Friday, September 11, 2020

Global Kidney Exchange supported by the European Society of Transplantation's committee on Ethical, Legal, and Psychosocial Aspects of Transplantation .

Quite some time ago, the European Society for Organ Transplantation (ESOT) charged its committee on Ethical, Legal, and Psychosocial Aspects of Transplantation (ELPAT) with the task of evaluating those aspects of global kidney exchange (GKE). GKE had been greeted in some quarters with a number of dramatic accusations (e.g. that it was a form of organ trafficking), and the ELPAT committee tried to consider each of them.  Interestingly, the committee included members who I surmise started with a wide range of views, from cautious support to active hostility to GKE.

The final report, just published in Transplant International,  (which is the official journal of ESOT) is one that I think the committee can be proud of.  While you can tell that some committee members retain reservations about GKE, they nevertheless all agreed on a report that finds all of the principal objections raised against GKE to be unfounded.  Together with the even more clearly stated support for GKE in the Lancet, I think that this may mark a turning point: it certainly marks that GKE is receiving growing (and well deserved) support. 

Global Kidney Exchange: opportunity or exploitation? An ELPAT/ESOT appraisal
Frederike Ambagtsheer  Bernadette Haase‐Kromwijk  Frank J. M. F. Dor  Greg Moorlock  Franco Citterio  Thierry Berney  Emma K. Massey
Transplant International, September 2020, 33, 9, 989-998.    
https://onlinelibrary.wiley.com/doi/full/10.1111/tri.13630       Here's the pdf

"Summary: This paper addresses ethical, legal, and psychosocial aspects of Global Kidney Exchange (GKE). Concerns have been raised that GKE violates the nonpayment principle, exploits donors in low‐ and middle‐income countries, and detracts from the aim of self‐sufficiency. We review the arguments for and against GKE. We argue that while some concerns about GKE are justified based on the available evidence, others are speculative and do not apply exclusively to GKE but to living donation more generally. We posit that concerns can be mitigated by implementing safeguards, by developing minimum quality criteria and by establishing an international committee that independently monitors and evaluates GKE’s procedures and outcomes. Several questions remain however that warrant further clarification. What are the experiences and views of recipients and donors participating in GKE? Who manages the escrow funds that have been put in place for donor and recipients? What procedures and safeguards have been put in place to prevent corruption of these funds? What are the inclusion criteria for participating GKE centers? GKE provides opportunity to promote access to donation and transplantation but can only be conducted with the appropriate safeguards. Patients’ and donors’ voices are missing in this debate." 

Here's their introduction:

"In 2017, Rees et al. [1] introduced “Global Kidney Exchange” (GKE), an international kidney exchange program that facilitates cross‐border exchanges between immunologically incompatible donor–recipient pairs in high‐income countries (HIC) and biologically compatible but financially impoverished donor–recipient pairs in low‐ to middle‐income countries (LMIC). GKE aims to overcome immunologic barriers in the developed world and poverty barriers in the developing world. The underlying rationale is that financial barriers prevent transplantation much more frequently than organ scarcity. The number of patients dying annually worldwide from end‐stage kidney disease due to inadequate financial resources far exceeds the number of patients in developed countries placed on kidney transplantation waitlists [1-3]. GKE has the potential to expand the genetic diversity of the donor pool which may help to transplant difficult‐to‐transplant, highly immunized patients [1]."

As they debunk the main arguments that have been made against GKE, I thought that some of these remarks were among the most interesting:

"Removing financial barriers to organ donation is an internationally agreed objective, enshrined, among others, in the World Health Organization’s (WHO) Guiding Principles on Human Cell, Tissue and Organ Transplantation and in the CoE Convention [13, 15]. These organizations highlight that prohibition of organ payments does not preclude reimbursing expenses incurred by the donor, including the costs of medical procedures [13, 17]. Given that countries’ legislation vary in their approach to what constitutes illicit payment versus legitimate reimbursement, it is doubtful whether GKE violates the nonpayment principle under all circumstances. For example, the University of Minnesota’s legal team vetted GKE and agreed to proceed. Other hospital legal teams have followed suit [1]."
...

