FDA Direct Ep. 4: To Boost or Not to Boost – Gathering New Evidence on Covid Boosters
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We don't even need a countdown.
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We're going raw and live.
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Good to see you.
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Good to see you.
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Vanay Prasad and
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Sanjula Jain-Nagpal.
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Great to have you here.
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And of course this is a conversation.
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It's just not a show
or a really a podcast.
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It's just a conversation.
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We were in my office chatting and we said,
hey, let's just walk out to the chairs
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and just have this conversation
on the cameras so we can be transparent.
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And the glass box that we are.
You know, I've gotten so much positive feedback
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from these conversations.
There is no script.
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This is all extemporaneous.
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I don't even know what you're going to
ask me sometimes and catch me off guard.
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I don't know what I'm going to ask.
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You don’t know either. So that’s good.
That makes two of us.
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But I think people really appreciate
these conversations because too often
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the FDA was completely opaque,
that black box.
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And now we're just having
these conversations on camera,
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talking about whatever we're
working on this week and into the future
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and letting the American public know
directly our thoughts on that.
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And there is the FDA,
with all the scientists busy at work.
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And it's just been awesome getting to know
so many of them.
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Really impressive
people, brilliant people.
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I mean, I have learned
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I made the joke that I learned more
in two weeks than I learned in two years.
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I mean, you're talking to people
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all the time who are educating me on topics
that I had only scratched the surface on.
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And you think, you know, a topic deep.
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You, we’re depths beyond that.
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There's oceans beyond that.
Oceans of some specialization.
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And it's it's kind of cool.
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It's kind of cool. It's
an intellectual feast, Sanjula.
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That's for sure.
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I mean, yesterday alone, I mean,
I was just thinking on my drive home,
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I mean, I learned so many things
that I thought I knew
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something about just a little bit
and completely changed my mind.
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And I'm excited
to talk about some of that today, too.
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And the vaccine framework,
which has been out now for a day.
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So we've been absorbing what
some of the response and feedback to it.
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And it's been, I think overall very positive.
How would you describe how would you
describe it?
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I’ve been inundated with emails.
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You know, emails, text messages,
phone calls from,
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you know, all of the doctors
I trained with at University of
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Chicago and Northwestern
and the National Cancer
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Institute, OHSU and UCSF
as well as my European colleagues.
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And I would say the overwhelming majority
are telling me, boy,
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finally, a return to a common sense,
evidence based framework.
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You really struck the perfect balance
between making the product
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available to a huge group of Americans,
but also getting the evidence we need.
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And I think they think
we provided the needle nicely
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and we are now no longer
a contrarian nation.
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We're in line with all of Western Europe.
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The European doctors are like,
what took you so long?
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My Canadian family members are
finally like, great, now
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I don't have to think about
what's different when we come visit you.
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We are no longer an international outlier
in regulation of Covid vaccine boosters.
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Yeah, but Vinay I have to commend you.
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I mean, the way that you presented
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the framework really struck
a great balance of kind of that scientific
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technical discussion, but also in a way
that my grandmother could understand,
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like those figures in the paper
were really helpful
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because I've been following
both of your work
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for years, and even for me,
a lot of things really connected.
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When I heard, you know, you presented
yesterday, it just it made so much sense.
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I am like,
wow, how did I not know this before?
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Well,
I think it's really kind of you to say,
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and I've actually learned a lot
from watching Marty over the years,
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because I think he's been an expert
communicator
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from even before I was in this business.
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But I think it is something
you have to work at, which is that
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you go from talking to scientists,
where you speak a certain way, to
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trying to make that more accessible,
to everybody, which means
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take out the jargon, substitute,
you know, plain words insofar as possible.
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Try to make simple visual images
that walk through the core of the problem.
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You know, as simple as possible,
but no simpler, you know?
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And that's what we were trying to do
in that talk.
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I mean, to your point
about learning every day,
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I mean, even though I'm in this world, I'm
less on the clinical side.
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I didn't know when the endpoint was
until yesterday,
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and I finally understood the difference
between surrogate and non-surrogate.
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Oh, wow, that's a big bomb
you just drop there to the world.
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Right.
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The way you explain it.
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And so, so a lot of great enthusiasm
for the framework.
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I think a lot of the scientific community
is really celebrating.
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Wow, we're finally following the science.
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But, you know, I was scanning some
of the various headlines and, you know,
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and there's always, you know,
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there's always going to be critiques
and pushback.
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In both directions. I'll have, you know.
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I mean, I saw some people
saying, like, what's wrong with them?
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They didn't yank all these shots
off the market tomorrow? Yes.
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Or some people saying,
what's wrong with them?
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They're not giving us a booster
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every six months in perpetuity
for the rest of our lives.
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Yes.
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So in some ways, all great compromises
make extreme positions unhappy.
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And it's the nature of compromise
and pragmatism is
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that we're aiming for the middle
for most Americans, you know.
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But by my assessment
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there's kind of kind of two themes
of those comments
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where there's kind of two camps
that I think are emerging.
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One is I would call kind
of the blind boosters in perpetuity.
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So let's call
that kind of the blind strategy.
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And the other is more of
that kind of evidence based strategy.
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Right. Would you
would you both agree with that?
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Yeah,
I think we're in the evidence based camp.
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I mean,
I think the idea that we should recommend
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a booster for healthy people
in perpetuity, that is a young girl
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born today in her average lifespan,
will get 80 of these Covid boosters.
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That is a theory, okay.
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And with hepatitis B,
the number ends up being 2 or 3.
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With HPV, the number ends up being 2 or 3
depending on your age.
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With MMR, the number ends up
being two in the United States, one
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in some other countries.
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And so, somebody can make an argument
just to keep going
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with MMR annually
for the rest of your life.
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But there's a general recognition
that you sort of optimize
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your cellular immunity
after a certain number.
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And so there's still a scientific unknown
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that is, is the blind boosters
in perpetuity with no clinical trial.
