AFFIDAVIT

OF SUZANNE SISLEY, M.D.

The affiant, being duly sworn and of lawful age, testifies as follows:

1. My name is Suzanne Sisley, M.D. I graduated from the University of Arizona
College of Medicine in 1995 and, my practice specializes in the fields of
psychiatry and internal medicine. I am also former assistant clinical professor at
the University of Arizona College of Medicine.

2. I have developed a subspecialty in treating survivors of Post Traumatic Stress
Disorder (PTSD) and have treated veterans for approximately twenty years,
including treating veterans with PTSD at the Veterans Administration hospital in
Phoenix, Arizona and in my own private practice.

3. In 2015 I gave a presentation at the Walter Reed Military Medical Center
summarizing the current state of research and outlining the potential for
medicinal cannabis to be used to treat veterans with PTSD. I have also been
active in developing clinical studies to examine the potential of cannabis to treat
PTSD symptoms.

4. On July 15, 2015, I traveled to Denver, Colorado in order to testify in front of the
Colorado Board of Health (the Board) in order to present testimony concerning
the treatment of PTSD with medicinal cannabis. Unfortunately, the Board only
permitted me to testify for two minutes. I believe this was an abuse of the
Boards discretion, because, as explained below, I have received substantial
grants to study the potential use of medical cannabis to treat veterans suffering
from PTSD, and in connection with designing this research and securing funding
I have developed a unique and highly specialized set of skill, experience,
knowledge and training in this area.

5. My research and the current state of medical knowledge in this area are based
on complex scientific and medical concepts that simply cannot be distilled into a
two-minute presentation. With all due respect to the Board, I believe that their
decision to limit my testimony to two minutes was arbitrary and capricious and
an abuse of the Boards discretion. In effect, I believe that the Board chose to
remain willfully ignorant of the current state of medicine in this area when they
declined to grant me a reasonable amount of time to testify regarding these
complex issues. The purpose of this affidavit is to summarize some key points I
would have made if the Board had granted me a reasonable amount of time to
testify at the July 15, 2015 hearing (the Hearing).

6. During and after the Hearing certain Board members stated that they wanted to
see the results of a randomized, blind study on the effects of medical cannabis in
PTSD prior to adding PTSD to the list of conditions for which Colorado
physicians may properly recommend medical cannabis. For the past several
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years I have been designing and securing funding and government approval for
just such a study. Under these circumstances I believe it was a clear abuse of
discretion for the Board to decline to hear my testimony regarding an issue that
members of the Board defined as critical to their decision making process. This
is particularly true since the Colorado Department of Public Health and the
Environment (CDPHE) has agreed to provide a grant of $2,156,000.00 to fund
the study I will be leading.

7. C.R.S. 25-1.5-106.5 establishes a CDPHE-governed research grant program to
facilitate objective scientific research regarding the efficacy of marijuana and its
component parts as part of medical treatment. 5 CCR 1006-2, Regulation 14
further details the CDPHEs medical research grant program.

8. As noted above, the CDPHE has agreed to provide $2,156,000.00 in funding for a
Placebo-controlled, Triple-Blind, Randomized Crossover Pilot Study of the Safety
and Efficacy of Four Potencies of Smoked Marijuana in 76 Veterans with Chronic,
Treatment- Resistant Post Traumatic Stress Disorder. I will act an Investigator
for this study in connection with Marcel Bonn-Miller, an adjunct assistant
professor of psychology in psychiatry at the University of Pennsylvania, Dr. Ryan
Vandrey, an associate professor in the Behavioral Psychology Research Unit at
Johns Hopkins University, researchers from the University of Colorado and the
Multidisciplinary Association for Psychedelic Studies (MAPS).

9. But sadly, the CDPHE money has not been utilized yet despite being awarded in
December 2014. Due to delays from layers of federal government red tape
published data from this study will not be available to the public for
approximately four years.

10. The data from the study I will be leading reaches the level of rigor that the Board
was demanding, but the study was submitted to the FDA in 2010 and will not
have published data until approximately 2019. This is evidence of the way
marijuana efficacy research has been systematically impeded in the U.S.
Demanding randomized controlled trials before medical marijuana can be
recommended to treat PTSD under Colorado law is an unreasonable standard
because it cannot be attained in a reasonably timely manner, and does not
address the immediate needs of PTSD patients. While the government delays,
thousands of individuals suffer needlessly.

