Organ transplants between Hong Kong and mainland China: the promise and the politics

 This is a followup post to an earlier post# about the first cross border transplant in China between the mainland and Hong Kong. That's been followed by some political tensions, as reported in this forthcoming article in the American Journal of Transplantation.

A plan to save lives: Hong Kong–mainland China second-tier mutual assistance allocation. The new program between the transplant communities plays out on a backdrop of controversy and historical tension  by Lara C. Pullen, PhD, Published:July 28, 2023DOI:https://doi.org/10.1016/j.ajt.2023.07.015

"Key points:

"The transplant communities of Hong Kong and mainland China have proposed a second-tier mutual assistance allocation program that some find controversial.

• Tensions between Hong Kong and mainland China have a long and deep history.

• In 2014, the Chinese government announced a stop to obtaining organs from executed prisoners.

• Transplantation in mainland China has rapidly evolved, and people monitoring the change report that data from 10 to 15 years ago does not reflect the country’s current system."

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The background:

In December, the South China Morning Post carried this story about a transplant involving an organ recovered on the mainland and transplanted into a baby in Hong Kong, which was apparently the first such  transplant to cross that border:

4-month-old Hong Kong girl suffering from heart failure receives successful transplant with donated organ from mainland China, in city’s first such arrangement by Cannix Yau

One of the subheadlines is "Health Bureau notes importation of organ met relevant regulations, and hospital officials say arrangement involving mainland might be repeated in future"

***

And here's the story in the China Daily:

Securing a new lease of life By Li Bingcun | HK EDITION | Updated: 2023-03-31 15:10

"Hong Kong and the Chinese mainland have successfully carried out the first-ever cross-boundary organ-sharing operation, saving the life of an infant. The feat caps the city’s strenuous efforts to create a standing mechanism in organ sharing with the mainland to save more lives. Li Bingcun reports from Hong Kong."

***

Apparently the discussion of closer cooperation between transplant authorities in Hong Kong and the mainland is politically fraught. 

Here's a story from the Global Times that refers to some pushback from the mainland:

First organ donation between mainland and HK saves 4-month old baby By Wan Hengyi

"the acceptable heart donation for Cleo requires a donor weighing between 4.5 kilograms and 13 kilograms, and the chances of a suitable donor appearing in Hong Kong are slim to none. 

...

"COTRS initiated the allocation of a donated heart of a child with brain death due to brain trauma in the mainland on December 15. As a very low-weight donor, no suitable recipients were found after multiple rounds of automatic matching with 1,153 patients on a national waiting list for heart transplants in the COTRS system. In the end, the medical assistance human organ-sharing plan between the Chinese mainland and Hong Kong was launched.

"Some netizens from the Chinese mainland asked why a baby from Hong Kong who has not lined up in the COTRS system can get a donated heart when there is a huge shortage of donated organs in the mainland.

"In response, the organ coordinator told the Global Times that the requirements for organ donation are extremely high, noting that all the prerequisites including the conditions of the donor and recipient, the time for the organ to be transported on the road and the preparation for surgery must reach the standards before the donation can be completed.

"The COTRS system has already gone through several rounds of matching, which is done automatically by computer without human intervention, said the organ coordinator. "

...

"As of the end of October 2022, a total of 42,500 donors had donated more than 126,300 large organs in China, according to Guo Yanhong, director of the medical emergency department of the NHC."

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Here's a story from the Guardian, about political concerns on the Hong Kong side:

Hongkongers opt out of organ registry ‘amid fear of Chinese donations’      by Amy Hawkins

"Thousands of Hongkongers have opted out of the city’s organ donor registry, seemingly as a form of subtle protest against proposals to establish deeper medical ties with mainland China.

...

"The trigger appears to have been a life-saving operation carried out in December on a four-month-old baby girl in Hong Kong, who was in need of a heart transplant. When a local match could not be found, a heart was transferred from a child who had suffered brainstem death in mainland China.

...

"Since the baby’s heart transplant, authorities have discussed the idea of establishing a mutual assistance registry with mainland China to facilitate future donations. That would be yet another erosion of the boundary between China and Hong Kong, which was supposed to remain largely autonomous from Beijing until 2047.

"Earlier this month, local news outlet Ming Pao reported that there had been discussion on social media among Hongkongers who did not want their organs donated to patients in mainland China."

********

China has a population approaching 1.5 Billion people, and Hong Kong is a city of about 7.5 Million people, so my guess is that HK is too small to have an efficient self-contained transplant system, and could benefit from being integrated into the mainland's system.

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#Here's my earlier (contemporaneous) post:

Tuesday, January 10, 2023

Cross-border transplantation between China and Hong Kong

Incentives for deceased organ donation, in Asia

 Here's a discussion, in an Asian context, of providing incentives to families to consent to deceased donation.

Introducing Incentives and Reducing Disincentives in Enhancing Deceased Organ Donation and Transplantation by Kai Ming ChowMBChB⁎ Curie AhnMD† Ian DittmerMBChB‡ Derrick Kit-SingAuLMCHK§ IanCheungMBBS║ Yuk LunChengMBChB¶ Chak SingLau MBChB Deacons Tai-KongYeungMBBS║ Philip Kam-TaoLi MD Seminars in Nephrology,  Available online 27 December 2022

*Department of Medicine and Therapeutics, Carol and Richard Yu PD Research Centre, Prince of Wales Hospital, The Chinese University of Hong Kong, Shatin, Hong Kong

† Department of Internal Medicine, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, South Korea

‡Department of Renal Medicine, Auckland City Hospital, Faculty of Medical and Health Sciences, University of Auckland, Auckland, New Zealand

§Centre for Bioethics, Faculty of Medicine, The Chinese University of Hong Kong, Shatin, Hong Kong

║Cluster Services Division, Hospital Authority, Kowloon, Hong Kong

¶Department of Medicine, Alice Ho Miu Ling Nethersole Hospital, Tai Po, Hong Kong

#Department of Medicine, Queen Mary Hospital, University of Hong Kong, Pok Fu Lam, Hong Kong, China

Summary: Despite the effectiveness of solid organ transplantation, progress to close the gap between donor organs and demand remains slow. An organ shortage increases the waiting time for transplant and involves significant costs including patient morbidity and mortality. Against the background of a low deceased organ donation rate, this article discusses the option of introducing incentives and removing disincentives to deceased organ donation. Perspectives from ethics, general public opinion, and the health care profession are examined to ensure a comprehensive appraisal and illustrate different facets of opinion on this complex area. Special cultural and psychosocial considerations in Asia, including the family based consent model, are discussed.

This sentence caught my eye:

"After suggestion by Economics Nobel Laureate Alvin Roth for the community to unite to remove disincentives to kidney donation, the transplant community and academia have been having more discussion and analysis. That, in part, hinges on the estimates of the economic welfare gain for the society as a whole."

...

"PERSPECTIVES OF ASIAN SOCIETY

"It is widely recognized that deceased organ donation rates in Asian countries have been significantly lower than that in Western countries.

...

"No one disputes the social and cultural beliefs in the decision to donate organs. 

...

