Tag Archives: Cannabinoid

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.

VA releases Medical Cannabis Report

If anyone has been watching the VA website they had a report about the medical use of Cannabis for Pain and PTSD.  The document has not been available for the public but through the power of the Freedom of Information Act we were able to get a copy.

This 124 page, well researched document is probably one of the most extensive looks at Cannabis done by a Government agency.  It not only looks at the use of Cannabis for Pain and PTSD but also looks at the harms of Cannabis use.

While they didn’t find much quality research on the medical use of Cannabis for Pain or PTSD they did find a lot of information.  The research they cite from all kinds of sources indicate that the lack of research is limiting their ability to make quality decisions on Cannabis for Medicine or Safety.

CONCLUSIONS

Although cannabis is increasingly available for medical and recreational use, there is very little methodologically rigorous evidence examining its effects in patients with chronic pain or PTSD. There is limited evidence that cannabis may be helpful in improving pain and spasticity in selected populations with MS, but there is insufficient evidence in other populations. There is insufficient evidence examining the effects of cannabis in PTSD populations. Cannabis is associated with an increased risk of short-term adverse effects, but data on its effects on long- term physical health vary; harms in older patients or those with multiple comorbidities have not been studied. Cannabis has been associated with short-term cognitive impairment and potentially serious mental health adverse effects such as psychotic symptoms, though the absolute risk and application specifically to chronic pain and PTSD populations are uncertain.

You can get the entire document here at this link – Benefits and harms of cannabis in chronic pain or post traumatic stree disorder

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

 

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

 

Mission of the FDA and Cannabis

FDAIs the FDA meeting it’s stated mission?  When it comes to Cannabis, and other medications, it would seem not.

The stated mission of the FDA is:

FDA is responsible for protecting the public health by assuring the safety, efficacy and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation.

FDA is also responsible for advancing the public health by helping to speed innovations that make medicines more effective, safer, and more affordable and by helping the public get the accurate, science-based information they need to use medicines and foods to maintain and improve their health.

FDA also has responsibility for regulating the manufacturing, marketing and distribution of tobacco products to protect the public health and to reduce tobacco use by minors.

FDA also plays a significant role in the Nation’s counterterrorism capability. FDA fulfills this responsibility by ensuring the security of the food supply and by fostering development of medical products to respond to deliberate and naturally emerging public health threats.

Protecting the Public Health by assuring the safety, efficacy of drugs and devices.

When it comes to Cannabis they are not assuring that what is being sold is safe.  It’s been found that the cannabis sold in CO, WA and OR have had issues with mold, heavy metals, and non-organic grown cannabis making it’s way to the market.  If the FDA was doing it’s job it would be demanding the DEA re-schedule cannabis so that they can control production.

fda-otcAdvancing the public health

Again when it comes to Cannabis they are not advancing public health.  In fact they are actually hindering the public health by not allowing it to be monitored or even determining what needs to be monitored.

Speed Innovations that make medications more effective, safer, and more affordable.

Again they are failing.  It’s been well documented that in states where Cannabis medications are allowed the use of other medications have been reduced.  In most instances these medications are not as effective, not as safe or as affordable than Cannabis.  The research that has already been done, showing safety, shows that a variety of products are not being sped to market.

fda-safeHelping the Public get Information they need

They seem ready to promote new drugs made from chemical processes but when it comes to herbal items like Cannabis they fail.  Instead all you really hear from the FDA is when there is a problem with an approved medication.  Even “safe” over the counter medications the FDA is failing to protect the public.

It’s time for the FDA to turn itself around and become the organization it was meant to be.

The first step is to put then FDA in charge of the Controlled Substance Schedules.  Why the DOJ is in charge of what substances are on the various schedules simply doesn’t make sense from any aspect.  Having the DOJ enforce the substance laws makes sense, but why are they the ones to schedule a substance, is it logical?  Wouldn’t it make greater sense for a properly run FDA to be in charge of scheduling substances?  They are supposed to have all the information or are able to research and determine the information for substances that might be used as either a medication or as a food.  Doesn’t that make the FDA the logical people to determine if a substance can be sold and distributed?

