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October 30, 2015
As you likely know, marijuana and hemp—two names for strains of the cannabis plant—are now legal for recreational use in certain parts of the U.S. As of October 2015 that’s true in four states (high there, Colorado!) and the District of Columbia. It’s also available for purchase for medical purposes in 20 additional states. Yet purchase, possession, and use of marijuana for either medical or recreational use remains illegal in 26 states in the U.S. These overlapping and contradicting state laws are due to the federal government’s ruling that individual states can pass laws to decriminalize or legalize cannabis.
While this may seem a little crazy, we have left the days of Reefer Madness behind. Now medical practitioners, disease sufferers, and drug and supplement companies continue to ask pragmatic questions about the viability of cannabis for medical applications. Those who use cannabis to lessen symptoms from their conditions and diseases often tout the benefits. However, when it comes to science, there’s little to back up these anecdotal claims. That’s not because these sufferers are wrong, but rather due to the fact that few clinical studies have been undertaken to demonstrate these claims.
Today, many legitimate companies recognize the vast potential of marketing and selling medicinal marijuana and hemp. But first they need to understand the risks and rewards of marketing and selling cannabis products. Confirming benefits through clinical studies is one of the best ways to do this.
Get it Legal
While you can buy marijuana, hemp, and the various chemicals contained in these cannabis plants in certain states, the FDA has not approved any natural derivative as a safe or effective drug for any indication. However, the FDA has approved synthetic, single-molecule cannabinoids such as Marinol® for use in anorexia associated with weight loss in patients with AIDS and nausea and vomiting associated with cancer chemotherapy. To date, the FDA still classifies marijuana as a schedule I substance, meaning that it not only has no governmentally established medical use, but the government believes it also has significant potential for abuse.
Due to this classification, legitimate companies who want to pursue this medical market space find it more challenging to perform clinical studies on these substances and sell products. To perform a clinical study on marijuana or hemp, a company must submit an investigational new drug (IND) application. The government then requires the approval of a new drug application (NDA) before a company can market and sell the drug.
One of the best ways to improve the medical benefits of supplemental marijuana or hemp for treatment is to significantly reduce or eliminate the psychoactive components of these herbs. This can potentially be achieved by making adjustments before growing or during processing after harvest.
This will likely increase the ability of cannabis to be treated by the FDA as a dietary supplement or food under specific circumstances. Regardless of how it’s consumed, cannabis has been demonstrated to provide support to the human endogenous cannabinoid system that’s involved in many important physiological functions, including motor control, cognition, emotional responses, motivated behavior and homeostasis. In addition, hemp seeds provide a significant amount of calories, deriving most of these from protein and dietary fats, allowing cannabis to potentially be regulated as a food by the FDA.
While hemp and marijuana are both forms of cannabis, differences exist between the two. Much of this is due to agricultural production—certain cannabis strains have been bred for the psychoactive effects, while others have been grown for sturdiness and oil production, allowing hemp to develop as an important resource for textiles. A further distinction is that hemp contains comparatively little THC (the molecule that gets you high) as compared to marijuana.
But hemp is, nonetheless, “high” in the molecules that are important to those with medical conditions. Primary among these is cannabidiol (CBD), a cannabinoid that positively affects bodily processes such as sleep, mood and appetite. Many companies including Dixie Elixirs & Edibles are on the forefront of these advances in cannabis science and medications.
The Lowdown of the High
Medical use of cannabis is not about a legal means to illicit drug usage however much it’s been used for this in the past (high there, California!). It’s about reducing suffering for those with medical conditions. Increased clinical research will help demonstrate the benefits that hemp and other strains of cannabis provide and potentially bring relief to many who suffer from these conditions and diseases.
One last note: I’ve included a list of resources in case you’d like to read more.
