Mr. Chairman and Members of the
Subcommittee, thank you for the opportunity to present testimony
on behalf of the American Society of Transplant Physicians
(ASTP).
I am John F. Neylan, M.D., Associate
Professor of Medicine and Medical Director of the Renal Transplantation
Program, at Emory University Hospital and I am President -Elect
of the American Society of Transplant Physicians (ASTP). The
ASTP, which has no governmental support, was established in
1982. Our membership, now over 1,000 members strong, is comprised
of physicians and scientists actively engaged in the research
and practice of transplantation medicine and immunobiology.
Given that our membership spans the disciplines of cardiology,
hepatology, nephrology, pulmonology, infectious disease, and
histocompatability, and that 25 % of our members are surgeons
with an expertise in related surgical specialties of solid
organ transplantation, the ASTP represents the largest and
broadest number of professionals in the field of transplantation
in the United States.
A principle goal of the ASTP is
to serve as a forum for the exchange of scientific information
related to transplantation and immunology and to promote and
encourage research. One of the strategies for obtaining this
goal is our annual scientific meeting. At the 1997 ASTP Annual
Meeting in Chicago last May, we had over 1,000 abstracts submitted
highlighting cutting edge science in transplantation medicine
and immunobiology.
Today, my testimony will focus on
Fiscal Year 1999 appropriations for the National Institutes
of Health (NIH), particularly the National Institute for Allergy
and Infectious Diseases (NIAID), National Institute for Diabetes,
Digestive, and Kidney Diseases (NIDDK), National Heart, Lung,
and Blood Institute (NHLBI). I will highlight those areas of
research that need to receive additional emphasis and funding
in fiscal year 1999.
During the next hour, four new names
will join those 56,793 individuals in this country waiting
for a solid organ transplant. And by the time I get home to
Atlanta this evening, 10 individuals will have died because
the wait for a transplant was just too long.
But, Mr. Chairman with increased
funding for research there is hope.
Over the last 20 years, transplantation
of solid organs has moved from experimental to accepted therapy,
with nearly _____ performed in 1997 alone. The success of this
procedure has improved greatly over the last few years with
almost all solid organ recipients enjoying an 83 - 97% survival
rate at one year. Much of this success can be attributed to
research in immunosuppression that has been funded by previous
NIH appropriations. However, this success has brought with
it new challenges.
More and more individuals
are agreeing to be placed on waiting lists for an organ transplant.
As I
mentioned before, 56,793 individuals are currently waiting
for transplants, an increase of 255% in the last ten years.
It is unfortunate and absolutely unnecessary for those in need
of a transplant to go without the "Gift of Life." This
happens because the supply of available donors is far less
than the demand. Each year, the ASTP identifies the shortage
of available donors as the number one problem in the field
of transplantation.
In December 1997 the Administration
launched a national organ and tissue donation initiative to
encourage more families to discuss and understand there loved
ones' wishes in regard to donation. This may help in reducing
family refusal, which is the number one cause of loss of potential
donors today. Therefore, the ASTP urges this Subcommittee to
provide the Department of Transplantation located in the Health
Resources and Services Administration with additional funds
for FY 1999. This funding will help to insure the success of
the Administration's initiative and any other programs conduct
by the Department of Transplantation that enhance donor awareness
and improve the public trust in the process.
Research is central to all that
occurs in the transplantation process. The ASTP believes that
we are on the threshold of many important scientific breakthroughs
in areas of transplantation research, such as rejection immunosuppression
tolerance and xenografts. Because of this, the ASTP strongly
urges this Subcommittee to continue its leadership in the area
of biomedical research and provide a 15% increase in funding
for the NIH for FY 1999. The ASTP supports this level of increase
for the NIAID, the NIDDK, and the NHLBI, as well. By providing
this increased level of funding, this Subcommittee will achieve
the ultimate goal of doubling the NIH budget in 5 years. A
concept supported by the ASTP and many of those societies who
are members of the Ad hoc Coalition for Biomedical Research.
With this level of increase, this Subcommittee and the Congress,
as a whole, will have the personal satisfaction of knowing
that they were responsible for expanding the general transplantation
research authority at the NIH, as a whole.
With this expanded authority, clinical
and basic transplantation funding at the NIH must be increased.
In particular, we recommend that Congress and the NIH designate
the following as high priority initiatives at the NIAID, the
NIDDK, and the NHLBI.
The National Institute for
Allergy and Infectious Diseases (NIAID)
1) Basic and clinical immunology,
stressing an understanding of immunologic mechanisms of tolerance
and autoimmunity, evaluation of chronic transplant rejection,
and immunosuppression in transplant patients.
2) Basic immunology stressing the
response to xenotransplants and methods to overcome the response.
3) Further structures on identification
and treatment of infectious disease risks associated with xenotransplantation.
The National Institute for
Diabetes, Digestive, and Kidney Disease (NIDDK)
1) Continuation of the liver transplant
database.
2) Studies to improve the survival
of renal transplants, including improved mechanisms of donor
and recipient matching.
3) Clinical trials to compare the
outcome of combined kidney-pancreas transplant to kidney alone
for diabetic patients. Prioritize increased funding for pancreatic
islet cell transplantation.
Great progress has been made in
the field of pancreas transplantation and now simultaneous
kidney/pancreas transplant offers greater survival at five
years than kidney alone, and the majority of patients no longer
need insulin. However, most insurance companies do not cover
this combined transplant because definitive prospective studies
have not been conducted. The NIDDK needs to sponsor a trial
to document the superior benefit of combined kidney/pancreas
transplant to convince third party payers and Medicare to cover
this procedure, and further fund research to assess the comparative
benefit of whole organ (pancreas) versus islet cell transplantation.
National Heart, Lung, and Blood
Institute (NHLBI)
1) Clinical trials in immunosuppression
in heart transplantation.
2) Research on chronic rejection,
applying promising new technology such as intravascular ultrasound.
One new clinical advance is the
development of an intravascular ultrasound imaging technique
that allows measurement and detection of thickening of the
vessel wall of the transplanted organ and follows these changes
over time. This is currently being performed in heart transplant
recipients, but the test is not reimbursed. This is the perfect
opportunity to have NHLBI partner with industry to conduct
a trial of new therapies to retard or prevent the development
of this disease.
3) Establish the creation of databases
for each stage heart disease to understand the disease and
plan future needs.
Heart failure is the number one
admitting volume diagnosis in the Medicare system, the longest
DRG, and it has the highest readmission rate. There are an
estimated one million people with this diagnosis which has
as much or more of an impact on the health care budget as any
other disease. In addition, the increasing average age of the
U.S. population indicates that this disease will only increase.
We talk quite a
bit in the transplantation community about how receiving a
transplant can be the "Gift
of Life." You can't put a price tag in human terms of
such a gift. Yes, a transplant procedure and follow-up care
is expensive. But, relative to the lost productivity, the impact
on quality of life, and the cost of living with end stage heart
or renal disease, transplantation is cost effective. Also,
it may be the only hope not just for improved survival, but
for a full and healthy life for many individuals and their
families. So, I end my remarks here today, by repeating ASTP's
request that this Subcommittee and the Congress approve a 15%
increase for the NIH for FY 1999. Thus allowing the high priorities
initiatives outlined above to be funded and commence.
Thank you.
