401: Makary’s departure and Cassidy’s tenuous Senate seat
40m 43s
This week’s podcast covers major upheavals in Washington D.C. impacting healthcare policy. FDA Commissioner Marty McCarrie resigned after months of speculation, driven by conflicts over flavored vape approvals, slow action on abortion drug mifepristone, and criticism from rare disease advocates. His acting replacement, Kyle Diamantis—a corporate attorney and former partner at Jones Day—is viewed as a stable, “normal” leader but lacks medical credentials, which may affect FDA scientific decisions. Meanwhile, Senator Bill Cassidy’s primary election in Louisiana could reshape Trump’s healthcare agenda.
In biotech news, Biogen reported mixed mid-stage results for its tau-targeting Alzheimer’s drug BIIB080; the lowest dose showed cognitive slowing, but the study missed its primary endpoint, and higher doses failed. The company plans to proceed to phase 3. Regenix Bio delayed its Duchenne muscular dystrophy gene therapy application until early 2027, citing FDA turmoil after McCarrie’s exit and leadership changes in the gene therapy division. The podcast also touches on the legacy of Sarepta’s gene therapy and broader regulatory uncertainty. Guests Lizzie Lawrence and Chelsea Ceruzzo discuss the political dynamics behind McCarrie’s fall and the implications of Diamantis’s appointment for drug approvals and public health.
[music] Welcome to this week's episode of The Readout Loud, a weekly biotech podcast from STAT. I'm Alice in DeAngelus. I'm Adam Poristine. And I'm Elaine Chen. It's Thursday, May 14, and on this week's episode, what is going on in DC? FDA Commissioner Marty McCarrie is officially out of the agency. Well, Bill Cassidy, chair of the Senate Health Committee, is at risk of losing his seat in a close primary race. Whichever way both developments play out will have major ramifications on Trump's healthcare policies. Our DC colleagues Lizzie Lawrence and Chelsea Ceruzzo join us to discuss. But first, a recap of the week's news and a word from our sponsor. [music] Drug development and kidney disease needs more than broad, real-world data. It needs precision. Greenocyte IQ, Neterra's kidney-focused clinical genomic database, links genetic, clinical, lab, and claims data across the large longitudinal population of patients living with chronic kidney disease. That means bio-pharmateeums can better identify meaningful patient subgroups, understand disease trajectories, and make smarter decisions across discovery, trial design, biomarker strategy, and commercialization. Greenocyte IQ helps turn kidney genetics into actionable development insight. To learn how real-world evidence can sharpen your nephrology strategy, visit neterra's rena-site IQ at neterra.com/rena-site IQ. There's even somebody who had listened to a previous iteration of the podcast under a different name, Signal, which was-- Signal, yes. Before my time. That was the very, very first podcast. And that was actually done by Luke Timmerman and Meg Turell, who were not stat employees. Their friends of stat. Friends of stat, exactly. Okay, so to shout out our super fans that have listened to all 400 episodes, we have Elizabeth P. Will G. Samantha T. and Jake M. Thank you for supporting us throughout all almost eight years of the podcast. We love you guys. I'm sure there are more people out there who've listened to all 400 episodes. Yeah, if you didn't make the list, reach out to us. I know. I haven't listened to all 400 episodes. So you've been in all 400 episodes. Pretty much. All right, should we get into the news, Adam? Tell us about the latest developments over at Biogen. You know, I'm really glad we've got this Biogen Alzheimer news today because I'm getting tired of every podcast being about obesity. And you know, we're going back to the old school where we used to talk about Alzheimer's in every episode. So yeah, so Biogen reported some mid-stage results from a drug that targets a protein called tau. A lot of people out there obviously who know about Alzheimer's, you know, we got these drugs that target amyloid plaques, remove amyloid plaques from the brain, modestly beneficial for patients. There's another form of toxic protein called tau. They form these tangles that also are toxic to neurons leading to cognitive decline and function in people with Alzheimer's disease. And Biogen is developing this drug. I am not going to try to pronounce the name of the drug because I will get it wrong. I'll call it BIM 080 because that's easier. And that's kind of one of the names. But anyway, mid-stage results out today, sort of weird, sort of interesting, what they showed was that this drug, which again, targets tau, reduced levels of tau, both in the cerebral spinal fluid and the brain. And also correlated with reductions or I should say slowing of disease progression in patients with early stage Alzheimer's. The rub here is that technically the study did not meet its primary endpoint. They were looking at three different dosing regimens of BIM 080 and the lowest