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Regulated Payments for Living Kidney Donation: An Empirical Assessment of the Ethical Concerns

Scott D. Halpern, MD, PhD, MBioethics; Amelie Raz; Rachel Kohn, BA; Michael Rey, BA; David A. Asch, MD, MBA; and Peter Reese, MD, MSCE
[+] Article and Author Information

From the University of Pennsylvania School of Medicine and Philadelphia Veterans Affairs Medical Center, Philadelphia, Pennsylvania.


Acknowledgment: The authors thank Thomas R. Ten Have, PhD, and Mark Cary, PhD, for their assistance in the design and analysis of this study.

Grant Support: By a Greenwall Foundation Faculty Scholar Award in Bioethics (Dr. Halpern), the National Institutes of Health (Dr. Reese; grant K23-078688-01), and internships from the University of Pennsylvania Center for Bioethics (Ms. Raz, Ms. Kohn, and Mr. Rey).

Potential Conflicts of Interest: Disclosures can be viewed at www.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum=M09-2133.

Reproducible Research Statement:Study protocol, statistical code, and data set: Available from Dr. Halpern (e-mail, scott.halpern@uphs.upenn.edu).

Requests for Single Reprints: Scott D. Halpern, MD, PhD, MBioethics, University of Pennsylvania School of Medicine, 724 Blockley Hall, 423 Guardian Drive, Philadelphia, PA 19104-6021; e-mail, scott.halpern@uphs.upenn.edu.

Current Author Addresses: Dr. Halpern: University of Pennsylvania School of Medicine, 724 Blockley Hall, 423 Guardian Drive, Philadelphia, PA 19104-6021.

Ms. Raz: Box C-826, 101 North Merion Avenue, Bryn Mawr, PA 19010.

Ms. Kohn: 2400 Chestnut Street, Apartment 3301, Philadelphia, PA 19103.

Mr. Rey: Mailbox 534, University of Pennsylvania School of Medicine, 3450 Hamilton Walk, Stemmler 100, Philadelphia, PA 19104.

Dr. Asch: Suite 210, Colonial Penn Center, 3641 Locust Walk, Philadelphia, PA 19104.

Dr. Reese: 908 Blockley Hall, 423 Guardian Drive, Philadelphia, PA 19104.

Author Contributions: Conception and design: S.D. Halpern, A. Raz, D.A. Asch, P. Reese.

Analysis and interpretation of the data: S.D. Halpern, M. Rey, D.A. Asch, P. Reese.

Drafting of the article: S.D. Halpern, P. Reese.

Critical revision of the article for important intellectual content: S.D. Halpern, A. Raz, D.A. Asch.

Final approval of the article: S.D. Halpern, A. Raz, D.A. Asch, P. Reese.

Statistical expertise: S.D. Halpern.

Obtaining of funding: S.D. Halpern.

Administrative, technical, or logistic support: S.D. Halpern, A. Raz.

Collection and assembly of data: R. Kohn, M. Rey.


Ann Intern Med. 2010;152(6):358-365. doi:10.7326/0003-4819-152-6-201003160-00005
Text Size: A A A

Background: Although regulated payments to encourage living kidney donation could reduce morbidity and mortality among patients waiting for a kidney transplant, doing so raises several ethical concerns.

Objective: To determine the extent to which the 3 main concerns with paying kidney donors might manifest if a regulated market were created.

Design: Cross-sectional study of participants' willingness to donate a kidney in 12 scenarios.

Setting: Regional rail and urban trolley lines in Philadelphia County, Philadelphia, Pennsylvania.

Participants: Of 550 potential participants, 409 completed the questionnaire (response rate, 74.4%); 342 of these participants were medically eligible to donate.

Intervention: Across scenarios, researchers experimentally manipulated the amount of money that participants would receive, the participants' risk for subsequently developing kidney failure themselves, and who would receive the donated kidney.

Measurements: The researchers determined whether payment represents an undue inducement by evaluating participants' sensitivity to risk in relation to the payment offered or an unjust inducement by evaluating participants' sensitivity to payment as a function of their annual income. The researchers also evaluated whether introducing payment would hinder altruistic donations by comparing participants' willingness to donate altruistically before versus after the introduction of payments.