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And, and and let's be honest,
that's what people some people
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are suggesting
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we do not do any more randomized trials
and just keep going forever
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in infinity with boosters every year.
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There's so many problems with the blind
boosters in perpetuity strategy,
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which I guess is a nice way
of putting
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what had been the status
quo for a long time.
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Among those problems is why
only once a year?
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Why not every three months
or every four months or every six months?
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And why not 18 months?
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You know, it's also sort of random.
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And as you point out, there are no
clinical trials that guide us.
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And they really would have us take
this young child and throughout the course
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of their life, receive dozens and dozens
and dozens of Covid boosters.
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And we'll have absolutely no clue
if we make such a person better off.
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But, you know, here's here's what really?
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That's how dogma is born, by the way.
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It's where dogma comes from.
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And, you know, a lot of the people
in that category are, people
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who don't have the daily task of being
a primary care doctor, seeing patients.
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Let me tell you what
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one primary care doctor wrote to me
and said, you know, you just
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you're finally getting how difficult it is
to walk into an office
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and you're sitting across from someone,
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and I'm a 42 year old doctor
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and the 42 year old patient, and he has no
reasonable, average, low risk person.
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I'm a low risk person,
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and the patient tells me, hey, doc, do
you think I should get a Covid 19 booster?
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And I'm like, shucks,
I don't even know if I should get one.
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And truth is, I haven’t the last couple of years,
you know ...
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I still can't believe he's 42.
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I want to know how many peer reviews,
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how many peer reviewed scientific articles
have you written?
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Something like 540 something?
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You know what?
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I thought it was working
hard and I went to work for this guy.
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Now I'm working around the clock.
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We like to work hard here.
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They're working hard.
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So we're going to work
hard to support him.
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I think that's that's something
I've learned, which is that
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people truly are working 6 a.m.
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to late into the evening.
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I mean, if they're not physically here,
they're working on their computers,
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they are sending emails,
they're doing stuff and
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It takes your full,
it takes your full talents
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as a doctor and a scientist
to try to keep up with people here.
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You know, I think everyone signs up to be
a doctor or a scientist to work hard.
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I mean, these PhD programs are grueling.
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They're long, they're hard.
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Medical school, residency, same.
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And so I think generally
that type of person loves hard work.
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And for me, there's no better heaven
than to be surrounded
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by people who love to work hard
while we're here on earth, by the way.
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And so it's
so that's an exhilarating feeling.
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But there is tremendous value
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to being at the bedside
and having to explain this to patients
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and the blind boosters
into infinity group that
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that group in America and healthy people,
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they are also in denial
that there are significant claims
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of vaccine injury that have not been
thoroughly investigated.
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I can't tell you
how many people have told me.
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They just have, some residual effects
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after they got the vaccine or
something happened immediately afterwards.
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And you can't make a direct
causal association, but it's suspicious
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enough
that you hear enough of these stories
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and you think
maybe there is something there.
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Why else would an otherwise healthy
35 year old woman suddenly develop,
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a diagnosis immediately
after in the weeks afterwards.
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So, again, you know,
we have to use the scientific approach,
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but there are hundreds
of thousands of Americans
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that say that they have been
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vaccine injured, and those cases
are not being investigated.
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Yeah. So I'd say that.
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And now I'm, I'm, I'm, privy
to lots of information that I,
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that is confidential
that we're working through.
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But I do think that, in, in our group
in CBER we take it extremely seriously.
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We take these things very, very seriously.
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And we start with what you talk about
people's anecdotal impressions,
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what they experience
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and what kind of the claims
data and provider data and our vaccine
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surveillance system data.
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And we're trying to look,
is there a statistical signal there?
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And these methods are,
you know, work in progress there.
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There's a tried and true part to it,
but there's also this sort of
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the bringing in real world data
and expanding our methodology
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and getting better at these things.
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And I think we have to be honest
that lots of vaccines out there
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have really good efficacy safety profiles.
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And we, have approved those products.
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And, those are important products.
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And there are other vaccines where we are,
still learning
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more about safety signals.
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And I think we will better characterize
some safety signals in the future.
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It's a it's a living thing.
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I mean, vaccine safety and all drug
safety, it's not a static thing.
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It's always kind of a work in progress.
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You're always learning a little bit
more.
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Real time. The nice thing about data
that I think it's also worth
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kind of we've been having
a lot of discussions about
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how do we improve our data sources to be
able to do more real, real data analyzes.
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And so I just learned this couple
days ago, did you know we have about six,
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I believe 6 or 7 different adverse
reporting data tracking systems.
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Oh yeah. Each one
their own clunky database.
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Their own clunky website.
And all these crazy funny names.
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VAERS, FAERS, AERS.
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And then there’s MAUDE. One that
doesn’t rhyme with them.
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Yeah. Right.
233
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I come from a data world. Right.
234
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And so we think about, you know,
the power of being able to really track
235
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a lot of these things.
236
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We have to be able
237
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to connect these systems and see,
you know, the way people are reporting it
238
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I didn’t know this. You could do it
239
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you know, email. You can send a letter.
240
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You can phone call. Right.
241
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Different inputs that we're getting in.
242
00:11:14,206 --> 00:11:15,007
And so we have to be able
243
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to really put that all together in a way
so that we can see this stuff at scale.
244
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And we're going to do that.
245
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We're going to do that.
I mean, it makes no sense.
246
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These giant clunky databases,
you could spend an hour trying to report,
247
00:11:26,252 --> 00:11:29,588
you could spend over an hour trying to
get data out of it and put a request in.
248
00:11:30,022 --> 00:11:31,424
They're not transparent.
249
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It's so messy.
250
00:11:33,392 --> 00:11:37,163
And the reason
that there are so many different clunky
251
00:11:37,163 --> 00:11:40,166
adverse event reporting systems at the FDA
252
00:11:40,466 --> 00:11:42,935
is that it's been a fiefdom culture.