dose did the best. The two higher dosing regimens did not do as well. So technically the study failed. However, Biogen really thought the results are great, showed kind of accomplished a lot of the goals they wanted to and have decided to move this drug forward into phase three clinical trials. So, Adam, this is a weird circumstance. You're telling us that the low dose had an effect and the higher doses did not. It's usually the inverse that we see. It is. And so they were looking for a dose response. So you would think that maybe more frequent dosing or higher doses would work better. They didn't show that. The other thing is, this is one of these press releases and we've all come across these where they're actually zero numbers, no data at all. They're basically just describing the results of the study in with words. They are going to be presenting these data at an Alzheimer's meeting in July in London. Thankfully, our colleague Drew Joseph lives in London, works in London and he will be at the conference. So we will have more to say about this drug and the actual specifics, how well it works. I will say that Biogen was using a lot of positive adjectives when I talked to them very, very early Thursday morning. And that's always a red flag. So, I don't know. We'll see. Right. Again, you're right, Elaine. It could be a red flag. Is this another adieu helm in the making? Who knows? Maybe it's better than that. But I do think it is interesting that this is a drug, again, the targets tau. There have been a lot of tau-targeted drug efforts that have been unsuccessful. They've used antibody approaches. This one is an RNA-based drug. So basically, it silences a gene that produces tau. So it basically dials down the production of tau in the body. It's a different approach. It requires an injection in the spine to be administered, which is a little bit inconvenient. But we'll see what the data look like in July. Okay. So, in other readouts, we got data from Regenix Bio. It said today that it's experimental gene therapy for douchan muscular dystrophy produced sufficiently high levels of microdistrophin, which is a miniaturized version of the dystrophin muscle protein that's broken in the disease of douchan muscular dystrophy. Regenix Bio thinks this data would be sufficient for accelerated approval. But as we know, there's been a lot of flux at the FDA, so who's to say what happened to the application whenever Regenix submits it? I think this is a really interesting circumstance, such a sign of the times that Regenix Bio has this positive data, which Adam, maybe you can get into a little bit more in a second, showing the effect of its drug really positive for boys with douchan muscular dystrophy. But it is holding back on its FDA application until kind of the dust settles at the agency. And for good reason, there's a lot of history, there's a lot of backstory, there's a lot to discuss and debate and weigh with the douchan muscular dystrophy field within this field. You have the legacy of the accelerated approval from syrepta, the fact that they've now had to kind of pull back on that, their syreptis gene therapy because of the side effects, because of the health effects of that drug. And unclear stance right now of who is leading not only the FDA, but kind of who are the decision makers within the branch of the FDA that oversees gene therapies. Yeah, I'll send just a touch on the FDA stuff, obviously, and we'll get into it a lot more when we get Luzzi and Chelsea on the show in a second. But you know, when I talked to current Simpson, the CEO of Regenix Bio yesterday for the story, they are pushing back the timeline for profiling this drug, it's called RGX202, this gene therapy, but they didn't give me a firm timeline, but they basically said they probably will file it early in 2027. Their original plan was to file it kind of in the second half of this year. And you know, I asked them why. And yeah, he admitted, he said, look, you know, with all the turmoil that the FDA right now, with the leadership changes, both at the very, very top with McCarty, but also in the seabird division, you know, that regulates cell and gene therapies, you know, in April, it's not obviously left at the end of April. There's a lot of uncertainty and they don't really know who they're addressing when they file. So they feel like both they want to sort of let the dust settle and kind of see potentially whether, you know, new leadership takes over that may be more flexible from a regulatory perspective, they're also going to have longer follow-up data that they'll be able to submit to the FDA so that they feel like that can help them. I think that was a little bit of a negative surprise today. I think the stock is down on the announcement. And though, you know, the results were pretty much from an efficacy and safety perspective. The results were pretty much what people expected to see out of this gene therapy. But again, with all the uncertainty and all the question marks swirling around the FDA, that is the overhang.
