In this week’s episode of The Cancer Letter Podcast, Paul Goldberg, editor and publisher, and Sara Willa Ernst, reporter, go on a trip into the world of federal health policy surrounding psychedelic medicine.
This episode is available on Spotify, Apple Podcast, and Youtube.
In April, FDA issued National Priority Vouchers to three companies conducting clinical trials of psilocybin for treatment-resistant depression and major depressive disorder, and methylone for PTSD, as well as an IND to study ibogaine for treatment of alcohol use disorder. This came after the president issued an executive order vowing to accelerate drug approvals of psychedelic drugs.
“One thing that they seem to want to do is reverse Nixon’s War on Drugs, which stopped all of the psychedelic drugs research in its tracks in the ’70s,” Paul said.
Some oncologists are not opposed to this reversal, particularly as clinical trials evaluating psilocybin as a treatment for cancer-related anxiety, depression, demoralization, fear of recurrence, and other psychological conditions have been ongoing since 2008. But the story behind the policy change is cause for concern.
At a press conference in the Oval Office, President Donald Trump sat next to Joe Rogan, comedian and host of “The Joe Rogan Experience” podcast. Just two and half weeks before, Rogan published a two-hour long interview on ibogaine.
Rogan texted Trump about the psychadelic’s promise as a treatment for drug addiction, brain trauma, and cognitive decline.
“The text message came back: ‘Sounds great, do you want FDA approval?’ It was literally that quick,” Rogan said at a subsequent press conference with Trump in the Oval Office.
“This is a very unscientific way to roll back the scientific kibosh,” Paul said.
The policy change didn’t appear to come from scientific consensus by an expert panel brought together by FDA or NIH.
“When the President of the United States can text you saying, ‘Would you like an FDA approval?’ I worry about prescribing, but especially off label,” said Paul, editor and publisher of The Cancer Letter. “This thing is not approved, by the way, to give credit to FDA right now.”
Stories mentioned in this podcast include:
- Is psilocybin heading to a cancer clinic near you?
- What NHS-Galleri taught us—and what it didn’t
- The NHS-Galleri trial has and will continue to provide critical insights to refine future MCED studies
- FDA clears a way for dramatic reduction in animal toxicology studies in cancer
- Proposed OMB rule aims at the heart of the U.S. research enterprise—and scientists are fighting back
Jacquelyn Cobb: This week on the Cancer Letter Podcast.
Paul Goldberg: A podcaster sends a text to the President of the United States and the other bit of it, which we probably should mention is the response that Joe Rogan got to the text. What was the response?
Sara Willa Ernst: This is a quote. Joe Rogan said “the text came back,” and this is from Donald Trump, “‘Sounds great. Do you want FDA approval?’” And then Joe Rogan says, “It was literally that quick.”
Paul Goldberg: Now, when the President of the United States can text you saying, “Would you like an FDA approval?” I worry about prescribing, but especially off label. This thing is not approved, by the way, to give credit to FDA right now.
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.
Sara Willa Ernst: Hi, Paul.
Paul Goldberg: Hi, Sara. How are you?
Sara Willa Ernst: Good. Well, I’m hosting today and just to cue everybody else in, Jacquelyn Cobb is not on the pod. She is on the job, but she is not on the pod today. It is me, Sara Willa Ernst, and I’m here with Paul Goldberg. And the reason we’re here together is because I wrote the cover story this week and we thought it would be a really good idea to have a reporter-editor conversation. Paul edited the story and went through multiple iterations and I think the final version really is the one that shined the most.
But funny enough, the editing process was kind of chaotic because I lost my voice last week. I don’t know if people could hear the smokiness of my voice right now.
Paul Goldberg: But you’re a life-long non-smoker presumably.
Sara Willa Ernst: Yes. Well, maybe a couple here or there, but I’m not going to be telling a bunch of researchers that.
Paul Goldberg: We’re not going to talk about that. And they don’t have to be tobacco.
Sara Willa Ernst: Right. But yeah, I lost my voice. So trying to do an edit over Zoom is incredibly difficult when one person doesn’t have a voice. Paul was talking to me. I was furiously sending messages over Slack and it was very chaotic, but I think we came to an end result that I’m very happy with.
