What Are Health Risks of Vaping CBD?

By Roger Chriss, PNN Columnist

An outbreak of lung illnesses linked to vaping is raising important questions about the safety of vaping cannabis products. The cause is still unclear, but the CDC reports about 76% percent of the patients who became ill vaped products containing THC – the psychoactive ingredient in cannabis. Only about 17% reported vaping a cannabidiol (CBD) product.

At present, very little is known about CBD vaping safety. The World Health Organization’s 2017 report on cannabidiol looked at oral, sublingual and intranasal routes of administration. When the WHO wrote that “CBD is generally well tolerated with a good safety profile,” it was not considering vaping at all.

The Food and Drug Administration still considers CBD in food and drugs sold commercially to be illegal, unless the product falls under the Food, Drug and Cosmetic Act. Vaping CBD does not, and so there has been no testing or regulatory action.

There have been no good human studies on CBD vaping. Research generally looks at CBD in edibles and liquids, or smoked using traditional means.

It is not known what happens to CBD under vaping temperatures, if there are thermal degradants, or important chemical reactions between CBD and other ingredients in vaping liquids or other drugs.

A recent lung tissue study found concerning results about inhaling CBD while using steroids. CBD helps reduce inflammation, but “acts as an antagonist with steroids, overriding the anti-inflammatory potential of steroids when used in combination.”

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Last year Vice reported on public health warnings in North Carolina after 90 people became sick with headaches, nausea, hallucinations and other health problems after vaping CBD products. Adulterants appear to have been the problem, and Vice noted that vape oils are poorly regulated and sometimes contain chemicals that “when heated in a vape and inhaled, can cause serious lung irritation.”

A recent study on the quality of CBD liquids used in e-cigarettes is also concerning, finding that “the quality control of manufacturers and the relative safety of these products is uncertain.”

An AP investigation last month found that in lab tests on 30 CBD vape products, ten samples contained synthetic marijuana such as K2 or spice, while others had no CBD at all.

Some states with legalized cannabis do require testing of CBD vapes. But it’s not clear what to test for, and even the lab methods for testing have yet to be validated. It is also not known which cutting agents, adulterants and contaminants should be cause for concern. Lung tissue is fragile, vulnerable in ways the GI tract is not, and not well studied. So testing regimes may ultimately require information we currently lack.

Oversight of cannabis testing is limited. California’s Sequoia Analytical Labs was found to be falsifying lab results last year. Plus, many CBD vapes come from the gray or black markets, or are home-brewed, making attempts at quality control irrelevant. As a result, CBD vaping safety is an open question, assuming it is even possible to make a safe CBD vape.

Fortunately, new research may help. Researchers are testing vaporized cannabis extracts on rats. This will allow for studying the effects of THC and CBD in animal models in a way that closely mimics human behavior.

Such information is urgently needed. Animal studies on vaping are raising concerns about lung cancer risk, but such research may not be representative of how humans vape, limiting their value.

There is ongoing debate on what CBD is good for. And now we also have to consider how CBD should be administered. It may be possible to create a low-risk CBD vape product. But at present we don’t really know how to do it.

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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 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.

Green Without Envy

By Mia Maysack, PNN Columnist

In the opinion of some, at various points in my life I could've been considered a "pothead." 

If that is how you refer to the medicinal use of a plant that grows freely in nature, I own the judgement with pride.  

I've known people who sit around and smoke loads of grass to the point of everything being funny -- but they're too stoned to laugh. That has never been my intent or relationship with marijuana.

This is another element of living with chronic pain and illness that is severely misunderstood -- the desperation we feel for relief.  After you've tried countless traditional approaches to no avail or improvement, I don't care what anyone says. Every single person reaches their absolute limit or breaking point.

When others have discovered that marijuana is part of my care plan, I've been shunned and labeled as a drug addict by the very same people who puff cigarettes, drink alcohol into oblivion, cannot get through a day without coffee, and poison themselves with food-like-products from a drive-thru window.  

Please explain how a man-made drug produced in a lab is somehow safer than marijuana. The only difference is that the drug is regulated and thereby taxed. Arguably, that’s what all of this is about: Money.  

I haven't come across anything that eases my head or body pain. I have only been able to accumulate a short list of helpful remedies that can temporarily (but not always) assist in my co-existence with pain. 

For example, marijuana helps combat nausea, which aids with proper nourishment and hydration. And when you haven’t had a good night’s sleep in days or weeks, a marijuana-induced state of relaxation can mean the difference between restful sanity or a trip to the loony bin.  

