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.”

 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.

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.

‘Cannabis Tourism’ Linked to More Fatal Accidents

By Pat Anson, PNN Editor

Has marijuana legalization made driving more dangerous?  There have been conflicting claims over the years that states where cannabis is legal have more car crashes. And one recent study found that over half of medical cannabis users drive while impaired.

A new study adds a little more clarity to the issue.

Researchers at Monash University in Australia looked at traffic fatalities in three U.S. states where recreational cannabis was legalized (Colorado, Washington and Oregon), and in eight neighboring states and British Columbia.

They found there was an average of one additional traffic fatality for every million residents. That may not sound like much, but when you consider there were 27 million people in the affected areas, it adds up to 170 additional deaths in the first six months after legalization.

Many of the additional deaths were attributed to “cannabis tourism” in which people in neighboring states and provinces purchased recreational cannabis in legalized states and then drove home while under the influence.

"The results suggest that legalizing the sale of cannabis for recreational use can lead to a temporary increase in traffic fatalities in legalizing states. This spills over into neighboring jurisdictions through cross-border sales, trafficking, or cannabis tourists driving back to their state of residence while impaired,” says lead author Tyler Lane, PhD, a postdoctoral research Fellow at Monash.

"Our findings suggest that policymakers should consult with neighboring jurisdictions when liberalizing cannabis policy to mitigate any deleterious effects."

Because the increase in fatalities was temporary, Lane believes it could be due to an initial “celebratory response to legalization” that contributes to cannabis tourism. His study was published in the journal Addiction.

Fatalities Drop in Medical Cannabis States

While fatalities rose in states with recreational cannabis, Lane notes that previous research has found a decrease in traffic fatalities in states that legalized medical marijuana. That may be because patients may be substituting cannabis for alcohol and other controlled substances used to relieve symptoms.

“There seem to be differences between medicinal and recreational user consumption patterns. Medicinal users have a tendency to substitute, but recreational users are more likely to treat alcohol and cannabis as complements and use them together,” Lane said in an email to PNN. 

“Because marijuana on its own is less impairing than alcohol, and combined used is much more impairing than either in isolation, it suggests that when people substitute alcohol for cannabis (in the medicinal use context), they will still be impaired, but to a much lower degree than if they were still using alcohol.” 

This “harm reduction role” of medical cannabis was noted in a 2016 Canadian study that found patients reduced their use of alcohol, illicit drugs and prescription drugs when cannabis was taken for medical reasons. 

Medical marijuana is currently legal in 33 states and Washington DC, and ten states allow its recreational use.

What Should You ‘Tell Your Children’ About Marijuana?

By Roger Chriss, PNN Columnist

Depending on your point of view, the new book “Tell Your Children: The Truth About Marijuana, Mental Illness, and Violence” is either a welcome cautionary tale about cannabis or a reincarnation of the infamous movie Reefer Madness.

Author Alex Berenson, a novelist and former reporter for The New York Times, is clearly no fan of cannabis legalization and the growing hype over its medical use.  

“Marijuana is not medicine. Marijuana and THC-extract products — whether eaten or smoked — are intoxicants and mild pain relievers, like alcohol,” he writes. “Marijuana in the United States has become increasingly dangerous to mental health in the last fifteen years, as millions more people consume higher-potency cannabis more frequently.”

Berenson argues that cannabis causes paranoia and psychosis, with more use leading to greater mental health issues and even violence.

He uses a combination of history and statistics as evidence, often with lurid reporting about cannabis and violent crime in the U.S. and Britain from over a century ago. Berenson describes incidents of psychotic breaks, murderous episodes, and heinous acts of violence that read a bit too much like true crime stories.

“Marijuana causes paranoia and psychosis. Psychosis causes violence. The obvious implication is that marijuana causes violence,” he writes, without offering any evidence linking the two.

Berenson then gives a brief history on the promotion of cannabis in the modern era by groups such as NORML, the Drug Policy Alliance and the magazine High Times. He emphasizes that the cannabis of the 1960s and ‘70s was “near beer” compared to the cannabis of today.

Berenson builds his case on the work of Swedish physician Sven Andréasson, who in the 1980s used data from the Swedish military draft to investigate the connection between cannabis and schizophrenia. Andréasson found that the use of cannabis was strongly correlated with schizophrenia and that the risk was dose-related.

To bolster his argument, Berenson draws on the work of Phil Silva in the Dunedin Multidisciplinary Health and Development Study; Robin Murray at the Institute of Psychiatry in London; and the 2017 National Academies report on cannabis.

