Enhancing Transplantation Medicine
in the United States
Presented by John Neylan, M.D.
July 17, 1997
Date posted on the Web: July 25,
1997
Thank you for the opportunity to
be here today and to present testimony on behalf of the American
Society of Transplant Physicians (ASTP). I am John Neylan,
President-Elect of the ASTP, and Director of Transplant Out-Patient
Services at Emory University.
The American Society of Transplant
Physicians is composed of 1,100 physicians, surgeons and scientists.
The practices and careers of our members focus on the broad
fields of transplantation medicine and immunobiology and span
across many medical and surgical specialties. The ASTP represents
the largest group of transplant professionals in the United
States.
We are pleased that
the Institute of Medicine (IOM) has invited a cross section
of professionals
and other interested individuals from the transplant community.
No single institution or organization can affect significant
change alone. If we are to continue to advance the field, it
will be accomplished only through a partnership among all interested
parties. The progress achieved over the past ten years is clearly
a result of this kind of collaborative effort. For example,
the volunteer-run Organ Procurement and Transplant Network
(OPTN) administered by the United Network for Organ Sharing
(UNOS) has developed a sophisticated national system for organ
sharing. The transplant community has persuaded the Congress
to extend anti-rejection drug benefits for kidney transplant
patients from 12 to 36 months under the Medicare entitlement.
There have also been steady improvements in clinical practice
which have reduced transplantation morbidity and mortality.
Surveys confirm that an overwhelming percentage of Americans
are aware of and are in favor of the "gift of life," though
family refusal continues to be a significant impediment. Required
request laws have been enacted in all 50 states. The organ
procurement organizations (OPOs) have been responding to increased
demands for efficiency and productivity and have consolidated
from 120 to 64. And finally, the funding for transplant-related
biomedical research at the National Institutes of Health (NIH)
has increased in the past decade.
As we have heard this morning, enhancing
transplantation requires a myriad of strategies including increasing
organ donation, developing fair and equitable allocation principles,
recognizing the concerns of special populations, building upon
scientific and technical advances, and securing adequate access
and funding for all patients in need of organ or tissue transplants.
I would like to build upon this morning's discussion by presenting
two very important and timely issues for your consideration.
First I will discuss the ASTP's development of standardized
listing criteria for determining when to list a patient on
the national transplant waiting list. Second, I will provide
a cursory review of the Society's assessment of the recommendations
put forth by the original Task Force on Transplantation as
a means in which to determine the public policy needs facing
us today.
Organ allocation,
without a doubt, has engendered the most contentious public
policy debate regarding
transplantation in years. Throughout this debate, it has been
observed that the variation in criteria physicians use to list
a patient for transplant has contributed to the inconsistencies
in waiting times among patients across the country. Furthermore,
there is concern that, because of long waiting times in certain
regions, there is a pressure on transplant programs to list
patients early, before they actually require transplantation,
a practice referred to as "waiting list inflation." While
many other factors contribute to these regional differences
including OPO productivity and the available supply of local
donors, the increasing discrepancy between the short supply
of donor organs and expanding list of patients in need has
spurred a growing demand to ensure that the organ allocation
system is efficient and equitable.
In early 1997, the ASTP successfully
joined transplant physicians, surgeons, government agency representatives,
UNOS, patients, ethicists and managed care providers on the
NIH campus for a series of organ-specific conferences. These
conferences addressed the scientific basis supporting specific
minimal listing criteria. Transplant programs were surveyed
before each conference to identify areas of consensus and areas
of controversy. The initial work in this area by UNOS provided
the spring board from which the Society has subsequently developed
recommendations for national, standardized criteria for placing
patients on the organ-specific transplant waiting lists.
I would now like to discuss areas
of basic science research in transplantation that deserve your
attention.
Time does not permit me to review
each of the listing criteria, however, a set of these has been
made available in your handouts. A few key points are worth
noting. It was agreed by the participants of the conferences
that when a program places a patient on the waiting list, it
should signify that the program would be prepared to transplant
that patient immediately. Patients should not be placed on
the waiting list only because it is perceived that he or she
will likely need an organ transplant at some indeterminate
point in the future. It was agreed that the minimal listing
criteria should be simple, practical, based on existing published
or, in some cases, unpublished clinical research, and have
received broad agreement among the transplant community. The
criteria should be readily verifiable and regularly reviewed
to be modified where appropriate.
Recently, a modified version of
these recommendations was approved by the UNOS Board of Directors.
These and other steps must be taken if we are to maintain the
public's trust in the organ allocation system. This trust is
absolutely essential if altruistic organ donation is to grow
to the levels required to meet the needs of transplant recipients
in the future. The consensus-building process used in the development
of these listing criteria is an example of how the system can
work. The ASTP encourages the IOM to carefully scrutinize the
process for establishing public policy in organ allocation
and other areas. We support an approach, where those actively
involved in transplantation come together to review scientific
evidence, reach a consensus, and make recommendations.
As I mentioned in my introduction,
the ASTP, in it's own efforts to forecast the future needs
of transplantation, conducted an internal review of the Task
Force on Transplantation's recommendations. As you are aware,
the Task Force was created by statute with the passage of the
National Organ Transplant Act in 1984. We believe the more
than 70 recommendations put forth by the Task Force presents
a national blueprint from which most public policy decisions
have been made in the past decade. From a public policy perspective,
we felt much could be learned from revisiting these recommendations
to determine what has been accomplished, what remains a work
in progress, and what has been left undone.
