“Experience without memory is useless.” —Martha Gellhorn O’Shaughnessy’s $795 The Journal of Cannabis in Clinical Practice BeyondTHC.com Winter 2015/16 Benefit too obvious to deny: U.S. weighs rescheduling a molecule as CBD-rich cannabis proves helpful to children with epilepsy and others By Fred Gardner Diverse Sources of Cannabidiol In August 2013, the widely respected neurosurgeon Sanjay Gupta, MD, docu- mented on television the dramatic seizure relief that CBD-dominant cannabis oil was affording a little girl with Dravet Syn- drome, a very severe form of epilepsy. Her name was Charlotte Figi. In the two years that followed, reports from physicians treating pediatric epilepsy patients in various contexts —including “expanded access” programs authorized by the U.S. Food and Drug Administration— have confirmed that CBD is an effective anti-convulsant. Bonni Goldstein, MD, in California and Margaret Gedde, MD, in Colorado have each monitored the progress of hundreds of Sanjay Gupta, MD, interviewed Geoffrey Guy, MD, at a facility in “Mom-and-pop growers” in Nevada County, California, organized a pediatric epilepsy patients. (See stories on England where Guy’s GW Pharmaceuticals grows CBD-rich Canna- plant giveaway featuring CBD strains ACDC, Harlequin, Medi-Haze bis plants and makes extracts for medical use. Epidiolex, a GW ex- and Cannatonic. Oil made from CBD-rich plants is distributed by dis- pages 7 and 33.) More than 600 patients tract that is 99% CBD, is being given to children with severe epilepsy pensaries that are legal under state law. Physicians are monitoring the have been treated in FDA-sanctioned pro- at research centers in the U.S. Graphic: CNN progress of pediatric epilepsy patients using CBD-rich oil. grams using GW Pharmaceuticals’ Epidio- lex, a plant extract that is 99% CBD. Cannabis oil is made by treating har- Few patients who use cannabis in treat- take close to an hour to come on, but can Slightly more than half the children us- vested plants with a solvent that extracts ing epilepsy smoke or inhale vapor from last eight or nine hours. ing CBD-rich oil are having significantly beneficial compounds and leaves behind CBD-rich flowers, although some report CBD counters the mood-altering effects fewer and less-severe seizures. Personali- the cellulose. Like Charlotte Figi, many that inhalation after a seizure can reduce of THC, but as a component of the Canna- ties and abilities emerge as children wean people who use CBD need large, sustained the duration of a headache. bis plant, it is defined by the U.S. govern- off debilitating synthetic anti-convulsants. doses to deal with serious illness. The most Inhaled cannabis goes through the lungs ment as harmful and without medical use, The side effects of CBD are generally efficient delivery vehicle is a cannabis ex- to the brain and exerts its effects almost and it remains on Schedule I of the federal mild; drowsiness is foremost. tract —for example, 50 milligrams of CBD immediately, but the effects tend to wear Controlled Substances Act. There is an ob- in a milliliter of olive or coconut oil— in off within an hour. Ingested orally, the vious gap between federal law and reality. Why CBD-rich oil works for droppers or tubes. Cannabis oil can be di- compounds in cannabis pass through the It can be fully closed by rescheduling or some patients but not for others luted to facilitate measured dosing. stomach and the liver on the way to the descheduling the plant, and partially closed Lower doses of CBD can be delivered in brain. They get metabolized into slightly by singling out cannabidiol for deschedul- is being pursued by researchers. sprays for under-the-tongue application. different compounds whose effects may ing. continued on page 30 For a fortunate five to 10 percent of pa- For a slimmer waistline? tients, CBD-rich oil eliminates seizures en- tirely. For an approximately equal number, THCV plants being grown for medical use in California; it doesn’t help at all, or exacerbates symp- toms. Cannabinoid may counter metabolic-syndrome symptoms Why CBD-rich oil works for some pa- By O’S News Service tients but not for others is being pursued Cannabis varieties containing unusually THCV blocked anandamide (the molecule blocking the CB1 receptor— as a treatment by researchers. In most pediatric epilepsy high amounts of THCV —tetrahydrocan- made by our bodies that activates the CB1 for metabolic syndrome. The first-ever cases the conditions are caused by genetic nabivarin—will become available to medi- receptor) while allowing THC to act almost mention of the endocannabinoid system in mutations. Some but not all gene-based cal users in 2016, thanks to kind fate and unimpeded at CB1. John McPartland com- the Journal of the American Medical As- epilepsies are amenable to treatment with propagators who chose not to hoard their mented on Pertwee’s finding: “It’s as if sociation was a paper entitled “Effect of CBD, and some are proving amenable to unusual bounty. cannabis was designed as a combination Rimonabant, a Cannabinoid-1 Receptor treatment with CBD plus THC and other The difference between THCV and THC remedy that simultaneously gave our en- Blocker, on Weight and Cardiometabolic cannabinoids. is slight at the molecular level (two fewer dogenous mechanism a rest (shutting down Risk Factors in Overweight or Obese Pa- Doctors and patients are tracking which carbon atoms in the “tail” —see illustra- anandamide), and supplemented with an tients: RIO-North America: A Randomized cannabinoid-terpenoid blends are most ef- tion on page 21), but susbtantial in terms exogenous remedy (THC).” Controlled Trial,” published in February fective in treating various conditions. of how they work and their impact on the Also in 2005 the pharmaceutical giant 2006 —about 14 years after the compo- body. Sanofi-Aventis had begun marketing a drug nents of the system had been identified. GW Pharmaceuticals began investigat- called Rimonabant —which works by fully continued on page 50 ing THCV more than a decade ago in hopes that it could be useful in treating metabolic syndrome. The dis- order is actually a set of symptoms —high blood pressure, in- creased abdominal fat, elevated blood sugar, and unhealthy choles- terol levels— that are Paige Figi’s daughter Charlotte experi- associated with obesi- enced dramatic seizure reduction after being ty, type II diabetes and given CBD-rich cannabis. Fifteen states have heart disease. adopted bills legalizing CBD for medical use. Figi is lobbying Congress in support of a bill Roger Pertwee and that would remove CBD from Schedule I, the colleagues at the Uni- category for dangerous drugs with no known versity of Aberdeen ‘Black Beauty’ plants high in thcv were grown in western Marin County, California, in the summer of 2015. medical use. reported in 2005 that Elevated pots enable “wicking” of water (with fertilizer). —30—O’Shaughnessy’s • Winter 2015/16

CBDevelopments from page 1 The Road to FDA Approval —the George H.W. Bush era— as AIDS Epidiolex enabled 48% to In 1998 GW Pharmaceuticals received patients began applying en masse, thanks approval from the British Home Office to to the organizing efforts of Robert and Al- achieve at least a 50% reduction develop medicines from Cannabis plant ice O’Leary Randall. The IND program in seizure frequency compared to extracts featuring cannabinoids other than existed in bureaucratic limbo until 1997, baseline. THC and delivered by means other than when Congress passed the Food and Drug smoking. In numerous lab studies CBD Administration Modernization Act. mum amount of time determined to offer The FDA then developed regulations accurate effectiveness measure). Epidiolex has been shown to exert various benefi- worse 0-24% 25-49% 50-74% 75-100% cial effects, and GW has been developing covering IND studies for unapproved had enabled 48% to achieve at least a 50% medicines designed to treat a wide range drugs. These were revised over the years, reduction in seizure frequency compared Levels of improvement experienced by of illnesses. and in August 2009 FDA issued its “final to baseline. first 27 patients in Epidiolex IND. Bars GW’s flagship product Sativex —which rule” on “Expanded Access to Investiga- Over the course of 2014, physicians show percentage of patients achieving contains an equal mix of CBD and THC— tional Drugs for Treatment Use.” The sum- would conduct Treatment-Resistant Epi- various levels of seizure reduction. Four was the first plant-derived cannabinoid mary states: lepsy INDs at The Children’s Hospital of patients (15% were deemed to have got- medicine to win approval from regula- “Expanded access to investigational Philadelphia, Lurie Children’s Hospital in ten worse.) tory authorities. An extract formulated for drugs for treatment use is available to in- Miami, Pediatric and Adolescent Neurode- spraying under the tongue, it has been ap- dividual patients, including emergencies; velopmental Associates in Atlanta, Texas Assuming the doctors find a statistically proved in 27 countries (starting with Cana- intermediate-size patient populations; and Children’s Hospital, MassGeneral Hospital significant reduction in seizure frequen- da in 2005) for treating pain and spasticity larger populations under a treatment pro- for Children, the University of Utah Medi- cy—and an unthreatening adverse event in Multiple Sclerosis. tocol or treatment investigational new cal Center, Wake Forest School of Medi- profile— GW would submit the data to In recent years GW has been testing vari- drug application (IND). The final rule is cine, and Nationwide Children’s Hospital FDA. A priority review would take eight ous formulations and providing CBD to intended to improve access to investiga- in Columbus, Ohio. months, and if all goes well, Epidiolex scientists conducting preclinical studies in tional drugs for patients with serious or im- Thanks to organizing efforts led by Paige could become the first FDA-approved animals. GW supplied Ben Whalley and mediately life-threatening diseases or con- Figi, a dozen states enacted laws in 2014 medication for Dravet and LGS syndromes colleagues at the Center for Integrative ditions who lack other therapeutic options that legalized the medical use of CBD; after the middle of 2017. Neuroscience and Neurodynamics, Uni- and who may benefit from such therapies.” some even provided money for research. If approved by FDA, CBD will automati- versity of Reading, who used mouse mod- The FDA regulations spell out criteria By 2015 health departments in four states cally be rescheduled. The schedule will els of epilepsy to establish safety and show for INDs. The would-be investigator must ­—Georgia, New York, Alabama, and Flor- depend on a body of preclinical and clini- that CBD and another cannabinoid, CBDV, submit, among other things: “Chemistry, ida— were funding INDs, picking up the cal (human) data that indicate whether the exert anti-seizure and anti-inflammatory manufacturing, and controls information tab for physician visits, lab tests, data col- substance has abuse liability. It is likely effects. This research came to the attention adequate to ensure proper identification, lection, and Epidiolex (which GW donated that the Schedule will be somewhere be- of families in the U.S. who had loved ones quality, purity, and strength of the investi- to hospital-funded INDs). More than 200 tween III and V, since CBD does not seem with epilepsy. gational drug.” patients would soon be enrolled in state- to have the abuse potential of products like In other words, FDA wants to see a sponsored INDs. opioids, which are generally schedule II. Insurance companies are expected to re- In late 2012 some American highly standardized, tested, “Good-Man- ufacturing-Practices” medication —which Efficacy documented imburse for an FDA-approved Epidiolex. parents contacted GW in hopes Epidiolex is. NIDA is still providing Mis- In April, 2015, at a meeting of the Ameri- The level of reimbursement will be worked of obtaining CBD. sissippi-grown cannabis cigarettes to four can Academy of Neurology, Devinsky was out between GW and the payors. surviving beneficiaries of the old, informal lead author on a poster presenting efficacy “Expanded Access” IND program. Those cigarettes would not data on 137 