TYPE: COMMITTEE HEARING

LENGTH: 19240 words

COMMITTEE: EDUCATION, LABOR AND PENSIONS COMMITTEE

SUBCOMMITTEE: SENATE HEALTH

HEADLINE: U.S. SENATOR EDWARD KENNEDY (D-MA) HOLDS HEARING ON CLONING

SPEAKER:
U.S. SENATOR EDWARD KENNEDY (D-MA), CHAIRMAN

LOCATION: WASHINGTON, D.C.

WITNESSES:

U.S. SENATOR ARLEN SPECTER (R-PA)
CHRISTOPHER REEVE, FOUNDER, CHRISTOPHER REEVE PARALYSIS FOUNDATION
PAUL BERG, STANFORD UNIVERSITY MEDICAL SCHOOL
THOMAS MURRAY, PRESIDENT, THE HASTINGS CENTER
JUDY NORSIGIAN, FOUNDER, BOSTON WOMEN'S HEALTH BOOK COLLECTIVE
STUART NEWMAN, NEW YORK MEDICAL COLLEGE

BODY:

 
U.S. SENATE HEALTH, EDUCATION, LABOR AND PENSIONS COMMITTEE
HOLD HEARING ON HUMAN CLONING
 
MARCH 5, 2002
 
SPEAKERS:
U.S. SENATOR EDWARD M. KENNEDY (D-MA)
CHAIRMAN
U.S. SENATOR CHRISTOPHER J. DODD (D-CT)
U.S. SENATOR TOM HARKIN (D-IA)
U.S. SENATOR BARBARA A. MIKULSKI (D-MD)
U.S. SENATOR JAMES JEFFORDS (I-VT)
U.S. SENATOR JEFF BINGAMAN (D-NM)
U.S. SENATOR PAUL DAVID WELLSTONE (D-MN)
U.S. SENATOR PATTY MURRAY (D-WA)
U.S. SENATOR JACK REED (D-RI)
U.S. SENATOR JOHN EDWARDS (D-NC)
U.S. SENATOR HILLARY RODHAM CLINTON (D-NY)
 
U.S. SENATOR JUDD GREGG (R-NH)
RANKING MEMBER
U.S. SENATOR WILLIAM FRIST (R-TN)
U.S. SENATOR MIKE ENZI (R-WY)
U.S. SENATOR TIM HUTCHINSON (R-AR)
U.S. SENATOR JOHN WARNER (R-VA)
U.S. SENATOR CHRISTOPHER BOND (R-MO)
U.S. SENATOR PAT ROBERTS (R-KS)
U.S. SENATOR SUSAN COLLINS (R-ME)
U.S. SENATOR JEFF SESSIONS (R-AL)
U.S. SENATOR MIKE DEWINE (R-OH)
 


*


KENNEDY: If we could have everyone's attention please. We've got a very important hearing today with some extraordinary individuals who want to speak about a matter of core importance to the kind of country we can become with the type of research that's being considered, and we want to hear from them, and we have some very, very special witnesses.

The way that we will proceed is, I will make an opening statement. Hopefully my colleague, Senator Collins, is here, and we're going to be joined by others. I hope we can keep the statements of those of us on this side of the aisle, and all of us here to a minimum so that we can spend maximum time listening to Christopher Reeve and our other outstanding panelists. But I notice that we'll start off, I will say a brief word about today's hearing. Today, we'll explore the extraordinary new field of regenerative medicine, and with this promising therapy, the cure for diseases that have afflicted millions of Americans for generations, is now within our grasp in our lifetimes, diseases that deprive people of their dignity, their careers, their ability to recognize even their own children, even their very lives. I believe that we owe it to our fellow citizens to do everything we can to encourage this extraordinary medical progress that brings such great hope to so many.

We'll also hear today about the dangers of cloning a human being. We'll learn that there are deep-seated moral and ethical objections to ever cloning a human child. I share these profound objections to cloning. Senator Feinstein and I have introduced a bill to make such cloning illegal. Senator Harkin, Senator Specter, Congressman Campbell, have introduced similar legislation, and many members of our committee have co-sponsored these bills.

But we must not confuse human cloning with regenerative medicine. One creates a person, and should be banned. The other provides a cure and deserves our strong support. Regenerative medicine involves transferring the genetic material from one human cell into another human cell in a laboratory dish. It does not involve reproducing a child or creating carbon copies of ourselves.

In our opposition to human cloning, we must not make the grave mistake of denying the patients the hope that regenerative medicine brings. Enacting sweeping bans on that type of research would delay the cures that are so urgently needed by patients in every community in America.

Many of us listened with close attention to the hearing on stem cells, held in this committee last September. We heard that stem cells can serve as powerful healers for the human body. These extraordinary cells can generate a new heart muscle for those who have suffered cardiac damage, and new pancreas cells for diabetics, new brain cells for those with Parkinson's Disease.

But a shadow looms over this research. A patient's body may reject the very cells intended to provide a cure. To unlock the potential of stem cell research, doctors are trying to reprogram stem cells with the patient's own genetic material. Using breakthrough technique of nuclear transfer, each one of us could receive transplants or new cells perfectly matched to our own bodies. That is why this research is so important.

New science always brings new challenges and new debates, but we have proven in recent years that we can balance the promise of science with the ethical demands of our society. Some have said that this research will put women at risk by subjecting them to undue pressures to donate eggs. Our legislation addresses this concern by applying to all nuclear transfer research the same strict, ethical standards used in research funded by the Federal Government. Many organizations representing women around the nation, strongly reject any prohibitions on this important research.

I received a letter yesterday from the National Partnership for Women and Families, the American Association of University Women, the American College of Obstetricians, and Gynecologists, the Society for Women's Health Research. Far from wanting curbs on this research, they regard it as essential to ensuring the health of women.

They write that: "Nuclear transfer research offers hope to women struggling to care for parents with Alzheimer's Disease or suffering after a stroke, children with juvenile diabetes, and husbands with heart disease. In our pursuit of better information, treatment and cures for women and their families, we must insure that the newest and most promising techniques are available."

In this committee 25 years ago, we held hearings on whether to ban the basic techniques of biotechnology. Time after time, we heard of the medical advances that this new field of research would bring. Then, as now, some dismissed this promise as a pipe dream, urged Congress to prevent this new field of biotechnology because it seemed new or strange.

Congress rightfully rejected those arguments, and today patients across America enjoy breakthrough new biotechnology products that help dissolve clots in the arteries of stroke victims, fight leukemia, and help those with crippling arthritis lead active lives. All of this would have been lost if Congress had banned the basic research in the 1970s.

During our previous debate in 1998, the Senate rejected legislation that would have enacted sweeping bans on vital, medical research. Congress was right to defeat unwarranted restrictions on lifesaving research in the past, and we should reject a ban on regenerative medicine now. We should make sure that the research is done ethically, with appropriate oversight so that women who donate eggs are informed of the risk, the nature of the research in which they are participating.

Science should always move forward, hand in hand with ethics, but to deny the patients the new medical miracles that come from research and regenerative medicine, would be to deny lifesaving cures for future generations. Senator Gregg.

GREGG: Mr. Chairman, I appreciate the chairman holding this hearing on the issue of cloning, and specifically the ethical questions which are raised by the issue. This is not a hearing on the basic issue of embryonic stem cell activity, which we've had other hearings on, and which there's a great deal of work being done on in which my colleague to the right is the expert on in Congress.

This goes rather to the issue of cloning humans, human embryos, and whether that's ethical or whether it's even scientifically practical. The United States grew out of the Judeo-Christian ethic, which gives incredible import to life. Our culture is built on that concept. It is one of the reasons why we are held out as a beacon across the world, and the issue of cloning humans goes to some of the most fundamental concerns that involve our culture.

The idea that you would use science for the purpose of producing a human being to specifications, which a scientist may want, or a parent may want, or a researcher may want, obviously flies in the face of some fundamental beliefs of our society. Human engineering using cloning is something we fought a war about as a society, when there was a culture, which demanded or desired to produce an alien race that it deemed to be superior.

The fact is that cloning humans is wrong. The question for us as a Congress is whether there is some intermediate step that can be taken when you start to clone an embryo, which by definition becomes a human when it grows, if there is some intermediate step that can be taken, which does not lead us down the slippery slope to pursuing genetic engineering and the perfection of the race pursuant to scientific or arbitrary demands of individuals. I'm not sure there is. I'm not sure that once you clone an embryo that there is anyway to assure that you aren't clearly on the path towards developing an engineered human being, which would be such an affront to our Judeo- Christian ethic.

What these hearings are about, of course, is to determine whether that's possible, or whether it's even appropriate. And so, I will listen, but my view is that this is not embryonic research, which has huge potential obviously, and which has the distinct possibility of creating tremendous benefits to people who have certain diseases. But this is about engineering humans. Cloning is about engineering humans, and that is fundamentally wrong. So, let us proceed with the hearing and see where we go.

KENNEDY: We were going to have just the chairman and the ranking member, but we always benefit from hearing from Dr. Frist, and I know this is a matter that he's very engaged in, and then maybe I'll ask if Senator Dodd wanted to make a brief comment, and then we'll get on with our witnesses.

FRIST: Thank you, Mr. Chairman. I'll be brief and we'll put a more extended statement in the record, and I do want to thank you and the ranking member for this hearing.

FRIST: We last talked about human cloning in this committee. It's been five years and a lot, as we'll hear about today from our excellent panel of witnesses, a lot has happened since that point in time, and one of the realities are that science is moving at breakneck speed, which puts an increasing responsibility on us in this committee as we approach these issues that sit at the heart of this intersection of science, of advances in technology, of medical advances, with the ethical issues, the moral issues, and that intersection is something we have a responsibility to address and continue to address in as sophisticated a way as we might possibly can.

It was just last year that we did face the whole issue of stem cell research, and whether or not federal funds should be used for stem cell research. I, as many of my colleagues know, am a strong advocate for stem cell research, including embryonic stem cell research. We'll hear some about the promise, which is tremendous, the hope that it brings to people who suffer from the range of illnesses and diseases that we know are with us today, whether it's spinal cord disease or Alzheimer's or leukemia or heart disease or many other debilitating and chronic conditions.

But we can't divorce this discussion from the ethical and the moral challenges. I do applaud President Bush's decision in August to open up the embryonic stem cell research, and we'll probably review a little bit about that today, in terms of the progress that can be made based on those principles.

But I do want to emphasize, and will continue to emphasize, that we've got to proceed cautiously. We've got to proceed carefully. We've got to do so within a cohesive framework that promotes scientific progress, but also insures, as Senator Kennedy mentioned, continuous oversight and sensitivity to the science yes, but also to the moral considerations, to those ethical considerations, to those religious implications that this research by definition will introduce, because it does touch, it does touch the earliest stages of human life.

Wherever you define life or human beings, it is a continuum and we're dealing at the earliest states, yes at the cellular level of human life. There are really two overarching questions that I hope that we address in the hearing today. It really comes down to, how do we balance these tensions between the scientific pursuit, which is a real driving force, and appropriately so in terms of creativity, science, pursuit of knowledge, but how do we balance that with these moral and ethical and out of that spiritual and religious principles?