Results: Generalized estimating equation models revealed that participants' willingness to donate increased significantly as their risk for kidney failure decreased, as the payment offered increased, and when the kidney recipient was a family member rather than a patient on a public waiting list (P < 0.001 for each). No statistical interactions were identified between payment and risk (odds ratio, 1.00 [95% CI, 0.96 to 1.03]) or between payment and income (odds ratio, 1.01 [CI, 0.99 to 1.03]). The proximity of these estimates to 1.0 and narrowness of the CIs suggest that payment is neither an undue nor an unjust inducement, respectively. Alerting participants to the possibility of payment did not alter their willingness to donate for altruistic reasons (P = 0.40).

Limitation: Choices revealed in hypothetical scenarios may not reflect real-world behaviors.

Conclusion: Theoretical concerns about paying persons for living kidney donation are not corroborated by empirical evidence. A real-world test of regulated payments for kidney donation is needed to definitively show whether payment provides a viable and ethical method to increase the supply of kidneys available for transplantation.

Primary Funding Source: None.

Topics

ethics ; kidney

Figures

Grahic Jump Location
Figure 1.
Study flow diagram.

* Participants with any of the following criteria were considered clinically ineligible to donate: age >65 years; current kidney disease; congenital solitary kidney; family history of polycystic kidney disease; or history of heart disease, high blood pressure requiring more than 1 medication, diabetes, cancer, or hepatitis.

Grahic Jump Location
Grahic Jump Location
Figure 2.
Adjusted proportions of participants willing to donate a kidney to family members and to patients on the waiting list as functions of payment and risk.

Scenarios in which donors would receive payment of $100 000, payment of $10 000, or no payment are illustrated. As evident from the roughly parallel nature of the lines within each recipient group, no interaction between risk and payment occurred when the recipient was a family member (odds ratio, 0.99 [95% CI, 0.94–1.04]) or when the recipient was the next patient on the waiting list (odds ratio, 0.97 [CI, 0.93–1.01]).

Grahic Jump Location
Grahic Jump Location
Figure 3.
Adjusted proportions of participants willing to donate a kidney to a patient on the waiting list as a function of income and payment.

Participants whose annual household incomes were ≤$20 000 through >$100 000 are illustrated. The plotted proportions have been adjusted for risk for renal failure, donor age, donor sex, version of the survey packet received, and interval of participant recruitment. Error bars represent 95% CIs around each adjusted proportion. As evident from the roughly parallel nature of the lines, no interaction between payment and income occurred (odds ratio, 1.01 [95% CI, 0.99–1.03]).

Grahic Jump Location

Tables

References

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Comments

Submit a Comment
Encourage Organ donors for they are Life Savers
Posted on March 16, 2010
dhastagir sultan Sheriff
Al Arab Medical University, Benghazi
Conflict of Interest: None Declared

The number of people who need a kidney transplant outweighs the number of kidneys available. One way to motivate more living people to donate kidneys might be to have a carefully regulated, national system that provides fixed payments to kidney donors. However, some worry that offering payment for kidneys could create problems.

First, people might donate kidneys without fully considering their own health.

Second, payment might push poor people into donating kidneys.

Third, people might be less likely to donate a kidney just to help another person.

However, because we do not have such a payment system, we do not know whether some of these unwanted results would really happen. What is payment? It is a very difficult term to define excepting to say that an incentive given to the service rendered on request. This payment could be fees, salary or professional charges. These modes of payment may be regulated through guidelines stipulated by the body that offers these payments. An attending physician or surgeon demands a fee for the services he or she renders to the patient. It is acceptable by the society and considered reasonable and respectable. When one volunteers to donate an organ the fee the donor fixes for the donation becomes a point of great controversy. This controversy arises because the donors most of them hail from economically downtrodden strata of society. The the use and abuse of such donors did exist even for blood donation. Then blood donation became a life-saving industry where national bodies regulate their function. Why not organ donation? It is so critical to save lives and patients are willing to a pay a price for such a donation. When there is a mutual consent and a regulatory body to minimize abuse and maximize organ donation, organ banks could become a reality in a world where we have sperm banks and gene banks. It is high time there is an international consensus on such a vital life- saving issue to set ethical guidelines and practical procedures to make organ donation an altruistic but a medical necessity in the ever-growing market of human industry.

