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​Liver Transplant Candidates Jeopardized Through New UNOS Policy

PITTSBURGH, January 15, 1997 — Come Monday, Jan. 20, the chances that a patient with a life-threatening complication of chronic liver disease will get a liver transplant will be reduced, even if a suitable organ becomes available. This is because a United Network for Organ Sharing (UNOS) policy goes into effect that will overlook this patient's medical urgency and allow him or her to be bypassed by a patient with sudden acute liver failure or by a less-sick chronic liver disease patient in the hospital who has been waiting longer. Widespread protest from patient advocacy groups and individual patients, who believe both their disease and the liver allocation policy to be a double death sentence, have not been enough to stall or prevent implementation by UNOS.

Critics from the University of Pittsburgh Medical Center (UPMC) say the policy decision made by UNOS at its Nov. 13-14, 1996, board meeting and its disregard for the concerns and needs of patients expressed since then, exemplify UNOS policy making practices that place transplant centers' self-interests before those of patients. Calling for the need for greater government oversight of UNOS, the UPMC also charges the decision sidesteps the core issue regarding liver allocation -- that UNOS-imposed artificial geographic boundaries have created an unfair system that prevents organs from going to the sickest patients and results in extremely disparate waiting times from state to state.

"The new policy will advantage a few and disadvantage many. And, it will only compound an already unfair liver allocation system , resulting in even more patients unnecessarily dying on the waiting list," says John J. Fung, M.D., Ph.D., associate professor of surgery and chief of transplantation at UPMC.

UNOS holds the federal contract to operate the organ procurement and transplantation network, which was set up through the National Organ Transplant Act of 1984 under authority of the Secretary of the U.S. Department of Health and Human Services (HHS). In HHS public hearings on liver allocation held in Bethesda, Md., Dec. 10 -12, 1996, testimony was given by more than 105 people, many of whom were patients concerned about UNOS practice and the new policy that will affect those with chronic liver disease. The hearings, which were announced just five days prior to the UNOS board decision, were intended to provide Secretary of Health Donna Shalala information on which to base a decision about which liver allocation system is best for the patients of America. Her decision is expected within the next couple of months.

According to Dr. Fung, the board based its decision on what he considers dubious data indicating acute liver disease patients fair slightly better after transplantation than do chronic liver disease patients in the intensive care unit (ICU).

In a conciliatory move, UNOS announced at the HHS hearings that chronic liver disease patients who are in the hospital the day the policy goes into effect will be offered a reprieve for as long as they remain in the hospital. These patients classified as either status 2 (hospitalized on a ward) or status 1( hospitalized in an ICU with a life-threatening complication) will still be given priority for organs under the old system through a "safety net" created by UNOS.

"But what about all other patients? Chronic liver disease patients comprise 99 percent of those on the transplant waiting list. What happens to these patients when they suffer serious setbacks?" questions Dr. Fung.

UNOS also has recently announced it is considering creating an intermediate status for these patients, an admission on its part that the policy change should not have been made in the first place, says Dr. Fung.

Dr. Fung expects the new policy will result in:

  • No improvement in inequitable waiting times from state to state;

  • An additional 200 patients dying on the waiting list each year;

  • No significant increase in the number of transplants performed each year; and

  • A continuing practice of electively transplanting less-sick patients while sicker patients exist elsewhere.

"Organs should be shared freely within the largest geographic area as is medically feasible and allocated to the sickest patients -- who have the most to gain -- no matter their disease, how long they have had it or where they choose to receive their transplant," argues Dr. Fung.

More than 7,000 patients are on the UNOS liver transplant waiting list. The majority of these patients have a chronic liver disease such as hepatitis, alcoholic cirrhosis, primary biliary cirrhosis, sclerosing cholangitis, autoimmune liver diseases, cancer and other inherited diseases of the liver. Such patients are at constant risk for developing a sudden, major complication of their disease that requires hospitalization in an intensive care unit. At any given time, these patients comprise 90 percent of the transplant candidates in ICU beds.


Under the new policy, chronic liver disease patients, despite having only days to live, will be considered in a less urgent class than patients with sudden liver failure with the same life-expectancy. The only patients eligible to be status 1, the most urgent classification, are those not expected to live beyond seven days and who have one of four medical conditions involving acute liver failure. These are: fulminant hepatic failure (sudden and severe), decompensated Wilson's disease, primary nonfunction of a transplanted liver within seven days of implantation, and hepatic artery thrombosis involving a liver implanted in the last seven days. All other hospitalized patients will be listed as status 2, regardless of whether they are in an ICU or not, the medical urgency of their condition or their life expectancy. For status 2 patients, time on the waiting list will carry more weight than their medical conditions. Children will not be affected by the new policy and will be able to be listed as status 1. But children will continue to be penalized by the overall UNOS liver allocation policy that prevents organs from being shared on a national basis.

Organs will still be allocated on a local, regional, national basis. When an organ becomes available in a local area, it is offered to patients on local transplant center waiting lists in descending order, first to status 1, then to status 2 and then to status 3 patients, those who require constant medical care but are able to function at home or work. (Status 4 was eliminated as part of the new policy. Any status 4 patients currently on the list will become a status 3.) If it is not used in one of the 69 local areas, the liver is then offered in the same manner within the larger region, of which there are 11, that encompasses the local area. Only if it is not used in the larger region is the liver offered on a national basis.


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