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There will always be people who abuse whenever they get an opportunity, in the same way that every church has sinners and one bad pizza doesn't mean all pizza joints are bad. The unfortunate choices of a few should not outweigh the credibility of many.

When I ingested my first opioid, it lifted the agony in a way I had never experienced before. I remember like it was yesterday. I thought for sure I was too sick to make it into work but chose to attempt this pill, solely out of desperation. It left me smiling ear-to-ear on my way to my beloved nursing job.

But as I pulled into the parking lot, I was struck with an overwhelming wave of sickness and could barely make it to the trash can before completely losing it. I had an allergic reaction to opioid medication and another potential treatment was biting the dust. 

I do not touch the stuff anymore, but that doesn't change the fact that opioids have proven to be extraordinarily helpful for a countless amount of people. And these same people who were given legitimate prescriptions are now being punished by having their medication taken away, often without a follow up plan or any notice. 

Healthcare providers are balancing on a sensitive tight rope between doing no harm while attempting to avoid ruining their good legal standing or that of their practice. This is causing many patients to feel abandoned, lost and isolated, with low quality of life and high suicide rates.

Peering into the window of someone else's life and judging them simply because you don't understand their thoughts, experiences or desperation is unacceptable.

It's easy to be judgemental and not care about the crisis in pain care if you or a loved one hasn't been personally affected by it. But this is a general societal crisis that affects young and old, rich and poor. Someday it will affect you.

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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.

Feds Warn CBD Marketers Again

By Pat Anson, PNN Editor

The Federal Trade Commission (FTC) has warned three companies that sell cannabidiol (CBD) oils, tinctures, edibles and other products to stop making claims that CBD can be used to treat pain and other chronic illnesses.

In letters to the companies, which the FTC is not identifying, the agency warned that it is illegal to advertise that a product can prevent, treat or cure illnesses without scientific evidence to support such claims.

One company’s website claims CBD “works like magic” to relieve “even the most agonizing pain.” Another company advertises CBD as a “miracle pain remedy” for both acute and chronic pain, including pain from cancer treatment and arthritis.

The FTC said the third company’s website promotes CBD gummies as highly effective at treating “the root cause of most major degenerative diseases, including arthritis, heart disease, fibromyalgia, cancer, asthma, and a wide spectrum of autoimmune disorders.” The company also claims its CBD creams and oils can relieve arthritis and fibromyalgia pain.

“In the letters, the FTC urges the companies to review all claims made for their products, including consumer testimonials, to ensure they are supported by competent and reliable scientific evidence,” the agency said in a statement.

The letters also warn that selling CBD products without substantiation could violate the FTC Act and may result in legal action. The companies were given 15 days to respond.

In March 2019, the FTC and Food and Drug Administration sent similar 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 products.

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Nutra Pure, which makes a line of hemp oil, now has a lengthy disclaimer on its website stating that its products “have not been evaluated” by the FDA and that they “are not intended to diagnose, prevent, treat, or cure any disease.”

But when we posed as a customer in an online chat with “Kristen,” a NutraPure representative, we were assured that hemp oil can treat pain.  

Customer: “Do your products help treat pain?”

Kristen: “There are numerous studies showing CBD has the ability to provide therapeutic benefits in the treatment of various conditions, including chronic pain, arthritis, anxiety/depression, nausea, epilepsy, fibromyalgia, glaucoma and many other ailments.”

Customer: “Which one of your products helps treat fibromyalgia?”

Kristen: “We recommend starting with our 300 or 600 mg bottle.”

Customer: “Will that help joint pain?”

Kristen: “They are like an all in one type product.”

Customer: “What does that mean?”

Kristen: “One product helps with all types of conditions.”

Customer: “Including pain?”

Kristen: “Yes.”

CBD is a non-psychoactive chemical compound derived from the cannabis plant. Much of it comes from hemp – a less potent strain of marijuana – that was legalized under the 2018 Farm Bill. There are literally thousands of CBD products on the market being sold online and over-the-counter without a prescription, often with dubious claims about their health benefits.

FDA and FTC enforcement actions against CBD marketers are sporadic and have usually only targeted small companies. But an FDA warning letter in July to Curaleaf, a Massachusetts company that sells CBD products nationwide, had an immediate impact on one large retailer. CVS Pharmacy pulled most Curaleaf products from its stores.

Study: Cannabis Flowers Rich in THC More Effective for Pain Relief

By Pat Anson, PNN Editor

Another study by researchers at the University of New Mexico suggests that tetrahydrocannabinol (THC) -- the psychoactive ingredient in marijuana – should not be ignored as a treatment for chronic pain.

