HEARING ON STEM CELL RESEARCH

Headline: U.S. SENATOR TOM HARKIN (D-IA) HOLDS HEARING ON STEM CELL RESEARCH

WITNESSES

PANEL I
ELIAS ZERHOUNI, M.D., DIRECTOR, NATIONAL INSTITUTES OF HEALTH
PANEL II
CURT CIVIN, M.D., DEPARTMENTS OF ONCOLOGY AND PEDIATRICS, JOHNS HOPKINS UNIVERSITY
GEORGE DALEY, M.D., PH.D., WHITEHEAD INSTITUTE, MASSACHUSETTS INSTITUTE OF TECHNOLOGY
ROGER PEDERSEN, PH.D., DEPARTMENT OF SURGERY, CAMBRIDGE UNIVERSITY
GERALD SCHATTEN, PH.D., DEPARTMENT OF CELL BIOLOGY-PHYSIOLOGY, PITTSBURGH DEVELOPMENT CENTER, MAGEE-WOMEN'S RESEARCH, INSTITUTE


SPEAKERS:

U.S. SENATOR TOM HARKIN (D-IA)
CHAIRMAN
U.S. SENATOR ERNEST HOLLINGS (D-SC)
U.S. SENATOR DANIEL INOUYE (D-HI)
U.S. SENATOR HARRY REID (D-NV)
U.S. SENATOR HERB KOHL (D-WI)
U.S. SENATOR PATTY MURRAY (D-WA)
U.S. SENATOR MARY LANDRIEU (D-LA)
U.S. SENATOR ROBERT BYRD (D-WV)

U.S. SENATOR ARLEN SPECTER (R-PA)
RANKING MEMBER
U.S. SENATOR THAD COCHRAN (R-MS)
U.S. SENATOR JUDD GREGG (R-NH)
U.S. SENATOR LARRY CRAIG (R-ID)
U.S. SENATOR KAY BAILEY HUTCHISON (R-TX)
U.S. SENATOR TED STEVENS (R-AK)
U.S. SENATOR MIKE DEWINE (R-OH)


SPECTER: The hour of 9:30 having arrived, we will proceed with the hearing of the Appropriations Subcommittee on Labor, Health, Human Services and Education. Our purpose today is to examine the status of implementation of the president's policy on stem cell research.

This is the 14th hearing of the subcommittee. Shortly after stem cells came upon the scene, the subcommittee held hearings in December of 1998. And this is our 14th hearing in following up on this very, very important field of medical research. The unique opportunities for stem cells is recognized in a wide variety of ailments. And it has been a controversial matter because the stem cells are extracted from embryos. While there are other stem cells , our hearings have disclosed that the embryonic stem cells are the most useful.

And the opposition is focused on the consideration of life being produced by the embryos. And if they could all produce -- each embryo could produce life, that would obviously be the highest calling. But we know that thousands are thrown away.

So that it is my view that it is obviously preferable to use these embryos to save lives, as opposed to discarding them.

The president last year established a policy limiting stem cells to 63 or 67 lives, in that range. And a big issue arises as to whether that is adequate to carry on the research.

During the course of the past year, we have had a considerable controversy over nuclear transplantation, which some people call therapeutic cloning, which is not cloning at all. But this is a matter which is surrounded by controversy. And I think we have to find our way through because, at least in my view from the 14 hearings we've held, is that it poses an enormous opportunity to conquer disease.

That's a relatively short opening statement to set the parameters. The majority leader has scheduled two votes at 10:30, which means that the hearing will have to be adjourned for up to 30 minutes. And I'm going to do my best to move through the hearing and conclude by 10:40. I'll be a little late for the first vote, but I think that's a preferable scheduling than to have witnesses and observers wait a half an hour in mid-morning. I know how busy the people are who are at the hearing as witnesses and also as observers.

Our first witness is Dr. Elias Zerhouni, the director of the National Institutes of Health. He comes to this position with a very extraordinary record.

He was executive vice dean in John Hopkins University School of Medicine, chair of the Russell H. Morgan Department of Radiology and Radiological Science and Martin Donner professor of radiology and professor of biomedical engineering. Dr. Zerhouni received his medical degree from the University of Algiers School of Medicine.

He came to this country at the age of 24 and has had a really remarkable career; had his residency in diagnostic radiology at Johns Hopkins. I've already had considerable contact with Dr. Zerhouni in his first four months on the job. And this is his first appearance before the subcommittee.

We welcome you here, Dr. Zerhouni and look forward to your testimony.

ZERHOUNI: I am pleased to be here this morning and testifying about the role of NIH in advancing the field of stem cell research. We all know that if properly harnessed, adult and embryonic stem cells have the potential to replace cells that are damaged or diseased, to restore vital function to the human body.

There are ample reasons for excitement. I personally thought that this was a field that needed to grow when I was at Johns Hopkins. There is no question that there is huge potential and promise. And high expectations for the new treatments that are possible with this approach are understandable.

But we should temper these expectations by the enormous challenges that must be addressed before the research evolves into proven therapy. I think we're at the very early stage of research in embryonic stem cell research and have a great deal of basic research to conduct before we can unlock the potential of these cells.

What I'd like to do, to go over my presentation, is to use some charts to my right, to go over what the basic strategy for research and research development will be in stem cell research, whether adult or embryonic. And we can divide that strategy into three phases.

There is an early phase called a basic research phase and then two follow-on phases called pre-clinical and clinical phase. The most important aspect of the basic research phase is for us to build the scientific capability of the field by creating career development pathways training courses. The most important resource for any new field are trained investigators who are entering the field and advancing the field.

We need to establish an infrastructure with cell culture methods, cell lines, expand the cell lines, characterize the cell lines. The puzzle has to come together then, in terms of us being able to both prove the long-term stability of these cells .

We need to characterize them fully. And we need to make sure they are genetically stable.

We need to understand the basic reason why we are so excited about stem cells is that they can differentiate and specialize into different cells in the human body. We need to understand that better.

At the most fundamental level, how is that done? What are the methods that we need to develop to understand this at the gene level and the molecular levels?

We need to understand how the cell cycle of the stem cell is controlled. One of the major risks in stem cell research is that these cells, once implanted, will revert to their more undifferentiated state and could grow into tumors. We need to understand that.

And last, but not least, we have to have a lot of research go on in understanding the interactions between the cells and the host and the immunology and the transplantation biology of these cells . As we progress, other elements of research will have to come into play.

