This article was downloaded by: [UQ Library] On: 17 November 2014, At: 01:18 Publisher: Routledge Informa Ltd Registered in England and Wales Registered Number: 1072954 Registered office: Mortimer House, 37-41 Mortimer Street, London W1T 3JH, UK
The American Journal of Bioethics Publication details, including instructions for authors and subscription information: http://www.tandfonline.com/loi/uajb20
Risk, Regulation, and Financial Incentives for Living Kidney Donation a
b
Dominique Martin & Sarah White a
University of Melbourne
b
University of Sydney Published online: 17 Sep 2014.
To cite this article: Dominique Martin & Sarah White (2014) Risk, Regulation, and Financial Incentives for Living Kidney Donation, The American Journal of Bioethics, 14:10, 46-48, DOI: 10.1080/15265161.2014.947045 To link to this article: http://dx.doi.org/10.1080/15265161.2014.947045
PLEASE SCROLL DOWN FOR ARTICLE Taylor & Francis makes every effort to ensure the accuracy of all the information (the “Content”) contained in the publications on our platform. However, Taylor & Francis, our agents, and our licensors make no representations or warranties whatsoever as to the accuracy, completeness, or suitability for any purpose of the Content. Any opinions and views expressed in this publication are the opinions and views of the authors, and are not the views of or endorsed by Taylor & Francis. The accuracy of the Content should not be relied upon and should be independently verified with primary sources of information. Taylor and Francis shall not be liable for any losses, actions, claims, proceedings, demands, costs, expenses, damages, and other liabilities whatsoever or howsoever caused arising directly or indirectly in connection with, in relation to or arising out of the use of the Content. This article may be used for research, teaching, and private study purposes. Any substantial or systematic reproduction, redistribution, reselling, loan, sub-licensing, systematic supply, or distribution in any form to anyone is expressly forbidden. Terms & Conditions of access and use can be found at http:// www.tandfonline.com/page/terms-and-conditions
American Journal of Bioethics
Risk, Regulation, and Financial Incentives for Living Kidney Donation
Downloaded by [UQ Library] at 01:18 17 November 2014
Dominique Martin, University of Melbourne Sarah White, University of Sydney In his comprehensive review of the hazards of existing, largely unregulated markets in human kidneys, Koplin (2014) argues that advocates of regulated markets may underestimate the potential physical, psychosocial and financial harms risked by vendors. He acknowledges, however, that market proponents will likely be undeterred in calling for “trials” or “pilot studies” of financial incentives in developed countries on the grounds that the experience of international black markets is of limited predictive value in anticipating the outcomes of regulated markets. We contend that there is good evidence to support the concern that living vendors would be at higher risk of adverse health outcomes compared to altruistic donors in the context of a regulated market. This has important implications not only for the informed consent of prospective vendors, but also for the potential regulations that would be required to mitigate these risks. We argue here that pilot studies would be at the very least premature until such time as market proponents have sufficiently engaged with potential harms to prospective kidney vendors.
POPULATIONS AT RISK IN A REGULATED KIDNEY MARKET When contrasting black-market experiences in Pakistan, the Philippines, and elsewhere with a hypothetical regulated market in a developed country such as the United States, the relative vulnerability of potential vendors to adverse health and psychosocial outcomes in each setting seems intuitively different. Extreme poverty, high rates of illiteracy, and limited access to health care among vendor populations historically associated with the black market result in outcomes that unsurprisingly compare poorly with the outcomes of altruistic living donation in developed countries. Proponents of a regulated market encourage us to believe that it would be effectively “business as usual”: The status quo of established living donation programs would be maintained, with the exception of an expanded “donor” pool for whom the additional motivation of a financial incentive is required for recruitment. However, as Koplin points out, proponents of regulated markets have failed to address concerns that potential vendors in developed countries would represent a different population from that of historical altruistic living
related donors, and that nephrectomy would be associated with significantly higher long-term risks in this vendor population. The characteristics of the population likely to participate as vendors in a regulated market are difficult to anticipate, as the form and financial magnitude of the incentive that would be offered remains undefined. Few market advocates have outlined specific proposals: With respect to the magnitude of the incentive, The Working Group on Incentives for Living Donation, for example, states only that “the live donor incentive should be of adequate value (and able to improve the donor’s circumstances)” (2012, 308). We assume here that a genuine regulated market would offer potential vendors a monetary payment or fungible equivalent that exceeds any costs that may be incurred throughout requisite screening processes, nephrectomy, and follow-up care. There is little disagreement that poorer individuals would be the most likely population group to consider selling a kidney in a genuine market. Further, it is plausible that those who additionally lack alternative prospects for employment and/or financial capital to address urgent economic needs would be most readily influenced by financial incentives to sell a kidney. Studies evaluating public attitudes toward financial incentives for living kidney vendor recruitment in developed countries suggest that individuals who are younger, from low-income households, or African American may be more likely to consider selling (Boulware et al. 2006; Kranenburg et al. 2008).
