Researching Medical Marijuana and PTSD: Dr. Sue Sisley on the Quest to Expand Research on the Medicinal Potential of Cannabis

Sue Sisl ey

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Margaret Flinter: Welcome to Conversations on Health Care with Mark Masselli , and
Margaret Flinter , a show where we speak to the top thought leaders
in health innovation, health policy, care delivery and the great minds
who are shaping the health c are of the future. This week , Mark and
Margaret speak with Dr. Sue Sisley , President of the Scottsdale
Research Institute dedicated to conducting empirical FDA approved
studies on the efficacy of the marijuana plant for treatment of
posttraumatic stress di sorder in veterans and others. She outlines the
odyssey s he's had to endure to gain approval for her research .

Lori Robertson also checks in , the Managing Editor of FactCheck.org
looks at misstatements spoken about health policy in the public
domain separa ting the fake from the facts . And we end with a bright
idea that’s improving health and well - being in everyday lives.

If you have comments , please e - mail us at [email protected] or find
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You can also hear us by asking Alexa to play the program
Conversations on Health Care . Now stay tuned for our interview with
Dr. Sue Sisley President of the Scottsdale Research Institute on
Conversations on Health C are .

Mark Masselli : We're speaking today with Dr. Sue Sisley , Arizona based physician
practicing in internal medicine in psychiatry, President of the
Scottsdale Research Institute . Dr. Sisley is the site principal
investigator in the only FDA approved rand omized control trial in the
world, examining the safety and efficacy of the whole plant marijuana
and combat veterans with severe posttraumatic stress disorder or
PTSD. She's an institutional member of the American Telemedicine
Association. Dr Sisley earne d her medical degree at the University of
Arizona College of Medicine and completed her residency training at
Good Samaritan Regional Medical Center in both internal medicine
and psychiatry. Dr Sisley, welcome to Conversations on Health Care.

Dr. Sisley: O h, thank you.

Mark Masselli : You know as a nation we're in this midst of several concurrent public
health issues. We have this huge unmet behavioral health care need
and tragically we're experiencing an epidemic of suicides in our
nation's veterans popula tion , a nd we're also in the throes of a deadly
opioid crisis . You've experienced the confluence of all of these
firsthand , and I'm wondering if you could talk about the scope of the
problem and how it galvanized the focus of your research in
examining medi cal marijuana as a vital untapped resource?

Dr. Sisley: Yeah. I would start with the issue that, you know we don't see a ton of
pharmaceutical innovation s around the problem of PTSD. So there has

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not been a single new FDA approved medication for PTSD in 17 years
if you can believe i t . The only two medications that have actually been
approved by the FDA specifically for treating PTSD is Zoloft and Paxil .
When those medications don't work, inevitably these patients get
pummeled with all these different prescr iptions , s o that was what
spurred us to do this work was we realized we desperately need new
treatments for PTSD . So since we had this mountain s of anecdotal
evidence from patients, particularly military veterans, but all sorts of
patients were coming forw ard claiming that they were getting benefit
from this plant . I was very skeptical, when they first started disclosing
to me about 15 years ago that they were using this plant to treat a
variety of ailments , I was really dubious because I've been trained in a
really conservative medical environment where you don't view
anything as a medicine unless it's been put through the entire FDA
drug development process. So , it took me years of hearing their
reports, especially collateral history from other family memb ers that
were confirming that this plan t was benefiting their loved one , and it
took me a long time to really view this plan t as a medicine.

Finally when you look at the scientific literature , there was already
thousands of controlled trials that had alrea dy been published in peer
reviewed medical journals that were suggesting that cannabis had
benefits. I would say I'm still a skeptic , I'm a scientist so until we see
data from randomized controlled trials it's going to be tough for me,
but the bottom line is, yeah, we do have an epidemic of veteran
suicide and suicide in general in CDC data . It is really concerning for all
of us in the medical community because we don't have enough tools
in the arsenal to deal with this.

We've got some very mediocre pharma ceuticals that target maybe
one symptom or another but don't really target the whole
constellation of symptoms w hether it's depression, anxiety, PTSD all
of these things that are promoting suicidal thinking . The opioid
epidemic is all part of that where t h e reason people are turning to
opioid isn't just to treat pain . The opioids have a natural biologic anti -
depressant action so because opioids elevate people's mood, you see
a lot of people abusing opioids who aren't treating pain at all but are
treating lo ngstanding depression, insomnia, other things that are
being quelled with opioids. There is really impressive trends that
we're seeing in legal medical cannabis states showing that patients
who have cannabis as a safer alternative to opioids are choosing
c annabis and their lives are being saved by that . We need to study
this much more vigorously through controlled trials but given the
seriousness of this opioid crisis , it's sad to me that we're not studying
cannabis more vigorously because it seems to hold a lot of promise.

