Jan. 14, 2000 (Boston) -- Approximately 4,000 Americans die each year while waiting for an organ transplant, but a proposal for revamping the current system could help ensure that the most critically ill patients get top priority, say researchers from the Institute of Medicine (IOM).
Although some critics have expressed concern that distributing organs across wider geographic areas or larger populations might make the current organ shortage even worse or harm economically disadvantaged patients, a review of records on about 33,000 patients on waiting lists for liver transplants suggests that a broader-based system would be more fair, write Robert D. Gibbons, PhD, and other members of the IOM's committee on organ procurement and transplantation. The IOM was commissioned by Congress in October of 1998 to study whether organ procurement regulations proposed by the Department of Health and Human Services (HHS) would result in a more equitable distribution of donor organs.
The IOM committee members determined that under the current system, which is composed of 63 nationwide organ procurement organizations (OPOs), organs that could go to "status 1" patients -- those who are expected to die within 1 week without a transplant -- frequently go to patients who are less critically ill, including those who are not at risk for imminent death. Specifically, the IOM researchers found that only about half of status 1 patients received organs, 9% died while on the waiting list, and the remainder were shifted to other status categories such as "too ill to undergo transplant." The IOM report appears in the Jan. 14 issue of the journal Science.
"The system is not currently efficient, because in the smaller-volume, smaller population-area organ procurement organizations, the rate of transplantation of the status 2b and 3 patients, the less severely ill patients, is much, much higher than it is in the larger areas," says Gibbons, professor of biostatistics at the University of Illinois at Chicago. "What happens is that patients who are status 1 or 2a are in severe medical need for a transplant, but somebody who is a status 3 in a small OPO is getting that organ."
Under the regulation in question, proposed by the HHS in April 1998, the current system of regional organ distribution would be revised, as the regulation states, to "assure that allocation of organs will be based on common medical criteria, not accidents of geography." The "Organ Procurement and Transplantation Network: Final Rule," or "Final Rule" for short, calls for enhanced federal oversight of organ procurement, increased public access to important information, and shifting of emphasis away from geographical considerations to medical needs.
But implementation of the Final Rule has been held up by political wrangling. In October 1998, Congress suspended the regulation for one year and asked the IOM specifically to study the issue and come up with recommendations. Then on Dec. 17, 1999, President Clinton signed into law the "Ticket-to-Work and Work Incentives Improvement Act of 1999," which, against his administration's wishes, included a 90-day moratorium on implementation of the Final Rule that had been slipped into the legislation by Senate Majority Leader Trent Lott, R-Miss.
The earliest the new regulations could go into effect would be mid-March 2000, but further delay is likely as Congress plans to reconsider the issue as part of a bill to reauthorize the National Organ Transplant Act.
Congress, with the support of many of the nation's transplant surgeons and centers, may consider legislation that would strip the government of much of its current authority over organ procurement. Such legislation would fly directly in the face of the IOM recommendations to Congress.
Politics in Washington and in the field of transplant medicine are fueling debate over the proposed changes. "The issue regionally is competing OPOs," says Frederick Gordon, MD, director of hepatology and medical director of the liver transplant program at the Lahey Clinic in Burlington, Mass.
In an interview with WebMD, Gordon says that he generally supports the Final Rule, but understands why some OPOs are nervous about the prospect of change: "I think there's some potential for improvement in areas where there are OPOs that are geographically close and are competing for the patients in the same distribution region. If there are some changes, however, there is a risk that if you're going to abolish competition among OPOs and there's a massive program in the same city with a tiny OPO, that little program is going to go out of business."
Marsha Jacobson, chief operating officer of the New England Organ Bank, says, "What is being proposed is very similar to what we have been doing for a long time in New England, which is wide sharing of organs, and we believe it works for donor families, and for recipients, so I think there's a lot to be said for [the proposed HHS regulations]."
"In essence, you don't even have to change the organ procurement organizations -- all you have to do is to promote broader sharing amongst them," Gibbons tells WebMD. He says that initial concerns about the HHS rule came about largely through misunderstanding of how the system would be revised. "People thought that there was going to be a national system and that livers, hearts, and lungs would be flown from Maine to California, which of course is ludicrous, given [the length of time an organ can be kept on ice before it begins to deteriorate]. I think we couldn't have asked for a nicer result for the analysis to come out and show that as soon as the population base hits about 9 million people, all of the 'geographic inequities' tend to go away. This is a very simple solution and it's not hard to implement it."
Meanwhile, approximately 62,000 people are waiting for donor organs, and a new name is added to the list every 16 minutes.