The fairness of the nation's organ transplantation system would be "significantly enhanced" if donated livers were shared over wider geographic regions, according to an independent, congressionally commissioned report released yesterday.
The much anticipated study by the Institute of Medicine--part of the National Academy of Sciences--lends key support to a controversial federal proposal to revamp the national system by which donated livers are allocated to desperately ill people.
But it appeared unlikely that the report would settle the two-year-old, high-stakes dispute over how to implement those changes. Proposed by Health and Human Services Secretary Donna E. Shalala, the plan has been vigorously opposed by the United Network for Organ Sharing (UNOS), the federally chartered consortium of transplant centers and patient representatives that oversees the collection and matching of organs for transplantation.
Rather, by concluding that the system of organ allocation is basically sound but also in need of change, the 210-page report gave both parties a way to claim victory.
"I guarantee, all you're going to get is a bunch of people trying to explain this thing with their own spin," said John Fung, a liver transplant surgeon at the University of Pittsburgh Medical Center. "The report is now public. But the political action on this is going to be done behind the scenes."
At issue is how the nation should distribute organs to patients who need them. More than 60,000 people are awaiting organs on any given day in the United States; every year, about 4,000 die waiting.
In general, organs are made available first within a local area, then over regional and national ranges if no appropriate local recipients can be found. That has led to a situation in which comparatively healthy patients sometimes get organs while sicker ones die waiting.
Last year, Shalala released a "final rule" that called upon UNOS to come up with a system that would alleviate this disparity. Although the rule did not spell out how UNOS should accomplish the goal, wider sharing of organs seemed inevitable.
Shalala's rule applied to organ transplants generally, but it demanded that changes be made most immediately for livers, because those organs survive long-distance travel better than most.
UNOS balked, claiming in part that smaller transplant centers would be driven out of business by larger centers, and also expressing fears that people would be less likely to donate organs if they knew the organs might be shipped elsewhere.
Last year, Congress held up implementation of the new rule and asked the Institute of Medicine to look into the issue. Financial and political elements proved as complicated as the medical issues.
With individual transplant costs ranging as high as hundreds of thousands of dollars, enormous sums are at stake. Also at issue is whether the federal government should tell doctors how to make patient care decisions.
The Institute of Medicine report is largely supportive of Shalala's pending regulations. Based largely on an analysis of 68,000 liver patient records, it concludes that severely ill patients would best be served if liver-sharing regions included at least 9 million people.
"The net result will be that more transplants will occur for the most medically ill patients," said committee chairman Edward Penhoet of the University of California at Berkeley.
As the report was going into final review in June, UNOS adjusted its policy to allow such widespread sharing of livers for the most critically ill, or "status 1" patients. But committee members said yesterday that the policy should apply to all patients.
The report also supports Shalala's insistence that her office has the power to set policy guidelines for UNOS. And it calls for better data gathering and distribution by UNOS, so that doctors, patients and others can more easily figure out how to make the best use of resources.
The report finds no evidence that smaller transplant centers would go out of business with wider sharing. That's important to patient advocates, who worry that a consolidation of the transplant business might force patients to travel long distances for their operations, and lose the close support of family, friends and personal physicians.
"It's really important to a patient to have relatively close access to a transplant center," said Margo Akerman, vice president for patient and donor family affairs at UNOS, which is based in Richmond.
The report also finds no evidence that people will be less likely to donate organs under a system of more widespread sharing.
In support of UNOS's past claims, however, the report concludes that some of the apparent disparities in the current organ allocation system, including widely reported gross differences in how long people have to wait for organs in different parts of the country, have been exaggerated.
Shalala recently said she was making some changes in her final rule, which is due to take effect in October. But UNOS yesterday called for complete revision.
"We feel strongly that since the system has now been shown to be basically fair, HHS should withdraw the regulation as written and rethink it and rewrite it," Akerman said.
Both sides stressed the need to increase donations. "This report is not the ultimate solution," said committee member Mitchell W. Spellman of Harvard Medical School. "The ultimate solution is more organ donations."
Penhoet expressed the hope that the report would promote that goal by showing people that the system is basically good and getting better.
"One of the most important factors in encouraging organ donation," he said, "is people's belief that the system is fair and equitable."
Liver Transplant Facts
Patients awaiting transplant, July 14: 13,388
Yearly transplants, 1998: 4,450
Number of transplant programs: 125
Longest time a transplant functioned: 27 years, 11 months
SOURCE: United Network for Organ Sharing