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SUBCOMMITTEE ON CRIME
COMMITTEE ON THE JUDICIARY
HOUSE OF REPRESENTATIVES
ONE HUNDRED SEVENTH CONGRESS
H.R. 1644 and H.R. 2172
JUNE 7 AND JUNE 19, 2001
Serial No. 40
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Printed for the use of the Committee on the Judiciary
Available via the World Wide Web: http://www.house.gov/judiciary
COMMITTEE ON THE JUDICIARY
F. JAMES SENSENBRENNER, JR., WISCONSIN, Chairman
HENRY J. HYDE, Illinois
GEORGE W. GEKAS, Pennsylvania
HOWARD COBLE, North Carolina
LAMAR SMITH, Texas
ELTON GALLEGLY, California
BOB GOODLATTE, Virginia
STEVE CHABOT, Ohio
BOB BARR, Georgia
WILLIAM L. JENKINS, Tennessee
ASA HUTCHINSON, Arkansas
CHRIS CANNON, Utah
LINDSEY O. GRAHAM, South Carolina
SPENCER BACHUS, Alabama
JOE SCARBOROUGH, Florida
JOHN N. HOSTETTLER, Indiana
MARK GREEN, Wisconsin
RIC KELLER, Florida
DARRELL E. ISSA, California
Page 3 PREV PAGE TOP OF DOC Segment 1 Of 2 MELISSA A. HART, Pennsylvania
JEFF FLAKE, Arizona
JOHN CONYERS, Jr., Michigan
BARNEY FRANK, Massachusetts
HOWARD L. BERMAN, California
RICK BOUCHER, Virginia
JERROLD NADLER, New York
ROBERT C. SCOTT, Virginia
MELVIN L. WATT, North Carolina
ZOE LOFGREN, California
SHEILA JACKSON LEE, Texas
MAXINE WATERS, California
MARTIN T. MEEHAN, Massachusetts
WILLIAM D. DELAHUNT, Massachusetts
ROBERT WEXLER, Florida
TAMMY BALDWIN, Wisconsin
ANTHONY D. WEINER, New York
ADAM B. SCHIFF, California
PHILIP G. KIKO, Chief of Staff-General Counsel
JULIAN EPSTEIN, Minority Chief Counsel and Staff Director
Subcommittee on Crime
LAMAR SMITH, Texas, Chairman
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HOWARD COBLE, North Carolina
BOB GOODLATTE, Virginia
STEVE CHABOT, Ohio
BOB BARR, Georgia
ASA HUTCHINSON, Arkansas,
RIC KELLER, Florida
ROBERT C. SCOTT, Virginia
SHEILA JACKSON LEE, Texas
MARTIN T. MEEHAN, Massachusetts
WILLIAM D. DELAHUNT, Massachusetts
ADAM B. SCHIFF, California
JAY APPERSON, Chief Counsel
SEAN MCLAUGHLIN, Counsel
ELIZABETH SOKUL, Counsel
BOBBY VASSAR, Minority Counsel
C O N T E N T S
June 7, 2001
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June 19, 2001
HUMAN CLONING PROHIBITION ACT OF 2001 AND THE CLONING PROHIBITION ACT OF 2001
June 7, 2001
The Honorable Lamar Smith, a Representative in Congress From the State of Texas, and Chairman, Subcommittee on Crime
The Honorable Ric Keller, a Representative in Congress From the State of Florida
Mr. Leon Kass, Professor of Bioethics, The University of Chicago
Mr. Daniel Callahan, Director of International Programs, Hasting Center, Garrison, NY
Page 6 PREV PAGE TOP OF DOC Segment 1 Of 2 Mr. David A. Prentice, Ph.D., Professor of Life Sciences, Indiana State University
Mr. Robyn S. Shapiro, Professor of Bioethics, Medical College of Wisconsin
June 19, 2001
The Honorable Lamar Smith, a Representative in Congress From the State of Texas, and Chairman, Subcommittee on Crime
The Honorable Adam B. Schiff, a Representative in Congress From the State of California
Mr. Alex Capron, Professor of Law and Medicine, University of Southern California School of Law, Los Angeles, CA
Page 7 PREV PAGE TOP OF DOC Segment 1 Of 2 Ms. Jean Bethke Elshtain, Professor of Social and Political Ethics, The University of Chicago, Chicago, IL
Mr. Gerard Bradley, Professor of Law, Notre Dame Law School, Notre Dame, IN
Dr. Thomas Okarma, President and CEO, Geron Corporation
Statements Submitted For The Record
June 7, 2001
The Honorable Bob Barr, a Representative in Congress From the State of Georgia
The Honorable Sheila Jackson Lee, a Representative in Congress From the State of Texas
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The Honorable Lamar Smith, a Representative in Congress From the State of Texas
Material Submitted For The Record
June 7, 2001
Post Hearing Questions and Answers from the Honorable Sheila Jackson Lee
George Will's Article From The Washington Post on ''Human Cloning a Major Threat'' dated, Monday, January 22, 2001
June 19, 2001
Letter From American Society for Reproductive Medicine
Letter From the Federation of American Societies for Experimental Biology
Newsletter from the United States Catholic Conference
Letter From National Bioethics Advisory Board
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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
THURSDAY, JUNE 7, 2001
House of Representatives,
Subcommittee on Crime,
Committee on the Judiciary,
The Subcommittee met, pursuant to notice, at 11 a.m., in Room 2237, Rayburn House Office Building, Hon. Lamar Smith [Chairman of the Subcommittee] presiding.
Mr. SMITH. The Subcommittee on Crime will come to order. We appreciate the great interest this hearing has attracted, and I want to say by way of an announcement at the outset that we do not expect any votes for the next hour, so we should be able to proceed uninterrupted. Also, I want to mention that the Ranking Member, Bobby Scott of Virginia, is in another Subcommittee meeting and will be late, otherwise we would be waiting for him before we started. We do appreciate the attendance of the gentleman from Florida, Mr. Rick Keller, and we expect other Members to join us shortly, as well. I am going to recognize myself for an opening statement and other Members, if they have opening statements, and then I will introduce the witnesses and we will proceed with our hearing.
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Today the Subcommittee on Crime holds the first of two hearings on the issue of human cloning. We all recognize that biotechnology has enhanced our lives in many ways, and I am a strong supporter of it, but there are some lines that we should not cross. Our efforts to improve humanity should never devalue humanity. The theoretical ability to clone humans raises profound moral and ethical issues. Since reports indicate that scientists and physicians are soon planning to produce the first human clone, it is critical that Congress examine whether or not this type of experimentation should be allowed to proceed.
This hearing will focus on the ethical issues and the possible consequences of cloning human beings. The second hearing will examine the legal issues relating to Federal regulation of human cloning. The issue of human cloning came to the public's attention first when scientists announced they had successfully cloned Dolly, the sheep, in February 1997. A February, 2001 Time-CNN poll found that 90 percent of all Americans oppose cloning humans. The science of cloning has advanced rapidly since 1997. Scientists have successfully cloned monkeys, cattle, pigs, mice and other animals. Because of this, there are a growing number of groups who claim they can and will clone a human being.
We should not rush to prove what can happen until we first consider whether it should happen. How does the scientific community define a successful cloning experiment? Scientists often downplay the fact that the cloning failure rate is extremely high. It took 277 stillborn, miscarried or dead sheep to make one Dolly. That failure rate has remained steady since 1997. Even if human cloning were ethically acceptable, it should not cost even one human life. The most celebrated cloning experiment failed 277 times before succeeding. The National Bioethics Advisory Commission has stated that such a failure rate is morally unacceptable.
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What happens to those who survive? Attempts to clone human beings could carry massive risks of producing unhealthy, abnormal and malformed children. If scientists successfully create a Brave New World, will we lose our humanity along the way? Proponents of human cloning argue that the possible benefits for mankind outweigh the concerns. One of the issues that will be addressed today is whether or not there are alternative means available to obtain some of the medical benefits claimed for human cloning. Cloning arguably is a product of manufacturer, not the result of procreation.
The manufacture of human beings is a proposition that alarms an overwhelming majority of Americans. Today, we will hear from a panel of four witnesses who have extensive backgrounds in the field of bioethics, and I thank the witnesses in advance who are coming before the Subcommittee today and, certainly, we all look forward to your testimony. I will now recognize any other Member who has an opening statement. Does the gentleman from Florida have an opening statement?
Mr. KELLER. Thank you, Mr. Chairman. I would just like to take a few seconds to acknowledge and recognize and appreciate my colleague from Florida, Dr. Weldon, for his outstanding work in this area, also to thank the witnesses on both sides of the issue for coming and educating folks like me on this cutting-edge issue. I yield back, Mr. Chairman.
Mr. SMITH. Thank you, Mr. Keller. You were right to do so. I see our colleague, Dave Weldon, in the second row, and we appreciate his attendance here as well. Let me introduce the witnesses and we will proceed: Dr. Leon Kass, Professor of Bioethics at the University of Chicago; Dr. Daniel Callahan, Director of International Programs, Hastings Center, Garrison, New York; Dr. David Prentice, Professor of Life Scientists, Indiana State University; and Dr. Robyn S. Shapiro, Professor of Bioethics, Medical College of Wisconsin.
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We welcome you all and we will begin with Dr. Kass.
STATEMENT OF LEON KASS, PROFESSOR OF BIOETHICS, THE UNIVERSITY OF CHICAGO
Dr. KASS. Thank you, Mr. Chairman and Members of the Committee. My name is Leon Kass and I have been, for over 30 years, concerned with the ethical implications of biomedical advance. Originally trained in medicine and biochemistry, I remain enthusiastic about biomedical research and its promise to cure disease and relieve suffering, yet it has been obvious for some time that new biotechnologies are providing powers to intervene in human bodies and minds in ways that threaten fundamental changes in human nature and in the meaning of our humanity.
These technologies have now brought us to a crucial fork in the road, where we are compelled to decide whether we wish to travel down the path that leads to the Brave New World, and that, and nothing less, I submit, is what is at stake in your current deliberations about what whether we should tolerate the practice of human cloning. I am here to testify in favor of a national ban on human cloning and, in particular, in favor of H.R. 1664, the Human Cloning Prohibition Act of 2001 for two reasons.
First, I believe that human cloning is unethical, both in itself and in what it surely leads to; and secondly, I believe that this bill offers us the best, indeed, the only reasonable chance of preventing human cloning from happening. The vast majority of Americans object to human cloning, and on multiple grounds. In my written testimony, I have outlined these. This is just the summary. It constitutes unethical experiments on the child to be, it threatens identity and individuality, it represents a giant step toward turning procreation into manufacture, especially when understood as the harbinger of genetic manipulations to come, legitimizing in advance the eugenic redesigning of our children according to our specifications. It is a radical form of parental despotism and of child abuse. Permitting human cloning means saying yes to the dangerous principle that we are entitled to determine and design the genetic makeup of our children.
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If we do not wish to travel down this eugenic road, an effective ban on cloning human beings is needed and needed now before we are overtaken by events. The majority of Members in Congress, I believe, are, like most Americans, opposed to human cloning, but opposition is not enough. For if we do nothing about it, we shall have human cloning and we shall have it soon. Our failure to try to stop human cloning and by the most effective means will, in fact, constitute our tacit approval. What, then, is the most effective way to ban reproductive human cloning?
Two legislative bans competed with each other last time Congress considered this matter. One bill would have banned only so-called reproductive cloning by prohibiting the transfer of a cloned embryo to a woman to initiate the pregnancy. The other bill would have banned all cloning by prohibiting the creation even of the embryonic human clones. Both sides opposed reproductive cloning, but because of the divide over the question of embryo research, we got no ban at all. It would be tragic if we again failed to produce an effective ban on cloning human beings, especially now that certain people are going ahead with it and defying us to try to stop them.
A few years ago, I was looking for a middle way between the two alternatives that failed us last time. But, I am now convinced that we need an all-out ban on human cloning, including the creation of the embryonic human clones. I submit that anyone who is truly serious about preventing human reproductive cloning must seek to stop the process from the beginning, and here is why.
Once cloned embryos are produced and available in laboratories and assisted reproduction centers, it will be virtually impossible to control what is done with them. Stockpiles of cloned human embryos could be produced and bought and sold in the private sector without anybody knowing it. Efforts at clonal reproduction would take place out of sight, within the privacy of the doctor-patient relationship, making outside scrutiny extremely difficult. Moreover, a ban on only reproductive cloning will turn out to be unenforceable. Should the illegal practice be detected, governmental attempts to enforce the reproductive ban would run into a swarm of practical and legal challenges, both to any efforts aimed at preventing transfer to the woman, and even worse, to efforts seeking to prevent birth after the transfer has occurred. Should an ''illicit clonal pregnancy'' be discovered, no Government agency is going to compel the woman to abort the clone, and there would be an understandable swarm of protest, should she be fined or jailed before she gives birth.
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For all these reasons and others that I elaborate on in the written testimony, the only practically effective and legally-sound approach is to block human cloning at the start, at the production of the embryonic clone. Such a ban can be rightly characterized not as interference with reproductive freedom, nor even as an interference with scientific inquiry, but as an attempt to prevent the unhealthy, unsavory and unwelcome manufacture of and traffic in human clones.
The bill introduced by Dr. Weldon and his nearly 100 co-sponsors is, in my view, extremely carefully drafted, and its substantial criminal and monetary penalties will shift the incentives for renegades who are tempted to proceed. The bill makes very clear that there is to be no interference with the scientifically and medically useful practices of animal cloning or the cloning of human DNA fragments, somatic cells, or stem cells and tissue culture. Moreover, if enacted, this bill would bring the United States into line with the already, and soon to be enacted, practices of other nations. In collaboration with those efforts, it offers us the best and, I think, the only realistic chance we have of keeping human cloning from happening or happening much.
The issue of cloning is most emphatically not an issue of pro-life versus pro-choice. It is not mainly about death and destruction and it is not about a woman's right to choose. It is only and emphatically about baby design and manufacture, the opening skirmish of what will be a long battle against eugenics and against the post-human future. Once the embryonic clones are produced in laboratories, the eugenic revolution will have begun and we will have lost our best chance to do anything about it and to assume responsible control over where biotechnology is taking us. The present danger posed by human cloning is, paradoxically, also a golden opportunity. The prospect of cloning, so repulsive to contemplate, is the occasion for deciding whether we shall be slaves of unregulated innovation and ultimately its artifacts or whether we shall remain free human beings who guide our medical powers toward the enhancement of human dignity. The humanity of our human future is now in our hands. Thank you.
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[The prepared statement of Dr. Kass follows:]
PREPARED STATEMENT OF LEON R. KASS, M.D., PH.D.(see footnote 1)
Mr. Chairman and Members of the Committee. My name is Leon Kass, and I am the Addie Clark Harding Professor in the Committee on Social Thought and the College at the University of Chicago. Originally trained both as a physician and a biochemist, I have for more than thirty years been professionally concerned with the social and ethical implications of biomedical advance. In fact, my first writing in this area, in 1967, was on the moral dangers of human cloning. I am therefore very grateful for the opportunity to testify before this Committee on the ethics of human cloning and in support of HR 1644, the ''Human Cloning Prohibition Act of 2001.'' And I am profoundly grateful to Rep. Weldon and the many co-sponsors of this bill for their vision in recognizing the momentous choice now before us and for their courage in stepping forward to protect us from what is surely a very great danger to the future of our humanity.
My testimony takes the form of an essay written precisely to gain support for such a bill. It has been published in the May 21, 2001 issue of The New Republic, under the title, ''Preventing a Brave New World: Why We Should Ban Human Cloning Now.'' I begin by calling attention to what is humanly at stake in the decision about human cloning and also to the fact that we have here a golden opportunity to exercise deliberate human command over where biotechnology may be taking us. I argue that we stand now at a major fork in the road, compelled to decide whether we wish to travel down the path to the Brave New World, a path made possible by the genetic control of future generations. I next present four arguments against reproductive cloning of human beings: (1) it constitutes unethical experimentation on the child-to-be; (2) it threatens identity and individuality; (3) it is a giant step toward turning procreation into manufacture (especially when understood as the harbinger of genetic manipulations to come); and (4) it means despotism over children and perversion of parenthood. I conclude by arguing, on multiple grounds, that the only effective way to prevent reproductive cloning is to stop the process at the start, at the stage of creating the embryonic clones, just as is provided for in HR 1644, and I show the weaknesses of the other widely discussed alternative. Once embryonic clones are produced in laboratories, the eugenic revolution will have begun. And we shall have lost our best chance to do anything about it and to assume responsible control over where biotechnology is taking us. I heartily endorse HR 1644 not only because it offers our only real hope of preventing the cloning of human beings, but also because it will give us for the first time some control over those biotechnological powers that threaten to bring about a ''post-human'' future.
