Tag Archives: medical cannabis

The Most Misunderstood Plant

Cannabis must be the most misunderstood plant on the face of the planet.  Even among it’s supporters there is a great deal of misunderstanding.

It’s detractors would have you believe that the plant or it’s use is at it’s worst akin to being in league with the devil himself.  Among the many things it is said to have caused is Rape, Murder, Child Abuse, Mental Illness, among a slew of medical ailments.

It’s proponents are generally falling into one of three camps.   Industrial Hemp,  Medical Marijuana, and Recreational Marijuana.  While each of the groups would like to see the other succeed in their actions many times they oppose each other when they shouldn’t be.

The problem comes from a single chemical found in the Cannabis Plant  THC.  THC is the active psychoactive chemical associated with the high that people get from ingesting or smoking the plant or it’s extracts.  THC is a drug that has been made synthetically pure in a pill or liquid form, is FDA approved, and is available from the pharmacy for certain medical conditions.  The DEA doesn’t even really track how much THC is made or used in the US, it’s a low schedule drug.  However when it comes to the plant well it’s a totally different situation.

So what’s the problem.  Hemp proponents would have you believe that Cannabis with a THC content below a certain percentage is “Hemp” and not Marijuana.  They believe that by reducing the THC content of the plant to a point that it isn’t desirable for medical or recreational purposes that they will be able to grow the plant and use if for it’s industrial purposes.  They hope that this will allow the mass cultivation of Cannabis across the United States and world.

While it’s true that Cannabis can be breed to have a low THC content, it’s the fiber and other parts of the plant including the tops that contain the multi-level value that farmers need to succeed with the crop.  Fiber content can be breed into the plant just as THC can be breed out, but no one knows if the fiber is being affected by the concentration on THC content.  Look at it this way, Breeders of plants for cultivation do not look at the chemical makeup of the plant they look at what it is their customers want.  In the case of Cannabis there are customers for all parts of the plant from it’s fiber to it’s various Cannabinoids.

Cannabis is a unique plant.  You can grow Cannabis in a manner similar to how industrial Cannabis is grown and produce not only high quality fiber, hurds, but also the top itself for medical and recreational purposes.  Looking at a field of Cannabis you can not determine if it is low THC Cannabis or High THC Cannabis.  It’s simply not possible.   So the THC content of the field only is important to law enforcement.  This would be absurd if applied to other crops.  There is no evidence that the THC content of Cannabis produces anything better than any other variety of Cannabis.

There is no reason to breed out the THC from Cannabis for the crop to be successful.  Actually the cultivation of large quantities of low THC Cannabis near medical or recreational Cannabis will result in crossbreeding.  This crossbreeding will result in seed stock of each grower that has a THC content different from that of it’s original plants and presents all kinds of problems.

There is no reason, other than political, to regulate the amount of THC that can be produced by a Cannabis plant to determine it’s use.  Cannabis is Cannabis, while there might be varietal differences just as there is with all other crops and plants, doesn’t change the fact that it is still Cannabis.

For government to set an arbitrary limit on the THC content for it to be “Industrial Hemp” is insanity at it’s finest.   For proponents of the use of Cannabis for it’s industrial applications to allow this is even more insane.  It’s not known how THC interacts with the fiber quality, quantity and other factors of the plants ability to survive diseases.  For THC to be used as something that needs to be controlled is simply not going to work in the long run.

It’s time for Industrial Cannabis people to stop hiding behind the word Hemp and make any attempt to discriminate themselves into legalization.  I say this from being an Industrial Hemp Advocate.  For years I focused on it’s industrial applications.  When pushed I said it’s possible to breed out THC and that many countries had, but it wasn’t necessary.  It gave me an opportunity but the opportunity has been used and worked.  I personally talked more about Industrial use than even Medical use.  Now, Cannabis is Cannabis, is Cannabis you simply can’t have one without the other as they are so inter-related that the more we discover the more we may regret allowing low THC Cannabis to be something different than the Medical and Recreationally used Cannabis.

 

 

DEA Information Removed From Site

Back in January ASA filed a suit against the DEA about information that was on the Public Website for the DEA that was faulty.  The DEA removed information from the site.

We were interested in what did the DEA remove from it’s website.  We filed a FOIA request with them and received a response.  In the response it appears the DEA has only removed two documents from it’s website.  The total content of materials removed constitute about 17 pages mostly dealing with Medical Cannabis.

The Documents they released are here at this link 17-00351-F documents

While this is a small victory it could lead to additional victories against other agencies which use essentially the same information on their sites.

If you would like to see the other information we have collected from the DEA and other agencies check this link – DEA FOIA

DEA says Inhaled is Better

Today the DEA announced that they have a new FDA approved form of THC called Syndros.  Syndros is the result of work of Insys Therapeutics to create a new oral THC that has 5mg per ML of solution. – FEDERAL REGISTER LINK

In the DEA’s findings they are planning to schedule this as a Schedule II drug because.

