The Drug Report
The Drug Report
The Fallout of FDA's Decision on Lykos
This episode of the Drug Report podcast unpacks the FDA's recent decision to reject Lykos' psilocybin product intended for treating PTSD, a move that has sparked fierce debate. We also delve into the significant fallout for Lykos, from massive layoffs and leadership upheavals to the company's uncertain future. Plus, the tragic case of Matthew Perry is intertwined with broader concerns about the safety and efficacy of psychedelic treatments.
Follow the work of SAM and FDPS below:
https://learnaboutsam.org/
https://gooddrugpolicy.org/
https://thedrugreport.org/
On X:
https://twitter.com/learnaboutsam
https://twitter.com/GoodDrugPolicy
https://twitter.com/KevinSabet
https://twitter.com/LukeNiforatos
On Facebook: https://www.facebook.com/learnaboutsam
Yes or no? Do you believe nicotine is not addictive?
Speaker 2:I believe nicotine is not addictive. Yes, Congressman, cigarettes and nicotine clearly do not meet the classic definitions of addiction.
Speaker 1:I don't believe that nicotine for our products are addictive. I believe nicotine is not addictive. I believe that nicotine is not addictive. I believe that nicotine is not addictive.
Speaker 1:Hey everyone, this is Luke Nifiratis. I'm your host of the Drug Report podcast. Thank you so much for joining us today. I hope you had a wonderful weekend. Before I get started, I want to just thank our two co-sponsoring organizations, that's SAM, smart Approaches to Marijuana, as well as FDPS, the Foundation for Drug Policy Solutions, who make this possible. If you're not a subscriber to our Buy Twice Weekly newsletter, please become one. Go to thedrugreportorg. You can get our emails twice a week, and that's the content that really feeds what we do here on the podcast, and we give you a little analysis of that content here, as those of you who have subscribed and listened for a while know. So, without further ado, I have Jordan Davidson, our Head of Government Affairs at SAM and FDPS. He's joining me today. Thank you, jordan.
Speaker 2:Thanks, Luke, for having me on.
Speaker 1:Yes, and we are going to discuss the just giant news in drug policy that's really separate from marijuana, although a lot of overlap, separate from a number of the things we talked about, but we've had a few episodes on this, and that is the FDA's formal rejection of psilocybin the psilocybin product from Lycos, formerly known as MAPS, that was being had gone through clinical trials, you know, to be a recommended product, that would be FDA approved medicine, and the FDA rejected that after a advisory panel of the FDA had recommended rejection a few weeks ago, which we discussed on the podcast. So this is huge news and so I want to, jordan, I want to get your reaction, but before I do that, I just want to kind of summarize what has happened since that decision, because it started basically a domino effect. So the FDA announced on Friday that they were rejecting this psychedelic treatment for post-traumatic stress disorder which obviously, for all of us who've been following this in the popular media and culture, everyone thought that this was going to be approved. The news and the media and everyone was saying, oh, this know, this is just this miraculous treatment, there's no way it would get rejected. So this happened.
Speaker 1:Then you have reactions from people like RFK. He says you know this is his tweet scandalous decision by the FDA not to approve MDMA for treatment of PTSD. The pharma industry cannot abide by the precedent of a one-time treatment that can cure mental illness, reaching the root of trauma. So quite big words from RFK. Numerous studies show how it's the most efficacious treatment for PTSD ever studied. According to RFK, with minimal side effects. The second leading cause of death for young adults is suicide. The FDA's decision will have deadly consequences. That's RFK's take on this decision. And then you have you know, on the other side of things, slate ran a very, I thought, fair piece saying you know, the FDA didn't reject MDMA therapy because of big pharma, like RFK has alleged. It was because of shoddy science. And if you want to know how shoddy the science was and how bad their clinical trials data was, you can listen to one of our previous podcasts where we get into just how bad it was. Okay, so that's some of the reaction.
Speaker 1:Then what started happening was, you know, two days later, lycos lays off 75% of their staff. They bring in pharmaceutical company veterans Doblin, the psychedelics enthusiast who was running the company. He resigns the board. Now he says he's unleashed as an advocate. We'll see what that means, but my interpretation of that is that he is going to be advocating for legalization outside of the FDA process would be my guess, because I don't think this was ever about science for them to begin with. So Lycos is going to start to look like a legitimate medical company potentially. That seems to be what the board is leading them to do is look more like these pharmaceutical companies and try to get actual science and get their products approved with serious data. So Lycos, I'm basically just a complete catastrophe, any which way you look at it, totally shamed on the PR side. And the FDA rejects this based on the science, rejects these psychedelic drugs. Now, last thing I'm going to say.
Speaker 1:And then, jordan, I want to get your take on this, but you know, kind of tangentially to this, you have the situation where we had the news with Matthew Perry where he now the people who the doctors who were involved in providing him ketamine, the friends and assistants who were involved in providing him ketamine treatments those folks are now being charged with with criminal charges for their involvement in this matter.
