child is genetically unique, the unrepeatable combination (genetically speaking) of his/her mom and dad. None of the problems of individuality and identity created by cloning plague IVF. Though assisted by the lab technician, the embryo is created in IVF as it is within the woman's body in intercourse: by the spontaneous fusion of gametesegg and sperm. Most important, because of the unique and spontaneous genetic constitution of the IVF baby, there is scarcely a trace of the manufactured product status that would be characteristic of cloning.
By contrast, cloning is the impersonal, individualized undertaking to make a person to the specifications of a single (genetic) parent. It is replication, not true reproduction, and it is radically de-humanized. The way to think of IVF in relation to cloning is an aggravated form of the relation between the two Heidi movies.
MAY CONGRESS BAN ALL HUMAN CLONING?
My opinion so far has noticed only H.R. 1644, and that insofar as it bans all human reproductive cloning. But H.R. 1644 goes further, and that further step is what most distinguishes it from H.R.(the Greenwood bill). H.R. 1644 would prohibit all human cloning, as the only practical way to make a ban on reproductive cloning effective. The Greenwood bill would instead ban cloning 'with the intent to initiate a pregnancy''. In my opinion, the comprehensive ban of H.R. 1644 raises no new or interesting constitutional questions.(see footnote 4) Also, it is the only practical way to ban reproductive cloning. The Greenwood bill, by contrast, raises difficult constitutional questions, and would be wholly ineffective.
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Let me explain.
The comprehensive ban will obviously curtail the activities of researchers who may have no direct interest in or connection to reproductive cloning. But the judgement that their activities would imperil the ban on reproductive cloning is entirely for Congress to make. Since research of the type involved here is a mixture of speech and act, it is not protected as pure speech is by the Constitution. Congress has the constitutional power to limit these speech acts in the public interest. H.R. 1644 does that.
What new constitutional questions does the Greenwood bill raise? First, by limiting the scope of its prohibition to some fraction of the comprehensive ban of H.R. 1644, Greenwood necessarily weakens the Commerce Clause argument in its favor. Recall that the basis for concluding that H.R. 1644 was on safe interstate commerce ground was the potentially huge interstate traffic in all types of cloning. By prohibiting one subset of cloning Greenwood may have to justify itself by reference to imagined traffic in just that subset. Also,Greenwood does not have the fall-back interpretation available to H.R. 1644. Nothing in Greenwood suggests that ''affecting interstate commerce'' may be an element of each prosecution under it.
By prohibiting only cloning ''with the intent to initiate a pregnancy'' Greenwood creates a plausible constitutional argument against itself. It requires, as a matter of federal law, the intentional destruction of human embryos, which many consider to be incipient human life. The requirement thus creates a constituency who will be both opposed to human cloning, and to the Greenwood bill (for its required destruction of embryos). This constituency will be motivated to locate plaintiffs with standing to save from destruction at least some of those embryos. A nuclear donor, especially a female nuclear donor asking for 'her'' embryos in order to have them implanted in her own womb, has a plausible constitutional argument in favor of a right to do so.
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This female plaintiff will say that, notwithstanding any contractual agreement with researchers, the fact is that her very tiny child now exists, and that the courts have two choices. They may authorize the destruction of her tiny child, or they may restore that tiny child to its mother. She will rely upon the few decided cases involving frozen embryos, derived from IVF, cases usually arising out of conflicts engendered by divorce. Those courts have recognized parental rights in embryos, frozen and in possession of laboratories. Some of these courts were even willing to put aside contractual agreements for the destruction of embryos, in light of parental claims to he embryos. In other words, parents may have the right to change their minds.
Simply put, allow the creation of embryos by anyone for any purpose, and you create parental rights. The only way to avoid creating parental rights is to avoid creating embryos.
The Greenwood ban is not only dubious as a matter of law. It is untenable and unworkable in practice. Sections 8 (a) and (b) of H.R. 1644 provide sound reasons for concluding that evasions of the Greenwood ban would be all but undetectable. I should like to add a different set of observations, not about evading Greenwood, but about the porous quality of its coverage. I shall speak about human reproductive cloning which is not unlawful under the Greenwood bill.
Greenwood does not ban the implantation of embryos obtained by cloning. It does not ban the possession of embryos created by cloning; only knowing ''ship[ping]'' and ''transport[ing]'' the ''cellular product'' of cloning are prohibited. Greenwood explicitly immunizes from its reach ''other medical procedures to assist a woman in becoming or remaining pregnant''. Simply getting pregnant with a cloned embryo is entirely outside the scope of this self-styled ''prohibition against human cloning''. In sum, the Greenwood ''prohibition'' would actually privilege the creation of an untold number of embryos suitable for implantation, and does not make any act in connection with implantation itself unlawful. And a human embryo created for research purposes is just as suitable for implantation as one created for that end, and vice-versa.
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Now consider this very simple, eminently workable scenario.
The act's main prohibition attaches at the moment of cloning. A researcher must not clone ''with the intent to initiate a pregnancy''. A researcher who undergoes a change of heart could therefore lawfully tell another person, whom we shall call the ''mule'', to deliver a vial of embryos (which the researcher had created days ago in good faith) to an office across town. That deliverer would not be guilty of ''knowingly'' shipping or transporting cloning products. Across town, a doctor takes possession of the embryos, and implants them in a like number of women. Neither the doctor or the women are guilty of anything. None created embryos with the intent to cause pregnancy, and none shipped or transported them at all.
H.R. 1644 makes good moral sense, is free of constitutional infirmities, and it is practically enforceable. The Greenwood alternative is morally dubious, constitutionally questionable, and practically unenforceable.
Mr. SMITH. And are you finished, Professor Bradley?
Mr. BRADLEY. Yes, I am, unless you have a question.
Mr. SMITH. Okay, thank you, Professor Bradley. Dr. Okarma.
STATEMENT OF DR. THOMAS OKARMA, PRESIDENT AND CEO, GERON CORPORATION
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Dr. OKARMA. Thank you. Good afternoon, I'm Tom Okarma, president and CEO of Geron Corporation in Menlo Park, California.
Geron is a biopharmaceutical company focused on discovering, developing, and commercializing therapeutic and diagnostic products for applications in oncology, drug discovery, and regenerative medicine.
I'm testifying today on behalf of my company and the Biotechnology Industry Organization, BIO. BIO, as you know, represents over 950 biotechnology companies, academic institutions, State biotechnology centers, and related organizations in all 50 U.S. States and 33 other nations.
Mr. Chairman and Members of the Subcommittee, thank you for the opportunity to testify today at this important hearing on cloning.
In my testimony today, I'd like to make three points. First, Geron Corporation, BIO, and the overwhelming portion of scientists and physicians oppose human reproductive cloning of human beings. On this point, I think we are all in agreement.
However, my second point: In our shared zeal to prevent reproductive cloning, we must not prevent research on tissue cloning, which is fundamental to enable the development of safe and effective cellular transplantation therapies that could revolutionize medicine in our lifetimes.
Page 140 PREV PAGE TOP OF DOC Segment 2 Of 2 My third point is that the objective of this research is to develop a scalable process to enable the direct conversion of a somatic or body cell into a pluripotent cell without consuming oocytes and without generating blastocysts or embryos. Such a process would allow the generation of transplantable replacement cells that would not be rejected by the immune system.
First, ban reproductive cloning. It would be extremely dangerous to attempt human reproductive cloning. As we know, it took over 270 attempts before Dolly was successfully cloned. In fact, in most animals, reproductive cloning has no better than a 3 to 5 percent success rate.
That is, very few of the cloned animal embryos implanted in a surrogate mother animal survive. The others either die in utero, sometimes at very late stages of pregnancy, or die soon after birth. It is simply unacceptable to subject humans to those risks.
To allow human reproductive cloning would be irresponsible. Worse yet, it could lead to a backlash that would stifle the numerous beneficial applications of therapeutic cloning technology, some of which I will describe today, that could lead to cures and treatments for some of our most deadly and disabling diseases.
My second point: It is critical to distinguish use of cloning technology to create a new human being, so-called reproductive cloning, from other appropriate and important uses of the technology, such as cloning specific human cells, genes, and other tissues that do not and cannot lead to a cloned human being, therapeutic cloning.
Page 141 PREV PAGE TOP OF DOC Segment 2 Of 2 The full potential of this technology comes from its applications in regenerative medicine. Many diseases result in the disruption of cellular function or the disruption of tissue. Heart attacks, stroke, diabetes are all example of common conditions in which critical cells are lost to disease.
Today's medicine is completely unable to restore this loss of function. Regenerative medicine, a new therapeutic paradigm, holds the potential to cause an individual's currently malfunctioning cells to begin to function properly again or even to replace dead or irreparably damaged cells with fresh, healthy ones, thereby restoring organ function.
The goal of our regenerative medicine program is to produce transplantable cells that provide these therapeutic benefits without triggering immune rejection of the transplanted cells.