patients who had completed 12 A drug that is beneficial in treat- Physicians, patients, and parents know be approved as a treatment under the cur- weeks of treatment with Epidiolex. There ing the most severe forms of epi- that currently used anti-epilepsy drugs rent FDA regulations. were 25 Dravet Syndrome and 22 Lennox- lepsy is likely to be beneficial in (AEDs) are detrimental to cognition and The FDA requires “Pharmacology and Gastaut Syndrome (LGS) patients among longterm development. CBD is way, way toxicology information adequate to con- them, and patients with 10 other rare and treating most seizure disorders. milder than conventional anti-convulsants clude that the drug is reasonably safe at the severe types of epilepsy, some involving The company also plans a clinical trial in terms of side effects. dose and duration proposed for the treat- congenital abnormalities. of Epidiolex in other pediatric epilepsies, In late 2012 some American parents con- ment use.” “Overall seizure frequency was reduced starting with Tuberous Sclerosis Complex tacted GW in hopes of obtaining CBD. When GW was approached by the par- by 54% in all patients and by 63% in Dra- (TSC), a genetic disorder that causes non- They asked if the company could provide ents of epilepsy patients in late 2012, the vet Syndrome patients,” Devinsky et al malignant tumors in the brain and other CBD to the physicians treating their chil- company already possessed extensive reported. Nine percent of all patients and organs, and affects some 50,000 patients dren under the Food and Drug Administra- preclinical data —five-and-a-half years’ 16% of Dravet patients were seizure-free in the US. Approximately 60% of TSC tion’s “Expanded Access” IND program. worth— establishing the safety of its CBD after 12 weeks. Those patients who were patients have treatment-resistant seizures. GW, which had been working closely product, as well as information the FDA on Epidiolex for 24 weeks showed no fall- All five such patients in the expanded ac- with the FDA in connection with Sativex, would require concerning its chemistry, off in effectiveness. cess program were helped by Epidiolex, it looked into the IND option and decided the manufacturing, controls, pharmacology, “Randomized controlled trials are war- was reported at the American Epilepsy So- expanded access regulations might indeed and toxicology. ranted,” the researchers concluded, “and ciety’s annual meeting in December 2014. allow the company to provide Epidiolex to In December 2012 GW agreed to provide we are pleased to report that these are now Another condition for which CBD has the parents, even though it was an investi- purified CBD and the requisite data for sin- ongoing.” proved beneficial in animal studies —and gational medicine. gle-patient INDs conducted by epileptolo- In the spring of 2015 GW commenced for which Epidiolex has been given or- Back in 1978 —the Jimmy Carter era— gists Roberta Cilio, MD at UC San Fran- two placebo-controlled clinical programs, phan drug status— is Neonatal Hypoxic- the FDA had established a so-called “com- cisco, and Orrin Devinsky, MD at NYU one in Dravet syndrome and one in Len- Ischemic Encephatopathy, or NHIE (brain passionate IND program” through which a School of Medicine nox-Gastaut syndrome (LGS). Both of damage caused by oxygen deprivation dur- few patients received marijuana grown at In October 2013 GW supported and these “pivotal” trials are designed to sup- ing delivery). the University of Mississippi for the Na- NYU sponsored a meeting in New York of port a New Drug Application with the FDA “In neonatal hypoxic-ischemia,” says tional Institute on Drug Abuse. The pro- epilepsy specialists interested in conduct- by mid-2016. GW chairman Geoffrey Guy, MD, “you’ve gram was closed to new patients in 1990 ing clinical research with purified CBD in Conditions such as Dravet Syndrome got an underlying inflammatory process the United States. Devinsky described dra- and Lennox-Gastaut Syndrome that affect which is massively exaggerated by excito- matic benefit provided to his initial patient a very small subset of the population —un- toxicity after each seizure, which is setting by CBD treatment, and his plans to conduct der 200,000 in the U.S.—are designated up the next seizure in a way. It’s not enough an IND treatment program at NYU. Many “orphan diseases,” and treatments devel- to treat just the seizures without treating of the doctors at the conference asked to oped for them are referred to as “orphan the underlying inflammatory encephalitis sponsor INDs at their institutions. GW drugs.” Most orphan diseases are the result and the damage to neuroplasticity. agreed to provide them with Epidiolex. of genetic mutations. “Children’s brains are very plastic and By January, 2014, INDs conducted by The Orphan Drug Act of 1983 conferred can usually work around issues, but if Devinsky at NYU (60 patients) and Rober- tax breaks and market exclusivity protec- you’re having continuing seizures and ta Cilio at UCSF (25 patients) were under- tions on pharmaceutical companies willing continuing inflammation, that ability will way. The patients were children and young to develop drugs for which the market is be dampened. We’re hoping from the pre- adults with various forms of Treatment Re- minuscule. clinical work that cannabidiol will address sistant Epilepsy. Each patient’s frequency GW Pharmaceuticals sought and was a number of these different issues, not just of seizures had been determined by parents granted orphan-drug status for Epidiolex one.” keeping detailed diaries for a month to es- as a treatment for Dravet and LGS. continued on next page tablish baselines prior to treatment with One of the benefits conferred is the Epidiolex. Patients continued taking the right to combine phase 2 and 3 clini- anti-epilepsy drugs they’d been on. They cal trials. The two phase 3 studies Conference at NYU Medical School in October 2013 featured a report by Orrin were started on Epidiolex doses of five —clinical trials— are taking place Devinsky, MD, on a Dravet Syndrome pa- milligrams per kilogram of body weight at various institutions around the US tient achieving dramatic seizure reduction per day, divided into morning and evening and in other countries. These studies by medicating with a 99%-CBD plant extract portions. The dose was increased weekly involve patients adding Epidiolex to from GW Pharmaceuticals. Other epilepsy by five mg/kg/day up to 25 mg/kg/day. their regimen of anti-epilepsy drugs specialists at US research centers are now us- In June 2014 GW announced efficacy for a 14-week randomized, double- ing GW’s “Epidiolex” in Investigational New and safety data on the first 27 patients to blinded treatment period. Results will Drug studies. Some 400 children were being have been treated for 12 weeks (the mini- be reported in early 2016. treated at 17 sites as of October 2014. O’Shaughnessy’s • Winter 2015/16 —31—

CBDevelopments from previous page

Bear in mind that a drug that is beneficial will transpire in the period ahead depends in treating the most severe forms of epilep- on many factors, including who is in the sy is likely to be beneficial in treating most White House and what actions the regula- seizure disorders. tory agencies take.

In March 2015 GW was issued a Rescheduling broached in the NEJM The topic of rescheduling specific can- US patent for CBDV in the treat- nabinoids was carefully broached in a re- ment of epilepsy view article in the New England Journal of Medicine (September 10, 2015) by Samuel In 2014 GW completed a Phase 1 clini- Friedman and Orrin Devinsky, two of the cal trial of its CBDV product candidate, epileptologists treating patients with Epid- GWP4200. Having established safety and iolex. “Relaxation of the regulatory status tolerability, they conducted a study of of cannabinoid-derived drugs, especially CBDV in people with focal seizures (vs those containing a high proportion of non- placebo). Next came a Phase 2 study in psychoactive cannabinoids, for which the adult patients with epilepsy. In March 2015 potential for abuse is low, could help to ac- GW was issued a U.S. patent for CBDV in celerate scientific study,” they wrote. Sanjay Gupta was shown CBD-dominant “Charlotte’s Web” plants by Josh Stanley on a CNN the treatment of epilepsy —“specifically They describe the work that has been report that aired in August, 2013. Stanley said, misleadingly, “There is nothing like this plant in the world. It is 21 percent CBD and less than one percent THC.” He and his brothers were for the control of generalised or temporal done to date with Epidiolex, which they soon inundated with requests from parents of epileptic children seeking Charlotte’s Web oil lobe seizures,” according to a statement by describe as 99% cannabidiol and less than extracts. A non-profit, Realm of Caring, was created to counsel patients and their families, the company. 0.1% THC. They note that randomized hundreds of whom moved to Colorado to expedite access to the promising new treatment. James Brodie had laid out GW’s com- clinical trials are underway for the treat- mercial strategy in an ICRS presentation. ment of Dravet’s syndrome and Lennox- ‘Charlotte’s Web’ By developing extracts and natural com- Gastaut syndrome. “No evidence suggests GW Pharmaceuticals’ research into the choactive. Harborside’s buyers —Rick pounds with specified ratios, he said, “you that the antiseizure effects of cannabidiol medical benefits of cannabidiol was re- Pfrommer, Rachael Szmajda, and Caroline can form a matrix of intellectual property are limited to the treatment of these condi- ported in O’Shaughnessy’s, starting with Francese— did their best to assure growers that will be safe. It is our belief and the tions,” they add. the first issue in 2003. For years pro-can- and producers of CBD-rich plants that they belief of our commercial partners that you While acknowledging the evidence that nabis doctors and their patients followed would have a market. cannot genericize Sativex.” THC has anti-convulsant effects, Friedman the news covetously, wishing that they, too, In the winter of 2011/12, when Paige Figi In May 2015 GW moved its corporate and Devinsky state that “Cannabis-based could investigate the medical uses of CBD. and her husband Matt (then deployed to headquarters from the UK to San Diego, treatment with THC may have irreversible But without an analytic lab testing the con- Iraq with Special Forces) were researching signifying a focus on the US market and effects on brain development,” and, as if tents of Cannabis plants, none containing epilepsy treatments on the internet, they heightening the fears of many small-scale it were a proven fact: “With longterm use CBD could be identified. Experts predicted were encouraged by an episode of a Dis- cultivators and their activist allies that GW there is a risk of addiction, which occurs in that no appreciable amount of CBD would covery Channel “reality show” in which will move against them in due course. Al- approximately 9% of longterm users.” remain in a plant population which, for Jason David, father of a little boy named ice O’Leary Randall asks, “Will the feds Friedman gets consulting fees from Ma- many generations in California, had been Jayden, describes his son’s first seizure- use the inevitable approval of Epidiolex as rinus Pharmaceuticals, Elsai, SK Biophar- bred to maximize psychoactivity. free day to Harborside’s Andrew DeAnge- a chance to crack down on growers in le- maceuticals, Upsher-Smith Laboratories, In late 2008 an Oakland start-up, Steep lo, the supplier of Jayden’s CBD-rich oil: gal states, all to protect the copyrights and and Pfizer. Devinsky gets grants from Hill Lab, began testing cannabis brought “I heard him humming,” the dad reported. patents that GW Pharmaceuticals and the GW Pharmaceuticals and Novartis. Their by growers to Harborside Health Center Paige Figi connected with Jason David, federal government hold on CBD?” NEJM article concludes with an oath of al- for mold and THC and CBD content (also through a social media group dedicated O’Shaughnessy’s posed her question to legance to the FDA approval system and a for CBN, cannabinol, a breakdown product to cannabis and epilepsy. Seven parents GW officials: how and under what circum- swipe at an alternative approach to CBD of THC that was thought to indicate time “chatted, shared info, looked into research stances might they assert the company’s distribution as a dietary supplement. in storage). together,” is how she describes it. At this intellectual property (IP) rights? Nobody “Despite the power of anecdote and the point, Paige says, she had “bought and wanted to be quoted by name. The respons- approval of medical cannabis by many From 2009 through 2012, very lab tested thousands of dollars of medical es included: state legislatures, only double-blind, pla- cannabis. Oil from the high-THC strains • Patenting products is standard proce- cebo-controlled, randomized clinical trials few dispensary operators were helped with some ailments and comorbidi- dure in developing pharmaceuticals, nec- in which consistent preparations of one or willing to stock cannabis that ties (sleep, appetite, autism, rage, etc.) but essary for “freedom to operate” conferred more cannabinoids are used can provide was not psychoactive. increased her seizures. One strain I found by regulators. reliable information on safety and efficacy. was working but they only had a few • IP rights would most likely be asserted The use of medical cannabis for the treat- Martin Lee and I arranged with Addison weeks’ worth of supply. When abruptly by requesting a licensing fee. ment of epilepsy could go the way of vita- Demoura and David Lampach at Steep Hill stopped, seizures increased.” • If “a major commercial player, not min and nutritional supplements, for which —and Harborside’s buyers— to be put in In February 2012 Paige gave Charlotte just a mom and pop, was clearly violating the science never caught up to the hype contact with the growers if and when any a dropper of oil that was effective. It had GW’s patent rights... we would look at our and was drowned out by unverified claims, samples were found to contain 4% or more been made by the Stanley brothers of Col- options.” sensational testimonials, and clever mar- CBD. About one in 650 samples turned out orado Springs. The Stanleys had launched Insys Therapeutics, Inc. has developed keting. If randomized clinical trials show to be CBD-rich by our arbitrary defintion. their “Indispensary” in 2009 and added a a synthetic CBD product for use by pa- that specific cannabinoids are unsafe or Martin and I shared with the growers second outlet in 2011. They were not pro- tients with Dravet and Lennox-Gastaut ineffective, those preparations should not what we had learned about cannabidiol cannabis activists. They knew that marijua- Syndromes, obviously taking advantage of be available. If studies show that specific from GW Pharmaceuticals’ presentations na was safe and effective medicine, having GW’s research. To date GW hasn’t moved cannabinoids are safe and effective, those at meetings of cannabinoid researchers. seen a family member get significant relief to curtail Insys —but Insys hasn’t moved preparations should be approved and made This was the start of Project CBD. from it as he was dying from cancer. And, to market its product. readily available.” It seems hard to believe, now that the as happens at every dispensary, the more A transdermal CBD gel is being devel- The image of CBD getting distributed as CBD bandwagon is so big and has so much feedback the Stanleys got from people with oped by a comany called Zynerba Phar- a nutraceutical was not hypothetical. It was momentum, but from 2009 through 2012, various ailments, the more convinced they maceuticals in Devon, Pennsylvania. What a reference to the Charlotte’s Web phenom- very few dispensary operators were will- became that cannabis has a vast range of enon. ing to stock cannabis that was not psy- continued on next page Project CBD

O’Shaughnessy’s front pages reflect the prog- Sean McAllister had reported on the ability of treating various symptoms —a complicated, involved). The donors of Harlequin, Omrita, ress of Project CBD. In 2008 (left), the lead CBD to kill certain cancer cells. By 2010 the longterm process we are still just at the start Jamaican Lion, and a few other CBD-rich story described work done in Europe by GW Society of Cannabis Clinicians and Harbor- of. Among the growers to develop or come varieties —not to mention Lawrence Ringo— Pharmaceuticals. By 2009 a California lab side Health Center were planning to collect across CBD-rich plants in 2008-09, most gave expedited the introduction of CBD to medical had begun finding CBD-rich strains, and data on the efficacy of CBD-rich cannabis in clones to Project CBD to distribute (no money cannabis users in California by two years. —32—O’Shaughnessy’s • Winter 2015/16

CBDevelopments from previous page became that cannabis has a vast range of not work. The ketogenic diet [an anti-sei- get anything… applications. But they hadn’t seen anything In February 2014 President zure diet low in carbs, high in fats] worked “Minnesota is just passing a bill that is like Charlotte Figi’s sudden and sustained Barack Obama signed into law for about six months and then seizures leaving post-traumatic stress and chronic improvement. a federal Farm Act allowing slowly started coming back... pain patients behind, and people who want The Stanleys guaranteed Paige a regular “At a very well known epilepsy center in to smoke it. They were assured that noth- supply of oil from the super-effective plant, Americans to grow industrial Southern California they casually pulled us ing else would pass. No one is for CBD- which they renamed “Charlotte’s Web.” It hemp for research purposes. aside and said ‘There’s really nothing else only. It’s tough... typically grew to a height of four feet and we can do for you guys, we suggest that “This trend started after the CNN show had a CBD-to-THC ratio greater than 20- Then in February 2014 President Barack you go home and enjoy your daughter as came out and pushed this new medicine for to-1. Some in Colorado assumed it had Obama signed into law a federal Farm best you can.’ So we went home very dis- seizures. So some of the states, that’s all been bred from a CBD-rich strain called Act allowing Americans to grow industrial appointed and upset. they’re willing to do. I can’t step away. If I R4. hemp, similarly defined. can’t support all the patients, I can support Word of Charlotte Figi’s progress circu- Assessing the market for hemp products some of them, whoever the state will allow. lated online and parents of epileptic chil- is a valid research purpose, so virtually “We’re just pushing and pushing and dren began contacting the Stanleys with ur- unlimited numbers of Charlotte’s Web and pushing, and we’re not going to stop until gent requests for oil from Charlotte’s Web. other plants containing 0.3% THC and, say, Charlotte’s Web is available everywhere. In July 2012, Paige, Mandy Stanley (Joel’s 8% CBD, could be grown in Colorado as We care about all of these patients. I travel wife), and Heather Jackson —whose son hemp. Oil extracted from such plants can- every week and I’m for everybody. This Zaki was the second child to benefit greatly not be labeled or advertised as a medical isn’t about a business plan that we’re try- from Charlotte’s Web— formed a 501(c)3 product, but it can be marketed as a dietary ing to push, this is about a socialized medi- foundation called “Realm of Caring” to in- supplement. So it was under the hemp ru- Heather Jackson moderated the Realm cine.” terface with other families. The RoC orga- bric that the Stanley Brothers chose to pro- of Caring Google Hangout in late May. In [Paige Figi was too young to know, I nizers would work as volunteers (unpaid) ceed. background, a graphic of her son Zaki, who gleaned in a later conversation, that the had been seizure-free for 19 months. for two years. There are seven Stanley bros, six in the politicians whose support she seeks would company called Stanley Brothers Social “We saw about eight or nine neurologists find the term “socialized medicine” slight- Demand Takes Off Enterprises, which is doing business as after that until we found one at UCLA who ly more offensive than motherf---er. Paige Sanjay Gupta’s “Weed” show in August, CW Botanicals —Joel, Jesse, Jon, Jared, was willing to sit down and listen to us and had combined those two words, logically, 2013, led to a flood of families contact- Jordan and J. (Just the initial. “My parents communicate and have a conversation. Our to describe her and Realm of Caring’s prin- ing Realm of Caring. “It was a 180-degree ran out of J names,” Joel jives.) There are neurologist is very supportive of the par- ciple that “no one should be denied Char- turnaround for us,” Paige says. “We knew four sisters, too, one of whom, Julie, works ents’ right to try something like CBD, es- lotte’s Web because they can’t afford it.” we’d have to ramp up for an influx of pa- at the company’s call center in Colorado pecially since we’ve tried everything else. I should have warned her not to use the tients, but didn’t realize how many.” Springs. Josh Stanley left “to pursue other I talk to him frequently and he’s interested political obscenity in earshot of Mitch Mc- opportunities” in March 2014. in the feedback about the patients, about Connell.] Colorado’s medical marijuana my daughter...” Paige reminded her RoC audience that program allowed them to grow Realm of Caring California “We want to do this whole thing legally, there was a real threat of Child Protective Among the parents of epileptic children so we’re creating a collective and resource Services getting involved whenever a child only six plants per patient, and who contacted Realm of Caring after the center so I can have all of you as my pa- was being given a Schedule I substance. Charlotte’s Web was a small plant. first Gupta show was Ray Mirzabegian of tients and we’ll do it as legally as possi- The fear, said Paige, “isn’t you going to Los Angeles. Mirzabegian, 40, rejected the ble… I am allowed to grow 99 plants in a prison, it’s CPS taking your child from The number of calls from families seek- suggestion that he move to Colorado be- facility —and that’s all I’m doing, because you. Until the scheduling is changed or de- ing information about Charlotte’s Web cause it would mean leaving his supportive I’m not planning on going to jail for years scheduled, we have to live with that.” jumped from 150 to several thousand a extended family in Southern California. He and years. But that makes it very tough and Heather Jackson added that after “almost month. Heather Jackson functioned as ex- started a Facebook group that soon had 200 forces us to have several facilities to meet every piece of press we do, someone calls ecutive director, maintaining the rapidly participants. Impressed, the Stanley Broth- the demand... the Department of Human Services on that growing waiting list for oil made from ers authorized Mirzabegian in February “It’s so hard for me to tell all 400 people family. There are counselors in hospitals Charlotte’s Web. Families began moving 2014 to grow Charlotte’s Web for distribu- to just hang in there and wait. I wish there who feel it’s their obligation to mandatory to Colorado to expedite access. The Stan- tion under the auspices of RoC California. was something I could do to make these report.” ley brothers ramped up production in their Mirzabegian and his two brothers dropped plants grow faster —and there is, but I’m • A question was asked about shipping greenhouses, but Colorado’s medical mari- their careers to become cultivators. not going to do it. Because I want to grow to other states. “It’s still a gray area,” Joel juana program allowed them to grow only In addition to lining up three greenhous- organically, no extra hormones or… (Ap- said. He was hopeful because “Charlotte’s six plants per patient, and Charlotte’s Web es and planting a crop, Mirzabegian orga- plause.)” Web qualifies as hemp and the Colorado was a small plant. Paige Figi began lobby- nized forums at which parents waiting for Department of Agriculture allows the ship- Charlotte’s Web Grown as Hemp ing for bills that would allow CBD oil to be Charlotte’s Web could get detailed updates ment of processed hemp products.” The In May 2014, Joel Stanley explained to made and used in other