AIDS Drug Trial Turned Away
Tuesday, May 23, 2006
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.