WSJ: "I gave away a kidney, would you sell one?"

Dimitri Linde, a non-directed donor who started a kidney exchange chain writes in the WSJ yesterday:

I Gave Away a Kidney. Would You Sell One?

...
"To obviate the kidney shortage, we should heed the recommendation of Nobel Prize-winning economist Gary Becker and others by making it legal to compensate donors. Currently, the National Organ Transplant Act bans the "sale" of any human organs in the U.S. Those who oppose compensation object to its ramifications for donors and society. They argue that the poor will be exploited, and that people should give out of the goodness of their hearts.

But these lofty sentiments ignore the fact that 18 transplant candidates die each day. As the legal scholar Richard Epstein has put it: "Only a bioethicist could prefer a world in which we have 1,000 altruists per annum and over 6,500 excess deaths over one in which we have no altruists and no excess deaths."

Yet absent such policy changes, which have little traction in Washington, right now transplant chains are the best tool to facilitate donations. Chains begin with a would-be recipient identifying a donor—say, a man with polycystic kidney disease and his wife. In most cases, a potential donor doesn't have a compatible blood and tissue type with the intended recipient, so this spousal pair would likely be a poor match. (Incompatibility can marginalize the life span of the transplant, or preclude the body from accepting it at all.)

That's where organizations like the National Kidney Registry, a nonprofit computerized matching service, come in. The NKR and similar nonprofits work with hospitals across the U.S. to create large national exchanges, linking incompatible and poorly compatible pairs to highly compatible counterparts elsewhere. Additionally, by working with living donors, these matching services furnish kidneys that endure, on average, twice as long as equally compatible cadaver transplants.

Through groups like NKR, altruistic donors—people willing to donate to an anonymous person—initiate "donor chains," catalyzing multiple donations. Inspired by reading about a 60-person chain begun by such a donor, I entrusted the NKR to select my recipient. Their software churned up a highly compatible match for me more than a thousand miles away. Concurrent with receiving a kidney, my recipient's incompatible donor gave to a commensurately strong match. A courier delivered this donor's organ to a third hospital in yet another region of the country, completing the exchanges."

Perfect Strangers: kidney donation movie

I went to see Perfect Strangers last night at Stanford, by Stanford's documentary filmmaker Jan Krawitz.
It was followed by a panel discussion by Krawitz, Stanford philosopher Debra Satz, and two non-directed kidney donors, one of whom was the main character in the film. Both initiated non-directed donor chains.

The other donor was the subject of this 2011 blog post A kidney donor argues that selling kidneys should be legal.

More on the market for kidneys in Iran

Here's an article on the market for kidneys in Iran that I missed when it came out, recently pointed out to me by Mohammad Akbarpour

Kidney International (2012) 82, 627–634; doi:10.1038/ki.2012.219; published online 6 June 2012

The Iranian model of living renal transplantation

Mitra Mahdavi-Mazdeh¹

¹Iranian Tissue Bank Research & Preparation Center, Tehran University of Medical Sciences, Tehran, Iran

Correspondence: Mitra Mahdavi-Mazdeh, Iranian Tissue Bank Research & Preparation Center, Tehran University of Medical Sciences, Tehran, Iran. E-mail: mmahdavi@sina.tums.ac.ir

Received 6 March 2012; Revised 28 March 2012; Accepted 5 April 2012
Advance online publication 6 June 2012

Topof page

Abstract

Organ shortage for transplantation remains a worldwide serious problem for kidney patients with end-stage renal failure, and several countries have tried different models to address this issue. Iran has 20 years of experience with one such model that involves the active role of the government and charity foundations. Patients with a desperate demand for a kidney have given rise to a black market of brokers and other forms of organ commercialism only accessible to those with sufficient financial resources. The current Iranian model has enabled most of the Iranian kidney transplant candidates, irrespective of socioeconomic class, to have access to kidney transplantation. The Iranian government has committed a large budget through funding hospital and staff at the Ministry of Health and Medical Education by supporting the brain death donation (BDD) program or redirecting part of the budget of living unrelated renal donation (LURD) to the BDD program. It has been shown that it did not prevent the development and progression of a BDD program. However, the LURD program is characterized by several controversial procedures (e.g., confrontation of donor and recipient at the end of the evaluation procedure along with some financial interactions) that should be ethically reviewed. Operational weaknesses such as the lack of a registration system and long-term follow-up of the donors are identified as the ‘Achilles heel of the model’.

Cash for kidneys: letters to the editor of the WSJ

The recent Becker-Elias article, about which I blogged about my thoughts here, has drawn some letters to the editor, which the WSJ published under the headline Is a Market in Kidneys the Right Answer to Shortage? It is a tragedy when people die while waiting for a lifesaving transplant, but paying for organs isn't the answer.

One of them, by Sigrid Fry-Revere, doesn't fit the sub-headline. She advocates adopting something like the market approach in Iran. Her unedited letter, which she shared by email, is below:

Letter to the Editor of WSJ

Edited version ran Sat. Jan 2014

The Rest of the Story

I read with great interest Gary S. Becker and Julio Elias article “Cash for Kidneys: The Case for a Market for Organs” in Saturday’s WSJ.  Like so many others who have written on this subject, their article misrepresents the Iranian system of compensated donation.

Usually not much is said about Iran, because not much is known, but I went to Iran and spent nearly two months interviewing paid kidney donors for a documentary film I was planning. I visited six different regions and returned with over 200 transplant stories.  There are too many misconceptions about what is going on in Iran to explain in one letter, but the most important thing I would like to point out is that paid kidney donors are people, not commodities, and no matter what the economics of the situation, there is a human element that can’t be ignored.

You might think I’m going to say we should not pay kidney donors, or that I’m going to rage about how exploitive kidney selling is. Not so. I learned many things on my trip to Iran, but the most important was sometimes money is what makes helping others possible.

The issue isn’t how much a kidney is worth, but how to make helping economically feasible and how best to show appreciation. I disagree with economists who say you can put value on someone giving up part of their body to save another person’s life. A conscious, informed decision, to risk oneself for another is an invaluable gift both to the person and to society.

