updated 12/16/2004 6:26:19 PM ET 2004-12-16T23:26:19

Doctors and AIDS activists in Africa are worried governments may halt use of an AIDS drug that has protected thousands of babies from HIV infection in reaction to new concerns about the drug’s testing and effect on pregnant women.

The Associated Press revealed this week that testing of the drug nevirapine at Uganda’s Mulago Hospital failed to meet international standards and that pregnant women who take the drug once to inhibit passing HIV to their babies may develop resistance to it that can limit drug therapies to combat the deadly disease.

Dr. Saul Onyango, a medical officer involved in the testing, said Thursday that officials were worried about the fallout.

“It’s an issue affecting people’s lives. A lot of damage has already been done and we need to do damage control,” Onyango said.

Risks of debate
Dr. Francis Miiro, a key researcher, has dismissed concerns about the testing as discrimination against African scientists and insists the drug works safely.

In South Africa, the Treatment Action Campaign, which lobbied for access to anti-retroviral drugs in that country, warned that reopening debate about the Uganda study could frighten patients off their treatment, even though subsequent research has confirmed nevirapine is safe and effective.

“I don’t see a problem with Nevirapine at all,” said the group’s leader, Zackie Achmat, who found out he was HIV-positive in 1990. “I use it twice daily.”

Doctors working in the public health system, which serves the vast majority of South Africans, have privately expressed fears they will be pressured to stop using single-dose nevirapine for pregnant women before alternatives are available.

“I’m of the view that we should use nevirapine till a better situation can be created,” said Dr. Ashraf Coovadia, head of the pediatric HIV clinic at Johannesburg’s Coronation Mother and Child Hospital. “To halt the program would cause damage to what we have already achieved.”

Worries that drug will be withdrawn
Comment on radio talks shows in South Africa following publication of the AP stories in the local press have included worries that authorities will pull the drug.

President Thabo Mbeki’s government has been criticized for its sluggish response to the AIDS crisis. Until this year, it refused to provide anti-retrovirals through the public health system, citing safety and cost concerns.

In July, a South African regulator recommended a halt to the single-dose nevirapine regime for pregnant women, saying a “cocktail” of drugs should be used instead even though such drugs are expensive and available mostly in the United States and other wealthy nations.

On Wednesday, the Health Department said U.S. concerns about the quality of nevirapine research in Uganda supported its cautious attitude to the drug and it was reviewing its guidelines on mother-to-child HIV transmission.

A spokesman, Sibani Mngadi, said the drug is still distributed by hospitals for now.

“It is part of a public health program which cannot be stopped just because this research is continuing,” Mngadi said.

Studies show that a single dose of nevirapine to an infected woman during labor and another dose to her newborn baby can reduce the chances of HIV transmission by up to 50 percent.

Nevirapine can cause rashes, liver toxicity and even death in some patients who use the drug on a daily basis to treat HIV, but no serious reactions have been reported after a single dose.

But a South African study found that 39 percent of HIV-infected women who get a single dose of nevirapine go on to harbor virus that is resistant to the drug.

Political problem
In Uganda, the official in charge of community health services said the issue had become a political one in the country, often praised for its efforts to stop the spread of AIDS.

“The issue is highly contentious, that’s why some people don’t want to be quoted,” Dr. Sam Okware said. “It’s been going on for two and a half years.”

In a letter obtained by AP, U.S. health officials told Uganda’s government in July 2002 that the research had violated federal patient safety rules. The memos show U.S. officials knew about the problems as early as January 2002, but chose not to tell President Bush before he authorized shipping the drug to Africa later as part of a $500 million initiative.

© 2012 The Associated Press. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.

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