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
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
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
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?
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
First FDA-approved Clinical Trial Using hESCs January 2009 Geron Spinal cord injury
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
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
Non-maleficence and The Moral Status of the Embryo
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
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
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
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”
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?
What to do with leftover embryos? Over 500,000 embryos in storage $100-150/year What if donors don’t pay for storage?
Stem Cell Fraud, Scams and non-FDA Approved Treatments Cloned human Offshore clinics Non-FDA approved
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
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
Preimplantation Genetic Testing Sex selection Genetic “defects” Physical characteristics
Stem Cells and PEDs Should results from stem cell research be used to enhance performance? Human Growth hormone Anabolic steroids EPO
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
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
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
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