February 14, 2025 • 42 mins
What if a single medication could revolutionize the treatment of thought disorder and psychosis? Join us as we invite Dr. David Pickar and the team he supports at Help in the Home back to the show to explore the potential of a new anti-psychotic medication approved by the FDA, Cobenfy. Setting itself apart by targeting the brain's cholinergic system and M1 and M4 receptors, Cobenfy sets a promising a new pathway for reduced side effects in antipsychotic treatment. We also discuss the FDA's pivotal move to relax restrictions on Clozapine, a decision that could reshape its role in mental health care and the med management challenges it has faced in the past.
From this springboard we dive into the sophisticated world of pharmaceutical innovation, focusing on the unique mechanisms behind anti-psychotics. We also shed light on the historical and financial intricacies of drug development, from the Hatch-Waxman Act to the current dynamics between pharmaceutical companies and the generic market. With the global antipsychotic market on the brink of expansion, we explore the delicate balance between groundbreaking medication R&D and the lived experience of those using these medications often for most of their adult lives. Join us for this enlightening episode that offers a candid look at the evolving landscape of mental health care.
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Episode Transcript
Available transcripts are automatically generated. Complete accuracy is not guaranteed.
Speaker 1 (00:00):
Hello folks, thanks for joining us on Head Inside
Mental Health, featuringconversations about mental
health and substance usetreatment, with experts from
across the country sharing theirthoughts and insights on the
world of behavioral health care,broadcasting on WPVM 1037, the
voice of Asheville independentcommercial-free radio.
I'm Todd Weatherly, your host,therapeutic consultant,
(00:21):
behavioral health expert,returning to the show with us
today, himself and severalguests, but Dr David Picard.
Dr Picard is adjunct professorof psychiatry at Johns Hopkins
Medical School and the UniformedServices University of the
Health Sciences.
He received his medical degreefrom Yale University School of
Medicine, completed hisresidency in psychiatry there.
(00:43):
Dr Picard has served on theNational Institute of Mental
Health as a USPHS commissionedofficer and captain and chief of
the experimental therapeuticsbranch, dedicated to the
studying of schizophrenia andpsychosis.
He also served on thepsychiatry drug advisory
committee for the FDA.
He is fellow emeritus of theAmerican College of
Neuropsychopharmacology and isdistinguished life fellow of the
(01:06):
American PsychiatricAssociation.
That's a mouthful in by itself.
Dr Picard participates inneuropsychiatric drug
development with emergingbiotechnology companies and has
served as a psychiatricconsultant to the US Special
Prosecutor.
He is also the founder andpresident of Gabriel Sciences, a
company whose mission isadvancing the development of
novel treatment forschizophrenia.
(01:27):
Dr Pekar has received numeroushonors and awards in the course
of his career, has co-authoredor co-authored over 400
publications and over 27,000citations in the field of
psychiatry and medicationresearch.
He is also the producer ofdocumentary film the Realities
of Serious Mental Illness.
Dr Picard practices psychiatryin Chevy Chase, maryland, with
(01:49):
emphasis on the care of patientssuffering from serious mental
illness, including clientsserved by MobileMed, a nonprofit
provider of care for some ofthe most vulnerable individuals
in the area, and our friends ofthe show Help in the Home
provided supported independentliving services.
There in Rockville, maryland.
Founders Rayette and MichaelStacey Derrick, as well as their
clinical outreach ShannonHarris, are joining us as well
(02:11):
today.
Everybody Dr Picard, welcomeback to the show.
Speaker 2 (02:15):
Thank you, todd, for having me.
You know I can't wait.
I enjoyed the last time so muchand I'm thrilled to be here
with Rayette St Stacy andShannon the folks from Help in
the Home who provide a prettyunique opportunity to help
families and patients who areseriously ill.
Speaker 1 (02:32):
Yeah, well, you know we talked a little bit about
this last time, but it's, youknow, being able to provide care
, residential treatment andhospital treatment is what it is
and it's got its place.
But the rubber meets the roadout there, where people try to
live independently again andreceive the services of folks
like Help in the Home and beingable to just maintain, you know,
(02:53):
these kind of fulfilling andsupported living lives is really
important, and if they don'thave that, they end up stumbling
and repeating cycles throughthe hospital and everything else
.
But one of the biggest piecesto that, of course, you know,
for me it's very important wherethe stumbling blocks have a
tendency to happen, we end upgetting involved because
somebody is going throughresidential treatment again or
(03:15):
whatever is med management, andsome of med management is people
who are resistant to meds, ormaybe they get to a place and
they stop taking them becausethey don't want them.
But another one is also findingthe right med.
We've got a lot of medicationsout there antipsychotics and
medications that serveindividuals suffering from
(03:36):
psychotic disorders or sufferingschizophrenia or
schizoaffective disorder and oneof the meds that we want to
talk about today is Cobenify.
No, no, I see I'm saying itwrong again.
Cobenify, is that right?
Tell me, you're gonna go there,we there, we go see I can I can
speak to them and change it ifyou'd like okay, yes, you know,
(04:00):
just just for me, because myaccent, but you know from
ashville, you call on anythingyou want in Asheville.
That's right.
We don't even care if it'sright.
See Well, Cobenfi, tell us alittle bit about this medication
, Dr Picard, and how we got here, your experience with it, your
thoughts about it.
Just give us the lay of theland.
Speaker 2 (04:20):
I'm glad to, and putting it into the context,
that seriously mentally illpatients and patients who have
psychosis in general and thatcould be manic patients, even
depressed patients, briefpsychotic episodes need
antipsychotic medication.
Yeah, and you know the firstwonder drug and I think pardon
me for backtracking a littlebecause I'm a bit old, you know
(04:43):
but the original antipsychoticsfell in the category of wonder
drugs, the way antibiotics didit.
It may not appreciate it, butup until then there was nothing
and these drugs were effectivein reducing psychosis.
They don't take away thedisease and they could get
better, and they've gottenbetter over the years.
But there's been quite a bit oftime before there's been an
introduction of a newanti-psychotic and that's what
(05:05):
CoBENF is, and it was approved.
But let me go just to give ourlisteners, our friends here, a
little perspective.
When I was at the NIH I did anoutside consultation for Eli
Lilly Company on a drug, tinylittle pharmaceutical firm,
(05:26):
right, you know, yeah, a smallone, a small one, right, right
mom and pop shop.
Okay, okay, um and uh.
Yeah, you got it and they askedme to look at this answer.
I'm talking about 30 years ago,25 years ago, and they asked me
to look at this compound theyhad developed and they had done
quite a few clinical trials andit did appear to be an
antipsychotic and that drug wasxenomaline, and xenomaline is
(05:50):
the name of the drug, that'sco-benthine.
Speaker 1 (05:53):
Oh.
Speaker 2 (05:54):
Okay, and this is 30 years ago.
It was ready to go.
Speaker 1 (05:57):
Right.
Speaker 2 (05:57):
But there was a problem, and I'm going to circle
back.
Everybody tell you more abouthow we use Cobenfi and why
people got excited and so forth,but it produced an array of
side effects that the companyfelt were prohibitive at that
point to moving the drug forward.
And the drug was taken over byan old colleague of mine, Steve
(06:17):
Paul, and he used to be one ofthe most senior people at Lilly,
but he brought it to his owncompany and what they did was
they added another drug to themix.
So when you get co-benthly it'stwo drugs and the second drug
takes away a lot of the sideeffects that were a problem as
opposed to having to findanother med which handles all
the side effects.
(06:39):
That's right.
It's exactly right, todd.
And the problem with that?
Because it's true with a lot ofantipsychotics that you need
anticholinergics, cogentin andso forth, to help with side
effects.
The side effects were sopronounced.
Certainly the company.
I can't speak, I'm not speakingfor Eli, but my observations
were that the company justdidn't feel this was going to
work.
You're going to turn off toomany people.
(07:01):
And when they added this otherdrug I'm going to come back to
it it's very nicely handled.
It's nicely handled in thesense that clinically it's a
very comfortable drug, maybemore than other antipsychotics.
That's right.
(07:22):
Another step to the side, if notquite back, the development of
antipsychotic drugs.
The first ones were in the 50s,60s.
It changed the world of mentalillness, blah, blah, blah, blah,
blah, blah.
And there are a lot ofexcellent ones.
The best one is still clozapine, which is developed, believe it
or not, in the 70s but requiresblood tests.
And I can certainly speak a lotabout clozapine, but the field
has not produced a drug that's alittle different in mechanism
(07:44):
in forever.
And Copenfi comes along andthere was an enormous enthusiasm
, as there should be, by peoplewho care for patients or
families or patients themselves,because it is a little
different mechanism which I'mgoing to talk about in a second.
So this was approved by the FDA.
I don't have the date in frontof me, but I'm going to say with
(08:05):
the last six months and I thinkyou can get it in most
pharmacies now, but it's justgetting out there, okay.
Speaker 1 (08:13):
I've got a quick question for you.
Speaker 2 (08:14):
Yeah, interrupt me please.
Speaker 1 (08:16):
Well, there was a recent FDA.
There was a case with Clozapineand the FDA and they were
trying to change some of therestrictions with Clozapine and
the FDA and they were trying tochange some of the restrictions.
It didn't make it, or the casewas continued or they're coming
back to court about it, butbasically people didn't get the
result that they wanted andwe're still facing a lot of what
(08:38):
ultimately are a pain in thebutt in terms of getting it
managed for a person, bloodtests and certified
psychiatrists to be able toprescribe it and all those
things.
It makes it difficult,especially for people who are
resistant to taking medications.
Was there and do you know or doyou think, that CoBENFI was
making its way down the line andthey didn't want Clozapine to
(09:00):
make any new developments or getgreater on the scene before
they were able to introduce thisnew bed?
Was there any politics there?
I?
Speaker 2 (09:08):
love you, todd, you're from North.
Carolina I can tell it.
You think there's some kind ofconspiracy going on there too
Right.
Who came in there with the gunsblazing?
