South Africa to tighten control on drug trials after five deathsBMJ 2000; 320 doi: https://doi.org/10.1136/bmj.320.7241.1028 (Published 15 April 2000) Cite this as: BMJ 2000;320:1028
- Pat Sidley
South Africa's HIV/AIDS drug trials industry has been thrown into confusion after the government had to intervene and stop a trial in which five patients died. About 11% of patients in the trial showed signs of severe liver toxicity, and serious allegations were levelled against the trial organisers that women involved in one site of the trial had not given fully informed consent.
This problem has arisen amid serious soul searching among medicines'regulators, research ethics committees, drug companies, and doctors after research procedures had to be questioned when Werner Bezwoda falsified research results into …