"“[e]xploitation occurs when someone takes advantage of a vulnerability in another person for their own benefit, creating a disparity in the benefits gained by the two parties” [9]. It is hard to see, however, that this description of exploitation can be readily applied to GKE. Primarily, it is not clear that there is a significant disparity in benefits between recipients. Each patient receives a kidney transplant, and as Minerva et al point out, benefits are arguably greater for LMIC recipients, who get the additional benefit of their follow‐up care being paid for [33]. The same is true for the donors, who each obtain the desired benefit of their intended beneficiary receiving a transplant. Rather than there being a morally troubling disparity in benefit, GKE appears to offer either roughly equal benefit, or greater benefit for those who are allegedly exploited."
"It is also unconvincing to consider GKE exploitative on other grounds. Rather than failing to protect the vulnerable, it seems that GKE addresses specific vulnerabilities by offering protection to those who are (i) vulnerable to death from kidney failure or (ii) vulnerable to losing a loved one due to kidney failure. It is similarly unconvincing to suggest that GKE treats people merely as a means to an end. Instead, one can see that participants in LMIC are respected as individuals, with measures put in place to protect their welfare and to ensure that their participation is voluntary."
...
The claim that donors and recipients in LMIC are too poor or vulnerable to voluntarily engage in GKE is also debatable and could be seen as paternalistic. First of all, the risk that voluntariness is undermined does not apply specifically to GKE or to LMIC alone, but applies to living donation more generally [35].
...
"The proclamation that countries have to be self‐sufficient was first declared by the 2008 DoI and the WHO [73, 74] and has rapidly gained momentum since [75-77]. The argument to ban GKE because of the need to achieve self‐sufficiency raises various implications however. First of all, it implies that the need for countries to become self‐sufficient is more important than the lives that can be immediately saved through GKE. Is achievement of self‐sufficiency so important that it overrides life‐saving alternatives? Who has the authority to decide which approach should get priority? Why is it required that countries become self‐sufficient in organ donation and transplantation, while it is universally accepted for countries to rely on global exchanges of all other types of goods and services?
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The ESOT/ELPAT committee apparently operated under rules that prevented them from investigating some claims that required evidence, so they included some questions for us in their paper, which we answer in the comment that appeared in the same issue of TI. (For example, there was some confusion about what escrow meant in connection with the money provided for the foreign donor and recipient's medical expenses after their return home...)

In any event, the large number of co-authors to our comment (21!) is another expression of the broad and international support that GKE is achieving.

Global Kidney Exchange Should Expand Wisely
Alvin E. Roth  Ignazio R. Marino  Obi Ekwenna  Ty B. Dunn  Siegfredo R. Paloyo  Miguel Tan  Ricardo Correa‐Rotter  Christian S. Kuhr  Christopher L. Marsh  Jorge Ortiz  Giuliano Testa  Puneet Sindhwani  Dorry L. Segev  Jeffrey Rogers  Jeffrey D. Punch  Rachel C. Forbes  Michael A. Zimmerman  Matthew J. Ellis  Aparna Rege  Laura Basagoitia  Kimberly D. Krawiec  Michael A. Rees 
Transplant International, September 2020, 33, 9,  985-988. https://onlinelibrary.wiley.com/doi/full/10.1111/tri.13656   Here's a link to the pdf 

Here's the full first paragraph:

"We read with great interest and appreciation the careful consideration and analysis by Ambagtsheer et al. of the most critical ethical objections to Global Kidney Exchange (GKE). Ambagtsheer et al. conclude that implementation of GKE is a means to increase access to transplantation ethically and effectively.1,2 These conclusions by their European Society of Transplantation (ESOT) committee on Ethical, Legal and Psychological Aspects of Transplantation (ELPAT) represent a step forward toward a greater understanding and an open, honest debate about GKE. Taken together with the strong endorsement of GKE by Minerva et al. in Lancet  and the positive position statement of the American Society of Transplant Surgeons (ASTS), Ambagtsheer et al. successfully dispel previously raised doubts 5-13 to which we have previously responded .2,14-17"
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