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before the

Committee on Health, Education, Labor and Pensions

United States Senate

September 5, 2001

Mr. Chairman, Senator Gregg, and Members of the Committee, I am pleased to appear before you today to testify about the President=s decision to permit federal funding for research using human embryonic stem cell lines. I am accompanied by Lana Skirboll, Director of the Office of Science Policy at the NIH, Mark Rohrbaugh, Deputy Director of the Office of Technology Transfer at the NIH, and Kathy Zoon, Director of the Center for Biologics Evaluation and Research at the FDA.

I am pleased to be here today because I believe that President Bush has made a wise decision, one that we can only guess at the import right now. This was not an easy decision, and as his words to the Nation made crystal clear, it was not a decision that was made lightly. President Bush is guided by a strong set of principles, and he, like all of us, strongly values human life. Importantly, no federal funds will be used to support the destruction or creation of new embryos, and federal funds will not be used to support research on stem cell lines that are derived from newly destroyed embryos. The principle that the federal government should not encourage or sanction the destruction of embryos was a cornerstone of the President=s decision.

This President, by exhibiting such strong leadership, has helped to create a research environment that we all hope will lead to cures for such diseases as diabetes, Parkinson=s disease, spinal cord injury, stroke, Lou Gehrig=s disease, and Alzheimer=s disease - just to name a few. President Bush has given hope to us all; the scientific community, those suffering from these devastating illnesses, and anyone who has ever seen a loved one suffer from a debilitating disease.

Very early on in my tenure at the Department, I asked NIH to prepare a report on what was known about human embryonic stem cells: in short, to do a review of the science. What investigators found, and what the scientific community has been saying, is that today very little is known. The first human embryonic stem cell was isolated only a little over three years ago. Very few people in the world are working with this type of cell. Yet, in that short time, and combined with research that has been done on animal embryonic stem cells, we all have every right to feel hopeful about what scientists may be able to accomplish.

Human embryonic stem cells are unique. They are capable of continuous self-renewal and of the ability to give rise to all cell types that comprise the human body. But at this point, we know almost nothing about their potential to treat disease. And we don=t know how they compare to adult stem cells.

On August 9, 2001, the President announced that federal funds may be awarded for research involving the use of human embryonic stem cell lines that meet the following criteria:

  • The derivation process was initiated prior to 9:00 p.m. EDT on August 9, 2001;
  • The stem cells were derived from an embryo that was created for reproductive purposes and was no longer needed for such purposes; and
  • An informed consent was obtained for the donation of the embryo, and that donation did not involve financial inducements.

When NIH first presented its report on the state of the science to me in June, it had documented at least 30 lines. In follow-up discussions, it was clear that NIH had heard about the possibility of others, even though scientists had not yet published their findings regarding some of these other lines, and many were in the early stages of development. So I asked NIH to go back, talk to these scientists and companies, and find out everything it could about the stem cell lines that currently exist. What investigators at NIH found was that more stem cell lines existed, in various stages of development, than anybody had realized.

Some were identified from publications and presentations at scientific meetings. Others were identified in the course of preparing the NIH report on stem cells through general discussions with the scientists who had worked in the field. In some cases, the organizations called NIH, and in others, information was provided to NIH during inquiries regarding compliance with the former NIH Guidelines.

To date, investigators from ten laboratories in the United States, Australia, India, Israel, and Sweden have reported to the NIH that they have derived stem cells from 64 individual, genetically diverse early embryos. These human embryonic stem cell lines are currently viable, exhibit characteristic stem cell morphology, and have undergone at least several population doublings. The majority of these cell lines are reported to express all of the markers known to be associated with human embryonic stem cells.

All 64 of these human embryonic stem cell lines, which are in various stages of development, meet the President=s criteria and are therefore qualified for use in federally funded human embryonic stem cell research. The NIH has met or spoken extensively with each of the investigators responsible for the derivation of these cells. These scientists have expressed interest in working with the NIH and the research community to establish a research infrastructure that ensures the successful handling and use of these embryonic stem cells in the laboratory. How researchers will be able to use these stem cell lines, some of which are in the earliest stages of development, for laboratory research is a valid and important research question, and I encourage scientists to begin looking for an answer as soon as possible. Likewise, the question of how to determine the quality or usefulness of any cell line is an open question that also requires research, and we encourage investigators to apply for NIH grants to answer it.

