Organ procurement group changes liver policy
The United Network for Organ Sharing (UNOS), the Richmond, VA-based nonprofit organization that administers the national Organ Procurement and Transplantation Network, voted in June to change the way donor livers are made available for transplant nationwide.
Under the new policy, livers must be made available to all Status 1 patients — those in the most urgent category of need — in the wider "regional" area before being offered to less-urgent candidates in the "local" area in which the donor organ originated. The country is divided into 11 regions serving 125 liver transplant centers.
Previously, available livers were offered to all medically eligible local recipients first, then to recipients on lists in the same region, then to recipients nationally. (For a detailed breakdown, see chart, p. 107.)
"The problem is, donor livers become available on sort of a random basis. In one area, you might have to wait a week or two for a liver that is the right blood type, etc. Whereas, next door, they may have several," explains Jeremiah G. Turcotte, MD, director of the Ann Arbor-based University of Michigan Medical Center’s liver transplant program and immediate past chairman of the UNOS liver and intestinal organ transplantation committee, which developed the new allocation policy.
"By having a larger population base to donate the liver, you take the randomness out of it. However, there will still always be fewer livers available than are needed."
The committee originally made regionwide sharing a voluntary process; it is now mandatory. "The regions that did not participate in the voluntary program will need to come up with a proposal of how they are going to share regionwide," Turcotte adds.
"There is some variation in what the impact will be for different regions. It is much different to be in an area where you have a half-dozen similar-size hospitals with transplant programs. It is a lot different than being in a smaller program right next to a large transplant center. The policy will allow people to share but also to pose some variance that will make it feasible in their area. That variance will have to be approved by the liver testing committee."
The new policy’s adoption comes in the wake of a report from the federal Institute of Medicine (IOM) evaluating the fairness of U.S. organ transplant policy. (See related, story, p. 108.) Addressing longstanding criticism that the system administered by UNOS favored established transplant centers instead of benefiting the largest number of critically ill patients, the U.S. Department of Health and Human Services (HHS) proposed regulations in 1998 that would have established a nationwide system of organ-sharing. (See Medical Ethics Advisor, April 1998, p. 37, and May 1998, p. 49.)
Many in the transplant community opposed the new regulations, and HHS instituted a moratorium on enforcement while the matter was studied by IOM.
The new UNOS policy is a step forward, but it still does not remedy inequities in the liver allocation system, says Goran B. Klintmalm, MD, PhD, FACS, director of the Dallas Liver Transplant Program and director of the Baylor Institute for Transplant Sciences at Baylor University Medical Center in Dallas.
"It is an improvement, but a miniscule one," says Klintmalm, who has been critical of UNOS policy and testified before the IOM committee on organ procurement and transplantation policy, which was evaluating the system.
"It will affect only in the neighborhood of 25% of the patients. I do 50% of all liver [transplants] in this region, and we do only six of those Status 1s a year. The acute patients are taken care of, but it is those who are sick, but not as urgent, they are the ones who suffer. That is the problem, and that is why we need a patient-centered system."
Turcotte acknowledges that changes still need to be made in the way patients are categorized and ranked for consideration for transplant. The committee now is looking at a new model: one that would rely less on the concepts of geography, waiting time, and current status as the main factors in determining a recipient’s placement for transplant.
"What we are looking at, which I think is a more ethical approach to the whole subject, is the probability of dying while on the waiting list," says Turcotte. "If you are a patient, that is your main concern."
Making it fairer for patients
The committee is examining data and trying to arrange an allocation system that would allow all patients to have the same probability of dying on the waiting list, regardless of their initial status.
"The way liver disease works, you could be doing reasonably well enough in the hospital, and some event happens, and you die," he says. "The statuses we have are useful but they don’t really predict how long you are going to live; they predict how urgent you are at the moment."
The committee still needs more data to establish a new policy, but Turcotte says it will be a more ethical policy once they can allow patients who are less urgent a chance to receive a liver transplant.
"As it is now, I think many places almost never do a Status 2b because they use up all of the livers," he says. "We should have our resources spread out a little bit, so that some people at Status 3 should be able to get a liver because they have been waiting a long time and so on. The big ethical question is, is it really fair to use up all of the livers on the people who are very sick at the top of the list and the only way you ever get a liver is to get really sick?"
Regulation and enforcement a problem
Klintmalm and Turcotte agree that a much-needed overall change in transplant policy is a reliable system of enforcement of allocation regulations.
"The whole system depends on trust between the various people in the system and enforcement of those regulations," says Turcotte. "The HHS has not been willing to enforce anything, which makes it difficult to impose regulations. If people are not confident that everybody is abiding by these regulations, they do not want to abide by them. We are going to have to have some sort of self-regulations or oversight by the government."
Klintmalm argues that a new regulatory body, one independent of both the government and the medical transplant centers and staff, is needed to enforce a fair system.
"Right now, UNOS oversees itself and issues regulations," he says. "One thing that the IOM report states is that there should be an independent advisory board, independent of the HHS as well as UNOS, and I think that is one of the most important points, but it has been largely overlooked."
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