E-DRUG: Lancet: Unethical clinical trials in Thailand: a community response
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Two letters in the correspondence section of this week's Lancet.
[Copied as fair use. BS]
contributed by
Nathan Ford
MSF London
"Nathan Ford" <nathan.ford@london.msf.org>
1. Unethical clinical trials in Thailand: a community response
The Lancet 6 May 2005; 365:1617-1618
Seree Jintarkanon (a), Supatra Nakapiew (b), Nimit Tienudom (c), Paisan Suwannawong (d) and David Wilson (e)
Concerns over the tenofovir trial in Thailand are far more profound than your Mar 26 Editorial suggests.1
The Helsinki Declaration states that placebo-controlled trials should only be used in the absence of proven prophylactic, diagnostic, and therapeutic methods. The tenofovir trial studies the use of tenofovir to prevent HIV spread associated with injecting drug use (IDU). Half the participants will receive tenofovir and half placebo. None will receive the most effective prevention tool that currently exists: clean needles and syringes. There is no law in Thailand opposing distribution of injecting equipment. The fact that the trial sponsor-the US government-opposes distribution of injecting equipment does not alter this ethical requirement.
The Thai government takes a hard line against drug users, leading in the past to widespread human rights abuses2 and up to 3000 extrajudicial killings. At the Bangkok AIDS conference in July, 2004, the government's position shifted towards favouring harm reduction, but drug users in Thailand remain a highly vulnerable group. Researchers have an obligation to ensure that participants are protected against human rights abuses.
Benefits to study participants fall short of ethical requirements. The sponsors initially planned to give tenofovir to the placebo group for 1 year after the trial: half the trial participants would receive nothing, and those placed at greatest risk of infection would receive the drug only for short-term use. Subsequent negotiations have ensured that all participants will receive tenofovir, but this needs to go further: all participants should receive the highest standard of care including quality referrals, support, treatment, and care.
Underlying these issues is the most profound problem with this trial: the lack of proper community involvement in its design. The IDU community in Thailand is not invisible: the Thai Drug Users Network has been in existence since 2002 and includes more than 120 members. But this group was not consulted at any stage.
According to the US Centers for Disease Control and Prevention, a community advisory board is planned, but only after the final protocol has been approved by three ethics committees. This would preclude community input in the study design and give little possibility for influencing the final protocol in any significant way.
The IDU community would like to support this trial. But community involvement must be a partnership based on reciprocity, not an a posteriori response to bad publicity. Many in the IDU community in Thailand have legitimate concerns about the trial design and location, and are affronted that these concerns3 have been ignored. As a result, dialogue between the two sides has broken down.
This is not the first time HIV trials in Thailand have raised concerns from the community.4 Calls have previously been made for an institutional mechanism that would systematically ensure community participation,5 and steps have recently been taken to establish such a mechanism under the stewardship of the Thai Red Cross. A rigorous, standardised consultation process is the only way to ensure that trial participants in poorer countries are included as partners in international research. The tenofovir trial illustrates once again how urgently such a mechanism is needed.
We declare that we have no conflict of interest.
References
1. The Lancet. The trials of tenofovir trials. Lancet 2005; 365: 1111. Full Text | PDF (31 KB) | CrossRef
2. Human Rights Watch. Not enough graves: Thailand's war on drugs, HIV/AIDS and violations of human rights. Human Rights Watch 2004; New York
3. Sakboon M. Between the lines: ethical practices must be held foremost in drug trials. Nation Dec 11 2004;
4. Suwanjandee J, Wilson D. Helsinki Declaration and Thailand. Lancet 1999; 354: 343. Full Text | PDF (27 KB) | MEDLINE | CrossRef
5. Wilson D. North-South research in developing countries must respond to community's priorities. BMJ 1999; 319: 1496. MEDLINE
Affiliations
a Thai Drug Users Network, Bangkok, Thailand
b Centre for AIDS Rights, Bangkok, Thailand
c Aids Access Foundation, Bangkok, Thailand
d Thai AIDS Treatment Action Group, Bangkok, Thailand
e Medecins Sans Frontieres, 522 Mooban Nakorn Thai 14, Ladphrao Soi 101/1, Bangkok 10240, Thailand
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2. Unethical clinical trials in Thailand: a community response
The Lancet 6 May 2005; 365: 1618-1619
Bebe Loff a b , Carol Jenkins b, Melissa Ditmore b, Cheryl Overs b and Rosanna Barbero b
See Editorial
On March 4, 2005, the Women's Network for Unity, a grassroots representative collective of sex workers based in Phnom Penh, Cambodia, wrote to Prime Minister Hun Sen about the tenofovir trials1 in which they were to be recruited, stating: "Cambodian people are not waste and Cambodia is not waste bin!"
