February 18, 2022 • 37 mins
Dr. Steve Groff, Founder and Chairman of Groff North America speaks about how he became one of the first companies to sell cannabis to the Federal government, and how it will benefit veterans and others as he works to promote the study and rescheduling of the plant.
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Steve Groff (00:03):
Interestingly, psilocybin and THC are both
very, very powerful moleculesthat have no lethal dose in
humans. We've known this foryears. He can't kill you. We've
known that there are credibleanecdotal stories of and some
early research again for bothTHC and psilocybin can help
reboot certain brain pathways. Ithink both these plants and both
(00:25):
these molecules have tremendouspotential to help with PTSD,
depression, anxiety, smokingcessation, opioid addiction.
Charlie Malone (00:38):
Welcome to Season Two of the policy vets
podcast, engaging with leaders,scholars and strong voices to
fill a void in support of PolicyDevelopment for America's
veterans. With your host formerSecretary of Veterans Affairs,
Dr. David Shulkin. And theExecutive Director of Policy
beds, Louis Celli, today's guestDr. Steve Groff founder and
(00:58):
chairman at golf North America.
Louis Celli (01:05):
Mr. Secretary, one of the advantages of doing a
podcast as often as we do themis that we really get to stay on
top of kind of breakingdevelopments fairly quickly in
the community.
Dr. David Shulkin (01:16):
Yeah, I think that's true. When it comes to
this issue that we're talkingabout today, medical cannabis,
it's hard to understand exactlywhat's going on. Clearly, I
think the states have movedvery, very quickly, the federal
government seems like is justbeing slowly pulled along. But
still a big gap in the way thatpeople can access medical
(01:41):
cannabis with state policyversus federal policy. And
frankly, it just doesn't make alot of sense. If you're trying
to get help for condition andyou want to be treated with
medical cannabis that you haveto worry about where you live,
not necessarily what the rightthing to do is.
Louis Celli (01:58):
And that being said, patients are pretty much
left to you know, selfdiagnosis, self treatment, you
know, the, the the informationthey find on the internet, or,
you know, whoever's behind thecounter at the whatever
dispensary, or or cafe theyvisit, so it's really hard to
tell, you know, that. Socannabis has been, has been
(02:21):
touted as being a promisingmedication for relief for
Crohn's disease and forepilepsy, seizures, for pain,
pain management, a whole bunchof different things. And it's
really hard for patients toknow, what strain should they
take? What's the dosage? Howoften should they take it? In
what manner should they take it?
Should they smoke it or eat itor a suppository or a tincture?
(02:41):
You know, how do they take it?
So it's, you know, I just thinkthat the federal government has
really left these patients outthere by themselves. And it's,
it's hard for them?
Dr. David Shulkin (02:55):
Well, it's one of these things that, you
know, the federal governmentcan't believe that simply
because they have it as ascheduled one that people aren't
out there using it. And so, soreally, I think, is a
dereliction of responsibility tonot allow this chemical
substance to be studied in aresearch way to be able to
(03:17):
answer those questions to, toallow veterans to be able to
speak to their doctors freelyabout this when they're cared
for in the VA. So there are awhole bunch of things that
frankly, just need to changewith this. I think that today
we're going to talk to Dr.
Groff, who is part of thatchange by being part of a new
initiative where there arefederally designated growth
(03:40):
facilities so that compoundswith good quality can be sold to
federal researchers who canstart moving forward with
answering some of thosequestions.
Louis Celli (03:57):
You know, it really makes it very difficult on the
largest health care provider inthe nation, the Department of
Veterans Affairs who has so manydifferent physicians that work
there who have a variety ofdifferent backgrounds and
experiences, and many of themare very interested in this
topic, but they are, there's agag order on them, you know,
(04:19):
because the federal governmentfinds that it's, you know, that
it's, it's illegal to use. ManyVA physicians struggle with
this. And I don't mean to betelling you, no one knows better
than you. You were really at theheart of this at a time of
transition. As a matter of fact,you were one of the first
secretaries or the firstsecretary, if I can think back
(04:40):
correctly. That issued a memo,really telling doctors Hey,
listen, you can't hold thisagainst a patient who is
behaving legally within theirstate when they come to you and
ask you for medical advice orfor you know, additional medical
treatment you can't holdCannabis use against them?
Dr. David Shulkin (05:01):
Well, it listen, even the Secretary is
very difficult to get a straightanswer from the Department of
Justice about what we wereallowed to do and what we
weren't. And so, you're right, Iwas pushing the envelope because
I just did not feel thatveterans were getting the right
care. And frankly, our doctorswere very confused. Remember,
doctors in the VA, more thanhalf the majority of our doctors
(05:24):
practice at the VA, but alsopractice another location,
typically, an academic medicalcenter, where on the days of the
week that they're outside theVA, they're allowed to talk to
their patients and prescribemedical marijuana and, and
participate in the wholecontinuum of services, where
(05:45):
then the days that they're atthe VA, all of a sudden, they
have as you described this gagorder, and that just isn't the
right thing to do for patients.
It's not the right thing to dofor the people who work in the
VA, they want to help theirveterans as much as anyone and
and knowing that they haveinformation that they can't
provide to their patients, theirveteran patients is really not a
(06:07):
good way to practice.
Louis Celli (06:10):
Now, one of the things I think we're going to
hear from Dr. Golf today is howthis is really a watershed
moment in this movement in thisindustry with cannabis and the
federal government relaxing alittle bit and starting to
invite more growers in toproduce a higher quality plant.
This, let's think ahead,couldn't this open a real
(06:31):
opportunity for the Departmentof Veterans Affairs when it
comes to scientific research?
Dr. David Shulkin (06:36):
Well, now I don't see any reason why the VA
wouldn't lean heavily into thisfrom a research perspective,
that's the reason the VA isthere to be able to step in
where the private sector has notfully addressed the needs from
either research or clinicalperspective for veterans. And
(06:57):
the big hold up in the VA forthe researchers was that they
couldn't legally obtain thecannabis in order to do the
research. Now. Now, I think thatthis is becoming much easier.
Louis Celli (07:10):
You know, one of the things that that I've
advocated for in the past is totake a look at the
infrastructure, say, of the DCVA Medical Center, right? And
why hasn't VA looked intoopening their own medical
school, because there's such ashortage of medical specialties
and physicians and they couldhome grow them. And then there'd
be a, you know, a requiredperiod of service that they
(07:32):
would serve, they could do thisas well with a research
facility, right, they couldturn, you know, one of their one
of their properties, the Air Actis looking at how many how many
unused properties they may have,they could turn one into a high
grade high end, really worldclass, medical facility that
studies cannabis, and they wouldbe world renowned for it.
Dr. David Shulkin (07:54):
First of all, I think on the medical education
side, you have to remember thatVA trains, literally the
majority of medical students andresidents in the country through
their academic affiliations. AndI think that's been a program
that has worked well. So havinghaving the federal government go
into establishing their ownmedical school. Not sure I would
(08:17):
go that direction, workingcloser with the Department of
Defense that actually, as youknow, does have its own medical
school, I think makes a lot ofsense. But on the research
facilities, I agree, I thinkthat that this is an opportunity
to have a center of excellencereally not just restricted to
(08:37):
cannabis, but all newdiscoveries related to helping
veterans. And look, we're seeinga time right now where the
President's announcing thereestablishment of the Cancer
Moonshot calling for funding ofa new agency called the Advanced
projects research health agencyor ARPA H. And, you know, doing
(09:00):
this in within the Department ofVeteran Affairs, I think makes a
great deal of sense as well,
Louis Celli (09:04):
really great point.
