Is CBD Psychoactive?

By Roger Chriss, PNN Columnist

The CBD boom is making Dutch Tulip Mania seem dull. CBD water is becoming a thing, and Ben & Jerry’s may soon introduce a CBD-infused ice cream. Basically, CBD is in everything.

The boom is built on the assumption that CBD, the cannabis cannabinoid known as cannabidiol, is not psychoactive. The FDA isn’t so sure and the DEA demurs, putting the CBD-based seizure drug Epidiolex into Schedule V last year.

So is CBD psychoactive? The answer hinges on the definition of the term psychoactive.

According to the World Health Organization: "Psychoactive substances are substances that, when taken in or administered into one's system, affect mental processes, e.g. cognition or affect.”

The National Institute on Drug Abuse explains psychoactive drugs this way: “Drugs in this category act on the central nervous system and alter its normal, everyday activity, causing changes in mood, awareness, and behavior.”

The term “psychotropic” is used with a similar meaning. MedicineNet states that a psychotropic drug is “any drug capable of affecting the mind, emotions, and behavior.”

But does CBD affect mental states, alter everyday activity, or change mood, awareness, or behavior?

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The FDA last year approved Epidiolex -- the first CBD-based medication -- for the treatment of two rare and severe forms of childhood epilepsy, Lennox-Gastaut syndrome and Dravet syndrome. CBD potentially has many other uses, including neurological conditions such as Alzheimer’s and dementia, and neuropsychiatric illness such as autism, ADHD, and PTSD.  It could also be beneficial for anorexia, anxiety, and mood disorders.

Purveyors of commercial CBD products go further, claiming that CBD may help with insomnia, social anxiety, and panic attacks. Although most product labels avoid specific claims of treatment efficacy to avoid FDA scrutiny, clear statements of possible benefits are easy to find online.

The FDA recently sent a warning letter to a New Jersey company for claiming that CBD can treat anxiety, depression, PTSD, schizophrenia, psychosis and obsessive compulsive disorder.

In order for CBD to do even half of this, it would have to have an effect on mental states, mood and awareness. In other words, CBD could not do what its proponents claim without being psychoactive, at least in the narrow, technical sense of the term.

Dose Matters

But details matter here. First, psychoactive does not mean intoxicating, hallucinogenic or dissociative. And many prescription drugs have benefits precisely because they are psychoactive. Even caffeine is arguably psychoactive, though only very weakly.

Second, dose matters. The pharmaceutical Epidiolex is administered in doses that have 10 to 100 times more CBD than a typical over-the-counter or commercial CBD product. So CBD may be psychoactive in therapeutic doses, but not in “commercial” doses. Of course, this assumes the product actually contains CBD, which in practice is not necessarily the case.

Third, route of administration matters. CBD is only weakly bioavailable and unstable in light or temperature extremes. A clear bottle of CBD water or CBD bath oil could easily lose much of the CBD it may contain, and the remaining CBD may not even be absorbed. And if the CBD is applied to non-vascularized tissue, as is the case with CBD mascara, then it cannot be psychoactive because of a lack of blood vessels for transport to the brain.

Thus, whether or not CBD is psychoactive depends on the amount and method that CBD is introduced to the human body. Since most of the claims from proponents remain unverified and in many cases untested even in animals, it could be premature to state that CBD is psychoactive in a specific way.

On the other hand, the existing work on CBD argues for calling CBD psychoactive. Recent findings by Yasmin Hurd showed that CBD, specifically Epidiolex, reduces cravings in people addicted to heroin. Ongoing research is demonstrating possible benefits of CBD for seizure disorders in humans and even in dogs.

Project CBD noted in 2016 that “as our scientific understanding and therapeutic experience deepens, the description of CBD as non-psychoactive may fall by the wayside.”

For now, it would be reasonable to say that CBD is probably “weakly psychoactive” at commercial doses but more “strongly psychoactive” at therapeutic doses. As more studies are completed on what CBD actually does, the pharmacological description of CBD can be updated accordingly.

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Roger Chriss lives with Ehlers Danlos syndrome and is a proud member of the Ehlers-Danlos Society. Roger is a technical consultant in Washington state, where he specializes in mathematics and research.

The information in this column should not be considered as professional medical advice, diagnosis or treatment. It is for informational purposes only and represents the author’s opinions alone. It does not inherently express or reflect the views, opinions and/or positions of Pain News Network.

Feds Warn CBD Marketers About False Medical Claims

By Pat Anson, PNN Editor.

