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Speeding Up the HIV Drug Pipeline
Re-published with permission from PositiveLite.com.
Those who saw the documentary How to Survive a Plague (reviewed by PositiveLite.com) may remember Mark Harrington, one of the young activists who founded the Treatment Action Group (TAG), whose efforts accellerated the discovery and licencing of protease inhibitors, the anti-retroviral drugs that, in 1996, changed the face of HIV from a virtual death sentence into a chronic, manageable disease.
Mark Harrington, now the executive director of TAG, which is still fighting for better treatment of HIV, a vaccine and a cure, was in Toronto to give the keynote speech to the first national conference of the Canadian Treatment Action Council (CTAC). The subject of his address was the recently released report Seven Ways to Speed up the Pipeline.
Mark Harrington: TAG is a community-based organization that’s now in its 22nd year. We were founded in 1992 by alumni from ACT UP New York who worked in the treatment and data groups there. Our focus at TAG has always been on indigenous research and expediting access to the best quality treatments for HIV infection. More recently we’ve also been addressing tuberculosis (TB) and hepatitis C co-infection because they are the leading killers of people with HIV, besides being huge public health issues on their own. And in various ways they are lagging behind the HIV response even though both of them are curable.
So what’s the pipeline?
The HIV treatment pipeline is a way of describing adult and paediatric antiretroviral therapy development and dose-optimization research as well as alternative prevention technologies, research towards a cure, and immune-based and gene therapies. We look at what’s in development like new diagnostic tests, a drug or a vaccine. In the old days we used to look at the pipeline from Phase II to approval…
When something is in clinical trials it usually goes through stages known as phases. Short, early studies are known as Phase II and then, later, more broader trials are conducted which prove that they either work or not. That’s Phase III, which leads to approval or rejection.
In the U.S., we’ve traditionally looked at trials from Phase II to approval and what happened recently was that, working with our colleagues in the UK at HIV i-Base, we worked on a report that addressed the time that it takes to go from discovery of a potential new drug to when it reaches the patient, no matter where they live, not just in developed countries like the U.S. and Canada but anywhere in the world. That meant broadening our perspective on the development pipeline to include regulation in developing countries, normative guidance from organizations like the World Health Organization and the work of generic drug manufacturers.
Basically, if our goal is to get the best treatments to as many people as quickly as possible, and it is, we need to think about all the institutions that need to be addressed, and not just the ones in the rich world.