This could be used to treat numerous chronic diseases, such as diabetes, heart disease, stroke, Parkinson's disease, spinal cord injury, and many others.
For example, in our current work, we are learning how to turn the undifferentiated human pluripotent stem cell into human neurons, human liver cells, and human heart muscle cells. So far these cells function normally in vitro, raising the possibility of their application in the treatment of devastating chronic diseases affecting these tissue types.
This would, for instance, allow patients with heart disease to receive new heart muscle cells that would improve cardiac function.
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Cellular cloning techniques are a critical step in the production of sufficient quantities of vigorous replacement cells for the clinical treatment of patients.
Somatic cell nuclear transfer is essential if we are to achieve our goals in regenerative medicine. We must understand the biological properties of the egg cell and the transferred nucleus that cause a differentiated cell to turn into a pluripotent one. This process is called reprogramming, and we're still not sure how it works, which is why we need to continue to perform the research.
At Geron, our aim is to harness and therapeutically apply this biology. Once we fully understand reprogramming, we'll be able to develop specific cells for transplantation without immune rejection. We'll do that by taking a differentiated cell from a particular individual, reprogramming it back to form a pluripotent cell, from which we can produce the differentiated cells we need for transplantation back into that individual. By using the patient's own cells as starting material, we avoid complications due to immune rejection.
This, however, is precisely the research that would be banned by the Weldon bill. Because the Weldon bill does not distinguish between reproductive cloning and use of cloning for research purposes, it will cut off this work and prevent its therapeutic applications from reaching patients.
In contrast, the bipartisan bill introduced by Representatives Greenwood and Deutsch and others bans reproductive cloning but allows the continuation of research. BIO supports Greenwood-Deutsch because it strikes the appropriate balance between prohibiting acts that unsafe and unethical while promoting vital medical research.
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Lastly, it is critical to emphasize that once we understand the molecular biology of reprogramming, we will no longer need to use egg cells or to create blastocysts. The commercial process would transform a somatic cell, such as a skin cell, into a pluripotent cell directly, without the use of oocytes and without the creation of blastocysts.
Moreover, understanding the biology of reprogramming is a critical step to improve the usefulness of so-called adult stem cells. Ironically, the Weldon bill will also be a setback for adult stem cell research.
In conclusion, Mr. Chairman, human reproductive cloning remains unsafe and the ethical issues it raises have not been reasonably resolved. It should be prohibited.
However, as Congress seeks to outlaw reproductive cloning, it must not write legislation that would stop research using cloning technology. Unfortunately, the Weldon bill fails this test. Simply put, enactment of the Weldon bill will stop critical therapeutic work in its tracks. Only Greenwood-Deutsch strikes the right balance.
Thank you, and I would be happy to answer questions.
[The prepared statement of Dr. Okarma follows:]
PREPARED STATEMENT OF THOMAS OKARMA
Good afternoon. My name is Thomas Okarma. I am the President and CEO of Geron Corporation in Menlo Park, California. Geron is a biopharmaceutical company focused on discovering, developing, and commercializing therapeutic and diagnostic products for applications in oncology, drug discovery and regenerative medicine. Geron's product development programs are based upon three patented core technologies: telomerase, human pluripotent stem cells, and nuclear transfer.
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I am testifying today on behalf of my company and the Biotechnology Industry Organization (BIO). BIO represents more than 950 biotechnology companies, academic institutions, state biotechnology centers and related organizations in all 50 U.S. states and 33 other nations. BIO members are involved in the research and development of health care, agricultural, industrial and environmental biotechnology products.
Mr. Chairman, and members of the Subcommittee, thank you for the opportunity to testify today at this important hearing on cloning. Let me start by making our position perfectly clear: BIO opposes human reproductive cloning. It is simply too dangerous technically and raises far too many ethical and social questions.
That's why BIO wrote to President Bush earlier this year and urged him to extend the voluntary moratorium on human reproductive cloning which was instituted in 1997. I would respectfully ask for this letter to be included in the hearing record.
It would be extremely dangerous to attempt human reproductive cloning. It took over 270 attempts before Dolly was successfully cloned. In fact, in most animals, reproductive cloning has no better than a 35% success rate. That is, very few of the cloned animal embryos implanted in a surrogate mother animal survive. The others either die in uterosometimes at very late stages of pregnancyor die soon after birth. Only in cattle have we begun to achieve some improvements in efficiency. However, scientists have been attempting to clone many other species for the past 15 years with no success at all. Thus, we cannot extrapolate the data from the handful of species in which reproductive cloning is now possible to humans. This underlines that this would be an extremely dangerous procedure.
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It is simply unacceptable to subject humans to those risks. Rogue and grandstanding so-called scientists who claim they canand willclone humans for reproductive purposes insult the hundreds of thousands of responsible, reputable scientists who are working hard to find new therapies and cures for millions of individuals suffering from a wide range of genetic diseases and conditions.
The Food and Drug Administration (FDA) has publicly stated that it has jurisdiction over human reproductive cloning experiments and that it will not approve them. BIO supports that view and hopes that the next FDA commissionerwhoever that might bewill assert FDA's current statutory authority forcefully.
There are also many ethical concerns raised by the specter of cloning. As noted in BIO's letter to the President, ''Cloning humans challenges some of our most fundamental concepts about ourselves as social and spiritual beings. These concepts include what it means to be a parent, a brother, a sister and a family.
''While in our daily lives we may know identical twins, we have never experienced identical twins different in age or, indeed, different in generation. As parents, we watch with wonder and awe as our children develop into unique adults. Cloning humans could create different expectations. Children undoubtedly would be evaluated based on the life, health, character and accomplishments of the donor who provides the genetic materials to be duplicated. Indeed, these factors may be the very reasons for someone wanting to clone a human being.''
As you can see, Mr. Chairman, many of these issues strike at the heart of beliefs and values that are inherent in the human condition. What does it mean to be an individual? How should we view our parents, brothers, sisters, and children? How does the world around us influence our intellectual, physical and spiritual development? These are just a few of the questions raised by human cloning. In my view, reproductive cloning would devalue human beings by depriving them of their own uniqueness.
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To allow human reproductive cloning would be irresponsible. Worse yet, it could lead to a backlash that would stifle the numerous beneficial applications of therapeutic cloning technologysome of which I will describe todaythat could lead to cures and treatments for some of our most deadly and disabling diseases.
BENEFICIAL USES OF CLONING TECHNOLOGY
It is critical to distinguish use of cloning technology to create a new human being (reproductive cloning) from other appropriate and important uses of the technology such as cloning specific human cells, genes and other tissues that do not and cannot lead to a cloned human being (therapeutic cloning). These techniques are integral to the production of breakthrough medicines, diagnostics and vaccines to treat many diseases. They could also produce replacement skin, cartilage and bone tissue for burn and accident victims, and result in ways to regenerate retinal and spinal cord tissue.
Let me briefly explaining a cloning technologysomatic cell nuclear transferand how it is used for research purposes. First, the nucleus of an egg cell is removed. In its place, we insert the nucleus of an already differentiated cell (a cell that performs a specific function in the body). Chemicals are added to stimulate the egg to start dividing. At about 35 days, a blastocyst is formed which contains an inner cell mass comprised of undifferentiated, pluripotent cells. These cells are removed and used for research. The research value of these cells is enormous. These stem cells have the potential to form any cell in the body and can replicate indefinitely. Studies in animals demonstrate that this could lead to cures and treatments for millions of Americans who suffer from diseases and disabilities such as diabetes, stroke, Parkinson's Disease, heart disease, and spinal cord injury.
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As exciting as that isit's only a part of the story. The full potential of this technology comes from its use in regenerative medicine.
Many diseases result in the disruption of cellular function or destruction of tissue. Heart attacks, strokes, and diabetes are examples of common conditions in which critical cells are lost to disease. Today's medicine is unable to completely restore this loss of function. Regenerative medicine, a new therapeutic paradigm, holds the potential to cause an individual's currently malfunctioning cells to begin to function properly again or even to replace dead or irreparably damaged cells with fresh healthy ones, thereby restoring organ function.
The goal of Geron's regenerative medicine program is to produce transplantable cells that provide these therapeutic benefits without triggering immune rejection of the transplanted cells. This could be used to treat numerous chronic diseases such as diabetes, heart disease, stroke, Parkinson's Disease and spinal cord injury.
At Geron, therapeutic cloning technology is one of the techniques we use to create pure populations of functional new cells that can replace damaged cells in the body. For example, we are learning how to turn undifferentiated human pluripotent stem cells into neurons, liver cells and heart muscle cells. Thus far, these human replacement cells appear to function normally in vitro, raising the possibility for their application in the treatment of devastating chronic diseases affecting these tissue types. This would, for instance, allow patients with heart disease to receive new heart muscle cells that would improve cardiac function. Cellular cloning techniques are a critical and necessary step in the production of sufficient quantities of vigorous replacement cells for the clinical treatment of patients.
