Company Sues Over Publication of Unfavorable AIDS Vaccine Trial Results
A California-based biotechnology company is seeking more than $7 million in damages from the scientist and university that submitted study results showing that the company's drug was ineffective in preventing AIDS to the Journal of the American Medical Association (AP/Baltimore Sun, 11/1). In 1996, the Immune Response Corporation initiated "one of the largest HIV studies ever conducted" to test whether the drug Remune could serve as an AIDS vaccine for people already infected with HIV (Hilts, New York Times, 11/1). The study included 2,527 HIV-positive people who were randomly assigned to take Remune and an adjuvant, "a standard vaccine-boosting chemical," or the adjuvant alone (Brown, Washington Post, 11/1). In May 1999, the study was prematurely stopped by an independent monitoring committee after researchers concluded from preliminary results that the "vaccine was not working." The lead authors of the study, Dr. James Kahn of the University of California-San Francisco and Dr. Stephen Lagakos of the Harvard School of Public Health, prepared the study results for publication even though Immune Response objected to some of the content of their report (New York Times, 11/1). The company is arguing that the final publication of the study should have included a "subset of data" on 250 patients that showed reduced levels of viral load. Kahn, however, refused to include the data, saying that the company was "dredging" the data for good results (Maugh, Los Angeles Times, 11/1). Remune was first developed by Jonas Salk, the inventor of the first polio vaccine. The vaccine is made by using killed HIV that is "stripped of its outer coat" (Collins, Philadelphia Inquirer, 11/1). These "inactivated copies" of the virus, known as HIV-1 Immunogen, have had the proteins necessary for viral replication removed. In the study, which appears in today's JAMA, people who received HIV-1 Immunogen had a higher average number of CD4 cells, but at a level that "may not be ... clinically significant" (Reuters Health/Excite News, 10/31). After the first two years of the study, 53 people taking Remune and 53 taking the placebo had "worsened or died," leaving researchers to conclude that the drug was not effective. They determined that the vaccine "showed no benefit, as measured by survival or health improvement rates" (Washington Post, 11/1). The Controversy Kahn's decision to write the report despite the objections of Immune Response, and JAMA's decision to publish it, has ignited debate. First, the commencement of the study in 1996 coincided with the introduction of protease inhibitors, which decreased the normal death rate among HIV-positive people from 6% to 1%. This fact, according to Immune Response President Dennis Carlo, meant that the size of the study population would have to be increased at least six times to measure accurately the effect of Remune. Dr. Robert Schooley of the University of Colorado Health Sciences Center said, "The study was doomed from the start because the whole method of treating the disease changed during the trial. [The monitoring board] recognized the futility of continuing." Kahn disagreed, saying that the 106 people whose condition worsened provided an adequate indicator of the ineffectiveness of Remune (Los Angeles Times, 11/1). Second, because of its desire that Kahn not publish the paper, Immune Response withheld as much as 10% of the data from the researcher (New York Times, 11/1). However, both sides concur "that did not change any conclusions about the product's efficacy." Immune Response, according to Kahn, did not provide all of the names of the study investigators at the 77 medical centers that participated in the study, which led Kahn to not share the manuscript with any other researchers, a move which is "virtually unprecedented" (Los Angeles Times, 11/1). One of these investigators, Dr. John Turner of Philadelphia's Graduate Hospital, said he was "outraged" by the publication of the study, according to the Inquirer. "It's an erroneous presentation of a huge amount of results from a very important study," he said (Philadelphia Inquirer, 11/1). In a similar vein, Dr. Ronald Moss, Immune Response's vice president of medical and scientific affairs, accused JAMA of "tabloid journalism" for publishing the study (AP/Baltimore Sun, 11/1). According to the New York Times, Dr. Drummond Rennie, JAMA's deputy editor, conceded it was "very unusual" to publish a study without all the data, but said that the journal "went ahead because the study was so large and significant and because the journal wanted to support the freedom of investigators to publish their data without the interfering bias of the sponsor" (New York Times, 11/1). An arbitrator will now decide if UCSF violated its contractual agreements with Immune Response by not having the final paper peer reviewed, as the company claims (Philadelphia Inquirer, 11/1). In the arbitration complaint filed last month, Immune Response claims that the "dissemination of the negative findings caused it financial harm," the Sun reports (AP/Baltimore Sun, 11/1).This is part of the KHN Morning Briefing, a summary of health policy coverage from major news organizations. Sign up for an email subscription.