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WASHINGTON
REPRESENTATIVE:

Bill Applegate
Director of
Government Relations

Armstrong Teasdale LLP
1747 Pennsylvania Avenue, NW
Suite 300
Washington, DC 20006-4604
P: 202- 454-2864
F: 202-
393-0363
wapplegate@armstrongteasdale.com

American Society
of Transplantation
15000 Commerce Pkwy.
Mt. Laurel, NJ 08054
P: 856-439-9986
F: 856-439-9982
ast@ahint.com


 

 

 

 

 

 

 

 

  PUBLIC POLICY LIBRARY
   

Response to the ASTP comment on the U.S. Centers for Disease Control (CDC) guidelines for preventing transmission of immuno-deficiency virus by transplant of human tissue and organs

To: Thomas A. Gonwa, MD, FACP - President, ASTP
From: David Satcher, MD, PhD - Director, CDC
Date: June 13, 1995

Date posted on the Web: July 25, 1996

Dear Dr. Gonwa:

Thank you for your letter concerning the Centers for Disease Control and Prevention (CDC) guidelines published in the Morbidity and Mortality Weekly Report (MMWR), Volume 43, Number RR-8, entitled "'Guidelines for Preventing Transmission of Human Immunodeficiency Virus Through Transplantation of Human Tissue and Organs.'' I apologize for the delay in responding to your letter.

Regarding your concern about the questioning of potential donors and donor families, the issues surrounding the determination of whether a donor meets behavior/history exclusionary criteria are quite personal and could be viewed as intrusive by grieving families considering cadaveric donation. The CDC guidelines address this by acknowledging the time constraints and that family members and close friends may not always be able to provide an accurate social history. However, the exclusion of HIV-infected but seronegative donors relies on an accurate social and sexual history and is a critically important step.

According to the United Network for Organ Sharing (UNOS) Policy 4.l.l., Organ Procurement Organizations (OPOs) shall "obtain a history on each potential donor in an attempt to determine whether the potential donor is in a high risk group as defined by CDC." To our knowledge, OPOs comply with this policy by reviewing the potential donor's medical record, including the cause of death; performing a bedside physical examination; and interviewing the family about the donor's medical and social history. We are confident that OPOs staff use discretion in discussing these sensitive issues, and we are not aware of any evidence suggesting that the family consent conference discourages a family from donating. According to the Division of Organ Transplantation, Health Resources and Services Administration (HRSA), the number of donations has not decreased since the CDC guidelines were published.

CDC does not agree with your statement that post-transplant recipient testing imposes a "significant cost burden" on transplant programs. Since 1991, UNOS has received information on 18 cases in which a transplant recipient tested positive for HIV after a transplant. In each case, the donor has been ruled out as the source of infection. This "look-back" procedure reinforces the safety of our country's organ transplantation system and provides opportunities for early intervention for recipients. According to HRSA, about 18,000 transplants are performed annually; we do not believe that the annual cost of testing is a significant burden for the transplant community, compared with the public health benefits of being able to identify recipients with HIV infection.

I appreciate your sharing the concerns of the American Society of Transplant Physicians with CDC.

Sincerely,

David Satcher, M.D., Ph.D.
Director

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