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Somatic cell nuclear transfer research is essential if we are to achieve our goals in regenerative medicine. We must understand the biological properties of the egg cell (and the transferred nucleus) that cause a differentiated cell to turn into a pluripotent cell. This process is called ''re-programming''and we're still not sure how it works. That's why we need to continue to perform research.
At Geron, our aim is to harness and therapeutically apply the power of this biology. Once we fully understand re-programming we will be able to develop specific cells for transplantation without immune rejection. We'll do that by taking a differentiated cell from a particular individual and re-programming it to form a pluripotent cell from which we can produce the differentiated cells we need for transplantation back into that individual. By using the patient's own cells as starting material, we will avoid complications due to immune response rejection.
However, this is precisely the research that would be banned by the Weldon bill. Because the Weldon bill does not distinguish between reproductive cloning and use of cloning for research purposes, it will cut off this work and prevent its therapeutic applications from reaching patients. In contrast, the bi-partisan bill introduced by Reps. Greenwood, Deutsch, and others bans reproductive cloning but allows the continuation of research. BIO supports Greenwood/Deutsch because it strikes the appropriate balance between prohibiting acts that are unsafe and unethical, while promoting vital medical research.
It is important to emphasize that once we understand the molecular biology of re-programming, we will no longer need to use egg cells or create blastocysts. Therefore, this technology is likely to be used only for a short, finite period of time. Moreover, understanding the biology re-programming is a critical step to improve the usefulness of adult stem cells. Ironically, therefore, the Weldon bill will also be a setback to adult stem cell research.
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As the current Congress pursues legislative prohibitions on human reproductive cloning, we urge caution and a distinction between reproductive and therapeutic cloning. We all agree that given the current safety and social factors, human reproductive cloning is repugnant. However, it is critical that in our enthusiasm to prevent reproductive cloning, we not ban vital research, turning wholly legitimate biomedical researchers into outlaws, and thus squelching the hope of relief for millions of suffering individuals.
Our nation is on the cusp of reaping the long dreamed of rewards from our significant investment in biomedical research. The U.S. biotech industry is the envy of much of the world, especially our ability to turn basic research at NIH and universities into applied research at biotech companies and in turn, into new therapies and cures for individual patients. Using somatic cell nuclear transfer and other cloning technologies, biotech researchers will continue to learn about cell differentiation, re-programming, and other areas of cell and molecular biology. Armed with this information, they can eventually crack the codes of diseases and conditions that have plagued us for hundreds of years, indeed, for millennia.
In conclusion, Mr. Chairman, human reproductive cloning remains unsafe, and the ethical issues it raises have not been reasonably resolved. It should be prohibited. However, as Congress seeks to outlaw reproductive cloning, it must not write legislation that will stop research using cloning technology. Unfortunately, the Weldon bill fails that test. Simply put, enactment of the Weldon bill will stop critical therapeutic research in its tracks. Only Greenwood/Deutsch strikes the right balance.
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Thank you for the opportunity to testify. I'll be happy to answer any questions.
Mr. SMITH. Thank you, Dr. Okarma.
It seems to me that there is agreement at least among our witnesses today that reproductive cloning should not be allowed. We have various suggestions, ranging from outright ban to a 3- to 5-year moratorium.
The question, then, is whether we should have reproductive cloning. Three of you all say we should not. Dr. Okarma feels that we should.
What I would like to do, to start with, is, Dr. Okarma, read you some of the statements by Professor Capron and Dr. Elshtain, and ask you respond to what they said in their testimony.
And then I would like you all to respond to what Dr. Okarma says.
Dr. OKARMA. Thank you. I'll be responding extemporaneously. I have not had the opportunity to review the written copy, so I'm responding from my hearing
Mr. SMITH. I'll read you the statement. I hope it won't be out of context and it will give you a feel for what the argument is, and then you could respond, if you would.
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Let's see, Professor Capron, let me read from your statement.
The need for cloning human embryos was simply not established. If anything, the arguments for emphasizing basic research with nonhuman stem cells is even greater in light, for example, of the sad results involving unregulated cellular activity in the brains of some Parkinson's patients who received fetal tissue transplants in experiments in New York and Colorado.
And then in Professor Elshtain's testimony, she said:
It seems clear to me that the path down which we are headed, unless we intervene now to stop human cloning, is one that will deliver harm in abundance, whereas any potential benefits are highly speculative. The harms are known; the benefits are a matter of conjecture.
Dr. Okarma, I gather you feel that research cloning would be beneficial, it might alleviate the suffering of many individuals who have a number of diseases or might suffer those diseases in the future. But how do you respond to the arguments that it doesn't look like the research cloning is that effective or that helpful? And, in fact, recently there has been some doubt cast on it.
Dr. OKARMA. I can respond to that, actually, quite clearly. In point of fact, the demonstration of the ability to produce mouse embryonic stem cells through cloning has been reduced to practice and has been published, so that we know in an animal model of nuclear transfer that one can generate histocompatible cells through the nuclear transfer process that will produce embryonic stem cells that are pluripotent.
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So the notion that this is hypothesis or fanciful thinking is not in fact true. It has been reduced to practice in animals.
However, in fairness, we do not know whether this process is even possible in humans.
To the point that there are other ways to prevent immune rejection, this is also possibly true. And we and others are pursuing them in parallel.
They would, for example, involve genetically altering the embryonic stem cell to render it immunologically null, not recognizable by the immune system. And the notion would be that all cells derived from that engineered cell would also be not recognized.
That requires, however, an enormous leap in the technology. We are asking for a genetic change to be carried through many leaps of production of cells, to breed true, so to speak.
They also could have the disastrous consequence of losing that nullness after the cells were in fact transplanted, leading to a rejection.
So the facts of the matter, as we understand them and as they've been published in peer-review literature, argue that the approach of nuclear transfer would in fact be a final solution to the problem.
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Mr. SMITH. Dr. Okarma, let me interrupt you, because I want to hear from the two professors, as well.
Professor Capron, if you would respond first.
Mr. CAPRON. In the first place, I want to underline what, it seems to me, is a slippery use of the word therapeutic cloning in Dr. Okarma's statement. He uses that to describe not only the creation of research embryos for an eventual therapeutic purpose but cells and so forth. And both the bills before us, as you have heard, are very clear that we are not talking about any prohibitions on the duplication of DNA, the duplication of stem cells and so forth, other kinds of cloning other than the creation of an embryo.
As to the question of whether we need research cloning now in order to achieve results of a therapeutic nature, it seems to me that we have not heard a refutation of the two lines of argument that are presented in the statement.
On the one hand, there is the argument about other ways that need to be explored: the use of adult stem cells and the use of nonclonally derived human stem cells, embryonic stem cells, to see if their antigenicity, and, therefore, their chance of causing a rejection phenomena, can be reduced. And these are both under active research.
Obviously, if either of those pan out, there is no need to use cloned stem cells to create cellular tissues.
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Mr. SMITH. Let me, real quickly, get a response from Dr. Okarma
Mr. CAPRON. Okay.
Mr. SMITH [continuing]. As to that point.
If we get to that point, would you favor a ban, if we get to the point where we didn't need to have those cells?
Dr. OKARMA. Well, it's hard to answer the hypothetical, sir. I think the decision would really turn on its merits. We would really need to know the viability and degree of immune-nullness that cells produced by those alternative methods produced.
Mr. SMITH. Okay, thank you.
Professor Capron, I would like to go to Dr. Elshtain
Mr. CAPRON. Okay.
Mr. SMITH [continuing]. And hear her response as well. Thank you.
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Ms. ELSHTAIN. Thank you, Mr. Chairman.
I ran out of time before I indicated the reasons, the specific reasons, for why I favored H.R. 1644 by contrast to H.R. 2172, and it's quite specifically because it would not create an effective, workable ban on the cloning of human beings for a number of reason, including the fact that the bill permits the use, as we've already heard, of human somatic cell nuclear transfer technology, the act that creates a human clone.
It says only that people are prohibited to do this if they intend to begin a pregnancy. Well, it's easy to see that people would have a stake in saying they intend no such thing as they went ahead with the process and then, through a variety of means, found ways to sidestep the law, the law criminalizing, if you will, an intent.
And one of the things I learned as a graduate student in political science was that legislation is usually not very effective in the business of trying to discern and to punish an intent, that it is in fact acts, it's deeds, over which legislation can be effective. Intent is very difficult, it is very difficult to legislate.
So H.R. 1644 prohibits a specific deed or, in effect, a chain of deeds at the end of which you have a cloned human being. So, in other words, we have to prohibit the creation of embryonic human clones in order to prevent the cloning of human beings.
And it seems to me that H.R. 1644 does that. H.R. 2172 does not, because of the emphasis on intent by contrast to actual deeds or webs. I think Professor Bradley called it webs of activities.
