PANOS London - Monday, June 2, 1997.
Thalyta Swanepoel

Increasing numbers of hopeful AIDS and HIV-positive patients in South Africa are being left in the lurch after drugs tests, prompting a debate throughout the medical fraternity. And pharmaceutical companies are coming under fierce attack from medical investigators and ethicists who accuse them of violating human rights.

"A lot of patients doing very well on combination therapy became very sick when the drugs were withdrawn at the end of the trial," says Dr David Spencer, a senior physician at Witwatersrand University. "In rich countries, combination therapy of some kind is usually available through the public health system, but in poor countries there is nothing. So people who volunteer for trials must be given drugs indefinitely by the companies."

Current state-of-the-art AIDS treatment comprises a cocktail of different drugs, known as combination therapy. While not a cure, it has been shown to improve the well-being and extend healthy life for some people with HIV - the virus that causes AIDS. The effects, which have been widely publicised (thus raising hope), can be dramatic. But the drugs can cost up to $20,000 per patient per year.

In South Africa, these drugs are only available through the private health sector, usually at full price - naturally, only a handful of its 2.5 million HIV positive citizens can afford them. On the other hand, several thousand patients have access to treatment through short-term HIV/AIDS drug trials run by multinational pharmaceutical companies. At least 10 are currently underway.

Medical ethics committees throughout South Africa are now debating whether to approve HIV drug trials that fail to provide long-term supplies of desperately-needed medicines. Campaigners are threatening one pharmaceutical company with legal action for failing to supply long-term treatment for 35 former trial subjects.

Developing countries like South Africa offer several advantages to pharmaceutical companies wishing to test drugs. More HIV-positive people from diverse ethnic groups make for more accurate data; patients are less likely to have developed resistance to trial drugs because (unlike patients in the West) most have not taken other AIDS drugs in the past; and medical costs such as salaries and hospital fees are lower.

Nine out of ten people with HIV live in developing countries. And while a number of international agreements, like the Helsinki Declaration of Human Rights, have established guidelines for ethical conduct of medical research, there is no global mechanism for enforcing these guidelines. Drug companies are often permitted to work out their own rules.

In the past, most companies used to provide treatments for trial subjects for their whole lives, but this was when treatment consisted of only one drug. Combination therapy often uses drugs made by different pharmaceuticals, and companies say they cannot afford to provide life-long supplies of drugs which they have to buy from other companies.

"Providing extended free drugs would be very expensive and impractical," says Charles de Wet, medical director of the Austrian pharmaceutical company, Boehringer Ingelheim.

De Wet's company is currently conducting a trial of Nevirapine - the first of a new generation of AIDS drugs - in South Africa, the United States and Europe. The company says it will invest seven million dollars in South Africa through the Nevirapine study. De Wet says that by the end of the trial, each of the 500 patients will have received drugs worth between R60,000 and R70,000 ($14,000.)

Nevirapine will continue to be provided after the trial, but not in conjunction with other drugs, such as AZT and 3TC, which are provided during the trial. And Nevirapine too will be withdrawn once the drug is registered, and patients will have to pay for it.

Such practices are a body blow for AIDS patients like 41-year-old Nic, who has been in and out of trials for years. "When one has AIDS, one tends to continuously look for ways and means to find the drugs cheaper. While one always knows up front whether to expect free drugs after the trial is over, it is difficult not to hope that a company will change its mind. I will always try again," Nic says.

"Patients know what they let themselves in for," says de Wet, referring to the consent form patients must sign for the trial. Peter Cleaton-Jones, Chairman of the committee for Research on Human Subjects, disagrees: "South Africa has large numbers of people insufficiently educated to understand the implications of what they are doing," he points out.

It is doctors dealing directly with frustrated AIDS patients who most often have to bear the brunt of their anger. "They are sweating blood to get the best deal for their patients," says Gavin Damster of the Medical Association of South Africa.

Individuals on all sides face a profound moral dilemma. In Johannesburg, family-doctor David Johnson has begun enrolling some patients in trials that do not pay for long-term therapy. "There are many patients who may not survive the next two years without intervention - so at least I can offer them something," Johnson says. "The only way to deal with expenses is by entering clinical trials."

While some critics argue that the ethics of testing expensive drugs in a poor country are dubious, there is a glimmer of hope that combination drug therapy might one day become affordable to the majority of South Africans.

UNAIDS - the United Nations body coordinating global AIDS activity - is initiating regional actions to improve access to drugs in developing countries. "Some drug companies seem willing to consider making drugs available at very low cost for developing countries," says Rose Smart, director of the Department of Health's HIV/AIDS and Sexually Transmitted Diseases Programme.

Meanwhile, the ethics committee at Witwatersrand University is trying to persuade companies to provide long-term treatment to at least those patients who do particularly well during the trial.

"We realise we can no longer insist on life-long provisions for everyone, because there are just too many drugs. But we are trying to get companies to identify and help those patients that seem to benefit most," says Cleaton-Jones.

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