SAPA 23 April 2000

A 40-year-old woman died on Friday after allegedly taking part in a Pretoria AIDS drug trial that has already claimed the lives of five other women, a correspondent reported on Sunday.

Earlier this month, the Medicines Control Council suspended recruitment of further patients for the study, known as the FTC-302 trial, which is being conducted by Quintiles Clindepharm on behalf of Triangle pharmaceuticals, a United States company.

Sources at Kalafong Hospital, in Pretoria, confirmed the death of the woman due to liver failure - a well-known side-effect of the cocktail, which includes Nevirapine and AZT clone, Zerit.

The name of the woman, whose death has not been confirmed by officials due to the Easter weekend, is being withheld at the request of the family.

They indicated that further steps were being considered.

The woman's family said they were told about her death on Friday.

"We received a telephone call from a nurse to say that my mother had passed away on Friday," said the woman's 24-year-old son from his Atteridgeville home.

"My mother's uncle and aunt went to the hospital to make sure. The body is now at Kalafong's mortuary."

He said he last saw his mother on Wednesday afternoon and she was "very weak", but could still speak.

The son said the family could only speak to a doctor on Tuesday.

Drug trial investigator Dr Mariette Botes has denied that the patient had ever taken part in the AIDS drug trial.

She also denied that the woman had taken any AIDS drugs.

However, Sapa has a copy of a signed consent form for the clinical trial, signed by the patient and listing Botes as the investigator.

Naomi Mashego, a social worker for the Mental Health Society who ran a support group in Atteridgeville for people living with HIV, said the woman had told Mashego that she was taking part in the trial.

The woman had apparently discussed some of the health problems she was having on the trial, particularly in connection with her liver.

Reverend Johan Viljoen, a friend and counsellor of the deceased, said that when he went to visit the woman on Friday evening, her bed was empty.

"I asked whether she had been discharged, but was told that she had passed away that afternoon," he said.

Viljoen said the woman told him last year that she was participating in the drug trials.

He said the woman had to be admitted to hospital soon after starting the trial due to a liver complaint. The woman had not previously complained of liver problems.

"I looked at her Kalafong medical file this week and it stated clearly that she had liver problems, the same symptoms I had seen on the drug's information leaflet before."

The woman's family said she complained continually of nausea, vomiting and diarrhoea, symptoms attributed to the drugs.

Viljoen accused the companies of "exposing healthy people to toxic poisons".

"She had been healthy for the last six years. Then she deteriorated rapidly once going on to the AIDS drugs," he said.

On Saturday, Pan Africanist Congress MP Patricia de Lille said that suspension of the trials was not enough.

"The government must round up all the people who have taken part in the trials and examine them for side effects, before more people die."

She also complained that the trials were not properly monitored.

"We still don't have the medical or trial files of the patients, even after it was specifically requested. Nor do we know how much money was paid to the doctors to conduct the trials."

Patients on the trial had also made complaints about not being given access to their medical files.

Speaking for Manto Tshabalala-Msimang, the minister of health, Patricia Lambert said doctors or nurses withholding medical files from patients should be reported to the Human Rights Commission.

"Every single adult has a constitutional right to medical information that concerns his or her own body," she said.

Lambert confirmed that a report from the Medicines Control Council relating to the previous deaths on the trials would not be accessible to the families of the five.