August 19, 2024 • 17 mins
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.
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Episode Transcript
Available transcripts are automatically generated. Complete accuracy is not guaranteed.
Speaker 1 (00:00):
Yes or no?
Do you believe nicotine is notaddictive?
Speaker 2 (00:02):
I believe nicotine is not addictive.
Yes, Congressman, cigarettesand nicotine clearly do not meet
the classic definitions ofaddiction.
Speaker 1 (00:11):
I don't believe that nicotine for our products are
addictive.
I believe nicotine is notaddictive.
I believe that nicotine is notaddictive.
I believe that nicotine is notaddictive.
Hey everyone, this is LukeNifiratis.
I'm your host of the DrugReport podcast.
Thank you so much for joiningus today.
I hope you had a wonderfulweekend.
Before I get started, I want tojust thank our two
(00:33):
co-sponsoring organizations,that's SAM, smart Approaches to
Marijuana, as well as FDPS, theFoundation for Drug Policy
Solutions, who make thispossible.
If you're not a subscriber toour Buy Twice Weekly newsletter,
please become one.
Go to thedrugreportorg.
You can get our emails twice aweek, and that's the content
that really feeds what we dohere on the podcast, and we give
(00:54):
you a little analysis of thatcontent here, as those of you
who have subscribed and listenedfor a while know.
So, without further ado, I haveJordan Davidson, our Head of
Government Affairs at SAM andFDPS.
He's joining me today.
Thank you, jordan.
Speaker 2 (01:07):
Thanks, Luke, for having me on.
Speaker 1 (01:09):
Yes, and we are going to discuss the just giant news
in drug policy that's reallyseparate from marijuana,
although a lot of overlap,separate from a number of the
things we talked about, butwe've had a few episodes on this
, and that is the FDA's formalrejection of psilocybin the
psilocybin product from Lycos,formerly known as MAPS, that was
(01:33):
being had gone through clinicaltrials, you know, to be a
recommended product, that wouldbe FDA approved medicine, and
the FDA rejected that after aadvisory panel of the FDA had
recommended rejection a fewweeks ago, which we discussed on
the podcast.
So this is huge news and so Iwant to, jordan, I want to get
(01:55):
your reaction, but before I dothat, I just want to kind of
summarize what has happenedsince that decision, because it
started basically a dominoeffect.
So the FDA announced on Fridaythat they were rejecting this
psychedelic treatment forpost-traumatic stress disorder
which obviously, for all of uswho've been following this in
(02:16):
the popular media and culture,everyone thought that this was
going to be approved.
The news and the media andeveryone was saying, oh, this
know, this is just thismiraculous treatment, there's no
way it would get rejected.
So this happened.
Then you have reactions frompeople like RFK.
He says you know this is histweet scandalous decision by the
(02:38):
FDA not to approve MDMA fortreatment of PTSD.
The pharma industry cannotabide by the precedent of a
one-time treatment that can curemental illness, reaching the
root of trauma.
So quite big words from RFK.
Numerous studies show how it'sthe most efficacious treatment
for PTSD ever studied.
According to RFK, with minimalside effects.
(03:00):
The second leading cause ofdeath for young adults is
suicide.
The FDA's decision will havedeadly consequences.
That's RFK's take on thisdecision.
And then you have you know, onthe other side of things, slate
ran a very, I thought, fairpiece saying you know, the FDA
didn't reject MDMA therapybecause of big pharma, like RFK
(03:21):
has alleged.
It was because of shoddyscience.
And if you want to know howshoddy the science was and how
bad their clinical trials datawas, you can listen to one of
our previous podcasts where weget into just how bad it was.
Okay, so that's some of thereaction.
Then what started happening was,you know, two days later, lycos
lays off 75% of their staff.
(03:42):
They bring in pharmaceuticalcompany veterans Doblin, the
psychedelics enthusiast who wasrunning the company.
He resigns the board.
Now he says he's unleashed asan advocate.