for a Duchenne muscular dystrophy gene therapy. You know, again, the legacy of Sirepda, out there and just a lot of the question marks that swirl from that. So I think until we get more clarification from an FDA perspective, I think that's probably the biggest concern. (upbeat music) - If you're a fan of healthcare politics, this is the podcast episode for you because what a week it's been. After days and weeks of rumors and speculation, Marty McCarrie resigned his post as FDA commissioner a couple of days ago. Did he quit overvaping? Was he pushed out? And what's the deal with McCarrie's acting replacement, Kyle Diamantis? Besides his love of hunting with Donald Trump Jr, we'll go deep into all of it with stats Lizzie Lawrence. - And it's not just the FDA where political intrigue is impacting healthcare policy on Saturday, Louisiana voters go to the polls in a closely tracked Republican Senate primary election that pits incumbent Bill Cassidy against two upstart rivals, including a Trump-backed candidate. The outcome of the primary could have far-reaching implications for the Senate and Trump's healthcare agenda. To help us break it all down, stats Chelsea Cerruzo joins the chat. - Lizzie, Chelsea, great to have both of you on the podcast. It's kind of like a stat group chat. - Yeah. Yeah, it's great to be here. Thanks for having us. - All right, Lizzie, let's start with McCarrie. His exit this week almost felt anticlimatic given all the rumors over the past month or so. Break down how the end of McCarrie happened and why. - Yeah, definitely felt anticlimactic 'cause I feel, I mean, Chelsea will relate in our colleague Daniel and you guys probably. I feel like since late 2025, there have been rumors hitting the hill, hitting industry that he was gone. So when this was coming around, I was hard to tell 'cause I mean, McCarrie has kind of had nine lives. I mean, these rumors that have been circulating didn't come from nowhere. I know there's been a concerted effort among some people in HHS to get rid of him for a while. Obviously, we've reported a lot on how the agency has been pretty unstable under his watch. There have been lots of staff departures, unpredictable decisions, especially related to vaccines and rear diseases. But then it kind of things reached a breaking point in the past few weeks with the vaping community was very upset at McCarrie's hesitance to approve flavored vapes quickly. And then the anti-abortion community was upset at his alleged slow rolling of a study looking at the safety of the abortion drug, Mr. Preston. So both of these things seem to have become political headaches for Trump. And the journal reported that Trump got pretty mad at McCarrie specifically on the vaping issue. So he'd made so many enemies. And I think there were a lot of organizational challenges and ultimately they just decided, we need someone new. This might be a glib, but I'm kind of surprised that vaping, it seems to have been the ultimate undoing of McCarrie among all of the other challenges. It seems like even the kind of pro-life segment of, the population, the people that were kind of trying to get Trump to pass more aggressive pro-life measures and take me for Preston off of the market, fell second to the vaping issue. What's going on there? - Yeah, the vaping issue seems like it's the straw that broke the camel's back. The abortion issue is interesting because I think it's, it's hard to tell if McCarrie was truly to blame for the pro-life communities issues with the Miffa Preston study. I think that the entire Trump administration, they realize that abortion restrictions are politically controversial, not politically popular. But McCarrie kind of became the face of the Trump administration's inaction. And obviously this is an issue, especially with powerful, built-acity and Josh Hawley on the health committee. This is an issue that they kind of have to pay attention to. Yeah, on vaping, I mean, there's been reporting that obviously big tobacco companies have been political allies of Trump for a while. He sees the young mega voter constituency as being very pro-vaping. So I think it just became something that that Trump really cared about. - And to jump in here, I mean, I spoke with Senator Josh Hawley on Capitol Hill yesterday. And he fully blamed McCarrie's exit on the Miffa Preston issue. And he told me that he fully believed that McCarrie was blocking a review. That said, I also spoke with Alex