DE LILLE BLOWS WHISTLE ON DRUG TRIALS

By Sue Segar

Natal Witness 7 April 2000

Cape Town - Outspoken PAC chief whip Patricia de Lille said on Thursday that she has uncovered a "nest of abuse and exploitation" taking place in clinical trials for a United States-based company on HIV/AIDS patients in Gauteng.

De Lille claims she has exposed a litany of horror stories, ranging from severe side effects of the drugs to irregularities in the way patients were asked to sign consent forms they did not understand.

She has also reported that patients claimed they were told that they would "probably die of HIV anyway" when urged to take part in the trials.

The feisty MP conducted investigations into the trials for the company, named by Minister of Health Manto Tshabalala-Msimang earlier this week as Triangle Pharmaceuticals, at the Kalafong Hospital in Pretoria.

The trials are aimed at investigating the effectiveness of the drug Emtricitabine (FTC). The test involves using a combination of three drugs - FTC or lamivudine (3TC) with stavudine and nevaripine.

In an interview with The Natal Witness, De Lille said she received a call two weeks ago from a group of desperate patients who were suffering from severe side effects from drugs given to them by a Dr M.E. Botes at Kalafong Hospital.

"They told me nightmare stories of the side effects of the drugs, of the way they were given the consent form to sign and of promises of payment. They told me that when they were recruited, they were told that they were HIV-positive and were going to die in any case," she said.

"One patient developed a rash all over the body and still has marks on the face. He told Dr Botes that this had happened since using the drugs, but the doctor said it was not the drugs causing the rash, but the HI virus.

"One woman went completely blind for two weeks. She stopped using the drugs and slowly regained her eyesight. Another patient complained that she could not sleep, that she was vomiting and could not keep any food in her stomach and that she was suffering from depression."

De Lille said that the trials were suspended last week, following her approaches to the Ethics Committee of Pretoria University.

Contacted for comment, Dr Botes said she could not comment because the Medicines Control Council (MCC) and the Ethics Committee are still investigating the matter. She also declined to comment as she has a confidentiality agreement with Triangle.

De Lille has criticised the government, saying that the control of drug trials in South Africa is "useless".

The PAC has demanded that all clinical trials on HIV/AIDS patients in South Africa be suspended until there is a complete register of how many companies, institutions and research organisations are currently running trials and until all applications by such companies are re-evaluated.

Earlier this week, Tshabalala-Msimang announced that any further recruitment of study subjects for clinical trials using the drug Nevaripine will be halted, following the deaths of the women.

The minister said there has been a proliferation of clinical drug trials in SA because South Africans are what is known as "drug naive".

But the PAC refuted this: "It is not the naivety of the people that is responsible for the widespread abuse but the total lack of government control," said PAC health spokesman Costa Gazi yesterday.

"We are an easy target because of government laxity, not the naivety of the people. It is their desperation and poverty that makes them volunteer and, of course, the rich and comfortable do not have to volunteer." "All trials should be suspended until we have proper controls," De Lille said. Meanwhile, the manufacturer of Nevaripine has disputed the claim that the product may have killed the five women in clinical trials.

Tshabalala-Msimang told Parliament on Wednesday that two of the women died of liver damage, and there was "probable" causal association with Nevaripine in the other three cases.

However, a spokesman for Nevaripine manufacturers Boehringer Ingelheim, Kevin McKenna, said from Johannesburg yesterday that the number of deaths is "a matter of some dispute", and the company is seeking clarification.

"My information is that the actual link to Nevaripine is inconclusive, and that the company involved in performing the trials... are involved in examining the [deaths] and establishing the reasons," he said.

And although Tshabalala-Msimang implied that the trials were related to mother-to-child HIV transmission - for which Nevaripine has not yet been registered in SA - McKenna said it was a therapeutic trial for HIV sufferers.

New National Party leader Martinus van Schalkwyk called on the government on Thursday to provide free medicines such as AZT or Nevaripine to infected mothers.

"We must use every means at our disposal to prevent the transmission of HIV, especially from mother to child, rape victims, and those who have been exposed through accidents," he said.

The Democratic Party also called on Tshabalala-Msimang to reconsider her stance involving Nevaripine.

DP spokeswoman on AIDS Sandy Kalyan said that Tshabalala-Msimang's statement that pharmaceutical companies use South Africans as "guinea pigs" and treat them callously will further damage the tenuous relationship with international academics in the field of HIV/AIDS.

Meanwhile, National Assembly speaker Dr Frene Ginwala has granted a DP request for a snap debate on President Thabo Mbeki's "dissident" position on HIV/AIDS. The DP has claimed that Mbeki's "strange stance" is affecting South Africa's international standing in AIDS research.