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Marty McCary, commissioner of the FDA.
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Welcome to San Francisco.
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>> Great to be here, Dave. Good to be with
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you.
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>> Yeah, thanks. It's JP Morgan Healthcare
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Conference this week in San Francisco.
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Considered, I think, probably the
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biggest most important biotech
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conference globally. Very important
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week. So, you're visiting this week for
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the conference.
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>> Yeah. 120,000 people, great
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conversations. You hear from everybody.
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Just not enough time to meet with
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everybody you want to meet with, but
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it's a great time.
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>> Well, thanks for sitting down with me.
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You and I have gotten to know each other
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a little bit over the last year or so
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>> and I'm really excited uh to hear a
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little bit about how things are going.
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It's been almost a year since you've
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been in the role. I think maybe for our
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audience you could share a little bit
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about how you got this role. How did you
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get involved with this administration?
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How did you get connected with them? And
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maybe we can go all the way back to your
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very outspoken views uh during the COVID
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pandemic and maybe how that brought
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attention to you and your philosophies
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that that drove this role.
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>> Yeah. So my um interest in academia, I
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um went to graduate school for public
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health and served on the faculty of the
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Johns Hopkins School of Public Health as
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I also had a clinical practice in GI and
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cancer surgery at Johns Hopkins. And my
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interest was always in the root causes
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of our healthcare system problems from
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quality, transparency, and price. And in
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the work on price, uh, I led sort of a
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national effort to try to get more price
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transparency of hospital prices. I wrote
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a book on it that did very well. It took
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me to the White House where they had
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read the book, invited me in, and in
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that first Trump administration, we had
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a lot of great conversations and then
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they implemented the idea and I was so
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impressed. This makes sense. You know,
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we want common sense ideas. And so we
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got the hospital price transparency
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executive order signed by the president.
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That's where I developed some of the
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relationships and got to know the folks.
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And then when uh President Trump got
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reelected, he gave me a call days after
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the election and I was very honored to
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be offered this role. So, it's been
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awesome. Uh co, you mentioned CO, it was
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a crazy time. I mean, the sort of
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sociology of medical dogma is a
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fascinating historical thing and we
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still suffer from it. paternalism, the
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sort of suppressing ideas that are not
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the legacy ideas, the sort of
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sacrificing the basic principles of
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science to question everything to have
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no sacred cows. And you saw the worst of
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that bad behavior during co cloth masks
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on toddlers for 3 years,
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vaccine mandates for young college
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students, recommending COVID boosters
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with such absolutism and young healthy
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children. you the um ignoring natural
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immunity. One of the most uh
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scientifically dishonest things a
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scientist could possibly say about the
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with the virus and the and the immunity
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and um shutting kids out of school for
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nearly two years which I fought tooth
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and nail along with Jay Bachari and
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others starting in the fall of 2020. We
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initially we were okay just doing stuff
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while we didn't understand it but once
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the data emerged we made a strong case
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to reopen the schools and to some degree
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I feel like we lost that battle but
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people now see that the data has caught
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up with public health officials and so
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I'm proud to be in office now to be a
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part of an effort to rebuild public
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trust in our health institutions and you
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must be having a lot of conflict then
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because you really are fundamentally
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trying to rewrite the way these
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institutions operate have operated and
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in some sense you are degrading the
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success and the career and the authority
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that some have vested themselves over
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time in those roles. How has that been
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and and what's the push back been like
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as you've kind of gone through this
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exercise?
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>> So I meet with folks at the FDA and if
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you meet with them with their bosses and
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everybody in the room to get a briefing
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on a topic then they give you one
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glowing story. But if you meet with one
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individual scientific reviewer and give
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them the safety of anonymity and say
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look I want to hear how is it going on
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the ground or what big ideas do you have
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that you've always wanted to do but not
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been able to do four out of five people
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or sometimes more will will not not
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really give you anything interesting but
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then somebody will say you know it makes
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no sense that we do it this way and we
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could do it better and we could do it
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this way something they they wouldn't
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feel comfortable offering if their
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supervisor were in the room. And so
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we've been running with these ideas. We
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have announced 42 major reforms in my 10
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months in office at the FDA
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and it it has challenged the status quo
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of doing things. But we have to I mean
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it why does it take 10 to 12 years for a
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new drug to come to market? We've become
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so lukewarm and passive accepting that
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horrible uh timeline that that has just
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become the status quo. We've got to
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challenge these deeply held assumptions.
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And we're doing it. We are doing it with
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new programs, new priority reviews, new
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pilots, new forms of transparency. We
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made our our rejection letters public so
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that if the FDA does not approve a drug,
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the public deserves to know why. And it
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creates accountability.
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>> And that was not the case before. They
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talked about it for 30 years and we got
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it done. They talked about banning one
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food diet for 35 years. Within weeks of
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coming into office, we took action to
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remove all nine artificial petroleum
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based diet. So, we're getting stuff
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done. We're not afraid to move fast. And
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in that role, some people have left
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the FDA and then they've been outspoken
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critics of yourself. Maybe you can
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respond to some of the criticisms that
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it's chaotic, that there's a lot of
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turmoil. I've worked at many startups. I
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know that when you move fast, things
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feel or they may feel too busy or they
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may feel like there's too much going on.
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It's overwhelming at times, but at the
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end of the day, progress is what
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matters. Maybe you could just comment on
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some of the reports made by employees
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that have quit the FDA, left and and and
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provided some comments on how things are
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going.
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>> There were 2,000 HR people at the FDA
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just before I got there. There were
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1,500
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IT people.
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And so, for a staff of how many total?
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>> 20,000 employees just before I got
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there. And so there was a goal to say,
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hey, we're going to go back to 2019
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staffing levels and the cuts are not
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going to be to scientists or reviewers.
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No scientific reviewer was laid off. But
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there were significant consolidations in
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HR, procurement, IT, and the duplicative
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services that were out there. Now,
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anytime you do something in government,
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you you take headline risk, but we felt
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it was the right thing to do. And so I
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came in right after that uh massive sort
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of change. And since then we've had a
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great culture. We've had more teamwork.
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We have new leaders. And they believe in
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this new vision. The number one priority
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of the commissioner that preceded me, he
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said, was to fight misinformation.
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>> Well, my number one priority is not to
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censor Americans. It's to deliver more
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cures and meaningful treatments faster
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to the American public and healthier
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food for children. And I think every
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employee at the FDA knows that mission.
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We have incredible teamwork. Um our
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turnover rate is at the baseline 5 to 7%
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that has been there for the last 10
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years at the agency. So there's no
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exodus, there's no mass uh departures.
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We are actually hiring 1,50 new
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scientists because we have very
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ambitious goals on our new pathways.
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accelerated type pathways. And so we're
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um building up capacity to have a whole
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new line of pathways so that we can
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deliver faster for the American people.
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>> Great. Well, look, let's start with a
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framing. The framing is the US verse
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China. I want to read this report that
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came from the Congressional National
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Security Commission on Emerging
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Biotechnology. We're here at a at a
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biotech conference. So, I figured we
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could start here because everyone's
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talking about China and the race against
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China. The US, according to this
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commission, has a three-year window to
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act to keep up with Chinese innovation
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and the speed in biotech.
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In 2022, Chinese companies were just 5%
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of licensing deals. 2025, 42%.
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And recently, one of the biggest
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licensing deals ever was 3S Bio 1.25
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billion up front with a $6 billion total
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with Fizer. China had 10 years ago only
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50% of published scientific papers to
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the US. Today they're 50% more than the
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US. So I just want to walk through your
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view on US biioarma
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innovation as it relates to China. Is
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there a race and if so what are the
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priorities for the administration in
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helping American biotech industry remain
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competitive?
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>> There is a race and when we came to
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office we were losing that race. We were
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behind. we were getting clocked by
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China, by Australia and other countries
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that were doing things more efficiently
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with less red tape and um we made it a
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massive priority to say we need to uh
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retain our number one position in life
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sciences and biomedical research and
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we've got to think innovatively so we
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can come up with some protectionist
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strategies but ultimately what we need
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to do is be more competitive with what's
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going on with phase 1's and INDs
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overseas.
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So that means we need to rethink our
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entire phase one uh process. We have to
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convene hospitals uh who are um so part
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of the problem is outside of the walls
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of the FDA. When hospitals have IRBs,
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that is the institutional review review
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boards that approve research that meet
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monthly and you know at at Johns Hopkins
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I had a study took a year and a half to
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go through the IRB. It was a survey.
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What are we worried about? It was a
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survey. It was a nutrition survey and at
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the end of a year and a half it was not
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approved.
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That kind of stuff is intolerable when
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we're competing with uh China where
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they're doing phase ones in 4 weeks with
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uh Australia that's doing phase ones in
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6 weeks. And so we need to uh have more
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centralized IRBs and we need to
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streamline the hospital contracting
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because right now if you want to do a
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trial each hospital wants to negotiate
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their margin of what they want and and
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sure they have to customize the contract
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because every study is different has
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different requirements and resources
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that are needed. But you go to Australia
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and they say sure sign here on the
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dotted line you have access to these 14
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hospitals or so. And so we have got to
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have more centralized contracting and a
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centralized IRB in order to compete.
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Those are big priorities. And we also
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have to reduce the red tape and
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regulation on our own IND's phase ones.
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And the entire process, you know, when
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we came in, it took 60 days for the FDA
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just to tell you whether or not they
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were going to consider a supplemental
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application. I mean, that kind of stuff
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is intolerable in the modern world. It
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took and you know some often still takes
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60 days just for the FDA to tell you
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that your application is complete. We're
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going to get that down to one day. We're
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going to use AI. So we've got to
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modernize the agency and be more
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competitive, not just talk about
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protectionist strategies. As you think
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about those work streams in improving
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the efficiency, turnaround time, how
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much can you do this on your own versus
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how much do you need Congress to act to
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pass legislation to support those
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changes? And are there priorities that
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you're working with Congress on to try
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and accelerate drug approval timelines
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that are necessary?
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>> So, right now we have user fees, which
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means if you submit an application,
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there's a fee associated with it because
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there's an unknown number of
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applications each year. So, it it's a
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system that's been around for a while.
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And so, uh, I'd like to see those user
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fees much higher if your phase one is
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done overseas. And if it's done in the
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United States, it's going to be a lower
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user fee. That's what I'd like to see.
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It's an America first policy. I'd love
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Congress to do a bunch of stuff, but
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we're not going to wait for them.
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Congress is slow. We're moving
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incredibly fast. You know, our number
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one goal was to make sure that the
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morale was good, the culture is good,
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and the and the trains are running on
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time, coming in right after the
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restructuring. I'm proud to report this
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year in 2025, this past year, we hit
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100% of our user feed target dates, that
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is the trains were all running on time,
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that every accept or reject decision by
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the FDA, was consistent with the accept
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or reject decision by the primary review
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team. That is, we're not doing secret
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deals. We're not messing with things. We
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are standing by our scientists. And last
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month we had a record number of drugs
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approved by our center for biologic cell
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and gene therapies and other nine drugs.
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And so we want to keep going hard and
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strong and innovate. But the first goal
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in the first nine months was to make
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sure the trains are running on time and
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that we are strong. And I'm happy to
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report the FDA is strong and is going to
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continue to be strong. And going back to
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this point about cutting down on
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timelines for phase 1 2 3 maybe you can
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just for the audience that may not work
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in this industry very briefly explain
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phase 1 2 3
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>> and then where we think there's the
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biggest kind of uh call it excess
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regulatory burden that's causing these
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extended timelines on drug approvals
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just just to kind of frame it up a
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little bit.
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>> Sure. So there's an something called the
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IND investigational new drug
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registration process. That's step one.
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Most of those are actually filed by
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academics and I think people forget that
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we still have a lot of great innovation
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in our academic spaces. It's not just
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the pharma labs. Uh then you uh try a
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drug in healthy subjects. That's called
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a phase one trial. Typically a small
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number, a handful. And then you give the
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drug to subjects with the condition and
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that's a phase two. It's a limited
00:14:06
study. And then phase three is a large
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randomized control trial. We call it the
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pivotal trial. We announced just last
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month that we are going to go from a
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baseline default requirement of two
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pivotal trials for a drug to one pivotal
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trial for a drug. It's just math. You
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can achieve the same statistical power
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if you design one good clinical trial
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properly with a good control group. Uh
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and so that by the way that saves like a
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hundred million to $300 million for some
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companies. Shortens the time. We're
00:14:36
reducing animal testing. That's the
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preend or prephase one work. that is how
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does it work in animals? We are
00:14:44
eliminating a lot of animal testing
00:14:45
requirements. We have a roadmap. You no
00:14:48
longer officially have to submit
00:14:50
chimpanzeee studies for monoconal
00:14:52
antibodies. That was announced two
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months ago. We said um so typically 144
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chimpanzees are used for a monoconal
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antibbody. By the way, it's it's
00:15:04
>> you're making me sick because this has
00:15:05
always been from my point of view one of
00:15:07
the most troubling bioethical concerns
00:15:09
I've had about the the industry because
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you don't get a lot of statistical power
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or benefit from doing this and it's just
00:15:16
awful that we do it. But
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>> you you actually get misleading
00:15:18
information sometimes. Some say aspirin
00:15:20
would not have been approved today if we
00:15:22
had the old animal testing requirements
00:15:24
to species because drugs that are uh
00:15:27
have safety concerns in animals may not
00:15:29
have safety concerns in humans. So we
00:15:31
may miss out on cures and vice versa.
