Sunday Times, South Africa - April 9, 2000
Laurice Taitz
On Wednesday Tshabalala-Msimang told Parliament that the women had died "during the course of an ongoing clinical trial involving Nevirapine". She said: "According to the Medicines Control Council report, two of the deaths were due to hepatitis. The report further cites the causal association between Nevirapine and the deaths as probable in three of the five cases."
But in a statement on Friday the chairperson of the Medicines Control Council, Dr Helen Rees, said "no conclusive cause and effect" had been established in the deaths of the people who had taken part in a clinical trial called the FTC 302 trial at Kalafong Hospital, in Pretoria.
The trial, conducted by Quintiles Clindepharm, a South African subsidiary of US-based Triangle Pharmaceuticals, was intended to assess the use of a combination therapy or "drug cocktail" in the long-term treatment of adult HIV infection.
Nevirapine, manufactured by Boehringer Ingelheim, was one of three drugs used in the trial.
Referring to the deaths, Rees said: "One explanation is that there may be a drug interaction involving any two of the three drugs used, including the study drug Emtricitabine and one of two other trial drugs, Stavudine and Nevirapine."
The Medicines Control Council has ordered that recruitment of trial patients be halted in the FTC 302 study and is conducting a detailed review of the study.
The drug Nevirapine was thrust into the spotlight last year after research in Uganda showed it was cheaper and more effective than AZT in reducing the transmission of HIV from mother to child. Since July clinical trials have been conducted at 11 South African research sites to test how effectively the drug prevented maternal transmission. These trials, collectively called the Saint Trial, are continuing.
Rees made it clear that the results of the FTC trial did not in any way affect the tests of the other drugs.
She said: "It is important to note that this reaction [toxicity] has not been seen to date in the mother- tochild transmission studies where Nevirapine is given as a single dose to both the mother and the infant."
Researchers taking part in the Saint Trial, led by Professor Jerry Coovadia, paediatric head at the University of Natal Medical School, in a statement expressed their concern over the minister's announcement.
PAC MP Patricia de Lille slammed the minister's statement, saying: "It is unfortunate that she used the tragic event of deaths during the trials to make a political point that justifies her doing nothing to stop mother-tochild transmission."
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