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Language: en
the following is a conversation with
michael minna his second time on the
podcast he's a professor at harvard
doing research on infectious disease and
immunology
in my view the most powerful doable and
obvious solution to covet 19 from the
very beginning is rapid at-home testing
this is what michael has been talking
about and writing about since the
beginning of the pandemic
the accuracy of these tests is high for
the task of detecting contagiousness
which is what matters
hundreds of millions can be manufactured
quickly and relatively cheaply privacy
and individual freedoms are preserved i
believe that if you give people the
power of information
information about whether they are
contagious or not they will do the right
thing
at scale all while respecting their
freedom and minimizing the destructive
effects of the pandemic on our health
and our economy
the solution was obvious in may of 2020
it was obvious when michael and i spoke
the first time a year ago and it is
obvious today we talk about why it has
not yet been done and how we can still
do it this is the lex friedman podcast
to support it please check out our
sponsors in the description
and now here's my conversation with
michael minna
we spoke a year ago about rapid at-home
testing and i think you think
it should have been still should be a
big part of the solution to covid
so let's recap where do things stand
today in terms of rapid at home testing
well
it's a it's certainly something that uh
you're right i do think we should have
them today
we've now had almost
20 months of
living in anxiety uncertainty
uh being afraid for our health for our
family's health for our friends you know
shutdowns
economic instability everything has been
uncertain because this virus
and then there's this little test and
it's the first time for many people that
they are they're using it and they're
feeling
empowered they're feeling like they can
control their little slice
of this pandemic so
as these tests have come out and more
and more more americans have had an
opportunity to go and buy them from you
know cvs or walgreens or wherever
they're at
i think that it's really shifting the
tenor of the discussion
for a long time all of 2020 it was like
i often felt like it was me and a few
other people against the world you know
these tests should be public health
tools these tests are infectiousness
indicators they shouldn't be compared to
pcr
you know all of the these different
things and we could of course go through
and recap what those what the benefits
and the
metrics are that we should be looking at
but the point is
last year and most of this year
was about educating scientists educating
public health leaders educating
physicians
to get them to understand
that there is a different reason to test
in a pandemic than purely diagnostics
and transmission blockade and severing
transmission chains the big one so now
i think we're at a point where people
are now understanding and they're
understanding because they are feeling
it they're holding it and they're doing
it they're seeing they're feeling the
delight of seeing a negative
and saying i feel more comfortable it's
not perfect but it's pretty darn close
to perfect
to allowing me to go and see my mom
without mistakenly infecting her
you know or whatever the story might be
and now that that's happening i think
all of a sudden we're seeing a massive
change
politically for these tests
uh biden just came out the kova 19
action plan the other day and one of the
main pillars of it was testing and in
particular bringing rapid tests uh
scaling them up
so
on that front i think
finally there is success people are
actually understanding and
you know i haven't stopped beating this
drum
for far too long and i like hate rapid
tests now
so maybe it's good to step back uh
would you say most americans have not
taken a rapid home test absolutely most
have definitely not taken a rapid test
so like
many of them probably don't know they
kind of
probably say testing
they have like memories of testing like
pcr testing they have to go into
somewhere and they have to
like a
swab deep in their nose and that's the
experience so maybe when if you have to
travel like canada or something like
that you have to get tested that kind of
stuff so what are rapid at home tests
yeah so so the rapid at-home tests are
i like to call them paper strip tests
simple they're simple tests that i wish
i brought some today but i didn't um
they're simple tests that
uh
you
swab at the moment most of them use a
swab that you just swab the front of
your nose so it's not one of the deep
the deep swabs that you know goes into
your brain
and uh and so it's not very
uncomfortable it's just like picking
your nose if you'll you know and and you
you put that swab and
you put that swab into
a little tube
and the tube has some liquid in it and
then you
pour put a few drops of that liquid onto
a paper strip or you drop the paper
strip into the tube just like
one of those
indicators for the pool and if you dress
like a pregnancy test then if you get
two lines you're positive one line
you're negative
it's super simple it takes 30 seconds
once you know how to do it of hands-on
time and you wait around 10 minutes and
then you read the result
they are extraordinarily effective to
answer
one question am i infectious
and that is the public health question
that we need to answer and consistently
ask
during this pandemic are you infectious
am i infectious because it's only when
we know that we're infectious that we
can be empowered to not mistakenly
infect others
the pcr test is a little different
and we can go into
the pros and cons but
uh you know one of the the major
differences is that a pcr test
gets a lot of
a lot of people talking about the pcr
test say it's much more sensitive
and
at an analytical level it is it can
detect one molecule instead of a hundred
thousand
but for public health we don't want a
test that can detect one molecule in
fact that has created a net negative for
public health
we just want to know am i infectious and
to know that question to know if i'm
infectious i only need a test
that is going to be positive
if i have a high viral load like a
