Welcome to Entanglements. In this episode, hosts Brooke Borel and Anna Rothschild ask: Do we have enough scientific evidence to approve psychedelics as medicine? And if not, are the data pointing in that direction? Some experts say the drugs could treat a wide range of ailments, but there may be significant risks for certain patients.
As always, to dig in, our hosts invited two experts with differing opinions to share their points of view in an effort to find some common ground. The point isn’t to both-sides an issue or to try to force agreement. Instead, they aim to explore the nuance and subtleties that are often overlooked in heated online forums or in debate-style media.
Their guests this week are Albert Garcia-Romeu, an associate professor of psychiatry and behavioral sciences at Johns Hopkins School of Medicine, and Bertha Madras, a professor of psychobiology at Harvard Medical School.
Below is the full transcript of the podcast, lightly edited for clarity. New episodes drop on Wednesdays. You can also subscribe to Entanglements on Apple Podcasts and Spotify.
Brooke Borel: Anna?
Anna Rothschild: Yes.
Brooke Borel: What are your thoughts on mushrooms?
Anna Rothschild: Like as food?
Brooke Borel: No, I’m talking about psilocybin — the magic kind of mushrooms.
Anna Rothschild: Oh.
Brooke Borel: Psychedelic mushrooms.
Anna Rothschild: I don’t know if I’m allowed to answer this question on this podcast.
Brooke Borel: That’s fair. OK. So these drugs currently are illegal, at least in most places in the U.S. and definitely where we both live. So, maybe we plead the fifth on that question.
Anna Rothschild: Yes, I think that’s a good idea.
Brooke Borel: But today on the show, we are going to be digging into whether or not it should be OK to use these drugs and other psychedelics, at least in one specific case: For medical use.
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Brooke Borel: You’re listening to Entanglements, the show where we dig into controversies in science and try to find some common ground. I’m Brooke Borel, articles editor at Undark magazine.
Anna Rothschild: And I’m science journalist Anna Rothchild. So, Brooke. Psychedelics. Tell me more.
Brooke Borel: Today we’re going to be talking about psychedelics, particularly as a treatment for things like addiction and depression.
Anna Rothschild: This is super interesting to me. I know there are many societies throughout history that have used psychedelics as medicine, but I don’t know a ton about what clinical trials have been done.
Brooke Borel: Yeah. So psychedelics have been in clinical trials for years now. And for today’s show, we are mainly going to be talking about trials for psilocybin, which is mostly used for treating depression and addiction, and MDMA, which is mostly used for treating PTSD. But neither has been approved by the FDA yet.
Anna Rothschild: OK. How are the clinical trials looking?
Brooke Borel: Well, the quality of the data may be debatable, which is part of why I thought this would be a good episode. And today I have two guests, a neuroscientist and a psychologist, who have very different perspectives on whether it’s a good idea to get these drugs into the hands of doctors and patients more broadly. Specifically, I asked them: Do we have enough scientific evidence to get these drugs approved as medicine? And if not now, then is the evidence pointing in that direction?
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Al Garcia-Romeu: Not right at this moment, but we’re certainly approaching that threshold, I would say.
Brooke Borel: From your personal perspective on where the science is at this stage, do you feel comfortable knowing that that could happen within a year or two?
Al Garcia-Romeu: Yes.
Brooke Borel: This is Albert Garcia-Romeu. He goes by Al. He’s an associate professor of psychiatry and behavioral sciences at Johns Hopkins School of Medicine. He has been running trials on psychedelics for many years, and he’s been interested in altered states of consciousness, including with psychedelics, since long before he became a psychologist.
Al Garcia-Romeu: I studied Eastern religion and spirituality, meditation, philosophy of mind, and consciousness studies in undergraduate. I also had a lot of experiences in meditation, but also living in the wilderness. And I spent some time working for the U.S. Forest Service. Being outdoors for extended periods of time led to some really intense altered state experiences.