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And the other point I would make is that, in fact, the scenario sketched by Dr. Okarma, or the possible whole panoply of possible therapeutic benefits, again, is highly hypothetical, as he himself indicated, in effect, in his response to you when he said that the scientists at this point didn't even know if some of the techniques that have now been worked, workableare proven to be workable with mice, if those are possible in human beings. And yet we're promised the cure to a whole long list of diseases.
If there are alternative ways to begin to go after some of these devastating conditions and illnesses that do not trail in their wake the harm that human cloning does and the possibility of a technology that is unleashed that will lead inevitably to that result, then that's the direction we should go.
Mr. SMITH. Okay, thank you, Dr. Elshtain.
Professor Bradley, you mentioned in your testimony a few minutes ago the distinction between the two bills and how each bill banned reproductive cloning. You said one was constitutional, one was not constitutional, as I recall.
In any case, what I wanted to ask you was about two constitutional rights that sometimes come into play when we discuss this subject. Do you feel that there is a constitutional right to procreate? And do you think there's a constitutional right to scientific inquiry?
Mr. BRADLEY. Well, first I should say that I think that the Greenwood raises constitutional questions. I'm not sure that I want to be heard to say that it is unconstitutional.
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Mr. SMITH. Okay.
Mr. BRADLEY. But it's not free of constitutional difficulty
Mr. SMITH. Fair enough.
Mr. BRADLEY [continuing]. As I think 1644 is.
Although, as you're suggesting, my conclusion about 1644 includes an opinion about a right to scientific inquiry. I think no such right, you know, just as such exists. And there are rights to pursue unimpeded by Government information and knowledge.
But scientific inquiry, at least in this context, is not a matter of pure speech, because we're talking about research and experimentation. It's a speech act or even principally an act.
So, therefore, the acts that we're talking aboutlet's call them scientific research and experimentare not governed by traditional free speech doctrines, which are themselves not absolutes. Government can regulate speech under certain circumstances. But we're not talking about pure free speech.
So I don't think there is, at least in the relevant sense, a right of free scientific inquiry involved.
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Now, there is somethingor a multifaceted
Mr. SMITH. Professor Bradley, I better stop you there. I am way over time.
Mr. BRADLEY. Okay.
Mr. SMITH. And if you need to return to that later, let me know. But you've really answered my question. And it was a fine distinction you made, and I was glad to hear it. Thank you.
Let me say also that, without objection, all of your statements, complete statements, will be made a part of the record.
The gentleman from California, Mr. Schiff, is recognized for his questions.
Mr. SCHIFF. Thank you, Mr. Chairman.
I wanted to address a question to the three witnesses that testified in opposition to research cloning, as we're describing it today. And I understand that it can be used in different ways, but we're talking about, essentially, human somatic cell nuclear transfer, not for the purpose of pregnancy or to create a child, but for research purposes.
Page 159 PREV PAGE TOP OF DOC Segment 2 Of 2 I've listened to the points you've made, and I have to say that I don't find them all that compelling, and I wonder if there's a reason that we haven't talked about that is more compelling to each one of you.
Professor Capron, you make the point that we need to prevent this because, in the lab, loosely regulated environment, it could be going on for one purpose. It could be then taken and used for an illicit purpose.
And while I suppose that's true, that logic would lead us also to preclude a whole lot of infertility treatments in Irvine, California. And I come from California.
We had a huge problem with people's eggs being sold, and enormous ethical lapses and criminality. Now, we wouldn't preclude those kinds of fertility treatments because of that prospect, and I don't think it would be compelling to do so here.
Dr. Elshtain, you make the point that intent is difficult to legislate, and yet our criminal lawsand this is a criminal law that we're contemplatingare replete with requirements of intent and, in fact, very definite states of intent, depending on the crime.
It is very rare that we find crimes that require no requirement of intent, that are per se violations merely because you conduct a certain act. And I would submit, even as you're proposing, there would be a certain level of intent required.
I also don't think the benefits are all that much a matter of conjecture. And I have to say I put this on the spectrum of things that are not conjecture at all and then, perhaps, national missile defense being more on the speculative side.
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And where this fits within that spectrum, I'm not sure, but I would hate to see us prevent an important medical research opportunity merely because we haven't seen the documented success of it yet when there is so much progress being made.
I found the constitutional theory to be a very interesting one, that the narrower bill has a greater constitutional problem than the broader bill. I'm not sure that's correct. I think it's a very interesting idea.
To the degree any court is going to find that you have a constitutional right to procreate, using different scientific techniques, my guess is, if they're going to find you have that right, and I think at the point we're talking about, it's probably not likely, but if they were going to find you had that right, you probably have the right to go through the cloning process. It wouldn't simply be created once you had undergone part of the process. But I think it's interesting theory.
I think your other point, though, is very well-taken, that there does need to be some tightening up of the bill in that there are certain things precluded, that if there were a mental change along the way might not bar the cloning that we are all attempting to bar.
But I guess what I'm trying to say is that, or what I would like to ask is, of the three of you, if we could see today the measurable benefitsif they were not speculative, if the benefits we knew were real right now in treating Alzheimer's, cancer, a whole host of thingsif we could be certain that it wouldn't be subject to any greater likelihood of risk and that we had great oversight of our laboratories, if there was no greater constitutional threat, would the three of you still be opposed to this type of research cloning simply because you believe that it is immoral and unethical without more?
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Mr. CAPRON. No, I would not. And it seems to me that the issue is, at the moment, what is the correct characterization?
In order to get to the point of therapeutic benefit, we need research that amounts to building blocks. We need research on the differentiation of stem cells, not cloned stem cells, but other stem cells, into tissues and even organs in a way which will reliably function in the human body if transplanted. You don't need cloned research embryos to do that.
We need research on reprogramming. That can be done with animal cells. We don't need cloned human cells to do that.
And as I said, there are other ways that are under research that might offer a way, which I think everybody favors, the commission certainly favored, of avoiding the use of cloned embryos entirely, if we could the therapeutic benefits.
Mr. SCHIFF. Professor, if this was the only way, would you support it?
And I realize
Mr. CAPRON. I said yes, in answer to your question. Yes.
Mr. SCHIFF. And one of the reasons I ask this question is, you know, you've made the point, and the doctor makes it also, that this may be a temporary problem, in that we may find other cells we can use for these purposes 5 or 10 or 15 years down the road.
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And that's wonderful, but for someone who is afflicted now, and you may have seen recently, I think there was a press conference today about Geraldine Ferraro and her use of
Ms. ELSHTAIN. Thalidomide.
Mr. SCHIFF [continuing]. Thalidomide. Exactly.
Very promising in her treatment today. Now, there may be other remedies in 5 years for her. But had it not been for the discovery of the productive use of thalidomide now, she may not live to see those other therapies.
Mr. CAPRON. You answeredI answered your question but Iif I may put it in form of a question: If we do not now have the ability to use cloned research embryos for therapy, if that is, as everyone would say, is speculativeso we're not asking patients to forego a treatment that we now have. If that is speculative, and if, given the examples, like Irvinewe know that there is huge leakage in the whole fertility field.
It's a very entrepreneurial, almost Wild West phenomenon, very different than all the rest of experimental medicine, for reasons that I won't take your time with now.
In that circumstance, doesn't it seem prudent to draw the perimeter around reproductive cloning to include for the moment work which isn't essential now?
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If it gets to be the point of being essential, we could then do it in a limited number of labs, which are specifically producing an organ for a particular patient or a tissue for a particular patient.
Mr. SCHIFF. Professor
Mr. SMITH. Mr. Schiff?
Mr. SCHIFF. Yes.
Mr. SMITH. Let me interrupt you for a minute and apologize to you and to the other Members up here. The 5-minute clock that we have at our desk is working. However, the 5-minute notification devise on the witness table is not. And, therefore, I'm having to keep time as the Chairman.
And even though your 5 minutes has lapsed, I'd like for the witnesses to respond to your question. But I just wanted to let you know that's the reason for the red light that has been constant during all your questions.
Would the other witnesses please respond briefly to Mr. Schiff's question?
Ms. ELSHTAIN. I'll respond to the question of intent, Mr. Schiff, that you raised.
Page 164 PREV PAGE TOP OF DOC Segment 2 Of 2 You indicated that, in fact, legislation deals with intent all the time, and I think you mentioned criminal law and the fact that one evaluates the seriousness in certain kinds of infractions with reference to intent.
But I don't think that I need to remind that you that, in fact, it is not the intent to murder that is against the law, but it is actually murdering someone.
And then, if there is the objective fact of a body, one goes on in the criminalin the phase, the penalty phase, to evaluate the role of intent and so on.
But you're dealing with an objective fact. You're dealing with a deed.
That was my reference point, that it's concrete. It's stopping concrete deeds.
