PITTSBURGH, June 25, 1997 — A transplant surgeon from the University of Pittsburgh Medical Center (UPMC) who has long been critical of the liver allocation system operated under federal contract by the United Network for Organ Sharing (UNOS) today called for the UNOS board to rescind its previous decision that gives preference to patients on the transplant waiting list with acute liver disease over those urgently ill patients with chronic conditions.
"I strongly urge the members of the UNOS Board of Directors to reconsider the decision made in November, 1996, and to rescind the change in definition of a status 1 liver candidate made at that meeting," wrote John J. Fung, M.D., Ph.D., associate professor of surgery and chief of transplantation at the UPMC, in a letter he distributed today at the start of a two-day board meeting in Arlington, Va.
Dr. Fung claims data published in UNOS's 1996 Annual Report contradicts any justification for its decision made at the November board meeting that redefined status 1 -- the most urgent classification used in the allocation system -- to include only patients with sudden, acute conditions. He also believes a scientific analysis, which has not been performed, is warranted before any change in policy is implemented.
The November policy change drew widespread criticism from patients and patient advocacy groups. It was implemented for a brief time in January, then deferred by the board in March, and is expected to be totally operational July 4. At this time, all patients with chronic conditions who experience life-threatening complications will be relegated to a less urgent status. Although surgeons may advocate a change in a particular patient's status through new regional review boards, acute patients will still be deemed the highest priority.
"From the very beginning, those individuals and programs which have advocated and supported the change in status definition have based the change on patient and graft survival rates post-transplant...," Dr. Fung says in the letter addressed to new UNOS President Lawrence G. Hunsicker, M.D. He continues by stating "the premise on which UNOS based such change is invalid."
Disputing the notion that acute patients fare better after transplantation than chronic patients, Dr. Fung cited published data that show no statistically relevant difference between the two groups. In one comparison, one-year patient survival rates for status 1 patients (the old definition consisting of acute and chronic patients) is 69.9 percent, and in patients with fulminant hepatic failure, an acute condition, one-year survival is 70.8 percent.
Dr. Fung also pointed to computer modeling results that predict more deaths will occur in urgently ill chronic liver disease patients on the waiting list if any changes to prevent them from achieving the highest priority go into effect. He has publicly argued this point, saying the change will exacerbate the inequities of an already unfair system that does not serve patients' needs.
Among Dr. Fung's and the UPMC's chief concerns are:
Artificial geographic boundaries often prevent donated livers from going to the sickest patients.
Disparate waiting times from center to center and state to state result in an unnecessarily large number of patients dying on the waiting list.
The UNOS policy decision process places concerns of transplant programs and organ procurement organizations over those of patients.
Recognizing the need for reform in the system, the U.S. Department of Health and Human Services held public hearings December 10 to 12 last year. Based on written comments and oral testimony, including that of Dr. Fung and numerous patients, U.S. Secretary of Health Donna Shalala is expected to issue final liver allocation regulations. Under the National Organ Transplant Act, the Secretary has the authority to oversee the government contractor, UNOS.