ORGAN TRANSPLANTS: Government Announces New Policy
"Diving into a controversy that has torn the elite community of organ transplant surgeons, the Clinton administration proposed new rules yesterday" for the allocation of organs for transplant. San Francisco Chronicle reports that "[t]he new rules would shelve the current system, which divides the nation into dozens of regions and gives local patients priority when distributing organs (Russell, 3/27). The administration believes the new rules will improve the nation's system and assure that distribution of scarce organs will be based on "common medical criteria, not accidents of geography." Under the new rules, created by Health and Human Services Secretary Donna Shalala, the private-sector group which coordinates transplants must "develop revised organ allocation policies that will reduce the current geographic disparities in the amount of time patients wait for an organ." According to Shalala, the nation's current system would be improved if organs went to the sickest patients first, regardless of where they live. "Patients who need an organ transplant should not have to gamble that an organ will become available in their local area. ... 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," she said yesterday (HHS release, 3/26). "My concern is that people are dying unnecessarily, not because they don't have health insurance, not because they don't have access to care, but simply because of where they live in this country," Shalala said.
While the "move is designed to resolve one of the most contentious and emotional medical issues in the nation by, for the first time, establishing specific federal guidelines governing the allocation" of organs, the Washington Post reports the new rules "drew an immediate attack" from the United Network for Organ Sharing, the organization "that coordinate[s] the nation's organ sharing system" (Weiss, 3/27). Richmond-based UNOS "decried the changes," the Richmond Times-Dispatch reports. "We think these regulations will have a dramatic impact on organ transplantation. It nationalizes what has been a cooperative, regional and local system," said UNOS Executive Director Walter Graham. "These regulations will effectively federalize UNOS (a private, nonprofit organization) if allowed to stand," he said. UNOS officials "argue that a national list will concentrate organ transplant in major cities and hurt poor patients who can't afford to travel," the Times-Dispatch reports. The group "hopes to spark a public outcry" and has asked the Virginia Legislature for help (Hostetler, 3/27). The New York Times notes Shalala has "declined to offer any specifics about what the new system should look like," giving UNOS "five months to devise a plan that will even out waiting times for donated organs across the nation." Graham said, "They're saying something like 'Bake a cake and it needs to taste good. Submit it to us and we'll tell you if it's OK. They are moving the decisionmaking out of the hands of doctors and into the hands of the federal government" (Stolberg, 3/27).
The new rules are backed, however, "by large transplant programs led by the University of Pittsburgh." The Post reports that the University of Pittsburgh, "a once-enormous transplant center that has suffered under the decentralization trend, [has] focused on today's waiting time disparities" (3/27). The new system means "patients' needs will finally be at the forefront," according to the university's medical center, which houses the world's largest transplant program (UPMC release, 3/26). Dr. Jong Fong, transplant surgeon at University of Pittsburgh, said, "What we hope that these policies will do is ensure that every American has equal access or likelihood of getting a transplant" (NPR, "All Things Considered," 3/26). "I know it is going to create a big political turmoil and a lot of outcries. But once people settle down, I think, they'll find that all the points that Shalala made are fair," he said (New York Times, 3/27). Patient advocates are supportive of Shalala's new guidelines. The National Transplant Action Committee said they "enthusiastically support" them because they will "uphold the fairness of the transplant system." The group's president, Craig Irwin, said, "The completion of the regulations marks a major victory for the thousands of patients now waiting for organ transplants across the United States. ... At least now we can guarantee that everyone will be treated fairly regardless of who they are or where they live" (NTAC release, 3/26).
San Francisco Chronicle reports that "[p]ioneering programs like those at Stanford University and the University of California at San Francisco stand to gain from the new rules, while small urban hospital transplant centers ... stand to lose" (3/27). "Surgeons at Sacramento's two organ-transplant centers predicted the demise of their programs" as the result of the new process. Like other small transplant centers, officials at Sutter Memorial Hospital and UC Davis Medical Center cautioned that under the new system they may not be able be able to do enough transplants to retain their federal certification. In addition, small centers argue that they "simply do not have enough very sick people on the waiting list to be eligible for those organs, Sacramento Bee reports. Dr. Michael Ingram, a heart transplant surgeon at Sutter said, "Tonight, if an organ is available at the UC-Davis Medical Center ... that would match this patient who lives in Placerville, we can bring this patient down and get him transplanted. If these new guidelines become adopted and that patient isn't in intensive care tonight, that organ might go to Los Angeles." However, Dr. Claude Fox III, acting administrator of the federal Health Resources and Services Administration said that "there is not data to support the fear among small centers." He said, "We believe that in some instances, patients will be much more likely to be able to get a transplant within their community because the donor pool is going to be bigger" (Griffith, 3/27).
Playing With Numbers
In addition, some doctors argue that giving sicker patients organs first is not always prudent medical policy. The Los Angeles Times reports doctors predicted the new plan would "result in fewer patients being transplanted with lower survival rates" (Cimons, 3/27). Former UNOS president Dr. Larry Hunsicker said, "One of the medical realities is the sickest patients often need to have multiple transplants, so the inevitable consequence of transplanting, in preference, the sickest patients, will be to use more second and third transplants and therefore, given the tremendous limitation on the number of organs, that fewer people will be able to be offered a transplant" ("All Things Considered," 3/26). The Times-Dispatch reports a study performed for UPMC by CONSAD Research Corp. found that the new rules "would save as many as 200 lives a year by offering organs to people who would not otherwise get them." But a competing study by UNOS found the new rules would result in "761 additional repeat transplants each year and that the overall survival rate after transplants would drop from 75% to 68%." However, notes the paper, the type of regulations enacted will do little to address the main problem --the shortage of organs. Of the 55,000 Americans waiting for organs, only 20,000 receive a transplant, and about 4,000 people die while waiting for organs (3/27).
Let's Talk About It
The public debate on the matter, however, is far from over. Shalala has given 60 days for public comment before the rules are final, and Sen. Bill Frist (R-TN), a transplant surgeon and chair of the Senate Labor and Human Resources health subcommittee, announced yesterday he will hold a hearing on the matter. "I have not taken a position on a specific allocation policy, because the impact of this regulation shouldn't be reduced to one particular organ or one particular center. ... The critical question, as this process moves forward, is what is the appropriate interaction between the government, the medical community and the patients," said Frist (Frist release, 3/26).