11. My research proposal received the approval of the U.S Food and Drug
Administrationa high hurdle, since marijuana is still categorized as a Schedule
1 drug by the federal governmentand the University of Arizona Institutional
Review Board in March of 2015. It became the first whole-plant medical
marijuana drug development research project to obtain approval from the U.S.
Department of Health and Human Services to purchase marijuana from the

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National Institute on Drug Abuse, which has a monopoly on marijuana used for
federally-approved research in this country.

12. The evidence presented at the July 15, 2015 Hearing included research
conducted between 2009 and 2011 in New Mexico--the first state to authorize
treating PTSD with medical cannabis--which reported a 75 percent decrease in
three major PTSD symptoms in patients. This research used the VA-approved
Clinically Administered PTSD Scale (CAPS) method, which studies the
presences of PTSD experiences and the patients responses to them, and
supports a conclusion that using medical marijuana is associated with PTSD
symptom reduction in some patients. This peer-reviewed study was published
in a recent special issue of the Journal of Psychoactive Drugs. See George R.
Greer, Charles S. Grob, Adam L. Halberstadt. PTSD Symptom Reports of Patients
Evaluated for the New Mexico Medical Cannabis Program, Journal of Psychoactive
Drugs, 2014; 46 (1): 73 DOI: 10.1080/02791072.2013.873843.

13. A second study discussed at the Hearing concluded that, [w]hile further
research into cannabinoid treatment effects on PTSD symptoms is required, the
evaluated evidence indicates that substantial numbers of military veterans with
PTSD use cannabis or derivative products to control PTSD symptoms, with some
patients reporting benefits in terms of reduced anxiety and insomnia and
improved coping ability. Use and effects of cannabinoids in military veterans
with posttraumatic stress disorder Betthauser K, et al. Am J Health Syst Pharm.
2015.

14. Both of these studies are consistent with the testimony presented at Hearing
medical marijuana is effective for treating PTSD for many patients suffering from
the condition.

15. More than 50 members of the public presented testimony at the July 15, 2015
hearing, and only two individuals, without scientific data, testified against the
addition of PTSD to the qualifying list.

16. Despite the Medical Marijuana Scientific Advisory Council (MMSAC) and
CDPHE Executive Director and Chief Medical Advisor Dr. Larry Wolks
recommendation and support, the Board denied the Petition following the July
15, 2015 hearing by a vote of six to two against, citing a lack of sufficient
scientific evidence.

17. The CDPHE and the Board have never granted a petition to add a debilitating
condition, and have denied at least 13 such petitions since 2001.

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18. The Board denied the Petition in part because the addition of PTSD was not
supported by a randomized controlled study. But this establishes an arbitrary
and unattainable standard because the federal government has refused to allow
the grant-approved work of myself and Marcel O. Bonn-Miller to move forward.
Thus, the Board made a decision based upon a standard that cannot currently be
attained, leaving PTSD patients to suffer in the meantime.

19. At this time the FDA has only approved two drugs to treat PTSD, the selective
serotonin reuptake inhibitors commonly known as Zoloft and Paxil. Physicians
regularly prescribe other drugs that are not FDA-approved for the treatment of
PTSD off-label, including anti-anxiety medications like the benzodiazepine
Xanax. All of the pharmaceutical drugs that physicians prescribe for PTSD have
significant side effects. In short, permitting Colorado physicians to recommend
medicinal cannabis for PTSD patients would be analogous to the practice of
physicians using their clinical judgment to prescribe pharmaceutical drugs offlabel for treatment of PTSD.

20. Our bodys own endocannabinoid system binds with cannabinoids in cannabis.
The endocannabinoid system helps to regulate, inter alia, sleep, anxiety and
responses to stressful situations. Current research and anecdotal evidence from
a large number of patients indicates that medical cannabis can be effective for
treating PTSD symptoms including anxiety, insomnia, depression, nightmares
and problems with self-regulation.