They just funded ARPA H withwhat $6 billion to get them
started. So they're, they'reserious about this.
Dr. David Shulkin (09:12):
Yeah, I think it's a request for funding. I
don't think that the funding hasbeen approved through Congress
yet, but certainly, there's abig push for
Louis Celli (09:19):
that. So and, you know, part of that, in addition
to cancer could certainly beaddressing the opioid epidemic
and suicide prevention. Youknow, and I think that this is
all related. Sure. So let's,let's get Dr. Groff in here and
find out where this movement isgoing. Okay. Dr. Groff, welcome
(09:45):
to the policy. That's podcast.
Hey, thanks for taking time outto join us today.
Steve Groff (09:49):
Great to be here.
It's an honor.
Dr. David Shulkin (09:51):
Dr. Graf.
This is a really interesting butalso complicated topic. Whenever
you talk about cannabis for someThey're issues that get
political, whether it's vaccinesand cannabis is no exception
with all the different thoughtson this one. So I think it's
good if you wouldn't mindstarting out by telling us a
little bit about yourbackground. And what made you
(10:13):
get involved and interested inthe cannabis industry in the
first place.
Steve Groff (10:19):
Great. Again, thankful to be here. I'm a
country boy, I grew up inPennsylvania as a Mennonite farm
boy and ultimately came, becamean orthopedic spinal surgeon and
spend most of my career as aclinician but also built a large
health system here in the midatlantic called OSS health.
Throughout my normal clinicalcareer, I saw some of the highs
(10:41):
and lows of the existinghealthcare and pharma regime and
I saw some of the negatives inlater my life, I decided to look
at some of the what I think arebetter options out there and
plant based medicines, includingcannabis, and so really excited
to be in this space and workingon a unique level.
Dr. David Shulkin (11:02):
So if I have that, right, you're, you're an
orthopedic surgeon, trained todo surgery, and yet, you've
focused on medicinal aspects ofcannabis.
Steve Groff (11:14):
I did, I had a great career, again, building an
entire health system, privatelyowned hospital and clinical
practice, we were the lastposition on hospital in the
country to open over 10 yearsago. Along the way, I, you know,
a transfermate relational eventthat happened to me, I was
struck by a bicycle, I wasstruck by a motorist on my
(11:37):
bicycle 10 years ago, is ridinga bicycle and hit a 45 miles an
hour. So I was 46, I wasincredibly healthy, I had no
medical issues, took nomedicines, and instantly I was
in the trauma unit of my ownhospital with a fractured neck
and some other fractures. AndI'm blessed to be alive and
walking now and normal. But Iwent through some really
difficult times on the otherside, as a patient coming out of
(12:01):
that. And so that was anotherfactor in my life that that
pushes,
Dr. David Shulkin (12:06):
how does that accident and the difficult times
which I assume included prettysevere pain? How does that
connect you then to the cannabisindustry?
Steve Groff (12:16):
Well, I again, I went personally through some
very difficult times coming outof that, and I didn't take a
medicine my entire life untilthat tremendous accident. And I
went through some personalchallenges. I really saw it from
the other side. And obviouslyone of the biggest issues that
facing America, and that's isthe horrible opioid crisis. And
(12:37):
I became a practicing physicianin the mid 90s. About the time
that not only Purdue pharmabrought out Oxycontin, but our
our Medicare program decided totell physicians to treat pain
more aggressively. And so thosetwo things together in my mind
really kicked off what we seenow is a devastating opioid
crisis. And so I fully believethere are far better options out
(13:01):
there. And I believe that we'llback in we'll see the cannabis
is one of those options thatonce we study this better and
know more about the thepharmacokinetics and things like
that, that we're going to beable to treat patients including
best with far better options.
Louis Celli (13:17):
I'm really excited to have you on with us today.
And I'm sure you're aware thatthis isn't our first podcast,
you know that we've done on thetopic of medical cannabis as a
matter of fact, you know, that'show we met you. We had nurse
Teresa Jackson on from AMVETSlast year who who introduced us
to you.
Steve Groff (13:33):
I was fortunate to meet her recently. She's an
incredible woman very inspiringand love from work and love to
support it.
Dr. David Shulkin (13:41):
Now, let's get right into the issues
related to medical cannabis. Andand I think that there's a lot
of people who have studied theimpacts of cannabis and the
cannabinoid system in general.
Your company has been selectedto be one of the first four
commercial growers in the nationas a federally licensed cannabis
(14:03):
Growth Facility. And so I thinkpeople are used to seeing
cannabis now in a number ofdifferent states and sort of
facilities that are growing in anumber of different states. But
this is a new development forthe federal government to have
these facilities. Can you tellus a little bit more about that
and what that means to thelistener who is trying to
(14:26):
understand what it is thatyou're doing, and we're excited
Steve Groff (14:31):
to be in this position. For 50 years, the only
federally legal cannabiscultivation took place at
University of Mississippi asmost of us are aware. Over the
last 25 years the statesindividually have been very
aggressive starting withCalifornia, and most recently,
Mississippi and their 38 medicalmarijuana programs at the state
level. None of those arefederally legal. The oversight
(14:53):
and regulations are extremelyvaried and vary from state to
state. So we see This is a hugesea change of approach from the
federal government to not onlyallow new cultivation but allow
the study of new genetics, andtruly open up the pathway to
unleash the American science andacademic world to truly study
(15:16):
this in a much better way thanit's existed for the last
several decades. So we'rehonored to be in this position,
we worked very hard over thelast two years with the FDA and
the DEA to receive thisunprecedented suite of
scheduling licenses. And nowwe're going to have research
material and manufacturing on anew level that's never existed
before that will be available tothe research community, the
(15:38):
manufacturing community andreally the rest of the world.
So,
Louis Celli (15:41):
you know, this federal, this federal
identification really shows thedifference between what science
can look like when it hasfederal oversight as opposed to
what the states currently aredoing and overseeing. You know,
before we even spoke, I went toyour website and one of the
things that that most struck methat I was most impressed with
(16:04):
was the layout of your websitelooks really more like a
commercial agriculture webwebsite, as opposed to, you
know, a cannabis or even patientcentered or focused website, it
looks more like a scientificbusiness to business type of
website.
Steve Groff (16:21):
So I come from obviously a long career in
healthcare and working withscientists and working at the
highest level on science. And sowhen I decided to enter the hemp
and cannabis space, I wanted toreally play at that same level,
we we saw the need for focus onscience and data. In cannabis.
We know the wave is coming. Wecan't deny that cannabis is a
(16:41):
massive movement across thiscountry around the world.
America has been behindcountries like Israel and Canada
and others where research ismoving much more quickly. And so
we also believe now that thisnew paradigm exists, we call it
cannabis 2.0. In America, webelieve that unleashing the
(17:01):
incredible power of the Americanscientific community will be
incredible and will help uscatch up and really lead the
world in research in this typeof plant medicine.
Dr. David Shulkin (17:11):
So Dr. Goff what when? Are you going to have
the first product available?
When When can people access it?
And does this mean now that youhave a facility like this, that
the Department of VeteranAffairs is going to be able to
get their cannabis from yourfacility or one of the other
(17:34):
three facilities to be able toconduct research and to be able
to start working with veteranson this?
Steve Groff (17:41):
Absolutely. So we hit an historic milestone last
week where we had cultivated acrop of marijuana in our
facility over the last threemonths, first time in history
outside Mississippi, and wecompleted a transaction with the
federal government in wherewhereby we sold the first crop
to the DEA and then bought itback for research and then
(18:04):
manufacturing. So this uniqueparadigm requires the federal
government to have control ofthe flower for a period of time.