Clark. She is a conservative influencer, turning point USA host. She is also pro-life, but she didn't feel like the Miffa Preston issue was necessarily the straw that broke the camel's back. So the sense that I have gotten from this is that there are a lot of issues surrounding McCarrie and people who opposed him have taken this opportunity to sort of project their issues with him in this exit, that he had the flavored vapes problem that he may have, that the Miffa Preston issue wasn't moving as fast as people wanted it to. And McCarrie has just taken a lot of heat for pretty much anything that people had an issue with over at the FDA. - Hey Chelsea, to follow up on that, I wonder how much Ron Johnson, Senator Ron Johnson is a big proponent of the right to try movement. One of the criticisms that McCarrie has gotten a lot is that he talks during his time at the FDA, he talked a lot about accelerating, accelerating approvals for rare diseases, yet the FDA under his watch seemed to put up more restrictions and make it more difficult for these kinds of drugs for rare diseases to get approved. Did that play, did that play a role though? Was that just sort of all part of the, kind of all the part of the piling on McCarrie from Congress's perspective? - I think it was part of the piling on and also from these lobbying and interest groups, they were unhappy with how he handled rare diseases. And then Lizzie, I know, is reported on that as well. I think to take this kind of where we are now, the acting commissioner Kyle Dementus, pronouncing his name right, he came from the first Trump administration, he's been part of this administration and he was a big part of right to try at that time. What I get out of that personally is that, he is maybe going to be the one to address sort of these issues that people have had. That remains to be seen. I mean, again, the pro-life issue remains a big part of it and Josh Hawley told me that he was going to be looking into Dementus connections to the pro-life movement and if it matches up with what he wants. But yeah, I think it really comes back to this sense of McCarrie wasn't doing anything that made it, a lot of people happy or he was doing a lot, but it didn't make everyone happy, right? So everybody can kind of point their fingers at him now. So Kyle Dementus, he's acting commissioner, so he's not permanent, but he might be in the role for a while because it could take a while for them to find a new candidate and for confirmation to go through. Lizzy, what do we know about Kyle Dementus? He is different from other commissioners and that he doesn't have a medical or scientific degree. What do people feel about him sitting at the top of the agency? So why I've heard mostly good things that he's pretty non-controversial, stable leader, he's the leader of the food center and that center is, they've not had to deal with many controversial decisions. I think that's the aspect of the Maha movement that is pretty, you know, agreed upon, pretty bipartisan. So how he's going to handle a super difficult, being FDA commissioner is a difficult, controversial position in normal times and now there are so many headwinds. I'm not sure, but Adam, I know you also, you talked to some folks in the biotech industry about him and their impressions. What did you hear? Yeah, yeah, it made some calls this week just to kind of get a sense of like how we might act as acting FDA commissioner. You know, one biotech executive who has met with Dementus recently, he told me, the quote is great, it's the guy radiates normal. Like he basically said that he's the kind of guy and he gave him a pretty high compliment. He says, he told me that he's basically is the kind of things openly, constructively about how to solve serious problems. And he felt like he was maybe the right person at the right time to run the FDA. As you know, almost going way, way back, the FDA commissioner has usually been a physician or a scientist, right? Somebody from with a medical, with medical background. Dementus is a lawyer. He's a corporate attorney. He was a partner at Jones Day. He represented food and beverage companies. He represented Abbott Labs in a lawsuit against them related to infant formula. So it hasn't completely different background. I think that, you know, I'm curious like what you're hearing. I think that's causing a lot of problems for some people. like who don't want a lawyer running the FDA. I did talk to somebody.
