Assessing progress in how the national biosurveillance program is performing.
A week after the 9-11 attacks, five threatening anonymous letters were sent to media outlets. Two weeks later, reporter Robert Stevens became the first person to die from inhaling anthrax that was enclosed with the letters. The case widened as anthrax-laden letters were sent to two Senators—one of the letters arrived at a Capitol Hill office and the other was routed to a mail facility, where it infected postal workers. Before the terror ended, 22 people developed infections and five died.
In response, the federal government set up the BioWatch program, an early warning network of sensors that would detect biological attacks before widespread public infection could occur. By the time President George W. Bush publicly announced the program in 2003, BioWatch filters had been deployed in 31 cities and more than $60 million had been spent on the program.
The program came under criticism early on. In 2003, a congressional report raised concerns about almost every aspect of BioWatch, from the funding to the implementation to the scope of coverage. Today, more than $1 billion has been spent on the program, which has expanded to 34 cities across the United States, yet the concerns about the program remain.
BioWatch has deployed outdoor collectors in all of the cities where it is operational and indoor collectors in three locales; more can be deployed during major events. The collectors hold filters that gather air samples, and a government worker manually retrieves the filters and delivers them to laboratories for testing every 24 hours.
The Department of Homeland Security (DHS) Office of Health Affairs oversees and coordinates the BioWatch program. The Environmental Protection Agency (EPA) monitors the filters, which are deployed with existing EPA equipment that monitors air quality. The Centers for Disease Control and Prevention (CDC) provides technical assistance in testing the air samples for pathogens terrorists are likely to use in a biological attack, including anthrax, small pox, plague, and tularemia. The FBI gets involved whenever a BioWatch Actionable Result (BAR), a positive result, is recorded. But state and local health officials take on the brunt of the day-to-day management of the program.
If a lab testing shows a BAR, a BioWatch Advisory Committee meets to analyze the situation to decide whether the city should go to a full-scale response or if the BAR is due to naturally occurring bacteria in the environment that simply resembles the reading of a pathogen. The committee members include CDC and FBI officials, state and county health department directors, and DHS’s chief medical officer.
While the committee deliberates, the local resources of the public-health community are put on alert to look for symptoms of the suspected pathogen; law enforcement officials are sent out to investigate; and additional samples are taken from buildings in the area. The city has to handle the cost of these efforts.
There have been 149 BARs to date, and while none have been due to an actual bioattack, localities have been forced each time to take those costly precautions in the time between a BAR reading and a determination that no real risk exists. While the DHS does not consider this a false alarm, because technically there was a correct reading of a substance that later proved of no concern, others consider these false alarms, leading to criticism of how the system works.
Arthur Kellermann, a RAND analyst who served on the Institute of Medicine (IOM) committee that issued a report on BioWatch for Congress in 2009, says that during hearings for the IOM report, local public health officials said their cities’ public health funds were “devastated” whenever a BAR occurred.
These BAR readings can also cause trouble at large-scale events. In 2005, for example, several Washington, D.C. BioWatch detectors registered positive results during an anti-war protest on the National Mall. Public health officials had to make a tough decision in what the IOM refers to as a “high-regret action” situation. In this case, the choice was whether to evacuate the thousands at the Mall or take the chance that serious illness or worse could occur. After further investigation, officials decided not to evacuate the area, and fortunately, no one got sick.
Such alarms have also occurred during events such as the 2004 and 2008 Superbowls, the 2008 Democratic National Convention, and the 2006 National League Baseball playoffs. However, the DHS has said they are working to lower the incidence of unnecessary BARs, and there have been no alarms so far in 2013.
The high number of BARs might lead decision makers into what Kellermann calls the car alarm mind-set: “If you live in a neighborhood where a car alarm goes off every night, after two to three weeks, you just ignore it.”
But unnecessary alarms are only one problem.
Efforts have been underway for nine years to develop a way to automate the sample analysis—to have the analysis conducted within the same device that collects the sample—a “lab-in-a-box” approach that would not require human interaction, saving staff time and yielding results in six hours, versus the current 24 hours that it takes to get results from the lab. But as discussed in a June House Energy and Commerce Committee hearing, DHS officials have spent more than $300 million on various generations of this technology without success, including BioWatch Gen-2.5, which was deployed for two years until it was deemed ineffective, and Gen-3, which also was deemed to have failed in a first round of testing. But Brian Beaulac of Boeing, which works on Gen-3 installations for DHS, asserts that the technology and chemistry behind Gen-3 does work and that the system simply needs adjustments. BioWatch program manager Dr. Michael Walter made similar assertions at the congressional hearing. The DHS is expected to release a progress report on the new technology this fall.
After various investigations on BioWatch, including a 2011 National Academy of Sciences (NAS) report and a series of articles in the Los Angeles Times, legislators took notice of the program’s troubles. In 2012, the Senate and House Appropriation Committees removed the $40 million requested by DHS for Gen-3 and ruled that the experimental program may not receive further funding until the DHS certifies that the science involved in Gen-3 is proven. Both the House and the Senate committees have been looking into the program, as has the Government Accountability Office (GAO).
