Tuesday, March 1, 2011

Agencies consider new kidney transplant rules

Agencies consider new kidney transplant rules

Concept would match younger organs with younger patients, and vice versa


By Alex Johnson Reporter
msnbc.com msnbc.com
updated 3/1/2011 6:12:10 PM ET 2011-03-01T23:12:10

The rules that determine who goes to the top of the list for a kidney transplant could change dramatically under an idea working its way through federal health agencies.
Some transplant specialists and medical ethicists say the idea — which is under discussion  and hasn't been formally proposed to the Organ Procurement and Transplantation Network — is likely to be controversial if it is eventually adopted.
The complicated formula would give higher priority for access to the "best" kidneys to younger and healthier patients with a greater chance for long-term survival. That would be a significant shift from current first-come, first-served rules that, broadly speaking, favor patients who have been on the waiting list the longest, with less regard to age.
OPTN, a branch of the Department of Health and Human Services, is taking public comments through April 1 on a "concept document" outlining the idea, which was developed with the United Network for Organ Sharing, the nonprofit group that oversees U.S. transplant policy under a federal contract. The organizations said they wouldn't submit the revisions as a formal proposal unless they attract significant support.
Dr. John Friedewald of the Northwestern University School of Medicine, who is vice chairman of UNOS's Kidney Transplantation Committee, said the organizations had been working for more than six years to make sure the concept wouldn't reduce anyone's opportunity to receive a kidney, including an older or sicker patient.
"We still want to give that person a transplant, but we want to give the right kidney to the right person," he said.
Other specialists and transplant administrators, however, are raising questions about the idea and what they see as its potential to relegate older kidney patients to second-class status.
 
Lloyd Jordan Jr., chief executive of Carolina Donor Services, the federally designated transplant network for most of North Carolina and part of Virginia, said that while it is vital to reform the quarter-century-old kidney system to better "utilize the organs," any changes must be nondiscriminatory.
As a result, Jordan said, "I would be extremely shocked if a policy decision was made" by the target date of June 2012.
Closing the kidney generation gap More than 93,000 Americans are on the waiting list for the 13,000 or so donor kidneys that are available at any one time, according to OPTN figures through mid-February, the most recent date for which figures are available.
That disparity means many of them will die while awaiting organs, so "it's critically important" that kidneys are put to the best possible use, said Dr. Maryl R. Johnson, president of the American Society of Transplantation, a nonprofit research and professional group.
Johnson, a professor of medicine at the University of Wisconsin, said her group was "supportive of the concepts involved" but was waiting for more details before it takes a formal position. Among its potential concerns, she said, are the impact on "patients who have been on the waiting list a while" and the need for safeguards ensuring that they can be "brought into a new system in such a way that isn't negative to them."
Many factors go into deciding whether a patient can get a kidney and when: physical match (you must be able to tolerate the kidney without rejecting it), where you live (transplant networks are divided into regions of the country) and how long you've been waiting. The procedure can cost more than $100,000, specialists said.
The concept document says today's system is inefficient because it allows "the allocation of organs with very long potential function to candidates with very short expected survival after transplantation, and vice versa."
In plain English, Friedewald said, that means a patient in his or her 60s can get a kidney from a donor decades younger — a kidney that could have functioned well for many more years after the patient has died of some other cause. And patients in their 20s can get kidneys from much older donors that would wear out naturally in a few years and have to be replaced anyway.
What the transplant agencies are looking at is a system that would optimize "the lifespan benefit per transplanted organ" by trying to match younger kidneys to younger patients and older kidneys to older patients. It would do that by reserving the 20 percent of donated kidneys that are considered the healthiest (which roughly correlates with those from the youngest donors) for the patients with the best chances of living long, healthy lives.
The transplant network would try to match the remaining kidneys with patients who are within 15 years of age either way of the donor. (Living donors, who the National Kidney Foundation says make up 44 percent of the donor pool, wouldn't have to factor that into their decisions, because the revisions would apply only to kidneys from recently deceased donors.)
"While the current design of giving most of the priority based on waiting time may be perceived as 'fair,' it does not strive to minimize death on the waiting list nor promote maximized survival following transplant," the concept document says. "The system can be better and it can be designed to achieve more in the way of health and longevity than it currently does."
Deadline may be hard to keep Other experts agreed with Jordan, of the North Carolina network, that it may be difficult to persuade the public that the revisions wouldn't discriminate against older patients, said Dr. James McCabe, a kidney specialist in Wilmington, N.C.
 
Some will interpret the document as a declaration that "we cannot give you this organ because of your age," McCabe said. "I think that will put a lot of people up in arms."
But Friedewald said that the concept could make kidneys more available to older patients, because organs from older donors would be less likely to given to given to younger patients.
"We know the candidate population is aging, but the donor population is aging, too," and those donated kidneys would be put to better use in older patients, he said.
In some respects, what the revisions would do is bring kidney transplants more in line with transplantation of other organs, like the heart and the lungs, in which doctors look for as close to a perfect match as possible.
Kidneys are allocated differently because "tissue matching is not as important as it used to be," thanks to improvements in immune system-suppression drugs that lower the chance of rejection, Friedewald said.
Doctors can also extend a kidney patient's life through dialysis, while specialists in other organs don't have a similar option, he said.
Dialysis, however, is extremely unpleasant, said Kevin Moore, a radiation technician at DaVita Dialysis Center in Wilmington. Moore received a transplanted kidney himself a few years ago at age 33 after nine years on the treatment, in which the blood was removed from his body, filtered by a machine and put back in.

"Whenever I walk through that treatment floor ... I have flashes of when I was there," he said.
That is why — even though he might have gotten his kidney more quickly under the revisions being considered — he believes "whether you're old or young, give everybody a chance."
Johnson, of the American Society of Transplantation, wouldn't predict how the discussions might play out, but she agreed that the process could be complicated while the transplant agencies work "to get out to the public what this actually is" and "why it's important to people."
"I understand the way they go through these ideas," she said. "They're trying to take this in small steps."

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