And it's consistent with the UNsingle convention, something
that was not occurring over thelast 40 or 50 years with
Mississippi. So it is truly anew paradigm. The DEA leadership
were on site last week at ourfacility and it was truly
(18:25):
historic transaction. And so wehave premium cannabis material
now available, we'll continue tocultivate this was just our
first crop. We were extremelypleased with our our chemistry
of the plant with really strongTHC levels, which we think are
important for research. And butnow that this products
(18:46):
available, we completed thistransaction, we've closed the
loop on this new paradigm, wewill now continue to cultivate
and provide material forresearch and clinical study for
the VT. Not only VA but manyAmerican universities and
universities across the world.
We have grant submissions withsome of the most prestigious
universities in America now tostudy the pharmacokinetics of
(19:08):
THC for inhalation and oralingestion as well. So, again, we
see this new paradigm opening upand we're glad to be leading the
way.
Dr. David Shulkin (19:18):
So it sounds like that the applications are
really all going to be research.
There's not a plan for yourfacility to be able to provide
cannabis for veterans that wantto use it for clinical
indications.
Steve Groff (19:36):
Well, this is where we want to get the message out
and I think it's important onthis this podcast to hopefully
share and part of the challengefor us is still that the the
federal government considers aschedule one. We think that a
schedule two status is moreappropriate for cannabis flour,
no different than the opiumpoppy or the cocoa leaf. So we
(19:57):
think a next natural step wouldbe scheduled To which would open
up research tremendously, andthen allow for us to manufacture
specific formulations for groupslike veterans and hospitals and
drug companies. So we aresupporting a rescheduling to
schedule to and we think that,frankly, the paradigm that's
(20:19):
been set up for us is really thebeginning of rescheduling the
schedule to which makes sensethat the plant clearly has
medical use. It has no lethaldose, we know these things, but
we certainly need easier accessto research and manufacturing.
Louis Celli (20:34):
Yeah, I'd like to go back a second to the
secretary earlier, asked youreally what your personal story
was that you shared with us onon how you get into this? And,
you know, obviously, I thinkmany of our listeners really see
this as a cash cow, right? It'sa it's a huge money making
industry that that is, you know,it's going to be this way for a
(20:55):
very long time. But I guess myquestion is, and we talked a
little bit about this earlier inthe pre interview, why you
right? Why did the, with all ofthe federal growth facilities
out there, there are hundreds ofthem at the state level, many of
them do a spectacular job withoversight and inspections at the
state level. But why? How didyou get picked? There's only
(21:17):
four licenses that have beengranted nationwide, and you had
not grown in the past?
Steve Groff (21:23):
That's a great question. So I have been a
physician for 30 years, I'vebeen a DEA a Registrar for 30
years. Cannabis at the federallevel is part of the Controlled
Substances Act, a decades oldparadigm that exists. And that
needed to be followed to receivea controlled substance
manufacturing license at thefederal level. And so I was
(21:44):
extremely careful in the past toavoid any issues with violating
controlled substance act. And,frankly, investing or running a
state marijuana program is inviolation of the controlled
substance act. So I'm a scheduleone researcher, and approved by
the FDA and the DEA to toschedule to study cannabis,
(22:06):
looking at the antimicrobialaspects. And so when I received
that initial schedule onresearch approval, I knew that
that gave me a significantadvantage in the final round.
And we presented a very thoroughcomplete package with a
supporting team of scientistsand cultivators. And so we were
we were very pleased that wewere selected.
Louis Celli (22:26):
So just to be clear, the bottom line is that
the other applicants that youknow, that we've heard so much
about, were disqualified fromapplying for this, because they
manufactured cannabis prior tobeing given permission by the
federal government, so theyweren't even eligible to apply.
Steve Groff (22:45):
I think that's true for some of the applicants,
certainly not all of them. Butto be clear, that was a in the
final rule that came out fromthe federal government, it very
clearly stated that if you hadviolated the control subset
before you weren't going to beeligible. So I think that
certainly applied to some of theother applicants. I think there
were other reasons that I'm notaware of. But I'm just very
(23:07):
pleased that we were selected.
And it took two years of hardwork and communication. And
we're ready to move ahead andmove this whole industry forward
with tighter regulation andunderstanding of dosing and
effects that are that arescience based, and and proven in
clinical studies.
Dr. David Shulkin (23:25):
I just want to return a little bit to the
impact of this on veterans. Andif you're a veteran who's
listening and trying tounderstand what the situation is
where they may live in a statethat has legalized medical
cannabis, they may get theircare in a VA in that state where
the VA clinicians still are notallowed to offer medical
(23:50):
cannabis. They're not allowed toparticipate in the authorization
or prescription writing forcannabis. And to a veteran. This
really who's just trying to gethelp for their condition. This
is still a system that makes nosense where the federal
government in the state reallyaren't coordinated on this. Do
you see? Do you see the federalgovernment's initiative to
(24:16):
establish these growingfacilities as an indication that
they are going to try to catchup with where the states are?
Steve Groff (24:25):
I do and again, I think they want to see it under
a system of controls with withscience and data that support
safety and dosing and consistentregulations. And so there's the
federal government has a lot ofwork to do to catch up but is as
far as the veteran issue we werejust discussing. I'm a licensed
physician here in Pennsylvania.
I remain licensed and I'm veryactive in certifying
(24:46):
Pennsylvanians for the statemedical marijuana program, not
violating federal law. I simplycertify they have a condition.
I've done this for three yearswith several 1000 people and so
as it clinician I've been justastonished at the improvement in
people's lives, reducing theneed for prescription
pharmaceuticals. It's been aninspiring journey for me. And so
(25:09):
I think that we need need toclearly address this and find a
way where veterans can either becounseled as to counsel by their
own doctors to the VA, or atleast have access to a physician
or physician group like mine,where they could be certified in
a state program and have accessto this medicine that can help
change their life, save theirlife, get them away from
(25:32):
opioids, I fully support thatand that's part of our mission.
And again, doing it in a waythat's supported by science data
and legal structure.
Louis Celli (25:44):
But that really brings us to an excellent an
excellent point and part of thisconversation. Earlier you had
sent ahead a graphic that I'mhappy to, to share on our
website so that our listenerscan can look at it. And
essentially, you called it thethe cannabis spice rack. Can you
(26:05):
tell us a little bit about youknow, some of the chemical
makeup of the cannabis plant andwhy research is so important
here and you know, maybe in away that non scientists like me
can appreciate
Steve Groff (26:15):
the cannabis plant is amazing and it has hundreds
of molecules within it. And so Icame up with an idea called the
spice rack and it really helpsit's a graphic that can help
folks who are not science basedor plant based understand a
little bit you know, we look atTHC and CBD is the the two
molecules that people are mostaware of they're in the media.
And I think of those as salt andpepper if you will, and in the
(26:38):
spice rack while the other rareminor cannabinoids that are
present in lower concentrations,but could be very important.
Those are sort of the other rarespices that you would have in a
spice rack. So THC is themolecule that's psychoactive
that can cause too much we'llcertainly get you higher stone
but in the correct level and inan appropriate level THC can be
(27:01):
credibly incredibly helpful,along with CBD and hundreds of
other minor cannabinoids withinthe plant. So I think it's
important for folks tounderstand it's not just THC.
From a medical standpoint, thereare a number of molecules with
the cap within the cannabisplant that we think that can be
incredibly helpful.
Dr. David Shulkin (27:20):
You know, I can't help but thinking about
your your journey with thisindustry and watching the
federal government change. Andyou're being part of that. We're
hearing a lot about psychedelicsnow with veterans, particularly
in the treatment of PTSD. And itseems like it's a very similar
(27:41):
issue with the government beingvery restrictive on the use of
psychedelics for research andfor clinical implications. Do
you think that this is a modelthat that you're working on now
with cannabis that thegovernment is going to repeat in
the psychedelic industry?
