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Ethical Aspects of Iranian Model of LURD SM Gatmiri, MD, Nephrologist Assistant Professor of TUMS, NRC, Imam Khomeini hospital November 2012 In The Name.

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Presentation on theme: "Ethical Aspects of Iranian Model of LURD SM Gatmiri, MD, Nephrologist Assistant Professor of TUMS, NRC, Imam Khomeini hospital November 2012 In The Name."— Presentation transcript:

1 Ethical Aspects of Iranian Model of LURD SM Gatmiri, MD, Nephrologist Assistant Professor of TUMS, NRC, Imam Khomeini hospital November 2012 In The Name of God

2 Living unrelated renal donation (LURD) is a hot topic in organ shortage.

3 ESRD & Demand for RRT (HD, PD, LRD,LURD & BDD) is increasing

4 So LURD is in the core of medical caregivers’ attention. But controversial aspects of this entity, requiring ethical consideration.

5 And Transplantation societies and WHO try to prevent unethical practices in LURD.

6 The declaration of Istanbul (2008) is a global efforts to stop commercial exploitation in this field. 1 1

7 -Socioeconomic & cultural differences, -Religious beliefs, -Legislative barriers, and -Lack of infrastructure between countries, prevent setting standard international guidelines.

8 HISTORY OF RRT IN IRAN

9 Iran In 1974 (1353) First HD center >35 years ago.

10 Gradually, the number of patients on RRT increased from 587 in Tehran in 1991 to >25,000 (360 pmp) in 2006.

11 First kidney Tx 1967 (1346) But 112 renal Tx were performed until 1985.

12 In 1985 (1364) MOHME funded Renal Tx abroad (living related donor). 5, 6 56

13 At that time in 1985 (1364), two renal Tx centers were established and 274 renal Tx s were performed within 2 years.

14 In 1988 (1367) Council of Guardians regulated LURD program.

15 1988 (1367) LURD program was an outstanding achievement for patients with no access to dialysis and health authorities with limited budgets. 5, 7, 8 578

16 1995 (1374) Rejection of BDD in the parliament

17 1997 (1376) Board of Ministers approved Gift of Altruism. 7, 9 79

18 And Then Dramatic increase in Tx centers from - 2 in 1985 (1364) to -13 in (1371) and in 2001 (4) (1380)

19 1999 (1378) Disappearance of waiting list. 6, 7, 8 678

20 Shortly after the adoption of LURD program, MOHME adopted Same Natinality Donation.

21 2000 (1379) Legalizing brain- dead organ donation (BDD). 9 9

22 Different modalities of RRT [HD, PD, Tx ( LRD, LURD, BDD )] are free of charge.

23 Figure 1 | RRT trend in iran between 2001 and 2010.

24 THE PROCESS OF LURD

25 Figure 2 THE PROCESS OF LURD Only 18- to 35- year-old person

26 First Step Patients chooses LURD & potential donor will be referred to Patients’ Kidney Foundation(PKF).

27 Second Step Obtaining an informed consent from both donors and their next of kin.

28 3th step Potential donor and recipient are introduced to each other.

29 4 th step Refer to a nephrologist for final evaluation in detail.

30 Organ donation will be barred if borderline laboratory data has been seen.

31 Family pressure & coercion is considered when the potential donor is female.

32 At any time that potential donor like donation procss can stopped.

33 Male to female donor ratio=1.6:1 in >21,000 related and unrelated kidney Tx. 4 4

34 5 th step Negotiation between the donor and the recipient concerning an extra compensation for the donor.

35 PKF does not keep records of the agreed money for exchange.

36 PKF maintains some control on the issue by introducing another potential donor to the recipient if a donor asks for an unusual amount of money.

37 -There is no brokers And -Recipients and donors meet face to face.

38 6th step After Donation, donor refer to Charity Foundation for Special Diseases (CFSD) to get ‘gift of altruism’ and 1 year of medical insurance. 7, 13

39 Tx expense is paid by health insurance agencies and MOHME. 7

40 MEDICAL CONCERNS IN LURD

41 Short-term Risk Surgery Overall mortality risk in universe is 0.02–0.03%.

42 Major(1.5%) and Minor(8.5%) perioperative complications. 14

43 Kasiske found (0.05%) mortality at surgery.

44 0.03% risk of mortality found in surveys from UNOS- approved centers.

