Approaches to alleviating the shortage of transplant organs: AAAS annual meeting

Weather permitting, I'll be on my way to Chicago today for a session at the AAAS meeting, on the shortage of organs for transplants.

Transplant Organ Shortage: Informing National Policies using Management Sciences

Friday, 14 February 2014: 10:00 AM-11:30 AM

Columbus IJ (Hyatt Regency Chicago)

Since the first successful kidney transplant in 1954, outcomes have improved dramatically.  As a result,  the wait list for organ transplants has grown significantly over time. With only about 17,000  kidneys available from combined living and deceased donors annually, there are currently 99,000 Americans waiting for a kidney transplant, and the wait-list mortality is now higher than ever before. National policies for organ allocation are largely dictated by legislative priorities, but the organ shortage results in a number of disparities and therefore,  there is a growing interest in optimizing organ allocation policies to develop a balance between fairness, utility and efficiency.

Organs are a limited, perishable resource and using them more effectively saves more lives. The speakers in this briefing have taken an inter-disciplinary approach to addressing the organ allocation in the U.S., suggesting compelling and provocative solutions. Michael Abecassis, a transplant surgeon and Chief of the Transplant Program at Northwestern University’s Feinberg School of Medicine, and Past President of the American Society of Transplant Surgeons will offer a brief overview of the current issues facing organ allocation. John Friedewald, a transplant nephrologist and  Past Chair of the United Network for Organ Sharing Kidney and Pancreas Committee, that oversaw the most recent proposed changes in kidney allocation, also from Northwestern University’s Feinberg School of Medicine, will speak about the implications of these recent proposed changes to deceased donor kidney allocation policy. Nobel laureate (2012) and Stanford University economist Alvin Roth will discuss the evolution of innovative solutions to the organ shortage and how mathematical models are used to optimize Kidney Paired Donation and the impact of increasing living donor kidney transplants on the waiting list for deceased donor transplants. Sanjay Mehrotra from the McCormick School of Engineering at Northwestern University will discuss how simulation models can be used to optimize deceased donor kidney utilization to maximize utility.  Mark Siegler Director of the University of Chicago’s MacLean Center for Clinical Medical Ethics and executive director of the Bucksbaum Institute for Clinical Excellence will  will challenge some long-held beliefs about living donors and will address the salient issues related to ethical considerations in potential solutions to the organ shortage..

Michael Abecassis MD MBA, J. Roscoe Miller Distinguished Professor of Surgery and Microbiology/Immunology, Chief, Division of Transplantaiton, and Founding Director, Comprehensive Transplant Center Northwestern University Feinberg School of Medicine

Organizer

John Friedewald MD, Associate Professor of Medicine and Surgery, Comprehensive Transplant Center, Northwestern University Feinberg School of Medicine, and former chair, Organ Procurement and Transplantation Network/United Network for Organ Sharing Kidney Transplantation Committee

Discussant

Sanjay Mehrotra PhD, Professor, Department of Industrial Engineering and Management Sciences, Northwestern University McCormick School of Engineering, and Director, Center for Engineering and Health, Institute for Public Health and Medicine, Northwestern University Feinberg School of Medicine

Addressing Allocation Inefficiencies and Geographic Disparities

Alvin Roth PhD, Craig and Susan McCaw Professor of Economics, Stanford University, and co-recipient of the 2012 Nobel Prize in Economic Sciences

Allocating Donor Organs in Ways that Increase Their Availability

Mark Siegler MD, Lindy Bergman Distinguished Service Professor of Medicine and Surgery, University of Chicago Medicine, Founding Director of the MacLean Center for Clinical Medical Ethics and Executive Director of the Bucksbaum Institute for Clinical Excellence

Ethical Considerations for Innovative Strategies to Increase the Supply of Organs
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Update: here's a picture of the panel:

and here's a news story: Math saving lives: New models help address kidney organ donation shortages

Counterproductive incentives in transplantation

Which would be better, to have a transplant center transplant 200 patients and have 150 do well, or to have the center transplant 100 patients and have all of them do well? How about if the 100 patients who didn't receive a transplant in the second scenario would all have died?

In Oregon, The Bend Bulletin has a three part series (pointed out to me by Ben Hippen) on the difficulties of regulating transplant centers, and the sometimes counterproductive incentives that are introduced (in an effort to counteract other bad incentives that hospitals may have).

UPMC, the University of Pittsburgh Medical Center, comes out looking very good, incidentally.


Patients denied transplants as donor organs are discarded
PART 1: Centers forced to focus on benchmarks rather than patients
By Markian Hawryluk

"Patients who need organ transplants are dying even while viable organs are being thrown out, as government regulations have forced transplant centers to focus on overall survival rates instead of the well-being of individual patients.

"The rules implemented by the Medicare program, which pays for the vast majority of organ transplants in the U.S., evaluate transplant centers based on the one-year patient and organ survival rates after transplant. Centers that fall below benchmarks could be shut down or forced into a lengthy and expensive remedial process.