Brooke Borel: In grad school, Al got interested in mapping some of those Eastern spiritual traditions to Western practices. And now he’s actually running studies where they give people psilocybin. So far, most of that work has focused on treating tobacco addiction. More recently, though, Al and other scientists at Johns Hopkins have been looking at using the drug to treat a wide range of other disorders.
Al Garcia-Romeu: We’ve also branched out to start looking at other types of health conditions including Alzheimer’s disease, chronic Lyme disease, Amyotrophic lateral sclerosis, or ALS. That’s more in a palliative care type of model of treatment.
Brooke Borel: My understanding is a lot of this research relates to mental health. When you talk about palliative uses for this, is that trying to work with the mental health component of those serious ailments? Or is there some other thing that you’re looking at for therapies that are more physical?
Al Garcia-Romeu: Both. But often the symptoms that are being treated or targeted are more around things like depressive symptoms or anxiety: How do they feel in terms of their spiritual wellbeing and their sense of meaning and purpose in life. And so that’s really what we’re getting at.
Brooke Borel: What is it like to actually conduct a study on one of these psychedelics? Can you walk me through the process?
Al Garcia-Romeu: Yeah. The process is pretty straightforward. We have a screening process, which is: We make sure that the person is safe to receive a high dose of psilocybin.
Brooke Borel: What does that mean?
Al Garcia-Romeu: They don’t have any heart conditions. They don’t have a history of schizophrenia or bipolar disorder. They have good liver and kidney function.
Brooke Borel: Al said researchers typically screen out people with these conditions because they’re more likely to have a bad reaction to psilocybin. For people who make it into the trial, they meet with a facilitator or a therapist for several weeks. They go over things like their formative life experiences, their trauma history, and what kind of life improvements they’re seeking from the therapy. And the researchers also prepare the participants for what the trial will be like and how to navigate the experience with the drug.
Al Garcia-Romeu: Usually there will be at least one, sometimes as many as two or three administrations, usually using a high dose of a psychedelic like psilocybin, LSD, or MDMA. And then from there you would go into a sort of aftercare period, and that’s really geared towards both supporting therapeutic progress, unpacking and trying to make meaning of any experiences that came up during the dosing sessions, and generally just monitoring people’s progress. That is a process that can take several months and involve several administrations of the drug. But in some of these studies that have been published, we’ve seen that people will have benefits that’ll last months and sometimes years after going through a course like that.
Anna Rothschild: Wow. That is quite a process.
Brooke Borel: Yes. And particularly for these clinical trials, the researchers are typically aiming for a very structured, controlled setting. They are focused quite a bit on safety.
Anna Rothschild: I mean, I would hope they would be.
Brooke Borel Yeah. And Al thinks the results of trials like these are promising.
Al Garcia-Romeu: If we’re talking about people with existential distress, often their experiences can be really transformative in terms of their quality of life and how they approach their relationships after these experiences. For people with major depression, you can really lead to a change in their depressive symptom burden. For people with addictions — I primarily work with tobacco smokers in terms of people I’ve treated, and often the good outcome there is simply that they’ve just stopped smoking for years after going through something like this.
Brooke Borel: So Anna, in Al’s view, psychedelics in some cases could help solve problems that simply don’t have good solutions right now, at least for all patients.
Anna Rothschild: Right? Like if psilocybin could get someone to stop smoking who so far hasn’t been able to quit, that’s a pretty big deal.
Brooke Borel: Yes. And tobacco is the leading cause of preventable disease and death in the U.S. This statistic actually surprised me: More than 480,000 people are estimated to die every year in this country alone because of cigarette smoke.
Anna Rothschild: Whoa.
Brooke Borel: Yeah. And that doesn’t even include other tobacco, like chewing tobacco or whatever.
Anna Rothschild: That’s so many more people today than I was expecting.
Brooke Borel: Yes. And Al is thinking of other conditions, too, like depression. Some people do not respond to more standard drugs like SSRIs, right? And there’s some evidence that there can be relatively long lasting relief from a treatment of psilocybin compared to taking an SSRI every day, possibly indefinitely.