Christopher Baker is the CEO of Global Clinicals, Inc., an OTC and dietary supplement CRO based in Los Angeles CA, www.GlobalClinicals.com.
 https://en.wikipedia.org/wiki/Endocannabinoid_system  https://cannabias.wordpress.com/about-cannabis/which-nz-legislation-affects-medicinal-cannabis/is-cannabishemp-a-dietary-supplement-andor-a-medicine/
1. Mechoulam, Raphael, and Lumr Hanuš. "Cannabidiol: an overview of some chemical and pharmacological aspects. Part I: chemical aspects." Chemistry and physics of lipids 121.1 (2002): 35-43. Abstract: Over the last few years considerable attention has focused on cannabidiol (CBD), a major non-psychotropic constituent of Cannabis. In Part I of this review we present a condensed survey of the chemistry of CBD; in Part II, to be published later, we shall discuss the anti-convulsive, anti-anxiety, anti-psychotic, anti-nausea and anti-rheumatoid arthritic properties of CBD. CBD does not bind to the known cannabinoid receptors and its mechanism of action is yet unknown. In Part II we shall also present evidence that it is conceivable that, in part at least, its effects are due to its recently discovered inhibition of anandamide uptake and hydrolysis and to its anti-oxidative effect.
2. Zuardi, Antonio Waldo. "Cannabidiol: from an inactive cannabinoid to a drug with wide spectrum of action." Revista brasileira de psiquiatria 30.3 (2008): 271-280. Abstract:The aim of this review is to describe the historical development of research on cannabidiol. Method: This review was carried out on reports drawn from Medline, Web of Science and SciELO. Discussion: After the elucidation of the chemical structure of cannabidiol in 1963, the initial studies showed that cannabidiol was unable to mimic the effects of Cannabis. In the 1970's the number of publications on cannabidiol reached a first peak, having the research focused mainly on the interaction with delta9-THC and its antiepileptic and sedative effects. The following two decades showed lower degree of interest, and the potential therapeutic properties of cannabidiol investigated were mainly the anxiolytic, antipsychotic and on motor diseases effects. The last five years have shown a remarkable increase in publications on cannabidiol mainly stimulated by the discovery of its anti-inflammatory, anti-oxidative and neuroprotective effects. These studies have suggested a wide range of possible therapeutic effects of cannabidiol on several conditions, including Parkinson’s disease, Alzheimer’s disease, cerebral ischemia, diabetes, rheumatoid arthritis, other inflammatory diseases, nausea and cancer. Conclusion: In the last 45 years it has been possible to demonstrate that CBD has a wide range of pharmacological effects, many of which being of great therapeutic interest, but still waiting to be confirmed by clinical trials.
3. Bergamaschi, M. M., et al. "Safety and side effects of cannabidiol, a Cannabis sativa constituent." Current drug safety 6.4 (2011): 237. Abstract: Cannabidiol (CBD), a major nonpsychotropic constituent of Cannabis, has multiple pharmacological actions, including anxiolytic, antipsychotic, antiemetic and anti-inflammatory properties. However, little is known about its safety and side effect profile in animals and humans. This review describes in vivo and in vitro reports of CBD administration across a wide range of concentrations, based on reports retrieved from Web of Science, Scielo and Medline. The keywords searched were "cannabinoids", "cannabidiol" and "side effects". Several studies suggest that CBD is non-toxic in non-transformed cells and does not induce changes on food intake, does not induce catalepsy, does not affect physiological parameters (heart rate, blood pressure and body temperature), does not affect gastrointestinal transit and does not alter psychomotor or psychological functions. Also, chronic use and high doses up to 1,500 mg/day of CBD are reportedly well tolerated in humans. Conversely, some studies reported that this cannabinoid can induce some side effects, including inhibition of hepatic drug metabolism, alterations of in vitro cell viability, decreased fertilization capacity, and decreased activities of p-glycoprotein and other drug transporters. Based on recent advances in cannabinoid administration in humans, controlled CBD may be safe in humans and animals. However, further studies are needed to clarify these reported in vitro and in vivo side effects.
Cannabidiol Patient Data
4. Care By Design. CBD.org. 2015. 9.2015 Care By Design surveyed 2,495 patients who have been using medical marijuana for over 30 days. Survey responses were collected over a 6-month period of time between March and August of 2015. The survey asked medical marijuana patients about: • The conditions for which they are taking CBD-rich cannabis • The ratio of CBD-to-THC they are using • The impact of CBD-rich cannabis therapy on pain or discomfort, energy, mood, and overall wellbeing Seven hundred and three (703) people responded—just over 28% of those surveyed—suggesting that there is a pent up desire among medical marijuana patients to share their learnings and experience. In the final tally, we excluded incomplete submissions (55), and submissions from people who had not been taking cannabis for at least 30 days (27), leaving 621 completed surveys to evaluate.
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