When it comes to public health.
The first year of the second Trump administration has been an unusually busy one and unusually controversial.
Most of this has run through Robert F. Kennedy Jr., the secretary of Health and Human Services.
In just the past few weeks, Kennedy overhauled the government's recommendations for childhood vaccines and revised the so-called food pyramid, promoting animal proteins especially, while downgrading ultra-processed foods, refined carbohydrates and added sugars.
Kennedy's policies affect several agencies under his purview, including the Food and Drug Administration.
The FDA has had a busy year of its own, approving new treatments for several rare diseases, including cancers, as well as for rheumatoid arthritis and HIV.
The agency also approved a non-opioid pain medicine, the first of its kind in many years.
The next few years may be even busier.
The FDA today is not going to be an FDA in a receive only mode.
We're not going to be stingy librarians.
We're going to go into the pipeline, find out what sounds promising and bring that to the forefront.
That is Marty Makary, commissioner of the FDA.
He has been on Freakonomics Radio a few times in the past and he made a brief appearance in last week's episode about brain supplements.
Makary was a longtime surgical oncologist and professor of surgery at Johns Hopkins University.
He's also done a lot of health policy research.
He's published hundreds of papers and three books that critiqued the American health care system.
Running the FDA is McCary's first job in government, and he knows it's a big one.
The FDA regulates 20% of the U.S. economy.
And there are so many aspects to the FDA.
And there are so many things broken at the FDA.
I spoke with McCary in October, but our release of this episode was delayed by the government shutdown.
What's interesting is just how timely the conversation feels right now.
It's always good to get an insider's view from an institution like the FDA.
So today, as we continue our Freakonomics Radio guide to getting better, Marty McCary on food recommendations, drug approvals, public health and what people in the White House like to call Trump derangement syndrome,
If literally, we had discovered and announced the cure for cancer, you would have some people say well, the Trump administration interfered.
They did this too quick.
They did it too slow.
What exactly does Marty McCary's FDA want to accomplish?
That's coming up, starting now.
This is Freakonomics Radio, the podcast that explores the hidden side of everything with your host, Stephen Dubner.
Hey, Stephen.
Marty, how are you?
Hey, great.
It's been a while.
Can I still call you Marty, even though you're... Yes.
What have been the biggest adjustments for you so far in moving from a life of a physician, scientist and author, surgical oncologist now to a government regulator?
Any details or stories would be appreciated.
I was in the operating room the day before my Senate confirmation hearing and then immediately plunged into a whole world of working within government to try to make things better.
I came in with my team and we started doing an assessment.
And it was a very different life, although some of the basic principles applied.
And that is challenge deeply held assumptions.
Make a diagnosis before recommending any treatment option or change, and look at the patterns of dogma to find out where we are doing things just for the sake of doing things, not because it's the right way.
What does McCary mean by the patterns of dogma?
There are a lot of illustrations of this in his most recent book, which is called Blind Spots When Medicine Gets It Wrong, and What It Means for Our Health.
The first chapter is titled The Salem Peanut Trial, How Experts Created an Epidemic.
So I asked him about that.
They thought they were doing the right thing by saying that, to prevent a peanut allergy, just stay away from peanut products early in life.
Turns out they got it backwards.
They forgot about a basic principle in science called immune tolerance.
They never talked to the laboratory scientists who understood immunology.
It turns out that a kid should be exposed to peanut butter at age six months, seven months as early as a kid can eat in tiny little safe doses.
And that reduces the risk of peanut allergies.
But by going in hard with dogma and no data, it became this perpetual vicious cycle where now it was banned in schools.
Talk to me for a moment about FDA approval years ago of OxyContin and what you might have liked to see done differently then.
The approval of OxyContin by the FDA represents one of the moments in FDA's history where it was captured by the industry it was supposed to regulate.
The regulator who approved it for chronic pain.
That is, long-term use, based on a 14-day study that was presented by the company and then went to work for the company after they left the FDA as a scientific reviewer represents that revolving door that we are working so hard to close.
Now I do think the FDA is in a much better place, but we have to remember that this dark point in our history is emblematic of government regulatory bodies that go through times in their history where they're captured by the same industry they are supposed to regulate.
And what about the sugar industry and especially the battle between the sugar industry and, I guess maybe the fat industry?
It seems like the sugar industry did a pretty good job of demonizing fat at the expense of sugar.
Another great example of medical dogma was the dogma that natural saturated fat caused heart disease.
As a result of that dogma, the solution was well stomp out as much natural fat from people's diets as possible.
Schools went to low-fat milk.
They added sugar.
Nobody cared about sugar.
And a group of scientists the whole time were waving a flag in the air saying wait a minute, you've got this wrong.
