- While the main drug preventing mother-to-baby HIV transmission, Nevirapine, is increasingly made available free of charge in most of Africa, the South African government continues to contest the drug. The producer has been given 90 days to prove the safety, or Nevirapine will be banned as a legal drug.
The decision by the South African Medicine Control Council (MCC) to demand more documentation on Nevirapine has caused protest reactions in the country. The Council's decision comes after fierce government resistance to accept the free distribution of AIDS drugs in South Africa.
The MCC yesterday gave Nevirapine manufacturer Boehringer-Ingelheim 90 days to prove the effectiveness and safety of the drug for single- dose use. The MCC said it had rejected the HIVNet012 study conducted in Uganda - regarded as the "pivotal study" on which it based its registration of Nevirapine for single-dose use in the prevention of mother-to-baby HIV transmission.
Nevirapine only last year became South Africa's first legally registered anti-retroviral drug after AIDS activists had won a large legal battle forcing the government to provide it for HIV-positive mothers. If the MCC is not satisfied with new proof to be delivered by Boehringer-Ingelheim, the drug may be deregistered again.
The perplexed German manufacturer however says it cannot understand the MCC's problem, which seems to become a rerun of two controversial cases last year. The contested Ugandan study of Nevirapine however had been shown to include several methodological errors.
Boehringer-Ingelheim also refers to the World Health Organisation (WHO), which on 16 July said that it was satisfied that the "administrative problems" with the trials of Nevirapine in Uganda do not affect the efficacy of Nevirapine and that it still supported the use of Nevirapine to prevent the spread of HIV.
Nonetheless, the drug has been seen to work in Africa, where it is freely distributed to HIV-positive in many countries and is seen to prevent more than half of the transmissions to the unborn child.
In South Africa alone, an estimated 100,000 babies are born HIV-positive each year - something AIDS activists say could be reduced to less than half if government cooperated in the distribution of Nevirapine.
Thus, the controversial decision by the MCC already has caused strong reactions in South Africa. In the opposition-led Western Cape Province, which had been among the first to provide Nevirapine to HIV-infected mothers, authorities are "astonished" by the possible reversal of the drug's approval.
Dr Fareed Abdullah, head of the Western Cape's AIDS programme, today told the press the new situation created by the MCC was "completely unhelpful". The official added that the safety of the drug was "well-established and that should be their main concern."
Also the country's main trade union, COSATU, today protested the MCC's decision. "We remain convinced that this drug can prevent mother-to-child transmission of the virus and save hundreds of babies from being born with HIV/AIDS and dying an unnecessary, early death," said COSATU spokesman Patrick Craven.
- While no drug can ever be 100 percent risk-free, the evidence available indicates that the advantages in saving lives far outweigh the possible risks and side effects, Mr Craven added, saying the trade union was concerned that "lives could be lost as a result of this further delay in allowing the distribution of Nevirapine to HIV-positive pregnant women."
Also the AIDS activist group Treatment Action Campaign (TAC) reacted with outrage to the news. TAC claims that the government is downplaying the AIDS pandemic in South Africa. "According to a official report, which has still to be released, ante-natal HIV prevalence in SA in 2002 reached 26,5 percent. HIV related deaths number over 600 a day," TAC claims.
The new MCC offensive is widely seen as just another government attack on the agreement reached between authorities, trade unions, industry and civil society to forcefully fight the AIDS pandemic. The efforts to create a national AIDS plan have however been derailed for 8 months due to government delays in reviewing proposals by civil society.
Also the trade union shares this view: "COSATU trusts that this decision to reconsider the use of Nevirapine will not become an excuse for any further delay by the government in signing the draft NEDLAC agreement on a national plan for the prevention and treatment of HIV/Aids, which has been on the table since October 2002 and that antiretroviral treatment will be made available to all who need it with the utmost urgency in all state hospitals and clinics," Mr Craven says.
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