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Ethics and Policy-Making in Stem Cell Research

Ethics and Policy-Making in Stem Cell Research. Presented by UC Berkeley’s STELA: The Science, Technology, Ethics, and Law Working Group. March 22, 2007. What is “ethics”?.

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Ethics and Policy-Making in Stem Cell Research

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  1. Ethics and Policy-Making in Stem Cell Research Presented by UC Berkeley’s STELA: The Science, Technology, Ethics, and Law Working Group March 22, 2007

  2. What is “ethics”? • Ethics: “the rules of conduct recognized in respect to a particular class of human actions or a particular group, culture”

  3. What is “Bioethics”? • Bioethics: “a field of study concerned with the ethics and philosophical implications of certain biological and medical procedures, technologies, and treatments, such as organ transplants, genetic engineering, and care of the terminally ill”

  4. A classic bioethical decision • One heart available  who should get it? • 70-year-old woman • 40-year-old school principal • 17-year old girl

  5. A classic bioethical decision • One heart available  who should get it? • 70-year-old woman • 40-year-old school principal • 17-year old girl

  6. Basic Bioethics Principles • RESPECT for people’s rights • Autonomy • Dignity • BENEFICENCE: Benefits must be proportionate to risks • Potential harm = potential good

  7. Basic Bioethics Principles • JUSTICE: The even distribution of benefits and risks throughout society • NONMALEFICENCE: Do no harm • Experiment must stop if causes harm.

  8. Decision-making organizations • Internal Review Boards (IRB’s) • President’s Council on Bioethics • 2001 • Independent Citizens’ Oversight Committee: • Part of California Institute for Regenerative Medicine (CIRM)

  9. Some recent stem cell policy… • President Bush: • August 2001: • moral risks > potential benefits • Federal funding can only be used for already made stem cell lines • “The life and death decision has already been made”- President Bush • The executive order applied only to federally-funded research • Did not ban new embryonic stem cell research all together • It may still be funded privately

  10. Some recent stem cell policy… • President’s Council on Bioethics • 2002 • “Human Cloning and Human Dignity” • Recommended policy of strict regulation of embryonic cloning • BUT, opinions varied

  11. Some recent stem cell policy… • California voters: • 2004, Prop 71 • Voted to spend $3 billion over the next ten years to fund stem cell research • PUBLIC money in the form of bonds

  12. Some recent stem cell policy… • U.S. House and Senate, July 2006 • Passed a bill to extend funding for research on NEW embryonic stem cell lines • In response, Bush VETOED • Moral integrity of the embryos • “Snowflake babies” campaign

  13. Who have been decision-makers? • Diverse stakeholders have influenced stem cell research policy • President Bush • President’s Council on Bioethics • Congress • California voters • Other possible stakeholders?

  14. Let’s start tackling some current ethical issues in stem cell research! • What we’re discussing next: • Use of leftover embryos from IVF clinics for embryonic stem cell research • What diseases will be researched? • You are the bioethicists!

  15. When stakeholders collide: Current IVF embryo policy • What is an IVF clinic? • Place where a couple can go after difficulty conceiving a child • Woman’s eggs extracted; man contributes sperm • Woman’s egg fertilized in-vitro • Outside her body • Embryos inserted into her uterus  pregnancy

  16. When stakeholders collide: Current IVF embryo policy • Left-over embryos • IVF procedure generates many embryos to increase chances of success • Usually get thrown out or frozen • BUT, stem cells can be derived from these!

  17. When stakeholders collide: Current IVF embryo policy • President Bush and others object • Potential for embryo “adoption” • June 2005: 80-100 ever adopted • Total: 400,000 • That is 0.02 – 0.025 % • Which is ethically “better”? • Throwing out an extra embryo, OR • Saving the embryo for adoption, OR • Using the embryo for biomedical research? • How do we find a compromise?

  18. The use of IVF embryos is not the only issue stem cell research is currently facing! • Some of the other questions policy-makers must tackle in the coming years: • How do we decide which diseases to do research on? • How do we make sure that all citizens receive equal access to the treatments, given that the research is funded with government (public) money?

  19. From stem cell research to therapies and cures • CA now has huge amount of funding available for stem cell research for therapies and cures • But which diseases in particular do we do stem cell research on? • How do we distribute the funding across the hundreds of diseases?

  20. Proposition 71 • The California Institute for Regenerative Medicine • What CIRM does: • Decides what research institutions get public money for stem cell research • Research must have the goal of curing or improving major diseases, injuries, and “orphan diseases” • Example: Tay-Sachs Disease

  21. What diseases do we do stem cell research on first? Muscular dystrophy likely to die by age 20 VS. Spinal cord injuries paralyzed, but likely to live longer

  22. What diseases do we do stem cell research on first? • Independent Citizen’s Oversight Committee (ICOC) includes: • Spinal cord injuries about 35,000 cases in CA • Alzheimer’s disease about 470,000 cases in CA • Type II (adult) diabetes 10% of adults (20 and up) have it • Multiple sclerosis in NorCal, 150 in 100,000 people have it • Type I (juvenile) diabetes 1 in every 400-600 children/adolescents • Heart disease #1 cause of death in US (12% of adults) • Cancer #2 cause of death in US (7.4% of adults) • Parkinson’s disease about 500,000 cases in US • Mental illness 22% of Americans have mental disorders • HIV/AIDS about 1 million cases of HIV in US • No “orphan diseases.”

  23. Common concerns in funding decisions • Number of people with the disease. • The groups that suffer from the disease. • Severity of the disease. • Disease mortality. • Average age at death. • Already available therapies or treatments.

  24. Activity: What diseases should we do research on? • Divide into small groups • Discuss the following, referring to the bioethics principles that we discussed yesterday and earlier: • Which concerns are most important? • Prioritize them, 1 through 6. COMPROMISE! • Some bonus questions: • Look back at the list of disease groups on the ICOC. Do the diseases on the list meet your criteria? Are there any diseases you think should be added to or removed from the list? • Are there any other criteria you think should be considered?

  25. For activity: ICOC diseases and bonus activity questions • Spinal cord injuries about 35,000 cases in CA • Alzheimer’s disease about 470,000 cases in CA • Type II (adult) diabetes 10% of adults (20 and up) have it • Multiple sclerosis in NorCal, 150 in 100,000 people have it • Type I (juvenile) diabetes 1 in every 400-600 children/adolescents • Heart disease #1 cause of death in US (12% of adults) • Cancer #2 cause of death in US (7.4% of adults) • Parkinson’s disease about 500,000 cases in US • Mental illness 22% of Americans have mental disorders • HIV/AIDS about 1 million cases of HIV in US • Look back at the list of disease groups on the ICOC. Do the diseases on the list meet your criteria? Are there any diseases you think should be added to or removed from the list? • Are there any other criteria you think should be considered?

  26. Take-home thoughts… • More ethical issues besides, “do we research on embryos?” • Today’s activity = what’s going on now in California • The future of bioethics needs: • Diverse group of both genders, all racial and ethnic groups, and from various backgrounds • Goal: Represent interests of all stakeholders

  27. Thank you!

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