a former FDA official who felt like, again, it might be at least on an acting basis, on an interim basis, a guy who is well versed in regulatory law, who will follow the rules, who will maybe try to reinstall regulatory processes at the FDA without any drama, could be a very good caretaker in the position. One of the criticisms of the FDA and her McCarrie was how much more politicization was introduced into the drug review process and given that Diemontos is not by background a doctor or scientist and has been pretty closely aligned with Trump if there's a greater risk of politicization, even no matter how normal he radiates, if that would be a concern here. I mean, whether he is in a position to be able to stand up to Trump, if Trump decides to take interest in, you know, specific psychedelic approvals or whatnot or, you know, Joe Rogan asks for something else, I don't know. I don't know. I think that's something we'll have to see how he responds to that. But it does seem like he respects career staff or it seems like he would be the type of person, especially if he's not, he has no medical background himself. He would need to have people around him that really understand clinical trials and all of these things well. And that was somewhere that McCarrie went wrong, right, where he was hiring people that mostly who he knew and who were loyal to him but had no experience at the agency. So if he elevates more of those people into positions of power that might create more of a buffer against, you know, or at least have people who have more, you know, scientific background in positions of power. So yeah, but it's, you know, it's definitely still a concern. Nothing has changed as far as the White House's interest in, you know, more closely controlling FDA scientific decisions. I have to wonder. I mean, one of the critiques of McCarrie's tenure that I've heard this week has been that he so often and his top officials were in the news were very, you know, public facing and were, you know, I mean McCarrie created a commissioners priority review voucher that he so often was a part of the story and people pointing out that sometimes like the best commissioners almost kind of like fade into the background and just do the work. And somebody like Diamantes who is being described as, I mean, quote, like, you know, of normal guy, could that be a positive? Is he the kind of person who will just let the agency run and not kind of try to be the story as it seems like McCarrie was in so many, in so many instances? Yeah, that certainly seems likely. I think that is a super fair criticism of McCarrie. Like it is, you know, it's good for the commissioner to be out there talking in the public, but he was doing it so much and he was putting himself right in the middle of every controversial, you know, was just defending every single thing. When sometimes it would have been helpful to kind of try to let things die down and maybe, you know, take a beat before responding. And yeah, it says, I mean, I think that like radiates normal quote is, yeah, that could, that could summon all up. Like he might just take, yeah, a normie approach to running the FDA too many podcasts, maybe dial down dial down the podcast. What's going to happen after you direct my favorite, my podcast that I watch all the time? We would have loved to have McCarrie on our podcast, but the guy was doing enough podcasts of his own, I guess. I personally invited him. I mean, can we go so far as to say the fact that he never appeared on the readout loud is ultimately what undid his tenure as commissioner, who's to say, who's to say? No, but let's, before we kind of jump too much into the future, like let's sum up, you McCarrie has, you know, talked publicly kind of in his resignation text, I think it was, the things that he's done as commissioner, right? He mentioned 50 reforms in initiatives in his resignation message to the president. What stands out about his tenure and what do we think actually might be durable versus what might just kind of be cast aside now that his tenure is over? Yeah, I mean, despite the tumultuous nature of his tenure, he did, he did a lot. I mean, he at least tried to do a lot. There were, yeah, so many initiatives press releases about new things that the agency was going to try. So, as far as what will stick, because a lot of these things were really just press releases and not, you know, guidances that are more likely to be codified after he's gone. But I think his initiatives to reduce animal testing that ultimately became a guidance and that seems like something that across government, across NIH, HHS, that they, that they really care about. I think that streamlining clinical trials and trying to make it easier to run early stage trials, that is something, I'm not sure how much that was making it easier to run how much that was in McCarrie and how much that is more like White House parody, but that's something I think they're going to continue to do. The plausible mechanism framework for rare disease, for, you know, bespoke personalized therapies, that also, you know, was a guidance and I think that is something that a lot of people were excited about. So I could see that lasting. Yeah. And releasing rejection letters, the CRLs, I think is also something people were excited about, but, you know, could face some legal challenges. So we'll see what happens there. So there's a handful that I think will last beyond him, but probably not all of the 50. So let's, let's move to the future. Or at least maybe to Saturday. Chelsea, you spent some time down in Louisiana recently talking to folks about, you know, Senator, Republican Senator Bill Cassidy, as we said at the top, he's facing this tough reelection campaign. The primary Saturdays got two challengers, one, one of whom is a, a Trump back candidate. Tell us about what you learned down there and we'll talk about