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Other nations, other answers: In search of a solution to the organ shortage

In the U.S., the push to study ways to increase organ donation is intensifying. Globally, other countries are testing various options.

By — Posted Oct. 13, 2008

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The U.S. transplantation system is approaching a tragic milestone. In late September, 99,728 people were on the United Network for Organ Sharing waiting list.

One waiting patient dies every 73 minutes. Three in four waiting patients need kidneys, with the average wait more than five years.

Yet transplant professionals in Iran -- which has the world's only legal, regulated system of kidney donor compensation -- claim to have nearly eliminated that country's waiting list. If their numbers were adjusted for the U.S. population, the kidney wait list would number 1,307.

Meanwhile, in Spain -- which, by law, presumes organ donation after death unless the individual said otherwise while alive -- the cadaveric organ procurement rate is 35% higher than ours. If the U.S. could do what Spain does with its presumed-consent law, the U.S. would net nearly 14,000 more organs a year.

In May 2005, a report from the U.S. Institute on Medicine's Committee on Increasing Rates of Organ Donation rejected policy options such as financial incentives and presumed consent. James F. Childress, PhD, chair of the IOM panel, told AMNews at the time that "certain underlying social and cultural conditions" would need to change to allow such policies to be widely acceptable. The risk of a public backlash against the transplant system, he said, would be too great.

Sally Satel, MD, does not agree. When the Washington, D.C., psychiatrist was diagnosed with end-stage renal disease in 2004, she briefly considered becoming a "transplant tourist" and later posted an ad on MatchingDonors.com. Ultimately, a professional acquaintance gave her a new kidney in March 2006.

But the sense of urgency she had as a patient carries on in her role as advocate and editor of a book, due this fall, that outlines the case for compensating U.S. kidney donors. "I'm for everything," Dr. Satel said. "Let a thousand organs bloom. Try incentives. Try presumed consent. Try improving donation after cardiac death. The question really is: How urgent is this problem?"

The American Medical Association is examining solutions to the organ shortage. In June, the AMA House of Delegates put the matter of studying ways to encourage organ donation high on the Association's legislative agenda. The AMA favors studying presumed consent as well as compensation for families of cadaveric organ donors. The Association will lobby Congress to change the 1984 National Organ Transplant Act, which bans "valuable consideration" in exchange for donation, to allow for ethically designed trials of financial incentives.

As the AMA presses for studies here, how have transplant policy experiments around the globe fared? Have they made an impact on organ donation? Can they be implemented ethically?

Iran's kidney "vendors"

Benjamin E. Hippen, MD, a transplant nephrologist in private practice in Charlotte, N.C., has written widely in favor of compensating living kidney donors. He knows firsthand the human toll of America's kidney crisis.

"I have 50 of my own patients that I see every week on dialysis, and I have to reconcile myself to the fact that there are some people I can help and some who I can't, in terms of extending their lives beyond what dialysis will provide them," Dr. Hippen said. "The organ shortage means not only that we have to essentially ration a scarce resource, but that while people are waiting for that resource they are getting sicker and accumulating more comorbidities. It's terribly frustrating."

In a monograph published in March by the Cato Institute, a Washington, D.C.-based libertarian think tank, he argued that "despite vast cultural and political differences between Iran and the United States, much can be learned from the Iranian system."

Iran implemented its unique kidney donor compensation system in 1988, and by 1999, the wait for kidneys was eliminated, according to a study in the Nov. 1, 2006, Clinical Journal of the American Society of Nephrology. By the end of 2005, nearly 20,000 kidney transplants had been performed in Iran, with more than three-quarters of the supplied kidneys coming from unrelated living donors who were paid.

The Iranian "vendors," as Dr. Hippen calls the compensated donors, get paid anywhere from $3,500 to $5,700. Between 70% and 85% of the vendors are poor and living on less than $5 a day, according to different studies. The payments are close to or exceed the annual per capita income.

According to Dr. Hippen's survey of available English-language medical literature, the difference in the 10-year survival rates for Iranians who received kidneys from vendors and those who got them from family members is statistically insignificant. The slightly worse outcomes for vendor kidney recipients could reflect some subclinical kidney disease linked to poverty, he said.

There are some major unknowns about the Iranian system. First is the question of what information from Iran can be trusted, given the authoritarian government. Second, there is no long-term follow-up on vendors.

Another unknown is whether the wait list actually has been eliminated. One Iranian transplant professional told the British Medical Journal last year that there are about 300 patients waiting for a kidney at any given time. Patients must wait six months to see if a cadaveric kidney becomes available before they are eligible to be matched with a vendor -- an attempt to encourage Iranians to donate other organs after death.

"It's hard to know all of the current reality of the Iranian model," said Francis L. Delmonico, a renal transplant surgeon at Massachusetts General Hospital and former UNOS president. "We don't know the number of patients that have kidney failure that don't make it to the list, who may not have the financial resources to get diagnosed."

The prevalence rate of end-stage renal disease in Iran is four times lower than it is in the U.S., although it is about double that of other Middle Eastern countries. But there is no standardized registry akin to the UNOS list.

Dr. Delmonico said an authorized, regulated trade in organs is still dubious because the poor are induced to take unnecessary medical risks.

"Just because it's legal, that doesn't solve the exploitation and the ethical problems. Eighty-five percent of the Iranians who sell their kidneys are male and poor. Is that what the testimony of the society is going to be? You sell your kidney to escape poverty?" he said.

"We just don't see rich people selling kidneys in the world."

Dr. Hippen and others who support U.S. organ markets say payment could be restricted to donors who earn more than the median income. Or, they argue, compensation could come in the form of contributions to retirement, health or college-savings plans, instead of cash.