"An example of honoring the principles of reciprocity in incentivizing organ donor registrations is the organ allocation priority policy. Israel became the first country in 2008 to enact legislation incorporating such incentives based on individuals’ willingness to donate into their organ procurement system.26,42,43 The policy provides an incentive or motivation by the reciprocal altruistic dictum that “each partner helping the other while he helps himself,”42 granting priority on organ donor waiting lists to those individuals who registered as organ donors by signing a donor card for at least 3 years. Subsequent observations in Israel, as analyzed 5 years after introduction of the new policy, included an increase in the authorization rate of next of kin of unregistered donors, as well as a two-fold higher likelihood of next-of-kin authorization for donation when the deceased relative was a registered donor.44

"How does the concept of reciprocity apply for Asian societies? Will the results from Israel be replicated in Asia? Although social exchange theory should be a universal normal applicable to all human relationships, cultural influence or patterns might differ. Previous research on reciprocity across different cultural contexts, indeed, has shown that East Asians tend to reciprocate in kind and emphasize more on equity-based theory than Americans.45 Viewed through such a lens of “to give is to take,” it is relevant to quote another similar example in Taiwan, where incentives were provided to deceased organ donors’ families. In brief, after a person has become a deceased organ donor in Taiwan, up to three of his or her blood relatives will be granted priority to receive a deceased donor organ should they be on the waiting list for transplantation.46

"At the heart of the issue is the family based consent that is unique and vital, albeit not exclusive, in Confucian tradition within Chinese societies. It is important to note that organ donation is more often a family based consent process in Chinese culture than those “from a Western cultures”. As such, family priority right provided in the Israel or Chinese model would be more likely to motivate organ donation within a family based ethical culture.47 As in any discussion of culture's influence on organ donation decision, we must be mindful that East Asians tend to favor family centered decision making.

...

"If the concept of reimbursing funeral expenses for deceased organ donors is explored further then these four tenets are suggested as a guide: Tenet 1: the overarching principle is to appreciate and recognize the altruistic behavior of organ donors, and not the next of kin. Tenet 2: the second priority of reimbursing funeral expenses is to motivate the passive-positive public to sign up for organ donation. Tenet 3: the ultimate beneficiary from an incentive system is society, with an improved deceased organ donation rate. Government and charitable organizations, but not organ recipients, should be the source of payment. Tenet 4: as a token of expressing gratitude to the deceased organ donors, funeral expenses reimbursement preferably should be offered to those who have expressed the wish to donate (donor registration); they should have been provided the option to decline the offer."

Voluntary deceased organ donation in China

It's always hard to parse the Chinese organ data, and know what is going on in the military hospitals, but here's an encouraging story

Chinese Organ Donation on the Rise
   2015-12-06 21:11:39    Xinhua      Web Editor: Guan Chao

"Chinese organ donation has been on the rise after the country banned the use of prisoners' organs for transplant starting Jan. 1 this year, a top medical expert said Sunday.

As of Nov. 9, China has recorded 5,384 voluntary organ donors, who donated 14,721 various organs, said Huang Jiefu, head of a national human organ donation and transplant committee and former vice health minister.

China is expected to top the world in terms of organ donation in several years, said Huang at a forum in the central city of Changsha.

"As long as the donation system is transparent, most of citizens will be willing to join the program," he said.

The shortage of qualified transplant doctors is a major bottleneck. There are only 169 hospitals across the country eligible for organ transplant, with some 100 doctors able to do the operation, said Huang.

Huang called for speedy training of medical talent and expanding the number of hospitals eligible for organ transplant to 300 and the number of doctors to 400 to meet the public demand.

China began a voluntary organ donation trial in 2010 and promoted the practice across the country in 2013. Now, it tops Asia in the number of organ donations."

Different views of organ donation in China

When I visited the Ministry of Health in Beijing last Friday, their estimate was that 60% of the organs used for transplant still come from executed prisoners.  They defend this practice (in part by saying that the prisoners consent to this donation), while at the same time indicate that they would like to build a system of voluntary donation to replace it.  Subsequently I had some very interesting conversations about that in Hong Kong, which I'll try to blog about sometime soon.

Two stories from Australia illustrate the debate that is going on in China and around the world regarding how China's organ donation policy should be regarded. No one denies that it still relies heavily on organs from executed prisoners, although not as heavily as in the past.

A focus of this debate, at least in the press, has been Dr.Jeifu Wang, a transplant surgeon who was recently China's deputy minister for health. He was educated in Australia, and has recently become a subject of controversy after the University of Sydney offered him an honorary degree.  The first article takes issue with that, and the second details his position.

Honorary Professor Was an Organ Harvester, Say Critics

"A prestigious Australian university has come under scrutiny recently for giving an honorary professorship to a former top Chinese health official who has been involved in unethical organ harvesting. 

Researchers of organ harvesting in China spoke to the influential Australian news program the “7:30 Report” with information about Huang Jiefu’s involvement in organ harvesting in China; they called on the University of Sydney to rescind the honorary professorship they gave to Huang in 2008 and renewed in October 2011.  "

DOCTOR HITS BACK OVER TIES TO CHINA ORGAN HARVESTING

"Last year there were 5,846 kidney transplants in China and more than half of the organs came from prisoners. Of all liver transplants, 80 per cent came from executed prisoners.

"We call it human value," Dr Huang said. "Everybody has a weak point and a strong point. So in the human values you can say 'he's a bad man, he's not on the good side'.

"So then before he died he found his conscience and found he needed to do something to repay society. So why do you object?"

"While Dr Huang, a transplant doctor who studied at the University of Sydney, says his own practice has not taken any organs from the prisons for two years, he continues to defend the policy.

"I feel that at first I respect the donor. I think that probably he committed some very severe crime," he said.

"It's not my part, it's the judicial part to deserve the death penalty. However I respect his last will. I respect the life he donated for another three people."

Kidney Exchange in Hong Kong

While liver exchanges have been done for some time in Hong Kong, possibly the first kidney exchange  has recently been reported by China Daily:

Exchanging the hope of life By Li Bingcun | HK EDITION |  2023-06-16 

"It was the first time that paired kidney transplants had been carried out in the city. Following a pilot program launched in 2018, if a patient's family member is willing to donate a kidney to the patient but their conditions do not match, the family is allowed to make a cross-donation with another family in the same situation. Previously, organ donations from living donors could be made only by close blood relatives and spouses.

"In addition to kidney transfers, Hong Kong has accomplished several cross-family liver transplants since 2009 with special approvals made by the Human Organ Transplant Board on a case-by-case basis. Facing a severe shortage of organ donations, Hong Kong is drawing on overseas experiences to widen the scope of donations from living donors by trying to overcome restrictions concerning blood type and marriage, seeking greater matching possibilities to achieve more life-saving miracles.

"These attempts involve considerable efforts to update traditional mindsets, address the accompanying ethical and legal issues, and protect the safety and interests of donors and recipients to the fullest extent.

However, because of risks to donors, medical experts suggest that organ donations from living people should never be the first choice, and that the priority should be boosting people's willingness to register as organ donors, allowing organs to be reused after registered people die.

"Globally, such kidney exchange programs have been introduced in South Korea, the United States, the United Kingdom, Australia and Canada, with surgeries performed two decades ago.