And then what if, and we'll talk about that, what if this science is just so promising in terms of future cures, and we'll hear about that, and I don't want to jump to conclusions right now? But, the fact that it offers great promise, how does that shift the overall ethical and moral framework, or should it push the limits a little bit more? And, that's something we've got to talk about, especially if we're going to be legislating prohibitions and bans.

I think it is critical, and I'm very hopeful, Mr. Chairman, that we can leave the hearing with an understanding of the difference between stem cells and cloning, because there are - it's hard for me to explain and I lived with it in the field of transplantation and bone marrow transplantation is a model for much of what we talk about.

But I do hope that we can get a better understanding in the hearings of the difference between stem cell, stem cell research, and again I'm a strong advocate for that, and cloning. They're different. They have interrelationships that we need to understand before we engage in over-legislating as we go forward.

I think we're going to end up at the end of the hearing, not jumping ahead, of sort of a broad consensus that reproductive cloning is not a direction that any of us want to go in today because of the potential for harm. The unknown is there. The whole concept of being able to address the sort or engineering of human beings, we're not ready for as a society, and the science itself is not ready for it today.

The ethical considerations today for research and type cloning, I think very much will stem around the questions of the fact that we create living, something new and living, earliest stages of life, but in order for the science to take place, these experiments to be conducted, we have to destroy that entity however you define that, and that very much is the center of the ethical considerations.

With that, Mr. Chairman, I look forward to hearing from our witnesses today as we address and hopefully learn a lot more about these issues.

KENNEDY: Ask if Senator Dodd...

DODD: I'd ask consent, Mr. Chairman, to include a statement in the record and so we get to our witnesses here. I think Bill Frist has offered a very sort of good sense of balance of what all of us are wrestling with here. Maybe it just needs to be said, because too often as you engage in this, there are people who draw conclusions.

If you begin to talk about the benefits of this new science that's developing, people immediately assume that you've drawn some moral lines or arrived at some ethical considerations, and for my own part, I happen to believe that the very idea of creating a clone of a human being is chilling, and I think it is to most people, if not all on these committees that we're dealing with here. And, the obvious medical dangers are there, but beyond the medical dangers, I think it's morally irresponsible to be talking about it, and that probably has to be stated over and over again.

They challenge our very fundamental concepts about the unique nature of every individual, and I for one would not want to be supportive of a proposal that would allow or tolerate that to go forward. The creation of life through scientific experimentation is ethically and morally unacceptable to this individual.

Having said that, I also would tell you that the opportunities for making a difference are life-affirming actions. Johns Hopkins recently announced that they were able to restore motion to paralyzed rodents by implanting embryonic stem cells in their spinal cords. Israeli scientists turned human embryonic stem cells into insulin producing cells, and while this is certainly early development, just imagine what that could mean, just imagine what that could mean to the fight against juvenile diabetes, something that every one of us certainly have constituents or friends or families that are affected by that.

I just would mention, Mr. Chairman, a letter from a family in my own home town in Connecticut, just a couple of thoughts on it. The daughter has Type I Diabetes and spends her life connected to an insulin pump, and her father wrote me and urged us not to restrict research involving therapeutic cloning.

And the letter reads, I'll just quote it: "The men and women and children who are suffering from life-threatening diseases are in a race against time. It is our responsibility to make sure they benefit as quickly as possible from the very best that science and technology can offer."

I think those sentiments are again a reflection of how many of us feel on this committee. So, Mr. Chairman, I thank you immensely for doing this. There are many things that Congress does that people can raise the issue whether or not it's time well spent. I can't think of a more important subject matter that we'll be hearing about today from our witnesses, and discussing on the one you've convened us for, and I thank you immensely for that.

KENNEDY: Thank you very much. We are joined for some comments by Senator Arlen Specter, who is an expert on this subject. He and Senator Harkin have conducted extensive hearings in the Appropriations Committee, and we look forward to hearing from him.

Senator Landrieu is a leader in the Congress on women's issues, and has had a special interest in this. She's very concerned about women's health issues, and as always, worked closely with our committee in helping us understand some of these issues more closely.

So we'll hear from both of them. We're hopeful that they'll be able to summarize their comments, so we can give full time to really an outstanding group of witnesses who have come, but we're very glad to have you here.

Senator Specter?

SPECTER: Thank you very much, Mr. Chairman. A lengthy statement I've asked be introduced into the record, and I shall be brief here. There is a very distinguished group of scientific experts waiting to testify. I appreciate the opportunity to appear before this committee to essentially inform you what we have found in 12 hearings in the Appropriations Subcommittee, which has the collateral responsibility, which this authorizing committee does.

The benefits from stem cell research were examined by our subcommittee a few weeks after they came upon the same in November of 1998, and we have heard detailed scientific testimony about marvelous advances on Alzheimer's, Parkinson's, curable perhaps within five years, heart disease, spinal cord injury, cancer. The scientific experts tell us that 170,000 Americans a year might be spared disease- related deaths through stem cell therapies.

Now we face a vote in the next several weeks in the Senate on legislation passed by the House to ban so-called therapeutic cloning. Regrettably, the scientists gave it a misnomer. It's not cloning. Cloning is reproductive cloning to create another person, and that we all abhor and reject, and ought to legislate against. But the so- called therapeutic cloning involves illustratively taking a cell from a person who has Parkinson's, and putting that in the donated egg, and then the stem cells, which come out, can be used to treat the Parkinson's without being rejected.

We need to inform the American people just what this means, and if Americans understood what was involved here and there was legislation, which tied the hands of the scientists, I think there would be an enormous public outcry of rejection, that in effect, we would be going back to the dark ages. And the people who suffer from these ailments, and we had a mini hearing a few minutes ago in the outer lobby, with Christopher Reeves testifying about what it could mean for spinal cord injury. The people who have them, expect to be benefited by what science can provide.

The history of rejection of science is grotesque. In 1846, a committee of the Spanish government said Columbus shouldn't be financed because there's no point in looking beyond the flat Earth. Galileo was imprisoned for support of Copernicus' theory that planets revolved around the sun. Pope Boniface VIII banned the practice of cadaver dissection in the 1200s and set back medical research some 300 years. In 1847, the Scottish Calvinist Church prevented the use of anesthesia in childbirth, saying it was "pain of childbirth was God's will." And the House of Commons rejected Edison's use of electricity, or his theory to promote electricity.

Those are but a handful of legislative efforts to tie the hands of the scientists, and it would be grotesque, in my opinion, if we were to enact legislation, which the House has passed, which would prevent this fundamental medical procedure of taking a cell from a person and putting it in an egg and using the stem cells to cure cancer or heart disease or Parkinson's or delay Alzheimer's. And, I believe that hearings like this have to be amplified, and we have to find a way to take this message to the American people, to inform their Senators not to confirm the House bill. I yield back the balance of my time, Mr. Chairman.

KENNEDY: Senator Landrieu, we appreciate it.

LANDRIEU: Thank you, Mr. Chairman. Let me begin by saying that I commend you for calling this very important hearing, and have the greatest respect for you and the members of this committee, that have dealt with these and many, many difficult issues for many, many years and helped give great guidance to our country and to the world, and I want to say that I have the greatest respect for all those gathered here today, some of the finest scientists literally in the world and some concerned, very concerned individuals that have a direct - will be directly affected by the outcome.

Let me be brief. I have a statement for the record, but I would like to summarize my remarks before you today. The answer to the moral and ethical questions raised by this debate on human cloning, reproductive and therapeutic, in my opinion, Mr. Chairman, are far too serious to be ignored, and far too dangerous to be constrained by regulation alone, as some who are opposing the Brownback-Landrieu legislation would suggest. For this reason, I am very happy and proud to stand with my colleague and others, which makes all form of human cloning illegal, and creates strict penalties for those who would violate this stand.

Over the past several weeks, there has been a great movement towards this position from the political right, from the political left, and from many in the center and there are many reasons for this, and the reasons are very varied, but the conclusion and the overriding principle, Mr. Chairman, is the same, and that is that creating human life simply for the purpose of destroying is, is immoral, it's unethical, and it should be illegal.

LANDRIEU: At the turn of the century, a French philosopher Francois Lavoisier (ph) said, "Science without conscience is the ruin of the soul." I think that these simple words capture for us the very essence of this debate of human cloning.

Since the days of Hypocrites society has struggled to maintain a balance between realizing the potential of scientific discovery and the moral and ethical questions that such discovery raise. Each and every time that we're able to move forward in our fight against disease and death, we have to ask ourselves, does the potential that this treatment or research offer outweigh the inherent moral and ethical risk it creates? In some cases, that answer has been yes and in other cases the answer has been no.

Procreation is a process designed to fully resolve in a fully functioning human being. Through in vitro fertilization, science has had the astounding privilege of assisting in this process, but all the while with the ultimate goal of reproduction. The human body is not a product to be mass-produced, stripped for parts, even in the earliest stages of development. Assembly lines, patents, and warehouses are appropriate terms when talking about cars and computers, but not people. The National Conference of Catholic Bishops I think have so aptly stated: "We must be sure not to undermine human dignity in the pursuit of human progress."

Secondly, since at the present this process requires a human egg, this "industry" would rely on women as their major suppliers. In this brave new world, women's eggs and wombs would be commodities, potentially sold to the highest bidder. Moreover, women whose eggs are harvested for these purposes are treated with hormones to induce super ovulation, possibly putting their health at risk for financial gain. The exploitation of women in this process, I believe, is inevitable. A complete ban on human cloning is the only way to preserve the dignity of women and protect them from being exploited.

While the bill bans human cloning, I want to say that it redirects science to other alternatives that offer extremely promising therapies, that human cloning in addition to - that offers very promising technologies, even exceeding those therapies of human cloning.

Let me be clear, the Brownback-Landrieu Bill is carefully drafted and limited in scope so as to only prohibit human cloning. Our bill makes it very clear that there's to be no interference with scientifically beneficial practices of animal cloning, cloning of human DNA fragments, the duplication of somatic cells as stem cells and tissue culture.

I would even say for the record, Mr. Chairman, that you know that I support stem cell research. Senator Brownback has a different position. But this is a different issue. I support stem cell research. I support research on embryonic stem cells that are in excess from in vitro processes, which hold very promising therapies, and I'd like to submit for the record a list of research that our bill will not prohibit.

Finally let me say, the only way to effectively insure that a human being is not cloned is to stop the process from the very beginning; that is, to say we must ban it. Effectively, we need to ban all human cloning, and let me just give you an analogy. Because we've determined as a Congress that narcotics is not appropriate and is illegal and is not right, are we then the manufacturer of it and the distribution of it and the use of it? It would be like us allowing for the manufacture of drugs, the distribution of drugs, but outlawing the use of drugs. It's very difficult once you start down this path to draw a line, if you don't draw the line in the beginning, and that's what the Brownback-Landrieu Bill does.

And finally, let me say, just because proponents of human cloning have used one argument, well a scientist is going to do it. Let's just let them go ahead and do it, we should just give up the ban and let science march on. Just because someone will violate a law doesn't mean that we can't have laws on the books when there are ethical and moral considerations of this great dimension.