And this year, we have had a lot of progress made. We've shown that, in fact, embryonic stem cells can differentiate into nerve tissue, insulin-producing cells. Adult stem cells have been shown to be also able to differentiate. And I believe that we should continue both embryonic stem cell and adult stem cell research at the same pace -- as fast as we can -- to grow into our understanding of the puzzle, that will then lead us to the pre-clinical phase.

So we need to have truthful concept experiments. We need to use the technology in animal models of disease. We need to prove what cell dosings we need to use, make sure that our understanding of tumor formation is complete, sense whether or not the cell is really functioning as we are supposed to make it function.

And eventually then, once we have accumulated that body of knowledge, go to the clinical phases of research, which are typically divided into three phases -- to test whether or not there is any toxicity; what's the safety of these cell lines; what's the efficacy of these cell lines -- to eventually go into therapies that will serve the public.

Now, I would like to also cover with you the work that NIH has done over the past year in trying to advance the field. There are two important elements enhancing the research is the institution in NIH that should look to implement the research agenda.

There are two resources that I consider the most critical right now. One is the availability of researchers. So what we have done is try to develop training capabilities for researchers across the nation.

We have tried to limit the shortage or decrease the shortage of researchers with expertise in stem cell research. We have extended additional grants to people who have expertise in stem cell research, but not necessarily in human stem cell research.

And we will strive to make stem cell research as attractive as possible to our most talented research scientists. So we're soliciting grant applications. And I will give you some of the data related to that in a minute.

One of the most important stumbling blocks is to making stem cells more available of research. As you know, on November 7, 2001, NIH published the registry of derived stem cells that would be eligible for federal funding. The registry consists of 14 sources across the world.

The cells are in various stages of characterization and preparation for research application. There are many steps required to develop embryonic stem cells from when they are first removed from an embryo and put into culture into an established, well-characterized embryonic stem cell line, ready for research, for distribution to the research community.

I tried to summarize this process right here in my chart on the left side to show you what is the exact process that we need to go through to make cell lines widely available for distribution. After the derivation and the culture -- hopefully, the culture of the inner cell matches, in primary colonies, which takes three to five days, the first thing we have to do is extend the primary colonies, then to put them into subculture wells.

Now we need to have enough expansion of these cell lines to be able to then have enough of them to be available for distribution. The test rate here is not very high. Only 10 percent of these subcultures eventually go on to establish lines that can be characterized as human embryonic stem cell lines.

There are about 30 to 60 passages then that have to occur to expand the number of lines. As the cells divide, the total number of cells available to us for research increases. At each passage, in stem cell biology, we need to make sure that these cells have not differentiated. And we need to have markers. We need to have ways of making sure that these cells still have the total potential of embryonic stem cells .

That is 30 to 60 times. And the expansion of these cultures is essentially the basis for the distribution that eventually occurs. It takes about six to nine months to get from this stage to the stage where you have expanded these subcultures successfully. You've characterized them successfully.

And one bank requires about two million cells for available -- to start to distribute these cells to the general public, you need approximately two million cells per vial to do so.

So the process obviously takes a while. And NIH has been very aggressive at, in fact, facilitating the availability of these cell lines from the derivations that were eligible for federal funding.

During the scaling up process, investigators need to repeatedly check that the cells maintain their ability. And once that's done, we can go forward with the distribution.

So as a first step toward overcoming this challenge, NIH announced five infrastructure grant awards, totaling $4.2 million, to five sources on the NIH registry, holding 23 of the eligible derivations. Two additional awards have passed through review and await final approval and funding within the next few weeks.

These awards will fund the expansion, the testing, the quality assurance and the distribution of the cells through the process I just explained. We're also working with stem cell sources to address the complex issues that might limit widespread availability of these lines; in particular, intellectual property issues.

In the past year, NIH has negotiated agreements with four stem cell providers to allow both our intramural researchers access to their cells and also to allow extramural researchers to have access to these cells. Under these four agreements, we have been able to receive six -- six intramural laboratories at NIH have received cells for research. And the agreements commit to the four providers, with whom we have signed agreements, to offer these cells under similar terms to extramural investigators.

Moore (ph), for example, which is the source that has been the first to be able to provide cell lines, has informed us that it has agreements in place with 111 researchers and has shipped cells to 74 of them. And these researchers represent 61 institutions, 12 of them in foreign countries.

Another source, ES Cell International, informs us that it currently has a supply of cells that far exceed current demand. We are still in active discussions with all sources to be able to provide additional cell lines.

We are receiving investigator-initiated research grant applications from new investigators. So far, five new grants, totaling $4.2 million, have been awarded. We have issued 32 administrative supplements to existing grant awards that will allow 30 researchers from 25 different institutions to incorporate research on the human embryonic stem cell as part of their ongoing, federally- supported research, which means that currently funded laboratories are extending their work to include human embryonic stem cells , which is a way for them to develop the skills and expertise needed in the field.

SPECTER: Dr. Zerhouni, I'm reluctant to interrupt you, but if you could sum up now, we would appreciate it.

ZERHOUNI: I will.

I formed a Stem Cell Task Force as soon as I arrived at NIH. And the reason I did was because I felt it was very important for NIH to promote this field as fast as we can, both in terms of embryonic and adult stem cell research.

I have appointed Dr. Jim Batte (ph) as head of the Stem Cell Task Force. And I am looking forward to continuing, as rapidly as we can, the development of this research.

SPECTER: Thank you very much, Dr. Zerhouni. A little more time was allowed for your presentation because of the importance of what NIH is doing and setting the stage for our other witnesses.

Since there are two votes, as I had said earlier, at 10:30, we're going to proceed now. If you'd keep your seat, Dr. Zerhouni, to hear from the other five panelists. And then we will proceed to questions.

So if Senator Deborah Ortiz would step forward, along with Dr. Civin, Dr. Daley, Dr. Pedersen and Dr. Schatten, we will hear your testimony.

Our first witness on this panel is Senator Deborah Ortiz, elected to the sixth state senate district in California in November 1998. She is the chair of the Senate Health and Human Services Committee and is also a member of the Education, Budget, Public Employment and Retirement and Natural Resources and Wildlife committees.

She received her undergraduate degree from the University of California Davis and her law degree from the McGeorge School of Law. As noted earlier, if we don't conclude by 10:40, we'll have about a 30-minute break for the votes. So we're going to try to proceed to conclude at that time.

Since Senator Harkin could not be here today, he is the chairman. And I am ranking. We traded positions. Last year, Senator Jeffords arranged that.

(LAUGHTER)

We have had a very close collaboration. And as far as the operation of this subcommittee is concerned, it doesn't make any difference whether Senator Harkin is the chair or I am. We have worked that closely.