The cannabis-schizophrenia connection has been overlooked, in part because of limited data. In Washington state, for example, where recreational cannabis was legalized in 2014, the state health department doesn’t even keep track of schizophrenia cases.

Berenson says legalizing cannabis for medical use is a cagey strategy to protect recreational users and gain public support for full legalization, because it “encourages voters to think of marijuana as something other than an intoxicant.”

“Medical marijuana is a way of protecting a subset of society from arrest,” he wrote, adding that “marijuana simply wasn’t a strong enough painkiller to be effective for most people who truly needed opiates.”

He even suggests cannabis legalization may be exacerbating the opioid crisis.

“What’s gone unnoticed in the discussion over state-by-state changes is the striking correlation between the opiate epidemic and cannabis use at the national level,” he said. “The direct economic benefits of legalization also appear to be vastly overrated.”

Berenson concludes with an ironic argument for more research: “The government should drop its barriers to researching cannabis for medical purposes. The reason is not that marijuana is likely to prove a miracle cure for cancer — or anything else. It’s precisely the opposite. Let’s put unfounded claims to rest, permanently.”

There are reasons to be skeptical of Berenson’s conclusions. He points to a lack of data on trends in serious mental illness as hiding the impact of cannabis on schizophrenia rates. But the lack of data means we don’t really know what is happening. Trends are further obscured by changes in diagnostic criteria, reporting requirements and treatment availability. All of this needs to be carefully teased out in regard to cannabis as a factor in schizophrenia.

Similarly, Berenson recognizes that no research proves cannabis causes psychosis and violence. He points out that such research is not ethically acceptable. But there are other ways to establish causation, including prospective longitudinal studies and natural social experiments such as Canadian legalization. In other words, Berenson may be able to claim he is right some day, but not yet.

Lastly, Berenson ignores the issue of scale. Even if the psychotic breaks and criminal acts he describes are attributable to cannabis, they are still very rare compared to the scale of cannabis use. He needs to establish a base rate and then show that increasing levels of cannabis use are associated with rising rates of psychosis and violent crime. That work remains to be done.

“Tell Your Children” is useful but could have been better. Berenson overreaches in his conclusions and omits important considerations. But he raises relevant questions about the potential mental health risks and social implications of cannabis. “Tell Your Children” may not be essential reading, but for people who are interested in the possible risks of cannabis, it is certainly worth reading.

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.

The Marijuana Ad You Won’t See During the Super Bowl

By Pat Anson, PNN Editor

The hype over Super Bowl LIII between the Los Angeles Rams and New England Patriots took a back seat this week to a debate over the benefits of medical marijuana.

The February 3 game is being broadcast by CBS, which rejected a 30-second Super Bowl ad by Acreage Holdings -- the cannabis company that recently hired former House speaker John Boehner as a spokesman. Along with the other broadcast networks, CBS currently does not accept any cannabis related advertising.

The Acreage ad features 3 cannabis users -- a boy who suffers from epilepsy, a man who took opioid medication for 15 years for back pain, and a military veteran who suffers from phantom limb pain after losing a leg in the service. The ad doesn’t promote Acreage products, but urges viewers to call their congressional representatives and advocate for medical marijuana.

“We’re disappointed by the news but somewhat unsurprised,” Acreage President George Allen told CNN Business. “Still, we developed the ad in the spirit of a public service announcement. We feel it’s our responsibility to advocate on behalf of our patients.”

The chief marketing officer for Acreage was less diplomatic.

“You will see countless ads (during the Super Bowl) for beer and erectile dysfunction medications but our ad with an educational goal to help people who are suffering is rejected. That is the irony we are looking to highlight,” Harris Damashek told the Green Entrepreneur.

A 30-second ad during the Super Bowl would have cost Acreage over $5 million, but the company is getting a lot of free publicity over the controversy.  A 60-second version of the ad was posted on YouTube.

Medical marijuana is legal in 33 states and Washington DC, but remains illegal under federal law. Although cannabis is a banned substance in the NFL, many current and former players use it for pain relief.

“When you compare it to what the alternative is in their training rooms; pills, pills, pills, that are being put into these guys’ hands and turning them into addicts,” former NFL player Nate Jackson told PNN. “I was never big on those pills. I medicated with marijuana and it helped me and I think it helped save my brain.”

Although the NFL has a reputation as a league that closely monitors and disciplines players for illegal drug use,  Jackson estimates over half its players currently use marijuana to relieve pain and stress after games.

