LOS ANGELES (Nov. 16, 1999) - A long-running controversy over the nation's method of determining which potential recipients will receive donated livers is about to be put to rest -- or ratcheted up another notch -- with the Department of Health and Human Services apparently poised to enact its final ruling in January.
HHS oversees the United Network for Organ Sharing (UNOS), the private, not-for-profit organization that administers the national Organ Procurement and Transplantation Network. UNOS members include every transplant program, organ procurement organization and tissue typing laboratory in the United States.
Under the existing liver procurement system, the United States is divided into 11 regions, with 63 local organ procurement organizations (OPOs) within those regions. When a donor liver becomes available, UNOS policies have traditionally sought to find a local recipient first before offering the organ regionally and finally nationally.
But early last year, HHS Secretary Donna Shalala ordered UNOS to devise a new distribution system that would give priority to the sickest patients, regardless of geographic location.
Among its intended benefits, the directive aimed to reduce the disparity that exists in transplant waiting times from one location to another. One candidate might be transplanted in fewer than 60 days, for instance, while another, only a mile away but in a different UNOS region, could be on a waiting list for more than 500 days.
But instead of fixing the problem or specifying how the new system might work, Shalala's order, which was supposed to have been implemented within five months, created an outcry within the transplant community. In response, UNOS intensified its study of options and their potential impacts, and Congress eventually placed a moratorium on the HHS regulations and asked the Institute of Medicine to investigate the dispute.
An arm of the National Academy of Sciences, the Institute assembled a panel of 16 experts and began its study earlier this year. Meanwhile, several states have started developing legislation that would contest federal mandates and keep donor organs within their own jurisdictions until every option has been exhausted. But for now, awaiting final resolution, the transplant community has continued to follow the existing UNOS guidelines.
The Institute of Medicine issued its report in late July and backers of both UNOS and HHS found sufficient evidence within the 210-page document to claim victory. So while UNOS supporters suggest the regulations need to be reworked, HHS appears likely to move forward.
"There have always been questions about the fairness of the allocation strategy, particularly as it pertains to liver transplantation," says Christopher Shackleton, M.D., an organ transplant specialist at Cedars-Sinai Medical Center who served several years ago on the UNOS Liver and Intestinal Transplant Committee.
Transplant policymakers constantly try to achieve a balance between justice -- defined as fair and equal access to the national resource of donor organs -- and medical utility -- the urgency of a patient's situation and need, says Dr. Shackleton. "With the disparity of supply and demand, we're constantly grappling with the issue of how to balance medical utility with justice. Who gets these organs?"
Although other organs also are subject to allocation issues, livers tend to be in the spotlight because demand is especially high and donations cannot keep pace.
"We wouldn't have this controversy if there weren't such a problem in the mismatch between donor organ availability and the number of people who need transplantation," according to Dr. Shackleton. "For liver transplantation, the list continues to grow at 30 percent per year. Cadaveric organ donors increase at two percent per year. Those two are never going to match."
Transplant surgeons have developed new techniques to try to expand the donor pool -- "splitting" a single cadaver liver to implant one adult and one pediatric recipient, for instance, and transplanting part of a liver from a living donor. Still, with nearly 14,000 patients currently on the national liver waiting list, determining who receives those organs that do become available will continue to be hotly debated.
During the time he was a member of the Liver and Intestinal Transplant Committee, UNOS hired a statistical and computer modeling firm to assess more than 90 organ distribution strategies. Of those, only two made a meaningful difference in "hard outcome" compared to the current system, Dr. Shackleton says, but even with those two, questions of fairness, justice and waiting time persisted.
In one theoretical scenario, only patients who had chronic liver disease but were not terribly sick received a transplant. Because of their relatively good health, they were at lower risk and were able to tolerate the rigors of the major operation. In this case, overall survival rates would likely increase by about six to eight percent.
In the other computer-generated scenario, only the sickest patients -- those who would likely die within seven days without a transplant -- received a liver. Based on the results of the study, "when you allocate livers as first priority on a national level to those types of patients, your overall outcome drops by about six or eight percent because these patients are sicker and their survival is poorer," says Dr. Shackleton. "This does not take into account a second major consideration, not included in the model, which is the prolonged time the organ is out of the body and in preservation solution."
Logistics presented another problem. "One of the displays of the computer program showed the cumulative mileage traveled by the donor organs. With most of the models, after six days into it, there were 5,000 to 8,000 miles traveled. With the national strategy, prioritizing for the sickest patients on a national level, within six days we reached 60,000 miles," Dr. Shackleton says.
Many factors contribute to the complexity of designing a fair and effective organ transplantation policy. For example, local transplant centers vary in expertise and experience with different organs. Some states, regions and even cities offer several transplant programs while other areas have few.
"It may be fair to allocate organs on a national level to the sickest patients but when you are managing a national resource, trying to do the most good for the greatest number of people, there are legitimate questions to ask," says Dr. Shackleton. "We know that if we transplant the sickest people, the outcomes are poorer than if we transplant those who are less ill at the time of transplant. When we look at the number of years of life gained, cumulatively, through this use of the organ resource, is that the most appropriate use? I'm not saying yes or no but it's a valid question to ask. Which way have we best served society in the utilization of the resource? I don't know the answer and I don't think anybody does, but there has to be a balance."
Dr. Shackleton recently returned to Cedars-Sinai Medical Center where he once served as program director for the Center for Liver Diseases and Transplantation. He will assist in a major expansion of the hospital's transplantation services.
A native Canadian renowned for his high rates of success in organ transplantation, Dr. Shackleton was involved in the establishment of transplantation programs and policies in Canada in the early 1990s. In 1993, he came to Southern California to breathe new life into the whole organ pancreas transplant program at the University of California Los Angeles. He also played a major role in UCLA's pediatric liver transplant program, introducing microsurgical techniques of arterial reconstruction that resulted in better function and improved success rates.
He is available to provide additional perspective on current policies and issues in transplantation
For media information and to arrange an interview, please e-mail sandy@vancommunications.com or call 1-800-396-1002. Thanks for not including media contact information in stories.