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Unethical Research: The Thai Tenofovir Trials

By: Jerry Liang


As technology advances at unprecedented rates, moral and ethical issues have been proposed. Issues include, “Should we edit our children’s genomes?”, “Should we give robots the right to kill?”, and “Should we colonize other planets?” Many countries have ethical and moral problems while practicing science. Thailand is no different.


One major Thai trial involving human subjects that was considered unethical was the tenofovir trial for HIV prophylaxis starting in the early 2000s. The tenofovir trial studied the use of tenofovir to prevent HIV spread among injecting drug users (IDUs). Half the participants would receive the tenofovir while the other half would receive the placebo drug. Thailand has always been harsh on IDUs, resulting in human rights violations and up to 3,000 extrajudicial killings. Still, Thai researchers believe it is their obligation and duty to ensure that the participants’ human rights are not abused and violated. The two main communities that had raised concern regarding this HIV trial were the Thai Drug Users Network (TDN) and the Thai AIDS Treatment Advocacy Group (TTAG). However, their objective concerns had been overlooked by the Thai government.





“Yet again, we drug users are treated as less than human, not worth the same basic dignity and rights as others. Even though the researchers know Thai IDU are at high risk for HIV, they refuse to provide clean injecting equipment in the context of this trial despite using a placebo.” - Paisan Suwannawong, Director of the Thai AIDS Treatment Action Group (TTAG).


One major problem was the lack of sterile needles and syringes for the participants. Another concern was that the government initially intended to give tenofovir to the placebo group for 1 year after the trial and the other half of participants would not receive anything. Finally, the individuals who were at the greatest risk of contraction would only receive tenofovir for only a short amount of time. Seeing this as unethical, negotiations made by researchers thereafter had ensured that all participants would receive tenofovir. However, researchers believe that all participants should receive the highest standard of care including quality referrals, support, treatment, and care.





The Government was still forcing IDUs to take part in this tenofovir trial, and IDUs who participated in this trial were often people who received methadone care. Nantapol Cheunchooklin, who was a trial participant in an earlier vaccine trial among IDU in Bangkok, remembers,


“I was afraid that if I refused being recruited in the trial, I might displease the clinic staff or that it would have a negative consequence on the methadone I was receiving.”


The HIV/AIDS community in Thailand isn't naive about the morals of clinical trials: numerous people have been directly or indirectly influenced by past AIDS trials in Thailand that have raised moral concerns. Regardless, TDN and TTAG have, from the start, made it clear that they support the improvement of tools to decrease the burden of HIV on the world population, and would like this trial to go ahead. The TDN and TTAG communities recommended the establishment of a committee, chaired by the US Centers for Disease Control and Prevention, to address key HIV prevention, treatment, and care issues in this trial. They suggested that members should comprise two TDN representatives, Thai Red Cross representatives, and government and nongovernmental representatives. From the standpoint of Science for the People Thailand, we support activism that is against the coercion of the less fortunate to do unwanted trials. However, if ethical and voluntary, we are more than supportive towards the science that stands to benefit humanity.


References

DEFINE_ME, www.thelancet.com/journals/lancet/article/PIIS0140673605665014/fulltext.

Alcorn, Keith. “Thai Tenofovir Trial Runs into Trouble after Ethics Protests from Drug Users.” Aidsmap.com, 10 Mar. 2005, www.aidsmap.com/news/mar-2005/thai-tenofovir-trial-runs-trouble-after-ethics-protests-drug-users.

Chua, Arlene, et al. “The Tenofovir Pre-Exposure Prophylaxis Trial in Thailand: Researchers Should Show More Openness in Their Engagement with the Community.” PLoS Medicine, Public Library of Science, Oct. 2005, www.ncbi.nlm.nih.gov/pmc/articles/PMC1261513/.

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