Abdaal W Khan Consultant Transplant Surgeon, King Fahad National Guards Hospital, Riyadh. SA

1. Status of deceased donor Liver DonationIn Saudi Arabia – a Single Center Experience: a clinical and ethical perspective Abdaal W Khan Consultant Transplant Surgeon, King Fahad National Guards Hospital, Riyadh. SA

3. BACKGROUND • Saudi Arabia has an area of 2.2 m Km • Population is 22 million • 25 % expatriates

9. BACKGROUND • Islamic Ulema approved organ donation & transplantation: 1982 • National Kidney foundation: 1985 • Upgraded to SCOT : 1993

10. BACKGROUND • Well organized healthcare network • 116 ICU with 1500 beds • Brain Death protocol is strictly followed. • Coordinators also supervise the diagnosis and management of BD in all reported cases from medical and legal perspectives

11. BACKGROUND • Adult liver disease burden in Saudi Arabia: • Hepatitis B affects 1.2 Million • Hepatitis C affects 250,000 • (El Hamzi et al 2006) • Approx 400-500/year OLTx are needed in KSA

12. BACKGROUND • Active deceased donor programs for liver transplantation only fulfill 10%- 20% of the demand. • Consent rate around 30% • Donation rate 5/ million

13. BACKGROUND • Deceased donor liver transplantation started at KFH (and King Faisal) in 1994. • During this time, 207 deceased donor liver transplants were performed KFH.

14. BACKGROUND • Liver is particularly sensitive to • Hemo-dynamic instability • Electrolyte imbalances: high Na • Sepsis :– prolonged ICU stay • Many potential livers are declined due to poor quality.

15. METHODS • Data of deceased donor liver offers from SCOT to KFH were retrospectively analyzed from Jan 2003 to 15 Nov 2006. • Reasons for declining organ offers at the outset were assessed as well as • not transplanting a procured liver.

16. RESULTS • During this time, 168 livers were offered • There were 147 males and 21 females. • Age- Mean: 34.6 years, SD 11.6, range 1.5 to 60 • Nationality: • Saudis 19 • Expatriates 147 (87.5%), • Kuwaitis 2

17. RESULTS • Cause of Death: • MVA: 40.3% • CVA: 40.3% • Falls / head trauma: 7.5% • Anoxia: 4.5% • Brain Tumor: 1.5% • Not listed: 6%

18. RESULTS • The breakdown of donor offers by year • 29 for 2003, • 38 for 2004, • 47 for 2005 and • 54 until mid Nov. 2006. (65) • Of 168 offers, 90 livers (53.6%) declined outright for poor quality.

19. Livers not procured (n=90) • The main reasons singly or a combination • high LFT’s (x3), 30 donors • hypernatremia, 25 • hemodynamic instability 18 ( 5 with H/O cardiac arrest) • Sepsis 20 • Urgent request by KFSH & RC 8 • No recipient available: 3, these were then offered to KFSH & RC

20. Livers procured and not transplanted: 19/78 (24.3%) • The reasons were • Fatty Liver on biopsy: 15 (78.9%) • Fatty/unhealthy on gross examination: 1 • Active hepatitis in biopsy: 1 • Recipient unavailable: 1 • Liver offered to other center • Long Cold Ischemia Time: 1 • Weather delay in Kuwait

21. Transplants: 59 • Post-Operative Mortality : 4 (7%) • Mortality later : 14 m after txp • Re-transplants : 2, (1 died # 2 2nd Tx) • Overall mortality : 8.8% • The actuarial 1-year and 3-year survival was 91% and 83% respectively.

22. Conclusions: Clinical • Improper donor management is a major cause of rejecting potential livers without procurement. • The results of OLTx at KFH are at par with international standards.

23. Strategies to improve donation rates • Reporting of brain death: • Every brain death and every death be notified to SCOT • Education of ICU staff on BD and early reporting and donor management • Improving Consent rate: (30%) • NATIVES are still quite resistant – • Low literacy rate, education, religious leaders • Opt out: (Spanish Model):

24. ETHICAL PERSPECTIVE FINANCIAL INCENTIVES FOR CADAVERIC DONATION

25. BACKGROUND • Currently, are over 95,000 on the UNOS waiting list. • Consent rate around 45% (UNOS data) • Alternatives need to be explored • To prevent people dying on the WL • Limit people traveling to pay for a transplant in an illegal market.

