AIDS Drug Trial Turned Away
Protests by Prostitutes in Cambodia Ended Tenofovir Testing
By Ariana Eunjung Cha
Washington Post Staff Writer
Tuesday, May 23, 2006; A10
PHNOM PENH, Cambodia -- On a Sunday afternoon in November, Yunang Soma stood shoulder-to-shoulder with other prostitutes on a makeshift stage in a park and shouted to the crowd: "The U.S. says it wants to help poor people, but it is killing the poor people!"
Soma was protesting 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 person 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. 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.
But researchers have run into a highly 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 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 canceled 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 United States 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. Some U.S. doctors are so optimistic that they have begun prescribing it to people who engage in risky behavior such as unprotected sex.
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, one of several held throughout Asia, was organized mostly by outside activists who coordinated with each other via e-mail. They even produced the T-shirt that Soma was wearing, which read in part: "People over profit."
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."
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 United States. In return, the foreign governments seek access to the latest information about AIDS -- and a lower price for the drugs should they turn out to be effective.
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, 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 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 provides office space and funding to the prostitutes. They asked Barbero to translate the papers and explain the study to them.
Barbero typed "tenofovir" into an Internet search engine and started reading. She learned that tenofovir has been long used as a therapy for people already infected with HIV. By preventing HIV from reproducing, it slows the progression of the disease. In experiments on healthy rhesus monkeys, all remained uninfected when they were deliberately exposed to the simian equivalent of HIV.
But some Web sites listed serious potential side effects, such as kidney problems and osteoporosis. Barbero pointed that out to the prostitutes.
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? Why are they coming to a poor country?"
The prostitutes 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 at San Francisco and one of the lead investigators 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. A trial in the United States, 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, Page Shafer said, is not something that is 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 fall of 2004, Cambodian Prime Minister Hun Sen ordered the scientists to stop the trial, citing concern for "human values and rights."
The negative reaction to the study was further fueled by rumors. 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); that the pills used in the study contained HIV (they contain only chemicals); and that the researchers were encouraging participants not to use condoms while they were taking the medication because they wanted the subjects taking the placebo to have a higher incidence of AIDS (the study protocol calls for researchers to encourage safe sex, including the use of condoms).
Page Shafer, who had moved to Phnom Penh with her two daughters for the study, was shocked when in August 2004 she was forced to pack up and leave. She said recently that if she has one regret, it is that she was not prepared for the level of criticism from groups outside Cambodia. "This became an international trial with international issues," she said.
As the trials were halted, AIDS activists began turning against each other. Angry that the protesters were slowing research, some attacked Womyn's Agenda for Change. "They found an opponent they could blame, which was me, the white woman Westerner who heads some organization," Barbero said.
Others characterized Act Up Paris as the prime villain. Mark Harrington, a prominent AIDS activist, said that by demanding U.S.-level benefits for penniless Cambodian sex workers, Act Up was practicing "ethical imperialism."
Pilorge, who helped organize protests in Thailand, Cambodia and Cameroon, said the protests were homegrown and, in any case, the trials should have been designed with more attention to protecting the subjects. He said scientists should have allowed the prostitutes to participate in designing the trial, which would have given them better access to information about the drug, rather than relying on the Internet and outside activists.
"In the future one of the consequences we hope will be that the trials will be more ethical, will be more well made," Pilorge said.
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 organizations 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.
But Mitchell Warren, executive director of the New York-based AIDS Vaccine Advocacy Coalition, said he still worries about the next misunderstanding, the next rumor. "The trials have been stigmatized as evil, and that is not going to change overnight," he said.