Why COVID Crushed Us: Former FDA Commissioner Dr. Scott Gottlieb Details America’s Botched Pandemic Response

Scott Gottlieb

Female : Welcome to Conversations on Health Care with Mark Masselli and
Margaret Flinter. A show where we speak to the top thought leaders
in health innovation, health policy, care delivery and the great minds
who are shaping the health care of the future.

This week Ma rk and Margaret speak with former FDA Commissioner
Dr. Scott Gottlieb. He’s just released an in - depth analysis of the
nation’s failures in response to the pandemic, uncontrolled spread,
why COVID - 19 crushed us and how we can defeat the next pan demic.
He examines the inherent weaknesses and the CDC’s ability to
respond to a crisis of this magnitude, the need for more widely
deployed at - home testing, better surveillance diagnostics and the
promising discoveries in vaccines and therapeutics coming down the
pike.

Lori Robertson also checks in, Managing Editor of FactCheck.org looks
at misstatements spoken about health policy in the public domain ,
separating the fake from the facts. We end with a bright idea that’s
improving health and wellbeing in ev eryday lives. If you have
comments , please email us at [email protected] or find us on
Facebook, Twitter , or wherever you listen to podcast. You can ask
Alexa to play the program . Now, stay tuned for our interview w ith Dr.
Scott Gottlieb h ere on Conversations on Health Care.
rd
Mark Masselli : W e're speaking today with Dr. Scott Gottlieb, physician and 23 ,
Commissioner of the US Food and Drug Administration from 2017 to
2019. Dr. Gottlieb is a senior fellow at the Amer ican Enterprise
Institute. He also serves on the board of Pfizer, which produced the
first approved vaccine for COVID 19.

Margaret Flinter: Dr. Gottlieb is the author of Uncontrolled Spread : Why COVID - 19
Crushed U s and H ow We C an D efeat the N ext P andemic , which just
debut on the New York Times bestseller list. He's also a medical
contributor to CNBC. Dr. Gottlieb, welcome to Conversations on
Health Care.

Dr. Scott Gottlieb: Thanks for having me here today.

Mark Masselli: Dr. Gottlieb, your book, Uncontrolle d Spread , congratulations debut a
week ago. W e're marking the same time 700,000 American deaths
from COVID - 19. W e're still being crushed by this virus. But analysts
are predicting the pandemic phase will end next year shifting from the
pandemic to endemic . T here was some promising news this last week
on a New Oral Therapeutic produced by Merck that reduces illness
and hospitalizations by 50% i n infected people . You’re calling this a
new development , a game changer. Tell us more about the drug and
your thoug hts on why America might not be able to take full
advantage of the drug, because we're simply not buying enough
doses.

Scott Gottlieb

Dr. Scott Gottlieb: Yeah, look, this is a orally available drug from Merck, it's probably the
most profound treatment effect that I've se en from a pill in the
treatment of any respiratory pathogen , 50% reduction in the risk of
hospitalization and death. T his was a population of patients that it
was tested in who had risk factors for COVID. They had one or more
risk factors for COVI D, and th ey were also symptomatic at the time
that the drug was administered , s o they had to be within five days of
the onset of symptoms. T hey had advanced disease , they had already
progressed in the course of illness made to these patients , and so it
was a high r isk population, yet you still saw very profound treatment
effect.

T he problem is that we ’re just not going to have enough of it. Merck
said that they will be able to make 10 million doses between now and
the end of the year. But the US has procured so far only 1.7 million
doses, and they have an option on some additional doses, but not a
lot. We do know that some portion and maybe some good portion of
that 10 million has been pledged outside the US. T o give you a sort of
a basis of comparison, 1.7 million d oses might have been enough to
cover us for a month , D elta wave. If this drug was sort of approved for
the targeted population, it's approved more broadly than it wouldn’t
have even covered a month the D elta wave probably would have
covered three weeks of the D elta wave.

