Showing posts with label kidneys. Show all posts
Showing posts with label kidneys. Show all posts

Saturday, March 1, 2025

Kidney transplant black market in Myanmar

 BBC Burma has the story (I guess they haven't updated their country name...no doubt they still refer to the Gulf of Mexico, too:) 

The story is about Burmese people purchasing a kidney from other Burmese people, after which they both travel to India for the surgeries, which involves pretending to be relatives.

Myanmar villagers reveal 'desperate' illegal kidney sales, BBC Burmese 

"Zeya, whose name has been changed to conceal his identity, knew of local people who had sold one of their kidneys. "They looked healthy to me," he says. So he started asking around.

"He is one of eight people in the area who told BBC Burmese they had sold a kidney by travelling to India.

...

"Buying or selling human organs is illegal in both Myanmar and India, but Zeya says he soon found a man he describes as a "broker".

"He says the man arranged medical tests and, a few weeks later, told him a potential recipient - a Burmese woman - had been found, and that both of them could travel to India for the surgery.

"In India, if the donor and recipient are not close relatives, they must demonstrate that the motive is altruistic and explain the relationship between them.

...

"He says the broker made it appear as if he was donating to someone he was related to by marriage: "Someone who is not a blood relative, but a distant relative".

...

Zeya says he was told he would receive 7.5m Myanmar kyats. This has been worth somewhere between $1,700 and $2,700 over the past couple of years

...

" he flew to northern India for the operation and it took place in a large hospital. ... he stayed in hospital for a week afterwards.

...

"The BBC last heard from Zeya several months after his surgery.

"I was able to settle my debts and bought a plot of land," he said.

But he said he couldn't afford to build a house and had not been able to construct one while recovering from the surgery. He said he had been suffering from back pain.

"I have to restart working soon. If the side effects strike again, I have to deal with it. I have no regrets about it," he added.

He said he stayed in touch with the recipient for a while, and she had told him she was in good health with his kidney.

Speaking on condition of anonymity, she told the BBC she paid 100m kyats (between around $22,000 and $35,000 in recent years) in total. She denied that documents were forged, maintaining that Zeya was her relative."

 

HT: Colin Rowat

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Earlier, also on the Myanmar/India black market

Thursday, December 21, 2023

Cash for kidneys report in the Telegraph

Sunday, February 23, 2025

Helping potential kidney donors lose weight to qualify: Project Donor at RISC

 Many potential kidney donors fail to qualify for reasons involving their own health status. Most commonly they are asked to lose weight before donating, which may not be at all easy to do.

Here's a post on the Effective Altruism Forum about an effort to help donors qualify:

Introducing Project Donor: A cost-effective approach to increasing the number of kidneys available for transplant   By Daniela Shuman, Ruby Rorty, and Steven Levitt

"We can save lives by helping eager living kidney donor candidates who fall short of eligibility requirements (e.g., BMI thresholds) overcome these barriers and qualify for surgery

  • Project Donor is an initiative incubated at the Center for RISC, a think tank at UChicago founded by Steven Levitt. Project Donor is scaling eligibility support for living donor candidates by offering free weight loss, smoking cessation, and emotional support resources to help candidates safely achieve transplant. 
  • In a 2-year pilot program with 353 previously rejected candidate donors, 14% ultimately donated "

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Here's the front page of the Project Donor website:

"Transplant centers and nonprofits refer organ donor candidates to our program if they have been screened out for BMI or smoking.

Interested donor candidates consult with a case manager, who enables free access to top-of-the-line resources like nutritionists, Noom, WW, smoking cessation products, and more! "

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And here's the webpage of Chicago's RISC: Radical Innovation for Social Change

"The Center for RISC is the brainchild of Steven Levitt, professor of economics at the University of Chicago and co-author of Freakonomics."

Sunday, February 16, 2025

Kidneys, compensation, and altruistic activists

 Here's a well written story about kidney donation, and  some of the very interesting people involved in the debate over compensating donors.  It's written by the talented science writer Carrie Arnold, in  Noema magazine (which she described to me as "a pub that has a philosophical bent published by the Berggruen Foundation," when I was among the many people she interviewed for the story). 

