Author Archives: Sparky

Cannabis Extract Opens New Door

Everyone is talking about how terrible it was of the DEA to create a number for Cannabis Extracts.  Well there is an upside to the situation.

All the attention is being made to the single mention of CBD being made a Schedule I substance.  Nothing is further from the truth, CBD is not a scheduled substance by the federal government.  NO Cannabinoid, with exception to THC, is a controlled substance according to the federal government.

What has been missed by everyone is the DEA’s statement about CBD extracted from the Cannabis Plant.  That they see no way for it to be extracted without extracting other Cannabinoids like THC which is a scheduled substance.   So there is no change in the stance of the DEA, there has actually been clarification that mixtures of CBD that contain THC and are extracted from the cannabis plants are extracts, those without are not.

What people have been missing is the opportunity to petition the DEA to De-schedule Extracts.  As extracts now have their own ID number they can be scheduled differently than Cannabis just as THC is scheduled differently.

The science is clear and evident that Extracts are by far safer than raw cannabis.  It’s easier to maintain dosage and test lots.  You can take a ton of cannabis and create and extract, test that batch for purity and level of cannabinoids and have a uniform product.  Unlike a plant which changes from plant to plant, even if cloned, extracts offer uniformity which is what the FDA likes.

Extracts make sense and it makes sense to De-schedule them or Re-schedule them into another schedule like THC has.

DEA, CBD, THC, Cannabis Extracts, Oh MY

There are lots of stories out there about how the DEA has classified CBD as a Schedule I substance. Nothing could be further from the truth.

This all stems from the DEA announcement of a new code for Cannabis Extracts.  Cannabis extracts are just that extracts from the Cannabis plant.  In the initial filing in 2011 the DEA stated:

The United Nations Conventions on international drug control treat extracts from the cannabis plant differently than marihuana or tetrahydrocannabinols. The creation of a new drug code in DEA regulations for marihuana extracts will allow for more appropriate accounting of such materials consistent with treaty provisions.

In the announcement DEA clarified a question brought up in a comment:

One comment requested clarification of whether the new drug code will be applicable to cannabidiol (CBD), if it is not combined with cannabinols.

DEA response: For practical purposes, all extracts that contain CBD will also contain at least small amounts of other cannabinoids.[1] However, if it were possible to produce from the cannabis plant an extract that contained only CBD and no other cannabinoids, such an extract would fall within the new drug code 7350. In view of this comment, the regulatory text accompanying new drug code 7350 has been modified slightly to make clear that it includes cannabis extracts that contain only one cannabinoid.

The operative words are produced from the cannabis plant.  This means just that produced from the plant itself and, that any synthetic cannabinoid is exempt from the code classification.

They again reiterate this in their final action:

“Meaning an extract containing one or more cannabinoids that has been derived from any plant of the genus Cannabis, other than the separated resin (whether crude or purified) obtained from the plant.”

The same would be true for THC extracted from the plant.  As an Extract it is a schedule I substance.  However THC produced in a Lab remains in it’s current schedule.  The difference is one is extracted from the plant the other is produced by a combination of chemicals and processing.

The DEA has done nothing with CBD, there has been no scheduling change, there is NO DRUG CODE for CBD.  If it is extracted from the plant then it is an Extract and Schedule I if it is made synthetically it’s a different story. You can see what is on what schedule at this link – DEA List of Controlled Substances and Drug Code

CBD is not in the controlled substance schedules or controlled by the DEA.  Provided it is not extracted from the Cannabis Plant.

DEA and Marijuana Extract Means.. NOTHING

On Dec 14th the DEA announced a new drug code for “Marijuana Extract” and there has been a lot of furor over the decision.  For those that have read the CSA and understand the meaning of the definition of “Marijuana” it already meant:

The term “marihuana” means all parts of the plant Cannabis sativa L., whether growing or not; the seeds thereof; the resin extracted from any part of such plant; and every compound, manufacture, salt, derivative, mixture, or preparation of such plant, its seeds or resin. Such term does not include the mature stalks of such plant, fiber produced from such stalks, oil or cake made from the seeds of such plant, any other compound, manufacture, salt, derivative, mixture, or preparation of such mature stalks (except the resin extracted therefrom), fiber, oil, or cake, or the sterilized seed of such plant which is incapable of germination.

Prior to this announcement everything other than THC, which already has it’s own drug code, all other Cannabinoids were classified under the Marijuana Code.  What this does is separate out for purposes of clerical and data collection a difference between raw Cannabis plant material and Extractions made from the plant.

NOTHING has changed, no substance scheduling has changed, no laws have been changed.

So what does it really mean?  What it really means is that now the extracts that researchers have been getting from the Mississippi Farm now have a separate code.  This allows the DEA, FDA, HHS, NIDA to track what kind of research is being done.  Is it whole plant or an extract that is being used.