"Besides paired donations, the US also allows "nondirected donations", which means a donor can donate his or her kidney to any compatible patient. The largest kidney swaps were completed in 2014, involving 70 participants. Some global exchange programs have also carried out transnational kidney donations.

"With Hong Kong's relatively low organ-donation rate, more than 2,000 local residents are awaiting kidney transplants each year, with an average waiting time of about five years, and the longest 29 years. The number of kidney donations from living family members is less than 20 annually, while the number of cadaveric donations declined from 84 in 2012 to 45 in 2022.

"Although renal-failure patients can receive dialysis to sustain their lives, organ transplantation is still the best option. Moreover, the quality of organs of living donors is considered better than that of cadaveric organs.

"To offer patients another option, Hong Kong had been preparing to introduce the paired kidney donation (PKD) program since 2012, according to Chau Ka-foon, former co-chairperson of the Hospital Authority's Paired Kidney Donation Working Group. After extensive discussions, the city revised the law in 2018 and officially launched the program.

...

"two families that were successfully matched in 2020 canceled their planned surgeries due to personal concerns. Chau explains that the families might have worried that the organ received was of lower quality than the one they donated. It would also be a heavy blow if a family donating a kidney were unable to receive one if an operation were to fail.

...

"Attempts to swap organs among strangers have also encountered complex legal and technical problems.

"In Hong Kong's first-ever cross-family transplant in 2009, the medical team made a lot of efforts explaining to the Human Organ Transplant Board that the operation wasn't a transaction. "We repeatedly emphasized that the two families did not intend to exchange organs. It was simply the medical workers' proposal to raise the success rate of organ transplants," says Lo Chung-mau, chief surgeon of the operation and also director of the liver transplantation center at Queen Mary Hospital at that time.

...

"The 2019 social unrest and the following COVID-19 pandemic presented even greater challenges for Hong Kong's PKD program. In 2021, there were 26 eligible families in the city's organ matching pool.

"The Hospital Authority expects the number of participating families to climb to 50 to 100 in a few years. It will consider expanding the program to liver donations and collaborating with overseas matching pools. Chau hopes that kidney swaps will not be limited to just two families, and that multiple swaps among several families will be allowed to increase the chances of matching.

...

"Wang Haibo, a member of China's National Organ Donation and Transplantation Committee, says the pair-donation program is worth looking into and being discussed. The mainland is also conducting clinical research on paired-kidney donations. Alvin Roth, who won the 2012 Nobel Memorial Prize in Economic Sciences and developed a global kidney-exchange program, visited China before the COVID-19 pandemic to seek collaboration in this area, he recalls.

"Wang says both Hong Kong's and the mainland's organ donation rates still lag far behind those of developed economies. "They have reached a plateau and have made relatively adequate utilization of organ donations from the deceased. We have much room to develop in this regard."

"He says that while officials explore innovative approaches concerning living-organ donations, the priority should still focus on how to boost people's willingness to register as organ donors and better utilize the organs. "These are the so-called 'low hanging fruit'. It would be wise to concentrate our limited resources on the most rewarded option."

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"Execution by organ procurement: Breaching the dead donor rule in China," by Matthew P. Robertson, and Jacob Lavee in the AJT

 Prior to 2015, it was legal in China to transplant organs recovered from executed prisoners. When I visited China in those days to talk about kidney transplantation from living donors, it was sometimes pointed out to me that, as an American, I shouldn't object to the Chinese use of executed prisoner organs, because we also had capital punishment in the US, but we "wasted the organs."  I replied that in the US we had both capital punishment and transplantation, but were trying to limit one and increase the other, and that I didn’t think that either would be improved by linking it to the other.  

So here's a just-published retrospective paper looking at Chinese language transplant reports prior to 2015, which identifies at least some instances that it regards as "execution completed by organ procurement."

Execution by organ procurement: Breaching the dead donor rule in China, by Matthew P. Robertson1, and Jacob Lavee2, American Journal of Transplantation, Early View, First published: 04 April 2022 https://doi.org/10.1111/ajt.16969

1 Australian National University |  Victims of Communism Memorial Foundation, Washington, D.C., USA

2 Heart Transplantation Unit, Leviev Cardiothoracic Center, Sheba Medical Center, Faculty of Medicine, Tel Aviv University, Ramat Gan, Israel

Abstract: The dead donor rule is fundamental to transplant ethics. The rule states that organ procurement must not commence until the donor is both dead and formally pronounced so, and by the same token, that procurement of organs must not cause the death of the donor. In a separate area of medical practice, there has been intense controversy around the participation of physicians in the execution of capital prisoners. These two apparently disparate topics converge in a unique case: the intimate involvement of transplant surgeons in China in the execution of prisoners via the procurement of organs. We use computational text analysis to conduct a forensic review of 2838 papers drawn from a dataset of 124 770 Chinese-language transplant publications. Our algorithm searched for evidence of problematic declarations of brain death during organ procurement. We find evidence in 71 of these reports, spread nationwide, that brain death could not have properly been declared. In these cases, the removal of the heart during organ procurement must have been the proximate cause of the donor's death. Because these organ donors could only have been prisoners, our findings strongly suggest that physicians in the People's Republic of China have participated in executions by organ removal.

"how should we understand the physician's role in a context where executed prisoners are the primary source of transplant organs? Might the transplant surgeon become the de facto executioner? Evidence suggestive of such behavior has emerged over many years from the People's Republic of China (PRC).8-14 To investigate these reports, this paper uses computational methods to examine 2838 Chinese transplant-related medical papers published in scientific journals, systematically collecting data and testing hypotheses about this practice. By scrutinizing the clinical procedures around intubation and ventilation of donors, declaration of brain death, and commencement of organ procurement surgery, we contribute substantial new evidence to questions about the role of PRC physicians in state executions.

...

"The data we rely on in this paper involves transplant surgeries from 1980 to 2015. During this period, there was no voluntary donation system and very few voluntary donors. According to three official sources, including the current leader of the transplant sector, the number of voluntary (i.e., non-prisoner) organ donors in China cumulatively as of 2009 was either 120 or 130,30-32 representing only about 0.3% of the 120 000 organs officially reported to be transplanted during the same period (on the assumption that each voluntary donor gave three organs).18, 33, 34 The leader of China's transplant sector wrote in 2007 that effectively 95% of all organ transplants were from prisoners.35 According to official statements, it was only in 2014 that a national organ allocation system could be used by citizens.36

...

"Procuring vital organs from prisoners demands close cooperation between the executioner and the transplant team. The state's role is to administer death, while the physician's role is to procure a viable organ. If the execution is carried out without heed to the clinical demands of the transplant, the organs may be spoiled. Yet if the transplant team becomes too involved, they risk becoming the executioners.

"Our concern is whether the transplant surgeons establish first that the prisoners are dead before procuring their hearts and lungs. This translates into two empirical questions: (1) Is the donor intubated only after they are pronounced brain dead? And (2) Is the donor intubated by the procurement team as part of the procurement operation? If either were affirmative the declaration of brain death could not have met internationally accepted standards because brain death can only be determined on a fully ventilated patient. Rather, the cause of death would have been organ procurement.

...