21. Whole plant cannabis contains two major active constituents, THC and CBD, in
addition to numerous other compounds. Because both CBD and THC have antiinflammatory properties, cannabis may confer benefit in the treatment of PTSD
through reduced inflammation. Preclinical studies in rodents suggest
cannabinoids reduce fear, and research in mice found that CBD was comparable
to the antidepressant imipramine in tests of antidepressant-like effects.

22. The following states have approved PTSD as a qualifying condition for their
medical marijuana programs: Arizona, California, Connecticut, Delaware, Maine,
Maryland, Massachusetts, Michigan, Nevada, New Mexico, and Oregon. The
territory of Guam and Washington D.C. also permit use of medical marijuana to
treat PTSD symptoms.

23. Arizona recognized medical marijuana as a legitimate treatment for PTSD
following the decision in In re Arizona Cannabis Nurses Assn., 2014A-MMR-0254DHS (AZ Office of Admin. Hearings, June 4, 2014). In that case, Administrative
Law Judge Thomas Sheddon held that testimony demonstrating that patients
suffering from PTSD received a palliative effect from medical marijuana
coupled with the New Mexico study referenced above and testimony that
prescribing medical marijuana was consistent with clinicians use of other offlabel drugs to treat PTSD--was sufficient to meet the Appellants burden of
proof to list PTSD as a qualifying condition.
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24. In 2010 Dr. Robert Petzel, the Under Secretary of Veterans Affairs issued a
Directive that acknowledged the medical value of cannabis and directed VA
physicians that they could continue to provide treatment to Veterans who use
cannabis as long as they live in a state with a medical cannabis law and have a
recommendation for cannabis from a civilian physician. This Directive was
updated in 2011. This is good news for some Veterans, but we now have a policy
of treatment by geography and that is not fair for Veterans who risk their lives
for their country.
25. Currently a Veteran commits suicide every 65 minutes or 22 suicides each day.
Many of these Veterans have difficulty living with PTSD, or traumatic brain
injuries, or severe pain from combat-related injuries, or the side effects of the
many pharmaceuticals they are often prescribed.

26. To summarize, I believe that if I had been permitted an adequate amount of time
to testify at the Hearing that I would have been able to effectively address the
concerns of the two Board members who voted against adding PTSD as a
qualifying condition for medical marijuana recommendations and explain why
the Boards decision to wait years for the results of my study or similar studies
unnecessarily prevents qualifying individuals from potentially achieving relief of
their PTSD symptoms by using medical marijuana.

27. I would have also provided an overview of the current pharmaceutical
treatments available to treat PTSD and described some of the most common
pharmaceutical drugs and their side effects. I then would have summarized the
existing literature regarding the use of medicinal cannabis to treat PTSD and
discussed potential side effects of medicinal cannabis, explaining that the
existing research and anecdotal evidence indicate that medicinal cannabis
compares favorably to pharmaceutical drugs currently used to treat PTSD in
terms of effectiveness and side effects. This compels the conclusion that
physicians in Colorado should be permitted to use their clinical judgment to
decide whether to recommend medicinal cannabis to treat PTSD, similar to
physicians in many other states. I believe that had I been permitted to present
this testimony I would have been able to address the concerns of the two Board
members who voted against the petition to add PTSD as a qualifying condition
for medical marijuana recommendations and that the Board would have
approved the petition.

28. This Affidavit summarizes the testimony that I would have offered to the Board,
and that I will offer to this Court if I am permitted to testify in the Bean v. CDPHE
lawsuit currently pending in the Denver District Court. I would welcome the
opportunity to present live testimony in order to explain the current state of
scientific and medical research regarding the use of medicinal cannabis to treat

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PTSD and answer any questions that the Court may have regarding these
complex issues that affect the thousands of individuals living in Colorado who
suffer from PTSD.




Further affiant sayeth naught.

/s/ Suzanne Sisley, M.D.





Suzanne Sisley, M.D.













Subscribed and Sworn by Suzanne Sisley, M.D. before me, a notary public, this 11th
day of January 2016.









/s/ Kathryn Joy Strickland
Document ID No: 20154017890-170981

Notary Public








ID No. 20154017890

My Commission Expires: May 8, 2019

COUNTY OF MARICOPA
STATE OF ARIZONA

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