“There have been gazillions of conferences and reports from national commissions and councils,” said Johns Hopkins bioethicist Ruth Faden in 2001. “In the developing world, there’s been a tremendous ratcheting up of interest in this question . . . of how to take account of politics and economic questions in research ethics.” While the poles of the debate quickly emerged, with Lurie and Angell on one side and PhRMA spokespeople and FDA regulators on the other, most of the mainstream of the research community remained undecided. “We are struggling,” said Faden. “We are reaching more consensus on conditions under which it is OK” to dole out substandard care in clinical trials, she said, but “increasing lack of consensus on whether it is alright in other circumstances.”1 While the medical and bioethics press continued to appraise the intricate ethical complexities of the issue, a small battalion of researchers, led by FDA regulators and their advisers, attempted to seize the fluidity of the moment to shape ethical guidelines to their advantage.