T o give you another basis of comparison, we've stockpiled
somewhere between 50 to 80 million doses of flu medicines in
preparation for a feared pandemic flu. W e procure d 1.7 million doses
of this Coronavirus drug in the setting of a raging Coronavirus
pandemic a nd we've stockpiled upwards of 80 million doses of a flu
drug for a flu pandemic that we fear but it hasn't arrived yet. T here's
sort of a mismatch between what we what we need in the setting of
this pandemic and what we ultimately pr ocured . T here's probably
things we could have done much earlier to ramp up manufacturing of
this drug to have more available now, but it's too late at this point .
There’s not much you're go ing to be able to do in the near term.

It just, it sort of undersco res the lack of preparation. This is another
point I'll get back to in the book , not having the reserve capacity to
scale the production of some of the therapeutics and
countermeasures that you're going to need in a setting of pandemic.
We just don't have available capacity in this country that's ready to go
t hat's being kept as sort of a hot base of preparedness.

Margaret Flinter: Well, Dr. Gottlieb in your book, Uncontrolled Spread , you note that
America was failed by not only some bad political decisions , but also
an ill prepared public health infrastructure that you described as the
fog of viral war. We know there were missteps along the pandemic
trajectory , a nd particularly you call out some CDC, which we've all

Scott Gottlieb

long considered the gold standard for pub lic health. But you point to
issues in the inherent culture at CDC that contributed to this and that
it just wasn't structurally designed for rapid response to a large scale
crisis. Share some of that analysis with us.

Dr. Scott Gottlieb: Look , the CDC is the gold standard for public health , t here's no
question about that. But there is a difference between the CDC ’ s sort
of normal function and being able to respond to a public health crisis
of this magnitude having a logistical capacity and the ability to g ather
and do real time analytical work to inform policy decisions that need
to be made in the moment. CDC is sort of a deeply analytical
organization, high science organization, accustomed to doing very
exquisite scientific analyses to try to be the defini tive word on a public
health question, not the first order on a public health question . In the
setting of a crisis like this, when you need to have a capacity to mount
a very large, coordinated logistical response, for example, being able
to develop and de ploy massive screening, massive testing that was
required early on in the pandemic, or you need the ability to gather
real time data and do very rapid analysis to inform decisions like what
are the modes of transmission? What are the geographic and social
compartments in society where the virus is spreading? How do we
take steps to reduce transmission? Should we stand three feet apart
o r six feet apart o r 10 feet apart? What's the right distancing? H ow
effective are masks going to be ? A nswering those critic al questions , w
really didn't have an organization capable of doing that, in sort of the
real time fashion that was required for this crisis.

CDC just didn't have the resources, the culture, the aptitude to do
that. It's not an argument for sort of buildin g a new organization ,
building a new agency . I think what we need to do going forward and
thinking about this is how do we build those capabilities into CDC . I
think there was a sort of a presumption that CDC had this ball and
they were able to discharge t his mission, it just was never going to be
the case , a nd policymakers were slow to realize that.

Margaret Flinter: Dr. Gottlieb, the subtitle for another book on this might be what we
would have done and when we would have done it if we'd only known
and re ally thought things through . Y ou talk a bit about in your book,
the CDC first attempted a COVID test failing and having to go back to
square one with what that cost in terms of time and lives.

W e recently had Harvard's Dr. Michael Mina on the show , a nd he
says, if we'd simply focused on providing all Americans with simple at -
home rapid tests, we could have gotten out in front of the pandemic
much earlier , a nd instead we focused on the more complex PCR tests.
Is that y our conclusion as well that --- and we s ay this is a organization
that put enormous effort into doing mass testing clinics with PCR,
should we really have been focused on the rapid test right from the

Scott Gottlieb

start , would that have made an appreciable difference?

Dr. Scott Gottlieb: Yeah, we needed an a ll the above approach right from the outset. I
talked a lot about the testing failures in the book and get into a lot of
detail of why we didn't have tests that we could deploy more widely.
But at some point in January, someone needed to recognize that thi s
could become a global pandemic a nd we needed to get testing
ramped up . N ot just the diagnostic test kits that can run on a complex
PCR machines that are inside labs, but also the point of care tests,
because there's a long lead time to actually developin g those tests.
We didn't get started on that till much later , a nd that's why we don't -
- we didn't have those rapid point of care tests and at - home tests like
the by next [ inaudible 00:08:32 ] test until much later in the course of
this pandemic.

