NIH has announced it will stop issuing funding opportunities solely dedicated to animal models, but has not published any formal guidance related to the announcement, and researchers are unclear on when or whether further policy materials are to be expected.
This episode is available on Spotify and Apple Podcasts.
In this episode of The Cancer Letter Podcast, Paul Goldberg, publisher of The Cancer Letter, and Claire Marie Porter, reporter, talk about cancer policy, politics, and NIH’s new announcement on moving away from animal testing.
The announcement, made by Acting NIH Deputy Director for Program Coordination, Planning, and Strategic Initiatives, Nicole Kleinstreuer, also said that all new NIH-funded project proposals must mention non-animal testing methods.
“From what I’ve heard, on and off record, from the sources that I’ve reached out to—is that we’re nowhere near,” Claire said of moving away from animal testing.” Everyone wants to save animals, and have less animal testing, that would be great. There’s a lot of measures in place that are already focused on reducing those things.”
The statement was made on July 7 at the very first joint meeting of NIH and FDA, an event called Workshop on Reducing Animal Testing, to discuss the prioritization of the replacement of animals in research and testing.
“But AI is not ready. Organs on a chip are not ready, from my understanding, to take the place of those animal models,” Claire said. “They can complement the animal models, but they cannot replace them.
“It’s just interesting whether there has been really sufficient open discussion of this with the real scientists from the outside highest level,” Paul said.
Stories mentioned this week include:
- The Directors: Mark Evers and Steven Libutti on riding out the tempest—and maintaining research momentum. As oncology braces for funding, Medicaid cuts, these two directors tell young investigators not to panic
- ODAC nixes GSK’s Blenrep myeloma regimens, citing ocular toxicity, dosing, applicability to U.S. population
- Jeff Sorenson: Imaging’s ride to the bottom in clinical trials—and why it matters now
- NIH says it’s moving away from animal-based models
- Trump threatens tariffs on Big Pharma by Aug. 1
- CMS publishes Medicare physician fee schedule proposal
- CMS proposes policy to move away from hospital-based care
- Enrollment begins in NCI’s Vanguard study focused on defining benefits of MCD tests
- Ohio State launches pancreatic cancer trial via telehealth
This episode was transcribed using transcription services. It has been reviewed by our editorial staff, but the transcript may be imperfect.
Jacquelyn Cobb: This week on The Cancer Letter Podcast.
Claire Marie Porter: All new NIH-funded projects, henceforth must mention non-animal testing methods, but what that actually means, or if there’s pending guidelines, we’re not sure.
Paul Goldberg: That should be very interesting. Where’s the science on this? I know you’re fairly early in the reporting, but what’s your sense of where the science is?
Claire Marie Porter: From what I’ve heard on and off record from the sources that I’ve reached out to is that we’re nowhere near the… Everyone wants to save animals and have less animal testing. And that would be great. And I think there’s a lot of measures in place that are already focused on reducing those things, those testing methods. But AI is not ready. Organs on a chip are not ready, from my understanding, to take the place of those animal models. They can complement the animal models, but they cannot replace them.
Paul Goldberg: You are 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: Let’s get going.
Claire Marie Porter: Hey Paul, how are you?
Paul Goldberg: Hi, Claire. How are you?
Claire Marie Porter: I’m good. I’m fine. How are you? You’re in Vermont?
Paul Goldberg: I am. In fact, I apologize if there’s barking because we have this bear wondering about, and the dogs seem to want to play with him or something, which he would not appreciate.
Claire Marie Porter: I keep hearing you about this bear. It sounds like a part of the family at this point.
Paul Goldberg: We have a lot of bears here. It’s black bears. They look like dogs but they’re much larger.
Claire Marie Porter: You saw some babies around, or are they all of the above?
Paul Goldberg: There’s more and more of them. It’s great. It’s fantastic.
Claire Marie Porter: It sounds adorable. What was that?
Paul Goldberg: I said I wouldn’t come too close to him.
Claire Marie Porter: No, but they’re the ones that you can… My survivor knowledge, it’s mostly just from movies, but can’t you just clap your hands or bang on dishes to get rid of black bears? They’re pretty easily spooked.
