Drug Policy Project of Utah Offers Amendments to Senate Bill 89

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On Monday March 7th, 2016 at 7:30am the Utah House of Representatives Health and Human Services Committee will debate and vote on Senate Bills 73 and 89. There has been talk of combining the bills to create a compromise that can pass the Utah House of Representatives before the legislative session ends on Thursday March 10th, 2016. 

Today the Drug Policy Project of Utah sent a letter with specific recommendations for how to merge the two proposals. We laid out a very specific vision for how to create a compromise that works for all stakeholders - patients, physicians, law enforcement, and others. Our five recommendations would pave the way for a medical cannabis program that will work, that can be expanded upon later, and that would mark the first step of our journey toward a medical cannabis program that is rooted in our 10 Key Values.

Below are our recommendations, read the original letter here.

March 3, 2016

To:

Honorable Members of the Utah House of Representatives Health and Human Services Committee

From:

Drug Policy Project of Utah -Board of Trustees

Dear Representative,

The Drug Policy Project of Utah (DPPU) would like to thank you for this opportunity to comment on Senate Bills 89 and 73, which will be heard by your committee.

DPPU is Utah’s largest membership-based drug reform advocacy organization. As an IRS recognized 501c3 nonprofit organization we are dedicated to providing research and public policy analysis to all Utahns about drug policies and the effect of they have on our communities, families, and individuals.  Along with other medical cannabis advocates, DPPU is in support of creating a medical cannabis program here in Utah, and we applaud the incredible amount of time and energy that Senators Madsen and Vickers have exhausted on crafting the two medical cannabis proposals before you. DPPU has organized press and public events, prepared research documents that compile and analyze gold standard, peer-reviewed studies on many of the conditions being considered for inclusion in these pieces of legislation, and consistently provided accurate, up-to-date information to Utahns who are interested in the proceedings surrounding Senate Bills 73 and 89.

We understand and commend the desire to reconcile the different approaches of these two pieces of legislation and have compiled the following suggestions for deliberation as you move forward with the difficult task of creating an appropriate and robust medical cannabis program in Utah. We submit for your consideration the following requests that we believe will positively pave the way for Utah to establish a comprehensive medical cannabis program based on scientific research, national best practices, and compassion. 

1. Adjusting the allowable ratio of CBD : THC

The first evidence that cannabidiol (CBD), a non-psychoactive component of the cannabis plant, could have antipsychotic properties was published in 19821. This initial study investigated the interaction between THC and CBD in health volunteers. The study’s authors co-administrated the two cannabinoids together and found that when done in closer to equal ratios study participants experienced less anxiety and paranoia than with THC alone1. The possible antipsychotic effect of CBD received further support with a report of a higher frequency of acute psychotic episodes in patients admitted in psychiatric hospital after the use of a variety of cannabis strains virtually devoid of CBD2. These initial results led to a series of studies that have established, from laboratory bench to patients, a clear link between CBD and its’ antipsychotic activity.

Research on the benefits of THC and CBD in isolation is becoming more and more established. With THC demonstrating analgesic, anti-emetic, and anti-inflammatory properties, and CBD possessing anti-psychotic, anti-seizure, and anti-anxiety properties3-4. Research on the simultaneous use of a 1:1 ratio of THC to CBD is still in its infancy, but what is believed to be one of the first studies on this topic can be traced to Brazil in the mid-1970s. In this study, patients were given between 15-60mg of CBD in conjunction with 30mg of THC, and the resulting effects were measured5. Subjects reported a more pleasurable experience and less anxiety with the combination of CBD and THC than they felt with THC alone5. Furthermore, a different group of scientists examined the effects of administering CBD at a dose six times that of THC6. They found that 73% of study participants reported a decreased feeling of being “high” when compared to THC alone6. Follow-up studies have demonstrated that the combination of the two cannabinoids reduced users’ experiences of increased heart rate, gait instability, and difficulty in eye tracking exercises7. These results, plus many others currently in the literature, support the idea that CBD works to minimize some of the anxiety-inducing side effects of THC. And in combination, they exert positive therapeutic benefits to patients. 

2. Inclusion of PTSD unrelated to military service

We are also particularly concerned about SB73’s exclusion of unqualified Post-traumatic Stress Disorder (PTSD) as a qualifying condition. Many Utahns including law enforcement officers, firefighters, emergency responders, and victims of sexual assault or other traumatizing experiences will be excluded.

PTSD is a DSM-5 anxiety condition in which a prior intense trauma results in a long-lasting anxious response, with re-experiencing or flashback phenomena, avoidance of triggers and overall emotional numbing being the hallmark characteristics of this condition8. There has been a recent emergence of empirical studies on the effects of cannabis on the most common symptoms of PTSD, borne primarily out of the observation that individuals with PTSD report using cannabis to assist in coping with the difficult symptoms associated with this condition; specifically, hyperarousal, negative affect and sleep disturbances9-10. Much of the empirical work on this topic has consistently demonstrated that the endocannabinoid system plays a significant role in the etiology of PTSD, by way of increased total number of receptors in the brains of those suffering from this condition when compared to healthy control subjects11-12. So, in effect, PTSD brains contain more cannabinoid receptors than non-PTSD brains, leading researchers to postulate that these patients do respond differently to cannabis when compared to patients not suffering from PTSD.