Iran is the only country in the world that has solved its kidney shortage, and it has done so by legalizing and regulating compensated donation.  In the rest of the world there are two options:  Altruistic donation and the black market. The third option only exists in Iran where the rule of law protects donors and recipients alike. Paid donors are not treated like criminals, as is the case when the underprivileged are exploited for their kidneys on the black market. 

The Iranian system has developed over 30 years and continues to improve.  Today, paid donors are secure in their knowledge that the system works to protect their rights as much as the rights of recipients. Their money is put in escrow, the middlemen who arrange kidney matches are NGO volunteers, not black market profiteers, and they are treated on the same medical wards and in the same post-operative clinics as kidney recipients.  

How much are Iranian kidney donors paid for their service to humanity? Much more than the thank you, travel expenses, and occasional lost wages, paid altruistic donors in the United States. Iranian kidney donors receive the equivalent to six month’s salary for a registered nurse in Iran, or approximately $32,000 in the United States. But in addition to monetary compensation, they receive many goods and services that are hard to quantify in dollars.  All receive at least one year of health insurance, not just care related to their nephrectomy, as is the case in the United States. They also receive automatic exemption from Iran’s two-year mandatory military service.

Furthermore, Kidney donors often receive extra health insurance, sometimes for their whole family and often under terms where it can be renewed annually. They receive dental care at the NGO dental clinics that serve diabetes patients and kidney recipients. They receive job services, small business loans, and household goods.  I estimate the total average package paid donors receive in Iran is close to $45,000 in value. 

Most importantly, these paid donors know the government supports them for having done something honorable, like a paid firefighter or a paid emergency medical professional. They have saved a life -- and their contribution to society is invaluable.  Mohaghegh Damad, the ethicist for the Iranian Academy of Medical Sciences told me no payment could ever be enough. But, the payment Iranian kidney donors get, makes doing the right thing easier. 

In the United States 20-30 people die every day because they can’t get a kidney. Iran is the only country in the world where almost everyone who medically qualifies to get a kidney gets one, and in many regions of the country there is a waiting list for people who want to donate.  Maybe its time we learn something from their experience.

Sigrid Fry-Revere, J.D., PhD, is a bioethicist and founder and president of the non-profit organization Stop Organ Trafficking Now and author of The Kidney Sellers (Carolina Academic Press, 2014).

Scholarships for donors and donor family members

The Isabelle Christenson Memorial Scholarship honors the life of a brave transplant recipient who died when she was only 10 years old. It is a scholarship available to anyone connected to a donor or transplant recipient:

"Scholarship Requirements: Be an organ transplant candidate, recipient, donor family member, living donor or immediate family member of a transplant candidate or recipient  "


HT: Sangram Kadam

Cash for Kidneys: The Case for a Market for Organs. Becker and Elias in the WSJ

Gary Becker and Julio Elias have a reprise of their 2007 Journal of Economic Perspectives paper in this weekend's Wall Street Journal, in a cogent column called Cash for Kidneys: The Case for a Market for Organs.

Their 2007 JEP paper was called  Introducing Incentives in the Market for Live and Cadaveric Organ Donations (slightly more direct link here).

Between then and now the number of people on the waiting list for kidneys has gone up. Their 2007 article has these sentences: "Almost 17,000 persons were waiting for a kidney transplant in 1990. But this number grew rapidly, so that about 65,000 persons were on this waiting list by the beginning of 2006."

This weekend's WSJ column starts with the sentence "In 2012, 95,000 American men, women and children were on the waiting list for new kidneys, the most commonly transplanted organ."

So, the arguments that they repeat have gotten stronger over time: the shortage of organs is costly in every sense, and could likely be relieved by allowing kidneys to be bought and sold by live donors, and allowing the purchase of organs from deceased potential donors, i.e. by repealing the part of the 1984 National Organ Transplant Act that makes such sales a felony in the United States. (Similar laws exist in most of the developed world: the only country that seems to have an explicitly legal market for kidneys is Iran, although many black and grey markets exist.)

So, why hasn't this argument made any headway, either in the U.S. or overseas? Is patient repetition of the argument the best way to make the case? I don't know the answers, but I think that the repugnance of organ sales is a subject worth studying, not just for science but also for those who might like to influence policy.

In the same issue of the JEP as Becker and Elias (2007) was my article Repugnance as a Constraint on Markets (more direct link here), which sought to understand not just the repugnance to kidney sales, but to many economic transactions, in different places and times, e.g. to charging interest on loans, or having markets for slaves or indentured servants. I noted that kidney exchange doesn't arouse the repugnance that sales do. I've since blogged about a lot of different repugnant transactions including compensation for donors (as of this writing my most recent post on transactions that some regard with repugnance is headlined Womb transplants in Sweden (where surrogacy is illegal)...)

Note that the prohibition on organ sales is not some law that remains on the books merely through inattention. This is illustrated by the recent events surrounding the tug of war over whether it might be legal to compensate (even) bone marrow donors. Briefly, the ninth circuit court of appeals issued a ruling that said that in some circumstances bone marrow donors could be compensated, but then the Department of Health and Human Services proposed regulations that would keep the ban in place.   So the opposition to organ sales--even to compensating bone marrow donors--is alive and well.

But things don't go all in one direction. Bob Slonim reminds me that while we rely on unpaid donation of whole blood in the United States, most of our supply of blood plasma comes from paid donors.

I've participated in some efforts to understand better the repugnance to compensating organ donors, e.g. here's a survey with Steve Leider about who disapproves of kidney sales, and some correlates of such disapproval:
Leider, Stephen and Alvin E. Roth, ''Kidneys for sale: Who disapproves, and why? American Journal of Transplantation  10 (May), 2010, 1221-1227.

More recently, Muriel Niederle and I conducted a different sort of survey, which assessed the relative willingness of Americans to contemplate monetary rewards for the heroism associated with kidney donation:
"Niederle, Muriel and Alvin E. Roth, “Philanthropically Funded Heroism Awards for Kidney Donors?” forthcoming in Law & Contemporary Problems, 77:3, 2014.

