Ketamine is an anesthetic that has been growing in use as an off-label prescription to treat depression. Individuals can access the drug through telehealth appointments and clinics in person. But new reporting from Undark shows that many of these providers face few regulations, and much is still unknown about the drug. Dawn Fallik is an associate professor at the University of Delaware and a freelance medicine and science reporter. She covered this story through a grant from the Pulitzer Center and the University of Delaware and joins us to share more on what ketamine clinics look like in Oregon and around the U.S.
Note: The following transcript was transcribed digitally and validated for accuracy, readability and formatting by an OPB volunteer.
Jenn Chávez: This is Think Out Loud on OPB. I’m Jenn Chávez. Ketamine has been used as an anesthetic in operating rooms and emergency rooms for decades. More recently, it’s being used more and more as an off-label treatment for depression. It’s accessible through ketamine clinics or via telehealth, but its use as a mental health treatment is still largely unregulated.
To talk more about what this looks like for providers and patients in Oregon and across the country, I’m joined by Dawn Fallik. She’s an associate professor at the University of Delaware and a freelance medicine and science reporter, and she recently wrote about this for the publication Undark. Professor Fallik, welcome to the show.
Dawn Fallik: Oh, thank you so much. It’s fabulous to be here.
Chávez: Well, it is fabulous to have you. Thank you so much for your reporting. It was fascinating. So just to start out, for folks who may not have heard of it, can you describe what ketamine is?
Fallik: So, ketamine, if you’ve had your wisdom teeth out, you’ve probably had ketamine. It’s a very quick acting anesthetic that’s used in emergency rooms and operating rooms, and at the dentist’s office. It’s generally considered to be very safe. It’s been around for… Really it started being used in the Vietnam War, and so that’s mainly what it’s used for. It’s used as an anesthetic.
Chávez: And what type… I mean, obviously anesthetic is one effect, but what type of effects does ketamine have on the body?
Fallik: So the way it’s used for depression is that it kind of makes you disassociate, right? You separate sort of from your body, and it’s used specifically for treatment-resistant depression. So for example, about 30% of the people who have depression and take things like SSRIs like Prozac, Wellbutrin, it doesn’t work for them. And so they’ve tried other things, and ketamine is very often used as like a last-ditch effort to treat very severe depression. People who are suicidal, severely depressed in hopes that it can kind of separate them from their feelings and sort of lighten that load of depression.
Chávez: And I want to hear more about some of the experiences you heard from people who have used this treatment. But first, what kind of evidence or research is there around the benefits of ketamine therapy as a treatment for depression?
Fallik: So when this started being used, it was originally developed in the Vietnam War as a battlefield anesthetic. And then really in the late 1990s, researchers at Yale started looking at it for depression, and it kind of expanded from there. But there hasn’t been an enormous amount of research for off-label use of ketamine in the way that other drugs have been researched. And so, like the studies that have been done have shown that ketamine can make a very big difference.
So, for example, one recent study in April 2024, found that… They looked at people who were receiving intravenous ketamine, so through an IV, and they found that 71% of the participants reported feeling better. And so it’s sort of expanded from there, but there isn’t a lot of research about how it might conflict with other medications, what kind of patient might it be most helpful for, and we also don’t know a lot about the long-term impacts of ketamine, and that’s a big question that’s kind of hanging over a lot of these treatments right now.
Chávez: So as you mentioned, I mean, depression is a horrible illness. It can be deadly, of course, and I can totally see why this would appeal to folks who have tried other treatments without success, which must be so frustrating. What have you heard from people who’ve used ketamine in this way and what it did for them personally?
Fallik: So just to sort of explain, because a lot of people don’t know what off-label means…
Chávez: Mmm, yes please.
Fallik: So, it’s when you’re using ketamine ‒ and it has to be prescribed by a doctor or nurse practitioner or psychiatrist ‒ you go to a clinic. There are more than 1,500 clinics in the U.S. right now that are private clinics, and you can get an IV there. You can also get ketamine through something called a troche, which is a lozenge that you suck on ‒ you don’t swallow it ‒ that is a ketamine lozenge, and that’s very often used in telehealth groups or agencies.