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Here is the essay, in full. (I also provide a one-page summary)
PREVENTING A BRAVE NEW WORLD: WHY WE SHOULD BAN HUMAN CLONING NOW
BY LEON R. KASS
The urgency of the great political struggles of the twentieth century, successfully waged against totalitarianisms first right and then left, seems to have blinded many people to a deeper and ultimately darker truth about the present age: all contemporary societies are travelling briskly in the same utopian direction. All are wedded to the modern technological project; all march eagerly to the drums of progress and fly proudly the banner of modern science; all sing loudly the Baconian anthem, ''Conquer nature, relieve man's estate.'' Leading the triumphal procession is modern medicine, which is daily becoming ever more powerful in its battle against disease, decay, and death, thanks especially to astonishing achievements in biomedical science and technologyachievements for which we must surely be grateful.
Yet contemplating present and projected advances in genetic and reproductive technologies, in neuroscience and psychopharmacology, and in the development of artificial organs and computer-chip implants for human brains, we now clearly recognize new uses for biotechnical power that soar beyond the traditional medical goals of healing disease and relieving suffering. Human nature itself lies on the operating table, ready for alteration, for eugenic and psychic ''enhancement,'' for wholesale re-design. In leading laboratories, academic and industrial, new creators are confidently amassing their powers and quietly honing their skills, while on the street their evangelists are zealously prophesying a post-human future. For anyone who cares about preserving our humanity, the time has come to pay attention.
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Some transforming powers are already here. The Pill. In vitro fertilization. Bottled embryos. Surrogate wombs. Cloning. Genetic screening. Genetic manipulation. Organ harvesting. Mechanical spare parts. Chimeras. Brain implants. Ritalin for the young, Viagra for the old, Prozac for everyone. And, to leave this vale of tears, a little extra morphine accompanied by Muzak.
Years ago Aldous Huxley saw it coming. In his charming but disturbing novel, Brave New World (it appeared in 1932 and is more powerful on each re-reading), he made its meaning strikingly visible for all to see. Unlike other frightening futuristic novels of the past century, such as Orwell's already dated Nineteen Eighty-Four, Huxley shows us a dystopia that goes with, rather than against, the human grain. Indeed, it is animated by our own most humane and progressive aspirations. Following those aspirations to their ultimate realization, Huxley enables us to recognize those less obvious but often more pernicious evils that are inextricably linked to the successful attainment of partial goods.
Huxley depicts human life seven centuries hence, living under the gentle hand of humanitarianism rendered fully competent by genetic manipulation, psychoactive drugs, hypnopaedia, and high-tech amusements. At long last, mankind has succeeded in eliminating disease, aggression, war, anxiety, suffering, guilt, envy, and grief. But this victory comes at the heavy price of homogenization, mediocrity, trivial pursuits, shallow attachments, debased tastes, spurious contentment, and souls without loves or longings. The Brave New World has achieved prosperity, community, stability, and nigh-universal contentment, only to be peopled by creatures of human shape but stunted humanity. They consume, fornicate, take ''soma,'' enjoy ''centrifugal bumble-puppy,'' and operate the machinery that makes it all possible. They do not read, write, think, love, or govern themselves. Art and science, virtue and religion, family and friendship are all passe. What matters most is bodily health and immediate gratification: ''Never put off till tomorrow the fun you can have today.'' Brave New Man is so dehumanized that he does not even recognize what has been lost.
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Huxley's novel, of course, is science fiction. Prozac is not yet Huxley's ''soma''; cloning by nuclear transfer or splitting embryos is not exactly ''Bokanovskification''; MTV and virtual-reality parlors are not quite the ''feelies''; and our current safe and consequenceless sexual practices are not universally as loveless or as empty as those in the novel. But the kinships are disquieting, all the more so since our technologies of bio-psycho-engineering are still in their infancy, and in ways that make all too clear what they might look like in their full maturity. Moreover, the cultural changes that technology has already wrought among us should make us even more worried than Huxley would have us be.
In Huxley's novel, everything proceeds under the direction of an omnipotentalbeit benevolentworld state. Yet the dehumanization that he portrays does not really require despotism or external control. To the contrary, precisely because the society of the future will deliver exactly what we most wanthealth, safety, comfort, plenty, pleasure, peace of mind and length of dayswe can reach the same humanly debased condition solely on the basis of free human choice. No need for World Controllers. Just give us the technological imperative, liberal democratic society, compassionate humanitarianism, moral pluralism, and free markets, and we can take ourselves to a Brave New World all by ourselvesand without even deliberately deciding to go. In case you had not noticed, the train has already left the station and is gathering speed, but no one seems to be in charge.
Some among us are delighted, of course, by this state of affairs: some scientists and biotechnologists, their entrepreneurial backers, and a cheering claque of sci-fi enthusiasts, futurologists, and libertarians. There are dreams to be realized, powers to be exercised, honors to be won, and moneybig moneyto be made. But many of us are worried, and not, as the proponents of the revolution self-servingly claim, because we are either ignorant of science or afraid of the unknown. To the contrary, we can see all too clearly where the train is headed, and we do not like the destination. We can distinguish cleverness about means from wisdom about ends, and we are loath to entrust the future of the race to those who cannot tell the difference. No friend of humanity cheers for a post-human future.
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Yet for all our disquiet, we have until now done nothing to prevent it. We hide our heads in the sand because we enjoy the blessings that medicine keeps supplying, or we rationalize our inaction by declaring that human engineering is inevitable and we can do nothing about it. In either case, we are complicit in preparing for our own degradation, in some respects more to blame than the bio-zealots who, however misguided, are putting their money where their mouth is. Denial and despair, unattractive outlooks in any situation, become morally reprehensible when circumstances summon us to keep the world safe for human flourishing. Our immediate ancestors, taking up the challenge of their time, rose to the occasion and rescued the human future from the cruel dehumanizations of Nazi and Soviet tyranny. It is our more difficult task to find ways to preserve it from the soft dehumanizations of well-meaning but hubristic biotechnical ''re-creationism''and to do it without undermining biomedical science or rejecting its genuine contributions to human welfare.
Truth be told, it will not be easy for us to do so, and we know it. But rising to the challenge requires recognizing the difficulties. For there are indeed many features of modern life that will conspire to frustrate efforts aimed at the human control of the biomedical project. First, we Americans believe in technological automatism: where we do not foolishly believe that all innovation is progress, we fatalistically believe that it is inevitable (''If it can be done, it will be done, like it or not''). Second, we believe in freedom: the freedom of scientists to inquire, the freedom of technologists to develop, the freedom of entrepreneurs to invest and to profit, the freedom of private citizens to make use of existing technologies to satisfy any and all personal desires, including the desire to reproduce by whatever means. Third, the biomedical enterprise occupies the moral high ground of compassionate humanitarianism, upholding the supreme values of modern lifecure disease, prolong life, relieve sufferingin competition with which other moral goods rarely stand a chance. (''What the public wants is not to be sick,'' says James Watson, ''and if we help them not to be sick, they'll be on our side.'')
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There are still other obstacles. Our cultural pluralism and easygoing relativism make it difficult to reach consensus on what we should embrace and what we should oppose; and moral objections to this or that biomedical practice are often facilely dismissed as religious or sectarian. Many people are unwilling to pronounce judgments about what is good or bad, right and wrong, even in matters of great importance, even for themselvesnever mind for others or for society as a whole. It does not help that the biomedical project is now deeply entangled with commerce: there are increasingly powerful economic interests in favor of going full steam ahead, and no economic interests in favor of going slow. Since we live in a democracy, moreover, we face political difficulties in gaining a consensus to direct our future, and we have almost no political experience in trying to curtail the development of any new biomedical technology. Finally, and perhaps most troubling, our views of the meaning of our humanity have been so transformed by the scientific-technological approach to the world that we are in danger of forgetting what we have to lose, humanly speaking.
But though the difficulties are real, our situation is far from hopeless. Regarding each of the aforementioned impediments, there is another side to the story. Though we love our gadgets and believe in progress, we have lost our innocence regarding technology. The environmental movement especially has alerted us to the unintended damage caused by unregulated technological advance, and has taught us how certain dangerous practices can be curbed. Though we favor freedom of inquiry, we recognize that experiments are deeds and not speeches, and we prohibit experimentation on human subjects without their consent, even when cures from disease might be had by unfettered research; and we limit so-called reproductive freedom by proscribing incest, polygamy, and the buying and selling of babies.
Page 21 PREV PAGE TOP OF DOC Segment 1 Of 2 Although we esteem medical progress, biomedical institutions have ethics committees that judge research proposals on moral grounds, and, when necessary, uphold the primacy of human freedom and human dignity even over scientific discovery. Our moral pluralism notwithstanding, national commissions and review bodies have sometimes reached moral consensus to recommend limits on permissible scientific research and technological application. On the economic front, the patenting of genes and life forms and the rapid rise of genomic commerce have elicited strong concerns and criticisms, leading even former enthusiasts of the new biology to recoil from the impending commodification of human life. Though we lack political institutions experienced in setting limits on biomedical innovation, federal agencies years ago rejected the development of the plutonium-powered artificial heart, and we have nationally prohibited commercial traffic in organs for transplantation, even though a market would increase the needed supply. In recent years, several American states and many foreign countries have successfully taken political action, making certain practices illegal and placing others under moratoriums (the creation of human embryos solely for research; human germ-line genetic alteration). Most importantly, the majority of Americans are not yet so degraded or so cynical as to fail to be revolted by the society depicted in Huxley's novel. Though the obstacles to effective action are significant, they offer no excuse for resignation. Besides, it would be disgraceful to concede defeat even before we enter the fray.
Not the least of our difficulties in trying to exercise control over where biology is taking us is the fact that we do not get to decide, once and for all, for or against the destination of a post-human world. The scientific discoveries and the technical powers that will take us there come to us piecemeal, one at a time and seemingly independent from one another, each often attractively introduced as a measure that will ''help [us] not to be sick.'' But sometimes we come to a clear fork in the road where decision is possible, and where we know that our decision will make a world of differenceindeed, it will make a permanently different world. Fortunately, we stand now at the point of such a momentous decision. Events have conspired to provide us with a perfect opportunity to seize the initiative and to gain some control of the biotechnical project. I refer to the prospect of human cloning, a practice absolutely central to Huxley's fictional world. Indeed, creating and manipulating life in the laboratory is the gateway to a Brave New World, not only in fiction but also in fact.
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''To clone or not to clone a human being'' is no longer a fanciful question. Success in cloning sheep, and also cows, mice, pigs, and goats, makes it perfectly clear that a fateful decision is now at hand: whether we should welcome or even tolerate the cloning of human beings. If recent newspaper reports are to be believed, reputable scientists and physicians have announced their intention to produce the first human clone in the coming year. Their efforts may already be under way.
The media, gawking and titillating as is their wont, have been softening us up for this possibility by turning the bizarre into the familiar. In the four years since the birth of Dolly the cloned sheep, the tone of discussing the prospect of human cloning has gone from ''Yuck'' to ''Oh?'' to ''Gee whiz'' to ''Why not?'' The sentimentalizers, aided by leading bioethicists, have downplayed talk about eugenically cloning the beautiful and the brawny or the best and the brightest. They have taken instead to defending clonal reproduction for humanitarian or compassionate reasons: to treat infertility in people who are said to ''have no other choice,'' to avoid the risk of severe genetic disease, to ''replace'' a child who has died. For the sake of these rare benefits, they would have us countenance the entire practice of human cloning, the consequences be damned.
But we dare not be complacent about what is at issue, for the stakes are very high. Human cloning, though partly continuous with previous reproductive technologies, is also something radically new in itself and in its easily foreseeable consequencesespecially when coupled with powers for genetic ''enhancement'' and germline genetic modification that may soon become available, owing to the recently completed Human Genome Project. I exaggerate somewhat, but in the direction of the truth: we are compelled to decide nothing less than whether human procreation is going to remain human, whether children are going to be made to order rather than begotten, and whether we wish to say yes in principle to the road that leads to the dehumanized hell of Brave New World.
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Four years ago I addressed this subject in these pages, trying to articulate the moral grounds of our repugnance at the prospect of human cloning (''The Wisdom of Repugnance,'' TNR, June 2, 1997). Subsequent events have only strengthened my conviction that cloning is a bad idea whose time should not come; but my emphasis this time is more practical. To be sure, I would still like to persuade undecided readers that cloning is a serious evil, but I am more interested in encouraging those who oppose human cloning but who think that we are impotent to prevent it, and in mobilizing them to support new and solid legislative efforts to stop it. In addition, I want readers who may worry less about cloning and more about the impending prospects of germline genetic manipulation or other eugenic practices to realize the unique practical opportunity that now presents itself to us.
For we have here a golden opportunity to exercise some control over where biology is taking us. The technology of cloning is discrete and well defined, and it requires considerable technical know-how and dexterity; we can therefore know by name many of the likely practitioners. The public demand for cloning is extremely low, and most people are decidedly against it. Nothing scientifically or medically important would be lost by banning clonal reproduction; alternative and non-objectionable means are available to obtain some of the most important medical benefits claimed for (non-reproductive) human cloning. The commercial interests in human cloning are, for now, quite limited; and the nations of the world are actively seeking to prevent it. Now may be as good a chance as we will ever have to get our hands on the wheel of the runaway train now headed for a post-human world and to steer it toward a more dignified human future.
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What is cloning? Cloning, or asexual reproduction, is the production of individuals who are genetically identical to an already existing individual. The procedure's name is fancy''somatic cell nuclear transfer''but its concept is simple. Take a mature but unfertilized egg; remove or deactivate its nucleus; introduce a nucleus obtained from a specialized (somatic) cell of an adult organism. Once the egg begins to divide, transfer the little embryo to a woman's uterus to initiate a pregnancy. Since almost all the hereditary material of a cell is contained within its nucleus, the re-nucleated egg and the individual into which it develops are genetically identical to the organism that was the source of the transferred nucleus.
An unlimited number of genetically identical individualsthe group, as well as each of its members, is called ''a clone''could be produced by nuclear transfer. In principle, any person, male or female, newborn or adult, could be cloned, and in any quantity; and because stored cells can outlive their sources, one may even clone the dead. Since cloning requires no personal involvement on the part of the person whose genetic material is used, it could easily be used to reproduce living or deceased persons without their consenta threat to reproductive freedom that has received relatively little attention.
Some possible misconceptions need to be avoided. Cloning is not Xeroxing: the clone of Bill Clinton, though his genetic double, would enter the world hairless, toothless, and peeing in his diapers, like any other human infant. But neither is cloning just like natural twinning: the cloned twin will be identical to an older, existing adult; and it will arise not by chance but by deliberate design; and its entire genetic makeup will be pre-selected by its parents and/or scientists. Moreover, the success rate of cloning, at least at first, will probably not be very high: the Scots transferred two hundred seventy-seven adult nuclei into sheep eggs, implanted twenty-nine clonal embryos, and achieved the birth of only one live lamb clone.
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For this reason, among others, it is unlikely that, at least for now, the practice would be very popular; and there is little immediate worry of mass-scale production of multicopies. Still, for the tens of thousands of people who sustain more than three hundred assisted-reproduction clinics in the United States and already avail themselves of in vitro fertilization and other techniques, cloning would be an option with virtually no added fuss. Panos Zavos, the Kentucky reproduction specialist who has announced his plans to clone a child, claims that he has already received thousands of e-mailed requests from people eager to clone, despite the known risks of failure and damaged offspring. Should commercial interests develop in ''nucleus-banking,'' as they have in sperm-banking and egg-harvesting; should famous athletes or other celebrities decide to market their DNA the way they now market their autographs and nearly everything else; should techniques of embryo and germline genetic testing and manipulation arrive as anticipated, increasing the use of laboratory assistance in order to obtain ''better'' babiesshould all this come to pass, cloning, if it is permitted, could become more than a marginal practice simply on the basis of free reproductive choice.
What are we to think about this prospect? Nothing good. Indeed, most people are repelled by nearly all aspects of human cloning: the possibility of mass production of human beings, with large clones of look-alikes, compromised in their individuality; the idea of father-son or mother-daughter ''twins''; the bizarre prospect of a woman bearing and rearing a genetic copy of herself, her spouse, or even her deceased father or mother; the grotesqueness of conceiving a child as an exact ''replacement'' for another who has died; the utilitarian creation of embryonic duplicates of oneself, to be frozen away or created when needed to provide homologous tissues or organs for transplantation; the narcissism of those who would clone themselves, and the arrogance of others who think they know who deserves to be cloned; the Frankensteinian hubris to create a human life and increasingly to control its destiny; men playing at being God. Almost no one finds any of the suggested reasons for human cloning compelling, and almost everyone anticipates its possible misuses and abuses. And the popular belief that human cloning cannot be prevented makes the prospect all the more revolting.
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Revulsion is not an argument; and some of yesterday's repugnances are today calmly acceptednot always for the better. In some crucial cases, however, repugnance is the emotional expression of deep wisdom, beyond reason's power completely to articulate it. Can anyone really give an argument fully adequate to the horror that is father-daughter incest (even with consent), or bestiality, or the mutilation of a corpse, or the eating of human flesh, or the rape or murder of another human being? Would anybody's failure to give full rational justification for his revulsion at those practices make that revulsion ethically suspect?