Margaret Flinter: Well Dr. Sisley, you said it's been about 15 years that you've been
hearing the stories and I know over the past decade you've been on a

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quest to advance research on the use of medical marijuana in this
country and I hav e also read about the barriers you faced or had to
seek approval from the FDA , the DEA , other government entities to
launch a research study and then had the challenge of gaining access
to the government approved cannabis to use in the study. Tell us
about these challenges to research , and what's the gap in the
research that you are seeing that you feel you and your colleagues
need to address in order to advance our understanding?

Dr. Sue Sisley: I think we all agree that cannabis being lumped into Schedule 1 is
absurd in the first place. Schedule 1 drugs are drugs that the
government deems have no medical benefit and severe addiction
potential and cannabis doesn't meet either of those criteria. What's
even more insane is that cannabis has more onerous barri ers to
research than any of the other drugs in Schedule 1 . And we know this
firsthand because MAPS a nonprofit that does all the seminal studies
on psychedelics over the last 30 years , t hey've been attempting to do
MDMA research side by side with cannabis research . It's amazing that
it's easier for them to study MDMA than it is cannabis because there's
several additional layers of government red tape that cannabis has
been forced to deal with. For instance, this public health service
review that's been in p lace fo r four decades after we already had FDA
approval , in our case that delayed our study implementation for three
years for no reason.

We managed to dismantle that with the aggressive lobbying but the
most severe barrier to research is still this NIDA m onopoly the fact
that you do have to buy cannabis study drugs from the University of
Mississippi that there's still only one federally legal supply of
candidates for any of these controlled trials. None of the other drugs
in Schedule 1 have to go through a monopoly . When MAPS purchases
MDMA for their studies they can buy MDMA or LSD or psilocybin
mushrooms from any research lab in the country , t hey don't have to
go through NIDA. For instance, if you're studying the efficacy of
cannabis for a certain illness , t raditionally NIDA has not appreciated
studies looking at efficacy because the government has already told
the public that c annabis has no medical benefits. In our case
f ortunately we had a ton of public support and the who le veterans
community behind us .

Mark Masselli: But y ou did run into some red tape on that as well , and in your pursuit
you finally received that government sanctioned research cannabis
from Mississippi. I forget if I read it correctly, it was frozen and you
had endured a considerable b acklash after calling attention to the
problem . Your partnership with the University of Arizona came into an
end and then you picked yourself up and join ed forces with Colorado
State University , and that's a state with the most liberal marijuana
laws in th e country . There seems to be a shifting tide in the nation's

Sue Sisl ey

marijuana laws and I'm wondering if you could talk a little bit about
the shift to our listeners and what should researchers be considering
as more states approve medical marijuana laws and as ap parently
more corporate entities seem eager to enter the industry.

Sue Sisley: There's many public universities that are still running scared from this
work e ven though the studies that we're doing are all federally legal.
When you do controlled trials on Cannabis, you're getting FDA
a pproval, IRB Committee a pproval, and then of course the DEA
Schedule 1 license to purchase Cannabis from the government. So all
these three [PH] are legal, but yet universities are still fearful because
they think it'll har m t heir federal grant dollars and that we have
examples of tons of public universities that are already doing this
work. Sadly it shouldn't take any political courage to do this work, but
if you function in a really conservative states and you want your
unive rsity to do c annabis research, then you probably have a struggle
trying to do that work in those states , and yeah that's why we ended
up getting funding from Colorado. The State of Colorado chose to
fund the study at $2.1 million but they allowed us to con duct the trial
in Arizona. Luckily with funding from Colorado, we were able to
complete the trial and it's been 10 years saga trying to get this study
completed through immense public support. We've managed to get
this thing across the finish line, so the final veterans will be
completing the protocol in end of January we should be unblinding all
the data sometime in March . So the good and the bad of cannabis will
all be published to try to get this information out to the public.

Mark Masselli: I think our listeners would be interested in hearing about how you
constructed the study to produce that empirical data that you all have
b een working so hard to attain. Tell us more about the specifics of the
study. What kind of measures are you looking at?