If the intent to murder were a crime, we'd all be in prison
Mr. SCHIFF. Well, the intent
Ms. ELSHTAIN [continuing]. Because all of us, at one point or another
Mr. SCHIFF. The intent
Ms. ELSHTAIN [continuing]. Have harbored
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Mr. SCHIFF. The intent to kill
Ms. ELSHTAIN [continuing]. Murderous thoughts.
Mr. SCHIFF. The intent to kill is an element, and without the element, you never get to the
Ms. ELSHTAIN. That's right.
Mr. SCHIFF [continuing]. The judge and sentencing.
Ms. ELSHTAIN. But the law prohibits the deed.
Mr. SCHIFF. And the
Ms. ELSHTAIN. And that'sand that's precisely what I'm
Mr. SCHIFF. Prohibits the deed with the intent.
Ms. ELSHTAIN. It prohibits thebut by definition, the deed involves the intent because murder is wrongful killing, which already involves an intent. But to anthe objective factI mean, this could get us into a long discussion, obviously.
Page 166 PREV PAGE TOP OF DOC Segment 2 Of 2 The objective fact of a bodyso what I'm saying is that when you say, ''Well, the thing that we're going to criminalize is the intent to, if you will, do harm,'' to lead down this slippery slope, someone can, it seems to me, very effectively evade that by claiming there was no such intent and things simply got out of control.
As Dr. Capron pointed to with the infertility business at the present time, things often get out of control.
When you have the end result, one that everyone acknowledges is harmful, why would you want to take steps that would, it seems to me, inevitably lead to that harm? And Iit seems to me that, in fact, 2172 would lead to that harm or it would do nothing to prohibit it, whereas 1644 would more effectively try to prohibit the harm that everyone at this table, and I think everyone you've heard, probably agrees is a harm.
Mr. BRADLEY. Representative Schiff, I'll try to answer your question as straightforwardly as I can.
I do oppose, for moral reasons, the creation of embryos in order to perform research experiments on them and thenwith the idea of discarding them. But that conviction of mine is not a premise of anything I've said to this Committee today, nor is it a premise of anything in my written remarks.
Mr. SCHIFF. Thank you.
Mr. SMITH. Okay, Thank you, Mr. Schiff.
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The gentleman from North Carolina, Mr. Coble, is recognized for his questions.
Mr. COBLE. Thank you, Mr. Chairman.
And thank you all for being with us.
I say to the panelists, Mr. Chairman, I missed about three-fourths of the testimony. I had to go take a phone call regarding a patent matter on which I am working, so I regret that I didn'twas not privy to most of what was today.
I think you and the gentleman from California pretty thoroughly covered it.
Mr. Okarma, I have been advised by third parties that your corporation has performed outstanding bio work and research, and I will say that to you
Dr. OKARMA. Thank you, sir.
Mr. COBLE [continuing]. Before I make my statement.
I'll say this to the panel, all of whom are experts, it seems to me that this issue conjures up many descriptive words defining the process: contentious, controversial, exciting, explosive, polarizing, complex.
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It is indeed a complex subject matter. Cuts across all sorts of disciplines, some of which are represented here today: medicine, ethics, the law, science, political science.
I have no question, Mr. Chairman, specifically, but to say that I am not a man of letters to the extent that I can delve into this with the expertise that we've heard here, and the expertise that you and the gentleman from California have expressed, for that matter.
But I know that this Subcommittee and the Judiciary Committee as a whole, I am confident, will continue to keep a close lookout, and perhaps, I guess it's fair to say, Mr. Chairman, this may be the first of many steps to follow before the matter is resolved with finality.
And I thank you again for having staged this hearing today and again express my thanks to the panelists for being here.
Mr. SMITH. Thank you, Mr. Coble. And I might say that anyone who serves as Chairman of the Intellectual Property Subcommittee has a lot of intellectual understanding, so you don't need to worry
Mr. COBLE. Thank you, sir.
Mr. SMITH. The gentleman from Virginia, Mr. Goodlatte, is recognized for his questions.
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Mr. GOODLATTE. Thank you, Mr. Chairman, and thank you for holding this hearing.
I agree with much of what my good friend from North Carolina said. I'm not sure about whether we can be as deliberative as we'd like to be.
And I'd like to ask the panel what they can tell us about how imminent it may be that there'll be actual efforts at human cloning where an actual human being is cloned from the embryonic cells that might be cloned.
Start with Professor Capron.
Mr. CAPRON. For a number of years
Mr. GOODLATTE. I've read articles that said
Mr. CAPRON. Right.
Mr. GOODLATTE [continuing]. This could happen, it could be happening right now, so on.
Mr. CAPRON. Yes. Thefor a number of years, various parties have said that they intended to go forward. The statements in the last 6 months by two groups in particular and the funding that they have and apparently, in the case of one of the groups, the willing volunteers, in terms of people to serve as the surrogate mothers, makes it more urgent.
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It's hard to evaluate the credibility. And it is certainly true that on the scientific side, there aremost of the scientific opinion that I have read is that it would not only be highly irresponsible as a form of totally premature experimentation, but probably not successful and perhaps even extremely harmful to the women who were serving in the role.
That does not mean, it seems to me, that we can sit back and say, ''Well, they'll never make it happen,'' or, ''It's a long way off.''
There is every reason to think that
Mr. GOODLATTE. Are there people so unethical that they would be willing to try without theI mean, as I understand it
Mr. CAPRON. They have publicly announced
Mr. GOODLATTE [continuing]. When there has been animal cloning, there have been lots of misfit-type failures that, it would seem to me, you'd be likely to encounter with human cloning as well.
Mr. CAPRON. I think that is the scientific opinion, that it is very likely to encounter exactly those, because of difficulties in the reprogramming of the genetic material when it goes from the somatic cell back to its pluripotent state to begin the organogenisis.
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And it is for these reasons, among others, that the National Bioethics Advisory Commission said that there should be a moratorium on any reproductive cloning.
What I believe, however, is that the groups that have announced have the backing and have the intention to go forward. And I think it would be a great mistake for Congress to rely on the scientific improbability of their success as the protection that we need against the steps that they propose to take.
Mr. GOODLATTE. Dr. Elshtain?
Ms. ELSHTAIN. Yes. Unfortunately, Mr. Goodlatte, as you know, society always contains people who are unethical and people who are driven to garner all kinds of sensationalistic headlines. And this would certainly produce them.
There have been a number of very publicized intentions announced in the press, people who said that if human cloning were banned in the United States that they would move offshore and set up their laboratories and so on.
So I think that we have to takeI quite agree with Dr. Capron. I think we must take these people seriously and I think that these attempts are now under way. I don't think that this is a fantastic, futuristic scenario.
And I think that the prospect of a kind a traffic in cloned embryos with a possibility of trying to bring them to term as human clonees, and the number of failures this would involve, and what kinds of entities would one have, and what would their fates be, I think that is something that one should
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Mr. GOODLATTE. Let me interrupt and ask
Ms. ELSHTAIN [continuing]. Really shudder at.
Mr. GOODLATTE [continuing]. Another question.
Do any of you know, is there an active investigation ongoing by any governmental entity, you know, a law enforcement agency or a consumer protection agency or anybody, a State licensing board for the practice of medicine? Anybody who is investigating these statements made by people and attempting to stop this under any current laws that they might be able to utilize?
Mr. BRADLEY. I'm not aware of any. There wouldn't be any law enforcement cause unless cloning is contrary to the criminal laws of some State that we're talking about. And to my knowledge, few if any States have criminalized cloning.
Mr. GOODLATTE. Dr. Okarma, would you respond to my first question?
Dr. OKARMA. Well, I actually agree with much of what was said a moment ago, and would perhaps extend it in the realm I'm comfortable in, which is the technical end.
These proponents of reproductive cloning, the Raelians and such, make the argument that we are much now like we were at the beginning of IVF, and, therefore, IVF has turned out to be a successful and safe alternative to reproduction, so there's no reason why the cloning nuclear transfer could not also do the same.
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But that obfuscates the very fundamental difference in the biology. IVF is still, although in a test tube, the normal mechanism of procreation of humans. They haploid genomes of egg and sperm joining.
That is not, in fact, what happens somatic cell nuclear transfer. We are asking an oocyte, which has had its own nucleus removed, to completely reprogram an adult nucleus that is only expressing the genes required for that particular tissue, to take that nucleus all the way back to the beginning of development and to recapitulate Mother Nature's tape of development.
That's a huge biological burden for the egg. And, therefore, the likelihood of equal success that is enjoyed by IVF is very low.
Mr. GOODLATTE. Now, as I understand it, the difference between your perspective and the other three witnesses here relates to where you draw the line in terms of what can be done. Is there a clear, bright line that can be drawn?
I very much respect Dr. Elshtain's concern about intent. I think that is a very serious problem here, and I can see people with unethical motives attempting to cover up their intent somehow.
