THE SECRETARY OF HEALTH ANDO HUMAN SERVICES
WASHINGTON, O.C. 70270)

 

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FED 23 (ose

The Honorable Jay Dickey

U.S. House of Representatives

2453 Rayburn House Office Building
Washington, DC 20515

Dear Mr. Dickey:

Thank you for your letter dated February 11, 1999, conceming the recent announcement by the
Director of the National Institutes of Health (NIU) 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 important ethical issues. Therefore, Dr. Varmnus and his colleagues at the
National Institutes of Health (NIH) will proceed with great caution to ensure that the highest
standards are set before moving forward im this area.

In keeping with the important 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 Committee 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 other interested parties --
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. I am firmly committed to our continued adherence to the law.

Your letter makes specific inquiries regarding a legal memorandum on this subject from the HHS
General Counsel. You suggest that the legal analysis is problematic because it relies on a pew
definition of human embryo that would undermine the Congressional prohibition. In fact, the
memorandum relies on the definition provided in the statute itself. The statute defines human
embryo as “any organism ... that is derived ... from one or more human gametes or diploid cells.”

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FEB-23-1999 10:04 2026987203 P.@2
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The legal memorandum, relying on the scientific definition of the word “organism”, concludes
that the stem cells at issue are not organisms and therefore cannot be considered human embryos

under section 51] of the HHS appropriations law.

The prohibition on federal funding for human embryo research bars the expenditure of federal
funds for the creation of a human embryo for research purposes or for research in which a human
embryo is destroyed, discarded or knowingly subject to greater than minimal risk. You suggest
that this provision should be read to also bar federal funding for research which follows or
depends upon the destruction of or injury to a human embryo. The plain language of the statute
supports the opinion issued by the General Counsel. The law applies by its terms to research in
which “a human embryo or embryos are destroyed, discarded” or subjected to more than minimal
risk, and not to research preceding or following such research projects. Moreover, I have been
advised that there is nothing in the legislative history to suggest that the provision was intended
to prohibit funding for research in which embryos -- organisms -- are not involved.

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, and
bring together the finest minds and facilities to further medical and scientific advances. Allow
me to assure you that the NIH understands and respects the deep convictions of people in the
research, academic and religious 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.

Sincerely,

FEB-23-1999 10:04 2026907203

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