Sue Sisle y: The study is actually a triple blind randomized controlled trial, which
is one of the ways that we've attempted to eliminate any chan ce of
human bias. In this case the study subjects are all blinded , t hey have
no idea what variety of cannabis they're re ceiving c ould be placebo,
could be high THC or high CBD , t he physician investigators like me
don't have any idea what anybody's getting. Finally the triple blind is
the a ll these secondary tests that we're doing, all these independent
raters are also blind ed . And we deliberately decided on that design
because the amount of effort it's taken us to get the study
implemented and completed . W e wanted to just do the work and get
the data and get it out to the public. So that's why we were concerned
that the publ ic might perceive that we have some type of agenda here
and we don't, I mean that's the one thing I really want to emphasize
here. Our commitment is to getting the most objective on a saleable
data and really understanding how does this plant work, how doe sn’t

Sue Sisl ey

it work , where it is potentially detrimental to patients and put all of
t he data into the public domain.

We're a nonprofit so our commitment is trying to put all the data out
there, the good and the bad , so everybody can understand does this
plan t he lp with PTSD? And, and if not, then let's abandon this because
right now the data is conflicting. So that's why we needed a definitive
controlled trial to answer this more clearly. If the data shows that
cannabis is potentially beneficial then trying to id entify which strains
or varieties might be best for treating this, that's another problem.
And the biggest void I see is what we call strain science is trying to
understand which strains or which phenotypes of cannabis are best
for which illnesses. And I'm sure your listeners are aware that you
know there's hundreds of different varieties of cannabis and all of
them have different clinical properties, so trying to understand that
which ones are best for which illnesses is crucial.

Mark Masselli: We're speak ing today with Dr. Sue Sisley, President of the Scottsdale
Research Institute, practicing in internal medicine and psychiatry. Dr.
Sisley is the site principal investigator in the only FDA approved
randomized control trial and the world examining the safet y and
efficacy of the whole plant marijuana in combat veterans with severe
posttraumatic stress disorder . Dr. Sisley , w hile your current focus is
cannabis and PTSD t he Scottsdale Research Institute is seeking to
advance a much larger scale studies on a num ber of other conditions,
potentially treating everything from multiple sclerosis to Alzheimer's.
Could you help us understand more about the chemical compounds
found in marijuana? Why it appears potentially promising for so many
conditions, especially diso rders of the brain in the nervous system?

Sue Sisley: W ell, the plant is so complex. We always talk about THC and CBD
because they've been the best characterized so far , w e know the
most about them . But there's 100 plus other cannabinoids that have
been id entified that we don't understand what is their clinical effects
and how to harness them . So that part of the research that's been
blocked for so many decades c ould have, we could have kno wn so
much more about this plant by now . But ideally if the work tha t we're
trying to do to break this monopoly to license other expert growers
for research is so essential to enablin g the understanding of the plant
to move fo rward b ecause right now the genetics that the university of
Mississippi has is so limited. A lot o f interested in looking at other
diverse cannabinoids like THCV or CBN or CBG and these are all thin gs
that we can't currently get. So I'm hoping that you'll see a renaissance
of cannabis research in this country where we can finally learn more
about what all these other molecules do ; terpenes and flavonoids and
all these molecules that are working synergistically in the plant to

Sue Sisl ey

create what we call the entourage effect. But even that needs to be
studied further to unders tand how to really harness that.

Mar garet Flinter: Dr. Sisley, in addition to all of your focus and work on advancing
scientific research for medical marijuana, I know that you've also been
very engaged as an early adopter of t elemedicine in your clinical
practice for almost a decade. Can yo u talk with us a bit about your
experience utilizing t elemedicine and your perspective on how it may
or may not have reduced barriers to care and lead to better
outcomes?

Dr. Sue Sisley: You know here in Arizona, we've got patients that are so remote ,
ther e are five, six hours away from the main city centers and over
30 % of our land in Arizona is tribal lands , Native American populations
that are really underserved on medical care. So in those cases,
t elemedicine is the only method of getting care to them , and it's been
a wonderful experience. At first , I was concerned that I wouldn't be
able to have that kind of rapport that you get from being in an exam
room with the patient one - on - one . But I've been amazed at how well
we can build that type of really high quality doctor - patient
relationship even over video, and provide some really excellent
medical care s because now we have all these different modalities. We
have digital stethoscopes, digital otoscopes, all sorts of digital
cameras to take pictures and fol low people. If somebody has a skin
lesion, I can follow it continuously to see how it's progressing or
regressing. I have the ability, I'm obviously reviewing people's lab
results electronically and I can guide them easily on things like their
diabetes car e, their hypertension. So I found it really rewarding , I feel
like the patients who are getting care from such remote areas are
super grateful for the fact that anybody is even able to pay attention
to them and their needs , a nd so it's been really rewardin g .