Senator Ortiz, thank you very much for coming all the way. We look forward to your testimony. This is the clock showing five minutes, so to sum up and stop.

ORTIZ: Wonderful.

Thank you, Senator Specter, as well as other members of the committee. I thank you for inviting me here. And I'm very conscious of running the committee on time, so I'm going to pull out my watch and try to adhere to the five-minute rule as well.

Thank you for inviting me to join you today at today's hearing as you consider the very important question and the task of examining the implementation of President Bush's stem cell research policy and the impact of that policy on the development of stem cell technology.

Let me begin by sharing with you why California found it imperative to move forward on stem cell research.

In order to do so, let me share with you my personal history. I served as the assemblywoman and was elected to the state assembly in 1996. As I was transitioning in my newly elected position as assemblywoman, my mother had been diagnosed with ovarian cancer.

And I took very seriously the task of saving her life. And as I did my research and her disease progressed, I began to understand that, as important as chemotherapy and treatments like chemotherapy are in the lives of millions of cancer patients and the families who take care of those individuals, I knew that the next level of cure for cancer, as well as all the other diseases that we are all absolutely to committed to curing and improving the quality of life, that the real cure really resided at a very basic level in the research and that stem cell research is offering that promise.

California began to see that when President Bush declared the August 2001 64 line limitation for use and access to federal dollars, I decided that I was going to try to have California move forward. And it became even more compelling this last spring as we began to see a couple of competing measures move through Congress.

The Brownback bill posed the greatest concern to California, not just in its limitations and its criminalization of science and medicine, but also in the likelihood that there would be some success in his closing the door to science and technology and preventing the delivery of that promise to all of those Americans -- over 100 million -- who suffer from these diseases.

We also saw Senator Feinstein's work. And I thank the members of this committee for having offered a nonpartisan debate about a very important policy issue.

And we were hopeful that that bill would, indeed, become law and would preclude the Brownback bill from becoming law. That was not to happen.

So as we moved forward in California, I hosted two significant hearings, one in Stanford, with the brightest and most brilliant of minds. And Dr. Pedersen, to my right here, was good enough to videotape his testimony and welcome us from England and share with us why he left the United States in order to pursue the science that we all hope to achieve in California.

And out of that hearing at Stanford, we decided to move forward and go to the Salk Institute and also have a hearing, in which Hans Keirstead, who is doing some incredible research in Irvine, in California, demonstrated the mice whose spinal columns have been severed, in which the introduction of stem cells produced movement and function in the lower limbs of those mice.

We also heard the testimony from Jerry Zucker, the father of the 14-year daughter with juvenile diabetes, who shared with us his hope that his daughter would be able to live to see adulthood and not spend her life on dialysis and ultimately die at a very early age.

California decided to move forward in this research. I introduced the bill that would legalize in California stem cell research with the appropriate ethical and IRB review, as well as prohibitions for sale and transfer of embryos.

When we broadened that commitment to curing cancer, we acted decisively to pursue stem cell research in California. My law that the governor has now signed has made, for all intents and purposes, the Bush policy on stem cell research irrelevant in the state of California.

California will move forward to cure cancer, as well as Alzheimer's, as well as ALS, as well as Parkinson's, juvenile diabetes, address the spinal cord injury challenge and day-to-day realities of persons who live with those injuries. And we will move forward.

And we hope to share those therapies and that medical science and improvement with the rest of the country. We ask that Congress respect California's will to protect Californians and assure that that right will be protected and not preempted by any subsequent federal law.

California is moving forward because we understand our responsibility to pursue technology that promises to cure or effectively treat over 100 million Americans. To commit the necessary resources to deliver that hope, we have an unavoidable obligation to do everything we can do to realize potential of stem cell research.

Once again, California is moving forward. We ask you to respect that. we believe that the Bush policy is not only medically and scientifically unsound, it is simply irrelevant in the state of California.

Thank you.

SPECTER: Thank you very much, Senator Ortiz.

We turn now to Dr. Roger Pedersen, a leading stem cell researcher, had been at the University of California in San Francisco until September of last year. And at that time, Dr. Pedersen decided to relocate to the University of Cambridge, where he had received government funding for his research on human embryonic stem cells .

Currently, Dr. Pedersen's research is supported by the United Kingdom Medical Research Council and the Welcome Trust. He received his Ph.D. in biology from Yale.

And we very much appreciate your coming a long distance to join us. And your own views and insights and the necessity for your moving out of the United States is a matter of grave concern and is obviously a factor in determining what our policy should be as to stem cells .

Dr. Pedersen, the floor is yours.

PEDERSEN: Senator Specter, thank you very much for the opportunity to speak. As you know, until this time last year, I worked at the University of California-San Francisco, where I had been a faculty member for the previous 30 years and where we derived two of the novel embryonic stem cell lines on the NIH registry early last year.

I now live and work in the United Kingdom, where I am engaged in stem cell research at the University of Cambridge. In addition to having responsibilities for my own research team in the Department of Surgery there, I lead a consortium of 25 researchers, who are focusing their individual groups on various aspects of stem biology and medicine.

I also provide advice to other administrators and scientists in the United Kingdom who are guiding the development of the U.K. stem cell enterprise.

I'd like to add my enthusiasm for how exciting this is as a time for stem cell researchers. We're building on more than 20 years of experience using mouse embryonic stem cells for genetic studies and on even greater experience using human blood stem cells for clinical treatments.

This has provided a foundation for the successful culturing of human embryonic stem cells and opened the opportunity to control the development of human cells in the laboratory into forming a variety of useful tissues. Importantly, we now have evidence, as Dr. Zerhouni has mentioned, from NIH researchers that mouse embryonic stem cells can be cultivated to produce insulin in mice and to alleviate, in other studies, the symptoms of Parkinson's in rats. These advances in stem cell biology raise our expectation for clinical benefits from stem cell medicine.

All of us know of a courageous person like Christopher Reeve who could benefit from such novel therapies. For me, it was my mother, who died of diabetes in 1989, yet still provides me with an enduring will to help people with that disease. How can we achieve the clinical promise of stem cell research on their behalf?

Against these expectations, the pace of discovery of human embryonic stem cells seems painfully slow. The lack of any federal support for research on human embryos, stretching all the way from 1978 to the present day, has undoubtedly delayed the benefits of research to infertile patients. And the long wait for federal funding to support stem cell research has, I think, equally delayed the benefit of research to patients with the degenerative diseases.

