Monday, January 29, 2018

Accredited Medical Cannabis Education Resources

Resources for Medical Patients, Professionals, and Researchers

The medicinal properties of cannabis are varied given the multiplicity of physiological roles of the endocannabinoid system, a ubiquitous molecular signaling system at which compounds in cannabis have robust receptor-based actions. Here is information on medical cannabis practice policies and procedures, as well as scientific and practice ethics information.

In This Section ( Highlighted Embedded Links Go To Educational Materials )

PFC Brochure

Introducing ASA's independent certification program for medical cannabis industries, Patient Focused Certification

AHPA Industry Standards

Founded in 1982, AHPA is the oldest of the non-profit organizations that specializes in service to the herbal industry. It is the voice of the herbal products industry and the recognized leader in representing the botanical trade. With more than 300 members, AHPA's membership represents the finest growers, processors, manufacturers, and marketers of botanical and herbal products.

Guide to Regulating Industry Standards

ASA has created the Patients Focused Certification (PFC) program. PFC is a non-profit, third party certification program for the medical cannabis industry and the nation’s only certification program for the AHPA and AHP standards. PFC is available to all qualifying companies cultivating, manufacturing, or distributing medical cannabis products, as well as to laboratories providing medical cannabis analytic services. PFC offers a comprehensive program that includes employee training, compliance inspections, ongoing monitoring, regulatory updates and an independent complaint process for consumers.

Scientific History of Medical Cannabis

Cannabis was a part of the American pharmacopoeia until 1942 and is currently available by prescription in the Netherlands, Canada, Spain, and Israel in its whole plant form...
Cannabis Safety

One of marijuana's greatest advantages as a medicine is its remarkable safety. It has little effect on major physiological functions. There is no known case of a lethal overdose; on the basis of animal models, the ratio of lethal to effective dose is estimated as 40,000 to 1.

Medical Cannabis Research

Cannabis has immense medical value; we have collected research on cannabinoids and the therapeutic use of cannabis.

Condition-based booklets

In-depth information on the use of cannabis to treat HIV/AIDS, Multiple Sclerosis, Arthritis, Gastro-Intestinal Disorders, Movement Disorders, Cancer, Chronic Pain, and issues associated with Aging.

State-by-State: Recommending Cannabis

State-specific laws that pertain to medical cannabis for medical professionals.

Physician’s code of Ethics and Medical Marijuana

Excerpted from the AMA’s current opinions on the physician’s code of ethics

The Answer Page

One stop shopping for quality CME credits on medical marijuana. This content is jointly sponsored by the Massachusetts Medical Society and The Answer Page and approved for AMA PRA Category 1 Credits.™

Medical Marijuana Access in The U.S.

ASA is proud to announce the 2017 release of our report analyzing and comparing medical cannabis programs across 45 jurisdictions.

Medical Cannabis in America- The Medical Cannabis Briefing Book, 115th Congress

This briefing book is intended for the members of the 115th Congress and the President of the United States to help them make informed decisions on medical cannabis policy.

Medical Cannabis Access for Pain Treatment

Americans for Safe Access (ASA) has created this document to educate and inform legislators and regulators of the growing need for an alternate treatment for the millions of patients suffering from pain every day.

Patient Cultivation

Medical cannabis patients need patient cultivation for a variety of reasons. This report explains why.

About Americans for Safe Access

The mission of Americans for Safe Access (ASA) is to ensure safe and legal access to cannabis (marijuana) for therapeutic use and research.

ASA was founded in 2002, by medical cannabis patient Steph Sherer, as a vehicle for patients to advocate for the acceptance of cannabis as medicine. With over 100,000 active members in all 50 states, ASA is the largest national member-based organization of patients, medical professionals, scientists and concerned citizens promoting safe and legal access to cannabis for therapeutic use and research. ASA works to overcome political, social and legal barriers by creating policies that improve access to medical cannabis for patients and researchers through legislation, education, litigation, research, grassroots empowerment, advocacy and services for patients, governments, medical professionals, and medical cannabis providers.

Ensuring safe and legal access to cannabis means:

International, federal and state laws and regulations recognized cannabis as a legal medicine.

Medical professionals recommend medical cannabis options as a frontline treatment option or an adjunct therapy.

Patients and their caregivers have the information they need to make educated choices about medical cannabis therapies.

Patients and medical professionals can incorporate a diverse group of products and delivery methods to create required personalized treatment regimen.

Patients can trust labels on products and that medicines are free of pesticides and contaminates.

Medical cannabis treatments are covered by insurance.

Become a part of history! Join us today.


ASA and our members have moved public policy forward by incorporating strategies across many disciplines. ASA has brought together policy experts, public health experts, attorneys, lobbyists, scientists, industry associations and medical professionals to create the campaigns, projects and programs that have broken down political, social, academic, and legal barriers across the US.

ASA occupies a seat at the table for medical cannabis patients in policy matters.

ASA changed the national dialogue about medical cannabis.

ASA created a global patient network.

ASA has passed local, state, and federal laws.

ASA has fought and won in state and federal courts.

ASA has provided quality legal and medical education for medical cannabis stakeholders.

ASA brought cannabis back into the Herbal Pharmacopeia.

ASA has created product safety standards for medical cannabis products.

ASA has built the worlds first International Cannabis and Cannabinoid Institute.

ASA has trained thousands of patient advocates on civil engagement.

ASA has created accredited education programs for doctors, patients, and providers.

Everyday ASA staff are on the frontline of the medical cannabis movement working with our members to shape policy and public opinion moving toward our goals. By participating in this movement, you are helping create the future of medical cannabis in your city, state, and nation. By donating to ASA, you can help ensure that we will reach our goals! Until there’s safe access, we are Americans for Safe Access.
Welcome to the movement.
National Office

1624 U Street NW
Suite 200
Washington, D.C. 20009
Phone: (202) 857-4272
Fax: (202) 618-6977


The American Cannabis Nurses Association (ACNA) is a national organization dedicated to expanding the knowledge base of endo-cannabinoid therapeutics among nurses. It was founded by a small group of dedicated nurses who saw the need for an organization to bring nurses together in a collegial and informational capacity to discuss the growing use of cannabis in medicine.

The American Cannabis Nurses Association (ACNA) and TMCI Global have collaborated to develop the first comprehensive online medical cannabis curriculum for nurses. Topics include the Endocannabinoid System, Dosing, Psychiatry, Medical Risks and Legal Implications. The curriculum features 12 lessons from 11 different authors.

To access the three medical cannabis modules in PDF format please follow these links: Medical Cannabis: An Introduction to the Biochemistry & Pharmacology, Medical Cannabis: Evidence on Efficacy, and Medical Cannabis: Adverse Effects and Drug Interaction.

The Medical Cannabis Institute - Offering a large variety of courses including many presentations from the National Clinical Conferences on Cannabis Therapeutics sponsored by Patients Out of Time

Medicinal Cannabis and Chronic Pain Project - A project of the University of Washington Alcohol & Drug Abuse Institute -’s goal is to create a positive and supportive community of like-minded medical cannabis users. We aspire to be your transparent, trusted source of cannabis information, a respected authority on its safe and smart use. Dustin Sulak, D.O. is a renowned integrative medicine physician based in Maine, whose practice balances the principles of osteopathy, mind-body medicine and medical cannabis. Regarded as an expert on medical cannabis nationally, Dr. Sulak educates medical providers and patients on its clinical use, while continuing to explore the therapeutic potential of this ancient yet emerging medicine.