We're finding uses in other crucial areas , j ust public health issues like
correctional care, providing care in the prisons and jails has been
really important because their access, especially to specialty care has
been very limited . It's been the source of a lot of lawsuits for these
states, but t elemedicine has stepped in those areas and been really
useful.

Mark Masselli: We've been speaking today with Dr. Sue Sisley, President of the
Scottsdale Research Institute and site principle investigator in the only
FDA approved randomized controlled trial in the world examining the
safety and efficacy of the whole plant marijuana in combat veterans
with PTSD. You can learn more about her work by going to
www.sriresearch .org or you can follow her on twitter @ Sue Sisley
[PH] , S - I - S - L - E - Y . Dr. Sisley, thank you for your scientific dedication
and perseverance and for joining us today on Conversations on Health
Care .

Sue Sisl ey

Dr. Sue Sisley: Thank you so much.

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Mark Masselli: At Conversations on Health Care, we want our audience to be truly in
the know when it comes to the facts about health care reform and
policy. Lori Robertson is an award - winning journalist and Managing
Editor of FactCheck.org, a nonpartisan, nonprofit consu mer advocate
for voters that aim to reduce the level of deception in U.S. politics.
Lori, what have you got for us this week?

Lori Robertson: The Accountable Care Act open enrollment period for most states
runs from November 0 1 to December 15. These are th e 39 states
using the www.healthcare.gov platform and the sign - ups are for
insurance plans that began in January 2019, the first year in which the
individual mandate penalty will no longer be in effect. That's the
penalty assessed if someone doesn't have insurance or qualify for an
exemption from the penalty.

So how many people have signed up for insurance so far? From
November 0 1 through the 17, 1.9 million people have selected
insurance plans according to the Cen ters for Medicare and Medicaid
Services, which releases weekly updates during the open enrollment
period. Those 1.9 million people included nearly 1.5 million
consumers who are renewing their coverage and nearly 500,000 who
are new consumers for www.healthcare.gov plans. The total number
is down a bit from last year when nearly 2.3 million had s elected plans
from November 0 1 through the 18, a similar time period , a ll told plan
selections are down by 352,603 compare d with last year.

The open enrollment again runs until December 15 and the Centers
for Medicare and Medicaid Services won't release a final report on
the total enrollment for ACA exchange plans in all states for several
months. In last year's open enrollme nt period, a total of 11.8 million
people selected or were reenrolled in exchange plans. That includes
8.7 million people in the www.healthcare.gov states and another
three million in states that use their own enr ollment systems. That
total figure was down by 400,000 from the previous year. Since the
ACA exchange i s launched for the 2014 plan year, the total enrollment
peaked at 12.7 million people for ins urance plans in effect for 2016.
That's my fact check for th is week. I'm Lori Robertson, Managing
Editor of FactCheck.org.

Margaret Flinter: FactCheck.org is committed to factual accuracy from the country's
major political players and is a project of the Annenberg Public Policy
Center at the University of Pennsylva nia. If you have a fact that you'd
like checked, e - mail us at www.chcradio.com . We'll have
FactCheck.org's Lori Robertson check it out for you here on
Conversations on Health Care.

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[Music]

Margaret Flinter: Each wee k Conversations highlights a bright idea about how to make
wellness a part of our communities and everyday lives. Stanford
based bioengineer Manu Prakash has a simple goal. He wants to
create portable medical labs, small enough to fit in a backpack, and
he 's already deve loped a tool that fits the bill. While sitting under a
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Manu Prakash: We spent a significant portion of this time truly understanding the
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Margaret Flinter: So he took this simple toy idea to another level , creating a human
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Manu Prakash: With the set of principles, we're able to essentially make a centrifuge
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Margaret Flinter: The Paperfuge , a cheap but highly effective field tool [PH] for
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bright idea.

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Mark Masselli: You've been listening to Conversations on Health Care. I'm Mark
Masselli.

Margaret F linter: And I'm Margaret Flinter.

Mark Masselli: Peace and health.

Conversations on Health Care is recorded at WESU at Wesleyan University, streaming live at
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please e - mail us at [email protected] or find us on Facebook or Twitter. We love hearing

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from you. This show is brought to you by the Community Health Center.
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