Stem Cell Research: Ethics, Translations and Transmissions

1. Stem Cell Research: Ethics, Translations and Transmissions Northwestern University An NIH Center of Excellence in Stem Cell Research Center for Bioethics Science and Society Laurie Zoloth, Ph.D Northwestern University Feinberg School of Medicine, Center for Bioethics, Science and Society

2. Plan of talk • Ethical Issues in International Stem Cell Research • List of first, second and current ethical concerns • Why we must now focus on justice • Description of theories of justice • Description of historical solutions in resource allocation • Proposals for fairness • One Critical Note about Veracity as the basis for all theory (both in science and in philosophy) • Gratitude Northwestern University Feinberg School of Medicine, Center for Bioethics, Science and Society

3. The First Years of Human Stem Cell Research—a brief review of where we’ve been • Raised three sorts of questions in ethics: • Origins : the cells raised issues of moral status of embryo • Process: Donations of eggs and sperm needed raised issues of informed consent • Telos: Long term goals raised issues of the telos or good ends of the idea itself Northwestern University Feinberg School of Medicine, Center for Bioethics, Science and Society

4. The Next Questions concerned Somatic Cell Nuclear Transfer • Raises new issues—cloning • Violation of order considered natural or divine • Species and boundaries • Slippery slope concerns Northwestern University Feinberg School of Medicine, Center for Bioethics, Science and Society

5. Core arguments against basic research in human stem cells • Slopes are slippery and the future is thus dangerous • Can not use the bodies of others even for good • Money and the marketplace are inherently corrupting • Nature is both fixed and sacred • DNA is ipsity—once established destroying it amounts to killing • Suffering and finitide defines humanity • Women could face particular abuse Northwestern University Feinberg School of Medicine, Center for Bioethics, Science and Society

6. That the more we learn about this Northwestern University Feinberg School of Medicine, Center for Bioethics, Science and Society

7. The better able we are to relieve human suffering Northwestern University Feinberg School of Medicine, Center for Bioethics, Science and Society

8. What have we learned so far? • Some questions are not resolvable • Some are merely very difficult to resolve • Some have just not yet been resolved in a temporal sense. Northwestern University Feinberg School of Medicine, Center for Bioethics, Science and Society

9. But of all the lessons we learned one thing. • Do not lie • For if you lie about the facts • Or hype the results • Or hype the fear • Then real discourse cannot happen. Northwestern University Feinberg School of Medicine, Center for Bioethics, Science and Society

10. Koreagate: Not too early to tell • That lying has had a devastating effect on the process • That international co-operation is made more difficult • That the entire process of bioethics is at issue • That bioethics must make its own demands Northwestern University Feinberg School of Medicine, Center for Bioethics, Science and Society

11. What it Means to Have Duties As in Kantian Moral Imperatives As in Religious Commands

12. That is the key question. • Isn’t the problem the moral status of the human embryo? Northwestern University Feinberg School of Medicine, Center for Bioethics, Science and Society

13. No. Northwestern University Feinberg School of Medicine, Center for Bioethics, Science and Society

14. Stem cell science raises important ethical questions • Even if we cannot decide about moral status • Which we cannot: for it is not a scientific question in its present form and in the present world. Northwestern University Feinberg School of Medicine, Center for Bioethics, Science and Society

15. I. 3 interesting Questions in biology and in ethics • What does it mean to be human? • What does it mean to be free? • What must I do about the suffering of the other? Northwestern University Feinberg School of Medicine, Center for Bioethics, Science and Society

16. II. A Particular history • 1970s: ability to deconstruct process of human reproduction • idea that infertility is a disease with a treatment • Creation of a genuinely new entity: an unenabled human embryo • In a country with a long history of interest in moral status issues • And Asilomar, which encouraged bioethicists Northwestern University Feinberg School of Medicine, Center for Bioethics, Science and Society

17. What policymakers actually need to ask: • Are there reasons in principle why performing the basic research should be impermissible? • What contextual factors should be taken into account an do any of these prevent development and use of the research? • What purposes, techniques or applications would be permissible and under what circumstances? • What procedures, structures, involving what policies, should be used to decide on appropriate techniques and uses? Northwestern University Feinberg School of Medicine, Center for Bioethics, Science and Society

18. 171 Bills debated in first months of 2005 at the state level in the US • 15 on umbilical cord blood banking • 156 on committed (“adult”) cells, hES or cloning • 14 enacted into law • A “New Federalism” Northwestern University Feinberg School of Medicine, Center for Bioethics, Science and Society

19. Separation Compromise Emerges • Election of 2004 Stem Cell Policy, 2005 Northwestern University Feinberg School of Medicine, Center for Bioethics, Science and Society