Survey: Most Medical Cannabis Users Drive While High

By Pat Anson, PNN Editor, and Shefali Luthra, Kaiser Health News

With medical marijuana now legal in nearly three dozen states – and ten allowing its recreational use – state governments face two difficult questions: Are more people driving under the influence of marijuana? And at what point are they too impaired to drive?

The answer to the first question is troubling and the second one is elusive. 

According to a new survey, over half the people who take medical cannabis for chronic pain say they've driven under the influence of cannabis within two hours of using it.  And one in five say they've driven while “very high.”

Researchers at the University of Michigan Addiction Center surveyed 790 Michigan adults who sought medical cannabis certification for chronic pain in 2014 and 2015. The researchers asked about their driving habits over the past six months.

Fifty-six percent reported driving within two hours of using cannabis, 51% said they drove while a "little high" and 21% reported driving while "very high."

"We want people to know that they should ideally wait several hours to operate a vehicle after using cannabis, regardless of whether it is for medical use or not," said Erin Bonar, PhD, a psychiatry professor, clinical psychologist and lead author of the study published in the journal Drug & Alcohol Dependence. "The safest strategy is to not drive at all on the day you used marijuana."

The survey found that patients with higher pain levels were less likely to to drive while impaired. But Bonar says the overall risk of impairment could be higher for chronic pain patients who use medical marijuana daily and have trace amounts of tetrahydrocannabinol (THC) lingering in their system. THC is marijuana’s main psychoactive ingredient.

"When it comes to driving, we haven't yet figured out the best way to know how impaired marijuana users are at any given time," she says. “It's hard to quantify because there is a lot of variation in marijuana dosing, THC potency, and route of administration. We also don't have specific guidelines yet about when exactly it would be safe to operate a vehicle.

"We also need clearer guidelines about marijuana dosing and side effects with an understanding of how individual differences in things like sex and body weight interact as well."

The study was funded by the National Institute on Drug Abuse.

Measuring Impairment

Brain scientists, pharmacologists and law enforcement are still learning how measure if and to what extent marijuana causes impairment.

Blood and urine tests can detect marijuana use, but because traces of the drug stay in the human body for a long time, those tests can’t specify whether the use occurred earlier that day or that month. They also don’t indicate the level at which a driver would be considered under the influence.

“It’s a really hard problem,” said Keith Humphreys, PhD, a psychiatry professor and drug policy expert at Stanford University in California, the first state to legalize medical marijuana and where recreational cannabis use among adults became legal in 2016. “We don’t really have good evidence — even if we know someone has been using — what their level of impairment is.”

For alcohol, there is a clear, national standard for impairment. If your blood alcohol content is 0.08 percent or higher, you’re considered cognitively impaired at a level that is unsafe to drive.

Extensive research supports this determination, and the clarity makes enforcement of drunk driving laws easier.

Setting a marijuana-related impairment level is a murkier proposition. And states that have legalized cannabis have to figure it out, experts said.

“You can’t legalize a substance and not have a coherent policy for controlling driving under the influence of that substance,” said Steven Davenport, an assistant policy researcher at the nonprofit Rand Corp., who specializes in marijuana research.

With marijuana going mainstream around the country, regulators are “playing catch-up,” according to Thomas Marcotte, a psychiatry professor at the University of California-San Diego and one of a number of academics who is researching driving while high.

States have put forth a bevy of approaches. At least five outlaw driving if someone’s blood level of THC exceeds a certain amount. Colorado, where voters approved recreational marijuana in 2012, has this type of driving law on the books. But it took three years to pass amid fiery debate and deems “intoxicated” any driver who tests higher than 5 nanograms of THC per milliliter of blood.

Rhode Island, Pennsylvania and Indiana are among states that forbid driving at any THC level.

Still others say drivers should be penalized only if they are impaired by THC -- a standard that sounds reasonable but quickly gets difficult to measure or even define.

None of these approaches offers an ideal solution, experts say. “We’re still definitely evaluating which policies are the most effective,” said Ann Kitch, who tracks the marijuana and driving issue for the National Conference of State Legislatures.

States that set a THC-level standard confront weak technology and limited science. THC testing is imprecise at best, since the chemical can stay in someone’s bloodstream for weeks after it was ingested. Someone could legally smoke a joint and still have THC appear in blood or urine samples long after the high passes.

There’s general agreement that driving while high is bad, but there’s no linear relationship between THC levels and the degree of impairment. States that have picked a number to reflect when THC in the bloodstream becomes a hazard have “made it up,” argued Humphreys.