In an unconventional survey of nearly 3,000 cannabis users, researchers found that those who used whole cannabis flowers or buds rich in THC reduced their pain levels an average of three points on a 0 to 10 pain score. Those who ingested cannabidiol (CBD) did not experience similar pain relief.

The researchers relied on information collected from the Releaf App, a mobile software program they created that allows cannabis users to self-report their experiences using different cannabis products, including flowers, edibles, tinctures and ointments.. Their findings are published in the journal Complementary Therapies in Medicine.

"Perhaps the most surprising result is just how widespread relief was with symptom relief reported in about 95 percent of cannabis administration sessions and across a wide variety of different types of pain," said Xiaoxue Li, PhD, an assistant professor of economics at UNM.

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"Cannabis likely has numerous constituents that possess analgesic properties beyond THC, including terpenes and flavonoids, which likely act synergistically for people that use whole dried cannabis flower," added Jacob Miguel Vigil, PhD, a professor in UNM’s Department of Psychology. "Cannabis offers the average patient an effective alternative to using opioids for general use in the treatment of pain with very minimal negative side effects for most people."

The authors caution that cannabis use does carry the risk of addiction and short-term impairment in cognitive and behavioral functioning.

“Cannabis with high THC also causes mood elevation and adjusts attentional demands, likely distracting patients from the aversive sensations that people refer to (as) pain," explains Vigil.

Previous studies using data from the Releaf app found that cannabis also provides relief from insomnia, seizures, depression, anxiety and fatigue. Despite conventional wisdom, THC was found to be more important than CBD in generating therapeutic benefits.

A significant weakness of the app is that it relies on cannabis users to subjectively self-report their experiences outside of a clinical setting. There is also no way to measure the quality or quantity of the cannabis they are ingesting.   

Two-Thirds of Americans Accept Cannabis as Pain Treatment   

Another new survey – conducted by the American Society of Anesthesiologists (ASA) – found wide acceptance of cannabis as a possible treatment for pain. The online survey 1,005 adults was conducted earlier this month.

More than two-thirds of those surveyed said they have used or would consider using cannabis to manage pain. Nearly three-quarters of millennials fall in that category. Two-thirds of Gen Xers and baby boomers expressed interest in cannabis, with 25% of Gen Xers and 18% of baby boomers saying they have used cannabis for pain.

Most of those who expressed interest in using cannabis products believe they are safer or have fewer side effects than opioids or other medications.

Other key findings:

  • 57% believe more cannabis research is needed

  • 34% don't feel a need to discuss cannabis use with their doctor

  • 13% believe no other type of pain management works for them

  • 40% wrongly believe CBD products sold at grocery stores, truck stops, health food stores and dispensaries are approved by the FDA.

The ASA recently endorsed two bills that seek to expand research on CBD and marijuana: the Medical Cannabis Research Act and the Cannabidiol and Marihuana Research Expansion Act. The bipartisan bills would increase the number of manufacturers allowed to grow cannabis for research purposes and streamline the application process.

“As experts in managing pain, physician anesthesiologists are concerned about the lack of research regarding the safety and effectiveness of marijuana and cannabinoids," said ASA President Linda Mason, MD.

Government Grown Cannabis May Be Harming Research

By Roger Chriss, PNN Columnist

Physician researcher Sue Sisley, MD, has filed suit against the federal government over the quality of cannabis provided for her study on post-traumatic stress disorder. Sisley claims that the cannabis supplied by the DEA-sanctioned facility at the University of Mississippi is “suboptimal.”

Sisley told Green Entrepreneur that the DEA provided "standardized green powder that is just cannabis ground up.” She also said that the plants were moldy and contained sticks and seeds. 

Sisley is not the first researcher to say government cannabis intended for research is not the same as the cannabis available in dispensaries. This of course poses a key question: What is research cannabis?

Cannabis is a plant. Specifically, cannabis is the genus of a plant that includes the species C. sativa, C. indica, and C. ruderalis. There is still dispute if C. ruderalis should be included with C. sativa, or if all three species should be considered a single species, C. sativa. 

There is no precise pharmacological definition of medical cannabis. There is no agreed-upon level of THC, CBD, or other cannabinoids, and no accepted terpene profile. In dispensaries, cannabis comes in a large variety of strains used in a wide range of products. 

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There is poor consistency among strains. Leafly recently attempted to measure the reliability of cannabis strains and found that even the most reliable ones were far from consistent at the levels necessary for clinical research.

Moreover, cannabis is a moving target. Because it is a commercial product often intended for nonmedical use, it is subject to a variety of market forces involving its various psychogenic effects. And new strains are introduced regularly. 