20. Stem cells debate draws on classic tropes and borders debates • Borders of democracy-> moral status of the other • Borders of Nature-> Fixed? Tamed? Normative? • Borders of mortality and suffering, contingency • Danger -> slopes, precaution, dual use, mistakes • Justice-> access, fairness, money and markets • A synedoche for modernity—a trigger for fundamental return(s) Northwestern University Feinberg School of Medicine, Center for Bioethics, Science and Society

21. Issues Considered by National Academy of Sciences in the United States 1) Recruitment of donors of blastocysts, gametes, or somatic cells informed consent financial incentives conflicts of interest donor confidentiality risks associated with oocyte retrieval handling of genetic information arising from the research 2) Characterization and standardization of stem cells 3) Safe handling and storage of blastocysts and stem cell material 4) Conditions for transfer of such material among laboratories 5) Appropriate uses of hES cells in research or therapy 6) Limitations on the use of hES cells 7) Safeguards against misuse Guidelines for Human Embryonic Stem Cell Research Northwestern University Feinberg School of Medicine, Center for Bioethics, Science and Society

22. Use local IRBs • Use existing BABs • Create new oversight groupings at local level • Statewide boards • National oversight (raises other risks) Northwestern University Feinberg School of Medicine, Center for Bioethics, Science and Society

23. Knowles: • “By creating the California Institute for Regenerative Medicine (CIRM) as a central body to distribute these funds, and within it, the Independent Citizen's Oversight Committee (ICOC) as a governing body to evaluate who receives them, the state has effectively created its own National Institutes of Health. “ Northwestern University Feinberg School of Medicine, Center for Bioethics, Science and Society

24. The Real NIH is shaken by new forces • Hurricanes • Basic flattening before hurricanes • Aging population, risk of infectious disease • Private model, HSA, and entrepreneurialism Northwestern University Feinberg School of Medicine, Center for Bioethics, Science and Society

25. How to regulate? Despite the appearance of a regulatory vacuum • Protections in place include: • federal human-subject research protection • FDA protections • Health Insurance Portability and Accountability patient privacy rules. • RAC guidelines • Apply to any research supported in whole or in part by federal funds or at institutions that have pledged to follow federal regulations. • ASRM guidelines Northwestern University Feinberg School of Medicine, Center for Bioethics, Science and Society

26. New Phase Begins: Establishment of Banks for hES lines • Earlier Questions marked by contention • Largely issues of faith • Issues of significant disagreement with low likelihood of solution • Search for determinate answers for largely indeterminate problems (see Nature, Oct 16) Northwestern University Feinberg School of Medicine, Center for Bioethics, Science and Society

27. Moving from theory to praxis • Will create immediate justice issues • Need for a UNOS or lottery system Northwestern University Feinberg School of Medicine, Center for Bioethics, Science and Society

28. Justice is prior to freedom • Levinas’s claim • Need I mention once again that truth is a prerequisite to justice Northwestern University Feinberg School of Medicine, Center for Bioethics, Science and Society

29. The Question of Justice • How does a society decide what is just? • In a world of scarcity, how ought a society justly distribute scarce goods and services? • In light of the particular and poignant crisis of health care what would be the language of such choices, • How can state can be accountable for justice • How can an international community reflect on justice? Northwestern University Feinberg School of Medicine, Center for Bioethics, Science and Society

30. Statement of problem • How can we set in place a fair and just system of access to the good ends of medicine? • Using a fair and just process that protects donors and recipients? • And aiming for fair and just goals for humanity? Northwestern University Feinberg School of Medicine, Center for Bioethics, Science and Society

31. Standard candidates for material principles of distribution • numerical equality • need • individual effort • social contribution • merit or desert Northwestern University Feinberg School of Medicine, Center for Bioethics, Science and Society

32. Theories come from material principles • Different theories of justice placed different emphasis on these material principles, • Can accept combinations of material principles • Understanding a particular theory of justice began by critically examining the theoretical justification of the selection of material principles Northwestern University Feinberg School of Medicine, Center for Bioethics, Science and Society

33. And from principles of liberal democracy • All liberal theories shared in common the presuppositions of the liberal tradition, • all rested on the assurance of the primacy of the individual the individual person, with liberty, rights, duties, and the ability to engage in voluntary consent, existed prior to the social contract itself. • the social contract that is entered into by rational free agents operating from an original position that was either historical or hypothetical, that created the liberal state Northwestern University Feinberg School of Medicine, Center for Bioethics, Science and Society

34. Libertarian theory • liberty, private property, and entitlement. • the problem of ownership • the rights of each individual to own his or her own resources. • According to the classic Lockean theory, the labor power of the individual, his actual work, was "mixed" with the natural resources, land, and water to create wealth that the individual then owned. • The ownership of the harvested crops was brought into being by virtue of the individual's creation of this commodity where none existed before. Northwestern University Feinberg School of Medicine, Center for Bioethics, Science and Society

