​Winter 2017

In 2015 and 2016, the emerging threats were infectious diseases, but the next threat could be a chemical spill, radiological event or natural disaster. Without a source of comprehensive funding for all potential threats, the health of the American public cannot be adequately protected.

Lab Matters Winter 2017

byNancy Maddox, MPH, writer and Gynene Sullivan, MA, CAPM, senior specialist, Communications

“Sometimes you run into such really difficult situations,” said Mike Pentella, PhD, recalling his work during the 2009 infuenza A (H1N1) pandemic that killed roughly 12,000 US residents and sickened about 60 million more. At the time, Pentella was overseeing disease control activities at the State Hygienic Laboratory at the University of Iowa.

He said, “Here we are just a few days into this outbreak and we have a non-typeable infuenza virus, and I needed to send it to the US Centers for Disease Control and Prevention (CDC) [for analysis]. It was on a Saturday too.”

The cost for a courier to transport the infectious disease sample to Atlanta? $5,000.

Ultimately, the influenza isolate did make its way to CDC in timely fashion, but only because the agency sent its own courier to collect it. “And it did turn out to be the outbreak strain,” said Pentella. “If they hadn’t helped out in that  situation—myself not having those kinds of dollars [in my budget]—we would have been delayed in knowing we had H1N1 in Iowa. ... I really appreciated CDC that day.”

This concern, among others, has driven bipartisan efforts to establish a permanent, federal fund for public health emergencies: immediately accessible money that can be tapped to bridge the gap between the onset of a public health crisis and appropriation of supplemental federal funding.

What happens in the early days of a crisis, said Scott Becker, MS, executive director of APHL, will influence how it unfolds: “If you can control [the problem] while it’s an ember, you can prevent the wildfire.”

Just last year, for example, a different microbe was threatening the United States: Zika, a mosquito-borne virus capable of causing devastating neurological birth defects in babies born to infected women. By August 2016, well over 150,000 cases had been reported in the southern Americas—including over 5,000 in Puerto Rico—and the very first cases of local transmission in the continental US were documented in Florida.

Andy Cannons, PhD, HCLD(ABB), director of the Florida Bureau of Public Health Laboratories–Tampa, said that once local transmission was confirmed in the state, Florida laboratorians worked overtime to test thousands of specimens via genomic and antibody assays. Cannons said, “It would have helped to have more (genomic) extraction robots to free up staff and more plate washers and plate readers (for antibody testing). We were super busy.”

Bridging from Threat Onset to Response

The concept of setting aside public health monies that can be accessed without special Congressional action is nothing new. In fact, the US Congress did just that in 1983, when it created the Public Health Emergency Fund (PHEF).

Jim Blumenstock, senior director for health security at the Association of State and Territorial Health Officials (ASTHO), said this fund wasn’t prompted by any one crisis, but by a multitude of events that “pushed the nation’s public health system to its limit,” including the 1976 swine flu outbreak, the partial meltdown of Pennsylvania’s Three Mile Island Nuclear Generating Station in 1979, the intentional contamination of Tylenol® acetaminophen capsules with deadly potassium cyanide in 1982, and a number of foodborne disease outbreaks.

Said Blumenstock, “There are consequences to moving money around from one priority to another. Congress realized that’s not in the best interest of protecting our citizens, and this fund was a good alternative.”

The challenge with using PHEF as a “bridge fund” has been that in some years it received minimal funding, and in other years, none. The most recent efforts to fund PHEF, or create a new fund that addressed PHEF’s shortcomings, came in 2016 through the Public Health Emergency Preparedness Act (HR 4525), the Public Health Emergency Response and Accountability Act (S 3280) and the Centers for Disease Control and Prevention Emergency Response Act of 2016 (S 3302). All three bills died in committee.

The Infectious Diseases Rapid Response Reserve Fund proposed in the FY 2017 House appropriations bill is the latest effort. As detailed in that bill (HR 5926, Sec. 231), Congress may appropriate up to $300 million for use by CDC when the secretary of the Department of Health and Human Services declares an infectious disease emergency or determines that such an emergency has  “significant potential to imminently occur” and, upon occurrence, potential  “to affect national security or the health and security of United States citizens, domestically or internationally.” Similar efforts for emergency response funds for chemical and other types of responses have also been proffered for legislative review.

Though these efforts represent a step forward, they fail to deliver support  for the full range of public health threats. And public health threats are unpredictable. In 2015 and 2016, the emerging threats were infectious diseases, but the next threat could be a chemical spill, radiological event or natural disaster. Without a source of comprehensive funding for all potential threats, the health of the American public cannot be adequately protected.