We'll see what that means, butmy interpretation of that is
that he is going to beadvocating for legalization
outside of the FDA process wouldbe my guess, because I don't
(04:03):
think this was ever aboutscience for them to begin with.
So Lycos is going to start tolook like a legitimate medical
company potentially.
That seems to be what the boardis leading them to do is look
more like these pharmaceuticalcompanies and try to get actual
science and get their productsapproved with serious data.
So Lycos, I'm basically just acomplete catastrophe, any which
(04:25):
way you look at it, totallyshamed on the PR side.
And the FDA rejects this basedon the science, rejects these
psychedelic drugs.
Now, last thing I'm going tosay.
And then, jordan, I want to getyour take on this, but you know,
kind of tangentially to this,you have the situation where we
had the news with Matthew Perrywhere he now the people who the
doctors who were involved inproviding him ketamine, the
(04:47):
friends and assistants who wereinvolved in providing him
ketamine treatments those folksare now being charged with with
criminal charges for theirinvolvement in this matter.
And again it comes to asituation where ketamine is just
kind of lumped in with thepsychedelics discussion.
It was talked about what amiracle treatment this is, and
Matthew Perry died as a resultof hey, you know this is
(05:08):
actually helping and it wasn'thelping and he had become
addicted to this.
It's become evident in thediscussion.
So really, really heartbreakingstory there, and now we're
getting the latest update there.
So there's what the media andthe culture has said about these
psychedelics, and then there'swhat the science showed, which
led to the FDA rejection of MDMAas a medicine.
(05:29):
So it's really interesting.
We're at this place where theculture understands one thing
and the science is in acompletely different place.
So, jordan, I'd love to hearyour feedback on kind of where
we're at here.
Speaker 2 (05:39):
Yeah, I agree with everything that you said, luke.
Kind of, taking this from afederal affairs congressional
standpoint, it's beeninteresting to see the reactions
kind of both before, during andafter this decision by the FDA.
In Congress there are certainmembers who are vociferously
(05:59):
pro-psychedelics and before theFDA made this decision they were
passing legislation throughcongressional committees to kind
of almost, in my view, preparefor this, thinking that this was
a slam deal, just a slam dunkin the bag deal, that this would
get approved and preemptingthat.
(06:20):
And then, you know, science iskind of reviewed and FDA says
nope, we're not going to do this, and the members of Congress,
just like RFK, are outragedabout it and they're saying how
this was a disgrace and thingslike that and it's.
It's just interesting to seeour lawmakers react in such a
(06:42):
way to a decision that is basedon the science, that is based on
the facts.
You would think that folks youknow I don't blame anyone for
being open-minded wanting toexplore something.
The FDA explored this and theyrejected it, right.
I feel that members of Congressshould be listening to what our
experts are saying and listeningto the scientists and instead
they're really upset about thisand I think this gets to a
(07:05):
deeper kind of problem thatwe're seeing on Capitol Hill in
regards to all drugs, butespecially psychedelics, and
we've seen it with marijuana.
There's just this burgeoningindustry and lobbying groups
whether it is these kind ofveterans groups that, quite
frankly, is really hard forfolks to kind of say no to, or
these psychedelic legalizationadvocates that have really taken
(07:28):
root in Congress, found theirmembers who are going to support
them and push, push, push, push, push until they get
legislation across the finishline before any decisions are
made, and so I think this isalmost a.
I guess, if you want to take alesson from this, in
policymaking, don't jump the gunright.
These folks on Capitol Hillwere jumping the gun, thinking
(07:50):
that this was a done deal and itshould be really government 101
, that nothing is ever a donedeal until it's finished, and so
this was kind of the case ofthat, and you're just seeing how
folks don't really listen tothe science.
One of our team members saysthis all the time During COVID,
(08:10):
the mantra was follow thescience, and now apparently some
of the people who are evensaying that during COVID have
just tossed that by the waysideand are advocating for policies
that aren't supported by thescience.
And you know I don't know, luke,if you've covered this in a
past episode but just also tokind of go over Lycos or what
used to be MAPS, you know, partof the reason that their
(08:32):
research was rejected was notonly just the scientific results
but their methodology.
