Anti-AIDS Cream's Failure Has Silver Lining
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From: Global Campaign for Microbicides
Dear Friends and Partners of the Global Campaign for Microbicides, The Population Council, an international non-profit research institution, has just posted the results of their Phase 3 large-scale effectiveness trial of Carraguard®, a microbicide candidate developed as an odorless, clear gel made from carrageenan, a seaweed derivative.
New drug development is always a long-term struggle. Typically hundreds of product leads fail for every one that succeeds. Still, this news produces understandable disappointment, especially for people in areas heavily impacted by the HIV pandemic. Thousands of South African women volunteered to test this product, hoping that it might be a new prevention tool. Those women have our deepest thanks for the highly personal contribution each one made to advancing this research - as do the researchers for their tenacity and commitment to it. As the first Phase 3 trial of a new microbicide candidate to reach completion, this is a milestone. Skeptics have said that a large-scale effectiveness trial of a product that has to be self-administered regularly over a long time was just too difficult and could not be done. Now we know that such trials can be done with scientific rigor and ethical integrity. This trial also provides important information about safety, use, and acceptability issues that will inform the design of future trials. Three more candidate products are now in Phase 2B/3 trials that will produce results in 2009-2010. These are PRO 2000 and BufferGel (two "early generation" candidates) and an anti-retroviral-based "next generation" candidate, a 1% tenofovir gel. A great deal has been learned in the last 14 years about the mechanics of sexual transmission - how the virus attaches and infects cells. This new knowledge is already shaping new approaches to stopping the virus; approaches that did not exist when Carraguard® was developed. Finally, this is a moment to reflect on our history. The first microbicides advocacy coalition, WHAM (the Women's Health Advocates on Microbicides), was formed in 1993, to help in planning trials for this first candidate microbicide. Comprised of advocates from ten countries on five continents, WHAM gave civil society input into Carraguard®'s trial design and implementation. WHAM disbanded in 1997 to become the Global Campaign - an expanding coalition for the expanding field. The African Microbicides Advocacy Group (AMAG), the Gender AIDS Forum (GAF) and many others have since joined in the civil society effort that now helps to shape microbicide research. Thus, with this trial, we set a new standard for inclusion of community voices in research design and implementation. Microbicide advocates have been actively, visibly, and vocally involved in the research and development process from the very beginning. Our involvement will continue until the goal is achieved - and safe, effective, accessible and affordable microbicides are in the hands of all who need them. Discouragement is a luxury we simply cannot afford - not when the need for new HIV prevention tools is so urgent. GCM, AMAG and GAF have developed a joint press release and an Information Summary on this issue. These materials, together with other, relevant breaking information, are posted on GCM's website at http://www.global-campaign.org/carraguard.htm. Sincerely, Anna Forbes Deputy Director Global Campaign for Microbicides |
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