In fact, you're giving themmore credit than they deserve.
Fair, but the point is welltaken.
Let me go back to a couple ofthings.
Clozapine, to this day, is themost effective antipsychotic.
It had a risk for losing whiteblood cells this goes way, way
(09:33):
back in my residency days and asa result, the FDA, food and
Drug Administration, requiresblood tests that are a pain in
the tuchus.
That's Yiddish for butt.
It's a pain in the butt and ithas, I believe, has limited the
utility of clozapine.
One thing you're not rightabout it went through.
They're taking away the REMs.
Speaker 1 (09:53):
So they are yes.
Speaker 2 (09:55):
Oh well, that's great actually, yeah it's great and
the reason it's fascinating.
A granulocytosis is the loss ofwhite blood cells, which is
life-threatening.
When they first did trials ofclozapine back in the 70s, one
country had a large number ofA-granulocytosis and that
country was Finland.
Now I think it's because manyFinnish people are not that
(10:15):
outgoing, but I could be wrongon that but I've never seen it
anywhere else.
But it has been an unfortunateside of the clozapine story and
now, with this change, you'regoing to see more of it.
Now, one of the things thatmade everybody excited about
Copenphi because there have beenother new drugs introduced, but
(10:36):
they've basically been I don'twant to use the term knockoffs,
that's not fair but very similarmechanisms and effectiveness.
Okay Right.
Speaker 1 (10:42):
It's not far off.
The mod, the, the originalmolecule, essentially one step
better.
Speaker 2 (10:47):
There was a second generation that started
clozapine as a whole thing untoitself, but risperidone, uh uh
uh, alanzapine okay, yeah, thosedrugs were considered the early
second generation drugs, hadless in the way of the motor
side effects and more effective,but they weren't the same as
clozapine and far from perfect.
(11:10):
Okay Right, this thing, thisdarn thing, is a very
interesting drug because it hasa different mechanism.
I love them.
I spent a lot of my lifelooking at mechanisms and
developing drugs and so forth.
So let me take a half a stepback.
It works through thecholinergic system.
Now hang on a second.
These are neurotransmitters.
(11:31):
Anybody out there does the termneurotransmitter mean anything?
If it bothers you, don't worryabout it, I'll get by it, you
know.
But these are the molecules thatenable one neuron, that's a
nerve cell, to talk to anotherneuron.
And frigging neurons livetogether by social, economic
status?
No, but they run together, theydo group, they do group, they
(11:55):
run together and create systemsof the brain that have different
mechanisms related to the brainand the dopaminergic systems,
meaning systems where the neuron, principal neurons of dopamine
uh, is a neurotransmitter havebeen the critical ones for us in
schizophrenia.
And they and why?
And I'm looking at everybodylistening out there, I'm looking
(12:16):
at todd's face and he's saying,hey, wait a minute, we're not
talking about clozapine, we'retalking about co-bemphi.
Get on the story.
Speaker 1 (12:22):
Well, I'm here, jack I mean I di I'm sorry yeah it
was your mistake.
It was you know.
Speaker 2 (12:27):
No, I'm teasing you because it's relevant, so bear
with it.
All known antipsychotic drugswork through either blocking
dopamine receptors or somehow,in the case of clozapine,
through a variety of mechanisms,modify it.
Now I used to say there's afamous Einstein quote that God
is subtle but not malicious.
(12:47):
Okay, if dopamine has nothingto do with schizophrenia, your
highness, that's malicious, allright.
So there's no question in mymind that it's involved.
In what way is it involved, anddo you need to deal with it
directly to produceantipsychotic effect?
Well, maybe not.
So here's this drug, invented20 odd years, 30 years ago,
(13:08):
whatever that hits acetylcholineneurons or cholinergic neurons,
and they have their own systemsin the brain and they have
their own mechanisms, includingthe parasympathetic autonomic
nervous system.
I'm sorry, but things thatcontrol heart rate and things in
your internal organs.
Speaker 1 (13:26):
Things you don't have to think about.
Speaker 2 (13:28):
Right, all right.
So okay, good.
How is that an antipsychotic?
Well, there are differentcholinergic receptors.
They hit the M1, that's the waythey call it, and the M4.
Okay, in the cortex.
Good, cortex is your high partof the brain.
We think psychosis comes fromdopamine dysregulation in some
of the deeper lower parts andthe cortex may sit on that and
(13:50):
quiet it down.
Just like in real life, yourconscious thoughts sometimes sit
on your unconscious thoughts incase you noticed, uh, the
cortex.
The old psychoanalysts talkedabout super ego, your sense of
conscious and your conscioussense of self, and it would
modulate it, which was youremotional self.
Well, guess what?
(14:11):
The cerebral cortex, theprefrontal cortex, modulates
deep subcortical systems likedopamine.
And so the analysts, in a funnyway, were not that wrong.
And so it's the corticalsystems that help to keep
dopamine systems in check, andwhen they're out of check with
the illness, you improve it anyway you can.
And by God, co-benthy, whichthey're bragging about being
(14:34):
muscarinic or cholinergic is theterm turns out to work by
quieting down dopamine systems,just by a different pathway.
So it's cholinergic ontodopamine, and it does it without
bonding to dopamine receptorsor causing some of the side
effects.
Now, is it as good as the greatdrugs like Clozapine?
(14:54):
We don't know yet, but there'sno question it's an
antipsychotic.
I'm going to tell you somethingelse Most antipsychotics
virtual are not pleasant.
I mean I when I say that.
I mean it's not that you can'tgive them away at a cocktail
party, but you have motor sideeffects that people feel them.
Speaker 1 (15:15):
Now they have tremendously long-term.
Speaker 2 (15:18):
Yeah, you know people don't like them and sometimes
as a psychiatrist, and you havesomebody who's lost touch with
reality.
Now he's back in reality andwants to go off his meds.
Sometimes out of reality feelsmore appealing than to reality.
To some of these folks who'vebeen ill, you know their lives
is not what it was.
Quote, quote intended to bestruggling Hell with it.
(15:39):
I'm stopping medicine At leastthey're my own head.
Happens a lot, a lot, not alittle, a lot, okay.
And the fact that thesetraditional antipsychotics, they
make you feel a little funny.
That's why we often give extradrugs to help side effects.
Well, one of the things thatstruck me most about Combenfi is
(16:00):
that, relatively speaking, it'svery well tolerated.
It's not principally adopaminergic drug.
It works on dopamine indirectly.
You with me.
It does acetylcholine thingsand guess what?
They're in the cortex, frontalcortex, and they drop down to
quiet dopamine indirectly andit's a much more pleasant
sensation in the body.
(16:20):
So one of the things I likeabout CoBed-3, that I like a lot
is that it's better tolerated.
Now, having said that, thecholinergic systems have some
bad side effects and I told youearly on when they were
developing the drug.
So the drug Cobenfi is theactive drug, zonomaline and
trospium, which isanticholinergic, to help the
(16:43):
side effects.
So in one pill they have a drugto help the side effects and
the active drug.
And in fact, when people takeCobenfi, my experience and when
you read from the controlleddata because that's all we've
had for a long time is from thedrug trials is that the patients
find it much more tolerable.
I love that.
I love that.
Now I, as an old scientist,clinical scientist, I have a
(17:08):
million questions I'd love toanswer.
Unfortunately I retired fromrunning that thing at the NIH,
but it's an interesting drug soit's very well tolerated.
A little bit of a differentmechanism.
It indirectly hits dopamine.
Okay, I like that.
Would it be helpful if youadded it to other antipsychotics
in patients who are not fullydoing?
Well?
Don't know the answer, but I'llbet it will.
(17:28):
I think you're it to anti,other anti-psychotics and
patients who are not fully doingwell, don't know the answer,
but I'll bet it will.
Right, I think you're going tosee in a lot of different
directions but a lot of peoplewho are medication resistant
might experience benefits that.
That is the traditional uh todd.
That's your traditionalindication for clozapine right
and if it were in my hand rightnow?
(17:48):
I know the company, I knowthese guys.
This is not a knock on thepharmaceutical industry, but
just a knock on thepharmaceutical industry.
They are I can't use that word.
They're nervous Nellies.
How about that?
For a benign term, okay, andthey don't like to.
If they, they have somethinggood, don't fool with it.
Um, but this drug should beused in a lot of different ways
(18:12):
until we fully understand itsbenefit yeah, but they're being
they're being driven by r&dsaying we need a new product, we
want something new.
Speaker 1 (18:18):
You know, like they have to find the difference
between those.
Those two uh influences, don'tthey?
Speaker 2 (18:23):
you got it and I was gonna.
I, I think people this but theanti-psychotic drug, the
pharmaceutical drug business, isa big business.
Among the drugs, theanti-psychotics are among their
highest revenue driven drugs.
In its peak, the drugRisperidone probably earned
about $5 billion a year billiona year.
Speaker 1 (18:51):
Well, I mean, you know, it's no secret that
pharmaceutical companies reallylike it when you get on a
medication you have to take forthe rest of your life.
Speaker 2 (18:55):
You got it and the only thing you know, the only
things the pharmaceuticalindustry does not like, as you
may know, is the fact thatthere's a patent law and once it
goes off patent, other peoplecan do generics they can do
generics, they can do generics,yeah, they can take it away I
don't know, I mean dad, I don'tknow how familiar I with drug
development, but it's afascinating thing.
It's a it's called hatch waxmanlaw that did that.
(19:16):
Hatch was orrin, hatch goodrepublican, and waxman was a
congressman he was a senatororrin and waxman was a
congressman from that jewishcongressman from mass, and they
created a law.
They both had things theywanted and so they let the
pharmaceutical industry get somemore protection on certain
(19:37):
things.
That was a hatch and Waxmaninsisted that once the drug is
off patent, all the informationon that drug can go to generic
manufacturers.
Off patent, all the informationon that drug can go to generic
manufacturers so that once it'sdone I can take everything from
the FDA and now make the drugmyself.
