By Pat Sidley

BMJ 15 April 2000

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 treatments for breast cancer (12 February, p 398; 18 March, p 732).

The drug trial in question was known as the FTC 302 trial and was being conducted in adults. According to Dr Helen Rees, who chairs the regulatory authority, the Medicines Control Council, the aim of the trial was to document the safety and efficacy of different combinations of antiretroviral drugs, including a new unregistered drug called emtricitabine.

It also included the new drug nevirapine, manufactured by Boehringer Ingelheim and being tested in South Africa for its use in the prevention of vertical transmission of HIV. Some 16 sites were being used around the country.

The applicant was a US pharmaceutical company, Triangle, which was told to stop recruiting patients for the trial and was then told to stop the trial.

It was initially believed that the health minister, Dr Manto Tshabalala-Msimang, had stopped all drug trials relating to HIV and AIDS, particularly those using nevirapine and to prevent all vertical transmission. There remains considerable confusion in the industry.

The Medicines Control Council has been reviewing its control of drug trials, as have various ethics committees. The ethics committee that was supposed to have had been involved in the FTC 302 trial has emerged from the problem with its reputation seriously damaged.

The number of drug trials in South Africa have risen rapidly recently, and there seems to be widespread consensus that the system is in urgent need of an overhaul. Dr Rees of the Medicines Control Council said that the council, the health department, and various ethics committees had been involved in restructuring the way clinical trials are dealt with.

The council has had a ministerially appointed clinical trials committee to help advise it on these issues. Despite this, questions remain over the methods used in the wake of the Bezwoda affair and this latest development.