Anna Rothschild: Right. For the rest of your life. I know many people who would opt for a one and done, or yearly option or something like that, than having to take an SSRI every day.
Brooke Borel: Absolutely. And when you think of these possibilities, it’s no wonder that some people say that psychedelics could be revolutionary. However.
Anna Rothschild: Of course there’s a however.
Brooke Borel: Yes, of course there’s a however. There are also people who think that these drugs come with great risk. These drugs are powerful. There are lots of people who might not do very well with them.
Anna Rothschild: Right, like all of the people that researchers like Al screen out of their studies.
Brooke Borel: Yes, but also maybe some other people who we can’t easily screen out. Here’s what our next guest said about the risks and her biggest fears about medicalizing these drugs.
Bertha Madras: The most worrying to me is that it’s going to induce psychosis in people. Psychosis is probably one of the most fearsome conditions of the brain, and a psychosis can be a temporary one, or psychosis can persist.
Brooke Borel: This is Bertha Madras. She’s a professor of psychobiology at Harvard Medical School and her office is at McLean Hospital in Belmont, Massachusetts. She studies how psychoactive drugs affect the brain, and when she says psychosis, she’s referring to symptoms like paranoia, disordered thoughts, and hallucinations.
Bertha Madras: That fear is not just an emotional reaction to these drugs. That fear was realized in the 1950s and ’60s with people engaged in some of the most horrific behaviors because they were psychotic.
Brooke Borel: Bertha also had a more recent example of a case where psychedelic use went very badly.
Anna Rothschild: Oh no.
Brooke Borel: Anna, did you hear about what happened with the Alaska Airlines pilot in 2023?
Anna Rothschild: No, I missed this. What happened?
Brooke Borel: Yeah, so this pilot was riding as a deadheader on another pilot’s flight. So basically he’s hitching a ride from one city to another where he was scheduled for his next flight.
Anna Rothschild: OK.
Brooke Borel: So he is sitting up in the jump seat of the cockpit, not flying, but mid-flight, he starts messing with the plane and he actually tries to turn off the fuel switch for both engines.
Anna Rothschild: Oh my gosh.
Brooke Borel: Yeah. Pretty scary. He was ultimately restrained and no one was hurt. But it turned out that he thought he had to turn off those switches, according to reports.
Anna Rothschild: Oh gosh.
Brooke Borel: He had taken magic mushrooms 48 hours earlier, and even though they don’t typically last so long, somehow they were still affecting him. And he said later in an interview: “There was a feeling of being trapped. Like, am I trapped in this airplane? This is not real. I need to wake up.”
Anna Rothschild: Oh my gosh. That is so terrifying.
Brooke Borel: Really scary. I think scary for him, too, based on the interviews he gave later. No one was hurt, again, but he was charged with 83 counts of reckless endangerment.
Anna Rothschild: Wow. That could have been really bad.
Brooke Borel: Yeah. And this is just one example for Bertha. She isn’t new to the world of psychedelics. Today, most of her work may be on cannabis, but she’s been working with psychedelics since early in her career and still publishes about drugs and public policy.
Bertha Madras: When I was a graduate student, the first day I was there, my thesis advisor took me into his office and he said: “I have a collection of hallucinogens,” which is the term used at that time. And he said, “I would like you to investigate how they work.” And so I had access to every single hallucinogen known to human beings at the time.
Brooke Borel: According to Bertha, most of the drugs came in crystal form in little glass vials, but the LSD was injectable, which struck Bertha as odd. LSD is pretty potent and only takes a small amount to be effective. But there may have been a reason for it.
Bertha Madras: Years later, I found out that these were the LSD vials that had been used in CIA sponsored experiments at the Allen Memorial Institute where I was getting my Ph.D. They were injecting LSD into patients. Some of them with very mild depression, some of them with psychosis, some of them just unhappy and stressed and anxious. Many of them did not come out better than they came in. Many of them, in fact, got much worse.
Anna Rothschild: Was this like MKUltra or something, like the CIA experiments with drugs?