EVALUATING RISKS Prospective kidney vendors in a regulated market are thus likely to be young, perhaps disproportionately from minority groups, relatively poor, with limited employment opportunities, and possibly financially insecure. Market proponents (e.g., Hippen 2005, 612) presume that by retaining current screening protocols, eligibility criteria, and follow-up care applied by existing living donation programs, which are designed to minimize donor risks to acceptable standards, kidney vendors will be similarly protected, regardless of their demographic or socioeconomic profile. However, evidence concerning long-term risks of major adverse events, including kidney failure,
Address correspondence to Dominique Martin, The University of Melbourne, Centre for Health and Society, Level 4, 207 Bouverie Street, Carlton, 3053, Australia. E-mail: [email protected]
46 ajob
October, Volume 14, Number 10, 2014
Downloaded by [UQ Library] at 01:18 17 November 2014
Kidney Vendors in Regulated Organ Markets
cardiovascular events, and premature death, is inadequate for this prospective vendor population. This is especially true for younger potential vendors, few of whom would be ineligible for nephrectomy on the basis of medical criteria simply because they are still years away from the peak onset of contraindications such as diabetes, hypertension, and impaired kidney function (Steiner et al. 2014). For this anticipated population of prospective kidney vendors, higher incidence in association with low educational attainment and low household income compound the lifetime risk of developing these contraindications (Centers for Disease Control and Prevention [CDC] 2013). The same circumstances compelling vendors to sell a kidney therefore put this population at higher lifetime risk of subsequently developing absolute contradictions to nephrectomy. Further, this milieu of disadvantage increases the likelihood of poor risk-factor management and adverse outcomes, including subsequent kidney failure (Ward 2008). In countries without universal health coverage, such as the United States, the issue of access to health care over a prospective vendor’s lifetime is one that raises particular concerns for long-term risk management. A significant proportion of prospective vendors may lack health insurance or experience other barriers to accessing health services, potentially compromising management of risk factors for kidney failure and other adverse outcomes. In addition to physical health risks, potential vendor populations may also experience higher rates of mood disorders and other mental illnesses associated with low income (Sareen et al. 2011). Although limited information exists concerning psychosocial outcomes for donors, numerous authors have highlighted the importance of predonation psychological screening and follow-up care to identify the need for counseling or other interventions as required (see, e.g., Dew and Jacobs 2012). In addition to the anxieties associated with elective nephrectomy that are experienced by some living kidney donors, potential vendors could experience psychosocial stress in the form of the stigma that Koplin notes may become associated with regulated market sales. Further, if pressing economic stressors underpin the decision to sell a kidney, vendors may be at higher risk of decision-making regret, especially where long-term financial benefits fail to meet vendor expectations. Even in high-income countries, there is the realistic prospect that kidney vendors would experience further impoverishment as a consequence of disability, inability to work, complications, or unforeseen out-ofpocket health expenditures directly related to nephrectomy. For example, a significant proportion of living related donors in the United States report experiencing financial hardship as a result of recovery from donation (Dew and Jacobs 2012).