Speaker 1 (19:57):
Before that you have to do all that stuff yourself.
A little anti-monopolizationkind of stuff.
Speaker 2 (19:59):
Correct.
That's right, todd, and thatcreated the generic business.
Generic was not a businessbefore that.
How about that?
You know, I'm sorry, I'mrambling, you stopped me.
Speaker 1 (20:13):
No, I the I want you rambling is makes great show.
Speaker 2 (20:22):
I'm just sorry that I can't speak to the audience and
hear what they'd like to say.
I like that.
Speaker 1 (20:26):
Maybe someday we'll me give you We'll get a live
show going at some point in time.
No, go ahead what you got hereyou go, todd.
Speaker 2 (20:34):
The worldwide anti-psychotic drug market is
expected to grow from about$14.5 billion right now to $26
billion by 2032.
So this is a big market andit's now a large generic market
too.
So the pharmaceutical industryis very sensitive to not fooling
(20:55):
around with what they had, Iknow in my working in drug
development.
But this one sort of snuckthrough got out and has given a
lot of enthusiasm and positivevibe to our community.
Speaker 1 (21:07):
Like you say, but it's got.
You know you're talking.
We're talking about a new medthat's already got 25 years
worth of development on it,which is, you know, it's mind
boggling a little bit, but it is.
Speaker 2 (21:18):
When it came out, todd, I was away from that for a
bit.
I was taken back when I saw Ihadn't realized my old buddies
were developing it again and Ismiled to myself.
And by God, it's a goodantipsychotic.
They added this other drug toit so the side effects were less
and they did a nice job.
(21:39):
Steve.
Paul did a nice job on it, butyou're right and there's got to
be more Me I'm always thinking,but I like the mechanism of
indirectly softening ormodulating dopamine transmission
and I didn't think of it thatway.
The people literally weren'tsmart enough, but that's what it
does and that's what it doesand I love it.
Speaker 1 (21:57):
No, I'd love to.
I've got a theory that I would,that you, we, I've got a crew
here that is very qualified totell me that I'm 100% wrong or I
might be onto something or Ineed to give up my career in
behavioral health care and sopossibly Stacy Rayetta or
(22:19):
Shannon want to pitch in.
But I work with families prettyregularly.
I ended up giving some.
The family was faced with anindividual.
He was suffering from psychoticfeatures.
It was new to him.
He was in that kind of firstepisode category.
Families also don't knowanything about this.
(22:40):
All of a sudden they're facedwith a family member who's got
psychosis in their profile, etc,etc.
The whole thing.
They're just trying to get asmuch information.
I ended up having to call withthem.
I actually we did a record ofthe call.
I went back to the script thatit.
You know the notes that gettaken, and I made a blog out of
it.
Like, look for the you know,for the layperson, the person
(23:01):
out there who's really trying tofigure this out.
There are a couple of differentways that psychosis occurs for a
person.
Diagnosis aside, you've got aperson who suffers from thought
disorder, it's got psychoticfeatures, and they may be
experiencing psychosis as aresult of drug use.
But the chances are good it waslatent and they're going to
(23:22):
suffer from psychosis for therest of their life and they need
an antipsychotic.
You've got people who areliving in this category and
we're finding them these daysthat suffer from a psychotic
episode as a result of drug useand if you take the drugs away
they don't have psychosisanymore.
And we're seeing these folks.
They're out there but they'vegot to be really careful about
(23:46):
what they put in their body.
And then you've got people whosuffer from pretty serious mood
disorder, bipolar disorder oreven psychotic depression and
those kinds of things.
And the meds differentiate alot of times in these two kinds
of categories.
Because a person who suffersfrom mood disorder let's say
it's mania, let's say it'sdepressive or maybe they
experience both at high levelsbut if they go over a threshold
(24:07):
on the mood whether manic'sdepressive or maybe they
experience both at high levelsbut if they go over a threshold
on the mood, whether manic ordepressive, once they go past
that threshold they start tohave thought disorder and they
can even have a psychotic break.
Sometimes you can give one ofthese people, a person who's
suffering from a condition likethis a mood stabilizer without
(24:29):
an antipsychotic and so long asthey've got a pretty decent diet
, they're taking care ofthemselves and they're getting
sleep and they're on a moodregulator, they never pop over
the threshold and experiencepsychosis, whether it's high or
low, and they may be able to getaway with not having an
antipsychotic on board.
And it basically makes threecategories of people suffering
(24:52):
from psychosis and the variousways they get treated.
That's a dumbed-down way ofexplaining it to folks who are
faced with this for the firsttime, but it was approachable.
Would you add anything to that?
Am I completely off and whatwould you add?
Speaker 2 (25:08):
Todd, I would never say you're completely off you'd
be among the first dr the wordswe use in jersey.
I can't say you understand whatI'm saying.
I do, okay, I don't.
I don't know if anybody outthere can hear my jersey accent.
I haven't lived there sincesince I graduated from college.
I'd just like to call it home.
(25:29):
I'm teasing you.
I'm teasing you.
Psychosis means loss of touchwith reality, often shown by
delusions.
Delusion is a false belief,todd, and I know many of your
people out there know that.
But just for clarity, so afalse belief might say the FBI
is after me, but it's not true.
(25:50):
Or that person over there meansme harm.
Those are paranoid kind ofthings.
They're not bizarre becauseit's possible the fbi is after
me, they're just not there's.
Speaker 1 (26:03):
Because you're paranoid doesn't mean they're
not after you.
Yeah okay.
Speaker 2 (26:06):
But then there's what's called bizarre delusions.
So when I talk about alienscontrolling or reading your mind
or you putting thoughts in myhead, that can't happen and
those are mostly characteristicof patients who have
schizophrenia, okay, and bizarredelusions.
And some folks are required notjust delusions, but bizarre
(26:27):
delusions, now losing touch withreality.
Ie, psychosis occurs in a lotof different disorders,
including depression, thedepressive psychosis, just what
you were talking about usuallyhave a globality about how
depressed you are or about howit's awful for your children
that I'm staying alive, and itdoesn't mean just schizophrenia.
I was just reviewing a case I'mwriting about in my book for a
(26:48):
patient who had severepostpartum psychosis.
One of the strangest psychosis,most deadly psychosis, are
psychosis that typically occurthe postpartum blues or sadness
having given birth pretty commonafter the first two or three
weeks, but a month later, whenpeople start getting depressed
and they get globally depressed.
(27:09):
And this particular woman cutherself all over her body with a
one-month-old child at home andyou read them.
We all hear about these.
People kill infants and soforth and that's psychosis in a
postpartum state.
Which is pretty, which is bad?
No question bipolar, a bipolarpsychosis.
You want to see grandiosity.
(27:30):
So not only am I dealing notwith reality, I want you to know
okay that Julius.
Speaker 1 (27:36):
Beezer is nothing compared to me Right, I'm the
greatest rapper that ever lived.
Speaker 2 (27:40):
You got it, you got it, and that's how I say I'm a
doctor.
No, that's not, it's a joke.
It's a joke.
I don't just play one on TV,I'm a real guy.
All kidding aside, it'sinteresting, todd, that you
mentioned it.
When I was training and then,when I started becoming a
scientist, I came to the UnitedStates.
I always loved psychosis and itsounds funky because I don't
(28:02):
know why I liked sick peoplewhen I did internal medicine for
a year after medical school andthe psychosis is a
characteristic of our more illpeople.
Now, the people who haveschizophrenia have psychosis,
but they gosh darn it, todd.
They also have flatness ofaffect.
They don't express themselveswell um.
Speaker 1 (28:22):
They pick up on social cues.
Speaker 2 (28:23):
Well, they look like they've got on the spectrum and
they have and and they have, uh,executive function difficulties
.
You know it's a tough one.
So if there's any folks outthere listening to us who have
family members who haveschizophrenia, you know these
things, the so-called negativesymptoms.
You know these things, theso-called negative symptoms,
things they don't have, and theso-called positive things that
they have that shouldn't bethere voices and so forth and so
(28:45):
on.
And I've been around medicineand psychiatry a long time, but
that illness, to this day Ithink about it and how hard it
is for the families.
And I don't know if there's anyfamilies out there listening to
us today who are working withkids who have the illness.
Speaker 1 (29:03):
For certain.
Speaker 2 (29:04):
Yeah, and let me say something parenthetically on
that.
When I meet a new family and soforth, one of the things I like
to do when I get to know them,todd, is if they have a, a
sibling, I like to bring in thesibling and chat with, not to
find oh, I'm going to findsecret information.
No, no, no, no.
The siblings have a very toughtime and they, in other words,
(29:29):
they got a brother or sisterwho's very ill.
It takes a tremendous amount ofyour mom and dad's time.
There's just so much oxygen inthe room you can, at one level,
resent that you're not gettingthe attention and then you say,
holy mackerel, I can't resentthat.
My, my sister's so sick theserious illness right yeah, you
know I don't.
That's not me, of course theyshould, but they feel it and
(29:52):
when I bring guys in and gals, Ilike to tell them thank you and
I say to them thank you, that'scool I always do it because I
said you know you're doing whatyou're doing to be a good
sibling and caring about him.
But I know it's hard, and it'shard maybe hard for your parents
to step aside and takethemselves away from your ill
brother.
But let me tell you, thank you,because I know by being
(30:14):
yourself, by caring about thefamily and going on with your
life productively is a hugething, and it's made difficult
because you have a sibling, notas bad as him or her, but it's
tough.
And so I'm just pulling youaside to let you know, as a
shrink, I know what you gothrough, not specifically, but I
know it's hard and thank you,you're doing it for your brother
and your whole family.
Speaker 1 (30:35):
Well, and it's not just hard for that moment, it's
hard for a lifetime, you know,for for so many, which is why
you know we're pretty helpful.
We're super grateful for thework that you know helping the
home and you're doing with thesefolks to help them find kind of
long-term care solutions.
I'm curious yeah about.