But would the type of research that you're advocating involve the placement of these cells in a woman to carry on the research at all? I mean, is that a line you can draw there, that
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Dr. OKARMA. The research that we advocate absolutely would not do that. We are, in fact, all in agreement to proscribe the transfer of any cloned embryo into a human uterus.
Mr. GOODLATTE. Dr. Elshtain, how wouldit seems to me the law could very clearly say that that was theI'm not advocating this, because I'm inclined to your side of the perspective here, that we shouldn't get into this at all.
But given the arguments of Dr. Okarma and others, that there are medical benefits to be derived from this, is it simply a way of determining what the intent is, to say that if they go across that line and place these into a uterus, that that is the dividing line that would clearly show intent?
Ms. ELSHTAIN. Well, I think that, in fact, there isn't a bright line and there can't be, that sometimes we reallythere really is a slippery slope and this is one.
That is, it seems to me that once you start creating embryonic human clones, that you can imagine a subterranean traffic, if you will, in thosein those clones. And that those who werethe originators of them, so to speak, could deny the intent of creating actual cloned human beings out if it.
But once you start doing that, and doing that en masse, it seems to me that you would start to get this traffic in cloned human embryos.
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Mr. GOODLATTE. It's kind of like nuclear proliferation, is it?
Ms. ELSHTAIN. And it would simplyyeah. And it would be, yes, some kind of genetic equivalent of an arms race. And you would have a situation that really would be out of control.
And I think that's really what must be forestalled at this stage of the game.
Again, I think it's important to emphasize, as my colleagues have, that the Weldon bill does not stop animal cloning or the cloning of human DNA fragments. It doesn't stop duplication of somatic cells. It doesn't stop stem cells and tissue culture research and so on.
So the medical
Mr. GOODLATTE. Let me interrupt you there.
Ms. ELSHTAIN [continuing]. Technology and medical benefits
Mr. GOODLATTE. And, Dr. Okarma, that's enough, all of those other tools still being available?
Page 176 PREV PAGE TOP OF DOC Segment 2 Of 2 Dr. OKARMA. Well, none of those tools speak to the essential issue of trying to prevent immune rejection of the transplanted cells.
And there are some technical subtleties here. It may seem to you that since this is a form of transplantation, much like an organ, why not simply rely on available immunosuppressive drugs, notwithstanding their toxicity and their expense? And the difference is actually quite profound.
Our intent is to transplant small numbers of highly purified cells, which may not survive the toxic side effects of currently available immunosuppressive therapy. That's why there is urgency here in this research.
And one other point I would like to make. While I do really respect and sustain both Dr. Capron and Dr. Elshtain's caveat about over-promising and under-delivering in this technology, I appreciate that point, however neither of them have spent much time in our laboratory, so I can tell you that we do in fact have the data now on differentiation, that the three cell types that we have deliberately chosen to manufacture from the embryonic stem cell, each represent one of the three germ layers of embryonic development, thereby enabling the notion that we can in fact produce any cell from these embryonic stem cells.
Mr. GOODLATTE. And wherewhat is the source of embryonic
Dr. OKARMA. The embryonic stem cell is derived from in vitro fertilized blastocysts that are no longer needed to achieve pregnancy and are donated under informed consent for research.
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These cells are infinitely self-renewing. That means they grow forever in the undifferentiated state, which we have, in fact, documented. And they are pluripotent, meaning because of their derivation from early embryos, they literally grow into all the cells and tissues in our body.
And I would add
Mr. GOODLATTE. The source of this
Dr. OKARMA. We
Mr. GOODLATTE. If I might just interrupt for a second, and then you can finish.
The source of the cells that you use for this purpose are not from fetuses, then?
Dr. OKARMA. That's correct. Although we do have a different technology, the embryonic germ, that is derived from therapeutic abortions. It is somewhat different and has properties that are frankly inferior from a therapeutic perspective from ES cells.
I just would like to make one point in closing about the differentiation argument, about how near and present the technology is. Because we can scalably make these cells, as opposed to the adult stem cellswhich are so rare and slow-growing that you cannot, at this point, produce many of themwe can expose these manufactured cells to rigorous functional testing, just as if they were a monoclonal antibody or a chemical made by a pharmaceutical firm.
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And these cells withstand that scrutiny. They makefor example, the liver cells make all the drug metabolizing enzymes of our livers. The nerve cells make all of the appropriate synaptic materials. We are currently in animal studies with these neurons in animal model of Parkinson's disease and have in fact seen human neurons that we've implanted in this animal making synaptic connections in the damaged part of the brain.
So while I'm not saying that we are ready to initiate a human clinical trial, the data on differentiation and functionality of cells that we manufacture from the ES cells are very solid and are here today.
Mr. GOODLATTE. Thank you, Mr. Chairman.
Mr. SMITH. Thank you, Mr. Goodlatte.
I would like to ask you all a quick question to end on, and it is this: Do you feel that the Food and Drug Administration had the power to regulate cloning or to ban cloning?
Mr. Okarma, I believe you think they do have the power?
Dr. OKARMA. Let me simply answer that question from the perspective of appropriateness in their statements. I'm not a legal scholar, as you know, so I really
Page 179 PREV PAGE TOP OF DOC Segment 2 Of 2 Mr. SMITH. Okay.
Dr. OKARMA [continuing]. Cannot comment on the legal framework for their position. I do think, however, that the FDA is in an informed and appropriately judicial position to do that regulation.
Mr. SMITH. Okay, thank you.
Mr. BRADLEY. No, I would have to say I don't know for sure. If it pleases you, I would be happy to work up something as a response that I would have more confidence in giving to you.
Mr. SMITH. Okay, fair enough. Thank you.
Ms. ELSHTAIN. I'm not sure about whether it has the legal power, but I think the presupposition would be that the embryo is like an ordinary drug, in a sense. And I think that it would bethere would be a substantial problem in treating human embryos in the way that one treats a drug.
Mr. SMITH. That's what I've got as well.
Page 180 PREV PAGE TOP OF DOC Segment 2 Of 2 Professor Capron?
Mr. CAPRON. Well, the FDA asserted, back in October 1998, to the institutional review boards that it had that authority. And it may well have that authority over the embryos as a biologic agent.
But the problem is that the authority they are asserting is something which they have never asserted in the fertility field before, and it is odda lot of the challenges and the doubts that are raised about that authority among legal scholars, who I think pretty uniformly doubt that the present statute has it.
And secondly, that what their authority would be limited to would be entirely issues of safety. So that if researchers establish that there was a wide enough, within the margin of safety, and combined with the arguments that Professor Bradley gave you about people asserting their reproductive rights and treating this as just a fertility method, at that point, it would be very hard, it seems to me, for the FDA to stand in the way.
One other issue about this whole treating this as the FDA, as the Greenwood bill does, it throws a cloak of confidentiality over all the proceedings and treats all the information as proprietary information.
In the cloning field itself, research results that came out early on from the Americanfor the Advanced Cell technology in the use of the cow oocyte as a vehicle for cloning of human nucleus never end up being published. Those are, so far as I know, retained as proprietary information.
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We know from the debacle around some of the dangers with gene transfer that the open body, the recombinant DNA advisory committee, was not getting the information that the FDA was getting about some of the research risks and was holding as a matter or proprietary information.
If we put things in a kind of a registration, leave it to the FDA mode, what we're in effect saying is the public won't know.
Mr. SMITH. Okay. Thank you, all, for those answers.
I want to recognize the gentleman from California, Mr. Schiff, for a request to insert some materials into the record.
Mr. SCHIFF. Thank you, Mr. Chairman. Just to ask that we include a letter received by the Committee from American Society for Reproductive Medicine, and a second letter from the Federation of American Societies for Experimental Biology, and ask that be added to the record.
Mr. SMITH. Without objection, those documents will be made a part of the record.
Mr. SMITH. Thank you all again for your testimony today. This was our second hearing, as I mentioned at the outset. It concludes our series of hearings on the subject, and we will see which bill we consider next.
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But thank you a lot for being here.
We stand adjourned.
[Whereupon, at 5:19 p.m., the Subcommittee was adjourned.]
A P P E N D I X
Statements Submitted for the Hearing Record
PREPARED STATEMENT OF THE HONORABLE SHEILA JACKSON LEE, A REPRESENTATIVE IN CONGRESS FROM THE STATE OF TEXAS
Thank you, Mr. Chairman.
I want to thank Chairman Smith and Ranking Member Scott for holding a hearing on this important public policy matter. With this topic we step into the vast unknown. Cloning is a fascinating, promising issue but one that remains to be more fully explored. It is crucial that Congress carefully consider all options regarding this issue before it proceeds. We must carefully balance society's need for lifesaving scientific research against the numerous moral, ethical, social and scientific issues that this issue raises.