American Cannabis Nurses Association
10200 West 44th Avenue Suite 304

Wheat Ridge, CO 80033
Phone: 720-881-6047


Want to be a Research Participant?
The MCRF is currently seeking research participants for the following research studies:
Project Title: The Impact of the New Mexico Medical Cannabis Program among People with Chronic Debilitating Health Conditions

Principle Investigator: Jacob M. Vigil, PhD

Specific Requirements: Current enrollment as a patient in the New Mexico Medical Cannabis Program.

Contact: Dr. Jacob Vigil; E-mail

Web Link:

The Releaf App

Releaf is a patent pending app that enables you to track your live sessions with cannabis and record exactly how it’s helping you. It can then provide intelligent reporting to help you learn what types of cannabis and intake methods are working best in treating your symptoms. Share these reports with doctors and/or budtenders to discuss your treatment and identify your best options.

Web Link to download:

Friday, January 26, 2018

Developing a Roadside Test For Cannabis Intoxication Isn't As Easy As It Sounds

As the movement to legalize cannabis in the United States gains momentum, researchers worry about keeping the public safe, particularly on the roads. Recent studies in which cannabis users took controlled doses of cannabis in the lab have identified new biomarkers that can be used to estimate a person's recent cannabinoid intake. But, using those markers to judge cognitive and behavioral impairment is complex, say toxicologists in a commentary published on January 25 in a special issue of the journal Trends in Molecular Medicine on biomarkers of substance abuse.

"There is no one blood or oral fluid concentration that can differentiate impaired and not impaired," says Marilyn Huestis, who spent over 20 years leading cannabinoid-related research projects at the National Institute on Drug Abuse. "It's not like we need to say, 'Oh, let's do some more research and give you an answer.' We already know. We've done the research."

Alcohol can impair a user more than cannabis, and indeed, the risk of an accident while driving increases in proportion with blood alcohol concentrations. But cannabis is different: many variables can affect how impaired someone is at any given concentration of ∆9-tetrahydrocannabinol (THC), the primary psychoactive agent in cannabinoids. Whether it is inhaled or consumed, or whether the user titrates their own dose, can affect the level of impairment. And pairing cannabis with alcohol makes the high higher, and the alcohol buzz last longer.

Another problem is that THC quickly leaves the bloodstream. Previous research by Huestis has shown that while an occasional user is impaired for 6 to 8 hours, blood THC concentrations can be effectively zero after 2.5 hours. And on average in the United States, it takes from 1.4-4 hours after a crash or traffic stop to administer a blood test. "If someone is driving impaired, by the time you get their blood sample, you've lost 90% or more of the drug. So, we have to change what we do at the roadside," says Huestis.

Long-term daily cannabis users, like those who use cannabis for medical reasons, also present a challenge for developing roadside protocols. THC accumulates in the tissues of the body and then slowly releases over time, meaning that chronic users can test positive for cannabis even after 30 days of abstinence. Psychomotor impairment can be observed three weeks after the last dose. "You want people to be taking medicinal cannabinoids and now you know that their driving is going to be impacted," says Huestis. "So how do you handle that problem?"

Huestis, like most researchers, doesn't support a legal driving limit for cannabis like the one in place for blood alcohol concentrations. Instead, she advocates for well-trained police officers who can identify the behavioral signs of impairment and less invasive biological marker tests, which could be immediately performed at the roadside to confirm the presence of a cannabinoid. To that end, recent research has identified new blood and urine markers, and tests using breath and saliva markers are being developed.

The implications go beyond driving. These new markers and tests could also be used to assist in treating drug dependence, in determining appropriate therapeutic levels of medical cannabis, and for monitoring women who want to stop using cannabinoids during pregnancy.

Huestis, who also owns a toxicology consulting company with her co-author, Michael Smith, isn't opposed to legalization. But she does want to make sure that cannabis's status as a legal drug and a medicine doesn't make us complacent. "Cannabis probably is less dangerous to use than alcohol," she says. "There's less morbidity and mortality associated with it, but there's still a lot of problems. And we as a public are not recognizing this."

The Intramural Research Program of the National Institute on Drug Abuse, and the National Institutes of Health funded this research.

Trends in Molecular Medicine, Huestis and Smith: "Cannabinoid Markers in Biological Fluids and Tissues: Revealing Intake"

Trends in Molecular Medicine (@TrendsMolecMed), published by Cell Press, is a monthly review journal that facilitates communication between groups of highly trained professionals who share the common goal of understanding and explaining the molecular basis of disease as it relates to new clinical practice.


Medical Cannabis Benefits: Treating Fibromyalgia

Although fibromyalgia is often considered an arthritis-related condition, it is not truly a form of arthritis (a disease of the joints) because it does not cause inflammation or damage to the joints, muscles, or other tissues. Like arthritis, however, fibromyalgia can cause significant pain and fatigue, and it can interfere with a person’s ability to carry on daily activities. Also like arthritis, fibromyalgia is considered a rheumatic condition, a medical condition that impairs the joints and/or soft tissues and causes chronic pain.

Fibromyalgia is a disorder characterized by intense musculoskeletal pain that affects 5 million Americans. Studies have shown marijuana effectively lowers pain levels and improves quality of sleep in patients.

About Fibromyalgia:

Fibromyalgia is a common disorder characterized by widespread pain and fatigue that primarily affects women. The disorder can greatly affect a person’s abilities to perform daily activities and causes sleep problems. According to Mayo Clinic, having fibromyalgia affects the way the brain processes pain signals and makes painful sensations feel amplified.

In addition to pain, fatigue and sleep problems, those with fibromyalgia may also experience cognitive and memory problems, headaches, morning stiffness, painful menstrual periods, numbness or tingling, restless legs syndrome, temperature to sensitivity, irritable bowel syndrome, and depression.

The causes of fibromyalgia remain unknown, but the National Institute of Arthritis and Musculoskeletal and Skin Diseases notes that many people associate their fibromyalgia to a physically or emotionally stressful or traumatic event. Repetitive injuries or illnesses are also commonly associated to fibromyalgia by patients. Others claim the disorder developed spontaneously.

There is no cure of fibromyalgia, so treatment focus is on controlling symptoms with pain relievers, antidepressants, exercise and therapy.

Most common symptoms of fibromyalgia are:
Diffuse tenderness – sensitive to touch or pressure
Sleep disturbances and unrefreshed sleep
Exhaustion and fatigue
Brain fog – problems with thinking or memory
Mood problems like depression / anxiety

Additionally, many fibro patients also suffer with:
Digestive problems like IBS and GERD
Irritable or overactive bladder
Pelvic pain
Temporomandibular joint disorder (TMJ)

Fibromyalgia can occur in men or women, but is most common in women. Symptoms most often appear as a young adult, but onset can happen at any age.


The cannabinoids contained in cannabis have both analgesic and sleep-promoting effects to help fibromyalgia patients manage symptoms. Studies have found that cannabis is effective at improving sleep disruption, pain, depression, joint stiffness, anxiety, physical function and quality of life in individuals with fibromyalgia (de Souza Nascimento, et al., 2013) (Russo, 2004).

While fibromyalgia is known for causing intense and unrelenting musculoskeletal pain, cannabis has proven effective at offering fibromyalgia patients relief. Fibromyalgia patients treated with cannabis and assessed over a seven-month period experienced significant pain intensity improvements and were able to reduce their doses of opioids (Weber, et al., 2009). One study discovered that after four weeks of cannabis treatment, fibromyalgia patients experienced significantly less pain and anxiety whereas a placebo group saw no improvements (Skrabek, Galimova, Ethans & Perry, 2008). Another study reported significant reductions in pain and stiffness, an enhancement of relaxation and an increase in somnolence and feeling of well being in fibromyalgia patients two hours after they smoked or orally consumed cannabis (Fiz, et al., 2011).