253
00:11:42,935 --> 00:11:45,938
Each of these centers
has built their own from scratch,
254
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and we're going to change that.
255
00:11:47,573 --> 00:11:48,574
We're creating teamwork.
256
00:11:48,574 --> 00:11:51,210
One of the core values of this new FDA.
257
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We're going to consolidate,
especially in the IT world.
258
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We're going to make these user friendly.
259
00:11:56,615 --> 00:11:59,952
And there's no need to have entirely
different databases,
260
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for devices and drugs.
261
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When you could have one toggle question
at the beginning
262
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and a user friendly experience,
just like if you use, you know, PayPal
263
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or any other app out there,
I think it's a no brainer.
264
00:12:12,298 --> 00:12:16,535
Like it's a win win situation, harmonize
these adverse event reporting systems.
265
00:12:16,802 --> 00:12:20,206
I mean, to some degree,
you know, I'm always, appreciative.
266
00:12:20,673 --> 00:12:21,741
I'm always appreciative
267
00:12:21,741 --> 00:12:25,144
whenever I see a paper from Denmark
or Sweden on adverse events.
268
00:12:25,411 --> 00:12:29,181
But I'm also kind of pained that,
why don't we have systems that robust
269
00:12:29,582 --> 00:12:32,284
and tie together
so neatly that that we can't do that
270
00:12:32,284 --> 00:12:35,020
the United States and I think
we are moving in that direction
271
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to having that kind of system
where we will be
272
00:12:38,190 --> 00:12:42,495
the dominating force in characterizing
and documenting these events.
273
00:12:42,495 --> 00:12:46,432
It’s so frustrating that we're always behind
274
00:12:46,499 --> 00:12:47,399
these other countries, right?
275
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We're supposed to be the leader
in all of this.
276
00:12:49,168 --> 00:12:50,402
And so to your point about now,
277
00:12:50,402 --> 00:12:54,573
we're no longer the outlier on our policy
here and our data systems.
278
00:12:54,573 --> 00:12:55,808
We can't do that kind of research.
279
00:12:55,808 --> 00:12:58,577
I mean, we have to get back on track
and get ahead.
280
00:12:58,577 --> 00:13:03,549
We were kind of dug in
into the blind boosters,
281
00:13:03,549 --> 00:13:08,254
into infinity every year without any more
clinical trial and randomized data.
282
00:13:08,254 --> 00:13:11,257
We were kind of dug in as a government,
283
00:13:11,524 --> 00:13:14,527
until this new framework
that you, outlined.
284
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And.
285
00:13:16,162 --> 00:13:19,932
Yeah, and to your point also,
I want to just note that in many ways,
286
00:13:20,232 --> 00:13:21,700
we are still the best in America.
287
00:13:21,700 --> 00:13:23,402
I mean, we're
the place of biomedical innovation,
288
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the most research,
289
00:13:24,670 --> 00:13:26,839
the most research papers,
the the most publications,
290
00:13:26,839 --> 00:13:28,941
the creme de la creme,
biomedical research,
291
00:13:28,941 --> 00:13:32,611
the most, innovative companies
driving the most innovation.
292
00:13:32,778 --> 00:13:35,848
In fact, the globe looks to us
for their innovative products.
293
00:13:35,915 --> 00:13:37,249
And everyone looks at the FDA.
294
00:13:37,249 --> 00:13:39,251
The FDA is, in part,
the FDA of the United States,
295
00:13:39,251 --> 00:13:42,054
but so many countries
essentially rely on us. Yeah.
296
00:13:42,054 --> 00:13:45,691
And so I think we are
in, in so many respects still the best.
297
00:13:45,724 --> 00:13:46,392
But you're right,
298
00:13:46,392 --> 00:13:48,160
there are places that we could get
even better
299
00:13:48,160 --> 00:13:50,663
and bring it all up
to the excellent level.
300
00:13:50,663 --> 00:13:52,832
And you're right,
the blind boosters in perpetuity.
301
00:13:52,832 --> 00:13:55,501
It was just taken, for granted.
302
00:13:55,501 --> 00:13:58,637
And so many things in, in,
you know, in, in government,
303
00:13:58,637 --> 00:14:02,208
in bureaucracy and big institutions
are just we used to do it that way.
304
00:14:02,208 --> 00:14:05,845
So we’re always going to do it that way
without taking a step back and thinking,
305
00:14:06,011 --> 00:14:08,180
does that make sense?
Is that the best way?
306
00:14:08,180 --> 00:14:10,816
Is it
evidence based, is it common sense based,
307
00:14:10,816 --> 00:14:13,452
and all we're doing
is shifting towards that in this space.
308
00:14:13,452 --> 00:14:18,757
And in fairness to the blind
boosters in perpetuity camp
309
00:14:18,757 --> 00:14:23,395
The BBPs.
Is in fairness to that, that that group,
310
00:14:23,863 --> 00:14:28,167
they did look to influenza and said, well,
we got influenza,
311
00:14:28,434 --> 00:14:32,605
but influenza has had over 41 clinical
trials.
312
00:14:33,205 --> 00:14:36,208
Influenza has an 80 year track record,
313
00:14:36,242 --> 00:14:40,679
not just one clinical trial from 2020,
as Covid did.
314
00:14:41,113 --> 00:14:46,986
In, in certain age groups and, influenza has...
Twenty four times faster.
315
00:14:47,086 --> 00:14:50,089
it mutates 24 times faster than...
Bigfoot will tell you
316
00:14:50,222 --> 00:14:53,826
that it's got two very flimsy polymerases
which make that
317
00:14:53,859 --> 00:14:57,863
domain different
even within the same season.
318
00:14:58,063 --> 00:15:01,433
That's at such a higher, different,
and even with that,
319
00:15:01,433 --> 00:15:03,836
we don't hit the mark with the flu shot
each year.
320
00:15:03,836 --> 00:15:07,306
I'm not disparaging it,
but it's an entirely different animal.