I suggest that our repugnance at human cloning belongs in this category. We are repelled by the prospect of cloning human beings not because of the strangeness or the novelty of the undertaking, but because we intuit and we feel, immediately and without argument, the violation of things that we rightfully hold dear. We sense that cloning represents a profound defilement of our given nature as procreative beings, and of the social relations built on this natural ground. We also sense that cloning is a radical form of child abuse. In this age in which everything is held to be permissible so long as it is freely done, and in which our bodies are regarded as mere instruments of our autonomous rational will, repugnance may be the only voice left that speaks up to defend the central core of our humanity. Shallow are the souls that have forgotten how to shudder.
Yet repugnance need not stand naked before the bar of reason. The wisdom of our horror at human cloning can be at least partially articulated, even if this is finally one of those instances about which the heart has its reasons that reason cannot entirely know. I offer four objections to human cloning: that it constitutes unethical experimentation; that it threatens identity and individuality; that it turns procreation into manufacture (especially when understood as the harbinger of manipulations to come); and that it means despotism over children and perversion of parenthood. Please note: I speak only about so-called reproductive cloning, not about the creation of cloned embryos for research. The objections that may be raised against creating (or using) embryos for research are entirely independent of whether the research embryos are produced by cloning. What is radically distinct and radically new is reproductive cloning.
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Any attempt to clone a human being would constitute an unethical experiment upon the resulting child-to-be. In all the animal experiments, fewer than two to three percent of all cloning attempts succeeded. Not only are there fetal deaths and stillborn infants, but many of the so-called ''successes'' are in fact failures. As has only recently become clear, there is a very high incidence of major disabilities and deformities in cloned animals that attain live birth. Cloned cows often have heart and lung problems; cloned mice later develop pathological obesity; other live-born cloned animals fail to reach normal developmental milestones.
The problem, scientists suggest, may lie in the fact that an egg with a new somatic nucleus must re-program itself in a matter of minutes or hours (whereas the nucleus of an unaltered egg has been prepared over months and years). There is thus a greatly increased likelihood of error in translating the genetic instructions, leading to developmental defects some of which will show themselves only much later. (Note also that these induced abnormalities may also affect the stem cells that scientists hope to harvest from cloned embryos. Lousy embryos, lousy stem cells.) Nearly all scientists now agree that attempts to clone human beings carry massive risks of producing unhealthy, abnormal, and malformed children. What are we to do with them? Shall we just discard the ones that fall short of expectations? Considered opinion is today nearly unanimous, even among scientists: attempts at human cloning are irresponsible and unethical. We cannot ethically even get to know whether or not human cloning is feasible.
If it were successful, cloning would create serious issues of identity and individuality. The clone may experience concerns about his distinctive identity not only because he will be, in genotype and in appearance, identical to another human being, but because he may also be twin to the person who is his ''father'' or his ''mother''if one can still call them that. Unaccountably, people treat as innocent the homey case of intra-familial cloningthe cloning of husband or wife (or single mother). They forget about the unique dangers of mixing the twin relation with the parent-child relation. (For this situation, the relation of contemporaneous twins is no precedent; yet even this less problematic situation teaches us how difficult it is to wrest independence from the being for whom one has the most powerful affinity.) Virtually no parent is going to be able to treat a clone of himself or herself as one treats a child generated by the lottery of sex. What will happen when the adolescent clone of Mommy becomes the spitting image of the woman with whom Daddy once fell in love? In case of divorce, will Mommy still love the clone of Daddy, even though she can no longer stand the sight of Daddy himself?
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Most people think about cloning from the point of view of adults choosing to clone. Almost nobody thinks about what it would be like to be the cloned child. Surely his or her new life would constantly be scrutinized in relation to that of the older version. Even in the absence of unusual parental expectations for the clonesay, to live the same life, only without its errorsthe child is likely to be ever a curiosity, ever a potential source of déjà vu. Unlike ''normal'' identical twins, a cloned individualcopied from whomeverwill be saddled with a genotype that has already lived. He will not be fully a surprise to the world: people are likely always to compare his doings in life with those of his alter ego, especially if he is a clone of someone gifted or famous. True, his nurture and his circumstance will be different; genotype is not exactly destiny. But one must also expect parental efforts to shape this new life after the originalor at least to view the child with the original version always firmly in mind. For why else did they clone from the star basketball player, the mathematician, or the beauty queenor even dear old Dadin the first place?
Human cloning would also represent a giant step toward the transformation of begetting into making, of procreation into manufacture (literally, ''handmade''), a process that has already begun with in vitro fertilization and genetic testing of embryos. With cloning, not only is the process in hand, but the total genetic blueprint of the cloned individual is selected and determined by the human artisans. To be sure, subsequent development is still according to natural processes; and the resulting children will be recognizably human. But we would be taking a major step into making man himself simply another one of the man-made things.
How does begetting differ from making? In natural procreation, human beings come together to give existence to another being that is formed exactly as we were, by what we areliving, hence perishable, hence aspiringly erotic, hence procreative human beings. But in clonal reproduction, and in the more advanced forms of manufacture to which it will lead, we give existence to a being not by what we are but by what we intend and design.
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Let me be clear. The problem is not the mere intervention of technique, and the point is not that ''nature knows best.'' The problem is that any child whose being, character, and capacities exist owing to human design does not stand on the same plane as its makers. As with any product of our making, no matter how excellent, the artificer stands above it, not as an equal but as a superior, transcending it by his will and creative prowess. In human cloning, scientists and prospective ''parents'' adopt a technocratic attitude toward human children: human children become their artifacts. Such an arrangement is profoundly dehumanizing, no matter how good the product.
Procreation dehumanized into manufacture is further degraded by commodification, a virtually inescapable result of allowing baby-making to proceed under the banner of commerce. Genetic and reproductive biotechnology companies are already growth industries, but they will soon go into commercial orbit now that the Human Genome Project has been completed. ''Human eggs for sale'' is already a big business, masquerading under the pretense of ''donation.'' Newspaper advertisements on elite college campuses offer up to $50,000 for an egg ''donor'' tall enough to play women's basketball and with SAT scores high enough for admission to Stanford; and to nobody's surprise, at such prices there are many young coeds eager to help shoppers obtain the finest babies money can buy. (The egg and womb-renting entrepreneurs shamelessly proceed on the ancient, disgusting, misogynist premise that most women will give you access to their bodies, if the price is right.) Even before the capacity for human cloning is perfected, established companies will have invested in the harvesting of eggs from ovaries obtained at autopsy or through ovarian surgery, practiced embryonic genetic alteration, and initiated the stockpiling of prospective donor tissues. Through the rental of surrogate-womb services, and through the buying and selling of tissues and embryos priced according to the merit of the donor, the commodification of nascent human life will be unstoppable.
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Finally, the practice of human cloning by nuclear transferlike other anticipated forms of genetically engineering the next generationwould enshrine and aggravate a profound misunderstanding of the meaning of having children and of the parent-child relationship. When a couple normally chooses to procreate, the partners are saying yes to the emergence of new life in its noveltyare saying yes not only to having a child, but also to having whatever child this child turns out to be. In accepting our finitude, in opening ourselves to our replacement, we tacitly confess the limits of our control.
Embracing the future by procreating means precisely that we are relinquishing our grip in the very activity of taking up our own share in what we hope will be the immortality of human life and the human species. This means that our children are not our children: they are not our property, they are not our possessions. Neither are they supposed to live our lives for us, or to live anyone's life but their own. Their genetic distinctiveness and independence are the natural foreshadowing of the deep truth that they have their own, never-before-enacted life to live. Though sprung from a past, they take an uncharted course into the future.
Much mischief is already done by parents who try to live vicariously through their children. Children are sometimes compelled to fulfill the broken dreams of unhappy parents. But whereas most parents normally have hopes for their children, cloning parents will have expectations. In cloning, such overbearing parents will have taken at the start a decisive step that contradicts the entire meaning of the open and forward-looking nature of parent-child relations. The child is given a genotype that has already lived, with full expectation that this blueprint of a past life ought to be controlling the life that is to come. A wanted child now means a child who exists precisely to fulfill parental wants. Like all the more precise eugenic manipulations that will follow in its wake, cloning is thus inherently despotic, for it seeks to make one's children after one's own image (or an image of one's choosing) and their future according to one's will.
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Is this hyperbolic? Consider concretely the new realities of responsibility and guilt in the households of the cloned. No longer only the sins of the parents, but also the genetic choices of the parents, will be visited on the childrenand beyond the third and fourth generation; and everyone will know who is responsible. No parent will be able to blame nature or the lottery of sex for an unhappy adolescent's big nose, dull wit, musical ineptitude, nervous disposition, or anything else that he hates about himself. Fairly or not, children will hold their cloners responsible for everything, for nature as well as for nurture. And parents, especially the better ones, will be limitlessly liable to guilt. Only the truly despotic souls will sleep the sleep of the innocent.
The defenders of cloning are not wittingly friends of despotism. Quite the contrary. Deaf to most other considerations, they regard themselves mainly as friends of freedom: the freedom of individuals to reproduce, the freedom of scientists and inventors to discover and to devise and to foster ''progress'' in genetic knowledge and technique, the freedom of entrepreneurs to profit in the market. They want large-scale cloning only for animals, but they wish to preserve cloning as a human option for exercising our ''right to reproduce''our right to have children, and children with ''desirable genes.'' As some point out, under our ''right to reproduce'' we already practice early forms of unnatural, artificial, and extra-marital reproduction, and we already practice early forms of eugenic choice. For that reason, they argue, cloning is no big deal.
We have here a perfect example of the logic of the slippery slope. The principle of reproductive freedom currently enunciated by the proponents of cloning logically embraces the ethical acceptability of sliding all the way down: to producing children wholly in the laboratory from sperm to term (should it become feasible), and to producing children whose entire genetic makeup will be the product of parental eugenic planning and choice. If reproductive freedom means the right to have a child of one's own choosing by whatever means, then reproductive freedom knows and accepts no limits.
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Proponents want us to believe that there are legitimate uses of cloning that can be distinguished from illegitimate uses, but by their own principles no such limits can be found. (Nor could any such limits be enforced in practice: once cloning is permitted, no one ever need discover whom one is cloning and why.) Reproductive freedom, as they understand it, is governed solely by the subjective wishes of the parents-to-be. The sentimentally appealing case of the childless married couple is, on these grounds, indistinguishable from the case of an individual (married or not) who would like to clone someone famous or talented, living or dead. And the principle here endorsed justifies not only cloning but also all future artificial attempts to create (manufacture) ''better'' or ''perfect'' babies.
The ''perfect baby,'' of course, is the project not of the infertility doctors, but of the eugenic scientists and their supporters, who, for the time being, are content to hide behind the skirts of the partisans of reproductive freedom and compassion for the infertile. For them, the paramount right is not the so-called right to reproduce, it is what the biologist Bentley Glass called, a quarter of a century ago, ''the right of every child to be born with a sound physical and mental constitution, based on a sound genotype . . . the inalienable right to a sound heritage.'' But to secure this right, and to achieve the requisite quality control over new human life, human conception and gestation will need to be brought fully into the bright light of the laboratory, beneath which the child-to-be can be fertilized, nourished, pruned, weeded, watched, inspected, prodded, pinched, cajoled, injected, tested, rated, graded, approved, stamped, wrapped, sealed, and delivered. There is no other way to produce the perfect baby.
If you think that such scenarios require outside coercion or governmental tyranny, you are mistaken. Once it becomes possible, with the aid of human genomics, to produce or to select for what some regard as ''better babies''smarter, prettier, healthier, more athleticparents will leap at the opportunity to ''improve'' their offspring. Indeed, not to do so will be socially regarded as a form of child neglect. Those who would ordinarily be opposed to such tinkering will be under enormous pressure to compete on behalf of their as yet unborn childrenjust as some now plan almost from their children's birth how to get them into Harvard. Never mind that, lacking a standard of ''good'' or ''better,'' no one can really know whether any such changes will truly be improvements.
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Proponents of cloning urge us to forget about the science-fiction scenarios of laboratory manufacture or multiple-copy clones, and to focus only on the sympathetic cases of infertile couples exercising their reproductive rights. But why, if the single cases are so innocent, should multiplying their performance be so off-putting? (Similarly, why do others object to people's making money from that practice if the practice itself is perfectly acceptable?) The so-called science-fiction casessay, Brave New Worldmake vivid the meaning of what looks to us, mistakenly, to be benign. They reveal that what looks like compassionate humanitarianism is, in the end, crushing dehumanization.
Whether or not they share my reasons, most people, I think, share my conclusion: that human cloning is unethical in itself and dangerous in its likely consequences, which include the precedent that it will establish for designing our children. Some reach this conclusion for their own good reasons, different from my own: concerns about distributive justice in access to eugenic cloning; worries about the genetic effects of asexual ''inbreeding''; aversion to the implicit premise of genetic determinism; objections to the embryonic and fetal wastage that must necessarily accompany the efforts; religious opposition to ''man playing God.'' But never mind why: the overwhelming majority of our fellow Americans remain firmly opposed to cloning human beings.
For us, then, the real questions are: What should we do about it? How can we best succeed? These questions should concern everyone eager to secure deliberate human control over the powers that could re-design our humanity, even if cloning is not the issue over which they would choose to make their stand. And the answer to the first question seems pretty plain. What we should do is work to prevent human cloning by making it illegal.
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We should aim for a global legal ban, if possible, and for a unilateral national ban at a minimumand soon, before the fact is upon us. To be sure, legal bans can be violated; but we certainly curtail much mischief by outlawing incest, voluntary servitude, and the buying and selling of organs and babies. To be sure, renegade scientists may secretly undertake to violate such a law, but we can deter them by both criminal sanctions and monetary penalties, as well as by removing any incentive they have to proudly claim credit for their technological bravado.
Such a ban on clonal baby-making will not harm the progress of basic genetic science and technology. On the contrary, it will reassure the public that scientists are happy to proceed without violating the deep ethical norms and intuitions of the human community. It will also protect honorable scientists from a public backlash against the brazen misconduct of the rogues. As many scientists have publicly confessed, free and worthy science probably has much more to fear from a strong public reaction to a cloning fiasco than it does from a cloning ban, provided that the ban is judiciously crafted and vigorously enforced against those who would violate it.
Five statesMichigan, Louisiana, California, Rhode Island, and Virginiahave already enacted a ban on human cloning, and several others are likely to follow suit this year. Michigan, for example, has made it a felony, punishable by imprisonment for not more than ten years or a fine of not more than $10 million, or both, to ''intentionally engage in or attempt to engage in human cloning,'' where human cloning means ''the use of human somatic cell nuclear transfer technology to produce a human embryo.'' Internationally, the movement to ban human cloning gains momentum. France and Germany have banned cloning (and germline genetic engineering), and the Council of Europe is working to have it banned in all of its forty-one member countries, and Canada is expected to follow suit. The United Nations, UNESCO, and the Group of Seven have called for a global ban on human cloning.
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Given the decisive actions of the rest of the industrialized world, the United States looks to some observers to be a rogue nation. A few years ago, soon after the birth of Dolly, President Clinton called for legislation to outlaw human cloning, and attempts were made to produce a national ban. Yet none was enacted, despite general agreement in Congress that it would be desirable to have such a ban. One might have thought that it would be easy enough to find clear statutory language for prohibiting attempts to clone a human being (and other nations have apparently not found it difficult). But, alas, in the last national go-around, there was trouble over the apparently vague term ''human being,'' and whether it includes the early (pre-implantation) embryonic stages of human life. Learning from this past failure, we can do better this time around. Besides, circumstances have changed greatly in the intervening three years, making a ban both more urgent and less problematic.
Two major anti-cloning bills were introduced into the Senate in 1998. The Democratic bill (Kennedy-Feinstein) would have banned so-called reproductive cloning by prohibiting transfer of cloned embryos into women to initiate pregnancy. The Republican bill (Frist-Bond) would have banned all cloning by prohibiting the creation even of embryonic human clones. Both sides opposed ''reproductive cloning,'' the attempt to bring to birth a living human child who is the clone of someone now (or previously) alive. But the Democratic bill sanctioned creating cloned embryos for research purposes, and the Republican bill did not. The pro-life movement could not support the former, whereas the scientific community and the biotechnology industry opposed the latter; indeed, they successfully lobbied a dozen Republican senators to oppose taking a vote on the Republican bill (which even its supporters now admit was badly drafted). Owing to a deep and unbridgeable gulf over the question of embryo research, we did not get the congressional ban on reproductive cloning that nearly everyone wanted. It would be tragic if we again failed to produce a ban on human cloning because of its seemingly unavoidable entanglement with the more divisive issue of embryo research.
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To find a way around this impasse, several people (myself included) advocated a legislative ''third way,'' one that firmly banned only reproductive cloning but did not legitimate creating cloned embryos for research. This, it turns out, is hard to do. It is easy enough to state the necessary negative disclaimer that would set aside the embryo-research question: ''Nothing in this act shall be taken to determine the legality of creating cloned embryos for research; this act neither permits nor prohibits such activity.'' It is much more difficult to state the positive prohibition in terms that are unambiguous and acceptable to all sides. To indicate only one difficulty: indifference to the creation of embryonic clones coupled with a ban (only) on their transfer would place the federal government in the position of demanding the destruction of nascent life, a bitter pill to swallow even for pro-choice advocates.