Frankly it wouldn’t be a bad idea to put each cannabinoid it’s own drug code.  This could do two things.  First it would track what research is being done with what cannabinoids.  It could also lead to many more cannabinoids being put into different schedules like THC is in a different schedule.  One by one move the cannabinoids to other schedules and you less reason to keep the whole plant scheduled in schedule I

 

Pharmacists want more information

pmcIn a First of it’s kind study posted to PubMED shows that pharmacists want more information about medical cannabis.   The study conducted in Minnesota prior to Minnesota’s medical Cannabis program implementation shows that Pharmacists want more information on medical cannabis.  The Study was done by Joy Hwang, PharmD, MPH, Tom Arneson, MD, MPH, and Wendy St. Peter, PharmD

First the report determines that Minnesota Pharmacists, in general, have limited Knowledge of cannabis polices, regulations and felt they were not adequately trained.

Pharmacists reported limited knowledge of Minnesota state-level cannabis policies and regulations and felt that they were inadequately trained in cannabis pharmacotherapy. Most pharmacists were unprepared to counsel patients on medical cannabis and had many concerns regarding its availability and usage. Only a small proportion felt that the medical cannabis program would impact their practice. Pharmacists’ leading topics of interest for more education included Minnesota’s regulations on the medical cannabis program, cannabis pharmacotherapy, and the types and forms of cannabis products available for commercialization.

Unlike most states which have legal medical Cannabis Minnesota and a couple others have Licensed Pharmacists as the dispensers.  However in Minnesota these pharmacists are trained by their respective companies and have a great deal of knowledge about Cannabis use for medical purposes.

In these three states, pharmacists provide registered patients with consultations at one of the state-approved cannabis distribution centers. Moreover, they are the only health care professionals who are permitted to dispense cannabis products. This distinguishes these states from most other legalization states, where cannabis products—both medical and recreational—can be purchased from retail dispensaries that operate under the guidance of certified personnel known as “budtenders.”

The study was done to assess gaps in knowledge and concerns of Minnesota pharmacists.  The study conducted voluntarily via a web-based survey and had a 10% response rate by the states Pharmacists. The questionnaire had 14 questions they asked the pharmacists and also room for them to put in their own comments.

The majority of the respondents completed the survey and reported little concern about medical cannabis.

Most pharmacists rated themselves on the lower end of the Likert scale for self-perceived knowledge about medical cannabis and readiness to counsel patients on medical cannabis use (1 = poor; 7 = excellent) and concerns about medical cannabis use under the Minnesota program (1 = no concern; 7 = most concern)

Almost 90% of the respondents responded that they were less than moderately prepared to provide counseling services to patients using cannabis for medical purposes.

Pharmacists in general want more education.  This survey is of all pharmacists registered in Minnesota. Of those only a small number of them actually work with cannabis patients in the clinics that are available.  However it’s clear from this study that they want more education on Cannabis.

Respondents were very interested in learning more about medical cannabis in the following areas: state-specific rules and regulation (87%), pharmacotherapy (88%), and available types and forms of products on the market (82%). Fifty-three percent were interested in learning more about federal laws related to marijuana. Only 7% indicated no interest in learning more about any of these topics.

The study was conducted 2 months prior to Minnesota implementation of it’s cannabis program and there was a great deal of confusion about it.  Since the time of the survey information from a variety of sources including educational presentations to many hospitals, clinics, and hospital-clinic organizations in Minnesota with pharmacists as part of the audience, The University of Minnesota College of Pharmacy, Medical School and School of Nursing, full-day educational symposium on medical cannabis in April 2016, the Minnesota Pharmacists Association (MPhA) and the Minnesota College of Clinical Pharmacists.

The Study Concludes:

This study suggests that Minnesota pharmacists were not sufficiently prepared to work with patients in the medical cannabis program. Of those who provided survey responses, an overwhelming majority felt incompetent in medical cannabis clinical knowledge; however, almost half were unconcerned about the potential impact the program’s implementation would have on their practice. Nonetheless, pharmacists were interested in learning about medical cannabis and its state-specific regulation. Targeted education regarding cannabis pharmacotherapy, product availability and variability, and state-specific regulations should be available for health care professionals practicing in states with medical cannabis programs prior to program implementation and patient access.

 

Link to the study here – LINK

Copy of the study here – minnesota-pharmacists-and-medical-cannabis_-a-survey-of-knowledge-concerns-and-interest-prior-to-program-launch

 

WHO – Systematic Review of Cannabis Safety

who-report-safeIn a report to the upcoming WHO conference another report has been issued about the safety of Cannabis and it’s use in medicine.

The report acknowledges thousands of years of historical use of cannabis for medical purposes.  Unfortunately due to the limited number of published scientific studies on the few conditions they studied they didn’t find definitive proof of cannabis efficacy in the treatment.

