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  • 1.
  • 2.
  • 3. Life, Death, and Stem Cell Research
    Richard L. Elliott, MD, PhD, FAPA
    Director, Medical Ethics
    Professor, Internal Medicine
    Mercer University School of Medicine
    Adjunct Professor
    Mercer University School of Law
  • 4. Goals
    Background
    Timeline
    Principles of medical ethics
    Sources and fate of stem cells
    Potential therapeutic uses and abuses
    Access to results
    Ethics and IVF
    Preimplantation Genetic Determination
    IVF, RU486, IUDs
    Cloning
  • 5. Recent Timeline
    1978 Louise Brown IVF
    1996 Dolly the sheep
    1998 First human embryonic stem cells
    2001 Federal funding for stem cell research limited to existing stem cell lines
    2004 South Korean researchers claim first human cloned to generate stem cells
    2007 Reprogramming of fibroblasts into stem cells
    2009 Executive order reversed previous ban on federal funding for new embryonic stem cell lines
  • 6. Principles of Medical Ethics
    Autonomy
    Informed consent of gamete donors, parents around fate of embryos
    Beneficence
    Potential therapeutic uses of hESC cell research
    Non-maleficence
    Harm to embryos
    Social justice
    Who will benefit? Will all have access to uses?
  • 7. Sources of Stem Cells
    Existing stem cell lines
    Pre-2009 18 hESC lines approved for study using federal funding
    Unused embryos from IVF
    2010 43 approved hESC lines, 115 submitted for review. But only one line from pre-2009 lines approved thus far
    Programmed adult skin cells (iPSC)
    Umbilical cord blood
    Amniotic fluid cells
    Bone marrow
    Fetal tissue
    Somatic cell nuclear transfer
  • 8. In Vitro Fertilization
  • 9. IVF – In Vitro Fertilization
  • 10. Ethical Issues and IVF-Derived hESCs
    Weighing harm to embryos vs potential benefits
    Informed consent
    hESCsand personhood
    Federal funding for hESCresearch
  • 11. Beneficence and Therapeutic Potential
  • 12.
  • 13. First FDA-approved Clinical Trial Using hESCs
    January 2009
    Geron
    Spinal cord injury
  • 14. Autonomy, NIH, Informed Consent, and hESCs
    hESC derived from IVF for reproductive purposes
    Available alternative uses explained
    No payments for embryos
    Care provided independent of decision
    Should avoid clinician/researcher same
    Donors gave voluntary written consent to use embryos for research
  • 15. NIH, Informed Consent, and hESCs
    Must provide information on:
    Fate of embryos
    Embryos may be kept for years
    Research not intended as treatment for donor
    What personal, potentially identifying information would be available to researchers
    That research might result in financial gain for researchers, not donors
  • 16. Non-maleficence and The Moral Status of the Embryo
  • 17. When Does Life Begin?:Biological Landmarks
    Day 1 Fertilization
    Day 4-5 Cells used for hESC
    Day 7-10 Implantation
    Day 14 Primitive streak
    Weeks 18-20 Quickening
    Month 9 Delivery
  • 18. The Moral Status of the Embryo:When is the early embryo fully human?
    Aristotle and Aquinas: ensoulment with quickening
    Catholic Church through 1591 – abortion before quickening not punishable
    1869 - Pius IX - Excommunication for abortion at any stage of pregnancy
    Multiple ethics panels concluded the embryo is a developing human deserving respect but not full rights and protections
  • 19. Faith and Embryonic Stem Cell Research
    Harris Poll 2005
    70% Americans favor, 19% oppose
    70% Catholics, 38% born-again Evangelicals favor
    57% who oppose abortion favor embryonic stem cell research – “not in womb, not abortion”
    O. Hatch – opposes abortion, favors hESC research
    Islam - no prohibition
    Judaism – no prohibition
    Hindus – unclear
    MUSM research – IVF acceptable across faiths
  • 20. Embryos and the Law
    Georgia Criminal Law: “unborn child” means a member of the species homo sapiens at any stage of development who is carried in the womb.
    Roe v. Wade: "We need not resolve the difficult question of when life begins. When those trained in the respective disciplines of medicine, philosophy, and theology are unable to arrive at any consensus, the judiciary, at this point in the development of man's knowledge, is not in a position to speculate as to the answer.“ May abort up to time of fetal “viability”
  • 21. Ethics, IVF, and Stem Cells
    Does use of hESCs from IVF for procreation restrict research on cells from the poor?
    Is it morally acceptable to use existing stem cell lines created from embryos?
    Should gamete donors and potential parents have equal rights?
    Who should determine fate?
    Should Federal funds be used to derive new hESC lines for research?
  • 22. What to do with leftover embryos?
    Over 500,000 embryos in storage
    $100-150/year
    What if donors don’t pay for storage?
  • 23. Access to Stem Cell Benefits
  • 24. Stem Cell Fraud, Scams and non-FDA Approved Treatments
    Cloned human
    Offshore clinics
    Non-FDA approved
  • 25. Resources
    Elliott_rl@mercer.edu
    This presentation
    Medicine.mercer.edu – search medical ethics
    “resources”
    NIH resources on stem cell ethics
    http://bioethics.od.nih.gov/stemcell.html
    International Society for Stem Cell Research
    http://www.isscr.org/public/ethics.htm
  • 26.
  • 27. Supplemental Slides for Dr. Elliott
  • 28. More Complete Timeline
    1974 Congress bans all federally funded fetal tissue research
    Ethics Advisory Board established to set guidelines for research on fetal tissue research on tissue derived from abortions. EAB recommends federally funded research into IVF
    1981 EAB disbanded, effectively ends federal funding into research on embryonic stem cells
    DHHS continues moratorium on federal funding despite 18-3 recommendation for federal funding by b Human Fetal Tissue Transplantation Research Panel
    1993 Moratorium on federal funding lifted
    1994 Moratorium reinstated
  • 29. Preimplantation Genetic Testing
    Sex selection
    Genetic “defects”
    Physical characteristics
  • 30. Stem Cells and PEDs
    Should results from stem cell research be used to enhance performance?
    Human Growth hormone
    Anabolic steroids
    EPO
  • 31. IVF, RU486, IUDs
    RU486 as an emergency contraceptive and IUDs prevent implantation
    Contraception vs abortion in preventing implantation
    Compare unused (non-implanted) embryos from IVF with RU486 and IUDs ethically
  • 32. Terminology
    IVF
    Embryonic stem cells
    Totipotency, pluripotency
    Cloning
  • 33.
  • 34. Cloning
  • 35. Somatic Cell Nuclear transfer
  • 36. Somatic Cell Nuclear Transfer
    Generate stem cells with defective gene for research on disease, e.g., Parkinson’s
    Use patient’s cells to generate stem cells to create tissue for transplantation that has similar immunological characteristics as patient
    Hybrids
    Human cloning
  • 37. Induced Pluripotent Stem cells
  • 38.
  • 39. What are areas of ethical concern?
    Source and fate of stem cells
    Potential therapeutic uses and abuses
    Access to results
    Ethics and IVF
    Preimplantation Genetic Determination
    IVF, RU486, IUDs
    Cloning
  • 40. NIH Guidelines for Stem Cell Lines
    Pre-2009 18 hESC lines approved for study using federal funding
    2010 43 approved hESC lines, 115 submitted for review. But only one line from pre-2009 lines approved thus far