From the U.S. Government Accountability Office, www.gao.gov

Transcript for: Pandemic Preparedness: Watchdog Report Deep Dig Edition

Description: As the nation contends with the spread of a coronavirus, we
sat down with GAO experts to talk about the government's preparation
efforts for a pandemic.

Released: March 2020

[ Background Music ]

[Matt Oldham:] Please keep in mind this podcast was recorded on March
10th and 11th, so there's a good chance there will have been changes to
some of the facts and figures by the time you hear it. Coronavirus is
here in the United States. And people would like to know what the
government has done to prepare, and what we can expect from federal
agencies as the disease will likely spread further. Welcome to this Deep
Dig Edition of the Watchdog Report, where we focus on larger issues.
We're going to hear from the people behind the work at GAO, their
efforts and their experiences. You know, things we could dig deeper on.
And this episode is all about pandemic preparedness and the nation's
biodefense strategy.And here to talk with me are GAO experts Mary
Denigan-Macauley, Chris Currie, and Tim Persons. Before we get to the
work GAO has done in this area, and in light of the current coronavirus
outbreak, Mary, what's the government been doing up to now?

[Mary Denigan-Macauley:] Importantly, they passed a supplemental
package, which will help us to get the appropriate funds for
surveillance, so we can continue to monitor how much it's spreading here
in the United States. It's going to help with state and local Public
Health officials to get up to speed as well, and diagnostic testing is
incredibly important. 

[Matt Oldham:] Chris?

[Chris Currie:] I would agree. I think the government does plan for
these types of things, there have been different agencies like
Department of Homeland Security and Health and Human Services have
developed specific pandemic planning. And they've done exercises, so
certainly a lot of the things that they've learned and are spelled out
in that, an those documents are being executed right now. I think what's
unique about this case as compared to what's happened in recent years,
there hasn't been a large domestic outbreak like this in quite a while,
really since like H1N1 in 2009. So, that definitely makes this
particular outbreak different, and I think is leading to the, some of
the scarier things that we're seeing and hearing about, or worried about
as compared to like Ebola a couple of years ago, or Zika where most of
those situations were offshore.

[Matt Oldham:] So, Tim, you've worked on a recent report that was
specifically on coronavirus, a spotlight. How prepared was the
government to respond to this outbreak of coronavirus based on past GAO
work?

[Tim Persons:] I think that the past lessons that we had from our work
of course, as Chris and Mary are pointing out, there's a preparedness
element of that. Hindsight is 2020 as they say, and so, I think our past
work looking at other pandemics in the past, the H1N1 and so on, the
H3N2, the SARS, or these other outbreaks, not necessarily pandemics, but
they have -- each time we have to face this, we essentially gain new
insights into how, or where, we are lacking. And so, all the
preparedness dimensions of that, the need for advanced research and
development. A -- the, really I think an upgrade in to sort of an agile
pan-governmental operational tempo, right? Even just within the
Department of Health and Human Services, you have all these incredible
and important elements and functions going on there. Whether it's
research at the National Institutes of Health that's, under which part
of our vaccine development works under that domain. But, then you also
have to run through the regulatory process, because if you're going to
start to imagine developing a vaccine quickly, you still want to test it
because you want your vaccine to be safe.

[Matt Oldham:] So, what are some of the challenges the federal agencies
face either within this government-wide approach or as individual
agencies?

[Tim Persons:] Coordination is easy to say and hard to do. I mean,
there's legal authorities and functions, and uniqueness of all of them.
And again, this is, I can speak just within the domain of the Department
of Health and Human Services, and the coordination between itself is a
challenge, much less is you start saying, well, let's involve so many of
our service member overseas, and they're, that's a Department of Defense
issue. All right, there's so many in Homeland Security, the folks
securing our borders or they're doing screening at the airports and
things like that. So, that's a Department of Homeland Security function.
And State Department, in terms of international relations there's all of
this sort of, this crosscutting broad view I think is, are a part of the
challenges. And then, with, in each of those challenges, each one of
those entities has their challenges in their way. If you're screening
let's say at the border or airport checkpoints, and you're trying to
see, you know, can you detect in a non-intrusive, noninvasive way that
doesn't slow or shut, practically shut down the transit systems, so that
you can screen for potentially infected people or try and quarantine
them, you know, implement safeguards and things like that.

[Matt Oldham:] So, what can we expect to see next from the government?

[Chris Currie:] I think the key right now is testing. You know, I mean,
we have to get a handle on how many cases there are and how fast this is
spreading. I don't think anybody knows that right now. We still don't
have good numbers on the virulence and the mortality rate for this
disease. There's a lot of guessing going on and a lot of projecting
going on based on the cases that there are overseas. But, I think even
the information from overseas, we're not ever sure that's reliable now.
So, I think one of the biggest steps right now is just trying to figure
out how bad this is. And that makes it extremely difficult to know what
concrete actions to take. So, like when you start talking about
quarantining populations, or closing schools, or restricting domestic
travel, it's very difficult to make those kinds of decisions with
incomplete information.