states. on the grow. The program included a talk Stanleys have been breeding for a higher a “Google hangout” for Realm of Caring Sanjay Gupta’s second “Weed” special, by pediatrician Bonni Goldstein, MD. Your CBD-to-THC ratio and are building out members —a video conference call—that which aired in March 2015, focused on correspondent attended an RoC California their lab facilities, he said. the company was growing 36,000 Char- families moving to Colorado to get Char- forum in Milpitas. lotte’s Web plants on 17 acres, thanks to lotte’s Web. The show had been taped when Transcribing the talks I could hear the September ‘14: list reaches 9,000 the legalization of industrial hemp. Also Josh Stanley was still the brothers’ spokes- steady singsong of infants in strollers and In September, 2014, Realm of Caring taking part were Paige Figi, Heather Jack- man. Gupta asked him to confirm that CBD the occasional moan of a teenager in a and the Epilepsy Foundation of Colorado son, Jesse and Jared Stanley (Googling in does not cause a high, and Josh smirked: wheelchair. The audience could not have held a get-together to discuss their progress from the grow site), and Ray Mirzabegian “You can set the whole hippie population been more empathetic. They were people with some of the doctors and others who in Los Angeles. Questions from viewers of Colorado loose on this plant and you’re who, when their kids became seriously ill, were attending a “Marijuana for Medical were sent to Heather, who read them aloud. just gonna be looking at a bunch of disap- curtailed everything else and devoted their Professionals” conference in Denver. The pointed hippies.” lives to caregiving. Ray Mirzabegian was harvest was weeks away. As if hippies’ kids don’t come down with telling his version of their own story. “Someday there will be no “It’s the first time that hemp has been epilepsy! As if hippies don’t get cancer! “I wanted this oil because my daughter waiting list,” Joel promised. grown on a crop circle under center-pivot As if Josh Stanley didn’t owe his liveli- was having many, many seizures,” said irrigation, which didn’t exist in 1937,” Joel hood to a gay, anti-war, Air-Force-vet hip- Ray. “She had tried 13 medications that did “Someday there will be no waiting list,” said. “Completely open, like corn. It took pie named Dennis Peron who cared for his Joel promised. “But right now, for those of us a while to find a field that hadn’t been friends with AIDS and wouldn’t let anyone you who are on the waiting list, I under- sprayed with pesticides the last couple of stop them from medicating with marijuana! stand that’s got to be torture. As a parent… years. But we were able to find one.” But Josh’s smarmy pitch did not and We really wish there was no such thing as The processed product —“CW Hemp does not detract from the real benefit that a waiting list. We’re doing everything we Oil”— would be distributed as a dietary Charlotte’s Web oil was and is providing to can to bring production to a scale where supplement. “We’re standardizing our plant pediatric epilepsy patients and others. Phy- there won’t be a waiting list.” extract at 30-to-1 CBD-to-THC,” Joel said. sicians monitoring its use —notably Drs. One purpose of the Google hangout was “That will be the only thing that’s stan- Bonni Goldstein and Margaret Gedde— at- to respond to detractors. The Stanley broth- dardized about this product. The terpenes test to its quality and consistency, and there ers and Paige Figi were being criticized for and minor cannabinoids will vary slightly could be no heavier endorsement. Gold- pushing so-called “CBD-only” legislation based on the plants they came from. stein credits Realm of Caring with keeping in other states. “In 2007 the FDA passed a final rule on the price low —5¢ per milligram— and Paige described her organizing efforts. dietary supplements and the quality stan- with reducing to zero a waiting list that “Some of these states are so conservative,” dards that must be met in terms of levels reached 12,692 by the start of 2015. she said, “they’re not going to allow the of microbiological contamination, residual This remarkable achievement was made solvents and heavy metals....We are going Ray Mirzabegian, director of Realm of Car- best bill, which is a full medical marijuana possible by two political developments. bill. To go in and say it should be for this for full GMP —good manufacturing prac- The first was the passage by Colorado vot- ing California, spoke to parents of pediat- ric epilepsy patients in Milpitas in Febru- type of patient only, and this kind of oil, tices. ers in November 2012 of Amendment 64. ary 2014, soon after he had begun growing non-smokable, for these syndromes only, Joel described the production cycle. “The Best known for legalizing adult use of mar- Charlotte’s Web plants. The number of pa- to play God, I think the whole thing is to- dried plants go through an alcohol extrac- ijuana, Amendment 64 also created regula- tients waiting for oil from RoC California tally ridiculous. But if people want a bill, tion and then a roto-vac is used to pull that tions for growing industrial hemp, defined was then about 400. As of November 2014, and they’re told by the people who can op- solvent off and we’re left with our concen- as cannabis containing no more than 0.3% the waiting list was 1,175 and Mirzabegian pose it and can trashcan it that they won’t trate, which usually comes out at 500 milli- THC when dried, for research purposes. was supplying a total of 81 patients. continued on page 34 —34—O’Shaughnessy’s • Winter 2015/16 CBDevelopments from page 32 grams per milliliter (mg/ml) and is 30-to-1 Hemp ready for harvest 10¢/milligram as of November 2015. RoC CBD-to-THC. We test it to get the precise members get a code which discounts it by ratio and for residual solvents. That oil is 50%. diluted with organic, food-grade olive oil CBD-rich plants grown by the Stanley down to 50 mg per milliliter.” Brothers in Kentucky will go into other November 2014: The Shipping News CBD products such as topicals, less con- The harvest in Wray turned out to be a centrated tinctures, and vape oils. The bumper crop, but in early November, cit- company keeps upgrading its technology ing the advice of counsel, the Stanleys an- for bigger batch sizes. Two supercritical nounced that they would not be shipping CO2 extraction machines were used in CW oil to patients residing in states other 2015, Joel said, and a third —“capable of than Colorado or California. Paige Figi, in- extracting roughly 620 lbs of pure CBD terviewed at the time, said “We’re trying per week”— is being delivered. to pass the federal bill so we can ship this, As for relations with the federal govern- and trying to pass state laws so patients can ment, “The FDA has not contacted us di- receive it.” rectly,” Joel says. “Nor were we included Nothing in Figi’s background prepared in the FDA warning letters concerning her to become a political organizer (al- unapproved labeling claims (as we do not though she did take a few pre-med courses make any claims). All of our products are at Colorado State). “Ten thousand bills are manufactured under strict GMP standards introduced and 1% get passed. Many are in an FDA registered facility, as all foods just to get media attention for their cause. and supplements sold interstate are regu- This is different. We are in this for passing lated by the FDA.” CBD-rich plants are examined by Jordan Stanley prior to historic harvest in late September, it, not just for attention.” 2014. Pipe overhead pivots to irrigate circular field. The plants were grown on 17 acres at an The Uruguay connection Charlotte, at age eight, has osteoporo- elevation of 3,500 feet. Oil extracted from them would supply some 3,000 patients with CW In 2014 the Stanley Brothers arranged a sis from longterm use of pharmaceutical Hemp Oil through the Realm of Caring foundation. Photo by Matt Nager. partnership with the first Uruguyan farmer AEDs has broken each of her legs in the licensed to grow hemp. Their plants will go past year. Her mother attributes her frail and use the oil because it’s federally ille- diet. As more people realize the potential into the ground in December 2015 —early bones to “permanent side effects of seizure gal.” The RoC California waiting list had general benefits of CBD, the total percent- summer in the Southern Hemisphere. (The drugs that never worked for her.” reached about 1,200 when the Stanleys age of RoC member sales is decreasing,” 2014 presidential election in Uruguay was Charlotte’s twin sister Chase has handled decided to ship CW hemp oil across state Joel says. in part a referendum on legal marijuana, the family tragedy “in the most stand-up lines in January. Only 25 ordered it imme- “The specific cultivars for Charlotte’s which was opposed by the center-right way,” says Figi. “She is Charlotte’s care- diately. As we go to press in late Novem- Web Hemp Oil are only grown in Colo- candidate. Left-leaning Tabore Vazquez, a giver. She’s a natural caregiver —a very ber, RoC is shipping to 325 Californians, rado,” he adds. Extraction is by alcohol, 74-year-old, pro-cannabis oncologist, won strong kid who has had to deal with a lot. and “several hundred” more are picking up as per the original process. “Most RoC with a 53-40 margin.) And she has gotten to see Charlotte im- their oil directly from Mirzabegian. clients prefer the original formulation. We Uruguay allows hemp to contain up to prove.” Mirzabegian’s original plan had been to don’t even grow it out from seeds, we keep 1% THC, which Joel Stanley calls “a sig- The siblings of seriously ill children open a Realm of Caring Health Center —a growing from clones and tissue culture.” nificant advance for hemp farmers. You are “have more responsibility,” Figi observes. bricks-and-mortar dispensary—in Los An- The retail price of CW Hemp Oil was continued on page 45 “They have loss of innocence at a young geles. The city attorney nixed the project age. They watch you to see how you [par- before it opened. For most of 2015 Mirz- ents] handle it.” abegian consulted with patients’ families Colorado Department of Public Health Matt Figi now works in Afghanistan as a by appointment at a North Hollywood dis- contractor for the U.S. military. Paige says pensary, NoHo’s Finest. In November he funding 9 medical marijuana studies that “getting called back home all the time opened the “Center for Complementary Cross Study Comparing the Analgesic Ef- on emergency leave” made a career in Spe- and Alternative Treatments” in Burbank. Amendment 64, passed by Colorado vot- ficacy of Cannabis versus Oxycodone — cial Forces impossible. “He didn’t want to Bonni Goldstein, MD, says admiringly: ers in November 2012, took effect in Janu- Emily Lindley, Dept. of Orthopedics, Uni- go into the Regular Army so he got out and “Ray has made himself very available —he ary, 2014. It legalized the sale of marijuana versity of Colorado School of Medicine. now he’s a contractor. He’s deployed more gives out his email and phone number— to adults over 21 and cultivation of indus- • Colorado Cannabis Cohort: Efficacy, now than when he was in the military.” and he takes hundreds of calls a day. He’s trial hemp (<0.3% THC). It also mandated trying to help those who are non-respond- that some of the tax money raised from Safety, and Usage Patterns of Medical “If we have any legal leg to ers to Charlotte’s Web.” ​ marijuana sales go to research projects to Marijuana for Sleep —Russell Bowler, be chosen by the state Department of Pub- National Jewish Health. stand on, how can we not?” With CBD-rich oil available from Colo- rado, Mirzabegian is growing strains with lic Health. Some 70 studies were proposed, • Placebo-controlled, Triple-Blind, Ran- including one by Realm of Caring that domized Crossover Pilot Study of the January 2015: the waiting list vanishes various amounts of THCA and THC and making concentrates which he distributes would have involved Charlotte’s Web in a Safety and Efficacy of Four Potencies of The decision to not ship CW oil to other under the brand name Canniatric. double-blind, placebo-controlled trial (but Smoked Marijuana in 76 Veterans with states was deeply disappointing to fami- “We grow and extract our own THC didn’t