As AIDS test nears market, urgent questions arise.
All indications at press time pointed to the commercial availability by spring of an AIDS virus antibody detection kit. Tempering that good news, however, was the recognition that imperfections in the testing process mean that the kits are a hoped-for beginning, not an end.
Anticipating both the arrival of the long-awaited test and the ethical questions tied to it, the American Blood Commission and the New York-based Hastings Center will sponsor a conference late this month in Arlington, Va. The meeting's goal is to prepare the laboratory and blood banking community for the detection kit's imminent introduction, and to develop guidelines for using the test.
The guidelines, said ABC's Nancy Holland, will deal with "the rights and responsibilities of donors, recipients, and blood service operators" and seek "to balance what is ethically sound with what is operationally feasible."
Regarding the test itself, ABC and most organizations following AIDS developments had every reason to expect its commercial availability in February or March. Although most of the details on progress toward the test were shrouded in competitive secrecy, work was apparently moving forward without major hitches.
Five firms (Abbott Laboratories, Du Pont/Biotech, Electro-Nucleonics, Litton Bionetics, and Travenol-Genentech) won licenses in June to develop and produce the kits based on a National Cancer Institute prototype.
Public Health Service researchers, headed by NCI's Dr. Robert Gallo, had isolated in April a retrovirus, HTLV-III, as the likely cause of AIDS. Also they had learned to grow the virus and had secured patents, under PHS, for serological detection of the virus and the method for continuous HTLV-III production (see Washington Report, MLO, August 1984).
"The companies now are generating clinical trial data on the two key areas--sensitivity and specificity," said Dr. John Petricciani, chief of the Food and Drug Administration's Blood Products Division. "Each company, at its own pace, is going ahead with studies of samples from blood and plasma donors, from individuals in high-risk populations and from patients, such as cancer victims, where special test problems occur."
The effort, he said, was in sync with the timetable projected six months ago. "We should see a test on the market in early 1985 unless something goes terribly wrong," he said.
Perhaps more important, Dr. Petricciani expects the tests that reach the market first will be followed in rapid order by superior products. "I think the evolution in improvements will be as dramatic as those we've seen in the tests for hepatitis over the last decade--with one significant difference," he said. "The evolution of the following generations will be compressed into a year or 18 months' time. I believe that's absolutely inevitable, given our improved technology, the social and medical concerns about this disease, and the competitive factor among the HTLV-III manufacturers."
The race for the test's approval, of course, takes place against a disturbing flow of new statistics and findings about AIDS. Centers for Disease Control figures in early December reveal that:
* In 1984, 3,821 new cases were reported, 74 per cent more than a year ago.
* Total cases: 6,993. Of these, 3,342 (48 per cent) have died.
* Of those diagnosed with AIDS prior to 1983, 73 per cent have died.
* Of all cases, 81 are related to blood transfusions given to adults or adolescents. Another 12 are linked to transfusions in children.
* Overall, CDC reports 46 cases of hemophilia-related AIDS in adults or adolescents, and another four in children.
Moreover, CDC heightened national concern and awareness late last year by announcing that preliminary studies indicate as many as 300,000 people may have been exposed to AIDS, which has about a three-year incubation period. That may explain why the incidence of AIDS has not leveled off as expected, the Federal researchers noted.
The routine use of blood products apparently has not added fuel to the fire. The dangers related to transfusions are still minimal in the extreme, or about one chance in one million transfusions of transmitting the disease.
"Personally, I don't think there has been any significant change in the concern about the probability of transmission through blood products," noted Dr. Petricciani. "IF there has been a change in the last year it's just that there no longer is any question about whether the event occurs. Last year there were doubts. Now it's accepted, I believe, that blood transfusion cases can happen."
Still, the infrequency with which they occur has raised one of the major questions confronting an industry anticipating a marketed kit: Is there a need to make testing of each blood donation mandatory?
Some had argued against the requirement on grounds that, given the low odds, the added costs were not warranted and blood service operators should be free to use the kits selectively. As CDC figures have mounted, however, opposition to universal testing has receded.
In fact, the American Association of Blood Banks, which had monitored the debate for months, was to release a position statement late last month recommending that members utilize the test for all donations.
AABB, like other blood groups, believes that "the major issue after test utilization is the problem of what to tell donors who test positive," said Gilbert Clark, AABB executive director. "Since the test-in-development identifies the HTLV-III antibody, the donor could be in one of several states of health. We hope CDC provides guidelines on what steps to take after a positive test."
The American Red Cross is acutely aware of the same problem, and currently is contemplating undertaking a related research project. "The trouble is that no one has any information on the implications for an apparently healthy donor who is found to be reactive for anti-HTLV-III," said Dr. Roger Dodd, ARC's transmissible diseases and immunology department chief.
"We should know, for instance, how likely that person is to contract AIDS, what can be done for that person, and so on." Dodd said the ARC is exploring the possibility of a project that would track donors. "Right now we're determining whether we can do it and how we should do it."
Of course, the AIDS test has potential use outside the donor scenario for identifying disease victims and in research to improve testing or answer questions such as those ARC poses. But many scientists fear that the homosexual community, the major at-risk population, will not participate in or cooperate with studies, primarily for reasons of confidentiality.
Dr. Ronald Bayer, an associate for policy studies at the Hastings Center and chairman of the forthcoming ABC/Hastings conference, says his discussions with leaders of the gay community convince him that a boycott of research participation is possible. Consequently, he and two colleagues recently published a recommended set of "Guidelines for Confidentiality in Research on AIDS" in the Center's November/December issue of IRB: A Review of Human Subjects Research. Among the 24 recommendations:
* Researchers should resist subpoenas that seek compulsory disclosure of information that would identify the subject.
* Every AIDS research protocol should undergo full institutional review board scrutiny, whether or not the research is Federally funded.
* In jurisdictions where AIDS is a legally reportable disease, although individuals do not have the right to refuse to participate in such surveillance, they should be notified that such reporting will occur.
Copies of the guidelines are available for $5 from the Hastings Center, 360 Broadway, Hastings-on-Hudson, N.Y. 10706.
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|Title Annotation:||acquired immune deficiency syndrome|
|Publication:||Medical Laboratory Observer|
|Date:||Jan 1, 1985|
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