Paul Goldberg: It was a fun story to edit.
Sara Willa Ernst: Yeah. So why don’t we go through the stories real quick. I mean, the cover story actually is particularly fun because it’s about psilocybin and psychedelic medicine and certain changes at the FDA that are trying to accelerate some of this research and some of the reviews and approvals for these drugs. And specifically, what does that have to do with cancer patients? Could this potentially be a psychological treatment for cancer patients? And we’re going to dig into that, but I’m going to just run through the rest of the headlines.
We had two very interesting guest editorials. Jacquelyn and I, we did some coverage back in March around some of the results around the NHS-Galleri trial when it comes to the GRAIL multi-cancer detection test. We got the press release out, we got some of the high level results, but a lot of our sources were telling us, “Hey, let’s just see what’s underneath the iceberg. Let’s see what the full results are.” And at the end of May, early June, the full results came out at ASCO.
So we decided to reach out to multiple sources and say, “What do you make of this? How do you make sense of this?” So we have one guest editorial from some of the folks working on the Vanguard trial at NCI and we have another guest editorial from some of the folks that are part of something called the FOCUS Consortium. And so 12 people part of the FOCUS Consortium wrote a guest editorial. These are also people working on clinical trials related to multi-cancer detection tests, but I think a lot of the people have more clinical experiences working directly with patients that are taking these tests and have that perspective in the guest editorial.
Beyond that, Claire Marie Porter wrote another story related to FDA and regulatory news. This one had to do with FDA creating a pathway or clearing a way for a dramatic reduction in animal toxicology studies in cancer, and that has to do with proposed guidance that came out at FDA.
And then we have our last story, which is also proposed guidance and the rulemaking process coming up, and that had to do with some of the proposed rules published by the White House Office of Management and Budget and what that has to do with how federally funded research is structured and what will be acceptable and unacceptable.
Some of the folks at Stand Up for Science held a press conference and they’re speaking out and they’re not in favor of these proposed rules. There were scientists at the meetings, elected officials, former NIH administrators, and they basically went through the entire 400-page document and they said what is wrong with it, and the story digs into that.
In order to learn more about that story, you’re going to have to read it, but we can talk about the cover story on today’s podcast.
Paul, when I came to you with the psilocybin idea, or when I came to you with my first draft, were you confused or you’re like, “Oh, this makes complete sense why this would be related to cancer patients?”
Paul Goldberg: I mean, when you’re dealing with issues such as pain and existential issues that cancer patients face, you kind of have to keep an open mind. I was perfectly open to the idea of doing that story, of course. Who am I to judge?
I was a little miffed about the way it came about, which actually is a part of the story, which is kind of like in civics classes, there is a chapter usually in a book that says how a bill becomes a law and it has nothing to do with how a bill becomes a law. This is how science is done. This is not how science is usually done, which is kind of an interesting part of the story for me. Why don’t we talk about how this came about?
Sara Willa Ernst: Right. So in April, the White House put out an executive order basically directing FDA to take a look at psychedelic medicine and it resulted in three national priority vouchers, two for psilocybin and then one for methylone, which is a stimulant, and how it came about… I mean, there was a press conference around it and Donald Trump wasn’t the only person at the press conference. I think for those of us that listen to podcasts, there was another familiar face, which was Joe Rogan. Joe Rogan of the Joe Rogan Experience, one of the top podcasts on the charts right now, and he was a pretty crucial part to this executive order happening in the first place. Basically, during the press conference, he said, “Yeah, I just shot Donald Trump a text and he said, ‘Great, let’s do it.'”
I mean, they made it seem like it was as simple as that, but the influence to change federal policy wasn’t necessarily coming from an FDA expert panel or from scientific consensus among different scientific institutions. It was coming from a guy who had a couple guests on his podcast and they talked about particularly ibogaine and its impact on potentially alcoholism or opioid use disorder, and it seems like there’s a pretty clear line between that podcast and then federal policy changing as a result of the executive order. So that’s a little bit… Yeah.