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Just over four years ago, the world learned of the first successful cloning of a sheep, ''Dolly.'' Recognizing the urgent dilemma that this momentous occasion brought, President Clinton wisely instituted an immediate ban on federal funding related to attempts to clone humans. Further, at his request, the National Bioethics Advisory Commission recommended a voluntary moratorium on human cloning. It appears that in this country, this moratorium has been observed, and that human cloning has been discouraged in other nations as well.
It is generally accepted that Americans are not yet comfortable for the reproduction of a human clone. The legal, ethical, physical and psychological implications of such an act are not yet fully understood. The existence of these unresolved questions greatly overwhelms the need to create a cloned human being. We do not yet know the long term health risks for a cloned human being, nor have we even determined what the rights of a clone would be as against the person who is cloned or how either would develop emotionally. Mr. Chairman, we do not seem ready to start down the road of cloning.
What we can accept as a useful and necessary practice, however, is the use of the cloning technique to conduct embryonic stem cell research. This work shows promise in the effort to treat and even cure many devastating diseases and injuries, such as sickle cell anemia, spinal cord damage and Parkinson's disease. This research also brings great hope to those who now languish for years or die waiting for a donor organ or tissue. Yet just as we are seeing the value of such research, there are those among us who would seek not only to stop this research, but also to criminalize it. We must pause for a moment to consider what conduct should be definitely criminalized. There is an irresistable tendency to consider that science will be utilized to bring about undesirable resultsfull human replications.
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Those who support such drastic action will claim that we must do so merely because we do not fully understand it. I contend that quite the opposite action is necessary. We must study what we do not understand. We would not know progress if we were to criminalize every step that yielded some possible negative results along with the positive.
In addition to unknown scientific ramifications of human cloning, we face some legal uncertainties. First, we face the argument that reproductive cloning may be constitutionally protected by the right to privacy. We must also carefully consider whether we take a large step towards overturning Roe v. Wade when we legislatively protect embryos. We do not recognize embryos as full-fledged human beings with separate legal rights, and we should not seek to do so.
There may also be some who seek to impose criminal penalties on cloning in reaction to claims by individuals who are attempting to plunge into the unknown by claiming to be planning to create clones abroad to help infertile couples. But we must throw out the bunch of apples because one in the bunch is bad. The majority who would engage in therapeutic cloning are ethical and would not attempt such negative activity. In fact, research scientists do not have ready access to infertility laboratories, which would be the link needed to complete the reproductive cloning process. And crimininalizing cloning would not deter those who are intent on doing it.
Hence, I am concerned at this time about any legislation that bans cloning, such as H.R. 1644, the Human Cloning Prohibition Act of 2001. The more prudent approach may be that supported by Dr. Shapiro, who advises that Congress refrain from regulating cloning and instead engage in informed regulation.
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Mr. Chairman, I am looking forward to hearing the testimony of the panel of experts on this important topic of cloning and to the dialogue that will ensue as we address this controversial and complex matter. Thank you.
PREPARED STATEMENT OF THE HONORABLE LAMAR SMITH
Today the Subcommittee on Crime holds the second of two hearings on the issue of human cloning. In our last hearing, the Subcommittee focused on the ethical issues and possible consequences of cloning human beings. Today, we will examine the legal issues relating to the federal regulation of human cloning and hear testimony regarding two bills on the issue, H.R. 1644 and H.R. 2172.
Testimony from our last hearing revealed that there are a growing number of groups who claim they can, and will, clone a human being. Currently, no clear regulations exist in the United States that would prevent a private group from attempting to create a human clone. Even though the Food and Drug Administration has asserted that it has the authority to regulate this activity, legal scholars have expressed doubt as to whether this claimed authority would stand a legal challenge. Furthermore, the consequences for any scientist who would ignore the FDA's claimed authority is unclear. For this reason, this Congress must act to protect the health and safety of its citizens.
Legal challenges to any federal regulation of human cloning will be swift. Opponents will argue that any ban on human cloning will be unconstitutional because it unduly interferes with a scientific right of inquiry and denies a person's ''fundamental right to reproductive freedom.'' I believe that these arguments will fail. Although Congress may not prohibit research in an attempt to prevent the development of new knowledge, it may restrict or prohibit the means used by researchers that threaten interests in which the citizens of this country have a legitimate concern. Furthermore, human cloning is not sexual reproduction, it is asexual replication for which there is no guaranteed ''fundamental right.''
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The two bills before us today would prohibit the cloning of human beings, however, the scope of that prohibition is treated in very different and important ways. H.R. 1251, introduced by Congressman Greenwood of Pennsylvania, would only prohibit the use of human cloning technology when the intent of the scientist is to initiate a pregnancy. The prohibition in this bill would still allow for the cloning of human embryos for experimental purposes as long as the scientist creating that embryo does not intend to bring a fully mature human being into existence.
H.R. 1644, introduced by Congressman Weldon of Florida, goes beyond the Greenwood bill and prohibits the use of human cloning technology to produce a living human organism at any stage of development. The Weldon bill would make it a criminal act to clone a human embryo even if the scientist had no intention of trying to initiate a pregnancy.
I should point out that neither of these bills place any restrictions on the use of cloning technology to clone molecules, DNA, cells, tissues, organs, plants or animals. They would not interfere with the use of in vitro fertilization, the administration of fertility-enhancing drugs, or the use of other medical procedures to assist a woman in becoming or remaining pregnant.
Today we will hear from a panel of four witnesses who have extensive backgrounds in the field of law and bioethics. I would like to thank the witnesses for appearing before the Subcommittee on this important issue and I look forward to hearing their testimony. The Chair now recognizes Bobby Scott, the ranking Member for an opening statement.
Material Submitted for the Hearing Record
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POST HEARING QUESTIONS AND ANSWERS
FROM THE HONORABLE SHEILA JACKSON LEE
1. Dr. Leon Kass, Professor of Bioethics, the University of Chicago:
Isn't it likely that even if human cloning is banned, there are some who will engage in it anyway, unregulated?
Doesn't the prohibition of embryonic cloning have the secondary effect of defining an embryo as a life, and thereby outlawing abortion?
2. Dr. David Prentice, Professor of Life Sciences, Indiana State University:
Nobel laureate and Caltech President David Baltimore, along with Stanford University researcher Irving Weissman have stated that a moratorium on the use in research and transplantation of fetal or embryonic stem cells would be ''devastating'' as it is likely that only fetal or embryonic stem cells have the capacity generate a number of specific tissues. The National Bioethics Advisory Commission has also described the use of adult stem cells as scientifically and technically limited. How do you respond to these statements?
Have the adult stem cells been used successfully in treatment for sickle cell anemia? If not, have embryonic stem cells?
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3. Dr. Daniel Callahan, Director of International Programs, Hasting Center:
You have stated ''too much of the current research drive is fueled by a single minded passion to eradicate disease.'' Eradication of disease and consequent improvement of the human condition are the primary purposes of health research.
4. Dr. Robyn S. Shapiro, Professor of Bioethics, Medical College of Wisconsin:
You have opposed criminalization of cloning and endorsed a voluntary moratorium on it.
Does the rapid pace at which technology changes render it difficult for legislators to criminalize cloning. Why?
What is your response to the debate over the success and progress of embryonic stem cell research versus adult stem cell research?
To what extent do you support regulation of cloning? Would you be more likely to support regulation through Congress or the Food and Drug Administration?
5. Question to all witnesses:
How would criminalizing both reproductive and research cloning affect treatment and prevention of infertility and research into new contraceptive technologies?
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Question 1: You have stated ''too much of the current research drive is fueled by a single minded passion to eradicate disease.'' Eradication of disease and consequent improvement of the human condition are the primary purposes of health research. Please explain your comments.
First, the passion to combat disease is often pressed at the expense of other values, as if the conquest of disease is the highest of human obligations. It is not, but simply one of many obligations. Too much of the talk, say, of therapeutic cloning or embryonic stem cell research treats the conquest of disease as trumping all moral values. There seems to be almost a systematic effort to disabuse people of their ethical scruples in the name of medical research.That is wrong. Those scruples are just as important as research, and ought not to be put aside in the name of research.
Question 2: How would criminalizing both reproductive and research cloning affect treatment and prevention of infertility and research into new contraceptive technologies.
Second, well before the idea of therapeutic cloning was even thought of, there were many research possibilities for the relief of infertility being pursuedand there are many still. It is a mistake to assume that, without therapuetic cloning, no further medical progress is necessary. That is wrong. The NIH and the private sector have all kinds of non-cloning research underway. Therapuetic cloning is one possible route to the development of new contraceptives and the relief of infertilitybut is only one route; there are many others.
ANSWERS TO THE HONORABLE SHEILA JACKSON LEE FROM LEON R. KASS, M.D.
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Question 1: Isn't it likely that even if human cloning is banned, there are some who will engage in it anyway, unregulated? Doesn't the prohibition of embryonic cloning have the secondary effect of defining an embryo as a life, and thereby outlawing abortion?
