Government may develop new organ guidelines
Access vs. allocation issues dominate debate
(Editor’s note: The following story is the first in a two-part review and analysis of the current ethical dilemma surrounding organ donation and liver transplantation. In next month’s issue, Medical Ethics Advisor will look at how both public and private insurance determines whether a patient gets a transplant and how your ethics committee can and must help solve the wider ethical problem of a lack of organ donation.)
Since 1986 when Congress enacted the National Organ Transplant Act, federal policy has prohibited the allocation of human organs for commerce and precludes patient selection for transplantation based on political influence, race, gender, financial or social status. But as the number of patients awaiting these life-saving procedures grows, the number of donor organs has stayed the same, prompting questions about how to allocate the few organs available.
The debate is between two diametrically opposite groups: those who say more patients, especially the economically disadvantaged, have greater access and better quality of life during the process if transplants are available at centers closer to home, and those who say that allocation of scarce organs requires a national system that gives these resources to the sickest patients first. Many of these patients are at the larger transplant centers, which would leave the smaller, regional centers without organs or patients.
One major obstacle in resolving the access vs. allocation issue is that the transplant centers and physicians involved must consider another element: money and financial survival.
Organ allocation is an ethical dilemma and public policy issue that is likely to continue as long as there are more patients who need organs than there are donors, says Phyllis Weber, executive director of the California Transplant Donor Network in San Francisco. How can the federal government, organ procurement organizations, hospitals, and other entities improve current efforts to promote organ donation? This is one of many questions that the U.S. Department of Health and Human Services (HHS) seeks to answer.
The federal government held hearings at the National Institutes of Health in Bethesda, MD, in mid-December on the issue of liver organ allocation and organ donation. The HHS secretary will review the results of the hearing as well as written and other public comments received, and prepare a final rule within three months, according to Philip R. Lee, MD, assistant secretary for health for HHS, who chaired the hearings.
Any policy changes from HHS will come in the aftermath of recent proposed revisions in liver allocation guidelines announced in November by the Richmond, VA-based United Network for Organ Sharing (UNOS). The organization operates under a federal contract to administer organ procurement and transplantation policies and also maintains a registry of all transplant recipients nationwide.
Under HHS authority, UNOS administers the mandate for a national organ procurement and transplantation network (OPTN) while a separate 39-member board of directors develops and administers policies on organ allocation, procurement, and donor-recipient matches. It is this plethora of government bureaucracy, and a debate over who knows what is best for patients, that seems to obscure the discussion now under way.
In the patient’s best interest
After two years of debate among UNOS board members and others in the transplant community about allocation of all scarce organs, the organization announced its new three-part policy in mid-November on liver allocation. It is scheduled to take effect Jan. 20.
"Given the fact that a certain number of patients will die, we have to develop policies that minimize this number," explains Weber, who is also a UNOS board member. The change in UNOS policy was motivated by an attempt to save more lives, says O. Patrick Daily, PhD, assistant director of operations and head of the UNOS scientific registry on organ transplantation. (See synopsis of new UNOS liver allocation policy, p. 5.)
In 1994, the board of the Organ Procurement and Transplant Network announced a revised policy to allocate livers for transplantation but the proposed rules were never implemented. "The revisions proposed by the board have generated considerable controversy," reads an announcement of the December HHS public hearings.
OPTN’s proposed policy of 1994 would revise the definitions of several of the status groups for liver transplant patients and would alter the "local" area that constitutes the first allocation area.
Lives hang in the balance
As the lives of many transplant patients in small and large liver transplant centers across the United States hang in the balance, HHS will decide one of these three options: Accept and approve the UNOS recommendations, adopt the 1994 regulations proposed by the OPTN board, or develop and implement its own new guidelines.
The key will be to decide what is truly in the best interest of all patients. "We will not discover a best system because there is not one," said Todd Howard, MD, director of liver and kidney transplantation at Barnes-Jewish Hospital in St. Louis. "Each system being considered has advantages and disadvantages. We will simply change the names and addresses on the patients’ death certificates."
"Survival concerns must take precedence over quality-of-life measures, including cost/benefit measures," argued John Fung, MD, chief of transplant surgery at the University of Pittsburgh Medical Center (UPMC). Fung is urging HHS to institute an allocation distribution policy that creates a shared national list for livers, with top priority always going to the sickest patients.
Where are these patients? In 1988, there were 58 liver transplant centers, according to UNOS. Today there are 119. Florida and Georgia are two states with new programs. The number of liver transplants in these states has risen from 41 the first year to 354 in 1995. In 1988, 30% of all liver transplants were performed in Pittsburgh. In 1995, UPMC performed only 61¼2% of all liver transplants in the country.
Three ethicists were asked to serve as consultants to the HHS committee that may revise current organ allocation policies. Their questions often mirrored the ethical dimensions of the problem. "Is this a creation of inequality?" asked Nancy N. Dubler, LLB, director of the division of bioethics at Montefiore Medical Center in Bronx, NY. "Are patients encouraged to come [to larger transplant centers] on the false hope that they will be transplanted? Do these centers tell patients that they are less likely to receive a donor organ than if they were transplanted elsewhere?" she asked at the HHS hearings.
Transplant centers like the UPMC contend that patients come to larger centers and physicians refer to the larger centers because of their success rate.
Where do poorer, more disadvantaged patients receive transplants? Do they have equal access? At the University of Medicine and Dentistry of New Jersey in Camden, nearly one-quarter of all liver transplant patients are uninsured, Baburao Koneru, MD, chief of transplantation told the panel. Nearly 60% of the organs procured in the state are dedicated to New Jersey patients, he said.
At the Medical University of South Carolina in Charleston, a quarter of all local liver transplant patients come from minority populations. "Without programs like ours, these patients will not have access to liver transplantation," said Prabhakar Baliga, MD, director of transplantation.
Then there are the candidates who simply never make it on a list, said Jeffrey C. Reese, MD, a kidney and pancreas transplant surgeon at Fletcher Allen Health Care in Burlington, VT. "When you think about the many people in small, rural areas like ours, who cannot go to Boston and who never get referred, who die without a transplant, you realize that access is more important than allocation," he lamented.
Both allocation and access to transplantation will be available only when organ donation increases, almost all of the participants agreed at the hearing. HHS’s Lee said he was seriously considering the possibility of more hearings in early spring to discuss donation strategies.
Transplant experts emphasize that restoring the public’s trust in transplantation is a key to increased donation. They argue it is time to turn the argument about fairness around and focus on the benefits of transplantation. Says Carol Fink, RN, an intensive care nurse at San Francisco General Hospital and a member of the hospital’s ethics committee, "In terms of benefit vs. harm, any patient who doesn’t get an organ dies without it."
You have reached your article limit for the month. Subscribe now to access this article plus other member-only content.
- Award-winning Medical Content
- Latest Advances & Development in Medicine
- Unbiased Content