Paul Goldberg: They don’t seem to be spooked by the dogs. They’re not looking for confrontations.
Claire Marie Porter: Just snacks.
Paul Goldberg: Snacks.
Claire Marie Porter: Relatable, honestly.
Paul Goldberg: Things in the car, they can go inside the car. They can open doors.
Claire Marie Porter: Ridiculous. They’re getting smarter and smarter.
Paul Goldberg: Unlike us.
Claire Marie Porter: Not like us. Speak for yourself.
Paul Goldberg: Unlike us. We as humans are not getting smarter and smarter. In fact, let’s talk about last week’s events.
Claire Marie Porter: Jacquelyn’s off grid in Peru, I’m going to give the rundown this week and then we can launch into what Paul is teasing. Story one was the directors. Mark Evers, director of University of Kentucky, Markey Cancer Center, and Steven Libutti, the William N. Haight, director of Rutgers Cancer Institute were interviewed by Paul. They spoke on keeping endurance and research momentum and keeping faith in oncology as the field braces for funding cuts and Medicaid cuts. You can check that out on our podcast channels. Jacquelyn, with support from Sarah Waller-Earns covered ODAC last week. If you read TCL, we covered those.
Claire Marie Porter: The FDA Oncologic Drugs Advisory Committee on July 17th recommended against approval of a blend rep based regimen for the treatment of relapsed or refractory multiple myeloma, which is a mouthful. We had a very interesting guest editorial written by Jeff Sorensen, the CEO and co-founder of UNU on how imaging remains a bottleneck in clinical trials. And in our cancer policy roundup section, we had some interesting bits. NIH has made a statement saying that it’s moving away from animal-based models, which is something we’ll talk more about in this podcast today. Trump is threatening tariffs on pharmaceuticals by August 1st, and then CMS proposed some policies last week. One is that the Medicare physician fee schedule proposal as well as a proposal for a policy to move away from hospital-based care. I think we’re going to jump around a bit today and maybe drop some teasers for future stories that we’re working on, but Paul has some more, I guess, urgent news.
Paul Goldberg: It’s interesting. Both news items have to do with FDA. One of them is there is now a new CDER director, excuse me. CDER director, CDER Center for Drugs Evaluation and Research. George Tidmarsh, he is a pediatric pediatrician and oncologist as well, and has also done work in inflammation. I actually do not know if he’s an oncologist. He was an adjunct professor at Stanford and an entrepreneur who started a couple of companies.
Paul Goldberg: I’ve had a few minutes to look at what he has done in the past and will look a lot harder as the day goes on. He has criticized J&J for talc and he has criticized the establishment’s way of thinking about talc being safe. That should be very interesting. And I think he’s also had some opinions on COVID, but the part that’s more ready to be talked about is Laura Loomer, who is a right-wing activist, provocateur, has attacked the CBER director, who’s also the Chief Medical and Scientific Officer of FDA, Vinay Prasad, accusing him of being a left-wing saboteur, which is interesting. I never really thought of him as a left-wing saboteur or right-wing saboteur, and I’ve followed him fairly closely. Vinay Prasad is very interesting character. Definitely an iconoclast, but saboteur? No.
Claire Marie Porter: I didn’t know much about Vinay until really digging into his substack a month or so ago when he was tapped for this position. And just really a very, very public presence, social media, big old substack following. And I think something that is particularly interesting as a journalist with this administration is that a lot of these folks tend to air their grievances very publicly on social media. We get to watch it play-out. And that was a fun story to write. I think we called him a cyber iconoclast, which is very much who he continues to be.
Paul Goldberg: That’s great.
Claire Marie Porter: Good for him.
Paul Goldberg: What’s really interesting is that a lot of what happens in scientific debates has nothing to do with right or left wing. It just doesn’t work that way. And he has, on occasion, stated that he was, according to this piece, I’ve never really given any thought to whether he’s right wing, left wing, middle wing, no wing, never even crossed my mind to think about it.
