This has been an amazing month in the search for innovations to fight some of the biggest infectious disease threats of our time. The U.S. Food and Drug Administration (FDA) recently approved a new drug for treating highly drug-resistant forms of tuberculosis (TB), the world’s most deadly infectious disease. Meanwhile, from the Democratic Republic of the Congo (DRC) comes news that two experimental Ebola drugs are dramatically improving the survival rate of infected patients.
These successes — backed by U.S. government funding and developed with partners in industry, non-profits and philanthropy — shine a bright spotlight on both the promise and pitfalls facing efforts to harness exciting new advances in biomedical research to address health threats that don’t typically attract private sector investments.
U.S. support for what is often referred to as global health research and development (R&D) is helping stock the pipeline with new tools to fight an array of alarming threats. They include the rise of drug-resistant HIV and malaria, the spread of dengue fever, and the potential emergence of a pandemic strain of influenza — as well as less headline-grabbing challenges like river blindness and maternal and child mortality.
Millions of lives depend on translating these investments into breakthrough innovations. And the stories behind the new TB and Ebola drugs offer a mix of hope and concern.
The new TB drug, pretomanid, was initially one of several drug candidates produced by the National Institute of Allergy and Infectious Diseases (NIAID), which is part of the National Institutes of Health (NIH). Its development was led by the non-profit TB Alliance that draws funding from a range of sources, including governments, philanthropy and industry.
Pretomanid was approved by the FDA based on results from a clinical trial showed that, when used alongside two other TB drugs, it successfully treated almost 90 percent of patients with highly drug-resistant strains of disease, which are spreading rapidly.
The drug is being hailed as a model for how public-private partnerships can overcome the lack of conventional financial incentives that attract investments in medical advances for other health areas like cancer and heart disease. It’s also seen as a validation of a special regulatory pathway established by Congress in the 2016, 21st Century Cures Act that accelerates FDA review of antibiotics for life-threatening diseases.
A combination of public and private support also has been critical for Ebola drug development. One of the drugs that is showing promise in the DRC was advanced through a partnership with the U.S. Biomedical Advanced Research and Development Authority (BARDA). The other was led by scientists at NIH.
But one reason both the TB and Ebola advances are attracting so much attention is because it has been such a struggle to generate consistent support to fight these diseases, as well as other neglected health challenges in the developing world. Even though TB now affects almost a quarter of the global population and kills more people than HIV/AIDS, pretomanid is only the third FDA-approved TB drug in the last 40 years.
Meanwhile, Ebola drug and vaccine development — though it has made remarkable progress — has been plagued by a frustrating hurry up and wait pattern. There was an initial surge of activity years ago over concerns — which continue today — that Ebola could be a bioterror threat.
But much of that work was shelved due to budget cuts at NIH and the Department of Defense (DoD). Efforts intensified in the midst of the 2014 West Africa outbreak, though interest faltered again before the recent outbreak in the DRC. This kind of inconsistent support makes it incredibly difficult to attract the industry partners essential for taking a drug, vaccine or other intervention from the scientist’s bench to the patient’s bedside.
So how do we ensure that these new breakthroughs on Ebola and TB don’t end up as exceptions to the cruel rule that biomedical innovation is reserved primarily for wealthy countries?
A key factor is to consistently provide ample funding for programs across a number of agencies that are critical to delivering global health innovations. While much attention is rightly focused on the NIH, there are also vital research programs at the Centers for Disease Control and Prevention (CDC), the U.S. Agency for International Development (USAID), DoD, BARDA and FDA that deserve additional support. The chronic neglect and inconsistent funding for TB, Ebola, and other neglected diseases has led to many unnecessary deaths.
Today, there is a growing global coalition of partners committed to seeing more equitable access to the fruits of biomedical innovation. Key champions in Congress and the Executive Branch have played a vital role in achieving this progress. But as TB and Ebola have made clear, diseases are constantly evolving and spreading. Steady and substantial investments in global health R&D represent our best hope of countering their ruthless biology.
Jamie Bay Nishi is director of the Global Health Technologies Coalition, a group of more than 30 nonprofit organizations, academic institutions, and aligned businesses working to advance policies to accelerate the creation of new drugs, vaccines, diagnostics, and other tools that bring healthy lives within reach for all people.