The Food and Drug Administration and the Federal Trade Commission are tapping the brakes on the fast growing market for cannabidiol (CBD), warning companies not to make false claims that CBD products can be used to treat fibromyalgia, migraine, arthritis and other chronic illnesses.

The agencies sent warning letters to three companies — Nutra Pure, PotNetwork Holdings, and Advanced Spine and Pain — for making false and unsubstantiated health claims about a variety of CBD oils, extracts and edibles.

The FDA and FTC sent the warning letters on March 28 and gave the companies 15 days to respond.

Nutra Pure’s website, according to regulators, claimed that “CBD has demonstrated the ability to block spinal, peripheral and gastrointestinal mechanisms responsible for the pain associated with migraines, fibromyalgia, IBS and other related disorders.”

Claims were also made that CBD is “an effective and safe treatment alternative” for inflammatory conditions such as lupus, Celiac disease and rheumatoid arthritis.

Nutra Pure, which makes a line of hemp oil, has a small disclaimer on its website stating that “these products are not intended to diagnose, prevent, treat, or cure any disease.”

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PotNetwork has a similar disclaimer on its website, where it sells everything from CBD infused gummy bears and energy drinks to moisturizers and pet care products. According to the FDA, the company falsely claimed that CBD “blocked the progression of arthritis” and “has also shown the ability to kill cancer cells directly.”  

In addition to marketing CBD products, Advanced Spine and Pain also offers stem cell therapy, steroid injections, trigger point injections and ketamine infusions at its “Relievus” clinics in New Jersey and Pennsylvania.

‘Open Questions’ About CBD Safety

The federal crackdown on CBD marketing comes at a time when CBD products are starting to appear in mainstream stores. CVS Pharmacy and Walgreens started selling cannabis-based lotions, tinctures, edibles and lozenges in stores last month. The CBD products are being sold over-the-counter and without a prescription.  

The FDA and FTC announced no actions against CVS, Walgreens or other retailers selling CBD products, but they sent a clear message that the marketing of CBD will be closely watched.

“We treat products containing cannabis or cannabis-derived compounds as we do any other FDA-regulated products. Among other things, the FDA requires a cannabis product (hemp-derived or otherwise) that’s marketed with a claim of therapeutic benefit to be approved by the FDA for its intended use before it may be introduced into interstate commerce,” FDA commissioner Scott Gottlieb, MD, said in a statement. “Additionally, it is unlawful to introduce food containing added CBD, or the psychoactive compound THC, into interstate commerce, or to market CBD or THC products as dietary supplements.”

The 2018 Farm Bill removed hemp – a less potent strain of marijuana – from the Controlled Substances Act. That made hemp products legal to sell, but left the FDA in charge of regulating dietary supplements containing CBD. The agency is still trying to figure out how to regulate a product for which there is growing consumer demand, but little scientific evidence to support its use.

“While the availability of CBD products in particular has increased dramatically in recent years, open questions remain regarding the safety considerations raised by their widespread use,” Gottlieb said. “There are also unresolved questions regarding the cumulative exposure to CBD if people access it across a broad range of consumer products, as well as questions regarding the intended functionality of CBD in such products.”

Gottlieb has announced plans to hold a public hearing on May 31 to review the safety and effectiveness of CBD products. The FDA is also forming an internal working group within the agency to explore what regulatory changes would be needed for CBD products to be marketed legally.  

Study: THC More Effective Than CBD in Treating Pain

By Pat Anson, PNN Editor

The psychoactive ingredient in marijuana -- tetrahydrocannabinol (THC) – is more effective than cannabidiol (CBD) in treating chronic pain and other medical conditions, according to a new study that challenges the widespread belief that THC is harmful and has limited value in medical cannabis products.

Researchers at the University of New Mexico used the Releaf App, a mobile software program, to analyze self-reported data from over 3,300 people who logged their responses in nearly 20,000 user sessions to a variety of cannabis products, including natural dried flower, edibles, tinctures and ointments.

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Dried flower was the most commonly used product and was generally associated with greater pain relief than other cannabis products, regardless of the amount of THC.

"Despite the conventional wisdom, both in the popular press and much of the scientific community that only CBD has medical benefits while THC merely makes one high, our results suggest that THC may be more important than CBD in generating therapeutic benefits,” said Jacob Miguel Vigil, PhD, a professor in UNM’s Department of Psychology.

“In our study, CBD appears to have little effect at all, while THC generates measurable improvements in symptom relief. These findings justify the immediate de-scheduling of all types of cannabis, in addition to hemp, so that cannabis with THC can be more widely accessible for pharmaceutical use by the general public.”