Brooke Borel: Maybe. Unclear. A quick fact check: We did follow up with Bertha, and while she suspects that these vials of LSD were from the CIA experiments, it was never officially confirmed for her.
Anna Rothschild: I mean that is understandable. The CIA is famously pretty tight-lipped.
Brooke Borel: Yes, definitely.
Anna Rothschild: It’s so interesting, though. Her introduction to psychedelics just couldn’t be more different from Al’s introduction, right?
Brooke Borel: Yeah, for sure. And I think it’s important to note that a lot of her research focuses on drug addiction, which also colors her perspective.
Anna Rothschild: I mean, surely research on psychedelics has come a long way since the 1950s, no? Like in terms of how well the studies are conducted, things like informed consent, stuff like that?
Brooke Borel: Yes, that is definitely true. So one thing to know about Bertha’s work is that although she isn’t directly studying these drugs any longer, she is regularly reviewing the literature on psilocybin and other psychedelics, writing and lecturing about that research, and so on. And her skepticism about the drugs isn’t just coming from her worries about these worst case outcomes like psychosis. She also doesn’t think that the clinical trials are strong enough to support approval or that we’re going to get there anytime soon.
Brooke Borel: Do we know enough to legalize psychedelics as medicine?
Bertha Madras: No. And the reason for this is very simple. The current clinical trials are not realistic in terms of bringing them to scale. What are the weaknesses of the current clinical trials? I can list three of them. Number one is the inclusion and exclusion criteria that are being used. A very high proportion of the clinical trials are done with people who have already tried hallucinogens. We do not know what will happen to people who have never been exposed.
Brooke Borel: Bertha says that in some trials she’s reviewed, the researchers have interviewed hundreds of people and then only selected like 50 to actually do the trial.
Bertha Madras: They’ve excluded so many people because of comorbid psychosis, because of suicidality, because of known risk factors, because of family history, because of preexisting psychiatric conditions. That limits the true risk of the drugs if brought to scale as a medicine. The other problem with recruitment is diversity. Most of the people who’ve been involved in these trials as subjects are Caucasian. They’re urban, they’re very well educated, high income people, and they’re aware of expected outcomes. We don’t know, if brought to scale, whether or not these exclusion criteria are going to reflect the general population. They certainly don’t at this point.
Anna Rothschild: OK. That’s a long list.
Brooke Borel: Yes. And to be clear, that’s just her first point, which boils down to: The studies conducted so far have only been done on a very narrow demographic slice. So it’s hard to extrapolate the results to a broader public, right? And her next point gets at something that is really considered key for a clinical trial, which is: Double blinding.
Anna Rothschild: As in, the people who are administering the studies and the participants in the studies are not supposed to know whether they’re actually getting a particular treatment or not.
Brooke Borel: Right. Usually you have a group getting an active drug and another getting a placebo, or a non-drug that looks like it could be the drug, as a control. And of course the studies track who gets what, but the people who actually hand out the drugs and the people who take the drugs, they don’t know. This helps ensure cleaner data, but with psychedelics…
Bertha Madras: Many of the studies don’t have placebo groups or active comparators.
Brooke Borel: Because if someone tried that, they would know immediately it’s a placebo.
Bertha Madras: They know what they’re getting and they have already been set up by therapists for expectations.
Anna Rothschild: This is a totally different thing from a clinical trial on an antibiotic or a blood pressure drug. Or even some of the drugs that these psychedelics are meant to replace, like SSRIs.
Brooke Borel: Right? If you take a drug like psilocybin, you’re going to have some really clear effects, right? You’re going to go on a little trip for maybe eight hours, and it’s really hard to find a good placebo for that.
Anna Rothschild: Of course, yeah.
Brooke Borel: And then Bertha’s next bullet point is: What happens next?
Bertha Madras: The third problem with the quality of the clinical trials is: What do you say to a person in an eight hour session if they get placebo? You know, the eight hour sessions with therapists are geared towards talking a person through a hallucinatory experience. What do you say? It must be a pretty awkward situation for both the subject and for the therapist.
