[Updated and corrected 9/10/14, 10:05 am. See below.] On August 28, Anthony Fauci, the U.S. National Institutes of Health’s top infectious disease specialist, announced a major trial in concert with GlaxoSmithKline (NYSE: GSK) to test new Ebola vaccines in humans. Fauci called it an “all-hands-on-deck response” to the growing global health emergency in which more than 2,000 people have died in West Africa.
Plenty of other weapons are being marshaled, too, but in the fight against Ebola, the U.S. government’s quiver is at least one arrow short. Since 2007, a relatively little-known financial incentive program has been in place to encourage the private sector to develop medicines for neglected tropical diseases. Companies that bring a treatment to market for such a disease receive a priority review voucher to apply to any drug in their pipelines. It’s an intriguing carrot to dangle: cutting a few months from the review process of a potential blockbuster drug can mean tens, perhaps hundreds, of millions of dollars in extra sales if it’s approved.
Bill Gates, speaking in Davos, Switzerland in 2008, was a fan of the idea: “I believe the highest-leverage work that governments can do is to set policy to create market incentives for business activity that improves the lives of the poor… If you develop a new drug for malaria, your profitable cholesterol-lowering drug could go on the market a year earlier.”
[UPDATE: The Gates Foundation announced Wednesday $50 million in emergency relief funds to fight Ebola. An undetermined portion of those funds will go toward R&D for drugs, vaccines, and diagnostics.]
While the voucher program has its flaws, it reached an important milestone this summer: the first sale of a voucher from one drug company to another, establishing a secondary market for those who don’t want to apply the voucher to their own pipeline.
Sixteen tropical diseases qualify a company for the program, including some of the world’s biggest scourges: tuberculosis, malaria, cholera, and dengue fever.
But when lawmakers drew up the list seven years ago, Ebola did not make the cut. It’s never been a widespread killer like many others on the list, and it’s not on the World Health Organization’s list of neglected tropical diseases, either. (“There is no hard-and-fast definition of neglected diseases, but they tend to be persistently present in low-income countries and populations, whereas Ebola is an epidemic disease that only breaks out rarely,” according to WHO spokeswoman Donna Eberwine-Villagrán.)
But the list of diseases eligible for the voucher program differs from WHO’s list in other ways as well (malaria isn’t on the WHO list, for example). And besides, modern population movement and Ebola’s virulence, killing more than half of those it infects, make Ebola’s exclusion from the voucher list puzzling.
“It really should have been included,” BIO Ventures for Global Health president Jennifer Dent tells Xconomy.
In an op-ed published last month in the Seattle Times, Dent wrote, “The current, conventional drug-development approach does not work when it comes to creating treatments for rare and uncommon diseases like Ebola.” She called for “a new paradigm” of cooperation and coordination between the public and private sectors. We’re seeing that cooperation to some extent in a recent spate of news, including Fauci’s August 28 announcement, about programs ramping up quickly.
One could argue whether the action has been fast enough. The outbreak was first detected in March, after all, and WHO outlined one scenario in late August in which the outbreak could run nine months and … Next Page »
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