Justice Kennedy once said: "The law is not a set of rules, but it is a set of promises, promises we make to one another as mankind." I believe, Mr. Chairman, this is a promise worth making to our society and our children today. I respect those that differ, but I feel very strongly that this is the right way to go. Thank you.

KENNEDY: Thank you very much, Senator Landrieu. I want to just, since this point was so important, mention that in the legislation which Senator Feinstein and I are supporting applies the same ethical guidelines. This research, which is used at the NIH research. It's all nuclear transfer research and central to these protections as the right of informed consent.

We require all women who consider donating eggs be fully informed of the risk, and the research would be allowed only if women freely consent to donate knowing the risks as well as the benefits and require that all research must be reviewed by an institutional review board.

This ethical review is the backbone of the system of protections that have protected research subjects in all federally funded research for a generation, to be sure that women are protected from improper pressure to donate. The institutional review boards must reject any research where improper pressure has been applied, and we protect the privacy of donors, which is a key aspect of medical research. It may be not strong enough.

We'd welcome any other suggestions that you have, but I wanted to at least mention that at this time. I thank you very much. I take your message very, very seriously. We appreciate it.

LANDRIEU: Thank you. Mr. Chairman, let me say, no one has been a stronger advocate for women and women's health and women's rights, and so I really appreciate the language that you've put in your bill and think it is very extensive. But the basis of this bill is frankly that human life should not be created for the purpose of therapeutic methods or destruction, and that is really the simple underlying essence. Dr. Frist can give us a lot more details regarding the medical technologies, but that is really the basis of our bill, as well as the opportunities for exploitation no matter how tight we write those regulations.

KENNEDY: Thank you very much.

LANDRIEU: Thank you, Mr. Chairman.

KENNEDY: We'll proceed to our first panel. We've been joined by Senator Harkin. We mentioned, Senator Harkin, you and Senator Specter have had extensive hearings on this. We're about to hear from our outstanding panelists, but if you wanted to say a brief word, we'd welcome any comment that you'd make.

HARKIN: No, thank you very much, Mr. Chairman. No, I would not interfere at this point, just thank you for having this very vital and very important hearing.

KENNEDY: Thank you for the sense of work that you've done.

HARKIN: Thank you, Mr. Chairman, for what you're doing.

KENNEDY: We'll look forward to working closely with you. We are privileged, welcome today to have really an outstanding group of experts for the committee. And first of all, I'd like to welcome Christopher Reeve to our hearing this morning. I think for all Americans, his abilities have made him an extraordinary successful actor, but as I've said at other times, his courage has made him an American hero, and we're enormously appreciative of his willingness to come to this committee.

He's been a tireless advocate, a man of extraordinary courage, and he lets all of us know that you don't have to be a Senator to make a big difference in life. All you have to do is have the courage of Christopher Reeve. We welcome you here to our committee, and we're going to look forward to having you lead off the discussion.

We'll have Dr. Paul Berg. He's one of America's foremost medical researchers, currently the Cahill (ph) professor of cancer research at Stanford University. His fundamental discoveries in genetic research paved the way for countless new medications developed by the biotech industry. Dr. Berg's contribution to medical progress has been recognized by numerous awards, including a Nobel prize in 1980.

Tom Murray, Doctor Murray has devoted his career to providing ethical guidance for new developments in medicine. He is currently the president of Hastings Center, one of the leading institutes for medical ethics in the United States. Doctor Murray was appointed by President Clinton to serve on the National Bioethics Advisory Commission. He's also served on the Ethics Committee, American College of Obstetrics and Gynecology, and on the Ethics Board of the Human Genome Organization. We welcome you.

Ms. Judy Norsigian is a founding member of the Boston Women's Health Book Collective, publishers of "Our Bodies, Ourselves" series of books. She's a dedicated advocate for women's health issues. She'll describe to the committee her concerns about cloning. I want to extend a very warm, personal welcome.

NORSIGIAN: Thank you, Senator.

KENNEDY: To someone that is highly regarded and respected in our home community. Dr. Stuart Newman is a professor of cell biology and anatomy at the New York Medical College, (inaudible) New York, conducts research in developmental biology. Dr. Newman has written extensively about concerns about the biotechnology industry and new developments in genetic research.

We want to thank you so much for being here, Mr. Reeve, and we look forward to hearing from you.

REEVE: Thank you very much, Senator Kennedy, and members of the committee. Thank you for this opportunity to testify this afternoon.

For the record, I'm C2 ventilator-dependent quadriplegic, and that means that I am paralyzed from the shoulders down and unable to breathe on my own for the last seven years. I have not been able to eat, wash, go to the bathroom, or get dressed by myself.

Now some people are able to accept living with a severe disability. I am not one of them, and that is why I have a keen interest in research and I'm deeply disturbed by unreasonable attempts to block scientific progress. The fact that the House of Representatives banned cloning last year without careful deliberation makes the Senate today a matter of great urgency.

Now because Senator Brownback has introduced a Senate version of the House bill, I wish to comment on some of his public statements. He has characterized embryonic stem cell research as immoral and unnecessary, but in testimony before the (inaudible) subcommittee, on January 24th of this year, he stated that he supports in vitro (inaudible).

And when Senator Harkin asked if he was aware that the majority of excess fertilized embryos are routinely thrown into the garbage, his response was, "I think most of them are put up for adoption." That is simply not true, and in a recent interview, Senator Brownback said he wants to cure ALS, and he added: "If we pursue the adult stem cell area, where we all agree that we can do this, then that's the right thing to do." Again, that's not true.

Experts in ALS research believe that embryonic stem cells are the best and possibly the only hope for victims of that fatal condition. Now today, 100 million Americans suffer from serious or chronic incurable diseases. Fifty-four million Americans are disabled. Our government's supposed to do the greatest good for the greatest number of people.

Beyond that, we have a moral responsibility to help others. Time is absolutely critical. If the government forces scientists to attempt to make adult stem cells, they like embryonic stem cells, they might waste five years or more and fail. In the meantime, hundreds of thousands will have died.

Why do we need therapeutic cloning? As a layman, several important reasons come to mind: one, implantation of human ES cells is not safe unless they contain the patient's own DNA; two, efforts to repair central nervous system disorders may need to recapitulate the process of fetal development and that can only be accomplished by human ES cells; three, therapeutic cloning is done without fertilizing an egg. It can be strictly regulated. If we also enforce an absolute ban on reproductive cloning, we will not slide down that dreaded slippery slope and do more unethical chaos.

Any new technology comes with the possibility for abuse, but when we decide that the benefit to society is worth the risk, we take every possible precaution and go forward.

REEVE: The unfertilized eggs that are going to be used for nuclear transplantation will never leave the laboratory, will never, ever be implanted in the womb. But if we don't make this research legal, if we don't use government funding and oversight, it will happen privately, dangerously unregulated, and uncontrolled, and our country is about to lose its preeminence in science and medicine.

We took a giant step backwards in the 1970s, when the NIH was not allowed to fund in vitro research and donor advisory commissions could be formed to consider the issue. In the meantime, there was rapid progress in England, and the first "test tube baby" was born in 1978. For purely political reasons, we didn't succeed here until 1981, and now IV clinics are commonplace, and so far 177,000 children have been conceived in 400 facilities around the country.

Today, human trials to defeat Parkinson's are underway in Sweden. In Israel macrophazias (ph), which are scavenger cells that eat debris in the body are being used to repair the damaged spinal cord within two weeks of injury. The first human subject was a 19-year-old girl from Colorado. Last week, the House of Lords in the U.K. passed legislation permitting research on cloned human embryos for the second time.

Those are not rogue nations behaving irresponsibly. They are no less moral than we are. If we act now, we still have a chance to catch up. I urge the Senate to defeat Senator Brownback's bill, H.S.1899, and pass your bill, H.S.1758. Thank you very much.

KENNEDY: Thank you very much.

Dr. Berg?

BERG: Mr. Chairman, members of the committee, I want to thank you for inviting me to testify for you on this very important issue. I have followed the stem cell debate and the cloning questions that we are going to address today, and I welcome the opportunity to weigh in with my own views on this matter, and it's also a very distinct privilege to join Mr. Reeve, who has been such an articulate spokesman for support of research that could contribute therapies and cures for debilitating diseases, spinal cord injury being his most personal issue.

The specter of cloning that's generated by films and novels has obscured the role and importance of the process in some of the most recent advances in biomedical research. Cloning is a scientific term to describe the preparation of a nearly infinite number of copies of, for example, a single molecule, a single cell, a virus or a bacterium.

For example, cloning DNA molecules was essential for solving the human genome sequence. Similarly, cloning DNA is critical to fight against bioterrorism, and has already been used in the determination of the entire genome sequences of several organisms identified as bio weapons. Furthermore, cloning is integral to modern, forensic procedures, medical diagnostics, vaccine development, and the discovery and production of many of the most promising drugs.

Cloning is also used to make genetically identical plants and livestock, enabling continued agricultural breakthroughs necessary to feed a rapidly growing and undernourished world population. I regret greatly that the frightening thoughts conjured up by the term alone have clouded the issues that confront us.

That said very few, if any, reputable biomedical scientists condone attempts to produce a cloned human being. In the words of the distinguished National Academy of Sciences panel that considered this issue: "It is dangerous and likely to fail."

In short, there are unacceptable risks to the mother and any fetus that would result from the procedure. Moreover, there is no compelling reason today or perhaps in the immediate future to attempt such a procedure. Therefore, I support the portion of Senator Brownback's bill that mandates a legally enforceable ban on reproductive cloning.

But Senator Brownback's proposed legislation goes far beyond a prohibition of reproductive cloning. His bill also includes two provisions that I believe deprive American patients access to potential therapies for some of the most debilitating diseases. The first of these would impose criminal penalties and heavy fines on scientists who attempt to transplant the nucleus from a normal body cell into a human egg cell whose own nucleus has been removed.

The power of this procedure is that such an asexually produced product can be nurtured to divide a sufficient number of times to produce a ball of cells within which embryonic stem cells reside. These stem cells can be propagated in Petri dishes virtually indefinitely, all the while retaining the capacity to be coaxed into forming any of the body's many cell types.

The particular value of nuclear transplantation technology is that the embryonic stem cells and the differentiated cells and tissues they yield have the same genetic makeup as the individuals that donated the nucleus. Consequently, they can be used to repair or replace damaged or diseased tissues, without invoking immune rejection that would occur with unmatched cells. In a sense, a person's own DNA is used to create compatible cells for the treatment of, for example, that individual's cancer, diabetes, spinal cord injury or Parkinson's Disease.

A particularly promising opportunity that is also foreclosed by the Brownback Bill is the preparation of stem cells, using body cell nuclei from individuals with inherited mutations, particularly ones that predispose such individuals to an increased probability for developing a variety of life-threatening and debilitating illnesses late in life. For example, breast cancer, colon cancer, prostate cancer, are all late onset diseases, which we have an opportunity to study the evolution of that process by using stem cells that are derived from individuals that carry such predisposing mutations.

