WASHINGTON - Randy Creech of Houston, Texas was told eight years ago that he had a year to live after his doctor diagnosed a viral infection in his heart that was quickly depleting its ability to function. Six months later he received a heart transplant from a 19-year-old boy who died in a hospital in his home state.
Creech's experience mirrors that of many others receiving transplants in the United States: organs that are harvested are first offered to local residents in need.
If the federal government has its way, this system will be overhauled to increase the sharing of organs across state lines and decrease what HHS Secretary Donna E. Shalala calls the "current geographic disparities in the amount of time patients wait for an organ."
Shalala points to 1997 federal data that shows that although the neediest patients across the country have comparable waiting times, patients deemed to be least needy may wait for a liver transplant for two months in Milwaukee or Kansas City, Mo., but over two years in Boston or Philadelphia.
Fighting the regulation, which is to go into effect Oct. 21, is the government contractor that oversees the current allocation system, nearly a dozen states, most organ transplant centers and many concerned doctors and patients.
They say the current system works, and the effort to change it is due to heavy lobbying from large transplant centers who would gain financially from the federal changes.
"Our detractors say the system is broken, but we think it works very well. The sickest people already receive highest priority," said Bob Spieldenner, a spokesman for the Richmond, Va.-based United Network for Organ Sharing (UNOS), the government contractor that oversees the allocation system. He said that 85 percent of the 20,000 public comments received by HHS on the proposed regulation so far express opposition to it.
Spieldenner thinks the new regulation comes down to "a political appointee deciding organ allocation policy."
Heart recipient Creech, who is active in organ donor outreach and visiting patients awaiting organs in Houston, said the current system gives all patients in a local area the chance to regain their health.
"People need to be reminded that anyone on the transplant list is very, very sick. It needs to be even across the board," Creech said.
As of mid-April, nearly 41,400 individuals were waiting for organ transplants around the country. HHS said that although 20,000 Americansabout 55 each dayreceive transplantation, about 4,000 people10 each daydie while awaiting a donated organ.
UNOS administers the national Organ Procurement and Transplantation Network (OPTN), which was established by the National Organ Transplant Act of 1984. The Health Resources and Services Administration, a health and human services agency, draws the regional lines that make up a network that consists of 60 different areas in 11 geographical regions.
When a patient needs an organ, he or she is placed on a waiting list in the local area or region. A patient can also choose to be listed at a transplant center in another state to improve their chances of receiving an organ, but if an organ is available at that location the individual must travel there, which can involve personal expense.
When an organ is donated, it is first made available locally to candidates in descending order of medical urgency before being offered to patients regionally or on a national basis. UNOS policy states that "all patients have a fair chance at receiving the organ they need - regardless of age, sex, race, lifestyle, religion, financial or social status."
The Department of Health and Human Services disagrees.
"Patients who need an organ transplant should not have to gamble that an organ will become available in their local area, nor should they have to travel to transplant centers far from home simply to improve their chances of getting an organ," Shalala said. "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."
The federal regulation, announced in April 1998, would require the network to develop criteria to decide when a patient is placed on the waiting list for an organ, and to develop "medically objective, uniform criteria" for determining the medical status of patients who are listed.
Last year, Oklahoma, Louisiana, South Carolina, Wisconsin and Ohio adopted resolutions or laws that fly in the face of the federal rule. The new laws provide that organs donated in a specific state first be made available to residents awaiting transplants in that state. This year, Arizona, Kansas, Missouri, Nevada, Tennessee and Texas are considering similar legislation.
Louisiana directed its attorney general to challenge the legality and constitutionality of the federal regulation. A lawsuit ensued that said the final rule is in violation of the due process clause of the Fifth Amendment because it infringes on Louisiana donors' rights to make their own decisions about how to dispose of their remains after death.
Filed in the U.S. District Court for the Middle District of Louisiana, the plaintiffs, which included state medical schools and the Louisiana Organ Procurement Agency, also argued that the 1984 National Organ Transplant Act does not give Shalala authority over organ allocation decisions. The judge imposed an injunction on the federal rule, which was to take effect last October.
