Letter to National Academies Regarding Balance on Human Embryonic Stem Cell Research Advisory Committee

Dear Dr. Cicerone, Dr. Fineberg, Dr. Pope, Dr. Sharples, and Dr. Fagen:

We are writing to express concern about the composition of the National Academies Human Embryonic Stem Cell Research Advisory Committee. While we applaud the National Academies for taking leadership in the critical area of human embryonic stem cell research (hESCR) oversight, we feel that the composition of the new committee lacks needed balance, both in terms of areas of expertise and in terms of viewpoint.

The Center for Genetics and Society (CGS) is a nonprofit information and public affairs organization working to encourage responsible uses and effective societal governance of the new human genetic and reproductive technologies. The Integrity in Science Project at the Center for Science in the Public Interest (CSPI) is a consumer advocacy organization that encourages policy-makers at all levels of government to seek balance on expert advisory committees.

The emerging technologies of hESCR and, particularly, somatic cell nuclear transfer (SCNT) raise a number of challenges for society and for potential regulators. Of course, these techniques hold potential to improve human well being. But they also hold potential for harm. For example, SCNT requires human eggs, and women could be harmed or exploited in the egg collection process. Furthermore, the current need for women's eggs indicates that any stem cell or SCNT therapies are likely to be extremely expensive, and likely out of reach of many Americans. In addition, these techniques lay the technological groundwork for applications such as human reproductive cloning and inheritable genetic modification that are widely seen as unacceptable.

The proposed members of the committee bring a wealth of experience in the biological sciences and health law. However, given the nature of hESCR and SCNT, we believe that a number of critical perspectives and backgrounds are inadequately represented.

The predecessor to this committee expressed qualified support for hESCR and SCNT, yet eschewed any federal regulatory role for these emerging technologies. The UK, Canada, and many European countries have taken a very different approach. Though their approaches are dissimilar in some respects, they have all established comprehensive oversight and regulation of hESCR and related technologies. Since the proposed panel contains a number of members who served on the previous panel, it would serve the interests of a full debate on oversight issues if lawyers, bioethicists, public health experts, or policy experts who have expressed caution and a need for effective public oversight, including formal structures of federal regulation, were added to the committee.

We also suggest that the committee include experts with a professional background in the provision of women's health. The women who provide eggs for SCNT will, in a sense, be the first research subjects of stem cell investigations. Their well-being must be protected. And while lawyers and bioethicists bring one needed perspective to these issues, someone whose primary focus is the well-being of women who may provide eggs for research is currently absent from this committee.

Finally, the committee should include experts who will bring a demonstrated research experience and concern for access to health care for ethnic minorities and the economically vulnerable. If treatments based on stem cells, and even more so any that rely on SCNT, turn out to be as expensive as some experts predict, then stem cell-related scientific and technological developments may exacerbate existing health care inequities. Legal and policy questions governing intellectual property or the relationship between government funding and pricing may come before this committee and could significantly shape the extent to which equitable public access to these technologies can be ensured.

Will such discussions be balanced? The current committee is co-chaired by Richard O. Hynes, who sits on Genentech's Scientific Resource Board, and includes Harold Shapiro, a director of Dow Chemical who also sits on the Merck Vaccine Advisory Board, and John Wagner, whose research has been funded by Viacell and Athersys. Their presence ensures that industry's concerns will be adequately represented when such deliberations occur. While there are at least two bioethicists on this panel, we recommend you add at least one person whose research and writing suggest a concern for ensuring public access to leading-edge medical technologies like those that may result from stem cell research.

In the current politically polarized climate, the controversies over hESCR and SCNT are too often portrayed as full support versus complete opposition. But an increasing number of scientists, health law experts, and public-interest advocates have taken a more nuanced approach, and opinion surveys that probe public attitudes reveal a mix of support and legitimate concerns. In particular, we feel that technologies with such potential for both good and harm, such as SCNT, call for moving forward with an attitude of cautious optimism and under a well-regulated system of responsible oversight.

Including this perspective on the committee would give it a balance that it currently lacks. We believe that the committee would be stronger, and the recommendations it issues more credible, if its composition reflected this perspective as well as the one that currently dominates the membership.

Sincerely,

Marcy Darnovsky, Ph.D.
Associate Executive Director
Center for Genetics and Society

Merrill Goozner
Director
Integrity in Science Project
Center for Science in the Public Interest