make the cut). Chronic, Treatment- Resistant Post Trau- lies waiting to be supplied, and the Stanley strains,” Mirzabegian says. “Our products In October 2014, nine projects were cho- matic Stress Disorder (PTSD) —Marcel O. brothers soon reversed course. “It was not are formulated based on parents’ and doc- sen to receive $9 million worth of funding Bonn-Miller, University of Pennsylvania unanimous,” Joel Stanley recounts. “But tors’ feedback.” In addition to tinctures, in the years ahead. and VA National Center for PTSD. with legal opinions coming down on every Canniatric makes a 10-gram syringe of • Do Adolescents and Young Adults with Although Sue Sisley, MD, is not the prin- side of the question, and children on the cannabis extract containing 2500 mg THC Inflammatory Bowel Disease Benefit from cipal investigator on the last-named study, waiting list dying, we felt, ‘If we have any and an equal amount of CBD. Use of Marijuana? Principal investigator: it is an expanded version of the one that legal leg to stand on, how can we not?’” As 2015 came to an end, Mirzabegian’s Edward J. Hoffenberg, University of Colo- she and the Multidisciplanary Association for Psychedelic Studies designed back in “Many want to try it but are daughter Emily was “one pill away from rado School of Medicine. weaning off Topamax,” her last AED. • A Randomized, Double-blind, Placebo- 2011, and which the University of Arizona still afraid because the DEA con- He thinks his most important role now controlled Crossover Study of Tolerabil- would not let her conduct. siders hemp illegal.” is to educate doctors about cannabis in the ity and Efficacy of Cannabidiol (CBD) on Sisley was fired from her U of A facul- treatment of epilepsy. “More doctors are Tremor in Parkinson’s Disease —Maureen ty position in July. She will be seeing 36 The national waiting list was 12,662 on needed,” he says, leaving unspoken “who A. Leehey, Department of Neurology, Uni- veterans with PTSD at a private office in in January 2015 when RoC headquarters know about the endocannabinoid system.” versity of Colorado School of Medicine Phoenix. A NIDA favorite named Ryan notified everyone that their oil was ready • Treating PTSD with Marijuana: Clini- Vandrey will see 40 vets with PTSD at to ship. The response was very surprising The 2015 Harvest cal and Functional Outcomes —Marcel Johns Hopkins University in Baltimore. — “anti-climactic,” to use Heather Jack- In 2015, according to Joel Stanley, the O. Bonn-Miller, Dept. of Psychiatry, Uni- The investigation will take three years son’s word: only 100 orders were received company grew Charlotte’s Web plants on versity of Pennsylvania, and VA National and cost $2,156,000 —making it the most right away. Over the next six months the 20 acres in Colorado —“more than enough Center for PTSD expensive of the nine studies Colorado is number rose by “about 3,000,” according to supply all the Realm patients with hemp • Cannabidiol (CBD) and Pediatric Epi- funding. to Jackson. oil.” At two smaller sites they lepsy — George Sam Wang, Department of The principal investigator, Marcel Bonn- Why did so many people grew out different strains Pediatrics, University of Colorado School Miller, was a two-time winner. His other on the waiting list not order and testing cultivation meth- of Medicine. state-funded PTSD study will look at peo- CW hemp oil when it became ods. Joel estimates that “RoC • Medical Marijuana in the Pediatric ple who obtain marijuana through Colora- available? members will utilize 50-60 Brain Tumor Population (palliative care) do dispensaries. They need not be veterans, Joel Stanley says, “Many percent of the harvest.” —Nicholas Foreman, Dept. of Pediatrics, although the Denver VAMC is listed as a want to try it but are still The company also grew Pediatric Neuro-oncology, Children’s Hos- source of potential study subjects, along afraid because the DEA con- hemp on 65 acres in Kentucky pital Colorado with the University of Colorado and “com- siders hemp illegal. Or their for an additional CBD supply • Use of Medicinal Cannabinoids as Ad- munity.” The budget is $1,181,127. neurologist or the local hos- and “to explore other uses — junctive Treatment for Medically Refrac- Is there anything to add to the under- pital won’t approve. Others seed, fiber, ethanol, etc.,” Joel tory Epilepsy (pediatric epilepsy) — Kelly standing laid out in Tod Mikuriya’s paper, may have found another op- said. “Although RoC member- Knupp, Dept. of Pediatrics, Children’s “Cannabis Eases Post-Traumatic Stress?” tion that worked.” ship is always growing, many Hospital Colorado and University of Colo- [Google “Mikuriya PTSD”] Ray Mirzabegian agrees: more people are buying CW rado School of Medicine. Maybe. Tod didn’t live to see CBD-rich “People are afraid to order products to supplement their • A Double Blind, Placebo-Controlled cannabis become available to his patients. O’Shaughnessy’s • Winter 2015/16 —35— Paige Figi wants you... Paige Figi has been lobbying Congress ‘I’ll never let this see the light of day.’ to pass the Charlotte’s Web Medical Access That’s what I’ve heard from leadership, Bill of 2015, which was first introduced in unfortunately. 2014 by Rep. Scott Perry of Pennsylvania. O’S: Leadership meaning Mitch McCon- This interview was conducted by manag- nell? ing editor Fred Gardner (no relation to the Figi: Yup. Grassley, McConnell, the other Colorado Senator). leaders that won’t let it happen. I think that O’Shaughnessy’s: Where do things stand if you can pass something now and help with the Charlotte’s Web bill? maybe five million people... That’s not Paige Figi: The Senate version of the enough, that’s not everybody. That’s not the Perry bill was introduced by Cory Gardner CARERS Act. But five million people is a of Colorado. Slight language differences, lot of people —people like my child, cancer but they’ll mirror each other when they patients... get through. We have the support of Orrin I have to focus all my attention on what I Hatch of Utah. He wrote the Dietary Sup- know. It’s so time consuming, it’s extremely plement Act in ’94. This bill puts CBD as a difficult. dietary supplement. O’S: How time consuming is it? How O’S: How does the Gardner CBD bill re- much time do you spend away from Colo- The Charlotte’s Web Medical Access Act of 2015 would “amend the Controlled Substances late to the Rand Paul/Corey Booker/Kristen rado? Act to exclude cannabidiol-rich plants from the definition of marijuana, and for other purpos- Gillibrand bill? Paige: You know, it looks like it’s more. es.” It states that “The Federal Food, Drug and Cosmetic Act shall not apply to cannabidiol I’m leaving for DC on Sunday again, for or cannabidiol-rich plants as those terms are defined in section 102 of the Controlled Sub- My bill is just a CBD and agricul- this. But I try and only travel when my hus- stances Act as amended by this Act.” Also, “Nothing in this Act shall prohibit or otherwise band is not in Afghanistan. tural hemp de-scheduling bill. restrict any activities related to the use, production, or distribution of marijuana in a State in O’S: He’s a contractor now? which such activities are legal under State law.” Paige: He is a contractor for now. So it’s Figi: The CARERS Act is a broad, very only the bare, bare minimum that I travel. If that. Because the state of Colorado Depart- Senate and House Judiciary Commitees. comprehensive bill … My bill, the Perry I can get a meeting, I only meet with poten- ment of Agriculture governs the crop and If you’re in a district of anyone on those bill, is one component of their bill. Theirs tial opposition and leadership—really criti- tests it, inspects it and it meets the definition two committees, we should be reaching has multiple components. One of them is cal meetings. I don’t just go chasing down of hemp under the federal farm bill, they out to them. Just educating them and ask- to de-schedule CBD. And my bill is just a the halls of the Senate and lobby like crazy. believe they’re in their legal rights to ship ing ‘Please co-sponsor this bill. … When CBD and agricultural hemp de-scheduling I only set up these private meetings where it. People are dying, this is ridiculous! The they’re in Washington, I can explain ‘This bill. CBD, that component in the plant, is I could be the most effective. I’m very ef- brothers decided to ship it to support par- is what you’re signing onto exactly’ and put removed from the Controlled Substances ficient is what I’m saying, and I don’t like ents. It’s the parents who have to face local them in touch with doctors and law enforce- Act entirely. And agricultural hemp is re- to be away from my children. law enforcement and make that decision for ment to answer questions. But first they moved from the Controlled Substances Act O’S: Who is against your bill? themselves. need to hear from their constituents. entirely. Separating those two things out Paige: There a large, a well-funded lobby I want to push that we have this really Also, we need the Democrats who are from the umbrella of the whole cannabis against this bill. I shouldn’t have said our powerful army of voices. And everyone for the CARERS bill. If they would see the plant that is on Schedule I. chances are 100%. Pharmaceutical interests is kind of scattered on so many different importance of this one piece of their bill, O’S: Don’t you think supporting the are lobbying against this bill, saying this bills happening. And if we could all align they can help five million people right now. Charlotte’s Web bill will give some politi- should not exist as a dietary supplement, and push them all, we could be a very, very Once they’re on board, all the Democrats cians cover not to vote for the broader bill? wait till it’s available from the pharmaceuti- scary force. I know there’s a lot of dissen- will see this as something they can support. Paige: Our bill was there before there was cal industry and paid for by insurance. sion, but there’s a majority now. If you poll Now they see it as a Republican bill, even a CARERS Act. There are politicians who To a Senator or Congressman who’s afraid the country, there’s over 50 percent in sup- though the co-sponsors are bipartisan. will never, while they’re in office, ever vote for their career might be swayed —’treat it port of medical cannabis. We don’t have for a comprehensive medical marijuana bill. like a pharmaceutical’ might seem like a funds, money on our side, but we have the Hemp should be an industry in They just will never do it. They would have quick, easy out. But it’s not a quick, easy numbers. this country. Why import it? never allowed for a hemp agricultural bill if out if you’ve got a two year old. O’S: Do you have any dealings with the not for Charlotte’s Web —even though it’s We say: Treat CBD like Vitamin C —a reform groups like Americans for Safe Ac- O’S: Do you have any allies? benign and harmless, they still would never dietary supplement that shouldn’t be owned cess or NORML? Figi: The Coalition for Accesss, a 501(c)4, sign onto it and let it pass. But people that and patented and pharmaceuticalized. It can Figi: I am in touch with them. I’ve heard is a platform for all the voices backing this opposed all of this before are saying ‘you be —that process can happen simultane- two different statements —they’re not in bill. Everyone told me it takes money to know what, I agree with this now that it’s ously, however long it takes— but it doesn’t support of CBD and then they are in sup- pass a bill and I didn’t believe it because CBD and hemp.’ They’re coming on board have to be. port of some of the CBD states. I’ve heard everybody knows that CBD helps these kids with this bill –people who are absolutely different back-and-forth on that. —it’s not controversial. I’m sad to say that opposed to medical marijuana. There are legislators who have The hemp industry is fully in support of it does take money. There are very few peo- O’S: What do you think the odds are that these bills. They’ve never been able to get said, “I don’t have anyone in my ple who don’t want this to pass, but they’re it will get through? Orrin Hatch or Lamar Alexander on board district that has epilepsy.” heavily funded. We have public opinion but Paige: 100 percent. for anything [without us] and they’ve been no funding. O’S: 100 percent? And what do you think trying for 15 years. The legislators need to hear from people. I have a leader in each state that collects the odds are on the CARERS bill? O’S: What were the changes that Perry There are legislators who have said, “I don’t advocates. If it’s a large state like Texas and Figi: I think there is no chance. It has to made in his bill between 2014 and 2015? have anyone in my district that has epilep- California, two or three. And they help all go through the Judiciary Committee and Figi: They added a sunset provision into sy.” And I’m like “You have one percent of the advocates that contact us either to do Senator Grassley will not give it his bless- the bill. They made it a little more conser- your district just with epilepsy alone!” media, go to DC, or when their legislator is ing. vative so that if the sky falls because you They’re just not hearing from anybody. on recess, ask them to co-sponsor it. O’S: Zero chance? legalized CBD and agricultural hemp, it We could put a dagger through the heart of So these parents go push our narrow mes- Figi: I wish it would pass. I want it to will sunset after three years. And then they the pharmaceutical lobby, because we have sage —they show pictures of their children pass. I’m in support of it. But when I sit changed the name, in the Senate bill to “The numbers and we’ve got an army. wearing helmets— and reach out and help down with the leadership, especially the Therapeutic Hemp Medical Access Act— O’S: Let me ask you a few questions drive up that advocacy number, drive up the people who have the ability to never let it S.1333.” about Colorado. Has the influx of patients co-sponsorship number. see the light of day, I’ve heard from them: O’S: It’s odd to see “cannabidiol-rich” de- slowed down now that you’re able to ship O’S: Many small reforms get sold to pro- fined in terms of THC content. “Therapeutic to so many other states? gressives as “a first step” towards bigger hemp” seems more accurate —although the Paige: There are still a lot of refugees reforms. And then they turn out to be all we Hemp Industry Association thinks it creates who come here for THC and THCA. And get —the last step, not the first. So there’s confusion. they come here for CBD —even Charlotte’s reason to fear that a CBD-only bill could Figi: This bill has a big chance of passing. Web— because even though they can get take the wind out of the sails of the medical They just need to hear from people. it shipped, they can’t go to the hospital in marijuana movement, like some people say O’S: Some observers say that having a Texas or Idaho and tell them they’re using a Obamacare took took the wind out of the CBD-only law in Florida hurt the chances Schedule 1 substance. They can’t tell them sails of Single Payer Healthcare. of the broader bill, Amendment 2. at school. They worry about local law en- But this situation could be different be- Figi: The CBD bill in Florida —the Char- forcement because it’s still illegal in their cause so many people are educated about lotte’s Web bill, they nicknamed it—exist- state. So there’s still refugees coming here. cannabis and know that THC is beneficial ed before Amendment 2. And I don’t feel We’ve lost a lot of advocacy for the coali- and in many cases necessary. And especial- that it did hurt, because people were made tion because people are like ‘It’s shipped to ly if you, Paige Figi, are committed to keep aware [of the medical benefits of marijuana] my door now. I don’t need to work this hard pushing for the CARERS Act. through the media around the Charlotte’s to change the laws.’ I’m hoping they realize Figi: Absolutely. And why make the Web bill. I think they actually help each this isn’t done until we federally amend the farmers wait? The farmers don’t care about other. scheduling. THC. They want this crop. Hemp should be O’S: What happens next to the federal O’S: How did you finally decide to ship an industry in this country. Why import it? Charlotte’s Web bill? across state lines? And the kids need CBD. Why is it ethical to Figi: The bills have to pass out of the Figi: The Stanley Brothers decided to make them wait? —36—O’Shaughnessy’s • Winter 2015/16 Introduced by Senators Paul, Gillibrand and Booker ASA pushing the CARERS Act Steph Sherer, Executive Director of Ameri- centrist. (See cartoon below by Andy Mar- medication needed to improve their quality cans for Safe Access, helped educate Kirsten lette of the Penascola News-Journal.) of life.” Gillibrand of New York and Cory Booker of In signing. Scott said, “As a father and A very skeptical, previously reliable source New Jersey on the need for changes in fed- grandfather, you never want to see kids suf- in Washington source says, “Feinstein and eral law to make marijuana available as a fer” —as if aunts and uncles just might. Grassley don’t want Charlotte’s Web, they medicine to all who need it. It’s understand- “Charlotte’s Web will ensure that children don’t want farmers here growing crops to able why Sherer strongly supports the CAR- in Florida who suffer from seizures and produce CBD, they want this thing locked up ERS Act —she had a hand in writing it. other debilitating illnesses will have the for the pharmaceutical industry.” Some backers of the CARERS Act fear that bills legalizing CBD will enable politicians to mollify constituents who want access to medical marijuana. These skeptics point to the 2014 vote in Florida, in which a ballot initiative to legalize medical marijuana (the whole plant, starring delta-9-tetrahydrocan- nabinol) fell less than 2% shy of the 60% needed for passage. Governor Rick Scott had stated that he would never allow any kind of medical Steph Sherer, Executive Director of Ameri- marijuana bill to be enacted in the Sunshine cans for Safe Access, speaking at ASA’s State. But during the campaign, strate- “Unity Conference” in Washington, DC, gists convinced him that signing SB-1030 March 28. Sherer launched the group in (dubbed “Charlotte’s Web” by the media), 2002, with support from dispensary opera- would make his opposition to medical mar- tors. Only four dispensaries had representa- ijuana seem less inhumane. With a stroke of tives at the 2015 conference. “Now we have the pen, Scott transformed his image from trade associations,” one of them explained. arch foe of medical marijuana to pro-CBD What it would do By Mike Liszewski On March 15, 2015, U.S. Senators Cory high-CBD extracts across state lines. Booker (D-NJ), Rand Paul (R-KY), and States that have not already passed full Kirsten Gillibrand (D-NY) introduced the medical marijuana laws or CBD-only laws Compassionate Access, Research Expan- would still need to pass such laws for pro- sion, and Respect States (CARERS) Act tections to be complete in those states. It —the first comprehensive piece of -medi is a fairly safe assumption that most, if not cal marijuana legislation to be introduced all remaining states without CBD protec- in the U.S. Senate. Americans for Safe Ac- tions would adopt such laws in the wake of cess was honored to have played a role in federal passage. shaping direction of the bill, and many of 5. CBD Determination by States the patient-focused issues we brought up This section was inspired by a similar were addressed in the final legislation. provision in the S. 134, Industrial Hemp The bill's introduction comes just a few Farming Act of 2015, which had a safety months after passage of the Rohrabach- valve provision for states that allow more er-Farr Amendment, which was guided than 0.3% THC in their CBD laws. ASA through the conference committee by the provided the Senate offices with language leadership of Senator Mikulski (D-MD). that will protect the patients in states that The Rohrabacher-Farr Amendment argu- allow 0.5% to 5% THC in their CBD laws, ably should have defunded the prosecution such as Alabama, Florida, Iowa, Missouri, of the Kettle Falls Five by the US Attor- South Carolina, Tennessee, and Virginia. ney for Eastern Washington, but the de- 6. Banking nial of their motion to dismiss shows that to continue to exist without any federal in- 3. Rescheduling of Marijuana The banking section of the bill used Rep. there is some legal dispute as to whether terference. Unlike the Department of Jus- The rescheduling portion of the bill is Perlmutter's HR 2652, the Marijuana Ac- Rohrabacher-Farr Amendment will end tice's August 2013 Cole Memo or even the probably the section that will get the most cess to Banking Act of 2013, as its basis. federal prosecutions. There is no question Rohrabacher-Farr Amendment to the DOJ criticism from patient advocates and oth- The provision would allow anyone acting that such prosecutions would end under the budget, this protection is both binding and ers. While placement in Schedule II does in conformity with their state marijuana CARERS Act, which states: permanent. ASA was successful in mak- not appear to be appropriate based on its laws to be able to access banking ser- “Notwithstanding any other provision ing certain that testing labs were included widespread medical acceptance and low- vices. This section would exempt banks of law, the provisions of this title relating along with producers and dispensers. The er abuse potential than other Schedule II from filing suspicious activity reports on to marihuana shall not apply to any per- exemption from the Controlled Substances substances like cocaine and methamphet- marijuana businesses. It would explicitly son acting in compliance with State law Act does two additional things: amine, it would show that the U.S. gov- forbid the federal government from penal- relating to the production, possession, 1) It will provide 280e tax relief to medi- ernment has finally accepted that there is izing marijuana businesses or incentivizing distribution, dispensation, administration, cal marijuana businesses (which should re- medical use for marijuana. banks to discriminate against legal mari- laboratory testing, or delivery of medical sult in lower prices for patients) and Placement on Schedule II could also po- juana businesses. 7. Research marihuana.” 2) It will allow state programs to go on tentially open up health insurance cover- Prior to introduction of the CARERS Act, unimpeded, regardless of where marijuana age to medical marijuana therapy, but that ASA urged the Senate sponsors to make many Senators have avoided taking an offi- is placed in the CSA, because the CSA will would not happen automatically. There are sure that the two biggest barriers to medi- cial position on medical marijuana because no longer apply in those states where medi- some who have expressed concerns that if cal marijuana research in the US were ad- there was no legislation in the Senate on cal marijuana is legal under state law. marijuana were placed in Schedule II that dressed, the Public Health Service Review the issue. Now Senators must confront it. it would mean pharmacies would have to Process and the NIDA monopoly on the Patient advocates and other stakeholders supply of available research marijuana. Section exempts state programs take over distribution and that pharmaceu- have an opportunity to discuss each of the tical companies would take over produc- The Obama Administration has already bill's issues in a substantive way. Rather from the Controlled Substances tion. removed the Public Health Service review. than decry any perceived shortcomings, Act, so they could continue to However, Section 2 of the bill, complete- The CARERS Act would end the single patient advocates can make strategic use of source monopoly for federal marijuana operate regardless of any poten- ly exempts state programs from the CSA, their time lending support to help get the so they could continue to operate regard- made available for FDA-approved re- bill heard before the Senate Health, Educa- tial implications of Schedule II less of any potential implications of Sched- search. This will help ensure that a greater tion, Labor, and Pensions Committee and status. ule II status. variety of marijuana is available to help offering suggested amendments to improve 4. Exclusion of Cannabidiol from Defi- foster meaningful research in the U.S. 8. Veterans the bill. This section creates binding and un- nition of Marijuana To help better understand the bill, below equivocal legal protections from federal The concept of this section of the bill ASA also urged the bill sponsors to in- is some section-by-section analysis (skip- interference for anyone abiding by their similar to Rep. Scott Perry's HR 5226 from clude a section that would allow VA doc- ping Section 1, which is simply the title of state’s medical marijuana law. the 113th Congress, but has been slightly tors to fill out state medical marijuana rec- the bill): It is unclear whether or not dual-licensed modified. This language would completely ommendation forms. 