This 1997 editorial from The Lancet is one of three articles that kicked off the current debate about appropriate standards of care in clinical trials. Commenting on the other two articles (published the week before in the New England Journal of Medicine) it concludes that placebo-controlled trials of antiretroviral drugs used to prevent mother-to-child transmission of HIV violated a fundamental ethical principle of medical practice, namely that doctors should do no harm. The reason given is that women were harmed because they received no effective treatment to prevent transmission of HIV to their children.

The article dismisses the argument put forward by those justifying the trials: that if they had not been conducted none of the women would have received an effective treatment. Instead, it focuses on "the fact remains that some women were given a treatment that the physicians in charge knew was not the best possible intervention". The editorial goes on to explain the need for the ‘ethics industry’ that comments on such matters to be "rooted in clinical practice and not in armchair moral philosophy".

[This article is reproduced with permission from The Lancet.]


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