I'm curious about um, if you're, you know, just to circle it
(30:57):
back around, are you seeing theresults of CoBENFI in the
populations that you serve rightnow?
Speaker 2 (31:06):
It's just getting Todd, it's just getting out.
So when we can reconvene thissession a few months from now,
I'll have a better feel for it.
Speaker 1 (31:14):
Yeah, let's see.
You know, we should pick it upnext year and figure out what
you're seeing there it'sinteresting.
Speaker 2 (31:20):
Okay now.
So the drug was from lily.
Sorry, sorry to talk like thisis the market week.
Okay, so the drug was from lily.
They let it sit there.
The former most senior medicalperson at lily formed a small
company that licensed it out.
That was my, my buddy.
Speaker 1 (31:36):
Oh wow, and fixed it up.
Speaker 2 (31:40):
Steve Paul, and Steve is very sharp and he likes to
invent new blah, blah, blah,blah blah.
So they licensed it.
Then what they did?
They made sure they had theaddition of this other drug to
fight the side effects and thenthey just sold it to Bristol
Myers about a month ago, twomonths ago.
Bristol Myers is one of thelarge pharmaceuticals, or we
(32:00):
used to call it Big Pharma, andsometimes when I say Big Pharma,
people are listening and theysay did you say Pig Pharma?
No, no, big Pharma.
Speaker 1 (32:10):
Though they've been interchanged, I'm sure.
Speaker 2 (32:13):
I've had many people say what does Pig Pharma have to
do with it?
I say no, it's Big Pharma.
Speaker 1 (32:23):
Now it's controlled by Bristol Myers, which hasn't
had a good psychiatric drug in abit and they'll do a nice job
marketing it Now it's-.
I bet Eli Lilly is very happyabout the fact that Bristol
Myers got it.
Speaker 2 (32:28):
I haven't had the opportunity to look at the
contract, but you know they'reparticipating in some of the
benefits.
Yeah, sure, the way it's donedone, but it's an interesting,
complex business, so we'll seewhere come benfi does.
I I'm after those guys a littlebit to do these other things
about it that I'd like to seedone, but that's another.
That's another uh question.
(32:48):
I'm going to call steve one ofthese days and have a chat with
him on that.
Speaker 1 (32:52):
So one thing I'll ask about cobenfi that I I think it
is is I'm curious about to seeif it's an effect.
I don't know if you have athoughts about this but, um,
when you see people who aresuffered from long-term
psychosis, uh, and you know,maybe they've, they've done,
they've done the med gauntlet,they've been on everything under
(33:13):
the sun and you know they maynot have what we would call a
full psychotic break, but theyhave persistent delusions.
My parents I've got a clientright now.
This individual, he attackedhis parents which is for people
who know about psychosis andschizophrenia attacking a family
(33:36):
member is pretty common,unfortunately but attack his
parents because they were aliens, right, and despite the fact
that he's been in care for quitea while now and actually doing
pretty well, still maintainsthis persistent delusion.
His parents are aliens and theystill can't have a conversation
with one another.
And they still can't have aconversation with one another.
(34:00):
Will you think that this drugor this complement of drugs in
one pill will have any betterimpact on these persistent
delusional features thataccompany individuals suffering
from psychosis, especially ifthey have schizophrenia?
Do you think it's going to havea little better reach into some
of the symptomology?
Speaker 2 (34:22):
Todd, that's a great question at many levels.
I can circle around and do that.
Speaker 1 (34:27):
You know, I like to ask a good question, you know.
Speaker 2 (34:30):
Yeah, I was.
No, no, it's an interesting one, one that I've had more than a
little experience with, becausesometimes, when they don't
believe their parents are angry,they also go feel that way
about their doctor, which is meright.
He was obvi, and we'll comeback to the violence associated
with this illness and thedangers of it, and it's real.
Next, do I think co-benthywould help with those people?
(34:50):
Now you're asking me as ascientist.
See, I would love to see aclinical trial and I'd like to
see it alone, with these folksand in combination with another
anti-psychotic, to address thatquestion.
Now let me tell you somethingindustry doesn't love those kind
of studies, do you know why?
Because if something goes wrongor it's negative, they don't
(35:11):
want to hear it.
Okay, I?
want to know the money yeah, Iwant to know the answer.
So if it's negative, okay, welook at it this way.
Negatives are important, alwaysare.
So it's slow to get going to doit Now.
With the current situation thatwe all know in terms of the
attitude towards government andgovernment funding, with the
(35:31):
current administration, how muchmoney there's going to be to do
trials like that, supported bythe government.
I truly don't know.
I have no idea.
In the past you would see some,but it's a great question.
You know, todd, you would haveloved being with us for 20 odd
years.
I was at the NIH for 23 yearsand we were in what was called
the Intramural Research Program.
(35:53):
So the National Institutes ofHealth and National Institute of
Mental Health, which is one ofthose institutes, has what's
called an intramural and anextramural program.
Extramural are all theuniversities where I give grants
to them or trials I'm settingup and I want people to
participate in, and that's thelargest amount of money these
(36:13):
days that's spent.
The original part of theprogram was the intramural
program, which is what I waspart of and what has made the
NIH famous, and the intramuralprogram is where you have
scientists on board right hereI'm pointing to the clinical
center about three miles fromwhere I'm pointing and the
clinical center on the NIHcampus, and that's where we
would run these things and youwould have funded research, not
(36:36):
grants.
You'd have a certain fundingfor a year and they would review
your work every few years veryaggressively.
But I didn't have to have thingsapproved.
They trusted me as a scientistand there were scientific
reviews, all sorts of thingslike that, but it gave you the
freedom to do your own.
The most famous discoveriesfrom the NIH broadly come from
the intramural program and I'llgive you one, just not to derail
(37:01):
too much.
But I've been thinking aboutthe intramural program because
it was my home for quite a fewyears.
And, of course of now, what'shappening in government.
And I give the example of theNational Cancer Institute, which
is one of the institutes.
It's part of the NIH butactually has a direct funding
right from Congress.
It's huge Now, when I was thereall those years, one of the
(37:24):
things I respected and likedabout the NCI National Cancer
Institute they always hadpatients real life even though
they did a lot of lab work and Iwas fascinated my years because
the drugs they were using werenot dissimilar to what I used in
medical school in my internshipand nothing new had come.
And then about, I don't know,15, 12 years ago 15 years ago,
(37:47):
time fast Steve Rosenberg, whomI knew, developed the first drug
for melanoma and that was amonoclonal antibody type
approach, and it was enormouslysuccessful.
Melanoma was not a deathsentence, but it was wholly
different.
Speaker 1 (38:04):
It was bad yeah.
Speaker 2 (38:05):
Bad and that one finding has rocketed anti-cancer
treatments using some of thosesame mechanisms enormously.
Now I mention it for thefollowing reason I'm going to
bring it home to us who careabout mentally ill people.
At the present time there areno patients with schizophrenia.
In the NIH Clinical Center Iran a ward that had 10, 12
(38:28):
patients who were there formonths at a time, drug-free.
We managed them and StElizabeth's had a research arm
that would run from NIH.
There are none of them.
No patients, none, zero.
And that's another conversationand it's about genomics and
it's about science and it'sabout trouble for us In
psychiatry.
(38:48):
We care for men.
Do we need more trouble?
Now this came along so I haveno idea what's going on.
Now I'm not going to say nowise-ass cracks, but it's
interesting.
It's a fascinating time to livethrough.
But the clinical center and theintramural research program was
the hallmark of mostParkinson's disease and the use
(39:10):
of dopaminergic agonists camefrom that came from there.
It goes on and on and on.
Speaker 1 (39:15):
One of the biggest treatment modalities we've got
for Parkinson's right.
Speaker 2 (39:18):
Yeah, right, so I'm just saying that it was a unique
setting.
Universities wanted their money.
Everybody there wanted theirmoney.
Musk and Trump doesn't likethem giving out money, but the
universities, they have theirown congressmen, and so it
started in mental health.
It was genomics are going totell us everything we need to
know.
We don't need patients and it'sbeen one of the saddest
(39:41):
developments, but that's aconversation for another time.
Speaker 1 (39:44):
Todd, yeah, studying humans through chemistry labs
yeah, it's an interesting kindof proposal.
Speaker 2 (39:50):
Yeah, Genomics is a tool to help study people To
them.
People are a tool to help studypeople to them.
People are a tool to help studygenomics.
Capisce.
Speaker 1 (40:03):
Yeah.
Speaker 2 (40:04):
And that's what the story.
If I had to say it in onesentence, that's it.
Speaker 1 (40:07):
I'm not saying I'm not excited about the study of
genomics, like I think it'sfascinating stuff and I think
it's got real potential, butyou're going to need human
beings.
Speaker 2 (40:17):
And that's the purpose of it.
And that's the purpose of it.
And that's the purpose of it isto help people right, and they
lost that track.
I'm telling you, they want tohelp people in a theoretical way
, and then yeah, they lost theirarms length way yeah, they lost
their, but it came at theexpense of patients and that's
the.
That's the thing.
When that first came and I gota kick out of it, I felt like I
was in in putting a dunce cap on.
(40:39):
In China they make allacademics put you're dumb.
If you were an academic, well,if you were interested directly
in patient science, they'd put afigurative dunce cap on you.
You're not smart, you should bein genomics in the lab, and it
was a very strange change thatoccurred during my last some
years at the NIH.
(41:00):
I've been out for quite a while.
I still get calls fromreporters because those meetings
were all documented.
And when one of these drugsthat we were talking about then
is now having trouble in thereal world because it got
approved.
And then they look at thereporting.
You always see Dave Picardsaying something funny.
So I get calls.
I'm not sure the senior FDApeople love me as much as I
(41:23):
deserved, but anyway, that'sanother story.
We can put that on anothertopic.
It's part of the drugdevelopment situation.
Speaker 1 (41:31):
Well, it seems like we've got several topics,
including Cabin Fee, to followup on a little later on to see
where it's going to see what newdevelopments happen and what's
happened on the national levelwith funding for mental health
care and those kinds of things.