Conflict of Interest:

None declared

Any Attempt to Regulate Payments for Living Kidney Donation is Premature
Posted on March 16, 2010
G. V. Ramesh Prasad
St. Michael's Hospital, University of Toronto
Conflict of Interest: None Declared

Dear Sir,

In their article (1) Halpern and colleagues propose a real-world test of regulated payments for kidney donation to demonstrate if such a system is viable and ethical in the United States. This proposal is neither viable nor ethical in the real world of 2010.

A basic requirement to the design of such a study, of which the authors remain vague, is the demonstration of true clinical equipoise. There are no national registries that capture any long-term donor-related outcomes, either in countries where commercial donation is illegal such as the United States, or legal such as Iran (2). In the latter country, serious ethical challenges have emerged despite a 20-year experience with such a system (3). Countries with universal health care systems such as India report poor outcomes in commercial donors (4), and have banned the practice. More definitive single-center reports of long-term donor safety within a legal system have only recently emerged (5). The United States is yet to create any systematic method for data capture of medical events in donors besides their listing for kidney transplantation themselves. Clinical equipoise cannot exist when there are no reports of long-term safety, even anecdotal, in commercial donors. Halpern and colleagues also fundamentally assume that economically disadvantaged poor Americans have true autonomy in arriving at a decision to donate. This is critical to their interpretation that payment provides neither undue nor unjust inducement.

The authors have also overlooked commercial transplant recipient outcomes (6), which are quite poor in North America (7,8). Although a closely monitored, regulated system might limit recipient complications in the United States, the permissibility of domestic commercialism while prohibiting more affordable transplant tourism remains debatable. Despite government payments to donors in a regulated system most compensation comes from the recipient (3). Recipient health can be seriously jeopardized by depleted personal resources. Therefore second to clinical equipoise, having an assured national universal health care access policy in place would be essential prior to embarking on a test of regulated payments.

Finally, less than 1 million kidney transplants have been performed in 521 centers worldwide to date. The high percentage of study participants (15%) who know either a recipient or donor (1) argues against external validity and clinical equipoise. While Halpern and colleagues provide important information to the debate on legalizing transplant commercialism, any attempts at conducting a clinical study are very premature.

References

1. Halpern SD, Raz A, Kohn R, Rey M, Asch DA, Reese P. Regulated payments for living kidney donation: An empirical assessment of the ethical concerns. Ann Int Med 2010; 152:358-365.

2. Ghods AJ, Savaj S. Iranian model of paid and regulated living- unrelated kidney donation. Clin J Am Soc Nephrol 2006; 1:1136-1145.

3. Ghods AJ. Ethical issues and living unrelated donor kidney transplantation. Iran J Kidney Dis 2009; 3:183-191.

4. Goyal M, Mehta RL, Schneiderman LJ, Sehgal AR. Economic and health consequences of selling a kidney in India. JAMA 2002; 288:1589-1593.

5. Ibrahim HN, Foley R, Tan L, Rogers T, Bailey RF, Guo H, Gross CR, Matas AJ. Long-term consequences of kidney donation. N Engl J Med 2009; 360:459-469.

6. Commercialization of kidney transplants: A systematic review of outcomes in recipients and donors. Am J Nephrol 2008; 28:744-754.

7. Prasad GV, Shukla A, Huang M, Honey RJ, Zaltzman JS. Outcomes of commercial renal transplantation: A Canadian experience. Transplantation 2006; 82:1130-1135.

8. Gill J, Madhira BR, Gjertson D, Lipshutz G, Cecka JM, Pham PT, Wilkinson A, Bunnapradist S, Danovitch GM. Transplant tourism in the United States: A single-center experience. Clin J Am Soc Nephrol 2008; 3:1820-1828.