I mean, it was stunning to methat the House Veteran Affairs
Committee actually invited Lycosto testify when their company
researchers working for theircompany engaged in sexual
assault against a studyparticipant who was under the
influence of psychedelic drugs.
(08:53):
Their board members havescammed senior citizens.
They committed elder abuseagainst a Holocaust survivor.
I mean really, really terriblethings going on at this
organization and this is whothey're listening to.
These are the experts, right?
That should kind of tell youall that you need to know.
Speaker 1 (09:10):
Yeah, it's, you know, I think.
And what's interesting too isin Congress.
I mean, there was just recently, a week or two ago, a huge
press conference on the steps ofthe Capitol with a whole bunch
of members of Congress callingon the FDA to approve
psychedelic medicines.
Speaker 2 (09:26):
Yep, yeah, it's, I don't.
These agencies, right, aresupposed to be able to
independently analyze this for areason and of course there's
always congressional oversightand the checks and balances but
there's a reason that thescientists aren't inviting
members of Congress into the labwith them, right, to kind of
(09:49):
analyze this data, becausethey're not the experts.
Just like I don't want FDAresearchers, you know, working
on the House floor to pass abill and voting on it.
That's not what they'resupposed to do.
Members of Congress aren'tsupposed to like, like, weigh in
in this kind of a way, um, toexplicitly tell them this is
what the science says.
Speaker 1 (10:09):
It's almost unprecedented, it's almost.
I I couldn't think of anothersituation where you had members
of congress dozens of them cometogether and do a press
conference calling on ournation's body that is charged
with approving medicines toapprove a medicine.
And also, as I said, you reallydon't see pharmaceutical
(10:30):
companies not that they're theparagons of what's good in the
world or perfect in any way,shape or sound.
There's a lot of issues in thatindustry but you don't see
pharmaceutical companiespre-promoting their products
before they get approved, beforethey even get considered by the
FDA, getting members ofCongress to do a press
conference in support of theirupcoming medicine or product,
(10:52):
whatever it is.
It really seemed like with Lycosthey had a whole social media,
whole regular media campaigngoing on to subvert the neutral,
science-based nature of theFDA's typical decision-making
(11:14):
process.
It seemed like they were tryingto undermine it from the get-go
.
There was a whole operation todo that and basically it kind of
feels like to me, almost likeyou know.
You see press conferences likethat.
It's like advocates have a gunon the table.
It's like we're either going toyou know the gun is we're going
to legalize these substances atthe state level, everywhere and
totally defy medicine again,like we did with medical
(11:36):
marijuana, or you're going toapprove our product through your
FDA and screw the fact that wetotally screwed up the entire
clinical trial process.
Speaker 2 (11:44):
And this is just.
I'd say, this is the.
You know, I hate when thosenews anchors and pundits say I'm
just asking questions, I'm justasking questions, but I'm going
to pull one of those.
I'm just asking a question here.
Okay, folks, why why is it thatyou only see this type of stuff
, press conferences and bigstatements when it comes to
(12:06):
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 ofCongress who did this press
conference, why aren't they outon the steps, like, pushing for
more widespread access toOzempic?
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.
(12:26):
Or or like the alt, the newalzheimer's drug, right, like,
like.
Why don't you see?
Speaker 1 (12:31):
those you could argue not to get super legal here.
But you could argue that thesocietal benefit of ozempic you
know you think about that likeobesity is one of the top
factors for morbidities in thiscountry.
You could argue that the whole,like Congress, should take that
up as a serious issue.
I mean, I'm not an expert onOzempic and I'm not certainly
not an advocate for for takingany of these medicines for
(12:52):
obesity.
But, um, you know you couldargue, based on the societal
impact of of a substance likethat, that that would
potentially be worth time inCongress talking about.
Speaker 2 (13:02):
Well, the only person , the only person who talks
about it is Bernie Sanders, wholaunches investigations into why
it's so highly priced.
That's the only.
Speaker 1 (13:09):
That's the only thing that right he doesn't have
dozens of members of Congress.