[Matt Oldham:] Well, then that begs the question and points to GAO's
past work, were government agencies prepared for this?

[Mary Denigan-Macauley:] We're a lot better prepared now after the H5N1
back in 2005 time period. The federal government has taken an active
role in preparing for a pandemic being able to move forward with the
telework and et cetera, things like that. So, there's no question that
we're in a better position now, and Health and Human Services takes the
lead when it's a public health or medical response. And they have been
working closely with FEMA and with the local and state, and even with
USDA, for example, if it's an infectious disease outbreak that also
involves animals. So, our past work has shown that, that coordination
has gone on and we'll continue to work, so we've laid the foundation for
that.

[Chris Curie:] And I would agree with that. I think the thing that's so
unique about biological events though, is unlike cyberattacks or natural
disasters, they just don't happen every month or every year. So, it's
incredibly difficult to, you can exercise these things and develop
plans, but it's just really difficult to know how to handle these things
operationally if you don't have a real-world event very often.
Particularly one domestically where there's a big spread and it's just
not a, sort of a vague offshore threat.

[Mary Denigan-Macauley:] That does lead to the fact that the exercises
are absolutely key, because you have to know who your partners are, so
that you're not trying to figure out how to do the response during the
time of the emergency.

[Matt Oldham:] Tim, is there any insight about what makes this current
outbreak such a difficult thing to test?

[Tim Persons:] That's a great question because we want the diagnostics,
that's a key issue right now that we're seeing. Having not only enough
tests but making sure that the tests we have we have are as accurate as
they can be. One of the challenges in the activity of diagnostic medical
testing is, making sure we avoid what are called false positives. Which
means the test says that you have something when you really don't. And
sometimes even worse in this kind of scenario is what's called the false
negative. Meaning it says you don't have it when you actually do. What
makes this one so -- challenging at moment is because it's so new we
haven't seen it before; you've got to do the entire development cycle of
a diagnostic. And you want, again, to minimize false positives and
minimize false negatives. And because you have to treat patients that
come in, as is happening now, patients are going into clinics and
they're think -- they're saying, "Look, I have flu-like symptoms, but do
I have coronavirus?" Right? And you want the system to be able to
reliably, and in a very timely manner, not days later, you'd like to
know right away ideally, and you want it with high accuracy. I do think
that, though it's difficult, I think like we just recently wrapped-up
some work on artificial intelligence for drug development, and really, a
vaccine is just a variant of a drug to develop. And so, we're really
talking about using advanced machine learning systems and AI to try and
essentially de-risk the research, and try and find those things that
maybe we can find them faster, and then put it into that development
pipeline, work on the agility of that development pipeline, open up and
share more among, especially the Federal Biomedical Research Community
that sometimes it shares with itself, but not necessarily with a lot of
our very good academics, and maybe some nonprofit research institutions
or even partnerships with for-profit institutions. And leverage the
massive and powerful innovation -- system and institution that we have
here in the United States.

[Matt Oldham:] Were there any other issues that you have found in prior
work that we can, that we know are out there that we can expect the
government's going to have to contend with other than testing?

[Chris Currie:] For over a decade, really starting after H1N1 in 2009 we
started raising serious concerns about the US's ability to handle
something like this for a number of reasons. First of all, it doesn't
happen very often. It's hard to predict, it's a, what we call like a no
notice event, you know, it's not like a hurricane where you get a week's
notice that something's coming. The other thing is, it's spread out so
much across the federal government and the state local government and
the private sector. And while there are some clear authorities, and Mary
talked about it, like under a Public Health Emergency, biodefense, I
think there's over two dozen presidentially-appointed individuals at the
federal level with some sort of responsibility for biodefense. So, we've
been concerned about our ability as a government to coordinate
day-to-day activities, and a response like this. So, we actually just
issued a report two weeks ago on the National Biodefense Strategy. It's
the best effort we've seen so far of the decade to try to coordinate
that. That should help, it's not a response strategy for something like
what's happening with COVID-19, but it's the day-to-day foundation that
you need to better prepare for something like this.

[Matt Oldham:] So, it sounds like the government has a day-to-day
strategy to better prepare for an outbreak like this. When we come back
from the break, we're going to talk about some elements of that strategy
that should give you confidence. Don't panic.

[Mary Denigan-Macauley:] CDC has put out basic information that just
washing your hands, if you're not feeling good, stay home. 

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[Mary Denigan-Macauley:] We can have confidence that everyone who's
involved, all of those dozen of agencies that look at biological events
are coordinating and working together to address the issue. Importantly,
CDC has put out basic information that just washing your hands, if
you're not feeling good, stay home. We recognize that that could be
challenging for some people whose salary is hour by hour and they may
want to go, but that social distancing, these are basic things that
people can do.

