PANOS London: Tuesday, September 17, 1996
Martin Foreman

But in a significant development, AIDS activists in Brazil have recently forced their government to purchase these drugs for all HIV positive citizens.

For many years only one class of drugs, known as reverse-transcriptase-inhibitors, had been approved for the treatment of AIDS. Last year scientists in the United States discovered that these drugs, such as AZT and 3TC, were more effective when given in combination.

More recently, therapy based on a new class of drugs called protease inhibitors has been developed. In combination with AZT and 3TC, protease inhibitors produced remarkable results in a small group of patients in the US.

All of these patients had full blown AIDS, and would ordinarily have succumbed to the disease within months. However, on the new combination therapy, some of these patients improved dramatically. Their symptoms vanished and traces of the virus disappeared from their blood. Some left the hospital and returned to work. However, the therapy is not a cure and it has not been shown to eradicate HIV from all tissues.

And though combination therapy has brought new hopes to people with AIDS, it comes at a high price - as much as $18,000 a year - and its long-term effects are not known. Even in the United States, where many patients are covered by insurance or government subsidy, not everyone has access to these drugs and manufacturers and distributors have been accused of capitalising on the desperation of people with AIDS.

In Brazil, one of the worst affected countries, with 500,000 people with HIV, activists have taken legal action to ensure widespread availability of the new drugs.

In March 1995, Merck, the manufacturer of a protease inhibitor called Crixivan, began the world's largest trial of the drug in Brazil.

The trial was divided into three sections. In the first section, 300 people with AIDS received only AZT. In the second, 300 people received both AZT and Crixivan and in the third section, another 300 received only Crixivan. The aim was to compare the progress of patients in all three sections to determine which therapy was most effective.

By October 1995, according to Mario Scheffer of a local AIDS organisation called Grupo pela VIDDA (GpV or Group for Valorisation, Integration and Dignity for people Ill with AIDS), it became clear that participants receiving only AZT were seeing no improvement in their health whereas those receiving Crixivan alone or Crixivan plus AZT fared much better.

GpV, many of whose members were participating in the trials, approached Merck and asked them to change the protocol of the trial so that all patients received some form of combination therapy.

At the same time, the group sued the doctors working on the trial for misconduct, alleging that it was irresponsible to deny participants receiving AZT alone access to treatment that had provided clear health benefits to others.

Further pressure on Merck came during an international conference on AIDS treatment held in Washington DC in January 1996 when the efficacy of combination therapy became clear.

In July 1996, the company agreed to give participants receiving AZT alone and Crixivan plus AZT, a third drug - 3TC. Subsequently, GpV withdrew its legal action against the doctors, but maintained the position that the participants in the third section, taking only Crixivan, should also be given 3TC, so that they too might benefit from combination therapy.

"If members of the third section are not offered 3TC," Scheffer says, "we will urge everyone, in all three sections, to abandon the trials." If the trials are abandoned, it will be a major setback for Merck's plans to prove the efficacy and viability of Crixivan worldwide.

In a second legal action, twenty patients=with GpV backing=sued the federal government, which provides health care to all citizens, for not providing combination therapy for AIDS.

In mid-July the Brazilian Minister of Health announced that the federal government will meet 70 percent of the cost of combination therapy for everyone in the country who needs it. Individual states were made responsible for the remaining 30 percent of costs. However, Scheffer fears that because demand for the new drugs is so high in North America and Europe, it may be some time before manufacturers can supply all the drugs necessary in Brazil.

The main problem, according to Scheffer, is not HIV, but Brazil's generally weak health structure.

As in many developing countries, public hospitals are overcrowded and understaffed and many people on the margins of society have little or no access health care. To provide combination therapy to all who need it in Brazil, the federal government will have to spend more than $42 million with a further $18 million coming from the states.

As the AIDS epidemic matures and many more people become ill, this cost will increase substantially unless the price of AIDS treatment goes down.

Pharmaceutical companies justify the high price of combination therapy by citing the cost of the research that went into developing it. But David Barr, a treatment expert at the Gay Men's Health Crisis in New York, feels that drug companies are not transparent enough about these costs.

"Whether protease inhibitors are overpriced or not is difficult to evaluate. I'm not opposed to a manufacturer charging a reasonable price, and that includes a reasonable profit, but one of my real criticisms of the industry is that they will never release their research and development costs."

John Shapiro, an AIDS researcher at Stanford University in the US, believes there is a problem with AIDS research today.

'It's important to realise that most of the people with HIV in the world cannot afford the drugs we are working on, and I think we have to look at other options such as education about HIV and [developing] vaccines to prevent transmission which would be more applicable to the general population of the globe, and not these very expensive drugs which, I think, realistically most people will not be able to receive."

The overwhelming majority - nine out of ten - of the estimated 21 million people with HIV world-wide are in developing countries.

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