Judd Kessler and I have a paper forthcoming in the American Economic Review papers and proceedings (May 2014) called "Getting More Organs for Transplantation," in which we summarize the issue this way:

"Kidney sales are often the leading example of a repugnant transaction cited by those who would put stricter limits on markets in general (e.g. Sandel 2012, 2013), because of their sense that such sales arouse widespread opposition. A representative sample survey of Americans conducted by Leider and Roth (2010) suggests that disapproval of kidney sales correlates with other socially conservative attitudes, but that it does not rise to the level of disapproval of other repugnant transactions such as prostitution. In addition, there is evidence that the manner of the payment to an organ donor may mitigate some of the repugnance concerns. Niederle and Roth (forthcoming 2014) find that payments to non-directed kidney donors are deemed more acceptable when they arise as a reward for heroism and public service than when they are viewed as a payment for kidneys."

That paper closes with this thought on the presently available options: 
"While these potential donors could save thousands of additional lives, at current rates of medical need, these donors alone would not be able to supply all the demand. Consequently, we must continue working on numerous fronts to solve this growing problem. "

In summary, the issue of whether and how organ donors might be compensated is an important policy issue that also touches on an important and still poorly understood social science phenomenon. Repetition of the basic arguments may move the discussion forward as the background facts become more severe, and it's great to see the issue addressed in such a public forum as the WSJ. But it may also be that repetition of arguments is not enough. To make progress in the face of opposition, it seems likely to be useful to understand better the nature of the opposition.

Black markets and black market prices

A website call Havocscope (subtitle: Global Black Market Information) compiles information from news stories and other public sources about black markets and reported transaction prices around the world, from counterfeit goods of various sorts (from pharma to tech to food), to repugnant markets from narcotics to contract killing.

Here's their take on prices in the black markets for kidneys for transplantation.

When you click on the prices they indicate, you find their source, often a newspaper story that may only contain an anecdotal report of a transaction, so I don't think they make strong claims for the accuracy of their data, but it makes for interesting reading.

Markets for blood, milk, and sperm (new book)

Here's the announcement of a forthcoming book from Harvard University Press (by Professor Kara Swanson, whose earlier papers include The Birth of the Sperm Bank):

Banking on the Body

The Market in Blood, Milk, and Sperm in Modern America

Kara W. Swanson

Not yet available

Book Details

HARDCOVER

$35.00 • £25.95 • €31.50

ISBN 9780674281431

Publication: May 2014

Available 05/05/2014

* Academic Trade

310 pages

6-1/8 x 9-1/4 inches

10 halftones

World

Related Subjects

• MEDICAL: History
• HISTORY: United States: 20th Century
• LAW: Property
• MEDICAL: Health Policy
• SOCIAL SCIENCE: Sociology: General

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• About This Book
• About the Authors
• Table of Contents

Scientific advances and economic forces have converged to create something unthinkable for much of human history: a robust market in human body products. Every year, countless Americans supply blood, sperm, and breast milk to “banks” that store these products for later use by strangers in routine medical procedures. These exchanges entail complicated questions. Which body products are donated and which sold? Who gives and who receives? And, in the end, who profits? In this eye-opening study, Kara Swanson traces the history of body banks from the nineteenth-century experiments that discovered therapeutic uses for body products to twenty-first-century websites that facilitate a thriving global exchange.

More than a metaphor, the “bank” has shaped ongoing controversies over body products as either marketable commodities or gifts donated to help others. A physician, Dr. Bernard Fantus, proposed a “bank” in 1937 to make blood available to all patients. Yet the bank metaphor labeled blood as something to be commercially bought and sold, not communally shared. As blood banks became a fixture of medicine after World War II, American doctors made them a frontline in their war against socialized medicine. The profit-making connotations of the “bank” reinforced a market-based understanding of supply and distribution, with unexpected consequences for all body products, from human eggs to kidneys.

Ultimately, the bank metaphor straitjacketed legal codes and reinforced inequalities in medical care. By exploring its past, Banking on the Body charts the path to a more efficient and less exploitative distribution of the human body’s life-giving potential.

Here's the table of contents:

• Introduction: Banking for Love and for Money
• 1. Bankable Bodies and the Professional Donor
• 2. Banks That Take Donations
• 3. Blood Battles in the Cold War
• 4. Market Backlash
• 5. Feminine Banks and the Milk of Human Kindness
• 6. Buying Dad from the Sperm Bank
• Conclusion: Beyond the Body Bank

Forthcoming book on the Iranian kidney transplant market

Carolina Academic Press is advertising a forthcoming book,

The Kidney Sellers

A Journey of Discovery in Iran

by Sigrid Fry-Revere

Their blurb:
Rarely does an adventure story carry such social significance as in this groundbreaking ethnographic research book. Dr. Fry-Revere’s exploration of the medical ethics of compensating organ donors takes us deep inside Iranian culture to provide insight and understanding into how Iran has solved its kidney shortage. The Kidney Sellers: A Journey of Discovery in Iran addresses the question: How it is possible that in Iran there is a waiting list to be a donor, while in the United States hundreds of thousands of people have died­ for lack of a kidney?

The sale of kidneys in Iran: a report from Shiraz

A recent article, and an accompanying editorial, in the American Journal of Transplantation concern the health of kidney sellers in Iran, based on a comparison of paid donors with unpaid related living donors at the Shiraz Transplant Center in Iran.

The article is Comparison of Health Status and Quality of Life of Related Versus Paid Unrelated Living Kidney Donors  by M. K. Fallahzadeh, L. Jafari, J. Roozbeh, N. Singh2, H. Shokouh-Amiri, S. Behzadi, G. A. Rais-Jalali1, M. Salehipour, S. A. Malekhosseini1, M. M. Sagheb

Abstract
The aim of this cross-sectional study was to assess the health status and quality of life (QOL) of paid unrelated versus related living kidney donors postdonation at Shiraz Transplant Center in Iran. We invited all donors (n = 580, 347 paid unrelated, 233 related) who underwent donor nephrectomy at our center from 2004 to 2010 to participate in a health survey and physical examination. Of 580 donors, 144 consented to participate; participation of paid unrelated donors was significantly lower than related (52/347 vs. 92/233; p < 0.001). Participants underwent a complete physical examination, QOL assessment (using a 36-item short form health survey [SF-36] questionnaire) and laboratory work-up. The paid unrelated donors compared with related donors were younger (34.2 ± 7.2 vs. 40.7 ± 9.7 years, p < 0.001), had shorter time since donation (2.9 ± 1.6 vs. 3.8 ± 2 years, p = 0.004), had higher estimated GFR (72.6 ± 22 vs. 63.8 ± 15.3 mL/min/1.73 m2, p = 0.006) and had a higher percentage of patients with microalbuminuria (35% vs. 0%, p < 0.001). Additionally, general health and social functioning scores among paid unrelated donors were significantly lower (p < 0.001 and p = 0.02, respectively) than related donors. Other SF-36 scores, although lower in paid unrelated donors, did not reach statistical significance. Iranian paid unrelated donors have lower QOL and higher incidence of microalbuminuria compared with related donors.