You have to pay out of pocket for the most part for this off-label use for ketamine, because it’s being used in a manner that it’s not originally intended for. So was it originally intended for the ER or for getting your wisdom teeth out. And now it’s being used off-label for something else.
Chávez: So does that mean like the insurance, insurance is not covering it because it’s not being used for this previously approved use? Do I understand that right?
Fallik: Right, you’re exactly right. There is one form of ketamine called Spravato that was approved ‒ I think it was in 2019 ‒ and it’s a nasal spray. And that was the first time the FDA had approved a form of ketamine for treatment-resistant depression. And so that kind of created the explosion of the industry. So 10 years ago, there were 16 ‒ I think ‒ IV ketamine clinics, and now there are over 1,500 just 10 years later.
Chávez: Wow.
Fallik: So I just wanted to make clear like how it’s given and what it’s used for. You had asked about the people I talked to and what their experiences were with ketamine. Is that right?
Chávez: Yes, that’s right. I saw in your reporting that that you had spoken to different folks who used this for this purpose.
Fallik: Exactly. So we talked to a number of patients or clients, as the clinic sometimes calls them, and overwhelmingly it was just a very different experience from person to person. Very few people described the experience as a high, which I was surprised by. They described it as sort of a lightening, like a weight lifting, but it wasn’t really like a pleasant experience. There was one patient who described it as enjoyable, but some of them said that it didn’t work for them at all.
Some of them said that they found that things got better after about 10 sessions at a clinic, and some of them have been on ketamine ‒ they went on it daily ‒ and they found it to be very helpful and life changing. So, it’s really a wide range of experiences.
The problem is, with these clinics ‒ and clinic directors and researchers and government agencies all said the same thing ‒ is that there’s no regulation. So if you go to a clinic, like there’s several of them here in Philadelphia where I am, depending on the clinic you go to, you’re gonna receive a different dose, and a different number of sessions is going to be recommended.
And even aftercare is very different. So some of them don’t let you drive afterwards. Some of them say you can return to work. Some of them want you to have somebody to drive you home. Some of them have somebody sit there with you for a couple hours afterwards to make sure there’s no after effects. So it’s really varied from clinic to clinic, and that’s the big concern.
Chávez: Right. Yeah. And yeah, this is the big focus of your reporting, this kind of lack of consistent regulation and guidance. And like you spelled out for us the ways that ketamine is being prescribed permissibly, but off-label, as a mental health treatment. I mean, what does that mean in terms of the FDA specifically, because I know that they do have rule and regulatory structures for drugs that they’ve approved. What is their approach or view on this use of ketamine?
Fallik: So you’re right, if you go and you take Wellbutrin, they have what’s called a REMS, so a regulatory like outline of how the drug is supposed to be given. So you start at X dose and then you might titrate up to another dose, and these are the side effects to watch for. Like, it’s very outlined for the doctor and it might depend on your weight or past experience, but it’s very regulated.
And with Spravato, they do have ‒ which is the FDA approved form, that’s the nasal spray ‒ there are very strict regulations. If you have a history of manic symptoms, for example, you’re not supposed to take it. You have somebody, there’s like a two hour aftercare where somebody sits with you, and you’re supposed to get like a specific dose and the max supposed to be twice a week. But with off-label ketamine, like with the IV clinics or the troches ‒ the lozenges ‒ there’s no oversight from the FDA. It’s all down to the states now in very much the same way cannabis is. So I was trying to look at different states and see what the guidelines were, state by state. And very often there were no guidelines. Several clinic directors pointed out that you didn’t have to register with the state.
So for example, if you call Pennsylvania, the Department of Health, and you say, can I have a list of all of the private ketamine IV clinics, they don’t have it. You have to register as a business with the city that you’re in, but there’s no overarching guidelines. There’s nobody saying you should start with six sessions at this dose, with a maximum of XYZ sessions. And because you’re paying out of pocket, and it’s not cheap. $250 was, I think, the cheapest one we found, but most of them are about $600 to $1,000…
Chávez: Wow.
