107th Congress

Stem Cells #8: Stem Cells, Scientific Progress and Future Research Directions -- Hearing Before the Senate Appropriations -- Subcommittee on Labor, HHS, Education -- July 18, 2001

Members Present

Senator Tom Harkin (D-IA), Chairman; Arlen Specter (R-PA), Ranking Minority Member; Senators Herb Kohl (D-WI); Patty Murray (D-WA); Mary Landrieu (D-LA); Thad Cochran (R-MS); Michael DeWine (R-OH) and Kay Bailey Hutchison (R-TX).

Witnesses:

Panel 1: Senators Orrin Hatch (R-UT), GORDon Smith (R-OR), Sam Brownback (R-KS), and William Frist (R-TN).

Panel 2: Lana Skirboll, Ph.D., Associate Director for Science Policy, National Institutes of Health; Diane Krause, M.D., Ph.D., Associate Professor, Yale University; Mary Hendrix, Ph.D., Professor and Head, Department of Anatomy and Cell Biology, University of Iowa; Michael West, Ph.D., President and Chief Executive Officer, Advanced Cell Technology; William Gibbons, M.D., Chairman, Jones Institute for Reproductive Medicine; and Richard M. Doerflinger, Associate Director for Policy Development, Secretariat for Pro-Life Activities, National Conference of Catholic Bishops.

Summary:

Purpose of Hearing: This hearing, the eighth stem cell hearing held by this Subcommittee, was to provide a forum for release of the NIH report "Stem Cells, Scientific Progress and Future Research Directions," which reviews the current state of the science of stem cell research. However, it was also an opportunity to hear from conservative Members of the Senate who had recently spoken out in favor of Federal funding for human embryonic stem cell research. Other Members of the Subcommittee who expressed support for Federal funding for human embryonic stem cell research included Senators Specter and Murray, who is a co-sponsor of the Specter-Harkin legislation. Senator Cochran said, "This issue deserves our best efforts to learn the facts and act on them to serve the public interest." Senators DeWine and Hutchison did not offer an opinion.

Opening Statements:

Senator Harkin mentioned the pending bill sponsored by Senators Harkin and Specter that would allow federally funded scientists to derive human stem cells from embryos under four conditions. Specifics of the measure include that embryos must be obtained from an in vitro fertilization clinic, the donors must have provided informed consent, the embryo must no longer be needed for infertility treatments, and there can be no payment to the donors. He also stated that while some say that stem cell research is fine as long as you use just adult cells, he disagreed. Pointing to the NIH report, he said, "Embryonic and adult stem cells are different, and both present immense research opportunities for other potential therapies. I think it would be irresponsible to wait for years to determine the potential of adult stem cells before studying the benefits of embryonic stem cells."

Senator Specter echoed the remarks of Senator Harkin, noting that he believes there are sufficient votes in the Senate to pass their bill. He also raised an issue of concern to him about the difficulty of this Subcommittee in getting the "unvarnished facts from the Department of Health and Human Services." He reiterated his concerns about the responses from NIH to the stem cell questions posed in May. He noted that of the 15 letters which were submitted, there were 21 deletions in 10 of the letters, and then proceeded to read some examples for illustration. He then moved on to the stem cell report. He noted that he read about the report in the New York Times on June 27. He immediately, thereafter, started to request it, but couldn't get a copy of the report. He wrote to the Secretary of HHS on July 11, 2001, and again on July 17. He further stated that Secretary Thompson's reply of July 31, 2001, did not respond to the censorship issue. He, subsequently, asked to have a copy of the original report, as submitted to DHHS, submitted to him.

Senator Murray spoke in support of stem cell research and noted that she is a cosponsor of the Specter-Harkin legislation. She said that her father had suffered from multiple sclerosis and expressed her hope that this research might address diseases such as this.

Statements of Witnesses:

Panel 1: The first panel, comprised of U.S. Senators, was the focal point of the hearing. The majority of the time of the hearing was spent in discussions with these Members. Senators Smith and Hatch are two Members who consider themselves to hold strong pro-life, profamily values and strongly oppose abortion but who, after much reflection and thought, have spoken out in favor of this research. They have sent letters of support for this research to both the Secretary of HHS and the President, urging support. Perhaps the most moving testimony was offered by Senator Smith, who spoke of watching his cousin Congressman Morris Udall, "literally die in public of Parkinson's disease." He then addressed the issue of where he believes life begins, which is a major issue for individuals of faith relative to the stem cell debate. "I believe that life begins in the mother's womb, not in the scientist's laboratory.... And I believe the Federal Government should play a role in research to assure transparency, to assure morality, to assure humanity, and to provide the ethical limits and moral boundaries which are important to this issue. Those boundaries and limits must stop at a mother's womb. For again, that is where life begins."