Cannabis has also been found to be effective at improving sleep quality in patients with fibromyalgia (Ware, Fitzcharles, Joseph & Shir, 2010).


Only the states of Arkansas, Illinois, North Dakota and Ohio have approved medical marijuana specifically for the treatment of fibromyalgia.

However, several states have approved medical cannabis specifically to treat “chronic pain,” a symptom commonly associated with fibromyalgia. These states include: Alaska, Arizona, California, Colorado, Delaware, Hawaii, Maine, Maryland, Michigan, Montana, New Mexico, Ohio, Oregon, Pennsylvania, Rhode Island and Vermont. The states of Nevada, New Hampshire, North Dakota, Montana, Ohio, Vermont, and West Virginia allow medical marijuana to treat “severe pain.” The states of Arkansas, Minnesota, Ohio, Pennsylvania, Washington, and West Virginia have approved cannabis for the treatment of “intractable pain.”

Sixteen states have approved medical cannabis for the treatment of spasms. These states include: Arizona, Arkansas, California, Colorado, Delaware, Florida, Hawaii, Maryland, Michigan, Minnesota, Montana, Nevada, New Hampshire, Oregon, Rhode Island and Washington.

A number of other states will consider allowing medical cannabis to be used for the treatment of fibromyalgia with the recommendation by a physician. These states include: California (any debilitating illness where the medical use of cannabis has been recommended by a physician), Connecticut (other medical conditions may be approved by the Department of Consumer Protection), Massachusetts (other conditions as determined in writing by a qualifying patient’s physician), Nevada (other conditions subject to approval), Oregon (other conditions subject to approval), Rhode Island (other conditions subject to approval), and Washington (any “terminal or debilitating condition”).

In Washington D.C., any condition can be approved for medical cannabis as long as a DC-licensed physician recommends the treatment.


Fibromyalgia patients experienced significant reductions in pain and stiffness, an enhancement of relaxation, and an increase in somnolence and feeling of well being, two hours after smoking or orally consuming cannabis.
Cannabis use in patients with fibromyalgia: effect on symptoms relief and health-related quality of life.

Cannabis medication found effective at improving sleep quality and was well tolerated by fibromyalgia patients.
The effects of nabilone on sleep in fibromyalgia: results of a randomized controlled trial.

Four weeks of cannabis treatment caused significant decreases in pain and anxiety in patients with fibromyalgia.
Nabilone for the treatment of pain in fibromyalgia.

Beneficial Cannabinoids and Terpenoids Useful for Treating Fibromyalgia

The cannabis plant offers a plethora of therapeutic benefits and contains cannabinoids and terpenoid compounds that are useful for treating the symptoms of Fibromyalgia. While most of the ongoing research focuses on CBD and THC, the following list also denotes which cannabinoids and terpenoids work synergistically with each other for possible therapeutic benefit. It may be beneficial to seek out strains that contain these cannabinoids and terpenoids.

"Marijuana Rated Most Effective for Treating Fibromyalgia"
Posted on April 21, 2014 in Fibromyalgia, Pain Medication

Medical marijuana is far more effective at treating symptoms of fibromyalgia than any of the three prescription drugs approved by the Food and Drug Administration to treat the disorder.

That is one of the surprise findings in an online survey of over 1,300 fibromyalgia patients conducted by the National Pain Foundation and National Pain Report.

The FDA has approved only three drugs – Cymbalta, Lyrica and Savella — for the treatment of fibromyalgia. Although they generate billions of dollars in annual sales for Pfizer, Eli Lilly, Forest Laboratories and other drug makers, most who have tried the medications say they don’t work.

The National Institutes of Health estimates that 5 million Americans suffer from fibromyalgia, a poorly understood disorder characterized by deep tissue pain, fatigue, headaches, depression, and lack of sleep. There is no known cure and the disorder is difficult to treat.

“Fibromyalgia is devastating for those who must live in its grip. There is much we do not understand. We need innovative ‘out of the box’ solutions that change the face of this disease,” said Dan Bennett, MD, an interventional spine and pain surgical physician in Denver, Colorado, who is chairman of the National Pain Foundation.

Many who responded to the survey said they had tried all three FDA approved drugs.

“The prescriptions that are available for treatment have more negative side effects than positive aspects,” said one fibromyalgia sufferer.

“I haven’t found anything! Please find a cure or at least a medicine that will take our pain away,” said another.

Asked to rate the effectiveness of Eli Lilly’s Cymbalta (Duloxetine), 60% of those who tried the drug said it did not work for them. Only 8% said it was very effective and 32% said it helps a little.

Among those who tried Pfizer’s Lyrica (Pregabalin), 61% said it did not work at all. Only 10% said it was very effective and 29% said it helps a little.

Asked to rate the effectiveness of Forest Laboratories’ Savella (Milnacipran), 68% of those who said they tried the drug said it didn’t work. Only 10% said it was very effective and 22% said it helps a little.

About 70% of the people who responded to the survey said they had not tried medical marijuana – which is not surprising given that it is still illegal in most states and many countries. But those who have tried marijuana said it was far more effective than any of the FDA-approved drugs.

Sixty-two percent who have tried cannabis said it was very effective at treating their fibromyalgia symptoms. Another 33% said it helped a little and only 5% said it did not help at all.

“I’ve found nothing that has worked for me, apart from marijuana,” said one survey respondent.

“Nothing but medical marijuana has made the greatest dent in the pain and mental problems,” said another.

“Marijuana does help a LOT it numbs the pain. But it doesn’t last long and it makes your brain foggy,” wrote another fibromyalgia sufferer.

Survey respondents said massage, swimming, acupuncture, muscle relaxers and other alternative treatments also helped relieve their symptoms. Many said they take opioids to relieve their pain – although narcotic painkillers are generally not prescribed to treat fibromyalgia.

Other survey findings:

Four out of ten (43%) fibromyalgia sufferers feel their physician is not knowledgeable about the disorder.

Over a third (35%) feel their physician does not take their fibromyalgia seriously.

45% feel their family and friends do not take their fibromyalgia seriously.

Nearly half (49%) said their fibromyalgia symptoms began at a relatively young age (18-34).

Only 11% were diagnosed with fibromyalgia within the first year of symptoms.

44% said it took five or more years before they were diagnosed with fibromyalgia.

Many survey respondents lamented that the disorder had taken over their lives, leaving them socially isolated, fatigued and in constant pain.

“I was once an active person and have now virtually become a hermit due to this disease,” said one.

“The worst thing about having fibromyalgia is disappointing loved ones when I can’t do things with them,” wrote one fibromyalgia sufferer.

“Having fibromyalgia is a life sentence. One simply cannot have a productive life living with this disease,” said another.

The 1,339 people who participated in the survey were self-selected as fibromyalgia sufferers. Ninety-six percent of them were female.

This was the second online survey of pain patients conducted by the National Pain Foundation and National Pain Report. The first survey found that over half of patients worry that they are perceived as “drug addicts” by pharmacists. Eight out of ten said they had stopped seeing a doctor because they felt they were treated poorly.

Clinical Endocannabinoid Deficiency

Since the discovery of the endocannabinoid system (ECS) and various phytocannabinoids beyond just tetrahydrocannabinol (THC), it seems that a sort of “shift” occurred in how we approach cannabis. “Clinical endocannabinoid deficiency” – sometimes (and less accurately) called “clinical cannabinoid deficiency – is actually an umbrella term for various conditions, in particular:

-Irritable Bowel Syndrome (IBS)
-Other treatment-resistant conditions that could be alleviated by cannabis use

Essentially, a CECD means “a lack of endocannabinoids”. The solution? Phytocannabinoids, which are found in abundance in cannabis. To state simply, a lack of cannabinoids could explain why conditions like migraine, fibromyalgia and IBS arise, and why people suffering from these conditions find cannabis to be therapeutic.