35. Problems • Are free first holdings really free? • What of physical or genetic injustice? • Does the end not really not matter---could one accumulate nearly all the resources if done fairly? Northwestern University Feinberg School of Medicine, Center for Bioethics, Science and Society

36. Utilitarianism • “All action is for the sake of some end, and rules of action, it seems natural to suppose, must take their whole character and color from the end to which they are subservient. . . . When we are engaged in a pursuit, a clear and precise conception of what we are pursuing would seem to be the first thing we need, instead of the last we are to look forward to” • John Stuart Mill Northwestern University Feinberg School of Medicine, Center for Bioethics, Science and Society

37. Based in Consequences • Greatest happiness for greatest number • pleasure and the freedom from pain, are the only things desirable as ends; and that all desirable things (which are as numerous in the utilitarian as in any other schemes) are desirable either for the pleasure inherent in themselves, or as a means to the promotion of pleasure and the prevention of pain. Northwestern University Feinberg School of Medicine, Center for Bioethics, Science and Society

38. Not rights based • liberty was not a right unless it was justified by its utility to a society that was secure. • Claims of merit, claims of prior social contract, conflicting appeals, and material principles of justice were ultimately subjective and hence did not give a consistent account of justice. Northwestern University Feinberg School of Medicine, Center for Bioethics, Science and Society

39. Problems • Majority v minority • What is good? • Evil • Fate of individual Northwestern University Feinberg School of Medicine, Center for Bioethics, Science and Society

40. Deontology: Duties • There is a world of others to whom promises are made and to whom duties are owed. • And underlying norms and presumptions, • Duties create the means of being • In the context of relationships • With attendant obligations that guide our acts. • For some deontologists there were certain acts (truth telling, promise keeping) that contained moral worth distinct from their impact on consequences--independent of the net happiness, pleasure, or difficulties the fulfillment of the obligation would bring. Northwestern University Feinberg School of Medicine, Center for Bioethics, Science and Society

41. Kant • “nothing is left but the conformity of actions to universal law as such and this alone must serve the will as its principle. That is to say, I ought never to act except in such a way that I can also will that my maxim should become a universal law.” Northwestern University Feinberg School of Medicine, Center for Bioethics, Science and Society

42. Social Contract Theory • Based on equality of shares as in John Rawls • “Each person possesses an inviolability founded on justice that even the welfare of society as a whole cannot override. • justice denies that the loss of freedom for some is made right by a greater good shared by others. • Therefore in a just society the liberties of equal citizenship are taken as settled; the rights secured by justice are not subject to political bargaining or to the calculus of social interests.” Northwestern University Feinberg School of Medicine, Center for Bioethics, Science and Society

43. First Principle: Each person is to have an equal right to the most extensive total system of equal basic liberties compatible with a similar system of liberty for all Northwestern University Feinberg School of Medicine, Center for Bioethics, Science and Society

44. Second Principle: social and economic inequalities are to be arranged so that they are both: • a. to the greatest benefit of the least advantaged, • b. attached to positions open to all under conditions of fair equality of opportunity Northwestern University Feinberg School of Medicine, Center for Bioethics, Science and Society

45. Egalitarian Theories of Justice • each of us had inescapable and essential rights and obligations toward one another that could not be ignored • rights, obligations, duties, and needs arose from something we shared as persons, • common to all • must be respected by all. • commitment to equality • ability to make rational choices that honored this equality were at the heart of this theory of justice. Northwestern University Feinberg School of Medicine, Center for Bioethics, Science and Society

46. First among these duties was the notion that justice was rooted in equality, an equality due on the basis • of shared human embodiment and • participation in a mutually consensual human society. Northwestern University Feinberg School of Medicine, Center for Bioethics, Science and Society

47. A basic decent minimum. • This basic decent minimum was an assessment of a quantifiable human necessity • constituted the share to which all persons were entitled by virtue of their personhood alone • not because of merit or desert. Northwestern University Feinberg School of Medicine, Center for Bioethics, Science and Society

48. All these theories share these qualities: • Must be applicable: Any theory, to be ultimately credible, must address certain social imperatives: cultural norms, economic limits, and the power of the state. • Rooted in mortality and rooted in scarcity • Theory for rational beings Northwestern University Feinberg School of Medicine, Center for Bioethics, Science and Society

49. All faced challenges in the late 20th century • Feminist in North America • Liberation Theology in Latin America • Post- Modernist in Europe Northwestern University Feinberg School of Medicine, Center for Bioethics, Science and Society

50. But were the basis for many health care dilemmas • 3 Classic lifeboat problems in all technological advances • First use will be risky and dangerous • Will quickly be available to a small elite • Will move from desire to need to entitlement Northwestern University Feinberg School of Medicine, Center for Bioethics, Science and Society