00:15:34
90% of drugs that pass animal studies do
00:15:37
not pass safety and efficacy in humans.
00:15:39
So what are we doing? We have
00:15:40
computational modeling now. Computer can
00:15:43
look at a drug and actually make better
00:15:45
predict predictions and we have
00:15:46
something called organ on a chip
00:15:48
technology where you grow say the liver
00:15:49
cells or heart cells in a lab administer
00:15:51
the drug and then look for any enzyme
00:15:53
leaks or disturbances. These are modern
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techniques. We've got to modernize the
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agency. It's a massive goal. So
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>> and they're doing it in China. They're
00:16:00
doing it in China. And
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>> if we don't, then we're also putting our
00:16:03
industry at risk.
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>> We've got to be more competitive, 100%.
00:16:06
And so what does this do? It compresses
00:16:07
the time for approval. It allows
00:16:11
R&D to be done at a lower price point,
00:16:14
translating into lower drug prices for
00:16:15
everyday Americans. More drugs can be
00:16:18
evaluated. I mean, I had one pharma
00:16:20
executive tell me, "Hey, I love you're
00:16:22
going from 2 to one pivotal trials. That
00:16:24
means we can run twice as many drugs
00:16:27
through large pivotal trials." That's
00:16:28
what we want. We want to see more. Look,
00:16:30
I'm coming in with a bi. We all have our
00:16:32
biases. I have a bias and it's just a
00:16:34
matter of recognizing your biases when
00:16:36
we talk about reforms. My bias is being
00:16:39
at the bedside breaking bad news to
00:16:42
people with incurable conditions or
00:16:44
being at the bedside in the ICU. And
00:16:47
when you do that, it has a profound
00:16:50
impact on your brain and your soul. and
00:16:53
you think about what can we possibly do
00:16:58
to give this individual some hope. And
00:17:00
so when I see a 10 to 12 year time
00:17:03
period of bringing a drug to market, I
00:17:05
think in the modern world it makes no
00:17:07
sense. Just think about the advances in
00:17:09
science and technology. So I'm committed
00:17:12
to that mission. And we've got a new
00:17:13
pilot program now to get decisions out
00:17:15
in weeks.
00:17:17
>> It's unheard of. It's unprecedented. Uh
00:17:20
we have the first uh medication we just
00:17:23
announced after 55 days. Um we we have a
00:17:26
lot to change in the workflow to get
00:17:29
that time frame down. But we have I
00:17:30
think 18 products that have vouchers for
00:17:33
this new pilot program. If you're going
00:17:35
to do something new, you have to pick
00:17:37
criteria.
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>> You can either do it randomly or you can
00:17:40
pick criteria. So the criteria we chose
00:17:43
are drugs in line with our national
00:17:45
priorities. a unmet public health need.
00:17:48
Say a a new amazing cure for cancer
00:17:50
where the tumor shrinks in front of your
00:17:52
eyes and you don't need surgery or
00:17:54
chemo. That's a real thing. That's I'm
00:17:56
actually giving you a real example. We
00:17:57
gave those companies a voucher. Um if
00:18:01
you're bringing manufacturing back to
00:18:03
the United States, that's a national
00:18:05
security issue. And if you are going to
00:18:08
make the drug affordable, that's an
00:18:10
access issue. And that's an a massive
00:18:12
priority for this president is lowering
00:18:14
drug prices. So, we have uh this pilot
00:18:17
underway and it's going extremely well.
00:18:19
>> So, the drug company gets a voucher if
00:18:21
they qualify under one of those three
00:18:23
criteria and that gives them a fast
00:18:24
track.
00:18:25
>> That's right.
00:18:25
>> Yeah. And when will we get a readout on
00:18:28
how that program's going and whether it
00:18:29
becomes standard?
00:18:31
>> So, in internally it's going great. I
00:18:33
mean, I've got employees at the FDA tell
00:18:35
me, gosh, I love this. It makes sense.
00:18:38
And the reason we haven't done it before
00:18:40
is that we farm out the application to a
00:18:43
dozen offices and everybody has until
00:18:45
the target date to get their final
00:18:48
reports in. Well, the target date is
00:18:50
about a year.
00:18:51
>> So if you are a expeditious scientist or
00:18:54
you have the ability to uh go do your
00:18:57
work expeditiously and in two weeks you
00:19:00
have your result. Well, it doesn't
00:19:03
matter because the farm talks person or
00:19:05
whoever else is another part of that has
00:19:07
until the day before. Guess when they're
00:19:08
going to submit it? The day before. So,
00:19:10
we are changing the incentives
00:19:12
internally, the bonus structure. We're
00:19:14
changing the alignment. We're changing
00:19:16
the culture. And our goal is to
00:19:18
streamline that process.
00:19:20
>> Going back to the computational point,
00:19:21
we are collecting more data, digitizing
00:19:23
that data on patients than ever before.
00:19:26
That data should generally be
00:19:28
accessible. Is there a world where we
00:19:31
can transition from phase one, phase
00:19:33
two, phase three trials into a phase
00:19:35
one, phase two slash3 by taking into
00:19:38
account all of this additional data?
00:19:40
Some people have talked about the idea
00:19:42
of using AI plus other health data
00:19:45
that's collected and allowing the phase
00:19:47
3 to kind of roll into phase 2 and
00:19:49
create a much more expedited
00:19:51
computationally assisted approval
00:19:53
process. Is that something that's on the
00:19:55
road map or is discussed?
00:19:57
>> Absolutely. There has been tinkering of
00:19:59
combining phase one and two, phase one,
00:20:02
two hybrid trials, phase two and three
00:20:05
hybrid trials, approving something with
00:20:07
sort of a preliminary approval after
00:20:09
phase two if the results are really
00:20:11
promising. And those are all steps in
00:20:13
the right direction, but I think of
00:20:14
something much bigger. Can we move to
00:20:17
continuous trials? Can we use basian uh
00:20:23
statistical evaluation which we
00:20:25
announced this week? We are now going to
00:20:27
allow basian statistics to be used. So
00:20:30
now you can if something works instead
00:20:32
of having a committee meet twice a year
00:20:34
to do a cut of the data and print it out
00:20:37
and everybody looks at it. I mean I was
00:20:39
literally on those committees.
00:20:41
Why can't we in real time with AI tools
00:20:45
figure out when there's a safety signal
00:20:47
or efficacy established and then call it
00:20:51
at that point allowing more people to
00:20:53
get the drug as soon as we know it
00:20:55
works. And is there more continuous
00:20:57
tracking that's also possible to look
00:20:59
for risks and issues that start to
00:21:01
emerge in certain populations? Because
00:21:03
this is something that it's almost like
00:21:04
the approval happens and then you find
00:21:06
out years later that well maybe there
00:21:08
was an issue that we should have caught
00:21:09
sooner. And if you move to a more
00:21:12
datadriven continuous observational
00:21:14
system, can you both have faster
00:21:16
approvals but also faster recognition of
00:21:18
safety concerns for specific population?
00:21:20
>> Yeah, I love the way you're thinking. So
00:21:21
we I want to see continuous trials with
00:21:24
endpoints in the cloud
00:21:25
>> so that the reviewers are looking on to
00:21:28
the endpoint. You don't do your freshman
00:21:30
year of college and then submit a giant
00:21:33
50,000page application to start your
00:21:35
sophomore year and then do your
00:21:37
sophomore year and start another 50 page
00:21:39
to start your but that's what we're
00:21:41
doing at the FDA. Now look, it had good
00:21:42
intentions, but we live in a modern
00:21:44
world. We're using computers now, not
00:21:46
stone tablets. And so we can run more
00:21:49
continuous trials. That's the goal. And
00:21:51
we can use basian statistics, which we
00:21:53
announced this week a a a big uh uh sort
00:21:57
of new milestone with that. And I want
00:22:01
to see um I want to see us continue to
00:22:04
have eyes on a drug after approval. So
00:22:08
approval is sort of a a point where we
00:22:11
say hey the world can use it with a fair
00:22:14
degree of confidence on the safety uh
00:22:17
efficac and efficacy tradeoff but
00:22:21
uh why did we learn 5 years after Vio
00:22:24
was approved that it may have killed
00:22:26
38,000 people well in the modern world
00:22:29
with big data we can have eyes on a drug
00:22:32
as it's being used in real time to call
00:22:36
out that safety signal. immediately and
00:22:38
let people know. It may be a subgroup of
00:22:40
people that are affected. There may be a
00:22:41
drug drug interaction. Um, you know, you
00:22:44
think about the opioid epidemic, 15
00:22:47
years of prescribing it, having no idea.
00:22:50
And I was I'm guilty. I was doing this.
00:22:52
I was prescribing it. My patients were
00:22:54
getting addicted, coming back for
00:22:55
refills. I thought it was kind of a
00:22:57
one-off thing. You know, a lot of people
00:22:59
come back, ask for refills. No, it was a
00:23:01
national pattern we should have
00:23:02
identified in big data. And so we're
00:23:04
going to do postmarket surveillance in a
00:23:07
way like we've never seen before using
00:23:09
big data. And if we get it right, if we
00:23:11
get it right and there's a big priority,
00:23:13
it can actually change the threshold of
00:23:16
approval because you know you're going
00:23:17
to have eyes on a drug immediately for
00:23:19
people in the general audience to
00:23:21
understand this begs the question and I
00:23:24
think people will bring this up as as a
00:23:26
critique of absolute safety. I always
00:23:29
talk about the example of you put the
00:23:32
Whimos or the autonomous cars on the
00:23:33
road, they uh cut down on uh fatalities
00:23:38
by 95%. But as soon as one person gets
00:23:41
killed by a Whimo, the media goes crazy
00:23:44
and says these autonomous cars are
00:23:45
killing people.
00:23:47
You know, and and and this this begs the
00:23:49
question about the the understanding of
00:23:52
safety and risk uh versus the benefit
00:23:55
that can occur. You know, I was sharing
00:23:57
with you about a family member who had
00:24:00
to wait a long time to get a certain
00:24:02
therapeutic and I was thinking about the
00:24:04
thousands of people that that died it in
00:24:07
that same period of time. Fortunately,
00:24:08
he was able to get the therapeutic, but
00:24:09
all the people that that died because
00:24:11
they couldn't get access to this drug.
00:24:14
How do we convey to the general
00:24:15
population the idea that speed matters
00:24:18
in saving lives and this question about
00:24:21
absolute safety and absolute risk around
00:24:24
drug approval? This is really important
00:24:26
when you talk about risk to a general
00:24:29
audience. How do you convey that second
00:24:30
order effect?
00:24:31
>> That's right. So safety is our number
00:24:33
one priority. We are to safeguard the
00:24:35
the public. But having 8 months of 144
00:24:41
chimpanzees go undergoing studies has
00:24:44
risks to the general public. You may be
00:24:46
holding back a curative medication for 8
00:24:49
months. Not identifying the efficacy in
00:24:52
a trial with basian statistics. um early
00:24:56
enough has risks because that extra lag
00:24:59
period is time when patients like the
00:25:02
patients that I treated at John's
00:25:03
Hopkins are told sorry we don't know of
00:25:06
anything out there so time delays that
00:25:10
are unnecessary have risks and I think
00:25:13
that is something we don't think about
00:25:15
in the FD you know enough at the FDA we
00:25:17
think oh we have this concern let's
00:25:19
sleep on it okay well you get a night to
00:25:21
sleep on it not 9 months
00:25:23
>> so I want to give a flip to this. The
00:25:25
right to try law gives patients access
00:25:27
to drugs that uh when they're in a
00:25:29
certain condition, they can access the
00:25:31
drug before it's gone through full
00:25:32
approvals. What's the current state of
00:25:34
right to try? Where do you view that
00:25:36
going? And does the threshold for right
00:25:39
to try change over time, giving patients
00:25:41
and their doctors more rights and more
00:25:44
access sooner or does the FDA still have
00:25:46
to hold firm? How do you think about
00:25:48
that over time?