It's refined carbohydrates and added sugar that are driving up inflammation, that are creating the insulin resistance that's leading to heart disease and other problems.
But the medical establishment locked arms and walked off a cliff together, declaring natural saturated fat the enemy of public health.
We now know they got it wrong and we are rewriting the food pyramid at the FDA in order to set the record straight.
We will end the 50-year war on natural saturated fat.
Let's back up.
Tell me how you came to be FDA commissioner.
How well did you know President Trump and or others in the administration?
Tell us about first getting contacted and then the process.
I had largely been apolitical most of my life, but then...
During the first Trump administration, I had been a vocal advocate for price transparency.
That is hospital price transparency, drug price transparency.
The Trump administration was very interested in big ideas, fresh and different ideas on health care.
So I was invited into the White House.
I shared the proposal on hospital price transparency.
After several meetings, they adopted the proposal.
This turned into the surprise billing executive order, I believe it was.
Is that right?
That was secondary to the main initiative, which was the Health and Human Services rule on price transparency.
For the first time, requiring hospitals to post prices for services, including cash prices.
It was signed as an executive order by President Trump, and it took a few years to kick in.
And that was the basis of the relationships that I had developed with the healthcare team in the White House that I think opened the door to this invitation.
The first calls I got were asking me for recommendations for different jobs in the health agencies.
And so we started a running dialogue.
Then they came to me and said, what do you think about running the FDA?
They had looked at all my research and found that it was really a good fit for this particular agency.
Were you reluctant at all?
It's a big change for you, a big step.
No, I was eager.
I thought this is the most amazing opportunity in the world.
I mean, you can have such a big impact on the world.
In the operating room, I'm impacting one person.
And in my research, maybe hundreds or thousands of people.
But this is so much bigger.
The last time you and I spoke, I believe it was back in 2021.
It was an episode that we called How to Fix the Hot Mess of U.S.
Health Care.
And you said, if there are two fundamental drivers of our broken, costly health care system, it would be pricing, failures and inappropriate care.
Talk to me about how high those are on your to-do list now.
They are still very big priorities in what we do.
We have a tremendous opportunity to lower drug prices for everyday Americans.
And we're doing it through creative ways.
It's not historically the domain of the FDA, but because the health agency heads, that is, the head of the Center for Medicare and Medicaid Services.
That's Mehmet Oz.
Yeah, Oz and Jay Bhattacharya at the NIH.
Because we work very closely together and talk a lot with the Secretary of Health.
We actually come up with ways to lower health care costs together, in synchrony.
You're talking about what people are calling the most favored nation pricing or beyond that?
Yeah, that's a good example.
At the FDA, we're telling companies that if they promise to provide prices comparable with other developed nations around the world that is, give us the best price then we'll give them priority in the review.
And a voucher to get a priority in review has a street value of $500 million, roughly.
Right.
So we're using market incentives essentially to create incentives for companies to lower their prices.
I'm sorry, I'm laughing only because it is the problem that was created historically by the FDA in that very slow drug approval.
That's right.
I mean, this is a good example.
Let's drill down on that a bit more.
The FDA, from my read at least, is being disrupted less than many federal agencies during the second Trump administration.
But it still seems as though you're thinking a little bit from a blank slate here.
Can you just talk about how you were thinking about the agency's remit overall?
As you mentioned, 20 percent of the economy goes through your agency, which is just remarkable because it's not just – pharmaceuticals, but food, et cetera, et cetera.
So I'm curious whether, A you think that remit is perhaps too broad and, B I'd like to know how that very broad remit maps onto your experience as someone who has been pointing out for years the ways in which the system is tangled, where the incentives are often perverse and so on.
Well, we have two problems.
One is overregulation and the other is underregulation.
But by far the problem of overregulation and regulatory creep dominates the business of the FDA and its interface with the US economy.
It's my opinion that we could engage in more deregulatory policies, cut the red tape and challenge the assumption that it takes 10 to 12 years for a new drug to come to market.
If you have the cure for breast cancer.
It does not make sense to me that we put you through a long, arduous process that takes that long, when we can probably make basic assessments on safety in a year or two.
Now, obviously, nobody likes that lag.
Can you talk for a moment about historically how that lag was created?
If you could just kind of walk us through how we got to where we got with the very slow approval and then specifically what you're trying to do about that.
Well, it started off where a scientific reviewer or two would be assigned a file and they would work with a company to ensure that they went through the appropriate steps of doing a preclinical set of studies, to then move on to a phase one trial and then phase two, and then phase three and then review the final application.
But now the applications have gotten so gnarly they can be over 100000 pages, because the FDA wants to see this and they want to see that.
And the companies have got into this arms race by saying we don't want any gotchas to slow down the application.