Claire Marie Porter: It’s like he’s genre bending, which I feel like a lot of HHS folks are genre bending.
Paul Goldberg: He’s done that. It’s not genre bending, it’s another dimension. Science is about science. When you know stuff you don’t know stuff. He has said apparently, according to this piece in Laura Loomer’s newsletter or whatever the heck it is, she quotes as him saying that he is a Bernie Sanders supporter. Okay, so he is, does that disqualify him from being a CBER director or does that disqualify him from being the chief scientific officer of FDA? Heck no.
Paul Goldberg: And by the way, what’s really interesting, you could probably say some similar things about RFK Jr. I don’t think of him as a Trumpist, really. He’s ma-ha.
Claire Marie Porter: As a loyalist.
Paul Goldberg: I don’t think of him in political terms. You can go from left to right, right to left. Public health doesn’t work that way. It can. It’s not very good when it does usually, but what do I know? But it will be very interesting because Laura Loomer is very influential and she has ruined careers. It will be very interesting to see if there is any reaction. If I may, as an American citizen say, I hope there is no reaction.
Claire Marie Porter: Yeah.
Paul Goldberg: Not a friend of Vinay Prasad. My God, we’ve certainly been critiquing much of what he said before this, but my God, I hope they leave him alone as a result of this attack.
Claire Marie Porter: We’ll report that out a little bit for next week. I think it’ll definitely make it into our cancer policy section.
Paul Goldberg: It meets that bar.
Claire Marie Porter: It does meet that bar, indeed exceeds that bar in some ways.
Claire Marie Porter: We’ll be right back after a quick word from our sponsors.
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Claire Marie Porter: There were some things from our clinical roundup section and actually a couple of stories that we published this past Friday that will become larger stories next week, which would be interesting to touch on the two trials. I know the one trial which we announced in our clinical roundup section that is led by medical oncologist, Sameek Roychowdhury from Ohio State. First, telemedicine pancreatic clinical trials have launched, and I won’t be reporting this for next week, but it’s a story. I spoke with him a couple of months, and it’s a story that’s unwinding that I’m reporting, and I hope to publish with us at some point here.
Claire Marie Porter: But it’s the first telehealth trial that offers therapy for metastatic cancer. And the goal is to make this change of standard of care and make this type of approach more widely available and known using, basically, as long as you have access to the internet, it doesn’t really matter where you are, your drugs will be delivered to you. The concept is that this could be a silver bullet for rare cancers that wouldn’t normally be able to get into clinical trials because of low enrollment numbers and because of geography. That’s the one that I’m excited about that I’m reporting on. And then there was also the NCI-sponsored trial, the Vanguard study, which we will be writing about next week, which I think you know more about than I do.
Paul Goldberg: It’s exciting to see NCI actually start a trial, and it’s exciting to see them expand to an area that’s actually very relevant, which is measuring which of the multi-cancer detection trials, MCDs, work, and how they work and whether they work. There’s a lot of skepticism on this in every way you go, it’ll be very interesting to see how that gets off the ground. But this is the first phase of the Vanguard trial, which is basically trying to determine whether it is feasible to do this trial. And they’re testing two modalities versus observation arm. We’ll do a lot more, because I spoke with the PI of the trial, Scott Ramsey, we didn’t really get it in last week into the issue because it’s a great time to be a journalist. We’re catching up, we’re keeping up with it, but sometimes we have to go back a little bit and clean up all of the things that we’ve missed or not missed, but just glossed over just because time is short.
Claire Marie Porter: And another piece of that, good segue, which I love, is this NIH announcement from last week that we started reporting on and then realized, “Oh wait, this is actually a really huge story. Let’s give it its due diligence.” And that’s the NIH announcement that they will no longer be issuing NOFOs or notices of funding opportunities that exclusively support animal models. And the announcement came out last week. It was made by NIH Acting Deputy Director for Program Coordination Planning and Strategic Initiatives, Nicole Kleinstreuer. She said that all new NIH funded projects, henceforth must mention non-animal methods, but what that actually means, or if there’s pending guidelines, we’re not sure.