Steve Groff (28:02):
My personal feeling is, is yes. And obviously we're
talking about another scheduleone molecule psilocybin that
comes from a number of naturalmushrooms. And so interestingly,
psilocybin and THC are bothvery, very powerful molecules
that have no lethal dose inhumans. We've known this for
years, you can't kill you. We'veknown that there are incredible
(28:23):
anecdotal stories of and someearly research again for both
THC and psilocybin that can helpreboot certain brain pathways. I
think both these plants and boththese molecules have tremendous
potential to help with PTSD,depression, anxiety, smoking
cessation, opioid addiction. Andso to be clear, we're pursuing a
(28:46):
similar path with the federalgovernment for the natural
production of these mushrooms tostudy them further in a similar
paradigm that we're doing incannabis. And so it's a great
question. And I'm equallybullish on both these platforms
in helping change the paradigmof pharma in America. And I
(29:07):
think that there's tremendouspotential and we're very active
in it. As well,
Louis Celli (29:14):
one of the things that that has frustrated me for
a long time and I've mentionedthis on the podcast before is
really the current legal limbostate that Canvas falls into at
the moment, you know, theuniversal lack of medical
specification in theprescription of the plant to a
patient patients have noscientific direction whatsoever
(29:36):
on things like dosage or ormethod of application or what
type of strand or whether theyneed all the chemicals contained
in the plant or just one or twothat could be separated out to
address a specific ailment. Howmight this change the basis of
the federal government'sideology on how to study this? I
(29:57):
mean, is this going to improvemedicine Do you See this, as a
federal government starting tomove toward a more liberal
attitude toward cannabis.
Steve Groff (30:07):
I think it's the beginning of a scientific
approach. The federal governmentdoes not want to legalize
cannabis at the federal leveluntil we know more about it. And
as you've mentioned, I'vewatched these 1000s of people in
my own clinical practice inPennsylvania, improve their
lives do incredibly well. Butthe biggest challenge for them
is to go to a dispensary, andthey have no idea what dose to
(30:30):
take, they have no idea whatproduct to take. And they'll
pick a product and then go backin two weeks, and that won't be
there anymore, it'll be gone.
And so we've made wonderfulstrides in cannabis availability
and some early research. Buttruly over the next five or 10
years, I believe companies likeourselves and others that are
committed the science and datawill help come up with the exact
(30:51):
dosing with pharmacokineticsthat all this work needs to be
done, and it's going to beaccelerated very quickly. Again,
we're working with a number ofuniversities right now on Grant
submissions. There's a lot ofextra funding coming from NIH
and Nida. Now to study this, thegovernment's aware of the wave
that 38 states have thisavailable already, they need to
(31:12):
catch up quickly. And so I thinkwill be an important part of
bringing this new science anddata and dosing, which is an
important topic.
Dr. David Shulkin (31:25):
It does sound Dr. Broth like this is really
threshold time where we're we'regonna see some real advances in
our knowledge and applicationsof cannabis that haven't
happened for decades. And you'rean important part of that and
being able to make thisavailable and be a resource for
(31:47):
those who want to learn moreabout this. So we very much
appreciate your time andspending time educating our
listeners here on the policybets podcast,
Steve Groff (32:00):
it's been an honor, I look forward to working with
you and
Louis Celli (32:03):
so before we go, I just I want to give our
listeners really a mentalpicture of what a regulated
federal Growth Facility mightlook like, can you share a
little bit you know, the theoversight, the inspections, the
waiting a little you know,things like that, so that they
know that it This isn't someoneyou know, this isn't something
(32:23):
that's being, you know,haphazardly grown in a field,
right? There's, there's a very,very scientific method to to
producing an exact plant.
Steve Groff (32:34):
Absolutely. We take this very seriously. We have a
world class team. We have an80,000 square foot facility like
any other cannabis facility inAmerica, we have high level
security that's required by theDEA especially to be scheduled
one. So we have security tobegin with. Then we have a grow
room that's more like anoperating room, if you will, we
(32:56):
have tightly controlledenvironmental factors lighting.
We have a top notch cultivationteam, we have testing equipment
to study the plant to understandexact potency. So we have things
like HPLC and GC Mass Spec, wein other words, high level
analytical equipment. We've gotextraction equipment, we use co2
(33:18):
extraction. So we have a team ofagain, great scientists and
cultivators and executives andworking together to really
provide world class cannabis forfor research and manufacturing.
Louis Celli (33:34):
So this isn't the same cannabis one would have
found, say at Woodstock.
Steve Groff (33:39):
No, I don't think so. Obviously, it's evolved in
over the last 20 or 30 years,again, led by California, I
mean, the genetics have beenhave been tweaked if you will, I
mean, five or 10% thc. From someof the early Mississippi
marijuana from decades ago wasthought to be normal. Now,
plants are in the mid 20s, upper20s, low 30s of THC content. So
(34:04):
part of our mission is toprovide real world marijuana
some of the criticism over thelast couple years from other
researchers, they could neveraccess real world marijuana.
Well, now a company like us canbring in genetics from anywhere
in the world to study it andprovide cannabis in any form
both flour, inhalable or edibleproducts exactly as provided in
(34:28):
other states. And so that storya real warm, I don't want
marijuana that goes away, we'reable to provide anything in any
form, again for for the firsttime in decades. So really first
time in history in America. Sowe're again, thankful to be in a
position look forward to leadingthe way.
Louis Celli (34:45):
And to be clear, you don't just necessarily grow
high THC content. You can alsogrow low THC content for
different applications.
Steve Groff (34:56):
Absolutely. I am a firm believer that THC sea level
does not need to be nearly ashigh as some of the products out
there in the marketplace toprovide medical benefit. I look
at some of the products anddispensaries in America right
now with 95% thc. That's likegoing to your neighborhood bar
and asking for a drink and theygive you a pint of green
(35:17):
alcohol. I mean, like that wedon't need to do that much THC
and a dose. And so I think allthese things will evolve. And I
think we'll have consistentdosing for medical cannabis
products that make sense foreverybody, and most importantly,
help people.
Louis Celli (35:34):
Before we go in, I want to make sure that that
we've covered anything that youwould consider to be relevant
and important for our listenersto hear, we always want to give
our guests the last word, isthere anything that that you'd
like to touch on that we haven'tcovered yet?
Steve Groff (35:49):
I think this was great. And I look forward to
working with you to advance thecause for access to, for
veterans for both this type ofmedicine and other plant
medicines as we go forward. Ithink it's important to know
that me personally, I'm a fan ofthe plant, I just want to see it
taken to its top level, if youwill, I think that it's I've
(36:12):
seen it in my own clinicalpractice the improvement in
1000s of people's lives. I'mpassionate about it. But also,
I'm a scientist and a physician,and I want to do it right. And I
think America can do it right.
And we will now that, again,we've had this type of movement
from the federal government.
Companies like us are driven.
We're passionate and we makethings happen. And so we want to
(36:34):
we want to help help people withthe the best medicine and the
safest pathway forward.
Louis Celli (36:44):
Dr. Goff, thank you so much for joining us today.
And we really appreciate yourtime.
Steve Groff (36:49):
It's been an honor.
And thank you.
Louis Celli (36:52):
Thank you. And that's it. That really is all
the time that we have for thisweek. Listen, join us next week.
We're going to be speaking withLisa Taylor and Carrie ward in
the Veterans History Project outof the Library of Congress. This
is an exciting program thatyou're going to want to hear
more about. So we'll see younext week.