I admit to having been frustrated myself with the length of time we had to wait for federal funds for stem cell research. Admittedly, the establishment last summer of an NIH registry of human embryonic stem cells eligible for federal funding was a significant first step in advancing such research.

However, given the length of time required to build a successful research program, any concern on the part of researchers for worsening in the present U.S. policies for stem cell funding would tend to keep perspective researchers on the sidelines. Such concerns would definitely undermine efforts to recruit additional researchers, particularly junior investigators, into the field.

It would be particularly devastating if the U.S. Senate moved to criminalize the use of somatic cell nuclear transfer to generate immune matched stem cells . And in this respect, it's very good to see my home state in California has made clear its position in support of this and all other aspects of stem cell research.

How could the federal government do a better job of supporting stem cell research? First, let me offer my respect for the will and perseverance that the NIH has shown during the last decade in their desire to support the fields of human embryology and embryonic stem cells . I believe that their approach of building up the research infrastructure by supporting training of researchers and the standardization, characterization and distribution of the human embryonic stem cell lines on the registry will prove to be a wise one for this country.

I'm not convinced that it is necessary to convert the present decentralized stem cell bank to a centralized repository. Rather, I think that such a move by the NIH would lead to additional delays in the accessibility of cell lines. Therefore, my advice to them is to hold their present course.

But the truth is that the federal government as a whole must make a far larger commitment in order to realize the larger promise of stem cell medicine. New embryonic stem cell lines must be derived and characterized in order to meet current tissue standards for transplantation.

Extensive studies are needed to define the conditions for generating large numbers of stem cell types from stem cell lines. Pre-clinical studies in animals, including not only rodents, but also non-human primates, will be essential.

And finally, careful clinical trials in appropriate patient populations will be needed to prove the efficacy of stem cells as medicines. This will all take some years to achieve. I don't believe that miracles that endure happen overnight.

To sum up my views, I believe what is needed is a long-term U.S. commitment to develop the public policies and to sustain the public funding that will make the stem cell dream come true. Why should we regard the ravages of disease as inevitable? If there is a war to be fought, surely it is against the presently untreatable diseases, which kill thousands of people each day of the year.

To mount an effective campaign against such diseases will require a coordinated international effort that harnesses the strengths of each country. Any abdication on this front will likely cede the present U.S. leadership in the field of stem cells to Europe, Australia or Asia, together with the economic benefits, which will flow toward those countries that invest early and consistently in stem cell biology.

In closing, senator, I'd like to take this opportunity to thank you and Senator Harkin for your enduring support for this field, not only for stem cell biology and medicine, but also for all those who suffer from diseases. Thank you for hearing my views.

SPECTER: Thank you very much, Dr. Pedersen.

Senator Murray?

MURRAY: Mr. Chairman, I'm sorry to interrupt. I was hoping -- I have to get to another markup. And if I could just ask Dr. Zerhouni one really critical question.

SPECTER: Of course, Senator Murray. Proceed.

MURRAY: I really appreciate your holding this hearing. I think many of us were very concerned about the president's decision to limit stem cell lines a year ago. And watching, it seems like California has now moved ahead on this and are very concerned what will happen in our states with perhaps a drain of researchers and where that will go.

But I just wanted to quickly ask Dr. Zerhouni if state funds are used for embryonic stem cell research, will researchers in California or any other states that enact laws like this receive NIH funds in the future? Or will they be prohibited from receiving those funds?

ZERHOUNI: No, they can receive NIH funds if they work on the eligible cell lines that the present policies identified as eligible for federal funding. There will be no problem. And we have put in place the appropriate steps so that an investigator could work with federal funding on eligible cell lines and work with state funding on other cell lines, as desired.

As currently allowed, it is no change from what we have today.

MURRAY: Okay. Thank you, Mr. Chairman. I have a number of other questions I'd like to submit for the record.

SPECTER: Of course, Senator Murray. They will be accepted for the record. And responses will be made.

Dr. Pedersen, let me thank you for your good words for Senator Harkin and myself. We had set upon a program to double NIH funding. We have moved it from $12 billion to $23 billion.

This year, we have in our budget $3.7 billion in addition. But there has to be a bill. And so far, we're not having any legislation come out of the appropriations process. And if we are to have a continuing resolution, that means that the funding will probably stay level.

And that will be very, very bad for many projects, but especially for NIH, where we will have done more than the doubling, which we had anticipated. From $12 billion, it would put us to $26.7 billion. So I make that comment at this time, so that all of those here can use your lobbying influences to help us get a bill. And if you want a more particular roadmap, I'd be glad to talk to you later.

We'll turn now to Dr. George Schatten, deputy director of Magee- Women's Institute and Director of the Pittsburgh Development Center, professor and vice-chair of obstetrics, gynecology and reproductive science and cell biology at the University of Pittsburgh School of Medicine; received his Ph.D. from the University of California at Berkeley.

We're glad to have you in Pennsylvania, Dr. Schatten, because I've worked with you. It seems to me we've got a very heavy California influence here today.

(LAUGHTER)

The floor is yours.

SCHATTEN: Thank you, Senator Specter. And it's a great pleasure for me to have this opportunity to speak with you.

The NIH deserves tremendous commendations for their efforts and rapid implementation this past year. But serious and substantial work remains.

From my own experiences, I need to voice grave concerns about the current federal stem cell policies because it's already hindering invaluable research, undermining the wisest investments and delaying the day when we'll know -- know for sure -- whether human embryonic stem cells can be used to treat diseases.

The NIH's registry lists 71 lines. Science reports only 16 are available. My search has identified just a handful. As of last Thursday, we have just two.

We need accuracy and clarity. Perhaps 71 lines do meet eligibility criteria. But just being eligible isn't the same as available.

To obtain approved lines, I've traveled to Europe and Asia to collaborate with scientists in Korea, Singapore, Australia, Sweden and the U.K. They're willing and motivated. But shouldn't American science also be conducted on American soil?

NIH has sponsored my research for the past 25 years. And we investigate how fertilization succeeds and how the embryo develops.

Last November, we were among the first to apply to investigate how human embryonic stem cells divide and proliferate. When cells lose chromosomes, they can develop into cancers. If human embryonic stem cells lose chromosomes, when they're put into a patient's body, as Dr. Zerhouni mentioned, they could develop into cancers.

Chromosome movements in human embryonic stem cells must be accurate. And that's just what we're doing in our laboratory.

