Unanswered questions and ethical issues concerning US biodefence research

Unanswered questions and ethical issues associated with US biodefence medical research over the past five decades are discussed. Objective scientific standards are essential for making policy decisions that can stand the test of time. For decades, scholars have reported that the human anthrax vaccine field trials conducted in the 1950s by Brachman and his colleagues were single-blind rather than double-blind. Nevertheless, in March 2005, Dr Philip S Brachman reported in a letter to the US Food and Drug Administration that his study had been double-blind. It is here argued that, rather, the field trial of a human anthrax vaccine should continue to be deemed as single-blind unless more detailed information is provided to explain exactly how the investigators were kept unaware of which subjects were in the treatment and control groups. Moreover, a number of other questions about the details of this critically important study have remained unanswered and are discussed. More recently, similar concerns have arisen with respect to more contemporary biodefence research, especially with reference to the Federal Bureau of Investigation's allegations that Dr Bruce Ivins, a US government biodefence researcher, was responsible for the anthrax letter attacks of fall 2001. The medical ethics and related issues involved with continuing to base national biodefence and public health policy on unclear, if not contradictory, research are discussed.