Tag Archives: Cannabis Studies

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

World Health Organization to Review Cannabis

It is going largely unknown, unreported and ignored that the World Health Organization (WHO) the arm of the UN that controls the schedule of substances is looking at Cannabis.

As part of the UN the US and the FDA is looking for input from people and organizations about the changes and surprisingly no one is commenting.  The comment period ends Feb 10th at midnight eastern time and so far they have gotten 3 comments.

https://www.regulations.gov/docket?D=FDA-2016-N-4619

3 comments, that is really pretty sad considering a change in the scheduling of Cannabis on an international level could lead to changes in scheduling on a federal level here in the US.

The United States is also a party to the 1961 Single Convention on Narcotic Drugs (1961 Single Convention). The Secretary of State has received a notification from the Secretary-General regarding two substances to be considered for control under this convention. The CSA does not require HHS to publish a summary of such information in the Federal Register. Nevertheless, in an effort to provide interested and affected persons an opportunity to submit comments regarding the WHO recommendations for narcotic drugs, the notification regarding these substances is also included in this Federal Register notice. The comments will be shared with other relevant Agencies to assist the Secretary of State in formulating the position of the United States on the control of these substances. The HHS recommendations are not binding on the representative of the United States in discussions and negotiations relating to the proposal regarding control of substances under the 1961 Single Convention.

Of the substances being considered

The Committee recommended that a specific ECDD meeting dedicated to cannabis and its component substances should be held within the next eighteen months from the 38th meeting, and will carry out pre-reviews for the following substances:

—Cannabis plant and cannabis resin;

—Extracts and tinctures of cannabis;

—Delta-9-tetrahydrocannabinol (THC);

—Cannabidiol (CBD);

—Stereoisomers of THC.

The recommendations and the assessments and findings on which they are based are set out in detail in the Report of the 38th Expert Committee on Drug Dependence, which is the Committee that advises me on these issues. An extract of the Committee’s Report is attached in Annex 1 to this letter.

 

Here is a copy of the WHO Review Report – WHO-cannabis-report

 

 

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

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/

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

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.