Highlights from a Q&A with Greg Burel, former director of the Strategic National Stockpile

Why does the Strategic National Stockpile exist?: "The initial intention of the Strategic National Stockpile when it was founded in 1999 was to be prepared for potential problems related to, if you recall, Y2K and the concern about computers not working and people not being able to order things they needed and so on."

"The initial intention of the Strategic National Stockpile when it was founded in 1999 was to be prepared for potential problems related to, if you recall, Y2K and the concern about computers not working and people not being able to order things they needed and so on." Who decides what to purchase for the stockpile? "The formulary, that is, what is held in the Strategic National Stockpile, is determined by a multiagency governance body called the Public Health Emergency Medical Countermeasures Enterprise."

"The formulary, that is, what is held in the Strategic National Stockpile, is determined by a multiagency governance body called the Public Health Emergency Medical Countermeasures Enterprise." What's in the stockpile? "It's over an $8 billion — or was before this started going out — an $8 billion inventory of various materials including things like antibiotics, antitoxins, antidotes, vaccines, medical surgical material, federal medical stations you see, ventilators and other products."

Washington — The coronavirus pandemic has left states from coast-to-coast scrambling to secure ventilators for patients and masks, gloves and gowns for frontline workers as they confront a surge of patients battling COVID-19, the disease caused by the coronavirus.

In response to the deadly illness, which has claimed the lives of more than 11,000 in the U.S., according to Johns Hopkins University, which is tracking coronavirus statistics, the federal government has tapped into its stockpile of medical supplies, known as the Strategic National Stockpile, in an effort to bolster state capabilities.

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Many of the details surrounding the stockpile are kept secret, including its precise contents and the locations of strategically placed warehouses, though President Trump revealed Monday that there are 9,000 ventilators left in the national stockpile.

But Greg Burel, who served as the director of the Strategic National Stockpile for 12 years until his retirement in January, answered questions about the country's reserve, which stands at the ready, should the nation face a chemical, biological, radiological or nuclear attack, natural disaster or a pandemic.

When the Strategic National Stockpile was first started in 1999, what was the intention and ultimate goal for having massive amounts of different equipment?

Burel: The initial intention of the Strategic National Stockpile when it was founded in 1999 was to be prepared for potential problems related to, if you recall, Y2K and the concern about computers not working and people not being able to order things they needed and so on.

There was a tie with that to concern with that if a healthcare need arose because of equipment failure with computer systems and that there needed to be some backup of some kind of material that could be provided.

The next thing though to think about is most of that was considered in terms of chemical, biological, radiological and nuclear terrorism preparedness, because the concern was if something happened in that kind of a period, that would be a great time for a terrorist to try to attack you knowing that there would be all of these other issues that existed.

In the years since its start, has the function of the Strategic National Stockpile shifted?

Burel: The primary purpose of the Strategic National Stockpile is still and has always been to be prepared to respond to chemical, biological, radiological and nuclear (CBRM) events. We began to expand to more of an all-hazards mission over time because of the fact that we know some of the materials we hold for those purposes are useful in, say, natural events. We're also at the same time developing federal medical stations. When you see DHS and FEMA saying we're setting up these 250-bed temporary hospital things, those are SNS's federal medical stations they're setting up. All of those things were planned to be used if we had a CBRM event, but they are also useful obviously in any kind of natural event, whether it be a hurricane, flood, fire, pandemic, whatever.

In 2005, 2006, there were supplemental appropriations to be prepared for pandemic influenza. In 2009, the nation was struck with H1N1 pandemic influenza. So in response to H1N1 pandemic influenza, we deployed material that we had been stockpiling to respond to a pandemic influenza. The plan was to be prepared for a pandemic influenza event. We were, not as high a level as we would like, but we were prepared for pandemic influenza. Pandemic influenza struck, we moved a good portion of our materials forward to the states so they would have those available for pandemic influenza response.

At the same time, the states had been preparing in most cases for pandemic influenza themselves so many of the states at that time had their own pandemic stockpiles. It varied from state to state, some were large, some were small, some didn't have them at all. But in 2009, we were hit with pandemic influenza and we used that material.

Was the material ever replenished?

Burel: Unfortunately, we never received further appropriations designated to replace that material and the funds to replace that were never incorporated in our annual base appropriation. So our mission remains to be prepared for chemical, biological, radiological and nuclear events and we never received additional funding to cover more material for pandemic.

When you say more material for pandemic in particular, is that things like ventilators, vaccines, personal protective equipment?

Burel: You can't buy vaccines for a pandemic disease event because you don't know what the vaccine is going to be, and you know we're currently in this race to make the vaccine. So you couldn't have invested in vaccines had we wanted to. Ventilators also have requirements that relate to CBRN-type events, so we have continued to buy ventilators knowing they have multiple uses.