Now, there are a lot of conditions that could be linked to a CECD. This is perhaps because of the ECS’s intimate relationship with homeostasis (the balance of the body’s physiological processes), and there is still the chicken-or-egg question of “do these conditions arise because of a CECD, or does suffering from, say, multiple sclerosis or persistent headaches eventually cause a CECD?” The answer is likely to be “both”, and it could be one of the key reasons why cannabis is so useful for so many conditions.

The CECD concept comes from Dr. Ethan Russo, who is a leading researcher on cannabidiol (CBD) and was involved in the development of GW Pharmaceuticals Epidiolex – a CBD extract for epilepsy, and currently at Stage 3 development in the US. To see more of his work, check out the following links:

The original 2004 paper, which states:

“Migraine, fibromyalgia, IBS and related conditions display common clinical, biochemical and pathophysiological patterns that suggest an underlying clinical endocannabinoid deficiency that may be suitably treated with cannabinoid medicines.” However, the lack of evidence at the time made it just an “educated guess based upon some observable data and experimentation”.

As stated earlier, the evidence is mounting. Neurologist and Medical Scientist Ethan Russo is at the spearhead of this research. In this video he explains the concept of CECD and the importance of CBD. In 2016 Ethan Russo updated his findings in a peer reviewed journal that can be found here.

The abstract to Russo’s article states:

“Currently, however, statistically significant differences in cerebrospinal fluid anandamide levels have been documented in migraines, and advanced imaging studies have demonstrated ECS hypofunction in post-traumatic stress disorder. Additional studies have provided a firmer foundation for the theory, while clinical data have also produced evidence for decreased pain, improved sleep, and other benefits to cannabinoid treatment and adjunctive lifestyle approaches affecting the ECS.”

In a 2014 review published in the US National Library of Medicine journal, Scientists S.C. Smith and M.S. Wagner backed up Russo’s theories. The pair wrote, “…subsequent research has confirmed that underlying endocannabinoid deficiencies indeed play a role in migraine, fibromyalgia, irritable bowel syndrome and a growing list of other medical conditions. Clinical experience is bearing this out. Further research and especially clinical trials will further demonstrate the usefulness of medical cannabis. As legal barriers fall and scientific bias fades this will become more apparent.”

Can You Simplify This Further but With More Details, Doc?

Sure can! There are two main endocannabinoids that you should know about. They are:

Anandamide (C22H37NO2) – the body’s “joy” chemical. Anandamide is a fatty acid neurotransmitter, and is converted into ethanolamine (a primary amine and primary alcohol) and arachidonic acid (AA – a polyunsaturated omega-6 fatty acid) by the enzyme fatty acid amide hydrolase (FAAH). Anandamide’s effects can occur in either the central or peripheral nervous system (CNS or PNS), and its effects are mediated by CB1 cannabinoid receptors in the CNS and CB2 cannabinoid receptors in the PNS. Anandamide is the “naturally occurring THC”.
2-Arachidonoylglycerol (2-AG, C23H38O4) – an endogenous agonist (a chemical that binds to a receptor and activates it in order to induce a response) of the CB1 receptor. It is an ester formed from arachidonic acid (see above) and glycerol, and is found in high levels in the CNS. 2-AG’s activities are mediated by the enzymes phospholipase C (PLC) and diacylglycerol lipase (DAGL).
As you may have noticed, THC is the main phytocannabinoid that affects the cannabinoid receptors 1 and 2. The relationship between THC and anandamide, and why THC may help beat nausea (antiemetic) and muscle spasms. Anandamide also has a role to play in mood regulation and memory, which is why THC can affect memory as well as potentially help with post-traumatic stress syndrome and anxiety-related conditions.

CB1 receptors are found mostly in the CNS, and in smaller numbers in the liver, kidneys and lungs. CB2 receptors are found in the immune system and blood cells. CB2 receptors may play a role in inflammation, pain sensation and immune responses, and could also play a role in liver, kidney and neurodegenerative diseases.

Where Does CBD Fit Into All of This?

CBD doesn’t affect the CB1 and CB2 receptors directly. Rather, CBD activates other receptors, like the vanilloid, adenosine and serotonin receptors. To give some examples:

Transient Receptor Potential Cation Channel Subfamily V member 1 (TRPV1) – some people may recognise this protein being mentioned on articles surrounding Cannabis Hyperemesis Syndrome (CHS). This is because it is also known as the “capsaicin receptor”, or “vanilloid receptor 1”. This receptor plays a part in the mediation of inflammation, pain perception and body temperature, and CBD can help modulate this. CBD’s effects on TRPV1 may also be why it works as an anticonvulsant and control epileptic seizures. TRPV1 may be involved with the onset and progression of some forms of epilepsy (e.g. Dravet syndrome).

Adenosine A1 Receptor – CBD’s effects on this receptor suggests it may have an effect on regulating the heartbeat, exerting an antiarrhythmic effect. CBD’s effects on the A1 and A2 receptors have also been reported to have anti-inflammatory effects. Adenosine receptors also play a role in the release of the neurotransmitters dopamine and glutamate, which is why CBD may help treat schizophrenia treatment and other neurological conditions like dementia. CBD’s effects on dopamine may also be one reason why cannabis can be used for drug addiction.

5-Hydroxytryptamine receptor, subtype 1A (5HT1A) – a receptor that binds the endogenous neurotransmitter serotonin. CBD’s effects on this receptor suggest why it may function as an antidepressant and anxiolytic (anti-anxiety medication) for many people, and also why it may help as a painkiller – remember, SSRIs are also prescribed for chronic pain.

Furthermore, CBD inhibits the FAAH enzyme, which breaks down anandamide and affects the CB1 receptor (see above). This means that it can be used to “modulate” THC’s psychoactive effects, whilst the THC can help CBD do its job better. Indeed, there are some interesting studies taking place at California Pacific Medical Center, where specific concentrations of THC and CBD injected into breast and brain tumors eliminates those tumors completely, in 30 days! Exciting stuff!

Can a Person Have an “Overabundance” of Endocannabinoids? “Cannabinoid Abundance Syndrome” (“CAS”)?

Yes, this is also a theoretical possibility. In fact, it could be said that CHS is an overabundance of endocannabinoids, caused by the “build up” of phytocannabinoids over time, and thereby inducing nausea, vomiting and generally exerting negative effects on the TRPV1 receptor. Yes, this means that cannabis can “switch” from antiemetic to emetic! To confuse you even more, cannabis can potentially help treat cyclical vomiting syndrome (CVS), a condition that resembles CHS!

However, could it be said that there are conditions out there that are caused by having too many endocannabinoids, rather than too few? Could having too many cannabinoids, or even too many of some and a deficiency of others, explain why some people have negative reactions to cannabis, or why some strains have positive effect whereas others have a negative effect? This doesn’t seem all too crazy a supposition.

However, what conditions could be caused by by having too many cannabinoids, other than possibly CHS (which is rare)? Possibly, and it might help explain why, rather than dull pain, THC may heighten pain sensitivity for some long-term medical cannabis users. Although whether this is because medical cannabis users were more intolerant of pain in general is up for debate!

There isn’t much research on the opposite of CECD, but there may be some conditions that merit a “CAS” label. Could schizophrenia be said to be caused by having too much anandamide, hence why CBD may be useful as an antipsychotic? Whilst cannabis could be helpful for some people suffering from cluster headaches, it may actually make others feel worse. Could some kinds of cluster headaches be caused by having too many cannabinoids, whereas migraines and some other kinds are caused by a CECD?