321
00:15:07,539 --> 00:15:11,510
But I just want to give
because I, you know, I believe in sort of,
322
00:15:12,211 --> 00:15:13,779
seeing the best in everybody,
323
00:15:13,779 --> 00:15:17,316
the blind camp, that is,
the blind boosters in perpetuity
324
00:15:17,316 --> 00:15:21,754
without a clinical trial camp, they,
they would point to influenza
325
00:15:21,754 --> 00:15:24,189
and, you know, probably say, well,
it works there.
326
00:15:24,189 --> 00:15:26,725
So why don't we just adopt that?
327
00:15:26,725 --> 00:15:29,495
So, I'd like to give a shout out
to people with a different point of view.
328
00:15:29,495 --> 00:15:29,728
Yeah.
329
00:15:29,728 --> 00:15:30,696
And I think maybe to give them
330
00:15:30,696 --> 00:15:34,366
a little bit more like ...
A little bit more like why,
331
00:15:34,500 --> 00:15:36,402
I could see how they could have
adopted it.
332
00:15:36,402 --> 00:15:38,370
You know, the world was different in 2021.
333
00:15:38,370 --> 00:15:41,740
We had debuted a vaccine program,
and then we started to vaccinate people,
334
00:15:41,907 --> 00:15:43,342
and we were very optimistic.
335
00:15:43,342 --> 00:15:44,677
A lot of people were optimistic,
336
00:15:44,677 --> 00:15:47,680
that the vaccines
would completely halt transmission.
337
00:15:47,780 --> 00:15:50,916
You remember a lot of people got on TV
and said that they knew that to be true,
338
00:15:50,950 --> 00:15:52,651
which I think was a bridge too far.
339
00:15:52,651 --> 00:15:54,119
But a lot of people were optimistic.
340
00:15:54,119 --> 00:15:57,356
Then by the summer of 2021,
we were getting breakthrough infections.
341
00:15:57,356 --> 00:15:59,658
And by the fall of 2021,
we had Omicron variants
342
00:15:59,658 --> 00:16:02,861
and we had complete vaccine breakthrough,
at least for,
343
00:16:02,861 --> 00:16:05,864
symptomatic disease, perhaps
still protection for severe disease.
344
00:16:06,065 --> 00:16:09,401
So I can see why in that environment
somebody would say, boy,
345
00:16:09,435 --> 00:16:11,670
all we need is one more dose
or one more dose.
346
00:16:11,670 --> 00:16:14,773
Remember they used to say,
I told you, it's a three dose series.
347
00:16:14,840 --> 00:16:17,109
I told you it’s a four dose, right?
348
00:16:17,109 --> 00:16:17,743
I always told you its a five dose
349
00:16:17,743 --> 00:16:19,645
So I can understand why.
350
00:16:19,645 --> 00:16:21,580
Yeah, that ball could have started.
351
00:16:21,580 --> 00:16:23,082
That snowball could have started.
352
00:16:23,082 --> 00:16:26,485
But we have an obligation,
all of us here at FDA
353
00:16:26,485 --> 00:16:30,923
to follow the best available science
and to pick up questions,
354
00:16:31,223 --> 00:16:34,226
you know, as we get them.
What percent are ... Were you going to say something?
355
00:16:34,426 --> 00:16:37,997
What percent of the public
do you think, believes in the
356
00:16:37,997 --> 00:16:41,867
the blind boosters in perpetuity strategy
without any clinical
357
00:16:41,867 --> 00:16:43,769
trial evidence moving forward?
358
00:16:43,769 --> 00:16:46,372
I think it has to be lower
than the percent of the public
359
00:16:46,372 --> 00:16:49,074
that participates in such a strategy,
which is already low.
360
00:16:49,074 --> 00:16:50,809
You know, like you're pointing out,
one study
361
00:16:50,809 --> 00:16:54,179
showed 85% of health care workers
didn't get the Covid booster themselves.
362
00:16:54,680 --> 00:16:57,116
And among the people who got it,
some of those people want data, right?
363
00:16:57,116 --> 00:16:59,418
So yeah, a fraction of those people.
364
00:16:59,418 --> 00:17:03,589
So I mean, I think so in health care
might be 15% believe in that blind
365
00:17:03,655 --> 00:17:07,559
boosters in perpetuity,
without any further clinical trial.
366
00:17:07,559 --> 00:17:10,262
They want data like they're grateful
for us to having data.
367
00:17:10,262 --> 00:17:12,765
They just did it.
They just did it
368
00:17:12,765 --> 00:17:15,768
But the vast majority of doctors
I think are where we are.
369
00:17:16,035 --> 00:17:18,504
I also believe my belief is the media.
370
00:17:18,504 --> 00:17:19,238
How about media?
371
00:17:19,238 --> 00:17:20,406
How about media writers?
372
00:17:20,406 --> 00:17:23,709
What percent believe in the blind boosters.
Extremely high.
373
00:17:24,043 --> 00:17:27,513
And the reason I feel that is, you know,
they've been all throughout the pandemic,
374
00:17:27,513 --> 00:17:30,449
they're like, oh, what percent of you
still wipe down your packages?
375
00:17:30,449 --> 00:17:32,851
And among regular Americans,
it's very low.
376
00:17:32,851 --> 00:17:34,053
But among people who work at these
377
00:17:34,053 --> 00:17:37,856
Eastern and West Coast media outlets.
I saw that I saw that study.
378
00:17:37,890 --> 00:17:38,957
Yeah.
379
00:17:38,957 --> 00:17:41,827
You know, wipe down your packages
are still wearing N95 on the subway and,
380
00:17:41,827 --> 00:17:42,961
you know, all these kinds of things.
381
00:17:42,961 --> 00:17:46,832
We have to admit that the people
writing for these outlets,
382
00:17:46,832 --> 00:17:48,567
they don't represent the average American.
383
00:17:48,567 --> 00:17:50,969
They never have, at least
not in recent years.
