S. Africa AIDS Groups Fear Effect of Nevirapine Move
By Silvia Aloisi
Originally published by Reuters, March 26, 2002
JOHANNESBURG (Reuters) — South African AIDS campaigners said on Tuesday they feared the government would use a decision by a drugmaker to drop plans to get wider marketing permission for a key AIDS treatment in the US as a pretext to reject it.
Nevirapine, developed by private German company Boehringer Ingelheim, has been shown to cut by half the risk of an HIV-infected mother passing the virus to her baby.
But the government of South Africa, which has the highest rate of HIV infection in the world, has so far prohibited the use of nevirapine beyond a number of pilot projects on cost and safety grounds.
And the country's medical regulatory body is now reviewing nevirapine's registration after Boehringer dropped plans last week to have the drug approved by the US Food and Drug Administration (FDA) for use in preventing mother-to-child transmission of HIV/AIDS.
Boehringer and US health officials backing the drug say the application withdrawal was due to procedural problems with data collected from a 1999 drug trial in Uganda and had nothing to do with the safety and efficacy of nevirapine.
AIDS campaigners accused the government of playing dirty tricks by using the application withdrawal to spread doubts over the drug. "The government has managed to confuse the public—they should be ashamed that scoring political points is more important for them than saving thousands of children's lives," said Nathan Geffen of the Treatment Action Campaign.
"There is no question that the drug works and is safe," said John La Montagne, deputy director of the US National Institute of Allergy and Infectious Diseases.
"It is an issue of reconstructing the (hospital) records…it is a matter of making sure you generate the data to the satisfaction of the FDA," he told a video conference in Johannesburg.
He said it was understandable that the trial records may be incomplete "if you think of the sort of hospitals they had to deal with (in Uganda)."
The FDA has already approved the use of nevirapine for the treatment of HIV infection in adults and children.
Also, a US public health service taskforce currently recommends the drug as an option for the prevention of mother-to-child transmission based on the results of the Uganda studies.
A Pretoria High Court ruled on Monday that the South African government must provide nevirapine to HIV-positive pregnant women at all state hospitals and clinics with the capacity to do so, while an appeal is heard in the Constitutional Court.
The government appeal against a December High Court ruling that the state had a constitutional duty to widen access to nevirapine will be heard on May 2 and 3.
However, government lawyers told the High Court that nevirapine pilot projects in South Africa could be suspended if registration for the drug was withdrawn.
"It's very scary," said Kelly Hatfield of advocacy group People Opposed to Women Abuse. "The government is showing an ostrich mentality—burying its head in the sand and hoping that the AIDS problem will just go away."
It is estimated that one in nine South Africans are infected with HIV—around 5 million people—and 70,000 to 100,000 babies are born HIV positive each year.