“The ones who wrote [a number] into legislation felt they had to say something,” he said. But “we don’t know what would be the analogy. Is the legal amount [of THC] equal to a beer? Is that how impaired you are? Is it a six-pack?”

Roadside testing for THC is also logistically difficult. Blood and urine samples need to be collected by a medical professional and analyzed in a lab.

In Canada, where recreational cannabis was legalized last year, law enforcement will test drivers with a saliva test called the Dräger DrugTest 5000. But that isn’t perfect, either.

Some private companies are trying to develop a sort of breathalyzer for marijuana. But Jonathan Caulkins, a drug policy researcher at Carnegie Mellon University, said, “There are fundamental issues with the chemistry and pharmacokinetics. It’s really hard to have an objective, easy-to-administer roadside test.”

Until a reliable system is found, states are relying on law enforcement to make a subjective assessment of whether someone’s driving appears impaired by marijuana.

In California, every CHP officer learns to administer field sobriety tests — undergoing an extra 16 hours of training to recognize the influence of different drugs, including marijuana. Because medical marijuana has been legal there since 1996, officers are “very used” to recognizing its influence, says Glenn Glazer, the state’s coordinator for its drug recognition expert training program.

That kind of training is taking off in other states, too. Lobbying groups such as Mothers Against Drunk Driving are pushing for more law enforcement training to help officers assess whether a driver is impaired.

In the meantime, the public health threat is real. States with legalized cannabis appear to have more car crashes, though the relationship is muddled.

“This is going to be a headache of an issue for a decade,” Caulkins said.

Kaiser Health News is a nonprofit news service covering health issues. It is an editorially independent program of the Kaiser Family Foundation, which is not affiliated with Kaiser Permanente.

Precautions Needed for Medical Cannabis

By Roger Chriss, PNN Columnist

Medical cannabis continues to thrive. Older Americans are flocking to cannabis dispensaries and more states are considering legalization or adding approved indications.

But there is relatively little information about the potential risks and pitfalls of medical cannabis. The New York Times reports that “researchers are uneasy about the fact that older people essentially are undertaking self-treatment, with scant guidance from medical professionals."

There are three broad categories of precautions that people who are using or considering medical cannabis should be aware of.

Product Quality and Reliability

Reliably sourcing a high-quality cannabis product can be difficult. Product labels are often inaccurate. A 2015 survey of cannabis edibles in Seattle, San Francisco and Los Angeles found that only 13 of the 75 products tested (17%) had labels that accurately indicated their THC content.

More recent testing in California found that about a quarter of the cannabis-infused cookies, candies and tinctures failed safety tests because of improper labeling or because they contained pesticides.

One lab in Sacramento was even found to be falsifying test results. A spokesman for the California Cannabis Industry Association said it's an open secret in the industry that companies have been paying for favorable test results.  

States from Massachusetts to Nevada are also seeing problems with pesticides, mold and heavy metals contaminating medical-grade cannabis.

DRUG POLICY ALLIANCE

Interactions and Contraindications

Cannabis consists of over 100 cannabinoids, as well as other physiologically active substances. This makes for a lot of possible drug interactions. Drugs.com lists 129 major and 483 moderate interactions that cannabis can have with medications such as acetaminophen, codeine, fentanyl, hydrocodone, pregabalin and oxycodone.

Moreover, cannabis has been found to reduce thyroid stimulating hormone (TSH) levels. For people with thyroid disease, artificially suppressed TSH can affect medication decisions. Similarly, cannabis reduces platelet aggregation, a problematic and even risky issue for people with bleeding disorders or low platelet counts.

A new review in Current Opinion in Neurology found that cannabis exacerbates tinnitus (ringing of the ears), a common problem for older people and people with Meniere’s disease or Charcot-Marie-Tooth disease.

Tolerance and Withdrawal

Cannabis tolerance may be a clinically significant issue. A new study on CBD oil for seizure management found that cannabidiol loses its effectiveness in treating epilepsy. About one-third of patients in the study stopped taking CBD because of a lack of benefits or side effects like sleepiness and gastrointestinal trouble.

“CBD is a good option for children and adults with certain kinds of epilepsy, but as with anti-epileptic drugs (AEDs), it can become less effective over time and the dose may need to be increased to manage the seizures,” said lead author Shimrit Uliel-Sibony, MD, head of the pediatric epilepsy service at Tel Aviv Sourasky Medical Center.