Hemp is a strain of marijuana that was legalized by Congress in the 2018 Farm Bill. It has very low levels of THC, but is being grown commercially as a source for CBD.

UNM researchers found that indica strains of cannabis were more effective than sativa strains in treating pain and insomnia. Both strains have substantially higher levels of THC than hemp, but are illegal Schedule I controlled substances under federal law.

“Only THC potency levels showed independent associations with symptom relief and experiences of both positive and negative side effects, with higher levels (of THC) resulting in larger effects,” Vigil said.

Researchers say the relative weakness of CBD in treating symptoms may be due to inaccurate labeling of CBD content in cannabis products, which is a widespread industry problem. It’s also possible that THC simply heightens the experience or awareness of symptom relief.

Vigil published his findings in the journal Scientific Reports. Three of his co-authors developed the Releaf App, which has collected information from cannabis users since 2016. The app is an important data source for researchers, who are currently limited in conducting clinical studies of cannabis because of federal regulations.

Two previous studies by Vigil using data from the Releaf App found that cannabis provides significant relief from a wide range of symptoms associated with chronic pain, including insomnia, seizures, depression, anxiety and fatigue.

CBD Is Now Regulated and That May Be a Good Thing

By Roger Chriss, PNN Columnist

The legal status of cannabidiol (CBD) is changing. Once classified exclusively as a Schedule I drug under the Controlled Substances Act, CBD is now legal under federal law. And this means regulation.

The 2018 Farm Bill removed hemp from Schedule I. Hemp is a strain of marijuana with very low levels of THC, but high amounts of CBD.  This has opened the door to a legal market for CBD products, including food and supplements. But there’s a catch. The FDA has strict regulations about CBD being used in dietary supplements or promoted as medical treatments.

“It’s unlawful under the FD&C Act (Federal Food, Drug, and Cosmetic Act) to introduce food containing added CBD or THC into interstate commerce, or to market CBD or THC products as, or in, dietary supplements, regardless of whether the substances are hemp-derived,” FDA commissioner Scott Gottlieb, MD, said in a December 2018 statement.

“Among other things, the FDA requires a cannabis product (hemp-derived or otherwise) that is marketed with a claim of therapeutic benefit, or with any other disease claim, to be approved by the FDA for its intended use before it may be introduced into interstate commerce. This is the same standard to which we hold any product marketed as a drug for human or animal use.”

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 The FDA has a FAQ page about cannabis that answers some basic questions:

"Can products that contain THC or cannabidiol (CBD) be sold as dietary supplements? A. No."

"Is it legal, in interstate commerce, to sell a food to which THC or CBD has been added? A. No."

The FDA has reason to be concerned. Product quality for CBD products is iffy at best. An investigation by the NBC affiliate in Miami (see “Patients Are Being Duped”) found that 20 of 35 CBD products tested had less than half the amount of CBD advertised on the label. Some samples had no CBD at all.

Other recent analyses have found THC, pesticides, synthetic cannabinoids and toxic solvents in CBD products.

Moreover, a lack of regulatory oversight has led to an abundance of false, misleading or unsubstantiated claims. A recent review of CBD in the Journal of Clinical Pharmacology found that “CBD has been touted for many ailments for which it has not been studied, and in those diseases with evaluable human data, it generally has weak or very weak evidence.”

There is a lot of research on CBD going back years. The FDA’s approval of the CBD-based drug Epidiolex for rare childhood seizure disorders and a 2018 review that found potential for treating multiple sclerosis symptoms are important indicators of CBD’s medical value. At the same time, researchers have found no benefit in treating spinal cord injury, Crohn’s disease and osteoarthritis.

Yet CBD is now being widely promoted as a wellness product, and added to everything from coffee and pastries to bath oils and mascara. So it is not surprising that the FDA is concerned that people may be duped or put at risk.

The FDA is not alone in this. The New York City Department of Health has banned CBD products from being sold in bars and restaurants. Maine, New York, and Ohio are also banning CBD edibles.

For medically complicated people with chronic illness, regulation could be beneficial. At present these patients face significant risks with CBD products. Tainted CBD may cause unexpected allergic reactions or drug interactions. And contaminated CBD could trigger a positive result on a urine drug test, a common part of pain management amid the opioid crisis. Regulatory oversight could help reduce these risks. 

The legal and regulatory landscape surrounding CBD is shifting quickly. The FDA and state government agencies are watching closely and starting to intervene. This may flush out bad actors in the CBD marketplace and improve product quality and reliability. A stable marketplace with reliable products may be a net gain for the people who stand to benefit the most from CBD.

