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The duality of cannabis as a barrier for its use as a treatment for addiction

By Amanda Reiman PhD MSW

Schedule I Barriers

To understand the duality of cannabis, why this is a barrier to its use as a treatment for addiction, and how dispensaries fit into all this, it’s important to look at the impact of Schedule I and a Deontological Framework for drug use. There are beliefs in society that cannabis is recreational, curative and therapeutic. The investigation into these uses has been slowed by the Schedule I restriction in several ways:  1) It has slowed research into the components of the plant and its development into a pharmaceutical drug, interrupting the normal progression of botanical to medicinal discovery. So what we are just learning about the role of cannabis and addiction now, we could have known before; 2) It was labeled as having “no medical value” before any controlled efficacy studies had been done, and after people had been using it as a medicine for thousands of years. While petitions were being consistently filed to remove it from Schedule I ever since it was placed there, cannabis was gaining a reputation among users as being fairly benign and fun to use. Yet, even in the face of modern controlled studies of efficacy and the recognition of medical value in 16 states, the Feds remain adamant about keeping cannabis in Schedule I, WHY?

Drug Laws and Deontology

Drug laws are highly deontological, meaning that there is a belief that possession and use are inherently wrong regardless of the consequences. Cannabis policies are centered on prohibiting access regardless of the consequences of use. It is assumed that all illicit drug use is problematic and that is it NOT possible to be a responsible drug user. This is contrary to gun laws which are based on consequentialist beliefs. Gun policies are centered on regulating access and punishing consequences. Education is centered on safe use and avoiding unintended consequences. It is recognized that a small percentage of gun owners cause a majority of the problems. It IS possible to be a responsible gun owner. So, once cannabis was deemed wrong regardless of the consequences and Scheduled as having no medical value, it was very hard to justify changing that, regardless of the research on the health and social consequences associated with cannabis that have since emerged. Furthermore, it is extremely taboo to suggest that cannabis, a drug placed in the most restrictive category could be a treatment for a drug placed in a lower schedule (such as cocaine). At the same time, the government is funding research on cannabinoids as a treatment for among other things, addiction. This duality confuses the public, the industry and those who seek to regulate it, and distracts from the development of practical applications for cannabis in practice.

Cannabis as a Treatment for Addiction

So, how do we break free from this political and philosophical deadlock and move forward to reflect what we now know about the health and social consequences of cannabis and its potential as a treatment for addiction? The duality of cannabis as herb vs. cure is slowly tearing the issue apart. On one side, you have cannabis as wellness whether that is for therapeutic or recreational purposes. In this view, the use of the cannabis plant in its many forms (flowers, oils, fibers) is vital for maintaining a healthy balance within the body and for the health of the planet. This model most relates to the growing use of Complementary and Alternative Medicine in the United States. Individuals looking for alternatives to pharmaceutical drugs (from Oxycontin to Tylenol) are turning to acupuncture, chiropractic work, and herbal supplements such as cannabis. On the other side you have cannabis as cure. The discovery of the endocannabinoid system fueled research into the role of cannabinoids in the regulation of almost every bodily system. Pre-clinical research with animal models shows that cannabinoids such as THC and CBD have the potential to negate diseases such as cancer, HIV, Alzheimers, Parkinson’s Disease, and MS.

How does this duality and the role of dispensaries relate to an issue like substance use? As a treatment for addiction, both the herbal supplement and cannabinoid based medicine model apply, but in different ways. As an herbal supplement, cannabis in its raw form can be used as a behavioral substitute for the drug of addiction. Additionally, patients report that cannabis facilitates a mind/body connection which can help those in recovery tune into their issues rather than trying to numb them. Finally, the use of cannabis as an herbal supplement in its raw form can assist with harm reduction by helping patients get through moments of craving to stay within their own boundaries of drug use, and to move them from a more harmful substance, such as alcohol, to a substance that poses less harm like cannabis. Development is also happening on cannabinoid based medications for addiction. These medications work similarly to what report from the raw product, but at a more targeted level by interfering with brain messaging. Research on cannabinoids show the ability of these chemicals to block receptors in the brain stimulated by cocaine, which can help reduce cravings for the drug.  Furthermore, cannabinoid based medications have been shown to reduce the seizure activity associated with alcohol withdrawals, as well as prevent liver damage from excessive alcohol consumption. Granted, most of this research is not on humans, and most of the research on humans is anecdotal, but its thousands of years of anecdotal evidence.

