Ethical Considerations of Umbilical Cord Blood Banking

1. Ethical Considerations of Umbilical Cord Blood Banking Jeff Nisker MD PhD FRCSC OGOPEER Rounds Sept. 5th, 2006

2. What is Justice in Healthcare? • Distributive justice • Rawls’ two principles of justice 1. Each person has an equal claim to a fully adequate scheme of rights and liberties compatible with the same scheme for all 2. Under conditions of fair equality of opportunity - the greatest benefit of the least advantaged members of society. • Rawls’ A Theory of Justice 1971 - veil of ignorance • Bourgeois - anamnestic agent

3. Transparency Declaration • rich/poor same (unless surplus of physicians and funding?) • favour public banks • justice articles Rachel’s ladders Hum Reproduction 1997 Quixotic quest Women’s Health Issues 1997 Child on Her Mind 2000 Chalcedones Cdian Med Assoc J 2001 Sarah’s Daughters 2001 A brief and shining moment J Obstet Gynec Cda 2003 Anniversary of injustice J Obstet Gynec Cda 2004 In our hands J Obstet Gynec Cda 2004 Report to court re Quebec challenge 2006

4. Ethical Issues in UCB Banking • Informed choice • Only “good” (or best) medicine is moral medicine • Registries: privacy and confidentiality • Justice (fairness) • Unethical commercial practices

5. Background • 1970 16-yr-old boy ALL received untested UCB from eight unrelated donors and in remission at last followup (9 months) (Ende 1972) • 1988 5-yr-old boy “cured” of Fanconi anemia after receiving blood from baby sister (Gluckman et al 1989) • 1992 New York plancental blood program • 1996 public UCB banks in New York, Milan, Dusseldorf, UK and Alberta • 33 cord-blood registries in 21 countries on Bone Marrow Donors’ worldwide website

6. SOGC Clinical Practice Guidelines Umbilical Cord Blood Banking: Implications for Perinatal Care Providers No 156, March 2005 Principal Author B. Anthony Armson, MD, FRCSC, Halifax NS Maternal/Fetal Medicine Committee Jon Crane (Chair), MD, FRCSC, ST John’s NL

7. 1) Informed Choice in UCB Banking Linda Karaboyan, Bartha M. Knoppers, Denise Avard, Jeff Nisker Women’s Health Issues 2006

8. Informed Choice in UCB Banking a) Sources of information - internet and magazine advertisements caution women that storing UCB “once in a lifetime opportunity” and “worthwhile investment” that can save their child. - obstetrical care providers - FPs, nurses, midwives, obstetricians, prenatal class educators - family members b) When - well in advance of birth

9. Informed Choice in UCB Banking c) Choices - discard - donate to research - store in private bank - store in public bank

10. Informed Choice in UCB Banking d) What - promising potential and current indications for their collection, storage and use (Armson, SOGC, 2005) - UCB will not help treat genetic condition if it contains the genetic instruction causing the disease (Fisk, Roberts, Markwald, & Mironov, 2005) - private vs public banks: - cannot reserve units in public bank for private use - if transplantation need arises for child, unlikely that UCB remains - privacy and confidentiality concerns - alternative uses of donated or banked samples - difficult to make decisions based on promise of future scientific advancement

11. Informed Choice in UCB Banking e) Reveal information about paternity, infectious diseases and susceptibility to genetic disease - must inform about which infectious agents being tested for and how they will be informed - testing newborns for adult onset conditions can have psychological implications and potentially put children at risk of suffering insurance, education and employment-related discrimination

12. Informed Choice in UCB Banking f) Consent for research - more than half of UCB inappropriate for transplantation (Gunning, 2004) - stem cells scientists have requested access (American Society of Human Genetics, 2001) - potential commercial applications of the research needs to be disclosed as part of informed choice process (National Consultative Ethics Committee for Health and Life Sciences, 2002; European Group on Ethics in Science and New Technologies, 2004) g) Do care providers have an obligation to bring up UCB banking? (Ellen Rosen VP LHSC 2006)

13. Informed Choice in UCB Banking SOGC Guideline Rec 1: Perinatal care providers should be informed about the promising clinical potential of hematopoietic stem cells in umbilical cord blood and about current indications for its collection, storage, and use, based on sound scientific evidence (II-3B) SOCG Guideline Rec 12: Recruitment of cord blood donors should be fair and noncoercive. Criteria to ensure an equitable recruitment process include the following: (a) adequate supply to meet population transplantation needs; (b) fair distribution of the burdens and benefits of cord blood collection; (c) optimal timing of recruitment; (d) appropriately trained personnel; and (e) accurate recruitment message (III-A) SOCG Guideline Rec 13: Informed consent for umbilical cord blood collection and banking should be obtained during prenatal care, before the onset of labour, with confirmation of consent after delivery (III-B)

14. 2) Only “good” medicine is moral medicine SOGC Guideline Rec 8: The safe management of obstetric delivery should never be compromised to facilitate cord blood collection. Monoeuvres to optimize cord blood unit volume, such as early clamping of the umbilical cord, may be employed at the discretion of the perinatal care team, provided the safety of the mother and newborn remains the major priority (III-A)

15. 3) Registries and Linked Records: Privacy and Confidentiality - allow donors and recipients to be found, informed and referred for care if infectious or genetic diseases are detected after UCB stem cells have been transplanted (McCullough et al., 1994) - allow trace of donated UCB if child requires autologous transplant - should new genetic tests become available - allow researchers to re-contact donors (who have previously consented) and obtain informed consent to conduct testing on their materials, thus giving them possibility of benefiting from early diagnosis and treatment (Pinch, 2001)

16. Justice (Fairness ) • Public banks - stem cells available to those in most need • Most professional organizations indicate that autologous banking is unwarranted - child needing bone marrow transplant between 1:200,000 and 1:10,000 - American College of Obstetricians and Gynecologists - American Academy of Pediatrics - Royal College of Obstetricians and Gynaecologists (UK) - Society of Obstetricians and Gynaecologists of Canada

17. Cost in 6 private UCB banks in Canada approx $900 initially and $150/yr (Armson - SOGC 2005) • Alberta cord blood bank has limited funding through Tanya Smale Cord Blood Foundation - as received only $5000 cord blood, $1000 units HLA-typed, 4 units transplants (Armson - SOGC 2005)

18. Lessons from IVF April Fool’s Day 1994 IVF de-listed (except bilateral blocked tubes) • University Hospital (LHSC) 2nd-largest IVF unit in world (A. Yuzpe) • commercial IVF begins in Ontario • egg bartering begins • women from southwestern Ontario go to Toronto to barter their oocytes

19. SOGC Guideline Rec 5: Altruistic donation of cord blood for public banking and subsequent allogeneic transplantation should be encouraged when umbilical cord banking is being considered by child bearing women, prenatal care providers, and (or) obstetric facilities (II-2B) SOGC Guideline Rec 11: Canada should establish registration, regulation, and accreditation of cord blood collection centres and banks (III-B)

20. 5) Unethical Commercial Practices • private companies reported to recruit women donors by representing themselves as public banks (Saginur, Kharaboyan & Knoppers, 2005) • private UCB banks reported to store cord blood gratuitously but can sell compatible matches to patients in urgent need of transplantation or research companies for $15,000 per unit ( pay obstetricians finder’s fee for collecting cord blood from their patients) (Hundley, 2003) • obstetricians must disclose personal commercial interests as well as those of the company that stores UCB (FIGO 2003)