00:25:48
>> So, I believe in both the letter and the
00:25:51
spirit of right to try. It's an amazing
00:25:53
achievement of U. President Trump in the
00:25:55
his first term and I have signed 100% of
00:26:00
right to try requests that come across
00:26:01
my desk. Of course, the companies have
00:26:03
to agree to make the medication
00:26:05
available, but it's a great program and
00:26:08
like we don't want people getting spun
00:26:10
up on snake oil that doesn't work,
00:26:12
that's cost $3 million where their
00:26:14
churches are doing GoFundMe campaigns
00:26:16
when we know a drug does not work. So,
00:26:19
we do have a responsibility and we do we
00:26:22
we have to be good stewards of the
00:26:23
Medicare program. They're using taxpayer
00:26:25
dollars to fund things. But if there's a
00:26:28
signal that something works and somebody
00:26:31
wants to try a drug, who are we to say
00:26:33
you can't? So, we look at safety, but
00:26:36
beyond safety, we are, you know, have to
00:26:39
be as flexible as possible with our uh
00:26:43
regulation. And we announced just this
00:26:44
week that we are getting rid of the some
00:26:47
of the regulatory requirements for cell
00:26:49
and gene therapy. Now those are used for
00:26:51
a lot of rare diseases, but we had
00:26:53
requirements uh what we call PPQ runs
00:26:56
for batches of um it's part of the
00:26:59
manufacturing requirements for cell and
00:27:01
gene therapies. We were holding them to
00:27:03
the same standards we were for say mass
00:27:05
manufacturing of a pill. Well, a cellar
00:27:07
gene therapy can be developed in a lab
00:27:09
at UCSF or Stanford. And are we going to
00:27:12
require that they use the same
00:27:14
manufacturing broad standards to do
00:27:17
multiple batches when you've got a
00:27:20
scientific platform that works, a vector
00:27:22
platform that works and you're basically
00:27:24
doing surgery on the human genome just
00:27:27
in different locations? So, we made that
00:27:29
announcement earlier this week.
00:27:31
>> So, let me just understand that one.
00:27:33
I've I've spent a little time in the
00:27:34
space. Does this mean that I will not
00:27:37
need to go through a GMP or good
00:27:38
manufacturing practice facility to bring
00:27:40
those therapeutics to a broader set of
00:27:42
patients? And does it also mean that
00:27:44
once I've got a system that works, I can
00:27:46
use it for different indications? And
00:27:48
maybe help understand a little bit about
00:27:49
where this goes because there's many
00:27:50
patients that today are looking at
00:27:53
papers on cell and gene therapies, early
00:27:55
data, and they're saying, "When can I
00:27:56
get access? I'm at risk." This matters a
00:27:59
lot to patients. and maybe you can help
00:28:01
contextualize how this translates into
00:28:03
speed and and access.
00:28:05
>> Yeah. So, the announcement that we made
00:28:06
on Sunday was that we're going to
00:28:09
customize the manufacturing requirements
00:28:12
to the drug and the population being
00:28:14
treated. So, there's a number of
00:28:15
flexibilities including the ones you
00:28:17
mentioned, but it's no longer going to
00:28:19
be this hard and fast. You have to do it
00:28:21
this way. For example, the three batch
00:28:24
runs that have been required, those
00:28:26
ingredients are expensive. I mean, those
00:28:27
ingredients could cost $100,000 for just
00:28:29
one ingredient. And so, we have to use
00:28:33
common sense. I mean, when you see
00:28:35
something uh perform, you know,
00:28:38
something magical to a kid with no help
00:28:41
right in front of your eyes, you've got
00:28:44
to say like, what are we doing getting
00:28:45
in the way? We just um had early in u
00:28:49
our time there, baby KJ go from go home
00:28:52
from the hospital, right? So this infant
00:28:54
got gene editing therapy. You can't do a
00:28:57
randomized trial on that. There's not
00:28:59
enough kids who have it. So we these
00:29:02
bespoke therapies. We created
00:29:04
essentially a novel pathway for them. Uh
00:29:07
Dr. Vani Prasad uh described it in the
00:29:09
New England Journal of Medicine. It's
00:29:11
called the plausible mechanism pathway
00:29:13
and it's basically combining gold
00:29:15
standard science with common sense.
00:29:17
>> Right. And what about for CARTT therapy?
00:29:19
So there's this blossoming class of
00:29:21
therapeutics in CARTT that's
00:29:23
historically been used exclusively for
00:29:25
oncology for cancer. Um increasing
00:29:28
discussion about using it for autoimmune
00:29:30
conditions. Does this help with the
00:29:32
CARTT therapy pathway and enabling
00:29:35
faster routes to market and more access
00:29:37
and lower cost?
00:29:38
>> It can. And by the way, CARTT is
00:29:40
amazing. Carti is amazing. I'm not here
00:29:42
to pro promote any one class of drugs
00:29:45
but I mean it the stuff that we have
00:29:47
seen um is mindboggling.
00:29:50
>> So yes
00:29:50
>> and just for folks to understand when
00:29:52
they take tea cells edit them and put
00:29:54
them back in the body and those tea
00:29:56
cells go after targets in the body and
00:29:58
destroy those targets and many blood
00:30:00
cancers uh are now seeing extraordinary
00:30:02
results with these CARTT therapies and
00:30:05
now they're going after autoimmune
00:30:06
conditions. But it definitely seems to
00:30:08
be that there there needs to be a faster
00:30:10
path to market, lower cost because the
00:30:12
pricing is half a million to a million
00:30:14
dollars still.
00:30:14
>> Yeah. It's amazing. We're essentially
00:30:16
activating your own immune cells to to
00:30:19
have a a very clear path and target
00:30:22
something in your body that needs to be
00:30:24
targeted. So it's now we did find um
00:30:28
that there was in the Biden
00:30:30
administration approval to have the
00:30:33
cells of Americans for CARTT therapy
00:30:36
shipped to China where the Chinese did
00:30:38
the gene editing and then ship back to
00:30:39
the United States to infuse in
00:30:41
Americans. When I found out about that,
00:30:42
we shut that thing down so fast. Yeah.
00:30:45
So, uh we have to do things carefully.
00:30:47
>> What else have you discovered since
00:30:48
you've been in the FDA that shocked
00:30:50
>> you? Just go on a side for a second. I'm
00:30:53
I'm curious to know what are the biggest
00:30:55
shocks that you've uncovered. I mean,
00:30:57
you've now been there for some time, you
00:30:59
mentioned before we sat down that you're
00:31:02
actively digitizing millions of files
00:31:05
>> that historically have not been
00:31:06
digitized, and I'm I'm assuming you can
00:31:08
now use AI and other tools to go read
00:31:10
through them very quickly. What's been
00:31:12
shocking to you?
00:31:13
>> Where do I start? I mean, somebody was
00:31:16
carrying a box from one building to
00:31:18
another building with uh with a um drug
00:31:22
file in it. And um it turns out that the
00:31:25
lawyers said they couldn't email the
00:31:27
information to the other center because,
00:31:30
you know, each center was like their own
00:31:32
secret government before we got there.
00:31:35
>> Each center of the FDA.
00:31:37
>> Each center of the FDA.
00:31:38
>> Same agency.
00:31:38
>> Yeah. Same agency. Seven centers. It was
00:31:40
like, you know, they had their own
00:31:42
boundaries and territories and, you
00:31:44
know, lawyers. They had their own
00:31:45
communication staff put out their own
00:31:47
releases, uh, their own press releases,
00:31:49
did their own legislative affairs with,
00:31:52
had scheduled their own hearings.
00:31:53
>> And the commissioner was out of the loop
00:31:55
sometimes. And so, we restructured the
00:31:57
entire agency. Now, we centralized those
00:32:00
services. But in the days of this sort
00:32:02
of siloed world of the agency, by the
00:32:04
way, it was a nightmare for uh
00:32:07
developers that had a drug device
00:32:08
combination. Um, right.
00:32:11
>> I mean, it was like gerrymandered lines
00:32:12
of what was included in one center
00:32:14
versus another center based on
00:32:16
infighting. And, uh, you know, people
00:32:18
had served long terms there. You know,
00:32:20
they'd serve terms like, uh, President
00:32:23
Mugab of Zimbabwe who'd been there, you
00:32:25
know, forever. These people just were
00:32:27
there forever, right? It was just their
00:32:29
way. And, uh, anytime there was an
00:32:32
opening in leadership, 19 times out of
00:32:34
20 it went to an internal candidate. So,
00:32:36
you didn't have a lot of fresh new
00:32:38
ideas. We have a lot of a lot of fresh
00:32:39
scientists coming in there. I mentioned
00:32:41
the 1,000 new scientists. We're we're on
00:32:43
boarding right now um 450 of them. 50 of
00:32:47
them already just started. But um I've
00:32:50
met a guy who
00:32:52
uh his job was to change the ink
00:32:54
cartridge on a fax machine on one fax
00:32:58
machine. Uh like healthc care has
00:33:01
single-handedly kept the fax industry
00:33:03
alive.
00:33:03
>> Wow.
00:33:04
>> Um the guy's job was the ink guy on the
00:33:06
fax machine. to swap out the
00:33:09
>> machine.
00:33:11
>> There's a lot of that. There's a lot of
00:33:12
that.
00:33:12
>> Well, let's shift over to food. Maybe
00:33:15
I'll just give you a moment to share
00:33:17
what you changed in the food pyramid in
00:33:18
the announcement last week. Why you made
00:33:21
those changes and why weren't they made
00:33:24
before?
00:33:27
Yeah. So, we have had decades of medical
00:33:31
dogma and corruption putting together
00:33:34
food pyramids that make no sense. people
00:33:36
can tell. I mean, the open secret was
00:33:38
that they make no sense. They're
00:33:40
scientifically inaccurate and they were
00:33:43
often times curated by the food industry
00:33:45
or the food industry's influence on
00:33:47
academia. Nutrition science may be one
00:33:50
of the most corrupted fields in all of
00:33:53
science. And it gave us the dogma that
00:33:57
we had to focus on saturated fat and
00:33:59
just eradicating natural healthy fats
00:34:02
from the US food supply. Ignoring that
00:34:05
you replace fats with healthy with
00:34:08
refined carbohydrates which are not
00:34:10
healthy. And we have this carbohydrate
00:34:14
heavy diet now for American children.
00:34:16
And guess what? 38% of kids have
00:34:18
pre-diabetes or diabetes. Is that a
00:34:21
surprise? The rise has paralleled the
00:34:24
shift from saturated fat or regular food
00:34:27
to pumping refined carbohydrates and
00:34:30
added sugar. 60 to 70% of the calories
00:34:33
of a child in America today are refined
00:34:35
carbohydrates.
00:34:37
No one has talked about it. It's been in
00:34:39
a blind spot as the medical
00:34:42
establishment has had this myopic focus
00:34:46
on the boogeyman of saturated fat. And
00:34:49
so we had a food pyramid that was
00:34:52
entirely backwards. And so we flipped it
00:34:55
upside down using good science talking
00:34:58
about a an previously ignored area of
00:35:02
nutrition. And that is the importance of
00:35:03
protein. We've been getting about half
00:35:06
the protein that we need. The protein
00:35:08
levels in the previous dietary guidance
00:35:10
was really just to prevent withering
00:35:12
away.
00:35:14
We want our American kids to thrive,
00:35:16
>> right? and and look at the status of
00:35:18
kids today.
00:35:20
Low in protein,
00:35:23
muscle wasting, weakness,
00:35:25
um underperforming in school, high in uh
00:35:28
refined carbohydrates and added sugar,
00:35:30
giving them that kind of uh sugar um
00:35:34
sort of coma, food coma after a refined
00:35:37
carbohydrate
00:35:39
uh breakfast. Again, we hit them hard in
00:35:41
the afternoon. They get very little or
00:35:43
no natural light exposure. They're told
00:35:46
to sit at a desk still for 7 hours a
00:35:48
day. They can't do it. And what do we
00:35:50
do? Tragically,
00:35:52
we have drugged our nation's kids at
00:35:54
scale. It's wrong. It needs to stop. We
00:35:56
have to reexamine the root causes. And
00:35:58
so, flipping this food pyramid upside
00:36:00
down, focusing on protein is the first
00:36:02
step. And so, I'm very proud of what we
00:36:04
were able to do. What have you uncovered
00:36:07
now that you've been inside the
00:36:08
organization and you can see paperwork
00:36:11
related to the legacy of how the old
00:36:13
food pyramid was constructed and
00:36:15
maintained for so long about the
00:36:17
motivations who was involved in setting
00:36:19
that food pyramid when you mentioned the
00:36:21
corruption of nutrition science. Help us
00:36:23
understand the root of that. So, I wrote
00:36:26
a book um just before coming into office
00:36:29
where I had a chance to do a deep dive
00:36:31
and do some investigative journalism, if
00:36:34
you will, to learn how this dogma of
00:36:38
what to eat got we got so wrong. And I
00:36:43
think it was a lot of group think just
00:36:45
like we saw with opioids are not
00:36:48
addictive. Medical establishment got
00:36:51
that wrong for 15 years.
