The U.S. Food and Drug Administration's rationale for supporting the development and approval of BiDil for heart failure specifically in black patients was based on under-powered, post hoc subgroup analyses of two relatively old trials , which were further complicated by substantial covariate imbalances between racial groups. Indeed, the only statistically significant difference observed between black and white patients was found without any adjustment for potential confounders in samples that were unlikely to have been adequately randomized. Meanwhile, because the accepted (...) baseline therapy for heart failure has substantially improved since these trials took place, their results cannot be combined with data from the more recent trial amongst black patients alone. There is therefore little scientific evidence to support the approval of BiDil only for use in black patients, and the FDA's rationale fails to consider the ethical consequences of recognizing racial categories as valid markers of innate biological difference, and permitting the development of group-specific therapies that are subject to commercial incentives rather than scientific evidence or therapeutic imperatives. This paper reviews the limitations in the scientific evidence used to support the approval of BiDil only for use in black patients; calls for further analysis of the V-HeFT I and II data which might clarify whether responses to H-I vary by race; and evaluates the consequences of commercial incentives to develop racialized medicines. We recommend that the FDA revise the procedures they use to examine applications for race-based therapies to ensure that these are based on robust scientific claims and do not undermine the aims of the 1992 Revitalization Act. (shrink)

This question as to whether machines can, or could, be made to think, has become familiar in recent years since the renewed outburst of interest that has taken place in the development of Cybernetics. The notion of servo–mechanisms and the like has a history in remote antiquity but the form of its fundamental question has recently taken on a new and especially acute significance.

I would like to make some further clarifying remarks about the nature of learning machines, or finite automata as they are more generally known these days. It is clear from much that has recently been written on this subject that there are still many misunderstandings about their capacity and significance.

Professor A. D. Ritchie's remarks cannot go without some reply, since otherwise they would only have the effect of increasing the already considerable confusion on the subject of Cybernetics.

I Would like to draw attention to the basic defect in the argument used by Mr J. R. Lucas.Mr Lucas there states that Gödel's theorem shows that any consistent formal system strong enough to produce arithmetic fails to prove, within its own structure, theorems that we, as humans, can nevertheless see to be true. From this he argues that ‘minds’ can do more than machines, since machines are essentially formal systems of this same type, and subject to the limitation implied (...) by Godel's theorem. (shrink)