Such currently unavailable stem cell lives could provide a new way to explore how these life threatening, late onset diseases develop, and possibly generate clues to their prevention or cure. Such studies might help illuminate the inner relations among inheritance, environment, and chance that govern so much of the balance between health and disease.

Now, Senator Brownback has been outspoken in his belief that experimentation with embryonic stem cells for therapeutic purposes is wholly unnecessary. He and others believe that we already have the means to meet that challenge by using what are called adult derived stem cells. These are specialized cells that already exist in many of our tissues, and are capable of repairing damage or diseased tissues.

Unfortunately, Senator Brownback has relied on claims that are largely anecdotal, most often un-replicated by others, and in some cases experiments that are demonstrably flawed. Today, there is not a well-documented instance where adult derived stem cells can differentiate to produce many different cell body types.

While some adult derived stem cells undoubtedly hold promise for certain therapies, for example bone marrow reconstitution, repair of damaged heart muscle, liver and neural tissues, their potential is limited by their rarity and the consequent difficulty of harvesting and propagating them in quantities that could ever be used for therapeutic purposes. Furthermore, their developmental potential is limited compared to the multi potentiality of embryonic stem cells.

Every scientific review of the therapeutic opportunities afforded by adult derived and embryonic stem cells has concluded that embryonic stem cells are far more versatile for medical therapies. Nevertheless, scientists working in these fields recommend strongly, as do I, that research should proceed vigorously with both adult and embryonic stem cells, so as not to delay or forego reaping their benefits for patients as soon as possible. It would be a big mistake to make a early bet on adult stem cells as providing the answers, only to find out five years later that we've made the wrong bet and have to go back and retrace years of research.

Now, one of the concerns that have been cited is justification for the criminalization of the nuclear transplantation procedure is to guard against rogue attempts to implant the product into a woman's uterus for the purpose of creating a cloned child. But surely, we have other means for preventing that very unlikely possibility.

You may recall, as you've already pointed out, Senator Kennedy, that 25 years ago in response to widespread concerns about the possible dangers of recombinant DNA research, the U.S. Senate came close to imposing severe criminal penalties on such research and development in this country. Had that occurred, it would have cost our nation its scientific eminence and the world's leading biotechnology industry.

Fortunately, another means was adopted to insure that the work could be done safety. That included regulation, which mandated oversight by an institutional review process and approval by the National Institutes of Health Recombinant DNA Advisory Committee before any of that type of research could be undertaken.

Once approved, the committee monitored the researcher's progress to insure compliance with governing regulations, a process resembling the one I just outlined, or one that's close to it, with institutes to oversee gene therapy experimentation. Gene therapy experimentation could be implemented to insure that nuclear transplantation technology is done to advance only medical knowledge and medical therapies, and not for procreation. Appropriate penalties could certainly be leveled on individuals or organizations for gross infractions, or deliberate violations of these prescribed procedures.

The third provision in the Brownback Bill, which has escaped close scrutiny and discussion in the public debate, is the one I find particularly onerous, and here I want to express my deep concern about the provisions of this third part of the Brownback Bill. The bill mandates the same severe criminal penalties on those who import into the United States materials or medical treatments that were developed using the nuclear transplantation technology wherever it has been done.

It seems unbelievable to me that the United States Senate would enact legislation that would deny physicians or their patients access to the most advanced therapies. If passed, millions of suffering Americans would be denied the hope of cures for their disabilities because certain members of our Congress have an aversion, admittedly deeply felt, to a procedure that was used in its development. Surely, we must concede that all of us have a responsibility to those suffering from life threatening diseases and severe handicaps, to explore every opportunity and every means to alleviate their suffering.

I want to conclude my commenting that we take considerable pride in being a pluralistic society, so there must be ample room for differences, concerning the moral and ethical interpretations of early and intermediate stages of human development, especially where acknowledging these ultimate and equally legitimate views can mean the difference between life and death for many of our citizens. Thank you very much.

KENNEDY: Thank you very much.

Dr. Murray?

MURRAY: Thank you, Senator. I want to thank the committee for the invitation to speak on the issues of human reproductive cloning and the use of nuclear transplantation and research with human stem cells. My name is Tom Murray. I'm president of a place called the Hastings Center, a resolutely non-partisan and fiercely non-profit research institute, devoted to ethical issues in health and medicine.

We're very successful in, I think, both of those, heath and medicine, the life sciences, and the environment. And until it was allowed to just disappear into the sunset in October of last year, I was a presidential appointee to the National Bioethics Advisory Commission. I should also note that I've spent most of my life thinking about the ethical issues involving parents and children. I'm the author of a book called "The Worth of the Child."

The National Bioethics Advisory Commission was charged with deliberating and offering advice on a range of issues in bioethics, including human reproductive cloning and research on human stem cells. I have the honor and the awesome responsibility of participating in those deliberations.

MURRAY: This body, and the House of Representatives, has the even more awesome responsibility of setting our nation's policy on these issues. I offer my remarks with gratitude and respect.

There are individuals who have proclaimed their intention to attempt to create a child through cloning. These proclamations show an appalling lack of understanding of the scientific difficulties involved, and the horrendous carnage left in the wake of efforts to clone other mammalian species, as well as the increasing evidence that even apparently healthy clone mammals are, in fact, far from normal.

More importantly, the entrepreneurs who want to rush into human reproductive cloning show a stunning indifference to the great ethical issues it raises. The commission concluded in its report on human cloning in June, 1997: "At this time, it is morally unacceptable for anyone in the public or private sector, whether in a research or clinical setting, to attempt to create a child using somatic cell nuclear transfer cloning. I think that conclusion is as valid today as it was nearly five years ago.

We relied on two lines of reasoning. First, given the risks and uncertainties, any effort to try to create a human child through cloning, would constitute morally abhorrent research on human subjects, both on any child so created, though unlikely, and on the woman who would have to bear that child. If anything, the accumulating scientific research since then has reinforced that argument. Reproductive cloning is a perilous and uncertain enterprise. Attempting it on humans would be grossly unethical, human experimentation.

Unfortunately, in the United States, not all-human experimentation is publicly accountable. Studies done with private funds may escape the procedures we have created to protect human subjects.

The second line of reasoning the commission employed was to call attention to ethical issues beyond the ethics of human subjects research. In the report, we referred to "many other serious ethical concerns that had been identified, which require much more widespread and careful public deliberation before this technology may be used," and I would add if it would ever be used to try and make a baby.

These concerns include a broad range of issues from the meaning and nature of parenthood to the limits and wisdom of attempting to control the traits of our children. I'm pleased to see that the new presidential bioethics body, the President's Council on Bioethics, is taking up the commission's recommendation to deliberate further on those issues.

Human cloning advocates have had a very difficult time coming up with a plausible scenario for when reproductive cloning would be good for any child so created or for its parents. The most sympathetic scenario, replacing a lost child, is also fraught with moral peril, as it creates impossible expectations for the child, and ultimately futile effort to fashion a technological escape from grief. Committee members who have seen my writing in the Washington Post will know that I speak from experience.

Nuclear transplantation in research with human stem cells is a different issue. Federal funding for research on human embryonic stem cells has been approved for certain cell lines, and in September, 1999 prior to that, the commission issued its report on stem cell research.

The report recommended federal funding for research on human embryonic stem cells, but only for embryos left over after in vitro fertilization and destined to be discarded. At that time, the commission also proposed very stringent safeguards to insure full and formed consent of the adult donating such embryos for research and to prohibit commerce in embryos.

It is important to note the commission consulted a broad variety of experts in theology, from at least four great religious traditions, Roman Catholicism, Protestantism, Judaism and Islam. We discovered a range of views on human embryonic stem cell research within, and not merely among those traditions, including among Catholic and Protestant theologians, some of whom opposed stem cell research, and some of whom argued that their tradition properly understood and permitted it.

In the 30 months since the report was issued, research on human stem cells has proceeded with great vigor. Scientists can not say with certainty which avenues of research from which sources will lead to important discoveries or new therapies, nor can they say with certainty whether research involving nuclear transplantation will contribute to breakthroughs. The path is rocky and uncertain however promising it may be.

What scientists can say is that to block off a particular path, indeed to make pursuing it a criminal offense, is an extraordinary, if not unprecedented barrier to research with unknown consequences for the development of possible new therapies. There are important positive steps we can take now to control destructive uses of the technology. We can insist that all such research, whether publicly or privately funded, must be conducted according to the most stringent ethical standards. This would require legislation, bringing such research under what's called the Common Rule of the standards the Federal Government has to protect human subjects and this is called for, as I understand it, under the Feinstein-Kennedy Bill.

We can also begin to enhance public accountability of the virtually unregulated infertility industry in the United States by establishing very stringent standards for procuring human eggs, now left to an essentially unregulated market. Thank you very much for this opportunity.

KENNEDY: Dr. Norsigian, we're glad to have you.

NORSIGIAN: Thank you, Senator Kennedy. I'm not a doctor. I think you know that.

KENNEDY: Oh, I see. Yes, I'm sorry.

NORSIGIAN: I especially want to appreciate your many years of wonderful advocacy on behalf of women's health. You are truly a dedicated public servant. I'm the Executive Director of the Boston Women's Health Book Collective, best known for "Our Bodies Ourselves" now in its seventh edition, "Our Bodies Ourselves for the New Century" and since 1970, over four and a half millions of this book have been distributed worldwide, probably a readership of over 30 million women and many men. There are 10 more editions on the way, and for over three decades, we have been very strong advocates for women's reproductive health and rights.

At the outset, let me make clear that my organization and many of our colleagues in the women's health and reproductive rights movement support embryonic stem cell research, but we also believe that a moratorium on all human embryo cloning is necessary at this point in time. It has been disheartening to see so little differentiation between embryonic stem cell research and embryo cloning in media reports, so much so that many people I need today tell me that they thought that the two were one and the same, even my colleagues, I might point out.

Those of us who are pro choice want to emphasize that our position is quite different from those who oppose all embryonic stem cell research. Many of us support, for example, obtaining stem cells from embryos in IBF clinics that would otherwise be destroyed.

In June 2001, our organization joined with other individuals and organizations to produce a widely circulated position statement on cloning. It called for a ban on human reproductive cloning and a moratorium on embryo cloning solely for the purpose of research. It is signed by over 100 groups and individuals with long and impressive track records, working in women's and children's health, and is added to my formal statement.

Many of our colleagues in other countries have signed on. Some translated it to present in Brazil at the World Social Forum, where a debate on this subject did ensue as well. We believe that cloning technology causes vastly greater risks than other currently available reproductive technologies. It is highly likely that experiments in human embryo cloning would inevitably lead to an acceptable germ line, human germ line genetic manipulation, and poses that to many basic human rights.

It will be extremely difficult to prevent research on human embryo cloning and related technologies from being used to produce so- called designer babies. Germ line genetic manipulations would affect future generations in unpredictable and possibly deleterious ways. If we allow research cloning to go forward, it is imperative that an adequate regulatory framework be established first. This is no simple take and it would undoubtedly require several years to address all the complexities involved.

Bills that now allow research cloning to go forward do not do this. Hence, a primary reason for the moratorium position. I also want to urge all of you to read Shannon Brownlee's excellent piece in the March issue of the "Washington Monthly." It's a superb bit of journalism.