Paul Goldberg: That should be very interesting. Where’s the science on this? I know you’re fairly early in the reporting, but what’s your sense of where the science is?
Claire Marie Porter: From what I’ve heard on and off record from the sources that I’ve reached out to is that we’re nowhere near the… Everyone wants to save animals and have less animal testing. And that would be great. And I think there’s a lot of measures in place that are already focused on reducing those things, those testing methods. But AI is not ready. Organs on a chip are not ready, from my understanding, to take the place of those animal models. They can compliment the animal models, but they cannot replace them. It’s too soon.
Paul Goldberg: It’s just interesting whether there has been really sufficient open discussion of this with the real scientists from the outside highest level as opposed to a work should you do? What’s next? What’s the process? It’d be very interesting to find out. I’m looking forward to seeing what you find out.
Claire Marie Porter: Me too. I think my biggest question that as like I want to figure out some answers, some semblance of an answer to is why this administration is so interested in animals? McCarrie came in, I think it was his very first sit down interview, or maybe it was Bhattacharya’s first sit down interview. And then his first talk before the FDA, he mentioned animals and saving the animals and how God didn’t put animals on this earth to be used in this way was a direct quote, I think, or close to a direct quote.
Claire Marie Porter: And my initial response was, “Why is this political posturing? Is it all NIH has called it a political wedge?” But maybe none of that’s true. Maybe all of that’s true and maybe it doesn’t discount maybe the spirit behind it. I love animals. I would love to see beagles out of the labs, but it’s more nuanced than that as most things are when it comes to science and politics. But I don’t want to give it too much away. I have some more thoughts, but should read our story next week, come back around.
Paul Goldberg: Unnecessary animal testing is definitely a bad idea, but if it’s necessary, I don’t know. There are ethicists who work on this and I’m not one of them.
Claire Marie Porter: I suspect it’ll be a contentious story or it’ll be a doozy is what I mean.
Paul Goldberg: It will be important to capture the discussion as it’s taking place right now.
Claire Marie Porter: In real time. Exactly.
Paul Goldberg: And to talk about the process and to talk about to register all of their opinion. We’ve got a busy week ahead of us, don’t we?
Claire Marie Porter: We do, yes. What else are you working on? We talked about maybe the summer’s winding down here. We’re coming up on our editorial calendar break. I know I have some stories that I’ve been reporting for a while, but what’s coming up?
Paul Goldberg: I’m looking forward to doing a story about the patient portal that’s being built right now. It’s being done by Peter Garrett, formerly of the National Cancer Institute and his organization, which is called Pacer. I’m looking forward to that. And I’m also working on putting together the reading issue, the summer reading issue, and really looking forward to finding out what’s going to happen with an appointment of an NCI director. And then I’m really looking forward to getting a little bit more than three weeks off, I think four weeks off to write my novel. I need to move it forward. I haven’t been able to work on it very much at all since the start of the Trump administration.
Claire Marie Porter: I wonder why. That’s very exciting. I didn’t know that’s what your plan was, but I guess Vermont is probably a good place to get into that writer space.
Paul Goldberg: Going to really hide out. I’ve got a box of books to read, and then actually, I’ve even really done all of my research and I’m going to sit down and actually, I have about half of it written. I just want to write another quarter or so really fast because the research is done.
Claire Marie Porter: That’s awesome. That’s very exciting.
Paul Goldberg: Thanks. I’m looking forward to it, but it is a great time to be a journalist.
Claire Marie Porter: It sure is. I will not be writing during the break. I will be traveling and doing a lot of crossword puzzles. That’s my goal.
Paul Goldberg: Those are good.
Claire Marie Porter: Thanks for talking, Paul. It’s always a pleasure.
Paul Goldberg: Always is. And again, it’s a great time to be a journalist.
Claire Marie Porter: How did I know you’re going to say that?
Paul Goldberg: Or should we just say it together? 1, 2, 3, with a delay. This is a great time… It’s pathetic.
Claire Marie Porter: It’s too cringey, cut that out. It’s too cringey.
Jacquelyn Cobb: 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.