Some personal protective equipment have been purchased over the years because it's appropriate for other needs as well. But the massive amount that was projected for 1918-type pandemic influenza, 1. could never have been achieved with the supplemental appropriations that were received in '05 and '06, and 2., much of what we had was used in '09 and was never restocked to the level that it had been at that point.

Who oversees the stockpile and who decides what to purchase?

Burel: First, the Strategic National Stockpile is currently in the organization and is responsive under the organization structure of the Assistant Secretary for Preparedness and Response at HHS. Prior to that, it was under CDC. We moved to HHS in 2018, to be closer to the decision-making center about deployment and so on. It also allowed us to consolidate all of HHS material response capability in a single organizational line which I think made a lot of sense.

The formulary, that is, what is held in the Strategic National Stockpile, is determined by a multiagency governance body called the Public Health Emergency Medical Countermeasures Enterprise, and we shorten that as we do everything in government to PHEMCE.

PHEMCE is comprised of experts in various matters related to disease, drug development, device development, regulatory matters and so on from the Centers for Disease Control and Prevention, the Food and Drug Administration, the National institutes of Health, Dr. [Anthony] Fauci's NIAID, and then a number of other departments and agencies including DOD, VA, DHS and others. What the PHEMCE does is it looks at threat projections based on information from Department of Homeland Security. It works to model and consider what the event would look like around those threats that are identified by the DHS, and then we try to identify with the disease experts and the people who know way more about this than I ever will what are the most important things to keep in the stockpile.

There's always a longer list of things that we want to have than there is money to buy, so part of what the PHEMCE does is annually it does a review line item by line item of every product in the stockpile and what we need to spend to keep us at established goals based on models that predict what we would need.

As we try to work through the limited funds that are appropriated against the long list of things that we need, the PHEMCE makes recommendations to the secretary and the assistant secretary about what things are most important to buy.

In terms of what the stockpile looks like today and the supplies that have been compiled over the years based on this long list, what is in it?

Burel: It's over an $8 billion — or was before this started going out — an $8 billion inventory of various materials including things like antibiotics, antitoxins, antidotes, vaccines, medical surgical material, federal medical stations you see, ventilators and other products.

We never release the precise content of the stockpile or the numbers of each precise item in the stockpile because of the risks that would present in giving to a determined adversary a roadmap to, 'well they have this, so if I do this to them instead of that, I'm going to be more successful.'

Let's take it completely out of the realm of anything that we're prepared for so we don't disclose anything. But if you're prepared for the zombie apocalypse, you don't want to tell people how prepared you are for that because then they'll just say, 'instead of releasing the zombie agent on them, we'll release something else.' That's the risk of letting anybody know exactly what's in it and then the risk of letting anybody know exactly where it is is that that same determined adversary before they did something bad to us could say, 'well I know where it is so I'm going to take it out.'

You don't want somebody who wishes you ill-will to be able to destroy your capability to respond to whatever they're doing to do bad to you. You also don't want people whether they are ill-intentioned or well-intentioned to know where those locations are and suddenly show up there at the time we're trying to move material out of them, trying to get it for themselves or trying to interdict that material so we can't get it where it's going.

There are many risks involved in making the location of SNS material public. It would cause, I fear, an immediate failure.

I would imagine now that we are seeing this stockpile being very quickly depleted. How fast can it be replenished, especially in the midst of a nationwide event?

Burel: When you say being depleted, it is being depleted of materials that are important for this response, so there are things for other types of events obviously still there. To the question of how rapidly it can be replenished, it really is something you have to look at on a line item by line item by line item evaluation. …

What the Strategic National Stockpile has to do today is as it continues to acquire additional material, if those material are still being needed outside, and we've always planned for this, we can do several things. We can have suppliers to us take them immediately to where they need to be, dependent upon how many places they need to respond to. We can have them shipped to us and then we can further ship them out to places where they need to go, but what the Strategic National Stockpile I would guess is not doing today is ordering things and putting it on the shelf and not getting it where it needs to go. I would not expect that. That would not be what we are prepared to do.

What is the process for a state like California or Washington or New York to get supplies from the Strategic National Stockpile? Is it the first place they turn or supposed to be later on in the process?

Burel: When there is an event of any type, and this is the fact for all emergency responses in the United States, the federal government's responsibility is to begin to assist in response when state and local capabilities are exhausted. In this type of an event, what I would expect to see is that the medical supply chain should try to surge to meet the needs of the private-sector health care complex.

Secondly, states and locals who can invest monies that they have themselves from their own state budgets or from grant monies from the federal government — there have been a lot of public health preparedness grant monies and cooperative agreement funds that have gone to states in the last 10 years or so or more — they can invest that in buying and storing materials.