Paul Goldberg: I’m back to that parallel with how a bill becomes a law and how it never happens that way. But one thing that they do seem to want to reverse and probably have reversed is something that comes from Nixon’s War on Drugs, which was what stopped all of the psychedelic drugs research in its tracks in the ’70s. So in a way, this is a very unscientific way to roll back the scientific kibosh that was put on this.
Sara Willa Ernst: And this is something… So I got to interview three clinical trialists, actually scientists working specifically with cancer patients and seeing whether or not psilocybin could be an effective treatment for anxiety, depression, demoralization, end of life anxiety, and there was concern amongst those specific sources and that the full extent of it can be read in the story, but there was definitely a lot of eyebrow-raising about how this specific executive order and the national priority vouchers came to be.
And there was concern about whether or not the respect or the incorporation of scientific institutions in the process of developing federal policy is being undercut in a lot of ways under this particular administration.
Is your head spinning from the pace of health policy news? Are you struggling to figure out what it all means for the cancer community? Find the resources you need on ASCO in Action, the online information hub from the American Society of Clinical Oncology and the Association for Clinical Oncology. ASCO in Action has news and analysis on issues like federal research funding, prior authorization, and reimbursement, and visitors can find ways to get involved in advocacy efforts. Visit asco.org/ASCOaction today.
Paul Goldberg: Which actually, maybe we should now talk about patients because that’s a huge piece of the story and that’s what made the story worth telling. You’ve spoken with a patient.
Sara Willa Ernst: Yeah. Her name is Anne Hamilton and she is the founder of the Survivorship Collective. I mean, I am so grateful to speak to her. I mean, we probably had two or three conversations and it took place over multiple hours in which she shared with me her own experiences being a cancer survivor, what that did to her mental health, and how psilocybin was a very, very healing experience for her. And it was actually what kind of turned things around for her. At least that’s what she attributes.
Her advocacy group actually organizes psilocybin trips for cancer survivors to go to Oregon, one of the few states where it’s legalized on the state level. So there’s three states, Oregon, Colorado, and later this year, New Mexico, where psilocybin is legal and folks are using it in the clinic.
But going back to Anne’s experience, I mean, she talked about how she became very dissociated from her own body throughout the experience of being a cancer patient.
And obviously a big part of it is you’re kind of forced into this situation. You’re forced into doing 30 rounds of radiation. You’re forced into getting a double mastectomy. This is the way in which you’re surviving, but part of it was also some of the bedside care that she experienced, just people… She mentioned specifically radiation technicians just kind of moving her around like a slab of meat and not really seeing her as a human being and getting to know her name or asking her, “Is this okay or is this not okay?” And the way that she psychologically survived through those experiences was just to disconnect, was to dissociate from her body where her mind was over here and her body was over here and they were not connected.
And once you kind of go through the acute period of, “I need to survive, I need to survive,” and you enter into survivorship and you try to live a life maybe with more of an abundance mentality, it doesn’t snap back in immediately. That dissociation still exists and that creeps into people’s interpersonal relationships. In some ways, she actually compared the experience of being a cancer survivor to being a sexual assault survivor in that you’re very dissociated with your body, and yeah, that has impacts beyond just that period of time. There are ripple effects that go beyond that.
Paul Goldberg: I don’t know how you would even design the studies to see if psychedelic drugs help address this disassociation, but that is also where you have to trust scientists and clinical trialists to make the right decisions. That’s my… I know, which makes me very uneasy about OMB, for example, and its idea of how research should be done. Leave it to the scientists.
Sara Willa Ernst: Yeah. I can say anecdotally, this is not science, this is one story, but with Anne Hamilton, she just mentioned that once she embarked on her psilocybin experience, she was able to grieve those experiences. She was able to kind of open up and touch emotions that were otherwise locked up and calcified. And as a result, she mentioned having a hallucination in which she got to accept some of her experiences for what they were.
There’s more details to this story, but I kind of don’t want to tell the whole story on the podcast. I’d love for people to read it in its depth and nuance in the actual story. So I think that’s all I’ll say for now.
