The Trump Administration is being heavily criticized for their reactive response to the COVID-19 virus.  In response, President Trump has continually blamed the Obama Administration for leaving “empty shelves” in the nation’s Strategic National Stockpile (SNS).  Others can determine the truth of that statement but what is true is that in 2018 the Trump Administration published a detailed, proactive strategic plan to deal with a potential pandemic.  Published by the National Security Council (NSC), the “National Biodefense Strategy of the United States 2018”[1] created  five goals with associated objectives for “….strengthening the biodefense enterprise, establishing a layered risk management approach to countering biological threats and incidents”.  The overall strategy:

“… describes the goals and objectives that will guide the United States in assessing, preventing, detecting, preparing for, responding to, and recovering from a biological incident, consistent with its international obligations, including those identified in the World Health Organization’s International Health Regulations (2005)”.

This strategic plan identified five goals:

Goal 1: Enable Risk Awareness to Inform Decision-making Across the Biodefense Enterprise.

Goal 2: Ensure Biodefense Enterprise Capabilities to Prevent Bioincidents.

Goal 3: Ensure Biodefense Enterprise Preparedness to Reduce the Impacts of Bioincidents.

Goal 4: Rapidly Respond to Limit the Impacts of Bioincidents.

Goal 5: Facilitate Recovery to Restore the Community, the Economy, and the Environment After a Bioincident.

The plan and these goals would have served as initiating documents to authorize projects to address and recommend solutions for each goal.  The strategy goes onto say:

“the National Security Presidential Memorandum (NSPM ) that accompanies the issuance of this National Biodefense Strategy creates a dedicated mechanism, housed within the U.S. Department of Health and Human Services, to coordinate federal biodefense activities and assess the effectiveness with which the National Biodefense Strategy’s goals and objectives are being met. Led by the President of the United States and coordinated by the National Security Council staff in the Executive Office of the President, with day-to-day coordination and execution by the Secretary of Health and Human Services, this mechanism will continually assess how effectively the objectives of the National Biodefense Strategy are being met.”

 

A chain of command, led by President Trump, was designated to hold government agencies accountable to address and respond to these goals.  Project management best practices state that proactive responses save money, save time, lead to better products and when applied to a pandemic, would save lives!  Clearly the administration intended to initiate projects to enhance our preparedness.  But were these project’s initiated?  Were they funded?

At the BioDefense Summit in April 2019, Timothy A. Morrison, Special Asst. to the President and Sr. Director for WMD and Biodefense at the National Security Council (NSC) re-iterated these goals[2].

More needs to be investigated about the government’s work after the release of the National Biodefense Strategy of 2018.    Digging deeper into this strategic plan raises a disturbing number of questions.  Many of the activities that needed to be addressed proactively are now being handled in a reactive manner.

Some of the goals and objectives are summarized below followed by my comments.

Goal 1: Enable Risk Awareness to Inform Decision-Making Across the Biodefense Enterprise

Ensure decision making is informed by intelligence, forecasting, and risk assessment. Assess the risks posed by research, such as potential pandemic pathogens, where biosafety lapses could have very high consequences.

Comment: Clearly the government was concerned that an accident could occur allowing pandemic pathogens to be released into society.  What proactive steps were taken to mitigate this risk?  Did we have any proactive influence with China?

Assess the potential impacts of bioincidents on critical infrastructure and supply chains, and how disruption of these systems might affect the ability to respond to bioincidents.

Comment: The medical community is living this right now!  Supply chains for ventilators, ventilator parts, swabs, and other medical items to support testing is in disarray causing states to compete for PPEs.  The government recognized in 2018 that a pandemic would severely impact supply chains and had no proactive response forcing states to compete and hospitals to innovate in a reactive manner. This goal was not addressed.

Ensure that domestic and international biosurveillance and information-sharing systems are coordinated and are capable of timely bioincident prevention, detection, assessment, response, and recovery. Strengthen foreign governments’ and international bodies’ capability and commitment to identify, characterize, and report biothreats and bioincidents rapidly and transparently.

Comment: China is a closed, communist, totalitarian government and expecting them to be  completely transparent is asking too much. But, what actions were taken to strengthen China’s interest in full transparency?  Did trade wars and other negative rhetoric from the President contribute to China’s lack of transparency?

Goal 3: Ensure Biodefense Enterprise Preparedness to Reduce the Impacts of Bioincidents

Develop, exercise, and update prevention, response, and recovery plans and capabilities and support the effective deployment of the medical countermeasures (MCM) stockpiles.