00:36:54
Uh, young kids should avoid peanut
00:36:55
butter until they turn three. We got
00:36:57
that wrong for 16 years. Tragically
00:37:00
wrong. Igniting the modern-day peanut
00:37:03
allergy epidemic because peanut butter
00:37:05
exposure in infancy
00:37:08
reduces there's something called immune
00:37:10
tolerance, right? And it reduces the
00:37:12
risk of peanut allergies. We're the only
00:37:14
country in the world that has high rates
00:37:16
of peanut allergies along with UK and a
00:37:18
few other European countries that fell
00:37:21
for our dogma based recommendation to
00:37:23
avoid peanut butter till the kid turns
00:37:25
three. And so we got that 180 degrees
00:37:29
wrong. And so there are dogmas in the
00:37:32
medical field that take on a life of
00:37:34
their own and you're not allowed to
00:37:35
question them. And we saw a little bit
00:37:38
of it during COVID if you recognized
00:37:40
natural immunity and may not need to be
00:37:42
fired from your job because you have
00:37:44
circulating antibodies to COVID, but
00:37:46
they were just antibodies that the
00:37:49
government did not recognize.
00:37:51
This dogma can take on a life of its
00:37:53
own. And so we're trying to get back to
00:37:55
gold standard objective science. It is
00:37:57
crazy that the fundamental premise of
00:38:00
science is you ask a question and then
00:38:03
you test whether there's one answer or
00:38:06
another. And the idea that you can't ask
00:38:09
questions indicates that it's not
00:38:11
science from my point of view. All
00:38:13
standards should be challengeable. That
00:38:15
you should be able to ask the questions
00:38:16
and fundamentally if they they hold
00:38:19
truth or they hold ground then great.
00:38:21
Let's maintain them. And if they don't
00:38:24
we should be able to change. And then
00:38:26
they use the word science or
00:38:27
historically the word science has been
00:38:29
then used to justify not testing
00:38:30
something.
00:38:31
>> That's right.
00:38:31
>> It's it's crazy to me. What are the
00:38:33
roles that food companies have played?
00:38:35
What are the roles that folks that might
00:38:38
have an economic incentive in keeping
00:38:41
the food pyramid as it was played
00:38:44
historically in this? And is that
00:38:46
permanently changed at this point or is
00:38:48
it changed while this administration is
00:38:49
here and it's going to change again next
00:38:51
cycle? help us understand a little bit
00:38:53
about you know the the the role that
00:38:56
industry has in influencing some of this
00:38:59
regulatory process.
00:39:01
>> Well, I think the industry did what the
00:39:04
medical field told them to do and that
00:39:07
is to address the risk of mass
00:39:10
starvation and deal with food insecurity
00:39:13
and that calories in equals calories out
00:39:15
regardless of where those calories come
00:39:17
from. That was the dogma and sort of the
00:39:19
the mandate to the food industry. So um
00:39:22
they did what they were told to do and
00:39:25
so they moved to refined carbohydrates.
00:39:27
They stripped the grains of fiber to
00:39:29
mass-produce them. They would even chop
00:39:31
them up which made them increase your
00:39:34
glycemic index. That is it basically
00:39:37
function like sugar. So you have
00:39:40
cereals, breads, pastas functioning like
00:39:43
sugar. And so we ushered in a generation
00:39:47
of kids and you and I were the first
00:39:49
gener who were part of this the first
00:39:51
generation in human history with massive
00:39:53
insulin spikes daytoday in our normal
00:39:56
everyday life. We've never seen insulin
00:39:58
spikes to that degree. And of course
00:40:00
that drives something called insulin
00:40:02
resistance. That is the the organs in
00:40:05
your body that do important functions
00:40:07
are trying to block out all this extra
00:40:09
glucose. And so they kind of um uh
00:40:14
change the configuration of the insulin
00:40:15
receptor to just try to resist all this
00:40:18
sugar coming in. And it is at the root
00:40:21
of almost every chronic disease. Insulin
00:40:23
resistance, general body inflammation.
00:40:27
And we never talk about these things.
00:40:29
Never. So we talked about them front and
00:40:31
center in our new uh guidance. The types
00:40:34
of grains matter. It's not calories in
00:40:36
equals calories out. It's not you can
00:40:37
have this if you sit on the treadmill
00:40:39
for this amount of minutes. We've got to
00:40:42
talk about the soil that food comes from
00:40:45
and the farming techniques that animal
00:40:48
products come from and the cleanliness
00:40:51
and chemical-free waters that seafood
00:40:54
comes from and the importance of protein
00:40:56
and the value of whole grains and what
00:40:59
we call real food. And so the website is
00:41:01
realfood.gov. My only criticism is the
00:41:03
lack of vegetarian protein in the top of
00:41:05
the pyramid where as a vegetarian I eat
00:41:08
eggs and dairy. It could use a few more
00:41:10
nuts and beans up top, but you know,
00:41:12
I'll talk to Joe Gibbia about it.
00:41:13
>> It could. No, it could. I think the New
00:41:15
York Times had a conception about blue
00:41:17
the blueberries.
00:41:18
>> The blueberries.
00:41:19
>> I think it was uh uh disproportionately
00:41:24
uh disturbingly large
00:41:25
>> disturbingly large blueberries. That was
00:41:27
the criticism. Okay, that wasn't one
00:41:29
that bothered me. Let's talk about the
00:41:30
the adult population. I think 40 to 60%
00:41:33
depending on how you measure it are
00:41:34
obese clinically obese in this country
00:41:36
and these incretin mimedics GLP1 drugs
00:41:38
and others have really taken the market
00:41:41
by storm taken our population by storm.
00:41:42
So I realize that much of this is in
00:41:44
response to an obesity epidemic that
00:41:46
we're facing in this country. But it
00:41:48
turns out that these incretin mimedics
00:41:50
may actually have other systemic
00:41:52
benefits and they're now I think there's
00:41:54
60 indications that they're being tested
00:41:56
against including kidney neurological
00:42:00
cardiac. I mean there's there seems to
00:42:01
be a lot of benefit potentially in uh
00:42:04
using them for other disease
00:42:06
indications. Can you speak a little bit
00:42:07
about your view on where this market
00:42:10
where this class of therapeutics is
00:42:12
headed? Is this something that some
00:42:14
people have estimated or 60% of
00:42:15
Americans are going to be on? And if it
00:42:18
is the case, does that mean we failed
00:42:19
with our food system?
00:42:20
>> Well, first of all, we have failed with
00:42:22
our food system. Look at the fact that
00:42:24
40% of American kids have a chronic
00:42:27
disease.
00:42:28
Between the lines in the medical
00:42:30
textbooks in medical school was kind of
00:42:33
a blaming of children for not having the
00:42:36
discipline. And it's not a willpower
00:42:39
problem. This is highly addictive uh
00:42:42
chemicalized foods that are
00:42:44
ultrarocessed that are put in front of
00:42:46
kids and they want more and you you put
00:42:48
these vibrant colors in them from the
00:42:50
petroleum based dyes. And so this is
00:42:52
something adults have done to kids. And
00:42:54
so I think that we have failed. We've
00:42:57
given people the wrong information. The
00:43:00
calories in equals calories out, this
00:43:02
demonization of fat and all that stuff
00:43:03
we talked about. um GLP-1s are mimicking
00:43:07
a natural hormone in the body. And so
00:43:11
when you get a supplementation of that,
00:43:13
it's doing the job of increasing
00:43:15
satiety, slowing down GI motility, and
00:43:18
it has a profound impact on a number of
00:43:21
conditions because you are also reducing
00:43:25
insulin resistance and general body
00:43:27
inflammation. And so that's why we're
00:43:29
seeing so many other benefits. Plus, you
00:43:31
feel better. When you feel better,
00:43:33
you're going to have benefits you don't
00:43:34
even we haven't even appreciated yet
00:43:37
because there's an incredible value this
00:43:40
sort of positive thinking. We've seen it
00:43:41
in a breast in a lung cancer study from
00:43:45
Mass General. They randomize people to
00:43:48
palative support versus chemotherapy and
00:43:51
the palative support did better even
00:43:52
though chemo drug is is more effective
00:43:55
than standard of care. So, um, you see
00:43:58
this incredible value to sort of
00:44:00
positive thinking and maybe that's one
00:44:02
of the reasons we're seeing reductions
00:44:04
in addiction. Maybe we're, you know,
00:44:06
we're seeing cardiac benefits. So, we'll
00:44:08
see. I mean, we're, you know, as a
00:44:10
regulator, we're a referee and we want
00:44:12
to see products come to market quickly
00:44:15
and safely, but I think we're we're
00:44:17
we're at a pretty interesting time.
00:44:19
>> Yeah. Just to go back on the China point
00:44:21
because we did talk about
00:44:22
competitiveness with respect to speed,
00:44:24
but the other piece I wanted to address
00:44:26
was
00:44:27
>> uh funding of research. So that uh that
00:44:30
bioh technology council I mentioned
00:44:33
recommended a $15 billion kind of rushed
00:44:36
investment in in research. When I meet
00:44:38
with scientists, there's a view that the
00:44:41
Trump administration is anti-science, is
00:44:44
defunding a lot of research institutions
00:44:46
in the United States that are going to
00:44:48
save people's lives and develop amazing
00:44:50
cures. Why are they doing this? There's
00:44:53
this council that recommends that even
00:44:54
in the face of China, they're putting
00:44:56
out tremendous funding to support
00:44:58
research scientists coming up with those
00:45:00
next set of molecules or therapeutic
00:45:02
modalities that are going to change
00:45:04
lives and improve lives. Maybe you can
00:45:06
comment a little bit on are we funding
00:45:09
through the government enough scientific
00:45:12
research? What's the right steady state
00:45:14
for us? And how do we address the the
00:45:16
points about the Trump administration
00:45:17
being anti-science?
00:45:18
>> Yeah. Well, look, we live in uh partisan
00:45:21
times now where people get spun up and
00:45:23
they're in sort of a toxic polarization.
00:45:26
And the truth is, if we want to know the
00:45:28
facts, is that in the Trump
00:45:30
administration, we have not cut $1 of
00:45:33
NIH funding. We have not cut $1 to the
00:45:37
general Medicaid budget. That is the
00:45:40
overall Medicaid fund. And the proposal
00:45:42
for the future is to increase Medicaid
00:45:45
by $200 billion. So you hear all the
00:45:47
time, oh, Trump cut Medicaid, Trump cut
00:45:49
the NIH. No, what we want to see is
00:45:52
reallocating money at the NIH from just
00:45:55
chemotherapy and proton beam therapy
00:45:58
work to study food as medicine and
00:46:02
school lunch programs. and the
00:46:04
microbiome and gut health. We've got to
00:46:07
start talking about school lunch
00:46:09
programs, not just putting every
00:46:10
six-year-old on ompic. We've got to talk
00:46:12
about the quality of sleep as it as it
00:46:16
is a cause of high blood pressure when
00:46:18
you sleep poorly instead of just
00:46:19
throwing people on anti-hypertensive
00:46:21
medications. We've got to talk about
00:46:23
environmental exposures that cause
00:46:25
cancer, not just the chemo to treat it.
00:46:28
And so, we want to see funding go to
00:46:30
root causes of diseases. And that is
00:46:33
something that that has been
00:46:35
unfortunately in a blind spot because
00:46:38
the culture of the NIH is the culture of
00:46:42
Francis Collins and Tony Fouchy and the
00:46:45
group for the last 50 years that and I'm
00:46:48
going to oversimplify it. The gene is
00:46:50
responsible for our health problems and
00:46:53
the gene can solve all of our health
00:46:55
problems. Well, look, I believe in gene
00:46:57
therapy and we're doing amazing stuff
00:46:58
with that. But where's the research on
00:47:01
why one in six girls today will develop
00:47:04
an autoimmune disease? What's triggering
00:47:07
that antibbody response? What of the
00:47:10
many exposures in the life of a child is
00:47:12
causing their bodies to be triggered?
