Comment on the CDC guidelines for preventing transmissions of immuno-deficiency virus by transplant of human tissue and organs

To: David Satcher, MD, PhD - Director, CDC
From: Thomas A. Gonwa, MD, FACP - President, ASTP
Date: February 27, 1995

Date posted on the Web: July 25, 1996

Dear Dr. Satcher:

It has come to the attention of the American Society of Transplant Physicians that the recommendations and reports on guidelines for preventing transmissions of immuno-deficiency virus by transplant of human tissue and organs as published in MMWR Vol. 43, Number RR-8 on May 20, 1994, may soon be put into effect by the Department of Transplantation and various federal agencies. The A.S.T.P. would like to comment on these guidelines and state that they cannot support them in their current form. There are two main objections to these recommendations. The first has to do with the potential for decreasing the organs procured in the United States, and the second has to do with cost. The A.S.T.P. believes that these guidelines were formulated in response to a minuscule problem that the organ transplantation community already deals with in a safe and effective manner. In your report you state that there have been four reported cases of HIV transmission by solid organ transplant since the institution of HIV testing of donors. This occurred in one heart recipient, one liver recipient, and two kidney recipients. These were all from one donor. Table I below lists the number of transplantations performed in the United States from the periods 1988 to 1992. The source of these materials are the U.N.O.S. reports which have been published.

TABLE I

YEAR	KIDNEY TRANSPLANT		HEART TRANSPLANT	LIVER TRANSPLANT
	CADAVERIC	LIVING RELATED
1988	7,117	1,329	1,675	1,711
1989	6,983	1,404	1,705	2,198
1990	7,401	1,412	2,107	2,692
1991	7,414	1,778	2,125	2,957
1992	7,300	1,741	2,171	3,067
TOTALS	36,212	7,664	9,783	12,625

GRAND TOTAL: 66,284 TRANSPLANTS

Thus, during this five year period, there were a total of 66,284 recipients. This gives us an infection rate of .006%. I would propose to you that no matter what screening you put in place, you cannot do better than the transplant community has already done in effectively preventing transmission of HIV to prospective organ recipients. Therefore, the A.S.T.P. finds particularly onerous and detrimental the proposals published in the MMWR which require strict questioning of potential donors and donor families as to potential risk factors. We believe that this is already effectively done by the transplant community as evidenced by the incredibly low infection rate seen in donors. Approaching loved ones with these questions could have a chilling effect on organ donation in the United States and we do not believe it will provide any apparent benefit given the low transmission rate. This could be particularly troublesome in the area of pediatric organ donation.

Although your recommendations for post transplantation testing are listed as proposed, they would add a significant cost burden to the transplant programs in this country. Assuming your admitted underestimated cost of $4 per negative test and applying this to the 66,284 transplantations done in this country, it would have cost the health care system an additional $530,000 over the 1988 to 1992 period to test each recipient immediately following transplantation and at a three month interval. Admittedly this cost would be decreased by the number of patients who do not live to three month post transplant, but this would still add a significant cost burden to transplantation in this country.

In summary, the A.S.T.P. cannot support these recommendations in their current form. We believe they are a reaction to a minuscule problem that the community is well aware of and already does a superb job in handling it. The A.S.T.P. and its representatives will be available for further comments if necessary.

Sincerely yours,

THOMAS A. GONWA, M.D., F.A.C. P.
President, A.S.T.P.

TAG/eg

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cc:

The Honorable Donna E. Shalala, Ph.D.
Secretary Health & Human Services
Department of Health & Human Services
Rm 631 F, 200 Independence Avenue SW
Hubert H. Humphrey Building
Washington, D.C. 20201

Ms. Judith B. Braslow, Director
Division of Organ Transplantation
Department of Health & Human Services
Health Resources & Services Administration
Rockville, MD 20857

Mr. Gene Pierce, Executive Director
United Network for Organ Sharing
1100 Boulders Parkway, Suite 500
Richmond, Virginia 23225-87706

Mark Hardy, M.D., President A.S.T.S.
Columbia University
College of Physicians & Surgeons
Presbyterian Hospital
630 West 168th
New York NY 10032

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