The Network has about 5000 members in 13 provinces and cities in Cambodia, yet was not consulted about the planning or implementation of the trial. The letter continues: "There are some NGOs still pushing women to participate in the unethical trial. Those people only think about their own benefit, not ours. They have not provided information and documents related to the trial to us . What worries us the most is that the research group does not have a clear ethics protocol for this clinical trial. They are pushing us to do what they think is right and take no concern about our lives."
It is worthy of note that there has been a reduction of new HIV cases for several years, attributed largely to the rising use of condoms in commercial sex.2 However, sex workers' powerlessness and consequent vulnerability to HIV is made worse in Phnom Penh where almost all sex workers are raped, usually by police or gangsters who act with impunity because sex workers have no recourse to a justice system. They are treated as non-citizens, without choice or rights. This is exemplified at times by the 100% Condom Use Programme which further deprives workers of control over their working environments.3 This reality, coupled with the nation's lack of quality medical services, makes current and future promises of medical treatment and negotiations for access to cheap tenofovir sound distressingly empty.
Duan has advocated a consumer model to counter barriers to participation in HIV vaccine trials.4 Sex workers, who have been subject to research for a couple of centuries with little discernable benefit to them, and often harm, would prefer not to be regarded as consumers of a research package. Sex workers have voices, as individuals and through groups formed to speak on their behalf, and expect to be part of the decision-making process about what research is done using their bodies, the design and implementation of this research, and subsequent follow-up. In the process carried out by researchers funded by the US National Institutes of Health, they were neither placed on the community advisory boards nor directly addressed about their concerns until after they had made such a fuss that the Prime Minister was forced to intervene.
Most generously, sex workers (and their advocates) have indicated their willingness to continue involvement in trials, but a great deal must change before researchers are worthy of their confidence. A political and social environment that undermines their status as human beings, and threatens their lives and wellbeing, must be relevant considerations when making decisions about research. And they must be party to this decision-making process from the earliest stages.
As people living at the margins, sex workers rarely have access to respectful treatment and thus are unlikely to derive benefits from the results of a trial in the long term-even were these to be promised. At the very least, they and their representatives should be treated with respect and their contributions acknowledged in the context of research in which their very vulnerability makes them "ideal" participants.
We thank Andrew Hunter for his contribution to this letter.
We declare that we have no conflict of interest.
References
1. The Lancet. The trials of tenofovir trials. Lancet 2005; 365: 1111. Full Text | PDF (31 KB) | CrossRef
2. Vonthanak Saphonn, Heng Sopheab, Ly Penh Sun, et al. Current HIV/AIDS/STI epidemic: intervention programs in Cambodia, 1993-2003. AIDS Educ Prevent 2004; 16: 64-77
3. Lowe D. Documenting the experiences of sex workers: perceptions of the Cambodian 100% Condom Use Program. Phnom Penh: Policy Project, 2003.
4. Duan D. Listening to consumers and HIV vaccine preparedness. Lancet 2005; 365: 1119-1121. Full Text | PDF (51 KB) | CrossRef
Affiliations
a Department of Epidemiology and Preventive Medicine, Monash University, Alfred Hospital, Melbourne, Victoria 3004, Australia
b Network of Sex Work Projects, Hong Kong