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Roger Chriss lives with Ehlers Danlos syndrome and is a proud member of the Ehlers-Danlos Society. Roger is a technical consultant in Washington state, where he specializes in mathematics and research.

The information in this column should not be considered as professional medical advice, diagnosis or treatment. It is for informational purposes only and represents the author’s opinions alone. It does not inherently express or reflect the views, opinions and/or positions of Pain News Network.

Will Cannabis Change the Candy Industry?

By Crystal Lindell,  PNN Columnist

A bag of Heady Harvest CBD Gummies sold by CBD Genesis doesn’t look that much different than any other bag of gummies in the candy aisle — sleek packaging, a clear front panel to show the product and a well-designed logo. And you can find bags just like them hanging right there on the shelf in many gas stations, not too far from the energy drinks and lottery tickets.  

It’s exactly the type of packaging that’s making CBD go mainstream. In fact, the only thing that makes them any different than a regular bag of gummies is the price — $24.99 for just 20 bears.

CBD, which stands for cannabidiol, is a compound found in marijuana plants, and the product is typically sold over the counter in the form of drops, candy and other products.

“The natural compound, called cannabidiol, is one of more than 100 cannabinoids found in the cannabis plant,” says BDS Analytics. “On its own it won’t get people high. But researchers are finding more and more medical applications for CBD, and consumers and companies increasingly are exploring the compound.” 

The firm says that while the broad marijuana edibles category grew by 36 percent for much of last year in Colorado, Oregon and Washington, high-CBD edibles expanded by 110 percent. 

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And high-CBD chocolates reached 217 percent growth on $11.45 million in sales, while high-CBD candy grew by 169.5 percent last year, compared to 51 percent for candy in general, according to BDS.  

Legally, it's still very much a gray area, though. 

According to recent article in the Wall Street Journal, “DEA spokesman Melvin Patterson says CBD-containing product appearing on shelves ‘is there illegally,’ but enforcement is not a priority for the agency, which is focused on the opioid crisis. In the states that have legalized cannabis use, ‘DEA is not after that. That would take a lot of manpower that DEA doesn’t have,’ he says.” 

And with the product being sold over the counter in many places, it can be confusing for consumers who think they’re buying something that’s totally above board. 

It’s that kind of murky gray area that understandably makes it hard for more mainstream candy companies to get involved in the market. But as the products grow in popularity, it’s hard to ignore their potential financial impact. 

It’s not that crazy to picture a day when Hershey, Mars or other major manufacturers are launching their own lines of CBD candy. How long that takes may only depend on how long for-profit companies want to ignore what is clearly becoming a for-profit market segment. 

This article originally appeared in Candy Industry and is republished with permission.

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Crystal Lindell is a journalist who lives in Illinois. She eats too much Taco Bell, drinks too much espresso, and spends too much time looking for the perfect pink lipstick. Crystal has hypermobile Ehlers-Danlos syndrome. 

Crystal writes about it on her blog, “The Only Certainty is Bad Grammar.”

The information in this column should not be considered as professional medical advice, diagnosis or treatment. It is for informational purposes only and represent the author’s opinions alone. It does not inherently express or reflect the views, opinions and/or positions of Pain News Network.

Cannabis Somewhat Effective in Treating MS

By Pat Anson, PNN Editor

Medical cannabis is mildly effective in relieving pain and other symptoms in patients with multiple sclerosis (MS), according to a new study published in JAMA Network Open.

Spanish researchers analyzed 17 clinical trials involving over 3,100 patients – one of the largest reviews to date on the efficacy of cannabinoids in treating MS. Overall, they found that cannabis was safe, but had limited effectiveness in relieving pain, muscle spasticity and bladder dysfunction.

“Small but statistically significant differences were found in favor of cannabinoids for all 3 symptoms,” Marissa Slaven, MD, and Oren Levine, MD, of Ontario’s McMaster University said in a JAMA commentary. “The authors conclude that cannabinoids provide a mild reduction in subjective outcome assessment of uncertain clinical significance and that they are safe.”

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MS is a chronic and incurable disease which attacks the body’s central nervous system, causing numbness in the limbs, difficulty walking, paralysis, loss of vision, fatigue and pain.

Medications and disease modifying drugs currently used to treat MS can cost tens of thousands of dollars a year – so a low-cost alternative treatment would be welcomed by many patients.

