Sen. Bill Frist statement on stem cells

On August 9, 2001, shortly after I outlined my principles (Cong. Rec. 18 July 2001: S7846-S7851), President Bush announced his policy on embryonic stem cell research. His policy was fully consistent with my ten principles, so I strongly supported it. It federally funded embryonic stem cell research for the first time. It did so within an ethical framework. And it showed respect for human life.

But this policy restricted embryonic stem cell funding only to those cell lines that had been derived from embryos before the date of his announcement. In my policy I, too, proposed restricting number of cell lines, but I did not propose a specific cutoff date. Over time, with a limited number of cell lines, would we be able to realize the full promise of embryonic stem cell research?

When the President announced his policy, it was widely believed that 78 embryonic stem cell lines would be available for federal funding. That has proven not to be the case. Today only 22 lines are eligible. Moreover, those lines unexpectedly after several generations are starting to become less stable and less replicative than initially thought (they are acquiring and losing chromosomes, losing the normal karyotype, and potentially losing growth control). They also were grown on mouse feeder cells, which we have learned since, will likely limit their future potential for clinical therapy in humans (e.g., potential of viral contamination).

While human embryonic stem cell research is still at a very early stage, the limitations put in place in 2001 will, over time, slow our ability to bring potential new treatments for certain diseases. Therefore, I believe the President’s policy should be modified. We should expand federal funding (and thus NIH oversight) and current guidelines governing stem cell research, carefully and thoughtfully staying within ethical bounds.

During the past several weeks, I’ve made considerable effort to bring the debate on stem cell research to the Senate floor, in a way that provided colleagues with an opportunity to express their views on this issue and vote on proposals that reflected those views. While we have not yet reached consensus on how to proceed, the Senate will likely consider the Stem Cell Research Enhancement Act, which passed the House in May by a vote of 238 to 194, at some point this Congress. This bill would allow federal funding of embryonic stem cell research for cells derived from human embryos that:

1. are created for the purpose of fertility treatments;

2. are no longer needed by those who received the treatments;

3. would otherwise be discarded and destroyed;

4. are donated for research with the written, informed consent of those who received the fertility treatments, but do not receive financial or other incentives for their donations.

The bill, as written, has significant shortcomings, which I believe must be addressed.

First, it lacks a strong ethical and scientific oversight mechanism. One example we should look to is the Recombinant DNA Advisory Committee (RAC) that oversees DNA research. The RAC was established 25 years ago in response to public concerns about the safety of manipulation of genetic material through recombinant DNA techniques. Compliance with the guidelines (developed and reviewed by this oversight board of scientists, ethicists, and public representatives) is mandatory for investigators receiving NIH funds for research involving recombinant DNA.

Because most embryonic stem cell research today is being performed by the private sector (without NIH federal funding), there is today a lack of ethical and scientific oversight that routinely accompanies NIH-(federal) funded research.

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