What they did find is that in all cases there weren’t adverse side effects like other medications.

In regards to adverse events, the included studies considered many adverse events, the majority of them were of low to moderate gravity. For the most serious adverse events (i.e. CNS side effects, depression and confusion) no differences were observed between cannabis and placebo. Incidence of general psychiatric disorders was higher in the cannabis groups but results came only from two small studies (92 participants). In addition, frequency of dissociation was higher in the cannabis groups, and no studies considered the development of abuse or dependence.

The report Titled “Systematic reviews on therapeutic efficacy and safety of Cannabis (including extracts and tinctures) for patients with multiple sclerosis, chronic neuropathic pain, dementia and Tourette syndrome, HIV/AIDS, and cancer receiving chemotherapy Laura Amato, Marina Davoli, Silvia Minozzi, Zuzana Mitrova, Elena Parmelli, Rosella Saulle, Simona Vecchi DEPARTMENT OF EPIDEMIOLOGY LAZIO REGION, ASL ROMA 1 – ROME, ITALY”

Can be found at the following link – LINK

or we have archived it here – systematic_reviews_on_therapeutic_efficacy_and_safety

Therapeutic Cannabinoid Research

WHO Pre-review Report Cannabis and Cannabis resin

With the upcoming meeting of the World Health Organization (WHO) Expert Committee on Drug Dependence Thirty-eight Meeting in Geneva, on 14 – 18 November 2016 many are calling for Cannabis to be an agenda item.

coverIn a pre-view Report “Cannabis and Cannabis Resin Pre-Review Report A document prepared for the World Health Organization” was prepared by H. Valerie Curran, Philip Wiffen, David J. Nutt, Willem Scholten.  In their report they give all the reasons why Cannabis should be more than an Update Item on the agenda.

In their report to the WHO they state in the preface:

In the eighty years since cannabis and cannabis resin were last reviewed by the Health Committee of the League of Nations in 1935, both the social context of cannabis use and the science of drug dependence have dramatically changed. Yet, cannabis and cannabis resin continue to remain under the strictest control regime possible under the Single Convention, without a valid scientific re-assessment of this decision. Cannabis and cannabis resin are listed in Schedule I and Schedule IV respectively, which means that both remain strictly prohibited worldwide.

then adding that the WHO is acting in a manner that appears to make continued prohibition illegitimate

The current scheduling of cannabis is in marked divergence with the Convention’s principle that scheduling of substances should be based on a scientific assessment by WHO. In the absence of a recent assessment, the continued prohibition of cannabis appears completely illegitimate even though it may be legal.

38ccdThey then proceed to ask the WHO to conduct a Scientific Review of cannabis and cannabis resin

A scientific review by the WHO, the only authoritative global body to make such an assessment, would greatly legitimize international policies and their national implementation. A scientific assessment of cannabis and cannabis resin appears most timely given the many debates that have emerged on this issue across the world in recent years.

In the fifty years since it’s inception the WHO has never conducted a scientific review of cannabis.  Despite it’s mandate to review the substance.

The scheduling under the Single Convention on Narcotic Drugs assumes a scientific justification. However, cannabis and cannabis resin have never been evaluated by WHO since it was mandated the review of psychoactive substances in 1948.

The purpose of the pre-review report is to clarify the position of the current state of use both medically and none medically.

The purpose of a Pre-review is to determine whether current information justifies a Critical Review. For evaluating substances in a Pre-review, the categories of information are identical to those used in Critical Reviews. At the stage of the Pre-review, the Expert Committee must decide whether the information justifies a Critical Review. If it finds that the data available may justify changing the scheduling of cannabis and/or cannabis resin, the Committee should recommend a Critical Review in its next Meeting.

The 53 page report, or 75 with cites, covers everything from adverse reactions, LD50 level, and pretty much everything you ever wanted to know about cannabis and how it works.  The report is remarkable in it’s completeness.

Conclusions Despite that the scheduling system of substances under the Single Convention on Narcotic Drugs is supposed to be based on scientific assessments, the WHO has never reviewed cannabis and cannabis resin. This means also that the Expert Committee continues to recommend that cannabis is not to be used medically despite growing evidence of considerable medical use world-wide, including the availability of a pharmaceutical preparation with a marketing authorization in multiple countries. Many countries are struggling with the impact of the prohibition of cannabis with its wide negative impact on societies (including through human rights violations) and on drug markets and drug use, including on the market of synthetic cannabinoids.

Committee recommendations are needed on the following topics:

1. Whether a Critical Review should be conducted for reviewing the current scheduling in Schedules I and IV. Each of the following reasons would justify a recommendation for a Critical Review: a. because WHO has never conducted a Critical Review, meaning that there is no scientific justification for the current scheduling; b. because the wide-spread medical use, including the use of preparations with a marketing authorization is in contradiction to listing in Schedule IV; c. because it is not clear whether the dependence-producing properties of cannabis and cannabis resin are between codeine and morphine (justification for Schedule I) or between dextropropoxyphene and codeine (justification for Schedule II) or below those of dextropropoxyphene (justification for not scheduling).

