ASTP's response to rumored final rule making for the OPTN by DHHS.
November 17, 1997
Date posted on the Web: November 26, 1997

Donna E. Shalala
Secretary
DHHS
615 F. Hubert H. Humphrey Bldg.
200 Independence Avenue, SW
Washington, DC 20201

Dear Madam Secretary:

I write as president of and on behalf of the American Society of Transplant Physicians (ASTP) about the regulations rumored to be forthcoming from your department that address organ procurement and allocation policies. The ASTP is the largest professional transplant society in the US, with broad representation from over 1200 physicians, surgeons, and scientists. The ASTP and its members are involved in the practice of transplantation, research education of peers and education of the American people about tissue and organ transplantation.

Rumors have suggested your department will soon release "final" regulations with features that could be unwise, unsound, contentious and perhaps in opposition to the purposes and the wisdom of the Congress as expressed in the National Organ Transplant Act (NOTA) of 1984. If these rumors prove true, the ASTP fears the release of final regulations without opportunity for public comment, would be unwise and potentially create wide-spread dissension and opposition within the transplant community. There has been little opportunity to publicly comment on the last draft of regulations placed on the table three years ago, let alone an opportunity to scrutinize proposed language rumored to represent wholesale changes in substance and tone of the previous draft, as well as new regulatory schemes not previously disclosed.

Madam Secretary, the ASTP has formally supported the promulgation of final regulations governing the function of the Organ Procurement Transplant Network as established by NOTA and of the relationship of the OPTN with the government in its White Paper review of organ transplantation (which I enclose), however, we feel that these regulations should provide regulatory oversight and enforcement mechanisms to support policies developed by the painstaking practice of evidence-based decision making and consensus building developed by the transplant community. The ASTP strongly supports the concept that decisions concerning organ transplant policy must be based on evidence.

Toward that end our society has sponsored "consensus" conferences and published peer-reviewed literature on allocation, uniform listing criteria, donor and recipient evaluation, and transplant ethics all designed to create a superstructure for decisions that provide maximal equity and utility. Working with sister societies such as the American Society of Transplant Surgeons, The National Institutes of Health, and the Institute of Medicine, we have provided data that has helped the Organ Procurement Transplant Network ( OPTN) develop policy consensus even in the such highly contentious arena as liver organ allocation. It is this process which should be supported, rather than one in which decisions about organ allocation and patient listing are made primarily at the Department removing the basic principle of evidence based decision making and opening these matters to the vagaries of politics, bureaucracy, and lobbying.

The ASTP strongly supports both the oversight function of the Department in transplant matters and the wisdom of the Congress as expressed in NOTA to place the policy decisions about allocation and listing in the private sector with patients, donor family members, scientists, physicians, surgeons, ethicists, histocompatability experts and organ procurement experts all working together to provide policy based on data and balancing equity and utility.

The ASTP commends your efforts, Madam Secretary, and those of your Department to enhance organ retrieval to address the acute and tragic donor shortage driving many of the difficult issues in transplantation. I trust that the transplant community, certainly the ASTP, can work as strong partners with the Department to provide a chance for new or more productive life to many of our countrymen in a fair, equitable manner with full support and confidence of the American people. We must work together, not at cross purposes or in an adversarial manner. The ASTP hopes that draft language of contemplated regulations are released shortly and released for comment so we and others in the transplant community can work with the Department toward establishing policies which maximize the benefits of transplantation in our land.

Thank you for your consideration. The ASTP stands ready to help you in your deliberations on this or any other transplant matter, and we look forward to your response to the above stated concerns.

Sincerely,

J. Harold Helderman, MD
President