That has prompted many centers to choose healthier patients and higher quality organs to transplant. High-risk patients that could pull down a center’s overall survival rate are often unable to get on the transplant list, or end up dying on the waiting list as centers pass on marginal but still usable kidneys, livers and lungs. And the decades-long growth in the number of transplants performed in the U.S. has plateaued since the regulations were implemented.

“The side effect has been to turn people risk averse,” said Dr. Dorry Segev, a transplant surgeon at Johns Hopkins Medical Center, “to the point where patients who would benefit from transplant are being denied transplants, and to the point where organs that are beneficial to patients are discarded.”

The regulations have caused centers to take a hard look at their quality-improvement mechanisms and how they evaluate patients and organs for transplant.

Programs became acutely aware of their survival rates, which began to climb after the rules went in effect in 2007.

The percentage of hearts still beating one year after transplant hit an all-time high of 91 percent in 2010, up from 88 percent in 2003; 85 percent of transplant lungs were still breathing, up from 80 percent in 2003. Deceased donor kidney transplants have achieved an astonishing 93 percent success rate.

"Transplant surgeons routinely credit the regulations with strengthening the transplant system and for the most part, improving the quality of care for transplant patients.

“There is no question we have a healthier system and a more monitored system than we did before these regs came out,” said Dr. Michael Abecassis, director of the transplant center at Northwestern University in Chicago.

The unintended consequence, he said, is that centers are “cherry-picking” their patients.

“Patients might die and not get transplanted even though they may have an 80 percent chance of survival,” Abecassis said. “If the target is 90 percent, or you’re going to get flagged, you may look at 80 and say, ‘I’m not going to do that.’ Well, if you’re the patient, it’s 80 versus zero. Then 80 is pretty good.”

 ...
"Before the regulations went into effect, the number of transplants in the U.S. had grown each year. But in 2007, the first year centers were being held to the survival benchmarks, the number of transplants dropped and has remained flat ever since."
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Transplant centers pull back to avoid sanctions
PART 2: High-risk patients can put programs in jeopardy

"The new regulations, known as the Medicare Conditions of Participation, or COPs, were finalized in 2005 after a series of highly public transplant scandals. Reports of wait-list irregularities, diversions of organs and major medical errors spurred CMS officials to step in and establish regulations for what primarily had been a self-regulated field.

"CMS, the largest purchaser of transplants in the world (with the possible exception of China), adopted metrics originally developed by the transplant industry itself. Years earlier, the United Network for Organ Sharing’s Organ Procurement and Transplant Network had set up a flagging system to help identify and improve programs with subpar results.

But while that flagging system relied on peer review and public disclosure, the CMS regulations threaten to shut down centers that don’t improve.

Centers whose number of patient deaths or organ failures exceed 150 percent of what would be expected for their mix of patients are flagged. Multiple flags within a 21⁄2-year period trigger CMS action.

Centers then have 210 days in which to explain the mitigating factors that led to their low survival rates. If programs can improve by the end of that period, they are allowed to continue operating as usual. In other cases, CMS will acknowledge the mitigating circumstances and grant exceptions.

The centers that can’t improve quickly or convince CMS to grant an exception are given three options: shut down voluntarily, shut down involuntarily, or enter into a systems improvement agreement, or SIA. Through August 2012, 127 of the nation’s 330 transplant centers were flagged twice and investigated by CMS, including the programs at Hopkins.

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Transplantable organs go to waste
PART 3: Centers feel regulatory pressure to avoid non-ideal organs

"Transplant programs may have to make do with more marginal organs going forward. Ideal organs generally come from young, healthy individuals who incur a traumatic death. Those types of donors are becoming less common, due to gains in highway safety and medical advances that can save accident victims from brain death. A Canadian study released in October found that the percentage of patients with brain injuries who eventually were declared brain dead fell from a high of 9.6 percent in 2004, to 2.2 percent in 2010.

"Donations after brain death accounts for half of kidney transplants, three-quarters of liver transplants, 90 percent of lungs, and all hearts. But that is changing.

"An increasing proportion of organs are coming from patients whose hearts stopped beating before the other organs could be recovered, or from older, sicker donors. Both categories of organs have a lower chance of surviving one year after transplant.

“We are seeing more and more organs sitting in that category of marginal organs,” Alexander said.

"Expanded-criteria donor kidneys (ECD), for example, have an 82 percent one-year survival rate, compared with 90 percent for a standard-criteria kidney. A kidney procured from a brain-dead donor has a 91 percent one-year survival rate, while those recovered from donors after cardiac death (DCD) have an 89 percent rate.

"When patients are listed for transplant, they are usually presented with a menu of organ types, each with different risk profiles, and asked to choose what types of organs they would accept. When organs become available, doctors and transplant coordinators decide whether they are willing to transplant that organ into that patient and whether to pass on that offer to the patient.

