The lack of an Ebola cure amid the deadliest outbreak in the disease's history is highlighting a significant challenge in the public health world: developing life-saving cures to those who need them the most. In many cases, drug manufacturers don't have strong enough economic incentives to devote resources to making drugs for populations that would have trouble affording them.
"It’s a market failure because this is typically a disease of poor people in poor countries, and so there is no market," said Marie-Paule Kieny, assistant director general of the World Health Organization, on Tuesday.
ZMapp, the San Diego company that sent an experimental Ebola drug to Liberia, said its supply has already been exhausted, as a handful of other drugmakers are racing to get approval for their treatments and vaccines. The World Health Organization, meanwhile, on Tuesday said it's okay with allowing unproven, experimental drugs to help stop an outbreak that's already killed more than 1,000 people mostly in Guinea, Liberia and Sierra Leone.
The problematic lack of effective cures isn't just limited to just Ebola. There's a whole category of "neglected diseases," which affect about 1 billion people in low-income countries, according to WHO estimates. The high cost of developing drugs, combined with an inability of the patient population to afford them, have left these diseases without treatments.
"It's the failure of the whole research and development effort for these kind of therapies," said Georges Benjamin, executive director of the American Public Health Association. "Ebola is just the most recent example."
Despite the large populations of neglected disease sufferers, however, just 4 percent of 850 therapeutic products approved by various regulatory agencies between 2000-2011 were for so-called neglected diseases, according to research published in Lancet Global Health last year. Still, that was an increase in the 1.1 percent rate between 1975 and 1999, and researchers said the improvement was a sign of greater private and public efforts to reduce the imbalance.
The global research and development investment for neglected diseases totaled $3.2 billion in 2012, with almost two-thirds of that coming from the public sector, according to the G-Finder annual survey from Policy Cures. Drug companies pitched in about 16 percent, or about $527.2 million in all, the survey found.
So the key question is how to encourage drugmakers to develop cures for these diseases, when the economic incentives don't match up with the public health needs. For drugmakers, the system incentivizes them to focus research and development efforts on products that will pay off. Think blockbuster drugs that come with patent protections.
"You really have to break this link between patent monopolies and research investment," said Bryan Collinsworth, executive director of Universities Allied for Essential Medicines.
WHO has been exploring alternative incentive structures. The group has looked into a "prize fund" approach, among other ideas. Under this model, a centralized fund would reward drug manufacturers at the end of the drug development process or for hitting research and development milestones along the way.
The United States has its own efforts, too. In 2007, the Food and Drug Administration created a voucher program meant to encourage the development of cures for neglected diseases — if a company receives FDA approval for such a drug, the company would then receive a voucher to speed up the agency's review time for another drug application. However, just four vouchers have reportedly been awarded under this program so far. The National Institutes of Health has also run the Rare Diseases Clinical Research Network since 2012 to try to fill in the funding gap. The NIH network is studying about 90 rare diseases at almost 100 U.S. and international academic institutions, according to an agency fact sheet.
There's also the 30-year-old Orphan Drug Act, which provides up to a 50 percent R&D tax credit to develop drugs for diseases affecting fewer than 200,000 people in the United States. Still, even when those drugs become available, there's no guarantee that patients will be able to afford them. Pharmaceutical companies enjoy a7-year exclusivity window protecting intellectual property for these orphan drugs, which canmake their costs prohibitive for patients, Collinsworth said.
"The big downside of the Orphan Drug Act is they did not say in exchange for this massive tax credit you actually have to lower the price of finished product," he said.