A Crossroads in Biosecurity 

Tom Inglesby and Anita Cicero

This article is part of Crossroads in Biosecurity: Steps to Strengthen U.S. Preparedness, published by the Center for Biosecurity September 8, 2011 to mark the 10th anniversery of the 2001 anthrax attacks. Full document | Printable PDF

                
This fall marks the tenth anniversary of the anthrax attacks and the U.S. biosecurity community born in response. The shocking anthrax attacks in 2001 galvanized government and private sector action and put us on a determined path to reduce the dangers posed by biological threats. This is an appropriate moment for the community to consider the impressive distance that we’ve traveled since 2001, to understand the options ahead for biosecurity policy, and to map out priorities for future action at this 10-year point.

Before the anthrax attacks, few had seriously planned for such a biological threat, and there was certainly no tangible, multidisciplinary community devoted to improving biosecurity. There were no major government or nongovernment programs on biodefense beyond the DoD biodefense research programs and the anthrax vaccination program. There was no hospital preparedness effort and no CDC program to prepare states and local health departments. There was no NIH biodefense research initiative or FDA countermeasures initiative. There was no Pandemic and All- Hazards Preparedness Act, no ASPR, no BARDA, no BioShield fund. No DHS. Little sustained White House or Congressional attention to bioweapons or pandemic threats.

We Have Already Come Far

We have all those government initiatives now, and more. During the past 10 years, the U.S. government has established many efforts with missions related to improving biosecurity. As a result, substantial gains have been made in public health and hospital preparedness. Scientists have been provided billions of dollars to undertake fundamental research to improve biosecurity. A new FDA initiative is expressly focused on speeding up the regulatory process for necessary medicines and vaccines. There is major U.S. government interest in improving both domestic and international biosurveillance programs. Along the way, SARS, the concerns about avian influenza, and the 2009 H1N1 pandemic reinforced the importance of these programs.

The stakes related to the country’s biosecurity have been emphasized from the very top. In 2009, President Obama’s National Security Council said, “The effective dissemination of a lethal biological agent within an unprotected population could place at risk the lives of hundreds of thousands of people. The unmitigated consequences of such an event could overwhelm our public health capabilities, potentially causing an untold number of deaths. The economic cost could exceed $1 trillion for each such incident.”1

But We Still Have a Distance To Go

Despite this warning and despite the steady progress made since 2001, we have a long way to go. We do not have a public health workforce sufficient for recognizing or managing lethal infectious disease outbreaks: the U.S. public health workforce has been thinned substantially in the past few years as state and local budgets have been cut. Our burdensome laboratory security regimen is inadvertently creating barriers to progress in basic scientific research. We still have far too few of the medicines and vaccines we may need because the advanced development process has been slow and underfunded. Even if we had sufficient medical countermeasures, we do not have plans and reliable means to distribute them to people in the time needed to make a difference. Our hospitals do not yet have all the tools or plans they would need to take care of patients in a large infectious disease emergency. If there were not enough of a medicine or vaccine to go around, we do not yet have a plan for deciding who gets prioritized for treatment. In the event of a wide-area bioterror attack, there is uncertainty regarding how to conduct major decontamination efforts and whether mass evacuation should occur.

Renewed and Steady Determination

The reality now is that biosecurity is no longer benefiting from the collective, intense interest of political leaders or the funding commitments that followed the 2001 anthrax attacks. With the passage of time, the initial sense of urgency in efforts to shore up the nation’s biosecurity has waned, even as it is increasingly understood that advances in the biosciences over the past decade make biological weapons ever more accessible and technically feasible, and even with evidence that terrorist groups are interested in acquiring and using them.2,3

Immediate priorities of government have crowded out concern about biothreats over time. It is always a challenge in a democracy to plan for high-consequence, uncommon crises, and biosecurity is the archetype of this phenomenon. But there is no use in bemoaning this situation. At this crossroads of biosecurity on the tenth anniversary of the 2001 anthrax attacks, the biosecurity community (including both government and nongovernment leaders) should not accept the road of diminishing capacity, benign neglect, or gradually lowered expectations about the level of biosecurity that is achievable. We need to commit to tackling the nation’s biosecurity challenges in real and tangible ways during the decade ahead.

Suggestions for the Road Ahead

This compendium offers a series of pragmatic suggestions and goals that, if achieved, will move the nation forward on the road to biosecurity. The commentaries that follow offer specific recommendations regarding healthcare preparedness, community resilience, biosurveillance, laboratory security, and post-event remediation. To start, there are a number of proposed changes set forth below that, if made, would position the U.S. government to achieve more steady and efficient progress in the years ahead.

Stabilize and Prioritize Preparedness Investments

Proposed cuts this year include a reduction of more than $100 million or 15% to CDC preparedness grant funding, more than $40 million or 10% in cuts to hospital preparedness funding, and reductions of 35% to already limited EPA budgets for decontamination—cuts that will reduce funding for these 3 programs to their lowest levels since 2002.4 There has been little political penalty for cutting public health, hospital, and emergency preparedness investments. Leaders and the public should recognize that the great majority of the federal resources in these programs are used to protect people at home in states and cities. It is profoundly unwise to drop preparedness programs that have been built with federal investment and have been successful, but which will degrade without such support.