Whatever the answers to these questions are, of this there is no doubt: the discovery of the ECS and various phytocannabinoids has revolutionized our understanding of the human body, and knowing more about it could provide us with some novel solutions to beating conditions ranging from chronic brain damage to autism to garden-variety headaches! And this is without even getting into terpenoids, which have effects of their own, and may also have an influence on the entourage effect.

Are there natural remedies or diets for fibromyalgia?

Unless we consider nutrition supplements as “natural”, there are currently no proven natural remedies or treatments for fibromyalgia, from a dietary aspect.

However, there are a few steps you can take yourself that may help prevent symptoms from escalating in the first place, so that they are much more tolerable.
Keep a daily food diary for at least 2 weeks

Many fibromyalgia sufferers report that certain foods trigger more severe symptoms than others.

In fact, one study found that 42% of fibromyalgia patients reported their symptoms worsened after eating certain foods (21). Discovering your own food sensitivities, and then cutting down or abstaining completely from those trigger foods, may be the most important thing you can do.

In order to do this, you must keep a daily food diary of what you eat and when, as well as if you had any bad reactions or symptoms. Doing this consistently for several weeks allows you to visually identify trends between what you eat and the symptoms.

Here is an example of a daily food diary from Healthy Food Guide NZ:

Food sensitivities that can cause symptoms will vary greatly between individuals, but the most common are dairy, gluten and FODMAPs. This brings us to the next step…
Try an elimination challenge diet

Once you have kept a food diary for at least 2 weeks, you can begin what is known as an elimination challenge diet.

As the name suggests, you eliminate certain foods for a period of time, usually three or four weeks. Then you slowly reintroduce specific foods and monitor your symptoms for possible reactions. This is the only way to determine what type of food may be causing your symptoms to get worse.

Elimination diets are best done under the supervision of a dietitian and is what I strongly recommend, but to give you an example of what to expect:

Based on your 2-week food diary, if (for example) you notice that symptoms are worse the day after you eat a large amount of pasta, gluten may be the culprit.

You would then eliminate all sources of gluten from your diet for at least 3 weeks (another reason why expert supervision is recommended) and observe the results. This allows all gluten to be cleared from your system, so you have a “clean slate” so to speak.

This is followed by a slow re-introduction of gluten-containing foods. At this point you will be able to see if gluten was causing you any problems or not.

Alternatively, you can eliminate numerous food groups all at the same time- which takes a lot more work (and supervision) – but has a much greater payoff down the track. Then you would reintroduce food groups one at a time.

Summary: Certain foods and food groups are often reported as triggers for fibromyalgia. By first identifying what foods give you problems, and then eliminating them in a systematic way, you can prevent or greatly minimise symptoms. This can be done with a daily food diary followed by an elimination challenge diet.
Maintaining a healthy weight is fundamental

There is no doubt that being overweight increases the pain in your joints.

The more weight on our skeleton, the more pressure that is applied to the bones and joints. Accordingly then, losing excess weight helps to relieve this pain.

But it appears that those who are overweight, and have fibromyalgia, experience increased muscle pain on top of the joint pain. A study of 179 diagnosed women, aged 20-75 years, found that being overweight was significantly associated with increased pain severity, reduced physical mobility, and poorer quality of life overall (22).

In other words, maintaining a healthy weight is fundamental to effectively treating fibromyalgia.

Now it’s unrealistic to expect that weight-loss exercise programs will be effective long-term when you consider how extreme fibromyalgia-related fatigue can be. Fortunately it’s well-established that what you eat is far more important than exercise when it comes to weight loss… so it all circles back to your diet.

Your priority should be finding a healthy eating pattern that you can sustain long-term, and that factors in your food sensitivities (if any).

Summary: Studies show that if you are overweight, fibromyalgia symptoms become much worse and much more difficult to treat. It is well-established that when it comes to weight loss, what you eat is far more important than exercise, which is why following a healthy diet should be your main priority.
Fibromyalgia and nutrition supplements

The link between fibromyalgia and diet is still a murky area of research.

To be honest, the scientific evidence available so far is quite inconclusive. But there have been some notable results with nutrition supplements, and several are worth consideration if you continue to struggle with symptoms:


Coenzyme Q10 (CoQ10), also known as ubiquinone, is a vitamin-like substance in our cells.

It functions as an antioxidant and the majority of CoQ10 is made by the body itself.

Those with fibromyalgia appear to have much lower concentrations of CoQ10 in the blood. This is linked with higher levels of cell damage, which is thought to be a big part in why it develops in the first place (8, 9).

In a small study of 35 patients, 20 of which had fibromyalgia, 300 mg of CoQ10 (ubiquinone) supplementation daily for three months was shown to increase CoQ10 levels back to normal (10).

Two other clinical trials also found improvements with doses of either 100 mg or 300 mg per day for at least 40 days. The higher dose especially was linked with less pain, fatigue, and joint soreness/stiffness (11, 12).

Based on these early studies, supplementation of at least 100 mg per day of COQ10 is recommended to anyone suffering from fibromyalgia. You can find a good range of CoQ10 supplements on amazon.

It is also worth ensuring you include some CoQ10-rich foods into your regular diet, such as herring, broccoli and cauliflower.


D-Ribose is an organic compound produced by the body.

It has a central role in metabolism, and is involved with energy production (ATP).

Those with fibromyalgia and chronic fatigue syndrome are thought to have reduced ATP levels (of which D-ribose is a component), so it’s been speculated that additional D-ribose may improve energy-related symptoms (13).

A case study of one woman with fibromyalgia observed that 10 grams of D-ribose per day, taken alongside other medication, greatly reduced symptoms. Those symptoms were said to have returned one week after the supplement was stopped (14).

The only study so far found that 15 grams of D-ribose per day for just under three weeks was associated with improvements in energy, sleep, and well-being with an increased pain threshold- as reported by the study participants themselves. However, know that the study was not well-designed and was carried out by a D-ribose supplement manufacturer (15).

D-ribose can be bought as an over the counter supplement, and there is a good range on Amazon, but I’d try CoQ10 first.

S-Adenosyl Methionine

S-Adenosyl Methionine (best known as SAMe) is a compound produced by the body that is involved in many chemical processes.

Low SAMe levels are associated with depressive symptoms, and supplementation may aid a partial deficiency.

Small studies that trialled SAMe injections on patients with fibromyalgia noted improvements in ratings of mood and muscle tenderness (16, 17).

This has been followed up with one clinical trial using oral SAMe supplementation.

The study included 44 subjects with fibromyalgia that were supplemented with 800 mg of SAMe per day for six weeks. Compared with those taking the placebo supplement, a dramatic improvement was observed for muscle tenderness, a minor benefit to morning stiffness, and no apparent benefit for muscular strength. Self-rated soreness and fatigue was also much greater in the SAMe group (18).

It certainly seems promising, but there has been no similar studies conducted since, which is generally required before we can draw any concrete conclusions.


Chlorella is a freshwater algae that is very similar to Spirulina.

One study on 18 subjects with fibromyalgia found that 10 grams of chlorella supplementation for two months was linked with a 22% reduction in pain (self-reported). Two people actually reported greater than 50% improvement (19).

The mechanism by which it would help with pain-relief is not understood as it is typically used to supplement nutrient deficiencies more than anything else. Study authors concluded that larger, more well-controlled studies are required before we make any sweeping statements about its effectiveness for fibromyalgia.


L-Carnitine is a compound made by the body that is involved in energy metabolism and cell protection.

It has been suggested that fibromyalgia may be associated with metabolic alterations including a deficiency in carnitine. Naturally then, supplementing a form of carnitine might help.

