Are transplants too scarce, or not scarce enough? A surprising debate about India

 India, now the most populous country in the world, does the third highest number of kidney transplants in the world (although their rate of transplantation per million population is quite low).  So transplants are nevertheless very scarce in India compared to the need, which is the situation worldwide.

Earlier this year, however, a paper by three veteran (non-Indian) transplant professionals who have headed large organizations expressed repugnance for the volume of transplants in India, and the fact that it depends mostly on living donor transplantation (LDT), suggesting it can be viewed as "both alarming and reprehensible."  Their paper's title makes it clear how they view it. 

Domínguez-Gil, Beatriz, Francis L. Delmonico, and Jeremy R. Chapman. "Organ transplantation in India: NOT for the common good." Transplantation 109, no. 2, February, 2025: 240-242. 

"The field of organ transplantation has evolved very differently across the world under the influence of different national healthcare financing systems. Healthcare is, in most countries, financed by taxation and thus through governmental budgets, in combination with private funds, mostly through contributory health insurance systems (eg, Australia, Canada, Europe, New Zealand, South America, and the United States). But across much of Asia, tertiary healthcare services, such as transplantation, are almost entirely dependent on the private finances of individuals. The impressive growth in Indian organ transplantation has been accomplished in for-profit hospitals, which have expanded Indian transplantation into 807 facilities, mostly associated with the major corporate hospital chains.6 Organ transplantation, in a part of the world where one-fifth of all people live, is thus largely not for the common good, but a treatment available for those with ample monetary resources." 

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 This was followed by a firm rebuttal by distinguished Indian transplant professionals.  Their title makes their view equally clear:

Rela, Mohamed, Ashwin Rammohan, Vivek Kute, Manish R. Balwani, and Arpita Ray Chaudhury. "Organ Transplantation in India: INDEED, for the Common Good!." Transplantation 109, no. 6 (2025): e340-e342. 

 "We were deeply concerned by the article “Organ Transplantation in India: NOT for the Common Good” by Domínguez-Gil et al,  which we felt provided an unfairly critical view of the current state of organ transplantation in India. We aim to provide a point-by-point rebuttal based on actual figures and ground-reality rather than tabloid-press articles as cited by the authors.
 

"It is true that in the past 5 y, there has been an extraordinary growth in the number of transplantations in India (more than those achieved over several decades by European countries). While it is natural to be wary of this astronomical increase in transplant numbers, the authors’ assumption that this growth is likely nefarious reflects an outdated western mindset, rather than a true understanding of over 2 decades of massively coordinated effort by the Government of India, transplant professionals and all other stakeholders in the country. 

...

" The development of LDT has been presented with a negative connotation. This shows a scant understanding of the geo-socio-political idiosyncrasies prevalent in the Asian region, and unlike the west, its conventional dependence on LDT.

 ...

"The authors have further confused LDT and deceased donor transplantation with regards to foreigners having access to organs in India. The authors’ accusation of deceased donor organs being preferentially allocated to foreigner is presumptuous at best. The current organ allocation system under the aegis of the Government of India and state-wise organ transplant governing bodies is a very transparent process—and is reserved for Indian nationals.

...

" Transplant tourism being equated with organ commerce is erroneous, the authors’ fail to understand that many poor countries find India a more financially viable destination to get a transplant than countries in the west. Even affordable Governments in the middle east are moving to the east for transplantation, where the ministries have a direct tie-up with transplant units. 

"While it should be conceded that transplantation in India may not be available to all, true social upliftment necessitates broader initiatives beyond just immediate transplant availability: that of addressing poverty. Nonetheless, access to transplants for the underprivileged has greatly improved over the past decade. There are several public sector hospitals in the country that routinely provide transplantation services. In 2023, in the state of Tamil Nadu, 35.1% of all deceased donor renal transplants were performed for free in public sector hospitals (Table 1). 5 While traditionally, the private pay-from-pocket healthcare has been only for those with the resources, the central and several state governments (Tamil Nadu, Andhra Pradesh, Gujarat, etc) sponsor an all-inclusive healthcare state insurance for the poor, which includes transplantation at any approved private hospital in the state; which includes LDT.

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I'm on my way to a conference in Cairo that is motivated in part by concern that healthcare in low and middle income countries has been impeded by some of the international healthcare organizations' lack of understanding or empathy for their situations. 