Because of the controversy, the 1998 federal budget bill included a rider postponing implementation of the new federal rule until this October. Congress called on the Institute of Medicine, in consultation with HHS and with transplant network, to study the current policies of organ allocation. IOM is scheduled to issue its report in late summer or early fall. The judge in Louisiana has retained jurisdiction over the matter pending the outcome of the federal study.
Shalala "is changing Congress' intent that the medical community make policy," said Louise Jacobbi, executive director of the Louisiana Organ Procurement Agency.
Jacobbi said that as medical science has moved forward, so have policies of the organ transplant community. Livers, the organs often at the center of the debate, are only viable for 12 to 18 hours, and thus can only be transported short distances. Jacobbi said OPTN has recently changed its liver policy by establishing the standardization of medical and listing criteria for patientsone of the directives that the federal regulation called for.
That means that a "status one" patient falls under the same medical definition whether that patient lives in New York, New Orleans, Miami or Richmond, Va.
"The entire process is evolving, it is dynamic and has been since we put it in place. Can we move faster, maybe yes, maybe no. We are trying to get consensus from 300 transplant centers," Jacobbi said.
Some large organ transplant centers with good reputations and long waiting lists, such as the one at the University of Pittsburgh say that UNOS is not acting fast enough.
"Level the playing field that is exactly what we feel should be done. (The current system) favors people who by chance happen to be in the right geographic area, and disadvantages people who are at centers that have long waiting times. People in Pittsburgh are penalized," said Lisa Rossi, a spokeswoman for the University of Pittsburgh transplant program.
Rossi denies that the University of Pittsburgh is pushing for the regulation for its own financial gain. "Who knows what the impact will be on our center," she said.
Rossi said that although UNOS has made some changes, "it is a very long, arduous process" that can take months and years to enact.
Most smaller transplant centers don't agree with the viewpoint of giants like the University of Pittsburgh.
"We think (the federal regulations) would be disastrous for most locations in the country. A number of small to medium-size transplant centers would be shut down," said Sam Holtzman, chief executive officer of Life Gift Organ Donation Center, an organ procurement organization that is responsible for collecting and distributing organs to transplant centers in Houston, Ft. Worth and West Texas.
"You are not increasing the supply of the organs with these rules. They mean that more people will die in Texas and fewer will die in Pittsburgh. And that is a silly way to do things," Holtzman said.
If the federal rule is enacted, it becomes effective 90 days after publication in the Federal Register and the transplant network would have another 60 days to propose new criteria for livers, and a year for development of criteria for other organs.
More organs needed
A 1997 report from the OPTN shows that the median waiting time for the neediest liver patients was almost equal across the 11 regions, ranging from two to seven days. But, for liver patients deemed to have the least medical urgency the waiting time varied from 105 days in region 3 to over three years in region 2. Or, on a more local level, the largest discrepancy was 52 days in Milwaukee, Wis. compared to nearly two and a half years in Philadelphia.
UNOS looked at 16 other modeling formulas that could be used for the basis of liver allocation, and chose to stay with the current system.
"Fundamentally it looked like the current system was still best," Jacobbi said.
Some of those in the organ transplant community advocate increasing organ donations rather than focus on revamping the current system.
"We keep working on the symptom and not the problemthe shortage is the big problem. It is disturbing to me to see people die waiting," said Creech.
Last week, HHS and UNOS announced that the number of organ donors increased 5.6 percent in 1998from 5,479 donors to 5,788 donorsthe first substantial increase since 1995. An initiative launched by the Clinton administration in 1997 has emphasized the need to inform family and others about one's decision to be a donor.
Interested donors can specify so when applying for a driver's license. The next of kin would then be contacted before their organs were harvested for transplant if they were to die.
In 1994, Pennsylvania became the first state that no longer requires hospitals to ask the family for consent if the deceased had an organ donor card.
The Keystone State plans to begin a three-year pilot program as early as September that would make organ donors eligible for $300 in state funeral benefits. The incentive program is believed to be the first of its kind in the nation.
Creech worries that the federal regulation would interfere with local outreach efforts, which gives transplant centers motivation because the organs received can then be offered first to local patients.
"It would be disturbing to see an organ donated in the local hospital to go thousands of miles away," he said.