Increase Clarity and Transparency

We need greater clarity about the government’s medical countermeasure needs and decision-making processes. What diagnostics, medicines, and vaccines does the U.S. government now seek for the nation’s pharmaceutical stockpile? It has been more than 4 years since HHS, in its PHEMCE Implementation Plan for Chemical, Biological, Radiological and Nuclear Threats, provided a list of its near-term (FY07-08), mid-term (FY09-13), and long-term (FY14-23) goals for research, development, and acquisition of medical countermeasures. It is unclear whether the April 2007 list reflects current HHS priority requirements. Increased clarity in this area would improve the interaction between the government and private industry and allow assessment of overall progress. In addition, when decisions are made to purchase one or another vaccine or medicine, a detailed public rationale should be provided that explains the choice of medicine purchased, justifies the quantities, and explains how that countermeasure will be used operationally in time of crisis. This added level of transparency will help shield the process from undue political influence and will help the broader biosecurity community understand the tools at hand and how best to use them in the event of a crisis.

Build Congressional Expertise

In the words of the White House National Security Council, bioterrorism could place at risk the lives of hundreds of thousands of people. We believe there should be more energy directed toward biosecurity on the Hill. Just as there have been a number of Congressional members and staff who were nuclear specialists and were valued by the rest of the government for this expertise, there should be informed and committed staff members with specialized knowledge of biological threats. Right now, there are a few serious, expert, and effective Congressional leaders, but far too few for an issue of this potential consequence. Without attention to and deep knowledge about biosecurity programs, oversight has devolved too often into parochial interests.

Restore Responsible Budgeting

The recent changes in the way the federal budgeting process works has undermined important programs. Within the federal agencies, long-term program planning is nearly impossible when every year is funded via a continuing resolution. New priorities cannot be established, and course corrections are difficult to make. Exacerbating the effects of continuing resolutions is the recent mid-year slashing of agency funding. How are agency leaders supposed to manage programs with the constraints of such a system? And how is the private sector supposed to interact with a government that runs like this? The U.S. government should reestablish a clear, sensible, and predictable budget process.

Continue to Engage Civil Society

In the aftermath of an attack with a biological agent, or in the midst of a pandemic response, nongovernmental institutions and organizations will be crucial in determining the ultimate outcomes of those events. Government preparedness efforts have been far more inclusive of civil society over the years, with greater emphasis on resilience and involving the whole of the community. Both CDC and FEMA are providing communities with detailed guidelines for building broad coalitions for epidemic and disaster management, and this advice is welcome. What we need now is for leaders to step up and commit the personnel and resources needed to create and sustain these partnerships.

Stay Focused on the End Goals

Sometimes the details of building a government program obscure its larger purpose and the broader context. It is important to recall what we are seeking to achieve in biosecurity: the prevention of sudden large-scale deliberate or natural disease threats and, failing prevention, the capacity to save large numbers of lives and diminish the consequences of such events. This is honorable and critical work of government and its private sector partners. It is work to improve our country’s public health system and our national security. So when the barriers seem too high to overcome, and the easier path would be to stall out or avoid the challenges ahead, we need to remember why we are doing this work and press ahead.

Steps to Strengthen U.S. Preparedness

It is useful to recall the very real and urgent problems that our nation faced in the days and weeks following the 2001 attacks. In his commentary that follows, D. A. Henderson reflects on the anthrax crisis, recounts his experiences at HHS during that time and the programs that were launched in response, and identifies several important goals not yet achieved. In their commentaries, our other Center for Biosecurity colleagues provide a number of concrete recommendations to improve the country’s ability to prepare for, respond to, and recover from major biological events. Their suggestions embrace a wide range of imperatives that stress the need for sustained efforts to build hospital and healthcare system preparedness, create strong U.S. biosurveillance capacity, plan for wide-area decontamination, work through practical and legal issues related to crisis standards of care, implement prudent laboratory security, and build community resilience.

Many of the suggestions offered would cost relatively little but would result in substantial improvements in biosecurity. All of the goals are conceivably within reach in the years ahead. At this crossroad, they would help us move in the right direction— toward biosecurity.

References

1. National Security Council. National Strategy for Countering Biological Threats. November 2009; p. 1. http://www.whitehouse.gov/sites/ default/files/National_Strategy_for_Countering_BioThreats.pdf. Accessed August 24, 2011.

2. Statement for the Record on the Worldwide Threat Assessment of the U.S. Intelligence Community for the House Permanent Select Committee on Intelligence. Office of the Director of National Intelligence. February 10, 2011. http://dni.gov/testimonies/20110210_ testimony_clapper.pdf. Accessed August 10, 2011.

3. Norway killer wrote of anthrax attacks. Global Security Newswire July 27, 2011. http://www.globalsecuritynewswire.org/gsn/ nw_20110727_8719.php. Accessed August 10, 2011.

4. Franco C, Sell TK. Federal agency biodefense funding, FY2011–FY2012. Biosecur Bioterror 2011;9(2):117-137.