A regulated system of incentives for living kidney donation: Clearing the way for an informed assessment

Abstract

The kidney shortage continues to be a crisis for our patients. Despite numerous attempts to increase living and deceased donation, annually in the United States, thousands of candidates are removed from the kidney transplant waiting list because of either death or becoming too sick to transplant. To increase living donation, trials of a regulated system of incentives for living donation have been proposed. Such trials may show: (1) a significant increase in donation, and (2) that informed, incentivized donors, making an autonomous decision to donate, have the same medical and psychosocial outcomes as our conventional donors. Given the stakes, the proposal warrants careful consideration. However, to date, much discussion of the proposal has been unproductive. Objections commonly leveled against it: fail to engage with it; conflate it with underground, unregulated markets; speculate without evidence; and reason fallaciously, favoring rhetorical impact over logic. The present paper is a corrective. It identifies these common errors so they are not repeated, thus allowing space for an assessment of the proposal on its merits. The kidney shortage continues to be a crisis for our patients. Despite numerous attempts to increase living and deceased donation, annually in the United States, thousands of candidates are removed from the kidney transplant waiting list because of either death or becoming too sick to transplant. To increase living donation, trials of a regulated system of incentives for living donation have been proposed. Such trials may show: (1) a significant increase in donation, and (2) that informed, incentivized donors, making an autonomous decision to donate, have the same medical and psychosocial outcomes as our conventional donors. Given the stakes, the proposal warrants careful consideration. However, to date, much discussion of the proposal has been unproductive. Objections commonly leveled against it: fail to engage with it; conflate it with underground, unregulated markets; speculate without evidence; and reason fallaciously, favoring rhetorical impact over logic. The present paper is a corrective. It identifies these common errors so they are not repeated, thus allowing space for an assessment of the proposal on its merits. The concept of incentives for living donation arose early in the history of kidney transplantation. In the 1960s, the framers of the Uniform Anatomical Gift Act noted “every payment is not necessarily unethical”, but “until the matter of payment becomes a problem of some dimensions, the matter should be left to the decency of intelligent human beings”.1Stason E The uniform anatomical gift act.Business Lawyer (ABA). 1968; 23: 919-930Google Scholar In 1983, the matter of payment became a problem when, in response to the organ shortage, a physician (whose license had previously been revoked) established a company to broker international kidney sales. Impoverished residents of low-income countries were to be flown to the United States to sell their kidneys at a nominal price. This was met with general condemnation, and in part, led to passage of the National Organ Transplant Act (NOTA, Public Law 98–507) which made it a federal crime to “knowingly acquire, receive or otherwise transfer any human organ for valuable consideration for use in human transplantation…”. At the same time, the World Medical Association, the World Health Organization, the Council of Europe, and the International Council of the Transplantation Society, among others, issued statements of opposition to the sale of organs. Over subsequent decades, improving transplant outcomes led to expansion of candidacy criteria (e.g., older, more comorbidities), resulting in rapid growth in the number of patients on the kidney transplant waiting list. However, there was not a commensurate increase in organ donation. As a consequence, there were long waiting times for a deceased donor transplant, a high waitlist mortality, and an increasing number of candidates being removed from the list because of becoming too sick to transplant. Innovations in living (e.g., nondirected donation, paired exchange) and deceased donation (e.g., donation after circulatory death) have led to a 45% increase in the number of kidney transplants in the last decade. Yet, this has made no dent in waitlist morbidity or mortality. Annually in the United States approximately 8000 waitlisted transplant candidates die or are removed from the list because they have become too sick to transplant.2OPTN data. Accessed August 22, 2021. https://optn.transplant.hrsa.gov/data/Google Scholar Sadly, even this figure underestimates the extent of the shortage. In 2008, Schold et al. reported that over 135 000 patients on dialysis had >5-year life expectancy and were potentially good transplant candidates but were not listed.3Schold JD Srinivas TR Kayler LK Meier-Kriesche HU The overlapping risk profile between dialysis patients listed and not listed for renal transplantation.Am J Transplant. 