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Managing America: Health

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Week Ending April 13, 2006

S.30 A bill to intensify research to derive human pluripotent stem cell lines.

The ultimate goals of this bill are to create an amniotic and placental stem cell bank and prohibit use of fetal stem cells for research with a small exception.

The bill’s purpose is defined as an act to intensify research that may result in improved understanding of or treatments for diseases and other adverse health conditions and to promote deriving stem cells from amniotic fluid and placentas without the creation of human embryos for research purposes and without destructing or discarding, risking or injuring a human embryo that is not naturally dead. Cells from naturally dead embryos may be harvested.

The bill defines ‘naturally dead’ as “… having naturally and irreversibly lost the capacity for integrated cellular division, growth, and differentiation that is characteristic of an organism, even if some cells of the former organism may be alive in a disorganized state.” The bill does not address how the embryo may have died but is explicit in assuring that it did not die as a result of being created for the purpose of stem cell harvesting or a procedure for harvesting the amniotic or placental stem cells

The Secretary of Health and Human Services is directed to conduct and support research under those parameters. The research would aim to develop techniques for isolating, deriving, producing or testing stem cells that may result in improved understanding of or treatments for diseases and other adverse health conditions. The bill requires that the isolation, derivation, production or testing of the cells will not involve the creation of a human embryo(s) for research purposes or the destruction or discarding or risk of injury to embryos other than those that are naturally dead.

In 90 days after enactment of this bill the Secretary would consult with the Director of the National Institute for Health and issue final guidelines that provide guidance concerning the next steps required for additional research. The Secretary will report if additional animal research is required to ensure research involving human cells would be consistent with the law. The Secretary will also prioritize research with the greatest potential for near-term clinical benefit and take into account techniques outlined by the President’s Council on Bioethics and other appropriate techniques and research. In one year the Secretary will report to Congress on the status of activities carried out under this bill.

Research involving cells taken from a naturally dead embryo requires assurances from grant applicants that no alteration of the timing, methods, or procedures used to create, maintain of intervene in the development of the embryo was made solely for the purpose of deriving the stem cells.

The proposed stem cell bank is to be structured to maximize the potential of collecting, storing, standards setting, information sharing, distribution, reimbursement, research, and outcome measures with expert oversight. A report would be due Congress in 180 days of enactment.

Sponsor:  Senator Norm Coleman (R-MN)

Vote:

Cost to the taxpayers: No discernible cost.

Earmark Certification:   Not applicable to this bill.

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