THE SECRETARY OF HEALTH AND HUMAN SERVICES
WASHINGTON, O.C. 20201

 

The Honorable Don Nickles MAR 2 999

United States Senate
133 Hart Senate Office Building
Washington, DC 20510

Dear Senator Nickles:

Thank you for your letter dated February 11, 1999, conceming the recent announcement by the
Director of the National Institutes of Health (NIH) regarding federal funding for research
utilizing human pluripotent stem cells. As you know, this research has the potential to lead to
great progress in our treatment of debilitating and deadly diseases, Our understanding of human
development and our ability to develop and test new drugs. Stem cell research is richly
promising, yet raises : onortant ethical issues. Therefore, Dr. Varmus and his colleagues at the
National Institutes of Health (NIE) will proceed with great caution to ensure that the highest
standards are set before moving forward in this area.

In keeping with the significant ethical concerns that must be considered, the NIH plans to
proceed in a careful and deliberate fashion to develop rigorous guidelines. A working group of
the Advisory Committes to the Director of NIH will develop guidelines for the conduct of
research using pluripotent stem cells and will recommend an oversight mechanism for protocol
review. The National Bioethics Advisory Commission is studying these issues and will provide
us with advice that -- together with counsel from outside experts, Congress and the public —- will
help ensure appropriate oversight.

First and foremost, these guidelines will ensure that any research funded in this area is consistent
with the prohibition on federal funding for human embryo research contained in section 511 of
the HHS appropriations law. Since this prohibition was first enacted in 1996, the Department of
Health and Human Services (HHS) has conscientiously adhered to its strictures. For example,
we have included the restriction on the use of funds in the NIH Grants Policy Statement and have
issued notices reminding NIH intramural staff and the extramural research community that they
must observe the prohibition. When necessary, we have not and will not hesitate to take
appropriate enforcement action. 1 am firmly committed to our continued adherence to this law.

You have asked whether pluripotent stem cells may come together in culture to begin developing
as anembryo. The scientific knowledge base about pluripotent stem cells comes from years of
experience in animal research. Mouse pluripotent stem cells grown in a petri dish can give rise to
specialized cells and tissues which sometimes form an ageregated structure, similar to certain
tumors of the ovary and testis, termed an “embryoid body.” These mouse embryoid bodies,
however, are not embryos. Similarly, in one report on the derivation of human pluripotent stem
cells, researchers observed that the human pluripotent stem cells can form embryoid bodies that
are similar in structure to mouse embryoid bodies, which, as noted above, are not embryos.

164 909

MAR-@2-1999 17:58 o7% P.e2
Page 2- The Honorable Don Nickles

I have reviewed our Department’s position and am reassured that proceeding cautiously with
research on existing pluripotent stem cell lines is both legal and appropriate. Further, it will
allow the NIH to foster world-class research on stem cells, assure appropriate oversight of such
research, and bring together the finest minds and facilities to further medical and scientific
advances. J assure you that the NIH understands and respects the deep convictions of people in
the academic, religious and bioethics communities, and in Congress, and intends to seek the
advice and comment of those communities as we move ahead. I look forward to working with
you to ensure that the legal and ethical issues involved in this extremely promising area of

research are addressed.

 

Donna E. Shalala

MAR-@2-1999 17:58 on
° P.@3