"We define as problematic any BDD in which the report states that the donor was intubated after the declaration of brain death, and/or the donor was intubated immediately before organ procurement, as part of the procurement operation, or the donor was ventilated by face mask only.

...

"The number of studies with descriptions of problematic BDD was 71, published between 1980 and 2015. Problematic BDD occurred at 56 hospitals (of which 12 were military) in 33 cities across 15 provinces. 

...

"We have documented 71 descriptions of problematic brain death declaration prior to heart and lung procurement. From these reports, we infer that violations of the DDR took place: given that the donors could not have been brain dead before organ procurement, the declaration of brain death could not have been medically sound. It follows that in these cases death must have been caused by the surgeons procuring the organ.

"The 71 papers we identify almost certainly involved breaches of the DDR because in each case the surgery, as described, precluded a legitimate determination of brain death, an essential part of which is the performance of the apnea test, which in turn necessitates an intubated and ventilated patient. In the cases where a face mask was used instead of intubation48, 49—or a rapid tracheotomy was followed immediately by intubation,50 or where intubation took place after sternal incision as surgeons examined the beating heart44—the lack of prior determination of brain death is even more apparent.

"If indeed these papers document breaches of the DDR during organ procurement from prisoners as we argue, how were these donors prepared for organ procurement? The textual data in the cases we examine is silent on the matter. Taiwan is the only other country we are aware of where death penalty prisoners’ vital organs have been used following execution. This reportedly took place both during the 1990s and then once more in March 2011.51, 52

...

"The PRC papers we have identified do not describe how the donor was incapacitated before procurement, and the data is consistent with multiple plausible scenarios. These range from a bullet to the prisoner's head at an execution site before they are rushed to the hospital, like Tsai's description, or a general anesthetic delivered in the operating room directly before procurement. Paul et al. have previously proposed a hybrid of these scenarios to explain PRC transplant activity: a lethal injection, with execution completed by organ procurement. 

...

"We think that our failure to identify more DDR violations relates to the difficulty of detecting them in the first instance, not to the absence of actual DDR violations in either the literature or practice. Our choice to tightly focus only on papers that made explicit reports of apparent DDR violations likely limited the number of problematic papers we ultimately identified.

...

"As of 2021, China's organ transplant professionals have improved their reputation with their international peers. This is principally based on their claims to have ceased the use of prisoners as organ donors in 2015."

Vatican conference on organ trafficking and transplant tourism

A recent meeting at the Pontifical Academy of Sciences of the Vatican:
Summit on Organ Trafficking and Transplant Tourism resulted in a statement and a number of news stories.  Here are several that caught my eye, with divergent views on the situation in China and how it is changing:

From the NY Times: Debate Flares Over China’s Inclusion at Vatican Organ Trafficking Meeting
"China has admitted that it extracted organs from death row prisoners for decades, in what critics have called a serious violation of the rights of inmates who cannot give genuine consent. Since Jan. 1, 2015, Chinese officials have said they no longer use prisoners’ organs, though doubts persist.

“We urge the summit to consider the plight of incarcerated prisoners in China who are treated as expendable human organ banks,” wrote the 11 signatories, who included Wendy Rogers of Macquarie University in Australia; Arthur Caplan of the New York University Langone Medical Center; David Matas and David Kilgour, both Canadian human rights lawyers; and Enver Tohti, a former surgeon from the western Chinese region of Xinjiang."
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From Statnews.com
China moves to stop taking organs from prisoners, WHO says
"The World Health Organization says China has taken steps to end its once-widespread practice of harvesting organs from executed prisoners but that it’s impossible to know what is happening across the entire country.

At a Vatican conference on organ trafficking this week, a former top Chinese official said the country had stopped its unethical program, but critics remain unconvinced.

In an interview Thursday, WHO’s Jose Ramon Nunez Pena said he personally visited about 20 hospitals in China last year and believes the country has reformed. But he acknowledged that it was still possible “there may still be hidden things going on.” China has more than 1 million medical centers, although only 169 are authorized to do transplants.

Nunez Pena said he had seen data including organ transplant registries and was convinced the country was now shifting away from illegally harvesting organs.

“What is clear to me is that they’re changing,” he said. “But in a country as huge as China, we can’t know everything.”
...
"Campbell Fraser, an organ trafficking researcher at Griffith University in Australia, agreed the trends over the past few years have shown a drop in the number of foreigners going to China for transplants and an increase of organ seekers heading to the Middle East.

At a press conference at the Chinese Embassy in Italy following the two-day Vatican organ conference, Fraser said migrants — including Syrians, Somalis and Eritreans — sometimes resort to selling off a kidney to pay traffickers to get them or their families to Europe.

“Egypt is where the biggest problem is at the moment,” he said, adding that it has the best medical facilities in the region and can perform the live donor surgeries.

He estimated as many as 10 such illicit transplants could be happening per week, though he had no statistics and said he based his research largely on anecdotal information from recipients, law enforcement, doctors and even some organ “brokers.”

Fraser said he has access to transplant patient “chat boards” because he himself had a kidney transplant in his native Australia in 2003.

Nunez Pena said it was likely that organ trafficking would find its way to conflict-plagued regions.

“We’re hearing about a lot of problems in Egypt, Pakistan and the Philippines,” he said, predicting that authorities were poised to break up an organ smuggling ring in Egypt in the next few weeks. “Wherever you have vulnerable people, you will see these kinds of problems.”

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From Science:

Study retraction reignites concern over China’s possible use of prisoner organs

By Dalmeet Singh ChawlaFeb. 6, 2017 , 4:15 PM

A journal has decided to retract a 2016 study because of concerns that its data on the safety of liver transplantation involved organs sourced from executed prisoners in China. The action, taken despite a denial by the study’s authors that such organs were used, comes after clinical ethicist Wendy Rogers of Macquarie University in Sydney, Australia, and colleagues authored a letter to the editor of Liver International on 30 January, calling for the paper’s retraction in the “absence of credible evidence of ethical sourcing of organs.”

For years, Chinese officials have come under fire for allegedly allowing the use of organs from executed prisoners for transplants, including for foreigners coming to the country for so-called medical tourism. In January 2015, it explicitly banned the practice and set up a volunteer donation system, but doubts persist that much has changed.

The disputed study—published online in October 2016—analyzed 563 consecutive liver transplantations performed before the ban (from April 2010 to October 2014) at a medical center in China. Suspicious, Rogers organized the protest letter to the journal. “Publication of data from prisoners is ethically inappropriate given that it [is] not possible to ensure that the prisoners freely agreed either to donate their organs, or to be included [in] a research program,” she tells ScienceInsider.

Statement of Policy Principles and Solutions: Living Organ Donation, from the American Association of Kidney Patients (AAKP), the American Society of Transplant Surgeons (ASTS), and the American Society of Transplantation (AST)

 Here's a joint statement about living-donor kidney transplantation from the American Association of Kidney Patients (AAKP), the American Society of Transplant Surgeons (ASTS), and the American Society of Transplantation (AST). The statement opposes rethinking the ban on compensation for donors, suggests that other policies should be evidence-based, and opposes increased bureaucratization and cumbersome regulation of the transplant process.

