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Salute to courage.

The once lonely voice of Dr. Edgar G. Engleman sounding the alarm to the dangers of transfusion -caused AIDS

is now heard loud and clear across the land

When it seemed that nothing would awaken either the blood industry or the industry's regulators tO the dangers of transfusion-caused AIDS, Dr.

Ed Engleman at the Stanford University Blood Bank was a lonely voice calling for surrogate testing to screen further for infected blood from those who failed to self-defer. For this, he was vilified in local blood-banking circles. For this, it was said that Stanford's own testing program was merely a commercial ploy to try to lure patients from other Bay Area hospitals.

And for this-as well as for his many other contributions to the war against AIDS-The Saturday Evening Post is proud to present the prestigious Ben Franklin Award to Edgar G. Engleman, M.D., Associate Professor of Pathology and Medicine, Stanford University School of Medicine.

The most recent of these contributions were the recommendations Dr. Engleman submitted to the Presidential Commission on the HIV Epidemic. Excerpts from his address follow:

"On July 1, 1983, Stanford University Blood Bank became the first in the nation to screen donated blood with a test designed to reduce transfusion transmission of AIDS. We used specialized reagents and equipment already on hand in our research laboratory to detect a white-blood-cell abnormality which nearly always occurred in AIDS patients and was also present in many high-risk individuals who felt perfectly well. In contrast to our actions, most other blood banks did not initiate any blood-donor screening tests until 1985, and in addition, many blood bankers criticized us for doing so, arguing that there was no proof that AIDS could be transmitted by blood transfusion and that the test we were using was experimental and too costly.

"We felt that AIDS could not be dealt with in the same way as other infectious diseases. Unlike most other infections, AIDS has an extraordinarily long latent phase (the time between exposure and clinical manifestation) and is nearly always fatal. Therefore, while acknowledging that our test (called the T-cell test) would not necessarily detect 100 percent of AIDS carriers and would identify some individuals who were not carriers at all, we nonetheless felt that the benefits of preventing AIDScontaminated blood from entering the blood supply outweighed the fact that some normal blood was unavoidably discarded and that each unit of blood cost $6 more. In our view, the blood-banking community failed to recognize that we could not afford to wait until the causative agent was discovered or until the perfect test was developed. In 1983 and '84, we presented our findings to the academic community, to blood bankers, and to the FDA, and repeatedly spoke out in public on the need to implement available screening tests, imperfect though they might be, to reduce the risk of transmitting AIDS by transfusion. In the summer of 1983 we submitted an abstract on the subject at the Annual National Meeting of the American Association of Blood Banks (AABB). We cited the need for blood testing to reduce the risk of transmitting AIDS by transfusion, described how the T-cell test was performed, and reported on this use in our blood bank. Our abstract was rejected for presentation at that meeting. It was particularly distressing to discover later that the subject of transfusion-associated AIDS was not even on the meeting's program. While we certainly don't believe that there was a conscious conspiracy, there seemed to be great reluctance among blood bankers to acknowledge the problem.

"In the summer of 1983, follow-up interviews revealed that several people we excluded had in fact donated. Later that year we learned that a donor whose blood our test rejected had been hospitalized with AIDS some eight months later. After introduction of the specific AIDS antibody test in 1985, we retrospectively tested frozen sera from blood donors whose T-cell tests had been abnormal and found that true HIV-positive donors were 500-fold more frequent in the group rejected by our test than in the donors acceptable by the test.

"Although we chose to use a test that would have been difficult for many blood banks to adopt quickly, other, more feasible tests were also available. The test for antibody to the core component of hepatitis B is a relatively inexpensive test which utilized equipment already on hand at most blood banks. Using this test would have markedly reduced the rate of HIV transmission via transfusion without seriously jeopardizing the blood supply.

