Observations on the role of innovation in the battle against HIV/AIDS
Getting to Zero is the theme of this year’s World AIDS Day: Zero HIV/AIDS-related new infections, deaths and discrimination by 2015. I wholeheartedly endorse the idea and admire the ambition level. But this World AIDS Day falls on the heels of some bittersweet news.
On one hand we have last week’s report from the Joint United Nations Programme on HIV/AIDS (UNAIDS) telling us that 2011 has been a “game-changing” year in the fight against HIV/AIDS with unprecedented progress in science, political leadership and results. On the other hand the Global Fund had a “getting to zero” announcement of a different sort. Last week they announced there would be zero funding for new HIV/AIDS-related initiatives until 2014. A statement from Médecins Sans Frontières (MSF) summed up the situation: “The dramatic resource shortfall comes at a time when the latest HIV science shows that HIV treatment itself not only saves lives, but is also a critical form of preventing the spread of the virus, and governments are making overtures that there could be an end to the AIDS epidemic.” The statement goes on to urge governments to step up and find the money required by the Global Fund. A second statement issued two days later went further asserting that “The international community must recognize that we are at a critical crossroads: we either use the science, tools, and policies already at our disposal to save lives and prevent new infections; or see the hard-fought gains of the last decade lost.”
No doubt, fundraisers will need to work hard to stimulate giving in the current global economy. When they succeed, I hope they will turn their attention to a much less publicized but equally important issue: stimulating competition and innovation in the markets where those funds will be disbursed. Because that is what will be needed to get to zero in the countries hardest hit by HIV/AIDS — particularly if funds are frozen and we find ourselves in a catch-up situation one, two or more years down the road.
I have complete confidence in the ability of the biotech industry to accelerate progress in the war against HIV. But to do that they will need a balanced playing field on which to compete. Currently, that is not case in several critical and underserved areas of HIV diagnostics. For instance, a 2008 report from the Global AIDS Alliance (themselves the victim of funding woes in 2010) cites one company that “controls roughly 80% of the overall NAT [nucleic-acid-based tests] market share, which gives the company a near monopoly on global diagnostics and even greater domination in the area of EID.”
More recently, at the IAS in Rome this past summer, Maurine Murtagh reported that the market conditions in resource-limited settings for three of the most critical and under-served areas on HIV management are monopolized by a few large companies. One company controls 80% of all CD4 testing. Two companies have 70% market share in viral load testing. And one company has 90% market share in early infant diagnosis (EID).
At the same time Ms. Murtagh highlights the inadequacies of the solutions provided under these monopolies. “Diagnostic delivery of EID, CD4 and viral load testing is generally via large and relatively expensive laboratory-based systems that require well-trained technicians and good sample transport networks to provide access to testing for those in some urban, and virtually all peri-urban and rural settings.”
I have spent most of my career in the private sector where monopolies are frowned upon if not banned outright. As we all know, monopolies create huge barriers of entry for new products, stifle innovation, discourage investment and keep prices inflated. When I became CEO of Cavidi, a biotech firm specialized in HIV diagnostics, I was surprised to discover how monopolies are a fact of life in the very markets that are most in need of innovation and investment. I was equally surprised at how resistant to change these resource-limited markets are despite the clear limitations of the current diagnostic solutions.
This is not to slight the contributions made by the companies who dominate these markets. In Cavidi’s diagnostic area, imbedded technology can be credited with contributing to the progress detailed in last week’s UNAIDS report. However much of this technology was created for use in developed nations and has changed little over the past 20 years to adapt to the very different environment we see in resource-limited settings. This is the predictable result of any monopoly — stagnation. In the case of HIV diagnostics, stagnation means that many of the people who need the tests most cannot access them for the reasons cited by Ms. Murtagh.
This situation is not the byproduct of a market that lacks innovative solutions from creative companies. A look at the UNITAID HIV/AIDS Diagnostic Landscape publication gives you an idea of the vast number of more effective solutions including our own RT-based diagnostic assay which, in addition to lab-based viral load monitoring in resource-limited settings, has the potential to provide a viable, cost-effective solution to elusive problems like EID and near-patient viral load monitoring.
Of course these solutions need financing to scale up. But they also need an efficient market that promotes competition and encourages new ideas and better solutions. Until those conditions exist very few new ideas from smaller, entrepreneurial companies like ours will ever be allowed to contribute on par with their potential. So with regard to diagnostics, the real challenge in getting to zero by 2015 isn’t, “Where can we find the next big idea?” It is, “How can we hasten the uptake of ideas we already have in the presence of a monopoly?”
The benefits of such competition and ingenuity in places like Sub-Saharan Africa, India and Southeast Asia don’t stop there. The solutions developed for resource-limited settings are often just as applicable in developed nations. For instance our ExaVir™ viral load test is as sensitive as the gold standard but it can also detect all known HIV subtypes. This is something that the gold standard cannot do and the reason why our test is also being used in some of the world’s most prestigious medical institutions, such as the Royal Free Hospital in London and the University of Maryland School of Medicine IHV (Institute of Human Virology) in the U.S. Further, given the burden felt by most healthcare systems in developed nations the need for more cost-effective diagnostic solutions is not limited to developing nations.
Today, the science exists to address some of the most pressing challenges in getting to zero but is often confounded by a market that clearly does not welcome new entrants gladly. This is not the type of problem that is solved by money alone. It’s also a matter of mindset. So on this World AIDS Day I join the plea for donor nations to ensure that their pledges to the Global Fund are honored. And to that I would add a plea for recipient nations to ensure that the entire HIV treatment spectrum, including diagnostics, is allowed to evolve and thrive under market conditions that encourage competition and innovation. With both funding and innovation nothing can stop us from getting to zero in record time. That is my wish today, and my colleagues and I are honored to be part of this historic endeavor.
John Reisky de Dubnic
CEO
Cavidi
November 30, 2014 
The time for viral load testing is now.”For years this has been the focus of this company and each of our employees. Today, it has become policy for developing nations around the world as recommended by the World Health Organization (WHO).