In their concluding discussion the authors note
"To our knowledge, this is the first study comparing the health status and HRQOL of Iranian PUKDs with those of LRKDs. Our results show that Iranian PUKDs, compared with LRKDs, have poor follow-up, lower HRQOL scores and higher incidence of microalbuminuria.

One of the major drawbacks of the Iranian model of living donor kidney transplantation is the lack of long-term follow-up of LKDs [2, 3]. In our study, the rate of participation of PUKDs was significantly lower than LRKDs. Similarly, in a previous report from Iran, only 6 of 500 LKDs who were invited to participate in a health survey responded [2]. In another Iranian study, a majority (79%) of PUKDs were reported to have no regular follow-up after donation [6]. Inability to pay for follow-up visits, and insufficient knowledge of the complications of the nephrectomy and the need for regular follow-up postdonation have been suggested as the major reasons for lack of long-term follow-up among PUKDs [2, 6, 9]. Educating the LKDs, providing an extended long-term government sponsored medical insurance program beyond 1 year, and probably even payment for clinic visits could enhance their adherence with postdonation follow-up."
***************************

The accompanying editorial is Where There Is Smoke There Is Fire: The Iranian System of Paid Donation by E. J. Gordon, J. S. Gill

"Nearly 30 years after its introduction, the Iranian model remains an enigma to the Western transplant community. Established in 1988, the government-funded, compensated living unrelated kidney donor program was Iran's answer for its urgent transplantation needs. The modest fixed sum (currently about $400 US dollars) provided by the government was intended as a reward rather than as a payment for the donated kidney. The real incentive for those who have submitted to nephrectomy was a supplementary payment negotiated directly between the recipient and living donor (typically in the amount of $10 000 US dollars). Putative oversight by a not-for-profit organization maintains a buyer's market by providing a back-up donor in the event that a recipient and potential donor cannot agree on a price. The government pays for all transplant-related expenses and provides the donor with medical coverage for 1 year after the nephrectomy. It is worth noting that such depictions of the Iranian model have been contested as disingenuous by members of the Iranian transplant community [1]. Accordingly, one must interpret any analyses of the Iranian model with caution.

Predictably, critics of commercialization have opposed the program primarily out of concerns of exploitation and disrespect for human integrity [2, 3]. Aside from such opposition, the model fails to meet many of the proposed standards for a regulated system of organ sales, including nondirected donations, provisions to ensure long-term donor follow-up, and access to health care [4]. Despite the facilitation of tens of thousands of transplants, the lack of public reporting and transparency have precluded acceptance of the Iranian model as a solution to the organ shortage internationally, and have fueled questions about the integrity of the program.

The report by Fallahzadeh et al [5] in this issue of the journal provides a novel glimpse into the Iranian model. The study shares many of the limitations of other studies from Iran, including a small and selected study sample. However, their identification of a difference in microalbuminuria postnephrectomy between paid and unpaid donors fuels concerns that the clinical evaluation of donors may be compromised when donor payments are allowed. Although the absence of prenephrectomy information precludes definitive conclusions, the short time since donation suggests that abnormalities may have been present prior to nephrectomy and accordingly, that the donor clinical evaluation may not have been as thorough as necessary. The potential presence of predonation abnormalities is worth considering given the ethical ramifications. A scrupulous pretransplant evaluation and conservative approach to donor acceptance may be particularly important for paid donors who may be vulnerable to adverse health outcomes for other reasons. Subjecting paid donors to unnecessary harms without sufficient safeguards in place during the evaluation process tips the delicate risk–benefit balance against living donation.

The most plausible alternative explanation for the findings is that the proteinuria was in some way related to the higher level of poverty in the paid donors. There is limited research to suggest a link between poverty and development of proteinuria in living donors. In a cross-sectional study of living related donors from Hyderabad, India, 40% of the 50 donors studied developed microalbuminuria, and 14% developed overt proteinuria (>300 mg/day) after an average of 63 months postdonation [6]. Irrespective of the basis for the observed difference, it is not clear that the Iranian system will financially support the authors' recommendation for long-term follow-up of the individuals who developed microalbuminuria in the study.

Sadly, the risk factors for and clinical significance of proteinuria in living kidney donors remain unclear. The existing literature on this subject is hampered by use of nonstandardized definitions, a paucity of controlled studies, and virtually no information regarding progression over time. Therefore, although it is tempting to criticize the lack of organized donor follow-up in the Iranian model, to do so would be hypocritical [7]. The findings of this study therefore serve as a reminder of our collective responsibility to better understand the long-term consequences of living kidney donation.

The findings of Fallahzadeh et al [5] add to the accumulating literature that there are problems with the existing Iranian model and that the program must evolve. It is clear that the majority of paid donors are poor males, whose quality of life after nephrectomy is lower than that of the general Iranian population, and who are frequently dissatisfied with their decision to undergo nephrectomy [8]. Further, the program has been a contributing factor limiting the advancement of deceased donation and living related donation in Iran. For these reasons, a program that was once justified on the basis of need, may now be a barrier to the advancement of transplantation in Iran. How much harm to living donors' health and quality of life should Iranian transplant centers tolerate? As transplant centers are responsible for ethically sound clinical care, all potential living donors must be assured a high standard of clinical and psychosocial evaluation before the Iranian model can publicize its success.

As Fallahzadeh et al [5] point out, studies have found that few paid unrelated donors undergo follow-up care due to insufficient finances to pay for care, and donors lack knowledge about living donor complications or the need for follow-up care [9, 10]. Accordingly, transplant centers operating within the Iranian model should take extra care to optimally inform donors about the short- and long-term complications of living donation, as well as inform, encourage and enable living donors, particularly donors most at risk—paid unrelated donors—to undergo long-term follow-up care. The government's provision of health insurance to living donors for 1 year is a start toward removing some of the disincentives to donation; however, the recognition of paid donors as a particularly vulnerable group behooves the government to provide long-term follow-up care.