What might cannabis treatment for addiction look like and how do dispensaries fit in? From the CAM perspective, cannabis based addiction treatment would encompass the alternative therapies such as acupuncture and mediation, along with the use of cannabis as flowers, tea, edibles, etc. as a method of easing the mind and changing behaviors while reducing harm. This is the model currently exhibited by dispensaries such as Berkeley Patients Group, Harborside Health Center, and SPARC.  From the FDA approved medicine perspective, cannabis based addiction treatment would encompass the use of medicines delivered perhaps by mouth spray such to prevent cravings, or an IV solution containing cannabinoids being given to an alcoholic in the hospital during detox. These interventions might be better suited for a hospital setting. Perhaps it is both, with utilization changing throughout the course of treatment. You cannot overdose on cannabinoids.

How are Patients Using Cannabis?

When asking medical cannabis patients about their reasons for use, we are already seeing these two sides come together in patient behavior, with both medical and wellness effects being reported. A chart review was performed on a sample of 175 patients seeking medical cannabis recommendations at a Northern California Medi-Cann clinic. The sample was 69.5% male, the mean age was 42.2, with a range of 19-86,  52.3% report a physical condition, 2.9% a mental health condition, and 44.8% both. Sixty nine percent of the sample reported using cannabis as a substitute for alcohol, illicit or prescription drugs.  The most common reason for substitution was less side effects from cannabis (24%). The benefits from cannabis most commonly reported were: Pain relief (85%); Sleep (77.7%); Relaxation (50.9%); Rx med substitute (46.3%); anxiety (46.3%). The benefits least commonly reported: Anti-Diarrhea (3.4%); Anti-Itching (3.4%); Prevent Seizure (3.4%); Prevent involuntary movement (5.7%). The bothersome effects most commonly reported were: Dry mouth (29.7%); Hunger (23.4%); Mood disturbance (17.7%). The bothersome effects least commonly reported were: Confusion (none); Dizziness (.6%); Palpitations (.6%); Movement problems (.6%). The benefits reported fit both the wellness model (relaxation, sleep) and the curative model (rx med substitute, anxiety, prevent seizure/involuntary movement).

Conclusion

While these two uses of the plant should be harmonious, these two sides may pull the issue farther and farther apart. This tension is reflected in the disagreements over the proper channels for cannabis regulation. What the two sides do not seem to realize is that: 1) cannabis in its many forms can be harmonious with the body, establishing balance, whether this is to maintain wellness or address disease; 2) stress relief and relaxation is absolutely a medical use, given the research on the role of stress in the development of disease; and 3) points one and two in no way mean that the entire family of cannabis products and preparations should be regulated the same way. We do not regulate wheat and beer the same way, nor do we regulate Valerian root and Valium the same way. The attempt to include both sides in any one policy is futile because the avenues for regulating herbal supplements and FDA approved medications are very different. If cannabis policy is to succeed in a way that honors the complexity of the plant and its many forms and uses, each camp might have to support each other and learn from each other, but head their own way. These treatments are complimentary, but they are not the same and should not be regulated the same way. It muddles the message and inhibits the use of cannabis in practice. A policy does not exist that would satisfy both these parties. Ironically, there are a myriad of practice situations, such as the treatment of addiction, that would be optimal both.

Quality Assurance Priorities for the Medical Marijuana Industry by Robert W. Martin, Ph. D.