Conflict of Interest:

None declared

Regulated payments for Living Kidney Donation should be allowed in India
Posted on March 19, 2010
Dr.Hriday Ranjan Das
IPGMER&SSKM Hospital, Kolkata,INDIA
Conflict of Interest: None Declared

In india incidence of Chronic Kidney Disease is increasing rapidly. The cost of Maintainance Haemodialysis is huge in India. Majority of these CKD patients can not afford Maintainance Haemodialysis.But surgical costs of Renal Transplantaton is affordable by most patients in government run hospitals in india. In addition the cost immunosuppesive drugs have become much lesser ,because thesse drugs are being manufactured by Indian pharmaceutcal companies indigenously. Cadaver Transplantation has still remained a pipe dream in most of the kidney transplant centers in India . On the other hand living related kidney donor is available only in a fraction of cases .So most of the patients will be benifitted if regulated payments for Living Kidney Donation is allowed inIndia

Conflict of Interest:

None declared

Compensation for Kidney Donation
Posted on March 24, 2010
Amesh Adalja
University of Pittsburgh
Conflict of Interest: None Declared

Halpern et al.'s study regarding monetary compensation for living kidney donors is encouraging not because of its results, but because it indicates that an unjustified taboo against discussing these topics is beginning to be lifted (1). Irrespective of concepts such as undue and unjust inducements, the fact remains that a person has a right to liberty which includes complete sovereignty over their body (2,3). Wedding live organ donation to altruism, as Braddock and Magnus do in their accompanying editorial, has not (and will not) resolve the shortage of donor kidneys (4). This is especially a dubious reason given that kidney donation does not alter lifespan (5). It is only by embracing the fact that a person should have complete autonomy over their body can this crisis be averted. It is a paradoxical state of affairs when a theocratic dictatorship such as Iran does not suffer from this same predicament.

References

1. Halpern SD, Raz A, Kohn R, et al. Regulated payments for kidney donation: an empirical assessment of the ethical concerns. Ann Intern Med. 2010; 152:358-365.

2. Locke J. Two treatises of government. New York: Mentor Books; 1963.

3. Rand A. Man's rights. In: Rand, A. The Virtue of Selfishness. New York: Penguin Books; 1964.

4. Braddock CH, Magnus D. Empirical methods in bioethics: a cautionary tale. Ann Intern Med. 2010; 152:396-397.

5. Segev DL, Muzaale AD, Caffo BS, et al. Perioperative mortality and long-term survival following live kidney donation. JAMA. 2010;303:959-966.

Conflict of Interest:

None declared

Purchase of live kidney for transplant is intrinsically unethical...
Posted on March 28, 2010
Professor Pranab Kumar Bhattacharya MD(cal) FIC path(Ind)
Institute of Post Graduate Medical Education Research 244a aJC Bose Road kol-20 West Bengal India
Conflict of Interest: None Declared

Purchase or selling of Kidney or any other organs for purpose of recipient's transplantation is strictly prohibited in India by the laws and is a criminal offence. Only a charitable donation/ altruistic donation to help a person in CRF to live in this planet, by a HLA matched healthy relative or non HLA matched related or may be unrelated donor is permissible by the law with approval of a state level ethical committee and affidavit in the court of laws, [following criteria are considered clinically ineligible to donate a kidney: age _65 years; current kidney disease; congenital solitary kidney; family history of polycystic kidney disease; or history of heart disease, high blood pressure requiring more than 1 medication, diabetes, cancer ]. But the demands for Kidney transplantation is increasing mostly in upper middle class strata and in richer class families [High Income Strata] as because there is sharp rise of Type2 Diabetes mellitus and resultant CRF patients in those. More over live donor kidney transplant cost is much less then life time dialysis cost. Dialysis is often not accessible in every urban districts of west Bengal for every CRF patients according to needs. So Kidney transplant is the long term solution. It is no doubt a fact that kidney transplant from living donors produces greater benefits to recipients, then when donor kidney is taken from brain death patients or a cadaver and graft rejection is more. Donor Kidney when transplanted from brain death patients' may have acute tubular necrosis. The result is good particularly when kidney transplantation from live donors is done before recipients initiate dialysis. As such cadaver donor[donors after circulatory determination of death] or brain death donor's kidney transplantation in Kolkata is not at all practiced and Live donors Kidney always thus create an unfair market in kolkata metropolis of India, in which organs are acquired mostly from the poor persons of villages or of rural areas or of slums or from unemployed young[ lower house hold income and lower level of education high school or less], when these people are forced to sell their organ to collect money for family needs[ either for a social marriage of his sister /daughter or to meet for his/her very kin's higher education cost or for some closest one's treatment at private health care set up]. The reality is that donation of kidney from graduate or higher educated and higher/middle income strata is very less,[<5% in India]. This high stratum People takes advantages of undue inducement to less educated and needy unrelated donors. But the fact is that often the donor is provided with in sufficient payments in Indian Rupees. In US for donation of a kidney it cost Us$ 20,000 to Us$ 1,00,000 [1] depending on interaction and annual house hold income of donor. The donor people are often not provided with sufficient information about the risk for donation of one kidney in his/her future life and also present risks associated with donor nephrectomy. Donors themselves are often tolerant of greater personal risks like future renal failure and the percentage of living kidney donors expected to develop renal failure requiring dialysis, transplantation, or both in the future [0.1%, 1%, or 10%]),[1] .Safeguards to protect donors are largely absent, brokers rather than donors may commandeer most of the payments, and such systems almost invariably entail wealthy people purchasing organs from poor . A big question remain, why not related brothers/sisters/ HLA matched husband wife/parents or any other healthy persons of wealthy family become a living donors for their loved one or become an altruistic donor? Why do they depend on market? The median time to transplantation, number of patients on the waiting list, and number of patients who die while waiting for an organ continue to increases in first world counties also as such in Health Tourism of West Bengal wealthy travelers will next be purchasing organs from poor natives: Money will encourage no doubt greater kidney donation, or willingness to donate by poor. Payments will influence poorer people'¢s more than richer persons to sell organ and will establish, an unfair open market for kidney sell.