I'll be excited.
Dr Picard, you're alwayswelcome to the show.
It's just a blast to have youon.
Stacey Rayetta Shannon, I knowyou know Dr Picard.
(41:55):
He has a lot to say, so Iappreciate you joining us.
Just the same.
We'll talk a little bit moreabout how it lands on the road
out there with helping the home,but this has been Head Inside
Mental Health on WPBM 1037, thevoice of Asheville, Todd
Weatherly, your host, dr Picard.
Stacey Rayada Shannon, thankyou for being on the show again.
Speaker 2 (42:16):
Thank you, man.
Hello folks, thanks for joining us on Head Inside
Mental Health, featuringconversations about mental
health and substance usetreatment, with experts from
across the country sharing theirthoughts and insights on the
world of behavioral health care,broadcasting on WPVM 1037, the
voice of Asheville independentcommercial-free radio.
I'm Todd Weatherly, your host,therapeutic consultant,
(00:21):
behavioral health expert,returning to the show with us
today, himself and severalguests, but Dr David Picard.
Dr Picard is adjunct professorof psychiatry at Johns Hopkins
Medical School and the UniformedServices University of the
Health Sciences.
He received his medical degreefrom Yale University School of
Medicine, completed hisresidency in psychiatry there.
(00:43):
Dr Picard has served on theNational Institute of Mental
Health as a USPHS commissionedofficer and captain and chief of
the experimental therapeuticsbranch, dedicated to the
studying of schizophrenia andpsychosis.
He also served on thepsychiatry drug advisory
committee for the FDA.
He is fellow emeritus of theAmerican College of
Neuropsychopharmacology and isdistinguished life fellow of the
(01:06):
American PsychiatricAssociation.
That's a mouthful in by itself.
Dr Picard participates inneuropsychiatric drug
development with emergingbiotechnology companies and has
served as a psychiatricconsultant to the US Special
Prosecutor.
He is also the founder andpresident of Gabriel Sciences, a
company whose mission isadvancing the development of
novel treatment forschizophrenia.
(01:27):
Dr Pekar has received numeroushonors and awards in the course
of his career, has co-authoredor co-authored over 400
publications and over 27,000citations in the field of
psychiatry and medicationresearch.
He is also the producer ofdocumentary film the Realities
of Serious Mental Illness.
Dr Picard practices psychiatryin Chevy Chase, maryland, with
(01:49):
emphasis on the care of patientssuffering from serious mental
illness, including clientsserved by MobileMed, a nonprofit
provider of care for some ofthe most vulnerable individuals
in the area, and our friends ofthe show Help in the Home
provided supported independentliving services.
There in Rockville, maryland.
Founders Rayette and MichaelStacey Derrick, as well as their
clinical outreach ShannonHarris, are joining us as well
(02:11):
today.
Everybody Dr Picard, welcomeback to the show.
Speaker 2 (02:15):
Thank you, todd, for having me.
You know I can't wait.
I enjoyed the last time so muchand I'm thrilled to be here
with Rayette St Stacy andShannon the folks from Help in
the Home who provide a prettyunique opportunity to help
families and patients who areseriously ill.
Speaker 1 (02:32):
Yeah, well, you know we talked a little bit about
this last time, but it's, youknow, being able to provide care
, residential treatment andhospital treatment is what it is
and it's got its place.
But the rubber meets the roadout there, where people try to
live independently again andreceive the services of folks
like Help in the Home and beingable to just maintain, you know,
(02:53):
these kind of fulfilling andsupported living lives is really
important, and if they don'thave that, they end up stumbling
and repeating cycles throughthe hospital and everything else
.
But one of the biggest piecesto that, of course, you know,
for me it's very important wherethe stumbling blocks have a
tendency to happen, we end upgetting involved because
somebody is going throughresidential treatment again or
(03:15):
whatever is med management, andsome of med management is people
who are resistant to meds, ormaybe they get to a place and
they stop taking them becausethey don't want them.
But another one is also findingthe right med.
We've got a lot of medicationsout there antipsychotics and
medications that serveindividuals suffering from
(03:36):
psychotic disorders or sufferingschizophrenia or
schizoaffective disorder and oneof the meds that we want to
talk about today is Cobenify.
No, no, I see I'm saying itwrong again.
Cobenify, is that right?
Tell me, you're gonna go there,we there, we go see I can I can
speak to them and change it ifyou'd like okay, yes, you know,
(04:00):
just just for me, because myaccent, but you know from
ashville, you call on anythingyou want in Asheville.
That's right.
We don't even care if it'sright.
See Well, Cobenfi, tell us alittle bit about this medication
, Dr Picard, and how we got here, your experience with it, your
thoughts about it.
Just give us the lay of theland.
Speaker 2 (04:20):
I'm glad to, and putting it into the context,
that seriously mentally illpatients and patients who have
psychosis in general and thatcould be manic patients, even
depressed patients, briefpsychotic episodes need
antipsychotic medication.
Yeah, and you know the firstwonder drug and I think pardon
me for backtracking a littlebecause I'm a bit old, you know
(04:43):
but the original antipsychoticsfell in the category of wonder
drugs, the way antibiotics didit.
It may not appreciate it, butup until then there was nothing
and these drugs were effectivein reducing psychosis.
They don't take away thedisease and they could get
better, and they've gottenbetter over the years.
But there's been quite a bit oftime before there's been an
introduction of a newanti-psychotic and that's what
(05:05):
CoBENF is, and it was approved.
But let me go just to give ourlisteners, our friends here, a
little perspective.
When I was at the NIH I did anoutside consultation for Eli
Lilly Company on a drug, tinylittle pharmaceutical firm,
(05:26):
right, you know, yeah, a smallone, a small one, right, right
mom and pop shop.
Okay, okay, um and uh.
Yeah, you got it and they askedme to look at this answer.
I'm talking about 30 years ago,25 years ago, and they asked me
to look at this compound theyhad developed and they had done
quite a few clinical trials andit did appear to be an
antipsychotic and that drug wasxenomaline, and xenomaline is
(05:50):
the name of the drug, that'sco-benthine.
Speaker 1 (05:53):
Oh.
Speaker 2 (05:54):
Okay, and this is 30 years ago.
It was ready to go.
Speaker 1 (05:57):
Right.
Speaker 2 (05:57):
But there was a problem, and I'm going to circle
back.
Everybody tell you more abouthow we use Cobenfi and why
people got excited and so forth,but it produced an array of
side effects that the companyfelt were prohibitive at that
point to moving the drug forward.
And the drug was taken over byan old colleague of mine, Steve
(06:17):
Paul, and he used to be one ofthe most senior people at Lilly,
but he brought it to his owncompany and what they did was
they added another drug to themix.
So when you get co-benthly it'stwo drugs and the second drug
takes away a lot of the sideeffects that were a problem as
opposed to having to findanother med which handles all
the side effects.
(06:39):
That's right.
It's exactly right, todd.
And the problem with that?
Because it's true with a lot ofantipsychotics that you need
anticholinergics, cogentin andso forth, to help with side
effects.
The side effects were sopronounced.
Certainly the company.
I can't speak, I'm not speakingfor Eli, but my observations
were that the company justdidn't feel this was going to
work.
You're going to turn off toomany people.
(07:01):
And when they added this otherdrug I'm going to come back to
it it's very nicely handled.
It's nicely handled in thesense that clinically it's a
very comfortable drug, maybemore than other antipsychotics.
That's right.
(07:22):
Another step to the side, if notquite back, the development of
antipsychotic drugs.
The first ones were in the 50s,60s.
It changed the world of mentalillness, blah, blah, blah, blah,
blah, blah.
And there are a lot ofexcellent ones.
The best one is still clozapine, which is developed, believe it
or not, in the 70s but requiresblood tests.
And I can certainly speak a lotabout clozapine, but the field
has not produced a drug that's alittle different in mechanism
(07:44):
in forever.
And Copenfi comes along andthere was an enormous enthusiasm
, as there should be, by peoplewho care for patients or
families or patients themselves,because it is a little
different mechanism which I'mgoing to talk about in a second.
So this was approved by the FDA.
I don't have the date in frontof me, but I'm going to say with
(08:05):
the last six months and I thinkyou can get it in most
pharmacies now, but it's justgetting out there, okay.
Speaker 1 (08:13):
I've got a quick question for you.
Speaker 2 (08:14):
Yeah, interrupt me please.
Speaker 1 (08:16):
Well, there was a recent FDA.
There was a case with Clozapineand the FDA and they were
trying to change some of therestrictions with Clozapine and
the FDA and they were trying tochange some of the restrictions.
It didn't make it, or the casewas continued or they're coming
back to court about it, butbasically people didn't get the
result that they wanted andwe're still facing a lot of what
(08:38):
ultimately are a pain in thebutt in terms of getting it
managed for a person, bloodtests and certified
psychiatrists to be able toprescribe it and all those
things.
It makes it difficult,especially for people who are
resistant to taking medications.
Was there and do you know or doyou think, that CoBENFI was
making its way down the line andthey didn't want Clozapine to
(09:00):
make any new developments or getgreater on the scene before
they were able to introduce thisnew bed?
Was there any politics there?
I?
Speaker 2 (09:08):
love you, todd, you're from North.
Carolina I can tell it.
You think there's some kind ofconspiracy going on there too
Right.
Who came in there with the gunsblazing?
In fact, you're giving themmore credit than they deserve.
Fair, but the point is welltaken.
Let me go back to a couple ofthings.
Clozapine, to this day, is themost effective antipsychotic.
It had a risk for losing whiteblood cells this goes way, way
(09:33):
back in my residency days and asa result, the FDA, food and
Drug Administration, requiresblood tests that are a pain in
the tuchus.
That's Yiddish for butt.
It's a pain in the butt and ithas, I believe, has limited the
utility of clozapine.
One thing you're not rightabout it went through.
They're taking away the REMs.
Speaker 1 (09:53):
So they are yes.