Given both these difficulties, and given the imminence of attempts at human cloning, I now believe that what we need is an all-out ban on human cloning, including the creation of embryonic clones. I am convinced that all halfway measures will prove to be morally, legally, and strategically flawed, andmost importantthat they will not be effective in obtaining the desired result. Anyone truly serious about preventing human reproductive cloning must seek to stop the process from the beginning. Our changed circumstances, and the now evident defects of the less restrictive alternatives, make an all-out ban by far the most attractive and effective option.
Here's why. Creating cloned human children (''reproductive cloning'') necessarily begins by producing cloned human embryos. Preventing the latter would prevent the former, and prudence alone might counsel building such a ''fence around the law.'' Yet some scientists favor embryo cloning as a way of obtaining embryos for research or as sources of cells and tissues for the possible benefit of others. (This practice they misleadingly call ''therapeutic cloning'' rather than the more accurate ''cloning for research'' or ''experimental cloning,'' so as to obscure the fact that the clone will be ''treated'' only to exploitation and destruction, and that any potential future beneficiaries and any future ''therapies'' are at this point purely hypothetical.)
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The prospect of creating new human life solely to be exploited in this way has been condemned on moral grounds by many peopleincluding The Washington Post, President Clinton, and many other supporters of a woman's right to abortionas displaying a profound disrespect for life. Even those who are willing to scavenge so-called ''spare embryos''those products of in vitro fertilization made in excess of people's reproductive needs, and otherwise likely to be discardeddraw back from creating human embryos explicitly and solely for research purposes. They reject outright what they regard as the exploitation and the instrumentalization of nascent human life. In addition, others who are agnostic about the moral status of the embryo see the wisdom of not needlessly offending the sensibilities of their fellow citizens who are opposed to such practices.
But even setting aside these obvious moral first impressions, a few moments of reflection show why an anti-cloning law that permitted the cloning of embryos but criminalized their transfer to produce a child would be a moral blunder. This would be a law that was not merely permissively ''pro-choice'' but emphatically and prescriptively ''anti-life.'' While permitting the creation of an embryonic life, it would make it a federal offense to try to keep it alive and bring it to birth. Whatever one thinks of the moral status or the ontological status of the human embryo, moral sense and practical wisdom recoil from having the government of the United States on record as requiring the destruction of nascent life and, what is worse, demanding the punishment of those who would act to preserve it by (feloniously!) giving it birth.
But the problem with the approach that targets only reproductive cloning (that is, the transfer of the embryo to a woman's uterus) is not only moral but also legal and strategic. A ban only on reproductive cloning would turn out to be unenforceable. Once cloned embryos were produced and available in laboratories and assisted-reproduction centers, it would be virtually impossible to control what was done with them. Biotechnical experiments take place in laboratories, hidden from public view, and, given the rise of high-stakes commerce in biotechnology, these experiments are concealed from the competition. Huge stockpiles of cloned human embryos could thus be produced and bought and sold without anyone knowing it. As we have seen with in vitro embryos created to treat infertility, embryos produced for one reason can be used for another reason: today ''spare embryos'' once created to begin a pregnancy are now used in research, and tomorrow clones created for research will be used to begin a pregnancy.
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Assisted reproduction takes place within the privacy of the doctor-patient relationship, making outside scrutiny extremely difficult. Many infertility experts probably would obey the law, but others could and would defy it with impunity, their doings covered by the veil of secrecy that is the principle of medical confidentiality. Moreover, the transfer of embryos to begin a pregnancy is a simple procedure (especially compared with manufacturing the embryo in the first place), simple enough that its final steps could be self-administered by the woman, who would thus absolve the doctor of blame for having ''caused'' the illegal transfer. (I have in mind something analogous to Kevorkian's suicide machine, which was designed to enable the patient to push the plunger and the good ''doctor'' to evade criminal liability.)
Even should the deed become known, governmental attempts to enforce the reproductive ban would run into a swarm of moral and legal challenges, both to efforts aimed at preventing transfer to a woman andeven worseto efforts seeking to prevent birth after transfer has occurred. A woman who wished to receive the embryo clone would no doubt seek a judicial restraining order, suing to have the law overturned in the name of a constitutionally protected interest in her own reproductive choice to clone. (The cloned child would be born before the legal proceedings were complete.) And should an ''illicit clonal pregnancy'' be discovered, no governmental agency would compel a woman to abort the clone, and there would be an understandable storm of protest should she be fined or jailed after she gives birth. Once the baby is born, there would even be sentimental opposition to punishing the doctor for violating the lawunless, of course, the clone turned out to be severely abnormal.
For all these reasons, the only practically effective and legally sound approach is to block human cloning at the start, at the production of the embryo clone. Such a ban can be rightly characterized not as interference with reproductive freedom, nor even as interference with scientific inquiry, but as an attempt to prevent the unhealthy, unsavory, and unwelcome manufacture of and traffic in human clones.
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Some scientists, pharmaceutical companies, and bio-entrepreneurs may balk at such a comprehensive restriction. They want to get their hands on those embryos, especially for their stem cells, those pluripotent cells that can in principle be turned into any cells and any tissues in the body, potentially useful for transplantation to repair somatic damage. Embryonic stem cells need not come from cloned embryos, of course; but the scientists say that stem cells obtained from clones could be therapeutically injected into the embryo's adult ''twin'' without any risk of immunological rejection. It is the promise of rejection-free tissues for transplantation that so far has been the most successful argument in favor of experimental cloning. Yet new discoveries have shown that we can probably obtain the same benefits without embryo cloning. The facts are much different than they were three years ago, and the weight in the debate about cloning for research should shift to reflect the facts.
Numerous recent studies have shown that it is possible to obtain highly potent stem cells from the bodies of children and adultsfrom the blood, bone marrow, brain, pancreas, and, most recently, fat. Beyond all expectations, these non-embryonic stem cells have been shown to have the capacity to turn into a wide variety of specialized cells and tissues. (At the same time, early human therapeutic efforts with stem cells derived from embryos have produced some horrible results, the cells going wild in their new hosts and producing other tissues in addition to those in need of replacement. If an in vitro embryo is undetectably abnormalas so often they arethe cells derived from it may also be abnormal.) Since cells derived from our own bodies are more easily and cheaply available than cells harvested from specially manufactured clones, we will almost surely be able to obtain from ourselves any needed homologous transplantable cells and tissues, without the need for egg donors or cloned embryonic copies of ourselves. By pouring our resources into adult stem cell research (or, more accurately, ''non-embryonic'' stem cell research), we can also avoid the morally and legally vexing issues in embryo research. And more to our present subject, by eschewing the cloning of embryos, we make the cloning of human beings much less likely.
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A few weeks ago an excellent federal anti-cloning bill was introduced in Congress, sponsored by Senator Sam Brownback and Representative David Weldon. This carefully drafted legislation seeks to prevent the cloning of human beings at the very first step, by prohibiting somatic cell nuclear transfer to produce embryonic clones, and provides substantial criminal and monetary penalties for violating the law. The bill makes very clear that there is to be no interference with the scientific and medically useful practices of cloning DNA fragments (molecular cloning), with the duplication of somatic cells (or stem cells) in tissue culture (cell cloning), or with whole-organism or embryo cloning of non-human animals. If enacted, this law would bring the United States into line with the current or soon-to-be-enacted practices of many other nations. Most important, it offers us the best chancethe only realistic chancethat we have to keep human cloning from happening, or from happening much.
Getting this bill passed will not be easy. The pharmaceutical and biotech companies and some scientific and patient-advocacy associations may claim that the bill is the work of bio-Luddites: anti-science, a threat to free inquiry, an obstacle to obtaining urgently needed therapies for disease. Some feminists and pro-choice groups will claim that this legislation is really only a sneaky device for fighting Roe v. Wade, and they will resist anything that might be taken even to hint that a human embryo has any moral worth. On the other side, some right-to-life purists, who care not how babies are made as long as life will not be destroyed, will withhold their support because the bill does not take a position against embryo twinning or embryo research in general.
All of these arguments are wrong, and all of them must be resisted. This is not an issue of pro-life versus pro-choice. It is not about death and destruction, or about a woman's right to choose. It is only and emphatically about baby design and manufacture: the opening skirmish of a long battle against eugenics and against a post-human future. As such, it is an issue that should not divide ''the left'' and ''the right''; and there are people across the political spectrum who are coalescing in the efforts to stop human cloning. (The prime sponsor of Michigan's comprehensive anti-cloning law is a pro-choice Democratic legislator.) Everyone needs to understand that, whatever we may think about the moral status of embryos, once embryonic clones are produced in the laboratories the eugenic revolution will have begun. And we shall have lost our best chance to do anything about it.
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As we argue in the coming weeks about this legislation, let us be clear about the urgency of our situation and the meaning of our action or inaction. Scientists and doctors whose names we know, and probably many others whose names we do not know, are today working to clone human beings. They are aware of the immediate hazards, but they are undeterred. They are prepared to screen and to destroy anything that looks abnormal. They do not care that they will not be able to detect most of the possible defects. So confident are they in their rectitude that they are willing to ignore all future consequences of the power to clone human beings. They are prepared to gamble with the well-being of any live-born clones, and, if I am right, with a great deal more, all for the glory of being the first to replicate a human being. They are, in short, daring the community to defy them. In these circumstances, our silence can only mean acquiescence. To do nothing now is to accept the responsibility for the deed and for all that follows predictably in its wake.
I appreciate that a federal legislative ban on human cloning is without American precedent, at least in matters technological. Perhaps such a ban will prove ineffective; perhaps it will eventually be shown to have been a mistake. (If so, it could later be reversed.) If enacted, however, it will have achieved one overwhelmingly important result, in addition to its contribution to thwarting cloning: it will place the burden of practical proof where it belongs. It will require the proponents to show very clearly what great social or medical good can be had only by the cloning of human beings. Surely it is only for such a compelling case, yet to be made or even imagined, that we should wish to risk this major departureor any other major departurein human procreation.
Americans have lived by and prospered under a rosy optimism about scientific and technological progress. The technological imperative has probably served us well, though we should admit that there is no accurate method for weighing benefits and harms. And even when we recognize the unwelcome outcomes of technological advance, we remain confident in our ability to fix all the ''bad'' consequencesby regulation or by means of still newer and better technologies. Yet there is very good reason for shifting the American paradigm, at least regarding those technological interventions into the human body and mind that would surely effect fundamental (and likely irreversible) changes in human nature, basic human relationships, and what it means to be a human being. Here we should not be willing to risk everything in the naive hope that, should things go wrong, we can later set them right again.
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Some have argued that cloning is almost certainly going to remain a marginal practice, and that we should therefore permit people to practice it. Such a view is shortsighted. Even if cloning is rarely undertaken, a society in which it is tolerated is no longer the same societyany more than is a society that permits (even small-scale) incest or cannibalism or slavery. A society that allows cloning, whether it knows it or not, has tacitly assented to the conversion of procreation into manufacture and to the treatment of children as purely the projects of our will. Willy-nilly, it has acquiesced in the eugenic re-design of future generations. The humanitarian superhighway to a Brave New World lies open before this society.
But the present danger posed by human cloning is, paradoxically, also a golden opportunity. In a truly unprecedented way, we can strike a blow for the human control of the technological project, for wisdom, for prudence, for human dignity. The prospect of human cloning, so repulsive to contemplate, is the occasion for deciding whether we shall be slaves of unregulated innovation, and ultimately its artifacts, or whether we shall remain free human beings who guide our powers toward the enhancement of human dignity. The humanity of the human future is now in our hands.
New biomedical technologies are rapidly providing powers to intervene in human bodies and minds in ways that threaten fundamental changes in human nature and the meaning of our humanity. We now stand at a major fork at the road, compelled to decide whether we wish to travel down the path to the Brave New World: we must decide whether to tolerate the practice of human cloning, the asexual reproduction of human beings, made as genetic copies of already (or previously) existing individuals. Reputable scientists have announced plans to clone human beings in the coming year and are daring us to stop them. Our failure to try to do so constitutes our tacit acquiescence.
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The vast majority of Americans object to human cloning, and on multiple moral grounds. It constitutes unethical experimentation on the child-to-be. It threatens identity and individuality. It represents a giant step toward turning procreation into manufacture, legitimizing in advance the eugenic redesigning of our children. And it is a radical form of parental despotism and child abuse. Permitting human cloning means saying yes to the dangerous principle that we are entitled to determine the genetic make-up of our children. If we do not wish to travel down this eugenic road, an effective ban on cloning human beings is needed, and needed now before we are overtaken by events.
Two legislative alternatives have been proposed: one would ban only so-called reproductive cloning by prohibiting the transfer of a cloned embryo to a woman to initiate a pregnancy; the other would ban all cloning by prohibiting the creation even of the embryonic human clones. Arguments are given why the latter proposal is much to be preferred. Once cloned embryos are produced and available in laboratories and assisted-reproduction centers, it will be virtually impossible to control what is done with them. Stockpiles of cloned human embryos could be produced and bought and sold without anyone knowing it. Efforts at clonal reproduction would take place out of sight, within the privacy of the doctor-patient relationship. Moreover, a ban on only reproductive cloning will turn out to be unenforceable. Should ''illicit cloning'' be discovered, governmental attempts to enforce the reproductive ban would run into a swarm of legal and practical challenges, and the practice will prove impossible to police or regulate. Anyone truly serious about preventing human reproductive cloning must seek to stop the process from the beginning.
This is not an issue of pro-life vs. pro-choice. It is not about death and destruction or about a woman's right to choose. It is only and emphatically an issue of baby-design and manufacture, the opening skirmish of a long battle against eugenics and against a ''post-human'' future. Once embryonic clones are produced in laboratories, the eugenic revolution will have begun. And we shall have lost our best chance to do anything about it and to assume responsible control over where biotechnology is taking us. The humanity of the human future is now in our hands.
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Mr. SMITH. Thank you, Dr. Kass. Dr. Callahan.
STATEMENT OF DANIEL CALLAHAN, DIRECTOR OF INTERNATIONAL PROGRAMS, HASTING CENTER, GARRISON, NY
Mr. CALLAHAN. Thank you, Mr. Chairman. I want to talk about two things today. First, I would like to say a little bit about my opposition, ethically, to cloning, but then I would like to deal with the question of whether it would be ethically appropriate to ban scientific research on cloning. I want to argue that there are obvious legal issues involved in the scientific ban, but it seems to me that there is a fundamental ethical question of whether that is a way to go in the first place.
Let me very briefly sum up my general objection to cloning. I come down to one point most decisively; that is, I see a profound threat to the individuality of children so born. I think it is part of our human nature, part of what we consider our fundamental individuality and identity, that we're different from other people. Surely it is the case, as many have pointed out, that a cloned person would not be genetically absolutely identical, and because of environmental forces, it is also the case at the person would not even be psychologically identical, but as we know from twin studies, approximately 50 percent of personal traits are shared by identical twins. More importantly, even if a clone is not going to be totally identical, it would be identical enough that there would be a fundamental threat to what is distinctive about ourself, which is partly our appearance, partly the fact that there is no one on earth quite like us. I begin with that basic point.
Page 45 PREV PAGE TOP OF DOC Segment 1 Of 2 On the question of the relationship of law and ethics, which is obviously a major problem in American society, and always has been, the question of what moral principles do we want to enact into law, which ones do we want to leave free of the law, subject to stigmatization, personal pressure, political forces and the like, is an issue long debated. I believe in this case that a ban would be appropriate and justifiable. The main justification needed for a ban is that there is a fundamental threat to important social and public values, and in this case I believe there is such a threat.
The question, though, is still, given the important precedent that would be set by banning research at this fundamental level, whether the very powerful burden of argument in favor of itagainst itcan be discharged. I think that the bias in our society, an appropriate bias, is that anyone who would want to ban scientific research has a very difficult burden to discharge. I believe in this case that the burden can be discharged. First of all, the simple fact that we would be changing the nature of procreation and parenthood in a radical way is, itself, a very strong argument, but I think we can anticipate that scientists would feel this is a fundamental threat to their liberty and to an important part of the American and scientific tradition.
A fundamental response to this argument can be made. First of all, we certainly have restricted science in many ways in our society. We have a requirement with human subject research that people give informed consent before being used as subjects, and we simply do not allow practical or utilitarian considerations to overturn that very firm ban. We have certainly regulated science in many ways, and, it seems to me, by enacting a ban here, we will not be doing something fundamentally different, but granted we are taking one further step. I think the fundamental reason for a ban, part of which has been really developed by Dr. Kass, is that if we do not have a ban at the very fundamental research level with the techniques for human cloning, the ability to really control in the long run will not be possible.
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I am struck by the fact that too much of our current interest in biomedical research is, seems to me, fueled by a kind of single-minded passion to eliminate disease, often likened to a war, in fact, we use the language of a war against disease very often. I think the worst possible analogy of biomedical research is that of warfare. Illness, death and suffering are terrible human threats, but to approach them as if nothing less than all out battle with no holds barred will demonstrate our moral seriousness is a profound mistake. Health is a great and vital human good, but not the only such good.