2. Federalism in Drug Policy medical/adult-use businesses would be remove derivatives of marijuana with less This is the section quoted above. It allows covered, but it appears they would for the than 0.3% THC content from the CSA, Mike Lisziewski is government affairs all state-legal medical marijuana conduct medical portion of their business. which would help enable transportation of director for Americans for Safe Access. —40—O’Shaughnessy’s • Winter 2015/16 Hemp closer to indica 2015 harvest Sativa / Indica Genetics Gap Quantified Thousands of acres of hemp grown Actual sativa (red) Strain name It has long been assumed that the differ- to indica (blue) ratio / reported % C. sativa ence between plants considered by cul- C. sativa (Laos) 100 in Kentucky, Colorado and Tennessee C. sativa (Thailand/Laos) 100 Dr. Grinspoon 100 tivators to be Cannabis sativa and plants Dr. Grinspoon 100 Neville’s Haze 90 In 2015 the Tennessee Department of that level of compliance is really quite considered C. indica was the result of dif- Neville’s Haze 90 Super Silver Haze 80 Alaskan Ice 70 Agriculture licensed 47 farmers to plant good,” Steenstra observes ferences in the genes determining cannabi- Indian Haze (or Haze Mist) 100 C. sativa (Guatemala) 100 hemp on 1,595 acres, and allowed impor- Bill Polyniak is a Kentucky farmer who noid content. But the differences are spread Arjans Haze #2 C. sativa (South Africa) 100 tation of 38,180 pounds of seed for them considers the hemp program “an absolute throughout the genome, according to a new NL5 Haze Mist 70 Arjan’s Ultra Haze #1 80 Hawaiian Snow 80 (almost all from Canada). But, as reported success.” Originally involved because he study by Canadian plant geneticists. Arjan’s Haze #3 70 Vanilla Haze 80 by Clay Duda in the Knoxville Mercury, has a son with epilepsy, Polyniak now sees The researchers analyzed 81 marijuana Lemon Skunk 50 Ata Tundra 0 Ken’s Sweet Tooth 60 “One shipment that arrived in Memphis hemp as a way to “revitalize” individuals’ and 43 hemp samples and found that “mar- C. Indica (Pakistan) 0 Raspberry Cough 70 was sent back to Canada after the carrier, lives and the overall economy. ijuana and hemp are significantly differ- Big Bang (autoflowering) 10 Super Lemon Haze 70 FedEx, discovered the package contained In 2015, Polyniak grew hemp in three entiated at a genome-wide level, demon- Neville’s White Widow 60 Bubba Kush 20 Arjan’s Strawberry Haze 60 hemp seed, which the company considered Bluegrass Country locations —two dedi- strating that the distinction between these Master Kush 10 Master Kush 10 a narcotic... Other delays were attributed cated to CBD oil production, one to seeds populations is not limited to genes underly- CBD Shark 20 C. indica (Afghanistan) 0 Cannatonic 50 to the DEA slow-walking necessary paper- for planting in the future. “I’m thinking ing THC production.” C. Indica (Afghanistan) 0 White Widow 40 work to import the seeds.” about 2025,” he says. “These children are The study, published August 26 on Jamaican Lambs Bread 100 Master Kush 10 So instead of planting in April and May going to need oil all their lives.” PLOS1, developed “evidence that hemp is Master Kush 10 Skunk Haze 55 Atomic Haze 90 —when fast-growing hemp would have After a CO2 extraction process in Ken- genetically more similar to C. indica type Almighty Whitey 50 A.M.S. 40 shaded out weeds— Tennessee farmers tucky, a portion of Polyniak’s CBD-rich marijuana than to C. sativa strains.” Big Bang 30 Big Bang 30 Blue Hell 20 were planting in June and July and their oil is trucked to South Carolina, where it is The authors concluded that there is a C. indica (Afghanistan) 0 Chemdawg 30 Cannabis had to compete with weeds. (The further refined, bottled and sold by a com- “moderate correlation between the genetic Cupid 50 Damn Sour 60 University of Tennessee had a one-acre pany called Palmetto Harmony —“created structure of marijuana strains and their re- Delahaze 70 Diamond Girl (Silver Pearl) 40 Domina Haze 85 hemp plot on which 15 herbicides and pes- after a collection of parents with special ported C. sativa and C. indica ancestry.” Durban Poison 100 El Nino 30 ticides were tested.) children ran out of options using modern They also found that “marijuana strain Exodus Cheese 40 GH Cheese 40 Great White Shark 20 FedEx —but not the DEA— was also re- medicine,” the website says. Palmetto Har- names often do not reflect a meaningful Happy Face 75 Hash Passion 0 sponsible for blocking hemp seed deliver- mony CBD products are sold at healthfood genetic identity” —confirming what Dr. Himalayan Gold 30 Ice Cream 50 ies from Canada to Kentucky farmers. The stores in South Carolina. Jeffrey Raber and other chemists have con- Island Sunshine 90 Jack Herer 40 Jenni 75 Kentucky Agriculture Department licensed Polyniak and his wife have developed cluded. Jocelyn 60 Kalishnikova 20 some 1,700 acres but only about 800 were their own brand of CBD-rich oil, “Genesis The reported ancestry of the 124 plants King’s Kush 30 King’s Kush 30 La Riena de Africa 100 planted, according to Eric Steenstra of Blend,” available through their Kentucky analyzed was determined via online da- Ladyburn 1974 Ortega BC 40 the Hemp Industry Association. Heavy Cannabis Company & Bluegrass Hemp Oil tabase searches, seed companies and li- Pennywise 30 Purple Sativa 70 sprintime rains also impeded planting. websites. The 2014 harvest enabled Polyn- censed cultivators. Co-author Darryl Hud- Rockstar OG Kush 15 Super Bud 220 Super Critical 30 In Colorado 166 farmers were licensed iak to get the price per milligram of CBD son (DOC Solutions in Ontario) estimated Trainwreck 60 White Berry 25 to plant 3,657 acres of hemp in 2015. below a dime. The 30 ml bottle holds 300 the identity of 26 strains for which no on- White Domina 0 White Rhino 20 White Rhino 20 Some 2,300 acres were planted, availabil- milligrams of CBD oil and provides 10 line information was available. Only three White Widow 40 strains were found to actually be 100% ity of seeds being the main limiting factor. milligrams per full dropper. (The dropper Colorado’s Agriculture Department also holds 30 milliliters.)A stronger extract of Sativa: Dr. Grinspoon, Neville’s Haze, and Lambs Bread and La Riena de Africa —all licensed 571,000 square feet of space for 1500 mg per bottle provides 50 mg of CBD Super Silver Haze. reputed to be 100% Sativas. indoor hemp cultivation. per dropper-full. Both strengths are avail- The graphic at right lists the strains test- Lead author Jason Sawler is with Anan- Most of the crops are going towards CBD able in larger 4 ounce bottles. ed and the ratio of Sativa (left hand part dia Labs in Vancouver and Dalhousie production. “Colorado tested 52% of the Polyniak has applied for licenses to culti- of each horizontal bar, in red) to Indica University’s Agriculture Faculty. The acres this year and only 8% were above vate 20 acres of hemp in 2016. The goal of genetics (right hand part, blue). How inac- study was planned by Sean Myles, also of 0.3% THC,” Steenstra says. Plants in only the breeding program is to maximize CBD curate the commonly used names can be Dalhousie, and Jonathan Page of Anandia one field were found to contain more than content, seed production and fiber quality is illustrated by the total absence of Sa- Labs and the University of British Colum- 1% THC. “Given the lack of certified seed, and quantity. tiva genetics in Durban Poison, Jamaican bia Botany Department. When Hemp Reigned in Kentucky the hemp. For the sake of it slaves were perpetually being In 1900, Macmillan published “The Reign of Law: a tale trained, hired, bartered; lands perpetually rented and sold; of the Kentucky Hemp Fields,” by James Lane Allen. If fortunes made or lost. The advancing price of farms, the published nowadays it would probably be shelved among westward movement of poor families and consequent dis- the romance novels. The heroine, Gabriella, comes from persion of the Kentuckians over cheaper territory, whither a wealthy family (even though they’ve lost their slaves). they carried the same passion for the cultivation of the She is a devout young woman, takes the Bible literally. The same plant,—thus making Missouri the second hemp-pro- hero, David, is the son of a devout hemp farmer. David ducing state in the Union,—the regulation of the hours in goes off to college and learns about evolution. He comes the Kentucky cabin, in the house, at the rope-walk, in the home, gets expelled from the church founded by his great factory,—what phase of life went unaffected by the pursuit grandfather, and feels the wrath of his father and the dis- and fascination of it. Thought, care, hope of the farmer appointment of Gabriella. He gets pneumonia and is near oftentimes throughout the entire year! death. He pulls through. He decides to go back to college “Let these men be the strongest.” and study the physical sciences. Gabriella, though her faith in Christianity is unwavering, will go with him. the latter, before those days ended with the outbreak of the The first chapter, “Hemp,” is a florid paean to its subject. Civil War, the country had become second to Great Brit- Some excerpts follow: ain alone in her ocean craft, and but little behind that mis- The Anglo-Saxon farmers had scarce conquered foothold, tress of the seas. So that in response to this double demand stronghold, freehold in the Western wilderness before they for hemp on the American ship and hemp on the southern became sowers of hemp—with remembrance of Virginia, plantation, at the close of that period of national history on with remembrance of dear ancestral Britain... land and sea, from those few counties of Kentucky, in the Hemp in Kentucky in 1782—early landmark in the his- year 1859, were taken well-nigh forty thousand tons of the tory of the soil, of the people. Cultivated first for the needs well-cleaned bast. of cabin and clearing solely; for twine and rope, towel and What history it wrought in those years, directly for the table, sheet and shirt. By and by not for cabin and clearing republic, indirectly for the world! What ineffaceable marks only; not for tow-homespun, fur-clad Kentucky alone. To it left on Kentucky itself, land, land-owners! To make way the north had begun the building of ships, American ships for it, a forest the like of which no human eye will ever for American commerce, for American arms, for a nation see again was felled; and with the forest went its pastures, which Nature had herself created and had distinguished as its waters. The roads of Kentucky, those long limestone a sea-faring race. To the south had begun the raising of cot- turnpikes connecting the towns and villages with the ton. As the great period of shipbuilding went on—greatest farms—they were early made necessary by the hauling of during the twenty years or more ending in 1860; as the great period of cotton-raising and cotton-baling went on— never so great before as that in that same year—the two parts of the nation looked equally to the one border plateau lying between them, to several counties of Kentucky, for most of the nation’s hemp. It was in those days of the North that the CONSTITU- TION was rigged with Russian hemp on one side, with American hemp on the other, for a patriotic test of the supe- riority of home-grown, home-prepared fibre; and thanks to “Then the fields are as the camp of an army.” Read more at BeyondTHC.com O’Shaughnessy’s • Winter 2015/16 —45—