Also important is withdrawal. Recent research on cannabis withdrawal in a group of chronic pain patients found that about two-thirds reported at least one moderate or severe withdrawal symptom. Withdrawal symptoms included sleep difficulties, anxiety, irritability and appetite disturbance.

In sum, there are important issues to address when using or considering medical cannabis. Unfortunately, knowledgeable physicians are hard to find and high-quality cannabis is difficult to obtain reliably. It is hoped that this will change soon so that medical cannabis can be used safely and effectively.

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.

Cannabis Gave Me Hope in My Darkest Hour

By Mia Maysack, PNN Columnist

I've lived most of my life with an ongoing migraine -- often trapped in a hazy brain fog induced by prescription medication.  

Suggestions of all kinds of alternatives have been made to me, including cannabis. But it wasn't until my very first headache cluster – which lasted 54 straight days -- that I gave in and the medicinal use of this miracle drug saved my life.

At that point, I hadn't slept in an inhumane amount of time, wasn't able to work, participate in life, or keep food and drink down. Then a friend literally begged me to "take a hit."

Call me a square, but I didn’t take a sip of alcohol until my 21st birthday and had never used marijuana or had the desire to.  What did I have to lose?

I had tried everything else. My arms were still bruised from IV's at the ER. So with absolutely no more craps to give, I lit up.  And almost instantaneously felt better.

I spent a lot of time battling shame for breaking the law and the stigma of marijuana use. But I've evolved to accept my truth. Marijuana is not a gateway drug, unless a person makes the choice to escalate their substance use. No treatment option is meant to be approached as a cure, nor should it be a crutch.   

Marijuana can be ingested in multiple ways, there are countless strains and products without the THC itself -- although that's the key element that eases my ailments. It helps me combat nausea, cultivate an appetite, gives a slight boost in morale, and get quality rest.  

Cannabis works for me about half the time.  But that goes deeper than a glass half empty or half full.  It's a matter of having a resemblance of a life or not.   

There have been no overdoses or deaths reported from this natural plant. Over two dozen states, as well as our nation's capital, have adapted to the reality that it can be used as medicine.  It has saved and made A LOT of money, lowered criminal activity and rescued many others aside from myself.  

If someone had told me one day I'd be writing about marijuana for the world to see, I wouldn't have believed them.  But my public, unapologetic declaration is that cannabis provided a glimmer of hope during my darkest hour.  I share this not to promote it or advise anyone else, but because I want to raise awareness and demonstrate the courage to step out of your comfort zone.   

I've wounded relationships over this stuff, because not everyone can wrap their minds around it. I've also gotten in a bite sized amount of trouble over it -- munchie pun fully intended. It’s not for everyone but there are good reasons ill patients are being granted access to it. There’s research to support marijuana being helpful in attacking the opioid crisis, both for those struggling with addiction as well as those who are prescription dependent.    

How a person chooses to conduct themselves is a matter of free will. It has nothing to do with whether a CBD oil extract or pot brownie helps them get out of bed in the morning. It’s a matter of self-accountability and self-care. Cannabis saved my life.  

Mia Maysack lives with chronic migraine, cluster headaches and fibromyalgia. Mia is the founder of Keepin’ Our Heads Up, a Facebook advocacy and support group, and Peace & Love, a wellness and life coaching practice for the chronically ill.

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.

New Cannabis Studies for Pain Management Underway

By Roger Chriss, PNN Columnist

Clinical trials of cannabis are quickly ramping up. Legalization of cannabis in Canada is leading to new studies of cannabis for pain management. And the recent legalization of medical cannabis in Utah and Missouri underscores the growing consumer and commercial interest in cannabis and the need for proper clinical research.

The National Academies of Science last year released a report stating that cannabis can be effective for managing some forms of chronic pain. But the report also acknowledged there is a limited evidence base to support the use of cannabis in pain management.

So, while it is trite to observe that enthusiasm for cannabis may be running ahead of science, it is important to note how quickly this is changing. We will soon know more about what cannabis is useful for medically, as well as when and how to use it clinically.

For instance, a new clinical trial is getting underway in Canada to look at inhaled cannabis versus fentanyl buccal (sublingual) tablets for managing pain in cancer patients.

This is a Phase II trial with two goals. First, an open-label randomized study to evaluate the effects of cannabis versus fentanyl in adults with breakthrough cancer pain who are already on opioids. Second, a randomized double-blind placebo-controlled trial to evaluate the effect of cannabis or fentanyl as compared to a placebo group with breakthrough cancer pain.

