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Stem Cell Research Funding AppendixD

Stem Cell Research Funding AppendixD

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Published by Peggy Satterfield

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Published by: Peggy Satterfield on Jul 27, 2012
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114 ~ The New Atlantis
Copyright 2012. All rights reserved. See www.TheNewAtlantis.com for more information.
T
he central policy question in the United States relating to humanembryonic stem cell research has not been its legality. While severalstate legislatures have addressed measures that would limit or ban humanembryonic stem cell research, the central policy focus at the federal levelhas been whether and how such research would receive federal funding.No one has a right to receive federal funding. The people, projects,and activities that receive federal taxpayer dollars do so as a matter of explicit policy decisions. In our democratic system, decisions about fund-ing rightly take into account not only material costs and benefits but alsomoral judgments.
1
In the stem cell debates, this has meant balancing the public interestin finding new cures and treatments part of our longstanding publicconsensus in support of practical scientific research generally againstthe profound ethical problems raised by the research.
Policymakers Face the Embryo
T
he policy debate over funding human embryonic stem cell research wasnot wholly unprecedented. Scientists began experimenting on human fetaltissue as early as the 1930s; by the 1960s, a handful of non-therapeuticexperiments had begun on “previable human fetuses” still-living fetusesthat had been obtained by spontaneous and induced abortions.
2
In the1970s, researchers became more interested in using fetal tissue for clinicalpurposes. They hoped that if fetal tissue were implanted into the brainsof patients with degenerative diseases such as Alzheimer’s, Parkinson’s,or Huntington’s, there might be new growth of some of the brain tissuewhose absence or defectiveness had caused the disease. The rapidly ris-ing rate of abortions following the United States Supreme Court’s 1973
Roe v. Wade 
decision
3
may have encouraged scientific interest in thesepossibilities.During the administrations of Ronald Reagan and George H.W. Bush,no federal funding supported such research, and attempts by Democratic-controlled Congresses to fund it were blocked (although privately
Appendix D
Stem Cell Research Funding:Policy and Law
 
Winter 2012 ~ 115Appendix D: Stem Cell Research Funding: Policy and Law
Copyright 2012. All rights reserved. See www.TheNewAtlantis.com for more information.
funded fetal-tissue-transplant experiments proceeded). But PresidentClinton on January 23, 1993 just days after he took office directedthe Department of Health and Human Services (HHS) to lift the Bushadministration’s moratorium on fetal-tissue research. On June 10, 1993,the Democratic-controlled Congress passed the National Institutes of Health Revitalization Act, which permitted federal funding for researchon fetal transplantation, provided that the tissues came from miscarriedor aborted fetuses that were donated with the mother’s consent.
4
The actalso included provisions intended to prevent the purchasing or commer-cialization of fetal tissue.The lifting of the moratorium opened the door for government fund-ing of research on
ex utero 
embryos created by IVF, although researchon embryos
in utero 
was still prohibited under federal regulations for theprotection of human subjects.On February 2, 1994, the NIH established the Human EmbryoResearch Panel (HERP) as an ethics advisory body to provide recommen-dations on human embryonic research. In a report published September27, 1994, the panel recommended funding research on human embryoscreated either for fertility treatments or specifically for the purposes of research.
5
But there was widespread public unease over the research,including a voluminous negative public response submitted to the panel;so, just hours after the HERP report was released, President Clintonrejected part of its recommendations, saying, “I do not believe that fed-eral funds should be used to support the creation of human embryos forresearch purposes, and I have directed that NIH not allocate any resourcesfor such research.”
6
In the wake of this controversy, and following the 1994 electionthat brought Republican majorities to the House and Senate, Congresspassed the Dickey-Wicker Amendment in 1995, named for its authors,Representatives Jay Dickey (R.-Ark.) and Roger Wicker (R.-Miss.). Theamendment a rider on the annual appropriations bill for HHS, whichfunds the NIH prohibited federal funding for research that involvesthe creation or destruction of human embryos. The original amendmentforbade funding for:
(1) the creation of a human embryo or embryos for research purposes;[and](2) research in which a human embryo or embryos are destroyed, dis-carded, or knowingly subjected to risk of injury or death greater thanthat allowed for research on fetuses in utero under 45 CFR 46.208(a)(2)
 
116 ~ The New AtlantisWitherspoon Council on Ethics and the Integrity of Science
Copyright 2012. All rights reserved. See www.TheNewAtlantis.com for more information.
and 42 U.S.C. 289g(b) [federal statutes relating to the protection of human subjects and fetuses specifically].For purposes of this section, the phrase “human embryo or embryos”shall include any organism, not protected as a human subject under45 CFR 46 as of the date of enactment of this Act, that is derived byfertilization, parthenogenesis, cloning, or any other means from one ormore human gametes.
7
Ever since 1995, under presidents and congressional majorities of bothparties, the Dickey-Wicker Amendment has been included in the annualappropriations legislation with largely the same language and purpose; itremains in effect to the present day. (The only non-trivial change to thelanguage of the amendment appeared starting in 1997, when the defini-tion of embryos was expanded to include organisms “derived...from oneor more...human diploid cells” a change presumably prompted by theannouncement of the creation of Dolly the cloned sheep in early 1997.
8
)In January 1999, two months after the announcement in
Science 
thatJames Thomson had (using private funding) derived human ES cells,Harriet Rabb, the lead legal counsel for HHS, issued a memo advisingthe director of the NIH that the Dickey-Wicker ban on federal fundingfor embryo-destructive research would not apply to pluripotent stem celllines “because such cells are not a human embryo within the statutorydefinition.”
9
The Rabb memo thus drew an implicit distinction betweenthe destruction of human embryos and the research that relies on theproducts of that destruction; federal funding for the former remained ille-gal, but funding for the latter was deemed permissible. This distinctionwould become central to the federal stem cell policies that followed.Later that year, on September 7, 1999, the National Bioethics AdvisoryCommission (NBAC) published a report recommending that federal fund-ing be permitted for research on embryonic stem cell lines, as well as forthe derivation of new stem cell lines from unused embryos.
10
Notably, theNBAC report rejected the Rabb memo’s implicit conclusion that researchmaking use of ES cells is ethically distinct from the process that derivesthem from embryos:
An ethical problem is presented in trying to separate research in whichhuman ES cells are used from the process of deriving those cells,because doing so diminishes the scientific value of the activities receiv-ing federal support. This division under which neither biomedicalresearchers at NIH nor scientists at universities and other research

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