million
and when you're and the virus grows so
fast it will grow from zero to a billion
in a day
so you don't really need even on the
front end of an infection you don't need
better sensitivity
if the trade-off is that you don't get
the result for one two or three days you
absolutely want a rapid result
that can tell you yes you're infectious
you're transmitting to others right now
and i'm going to give you the results
right now so it is a much more effective
tool because it's fast because it's
accessible we can use them in the home
and there's some issues with using them
a home we can talk a little bit about
what those issues are like reporting and
how do you is everything on the honor
system if you have a test that you're
taking at home and you use it to go to
work
but they can be they can be accessible
pcr has to go into a lab it takes a lot
of time for somebody to get a pcr test
they either have to go online and order
it it takes the next day for it to come
back
they swab themselves they ship it out
the next day and then they get a result
two days later
that's four days minimum for the most
part and you know at that point you're
not even infectious even if you did
happen to be infectious when you first
ordered the test right
so it's really of the speed of these
tests and the accessibility and
distribution of them that makes them so
immensely powerful so this like amazing
graphic you tweeted
it's
exactly what you're saying which is a
rapid antigen test
answers the question am i currently
infectious and you have i think a
comparison of three different uh sorry
seven different tests based on the viral
load
and based on the viral load across these
different tests
you look at the likelihood of
infectiousness
so what is this graphic show we can
overlay that for people just i think
it's just really nice and really clear
yeah so what that's showing is that we
can never ask what's the sensitivity of
a test and just let that be the answer
that's what the fda does currently
and that question doesn't mean anything
we have to say what is the sensitivity
of the test to detect what right
and so we can have different viral loads
for example we can have
you can have a viral load of one or you
can have a viral load of a trillion and
a pcr test will tell tell you that you
are positive regardless of whether it's
one or a trillion
now so we can't ask the question how
sensitive is a rapid test compared to
pcr because that covers the whole gamut
what we really want to say is how
sensitive is the rapid test
to detect me if i am infectious
and that gets to about 97
or so
sensitive
if the question is how likely is it to
detect me if i'm a super spreader that's
a really important one to be able to
detect they're all about 100 sensitive
so if you have extraordinarily high
viral loads to the point where you might
be a super spreader these simple rapid
tests will essentially always catch you
and tell you you're positive
and then as you go down the line if
you're no longer infectious at all
then these rapid tests might have a zero
percent sensitivity compared to pcr but
that's actually a good thing the fda and
others look at it as though it's a bad
thing because they average it all
together and say oh
this is only a 40 sensitive test
compared to pcr
but that's not the right way to look at
it you want to say well out of all of
the samples how many of them were not
transmissible how many were mid moderate
high extremely high super spreader
and you should at the very least create
a weighted average based on
transmissibility potential
we don't do that you know and that's why
nobody in america has these tests
because that's why they're very rare
because we have slowed down their
authorization because of that
misunderstanding that they don't have to
be
80 or 90 sensitive compared to any time
pcr positivity
they need to be 80 or 90 or more if
you're infectious and for that question
they're like 95
up to 100 sensitive when you're most
infectious so you have a lot of iron
particles in you so i mean that's what
it means when you say viral load that
means you're going to be very infectious
the more you have the more infectious
you are and this test is
basically
very good at detecting when you're very
infectious
why don't we have
a rapid home test so you said there's a
bit of confusion
fda is involved you've talked about you
continue to talk about
that
these at-home tests are classified as i
guess medical devices that's right and
so because of that fda is looking at
them differently
then they probably should be looked at
so
what what's the problem here
can you can you sort of explain what
does it mean to be a medical device why
is that an issue where is the fda
messing up
when we declare something as a medical
device and we evaluate it as a medical
device then it makes sense that the
comparison if you're trying to get a new
one onto the market
that the comparison would be against a
gold standard medical device for that
purpose
so pcr
is currently the gold standard or at
least
in
the in the eyes of the fda the pcr test
is the gold standard
uh medical device
and as a physician that's because it's
so sensitive
as a physician
i have one patient in front of me at a
time
and that patient comes to me and i don't
have to care about the 99.9999
of people
in the world who are not
in front of me i only care about that
one patient
and so when i get a sample from that
patient and that patient's saying doc
you know i don't feel well i haven't
been feeling well for the last few weeks
do you think this is covid
well for that question i want to have
the absolute best sensitivity test
regardless of what it means for
transmissibility because my patient
isn't sitting in my office saying doc do
you think i'm infectious
they're saying doc do you think i have
recently been or am infected
and these are totally different things
one
is medicine
and if the patient's infected you know i
the time isn't of the essence because
they're sitting there in my office i can
say look
i'm sorry you're not feeling well let's
get a pcr test on you we'll be able to
tell you if you have any
evidence that there has been recently an
infection inside of you
and you'll get the result in a couple
days