“Medical cannabis may help reduce the use of drugs like fentanyl for treating breakthrough and chronic pain,” said Dr. Guy Chamberland, CEO of Tetra Bio-Pharma, which is running the trial. “However, unrefuted scientific data on its safety and effectiveness that will satisfy regulators, professional groups and insurers is what’s missing.”

This will be the first trial to compare cannabis and opioids in a head-on fashion. Though it is specific to breakthrough cancer pain, it may provide insight into what the strengths and limitations of cannabis are in other types of pain management.

Another trial is looking at CBD oil for managing chronic non-cancer pain. It is sponsored by Hamilton Health Sciences Corporation and the Michael G. DeGroote Institute for Pain Research and Care at McMaster University in Canada. This is also a Phase II trial that seeks to determine whether CBD alone or a combination of CBD and THC reduces the pain of patients with chronic non-cancer pain. The trial will assess pain reduction and associated symptoms, as well as reductions in the use of other medications.

According to the trial protocol, participants will be randomly selected to receive up to 80mg of CBD in capsules for 12 weeks. The doses are many times greater than the commercial CBD oils, edibles and other products that are available over-the-counter, so this trial should help clarify how much CBD is needed to treat pain.

Research is underway in the United States as well, in particular at places like the UCLA Cannabis Research Initiative and at Washington State University. The results of these and other trials will enable sound clinical decisions for cannabis in pain management. At present, a lack of information hampers clinicians.

This was demonstrated in a recent article in The New England Journal of Medicine that looked at the pros and cons of using medical cannabis to treat a woman with Complex Regional Pain Syndrome.  Even the doctor who wrote in favor of cannabis admitted “high-quality evidence is limited” on its effectiveness as a pain reliever, although experiments on animals “provide reassuring support on safety.”

The studies now underway will better inform doctors about such decisions and reduce uncertainty.

Cannabis deserves good science. The changing legal landscape in Canada and the United States is providing research opportunities that will help clarify what cannabis may be useful for and how best to use it.

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 Funding Study of Cannabis as Opioid Alternative

By Pat Anson, PNN Editor

Columbia University has been awarded a grant from the National Institute on Drug Abuse (NIDA) to investigate whether medical cannabis can reduce the use of opioids and overdose risk in chronic pain patients.  

The grant was awarded after researchers with Columbia Care completed a small pilot study that found nearly two-thirds of patients with chronic nerve pain were able to reduce or stop their opioid use. Columbia Care is a private medical marijuana company not affiliated with the university that operates a chain of cannabis dispensaries around the country.

“There is an urgent need to investigate the potential impact of cannabinoid use on limiting opioid overdose risk and to determine whether specific products are more beneficial for certain populations of patients with pain and opioid use,” said Arthur Robin Williams, MD, a professor in the Division on Substance Use Disorders in the Columbia University Department of Psychiatry.

The pilot study involved 76 neuropathy patients in New York State who were given Columbia Care’s dose-metered cannabis products for nine months. By the end of the study, 62 percent of the patients were able to reduce or stop using opioid pain medication.

Columbia Care makes a variety of medical cannabis products that come in tablets, tinctures, suppositories, topical formulations or can be used in vaporizers. 

“We have seen through this pilot study the power of our proprietary formulations to reduce our patients’ dependence on opioids in a defensible, scientific manner,” said Rosemary Mazanet, MD, chief science officer and chair of the scientific advisory board at Columbia Care.

DRUG POLICY ALLIANCE

Although medical marijuana is often touted as a possible solution to the nation’s opioid crisis, research findings so far have been mixed.

A recent study by the RAND Corporation found little evidence that states with medical marijuana laws see reductions in legally prescribed opioids. While some pain patients may be using or experimenting with medical marijuana, RAND researchers do not believe they represent a significant part of the opioid analgesic market.

"If anything, states that adopt medical marijuana laws... experience a relative increase in the legal distribution of prescription opioids,” researchers found.

Another study of Medicare and Medicaid patients found that prescriptions for morphine, hydrocodone and fentanyl dropped in states with medical marijuana laws, while daily doses for oxycodone increased. A second study found a 6% decline in opioid prescribing to Medicaid patients in states with medical marijuana laws.  Both studies were conducted during a period when nationwide opioid prescribing was already in decline.

A 2014 study published in JAMA Internal Medicine found that opioid overdoses declined by nearly 25 percent in states where medical marijuana was legalized.

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. 

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.

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.