Media coverage of human embryo cloning research has largely focused on its therapeutic potential, neglecting the technology's dependence on the thousands, if not millions of women who must undergo the substantial health risks associated with harvesting their eggs. Of particular concern to us is the lack of adequate long term safety data on the super ovulating drugs that women have to take in order to provide the eggs for embryo cloning.

I believe that adequate informed consent is not even possible at this time, so that following NIH research guidelines would not be enough, and I want to echo some of Senator Landrieu's comments earlier, and respect many of the points that she made.

In some recent testimony, one researcher stated that stem cells might be able to provide up to 1.7 million therapies per year. This would require a minimum of five to eight million human eggs per year, assuming a very optimistically high success rate of one stem cell culture out of three to five clonal embryos, that it is highly likely that many women will become repeat donors and that there would be massive expansion in the use of women as paid egg producers. We know nothing about the health risks of such repeat donations.

From our conversations with scientific experts in this field, we are convinced that there has been gross exaggeration regarding the current state of embryonic stem cell research. There is still much to be learned in this potentially promising field, and a moratorium on human embryo cloning would not halt progress in key areas.

Well before embryo cloning research proceeds, much additional work with human embryos is necessary to address problems related to the cancer causing tendencies of embryo stem cells and problems with controlling how these stem cells differentiate into the tissues needed for therapy. Knowledgeable scientists have affirmed that this work is more readily performed with standard embryo stem cells; thus, the moratorium that we propose will not cause significant delay in this line of research.

A moratorium would also allow for other important legal and ethical implications of embryo cloning to be addressed. As others have pointed out, an inadequately regulated industry in cloned human embryos will likely be to unacceptable co modification of life. The U.S. Patent and Trademark Office has already indicated that cloned human embryos would be patentable, and we have yet to prohibit the sale of embryos or human ovum necessary for this technology.

If Congress intends to create an effective ban on human reproductive cloning, a careful system of regulation and control over production of all clonal embryos is essential. As my written comments point out, this enforcement would be practically impossible so it's even more imperative that we really have proof of the concept here that embryo stem cell research goes much further in demonstrating its merit, before we allow the mass production of clonal embryos.

The public has only just begun to awaken to the possibly ramifications of the genetics revolution. We need to proceed thoughtfully and deliberately, put in place necessary regulations, and be wary of inflated claims made by those with vested interests. Questions surrounding such issues as patenting genetic discrimination, genetic privacy and human research subject protection should not be resolved by scientists and biotech corporations alone.

As a society, we may decide that some technologies promise unbalanced a minimal positive utility that is inextricable from the threat of unpredictable negative consequences. It will take time to involve the larger public in a meaningful debate, but doing so will well be worth it. Thank you very much.

KENNEDY: Thank you very much.

Dr. Newman?

NEWMAN: Thank you, Senator Kennedy and members of the committee for giving me the opportunity to speak on these important issues. My name is Stuart Newman. I'm a professor of cell biology and anatomy at New York Medical College, where I teach medical and graduate students and direct a laboratory in developmental biology. This is a scientific field that studies embryo development, cloning, regeneration, and stem cells. My work has been supported over the past 25 years by grants from the National Science Foundation and the National Institutes of Health.

I have long believed that scientists who are beneficiaries of public resources have a deep responsibility to anticipate what lies down the road in their own field and to serve as a resource for the public on the complex issues around applications of scientific research. In the late 1970s, I helped found the Council for Responsible Genetics, now the nation's oldest public interest organization dealing with biotechnology.

I will state from the outset that I, and the Council for Responsible Genetics, as an organization, unequivocally support a woman's right to make her own reproductive decisions. Therefore, what I am here to tell you today calls into question technologies that manipulate, clone, genetically alter, human embryos. These views do not derive from any notion of the sanctity of the embryo, nor from attributing to it the status of a human being. Rather, our concerns derive from two distinct sources.

One, the irresponsible promotion of another scientifically questionable technology and conformity with, what is now a recurrent pattern of playing to investors' hopes and patients' desperation. And two, the destructive social consequences of moving down the technological path that begins with embryo cloning.

Specifically, cloning embryos for producing embryo stem cells will, by failing to deliver on its promises, inevitably lead to calls to extend the life span of clonal embryos so as to permit harvesting developmentally more advanced cells and tissue for research and potential therapies. The same well-intentioned imperatives that make some of you unwilling to deny patients who hope for relief by means of embryo stem cells, will make you or your successors susceptible to demands for increased access to improved products of this work, up to and including full-term clones from which to harvest organs.

I will try to lay out how this will happen. Embryo stem cells are derived from embryos that are less than two weeks old, the now proverbial clump of cells in the bottom of a Petri dish. If derived from a corner embryo, resulting from transfer into an egg of a patient's somatic cell nucleus, the stem cells will be a genetic match for the nuclear donor. Transplants derived from such stem cells will be compatible with the immune system of these patients.

NEWMAN: Please note, however, that this will be of little advantage to patients with Type I Diabetes whose condition causes them to immunologically reject their own insulin producing cells. While such genetically matched cells may be tolerated by patients with other conditions, there are still likely problems. Two decades of research on embryo stem cells on genetically compatible mice, has yielded a handful of studies with modest therapeutic results, in all cases less than what has been achieved with graphs of non-embryonic cells.

Despite great efforts, embryo stem cells never become just one cell type or coherent tissue, but differentiate into disorganized mixtures of cell types. More importantly, they are genetically unstable. If placed in adult mice, they cause tumors. There is every reason to believe that embryo stem cells, including those from cloned embryos, would cause cancer in human patients. To overcome this, if it is indeed possible, will take years of research. Some way it's worth a try and scientists and companies with patents on this technology are willing to make the attempt.

However, science and medicine always gravitate toward better technologies. In fact, there is a different kind of human stem cell. These are derived from eight to nine week human embryos, and like embryo stem cells, these so-called embryo germ cells can differentiate into all cell types. Most importantly, when transplanted into experimental animals, they do not cause cancer. On purely scientific grounds, embryo germ cells show even greater promise than embryo stem cells.

Now if they were derived from clonal embryos, they would be nearly perfect, again in a purely scientific sense. But interesting, none of the advocates of permitting embryo cloning has raised the specter of growing clonal embryos for eight to nine weeks so that genetically matched embryo germ cells could be harvested. These embryos would, of course, no longer be clumps of cells in a Petri dish, and some supporters of embryo cloning here might object.

Right now, it would be a hot potato, but once we have clonal embryos for a while and have gotten used to the idea, who would turn a deaf ear to calls by patients and their loved ones for these superior therapeutics?

And once stem cell harvesting from two-month clonal embryos is in place, who could resist the pleas to extend the time frame so that live and bone marrow could be obtained from six-month clonal fetuses to clear sufferers of life-threatening blood disorders, such as Beta Thalassemia, or so that green lining cells could be harvested from near term fetuses to treat Parkinson's sufferers?

I emphasize that all of this makes perfectly good scientific and medical sense. The only thing that stands in the way is the sense of propriety concerning the uses to which developing human embryos and fetuses may be put. Some of you may draw the line at the tiny clump of cells, others at the two-month embryo, still others somewhat shorter full term. Wherever each of you decides to leave this particular train, there will be others who will insert their right to take it to the next station.

Few in this room would go along with the more extreme possibilities, but what about future generations growing up in a world in which producing clonal embryos for spare parts is medicine as usual? Not only this, but the scientific publications that will ensue, if embryo cloning proceeds, will enable those reckless individuals who have announced their intention to make full-term clones and then genetically improve clones to do so. Those who think that handling clonal embryos as controlled substances in regulated laboratories or stop the transfer of the technology do not understand how science works.

This is my prediction. If embryo cloning is permitted, within a few years, frustration over lack of progress in producing safe and effective therapeutics from embryo stem cells will lead to calls to permit harvesting of embryo germ cells from two to three month clonal embryos, and when they all find themselves here again, the rest will be just a matter of time.

But there are other possibilities. Stem cells derive from adult tissues and umbilical cord blood, have already proved to be effective therapeutics in animal models and clinical trials. There is less commercial interest around them since it is difficult to obtain patents on a patient's own cells.

Correspondingly, however, these cells are immunologically compatible with the patient from whom they are derived. It will take much additional work to make this technology practical, but scientifically and societally, I am convinced that this is the way to go.

KENNEDY: Thank you very much, Doctor Newman, and I'll ask the staff. We'll try five-minute rounds so everyone has a chance to question and I know there will be many.

Doctor Berg, I think for the people that are hearing this presentation, and also that are watching on television, would like to know, you as a Nobel laureate, in lay person's language, why is it that this type of research offers really such greater opportunity for breakthroughs on the kinds of illnesses and diseases that most families are facing, rather than other types of research that are taking place in research labs all over this country? What is it that's so particular? What is it so special? What is it that's so unique about this? If you could do this as quickly as you can because I got some other things.

BERG: I usually do this is an hour lecture.

KENNEDY: OK.

BERG: Embryonic stem cells have the unique property of being able to be propagated almost indefinitely and retain the capacity to differentiate into all of the body cell types. We have been studying this process in mice for nearly 25 years. It has produced enormous discoveries, all of which have only raised the enthusiasm for being able to explore the same kind of properties in human embryonic stem cells.

For the nuclear transplant, when the President approved the use of the so-called 65 stem cell lines, these are ones that have been produced by random populations. They were taken from IVF Clinic freezers and stem cells were harvested. There's no information about the genetic background of these individuals.

We know, for example, that many of the late onset diseases that I talked about arise because of inherited predispositions. You inherit a gene, which predisposes you to develop colon cancer or breast cancer. There's a number of events that must occur before a full- blown cancer develops. We have no way of really studying that process with any success.

It is possible now to be able to go to an individual who has such an inherited predisposing mutation, produce a stem cell line, and be able to examine and study the process by which the disease develops.

KENNEDY: That is true like in cancer. It's true in Parkinson's Disease, diabetics?

BERG: Exactly. Many of our diseases that we're plagued with are, in fact, late onset. They appear later in life, and if these diseases, which we only know retrospectively were, in fact, caused by an inherited mutation that was inherited from one's parents, so if we can make stem cell lines that start at ground zero, starting point, have a mutation. Now we can begin to examine, as development occurs, the succeeding mutations that will ultimately lead to this pathogenic state.

KENNEDY: And that's really unique in terms of life.

BERG: It is unique, and we have no other way of exploring that in my view, and this is one potential. Now many people say, "well, that's research. What is that doing for patients?" Well, we need better and more information about how cancer develops. Ultimately, as we learn more about this process, we're apt to be able to come up with procedures and therapeutics that can interrupt that process, if we can identify successive stages.

So, that is one area, but I think in the area of therapy, if I may just take another moment. The whole idea is that lines that the President approved can not be transplanted into anybody safely. Today, they can not be used for that purpose. They can be used for research and studying some of the processes of how we induce these cells to differentiate, but they won't be usable for therapeutic purposes.

For therapeutic purposes, we're going to need something that is genetically matched to the individual who will receive the transplant, and for that purpose, that's what the therapeutic, or so-called therapeutic nuclear transfer technology can achieve.

