bioethics: Case Discussion 1

[bioethics@hsphsun2.harvard.edu]

Case 1. Double Standards for an AIDS Drug

Viraret, an antiretroviral drug manufactured in France, was tested in a
South African country in an innovative regiment of short course (1 dose)
treatment of AIDS in pregnant women to prevent mother to child
transmission. The study, conducted under the auspices of the prestigious
Centre pour la Prevencion des Maladies Transmissibles in France, has been
originally designed as a rough comparison of efficacy, not as a pivotal
stand-alone licensing study. As a World Health Organization (WHO) official
put it, Nobody expected Viraret to be so effective. This was meant to be a
quick and dirty first look. However, the data from the trial were so
compelling that the WHO, stating that further trials would be unethical,
endorsed the use of Viravet as a single dose therapy for AIDS in pregnant
women, to prevent mother to child transmission.

The government of an East African country, through its Drug Regulatory
Authority (DRA), took steps to license Viraret for use. However, a
remonitoring of the original data by the French institution showed defects
in compliance with Good Clinical Practice that would not be sufficient for
the French regulatory authority, AFSSAPS, to license the product.
Citing a requirement that drugs proposed for licensing must be licensed in
the country of manufacture, the East African government's refused to
license the product.

WHO reaffirmed its recommendations for Viravet. Subsequently the DRA bowed
to international pressure and licensed the drug.


Questions
     * Is the opinion of the French AFSSAPS relevant to the decision of the
African country's DRA?
     * If so, was there an alternative action that the DRA could have taken?
     * What was the role of WHO in this situation? Was it appropriate?
     * What actions could have been taken by the partners involved to avoid
such a situation?

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*This case contributed by Julie Milstein at the University of Maryland
School of Medicine, Center for Vaccine Development


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