Statement of Policy Principles and Solutions:  Living Organ Donation

"We stand together in our conviction that any policy changes impacting living organ donation, including those aimed at improving access to living donor transplantation and increasing the survival of already transplanted patients, must begin with principled and transparent dialogue with patients and the expert transplant teams who care for them.  

...

"The United States ranks in the top tier of nations in terms of living donor transplant rates,[1] meaning the current system for living donation works. However, disparities in access to living donor transplantation remain, and we must continue to improve and expand living donor transplantation for those in need.  As such, we support policy changes that are patient-centric, fiscally realistic, and ethically and legally sound. 

"Over the past decade some well-intended organizations and advocates have advanced ideas to increase access to living donor transplantation, including direct payments for or large financial incentives for organ transplants, that may appear expedient but can result in serious adverse consequences for transplantation and for patients. Many of these proposals pose serious unintended negative consequences to both donors and to public trust in organ donation. We fundamentally reject efforts to model changes to the current US system based on research or organ transplant practices in nations such as China and Iran whose governments fail to meet or ignore high international and US standards for ethical medical research and basic human rights.

...

"AAKP, ASTS, and AST strongly support the elimination of disincentives to transplantation and adamantly oppose coercive financial incentives to donate.

...

"AAKP, ASTS, and AST believe that improvements to the transplant system can best be made through ethically and legally sound, evidence-based, data driven policies informed and guided by patients and transplant professionals rather than by overhauling the entire transplant system.

"The transplantation system is a public-private partnership between the federal government and the transplant community and is designed, in part, to prevent overt political influence or other governmental interference in shared patient-physician decision making and clinical judgement. The relationship between patients, including living organ donors, and the doctors and medical institutions they choose to care for them must be protected and respected, as should the ability of individual transplant professionals to make clinical decisions in the best interest of those patients.

"Transplantation is heavily regulated by multiple federal agencies, including the Centers for Medicare and Medicaid Services (CMS), the Health Resources Services Administration (HRSA), and two HRSA contractors (the Organ Procurement and Transplantation Network (OPTN) and the Scientific Registry of Transplant Recipients (SRTR)).  Transplant centers are subject to duplicative (and often conflicting) requirements and surveys imposed by CMS and the OPTN. Living donor transplant programs are subject to additional scrutiny to ensure that donors are not pressured, coerced, or intimidated into donating an organ.  All living donor transplant programs are required to have independent living donor advocates that ensure that donors’ full and informed consent is given with a full understanding of the procedure and its potential risks and consequences.

"Into this existing and complex regulatory framework, some organizations are proposing policy and legislative changes that would either expand federal control over transplant by inserting yet another federal agency into the process or overhauling the entire transplant system to give federal agencies, as well as political appointees and politicians, greater authority to regulate living donor transplantation. Exposing the living organ donation system to such political influence and putting decision-making in the hands of non-transplant experts is a mistake with dangerous consequences for patient health, public trust, and donor and patient confidence.

"These proposals raise the possibility that the federal government would mandate a “one-size fits all approach” to an incredibly complex set of clinical problems. Such an approach would likely result in fewer innovations and fewer opportunities to reduce barriers to transplantation, especially for historically underserved communities. There are many potential reforms to the transplant system that can be effective, have been suggested by the wider transplant community over the past decade, and should be adopted by Congress and federal agencies. However, any policy or legislative proposal that seeks to amend or replace the existing system with an even larger federal bureaucratic reach with the potential for federal interference in decisions made among organ donors and patients and the doctors and medical institutions they choose to receive care from should be viewed with skepticism.

"We oppose policy efforts that seek to place any governmental entity in the position of determining clinical criteria for living donor transplantation or otherwise interfering with the relationship between and among potential recipients, potential donors, and their caregivers.

*******

As a reader of many such joint statements, I wonder if the phrase  "coercive financial incentives" resulted from a compromise between those who believe that all financial incentives are coercive, and those who wish to leave the door open in the future to ordinary, non-coercive financial incentives, of the kinds that attach to so many human activities, and have done so much to relieve other kinds of shortages.

HT: Laurie Lee via Frank McCormick

Frank Delmonico and the recent organ transplant meeting at the Vatican

When I was in Trento, I participated in a panel on markets for human organs, and had the chance to ask Dr. Ignazio Marino about the recent

Vatican statement on organ transplantation, which I pointed out seemed to conflate killing prisoners for their organs with much more ordinary attempts to increase voluntary organ donation.  Dr Marino replied that this had been part of the diplomacy involved with the Chinese delegation.

Here's an article about the backstory to some of that diplomacy, and the role played by my old friend Frank Delmonico

One doctor’s war against global organ trafficking
By Ryan Connelly Holmes And Dan Sagalyn May 29, 2017

"A controversy was brewing. Delmonico, a leading voice on ethical organ transplantation, had planned a February 2017 summit in Rome for representatives of more than 40 countries to discuss the ethics of transplanting organs and to sign a pledge to uphold high standards.

"But there was a hitch: A key invitee to the forum was Dr. Jiefu Huang, who has led reform of China’s organ donation practices. Critics, including some in the Vatican, wanted at the summit no representatives of China, which for years sold and transplanted organs from executed prisoners.

"Delmonico, however, saw the Chinese presence as a good thing. It was “an opportunity for them to proclaim a new day and be accountable” that the practice has stopped, he said. In fact, some of the Chinese old guard have attacked Huang because of his efforts to stamp out unethical and corrupt methods of obtaining organs.
...
"Pope Francis did not attend, but Marcelo Sánchez Sorondo, the chancellor of the Pontifical Academy of Sciences did. In a significant development, China signed the summit’s statement condemning the use of organs from prisoners and advocating the creation of national laws to prosecute transplant-related crimes. Beijing’s two delegates were joined by 75 other signatories representing more than 50 institutions and more than 40 nations at the conference. Delmonico called it a “seminal event” in the fight for global reform."
**********


I hope that this effort at diplomacy, aimed at ending the practice of using executions as the primary source of organs in China, will not be a source of confusion regarding attempts to increase the availability of organ transplants by ethical means.

Kidney transplantation in China

In China Daily: Kidneys illegally sold online

"Two major online forums www.02066.com.cn and www.as.2sun.cn, are operating for organ brokers in dozens of cities across the country, including Beijing, Tianjin, Zhengzhou and Shangqiu in Henan province, Hangzhou in Zhejiang province, Dongguan in Guangdong province, Changchun in Jilin province and Hefei in Anhui province.

...Ministry of Health officials said the trade in human kidneys is illegal, and pointed to the creation of a new database that has been designed to make organs available to the approximately 1 million Chinese waiting for transplants. The database began as a pilot project in some areas, including Shanghai, in September.

