The Past, Present and Future of HIV Microbicide Research Advocacy
An Interview With Polly Harrison, Founder of the Alliance for Microbicide Development
Do you think research on microbicides has enough political support? Enough research support? Enough commitment to do the research necessary to operationalize microbicides when we have evidence they work?
Short answer: probably not. Let me take each of your questions individually.
Political support: We managed to develop a lot of political attention that, while we never got actual legislation passed, leveraged the supportive NIH responses I mentioned earlier. I don't think microbicides command that same level of political support now for several reasons:
Research support: The economic environment obviously affects funders, who are overwhelmed, confused and less well-resourced. In the case of microbicides, many donors lack the internal resources or standardized access to true peer review processes to make decisions, so that each donor is vulnerable to the pleadings of individual groups and their own inabilities to assess those.
Commitment: I wish I knew. Some donors clearly remain committed, but some are pressured by economic realities and multiplying demands. Others can't deal with the realities of scientific and pharmaceutical research, even though such research is well known to be erratic, inconclusive, sometimes just plain disappointing, before success is ever reached -- if ever.
What are the lessons learned from the unsuccessful microbicide trials?
Like HIV vaccines, we know what we won't do again, and more about what we don't know. Did we move too fast into the clinic with not enough data? No and yes. In some cases, we didn't have the tools to know what we didn't know and couldn't answer without more human data. In others, we thought we knew more than we did, there was a sense of urgency -- that, frankly, has not gone away -- and we should have asked more questions sooner. As for the scientific questions, there's been much probing of those lessons by independent researchers and analysts. What we haven't done is pull those lessons together into a coherent statement to the scientific world. We do know that we won't invest in microbicide candidates that can't balance safety and efficacy in the lab -- i.e., no more surfactants, no more polyanions.
What are the lessons learned from the successful TDF 5% gel trial?3
Many! The biggest and best is that the concept of a topically applied microbicide is feasible and merits pursuit. We learned that women will use such a product, their partners mostly don't seem to mind and that women who use it most benefit the most. We also learned what we don't know: most importantly, how such a product will be used in "real life"; whether partners will continue to "not mind"; and what frequency of use will provide the necessary level of protection. And for me, one of the most important lessons was the finding that tenofovir was 51% effective in preventing genital herpes infections, and follow-on trials will be exploring that very important fact further.
Are you satisfied by world reaction to CAPRISA-004?4
I'm thrilled! Now we can say that topical microbicides have an accepted identity as an HIV prevention technology worth pursuing. We've had some long dark years sprinkled with disappointment, some loss of faith and, frankly, some disdain. To see the joy and hope in so many quarters is beyond gratifying. Not every quarter, which is distressing, but most.
What plans are underway to validate that result?
There are multiple plans and that's a problem. There are earnest efforts to coordinate and find consensus about what should happen next, but those are confounded by understandable vested interests, funding constraints; and maybe a bit of human cussedness. I feel better since the stakeholders meeting USAID convened a few weeks ago, where a deadline was laid down for producing a road map and timeline for next steps. There is progress in taking some regulatory steps and bridging trials are being designed. But there's no agreement about which trials will be needed to confirm the CAPRISA-004 results and by whom. Even the best road map will have to be accepted by all the key players -- and there's the rub.
Goosby, Emanuel Address Progress, Potential Roadblocks Ahead for Introduction of Microbicides in Developing Countries
This article was provided by Treatment Action Group. It is a part of the publication TAGline.
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