A Perspective on CBD Charlton Owensby, MD, JD, MBA, FCLM, MRO - PowerPoint PPT Presentation

A Perspective on CBD Charlton Owensby, MD, JD, MBA, FCLM, MRO Certified Medical Review Officer 1

Introduction  Practicing physician and attorney  B.S., M.D., J.D., MBA all from Wake Forest  Certified and active MRO since 1991  Responsible for 120,000+ drug evaluations/year  All across the U.S., abroad and the Seven Seas  Serve as MRO for several large TPAs and companies 2

Disclosure  Not your attorney or doctor (probably your MRO)  No conflicts, no quid pro quo for any opinions  These are my opinions from experience and research 3

I Was Asked to Address These:  What is CBD?  What does it do?  Where does it come from?  Why is it such a big deal suddenly?  Is it legal?  What happens when I take it?  Why would I get a positive drug screen if I take it?  Are you kidding? How can I get a positive drug screen if this is legal and doesn’t have THC in it???  Consequences (employment) of using CBD 4

Take Away  The only reason we are talking about CBD is because of its association with marijuana  CBD is pretty innocuous, doesn’t harm, but doesn’t do much either  CBD is not THC and will not reasonably cause a positive test for THC/marijuana  Remember your drug testing policy 5

Some Marijuana Background  Marijuana vs. Hemp  California. Don’t all these things start there?  California Prop 215, 420. Farm Bill of 2018  Is Marijuana a medicine?  1 in 12 of you used it in the last month 6

More About Hemp  What’s up with Hemp? The 0.3% delineation  Can hemp products be sold? Can they be purchased?  Can hemp products be marketed as a medicine?  There are no industry standards for purity or content 7

Now on to CBD  The hemp product du jour: CBD  Cannibidiol, one of many cannabinoids  2-[(1R,6R)-3-Methyl-6-prop-1-en-2-ylcyclohex-2-en-1-yl]- 5-pentylbenzene-1,3-diol. This is why we call it CBD  Characteristics – physical, sources, how sold, how used  CBD is not THC. These are different compounds  Why the attention to CBD? Association with marijuana  Marijuana normalization, the Internet and social media 8

What Does CBD Do?  Not much.  One FDA approved medical use  As an adjunct to conventional medications for rare childhood seizure disorders  Despite 6000+ published studies, seems to have limited usefulness thus far as a medication  On the other hand, does not seem to harm either. 9

What Doesn’t CBD Do?  Note the title can be interpreted two ways  Internet sources say it seems to help/cure everything  Scientific research shows it doesn’t do much of anything  Though of course this can change with more research 10

CBD Oil Review  Typical CBD doses (as recommended by COR):  Appetite stimulation in Cancer patients: 1 mg CBD daily x 6 weeks  Chronic pain: 2.5 to 20 mg daily  Epilepsy: 200-300 mg daily (compare to Epidiolex dosage)  Huntington’s chorea: 10mg/kg daily x 6 weeks  Sleep disorders: 40-160mg daily (should that be nightly?)  Schizophrenia: 40-1280mg daily. I’d suggest a whole lot more….  Glaucoma: 20-40 mg SL once only  A couple of these should frighten you. 11

So What’s the Problem?  Employment drug testing  More specifically, the THC positive drug test  Can CBD reasonably explain a positive THC result?  Not for Federal testing programs. Period.  My experience (not as a user, as an MRO) 12

Three Potential ‘Explanations’  CBD itself caused a (false) positive THC result  The 0.3% THC in CBD caused the positive THC result  CBD conversion to THC caused the positive THC result 13

CBD is not THC  CBD is 2-[(1R,6R)-3-methyl-6-prop-1-en-2- ylcyclohex-2-en-1-yl]-5-pentylbenzene-1,3-diol  THC is 6,6,9-trimethyl-3-pentyl-6a,7,8,10a- tetrahydrobenzo[c]chromen-1-ol  Now that that’s cleared up…  Bottom line: Current testing methodology is not fooled 14

What About That 0.3% THC?  First of all, if legal, it is likely less than 0.3% THC  But note lack of standards or purity for CBD products  Cost to obtain a positive drug screen by consuming CBD  Using common CBD products as compared to one joint  Compared to likely minimum to cause positive result  Side effects along the way 15

Can I Make My Own THC?  A research ‘food fight’ at the Journal of Cannabis Research  CBD in an acid environment can oxidize to THC  The stomach is an acid environment, ergo  My THC positive drug test is because I consumed CBD. QED.  Nope. 16

