The Cancer Letter’s coverage of HHS-led overhauls of foundational scientific institutions continued last week with two unrelated stories pointing to continued disarray amongst public health leadership.
This episode is available on Spotify, Apple Podcasts, and Youtube.
In this week’s In the Headlines, Claire Marie Porter, Sara Willa Ernst, and Jacquelyn Cobb, reporters with The Cancer Letter, talk about 1) HHS Secretary Robert F. Kennedy Jr. promising to reform the U.S. Preventive Services Task Force by replacing medical generalists with medical specialists, and 2) FDA rejected a drug for treating advanced melanoma, RP1 (vusolimogene oderparepvec)—for a second time—on April 10.
USPSTF is an independent panel of experts in primary care and prevention that systematically reviews the evidence of effectiveness and develops recommendations for clinical preventive services.
“What’s at stake is this group kind of quietly shapes a huge part of American healthcare,” said Claire. “Their recommendations determine what happens in your routine doctor visits, so everything from cancer screenings to preventive counseling, and under the ACA, the Affordable Care Act, they decide what insurers have to cover for free.”
Experts say Kennedy’s changes would cripple the task force’s ability to apply the principles of evidence-based medicine and undermine the scientific credibility that has made the panel a cornerstone of preventive care in the U.S.
“There are 16 members on the panel. Five are rotating out this year, I think they serve a 4-year term, and he wants to replace them with medical specialists, which is a really big shift, because since 1984, the Task Force has been intentionally built around primary care doctors and methodology experts and not disease specialists,” Claire said. “And the idea behind that is that you want people on the panel who can look at the data broadly, not folks who are deep in one lane.”
And FDA’s rejection of the melanoma drug, RP1, took the field by surprise.
“The data is really robust. So, when you look at the data and you look at some of the comments that they had in the complete response letter, a lot of people were just kind of dumbfounded,” said Sara. “I heard from one oncologist that they were flabbergasted. I talked to a patient advocate that said that there is a lot of disappointment about this rejection. This is a Melanoma Research Foundation, and at least 75 patients have reached out in the few weeks since the rejection saying, ‘Hey, I really oppose this, and I wish it went a different way.’”
The concern about FDA’s handling of the Replimune’s drug are a part of broader worries about inconsistency in the agency’s decisions (The Cancer Letter, March 13, 2026).
At least nine other companies have reported surprising regulatory decisions from the Center for Biologics Evaluation and Research in recent months, according to The Wall Street Journal.
Stories mentioned in this podcast include:
- By adding specialists to USPSTF, Kennedy would reshape the functioning and decisions of the influential health panel
- FDA’s second rejection of Replimune’s melanoma treatment stirs worry among oncologists, patients
- Benjamin Ebert, Amy Gladfelter, Stephen Liberles, and Pardis Sabeti are among new members of the National Academy of Sciences
This episode was transcribed using transcription services. It has been reviewed by our editorial staff, but the transcript may be imperfect.
The following is a transcript of this week’s In the Headlines, a weekly series on The Cancer Letter Podcast:
Jacquelyn Cobb: This week on The Cancer Letter Podcast…
Sara Willa Ernst: My story had to do with the company Replimune, and they have an advanced melanoma treatment called RP1. Essentially, they had applied for a biologics license application with the FDA, and it has been rejected not just once, but twice. So, the recent news has to do with the second rejection and some of the reactions that we’ve gotten from oncologists, scientists, and patients. I’ve heard from one oncologist that they were flabbergasted. I talked to a patient advocate that said that there is a lot of disappointment about this rejection. This is a Melanoma Research Foundation, and at least 75 patients have reached out in the few weeks since the rejection saying, “Hey, I really oppose this, and I wish it went a different way.”
Paul Goldberg: You’re listening to The Cancer Letter Podcast. The Cancer Letter is a weekly independent magazine, covering oncology since 1973. I’m your host, Paul Goldberg, editor and publisher of The Cancer Letter.
Jacquelyn Cobb: And I’m your host, Jacquelyn Cobb, associate editor of The Cancer Letter. We’ll be bringing you the latest stories, groundbreaking research, and critical conversations shaping oncology.
Paul Goldberg: So, let’s get going.
Jacquelyn Cobb: Hello, guys. We have both Sara and Claire, yes, hi, Sara! On the podcast today. And for those of you who can’t see us, it is quite the vision, I will say, because we, all three of us, have bangs—nothing weird. Just we have bangs. And so there is really just a line across our screen of three women with bangs.
Sara Willa Ernst: Oh, man. I’m trying to grow my bangs out. I don’t want these bangs right now.
Jacquelyn Cobb: Sara!