The point of a ban on research for human cloning is to make certain that some time-tested critical means of human procreation and human individuality are protected. They are an as important part of our Western American heritage as freedom of scientific inquiry, the freedom that has well co-existed for some years with ethical limitations and has managed to flourish is the face of and sometimes because of those limitations. In short, I do not think that a ban would in any way fundamentally be a threat to the future of scientific research here. I believe there are alternatives to the proposed lines of research which ought to be explored, and in any case, it seems to me, that the very basic necessity to protect our children and children in the future and to protect our very fundamental commitment to a procreation that generates individual, unique people is something that ought not to be in anyway overcome. Thank you.
[The prepared statement of Mr. Callahan follows:]
PREPARED STATEMENT OF DANIEL CALLAHAN
I am Daniel Callahan, Director of the International Program of The Hastings Center, Garrison, N.Y., a research center devoted to biomedical and environmental ethics. I pleased to take part in this hearing. It focuses on a topic of great important for the human future and the proper use of scientific research as it moves toward that future. Research on human cloning would chart not only a new direction for biomedical research but also, in its implications, a new direction for the procreation of human life.
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I oppose such research, for reasons I will shortly present, but the main purpose of my testimony will be to discuss proposals to ban such research, at both the federal and the private levels. I want to combine the topics of the ethics of human cloning and the ethics of controlling the research for one simple reason: if research on human cloning is a bad direction in which to go, what can be done about that? What is the appropriate connection, with the issue of human cloning, between ethics and the law? The connection is particularly important in this instance because, so far as I can determine, the federal government has never before tried to use the police power of the state to ban a particular line of biomedical research.
While there have been a variety of moral objections voiced against human cloning, the one that has most persuaded me is the two-fold argument that: (a) children have a right to their own genetic identity, an identify which, if not interfered with, will be unlike any other person's identify; and that (b) parents ought not to manufacture children to their specifications or to serve their needs, even understandable needs.
Our moral and political tradition has always understood each of us to be individuals in our own right, to be accorded respect precisely because of our unique individuality. Human cloning would jeopardize that identity. It is true, as many scientists have noted, that a cloned human being would not, even genetically, be exactly like the person from whom he or she was cloned. It is also true that the different environmental and social context of the clone would lead to a person with many different traits and even personality. But twin studies have suggested that at least 50% of their personal traits are similar; and the simple fact that we would have the same appearance as the source of the clone is not something to be lightly dismissed. Common sense, moreover, suggests that there would be no point in cloning a person unless that person shared many of the traits of the genetic originator. The fact that genetically identical twins occur in nature does not, by itself, prove that it is acceptable to manufacture them.
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The very first question to be asked about human cloning is whether it would benefit the clone. That question is, surprisingly, hardly addressed at all by those favorable to cloning. The best that can be said is that some cloned children might not be alive at all but for the fact that its parents would or could only procreate in a way that would produce a clone. By far the greater emphasis of proponents has been a claim that the idea of reproductive rights can extend to cloning a child, and that once such a right is recognizedsatisfying the desires of the parentthen there is little more of moral interest to be said.
There is, in short, little apparent concern for what was not long ago called ''responsible parenthood.'' That important concept has been pushed aside by the seemingly unlimited notion of reproductive rights, not only the right to have or not have a child, but to have a child with the traits, any traits, of one's own choosing and procreated in any manner. Yet responsible parenthood is still an important concept, one that needs to be reinvigorated. To be sure, people have always had children to satisfy their own needs and interests: to carry on family lines, to care for them in old age, to provide helpers on the farm, to provide parents with the pleasure of having and raising children. But there has always been a powerful, and parallel, tradition that children are demeaned in their meaning and personhood if they are not loved and respected and reared for their own good and not that of the parents.
There is surely something of a paradox here in observing why people have childrenfor their own sake and that of the child at one and the same timebut the final desired outcome had been less mixed in its ideals. That outcome is simply that the child must grow into an adult who is his or her own person, shaped by, educated by, cherished by his or her parents, but not made in the image of, or according to the plan of, the parents. Jokes are often made about pushy parents, and sometimes children thank parents for moving them in one direction rather than another; but for children who have been forced to live up to some predetermined parental notion of what the child must be or do there can be, and often has been, great tragedy. To say each of us ought, in the end, to be our own person is to say it all. That cloning does not deprive someone entirely of his identity is beside the point. It badly compromises it, and that is grounds enough for condemnation.
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There is, however, a long-standing and important difference between ethics and law. The former is meant to shape our individual virtues and principles, and to provide a foundation for making distinctions between right and wrong, good and bad. The latter may and often does embody our ethical values, but its purpose is primarily to establish those rules and prohibitions necessary for a society to function well, in reasonable peace and harmony. Not every ethical principle or belief is appropriate for law, and not every law embodies moral principles (though law should never be incompatible with them).
So, even if we can come to some agreement that research on human cloning is wrong-headed, and morally wrong, does that mean that we should ban it? We could, after all, leave matters as they now stand, with a prohibition against federal grants to support such research, with most professional and public opinion hostile to it, and with little apparent interest in the private sector, which apparently sees no great profit in it. Would not that be enough to stop it from ever happening?
Probably not. Not only is there a minority body of scientific and lay opinion that human cloning is worth pursuit, but also some well-publicized instances of individuals and groups who have told us they will do the research necessary to produce a clone. They should be taken seriously. If they succeed, or others who come later do, then those of usand our children and our children's childrenwill have to live with the result: a radical change in the procreation of children, a change that offers a minor promise of some therapeutic benefit and a major promise of social harm.
But, even so, is that a good enough reason to enact a federal ban? A ban would be a most drastic response, unprecedented at the level of the combined basic and applied research that would be needed to create a human clone. That should be enough to give pause to anyone who appreciates the great contribution that a free science can make to our health and welfare. It is easy to imagine many scientists, legislators, and lay people agreeing that research on cloning to be morally wrong, like with most harmful consequencesand yet fearing the precedent for research restrictions that could be even worse in its consequences. Moreover, is not the dilemma made all the worse when it is proposed, as is the case with one bill before the House of Representatives, to ban not just direct research into human cloningcalled ''reproductive cloning''but also a ban on embryo cloning as well for research purposes, which might best be called ''cloning for research.''
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Such a proposed ban lays a heavy burden of proof on its proponents: to show that the harms to be averted are serious threats to the public interest; that dangerous precedents for the future of science would not be established; and that the loss to scientific research, of opportunities for knowledge foregone, would not be unacceptably high.
I believe that burden can be discharged. First, human cloning would change the nature of procreation and parenthood in a radical way and, in the process, change its social as well as individual meaning. There is good reason to believe such a change would be harmful and no good reason to believe such a change would produce any important benefit for procreation or, as often alleged, for the relief of infertility. As for the precedents that might be set, there has always been a recognition that scientific freedom is not an absolute value. The international covenants requiring informed consent for clinical research, for instance, draw a sharp line against the use of human being as research subjects against their willhowever great might be the research or medical benefits of doing so. Few seem to reject the idea that it would be wrong to put children at risk to make human cloning work. The physical safety of child-to-be who is part of human cloning research is taken to be a value overriding that of scientific knowledge or benefits to parental infertility.
Scientists with no particular interest in human cloning might, however, worry about the research opportunities that would be lost if legislation banned cloning for research as firmly as it banned cloning for reproduction. A strong reason for doing such research is to assist in stem cell investigations, which would be particularly helped if immunological incompatibility and tissue rejection problems can be overcome. Cloning could help solve that problem.
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Two points can be made in response. One of them is that it would be almost pointless to ban research on human cloning without banning researchcloning as well; the former would provide the necessary knowledge to do the latter, and would make it all the harder to have any kind of oversight over what would be done with the knowledge.
The second point is that, as with much of genetic and biomedical research, there is rarely anything such as a one-and-only way to gain knowledge, and this is as true of stem cell research and its potential clinical applications as it is of most other research. There is no reason in principle to say that, much less any way to show, that other approaches to stem cell research will and must failjust as there is no reason in principle to assume that research-oriented human cloning is the only way to deal with the immunological compatibility problem. This is not to deny there could be some scientific loss. Progress might come more slowly and with more difficulty with a ban in place; but even there the best one can say is ''might'' because there is no necessary correlation between methods that will at any historical moment appeal to scientists and those that will, in the long run, prove most successful.
If there are no exact precedents for a ban on research of this kind, it is worth noting that the National Bioethics Advisory Commission called for such a ban on reproductive cloning research ( though it also asked for a sunset-clause and Congressional Review after 35 years). France and Germany have enacted a ban on that kind of research as well. A ban on cloning for research purposes goes a step further, but it is the only logical way to help insure that research on reproductive cloning does not have other research off of which too easily to feed. It should be self-evident, finally, that a ban can be revoked, that science can change, that what seems methodologically valid at the moment can give way to methods even better in the future.
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Too much of the current research drive is fueled by a singleminded passion to eradicate disease, often likened to a war. The worst possible analogy for biomedical research is that of warfare. Illness, death, and suffering are terrible human threats, but to approach them as if nothing less than all-out battle, with no holds barred, will demonstrate our moral seriousness is a profound mistake. Health is a great and vital human good, but not the only such good. The point of a ban on research for human cloning is to make certain that some time-tested, critical means of human procreation and human individuality are protected. They are as important part of our American and Western heritage as freedom of scientific inquirya freedom that has well coexisted for some years with ethical limitations and has managed to flourish in the face of (and sometimes because of) those limitations.
Mr. SMITH. Thank you, Dr. Callahan. Dr. Prentice?
STATEMENT OF DAVID A. PRENTICE, Ph.D., PROFESSOR OF LIFE SCIENCES, INDIANA STATE UNIVERSITY
Mr. PRENTICE. Mr. Chairman and distinguished Members of the Subcommittee, thank you for the opportunity to testify today at this important hearing regarding human cloning. There is almost uniform agreement against what has been termed reproductive cloning, creating a cloned human being and allowing that clone to develop to a live birth, but some scientists proposed therapeutic cloning, the production of human embryos by cloning for the purpose of harvesting embryonic stem cells from the early embryo. But, is cloning really necessary for production of embryo stem cells? No. If necessary, those cells can be derived from so-called excess human embryos from in vitro fertilization. Proposals already exist to design methods to prevent transplant rejection.
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Of course, the debate will continue as to whether such excess human embryos should be donated to research or perhaps instead adopted through programs such as the Snowflakes Embryo Adoption Program. The real crux of the debate rests on the necessity for embryonic stem cells for regenerative medicine; are they really necessary? Is there the potential for these cells to provide actual clinical treatments for disease versus other, less ethically contentious alternatives? There is no dispute that embryonic stem cells, the inner cells of the very early embryo, have the potential to produce all human tissues under normal developmental circumstances, but despite the initial enthusiasm for the use of these cells, they have been disappointing.
Considerable technical problems remain to be surmounted, including the difficulty in growth and maintenance of the cells, slow growth rate of the cells, potential chromosomal instability, difficulty in directing the production of specific desired tissues and potential tumor formation. The National Bioethics Advisory Commission in September 1999 expressed it this way, ''In our judgment, the derivation of stem cells from embryos remaining following infertility treatments is justifiable, only if no less morally problematic alternatives are suitable for advancing the research.'' Such an alternative does exist, adult stem cells.
Since that first statement in 1999, there has been an avalanche of research reports describing success after success with adult stem cells. The published scientific research voids all the arguments that have been made against adults stem cells. Sufficient numbers of adults stem cells can be easily generated and cultured for clinical applications. A recent study showed that only one transplanted adult stem cell from bone marrow in a mouse could regenerate tissue in several parts of the body. That single, transplant in cell expanded in number sufficiently and in enough time to rescue the host mouse, into which it was transplanted from lethal irradiation. Since the original stem cell came from another mouse, you might term that technique mouse-to-mouse resuscitation.
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However, there have been various studies that now show adult stem cells from many tissues are pluri-potent. They have the ability to form many different tissues, in fact, the indications are adults stem cells can regenerate all human tissues. Examples include transformation of brain stem cells in the blood, umbilical cord blood into nerve, and bone marrow stem cells into an array of tissues such as cartilage, bone, muscle, liver, nerve endocardiac tissue. Even fat has been recently found to contain stem cells. Placenta is a rich source of stem cells. Adult stem cells have also shown that they can form functional tissues when injected into animal models. Bone marrow stem cells have been shown to transform into functional liver, muscle and even into heart tissue, repairing cardiac damage. Bone marrow and umbilical cord blood stem cells have been shown to provide therapeutic benefit after stroke in a mouse model.
Adult pancreatic stem cells have reversed diabetes in mice and bone marrow stem cells have regenerated muscle in a mouse model of muscular dystrophy. In addition, adult stem cells are already being used successfully for therapeutic benefit in humans, treatments associated with cancer, relieving lupus, multiple sclerosis, arthritis, immunodeficiencies, restoration of sight by regeneration of corneas. Initial clinical trials have begun to repair heart damage using the patient's own adult stem cells. The weight of published scientific evidence seems to clearly indicate an acceptable, less morally problematic alternative to embryonic stem cells does exist.
Adult stem cells are making good on what are only promises of embryonic stem cells. Now, if the purpose of human cloning is as a source of donor cells and tissues for others, there is no justification for such a practice. Therapeutic cloning takes a utilitarian view of human embryos, useful for a purpose, not valued in and of themselves. They are not viewed as people, but as property, a commodity. Dr. Irwin Chargaff, renowned biochemist, characterized this attitude as a kind of capitalist cannibalism. A complete ban on human cloning, as proposed in the Brownback-Weldon bill, is the only sufficient answer. Thank you, sir.
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[The prepared statement of Mr. Prentice follows:]
PREPARED STATEMENT OF DR. DAVID A. PRENTICE, PH.D.
Mr. Chairman, distinguished Members of the Subcommittee, thank you for the opportunity to testify today at this important hearing regarding human cloning.
There is almost uniform agreement against what has been termed ''reproductive cloning''creating a cloned human being and allowing that clone to develop to a live birth. And there are good scientific reasons for opposition to reproductive cloning. Of the half-dozen or so mammals which have been cloned thus far, almost all (9599%) do not survive, either dying during embryological development or soon after birth. It has even been said that there are no normal clones, in that even the few that survive after birth have various physiological problems, possibly genetic problems as well. This seems due to problems with the necessary re-programming of the genetic material in the transplanted nucleus to allow normal development. Cloning is thus a wasteful, inefficient, and even dangerous process for the clones themselves. In addition, the surrogate mothers of the clones experience physiological problems. In short, this whole notion is fraught with peril and should be banned.
But some scientists propose ''therapeutic cloning'', or euphemistically ''cellular replacement through nuclear transfer''. This involves production of human embryos by cloning for the purpose of harvesting embryonic stem (ES) cells from the early embryo. On the surface the goal seems nobleto produce genetically-matched tissues for clinical use. However, there are significant scientific problems with therapeutic cloning as well, revolving primarily around both the claim of the necessity for production of embryonic stem cells in this manner and the claim that embryonic stem cells are the only or the most promising route to clinical success in regenerative medicine.
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First in terms of the need for production of embryonic stem cells via cloning. The proposals for use of this technique cite the very real probability that ES cells from ''excess'' human embryos frozen for in vitro fertilization (IVF) will not be an immunological match for patients, leading to rejection of transplanted tissues created from such ES cells, as with organ transplant rejection. While this is a real possibility, there are research proposals to design methods to mask the incompatibilities of stem cells from any source, allowing the transplanted cells to be accepted in a transplant host. This would obviate the need to clone the patient in order to produce genetically-matched cells and tissues and ES cells, if necessary, could be derived from frozen IVF embryos. Of course, the debate continues as to whether such ''excess'' human embryos should be donated to research, or rather adopted through programs such as the Snowflakes embryo adoption program. Nonetheless, a telling point regarding the production of cloned human embryos for derivation of ES cells is that the Stem Cell Research Act of 2001 (S.723) introduced by Senators Specter and Harkin, which supports human embryonic stem cell research, still requires that the research involved shall not result in the creation of human embryos.
The crux of the debate regarding human cloning actually rests then on the necessity for production of embryonic stem cells for clinical use. Further, the question of the necessity of embryonic stem cells for ''regenerative medicine'' has to do with the potential of such human embryonic stem cells to provide actual clinical treatments for disease versus other, less ethically contentious alternatives. There is no dispute that embryonic stem cells, the inner cells of the very early embryo (approximately 59 days old), have the potential to produce all human tissues, under normal developmental circumstances. However, despite the initial enthusiasm for use of embryonic stem cells and the media hype, in laboratory cultures as well as in animal transplant experiments, embryonic stem cells have been disappointing. Considerable technical problems remain to be surmounted regarding both laboratory and potential clinical work with these cells, including the difficulty in growth and maintenance of the cells in culture, the relatively slow growth rate of ES cells, potential chromosomal instability of some ES lines, difficulty in directing specific desired differentiation of the cells, and potential tumor formation.
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The National Bioethics Advisory Commission (NBAC) expressed it this way in its report in September of 1999:
''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 science advances.''
Ethical Issues in Human Stem Cell Research, Volume I, (Rockville, MD; September 1999; p. 53
The question is thus whether a less morally problematic, and scientifically acceptable, alternative exists at this time. Such an alternative does exist: adult stem cells. The name is somewhat of a misnomer, since these same stem cells can be found in newborns as well as adults, and can also come from umbilical cords and placentas after delivery of an infant. A better term might be ''tissue stem cells'' or ''post-natal stem cells'', but since the term adult stem cells is widely known I will continue to use it here.
