Deaths in vaccine trials trigger French inquiry

Article Abstract:

French AIDS researcher Daniel Zagury has come under sharp attack by a Paris hospital, the French and American press, and, most recently, the French Minister of Health, for his experiments involving a genetically engineered AIDS vaccine that may have killed two AIDS patients. Zagury stated that the vaccine consisted of an inactivated vaccinia virus altered to express AIDS proteins, in an effort to stimulate patients' immune systems against AIDS. According to a dermatologist, Jean-Claude Guillaume, the patients died of vaccinia infection. No mention was made of these deaths by Zagury and his colleagues in their report of the effectiveness of the vaccine an article that was published in The Lancet. Guillaume came to his conclusions based on his examination of skin lesions of two AIDS patients that he could not identify, but later discovered were typical of gangrenous vaccinia (a stage in the development of the disease). Although Zagury denied that this was possible, since the vaccinia virus had been inactivated, Guillaume showed that the virus was present in skin samples that had been taken from the dead patients. This is denied by Zagury in an article in a French medical journal, where he reiterated his conviction that the patients died from herpes virus lesions; the (inactivated) vaccinia virus was only present because the patients had been vaccinated. However, steps have been taken to improve the safety of the vaccine, and Luc Montagnier, a discoverer of the AIDS virus, has expressed his view that the experiments should be interrupted. The genetically engineered virus was supplied by a laboratory of the National Institutes of Health; however, it was Zagury 's task to safely inactivate it. If, in fact, the patients died of vaccinia necrosis, the methods Zagury used were dangerously inadequate. (Consumer Summary produced by Reliance Medical Information, Inc.)

Safety and security measures, Patient outcomes, Mortality, AIDS vaccines, Vaccinia, Zagury, Daniel, Guillaume, Jean-Claude

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Women in clinical trials: an FDA perspective

Article Abstract:

The FDA's 1993 gender guideline indicates that clinical studies on drugs should be performed on patients likely to receive the drug to determine if various groups, such as women and the elderly, respond differently. The guideline's major points are briefly analyzed.

Medical research

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The inclusion of women in clinical trials

Article Abstract:

The FDA's efforts to assure that women are included in clinical drug trials could lead to the implementation of procedures that could force the inclusion or exclusion of particular groups without any scientific justification.

Laws, regulations and rules, Column, Women, Clinical trials, Human experimentation in medicine, Human medical experimentation

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