 It starts by introducing us to non-directed donors like Elaine Perlman and her son Abie Rohrig (he donated first and she followed). Elaine is now a leader in promoting organ donation and compensation of donors, not least through the End Kidney Deaths Act.   We also meet the indefatigable Frank McCormick, an economist at the forefront of understanding the finances of transplantation (and how much money it saves society and the healthcare system compared to dialysis).

 Here's the story:

How Much Is Your Kidney Worth? To address the deadly organ shortage, some are proposing compensating living kidney donors, creating an ethical dilemma.  By Carrie Arnold , in Noema, February 13, 2025

Ms. Arnold gives me the last word. The very last line of the story concerns the End Kidney Deaths Act:

This is a proposal that just says donors are really generous,” Roth said, “maybe we can be generous to them in return.

Tuesday, February 4, 2025

Clinical trial of pig kidney transplants

 A clinical trial is good news.

The NYT has the story:

F.D.A. Approves Studies of Pig Organ Transplants for Kidney Patients
The research offers hope to tens of thousands of patients with kidney failure who are on a long waiting list for an organ transplant. By Roni Caryn Rabin  Feb. 3, 2025

"The U.S. Food and Drug Administration has given the green light to two biotechnology companies for clinical trials that will transplant organs from genetically modified pigs into people with kidney failure. If successful, these studies could lead to the broader use of cross-species transplantation, a dream of medical scientists for centuries.

One of the companies, United Therapeutics Corporation, will begin its trial with six patients, but that number could eventually rise to 50. The other, eGenesis, said it would begin with three patients and grow the study from there.

...

"Over the past three years, five patients have been known to receive organs from pigs engineered by these companies — two who received hearts and three who received kidneys. But these surgeries were not part of a formal clinical trial.

...

"The United Therapeutics study, which is expected to begin midyear, will start with six patients who have been on dialysis for at least six months but do not have other serious medical problems. There will be a three-month waiting period between each transplant so that doctors can learn from the outcomes.

If the first six transplants are successful, the trial will expand to include up to 50 participants in what is called a phaseless trial — a type of study that combines the traditional Phase 1, Phase 2 and Phase 3 trials and can lead directly to approval."


Tuesday, January 14, 2025

Organ transplant ban by Taliban in Afghanistan (BBC)

 Afshin Nikzad forwards me this report from  the BBC Persian service (in Farsi, but automatically translated by Chrome):

Kidney transplant halted in Afghanistan  by Sajjad Mohammadi

"A number of private hospitals in Kabul and Herat told the BBC that the Taliban government has banned kidney transplants in Afghan hospitals for a month now.

"The Taliban government's Ministry of Encouraging Good and Forbidding Evil announced about a month ago that, according to the seventh paragraph of Article 18 of the ministry's law, the sale and use of human body parts such as kidneys, liver, eyes, and hair is prohibited.

"The ministry said: "The basis and purpose of this decision is to preserve human dignity and respect, and the human body has special sanctity, and its organs should not under any circumstances be used as a means of commercialization or profiteering."

Sunday, January 12, 2025

Exceptional altruism: living organ donors who donate twice

 Some living donors are moved to do it twice: first a kidney, and then later a liver, or the other way around. It appears that this is trending upwards in the last few years.


 

Second Time Around: Increased Rate of Living Donation From Repeat Organ Donors  by Carolyn N Sidoti 1, Kelly Terlizzi 1, Conor Donnelly 1, Ian S Jaffe 2, Jennifer D Motter 1, Benjamin Philosophe 3, Reed T Jenkins 3, Sarah Hussain 3, Pedro Colon 2, Amit D Tevar 4, Bonnie E Lonze 1, Babak J Orandi 1 5, Macey L Levan 1, Dorry L Segev 1 6, Allan B Massie, Clin Transplant,  2025 Jan; 39(1):
 https://onlinelibrary.wiley.com/doi/10.1111/ctr.70049

"Abstract
Introduction: Some living organ donors will decide to donate again at a later date. Evidence has indicated that this practice may have increased in recent years. We evaluated the incidence and outcomes of this practice to inform counseling of potential repeat donors.