Charlie Malone (37:14):
Thanks for listening to the policy bets
podcast. For more informationabout projects and other
podcasts. Go to policy. That'sdot org.
Interestingly, psilocybin and THC are both
very, very powerful moleculesthat have no lethal dose in
humans. We've known this foryears. He can't kill you. We've
known that there are credibleanecdotal stories of and some
early research again for bothTHC and psilocybin can help
reboot certain brain pathways. Ithink both these plants and both
(00:25):
these molecules have tremendouspotential to help with PTSD,
depression, anxiety, smokingcessation, opioid addiction.
Charlie Malone (00:38):
Welcome to Season Two of the policy vets
podcast, engaging with leaders,scholars and strong voices to
fill a void in support of PolicyDevelopment for America's
veterans. With your host formerSecretary of Veterans Affairs,
Dr. David Shulkin. And theExecutive Director of Policy
beds, Louis Celli, today's guestDr. Steve Groff founder and
(00:58):
chairman at golf North America.
Louis Celli (01:05):
Mr. Secretary, one of the advantages of doing a
podcast as often as we do themis that we really get to stay on
top of kind of breakingdevelopments fairly quickly in
the community.
Dr. David Shulkin (01:16):
Yeah, I think that's true. When it comes to
this issue that we're talkingabout today, medical cannabis,
it's hard to understand exactlywhat's going on. Clearly, I
think the states have movedvery, very quickly, the federal
government seems like is justbeing slowly pulled along. But
still a big gap in the way thatpeople can access medical
(01:41):
cannabis with state policyversus federal policy. And
frankly, it just doesn't make alot of sense. If you're trying
to get help for condition andyou want to be treated with
medical cannabis that you haveto worry about where you live,
not necessarily what the rightthing to do is.
Louis Celli (01:58):
And that being said, patients are pretty much
left to you know, selfdiagnosis, self treatment, you
know, the, the the informationthey find on the internet, or,
you know, whoever's behind thecounter at the whatever
dispensary, or or cafe theyvisit, so it's really hard to
tell, you know, that. Socannabis has been, has been
(02:21):
touted as being a promisingmedication for relief for
Crohn's disease and forepilepsy, seizures, for pain,
pain management, a whole bunchof different things. And it's
really hard for patients toknow, what strain should they
take? What's the dosage? Howoften should they take it? In
what manner should they take it?
Should they smoke it or eat itor a suppository or a tincture?
(02:41):
You know, how do they take it?
So it's, you know, I just thinkthat the federal government has
really left these patients outthere by themselves. And it's,
it's hard for them?
Dr. David Shulkin (02:55):
Well, it's one of these things that, you
know, the federal governmentcan't believe that simply
because they have it as ascheduled one that people aren't
out there using it. And so, soreally, I think, is a
dereliction of responsibility tonot allow this chemical
substance to be studied in aresearch way to be able to
(03:17):
answer those questions to, toallow veterans to be able to
speak to their doctors freelyabout this when they're cared
for in the VA. So there are awhole bunch of things that
frankly, just need to changewith this. I think that today
we're going to talk to Dr.
Groff, who is part of thatchange by being part of a new
initiative where there arefederally designated growth
(03:40):
facilities so that compoundswith good quality can be sold to
federal researchers who canstart moving forward with
answering some of thosequestions.
Louis Celli (03:57):
You know, it really makes it very difficult on the
largest health care provider inthe nation, the Department of
Veterans Affairs who has so manydifferent physicians that work
there who have a variety ofdifferent backgrounds and
experiences, and many of themare very interested in this
topic, but they are, there's agag order on them, you know,
(04:19):
because the federal governmentfinds that it's, you know, that
it's, it's illegal to use. ManyVA physicians struggle with
this. And I don't mean to betelling you, no one knows better
than you. You were really at theheart of this at a time of
transition. As a matter of fact,you were one of the first
secretaries or the firstsecretary, if I can think back
(04:40):
correctly. That issued a memo,really telling doctors Hey,
listen, you can't hold thisagainst a patient who is
behaving legally within theirstate when they come to you and
ask you for medical advice orfor you know, additional medical
treatment you can't holdCannabis use against them?
Dr. David Shulkin (05:01):
Well, it listen, even the Secretary is
very difficult to get a straightanswer from the Department of
Justice about what we wereallowed to do and what we
weren't. And so, you're right, Iwas pushing the envelope because
I just did not feel thatveterans were getting the right
care. And frankly, our doctorswere very confused. Remember,
doctors in the VA, more thanhalf the majority of our doctors
(05:24):
practice at the VA, but alsopractice another location,
typically, an academic medicalcenter, where on the days of the
week that they're outside theVA, they're allowed to talk to
their patients and prescribemedical marijuana and, and
participate in the wholecontinuum of services, where
(05:45):
then the days that they're atthe VA, all of a sudden, they
have as you described this gagorder, and that just isn't the
right thing to do for patients.
It's not the right thing to dofor the people who work in the
VA, they want to help theirveterans as much as anyone and
and knowing that they haveinformation that they can't
provide to their patients, theirveteran patients is really not a
(06:07):
good way to practice.
Louis Celli (06:10):
Now, one of the things I think we're going to
hear from Dr. Golf today is howthis is really a watershed
moment in this movement in thisindustry with cannabis and the
federal government relaxing alittle bit and starting to
invite more growers in toproduce a higher quality plant.
This, let's think ahead,couldn't this open a real
(06:31):
opportunity for the Departmentof Veterans Affairs when it
comes to scientific research?
Dr. David Shulkin (06:36):
Well, now I don't see any reason why the VA
wouldn't lean heavily into thisfrom a research perspective,
that's the reason the VA isthere to be able to step in
where the private sector has notfully addressed the needs from
either research or clinicalperspective for veterans. And
(06:57):
the big hold up in the VA forthe researchers was that they
couldn't legally obtain thecannabis in order to do the
research. Now. Now, I think thatthis is becoming much easier.
Louis Celli (07:10):
You know, one of the things that that I've
advocated for in the past is totake a look at the
infrastructure, say, of the DCVA Medical Center, right? And
why hasn't VA looked intoopening their own medical
school, because there's such ashortage of medical specialties
and physicians and they couldhome grow them. And then there'd
be a, you know, a requiredperiod of service that they
(07:32):
would serve, they could do thisas well with a research
facility, right, they couldturn, you know, one of their one
of their properties, the Air Actis looking at how many how many
unused properties they may have,they could turn one into a high
grade high end, really worldclass, medical facility that
studies cannabis, and they wouldbe world renowned for it.
Dr. David Shulkin (07:54):
First of all, I think on the medical education
side, you have to remember thatVA trains, literally the
majority of medical students andresidents in the country through
their academic affiliations. AndI think that's been a program
that has worked well. So havinghaving the federal government go
into establishing their ownmedical school. Not sure I would
(08:17):
go that direction, workingcloser with the Department of
Defense that actually, as youknow, does have its own medical
school, I think makes a lot ofsense. But on the research
facilities, I agree, I thinkthat that this is an opportunity
to have a center of excellencereally not just restricted to
(08:37):
cannabis, but all newdiscoveries related to helping
veterans. And look, we're seeinga time right now where the
President's announcing thereestablishment of the Cancer
Moonshot calling for funding ofa new agency called the Advanced
projects research health agencyor ARPA H. And, you know, doing
(09:00):
this in within the Department ofVeteran Affairs, I think makes a
great deal of sense as well,
Louis Celli (09:04):
really great point.
They just funded ARPA H withwhat $6 billion to get them
started. So they're, they'reserious about this.
