Important note: Information in this article was accurate in 2005. The state of the art may have changed since the publication date.
Bangkok Post - March 11, 2005
Apiradee Treerutkuarkul
They have raised questions about the trial's safety and transparency, and possible human rights violations.
Several advocacy groups, including the Aids Access Foundation and the Network of People Living with HIV/Aids in Thailand, said the plan did not give them a chance to show their position.
"We can't accept this drug trial. Authorities do not allow people living with HIV/Aids to get involved in project planning or learn about pros and cons even though we have a right to do so," said Nimit Tienudom, the foundation leader.
The project was approved by the Public Health Ministry's ethical review committee for human research in late February. However, it did not give clear explanations about the safety of the trial or benefits for volunteers, he said.
The Tenofovir study will be sponsored by the United States Centres for Disease Control and Prevention, the Bangkok Metropolitan Administration, with pharmaceutical support from Gilead Sciences. The trial aims to recruit 1,600 intravenous drug users treated at 17 rehabilitation centres in Bangkok to study how well the drug works.
The Cambodian government recently suspended a drug trial among commercial sex workers because they were not advised about their risk of infection and were unlikely to tell their clients to use condoms.
Seree Jintakanont, a representative of the Thai-Drug Users Network, said he was concerned about the safety of intravenous drug users getting treatment from Bangkok rehabilitation centres. They might be pressured to quit drugs to be eligible for health care services, but Thailand needed a reliable harm reduction programme to provide them with methodone for detoxification.
It is still unclear whether volunteers would get information about the most effective prevention tools from the placebo-involved study. Unlike vaccine studies, volunteers have a right to receive real medication according to the Declaration of Helsinki which emphasises the importance of care in studies involving a placebo-controlled trial. The use of placebos is prohibited in the US and many developed countries, he said.
Tenofovir is being tested in multiple sites around the world, including the US. Participants will be offered a prevention package including condoms. However, he said intravenous drug users should also be equipped with other tools that have been proved to be effective in reducing infections - clean needles and syringes.
Mr Seree asked researchers to opt for a comprehensive harm reduction approach and ensure the same quality of referrals, support, treatment and care that trial participants would get through the public health care system.
Suphatra Nakapiew, director of the Human Rights on Aids Protection Centre, asked how participants in the trial would gain access to the drug after the trial. Benefits that Thailand would receive should be taken into account before conducting the trial, she said.
"Community participation should be treated as an essential element of any clinical study. Drug-users, NGOs and activists should be involved from the outset on any official committee, not just as public participants who join after all the protocols have been accepted," she said.
Khachit Choopanya, the principal investigator of the Bangkok Tenofovir study, insisted the study process had already been set up. The trial would be held in April as planned so Aids and HIV-infected people would get the benefits of the drug as soon as possible.
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