Researchers at the Pittsburgh Development Center of Magee-Women's are discovering that embryos form very differently between the mammals cloned successfully by somatic cell nuclear transfer and primates, as investigated in monkeys. Cloned cows and mice can develop without any sperm contributions; whereas primates in which all somatic cell cloning attempts have failed so far appear to depend on a unique complementation between the egg's machinery and the sperm's special structure.

Reproductive cloning in humans is dangerous, unethical, unjustified and, from biological purposes, we would predict that it will fail. Therapeutic cloning, on the other hand, in which embryonic stem cells are produced in a plastic dish in the absence of any sperm or any fertilization event promises unique methods to overcome our body's own immune rejection systems.

The editorial this week in "Science" entitled, "Harmful Moratorium on Stem Cell Research" is authored by some of the hand- picked members of the president's own Bio-ethics Panel.

Last April, NIH modestly funded our proposal for just a year. These supplements are insufficient in time or amount for the best research programs to justify redirections. The NIH must be more aggressive in supplementing investigator-initiated grants with significant funding.

Cooperative agreements would enlarge the talented pool. New equipment is necessary to ensure the separation of stem cell research from ongoing activities. Labs selected for multiyear awards should also be responsible for research training. Commercial-academic cooperations also need to be encouraged further.

On Sunday, I met with Lansing Taylor, who is CEO of the Pittsburgh-based company Cellomics. He has mocked up human embryonic stem cell pluripotency kits and assays to determine whether these lines will develop into neurons.

Other companies could further reduce the hurdles very swiftly if they were encouraged to jump into this field and reduce the research hurdles.

During this hearing, we've discussed national policy and contrasted it with stem cell rules elsewhere. We're the United States. And each state has its own laws and restrictions that may prove enabling or restrictive.

Senator Specter, you know well that our Commonwealth of Pennsylvania has language restricting human embryonic stem cell research. The Abortion Control Act of 1989, written long before stem cells were discovered, prohibits embryonic research.

Homeland Security director Tom Ridge, while still governor of Pennsylvania, decided that cells derived outside of Pennsylvania were eligible for research within our Commonwealth. We've heard just now from Senator Ortiz that California is enacting laws to enable human embryonic stem cell studies.

It may be within this subcommittee's purview that, in addition to witnessing American scientists emigrating, we may soon see U.S. scientists relocating from states with ambiguous laws to other states.

Senator Specter, subcommittee members, I applaud you and others in Congress for your unwavering support of the NIH. Your sponsorship and encouragement of healthy federal and private sector competition produced the human genome sequence under budget and far sooner than expected.

When we decided to decipher the genome, which also generated controversies, we deliberated thoughtfully and invested adequately. More and better lines are needed now. And current policies are already delaying stem cell research, forcing it offshore or into inaccessible reaches in the private sector.

Would Galileo have been satisfied if he could have looked at 65 or 71 stars? Maybe. But he wouldn't have discovered our place in the solar system unless Jupiter traveled through that narrow field.

In today's terms, the cost of the Hubble Telescope and all of NASA is the same if our focus is restricted or if we're permitted to explore the heavens. Thank you.

SPECTER: Thank you, Dr. Schatten.

Dr. Schatten, you're safe in Pennsylvania. Don't move.

(LAUGHTER)

We turn now to Dr. Curt Civin, (?) professor of oncology at Johns Hopkins University, where he developed a stem cell selection process which has led to the development of more effective and less toxic cancer therapies. Dr. Civin holds nine patents for biomedical inventions related to stem cell research, received his MD from Harvard Medical School.

Thanks for joining us, Dr. Civin. And we look forward to your testimony.

CIVIN: Thank you, Chairman Specter, Senator Hutchison, Senator Ortiz. Thank you for the honor of testifying before you today. I'm very grateful for your strong -- this committee's strong and consistent support for lifesaving biomedical research.

It's also a special privilege for me to testify today with my friend and former Johns Hopkins colleague, Elias Zerhouni. Our nation is indeed privileged to have a scientist of his distinction and capability serve as NIH director.

I am professor of cancer research of the Johns Hopkins University School of Medicine, where I hope to stay. My clinical specialty is caring for children with cancer. And this motivates my research.

For the past 23 years, I have studied adult stem cells , mainly human bone marrow stem cells that can reconstitute our blood and immune systems. I discovered the CD34 stem cell molecule that allows identification and isolation of these rare blood-forming stem cells .

The discovery is widely used in stem cell research and in clinical transplantation, bone marrow transplantation. And two companies have licensed related inventions.

And so I want to disclose to you that Johns Hopkins University and I have a financial interest in certain stem cell inventions and medical therapies.

Today, my research continues to focus on adult stem cells . We need to figure out how to grow these stem cells easily and in large numbers so that, for example, a bone marrow donation from one single donor can provide enough stem cells for multiple transplant patients.

The 1998 discovery of human embryonic stem cells significantly raised our hopes of solving this therapeutic problem. By studying these cells , we hope to discover the molecular pathways by which they can proliferate without differentiating and then figure out how, in effect, to push the same molecular buttons in adult stem cells .

Such discoveries would enhance the treatment of my cancer patients and might also help in the development of stem cell regenerative medical therapies for the range of other diseases.

President Bush's decision to allow federally funded research on a qualified number of human ES cell lines increased our hopes of advancing this research. The decision has, however, proved much more limited than we anticipated. More than a year after the president's announcement, I am still waiting to receive my very first stem cell line.

In fact, embryonic stem cell research is crawling like a caterpillar. Few human embryonic stem cell lines exist. And most are not truly available.

A number of the lines on the NIH stem cell registry have been tied up in questions of ownership. Many of the owners of the not-in- dispute cell lines are not anxious to share them with other researchers.

Those that are willing to share their lines expect a piece of the profits on future discoveries. The terms of material transfer agreements are often difficult and time-consuming to negotiate. The owners also expect an upfront fee. The going rate is $5,000, an amount 50 to 100 times greater than what we are accustomed to paying for a cell line.

Besides these administrative burdens, there are significant technical challenges as well. Little is known about the cell lines themselves. Without this information, individual researchers are essentially flying blind. We must characterize the cell lines ourselves, an extraordinarily inefficient use of limited resources.

An example: last fall, a colleague applied to receive the best studied of the cell lines on the initial NIH list, the H1 cell line from Wisconsin. Six months later, he received the cells. It took him more than four months to grow enough ES cells to perform even preliminary experiments. These cells grown exceedingly slowly -- one tenth of the rate of the cells we usually work with.

For my research, I need several ES cell lines, since I'm sure that not all will form blood cells or will grow rapidly. Last fall, I was contacted by a company in India which owned seven of the embryonic cell lines on the NIH registry.