2008; 8: 58-68Abstract Full Text Full Text PDF PubMed Scopus (58) Google Scholar One consequence of the shortage has been the emergence of underground, unregulated markets for kidneys. Patients with end stage kidney disease (ESKD) from wealthy countries, aided by a broker, travel to poor- or middle-income countries to purchase a kidney. In these underground markets, neither donor nor recipient are protected. This practice is widely condemned by both the general and transplant communities. This situation—increasing demand, limited supply—has prompted ongoing discussion of incentives. In 1989, bioethicist James Childress wrote “If a system of donation with various modifications proves to be insufficiently effective, then trials of sales could be considered."4Childress JF Ethical criteria for procuring and distributing organs for transplantation.J Health Polit Policy Law. 1989; 14: 87-113Crossref PubMed Scopus (62) Google Scholar In 1997, the Bellagio Task Force on Transplantation, Body Integrity, and the International Traffic in Organs found that the international proclamations condemning the purchase of organs failed to provide a rationale for their decision, instead issuing statements “in one or two short sentences with no supporting arguments”.5Rothman DJ Rose E Awaya T et al.The Bellagio Task Force report on transplantation, bodily integrity, and the International Traffic in Organs.Transplant Proc. 1997; 29: 2739-2745Crossref PubMed Scopus (72) Google Scholar The task force concluded that there was “no unarguable ethical principle that would justify a ban on sale under all circumstances”. The next year, the International Forum for Transplant Ethics stated that the discussion of incentives should be re-opened; and given the potential benefit, the “burden of proof” rests on “the defenders of prohibition”.6Radcliffe-Richards J Daar AS Guttmann RD et al.The case for allowing kidney sales.International Forum for Transplant Ethics Lancet. 1998; 351: 1950-1952Scopus (240) Google Scholar Later, in 2006, an Institute of Medicine report recommended that a pilot study of the effect of incentives should be undertaken “if other, less controversial strategies … have been tried and proven unsuccessful.”7Childress JF Liverman CT Organ Donation: Opportunities for Action.. The National Academies Press, 2006Google Scholar The moral justification for incentivized donation is, in part, the same as that which justifies non-incentivized donation. The potential benefits to the recipient, the waiting list and society, and the informed autonomous decision of the donor candidate are balanced against the potential harm to the donor. Living kidney donation has long been allowed, even encouraged. We find it admirable and appropriate that a father might donate a kidney to his daughter suffering from ESKD. But suppose that his daughter needed cancer treatment and he sought to exchange his kidney in order to finance it. Here, too, we should regard the father’s conduct as admirable and appropriate. The mere involvement of an incentive does not transform his life-saving act into a moral transgression. Of course, the fact that incentivized donation could be morally justified does not imply that, in practice, it would be. The questions, then, are these: Can a regulated system of incentives be designed to operate ethically? Is it reasonable to undertake trials of incentives to assess benefits and risks? Is there a specific reason or combinations of reasons not to move forward with trials (assuming they were legal)? Given the continuing morbidity and mortality on the waiting list, and the potential benefits of a regulated system of incentives, trials have been proposed.8Matas AJ Satel S et al.Working Group on Incentives for Living DonationIncentives for organ donation: proposed standards for an internationally acceptable system.Am J Transplant. 2012; 12: 306-312Abstract Full Text Full Text PDF PubMed Scopus (78) Google Scholar, 9Fisher JS Butt Z Friedewald J et al.Between Scylla and Charybdis: charting an ethical course for research into financial incentives for living kidney donation.Am J Transplant. 2015; 15: 1180-1186Abstract Full Text Full Text PDF PubMed Scopus (17) Google Scholar, 10Salomon DR Langnas AN Reed AI et al.AST/ASTS workshop on increasing organ donation in the United States: creating an "arc of change" from removing disincentives to testing incentives.Am J Transplant. 2015; 15: 1173-1179Abstract Full Text Full Text PDF PubMed Scopus (47) Google Scholar Trials would answer many outstanding questions: whether living donation increases; whether conventional living donation decreases, and whether that matters; whether disadvantaged and marginalized populations exclusively participate; whether donor and recipient outcomes differ from conventional donation; whether incentivized donors feel exploited or regretful; whether deceased donation decreases.8Matas AJ Satel S et al.Working Group on Incentives for Living DonationIncentives for organ donation: proposed standards for an internationally acceptable system.Am J Transplant. 2012; 12: 306-312Abstract Full Text Full Text PDF PubMed Scopus (78) Google Scholar, 9Fisher JS Butt Z Friedewald J et al.Between Scylla and Charybdis: charting an ethical course for research into financial incentives for living kidney donation.Am J Transplant. 2015; 15: 1180-1186Abstract Full Text Full Text PDF PubMed Scopus (17) Google Scholar, 10Salomon DR Langnas AN Reed AI et al.AST/ASTS workshop on increasing organ donation in the United States: creating an "arc of change" from removing disincentives to testing incentives.Am J Transplant. 2015; 15: 1173-1179Abstract Full Text Full Text PDF PubMed Scopus (47) Google Scholar Guidelines for a regulated system of incentives trials have been developed (Table 1).8Matas AJ Satel S et al.Working Group on Incentives for Living DonationIncentives for organ donation: proposed standards for an internationally acceptable system.Am J Transplant. 2012; 12: 306-312Abstract Full Text Full Text PDF PubMed Scopus (78) Google Scholar,11Matas AJ Design of a regulated system of compensation for living kidney donors.Clin Transplant. 2008; 22: 378-384Crossref PubMed Scopus (20) Google Scholar The essential characteristics are as follows. There would be thorough screening of donor candidates with well-defined acceptance criteria; rigorous informed consent procedures; provision of follow-up care; and anonymity between donor and To follow-up is and to study of the residents could of kidneys would be by an to that of deceased donor kidneys in the United States so that on the list has a to receive a transplant. 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