Let's just throw the kitchen sink of every single data point we have.
And then the FDA says, well, then we need more reviewers to to review these applications.
So then the application comes in, and it gets farmed out to a dozen different offices, each of whom reviews that section of the application and then sends it back to a central office.
And then, of course, because bureaucracies over time naturally grow, That office then submits it to a higher office and then to another desk.
And so you have this giant bureaucracy to the point now where nobody really feels like we need to get the company an answer quickly, as quickly as we can appropriately review the application.
Instead, it's, okay, we've got a year.
Everyone take your time and get your answers back to us within a year.
Well, that's not good for innovation.
We're getting beat by other countries that have a much more nimble regulatory process.
And so we're reevaluating all of it and redesigning the approval process from A to Z.
What are your biggest priorities as FDA commissioner for the next few years?
Let's say, and feel free to tick off a few that you feel you've already either accomplished or are on the way to accomplishing.
My goal is very simple.
Modernize the agency to deliver more cures and meaningful treatments to the American public and healthier food for children.
We're doing a ton on bringing AI into the agency, on removing the nine petroleum-based food dyes, on rewriting the broken food pyramid, on defining ultra-processed foods, on working with USDA to create SNAP waivers so that state taxpayer dollars don't have to go to sugary drinks and junk food.
Common sense things.
We are eliminating animal testing requirements.
We're using big data to identify safety and efficacy after we approve a drug.
We are taking a year-long review process of an application and taking it down to weeks by convening the different offices that applications are farmed out to within the agency.
We are creating incentives for domestic manufacturing of medications.
We are changing the way inspections are done overseas, moving them from announced to surprise inspections, so we get the real answer.
We are redefining baby formulas to promote innovation.
We are making our decisions public.
That is, our decision letters with drugs and devices are all now public.
So a drug developer or an inventor can go and see exactly why a drug was accepted or rejected and see the logic of the review team.
It's going to help innovators understand the system better so it's not a black box.
It's also going to keep companies more accountable, because right now they spin FDA decisions to their shareholders.
Okay, that was a great list.
Let's dig into a few of those.
Let's start with AI.
So it's been a personal frustration of mine that all this compute power and technology and creativity exists hasn't been applied more aggressively to medical diagnosing.
I know there are many, many, many people working on it.
I've spoken with some who have extremely ambitious goals, but it feels as though there should have been more progress made by now, whether it's using AI to forecast drug interactions or, even more excitingly, maybe new treatments.
I know that the FDA has launched something called ELSA, a generative AI tool for FDA employees.
So just walk me through the breadth of how you see AI being fruitfully applied in your realm.
Number one is our regulation of AI software, that is, AI in digital health devices or in an artificial pancreas, for example.
Generally speaking, Our regulation of AI technology has been entirely broken.
I mean, we have been writing on stone tablets.
We don't even understand some of the AI that's out there.
We can't possibly outrun this lion to safeguard the public.
We can't say...
Well, we're not going to allow chat GPT unless we can ensure that every possible health question is gonna give you a perfectly safe answer.
And so we've got to modernize our regulation of AI technology.
I feel like every administration, though.
When the smart people like you come in in a new administration, every single one says too many agencies, too many lawyers, too much indecision, too much time.
And I'm going to change it, but it seems almost impossible to do.
Do you have some secret weapon?
First of all, we are getting things done in record time.
Most of the stuff we've done including, for example, make our decision letters public.
That has been tried here at the agency for 40 years.
We got it done in months.
Why wasn't it able to be done?
For the reasons you said.
It was lawyers and objection and the bureaucracies.
And so we convene people, we make sure everything we do is lawful, and we get things done.
Same with AI for our scientific reviewers.
We should not have this paternalistic approach that oh, we can't let our scientific reviewers at the FDA use Google because there could be a hit that could be inaccurate.
No, we have to move with the times.
And so...
We have created a powerful AI tool that our scientific reviewers can use to review applications, to organize the applications, to provide supporting studies that they can review in depth.
The reviewers here tried an AI tool in a pilot program a few weeks after I came into office.
We call the program ELSA.
And they said gosh, these applications that can be 100000 pages plus are so much better organized with this AI tool.
We found the functions that the scientists need to do, for example, ensuring proper formatting of all the tables in applications.
And so we create a button for that.
It is a check to make sure the formatting meets our standards.
All this would have been done manually.
And so, after a successful pilot, I told my team let's go ahead and make this tool available to all scientists.
It's optional.
They don't have to use it.
But let's make it available by June 30th.
Well, we got it available agency-wide, ahead of schedule, and under budget.
And thousands of our scientific reviewers use it every day totally on their own volition, because we track the number of unique users at the FDA.
So it's very popular.
So I know the FDA approves on average about 50 new drugs a year.