Methods: Using SRTR data from 1994 to 2023, we identified 220 repeat living donors and their 415 recipients. We constructed donor comparison groups using weighting by the odds. We described clinical and lab results at 6 months, 1 year, and 2 years post-donation separately for kidney-second donors and liver-second donors. We compared all-cause graft failure for their recipients with those of comparison donors.

Results: The annual count of repeat living donors increased from 5 in 2018 to 25 in 2019 (p < 0.001). Of 220 donors, 159 were liver-second donors (72.3%) and 55 were kidney-second donors (25.0). The percentage of nondirected donations increased from 30.5% at first donation to 53.2% at second donation (p < 0.001). Liver-second donors had one death approximately 2.5 years post-donation. Seventeen were re-admitted and 20 experienced complications requiring an interventional procedure or re-operation. Among kidney-second donors, no deaths, re-admissions, or post-donation complications were reported. Post-donation outcomes in both groups were comparable when evaluated against organ-specific comparison donors. Recipients of repeat living donors experienced graft survival similar to recipients of comparison donors.

Conclusions: Repeat living donation may be a safe practice for carefully selected living donors in the short term; however, long term safety is unknown. Outcomes for recipients are similar to recipients of comparison donors."

...

"The first reported instance of repeat living donation occurred in 1981 when a living kidney donor went on to donate a segment of their pancreas 2.3 years later [1].  

Thursday, December 19, 2024

Another transplant of a pig kidney

A very highly sensitized patient, even one with lots of priority on the deceased donor waiting  list (a prior donor) may not find a compatible human kidney.  Right now pig kidneys are still very experimental. The Washington Post has the story:

Years after donating a kidney, Alabama woman receives one from a pig
She became the third human to receive a genetically engineered pig’s kidney, raising hopes for thousands of Americans on the waiting list for organ transplants. By Mark Johnson

"Twenty-five years after donating a kidney to her mother, an Alabama woman became the third human to receive a genetically engineered pig’s kidney, raising hopes for thousands of Americans on the waiting list for organ transplants, officials at NYU Langone Health announced Tuesday. She is the first live patient to receive a pig’s kidney with 10 gene edits designed to reduce the risk of organ rejection.

...

"In March, doctors at Massachusetts General Hospital performed the first transplant of a gene-edited pig’s kidney, implanting the organ in Richard Slayman, a 62-year-old worker for the Massachusetts Department of Transportation. He lived for 52 days.

"Lisa Pisano, a 54-year-old grandmother, was the next to receive a gene-edited pig’s kidney, the first time such a kidney had been transplanted in a person also receiving a heart pump; the two procedures were performed on different days in April. She survived 86 days, though the gradually failing kidney had to be removed after 47 days.

...

"The gene-edited pig used in Looney’s transplant was developed by Revivicor Inc., a subsidiary of United Therapeutics Corporation.

"The 10 changes to the pig’s genetic code included the removal of three immunogenic antigens, molecules that can trigger an immune response. A growth hormone receptor, which can regulate growth and metabolism, was also removed.

"In addition, scientists gave the pig six human transgenes, pieces of DNA that have been experimentally constructed, and were intended to make the pig organ more compatible to the human body.

"Doctors received permission to perform the procedure under the Food and Drug Administration’s compassionate use program, which allows the use of investigational medical products outside of clinical trials when a patient has a life-threatening condition."

Wednesday, December 18, 2024

New rules for evaluating transplant centers

 Historically, transplant centers ('hospitals') have been primarily evaluated on the one year graft survival on the transplants that they do.*  Now Medicare announces it will test a new model, that will emphasize the number of transplants conducted ("achievement"), in addition to somewhat less emphasis on the ratio of deceased donor kidneys accepted or rejected ("efficiency") and graft survival ("quality").