...Chen Shi, a professor in medicine at Huazhong University of Science and Technology, said the illegal trade must be banned to protect people's rights. "


Meanwhile, the American Journal of Transplantation has this to say:

"China's Vice Minister of Health, Huang Jiefu, MD, and the English-language newspaper China Daily announced in late August that China has established new national organ donation system to increase consented donors, halt rgan trafficking and quell the long-time dependence on use of organs from executed prisoners.1 A pilot project for the system, which will be operated mainly by the Red Cross Society of China with assistance from the Ministry of Health, will begin in 10 provinces and cities.
Within the China Daily article Dr. Huang says that prisoners, whom experts estimate account for more than 65% of total donors, "are not a proper source for organ transplants," nor should transplantation be a privilege for the rich.
Noting that "the candid observation by the Vice Minister is courageous and commendable," Francis L. Delmonico, MD, director of medical affairs for The Transplantation Society, advisor for human transplantation for the World Health Organization and a Harvard professor of surgery, says the concern of the international community regarding the recovery of organs from executed prisoners is that the need for organs has fueled the need, or demand, for executions. "The expectation that a foreign patient can undergo transplantation in China on a specified date—with blood type compatibility—brings that concern to a reality," he adds. He also says the international community, as represented by the Istanbul Declaration, supports the intention of China to establish a deceased donation system.
Statement From The Transplantation Society
While we can see some 'green shoots' of a new and ethical transplant program focused on meeting the needs of the Chinese community with end-stage organ failure, there is a long way still to go. There is no doubting that the Chinese Government in Beijing is determined to curtail the grisly trade in executed prisoners, so it seems mostly to have gone underground and a new trade in commercial living kidney and liver transplantation appears to be springing up. The Transplantation Society remains in contact with many people throughout China and is committed to helping to encourage these new signs of appropriate use of transplantation therapy, while remaining steadfast in opposition to the sale of organs to rich foreign patients.
—Jeremy Chapman, MD, president, The Transplantation Society"

In Taiwan, most registered organ donors are women

Women far more willing to donate organs, numbers show

"Taipei, Aug. 25 (CNA) Of the 620,000 people on Taiwan's organ donation list, 65 percent are women, which one expert says proves woman have bigger hearts than men.

"Wu Ying-lai, secretary general of the Republic of China Organ Procurement Association, made the remarks as her association released a report on trends in local organ donation to mark its 20th anniversary on Sunday.

"The trend is more pronounced in the largest demographic of organ donors, those aged 21-50, which features 2.2 times more women than men, Wu said, based on an analysis of the 223,250 people who have signed up for the national organ donation program in the past 10 years.

"Looking at the data more closely, the largest groups of donors are women aged 31-40, followed by women aged 41-50, women aged 21-30, men aged 31-40, and men aged 41-50, she noted."

President Trump's Executive Order on kidney care

On July 10, while I was in China, President Trump issued an executive order touching on all aspects of care for kidney patients, including dialysis and transplantation from both deceased and living donors.

Here's the text of that executive order:
Executive Order on Advancing American Kidney Health
 Issued on: July 10, 2019

Because I anticipated being potentially incommunicado when the executive order was announced, I had filed an op-ed article (giving my proxy to my coauthor Greg Segal for any necessary last-minute edits) to be published on CNN's web site, applauding the order:
The Trump administration's organ donation efforts will save lives
By Alvin E. Roth and Greg Segal
Updated 1:20 PM ET, Wed July 10, 2019

As it happens, a reporter for PBS news hour reached me by phone in China, and so I got to chime in in person:
Trump’s plan to combat kidney disease aims to save money and lives. Can it?
Health Jul 10, 2019 4:39 PM EDT


The part of the executive order that touches most closely on my work on kidney exchange is Section 8:

"Sec. 8.  Supporting Living Organ Donors.  Within 90 days of the date of this order, the Secretary shall propose a regulation to remove financial barriers to living organ donation.  The regulation should expand the definition of allowable costs that can be reimbursed under the Reimbursement of Travel and Subsistence Expenses Incurred Toward Living Organ Donation program, raise the limit on the income of donors eligible for reimbursement under the program, allow reimbursement for lost-wage expenses, and provide for reimbursement of child-care and elder-care expenses."

Regarding deceased donor transplants, Section 7 says

"Sec. 7.  Increasing Utilization of Available Organs.  (a)  Within 90 days of the date of this order, the Secretary shall propose a regulation to enhance the procurement and utilization of organs available through deceased donation by revising Organ Procurement Organization (OPO) rules and evaluation metrics to establish more transparent, reliable, and enforceable objective metrics for evaluating an OPO’s performance.

(b)  Within 180 days of the date of this order, the Secretary shall streamline and expedite the process of kidney matching and delivery to reduce the discard rate.  Removing process inefficiencies in matching and delivery that result in delayed acceptance by transplant centers will reduce the detrimental effects on organ quality of prolonged time with reduced or cut-off blood supply."

***************

Here is some of the news coverage:

Trump signs executive order revamping kidney care, organ transplantation By Lenny Bernstein July 10 (Washington Post);
Trump signs executive order to transform kidney care, increase transplants 
By Jen Christensen and Betsy Klein, CNN Updated 4:21 PM ET, Wed July 10, 2019

This executive order is well worth supporting, and it will need support to achieve the goals it outlines.  The Secretary of Health and Human Services has been directed to do things in fairly broad terms, and we'll have to watch carefully to see the results, which will be interpreted, contested, and implemented through multiple political/regulatory processess

*************

Regarding removing financial disincentives for kidney (and liver) donors, I'm on the advisory board of the federally funded National Living Donor Assistance Center (NLDAC), which has been able, under very tight constraints, to reimburse some donors for some travel expenses (see related posts here).  A minimalist interpretation/implementation of the Executive Order would be to relax some of the constraints on whose expenses and which expenses can be reimbursed, and to increase NLDAC's budget accordingly.  A more expansive interpretation would be to remove some of those constraints so that no donor would have to pay to rescue someone with kidney failure by donating a kidney.

China, transplants, and executed prisoners: is the situation getting clearer?

A recent meeting in China cautiously suggests that there may be some concrete change in the practice of transplanting organs from executed prisoners:
Doctors hail China’s pledge to stop harvesting inmate organs

"Doctors from the World Health Organization and the Montreal-based Transplantation Society who were invited to the conference by China praised Chinese officials for reforms they have made in the transplant system, including a ban put in place last year on using organs from executed inmates.

"Doubts persist that China is accurately reporting figures or meeting its pledge given its severe shortage of organ donors and China’s long-standing black-market organ trade. By its own figures, China has one of the lowest rates of organ donation in the world, and even the system’s advocates say it needs hundreds of additional hospitals and doctors.

"While China suppresses most discussions about human rights, government officials and state media have publicly talked about their commitment to ending a practice opposed by doctors and human rights groups due to fears that it promotes executions and coercion.
...
"Others offered praise for Chinese officials, but stopped short of saying whether they could confirm China had stopped using executed inmates’ organs.

“It’s not a matter for us to prove to you that it’s zero,” said Dr. Francis Delmonico, a longtime surgeon and a professor at Harvard Medical School. “It’s a matter for the government to fulfill what is the law, just as it is in the other countries of the world that we go to.”

"China is believed to perform more executions than any other country, though the government does not disclose how many.

"The former vice minister of health, Dr. Huang Jiefu, publicly acknowledged in 2005 that China harvested executed inmates’ organs for transplant, and a paper he coauthored six years later reported that as many as 90 percent of Chinese transplant surgeries using organs from dead people came from those put to death.

"Huang has also responded to a report earlier this year that a Canadian patient apparently received a kidney from an executed inmate by announcing that the doctor and the hospital in question were suspended from performing more transplants."