Xenotransplants go to (clinical) trial

 Yesterday's post was about a man who received a pig kidney as an exceptional "compassionate use" case. But now some formal clinical trials of xenotransplantation are beginning. 

 Medpage Today has the story:

First Clinical Trial of Pig Kidney Transplants Gets Underway
— Study's initial transplant was performed successfully
by Associated Press, November 4, 2025  

"The first clinical trial is getting underway to see if transplanting pig kidneys into people might really save lives.

"United Therapeutics, a producer of gene-edited pig kidneys, announced Monday that the study's initial transplant was performed successfully at NYU Langone Health in New York City.

"It's the latest step in the quest for animal-to-human transplants. A second U.S. company, eGenesis, is preparing to begin its own pig kidney clinical trial in the coming months. These are the first known clinical trials of what is called xenotransplantation in the world. 

...

"Robert Montgomery, MD, PhD, of NYU, who led the transplant team, told the Associated Press his hospital has a list of other patients interested in joining the small trial, which will initially include six people. If all goes well, it could be expanded to up to 50 as additional transplant centers join.

"The FDA is allowing the rigorous studies after a series of so-called "compassionate use" experiments, with mixed results. The first two gene-edited pig kidney transplants were short-lived.

"Then doctors began working with patients who badly needed a kidney but weren't as sick as prior recipients. At NYU, an Alabama woman's pig kidney lasted 130 days before she had to return to dialysis. The latest record, 271 days, was set by a New Hampshire man transplanted at Massachusetts General Hospital (MGH) in Boston; he also is back on dialysis after the pig organ began declining and was removed last month. Others known to be living with a pig kidney are another MGH patient and a woman in China. "

Xenotransplant of a pig kidney lasted nine months before failing (a new record)

 No xenotransplant has lasted a year yet, but that's a target that now seems to be within reach for kidneys. (Kidneys are a more forgiving test of xenotransplants than, say, hearts, since after graft failure the patient can remain alive on dialysis once again.)

The NYT has the story:

Pig Kidney Removed From Transplant Patient After Nine Months
Tim Andrews, 67, lived with a genetically modified organ longer than any other recipient. By Emily Anthes

"Surgeons removed a genetically modified pig kidney from a 67-year-old man last week, nearly nine months after he received the pioneering procedure at Massachusetts General Hospital in Boston, officials said on Monday. The kidney was removed “after a period of decreasing kidney function,” according to a statement from the hospital.

"The patient, Tim Andrews, lived with the pig kidney for a record-setting 271 days. He was the fourth person in the United States to receive a genetically modified pig kidney. The first two patients died shortly after their transplants; the third had her kidney removed after 130 days, when her body rejected the organ.

“Tim set a new bar in xenotransplantation,” the Mass General Brigham statement said, referring to the process of transplanting organs from one species into another.

"Mr. Andrews “will now resume dialysis and remain on the list for a human donor kidney,” the hospital added."
 

Race to the bottom: NLDAC and NY State both aim to be payers of last resort for reimbursing kidney donors

A tale of bureaucracy, in two acts 

1.  NLDAC, the federally funded National Living Donor Assistance Center, was for a long time the only organization that would reimburse  some expenses of living organ donors who qualified by not having high incomes, or any other sources for reimbursements.  That is NLDAC is a funder of last resort:

" Individuals considering becoming a living organ donor can apply for help with their travel expenses, lost wages, and dependent care expenses from NLDAC if they cannot be reimbursed for these costs by their recipient, a state program, or an insurance company.

2. In (very) late 2022,  New York State's Living Donor Support Act (LDSA, S. 1594) became law, and it is about to go into effect this year. The Act provides "state reimbursement to living organ donors, who are state residents, for medical and associated expenses incurred as a result of the organ donation, when the organ donation is made to another resident of the state" 

It further defines NY State as a payer of last resort:, and explicitly rules out payments to donors eligible for payment by NLDAC.

" THE  PROGRAM  SHALL  NOT  PAY  REIMBURSEMENT FOR EXPENSES PAID OR  REQUIRED TO BE PAID FOR BY ANY THIRD-PARTY  PAYER,  INCLUDING  WAGES  OR  OTHER  EXPENSES THAT WERE COVERED UNDER PAID MEDICAL LEAVE BY THE LIVING  DONOR'S EMPLOYER OR THAT ARE COVERED BY OTHER SOURCES  OF  REIMBURSEMENT  SUCH  AS  THE  FEDERAL  NATIONAL  LIVING  DONOR  ASSISTANCE PROGRAM. THE  PROGRAM SHALL BE THE PAYER OF LAST RESORT WITH RESPECT  TO  ANY  BENEFIT  UNDER THE PROGRAM. " 

 

I'm on NLDAC's mailing list, and  a few days ago received an email containing their policy statement on the NY State law. They say they will no longer make payments to NY residents who are covered by the NY State law.