Medicare Program; Alternative Payment Model Updates and the Increasing Organ Transplant Access (IOTA) Model.  A Rule by the Centers for Medicare & Medicaid Services on 12/04/2024 

"a. Proposed IOTA Model Overview

"End-Stage Renal Disease (ESRD) is a medical condition in which a person's kidneys cease functioning on a permanent basis, leading to the need for a regular course of long-term dialysis or a kidney transplant to maintain life.[2]

"The best treatment for most patients with kidney failure is kidney transplantation. Nearly 808,000 people in the United States are living with ESRD, with about 69 percent on dialysis and 31 percent with a kidney transplant.[3]

"Relative to dialysis, a kidney transplant can improve survival, reduce avoidable health care utilization and hospital acquired conditions, improve quality of life, and lower Medicare expenditures.[4 5]

"However, despite these benefits of kidney transplantation, evidence shows low rates of ESRD patients placed on kidney transplant hospitals' waitlists, a decline in living donors over the past 20 years, and underutilization of available donor kidneys, coupled with increasing rates of donor kidney discards, and wide variation in kidney offer acceptance rates and donor kidney discards by region and across kidney transplant hospitals.[6 7] 

...

"The IOTA Model will be a mandatory model that will begin on July 1, 2025, and end on June 30, 2031, resulting in a 6-year model performance period comprised of 6 individual performance years (“PYs”). The IOTA Model will test whether performance-based incentives paid to, or owed by, participating kidney transplant hospitals can increase access to kidney transplants for patients with ESRD, while preserving or enhancing quality of care and reducing Medicare expenditures. CMS will select kidney transplant hospitals to participate in the IOTA Model through the methodology proposed in section III.C.3.d of this final rule. As this will be a mandatory model, the selected kidney transplant hospitals will be required to participate. CMS will measure and assess the participating kidney transplant hospitals' performance during each PY across three performance domains: achievement, efficiency, and quality.

"The achievement domain will assess each participating kidney transplant hospital on the overall number of kidney transplants performed during a PY, relative to a participant-specific target. The efficiency domain will assess the kidney organ offer acceptance rate ratios of each participating kidney transplant hospital relative to a national ranking or the participating kidney transplant hospital's past organ offer acceptance rate ratio. The quality domain will assess the quality of care provided by the participating kidney transplant hospitals via a composite graft survival ratio. Each participating kidney transplant hospital's performance score across these three domains will determine its final performance score and corresponding amount for the upside risk payment that CMS would pay to the participating kidney transplant hospital, or the downside risk payment that would be owed by the participating kidney transplant hospital to CMS. The upside risk payment will be a lump sum payment paid by CMS after the end of a PY to a participating kidney transplant hospital with a final performance score of 60 or greater. Conversely, beginning in PY 2, the downside risk payment will be a lump sum payment paid to CMS by any participating kidney transplant hospital with a final performance score of 40 or lower. There is no downside risk payment for PY 1 of the model.

...

"The three performance domains will include: (1) an achievement domain worth up to 60 points, (2) an efficiency domain worth up to 20 points, and (3) a quality domain worth up to 20 points.

"The achievement domain will assess the number of kidney transplants performed by each IOTA participant for attributed patients, with performance on this domain worth up to 60 points. The final performance score will be heavily weighted on the achievement domain to align with the IOTA Model's goal to increase access to kidney transplants to improve the quality of care and reduce Medicare expenditures. The IOTA Model theorizes that improvement activities, including those aimed at reducing unnecessary deceased donor discards and increasing living donors, may help increase access to kidney transplants."

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CMS gives a high level overview here: Increasing Organ Transplant Access (IOTA) Model

and later today there's a webinar you can register for:

"The CMS Innovation Center will be hosting a welcome webinar to present an overview of the model on December 18, 2024, from 2 to 3 p.m. ET. Register to attend: https://cms.zoomgov.com/webinar/register/WN_hvGDyZTxQ5eNhX1OBolevA
 

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*see Wednesday, October 2, 2024 Regulation of Organ Transplantation and Procurement (Chan and Roth in the JPE)

That paper suggests desirable regulations  would coordinate transplant and OPO incentives, and link them both to the health outcomes of all patients attributable to a given transplant center (and not just those patients who were transplanted). 

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quick update (from the Q&A following the webinar): 

this is viewed as an experiment on roughly half the transplant centers, but there isn't currently a commitment about what to do after the projected 6 years of the experiment.