Anthropology celebrates Scheper-Hughes for her work on the illicit trade in organs

Dr. Nancy Scheper-Hughes Named First AAA Public Policy Award Winner

"The American Anthropological Association (AAA) is pleased to announce that its Committee on Public Policy has selected medical anthropologist Nancy Scheper-Hughes as the first recipient of the new Anthropology in Public Policy Award. Dr. Scheper- Hughes is a nationally-recognized expert on several important health issues, including hunger, illness and organ trafficking.
...
"Dr. Scheper-Hughes’ body of work and research, especially in the area of organ trafficking, has shaped how governments and international bodies address the issues of illegal transplantation.

"In 1999, Scheper-Hughes helped found the Berkeley Organs Watch Project, an organization dedicated to research on human organ traffic worldwide, including examining the transnational networks that connect patients, transplant surgeons, brokers, medical facilities and so-called “live donors.” Almost ten years later, in 2008, her investigation of an international group of organ sellers based in the East Coast of the United States and Israel led to multiple arrests by the Federal Bureau of Investigation. In recent years, she has served as an advisor or consultant to the European Union; the United Nations, Division of Law Enforcement, Organized Crime and Anti-Laundering Office on Drugs and Crime, and the Human Trafficking Office of the World Health Organization in Vienna. She has also testified as an expert before the US Congress, the Council of Europe and the British House of Lords.

Comment on the proposed federal regulation limiting bone marrow compensation

I've written earlier about the proposed regulations that would reverse the effect of the 9th circuit court of appeals decision to allow some bone marrow donors to be compensated. The opportunity to comment on the proposed regulation closed Monday at midnight Eastern time. (Here are all the comments.) Below is a comment on the proposed regulations, signed by a number of economists, myself included. Note point 2 in particular, which points out that the regulation would cut off research on the effect of incentives.

December 2, 2013

Shelley Grant, MHSA, Branch Chief,
Blood Stem Cell Transplantation Program, Division of Transplantation Healthcare Systems Bureau,  Health Resources and Services Administration 5600 Fishers Lane, Room 12C–06, Rockville, Maryland 20857


Comment on Change to the Definition of ‘‘Human Organ’’ Under Section 301 of the National Organ Transplant Act of 1984. Health Resources and Services Administration, HHS. RIN 0906–AB02.

We are academic economists who study how incentives and other mechanisms affect individual behavior and whose research is concerned with improving public welfare. We are writing in opposition to the proposed rule changes by the Department of Health and Human Services (HHS) that would ban compensation for bone marrow donations. The reasons we oppose the proposed rule change are that it ignores the most critical benefits of offering economic incentives (point 1 below) and prevents the ability to properly assess and improve the benefits of offering incentives (points 2 and 3 below) despite the HHS proposed regulation explicitly stating (Section III. Impact Analysis) “Economic and Regulatory Impact Executive Order 12866 directs agencies to assess all costs and benefits of available regulatory alternatives” (Italics added). The HHS document also states that “The provisions of this rule will not affect the following elements of family well-being: Family safety, … parental rights in the education, nurture, and supervision of their children,” and this regulation could prevent parents such as the lead plaintiff in Flynn v. Holder from obtaining bone marrow transplants for their children.1

1. The proposed regulation entirely ignores potential benefits to bone marrow recipients. The motivation for the ban focuses entirely on concerns for potential donors and gives no weight to the consideration of the patients in need of a bone marrow transplant. There are many patients whose health conditions worsen each year waiting unsuccessfully for a matched bone marrow donation. Depending on the patient's race, there is between an 8 and 50 percent chance that there will be no match in the existing registry. As a result, hundreds of patients die each year due to an
inadequate supply of donors.2 Economic incentives have the potential to motivate more bone marrow donations thereby saving and prolonging the lives of potentially thousands of patients. Indeed, the benefit-cost of adding one potential donor to the registry indicates enormous positive value, between 5 and 7 times the benefit to the cost.3 By entirely ignoring these potential benefits, the proposed regulation fails to accurately present the welfare consequences of the ban.

2. The proposed ban will prevent the most policy relevant academic research that is critically needed to determine whether and how economic incentives can be used to save lives. Alternative research methods that do not directly examine actual incentives for actual bone marrow donations (e.g., surveys), or uncontrolled studies that do not appropriately account for confounding factors (i.e., differences in incentivized and non-incentivized populations), will produce unreliable policy evidence. Recent work, consisting mainly of Randomized Controlled Studies (RCTs) examining economic incentives to motivate blood donations, shows positive results when evaluating actual incentives for actual blood donations in natural contexts. This robust evidence contrasts with earlier results using alternative methods not examining actual incentives and donations.4 This is not just an academic point; empirical evidence obtained with rigorous methods should be used to inform policy. This rigor should apply in general, but it is especially critical in the context of bone marrow donations where thousands of lives are at stake every year and where adopting a ban without appropriate evidence could have disastrous  consequences.

3. The ban will eliminate the opportunity to offer any form of economic incentive, not just cash payments. The policy would thus prevent even non-cash rewards that have been shown to significantly increase blood donations with no harm to the quality of the blood supply.5 The proposed change will thus prevent many potential types and sizes of incentives that could be effective. Appropriately designed research could shed light on whether different types of incentives and incentive amounts would have different effects on donations, but the proposed regulation would make this type of research illegal.

In addition to inappropriately assessing the cost-benefit analyses, we oppose the ban for the
following two reasons. First, allowing for the compensation of bone marrow donors does not mean
that donors have to accept the compensation. When offered, donors could still choose to not accept the incentive or could even donate it to charity. Second, donating bone marrow through the
apheresis process and donating whole blood or plasma share a critical characteristic: donors
provide renewable material that is extracted with minimal risk and that their body regenerates
quickly. The US government has never prevented compensation for these other blood products despite deliberations,6 thus from this renewable material perspective there is no reason to have different policies for these types of donations.

