1.GOVERNMENT FUNDING VS.PUBLIC AND PRIVATE FUNDINGFOR STEM CELL RESEARCHBy Ariane N. Davis

2. QUESTION:Should stem cell research be funded by the government or through public and/or private funding? 3. History Stem cells are cells found in all multi-cellularorganisms, which includes humans. They were first isolated in mice in 1981 and inhumans in 1988. 4. Stem Cells Research Embryonic cells have the ability to develop into virtually any cell in the body, and have the potential to treat medical conditions such as diabetes and Parkinsons disease. 5. Stem Cell Research cont. Some have argued that adult stem cells (from bone marrow or umbilical cord blood) should be pursued instead of embryonic cells because they believe the derivation of stem cells from embryos is ethically unacceptable. 6. Stem Cell Research cont. Stem cells retain the ability to become some or all of the more than 200 different cell types in the body, and thereby play a critical role in repairing organs and body tissues throughout life. 7. Stem Cell research cont. Embryonic stem cells may have a greater ability to become different types of body cells than adult stem cells. 8. Embryonic stem cells from IVF Embryos orfetal tissue Embryonic stem cells were first isolated frommouse embryos in 1981 and from primate embryosin 1995. Animal embryos were the only source for researchon embryonic stem cells until November 1998. The cells were derived from five day old embryosproduced via in vitro fertilization. (IVF) 9. Cont. This work is controversial because the stem cellsare located within the embryo and the process ofremoving them destroys the embryo. The cells have also been derived from theproperties from five-to nine week old embryos orfrom fetuses obtained through elective abortion . 10. Embryonic Stem Cells Obtained via SCNT(Cloning) Another potential source of embryonic stem cellsis somatic cell nuclear transfer (SCNT), alsoreferred to as cloning. Stem cells derived from cloned embryos may offerthe best hope for understanding and treatingdisease. The nucleus of the egg is removed and replaced bythe nucleus from a mature body cell, such as a skincell from a patient. 11. Stem Cells from Adult Tissue or UmbilicalCord Blood A January 2007 report found cells can be found in amniotic fluid. 12. Potential Applications of Stem Cell Research Stem cells provide the opportunity to study thegrowth and differentiation of individual cells intissues. Understanding these processes couldprovide insights into the causes of birth defects,genetic abnormalities, and other disease states. If normal development were better understood, itmight be possible to prevent or correct some ofthese conditions. 13. Cont. Stem cells can be used to produce large amounts ofone cell type, to test new drugs for effectivenessand chemicals and toxicity. Stem cells might be transplanted into the bodyand treat disease (diabetes, Parkinsons disease) orinjury (e.g., spinal cord) 14. Current Regulations The Dickey AmendmentPrior to an August 2001 Bush Administration decision, no federal funds had been used to support research on stem cells derived from either human embryos or fetal tissue. 15. Cont. Under the amendment (a) None of the funds made under the Dickey Actmay be used for.(1) The creation of a human embryo or embryos forresearch purposes; or(2) research in which a human embryo or embryosare destroyed or discarded, or knowinglysubjected to risk or injury or death greater thanthat allowed for research on fetuses in utero. 16. Cont. (b) The term embryo or embryos includes any organism, not protected as a human under 45 CFR [the Human Subject Protection regulations} as of the date of enactment of this Act, that is derived by fertilization, parthenogenesis, cloning or any other means from one or more human gametes [sperm or egg] or human diploid cells {cells that have two sets of chromosomes, such as somatic cells] 17. Peter Griffin visits stem cell research lab http://www.youtube.com/watch?feature=player_d etailpage&v=TRtlkcQ6brE 18. Administration PoliciesClinton Administration Stem Bush Adminstration Stem Cellcell Policy Policy Research in which human stem cells are On August 9,2001, President Bush utilized to create or contribute to a humanannounced for the first time federal embryofunds would be used to supportResearch in which human cells areresearch on embryonic stem combined with an animal embryo cells, but funding would be limitedResearch in which human stem cells are to existing stem cell lines where life used for reproductive cloning of a human and death decisions had alreadyResearch in which human stem cells are been made. derived using somatic cell nuclear transfer (1) with the informed consent ofResearch utilizing human stem cells that donors were derived using somatic cell nuclear transfer (2) from excess embryos createdResearch utilizing stem cells that weresolely for reproductive purposes derived from human embryos created for research purposes, rather than for infertility (3) without any financial treatment. inducements to the donors. 