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Thu August 21, 2014
Would A Prize Help Speed Development Of Ebola Treatments?
Originally published on Tue August 26, 2014 7:54 am
The human toll of the Ebola epidemic in West Africa is becoming clearer by the day. The virus has killed at least 1,350 people, making this the largest outbreak of the disease ever.
There's no Ebola cure, and only a few experimental treatments are in the works.
One called ZMapp, which contains antibodies against the Ebola virus, was used to treat two Americans who fell ill, a Spanish priest and three health care workers in Liberia, despite the fact that the medicine hadn't been safety tested for humans.
While the World Health Organization has said it's ethical to use unapproved treatments and vaccine in this unprecedented Ebola outbreak, there aren't many options. And supplies of ZMapp "are now exhausted," WHO said Thursday.
What would it take to make Ebola drugs a clinical reality? Financial incentives might help.
Even now, Ebola isn't the most appealing business proposition for drugmakers. While devastating to the people infected, Ebola hasn't, thankfully, been a widespread illness since it was first identified in 1976. Before the current outbreak, fewer than 3,000 people had reportedly died from the disease.
In the U.S., drugs to treat rare diseases have become lucrative, thanks to tax incentives, special regulatory protection and a willingness by insurers and governments to pay for life-saving treatments.
But Ebola, like many other diseases that are mainly a threat in less-developed countries, have been largely neglected by drugmakers.
Dr. Marie-Paule Kieny, WHO's assistant director-general, said last week that the lack of an approved Ebola drug is a "market failure" because the disease typically strikes "poor people in poor countries where there is no market."
Most Ebola drug research has been financed by the U.S. government, she said, with Canada also pitching in.
For Ebola, there may need to be more financial help to get research started and a reward for success. "As an investor, your expectation is that in the future very few people will have this disease and very few will be in rich countries," says Duke health economist David Ridley. "Should you pay money up front for clinical trials, or should you dangle a sufficiently big prize? It's both."
Ridley is one of the architects of an idea to encourage the development of drugs for neglected tropical diseases that has become U.S. law. Companies that get Food and Drug Administration approval for a drug to treat one of 16 neglected diseases disease get a voucher that moves any drug of their choice to the head of the line for agency review. The fast-track voucher can be sold to another drugmaker that's willing to pay for a shortcut.
Earlier this year, Knight Therapeutics, a Canadian firm, won a voucher when FDA approved its leishmaniasis drug, just the sort of medicine WHO's Kieny wants to see more of. Knight is now trying to cash in its leishmaniasis prize by selling the priority voucher to the highest bidder.
Funding by the Defense Department and National Institutes of Health has provide a push for Ebola research, Ridley says. "An extra pull, like the voucher, would be a great move," he says.
Ebola isn't on the list of neglected tropical diseases that automatically qualify for an FDA voucher. But Ridley says that would be easy to fix. The secretary of Health and Human Services can amend the voucher regulation to cover "any other infectious disease for which there is no significant market in developed nations and that disproportionately affects poor and marginalized populations."
That sounds like Ebola, doesn't it?