KENNEDY: That's why the President's numbers have really failed to meet the opportunities that are there in terms of research, is that right?

BERG: Not only have they failed that purpose, but in fact -

KENNEDY: My time is running out here. Is that right?

BERG: Yes.

KENNEDY: Let me just, we're going to have six-minute rounds. Mr. Reeve, I'll just ask you, we have heard a good deal about the slippery slope. If we have research in this area, the next thing we're going to have is human cloning. We are all opposed to human cloning.

REEVE: Right.

KENNEDY: This is raised in many instances as a red herring on this issue. We're opposed to it, Senator Feinstein. I don't know a member of the United States Senate. That isn't what this debate is about. It's about what has been described earlier by this panel and by which you have spoken so eloquently about. Tell me from your own experience of working in this area, do you have concerns that if we see this kind of research go ahead, this will lead us on a slippery slidy slope.

REEVE: No.

KENNEDY: We'd just end into going into human cloning and all of the legitimate horrific kinds of circumstances will take place?

REEVE: If you believe in the slippery slope here, it means that our entire society is perched on the slippery slope, because it means that regulation has no value whatsoever, and that's not true. Now there always are consequences. We allow 16-year-old people to get driver's licenses. A lot of them have accidents, but do we rescind the permission to drive a car at 16? No.

I mean look at nuclear energy right now. We're very concerned that rogue nations are going to get a hold of nuclear technology and come back to haunt us, but we're not stopping our own nuclear capability. In fact, the administration is trying to enhance it.

And also, just on a daily basis, the government is saying to people, "yes there's a threat of terror, but fly and go to the theater and live your life and take that risk" you know, because every day you hear about our headquarters having to take some airplane back to the airport because there was the threat of a bomb. People are getting aboard airplanes, passing security checkpoints, and found to be carrying dangerous material, but still we go on.

So yes, you take a risk that somebody, somewhere should get involved in creating a human out of reproductive cloning, but it is not at all likely, and to be afraid of pursuing DNA - of therapeutic cloning is really going to be reprehensible, because you can't use embryonic stem cells for a therapy without being able to use therapy in cloning. It won't work.

KENNEDY: Thank you very much. Senator Frist.

FRIST: Thank you, Mr. Chairman, and I appreciate the testimony of everybody today. It's helpful, although I'm glad we're having the chance to talk further, because I don't think we've addressed what fundamentally is most important, if we're going to legislate in this area at all, which I think we are because everybody has said we ought to ban reproductive cloning. So we're going to be there.

And to my satisfaction, none of you, Doctor Berg or Mr. Reeve, Doctor Newman have really clearly outlined the differences, the distinctions between stem cell research and cloning. It is so basic, and we've got to do it. It's horrid, because as soon as you talk about cloning, very quickly Mr. Reeve you do and Doctor Berg, you immediately go to stem cells and embryonic stem cells and the promise and the hope, which is there, and I agree.

But some way we need to separate the two and say, what do we lose if we have a ban on research cloning therapeutic cloning, regenerative cloning in humans at this stage, recognizing that we haven't fully explored animal models completely at this juncture. What do we lose? Do we really pull back the promise of stem cell research, embryonic stem cell research, fetal stem cell research, adult stem cell research, by having a ban on cloning?

And again, I want to come back to that shortly in probably a second round, as we come through, because I don't think we fully addressed it, and the temptation is to go back to embryonic stem cell, which does have great promise and I'm a big advocate for that as we go forward.

Senator Landrieu mentioned the technologies that are still allowed. It's very important for my colleagues and for the American people to know that a ban on research human cloning, the cloning of human organisms. I mean the definition that is used is human organism, asexual reproduction and there are some other qualifications there for a human organism, that that's what we're talking about. It doesn't in any way inhibit other types of research.

It's important for all of us to understand, for example, things that can still continue and still should continue in humans or not humans. I'll go through the list. Cloning to produce any animal. Again, animal models for cloning would continue and hopefully be supported federally and otherwise, cloning, nuclear transplantation, nuclear transfer to produce any animal, any species, other than a human being. Cloning of any cell other than a human embryo would still continue. Cloning of DNA would continue or RNA continue, protein or any other molecule would continue, parthenogenesis.

This goes into too much detail, but again, one of the arguments for cloning is that it increases the supply of embryos that we can set on this track of embryonic stem cell research. You increase the supply right now, but supply is the 73 stem cell lines that the president has made available.

FRIST: Some people for using leftover embryos that are going to be thrown away anyway, why not use those for research? And another would be the cloning, as an input there. And parthenogenesis, we won't talk about it today, but will still be allowed. That's inducing an egg to keep all of its chromosomes.

Androgenesis, where you put two sperms in a nucleated egg would continue. Embryo splitting, what's called the Induced 20, we talked about it in some hearings about a year ago, would continue. Blastemy or separation of an embryo to produce multiple embryos would continue. Pre-implantation genetic diagnosis would continue. Human embryonic stem cell research on all existing cell lines would continue. And, Doctor Berg, I mention that because you said there's a lot to learn there in those 72 lines.

BERG: If you can have access to them.

FRIST: If you can have access to them?

BERG: Yes.

FRIST: And as you well know, there are nine applications right now. That's all that have been received to date, and so there's a great surge out there, but nine are being considered right now. So people do have access to those lines in the approval process. Derivation of new human embryonic stem cell lines from fertilization embryos will continue. Creation of human embryos by fertilization for reproduction will continue. Any embryonic stem cell research, adult stem cell research would continue. Placental stem cell research continue. Fetal tissue research continues. In vitro fertilization continues.

I go through that list, not to drive the point home too much, but it's important to know there is a lot down this sort of basic research that is important as we enter these uncharted territories. It does lock down an area for the reasons that go back to this sort of moral, ethical arena, and it really comes down, and again I'm going to run out of time here.

But it comes down to the creation, and this is what bothers so many, that one of the major ethical objections to human cloning research cloning, is the purposeful creation of cloned human embryos, which must then be destroyed in the experiment. These are all experiments. The investigations are research, but they're experiments. But you have to destroy the group of cells, the embryo there.

In the experiment, you create what many people, including myself, regard as life and you then must destroy that as a necessary part of the experiment today, maybe not in the future, but today, and I think that's what bothers so many people. There's something intrinsically, morally wrong, offensive, choose the word, about creating and destroying human living material for an experiment, especially before the basic investigations have been carried out in animals and animal models. I'm running out of time, but I'm going to come back in the second round to give people an opportunity to respond.

KENNEDY: Senator Dodd. It's a long list you had there of items.

DODD: Yes.

KENNEDY: You left out umbilical cord. It's in there.

FRIST: Yes, I said placenta.

KENNEDY: Placental, OK. I have it in there. That's what my wife and I use and I was waiting to hear some good news about that.

DODD: This has been very compelling testimony. I'm tempted to want to ask, rather than us asking questions. I can think of several, but I'd almost like to give you a chance to talk to each other a little bit here, and I wonder if you might comment on, ask Doctor Berg to comment on some of the statements made by Ms. Norsigian, and Doctor Newman.

They raise for use the issue, while possibly the umbilical cord, blood, stem cells, stem cell research, adult stem cells are not, animal work is not yet to the point where it can produce the results that therapeutic cloning could. Obviously, I think, most accept the notion that the science of that, and I'll ask you to comment on this as well, it's clearly more advanced than harvesting adult stem cells for instance.

But yet, what promise does this particular technology offer in the near term, so as to avoid the very issue that brings us to this debate. And I wonder if you might engage each other a little bit in this discussion.

BERG: Could you - may I ask you to clarify the point. Are you asking whether the adult stem cell research is sufficient to take us some direction at some point?

DODD: We inquired, for instance, with a newborn about the wisdom of taking umbilical cord blood.

BERG: Yes.

DODD: Interestingly, I got a lot of different responses and can only find one or two places that would even keep it without, a couple of private places, but one children's hospital out in Berkeley, I think in fact is one able to store it. And I was fascinated - first of all, we don't encourage more of this. I can tell you that the obstetrician wasn't overly delighted about having to take the umbilical cord at the time of birth. It was confusing and took time and so forth to do it.

I've since discovered that my daughter is going to have a wonderful opportunity, at least in terms of blood, she directly will be the beneficiary. It's not impossible her mother may also be the beneficiary. It also may be possible I may be a beneficiary at some point. I'm reading about now where there are children who have no relationship whatsoever to the suppliers of umbilical cord blood that also might benefit as a result of Sickle Cell Anemia and the like. How far away are we from this? Is this distant research that may one day do this, or is it available in the relative near term possibly?

BERG: There are actually clinical trials using hematopoetic, that means bone marrow stem cells, and these have been isolated and can be shown to reconstitute the entire bone marrow population and all of the blood cells. But that it's also been shown to have very limited potential to being able to populate any other organ. So there's now clear data. It has very limited potentialities for those purposes. For where it is useful, extraordinarily useful and, in fact, there are large banks being developed to store umbilical cord samples, because if you have a large enough bank, you might be able to actually be able to find batches.

Remember, when you do transplantations, you have to have a perfect tissue match, or else these individuals will have to be immunosuppressed for the rest of their lives. So your daughter's umbilical cord blood may work with either you or your wife, but they're not likely to work for many other.

DODD: Unless you can find a match?

BERG: Unless they're a perfect match, OK.

DODD: That there have been cases of.

BERG: Yes, there have been though.

DODD: But you have to collect very large samples.

BERG: Actually, interestingly enough, this business of immunorejection would be solved if you could make a million different stem cell lines. The President said only 64 over that time. You could make a million or an unlimited quantity. You could, in fact, ultimately develop stem cell lines that would match most people's immunological barrier.

DODD: Let me jump if I can to Ms. Norsigian to respond to the question. I'd like to get you to engage each other a little bit here.

NORSIGIAN: I'd like to agree with and extend something that Professor Berg said. It turns out that adult stem cells from bone marrow have wider potential than was thought even a year or two ago. Muscle cells can arise from bone marrow stem cells. Nerve cells can arise from bone marrow stem cells. Then there are stem cells that are harvested from the lining of the brains of cadavers, of donated bodies, and those not only turn into nervous tissue, but can turn into bone marrow cells, and can turn into muscle cells as well.

So, it turns out that taken as a collective, the population of adult stem cells has as wide a potential as embryo stem cells. Now each individual population of adult stem cells may not exhibit the full potential, but taken as a collective, from the different parts of the body, even fat, stem cells that have been harvested from fat, it can turn into muscle cells, can turn into blood cells. I'd just like to say a little bit about -

BERG: I'd like to contest that because I think that's incorrect.

NORSIGIAN: Oh, OK.

BERG: The point I tried to make earlier, that is the work with adult stem cells have shown very limited multi-potentiality.

NORSIGIAN: Right.

BERG: Very limited, and there are experiments now which show that bone marrow stem cells, which can regenerate complete bone marrow and repopulate the entire blood cell population do not lead to repopulation of any other organ. So those experiments early on are incorrect and are now known to be faulty, for a very good reason.