00:47:15
These studies can be done. It's not that
00:47:17
difficult to model the antibbody
00:47:21
that's involved in type 1 diabetes or MS
00:47:25
and exposures in the environment to see
00:47:28
if it is triggering that same
00:47:30
configuration that the antibbody binds
00:47:32
to. But no one's been interested in it
00:47:34
because everything has been about coming
00:47:36
up with a, you know, treatment when we
00:47:39
have to look at causes,
00:47:40
>> right? And the scientists on the ground
00:47:44
see their funding go away. They
00:47:46
complain. They get media attention.
00:47:48
There's a lot of amplification of those
00:47:51
stories. So is that not the fundamental
00:47:53
truth because the money is being
00:47:55
reallocated to other scientists and
00:47:56
other research institutions?
00:47:58
>> Correct. So um 14% of NIH funding went
00:48:02
to DEI research. 14%
00:48:05
>> 14% of NI NIH grants went to DEI
00:48:09
research
00:48:09
>> and NIH grants are about 40 billion a
00:48:11
year. Does that sound
00:48:12
>> uh it's it's a little over 20 billion in
00:48:14
terms of grants that go out the door but
00:48:17
about 47 billion for the entire NIH
00:48:19
budget because they run their own
00:48:21
hospital and clinical center and others.
00:48:23
>> So um so if you think and and by the way
00:48:26
I'm all for anything that reduces health
00:48:29
disparities.
00:48:30
>> Yeah. and increases access. But these
00:48:32
grants were not doing it. It was just
00:48:35
describing health disparities. Well,
00:48:37
it's it's we already know there are
00:48:39
health disparities. Simply describing
00:48:41
them with another 50 studies in JAMAMA
00:48:44
does not help people who are suffering
00:48:46
from these health disparities. So, um
00:48:50
we've seen money shifted to root causes
00:48:53
and areas of research that we need to
00:48:54
study that we've not studied. At the
00:48:57
FDA, we have put a big emphasis on the
00:48:59
value of hormone replacement therapy for
00:49:01
post-menopausal women. Something the NIH
00:49:05
demonized for the last 22 years, saying
00:49:07
that women shouldn't take it because it
00:49:09
causes cancer. Um, when we came in, the
00:49:12
NIH was a mess. Almost all the money was
00:49:16
going to genetic research, which then
00:49:18
becomes the priority of every academic
00:49:20
institution. They're not studying causes
00:49:23
and food and the microbiome and cutting
00:49:25
edge areas of of of science. And they
00:49:28
just had this myopic focus on one area.
00:49:30
It's an important area, but it's one
00:49:31
area. They were funding the Wuhan lab
00:49:34
to, you know, get bat corona viruses and
00:49:37
insert a furine cleavage site so it
00:49:39
could infect humans. What are you doing?
00:49:41
It's a bunch of mad scientists. Um, and
00:49:44
14% of grants were going to DEI. So the
00:49:47
NIH when we came in was a mess. And
00:49:50
under President Trump, it is massively
00:49:52
being reformed. And Jay Bodyario is
00:49:53
doing a great job.
00:49:54
>> Okay, let's shift over to vaccines. Our
00:49:56
wives had kids around the same time.
00:49:58
Hope yours is doing well.
00:50:00
>> Great. He's great. Thanks for asking.
00:50:01
>> Yeah. And we talked about the HEP
00:50:03
vaccine, which we declined on the day he
00:50:06
was born.
00:50:08
>> Cuz I started going very deep on what's
00:50:11
the origin of the HEP vaccine the day
00:50:13
that the child is born. Why why is this
00:50:16
being given to them? We have no HEP B
00:50:18
exposure in our household. We don't need
00:50:20
it. Doesn't protect anyone else. What
00:50:23
are we doing this for? You end up going
00:50:25
down these rabbit holes and a lot of
00:50:26
again what you mentioned earlier, you
00:50:28
take for dogma and you recognize, wait a
00:50:30
second, there may be some unfounded
00:50:31
principles at play here. I should not be
00:50:34
doing this. And we make a a difficult
00:50:36
decision against the tide and the
00:50:37
recommendations and suddenly you're in
00:50:39
the social conflict with people around
00:50:40
you, right? And it was very hard.
00:50:43
>> You guys recently made some big changes
00:50:44
to the vaccine schedule.
00:50:47
I'd love to hear a little bit about how
00:50:48
those changes were made, what were the
00:50:50
big changes, and then, you know, kind of
00:50:52
what got us to this point where when you
00:50:55
look at the data, you're like, "Wait a
00:50:56
second, right?
00:50:57
>> That may not make as much sense." Yeah.
00:50:59
>> I'm just laughing as you talk, Dave, cuz
00:51:01
you do, you know, you just ask some good
00:51:03
questions like, "Does does my newborn on
00:51:07
the in the first hour of life need to be
00:51:10
injected with a hepatitis B vaccine when
00:51:13
the mom is hep negative?" And within a
00:51:16
matter of weeks of having broader
00:51:17
conversations, you feel like you're a
00:51:19
fugitive of the law, like you've done
00:51:21
something, you know, terribly wrong for
00:51:23
choosing not to vaccinate. We went
00:51:25
through the same thing and and and you
00:51:28
know, being a part of having a kid is so
00:51:30
special. You know, we were talking about
00:51:31
that. So, yeah, we just went through
00:51:33
this. Our son was born about 6 months
00:51:35
ago and, you know, the uh we were
00:51:39
offered the hepatitis B shot. Now, maybe
00:51:41
they figured out who I was and didn't
00:51:43
push it as hard as some of my friends
00:51:45
have had that it pushed on them and we
00:51:47
declined. Um, you're preventing with
00:51:50
hepatitis B an infection that is a
00:51:53
sexually transmitted infection or can be
00:51:55
uh get it from a uh bloodborne pathogen
00:51:59
exposure. Uh, so that's not going to
00:52:01
happen until they're a teenager at least
00:52:03
or further down the road. But when you
00:52:06
ask the question immediately you get
00:52:09
this sort of antivax label or um
00:52:13
>> or you have to qualify that's right
00:52:15
>> I'm not an antivaxer but I'm asking this
00:52:18
what what right what's going on here
00:52:20
this sort of McCarthyism around this uh
00:52:23
schedule which by the way the United
00:52:25
States vaccine schedule was an
00:52:26
international outlier with 72 doses
00:52:28
recommended between the ages of zero and
00:52:30
18. So, President Trump asked us to
00:52:33
review the um international
00:52:37
landscape of vaccine recommendations and
00:52:39
we looked at 20 other developed
00:52:41
countries and found that not only are we
00:52:43
the international outlier in in how high
00:52:46
the number of doses we recommend is but
00:52:48
that there's a consensus of a group of
00:52:50
core essential vaccines and we wanted to
00:52:52
put that in front of the American people
00:52:54
to say look all vaccines are still
00:52:56
recommended by the CDC but here are a
00:52:59
list of core essential vaccines. So we
00:53:01
gave them a list that constitutes about
00:53:03
38 doses from age 0 to 18. And the idea
00:53:06
is to increase vaccination rates among
00:53:11
children that have been dropping because
00:53:13
of a loss in public trust by saying
00:53:15
here's a hierarchy of what we believe to
00:53:18
be a list of core essential vaccines. I
00:53:21
don't want to see someone because you
00:53:23
know a um a doctor's pushing the sixth
00:53:26
COVID booster in a young healthy
00:53:28
12-year-old girl. I don't want to see
00:53:30
the mom say, "Well, I'm not going to get
00:53:32
the measel shot in my next with for my
00:53:34
next child because I am something's not
00:53:37
right about this." 38 is better than
00:53:40
zero. You can still get them all.
00:53:42
They're all paid for, but we have a hard
00:53:44
time in the medical culture, and this is
00:53:47
part of the sort of the sociology of
00:53:49
medicine, meeting people where they're
00:53:51
at. For example, as a cancer surgeon, I
00:53:55
would see women tell me they don't want
00:53:57
to get a mammogram.
00:54:00
I I disagree. I think they're safe, but
00:54:02
a woman may have be concerned about the
00:54:04
radiation, the discomfort, the
00:54:07
inconvenience. 40% of women who are
00:54:10
candidates for a mammog are not getting
00:54:12
a mammogram in the United States today.
00:54:14
Showing you the massive disconnect
00:54:15
between the medical field and where
00:54:18
people are at. Now, you know what we
00:54:20
should be doing is we should tell those
00:54:22
40% of women, how about an ultrasound?
00:54:26
It picks up 90 to 95% of the lesions
00:54:29
that a mammogram would pick up. But
00:54:31
doctors don't recommend an ultrasound
00:54:33
because
00:54:34
you're violating the gold standard and
00:54:36
there's liability and there's, you know,
00:54:38
and you're you're practicing substandard
00:54:41
care and women may tell other women that
00:54:43
they can also get an ultrasound and we
00:54:44
don't want women getting an ultrasound
00:54:46
instead of the paternalism that results
00:54:49
in this disconnect is hurting people in
00:54:53
the United States today. And so with
00:54:55
identifying the list of core essential
00:54:57
vaccines, we are trying to meet people
00:54:59
where they are at to see more
00:55:01
vaccinations because childhood vaccines
00:55:03
have declined over the last four years
00:55:06
of co because people have lost trust in
00:55:09
the dogma of the cloth masks for
00:55:12
toddlers and vaccine boosters in
00:55:14
perpetuity and you have to fire a
00:55:16
teacher if if she already had CO. Ignore
00:55:19
natural beauty. You have they have to be
00:55:21
fired from their job. that um absolutism
00:55:25
has caused tremendous damage and we're
00:55:27
trying to rebuild public trust. What's
00:55:29
frustrating to me to observe is there
00:55:32
are now states like California and the
00:55:34
California DPH that are saying we're
00:55:36
going to set our own vaccine schedule.
00:55:37
We're not going to listen to the FDA, to
00:55:39
the HHS anymore because they don't know
00:55:41
what they're doing because they're Trump
00:55:43
admin. They're not doctors. They're not
00:55:45
scientists. Clearly, this is all
00:55:46
political. And is there a process of
00:55:49
engagement that you and your
00:55:51
organization go through to try and bring
00:55:53
some of these other folks along with
00:55:55
you? Because I think the point you just
00:55:56
made can't be a point that they can
00:55:59
fundamentally disagree with. What is
00:56:02
what is the process by which we can
00:56:03
break the political ranker around things
00:56:07
like vaccines and just take a very
00:56:10
clear-cut scientific approach and get
00:56:12
people aligned around this? Do you do
00:56:14
engagement on this stuff?
00:56:16
>> I don't. Look, I I think it's sad we
00:56:18
have this toxic polarization that's
00:56:20
crept in. It's it's in society, but it's
00:56:23
now crept into medicine
00:56:25
>> and it's a lot of character attacks. I
00:56:28
mean, it was put together by doctors
00:56:30
with impeccable credentials. Tracy Beth
00:56:33
Hogue, MDPhD,
00:56:35
phenomenal epidemiologist who is deep on
00:56:37
the science on this stuff. you know all
00:56:40
of us Jay Badacharia MDPhD memed Oz vice
00:56:43
chair of surgery at Columbia University
00:56:46
I mean these impeccable credentials 400
00:56:48
scientific publications I've published
00:56:51
350 scientific peer-reviewed
00:56:53
publications in my career at the Harvard
00:56:55
School of Public Health at Georgetown at
00:56:57
John's Hopkins on the faculty tenure
00:56:59
national academy of medicine didn't
00:57:01
matter all the impeccable credentials
00:57:02
you can put in front of people there's
00:57:05
this sense of we just have to uh say the
00:57:09
contrarian thing to whatever they are
00:57:11
saying because of this sort of mantra of
00:57:15
all vaccines are good regardless and you
00:57:17
cannot have an honest conversation. I
00:57:19
talked to doctors and they they've never
00:57:21
heard of a vaccine they didn't love.
00:57:23
Anthrax vaccine was a disaster. H3N N3
00:57:27
killed people. It was a disaster taken
00:57:29
off the market. Rotovirus vaccine in
00:57:31
1999 taken off the market because kids
00:57:34
were dying from interception. Roto virus
00:57:38
is not in our core essential vaccine
00:57:40
schedule in the United States. Overseas
00:57:42
it's a little different but in in what
00:57:44
we put out it's not in there. After mass
00:57:47
vaccination with roto virus the number
00:57:49
of deaths per year went from 3 to 1.6
00:57:54
>> or round it up let's say two went from
00:57:56
three to two with mass vaccination
00:57:58
>> and the vaccine that was used up until
00:58:01
1999 was taken off the market for safety
00:58:03
concerns. So when you have a parent ask
00:58:06
a question about the necessity or we
00:58:10
cannot respond with absolutism, American
00:58:12
medicine needs to show some humility.