Organ transplants and capital punishment don't go well together

 I recently blogged about a paper by Robertson and Lavee in the American Journal of Transplantation, looking at surgeries conducted in China before 2015, a period in which China acknowledged that most transplants there were conducted with organs from executed prisoners.  Now they summarize their report in a column in the WSJ.

In China, New Evidence That Surgeons Became Executioners. Clinical reports recount scores of cases in which organ donors were alive when operations began.  By Jacob Lavee and Matthew P. Robertson

"The Wuhan doctors write: “When the chest of the donor was opened, the chest wall incision was pale and bloodless, and the heart was purple and beating weakly. But the heartbeat became strong immediately after tracheal intubation and oxygenation. The donor heart was extracted with an incision from the 4th intercostal sternum into the chest. . . . This incision is a good choice for field operation where the sternum cannot be sawed open without power.”

"By casually noting that the donor was connected to a ventilator (“tracheal intubation”) only at midsurgery, the physicians inadvertently reveal that the donor was alive when the operation began.

...

"Our findings end in 2015, but we think the abuse likely continues. Medical papers like those we studied were first unearthed by Chinese grass-roots investigators in late 2014, and it would have been simple to command journals to stop publishing the incriminating details after that. While China claims to have stopped using prisoners in 2015, our previous research raises doubts. In a 2019 paper in the journal BMC Medical Ethics, we used statistical forensics to show that the official voluntary-organ donation numbers were falsified, inflating the success of a modest voluntary organ-donation reform program used to buttress the reform narrative.

"Global medical leaders have largely dismissed such concerns. The World Health Organization took advice from Chinese transplant surgeons in the establishment of its anti-organ-trafficking task force—and then installed them on the membership committee. In 2020, WHO officials joined long-time apologists for China’s transplant system, attacking our previous research showing falsified numbers."

...

"Dr. Lavee is the director of the Heart Transplantation Unit at Tel Aviv’s Sheba Medical Center and a professor of surgery at Tel Aviv University. Mr. Robertson is a research fellow with the Victims of Communism Memorial Foundation and a doctoral candidate in political science at the Australian National University."

Organ markets, transplant tourism, and compensation of donors in Asia

The Australian ABC News carries a story about transplant tourism that seems to focus on China (but which I hope is a little dated): Australian organ tourists drive sinister trade
One of the disturbing (hearsay) quotes: ""I know of one patient who was heading for a country overseas; told the unit that they would be unable to come in for dialysis tomorrow because they were shooting her donor tomorrow."

The story quotes one Australian surgeon as suggesting that relying primarily on deceased donors would be preferable, since there is less room for an illegal market to creep in (maybe the reporter didn't read him the quote above).  Australia, like everywhere else in the world, doesn't have enough deceased donor kidneys to meet demand, and live donor transplantation continues to outperform deceased donor transplantation (hence kidney exchange). Stories like this make me worry about babies being thrown out with bathwater...

A recent paper discusses the organ trade in Asia, and policies regarding legal compensation of donors: , Living Organ Transplantation Policy Transition in Asia: towards Adaptive Policy Changes by Alex He Jingwei, Allen Lai Yu-Hung, and Leong Ching, in Global Health Governance, Volume III, Issue 2: Spring 2010.
The authors are all Ph.D. candidates at the Lee Kuan Yew School of Public Policy, National University of Singapore.

"This paper surveys trends in ten Asian economies and highlights the gradual loosening of restrictions on donor eligibility and compensation. We suggest that one explanation for those cases which have remained unchanged in their transplantation policies is the existence of a thriving trans-boundary organ trade, which although
ethically indefensible, is tolerated by pragmatic policymakers."
...
"...Saudi Arabia has changed its policy. According to the World Health Organization (WHO), a law passed in Saudi Arabia in October 2007 envisages that the government pays a monetary “reward” of 50,000 riyals (US$13,300) and other benefits, including life-time medical care, for unrelated organ donors in a system regulated at the national level. The law’s supporters said it would stop Saudi citizens from travelling to China, Egypt, Pakistan, the Philippines, and other countries to receive organ transplants.30 The effect of this new policy is immediate—Saudi Arabia quadrupled its rates of living kidney donation within a short period, ranking no. 1 today.31
"Singapore has faced a persistent shortage of organs for donations too. As of October 31, 2008, there were about 520 people on the kidney transplant waiting list. The average waiting time is nine years. Religious customs, cultural norms, and a fear of transplant operations have been cited as reasons for the donor shortage. Given its small population, and level of affluence, it is perhaps natural that this country will eventually find some ways to regulate this de facto market. The most recent of these has been an amendment to the “Human Organ Transplant Act” (HOTA) to allow compensation to donors. At the same time, it has also increased the penalty for organ trading, signaling that a complete price mechanism is unacceptable.
"HOTA originally prohibits the giving or acceptance of organs under a “contract of arrangement” which precludes organ trading. In November 2008, the Ministry of Health (MOH) proposed that paired matching for exchange of organs be allowed in Singapore to increase the chances of improved transplant outcomes and to save more lives. Under this arrangement, patients can essentially switch donors. The MOH sees this as creating matches that may otherwise have not occurred, as well as others that are medically compatible for improved clinical outcomes.
"A more radical change is to allow compensation to be made to living donors in Singapore. At the time of writing, this amendment has already been passed in the parliament, and the MOH is working out compensation levels. Under the law, provision is made for direct costs incurred as a result of the donation, as well as indirect losses such as lost earnings and future expenses due to the donation. In order to control the financial incentive, all the reimbursements will be credited to the donors’ medical savings accounts instead of cash transfers."

HT: Joshua Gans and Sally Satel

Organ sales in China

MSNBC reports Organ trafficking trial exposes grisly trade: Chinese man accused of selling black market body parts
"China in 2007 banned organ transplants from living donors, except spouses, blood relatives and step or adopted family members, but only launched a national system to coordinate donation after death last year.
Its efficiency has yet to be proved. Nearly 1.5 million people in China need organ transplants each year, but only 10,000 can get one, according to the Health Ministry.
The defendants in the two Beijing trials face up to five years for their role as go-betweens between donors and buyers, which could "damage society and moral values", the Procuratorial Daily reported. They are still waiting for their verdict.
But at least two of them say they are being unfairly hounded for playing a vital role in helping both the sick and poor.
"I believe I was helping people, not harming others," the paper quoted defendant Liu Qiangsheng as saying.
Liu says he got into the business after selling half his own liver in 2008 to help pay for this father's medical bill. A friend of the recipient, who was waiting in despair for a liver, asked him to find another organ provider.
"I saved the life of the person who received my liver. He was only in his 30s. I do not regret it," he said.
His partner, Yang Shihai, had also sold one of his own kidneys, the paper reported.
"The donors were free. They were not controlled by us. They sold their organs voluntarily," it quoted Yang saying.
Middlemen specialized in faking documents allowing donations between strangers have helped raise transplants from living donors to 40 percent of donations, from 15 percent in 2006, the official China Daily reported last year.
However the majority of organs for transplant are still harvested from executed criminals, the paper said. Beijing hopes the new system will end both live transplants and taking organs from prisoners, which makes senior officials uncomfortable.
"(Executed prisoners) are definitely not a proper source for organ transplants," Vice Minister Huang Jiefu told China Daily."