Multiple studies suggest that THC and CBD may actually exert opposite actions on brain function with several lines of preclinical work having shown that CBD reduces the effects of THC on several different behavioral function tests13-15. In line with this data, CBD has been found to reduce anxiety and improve overall sensations of wellbeing when combined with acute, high doses of THC in healthy volunteers16. More recent studies have demonstrated that CBD actually reduces anxiety in patients affected by social phobia17. In this vein, CBD has been shown to elicit anti-panic effects through activation of important brain receptors critical in modulating our emotional reactivity to stress18. It is with this data, and much more not presented here, that leading experts are now beginning to realize that patients suffering from PTSD and other anxiety related mental health conditions may, in fact, benefit from more CBD-rich strains of cannabis, but not CBD in isolation.

3. Improving the qualifying conditions list

Both Senate Bill 73 and 89 use a qualifying conditions list to delineate which medical conditions the program will cover. We recommend the conditions lists from both proposals be merged so that a broader range of patients may be included in the initial program. Medical research supports the list of conditions included in both bills and SB73’s list is supported by the findings of a significant body of evidence regarding the efficacy of medical cannabis in the treatment of patients. 

We recommend the following language:

Qualifying illness.

(1) For the purposes of this chapter, the following conditions are considered a

qualifying illness:

(a) HIV, acquired immune deficiency syndrome or an autoimmune disorder;

(b) Alzheimer's disease;

(c) amyotrophic lateral sclerosis;

(d) cancer, cachexia, or such condition manifest by physical wasting, nausea, or

malnutrition associated with chronic disease;

(e) Crohn's disease or a similar gastrointestinal disorder;

(f) epilepsy or a similar condition that causes debilitating seizures;

(g) multiple sclerosis or a similar condition that causes persistent and debilitating

muscle spasms;

(h) post-traumatic stress disorder; and

(i) chronic pain in an individual

On or before September 30 of each year, the committee shall:

(a) review the list of conditions described in Subsection (1) to determine if, based on available medically relevant information, it is medically appropriate to add a condition to the list; and

(b) present the committee's recommendation to the Health and Human Services Interim Committee.

 

4. Improving the process for adding new conditions

Both SB73 and SB89 offer a pathway to adding new medical conditions to the original list through either the Controlled Substance Advisory Committee (SB89) or the Compassionate Use Board (SB73.)

We are concerned the Controlled Substance Advisory Committee is heavily reflective of regulatory agencies and not the medical community. We recommend that language from SB73 and SB89 be combined to create a hybrid system for creating a pathway for patients and their doctors to add disease states that would then be included in the program. We believe that the Compassionate Use Board in SB73 should be included in the final version of both pieces of legislation and should either; a) make a recommendation directly to the legislature, or b) make an initial recommendation to CSAC which will then make a final recommendation to the legislature. Both pathways are agreeable to us and we believe this more balance by ensuring the program is neither overly restrictive nor permissive. 

We recommend the following language for the Compassionate Use Board:

“Compassionate Use Board.

(1) The department shall establish a Compassionate Use Board consisting of:

(a) five physicians who currently licensed and practicing in the state and

certified in one of the following specialties:

 (i) neurology;

(ii) pain medicine and pain management;

(iii) medical oncology;

(iv) psychiatry;

(v) infectious disease;

(vi) internal medicine; and

(vii) pediatrics;{ and}

(b) the director of the Department of Health or the director's ;

and

(c) two medical research professionals with expertise in cannabinoids or a qualifying

illness, including one medical research professional who is affiliated with a research-based higher education institution.

(2) The department shall appoint at least one member of the board who has a specialty in addiction medicine.

5. Inclusion of affirmative defense

Emerging legal precedent including a recent Arizona Supreme Court19 ruling that found that the presence of cannabis metabolites, which can remain in the bloodstream for 30 days, cannot be used as valid evidence of impairment, supports SB73’s inclusion of language allowing for an affirmative defense. The incorporation of this type of defense does not condone the illicit use of cannabis as the current statute allows for those who are impaired to be charged.

We recommend using this following language from SB73:

(3) It is an affirmative defense to prosecution under this section that the controlled substance was:

(a) involuntarily ingested by the accused;

(b) prescribed by a practitioner for use by the accused; [or]

(c) a cannabis product that was:

(i) not causing impairment; and

(ii)

(A) recommended by a physician to the accused, if the accused holds a valid

medical cannabis card under {this section}; or

(B) ingested by the accused in another state in which the use of {cannabis or} a

cannabis product is legal under state law; or

[(c)] (d) otherwise legally ingested.

