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The Tenofovir pre-exposure prophylaxis trial in Thailand: researchers should show more openness in their engagement with the community
Posted by plosmedicine on 30 Mar 2009 at 23:45 GMT
Author: Arlene Chua
Position: No occupation was given
Institution: Medecins Sans Frontieres, 522 Nakorn Thai 14, Ladphrao 101/1, Bangkapi, Bangkok, Thailand
Additional Authors: Nathan Ford, David Wilson, Paul Cawthorne
Submitted Date: August 24, 2005
Published Date: August 26, 2005
This comment was originally posted as a “Reader Response” on the publication date indicated above. All Reader Responses are now available as comments.
Two recent articles in Plos Medicine , criticize the role played by activists in raising concerns about the Tenofovir trial for HIV prophylaxis. We fully support the fact that activism should be based on informed opinion, rather than speculation, unwarranted criticism, overreaction or sensationalising facts, and believe that in Thailand the concerns raised by activists are entirely legitimate.
The key community groups that have expressed concerns about the Tenofovir trial in Thailand are the Thai Drug User's Network (TDN) and the Thai AIDS Treatment Advocacy Group (TTAG), which are described in the Appendix to this letter. These groups, which can justifiably claim to represent Thai drug users, are well informed about the trial, but their objective concerns have been ignored by the trial investigators. Contrary to the assertion of Joep Lange, that the investigators did consult intensely with community groups concerned, TDN and TTAG were not consulted about the trial design and conduct until a very late stage, after several attempts to engage with the investigators had been rebutted. TDN and TTAG had attempted to constructively engage with the investigators since October 2004; they confined their statements of concern to private letters and meetings with the investigators, until the matter was made public in a Lancet editorial in March 2005.
One major concern about the trial relates to the failure to provide sterile needles and syringes. Singh and Mills assert that this is consistent with Thai government policy. Long prison terms and death sentences are the norm for drug-related offences and Thai police, who have wide discretionary powers, still occasionally use possession of needles as evidence to arrest suspected drug users. Thus, although needles and syringes are available over the counter from most retail pharmacies, IDU are afraid to purchase them and indeed are often afraid to use services known to be provided for drug users. There is, however, no law or policy forbidding the distribution of clean needles and syringes and preventing the investigators from doing so.
In fact, the situation in Thailand is improving, with the National Harm Reduction Working Group, chaired by The Ministry of Public Health, taking steps to increase activities in this domain. In 2004, at the 15th World AIDS Conference in Thailand, the Prime Minister said, We are now implementing a harm reduction program to reduce the risk of HIV infection among injecting drug users the program will be conducted through concerted collaboration among solo UN agencies, government bodies and non-governmental organizations including the Drug User Network.
The reason clean injecting materials are not distributed within the trial is because the US government, which sponsors the trial, bans federally funded organisations (which includes the Centers for Disease Control who are overseeing the trial) from supporting needle and syringe exchange.
Irrespective of whether a needle exchange exists in Thailand, or what the policies of the trial funders are regarding needles and syringes, Investigators have a duty to respect the Helsinki Declaration requirement that benefits, risks, burdens and effectiveness of a new method should be tested against those of the best current prophylactic, diagnostic and therapeutic methods.
The HIV/AIDS community in Thailand is not nave about the ethics of clinical trials: many have been directly or indirectly affected by previous AIDS drug trials in Thailand which have raised ethical concerns. Nevertheless TDN and TTAG have from the beginning made it clear that they support the development of innovative prevention tools to reduce the burden of global HIV and would like this trial to go ahead.
We believe that the disagreements surrounding the trial in Thailand would have been avoided if the investigators had set out to engage the community more openly and that the wealth of established knowledge among community members could have contributed enormously to the success of the trial design and implementation. TDN and TTAG have made recommendations (see Appendix) that represent a constructive way for this trial to move forward. Mechanisms that ensure systematic involvement of legitimate representatives of the affected community as partners in research is the only way to ensure that future trials will proceed in a more productive way.
