Medical research on vulnerable populations in the developing world must respect their rights and wellbeing to remain ethical. But a recent trial in Tanzania, funded by the US Food and Drug Administration (FDA), has been accused of breaking the rules in the interests of US biodefence.
In this article, Martin Enserink tells how plague expert Thomas Butler, hearing of 63 plague victims in Tanzania, conducted trials of the antibiotic gentamicin there. The study sought to plug a gap in US biodefence by widening the choice of antibiotics to stockpile in case bioterrorists used the bacterium in the United States. Then it emerged that Butler had allegedly failed to obtain informed consent from the patients.
Butler now faces jail on a number of counts. The FDA has also come under fire for buying the results when the trial was never fully approved. What is worse, some now suggest that the research itself is fundamentally flawed, making the whole exercise a hugely expensive mistake.
Reference: Science 302, 2056 (2003)