19. Administration Policies Cont In March of 2009 President Obama signed anexecutive order repealing a Bush-era policy thatlimited federal tax dollars for embryonic stem cellresearch. Obamas repeal overturns an order signed byPresident Bush in 2001 that barred the NationalInstitutes of Health from funding research onembryonic stem cells beyond using 60 cell linesthat existed at the time. 20. Administration Policies cont.. Obama also signed a presidential memorandum establishing greater independence for federal science policies and programs. Obamas order directs the NIH to develop revised guidelines on federal funding for embryonic stem cell research within 120 days of the original memorandum. The federal Courts upheld Obamas actions. 21. Federal Funds Federal Funds would not be used for: (1) the derivation or use of stem cell lines derivedfrom newly destroyed embryos. (2) the creation of any human embryos forresearch purposes (3) the cloning of human embryos for any purpose. 22. Regulation of Stem Cell Research NIH Research funding andFDA Regulation Stem Cell Registry. The FDA defines xenotransplantation asany procedure that involves thetranpltation, implantation, or infusion intoa human recipient of either (a) live cells, tissues, or organs from anonhuman source (b) human body fluids, cells, tissues ororgans that have had ex vivo contact withnonhuman animal cells, tissues or organs. Under FDA guidelines, transplantationtherapy involving Bush approved stem celllines, which have all been exposed tomouse feeder cells, would constitutexenotransplantation. 23. Private vs. Public FundingPublic FundingPrivate Funding Public funding can An advantage of private contribute to soundfunding is that it allows policy by increasing the research to proceed even probability that the if its a politically touchyissue. results of stem cell (In the US, only private research will reflectfunded companies are social priorities that mayallowed to perform not inform research in research on embryonic the private sector.or fetal stem cells) 24. Private vs. Public Funding cont.Public FundingPrivate Funding Many Americans including The private sector can children are excluded from the U.S. health carecompensate for system. Public fundingfluctuations in offer s the best hope of fostering publicgovernment consideration for commonspending, and more good, rather than marketplace concerns, and importantly, and can of expanding access to themove forward without fruits of stem cell research for a large number of any federal funding. Americans. 25. Private vs. Public Funding cont.Public FundingPrivate Funding Stem cell research is more Privately fundedlikely to advance ifcanonical genetic stokes oflavatories have madeES cells are made availablelarge technicalto the scientificcommunity. Publicadvancement s in stemfunding under the auspices cell research.of federal agencies is theonly effective means forensuring equal access byscientists to standardizedES cell lines 26. Federal Funding The federal government is the only realistic sourcefor such an infusion of funds. The government can strictly monitor the practicesof public research through federal funding. The commitment of federal funds also offer a basisfor public review, approval and, in monitoringthrough well established procedures that willpromise the publics interest in ensuring that stemcell research is conducted in a way that is bothscientifically rigorous and ethically proper. 27. Recommendations Recommendation (1) Federal funding for stem cell research is necessary in order to promote investment in this promising line of research, to encourage sound public policy, and to foster public confidence in the conduct of such research. Realizing the potential health benefits of stem celltechnology will require a large and sustainedinvestment in research. The federal government is theonly realistic source for such infusion of funds. 28. Recommendation (2) Public funding should be provided for embryonic stem cellresearch, but not at this time for activities involved in theisolation of embryonic stem cells, for which there remainscontinuing debate. This approach will allow publically-funded researchers to move more quickly towarddiscoveries that will lead to alleviating the suffering causedby human disease. Although the derivation of human stem cells can be done in anethical manner, there is enough objection to the process ofderiving stem cells in a ethical manner, to recommend againstits public funding. Further for the foreseeable future there willbe sufficient material isolated by researchers not using publicfunding that this exclusion will not have a negative impact onresearch. 29. Recommendation (3) The formation of company-based independent ethics advisory boards should be encouraged in the private sector. Private sector research has played a crucial part in theadvancement of research on stem cells. The leadershipexhibited by the company that has sponsored all of thepublished human embryonic and germ cell research todate in establishing an external Ethics Advisory Board todevelop guidelines for ethical conduct of such research ispositive. While these private sector boards are not asubstitute for public oversight and guidance, they can be apositive influence on the way that industry-funded stemcell research proceeds.