Senator Frist, who had not taken a public position on this issue until the evening before the hearing and also holds strong pro-life values, concluded "that both embryonic stem cell research, as well as the adult stem cell research, should be federally funded within a very carefully regulated, fully transparent framework that ensures the highest respect for the moral significance of the human embryo." He then articulated what he called a "comprehensive framework" under which he said he believes such research should be carried out. The ten points he outlined were the following: 1) ban creation of embryos solely for research purposes, 2) continue the funding ban on the derivation of stem cells from human embryos, 3) ban human cloning, 4) increase adult stem cell research funding, 5) provide funding for embryonic stem cell research only from blastocysts that would otherwise be discarded (using only those blastocysts that are left over after in vitro fertilization and would otherwise be discarded), 6) require a rigorous informed consent process, 7) limit the number of stem cell lines, 8) establish a strong public research oversight system--a national research registry to ensure the transparent in-depth monitoring of federally funded and federally regulated stem cell research, and to promote the ethical, high-quality research standards, 9) require ongoing independent scientific and ethical review, an ongoing scientific review by the Institute of Medicine--an independent presidential advisory panel--to monitor the evolving bioethical issues surrounding stem cell research with annual reports to Congress, and 10) strengthen and harmonize the fetal tissue research restrictions.

These points generated much of the subsequent discussion, both with this panel and the next, particularly the issue of deriving additional stem cell lines and whether that should be federally funded, and the issue of how many separate stem cell lines are appropriate for research to proceed. There was not unanimity among the panel members about whether Federal funds should be used to derive the stem cells--Senators Hatch, Frist and Brownback opposed the use of Federal funds for derivation, but Senator Smith disagreed and said that if one believes the research to be appropriate, then the process of getting to that point must also be appropriate. Senator Brownback stated that he does not support any research where human embryos must be destroyed to derive stem cells. The panel members were asked whether they opposed in vitro fertilization? Each of the panel members said that he was not opposed to this. Senator Specter raised two issues which were discussed with the first panel and carried on with the second panel. One was the issue of how many cell lines would be adequate for research, and the other was that the Federal government should derive the stem cells and cell lines. Although he stated at the outset that he would oppose the creation of additional cell lines, after further discussion, Senator Frist said, "I would propose that we have a discussion with the scientists and say how many do you really need." This was reinforced by a witness from the second panel, Dr. Krause, who, in her testimony, raised this issue that the proposals to limit funding research to only existing cell lines is far too limiting; that scientists need to compare multiple cell lines in order to better understand the common factors that gave embryonic stem cells their incredible plasticity. When Senator Specter raised the second issue of NIH deriving stem cells and cell lines, Dr. Skirboll said that there may well be intellectual property issues with regard to patenting and the patenting of the technology that may or may not allow for Federal funds to go toward derivation.

Panel 2: Dr. Skirboll presented the NIH report "Stem Cells, Scientific Progress and Future Research Directions," which is based on a review of more than 1200 scientific articles and interviews with over 50 private and public sector scientists conducting stem cell research, and addresses both animal and human stem cell biology. It reviews research on adult stem cells as well as stem cells derived from embryos and fetal tissue. Dr. Skirboll pointed out what is needed to pursue this research: scientists need cultured cell lines that are pure, cell lines that are well characterized and identical for safety reasons; they need cell lines that are diverse, that have the capacity to develop into as many kinds of cells that are possible to replace tissues that are destroyed or damaged from disease; and cells that proliferate, can make sufficient quantities in culture so that many patients will have access to them. The report also addressed the ability of these cells to differentiate into specialized cells and ultimately to function, and made three determinations: 1) both adult and embryonic stem cell types may be useful in developing cell based therapies, 2) these kinds of stem cells are different, and 3) there are more unanswered questions than there are answers. "Scientists all agree that stem cell research holds enormous promise to lengthen and improve the quality of life for many patients suffering from perhaps a broad spectrum of diseases--spinal cORD injuries, Parkinson's disease, heart disease, kidney disease, liver failure, multiple sclerosis, Alzheimer's disease and diabetes to name a few. In summary, because it is not known from which stem cell type the best therapies will come for these diseases, scientists believe the door should be left open to conduct research on both embryonic and adult stem cells."

Both Mr. Dorflinger and Dr. Anton-Lewis Usala spoke in opposition to embryonic stem cell research under any circumstances. Mr. Dorflinger called it illegal, immoral and unnecessary; and Dr. Usala called it "a cataclysmic paradigm shift. The perceived right of the state will have superseded the right of the individual."

