Hunt for an AIDs market key to resolving transfusion fears.
While appearances suggest a retarn to normal in the blood banking community following the peak of openly expressed public concern last summer over transfusion-related AIDS cases, some uneasiness still simmers. And that anxiety likely will remain until either we unravel the mysterious etiology of acquired immune deficiency syngrome or we develop a test to detect its presence in blood.
At this writing, close to a dozne Government units were working diligently toward both ends. On the test side, for instnce, the Food and Drug Administration had scheduled a mid-December conference of Federal and privatesector scientists to share and explore the latest research accumulated in the hunt for an AIDS marker. "There's a substantial amount of activity, and we need to bring together what we know so far,' said Dr. Dennis Donohue, director of the FDA's Division of Blood and Blood Products.
Across town, National Heart, Lung, and Blood Institute officials were poring over 31 responses to its recent call for research grant applications. This spring they will award nearly $2 million targeted for support of new or ongoing studies to find a specific AIDS-identifier test. "We'll probably fund or contribute to 10 or 15 projects, some under way, some start-up,' said Dr. George Nemo of NHLBI's Division of Blood Resources. "We know that indirect tests, alone or in combinations, are now being used. But reliability hasn't been demonstrated. What we hope will emerge from our effort is a direct test for the disease in the carrier state.
"It's conceivable that we could have that ideal test within a year,' Dr. Nemo added. "But we are seeking Congressional authorization for a three- to five-year effort.'
Absent a cause or a cure for AIDS, the sooner the success in developing the desired detection test, the better for the blood banking community, which then can put to rest the nagging directed-donor issue. Facts, figures, and logic had all but sent the matter into hybernation late last year. But close observers know that the potential exists--particularly this year--for awakening and recharging debate.
The threat lingers because the disease apparently has a two-year incubation period. Meanwhile, the aggressive national campaign to exclude, on a voluntary basis, blood donations by the four highrisk populations (homosexuals or bisexuals with multiple partners, intravenous drug abusers, hemophiliacs, and Haitians) is only a year old.
"So I wouldn't be surprised if more transfusion-linked AIDS appears in the population over the next 12 to 18 months,' said Dr. Albert Grindon, medical director of the American Red Cross in Atlanta. "If AIDS can indeed be transmitted through transfusions, then such a result is reasonable to expect.'
And if the number of transfusion-associated cases should spurt, the phones at blood banks could begin ringing as they did last May following an ABC 20/20 program on the subject, said Dr. Grindon, who also serves on the American Association of Blood Banks' transfusion-transmitted diseases committee.
"That show triggered public concern nationally about blood donations,' he said. But since late summer "calls requesting directed donations have dropped considerably here and, as I understand, around the country. I'm not sure patient worries have abated, however. Partly, I think, the national educational effort has paid off. But, at least here in Atlanta, I think the physicians have understood and agreed with our policy against directed donations and simply told patients that they aren't possible.
"If there are more transfusion-related cases, I'm not sure things will stay quiet.'
Should anxiety rise again, blood banks will once more feel the pressure to respond to the public's demand. If the answer is an increase in directed-donor programs, Dr. Grindon and many other blood bankers believe the tail will be wagging the dog, with dangerous consequences.
"Even if the transfusion-associated numbers go up, it's extremely unlikely they'd reach a point where the risk of AIDS transmission warrants a change in the blood banking system. As long as the system remains completely voluntary, we won't encounter difficulties,' Dr. Grindon asserted.
At this writing, the Centers for Disease Control has recorded 2,800 AIDS cases. Of these, 37 victims (30 adults and 7 children) were known not to be in one of the high-risk groups but had received a transfusion within the last five years. "Virtually all these patients had received blood from multiple donors, anywhere from 2 to 50 of them,' said Dr. James Curran of the CDC AIDS activity team.
CDC, he said, has completed its investigations on about 12 of these patients, and in each case a high-risk donor was found. Investigations are considered complete only when every donor is found, and for most of the remaining cases two-thirds of the donors tracked down were not in the high-risk groups.
Although these numbers are up from the mid-1983 figures (1,600 total cases, with 14 adults and one child possibly transfusion-related), they do not alter the basic facts involving patient risk. With more than 10 million transfusions a year in the U.S., the odds of transfusion-associated AIDS is about one per one million blood recipients. By comparison, the risk of a fatal incidence of hepatitis through transfusion is much greater, according to blood bank authorities.
That one per million figure became the cornerstone of last year's still-operative joint policy statement by the American Red Cross, the AABB, and the Council of Community Blood Centers against directed-donor programs.
Those odds, it said, along with the facts relating to safety, do not justify the risks that directed donations pose to the blood supply system.
First, the policy noted, the concept that family, friends, and other selected groups are "sure to provide safer blood is unrealistic. These same individuals are and have been the nation's volunteer blood donors who have in the past given freely for all patients rather than individual patients . . .. In addition, a system of directed donations may create intense pressure on family members and friends who may therefore be untruthful about their ability to meet donor requirements.'
Moreover, the administrative and operational complexity of such a program could significantly increase clerical errors, jeopardizing any assumed increase in transfusion safety, the statement cautioned.
"Finally, there is a real concern that donors may refrain from routine blood donations while awaiting requests to provide directed donations and, thereby, could disrupt rupt the blood supply to the point that routine and even emergency needs for transfusions may go unmet,' it said.
A College of American Pathologists' statement recently supported that position. "Originally, there was some feeling that in certain situations directed-donor programs to meet AIDS-related concerns are justifiable,' said Dr. Roger Smith, chairman of the CAP's AIDS task force. "But a consensus has developed that the progrems, risks, and safety questions in directed-donor programs outweigh the nearly nonexistent danger of AIDS transmitted through transfusion.'
Directed-donor programs aren't necessarily contentious about such positions. "So long as there are no statistics to demonstrate safety, you can argue both sides,' said Elizabeth Draper, blood bank operations manager at Philadelphia's Thomas Jefferson University Hospital. "We can't says our directed-donor program is safer, and we tell our patients that.'
That facility began its program, which is optional, shortly after phone calls--30 to 40 a day for a while--flooded in following the 20/20 telecast. At the time, the hospital, which for years had maintained its own donor center in addition to using the regional blood bank, was conducting an autologous donation program as well as a directed-donor program for renal transplants.
"We found it philosophically difficult to turn down the requests when we had an operational donor center and two existing programs with similar requirements,' she explained. "So we expanded. As a service organization, we wanted to, and we probably would have come in for criticism if we hadn't.'
At its peak, the program accommodated about two dozen patients and 40 donors in a month. Patients must arrange for their own donors. "They aren't always willing or able to do so,' she said. She acknowledges that without the preexisting facilities and programs "the decision to go ahead would have been much more difficult.'
Further, she points out, "If and when there's definitive test for AIDS in blood, we'll dissolve the program. There won't be a need.'
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|Publication:||Medical Laboratory Observer|
|Date:||Jan 1, 1984|
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