and it might be expensive and so
insurance is going to pay for it and
you're just one person and so i don't
really care how many resources it takes
to get you this answer
on the other hand
there's rapid there's public health
testing and public health testing is
it has to account for all of the people
you're not seeing as well as the person
you're testing at the moment so
accessibility becomes a central theme
frequency of tests it has to account for
all the days that you're not sitting
there in front of your doctor's office
getting a test as well as the one you
are so it has to say how frequently what
if you're infected tomorrow but you're
at the doctor's office today getting a
negative covet test
that pcr test at the doctor's office
today is going to do nothing
to let you know that you get exposed and
infected tomorrow the only way to know
that is to be testing yourself
frequently
so
and the the reason it matters is
that these tests can be accessible if we
are okay with saying the real purpose of
a of a
public health test is to answer the
question am i infectious
the reason we want to answer that is if
you're infectious that's when you
isolate
we actually don't want to isolate
positive pcr pcr-positive individuals
who are no longer infectious
that's bad public health practice like
if i haven't been infectious for three
weeks i don't want to have somebody tell
me that i need to
go and isolate for 10 days just because
i happen to use a pcr test
today three weeks after i was infectious
and furthermore i definitely don't want
the public health agency to come and you
know round up all the people i was with
last night and so you guys have to
quarantine
for 14 days because you were with
michael who wasn't infectious yesterday
it's nonsensical to do that
it's a huge disincentive to actually get
tested that's exactly right huge
disincentive to get tested people you
know if it's too sensitive especially
with flights things like that like
we shouldn't be stopping people from
taking a flight if they haven't been
infectious for 60 days and to be clear
people are only infectious for i don't
know somewhere between three and seven
days
but can be positive on a pcr test for
30 to 70 days
so i mean it's it's potentially a
tenfold difference in terms of how long
your pc are positive
versus how long you're infectious
so we don't want to be taking people
during those 30 to 70 days and saying
you need to isolate just because you go
and get a swab or you can't go on your
trip just because you had covered last
month
that's not good use of a test
so the reason we don't have these tools
right now is because
when we evaluate an ant a rapid test as
a medical device
the fda says
well this has to achieve the properties
that we expect from a medical device
which again
doesn't have to take time into account
doesn't really have to take cost or
resources or scalability or access into
account it only takes sensitivity and
specificity to catch molecules
and so just
by definition i mean it is a
mathematical fact you know that that if
you have a perfect public health test
for covid which means that it would be
100 sensitive
and 100 specific
for contagious people or for the
infectious stage of an infection
then it literally can't it is an
impossibility for that test to achieve
an 80 sensitivity at a population level
against a medical device which is what
the fda asks for and that's because
you're only infectious for maybe 20
so
theoretically it should only have a 20
sensitivity
against the pcr while still being a
perfect medical a perfect public health
test and the test is answering the
question am i infectious that's what
you're testing for not for the exact
counting of the viron particles in your
system that's that's exactly right okay
so what
why
are we still here
so have you had conversations with folks
you said that there's a bunch of um
leaders that are kind of starting to
wake up to this idea but why is this
taking this so long
why don't we still have hundreds of
millions of at home tests
the reason it's taking long i think is
because every agency and government
is generally deferential to the fda and
in this context
i would argue that government hasn't
been particularly creative
so for example last year trump was still
president i would or or in the
transition
and i i recall talking to the white
house a number of times and saying
here's a plan to give us our lives back
i think that was actually the title of
the atlantic article you know and
this plan can stop shutdowns it can it
can stop outbreaks it can allow society
to keep running and could have
prevented the outbreaks of last winter
and
fall and saved hundreds of thousands of
lives
so when i bring that to the white house
or to the government of federal
government whoever it might be and i say
here's a plan like this this would work
they say you know what i get back is
this sounds really interesting michael
uh it looks like it checks out but
there's one problem we don't have the
test there's no scale
and that's kind of where it all dropped
it's like this defeatist attitude of
like oh don't have the test so
so we can't act on it but now it's
really changing
well and so that's really where things
have been and so nobody's paid attention
it's always been this like esoteric
thing
that yeah maybe one day we'll get around
to it but really it's not that important
and the pandemic's going away but
this was like 100 predictable everything
that's happening today we predicted it
last year you know it's not this isn't
like rocket science or the variance and
all those kinds of things
so the fda we can start to understand
why but also like
one question i want to ask is it
possible to go around the fda yeah
so why has the fda not changed
and why has nobody tried to push the fda
to change like
the i think what the real reason is the
fda
has one job around these tests and it is
to authorize them as medical devices
they haven't been charged with doing
anything else
so in their eyes they're doing exactly
what they're supposed to do
they're evaluating these tests as
medical devices and they're telling
company after company after company
sorry you don't make the cut
and the only way to make the cut is
really to kind of skew your clinical