Four different medical cannabinoids were used in the 17 trials that were evaluated. They contained different levels of cannabidiol (CBD) and tetrahydrocannabinol (THC), the active ingredient in marijuana that makes people high. A lot of uncertainty remains about whether CBD or THC are more effective in relieving MS symptoms – something the JAMA study failed to resolve.

“It is critical that researchers gain a deeper understanding of both of the major (THC and CBD) and minor components of this therapy to unlock its full potential,” said Slaven.

“Given the relative safety of these agents, lack of strong evidence of other effective treatment options, and increasing access in some jurisdictions, it may seem appealing to include cannabinoids in the armamentarium of therapies for MS. But carefully conducted, high-quality studies with thought given to the biologic activity of different cannabis components are still required to inform on the benefits of cannabinoids for patients with MS.  

"The bottom line is there is certainly something happening with cannabinoids in regard to symptoms," Nicholas LaRocca, vice president of healthcare delivery and policy research at the National Multiple Sclerosis Society, told HealthDay. "In spite of very strong interest in cannabinoid therapy, we really have relatively little in terms of good research to guide us in terms of what does and what doesn't work, what works for which types of individuals, and so forth."

A small study was recently launched in Australia that might answer some of those questions. Emerald Health Pharmaceuticals of San Diego is using a synthetic version of CBD – called EHP-101 -- to treat about 100 people who suffer from MS or scleroderma, another autoimmune disease. The placebo controlled Phase I trial is meant to determine whether EHP-101 is safe and has any side effects. Results are expected next year.

Ohio Banning Sales of Kratom and CBD  

By Pat Anson, PNN Editor

At a time when many pain sufferers are turning to natural supplements to relieve their pain, the state of Ohio is moving to ban two of the most popular ones.

The Ohio Board of Pharmacy voted Monday to classify kratom as a Schedule I controlled substance alongside heroin, LSD and other dangerous drugs. The move came two months after the board issued an advisory warning that sales of CBD-infused products are illegal under Ohio’s new medical marijuana program.

The pharmacy board considers kratom – which come from the leaves of a tree that grows in southeast Asia – a “psychoactive plant” that can cause hallucinations, psychosis, seizures and death. State health officials have identified six recent deaths in Ohio in which kratom “was indicated as the primary cause of death.”

A recent report from the Ohio Substance Abuse Monitoring Network (OSAM) raised the demonization of kratom to a new level by comparing it to heroin — and falsely claiming it was common for people to inject kratom.

“Participants reported that the drug looks similar to brown powdered heroin, produces similar effects as heroin, and is primarily used by individuals subject to drug screening and by people addicted to heroin who use the drug to alleviate opiate withdrawal symptoms,” the OSAM report warns.

“Participants reported that the most common route of administration for kratom is intravenous injection (aka “shooting”). Participants in the Akron-Canton region estimated that out of 10 kratom users, seven would shoot the drug and three would orally consume the drug (including drinking it as a tea).”

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Monday’s vote by the pharmacy board starts a months-long process of drafting new regulations for kratom. Public comments will be accepted until October 18.  Over 1,500 comments have already been received, most of them from kratom users asking the board to keep the supplement legal.

"The findings of the Ohio Board of Pharmacy… parrot the false propaganda of the U.S. Food and Drug Administration in their crusade to ban kratom," said Dave Herman, chair of the American Kratom Association, which represents kratom vendors and consumers. "The FDA has flooded state regulators, including the Ohio Board of Pharmacy with false claims and disinformation about the addiction profile and safety of this safe botanical plant.

“The nearly 5 million kratom consumers, and the tens of thousands of Ohio citizens, who safely consume kratom as a part of their health and well-being regimen should not have that freedom infringed upon by any regulation that is premised on bad science, inaccurate data provided by the FDA, and a deliberate attempt to manipulate the scheduling process by a federal agency.”

Kratom has been used for centuries as a pain reliever and stimulant, particularly in rural areas of Indonesia and Thailand.  In recent years, millions of Americans have discovered kratom and started buying it online or in “head shops” as a treatment for pain, addiction, anxiety and depression.

The Food and Drug Administration maintains that kratom is not approved for any medical use and insists on calling the plant an “opioid,” although its active ingredients are mitragynine and 7-hydroxymitragynine, two alkaloids that act on opioid receptors in the brain.

Kratom is already banned in Alabama, Arkansas, Indiana, Vermont, Wisconsin and the District of Columbia. There is speculation that the FDA and DEA may also seek to classify kratom as a Schedule I controlled substance, which would make sales and possession of the plant illegal nationwide. The DEA withdrew a plan to ban kratom in 2016 after a public outcry.