NORSIGIAN: I mean I'm referring to articles that were published in the proceedings of the National Academy of Sciences in the last two years and "Science Magazine." I think it's debatable. In any case, there are problems with embryo stems or there were problems with adult stem cells in that they're difficult somewhat to harvest and to concentrate and their ability to reproduce and proliferate is not as great as embryo stem cells, but embryo stem cells have their own problems. They cause tumors and their very versatility is a liability.

We're have now 20 years of experience with embryo stem cells in mice and there's less than a half a dozen papers that show any therapeutic efficacy in animal models of human disease, and even though there are problems with tumors, there was a paper just published in (inaudible), tumors were caused even with very small numbers of these embryo stem cells.

So in a sense, to use embryo stem cells would take probably heroic genetic engineering of the cells to get the, first of all the potential of the cells to be more restricted, rather than more versatile. That's a problem, and then also to reduce or eliminate their ability to cause tumors, and this may be insurmountable.

With the adult stem cells, you have the problem of not reproducing enough, but we know how to immortalize cells by genetic engineering. So by fiddling with adult stem cells, we could probably surmount the problems with adult stem cells. So I would say that the way it looks to me now, and one other point, very important, sometimes it's portrayed that adult stem cells are old hat. We've known about them for a long time, but embryo stem cells are brand new and they show all this promise.

We've known about embryo stem cells for at least 20 years in mice, and adult stem cells have been very controversial until recently. People were not willing to accept that they even existed until about two or three years ago. So the actual cutting edge new science is in adult stem cells, not in embryo stem cells. We've tried them in mice and they haven't proved very effective.

DODD: Ms. Norsigian, I can see Doctor Berg is anxious to rebut some of this.

NORSIGIAN: Can I just say one thing? It's not directly about this, but it's that this debate and this discussion did happen in Canada, and I think it would be instructive to look to the North, where they just announced federal guidelines for federally funded research and did not allow embryo cloning to go forward, and just to date was part of their discussion there. So I just want to urge you all to look carefully at what happened there.

DODD: Doctor Berg, do you want to quickly follow.

BERG: There's a - Ms. Norsigian, you got that partly correct. Canada chose not to fund federally embryo - nuclear transfer, but they did not prohibit the research.

NORSIGIAN: That's what I said.

BERG: Well, I got a different sense of what was said. They clearly, they also did not criminalize the research.

REEVE: May I make a comment, please?

DODD: Of course, you can. He's my old neighbor from Connecticut, here.

REEVE: Thank you, Senator Dodd. In response to something that Doctor Frist said, I need to object to and that is that, Senator, you insist on separating therapeutic cloning and embryonic stem cells. However, in my own case, I require (inaudible) of nerves. That means replacing the conductive code of fat, myelin, that allows electricity to come down currents from the brain to the central nervous system for function.

At the moment, only embryotic stem cells have the potential to do that, and experiments are being done now in larger animals demonstrating that. And, I would say that if you don't back up the scientists at Washington University, Dr. John McDonald, who I've been working with, there is not way he would inject stem cells without being able to use my own DNA for safety reasons.

So without the ability to use my own DNA, without that somatic cell transfer, I'm out of luck. And the other thing is, to please remember that therapeutic cloning, nuclear transplantation, is done with unfertilized eggs and you keep referring to destroying an embryo. I think destroying an embryo is what happens when the leftovers from fertility clinics are thrown out.

We can agree they go to the garbage routinely, but to say that an unfertilized embryo, an unfertilized egg has the same status, I believe is incorrect, and I think that (inaudible) the line of research that holds so much promise and also can get us around the ethical quandary that we keep putting ourselves in. We're talking about an unfertilized egg that will never leave the lab, that will never be implanted in a womb, and that can be regulated. Thank you.

DODD: Thank you all very much. Thank you, Mr. Chairman.

KENNEDY: Senator DeWine?

DEWINE: Thank you, Mr. Chairman. You know, I think one of the things that we try to do in hearings like this is to educate ourselves, and we also try to educate the American people and try to maybe clarify some of the issues.

DEWINE: Doctor Newman, I found your - I found all of the testimony intriguing. I found yours intriguing; your use of the term, the over-hyping of another scientifically questionable biotechnology, and then you went on to explain in your written testimony what you were talking about.

I think when many people look at this issue, at least for the first time; their expectation is a lot more than maybe what the reality is. For example, I think some people believe that this research is going to leave to the creation of organs for transplant. For example, in a January, 2002 Washington Post article, they did a story on advanced cell technology in Massachusetts, and how they were able to grow "kidney-like organs with cows."

It's not readily apparent, and I think what your testimony really did clarify is that these cells don't really come from clumps of cells in a Petri disk. They come from developing embryos, and your testimony referenced that when you were talking about the embryo germ cells. The example you gave, I believe, you said the stem cells would come from what, eight to nine-week-old Embryos.

I think to most Americans that isn't acceptable, and I think it isn't acceptable because I think most Americans are opposed to creating human life just to destroy it for the purpose of research. I think most Americans would be opposed to a researcher being the one who chooses whether or not the embryos would be allow to fully develop, or whether they would be just allowed to develop long enough until their development could be used and exploited.

Doctor Newman, you say that in your testimony and I quote: "Short of saying no to embryo cloning, any line drawn will be a moving boundary." I think you're right. I think that is the essence of the problem and the challenge that we are facing. You know, people are already arguing that so long as it's not implanted, it's OK to create and destroy a five to seven-day-old embryo for research.

Where do you draw the line? What is to stop people? And I understand your position, that you are pro choice. I am not, but you are, and I think you've made that very clear. But I think your point about where you draw the line is very, very, to me very telling, and so I appreciate your comment very much. I don't have anything further, Mr. Chairman.

REEVE: May I ask a question please?

KENNEDY: Sure. Let me interrupt just a bit. Mr. Reeve has to leave for a plane in a few minutes, and I'd like to ask him if he has any comments that he would like to make just to the testimony thus far, and as you a question. I certainly commend you for your work, but personally on behalf of the tens of thousands of people who will someday benefit from these research endeavors, in your statement you rightfully characterize this as more than an abstract debate, that every moment we delay could mean a life or death sentence. Without this research, what alternatives would the disability fall back upon that you're aware of, and are there any?

REEVE: Well, I would start with ALS, and I think you could bring in any responsible scientist from any respectable institution to say that there is no hope at the present or projected for people with ALS, other than human embryonic stem cells.

I would also say that never in the history of science have we been given such a gift of being able to use cells that can become any tissue or cell type in the body for the purposes of healing. And I think if you don't have the combination of therapeutic cloning and embryonic stem cells, you're going to be condemning a lot of people to unnecessary suffering, and to death.

If I look around at what else is going on, I mean for years just in the spinal cord community, there has been research on growth factors and (inaudible) cells, and there's been efforts to stop protein inhibitor, but they have not yet shown the same promise that the embryonic stem cells do, and at the moment in two places, Washington University, and St. Louis, and the University of California at Irvine, researchers there have been conducting very successful experiments using human embryonic stem cells in animal models in both the acute and chronic phases and getting recovery.

Of course, they're going to have to move to the higher animal forms before humans, but the promise is absolutely extraordinary, and I can not think of any other kind of therapy that would be as effective and as promising as this is, and when I read articles or hear people say that the promise of stem cell, even embryonic stem cells, is (inaudible).

I am very disturbed because the only reason they get to say that is because the NIH has not been allowed to spend a single dollar on embryonic stem cell research. They have a budget now of $25 billion, and yet because of the lack of guidelines and because of restrictions that have been imposed on NIH so far. Not one human embryonic stem cell project has been federally funded. That's why you're seeing such slow progress, and if we continue that way, I'm going to be in this wheelchair for a long time, and I don't think I need to be, and others like me.

KENNEDY: Thank you so much, and thank you and your foundation for what you have done. I consider you a good friend and it's a pleasure to see you here again today.

REEVE: Thank you, Senator. I apologize having to leave. Thank you.

UNIDENTIFIED MALE: Thank you for being here. You have a voice and experience that other people don't have and we appreciate you making it.

KENNEDY: Doctor Berg, you've been itching to make a statement.

BERG: Not a statement. I want to raise an issue, which I alluded to as not having been discussed widely enough, and that is this importation ban. And, what I have been unable to fathom is why these bills, the Weldon Bill and the Brownback Bill, both prohibit therapies being applied in this country, if the technology has been developed elsewhere.

So, for example, you as a physician, Doctor Frist, if I were a physician and I had to confront a patient who said: "In England, where nuclear transfer technology has been pursued, has led to the development of the cure for my disease, I would like to avail myself of that opportunity." You as the physician would be required to say, "I'm sorry, but we can not provide you with that therapy because there is a law prohibiting its use."

Even if I went abroad and had the therapy carried out in England, to use that example, it's not at all clear that I would not be arrested or fined for bringing into the country things that have been derived from cells produced by nuclear transfer. So, I find that almost the most onerous part of this effort. It is, once established somewhere, and as Mr. Reeve said, they're not rogue countries, they're moral, and they will proceed in this direction, and if they produce a therapy, 280 million Americans are not going to be able to avail themselves of that therapy. I find that amazing, and so I want to know why that's part of the bill.

FRIST: I'll be happy to comment. I know we need to get around real quickly, and you and I have had this conversation. This is one of the points that people don't bring up very much, that I think does need to be addressed. As a physician who's committed to an individual patient, say Mr. Reeve, knowing that there's a therapy that I can reverse, or whether it's diabetes or Alzheimer's or Parkinson's, all the diseases that are out there, from an ethical standpoint as a physician, I'm going to find it and I'm going to do the best to that patient as possible.

What this provision is, is sort of the third part of this bill, which basically says, "I don't know how far you can go, but you can draw up this picture of saying there's a lifesaving therapy elsewhere and we're going to deny it to the American people." I think it needs to be worked on.

I think what is important though is that we don't put into a bill today that encourages saying, "no, we're too good. We have moral ethics in the United States of America, and we're going to go to the six-month fetus" and from countries where - or the six-month stage, not the embryo stage but before birth, that we're going to in some way make commodities out of infants in other countries, taking stem cells, embryonic stem cells, which offer the promise of cure.

And because morally and ethically we've decided to say, "no we're not going to do it. Other people can do it." It's going to be OK for us to bring that back in and import it, and I think that's what I assume the intent is today. I think we have to be very careful for the reasons that I said, as a physician, doing what's best for that individual patient, and I think that does need to be addressed.

KENNEDY: Senator Reed.

REED: Thank you, Mr. Chairman. Thank you all for your testimony. This is a very difficult issue, stating the obvious, a combination perhaps even a collision between ethics and medicine, economics and culture. I'm wondering, and Doctor Murray you might be able to help me, is this a unique sort of issue we're confronting, or have there been in the past issues something like this that might give us some insight about how to proceed? And I'm not an expert, but I would suspect that on that front, there were questions about transplanting organs into people and questions about use of blood, and similar objections might have been raised.

MURRAY: Well thank you, Senator. That's a wonderful question, by which I mean I haven't prepared to answer it in advance.

REED: Well, let me put it, after listening to this discussion, if this was an elected course, I wouldn't take it.