384
00:17:50,969 --> 00:17:52,137
They've drifted further away.
385
00:17:52,137 --> 00:17:54,840
And that's led to problems
in all sorts of spaces,
386
00:17:54,840 --> 00:17:57,910
but especially in the medical science
space and especially on Covid 19 policy.
387
00:17:57,943 --> 00:18:00,946
I mean, I would also add, though,
just to everyone's credit, you know,
388
00:18:01,380 --> 00:18:03,382
the pandemic was this rare thing, right?
389
00:18:03,382 --> 00:18:05,617
It was a moment that people were scared,
didn't know
390
00:18:05,617 --> 00:18:07,186
a lot of uncertainty, to your point.
391
00:18:07,186 --> 00:18:09,088
And now there's new data and evidence.
392
00:18:09,088 --> 00:18:12,891
But at what point
over the last 4 or 5 years where we mass
393
00:18:13,158 --> 00:18:16,695
explaining and educating the American
public of what was changing, right.
394
00:18:16,695 --> 00:18:17,863
We're starting to do that now.
395
00:18:17,863 --> 00:18:21,366
And, you know, there's a sub community
that was really in tune
396
00:18:21,366 --> 00:18:24,837
with the science and were following
experts like the two of you along the way.
397
00:18:24,837 --> 00:18:29,041
But that wasn't what was being shared on
national media necessarily all the time.
398
00:18:29,041 --> 00:18:29,341
Right.
399
00:18:29,341 --> 00:18:32,444
So how could someone necessarily know
400
00:18:32,778 --> 00:18:35,514
that these things have changed
when we weren't really telling them?
401
00:18:35,514 --> 00:18:37,483
And now we are trying to explain that?
402
00:18:37,483 --> 00:18:41,286
I mean, I guess the elephant in the room
is that, of course, Marty and Jay Bhattacharya
403
00:18:41,320 --> 00:18:45,691
and many others who now hold
very important institutional positions.
404
00:18:45,991 --> 00:18:48,627
We're always on
these issues ahead of the curve
405
00:18:48,627 --> 00:18:51,597
and probably much more in sync
with the average American.
406
00:18:51,597 --> 00:18:54,333
And for that reason, I think
407
00:18:54,333 --> 00:18:57,569
the public you can see
on every social media platform I follow
408
00:18:57,603 --> 00:19:00,706
was really extremely pleased
with these selections.
409
00:19:00,706 --> 00:19:03,709
I mean, I was to I know them personally
to be excellent scientists and doctors,
410
00:19:03,709 --> 00:19:07,412
but also to be the kind of people
who are willing to, at times
411
00:19:07,513 --> 00:19:08,881
push against groupthink.
412
00:19:08,881 --> 00:19:10,749
I think it's a very admirable trait.
413
00:19:10,749 --> 00:19:12,551
And what we're doing here
is sort of bringing
414
00:19:12,551 --> 00:19:16,989
that philosophy to FDA, we're changing
the prior precedent a little bit, moving
415
00:19:16,989 --> 00:19:20,526
in this evidence based common sense
direction, bringing the U.S in line with,
416
00:19:20,826 --> 00:19:23,829
you know, the rest of the world
who always thought us to be an outlier.
417
00:19:23,962 --> 00:19:25,264
And I think that's what people want.
418
00:19:25,264 --> 00:19:26,732
And people are happy to have that.
419
00:19:26,732 --> 00:19:28,901
That's what my email inbox is telling me.
420
00:19:28,901 --> 00:19:31,803
Yeah, data is data is so key.
421
00:19:31,803 --> 00:19:34,373
And I think, you know,
we're talking a lot of hard data here.
422
00:19:34,373 --> 00:19:37,676
I also come from a world where we did
a lot of kind of qualitative data
423
00:19:37,676 --> 00:19:38,243
and getting,
424
00:19:38,243 --> 00:19:42,181
you know, input from surveys and,
you know, direct people from the market.
425
00:19:42,548 --> 00:19:45,617
As Marty knows, I used to run
a lot of CEO groups to understand.
426
00:19:45,617 --> 00:19:48,220
Yeah. You know, what are they thinking?
What are their priorities?
427
00:19:48,220 --> 00:19:50,822
And so that's a big part of our mission
here at the FDA.
428
00:19:50,822 --> 00:19:54,960
I've really, by the way, enjoyed
talking to CEOs of different companies.
429
00:19:55,327 --> 00:19:59,198
I, I've met with some trade associations
where they bring CEOs
430
00:19:59,665 --> 00:20:04,570
and like you were saying, like,
you know, Marty is good at explaining.
431
00:20:04,570 --> 00:20:06,905
So I think talking is is a skill set.
432
00:20:06,905 --> 00:20:10,108
You can learn the hard
skill set, which I have not mastered,
433
00:20:10,108 --> 00:20:11,643
but it's something I value highly.
434
00:20:11,643 --> 00:20:15,681
Is listening and evolving your position
and showing humility.
435
00:20:16,014 --> 00:20:16,982
And you know what?
436
00:20:16,982 --> 00:20:19,952
Maybe I was wrong about this
and saying that openly and publicly.
437
00:20:20,252 --> 00:20:24,690
I find just the oration part
is something that can be highly scripted.
438
00:20:25,057 --> 00:20:28,193
But listening is a hard job,
and it takes patience
439
00:20:28,193 --> 00:20:29,294
because you have to let somebody
440
00:20:29,294 --> 00:20:33,332
run around the barn with all their stories
and explanations and things
441
00:20:33,332 --> 00:20:36,635
that they are trying to, and everyone's
got something to push on the FDA.
442
00:20:36,635 --> 00:20:39,071
Everyone's got business
in front of the FDA.
443
00:20:39,071 --> 00:20:41,873
A lot of people think they have the cure
for whatever, and they really want
444
00:20:41,873 --> 00:20:46,778
the FDA to expedite, listen, actually
taking the time to listen and not sort of
445
00:20:46,778 --> 00:20:50,015
shutting down that idea, that's,
I think, the hardest skill set.