The aforementioned false alarm and technology issues were among the findings of these investigations. Another concern was the lack of coordination among all the players. “The BioWatch program appears to lack necessary coordination, communication, and collaboration among the several communicators at federal, state, and local levels that must be fully engaged for a functional system,” the NAS report states.
There has been a communication gap between the DHS and local public health officials since the beginning of BioWatch: the DHS has withheld information from local officials about the locations of BioWatch sensors in their own jurisdictions, and for years some local officials were unclear on the exact criteria of a BAR or how to respond. The lack of communication evolved into distrust between the two groups and weakened BAR response capabilities, the NAS report said.
Leadership turnover has also created confusion and made accountability elusive. During the House hearing on BioWatch in June, representatives grew frustrated with Dr. Walter, who was unable to discuss problems occurring before he came in 2009. When asked whether the first lab-in-a-box technology, Gen-2.5, had been pulled because it didn’t work, Walter said he did not know because that program predated him.
The DHS had also been charged with running an internal investigation on the program, but Walter said he didn’t know the results of the investigation or whether an investigation had taken place.
Last year, the GAO reported that the DHS did not develop critical knowledge before proceeding with the Gen-3 acquisition.
The agency began working on Gen-3 more than a year before completing key parts of the Acquisition Life-Cycle Framework, which is used to minimize waste and determine whether the DHS should move forward with proposed acquisitions.
BioWatch officials stated that they did not justify the necessity of Gen-3 or explore more cost-effective alternatives because there was already departmental consensus about the program, but Walter said they are addressing GAO’s concerns.
Steve Caldwell, director of homeland security and justice issues at the GAO, tells Security Management that Gen-3’s acquisition was rushed and incomplete. “We think part of that problem is not following good acquisition practices in terms of not coming up with good initial requirements, justifying the program, or analyzing alternatives, which they are doing now with hindsight,” Caldwell says. “Once you have those things in place, it’s developing reliable and complete estimates of performance schedules and costs, and trying to stick to those and hitting certain decision points to go forward when you have data, not just moving the program forward ahead of time.”
Although DHS says Gen-3 will greatly reduce detection time, experts doubt it will make much difference if other problems aren’t corrected.
The NAS report also revealed that local officials have little faith in the BioWatch program as a whole. “Some [local public health officials] stated to the committee that they would be unlikely to administer prophylaxis on the basis of a BAR alone, waiting instead until clinical cases occur before taking that step,” the report noted.
Overall value. The GAO’s Caldwell says that they do not question the overall value of a biosurveillance program, despite concerns with BioWatch. “It seems completely reasonable to us because we’ve got demonstrations of terrorists using that kind of thing, and we’re certainly not questioning the need for something that would be able to do some kind of monitoring in key places,” he states.
That view isn’t shared by everyone. Given that “we’re never going to have enough money to cover every possible contingency for every possible threat,” says Kellermann, this particular approach, which “addresses such a narrow piece of the threat space,” may not be the best use of limited resources.
Those funds may be better directed elsewhere, say others. For example, Rep. Tim Murphy (R-PA), speaking at the congressional hearing on the program, said “It makes no sense to expand outdoor monitoring for a less likely large-scale attack, while not addressing the declining number of public health responders who are needed in any kind of attack.”
Focusing on the core public health infrastructure and building capacity that would allow the country to respond to a much wider range of threats would be a better strategic choice, Kellermann says.
A 2009 Center for Strategic and International Studies paper reported that the U.S. response to bioterrorism overemphasizes detection and countermeasures at the expense of prevention and strengthening public health.
“Rebuilding the U.S. public health infrastructure would provide both better detection and better capability to treat the impacts of a biological attack, as well as improve surge capacity to deal with other mass casualty incidents,” the report states.
For example, implementing electronic medical records and digital links between hospitals and public health authorities would greatly enhance management in the event of a biological attack, says the report.
President Obama issued a National Strategy for Biosurveillance in July 2012 that mentioned strengthening local partnerships to improve BioWatch capabilities. However, the strategy does not include a framework to guide the systematic identification of risk, assessment of resources needed to address those risks, and the prioritization and allocation of investment across the entire enterprise, according to the GAO.
In his strategy, Obama also called for a strategic biosurveillance plan to be implemented within 120 days, but no such plan has been announced.
In August, the House Energy and Commerce Committee asked the GAO to do another report on Gen-3, which Caldwell says they plan to do. He also notes that there is no mention of Gen-3 in the 2014 budget, which means Gen-3 is in a holding pattern. However, the DHS recently extended the current BioWatch program in Washington, D.C., Baltimore, and Richmond with a six-month, $750,000 contract that funds the manual testing of the filters every 24 hours.
Meanwhile, Kellermann says that BioWatch is “in a league of its own,” both in stature and in number of skeptics.
“There’s so many levels of concerns about the technology and the premise that I think Congress’ skepticism and the experts’ skepticism is warranted,” Kellermann says. But he notes, “Part of what keeps programs like this alive is the concern that if we take it down and defund it, and then, God forbid, something happens in that narrow sliver of threat space, there will be hell to pay.”