The ASTP Public
Policy Committee and the Board of Directors recently completed
a position paper
that created a "scorecard" that compared 1986 Task
Force recommendations with the state-of-the-art today. Each
of the recommendations was reviewed and scored according to
present day results. Enclosed in your handouts, is a copy of
the ASTP's White Paper on Transplantation which reviews our
conclusions and describes areas of needed improvement. The
White Paper addresses four specific areas: organ donation,
organ allocation, access to transplantation and biomedical
research. Our agenda is ambitious, but, we are confident that
each and every recommendation is attainable. In the remaining
time, I will outline a number of key points.
1. Organ Donation:
The transplant community
is acutely aware that nearly 10 patients die each day while
waiting for
an organ. Despite improvements in the organ retrieval system,
allocation simply has not kept pace with demand. In 1990, there
were 21,914 patients on the waiting list; today, there are
over 51,000 patients on the waiting list representing an increase
of 133% over six years. Tragically, the number of donors has
increased by only 43% over the same period. The reasons for
the lack of transplantable organs are numerous, but family
refusal as I mentioned earlier is the leading cause for the
loss of potential donors, averaging over 40%. Recently, the
Institute of Medicine recommended that, "Increasing the
donation of kidneys receive the highest priority in the coming
decades."
The ASTP urges federal and state
governments, providers, professional organizations and patient
communities to work together in translating the extremely high
public awareness of the benefits of organ donation into a pro-active
national effort to increase the actual practice of this altruistic
act.
2. Organ Allocation:
Many of the Task Force organ sharing
recommendations have been implemented through a single, national
OPTN. UNOS continues to work towards a fair and equitable national
allocation scheme, however, as we have noted, there are still
unresolved questions and problems. The ASTP proposes:
- The Scientific Registry should
develop policies to make the system more user friendly concerning
access to data and its use.
- A mechanism is needed to minimize
the persistent problem of organ discard rates. In 1995, 1,200
kidneys, 500 livers and 250 hearts were procured and ultimately
discarded.
- The Task Force recommendation
to regionalize histocompatibility typing should be implemented
to reduce unnecessary and duplicative effort and expense.
- The Congress needs to embrace
the OPTN guidelines developed by UNOS and enact long overdue
legislation to reauthorize the Transplant Act so that authority
will finally be in place to appropriately administer the
system of organ sharing.
3. Access to Transplantation:
The issues surrounding access to
transplantation are complex and controversial. To build upon
and enhance the existing system we propose:
- Uniform medical listing criteria
for each solid organ category (heart, liver, lung, pancreas
and kidney) should be developed. Patients who meet the accepted
criteria should be allowed access to transplantation, regardless
of their ability to pay. As managed care grows, the ASTP
sees a need for the federal government to assert its leadership
to assure that each managed care plan provides equal access
to transplantation.
- The government should extend
Medicare coverage and payment for anti-rejection drugs for
the life of the graft.
- With Medicaid reform, the federal
government should assure that all states have uniform eligibility
and coverage criteria for transplantation.
- To ensure that patients make
informed choices regarding transplantation, the HCFA and
private insurance carriers should annually advise patients
of their treatment options.
- National education
programs targeted to minorities should be developed to educate
these under-served
groups about the "gift of life" as well as the
medical consequences of a transplant. It is imperative that
there be a thoughtful review of previous minority education
programs coupled with this effort.
- There is disturbing evidence
that transplant recipients experience employment discrimination.
The Congress should schedule hearings to determine the extent
of discrimination in employment, insurance coverage, etc.
and move to amend the Society Security Act, the job training
program, and the Vocational Rehabilitation Act to eliminate
such discrimination and design programs to ensure appropriate
access to employment medical benefits.
- The special issues and specialized
needs of children should be given a high priority. All funding
sources, including Medicaid and Medicare, private insurance
and HMOs must recognize the additional costs necessary for
the appropriate provision of transplantation care to children,
particularly infants and the very young.
4. Biomedical Research:
Research is central to all of the
transplantation issues previously addressed. We submit that
increased funding for transplantation research will lead to
solutions that will save lives. Both the Task Force and an
IOM report recommended that research receive high priority.
While research initiatives since 1986 have made progress in
all of the areas cited by the Task Force, the ASTP believes
that we are now on the threshold of many important breakthroughs
in the areas of rejection-immunosuppression, tolerance and
xenografts.
Next to issues related to the supply
of organs for patients on the waiting lists, those of basic
and clinical research are of the highest priority. Clinical
and basic transplantation funding at the NIH must be increased.
We propose that Congress, through the authorization and appropriations
process, expand the general transplantation research authority
of NIH. In particular, we recommend that Congress designate
a number of high priority initiatives at the NIDDK, the NIAID
and the NHLBI. We also recommend that the NIAID be designated
as the lead coordinating institute for the NIH transplantation
research effort in the next decade, The Decade of Transplantation.
I have submitted a copy of the White
Paper for this hearing's record. We plan to distribute this
paper to members of the Congress, selected government agencies,
and others in the transplant community. The ASTP invites the
IOM and all other interested groups to comment and reflect
on the recommendations presented in this white paper. We would
welcome the opportunity to work with the Institute to publicly
explore these issues further. I urge each of you to read the
document. We believe it is a blueprint for The Decade of Transplantation.
The ASTP is enthusiastic about the
potential for a variety of important studies on organ transplantation
in the United States today. We strongly endorse an IOM study
that would evaluate the field, identify problems and trends
and suggest solutions. It has been more than ten years since
the Congressionally mandated (PL 98-507) Department of Health
and Human Services report of the Task Force on Organ Donation
issued its report and more than seven years since the landmark
Institute of Medicine report, Kidney Failure and the Federal
Government. There is much to do to ensure that every person
on the waiting list has the opportunity to obtain the benefits
of organ transplantation. We believe that we are at a crossroads,
and that the time is right to unite our community to enhance
transplantation as we approach the beginning of the new millennium.
The ASTP stands ready to assist in every facet of the process.
Thank you.