Quality Assurance Priorities for the Medical Marijuana Industry

The Four Pillars of Quality; Product Safety, Truth in Labeling, Tamper evident Packaging, and Dosage

R.W. Martin, Ph. D.

Background

Since its beginnings at the turn of this century, California Cannabis Testing Laboratories have been focused primarily on cannabinoid testing.  The motivation for most users or dispensaries to use laboratories has been driven by the eagerness to find more potent strains and understand the potency of extant strains.  The discovery of more cannabinoids and the promising data surrounding the efficacy of CBD in particular has fueled even more interest in the further understanding of these cannabinoids.

Terpenoids (aromatic compounds associated with plants) have also been gaining interest of many of the Cannabis Testing Laboratories, at least within California, even though these compounds exist at almost trace amounts.  These terpenes are thought by some to be related to specific symptomatic issues relating to patient care. Others  believe that the terpenes enhance aroma therapy and taste of fresh products during consumption.  Preliminary investigations are underway in several laboratories to further identify and quantify these compounds in the various strains currently being commercialized.

To date, little emphasis has been placed upon the three pillars of Quality Assurance, namely 1) product safety, 2) labeling, and  3) tamper evident packaging that are usually considered major quality components in most consumer or patient-based delivery systems.  Dosage is added here as the forth pillar as it becomes very important to understand the strength of a certain medicine delivery system.  This emphasis is, in part, due to the fact that the experience base of most California Cannabis laboratories is primarily chemistry.  Hence, these chemist led laboratories play to their strength, and offer really top notch, very impressive chemical analyses to their patients.  There are labs that offer a wide range of cannabinoid and terpenoid profiling because they have the background to do so.  However, these cannabinoid and terpenoid analyses don’t begin to address the quality needs of the industry.  The following is a document that seeks to share existing concepts and principles of Quality Assurance and how they may relate to the medical marijuana industry in California.

1)    Product Safety

First and foremost in any Quality Assurance program is the concept of product safety.   In the medical marijuana industry,” products” refer to (1) the fresh prepared flowers as well as, (2) food processed with the infusion of cannabinoids:

1)     Prepared Flowers

It has been shown through testing that prepared flowers can yield very high numbers of bacteria and mold spores.  These high numbers, in most cases, indicate, for bacteria: poor handling or hygiene during processing and drying; and for mold the presence of a fungal species pathogenic or saprophytic on the flower.  High bacterial spore counts also increase the probability for the presence of human pathogens.  Pathogens such as Pseudomonas spp. have been identified on flowers grown and processed in California (CW Analytical file data).  Aspergillus has also been reported, a pathogen that produces Aflatoxin, an exocellular excretion known to be toxic to all mammals.

It has also been shown that residues of pesticides and fungicides can be present on prepared flowers, especially those grown indoors. These residues are known to sequester in human tissues and are implicated in a wide range of physiological disorders.

The minimum testing for QA approval of a flowered product=Residue Testing, Bacterial Screening, and Yeast and Mold Screening with potency testing optional (AOAC 986.33, 991.14, and 997.02).  Potency will be discussed in the Dosage Section below.

2)     Food processed with infusion of cannabinoids

Cannabinoid infused food should be tested similarly to food processed and distributed in existing food channelsThe minimum tests for acceptable Quality Assurance for edible food products infused with cannabinoids are= Bacterial Screening and Yeast and Mold Screening. (AOAC 986.33, 991.14, and 997.02) Potency will be discussed in the Dosage Section below.

2)    Product Labeling

The Sherman Food, Drug, and Cosmetic Law of 2008 clearly states that all food products be labeled accurately and consistently with standardized descriptions and labels (NLEA, 1991, Sherman Food and Cosmetic Act, 2008). This should be considered appropriate for both (1) prepared flowers as well as (2) food products infused with cannabinoids:

1)     Prepared flowers

Dried flowers should be tested, bagged and sealed prior to dispensing to patients. Vacuum, nitrogen flush and hermetic sealing are all options currently available. Efficient bagging will maintain freshness and guard against further contamination. Labels indicating date of bagging, level of testing (cleanliness), and potency (if desired) should be prominently displayed on each bag.