They wanted to collaborate with my lab to explore the blood forming potential of these lines. I spent several months negotiating collaboration and materials transfer. But the imminent agreement was abruptly cancelled in May. The company told me that the Indian government had put an indefinite hold on sending ES cell lines out of their country.

In July, I applied for a different ES cell line from Wisconsin that is reported to grow somewhat faster than H1 and to form some blood cells. I have been told that because of technical problems with these cells , I will not receive them until October, at the earliest.

Stem cell research has tremendous potential to deliver treatments and cures. With research, we can make stem cells that are self- renewing, that are less likely to be rejected by the recipient's immune system and that regenerate tissues and organs fully.

Today, the U.S.A. is the best place in the world to do all biomedical research. I don't want us to lose that lead in stem cell research. And we are really in danger of doing so.

Without our vigorous leadership in federally supported research in this country, the worldwide pace of discoveries will be much slower than necessary. Instead of being the first in line to benefit from new treatments, as they are now, our patients in America will have to wait.

We will lose talent to other nations, as you have heard. And new jobs and industries will be spawned elsewhere.

Every week, we read about exciting new stem cell research underway in other countries. Prime Minister Tony Blair of the U.K. recently says he wants Britain to be the best place in the world for stem cell research. Singapore has invested $1.7 billion.

I am heartened by Dr. Zerhouni's recent creation of the NIH Stem Cell Task Force and look forward to its contributions. Much work needs to be done.

Mr. Chairman, I am also again grateful to the subcommittee for including language in your FY 2003 committee report directing NIH to take positive steps to stimulate research. Specifically, I would strongly endorse your language, urging NIH to develop a stem cell repository. A repository would promote research and lower the barriers to obtaining stem cell lines for investigators like me.

Under this arrangement, NIH would characterize the lines and then act as a technical resource and distribution center. This would eliminate duplication of effort and provide an invaluable technical resource for growing the cells .

Once again, I want to thank you for your commitment to biomedical research and for your assistance in clearing unnecessary impediments to progress. You have really made a difference. Thank you.

SPECTER: Thank you very much, Dr. Civin.

Our next witness is Dr. George Daley, assistant professor of medicine at Harvard University's Whitehead Institute, where he studies stem cells of the blood. His research has helped to find the molecular basis for human leukemia and provided insights into normal blood development.

Prior to this appointment at Harvard, Dr. Daley served as chief resident in medicine at Massachusetts General Hospital. His Ph.D. is from MIT and his MD is from the Harvard Medical School.

Welcome, Dr. Daley. We look forward to your testimony.

DALEY: Thank you, Chairman Specter, distinguished members of the subcommittee. My name is George Daley. I'm a faculty member at Harvard Medical School. And I run a research laboratory at the MIT- affiliated Whitehead Institute that studies stem cells that the body uses to form blood.

This has prompted our intense interest in using human embryonic stem cells for our research. My laboratory currently holds NIH grants to support research on both mouse and human embryonic stem cell biology. My laboratory has spent the last seven years using mouse ES cells to investigate how blood cells develop in the petri dish. Recently, our group has taken a step forward.

We successfully transplanted mice with blood stem cells derived entirely from mouse embryonic stem cells . Then, in collaboration with my colleague Rudolph Yenish (ph), we performed an important first demonstration of therapeutic cloning to treat a mouse with a genetic immunodeficiency, similar to the "Bubble Boy" disease.

Our team plucked a cell from the tail of an afflicted mouse, used nuclear transfer to create an ES cell line, used gene therapy to correct the genetic defect and then performed blood stem cell transplants into diseased mice. The repaired ES cells provided a source of immune cells and antibodies in the treated mice.

Encouraged by this first proof of principle in an animal model, my team is eager to apply the same strategy to human ES cells . Our hope is that one day, the process will be efficient, safe and effective for treating patients with a variety of genetic and malignant bone marrow diseases.

However, over the past year, the progress of my own team --and I would say that of the research community in general -- has been palpably slowed, in part because of the frustrating lack of access to human ES cells and in part due to the restrictive nature of the president's funding policy, as mandated in his address of August 9, 2001.

I wish to make three points. Fist, the biomedical research community needs more cell lines. While the president announced that over 60-odd lines were available, it has become increasingly clear over the past year that far fewer lines have been characterized adequately -- perhaps, only a handful.

Second, the research community needs a central repository for ES cell lines, preferably in a facility funded by NIH, that would provide free access to a comprehensive set of carefully maintained and documented lines for research.

And third, I wish to emphasize that the federal funding guidelines are currently so restrictive that they are already threatening, yet highly promising field of research.

First, my personal experience. My team was one of the first in the U.S. to gain access to the ES cells that Jamie Thomson and his colleagues derived at the University of Wisconsin. However, since obtaining that single cell line in mid-2000, we've been frustrated in attempts to obtain another.

One week ago, after nearly two years of increase with a number of other research groups, we finally received our second line. Why did it take so long? Well, the number of laboratories interested in working with these cells is increasing explosively.

This dictates that a more effective means must be established for the distribution of these valuable reagents. I believe that a central warehouse and processing facility should be established and funded by the NIH. A central repository would maintain consistent, standard operating procedures for the culture and maintenance of the cell lines.

Finally, I want to comment on the state of research on human embryonic stem cells after a year under the policy announced by President Bush last August. I would applaud President Bush for his principled stance in favor of human ES cell research. Having access to even a few well characterized human ES cell lines enables us in the research community to begin to address generic questions about ES cell biology.

However, this is only the beginning. And the current policy will not enable the research community to follow through with the work needed to treat patients.

President Bush made the right call in allowing federal funding for research. But his policy excludes some of the most important and promising new avenues.

As I have stated, it is unclear precisely how many cell lines exist. But I strongly believe that the number is far fewer than listed on the NIH registry.

Second, the president's policy does not allow support for deriving new cell lines, which is of tremendous scientific interest. And my last point, the president's policy does not allow for studies of ES cell lines derived by nuclear transfer. This is currently the most appealing avenue for creating ES cells from patients with specific diseases and for creating ES cell lines that are genetically matched to patients.

Our research teams showed that nuclear transfer methods can be applied in the practice of therapeutic cloning in mice. I have no doubt that legitimate and successful medical treatments in real patients will be developed sooner if the federal government funds nuclear transfer studies with human ES cells , starting today.

The sad and undeniable truth is that the existing restrictions are keeping these advances from being realized.