what you ate later. Yeah, of course. Well, first to just explain why we, why we wanted to do this is Cassidy is a pretty important figure in health policy on Capitol Hill. He's the chair of the Senate Health Committee. He voted to confirm Secretary Kennedy as health secretary and that vote was very dramatic and controversial because Cassidy had expressed a lot of discomfort with Kennedy's past statements on vaccination, as since he's a doctor. He ultimately decided to do it. And with these promises made and since then many of those promises that Kennedy had allegedly made him have been broken. So the question on everybody, everybody's had is, was it worth it? Why did he do that? So me and our colleague, Daniel Payne, we went on to Louisiana and we met with his friends, allies and also his opponents, or at least one of them, Mr. Fleming, who's running for this his Senate seat as well. And one of the things we found is that Cassidy really couldn't make anybody happy with the Kennedy vote. And part of the reason is because he had cast another vote several years prior that had it angered a lot of people in his party. He had voted to indict President Trump on insurrection. One of the few Republicans to do so. Now fast forward President Trump is back in office and he has supported the Presidents. But then when it came to this Kennedy vote, he seemed very indecisive. He seemed very unsure. And a lot of the things that people told us, both friends and opponents, was that that doesn't pay off in this political landscape, that you have to be all in on Trump or not at all. And Cassidy was trying to play both sides and it didn't endear him to anybody. In Louisiana, I'm wondering, do you have a sense of whether most of the electorate would prefer someone who's all in on Trump or someone who will stand up to Trump? I mean, we met with people across the political spectrum. I think there's no denying that it's a red state. And what is important to know about this particular primary is it's the first time that they're having a closed primary in Louisiana. What that means is you have to be registered Republican to vote in this election. So Cassidy who has traditionally been more moderate and may have appealed more to Democratic voters, moderate voters, independents, he doesn't have them in this election, which is really a big problem for him because he has really alienated a lot of the hard right voters. So, Cheshire, I want to get back to the vaccine issue for a second because Cassidy, he is a physician. As you write, you know, you did a great job of profiling him in the story. Talk a lot about how he, you know, that he spent time, you know, vaccinating children in Louisiana, somebody who has supported vaccinations from a public health perspective. You know, he comes up against RFK who's obviously clearly on the other side of the issue. And he has this, you know, he is kind of the deciding vote in terms of whether or not RFK becomes a-
HHS Secretary, when you talk to voters down in Louisiana, how does that vaccine issue? How much of that come up? How much does that play and is impacting the primary? I think a lot of it, if we talk to other doctors, public health folks, they certainly felt betrayed by that vote. Mr. Hacities also, a doctor and that has always been a driving force behind his decisions that he thinks about things analytically, he thinks about patients, he thinks about the impact. So nobody denied that he didn't really think about this decision that it was important to him. But a lot of people in the public health world were pretty shocked at what he decided to do. For example, I spoke with Paul Othet. This was not Louisiana, this was over the phone, but he is a vaccine co-inventor. He has often been maligned by Kennedy for his pro-vaccination and his views. But he said that Cassidy actually called him ahead of the phone and asked him about studies, about things that Kennedy was bringing up on vaccination. And Othet walked him through the fact that there is really no link between vaccines and autism and Cassidy listened to him and then ultimately decided to vote for Kennedy anyway. Before on the Louisiana voter side, what we found was that people saw that vote for Kennedy and decided, well that's it, I'm done with Cassidy. It was more of this culmination of things with the Trump vote, with the Kennedy vote, with him just seeming so indecisive and not really sticking with one road here, either against Trump or for him. And in this race, there is a Trump-backed candidate and we have seen of late instances where Trump's endorsements had actually knocked out Republican incumbents who have kind of been viewed as disloyal to the Trump-Maga agenda. What are the stakes here if Cassidy does not win this primary? Yeah, you mentioned a Trump-backed candidate. That's Julia Letlow. She's representative now and Trump has endorsed her. What's important here is that Cassidy has always been known as a health policy wank on the hill. He's somebody that his colleagues can look to to explain really difficult health care issues. He's more of a moderate Republican when it comes to health care. So without him, and especially without him leading the health committee, I would say that it sort of removes this last check that the Trump administration has had in Congress on a health care picks because every one of the health care nominees, almost everyone, has to go through Cassidy's committee to be approved. And we've already seen that Cassidy, but also other members of his committee, have used that power to push back on some candidates, not necessarily Kennedy. But Surgeon General nominee Casey Meens, she was not advanced through Senate help in the White House eventually pulled her nomination, certainly because some senators were uncomfortable with her lack of medical experience. But if you look at President Trump's tweets about it and also Secretary