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CDC's revisions would reduce number of organs available for transplant--Mitch Henry, MD, ASTS president.

"I'm writing to keep you apprised of the status of the Centers for Disease Control's (CDC) efforts to revise the 1994 PublicHealth Service (PHS) Guideline for-Preventing Transmission of HIV through Transplantation of Human Tissue and Organs. The intent was to modify the guideline to more accurately reflect today's clinical practice--but by ASTS standards, that intent has failed.

When the CDC undertook this initiative they formed an external Review Committee to provide expert input for the document and invited key organizations to appoint representatives to contribute to this effort. The transplant community was supportive of the goal of developing new guidelines and ASTS, AST, AOPO and NATCO each had an official representative on the Review Committee that provided his/her time and expertise toward this effort. Additionally, there were several ASTS and AST members/experts who were asked to participate in the process as individuals, rather than representing the Society directly.

When the draft guideline was circulated to the Review Committee as a precursor to release for public comment), it created considerable concern and many of the experts requested their name be removed from the acknowledgement section of the guideline. Here's why:

* The document makes strong recommendations that do not accurately reflect the input from the transplant community's representatives;

* The document is not fully supported by existing data;

* The document includes practice specifications which are overly prescriptive and represent unprecedented direction of care, and:

* Recommendations regarding living donor testing were added--again without expert input which contradict the conclusions of the recent Optimal Testing of the Live Donor to Prevent Transmission of Infectious Disease Consensus Conference..

ASTS Opts Out

In the end, ASTS, AST, AOPO, and NATCO all withdrew their names from the document and have sent a letter to HHS Assistant Secretary Howard Koh, MD, outlining our concerns with both the process and the document. We are concerned the proposed guideline will reduce the number of available organs for transplant--a concern you and I work hard every day to mitigate. Additionally, the letter pointed out that such an outcome is inconsistent with HHA' broader policy objectives and with the needs of our patients.

What's Next?

Despite our concerns, the CDC seems determined to put forward the guideline in its current state and we anticipate it will soon list in the Federal Register for public comment. Once released, there will be a sixty day window to submit a response. ASTS is already working on its response and we plan to share it with you as early as possible in the comment window. You can also influence this process by working with your respective transplant teams to review the guideline and submit your own comments. In the meantime, I am hopeful that the unified stance of ASTS, AST, AOPO and NATCO will resonate with HHS and we will be afforded meaningful contributions to the final guideline.

I thank you in advance for your support. It is important to present a unified front on an issue that is critical to our practice. Standing firm on issues that require strong advocacy efforts will allow us to best serve our members and our patients. In closing, I encourage you to contact me with your ideas or feedback.
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Publication:Transplant News
Date:Sep 1, 2011
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