Tag Archives: cannabis use

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

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.

 

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.

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.