Kennedy, they blame Cassidy for that. They say that he pushed back on Meens, he blocked her. So he does have the ability now to kind of wield influence over the way HHS is shaped, and he will, even if he loses the election at least through next year. But next year, if he is no longer in Congress, the White House might have more leeway in pushing through its own candidates. Yeah, so whatever the outcome of this primary election, Cassidy will still be in his seat probably when they have to confirm the next FDA commissioner. Do you have a sense of how he might approach that, whether he might stand up to policies or stances against more strongly this time and in general what people in the hell are looking for in this next commissioner? Yeah, I mean, he gave an interview with the Washington Examiner yesterday that he was not fully sure that Diamantes at least if he is the one to be commissioner had enough experience with drugs and was more focused on food, which again, is not necessarily something that Mahat people want to hear because they are really focused on food policy. So I think it remains to be seen. Again, I spoke with Holly and I've been keeping an eye on the other senators on the committee. These as far as Republicans go, they want somebody whose pro life, Cassidy has also said that. So it does remain to be seen. And also we don't actually know when a nominee will be presented to the committee. In fact, the committee also has two other nominees to consider as well the CDC nominee and the surgeon general. Cassidy has instead, which one is a priority or scheduled any hearings, they've also haven't seemed to file their paperwork, which would move them along in the process. So it's kind of a weird spot everybody's in right now. Yeah, I mean, well, I know Chelsea, you've heard Brett Jarrar, right, who's from the first Trump administration. Yes. Yeah, to name I've heard too. Yeah, but it's early. I mean, I haven't heard anything super real yet. Again, it seems likely that Diamantes will be in this role for a while given how long it takes to find someone to vet them, to make sure that they could actually get them through. I know that our colleague Daniel and I wrote about at least what the administration wants and in the next commissioner. And I think someone who can earn the trust of career staffers is among the top priorities. And also someone who will continue to back some of the reforms that McCary was seeking with speeding up drug review, working on food policy from a staff perspective. People were saying the bar is pretty low, like just listen to us and don't overrule us all the time. So we'll see. So obviously the FDA commissioner, it's a political appointee. It's a political process. I wonder whether Lizzie or Chelsea have any sense of what kind of fight we're looking at, what kind of confirmation fight we're looking at here, if and when, I mean, I guess when, because eventually there will be somebody selected to run the FDA. I think it really comes back to the committee and what they want, you know, again, Cassidy has made it clear and that he wants a pro life candidate. What that means exactly remains to be seen. I think, you know, it's, it's certainly going to be, have to be somebody who they feel like doesn't cause it's much drama in turmoil as Mr. McCary did. So I mean, if you look at the overall picture of where these nominees from HHS have been going, I think that's sort of where the direction we're heading in, right? So, you know, the surgeon general nominee, Casey Means was pulled and replaced with Nicole, Dr. Nicole Sapphire, hope I'm pronouncing her name correctly. But she's more of a mainstream, a conservative healthcare doctor. You know, she has been more pro vaccine than Casey Means has been. I think that the, and the committee has responded relatively positively to her. So I think what they're looking for is somebody who is not going to rock the boat as much as some of these past nominees. Yeah, I agree. I mean, I think, I think they want someone who's, who can manage the organization and, and be politically savvy. You know, we saw that, I mean, with Diamanta, sorry, we saw he, he, the pro life community was trying to find things that were wrong with him and he called one of the activists up to kind of quell concerns. So, you know, someone who's going to kind of do things like that, but not let these pressures get in the way of their ultimate goal of the agency to protect public health. Lastly, Chelsea, we're dying to know what did you eat when you were in Louisiana? Yeah. So, we were in both New Orleans and Baton Rouge, definitely some Cajun food. Like, oh God, I can't, I can't pronounce it. Boodayn, Boudin, Boudin. That's a Buddha. Wow, that's embarrassing for me. Yes, yes. Actually, I remember at one point, Daniel and I met with a source. We had coffee with them and they were like, oh, you have to go to this, this place, you know, it's like on the side of the highway, it's great Cajun food. So we went over there and I had amazing sausage in kind of like a case to Dia. I mean, the portions were incredible. I had, okay, I had a great shrimp poboi in New Orleans. I actually, I love shrimp poboi. It was amazing. I love a shrimp poboi. Yeah. God, I should, I honestly should have tried more. I'm not a huge adventurous eater. You know, my husband was like, oh, have frog legs. And I was like, I don't know about that. I'll pass. Yeah. But it was really great. Amazing. Well, Chelsea, Lizzie, thank you so much for joining us on this extended chat. And yeah, let's find somewhere else for us. First all to go on a reporting trip and eat some good food. Sounds great. I'm there. Agreed. Thanks guys. Thanks guys. Thank you. And that does it for another episode of the Read Out Loud. Thank you to Hyacinth and Bonato for producing this week's episode. Our senior producer is Elissa Ambrose. Our executive producer is Rick Burke.