Similarly to chlorella, however, evidence it can benefit fibromyalgia patients is based entirely on one small study.

Researchers found that 1 gram of Acetyl-L-Carnitine (known as ALCAR) per day was associated with significant improvements in symptoms of fibromyalgia compared to placebo. Although note that this benefit was only experienced after 6 weeks of treatment (20).

Summary: A handful of nutrition supplements have been studied for treating symptoms of fibromyalgia. There is strong evidence that 100-300 mg per day of COQ10 supplementation can help, and D-ribose may be beneficial as well. But the evidence for SAMe, chlorella and L-carnitine is weak at this stage and should not be your first choice.
Fibromyalgia and diet: Final thoughts

Fibromyalgia is a complex condition to treat, but your diet appears to be a fundamental piece of the puzzle.

Aside from pharmaceutical drugs (which are proven to help), there is some good evidence that certain nutrition supplements, such as CoQ10, can help manage symptoms and relieve pain.

Almost half of all fibromyalgia patients also report that certain foods trigger their symptoms. Actively keeping a food diary, followed by an elimination diet challenge, is the only way to learn if any foods or nutrients are driving your symptoms.

Being overweight is also thought to exacerbate symptoms, so following an eating pattern that will help you maintain a healthy weight long-term is critical as well.

When you consider all these different elements, it’s evident that fibromyalgia is not in your head, it’s on your plate.

5 Food Rules For Fibromyalgia Patients

“Fibromyalgia symptoms are only about 30% amenable to current pharmaceutical strategies on the market,” says Kathleen Holton, PhD, MPH, lead author of Potential Dietary Links in Central Sensitization in Fibromyalgia.

That’s why many patients are taking matters into their own hands and experimenting with alternative treatments, including dietary changes. Forty-two percent of fibro patients reported that symptoms worsened after eating certain foods, and though much of the research is in its preliminary phases, there’s some evidence that simple diet tweaks may ease fibro pain.

Read on to get 5 food rules for fibromyalgia patients (just be sure to consult your doctor before drastically changing your diet).

1. Load up on vitamin D
Many adults are deficient in vitamin D to begin with, but this sunshine vitamin can be vital to fibro patients. "Vitamin D deficiency can mimic some of the symptoms of fibromyalgia. All patients should be screened for deficiency," says Holton. Studies show that vitamin D deficiencies can cause bone and muscle pain, and upping levels of this hard-to-get vitamin may help. A 2008 study found that pain patients with low levels of vitamin D required almost double the dose of painkillers as those with adequate levels. Holton recommends taking a supplement, especially during the wintertime.

2. Avoid additives
Common food additives, like monosodium glutamate (MSG) and aspartame, can act as excitotoxin molecules, a chemical group that has the ability to activate neurons that increase sensitivity to pain. Anecdotally, easing off these additives can help, and one very small study of four patients found that eliminating MSG and aspartame resulted in a reduction of fibromyalgia symptoms. The research is far from definitive, but it may be worth trying if you notice your symptoms worsen after Chinese takeout or too many diet drinks.

3. Say yes to fish

Omega-3 fatty acids, found in fatty fish, like salmon, walnuts, and flaxseed, are known to reduce inflammation and help prevent cardiovascular diseases. However, their soreness-reducing traits may also help pain patients. A 2007 study found that after just 3 months of supplementing omega-3 fatty acids, symptoms such as morning stiffness and painful, tender joints decreased. Though this study did not include fibromyalgia patients (it included rheumatoid arthritis (RA), irritable bowel syndrome (IBD), and dysmenorrheal patients), the results show promise. Fibro patients often have co-morbidities such as IBD and RA, so omega-3s may benefit them as well. Try adding salmon or walnuts to your diet, or, if you don’t like those foods, try adding flaxseeds to your cereal or oatmeal.

4. Nix the caffeine
Because sleeplessness is commonly associated with fibro, it may be tempting to fuel up on coffee to get through the day. This, however, may be a mistake. "Some patients use caffeine to compensate for not sleeping well, which can lead to a circular problem where the ‘solution’ of taking caffeine to stay awake is actually causing the problem of not sleeping at night," says Holton. Caffeine can set you up for a crash and, if sipped later in the day, may disrupt sleep schedules. Holton recommends antioxidant-packed decaffeinated green tea as a healthier alternative.

5. Veg out
Some researchers speculate that oxidative stress may be a cause of fibro symptoms. Oxidative stress occurs when the body doesn’t produce enough antioxidants to battle cell-damaging free radicals in the body. Most fruits and veggies are packed with important antioxidants, like vitamins A, C, and E, which fight free radicals to keep your body normalized. Certain studies also show a raw, vegan diet can improve symptoms, but that’s difficult for most people to follow. If you do choose to eat meat, though, opt for a small portion of grass-fed beef. "It is an excellent source of iron and vitamin B12, both nutrients which are extremely important in keeping your pain-processing nervous system healthy," says Holton.


Chiari malformation and syringomyelia. (n.d.). Mayo Clinic. Retrieved from

de Souza Nascimento, S., Desantana, J.M., Nampo, F.K., Ribeiro, E.A., da Silva, D.L., Araujo-Junior, J.X., da Silva Almeida, J.R., Bonjardim, L.R., de Souza Araujo, A.A., and Quintans-Junior, L.J. (2013). Efficacy and safety of medicinal plants or related natural products for fibromyalgia: a systematic review. Evidence-Based Complementary and Alternative Medicine, 2013. Retrieved from

Fibromyalgia. (2014, February 20). Mayo Clinic. Retrieved from

Fibromyalgia. (2014, July). National Institute of Arthritis and Musculoskeletal and Skin Diseases. Retrieved from

Fiz., J., Duran, M., Capella, D., Carbonell, J., and Farre, M. (2011, April). Cannabis use in patients with fibromyalgia: effect on symptoms relief and health-related quality of life. PLoS One, 6(4). Retrieved from

Russo, E.B. (2004, February-April). Clinical endocannabinoid deficiency (CECD): can this concept explain therapeutic benefits of cannabis in migraine, fibromyalgia, irritable bowel syndrome and other treatment-resistant conditions? Neuro Endocrinology Letters, 25(1-2), 31-9. Retrieved from

Skrabek, R.Q., Galimova, L., Ethans, K., and Perry. D. (2008, February). Nabilone for the treatment of pain in fibromyalgia. Journal of Pain, 9(2), 164-73. Retrieved from

Ste-Marie, P.A., Fitzcharles, M.A., Gamsa, A., Ware, M.A., and Shir, Y. (2012, August). Association of herbal cannabis use with negative psychosocial parameters in patients with fibromyalgia. Arthritis Care & Research, 64(8), 1202-8. Retrieved from

Ware, M.A., Fitzcharles, M.A., Joseph, L., and Shir, Y. (2010, February 1). The effects of nabilone on sleep in fibromyalgia: results of a randomized controlled trial. Anesthesia and Analgesia, 110(2), 604-10. Retrieved from

Weber, J., Schley, M., Casutt, M., Gerber, H., Schuepfer, G., Rukwied, R., Schleinzer, W., Ueberall, M., and Konrad, C. (2009). Tetrahydrocannabinol (Delta 9-THC) Treatment in Chronic Central Neuropathic Pain and Fibromyalgia Patients: Results of a Multicenter Survey. Anesthesiology Research and Practice, 2009. Retrieved from

Wissel, J., Haydn, T., Muller, J., Brenneis, C., Berger, T., Poewe, W., and Schelosky, L.D. (2006, October). Low dose treatment with the synthetic cannabinoid Nabilone significantly reduces spasticity-related pain: a double-blind placebo-controlled cross-over trial. Journal of Neurology, 253(10), 1337-41. Retrieved from

Tuesday, January 23, 2018

Three Different Cannabinoid-Based Medicines Approved by the FDA

The U.S. Food and Drug Administration (FDA) is aware that cannabis and cannabis-derived products are being used for a number of medical conditions, such as AIDS wasting syndrome, epilepsy, neuropathic pain, treatment of spasticity associated with multiple sclerosis, and cancer and chemotherapy-induced nausea.

