Fall 1998 Volume 3, Number 3		Federal committee recommends near-tripling of targeted hepatitis C lookback program (Washington) Bowing to the will of a powerful congressional committee, a federal advisory committee has recommended a massive expansion of the federal hepatitis C targeted lookback program. Under the new recommendation, adopted on November 24, 1998 by the Advisory Committee on Blood Safety and Availability (ACBSA), the lookback program would nearly triple in size, from about 300,000 to 800,000 persons. The earlier plan, adopted by DHHS Secretary Donna Shalala in January 1998, called on blood banks and transfusion services to notify about 300,000 persons who received blood transfusions from donors who later tested positive for hepatitis C on second-generation screening and supplemental tests (i.e., in 1992 and beyond). For full details on the hepatitis C targeted lookback program, see the Hepatitis Control Report, Fall 1997 issue. The new recommendation would expand the existing program by including recipients of blood from donors who later tested repeatedly positive on first generation anti-HCV screening tests (EIA-1). Blood banks used these tests from 1990 until second-generation tests became available in mid-1992. The public health and blood banking communities have largely viewed targeted lookback as costly and ineffective, and for many years have favored general programs aimed at educating physicians and at-risk groups about the need for HCV testing (called "general lookback"). FDA and CDC considered and rejected targeted lookback programs several times from 1987 to 1995. But, in 1996, the program gained favor with a powerful congressional subcommittee chairman, Rep. Christopher Shays (R-CT). Shays' subcommittee, the Subcommittee on Human Resources of the House Government Reform and Oversight Committee, held hearings on the subject in 1995 and issued a report urging DHHS to do targeted lookback. In response, ACBSA recommended targeted lookback to Shalala in August 1997. At its meeting on November 24, 1998, ACBSA members debated the merits of adding recipients of blood from donors identified with first generation tests. A hepatitis C expert from CDC, Dr. Miriam J. Alter, pointed out that many of the first generation tests were never confirmed with supplemental tests. Thus, many notifications - as many as 68% - may be based on false positive EIA-1 tests. "We feel that it's just as important for people not to receive false notifications as it is for people to receive notifications based on a high level of certainty," she said. Additionally, Alter noted that notification of this group would be highly inefficient, since, based on estimates from post-transfusion survival data, 90% of them are no longer living. Judging by response data from similar lookback programs, of the 10% who are still alive, only a fraction -- perhaps as low as 5%-20% -- can be located and will respond to the letter. And, of these, only a proportion will be previously unaware of their infection and will actually proceed to screening and treatment. But after an emotional and sometimes bitter debate, a majority of ACBSA members was swayed by a "right-to-know" argument based in individual ethics. According to this view, many recipients of potentially contaminated blood do not even know that they were transfused, and they have a right to the information. Without an individual letter, thousands of recipients would have no opportunity to seek treatment for HCV infection. The Committee's final vote was 10 to 5, with 2 members abstaining. ACBSA acted under great pressure from Shays and his subcommittee, which issued a report in mid-October 1998 urging DHHS to expand the targeted lookback program (see article in Hepatitis Control Report, Summer 1998 issue). The same report criticized FDA for delaying implementation of the program. The cost of the currently-planned lookback program has been estimated at about $250 million. The expansion would raise the cost substantially. Implementation will also take proportionately longer to complete, extending into several years. Soon after the vote to expand the targeted lookback program, some ACBSA members complained that the Committee had not sufficiently taken into account the problems of implementing such a massive expansion of the program. Accordingly, the Committee voted to delay implementation of the expansion until the Public Health Service has had an opportunity to review it and to present options for its implementation and evaluation. The Committee will take this up at a meeting in Washington on January 28, 1999.