00:58:16
When I had a patient asked me a question
00:58:18
I didn't know the right answer, I don't
00:58:20
know. Maybe I'll look into that. Maybe
00:58:22
one of my colleagues knows in co during
00:58:25
COVID, the right answer many times was
00:58:28
we don't know.
00:58:30
>> Do you find that there's a path forward?
00:58:33
>> I hope so. So, I mean, we're hoping to
00:58:34
restore gold standard science and just
00:58:37
talk objectively about it. We've had
00:58:39
universities uh cancel uh crush censor
00:58:44
railroad doctors that, you know, pose
00:58:47
different ideas about things. And I'm
00:58:49
not I'm not talking about the political
00:58:50
hot button issues. I'm talking about the
00:58:53
fact that ulcers were not caused by
00:58:55
stress. They were caused by a bacteria
00:58:56
called H. pylori. Well, that guy was,
00:59:00
you know, railroaded. his research was
00:59:02
rejected from the national uh meetings
00:59:05
and then he gets the Nobel Prize because
00:59:06
he ends up being correct. So it's it's
00:59:09
not good for science.
00:59:10
>> Most great scientists start out as
00:59:12
heretics just to be clear by the way.
00:59:13
That's right. Yeah. So Marty, one of the
00:59:15
other big challenges that we talk a lot
00:59:17
about in this country is the cost of
00:59:19
drugs. Healthcare today costs roughly
00:59:23
15% of our GDP. That's an insane
00:59:26
statistic and it is rising year after
00:59:29
year in the United States and it's such
00:59:31
a complex issue. By some measurements
00:59:34
though, the price of drugs in the United
00:59:36
States is almost three times what it is
00:59:39
outside the United States. So I'd love
00:59:41
to hear a little bit about the specific
00:59:43
role of pricing drugs. What sort of
00:59:46
actions have you guys taken and can you
00:59:48
take to help bring down the price of
00:59:50
drugs for patients, for for care
00:59:52
providers, for insurance companies, and
00:59:54
ultimately for the economy?
00:59:56
>> It's been the great American ripoff. You
00:59:58
could buy a GLP-1 drug for $1,300 in the
01:00:02
United States and go to London, it sells
01:00:03
for $88. Or you go to Germany or France
01:00:06
and buy any of the drugs that are cost a
01:00:09
lot of money in the United States and
01:00:10
they're half a third or a quarter the
01:00:13
price. And so, President Trump has given
01:00:16
us a clear charge and he says, "Look,
01:00:17
we're the largest purchasers of drugs.
01:00:19
We want the best price in the developed
01:00:22
world. It's called most favored nation
01:00:24
status pricing. And thanks to Dr. Oz and
01:00:28
and Chris Clamp and others at CMS, we
01:00:30
did our part at the FDA to be a part of
01:00:32
this. Uh we've gotten drug companies to
01:00:34
the table and we've got them to agree to
01:00:36
most favoration status pricing. That's
01:00:38
going to radically lower the price of
01:00:40
drugs. With the GLP1 example, for
01:00:42
example, it's going to come down to $149
01:00:47
for the first three months. Um, other
01:00:49
countries are going to pay more. We have
01:00:51
been financing 60% of the R&D cost to
01:00:54
pharma companies. Other countries need
01:00:56
to pay their fair share. And when it
01:00:58
comes to this president, would be it
01:00:59
NATO membership fees or whatever, he
01:01:01
wants to see other countries paying
01:01:02
their fair share. And so, we're getting
01:01:04
that delivered. Another big way in which
01:01:07
we are going to lower drug prices
01:01:10
is by cutting the red tape at the FDA
01:01:12
for bio biologic drugs. So most 51% of
01:01:18
the So let me back up for a second. The
01:01:21
fastest area of healthc care spending
01:01:23
growth is drug price spending growth.
01:01:27
And the fastest area of drug price
01:01:29
spending growth are a class of medic
01:01:31
medications called biologics. which
01:01:33
means you need a cell line to
01:01:35
manufacture them. And so these are
01:01:37
typically the 60,000 $100,000 $150,000
01:01:41
medications. They have generic versions
01:01:44
called bioimilars.
01:01:47
But the FDA red tape to get a bioimilar
01:01:50
approved has been so long and arduous it
01:01:52
takes 5 to 8 years and $300 million or
01:01:56
so. We have changed the requirements so
01:01:59
that we use the same principles we use
01:02:01
for small molecules. If you are
01:02:04
structurally the same as a small
01:02:07
molecule branded drug, we're going to
01:02:09
approve you with some other
01:02:10
stipulations. And so we are reducing the
01:02:14
cost of R&D of biosimilars by a hundred
01:02:16
million plus dollars and we are
01:02:19
shortening the time frame from 5 to 8
01:02:21
years to 2 and 1/2 years or more. And so
01:02:24
we're going to see a whole new class of
01:02:26
biosimilars come out in this
01:02:28
administration that are going to finally
01:02:30
compete
01:02:31
>> with the biologics. Now humumera is one
01:02:33
of the most famous biologics. It took
01:02:35
years after that patent market
01:02:37
exclusivity for a bio similar to come
01:02:39
out and when one did come out you didn't
01:02:42
see the price of hum come down that much
01:02:45
almost sort of an an implied price
01:02:47
collusion. We need a lot of biosimilars
01:02:50
to come out and we're going to see the
01:02:51
floodgates open up on biosimilars. And
01:02:54
then a final point, why are a lot of
01:02:57
drugs requiring a prescription in the
01:03:00
United States?
01:03:01
>> What are we worried about? Somebody
01:03:04
overdosing on anti-nausea medication or
01:03:07
somebody picking up a prostate
01:03:10
medication without a a prescription. And
01:03:12
we've got this is the the paternalism in
01:03:15
medicine again coming out. the same
01:03:16
paternalism that blocked women from
01:03:19
having home pregnancy tests because you
01:03:22
know women can't handle that
01:03:23
information. They have to come in and we
01:03:25
have to share it with them. It's this
01:03:26
paternalism you see and by the way it
01:03:28
happened again with COVID testing. We
01:03:30
saw it well home COVID testing. We
01:03:32
fought this battle. We wanted home COVID
01:03:34
testing and the establishment was like
01:03:36
no no we have to tell them they can't
01:03:38
have this information.
01:03:41
What are why are drugs not over-
01:03:43
theounter? And we're going to so we are
01:03:46
going to get more drugs over the
01:03:47
counter. And let me tell you why that
01:03:49
lowers drug prices. Because when a drug
01:03:52
is on the shelf in a store, there's a
01:03:55
price underneath of it. And there is
01:03:58
something magical with competition and
01:04:00
people who shop. Even if a small segment
01:04:03
of the consumer market is shopping on
01:04:04
price, it keeps prices in check for
01:04:07
everybody. And so you will enable price
01:04:10
transparency
01:04:12
and you will bypass the crazy money
01:04:15
games of PBMs, pharmacy benefit
01:04:17
managers. When you pick up something
01:04:19
behind the counter, they ring you up.
01:04:22
You have no idea the shell game that's
01:04:24
going on behind the scenes. Your with
01:04:26
your employer is getting ripped off and
01:04:27
your PBM is is making money on this and
01:04:30
the broker who sold the PBM to the
01:04:33
employer group could be making $6.50 50
01:04:36
cents on every prescription set for
01:04:39
what? For the for the PBM just to tell
01:04:41
you what your co-ay is going to be and
01:04:43
set the co-pays. All of those money
01:04:45
games disappear with the with the
01:04:48
disinfectant of sunlight and a price on
01:04:50
the shelf. We want to see a mass
01:04:52
transition to more nonprescription
01:04:55
drugs. We have new leadership that I
01:04:57
brought in at the office of
01:04:59
non-prescription drugs at the FDA. We
01:05:01
want to see companies request to to be
01:05:04
non-prescription
01:05:06
and it it's going to have very simple
01:05:08
criteria. If your drug does not have
01:05:11
abuse potential, if your drug is safe,
01:05:15
if your drug does not require laboratory
01:05:17
testing, which doctors, you know, we
01:05:19
often need to check your liver function
01:05:21
tests. It does not need to be closely
01:05:23
tracked. It should be able to be over
01:05:26
the counter. If you're not going to use
01:05:27
the drug in some meth lab to make some
01:05:30
dangerous street drug,
01:05:32
if you meet those basic criteria, the
01:05:35
drug should be nonprescription. Think
01:05:37
about the number of useless ER visits
01:05:40
out there. Uh the whole medical
01:05:42
industrial complex ch-ing every time you
01:05:46
need a refill. Like I got pink eye from
01:05:48
my kids and it was such a headache to
01:05:50
get the drops to get my pink eye to go
01:05:52
away. Like I mean I can't I spent so
01:05:55
much money just getting a few drops of
01:05:57
antibiotics to put in my eye. But if I
01:05:59
were able to buy that medicine the
01:06:00
antibiotic drops over the the counter or
01:06:02
and I could just pick it up the shelf.
01:06:03
How do I get my insurance to pay for it?
01:06:05
How does that process work? Just explain
01:06:06
to the everyday consumer what that's
01:06:08
going to look like.
01:06:09
>> So we need insurance companies to to um
01:06:12
modernize how they reimburse for
01:06:15
medications. And we're having these
01:06:16
conversations internally as well because
01:06:19
they had this old construct of here's
01:06:21
our reimbursement scheme for
01:06:22
prescription drugs and here's our
01:06:24
reimbursement scheme for
01:06:25
non-prescription drugs. Well, they got
01:06:26
to modernize. We've got to come up to
01:06:28
the 21st century. And remember, the
01:06:30
insurance companies own the PBMs a lot
01:06:33
of times. So, we've got to be honest. We
01:06:35
got to all come to the table.
01:06:36
President's bringing them all to the
01:06:38
table and having very frank
01:06:39
conversations. And he's been successful.
01:06:41
I've got to imagine at 15% of GDP, this
01:06:44
is a giant ship you're trying to reset
01:06:46
and redirect. Can you get this done in
01:06:49
this administration? Can you make the
01:06:51
changes of moving many of these
01:06:52
medications over the counter and get
01:06:54
them to fit under insurance uh
01:06:56
reimbursement plans?
01:06:57
>> It's a massive priority this year for
01:06:59
me. My one of my big 2026 goals is that
01:07:02
we want to see more drugs move to
01:07:04
nonprescription. I if writing a
01:07:07
prescription by a physician like myself
01:07:09
is supposed to regulate and serve as a
01:07:13
way to administer drugs judiciously,
01:07:17
then history would show we failed.
01:07:19
Opioids and Oxycontton
01:07:22
uh 60% of antibiotics prescribed in the
01:07:25
United States are unnecessary. That
01:07:27
study has been done over and over again
01:07:29
10 different ways. Most antibiotics
01:07:32
people take they should not be
01:07:33
prescribed. Um, so we have to talk about
01:07:38
educating people, trusting people, and
01:07:40
get away from the paternalistic model of
01:07:42
medicine.
01:07:43
>> Yeah. And well, I mean, look, if you
01:07:44
guys get it done, I think it'll be a
01:07:46
profound change for America for the the
01:07:49
price of healthcare, which I think is
01:07:50
really challenging a lot of people
01:07:52
dayto-day. One of the other things
01:07:54
that's been a little bit of a hot button
01:07:55
is pharmaceutical advertising on TV.
01:07:58
Yeah,
01:07:59
>> some people have claimed that the
01:08:00
pharmaceutical companies have
01:08:02
significant influence over media because
01:08:03
of the money they spend. They're one of
01:08:05
the biggest spenders. I spoke to a
01:08:06
pharmaceutical CEO about advertising. He
01:08:08
said the ROI is incredible. We've never
01:08:10
been able to influence media, so it
01:08:12
doesn't make a difference to us in that
01:08:13
sense, but fundamentally the reason we
01:08:15
do it is because it gets awareness out
01:08:17
there for therapies that uh patients
01:08:20
might not know are available to them.