What do you think that looks like in the future?
And within that answer, I'd love to hear you talk about whether you think approving a lot more new drugs is a good goal of the FDA and or, since you also cover food and many other elements of you know, the human condition.
Right, whether you're trying to de-emphasize drug approval or at least re-emphasize healthy habits, including diet and so on.
I do think it is a healthy goal for the FDA to have more approvals each year.
Now we want approvals that are meaningful, that are supported by data and that are powerful things.
We're really interested in meaningful treatments and cures to some of the biggest unmet public health needs in our society.
I wanna see in the next year or two and I do believe we're gonna achieve this very bold goal a cure or meaningful treatment for type one diabetes, for neurodegenerative disorders, For certain types of stage 1 and stage 2 cancer, such that a tumor is eliminated without the need for surgery or chemo or radiation.
I want to see a universal flu shot so that we don't have to guess each year what the strain is going to be.
A flu shot that would give you immunity for decades against future strains that have yet to mutate.
And I do believe very firmly that we need to get a decision out quickly on these potentially promising treatments for PTSD.
We lose 8,000 veterans a year to suicide.
That's more than the entire Iraq and Afghan wars combined.
The wars are over, but our men and women are still dying.
We owe it to them to get a decision out quickly on some of these potentially promising treatments for PTSD.
Some of these potential treatments, including drugs that have been used more recreationally or for anesthetics and so on.
That's right.
People have gone overseas or used some of these products in the black market.
We can regulate this so it can be given safely to Americans who may not have the wealth or access to be able to get them overseas.
Your list is extremely enticing, I'm sure, to anybody within the sound of your voice.
Give me maybe one example with evidence to persuade me that this is not just a pipe dream.
Let's maybe take type 1 diabetes.
What makes you think there is better treatment around the corner?
What are the mechanisms by which that would work and what's been preventing it in the past?
Well, my area of clinical medicine has been pancreas islet transplantation.
And so this is an area very close to my heart.
There's exciting things out there, and I can give you an example.
But let me first say that we are going into the scientific review divisions proactively something that's never been done before and asking them what are the most amazing treatments that you are seeing in the pipeline, even in the most early stage?
And we're asking our scientific reviewers are you seeing any data that's promising, even animal studies, preclinical phase one, even something just based on a mechanism of action?
And if so, we don't want to be in a receive-only mode as an FDA.
We want to reach out to the company and see how we can facilitate, how we can partner.
We will not cut corners on our scientific review safety standards.
That review is impeccably independent, and it will always be independent.
Can you just talk a little bit more about your research or other research there that you feel is promising?
And what would be clinical treatments resulting from that research, if it can be accelerated as you're describing?
There's technology now whereby some companies have started to grow a pancreas cell called the beta cell that is, the cell that makes insulin in a laboratory and then infuse it into an animal or a human to see if it produces insulin in response to the sugar levels inside that individual cell.
And there's some very promising results.
Now these cells historically have gotten rejected by the host, but it may be that that barrier is about to be overcome.
And if so, we want to be there as a regulator during that process and walk them through the regulatory process.
Another example baby KJ at Children's Hospital of Pennsylvania was born with a genetic defect.
That is super rare and you could never do a clinical trial.
There's just not enough babies with this condition.
We directly worked with the family and the doctors and the company that made a gene therapy and enabled that baby to get a gene therapy in infancy, something that would have been impossible to think about in a regulatory framework in any other setting.
And so we are going to do things that have never been done before, because that's the only way we can significantly advance cures and meaningful treatments in certain areas.
So all that sounds promising.
Coming up after the break, what about the controversies and chaos in the Trump health agenda?
I'm Stephen Dubner.
This is Freakonomics Radio.
We'll be right back.
In September, Donald Trump and several health officials, including the FDA's Marty McCary, held a White House press conference to announce what they described as progress in uncovering the root causes of autism.
The meteoric rise in autism is among the most alarming public health developments in history.
There's never been anything like this.
Trump announced that the FDA would direct physicians to limit the use of acetaminophen, which most Americans know as Tylenol, during pregnancy because of an association with autism.
The president of the American College of Obstetricians and Gynecologists said the announcement was quote not backed by the full body of scientific evidence and dangerously simplifies the many and complex causes of neurologic challenges in children.
At the press conference, Marty McCary also made an announcement.
He said the FDA would be changing the label on a drug called Leucovorin to indicate that it could be used as a treatment for autism.
McCary and I spoke in October, shortly after that Lucavorin announcement.
We said this is not a silver bullet.
It doesn't help all kids.
But we were at a point now as a group of scientists where we felt like there is sufficient evidence on Lucavorin to the point where we should make it available to doctors and make the information available to parents of children with autism so they can inquire about it.