Since the NBAC statement in 1999, there has been an avalanche of research reports describing success after success with adult stem cells. Early detractors of adult stem cells raised several questions regarding these cells and their abilities. For example, it has been said that stem cells in adults are often present in only minute quantities, are difficult to isolate and purify, and their numbers may decrease with age, and further that any attempt to use stem cells from a patient's own body for treatment would require that stem cells would first have to be isolated from the patient and then grown in culture in sufficient numbers to obtain adequate quantities for treatment. Numerous research papers have voided these arguments. Studies have shown that previously reported human stem cell frequencies and their self-renewal activity have been markedly underestimated, and that sufficient numbers of adult stem cells can be easily generated in culture for clinical applications. In fact, a recent study showed that only one transplanted adult stem cell from bone marrow could possibly regenerate tissue in several parts of the body. The single transplanted bone marrow stem cell actually expanded its numbers sufficiently and in short enough time to rescue the host mouse in which it was transplanted from lethal irradiation, allowing the transplant recipient to survive. Since that single original stem cell came from another mouse, the technique could have been termed ''mouse-to-mouse resuscitation''.
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As far as difficulty in isolation of adult stem cells, this might be true were we to target extraction of neural stem cells from the brain. However, various studies now show that adult stem cells from many tissues are ''pluripotent'', that is, they have the ability to form many different tissues in the body, not just regenerate the one tissue from which they were taken. In fact, the indications are that adult stem cells can regenerate all human tissues. This potential answers another criticism, that an individual stem cell has not yet been found for each of the 210 tissues of the human body. The proven potential of adult stem cells to transform from one tissue type to another negates the necessity to find 210 different adult stem cells, since one or a small set can suffice. Examples include transformation of neural stem cells into blood,, umbilical cord blood stem cells into nerve, and bone marrow stem cells into an array of tissues as diverse as cartilage, fat, bone, muscle, liver, nerve, lung, gastrointestinal tissue, and cardiac tissue. Even fat was recently found to contain stem cells which show indications of the ability to transform into other tissue types. For our nation, this source might truly provide an unlimited quantity of stem cells. Another recent report suggests that the placenta is rich in stem cells which might be transformed into other tissues. And the Scottish company involved in the original cloning of Dolly the sheep, PPL Therapeutics, recently reported that they have developed a technique to reprogram normal adult somatic cells into pluripotent stem cells which can be induced to form almost any tissue; their original experiment involved turning a skin cell from a cow into a heart cell.
If the only thing that could be accomplished were to turn adult stem cells from one tissue type into another in a lab dish, then this would be simply a cute scientific trick. However, adult stem cells have shown that they can form functional tissues when injected into the body. Bone marrow stem cells have been shown to transform into functional liver and muscle; these adult stem cells could potentially ''mend broken hearts''the cells can transform into functional heart tissue, repairing cardiac damage. Bone marrow and umbilical cord blood stem cells have also been shown to migrate to the brain, and in published reports have provided therapeutic benefit after stroke in animal models. Adult pancreatic stem cells have reversed diabetes in mice and regenerated muscle in an animal model of muscular dystrophy.
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Adult stem cells are already being used successfully for therapeutic benefit in humans. This includes treatments associated with various types of cancer, to relieve systemic lupus, multiple sclerosis, rheumatoid arthritis, anemias, and immunodeficiency diseases, and restoration of sight through regeneration of corneas. And initial clinical trials have begun to repair heart damage using the patient's own adult stem cells. Per the NBAC statement, if we now revisit the science of stem cells, the weight of published scientific evidence would seem to clearly indicate that an acceptable, less morally problematic alternative to embryonic stem cells does exist. Adult stem cells are making good on what are only promises of embryonic stem cells.
On balance then, is it necessary to destroy some human beings to save other human beings? Is it ethical when viable alternatives exist? The evidence would indicate that it is neither necessary nor ethical. If the purpose of human cloning would be as a source of donor cells and tissues for others, there is no justification for such a practice. Therapeutic cloning takes a utilitarian view of human embryos, useful for a purpose and not valued in and of themselves. They are not viewed as people, but as property, a commodity. Dr. Erwin Chargaff, renowned biochemist, characterizes this attitude as ''a kind of capitalist cannibalism''.
To artificially try to separate types of human cloning based on the end purpose of the embryo is absurd. What is to prevent embryos which have been manufactured for destruction and harvesting of embryonic stem cells from being implanted into the uterus? If production in the laboratory of cloned humans for the purpose of embryonic stem cell harvesting results in excess embryos beyond that of clinical need, will these excess embryos simply be discarded? Will they be frozen for storage? How would stored embryos created by cloning be distinguished from stored embryos created by in vitro fertilization? The techniques used for reproductive cloning and therapeutic cloning are identical, only the intent for use of the cloned human being is different. And how are we to judge intent? How shall we provide oversight of intent?
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A complete ban on human cloning as proposed in the Brownback-Weldon bill is the only sufficient answer.
Mr. Chairman, distinguished Members, I thank you for the opportunity to provide testimony on this important issue, and I would be pleased to answer any questions.
PLURIPOTENT NATURE OF ADULT STEM CELLS
Showed the ability of a single adult bone marrow stem cell to repopulate the bone marrow of mice, forming functional marrow and blood cells, and also differentiate into functional cells of liver, lung, gastrointestinal tract (esophagus, stomach, intestine, colon), and skin. Indications that it could also form functional cells in heart and skeletal muscle. Evidence that the stem cells ''home'' to sites of tissue damage.
Reference: Krause DS et al.; ''Multi-Organ, Multi-Lineage Engraftment by a Single Bone Marrow-Derived Stem Cell''; Cell 105, 369377; May 4, 2001
Research with mice indicates that adult stem cells from brain can grow into a wide variety of organsheart, lung, intestine, kidney, liver, nervous system, muscle, and other tissues. The study by Swedish scientists, reported in the June 2, 2000 issue of Science, confirms that adult stem cells are in fact much more adept at redefining themselves than previously thought. The study involved growing adult stem cells from brain with embryonic cells and within an embryo. Even lone neural adult stem cells had the ability to differentiate into various cell types. The authors observe that the ''most striking indication'' of this complete cellular redefinition was the finding of apparently normal and beating embryonic mouse hearts that contained very large amounts of the stem cells.
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According to Dr. Ihor Lemischka, professor of developmental biology at Princeton University, ''This is a very exciting and interesting result,'' and if the research can be confirmed in human cells it would ''nip in the bud'' the moral and ethical concerns that now block federal funding of human embryonic stem cell research. The authors of the study state that ''This demonstrates that an adult neural stem cell has a very broad developmental capacity and may potentially be used to generate a variety of cell types for transplantation in different diseases.'' They also note that ''. . . these studies suggest that stem cells in different adult tissues may be more similar than previously thought and perhaps in some cases have a developmental repertoire close to that of ES cells.''
Reference: Clarke et al.; ''Generalized potential of adult neural stem cells''; Science 288, 16601663, June 2, 2000.
STEM CELLS FROM FAT
Isolated adult stem cells from HUMAN fat. Cells could be expanded and maintained in culture for extended periods, and could be differentiated into fat, cartilage, muscle, and bone. Characteristics similar to bone marrow stem cells.
Reference: Zuk PA et al.; ''Multilineage cells from human adipose tissue: Implications for cell-based therapies''; Tissue Engineering 7, 211228; 2001
STEM CELLS FROM PLACENTA
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Anthrogen, Inc. in a press release reports that they can isolate stem cells from placenta after delivery, and that these stem cells so far have been induced to form bone, nerve, cartilage, bone
REPAIRING CARDIAC DAMAGE
Used bone marrow stem cells from mice expressing green fluorescent protein to track the cells. Injected the stem cells into area of heart where damage had been induced. Newly formed myocardium occupied 68% of the infarcted portion of the ventricle 9 days after transplanting the bone marrow cells. The developing tissue comprised proliferating myocytes and vascular structures. The studies indicate that locally delivered bone marrow cells can generate de novo myocardium, ameliorating the outcome of coronary artery disease.
Reference: Orlic D et al.; ''Bone marrow cells regenerate infarcted myocardium''; Nature 410, 701705; April 5, 2001
Human bone-marrow-derived stem cells were implanted into rats with cardiac damage. The cells participated in formation of new cardiac blood vessels and stimulated existing vessels. The authors note that ''The use of cytokine-mobilized autologous human bone marrowderived angioblasts for revascularization of infarcted myocardium (alone or in conjunction with currently used therapies) has the potential to significantly reduce morbidity and mortality associated with left ventricular remodeling.''
Reference: Kocher AA et al.; ''Neovascularization of ischemic myocardium by human bone-marrow-derived angioblasts prevents cardiomyocyte apoptosis, reduces remodeling and improves cardiac function''; Nature Medicine 7, 430436; April 2001.
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Cell transplantation is a potential therapeutic approach for patients with chronic myocardial failure. Experimental transplantation of neonatal and fetal cardiac myocytes showed that the grafted cells can functionally integrate with and augment the function of the recipient heart. Clinical application of this approach will be limited by shortage of donors, chronic rejection, and because it is ethically contentious. By contrast skeletal myoblasts (satellite cells) are abundant and can be grafted successfully into the animal's own heart even after genetic manipulation in vitro.
Reference: El Oakley RM et al.; ''Myocyte transplantation for cardiac repair: A few good cells can mend a broken heart''; Ann Thorac Surg 71, 17241733; 2001
Marrow Stromal Cells delivered to ischemic brain tissue through an intravenous route in rats provide therapeutic benefit after stroke. MSCs may provide a powerful autoplastic therapy for stroke.
Reference: Chen J et al.; ''Therapeutic benefit of intravenous administration of bone marrow stromal cells after cerebral ischemia in rats''; Stroke 32, 10051011; April 2001
These data suggest that intracerebral transplantation of bone marrow could potentially be used to induce plasticity in ischemic brain.
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Reference: Li Y et al.; ''Adult bone marrow transplantation after stroke in adult rats''; Cell Transplant 10(1), 3140; Jan-Feb 2001
Researchers at the University of South Florida have reported at the meeting of the American Association for the Advancement of Science (Jan 2001) and the American Academy of Neurology meeting (May 2001) that human cord blood stem cells can be induced to form neurons. When injected into the bloodstream of rats which had suffered stroke, the adult stem cells found their way to the brain and repaired much of the damage. Rats which were previously paralyzed showed 80% recovery.
TREATING MUSCULAR DYSTROPHY
Multipotent stem cells were isolated from mouse muscle, capable of differentiating into muscle and multiple blood cell types. The adult stem cells were injected into bloodstream of mdx mice, a model of Duchenne muscular dystrophy. The stem cells migrated to muscle, participated in formation of muscle fibers, and helped in regeneration of muscle and restoration of production of dystrophin protein, which is deficient in muscular dystrophy.
Reference: Torrente Y et al.; ''Intraarterial injection of muscle-derived CD34+Sca-1+ stem cells restores dystrophin in mdx mice''; Journal of Cell Biology 152, 335348; January 22, 2001
Page 65 PREV PAGE TOP OF DOC Segment 1 Of 2 Were able to reverse diabetes in mice using the animals' own adult stem cells; after treatment, the mice no longer needed insulin shots to survive.
Reference: Ramiya VK et al.; ''Reversal of insulin-dependent diabetes using islets generated in vitro from pancreatic stem cells''; Nature Medicine 6, 278282; March 2000
TRANSFORMING BONE MARROW TO BRAIN
Adult stem cells from mouse bone marrow injected into mouse blood stream, could be found developing neuron characteristics in brain. Generation of brain cells from adult bone marrow ''demonstrates a remarkable plasticity of adult tissues with potential clinical applications.''
Reference: Brazelton TR et al.; ''From marrow to brain: expression of neuronal phenotypes in adult mice''; Science 290, 17751779; Dec 1 2000
Showed in mice that intraperitoneally transplanted adult bone marrow stem cells can migrate into brain and differentiate into neuronal cells. ''These findings raise the possibility that bone marrow-derived cells may provide an alternative source of neurons in patients with neurodegenerative diseases or central nervous system injury'';
Reference: Mezey E et al.; ''Turning blood into brain: Cells bearing neuronal antigens generated in vivo from bone marrow''; Science 290, 17791782; Dec 1 2000
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ADULT STEM CELLS CAN MIGRATE WITHIN BRAIN TO SITES OF DAMAGE
Implanted neural stem cells infiltrate brain tumors. The neural stem cells show the ability to migrate extensively throughout the brain to reach sites of damage. The results ''suggest that NSC migration can be extensive, even in the adult brain and along nonstereotypical routes.''
Reference: Aboody KS et al., ''Neural stem cells display extensive tropism for pathology in adult brain: evidence from intracranial gliomas''; Proc Natl Acad Sci U S A 97, 1284612851; Nov 7 2000
GENERATION OF NERVES STARTING WITH A SINGLE ADULT STEM CELL
Cultures of adult stem cells from spinal cord can be grown from single cells, and can differentiate into neural cells when injected into the spinal cord or brain of rats. The adult stem cells generate region-specific neurons in the body, including neurons, astrocytes, oligodendrocytes, and glial cells.
Reference: Shihabuddin S et al.; ''Adult spinal cord stem cells generate neurons after transplantation in the adult dentate gyrus''; J Neuroscience 20, 87278735; December 2000
LARGE-SCALE GROWTH OF ADULT STEM CELLS
Page 67 PREV PAGE TOP OF DOC Segment 1 Of 2 Human and animal adult stem cells shown to be able of extensive proliferation in culture, providing potentially unlimited supplies of adult stem cells for clinical treatments.
Bhardwaj G et al. ''Sonic hedgehog induces the proliferation of primitive human hematopoietic cells via BMP regulation'', Nature Immun. 2, 172180; 2001
Cashman JD and Eaves CJ; ''High marrow seeding efficiency of human lymphomyeloid repopulating cells in irradiated NOD/SCID mice''; Blood 96, 39793981; Dec. 1 2000
Gilmore GL et al.; ''Ex vivo expansion of human umbilical cord blood and peripheral blood CD34(+) hematopoietic stem cells''; Exp. Hematol. 28, 12971305; Nov 1 2000
Woodbury D et al.; ''Adult rat and human bone marrow stromal cells differentiate into neurons''; J. Neuroscience Research 61, 364370; August 15, 2000
SOME CURRENT CLINICAL APPLICATIONS OF ADULT STEM CELLS
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Dunkel, IJ; ''High-dose chemotherapy with autologous stem cell rescue for malignant brain tumors''; Cancer Invest. 18, 492493; 2000.
Kawa, K et al.; ''Long-Term Survivors of Advanced Neuroblastoma With MYCN Amplification: A Report of 19 Patients Surviving Disease-Free for More Than 66 Months''; J Clin Oncol 17:32163220; October 1999
Abrey, LE et al.; ''High dose chemotherapy with autologous stem cell rescue in adults with malignant primary brain tumors''; J. Neurooncol. 44, 147153; Sept., 1999
Schilder, RJ and Shea, TC; ''Multiple cycles of high-dose chemotherapy for ovarian cancer'' Semin. Oncol. 25, 349355; June 1998;used autologous, purified peripheral blood stem cells
Schilder, RJ et al.; ''Phase I trial of multiple cycles of high-dose chemotherapy supported by autologous peripheral-blood stem cells''; J. Clin. Oncol. 17, 21982207; July 1999 used for malignant solid tumors. Overall response rate 96%, complete clinical response rate 67%.
Page 69 PREV PAGE TOP OF DOC Segment 1 Of 2 Vesole, DH et al.; ''High-Dose Melphalan With Autotransplantation for Refractory Multiple Myeloma: Results of a Southwest Oncology Group Phase II Trial''; J Clin Oncol 17, 21732179; July 1999.
Stiff P et al.; ''Autologous transplantation of ex vivo expanded bone marrow cells grown from small aliquots after high-dose chemotherapy for breast cancer''; Blood 95, 21692174; March 15, 2000
Koc, ON et al.; ''Rapid Hematopoietic Recovery After Coinfusion of Autologous-Blood Stem Cells and Culture-Expanded Marrow Mesenchymal Stem Cells in Advanced Breast Cancer Patients Receiving High-Dose Chemotherapy''; J Clin Oncol 18, 307316; January 2000
Josting, A; ''Treatment of Primary Progressive Hodgkin's and Aggressive Non-Hodgkin's Lymphoma: Is There a Chance for Cure?''; J Clin Oncol 18, 332339; 2000
(multiple sclerosis, systemic lupus, juvenile rheumatoid arthritis, rheumatoid arthritis)
Traynor AE et al.; ''Treatment of severe systemic lupus erythematosus with high-dose chemotherapy and haemopoietic stem-cell transplantation: a phase I study''; Lancet 356, 701707; August 26, 2000
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Burt, RK and Traynor, AE; ''Hematopoietic Stem Cell Transplantation: A New Therapy for Autoimmune Disease''; Stem Cells 17, 366372; 1999
Burt RK et al.; ''Hematopoietic stem cell transplantation of multiple sclerosis, rheumatoid arthritis, and systemic lupus erythematosus''; Cancer Treat. Res. 101, 157184; 1999
Martini A et al.; ''Marked and sustained improvement 2 years after autologous stem cell transplant in a girl with system sclerosis''; Rheumatology 38, 773; August 1999
Gonzalez MI et al.; ''Allogeneic peripheral stem cell transplantation in a case of hereditary sideroblastic anaemia''; British Journal of Haematology 109, 658660; 2000
Kook H et al.; ''Rubella-associated aplastic anemia treated by syngeneic stem cell transplantations''; Am. J. Hematol. 64, 303305; August 2000
Kondziolka D et al.; ''Transplantation of cultured human neuronal cells for patients with stroke''; Neurology 55, 565569; August 2000
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Schwab IR et al.; ''Successful transplantation of bioengineered tissue replacements in patients with ocular surface disease''; Cornea 19, 421426; July 2000.