Brooke Borel: And if those patients are unhappy because they’ve gone through this potentially awkward experience and haven’t gotten the real deal, that could skew the data.
Anna Rothschild: How so?
Brooke Borel: I mean, say you’re studying depression and comparing your psilocybin trial to an SSRI trial. So it might look like the patients given psilocybin are more responsive than the placebo group compared to the results in the SSRI trial.
Anna Rothschild: OK. Wait, just to make sure I understand: There’s that thing called the placebo effect, right? So people in a clinical trial, even if they’re getting the placebo, they won’t know they’re getting it. So they’ll sometimes report that they’re feeling better just because they’re given any pill, even if it’s not actually doing anything. But in a psilocybin trial, it’s obvious from moment one that you’re not getting the real deal, that you’re getting a placebo. So the difference between the people in the placebo group and the psilocybin group are just way more different.
Brooke Borel: Yeah, it could just be skewed in some way. And there could also be the opposite effect. It could be that there are people unhappy about getting the placebo, they know it’s a placebo, and that could also skew the results. I would probably be cranky if I had to spend eight hours alone with a therapist totally sober.
Anna Rothschild: Yeah. Holding your hand.
Brooke Borel: When I’m expecting this spiritual experience.
Anna Rothschild: Yeah. That makes a lot of sense to me. I mean, that does seem like a design problem here. Does Bertha think there’s any possibility at all for researchers to address these issues?
Brooke Borel: I asked about that.
Brooke Borel: If these drugs are studied more and if there are ways to get around some of these issues that you raised, do you think that there might still be a place for psychedelics in medicine at all? Or do you think that we’re never going to be able to find the evidence to approve these types of drugs for medicine?
Bertha Madras: I think to deny that some people feel it’s helped them would be to deny the data. So I certainly would not stand in the way of approving a drug if it proves to be safe and effective. But my fear is that once the FDA puts a stamp of approval on a drug, a physician can use it for anything on-label, off-label. Unless the FDA approves it with the most stringent of standards in terms of patient inclusion and exclusion, in terms of scrutinizing and screening and follow ups that could be almost prohibitive in terms of cost — I would not endorse it.
Anna Rothschild: Wow. These two have such different histories with this sort of research. Their perspectives are just so different.
Brooke Borel: Totally. They’ve really been looking at the evidence from completely different angles. Bertha is seeing all the fundamental flaws in how psychedelics research is conducted.
Anna Rothschild: Right. And Al probably doesn’t think these drugs are perfect, right? Like no drugs are perfect, but he’s just more focused on finding solutions to help people today.
Brooke Borel: Yeah. Who are suffering, right? Although he did agree with her on several of the limitations of the clinical trials as they are now. Still, I think the ways that they are coming at this really inform their risk tolerance when it comes to these drugs.
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Bertha Madras: My perspective comes not only from basic science and population studies, but also knowing the history and depth of what happened during the first phase of ecstatic affiliation with this class of drugs. And that has tainted my current view, and I think that the current studies are much more carefully constructed. The protocols are much more stringent. The guardrails are much better than they were. But the enthusiasm is still very reminiscent of those early days.
Brooke Borel: Al, I’m curious how you think about the cost benefit analysis in your head when you’re doing things like addiction studies, trying to get someone to quit smoking. How does that perhaps color your perspective on this?
Al Garcia-Romeu: Well, I mean, we’re looking at populations that have often not had success with available treatments, and so I really think of our work in terms of trying to develop novel avenues for people to get relief from some of the problems that they’re dealing with, whether that be something like anxiety, depression, or substance use related issues.
Brooke Borel: And I’m also curious, Al, so Bertha was just talking about the history of this kind of research and early studies on LSD that were perhaps conducted without some of the guardrails that occur these days. In our one-on-one interview, Bertha, I believe you called this generational forgetting. So I’m curious, Al, how do you respond to those concerns?
