Statement of the American Society
of Transplantation before the Honorable Donna Shalala Secretary
of the Department of Health and Human Services on the Amended
Rule Regarding the Governance of the Organ Procurement and
Transplant Network
December 10, 1999
Madam Secretary, the American Society
of Transplantation appreciates the opportunity to once again
meet with you and the Department to discuss how we can continue
to work together to improve our nation's transplant system.
We commend you for your ongoing dedication and leadership on
these critical issues. The AST is the largest professional
transplant organization in the United States and represents
over 1,200 physicians, surgeons and scientists. The AST and
its broad-based membership is dedicated to the development
and delivery of patient care, basic and clinical research,
and patient, professional, and public education in the fields
of organ and tissue donation and transplantation.
On many occasions throughout this
debate, the Society has made recommendations to the Department
that we felt would strengthen and improve the Administration's
rule addressing organ allocation and the governance of the
Organ Procurement and Transplant Network (OPTN). In testimony
before Congress and the Administration, the AST has supported
three basic principles. These principles are: 1) the need to
increase organ donation; 2) the need for equitable access to
transplantation; and 3) the need for the leadership role of
the OPTN in the formulation of organ transplantation policies.
In reviewing the Department's amended
rule, of October 18, 1999, the AST was pleased that DHHS provided
additional clarity on some key issues and agrees with the Department
that:
- There should not be a single
national list for transplant recipients;
- Transplant policies must be specifically
tailored to different organs;
- Criteria should be developed
to remove patients from a transplant list if transplantation
is no longer a medically appropriate option;
- An advisory committee on organ
transplantation should be formed to provide appropriate guidance
and oversight on critical transplant issues; and
- New allocation policies should
be based on medically-appropriate broader sharing of organs.
Although AST is
pleased that the recently amended rule provided clarity on
some of the more
contentious issues surrounding the current debate, AST remains
concerned about one of the primary principles that the Society
has supported since the Department first issued the original
rule .........."medical decision-making." The transplant
community should create through consensus and scientific research,
the policies which provide for organ transplantation in this
nation. The Federal Government should provide appropriate oversight
and authority to such policies so that they may be effectively
implemented.
While the Department has agreed
to form an advisory committee on organ transplantation, AST's
recent requests for further information regarding the role
and authority of this new body have not been adequately addressed.
AST is supportive of the independent advisory committee concept,
and has recommended and supported the establishment of an independent
scientific review board, as proposed in the report of the Institutes
of Medicine. However, the Administration has given no assurances
that its proposed advisory committee on organ transplantation
will have any oversight role or have adequate input into the
process to assure that the system is effective, equitable and
grounded in the best available medical science. As such, the
AST remains concerned regarding the issue of medical decision-making.
The AST remains interested in identifying what the role of
the advisory committee would be and encourages the Department
to provide this committee with the appropriate level of authority
and independence to assure that decisions are based on medical
science and protect the overall welfare of patients.
Madam Secretary, as you know, the
problems we face in the allocation of organs and tissues for
transplantation, a precious and scarce resource, are complex,
and the issues are still evolving from both a medical and a
policy perspective. We must work together as the transplant
community, broadly defined, to ensure that all proposed changes
in policy and solutions to current problems represent positive
steps for patients and their families. As such, the AST looks
forward to continuing to work with the Administration and Congress
to successfully resolve this debate and hopefully further strengthen
our country's transplant system.
Thank you.
