JOHANNESBURG (Reuters) - South Africa's top medical body met on
Friday to decide whether to approve a key anti-AIDS drug in
what experts believe is a litmus test for the government's
commitment to fight the deadly disease.
The regulatory Medicines Control Council was to rule on
granting a licence to allow German firm Boehringer-Ingelheim to
distribute its nevirapine (viramune) drug as a preventive drug
in mother-to-child (MTC) transmission and its wider use in the
public health system for HIV-positive adults and minors.
Approval for the drug is seen as a gauge of the government's
commitment to fight AIDS, which already infects one in 10, or
4.2 million, South Africans and threatens to kill up to seven
million within a decade.
An estimated 5,000 HIV-positive babies are born every month in
South Africa, which is at the epicentre of the AIDS epidemic
that affects some 35 million people globally.
President Thabo Mbeki has been lashed by scientific and
diplomatic criticism after voicing doubts over the link between
HIV and AIDS and denying the use of drugs such as AZT in the
public health system on cost and safety grounds.
"As far as we are aware it's on the Council's agenda today.
They have the latest report by the World Health Organisation in
front of them," a Boehringer-Ingelheim spokesman in
Johannesburg told Reuters.
The WHO concluded this month that the safety and effectiveness
of antiretroviral regimes that prevent MTC transmission of HIV
- including nevirapine - meant there was no justification for
restricting any of the regimens to pilot projects which are
also under way in South Africa.
WHO had earlier expressed concerns over development of a
nivirapine-resistant virus in women using treatment, a concern
that was shared by the South African government which has
denied a licence to nevirapine for MTC and public health system
use for more than a year.
Babies are infected with the virus by their mothers either in
the womb, during birth or through breast feeding. Up to 600,000
babies are born each year with the virus. Ninety percent of
these cases are in the developing world.
South Africa To Approve Aids Drug
Separately, it was reported that the country's Health Ministry
- which has said antiretroviral drugs have a highly limited
role in public health policy - was set to give a rare green
light to another drug in the fight against AIDS.
The Business Day newspaper said the ministry and Pfizer would
sign a deal on World AIDS Day, December 1, to provide the
antifungal treatment drug fluconazole free of charge to poor
AIDS patients suffering from cryptococcal meningitis. "We are
pleased with the way the negotiations have gone between the
department and Pfizer," Health Minister Manto
Tshabalala-Msimang said. "The spirit during the negotiations
has been frank and characterised by cooperation."
AIDS activist groups, who protested outside the Council
meeting, have imported cheaper generic versions of fluconazole
from Thailand to protest against government's refusal to
license the drug.