Tsai et al.; ''Reconstruction of damaged corneas by transplantation of autologous limbal epithelial cells.''; New England Journal of Medicine 343, 8693, 2000.
Tsubota K et al.; ''Treatment of severe ocular-surface disorders with corneal epithelial stem-cell transplantation''; New England Journal of Medicine 340, 16971703; June 3, 1999
Osteogenesis imperfecta (leads to bone and cartilage deformities)
Horwitz, EM et al.; ''Transplantability and therapeutic effects of bone marrow-derived mesenchymal cells in children with osteogenesis imperfecta''; Nat. Med. 5, 309313; March 1999.
Cavazzana-Calvo M et al.; ''Gene therapy of human severe combined immunodeficiency (SCID)-X1 disease''; Science 288, 669672; April 28, 2000
*First successful trial of human therapy, re-injecting the infants' own bone marrow stem cells containing a normal copy of the gene that they lacked.
Page 72 PREV PAGE TOP OF DOC Segment 1 Of 2 Disclosure of federal grants, contracts, or subcontracts received in the current and preceding two fiscal years
National Institutes of Health
Indiana University School of Medicine, Indiana University-Purdue University at Indianapolis (collaborative research sub-contract with Dr. David A. Williams); 1 January 200031 July 2000; $11,000; ''Molecular and Functional Characterization of a Novel Mutation in Murine Stem Cell Factor''
National Institutes of Health
Indiana University School of Medicine, Indiana University-Purdue University at Indianapolis (collaborative research sub-contract with Dr. David A. Williams); 1 August 200030 June 2001; $16,000; ''Molecular and Functional Characterization of a Novel Mutation in Murine Stem Cell Factor'' (renewal)
There is almost uniform agreement against ''reproductive cloning''creating a cloned human being and allowing that clone to develop to a live birth. But some scientist propose ''therapeutic cloning'', production of human embryos by cloning for the purpose of harvesting embryonic stem (ES) cells.
If necessary, ES cells can be derived from ''excess'' human embryos frozen for in vitro fertilization. But are ES cells really necessary for regenerative medicine? Despite the initial enthusiasm, ES cells to date have been disappointing. A less morally problematic and scientifically viable alternative existsadult stem cells. Studies have shown that sufficient numbers of adult stem cells can be generated in culture for clinical applications. Even one transplanted adult stem cell from bone marrow could possibly regenerate tissue in several parts of the body. Various studies now show that adult stem cells from many tissues are ''pluripotent'', with the ability to form many different tissues. The indications are that adult stem cells can regenerate all human tissues. Examples include transformation of neural stem cells into blood, umbilical cord blood stem cells into nerve, and bone marrow stem cells into an array of tissues as diverse as cartilage, fat, bone, muscle, liver, nerve, lung, gastrointestinal tissue, and cardiac tissue. Even fat was recently found to contain stem cells. Another report suggests that placenta is rich in stem cells. And the Scottish company involved in the original cloning of Dolly the sheep, PPL Therapeutics, has reported that they have developed a technique to reprogram normal adult somatic cells into pluripotent stem cells which can be induced to form almost any tissue.
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Adult stem cells have shown that they can form functional tissues when injected into the body. Bone marrow stem cells have been shown to transform into functional liver and muscle, as well as functional heart tissue, repairing cardiac damage. Bone marrow and umbilical cord blood stem cells have also been shown to migrate to the brain and provide therapeutic benefit after stroke in animal models. Adult pancreatic stem cells have reversed diabetes in mice and regenerated muscle in an animal model of muscular dystrophy.
Adult stem cells are already being used successfully for therapeutic benefit in humans. This includes treatments associated with various types of cancer, to relieve systemic lupus, multiple sclerosis, rheumatoid arthritis, anemias, and immunodeficiency diseases, and restoration of sight through regeneration of corneas. And initial clinical trials have begun to repair heart damage using the patient's own adult stem cells. An acceptable, ethical alternative to embryonic stem cells does exist. Adult stem cells are making good on what are only promises of embryonic stem cells.
Therapeutic cloning is therefore unnecessary and unjustifiable. It takes a utilitarian view of human embryos, viewing them not as people, but as property, a commodity; this is ''a kind of capitalist cannibalism''''. It will be virtually impossible to provide oversight of the intent for cloning a human embryo, or distinguishing stored IVF embryos from stored cloned embryos. A complete ban on human cloning as proposed in the Brownback-Weldon bill is the only sufficient answer.
Mr. SMITH. Thank you, Dr. Prentice. Ms. Shapiro, we have you down as both doctor and Ms. Which would you prefer?
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Ms. SHAPIRO. Attorney.
Mr. SMITH. We can say Counselor Shapiro then.
STATEMENT OF ROBYN S. SHAPIRO, PROFESSOR OF BIOETHICS, MEDICAL COLLEGE OF WISCONSIN
Ms. SHAPIRO. Perfect, thank you. It is a pleasure to be here. I am not here, though, to stand by Richard Seed's side and advocate that we immediately clone a human being. What I am here to do today is to point out my concerns about any prospective notion of criminalizing cloning. Unfortunately, Dolly the sheep set off a frenzy of horrific and hypothetical human cloning scenarios, which were picked up by the press in large measure as evildoers or rich people cloning themselves time and time again, middleman deciding that they were going to hire women to bear the clones of Michael Jordan or Michael Jackson or somebody like that. This tended to overlook the potential benefits of cloning, which are enormous.
With cloning animal cells and tissues with particular traits and a high degree of DNA similarity can be produced much more easily, and for that reason, there is tremendous interest on the part of so many for progressing with these advances. Veterinary geneticists, agricultural biotechnology experts firmly support cloning animals to do things like replicating transgenic cows or sheep that have been genetically engineered to produce in their milk therapeutic proteins that are valuable to humans. When we get to the human side, facilitating the integration of DNA synthesis and new reproductive technologies through cloning allows us to greatly advance cellular and tissue transplants by allowing us to clone genetically matched cells and tissues for transplantation into patients who suffer from disorders that result from tissue loss or tissue dysfunction.
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Beyond that, we have the capability through cloning of being able to turn human cells into specific tissue types, to regenerate nerve cells in individuals with Parkinson's or Alzheimer's or heart muscle cells in those with heart disease; and additional positive spinoffs of cloning in the field of genetic engineering include producing human proteins, like blood clotting factors that can help us heal wounds. We also, down the line, perhaps would see important benefits from cloning in human reproduction. If both a male and a female in a couple had a recessivecarried a recessive gene for a serious disorder, cloning might allow them, down the road, to avoid conceiving an embryo with that disorder and thereby avoid the prospect of having to choose abortion.
The regulation that we have today applicable to human cloning seems appropriate to me. In 1997, the White House issued a directive on cloning, applicable both to research and to clinical applicationthat bans all Federal funding for human cloning. We have Federal regulations applicable to all federally funded human subjects research and under these where safety concerns about human cloning certainly would preclude IRB approval of any advance along those lines. The Food and Drug Administration has claimed that clinical research using cloning technology to create a human being is subject to its jurisdiction, under the Public Health Service Act and also the Food, Drug and Cosmetic Act. There is some controversy about whether they are right, but they claim that to be true and they intend to exercise that jurisdiction.
So, if we were to move beyond that to any thought of criminalizing cloning, we would encounter some ill-advised effects, I believe. First and probably foremost, there are real dangers in mixing medical and scientific work with criminalization. If a statute were to create criminal penalties, for example, for the performance of any somatic cell nuclear transfer in order to create a human being (and that is what many proposals have suggested) enforcement really would require monitoring the intent of scientists engaged in what may very well be very beneficial research, and that certainly would create a huge and disturbing, chilling effect on scientific inquiry.
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Added to this problem of trying to come up with a criminal prohibition that would be appropriately circumscribed and that could be easily enforced are problems of obsolescence. It is likely that any statute that we could conceive of that would criminalize human cloning would be outpaced by technological advancesand we have already seen that. In California, they have a statute that prohibits cloning and that uses a definition of cloning that uses the term ''human'' when talking about enucleated eggs. In other words, it prohibits putting the DNA from another cell into a human enucleated egg. That could be evaded, for example, by using a cow's enucleated egg to incubate the nucleic DNA of a human, which certainly appears feasible in light of our very own University of Wisconsin researcher's success in using enucleated cow eggs to serve as incubators for other mammalian species' nucleic DNA.
Finally, with all due respect, any Congressional act that would create criminal penalties for human cloning would open important aspects of scientific development to political tug-of-war, and we have seen this with debates about fetal tissue and embryonic research. The risk is that we will end up with laws that cover too much for reasons that do not have to do with human cloning, and that, unfortunately, make it impossible to attain the promises of the technology. So, given all these hazards, the three main hazards that I pointed out, criminalizing cloning because human cloning, at the moment, is unsafe and/or because certain applications of the technology would be unethical, threatens, unnecessarily, given the regulation we currently have, to stifle scientific progress.
To balance the dangers that I have talked about against the promise of the research, which is significant, informed regulation, to me, seems the better approach and this has worked in the past. We have to recall, in the 1970's, that there were heated discussions about how to prevent abuses of recombinant DNA technology. Some called for criminalization. We did not get that. We got standards; we got guidelines and we certainly have seen the benefits, the huge benefits in medicine, of those advances. We need to ensure that our approach today to cloning similarly allows research in the field to progress.
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[The prepared statement of Ms. Shapiro follows:]
PREPARED STATEMENT OF ROBYN S. SHAPIRO, J.D.
The debate about human cloning raises a number of important ethical, legal, and social issues. While the emotionally-charged nature of the issues now has led some to insist that human cloning should be criminalized, a more appropriate approach is to assure, through regulation or guidelines, that cloning technology is used to enhance, rather than limit, individual freedom and welfare.
Dolly the sheepthe first mammal to be cloned from a single adult cellset off a frenzy of horrific hypothetical human cloning scenarios, including evil-doers or rich or powerful persons cloning themselves time and again, or commercial entrepreneurs hiring women to bear clones of movie stars or sports heroes to sell to others. But the potential benefits of cloning are enormous. For example, animals, cells and tissues with particular traits and a high degree of DNA similarity can be produced much more easily. For this reason, veterinary geneticists and agricultural biotechnology experts firmly support cloning in animals in order to advance animal research (for example, replicating transgenic cows or sheep that have been genetically engineered to produce in their milk therapeutic proteins valuable to humanssuch as clotting factors or hormones). Perhaps more importantly, by facilitating the integration of DNA synthesis and new reproductive technologies, cloning will greatly advance cellular and tissue transplants by allowing us to clone genetically matched cells and tissues for transplantation into patients suffering from a variety of disorders that result from tissue loss or dysfunction. Beyond that, therapeutic cloning has the capability of turning human cells into specific tissue typesto regenerate nerve cells in patients suffering with Parkinson's or Alzheimer's, or heart muscle cells in those with heart disease. Additional positive spin-offs of cloning in the field of genetic engineering include the production of human proteins such as blood clotting factors that aid in healing wounds. Research on somatic-cell nuclear transfer will also yield important information on stem cell differentiation, which could provide valuable information about the mechanism of aging and the causes of cancer. Cloning also may offer important potential benefit in human reproduction. For example, if both the male and female in a couple carried a recessive gene for a serious disorder, cloning would allow them to avoid conceiving an embryo with the disorder and thereby avoid the prospect of selective abortion.
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The regulation currently applicable to human cloning seems appropriatefor now. A 1997 White House Directive on Cloning, applicable to both research and clinical application, bans all federal funds for human cloning; under regulations applicable to federally-funded human subjects research, safety concerns would preclude approval of human cloning research; and the Food and Drug Administration has claimed that clinical research using cloning technology to create a human being is subject to FDA regulation under the Public Health Service Act and the Food, Drug and Cosmetic Act.
Moving beyond that regulation to criminalization of cloning would be ill-advised. First, there are significant dangers in criminalizing medical and scientific work. If a statute were to create criminal penalties, for example, for the performance of any somatic cell nuclear transfer in order to create a human being, enforcement would require monitoring the intent of scientists engaged in beneficial researchthereby creating a disturbing chilling effect on scientific inquiry.(see footnote 2)
Added to problems of crafting a criminal prohibition that would be appropriately circumscribed and capable of being reasonably enforced are problems of obsolescence. It is likely that any statute criminalizing human cloning would be outpaced by technological advances. California's statute prohibiting cloning, for example, uses a definition of cloning that uses the term ''human'' when referencing enucleated eggs.(see footnote 3) That statutory prohibition could be evaded by using 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.
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Moreover, any Congressional act creating criminal penalties for human cloning 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.
Given these hazards, criminalizing cloning because human cloning currently is unsafe and/or because some applications of the technology would be unethical threatens unnecessarily to stifle scientific progress. To balance these dangers against the promise of research, informed regulation seems the better approach. This approach has worked in the past. In the 1970's, there were heated discussions about how to prevent abuses of recombinant DNA technology. While guidelines and standards were adopted, criminal legislation was not passed, and this technology certainly has yielded tremendous benefits in medicine. We need to assure that our approach to regulating cloning similarly allows research in the field to progress.
Mr. SMITH. Thank you, Ms. Shapiro. Let me thank you all for your testimony, as well, and we will now go to our question period.
Let me begin, Dr. Kass, with a question for youand by the way, I noticed in your more extensive written testimony, and all your testimonies will be made a part of the record without objectionthat you have been writing on human cloning since 1967. I'm tempted to ask you what gave you the idea in 1967 the we would be wrestling with human cloning?
Dr. KASS. The first cloning of frogsthere was an article in the Washington Post by Joshua Letterburg saying that if we could develop this for human beings we could end the unpredictable variety that comes as a result of sex.
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Mr. SMITH. I was just curious. That was not a legitimate first question, but it does seem to me that we are wrestling with trying to establish a balance, as described by Dr. Callahan, and that is a balance between the need for free scientific inquiry and the need to establish ethical standards. You really do have to have some restraint on what we do. Dr. Kass and Dr. Callahan, my first question is really why do you believe that we do need to have criminal penalties and ban human cloning; and why do you not think that current regulations are sufficient, as Ms. Shapiro does?
Dr. KASS. Well, the first point is that I treat the danger as much greater than Ms. Shapiro does. I think we stand on the threshold of something terribly important and that merely withholding Federal funds, and having Federal regulations of research done with Federal funds, does not touch what goes on in the private sector where this research is proceeding pell-mell, and under great secrecy, partly conditioned by the competition in the field.
Second, in vitro fertilization, which we have lived with and has brought great benefits to many infertile couples, is a completely unregulated and unstudied practice. If this goes on, not covered by the FDA, and were the clonal embryos available created commercially, they could be bought and sold and used in reproductive clinics and no one would know. So, I think that if we regard this as a serious and important matter and that we see this as an opportunity to place the burden of proof on the other side to say we absolutely have to have human cloning for these and these reasonsand I do not think they can meet that burdenthis is the time to do it and to put down this marker.
Mr. SMITH. Dr. Callahan, do you agree with that?
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Mr. CALLAHAN. I very much agree. I would simply add that I think it would be extraordinarily difficult to regulate the private sector. This would require a great deal of snooping around laboratories, of trying to find out what is going on, breaking through proprietary restraints. We find it very difficult now to know what's going on in the private sector. This would be very difficult particularly if the scientist and whoever was doing it knew that it was likely to be controversial research, they would do everything possible, it seems to me, to make it difficult to find out what they were doing. It seems to me that this is one of those horrible situations. Regulation seems the moderate, reasonable, middle way to go, but I simply don't think it would effectively work and, hence, we have to go a more Draconian route.
Mr. SMITH. Dr. Callahan, one more questiona lot of people are concerned, I think, that we, in our scientific discoveries, might gain the world, but sell our soul at the same time. You mentioned in your written testimony that scientific freedom is not an absolute value. Aren't there other instances where we have banned or prohibited scientific experiments as unethical or criminal, and this is not unprecedented, were we to go in this direction?
Mr. CALLAHAN. Well, certainly, a number of European countries have already banned cloning. I guess what is different here is that this research is at what might be called the basicsomewhere between basic and applied researchand there I think it is probably difficult to find very good legal precedents for efforts to ban research at that level, but other countries have indeed done it, for many of the reasons Dr. Kass has presented. It seems to me that when one is faced with what seems to be a very difficult decision, you really have to ask the question what is going to be good for us in the long run?