Dr. Susan Lanzendorf, the lead scientist on the recently published work concerning the experience of the Jones Institute with human stem cells, described the rationale and work of the Jones Institute which uses donated gametes to produce embryonic stem cells. She urged that resources be made available to continue the research endeavors of the scientific community in the area of human embryonic stem cells. Michael West spoke in favor of therapeutic cloning, as a means by which the problem of transplantation histocompatibility could be addressed.

Dr. Diane Krause, an associate professor at Yale University School of Medicine and a researcher on adult-derived stem cells, testified about why Federal funds need to be applied to embryonic stem cell research. She stated that it is important that the Subcommittee understand that adult stem cell research is not a substitute for embryonic stem cell research. She said she was deeply concerned that people seeking to end Federal funding for human embryonic stem cell research were using her data as justification for no Federal funding. She said this "interpretation is not only stunningly premature but potentially undermines the development of adult stem cell therapeutic options." Dr. Mary Hendrix spoke as a scientist conducting cancer research and as the past president of FASEB. She said that FASEB strongly supports allowing human embryonic stem cell research and, based on current knowledge, while adult stem cell research is highly promising and should be pursued, embryonic stem cells have greater potential.

Questions

Specter:

Took issue with Senator Frist on two of his points--continuance of the Federal funding ban on derivation and limiting the number of stem cells lines, but conceded that he is prepared to, as Senator Frist seemed to be, to rely upon the scientists to tell us how many cell lines are needed.

To Senator Frist: If we are going to have the Federal Government pay their private concerns to derive embryos, it seems to me much wiser to have NIH do it directly.

To Dr. Skirboll: Do we need more stem cell lines? Are there adequate stem cells available at the present time for NIH to do research without having derivation paid for by the Federal Government? Isn't it true that you will need to have Federal funding to get adequate number of stem cells from the embryos if this research is to continue? Is there any conceivable excuse for NIH not to actively seek to have the federal funding available to extract them from embryos? The concern I have is that your report is a quasi political document because it does not tackle the question of Federal funding to extract stem cells from embryos. I am not asking you for a political position, I'm asking you a scientific question.

When was this report substantially completed, Dr. Skirboll? How many changes were made except for editorial comments and punctuation and a little polishing after June 19 when you submitted the report? Was it substantially completed in draft form? We would like to have a copy of that draft report to compare it to what was finally completed.

Harkin:

To Senator Frist: I wonder about the logic that would allow our Federal researchers to work on stem cells but not to derive them.

To Senator Frist: What incentive will the private sector have to derive the stem cells if all they're going to do is give them free to NIH? Or is NIH going to have to purchase these? Is that acceptable?

To the Panel: Are you opposed to in vitro fertilization?

To Senator Frist: Would you only support use of in vitro fertilization embryos no longer needed only if they have been frozen?

To Dr. Skirboll: Does it make any sense to allow federally funded researchers to work with embryonic stem cells already derived, but not to allow those researchers to derive the stem cells in their own labs?

To Dr. Hendrix: If you decided to do research today using embryonic stem cells, but you were limited to using those lines now in existence, what problems would that present for you? Are there sufficient existing stem cell lines; do they offer sufficient diversity; are there patent issues? And we heard the discussion--you heard the discussion this morning, is it 30, is it 50, is it 100, is it 200? Do we have any idea at all how many lines that we think might be sufficient? How do we finally figure this out?

To Dr. West: Would you tell me again how your research differs from what we're talking about in terms of embryonic stem cell research? What is the procedure?

Hutchison:

To Senator Frist: It's my understanding that the longer an embryo from in vitro fertilization is frozen, the less likely it is to be as viable. If it's not viable as a potential life, is it still viable for stem cell research?

To Mr. Dorflinger: It seems to me that when you talk about adult stem cells being adequate, which is the argument being made by some, isn't the availability always going to be in question because of the pain involved in extracting stem cells for someone to donate just to an unknown?

To the Other Members of the Second Panel: Are adult stem cells as effective as the stem cells from embryos about which we are speaking today? Do you think there is a lack of availability of adult stem cells because of the pain involved at this point in donating? Is there a possibility that the cORD blood could be as effective as the embryonic stem cells? Do you think we should pursue it?

DeWine:

To the Second Panel: I wonder if I can ask the panel if you could give us some idea of how much private funding is currently going into human embryonic research?

I would assume that the amount of money spent on this is going to continue to grow very significantly. Does anyone disagree with that?

Prepared by Anne Houser/OD/OLPA, August 7, 2001