107th Congress

“Progress in Making Stem Cells Available to Federally-Funded Researchers” -- Hearing Before the Senate Appropriations Subcommittee on Labor, Health and Human Services, Education -- October 31, 2001

Members Present

Senator Arlen Specter (R-PA), Ranking Minority Member

Witnesses

Panel 1: Wendy Baldwin, Deputy Director for Extramural Research, National Institutes of Health (NIH)

Panel 2: Bert Vogelstein, Chairman, Institute of Medicine, Johns Hopkins University

Panel 3: Martin Pera, Monash University, Australia; Joseph Itskovitz, Rambam Medical Center, Technion University, Haifa, Israel; James Thomson, CSO, WiCell Research Institute, Inc.; Carl Gulbrandsen, President, WiCell Research Institute, Inc.

Introduction:

This was the tenth stem cell hearing held by the Senate Appropriations Subcommittee on Labor, Health and Human Services (HHS), Education (Senator Tom Harkin [D-IA], Chairman) to examine “the progress in making stem cells available to Federally-funded researchers.” Senator Specter chaired the hearing and was the only Member in attendance. He stated at the outset that the fiscal year (FY) 2002 Labor, HHS, Education Appropriations Bill would be on the Senate floor for debate beginning in one hour; and the hearing, therefore, would be limited to an hour and 15 minutes.

Summary

Purpose of the Hearing: On August 9, 2001, President Bush announced that Federal funds may be awarded for research using human embryonic stem cell lines that meet certain criteria. Such research is now eligible for Federal funding as long as the derivation process (which begins with the destruction of the embryo) was initiated prior to 9:00 p.m. EDT on August 9, 2001. These stem cells must have been derived from an embryo that was created for reproductive purposes and was no longer needed for such purposes. In addition, informed consent must have been obtained for the donation of the embryo, and that donation must not have involved financial inducements. The hearing was held to hear testimony from scientists who have derived the stem cells that will be made available for Federally-funded research. Senator Specter focused on the status of characterization of the lines, whether the lines are viable and meet the President's criteria, and whether these lines derived by August 9 would meet the needs of scientists to treat patients or whether more stem cell lines will be needed. He also asked the witnesses about the scientific impact of an amendment to the Labor, HHS, Education Appropriations Bill that was expected to be offered by Senator Sam Brownback (R-KS) that would prohibit “therapeutic cloning.” He also asked about another possible amendment from Senator Brownback that would prohibit the mixing of human and animal gametes. He acknowledged that he was going to incorporate information from the witnesses into his floor statements for debate on these amendments.

NIH Statement: Dr. Baldwin discussed NIH actions to lay the groundwork so that Federally-funded research could begin. She discussed the issue of licensing agreements with the holder of the U.S. patent of human embryonic stem cell technologies, and that NIH has also met with the investigators from all over the world who are responsible for development of the existing stem cell lines eligible for Federal funding. Lastly, she discussed the NIH process of establishing a web-based Human Embryonic Stem Cell Registry to list all of the cells that meet the eligibility criteria and are currently available for research, to enable investigators to discuss obtaining cells for their research, and to refer to one of the eligible sources in their funding application.

• Stem Cell Registry: Dr. Baldwin was asked about the stem cell lines, the nature of the assurances (particularly the lines from India and Sweden), whether they meet the President's guidelines, and whether the lines are actually available for use by investigators. She was not asked about the status of the stem cell registry until Dr. Thomson expressed concern to the Chairman that the registry was not yet available, and asked for the Chairman's help to expedite its availability. Senator Specter pressed Dr. Baldwin to set a date, finally asking if it could be done “within a week.” Dr. Baldwin replied, “I think that is a reasonable expectation.”


• Indirect Costs: In response to another issue raised by Dr. Thomson, Dr. Baldwin was asked about the issue of indirect costs paid to institutions which may restrict the ability of academic health centers to use new human ES lines derived by the private sector in clinical trials if the President's policy remains in place. Senator Specter asked Dr. Thomson how soon the issue would become truly problematic. He was told that it would become concerning in about 2 to 3 years from now, when clinical work may begin.


• Adequacy of Stem Cell Lines: Witnesses from Panel 2 were asked their views on the adequacy of the current stem cell lines. Witnesses generally agreed that the current lines were adequate to conduct basic research but diverged about whether the lines would be usable for clinical research, either because of “xenotransplantation” concerns or sufficiency of diversity of the lines. Dr. Gulbrandsen also was questioned about the terms of his MOU which precludes diagnostic or therapeutic use of the Wisconsin materials without negotiation of a commercial license and the impact of that restriction on future clinical therapy. The panel was also pressed about the impact of a prohibition on therapeutic cloning for future research and clinical application of the basic stem cell research. The witnesses were not in agreement on the severity of the impact, though all agreed it would be optimal not to limit this field of research.

Followup:

Subsequent to the hearing, the Senate took up the proposed Brownback amendments to H.R. 3061, the FY 2002 Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, regarding cloning, human embryo research, and the creation of animal/human hybrids. Senators Specter and Brownback agreed to a compromise. Senator Specter agreed to withdraw the stem cell language in the bill. The Senate bill would continue the provision to prohibit the use of funds in the act concerning research involving human embryos but would have added a new section (sponsored by Senator Specter) to it as follows: “(c) Subject to the provisions in section 510 (a) and (b), Federal dollars are permitted, at the discretion of the President, solely for the purpose of stem cell research, on embryos that have been created in excess of clinical need and will be discarded, and donated with the written consent of the progenitors.” It is this latter language which was deleted from the bill as part of the agreement with Senator Brownback. As a result, Senator Brownback agreed to withdraw his amendments. The Senate Majority and Minority leaders agreed to bring a free standing stem cell bill to the floor by the end of March 2002. Senator Specter promised more “in depth” hearings on stem cell research and therapeutic cloning, and the other issues raised by Senator Brownback's amendments.

Prepared by Anne Houser/OD/OLPA