Government funding


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Public Affairs 678.01

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Government funding

  2. 2. QUESTION:Should stem cell research be funded by the government or through public and/or private funding?
  3. 3. History Stem cells are cells found in all multi-cellular organisms, which includes humans. They were first isolated in mice in 1981 and in humans in 1988.
  4. 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 Parkinson’s disease.
  5. 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. 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. 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. 8. Embryonic stem cells from IVF Embryos orfetal tissue Embryonic stem cells were first isolated from mouse embryos in 1981 and from primate embryos in 1995. Animal embryos were the only source for research on embryonic stem cells until November 1998. The cells were derived from five day old embryos produced via in vitro fertilization. (IVF)
  9. 9. Cont. This work is controversial because the stem cells are located within the embryo and the process of removing them destroys the embryo. The cells have also been derived from the properties from five-to nine week old embryos or from fetuses obtained through elective abortion .
  10. 10. Embryonic Stem Cells Obtained via SCNT(Cloning) Another potential source of embryonic stem cells is somatic cell nuclear transfer (SCNT), also referred to as cloning. Stem cells derived from cloned embryos may offer the best hope for understanding and treating disease. The nucleus of the egg is removed and replaced by the nucleus from a mature body cell, such as a skin cell from a patient.
  11. 11. Stem Cells from Adult Tissue or UmbilicalCord Blood A January 2007 report found cells can be found in amniotic fluid.
  12. 12. Potential Applications of Stem Cell Research Stem cells provide the opportunity to study the growth and differentiation of individual cells in tissues. Understanding these processes could provide insights into the causes of birth defects, genetic abnormalities, and other disease states. If normal development were better understood, it might be possible to prevent or correct some of these conditions.
  13. 13. Cont. Stem cells can be used to produce large amounts of one cell type, to test new drugs for effectiveness and chemicals and toxicity. Stem cells might be transplanted into the body and treat disease (diabetes, Parkinson’s disease) or injury (e.g., spinal cord)
  14. 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. 15. Cont. Under the amendment (a) None of the funds made under the Dickey Act may be used for…….(1) The creation of a human embryo or embryos for research purposes; or(2) research in which a human embryo or embryos are destroyed or discarded, or knowingly subjected to risk or injury or death greater than that allowed for research on fetuses in utero.
  16. 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. 17. Peter Griffin visits stem cell research lab etailpage&v=TRtlkcQ6brE
  18. 18. Administration Policies Clinton Administration Stem Bush Adminstration Stem Cell cell Policy Policy Research in which human stem cells are  On August 9,2001, President Bush utilized to create or contribute to a human announced for the first time federal embryo funds would be used to support Research in which human cells are research on embryonic stem combined with an animal embryo cells, but funding would be limited Research in which human stem cells are to “existing stem cell lines where life used for reproductive cloning of a human and death decisions had already Research in which human stem cells are been made. derived using somatic cell nuclear transfer  (1) with the informed consent of Research utilizing human stem cells that donors were derived using somatic cell nuclear transfer  (2) from excess embryos created Research utilizing stem cells that were solely 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. 19. Administration Policies Cont… In March of 2009 President Obama signed an executive order repealing a Bush-era policy that limited federal tax dollars for embryonic stem cell research. Obama’s repeal overturns an order signed by President Bush in 2001 that barred the National Institutes of Health from funding research on embryonic stem cells beyond using 60 cell lines that existed at the time.
  20. 20. Administration Policies cont.. Obama also signed a presidential memorandum establishing greater independence for federal science policies and programs. Obama’s 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 Obama’s actions.
  21. 21. Federal Funds Federal Funds would not be used for: (1) the derivation or use of stem cell lines derived from newly destroyed embryos. (2) the creation of any human embryos for research purposes (3) the cloning of human embryos for any purpose.
  22. 22. Regulation of Stem Cell Research NIH Research funding and FDA Regulation Stem Cell Registry. The FDA defines “xenotransplantation” as any procedure that involves the tranpltation, implantation, or infusion into a human recipient of either (a) live cells, tissues, or organs from a nonhuman source (b) human body fluids, cells, tissues or organs that have had ex vivo contact with nonhuman animal cells, tissues or organs. Under FDA guidelines, transplantation therapy involving Bush approved stem cell lines, which have all been exposed to mouse feeder cells, would constitute xenotransplantation.
  23. 23. Private vs. Public FundingPublic Funding Private Funding Public funding can  An advantage of private contribute to sound funding is that it allows policy by increasing the research to proceed even probability that the if it’s a politically touchy issue. results of stem cell  (In the US, only private research will reflect funded companies are social priorities that may allowed to perform not inform research in research on embryonic the private sector. or fetal stem cells)
  24. 24. Private vs. Public Funding cont.Public Funding Private Funding Many Americans including  The private sector can children are excluded from the U.S. health care compensate for system. Public funding fluctuations in offer s the best hope of fostering public government consideration for common spending, and more good, rather than marketplace concerns, and importantly, and can of expanding access to the move forward without fruits of stem cell research for a large number of any federal funding. Americans.
  25. 25. Private vs. Public Funding cont.Public Funding Private Funding Stem cell research is more  Privately funded likely to advance if canonical genetic stokes of lavatories have made ES cells are made available large technical to the scientific community. Public advancement s in stem funding under the auspices cell research. of federal agencies is the only effective means for ensuring equal access by scientists to standardized ES cell lines
  26. 26. Federal Funding The federal government is the only realistic source for such an infusion of funds. The government can strictly monitor the practices of public research through federal funding. The commitment of federal funds also offer a basis for public review, approval and, in monitoring through well established procedures that will promise the public’s interest in ensuring that stem cell research is conducted in a way that is both scientifically rigorous and ethically proper.
  27. 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 cell technology will require a large and sustained investment in research. The federal government is the only realistic source for such infusion of funds.
  28. 28.  Recommendation (2) Public funding should be provided for embryonic stem cell research, but not at this time for activities involved in the isolation of embryonic stem cells, for which there remains continuing debate. This approach will allow publically- funded researchers to move more quickly toward discoveries that will lead to alleviating the suffering caused by human disease.  Although the derivation of human stem cells can be done in an ethical manner, there is enough objection to the process of deriving stem cells in a ethical manner, to recommend against its public funding. Further for the foreseeable future there will be sufficient material isolated by researchers not using public funding that this exclusion will not have a negative impact on research.
  29. 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 the advancement of research on stem cells. The leadership exhibited by the company that has sponsored all of the published human embryonic and germ cell research to date in establishing an external Ethics Advisory Board to develop guidelines for ethical conduct of such research is positive. While these private sector boards are not a substitute for public oversight and guidance, they can be a positive influence on the way that industry-funded stem cell research proceeds.