Speaker 2 (13:15):
It's just interesting , right, like you, you see, you
never see.
You know why aren't they likeyou know, like drugs like, okay,
drugs like Advil or some like.
Why don't you see pressconferences about substance?
Obviously, that's been aroundfor 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 Ithink it's.
(13:35):
It's not my, my, my opinion isthat this is not a coincidence.
Speaker 1 (13:40):
Yes, and it's not a coincidence, and it's not even
just that's not even just astatement of opinion.
I mean, you look at Lycos as acompany.
They changed their name fromMAPS to kind of change the PR,
but they were a bunch ofpsychedelics, users and
activists I mean, doblin is awell-known psychedelics activist
and they were pushing this.
As you know.
They were trying to getscientific validation for their
(14:01):
wild claims they've made overdecades, and it didn't work out
because they tried to fudge thenumbers.
Now, all of this is not to saythat some of these substances
may not be approved by the FDAin the future.
I think there's a strong chancethe FDA very well might approve
these substances for medicinalpurposes in the future.
They certainly have indicatedthat they likely will.
(14:23):
The important piece of this,though, is to ensure the
predictability of these drugs,that they will have a
predictable effect on thepatients that are taking them,
and I think it's going to bevery hard to get them ultimately
approved.
There's a lot of excitementaround the potential, but you
still have a situation where andthere's a number of articles
that have come out just in thelast couple of days on you know,
(14:44):
veterans who had very adversereactions to some of these
psychedelic drugs being takenfor their PTSD.
So there's still the situationwhere one person takes this and
has, you know, a positiveoutcome, and another person
takes the exact same dose andhas an overwhelmingly negative
outcome, and then another personhas a violent outcome.
And so I think, you know, withmedicine they really tried, it's
(15:07):
just an.
There's a lot that goes into it, but predictability is a key
piece of this, and so I thinkit's gonna be very difficult,
but you know it may get approvedat some point and if it follows
through that process, great.
But you can't do that whereyou're putting patients at risk,
and that's what, unfortunately-.
Speaker 2 (15:21):
Also, I just like to say right, like when things get
approved by the FDA, I thinkpeople think that that's a huge
win and then everyone's justgoing to be able to do these
drugs.
Right Like there's a highlyregulated process.
It likely will only be able togo to a select group of people.
Right Like there are certain,like we mentioned, ozempic.
(15:41):
Right, they're kind of aloophole actually with Ozempic.
But Ozempic is technically onlysupposed to be used for people
with a certain type of diabetes.
Now everyone says it's theweight loss drug.
It's actually not supposed tobe used for that and there's a
loophole.
But I think these psychoactivedrugs will probably be even more
tightly regulated.
So it's not like just the nextday anyone who's feeling a
(16:03):
little off is all of a suddengoing to just be able to pop
ecstasy.
You know, that's not how thisis going to work either.
Speaker 1 (16:09):
Yeah, I have a sneaking suspicion we're going
to hear that.
Oh, it's still too hard forpeople to get access, like we
haven't heard that before wehave not Right.
Speaker 2 (16:19):
Oh yes, that's exactly right, it's all.
It's all a slippery, slipperyslope with this stuff.
Speaker 1 (16:24):
Correct, yeah, so I think it'll be important to.
If it's going to be medicine, Ithink the FDA wants to make
sure it's actually medicine andit's not something that's being
used nefariously, and I thinkthat's going to give companies
like Lycos and Doblin advocateslike Doblin a really hard time.
So all right.
Well, that concludes ourdiscussion of the FDA's decision
.
It's a giant decision.
It's one that we should takeheat of, following the science
(16:47):
when it comes to drug policy,not the hype.
The hype is just so ridiculousand when you put it to the test
so often, the hype is just.
You know.
When somebody tells yousomething is too good to be true
, like this drug heals andchanges everything, you know
it's likely it is too good to betrue.
So I think that's an importantthing.
So, jordan, thank you forjoining me.