446
00:20:50,749 --> 00:20:52,851
But so do you have plans to?
447
00:20:52,851 --> 00:20:54,319
What are we going to do, Marty?
448
00:20:54,319 --> 00:20:59,591
Well, I, I, I was thrown this idea
by Sanjula earlier this morning about
449
00:20:59,791 --> 00:21:04,763
maybe we should think about some kind
of listening tour to meet with executives,
450
00:21:05,030 --> 00:21:07,933
from the industry, and,
451
00:21:07,933 --> 00:21:11,303
just do it on a sort of a big scale.
452
00:21:11,303 --> 00:21:15,774
Maybe West coast, East coast,
the West coast, my old stomping ground.
453
00:21:15,774 --> 00:21:17,175
Maybe middle of the country to.
454
00:21:17,175 --> 00:21:21,179
Yeah, the bicoastal elite is, is,
you know, sucking up all the bandwidth
455
00:21:21,179 --> 00:21:21,780
and science.
Leave that to the reporters.
456
00:21:23,682 --> 00:21:26,652
So, I mean, maybe we pick some cities.
457
00:21:26,652 --> 00:21:30,989
I think the San Francisco Bay area,
where you come from.
458
00:21:30,989 --> 00:21:32,491
A hub of innovation. I mean, a lot
of companies in that area,
459
00:21:32,491 --> 00:21:35,594
but and, and all the companies
of all stages and sizes,
460
00:21:35,594 --> 00:21:37,129
which I think is really important. Right?
461
00:21:37,129 --> 00:21:39,498
We tend to talk a lot
about just the established players,
462
00:21:39,498 --> 00:21:42,868
but there's a lot of innovation and,
you know, new entrants coming to market to
463
00:21:43,468 --> 00:21:48,373
and we'll go listen, get people's ideas,
feedback, what they're excited about.
464
00:21:48,940 --> 00:21:49,841
Think about those products
465
00:21:49,841 --> 00:21:53,712
and how we can expedite them
safely, you know, to market,
466
00:21:53,945 --> 00:21:59,251
maybe do like a town hall style
meeting with executives from leaders, R&D,
467
00:21:59,251 --> 00:22:03,689
CEOs of industry
next week is crazy for for me.
468
00:22:03,689 --> 00:22:06,625
But the following week,
maybe towards the end of the week.
469
00:22:06,625 --> 00:22:09,428
Okay. We hit San ...
I’ll clear it with my boss.
470
00:22:10,762 --> 00:22:13,031
You're cleared
471
00:22:13,031 --> 00:22:16,034
the San Francisco Bay area,
you got to clear it with Bigfoot.
472
00:22:16,401 --> 00:22:17,803
Bigfoot. Is that okay with you?
473
00:22:17,803 --> 00:22:21,940
If we make a national tour,
National town hall listening tour with.
474
00:22:21,973 --> 00:22:24,976
Okay, Bigfoot's on board, and,
475
00:22:25,911 --> 00:22:28,914
so, San Francisco Bay area,
I think would be good.
476
00:22:29,481 --> 00:22:32,484
San Diego, lot of companies in San Diego.
477
00:22:32,584 --> 00:22:33,852
Boston.
478
00:22:33,852 --> 00:22:38,957
Boston be great. How about Texas?
Dallas, I think I think Dallas and Houston.
479
00:22:38,957 --> 00:22:41,993
New York maybe?
New York would be good. Yeah.
480
00:22:42,194 --> 00:22:44,696
Atlanta.
481
00:22:44,696 --> 00:22:46,531
Yeah, we should do some.
482
00:22:46,531 --> 00:22:48,600
Maybe here, do 1 or 2 here.
483
00:22:48,600 --> 00:22:52,404
I mean, at some point, we got to work,
so we can't just be, doing town
484
00:22:52,404 --> 00:22:53,171
halls all the time.
485
00:22:53,171 --> 00:22:56,274
But, it'd be good to get all these themes
and see if there any common
486
00:22:56,274 --> 00:23:00,278
themes and sentiments across all these
different conversations
487
00:23:00,278 --> 00:23:03,548
And just ask what do you think the FDA should be doing
that it's not doing right.
488
00:23:04,383 --> 00:23:09,254
I mean, I love great ideas
and sometimes people attribute
489
00:23:09,254 --> 00:23:12,924
the ideas to me and I say, no, it they
these are ideas of the scientists here.
490
00:23:12,924 --> 00:23:16,695
When we get them alone
without their boss and say,
491
00:23:16,695 --> 00:23:21,233
what have you always wanted to do here
that you've never been able to do?
492
00:23:21,767 --> 00:23:22,834
And they talk.
493
00:23:22,834 --> 00:23:25,871
I mean, they will start talking
if they have the confidence
494
00:23:26,138 --> 00:23:30,642
of anonymity and.
And will act upon their suggestions
495
00:23:30,642 --> 00:23:34,012
if it's feasible and practical and make sense.
They can help implement
496
00:23:34,012 --> 00:23:37,015
these ideas. There’s some big ideas
in the pipeline.
497
00:23:37,082 --> 00:23:39,284
Big ideas coming down.
498
00:23:39,284 --> 00:23:41,653
Because I know you get bombarded
with requests to meet
499
00:23:41,653 --> 00:23:43,722
with all these different companies
all the time.
500
00:23:43,722 --> 00:23:46,992
You don't have, you can't spend
all your day just doing that.
501
00:23:46,992 --> 00:23:49,995
It's hard because I want to
and I love meeting people.
502
00:23:50,195 --> 00:23:52,597
So this is a good way
to bring a bigger group together
503
00:23:52,597 --> 00:23:55,600
and open it up to anyone who wants to,
to share those ideas.
