U.S. Report Criticizes Treatment of French AIDS Test Volunteers

Human volunteers were not adequately protected during studies of an experimental AIDS vaccine, the National Institutes of Health says in a report critical of a French researcher and his U.S. collaborator, according to knowledgeable sources.

The probe, conducted by NIH’s Office for Protection from Research Risks, said that Dr. Daniel Zagury of the University of Paris violated regulations. It specifically cited his failure to notify American authorities of the deaths of three French volunteers who received an experimental AIDS vaccine.

The report also criticized Dr. Robert C. Gallo of the National Cancer Institute, the American credited with co-discovering the human immunodeficiency virus that causes AIDS. Zagury had listed Gallo as a co-author on published reports of the vaccine experiment, but NIH sources said that Gallo’s role was minimal.

NIH “must be held accountable as an institution for the actions of its agents,” the report said, according to NIH sources.

The experimental vaccine used a preparation made of vaccinia--a virus that causes cowpox in cows--into which a piece of HIV was inserted. Vaccinia, which is the same substance used to provide protection against smallpox, is usually harmless in humans. But it can be dangerous to individuals with impaired immune systems, such as those with AIDS. Although Zagury has said that the vaccinia was inactivated before it was used, three of the subjects who received the vaccine apparently died of vaccinia disease. Nineteen people participated in the study.