In conclusion, I would say that the field of ES cell research is in a fragile state at best under the current presidential policy. The current policy represents a halfhearted effort to support this revolution in biology and threatens to starve the field at a time when greater nourishment is critical.

It's a testimonial to the passion of the young scientists that come to my lab, who are so driven by the enormous potential of ES cells , that they are willing to work diligently, despite the uncertainties intrinsic to the current policy. It's the spirit of scientific passion and enthusiasm, combined with a truly generous financial commitment to healthcare research by our federal government, that has made American science and our healthcare system the envy of the world. As a nation, we should not miss the opportunity to nurture and invigorate this exciting field of medical research.

Thank you.

SPECTER: Thank you very much, Dr. Daley.

Dr. Zerhouni, we start with you on the questioning. You heard the testimony about the sharp limitations on the availability of stem cell research lines.

In the fall of last year, when NIH assembled the stem cell registry, you listed 78 stem cells lines from 14 sources around the world. According to the information which our subcommittee has been able to glean, only five of these lines are available to stem cell researchers.

NIH has awarded, as you testified, $4.3 million in infrastructure grants to five companies and institutions with 23 eligible stem cell lines. Of these five companies, we are told only four have signed material transfer agreements with NIH. And these four companies have only 17 eligible stem cell lines. Of these 17 stem cell lines, only five have been shipped and are available to researchers.

Would you start the clock? We're going to have five-minute rounds?

The question is: is there a sufficient number of stem cell lines available for the required research?

ZERHOUNI: Well, in terms of the number of eligible lines, which is as you said 78, and the number of lines available for wide distribution, we would agree that over the year, there has been an increasing number of lines. Last spring, there was one; this month, there's five. As far as we can tell from talking to all of the suppliers, there are 10.

I went over, in my opening statement, about the timeline that it takes to go from an eligible line that is just derived to a widely available, distributable line.

So I think that progress is being made. And we are, as diligently as possible, working -- as mentioned by some of the researchers -- diligently working with as many sources as we can to make more lines available.

SPECTER: You're working with the sources of the 78 lines, which were approved by the president as of August 9.

ZERHOUNI: Correct.

SPECTER: And the question is: is that adequate?

ZERHOUNI: Right.

SPECTER: I know you're bound by the administration's decision. But the Congress has the authority to legislate in the field. The president may veto it. We can override a veto by two-thirds.

In the spring of 2000, when the NIH funding was not available on all the stem cell research, Senator Harkin and I and others started to move. And we had letters signed by 64 senators disagreeing with the federal policy on stem cells .

And I had personal commitments from 12 more who were unwilling to put it in writing, but assured me that they would support legislation in the field. And then the president came out with his compromise position, in essence, on August 9. And immediately after that, there was a flurry of publicity as to whether those lines were adequate. And the indications were at that time that they were not.

After September 11, all of the oxygen has been sucked out of Washington on virtually every other subject until Iraq came along to take some precedence. And we have been waiting to see the developments and have deferred this hearing.

But now, we're going to be faced with the decision as to what to do next. So it's a pretty blunt question as to whether the existing stem cell lines are available or adequate.

And you have heard your colleagues at the table. What do you think?

ZERHOUNI: My feeling is that we are at the very early stage. It is actually not knowable how many lines you will need to advance the field. In other comparable fields, very often researchers want to limit the number of well characterized lines that are used for experimentation.

So I would say that, at this moment, I don't think we know the answer. We need to work and develop more researchers and more laboratories that are going to experiment with the lines that we want to make available to find that answer.

I really do not know the answer.

SPECTER: Well, Dr. Zerhouni, when will we know? Can you give me a timeline as to when we'll know?

ZERHOUNI: We'll work as diligently as we can to make as many lines available to as many laboratories. There is no limit to the funding that we can direct to the laboratories that present good, solid research proposals.

SPECTER: Dr. Pedersen, to what extent do you think your example will be followed by others in leaving the United States to go to places like Great Britain where you can find funding on stem cell research?

PEDERSEN: I can't answer that exactly, senator. But we're working diligently as possible to recruit them.

(LAUGHTER)

SPECTER: Have you had any success?

PEDERSEN: How I would like to answer that is in part a response to your prior question, which is how many cell lines are available to do the necessary work? And how many are needed?

There are, I think, adequate numbers of existing cell lines to do a portion of the work, the portion that will be focused on in the United States with federal funding -- namely, the characterization of the steps needed to get useful specialized cells . So the dozen or so that are currently available -- actually available -- probably are sufficient to do that.

I think this number issue is a red herring, though, because to go into patient care, the existing lines are not really useful because they've all been grown with a combination of mouse cells , which makes them unsuitable for transplantation. So the actual number of suitable lines for transplantation is zero in the current set. And new lines must be generated.

So the clinical delivery very likely will take place elsewhere. And people who are interested in participating in that part of it will probably have to do so elsewhere.

SPECTER: So you're saying the number of stem cell lines for clinical delivery transplantation is zero.

PEDERSEN: On the registry is zero. There is one line that was developed recently in Singapore.

SPECTER: Well, that could hardly be characterized as an adequate number.

PEDERSEN: And so, the development of such lines in the U.S. would require a change in policy.

SPECTER: My red line is on, plus 39 seconds for your last answer.

Senator Hutchison?

HUTCHISON: Well, thank you, Mr. Chairman, for holding this hearing. And thank all of you for coming.

I am very concerned about the real life stories. You know, I always am interested when policies are set. And I think the president's policy was meant to be one that would allow for real use of the lines that are available so that we could do the testing that is necessary.

But then I hear your stories about trying to get lines and then India doesn't let them out. And then you try to get a line in another way from Wisconsin. And yes, it's coming; well, no it isn't; well, yes, it is later.

And that doesn't seem to be working in the practical sense. And I have researchers at UT-Southwestern who are very concerned about availability.

They are now doing work with animal nerve and pancreatic stem cells . They want to further that study. And they're very concerned about access.

So I would just ask you this question. I think that Senator Specter asked the big question: what can we do to make it more practically available? I think all of us are concerned about that.

On top of that, though, I now have another concern. And that is, I have some great research institutions -- M.D. Anderson, Baylor, UT- Southwestern, UT-San Antonio, UT-Galveston. They are really in the cutting edge of research.

Now California has stepped forward, I think, in a way that could start luring some of our good scientists to California. And I would like to ask you this question, Dr. Zerhouni.

Now that California is looking at giving state help in this regard -- and so many of our institutions are public institutions that do get private help, but also need government help -- what can we do to keep everything balanced? So that, all of a sudden, we don't see people migrating from Harvard and Johns Hopkins and all these other great research institutions, including mine, all to the West Coast?