504
00:23:55,934 --> 00:23:57,869
Yeah,
I think people have come into this job
505
00:23:57,869 --> 00:24:01,773
and this is not a criticism of anyone, but
I think it's easy to come into this job
506
00:24:02,174 --> 00:24:04,910
and meet
with all these external stakeholders.
507
00:24:04,910 --> 00:24:08,747
But I like meeting
with both external stakeholders
508
00:24:08,747 --> 00:24:13,819
and the scientists here, getting them,
you know, one on one and having them
509
00:24:14,252 --> 00:24:19,558
explain what can we do big, meaningful
common sense that bridges our two
510
00:24:19,891 --> 00:24:24,496
giant themes and that is gold
standard science and common sense both.
511
00:24:24,863 --> 00:24:24,963
Yeah.
512
00:24:24,963 --> 00:24:25,330
I'm curious,
513
00:24:25,330 --> 00:24:28,333
since you started the job, what's been
the most surprising thing for you
514
00:24:28,733 --> 00:24:30,001
about this job?
515
00:24:30,001 --> 00:24:34,806
I mean, I would say,
I'm I'd say a couple things.
516
00:24:34,806 --> 00:24:39,277
I would say the incredible expertise
and ideas that live here within the FDA,
517
00:24:39,644 --> 00:24:43,915
to how hard
it has been to post things on Twitter.
518
00:24:45,951 --> 00:24:49,020
I mean, clearance process, just,
you know, yeah, I don't
519
00:24:49,120 --> 00:24:52,324
I even getting my log in with
took like a month or something.
520
00:24:52,791 --> 00:24:55,360
He says you're sharing
a lot of your own communication,
521
00:24:55,360 --> 00:24:59,030
which I think is also a new precedent, right?
522
00:24:59,030 --> 00:25:02,033
These kind of videos, and we did
the one we did was live in a way,
523
00:25:02,167 --> 00:25:06,905
the virtue of live is that no attorney
can go and redact what you say.
524
00:25:07,172 --> 00:25:12,177
By the way, I did invite, a couple
of reporters who had asked for interviews.
525
00:25:12,177 --> 00:25:15,313
I invited them to do the interview,
526
00:25:15,780 --> 00:25:18,617
right here, live streaming,
live stream on our cameras.
527
00:25:18,617 --> 00:25:21,887
And, two of them. And they both declined.
528
00:25:22,153 --> 00:25:22,721
Really?
529
00:25:22,721 --> 00:25:25,991
Yeah,
I don't know, but one of them did say
530
00:25:25,991 --> 00:25:29,728
if they could come
and watch the the, conversation.
531
00:25:29,728 --> 00:25:34,633
I don't want to call it a podcast
and then have a one on one, interview.
532
00:25:35,734 --> 00:25:37,669
Not with cameras afterwards.
533
00:25:37,669 --> 00:25:38,637
Clarity.
534
00:25:38,637 --> 00:25:39,437
Well. Yeah.
535
00:25:39,437 --> 00:25:41,640
I mean, of course
536
00:25:41,640 --> 00:25:43,742
I want to say
this is my push to the reporters.
537
00:25:43,742 --> 00:25:47,612
You know, if you cover regulatory policy,
if you cover the FDA,
538
00:25:47,612 --> 00:25:50,715
and if you have covered all our major
decisions, including a decision this week.
539
00:25:51,049 --> 00:25:51,516
Come here.
540
00:25:51,516 --> 00:25:54,252
Pull up a chair,
ask the questions, live stream it.
541
00:25:54,252 --> 00:25:56,321
I think that's good
for the American people.
542
00:25:56,321 --> 00:25:57,489
We won’t know your questions.
543
00:25:57,489 --> 00:26:00,458
You know,
we don't even know each other's questions.
544
00:26:00,458 --> 00:26:01,860
545
00:26:01,860 --> 00:26:04,563
We don't have time to prepare for this. But
it will be really good.
546
00:26:04,563 --> 00:26:05,897
Ask the question
547
00:26:05,897 --> 00:26:08,833
the exactly what you're thinking
about this policy, and we'll answer it off
548
00:26:08,833 --> 00:26:09,568
the cuff.
549
00:26:09,568 --> 00:26:14,306
And I do think the absolute raw video feed
is what people want.
550
00:26:14,639 --> 00:26:17,442
I think you see that across
all social media platforms,
551
00:26:17,442 --> 00:26:20,779
you see people creating three hour
podcast discussions with people
552
00:26:20,779 --> 00:26:23,815
listening to 3 to 4 hours
where there are no edits.
553
00:26:24,015 --> 00:26:27,986
I think the editing is a problem because
it's selective editing, selective quotes.
554
00:26:28,286 --> 00:26:29,788
They frame it a certain way.
555
00:26:29,788 --> 00:26:31,323
It's supposed to be neutral,
556
00:26:31,323 --> 00:26:33,391
but it's really it's
sort of the opinions of the author.
557
00:26:33,391 --> 00:26:36,461
And if you follow the same reporter,
you can see some have some opinions,
558
00:26:36,461 --> 00:26:39,030
others have other opinions.
That’s why I think this is the fairest forum.
559
00:26:39,030 --> 00:26:40,632
Pull up a chair.
560
00:26:40,632 --> 00:26:42,267
Yeah.
Not even the opinions of the authors.
561
00:26:42,267 --> 00:26:46,338
Sometimes I know great reporters
who submit things, and I'll say,
562
00:26:46,338 --> 00:26:49,341
that's kind of a funny,
you know, headline that, you know.
563
00:26:49,474 --> 00:26:49,774
Yeah.
564
00:26:49,774 --> 00:26:52,711
That was on your piece,
which was a good piece.
565
00:26:52,711 --> 00:26:56,581
And it's it's by the
by the higher ups in corporate media.
566
00:26:56,915 --> 00:27:00,919
So, no the reporters are great. They’re helping
getting the message out there.
567
00:27:00,919 --> 00:27:01,820
We love them.
568
00:27:01,820 --> 00:27:03,188
I believe in love thy neighbor.