would require far greater regulation than market proponents commonly propose. Few specifics of market regulation have been detailed beyond referencing existing regulations governing donor eligibility and assessment criteria in altruistic living donation. For example, the notion of a minimum income requirement for prospective vendors has been considered, but only in the context of debate concerning risks of exploitation and undue inducement of vendors, rather than concerns about long-term health risks that may be associated with a vendor population of low socioeconomic status. Matas (2008, 383) notably raises the possibility of a minimum vendor age of 25 years, but does so in the context of concerns about maturity and decisionmaking competency, rather than prospective evaluation of long-term health outcomes. At least three key points of regulation are likely to be required in a hypothetical regulated market. First, consideration must be given to inclusion of a minimum age limit—35 years, for example—to enable more accurate estimation of lifetime risk of adverse outcomes (Steiner et al 2014) and to improve the quality of consent. Second, in addition to appropriate follow-up care, health insurance coverage for vendors should be assured as a requirement for vendor protection rather than offered as an incentive. Third, expanded psychosocial screening and revised eligibility criteria would be needed to reduce the risk of vendors developing depression and other mental health disorders as a result of selling a kidney in economically constrained circumstances. THE BURDEN OF PROOF Calls for pilot studies of financial incentives are primarily concerned with evaluating their impact on the overall supply of kidneys for transplantation, taking for granted that existing systems will adequately minimize risks to vendors—preventing in particular the kinds of risks and abuses observed in black markets. We believe, however, that there is considerable evidence to indicate that vendors participating in regulated markets in developed countries would be at significant risk of adverse outcomes. Stringent eligibility criteria and access to free, lifelong follow-up care would constitute a minimum requirement to mitigate this risk. Where existing evidence concerning potential risks to vendors is insufficient—for example, with regard to the impact of psychosocial factors on long-term outcomes of nephrectomy—research to address these evidence gaps using data from established altruistic living donor programs should surely take precedence over trials incentivizing vulnerable populations to become kidney vendors. & REFERENCES
ANTICIPATING NECESSARY REGULATION Responding to the increased risks of adverse outcomes associated with financial incentives for kidney “donation”
October, Volume 14, Number 10, 2014
Boulware, L. E., M. U. Troll, N. Y. Wang, and N. R. Powe. 2006. Public attitudes toward incentives for organ donation: A national study of different racial/ethnic and income groups. American Journal of Transplantation 6(11): 2774–2785.
ajob 47
American Journal of Bioethics
Centers for Disease Control and Prevention. 2013. CDC health disparities and inequalities report—United States, 2013. Morbidity & Mortality Weekly Report (MMWR) Supplement, 62(S3): 1–187.
Matas, A. J. 2008. Design of a regulated system of compensation for living kidney donors. Clinical Transplantation 22(3): 378–384.
Dew, M. A., and C. L. Jacobs. 2012. Psychosocial and socioeconomic issues facing the living kidney donor. Advances in Chronic Kidney Disease 19(4): 237–243.
Sareen, J., T. O. Afifi, K. A. McMillan, and G. J. Asmundson. 2011. Relationship between household income and mental disorders: Findings from a population-based longitudinal study. Archives of General Psychiatry 68(4): 419–427.
Hippen, B. E. 2005. In defense of a regulated market in kidneys from living vendors. Journal of Medicine and Philosophy, 30(6): 593– 626.
Steiner, R. W., J. H. Ix, D. E. Rifkin, and B. Gert. 2014. Estimating risks of de novo kidney diseases after living kidney donation. American Journal of Transplantation 14(3): 538–544.
Koplin, J. 2014. Assessing the likely harms to kidney vendors in regulated organ markets. American Journal of Bioethics 14(10): 7–18.
Ward, M. M. 2008. Socioeconomic status and the incidence of ESRD. American Journal of Kidney Disease 51(4): 563–572. Working Group on Incentives for Living Donation. 2012. Incentives for organ donation: Proposed standards for an internationally acceptable system. American Journal of Transplantation 12(2): 306–312.
Downloaded by [UQ Library] at 01:18 17 November 2014
Kranenburg, L., A. Schram, W. Zuidema, et al. 2008. Public survey of financial incentives for kidney donation. Nephrology Dialysis Transplantation 23(3): 1039–1042.