Speaker 2 (09:55):
Oh well, that's great actually, yeah it's great and
the reason it's fascinating.
A granulocytosis is the loss ofwhite blood cells, which is
life-threatening.
When they first did trials ofclozapine back in the 70s, one
country had a large number ofA-granulocytosis and that
country was Finland.
Now I think it's because manyFinnish people are not that
(10:15):
outgoing, but I could be wrongon that but I've never seen it
anywhere else.
But it has been an unfortunateside of the clozapine story and
now, with this change, you'regoing to see more of it.
Now, one of the things thatmade everybody excited about
Copenphi because there have beenother new drugs introduced, but
(10:36):
they've basically been I don'twant to use the term knockoffs,
that's not fair but very similarmechanisms and effectiveness.
Okay Right.
Speaker 1 (10:42):
It's not far off.
The mod, the, the originalmolecule, essentially one step
better.
Speaker 2 (10:47):
There was a second generation that started
clozapine as a whole thing untoitself, but risperidone, uh uh
uh, alanzapine okay, yeah, thosedrugs were considered the early
second generation drugs, hadless in the way of the motor
side effects and more effective,but they weren't the same as
clozapine and far from perfect.
(11:10):
Okay Right, this thing, thisdarn thing, is a very
interesting drug because it hasa different mechanism.
I love them.
I spent a lot of my lifelooking at mechanisms and
developing drugs and so forth.
So let me take a half a stepback.
It works through thecholinergic system.
Now hang on a second.
These are neurotransmitters.
(11:31):
Anybody out there does the termneurotransmitter mean anything?
If it bothers you, don't worryabout it, I'll get by it, you
know.
But these are the molecules thatenable one neuron, that's a
nerve cell, to talk to anotherneuron.
And frigging neurons livetogether by social, economic
status?
No, but they run together, theydo group, they do group, they
(11:55):
run together and create systemsof the brain that have different
mechanisms related to the brainand the dopaminergic systems,
meaning systems where the neuron, principal neurons of dopamine
uh, is a neurotransmitter havebeen the critical ones for us in
schizophrenia.
And they and why?
And I'm looking at everybodylistening out there, I'm looking
(12:16):
at todd's face and he's saying,hey, wait a minute, we're not
talking about clozapine, we'retalking about co-bemphi.
Get on the story.
Speaker 1 (12:22):
Well, I'm here, jack I mean I di I'm sorry yeah it
was your mistake.
It was you know.
Speaker 2 (12:27):
No, I'm teasing you because it's relevant, so bear
with it.
All known antipsychotic drugswork through either blocking
dopamine receptors or somehow,in the case of clozapine,
through a variety of mechanisms,modify it.
Now I used to say there's afamous Einstein quote that God
is subtle but not malicious.
(12:47):
Okay, if dopamine has nothingto do with schizophrenia, your
highness, that's malicious, allright.
So there's no question in mymind that it's involved.
In what way is it involved, anddo you need to deal with it
directly to produceantipsychotic effect?
Well, maybe not.
So here's this drug, invented20 odd years, 30 years ago,
(13:08):
whatever that hits acetylcholineneurons or cholinergic neurons,
and they have their own systemsin the brain and they have
their own mechanisms, includingthe parasympathetic autonomic
nervous system.
I'm sorry, but things thatcontrol heart rate and things in
your internal organs.
Speaker 1 (13:26):
Things you don't have to think about.
Speaker 2 (13:28):
Right, all right.
So okay, good.
How is that an antipsychotic?
Well, there are differentcholinergic receptors.
They hit the M1, that's the waythey call it, and the M4.
Okay, in the cortex.
Good, cortex is your high partof the brain.
We think psychosis comes fromdopamine dysregulation in some
of the deeper lower parts andthe cortex may sit on that and
(13:50):
quiet it down.
Just like in real life, yourconscious thoughts sometimes sit
on your unconscious thoughts incase you noticed, uh, the
cortex.
The old psychoanalysts talkedabout super ego, your sense of
conscious and your conscioussense of self, and it would
modulate it, which was youremotional self.
Well, guess what?
(14:11):
The cerebral cortex, theprefrontal cortex, modulates
deep subcortical systems likedopamine.
And so the analysts, in a funnyway, were not that wrong.
And so it's the corticalsystems that help to keep
dopamine systems in check, andwhen they're out of check with
the illness, you improve it anyway you can.
And by God, co-benthy, whichthey're bragging about being
(14:34):
muscarinic or cholinergic is theterm turns out to work by
quieting down dopamine systems,just by a different pathway.
So it's cholinergic ontodopamine, and it does it without
bonding to dopamine receptorsor causing some of the side
effects.
Now, is it as good as the greatdrugs like Clozapine?
(14:54):
We don't know yet, but there'sno question it's an
antipsychotic.
I'm going to tell you somethingelse Most antipsychotics
virtual are not pleasant.
I mean I when I say that.
I mean it's not that you can'tgive them away at a cocktail
party, but you have motor sideeffects that people feel them.
Speaker 1 (15:15):
Now they have tremendously long-term.
Speaker 2 (15:18):
Yeah, you know people don't like them and sometimes
as a psychiatrist, and you havesomebody who's lost touch with
reality.
Now he's back in reality andwants to go off his meds.
Sometimes out of reality feelsmore appealing than to reality.
To some of these folks who'vebeen ill, you know their lives
is not what it was.
Quote, quote intended to bestruggling Hell with it.
(15:39):
I'm stopping medicine At leastthey're my own head.
Happens a lot, a lot, not alittle, a lot, okay.
And the fact that thesetraditional antipsychotics, they
make you feel a little funny.
That's why we often give extradrugs to help side effects.
Well, one of the things thatstruck me most about Combenfi is
(16:00):
that, relatively speaking, it'svery well tolerated.
It's not principally adopaminergic drug.
It works on dopamine indirectly.
You with me.
It does acetylcholine thingsand guess what?
They're in the cortex, frontalcortex, and they drop down to
quiet dopamine indirectly andit's a much more pleasant
sensation in the body.
(16:20):
So one of the things I likeabout CoBed-3, that I like a lot
is that it's better tolerated.
Now, having said that, thecholinergic systems have some
bad side effects and I told youearly on when they were
developing the drug.
So the drug Cobenfi is theactive drug, zonomaline and
trospium, which isanticholinergic, to help the
(16:43):
side effects.
So in one pill they have a drugto help the side effects and
the active drug.
And in fact, when people takeCobenfi, my experience and when
you read from the controlleddata because that's all we've
had for a long time is from thedrug trials is that the patients
find it much more tolerable.
I love that.
I love that.
Now I, as an old scientist,clinical scientist, I have a
(17:08):
million questions I'd love toanswer.
Unfortunately I retired fromrunning that thing at the NIH,
but it's an interesting drug soit's very well tolerated.
A little bit of a differentmechanism.
It indirectly hits dopamine.
Okay, I like that.
Would it be helpful if youadded it to other antipsychotics
in patients who are not fullydoing?
Well?
Don't know the answer, but I'llbet it will.
(17:28):
I think you're it to anti,other anti-psychotics and
patients who are not fully doingwell, don't know the answer,
but I'll bet it will.
Right, I think you're going tosee in a lot of different
directions but a lot of peoplewho are medication resistant
might experience benefits that.
That is the traditional uh todd.
That's your traditionalindication for clozapine right
and if it were in my hand rightnow?
(17:48):
I know the company, I knowthese guys.
This is not a knock on thepharmaceutical industry, but
just a knock on thepharmaceutical industry.
They are I can't use that word.
They're nervous Nellies.
How about that?
For a benign term, okay, andthey don't like to.
If they, they have somethinggood, don't fool with it.
Um, but this drug should beused in a lot of different ways
(18:12):
until we fully understand itsbenefit yeah, but they're being
they're being driven by r&dsaying we need a new product, we
want something new.
Speaker 1 (18:18):
You know, like they have to find the difference
between those.
Those two uh influences, don'tthey?
Speaker 2 (18:23):
you got it and I was gonna.
I, I think people this but theanti-psychotic drug, the
pharmaceutical drug business, isa big business.
Among the drugs, theanti-psychotics are among their
highest revenue driven drugs.
In its peak, the drugRisperidone probably earned
about $5 billion a year billiona year.
Speaker 1 (18:51):
Well, I mean, you know, it's no secret that
pharmaceutical companies reallylike it when you get on a
medication you have to take forthe rest of your life.
Speaker 2 (18:55):
You got it and the only thing you know, the only
things the pharmaceuticalindustry does not like, as you
may know, is the fact thatthere's a patent law and once it
goes off patent, other peoplecan do generics they can do
generics, they can do generics,yeah, they can take it away I
don't know, I mean dad, I don'tknow how familiar I with drug
development, but it's afascinating thing.
It's a it's called hatch waxmanlaw that did that.
(19:16):
Hatch was orrin, hatch goodrepublican, and waxman was a
congressman he was a senatororrin and waxman was a
congressman from that jewishcongressman from mass, and they
created a law.
They both had things theywanted and so they let the
pharmaceutical industry get somemore protection on certain
(19:37):
things.
That was a hatch and Waxmaninsisted that once the drug is
off patent, all the informationon that drug can go to generic
manufacturers.
Off patent, all the informationon that drug can go to generic
manufacturers so that once it'sdone I can take everything from
the FDA and now make the drugmyself.
Speaker 1 (19:57):
Before that you have to do all that stuff yourself.
A little anti-monopolizationkind of stuff.
Speaker 2 (19:59):
Correct.
That's right, todd, and thatcreated the generic business.
Generic was not a businessbefore that.
How about that?
You know, I'm sorry, I'mrambling, you stopped me.
Speaker 1 (20:13):
No, I the I want you rambling is makes great show.
Speaker 2 (20:22):
I'm just sorry that I can't speak to the audience and
hear what they'd like to say.
I like that.
Speaker 1 (20:26):
Maybe someday we'll me give you We'll get a live
show going at some point in time.
