Seven ways to speed up the HIV treatment pipeline
John McCullagh interviews long-time HIV activist Mark Harrington about getting the best HIV treatments to as many people as quickly as possible.
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.
This month, an older 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. I spoke to him just before his presentation to delegates at the CTAC conference.
John McCullagh: Mark Harrington, welcome to Toronto. You’re in town today to give the keynote address at the CTAC conference on the report authored by you and others about Seven Ways to speed up the Pipeline. Before we talk about that report, perhaps you’d tell me about the Treatment Action Group.
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…
Phase II is?
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.
What are the barriers to getting the best treatments to as many people as quickly as possible?
There are multiple barriers but the three biggest ones that we see right now are the regulatory capacity in developing countries, which is very mixed and often very poor, so they lack the ability to quickly evaluate new drugs and new combinations. This means that the time lag between the approval of a new drug, say in the U.S., compared to, for example, South Africa, which has the biggest epidemic in the world, is about four years. And not all the drugs that are available in the States and other rich countries are available in developing countries like South Africa.
A second major barrier is around so-called incestuous combinations of HIV drugs made by pharmaceutical companies. In other words, combinations of drugs only among those of which a particular company may own the intellectual property as opposed to drugs from two or more companies that would provide a more effective combination. And probably the worst offender these days is Gilead Sciences, which has tried to co-package some of it’s new HIV drugs and Hep C drugs from their own company, which may not be the best combination.
And the third piece is that in rich countries in the current decade we’ll see a wave of drugs coming off patent which can then be manufactured by generic drug manufacturers. Governments will need the political will to commission the best combinations of drugs that will not only meet the needs of their populations but that could also end up saving billions of dollars if it’s done correctly.
So I’m assuming that the recommendations to address these and other barriers contained in your report Seven Ways to Speed up the Pipeline are focused at governments and other decision makers?
Yes. What we tried to do was to break down the seven barriers into areas that needed a lot of sustained attention versus ones that were going okay. For example, one area that’s going okay is the discovery of new drugs for HIV and Hep C (although it’s not going so well for TB as there’s not enough money being invested by industry because most of the cases of TB are in the global South).
Most of the issues we’ve focused on in the report look at those issues that could be moved on quickly, for example improving regulatory capacity in developing countries and addressing the public health needs of people by getting them the best combinations of drugs regardless of who the manufactures are. Those issues could be solved by government action.
So how optimistic are you that your recommendations will be heard and met?
Well, if we’re too optimistic we won’t be fighting hard enough to get the changes that we need to get through. It’s a tough set of problems. We’re dealing with over 100 countries that don’t have sufficient regulatory capacity to deal with their own epidemics. In India, for example, the whole drug development scene is paralyzed by bureaucratic infighting between different agencies and the government, allegedly over alleged ethical infractions. But it’s not clear to me that that’s really what’s happening. Rather, I think, it’s just wrestling between various groups of government bureaucrats. And indeed, there is a freeze on all new clinical trials in India right now, not just for HIV or TB but for all conditions. These kind of bureaucratic roadblocks need to be removed if progress is to be continued to be made.
For those interested in knowing more, where can they read the report Seven Ways to Speed up the Pipeline?
They can go to www.pipelinereport.org where the full report is available to read online or can be downloaded.
Thank you so much, Mark, for taking the time to talk with PositiveLite.com and for the work TAG is doing on behalf of those of us living with HIV and other related conditions.
This interview has been edited for clarity.