Dr. David Shulkin (09:12):
Yeah, I think it's a request for funding. I
don't think that the funding hasbeen approved through Congress
yet, but certainly, there's abig push for
Louis Celli (09:19):
that. So and, you know, part of that, in addition
to cancer could certainly beaddressing the opioid epidemic
and suicide prevention. Youknow, and I think that this is
all related. Sure. So let's,let's get Dr. Groff in here and
find out where this movement isgoing. Okay. Dr. Groff, welcome
(09:45):
to the policy. That's podcast.
Hey, thanks for taking time outto join us today.
Steve Groff (09:49):
Great to be here.
It's an honor.
Dr. David Shulkin (09:51):
Dr. Graf.
This is a really interesting butalso complicated topic. Whenever
you talk about cannabis for someThey're issues that get
political, whether it's vaccinesand cannabis is no exception
with all the different thoughtson this one. So I think it's
good if you wouldn't mindstarting out by telling us a
little bit about yourbackground. And what made you
(10:13):
get involved and interested inthe cannabis industry in the
first place.
Steve Groff (10:19):
Great. Again, thankful to be here. I'm a
country boy, I grew up inPennsylvania as a Mennonite farm
boy and ultimately came, becamean orthopedic spinal surgeon and
spend most of my career as aclinician but also built a large
health system here in the midatlantic called OSS health.
Throughout my normal clinicalcareer, I saw some of the highs
(10:41):
and lows of the existinghealthcare and pharma regime and
I saw some of the negatives inlater my life, I decided to look
at some of the what I think arebetter options out there and
plant based medicines, includingcannabis, and so really excited
to be in this space and workingon a unique level.
Dr. David Shulkin (11:02):
So if I have that, right, you're, you're an
orthopedic surgeon, trained todo surgery, and yet, you've
focused on medicinal aspects ofcannabis.
Steve Groff (11:14):
I did, I had a great career, again, building an
entire health system, privatelyowned hospital and clinical
practice, we were the lastposition on hospital in the
country to open over 10 yearsago. Along the way, I, you know,
a transfermate relational eventthat happened to me, I was
struck by a bicycle, I wasstruck by a motorist on my
(11:37):
bicycle 10 years ago, is ridinga bicycle and hit a 45 miles an
hour. So I was 46, I wasincredibly healthy, I had no
medical issues, took nomedicines, and instantly I was
in the trauma unit of my ownhospital with a fractured neck
and some other fractures. AndI'm blessed to be alive and
walking now and normal. But Iwent through some really
difficult times on the otherside, as a patient coming out of
(12:01):
that. And so that was anotherfactor in my life that that
pushes,
Dr. David Shulkin (12:06):
how does that accident and the difficult times
which I assume included prettysevere pain? How does that
connect you then to the cannabisindustry?
Steve Groff (12:16):
Well, I again, I went personally through some
very difficult times coming outof that, and I didn't take a
medicine my entire life untilthat tremendous accident. And I
went through some personalchallenges. I really saw it from
the other side. And obviouslyone of the biggest issues that
facing America, and that's isthe horrible opioid crisis. And
(12:37):
I became a practicing physicianin the mid 90s. About the time
that not only Purdue pharmabrought out Oxycontin, but our
our Medicare program decided totell physicians to treat pain
more aggressively. And so thosetwo things together in my mind
really kicked off what we seenow is a devastating opioid
crisis. And so I fully believethere are far better options out
(13:01):
there. And I believe that we'llback in we'll see the cannabis
is one of those options thatonce we study this better and
know more about the thepharmacokinetics and things like
that, that we're going to beable to treat patients including
best with far better options.
Louis Celli (13:17):
I'm really excited to have you on with us today.
And I'm sure you're aware thatthis isn't our first podcast,
you know that we've done on thetopic of medical cannabis as a
matter of fact, you know, that'show we met you. We had nurse
Teresa Jackson on from AMVETSlast year who who introduced us
to you.
Steve Groff (13:33):
I was fortunate to meet her recently. She's an
incredible woman very inspiringand love from work and love to
support it.
Dr. David Shulkin (13:41):
Now, let's get right into the issues
related to medical cannabis. Andand I think that there's a lot
of people who have studied theimpacts of cannabis and the
cannabinoid system in general.
Your company has been selectedto be one of the first four
commercial growers in the nationas a federally licensed cannabis
(14:03):
Growth Facility. And so I thinkpeople are used to seeing
cannabis now in a number ofdifferent states and sort of
facilities that are growing in anumber of different states. But
this is a new development forthe federal government to have
these facilities. Can you tellus a little bit more about that
and what that means to thelistener who is trying to
(14:26):
understand what it is thatyou're doing, and we're excited
Steve Groff (14:31):
to be in this position. For 50 years, the only
federally legal cannabiscultivation took place at
University of Mississippi asmost of us are aware. Over the
last 25 years the statesindividually have been very
aggressive starting withCalifornia, and most recently,
Mississippi and their 38 medicalmarijuana programs at the state
level. None of those arefederally legal. The oversight
(14:53):
and regulations are extremelyvaried and vary from state to
state. So we see This is a hugesea change of approach from the
federal government to not onlyallow new cultivation but allow
the study of new genetics, andtruly open up the pathway to
unleash the American science andacademic world to truly study
(15:16):
this in a much better way thanit's existed for the last
several decades. So we'rehonored to be in this position,
we worked very hard over thelast two years with the FDA and
the DEA to receive thisunprecedented suite of
scheduling licenses. And nowwe're going to have research
material and manufacturing on anew level that's never existed
before that will be available tothe research community, the
(15:38):
manufacturing community andreally the rest of the world.
So,
Louis Celli (15:41):
you know, this federal, this federal
identification really shows thedifference between what science
can look like when it hasfederal oversight as opposed to
what the states currently aredoing and overseeing. You know,
before we even spoke, I went toyour website and one of the
things that that most struck methat I was most impressed with
(16:04):
was the layout of your websitelooks really more like a
commercial agriculture webwebsite, as opposed to, you
know, a cannabis or even patientcentered or focused website, it
looks more like a scientificbusiness to business type of
website.
Steve Groff (16:21):
So I come from obviously a long career in
healthcare and working withscientists and working at the
highest level on science. And sowhen I decided to enter the hemp
and cannabis space, I wanted toreally play at that same level,
we we saw the need for focus onscience and data. In cannabis.
We know the wave is coming. Wecan't deny that cannabis is a
(16:41):
massive movement across thiscountry around the world.
America has been behindcountries like Israel and Canada
and others where research ismoving much more quickly. And so
we also believe now that thisnew paradigm exists, we call it
cannabis 2.0. In America, webelieve that unleashing the
(17:01):
incredible power of the Americanscientific community will be
incredible and will help uscatch up and really lead the
world in research in this typeof plant medicine.
Dr. David Shulkin (17:11):
So Dr. Goff what when? Are you going to have
the first product available?
When When can people access it?
And does this mean now that youhave a facility like this, that
the Department of VeteranAffairs is going to be able to
get their cannabis from yourfacility or one of the other
(17:34):
three facilities to be able toconduct research and to be able
to start working with veteranson this?
Steve Groff (17:41):
Absolutely. So we hit an historic milestone last
week where we had cultivated acrop of marijuana in our
facility over the last threemonths, first time in history
outside Mississippi, and wecompleted a transaction with the
federal government in wherewhereby we sold the first crop
to the DEA and then bought itback for research and then
(18:04):
manufacturing. So this uniqueparadigm requires the federal
government to have control ofthe flower for a period of time.