"Why did the blood-banking leadership, national organizations, and government agencies fail to recommend any testing of donor blood before 1985? The contributing factors basically boil down to an extraordinary resistance to change and criticism, a failure to accept imperfect solutions to urgent problems, and a lack of insightful leadership within the blood-banking community. One example antedates the AIDS epidemic altogether. In 1980, Drs. Ann Yeager and Carl Grumet developed a simple blood test for the presence of antibodies to cytomegalovirus (CMV). They demonstrated that by using only CMV seronegative blood, the devastating clinical consequences of transfusion-transmitted CMV infection in premature infants could be completely avoided. The cost of the test was no more than two dollars and the results were clear-cut. Did the blood banking organizations adopt the test to protect susceptible patient groups? The AABB and the Red Cross did not endorse CMV testing for five more years, and many blood bankers called such testing impractical or inexact, a theme we heard again with AIDS surrogate screening. Even now, the AABB Standards for Blood Banks and Transfusion Services call for blood banks to perform CMV testing only where transfusion-associated CMV disease is a problem. Thus, it should come as no surprise that indirect blood tests for AIDS were rejected. Until very recently the industry has required that the utility of any candidate test must be proven over and over and over again before it can even be considered for mandatory use.

"Another problem relates to autologous blood (the patient's own blood) for patients anticipating surgery. Blood banks may have inadvertently discouraged its use by, for example, limiting the locations and hours available for autologous donations. Autologous and patientdirected donations now constitute 18 percent of our blood supply!

"The AIDS tragedy appears to have already improved the responsiveness of blood-banking organizations. For example, blood tests similar to those rejected by blood bankers for prevention of AIDS in 1983 to '85 are now used by virtually all blood banks to try to prevent transmission of non-A, nonB hepatitis. Most blood banks now offer both patient-directed and autologous blood-transfusion programs.

"HTLV-I, recently shown to be transmissible via transfusion, appears to be the underlying cause of a fatal form of leukemia as well as a severe neurologic disorder. The current hesitance of blood banks to employ available HTLV-I antibody screening assays may represent the most recent example of delayed use of available technology. Although there is a need for a reliable confirmatory test, widespread application of the current HTLV-I antibody assay could reduce the transmission of the HTLV-I virus to transfusion recipients. Therefore, although there may not yet be sufficient information to warrant formal licensure by the FDA, we nonetheless believe that the tests should be applied for blood-donor screening without further delay, and we hope that the Presidential Commission will make this recommendation."

[Editor's note: This was done.] "Many blood bankers and bloodbanking organizations continue to argue publicly and privately that more could not have been done to prevent transfusion-associated AIDS prior to the availability of the specific AIDS antibody test. This suggests that they simply don't realize that the system failed or that it has flaws. If so, then the recent adoption of stringent new blood-testing procedures by blood banks may possibly represent a response to public pressure rather than a result of self-examination. When the current public outcry abates, can we be confident that the industry will respond any differently to future, unforeseen problems?

"Not only has there been no objective, outside investigation of AIDS in the blood supply, but to our knowledge there hasn't even been an internal evaluation by the large blood-banking organizations. An independent group of scientists and physicians with expertise in all relevant areas should analyze the response of blood banks and the government to the issue, not for the purpose of assessing blame, but in order to identify problems and their underlying causes and to make recommendations on how such problems can be avoided in the future. The Presidential AIDS Commission should recommend the formation of a task force at the earliest possible date, under the auspices of an impartial body such as the National Academy of Sciences.

"While we do not want to prejudge the conclusions that such a task force might draw, we would like to suggest a number of specific steps which we hope would be endorsed by the Commission. Many physicians and nurses are relatively poorly trained with respect to the indications for transfusion, and they are even less knowledgeable about the potential complications. Blood isa lifesaving but nonetheless potentially dangerous agent which should be treated no differently than other dangerous intravenous medicines, and there is no excuse for our professional schools not to better educate future physicians and nurses on the proper use of transfusions."
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Title Annotation:includes excerpts from Dr. Engleman's address to the President's Commission on the HIV Epidemic; Dr. Edgar G. Engleman awarded Saturday Evening Post's Ben Franklin Award for alerting the world to the danger of transfusion-caused AIDS
Publication:Saturday Evening Post
Date:Sep 1, 1988
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