Biomedical Research in Developing Countries - UNICRI

The Botswana study was terminated and volunteering participants were transferred
to another study submitted in 2007 as a tenofovir/emtricitabine safety-efficacy
PrEP study.
The concerns of the activists in all the tenofovir trials were mostly related to the
protection of those participants who became positive to the HIV virus during the
trials and whether they would have access to the state of the art antiretroviral
therapy if and when needed. In addition, as prescribed by the DoH, the use of
placebo against tenofovir did not represent the provision of the best prophylactic
intervention available. In the case of the studies that involved female prostitutes (as
in Nigeria and Cameroon) for example, the best prophylactic intervention would
have been, next to adequate safe sex education and counselling, at least the
provision of female condoms, in addition to male condoms, given the already little
influence women prostitutes are likely to have on their clients regarding the use of
condoms 42 . Being the primary endpoint of the study the number of new infections,
it is difficult in these conditions not to see a conflict of interest between the
investigators’ necessity to meet their primary endpoint data and the need to protect
and safeguard the human rights and health of participants.
According to Singh and Mills, “the rapidly collapsing tenofovir trial network shows
that a lack of communication between activists, participants, and researchers can
lead to suspicion, speculation, and, ultimately, damaging outcomes” 43 . The authors
propose that also in the field of medical research the strategy of “preventative
diplomacy” should be applied, where a conflict is kept from worsening by
addressing it before or as it emerges, rather than when it has already escalated. In
this type of conflict resolution mechanism, it is important to maintain a proactive
strategy, not a reactive one, when dealing with relevant constituencies. In this way
the concept of “collaborative partnership” would not remain just abstract theory
but would be seen in action, and find its real application in the constructive
involvement of all stakeholders groups, the investigator and the sponsor, in the
decision making process, in addressing mutual interests and concerns and in the
sharing of responsibilities along the way. Among the instruments that may be used
to prevent the trial suspension due to escalating conflicts the authors include the
establishment of early warning mechanisms (such as a community liaison officer),
fact finding missions, confidence-building measures, such as the inclusion of
activist groups in community advisory boards, engaging the media, education
(particularly on important issues such as therapeutic misconception, compensation
for study-related injuries, and post-trial benefits). According to the authors, the
ultimate goal for all the people involved in the tenofovir trials was and still is to find
an effective preventative agent against HIV infection. To this end, an effort is
necessary in this situation where all stakeholders raise above particular interests and
42 Nigeria: Trial of tenofovir as a prophylactic against HIV suspended, IRIN, Humanitarian News and Analysis, UN
Office for the Coordination of Humanitarian Affairs
http://www.irinnews.org/Report.aspx?ReportId=53630 (accessed October 2008)
43 Singh JA, Mills EJ., The Abandoned Trials of Pre-Exposure Prophylaxis for HIV: What Went Wrong?, PLoS Med,
2005, Vol. 2, No. 9: e234
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