The Slippery Ethics of Third World Drug Trials

Seated at a rickety food and drinks stall at the edge of a strip of wooden houses near Phnom Penh’s railway station, Sithi Rata­na, 21, speaks with a certain authority about HIV and AIDS.

A beer girl by night and a HIV/AIDS educator to local sex workers by day, Sithi Ratana is primary health care in its truest sense in this squatter village.

Sithi Ratana also knows more than most of her peers about the first clinical trials of the HIV drug tenofovir, a once-a-day tablet that will be tested in Cambodia to determine whether it can protect people from contracting the killer virus.

She has attended at least two meetings on the drug trials with staff from the National Center for HIV/AIDS, Dermatology and Sexually Transmitted Infections, but what she knew was at best wrong, and at worst dangerous.

Searching through her house, Sithi Ratana retrieved some jotted notes and explained the tests.

Some 960 sex workers who are free of HIV are needed to participate in the voluntary drug trials. With HIV infection rates at almost 30 percent for Cambodian sex workers, they have been judged an excellent test group for the study.

The only real drawback to the trials was the slim chance of some side-effects: Nausea, vomiting, diarrhea and possibly liver and kidney damage, she said.

Sithi Ratana seemed well informed until she began to ex­plain that condoms could prevent liver and kidney problems and that a cure for AIDS had already been found.

“If [the volunteers] use condoms during the trials they would not get kidney and liver damage,” she said.

More importantly, she said that sex workers in another country had proven that after taking the drug they “could become free of AIDS.”

Her confusion exemplified concern expressed last month by Dr Sin Somuny, executive director of the medical NGO Medicam, who warned that gaining the “in­formed consent” of sex workers, a vulnerable and generally poorly educated group, may prove a considerable challenge for research­ers.

He is not alone in his concerns. The Women’s Net­work for Unity, a sex workers’ union that claims 5,000 members, has been lobbying to boycott the tests, scheduled to start in July, until researchers agree to provide 30-year health insurance coverage against possible side effects.

The sex workers claim the trials do not balance the potential threat to their health with the benefits to the medical world and, no less, the multibillion-dollar pharmaceutical industry.

Tenofovir is currently used in combination with other antiretroviral drugs as a treatment for those already infected with HIV. Tests on long tailed macaques in 1995 showed tenofovir, when administered to the monkeys before their exposure to the simian variant of HIV, could prevent the disease from taking hold.

The US National Institute of Allergies and Infectious Diseases has allocated some $1.7 million for the University of California-San Francisco to take part in the Cambodia trials.

Through his Bill and Melinda Gates Foundation, Microsoft tycoon Bill Gates has given $6.5 million for planned tests in four African countries and for the tests in Cambodia. The money was disbursed through the Family Health International NGO for the research in Cambodia to be conducted by the University of New South Wales, Australia.

With around 45 million people infected worldwide with HIV and some 5 million new HIV cases in 2002 alone, a pill that could protect against the virus would likely have world-changing consequences.

But sex workers want to know what they will get in return for their role in possibly making medical history.

“Cambodian women are not …monkeys,” said Network secretariat member Sou Sotheavy to enthusiastic applause at a meeting last month of some 120 sex workers in Phnom Penh to voice their resistance to the trials.

“I do not pressure or oppose you joining the trial. We just ask for a 20- to 30-year health guarantee,” said Sou Sotheavy, a transgender 64-year-old who likes to be called she.

Cheers greeted another wo­man who remarked that the pill was “only tested on monkeys before Cambodians.”

Taking the controversy in stride is the trial’s principle investigator, Dr Kimberly Page Shafer, associate professor at the Center for AIDS Prevention Studies, Univer­sity of California-San Francisco.

“I’m not surprised but I think it is one sex worker group and there are many in Cambodia,” said Dr Page Shafer, who stressed that the tests met the most rigorous regulatory standards.

“It is important to print that we will provide medical care for participants in this trial,” she said. But providing a 30-year health plan would probably be unethical, she added.

“Medical ethicists, in fact, will point out that offering a 30-year safety policy can be construed as undue inducement to participate in a trial,” she said.

Participants are guaranteed regular medical checks, and if harmed, they will be referred to local services or organizations that will provide care. Those who contract HIV will be given free treatment.

Hardly a promising offer, critics claim, given the quality of medical care available in Cambodia.

In the US Food and Drug Ad­min­i­stration’s approval of tenofovir, whose trade name is Viread, in 2001, it was noted that lactic acidosis and hepatomegaly with steatosis—severe liver enlargement and excess fat in the liver—“are severe and possibly fatal conditions.”

Those conditions are not generally considered a side effect of tenofovir, although they have been associated with other antiretroviral agents, said John Kaldor, professor of epidemiology at the University of New South Wales, Australia.

Also defending tenofovir’s safety record, Page Shafer made it clear that she didn’t believe the network was the sole driving force behind the insurance demands and implied that one should look to Oxfam Hong Kong, which supports the Network, for answers.

Rosanna Barbero, coordinator of Oxfam Hong Kong, however, denied her organization was behind the sex workers’ demands.

If medical trials are conducted in the West there are ways to seek redress, Barbero said. “But in Cambodia, we know that these mechanisms are not there.”

Another ethical minefield is the issue of HIV and those who believe the trial implicitly rests on the volunteers being exposed to the virus at some stage during the yearlong study.

“What is the use of the test when we participate with condoms?” asked Keo Tha, 40, also a member of the Network’s secretariat.

Keo Tha said she believed re­search­ers were trying to profit from the vulnerability and naiv­e­te of some prostitutes, who may not always be able to convince their clients to use a condom.

And when re­ports circulate that a drug is being tested that might prevent HIV infection, sex workers might find it even more difficult to convince their partners to use condoms.

Page Shafer denies this: “All the women will be informed that the efficacy of this drug is unknown, and it is especially important to be protected against HIV.”

If tenofovir proves successful, Cambodian volunteers will receive a free two-year supply of the pills and Cambodia will be able to purchase the pill at reduced prices, putting the daily dose at around $1.

Though a bargain compared to the developed world, the cost may still be out of the reach for many Cambodians, where more than 40 percent of the population lives on less than $1 per day.

As Oxfam’s Barbero said: “They can’t even afford paracetamol now.”

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