Saying that who receives an organ transplant should be a matter of medical need, not "accidents of geography," Health and Human Services Secretary Donna Shalala published regulations Thursday changing how organs are distributed.
While Shalala says the new regulation will save lives, the head of Utah's only liver transplant program says it will be disastrous for some patients.The United Network for Organ Sharing has run the national transplant network since 1986 and available organs were rationed based on geographic area and then medical need. Patients who were less ill could receive a transplant before someone with more urgent need outside the geographic area.
"Patients who need an organ transplant should not have to gamble that an organ will become available in their local areas, nor should they have to travel to transplant centers far from home simply to improve their chances of getting an organ," Shalala said. "Instead, patients everywhere in the country should have an equal chance to receive an organ, based on their medical condition and the judgment of their physicians."
In 1996, 20,000 Americans received organ transplants. But this month more than 55,000 were on waiting lists for organs, with about 500 added each month. About 4,000 people a year die waiting for a transplant.
"As a result of the new proposal, a donor liver in our area is more likely to be sent out to other areas. It may benefit a few in our area who suddenly become ill and have an urgent need for a transplant," said Dr. John B. Sorensen, medical director of the liver transplant program at LDS Hospital.
"On the surface, it sounds like a way to address the acute need of people who are dying in the hospital because of a need for transplants. If you look at the big picture, people are going to have to progress to a point where they require hospitalization. They will wait a lot longer and get sicker and sicker."
Research says the most successful transplants are those to people who are still relatively healthy, he said. With the sickest patients, the organ transplant is more likely to fail and "you have taken an organ that could have helped someone and wasted it," he said. The sickest patients "tend to require more than one organ transplant to get through the whole experience."
Heart transplants are unlikely to be as impacted by the regulation, because they cannot be transported as far and cannot be outside someone's body as long. They're still apt to be distributed somewhat geographically. And most people who are waiting for kidneys are on life-saving dialysis.
But the real issue, according to Sorensen and others, is the scarcity of organs available for transplant.
"The big point is so much time and resource and effort is spent arguing about allocation, instead of trying to promote organ donation, which would eliminate the entire problem," Sorensen said.
The Organ Procurement and Transplantation Network has been ordered to set policies allocating organs first to those with highest medical urgency status, with less reliance on geographical factors. Currently, patients in some areas wait five times longer for organs than those in other areas.
Each transplant center has its own criteria for deciding when someone is placed on a waiting list. The network has been told to develop uniform, medically objective criteria for all the centers to use.
The centers must also use the same criteria for determining the status of people on waiting lists, to create a "level playing field."
The regulation includes a 60-day comment period and will be effective in 90 days. The network has another 60 days to propose new criteria for livers and a year to develop criteria for other organs.
Written comments on the new regulation should be addressed to Jon L. Nelson, associate director, Office of Special Programs, Health Resources and Services Administration, Parklawn Building, 12420 Parklawn Drive, Rockville, MD 20857.