Closing the gap on supply and demand for organ donation

HHS Secretary Tommy Thompson vows to increase organ donations but avoids stirring up a long-running controversy over regional vs. national allocation of organs.

By Susan J. Landers, amednews staff. March 12, 2001.

Washington -- Just days into his tenure as Health and Human Services secretary, Tommy Thompson announced the launch of a campaign to raise awareness of the need for more organ donations.

The former Wisconsin governor intends to duplicate at the national level his enviable record of increasing his state's donation rates. An initiative included in the secretary's action agenda for his first 100 days, it is also Thompson's first national attempt to build commonality on a subject -- organ procurement and distribution -- that has long been a source of discord.

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The national waiting list for organs now holds 74,570 names, according to the United Network for Organ Sharing. Those waiting for kidneys number 47,902 and for livers, 17,295. Another 4,184 patients are awaiting new hearts. And, although the number of donations increased by 59% between 1990 and 1999, the number of patients awaiting organ transplants skyrocketed more than five-fold, according to UNOS' Year 2000 annual report.

And it is clear that Thompson's high-profile effort to close the supply-and-demand gap and dramatically increase the number of available organs could help keep at bay a controversy that has raged in the transplant community since efforts to revamp the system for allocating lifesaving organs began.

This controversy, dormant for the time being, was touched off by a 1998 federal proposal -- designed to equalize waiting times patients face across the country -- that abolished geographic restrictions for distributing organs. Critics said the rule would create a national waiting list and result in lost lives and wasted transplant opportunities. They also maintained that such policies should be guided by transplant experts rather than government regulation. Meanwhile proponents saw the rule as a way to encourage broader sharing.

The controversy found then-Gov. Thompson squarely at odds with his HHS predecessor, then-Secretary Donna Shalala, PhD. Thompson favored maintaining geographic restrictions and filed a lawsuit to stop HHS's efforts in March 2000. The suit was dismissed on a technicality.

The number of organ donations rose 59% from 1990 to 1999, while the need grew fivefold.

In announcing his new donation campaign, Thompson said, "What we need to do, instead of taking from one to another, is to grow the number of donors."

Physicians and patient advocacy groups cheered Thompson's announcement. The AMA congratulated Thompson on his commitment. The Association has also initiated its own organ campaign aimed at educating physicians about the need for organ donations and encouraging them to become donors themselves.

"I'm thrilled to death," said Phil Berry, MD, a Dallas orthopedic surgeon who had a liver transplant 14 years ago. Dr. Berry, a past president of the Texas Medical Assn., spearheaded the Texas "Live and Then Give" organ donation program, which became one of the models used by the AMA. "I think anything we can do to get this subject before the public and talked about in a positive way is going to decrease the number of patients on the waiting list," he said.

Meanwhile, Ayaz Samadani, MD, president of the Wisconsin Medical Society, witnessed firsthand Thompson's state success and is enthusiastic about his national effort. "The governor brought a passion to the cause," he said. Dr. Samadani made organ donation awareness the theme of his presidency as a tribute to his friend, Pakistani-born musician Nusrat Fateh Ali Khan, who had end-stage renal disease and died in 1997 at age 49.

Still, the question of the government's role in organ transplantation and how patient need and organ location factor into transplantation decisions will likely continue to percolate in the background.

The 1998 regulation, which faced congressional scrutiny before finally being accepted, has been in effect for about a year, but very little has changed in allocation procedures. As before, patients waiting for an organ in the same geographic area as a donor are generally given priority over patients waiting at a more distant point, even if the more distant patient is sicker.

Thompson has the authority to take action to change the rule but, so far, has only said he "will review it in time," said John Nelson, who oversees HHS's Health Resources and Services Administration transplantation division.

Right now Thompson would like to deal with the "more urgent problem of saving lives, and that can be best dealt with through a concerted effort to increase the number of people who agree to donate," said Nelson.

However, the 1998 rule has resulted in at least one proposed change. UNOS and the Organ Procurement and Transplantation Network have developed a new system for prioritizing patients awaiting liver transplantation.

"A much better instrument"

Although the system does not directly touch upon the geographic distribution issue, it is an attempt to better identify and target priority for liver transplants for those patients who truly are in more urgent need, said Joel Newman, a spokesman for UNOS, which works under contract to the government. UNOS had registered vehement opposition to the rule in the past, but now is working within the guidelines of the new regulation, which is "embodied in our contract," he said.

The system would heighten the importance of clinical characteristics in assessing a patient's condition and allow transplant centers in different parts of the country to more accurately compare their patients.

The system came out of the Mayo Clinic, Nelson explained, where it was called the Mayo End-Stage Liver Disease Scoring System, or MELD. The system is now called the Model End-Stage Liver Disease Scoring System, and is still referred to as MELD.

The system change was called for by the rule and is now under review at HHS. Although it still must be tested, "it is a much better instrument to determine whether a patient will benefit from a transplant," said Nelson.

The mechanism currently in place to prioritize patients allows for more subjective interpretation of a patient's condition. "There were a lot of concerns over the past several years that the transplant programs have not been following the rules as closely as they should," said Nelson.

And the controversy over the geographic allocation of organs has not disappeared. Lisa Rossi, spokesperson for the University of Pittsburgh, was critical of the UNOS proposal for failing to address the larger issue of the sharing of organs more broadly. "They are taking little mini-steps," she said.

The proposal will likely be reviewed in June by a new 20-member Advisory Committee on Organ Transplantation, which was appointed by former HHS Secretary Dr. Shalala shortly before she left office.

The committee, chaired by Nancy Ascher, MD, PhD, a liver transplant surgeon and professor of surgery at the University of California at San Francisco, was recommended by the Institute of Medicine in a congressionally mandated report. Among its members are 10 physicians, including transplant surgeons.

The committee will also review the collection and dissemination of data as well as several other scientific, medical, public health, coverage and ethical issues.