2. On the medical use of cannabis and its preparations (which can include revoking old recommendations by the Committee)

3. On the need of quality control on cannabis and cannabis products for medical and non-medical use.

Here is a link to the piece – LINK

Here is the report itself just in case it disappears from the net – whocannabisreport

Therapeutic Cannabinoid Research

Social Media and Cannabis

Everyone knows that you can follow all kinds of groups, organizations and such that are in favor of Cannabis but are you using social media to it’s full extent?  What about all those Representatives in Congress?  How about the FDA, Department of Justice, NIDA, NIH, and countless others?

It’s easy to follow them and depending on who they are they may send out lots of information or very little.  In any case it gives you an opportunity like we saw in a recent FDA post about Opiate addiction.

fda-faceHere the FDA is talking about the Surgeon General and the national Opiate Epidemic sweeping the United States.

This gives more than one person an opportunity to confront the FDA about the medical use of cannabis.  Present information that the use of opiates is down in states that have legalized cannabis.

Surprisingly the FDA responded to at least one of the comments with a link to their website.  Interestingly enough the information the FDA provides on it’s website link is both wrong and also opens new questions.

Are you using your use of Social media like Facebook to keep yourself informed and also have an opportunity to present information to the millions of people who also follow these groups?

Then there are your representatives both locally and federally.  All of them have Facebook Pages.  Follow them, look for opportunities to make intelligent comments that deal with Cannabis.  You would be surprised the number of opportunities you can have to not only educate your representatives but also those who are also following them.

This tactic also works great with Call in Radio programs, which is frankly where we got the idea.  Our founder used to call into one Talk Radio program so often he had his own theme music.  He looked for opportunities to be able to call into the program and turn the conversation to Cannabis.

fda-face2Social media gives you another opportunity to educate people about Cannabis.  Get out there and like pages of those who represent you and also the agencies that regulate you and get an opportunity to express your voice about Cannabis.

 

PTSD Clinical Trials Recruiting

clinicalEugene Applebaum College of Pharmacy and Health Sciences is currently recruiting patients for a Therapeutic Cannabinoid Research program for treatment of PTSD.

The goal of this study is to look at how a type of drug called cannabinoids are related to the processing of fear signals, the experience of emotions and fear, and the pattern of activity in the brain that is involved in these processes and how this relates to the development of post-traumatic stress disorder (PTSD). PTSD is an anxiety disorder that occurs after experiencing a traumatic event(s) and is characterized by unwanted memories of the trauma(s) through flashbacks or nightmares, avoidance of situations that remind the person of the event, difficulty experiencing emotions, loss of interest in activities the person used to enjoy, and increased arousal, such as difficulty falling asleep or staying asleep, anger and hypervigilance. The information gained from this study could lead to the development of new treatments for persons who suffer from anxiety or fear-based disorders.
This study which has been waiting to start since Feb of 2014 is currently recruiting patients.  You can find more information on how you qualify, and who to contact at the following link.  This link takes you to ClinicalTrials.Gov a site not affiliated in any many with us.

Cannabinoid Control of Fear Extinction Neural Circuits in Post-traumatic Stress Disorder

Therapeutic Cannabinoid Research

 

Subterranean Marijuana Grow Room

In January of 2015 the DEA felt it necessary to issue a bulletin because of the discovery of an Underground Grow room.  In a FOIA request we wanted to see what they had to say and it wasn’t much.

dea-underground-growBasically they had discovered that someone had built a room under their home to grow cannabis covertly.  They warn about how this could “seriously compromise the integrity of the structure above.”

Apparently it was a pretty successful operation as they found about 100lbs of cannabis ready for distribution and 571 plants under cultivation.

For a copy of the Bulletin you can click here

Bulletin Medical Cannabis Cards Used as Decoy?

DEAAccording to a DEA document (DEA-DCT-BUL-064-15), released under the Freedom of Information Act, they have encountered “medical marijuana” card holders acting as decoys for shipments of cannabis across the border.

According to the bulletin they have had instances of people crossing the border who smelled of Cannabis who claimed Medical Marijuana use.  In the 2 instances cited the people had the smell of marijuana on them that have showed their state issued medical cannabis cards.  In one instance they found a single gram which they confiscated, and in both instances they allowed the persons entry into the country without any charges.

What they fear, but have no documentation it has occurred, is that someone will keep the agents busy while a big load comes across the border.  So as a warning to the agency they are expressing that this could be used as a tactic to bring cannabis into the country.

What a joke the document which was created in 2015 is.