Tell us what Leucovorin is, how long it's been used, and what you're proposing it be used for now.
Leucovorin has been around for nearly a century with an impeccable safety profile.
And what we identified is an indication for Leucovorin whereby it can help some kids with autism significantly.
Let's say a group of children with severe autism.
Maybe half have an antibody blocking the folate receptor at the brain.
And leucovorin can help some of those kids because it bypasses that blocked receptor, delivering methylated folate directly into the brain.
The brain can otherwise be starving of that folate.
So it appears to be powerful.
There are studies out there showing a clear clinical benefit because Leucovorin is generic and there are far fewer incentives to do a trial and bring a new indication for an approval with a generic.
We went to the companies and said, look, we see this incredible promising data.
We also see that it's very safe.
Can we go ahead work with you to add cerebral folate deficiency and autism to the indication and allow doctors to use this, so they're not using it off-label?
The data that you were getting that persuaded you that this was a worthy application of Leucovorin, was that coming from claims data and electronic health records and so on, or was it coming from clinical trials, etc.?
?
It came from clinical trials and observational trials.
We started off with the problem of an epidemic of autism.
One in 12 kids that are boys in California now have autism.
You just didn't see this a generation ago.
Something's going on.
Do you think that is necessarily an indication of a rise in incidence of autism, or is it an indication that autism is being diagnosed differently, perhaps more broadly, et cetera?
I think both are true.
But something is going on.
And so we asked ourselves, is there anything out there that looks promising?
And the second, we identified something with a reasonable amount of clinical data to support it.
We thought let's go ahead, given its safety profile, And make this available to doctors who, in their best judgment, may choose to use it.
So let me just make sure I understand.
This was a drug that's already a generic drug, widely available and therefore pretty cheap?
I gather yes.
Yes.
What was it being used for typically already?
It was typically being used in cancer care.
People can have low folate levels.
Got it.
And then, instead of going through the normal I guess review process, to be used for a different treatment.
The FDA just approved it for that treatment.
Is that the way it worked or was there a review process?
We still have a review process which is to review the existing body of evidence to support a label change on that drug.
So we did that process, but we did it by calling the company and said hey, we're reviewing the data.
And if it does go the direction that it appears, we are very interested in working with you to change the label of this existing generic medication.
What will the data collection be now that presumably, Leucovorn will be used much more frequently in the treatment of autism?
Well, this is where working with NIH has really been a pleasure, because we timed our announcement with an announcement by the NIH of grants to track and affirm and look closely at this use to find out which subgroup of kids is the benefit strongest.
And which kids does it not help?
We do know from the experience of very busy, respected clinicians who treat a lot of kids with severe autism that maybe 20 of the kids have a marked improvement with leucovorin.
Maybe another 30 to 40% may have some improvement.
And the rest of the kids, they just don't see.
They can't tell.
So identifying who those are who can benefit the most is a part of the ongoing research.
So that's the lucavorin yes story.
But tell us about the acetaminophen or Tylenol no story and how that kind of took over.
I think the Tylenol story really got legs when Harvard and Mount Sinai published, about a month prior, a review article looking at the body of evidence of studies for and against.
It was 27 studies showing an association between prenatal acetaminophen and autism and about 13 to 14 studies that went the other way.
So the research was mixed.
The dean of the Harvard School of Public Health weighed in and said he feels strongly that there is an association.
And so I think that was the basis for saying we're going to make this information available to individuals.
You know, when you open up a prescription medication or over-the-counter medication, there's a paper folded like 15 times and you open it up and it's got a million words on it that nobody reads.
Part of that is a little section about what we know about in pregnancy.
So we felt that it was reasonable, given the strong views of the dean of the Harvard School of Public Health.
Right, but I'm looking at a Dear Doctor letter issued by the FDA around the time of the press conference that said that while an association between acetaminophen and autism has been described in many studies, a causal relationship has not been established and there are contrary studies in the scientific literature.
Yeah, I wrote that letter, by the way.
Oh, okay, so I didn't mean to cite you to yourself.
So how did that get turned into the headlines, which is that pregnant women should never take Tylenol?
I've watched the President Trump statement and I realized that there were a lot of caveats in what he said.
I guess the question I really want to ask you is this.
The president is obviously not a medical expert.
How do you manage thinking about this kind of announcement going out from a president that seems to, in this case, have caused as much confusion as clarity?
Do you try to say, well, look, that's the president of the United States.
He's going to do what he's going to do, and I need to do my job.
Or do you think going forward?
I would really like to streamline the way that we communicate this kind of stuff to the public.
Well, I think the media coverage on this has been very incomplete, because they'll pull a clip of a phrase that he said, but they leave out that he has said repeatedly in the exact same talk that there are exceptions, that sometimes a woman needs to take it and that ultimately it's between an individual and their doctor.
