SAPA 28 Oct. 1999

International medical company Glaxo Wellcome said on Thursday that President Thabo Mbeki had been misinformed about the safety of the anti-AIDS drug AZT.

In a statement in Johannesburg it said that after extensive international and local trials carried out on AZT, the medicine was approved safe to use even in countries with stringent regulations such as the United States and Germany.

The company said South Africa's Medicines Control Council joined the US Food and Drug Administration and its United Kingdom counterpart about 10-years ago in giving AZT its stamp of approval.

It said the MCC had not indicated to it any concerns about the drug since being introduced into the country.

"For more than a decade, AZT has extended and improved the quality of life of millions of people living with HIV/AIDS around the globe," Glaxo Wellcome SA medical director Peter Moore said.

On Thursday, Mbeki attempted to take the heat off his government and the public health service on the issue of AZT (Azidothymidine), by saying it could be dangerous to those who take it.

Addressing the National Council of Provinces in Cape Town, he said many people had urged the government to make the drug available in the public health system.

Mbeki was referring to calls from, among others, rape survivors themselves that the drug be made freely available at hospitals and clinics.

There are also calls for the drug to be given to pregnant women with the HIV virus.

"We are confronted with the scourge of HIV/AIDS against which we must leave no stone unturned to save ourselves from the catastrophe which this disease poses," Mbeki said.

However, it would be irresponsible not to heed the dire warnings which medical researchers were making about AZT, he said.

Two issues had come to the government's attention.

One of these was that there were legal cases pending in South Africa, the United Kingdom and the United States against AZT, on the basis that the drug was harmful to health.

There also existed a large volume of scientific literature which claimed that the drug's toxicity was a danger to health, Mbeki said.

"These are matters of great concern to the government, as it would be irresponsible not to heed the dire warnings which medical researchers have been making."

Moore said Glaxo Wellcome had not been notified about any pending court cases regarding the safety of AZT in South Africa or overseas.

He said AZT had been authorised by the FDA, MCC in South Africa, and the Centre for Disease Control in Atlanta, for use in pregnant women after their first trimester to prevent mother-to-child transmission of the virus.

Mbeki asked Health Minister Manto Tshabalala-Msimang, as a matter of urgency, to investigate the concerns about AZT "so that to the extent that is possible, we ourselves, including our country's medical authorities, are certain of where the truth lies".

Tshabalala-Msimang told reporters afterwards that there was a body of scientific research and information which indicated that AZT was indeed a dangerous drug, and had not been designed for the treatment of HIV/AIDS.

Because it was unable to target only the human immunodeficiency virus when it went to work in the body, it further weakened the immune system.

There was also a danger that because of "mutation", mothers taking the drug might produce children with disabilities.

Tshabalala-Msimang said her ministry would not like to look back 10 or 15 years down the line and find it had exposed the "vast majority" of historically-disadvantaged people in South Africa to a dangerous drug.

"We have to be very cautious, very sensitive," she said.

She also said there was no data proving that AZT was of any use to rape victims.

Moore said he was concerned that Mbeki was encouraging NCOP members to access information about the drug on the internet which he said was not routinely medically reviewed and should not be considered as being necessarily correct.

He said Mbeki's views could potentially raise unwarranted concerns among patients using AZT leading them to stop the treatment without consulting their doctors.

"Glaxo Wellcome applauds the president's commitment to fighting this scourge in South Africa and welcomes the opportunity to discuss with him any concerns he may have regarding the safety of AZT, as the company honestly believes that in this case the president has been misinformed," Moore said.