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A public statement from the Global Campaign for Microbicides and the AIDS
Vaccines Advocacy Coalition on the impact of stopping Tenofovir trials
in Cambodia and Cameroon
for Microbicides and the AIDS Vaccines Advocacy Coalition)
trials have been launched in Africa, Asia and the United States to explore
the potential use of oral Tenofovir as a "once a day" pill to
prevent HIV in uninfected individuals—an intervention known as pre-exposure
prophylaxis (PREP). Yet concerns from a few activists opposed to these
efforts have resulted in government decisions to halt the trials in Cambodia
The decisions to halt
the trials have generated a firestorm of controversy in the HIV/AIDS treatment,
prevention, advocacy, and research communities. In both countries, the
public allegations criticizing the trials were not completely evidence-based,
and the media's coverage was highly provocative. As a result, government
decisions to stop the trials may have been premature.
Left unchecked, these
forces threaten to undermine future trials. The cost is paid in people's
lives - the lives of those who might benefit from new technologies or
treatments. This is not to say that unethical research should proceed.
But derailing trials without high levels of evidence to support the claim
that they are unethical, is a costly practice.
The Global Campaign
for Microbicides and the AIDS Vaccines Advocacy Coalition (AVAC) are international
networks of advocates who have worked to forge meaningful collaborations
between researchers, communities and activists. Both organizations are
committed to ensuring that as science proceeds, the public interest is
protected and the rights and interests of trial participants, users, and
communities are fully represented and respected. Good prevention research
must be accelerated, must be ethical, must involve communities and must
result in products accessible and acceptable to the people who need them
We are convinced that
the concerns raised by those who oppose the trials are solvable and need
not have resulted in stopping trials. Issues can and should be addressed
by researchers and sponsors working collaboratively with local communities
and governments. Controversy over the ethics of research is an opportunity
to engage communities in partnership. As Gregg Gonsalves of Gay Men's
Health Crisis recently noted, shutting down an HIV prevention study "is
not a victory - it is a defeat. A victory would have been to be able to
craft a solution to fix the local study."
In this spirit, the
Global Campaign and AVAC are planning to generate various materials that
accurately reflect current events, assist all stakeholders with working
though these issues and provide specific recommendations to accelerate
ethical development of new technologies. Among the materials we will produce
- A fact-sheet designed
to correct some of the common misperceptions and errors of fact that
have been made in the course of public discussion of these trials. This
fact sheet will be available on our websites
in the next few weeks.
- A background document
that attempts to articulate the basics about Tenofovir, the current
PREP studies and the various issues involved will be available in early
- Two on-the-ground
case studies to document what actually happened in Cambodia and Cameroon
from each sector's perspective, to identify lessons learned that could
help prevent similar situations in the future. This project is already
underway, and we hope to have these materials available in the coming
The following key
principles are pivotal:
- The HIV pandemic
creates an incredibly urgent demand for additional safe and effective
tools with which to treat HIV infection and stop transmission. This
can only be achieved by responsible, credible scientific studies.
- Research to create
these tools must be done in a way that protects the rights of vulnerable
populations and contributes to overcoming the global imbalance in access
to health care resources.
- Communities affected
by research must be actively involved in its conceptualization and implementation.
- The rights of trial
participants should be respected and participants should be admired
for their contribution to helping others.
- Researchers and
funding agencies must be held accountable for their studies, and advocates
must demand that problems be resolved.
AVAC and the Global
Campaign are dedicated to developing effective collaborations among a
broad range of civil society actors, researchers and sponsors.
We cannot combat AIDS
effectively without research and development of new technologies. Without
clinical trials, we cannot know what does and does not work - or how different
drugs and interventions work in various populations and settings. This
means wrestling, collectively and collaboratively, with the complexities
of designing trials that are simultaneously ethical and scientifically
rigorous. Simply objecting to existing trial designs and shutting down
trials is not a solution. We must, instead, proceed with the much harder
job of shaping a research standard we can support and then demanding that
trials be designed and adequately funded to meet that standard.
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