CAPE TOWN - The South African Paediatric Association (Sapa) added
its voice on Friday to the chorus of concern regarding the possible
banning of anti-retroviral Aids drug Nevirapine, saying it was safe.
Earlier in the day, the Treatment Action Campaign said it was
consulting lawyers on the matter.
Sapa, in a statement, noted "with grave concern" the decision of
the Medicines Control Council of South Africa (MCC) to reject the
results of a Ugandan study.
The study focused on the use of Nevirapine in the reduction of
risk of mother-to-child transmission of HIV.
"The executive committee of Sapa believes the efficacy and safety
of Nevirapine usage, as part of a strategy for the prevention of
transmission of HIV from mother to child, has been adequately
established beyond reasonable doubt," Sapa said.
Sapa said the rollout of the prevention of mother-to-child
transmission programmes (PMTCT) in South Africa -- including the
provision of Nevirapine -- had already saved "many hundreds or
perhaps thousands of infant lives".
Sapa warned that any disruption of these programmes would have
"We believe that failure to continue to administer Nevirapine at
this time would constitute a dereliction of the ethical duties of
individual health care professionals as well as an
unconstitutional abdication of responsibilities of our health
"We appeal to the MCC to immediately repeal their decision that
is out-of-step with the extensive reviews and statements of
authoritative bodies such as the US National Institutes of
Health, the US Federal Drug Administration and the World Health
"We urge our members in the field to follow their conscience by
utilising the accepted practice of providing Nevirapine as part
of the PMTCT programme. In doing so they will dramatically and
significantly lower the risk of transmission of HIV from mother
to child and thus prevent most cases of childhood Aids," Sapa
The MCC said on Thursday it might withdraw permission for the use
of Nevirapine on the grounds that it was unhappy with the Ugandan
trials on which registration was based.
It gave manufacturers Boehringer-Ingelheim 90 days to provide
information proving the drug's safety and effectiveness.
But the TAC said in a statement that all publicly available data
on short-course nevirapine used for MTCT prevention indicated it
was safe and effective.
"If the MCC has information to the contrary, it must make this
available because of the public interest in this issue. In the
meanwhile the TAC will seek legal opinion from its lawyers on how
to proceed on this matter."
TAC, which 16 months ago won a High Court order forcing the
government to implement a rollout of ARVs to pregnant mothers,
said the MCC had played "political games" with the registration
of nevirapine since 1999.
"The MCC has not provided the public with any new scientific
information to support its inexplicable position," the TAC said.
"The recent work of the MCC to register generic ARVs including
Nevirapine is being undermined by its fork-tongued approach."
Nevirapine was not the only drug that can be used to reduce
mother-to-child HIV transmission. AZT was more effective, but it
was also slightly more expensive and complex.