New Threats + Erosion of Public Health System = Perfect Storm

Indeed, the current effort to establish an emergency response fund comes at an especially difficult time for health agencies. Not only is the threat environment more challenging now than in the 1980s, but the public health system has yet to recover from more than a decade of underfunding.

According to the Trust for America's Health (TFAH), between FY 2002 and FY 2016 state public health emergency preparedness funding was slashed from $940 million to $660 million—a one-third reduction. In addition, said Blumenstock, the recession of the early 21st Century led to the loss of  “thousands of state public health positions.” The emergence of new threats combined with the erosion of the public health system, he said, is a “perfect storm.”

The difference between the response to H1N1 influenza in 2009 and Zika virus in 2016 boils down to timing. In 2005-2006, because of the threat of bird flu and SARS, a lot of money was put into pandemic preparedness, so there were resources already available for surge testing and other laboratory needs. When cases of the virus started showing up in the US in April 2009, the public health system was ready. The Zika epidemic, in contrast, was unexpected and came on the heels of a massive West African Ebola outbreak for which Congress had appropriated  $1.77 billion to be spent over five years (1) extinguishing the Ebola epidemic at its source, (2) supporting immediate and decisive response to any US cases and (3) preparing for and responding to disease threats around the world.

In April 2016, as a stopgap measure, the administration shifted $510 million from Ebola response to Zika initiatives, including vaccine research, mosquito control and aid to hard-hit Puerto Rico. At the same time, the Department of Health and Human Services and the Office of Management and Budget redirected an additional $44.25 million from state and local Public Health Emergency Preparedness (PHEP) cooperative agreements (which are awarded to the 50 states, four metropolitan areas and eight US territories and freely associated states) to support the federal Zika response.

But by many measures, that strategy backfired.

According to two complementary surveys—one conducted by the National Association of County & City Health Ofÿcials (NACCHO) and the other conducted jointly by APHL, ASTHO and the Council of State and Territorial Epidemiologists (CSTE)—many state and local health agencies now report being less prepared to deal with potential public health  emergencies, including Zika virus, as a result of the shifting of funds from annual preparedness activities to Zika-specific activities.

Among the findings:

  • 94% of the 349 local health department respondents reported receiving PHEP funding through their state or territorial health agency. Half reported that PHEP cuts have had some or significant adverse impact on their community’s Zika preparedness and response.
  • Of the 61 responding direct PHEP awardees, 89% reported that cuts have had an adverse impact on general pre-event readiness, including staff training, emergency response exercises, community outreach, etc. Specific impacts on awardees’ public health laboratories include new constraints on equipment purchase, equipment maintenance, laboratory staffing and staff training. (Between FY 2012 and FY 2014, PHEP awardees dedicated a combined average of $77 million each ÿscal year to biological and chemical laboratory preparedness.)
  • The 61 PHEP awardees reported the combined loss of over 200 full time equivalents (FTEs), and 60% reported a negative impact on Zika preparedness and response in their jurisdictions.

Even though the $44.25 million in PHEP funds was later restored, the cuts will have a lasting effect. Said Rich Hamburg, MPA, executive vice president of TFAH, “You lose capacity when there’s unpredictability. You just can’t rehire staff.”

As one NACCHO survey respondent commented, “Public health depends on grants to sustain activities. If grants are cut, that activity goes away. ... This puts our entire population at risk.”

Early Intervention: More Effective—and Less Costly

The importance of immediately accessible, comprehensive surge funding cannot be overstated. As the last three big public health events demonstrate, responders cannot count on the ready availability of emergency appropriations: the time between activation of CDC’s Emergency Operations Center and Congressional appropriation of supplemental funding was just over 60 days for H1N1, about 160 days for Ebola and roughly 220 days for Zika virus.

In contrast, public health interventions tend to be more effective—and less costly—when they occur swiftly. In the absence of “bridge funding” and easily scalable procurement systems, public health officials are left to fend for their communities the best they can when crises arise.

Already, Pentella, who until recently headed the Massachusetts Public Health Laboratory, said his staff has developed eight new Zika-related assays and tested over 4,000 potential Zika specimens.

He said, “It’s a lot of work, really a lot of work. ... We could use some additional people and we can’t hire them because we don’t have the money, so it’s just added to everyone’s workload. ... Maybe we were [going to] do some test development or something else beneficial to public health, but we can’t—you have to attend to the outbreak, always. We have felt really pushed and very concerned about where the dollars are coming from.”

Senator Roy Blunt (R-MO) asked during the Zika appropriations hearings if there were a way to enable authorities to “prevent some emergencies and be even better positioned to respond to others.” All of those interviewed for this article agree that a rapid response funding mechanism is a key part of the answer.

Said Blumenstock, “We are having the exact same conversation and challenges today as Congress tried to address 35 years ago. The need never waned, and I would argue the demand is much greater now.”