trials to favor
the rapid test being positive which
isn't really good practice we shouldn't
be trying to skew clinical trials
but that's kind of what's happened
that's been it's been forced upon the
companies to do that
and so
i think the fda truly believes from the
bottom of their heart that they are
doing the right thing here
and i would argue that to an extent they
are i've been pretty hard on the fda but
maybe the issue is a higher level issue
like the the in vitro diagnostics
division is
they get applications and they evaluate
them and the applications are for
medical claims
that's however because there's been a
misunderstanding of these tests and the
companies only know to apply for these
as medical claims
because there is no
there's nothing else in this country to
apply for
except the medical claim
so we we don't have a public health
pathway to evaluate a test and authorize
a test it doesn't exist we have
defunded and devalued public health for
so long
that we literally don't have a language
for it we don't have laws a language
words is it called a public health test
is it called something else i call it a
public health test because i'm trying to
create a new definition here
but that's why
that's why nobody's acted because no
because everyone says well there's no
other pathway so the fda
in vitro medical diagnostics division is
the only pathway so what i am trying to
do
is to say look
the fda very clearly states
that they do not authorize or review
public health tools
and not and they don't authorize or
review public health tests for for covid
so
what i want the president of the united
states to do is to utilize executive
powers and take an executive action that
can simply state like one line one line
could potentially
change all of this
and it's a pretty obvious and simple
line and it is that
any tools
used for public health
testing during this public health
emergency
will be designated as public health
tools
like it's obvious like it's public
health emergency it's a tool used for
public health it should be designated as
a public health tool
if we can do that if we can get that
language out there so that that's the
president's decision
then all of a sudden the fda is off the
hook
they're not trying to to cram a square
peg through a round hole
they can say look the antigen tests are
not on us anymore at least if they're
going to be used for public health like
when you test a thousand people at a
time or
test a school a school classroom if
they've been exposed this is public
health and so then the cdc could take it
over
the cdc could say okay
what are the metrics we are interested
in
and they could say we're interested in a
test that can catch you if you're
infectious so you want high viral load
detection that's fast that's scalable
and hey you know if your test has been
used in europe for months and has
performed extremely well
then then we'll give you a certificate
by right you know immediately and that
could actually get
hundreds of millions of additional tests
into the united states tomorrow
so you need some kind of classification
from an fda from somebody to call it a
public health tool in order for it to be
manufactured is it possible to just go
around all of this and just for somebody
to manufacture at scale
tests
well
you if you did that and you just called
them you put a claim on them that called
them public health tools
the fda has a very
weird view of this and they will tell
you that it's illegal that it's a crime
is there a way to say like elon musk did
with the flamethrower it's not a
flamethrower yeah
uh believe me i've tried i've tried to
think of all the different approaches um
you know there's weird there's like
there's major inconsistencies here so
it's not like we don't have a precedent
for a public health test even during
this pandemic
there is a very strong precedent
uh pooled testing
we have companies like ginkgo right
based out here in cambridge
that are
uh
you know working with 100 different labs
around the country so that might mean
like not a ton of quality control over
those labs
doing
uh i mean i don't want to say that they
don't i'm just saying the reality is if
you're working with that many labs it's
hard to say they're running pooled
testing
of millions and millions millions of
kids
so here you have a company that's
testing
in each pool five to 25 kids at a time
millions of kids in a pretty distributed
way across the country and all these
different labs
and the fda doesn't care at all you
don't need any ua it doesn't need a
regulatory authority
it's collection on site it's getting
shipped to a lab there's no oversight of
it
so why does that have no oversight but a
rapid test for pub for the exact same
purpose
you're just giving people immediate
results instead of two-day delayed
pooled pcr results so it's a much more
effective tool
why is the rapid test used for the same
purpose
not designated as a public health tool
but requiring
fda authorization
it's a ridiculous reason
and it's because the fda says that if a
test
and this is actually cms that says this
and then the fda adopts it
if a test alters your
behavior if you get a single result and
it's going to alter your behavior
then that is a medical device
but
the thing that i find ridiculous is like
okay but you can give a pooled test that
alters 25 people's behavior at once
and that's not falling like that's more
risky one person turns positive in the
pool and 25 people have to be
quarantined
and uh how do they evaluate the accuracy
so for people who don't know a pooled
test
is you're testing a small fraction of
the people
and
if one of them is positive then you
basically say we have to retest
everybody in the pool or like you yeah
so you take let's say you have a school
and each classroom you might have 20
kids each swab their nose in a classroom
and all those swabs go into a single
tube
and then you rinse that tube out with
some saline and you run a pcr test on
that tube of 25 samples or 20 samples
and so if that tube turns positive in
the pcr test
then all 20 or 25 of those students
are now having to quarantine yeah and if
there's no positive then all 20 or 25
students are
interpreting that their result is
negative
you know so it really is ridiculous