The point is that the way this should work is once the medical supply chain is exhausted, then those health care needs should flow up to the state. Once the state stocks, assuming that there are any, are exhausted, then they turn to the Strategic National Stockpile.

Normally the request process is a state makes a request through the secretary's operations center that's rapidly evaluated and responded to. In a nationwide pandemic event like this, we're still working on that same kind of a theory. We've worked with all the states for pandemic influenza planning and talked to them about this pro-rata approach so it's nothing new.

A chronic problem in public health preparedness is, and it's our chronic problem in emergency preparedness overall, the farther you move away from events that drive that preparedness in the minds of the public and in the mind of the Congress and the mind of the state legislature, it is less of a need to appropriate funds from limited available monies to plan.

I'm not necessarily criticizing the Congress or state legislatures for not doing that because there are many competing priorities for limited funds, but the reality is public health preparedness needs to be a priority and it needs to be routinely funded at a much higher level across the country than it has been for a long time, and then it would be better prepared to deal with these kinds of events.

In terms of supplies, how often is inventory checked to ensure vaccines and other materials haven't expired?

Burel: It's a continuous process. So when we consider what's in the stockpile, we run very large systems that we monitor daily so that we are aware of what is aging, where we stand in terms of needing to make new acquisitions to replace aging material so they can be rotated and so on.

The Strategic National Stockpile also participates in many programs to extend the useful life of our material. One of those is the Shelf Life Extension Program, which is an agreement between DOD and FDA that we ride along with DOD on, where certain drugs can be identified, they can be subject to a chemical assay, where very specialized scientists at the FDA can look at the review of the assay and say, 'yea this is still safe and effective for use and based on the data, we're going to let you extend the expiry date of this drug for x amount of time.'

For chemical drugs, we try to extend it through the Shelf Life Extension Program for the longest possible time that we can make that investment sound, and that means that in addition to looking at rotating things out, we're looking at things that have to go into the Shelf Life Extension Program for sampling and analysis and a determination from the FDA.

The other thing that we do is we do ongoing maintenance on durable medical equipment like ventilators. All of those get rotated back to their manufactures annually for preventative maintenance and all the necessary maintenance to make sure that they're still functional and operational.

As far as some of these medical devices like N95 masks and that kind of thing, there has been limited data available about how long you can use them after their expiry date. We've worked with NIOSH (National Institute for Occupational Safety and Hazard) over the last couple of years to try to study products that not just the SNS held, but that some states were still holding and that some other laboratories were holding old stock to test that stock and see if it was still safe and effective.

You may find on CDC's public-facing website ... data that NIOSH accumulated and studies they did that say those N95s that show an expired date are still safe and effective for use as long as the elastic doesn't break when you try to put it on.

What we try to do is extend the federal government's investments in all of those products as long as we can.

So even though states have said they received expired N95 masks, that doesn't necessarily mean they can't be used or that they're not as effective?

Burel: That is correct.

Is there anything further the general public should know about the Strategic National Stockpile?

Burel: What the general public should think about is that there is a strong need to fund public health at all levels, at the federal, state and local levels, and a part of that is the Strategic National Stockpile, but that's really only a part and pubic health needs advocacy at all levels to assure that it is funded in such a way that the public is protected.

This is not just a matter of whether people are getting sick, but it's actually a matter of national security and it needs to be take as seriously as funding the Department of Defense to be prepared for anything it needs to be prepared for.

Do you think the coronavirus pandemic could lead to a shift in the mindset of lawmakers to put public health front of mind?

Burel: As devastating as this event is, and I don't see this as silver lining or anything, but I hope that it makes some of the people that in the past have said public health preparedness is not as important as whatever will now look at this and say 'you know what, we should be allocating money for this, we should be thinking about this in a different way.'

Dr. Fauci has warned the coronavirus could be seasonal, is there anything Congress can do now to ensure the Strategic National Stockpile is ready in the future, especially as we await a vaccine?

Burel: Congress has appropriated supplemental funds to address this but what Congress must do from this point forward is look at making those supplemental funds not a once and done thing.

If we invest those supplemental funds today in new material to be prepared for a second wave of a next season event or whatever and we don't get that included in our base appropriations for long-term, we will not be able to maintain that preparedness just like the pandemic influenza.

I think there's another piece to this. With Dr. Fauci suggesting this may become a seasonal event, then the private supply chain is going to have to reconsider how it prepares, and I believe we must move away from a purely just-in-time inventory in the health care sector.

It's fantastic if I'm building a car and I don't want to store the parts and the parts arrive the day I build the car and the car comes off the line and I'm done. But health care doesn't work that way. We don't suddenly see the need to build 2,000 more cars than we do in one day on a normal basis, but we do see in health care and in public health the need often in a large outbreak to be able to respond to far more people than we would think we have to take care of.