Armed with a supportive report by an independent scientific panel, the Clinton administration is asking Congress to allow its policy on organ transplantation to take effect.
"I hope you will read the report," Health and Human Services Secretary Donna Shalala wrote in a letter sent to every member of Congress. "It is thoughtful, balanced and clear."
The report by the Institute of Medicine, an arm of the National Academy of Sciences that frequently advises the government, essentially supports the administration's approach to allocation of scarce organs for transplant. For its part, the other side wrote its own letter to Congress, focusing on a few areas where the report supports its concerns.
"The Department of Health and Human Services should go back to the drawing board with the transplant community and agree on new policies that will benefit all patients," wrote Dr. William D. Payne, president of the United Network for Organ Sharing, which runs the nation's transplant system under an HHS contract and strongly opposes the HHS policy.
The essential problem is supply and demand: There were nearly 21,000 transplants performed last year but more than 4,800 people died waiting for a new organ.
At issue is how to distribute donated organs among some 65,000 patients now waiting for transplants.
The transplant network and much of the transplant community supports the current system, which relies heavily on geography. Organs are offered locally first, then regionally and then nationally -- meaning a relatively healthy patient who is located close to the organ donor often gets offered an organ before a sicker patient elsewhere.
Last year, the HHS issued regulations directing the network to remake its system and give organs to the sickest patients first.
The network objected -- both to a new system and to HHS telling it what to do -- and lobbied Congress for a change. Congress put the rule on hold for a year and asked the Institute of Medicine to study the issue.
In the meantime, the HHS has been negotiating with transplant surgeons and hospitals and plans to issue a revised version of its regulations within weeks. The network agrees the discussions have been productive.
A moratorium on the rule's implementation expires Oct. 21, and the HHS is asking Congress to let it take effect.
"I believe the report...puts to rest the misunderstandings and misrepresentations that have surrounded our recommendations," Shalala wrote to members of Congress last week.
The report recommends that the regulations be implemented by establishing larger areas for the sharing of livers, the organ that has generated the most controversy.
It agreed with the HHS that the department should take an active role in overseeing the transplant system. And it said the network should make more data available more quickly, affirming another aspect of the HHS rule.
But it did not totally support the department. The HHS has ited disparities in the length of time people must wait for transplants as one of the chief reasons for remaking the system. But the Institute of Medicine said that waiting time is a misleading indicator.
The network is seizing that point to argue that the entire HHS rule is wrongheaded.
"The Institute of Medicine has questioned the basic medical premise of the pending federal organ transplant regulations," Payne wrote last month, the day after the report was released. "Therefore, the regulations should be withdrawn."
Written By Laura Meckler