Important note: Information in this article was accurate in 2002. The state of the art may have changed since the publication date.
Sunday Times (Johannesburg) - Sunday 24 March 2002
Bobby Jordan
Government has threatened to deregister the drug due to news of "irregularities" in a key clinical trial begun in Uganda in 1997 which it claims raises doubts about nevirapine's safety.
A spokesman for the US Food and Drug Administration, which has not yet registered the antiretroviral for treatment of pregnant women and infants in the US, described problems with the Ugandan study as "potentially quite serious".
But in a separate statement, an official for the US National Institutes of Health, which conducted an audit of the trial, said while it appeared record-keeping at Ugandan hospitals during the trial did not meet more stringent American regulatory standards, there was no evidence that the conclusions of the Ugandan trial were invalid or that any trial participants had been "placed at an increased risk of harm".
Concerns over the trial have nevertheless prompted nevirapine manufacturer Boehringer Ingelheim to withdraw its application to register the drug for treatment of pregnant women and infants in the US, where it is registered only to treat HIV in adults and in children over the age of two. The company said it intended to re-submit its application once all issues had been resolved.
The WHO and UNAids denied any new safety scare, saying the concerns over the Uganda trial were related to "reporting and documentation irregularities" that did not warrant any change to its recommendations for the widespread use of nevirapine to decrease mother-to-child transmission of the Aids virus.
"We are aware of no information that would cause the WHO and UNAids to change its recommendations," the statement said.
The Minister of Health, Manto Tshabalala-Msimang, and the Health Professions Council on Friday agreed that public sector medical practitioners who faced ethical dilemmas about not being able to prescribe certain Aids drugs should refer their patients to other institutions that were able to do so.
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