Um to all of you, our listeners, please rate us five stars,
(17:08):
please leave us a nice review wealways appreciate that and have
a great rest of the week, thankyou.
Yes or no?
Do you believe nicotine is notaddictive?
Speaker 2 (00:02):
I believe nicotine is not addictive.
Yes, Congressman, cigarettesand nicotine clearly do not meet
the classic definitions ofaddiction.
Speaker 1 (00:11):
I don't believe that nicotine for our products are
addictive.
I believe nicotine is notaddictive.
I believe that nicotine is notaddictive.
I believe that nicotine is notaddictive.
Hey everyone, this is LukeNifiratis.
I'm your host of the DrugReport podcast.
Thank you so much for joiningus today.
I hope you had a wonderfulweekend.
Before I get started, I want tojust thank our two
(00:33):
co-sponsoring organizations,that's SAM, smart Approaches to
Marijuana, as well as FDPS, theFoundation for Drug Policy
Solutions, who make thispossible.
If you're not a subscriber toour Buy Twice Weekly newsletter,
please become one.
Go to thedrugreportorg.
You can get our emails twice aweek, and that's the content
that really feeds what we dohere on the podcast, and we give
(00:54):
you a little analysis of thatcontent here, as those of you
who have subscribed and listenedfor a while know.
So, without further ado, I haveJordan Davidson, our Head of
Government Affairs at SAM andFDPS.
He's joining me today.
Thank you, jordan.
Speaker 2 (01:07):
Thanks, Luke, for having me on.
Speaker 1 (01:09):
Yes, and we are going to discuss the just giant news
in drug policy that's reallyseparate from marijuana,
although a lot of overlap,separate from a number of the
things we talked about, butwe've had a few episodes on this
, and that is the FDA's formalrejection of psilocybin the
psilocybin product from Lycos,formerly known as MAPS, that was
(01:33):
being had gone through clinicaltrials, you know, to be a
recommended product, that wouldbe FDA approved medicine, and
the FDA rejected that after aadvisory panel of the FDA had
recommended rejection a fewweeks ago, which we discussed on
the podcast.
So this is huge news and so Iwant to, jordan, I want to get
(01:55):
your reaction, but before I dothat, I just want to kind of
summarize what has happenedsince that decision, because it
started basically a dominoeffect.
So the FDA announced on Fridaythat they were rejecting this
psychedelic treatment forpost-traumatic stress disorder
which obviously, for all of uswho've been following this in
(02:16):
the popular media and culture,everyone thought that this was
going to be approved.
The news and the media andeveryone was saying, oh, this
know, this is just thismiraculous treatment, there's no
way it would get rejected.
So this happened.
Then you have reactions frompeople like RFK.
He says you know this is histweet scandalous decision by the
(02:38):
FDA not to approve MDMA fortreatment of PTSD.
The pharma industry cannotabide by the precedent of a
one-time treatment that can curemental illness, reaching the
root of trauma.
So quite big words from RFK.
Numerous studies show how it'sthe most efficacious treatment
for PTSD ever studied.
According to RFK, with minimalside effects.
(03:00):
The second leading cause ofdeath for young adults is
suicide.
The FDA's decision will havedeadly consequences.
That's RFK's take on thisdecision.
And then you have you know, onthe other side of things, slate
ran a very, I thought, fairpiece saying you know, the FDA
didn't reject MDMA therapybecause of big pharma, like RFK
(03:21):
has alleged.
It was because of shoddyscience.
And if you want to know howshoddy the science was and how
bad their clinical trials datawas, you can listen to one of
our previous podcasts where weget into just how bad it was.
Okay, so that's some of thereaction.
Then what started happening was,you know, two days later, lycos
lays off 75% of their staff.
(03:42):
They bring in pharmaceuticalcompany veterans Doblin, the
psychedelics enthusiast who wasrunning the company.
He resigns the board.
Now he says he's unleashed asan advocate.
We'll see what that means, butmy interpretation of that is
that he is going to beadvocating for legalization
outside of the FDA process wouldbe my guess, because I don't
(04:03):
think this was ever aboutscience for them to begin with.
