Organ allocation regs reignite controversy
Guidelines aren’t enforced, critics argue
The nation’s organ transplant system yet again is at the center of controversy. Critics are charging that the Clinton administration isn’t enforcing its new guidelines involving organ allocation while others are concerned about proposed strategies to increase the amount of available organs at the expense of donors.
A flurry of activity last month on both sides of the organ transplant debate has no doubt left transplant center surgeons, patients, and ethicists in a state of confusion over current policies, proposed legislation, and new scientific data. (For more on the scientific data, see related story, p. 105.)
Charges came from contractor
Much of the activity involved policy changes announced at the Richmond, VA-based United Network for Organ Sharing (UNOS), the contractor responsible for maintaining the U.S. organ transplant waiting list.
UNOS has contracted with the Health Resources and Services Administration of the U.S. Department of Health and Human Services (HHS) for 15 years. HHS has announced, however, that it is looking at bids from other organizations to run the nation’s organ transplant system.
Earlier in the summer, UNOS announced a policy change giving pediatric patients (under age 18) preference over adult patients in similar medical need. The change applies to existing distribution areas and the liver donor must also be under age 18.
Chances for survival will increase
Data analyzed by UNOS committees showed that the policy will reduce waiting times and increase survival among pediatric liver patients without affecting the mortality or waiting time of adults awaiting liver transplants, notes William Payne, MD, outgoing UNOS president.
"We’re very proud of the extensive analysis of data and open debate which ultimately results in important lifesaving policies and guidelines for those most involved in the transplant process," adds Payne.
Another policy change most recently announced by UNOS is currently under a public comment period. The organization would implement a scale to determine the medical urgency of patients waiting for a liver transplant and identify those at risk of dying quickly without a transplant. Under the proposed change, patients identified at greatest risk of dying in the short term would be given a higher priority.
The proposal was distributed formally during mid-August, and written comments must be submitted to UNOS. A public forum will be held this month to discuss the proposal. The UNOS Liver and Intestinal Organ Transplantation Committee will then issue a final proposal in November.
Change is overdue, critics argue
Critics say that UNOS’ efforts at establishing a scale to determine medical urgency wouldn’t be necessary if it would follow current federal regulations. The National Transplant Action Committee, a Portland, OR-based national nonprofit organization founded in 1995, charges that UNOS missed two key deadlines since the new regulations went into effect March 16.
But transplant surgeons involved in the UNOS policy development say the criticism is unwarranted. "This is an essential first step in refining national liver transplant policy," says Todd Howard, MD, chair of the UNOS Liver and Intestinal Organ Transplantation Committee. "This sets the stage for consideration of the optimal area we should use in distributing livers to meet patients’ needs," he adds.
In fact, an analysis of the most recent changes indicates that urgent patients receive a large — and increasing — proportion of donated livers. As a group, patients who risk imminent death within days without a transplant received 34% of transplants between Aug. 1, 1999, and May 31, 2000. Those patients are classified as Status 1 and 2A patients under UNOS criteria. The change is a roughly 50% increase over patients similarly classified as Status 1 in 1997 — the equivalent ranking prior to the new classification.
Currently, Status 1 and 2A patients combined comprise only one-half of 1% of the national waiting list for transplants. The changes show that UNOS is meeting the needs of the sickest patients, says Patricia Adams, MD, president of UNOS. "However, we must carefully balance medical need with the obligation to make the best use of donated organs," she adds.
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