Yeah , we d idn't have a good strategy about how to scale and deploy
testing in this country in the setting of a pandemic. If you go back and
look at the pandemic plans that have been done, most of them had
been focused on flu and the pandemic preparedness , that table top
exercises that we did, and I was part of some of those when I was in
the federal government . We never really envisioned diagnostic testing
being an essential part of pandemic response b ecause if y ou're
dealing with a flu, first of all, the incubation p eriod for flu is short,
three days . S econd of all, you're not contagious until you're
symptomatic. T esting isn't as essential a component to try and to
identify asymptomatic spread and asymptomatic carriers because
number one, asymptomatic people aren't go ing to go on to spread
the virus in an appreciable amount. T wo, by the time you become
contagious, it's a short incubation period, so you haven't been in
contact with as many people so doing the testing and tracing isn't as
essential of a component of actu ally preventing the pandemic, the
progression of the pandemic .

Th ree, the installed base of flu tests that are available in every
doctor's office would be sufficient , because if you had a pandemic
with an influenza A or an influenza B, doctors in their off ices have
tests that could differentiate influenza A from influenza B and if that's
the prevailing strain -- pandemic strain is influenza B and you can
diagnose them with influenza B, you know they have a pandemic
strain . W e never really planned for being able to develop and mass
deploy novel diagnostic tests in the setting of a pandemic, because we
always plan for flu . In flue , we -- the testing wouldn't be as essential
a nd we'd have an installed base of testing that we could use.

T hat was part of the rea l challenge early on is no one thought about
this, no one thought of getting the diagnostic test kit makers in the
game early enough, and we we've never had enough testing. E ven
now, we still don't have enough of these at - home test that could be

Scott Gottlieb

highly eff ective at controlling the spread of the virus . T he ones that
are available are expensive and many people are priced out of it. We
haven't adequately subsidized it for people who are priced out of this
market.

Mark Masselli: We're speaking today with Dr. Sc ott Gottlieb, former FDA
C ommissioner and author of Uncontrolled Spread : W hy COVID - 19
Crushed Us and H ow We Can Defeat the N ext P andemic. Dr. Gottlieb
you say so eloquently in the book, the pandemic has shown that we
need to reimagine the role at CDC . Y ou suggest that we amp up the
intelligence capacity of the agency more in line with what the NSA
does. But that will require an act of Congress , President Biden's
infrastructure bill allocated additional resources to improve the
capacity of the CDC. But the q uestion is, have they allocated enough?
And ho w should that money be deployed i f approved to make the
CDC more responsive in a future crisis?

Dr. Scott Gottlieb: T he argument in the book is that we can't rely just on public health
conventions to alert us t o outbreaks in would be hotspots. We've long
relied on the international health regulations, which is a binding set of
commitments that countries make in the context of the work they do
under the World Health Assembly as part of the World Health
Organizati on. C ountries sort of voluntarily agreed to surface
information if the y’re host to an outbreak of a novel disease. That
hasn't worked.

I mean, we've seen time and time again, countries haven't fulfilled
their obligations u nder the IH --- the International Health Regulations,
including the Chinese government haven't fulfilled their obligations,
not just in the setting of SARS - cov - 2 but also in the setting of SARS - 1.
We strengthen the IHR after SARS - 1 on the hopes that if we
strengthened it, it would be more binding. T he Chinese government
still flouted the commitments that they made under those
regulations . T hey still haven't shared the source strains of the virus.

M y argument is we can't rely on just public health institutions and
public health conventions a lone, we're going to have to get our
intelligence services more engaged in monitoring these threats . It’s
actually been legislation introduced to do just that, by r epresentative
shift s o it looks like we're moving in this direction of getting our
national security tools more engaged in a global public health mission.
As far as resources, there's a lot of resources right now being
allocated and there's more being contemplated . The Biden
ad ministration put out a sort of template for what they think a future
p andemic preparedness proposals should look like a nd it includes an
enormous amount of money in it. I think the money is going to be
there. The question is, how to program it, and also how to give very
specific guidance to CDC in terms of how CDC needs to r eform itself.