48 ajob
October, Volume 14, Number 10, 2014
The American Journal of Bioethics Publication details, including instructions for authors and subscription information: http://www.tandfonline.com/loi/uajb20
Risk, Regulation, and Financial Incentives for Living Kidney Donation a
b
Dominique Martin & Sarah White a
University of Melbourne
b
University of Sydney Published online: 17 Sep 2014.
To cite this article: Dominique Martin & Sarah White (2014) Risk, Regulation, and Financial Incentives for Living Kidney Donation, The American Journal of Bioethics, 14:10, 46-48, DOI: 10.1080/15265161.2014.947045 To link to this article: http://dx.doi.org/10.1080/15265161.2014.947045
PLEASE SCROLL DOWN FOR ARTICLE Taylor & Francis makes every effort to ensure the accuracy of all the information (the “Content”) contained in the publications on our platform. However, Taylor & Francis, our agents, and our licensors make no representations or warranties whatsoever as to the accuracy, completeness, or suitability for any purpose of the Content. Any opinions and views expressed in this publication are the opinions and views of the authors, and are not the views of or endorsed by Taylor & Francis. The accuracy of the Content should not be relied upon and should be independently verified with primary sources of information. Taylor and Francis shall not be liable for any losses, actions, claims, proceedings, demands, costs, expenses, damages, and other liabilities whatsoever or howsoever caused arising directly or indirectly in connection with, in relation to or arising out of the use of the Content. This article may be used for research, teaching, and private study purposes. Any substantial or systematic reproduction, redistribution, reselling, loan, sub-licensing, systematic supply, or distribution in any form to anyone is expressly forbidden. Terms & Conditions of access and use can be found at http:// www.tandfonline.com/page/terms-and-conditions
American Journal of Bioethics
Risk, Regulation, and Financial Incentives for Living Kidney Donation
Downloaded by [UQ Library] at 01:18 17 November 2014
Dominique Martin, University of Melbourne Sarah White, University of Sydney In his comprehensive review of the hazards of existing, largely unregulated markets in human kidneys, Koplin (2014) argues that advocates of regulated markets may underestimate the potential physical, psychosocial and financial harms risked by vendors. He acknowledges, however, that market proponents will likely be undeterred in calling for “trials” or “pilot studies” of financial incentives in developed countries on the grounds that the experience of international black markets is of limited predictive value in anticipating the outcomes of regulated markets. We contend that there is good evidence to support the concern that living vendors would be at higher risk of adverse health outcomes compared to altruistic donors in the context of a regulated market. This has important implications not only for the informed consent of prospective vendors, but also for the potential regulations that would be required to mitigate these risks. We argue here that pilot studies would be at the very least premature until such time as market proponents have sufficiently engaged with potential harms to prospective kidney vendors.
POPULATIONS AT RISK IN A REGULATED KIDNEY MARKET When contrasting black-market experiences in Pakistan, the Philippines, and elsewhere with a hypothetical regulated market in a developed country such as the United States, the relative vulnerability of potential vendors to adverse health and psychosocial outcomes in each setting seems intuitively different. Extreme poverty, high rates of illiteracy, and limited access to health care among vendor populations historically associated with the black market result in outcomes that unsurprisingly compare poorly with the outcomes of altruistic living donation in developed countries. Proponents of a regulated market encourage us to believe that it would be effectively “business as usual”: The status quo of established living donation programs would be maintained, with the exception of an expanded “donor” pool for whom the additional motivation of a financial incentive is required for recruitment. However, as Koplin points out, proponents of regulated markets have failed to address concerns that potential vendors in developed countries would represent a different population from that of historical altruistic living
related donors, and that nephrectomy would be associated with significantly higher long-term risks in this vendor population. The characteristics of the population likely to participate as vendors in a regulated market are difficult to anticipate, as the form and financial magnitude of the incentive that would be offered remains undefined. Few market advocates have outlined specific proposals: With respect to the magnitude of the incentive, The Working Group on Incentives for Living Donation, for example, states only that “the live donor incentive should be of adequate value (and able to improve the donor’s circumstances)” (2012, 308). We assume here that a genuine regulated market would offer potential vendors a monetary payment or fungible equivalent that exceeds any costs that may be incurred throughout requisite screening processes, nephrectomy, and follow-up care. There is little disagreement that poorer individuals would be the most likely population group to consider selling a kidney in a genuine market. Further, it is plausible that those who additionally lack alternative prospects for employment and/or financial capital to address urgent economic needs would be most readily influenced by financial incentives to sell a kidney. Studies evaluating public attitudes toward financial incentives for living kidney vendor recruitment in developed countries suggest that individuals who are younger, from low-income households, or African American may be more likely to consider selling (Boulware et al. 2006; Kranenburg et al. 2008).