Speaker 1:And again it comes to a situation where ketamine is just kind of lumped in with the psychedelics discussion. It was talked about what a miracle treatment this is, and Matthew Perry died as a result of hey, you know this is actually helping and it wasn't helping and he had become addicted to this. It's become evident in the discussion. So really, really heartbreaking story there, and now we're getting the latest update there. So there's what the media and the culture has said about these psychedelics, and then there's what the science showed, which led to the FDA rejection of MDMA as a medicine. So it's really interesting. We're at this place where the culture understands one thing and the science is in a completely different place. So, jordan, I'd love to hear your feedback on kind of where we're at here.
Speaker 2:Yeah, I agree with everything that you said, luke. Kind of, taking this from a federal affairs congressional standpoint, it's been interesting to see the reactions kind of both before, during and after this decision by the FDA. In Congress there are certain members who are vociferously pro-psychedelics and before the FDA made this decision they were passing legislation through congressional committees to kind of almost, in my view, prepare for this, thinking that this was a slam deal, just a slam dunk in the bag deal, that this would get approved and preempting that. And then, you know, science is kind of reviewed and FDA says nope, we're not going to do this, and the members of Congress, just like RFK, are outraged about it and they're saying how this was a disgrace and things like that and it's. It's just interesting to see our lawmakers react in such a way to a decision that is based on the science, that is based on the facts. You would think that folks you know I don't blame anyone for being open-minded wanting to explore something. The FDA explored this and they rejected it, right.
Speaker 2:I feel that members of Congress should be listening to what our experts are saying and listening to the scientists and instead they're really upset about this and I think this gets to a deeper kind of problem that we're seeing on Capitol Hill in regards to all drugs, but especially psychedelics, and we've seen it with marijuana. There's just this burgeoning industry and lobbying groups whether it is these kind of veterans groups that, quite frankly, is really hard for folks to kind of say no to, or these psychedelic legalization advocates that have really taken root in Congress, found their members who are going to support them and push, push, push, push, push until they get legislation across the finish line before any decisions are made, and so I think this is almost a. I guess, if you want to take a lesson from this, in policymaking, don't jump the gun right. These folks on Capitol Hill were jumping the gun, thinking that this was a done deal and it should be really government 101, that nothing is ever a done deal until it's finished, and so this was kind of the case of that, and you're just seeing how folks don't really listen to the science. One of our team members says this all the time During COVID, the mantra was follow the science, and now apparently some of the people who are even saying that during COVID have just tossed that by the wayside and are advocating for policies that aren't supported by the science.
Speaker 2:And you know I don't know, luke, if you've covered this in a past episode but just also to kind of go over Lycos or what used to be MAPS, you know, part of the reason that their research was rejected was not only just the scientific results but their methodology. I mean, it was stunning to me that the House Veteran Affairs Committee actually invited Lycos to testify when their company researchers working for their company engaged in sexual assault against a study participant who was under the influence of psychedelic drugs. Their board members have scammed senior citizens. They committed elder abuse against a Holocaust survivor. I mean really, really terrible things going on at this organization and this is who they're listening to. These are the experts, right? That should kind of tell you all that you need to know.
Speaker 1:Yeah, it's, you know, I think. And what's interesting too is in Congress. I mean, there was just recently, a week or two ago, a huge press conference on the steps of the Capitol with a whole bunch of members of Congress calling on the FDA to approve psychedelic medicines.
Speaker 2:Yep, yeah, it's, I don't. These agencies, right, are supposed to be able to independently analyze this for a reason and of course there's always congressional oversight and the checks and balances but there's a reason that the scientists aren't inviting members of Congress into the lab with them, right, to kind of analyze this data, because they're not the experts. Just like I don't want FDA researchers, you know, working on the House floor to pass a bill and voting on it. That's not what they're supposed to do. Members of Congress aren't supposed to like, like, weigh in in this kind of a way, um, to explicitly tell them this is what the science says.
Speaker 1:It's almost unprecedented, it's almost. I I couldn't think of another situation where you had members of congress dozens of them come together and do a press conference calling on our nation's body that is charged with approving medicines to approve a medicine. And also, as I said, you really don't see pharmaceutical companies not that they're the paragons of what's good in the world or perfect in any way, shape or sound. There's a lot of issues in that industry but you don't see pharmaceutical companies pre-promoting their products before they get approved, before they even get considered by the FDA, getting members of Congress to do a press conference in support of their upcoming medicine or product, whatever it is.
Speaker 1:It really seemed like with Lycos they had a whole social media, whole regular media campaign going on to subvert the neutral, science-based nature of the FDA's typical decision-making process. It seemed like they were trying to undermine it from the get-go. There was a whole operation to do that and basically it kind of feels like to me, almost like you know. You see press conferences like that. It's like advocates have a gun on the table. It's like we're either going to you know the gun is we're going to legalize these substances at the state level, everywhere and totally defy medicine again, like we did with medical marijuana, or you're going to approve our product through your FDA and screw the fact that we totally screwed up the entire clinical trial process.