An incongruous note: In the middle of the story was an ad saying "Buy 1 Get 1 Free." (It turned out to be an ad for eyeglasses...)

In defense of pilot studies for organ donor incentives

The third in the series of forthcoming AJT papers about incentives/disincentives for donation discusses the basis for pilot studies (see earlier posts 1 and 2)

Between Scylla and Charybdis: Charting an Ethical Course for Research Into Financial Incentives for Living Kidney Donation
J. S. Fisher1, Z. Butt, J. Friedewald, S. Fry-Revere, J. Hanneman, M. L. Henderson, K. Ladin, H. Mysel, L. Preczewski, L. A. Sherman, C. Thiessen andE. J. Gordon*
Article first published online: 31 MAR 2015
DOI: 10.1111/ajt.13234

"The transplant community appears to be in a state of equipoise regarding the ethical soundness of empirically investigating a regulated system of financial incentives for living kidney donation. ...Proponents of financial incentives for nondirected living donors posit that incentives would increase the supply of high quality organs, prolong quantity, improve quality of life of recipients, and offset the societal cost by reducing the patient population receiving dialysis [10, 11]. Opponents argue that financial compensation beyond recovering expenses would: (1) cause undue pressure to donate, (2) exploit at-risk individuals (such as the poor), (3) commodify the human body, (4) exacerbate disparities in access to transplants between different socioeconomic strata, and (5) negatively impact public opinion and potentially lead to decreased organ donation rates [12, 13]. However, the debate over the intended and unintended effects of a federally regulated system of financial incentives in the United States remains unresolved partly due to a lack of empirical data.

Critics commonly turn to national programs outside the United States (e.g. India, China, Philippines, Eastern Europe) where black market incentives are the rule to justify concerns that financial incentives are exploitative of living donors. We do not disagree that paying donors illegally is exploitive. Other countries like Israel, Saudi Arabia, Iran, Singapore, and Ireland, however, have implemented legal compensation policies that assist living kidney donors to varying degrees and with varying success. However, these programs developed organically without extensive transparency or oversight, rather than as part of a prospective study designed with embedded outcome measures. Thus, it is unclear whether the successes of such policies are translatable to the US context given the differences in our governmental, medical, and societal infrastructures. Until rigorous, relevant data are properly collected, there is no way to determine whether concerns are warranted about potentially adverse effects of financial incentives on patient safety, exploitation, autonomy, and public trust as part of a US federally regulated system.

Members from several academic and professional organizations have called for pilot studies to investigate the provision of financial incentives to eligible living kidney donors to increase donation rates [14-17]. Logistical parameters for such studies have been suggested [18, 19]. However, while proposals for pilot studies commonly advance arguments for financial incentives, they have not systematically addressed the ethical concerns raised by opponents of a pilot study. This paper provides an ethical justification for conducting a pilot trial to study the feasibility and impact of a federally regulated system utilizing financial incentives on living kidney donation rates.''
...
in conclusion...
"the first step to resolve equipoise will require one or more carefully designed pilot studies to assess individual perceptions to determine if a course can be charted between exploitation and undue influence. Only such pilot studies can inform the transplant community as to whether larger, randomized controlled trials may be ethically undertaken to determine if ultimately, a federally regulated financial incentives program could feasibly and effectively increase living kidney donation rates without living donors incurring perceptions of negative psychological experience or generating negative public reaction.

Ohio execution stay for Ronald Phillips for possible organ donations

This will complicate my discussions in China...

Ohio execution stay for Ronald Phillips for possible organ donations

November 14, 2013 (COLUMBUS, Ohio) -- Ohio's governor delayed the execution of a condemned child killer to consider the inmate's unprecedented organ donation request, acknowledging that it's ''uncharted territory'' but expressing hope that the man might help save a life before losing his own.

Ronald Phillips, 40, was scheduled to be put to death Thursday with a lethal injection of a two-drug combination not yet tried in the U.S., but Gov. John Kasich issued a stay of execution Wednesday. The execution date has been reset for July 2.

"I realize this is a bit of uncharted territory for Ohio, but if another life can be saved by his willingness to donate his organs and tissues then we should allow for that to happen," Kasich said in a statement. He said he wanted to allow time for medical experts to study whether Phillips could donate non-vital organs, such as a kidney, before being executed.

Related Content

STORY: Organ-donor request delays Ohio killer's execution

Phillips, who was sentenced for raping and killing a 3-year-old girl in Akron in 1993, asked this week to donate a kidney to his mother and his heart to his sister. His attorney said it was an attempt to do good, not a delay tactic.

Ohio's prison medical policy accommodates organ donations, but prison officials rejected the request, saying it came too late to work out logistics and security concerns.

Kasich said Phillips' crime was heinous but his willingness to donate organs and tissue could save another life and the state should try to accommodate that.

Some 3,500 people in Ohio and more than 120,000 nationally are awaiting organ donations, said Marilyn Pongonis, a spokeswoman for the Lifeline of Ohio organ donation program.

If Phillips is a viable donor for his mother, who has kidney disease and is on dialysis, or for others awaiting live transplants of non-vital organs, the stay would allow time for those procedures to be performed, Kasich said.

Phillips' sister suffers from a heart ailment and he also wants to donate his heart to her.

Richard Dieter, executive director of the Death Penalty Information Center, said a Delaware death row inmate was permitted in 1995 to donate a kidney to his mother while in prison, though he was not facing imminent execution like Phillips.

"This step by the governor puts it into a more normal discussion of (how) an inmate, without any security problems, can help save another person and is that the right thing to do," he said. "With 24 hours to go before an operation had to be carried out, it definitely gets in the way of that process."

Vital organ donations raise larger ethical issues and have not been allowed during U.S. executions but have occurred in China, Deiter said.

Dieter, whose group opposes the death penalty, added: "If the whole idea is to save a life, there's one life to be saved simply by not executing the person at all."

Phillips made his request after the governor denied him mercy and Phillips had exhausted his other legal options. The state had left it up to Phillips' family whether the organs would be harvested after his death.

HT: Bernadette Keller

Transplantation in China: update

I returned Sunday from a busy and potentially productive trip to China.

Since 2015 it has been illegal in China to use organs from executed prisoners for transplants. The passage of that law was the result of a long struggle between an opaque, often black market system of transplantation, and an emerging transparent system based on voluntary donation.  The transparent system has made, and is continuing to make, enormous strides.

In Shenzhen I visited the China Organ and Transplant Response System (COTRS), run by Dr. Haibo Wang, which organizes and records the data of transplant patients and donors. 

It also collects large amounts of data on all hospital stays at China’s largest hospitals. Together with the National Institute of Health Data Science at Peking University, run by Dr. Luxian Zhang, they are assembling a vast data resource that will have many uses.

In Beijing I also visited the China Organ Transplant Development Foundation, run by Dr. Jeifu Huang, which plays a role in guiding the emerging body of legislation through which transplants are being organized in China with increased transparency.

I also spoke at the Beijing Summit on Health Data Science.

It was a busy week that left me optimistic that we'll see continued big progress in healthcare delivery in China, including but not limited to transplantation.

Some photos were taken...