As AIDS test nears market, urgent questions arise Essay

The national commitment to conquering AIDS continues with guardedoptimism. All indications at press time pointed to the commercialavailability by spring of an AIDS virus antibody detection kit.Tempering that good news, however, was the recognition thatimperfections in the testing process mean that the kits are a hoped-forbeginning, not an end. Anticipating both the arrival of the long-awaited test and theethical questions tied to it, the American Blood Commission and the NewYork-based Hastings Center will sponsor a conference late this month inArlington, Va. The meeting’s goal is to prepare the laboratory andblood banking community for the detection kit’s imminentintroduction, 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 bloodservice operators” and seek “to balance what is ethicallysound with what is operationally feasible.

” Regarding the test itself, ABC and most organizations followingAIDS developments had every reason to expect its commercial availabilityin February or March. Although most of the details on progress towardthe test were shrouded in competitive secrecy, work was apparentlymoving forward without major hitches. Five firms (Abbott Laboratories, Du Pont/Biotech,Electro-Nucleonics, Litton Bionetics, and Travenol-Genentech) wonlicenses in June to develop and produce the kits based on a NationalCancer Institute prototype. Public Health Service researchers, headed by NCI’s Dr. RobertGallo, had isolated in April a retrovirus, HTLV-III, as the likely causeof AIDS. Also they had learned to grow the virus and had securedpatents, under PHS, for serological detection of the virus and themethod for continuous HTLV-III production (see Washington Report, MLO,August 1984). “The companies now are generating clinical trial data on thetwo key areas–sensitivity and specificity,” said Dr.

John Petricciani, chief of the Food and Drug Administration’s BloodProducts Division. “Each company, at its own pace, is going aheadwith studies of samples from blood and plasma donors, from individualsin 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 sixmonths ago. “We should see a test on the market in early 1985unless something goes terribly wrong,” he said. Perhaps more important, Dr. Petricciani expects the tests thatreach the market first will be followed in rapid order by superiorproducts.

“I think the evolution in improvements will be asdramatic as those we’ve seen in the tests for hepatitis over thelast decade–with one significant difference,” he said. “Theevolution of the following generations will be compressed into a year or18 months’ time. I believe that’s absolutely inevitable,given our improved technology, the social and medical concerns aboutthis disease, and the competitive factor among the HTLV-IIImanufacturers.” The race for the test’s approval, of course, takes placeagainst 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 ayear 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 havedied.

* Of all cases, 81 are related to blood transfusions given toadults or adolescents. Another 12 are linked to transfusions inchildren. * Overall, CDC reports 46 cases of hemophilia-related AIDS inadults or adolescents, and another four in children. Moreover, CDC heightened national concern and awareness late lastyear by announcing that preliminary studies indicate as many as 300,000people may have been exposed to AIDS, which has about a three-yearincubation period. That may explain why the incidence of AIDS has notleveled off as expected, the Federal researchers noted. The routine use of blood products apparently has not added fuel tothe fire.

The dangers related to transfusions are still minimal in theextreme, or about one chance in one million transfusions of transmittingthe disease. “Personally, I don’t think there has been any significantchange in the concern about the probability of transmission throughblood products,” noted Dr. Petricciani. “IF there has been achange in the last year it’s just that there no longer is anyquestion about whether the event occurs. Last year there were doubts.Now it’s accepted, I believe, that blood transfusion cases canhappen.

” Still, the infrequency with which they occur has raised one of themajor questions confronting an industry anticipating a marketed kit: Isthere a need to make testing of each blood donation mandatory? Some had argued against the requirement on grounds that, given thelow odds, the added costs were not warranted and blood service operatorsshould be free to use the kits selectively. As CDC figures havemounted, however, opposition to universal testing has receded. In fact, the American Association of Blood Banks, which hadmonitored the debate for months, was to release a position statementlate last month recommending that members utilize the test for alldonations. AABB, like other blood groups, believes that “the major issueafter test utilization is the problem of what to tell donors who testpositive,” 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 CDCprovides guidelines on what steps to take after a positive test.” The American Red Cross is acutely aware of the same problem, andcurrently is contemplating undertaking a related research project.”The trouble is that no one has any information on the implicationsfor an apparently healthy donor who is found to be reactive foranti-HTLV-III,” said Dr. Roger Dodd, ARC’s transmissible diseases and immunology department chief.

“We should know, for instance, how likely that person is tocontract AIDS, what can be done for that person, and so on.” Doddsaid the ARC is exploring the possibility of a project that would trackdonors. “Right now we’re determining whether we can do it andhow we should do it.” Of course, the AIDS test has potential use outside the donorscenario for identifying disease victims and in research to improvetesting or answer questions such as those ARC poses. But manyscientists fear that the homosexual community, the major at-riskpopulation, will not participate in or cooperate with studies, primarilyfor reasons of confidentiality.

Dr. Ronald Bayer, an associate for policy studies at the HastingsCenter and chairman of the forthcoming ABC/Hastings conference, says hisdiscussions with leaders of the gay community convince him that aboycott of research participation is possible. Consequently, he and twocolleagues recently published a recommended set of “Guidelines forConfidentiality in Research on AIDS” in the Center’sNovember/December issue of IRB: A Review of Human Subjects Research.Among the 24 recommendations: * Researchers should resist subpoenas that seek compulsorydisclosure of information that would identify the subject.

* Every AIDS research protocol should undergo full institutionalreview 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 insuch surveillance, they should be notified that such reporting willoccur. Copies of the guidelines are available for $5 from the HastingsCenter, 360 Broadway, Hastings-on-Hudson, N.Y.



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