[Tim Persons:] And I think just having a reasonable stockpile, I don't
think you have to, you know, prep for any doomsday event here, but I
think you need to have several days' worth of various things. And I
think, shift the paradigm into; what can I do in terms of working from
home? Education from home, caretaking at home? Those are the -- or those
are the things that I think that you're seeing what we can do to protect
ourselves, again, avoiding panic.

[Matt Oldham:] You mentioned not panicking. What's the good news here?
What can we feel confident about?

[Mary Denigan-Macauley:] Remember, about 80%, to the best of the science
knowledge that's out there right now, about 80% of those infected either
have no, or mild, symptoms. So, you do also have to ask yourself, can
they shed the virus and therefore spread it, and be asymptomatic and not
show signs of being sick? So, there are still things we need to learn
about, but going into a panic mode and running and getting the toilet
paper, and you know, the numbers are going to go up as they get better
test kits, you're going to find more people that are tested. And that's
not always a bad thing, it means that we are actively surveying, which
is what the biodefense strategy, you know, that's part of it, is doing
that surveillance. 

[Chris Currie:] It's human nature to want to stop and try to find a
blame for something like this. The problem is, there're nobody or
nothing to blame for the situation. So, it's natural to want to look at
the response and poke holes in it, things like that. I agree with Mary,
I mean, the federal agencies are doing everything they can and executing
all their authorities to try to tackle this issue. And there's been a
number of things that have been over the years to try to improve that. I
know, for example, trying to speed up in an emergency case like this.
Getting rid of the regulations so you can speed up clinical trials to
get medicines on the shelf or get vaccines developed. I mean, remember,
this -- part of the reason this is called ‘novel' is because it's new,
you know, it hasn't been detected before. So, there's a reason we don't
have medicines and vaccines ready to go, it's not a failure in
preparedness, it's, you know, it's because it's a new naturally created
disease. So, the key is, we get rid of the red tape, so we can, you
know, respond to this as quickly as possible. And I ensure that, you
know, I'm sure that agencies are doing everything they can to try to do
that.

[Tim Persons:] Right. So, I think like, when you're talking about the
preparedness, well, like Chris was talking about, I think this always
gives us a new chance to say, well, how can we prepare better next time?
We can ask ourselves, how do we build more agility, more coordination in
the system? We need to rethink that in a 21st century context with
convergent technologies and AI Computing, Machine Learning, plus newer
ways in leveraging the biotech enterprise that we have, both public and
private sectors. So, I think the opportunity here is how we can use
lessons learned from this and apply it in a prospective way. I think we
should obviously, understand the tremendous value of the basic research
enterprise of the country, and how we might convert that research into
that development pathway toward solutions. So, that when we hit the next
novel coronavirus, we'll identify it quicker, we'll be able to build a
response quicker. We'll be able to handle, or perhaps think about in
terms of quarantine or get the data, quicker, and have an overall
risk-managed response.

[Matt Oldham:] I mean, that' brings up a good point, and Mary I'll ask
you, what sort of critical steps should we be keeping an eye on, the
government will be taking?

[Mary Denigan-Macauley:] This is an event that's happening now, and
while it's scary and it is a public health emergency declared by the
Secretary of Health and Human Services, there will other events. There
will be hurricanes, there will be another biological event down the
road, and it's important that we don't take funding from preparing for
those events for this one. And we did see that happen in Zika, and they
took money before the supplemental appropriations were put out, I think
it was 2016. HHS took money from the state and local preparedness to be
able to address Zika and that can be really detrimental.

[Matt Oldham:] Final question, what's the bottom line?

[Tim Persons:] What, again, makes it so hard is that there's a number of
folks that will get infected that don't know that they're infected, and
they'll carry it around. There's higher-risk populations, older adults
typically 60 and older, especially when you get up into 80 and older,
it's -- the undesirable outcomes go much higher on that. And, or if you
have what are called co-morbidities, meaning you have a, you're a
diabetic or you have COPD or other lung type diseases, or you've been a
smoker in the distant past. Those are the things that put you in this
place, but I think we're all in this together. I know we have a world
class Public Health System; the challenge is going to be having it
inundated with so many people going into hospitals that it can't treat
everybody. And then, again, that's why the diagnostics, and the science,
and the vaccine development is so important, we are all looking and
hoping very much for that rapid vaccine development, running through the
trials of de-risking, being able to manufacture it quickly, and starting
to implement to get us through this.

[Matt Oldham:] So, it sounds like the government has learned lessons
from past outbreaks, they have a plan. And you can help yourself and
others out by doing things like washing your hands frequently or staying
at home if you feel sick. Thank you to Mary Denigan-Macauley, Chris
Currie, and Tim Persons for taking the time to talk about their work in
this area. You can find GAO reports and Congressional testimony on
Pandemic Preparedness, the National Biodefense Strategy, and Coronavirus
at gao.gov. And thank you for listening to this Watchdog Report Deep Dig
Edition. To hear more podcasts, subscribe to us on Apple Podcasts. Make
sure you leave a rating and review to let others know about the work
we're doing. And for all things GAO, visit us at gao.gov.

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