45 Segev 16 found surgical mortality of 3.1 per 10,000 in US.

46 Short-term complications in Iran are comparable to other international studies.

47 By laparoscopic nephrectomy, procedure became more safe with lower morbidities.

48 Long-term risks Risk of ESRD: 03–0.05% 17,

49 Survival of the donors: similar, if not superior, compared with general population. 15, 16, 17, 18

50 In the Ibrahim 17 study, 12.2±9.2 years after donation the prevalence of HTN was 32.1% and Microalbuminuria was 12.7%.

51 In Iranian donors in the only short-term follow up (17.2±5.0 months) HTN was 37.5% and Microalbuminuria was 10.4%. 19

52 ETHICAL ISSUE IN LURD

53 In the Iranian LURD several serious ethical problems have been successfully managed:

54 -No brokers, -No transplant tourism & commercialism -Same citizenship law -No financial benefit for Tx teams -Informed consent not only from recipients but also their next of kin. 5, 7, 9

55 ETHICAL CONCERNS IN LURD

56 Financial connection between donor and recipient

57 Main question of international experts Is not direct payment by the government and recipient to the donor defined as Vending?

58 Monetary compensation Once poor people are in the market to sell a kidney, such sales will be coercive even in the context of informed consent. 20,

59 Nobody denies that the most important motivation for donation in the Iranian model is not emotional/altruistic Nor does anyone deny that most of the donors belong to the low socioeconomic class. 22

60 But There are two points: -Autonomy, and -Socioeconomic situation of donors in comparison with recipients.

61 Autonomy -Poverty -Everybody has the right to overcome his/her problems by socially acceptable approaches.

62 In the Iranian LURD nobody interferes in the decision making of the poor donor to take a higher risk that the rich do not normally take.

63 Even Preventing this act may mean paternalism. 23, 24

64 Examples Higher ratio of lower socioeconomic groups in the -US military service -Mining. 25

65 Or -Firefighters and -Policemen who take high-risk jobs to protect others. 24

66 No Coercion In the Iranian LURD, donor is referred to the PKF by his/her own will. Obviously the economic situation influences such decision.

67 Bioethical principles -Autonomy -Beneficence -Justice, and -Nonmaleficence

68 Why should be all of the donor’s motivation only altruistic? 24

69 Socioeconomic situation of donors compared with recipients:

70

71 Financial motivation is the main driving force for donation. 26

72 Iranian donor situation is different with socioeconomic status of the vendors in Pakistan as an example of commercialism. 5, 22, 26, 28

73 90% of the vendors in Pakistan were illiterate (Iranian donors illiteracy rate is 94%). 5, 22, 26, 28

74 In iranian LURD, economic situations of the donor and recipient are not very different.

75 From 500 Iranian recipients 50.4% was poor (those who could not afford average housing, food, or college training for their children). 5

76 From 500 Iranian recipients 36.2% defined as the middle class. And Surprisingly just 13.4% were classified as wealthy. 5

77 Charity organizations and generous people support recipients. 5, 6, 7

78 Promotion of BDD by LURD In a study on 2630 HD patients, only 7% of medically eligible ones were registered on a BDD waiting list in Tehran province in 2005 (1384). 26, 31

79 Commercialism!!! Major financial source of organ trafficking in most developing countries is from recipients from developed countries. 23, 24

80 law of same citizenship in iran Blocked commercial organ Tx.

81 Direct method of payment Governmental or donor direct payment?! 5, 8 58

82 LURD as a realistic approache Many of countries evaluate expensive ways to increase organ resources, including: -Desensitization protocols for ABO incompatible & positive cross-match pairs, -Marginal donors, and -Organs from cardiac-dead donors.

83 Owing to the inadequate budget participation of recipients in direct compensation could not be prohibited.

84 BDD Bariers -Cultural barier -Medical barier (longer ischemic time &…).

85 Redirection of budget from LURD program to BDD program.

86 Multi-exchange-rate system 1750 rials/US dollar to 4000 rials/US dollar 7900 rials/US dollar In March rials/US dollar >30000 and rials/US dollar Now rials/US dollar.