Scott Gottlieb

In the past, Congress has written legislation directing CDC to do
certain things, and the agency has simply ignored the legislation. I
mean, the most -- the one that's most apparent th at I talk about in a
book is Congress sort of obligated CD C to build out a new
infrastructure for data collection in the country , a nd CDC never
implemented it. The GAO did a report and came to the same
conclusion that the CDC the agency just failed to act on Congress's
mandate. Congress is going to need to come - - it’s go ing to have to
come in, and very specifically reprogram that organization to create
these capacities. They did it with FDA.

W hen I was at FDA, you know, Congress was very specific and
granular in directing the FDA to reform itself in certain ways . I think,
ultimately had a very positive impact on the agency driving change in
the agency. I think they ’re going to have to do with CDC t he
challenges. There's not that many people in Congress who really
understand the CDC w ell . I mean, there was a lot of -- there was a
group of Congress, people, senators, Congress, people who
understood FDA well enough to write very specific legislation.

CDC has been a little bit more of a black box , a nd that's why Congress
is sort of allocated money to CDC but left a lot of discretion to the
agency, how it implemented reforms . I don't think we can afford that
luxury anymore. I think we have to have sort of a -- put together a
commission or some group that's going to write very specific
legislation, prescribing a very spec ific set of reforms to get the agency
to have the capacity to deal with a crisis like this in the future.

Margaret Flinter: Well, Dr. Gottlieb thank you for that , a nd your early comments in your
response about what we did and didn't know coming out of Chin a
back in the late fall, early winter at the beginning of the pandemic is
certainly a case of if only we'd known . But here we are with
vaccination is our best strategy to stop this relentless progression of
infection and death. W e have made progress but we still see
resistance in different places around the country in the South and the
Midwest , and then recently j ust really tragic news coming out of
Alaska .

Y ou've looked at the issue of federal vaccination mandates which the
President is attempting in certa in sectors and said, probably not the
answer, probably further politicizes vaccine uptake. But it does seem
like we're seeing some movement, maybe some positive impact from
the mandates. Is that still your though t or ar e you swayed by some of
the recent ne ws showing some progress where there are mandates?

Dr. Scott Gottlieb: Well, I think certain mandates make a lot of sense , a nd I've been very
clear on this. I think mandating vaccination among health care
workers makes a lot of sense. I think the federal g overnment certainly
within its -- the scope of its authority to mandate vaccination among

Scott Gottlieb

the federal workforce, it's a matter of readiness of the federal
workforce, the D epartment of D efense . I think we should be
prescribing greater mandates in the Medica re program using the star
rating system, we could be requiring Medicare plans to have to
vaccinate certain high percentage of their populations for COVID as
well . W e haven't done that yet. I think we should, because that's a
very vulnerable population. B ut I think that the issue of mandating
vaccination among private businesses and small businesses versus
trying to use incentives to drive that, I think we need to look at that
carefully.

What I haven't seen is the policymakers in the federal government
step forward and say, t his is what we need to achieve in terms of
vaccination rates. T hese are the different policies that are going to get
us there , a nd this is how much incremental vaccination we think we're
going to achieve with these different policies s o w e can actually do a
careful way from a policy standpoint of what we need to achieve, and
what are the best ways to get there. Right now, it seems very open
ended, it seems to be the policy is more, get more people vaccinated .
W e don't really know what the upper bound that is achievable, let
alone sufficient from a public health standpoint in terms of providing
a proper wall of immunity. Let's do everything a n d anything we can
and not really understand which policies are going to achieve more
vaccination ver sus which policies are going to be more divisive, create
more acrimony, create more division around vaccination, not
necessarily achieve a lot of vaccinations , s o it doesn't feel very
deliberate. To me, it doesn't feel like we have a very clear sense of
wh ere we want to get and what are the tools for getting there. T hat's,
where I think we need to be much more careful in terms of
policymaking, we ought to understand what the goal is, we ought to
understand what the different measures are that could get us t here
a nd what the tradeoffs from those different approaches a re . T here's
been no discussion of that.

