Until recently I thought I had experienced virtually all the "bad" experiences in the world of liver transplantation. Recently, I had one of the worst and most frustrating patient-related experiences of my career.
Earlier, I had a meeting with the parents of a delightful 4-year-old girl who had exhausted all therapies to treat her liver cancer. I informed them we had an excellent chance to save their daughter with a liver transplant. I told them that we needed to get her "on the list" as soon as possible to ensure that we transplanted before the tumor spread outside the liver and became incurable.
One week later, I had to see the same parents and tell them that I could no longer feel sure that we would be able to find a liver in time to save their daughter. The reason is that the Secretary of Health and Human Services Donna Shalala said in late March that the national system for matching organ donors with potential recipients of those organs would be dramatically changed. This unprecedented move would replace the present system, which was created by a majority consensus of the entire transplant community, with one designed by the secretary. Simply stated, Shalala has decided that she is better qualified to decide who will receive an organ transplant than the members of the transplant community.
Up to this point, policies have been developed by the United Network for Organ Sharing or UNOS, a private corporation which was a contract with the federal government to oversee organ transplantation in the United States. UNOS, through its extensive committee structure, has representation of all members of the transplant community, including recipients, donor families, organ procurement agencies, transplant physicians and surgeons, nurse coordinators, ethicists, the lay public and other scientists.
Through its committee structure, UNOS has openly debated the development of organ transplant policies, which have been approved by a majority decision of the transplant community. All policies have been put out for public comment and the final approval given by the UNOS board of directors. HHS has, up to this point, simply overseen the implementation of these policies. Why now would the HHS secretary decide that she is more qualified to make organ transplant policy than the transplant community? While the issues regarding organ transplant policy are complex, the answer to the secretary?s involvement appears quite simple. As the demand for transplants has increased, predominantly with the expansion of the number of transplant programs, there simply are not enough donors to meet the needs of all potential recipients. This has led to an increase competition among transplant centers for the limited supply of donor livers.
When transplantation was in its infancy, several centers grew to very large size simply because they were the only places transplants could be performed. As the knowledge and technology has spread across the country, transplants are no longer confined to limited areas in the country. This has allowed patients to received transplants close to their homes and families.
However, as the limited number of available organs has also been spread across the country, these major transplant centers have watched the number of transplants performed steadily decrease. Because UNOS is an organization that represents all transplant centers, not just the special interests of the large metropolitan transplant centers, these larger centers tried, unsuccessfully, to force UNOS into policies that would favor the larger centers. Once they failed to change the present policies through the usual route, these larger transplant centers took an alternative route - using their political clout to influence the federal government to change the way it has been involved in organ donation over the last 20 years.
By performing an end run on UNOS, the organization that is supposed to represent all transplant patients and professionals, and putting political pressure on the federal government, these organizations are now unabashedly claiming victory. There is no doubt in the transplant community that Shalala?s decisions have been based on the political pressure applied by these large transplant centers.
Based on the available scientific data, the changes proposed by the secretary will reduce the number of first-time liver transplants, increase the number of repeat transplants, reduce the success rate of liver transplants, and dramatically increase the costs. For Houston patients awaiting a transplant, this policy will certainly have other far-reaching, negative implications.
The present system puts first priority on local use of donated organs before sharing with the rest of the country. Because Houston has, through its local organ procurement agency, LifeGift, made outstanding gains in the education of the public regarding the need for organ donation, Houston has become one of the country?s leaders in the number of organ donors, and therefore has increased the number of organs available to local patients. If the proposed system is implemented, Houston organs will no longer be available for Houston patients first. Our patients, in general, have been transplanted reasonably quickly, but under Shalala?s proposal, organs will be given to patients nationwide who have been waiting the longest and have the same medical need. This means a large number of organs will be leaving Houston but few will be returning.
Quite simply, this tragically will mean an increase waiting time in the Houston area for patients needing organ transplants such as hearts and livers and an increasing death rate of death for our patients awaiting lifesaving transplants. And the future remains uncertain for a little 4-year-old girl with liver cancer who will not "fit" Shalala?s criteria of who should receive a liver transplant.
Never before has the federal government unilaterally decided on a policy which has had such far-reaching implications on a medical procedure. If there were a shortage of parts for cars, would the federal bureaucracy preferentially send parts to only those automobile manufacturers that were the largest or the oldest or had the best political connections? This appears to be exactly what Shalala is doing with the limited supply of donor organs.
By bypassing the transplant professionals who have always made and implemented policies related to organ transplantation, the secretary has greatly overstepped her bounds. Unless this situation can be rectified, organ transplantation policies will no longer be decided by the professionals in the field but by those who have the most political influence.
(Appeared in the Houston Chronicle Section A Page 25, Thursday April 9, 1998)
TLC Update:
The period for public comment was extended to August 31st, and the date of the decision for implementation was moved to October 1st. On June 18th there was a joint Congressional hearing for Congress to investigate its role in the decision making process.
