Monthly Archives: September 2016

Does Cannabis Use Equal Abuse?

As we have searched through various databases about Cannabis a consistent theme has developed.  Use = Abuse when it comes to Cannabis.

This just doesn’t make any sense.  Just because something is used doesn’t mean it’s abused.  Unfortunately because of state and federal laws, Use = Abuse.  At least that is what it looks like when you look at NIDA and other cannabis studies on use.

It also appears in many law cases.  The accused is said to have a cannabis use disorder.  What is a Cannabis Use Disorder?  Meaning the person violated the state or federal law that Cannabis is a schedule substance and not legal to buy like you can alcohol or tobacco?

Dr. Damon concluded that defendant suffers from … mild cannabis use disorder in a controlled environment, and antisocial personality disorder.

apaAccording to the DSM 5th revision Cannabis Use Disorder is described as

Cannabis use disorder or cannabis dependence is defined in the fifth revision of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) as the continued use of cannabis despite clinically significant impairment, ranging from mild to severe.

So Use Disorder, which sounds really bad, is actually not.   “continued use of cannabis despite clinically significant impairment”.  Not DESPITE clinically significant impairment.  So simply using Cannabis is all it takes to get this “Disorder”.  But if there is no impairment how can there be a disorder?  That remains to be understood.

Cannabis, Safe & Effective

There are a lot of studies that have been completed and many more that are awaiting start.  You can find studies on what cannabis at ClinicalTrial.Gov and search for Cannabis – Marijuana – Cannabinoids and other terms and come up with all kinds of results.

fedregWhere you can really find heads up is the Federal Register.  There you will find people that are applying to obtain licenses from the DEA to handle Cannabis (search for 7360 the DEA code for Marijuana).  When they apply under law there is a comment period where persons, organizations and companies can make comment on the application.  Most of the time there is no comment made and then the DEA decides if they are going to grant or not. However if there are comments made then the DEA incorporates these comments into their reply to the application when they grant or deny.

nih1Finally there is also PubMed where you can search all kinds of different things.  You will find information like this from  Medical Marijuana: Just the Beginning of a Long, Strange Trip? C.D. Ciccone, PT, PhD, FAPTA, Department of Physical Therapy, Ithaca College.

Although there is still a need for randomized controlled clinical trials, preliminary studies have suggested that medical marijuana and related cannabinoids may be beneficial in treating chronic pain, inflammation, spasticity, and other conditions seen commonly in physical therapist practice. Physical therapists should therefore be aware of the options that are available for patients considering medical marijuana, and be ready to provide information for these patients. Clinicians should also be aware that marijuana can produce untoward effects on cognition, coordination, balance, and cardiovascular and pulmonary function, and be vigilant for any problems that may arise if patients are using cannabinoids during physical rehabilitation.

So it’s clear from the information available that THC, Cannabidiol along with all of the other cannabinoids and substances in Plant based Cannabis

  •  does not produce any unknown adverse effects or other effects that are extremely common in Pharmaceutical preparations.
  •  does not have an unattainable LD-50 level (another indicator of overall safety).
  • has shown therapeutic actions that are beneficial to many patients.

So there is no reason why companies should need to rely on synthetic versions of the various cannabinoid and plant compounds.  They should be allowed to use the whole plant and the various strains of the plant to treat any condition.

Given the safety of the substances, the variety of administration methods there is no reason not to use trial and error.  As has been seen with Charlotte’s Web there are strains that work better for some conditions.  As the science of cannabis expands so will the introduction of strain specific treatments.  There isn’t a reason to not be able to move from one concentration of substances to another just like doctors change medications that aren’t producing the desired results to ones that do work.

Not every medication works for every person.  It happens all the time in medicine, a doctor prescribes something and it just doesn’t work or produce the desired effect.  Change drugs to something similar and bingo it works.  Doctors can’t explain it, Pharmacy companies can’t explain it, the FDA can’t explain it.  Given the great number of varieties already developed and those that will be developed that lots of conditions can be treated with cannabis.

Cannabis has a long history of being safe and effective.  There is no reason that all cannabis can’t be used by patients because of this safety when used.  Unlike other medications that can produce irreversible affects, cannabis just doesn’t do that to patients.