No, go ahead what you got hereyou go, todd.
Speaker 2 (20:34):
The worldwide anti-psychotic drug market is
expected to grow from about$14.5 billion right now to $26
billion by 2032.
So this is a big market andit's now a large generic market
too.
So the pharmaceutical industryis very sensitive to not fooling
(20:55):
around with what they had, Iknow in my working in drug
development.
But this one sort of snuckthrough got out and has given a
lot of enthusiasm and positivevibe to our community.
Speaker 1 (21:07):
Like you say, but it's got.
You know you're talking.
We're talking about a new medthat's already got 25 years
worth of development on it,which is, you know, it's mind
boggling a little bit, but it is.
Speaker 2 (21:18):
When it came out, todd, I was away from that for a
bit.
I was taken back when I saw Ihadn't realized my old buddies
were developing it again and Ismiled to myself.
And by God, it's a goodantipsychotic.
They added this other drug toit so the side effects were less
and they did a nice job.
(21:39):
Steve.
Paul did a nice job on it, butyou're right and there's got to
be more Me I'm always thinking,but I like the mechanism of
indirectly softening ormodulating dopamine transmission
and I didn't think of it thatway.
The people literally weren'tsmart enough, but that's what it
does and that's what it doesand I love it.
Speaker 1 (21:57):
No, I'd love to.
I've got a theory that I would,that you, we, I've got a crew
here that is very qualified totell me that I'm 100% wrong or I
might be onto something or Ineed to give up my career in
behavioral health care and sopossibly Stacy Rayetta or
(22:19):
Shannon want to pitch in.
But I work with families prettyregularly.
I ended up giving some.
The family was faced with anindividual.
He was suffering from psychoticfeatures.
It was new to him.
He was in that kind of firstepisode category.
Families also don't knowanything about this.
(22:40):
All of a sudden they're facedwith a family member who's got
psychosis in their profile, etc,etc.
The whole thing.
They're just trying to get asmuch information.
I ended up having to call withthem.
I actually we did a record ofthe call.
I went back to the script thatit.
You know the notes that gettaken, and I made a blog out of
it.
Like, look for the you know,for the layperson, the person
(23:01):
out there who's really trying tofigure this out.
There are a couple of differentways that psychosis occurs for a
person.
Diagnosis aside, you've got aperson who suffers from thought
disorder, it's got psychoticfeatures, and they may be
experiencing psychosis as aresult of drug use.
But the chances are good it waslatent and they're going to
(23:22):
suffer from psychosis for therest of their life and they need
an antipsychotic.
You've got people who areliving in this category and
we're finding them these daysthat suffer from a psychotic
episode as a result of drug useand if you take the drugs away
they don't have psychosisanymore.
And we're seeing these folks.
They're out there but they'vegot to be really careful about
(23:46):
what they put in their body.
And then you've got people whosuffer from pretty serious mood
disorder, bipolar disorder oreven psychotic depression and
those kinds of things.
And the meds differentiate alot of times in these two kinds
of categories.
Because a person who suffersfrom mood disorder let's say
it's mania, let's say it'sdepressive or maybe they
experience both at high levelsbut if they go over a threshold
(24:07):
on the mood whether manic'sdepressive or maybe they
experience both at high levelsbut if they go over a threshold
on the mood, whether manic ordepressive, once they go past
that threshold they start tohave thought disorder and they
can even have a psychotic break.
Sometimes you can give one ofthese people, a person who's
suffering from a condition likethis a mood stabilizer without
(24:29):
an antipsychotic and so long asthey've got a pretty decent diet
, they're taking care ofthemselves and they're getting
sleep and they're on a moodregulator, they never pop over
the threshold and experiencepsychosis, whether it's high or
low, and they may be able to getaway with not having an
antipsychotic on board.
And it basically makes threecategories of people suffering
(24:52):
from psychosis and the variousways they get treated.
That's a dumbed-down way ofexplaining it to folks who are
faced with this for the firsttime, but it was approachable.
Would you add anything to that?
Am I completely off and whatwould you add?
Speaker 2 (25:08):
Todd, I would never say you're completely off you'd
be among the first dr the wordswe use in jersey.
I can't say you understand whatI'm saying.
I do, okay, I don't.
I don't know if anybody outthere can hear my jersey accent.
I haven't lived there sincesince I graduated from college.
I'd just like to call it home.
(25:29):
I'm teasing you.
I'm teasing you.
Psychosis means loss of touchwith reality, often shown by
delusions.
Delusion is a false belief,todd, and I know many of your
people out there know that.
But just for clarity, so afalse belief might say the FBI
is after me, but it's not true.
(25:50):
Or that person over there meansme harm.
Those are paranoid kind ofthings.
They're not bizarre becauseit's possible the fbi is after
me, they're just not there's.
Speaker 1 (26:03):
Because you're paranoid doesn't mean they're
not after you.
Yeah okay.
Speaker 2 (26:06):
But then there's what's called bizarre delusions.
So when I talk about alienscontrolling or reading your mind
or you putting thoughts in myhead, that can't happen and
those are mostly characteristicof patients who have
schizophrenia, okay, and bizarredelusions.
And some folks are required notjust delusions, but bizarre
(26:27):
delusions, now losing touch withreality.
Ie, psychosis occurs in a lotof different disorders,
including depression, thedepressive psychosis, just what
you were talking about usuallyhave a globality about how
depressed you are or about howit's awful for your children
that I'm staying alive, and itdoesn't mean just schizophrenia.
I was just reviewing a case I'mwriting about in my book for a
(26:48):
patient who had severepostpartum psychosis.
One of the strangest psychosis,most deadly psychosis, are
psychosis that typically occurthe postpartum blues or sadness
having given birth pretty commonafter the first two or three
weeks, but a month later, whenpeople start getting depressed
and they get globally depressed.
(27:09):
And this particular woman cutherself all over her body with a
one-month-old child at home andyou read them.
We all hear about these.
People kill infants and soforth and that's psychosis in a
postpartum state.
Which is pretty, which is bad?
No question bipolar, a bipolarpsychosis.
You want to see grandiosity.
(27:30):
So not only am I dealing notwith reality, I want you to know
okay that Julius.
Speaker 1 (27:36):
Beezer is nothing compared to me Right, I'm the
greatest rapper that ever lived.
Speaker 2 (27:40):
You got it, you got it, and that's how I say I'm a
doctor.
No, that's not, it's a joke.
It's a joke.
I don't just play one on TV,I'm a real guy.
All kidding aside, it'sinteresting, todd, that you
mentioned it.
When I was training and then,when I started becoming a
scientist, I came to the UnitedStates.
I always loved psychosis and itsounds funky because I don't
(28:02):
know why I liked sick peoplewhen I did internal medicine for
a year after medical school andthe psychosis is a
characteristic of our more illpeople.
Now, the people who haveschizophrenia have psychosis,
but they gosh darn it, todd.
They also have flatness ofaffect.
They don't express themselveswell um.
Speaker 1 (28:22):
They pick up on social cues.
Speaker 2 (28:23):
Well, they look like they've got on the spectrum and
they have and and they have, uh,executive function difficulties
.
You know it's a tough one.
So if there's any folks outthere listening to us who have
family members who haveschizophrenia, you know these
things, the so-called negativesymptoms.
You know these things, theso-called negative symptoms,
things they don't have, and theso-called positive things that
they have that shouldn't bethere voices and so forth and so
(28:45):
on.
And I've been around medicineand psychiatry a long time, but
that illness, to this day Ithink about it and how hard it
is for the families.
And I don't know if there's anyfamilies out there listening to
us today who are working withkids who have the illness.
Speaker 1 (29:03):
For certain.
Speaker 2 (29:04):
Yeah, and let me say something parenthetically on
that.
When I meet a new family and soforth, one of the things I like
to do when I get to know them,todd, is if they have a, a
sibling, I like to bring in thesibling and chat with, not to
find oh, I'm going to findsecret information.
No, no, no, no.
The siblings have a very toughtime and they, in other words,
(29:29):
they got a brother or sisterwho's very ill.
It takes a tremendous amount ofyour mom and dad's time.
There's just so much oxygen inthe room you can, at one level,
resent that you're not gettingthe attention and then you say,
holy mackerel, I can't resentthat.
My, my sister's so sick theserious illness right yeah, you
know I don't.
That's not me, of course theyshould, but they feel it and
(29:52):
when I bring guys in and gals, Ilike to tell them thank you and
I say to them thank you, that'scool I always do it because I
said you know you're doing whatyou're doing to be a good
sibling and caring about him.
But I know it's hard, and it'shard maybe hard for your parents
to step aside and takethemselves away from your ill
brother.
But let me tell you, thank you,because I know by being
(30:14):
yourself, by caring about thefamily and going on with your
life productively is a hugething, and it's made difficult
because you have a sibling, notas bad as him or her, but it's
tough.
And so I'm just pulling youaside to let you know, as a
shrink, I know what you gothrough, not specifically, but I
know it's hard and thank you,you're doing it for your brother
and your whole family.
Speaker 1 (30:35):
Well, and it's not just hard for that moment, it's
hard for a lifetime, you know,for for so many, which is why
you know we're pretty helpful.
We're super grateful for thework that you know helping the
home and you're doing with thesefolks to help them find kind of
long-term care solutions.
I'm curious yeah about.
I'm curious about um, if you're, you know, just to circle it
(30:57):
back around, are you seeing theresults of CoBENFI in the
populations that you serve rightnow?
Speaker 2 (31:06):
It's just getting Todd, it's just getting out.
So when we can reconvene thissession a few months from now,
I'll have a better feel for it.
Speaker 1 (31:14):
Yeah, let's see.
You know, we should pick it upnext year and figure out what
you're seeing there it'sinteresting.
Speaker 2 (31:20):
Okay now.
So the drug was from lily.
Sorry, sorry to talk like thisis the market week.
Okay, so the drug was from lily.
They let it sit there.
The former most senior medicalperson at lily formed a small
company that licensed it out.
