Wednesday, December 18, 2013

The sale of kidneys in Iran: a report from Shiraz

A recent article, and an accompanying editorial, in the American Journal of Transplantation concern the health of kidney sellers in Iran, based on a comparison of paid donors with unpaid related living donors at the Shiraz Transplant Center in Iran.

The article is Comparison of Health Status and Quality of Life of Related Versus Paid Unrelated Living Kidney Donors  by M. K. Fallahzadeh, L. Jafari, J. Roozbeh, N. Singh2, H. Shokouh-Amiri, S. Behzadi, G. A. Rais-Jalali1, M. Salehipour, S. A. Malekhosseini1, M. M. Sagheb

The aim of this cross-sectional study was to assess the health status and quality of life (QOL) of paid unrelated versus related living kidney donors postdonation at Shiraz Transplant Center in Iran. We invited all donors (n = 580, 347 paid unrelated, 233 related) who underwent donor nephrectomy at our center from 2004 to 2010 to participate in a health survey and physical examination. Of 580 donors, 144 consented to participate; participation of paid unrelated donors was significantly lower than related (52/347 vs. 92/233; p < 0.001). Participants underwent a complete physical examination, QOL assessment (using a 36-item short form health survey [SF-36] questionnaire) and laboratory work-up. The paid unrelated donors compared with related donors were younger (34.2 ± 7.2 vs. 40.7 ± 9.7 years, p < 0.001), had shorter time since donation (2.9 ± 1.6 vs. 3.8 ± 2 years, p = 0.004), had higher estimated GFR (72.6 ± 22 vs. 63.8 ± 15.3 mL/min/1.73 m2, p = 0.006) and had a higher percentage of patients with microalbuminuria (35% vs. 0%, p < 0.001). Additionally, general health and social functioning scores among paid unrelated donors were significantly lower (p < 0.001 and p = 0.02, respectively) than related donors. Other SF-36 scores, although lower in paid unrelated donors, did not reach statistical significance. Iranian paid unrelated donors have lower QOL and higher incidence of microalbuminuria compared with related donors.

In their concluding discussion the authors note
"To our knowledge, this is the first study comparing the health status and HRQOL of Iranian PUKDs with those of LRKDs. Our results show that Iranian PUKDs, compared with LRKDs, have poor follow-up, lower HRQOL scores and higher incidence of microalbuminuria.

One of the major drawbacks of the Iranian model of living donor kidney transplantation is the lack of long-term follow-up of LKDs [2, 3]. In our study, the rate of participation of PUKDs was significantly lower than LRKDs. Similarly, in a previous report from Iran, only 6 of 500 LKDs who were invited to participate in a health survey responded [2]. In another Iranian study, a majority (79%) of PUKDs were reported to have no regular follow-up after donation [6]. Inability to pay for follow-up visits, and insufficient knowledge of the complications of the nephrectomy and the need for regular follow-up postdonation have been suggested as the major reasons for lack of long-term follow-up among PUKDs [2, 6, 9]. Educating the LKDs, providing an extended long-term government sponsored medical insurance program beyond 1 year, and probably even payment for clinic visits could enhance their adherence with postdonation follow-up."

The accompanying editorial is Where There Is Smoke There Is Fire: The Iranian System of Paid Donation by E. J. Gordon, J. S. Gill

"Nearly 30 years after its introduction, the Iranian model remains an enigma to the Western transplant community. Established in 1988, the government-funded, compensated living unrelated kidney donor program was Iran's answer for its urgent transplantation needs. The modest fixed sum (currently about $400 US dollars) provided by the government was intended as a reward rather than as a payment for the donated kidney. The real incentive for those who have submitted to nephrectomy was a supplementary payment negotiated directly between the recipient and living donor (typically in the amount of $10 000 US dollars). Putative oversight by a not-for-profit organization maintains a buyer's market by providing a back-up donor in the event that a recipient and potential donor cannot agree on a price. The government pays for all transplant-related expenses and provides the donor with medical coverage for 1 year after the nephrectomy. It is worth noting that such depictions of the Iranian model have been contested as disingenuous by members of the Iranian transplant community [1]. Accordingly, one must interpret any analyses of the Iranian model with caution.