Price of Big Pharm Cannabis

It’s pretty clear with the recent developments that Big Pharm is seriously looking at Cannabinoids.logo  hgDPF-j4_400x400While the vast majority like GW Pharm are using synthetic versions there are plant derived cannabinoids and the plant itself being used in clinical studies.

The cost of Synthetic Cannabinoids is easy to determine.  Sigma-Aldrich offers Cannabinol for $25 a milligram.  A single milligram of THC costs almost $50.  Cannabidiol is also nearly $50 a milligram.  Synthetic Cannabinoid medications are going to be expensive.  Given that a dose of 10mg THC – <1mg CBD needed for pain the cost per dose is going to be over $500.

marijuana-001Plant based medications are in comparison cheap.  Even at the expensive distributors in a very restrictive state like MN you can get 100mg of THC and 4mg of CBD for only $47.00 .  This comes down to $4.70 per effective dose. Clearly plant based extracts of Cannabinoids are cheaper than synthetically produced ones.

Big Pharmacy seems to be interested in making Cannabinoids but will the public be able to afford what they synthetically produce?  Not at $500+ a dose

 

Effects of Vaporized Marijuana

clinicalWhat are the affects of Effects of Vaporized Marijuana?  Are there any adverse events?  How about Serious adverse events? According to a small study done at the University of California, Davis with the collaboration of the Center for Medicinal Cannabis Research, VA Northern California Health Care System, nope.

In a study on Effects of Vaporized Marijuana on Neuropathic Pain they not only found that a significant number of participants benefited with lower pain levels, they also reported No Events of any significance.  The study included what they call low (1.29% THC) and medium (3.53%) and a placebo.

Surprisingly this study has been sitting on ClinicalTrials.gov since it’s completion in 2013

Here is a link to the study – ClinicalTrials.gov NCT01037088

 

USP Door For Cannabis?

uspThere are a number of ways that Cannabis could be recognized as a medical substance or at least treated differently than it is now.  One is the DEA, well we already know how helpful they are.  Another would be the FDA, they already supply the misinformation used by the DEA so are they an option?  Maybe.  The other is to get something back into the Formulary through the USP.

The USP has legal authority given to it by the FDA back in 1966:

The U.S. Federal Food, Drug, and Cosmetics Act designates the USP–NF as official compendia for drugs marketed in the United States. A drug product in the U.S. market must conform to the standards in USP–NF to avoid possible charges of adulteration and misbranding.

Could the USP be a door for Medical Cannabis?  The USP (United States Pharmacopeia) is one of several formularies used by Health Care Practitioners and the FDA to determine medical value of substances and plants.

What most people don’t know is that while the USP creates monographs for chemicals they do the same for Food Ingredients and Dietary Supplements.  Again with legal authority given to them by the FDA

Currently, over 200 FDA regulations cited in the U.S. Code of Federal Regulations incorporate the food ingredient standards that USP publishes in the Food Chemicals Codex (FCC) compendium. The first edition of the FCC, which was published in 1966 by the Institutes of Medicine, was given quasi-legal recognition in July 1966 by means of a letter of endorsement from FDA Commissioner James L. Goddard, which was reprinted in the book. The letter stated that “the FDA will regard the specifications in the Food Chemicals Codex as defining an ‘appropriate food grade’ within the meaning of Sec. 121.101(b)(3) and Sec. 121.1000(a)(2) of the food additive regulations, subject to the following qualification: this endorsement is not construed to exempt any food chemical appearing in the Food Chemicals Codex from compliance with requirements of Acts of Congress or with regulations and rulings issued by the Food and Drug Administration under authority of such Acts.”

and

USP’s standards for dietary supplements may be found in USP–NF and Food Chemicals Codex (FCC) compendia. Legal recognition varies depending from which compendia the standards are published.

To do this the USP works with manufacturers to develop monographs for items:

USP develops public standards to provide quality oversight for dietary supplements and their ingredients. Public input and interaction are vital to the development of these standards, which originate from the draft monographs and data provided by dietary supplement manufacturers, users, and suppliers. USP’s scientific staff and the volunteer Dietary Supplements Expert Committee review data, conduct necessary laboratory tests, and ensure that the information is subject to a process of public review and comment.

