Important note: Information in this article was accurate in 2003. The state of the art may have changed since the publication date.
Mail & Guardian (Johannesburg) - 1 August 2003
Nawaal Deane
The council was responding to accusations that its rejection of a Ugandan study on nevirapine, which is used to prevent mother-to-child transmission of HIV, was motivated by the government's reluctance to institute a national Aids plan.
The council has given pharmaceutical giant Boehringer-Ingelheim, the manufacturer of nevirapine, 90 days to provide new data on the safety and efficacy of the drug.
The drug will be deregistered if new data are not submitted to the council within the deadline. If the drug is deregistered, the government will be forced to find alternative anti-retroviral drugs in terms of a Constitutional Court ruling last year.
Precious Matsoso, the council's registrar, this week said the government was not behind the decision to reject the findings of the Ugandan study submitted by Boehringer-Ingelheim.
Matsoso said the study did not meet the council's standards. "It would be irresponsible of us to make this a political issue. A letter was written by Boehringer to alert us to the problems in the Uganda trial. How can this be a political issue if they wrote to us?
"We are not a banana regulatory authority, to forget it [evidence] because of an emotive issue."
The pressure is now on Boehringer to provide an alternative study. "I have heard that there is sufficient evidence and it is not difficult for them to find and submit it [before the deadline]," Motsoso said.
030801
MG030802
Copyright © 2003 - Daily Mail & Guardian. For information about the content or for permission to redistribute, publish or use for broadcast, contact the publisher.
AEGiS is a 501(c)3, not-for-profit, tax-exempt, educational corporation. AEGiS is made possible through unrestricted funding from Broadway Cares/Equity Fights AIDS, Elton John AIDS Foundation, the National Library of Medicine, Pacific Life Foundation and donations from users like you.
Always watch for outdated information. This article first appeared in 2003. This material is designed to support, not replace, the relationship that exists between you and your doctor.
AEGiS presents published material, reprinted with permission and neither endorses nor opposes any material. All information contained on this website, including information relating to health conditions, products, and treatments, is for informational purposes only. It is often presented in summary or aggregate form. It is not meant to be a substitute for the advice provided by your own physician or other medical professionals. Always discuss treatment options with a doctor who specializes in treating HIV.
Copyright ©1980, 2003. AEGiS. All materials appearing on AEGiS are protected by copyright as a collective work or compilation under U.S. copyright and other laws and are the property of AEGiS, or the party credited as the provider of the content. .