Individual Interests and Societal Concerns--The Ethics of Creating a Stem Cell Donor

1. Individual Interests and Societal Concerns--The Ethics of Creating a Stem Cell Donor Jeffrey Kahn, PhD, MPH Maas Family Chair in Bioethics Director and Professor Center for Bioethics University of Minnesota

2. Cellular Therapy for Fanconi Anemia • Recessive genetic disease • 2 carriers (heterozygous) mate, offspring: • ¼ = unaffected • ½ = carrier (no disease) • ¼ = affected (disease) • affected children • dysmorphologies • mildly reduced IQ • leukemia by 6-7 years old • require hematopoetic stem cell transplant to survive • bone marrow or umbilical cord blood • stem cell donors must be HLA (Human Lymphocyte Antigen) matched • sibs, other family, pools of adult donors, cord blood banks

4. Nash case background • Molly (6 yo) affected by Fanconi Anemia (FA) • Nashes hope to have more (unaffected) children • Consider natural conception followed by prenatal testing; then learn of PGD • Seek IVF in Denver, and PGD in Chicago • 2 stage PGD: FA -; HLA matched to Molly • 5 cycles to get 1 matched embryo • Adam born early August 2000 (Denver) • Cord blood flown to Univ. of Minn; stem cell transplant late Sept. 2000 + 100 days • Molly and family return to Denver Jan. 2001

6. Why does this case matter? • Application of biotechnologies that challenges our sense of what is ethically acceptable • Real case, real people • Serves as an object lesson for why we need to think about controls • A window onto future stem cell technologies • If we can find principles, rules, frameworks, it will help for other controversial policy areas • Points to the need for transnational approaches

7. Do characteristics chosen matter? • Selection vs. manipulation (testing vs. gene therapy) • To avoid disease • To select non-disease traits • Physical or behavioral characteristics • limited only by availability of genetic tests • HLA compatibility • but that’s a trait selected for benefit of someone other than the child • Ethics suggestion #1 • Require best interests of the child • but is that too low a standard?

8. Does motivation matter? • Why do people have children? • intrinsic value • carry on legacy • siblings for other children • by accident • tax deduction • more hands to work • are there wrong reasons? • and is saving a sick child’s life a bad reason?

9. Ethics and gaps in oversight • PGD, use cord blood, put baby up for adoption • PGD, abortion at 14-16 weeks, harvest cells from tissue • Don’t bear a child for his/her parts • Should we assess parents’ motives? • Unprecedented in many countries’ social policy • Put limits on allowable risk to the donor? • What about BMT, solid organ donation? • Third party review, offsetting medical or psychological benefit to donor? • Leave parents to make decisions for their children • UMN Stem Cell Ethics Advisory Board, now ESCRO

10. Why so few limits in the US? • Embryo research ban • no federal dollars (byproduct of abortion debate in Reagan I—1981 to present) • private funding OK, but no required oversight • Very limited third-party payment • no assessment of appropriateness • Almost non-existent professional self-regulation • All the above ties into stem cell debate • Multiple sites of responsibility • Denver, Chicago, Minneapolis

11. Implications • If Nash case is acceptable, how to respect equitable access for others? • Expensive therapy ($20k/cycle); limited access • Ethics of rescue will create huge costs • Impetus to create large number of embryos • Disposition of spare embryos • Limits of the use of genetic testing by parents • Charges of “designing babies” • Selecting from a ‘genetic menu’ • Recent application of PGD to sex selection and selection of genetic “defects” • Procreative liberty vs. mere means uses • As technologies emerge, and merge, we need new approaches for accountability (and oversight)