Director's Update

24 April 2008

The Alliance is pleased and proud to welcome you to our new web site and invite you to join us in celebrating the 10^th anniversary of our founding.

When the Alliance started in March 1998 with a small seed grant from the Rockefeller Foundation and support from a few enthusiastic friends, microbicide research, development, and advocacy were limited, disjointed, and woefully under-funded. The Alliance was envisioned as a novel way to change this situation and create a "microbicide field". How? By forging links among all for whom microbicides were a priority and shaping a culture for sharing information, sidelining institutional agendas, working toward common objectives, and recruiting resources.

We did that. The potential contribution of microbicides to reducing HIV transmission has been increasingly accepted as valid, policy and financial support have grown, and the pool of engaged scientists has broadened and deepened. But there is a lot more to do and some of that is urgent.

Why? Because after a few hopeful years, the microbicide field finds itself at a crossroads. The recent microbicide trial failures and closures have been sobering, their implications plentiful and profound. Some have described these events as "disastrous", even "catastrophic", and certainly the term "devastating" for the hard-working folks at the trial sites is fair enough.

But as some dealing with the recent HIV vaccine failures have observed, some perspective is in order. Finding any vaccine is slow and difficult; the same is true for microbicides. Vaccine failures are common; the same is true of microbicides. AIDS scientists are rededicating themselves to more basic research; the same must be true of microbicides.

There is more. While microbicide and HIV vaccine trials share some similar challenges, microbicide trials are burdened by a particular demand that does not weigh on vaccines, namely an utter dependence on participant reports to confirm product use. For this and other reasons, microbicide trial design needs some rethinking. There are earlier questions: Are preclinical and early clinical testing using the right tools, asking the right questions, and reading the answers right? And perhaps the hardest question of all: how do we remedy the fact that decision-making about which candidates to advance through the pipeline lacks sufficient information, common systems, agreed-on criteria, and adequate peer review?

The microbicide field is a decade younger than the HIV vaccine field and continues to offer promise with new lines of inquiry, a preclinical pipeline that is thin but not empty, 12 products in clinical development, and a cadre of engaged scientists. This is the time to make every effort so that the progress of these candidates and those coming behind them is based on the best analytical tools and selection processes. Failures are standard fare in drug development, but failing to learn from them, systematically and strategically, is not an option.

Polly F. Harrison, PhD
Director, Alliance for Microbicide Development