Who wins, who dies?

Congress must stop fighting about transplant regulations and deal with the real problem: the shortage of donated organs.

By David McGuire
Published April 14, 2000 4:00PM (EDT)

It's a shame that the stakes in the mounting congressional battle over organ transplantation are so high. The debate -- rife with entrenched interests, dueling ideologues and convoluted loyalties -- has the trappings of high theater. But the outcome will be measured in lives, and combatants on both sides are gravely concerned that lawmakers will get it wrong.

"Something to the tune of 4,000 to 5,000 people a year will die waiting for an organ," says Mark Rosenker, an executive and lobbyist for United Network for Organ Sharing, or UNOS.

In the simplest terms, the transplant fight boils down to this: How should scarce organs, especially livers, be allocated nationwide? Should they be given to people based on where they live, as happens now? Or to the sickest patients regardless of geography, as the Clinton administration has been pushing for two years?

The longer the tug-of-war goes on, however, the messier it gets. It has revived the argument of public vs. private control of health care and bogged down in an argument over states' rights. Several governors have leaped into the fray, unhelpfully, with "hoarding" laws designed to keep organs inside their borders. Beyond politics, the debate has raised touchy questions about how to decide who receives an organ and who is left to die waiting.

Rosenker says the number of deaths will increase if organs are allocated through the federal government instead of through doctors and a private administration system. The administration takes the opposite view -- that more people will die if organs continue to be distributed not necessarily to the sickest patients, but to people who live in a particular region. No plan -- and there are well-meaning proposals floating around as well as mean-spirited ones -- is likely to solve the real problem: There aren't enough donated organs for all the people who need them.

Earlier this month, the House of Representatives voted 275-147 to effectively kill the attempt by the Department of Health and Human Services to exert more control over transplantation. Co-sponsored by Rep. Michael Bilirakis, R-Fla., and Commerce Committee Chairman Tom Bliley, R-Va., the bill would have given even more control over transplant policy to the already powerful United Network for Organ Sharing, a private not-for-profit firm headquartered in Bliley's backyard. UNOS, which administers the national network for procuring and monitoring transplants, says the bill puts medical decisions where they belong -- in the hands of doctors.

"UNOS is made up of the entire transplant community," Rosenker says. "We have followed every transplant and what in fact happens during transplantation. The professionals and the guys who do this for a living make the best judgments."

But John Nelson, director of the Office of Special Projects at Health and Human Services, questions whether broad health decisions should be made by a private, nonprofit organization.

"It's a public health issue determining who receives a transplant," Nelson says. He bristles at the suggestion that Health and Human Services should stay out of the matter. Nelson is the department's point man on organ transplantation and has, along with Health Secretary Donna Shalala, been attacked heatedly by people in the transplant establishment.

"To protect a particular contractor through a statute is not in the best interest of the public," says Nelson, who contends that HHS simply wants to fix inequities in the current organ allocation policy.

Under that policy, each of the nearly 70,000 people on the nation's master waiting list for transplants is listed with at least one of 60 regional organ-procurement organizations. When a liver is donated in one of those regions, the local organization tries to find a recipient among the sickest patients -- called Status One -- on its list. If no match is found, the organization offers the liver to Status One patients in neighboring organizations that have sharing agreements with the original agency. If still no matches are found in Status One, the local procurement group moves down the list in its region, trying to identify a match with a less critically ill patient.

The approach, says UNOS, is based on established science and allows the sickest patients to get the organs they need (patients in Status One will die within hours if they don't receive a transplant) while also providing transplants to some less critically ill patients, who may stand a better chance of accepting organs and surviving long term.

But HHS disputes both the efficacy and the equity of the UNOS approach.

The problem, says Nelson, comes in areas where local transplant organizations do not have sharing agreements with neighbors. If a liver is recovered within a few miles of a Status One patient, but that patient has the misfortune to be listed with a different procurement organization, that patient may be passed over in favor of less critically ill people on the "right" list, Nelson says. The local organizations and regional alliances are, in effect, fiefdoms that have great sway over whether an organ leaves their jurisdiction.

In the case of donor livers, Nelson says, "What I want to do is assure some equity in the system." If a Status One patient is a good candidate for transplantation, the liver shouldn't go to someone who is a Status Three, Nelson says.

Health and Human Services made that case in 1998, when it first attempted to change the rules for organ transplantation. That proposal, which would have required organs to go to the sickest patients first, largely regardless of geography, were met with massive outcry from UNOS and others in the organ-transplant community.

Rosenker bristles at the suggestion that UNOS policies "waste" viable organs on fairly healthy patients. "Nobody is on that list because they want a new lung, a new heart or a new liver because it is a kind of nice thing to do. You go on this list because you need an organ or you are going to die," Rosenker says.

World-renowned centers such as those at the University of Pittsburgh and the University of California at San Francisco supported the proposed changes. But UNOS and other centers opposed the rule, claiming that the feds were moving to centralize organ procurement and transplantation, and squeeze physicians and local networks out of the process.

Congressional opponents of the rule tied it up in moratoriums until last month, when HHS instituted an amended rule.

The new rule backs down somewhat from the "sickest first" requirements of the initial draft, which even HHS now concedes were not entirely practical. Regional concerns do need to come into play, Nelson says, because the ischemic time of a human liver -- the time it can live outside the body -- is only about 10 hours. But the new rule requires UNOS to establish policies aimed at broader organ sharing, and it gives Shalala final say over those policy decisions.