Al Garcia-Romeu: I was not around during the 1960s or ‘70s at all, but I’m certainly aware of some of the early wave of research that was done with these types of drugs, much of which was done in a fully unethical way, some of which included administering these drugs to people who were not providing any sort of informed consent. And so there were certainly many people harmed. But I mean, it’s for those reasons precisely that when we do our studies nowadays, that we were not bringing in people with a history of psychosis, that we’re not bringing in people with a history of recent suicidality, because we wanted to avoid harming anyone or even putting people at risk.
And we have a very good track record: Over 1,000 psilocybin dosing sessions here over the past 20 years, where we’re not having people go into the emergency room or going out and seeking psychiatric treatment urgently after the fact. But yeah, is that generalizable and can that kind of care be scaled? It’s still a difficult question I think that we need to answer.
Brooke Borel: Another difficult question is: If psychedelics do end up getting FDA approval, how do you keep the public from getting carried away?
Bertha Madras: When a drug is designated a medicine, it lowers the concern among the public with regard to their use. And with regard to the vast uptick in psilocybin use that we’re seeing now, emergency department mentions in several age groups. One of the reasons is that there has been so much hype about these compounds being medicines and therapeutic. And I think that the spillover into the general population cannot be ignored. If they become FDA approved, there will be a sense of security in using them.
Brooke Borel: Speaking of these drugs being used in the general population and the fact that they could perhaps expand or get more acceptance: Should these be approved by the FDA for therapies, there are some cases with pretty nightmare scenarios that have been tied to these drugs. What do you make of anecdotes like these? Are some of these incidents just inevitable but worth the risk when we’re also talking about being able to treat some of these populations for very serious ailments? Can better practices help prevent them? What do you think?
Al Garcia-Romeu: I mean, I definitely know that there are cases where people are harmed, and a lot of these are occurring outside of controlled clinical context. And when a drug is approved as a medicine, often the perceived risks of harm from that substance are kind of lowered. So people tend to think of them as safer because it is an approved medicine, in fact.
Brooke Borel: So in this conversation, there are a lot of ways in which it seems like you’ve agreed a lot actually.
Bertha Madras: Yes.
Brooke Borel: Which I’m not surprised about. But there still is this difference in your opinions that I’m seeing anyway. Do you think it’s a basic philosophical difference or a difference in how you’re reading the data, or a tolerance for risk? What do you think is going on here in how you are each seeing this world?
Bertha Madras: Al, would you like to begin?
Al Garcia-Romeu: Sure. I mean, I think there are risks, as we know, to a lot of approved medicines. Many approved antidepressants have black box warnings around suicidality, for instance. Seems to me like there may be some benefits here that are certainly worthwhile and there are some risks. And at least for me, the idea that we would completely forego the benefits, keep these drugs controlled because of the risks, seems overblown and unnecessary. And perhaps keeping some of those benefits in the box is going to end up causing more harm than good is sort of my standpoint.
Brooke Borel: And Bertha?
Bertha Madras: From my perspective, it’s the unintended consequences of unleashing another class of drugs on our society that worries me. So I think we are both doing a risk benefit equation. Al is viewing it from the perspective of a clinician who has seen benefit, and I respect that and I certainly acknowledge that people have benefited from these drugs.
I just wish I could trust the medical community. I wish I could trust professional organizations. But if I look at how many were given gifts by the industry with regard to opioids: We have no greater safeguards in place now than we did at that time with regard to pressures — financial, media pressures, and all sorts of pressures — to loosen the guardrails and make these into blockbuster drugs that are going to adversely affect the population.
So I wish that I could trust that Al could be cloned and have multiple people like him imposing the guardrails, imposing the scientific integrity that I believe he brings to this field. But I am very pessimistic that this actually can — I don’t think that Al is clonable and, and that’s the problem.
Brooke Borel: And as we’re wrapping up, I’m curious how each of you’re feeling about how this conversation went. Did you agree more than you expected? Did you disagree more than you expected? How are you feeling?