Comment: These MCM include pharmaceutical products, such as vaccines, antimicrobials, and antitoxins, and non-pharmaceutical products, such as ventilators, diagnostic tests, personal protective equipment, and patient decontamination materials, that may be used to prevent, mitigate, or treat the adverse health effects from a bioincident. This goal implies that policies and plans would be developed and that exercises or simulation activities would be conducted to “test” these plans.  These plans would implement and support surge capabilities across response sectors in coordination with state, local, tribal, and territorial (SLTT) entities.  Was such a plan developed?  Were tests or simulated exercises conducted?

This goal was not addressed and MCM stockpiles were not effectively deployed causing the administration to respond in a completely reactive manner. Again, states were forced to compete for PPE and, in the case of Maryland, even purchase needed supplies from South Korea.

Enhance preparedness to save lives through MCMs, improve diagnostic capabilities and maintain a core capability to develop, produce, and refine diagnostic tests rapidly to meet the outbreak response needs.

Identify additional incentive mechanisms to engage MCM developers and stimulate private sector investment and innovation across the range of the MCM technology base.

Comment: To date, the administration still cannot respond rapidly to meet the testing needs of the country. Many segments in our society are opening without clearly understanding the infection rate of their community.  This is having a severe impact on the health of the nation and adding undue risk as the economy opens in many states.

Was private industry ever contacted before the pandemic and encouraged to invest and innovate?  Was it economically feasible for corporate investment?  If there was participation, who invested and how did they invest?

Goal 4: Rapidly Respond to Limit the Impacts of Bioincidents

 – Enhance situational awareness through real-time, incident information sharing. Provide timely information to domestic and international stakeholders regarding utilization of border measures, prioritization of MCM dispensing, epidemiological control measures, and re-occupation of decontaminated areas.

Comment: It seems that in the first 30-45 days of the pandemic there was little MCM to prioritize and dispense.  Was a project initiated to create an approach to prioritize and distribute MCMs?  Where was the playbook?

Conduct federal response operations and activities in coordination with relevant non-federal actors to contain, control, and to rapidly mitigate impacts of biothreats or bioincidents. Deploy MCMs and implement community mitigation measures (CMMs)

Comment: Community Mitigation Measures (CMMs) are behaviors or actions that people and communities can take to help slow the spread of biological hazard, to include threat-appropriate travel and border health measures.  Much like the previous goal, the administration did not seem to follow any playbook to deploy PPEs, ventilators, and CMMs.

According to the Washington Post, “HHS Secretary Alex Azar responded to concerns that a there was a “startling shortage” of essential medical supplies (masks, gowns, gloves, etc.) and wrote letters in late January and early February asking for additional funding.  Since China also needed such supplies, replenishing them could be difficult as much of the manufacturing was in China. He also made a formal request for $4 billion on February 5, which “OMB officials and others at the White House greeted as an outrage”. Congress later increased the figure to $8 billion, and Trump signed it into law on March 6, but this delay meant that the U.S. would increasingly compete with other nations for such supplies”[3].

The administration should have addressed this problem well before the pandemic outbreak.  Outraged?  Why were we competing for supplies with other nations when the strategic plan mandated it be addressed back in 2018!

To be clear and fair, The National Biodefense Strategy of 2018 is an exceptional strategic document.  But it’s just that, “strategic” not “tactical”.  In project management it would equate to a Business Document or even a Project Charter because it defines the high-level goals and objectives of the subsequent project(s) that must follow.  These goals and the details under them should have immediately turned into project work to create policies, plans, simulate pandemic events, and fill the national stockpile. These projects would have created tactical, proactive approaches to deal with an incoming pandemic that most experts say was imminent.

At the very minimum, had project management best practices been followed, front line care givers would have had PPEs.  Proven and tested processes and procedures would have been documented in a playbook for execution in early January.  Did these projects happen?  Were they funded?

 

 

[1] https://www.whitehouse.gov/wp-content/uploads/2018/09/National-Biodefense-Strategy.pdf

[2] https://www.phe.gov/Preparedness/biodefense-strategy/Pages/advancing-biodefense-transcript.aspx?utm_source=hs_email&utm_medium=email&_hsenc=p2ANqtz-_8Hg4TjJVXLtB3OrypFvb3AyMvd1_sjbqt1dLoYzi9lUQu-T8HKxO4rWzSKfcKDqkO1_lK

[3] “The U.S. was beset by denial and dysfunction as the coronavirus raged”. April 4, 2020 – via washingtonpost.com.