Monday miscellany

  • "Have India’s poor become human guinea pigs?" -- a disturbing BBC report by Sue Lloyd-Roberts on lack of informed consent in drug trials in India. Powerful and necessary reporting, especially if the allegations are borne out, but one quibble: reporting on the absolute number of deaths of people in drug trials is not very informative; it's really more a measure of how many people are enrolled in trials (and what type of trials). Lots of people die during clinical trials -- and in fact for trial where mortality is at outcome they must die in the trial if we are ever to measure mortality effects! If you're enrolling people with heart disease or cancer or other serious diseases in a clinical trial, you might have a lot of deaths in both the treatment and control arms -- and the total number would still be large even if the trials are going well and showing huge benefits from new drugs, so just reporting that there were 438 deaths in clinical trials in 2011 is not very informative! The questions are whether a) people are dying at a higher rate than they would have without the trial, and b) regardless of deaths, whether they consented to be in the trial in the first place. The article seems to be mostly (and rightly) questioning the latter, but uses the death counts in an potentially alarmist way.
  • "The sea has neither sense nor pity: the earliest known cases of AIDS in the pre-AIDS era." This is a fascinating read from the blog Body Horrors, recounting the story of a Norwegian sailor who acquired HIV in the 1960s, and subsequently died from AIDS (along with his wife and daughter) before knew what AIDS was. One thing the piece doesn't point out is that while this is the earliest known case of AIDS, the earliest known case of HIV is from an (anonymous) blood sample from the Congo in 1959 -- background on that case in Nature here.
  • The British Medical Journal will require all clinical trials to share their data, starting in January. Hopefully other journals will follow their lead. This is big -- more soon.