So Lycos is going to start tolook like a legitimate medical
company potentially.
That seems to be what the boardis leading them to do is look
more like these pharmaceuticalcompanies and try to get actual
science and get their productsapproved with serious data.
So Lycos, I'm basically just acomplete catastrophe, any which
(04:25):
way you look at it, totallyshamed on the PR side.
And the FDA rejects this basedon the science, rejects these
psychedelic drugs.
Now, last thing I'm going tosay.
And then, jordan, I want to getyour take on this, but you know,
kind of tangentially to this,you have the situation where we
had the news with Matthew Perrywhere he now the people who the
doctors who were involved inproviding him ketamine, the
(04:47):
friends and assistants who wereinvolved in providing him
ketamine treatments those folksare now being charged with with
criminal charges for theirinvolvement in this matter.
And again it comes to asituation where ketamine is just
kind of lumped in with thepsychedelics discussion.
It was talked about what amiracle treatment this is, and
Matthew Perry died as a resultof hey, you know this is
(05:08):
actually helping and it wasn'thelping and he had become
addicted to this.
It's become evident in thediscussion.
So really, really heartbreakingstory there, and now we're
getting the latest update there.
So there's what the media andthe culture has said about these
psychedelics, and then there'swhat the science showed, which
led to the FDA rejection of MDMAas a medicine.
(05:29):
So it's really interesting.
We're at this place where theculture understands one thing
and the science is in acompletely different place.
So, jordan, I'd love to hearyour feedback on kind of where
we're at here.
Speaker 2 (05:39):
Yeah, I agree with everything that you said, luke.
Kind of, taking this from afederal affairs congressional
standpoint, it's beeninteresting to see the reactions
kind of both before, during andafter this decision by the FDA.
In Congress there are certainmembers who are vociferously
(05:59):
pro-psychedelics and before theFDA made this decision they were
passing legislation throughcongressional committees to kind
of almost, in my view, preparefor this, thinking that this was
a slam deal, just a slam dunkin the bag deal, that this would
get approved and preemptingthat.
(06:20):
And then, you know, science iskind of reviewed and FDA says
nope, we're not going to do this, and the members of Congress,
just like RFK, are outragedabout it and they're saying how
this was a disgrace and thingslike that and it's.
It's just interesting to seeour lawmakers react in such a
(06:42):
way to a decision that is basedon the science, that is based on
the facts.
You would think that folks youknow I don't blame anyone for
being open-minded wanting toexplore something.
The FDA explored this and theyrejected it, right.
I feel that members of Congressshould be listening to what our
experts are saying and listeningto the scientists and instead
they're really upset about thisand I think this gets to a
(07:05):
deeper kind of problem thatwe're seeing on Capitol Hill in
regards to all drugs, butespecially psychedelics, and
we've seen it with marijuana.
There's just this burgeoningindustry and lobbying groups
whether it is these kind ofveterans groups that, quite
frankly, is really hard forfolks to kind of say no to, or
these psychedelic legalizationadvocates that have really taken
(07:28):
root in Congress, found theirmembers who are going to support
them and push, push, push, push, push until they get
legislation across the finishline before any decisions are
made, and so I think this isalmost a.
I guess, if you want to take alesson from this, in
policymaking, don't jump the gunright.
These folks on Capitol Hillwere jumping the gun, thinking
(07:50):
that this was a done deal and itshould be really government 101
, that nothing is ever a donedeal until it's finished, and so
this was kind of the case ofthat, and you're just seeing how
folks don't really listen tothe science.
One of our team members saysthis all the time During COVID,
(08:10):
the mantra was follow thescience, and now apparently some
of the people who are evensaying that during COVID have
just tossed that by the waysideand are advocating for policies
that aren't supported by thescience.
And you know I don't know, luke,if you've covered this in a
past episode but just also tokind of go over Lycos or what
used to be MAPS, you know, partof the reason that their
(08:32):
research was rejected was notonly just the scientific results
but their methodology.