Those points were left out entirely in our politically charged media landscape.
I don't mean to make you act as a media critic, but what you're describing now has been going on maybe forever, maybe since there was journalism.
When the Democrats are in the White House, that's what conservative media and the conservative voters say, and vice versa.
Do you have any thoughts for how to make coverage, especially of things like this, complicated medical issues, medical issues for which there's almost never an always or never answer?
I think we saw it during COVID.
You had, for example, the American Academy of Pediatrics insist in the first year of COVID that schools should be open in the fall of 2020.
And that was their message until President Trump said the same thing.
And then they flipped immediately.
That kind of contrarian, partisan politics that has now been injected by our medical societies into the narratives creates this kind of polarization that the media loves to feed off of.
And so all I can do as a physician, as a regulator is to speak directly to the data.
Let's talk about DTC, direct-to-consumer pharmaceutical ads.
I know that on September 9th, President Trump issued a memorandum directing your agency, the FDA, to target deceptive pharmaceutical ads.
Can you talk about that?
What constitutes deceptive?
And I have, I guess, a larger question, which is Are you or anyone rethinking the fact that the US is one of, I believe, just two countries in the world that allow direct to consumer pharmaceutical ads?
That's right.
We are one of two countries, along with New Zealand, that tolerate these direct pharma ads at the magnitude that we see to the point where now they dominate the entire television media industry.
It's literally to the point where in every commercial break somebody is singing and dancing or synchronized swimmers or people marching somewhere in some beautiful Pleasantville.
And they're trying to get you to take something.
You don't even know what it's for.
You never even heard about psoriatic arthritis.
And you just feel like, OK, I give up.
I'll take it.
And then you might hear a long list of side effects and you say to yourself, wait a minute, did they just say sudden death as a complication?
And so what we have a responsibility to do at the FDA and jurisdiction by Congress to handle is that claims of a pharmaceutical company have to be supported by clinical data that they present to us.
They cannot make claims that are unsupported, or they cannot advertise in a way that provides an imbalance of information to the point where it's all glowing and there's no side effects.
Okay, but everything that's on TV has presumably gone through that process, yes?
No.
Some of those ads today list no side effects.
Some of them actually have no words spoken.
You will literally see an ad with the name of a drug people dancing and you'll hear music with no words uttered.
And we see online pharmacies doing the same thing now, as if they're exempt and they can make claims about benefits with no mention of side effects.
I know there was an FDA announcement recently recommending the use of organoids or organs on a chip for drug testing.
I gather that is replacing to some degree animal testing.
Could you just walk me through what that means?
What's the upside?
As a layperson, I've read that animal testing is a perfectly reasonable, logical first step for drug testing, but that it often doesn't carry over very well to human treatment.
So tell me what you're trying to get at there and what this organ on a chip might accomplish.
Animal testing is not a very good model to predict how well a drug is going to do in humans.
As a matter of fact, 90 of drugs that pass animal testing do not pass human safety and efficacy testing.
So it's not a good predictor, and it goes both ways.
Sometimes drugs are rejected because they don't pass animal studies, but then they are safe in humans.
Aspirin would have never been approved based on animal testing studies.
But it turns out aspirin is a powerful medication for humans.
So there's a group of treatments and potential cures that have been essentially halted at the animal testing stage, when now we have other ways to test how it works in humans.
Computational modeling and what we call organ-on-a-chip technology, whereby cells are grown in a laboratory and the drug is given to those cells in the laboratory to see how the cells respond.
Those are more predictive than traditional animal testing for a series of drugs.
To me, that sounds like an obvious upgrade from animal testing, but it's taken a long time.
Why did it take so long and what's difficult about it?
Or maybe in what ways is it not as effective?
I don't know.
There's a lot of tradition when it comes to the FDA and regulatory policy.
And investors have gotten used to the predictability of the requirements of the FDA.
We've said we're going to take massive steps in our roadmap to eliminate animal testing requirements, category by category, starting with monoclonal antibodies, where the computational modeling predictive value is amazing, where organ-on-a-chip technology is very mature.
And where the animal testing used is excessive.
The average monoclonal antibody uses 144 chimpanzees.
From an ethical standpoint.
I personally do not believe that God created these animals on planet Earth for us to subjugate and torture with this testing.
How do you think about regulating current and future forms of birth control, including medical abortion treatments?
I know the FDA recently approved a generic version of the abortion pill Mifepristone.
What would happen if the president comes to you and says you know Marty, I don't want those medicines on the market anymore.
At least you know, not in Republican states, for instance?
How are you working through that?
If somebody comes with an idea to the FDA, we'll discuss it.