Fallik: …per session that you’re paying out of pocket. And a lot of the people that I talked to, I think the lowest number that was recommended was 10 sessions to start with. There was one clinic, I think that you could pay session by session, but most of them suggested six to 10 to start. So it’s not a small cost there. So it’s really up to the state. And like Oregon has very strict regulations for psilocybin, but very few for ketamine, and I was surprised to see that.
Chávez: Yeah, I wanted to ask you about that because that was something that I found really interesting in your story. You did speak with a ketamine provider in Oregon, a former ER doctor who now runs the clinic Cascade Psychedelic Medicine in Portland. And what really interested me about this is that he also provides psilocybin therapy there. So he’s doing both, and they’re differently regulated. What do you hear from him and the difference about the way the two treatments are regulated and how that comes into play at his clinic?
Fallik: Well, you know, I think both Dr. Meyer and the other clinic directors that I talked to were very frustrated by the lack of guidelines. Like, I think he called it a sea of confusion, or something like that. Where, with psilocybin, Oregon now requires providers to report something like an adverse event if it happens within 24 hours. So, let’s say you faint or you have a high heart rate or something that’s an extreme, an unexpected side effect, you have to report it to the state, and they’re also collecting data on the people who use it. So who is the population that is using psilocybin?
There’s none of that for ketamine. There’s no requirement to report adverse events, there’s, I think the only training that we could find specifically for ketamine was for naturopathic doctors. So it’s just, there was this frustration like, why does the state have strong regulations for one and not the other?
And the truth is, that’s true of many of the states that I looked at. Pennsylvania had guidelines which they put together voluntarily, that can’t be… They’re not regulated, they’re not enforceable. They’re suggestions. And that’s what we found over and over again was that, whether it was like an agency or an organization ‒ like there’s an organization of physicians and providers that use ketamine ‒ and they have a list of suggested guidelines for things like emergency equipment you should have at your clinic and the kind of training you should have. And questions that you should ask your patients or clients about their psychiatric history. But none of these are enforceable. And really, there were several people who said to me that they were just waiting for a malpractice lawsuit to happen…
Chávez: Wow.
Fallik: …because that was when, that’s when they can go in and say, okay, we need stronger enforcement.
Chávez: Oh, but waiting until there’s a malpractice lawsuit to make that enforcement. Yeah, I mean, what do you see as the potential risks here if the regulatory environment around ketamine as a depression treatment stays the same as it is now?
Fallik: Like I think there are two issues to look out for. One is that it’s very easy to abuse ketamine. It’s a very safe drug, but as we saw with Matthew Perry, there can be fatal consequences. The U.K. right now is having a lot of problems with ketamine as a party drug, and they’re starting to see people come in with long term use problems. It’s called ketamine bladder. So there’s that aspect here. Like if you’re a provider, it’s very hard to know if your patient is getting ketamine from other places. There’s some databases, but they don’t always include telehealth services. So if you’re getting ketamine from multiple providers, that’s hard for them to track.
And then the other thing is potential abuse on the provider side for overcharging patients, because it’s a pay for use service. It’s not covered by insurance, it’s all out of pocket, and nobody’s collecting this data. Nobody is saying, okay, this provider has charged this person for 20 visits. Then there can be abuse on that side. I know you have to have ‒ if you’re prescribing ketamine ‒ you have to have a DEA license, but that’s really the only thing.
Chávez: Well, thank you so much for joining us and talking us through your fascinating reporting.
Fallik: I know, I’ve been wanting to talk about this forever.
Chávez: Me too. Well, thank you.
Fallik: It’s really an interesting topic. Thank you so much for the interview.
Chávez: Absolutely. I’ve been speaking with Dawn Fallik, an associate professor at the University of Delaware and a freelance medicine and science reporter.
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