The second step would be for the FDA to then approve Cannabis to be sold in the United States under the CSA.  Under the CSA there already is in place a registration process for manufacturers of substances including Cannabis.  It’s how so many pharmaceutical companies, the Mississippi Farm, the University of MN do research.  There is nothing in the CSA that says substances on Schedule I can’t be manufactured, distributed, it simply says there needs to be controled so that it doesn’t end up in the illicit market.  By licensing those, in states that allow it, to register and document what they produced and where it went would allow for recalls and other things that would benefit the consumer.

Let’s face it with 60-65% of the United States saying that we should legalize cannabis it’s time to change the system.  The FDA could make public sales controlled and the products safer for consumers which is what their mission is.

 

Current Therapeutic Cannabis Controversies and Clinical Trial Design Issues

marijuana-001In an article in Front. Pharmacol., 14 September 2016 Ethan Budd Russo the Medical Director of PHYTECS wrote extensively about the “Controversies” and in this article we will summarize some of the most important parts.

Among his many outstanding accomplishments we copy from his BIO

Ethan Russo, MD, is a board-certified neurologist, psychopharmacology researcher, and Medical Director of PHYTECS, a biotechnology company researching and developing innovative approaches targeting the human endocannabinoid system (“ECS”). The PHYTECS team pioneered scientific understanding of how the ECS regulates physiological functions including immunity, pain, inflammation, mood, emotion, learning, memory, metabolism, appetite, weight, sleep, embryo development, neuroprotection and stress responses.

Previously, from 2003-2014, he served as Senior Medical Advisor, study physician and medical monitor to GW Pharmaceuticalslogo for several Phase II and Phase III clinical trials of Sativex® for alleviation of cancer pain unresponsive to optimized opioid treatment, a Phase II study of Sativex to treat spasticity in cerebral palsy in children, various Phase I studies of Sativex drug abuse liability, and its effects on QTc interval and administration to patients with hepatic impairment, and Phase II studies of Epidiolex® for intractable epilepsy in children.

He graduated from the University of Pennsylvania (Psychology) and the University of Massachusetts Medical School, before residencies in Pediatrics in Phoenix, Arizona and in Child and Adult Neurology at the University of Washington in Seattle. He was a clinical neurologist in Missoula, Montana for 20 years in a practice with a strong chronic pain component. In 1995, he pursued a 3-month sabbatical doing ethnobotanical research with the Machiguenga people in Parque Nacional del Manu, Peru. He joined GW as a full-time consultant in 2003.

He has held faculty appointments in Pharmaceutical Sciences at the University of Montana, in Medicine at the University of Washington, and as visiting professor in the Chinese Academy of Sciences and Harvard Medical School.

It can be pretty much said that his creds are above reproach and he isn’t an anti Cannabis researcher, but he isn’t a pro smoking Cannabis supporter either.

In his 20 page report which you can get here he touches on just about everything. He also hold no punches as in his opening comments he states

Finally, the issue of pesticide usage on cannabis crops is addressed. New and disturbing data on pesticide residues in legal cannabis products in Washington State are presented with the observation of an 84.6% contamination rate including potentially neurotoxic and carcinogenic agents.

He does however make a mistake in his statement below.  There is no need for Cannabis to go through any approval process.

s there a pathway that will lead to the return of cannabis to mainstream medicine? The answer is clear, inasmuch as it has already commenced. It follows the same time-honored process that any pharmaceutical must attain to receive regulatory approval: proof of biochemical uniformity and stability along with safety and efficacy as proven by randomized clinical trials (RCT).

Unless sales occur in which case only testing for other issues should be addressed.  Cannabis has already proven itself to be safe, even varieties that produce large amounts of THC and other Cannabinoids. If it wasn’t safe you would see people dying in the streets from overdoses.  They do not even really show up in the Emergency Room, except for paranoia attacks and that has more to do with being worried about being arrested.