decision by the fda to say that
if the test itself only tests one sample
at a time it's medicine
because it will tell you one person at a
time if you're positive or if you're
negative but if you do it as a pool and
you and you
tell 25 people that your pool was
negative
then that's somehow different that's
public health not medicine it it doesn't
make there's no logic there was it just
personalities and accidents of history
or something like that for example
you talk about the
public health tools and cdc you look at
masks
so masks were decided to somehow be an
effective tool
to help with the pandemic like so i'm
sure the evidence that was used there
was probably not as strong as the
evidence supporting antigen rapid tests
i was
very much reading a lot of research on
masks it's tricky it's really tricky to
show how well they stop the transmission
of a virus especially when you don't
fully understand how the virus is
transmitted or the viral load required
all that kind of stuff but then the cdc
pretty quickly decided masks or whatever
there's some oscillations back and forth
but then they quickly decided all
everybody decided masks is a good tool
so masks being decided a good tool and
then
rapid antigen tests not a good tool is
that just like certain personalities who
didn't speak up in a meeting or who did
speak up in a meeting is this just like
a weird role of the dice or is there a
better explanation
i think it's somewhat of a roll the dice
but i also think it's that testing
so
doctors
don't pretend to like really understand
much about like
fluid dynamics and you know how well
masks are working like that's like way
out of their realm
doctors
do believe that they understand all
aspects of the tests right
and so the greatest barriers to rapid
tests being brought to market or sort of
being being rolled out heavily and
supported as public health tools
uh the greatest barriers came from
physicians saying
hell no we can't use a test that's not
as sensitive as a pcr
and
look at what happens if you use this
antigen test and not a pcr test you get
people
who are showing a positive on a pcr
negative on an antigen
and they just assume that that was a
false negative on the antigen
for public health i would call it a
false positive on the pcr test but this
type of thinking
literally does not exist in medicine and
i think the biggest problem here is that
we
placed physicians in decision making
power
we have
won this pandemic hit everyone called up
clinical uh laboratory folks and
microbiologists
and physicians to ask well what kind of
tests should we use that kind of thing
and there is no training in medical
school for this kind of public health
work like uh you have to optimize on the
right qualities of a test
that have nothing to do with medicine
and then sometimes if not frequently
they're actually at odds and i'll give
an example
why the physicians you could see why the
physicians would have been against it
from their perspective
and they say uh if a physician is a tsa
agent
at the airport
you know a tsa agent their role at any
given time
and the role they think that the
instruments need to play is i want you
to scan the bag as well as possible this
is the only bag that i'm interested in
at the moment
and this is my lane this is my bag
i want to make sure that my instrument's
doing i don't want the crappy instrument
in my lane i want to make sure that i'm
doing everything i can but
what those tsa agents don't have to
worry about is well how many other
instruments are there in this airport is
anyone getting through
the lines here without going through
security the average tsa agent doesn't
have to worry about that they literally
have one job to do and it's pay
attention to this lane
if there's a big gap in the security
line and people are flowing through
without going through security that's
not on the tsa agent that's not a big
systematic problem of that of of the the
system
and we can't expect that tsa agent to
have ever even thought about that like
that's not on them they were trained to
look at a to look at the bag
and that's kind of like physicians
and i you know probably some physicians
will hear this and feel like i'm
insulting it i don't mean to be liking
you know the two professions and or
anything like that i what but the point
is is that
a physician has one duty do no harm to
this patient
time isn't of the essence scale how many
tests can my hospital perform in a day
how many tests can my county or country
perform in a day that's not a
physician's training to think like that
at all
and so what has happened is doctors got
on board early and said oh hell no we've
seen these antigen tests before they're
not particularly sensitive compared to
pcr and and early in the pandemic there
was like pissing matches between labs
who had the most sensitive pcr
and it just
distracted everything it really i was
trying to say pretty early like
we don't need sensitivity we just need
frequency we just need scale we need to
think differently because our only goal
if we're doing
frequent routine testing of asymptomatic
people
is not medicine it's to say do you need
to isolate now
and if you have a pcr test that's taking
three days to return and you're like if
i was currently spreading virus before i
walked in here
and you handed me this actually happened
to me today when i walked into harvard
today was my first day back into harvard
since february of 2020. i go in i
scan my badge and they they hand me a
pcr tube and they says they say like
return this you know by
noon or something before you before your
work day's done
and i'm looking at it i'm like
what is this going to do like what if
i'm super spreader right now yeah you're
giving me free reign to walk around and
infect everyone in the school
and you're gonna give me my result to
tell me i did that in two days from now
it doesn't doesn't really make sense so
who is supposed to be so it's
understandable that doctors kind of feel
that way just like you said do no harm
who's supposed to
care about public health
is it the fda is there some other
organization yet to be created
is it like uh just like with the
military the reason we have civilian
leadership when when you talk about war
is it the president that's supposed to