We will discuss it.
But we do follow the law, and the FDA remains an independent scientific organization.
And that means that people who are above the FDA in authority, that is, the secretary, people in the White House or members of Congress, when they have ideas, we will engage with them and we will have a scientific conversation.
And that's all they ask for is scientific dialogue.
We have no plans to make changes to the drugs that you mentioned.
Talk to me for a minute about funding in general in the public health sphere, not just for the FDA but NIH research, broadly university research.
We've all been hearing about a lot of cuts, a lot of disruption, a lot of confusion.
I would think that medical funding cuts in general are at odds with your mission as a physician scientist leading the FDA.
But maybe there is nuance there that's not obvious to me.
Well, first of all, the media has been very dishonest in reporting government spending on health programs.
For example, it's been reported that Medicaid has been cut, when in fact the Medicaid program budget has increased by 200 million.
Now they did announce they're going to cut waste, fraud and abuse, but net-net it will be an increase for next year.
With the NIH, they also will have an increased budget next year.
So the idea that the NIH budget has been cut is false and it's part of a very partisan media landscape that we have right now.
So when I hear statements like yours, I want to take you at face value.
But I also know a lot of reporters and journalists who know how to do their work and they know people to ask questions of, and they know databases to search and so on.
Are you suggesting that the entire journalistic cohort that's reported NIH, for instance, cuts or cuts to university fundings, are just making it up, that they're getting it wrong, that they're lying?
What's your assertion exactly there?
We live in a very partisan culture.
And so when media outlets repeat something enough, not only do they convince the public, but they themselves believe it.
The NIH budget this year is higher than last year.
And next year, it'll be higher than this year.
So the NIH did propose, of the money spent on grants, there's two portions.
One that goes to the university's dean and their slush fund, and another that goes directly to the researchers.
And they did propose cutting the amount that goes directly to the Dean's slush fund so that they could increase the amount that goes directly to the researchers and fund more research grants.
That was misconstrued in the media as cuts to science and cancer research and all kinds of nonsense.
The other thing the NIH did which some people didn't like is they looked at all their grants and identified grants that were going to descriptive studies on DEI.
These were not projects that reduced gaps in access to care or helped minority communities.
They were just descriptive studies sort of telling us what we already know.
And they said let's pivot that money to fund actual cures on renal cancer and pediatric conditions and Alzheimer's.
That also got misconstrued as a cut.
There's a lot of context to add to some of McCary's claims here.
For one thing, federal spending on Medicaid tends to increase mechanically thanks to population growth and inflation.
So, even though the total number will go up, according to the nonpartisan Congressional Budget Office, Trump's One Big, Beautiful Bill Act will cut spending on Medicaid by close to 1 trillion over the next 10 years, relative to what it would have been otherwise.
Also, the administration did propose a cut of $18 billion to the NIH's 2026 budget.
Congress rejected that proposal, but the administration had already implemented some cuts that disrupted hundreds of clinical trials, including research on cancer and heart disease.
Coming up after the break.
I am laughing because Trump derangement syndrome is real.
I'm Stephen Dubner.
This is Freakonomics Radio.
We'll be right back.
So your boss, HHS Secretary Bobby Kennedy Jr., is obviously an extremely controversial figure.
Tell me where you align with him and maybe where you don't align, especially when it comes perhaps, to vaccine efficacy and adverse events of vaccines.
Secretary Kennedy is asking big questions that the American people are asking.
I think when we get in the business of saying you are not allowed to ask a question, then we take a major step backwards scientifically and get back to an old priesthood that says we will decide where we have already made conclusions, that something needs not to be challenged versus what may be allowed to be challenged.
And if we really believe in the scientific method, as I do, then the way that you address hypotheses is by doing more study.
And I think he's very open to what scientific inquiry ultimately decides.
So, Marty, you've been on this show before as a physician scientist, let's call you.
And I think of you as firmly part of the universe that I and listeners of this show live in.
But there are millions of people out there now who feel that we're living in a different universe during the second Trump administration.
All sorts of norms have been changed.
All sorts of expectations have been altered.
Millions of people are angry and fearful at this change of direction.
So what kind of message do you have for them about this presidency?
You are a member now of the Trump administration, who also is a card-carrying member of the evidence-based scientific community too.
And many feel that those two are in conflict, that it's like a Venn diagram that does not intersect.
So what do you tell your friends, colleagues, strangers who worry about that disconnect?
Well, I am laughing because Trump derangement syndrome is real.
And if literally, we had discovered and announced the cure for cancer, you would have some people say well, the Trump administration interfered.
They did this too quick.
They did it too slow.
There's some derangement by which they have to be contrarians.
And we've never seen that kind of reflex before.
I think it started getting really bad with social media magnified during the politicalization of science during COVID.
