Good morning Mr. Chairman, and members of the subcommittee. My name is Eric Meslin. I am the Executive Director of the National Bioethics Advisory Commission.

I was privileged to appear before your subcommittee on December 2, 1998 to offer some brief remarks on the subject of human stem cell research. At that hearing, Mr. Chairman, I informed the subcommittee that in his November 20th letter to President Clinton, the NBAC Chair, Dr. Harold Shapiro, addressed only the immediate issue of the purported experiment involving the fusion of a cow egg and a human cell, and that NBAC would devote a majority of its next meeting to the broader issue raised by President Clinton in his November 14, 1998 letter to the Commission, namely that NBAC "undertake a thorough review of the issues associated with … human stem cell research, balancing all ethical and medical considerations."

Just this past week NBAC met for the 26th time since being established by President Clinton. The Commission devoted the entire day, January 19th, to the topic of human stem cell research, hearing testimony from a number of leading scientists, bioethicists, theologians, legal scholars, and the public. The purpose of this meeting was to provide NBAC with a deeper understanding of the ethical, scientific, legal, medical, and policy issues that are raised by this important area of research. While the Commission did not reach any immediate conclusions--nor were they expecting to–it may be helpful to describe the range of issues that were discussed, and then to describe our timetable for completing this report.

In our view an understanding of the legal status regarding the use of federal funds to conduct human stem cell research provides an important context for fully understanding the ethical issues. At our recent meeting, NBAC was interested to learn that the Office of the General Counsel of the Department of Health and Human Services has rendered an opinion regarding whether federal funds may be used for research conducted with human pluripotent stem cells derived from embryos created by in vitro fertilization or from primordial germ cells isolated from the tissue of non-living fetuses. We are planning to carefully review this opinion since it provides one of the many pieces of valuable information we will rely on to fully address the bioethical issues involved in this area of research.

In testimony before us, we heard some compelling arguments in favor of permitting research on human stem cells, based principally on the very promising results of previous animal studies. Several beneficial uses of these cells are anticipated, including:

• understanding basic and developmental biology;
• the development of transplantation therapies for the treatment of diseases such as Parkinson’s disease and diabetes;
• the discovery of new drugs; and
• the study of infertility and birth defects.

It was also clear that a number of important scientific issues must be resolved before any actual therapies can be developed or tested in human beings. These issues include:

• how to specifically direct stem cells to differentiate into specific types, such as cardiac muscle or nerve cells;
• how to overcome the problem of immune rejection of such transplanted tissue; and
• how stem cells derived from fetal primordial germ cells (EG cells) differ from stem cells derived from embryonic sources (ES cells), and whether these differences have any functional importance.

We also heard some words of caution, and objection to all forms of research involving the human embryo, the human fetus, or the cells or tissues derived from these sources respectively. Some of these concerns related to the potential for complicity in the use of cells derived from spare or "excess" embryos. Other concerns related to more fundamental objections to the use of human fetal or embryonic material, irrespective of their source or potential for benefit.

The focus of the NBAC effort is to develop sound public policy proposals based on appropriate scientific, medical, ethical, and legal considerations. In this respect, we hope to use the experiences from former deliberative bodies including the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, the DHHS Ethics Advisory Board, the Fetal Tissue Transplantation Research Panel, and the NIH Director’s Embryo Research Panel. We will also be contacting a variety of public, professional, scientific and other organizations seeking their views on these issues. And, as with all NBAC reports, our deliberations, agendas, transcripts and working papers will be available on our website at http://www.bioethics.gov.

In reviewing a working draft outline of the report prepared by my staff, the Commission expressed an interest in developing a report that was focused on a set of answerable and timely questions, but that would also be able to anticipate certain issues. The specific issues our report will address are now being developed for NBAC’s consideration, but they will likely focus on some of the following points:

• Is there an ethically relevant distinction between research using human stem cells derived from fetal material vs. research using human stem cells obtained from existing embryos?
• How should considerations about the source of human stem cells be incorporated into the analysis?
• Is it ethically acceptable to produce new human embryos as a source of stem cells for research?
• What is the appropriate role of the federal government in overseeing research of this kind?

NBAC would hope that one of the results of its deliberations on this topic would be to identify the bioethical issues that ought to be considered when supporting such research, or developing guidelines for reviewing research in this area.

Now let me say a word about our timetable. As you know, Mr. Chairman, NBAC is subject to Federal Advisory Committee Act (1972) which requires that we conduct all of our business in public, and come to conclusions in public. This means that any Commission decisions--be they interim conclusions or final recommendations--can only occur at NBAC meetings. We are committed to completing this report by June 1999, or thereabouts, so NBAC and it staff have mobilized to work as expeditiously as possible. Additional meetings have been scheduled–we will be meeting next week, February 2-3, in Princeton, New Jersey, and monthly thereafter. I should note, however, that the Commission is preparing for the possibility of being able to provide to the President conclusions on certain issues within the next few months. We are aware of NIH’s interest in moving forward with human stem cell research, and Dr. Shapiro has indicated to Dr.Varmus that if NBAC reaches any interim conclusions they will be shared with NIH and others after they are transmitted to the President. Naturally, Mr. Chairman, we will be pleased to provide you and your staff with an update on our work as it proceeds.

I would now be pleased to answer any questions you may have.

1. Materials from NBAC Meeting, January 19-20, 1999

Agenda
Table of Contents
List of Public Testimony

2. List of Future NBAC Meetings
3. Dear colleague letter from Harold T. Shapiro, Ph.D and Eric M. Meslin, Ph.D, dated January 20, 1999
4. Letter to Harold E. Varmus, M.D, from Harold T. Shapiro, Ph.D, dated January 22, 1999