Further, cannabis products are consumed in many different ways, such as smoking, vaporizing, ingesting and through the skin . The bioavailability of cannabis varies significantly by route of consumption because of different absorption levels and metabolism. So whatever research cannabis is used would have to be specified by strain, amount and route of administration. 

For research purposes, that requires precise information. But as Genetic Engineering & Biotechnology News reported, medical cannabis comes in so many forms and has so many different uses that it presents a "unique challenge to cannabis testing laboratories." No existing test provides a good model on how to proceed.

In other words, there is no clear definition of research cannabis and there is no practical way to reliably test commercial strains with a consistency adequate for clinical studies. 

This means the definition of research cannabis is arbitrary. Researchers and advocates keep adjusting the definition or questioning the quality to explain away poor outcomes. According to Microscopes and Machines, when Dr. Sisley's PTSD study concluded, she unblinded the data and quickly came to realize the quality of cannabis provided by the University of Mississippi "had negatively affected the study’s efficacy data.”

But we cannot define research cannabis as the form of cannabis that only gives the results we were hoping for. This would be circular and self-justifying. It would also be self-defeating since we’d never know what, if anything, cannabis has to offer. 

Cannabis is a plant, not a laboratory-synthesized chemical being turned into a USP-grade pharmaceutical. As Jonathan Stea wrote in Scientific American,“it is best to conceptualize cannabis as a chemical soup with over 500 ingredients that can be served in countless different ways.”

This means that researchers will need to define their cannabis before starting a study. And the U.S. government will need to provide such cannabis. Fortunately, the National Institutes of Health is responding by producing more varieties of cannabis.

A more favorable legal landscape would also help. There may not be any “research cannabis” per se, but cannabis is certainly worth researching. 

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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.

Medical Cannabis Won’t Solve the Opioid Crisis

By Roger Chriss, PNN Columnist

Medical cannabis legalization isn’t helping reduce opioid overdoses. Two major studies have closely examined over a decade’s worth of data, finding no support for the idea that legalizing medical cannabis reduces prescription opioid use, overdose or mortality.

In June, Stanford researchers led by Chelsea Shover, PhD, published a study in PNAS using the same methodology as a 2014 JAMA study that found a positive association between cannabis legalization and lower opioid mortality from 1999 to 2010. But Shover and colleagues included more recent data and states with legalized medical cannabis.

“Our expanded analysis does not support the interpretation that broader access to cannabis is associated with lower opioid overdose mortality,” they concluded.

The 2014 study was very cautious in its findings, but cannabis advocates and industry representatives used it to support legalization efforts.

“It’s become such a pervasive idea,” Shover told STAT News. “It would be amazing if it was this simple, but the evidence is telling us now that it’s not.”

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Early this month, Columbia University’s Mailman School of Public Health published a new study in JAMA Network Open that looked at whether people use cannabis in place of prescription opioids.  Researchers looked at data from 627,000 people aged 12 years and older who took the National Survey on Drug Use and Health from 2004 to 2014.

The results showed that enactment of medical marijuana laws was not associated with a reduction in prescription opioid abuse, contradicting the hypothesis that people would substitute marijuana for prescription opioids.

“We tested this relationship and found no evidence that the passage of medical marijuana laws — even in states with dispensaries — was associated with a decrease in individual opioid use of prescription opioids for nonmedical purposes," said senior author Silvia Martins, MD, PhD, an associate professor of epidemiology at Columbia.

The Shover-PNAS study also made the important point that medical cannabis users comprise only about 2.5% of the U.S. population. The vast majority of cannabis use is recreational. The Washington State Liquor Control and Cannabis Board estimates that only about 20% of so-called medical users are really using cannabis for medical reasons.

In other words, there aren’t enough medical cannabis users to impact nationwide overdose trends. And in state-level analysis, there is no evidence of any substantial effect, positive or negative, from medical cannabis legalization.

There are concerns that cannabis could actually make the opioid crisis worse. A 2018 study published in the American Journal of Psychiatry found that “cannabis use appears to increase rather than decrease the risk of developing nonmedical prescription opioid use and opioid use disorder.”

Scientific evidence does not support claims that marijuana helps people kick opioids.
— Dr. Nora Volkow, NIDA Director

"My main concern is by basically misinforming potential patients about the supposedly beneficial effects of cannabis, they may forgo a treatment that is lifesaving," NIDA director Nora Volkow, MD, told USA Today. “Scientific evidence does not support claims that marijuana helps people kick opioids.”

The FDA is taking note, warning a large cannabis operator last week to stop making unsubstantiated claims that its products can treat chronic pain, cancer, opioid withdrawal and other medical conditions.