and our theme music is by Brian Joel. And we'd love to hear from you, tell us what you like about the 6th episode, which you didn't like, and yeah, let us know if you listened to episode 401. You can do all that, if sending us an email, and read out loud, it's that news.com. And if you like what we do, leave a review or rating on Apple podcasts, or whichever platform you use to get your podcasts. See you next week. (upbeat music)
Podcast Summary
Key Points:
FDA Commissioner Marty McCarrie resigned amid pressure from vaping industry delays, anti-abortion groups, and rare disease advocates; acting replacement Kyle Diamantis, a lawyer with corporate background, takes over.
Bill Cassidy, chair of the Senate Health Committee, faces a close primary race in Louisiana that could shift Trump’s healthcare agenda.
Biogen’s tau-targeting Alzheimer’s drug (BIIB080) showed mixed mid-stage results—lowest dose worked best but study missed primary endpoint; phase 3 is planned.
Regenix Bio delayed its Duchenne muscular dystrophy gene therapy FDA application until early 2027 due to uncertainty at the agency.
Diamantis is seen as a stable, non-controversial caretaker but lacks medical/scientific background, raising concerns about politicization.
Summary:
This week’s podcast covers major upheavals in Washington D.C. impacting healthcare policy. FDA Commissioner Marty McCarrie resigned after months of speculation, driven by conflicts over flavored vape approvals, slow action on abortion drug mifepristone, and criticism from rare disease advocates. His acting replacement, Kyle Diamantis—a corporate attorney and former partner at Jones Day—is viewed as a stable, “normal” leader but lacks medical credentials, which may affect FDA scientific decisions. Meanwhile, Senator Bill Cassidy’s primary election in Louisiana could reshape Trump’s healthcare agenda.
In biotech news, Biogen reported mixed mid-stage results for its tau-targeting Alzheimer’s drug BIIB080; the lowest dose showed cognitive slowing, but the study missed its primary endpoint, and higher doses failed. The company plans to proceed to phase 3. Regenix Bio delayed its Duchenne muscular dystrophy gene therapy application until early 2027, citing FDA turmoil after McCarrie’s exit and leadership changes in the gene therapy division. The podcast also touches on the legacy of Sarepta’s gene therapy and broader regulatory uncertainty. Guests Lizzie Lawrence and Chelsea Ceruzzo discuss the political dynamics behind McCarrie’s fall and the implications of Diamantis’s appointment for drug approvals and public health.
FAQs
Kyle Diamantis, a lawyer and former corporate attorney at Jones Day, is the acting FDA commissioner after Marty McCarrie resigned.
McCarrie resigned due to multiple controversies, including his hesitance to approve flavored vapes quickly and alleged slow rolling of a study on the abortion drug mifepristone, which became political headaches for Trump.
The drug, called BIM 080, reduced tau levels in the brain and spinal fluid and slowed disease progression in early-stage Alzheimer's patients, but the study failed its primary endpoint as only the lowest dose showed efficacy.
Regenix Bio is delaying its application due to turmoil at the FDA, including leadership changes, and wants to wait for the dust to settle before filing, likely in early 2027.
Diamantis is a lawyer and former corporate attorney, unlike past commissioners who typically had medical or scientific backgrounds, which raises concerns about politicization but may offer stable leadership.
Bill Cassidy, chair of the Senate Health Committee, faces a close primary race against Trump-backed candidates, and the outcome could significantly impact Trump's healthcare agenda in the Senate.
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