References

1] Scott D. Halpern, MD, PhD, MBioethics; Amelie Raz; Rachel Kohn, BA; Michael Rey, BA; David A. Asch, MD, MBA; "Regulated Payments for Living Kidney Donation: An Empirical Assessment of the Ethical Concerns." Annals of Internal Medicine 2010;152:358-365.

Conflict of Interest:

None declared

Lack of interaction between payment, risk and donor income...
Posted on April 5, 2010
Mark R. Tonelli
University of Washington, Department of Medicine, Division of Pulmonary and Critical Care Medicine
Conflict of Interest: None Declared

To the Editor:

Halpern and colleagues use the results of a survey of adults in Philadelphia regarding willingness to donate a kidney under various conditions of risk and reimbursement to support a call for a regulated and geographically limited test of paying persons to furnish a kidney to a waiting list recipient (1). The analysis focuses on the lack of an interaction between payment, risk and donor income with willingness to offer an organ, suggesting no undue or unjust inducement from schemes that pay for organs. However, a single piece of data from the study suggests that there is no reason whatsoever for us to ever consider offering payment for organs.

According to the survey, fully 1 in 6 adults in the City of Brotherly Love is willing to donate a kidney to an unknown patient on the waiting list without any offer of reimbursement, even with a 10% chance of eventually developing renal failure (Figure 2). Such a high frequency of altruism and self-sacrifice would seem to obviate the need for any payment scheme for organs, as the adult population of Philadelphia would easily supply enough kidneys to transplant all 84,000 patients currently on the waiting list. This observation would support the conculsion that we just need to start asking more people to donate kidneys to strangers, rather than offering to pay them to do so.

Alternatively, we might suspect that survey respondents were inclinedd to overemphasize their altruism. Such a tendency is certainly understandable, and is likely associated with a tendency to underemphasize one's venality. As Braddock and Magnus make clear in accompanying editorial, we cannot assume that any action is right just because most peopole choose it (2). Even more to the point, we should be extremely skeptical that poeple will do the right things just because they say they will.

References

1. Halpern SD, Raz A, Kohn R, et al. Regulated Payments for Living Kidney Donation: An Empirical Assessment of the Ethical Concerns. Ann Int Med 2010; 152:358-365

2. Braddock CH, Magnus D. Empirical methods in bioethics: a cautionary tale. Ann Int Med 2010;152:396-397

Conflict of Interest:

None declared

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Summary for Patients

The Ethics of Offering Payment to Living People Who Donate a Kidney

The summary below is from the full report titled “Regulated Payments for Living Kidney Donation: An Empirical Assessment of the Ethical Concerns.” It is in the 16 March 2010 issue of Annals of Internal Medicine (volume 152, pages 358-365). The authors are S.D. Halpern, A. Raz, R. Kohn, M. Rey, D.A. Asch, and P. Reese.

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