EVALUATING RISKS Prospective kidney vendors in a regulated market are thus likely to be young, perhaps disproportionately from minority groups, relatively poor, with limited employment opportunities, and possibly financially insecure. Market proponents (e.g., Hippen 2005, 612) presume that by retaining current screening protocols, eligibility criteria, and follow-up care applied by existing living donation programs, which are designed to minimize donor risks to acceptable standards, kidney vendors will be similarly protected, regardless of their demographic or socioeconomic profile. However, evidence concerning long-term risks of major adverse events, including kidney failure,
Address correspondence to Dominique Martin, The University of Melbourne, Centre for Health and Society, Level 4, 207 Bouverie Street, Carlton, 3053, Australia. E-mail: [email protected]
46 ajob
October, Volume 14, Number 10, 2014
Downloaded by [UQ Library] at 01:18 17 November 2014
Kidney Vendors in Regulated Organ Markets
cardiovascular events, and premature death, is inadequate for this prospective vendor population. This is especially true for younger potential vendors, few of whom would be ineligible for nephrectomy on the basis of medical criteria simply because they are still years away from the peak onset of contraindications such as diabetes, hypertension, and impaired kidney function (Steiner et al. 2014). For this anticipated population of prospective kidney vendors, higher incidence in association with low educational attainment and low household income compound the lifetime risk of developing these contraindications (Centers for Disease Control and Prevention [CDC] 2013). The same circumstances compelling vendors to sell a kidney therefore put this population at higher lifetime risk of subsequently developing absolute contradictions to nephrectomy. Further, this milieu of disadvantage increases the likelihood of poor risk-factor management and adverse outcomes, including subsequent kidney failure (Ward 2008). In countries without universal health coverage, such as the United States, the issue of access to health care over a prospective vendor’s lifetime is one that raises particular concerns for long-term risk management. A significant proportion of prospective vendors may lack health insurance or experience other barriers to accessing health services, potentially compromising management of risk factors for kidney failure and other adverse outcomes. In addition to physical health risks, potential vendor populations may also experience higher rates of mood disorders and other mental illnesses associated with low income (Sareen et al. 2011). Although limited information exists concerning psychosocial outcomes for donors, numerous authors have highlighted the importance of predonation psychological screening and follow-up care to identify the need for counseling or other interventions as required (see, e.g., Dew and Jacobs 2012). In addition to the anxieties associated with elective nephrectomy that are experienced by some living kidney donors, potential vendors could experience psychosocial stress in the form of the stigma that Koplin notes may become associated with regulated market sales. Further, if pressing economic stressors underpin the decision to sell a kidney, vendors may be at higher risk of decision-making regret, especially where long-term financial benefits fail to meet vendor expectations. Even in high-income countries, there is the realistic prospect that kidney vendors would experience further impoverishment as a consequence of disability, inability to work, complications, or unforeseen out-ofpocket health expenditures directly related to nephrectomy. For example, a significant proportion of living related donors in the United States report experiencing financial hardship as a result of recovery from donation (Dew and Jacobs 2012).