UK and Canada Legalizing Cannabis

By Pat Anson, PNN Editor

There’s a lot of hype this week about Canada becoming the second and largest country to legalize recreational marijuana. The first was Uruguay.

But the bigger news for the pain community may be in the United Kingdom, which has some of the strictest marijuana laws in Europe. Home Secretary Sajid Javid made a surprise announcement last week that medical cannabis products would be rescheduled on November 1 and become available by prescription to treat chronic pain, epilepsy and chemotherapy-induced nausea.

Javid agreed to review the scheduling of medical cannabis in June, after a public outcry over the seizure of CBD oil flown into Heathrow Airport for a 12-year old boy who has epilepsy. Although the oil primarily contained cannabidiol – the non-psychoactive ingredient in marijuana – it was still technically illegal under UK drug laws.

“I stressed the importance of acting swiftly to ensure that where medically appropriate, these products could be available to be prescribed to patients,” Javid said in a statement.

“I have been clear that this should be achieved at the earliest opportunity whilst ensuring that the appropriate safeguards were in place to minimise the risks of misuse and diversion.”

Javid was also clear he has no intention of supporting the legalization of recreational marijuana in the UK. Smoking cannabis in any form will also remain illegal. Even so, it was a big step forward for marijuana supporters..  

“This is a major victory for our campaign and will mean a lot of people will have a much better quality of life,” Clark French, a multiple sclerosis patient and cannabis activist, told Leafly.

“It does look that this could be the most open, accessible medical cannabis policy in Europe, if they get it right and we keep guiding them in the right directions,” said Jon Liebling of United Patients Alliance, a medical marijuana advocacy group.    

The rollout of CBD-based medicines in the UK will go slowly. It could take up to a year before the National Health Service comes up with guidelines to govern the distribution of CBD-based products. Initially, only medical specialists will be allowed to prescribe cannabis, although the guidelines are expected to eventually include general practitioners.

Activists are urging the Home Office to allow medical cannabis for all patients, not just those with pain, epilepsy or nausea.

“We do believe that everybody should have access,” said Liebling. "When you're talking about cannabis as a medicine, you really do have to compare the risks associated with cannabis that we're aware of versus the risks of those drugs that patients are already taking.” 

Legalization Worries Canadian Medical Association

Medical cannabis has been legal in Canada since 2001 and about 330,000 Canadians are registered and already have access to it.  But some health officials are less than enthused about the October 17 legalization of recreational cannabis.

"Given the known and unknown health hazards of cannabis, any increase in use of recreational cannabis after legalization, whether by adults or youth, should be viewed as a failure of this legislation," wrote Dr. Diane Kelsall, interim Editor-in-Chief, in an editorial in the Canadian Medical Association Journal.

Kelsall points to the stampede of Canadian and American companies looking to get into the cannabis industry and predicts many will brazenly advertise their products to young people.

“Cannabis companies may initially focus on attracting current consumers from black-market sources, but eventually, to maintain or increase profits, new markets will be developed as is consistent with the usual behaviour of a for-profit company. Marketing efforts may include encouraging current users to increase their use or enticing a younger demographic. The track record for tobacco producers has not been encouraging in this regard, and it is unlikely that cannabis producers will behave differently,” Kelsall warned.

Kelsall said the Canadian government needs to carefully track cannabis use and should have the courage to amend the law if problems arise.

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.”

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.

Medical Cannabis to Be Studied in Nursing Homes

By Pat Anson, PNN Editor

Plans have been announced in Canada for a research study on the effectiveness of medical cannabis in treating pain and improving cognitive function in seniors. The 6-month pilot program will be one of the largest of its kind, enrolling up to 500 nursing home residents.

The Ontario Long Term Care Association (OLTCA) is partnering with Canopy Growth Corporation, which makes a variety of cannabis products through its Spectrum Cannabis brand. The pilot study will focus on evaluating the impact of medical cannabis on residents’ health and quality of life, as well as caregiver stress and the economic benefits of cannabis use in nursing homes.

"Medical cannabis is currently prescribed for residents as appropriate, but it's still an emerging area," says Candace Chartier, CEO of OLTCA, which represents over half of Ontario's 630 long-term care homes.

"Through this partnership and pilot study, we hope to provide more clarity to long-term care clinicians and frontline staff about the use of medical cannabis for residents."

Can cannabis improve cognitive function? The popular image of clueless stoners breezing through life like Jeff Bridges as the Dude in “The Big Lebowski” may not be entirely accurate.