CBD Sales Banned

Ohio’s crackdown on CBD sales is not as restrictive as the ban on kratom. CBD infused products such as edibles, tinctures and oils usually contain little or no THC – the psychoactive ingredient in marijuana that makes people high. Many people use CBD to relieve pain and help them sleep.

Under state law, marijuana is defined as “all parts of a plant of the genus cannabis” and only state-licensed dispensaries can sell products made with CBD (cannabidiol). There will eventually be 56 dispensaries across the state, although none are expected to open until later this year.

Some retailers pulled CBD products from their shelves after the warning from the pharmacy board, but many have chosen to sell off their supplies first. One retailer in Dayton predicts the price of CBD products will soar once they are no longer widely available.

“The prices, if they’re going to skyrocket, are going to hurt customers’ pockets,” Rabi Ahmad told WHIO.com. “Senior citizens mostly buy the CBD. The young kids, they don’t buy CBD at all.”  

A spokesman for the pharmacy board said there are no state plans to enforce the ban on CBD sales, although local law enforcement agencies could. Also unclear is how the ban will affect online sales and shipments from out-of-state vendors.

“The public should have uninhibited access to hemp-derived products no matter what state you live in. We will continue to produce these products and support our retailers and customers through this moment of confusion,” Nic Balzer, CEO of QC Infusion, a Cincinnati-based manufacturer of CBD products, told Cincinnati.com.

A Reality Check for CBD Oil

By Roger Chriss, PNN Columnist

The Food and Drug Administration’s recent approval of the anti-seizure medication Epidiolex has attracted a lot of new attention for CBD (cannabidiol). But enthusiasm was already on the rise. CBD is being promoted as a “new medical elixir” and marketed in everything from cosmetics to bottled water.

CBD was isolated in marijuana in 1940 and its chemical structure was characterized in 1963. It does not have euphoric effects and is increasingly being used in oils, edibles and other forms to treat medical conditions such as pain.

Last November the World Health Organization released its “Cannabidiol Pre-Preview Report”) stating that “CBD is generally well tolerated with a good safety profile.” The WHO report found “no evidence of recreational use of CBD or any public health related problems associated with the use of pure CBD.”

Last month the FDA approved Epidiolex, a CBD-based drug, to treat seizures caused by two rare forms of childhood epilepsy, Dravet syndrome and Lennox-Gestaut syndrome.  It was the first -- and so far only -- marijuana-based drug to be approved by the agency.

“In terms of solid evidence, the one thing we really know about CBD is that it can be helpful for rare childhood seizure disorders,” Ryan Vandrey, PhD, a cannabis researcher and associate professor of psychiatry at Johns Hopkins University, told Health.com. “There’s not yet sufficient evidence to support its use for any other reason.”

This is not for lack of effort. Zynebra Pharmaceuticals recently tested a topical CBD product for osteoarthritis knee pain with mixed results. The Phase 2 clinical study did not meet its primary endpoint of reducing the average pain score, although there were some indications it improved function and reduced pain severity.

A small clinical trial of CBD for Crohn’s disease in Israel in 2017 was also negative, finding “CBD was safe but had no beneficial effects.”

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GW Pharmaceuticals, the manufacturer of Epidiolex and Sativex, conducted a clinical trial in 2012 on CBD oil for pain due to spinal cord injury. The outcome was disappointing. The treatment arm of the study (55 subjects) and placebo arm (59 subjects) showed essentially the same level of improvement in neuropathic pain.

A 2015 study on CBD extracts for childhood epilepsy had puzzling results. Researchers reported in the journal Epilepsy & Behavior that “relocating to Colorado had a significant effect on response rates.” Drugs are not normally affected by zip code or time zone.

A recent review of studies on CBD oil and other forms of cannabis for the management of neurologic disorders was more positive, finding “there is strongest evidence to indicate benefits in treatment of spasticity and neuropathic pain in multiple sclerosis.”

CBD Safety Questions

But there are also cautions. Thorsten Rudroff, PhD, a professor of Health and Exercise Science at Colorado State University, told Neurology Advisor that more studies of CBD were needed.

“While cannabis seems to be effective for the treatment of MS symptoms like pain and spasticity, there are so many unknowns. For example, we don't know much about interactions with other drugs. Also, based on my own research, it seems that cannabis may further impair cognitive function in people with MS, especially in older adults,” Rudroff said.

There are safety issues as well. CBD oil has a good safety profile, but according to Food Safety Magazine, CBD oil products have problems with labeling accuracy, product quality and contaminants.