They do this through several public forums which they operate:

Proposals for new or revised dietary standards from USP–NF and FCC that appear in the DSC are first published for public review and comment in either the Pharmacopeial Forum or the FCC Forum. Through these free online forums, interested parties have the ability to provide feedback on the proposed standards and revisions and participate in the USP standards-setting process.

They encourage people to submit their substances for inclusion:

USP encourages you to submit draft monographs for the dietary supplements you manufacture or supply. Your draft monograph will become the starting point for the public standard. USP staff will involve you in the public process of review and comment to refine and finalize the monograph for publication in the next USP-NF edition or supplement.

The USP sounds like it is an avenue that is open to Medical Cannabis in the form of a Food Ingredient or as a Dietary Supplement and they tell you how to do it.

USP wants Medical Cannabis Experts

uspLooking deeper into the USP and what they might be doing with Medical Cannabis we run across that they are looking for Experts to sit on a panel.

Posted Aug 30th on their website they are seeking qualified candidates to sit on a panel to “develop quality standards for cannabis used for medical purposes.”

That expert panel will then make recommendations to the Botanical Dietary Supplements and Herbal Medicines Expert Committee.

They expect to have this panel in place by the end of Sept 2016

“Expert panels are formed to provide additional expertise on a particular compendial topic, thereby supplementing Expert Committee expertise. Each Expert Panel has a specific charge (including scope of work, deliverables, and timeline for completion) and will be dissolved at the conclusion of its work. Expert Panels are advisory to one or more Expert Committees; they are not decision-making bodies.”

A person can apply to be on the expert panel at the following link –  USP

For additional information, contact Nandakumara Sarma, Director, Herbal Medicines (dns@usp.org or 301-816-8354).

US Pharmacopeia looking at Medical Cannabis

uspFollowing up on why would the USP want to be registered with the DEA we found, The US Pharmacopeia is looking at medical Cannabis and how to set a Monograph.  This is extremely important for anyone seeking to get FDA approval and DEA to re-schedule.

Based on what we have found in the USP website it’s clear that they are aware that Cannabis has a long history of medical use. “In 1850, USP admitted cannabis as a recognized drug in the United States Pharmacopeia (USP) and published an Extractum Cannabis (or Extract of Hemp) monograph”

usp-mjIt’s also pretty clear that they can develop standards for Cannabis products.  “USP has a long history of developing quality standards for herbal medicines, either as pharmaceuticals or as dietary supplements. USP has state-of-the-art laboratories throughout the world, and global scientific expertise in the form of USP staff and expert volunteers. This cumulative experience and expertise at USP could be used as a foundation for standard development for cannabis products.”  adding  “USP is considering organizing an open forum for discussion of these proposals to gather input for a suitable path forward toward the potential development of quality standards for medical cannabis.”

However they fear the results without working closely with the FDA and DEA.  “Another important consideration would be where to publish the standards that USP may develop for medical cannabis. USP’s flagship compendia, the USP–NF, are recognized as “official compendia” under United States law and contain standards for identity, strength, quality, and purity of medicines that are enforceable by the FDA. Generally, USP–NF only contains monographs for drugs that were included in USP before the 1938 amendment to the Food, Drug and Cosmetic Act, or drugs that are legally marketed in the U.S., which presents an important challenge given that marijuana is currently illegal under federal law. Given medical cannabis’ current legal status, the regulatory implications of publishing cannabis standards in USP–NF would need to be carefully reviewed and analyzed with input from regulators and other stakeholders. In particular, input from the FDA and U.S. Drug Enforcement Administration will be critical.”

USP is clearly looking at Medical Cannabis and how they might control or help it’s regulation and use.  “As the use of medical cannabis is growing, the need for a USP public scientific standard to help ensure identity, purity, quality, and strength has been identified. Public quality standards for medical cannabis are important for many reasons, including the avoidance of adulteration, accurate identification, control of contaminants, and considerations regarding constituent composition and strength.”

Concluding “USP is committed to working with stakeholders to determine the advisability and feasibility of developing public quality standards for medical cannabis. USP welcomes comments on the issues and ideas presented in this Stimuli article and on all aspects of developing such standards, including scientific and public health considerations, legal and regulatory issues, and mechanisms for obtaining appropriate scientific expertise and ongoing stakeholder input.”