2)     Food processed with infusion of cannabinoids

All food products must be labeled using the 1997 convention adopted by the NLEA*. That is, all labels must include mandatory reporting of nutritional values based on serving size.  These values include calories, fat, protein, carbohydrate, cholesterol, sodium, Trans fat, fiber, sugar, with vitamins A and C, and iron.  Further, all potential allergens must be clearly identified and labeled to guard against accidental ingestion.  An ingredient statement in order of preponderance is also mandatory. Labels may be based on either calculated data or actual nutrition testing. Minimum requirement for label compliance= NLEA convention food label and accurate ingredient statement.

*= It is understood that some municipalities are uncomfortable with current labeling doctrine and that they seek to make packaging as different as possible to guard against mistakes with non-patients. CW Analytical strongly suggests that nutritional labels be offered at point of sale as information sheets or addendum added to the purchase of an edible in these situations.

 3)    Tamper Evident Packaging

 Tamper evident packaging should be required for all medical marijuana products whether fresh or processed.  The accidental exposure of non-patients to these medications should be taken very seriously and barriers such as these should be mandatory.

The US Code of Federal Regulations (21 CFR 211.132) defines OTC Drug tamper evidence as = – Tamper-evident packaging requirements for over-the-counter (OTC) human drug products:

“A tamper-evident package is one having one or more indicators or barriers to entry which, if breached or missing, can reasonably be expected to provide visible evidence to consumers that tampering have occurred. To reduce the likelihood of successful tampering and to increase the likelihood that consumers will discover if a product has been tampered with, the package is required to be distinctive by design or by the use of one or more indicators or barriers to entry that employ an identifying characteristic (e.g., a pattern, name, registered trademark, logo, or picture).”

Minimum requirement for medical marijuana industry = tamper evident packaging meeting requirements listed above

4)    Dosage

 Potency ranks fourth on the Quality Assurance priority as a nice to know datum point in one aspect and a need to know in another.  The potency of prepared flowers and concentrates is a nice to know in terms of commercial value and psychoactive potential but becomes a need to know datum point when calculating the potency for a dosage calculation in edible form*. Whether it be prepared flower or concentrate, the accurate depiction of cannabinoid levels are necessary for dosage calculations and serving size coordination to the patient. Minimum cannabinoid testing should include THC, CBD, and CBN values.

*It should be noted that there is currently no known dosage widely accepted for this industry.  Patient response to various dosages is very diverse and should be considered as a case by case basis.  CW Analytical recommends 20-25 mg as a standard single dose of THC.

 These opinions are respectfully submitted and based upon 30+ years within the food industry serving as a Director of Research and Quality Assurance in large multinational food corporations.  This document is intended soley for educational purposes and should be considered preliminary in scope and a precursor to formal ISO and HACCP program development. All questions should be directed to:

Dr. Robert Martin

Director, CW Analytical Laboratories

Oakland California

925-719-0463

robert@cwanalytical.com

 

Evangelical Pat Robertson Supports Legalization!

Pat Robertson tells the New York Times “I really believe we should treat marijuana the way we treat beverage alcohol,” Mr. Robertson said in an interview on Wednesday. “I’ve never used marijuana and I don’t intend to, but it’s just one of those things that I think: this war on drugs just hasn’t succeeded.”

Robertson argues that legalizing cannabis is a way to bring down soaring rates of incarceration and reduce the social and financial costs. His closing statement in the article is “I just want to be on the right side,” he said. “And I think on this one, I’m on the right side.”

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Cannabis Prohibition: Follow The Money

People are waking up to the REALITY of hemp and the corporate control of our lawmakers that keeps this resource illegal. Here is an example of the information circulating on the web.