Prostitutes succeed in halting Aids drug trials in Cambodia

CAMBODIA: Some websites link the pill tenofovir with side effects like kidney problems and osteoporosis, writes Ariana Eunjung…

CAMBODIA: Some websites link the pill tenofovir with side effects like kidney problems and osteoporosis, writes Ariana Eunjung Cha in Phnom Penh

Yunang Soma stood shoulder to shoulder with other prostitutes on a makeshift stage in a park and shouted to the crowd: "The US says it wants to help poor people, but it is killing the poor people!"

She was protesting against a trial of the drug tenofovir, which scientists think may one day serve as an effective "chemical vaccine" against the human immunodeficiency virus, which causes Aids.

Unlike true vaccines, which give a lasting immunity to a disease but have proved difficult to develop for HIV, tenofovir is a daily pill. Scientists hope it will protect against infection for a few hours or maybe even days.

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The trial, funded by the Bill & Melinda Gates Foundation, was designed to see if it can stop people from becoming infected with HIV even if the virus enters their bodies.

Researchers however have run into a highly organised opposition that they say was engineered by foreign activists. The demonstrators have succeeded in shutting down the trial in Cambodia, but the protests continue there. Soma and her colleagues are intent on halting all trials of tenofovir, worldwide.

Objections have focused on the study's subjects: prostitutes, usually poor, whom critics say are being taken advantage of. They cite low payments, lack of information about side effects and no health insurance should something go wrong.

In trying to get a better deal for those women, they have managed to slow the testing of what many scientists consider the best hope to stop Aids in the underdeveloped world.

Prompted by the protests, Cambodia's prime minister in 2004 cancelled the trial before a single pill was taken and threw the researchers out of the country. Trials in Cameroon and Nigeria were closed in 2005.

Researchers did not expect protests because tenofovir is so widely used in the US already. It is a licensed medication, tested and approved, and used as part of a cocktail of drugs to treat people infected with HIV. The question is whether it can work as a prophylactic drug in uninfected people.

Given the difficulties researchers have encountered in developing a real vaccine, many see tenofovir as the next best thing. So it seemed logical to conduct a large trial in a place like Cambodia, where 4-10 per cent of prostitutes are infected with HIV each year.

Soma (38) and her supporters say she is part of a grass-roots movement fighting imperialists who would use the developing world as a testing lab. However, the rally that day, one of several held throughout Asia, was organised mostly by outside activists who coordinated with each other via e-mail.

Fabrice Pilorge (39), of the Paris branch of the Aids group Act Up, which advised the protesters, said he never intended to have the trial halted, he only wanted to get better benefits for the participants.

"What we did is going to slow research," he acknowledged. "As an activist, we always want the research to be fast."

Over the past few decades, poor countries with high HIV infection rates have struck a delicate bargain with the West, opening their populations to researchers from wealthier nations.

Most of the money for the tenofovir trials, for example, comes from the US.

In return, the foreign governments seek access to the latest information about Aids.

Soma's friend Pich Sochea (38), also a leader of a prostitutes' union, was among the first to hear about the trial, at an HIV prevention workshop in the spring of 2004.

Sochea thought it sounded pretty good. The women would get paid $3 a month to take some pills - either tenofovir or a placebo - daily for a year.

A woman from a supportive NGO typed "tenofovir" into an internet search engine and started reading. Some websites listed serious potential side effects, such as kidney problems and osteoporosis.

Soma said she and her friends wondered: "If the trial is so good, why don't they get sex workers from their own country? Why are they coming to a poor country?"

The prostitutes demanded meetings with the scientists and came up with a wish list: more pay, more information and a promise of health insurance for 40 years.

Kimberly Page Shafer, an Aids researcher from the University of California and one of the lead investigators on the study, said a vaccine had to be tested in a population in which the rate of infection is high enough to provide an answer in a reasonable amount of time. A trial in the US, where infection rates are much lower, would take decades.

Page Shafer said that some of the prostitutes' concerns were being addressed: scientists planned to set up a clinic in parallel with the trial for anyone who became infected with HIV.

Long-term insurance, however, was not something typically provided in studies and would be prohibitively expensive.

Although the researchers said they were willing to negotiate, they did not move fast enough.

The anger and allegations spilled over to Hong Kong and Bangkok, where protesters threw red paint all over the booth used by Gilead Sciences Inc, the California-based manufacturer of tenofovir, at the International Aids Conference that summer.

In the autumn of 2004, Cambodian prime minister Hun Sen ordered the scientists to stop the trial.

New tests of tenofovir have recently begun in Ghana, Malawi, Botswana and Peru. To forestall controversy, the Gates Foundation is hosting a series of meetings about tenofovir, flying in activists, aid organisations and officials to its Seattle headquarters.

"We've all learned how to better communicate and it's past the point of pointing fingers," said Helene Gayle, who until recently headed the Gates Foundation's Aids efforts.

However, Mitchell Warren, executive director of the New York-based Aids Vaccine Advocacy Coalition, said he still worried about the next misunderstanding, the next rumour.

"The trials have been stigmatised as evil and that is not going to change overnight," he said.