87 It means that value of the governmental financial incentive for LURD decreased from >US$3500 in late 1990s to US$1265 in 2002 and to US$

88 Recommendation??? Rise in official governmental incentive and non-directed (altruistic anonymous) LURD without recipients compensation.

89 BDD program needs infrastructure and don’t exist in many developing countries.

90 Many surgery, urology residents, and nephrology fellows were trained in transplantation wards with LURD.

91 Transplantation as a routine instead of a complicated exceptional procedure.

92

93 Increase of BDD: - 2.2%, (0.4 pmp) in %, (7.9 pmp) in

94 BDD problems -Infrastructural deficiencies -Cultural barriers (73% refusal rate of BDD families)

95 Cultural obstacles are not easy to overcome.

96 Some believe that poor donors are generally underinformed and informed consent should be set aside

97 Donation process Decisions making Under pressure or Freely.

98 But Informed consent satisfy medical team that the donor (probably) is able to make a rational decision on the basis of his/her free will.

99 Even familial relationship does not guarantee the altruistic donation.

100 The informed consent from the next of kin of donor in the Iranian model is an attempt to make LURD the choice a consensus decision of the family.

101 Participation of a not-for- profit charity–based system in the process of getting the informed consent.

102 Is it appropriate to ban LURD?

103 So Current approach of many countries in response to shortage of organs is to encourage live donation.

104 So Ban of LURD would be unrealistic and unreasonable.

105 BDD cannot keep pace with the increasing number of ESRD patients.

106 LURD program had a great impact in development of infrastructure for BDD.

107 Ten years of experience with scientific, social, and public educational efforts made most people of the country familiar with the issue and decreased refusal rate of BDD.

108 Future Plan Move to presumed consents (assumed to have given their consent to organ donation unless they officially record their unwillingness during life) of all residents of the country.

109 By this law, coordinators can approach mourning families easier.

110 References Delmonico FL. The development of the declaration of Istanbul on organ trafficking and transplant tourism. Nephrol Dial Transplant 2008; 23: 3381– | Article | PubMed |ArticlePubMed The World Bank. Data: Iran, Islamic Rep. islamic-republic (updated 8 December 2011).http://data.worldbank.org/country/iran- islamic-republic Aghighi M, Heidary Rouchi A, Zamyadi M et al. Dialysis in Iran. Iran J Kidney Dis 2008; 2: 11–15. | PubMed |PubMed Mahdavi-Mazdeh M, Heidary Rouchi A, Norouzi S et al. Renal replacement therapy in Iran. Urol J 2007; 4: 66–70. | PubMed |PubMed Ghods AJ, Savaj S. Iranian model of paid and regulated living-unrelated kidney donation. Clin J Am Soc Nephrol 2006; 1: 1136–1145. | Article | PubMed |ArticlePubMed Einollahi B. Iranian experience with the non-related renal transplantation. Saudi J Kidney Dis Transpl 2004; 15: 421–428. | PubMed |PubMed Simforoosh N. Kidney donation and rewarded gifting: an Iranian model. Nat Clin Pract Urol 2007; 4: 292–293. | Article | PubMed |ArticlePubMed

111 Zahedi F, Fazel I, Larijani B. An overview of organ transplantation in Iran over three decades: with special focus on renal transplantation. Iranian J Publ Health 2009; 38: 138–149. Mahdavi-Mazdeh M, Rouchi AH, Rajolani H et al. Transplantation registry in Iran. Transplant Proc 2008; 40: 126–128. | Article | PubMed | Simforoosh N, Bassiri A, Amiransari B et al. Living-unrelated renal transplantation. Transplant Proc 1992; 24: 2421–2422. | PubMed | CAS | Simforoosh N, Basiri A, Tabibi A et al. Laparoscopic donor nephrectomy—an Iranian model for developing countries: a cost-effective no-rush approach. Exp Clin Transplant 2004; 2: 249–253. | PubMed | Nozary Heshmati B, Tavakoli SA, Mahdavi-Mazdeh M et al. Assessment of brain death of organ donors in Iran. Transpl Int 2010; 23: e7–e9. | Article | PubMed | Larijani B, Zahedi F, Taheri E. Ethical and legal aspects of organ transplantation in Iran. Transplant Proc 2004; 36: 1241–1244. | Article | PubMed | CAS | Ghods AJ. Ethical issues and living unrelated donor kidney transplantation. Iran J Kidney Dis 2009; 3: 183–191. | PubMed |

