[Ip-health] Al Jazeera: What the Ebola crisis tells us about our failing drug development system
els.torreele at opensocietyfoundations.org
Thu Nov 6 10:42:45 PST 2014
Ebola in West Africa is a wake-up call
What the Ebola crisis tells us about our failing drug development system.
Els Torreele & Piero Olliaro
Eight months into the world's worst Ebola outbreak, we have lost 5,000 lives and expect to see more infections and deaths in the coming months. The reason is simple: We have no drug to cure Ebola, or vaccine to prevent it.
It didn't have to be this way. If medicines were actually developed to respond to health needs, we would already have effective vaccines and drugs to prevent and control this deadly disease. Instead, health workers can only provide supportive care, and watch as 70 percent of patients die<http://www.nejm.org/doi/full/10.1056/NEJMoa1411100>.
Many have lamented the lack of Ebola drugs and vaccines as a "market failure<http://www.independent.co.uk/life-style/health-and-families/health-news/ebola-outbreak-big-pharma-failed-victims-why-9716615.html>". Because Ebola outbreaks have historically been sporadic and only affected a few people, drug companies have not seen a big enough market to invest in it, even if a great deal of government funding has gone into supporting early research.
But this market explanation is only part of a larger reality. Our current system for developing new medicines is by design ill-suited to address the world's health needs.
Ebola is only the most recent illustration of how this system fails us. There is a dearth of drugs and vaccines for many infectious diseases. We have come to accept that drug companies will not invest in diseases that primarily affect the poor, such as the so-called "neglected" tropical diseases, leaving millions of people without cure for what are essentially treatable diseases. But are we ready to accept that, despite all scientific and technological progress, we lack medicines for global threats like multi-drug resistant tuberculosis, and have no effective antibiotics to protect us against the "superbugs<http://www.pbs.org/wgbh/pages/frontline/hunting-the-nightmare-bacteria/>" menacing even the best-equipped hospitals?
Instead of generating much-needed medicines, our current system gives companies incentives to make blockbuster drugs that generate billions in sales, even if they are redundant from a medical perspective: Some 70 percent of "new" medicines developed, provide no added therapeutic value<http://english.prescrire.org/en/8D5E3E4219E9CD603D118310BAE923F6/Download.aspx> over what we already have. When new drugs do present a medical breakthrough, they are priced at levels that strain even wealthy health systems, let alone individual patients. A case is point is Gilead's new $1,000 per pill<http://www.bloomberg.com/news/2014-07-23/doctors-dilemma-who-gets-costly-cure-for-deadly-virus.html> hepatitis C drug, Sovaldi, which remains largely inaccessible for the majority of hepatitis C patients worldwide.
The Ebola crisis shows how our system also fails in response to epidemic outbreaks, which are by definition infrequent and unexpected. We need to invest in research in between outbreaks to have drug and vaccine candidates ready to be tested as soon as the next one hits. While several Ebola drug and vaccine candidates have existed for some time, neither the public institutions that funded and conducted the early-stage research, nor the drug companies who would develop and manufacture them, prioritised these candidates. This was especially so, once the US government no longer saw Ebola as a potential bioterrorism threat<http://www.bloomberg.com/news/2014-10-23/cheney-in-post-9-11-era-may-be-to-thank-on-ebola-vaccine.html>.
We urgently need to design an alternative system to conduct, prioritise, and finance medicine development where the primary payback is improved global health, not shareholder profits. This includes mechanisms that will allow drugs and vaccines to be developed but then held on our shelves until needed. This can only be achieved if we have strong public health leadership that views medicines as public goods, not commodities to generate profit.
Thankfully, a publicly supported response to Ebola is emerging, with several drug<http://www.reuters.com/article/2014/10/21/us-health-ebola-msf-idUSKCN0IA24N20141021> and vaccine<http://www.nytimes.com/2014/10/25/business/ebola-vaccine-trials-planned-for-december.html?_r=0> trials about to start in West Africa. Instead of doing business as usual, relying largely on pharmaceutical companies to develop proprietary products, we can pilot a different paradigm of collective action under public leadership.
We need public leadership to promote open-source medicine development. Currently, knowledge of both the virus and its drug and vaccine candidates is limited and dispersed among individual researchers or companies. Pooling all available knowledge from previous and new studies into an open access database would not only limit duplication and accelerate research, but also allow crowdsourcing - asking the best scientific brains in the world to come together with new ideas and solutions.
We also need public leadership to provide rules and methodologies that facilitate the testing and registration of the medicines we need, and ensure their timely access and affordability. This will require creative and public-interest-focused management of patents and ownership issues that takes into consideration the significant public investments made in different stages of research and the public health need being addressed. It would ensure immediate and affordable access to medicines for all who need them.
The outbreak of Ebola in West Africa has been a wake-up call. It questions the effectiveness of our emergency preparedness and highlights the need for strengthening our health system. But, it should not stop there. We must seize this moment to rethink our drug and vaccine research and development system, aspiring for one that can respond to such a crisis because it is propelled by global need - not corporate greed.
For a more in-depth look into the impact of big pharma on the developing world, we have an award-winning documentary, Fire in the Blood. Available online<http://www.aljazeera.com/programmes/specialseries/2014/10/fire-blood-2014102384236524375.html> from November 1-10. This investigation uncovers the devastating restrictions big pharma places on life-saving HIV/Aids medication in the developing world.
Els Torreele is the director of the Access to Medicines Initiative of the Open Society Foundations.
Piero Olliaro is the head of intervention and implementation research at the Special Program for Research and Training in Tropical Diseases, World Health Organization, and Newton-Abraham Visiting Professor at the Center for Tropical Medicine at the University of Oxford.
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