Al Garcia-Romeu: I mean, I felt like we agreed, and I think I had mentioned before we had the conversation that I suspect we may agree on a lot of these points. And you know, I think it really started with being very careful about talking about, well, the FDA criteria are X, Y, and Z. And are we there yet? No. And so if you have two people starting from that standpoint, then it seems like there’s a lot of common ground there, obviously.
Bertha Madras: I think there’s a lot of common ground and I think that my only concern is the public health policy implications of this class of drugs as well as others. And I think that, sometimes, is more difficult for people who are involved in seeing the benefits of a drug to extrapolate from that into what happens in the real world.
Brooke Borel: All right, Anna. Now what do you think of mushrooms?
Anna Rothschild: I will say, going into this I was probably pretty pro-mushrooms for medicinal use. I don’t want to speak for myself, but I know many people who have gotten lots of benefits from magic mushrooms. And while I didn’t know the specifics of the clinical trials, I think I have been hopeful that they could lead to some really positive treatment outcomes. So I was sort of open-minded to the idea, let’s say. I will say that Bertha’s point about recreating a scenario for therapists to work with patients, that seems like a really valid concern that I had not considered before. It does just seem like in our medical system, it will be pretty impossible to recreate what Al does with these patients, with the handholding for eight hours and that sort of thing.
Brooke Borel: Absolutely. And you think about the different ways in which these might be regulated on a state level, across all the different states, and how that might look different for different patients that might affect their outcomes. It’s going to be kind of wild to see how this could be released on the public and how it might actually play out.
Anna Rothschild: Yeah, and I think that even if you are a champion for this sort of stuff, like you want the rollout of these drugs to be good. You don’t want something really bad to happen because some doctor or therapist wasn’t caring for a patient adequately and then it just throws a wrench in legalizing this stuff more broadly for the people who it might actually help.
Brooke Borel: That is one reason why they are being so careful in doing these screenings for the clinical trials. I think part of it is just for the safety of the patients, but if they were including more people and there were bad outcomes, that’s also not great for the clinical trial, right? But you know, as Bertha mentioned, the downside of that is you don’t really know how this might be extrapolated to the broader population, and you don’t know how these potentially more ill-effects might actually play out and how often they do.
Anna Rothschild: Yeah.
Brooke Borel: And then another potential issue is off-label use, because once a drug is approved by the FDA, doctors can decide to prescribe it for different reasons than it was originally intended for.
Anna Rothschild: Totally. We saw that with Ozempic.
Brooke Borel: So many things. Have you been following the ketamine clinics that are popping up?
Anna Rothschild: I mean, I’ve heard about them, but I don’t really know much. So, what’s going on?
Brooke Borel: Right. So ketamine isn’t technically a psychedelic, but it is related to the drugs we’re talking about. And some people are using it to treat depression and stuff like that, but it’s not actually approved for that. It’s an anesthetic.
Anna Rothschild: Right. Interesting.
Brooke Borel: So it’s being used off-label. And it’s also being used differently, depending on what state you’re in and what clinic you go to — it’s just sort of a patchwork of what kind of care you’re going to get, what kind of support you’re going to get. It’s a little bit of a mess, right?
Anna Rothschild:I mean, that’s exactly what Bertha is worried about, basically.
Brooke Borel: Yes, exactly. I’m so curious if our listeners are willing to share their own experiences with psychedelics and other drugs, or just their opinion on this in general. What do you think?
Anna Rothschild: I absolutely want to read your emails about your experiences.
Brooke Borel: We’ll anonymize them.
Anna Rothschild: Please send them to us. Please, please, please. You can reach us [email protected]
Brooke Borel: And that’s it for this episode of Entanglements, brought to you by Undark magazine, which is published by the Knight Science Journalism Program at MIT. Our amazing producer and editor is Samia Bouzid. The show is fact-checked by Undark deputy editor Jane Reza. Our production editor is Amanda Grennell. And Adriana Lacy is our audience Engagement editor. Special thanks to our editor in chief, Tom Zeller, Jr. I’m Brooke Borel.
Anna Rothschild: And I’m Anna Rothchild. Thanks for listening. See you next time.