Community groups representing IDU in Thailand
The Thai Drug Users' Network (TDN), Thailand's only users' group, was established in December 2002 in response to the health and human crisis facing drug users in Thailand, particularly injectors. TDN's mission is to promote the basic human rights of people who use drugs, in order for them to be able to live with dignity in society. TDN undertakes peer driven HIV prevention, care and support for IDU, has supported the Thai government National Harm Reduction Working Group's activities, and has provided technical input to UNODC and WHO consultations. Projects are implemented jointly with other organizations and include 'Preventing HIV and Increasing Care and Support for IDU in Thailand' funded by the Global Fund to Fight AIDS, TB and Malaria (GFATM).
The Thai AIDS Treatment Action Group (TTAG) was founded in December 2002 by the founding chairman of the Thai Network of People Living with HIV/AIDS (PLHA) in order to promote leadership and advocacy capacity among PLHA. TTAG's mission is to promote equal access to AIDS prevention and treatment for all through policy advocacy, coalition building and strengthening the capacity of PLHA to advocate for their human rights. Projects include 'Preventing HIV and Increasing Care and Support for IDU in Thailand' funded by GFATM, and the Mekong Region Treatment Preparedness Initiative.
Key objections of TDN and TTAG to the Tenofovir pre-exposure prophylaxis trial in Thailand in its present form:
1. Absence of community consultation during the trial design and lack of meaningful consultation in its implementation
2. Best current prophylactic methods unavailable to trial participants
3. No commitment by trial sponsors to promote the safety of trial participants when accessing services
4. No commitment by the researchers to work, after the trial, with the Thai Ministry of Public Health towards price reductions of Tenofovir
1. Urgently establish a committee, chaired by the US CDC to address key HIV prevention, treatment and care issues for Bangkok IDU in the context of the trial. Members to include 2 TDN representatives, Thai Red Cross, government and non-governmental representatives.
2. Involve TDN in trial outreach and education, including curriculum development.
3. Develop partnerships to ensure the safety of trial participants when accessing services; for example the Bangkok Metropolitan Authority should host police training workshops on harm reduction. TDN should be involved in these activities.
4. Commit to supporting TDN in efforts to ensure at least 2 years of post-trial tenofovir post-trial to trial participants and to working with the Thai Ministry of Public Health towards price reductions
1. Singh J, Mills E. The abandoned trials of pre-exposure prophylaxis for HIV: what went wrong? Plos Medicine September 2005. 2;9.
2. Lange J. We must not let protestors derail trials of pre-exposure prophylaxis for HIV. Plos Medicine September 2005. 2;9.
3. Singh J, Mills E. The abandoned trials of pre-exposure prophylaxis for HIV: what went wrong? Plos Medicine September 2005. 2;9.
4. Lange J. We must not let protestors derail trials of pre-exposure prophylaxis for HIV. Plos Medicine September 2005. 2;9.
5. Anon. The trials of tenofovir trials. Lancet 2005. 365;9465:1111
6. Thailand. Not Enough Graves: The War on Drugs, HIV/AIDS, and Violations of Human Rights. Human Rights Watch New York, June 2004. Vol. 16, 8 http://www.hrw.org/report... accessed 22 August 2005
7. Prime Minister Thaksin Shinawatra. Opening address at the 15th International AIDS Conference. Bangkok, Thailand. July 11, 2004. http://www.unaids.org/ban... accessed 22 August 2005
8. Jintarkanon S, Nakapiew S, Tienudom N, Suwannawong P, Wilson D. Unethical clinical trials in Thailand: a community response. Lancet 367 2005. 1617-8.
9. Suwanjandee J and Wilson D. Helsinki Declaration and Thailand (letter) Lancet 1999; 354: 343
10.Wilson D. North-South research in developing countries must respond to community's priorities (letter) BMJ 1999; 319: 1496x