E-drug: South Africa News (cont'd)
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I have just seen this news item in the British Medical Journal in their
electronic version. I wonder if someone from South Africa could
comment and let us all know what is going on.
BMJ No 7137 Volume 316, News Saturday 4 April 1998
South Africa's drug regulatory body attacked
South Africa's drug regulatory authority looks likely to be disbanded
after a series of skirmishes between the council, its chairman, and the
minister of health. The move follows a scathing report on the Medicines
Control Council commissioned by the minister of health, Dr Nkosazana
Dlamini-Zuma.
The team that wrote the report, headed by a British expert in drug
regulatory issues, Professor Graham Dukes, strongly criticised the
Medicines Control Council for what it saw as a total breakdown in
communication between the council and all its stakeholders. It also
criticised the council for allowing a potential conflict of interests to
develop between pharmaceutical manufacturers and the council and for
a lack of effective monitoring of all stages of clinical trials.
The review team, which was appointed in January, concluded that the
best solution was to close the Medicines Control Council and start
again. However, questions have been asked about the legitimacy of the
team, which was widely seen as working on behalf of the minister of
health for political ends. The team largely contacted representatives of
the pharmaceutical industry for its research, and took less than three
months to carry out its review of the council and propose changes.
The Medicines Control Council and its generally well respected
chairman, Peter Folb, have clashed head on over the past year with Dr
Zuma over her desire to see a potentially dangerous treatment for AIDS
(Virodene) on the market in South Africa (14 March, p 800). The
council has consistently refused to allow the drug on to the market. Dr
Zuma then changed the law allowing her to overrule decisions taken by
the council.
Dr Zuma has accepted the broad recommendations of the review
committee. She says the Medicines Control Council will stay in place
until a new body is formed.
Pat Sidley,
Johannesburg
Thank you
Richard Laing M.B. Ch.B. M.Sc. M.D. Tel 1-617-414-1444
Associate Professor Fax 1-617-638-4476
Department of International Health
Boston University School of Public Health
715 Albany Street, T4W
Boston MA 02118 USA
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