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WHO says nevirapine is safe
22/03/2002 17:54 - (SA)
Pretoria - The Treatment Action Campaign (TAC) had no reason to believe that the Medicines Control Council (MCC) would withdraw the registration of the anti-retroviral drug nevirapine, the Pretoria High Court heard on Friday.
Gilbert Marcus, SC, for the TAC, referred to a letter by the MCC to Health Minister Manto Tshabalala-Msimang alerting her to serious concerns which the United States' Food and Drug Agency (FDA) had expressed about a nevirapine test conducted by a US institution in Uganda.
According to the letter, dated Wednesday, questions had been
raised about the reporting and documentation of the study on the
use of Viramune (of which nevirapine is the active ingredient) for the prevention of mother-to-child-transmission of HIV.
The MCC said it would review nevirapine in the light of those
developments.
Marcus said the TAC hoped that when considering the matter of
nevirapine's registration, the MCC would also take account of the
view of the World Health Organisation (WHO) regarding its safety
and efficacy.
The WHO was of the opinion that there was no need to confine the use of nevirapine to the 18 pilot sites in the country, he said.
Botha gave okay
The TAC also hoped the MCC would take note of research done on the matter in a project at Khayelitsha in the Cape Peninsula,
Marcus said.
In December last year, Judge Chris Botha granted an application by the TAC, paediatrician Haroon Saloojee of the organisation Save Our Babies, and the Children's Rights Centre, for an order forcing the government to make nevirapine available to HIV-positive pregnant women at all state facilities with the capacity to do so and where it was medically indicated.
Earlier this month, Botha issued a certificate allowing the
government to ask the Constitutional Court to hear its appeal
against the order. At the same time, Botha granted an application
by the TAC for an execution order.
The latter order meant that the government had to provide
nevirapine outside the pilot sites pending the outcome of its
possible Constitutional Court appeal.
The Health Minister and seven health MECs (of all provinces
except the Western Cape and KwaZulu-Natal, where nevirapine
programmes have already been expanded beyond the pilot sites) on
Friday asked Botha for a certificate to allow them to approach the Constitutional Court for permission to hear their appeal against the execution order.
The TAC brought an urgent counter-application to prevent that
from happening.
Should not be allowed outside pilot sites
Marumo Moerane, SC, for the government, argued that the new
information about the Uganda study was an indication that the
administration of nevirapine should not be allowed outside the
pilot sites.
The health authorities must await the outcome of the MCC's
investigations into the matter and in the meantime it had to adopt a cautious approach, he said.
Botha asked him whether the government would stop administering nevirapine at the pilot sites on the basis of the latest developments.
Moerane answered: "We will certainly do so if the investigations that the MCC conducts in the light of the information of the FDA reveals that there was fraud in the reporting and documentation of that Ugandan study or that information submitted to the MCC on closer analysis and scrutiny was incorrect or, if on the basis of what the MCC will have known by then, they have withdrawn the registration.
"The probabilities are there that the pilot sites will be closed down."
At least at the pilot sites there were monitoring and
evaluation, Moerane said.
"The new circumstances demand caution and limitation to exposure to the drug."
Could be de-registered
Marcus said that the possibility had existed all along that
nevirapine, like any other drug, could be de-registered.
That argument was no basis to allow the government to further
contest the execution order, he said.
If there were doubts about the safety and efficacy of
nevirapine, they applied to all patients using it - at the pilot
sites and in the public and private sector, Marcus said.
Botha is expected to deliver his judgment on Monday.
The Constitutional Court is to hear on May 2 and 3 the
government's request for permission to appeal Botha's original
order. If Botha grants their permission to continue with an appeal effort against the execution order, that will be heard at the same time.
- SAPA
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