A Perspective on CBDCharlton Owensby, MD, JD, MBA, FCLM, MRO

Certified Medical Review Officer

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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

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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

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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

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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

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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

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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

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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

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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.

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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

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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.

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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)

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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

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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

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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

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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.

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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

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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

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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

The Internet – a Cautionary Word

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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.

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Contact Information

Charlton Owensby, MD, MRO

(800) 381-4718 (voice and fax)

mro@mrosvcs.com

Or you may contact me through your TPA

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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)

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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)

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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)

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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)

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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)

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Slide 12 – So what’s the problem? DOT and THC/Marijuana/CBD (DOT Medical Marijuana Notice, updated

4/29/2019)

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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)

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

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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

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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)

Retail Product to legal High?

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