by Scott Gottlieb & Tevi Troy
Dr. Gottlieb, an American Enterprise Institute resident fellow, is a former Food and Drug Administration deputy commissioner (2005-07). He also advises medical-products companies. Mr. Troy, president of the American Health Policy Institute, is a former deputy secretary of Health and Human Services.
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The world is finally mobilizing to wage a muscular fight against Ebola’s catastrophic spread through West Africa. President Obama has put the Pentagon in charge of a robust, 3,000-person U.S. relief effort in the stricken areas. This is a positive step, but the world is still dangerously ill-prepared for the fight against pandemic outbreaks.
In the case of Ebola, we were late to the battle and are now focused too narrowly on places like Liberia while failing to see West Africa as one big outbreak. We also remain too dependent on outdated tools and strategies in fighting the virus, and are tethered to an effort not yet scaled to the challenge.
While Ebola may still be contained, other potentially calamitous threats are out there. MERS, SARS, avian flu and other illnesses could re-emerge at any time. In the American Midwest, for instance, a novel virus classified as Enterovirus 68 has recently sent some 300 children to the hospital in respiratory distress, with no available antiviral therapy or vaccine. We need to rethink our preparedness and adopt a more modern approach for dealing with these and other looming outbreaks.
The failure thus far to confront and fight Ebola comes from shortfalls in three areas: gauging the true scope of the outbreak, deploying therapeutics to effectively combat the virus, and delivering medical equipment and personnel. Fixing these limitations should be the priority in dealing with this epidemic and the next one.
First, on detection: Fighting deadly diseases requires early detection and a clear understanding of the magnitude of an evolving threat. In West Africa we drastically underestimated the timing and scope of Ebola’s transmission and still can’t accurately measure the magnitude of its spread.
Ebola is not the only modern instance of the world coming up short. During the 2009 H1N1 influenza outbreak, health organizations were slow to detect the emergence of a problem in Mexico. Even after press reports that Mexico was experiencing a “late flu season,” public-health officials failed to grasp that a novel infection was coursing through that country and would soon arrive in the U.S.
Using new screening technologies and innovative detection approaches as simple as spikes in Google searches that indicate health anomalies, we can better sound the alarm of a pandemic threat. We also need to develop better coordinated, real-time responses among national health bureaucracies that are often slow to respond and do not communicate effectively among one another.
Second, on therapeutics: In 2004 Congress passed Project Bioshield to finance the development and stockpiling of medical countermeasures against the likely agents of would-be bioterrorists. This effort was augmented in 2013 with the Pandemic and All Hazards Preparedness Reauthorization Act. Other measures have been targeted at tropical diseases, and all of these efforts have improved our biological readiness, but dangerous gaps remain.
One problem is that federal grants are awarded to offset the direct costs of development and manufacturing of medical countermeasures but not the true cost of risk-taking to develop novel approaches. The Bioshield grants, for example, are used by some small biotechs to offset the costs of existing drug programs. Many companies repurpose drugs they already have on the shelf toward biodefense uses, hoping that their product might eventually make it into government stockpiles, generating a bigger return.
The program doesn’t provide for market-based rewards for innovation and risk-taking. As a result, companies are still reluctant to make the substantial investments needed to develop new medical countermeasures. To take one example, as far back as 2000 the National Institutes of Health announced the development of
“a novel vaccine that prevents Ebola virus infection in monkeys.”
Yet the 2014 Ebola crisis struck without a vaccine available for humans.
The challenge is that there’s no natural market for therapeutics aimed at bioterrorism or rare diseases, other than government stockpiling. To these ends, the Biomedical Advanced Research and Development Authority should develop a more explicit, prize-based system to offer market-based rewards for programs that successfully develop new countermeasures to national security risks. Grants could offset the direct costs of research and manufacturing, with prizes providing the requisite return.
Third, logistics: The World Health Organization’s failed response to the Ebola crisis shows anew that the group is more a politically minded policy-making body than a relief agency. The WHO claims that it lacked the resources to respond to Ebola, but while the outbreak was spiraling out of control in West Africa, the organization had plenty of time and money to mount an international campaign to combat what it flagged last month as a “grave concern.” Not Ebola, but electronic cigarettes.
We need to create an off-the-shelf logistical enterprise capable of inserting public-health resources to snuff out contagious threats that have pandemic potential. Such a capability might reside with the United Nations, or better, the North Atlantic Treaty Organization, so that when a deadly virus emerges in developing areas the U.S. and its allies can control its spread before it hits major population areas. We need to think about the same issue domestically as well. If the Ebola pandemic were to come to the U.S., it is unclear who would lead the response: The Department of Health and Human Services has the expertise, but the Defense Department and Homeland Security have the assets.
Ebola shows the danger of diseases developing and spreading around the world from a key convergence point. As Richard Preston wrote in his 1994 nonfiction best-seller “The Hot Zone,” when a novel virus emerges, the warning sign may be a series of small outbreaks at different times and places. These “microbreaks” can eventually re-emerge like Ebola has and become a pandemic. How many Ebola microbreaks were missed or not taken seriously? And how many other lethal pathogens—from MERS to SARS to Enterovirus 68—are we too casual about today?
The Department of Homeland Security’s inspector general just issued a highly critical report finding that DHS lacks sufficient supplies and preparedness to handle a domestic pandemic. Thirteen years ago, soon after the 9/11 attacks, letters laced with anthrax killed five Americans. Just as 9/11 revealed the country’s vulnerabilities to terror attacks, the anthrax episode exposed the need for better routine surveillance and strategic stockpiling of key countermeasures against viral outbreaks or bioterror attacks. We’re still far less prepared than we should be, and far more vulnerable than we’re admitting.