And it's consistent with the UNsingle convention, something
that was not occurring over thelast 40 or 50 years with
Mississippi. So it is truly anew paradigm. The DEA leadership
were on site last week at ourfacility and it was truly
(18:25):
historic transaction. And so wehave premium cannabis material
now available, we'll continue tocultivate this was just our
first crop. We were extremelypleased with our our chemistry
of the plant with really strongTHC levels, which we think are
important for research. And butnow that this products
(18:46):
available, we completed thistransaction, we've closed the
loop on this new paradigm, wewill now continue to cultivate
and provide material forresearch and clinical study for
the VT. Not only VA but manyAmerican universities and
universities across the world.
We have grant submissions withsome of the most prestigious
universities in America now tostudy the pharmacokinetics of
(19:08):
THC for inhalation and oralingestion as well. So, again, we
see this new paradigm opening upand we're glad to be leading the
way.
Dr. David Shulkin (19:18):
So it sounds like that the applications are
really all going to be research.
There's not a plan for yourfacility to be able to provide
cannabis for veterans that wantto use it for clinical
indications.
Steve Groff (19:36):
Well, this is where we want to get the message out
and I think it's important onthis this podcast to hopefully
share and part of the challengefor us is still that the the
federal government considers aschedule one. We think that a
schedule two status is moreappropriate for cannabis flour,
no different than the opiumpoppy or the cocoa leaf. So we
(19:57):
think a next natural step wouldbe scheduled To which would open
up research tremendously, andthen allow for us to manufacture
specific formulations for groupslike veterans and hospitals and
drug companies. So we aresupporting a rescheduling to
schedule to and we think that,frankly, the paradigm that's
(20:19):
been set up for us is really thebeginning of rescheduling the
schedule to which makes sensethat the plant clearly has
medical use. It has no lethaldose, we know these things, but
we certainly need easier accessto research and manufacturing.
Louis Celli (20:34):
Yeah, I'd like to go back a second to the
secretary earlier, asked youreally what your personal story
was that you shared with us onon how you get into this? And,
you know, obviously, I thinkmany of our listeners really see
this as a cash cow, right? It'sa it's a huge money making
industry that that is, you know,it's going to be this way for a
(20:55):
very long time. But I guess myquestion is, and we talked a
little bit about this earlier inthe pre interview, why you
right? Why did the, with all ofthe federal growth facilities
out there, there are hundreds ofthem at the state level, many of
them do a spectacular job withoversight and inspections at the
state level. But why? How didyou get picked? There's only
(21:17):
four licenses that have beengranted nationwide, and you had
not grown in the past?
Steve Groff (21:23):
That's a great question. So I have been a
physician for 30 years, I'vebeen a DEA a Registrar for 30
years. Cannabis at the federallevel is part of the Controlled
Substances Act, a decades oldparadigm that exists. And that
needed to be followed to receivea controlled substance
manufacturing license at thefederal level. And so I was
(21:44):
extremely careful in the past toavoid any issues with violating
controlled substance act. And,frankly, investing or running a
state marijuana program is inviolation of the controlled
substance act. So I'm a scheduleone researcher, and approved by
the FDA and the DEA to toschedule to study cannabis,
(22:06):
looking at the antimicrobialaspects. And so when I received
that initial schedule onresearch approval, I knew that
that gave me a significantadvantage in the final round.
And we presented a very thoroughcomplete package with a
supporting team of scientistsand cultivators. And so we were
we were very pleased that wewere selected.
Louis Celli (22:26):
So just to be clear, the bottom line is that
the other applicants that youknow, that we've heard so much
about, were disqualified fromapplying for this, because they
manufactured cannabis prior tobeing given permission by the
federal government, so theyweren't even eligible to apply.
Steve Groff (22:45):
I think that's true for some of the applicants,
certainly not all of them. Butto be clear, that was a in the
final rule that came out fromthe federal government, it very
clearly stated that if you hadviolated the control subset
before you weren't going to beeligible. So I think that
certainly applied to some of theother applicants. I think there
were other reasons that I'm notaware of. But I'm just very
(23:07):
pleased that we were selected.
And it took two years of hardwork and communication. And
we're ready to move ahead andmove this whole industry forward
with tighter regulation andunderstanding of dosing and
effects that are that arescience based, and and proven in
clinical studies.
Dr. David Shulkin (23:25):
I just want to return a little bit to the
impact of this on veterans. Andif you're a veteran who's
listening and trying tounderstand what the situation is
where they may live in a statethat has legalized medical
cannabis, they may get theircare in a VA in that state where
the VA clinicians still are notallowed to offer medical
(23:50):
cannabis. They're not allowed toparticipate in the authorization
or prescription writing forcannabis. And to a veteran. This
really who's just trying to gethelp for their condition. This
is still a system that makes nosense where the federal
government in the state reallyaren't coordinated on this. Do
you see? Do you see the federalgovernment's initiative to
(24:16):
establish these growingfacilities as an indication that
they are going to try to catchup with where the states are?
Steve Groff (24:25):
I do and again, I think they want to see it under
a system of controls with withscience and data that support
safety and dosing and consistentregulations. And so there's the
federal government has a lot ofwork to do to catch up but is as
far as the veteran issue we werejust discussing. I'm a licensed
physician here in Pennsylvania.
I remain licensed and I'm veryactive in certifying
(24:46):
Pennsylvanians for the statemedical marijuana program, not
violating federal law. I simplycertify they have a condition.
I've done this for three yearswith several 1000 people and so
as it clinician I've been justastonished at the improvement in
people's lives, reducing theneed for prescription
pharmaceuticals. It's been aninspiring journey for me. And so
(25:09):
I think that we need need toclearly address this and find a
way where veterans can either becounseled as to counsel by their
own doctors to the VA, or atleast have access to a physician
or physician group like mine,where they could be certified in
a state program and have accessto this medicine that can help
change their life, save theirlife, get them away from
(25:32):
opioids, I fully support thatand that's part of our mission.
And again, doing it in a waythat's supported by science data
and legal structure.
Louis Celli (25:44):
But that really brings us to an excellent an
excellent point and part of thisconversation. Earlier you had
sent ahead a graphic that I'mhappy to, to share on our
website so that our listenerscan can look at it. And
essentially, you called it thethe cannabis spice rack. Can you
(26:05):
tell us a little bit about youknow, some of the chemical
makeup of the cannabis plant andwhy research is so important
here and you know, maybe in away that non scientists like me
can appreciate
Steve Groff (26:15):
the cannabis plant is amazing and it has hundreds
of molecules within it. And so Icame up with an idea called the
spice rack and it really helpsit's a graphic that can help
folks who are not science basedor plant based understand a
little bit you know, we look atTHC and CBD is the the two
molecules that people are mostaware of they're in the media.
And I think of those as salt andpepper if you will, and in the
(26:38):
spice rack while the other rareminor cannabinoids that are
present in lower concentrations,but could be very important.
Those are sort of the other rarespices that you would have in a
spice rack. So THC is themolecule that's psychoactive
that can cause too much we'llcertainly get you higher stone
but in the correct level and inan appropriate level THC can be
(27:01):
credibly incredibly helpful,along with CBD and hundreds of
other minor cannabinoids withinthe plant. So I think it's
important for folks tounderstand it's not just THC.
From a medical standpoint, thereare a number of molecules with
the cap within the cannabisplant that we think that can be
incredibly helpful.
Dr. David Shulkin (27:20):
You know, I can't help but thinking about
your your journey with thisindustry and watching the
federal government change. Andyou're being part of that. We're
hearing a lot about psychedelicsnow with veterans, particularly
in the treatment of PTSD. And itseems like it's a very similar
(27:41):
issue with the government beingvery restrictive on the use of
psychedelics for research andfor clinical implications. Do
you think that this is a modelthat that you're working on now
with cannabis that thegovernment is going to repeat in
the psychedelic industry?
