Update on Human Pluripotent Embryonic Stem Cell Research

Prepared by Ida Chow, Feb.'99

What's happening?

Since the recent publication of James Thomson's (ref. 1) and John Gearhart's (ref. 2) groups work on human embryonic stem (ES) cells last November, considerable attention has been given to these cells. Recently, a new dimension has been added to the issue of stem cells in general with the publication of Christopher Bjornson and collaborators' work on adult neural stem cells (ref. 3). Unfortunately, not all of this attention has been positive, for various reasons.

We will try to keep our members informed of the relevant events that take place in the Congress and elsewhere. Following is a summary of where the issue stands now.

-Congress

Consider first the potential benefits this line of research can offer to ameliorating, at the least, and curing at best, many human functional failures and degenerative diseases (ref 4). Based on this bright future, Senators Arlen Specter (R-PA) and Tom Harkin (D-IA) openly expressed their support for allowing Federal funding for human ES cell research. Three hearings of the Senate Appropriation Subcommittee on Labor, Health and Human Services and Education (Sen. Specter, Chair) were held and scientists (including Drs. Thomson, Gearhart and Varmus), lawyers, ethicists, patient and religious groups' representatives presented statements. At these hearings, discussions took place on definitions of words, both scientific and legal. Testimony and transcripts of these hearings are posted on the Senate Appropriations Committee Website at: http://www.senate.gov/~appropriations/labor/test.htm (Dec. 6, 1998, Jan. 12, 1999, Jan. 26, 1999).

NIH Director, Dr. Harold Varmus requested ruling from the Department of Health and Human Services' (DHHS) General Counsel on the legality of Federal funding for human ES cells under the current ban on use of Federal monies for human embryo research. Ms. Harriet Rabb, DHHS General Counsel, stated in her ruling that "The statutory prohibition on the use of funds appropriated to HHS for human embryo research would not apply to research utilizing human pluripotent stem cells because such cells are not a human embryo within the statutory definition." (see Varmus' Jan. 26 Senate testimony in: http://www.senate.gov/~appropriations/labor/test.htm)

While many biomedical sciences and patient advocacy groups applauded the ruling, right-to-life and some religious groups voiced their strong opposition. In the week of Feb. 15, two letters from the Congress were sent to Secretary Donna Shalala, one signed by 80 Representatives (72 Republicans and 8 Democrats) and the other signed by seven Republican Senators, opposing very strongly to the DHHS Counsel's ruling. In their letter, the Representatives stated "Any NIH action to initiate funding of such research would violate both the letter and spirit of the federal law banning federal support for research in which human embryos are harmed or destroyed." They asked Secretary Shalala to "correct the General Counsel's interpretation and to reverse Dr. Varmus' decision." The Senators were "deeply concerned with what appears to be a unilateral attempt on your part to effectively undermine congressional intent, by circumventing the current federal funding ban on embryo research... Congress never intended for the National Institutes of Health to give incentives for the killing of human embryos for the purpose of stem cell research. We are very interested in any further insight you might provide on this issue and look forward to hearing form you soon."

On Feb. 23, at the Senate Appropriations Committee's hearing for NIH and HHS budget, Secretary Shalala reaffirmed her support for human ES cell research by saying: "We believe the General Counsel's opinion is consistent with current law, and we'll continue to rigorously enforce the congressional prohibition on funding for human embryo research. But, as the General Counsel has pointed out quite carefully, the law allows stem cell research, and the promise of this research is extraordinary."

- National Bioethics Advisory Commission

At the same time, President Clinton requested a report on human ES cells from the National Bioethics Advisory Commission, in response to the news that an adult human cell nucleus was transferred into an enucleated cow oocyte and ES cells were also produced. This report was not published in a peer-reviewed journal, and it was given by Michael West, President of Advanced Cell Technology, the biotechnology company that funded the experiment, instead of the scientist authors, to 'a newspaper'. NBAC has held two meetings and heard from scientists, lawyers, ethicists, NIH director, representatives of some patient and religious groups, and individuals from the public at large. (http://www.bioethics.gov) The final report is scheduled to be delivered to the President in June.

-SDB's action

SDB has sent letters to Senators Specter, Harkin and Director Varmus, as well as to NBAC, supporting the ruling on Federal funding for human ES cell research (letter to Senators). This support will allow more scientists to contribute to more rapid resolution of important and basic developmental questions. Moreover, it will enforce strict Federal oversight and review process so that only the most meritorious projects will be allowed and will be funded. In addition, the dissemination of information and the sharing of biological materials will also be more open and accessible to all investigators, and not only to a privileged few, as it would be the case of private funding. Past experience has shown that many material transfer agreements between academia and private industry have been cumbersome for the advancement and dissemination of new scientific knowledge.

SDB Board of Trustees has also appointed a committee to respond in a timely manner to requests for information and scientific opinions on public issues relevant to Developmental Biology made from the government, other public and educational organizations, and SDB members. The Public Information Committee members are Janet Rossant (Chair), Roger Pedersen, Brigid Hogan and John Eppig.

SDB Members are welcome to contribute their thoughts on the science, politics and/or ethics aspects of this issue: this issue. Please email opinions to: [email protected], and write "ES Cells" in the "SUBJECT" line of the address.

References (not intended to be complete or exhaustive):

1. Thomson, J.A. et al. 1998. Science 282: 1145-1147.

2. Shamblott, M.J. et al. 1998. Proc. Natl. Acad. Sci. USA 95: 13726-13731

3. Bjornson, C.R.B et al. 1999. Science 283: 534-537. Also see commentaries in the same issue: 465-467 and 471.

4. Pluripotent Stem Cells: A Primer - http://www.nih.gov/news/stemcell/primer.htm

Stem Cell Press Kit - http://www.news.wisc.edu/emediakit/release.html

Stem Cell Research: Should Federal Funding Apply? - http://www.fundingfirst.org/comment/16/index.html

Rossant, J. & Nagy, A., 1999. Nature Biotech 17:23-24

Pedersen, R., 1999. Scientific American April issue

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