A t the end of the day, what is the limiting principle here? I mean,
there's obviously an end to what you can do to try to drive more
vaccination. But if yo u don't prescribe sort of a goal and a different set
of measures and how you think that those different measures are
going to achieve the outcome , i t doesn't -- there's not a clear limiting
principle to what you are able to or willing to do . W e should -- p olicy
should be much more deliberate than it feels right now.

Mark Masselli: Yeah, a nd I think you say that data should drive some of that policy,
we've got to line up that data to make sure that the policymakers are
aligned with it. You talked earlier abo ut the FDA thinking that it really
didn't need a review , p erhaps the CDC does. But I know there's been a
lot of criticism of both the FDA and CDC around pediatric, the 5 to 11
year olds and sort of the time it's taken for us to get the vaccine

Scott Gottlieb

developed fo r young people. What's your sense about upcoming
review that Pfizer has put their information in front of the FDA, the
CDC, around young people, but the American Academy of Pediatrics
has come out and criticize d the length of delay here. What do you
make o f all of that a n d w hat's your sense about the timing for the 5 to
11 a nd then certainly the younger ones after that?

Dr. Scott Gottlieb: L ook, I don't think this has been significantly delayed. It 's maybe a
month past where we thought we might have been th ree or four
months ago, because the agency, the FDA asked for some additional
data , ask for the trials in the kids ages 5 to 11 to be a little bit longer, a
little bit larger. But , so we're not talking about a significant amount of
time. Now, obviously, in the setting of a pandemic, any amount of
time is significant. But I think if the tradeoff of that is that you're going
to have a bigger data set , a better data set on which to base a
decision , try to give the public better information .

T he public health c an be benefited in the end, because you're going to
be able to allow people have more confidence about using the
vaccine and maybe get more uptake. T his is where you have to
engage in a careful balancing a nd you have to be very sort of
prescriptive about w hat you're doing and why and what you think
that the tradeoffs are. I think the FDA has been careful in doing that
balancing. I think the FDA is oftentimes more deliberate and
transparent about what it's doing , what it thinks the tradeoff s
[ inaudible 00:19 :52 ] p ublic health benefits are and it's kind of getting
back to the last discussion about what are we trying to achieve in
terms of vaccination rates and what are the policies to get us there? I
think we'v e been fairly deliberate about it h ere .

A gency is going to be meeting on October 26 to discuss the Pfizer
vaccine and company I'm on the border of and kids ages 5 to 11.
Assuming that meeting has a positive outcome, the agency authorizes
the vaccine based on the datasets that's available . CDC would be
pre pared to meet very soon after that, almost immediately after that
as I've been doing and make a recommendation. T his vaccine, I think
is on course to be available by Halloween or thereabouts if everything
goes well. U ltimately, these two agencies feel that the Pfizer data
package supports it s safe use.

Mark Masselli: Tell me what your sense is on the horizon, y ou're very positive about
the Merck drug. But what else do you see the public should be
keeping its eyes on in terms of the development that's going on with
antivirals or other improvements in the science that have happened
because of the mRNA platform? W hat do you see out there that
animates your thinking?

Dr. Scott Gottlieb: Yeah, look, we have a much better toolbox now than we did when we
started. C ertainly, I mean, we have a safe and effective vaccines,

Scott Gottlieb

multiple vaccines, we have point of care test that can be used at
home, FDA has undergone sort of a dramatic cultural shift in terms of
making tests available in the home for the diagnosis of not jus t an
infectious disease b ut a reportable pathogen . M a ybe three years ago,
two years ago, that would have been unheard of the agency allowing
those kinds of authorization. Now the agency has undergone really a
shift in its thinking around this.

