'What about the babies?'

2003-07-30 08:50

Antoinette Pienaar

Johannesburg - The Medicines Control Council's (MCC) decision to reject the nevirapine study done in Uganda has come barely 10 days after the World Health Organisation (WHO) announced that "administrative problems" do not affect information about the efficacy of the drug.

The manufacturing company, Boehringer Ingelheim and scientists were astounded on Tuesday to hear the MCC was re-considering the registration of the drug for use in countering mother-to-child transmission of HIV/Aids.

Boehringer Ingelheim has 90 days to submit new information to prove nevirapine's efficacy.

Registration for the general use by adults is not being questioned.

"What is going to happen to all the thousands of babies exposed to the virus?" asks Dr Glenda Gray, director of the HIV research unit at Chris Hani-Baragwanath Hospital in Soweto.

She says a million women give birth in South Africa annually and about a quarter of them are HIV-positive.

"There's enough published and unpublished information to confirm that nevirapine reduces the spread to 12%.

"It is unethical to conduct tests with placebos, but everyone knows the spread without intervention is nearly 25% in developing countries."

Kevin Mckenna, a director of Boehringer Ingelheim, says his company and the National Institute of Health in the United States discussed the administrative problems the Ugandan study had encountered.

The WHO said on July 16 that the Institute of Health had established that those problems didn't affect the efficacy of nevirapine.

The American Food and Drug Administration turned down the findings of the study because of poor documentation and the MCC concurred.

The WHO said, though, that it still supported the use of nevirapine to prevent the spread of HIV.

Mckenna says Gray and other scientists recently confirmed their support for the drug in a document sent to the MCC. Their decision was supported by research conducted worldwide.

Tanya Doherty of the Health Systems Trust, which co-ordinates the government's nevirapine programme, said from Sweden that the latest report about the drug had been passed on to the health department.

The researchers cannot, however, use the information about the efficacy of the drug because only between 10% and 50% of mothers and babies returned for follow-up visits.

- Beeld