A ban on cloning will not guarantee that it will never be done, any more than a ban on murder or incest prevents all cases of these crimes. But the ban will surely curtail all attempts by all reputable scientists and physicians, and will strongly deter even the rogues from doing it, or at least standing up to claim the credit and notoriety that they are seeking. It will also deter prospective clients from seeking to clone. We must remember that the law also functions as a teacher in these matters, setting forth the community's deep valuesjust as it does in outlawing slavery, hate crimes, and child abuse. It is also not true that if we ban cloning the practice will go off-shore. Many other nations have already banned cloning and regard us as an outlaw nation in this respect. American leadership now will help galvanize the international community in developing a powerful deterrent to human cloning everywhere.
To the second part of the question, the answer is NO. The ban on creating the embryonic clones does not ban the use of existing embryos for research, nor does it even ban the creation of such embryos by means other than somatic cell nuclear transfer. The ban simply tries to stop the cloning activity at its startat the most difficult step and the one where we have the best chance of controlling this matter. The fact that the NARAL is not opposed to this ban and that vigorous pro-choice advocates have testified for the strict ban indicates that this is a far-fetched concern.
Question 2: How would criminalizing both reproductive and research cloning affect treatment and prevention of infertility and research into new contraceptive technologies.
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Such treatment and research will be unaffected. The proposed ban is very carefully drafted so as not to affect IVF or any other (non-cloning) means of helping a woman become pregnant. Research seeking new contraceptive techniques does not require CLONED embryos, and the law is silent on research using embryos derived by IVF. It simply bans the production of clones.
ANSWERS TO THE HONORABLE SHEILA JACKSON LEE FROM ROBYN S. SHAPIRO
Question 1: Does the rapid pace at which technology changes render it difficult for legislators to criminalize cloning? Why?
It is likely that any statute that might be enacted to criminalize human cloning would be quickly outpaced by technological advances. As an example, California's statute prohibiting cloning adopts a definition of cloning that uses the term ''human'' enucleated egg.(see footnote 5) This statutory cloning prohibition could be evaded by use of a cow's enucleated egg to incubate the nucleic DNA of a humana procedure that appears entirely feasible in light of University of Wisconsin researchers' success in using enucleated cow eggs as incubators for other mammalian species' nucleic DNA.
Question 2: What is your response to the debate over the success and progress of embryonic stem cell research versus adult stem cell research?
While studies have reported the successful use of adult stem cells, there are three important reasons to also advance embryonic stem cell research.
Page 192 PREV PAGE TOP OF DOC Segment 2 Of 2 First, it is not clear that adult stem cells can give rise to the variety of tissue types that embryonic stem cells can.
Second, on account of greater difficulties in harvesting and culturing sufficient numbers of adult stem cells that are appropriate for transplantation, the utility of embryonic stem cell therapy is likely to be much greater than that of adult stem cell therapy. Any attempt to use stem cells for treatment of an adult's own body would require harvesting the stem cells from the patient (which is technically difficult and can be painful and risky) and then growing them in culture in sufficient numbers to obtain adequate quantities for treatment. For some rapidly progressing disorders, there likely would not be sufficient time to grow enough cells to use for treatment. In addition, with respect to disorders caused by a genetic defect, the genetic error likely would be present in the patient's stem cells, making them inappropriate for transplantation. Also, adult stem cells may contain more DNA abnormalities caused by exposure to daily living (e.g. sunlight, toxins, etc.) than are found in embryonic stem cells.
Finally, even if adult stem cell research is seen in the most positive light, true scientific progress demands that we proceed with both. Unless all stem cell types are studied, the differences between adult stem cells and embryonic stem cells simply will not be known. As the NIH has said: ''[G]iven the enormous potential of stem cells to the development of new therapies for the most devastating diseases, it is important to simultaneously pursue all lines of promising research. It is possible that no single source of stem cells is best or even suitable or usable for all therapies. . . In order to determine the very best source of many of the specialized cells and tissues of the body for new treatments and even cures, it is vitally important to study the potential of adult stem cells for comparison to that of stem cells derived from embryos and fetuses. Unless all stem cell types are studied, the differences between adult stem cells and embryo and fetal-derived stem cells will not be known.''
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Question 3: To what extent do you support regulation of cloning? Would you be more likely to support regulation through Congress or the Food and Drug Administration?
Physical safety concerns as well as potential psychological and social harms from reproductive cloning indicate the need for regulation. Regulation through the Food and Drug Administration is preferable because regulation through Congress would open important aspects of scientific development to a political tug-of-waras has been the case with debates about fetal tissue and embryo research. The risk is the creation of laws that cover too much for reasons that have nothing to do with human cloning, and that make it impossible to attain the promises of the technology.
Question 4: How would criminalizing both reproductive and research cloning affect treatment and prevention of infertility and research into new contraceptive technologies?
Scientists believe that the creation of research embryos may be the only way to conduct certain kinds of research, such as research into the process of human fertilization. Moreover, aside from this specific research use of cloned embryos, as a more general matter, a ban on research cloning could greatly inhibit embryonic stem cell research. While today there are an estimated 100,000 embryos in frozen storage (some of which will be used for privately-funded stem cell research), as in vitro fertilization techniques improve (e.g., as we acquire the ability to freeze oocyctes), it is possible that the supply of embryos for stem cell research from this source will dwindle.
ANSWERS TO THE HONORABLE SHEILA JACKSON LEE FROM DR. DAVID PRENTICE
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Question 1: Nobel laureate and Caltech President David Baltimore, along with Stanford University research Irving Weissman have stated that a moratorium on the use in research and transplantation of fetal or embryonic stem cells would be ''devastating'' as it is likely that only fetal or embryonic stem cells have the capacity to generate a number of specific tissues. The National Bioethics Advisory Commission has also described the use of adult stem cells as scientifically and technically limited. How do you respond to these statements?
Despite the exaggerated claims, it is much more likely that adult stem cells (including cord blood and placental stem cells) will be the ones to provide all therapeutic treatments for patients. In debates, several proponents of embryonic stem cell research have admitted that this will be the case, and that the desire for human embryonic stem cells will be for basic research purposes only. And in fact, very few specific tissues have actually been derived from embryonic stem cells, and even those are not pure cultures but contain only a few percent of the desired cell type mixed with many other types, as well as growing cells which are known to contribute to tumor formation when injected into animals.
Indeed, the actual statement from the National Bioethics Advisory Commission in September of 1999 was that ''In our judgment, the derivation of stem cells from embryos remaining following infertility treatments is justifiable only if no less morally problematic alternatives are available for advancing the research. . . . The claim that there are alternatives to using stem cells derived from embryos is not, at the present time, supported scientifically. We recognize, however, that this is a matter that must be revisited continually as the demonstration of science advances.'' Since that time, the vast majority of advances have been made with adult stem cells, and all clinical treatments have used adult stem cells. Even proponents of embryonic stem cell research such as Dr. Douglas Melton of Harvard now admit, for example, that ''bone marrow stem cells probably can form any cell type.''
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Question 2: Have adult stem cells been used successfully in treatment for sickle cell anemia? If not, have embryonic stem cells?
Yes, adult stem cells have been used successfully for treatment of sickle cell anemia (see sample references below). Embryonic stem cells have not yet been used to treat ANY patients for ANY disease.
Steen, RG et al.; ''Improved cerebrovascular patency following therapy in patients with sickle cell disease: initial results in 4 patients who received HLA-identical hematopoietic stem cell allografts''; Annals of Neurology 49(2), 222229; Feb. 2001.
Gore, L et al., ''Successful cord blood transplantation for sickle cell anemia from a sibling who is human leukocyte antigen-identical: implications for comprehensive care'', Journal of Pediatric Hematology and Oncololgy 22(5), 437440; Sep-Oct, 2000
Question 3: How would criminalizing both reproductive and research cloning affect treatment and prevention of infertility and research into new contraceptive technologies?
Criminalizing human cloning of any type would have no effect whatsoever on research or treatment of infertility or contraception. Cloning is totally unnecessary to further such research.
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[NOTE: Additional material submitted for the Hearing Record is not reprinted here but is on file with the House Judiciary Committee. The material referred to is listed below.]
Cloning Human Beings, Volume I, Report and Recommendations of the National Bioethics Advisory Commission, Rockville, MD, June 1997
Ethical Issues in Human Stem Cell Research, Volume I, Report and Recommendations of the National Bioethics Advisory Commission, Rockville, MD, September, 1999
(Footnote 4 return)
This is probably the best place to note a shortcoming of draftsmanship in H.R. 1644. It omits all explicit mention of mens rea. This omission appears to make its provisions binding in strict liability. Since the ten-year sentence authorized strongly suggests that either knowing, or perhaps reckless, misconduct is the target of the bill, some mens rea should be made explicit.
(Footnote 5 return)
Cal. Bus. & ProfCode §2260.5