. all transplant patients are considered, but payments are only for Medicare fee for service patients

achievement: . each center's target for annual transplants will be it's average number over the three years ending a year before the beginning of the experiment...(at least that was the answer for the first year).

    . both deceased and living donor outcomes will be included in the achievement metric.

quality: .the first year will consider one-year graft survival, and year n will consider graft survival for the first n years.

OPOs: there are no requirements for OPOs within the IOTA model 

risk adjustment: not for year 1, they are hoping to have risk adjustment measures in subsequent years.

Saturday, December 7, 2024

The market for kidneys is strong

 "For 2025, Bickell expects the market for kidneys to be very strong."

Alas, it's a story about kidney beans, from RealAgriculture.com:

Edible Bean School: Genetics and markets drive kidney bean opportunity 

 

Earlier related post: (different market, same joke)

Saturday, August 22, 2020 Organs for sale

 



 

Friday, November 22, 2024

America Has an Organ Shortage. Could Paying Donors Close the Gap? Podcast from BYU radio.

 Here's a podcast on the shortage of organs for transplant, and on the controversies about compensating organ donors, and plasma donors.

America Has an Organ Shortage. Could Paying Donors Close the Gap?   Top of Mind with Julie Rose | BYU radio
 

"There are more than 100,000 people on the waitlist for an organ transplant. Every day 17 of them die. Most organs for transplant come from deceased donors. But the organs in highest demand for transplantation are kidneys and livers – both of which can be donated while a person is still alive. So, we could save thousands of lives each year if more people were willing make a living organ donation. Some advocates say giving donors money would increase organ donations enough to eliminate the entire waitlist. But federal law makes it illegal to buy or sell organs. Ethicists have real concerns about coercion and exploitation, too. In this podcast episode, we're exploring America's organ shortage and asking whether paying donors could close the gap.  
Guests:
David Galbenski, liver transplant recipient and co-founder of the Living Liver Foundation (https://livingliver.org/)

Elaine Perlman, kidney donor, Executive Director of Waitlist Zero and leading advocate for the End Kidney Deaths Act (http://waitlistzero.org/)

Kathleen McLaughlin, journalist and author of Blood Money; The Story of Life, Death, and Profit Inside America's Blood Industry

Al Roth, Nobel-prize winning economist, Stanford University, expert in market design and game theory (https://marketdesigner.blogspot.com/)"


I'm interviewed at the end of the podcast, starting at minute 39:

x

Saturday, November 16, 2024

Income inequality, risk, and repugnance by Hauge, Kverndokk, and Lange

Two recent papers by  Karen HaugeSnorre Kverndokk, and Andreas Lange report on the roles played by inequality and risk in causing repugnance to markets.

First, an experiment, motivated by a hypothetical market in kidneys (expressed in abstract terms), that finds that income inequality boosts repugnance to trade.

Hauge, Karen E., Snorre Kverndokk, and Andreas Lange. "Opposition to markets: Experimental evidence." Journal of Economic Behavior & Organization 227 (2024): 106743.

Abstract: We experimentally investigate reasons for opposing market institutions. The experiment shows that opposition to implementing market institutions varies by background characteristics and shows that distributional concerns are a reason for opposing trade institutions. We find no evidence that the opposition to trade is due to risk preferences or paternalistic motives. A main driver of the opposition to trade is the information about background conditions: veils of uncertainty increase the support for the trade institution.

"This paper reports experimental evidence to better understand potential opposition to market institutions, i.e. for allowing people to trade. For this, we abstract from repugnancy concerns that relate to the specific characteristics of the good or service in question, and rather reduces the setting to the payoff dimension and thus the involved risks and distributional concerns. While we use a neutral framing, organ trade, in particular, trade in kidneys, inspires the set-up of the experiment. Trading kidneys for payment is illegal worldwide, apart from in Iran.1 While it is obvious that persons with kidney issues would substantially benefit from a transplant, healthy donors expose themselves to risk (e.g., Lentine and Patel 2012). Currently, there is not a large income gap between donors and recipients in the US (Gill et al., 2012). Nevertheless, studies suggest that - at a given price - the poor would have larger incentives to donate and therefore, are more exposed to potential risks (Moniruzzaman, 2012; Parada-Contzen and Vásquez-Lavín, 2019) and thus potentially more vulnerable in terms of Satz (2010).2 To illustrate this in the experiment, we vary both the initial income of players (rich/poor) as well as their condition (healthy/sick) which combined affect their potential prospects with and without trade. 

