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In September 2001, following the sophisticated terrorist attacks on U.S. soil and the anthrax letters soon after, the reality of the nation’s vulnerability to biological attack was acute and in need of rapid and sure response. Even as a national strategy was being developed, the nation’s leadership was taking certain actions based on the nature of biological attacks. It had to deal with a potential attack with no “boom” until hundreds of thousands of people were ill and in need of critical medical care, reverberating to the point of threatening confidence in the U.S. government.

In his State of the Union speech in 2003, President George W. Bush addressed this threat and the nation’s vulnerability by announcing the deployment of biological detectors in major urban areas of the country. This feat of acquisition and logistics, known as BioWatch, was completed in just over one month. The BioWatch program incorporated off-the-shelf environmental sample collectors deployed in urban areas and standard polymerase chain reaction (PCR) tests performed in local public health laboratories to detect the presence of a small number of unaltered biologic agents believed to be of interest to terrorists. Within a year or two, the BioWatch program was fully institutionalized in a federated network, planned and funded centrally and implemented locally. Upon the formation of the U.S. Department of Homeland Security (DHS), its Science and Technology Directorate assumed the federal funding and coordinating role.

A year later, a national strategy was issued by the President, Biodefense for the 21st Century, Homeland Security Presidential Directive 10 (HSPD-10), based on four pillars of activity: (a) threat awareness; (b) protection and prevention; (c) surveillance and detection; and (d) response and recovery. The BioWatch system thus fulfills a central requirement of this strategy.

Following the deployment of the early BioWatch system, its limitations were well known to DHS, including limitations of off-the-shelf environmental sample collectors, infrequency of sample collection and processing, slowness of reporting, and tortuous decision making following the detection of the presence of pathogens in the environment. DHS issued a request for proposals for fully autonomous detectors operating in continuous mode to cut down the response time, which is critical to enable the distribution of post-exposure countermeasures. Responding to the request were a few small technology companies as well as large defense and aerospace corporations; the broader biomedical industry was not well represented. Nine years after introducing the BioWatch program, DHS has still not been  able to deploy a system that meets all of the requirements, including and especially the cost requirements set by the department. As the nation faces the need for extreme budgetary discipline, cost estimates to deploy a system of autonomous biodetectors are greater than $3 billion, in addition to a hefty operations and maintenance bill every year.

The question of whether there are new technologies that can leapfrog PCR at a lower cost has been raised. Biomedical companies that compete in the space of rapid pathogenentification are in abundance, but their innovation has not been applied to this national defense purpose. Biomedical pathogen detection andentification does not require the same degree of sensitivity coupled with 100-percent specificity as BioWatch, and does not need to operate outdoors in hostile environments. Yet, the question remains whether biomedical innovation can step up to help solve this national security conundrum.

Key Findings

The survey, “Advancing Technology in Biological Surveillance and Detection,” provides interesting insights into the preferences and beliefs of the key constituency of the U.S. Department of Homeland Security (DHS) – i.e., those who will plan, equip, train for, and execute a response to an intentional release of a biological agent. The results reflect where the nation is in the evolution of its biodefense readiness posture.

A healthy consensus among the respondents reinforces the underlying requirement for a robust environmental detection system for biological agents:

  • The risk of a bioterrorist attack is the same or higher;
  • Detection in the environment is necessary before sick people present to emergency departments; and
  • In the absence of a robust system, the first warning likely will appear when people start getting sick.
  • There is also broad consensus on the importance of shortening detection times to a cycle occurring several times a day, although nearly half of the respondents are concerned with the expense of doing so, probably given the cost estimates of the current system. The truncation of the response time is needed to allow for the distribution of countermeasures in the window of effectiveness and the need for rapid attribution toentify the enemy and prevent subsequent attacks.
Jeffrey W. Runge

Jeff W. Runge, MD, is a Principal with the The Chertoff Group and a consultant in biodefense, medical preparedness, and emergency medical care. In 2005, he became the Department of Homeland Security’s (DHS) first Chief Medical Officer and founded the Office of Health Affairs at DHS, where he was Assistant Secretary for Health Affairs until 2008. As such, he was responsible for DHS’ biodefense and medical readiness programs as well as providing support to the Secretary and the DHS components on all medical and public health issues. From 2001 to 2005, he served as head of the National Highway Safety Administration where he drove changes in vehicle design and equipment and safety belt programs that contributed to a 30% reduction in fatalities over the decade. He is board certified in emergency medicine, having practiced and taught in a high-volume emergency and trauma center for 20 years. He is now an Adjunct Professor in the University of North Carolina School of Medicine in Chapel Hill, NC.

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