Subject: Panel Is Probing Early Abbott AIDS Test Date: Published: 6/28/93 (129 lines) Source: Wall Street Journal. Copyright Dow Jones & Co. Inc. Panel Is Probing Early Abbott AIDS Test --- Role of Red Cross, Test's Reliability Is Questioned ---- By Thomas M. Burton Staff Reporter of The Wall Street Journal In 1985, Abbott Laboratories won approval for a major medical advance: a test to detect the AIDS virus in donated blood. But congressional investigators now believe the early AIDS test missed too many blood donations contaminated with HIV, the virus that causes AIDS. Consequently, dozens of unsuspecting surgical and other patients may have received contaminated blood, say investigators for the House Subcommittee on Oversight and Investigations. The investigators also are critical of the American Red Cross's continued use of the Abbott test for months throughout 1986, despite evidence that other recently introduced tests were more accurate. The issue raises questions about the judgment of companies and organizations in decision-making that affects lives. The Red Cross, for its part, claims it was faced with a dilemma. While it was aware of the problems with the Abbott blood test, it believed any switch to a different test could have created more problems than it solved. Abbott declined to comment for this article, but has previously defended the performance of the blood test. Staff members of the House panel, headed by Rep. John Dingell (D., Mich.) , say the subcommittee expects to publish a report on the AIDS test this fall that is critical of the roles of Abbott and the Red Cross. In addition, several lawsuits have been filed against Abbott, and at least one against the Red Cross, by people who claim they got the virus through blood transfusions. One such case, filed in Cook County, Ill., Circuit Court earlier this year, tells of a boy who got a blood transfusion in 1985 and only last year discovered he has the AIDS virus. The lawsuit, which doesn't name the youth, claims Abbott "did not adequately warn" people they could get AIDS through blood transfusions. Abbott says its test package inserts made clear that not all incipient AIDS virus in blood samples could be detected at the time. Even current tests don't always detect the virus in its early stages, but ones used today, including those of Abbott, are much more precise than the earlier ones. The congressional inquiry turned up internal documents from Abbott and the Red Cross that disclose a fierce internal debate simmered in 1986 at the Red Cross over whether to drop the Abbott blood test. Ultimately, the charity decided against dropping the test. Further, the documents show, staffers at the Food and Drug Administration became increasingly angry during the latter half of 1986 that Abbott hadn't improved its test. By January 1987, Abbott introduced a refined AIDS blood test that detected early cases of virus more effectively than had the old test. The Red Cross immediately adopted that version and today continues to use an Abbott test, as do about threefourths of the nation's blood banks and hospitals. The Dingell subcommittee has been looking into the issue for more than a year; the inquiry followed an article in the Chicago Tribune discussing the early AIDS tests' problem of "false negatives" -- contaminated blood in which virus was undetected. The most powerful data concerning false negatives emerged May 14, 1986, when Alfred J. Saah of the Johns Hopkins School of Hygiene and Public Health and other researchers presented information to the U. S. Public Health Service. The data showed that of 30 blood samples from donors later verified to have the AIDS virus, Abbott's test correctly identified only 13; by contrast, those of two competitors, Genetic Systems Inc. and DuPont Co., each identified 25. Red Cross executives now say they were well aware of such evidence but were concerned that the costs -- both medically and financially -- of trying to switch to a different test were too great. They decided to give Abbott time to fix its existing test. Also, the FDA considered, but rejected, the idea of pulling the Abbott test off the market at the time. Thomas Zuck, then FDA director of blood products, says, "We thought we might screw up more tests by insisting on switching to another system. We thought Abbott would have its test fixed by midfall, though it took a few months longer." Abbott said in a letter to Rep. Dingell, "There was no evidence that any commercially available test was superior to the Abbott test on a consistent basis." "The decision was made to stay with Abbott, not because it was wonderful but because it wasn't all that much worse" than other tests, says James Landmark, an Omaha pathologist who then headed the Red Cross board of blood center directors. Dr. Landmark says the Red Cross was concerned that weeks of training and extensive new equipment would be required for a new test; such a switch might have created more mistakes than it avoided, he said. Within the Red Cross during the summer of 1986, at least one top physician warned the organization's national office that it could face severe dangers by continuing with the Abbott test. On Aug. 6, Peter A. Tomasulo, the doctor then in charge of blood donations to the Red Cross in South Florida, strongly recommended that Abbott's test be dropped. "It is not impossible that, within the next month, we will run across another" blood donor with the virus whose blood tested negative, Dr. Tomasulo wrote in a letter to Dr. Landmark. "We know we have a better chance of detecting such an individual by using the Genetic Systems test," Dr. Tomasulo wrote. Dr. Tomasulo, now the Red Cross chief operating officer for blood services in the group's national office in Washington, says he has since concluded that the Red Cross's decision to stick with Abbott was correct. "The potential for error goes up when you switch," he says. Red Cross officials debated the issue internally throughout the summer and fall of 1986. Minutes of a Nov. 1 meeting of the Red Cross board of blood center directors show that its lawyers advised the group it "could wait no longer before utilizing a test with increased sensitivity" in detecting the virus. But one of the board members responded that "no blood center would be likely to be held negligent for using an FDA approved procedure even if other procedures were claimed to be more sensitive." ("Sensitivity" refers to a test's ability to accurately detect virus when present.) Also throughout 1986, FDA officials became angrier as Abbott failed to produce an improved test. Abbott documents show that the FDA's Dr. Zuck became irate, telling Abbott officials in December, "We told you last April you had a sensitivity problem" and that most Abbott officials "wouldn't listen." At one point, Abbott documents show, he told Abbott that it didn't make good products and was, in effect, "mixing sawdust with the sausage." Dr. Zuck, who has since performed consulting work for Abbott, describes these earlier remarks as hyperbole intended to spur Abbott toward a new test. [This article is made available here by Dow Jones Co. for the personal and non-commercial use of callers to this bbs, in the hope that it will be of some help to those who are suffering from the disease and others who are seeking to help them.]