do like override fda override doctors
override
and basically politicians in
representing the people in the state of
emergency make big public health
decisions like who is supposed to do it
besides you on twitter
it's like
most people really thinking about
solutions to kovid
we'll mention you or will mention this
idea of rapid home testing
and it's it's you watch that happening
this discussion that this is an obvious
part of the solution and the solution is
not happening
so who is supposed to implement this
idea
i think the cdc that it should start
there
override the fda
well i don't even think it needs to
override it and that's why i think these
should just be designated as a different
tool
so that the company is it's not
overriding it's just saying look this
isn't even this isn't in your
jurisdiction to the fda this is just a
a public health tool but the problem is
the centers for medicaid medicare
services designates any tool just like
fda they designate these as medical
devices purely because they could change
somebody's behavior based on the result
of one test
so to change that at this point unless
you get cms buy-in you know we don't
have there is no designation as a public
health tool
but the president
can just say
these are public health tools these are
not to be
regulated as medical devices if their
goal is not medicine but public health
and if he does it he does have the
authority to do that as president and to
say
i'm tasking the cdc
to certify these tests or or authorize
them for use in the united states and
you know he has to say something like
that he can't come out and say these are
public health tools have free reign
just you know any company start start
shipping them in the us because that
would create pandemonia and we'd have a
lot of bad tests
but there's a lot of really good tests
out there we just are taking like 6 to
12 months to run trials they're failing
because they can't keep up with pcr
and
if the president were to do this then
the cdc could take it over and they
could say okay
it's on us we're going to decide
the uk actually did this they
early on they said okay
they laid out a very clear regimen they
said this is how we are going to
evaluate
rapid antigen tests because they're
public health tools they did it in a in
a domain that was outside of their
normal medical diagnostic regulatory
agencies
and they they literally just had
a very fast screening to say what are
the best tests they went through a huge
number of different tests they said okay
these are the this is the rank order of
which tests are good which are bad which
are scalable which are not
and they were able to start deploying
them in weeks not years so i think the
cdc really needs to take charge the
problem is when it comes to like law
if everyone currently perceives this as
like
fully within the domain of the fda and
they've never heard of such an uh public
health
test idea enable it but but the fda
itself has created the idea by saying we
don't regulate public health tools
so the word is out there the fda has
said we don't regulate them so that
gives the president an opportunity to
say okay
these are those you know these are
public health tools by definition
and and i do think that this is a kind
of a crisis and it's a crisis of testing
but it's also a crisis of like
really we're going to go through this
whole pandemic and never figure this
thing out
that's just really sad you know if we
get through this and don't figure out
how to evaluate a damn rapid test
so
how do vaccines
play with this so one of the things that
when people discuss solutions to covid
there's a sense that
once you have a vaccine kova dissolved
so how does that interplay
like why do we still need tests if we
have vaccines yeah i am i actually wrote
an op-ed in
new york times or wall street journal or
something that was titled why we still
need rapid tests with with vaccines
and
the real reason is because we have
evaluated our vaccines based on their
ability to stop disease
in fact most of the trials didn't
evaluate them based on their ability to
stop transmission
they didn't even evaluate that at all no
less put it as one of the metrics for
authorization
and
with a virus like this it would be a bit
naive to think that it's really going to
stop transmission well
i think a lot of excitement happened
right after the first clinical trials
and i'm sure we were talking about it
when when i was last here i would
imagine given the timing
but those first clinical trials came out
and everyone
you know jumped for joy that these
things were going to be the the end to
this pandemic
but we had really short-sighted vision
there by not recognizing two main
features one is
uh that they might not stop transmission
another i guess three another is that uh
new variants might come around that will
break through the vaccine protective
immunity and the third is that we
were not
we were measuring the efficacy of these
vaccines during the peak of their
performance in the first few months
after people got vaccinated
and that gives a skewed view of just how
effective these are going to be long
term so what happened
with the vaccines is that
everyone got very comfortable this
including the cdc saying
if you've been vaccinated you know this
is the end of the pandemic for you
and let's keep it up
but then delta comes along and waning
immunity comes along and both of these
things compound exactly as anticipated
to get breakthrough cases
and unfortunately what we're seeing now
is the cdc and the administration went
so all in on saying that
breakthrough cases are rare that
transmission doesn't really happen if
you're vaccinated without great data
especially with delta that once people
started seeing breakthrough cases
they start interpreting that as a
failure of the vaccine the vaccines are
still working to keep people out of the
hospital
for the most part
but
they're not working to stop transmission
and if our goal is to stop transmission
which until we decide as a society that
we have different goals
like we're okay with people getting ill
and letting transmission go because we
don't want to worry about it anymore
we're not there yet so until we decide
we're not going to stop transmission we