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Science is doing terrific these days. The National Institute of Health has lots of money. The private sector has money. The public sector has money. Research will go forward. Some research may be slowed down. Some may be slightly harmed, but it seems to me, in general, we are going to find it very much in the whole biological realm in years to come, and this is not going to make a great deal of difference if it is stopped.
Mr. SMITH. Thank you, Dr. Callahan. Dr. Prentice, you made the point that there are alternatives to the medical benefits that we might enjoy from cloning and you mentioned adult stem cells as an example. What if it were shown or proved that we really could not achieve everything that we wanted to in the way of medical advances by using adult stem cells? Would you still be opposed to human cloning and if so, why?
Mr. PRENTICE. Yes, Mr. Chairman, I would, and I think it relates back more to the idea what some people have termed human dignity. I think the vast weight of scientific evidence says that it is probably the other way around, that the embryonic stem cells are not going to be able to make good on those sorts of promises and the adult cells are already doing that. But, I think it comes back to the idea of a human being and the way we view humanity or how we view ourselves as a society, and science tells us that even at one cell we are a human being. This is not some other species, not fish nor fowl. It is a question now of how we view other members of our species. I think this is a particular route down which we just do not need to go.
Mr. SMITH. Thank you, Dr. Prentice. I'm going to say Dr. Shapiro. I think all attorneys should be called doctor because of J.D.s.
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Mr. SMITH. My time this up, but let me squeeze in one brief question and that is, I understand your point about relying on current regulation rather than criminalize human cloning. A couple of your objections, though, to me, seem to be technical in the sense that they could be overcome. You mentioned enforcement problems. You mentioned definitional problems. It seems to me if you write the laws well or if you update the legislation, you can address those kinds of concerns. Therefore, we could justify going beyond just the regulations. Do you want to comment on that?
Ms. SHAPIRO. Two responses. One is I hope that is true, but problems in doing that could happen on account of the third factor that I mentioned, and that is the political tug-of-war aspect of all of this. Probably the most important response I would have to that is the chilling effect that a statute like that would have regardless. That is, even if we could try to craft it very specifically, we have seen physicians and scientists could read it in a different way, and if the threat of going to jail for life is hanging over them, they are very likely to be conservative about what might be permissible.
Mr. SMITH. Thank you, Dr. Shapiro. The gentleman from Virginia, the Ranking Member, Mr. Scott, is recognized for his questions.
Mr. SCOTT. No questions.
Mr. SMITH. The gentlewoman is recognized.
Mr. JACKSON LEE. Let me thank the witnesses very much, and please accept my apologiesI was detained on the floor of the Housefor not hearing the testimony of earlier witnesses, but I have had the opportunity and will have the opportunity further to review your testimony. Let me applaud the legislation's intent. I am going to remain openthat is what hearings are for, as we move toward trying to find the best solution. I do want to commend Dr. Weldon for the intent and his reaching out to Members of this Committee and others to further explain this particular legislation.
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The first, if you will, response to human cloning is for those of us who grew up on Frankenstein, is extremely negative. Frankly, as we watched that creation, we didn't want to add to it. It may not have been cloning. It may have been just be piecing things together, but we are in a new century and I think we have to be open minded on what helps us to solve today's problems, particularly medical research. Might I, Dr. Shapiro, since we are going to adhere to the new title, probe you a little bit and then I have some questions for the other individuals? I want to pursue your line of reasoning on the chilling effect, which, I think, has great merit. I would offer and ask you how this might reach out into stem cell research, which is so important for people suffering from Parkinson's disease and other aspects, and tell me where that would reach if you are talking about in vitro fertilization? I am interested in the concept of banning implantation for scientific research, but possibly the work you do in the lab can be distinguished, because hopefully you are there in the lab to do good, as opposed to do ill. Would you comment on those two concepts, please?
Ms. SHAPIRO. Sure. I think part of your question actually is your answer, and that is, in my mind, the threat, the chilling effect threat, could very well reach to reluctance or refusal on the part of scientists and medical personnel to explore stem cell research and/or even in in vitro fertilization, and we certainly have seen the promise and the reality of the benefits of those procedures. In terms of prohibiting implantation, we heard remarks earlier about what European countries are doing, and actually Britain is allowing for embryonic cloning as long as there is no implantation, on account of just what you're suggesting; that is, that the research is potentially very beneficial, but we want to avoid creating a cloned human being.
Page 85 PREV PAGE TOP OF DOC Segment 1 Of 2 Mr. JACKSON LEE. You are from the medical school in Wisconsin, as I understand.
Ms. SHAPIRO. Yes.
Mr. JACKSON LEE. Research is done at the school, to your knowledge?
Ms. SHAPIRO. Well, actually, there are two medical schools. I am from the Medical College of Wisconsin and a mere hour-an-a-half away is the University of Wisconsin where Dr. Jamie Thompson has led great efforts in stem cell research.
Mr. JACKSON LEE. You might include them in your answer. My question really goes to the point, the broader point, that I come from a community where the Texas Medical Center is and several medical schools; would you view legislation like this permeating the research that is done in those institutions, in light of the sensitivity that I imagine physicians have who are not lawyers, in not wanting to have their lab criminalized?
Ms. SHAPIRO. Absolutely. Without any legislation, and I can speak about the experience we are going through at the moment at the Medical College of Wisconsin, there is tremendous caution in going into this sort of research simply because of the important ethical issues involved. But, with any sort of a criminal statute, I can tell you that they would run the other way as far as they could.
Mr. JACKSON LEE. Let me raise this question for all of you, and I'm going to refer you toif you have in front of youbut if the Chairman would indulge me, it is the definition section of the legislation that I think we are presently looking at, H.R. 1644, human cloning. Let me just quickly go over it. Human cloning means human asexual reproduction, accomplished by introducing the nuclear material of a human somatic cell into a fertilized or unfertilized oocyte whose nucleus has been removed or inactivated to produce a living organism in any stage of development with a human or predominately human constitution. I'm not sure if this has been amended. I know we have not marked it up and forgive me for reading so quickly, but I would appreciate Dr. Kass, Dr. Callahan, Dr. Prentice and Dr. Shapiroas I read it as a lawyer, engaged only in this ethically, and not from the perspective of being in a lab, this is enormously broad.
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Mr. SMITH. Ms. Jackson Lee, let me interrupt you just for a minute. I would like you to get a brief response from one individual, but actually our second hearing is going to be on the legislation itself. So, there will be more opportunity to question the legislation.
Mr. JACKSON LEE. I'll take a first answer. Would you mind if Dr. Kass and Dr. Shapiro, and I will not have the other
Mr. SMITH. If you all would briefly reply.
Mr. JACKSON LEE. Thank you, Mr. Chairman.
Dr. KASS. I think this is very narrow, especially when read with the other section, which indicates what is does not cover. This is very, very precise. I think everybody would understand what this means.
Mr. JACKSON LEE. You think it's narrow.
Ms. SHAPIRO. I don't think so. I have to tell you, I have not yet read this, so, I don't know where the definition or how the definition is being used in the bill, but it seems broad to me.
Page 87 PREV PAGE TOP OF DOC Segment 1 Of 2 Mr. JACKSON LEE. Thank you very much, Mr. Chairman.
Mr. SMITH. Thank you, Ms. Jackson Lee. The gentleman from Florida, Mr. Keller, is recognized for his questions.
Mr. KELLER. Thank you, Mr. Chairman. Let me just say, Dr. Shapiro, like you and many others here, I also am a lawyer by trade and, unfortunately, there are some folks that say we are a good example of why human cloning is a bad idea.
Let me begin by asking you, Dr. Kass, a question. Some people will argue or say that cloning is really not morally different from in vitro fertilization, and I suspect you have a different view. What is your thought on that?
Dr. KASS. No, I do have a different view. I think cloning is in some respects continuous, but in the decisive respect something radically different. In in vitro fertilization, the egg and sperm come together by the usual sexual activity of chance. There's a chance meeting of and egg and a sperm and the individual that is produced is the product of that chance union. In the case of cloning, deliberate efforts are made to produce an individual who is genetically identical or virtually identical, not just to some contemporary, but to an individual who already exists and, in fact, who could have existed and is now deceased. In this respect, cloning is the first of a foreseeable group of technologies that will enable us to control, not just whether a child is born, but precisely what the genetic constitution of that child is.
Mr. KELLER. Okay. Dr. Prentice, what is the gist again and the difference between reproductive cloning and what they call therapeutic cloning?
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Mr. PRENTICE. Congressman, essentially the idea behind reproductive cloning would be to clone the individual and actually bring them to a live birth. Therapeutic cloning, frankly, the intent is not to bring them to a live birth, but at a very early embryonic stage, approximately five to 9 daysat that point we look like a hollow ball with some cells insideis to harvest those cells from the inside, the embryonic stem cells, and in doing so you do have to destroy the embryo to put those cells in the culture.
Mr. KELLER. Okay. It is my understanding from some of your previous writings that of the mammals cloned so far, approximately 95 to 99 percent do not survive. Would you anticipate a similar failure rate on attempts to clone humans?
Mr. PRENTICE. Definitely so. Now, obviously, techniques can improve, but there's so much unknown at this point in terms of the whole cloning procedure. It sounds very simple on paper or drawn on the board, but we do not know too much about what actually goes on in terms of reprogramming that nucleus which is inserted into that oocyte, and that appears to be, at least to a large extent, what gives us the problems with many of the clones not even making it to term, and virtually all of them not surviving even after term. The possibility could be genetic problems that develop in terms of this technique.
Mr. KELLER. Thank you, Dr. Prentice. Mr. Chairman, I'll yield back the balance of my time.
Mr. SMITH. Thank you, Mr. Keller. What was the last question you had, Mr. Keller?
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Mr. KELLER. The last questionI asked him the difference between therapeutic cloning and reproductive cloning.
Mr. SMITH. Thank you. The gentleman from Virginia, Mr. Scott, is recognized for his questions.
Mr. SCOTT. Thank you. On this morning's radio, I heard a piece on the cell research to help hemophiliacs. They would take a piece of skin, do something with it in the lab, and it would produce Factor VIII. That is about all I remember about it, and that would help blood-clotting for hemophiliacs. Would any of the legislation in this area affect that kind of research?
Mr. PRENTICE. No, sir, it actually would not. The bill which I have seen, I think is very carefully crafted, very tight. The type of research you are discussing is covered under this section, which talks about no prohibition for the use of nuclear transfer or other cloning techniques to produce molecules, including the Factor VIII clotting factor, DNA, cells other than human embryos, tissues, organs, plants or animals other than humans. In my reading of this, this has no chilling effect on medically necessary research. It only prohibits the actual production by this cloning technique of a human individual.
Mr. SCOTT. Would the violations start with the implantation or would it start earlier?
Mr. PRENTICE. I guess I will take that one, too. My assumption in reading this is that the violation would start at the point where the nucleus was inserted into that enucleated oocyte. At that point, you have the clone. The problem, again, in terms of distinguishing between reproductive and therapeutic cloning is, if you were to take an embryo produced by reproductive cloning, therapeutic cloning, in vitro fertilization and put them under a microscope, you could not distinguish how that embryo was produced. So, as my colleague referred to earlier, there is no way we can judge intent. It could be that we might clone an individual, clone an embryo, and the original intent could have been for therapeutic cloning, deriving the embryonic stem cells, but, if we put some of those excess embryos in the freezer and take them out, how are we going to judge whether that was an IVF embryo put in there, one that was going to be used for reproductive cloning or one that might be used for therapeutic cloning? There is no real way to tell the difference.
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Mr. SCOTT. Therefore, your suggestion is not to have any therapeutic cloning?
Mr. PRENTICE. Yes, sir, that's it. I think we should follow the Brownback-Weldon bill and totally ban human cloning.
Mr. SCOTT. Did somebody else want to comment on whether that would be a good thing or bad thing, to prohibit all therapeutic cloning, Dr. Kass?
Dr. KASS. Yes, I would like to comment. Dr. Prentice and others have indicated that, to our great amazement, the work with stem cells derived from adults, from cord blood, is providing us with the kinds of tissues we need to do exactly this kind of therapy. We have a morally unproblematic alternative to the so-called therapeutic cloning. That would be the first point, so I do not think there is a great deal we are losing if we give this up.
Second, if you're serious, really serious about trying to prevent so-called reproductive cloning, that is, the birth of cloned children, I don't think you can actually make that ban effective unless you ban that process at the beginning. Once the embryos are there, you are not going to be able to control what is done with them. We have learned that with the so-called spare embryos to this point.
Mr. SCOTT. Let me ask you a practical question. If we create a criminal statute prohibiting therapeutic cloning, all kinds of cloning, that criminal statute would only have an effect within the jurisdiction of the United States?
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Dr. KASS. Actually, sir, we are behind the curve on this one. Many, many nationsthe Council of Europe has called for this. The U.N. has called for a ban on this and on germ line modification, and it seems to me they look upon us as being something of a rogue nation in this way. I would not call this a ban on therapeutic cloning. I think what one wants to say is this is a ban on the cloning of human beings in the most effective way possible, and I think the bill is carefully drawn and could be made effective and would not chill the other necessary and desirable, medically beneficial and therapeutic research.
Mr. SCOTT. Is your testimony that if we passed a criminal statute, there would be nowhere that the research would move to totally unregulated, without any oversight at all, and whether that would be better or worse than trying to regulate it the best we could in the United States?
Dr. KASS. Well, for most things, I am not in favor of legal bans. Bans are a blunt instrument, and you cannot preventyou do not prevent all cases of incest by laws against incest and we do not prevent the buying and selling of organs for transportation in other parts of the world, but we have made this a crime in the United States and it has been enforced. So, I don't say we are going to absolutely prevent this, but if we are serious about trying to do something, this is our best shot. In collaboration with other nations I think we have a fighting chance to make sure that it doesn't happen or doesn't happen much. I don't think you can do better with law.
Mr. SCOTT. Ms. Shapiro, did you want to respond?
Page 92 PREV PAGE TOP OF DOC Segment 1 Of 2 Ms. SHAPIRO. I'm not a doctor. However, what I read is that 1 day the literature may suggest that adult stem cells are going to be equally as promising as embryonic stem cells and the next day that is controverted. That is the point. If we snuff out the ability to do this research, we may never know. I do not think that it is as easy from what I read, and again, with all the disclaimers I put on the table before, to simply say we will be losing nothing if we prohibit this sort of research from going forward.
Mr. SMITH. Thank you, Mr. Scott, and also I would like to thank all of the witnesses today for their expert testimony, even if they are lawyers, and it is much appreciated and very helpful and useful. Also, I will let you know as well as the audience know that the second hearing on human cloning is scheduled for June 19th. That is a Tuesday, at 4 in the afternoon, and the subject of that hearing will be more the Federal regulation of human cloning; and also we will be talking about, certainly, Dr. Weldon of Florida's bill that has been introduced and perhaps Mr. Greenwood of Pennsylvania's bill if it has been introduced at that time. Thank you again for your testimony. The gentlewoman from Texas has a comment.
Mr. JACKSON LEE. Mr. Chairman, may I submit a question for the witnesses to respond to in writing?
Mr. SMITH. Absolutely. Without objection, anyone who has written questions can submit them and we will hope for answers within 2 weeks if you can accommodate us on that score, as well.
Mr. SCOTT. Mr. Chairman, I ask unanimous consent to include this statement in the record.
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Mr. SMITH. Without objection, Mr. Scott, we will make a part of the record your opening statement.
Mr. JACKSON LEE. I'm sorry. Likewise, if I may.
Mr. SMITH. All Members are welcome and without objection, will be allowed to make their full opening statements a part of the record.
Mr. JACKSON LEE. Mr. Chairman, simply, I will not give the question, but it regards the impact of this legislation on in vitro fertilization and the embryo. Thank you.
Mr. SMITH. Thank you, Ms. Jackson Lee. Thank you again to all of our witnesses. We appreciate your being here and the hearing stands adjourned.
[Whereupon, at 12:03 p.m., the Subcommittee was adjourned.]
Next Hearing Segment(2)
(Footnote 1 return)
Leon R. Kass, M.D., Ph.D. is the Addie Clark Harding Professor, The Committee on Social Thought and the College, The University of Chicago, and co-author (with James Q. Wilson) of The Ethics of Human Cloning. Mailing Address: The University of Chicago, 1116 E. 59th Street, Chicago, IL 60637. Telephone number: 7737028571. E-address: <firstname.lastname@example.org>.
(Footnote 2 return)
Some have argued that the First Amendment right to free speech encompasses the right of scientific inquiry. In Branzburg v. Hayes, 408 U.S. 665, 705 (1972), the United States Supreme Court specifically analogized the information function performed by academic researchers to that performed by the press; and in Meyer v. Nebraska, 262 U.S. 390 (1923), the Supreme Court stated that 14th Amendment liberty rights encompass freedom to ''acquire useful knowledgeand generally to enjoy those privileges long recognized at common law as essential to the orderly pursuit of happiness by free men.''
(Footnote 3 return)
Cal. Bus. & Prof. Code §2260.5