Puzzling delay in nevirapine programme

Cabinet is the latest barrier standing between HIV positive pregnant women and the anti-retroviral drug, nevirapine, which can save their babies from the virus.

Despite advanced preparations for a government programme to issue nevirapine to pregnant women at 18 sites countrywide, Health Minister Dr Manto Tshabalala-Msimang recently decided that the nevirapine programme needed Cabinet approval.

Her decision has baffled healthworkers countrywide, many of whom have worked flat out to prepare for the nevirapine programme, which was due to begin in five provinces on 1 April.

It has also prompted speculation of top-level political interference in what will be the de facto beginning of a government drug treatment plan for people with HIV/AIDS.

President Thabo Mbeki has often expressed scepticism about the use of drugs to combat HIV/AIDS, and in the past labelled the anti-retroviral drug, AZT, as toxic.

The nevirapine programme has been in the pipeline since July last year, when it was approved by the health Minister and provincial MECs. Nevirapine can cut mother-to-child transmission of HIV by up to 50%.

Drug trials completed nine months ago proved the safety and efficacy of the drug, and drug company Boehringer Ingleheim has offered government a free supply of nevirapine for five years.

KwaZulu-Natal Secretary for Health Dr Ronald Green-Thompson was unaware that the programme, which “has the approval of MinMEC”, needed to go to Cabinet.

“We need to implement this as soon as possible,” said Dr Green Thompson, who works in a province where 36% of pregnant women have HIV.

The Treatment Action Campaign’€™s Zackie Achmat said both government and the Medicines Control Council (MCC) were complicit in babies’€™ deaths from AIDS-related illnesses.

The MCC has been discussing the registration of the drug for mother-to-child transmission since the middle of last year.

Although the MCC is now convinced of the scientific value of nevirapine, it will not register the drug unless Boehringer Ingleheim agrees to monitor drug resistance, according to MCC chairperson Dr Helen Rees.

However, Rees says the 18 sites should be able to go ahead and issue nevirapine within a month.

Staff in the provinces are intensely frustrated by the delay. Working to very tight deadlines, nurses in the five provinces were trained to run HIV tests, counsel pregnant women and administer nevirapine. Training is ongoing in the other four provinces.

“My staff can’€™t wait to start, and all that we are waiting for is approval of the drug and a supply of nevirapine,” said Free State official Ms Lache Katzen.

The Northern Cape, KwaZulu-Natal and parts of Gauteng were also ready. The Western Cape started giving nevirapine to HIV positive pregnant women in Gugulethu on 1 January, but faces possible legal action from the MCC.

The tension generated by the delay was evident when Chief Director of HIV/AIDS, Dr Nono Simelela, broke down in tears at a weekend conference after being accused of complicity in babies’€™ deaths by the Treatment Action Campaign’€™s Zackie Achmat.

“It is unfair to suggest that I have delayed the programme’€¦As a mother and as an obstetrician, I chose to do this job and feel the love and drive to do it,” sobbed Dr Simelela, while addressing the AIDS in Context conference at Wits University.

Dr Costa Gazi, PAC secretary for health, said Dr Simelela’€™s reaction “reflects the frustration she must be feeling in the department”, and had convinced him that government was going to do “nothing” about preventing mother-to-child transmission of HIV.

Dr Gazi is part of a growing number of doctors in state hospitals who, tired of government delays, have bought nevirapine privately and are issuing it on-the-quiet to pregnant HIV positive mothers.

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