We have oral ly available, the Merck drug, an orally available drug that
looks very promising. There's two more in advanced development,
one by Pfizer, come on the board of one by Roche, all three of those
drugs could potentially be available by the end of this year, s hortly
thereafter. W e have a much different toolbox. I mean, if we go into
the future with effective vaccines, higher vaccination rates, we ’re
chipping away at getting people vaccinated . We’re at 70, almost 78%
of adults over the age of 18 have now had at least one dose , most will
complete the series. W e're building that wall of immunity through
vaccination.

Also, frankly, through infection, I mean, people are getting infected,
and they do have a durable immunity, especially if D elta infection
we're going t o have orally available drugs that could treat people who
have breakthrough infections or small number of people who
unfortunately choose not to get vaccinated, we'll have drugs
available, monoclonal antibody drugs are highly effective. Those are
being for mulated in subcutaneous delivery s o you can you can deliver
it in doctor's office just for the simple injection. I n the advent of these
p oint of care and home diagnostic test, it's going to make testing
much more accessible.

E ventually supply will catch up to demand , it's getting there , a nd
hopefully the costs come down. This is a much better toolbox. T his
will allow us to turn this into a more manageable pathogen a s we sort
of transitioned from the pandemic phase of this virus to a more
endemic phase with this just becomes a persistent menace that we're
going to have to learn how to grapple with.

Margaret Flinter: Well, that is a positive note to end on. W e've been speaking today
with Dr. Scott Gottlieb, former FDA C ommissioner and the author of
Uncontrolle d Spread : W hy COVID - 19 Crushed U s and H ow We C an
D efeat the Next Pandemic . Learn more about his latest work and
access his book by going to uncontrolled spread.com . Follow his policy
work at the American Enterprise Institute, or follow him on Twitter
@ Scot tGottliebMD.

Dr. Gottlieb, we want to thank you for your analysis on our pandemic
response for illuminating ways that we can strengthen the nation's
public health infrastructure to better meet the next challenge, and for
joining us today on C onversations o n H ealth C are.

Scott Gottlieb

Dr. Scott Gottlieb: Thanks a lot, thanks for having me.

Mark Masselli: Thanks so much.

Margaret Flinter: Thank you.

[Music]

Mark Masselli: At C onversations in H ealth C are, we want our audience to be truly in
the know when it comes to the fac ts about health care reform and
policy . Lori Robertson is an award winning journalist and Managing
Editor of F act C heck.org, a nonpartisan, nonprofit consumer advocate
for voters that aim to reduce the level of deception in US politics. L ori ,
what have you got for us this week ?

Lori Robertson: Studies on whether Ivermectin is beneficial in treating COVID 19
patients haven't been conclusive, and health officials have warned
people not to self - medicate . B ut multiple large trials are continuing to
assess the an tiparasitic drug. The Food and Drug Administration has
not approved the use of Ivermectin to treat or prevent COVID - 19. The
drug is approved for human use only to treat some conditions caused
by parasites, including head lice .

A lthough the National Institu tes of Health counts over 70 studies
evaluating the safety and effectiveness of Ivermectin to treat or
prevent COVID - 19 In humans, the FDA says the currently available
data don't show it's effective against the disease, and that using it for
this purpose i n humans or animals can be dangerous. In fact, the FDA
said the agency has received multiple reports of people needing
medical attention after ingesting Ivermectin intended for livestock,
which comes in doses that can be toxic for humans.

Animal Ivermectin , which is different from the one intended for
people helps prevent heartworm disease and other parasites in
different animal species. One expert told us if people are interested in
Ivermectin , and whether there is a benefit for COVID - 19 treatment,
they sh ould participate in a clinical trial. Preliminary results from one
trial in Brazil found no indication of a benefit in using Ivermectin
among high risk non - hospitalized patients, but two large clinical trials
are still being conducted in the United States.