People with serious medical problems who want to use CBD oil need to reliably source a quality product. Medical users may have allergies, chemical sensitivities and, in the case of cancer patients or people with autoimmune disorders, a compromised immune system. For such people, purity and dose matter.

In addition, there are drug interactions to be aware of. Medline lists nearly a dozen medications that potentially interact with CBD, such as amitriptyline, ibuprofen and meloxicam, which are frequently used by people with health problems.

The decision to use CBD oil for medical purposes needs to be based on science, not marketing. As David Cassaret, MD, notes in his book, Stoned: A Doctor’s Case for Medical Marijuana: “Medical marijuana is becoming too widespread, and the risks are too great, to leave the patient to fend for himself, and to let the buyer beware.”

At present, however, CBD oil is very much a buyer beware world. And the current hype is not helping.

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Roger Chriss lives with Ehlers Danlos syndrome and is a proud member of the Ehlers-Danlos Society. Roger is a technical consultant in Washington state, where he specializes in mathematics and research.

The information in this column should not be considered as professional medical advice, diagnosis or treatment. It is for informational purposes only and represents the author’s opinions alone. It does not inherently express or reflect the views, opinions and/or positions of Pain News Network.

Most Cannabidiol Oils Sold Online Mislabeled

By Pat Anson, Editor

With opioid medication increasingly harder to obtain and other types of pain relievers often ineffective, many chronic pain sufferers have turned to cannabidiol-based medication for relief.

But a new study published in JAMA has found that nearly 70 percent of all cannabidiol (CBD) products sold online are either over or under-labeled. Researchers say a number of CBD products that are used to treat pain, anxiety, epilepsy and other medical conditions also contain high-levels of tetrahydrocannabinol (THC), the substance in marijuana that makes people high.

“The biggest implication is that many of these patients may not be getting the proper dosage; they’re either not getting enough for it to be effective or they’re getting too much,” said lead author Marcel Bonn-Miller, PhD, an adjunct professor of psychology at the Perelman School of Medicine at the University of Pennsylvania

“This is a medication that is often used for children with epilepsy, so parents could be giving their child THC without even knowing it.”

Like THC, CBD is one of the active ingredients in marijuana, but it is not generally known to produce euphoria or make people high. CBD is currently classified as a Schedule I controlled substance by the federal government, even though it has been legalized for medicinal use in 29 states and the District of Columbia.

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Bonn-Miller says the mislabeling and poor quality control of CBD products is a direct result of inadequate regulation.

“The big problem, with this being something that is not federally legal, is that the needed quality assurance oversight from the Food and Drug Administration is not available. There are currently no standards for producing, testing, or labeling these oils,” Bonn-Miller said. “There is no way to know what is actually in the bottle. It’s crazy to have less oversight and information about a product being widely used for medicinal purposes, especially in very ill children, than a Hershey bar.”

Bonn-Miller and his colleagues searched the Internet and purchased 84 CBD products from 31 different companies. They found that four out of ten products were under-labeled, meaning they contained a higher concentration of CBD than indicated. Another 26 percent of products purchased were over-labeled, meaning they contained a lower concentration of CBD than indicated.

Only 30 percent of CBD products purchased contained an actual CBD content that was within 10% of the amount listed on the product label. THC was detected in 21% of the samples.

“This is a wake up call for the CBD industry to standardize their products,” said co-author Jahan Marcu, PhD, Chief Science Officer for Americans for Safe Access (ASA).

“CBD product manufacturers need to adopt best practices and accept guidance from AHPA (American Herbal Products Association) and other groups to improve consistency and safety for consumers.”

ASA and AHPA supports the Patient Focused Certification (PFC) program, a non-profit, peer reviewed, third party certification program for the medical cannabis industry. Products that carry the PFC label have met their standards and been certified.

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“I am constantly contacted for suggestions for a safe company that sells CBD - and it would be helpful to steer people in the right direction,” said Ellen Lenox Smith, a medical marijuana user, advocate and PNN columnist.

“Although less or more CBD won't hurt you, it makes sense to develop a method for people to know they are getting the correct product that is being claimed. If THC is found in the product, then someone out there is not abiding by the law and is using a form of cannabis, thus breaking the law.”

The problem isn’t limited to CBD oils and extracts. In a previous study, Bonn-Miller and his colleagues analyzed cannabinoid dose and label accuracy in edible marijuana products and found similar discrepancies. He hopes this and future studies will call attention to the impact of inconsistent cannabis product labelling.

“Future research should be focused on making sure people are paying attention to this issue and encouraging regulation in this rapidly expanding industry,” Bonn-Miller said.