In summary, the proposed regulation ignores the potential beneficial effects that offering compensation to bone marrow donations will have on the well-being of patients who need a transplant but are unable to find a match in an uncompensated-only donation system. This implies that “all costs and benefits of available regulatory alternatives” have not been assessed. Moreover, it makes it illegal to conduct the very research that would be critically necessary to establish the effects that incentives can have on donations. For these reasons, we oppose this regulation proposed by HHS that would ban all forms of compensating bone marrow donors.

Signed,
Theodore Bergstrom, University of California at S. Barbara Stefano DellaVigna, University of
California at Berkeley Julio J. Elias, Universidad del CEMA, Argentina
Rodney Garratt, University of California at S. Barbara
Michael Gibbs, University of Chicago Judd Kessler, University of Pennsylvania Nicola Lacetera,
University of Toronto Stephen Leider, University of Michigan John List, University of Chicago
Mario Macis, Johns Hopkins University
Daniel McFadden, University of California at Berkeley Matthew Rabin, University of California at
Berkeley Alvin Roth, Stanford University
Damien Sheehan-Connor, Wesleyan University
Robert Slonim, University of Sydney
Alex Tabarrok, George Mason University



Footnotes:
1 The lead plaintiff, Doreen Flynn, has three daughters afflicted with Fanconi anemia who may need
multiple bone marrow transplants during their teen years.
2 Bergstrom, Garratt, and Sheehan-Connor 2009, Tables 2 and 4.
3 Ibid, Table 7.
4 Lacetera, Macis and Slonim 2013.
5 Ibid.
6 Starr, 1998.


References
Bergstrom, T., Garratt, R., Sheehan-Connor, D. 2009. One chance in a million: altruism and the bone marrow registry. American Economic Review 99, 1309–1334.
Lacetera, N., Macis, M., Slonim, R. 2013. Economic rewards to motivate blood donations. Science 340: 6135, 927–928.
Starr, D. 1998. Blood: An epic history of medicine and commerce. Imperial College, London.

Compensation for donors: it's not just kidneys

I'll be speaking later this year about deceased donation at a conference of the International Society for Heart & Lung Transplantation. When I went to their website to arrange some hotel details, I saw this announcement about the Society's position that "the sale of organs from both live and deceased donors is unethical and violates the Universal Declaration of Human Rights."

NEW: ISHLT Position on the Trafficking of Donor Organs
"Tales from the Organ Trade” and similar documentaries are reminders that organ trafficking remains an important international problem. In line with the previously stated ISHLT position and in concert with other national and international transplantation societies, the ISHLT strongly and emphatically endorses the Declaration of Istanbul which seeks to abolish the illegal and immoral trade in donor organs which is supported in part by so called “transplant tourism”. As a corollary of which,  the Society values and supports every effort to improve the availability of donor organs by legitimate process thereby providing community access to these life sustaining therapies.


They link to their 2007 position statement, reproduced here:

International Society for Heart and Lung Transplantation
Statement on Transplant Ethics
Approved April 2007

Thoracic organ transplantation improves the length and quality of life of patients with severe
heart or lung disease. It is a societal endeavour bound by ethical principles. The donation of
organs from a deceased patient must always be made freely and without coercion. The gift
of an organ by a live donor, such as a pulmonary lobe transplant, must be made in the same
fashion and with informed consent. To ensure that these principles are adhered to, the
transplant process must be transparent, legally regulated and open to both national and
international scrutiny.

The ISHLT endorses the view of the World Medical Association that the sale of organs from
both live and deceased donors is unethical and violates the Universal Declaration of Human
Rights.

Obtaining organs for transplantation from the bodies of executed prisoners contravenes the
principle of voluntary donation. A condemned prisoner and his relatives cannot consent
freely. Furthermore, such practices provide a perverse incentive to increase the number of
executions and it lays the judicial process open to corruption.

ISHLT members should discourage patients from seeking transplantation in countries where
transplantation is not open to external scrutiny and the ethical standards of the ISHLT
cannot be assured, regardless of whether payment for organs is involved. ISHLT members
should work with their own governments to ensure that such ‘transplant tourism’ that
contravenes these ethical principles is made illegal.

Members of the ISHLT should not participate in or support the transplantation of organs
from prisoners or the sale of organs for transplantation. Any ISHLT member who has been
found to have contravened this ethical principle may have their rights and privileges as a
member suspended or removed by the ISHLT Board.

Individuals submitting data about clinical transplantation, or the use of human tissue, for
presentation at any of the ISHLT’s meetings, to the Society’s Registry or for publication in
the Journal of Heart and Lung Transplantation will be asked to sign a personal statement
confirming that the principles of both the Declaration of Helsinki formulated by the World
Medical Association and of this ethical statement by the ISHLT have been adhered to.

References
Rothman DJ, Rose E, Awaya T, Cohen B, Daar A, Dzemeshkevich SL, Lee CJ, Munro R,
Reyes H, Rothman SM, Schoen KF, Scheper-Hughes N, Shapira Z, Smit H. The Bellagio Task
Force report on transplantation, bodily integrity, and the International Traffic in Organs.
Transplant Proceedings 1997; 29: 2739-45. Also available at the International Committee of
the Red Cross web-site:
http://www.icrc.org/Web/Eng/siteeng0.nsf/iwpList302/87DC95FCA3C3D63EC1256B66005B3
F6C (accessed 1st May 2007)
Declaration of Helsinki. http://www.wma.net/e/policy/pdf/17c.pdf (accessed 1st May 2007)

An investigative journalist at the Telegraph is offered a kidney for sale

Britons being sold illegal kidneys for surgery in Sri Lanka
Patients awaiting kidney transplants in the UK are being offered illegal organs which are then used in operations at a Ski Lankan hospital

More on the law and politics of compensating bone marrow donors

The legal battle is shaping up over the decision of the department of Health and Human Services to circumvent the decision of the ninth circuit court of appeals that it is legal to compensate bone marrow donors.  The Institute for Justice, which was a successful litigant in the court ruling, has outlined their current thoughts here:
Federal Officials Move to Block Life-Saving Research
HHS’ Proposed Rules Would Undo Court Ruling Legalizing Bone Marrow Compensation

They say in part:
"The proposed regulation would ban marrow compensation just when empirical research has begun into the effects of compensating donors.  A team of economists—Nicola Lacetera of the University of Toronto, Mario Macis of Johns Hopkins University, and Robert Slonim of the University of Sydney—were in the process of finalizing a research proposal that would have investigated the effects of donor compensation when they learned of the new rule.

