MILWAUKEE, April 8, 1998 — A transplant surgeon from the University of Pittsburgh Medical Center (UPMC) told a congressional subcommittee convened here today he supports a regulation recently announced by the U.S. Department of Health and Human Services (HHS) that will provide oversight of the transplant system and protect the welfare of patients awaiting transplants. Testifying at a hearing of the Human Resources Subcommittee of the House Committee on Government Reform and Oversight, John J. Fung, M.D., Ph.D., urged that its members not be swayed by the politically motivated arguments presented by the United Network for Organ Sharing (UNOS), which opposes any oversight, but to base their conclusions on the facts, which clearly justify the need for government intervention.
UNOS is a private corporation that holds the federal contract to operate the Organ Procurement and Transplantation Network (OPTN), which was created by the National Organ Transplant Act (NOTA) of 1984. NOTA called for a fair and equitable national organ allocation system with oversight by the Secretary of Health and Human Services. For more than 10 years, HHS has not exercised oversight with the issuance of final rules. As a result, UNOS and its transplant center members have been allowed to make self-serving policy decisions that directly affect patients’ lives. Several government reports have highlighted the inequities such a system has created.
"Secretary [Donna] Shalala should not be faulted with the lack of progress by her predecessors in issuing the final regulation. She should be complimented for getting the final rule right for patients at long last," testified Dr. Fung, associate professor of surgery and chief of the division of transplantation surgery at the University of Pittsburgh’s Thomas E. Starzl Transplantation Institute .
The final rule reaffirms the government’s role as a public advocate and defines principles and performance goals that provide a broad framework for the operations of the OPTN. It mandates: that new policies be developed in order to have in place an organ allocation system that promotes broader sharing of organs to patients in the most urgent need, regardless of where they live or are listed; that criteria for listing and status definitions be standardized; and that up-to-date information about transplant centers be more accessible to patients. UNOS has 150 days to devise liver allocation policy that meets these goals and one year to devise policies affecting other organs.
"Given the time allotted by the Secretary to devise polices to achieve these goals, one would expect UNOS to begin committee deliberations. Instead, we have seen a flurry of media and lobbying activity to attempt to influence legislators to intervene on behalf of UNOS and transplant programs."
UNOS has employed "scare tactics" to mislead the public and patients into thinking the regulations will do harm, Dr. Fung asserted.
"It should be emphasized that this regulation in no way affects the freedom of patients to select a transplant center; it does not force patients to travel any farther to a transplant center than they wish to; it does not call for the closing of any transplant centers." There is no evidence to support these claims or other claims, including that organ donations would suffer with the new rule or that the rule would encourage transplants in futile patients, Dr. Fung told the subcommittee.
Furthermore, the regulation "does not encroach on either the OPTN’s authority to establish membership and medical criteria as set forth in NOTA or the OPTN’s policy-making function. To the contrary, HHS is offering UNOS wide latitude to restructure its system of allocating organs, demanding only that the final product achieves the principles set forth in the HHS regulation," testified Dr. Fung.
The UPMC has long argued that the transplant system is not fair to patients. As an example, the liver allocation policy -- which emphasizes preferential use of donated organs within the local areas where organs originate even when there may be a sicker patient elsewhere -- has resulted in great disparities in the amount of time patients wait for transplantation. Some patients in some areas wait as much as five times longer than patients elsewhere. In addition, such a system creates disparities in the odds that patients will die on the list. For example, 17 percent of the patients in the most urgent status will die on the waiting list in one region, while 50 percent in another region may be expected to die.
According to computer modeling performed by both UNOS and CONSAD Research Corporation and referenced in the preamble to the HHS regulation, broader sharing of livers would equalize waiting times across the country, reduce the number of deaths (on the waiting list and after transplantation) and save more lives.