Despite this fact, the FDA has not yet approved a marketing application for a drug product containing or derived from the whole cannabis plant. It has, however, approved three cannabinoid-based medicines derived from isolated synthetics: Marinol, Syndros, and Cesamet.

Marinol and Syndros include the active ingredient dronabinol, a synthetic delta-9- tetrahydrocannabinol (THC). Cesamet includes the active ingredient nabilone, which is synthetically derived and has a chemical structure similar to THC. While these synthetic drugs are afforded cultural and medical legitimacy, as well as tax breaks and open market privileges, cannabis users and manufacturers of cannabis-based products still risk incarceration and social marginalization.

We have been fooled time and time again. Medicines touting the claim of “FDA Approved” or “FDA Registered” can lull us into into a false sense of security and safety. FDA certification of a product is never a guarantee of safety or effectiveness of anything.

Many people are curious what products the FDA supports and why. Below you will find the three different [synthetic] cannabinoid-based products that are currently FDA approved:

Marinol (dronabinol)

Marinol is the brand name for an oral form of dronabinol (dro-NAB-in-all). It is indicated for treatment of anorexia associated with weight loss in patients with AIDS, and nausea and vomiting associated with cancer chemotherapy in patients who have failed to respond adequately to conventional antiemetic treatments.

Marinol capsules contain 2.5, 5, or 10 mg of dronabinol. Marinol does not contain any actual plant cannabinoids. Created to mimic natural delta-9-tetrahydrocannabinol (THC), dronabinol is a synthetically-derived cannabinoid designated chemically as (6aR-trans)-6a,7,8,10a-tetrahydro-6,6,9-trimethyl-3-pentyl-6H-dibenzo[b,d]pyran-1-ol.
What is dronabinol?

Dronabinol is a light yellow, sticky resinous oil formulated in sesame oil. It is insoluble in water and, therefore, only a fraction of the orally ingested compound reaches the patient’s circulation. This amount is further reduced by the action of the liver, which recognizes dronabinol as a contaminant, and removes it from the bloodstream. As a result, researchers have estimated that only 10 to 20 percent of the dronabinol in each capsule actually reaches its target in the body.

The important main difference between dronabinol and THC is the origin of their existence. Dronabinol is man-made and manufactured in a laboratory, while the actual THC cannabinoid is produced naturally by the cannabis plant.

Marinol Contraindications, Warnings, and Precautions

Marinol capsules contain sesame oil and should never be used by patients allergic to such.

Seizure and seizure-like activity have been reported in patients receiving Marinol capsules.

Patients with cardiac disorders should use precaution because of possible occasional hypotension, possible hypertension, syncope, or tachycardia.

Marinol can be addictive so capsules should be used with caution in patients with a history of substance abuse, including alcohol abuse or dependence, because they may be more prone to abuse Marinol as well.

Marinol capsules should be used with caution and careful psychiatric monitoring in patients with mania, depression, or schizophrenia because Marinol may exacerbate these illnesses.

Marinol capsules should be used with caution in patients receiving accompanying therapy with CNS drugs (drugs that are commonly used as sedatives, hypnotics, sleep aids, and anesthetics) because of the potential for additive or synergistic effects of those drugs.

Marinol capsules should be used with caution in elderly patients because they may be more sensitive to the neurological, psychoactive, and postural hypotensive effects of the drug.

Patients receiving treatment with Marinol capsules should be alerted to the potential for additive central nervous system depression if used with alcohol or other CNS depressants such as benzodiazepines and barbiturates.

Patients using Marinol capsules should be advised of possible changes in mood and other adverse behavioral effects of the drug so as to avoid panic in the event of such manifestations.

The History of Marinol

Unimed Pharmaceuticals, a subsidiary of Solvay Pharmaceuticals, was initially granted approval in 1985 for Marinol in a fixed-dose pill form for nausea. In 1992, appetite stimulation was added to its indications. It was classified as a Schedule I drug until it was moved to Schedule III in 1999. Marinol is manufactured by Patheon Softgels, Inc., for Abbvie Inc.

Prescribed for management of appetite loss associated with weight loss in acquired immune deficiency syndrome (AIDS), and nausea and vomiting associated with cancer chemotherapy in patients who have failed to respond adequately to conventional treatments to relieve nausea and vomiting, Marinol has become a $150+ million market.
The Cost of Marinol

The cost of Marinol varies, depending on the patient’s situation. A one-month supply often costs a patient between $200 and $800, with many reports of patients spending over $1,000. Most insurance companies will cover all or part of the cost of Marinol, or offer patient assistance programs sponsored by pharmaceutical companies to provide it free or at discounted prices to low income or uninsured and underinsured people who meet specific guidelines.

Syndros – (liquified dronabinol)

Last year, the FDA approved a new liquid formulation of dronabinol. The new version of the drug is made by DPT Lakewood LLC for Insys Therapeutics and is marketed under the brand name Syndros. Not surprisingly, Insys Therapeutics contributed at least $500,000 to Arizona’s successful anti-cannabis legalization efforts. Insys is also the company responsible for Subsys, a fentanyl-based medicine and a super opioid 50 times stronger than heroin.

Indications are the same for Syndros as they are for Marinol: anorexia associated with weight loss in patients with AIDS, and nausea and vomiting associated with cancer chemotherapy in patients who have failed to respond adequately to conventional treatment.

It has been suggested that Syndros could generate peak annual sales of up to $400 million.

Insys is also developing a cannabidiol (CBD)-based drug designed to treat severe pediatric epilepsy. The drug is currently in mid-stage clinical trials.

Cesamet (nabilone)

Cesamet (SES-uh-met) is the brand name for nabilone. Cesamet is a purely man-made synthetic drug that claims to activate the cannabinoid receptor CB1, which reduces proemetic signaling in the vomit center and thus inhibits nausea and vomiting. Cesamet claims it replicates the healing properties of delta-9- tetrahydrocannabinol (THC), but does not actually contain any of the constituents found in the Cannabis plant and thus, lacks the ability to tap into the entourage effect produced by whole plant cannabis medicines.

Cesamet is classified as an antiemetic. Antiemetics are medicines that help prevent or treat chemotherapy-induced nausea and vomiting (CINV). Cesamet is to be prescribed to people who continue to experience these symptoms after trying other traditional medications, specifically antiemetics, to find relief.
What is nabilone?

Nabilone is an orally active, man-made synthetic cannabinoid. In its raw form, nabilone is a white to off-white polymorphic crystalline powder. When dissolved in water, the solubility of nabilone is less than 0.5 mg/L, with pH values ranging from 1.2 to 7.0. Nabilone is (±)-trans-3-(l,l-dimethylheptyl)-6,6a,7,8,10,10a-hexahydro-l-hydroxy-6-6-dimethyl-9H-dibenzo[b,d]pyran-9-one and has the empirical formula C24H36O3. It has a molecular weight of 372.55.

A 1 mg Cesamet capsule contains 1 mg of nabilone and the inactive ingredients: povidone and corn starch. Povidone (polyvinylpyrrolidone, PVP) is used in the pharmaceutical industry as a synthetic polymer vehicle for dispersing and suspending drugs. When administered orally, nabilone appears to be completely absorbed from the human gastrointestinal tract.

