Marty Makary

speaker

939 appearances 6 recordings 5 series first heard Jan 2026 last heard 13 May

Marty Makary’s voice in public audio — every appearance, attributed to the second.

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recordings per month · last 12 months

Recordings per month over the last 12 months — 6 in all, peaking in Jan 2026 with 4.

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Freakonomics Radio · 659. Can Marty Makary Fix the F.D.A.? · 16 Jan 2026 podcast

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?

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.

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.

It was typically being used in cancer care.

People can have low folate levels.

Got it.

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.

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.

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