The Nation, 11 December 2004

BETWEEN THE LINES: Ethical practices must be held foremost in drug trials

By MUKDAWAN SAKBOON

The planned trials of the anti-Aids drug Tenofovir, for which recruitment of
study subjects is due to commence early next year, should be treated with great
care. Researchers should ensure that all processes are transparent and all
ethical considerations respected.

The drug, produced by California-based Gilead Sciences, was the subject of
controversial debates recently, not because of the nature of the drug itself but
because of the procedures drawn up for the trials. Recently the Cambodian
government rejected trials of the drug among commercial sex workers.

During the 15th World Aids Conference in Bangkok in July, activists protested at
the planned Cambodian Tenofovir study. The issue of unethical practices was
raised as activists complained that sex workers who participated in the trial
would not be advised to be aware of their risk of infection and thus were
unlikely to tell their clients to use condoms.

In Thailand, the planned "Study of the safety and efficacy of daily Tenofovir to
prevent HIV infection among injecting drug-users in Bangkok," (the Bangkok
Tenofovir Study) will be sponsored by the United States Centre for Disease
Control and Prevention, in partnership with the Ministry of Public Health and
with pharmaceutical support from Gilead Sciences.

Pending approval from three ethical review boards, the study aims to enrol 1,600
drug-users to test the efficacy of the drug in preventing the spread of HIV
through intravenous drug use.

Like studies before it, the trial has prompted concern among anti-Aids advocates
and human-rights activists because the subjects of study, injecting drug-users,
are often marginalised in Thai society. For researchers, this group is an easy
target for any kind of drug study. Indeed, researchers know full well the power
they have over drug-users, who might feel compelled to enrol if they are to
receive services. Drug-users are also vulnerable to studies that pay scant
attention to ethical considerations, not to mention the negative attitudes held
against them by officials and researchers, as has been witnessed before trails
of anti-Aids vaccines carried out by the Bangkok Metropolitan Administration.

HIV-positive injecting drug-users may be pressured to quit drugs in order to be
eligible for healthcare services, including anti-retroviral therapy. Activists
call this a form of discrimination in the healthcare setting. While there is no
evidence-based policy to maintain methadone, which is primarily provided for
detoxification programmes, poor outreach has been severely compromised by the
dangerous legal and political environment, according to rights activists.

In addition, they say, drug-treatment programmes, which primarily promote
abstinence, eschewing scientific- and therapeutic-based approaches, have put
injecting drug-users at increased risk of HIV infection in pre-trial detention
and prison.

The concerns raised by non-governmental organisations, including the Thai
Drug-Users' Network, the Thai Aids Treatment Action Group (TTAG), the Thai NGO
Coalition on Aids (TNCA), MSF-Belgium/Thailand and the Centre for Aids Rights,
about possible unethical or substandard measures in testing should therefore be
taken into consideration.

The fact that the study will involve a placebo is an area of concern. Activists
have pointed to the provision in the international convention, the Declaration
of Helsinki, which emphasises the importance of care in studies involving a
placebo-controlled trial. Indeed in many industrialised countries, including the
US, the use of placebos is prohibited if proven prophylactic, diagnostic and
therapeutic methods exist.

Whether injecting drug-users who participate in the trial will receive
information about the most effective prevention tools remains unclear.

Tenofovir is being tested in multiple sites around the world, including the US.
Participants will be offered prevention package including condoms. However,
injecting drug-users should also be equipped with other tools that have been
proved to be effective in the reduction of infections , clean needles and
syringes.

Indeed, to match the government's pledge to support harm reduction and the
active involvement of drug-users, researchers should embrace a comprehensive
harm-reduction approach in this kind of study and in the standards of care for
injecting drug-users.

Researchers on the Tenofovir study need to ensure that the quality of referrals,
support, treatment and care that the trial participants will receive through the
public healthcare system are guaranteed.

Another issue of concern is how the participants in the trial will gain access
to the drug after the trial. This issue must be clearly identified in the study
protocol. Who should have access to the drug is another vital issue to consider,
as well as the negotiated price of the drug that Thailand, as a host country,
should benefit from.

Community involvement meanwhile should be treated as an essential element of the
study. Representatives of drug-users, NGOs and activists should be involved from
the outset on any official committee and not just as part of a community
advisory board normally set up after all protocols have been accepted.

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A cross posting from HIV-News-AsiaPacific@...
[hiv-news-asiapacific] No 415 – China, Thailand and Vietnam (14 December 2004)