26. Financial incentives • Incentive programs can be viewed as tools of persuasion • This does not mean that they are ALWAYS negative or they ALWAYS promote negative behaviors. • Nor should acceptance of incentives imply that activities associated with incentives are ALWAYS immoral or unethical ie

27. Financial Incentives • “If saving terminally ill patients is the ultimate goal in organ transplantation, there may be limited virtue in foreclosing compensation alternatives for cadaveric organ donations” ( Michelle Goodwin: Black market: The supply and demand in body parts. Page 211)

28. Financial incentives: the FEARS Does this destroy sanctity of human life? • No, the end result of organ donation is transplant (hopefully a successful one). • Recipient: Second chance at a healthy life

29. Financial incentives: the FEARS • Is this commodification of the body? • No, this could be viewed as recognition for an act of kindness • Healthcare workers are not less caring as a result of the pay check • The payment is for recognition for their work • Money does not turn everything to being evil…my pay check does not make me a bad person

30. Financial incentives: the FEARS • Family may withhold sensitive information which might contraindicate donation • Some families may not donate because financial considerations may cloud altruistic feelings

31. Paid Donation: FACTS • SCOT takes care of transportation of the donor to the village or city and pays currently $12,700 to the family of the deceased. • Only Saudi, (Kuwaiti & Qatar) nationals are eligible for organs harvested.

32. Paid donation: FACTS PROCESS IS WELL REGULATED: • Financial incentive is pre-set, and SCOT is legally, the only one allowed to be involved. • Recipient provides no financial contribution to the donors family nor is there any contact. • Transplant physicians/ surgeons are not involved in any part of the consent process. • ICU doctors are not paid for informing BD.

33. Paid donation: FACTS • NO LIFE INSURANCE FOR EMPLOYEES • Employers are not required by law to insure the employee against death. • This amount but may help support funeral costs and deceased family’s financial collapse

34. Principles of Bioethics • BENEFICENCE • NON-MALIFICENCE • AUTONOMY • JUSTICE

35. Beneficence • Always do good • Offering up organs to provide many a better chance at a healthy life is good • Providing for a family that has lost a breadwinner is good • More donors = more lives saved

36. Non-Malificence • No harm to the donor if a third party (government) rewards the family of the deceased with finances that can be put towards a funeral, debt repayment, charity (if the family chooses) • Recipient has no harm done to them if there is a financial transaction that does not involve him/her • Healthcare system has no harm done to it as a result of the financial savings, resulting from less dialysis treatments, less hospital admissions

37. Autonomy • Right to choice • Donors family still has a choice to provide consent • Decision may be affected by incentive offered as recognition • Though this is not different than all other decisions in life.

38. Justice JUST to provide a preset sum of money because • Transplantation saves health care money • Saves lives • Many people get a financial reward for their work in transplantation • The Donor initiates the transplant process (through consent) • Yet is the only altruistic person involved

39. Am Med Association • June 2003: “ AMA testified before US congress that shortage of organs was so critical that STUDIES need to be conducted on the effectiveness and outcomes associated with incentivised donations including possible financial incentives”

40. “ Any material scheme must have built into it safeguards against wrongful exploitation and show concern for the vulnerable as well as taking into account considerations of justice and equity.” (J Harris: BMJ 2006)

41. CONCLUSIONS: Ethical • Well regulated incentive based approach is ethically viable and may help in increasing consents for cadaveric organ donation. • Incentive based approach seems to work in Saudi Arabia & • Should be tested in other countries and cultures.

44. ??? Questions???

45. Living kidney donation • Recently the Government has allowed living non-related kidney donation by individuals. • This is attached with a gift of $12,500 which may also account for the reimbursement for expenses of travel, lodging and 6-8 weeks off work. • Restrictions: • The donor and recipient would remain confidential. • The donation is accepted between groups of same nationality only. • A team of professionals has been formulated to assess the psychological makeup, assess the motive for donation, and R/O coersion.

46. Living kidney donation– time will answer these • Will this deteriorate to husbands forcing their wives to donate for money? • Will this improve the quality of life of the donors family? • Will it be satisfying the altruistic streak in the donor? • Will rich stop going to poorer countries to get a kidney txp?