Dronabinol is a generic name for the (-) delta-9-trans isomer of tetrahydrocannabinol (THC). THC is the primary psychoactive substance in marijuana. Dronabinol is the active pharmaceutical ingredient in Syndros. As stated by HHS, Marinol (synthetic dronabinol in sesame oil and encapsulated in a soft gelatin capsule) was approved by the FDA for medical use on May 31, 1985 and placed in schedule II based on its accepted medical use and high abuse potential. On July 2, 1999, Marinol was rescheduled from schedule II to schedule III because of the findings of the DEA that the difficulty of separating dronabinol from the sesame oil formulation and the delayed onset of behavioral effects due to oral route administration supported a lower abuse potential of Marinol as compared to substances in Schedule II. 64 FR 35928.

Going on to state:

HHS indicated that the formulation of Syndros (oral solution) is easier to abuse than Marinol because this liquid formulation can be manipulated to produce concentrated extracts of dronabinol for abuse by inhalation (smoking or vaping) or through other routes of administration. Because of the large amount of dronabinol in Syndros oral solution it has a greater potential for extraction than Marinol and thus has a greater abuse potential.

Based on the use of Cannabis by the general public DEA feels that this form of THC needs to be a Schedule II drug.

What you find when reading further down is that it appears DEA would rather people smoke it because of the onset of effects are easier to control.

Oral consumption of dronabinol, compared to inhaled THC, may result in psychoactive effects that are delayed and stronger with an increased risk of experiencing serious adverse events.

But then they quickly add:

When dronabinol (THC) is smoked, the drug rapidly reaches the brain and psychoactive effects are felt within minutes of inhalation, which allows the subject to control the dose more readily.

The DEA is full of contradictory things but this just about takes the cake.  Using a substance via oral methods pose issues that smoking or inhalation don’t and is better at controlling the dose.  However they are afraid that people will do just that.  Take this new drug and turn it into something they can control the dose better.

There is a time that this potential rule can be commented on, see the link at the top of the page to the federal register.

Congressional Research Service Report on Cannabis

On March 10th the Congressional Research Service released it’s report on “The Marijuana Policy Gap and the Path Forward”

“Given the current marijuana policy gap between the federal government and many of the states, there are a number of issues that Congress may address. These include, but are not limited to, issues surrounding availability of financial services for marijuana businesses, federal tax treatment, oversight of federal law enforcement, allowance of states to implement medical marijuana laws and involvement of federal health care workers, and consideration of marijuana as a Schedule I drug under the CSA. The marijuana policy gap has widened each year for some time. It has only been a few years since states began to legalize recreational marijuana, but over 20 years since they began to legalize medical marijuana. In addressing state – level legalization efforts and considering marijuana’s current placement on Schedule I, Congress could take one of several routes. It could elect to take no action, thereby upholding the federal government’s current marijuana policy. It may also decide that the CSA must be enforced in states and not allow them to implement conflicting laws on marijuana. Alternatively, Congress could choose to reevaluate marijuana’s placement as a Schedule I controlled substance.”

Here is the document – R44782

And a link to the CRS report

DEA/DOJ not the Problem

I’m sorry but the DEA/DOJ are not the problem with Cannabis legalization on a federal level or even Scheduling of Cannabis.  The real problem is with HHS, FDA, NIDA and other “Medical” organizations that continue to feed DEA/DOJ faulty information.

While I’m not going to say that the DEA doesn’t want to have Cannabis in Schedule I for ease of prosecution, they are not to blame for failed Petitions.  The problem is in the petition process.  First the DEA is required to ask the FDA, NIH for a recommendation.  Well they both ask NIDA to give them the information and everyone knows that NIDA is opposed to Cannabis.

NIDA provides FDA and NIH with information about Cannabis and all it’s “Hazards”.  Rather than do a real investigation like it’s own PubMed and other resources it barfs up NIDA information and gives it to the DEA.

DEA then takes that information and says sorry not going to change anything.

There is also the fact that the petitions in the past 6-7 years have been faulty in their filing and haven’t been really challenged in court.

HIA has offered DEA resistance and met with success.  ASA is currently suing the DEA for it’s compliance with the little known “INFORMATION QUALITY ACT”.  This requires agencies to provide Quality Information when they give it out.  Frankly NIH, NIDA and any other agency that has information opposing Cannabis should be challenged.

If your not following on social media NIH, FDA, and NIDA then you should be:

FDA https://www.facebook.com/FDA/

NIDA https://www.facebook.com/NIDANIH/

NIH https://www.facebook.com/nih.gov/

USDA https://www.facebook.com/USDA/

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