Predictably, critics of commercialization have opposed the program primarily out of concerns of exploitation and disrespect for human integrity [2, 3]. Aside from such opposition, the model fails to meet many of the proposed standards for a regulated system of organ sales, including nondirected donations, provisions to ensure long-term donor follow-up, and access to health care [4]. Despite the facilitation of tens of thousands of transplants, the lack of public reporting and transparency have precluded acceptance of the Iranian model as a solution to the organ shortage internationally, and have fueled questions about the integrity of the program.

The report by Fallahzadeh et al [5] in this issue of the journal provides a novel glimpse into the Iranian model. The study shares many of the limitations of other studies from Iran, including a small and selected study sample. However, their identification of a difference in microalbuminuria postnephrectomy between paid and unpaid donors fuels concerns that the clinical evaluation of donors may be compromised when donor payments are allowed. Although the absence of prenephrectomy information precludes definitive conclusions, the short time since donation suggests that abnormalities may have been present prior to nephrectomy and accordingly, that the donor clinical evaluation may not have been as thorough as necessary. The potential presence of predonation abnormalities is worth considering given the ethical ramifications. A scrupulous pretransplant evaluation and conservative approach to donor acceptance may be particularly important for paid donors who may be vulnerable to adverse health outcomes for other reasons. Subjecting paid donors to unnecessary harms without sufficient safeguards in place during the evaluation process tips the delicate risk–benefit balance against living donation.

The most plausible alternative explanation for the findings is that the proteinuria was in some way related to the higher level of poverty in the paid donors. There is limited research to suggest a link between poverty and development of proteinuria in living donors. In a cross-sectional study of living related donors from Hyderabad, India, 40% of the 50 donors studied developed microalbuminuria, and 14% developed overt proteinuria (>300 mg/day) after an average of 63 months postdonation [6]. Irrespective of the basis for the observed difference, it is not clear that the Iranian system will financially support the authors' recommendation for long-term follow-up of the individuals who developed microalbuminuria in the study.

Sadly, the risk factors for and clinical significance of proteinuria in living kidney donors remain unclear. The existing literature on this subject is hampered by use of nonstandardized definitions, a paucity of controlled studies, and virtually no information regarding progression over time. Therefore, although it is tempting to criticize the lack of organized donor follow-up in the Iranian model, to do so would be hypocritical [7]. The findings of this study therefore serve as a reminder of our collective responsibility to better understand the long-term consequences of living kidney donation.

The findings of Fallahzadeh et al [5] add to the accumulating literature that there are problems with the existing Iranian model and that the program must evolve. It is clear that the majority of paid donors are poor males, whose quality of life after nephrectomy is lower than that of the general Iranian population, and who are frequently dissatisfied with their decision to undergo nephrectomy [8]. Further, the program has been a contributing factor limiting the advancement of deceased donation and living related donation in Iran. For these reasons, a program that was once justified on the basis of need, may now be a barrier to the advancement of transplantation in Iran. How much harm to living donors' health and quality of life should Iranian transplant centers tolerate? As transplant centers are responsible for ethically sound clinical care, all potential living donors must be assured a high standard of clinical and psychosocial evaluation before the Iranian model can publicize its success.

As Fallahzadeh et al [5] point out, studies have found that few paid unrelated donors undergo follow-up care due to insufficient finances to pay for care, and donors lack knowledge about living donor complications or the need for follow-up care [9, 10]. Accordingly, transplant centers operating within the Iranian model should take extra care to optimally inform donors about the short- and long-term complications of living donation, as well as inform, encourage and enable living donors, particularly donors most at risk—paid unrelated donors—to undergo long-term follow-up care. The government's provision of health insurance to living donors for 1 year is a start toward removing some of the disincentives to donation; however, the recognition of paid donors as a particularly vulnerable group behooves the government to provide long-term follow-up care.

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