need other avenues besides the vaccine
because it's
it's not doing it it also means that
herd immunity isn't going to happen and
unfortunately as long as we keep letting
spread happen in the context of
vaccinated people
we're kind of giving this virus a boot
camp of exactly what it needs to
do and mutate to get around our
vaccine-derived antibodies that makes me
very nervous so the more we can do to
stop spread
in the unvaccinated in the elderly
vaccinated and in other people
the better we we just should be focusing
on that so in your eyes the solution
would look like this
you would have make enough tests where
every single person would get tested
every single day
i think that that would be
i don't want to do that actually i want
to do a variation on that i think what
we should do is have a dynamical testing
program
it doesn't have to be
complicated
it's every household has a box of tests
in their cupboard
and if you haven't seen any cases in
your community for a long time stop
testing do waste water
testing to see if there's any rna coming
back
if you start to see rna in the waste
water that represents the virus and
you're still wanting to stop outbreaks
you say hey
you know those tests that are in your
cupboards households in this county
why don't what is in each household or
each person each household use one test
per week
and can you uh sorry to just pause
on that idea that's
really cool the the waste water testing
that's the thing so you can you can get
a sense of how prevalent the virus is in
a particular community by testing the
wastewater that's exactly right and so
the viral load associated uh the viral
load that you can find in the community
represents the prevalence of the virus
in the community which is really quite
nice that's not that's a nice way to
paint like a map of the
the intensity uh of the virus okay so
when it
when it goes above a certain level
you can start
doing
much higher frequency testing per house
in each household that's right so i
don't want people to be in testing
purgatory like that's not what i want i
just want us to get through this damn
pandemic and
and so we can monitor the waste water or
any other methods we can monitor the
hospitals in the clinics and if somebody
does come in with coveted like symptoms
and then a few other people come in you
realize okay we got spread happening in
our community
send out a text message put it on the
news put in the newspaper whatever you
need to do
tell people tell families use your test
and if the cases get worse
because you're just doing it once a week
that's not going to stop transmission
but it's going to enable you to identify
where outbreaks are happening
if you start to find outbreaks in
pockets
then the rule is simply okay let's
squash the outbreak real fast so
everyone in that area uncertain zip code
or whatever it might be
test every two days
you know for seven days or every day for
seven days
and you'll get rid of the outbreak
we can do that and if you've now gone
again you know a week or two with no
cases
uh identified stop the testing again
that's the nice thing that
everything changes when people have the
tests in their home
it becomes
dynamic it can become easy send a text
message take your test today
if some people don't do it that's fine
the only goal
is to get r below one and you stop the
outbreak
people think it has to be near perfect i
always hear people say
ah what if somebody doesn't doesn't use
it or what if somebody lies like well
you you have 98 of people testing or
even 50 that's a whole lot better
and you know another big difference that
people i think often times have their
have a problem wrapping their head
around
especially to the extent
physicians who are used to really
like who are used to different kinds of
metrics is that
all we have to do to completely stop an
outbreak from spreading in a community
is to get for every hundred infected
people
to get them to go on and infect 95.
most people would say oh my god that's a
horrible you know that's a horrible
program you're still letting a hundred
people go and infect 95 people
but that's for a virus like this that's
a massive public health win if you can
get 100 people to infect 90 most people
doctors i would say like a lot of people
would say that sounds like a failure to
be honest
but if you do that for multiple days in
a row
then in a couple of weeks you've gone
from a big outbreak to a very very small
outbreak
and on the other hand if you don't do
that if you allow 100 people to just
infect 140 people
because you're not doing the testing
then instead of having 20 people at the
end of those four weeks with the testing
you literally would have 600
massive differences here
and all
the only goal then is to get our below
one have 100 people in fact less than
100 and you stop the outbreaks and
everyone stays safe
from everything you've seen how cheap
can these things get from like in the
past year
in in terms of the developments you've
seen with the various test manufacturers
how cheap can it be to make a test to
manufacture a test so there's the
manufacturing process that could be 50
cents maybe less
it's hard to get it's hard to really
have eyeballs inside these companies you
know in terms of where they're producing
them in china
and taiwan a number of other places
some of them are produced here in the
united states too but 50 cents say it
was a very very reasonable generous
number for how much it cost per test
you look at a place with high market
competition that has actually authorized
a lot of these tests like germany
germany has 60 70 some different
companies of high quality rapid tests
authorized
you can go there and buy it for 80 cents
you know that's and they're still making
profit and so
so it's extremely cheap market
competition can drive these tests
uh way down in terms of cost
i think one of the most important
features
of a rapid test program is what do you
do with the result is it going to
be used for you to gain entry to school
or work
is it going to be reported to the public
health agencies
you know all of these the primary mode
should be just get people test but
really if you're going to be using it
for a workplace thing like what biden is
now saying vaccinate our test which is