MURRAY: I would teach it only with great reluctance.

REED: I'm returning the favor, I guess.

MURRAY: Fair enough. In fact, there are people in this country, since you bring up the example of blood transfusions who have profound religious objections to blood transfusions. I mean it's not, this is not the first case in which we have people with deep, sincere, faith based objections to something that other Americans, large numbers of other Americans embrace as potential or actual therapy.

So I think there are precedents, and similarly the organ transplantation was greeted with some fear and trepidation, and not without reason, but we went ahead with it. It works. It is not perfect. People can tell you that to receive an organ transplant is to trade a fatal disease for another very bad disease, that is chronic rejection, unless you can get something akin to the perfect match that Doctor Berg was alluding to.

One observation I would like to make is that, it's very difficult to predict the course of the science. It's impossible to predict with any confidence, exactly where the science will go, even if it ever will lead to useful therapies. But, of course, we'll never know unless we try.

I actually have more confidence in predicting some of the ethics, at least over the next five to 10 years, and I don't think the scenario that Doctor Newman, who I regard as a friend and esteemed colleague, I don't think the scenario Doctor Newman painted is remotely realistic, and I'll give you at least two reasons.

Number one, we already had the issue in the United States about fetal tissue transplantation. We permit funding for fetal tissue transplantation research we have in this country, and we have very strict standards, and one of them is, no directed donation. If I choose to donate fetal tissue for the purpose of research, I may not say it goes to my son, brother, aunt, grandparent. I can't do that. We recognize this as a potentially perilous situation. It could put women in circumstances where they would be pressured to have, get pregnant even, or to have abortions. We wanted to avoid that, and I think if we stick to that standard, that gives us a moral purchase.

The second is if there's anything close to an international standard about research on embryos of any kind, and I think it's an open question how to think about entities created by nuclear transplantation, which are almost certainly not viable, given what we see with animal cloning, is that no research should be permitted on these - on human embryos after 14 days gestational age, after the appearance of the (inaudible) begins, and we're talking about less than half of that gestational interval.

MURRAY: So at least there are two more rules I I can pick out without preparation that are relevant. We could find more. Thank you.

KENNEDY: Yes, Doctor Norsigian.

NORSIGIAN: I'm not a doctor. I was just thinking about the many examples we have where there were important scientific developments with limited and appropriate applications, and we were told they wouldn't go beyond that, and we've seen many examples where they have. And I'm thinking of one case in point, because we nearly saw, I think, a very negative step taken, and that has to do with pre-implantation genetic diagnosis.

When it was first being developed, I was at a meeting where several researchers and scientists and physicians said, "we would never use this technology for sex selection alone, except maybe if you're trying to deal with a (inaudible) disease. You know, we want to use it for medical applications." Now many of you probably know, there was this controversial proposal that basically clinics be allowed to use pre-implantation genetic diagnosis, to have something called gender diversity. If you've got all girls, you want a boy or vice versa.

And there was a clinician in Chicago about to offer this, and this is something that I think is, maybe four or five years ago. I was assured, just as Doctor Murray, just assured you would never be the case, and then there were responsible clinicians saying this ought to be allowed. It's an example of how the envelope can get pushed, even when now we don't think it might be.

And, I can think of other examples as well, but that's just one that comes to mind and I think, fortunately, the American Society for Reproductive Medicine did issue a letter and suggested we should pull the reins in, but not until about 10 consumer organizations put out a press release, knocked on the door, and said "you got to do something." Now, that didn't get much attention. I'm not so sure they would have done it without the watchdogging of the consumer groups. This is where my trust is limited right now.

KENNEDY: Thank you. Doctor Berg, Senator Frist has a long, long list of procedures that would be presumptively allowable, and there's no one on this panel that knows more about the science of these issues. I'm just wondering if, in your view, are there other procedures that would not be permissible under this. Presently, that's what we're arguing about.

FRIST: I mean would this bill prohibit -

BERG: Yes.

FRIST: Well, it's very clear what it prohibits. It prohibits any attempt to clone a human being. No contest on that. The second one is it prohibits the nuclear transfer technology to create and embryo to produce embryonic stem cells. That's clearly prohibited by this bill. And the third one is the importation of any therapies that are produced using that technology, wherever it occurs in the world.

BERG: The focal point of the beta, is really those last two issues, since the first one I think I have a contention. I don't think there's any debate amongst the scientific community about prohibiting attempts to clone a human being. A huge controversy stems around the creation of stem cell lines, and for the express purpose of both therapeutic purposes, which we heard, because they're not likely to be rejected, and the other is the opening of new ways to attack serious problems of health at the basic research level. That's what I think would be foreclosed.

FRIST: Thank you. Thank you very much.

UNIDENTIFIED MALE: Doctor Murray, just to follow up on, I'm not sure whether to say Ms. or Doctor Norsigian. You've just been granted an honorary degree by this panel and I think you should take it. But I take her point to be an important one and to underline something that I said in my testimony and something that was actually included in the Feinstein-Kennedy legislation, namely that we should take, we should increase the scope of the coverage of human experimentation.

Right now, if you are simply privately funded, you do not have to get, you do not have to fall under the regular rules that govern human experimentation. We should bring all subjects of human experimentation, including subjects of experimentation in private for- profit in vitro clinics under that same protection. Thank you.

UNIDENTIFIED MALE: I'd like to comment on the extraordinary number of women's eggs that would be necessary should this procedure succeed. I mean, several people, Senator Landrieu made that, Ms. Norsigian made that, and I'd just like to emphasize one point. In the beginning, we will need eggs obtained in the way she described because we may, in fact, learn how to create these kind of embryonic stem cells without having to use eggs, but by learning what factors in the eggs are, in fact, activating the nucleus, which is introduced into the egg cell.

If tomorrow I discovered how to convert a fiberglass skin cell, which I've grown in culture for years, if I learned how to transform that into some ball of cells, which contains stem cells, I then should I guess, would somebody define that as an embryo? It was my skin cells growing in culture, transformed by some unknown process, inadvertently perhaps, which now creates embryonic stem cell like properties. That's not an embryo by my definition or I hope anybody else's.

But the point I want to make is we know that there must be something in the egg cytoplasm that is able to activate the entering nucleus to reprogram it so it will recapitulate steps of embryonic development. I then should have guessed that there will be a huge effort to identify what those factors are in the cytoplasm, and we may be able to, in fact, recapitulate that whole reprogramming without needing an egg, and that's full research. That's what research is about. We pose questions and we have to do experiments in order to explore the possibility. We can't predict the outcome. Research is not determinative in that way.

KENNEDY: Doctor Newman.

NEWMAN: I would just like to respectfully add that we have plenty of mouse eggs with plenty of mouse egg cytoplasm. We have plenty of frog eggs with frog egg cytoplasm. Developmental biologists, people in my field, have been trying to figure out for a long time, have made some progress, what there is in that egg cytoplasm that will make a cell turn into many different cell types, where only a little bit of the way there, we have years and years of research on these animal models to even really be confident that we know what we're doing.

And to imagine that this is an appropriate area for doing research on human women's eggs, the many eggs from human women to take the cytoplasm of those eggs, we're just so far from that being a feasible line of research to use human materials for, that it just, to me it doesn't make sense at all.

I just want to add one other thing, concerning those places where none of us will go. Everybody in this room has said, none of us wants to clone a full-term human being. Doctor Murray said we shouldn't go beyond 14 days with the embryo. But in fact, there are plenty of people out there, doctors, scientists, bioethicists, that say why not try full-term human cloning.

If it's not just confined to the debate in this room, there are people in private clinics that would like to do it. There are religious groups that feel it's their mission to do it, and this technology will develop if embryo cloning goes ahead with federal funding under the auspices of American science to enable those irresponsible people that do want to do full-term cloning to do it.

KENNEDY: Any other last word. Yes, Doctor Murray.

MURRAY: There's actually one group that we know of, and depending on whether it's advantageous to be declared a religious group or not, they declare themselves to be a religious group or not, these are the (inaudible) who claim that that's their mission in the world. They have shown no evidence that they have the competence to come near. Yes, Doctor Newman's right, there are people who will do anything. There are people who will kill, murder, steal, embezzle, and (inaudible) a company. There are people who will do anything, and we should pass a law to make it, to punish those people and make it that much more difficult and frightening for them to try to create even a child by cloning. But I don't think that the fact that there are some people out there who are talking about it is reason to feel that that's a line we're likely to cross in the near future.

KENNEDY: Senator Jeffords, I'm afraid I have to leave. I have to catch a flight back.

JEFFORDS: I'm going to let you all go. I just want to say that this is the first time I've ever had 200 people listening to me or the committee here for this rather lengthy time, and with it being also on the TV, I can imagine that you have been visiting with a good many thousands, if not millions of people, and I can't commend you enough for how articulate and well you expressed yourselves, and you certainly allowed your differences not to get anybody frowning at me right now anyway. And so, thank you so much.

KENNEDY: You have the last word.

BERG: Well, Doctor Berg, one issue we didn't develop and I know you need to run and we don't need to ask you the question now, but I'm going to submit it to the record. It seems to me that there are three arguments for therapeutic cloning.

First, this basic understanding of human development and life, science, pursuit of knowledge. The second is this immunogesity (ph), which actually Mr. Reeve - I think we need to clear that up, because I think there are some misconceptions how important that is, and we need to address it. It's important, but as you know, with mitochondrial DNA, it's not perfect genesity, and I've been dealing with this a long time in heart transplants, lung transplants and neo-suppression.

That's what I do, and the oversimplification that this is going to cure it all is false, and it is irresponsible for any of us to come out and give hope to people that this is going to cure that problem. Not that you've done it, but it's one of the three arguments that are out there. Basic human life, understanding at those earliest stage, which obviously I'm in support of. The question is ethically should we dive into it. The second is this immunogesity (ph) and I'll put a question on the record, but we need to make that a part of this record.

And then the third is the supply issue, you know, in terms of do you need really to do cloning, this aspect of it to have enough cells or the tools that it provides to help in terms of the research. But I will say that, because I know you want to close the hearing now to address the - and I will put it in writing as we go forward.

KENNEDY: Thank you very much.

UNIDENTIFIED MALE: We reserve the right for the next 14 days to again ask you for questions, or any member of the committee does, but don't wait by your mailbox. Thank you all.

KENNEDY: Thank you all. That was great.

END

NOTES:
[????] - Indicates Speaker Unknown
   [--] - Indicates could not make out what was being said.[off mike] - Indicates could not make out what was being said.

PERSON:  EDWARD M KENNEDY (94%); TOM HARKIN (57%); PAUL DAVID (56%); JEFF BINGAMAN (56%); JAMES JEFFORDS (56%); PATTY MURRAY (55%); JACK REED (55%); JOHN EDWARDS (54%); JUDD ALAN GREGG (54%); HILLARY RODHAM CLINTON (54%); TIM HUTCHINSON (53%); JOHN W WARNER (52%); CHRISTOPHER (KIT) BOND (52%); PAT ROBERTS (52%); JEFF SESSIONS (51%); SUSAN M COLLINS (51%); 

LOAD-DATE: March 10, 2002