Arthur J. Matas, MD, director of the renal transplant program at the University of Minnesota, supports financial incentives but shies away from looking to Iran as a model.

"It's hard to sort out what's going on," he said. "We're better off expressing the fact that we have a tremendous organ shortage, so let's do a clinical trial where we can get our own answers and see if we're capable in this country of increasing the number of organs while simultaneously protecting the donors -- and a trial will answer that."

Presumed success?

While only one Middle Eastern country has tested the impact of financial incentives, 22 nations, most in Western Europe, have presumed-consent laws in place, many for decades.

Instead of requiring individuals to sign up as donors while they are alive or having family decide whether to donate after death, the law assumes every dead person is an organ donor unless the government has been told otherwise. In practice, only Austrian transplant officials procure organs over a family's veto.

Advocates of bringing presumed consent to the U.S. have long pointed to the success of Spain, which boasts the best cadaveric organ procurement rate in the world.

But Kieran Healy, PhD, a Duke University sociologist and author of Last Best Gifts: Altruism and the Market for Human Blood and Organs, said the data show presumed consent does not set Spain apart. Rather it's the model of organ procurement -- a hospital-, regional- and national-level network of coordinators -- that accounts for the difference.

Healy said presumed-consent countries do slightly better than informed-consent countries, but their performance improved long after the laws went into effect and were due to systemic changes in the procurement process.

"The progress is at the level of managing the logistics effectively," Healy said. "That, to a large extent, is independent of the laws on presumed or informed consent."

Arthur L. Caplan, PhD, director of the University of Pennsylvania Center for Bioethics, said presumed consent is worth trying. However, he would pitch it as "donation by default" to ease Americans' concerns about states presuming to own people's body parts after death.

But, he argued, clinical care innovations are where to look to alleviate the organ crisis. "The flat-out truth is that markets, presumed consent, or renewed efforts at voluntary living donation are not going to solve the shortage," Caplan said. "The only hope to get enough organs is through some kind of stem cell or artificial organ work."

Dr. Matas, of the University of Minnesota, supports financial incentives and presumed consent, saying the current system is untenable. For him, the matter is elementary.

"What's better: maintaining the status quo and letting people die, or biting the bullet and making the changes and accepting that though these other things aren't perfect, they are better than letting people die?" he said. "It doesn't get any simpler."

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ADDITIONAL INFORMATION

The Iranian path to a new kidney

Iran's regulated, legal system of compensating living kidney donors aims to eliminate black market organ brokers and transplant tourists, encourage cadaveric organ donation, and give both rich and poor a chance to get a kidney. Once a potential kidney recipient -- who must be an Iranian citizen -- is identified, a screening process occurs.

Does the patient have a biological relative willing and able to donate?
Yes Donor evaluated and screened
Patient receives transplant
No Patient referred to Dialysis and Transplant Patients Assn., a volunteer patient-run organization that identifies potential paid donors, independent of transplant centers and physicians
Does the transplant center have active deceased-donor program?
Yes Patient waits six months
Is deceased-donor organ available?
Yes Patient receives transplant
No DATPA identifies potential paid donor, who must be an Iranian citizen age 20 to 35
DATPA refers donor to transplant center, which screens and evaluates using same standards as for unpaid donors
Iranian government pays $1,200 and offers one year of health coverage for donation-related health problems
Can recipient pay donor an additional $2,300 to $4,500?
Yes Recipient/family makes payment
Patient receives transplant
No Designated charitable organization makes payment
Patient receives transplant

Source: "Organ Sales and Moral Travails: Lessons from the Living Kidney Vendor Program in Iran, Policy Analysis No. 614," Cato Institute, March 20 (link)

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Black market for organs flourishing

Police in a suburb of New Delhi, India, in January busted an illegal organ racket -- run with the help of doctors, nurses and hospitals -- that reportedly had removed about 500 kidneys in the last 14 years from impoverished day laborers. Donors were paid as little as $1,000 for kidneys, which sold for nearly $40,000. This was only the most recent in a long string of similar cases reported in India, which banned kidney sales in 1994.

India is not alone as fertile territory in the global black market for organs. Extreme poverty, endemic corruption and a growing demand for transplants, especially of kidneys, have allowed trafficking to flourish in countries such as the Philippines, Pakistan and South Africa. This unregulated trade is universally condemned, as there is no assurance that donors are treated well or that recipients get healthy, matching organs.

There is disagreement on how to end the trade. Proponents of a regulated system of financial incentives argue that black markets are flourishing for the same reason bootleggers got rich during Prohibition -- there is no legal alternative. Market skeptics say payment for organs is inherently exploitive and cannot guarantee an end to the unregulated trade.

Last spring, 150 representatives from government, medical, scientific and ethical bodies from around the world gathered in Turkey for a meeting convened by The Transplantation Society and the International Society of Nephrology. This group issued the "Istanbul Declaration," stating that "organ trafficking and transplant tourism violate the principles of equity, justice and respect for human dignity and should be prohibited."

The declaration says policymakers should reimburse donors for costs directly related to donation but prohibit additional payment.

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External links

"Organ Sales and Moral Travails: Lessons from the Living Kidney Vendor Program in Iran," Cato Institute, March 20 (link)

"Iranian organ donation: Kidneys on demand," British Medical Journal, March 10, 2007 (link)

"A Gift of Life Deserves Compensation: How to Increase Living Kidney Donation with Realistic Incentives," Cato Institute, Nov. 7, 2007 (link)

"Do Presumed Consent Laws Raise Organ Procurement Rates?" DePaul Law Review, Winter 2005-06, in pdf (link)

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