I mean, it was stunning to methat the House Veteran Affairs
Committee actually invited Lycosto testify when their company
researchers working for theircompany engaged in sexual
assault against a studyparticipant who was under the
influence of psychedelic drugs.
(08:53):
Their board members havescammed senior citizens.
They committed elder abuseagainst a Holocaust survivor.
I mean really, really terriblethings going on at this
organization and this is whothey're listening to.
These are the experts, right?
That should kind of tell youall that you need to know.
Speaker 1 (09:10):
Yeah, it's, you know, I think.
And what's interesting too isin Congress.
I mean, there was just recently, a week or two ago, a huge
press conference on the steps ofthe Capitol with a whole bunch
of members of Congress callingon the FDA to approve
psychedelic medicines.
Speaker 2 (09:26):
Yep, yeah, it's, I don't.
These agencies, right, aresupposed to be able to
independently analyze this for areason and of course there's
always congressional oversightand the checks and balances but
there's a reason that thescientists aren't inviting
members of Congress into the labwith them, right, to kind of
(09:49):
analyze this data, becausethey're not the experts.
Just like I don't want FDAresearchers, you know, working
on the House floor to pass abill and voting on it.
That's not what they'resupposed to do.
Members of Congress aren'tsupposed to like, like, weigh in
in this kind of a way, um, toexplicitly tell them this is
what the science says.
Speaker 1 (10:09):
It's almost unprecedented, it's almost.
I I couldn't think of anothersituation where you had members
of congress dozens of them cometogether and do a press
conference calling on ournation's body that is charged
with approving medicines toapprove a medicine.
And also, as I said, you reallydon't see pharmaceutical
(10:30):
companies not that they're theparagons of what's good in the
world or perfect in any way,shape or sound.
There's a lot of issues in thatindustry but you don't see
pharmaceutical companiespre-promoting their products
before they get approved, beforethey even get considered by the
FDA, getting members ofCongress to do a press
conference in support of theirupcoming medicine or product,
(10:52):
whatever it is.
It really seemed like with Lycosthey had a whole social media,
whole regular media campaigngoing on to subvert the neutral,
science-based nature of theFDA's typical decision-making
(11:14):
process.
It seemed like they were tryingto undermine it from the get-go
.
There was a whole operation todo that and basically it kind of
feels like to me, almost likeyou know.
You see press conferences likethat.
It's like advocates have a gunon the table.
It's like we're either going toyou know the gun is we're going
to legalize these substances atthe state level, everywhere and
totally defy medicine again,like we did with medical
(11:36):
marijuana, or you're going toapprove our product through your
FDA and screw the fact that wetotally screwed up the entire
clinical trial process.
Speaker 2 (11:44):
And this is just.
I'd say, this is the.
You know, I hate when thosenews anchors and pundits say I'm
just asking questions, I'm justasking questions, but I'm going
to pull one of those.
I'm just asking a question here.
Okay, folks, why why is it thatyou only see this type of stuff
, press conferences and bigstatements when it comes to
(12:06):
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 ofCongress who did this press
conference, why aren't they outon the steps, like, pushing for
more widespread access toOzempic?
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.
(12:26):
Or or like the alt, the newalzheimer's drug, right, like,
like.
Why don't you see?
Speaker 1 (12:31):
those you could argue not to get super legal here.
But you could argue that thesocietal benefit of ozempic you
know you think about that likeobesity is one of the top
factors for morbidities in thiscountry.
You could argue that the whole,like Congress, should take that
up as a serious issue.
I mean, I'm not an expert onOzempic and I'm not certainly
not an advocate for for takingany of these medicines for
(12:52):
obesity.
But, um, you know you couldargue, based on the societal
impact of of a substance likethat, that that would
potentially be worth time inCongress talking about.
Speaker 2 (13:02):
Well, the only person , the only person who talks
about it is Bernie Sanders, wholaunches investigations into why
it's so highly priced.
That's the only.
Speaker 1 (13:09):
That's the only thing that right he doesn't have
dozens of members of Congress.
Speaker 2 (13:15):
It's just interesting , right, like you, you see, you
never see.