In the COVID era, we saw the Biden administration declare that the Democratic Party was the party of science.
And therefore those of us who are not part of the Democratic Party were heretics and should be censored and canceled and sidelined and dismissed.
And so you do have this view that is prevalent in academic medicine, that we should have scientific apartheid in medicine.
If you don't agree... with the Democrat Party view that you should not have a voice.
What I would ask people to do is to remain scientifically objective and recognize we all want the same thing.
We saw during COVID people, regardless of their political background, say hey, wait a minute.
Closing schools for nearly two years, that's bad for kids.
It didn't matter what political party they came from.
They could just speak objectively and scientifically.
Hey, ignoring natural immunity is scientifically illogical.
Hey, putting a cloth mask on a toddler for three years is going to affect their development and provide no added level of protection.
And so you saw a During COVID, during the politicalization of science itself, this rise of people from no political background say hey, wait a minute, let's talk only about the clinical data and let's get back on track.
I'm curious how this job has changed the way you think about medicine and health, maybe more importantly than medicine, whether it's made you rethink, reassess.
Maybe you've learned some things in this job that you hadn't thought about before.
The great part about this job is twofold.
One getting to know the amazing scientists at the FDA who have dedicated their careers to doing the right thing.
And number two, it's the ability to look into the pipeline of what amazing cures are possible where there's early research, and say let's, from an operational standpoint, see if we can move their application to the front of the line.
Let's be an advocate for the American people.
If you're going to manufacture your drug in the United States, that's a national security issue.
We're gonna move your application to the front of the line.
If you're gonna meet a large unmet public health need, we're gonna move your application to the front of the line.
And if you're going to lower your prices to the point where we have the same good price that Europe and other wealthy countries have what we call most favored nation status pricing, we're gonna move your application to the front of the line.
So we can use economic incentives to actually advance public health by leaps and bounds.
The operational challenge is aligning incentives, partnering with the industry, reminding them that our review is impeccably independent scientifically, but that we can partner with them to create a very easy user interface so that cures and meaningful treatments are not getting held up with needless bureaucracies and burdensome websites.
How's morale at the agency?
You sound great, but we've been reading about people scientists leaving on purpose or being asked to leave.
We've been hearing about low morale.
I'm just curious whether you're needing to think about morale as a part of your leadership.
I think about morale every day, and it is overall very strong and getting stronger.
We are in a growth mode.
We are hiring nearly 1,000 scientific reviewers and inspectors.
We are changing the broken old legacy processes at the FDA so that we can do things efficiently and fast without cutting any corners on our thoroughness.
And I think people here have been hungry for it.
I can't tell you how many scientific reviewers come up to me on our beautiful campus and say gosh, I love your new program to get a decision out in weeks.
I have an idea for it.
I want to be involved.
That, again, was Marty Makary, Commissioner of the Food and Drug Administration.
Let me know your thoughts.
I'm guessing you have some.
Our email is radio at Freakonomics.com.
If you'd like to hear Makary on previous episodes of Freakonomics Radio, check out episode number 456 called How to Fix the Hot Mess of US.
Healthcare.
Episode 270 called Bad Medicine Part 3, Death by Diagnosis.
And if you want to hear more about allergies and immune tolerance, check out episode 617, which was called Are You Really Allergic to Penicillin?
Coming up next time on our Freakonomics Radio guide to getting better.
According to Ezekiel Emanuel, most of the wellness advice out there manages to be both too complicated and too simplistic.
So what's his advice?
The most important thing in life is to have a purpose, to help other people, to make the world better.
And wellness is one mechanism by which you can do that.
That's next time.
Until then, take care of yourself.
And if you can, someone else too.
Freakonomics Radio is produced by Stitcher and Renbud Radio.
You can find our entire archive on any podcast app.
Also at Freakonomics.com where we publish transcripts and show notes.
This episode was produced by Alina Cullman and edited by Gabriel Roth.
It was mixed by Jasmine Klinger with help from Jeremy Johnston.
And we had recording assistance from Bill Pollack.
For background research help.
Special thanks to Bapu Jenna, Bob Langer, David Mandel, Kamal Patel, Peter Cohen, Paul Coates, Rochelle Walensky and Ziad Obermeyer.
The Freakonomics Radio Network staff also includes Augusta Chapman, Dalvin Abouaji, Eleanor Osborne, Ellen Frankman, Elsa Hernandez, Ilaria Montenacourt, Teo Jacobs and Zach Lipinski.
Our theme song is Mr. Fortune by The Hitchhikers, and our composer is Luis Guerra.
Take a drink real quick, please.
Okay, he's encouraging me to take a drink.
I like it.
I like that he's a little bossy with you.
That's good.
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