Controversy erupts over nevirapine administration
Aug 17, 2003
UGANDAN experts have dismissed claims by South Africa that a research which led to the discovery that nevirapine could prevent HIV infection from mother to child, was not valid.
By Charles Wendo
UGANDAN experts have dismissed claims by South Africa that a research which led to the discovery that nevirapine could prevent HIV infection from mother to child, was not valid.
Prof. Francis Mmiro of the Faculty of Medicine, Makerere University, carried out the experiment in Kampala, in collaboration with American colleagues. They published the results in July 1999. The team discovered that a single dose of the drug during labour could reduce mother-to-child HIV transmission by half.
After consulting with international experts the World health Organisation recommended nevirapine for use in the prevention of mother-to-child HIV transmission.
However, South Africa on July 28, rejected the Ugandan study, questioning the safety and effectiveness of the drug. The South African Medicines Control Council (MCC) said the researchers did not provide sufficient proof that the drug saves babies. The council also says records did not match the announced results. It adds that some records were missing.
“It is therefore no longer valid for the MCC to continue to approve the use of nevirapine as a single agent for reducing the risk of HIV transmission from mother to child,†the council said.
But Prof. Mmiro, the man behind the discovery, said South Africa’s decision was more political than scientific.
“South Africa has its own problems. A whole head of state told us he is not sure HIV is the cause of AIDS,†he said.
He added, “Sixty countries are doing nevirapine. Are they stupid? A research was done in Durban (South Africa) and it showed that nevirapine is effective. What is wrong with them?“If South Africa doesn’t use nevirapine, who cares? It is their women and their childrenâ€
“We have not seen anybody dying from toxicity from this drug. If they are talking about toxicity, then why are they allowing it for treatment of AIDS patients, which is even for a longer period?†he said
Prof. Fred Wabwire-Mangen of the Makerere University Institute of Public Health said all drugs have side effects. “With drugs you weigh the benefits and risks. In this case the benefits far outweigh the risks,†he said.
Dr Paul Bakaki, a paediatric researcher with the Makerere University-John Hopkins University collaboration project, said further research in other countries had confirmed that nevirapine was safe and effective.
The AIDS Control Programme manager, Dr Elizabeth Madraa, said they would ignore the noise made by South Africa and continue to implement nevirapine programmes. “Many countries are using it. It is only South Africa making noise,†she said.
The US Food and Drug Administration was the first to raise queries about Mmiro’s experiment in March last year. The US sent to Uganda, a team of independent science auditors. In March this year the US National Institutes of Health reported the results of the audit, that there were documentation irregularities, but nevirapine was safe and effective.
UGANDAN experts have dismissed claims by South Africa that a research which led to the discovery that nevirapine could prevent HIV infection from mother to child, was not valid.
Prof. Francis Mmiro of the Faculty of Medicine, Makerere University, carried out the experiment in Kampala, in collaboration with American colleagues. They published the results in July 1999. The team discovered that a single dose of the drug during labour could reduce mother-to-child HIV transmission by half.
After consulting with international experts the World health Organisation recommended nevirapine for use in the prevention of mother-to-child HIV transmission.
However, South Africa on July 28, rejected the Ugandan study, questioning the safety and effectiveness of the drug. The South African Medicines Control Council (MCC) said the researchers did not provide sufficient proof that the drug saves babies. The council also says records did not match the announced results. It adds that some records were missing.
“It is therefore no longer valid for the MCC to continue to approve the use of nevirapine as a single agent for reducing the risk of HIV transmission from mother to child,†the council said.
But Prof. Mmiro, the man behind the discovery, said South Africa’s decision was more political than scientific.
“South Africa has its own problems. A whole head of state told us he is not sure HIV is the cause of AIDS,†he said.
He added, “Sixty countries are doing nevirapine. Are they stupid? A research was done in Durban (South Africa) and it showed that nevirapine is effective. What is wrong with them?“If South Africa doesn’t use nevirapine, who cares? It is their women and their childrenâ€
“We have not seen anybody dying from toxicity from this drug. If they are talking about toxicity, then why are they allowing it for treatment of AIDS patients, which is even for a longer period?†he said
Prof. Fred Wabwire-Mangen of the Makerere University Institute of Public Health said all drugs have side effects. “With drugs you weigh the benefits and risks. In this case the benefits far outweigh the risks,†he said.
Dr Paul Bakaki, a paediatric researcher with the Makerere University-John Hopkins University collaboration project, said further research in other countries had confirmed that nevirapine was safe and effective.
The AIDS Control Programme manager, Dr Elizabeth Madraa, said they would ignore the noise made by South Africa and continue to implement nevirapine programmes. “Many countries are using it. It is only South Africa making noise,†she said.
The US Food and Drug Administration was the first to raise queries about Mmiro’s experiment in March last year. The US sent to Uganda, a team of independent science auditors. In March this year the US National Institutes of Health reported the results of the audit, that there were documentation irregularities, but nevirapine was safe and effective.