South Africa to tighten control on drug trials after five deaths

Pat Sidley , Johannesburg

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.