Steve Groff (28:02):
My personal feeling is, is yes. And obviously we're
talking about another scheduleone molecule psilocybin that
comes from a number of naturalmushrooms. And so interestingly,
psilocybin and THC are bothvery, very powerful molecules
that have no lethal dose inhumans. We've known this for
years, you can't kill you. We'veknown that there are incredible
(28:23):
anecdotal stories of and someearly research again for both
THC and psilocybin that can helpreboot certain brain pathways. I
think both these plants and boththese molecules have tremendous
potential to help with PTSD,depression, anxiety, smoking
cessation, opioid addiction. Andso to be clear, we're pursuing a
(28:46):
similar path with the federalgovernment for the natural
production of these mushrooms tostudy them further in a similar
paradigm that we're doing incannabis. And so it's a great
question. And I'm equallybullish on both these platforms
in helping change the paradigmof pharma in America. And I
(29:07):
think that there's tremendouspotential and we're very active
in it. As well,
Louis Celli (29:14):
one of the things that that has frustrated me for
a long time and I've mentionedthis on the podcast before is
really the current legal limbostate that Canvas falls into at
the moment, you know, theuniversal lack of medical
specification in theprescription of the plant to a
patient patients have noscientific direction whatsoever
(29:36):
on things like dosage or ormethod of application or what
type of strand or whether theyneed all the chemicals contained
in the plant or just one or twothat could be separated out to
address a specific ailment. Howmight this change the basis of
the federal government'sideology on how to study this? I
(29:57):
mean, is this going to improvemedicine Do you See this, as a
federal government starting tomove toward a more liberal
attitude toward cannabis.
Steve Groff (30:07):
I think it's the beginning of a scientific
approach. The federal governmentdoes not want to legalize
cannabis at the federal leveluntil we know more about it. And
as you've mentioned, I'vewatched these 1000s of people in
my own clinical practice inPennsylvania, improve their
lives do incredibly well. Butthe biggest challenge for them
is to go to a dispensary, andthey have no idea what dose to
(30:30):
take, they have no idea whatproduct to take. And they'll
pick a product and then go backin two weeks, and that won't be
there anymore, it'll be gone.
And so we've made wonderfulstrides in cannabis availability
and some early research. Buttruly over the next five or 10
years, I believe companies likeourselves and others that are
committed the science and datawill help come up with the exact
(30:51):
dosing with pharmacokineticsthat all this work needs to be
done, and it's going to beaccelerated very quickly. Again,
we're working with a number ofuniversities right now on Grant
submissions. There's a lot ofextra funding coming from NIH
and Nida. Now to study this, thegovernment's aware of the wave
that 38 states have thisavailable already, they need to
(31:12):
catch up quickly. And so I thinkwill be an important part of
bringing this new science anddata and dosing, which is an
important topic.
Dr. David Shulkin (31:25):
It does sound Dr. Broth like this is really
threshold time where we're we'regonna see some real advances in
our knowledge and applicationsof cannabis that haven't
happened for decades. And you'rean important part of that and
being able to make thisavailable and be a resource for
(31:47):
those who want to learn moreabout this. So we very much
appreciate your time andspending time educating our
listeners here on the policybets podcast,
Steve Groff (32:00):
it's been an honor, I look forward to working with
you and
Louis Celli (32:03):
so before we go, I just I want to give our
listeners really a mentalpicture of what a regulated
federal Growth Facility mightlook like, can you share a
little bit you know, the theoversight, the inspections, the
waiting a little you know,things like that, so that they
know that it This isn't someoneyou know, this isn't something
(32:23):
that's being, you know,haphazardly grown in a field,
right? There's, there's a very,very scientific method to to
producing an exact plant.
Steve Groff (32:34):
Absolutely. We take this very seriously. We have a
world class team. We have an80,000 square foot facility like
any other cannabis facility inAmerica, we have high level
security that's required by theDEA especially to be scheduled
one. So we have security tobegin with. Then we have a grow
room that's more like anoperating room, if you will, we
(32:56):
have tightly controlledenvironmental factors lighting.
We have a top notch cultivationteam, we have testing equipment
to study the plant to understandexact potency. So we have things
like HPLC and GC Mass Spec, wein other words, high level
analytical equipment. We've gotextraction equipment, we use co2
(33:18):
extraction. So we have a team ofagain, great scientists and
cultivators and executives andworking together to really
provide world class cannabis forfor research and manufacturing.
Louis Celli (33:34):
So this isn't the same cannabis one would have
found, say at Woodstock.
Steve Groff (33:39):
No, I don't think so. Obviously, it's evolved in
over the last 20 or 30 years,again, led by California, I
mean, the genetics have beenhave been tweaked if you will, I
mean, five or 10% thc. From someof the early Mississippi
marijuana from decades ago wasthought to be normal. Now,
plants are in the mid 20s, upper20s, low 30s of THC content. So
(34:04):
part of our mission is toprovide real world marijuana
some of the criticism over thelast couple years from other
researchers, they could neveraccess real world marijuana.
Well, now a company like us canbring in genetics from anywhere
in the world to study it andprovide cannabis in any form
both flour, inhalable or edibleproducts exactly as provided in
(34:28):
other states. And so that storya real warm, I don't want
marijuana that goes away, we'reable to provide anything in any
form, again for for the firsttime in decades. So really first
time in history in America. Sowe're again, thankful to be in a
position look forward to leadingthe way.
Louis Celli (34:45):
And to be clear, you don't just necessarily grow
high THC content. You can alsogrow low THC content for
different applications.
Steve Groff (34:56):
Absolutely. I am a firm believer that THC sea level
does not need to be nearly ashigh as some of the products out
there in the marketplace toprovide medical benefit. I look
at some of the products anddispensaries in America right
now with 95% thc. That's likegoing to your neighborhood bar
and asking for a drink and theygive you a pint of green
(35:17):
alcohol. I mean, like that wedon't need to do that much THC
and a dose. And so I think allthese things will evolve. And I
think we'll have consistentdosing for medical cannabis
products that make sense foreverybody, and most importantly,
help people.
Louis Celli (35:34):
Before we go in, I want to make sure that that
we've covered anything that youwould consider to be relevant
and important for our listenersto hear, we always want to give
our guests the last word, isthere anything that that you'd
like to touch on that we haven'tcovered yet?
Steve Groff (35:49):
I think this was great. And I look forward to
working with you to advance thecause for access to, for
veterans for both this type ofmedicine and other plant
medicines as we go forward. Ithink it's important to know
that me personally, I'm a fan ofthe plant, I just want to see it
taken to its top level, if youwill, I think that it's I've
(36:12):
seen it in my own clinicalpractice the improvement in
1000s of people's lives. I'mpassionate about it. But also,
I'm a scientist and a physician,and I want to do it right. And I
think America can do it right.
And we will now that, again,we've had this type of movement
from the federal government.
Companies like us are driven.
We're passionate and we makethings happen. And so we want to
(36:34):
we want to help help people withthe the best medicine and the
safest pathway forward.
Louis Celli (36:44):
Dr. Goff, thank you so much for joining us today.
And we really appreciate yourtime.
Steve Groff (36:49):
It's been an honor.
And thank you.
Louis Celli (36:52):
Thank you. And that's it. That really is all
the time that we have for thisweek. Listen, join us next week.
We're going to be speaking withLisa Taylor and Carrie ward in
the Veterans History Project outof the Library of Congress. This
is an exciting program thatyou're going to want to hear
more about. So we'll see younext week.
Charlie Malone (37:14):
Thanks for listening to the policy bets
podcast. For more informationabout projects and other
podcasts. Go to policy. That'sdot org.
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