 

 

 

Incidentally, here's my blog post from when the NY State law was passed:

Sunday, January 1, 2023 New York State's Living Donor Support Act (LDSA, S. 1594) was signed by Governor Hochul on Dec. 29

 "like the authorization for NLDAC,  the NY State law (https://www.nysenate.gov/legislation/bills/2021/S1594) "requires that the Program shall be payer of last resort..." I hope that this doesn't turn into a competition to be the payer of last resort in a way that might cause some NY donors to fall between the cracks, and not be reimbursed either by NLDAC or the State of New York."

 

I suppose the larger lesson is that designers of competing markets can create paradoxical situations. 

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Related:

Sunday, July 16, 2023  National Living Donor Assistance Center (NLDAC): I rotate off the advisory board

 

Xenotransplantation in Humans: pig organs edge closer to being clinically kosher

  It has long been the conventional wisdom in transplantation that xenotransplants--transplanting a kidney from a genetically modified pig into a human--will be tomorrow's cure for kidney failure, and always will be.

But lately there are some causes for optimism that the timeline may be quicker than that.

Here's a recent review of the evidence:

Xenotransplantation in Humans: A Reality Check, by A. Joseph Tector, MD, PhD
Transplantation 109(2):p 231-234, February 2025. | DOI: 10.1097/TP.0000000000005223 

"Thirty years after the initial strategies to develop genetically engineered pigs for use as organ donors in xenotransplantation were described, evaluation of these pig organs in humans has begun.1 The initial experience includes decedent experiments in kidneys and hearts, as well as 5 clinical cases (2 hearts, 2 kidneys, and 1 auxiliary liver). The cardiac xenograft survival was 47 and 40 d, whereas patient survival was 60 and 40 d.2-4 In the initial kidney xenografts, patient survival was 52 d for the first kidney, and the second kidney was removed at 47 d with the patient still alive in the intensive care unit. The initial results in the decedent work as well as the clinical cases indicate that the initial barrier of hyperacute rejection (HAR) has been averted with genetic engineering, but that much work remains before we can begin to offer xenotransplantation as a routine therapy for the treatment of end-stage organ failure. Evaluation of the renal xenografts in decedents and the 2 cardiac xenografts make it clear that although HAR is no longer an issue the problem of antibody-mediated rejection (AMR) secondary to xenoantigens on the pig cell remains.5,6 Moving forward, 4 key areas that must be addressed to realize the goals of bringing xenotransplantation to clinical practice are (1) patient selection, (2) donor pig genetics, (3) immunosuppression issues, and (4) animal husbandry challenges."

 

 Here's the paper's final sentence:

"The human experience suggests that clinical xenotransplantation will work sooner rather than later, but there is still some heavy lifting in front of us that will require continued careful detailed laboratory investigation guided by the feedback from preclinical evaluation."

WHO Resolution on Kidney Disease and Transplantation

The  78th World Health Assembly in May, 2025 recognized kidney failure as a global problem, with transplantation as the preferred treatment.

Here's a news story from the International Society of Nephrology (ISN):

Historic win for kidney health as WHO adopts global resolution

Here's the resolution:

WHO Resolution: Reducing the burden of noncommunicable diseases through promotion of kidney health and strengthening prevention and control of kidney disease

"The Seventy-eighth World Health Assembly

...

"(PP5) Recognizing that approximately 674 million people live with chronic kidney disease, comprising 9% of the global population2 and concerned that kidney disease is one of the fastest-growing causes of death globally and is projected to become the fifth leading cause of death by 2050, with a projected 33% increase in age-standardized death rate and a 28% increase in age-standardized disability-adjusted life years (DALYs) if no action is taken;

"(PP6) Recalling resolution WHA77.4 on increasing the availability, ethical access, and oversight of the transplantation of human cells, tissues, and organs, which urges countries to adopt preventive strategies and incorporate transplantation into the continuum of care of non-communicable and other diseases that may lead to the need for transplantation in accordance with their national contexts, and that requests the Director-General to support Member States in implementing the elements of the Resolution, particularly through the design of a Global Strategy on Donation and Transplantation." 