That was my, my buddy.
Speaker 1 (31:36):
Oh wow, and fixed it up.
Speaker 2 (31:40):
Steve Paul, and Steve is very sharp and he likes to
invent new blah, blah, blah,blah blah.
So they licensed it.
Then what they did?
They made sure they had theaddition of this other drug to
fight the side effects and thenthey just sold it to Bristol
Myers about a month ago, twomonths ago.
Bristol Myers is one of thelarge pharmaceuticals, or we
(32:00):
used to call it Big Pharma, andsometimes when I say Big Pharma,
people are listening and theysay did you say Pig Pharma?
No, no, big Pharma.
Speaker 1 (32:10):
Though they've been interchanged, I'm sure.
Speaker 2 (32:13):
I've had many people say what does Pig Pharma have to
do with it?
I say no, it's Big Pharma.
Speaker 1 (32:23):
Now it's controlled by Bristol Myers, which hasn't
had a good psychiatric drug in abit and they'll do a nice job
marketing it Now it's-.
I bet Eli Lilly is very happyabout the fact that Bristol
Myers got it.
Speaker 2 (32:28):
I haven't had the opportunity to look at the
contract, but you know they'reparticipating in some of the
benefits.
Yeah, sure, the way it's donedone, but it's an interesting,
complex business, so we'll seewhere come benfi does.
I I'm after those guys a littlebit to do these other things
about it that I'd like to seedone, but that's another.
That's another uh question.
(32:48):
I'm going to call steve one ofthese days and have a chat with
him on that.
Speaker 1 (32:52):
So one thing I'll ask about cobenfi that I I think it
is is I'm curious about to seeif it's an effect.
I don't know if you have athoughts about this but, um,
when you see people who aresuffered from long-term
psychosis, uh, and you know,maybe they've, they've done,
they've done the med gauntlet,they've been on everything under
(33:13):
the sun and you know they maynot have what we would call a
full psychotic break, but theyhave persistent delusions.
My parents I've got a clientright now.
This individual, he attackedhis parents which is for people
who know about psychosis andschizophrenia attacking a family
(33:36):
member is pretty common,unfortunately but attack his
parents because they were aliens, right, and despite the fact
that he's been in care for quitea while now and actually doing
pretty well, still maintainsthis persistent delusion.
His parents are aliens and theystill can't have a conversation
with one another.
And they still can't have aconversation with one another.
(34:00):
Will you think that this drugor this complement of drugs in
one pill will have any betterimpact on these persistent
delusional features thataccompany individuals suffering
from psychosis, especially ifthey have schizophrenia?
Do you think it's going to havea little better reach into some
of the symptomology?
Speaker 2 (34:22):
Todd, that's a great question at many levels.
I can circle around and do that.
Speaker 1 (34:27):
You know, I like to ask a good question, you know.
Speaker 2 (34:30):
Yeah, I was.
No, no, it's an interesting one, one that I've had more than a
little experience with, becausesometimes, when they don't
believe their parents are angry,they also go feel that way
about their doctor, which is meright.
He was obvi, and we'll comeback to the violence associated
with this illness and thedangers of it, and it's real.
Next, do I think co-benthywould help with those people?
(34:50):
Now you're asking me as ascientist.
See, I would love to see aclinical trial and I'd like to
see it alone, with these folksand in combination with another
anti-psychotic, to address thatquestion.
Now let me tell you somethingindustry doesn't love those kind
of studies, do you know why?
Because if something goes wrongor it's negative, they don't
(35:11):
want to hear it.
Okay, I?
want to know the money yeah, Iwant to know the answer.
So if it's negative, okay, welook at it this way.
Negatives are important, alwaysare.
So it's slow to get going to doit Now.
With the current situation thatwe all know in terms of the
attitude towards government andgovernment funding, with the
(35:31):
current administration, how muchmoney there's going to be to do
trials like that, supported bythe government.
I truly don't know.
I have no idea.
In the past you would see some,but it's a great question.
You know, todd, you would haveloved being with us for 20 odd
years.
I was at the NIH for 23 yearsand we were in what was called
the Intramural Research Program.
(35:53):
So the National Institutes ofHealth and National Institute of
Mental Health, which is one ofthose institutes, has what's
called an intramural and anextramural program.
Extramural are all theuniversities where I give grants
to them or trials I'm settingup and I want people to
participate in, and that's thelargest amount of money these
(36:13):
days that's spent.
The original part of theprogram was the intramural
program, which is what I waspart of and what has made the
NIH famous, and the intramuralprogram is where you have
scientists on board right hereI'm pointing to the clinical
center about three miles fromwhere I'm pointing and the
clinical center on the NIHcampus, and that's where we
would run these things and youwould have funded research, not
(36:36):
grants.
You'd have a certain fundingfor a year and they would review
your work every few years veryaggressively.
But I didn't have to have thingsapproved.
They trusted me as a scientistand there were scientific
reviews, all sorts of thingslike that, but it gave you the
freedom to do your own.
The most famous discoveriesfrom the NIH broadly come from
the intramural program and I'llgive you one, just not to derail
(37:01):
too much.
But I've been thinking aboutthe intramural program because
it was my home for quite a fewyears.
And, of course of now, what'shappening in government.
And I give the example of theNational Cancer Institute, which
is one of the institutes.
It's part of the NIH butactually has a direct funding
right from Congress.
It's huge Now, when I was thereall those years, one of the
(37:24):
things I respected and likedabout the NCI National Cancer
Institute they always hadpatients real life even though
they did a lot of lab work and Iwas fascinated my years because
the drugs they were using werenot dissimilar to what I used in
medical school in my internshipand nothing new had come.
And then about, I don't know,15, 12 years ago 15 years ago,
(37:47):
time fast Steve Rosenberg, whomI knew, developed the first drug
for melanoma and that was amonoclonal antibody type
approach, and it was enormouslysuccessful.
Melanoma was not a deathsentence, but it was wholly
different.
Speaker 1 (38:04):
It was bad yeah.
Speaker 2 (38:05):
Bad and that one finding has rocketed anti-cancer
treatments using some of thosesame mechanisms enormously.
Now I mention it for thefollowing reason I'm going to
bring it home to us who careabout mentally ill people.
At the present time there areno patients with schizophrenia.
In the NIH Clinical Center Iran a ward that had 10, 12
(38:28):
patients who were there formonths at a time, drug-free.
We managed them and StElizabeth's had a research arm
that would run from NIH.
There are none of them.
No patients, none, zero.
And that's another conversationand it's about genomics and
it's about science and it'sabout trouble for us In
psychiatry.
(38:48):
We care for men.
Do we need more trouble?
Now this came along so I haveno idea what's going on.
Now I'm not going to say nowise-ass cracks, but it's
interesting.
It's a fascinating time to livethrough.
But the clinical center and theintramural research program was
the hallmark of mostParkinson's disease and the use
(39:10):
of dopaminergic agonists camefrom that came from there.
It goes on and on and on.
Speaker 1 (39:15):
One of the biggest treatment modalities we've got
for Parkinson's right.
Speaker 2 (39:18):
Yeah, right, so I'm just saying that it was a unique
setting.
Universities wanted their money.
Everybody there wanted theirmoney.
Musk and Trump doesn't likethem giving out money, but the
universities, they have theirown congressmen, and so it
started in mental health.
It was genomics are going totell us everything we need to
know.
We don't need patients and it'sbeen one of the saddest
(39:41):
developments, but that's aconversation for another time.
Speaker 1 (39:44):
Todd, yeah, studying humans through chemistry labs
yeah, it's an interesting kindof proposal.
Speaker 2 (39:50):
Yeah, Genomics is a tool to help study people To
them.
People are a tool to help studypeople to them.
People are a tool to help studygenomics.
Capisce.
Speaker 1 (40:03):
Yeah.
Speaker 2 (40:04):
And that's what the story.
If I had to say it in onesentence, that's it.
Speaker 1 (40:07):
I'm not saying I'm not excited about the study of
genomics, like I think it'sfascinating stuff and I think
it's got real potential, butyou're going to need human
beings.
Speaker 2 (40:17):
And that's the purpose of it.
And that's the purpose of it.
And that's the purpose of it isto help people right, and they
lost that track.
I'm telling you, they want tohelp people in a theoretical way
, and then yeah, they lost theirarms length way yeah, they lost
their, but it came at theexpense of patients and that's
the.
That's the thing.
When that first came and I gota kick out of it, I felt like I
was in in putting a dunce cap on.
(40:39):
In China they make allacademics put you're dumb.
If you were an academic, well,if you were interested directly
in patient science, they'd put afigurative dunce cap on you.
You're not smart, you should bein genomics in the lab, and it
was a very strange change thatoccurred during my last some
years at the NIH.
(41:00):
I've been out for quite a while.
I still get calls fromreporters because those meetings
were all documented.
And when one of these drugsthat we were talking about then
is now having trouble in thereal world because it got
approved.
And then they look at thereporting.
You always see Dave Picardsaying something funny.
So I get calls.
I'm not sure the senior FDApeople love me as much as I
(41:23):
deserved, but anyway, that'sanother story.
We can put that on anothertopic.
It's part of the drugdevelopment situation.
Speaker 1 (41:31):
Well, it seems like we've got several topics,
including Cabin Fee, to followup on a little later on to see
where it's going to see what newdevelopments happen and what's
happened on the national levelwith funding for mental health
care and those kinds of things.
I'll be excited.
Dr Picard, you're alwayswelcome to the show.
It's just a blast to have youon.
Stacey Rayetta Shannon, I knowyou know Dr Picard.
(41:55):
He has a lot to say, so Iappreciate you joining us.
Just the same.
We'll talk a little bit moreabout how it lands on the road
out there with helping the home,but this has been Head Inside
Mental Health on WPBM 1037, thevoice of Asheville, Todd
Weatherly, your host, dr Picard.
Stacey Rayada Shannon, thankyou for being on the show again.
Speaker 2 (42:16):
Thank you, man.
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