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More Information on Ethics and Clinical Trials

Letter in JAMA on Problems with HIV-1 Vaccine Study

This letter, by Health Research Group Deputy Director Peter Lurie, M.D., MPH, and Director Sidney Wolfe, M.D., appeared in the Journal of the American Medical Association (JAMA) on May 2, 2001.

To the Editor: We would like to point out that the IRC, which sponsored the study by Dr Kahn and colleagues,[1] has been accused of previous attempts to improperly influence the presentation of scientific data on its HIV-1 Immunogen.

In June 1994, authors from the company published the results of a placebo-controlled trial of this agent. The authors concluded that the vaccine "may ... stabilize the percent of CD4 cell decline."[2]

However, in a January 9, 1995, Warning Letter to the IRC, the Food and Drug Administration (FDA) noted that 2 subjects had been excluded from the published article even though the article stated that the analysis included all treated patients. Furthermore, the statistical analysis that was conducted was not the one described in the study protocol. The FDA concluded: "As a result of these deviations from protocol, a significant result was published in the article" (J. C. Simmons, Office of Compliance, Center for Biologics Evaluation and Research, FDA, written communication [Warning Letter] to Dennis J. Carlo, IRC, January 9, 1995).

The warning letter also accused the IRC of representing the vaccine prior to approval in a promotional context; failing to follow informed consent regulations; including in its trials at least 31 subjects who did not meet entrance criteria; changing data retroactively for several reports; modifying adverse experience information; and changing data categories retrospectively, after unblinding.

Despite these multiple irregularities, which the FDA described in its warning letter as violations of the Food, Drug, and Cosmetic Act and other FDA regulations, 2 FDA advisory committees meeting together voted on January 26, 1995, to approve wider testing of the HIV-1 Immunogen.[3] This subsequent trial resulted in the study reported by Kahn et al.

This story continues to unfold, as the vaccine is currently being advocated as monotherapy for HIV-infected patients in Thailand.[4]

Peter Lurie, M.D., M.P.H.
Sidney M. Wolfe, M.D.
Public Citizen's Health Research Group
Washington, DC



[1] Kahn JO, Cherng DW, Mayer K, Murray H, Lagakos S, for the 806 Investigator Team. Evaluation of HIV-1 immunogen, an immunologic modifier, administered to patients infected with HIV having 300 to 549 x 106/L CD4 cell counts: a randomized controlled trial. JAMA. 2000;284:2193-2202.

[2] Trauger RJ, Ferre F, Daigle AE, et al. Effect of immunization with inactivated gp 120-depleted human immunodeficiency virus type 1 (HIV-1) immunogen on HIV-1 immunity, viral DNA, and percentage of CD4 cells. J Infect Dis. 1994;169:1256-1264.

[3] Neergard L. FDA panel recommends widespread testing of therapeutic AIDS vaccine [wire service release]. Associated Press. January 27, 1995.

[4] Thaitawat N, Bhatiasevi A. Drive to register drug disturbs health experts. Bangkok Post. April 10, 2000.

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