Ethical problems highlighted by transplant operations using disease-affected kidneys conducted by the Tokushukai Group, which runs hospitals nationwide, sparked wider discussions on transplants.
On July 5, the Health, Labor and Welfare Ministry's council on advanced medical treatment (see below) formally approved such transplants, with conditions, as an advanced medical treatment that can be performed as an exception together with medical treatment covered by the public health insurance scheme.
This conclusion was reached after more than eight years of deliberation over this treatment's propriety, a process that included opposition by advocates of the mainstream view on transplantation therapy.
However, the nation's severe donor shortage remains unchanged, and some observers say "fundamental measures are needed" to rectify this situation.
Securing transparency
At the meeting of the council that approved transplants using disease-affected kidneys, Chairman Nobuyuki Miyasaka again emphasized the need to ensure the process was transparent.
"Will selection of the donor and recipient be done fairly and openly and the process move ahead in a manner acceptable to all?" Miyasaka asked.
In the public gallery, Tokushukai officials and patients supporting transplants using disease-affected kidneys leaned forward as they carefully listened.
The approved treatment involves removing the cancer from a donor kidney and transplanting the healthy remaining part into a person suffering from kidney failure. The kidney is provided by a third-party donor, not a patient's family member.
Tokyo Nishi Tokushukai Hospital in Akishima, Tokyo, and Uwajima Tokushukai Hospital in Uwajima, Ehime Prefecture, plan to perform a total of 42 such transplants over the next four years.
The issue of transplants using disease-affected kidneys came to light in 2006, following revelations that a patient at the Uwajima Tokushukai Hospital had undergone a kidney transplant after paying for the organ.
This violated guidelines set by the Japan Society for Transplantation, and there were further revelations that the kidney was provided by a third party who was not a relative and that there was no screening by an ethics committee. Following this incident, public distrust of diseased kidney transplantation became widespread.
An investigation later concluded the hospital did not do enough to ensure the patient could give informed consent to the operation. This sparked a flurry of furious criticism from many quarters. "Medically, going ahead with that should be impossible," said a senior official of the transplantation society, which champions the mainstream view on medical transplantation.
The only option for some
Even so, the fact remains that this is the only available option for some people waiting impatiently for a transplant.
"The path to helping these patients opened slightly. This gives hope to people who have yet to find a donor," said Yoji Mukoda, who heads a group of patients who support transplants using disease-affected kidneys and campaigns for greater understanding of transplant issues.
The patients' ardent feelings have even driven them to file lawsuits on the matter. In 2008, members of the group filed a suit demanding damages from a senior official of the Japan Society for Transplantation for what they claimed were infringements on their right to live and right to choose their medical treatment. In 2016, the plaintiffs' loss in this case was finalized.
Against a backdrop of support from some patients, Tokushukai resumed transplants using disease-affected kidneys as "clinical research" in December 2009. Of the 13 transplants performed, none resulted in the onset of cancer in recipients.
Five years after the transplants, at least seven of the kidneys were functioning normally. After performing nine transplants using kidneys from people who were not relatives of the recipients, in October 2011 the group applied to have the method adopted as an advanced medical treatment.
Five medical societies opposed this and demanded the government proceed very carefully before making a decision. Consequently, discussions of the issue became bogged down. A decision was postponed and Tokushukai reapplied several times for approval.
Aside from the sparring over the use of disease-affected kidneys, doctors have performed liver and lung transplants using unhealthy organs. Amid a severe donor shortage, these transplants are approved as a last-ditch measure provided the patient is fit to undergo the operation and there are no problems with the informed consent process.
Among surgeons who perform such transplants using diseased kidneys, there is a growing view that, provided all the conditions are met, there is medically no reason why they should refuse to do such operations.
Long path to wider acceptance
However, the practice of this medical treatment will not greatly change the environment surrounding patients waiting for a transplant.
One of the requisites for being a donor of a disease-affected kidney for transplant approved as an advanced medical treatment is that the organ must not have an individual tumor measuring more than seven centimeters across.
With a small tumor, the potential donor's cancer treatment method is more likely to involve removing the affected part, rather than taking out the entire kidney. Consequently, securing enough "disease-affected kidneys" is said to be difficult, a point raised again at the council meeting. The possibility that the transplanted kidney could become cancerous again also cannot be ruled out.
According to the Japan Society for Transplantation and other sources, transplants using disease-affected kidneys are performed overseas, although only in a few cases. In Australia, it was reported that 10 out of 43 such cases involved benign tumors that actually did not need to be removed.
Approval of a treatment as an advanced medical treatment is usually made with a view to having the procedure covered by the public health insurance scheme in the future. However, many potential obstacles remain in the way to making disease-affected kidney transplants more common.
The council stated that if such treatment is to come under insurance coverage, ensuring the transparency of this type of medical care will be "indispensable."
The two Tokushukai hospitals plan to accept an external committee member dispatched by medical societies concerning kidney transplantation, and to submit detailed reports to the central government and the societies. The thorough disclosure of information will be necessary to dispel public distrust in this medical practice.
Over 14-year waiting list
The nation's severe donor shortage has once again come into the spotlight.
As of the end of April, about 11,900 people wanting kidney transplants were registered with the Japan Organ Transplant Network. However, only about 170 kidneys become available for transplant from brain-dead and cardiac arrest donors each year.
According to the network, the average waiting time for a kidney transplant in Japan is about 14 years and eight months, and many people die while waiting for an organ to become available. A total of 3,649 such transplants have been performed so far -- a number eclipsed by the 3,955 people who have died while awaiting transplants.
Japan's low rate of organs provided for transplant is striking when compared with other nations. In 2017, 0.9 people per million in Japan donated organs. This was far below the rate of 46.9 people per million in Spain, 32.0 in the United States and 10.6 in South Korea.
"The extreme shortage of donors is undoubtedly a fundamental problem," said Prof. Takashi Kenmochi at Fujita Health University Hospital's Organ and Tissue Transplant Center. "We must do something to turn this situation around."
The domestic lack of organs supplied by dead people also has led to greater reliance on transplants from live donors, a situation uncommon in other nations.
According to the Japan Society for Transplantation, in 2016, doctors performed about 1,500 living donor kidney transplants that used one of a healthy donor's two kidneys.
Living donor transplants, which bring a risk to a healthy donor, are treated overseas as exceptional cases from an ethical standpoint.
"Giving official approval to disease-affected kidney transplants will expand the range of people able to become living donors for complete strangers. The government will need to tighten monitoring of the ethical aspects of these cases," said Jiro Nudeshima, a coleader of the Bioethics Policy Study Group, which studies organ transplants and life ethics.
(From The Yomiuri Shimbun, July 6, 2018)
--Advanced medical treatment
A system that allows new types of medical treatment not covered by the public medical insurance scheme, but approved after careful screening to be used in combination with medical care services that are covered under public health insurance. This system is not the same as "mixed medical treatment," in which a patient receives some medical care ordinarily subject to the public insurance scheme together with some care not covered by the scheme and must fully pay for the entire treatment from their own pocket. In mixed medical treatment, the patient shoulders a heavier financial burden because they must pay all the expenses, including for the portion ordinarily subject to the public insurance scheme.
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