The Journal Fight  2016 Article states CBD oxidized to THC, in-vitro in SGF  Rebuttal claims otherwise:  Simulated Gastric Fluid not same as in-vivo actual gastric fluid  Effect has not been observed in-vivo  Drug testing after large doses of CBD not positive for THC  Research continues, but no evidence for significant in- vivo 17

Besides all that…  No possible gastric conversion if not in stomach  Implications for topical or inhaled CBD  Almost all oral CBD products are intended trans- mucosal  Normal dosing of 1-2 ml quickly absorbed in mouth  Little gets to stomach  Swallowing 1-2 ounces of CBD is not really reasonable 18

The Internet – a Cautionary Word  This is where all employees obtain their information.  A true informational swamp.  Advocacy colors research, evaluation and conclusions – especially with emotionally charged topics – use with caution.  Anecdotes (even a lot of them) ≠ data  Lings Cars, a metaphor for all that is wrong 19

The Takeaway  Despite all the claims, CBD is not a wonder drug, but it is likely not particularly harmful either  CBD is not THC/marijuana and cannot cause a positive drug test result for THC  CBD products currently being sold are likely to contain varying amounts of CBD from none to 30%. No industry quality control or standardization. May also contain more THC than is allowed to be marketed.  Your policy may need to address CBD as unacceptable to explain a positive THC result. 20

Contact Information  Charlton Owensby, MD, MRO  (800) 381-4718 (voice and fax)  mro@mrosvcs.com  Or you may contact me through your TPA 21

 Slide 6 – Some Marijuana Background  California Proposition 215 (1997)  California Proposition 420 (2003)  Origins of 420 Association with Marijuana (from LAWeekly 2013)  Hemp and Cannabidiol: What is a Medicine? (Missouri Medical Society – good overview, despite math error)  Marijuana Use Incidence SAMHSA Annual Survey 2017  Marijuana Use Incidence Quest Diagnostics Annual Index (employment testing results) 22

 Slide 7 – More about Hemp  Differentiating marijuana and hemp (From NCSU)  Differentiating marijuana from hemp (from the Ministry of Hemp)  Defining Hemp: A Fact Sheet (Congressional Research Service) 23

 Slide 8 – Now on to CBD  CBD Compound Summary (PubChem, US National Library of Medicine)  THC Compound Summary (PubChem, US National Library of Medicine)  Can CBD be Sold? (FDA Regulation of Cannabis Derived Products 2019, good resource)  The Truth about CBD, What’s Real and What’s Hype (From the Fresh Toast ‘the most trusted name in cannabis’ website)  Typical Products  YumYum Gummies, CBD Oil Drops (Diamond CBD products)  Oils, Pills (Pure KANA products)  CBD Gel Capsules (MEDTerra products) 24

 Slide 9 – What does CBD do?  Epidiolex (FDA aproved use in Dravet’s/Lennox-Gastaut)  Review of Clinical Trials for Epidolex (Pharmacy presentation UT Austin)  PubMed Studies (NCBI PubMed 6400 articles/studies as of May 2019) 25

 Slide 10 – What Doesn’t CBD do?  CBD – What we know and what we don’t (Harvard Health Blog, Peter Grinspoon, MD 8/24/2018) 26

 Slide 12 – So what’s the problem?  DOT and THC/Marijuana/CBD (DOT Medical Marijuana Notice, updated 4/29/2019) 27

 Slide 13 – Three potential Explanations  Can CBD Oil cause a Positive Drug Test? (Forbes “Marijuana Madness: This is How CBD Oil can cause a failed drug test”, 10/18/18)  Failed a Drug Test after CBD? Here’s Why (Marijuana Break website, some incorrect information, and poor proofreading, but the gist is there) 28

 Slide 17 – The Journal Fight  Yes you can (Cannabis Cannabinoid Research)  No you can’t (Cannabis Cannabinoid Research) 29

A Typical CBD Product: Premium Jane  Assumptions:  1 Marijuana joint will contain 60-120 mg THC  THC is 30% absorbed from lung tissue  THC delivered dose is 20-40 mg THC  Premium Jane product contains 1000mg CBD/oz  40 doses per 1 ounce bottle, 25 mg CBD/dose  Does not contain >.2% THC  THC is 30% absorbed by oral mucosa 30

Retail Product to legal High?  Premium Jane dose to produce same effect as 1 joint  THC per Premium Jane dose:  (25 mg dose)(30%)(.2% THC) = 0.015 mg THC/dose  20 mg THC/0. 015 mg THC/dose = 1,333 Premium Jane doses  1,333 doses/40 doses per bottle = 33 bottles (ounces)  33 oz/32 oz per quart = ~1 quart Premium Jane  Cost: 33 bottles x $139/bottle = $4,628 (shipping extra) 31