While UNOS and others in the transplant community have portrayed HHS as wanting to ship organs thousands of miles across country to the absolute sickest patients, Nelson denies the charges, saying that HHS simply wants to make the system more fair. "There are certainly a lot better ways of doing it than using a state boundary," he says.

But many of the people closest to the transplantation debate say that equity shouldn't be the only consideration. Donna Wright, a UNOS employee and liver transplant recipient, says that "justice needs to be balanced with utility."

"Fairness resides in getting the most number of people transplanted and giving the most life years" to those patients, she argues. If that means facing the unpleasant reality that organs aren't always best used in the sickest patients, so be it, Wright says.

Wright was diagnosed in 1991 with the same chronic liver disease that killed football star Walter Payton. She received a transplant in 1994, after she had been given just hours to live.

As an African-American woman, Wright is part of a demographic that has some of the highest organ rejection rates. Because women tend to have higher antibody levels in their blood, they are more likely to reject donor organs. African-Americans also have higher than average rejection rates.

But Wright says the current organ-distribution structure worked for her, and she worries that a centralized approach based on need alone could undercut medical decisions and jeopardize patients' lives. "There are medical complexities that are hard to codify in a regulation or a statute," she says.

Liver patients like Wright are at the crux of the conflict, because for them, more than any other transplantation patients, time is critical. Unlike heart and kidney patients, who can be kept alive for substantial periods of time after going into failure through techniques such as pacemakers or kidney dialysis, patients with failing livers live under an imminent death threat. And unlike heart and kidney failures, which usually are preceded by years of warning signs, liver failure can strike otherwise healthy adults who eat a bad mushroom or have an adverse reaction to medication.

While most players in the transplantation debate seem to be acting out of a genuine belief that theirs is the fair way to decide who should be transplanted, one group of apparent villains has emerged.

In 1998, when Shalala and HHS first drafted the proposed transplantation rules, several states began passing laws that gave them the right to prevent organs from passing outside of their borders. Shortly after the rule was drafted, Arizona, Oklahoma, Tennessee, Texas, South Carolina and Wisconsin passed bills that gave state organ transplantation authorities final say over organ-sharing agreements. Louisiana had such legislation in place before the HHS proposal.

The most vocal advocate for states' organ rights has been Wisconsin, which not coincidentally is home to a large transplant center and has one of the highest organ-donor rates of any state. Wisconsin recovers organs from 30 donors per million residents a year. The national average is 21 donations per million.

"The governor feels that states [with poor procurement rates] should learn to collect more organs," rather than trying to tap Wisconsin's supply, says Tony Jewell, spokesman for Wisconsin Gov. Tommy Thompson, a Republican. In other words, tough luck if you live on the Wisconsin-Illinois border and happen to need an organ to stay alive.

While anti-HHS lobbyists are quick to point out that none of the states stops organs from going to needy patients outside of its borders, the so-called hoarding laws have added a mean-spirited tinge to the otherwise earnest debate.

Wisconsin organ-transplant surgeon Anthony D'Alessandro serves as director of Multi-Organ Transplantation at the University of Wisconsin, and was one of the chief supporters of the Wisconsin law. He says the Wisconsin legislation was not intended to prevent needy patients in neighboring states from receiving organs, but rather to protect Wisconsin's interests from being harmed by intrusive federal rules.

"We have never closed our borders to organs leaving the state or to patients entering the state," D'Alessandro says. "We share organs with the neediest liver transplants in the region."

As to the "sickest first" arguments, D'Alessandro says, "74.8 percent of the people who died waiting for a liver transplant" in a recent tracking survey were Status Three.

During the House debates on the Bliley-Bilirakis legislation, Rep. Bill Luther, D-Minn., attempted to tack on an amendment that would have overridden the state laws on organ transplantation, but it was roundly defeated.

Providing a spark of hope that reason may ultimately prevail in the transplantation debate, recently introduced Senate legislation appears to offer a solution that both sides -- and more important, the tens of thousands of people awaiting transplants -- can live with.

Introduced by Sen. Bill Frist, R-Tenn., who is also a physician, the bill would allow UNOS and the transplant community to make decisions about transplantation policy, but would force the organization to seek Shalala's approval for those decisions. When the two parties disagree on an issue, it would be referred to an independent commission made up of five members chosen by UNOS, five chosen by HHS and five selected by the nonpartisan Institute of Medicine.

The administration has reacted more favorably to the Frist proposal than it did to Bliley-Bilirakis, which Clinton threatened to veto if it found its way to his desk. More important, while neither the UNOS backers nor HHS has wholeheartedly endorsed the Frist bill, people on both sides of the debate have grudgingly applauded it.

But even if the Frist bill breezes through the Senate in the same way that Bliley-Bilirakis cruised through the House, the two Houses would still have to find a way to create compromise legislation from the two widely disparate bills.

And while the Frist legislation may offer the best chance of strengthening the utility and the fairness of the nation's transplantation network, the underlying organ shortage remains the real problem, agree people on both sides of the debate.

"It is not good enough just to be putting it on your driver's license. You must share that decision with your family," Rosenker says, pointing out that next week has been designated as an organ-donation awareness week.

Until enough people sign on as donors, no federal policy will stem the death count.

David McGuire

David McGuire is a reporter in Washington.

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