By allowing, for the first time, the use of federal funds for research on human embryonic stem cells, the President has opened the door to a promising field of scientific opportunity for some of the best and the brightest investigators who conduct their work with the financial support of the federal government.

I am working with NIH to ensure that the scientific community will be able to use federal funds to tap the extraordinary research potential of human embryonic stem cells. We are hoping to begin funding this research using a variety of mechanisms: grants, contracts, cooperative agreements, and supplements to existing grants. Today, our goal is to ensure that cells are available and ready for distribution and to help and encourage researchers who are working with these human embryonic stem lines, which are in various stages of development, to conduct the additional research that will make these lines available for research use. There are challenges ahead.

First, in order to facilitate the much-needed basic research using human embryonic stem cells, the NIH is creating a Human Embryonic Stem Cell Registry that will list the human embryonic stem cells that meet the eligibility criteria and provide basic information about the cells.

And there is more to do. We need to encourage the further characterization of those lines that are in the earliest stages of development. We need to provide technical assistance and funds for the large-scale expansion of stem cell lines so that they are available to as many researchers as wish to use them. We need to minimize the administrative burden, with regard to requests for the distribution of cells, both for scientists who have derived these cells and researchers who wish to use them. And because these cells are challenging to work with, we need to determine in what manner we will provide training to researchers on how to maintain, grow and handle these cells in their own labs. NIH may hold workshops and conferences to encourage broad scientific dialogue about research ideas, and the identification and resolution of technical problems inherent to any new arena of research. Finally, and most importantly, NIH needs to do what it does best: fund the most promising ideas, gain new knowledge from research, and use that knowledge to improve human health.

As with other types of research, recipients of NIH funding will be responsible for arranging access to particular cells that they determine are necessary for their research. The NIH is interested both in accessing cells for use in its intramural research program, as well as in facilitating access for the broader research community. The goal is to encourage the transfer of cells from qualified providers under acceptable conditions and with as minimal an administrative burden as possible.

Recently, the NIH has met with investigators who have derived these cells to discuss these topics. At these meetings, the NIH has, on behalf of its intramural investigators, initiated negotiations with organizations that have derived human embryonic stem cells. Although the NIH does not have the authority to negotiate agreements on behalf of grantee institutions or third parties, it has been the NIH=s experience in other cases that the agreement into which it enters may serve as a model for subsequent agreements negotiated by NIH-funded investigators, should their institutions choose to adopt it.

Some scientists have asked about the effect that patents filed or issued over the past few years will have on human embryonic stem cell research. The issuance of patents on new discoveries need not adversely affect continuing research, provided that the patent owners devise a licensing and sharing strategy to allow basic research to proceed. Experience has shown that conditions imposed by patent owners can be crafted both to ensure research uses and to provide appropriate incentives for commercial development. Although the specific terms and conditions of availability must be determined between providers of the cells and the recipients, we are pleased by the willingness of the researchers who have derived cells to make them available for use by federally funded researchers.

Although scientists will soon have the opportunity to explore the promise of human embryonic stem cells, I wish to make it very clear that this research must proceed responsibly and ethically. We have much to learn about these cells - much basic research that needs to be conducted. Clinical applications, which could possibly emerge only after considerable basic research, are years away. What is important now is that we begin the process of gaining a thorough and scientifically based understanding of the promise and potential of embryonic stem cell research.

The NIH is now implementing the President=s policy. It is our hope that federally funded investigators will take full advantage of this new opportunity to conduct research on existing human embryonic stem cells and explore the enormous promise of these unique cells, including their potential to produce breakthrough therapies and cures. At the same time, NIH will continue vigorously to support research on animal stem cells and human adult stem cells, including those found in umbilical cord blood, so that in the not too distant future we will be in position to understand the relative benefits and limitations of all types of stem cells. With the help of the scientific community, this research will mark the beginning of a new era in modern medicine.

Mr. Chairman, it is time for federally funded scientists to begin the fundamental research that is needed to determine the true potential of stem cells. We will provide scientists with ample opportunities to fully investigate this potential. We urge the research community to begin these explorations with the profound hope that we stand at the threshold of a true breakthrough in our ability to treat disease and disability.

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Last revised: October 1, 2001