In closing we want to express our sincere appreciation for your consideration of this complex issue. We appreciate the hard work that each of are engaged in.

 

References:

1. Zuardi AW, Shirakawa I, Finkelfarb E, Karniol IG. Action of cannabidiol on the anxiety and other effects produced by delta 9-THC in normal subjects. Psychopharmacology (Berl) 1982; 76: 245-50.

2. Rottanburg D, Robins AH, Ben-Aire O, Teggin A, Elk R. Cannabis associated psychosis with hypomaniac feature. Lancet 1982; 2:1364-6.

3. Pertwee, RG. Cannabinoid receptors and pain. Progress in Neurobiology. 2001; 63(5): 569-611.

4. Zuardi AW, Crippa JA, Hallak JE, Bhattacharyya S, Atakan Z, Martin-Santos R, McGuire PK, Guimarães FS. A critical review of the antipsychotic effects of cannabidiol: 30 years of a translational investigation. Current Pharmaceutical Design. 2012; 18(32): 5131-40.

5. Karniol IG, Shirakawa I, Kasinski N, Pfeferman A, Carlini EA. Cannabidiol interferes with the effects of delta 9 - tetrahydrocannabinol in man. European Journal of Pharmacology. 1974; 28(1): 172-7.

6. Dalton WS, Martz R, Lemberger L, Rodda BE, Forney RB. Influence of cannabidiol on delta-9-tetrahydrocannabinol effects. Clinical Pharamcology and Theraputics.1976; 19(3): 300-9.

7. Roser P, Vollenweider FX, Kawohl W. Potential antipsychotic properties of central cannabinoid (CB1) receptor antagonists. World J Biol Psychiatry. 2010; 11(2 Pt 2): 208-19.

8. American Psychiatric Association. (2013). Diagnostic and statistical manual of mental disorders: DSM-5. Washington, D.C: American Psychiatric Association.

9. Bonn-Miller MO, Vujanovic AA, Feldner MT, Bernstein A, Zvolensky MJ. Posttraumatic stress symptom severity predicts marijuana use coping motives among traumatic event-exposed marijuana users. J Trauma Stress. 2007; 20:577–86.

10. Vandrey R, Babson KA, Herrmann ES, Bonn-Miller MO. Interactions between disordered sleep, post-traumatic stress disorder, and substance use disorders. Int Rev Psychiatry. 2014; 26:237–47.

11. Neumeister A, Normandin MD, Pietrzak RH, Piomelli D, Zheng MQ, Gujarro-Anton A, et al. Elevated brain cannabinoid CB1 receptor availability in post-traumatic stress disorder: a positron emission tomography study. Mol Psychiatry. 2013; 18:1034–40.

12. Passie T, Emrich HM, Karst M, Brandt SD, Halpern JH. Mitigation of post-traumatic stress symptoms by cannabis resin: a review of the clinical and neurobiological evidence. Drug Test Analysis. 2012; 4:649–59.

13. Bhattacharyya S, Morrison PD, Fusar-Poli P, Martin-Santos R, Borgwardt S, Winton-Brown T, et al. Opposite effects of delta-9-tetrahydrocannabinol and cannabidiol on human brain function and psychopathology. Neuropsychopharmacology: official publication of the American College of Neuropsychopharmacology. 2010; 35(3):764–74.

14. Vann RE, Gamage TF, Warner JA, Marshall EM, Taylor NL, Martin BR, et al. Divergent effects of cannabidiol on the discriminative stimulus and place conditioning effects of Delta(9)-tetrahydrocannabinol. Drug and alcohol dependence. 2008; 94(1-3):191–8.

15. Malone DT, Jongejan D, Taylor DA. Cannabidiol reverses the reduction in social interaction produced by low dose Delta(9)-tetrahydrocannabinol in rats. Pharmacology, biochemistry, and behavior. 2009; 93(2):91–6.

16. de Paula Soares V, Campos AC, Bortoli VC, Zangrossi H, Jr., Guimaraes FS, Zuardi AW. Intra-dorsal periaqueductal gray administration of cannabidiol blocks panic-like response by activating 5-HT1A receptors. Behavioural brain research. 2010;213(2):225–9. 

17. Zuardi AW, Shirakawa I, Finkelfarb E, Karniol IG. Action of cannabidiol on the anxiety and other effects produced by delta 9-THC in normal subjects. Psychopharmacology. 1982; 76(3):245–50.

18. Crippa JA, Derenusson GN, Ferrari TB, Wichert-Ana L, Duran FL, Martin-Santos R, et al. Neural basis of anxiolytic effects of cannabidiol (CBD) in generalized social anxiety disorder: a preliminary report. J Psychopharmacol. 2011; 25(1):121–30. 

19. Arizona Supreme Court Ruling. Accessed here:

http://archive.azcentral.com/ic/pdf/arizona-court-marijuana-ruling.pdf