One , a randomized controlled trial led by the University of Minnesota
Medical School is recruiting volunteers . Researchers expect to have
preliminary results by December. A second large study, funded by the
National Institutes of Health and led by the Duk e Clinical Research
Institute is also enrolling participants. Both studies involve non -
hospitalized patients, and the y were also evaluating other
medications. Researchers in the United Kingdom are also studying
Ivermectin in a large trial that is analyzing possible COVID - 19
treatments. The results of these trials will provide more definitive

Scott Gottlieb

data on the drug. T hat's my fat check for this week. I'm L ori
Robertson, Managing Editor of F act C heck.org .

Margaret Flinter: FactCheck.org is committed to factual accur acy from the country’s
major political players and is a project of the Annenberg Public Policy
Center at the University of Pennsylvania. If you have a fact that you’d
like checked, email us at chcradio.com, we’ll have FactCheck.org’s Lori
Robertson check i t out for you here on Conversations on Health Care.

Mark Masselli: Each week, C onversations highlights a bright idea about how to make
wellness a part of our communities and everyday lives. One in five
Americans will suffer a diagnosable mental health cond ition in a given
year, and most often don't seek treatment. For those with serious
mental health conditions t he consequences can be devastating ,
hospitalizations, loss of job or home or even early death. S eeing a rise
in mobile apps aimed at behavioral hea lth entering the marketplace,
University of Washington R esearcher Dror Ben - Zeev drawer thought a
comparative effective analysis study would be a good idea.

Dror Ben - Zeev: My team and I conducted a three year comparative effectiveness trial
with the objecti ve of having a head to head comparison between a
mobile health intervention for people with serious mental illness
called F ocus, and more traditional clinic based group intervention
called WRAP or Wellness Recovery Action Planning. I t's conducted at
a clin ic setting , people with similar diagnoses.

T he study really gets at some of the core differences between mobile
health and clinic based care. Is there something about the mobile
health approach that would make it more accessible or less
accessible? Would p eople find it less engaging over time ?

Mark Masselli: more than 90% of the mobile app group engaged in the online
program, which was a series of text messages, offering coping
strategies and self - monitoring of symptoms along with weekly call - ins
with a beh avioral health clinician .

Dror Ben - Zeev: T he second thing we want to see is after people complete care, what
are their subjective ratings of their experience and treatment? Are
they satisfied with both interventions? Are there differences in their
levels o f satisfaction ? P robably the most important piece of the study
are the clinical outcomes. W e measure to see whether involvement in
both interventions for a 12 week period , would that create some sort
of difference in psychiatric symptom, severity and quali ty of life.

90% of the individuals who were randomized into the mobile health
arm actually went on to meet a mobile health specialist to describe
the app to them and train them how to use it , and use the
intervention app that's assigned to them at least on ce. Whereas in the
clinic based arm, we saw that only 58% of the participants assigned to

Scott Gottlieb

that clinic based intervention ever made it in for a single session .

Mark Masselli: B oth groups of patients saw roughly equal results from their
completed treatment, but the mobile group was more likely to
engage in therapy. Ben - Zeev says this suggests that mobile therapies
may provide a useful tool for clinicians having trouble getting those
with serious mental health issues to engage with the clinical
interventions.

Dror Ben - Zeev: T he group dynamics, the fact that there's a sense of shared
experience, and perhaps even normalization of some of the
experience , that on its own is quite potent for people, right? W e know
that the very existence of a group can be quite help ful. But for others,
the interaction is anxiety provoking, just making it to the clinic to
engage in that interaction is logistically complex. When it comes to
the clinical outcomes , i n both intervention arms , people improved
both in terms of reduction in their s ymptoms of the distress
associated with symptoms and improvements in their recovery.

Mark Masselli: The results of this study were published in the Journal of psychiatric
services, a targeted mobile app aimed at facilitating access to clinical
care for those experiencing serious mental illness symptoms, proving
equally effective and managing the condition , improving access to
intervention for behavioral health needs. Now that's a bright idea.

[Music]

Mark Masselli: You've been listening to Conversati ons on Health Care. I'm Mark
Masselli.

Margaret Flinter: And I'm Margaret Flinter.

Mark Masselli: Peace and Health

[Music]

Female : Conversations on Health Care is recorded at WESU at Wesleyan
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