You know why aren't they likeyou know, like drugs like, okay,
drugs like Advil or some like.
Why don't you see pressconferences about substance?
Obviously, that's been aroundfor 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 Ithink it's.
(13:35):
It's not my, my, my opinion isthat this is not a coincidence.
Speaker 1 (13:40):
Yes, and it's not a coincidence, and it's not even
just that's not even just astatement of opinion.
I mean, you look at Lycos as acompany.
They changed their name fromMAPS to kind of change the PR,
but they were a bunch ofpsychedelics, users and
activists I mean, doblin is awell-known psychedelics activist
and they were pushing this.
As you know.
They were trying to getscientific validation for their
(14:01):
wild claims they've made overdecades, and it didn't work out
because they tried to fudge thenumbers.
Now, all of this is not to saythat some of these substances
may not be approved by the FDAin the future.
I think there's a strong chancethe FDA very well might approve
these substances for medicinalpurposes in the future.
They certainly have indicatedthat they likely will.
(14:23):
The important piece of this,though, is to ensure the
predictability of these drugs,that they will have a
predictable effect on thepatients that are taking them,
and I think it's going to bevery hard to get them ultimately
approved.
There's a lot of excitementaround the potential, but you
still have a situation where andthere's a number of articles
that have come out just in thelast couple of days on you know,
(14:44):
veterans who had very adversereactions to some of these
psychedelic drugs being takenfor their PTSD.
So there's still the situationwhere one person takes this and
has, you know, a positiveoutcome, and another person
takes the exact same dose andhas an overwhelmingly negative
outcome, and then another personhas a violent outcome.
And so I think, you know, withmedicine they really tried, it's
(15:07):
just an.
There's a lot that goes into it, but predictability is a key
piece of this, and so I thinkit's gonna be very difficult,
but you know it may get approvedat some point and if it follows
through that process, great.
But you can't do that whereyou're putting patients at risk,
and that's what, unfortunately-.
Speaker 2 (15:21):
Also, I just like to say right, like when things get
approved by the FDA, I thinkpeople think that that's a huge
win and then everyone's justgoing to be able to do these
drugs.
Right Like there's a highlyregulated process.
It likely will only be able togo to a select group of people.
Right Like there are certain,like we mentioned, ozempic.
(15:41):
Right, they're kind of aloophole actually with Ozempic.
But Ozempic is technically onlysupposed to be used for people
with a certain type of diabetes.
Now everyone says it's theweight loss drug.
It's actually not supposed tobe used for that and there's a
loophole.
But I think these psychoactivedrugs will probably be even more
tightly regulated.
So it's not like just the nextday anyone who's feeling a
(16:03):
little off is all of a suddengoing to just be able to pop
ecstasy.
You know, that's not how thisis going to work either.
Speaker 1 (16:09):
Yeah, I have a sneaking suspicion we're going
to hear that.
Oh, it's still too hard forpeople to get access, like we
haven't heard that before wehave not Right.
Speaker 2 (16:19):
Oh yes, that's exactly right, it's all.
It's all a slippery, slipperyslope with this stuff.
Speaker 1 (16:24):
Correct, yeah, so I think it'll be important to.
If it's going to be medicine, Ithink the FDA wants to make
sure it's actually medicine andit's not something that's being
used nefariously, and I thinkthat's going to give companies
like Lycos and Doblin advocateslike Doblin a really hard time.
So all right.
Well, that concludes ourdiscussion of the FDA's decision
.
It's a giant decision.
It's one that we should takeheat of, following the science
(16:47):
when it comes to drug policy,not the hype.
The hype is just so ridiculousand when you put it to the test
so often, the hype is just.
You know.
When somebody tells yousomething is too good to be true
, like this drug heals andchanges everything, you know
it's likely it is too good to betrue.
So I think that's an importantthing.
So, jordan, thank you forjoining me.
Um to all of you, our listeners, please rate us five stars,
(17:08):
please leave us a nice review wealways appreciate that and have
a great rest of the week, thankyou.
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