And I'm not saying I don't wish the West Coast well. I do. But I don't want to, all of a sudden, throw a big kink in the research world. So tell me how we can deal with that effectively.

ZERHOUNI: Well clearly, I think, in terms of federal funding, we need to look at all the aspects of facilitation of the research. And that's what we're doing.

We've established a Stem Cell Task Force so we can get input from the scientific community from all states as to exactly how we can, in fact, enhance the ability of these institutions to do the research. As Dr. Pedersen said, we need to do the basic research before we can go. It will take years. But we need to do that.

In terms of state support and private support, there is nothing in the current regulation that prevents that from happening. In California, for example, the UC-SF lines were developed in part with state help.

HUTCHISON: I understand that, Dr. Zerhouni. I know it's possible.

But the amount that is available from private and state funds is not comparable to what could be available from federal funds. And so you are now looking at a potential problem, I think, even though private funds can be used. But it does become complicated, especially if you're doing a project that has federal funds and then you want to take the next step. You want to go to the stem cell part that would actually show results. Do you have to stop doing the federally funded research? I mean . . .

ZERHOUNI: Currently, we allow researchers to do side-by-side federally funded researchers or not federally funded researchers in parallel. There is no NIH policy that prevents that.

So I think that can still be done.

HUTCHISON: And it can be the same exact project? So you're on a project and the next thing you want to do is test it with embryonic stem cells . And you have a federally funded project.

Can you use embryonic stem cells , under the present law or the president's policy, to do that research?

ZERHOUNI: As long as there is strict accounting of what is used. The present policy is very clear. You can not use federal funds for non-eligible lines. And you have to have in place accounting mechanisms, which are clearly spelled out in our policies, to be able to do that. But it is doable.

HUTCHISON: Well, I would like to ask other members of the panel if they feel that that differentiation is enough to allow people to go forward.

CIVIN: Senator Hutchison, I was thinking of a slightly different analogy in terms of California when I read this in the news. And I was hoping that Maryland would do the same thing and that other states would follow Justice Brandeis' suggestion, I believe, that the states should be the laboratories of democracy in this area of stem cell research and that we should experiment with different solutions.

I happen to think that the solution of the state of California is outstanding and would like to see that be the example for our federal solution that is followed by the entire government. Because this is where the money that will make the rubber hit the road will happen. Very little funding realistically will come from the states for very much research. It has to be federal funding for it to work.

Ultimately, it has to be a coherent federal policy so that we can collaborate across the country on our research. But I see instead California as an example of a laboratory for democracy here.

HUTCHISON: Dr. Schatten?

SCHATTEN: Yeah, Senator Hutchison, thank you so much for these probing questions. And I think we need to acknowledge that Dr. Zerhouni and the entire NIH is doing absolutely everything within their powers. But it is not within their power.

I know from my own experiences that in order for us to work on eggs that have failed to be fertilized from an IVF clinic, we need absolutely everything to be privately funded, even million dollar microscopes that we might use for just 10 minutes. And many university administrators that their full federal funding could be withdrawn if one investigator enters into an area that might pose a risk because of a confusion in how funds are either mingled or not co- mingled.

And I think really it is at this level, as Senator Specter has mentioned, that we could benefit from a clear, national policy.

Thank you.

HUTCHISON: Thank you. I have seen the difference that the doubling of the NIH -- is the red light on? Am I taking your time? I'll finish.

I have seen the difference that the doubling of the NIH budget has made in the area of research, particularly into diseases that are not prolific diseases, but nevertheless, need to have research into them. And I know that the availability of federal funding is making a huge difference in the knowledge base that we have and medical research into so many diseases that have been ignored in the past.

So I would just say that I think Dr. Schatten's point is very good. I think NIH is doing everything they can. I think they are moving forward in every possible way with the policies that we have.

But I just want to see what more we can do and also determine if something works in practicality after it is set forward. And I even think the president meant to do that. I think he said, "This is going to be -- we're going to try this. This is the best way to approach it, in a very careful way."

And he wanted to be careful because he values life so much. So I know his intentions were right. But I also think he left it open for us to come back and say -- not me, but you, the research community and you, Dr. Zerhouni. He is going to look to you for advice, to say, "Did it work? How can we continue progress in a way that also gives value to human life?"

I think we just have to keep working on input from the research community and creativity, which I think Senator Specter is showing in trying to create a fund -- not a fund, but a bank -- at NIH, perhaps with some of these lines to make sure that they don't get into legalistic delays and bureaucratic stumbling that stop progress in America. I want this research to be done in America. And I want you to come home.

SPECTER: Thank you very much, Dr. Hutchison. We are now about nine minutes into a fifteen-minute vote, so we're going to have to adjourn, as I had mentioned earlier.

What I would like you to do, Dr. Schatten, Dr. Civin, Dr. Daley, Senator Ortiz and Dr. Pedersen, is to provide in writing what you would like to have available. You talked about, Dr. Daley, nuclear transfer studies. I'd like to get the specifics as to what you have in mind.

Dr. Civin commented about waiting a year for lines and has not gotten them yet. Dr. Schatten talked about not enough lines available and worried about therapeutic cloning, as Senator Ortiz said.

I believe that the legislation passed by the House imposing criminal penalties on nuclear transplantation or so-called therapeutic cloning will not come to pass. We have stopped it in the Senate. And we may have 60 votes, if there was time on the calendar, to pass a bill which would permit nuclear transplantation.

And I think Senator Hutchison summarized the matter well. The president took a step -- a significant step -- on August 9th in permitting some federal funding. He was subjected to a lot of criticism.

It's pretty hard not to be criticized on virtually whatever the president or any of us in elective office do. So we're used to that.

But then we have to see what has happened. And I would like you to respond specifically to what you'd like to see done.

And Senator Ortiz, you have special insights into legislation. Give me your insights as to what legislation you would like to see done.

My own sense, at the moment, is that the Congress is going to have to legislate on the subject. And we had waited for a year-plus to see the experience.

And Dr. Zerhouni, if you can supplement what you have said with a timeline as to when you think you might know, we will be interested to know that. But I think the time has come to legislate in the field.

And as I said, last year, we had 64 senators in writing and commitments from 12 more. And 12 and 64 is 76, which is nine more than 67. So we are in a position to move where the need is sufficiently great. And I think this testimony has been very, very helpful.

And I think we've gotten the kernel of it. And your written answers will give us the balance.

So thank you all very much for coming in. That concludes our hearing.