Sara Willa Ernst: I hate to say it. I have to admit it, but I’m breaking from the pack.
Claire Marie Porter: Wow.
Jacquelyn Cobb: Wow. This is crazy news. I am devastated because I think you look awesome with bangs.
Claire Marie Porter: Breaking news.
Sara Willa Ernst: Yeah. Breaking news.
Claire Marie Porter: In the headlines.
Jacquelyn Cobb: Mine are too long. Literally. In the forehead lines.
Claire Marie Porter: I mean, that’s why I wear bangs is just forehead lines. I want to just cover up my forehead lines.
Jacquelyn Cobb: Literally. You don’t need Botox!
Claire Marie Porter: No.
Jacquelyn Cobb: Yes. Yes.
Claire Marie Porter: Just keep the bangs. Keep the fringe.
Jacquelyn Cobb: Yes, exactly. Well, thank you for being here today. Very fun to have both of you on the podcast. The reason we’re doing that is that we’re going to let both of you talk about your stories last week. Both were very incredible for sort of differing reasons, and I’ll let you kind of dive in on your own. But I’ll just take us through last week’s headlines just very briefly.
Claire’s story was the cover and it was about USPSTF. I’m really not even going to try to explain that at this moment. I’m going to just make everybody wait for Claire’s explanation, but it’s a really, really huge story that just turned into something even bigger than we had anticipated. So really excited to dive into the details. Our second story was basically Sara’s version of that exact thing, where I’m not going to necessarily touch it yet, but I’ll let Sara kind of give the Spark Notes version of it and we can talk about it in more detail. And then the other story that we had last week was just something that we kind of do whenever we have it available to us. We announce the members of the National Academy of Sciences, but only the people who are sort of in our field or tangential to our field. So it’s just sort of like an oncology-focused announcement of the NAS members.
So that was our issue last week and it might sound light, but I think once we hear from Sara and Claire, it’s going to feel not so light. So I’m going to have Claire, maybe, go first. And like I said, just the Spark notes, and then we can dive in.
Claire Marie Porter: Sure. This is something we’ve been watching for about a year and a half now, but Kennedy has had his eye on overhauling the U.S. Preventive Services Task Force, which we call the USPSTF, which is a very difficult initialism for me to say. I always feel like I’m whispering like USPSTF, so I’m just going to call it the Task Force. So the Task Force. So he’s had his eye on overhauling the Task Force since kind of day 1 of his tenure at HHS. He’s called it a couple of names, things like “too woke”, “lackadaisical”, and then at a recent Senate appropriations hearing about two weeks ago, he told Senator John Barrasso that he plans to swap out some members for specialists.
So there are 16 members on the panel. Five are rotating out this year, I think they serve a 4-year term, and he wants to replace them with medical specialists, which is a really big shift, because since 1984, the Task Force has been intentionally built around primary care doctors and methodology experts and not disease specialists. And the idea behind that is that you want people on the panel who can look at the data broadly, not folks who are deep in one lane. And I guess what’s at stake is this group kind of quietly shapes a huge part of American healthcare. Their recommendations determine what happens in your routine doctor visits, so everything from cancer screenings to preventive counseling, and under the ACA, the Affordable Care Act, they decide what insurers have to cover for free.
So the stakes are high and normally the Task Force puts out 25 guidelines a year, but thanks to repeated cancellations, meeting cancellations, they put out about five last year and none, so far, this year, which means a backlog is building. So everything from guidance on alcohol screening, at-home cervical cancer tests, which were just approved by FDA a couple of weeks ago, support for perinatal depression, whether or not older adults should be taking vitamin D to prevent falls, the list goes on and they’re all stuck in limbo.
And then to layer on that, last year, the Supreme Court expanded Kennedy’s authority over the Task Force. So he can now dismiss members at will and even reject or pull their recommendations entirely. So that’s a level of control the office has never really had before over a group that was designed to stay somewhat insulated from politics. But yeah, the real flashpoint here is the reform itself, which is bringing in more specialists.
Jacquelyn Cobb: Managing and interpreting the billions of data points generated by genome sequencing and other cancer research has been a barrier to progress against cancer, but today, it’s part of the solution as more than 50 years of advances in computer processing power intersects with more than 50 years of cancer research. Learn more about Johns Hopkins Kimmel Cancer Center’s AI initiatives and how they’re helping physicians see cancer sooner and drive outcomes with unmatched speed and clarity at hopkinscancer.org/#ai.
I don’t know if this might be putting you on the spot here, but I am wondering if you could just speak a little bit more, because this is what I’ve heard sort of in the newsroom, and as you’re editing the story and talking through the story, what I’ve heard is sort of this weird counterintuitive thing that you mentioned where having specialists actually isn’t necessarily what, again, is best. Maybe that’s too subjective of a way to explain it, just because that’s very counterintuitive, and I know you explained it a little bit, but just maybe a little bit more detail would be helpful.