CBDevelopments from page 34 no longer at risk of losing a field because of Inc., Dixie Elixirs, Bluebird Botanicals, behind this.’ And it was funny, one bad test result. Also, if we were to have Oasis, and CannaPet. These companies re- after about the second or third crops wiped out by hail —we’re dealing formulate the raw material —oil or paste— rally he would say ‘Watch this, with Mother Nature, after all— we would provided by CannaVest. “They re-texturize I bet you the first question is have a back-up.” it and refine it” Boucher says, “using their going to be about hemp.’ And Joel said he had no idea what share of own proprietary methods.” Then they re- of course it always was.” the market for CBD-rich oil is now be- package and relabel it in tinctures, edibles, Kentucky farmers made ing served by companies like Dixie and vape pens —even waxes for dabbing— un- three times more per acre Bluebird that have been purveying CBD der their own brand names. growing hemp in 2015 than extracted from hemp grown overseas — More than 150 dispensaries and 180 growing tobacco (which used to be government-subsidized), “anywhere from 5 to 50 percent” was his health food stores “carry our products in Chris Boucher with DEA permits authorizing CannaVest according to Boucher; and 10 guess. Starting with the 2015 harvest, he some form or another,” Boucher says. to import hemp seed from Germany destined for farmers times more than they would expects, some of these companies will be Cannavest also sells direct to consumers in Kentucky. extracting from CBD-rich plants grown in through its website —a sideline account- have growing corn. Colorado and Kentucky. ing for less than 10% of sales. He said hemp companies were pay- Noting that GW Pharmaceuticals had “I think those companies are planning to Founded in 2013, the company has cor- ing “anywhere from $1,800 a ton, dry opened an office in proximity to his in San do things similar to what we’re doing,” he porate headquarters in Las Vegas run by weight—that’s barrel-bottom price—for Diego, Boucher said: “I think they’re going says. “I can’t believe it’s cheaper to extract CEO Michael Mona. A partner in Dussel- the top 2.5 feet of their plants.” to move their growing operations here. At CBD from industrial hemp than from plants dorf coordinates the shipments from Eu- Companies purchasing hemp stalks plan the end of the day, I think the whole import grown specifically for CBD content.” rope. to make a wide range of products, from model might close down... The way this In October we asked Boucher if Can- horse bedding to fine textiles. CannaVest thing’s playing out in Kentucky, it could Hemp Oil Importers naVest was going to make use of the CBD- donated seeds to the Growing Warriors, a be that they can’t stop it because a lot of Among those attending the Hemp Indus- rich hemp grown in the U.S. “Our focus veterans group that is making American investment is going into it and there’s a lot try Association convention in Lexington, this year was on research,” he said. The flags from hemp. “They process it the old- of political power behind it.” Kentucky in late September was Stuart Ti- company gave a $47,000 grant to the Uni- time way,” Boucher says. “They watered Boucher says he gets from two to 10 tus, head of a company called MJNA that versity of Kentucky and $10,000 to Mur- down the fibers, use an old hemp brake, phone calls a day from California farmers has been a leading importer / distributor ray State, enabling agronomists (and grad take the fiber to hand weavers.” asking about their prospects for growing of hemp oil extracted overseas. We asked students) to study the optimal layout of Boucher expects to be scaling up in the hemp. State Attorney General Kamala Har- if checking out the situation in Kentucky hemp fields grown to maximize CBD pro- period ahead. He foresees a market of 40 ris has said that private farmers cannot en- presaged a new approach for his company. duction, analyze fiber content, and evalu- to 50 million Americans for cannabis, and gage in research and development —that’s Titus was forthright in response: “In Ken- ate harvest methods. a large subset looking for CBD. CannaVest the province of the Department of Food tucky the seed arrived late into the planting “The federal law says ‘research and de- will make tinctures and capsules marketed and Agriculture (CDFA) or institutions of season and the weather was not ideal later velopment’ and that’s exactly what we’re as nutritional products, depending on di- higher learning, according to Sacramento into the summer, so the crop was not as ro- doing. Researching what it costs to make rectives (or signals) from the DEA. “That’s attorney Patrick Goggin. bust as was hoped for. it, researching what it costs to sell it, re- where everything’s kind of in limbo,” he The CDFA “does not have the resources “In Europe, it was a good hemp season searching what it costs to distribute it adds. or interest in leading a project,” Goggin and we expect our usual annual crop and a across 50 states.” Boucher says there are misconceptions told O’Shaughnessy’s. “They are going to good amount of hemp-based CBD oil to be about the warnings sent by the FDA earlier leave it up to the University of California available to our distribution channels. “If you’re growing for fiber, are this year to companies that made claims at- and Cal State systems.” tributing curative properties to CBD, and Cannavest’s Boucher says, “Kentucky “Our overseas efforts with hemp produc- you going to throw that CBD in the tion, and product sales / development ef- lied on their labels about how much CBD will have a huge lead. California could forts are expanding.” flowers away? If you grow hemp for their products contained. The warning was miss out. I think there’s a lot more opportu- CannaVest is another major importer of seeds, why throw that CBD away? not a blanket injunction against distribu- nities here for farmers than anywhere else. hemp oil. “We believe that we are the larg- That’s money for the farmer.” tion of CBD-rich oil, according to Boucher, But, that’s my opinion.” est supplier of low-THC CBD oil in the but an outing of companies making false It will be “several years,” Boucher proj- claims. And CannaVest was blameless. ects, before hemp grown stateside will re world,” says their website. “Many farmers are doing ‘dual harvest,’ - “We sell to hundreds of different compa- place foreign hemp as the main source of The production chief is Chris Boucher, Boucher explained. “If you’re growing for nies, and some of those third parties were Cannavest’s CBD oil. “This year we’re who has been in the industry since 1990, fiber, are you going to throw that CBD in making claims. When we sell to people, we testing production methods, [determin when he started importing hemp goods the flowers away? If you grow hemp for - specifically tell them in the sales agreement ing] how many kilos we’re going to get per from China. In 1992 Boucher founded a seeds, why throw that CBD away? That’s that you cannot make claims and we’re not dried ton. As soon as we have that, we’ll trade group, the True Hemp Industries As- money for the farmer.” liable if you start making claims.” know how to scale up next year.” sociation, precedessor to the current HIA. Boucher credits Senators Mitch McCon- The CannaVest lab and processing fa- Other companies selling oil made from In 1994 he grew hemp at the US Depart- nell and Rand Paul and Kentucky Ag Com- cilities in San Diego have been inspected foreign hemp were also buying hemp ment of Agriculture research center in missioner James Comer for intervening by Dr. Jahan Marcu, Boucher says, and grown in Kentucky —and in Colorado and Brawley, California. The USDA was okay in 2014 when the Drug Enforcement Ad- they’re awaiting Patient-Focused Certi- Tennessee—in 2015. “We’re getting of with cannabis containing less than 0.3% ministration confiscated seeds before they - fication, having done the “minor things” fers right now at eight or nine cents a mil THC, but Governor Pete Wilson was not. could reach hemp farmers. David Bronner, - Marcu said they needed to do to comply ligram, coming out of Colorado,” Boucher The state overruled the feds. head of Dr. Bronner’s Magic Soap Compa- with all the relevant laws and codes. said in October 2015. “There’s definitely As explained by Chris Boucher, the oil ny, paid for the lawyers who got the crucial Marcu says that in mid-December he going to be a lot of oil.” arrives in San Diego in 25 kilogram buck- injunction that ended the confiscation. is planning to inspect a farm growing CannaVest faces competition from com ets as a thick tar, so dark green it looks “McConnell made them back down last - hemp for Cannavest in northern Germany. panies selling a crystalline form of CBD black. Some of this “raw” oil is sold di- year and this year the DEA didn’t interfere “They’re very conscientious about testing that —extracted with hexane— that is 99% rectly to customers. It contains chloro- at all,” says Boucher. “They were helpful, every batch, and they pay for the service — pure. “Powder is a formulator’s dream,” phyll, cellulose and waxes, and is “about in fact.” unlike almost everybody else in the indus- Boucher says. “All you’ve got to do is 15% CBD(A),” depending on the crop It was politically shrewd of McConnell, try,” Marcu said with a trace of bitterness sprinkle the powder into what you’re mak from which it was extracted, says Boucher. the Senate Republican leader (and faithful - in a late November phone interview. ing instead of putting this thick, gooey oil It wholesales for “about three cents per shill for the mine owners) to support the Waiting for Data in. But with 99% pure you lose the entou milligram of CBD.” hemp industry because he was facing a - The Kentucky harvest was beginning at rage effect and have to provide a much Most of the oil CannaVest imports gets serious challenge from a Democrat in No- the time of our interview, and Boucher esti- higher dose of CBD. Also, it takes a lot of decarboxylated in vacuum ovens at a pro- vember 2014. According to an observer of mated that CannaVest would be producing hexane to make a kilo of powder.” duction facility in San Diego. It is then pro- Kentucky politics, “He would go to town “Quite a few hundred kilos.” It will depend Boucher says CannaVest makes its pow cessed, Boucher says —distilled into “gold meetings and rallies, and the first question - on how efficient the innovative extraction der by mixing CBD-rich oil with rice pow oil,” which is about 25% CBD and costs —the first three questions— would always - technology turns out to be and variables der and heating until dry. about 5¢ per milligram. be about hemp. And he’s like, ‘Wait a sec- like how tightly farmers pressed the plant Some dispensaries in California and Boucher estimates that CannaVest will ond, this is a litmus test for the farmers. material. other states carry products made with CBD supply “close to 250 kilograms” of CBD If this is what they want, I’ve got to get oil to clients such as Medical Marijuana, “Unfortunately,” he adds “we can’t ship a oil extracted from foreign-grown industrial 1:1 ratio across state lines. Technically, we hemp. Imported by wholesalers like Can- can ship a 25:1 because the THC level is naVest, Endoca, and Elixinol, this high- so low. I almost feel like 1994 when I was CBD/low-THC oil is marketed primarily growing hemp at the USDA research cen- through internet storefronts and nutraceuti- ter in California. Everyone came after me, cal start-ups. said ‘you can’t do this, this is illegal.’ And I The Biosynthesis Pharma Group (BSPG) had a contract with the USDA, written and and Hempdiol are among the leading signed by the research center. wholesale distributers of CBD in the form “But I think this time everybody’s go- of a (nearly) pure, single-molecule powder ing to move forward because, watch out, derived from industrial hemp. CBD as an there’s some big players that are going to isolate lacks the therapeutic synergies con- jump in this game. They’re just sitting and ferred by whole plant cannabis oil, but it waiting for everybody to burn up all their may be an easier pill for THC-phobic regu- R&D money, develop the product, see how latory agencies to swallow. the market responds, and then jump in the Hemp extract is shipped from Germany to San Diego on pallets weighing about a ton. The Amy Farrah Weiss contributed to this article. cannabinoid-laden substance is then refined in myriad ways. game.”