01:08:22
and he said this interesting statistic
01:08:23
to me which is that half of US
01:08:26
physicians never see a representative to
01:08:28
learn about new uh drugs that are coming
01:08:29
to market and uh twothirds of physicians
01:08:33
report never reading a journal article
01:08:36
or going to a conference in the past
01:08:37
year. So they're not aware of some of
01:08:39
the new medicines that have come to
01:08:40
market or coming to market. You've been
01:08:42
a physician, you are a physician, you
01:08:43
understand how this might go. You're
01:08:45
busy. You're treating patients. You have
01:08:46
a lot going on. Maybe you're not up to
01:08:48
speed on on the newest medicines coming
01:08:50
to market. What's the administration?
01:08:52
What's your view on advertising,
01:08:53
pharmaceutical advertising on TV? Where
01:08:55
are things headed?
01:08:56
>> Well, raising awareness, as your uh
01:08:59
friend mentioned, is a good thing, but
01:09:02
creating a misleading impression and
01:09:04
creating a massive storm of demand where
01:09:07
patients come knocking on our door,
01:09:09
insisting and begging that they get
01:09:10
certain medications that are not
01:09:12
indicated for them is a problem. and the
01:09:14
drugs that they are advertising non-stop
01:09:16
on TV and and they're always singing and
01:09:19
dancing, right? Always singing and
01:09:22
dancing or marching from some fake town
01:09:25
to another. I don't know where they're
01:09:26
going, but it's always this sort of idea
01:09:28
that life is great once you take this
01:09:31
medication. Um, it's the biologics that
01:09:35
they're advertising. And because they
01:09:37
charge so much on the biologics, and
01:09:40
look, they do cost a lot more to make,
01:09:42
but because some of these biologics have
01:09:44
been so expensive, that's where they're
01:09:47
seeing this big ROI. So, we are lowering
01:09:49
drug prices, and I think that's going to
01:09:51
affect um whether or not it's worth it
01:09:54
for them to advertise. We have a duty at
01:09:56
the FDA to enforce two regulations that
01:09:59
were not enforced in the Biden
01:10:01
administration and that is that ads
01:10:03
cannot create a misleading impression
01:10:06
and that there has to be a quote unquote
01:10:08
fair balance of information. There's
01:10:10
also a loophole called the um
01:10:14
uh adequate provision loophole which
01:10:17
says you don't have to list all the
01:10:19
risks or side effects. You can put it
01:10:21
somewhere else like on a website. We're
01:10:23
closing that loop. We're changing the
01:10:25
regulation to close that loop. The Biden
01:10:27
folks in the year before I came to the
01:10:30
FDA sent out zero enforcement letters. A
01:10:33
department of about 35 people in charge
01:10:36
of sending out enforcement letters sent
01:10:39
out zero enforcement letters. I sent out
01:10:42
1,500
01:10:44
enforcement letters, including over a
01:10:46
100 cease and desist letters for ads
01:10:48
that were creating a misleading
01:10:50
impression, including onlineies that are
01:10:52
advertising drugs without the same uh um
01:10:56
side effects that pharma companies list
01:10:58
when they do the ads. And so we are
01:11:01
cracking down on it. We want free
01:11:04
speech, but we also want fair speech.
01:11:06
And this is part of our jurisdiction.
01:11:08
So, uh, so we are taking this very
01:11:10
seriously. I I'd personally love to see
01:11:12
pharmaceutical companies spend that 20
01:11:15
to 25% of their money that they spend on
01:11:17
marketing, take some of that and use it
01:11:19
to lower drug prices for everyday
01:11:21
Americans.
01:11:22
>> Okay, great. Well, sounds like there's
01:11:25
some balance and change that's required.
01:11:28
One of the other things that we talk a
01:11:29
lot about in Silicon Valley is this
01:11:32
shift in AI and using AI to diagnose
01:11:35
your condition. And so many stories have
01:11:36
come out where people upload their lab
01:11:39
data or an MRI image and they're getting
01:11:43
readouts that they weren't getting from
01:11:45
the doctor or more accurate readouts or
01:11:47
they're able to find care that they
01:11:49
weren't finding through the traditional
01:11:51
physician process. What's this
01:11:53
administration's view on these AI tools?
01:11:56
Are they a supplement, a replacement?
01:11:59
And then how do we allow them to
01:12:01
proliferate if they're they're good? And
01:12:03
do they need to be regulated? or are we
01:12:04
going to end up regulating these AI
01:12:06
doctors, these AI medical systems?
01:12:08
>> Well, first of all, AI is producing
01:12:11
information at a rate that no one can
01:12:14
keep up with. And so, if we use the
01:12:16
traditional regulatory mindset to say we
01:12:18
have to make sure the information is
01:12:20
accurate, then you wouldn't be able to
01:12:22
do a Google search because you're going
01:12:23
to get a hit that's going to give you
01:12:25
something that's not accurate. And so,
01:12:26
what are we doing? What road are we
01:12:28
going down? We can't outrun this lion.
01:12:30
We have to use common sense and
01:12:32
demarcate information that you're
01:12:35
getting from AI that automatically
01:12:39
triggers some health intervention that
01:12:41
is sort of automated AI. And so last
01:12:44
week at the Consumer Electronic Show, I
01:12:46
outlined new guidances on AI decision
01:12:49
support and wearables. And it creates a
01:12:52
a clear consumer lane. But if you're
01:12:54
making medical claims of a uh medicalra
01:12:59
blank, then that's something we're going
01:13:01
to want to take a look at and that's
01:13:02
something you're going to want the FDA's
01:13:04
seal about. So, it creates
01:13:05
predictability because developers tell
01:13:07
me all the time they just want
01:13:09
predictability from the FDA. Markets
01:13:11
want predictability, developers want
01:13:13
predictability, and investors want
01:13:14
predictability. So wearables meaning
01:13:16
heart rate, blood pressure, that's
01:13:18
right. Glucose monitors, those sorts of
01:13:20
things get deregulated, more accessible,
01:13:23
lower price, and so on.
01:13:24
>> That's right. They're going to be
01:13:25
deregulated. So you can give those
01:13:27
results of any physiologic parameter.
01:13:30
But if you say that it's a quote unquote
01:13:33
medical grade blood pressure, then we
01:13:35
are going to want to see the data to
01:13:37
make sure that it's validated with the
01:13:39
gold standard blood pressure readings.
01:13:40
We don't want people redosing their
01:13:43
blood pressure medications on something
01:13:46
that claims to be medical grade when it
01:13:48
it is not medical grade.
01:13:49
>> Got it. Okay. One other area I've spent
01:13:51
some time in in my career is in
01:13:54
alternative proteins. And this is
01:13:56
something that your agency regulates. So
01:14:00
making animal proteins, eggs and cheese
01:14:02
and milk and so on using bacterial or
01:14:04
yeast cells rather than making them from
01:14:06
the animal. You get the same protein.
01:14:08
and you just use a different mechanism
01:14:09
of making that protein or cellular meat
01:14:12
where they're actually growing the
01:14:13
chicken breast or growing the the beef.
01:14:16
Um there's historically been a system
01:14:19
called grass are generally recognized as
01:14:21
safe that a lot of the companies have
01:14:24
relied on as they've developed these
01:14:26
techniques and these protocols. You've
01:14:28
made a few changes. Maybe you can kind
01:14:29
of highlight the balance between
01:14:31
innovation because the benefit of these
01:14:33
systems, lower cost, less energy, and
01:14:36
you take the animal out, less cruelty.
01:14:38
There's an ethical driver for some of
01:14:40
us.
01:14:40
>> Yes.
01:14:41
>> But I'd love to hear the view on
01:14:43
balancing those benefits against the the
01:14:45
risks to consumer health. And there's an
01:14:47
incredible amount of lobbying pressure
01:14:49
from ranchers and animal agriculture
01:14:50
against these systems that I'm assuming
01:14:52
is starting to kind of make its way into
01:14:54
DC. we've seen it make its way into
01:14:56
states where they've banned it outright
01:14:58
banned cellular meat in some states. So,
01:15:00
I'd love to hear your view on this kind
01:15:02
of alternative protein market and the
01:15:04
changes you've made in grass and and
01:15:06
looking out for consumers against the
01:15:07
benefits.
01:15:08
>> Um, you're making me hungry because I
01:15:10
love eggs and I didn't get my egg
01:15:13
breakfast this morning because we're out
01:15:14
here at a bunch of meetings.
01:15:16
>> But, um,
01:15:16
>> I'll get you some eggs afterwards.
01:15:18
>> Great. And not egg white only. I I do
01:15:21
not believe in egg white only. I mean
01:15:23
that is what are we doing? Egg white
01:15:25
only eggs. I mean that's sort of the
01:15:27
ultimate epitome of the old dogma. Um
01:15:30
and and by the way my uncle um he came
01:15:33
to the United States. He had eaten eggs
01:15:35
every morning and he loved eggs. It was
01:15:38
his livelihood is the morning eggs. And
01:15:41
he came to the United States in his 30s
01:15:43
and his doctor said no eggs. You know
01:15:46
found out he was eating eggs and just
01:15:48
you know wagged the finger and you know
01:15:50
stopped. And so for 30ome years, he had
01:15:54
this miserable life without eggs until
01:15:56
we finally got to him and said, "It's
01:15:58
okay. Two eggs in the morning is okay.
01:16:00
It's a good source of protein. Don't
01:16:02
worry about the saturated fat." He's now
01:16:04
95 years old, I believe, in Florida.
01:16:06
>> A happy man.
01:16:07
>> Happy man eating his eggs every morning.
01:16:09
>> I'm a two to three egg a guy as well. So
01:16:11
>> Oh, you are? Okay. It's a great source
01:16:12
of protein. Yeah. So um on grass, so
01:16:16
grass uh for those who may not know is a
01:16:20
way in which companies have created
01:16:22
chemicals or brought in chemicals from
01:16:25
the environment, added it to food and
01:16:27
they could self-declare them as safe.
01:16:30
And so u it's kind of a unique thing in
01:16:32
the United States and it was started
01:16:33
with good intentions so that the FDA
01:16:36
wouldn't regulate you know salt and
01:16:38
butter. You know what are we doing
01:16:40
regulating salt? I'm sure some people
01:16:42
want may want to, but we're, you know,
01:16:44
we're not going to regulate salt. So,
01:16:45
grass was created for for those sort of
01:16:48
things like salt, but then over time it
01:16:50
got abused. So, all the of these
01:16:52
engineered chemicals
01:16:54
would just get a free pass. And we've
01:16:57
said, look at where we are today. Uh,
01:17:00
you turn over the packaging of some of
01:17:01
these ultrarocessed foods and there's 40
01:17:03
ingredients. Nobody knows what they are.
01:17:06
And uh in Europe they have basic
01:17:10
principles of introducing chemicals.
01:17:12
Basically it's it's sort of if you will
01:17:14
uh guilty until proven innocent that is
01:17:17
you have to demonstrate safety to be
01:17:18
introduced. In the United States we have
01:17:20
this you know uh innocent till proven
01:17:23
guilty. So we have basically said we
01:17:26
have a thousand chemicals plus in the US
01:17:29
food supply that do are not allowed in
01:17:32
other food supplies.
01:17:34
Froot Loops was making cereal for Canada
01:17:38
where the petroleum based diets were
01:17:40
banned and a different Froot Loops for
01:17:42
the United States for American kids. And
01:17:45
so we've said we have to close the
01:17:47
loophole on grass. We started the
01:17:48
regulatory process to do that. And then
01:17:51
we have to think about creatively those
01:17:53
situations you mentioned where there may
01:17:56
be ways to get more amino acids in some
01:17:59
of these foods. And we know that kids
01:18:01
are low in amino acids and protein
01:18:03
because of this myopic focus on fat as
01:18:05
the boogeyman. We have not gotten the
01:18:07
protein that we need. And and part of
01:18:09
that was also flawed studies
01:18:11
approximating how much protein your body
01:18:13
needed that used ura nitrogen levels
01:18:16
that massively underestimated the amount
01:18:18
of protein metabolism in your body. And
01:18:21
every food has different levels of
01:18:23
protein bioavailability and amino acid
01:18:26
bioavailability. So that's why you said
01:18:27
you're vegetarian. you have to think a
01:18:29
little differently about the protein
01:18:31
requirements. Uh so all fun top
01:18:33
>> but the cellular meat industry you don't
01:18:35
think is doomed. There's a potential for
01:18:37
the industry and
01:18:38
>> it's going to continue to evolve.
01:18:39
>> We've seen under my time at FDA we've
01:18:41
seen new cellular uh food products come
01:18:44
not just beef but seafood.
01:18:46
>> Yeah.
01:18:46
>> And it happens at the state level and
01:18:48
the FDA actually does not have
01:18:50
jurisdiction over what somebody creates
01:18:52
but we do ask for a registration in a
01:18:55
sense to be in the loop.