...

"In our experiment, a share of 20 % of respondents across all treatments oppose the trade institution although it is constructed such that personal expected payoff is unaffected or improved. We find that the major reasons individuals vote against trade are the unfair distributions of gains from trade. Importantly, the opposition towards trade is partly self-serving: opposition is lower among those that benefit the most from implementing a market institution. Specifically, we find a significantly smaller opposition to trade institutions when participants are behind the veil of ignorance and do not know their income level, their (abstractly defined) health condition, and thus, how trade affects their payoff. Similarly, we find that distributing gains from trade more evenly, thus benefiting the poor to a larger extent, reduces opposition to trade among the poor."

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And here's a related survey study:

Hauge, Karen Evelyn, Snorre Kverndokk, and Andreas Lange. "On the opposition to market institutions on moral grounds." Humanities and Social Sciences Communications 11, no. 1 (2024): 1-8.

Abstract

"From a liberal viewpoint, voluntary trade appears to be something that should meet universal approval. If no one is obliged to trade, establishing a market institution could only make all better off. Nonetheless, specific market institutions meet substantial skepticism and criticism. This paper extends the extant literature by surveying the moral opposition towards trade in multiple dimensions and linking this to policy support measures. We provide survey results on moral opposition to trade in organs, sex services, surrogate mothers, trade in carbon permits, goods produced in poor countries, and food from countries where people suffer from hunger. These cover the potential reasons for opposing trade institutions: moral concerns, paternalism regarding risk-taking, and distributional concerns. Beyond this, we measure support for policies on unemployment benefits, risk prevention, equality goals within society, and redistribution. The survey of Amazon Mechanical Turk workers from the U.S. reveals significant moral opposition to trade in diverse dimensions. About a third of the participants strongly oppose trade in body items, sex services, and food imports from countries where a large proportion of the population suffers from hunger and malnutrition. Fewer participants strongly oppose trading CO2 permits, importing from developing countries, or allowing surrogate mothership. Besides other correlates (e.g., gender, education, being conservative), individuals’ attitudes towards imposing risks on others are identified as an important correlate of the opposition to trade for all the contexts of trade: those who are averse to exposing others to risk for their own advantage are more likely to oppose trading institutions. This measure of social preferences also relates to support for policies on risk prevention, equality goals within society, and redistribution. We discuss potential mechanisms behind this explanatory power of the newly identified measure."

Tuesday, November 12, 2024

Arguments against paying for plasma and other Substances of Human Origin (SoHO)

 Substances of Human Origin (SoHO) have a growing, often lifesaving role in modern medicine, from breast milk for premature babies, to kidneys for transplant, to blood and blood plasma, which the World Health Organization categorizes as an essential medicine for a wide variety of ailments and injuries.  However concern for protecting the donors of SoHO from exploitation has led to a considerable debate about whether donation must always be uncompensated, and motivated purely by altruism.
 

Two important cases are donation of kidneys and of blood plasma. Payment to donors of kidneys for transplant is banned almost everywhere, but a few countries (among which the U.S. is prominent) allow payment to plasma donors. Kidneys are in short supply, so patients with kidney failure very often die prematurely without receiving a transplant, but among high and middle income countries almost no one is today dying from a shortage of plasma and plasma products.  That isn’t because countries that don’t pay plasma donors generate sufficient supply for their domestic needs, it is because they can import plasma pharmaceuticals from countries that do pay donors, chiefly the U.S. which exports tens of billions of dollars of plasma products annually.
 

Here's an article arguing that payment for plasma and other SoHOs is always and everywhere wrong and should be stopped. (The  authors seem to agree with the WHO that countries should raise enough plasma domestically from unpaid donors, although no country has yet managed to do this.)  Furthermore, they suggest that companies that collect and process plasma must be nonprofits.