While he makes great comments about what would need to happen for Prescription type Cannabis they simply aren’t necessary given the safety of the product.  One thing he does address, not nearly enough emphasis is:

The biochemical variability of one chemovar to another is a primary challenge, while unregulated material may harbor pesticide residues, molds, bacteria, or heavy metals that endanger public health.

There does seem to be some sort of problem with people feeling good.  Not just releiveing a symptom but actually feeling better.  Which frankly seems at odds with all the other medications they shove down people to make them feel better.

In reality, patients are not seeking altered states from their medicine, but rather relief of pain or other complaints. Other cannabis-based medicines that follow will necessarily be required to meet similar benchmarks.

The problem with the current state run systems are a very real and possible source of a problem.

The singular controversy in this category is quality control. Short of a biochemical analysis by a certified laboratory employing verified phytocannabinoids standards, the cannabis consumer can have no real idea of the composition or consistency of the product that they purchase.

Labs that are doing testing may not be competent to test properly

The problem is compounded by the facts that technically almost all laboratories pursuing phytocannabinoid analyses in the USA are doing so illegally, most without benefit of a Schedule I license from the Drug Enforcement Administration (DEA). Additionally, many phytocannabinoid standards available commercially are reportedly suspect. There is additional difficulty in attempting to analyze cannabis confections, as the assays require ascertainment of cannabinoid content from a complex food matrix

He makes perfect sense when he states further in his paper

The author believes that full cannabinoid and terpenoid profiles are necessary for proper decisions by consumers in both the medical and markets

Can Cannabis as a plant be a medicine the Doctor seems to think so.  As he notes other plants have FDA approval and Cannabis has approval in other countries.  Adding:

Botanical medicines can even meet rigorous requirement of the American FDA as has already occurred for one topical agent (Veregen®, an extract of green tea, Camellia sinensis), and one single component botanical isolate taken internally, Fulyzaq® (crofelemer, from Croton lechleri). These approvals were achieved by following a blueprint that was updated in August 2015

FDAHere is a link to the FDA guidelines he speaks about – FDA

While he makes additional good points he misses that for over 10,000 years Cannabis has been used safely so passing any of these tests should be a simple matter.

If components of an extract are not already “Generally Recognized As Safe” (GRAS), clinical trials, safety-extension studies and rigorous quality control requirements all must be met. A botanical agent administered by a non-oral route, such as inhalation, requires additional pharmacology and toxicology documentation before initiation of RCTs.

What about kids?  Won’t they want to smoke Cannabis if they see others? NO according to the Doctors report.

The press frequently criticizes medicinal cannabis on the basis that acquiescence to its availability promotes usage by youth. To the contrary, analyses such as that undertaken by the US Government Accounting Office (GAO) reveal no increase in associated drug crimes or youth usage rates after passage of state laws allowing medicinal cannabis

He Concludes his paper

Conclusions

As the legal tide is turning on cannabis as a forbidden drug, experiments are ongoing in the various states (and other countries) as called for in Justice Brandeis’ “laboratories of democracy.” Daunting problems remain for those attempting to seek regulatory approval for smoked or vaporized cannabis as a prescription product, whereas nabiximols, a standardized oromucosal spray has achieved such approval in 27 nations based on its ability to demonstrate biochemical consistency, and safety and efficacy in randomized controlled trials. Pure CBD (Epidiolex) also appears headed for regulatory approval.

In contrast, the recreational market is facing numerous challenges in quality control, and addressing myriad safety concerns associated with newer, more potent preparations and novel delivery techniques. Science may provide suitable data for addressing these issues if commensurate research funding is forthcoming to meet the urgent need.

you can read the entire article here –

Current Therapeutic Cannabis Controversies and Clinical Trial Design Issues

Ethan B. Russo