01:18:57
>> Okay. So what is causing autism in the
01:18:59
United States?
01:19:00
>> Yeah,
01:19:00
>> there was a conference a few weeks ago.
01:19:03
You and um Secretary Kennedy talked
01:19:05
about Luca Vorin as a new line of
01:19:08
treatment for autism patients, but some
01:19:11
people have since debated the merits of
01:19:12
the data. Are we seeing rising autism
01:19:15
rates in the United States? And what are
01:19:16
the core drivers? What have you learned?
01:19:17
And is this an ongoing process?
01:19:19
>> Well, there is more diagnosis for sure.
01:19:22
Um, but one in 12 boys in California now
01:19:25
being diagnosed with autism. I mean,
01:19:27
that you you didn't see that two
01:19:29
generations ago. You didn't see the
01:19:31
repetitive ticks and the self harm and
01:19:34
the you didn't see that. You still don't
01:19:36
see people in their 60s and 70s with
01:19:40
those uh symptoms at the rates that you
01:19:42
do in young kids today. So, something's
01:19:45
going on for sure. Now, what's causing
01:19:47
it? I don't know, but there's some
01:19:48
interesting hypotheses. One is that for
01:19:51
some kids it may be an autoimmune
01:19:53
phenomena triggered by something where
01:19:56
the antibodies are binding to the folate
01:19:58
receptors preventing folate from
01:20:00
entering the bloodb brain barrier.
01:20:02
Folate is necessary for neural
01:20:03
development. And so some doctors report
01:20:06
and they're I mean these are experts in
01:20:08
the field been studying this their whole
01:20:10
lives and see a lot of patients. They
01:20:12
have observed that if you give
01:20:15
f um lucavorin as an example which
01:20:18
bypasses the blocked receptor allowing
01:20:20
methylated folate to get into the bloodb
01:20:22
brain barrier they have seen clinical
01:20:24
improvement. There's one study that's
01:20:26
looked at the microbiome which we now
01:20:29
know produces a lot of molecules
01:20:31
involved in brain health. 90% of your
01:20:34
body's serotonin which is involved in
01:20:37
mood is made by your gut. And we're just
01:20:41
recognizing this giant frontier of the
01:20:43
microbiome. And so when we in the modern
01:20:46
world, we we just torture the
01:20:49
microbiome. I mean, so many things.
01:20:52
>> Some things are necessary like
01:20:53
C-sections, not good for the microbiome.
01:20:56
Uh infant formula instead of breast
01:20:58
milk, not good for the microbiome. Um
01:21:01
antibiotics used like candy. The average
01:21:04
2-year-old has already received over 2.5
01:21:07
courses of antibiotics. It's carpet
01:21:10
bombing your microbiome in certain
01:21:12
places. And what results is bacterial
01:21:13
overgrowth, less biodiversity, and you
01:21:16
have more inflammation later in life.
01:21:18
And when you have inflammation of the
01:21:20
gut, most the most painful thing in
01:21:22
medicine is when a tubular structure
01:21:26
stretches.
01:21:28
A kidney stone supposedly is the most
01:21:30
painful thing. I've never had one.
01:21:31
Patients say it is. It's not it's not
01:21:34
the stone scraping along the lumen. It
01:21:37
is the blockage causing distension
01:21:40
proximally stretching the urer that's
01:21:43
what hurts gallbladder pain stretching
01:21:46
the gallbladder that's what hurts like
01:21:47
crazy and the GI tract with low levels
01:21:51
of inflammation is irritating that lumen
01:21:55
and also causing this sort of um
01:21:58
discomfort at a low level and and for a
01:22:00
kid it may manifest as feeling sad or
01:22:03
depressed and so we give kids all these
01:22:07
chemicals and ultrarocessed foods. We
01:22:09
alter their microbiome
01:22:11
and we change the production of what
01:22:14
comes out of the microbiome cells
01:22:17
normally. That is certain vitamins, um,
01:22:20
hormone regulation, serotonin. And what
01:22:24
are we doing? We're ignoring this
01:22:25
physiologic cause and we're drugging our
01:22:27
nation's kids at scale.
01:22:29
>> So, we've got to talk about the value of
01:22:31
mic the microbiome. And I would not be
01:22:34
surprised if we had the research on that
01:22:36
instead of just the DEI stuff we talked
01:22:38
about and study the microbiome the same
01:22:41
way we were funding the Wuhan lab to
01:22:44
study corona virus you know
01:22:45
manipulation. I think we could finally
01:22:48
understand
01:22:50
this great frontier of medicine that may
01:22:52
be involved in autism. One study has
01:22:55
found that if you give a certain
01:22:56
protease
01:22:58
it can it's a randomized trial. I
01:23:00
couldn't believe it when I saw it
01:23:01
because and you know sometimes the
01:23:04
studies are not reproducible in JAMAMA
01:23:07
our most widely circulated medical
01:23:09
journal a randomized trial giving a
01:23:12
protease to kids with autism and
01:23:14
noticing a an improvement now again it
01:23:18
needs to be replicated I don't know if
01:23:19
it's real but maybe there's something to
01:23:21
the microbiome so I don't know what
01:23:23
causes autism but we have some clues and
01:23:26
this is something worth studying not
01:23:28
just is there a genetic cure for autism.
01:23:32
>> Yeah. And the underlying environmental
01:23:35
contributors, there's just so much going
01:23:37
on that's different in our environment,
01:23:38
in our food system that are also being
01:23:41
addressed that over time hopefully will
01:23:43
result in maybe less of the general
01:23:46
health effects caused by call it an
01:23:48
adverse environment.
01:23:50
>> Yeah. Yeah, I mean there the number of
01:23:51
proteins that we ingest that are
01:23:53
denatured in some way. The number of
01:23:55
chemicals or molecules that do not
01:23:57
appear in nature that go down the GI
01:24:00
tract. What's happening is you're
01:24:01
getting an inflammatory response, but
01:24:04
it's not a sudden acute inflammatory
01:24:06
response. It's a low-grade response and
01:24:08
it may be causing general body
01:24:10
inflammation. And the one thing I wish I
01:24:13
would have learned in medical school is
01:24:15
that most chronic diseases are from
01:24:17
general body inflammation and insulin
01:24:20
resistance. Heart disease, for example,
01:24:21
most common cause of death in the United
01:24:22
States. We thought it was just saturated
01:24:25
fat. Three large studies failed to show
01:24:28
that association. The Minnesota heart
01:24:30
study was supposed to be the endall
01:24:32
randomized trial in the 1960s.
01:24:35
It showed the opposite of what they
01:24:37
thought. The low-fat diet group, this
01:24:39
these are 9,000 motans randomized.
01:24:42
Low-fat group had more heart attacks,
01:24:44
not less.
01:24:46
>> They suppressed the results for 16
01:24:48
years. When Gary Tobs asked the uh the
01:24:52
senior author before he died, why didn't
01:24:54
you publish this for 16 years? He said,
01:24:57
we just the results just didn't turn out
01:24:59
the way we expected.
01:25:01
>> Well, other large studies failed to find
01:25:03
this clear association between saturated
01:25:06
fat. We're talking about normal
01:25:07
saturated fat intake, not massive
01:25:08
overdosing. Normal saturated fat and
01:25:11
heart disease. And so um uh so anyway,
01:25:16
so there are these things that we have
01:25:17
to re-evaluate.
01:25:19
>> Okay, last question. What's most
01:25:21
exciting to you in the frontiers of
01:25:22
science in human health?
01:25:24
>> You know, we at the FDA try to be
01:25:26
referees. So we see um different
01:25:29
technologies competing. For example,
01:25:31
cickle cell disease. There are monoconal
01:25:33
antibbody treatments and there are gene
01:25:35
therapy treatments. Now, we tend to get
01:25:37
excited about one over another, but the
01:25:39
reality is we we don't know which horse
01:25:41
is going to win that race and so we want
01:25:43
to be the referees. I would like to see
01:25:46
in the Trump administration during our
01:25:49
term a cure for type 1 diabetes or some
01:25:52
meaningful treatment for type 1
01:25:54
diabetes. Uh a powerful treatment for
01:25:57
ALS.
01:25:59
um treatments for certain kinds of
01:26:01
cancer where we've seen now PD1 blockers
01:26:04
and K Rass inhibitors melt the tumors
01:26:06
away so you don't need surgery or chemo.
01:26:10
You talk about a health reform, that's
01:26:12
that's more powerful than a lot of the
01:26:14
health reform ideas we have out there.
01:26:16
You don't need surgery or chemo or
01:26:18
radiation. I mean, think about the
01:26:19
reduction in expenditures. Um we'd like
01:26:22
to see a universal flu shot so we're not
01:26:24
guessing every year. something that
01:26:26
gives you lifelong protection against
01:26:28
future strains because it targets a
01:26:30
different part of the influenza virus.
01:26:32
And I would like to see something
01:26:34
powerful for PTSD. Um, a lot of
01:26:37
Americans are still suffering from PTSD,
01:26:41
some from having served in a war. Uh,
01:26:43
these are young people oftentimes who
01:26:46
stood up to serve their country and, uh,
01:26:49
they are suffering. uh we are still
01:26:51
losing 7,000 plus uh veterans a year to
01:26:56
suicide. So the wars are over, but our
01:26:58
men and women keep dying and many of
01:27:00
these wars were unnecessary.
01:27:02
>> I think we owe it to them to deliver a
01:27:05
powerful treatment for PTSD if the data
01:27:08
supports that there's something out
01:27:09
there. So that's one of my personal
01:27:10
goals.
01:27:11
>> You're optimistic about the pipeline
01:27:12
you're seeing there?
01:27:13
>> Very optimistic. I mean, we're just
01:27:14
seeing really interesting stuff. It's
01:27:16
been published in part, so I'm not
01:27:18
sharing anything here that's not public,
01:27:19
but we've seen phase two trial results
01:27:22
that are promising. And I go, you know,
01:27:24
I go Dave to the re scientific reviewers
01:27:27
at the FDA.
01:27:28
>> Yeah.
01:27:29
>> Without their bosses, just one-on-one,
01:27:31
and I ask them, are you seeing anything
01:27:34
early on that looks amazing? Are you
01:27:37
seeing anything in the pipeline,
01:27:38
anything in animal studies that's
01:27:40
actually working in animals that could
01:27:43
extrapolate to humans in a way that
01:27:44
could be a gamecher?
01:27:46
And I'd say 90% of the time they say
01:27:49
nothing really that much of a leap. We
01:27:53
do a lot of non-inferiority studies, for
01:27:55
example, but every now and then somebody
01:27:57
will tell me, "Yeah, there's this
01:27:58
mechanism. It's creative. It's
01:28:01
different. And if it works, it'll be
01:28:03
amazing." and we'll often issue that
01:28:06
company a priority voucher.
01:28:08
>> Um, a treatment came out for a certain
01:28:12
type of congenital deafness. It's a gene
01:28:15
therapy device combination. It came out
01:28:17
in the New England Journal of Medicine.
01:28:18
We read the article because we love to
01:28:20
read these articles. That's our nature.
01:28:22
And we called the company and we
01:28:25
confirmed about a dozen kids got it. A
01:28:28
couple had normal hearing. I mean,
01:28:30
that's amazing. And so we immediately
01:28:33
issued them a voucher. a new treatment
01:28:34
for multiple myoma that was a gamecher.
01:28:37
Three times better than anything out
01:28:39
there now. Uh 80% remission free
01:28:41
survival I believe it was uh at a couple
01:28:44
years out. There's nothing like that on
01:28:47
the market. We called that company. We
01:28:49
had internal discussions within 24 hours
01:28:52
of that abstract being printed in the
01:28:55
pre-conference materials for the
01:28:56
American Society of Hematology. We had
01:28:58
been in touch with that company and
01:29:00
issued them a voucher. What are we
01:29:02
waiting for? Right? What are we worried
01:29:03
about? We have got to move at the speed
01:29:06
that my patients demanded, not at
01:29:09
government speed. So, we are
01:29:11
streamlining and modernizing the FDA.
01:29:13
And we are not wasting time. We're
01:29:15
getting stuff done.
01:29:15
>> Well, for that, I don't know how anyone
01:29:17
could disagree with the sentiment, the
01:29:19
intent. Thanks for the service. Thanks
01:29:21
for the work, Marty. It's been great
01:29:23
chatting today and thanks for being with
01:29:25
me.
01:29:25
>> Great to be with you, Dave. Thanks so
01:29:26
much.
01:29:43
I'm going all in.
