'Risky' transplants to resume using disease-affected kidneys

[okarol]

'Risky' transplants to resume using disease-affected kidneys

Kunio Kohinata / Yomiuri Shimbun Staff Writer

Against the backdrop of a severe shortage of domestic organ donors, Tokushukai group, a nationwide hospital chain, plans to resume transplant operations using disease-affected kidneys.

Tokushukai has voluntarily refrained from this practice since 2006 in light of criticism about the potential risks to both donors and recipients.

Experts have pointed out that recipients run a high risk of developing cancer when receiving a kidney from a donor diagnosed with the disease, though Tokushukai rejects this claim.

Tokushukai's unique renal transplantation method removes organs from patients with such diseases as kidney cancer and aneurysms and transplants the organs into people with such kidney diseases as chronic nephritis. Tokushukai says kidneys are only removed when it is deemed vital to the health of kidney disease patients.

Tokushukai has not carried out this practice since February 2006, when a patient at Uwajima Tokushukai Hospital in Ehime Prefecture was revealed to have undergone a kidney transplant there by paying for the kidney of an acquaintance in violation of the Organ Transplant Law. Paying for organs and receiving payment for organs are both illegal under the law.

Police investigations revealed that the hospital's head doctor, Makoto Mannami, had transplanted disease-affected kidneys into 42 people since 1991.

Mannami subsequently came under fire from many experts, including members of the Japan Society for Transplantation.

He was denounced for two major reasons: for transplanting disease-affected kidneys that potentially could cause cancer; and giving neither donors nor recipients a detailed explanation before the transplants and failing to get written agreements from them prior to the procedure.

The JST, which has about 3,800 members across the country, released a statement in 2007 saying the kidney transplants conducted by Mannami and his team were "experimental operations conducted in an unduly closed environment," and had "no medical validity under the current medical science practices."

The JST statement urged the Health, Labor and Welfare Ministry to revise the Organ Transplant Law later the same year to ban, in principle, the transplantation of disease-affected kidneys.

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Dearth of organs

The minute number of organ donors in this country was a major factor behind the transplants conducted by Mannami and his team.

As of the end of July, 11,538 prospective kidney recipients were registered with the Japan Organ Transplant Network (JOT)--a nonprofit transplant mediation body.

This figure compares with 1,201, or nearly one-tenth of the registered kidney-disease patients, who underwent kidney transplants in 2008.

A breakdown showed that 83 percent of these 1,201 individuals received kidneys from healthy living people, including relatives.

Fifteen percent of the kidneys were removed from people who died from heart failure, while only 2 percent of the kidneys were harvested from people declared brain-dead as stipulated under the Organ Transplant Law.

Kidney disease patients requiring artificial dialysis understandably are keen to receive kidney transplants, even if the organs come from people with kidney diseases.

In December, a group of kidney patients in Ehime Prefecture filed a lawsuit against leaders of the JST, claiming the statement it released in 2007 condemning Mannami's methods in effect infringed upon their right to receive medical treatment.

In response, the health ministry in January announced an "exception" to the ban on transplants involving disease-affected kidneys. The ministry said such transplants can be carried out when they are done for "clinical research" purposes.

Clinical research is generally considered as aiming to ascertain the effectiveness of newly developed treatment methods and verifying possible associated problems.

Although this practice differs from normal treatment, in patients' eyes, clinical research is no different from conventional medical treatment.

Tokushukai says it plans to entirely excise cancerous kidneys from patients whose renal tumors measure four centimeters across or smaller. After removing the tumors from the excised kidneys, Tokushukai will conduct transplants on 10 chronic kidney patients, the hospital group said.

Prior to these planned transplants, Tokushukai will conduct dual screenings: one by the group's own ethics committee and the other by an external panel of experts. Kidney transplant candidates will be selected from among those who have registered with the JOT, according to Tokushukai.

The transplants will be carried out by Uwajima Tokushukai Hospital and Tokyo Nishi Tokushukai Hospital in Akishima, western Tokyo.

Yoshihide Ogawa, a senior doctor of the urology department at Tokyo Nishi Tokushukai Hospital, said, "If our method of transplanting disease-affected kidneys becomes widespread, about 2,000 people with serious kidney trouble could be saved every year."

Tokushukai is set to accumulate clinical research data with a view to applying to the health ministry to have diseased-affected kidney transplant operations recognized as a legally valid medical treatment.

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Cancer-causing risks

However, Toho University Prof. Atsushi Aikawa, who serves as public relations committee chairman of the JST, notes, "The possibility can't be ruled out that Tokushukai's planned operations have a high risk of introducing cancer cells into the bodies of the transplant recipients."

The method of excising kidneys ahead of the Tokushukai-planned transplant operations differs from the normal treatment given to kidney patients.

When kidneys are extracted as part of cancer-related medical treatment, a kidney is removed after blocking the blood vessels surrounding it to prevent metastasis of the cancer.

Before kidney resection operations for transplants, however, blood vessels will not be blocked, in order to keep the kidney as fresh as possible.

The Japanese Urological Association has been advocating that operations for treating a kidney with a tumor measuring four centimeters in diameter or less should be conducted by resecting cancer-affected regions, instead of removing the entire kidney.

This is because the likelihood of cancer recurring in a partial resection or a complete removal of a kidney is essentially the same, though the partial resection retains the function of the kidney, according to the JUA.

Even if Tokushukai's insistence that no transplantee has ever developed cancer after receiving a disease-affected kidney is true, the removal of the entire kidney is almost certain to be inadvisable for the donor.

Will Tokushukai inform prospective donors and recipients of these medical facts and be able to obtain informed-consent agreements from both donors and recipients prior to transplantation?

For its part, Tokushukai has committed to making public its dual screening processes.

In the event of ambiguities appearing within the disclosed information, Tokushukai would likely again be subjected to a barrage of public criticism for attempting to lure prospective donors into having their kidneys improperly removed--a development that might destroy public trust in medical transplantation as a whole.
(Aug. 25, 2009)

http://www.yomiuri.co.jp/dy/national/20090825TDY04302.htm

[Stacy Without An E]

I just received a letter and consent form from UCSF to give my consent to accept a "risky kidney."  We're talking about kidneys from people with HIV or past drug or alcohol abusers.

So this is the solution to the kidney backlog...lower the standards?

Guess where that consent form was filed.