...

" URGES Member States, in accordance with their national context and priorities, to: 

...

"(6) take measures to promote progressive access to kidney replacement therapy, of which kidney transplantation is preferred, enabling timely referral for transplantation, as well as by implementing interventions to maximize the availability of organs for clinical use aligned with the WHO Guiding Principles on human cell, tissue and organ transplantation"

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 As I've noted elsewhere, the WHO has some counterproductive policies regarding transplantation (and blood and plasma donation, etc), but this particular resolution seems like a positive one.

Kidney Transplants in Pakistan. Many patients unaware that paying donors is illegal.

Here's a recent paper on  "Barriers to Kidney Transplants in Pakistan.  A striking fact is that only 4.9% of patients with kidney failure were aware that paying a donor is illegal in Pakistan.

 Afzal, Aurangzeb, Muhammad Ahmad Rauf, Zohra Khanum, Hafiza Sumaira Rahman, Zahid Rafique, Areeba Gulzar, Waqas Rasheed, Jehangir Afzal Mobushar, Beenish Abbas Bajwa, and Muhammad Ahmad Rauf IV. "Barriers to Renal Transplant in Pakistan." Cureus 17, no. 5 (2025).

 

  ...

"The study revealed limited knowledge regarding legal restrictions on kidney donation, with only 9.8% aware that non-related persons cannot donate kidneys according to the law, and a mere 4.9% knowing that financial compensation for donation is illegal. This lack of awareness may perpetuate illegal organ trade and exploitation [4]. Educational initiatives targeting both patients and the general public are essential to promote ethical transplantation practices and protect vulnerable populations."

Deceased organ allocation: deciding early when to move fast

The deceased donor waiting list for kidneys to transplant is congested: offers, which take time to evaluate, are often rejected, while cold ischemia time accumulates.

 Here's a paper just published in Transplantation, in which we suggest new ways to detect organs that will be hard to match, and which might therefore be expedited through the allocation process (to get more quickly to patients who will accept them).

Insights From Refusal Patterns for Deceased Donor Kidney Offers, by Guan, Grace MS1; Neelam, Sanjit MS2; Studnia, Joachim MS2; Cheng, Xingxing S. MD, MS3; Melcher, Marc L. MD, PhD4; Rees, Michael A. MD, PhD5,6; Roth, Alvin E. PhD7; Somaini, Paulo PhD8; Ashlagi, Itai PhD1
Author Information
Transplantation ():10.1097/TP.0000000000005434, May 21, 2025 

"Background.
The likelihood that a deceased donor kidney will be used evolves during the allocation process. Transplant centers can either decline an organ offer for a single patient or for multiple patients at the same time. We hypothesize that refusals for a single patient indicate issues with individual patients, whereas simultaneous refusals for multiple patients indicate issues with organ quality.

Methods.
We investigate offer refusal patterns between January 1, 2022, and December 31, 2023, using Organ Procurement and Transplantation Network data. We aggregate refusals at the same timestamp by a center and define a multiple patient refusal as >1 or >5 patients simultaneously refused. We report the refusal codes associated with single and multiple patient refusals and the nonutilization rate after receiving single and multiple patient refusals by cross-clamp.

Results.
Patient-related refusal reasons are more commonly single patient refusals, whereas organ-related refusal reasons are more commonly multiple patient refusals. Multiple patient refusals before cross-clamp are associated with nonutilization, but single patient refusals are positively correlated with utilization. The nonutilization rate was 28% for organs without pre-clamp refusals, 35% with a single center sending a multiple patient refusal, but only 12% with a single center sending a single patient refusal.

Conclusions.
The risk of nonutilization can be assessed early in the offering process based on the number of single and multiple patient refusals received by a specific time (e.g., cross-clamp). Understanding refusal patterns can guide the development of transparent protocols for accelerated placement."

 

Chronic diseases in the U.S.

 The top three chronic diseases--Hypertension, Obesity, and Diabetes--all contribute to the fourth, Kidney Disease.

How Chronic Disease Became the Biggest Scourge in American Health
Americans live shorter and sicker lives than people in other high-income countries   By  Brianna Abbott  | Graphics by  Josh Ulick