PrEP and a Patent

So. The Washington Post has postulated that the US Centers for Disease Control may have a US patent on tenofovir when it is used in PrEP. Many questions, and no clear answers to this story, yet. I have no doubt that the CDC and Gilead have the best attorneys on retainer, and that they will sort out what happened, or didn’t happen.  And they need to, quickly. Because we need to focus on the broader emergency of US funding for AIDS at home and abroad.

The news also reported on a campaign led by activists which, amongst other things, seeks to end the Gilead patent on Truvada for PrEP in the USA.  I deeply respect fellow activists, who commit day in day out, sometimes at terrible risk to themselves. We are united by a common fight against a terrible virus, and the injustice it thrives on. There are activists in community organizations, research institutions and in the private sector. I don’t ever doubt their commitment. That doesn’t mean I always agree with every tactic.

 So, a few comments on the above.

In the late 1990s – Peter Young, a foundational business leader at what was then Glaxo Wellcome (and became ViiV), pioneered HIV preferential pricing, whereby companies slashed prices of aids medications for use in public health programs in developing countries. What is obvious now, was not then. Would preferential pricing lead to a collapse in the industry? Would governments buy treatments for people with HIV anyway? From an industry that was conservative in its thinking, there rapidly came agreements from nearly all major pharmaceutical companies, facilitated by Kofi Annan and Peter Piot. From thereon, Gilead, a new muscling player in the field, revolutionized the provision of technology transfers and licenses to a number of, primarily, Indian pharmaceutical manufacturers. These manufacturers (we often call them “generics”) had significantly cheaper manufacturing costs compared to American and European peers. Such arrangements went on to be made by individual companies and through mechanisms like the Medicines Patent Pool. With massive funding though PEPFAR, the Global Fund, and domestic health departments, a generation of people living with HIV, including many friends and colleagues, were saved.

Treatment been the crowning achievement of the AIDS response to date, and with it, an understanding that if your virus is suppressed fully, you do not pass on the virus. The U=U movement has been a monumental achievement: The community has taken scientific evidence and given it deep personal meaning, enthusing all sorts of different communities from all over the world. It is rooted in an equally incredible mobilization of community treatment preparedness, that I was honored to be a part of for a few years. There are exciting innovations in the delivery of PrEP led by communities around the world, and it is complementary to outreach, education and information about HIV (a shameless plug for my podcast A Shot In The Arm which is launched tomorrow, Friday 5th of April).  

Starting in the 2000s, industrialized nations, particularly the US Government, the pharmaceutical industry, and some foundations, notably Gates, invested millions in prevention research and development to evaluate the value of antiretroviral medicines to prevent HIV infection. This research was done, in large part, in the global south with the aim of benefiting the global south. As I understand it, Gilead provided free clinical supply of medicines to the trials. If the research worked, then public health programs would access cheap medicines in the developing world, and private companies would continue to market their medicines in the industrialized world. The model is being today used for new drugs, formulations and delivery mechanisms.

I don’t think the role of the bio pharmaceutical industry has been properly recorded (would some foundation please give Jeff Sturchio and Dave Ripin six month sabbaticals to write it) and there are strange allies and surprising opponents. There was undoubted pressure from activists, public health officials, governments and the U.N. and there was pressure from inside the companies themselves.

The broader principle that was successfully fought for from outside and inside the bio pharmaceutical industry is this: Continued private sector research and development must be incentivized for diseases for which there are not adequate markets in the developing world. The returns that fuel the engine of private sector-based research and development come from the industrialized world. HIV is fairly unique; in that it is not exclusively a disease of poverty. It can affect anyone regardless of their geography.

The models of drug development partnership developed in the 2000 have largely been a success. Let’s be honest: The public and non-profit sector have proven themselves inadequate in bringing to market new medicines on their own. And the flip side is also true, that the private sector, on its own, has proven itself inadequate in developing and marketing new medicines for the world’s poor. I don’t think annual US price rises above the rate of inflation, or the relentless waves of tv advertisements that fill our TV screens (and hinder my education and enjoyment of MSNBC’s Rachel Maddow) help industry make its case. No doubt, there is change coming. But I argue that the access approach championed by Gilead and others shows us the way forward and should not be jettisoned.

In complete transparency, Hunuvat receives funding from the private sector, including from Gilead to support the mobilization of greater public private partnerships in the global response to infectious disease.

The WSJ reporting also points to the woeful state of US domestic and international AIDS funding. Under this administration, funding for HIV domestically and internationally has never been at greater threat and yet more urgently needed. Claims of “ending AIDS” are matched by real cuts in women’s access to reproductive health. Trans people are being discriminated against. We are being lied to and misled.

We have a sixth replenishment of the Global Fund to secure in October. Two important things here. Firstly, a number of companies have sent a letter to Congress urging the US to continue, and deepen its investment in the Global Fund. And secondly, the most important news item of last week, for me, was Congresswoman Barbara Lee challenging Mike Pompeo over his assertion that the US could end AIDS and reduce its investment to the Global Fund, at the same time. She perseveres, and he dissembles. It is chilling.

 We cannot be distracted: It is this indolent misjudgment that demands our upmost bipartisan unity in opposing.