“These new regulations make it impossible for researchers to obtain the necessary evidence to inform policy.  Our proposed studies would be made illegal by these new provisions,” explained Macis, who, along with Lacetera and Slonim, has published some of the leading work showing that economic incentives can be effectively used to increase blood donations without affecting blood supply safety.  “Properly designed compensation for bone marrow donors could similarly lead to significant increases in donations, thus giving potentially hundreds or thousands of people in need of a transplant every year a greater chance of survival.  At a minimum, the federal government should not make it illegal for researchers to find out whether incentives can help address the shortage of bone marrow donors.”

“I don’t think that anybody should go to jail just for trying to save somebody’s life,” added Doreen Flynn, who has three children with Fanconi anemia, a blood disease that frequently requires a bone marrow transplant and who was the lead plaintiff in the original lawsuit.  “If paying donors results in more marrow donations, we should pay them.  And it shouldn’t be a crime to investigate it.”
“We know what doesn’t work,” said Robert McNamara, also a senior attorney with the Institute and co-lead counsel in the case.  “We have 30 years of experience with an altruism-only marrow-donor program, and we know that has not succeeded in recruiting enough donors.  The only question is whether offering compensation can achieve better results.  We will not allow the federal government to make it a felony to find out the answer.  Hopefully, we will do that by persuading the government not to adopt this rule, but if we have to, we will sue them again.  And we will win—again.”

The proposed regulation is currently open for a period of public comment through December 2, 2013.  Individuals who have been impacted by blood-borne cancer or bone marrow donations are encouraged to leave comments on the Department of Health and Human Services’ website:  http://www.regulations.gov/#!submitComment;D=HRSA_FRDOC_0001-0115."
****************

You can follow some of the story in my earlier posts on bone marrow and compensation.

Financial Incentives for Living Kidney Donation: Ethics and Evidence

That's the title of a recent letter by Matthew B. Allen and Peter P. Reese at Penn, motivated by an article suggesting that payment to donors could be welfare improving,

1. Barnieh L, 
2. Gill JS, 
3. Klarenbach S, 
4. Manns BJ

: The cost-effectiveness of using payment to increase living donor kidneys for transplantation. Clin J Am Soc Nephrol   2013

Allen and Reese (may be gated) review arguments pro and con, and conclude:

Given the promise of a cost-effective strategy provided by Barnieh’s group—and a lack of empirical evidence that ethical concerns about incentivizing live donors would manifest—we propose a research agenda and necessary elements for a limited trial of incentives. First, using modeling, researchers should examine the comparative effectiveness of different incentive strategies, such as reimbursement for lost wages and expenses or provision of insurance. Expense reimbursement is a promising alternative to fixed payment. Estimates of donor financial burden range from $907 to $3089, and compensation would help ensure that donors do not suffer financially from donation (8). Because potential donors would not stand to benefit financially, expense reimbursement could ease concerns about undue and unjust inducement, but it might also fail to generate a meaningful increase in the supply of organs (5). Moreover, in contrast with fixed payment for donation, expense reimbursement is legal in the United States (1).

Second, a limited, real-world trial of regulated incentives should be conducted. Ideally, the effect of a direct payment intervention could be contrasted with expense reimbursement and usual care. A geographically limited trial should assess (1) the effect of different payment models on the number of donors (to assess the program’s benefits), (2) the socioeconomic and general health status of potential and actual donors (to assess unjust inducement), and (3) donor comprehension of risks and evidence of donor coercion (to assess undue inducement). If incentives are provided for only a subset of donors, evidence of crowding out should also be assessed. The trial should measure psychological, financial, and physical outcomes after donation. Existing protections for potential live donors will be necessary, such as use of independent donor advocates, separation of donor and recipient evaluation teams, and ability to opt-out from donation with dignity at any time (5). Additional protections may also be needed, such as a “cooling off” period between evaluation and donation to allow transplant teams multiple opportunities to assess donor motives and comprehension.

The barriers to conducting such a trial are significant. In the United States, these barriers include the National Organ Transplant Act (1). Removing the legal prohibition on payment for donation would require persistent advocacy by diverse stakeholders. So far, surveys suggest a lack of consensus for organ markets among the general public, and a minority of transplant surgeons support paying for living donation (9,10).

Current trends regarding the use of financial incentives in medicine suggest that the time is ripe for new consideration of payments for living kidney donation. The last decade has witnessed rising interest in behavioral economics and well-designed clinical trials using financial incentives to change diverse health behaviors, including smoking and weight loss (11–13). In the meantime, this work by Barnieh et al. may allow advocates to make a financial case for incentives in the realm of living kidney donation. Reassurance about the ethical concerns, however, can come only through empirical evidence from actual experience.

Nalini Ambady, RIP

Stanford psychology professor Nalini Ambady passed away after a long search for a matching bone marrow donor:
Nalini Ambady, Stanford psychology professor, dies at 54
"A distinguished social psychologist, Ambady was well known for her research that showed that people can form accurate first impressions about others based only on seconds-long observations of their nonverbal behavior."

"Nalini Ambady, a Stanford professor of psychology, died Oct. 28 after a long battle with leukemia. Her passing followed a yearlong, worldwide effort by family, friends and students to find a bone marrow donor match."
**************

Professor Ambady's students and friends organized an active campaign to help her find a bone marrow donor, which you can follow here: http://ambadylab.stanford.edu/helpnalininow/

Here's a story from New Delhi TV (NDTV) that in passing emphasizes how the inability to compensate donors can make the search tragically difficult (emphasis added): Professor Nalini Ambady's death highlights lack of awareness on bone marrow transplants in India

"Because of genetic markers, a person is likely to find a match from one's own ethnic gene pool. In Ms Ambady's case her match would most likely have been from someone from her birthplace - Kerala.

"For the past six months, the Ambady family has been carrying out drives in India to encourage people to sign up for the bone marrow registry in the hopes of finding her a potential match.

"But in a country of 1.2 billion, only about 45,000 people have signed up to be bone-marrow donors. In comparison, there are over 10 million donors on the United States' National Marrow Donor Program.