Speaker 2:And this is just. I'd say, this is the. You know, I hate when those news anchors and pundits say I'm just asking questions, I'm just asking questions, but I'm going to pull one of those. I'm just asking a question here. Okay, folks, why why is it that you only see this type of stuff, press conferences and big statements when it comes to psychoactive substances? Why is it only for marijuana? Why is it only for MDMA? Why is it only for psilocybin? Like? Why didn't the members of Congress who did this press conference, why aren't they out on the steps, like, pushing for more widespread access to Ozempic? Like right, like great question. You know like what? Like right, like great question, you know like what? Like that, you don't see that. Or or like the alt, the new alzheimer's drug, right, like, like. Why don't you see?
Speaker 1:those you could argue not to get super legal here. But you could argue that the societal benefit of ozempic you know you think about that like obesity is one of the top factors for morbidities in this country. You could argue that the whole, like Congress, should take that up as a serious issue. I mean, I'm not an expert on Ozempic and I'm not certainly not an advocate for for taking any of these medicines for obesity. But, um, you know you could argue, based on the societal impact of of a substance like that, that that would potentially be worth time in Congress talking about.
Speaker 2:Well, the only person, the only person who talks about it is Bernie Sanders, who launches investigations into why it's so highly priced. That's the only.
Speaker 1:That's the only thing that right he doesn't have dozens of members of Congress.
Speaker 2:It's just interesting, right, like you, you see, you never see. You know why aren't they like you know, like drugs like, okay, drugs like Advil or some like. Why don't you see press conferences about substance? Obviously, that's been around for a long time. But like new drugs like that do, that are non-intoxicating, that do great things for people. Um, you don't see that and so I think it's. It's not my, my, my opinion is that this is not a coincidence.
Speaker 1:Yes, and it's not a coincidence, and it's not even just that's not even just a statement of opinion. I mean, you look at Lycos as a company. They changed their name from MAPS to kind of change the PR, but they were a bunch of psychedelics, users and activists I mean, doblin is a well-known psychedelics activist and they were pushing this. As you know. They were trying to get scientific validation for their wild claims they've made over decades, and it didn't work out because they tried to fudge the numbers. Now, all of this is not to say that some of these substances may not be approved by the FDA in the future. I think there's a strong chance the FDA very well might approve these substances for medicinal purposes in the future. They certainly have indicated that they likely will. The important piece of this, though, is to ensure the predictability of these drugs, that they will have a predictable effect on the patients that are taking them, and I think it's going to be very hard to get them ultimately approved.
Speaker 1:There's a lot of excitement around the potential, but you still have a situation where and there's a number of articles that have come out just in the last couple of days on you know, veterans who had very adverse reactions to some of these psychedelic drugs being taken for their PTSD. So there's still the situation where one person takes this and has, you know, a positive outcome, and another person takes the exact same dose and has an overwhelmingly negative outcome, and then another person has a violent outcome. And so I think, you know, with medicine they really tried, it's just an. There's a lot that goes into it, but predictability is a key piece of this, and so I think it's gonna be very difficult, but you know it may get approved at some point and if it follows through that process, great. But you can't do that where you're putting patients at risk, and that's what, unfortunately-.
Speaker 2:Also, I just like to say right, like when things get approved by the FDA, I think people think that that's a huge win and then everyone's just going to be able to do these drugs. Right Like there's a highly regulated process. It likely will only be able to go to a select group of people. Right Like there are certain, like we mentioned, ozempic. Right, they're kind of a loophole actually with Ozempic. But Ozempic is technically only supposed to be used for people with a certain type of diabetes. Now everyone says it's the weight loss drug. It's actually not supposed to be used for that and there's a loophole. But I think these psychoactive drugs will probably be even more tightly regulated. So it's not like just the next day anyone who's feeling a little off is all of a sudden going to just be able to pop ecstasy. You know, that's not how this is going to work either.
Speaker 1:Yeah, I have a sneaking suspicion we're going to hear that. Oh, it's still too hard for people to get access, like we haven't heard that before we have not Right.
Speaker 2:Oh yes, that's exactly right, it's all. It's all a slippery, slippery slope with this stuff.
Speaker 1:Correct, yeah, so I think it'll be important to. If it's going to be medicine, I think the FDA wants to make sure it's actually medicine and it's not something that's being used nefariously, and I think that's going to give companies like Lycos and Doblin advocates like Doblin a really hard time. So all right. Well, that concludes our discussion of the FDA's decision. It's a giant decision. It's one that we should take heat of, following the science when it comes to drug policy, not the hype. The hype is just so ridiculous and when you put it to the test so often, the hype is just. You know. When somebody tells you something is too good to be true, like this drug heals and changes everything, you know it's likely it is too good to be true. So I think that's an important thing. So, jordan, thank you for joining me. Um to all of you, our listeners, please rate us five stars, please leave us a nice review we always appreciate that and have a great rest of the week, thank you.