Claire Marie Porter: Yeah. Sure. And it is counterintuitive, because when Kennedy said that, which, I don’t know if it’s the first time he said it’s the first time that we picked up on it, and Paul was the one who flagged it and he was like, “That’s not normal. Specialists have never been on the Task Force.” And so I did some digging and talked to some really helpful voices, including former members of the USPSTF.
So on one hand, the story goes that specialists have been arguing for decades that they deserve a vote. Oncologists, radiologists, urologists especially, they’ve all said, “Hey, we’re the ones who are actually dealing with these diseases.” And they are not shot out to be fair. The Task Force does take their input very seriously. They’re just not voting members, and that’s intentional because specialists, by definition, have a narrower focus. So a breast oncologist, for example, might lean more toward aggressive screening, which is great for catching disease early, but it could also lead to overdiagnosis or overtreatment or unnecessary treatment across broader populations.
So the Task Force, instead, they lean heavily on generalists and data experts, people whose job it is to ask what’s best for everyone. And there is evidence, David Ransohoff told me that there’s evidence of bias when you bring in specialists, but since ACA, I guess, was linked to the Task Force recommendations in 2011, I think, don’t quote me on that, there has been more pressure for them to include specialists on the panel, more lobbying efforts, and experts suspect that Kennedy is hearing from a lot of lobbyists, and that is why he is pushing for specialists. So yeah, does that answer your question?
Jacquelyn Cobb: Yeah, yeah. I think you were also alluding to this with how you were explaining it, but just how far the reach is of this. It seems so bureaucratic and so USPSTF, it seems so insulated from maybe just the average person or the average American who’s just going about their daily life necessarily, but it really does have very strong impacts. I’m thinking about, obviously, cervical cancer screening, multi-cancer detection screening. All of these things are running through my head.
But even more so, I think I’m thinking about the alcohol guideline story, and I’m probably going to butcher it because it’s now been a few weeks, but the idea that, within oncology, and actually, it’s been a year since I think I wrote this part of the story, but within oncology, alcohol may have these sorts of negative impacts, but the mortality impact might look the opposite. And I remember, I think it was Don Berry, I want to say, I’m going to have to check that, but he said something like, “The last thing you want is someone dying younger than they would have, but on their deathbed, what they say is, ‘See mom, I didn’t die of cancer’, but they’re dying earlier than they would have.”
So it’s like there’s definitely, I think, something. Even us being so oncology focused, I think that we could probably have some blind spots when just thinking about this.
Claire Marie Porter: Definitely.
Jacquelyn Cobb: Yeah, I thought it was just interesting to kind of… Yeah, you would think that you would want specialists, but was it Paul? I don’t want to out him, but was it Paul who said that having a specialty is almost a form of bias in this case because you care? You see only these patients, and so it’s going to impact how you see disease and risk.
Claire Marie Porter: Right, right, right. Of course. I mean, no one could fault anyone for wanting what’s best for their population, and that’s what they see and live every day. But yeah, it limits your perspective.
And something I forgot to mention is that a comparison that’s being made because we’ve watched what happened with ACIP, CDC’s immunization panel where all of those members were forcibly retired by Kennedy and then replaced by his handpicked replacement members and no one listens to ACIP anymore. The multiple sources that everyone’s ignoring ACIP and they are turning instead to other more trustworthy guidelines. However, with the Task Force, that can’t happen. Nothing can replace the void of the Task Force. It does cover, like you were saying, preventive services from birth to death. The scope is massive and there is nothing that can just easily step up and take the place of that. So that’s what makes this a bit more of a very, very pivotal moment when it comes to preventive medicine in the US. The foundation of preventative medicine in the US.
Jacquelyn Cobb: What a way to wrap up that conversation. Just like, “Oh, just that.”
Claire Marie Porter: On that note…
Jacquelyn Cobb: On that note, Sara, will you distract us from the horrors, the general horrors?
Sara Willa Ernst: Or, maybe I can add a couple more horrors.
Jacquelyn Cobb: Cool, yeah. There you go.
Sara Willa Ernst: My story had to do with the company Replimune, and they have an advanced melanoma treatment called RP1. Essentially, they had applied for a biologics license application with the FDA, and it has been rejected not just once, but twice. So the recent news has to do with the second rejection and some of the reactions that we’ve gotten from oncologists, scientists, and patients. I’ve heard from one oncologist that they were flabbergasted. I talked to a patient advocate that said that there is a lot of disappointment about this rejection. This is a Melanoma Research Foundation, and at least 75 patients have reached out in the few weeks since the rejection saying, “Hey, I really oppose this, and I wish it went a different way.”