USP recognizing medical cannabis would help change DEA scheduling of Cannabis.  For more information and link to the Article they published follow here – LINK

The USP recently filed an application with the DEA to deal with Cannabis a schedule I substance.

Pharmaceutical Companies Want Marijuana?

Fed-RegIf you look at the Federal Register there was a big bump in Pharmaceutical companies filing applications to manufacture and import Marijuana in August and September.

After the DEA’s announcement that it is going to allow more Cannabis to be produced for researchers, a number of Pharmaceutical companies are renewing or filing new applications.  hgDPF-j4_400x400Companies like Sigma-Aldrich and US Pharmacopeial Convention* are wanting to be importers, others like Insys and AMRI Renselaer want to be bulk manufacturers.

Most all of them are asking to work with Synthetic Marijuana which begs the question what is Synthetic Marijuana?  Many times this means they are working with cannabinoids that are made in a lab vs grown on Cannabis, which begs the question why then do they want their application to read Bulk Manufacturer of Marijuana?

wss_skunk_cured_budThere simply doesn’t seem to be a need to register to manufacture Marijuana when all your working with is one of the Cannabinoids.  All Controlled Substances have an id number, for Marijuana it’s 7360, for THC it’s 7370.  If your working with THC you only need registration for THC, other cannabinoids also have ID numbers.

With the re-registration or new applications all suddenly being submitted by all these companies at the same time raises a red flag.  Certainly not all of them are due at the same time each year, generally applications are an annual thing.  So why all of a sudden the application filings?

Interesting thing about Pharmaceutical Companies is they generally do not get registered for things they are not working on.  So what are they working on in private?  No one knows.

 

*The United States Pharmacopeia is a pharmacopeia for the United States published annually by the United States Pharmacopoeial Convention

Prof at U of Miss has Medical Cannabis

For those that don’t know the University of Mississippi grows cannabis for medical experiments.  What exactly they grow, and what they process isn’t totally known but a little bit has been leaked by the Prof in charge himself.

Prof ElSohly has been growing cannabis since 1975 under contract with NIDA, FDA and the DEA.  Under his contract he produces Medical Grade cannabis products.  Apparently he grows a number of varieties, makes a number of different products all of which are designed to be used for Medical purposes.

In a Rare appearance before a Justice Summit he explained the problems with Medical Cannabis and how he solved them.  The presentation he gives is long and is extremely detailed about the various cannabinoids and terpenes that are found in Cannabis and how they already know what some of them do.

A1The interesting part is his explaining how they grow and process their cannabis to make medical products for others to test and use.  First they do not rely on seed they, like most growers, they clone plants and then put them outside to finish growing.  On their 18 acre facility they grow and produce all the medical grade cannabis legally available in the United States.

As you watch the video below you will see how he describes in detail how they process cannabis they grow and produce medical grade cannabis.  All that remains to be done with his work is to get it FDA approved.

FDA approval requires a number of things, all of which Prof ElSohly has done.  He, and his team, grow under controlled conditions and produce medical grade cannabis by following the rules of manufacture and processing.  Thus he produces true medical grade cannabis.

 

 

DEA Allow New Cannabis Manufacturers? Not Likely

DEADespite the DEA saying that they are open to allowing new manufacturers of Cannabis, it’s not likely to happen anytime soon.

First is the requirements for security.  Please see the DEA diversion control manual used to evaluate Controlled Substance manufacturers we obtained through FOIA – Link –  While they can be obtained as the U of Miss is an example of what’s necessary, however it will be expensive.

Next of course is the application process.  First you need to complete the application online with the DEA and pay your application fee.  This is not a registration fee this is an application fee and is non-refundable if your not registered.  Here is a link to the DEA application process. – LINK TO DEA

Then comes publication in the Federal Register.  This allows those who are already involved a chance to comment on your application.  While it is rare for there to be comments on a manufacturer it is likely that anything of any substance will be scrutinized by all parties.

 

There is also a problem with the fact that the U of Miss has untapped cultivation potential.  The U of Miss only grows cannabis once ever couple of years.  Even then they only use a small portion of their 18 acre site.  It’s probably more likely to get support if someone works with the University and rents it’s facility.

There are any number of reasons why the DEA can deny a permit to cultivate Cannabis and anyone who applies is likely to face all of them.