going to lead to a crisis if we don't
fix this soon because we're going to
massive demand for testing in the next
couple weeks
but when he says that that's essentially
saying okay companies need to make sure
that their people are testing so are you
gonna base it on the honor system
i would say you probably would not base
testing on the honor system if it's like
to uh take somebody who would otherwise
be quarantined from in school and so you
can go to school as long as your test is
negative so test to stay program is a
big thing that i've been pushing for and
others have
businesses bringing people into work who
need to test
they need to have verification
but they don't want to like set up
nursing stations in their lobbies or in
the school parking lot or whatever like
everyone's tired of that we need to
bring the test into the home but that
means we need the technology to enable
it
and so i was at a conference recently
do you know mike milken milken institute
he's a
very wealthy billionaire but he's done a
lot of philanthropy and he hosts a
conference to raise money for prostate
cancer
research i was at this conference
recently francis collins a number of
other people were there
and every morning we all had to test in
the morning which i thought was a great
idea obviously before we walked into
that conference
and um but you didn't have to test there
and they didn't base it on the honor
system every morning i'll i
scanned a qr code on the box and emed
which is a service that provides
test uh verification
popped up with a proctor right on my
phone or on my computer
and said okay
let's go through your tests like and
they watch you they videotape you using
the test so it's all recorded it's all a
reportable
type of test
and at the end of it just from your home
you don't actually see the proctor you
know they're but they're just verifying
that you actually do it
they verify the test they verify that
test results with you
and at the end of it you've then gotten
from from your couch or from your car
wherever you are
an actual verified laboratory report
that can be
considered proof that you yourself use
the test and you yourself got a negative
so the tools are out here
if we want to use them at scale and in
fact the cdc uses emed now to
enable people to come back into the
united states
uh through an antigen test so before you
get on your flight you're sitting in the
airport in heathrow or wherever you are
you can get on your computer use your
emed test
and you get the negative and that and
cdc will accept that tsa will accept you
to come back into the us with the rapid
antigen test that you did without anyone
else watching except for this proctor on
your phone super simple
how much private information is being
collected so like this you know people
have
in the united states
the american way they have a hesitancy
on the overreach of government in things
like vaccine
passports
like using
any mechanism any mechanism of
verification that's controlled by
government can lead to overreach by said
government so there's a concern of that
do you
see there a way of achieving
testing that's verified but does not
violate people's privacy or sense of
freedom
absolutely i i think so the way that
um right now in the united states
they're requesting that
these tests get that the results get
delivered to public health agencies but
i've long held that
while that's ideal it should never be
the thing that holds up somebody being
allowed to know their own status
but if you are going to work
and you have to let your boss or your
manager whomever know that you were
negative that day or if you're going to
school
i think it's going to be hard to
maintain complete privacy
in that situation because they need to
know your name but sure i mean could you
cut off the public health reporting
yes you could but i worry i mean can you
opt out maybe you could opt out that
should be a feature i want to opt out of
the public health reporting because
for whatever reason otherwise i'm not
going to do the test and but that means
that okay then you're not going to go to
work so right now there's this serious
tension and
i am very uncomfortable with
the idea that we force anyone to do
anything but
there is a tension between these two
things for sure and how do you balance
that during a public health
emergency
i think first and foremost let people
everyone has a right to know their
status
the fact that we have made it hard for
people to know their status on their
terms i think is a travesty i mean it's
just so
terrible that we have
prioritized
us knowing at the expense of you know
essentially what like elta's long said
during this pandemic is
if i'm public health it's if i can't
know then you can't know your status
like that's not the right way to look at
public health we need to engage the
public and if some of them don't want to
participate in the public health part
but want to know
their status
by default they are participating in
public health whether they know it or
not because they're not going to go get
their mom sick by mistake
at least most people wouldn't and then
also you can create systems where
you can
individuals can form relationships based
on their status
without ever reporting it to a
centralized place so
you can go to i don't know
a local business owner might
require that you show
that you're negative
but that doesn't require reporting it
you can
like there might be um basically like an
id
that's only in possession you are the
only person in possession of that so you
literally show it exactly here's a test
i took it's negative and nobody else
knows about that test so that could very
well be done even through a company like
e-med i think
and i might be wrong here
uh i believe that they take the test
result and because they are considered a
clia waived laboratory like a digital
laboratory
they report their results by law out to
uh the public health agencies
but let's say there was something a
little different let's say you were
verifying an over-the-counter test
and it doesn't have to be a cleo wave
because it's over the counter then
you're not bound by clio rules
and
you could create the same service but
that just doesn't report out to the
public health agencies it gives p