Medical cannabis has uses, of course, but taking it for conditions it is not proven to help may lead to harms. Perhaps a way can be found to incorporate cannabis in addiction treatment, but that is quite different from expecting medical cannabis legalization to be an exit ramp for the opioid crisis.

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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.

FDA Warns Curaleaf About Marketing of CBD Products

By Pat Anson, PNN Editor

The U.S. Food and Drug Administration is warning a large cannabis company to stop making unsubstantiated claims that its products can treat chronic pain, cancer, opioid withdrawal and other medical conditions.

An FDA warning letter was sent to Curaleaf, a Massachusetts-based company that sells cannabidiol (CBD) products online and in stores, and operates dispensaries in a dozen states. CVS Health responded to the FDA letter by pulling some Curaleaf products off its store shelves.

“Selling unapproved products with unsubstantiated therapeutic claims — such as claims that CBD products can treat serious diseases and conditions — can put patients and consumers at risk by leading them to put off important medical care. Additionally, there are many unanswered questions about the science, safety, effectiveness and quality of unapproved products containing CBD,” acting FDA Commissioner Ned Sharpless, MD, said in a statement. “Consumers should beware of purchasing or using any such products.”

Curaleaf, which claims to be the largest cannabis operator in the United States, makes an extensive line of CBD lotions, creams, oils and skin patches.

It recently began marketing a line of CBD products for pets to treat pain, spasms, anxiety and inflammation in animals.

The FDA’s warning letter to Curaleaf cited a number of unapproved marketing claims made by the company online and in social media, including:

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  • “CBD was effective in killing human breast cancer cells.”

  • “CBD has been linked to the effective treatment of Alzheimer’s disease…”

  • “CBD is being adopted more and more as a natural alternative to pharmaceutical-grade treatments for depression and anxiety.”

  • “CBD can also be used in conjunction with opioid medications, and a number of studies have demonstrated that CBD can in fact reduce the severity of opioid-related withdrawal and lessen the buildup of tolerance.”

  • “CBD oil is becoming a popular, all-natural source of relief used to address the symptoms of many common conditions, such as chronic pain, anxiety … ADHD.”

The FDA gave Curaleaf 15 working days to respond. Failure to correct the violations could result in legal action, including seizure of the company’s products.

“Curaleaf is committed to the highest standards of quality and compliance, and will work collaboratively with the FDA to resolve all issues addressed in the agency's letter,” the company said in a statement.

“Compliance is a top priority for Curaleaf and the Company is fully committed to complying with FDA requirements for all of the products that it markets. We can affirm that nothing in the letter raises any issues concerning the quality and consistency of any Curaleaf product or calls into question the high safety standards of the Company's cultivation and manufacturing processes.”

CBD Products Loosely Regulated

Unlike prescription drugs approved by the FDA, the manufacturing process for CBD products is not subject to FDA review, and there has been no FDA evaluation of their effectiveness, proper dosage, how they could interact with drugs, or whether they have side effects.

Despite the lack of regulatory oversight, there has been explosive growth for CBD companies and their products are starting to appear in mainstream stores. In March, CVS Pharmacy and Walgreens started selling CBD lotions, tinctures, edibles and lozenges — including some made by Curaleaf.

“The only Curaleaf products we are selling are its CBD lotion and CBD transdermal patches,” CVS said in a statement. “Following the FDA’s warning letter to Curaleaf, we will be removing these items from our CBD offering.”  

The FDA sent similar warning letters to three cannabis operators in April. Until now, the enforcement actions have been sporadic and only targeted small companies.

“We will continue to work to protect the health and safety of American consumers from products that are being marketed in violation of the law through actions like those the FDA is taking today. At the same time, we also recognize the potential opportunities and significant interest in drug and other consumer products containing CBD,” said FDA Principal Deputy Commissioner Amy Abernethy, MD.

“We understand this is an important national issue with public health impact and of interest to American hemp farmers and many other stakeholders. The agency has a well-established pathway for drug development and drug approvals, and we remain committed to evaluating the agency’s regulatory policies related to other types of CBD products.”

The FDA held a public hearing on the issue in May, and opened a docket for public comments to obtain scientific data about the safety, manufacturing, quality, marketing, labeling and sale of CBD products. Nearly 4,500 comments were received. The agency plans to report on its progress this fall.

This week Curaleaf announced it will acquire GR Companies, a large cannabis retailer, in a cash and stock deal valued at $875 million. Curaleaf said the purchase solidifies it’s position as “the world's largest cannabis company by revenue and the largest in the U.S. across key operating metrics.”