Relax about the Anthrax

July 27, 2015

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Deputy Secretary of Defense Bob Work held a late press brief on Thursday to announce the findings of a Department of Defense-sponsored investigative committee. Its job was to review the department’s laboratory processes that resulted in the inadvertent shipment of live Bacillus anthracis spores to 86 laboratories in eight nations, including the United States. Bacillus anthracis spores can cause the disease anthrax, which has a high mortality rate in exposed, untreated people. The highlights of the report focus on a review of laboratory processes within the four U.S. military labs that produced anthrax spores. As it turns out, half of the tested batches from Dugway Proving Ground had live spores in them, and investigators do not yet fully understand how the process failed.

The report did note that the gamma irradiation process — meant to kill live spores before they are shipped — was not at fault. The real problem was the post-irradiation viability testing, which was supposed to provide final verification that the spores were dead before they were shipped. The testing failed for some, but not all shipments. The report also notes that researchers do not fully understand how Bacillus anthracis can recover from radiation damage and continue to develop live cells. While the source of all of the live spores was from the Dugway lab, its procedures were not significantly different than the other three military laboratories. While the protocols did work at three of the four military labs, more quality assurance and quality control processes clearly should have been in place at Dugway.

The report states early in its executive summary that “it is critical for the department to have a strong countermeasures program to protect our warfighters against this dangerous organism.” Indeed, as Under Secretary Frank Kendall noted in the press brief, defense research using both live and inactive anthrax spores will continue. However, the Department of Defense did respond by issuing a moratorium against shipping any anthrax spores — live or dead — until more stringent protocols are developed and approved.

Of course, our intrepid news reporters wasted no time in asking the important questions: Why hasn’t anyone been fired? Is it true, as Noah Shachtman states, that the “death-by-gamma–ray process was never standardized or validated, and didn’t work”? How can we trust the Department of Defense to take appropriate steps to fix this issue if it does not yet understand what went wrong? In all the breathless coverage of this important issue, it’s hard to find anyone willing to consider the technical findings in the report or the policy implications of the department’s proposed actions. Science is hard, but we can start by saying that gamma irradiation is in fact widely accepted for sterilization, and the report notes that it continues to be the preferred method to inactivate anthrax spores.

Holding one person accountable is challenging since there is no one person in charge. There were six Army chemical officers (full disclosure: all of whom I know personally) acting as commanders at Dugway Proving Ground between 2003 and 2015. They were all superb leaders, hand-picked for what is considered a plum position within the Army Chemical Corps. No, they did not have PhDs. The Army stopped insisting that its Chemical Corps leaders possess hard science-based PhDs in their resumes in the late 1970s after the branch was nearly disestablished because it emphasized promoting technical expertise over combat leadership. One of those Dugway commanders is now a one-star general. Should we offer him as a sacrificial lamb for the sake of satisfying the general public that someone has been held accountable?

Or maybe we need someone higher up the chain. Maybe a general officer leading the Army Test and Evaluation Command should be cashiered — but again, if the shipments took place throughout 2003 to 2014, which one leader over the last decade bears the responsibility? All of them? What about the civilian leadership, one of the many Assistant Secretaries of the Army for Acquisition, Logistics and Technology who should have asked — given the post-9/11 emphasis on biological detection and medical countermeasures — what are the protocols addressing biological surety practices? How about the Office of the Secretary of Defense? With the oversight of the Chemical and Biological Defense Program lodged firmly under the Assistant Secretary of Defense for Nuclear, Chemical and Biological Defense Programs, maybe we need to ask Mr. Andy Weber what he knew and when he knew about the biodefense program’s techniques and practices?

As you can hopefully understand, it becomes a ridiculous charade to try to pin responsibility on one person or one agency. The investigative report properly notes that protocols were in place that were validated, approved, and then followed. The Centers for Disease Control (CDC) and the Army Inspector General have traveled to Dugway many times to review and approve the lab’s protocols. This is a fixable problem — a problem intrinsic to science. We learn from trial and error. This is called “experimentation.” Academia, private industry, and government research all have these issues.

Additionally, journalists covering this story have generally overlooked role of CDC in this incident. The CDC is required by law to oversee the inspection of entities to evaluate whether they meet federal regulatory requirements regarding the shipment of select agents and toxins. No one has asked the tough question about why the CDC has not yet recommended a standard protocol for the shipment of inactivated biological organisms. Given that it has been more than a decade since the Amerithrax attacks, more progress should have been made in this area.

On to the next question: Why should anyone trust the Department of Defense to fix this issue? One might start out by reading the list of the members of the review panel at the end of the report. Of the twenty committee members, only two were from the Department of Defense. There is no bias in selection, just an excess of scientific minds and a dearth of policy wonks. No one is going to shut Dugway down — it is a national treasure. The Department of Defense cannot verify and validate that our military’s chemical biological defense gear will work in the field without using Dugway’s unique testing facilities.

The report identifies some detailed corrective actions in its recommendations, including improving quality assurance efforts, instituting a peer review process, and encouraging better program management of the inactivation process. The Department of Defense will not allow any shipments until a formal implementation plan is developed and instituted, a formal investigation on the specific actions is conducted, and a new overlord appointed to implement the recommendations. Most of these recommendations are sound and should be implemented.