112 Kasiske BL, Ravenscraft M, Ramos EL et al. The evaluation of living renal transplant donors: clinical practice guidelines. Ad Hoc clinical practice guidelines subcommittee of the patient care and education committee of the American Society of Transplant Physicians. J Am Soc Nephrol 1996; 7: 2288– | PubMed | ISI | CAS | Segev DL, Muzaale AD, Caffo BS et al. Perioperative mortality and long-term survival following live kidney donation. JAMA 2010; 303: 959– 966. | Article | PubMed | ISI | CAS | Ibrahim HN, Foley R, Tan L et al. Long-term consequences of kidney donation. N Engl J Med 2009; 360: 459–469. | Article | PubMed | ISI | CAS | Fehrman-Ekholm I, Norden G, Lennerling A et al. Incidence of end-stage renal disease among live kidney donors. Transplantation 2006; 82: 1646– | Article | PubMed | Azar SA, Nakhjavani MR, Tarzamni MK et al. Is living kidney donation really safe? Transplant Proc 2007; 39: 822–823. | Article | PubMed |

113 Harmon W, Delmonico F. Payment for kidneys: a government- regulated system is not ethically achievable. Clin J Am Soc Nephrol 2006; 1: 1146–1147. | Article | PubMed | Hughes PM. Constraint, consent, and well-being in human kidney sales. J Med Philos 2009; 34: 606–631. | Article | PubMed | Malakoutian T, Hakemi MS, Nassiri AA et al. Socioeconomic status of Iranian living unrelated kidney donors: a multicenter study. Transplant Proc 2007; 39: 824–825. | Article | PubMed | Friedman EA, Friedman AL. Payment for donor kidneys: pros and cons. Kidney Int 2006; 69: 960–962. | Article | PubMed | CAS |

114 Matas AJ. Why we should develop a regulated system of kidney sales: a call for action!. Clin J Am Soc Nephrol 2006; 1: 1129– | Article | PubMed | Monaco AP. Rewards for organ donation: the time has come. Kidney Int 2006; 69: 955–957. | Article | PubMed | CAS | Heidary Rouchi A, Mahdavi-Mazdeh M, Zamyadi M. Compensated living kidney donation in Iran: donor's attitude and short-term follow-up. Iran J Kidney Dis 2009; 3: 34–39. | PubMed | Zargooshi J. Iranian kidney donors: motivations and relations with recipients. J Urol 2001; 165: 386– 392. | Article | PubMed | ISI | CAS | Naqvi SA, Ali B, Mazhar F et al. A socioeconomic survey of kidney vendors in Pakistan. Transpl Int 2007; 20:

115 934–939. | Article | PubMed | ISI | Rizvi SA, Naqvi SA, Zafar MN et al. A renal transplantation model for developing countries. Am J Transplant 2011; 11: 2302– | Article | PubMed | Rizvi SAH, Naqvi SAA, Hussain Z et al. Renal transplantation in developing countries. Kidney Int 2003; 63: S96–S100. | Article | Mahdavi-Mazdeh M, Zamyadi M, Nafar M. Assessment of management and treatment responses in haemodialysis patients from Tehran province, Iran. Nephrol Dial Transplant 2008; 23: 288–293. | Article | PubMed | Transplant Procurement Management IRODaT (updated 8 December 2011). Khoddami Vishteh H, Ghorbani F, Ghobadi O et al. Causes and follow-up outcomes of brain dead patients in Shahid Beheshti University of Medical Sciences hospitals. Pejouhandeh 2010; 15: 171–178. Teraoka S. Current status and issues of organ transplantation in Japan). Nippon Rinsho 2010; 68: 2173–2185. | PubMed |


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