Strong Support for Cannabis Rx in Comments to FDA

By Pat Anson, Editor

The Food and Drug Administration may have gotten more than it bargained for when it asked for public comments about the medical value and abuse potential of 17 different drugs.

The agency wound up getting over 6,400 comments in the Federal Register, the vast majority of them from people advocating for cannabidiol (CBD) -- one of the active ingredients in medical marijuana.  

Unlike tetrahydrocannabinol (THC), the substance in marijuana that makes people high, CBD-based oils and medications relieve pain, and are increasingly being used to treat a variety of medical conditions.  

“CBD's are not a way to get high as THC is. These oils have so many beneficial uses for anxiety, stress, pain, joint issues, muscular issues, arthritis, seizures, Parkinson's, cancer,” wrote Tami Camp in her public comment. “We need natural herbs, not man-made poisons!”

“CBD helps me with my chronic nerve pain, in a way that prescription medications can't match,” wrote Jason Turgeon.

“I've been consistently using CBD oil now for three months and have noticed an uptick in my moods, a reduction of joint pain, and my sleeping cycles at night have improved as my sleep is deeper and I wake up feeling refreshed,” wrote Kerry Meier.

Public opinion polls show that these are not isolated comments or marijuana supporters trying to game the system by flooding the Federal Register with comments. A recent poll by CBS News found 85% of Americans favor medical marijuana use.

drug policy alliance photo

drug policy alliance photo

But while medical cannabis may be legal in 29 states and the District of Columbia, marijuana is still classified as an illegal Schedule I controlled substance by the Drug Enforcement Administration, right alongside heroin and LSD.

The FDA opened the cannabis can of worms at the behest of the World Health Organization (WHO), which is not only reviewing the safety and effectiveness of CBD, but 16 other drugs -- including pregabalin, tramadol, ketamine, and several chemical cousins of fentanyl, a synthetic opioid blamed for thousands of overdose deaths. 

WHO is seeking input from the FDA on whether international restrictions should be placed on any of the drugs. Under the Controlled Substances Act, the FDA was required to seek public comment in the Federal Register before responding to WHO -- perhaps not anticipating the overwhelmingly positive response that CBD would get. 

“Cannabidiol should not be restricted because CBD is not addictive, nor does it have the potential for abuse nor should it be tied to hallucinogenic drugs. Therefore, no international restrictions should be placed on CBD,” wrote Steve Easterly.

“For cannabis to be scheduled as a class I drug is ludicrous especially when the entire prohibition of cannabis was based on lies,” wrote Mike Copple. “What a shameful spectacle that we the people still have to argue about the usefulness of the cannabis plant. Cannabis has and continues to help me in many ways both physically and mentally.”

“I want cannabis to be legalized and available for over the counter sale. I have known several people who have benefited for various conditions from anxiety, depressions, MS, arthritis and epilepsy,” wrote Nancy Scott-Puopolo.

The public comment period ended on Wednesday. You can look at other responses in the Federal Register by clicking here

Mixed Reviews of Lyrica

There were only a few dozen comments about pregabalin (Lyrica), a prescription medication that millions of Americans take for fibromyalgia, neuropathy and other chronic pain conditions. As PNN has reported, WHO is investigating reports that pregabalin is being abused by addicts.

“Patients are self-administering higher than recommended doses (of pregabalin) to achieve euphoria, especially patients who have a history of substance abuse, particularly opioids, and psychiatric illness,” WHO told the FDA..

The public comments about pregabalin were mixed at best.

“I have been on several medications prior to being switched to Lyrica about six months ago. I actually feel nothing while taking the drug, and assume you would indeed have to take lots to maybe feel high,” wrote Mary. “Not sure if it helps my fibromyalgia or not since I still have lots of pain.”

“I take pregabalin in Lyrica form twice a day currently for nerve pain and fibromyalgia. I cannot accurately express the relief this has brought me,” wrote Renee.

“I have tried many, many medications. When I tried Lyrica, the side effects were horrible. I couldn't even lift my head without severe dizziness and the room spinning,” said Lora Berry.  

“I take Lyrica and all I got from it was fatter,” said Debra Winegar. “CBD oil is wonderful. Take a few drops under the tongue and I'm good to go. Narcotics are needed when my pain is out of control. I'm tired of waiting to be pain free. Legalize pot now!”

Will the FDA now report to WHO that thousands of American citizens want CBD-based medications fully legalized?  The FDA notice in the Federal Register only notes that public comments “will be considered” when the FDA prepares its scientific and medical evaluation. The FDA report to WHO is due September 30.