While the recommendations are mostly useful, two significant misfires are included. First, the report calls for the Department of Defense’s Chemical and Biological Defense Program to fund the research required to develop standardized irradiation and viability testing protocols. The Chemical and Biological Defense Program is a management function run by the Office of the Secretary of Defense (OSD) to procure defense equipment for the military. Over the past five years, it has diverted funds from equipment development to paying for Army infrastructure bills associated with chemical and biological defense research and development. Maintaining laboratory buildings and equipping these buildings is appropriately an Army installation management responsibility, but budget pressures have caused the Army leadership to try to convince OSD to pay for its operations and maintenance bills. This problematic practice needs to be addressed.

Second, Frank Kendall’s memo calls for the Army to become a Department of Defense Executive Agent for the Biological Select Agent and Toxin Biosafety Program, adding to the list of 40 other DoD Executive Agent roles that the Army maintains. The Army has been the Executive Agent for Chemical and Biological Defense since 1976, and this new responsibility is really a subset of that existing one. The department does not have to do anything more than tell the Army to execute its existing responsibilities. Adding a repetitious and meaningless title won’t add value to the existing regulations on Army biosurety.

In addition, the Army’s track record as DoD Executive Agent for Chemical and Biological Defense is not promising. Over the past decade, senior Army leaders have repeatedly avoided confrontations as OSD senior leaders made very bad decisions affecting the development of military chemical and biological defense capabilities. While the Army owns the overwhelming majority of technical agencies and has some truly talented civilians and contractors in its ranks, the corporate Army does not view chemical and biological defense or countering weapons of mass destruction as a priority among other critical defense issues. If the Army wants to respond to these issues and challenges, it needs to be serious about consistent, strong leadership, and begin looking at the strategic context and not just merely inward.

Like every other investigation, this will blow over and the Army will get back to work. The investigation does come with a cost, as Dugway’s important work is sidetracked and blanketed in investigations. Critically, the larger context here requires examination: What does the U.S. government consider “countering WMD” and how does the “whole of government” support that mission? Do we lack the clear and concise guidance required to manage the many conflicting agendas and programs that involve WMD? How do we ensure that the U.S. government adequately oversees the development of protective capabilities for facing WMD threats in major combat operations, irregular warfare operations, and homeland security? We have a limited set of technical experts and a lot of responsibilities assigned to them. The need for policy leadership in this area is constant and unrelenting.

 

Al Mauroni is the Director of the U.S. Air Force Center for Unconventional Weapons Studies. The opinions, conclusions, and recommendations expressed or implied within are those of the author and do not necessarily reflect the views of the Air University, U.S. Air Force, or Department of Defense.

 

Photo credit: push0k

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5 thoughts on “Relax about the Anthrax

  1. You need to read the review report before spouting nonsense (such as the flatly false–appallingly ignorant or brazenly dishonest–statement that the “report properly notes that protocols were in place that were validated, approved, and then followed”)

    If you lack the high-school-level math, analytical skills,a and reading skills to understand Figure 2, Appendix B, and the conclusion “DoD routinely operates outside validated experimental data for kill curves,” then get someone on your staff to help you out.

    1. Dr. Ebright – your viseral attacks against Dugway, well publicized in The Daily Beast and USAToday, tend to obscure rather than reveal the problem here. I understand your opinion that there are too many bio research labs doing too much work on bio warfare agents. But your insistence that DPG didn’t have validated protocols is not so easily understood. You might sneer at their having contractor staff, but they are still PhDs and doing the work that has been reviewed by the CDC and DA IG. Of course, you don’t like the CDC’s handling of inactivated anthrax either.

      Instead of focusing inwardly on the graphs, maybe you should read the review’s findings and recommendations. The twenty reviewers, most of whom were not DoD, didn’t say “shut down Dugway” and they didn’t say the protocols were bad. They need to fix some of their testing and then their work can continue. As a scientist, you should be able to understand that. This work needs to go on and it will go on, because we need the biodefense countermeasures and they need anthrax spores for validating their performance.

      1. “Instead of focusing inwardly on the graphs, maybe you should read the review’s findings and recommendations.”

        No, no. As a scientist myself, I think it’s important we concern ourselves with the evidence. Discouraging that says, a lot about your place in this conversation.

  2. The author states, “As you can hopefully understand, it becomes a ridiculous charade to try to pin responsibility on one person or one agency. ”

    which may be true, but it doesn’t make this any more palatable. Some of the problems with large bureaucracies such as many military commands are that responsibility is so difused that it is impossible to pin blame on any one person, coupled with that it is impossible to measure whether any given employee is actually efficient and effective.

    Most commanders and program managers, are in a position for such a short time that they never really have a grasp of everything going on in their command/PMO. (Most PMs don’t even stay the minimum required of DAWIA tenure agreements (the next milestone) – I’ve seen PMs pulled out of their “command” early to go to war college or even just to be someone’s O-6 chief of staff). The military’s bureaucratic promotion policies under DOPMA require officer’s to flit from one position to the next without ever becoming rexperts in anything.

    Perhaps a solution is to assign responsibility for critical tasks to clearly identified individuals with tenure agreements.

    1. Agreed,”Some Dude” – the Army Acquisition Corps needs somme fine-tuning. Hard to have a short-term (1-2 year) PM take responsibility for a 10-15 year defense R&D program. That’s why it’s my hope that the Army takes its Executive Agent role more seriously and starts taking charge of the chem-bio defense program, and tells its own story about what needs to be done in this field. There does need to be more accountability, but the GOs and SESs in ASA(ALT) have to lead and champion the CBD program first.