569
00:27:03,188 --> 00:27:07,792
And so they're doing a good job
and getting in communicating.
570
00:27:07,993 --> 00:27:10,328
What's happening at the FDA in general.
571
00:27:10,328 --> 00:27:15,300
Of course, you know, there's,
there's it's not a homogeneous group, but,
572
00:27:15,300 --> 00:27:19,738
yeah, I think the more conversations
the better and the more dialog,
573
00:27:19,738 --> 00:27:22,741
the better, and the more
we can be transparent and open
574
00:27:22,741 --> 00:27:25,877
and just run this unedited, the better,
the better.
575
00:27:25,877 --> 00:27:29,414
Of course, the downside of an unedited,
conversation on video
576
00:27:29,881 --> 00:27:32,717
is going to be boring parts,
and we're going to trip up a little bit,
577
00:27:32,717 --> 00:27:35,453
but you know that I think it's better
to just put it all out there.
578
00:27:35,453 --> 00:27:37,088
So we interrupted you.
579
00:27:37,088 --> 00:27:41,926
So you said, the people here were.
Surprised you
580
00:27:41,926 --> 00:27:45,130
you posting on on X.
Being so difficult.
581
00:27:45,230 --> 00:27:45,997
Yeah. Twitter account.
582
00:27:45,997 --> 00:27:48,633
You're not you're not going
to let me out of this question.
583
00:27:50,168 --> 00:27:53,038
No.
I mean, there's a lot of things I think that.
584
00:27:53,038 --> 00:27:53,204
Yeah.
585
00:27:53,204 --> 00:27:57,942
One thing that surprised me
is how you can actually do stuff
586
00:27:58,243 --> 00:28:03,181
I anticipated just this calcified
bureaucracy where to do anything.
587
00:28:03,181 --> 00:28:06,017
You have to go through this
giant rulemaking process.
588
00:28:06,017 --> 00:28:06,951
And there's a statute
589
00:28:06,951 --> 00:28:10,555
for everything that has some clause
that somebody is going to interpret
590
00:28:10,722 --> 00:28:15,060
to say, you can't do this, but,
you can actually do big stuff.
591
00:28:15,060 --> 00:28:20,532
And we are seeing so many, geniuses say
they want to come work at the FDA.
592
00:28:20,699 --> 00:28:22,233
And that's always been the case.
593
00:28:22,233 --> 00:28:26,538
People have always wanted to come and work
here, but, I have now
594
00:28:26,538 --> 00:28:28,306
I'm seeing it, from the front lines.
595
00:28:28,306 --> 00:28:30,709
People coming
and they're talking to folks.
596
00:28:30,709 --> 00:28:33,044
And the word is getting to me
that, you know,
597
00:28:33,044 --> 00:28:37,415
there's this amazing person and scientist
and academic and person with experience
598
00:28:37,415 --> 00:28:40,985
in every area of health care
that wants to come here.
599
00:28:40,985 --> 00:28:42,954
I mean, you're both examples of that.
600
00:28:42,954 --> 00:28:47,459
And we've got a diverse group of people
with, incredible backgrounds
601
00:28:47,459 --> 00:28:51,262
we're going to put together
a couple dream teams that will be,
602
00:28:51,796 --> 00:28:54,933
kind of a Swat team
to work on very specific issues.
603
00:28:55,300 --> 00:28:58,636
And,
we are hiring like the FDA is hiring.
604
00:28:58,636 --> 00:29:01,473
We're not doing a massive reorg
at this point.
605
00:29:01,473 --> 00:29:03,842
We are hiring scientific reviewers.
606
00:29:03,842 --> 00:29:08,613
We're hiring scientists
that can help us, achieve our goals
607
00:29:08,613 --> 00:29:12,717
of delivering more cures and meaningful
treatments for the American public
608
00:29:12,851 --> 00:29:14,719
and healthier food for children.
609
00:29:14,719 --> 00:29:16,955
And so that is going extremely well.
610
00:29:16,955 --> 00:29:21,659
We are going to be talking about talc,
at some time, very soon.
611
00:29:21,659 --> 00:29:24,662
Amazing topic.
I've learned a lot about it.
612
00:29:24,929 --> 00:29:27,899
But we're just going to keep going,
just as we did with the petroleum
613
00:29:27,899 --> 00:29:31,870
based food dye removal,
with all of these initiatives.
614
00:29:31,870 --> 00:29:33,805
And I think it's an exciting time.
615
00:29:33,805 --> 00:29:35,840
So exciting.
Cool.
616
00:29:35,840 --> 00:29:38,143
Well, thank you,
everybody. Good to see you.
617
00:29:38,143 --> 00:29:41,212
And we'll have more of these conversations
if you like them.
618
00:29:41,212 --> 00:29:42,180
Hopefully you do.
619
00:29:42,180 --> 00:29:45,950
So far the feedback has been good
and we just got to keep it tight
620
00:29:46,084 --> 00:29:48,186
so we can go right back to the office
to get work done.
621
00:29:48,186 --> 00:29:51,022
This has been playing a little bit here,
but work at the same time.
622
00:29:51,022 --> 00:29:51,256
Work.
623
00:29:51,256 --> 00:29:53,758
You were just in my office this morning
I'm like, why don't we just
624
00:29:53,758 --> 00:29:55,827
why don't we just walk over
and have this conversation
625
00:29:55,827 --> 00:29:59,030
in this conversation without, you know.
I have to walk all the way down from there.
626
00:29:59,030 --> 00:30:01,166
So I got to come forward.
Yeah. Get my steps.
627
00:30:01,166 --> 00:30:02,634
But you get the cafeteria.
628
00:30:02,634 --> 00:30:05,436
And on Tuesdays,
the farmers market on your way.
629
00:30:05,436 --> 00:30:06,504
So. Great.
630
00:30:06,504 --> 00:30:08,840
Yeah. Good to see you.
All right. Good to see you guys.