Prevention of Trafficking in Organs, Tissues, and Cells by Martin, Dominique E. PhD1; Capron, Alexander M. LLB2; Fadhil, Riadh A. S. MD3; Forsythe, John L. R. MD4; Padilla, Benita MD5; Pérez-Blanco, Alicia PhD6; Van Assche, Kristof PhD7; Bengochea, Milka MD8; Cervantes, Lilia MD9; Forsberg, Anna PhD10; Gracious, Noble MD11,12; Herson, Marisa R. PhD1; Kazancioğlu, Rümeyza MD13; Müller, Thomas PhD14; Noël, Luc MD15; Trias, Esteve MD16; López-Fraga, Marta PhD17 Transplantation, October 22, 2024. | DOI: 10.1097/TP.0000000000005212
 

It is essential that all national laws “concerning the donation and human application” of human organs, tissues, and cells, as well as all derived therapies, conform to the principle of financial neutrality, prohibiting financial gain in the human body or its parts.9,70 Healthcare professionals, service providers, and organ, cell, and tissue procurement organizations, as well as other industry stakeholders involved in processing, manufacture, storage, and distribution of SoHOs and SoHO-based therapies, are all entitled to “reasonable remuneration” for their work and coverage of the costs associated with various sector activities.66,71 However, what may be considered a reasonable and proportionate remuneration in this context is ill defined. There have been reports of service providers and professionals generating disproportionate profits from such activities, creating potential financial conflicts of interest in service provision and potentially violating ethical norms and legal standards prohibiting trade in SoHOs.30
 

“Development of innovative therapies using human cells and tissues has increased, with the potential therapeutic value of these resources spurring commercial interests that, in some cases, has led to practices in which donated SoHOs are treated as commodities.30,72–75 Furthermore, some SoHOs may undergo substantial processing, resulting in these therapies being regulated outside the regulatory framework governing the transplantation of organs, tissues, and cells as such, and rather being considered as medicines, where commercial profits are expected and guide the production and distribution activities.74,75
 

“Mechanisms should be developed to ensure that strategies used in donor recruitment, which may involve actual or perceived financial incentives, are routinely disclosed and open to scrutiny.70 Transparency of practice is also required to enable scrutiny of the fees charged to cover costs of procuring, processing, storing, manufacturing, and distributing cells, tissues, and SoHO-based therapies and to assess the potential influence of financial interests on decision-making about the use of SoHOs in particular SoHO-based therapies, or distribution of SoHO-based therapies.74 These measures would furthermore help to facilitate equitable access to treatments for all patients.21

Box 1, first recommendation
“Recommendations for action to prevent trafficking in SoHOs
•    1. All countries should establish laws that prohibit payment for donation of SoHOs, trafficking in SoHOs, and trafficking in human beings to obtain SoHOs.
o    a. Legislation should prohibit activities that make the human body or its parts a source of financial gain exceeding the recovery of the costs of obtaining, processing, storing, and distributing those parts or the products made from them and of ensuring the sustainability, safety, and quality of donation and transplantation systems.”

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They also suggest that there is widespread human trafficking in SoHO, although they acknowledge that there isn’t a lot of data to support this:

“since 2010, there have been few empirical studies of organ trafficking, with more recent studies often consisting of qualitative interviews or surveys with individuals who participated in organ trafficking or were victims of human trafficking for organ removal several years earlier.7,32,52 Legal case analyses have focused primarily on seminal cases that detail activities that occurred in the early 2000s.33,38 Much of what is known about current trafficking activities is gleaned from sporadic media reports, which make clear the global prevalence of organ trafficking.”

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Earlier:

Wednesday, August 28, 2024  WHO Says Countries Should Be Self-Sufficient In (Unremunerated) Organs And Blood, by Krawiec and Roth

Monday, April 22, 2024 Plasma donation in the EU: compensated and uncompensated

Saturday, November 4, 2023  The EU proposes strengthening bans on compensating donors of Substances of Human Origin (SoHOs)--op-ed in VoxEU by Ockenfels and Roth