A small 2016 study by researchers at Harvard Medical School and Tufts University found that cognitive function improved in 24 adults who smoked marijuana for three months. Participants also reported better sleep, less depression and a significant decrease in their use of medications such as opioids — all qualities that would be welcomed in nursing homes.

"There is clearly an interest in the long-term care space to explore medical cannabis as an alternative to traditional medications for pain and degenerative cognitive function," said Mark Zekulin, President & Co-CEO of Canopy Growth. "The pilot study we've announced… is the first step in developing an evidence-based, best practice approach to medical cannabis that will result in consistent care for thousands of seniors and ultimately improve quality of life and outcomes in long-term care homes."

A recent survey in Israel of over 2,700 elderly patients found that medical cannabis significantly reduced their chronic pain.  About a third of the patients used CBD oil, about 24 percent smoked marijuana, and about six percent used a vaporizer.

Over half of the seniors who originally reported "bad" or "very bad" quality of life said their lives improved to "good" or "very good."

"We found medical cannabis treatment significantly relieves pain and improves quality of life for seniors with minimal side effects reported," said Victor Novack, MD, a professor of medicine at Ben-Gurion University and head of the Soroka Cannabis Clinical Research Institute.

A recent survey by the American Association of Retired Persons (AARP) found that most older Americans think marijuana is effective for pain relief, anxiety and nausea.

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).”

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.

Coke Considering Cannabis Drinks

By Pat Anson, PNN Editor

These are heady times in the beverage industry, with dozens of companies introducing cannabis-based drinks – from sparkling water to herbal teas to cold brew coffee. After decades of being ostracized on Main Street and Wall Street, marijuana is suddenly trendy.

The largest beverage company in the world – Coca-Cola -- is even thinking about entering the rapidly growing cannabis market. According to BNN Bloomberg, Coke is in serious talks with Aurora Cannabis of Canada to develop a cannabis-infused beverage that would be marketed as a “recovery drink” that eases inflammation, pain and muscle cramps.  

It’s not clear if Coke is interested in a joint venture with Aurora or if it would buy a stake in the Edmonton-based company. Coke said it would not comment on “speculation.”

“We have no interest in marijuana or cannabis. Along with many others in the beverage industry, we are closely watching the growth of non-psychoactive CBD as an ingredient in functional wellness beverages around the world. The space is evolving quickly. No decisions have been made at this time,” Coke said in a statement.

Could a CBD-infused drink provide pain relief? Marijuana researcher Yasmin Hurd, PhD, told NBC News it's unlikely that a beverage made with CBD could have health benefits because a high dose of about 200 milligrams is needed to be effective.

“CBD gets broken down and metabolized quickly in the body,” said Hurd, who is director of the Addiction Institute at Mount Sinai Hospital. “The amount that would get in the bloodstream from a drink would not have an effect.”

The efficacy of CBD-infused drinks may not be proven, but the potential profits are. According to a new report by Ameri Research, the global medical cannabis market was valued at $8.9 billion in 2016 and is projected to grow to nearly $33 billion by 2024.

Twenty-eight U.S. states currently allow the sale of medical marijuana, while 9 states allow recreational sales. Marijuana is still illegal at the federal level, but products made from cannabidiol (CBD) – the non-psychoactive ingredient in marijuana – are being sold in all 50 states.

Canada already permits medical usage and next month recreational use will be legalized nationwide. Because of that, several beverage makers besides Coke are interested in partnering with Canadian cannabis companies.

Last month, Corona beer brewer Constellation Brands announced it would spend $3.8 billion to increase its stake in Canopy Growth, a Canadian marijuana producer. Molson Coors Brewing is starting a joint venture to develop cannabis drinks in Canada. And Heineken has launched a craft-brew label specializing in non-alcoholic drinks infused with THC, the psychoactive ingredient in marijuana.

“Interest has spiked from the beer industry on mounting evidence of a substitution relationship between cannabis and alcohol, while large soda companies increasingly view CBD as a natural fit within their strategically important wellness offerings,” wrote Canaccord Genuity analyst Bobby Burleson in a research note.

Canaccord projects that CBD and THC infused drinks could become a $600 million market in the U.S. within the next four years.

“Medical and wellness benefits include suppression of seizures, pain relief, reduction of anxiety and a host of other therapeutic effects,” said Burleson. “We note that that the medical benefits of CBD have recently been bolstered by the FDA’s approval of Epidiolex, a CBD based drug developed to treat epilepsy. It follows that CBD also offers significant potential as the basis for a wellness beverage.”