And this all kind of ties into greater questions about what’s going on at FDA in terms of leadership. There is one Wall Street Journal article, if I can pull it up right now, that said that at least nine other companies have reported surprising regulatory decisions from the Center for Biologic Evaluations and Research. So there’s a question about whether this is part of a greater trend of what’s happening in FDA where there’s this just lack of predictability, kind of the rug being pulled under from them, the moving of the goalpost after different communications, and how, as a drug company, do we really get a drug through?
Jacquelyn Cobb: Yeah, absolutely. I wonder, Sara Willa Ernst, if you, and again, not to put you on the spot necessarily, but I do wonder about this sort of second rejection, because I covered the Atara Bio story, and that was sort of like a parallel story, a similar situation, with a different company who expected an approval and, like you said, had the rug ripped out from under them. And so I’m just wondering, because my coverage of that story, they are, I think, planning on resubmitting, and I assume that’s what happened here with Replimune, that they resubmitted after a surprising rejection. And I’m just wondering, did they expect to get the approval this time around? I guess I’m wondering about that sort of dynamic. Was the second rejection different?
Sara Willa Ernst: I haven’t talked specifically to anybody at the company, but from the sources that I’ve talked to in the patient advocacy world and the scientific oncology world, it seems like it was surprising, not so much in terms of, maybe, the political atmosphere or these questions around really what’s going on behind the curtain, but more so in terms of just the data. The data is really robust, and so when you look at the data and you look at some of the comments that they had in the complete response letter, a lot of people were just kind of dumbfounded.
Jacquelyn Cobb: Yeah. Yeah, it just didn’t make a lot of sense. That’s very odd. Well, yeah, I know that that’s definitely been sort of a conversation, like I said, in the rare disease space, but also just for any drug developer, having sort of that stability or you’re able to expect something from FDA, especially as you invest billions or millions of dollars into drug development, especially clinical trials.
Sara Willa Ernst: Yeah. And the company, Replimune, is kind of in hot water at this moment. They had laid off at least 200 people from the news stories that I read since the second rejection, and as you can expect, the stock price has also totally plummeted. It has gone from $850 in the beginning of April to $246, and this was from May 1st. That’s, like, a fourfold decrease almost. So there’s a lot of questions about what’s going to happen to the company, and then as a result, what’s going to happen to the drug. Is Replimune going to pull through? Is another drug sponsor going to step up? Will we not have access? Will the oncology community not have access to this drug because of the FDA rejection? It’s just unclear at this moment.
Jacquelyn Cobb: That’s terrible. And like you said, with the patients reaching out for it, that’s especially biting. It doesn’t feel good.
Sara Willa Ernst: Yeah.
Jacquelyn Cobb: Well, we’ll have to keep a track of it. Is there anything that we missed with that story, Sara Willa Ernst, before I wrap up? I’m sorry, I’m not very… I need to go read your story, is the main thing. I’m very curious about it.
Claire Marie Porter: She reported and wrote that story in, like, 2 hours on Friday.
Jacquelyn Cobb: 2 Hours!
Claire Marie Porter: Maybe less, maybe a little bit more, but I was like, “How did you do that?” It was amazing.
Sara Willa Ernst: I don’t know. I just sent a barrage of emails and prayed to the gods.
Claire Marie Porter: Yeah. We were like, “We need a second story.” And no one knew what to do. It was kind of a crisis moment. And so Sara is an angel. She’s a hero.
Sara Willa Ernst: Well, this is what all the beautiful breaking news reporters experience on a daily basis, and I am not jealous of them. So God bless you guys.
Jacquelyn Cobb: Breaking news reporters, we commend you.
Claire Marie Porter: Yes.
Jacquelyn Cobb: We could never do it.
Claire Marie Porter: I’m not cut out for that lifestyle.
Jacquelyn Cobb: On the occasional time, we know that. Well, thank you guys so much for joining me. It’s a little bit of a short and sweet podcast this week, but very dense, very, very interesting. And all of the listeners, please go read the stories because, like I said, definitely a lot more in there to explore. So thank you and see you next week.
Thank you for joining us on The Cancer Letter podcast, where we explore the stories shaping the future of oncology. For more in depth reporting and analysis, visit us at cancerletter.com. With over 200 site license subscriptions, you may already have access through your workplace. If you found this episode valuable, don’t forget to subscribe, rate, and share. Together, we’ll keep the conversation going.
Paul Goldberg: Until next time, stay informed, stay engaged, and thank you for listening.
