Prostitutes' protests end Cambodia test

PHNOM PENH, Cambodia — In November, Yunang Soma stood with other prostitutes on a makeshift stage and shouted to a crowd: "The U.S. says it wants to help poor people, but it is killing the poor people!"

Soma was protesting a trial of tenofovir, which scientists think could serve as an effective "chemical vaccine" against the human immunodeficiency virus (HIV), which causes AIDS.

Unlike true vaccines, which give a person lasting immunity, tenofovir is a daily pill. Scientists hope it will protect against infection for a few hours or maybe a few days.

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

But researchers have run into an organized 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, who 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 slowed 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 canceled the trial 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 United States. It is a licensed medication, tested and approved, and used 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.

Stopping AIDS


Twenty-five years after AIDS was identified, the medical community still is struggling to figure out how to prevent the virus from infecting people. Here are some of the most promising approaches:

The theory

Vaccines: Vaccines contain parts of viruses (killed or weakened) that trick the body into thinking it has an infection, prompting the production of antibodies and other immune responses that ward off future exposure.

Tenofovir: The drug was approved by the Food and Drug Administration (FDA) to treat HIV-positive patients in 2001; it slows the progress of the disease by preventing HIV from reproducing in uninfected cells. Scientists hope that by giving the pills to healthy people they can prevent them from becoming infected.

Microbicides: Microbicide applies to a broad range of gels, creams, films and other products with an active ingredient that can act as a "barrier" to prevent infection.

Status

Vaccines: The world's first large-scale clinical trial of an AIDS vaccine, developed by VaxGen of California, ended in 2003, when the vaccine was found to be ineffective. Another trial, using that vaccine in combination with another developed by Sanofi Pasteur of France is ongoing and involves 16,000 people in Thailand. Results are not expected for three more years. Roughly 36 other vaccines are in smaller-scale human trials.

Tenofovir: In large-scale trials throughout the world, including Ghana, Peru, Botswana, Thailand and the United States.

Microbicides: Among the largest is a trial in several countries in southern Africa that tests a gel on women.

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So it seemed logical to conduct a large trial in a place like Cambodia, where 4 to 10 percent of prostitutes are infected with HIV each year.

Soma and her supporters say she is part of a grass-roots movement fighting imperialists who would use the developing world as a testing lab. But the rally that day was organized mostly by outside activists.

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 said 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."

Soma's friend Pich Sochea, 38, who with Soma is a leader of a prostitutes union, was among the first to hear about the trial. The women would get paid $3 a month to take some pills — either 300 milligrams of tenofovir or a placebo — daily for a year.

Sochea took some informational papers, which were in English, to Rosanna Barbero, an Australian who ran Womyn's Agenda for Change, a group that advocates the empowerment of Cambodian women. They asked Barbero to translate the papers and explain the study.

Barbero learned tenofovir has been long used as a therapy for people infected with HIV. By preventing HIV from reproducing, it slows progression of the disease. But she also learned of potential side effects, such as kidney problems and osteoporosis. Barbero pointed that out.

Soma, 38, said she and her friends wondered: "If the trial is so good, why don't they get sex workers from their own country?"

The women demanded meetings with the scientists. Working with Barbero and her staff, they 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, San Francisco, and a lead investigator on the study, said a vaccine has 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.

Although the researchers said they were willing to negotiate, they did not move fast enough. In fall 2004, Cambodian Prime Minister Hun Sen ordered scientists to stop the trial.

The negative reaction to the study was further fueled by rumors. Among other things, people said that the drug was so dangerous, it wasn't being tested in the United States (tenofovir is being tested on a small scale in uninfected gay men in San Francisco and Atlanta) and that the pills used in the study contained HIV (they contain only chemicals).

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, flying in activists, people from aid organizations and officials to its Seattle headquarters.

"We've all learned how to better communicate," said Helene Gayle, who until recently headed the foundation's AIDS efforts.