Thursday, February 28, 2013

Compensation for kidney donors: once again under discussion

The American Journal of Transplantation published the following article, by a large group of authors called the Working Group on Incentives for Living Donation:
"Incentives for Organ Donation: Proposed Standards for an Internationally Acceptable System"
Volume 12, Issue 2, pages 306–312, February 2012

Some idea of the content of their recommendations can be gotten from the following Table:
Table 2.  Guidelines for development of a regulated system of incentives for deceased and living donation
(1) Each country implementing a system of incentives should have a legal and regulatory framework for the process.
(2) The entire process must be transparent and subject to government and international oversight.
(3) The incentive should be provided by the state or state-recognized third party. Under well-defined, transparent and regulated circumstances, prospective recipients may help fund a charity that supports the program. There is no direct payment from the recipient to the donor and supporting the charity will not result in advancement on the waiting list.
(4) Allocation of the organ(s) should be performed according to the single recognized system of that country (similar to UNOS in the United States) using a predefined and transparent algorithm so that everyone on the list has an opportunity to be transplanted. Kidneys would be allocated to the number 1 person on the list (as determined by defined and transparent criteria).
(5) There should be a plan for administration and for rigorous oversight to ensure that criteria for evaluation, acceptance, allocation and provision of the incentive to the donor (or donor family) are being followed.
(6) The donation should be anonymous and nondirected.
(7) No other solid organ donor incentive plan would be legal.
(8) There should be legislation to govern wrongdoing and how centers would be censured, including criminal sanctions and fines, if wrongdoing is identified.

The  article drew the following replies in the Letters to the Editor
F. Delmonico, G. Danovitch, A. Capron, A. Levin and J. Chapman, Council, Declaration of Istanbul Custodian Group, Montreal, QUE, Canada
B. Padilla, D. Bayog, N. L. Uy, I. Gueco, L. Nazareno-Rosales, A. Chua, L. Almazan-Gomez, D. Bonzon, B. Balmores and E. Cabral
"The report on the proposed “international standards” for financial incentives for organ donation in the February issue of the AJT (1), stated that “until there are trials, we have no means of knowing under precisely what circumstances such a proposal would best succeed”. Permit us to report that a regulated system of incentives for living organ donors was already implemented in the Philippines from 2002 to 2008. The program offered a sizable “gratuity package” while mandating systems and procedures for transparency, creation of ethical guidelines, monitoring of transplant facilities and a donor registry, much like what this article proposes. The reality was different from the intended outcomes. The black market was not eliminated and organ brokers continued to be involved (Roberto Tanchanco et al., unpublished cohort study, 2011) (2). A regulation that transplants to foreigners should comprise no more than 10% of total transplants proved unenforceable and transplant tourism flourished (3). Donors were not protected, as there was failure of informed consent, lack of economic improvement in the donors’ lives and poor rate of medical follow-up (Roberto Tanchanco et al., unpublished cohort study, 2011) (2). A study limited to the donors within the government-regulated program reported better economic outcomes, but this was hardly convincing as poor follow-up allowed reporting of data in only 81 of 164 participants (Romina Danguilan et al., unpublished cross-sectional study, 2010).

Thus, our experience leads us to believe that the Matas article underestimates the problems related to the approach they recommend. A system of incentives for living unrelated donors which is difficult to differentiate from a disguised organ market is totally inappropriate for a country like the Philippines, where many patients have a potential related donor but cannot afford to pay for a transplant, where the deceased donor program is still very infantile, where the poor have been exploited in organ trafficking before and a large sector of the population remains vulnerable."

A Realistic Proposal—Incentives MayIncrease Donation—We Need Trials Now!
A. Matas, J.A.E. Ambagtsheer, R. Gaston, T. Gutmann, B. Hippen, S. Munn, E. T. Ona, J. Radcliffe-Richards, A. Reed, S. Satel, W. Weimar and R. Danguilan

"To the Editor:
The shortage of organs is a critical problem for patients with organ failure, and has led to a polarizing discussion. Some, including us, have suggested that a regulated system of incentives might increase donation and alleviate the crisis (1,2). Others, championed by Chapman, Danovitch, Padilla and Delmonico, have passionately opposed this option (3–6).
Delmonico et al., representing the Declaration of Istanbul [DoI] Custodial Group (DICG) now write that our proposed guidelines for a regulated system are not acceptable (4). Our proposal, as stated in the manuscript, was presented as a basis for discussion (7). Rather than suggesting modifications or improvements, the DICG simply condemns it.
Their condemnation rests on two arguments. First, that others have suggested that “sales,”“brokering” and “organ markets” are wrong, and that we have “departed from the consensus.” Yet we clearly state our opposition to exploitation and unregulated markets, and instead suggest a government-regulated system with explicit limits to prevent the abuses all parties decry. But even the supposition that we have no right to challenge “the consensus” is suspect. When, in moral debate, is majority opinion the final argument? If it were, homosexuals would still be criminals and women still subordinate to their husbands and excluded from public life–both once widely held majority views enshrined by law.
And where does this so-called consensus come from? The DICG refers to the World Health Organization (WHO) and the DoI. Yet, the WHO has updated its Guiding Principles (most recently supporting reimbursement of costs and of emotionally or legally related donors vs. previous stance banning all but genetically related donors and any payment). The draft of the DoI was written by a Steering Committee including Chapman and Delmonico, but no proponent of incentives (8). The summit was by invitation only, and invitees were invited based on their stance on this issue (Danovitch, personal communication). The few proponents of incentives were vastly, and vociferously, outnumbered. Why are these “consensus” documents immune from challenge?
Second, the DICG is incorrect that our proposal is “belied by the reality of markets.” Again, they conflate “unregulated markets” with the government sponsored regulated systems we propose. As we state: (a) each system would be limited (donors and recipients) to citizens of that country, and (b) the organ would be allocated to the #1 person on the list (i.e. not the rich buying from the poor). Each government-regulated system would be based on donor and recipient protection, regulation, transparency and oversight.
Finally, we resent the innuendo in the suggestions that our manuscript was prompted and “funded in part by Filipino organizations that have favored organ sales to foreigners” and that the authors would accept “permitting the poor and vulnerable in any community to part with a kidney for the wealthy sick.” These are cheap shots unworthy of a discussion so important to our patients. It may be that there is no place for a regulated system of incentives. But that decision should be made after dispassionate, reasoned discussion and ideally after being informed by hard data.
In a second letter, Padilla (another member of DICG) et al., suggest that our proposed system would not work in the Philippines (6). We recognize that there have been mixed evaluations of the programs implemented in both the Philippines and Iran (9). However, neither system of incentives meets the guidelines we have proposed. Moreover, the very fact that successes have been reported suggests that the systems could indeed work and should be improved upon rather than abandoned. We did not state that our system would work in every country, but presented guidelines detailing how systems should be designed in order to be acceptable. Each country would need to have appropriate regulation and oversight and to be able to address wrongdoing."

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