"This is despite the fact that becoming a bone marrow donor is simple. All it takes is a swab test-rubbing an ear bud on the inside of one's cheek. An actual transplant is as painless as donating blood. Still, because of ignorance, lack of awareness, cultural taboos or psychological fears Indian's don't sign up to become donors.

"Ms Ambady found at least six potential matches from India. But they all dropped out. According to a childhood friend Ann Ninan, "It was heart breaking for the family."

"Ms Ambadi's family will not be able to celebrate this Diwali with her but during this festive season let's all sign up as donors. It's a few minutes of your time but it could save someone's life."
***************

My colleague Muriel Niederle, who took a class from Professor Ambady at Harvard, reflects on her passing here.

See some of my other posts on bone marrow donation, and the ongoing political/legislative/legal disputes concerning whether bone marrow donors can be compensated, or whether this should be forbidden as a repugnant transaction. (Long story short: The conventional interpretation that paying bone marrow donors was outlawed by the National Organ Transplant Act was upset by a decision of the 9th Circuit Court of Appeals, but the Department of Health and Human Services is taking steps to change the relevant regulations so that it will continue to be illegal despite the court ruling.)

The law and politics of bone marrow and compensation for donors

The Department of Health and Human Services is proposing new regulations that would put bone marrow more clearly into the class of organs for which payment is forbidden by the National Organ Transplant Act of 1984. This is in response to the decision by the Ninth Circuit to make compensation legal for bone marrow donations made through the harvesting of blood stem cells directly from the blood.

Here's the relevant page from the Federal Register: Federal Register/ Vol. 78, No. 191 / Wednesday, October 2, 2013 / Proposed Rules

Here are my earlier posts on the courts and compensation for bone marrow donation.

Since I'm not licensed to practice law in North Carolina or anywhere else, I wrote to Kim Krawiec to ask whether HHS could simply overrule the Ninth Circuit with a regulation, or whether Congress would have to get involved.

Here is Kim's reply:
"... new legislation is probably not needed to overturn the 9th circuit ruling -- that is certainly the position of HHS.  Here is the relevant language from NOTA (with emphasis mine): (1) The term “human organ” means the human (including fetal) kidney, liver, heart, lung, pancreas, bone marrow, cornea, eye, bone, and skin or any subpart thereof and any other human organ (or any subpart thereof, including that derived from a fetus) specified by the Secretary of Health and Human Services by regulation.  

The only question would be whether HHS exceeded its authority in some way through this change. I'm sorry to say that such a claim would be an uphill battle.  One might imagine, for example, a claim that the statute only permits the addition of "organs" and HSCs drawn from peripheral blood are not an organ (as the 9th Circuit concluded).  But courts are extremely deferential to agencies on these questions of interpretation (the term is "Chevron deference", named after a Supreme Court case establishing the standard). Courts are very reluctant to overturn agency interpretations of this sort and defer to the agency interpretation unless it is unreasonable.  Hopefully the interpretation (assuming the proposed reg is enacted) will be challenged, but I think this one will be a tougher fight than the first case."

HT: Bob Slonim

Surrogacy is big business in India

The BBC has a story: Living inside the house of surrogates

"Commercial surrogacy is estimated to be worth more than $1bn a year in India. While pregnant, some surrogate mothers live in dormitories - which critics call baby factories. They give childless couples the family they have longed for, but what is it like for the women who carry someone else's child for money?"

Why it's hard to reimburse non-directed kidney donors for their travel costs

A letter to the editor of the American Journal of Transplantation:

To the Editor:

We are responding to the Melcher et al. [1] article, which recommends that the National Living Donor Assistance Center (NLDAC) pay for travel and lodging for nondirected donors (NDDs). We commend the work done by this group of stakeholders and believe the publishing of their findings is vital to improving the process of kidney paired donation. We do, however, need to clarify one point in their many important recommendations.

The article recommends “The National Living Donor Assistance Center should provide travel and lodging expenses to the NDD.” It is important to note that there are limits to the NLDAC program that were put in place by the U.S. Congress. NLDAC cannot pay for the travel and lodging expenses for all NDDs. The Organ Donation Recovery and Improvement Act (ODRIA) [2] established the legislative parameters for NLDAC. ODRIA states that individuals may not receive compensation from the grant if these expenses can reasonably be paid by a State or Federal program, an insurance company or the recipient of the organ. ODRIA requires means testing of the recipient's household income.

In practice, this means a recipient must be identified before an application can be filed with NLDAC. Because NDDs do not have a recipient identified before their evaluation trip to transplant center, NLDAC cannot reimburse those expenses. However, after a recipient is identified, a NLDAC application may then be filed. It should be noted that NLDAC received 42 applications between 2008 and 2012 for NDD, of which 32 were approved, providing NDDs with reimbursement of travel expenses through NLDAC.

If the recipient's household income is below the income threshold of 300% of the HHS Poverty Guidelines, NLDAC is allowed to reimburse those donor's expenses for the surgery and medical follow-up trips. If the recipient's income is above the income threshold, NLDAC may reimburse the donor's expenses if financial hardship is proven by the recipient. If the application is not approved, the National Organ Transplant Act (NOTA) [3] allows the recipient to reimburse the donor's expenses.

Lastly, we agree with the article's recommendation that payers should cover donor travel and lodging costs given that, by donating and traveling, the donor is enabling not only the recipient's transplant, but also those of other recipients.

This letter represents the views of the authors and does not necessarily represent the views of the grant funder.

A. O. Ojo1*, R. M. Merion2, D. H. Howard3 and P. H. Warren4
1Division of Nephrology, Department of Internal Medicine, University of Michigan, Ann Arbor, Michigan
2Division of Transplantation, Department of Surgery, University of Michigan, Ann Arbor, Michigan
3Department of Health Policy and Management, Emory University, Atlanta, Georgia
4National Living Donor Assistance Center, American Society of Transplant Surgeons, Arlington, Virginia
*Corresponding author: Akinlolu Ojo, aojo@med.umich.edu
 The letter is found under the heading
Response to “Dynamic Challenges Inhibiting Optimal Adoption of Kidney Paired Donation: Findings of a Consensus Conference” by Melcher et al.
American Journal of Transplantation, Volume 13, Issue 8, page 2228, August 2013