AP 3 Nov. 1999

JOHANNESBURG - President Thabo Mbeki's claim that a widely used AIDS drug is dangerous has set off an uproar, producing bafflement and shock among physicians and advocates who say AZT is safe.

The drug is the mainstay of efforts around the world to prevent HIV-infected mothers from passing the AIDS virus to their babies during birth.

Mbeki said in Parliament last week that AZT is toxic and was being challenged by court cases in the United States, Britain and South Africa - a claim the manufacturer, Glaxo Wellcome PLC, has hotly denied.

The issue is critical in a nation with one of the world's worst AIDS problems, where 3.6 million people, or 8 percent of the population, are estimated to be HIV positive. The controversy threatens to set back efforts to fight the disease.

In his speech Thursday, Mbeki spoke of a "large volume of scientific evidence alleging that, among other things, the toxicity of this drug is such that it is in fact a danger to health.''

Mbeki said that it would be "irresponsible'' not to heed the "dire warnings'' of researchers about the safety of AZT, which is one of the world's oldest and best-known AIDS drugs. Reputable scientists have issued no such warnings, and it was unclear what he was referring to.

On Tuesday, the government promised to investigate the safety of AZT. Mbeki said he has asked the health minister, Manto Tshabalala-Msimang, to oversee the inquiry.

Tshabalala-Msimang told the South African Broadcasting Corp. that AZT would not be barred from the market but she was deciding how to investigate the matter "so that we really have concrete information in our hands.''

The drug has been approved by regulators in South Africa and around the world, and is commonly used in combination with other drugs to control the AIDS virus or prevent infection among health care workers exposed to it. Many studies have shown that AZT cuts in half the risk that women will infect their babies during delivery.

AZT, also known as zidovudine, is "perfectly acceptable'' in those three areas, said Dr. Joseph Perriens, head of the care and support division of the U.N. AIDS program in Geneva. It causes slight side effects like nausea or anemia, but, he noted, so do many medicines.

Worries about AZT's safety surfaced in the early 1990s but have long faded, Perriens said. French researchers reported in February that two babies who had received AZT in a study had died, but no link between the deaths and the drug was established.

Perriens suggested Mbeki "inform himself better about the toxicity of (the drug), which is not really as serious as he thinks, and he should probably recast the debate in terms of cost. It's not doing his people a service.''

With an average of 1,500 South Africans infected with HIV each day, the government has come under increasing pressure to provide drugs like AZT to infected pregnant mothers and rape victims. The government has said before that it cannot afford to do so, but this is the first time in the public debate than an official has so forcefully said a health danger is the reason.

Mbeki's comments are "very distressing because it sets back the whole agenda once again'' after previous controversies, such as a scandal-plagued anti-AIDS musical, which paralyzed the government AIDS program, said Dr. Saul Johnson, a pediatrician and researcher at Chris Hani-Baragwanath Hospital in Soweto, where AZT has been studied as a way to prevent mother-child transmission.

"It raises the issue of where he gets advice,'' he said.

A presidential spokeswoman was quoted over the weekend as saying Mbeki received his information from the Internet.

"I think if the president doesn't want to provide AZT, he should find an excuse based on fact,'' said Dr. Salim Abdool Karim, head of AIDS research at the Medical Research Council, which is similar to the U.S. National Institute of Health.

"It's the standard of care in many countries,'' he said.

When asked why Mbeki would make such a statement, he said: "I can only assume that he has been given this information and accepted it in good faith. I don't think the president would deliberately try to mislead us.''