Contraindications/Warnings/Precautions of Cesamet

Cesamet has complex effects on the central nervous system. Subjects given Cesamet may experience fast heart rate, changes in mood (euphoria, detachment, depression, anxiety, panic, paranoia), confusion, unusual thoughts or behavior, and hallucinations. These phenomena appear to be more common when larger doses of Cesamet are administered; however, a full-blown picture of psychosis may occur in patients receiving doses within the lower portion of the therapeutic range.

Potential to be abused and to produce psychological dependence. The simultaneous use of Cesamet and alcohol or barbiturates may produce additive depressive effects on central nervous system function.

Possible changes in mood and other adverse behavioral effects may occur.
History of Cesamet

In 1985, the FDA approved Cesamet when the drug was was being made by Eli Lilly and Company. According to news reports, Lilly discontinued the drug in 1989 for commercial reasons. Valeant Pharmaceuticals acquired Cesamet from Lilly in 2004. Cesamet is currently manufactured by Valeant Canada LP in Canada for Meda Pharmaceuticals.
Cost of Cesamet

The cost of Cesamet varies, depending on the patient’s situation. A one-month supply averages about $2,000 a month. Some insurance companies will cover all or part of the cost of Cesamet, or offer patient assistance programs sponsored by pharmaceutical companies to provide it free or at discounted prices to low income or uninsured and underinsured people who meet specific guidelines.
Other Medical Cannabis Drugs in Development

GW Pharmaceuticals is best known for its Sativex (naxibimol) oromucosal spray of a formulated extract (THC and CBD) of the cannabis plant. It has gone through many clinical trials as a treatment to relieve symptoms from multiple sclerosis. Expanding approval for the treatment of cancer pain and other applications is in the works. GW’s other notable drug is a proprietary oral solution of pure plant-derived cannabidiol (CBD) and is branded Epidiolex. This drug in the clinical trial stage as an epilepsy drug for children with uncontrolled seizures, and is also looking at expanding approval for other applications.

Corbus Pharmaceuticals is a small drug developer working on a new drug they call Anabasum. This synthetic oral endocannabinoid-mimetic drug binds to the CB2 receptor expressed on activated immune cells and fibroblasts. Corbus has reported positive mid-stage results in systemic sclerosis and cystic fibrosis.

Cara Therapeutics is a traditional drug developer trying to expand its products to include cannabinoid-based drugs. The most developed product in Cara’s pipeline is CR845, a kappa opioid receptor agonist (KORA). The experimental drug is designed to reduce the central nervous system side effects, like pain and itching, often observed with traditional opioids, such as morphine. Another product that is gaining traction is CR701, a CB receptor agonist. In pre-clinical studies, the administration of CR701 in animals with neuropathy suggested that it could possibly serve as an alternative to opioids to treat pain.

Zynerba Pharmaceuticals is a company wholly dependent on cannabinoid therapies. Zynerba has two drugs currently in development: ZYN001 is getting ready for mid-stage trial initiation in the second half of this year as a treatment for fibromyalgia and peripheral neuropathic pain. ZYN001 is a THC pro-drug patch that the company believes could have future uses for treating chronic pain and gastrointestinal disorders; and ZYN002 is a CBD-based gel that is absorbed through the skin, and aimed at treating adult epilepsy and osteoarthritis.

FAQ: FDA Approval & Medical Cannabis
Does cannabis and drugs like Marinol work the same?

The problem with medicines like Marinol is that most patients stop using it after just one round because of the side effects. Common side effects include dizziness, drowsiness, confusion, feeling “high,” an exaggerated sense of well-being, nausea, vomiting, and stomach/abdominal pain.

Can you microdose with Marinol and such?

Controlling the dosage of THC when taken in a pill form is practically impossible. To control appetite, a patient may benefit from as little as a hit or two, or a small piece of an edible. For this reason, microdosing is becoming more and more popular. However, once something like Marinol is swallowed, the patient is committed to it while it goes through the liver to be broken down and metabolised.

What are the drawbacks of synthetic THC?

The botanical version of cannabis boasts a number of positive side effects that are absent in its synthetic versions. There is overwhelming evidence that the efficacy of cannabis depends on the interaction of several or all of the compounds of whole plant medicine to create the so-called entourage effect. But there is less profit incentive for pharmaceutical companies to sell actual cannabis or whole plant extracts than there is to isolate and synthesize its components.
Why does the FDA approve synthetic THC but not cannabis itself?

It is rare for the FDA to approve or reject a botanical drug for therapeutic use, but not completely unheard of. In fact, it is not up to the FDA to reschedule or deschedule cannabis – that falls in the realm of the DEA. The FDA simply gives the go-ahead for clinical trials for drugs; however, the agency rarely receives applications for trials on cannabis. There is just no inducement for private pharmaceutical companies to invest hundreds of millions of dollars on a drug they would have no proprietary control over.

Why don’t cannabis-related companies apply for FDA approval?

Conducting clinical research using cannabis involves interactions with several federal agencies. This includes: (1) a registration administered by the Drug Enforcement Administration (DEA); (2) obtaining the cannabis for research from the National Institute on Drug Abuse (NIDA), within the National Institutes of Health, or another DEA-registered source; and (3) review by the FDA of an investigational new drug (IND) application and research protocol. As long as cannabis remains a Schedule I controlled substance under the Controlled Substances Act, jumping these hurdles is impossible for the average business.
Why does insurance cover synthetic drugs but not medical cannabis?

The cost of medical cannabis is not covered in most cases by insurance carriers. Drugs that are covered by insurance are typically required to pass FDA approval.

Will Marinol show up on a drug test?

A basic drug test doesn’t differentiate between THC from dronabinol products and THC from real cannabis.

In a clinical study by ElSohly, et al., delta-9- tetrahydrocannabinol (THC) was prepared synthetically and tested alongside a smoked dose of THC in a placebo joint and a smoked dose of cannabis containing both THC and delta9-tetrahydrocannabivarin (THCV). Because synthetic THC is chemically the same as naturally occurring THC, it was impossible to determine in a urine specimen surrendered for a drug test the source of the urinary metabolite of THC, namely, 11-nor-delta9-tetrahydrocannabinol-9-carboxylic acid (THC-COOH).

A drug test has been proposed that would use THCV as a marker for cannabis use. The molecular difference between THC and THCV is small but detectable. THCV is a natural component, along with THC, found in most cannabis products. THCV does not exist in a synthetic cannabinoid like dronabinol. In the ElSohly study, clinical data showed that THCV-COOH is detected in urine specimens collected from human subjects only after the ingestion of cannabis (orally or by smoking) and not after the ingestion of Marinol.

THC-COOH and THCV-COOH present – person has ingested cannabis in some form.

THC-COOH but no THCV-COOH present – a synthetic THC such as Marinol or Syndros has been ingested.

Citations & References

Medical Jane by Nanette Porteron May 01, 2017

Mack A, Joy J. Marijuana as Medicine? The Science Beyond the Controversy. Washington (DC): National Academies Press (US); 2000. 10, PHARMACEUTICALS FROM MARIJUANA. Available from:

Davis, Mellar, Vincent Maida, Paul Daeninck, and Joseph Pergolizzi. "The emerging role of cannabinoid neuromodulators in symptom management." Supportive Care in Cancer 15.1 (2006): 63-71. Web.

Elsohly, M. A., H. Dewit, S. R. Wachtel, S. Feng, and T. P. Murphy. " 9-Tetrahydrocannabivarin as a Marker for the Ingestion of Marijuana versus Marinol(R): Results of a Clinical Study." Journal of Analytical Toxicology 25.7 (2001): 565-71. Web.