Paul Goldberg: Well, it will be very interesting to see what the next chapter of this is going to be, what will FDA do with its National Priority Voucher and what will the scientific community do with this and how it will play out in oncology. It’s definitely worth covering it, which is why I was delighted to see the story and we took it very, very seriously.
Sara Willa Ernst: Well, you were just mentioning this is something to kind of keep a pulse on and to see how the National Priority Vouchers are going to play out and how that’s going to affect cancer patients. I mean, the main question that I had throughout the entire reporting process is for all the clinical trials, it’s like, how do you think this is going to impact cancer patients? Do you think this might expand access for them at all if it’s legalized on the national level? Do you think this would potentially even draw in more money, whether that is from the federal government or that’s from philanthropy to specifically study this if there’s more recognition on the national level? The cancer researchers that I talked to said a combination of, I don’t know, I’m not sure, we’re going to have to see how this pans out and there’s a lot of question marks and in particular, it’s because the indications that these National Priority Vouchers are considering might not map on perfectly to what diagnoses or indications would be applicable for a cancer patient.
So there was specific mention of treatment-resistant depression and major depressive disorder. And from the cancer researchers that I spoke to, these are not necessarily extremely common amongst cancer patients. So what could be an alternative is actually off-label prescription. That is amongst the sources that I spoke to possibly a much more feasible option for cancer patients. And of course there are cost considerations in that. Will insurance companies actually cover something if it isn’t approved for a specific indication? There’s a lot of question marks there, but yeah, were you going to say something?
Paul Goldberg: Yeah, because you do run the risk of putting the cart before the horse, which is first show that it actually has a new impact, that it’s beneficial impact, get the thing approved and then talk about paying for it or expanding access or worse yet, prescribing it off label. So first get some data out there, then let’s talk about getting it out there. So data would be nice.
Sara Willa Ernst: Yeah. And my understanding is that there have been clinical trials, mostly phase I and phase II clinical trials for cancer patients as opposed to phase III trials and there’s a specific technical reason why. So I think data does exist to show that at least it’s safe for cancer patients, particularly psilocybin. But I think among the sources I talked to, they looked at these indications and they kind of were puzzled. They’re like, “Why these specific indications?” And so there might be some kind of scientific debate in the field around whether or not the specifics of the executive order is what should have happened.
Paul Goldberg: Yeah. We’ll cover it as it develops and you’re tracking it. So it will be a very interesting story about clinical trials and about pain control and other matters involving this. So it’d be a great story. Thank you for doing it. Thank you for focusing on it and we’ll see where it goes.
It’s also really interesting to see a story that is unlike anything else, which is a podcaster sends a text to the President of the United States and the other bit of it, which we probably should mention is the response that Joe Rogan got to the text. What was the response?
Sara Willa Ernst: This is a quote directly from the press conference. Joe Rogan said, “The text came back,” and this is from Donald Trump, “’Sounds great. Do you want FDA approval?’” And then Joe Rogan says, “It was literally that quick.”
Paul Goldberg: When the President of the United States can text you, saying, “Would you like an FDA approval?” I worry about prescribing, but especially off label. This thing is not approved, by the way, to give credit to FDA right now. That approval has not taken place. So we’ll see how it goes, and boy, will we be there on top of that one. It’s a very interesting story.
Sara Willa Ernst: Yeah. So people, keep an eye out for any kind of follow-up coverage, and… Yeah.
Paul Goldberg: Even in jest when you say, “Hey, would you like an FDA approval?” Well, it’s entirely possible that he’s being misquoted or quoted out of context that… Well, more likely misquoted. But again, it’s-
Sara Willa Ernst: It’s possible.
Paul Goldberg: Yeah. It’ll be very interesting to see what actually happens.
Sara Willa Ernst: Yeah. We’ll be keeping a pulse on this. Well, thank you so much, Paul, for being on the pod.
Paul Goldberg:Yeah. Thank you, Sara, and thanks for doing the wonderful story.
Sara Willa Ernst: All right. We’ll see you next week.
Paul Goldberg: See you next week.
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.