would require far greater regulation than market proponents commonly propose. Few specifics of market regulation have been detailed beyond referencing existing regulations governing donor eligibility and assessment criteria in altruistic living donation. For example, the notion of a minimum income requirement for prospective vendors has been considered, but only in the context of debate concerning risks of exploitation and undue inducement of vendors, rather than concerns about long-term health risks that may be associated with a vendor population of low socioeconomic status. Matas (2008, 383) notably raises the possibility of a minimum vendor age of 25 years, but does so in the context of concerns about maturity and decisionmaking competency, rather than prospective evaluation of long-term health outcomes. At least three key points of regulation are likely to be required in a hypothetical regulated market. First, consideration must be given to inclusion of a minimum age limit—35 years, for example—to enable more accurate estimation of lifetime risk of adverse outcomes (Steiner et al 2014) and to improve the quality of consent. Second, in addition to appropriate follow-up care, health insurance coverage for vendors should be assured as a requirement for vendor protection rather than offered as an incentive. Third, expanded psychosocial screening and revised eligibility criteria would be needed to reduce the risk of vendors developing depression and other mental health disorders as a result of selling a kidney in economically constrained circumstances. THE BURDEN OF PROOF Calls for pilot studies of financial incentives are primarily concerned with evaluating their impact on the overall supply of kidneys for transplantation, taking for granted that existing systems will adequately minimize risks to vendors—preventing in particular the kinds of risks and abuses observed in black markets. We believe, however, that there is considerable evidence to indicate that vendors participating in regulated markets in developed countries would be at significant risk of adverse outcomes. Stringent eligibility criteria and access to free, lifelong follow-up care would constitute a minimum requirement to mitigate this risk. Where existing evidence concerning potential risks to vendors is insufficient—for example, with regard to the impact of psychosocial factors on long-term outcomes of nephrectomy—research to address these evidence gaps using data from established altruistic living donor programs should surely take precedence over trials incentivizing vulnerable populations to become kidney vendors. & REFERENCES
ANTICIPATING NECESSARY REGULATION Responding to the increased risks of adverse outcomes associated with financial incentives for kidney “donation”
October, Volume 14, Number 10, 2014
Boulware, L. E., M. U. Troll, N. Y. Wang, and N. R. Powe. 2006. Public attitudes toward incentives for organ donation: A national study of different racial/ethnic and income groups. American Journal of Transplantation 6(11): 2774–2785.
ajob 47
American Journal of Bioethics
Centers for Disease Control and Prevention. 2013. CDC health disparities and inequalities report—United States, 2013. Morbidity & Mortality Weekly Report (MMWR) Supplement, 62(S3): 1–187.
Matas, A. J. 2008. Design of a regulated system of compensation for living kidney donors. Clinical Transplantation 22(3): 378–384.
Dew, M. A., and C. L. Jacobs. 2012. Psychosocial and socioeconomic issues facing the living kidney donor. Advances in Chronic Kidney Disease 19(4): 237–243.
Sareen, J., T. O. Afifi, K. A. McMillan, and G. J. Asmundson. 2011. Relationship between household income and mental disorders: Findings from a population-based longitudinal study. Archives of General Psychiatry 68(4): 419–427.
Hippen, B. E. 2005. In defense of a regulated market in kidneys from living vendors. Journal of Medicine and Philosophy, 30(6): 593– 626.
Steiner, R. W., J. H. Ix, D. E. Rifkin, and B. Gert. 2014. Estimating risks of de novo kidney diseases after living kidney donation. American Journal of Transplantation 14(3): 538–544.
Koplin, J. 2014. Assessing the likely harms to kidney vendors in regulated organ markets. American Journal of Bioethics 14(10): 7–18.
Ward, M. M. 2008. Socioeconomic status and the incidence of ESRD. American Journal of Kidney Disease 51(4): 563–572. Working Group on Incentives for Living Donation. 2012. Incentives for organ donation: Proposed standards for an internationally acceptable system. American Journal of Transplantation 12(2): 306–312.
Downloaded by [UQ Library] at 01:18 17 November 2014
Kranenburg, L., A. Schram, W. Zuidema, et al. 2008. Public survey of financial incentives for kidney donation. Nephrology Dialysis Transplantation 23(3): 1039–1042.
48 ajob
October, Volume 14, Number 10, 2014