"Studies show that in aggregate, transplant candidates who accept ECD kidneys do better over the long run than patients who wait on dialysis for a more ideal kidney. While standard kidneys last an average of 10 years post-transplant, ECD kidneys average five.
...
"Yet marginal and high-risk organs are routinely turned down. An analysis of organ sharing data by surgeons at the University of California, San Francisco, found that 84 percent of patients who died waiting for a liver had received at least one organ offer and an average of six offers. Most were declined by the surgeons due to donor age or quality of organ.

“Wait-list deaths are not simply due to lack of donor organs as many of us assume,” lead author Dr. John Roberts said, citing the stigma of non-ideal livers.

"When surgeons become more selective about marginal organs, it can quickly result in a snowball effect. When an organ becomes available it is offered electronically to centers in the region and across the country. The more centers decline an organ, the more surgeons with patients lower down the list begin to wonder why the organ has been passed on so many times. And with each refusal, the time the organ sits on ice and degrades in quality increases. Kidneys can still be transplanted up to 48 hours after being put on ice, livers less than a day. If no center is willing to take a chance, eventually the organ is simply thrown out.

“Our system is pretty slow,” Roberts said. “It works well for good organs. It doesn’t work that well to get not-so-good organs broadly distributed.”

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.

Organ donor registration in Israel

Judd Kessler and I just got this email from Jacob Lavee (about whom I've written before), with good news that he kindly gave me permission to post:

Dear Al and Judd,

Just a short note to let you know that the Israeli Minister of Health has adopted this week my recommendation to establish by law the modified mandated choice model based upon your work, whereby the issuing or renewal of an ID, passport or driving license will be conditional upon answering the question of becoming a registered donor to which only a positive answer will be given as an option or else the “Continue” button will be selected. It seems that, contrary to my previous worries, the entire registration for these documents is currently being done online and therefore there should be no technical issues to implement this model.

Thank you guys for providing the proof of concept which I cited to the ministerial committee.

This model will be added upon the prioritization model, which is already implemented by law.

Jay
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The work Jay is referring to is a paper, currently out for review at a journal that doesn't like prepublication on the web, "Don’t Take ‘No’ For An Answer: An experiment with actual organ donor registrations," which finds, in a study of the online MA state organ donor registry, that requiring potential donors to choose either "yes" or "no" when asked if they wish to be on the donor registry does not increase registrations, and seems likely to reduce the rate of donations by next of kin when the deceased is unregistered.

Womb transplants in Sweden (where surrogacy is illegal)

The NY Times has the story: Swedish Doctors Transplant Wombs Into 9 Women

 "STOCKHOLM — Nine women in Sweden have successfully received transplanted wombs donated from relatives in an experimental procedure that has raised some ethical concerns. The women will soon try to become pregnant with their new wombs, the doctor in charge of the pioneering project has revealed.

"The women were born without a uterus or had it removed because of cervical cancer. Most are in their 30s and are part of the first major experiment to test whether it's possible to transplant wombs into women so they can give birth to their own children.

"In many European countries, including Sweden, using a surrogate to carry a pregnancy isn't allowed.
...
"Some experts have raised concerns about whether it's ethical to use live donors for an experimental procedure that doesn't save lives. But John Harris, a bioethics expert at the University of Manchester, didn't see a problem with that as long as donors are fully informed. He said donating kidneys isn't necessarily life-saving, yet is widely promoted.

"Dialysis is available, but we have come to accept and to even encourage people to take risks to donate a kidney," he said.

"Brannstrom said the nine womb recipients are doing well. Many already had their periods six weeks after the transplants, an early sign that the wombs are healthy and functioning.
...
"None of the women who donated or received wombs has been identified. The transplants began in September 2012 and the donors include mothers and other relatives of the recipients.
...
"The transplant operations did not connect the women's uteruses to their fallopian tubes, so they are unable to get pregnant naturally. But all who received a womb have their own ovaries and can make eggs. Before the operation, they had some removed to create embryos through in-vitro fertilization. The embryos were then frozen and doctors plan to transfer them into the new wombs, allowing the women to carry their own biological children.
...
""If this had been possible when I was younger, no doubt I would have been interested," she said. Gimre, who has two foster children, said the only option for women like her to have biological children is via surrogacy, which is illegal in many European countries, including Norway and Sweden.
...
"The technique used in Sweden, using live donors, is somewhat controversial. In Britain, doctors are also planning to perform uterus transplants, but will only use wombs from dying or dead people. That was also the case in Turkey. Last year, Turkish doctors announced their patient got pregnant but the pregnancy failed after two months.

"Mats has done something amazing and we understand completely why he has taken this route, but we are wary of that approach," said Dr. Richard Smith, head of the U.K. charity Womb Transplant UK, which is trying to raise 500,000 pounds ($823,000) to carry out five operations in Britain.

"He said removing a womb for donation is like a radical hysterectomy but it requires taking a bigger chunk of the surrounding blood vessels to ensure adequate blood flow, raising the risk of complications for the donor. Smith said British officials don't consider it ethical to let donors take such chances for an operation that isn't considered life-saving.
...
"Doctors in Saudi Arabia performed the first womb transplant in 2000, using a live donor, but it had to be removed after three months because of a blood clot."

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."
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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.
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"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.