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.”

Study Finds Cannabis Increases Pain Tolerance

By Steve Weakley

Medical marijuana is often touted as a promising new form of pain relief.  But a new study found that cannabinoids may not reduce pain as much as they increase our tolerance of pain and make it less unpleasant.

Researchers at Syracuse University conducted a systematic review of 18 placebo-controlled studies involving nearly 450 participants who used a wide variety of cannabis products, including plant-based marijuana and two synthetic marijuana-based drugs, dronabinol and nabilone.

Because most previous cannabis studies have only examined patients with chronic pain, which is often associated with depression, anxiety and other symptoms that could bias results, the researchers only selected studies that used healthy individuals and laboratory tests that induced “experimental” pain.  

They reported in the journal JAMA Psychiatry that cannabinoids did not reduce pain intensity, but made the experimental pain “feel less unpleasant and more tolerable.”

"If you think of pain as a noxious sound coming from a radio, the volume is the intensity of that pain," researcher Martin De Vita told MedPage Today. "After using cannabinoid drugs, it may not decrease the volume of the noxious noise, but it may tune it to a station that's a little less unpleasant. It won't be the most beautiful music you've ever heard -- it will still be pain -- but it will be a little less unpleasant.”

Researchers found that relatively high cannabinoid dosages improved pain tolerance, but low doses had little or no effect.  The plant-based marijuana was also more effective at reducing pain than the synthetic pharmaceuticals drugs, which are primarily used to prevent nausea.

De Vita says findings from the 18 placebo-controlled studies are somewhat compromised because patients getting the plant-based cannabis “felt high,” while those getting placebo did not. He said future studies need to test non-psychoactive cannabinoids like cannabidiol, which do not have tetrahydrocannabinol (THC), the substance in marijuana that causes euphoria.

"Everyone is saying we need more research and that we need to catch up," De Vita said. "This is a first step in doing that, starting from the fundamentals of how cannabinoids affect basic pain processes, and now we need to determine some of these follow-up questions." 

This is not the first study to get mixed results on the effectiveness of cannabis in treating pain. A recent Australian study of over 1,500 adults with chronic pain, published in The Lancet Public Health, found "no evidence that cannabis use improved patient outcomes.”

But a 2017 report by the National Academies of Sciences (NAS) found “substantial evidence” that cannabis is an effective treatment for chronic pain. The NAS found that “cannabinoids demonstrate a modest effect on pain.” 

Seniors in Pain Hop Aboard the Canna-Bus

By Stephanie O’Neill, Kaiser Health News

Shirley Avedon, 90,­­ had never been a cannabis user. But carpal tunnel syndrome that sends shooting pains into both of her hands and an aversion to conventional steroid and surgical treatments is prompting her to consider some new options.

“It’s very painful, sometimes I can’t even open my hand,” Avedon said.

So for the second time in two months, she’s climbed on board a bus that provides seniors at the Laguna Woods Village retirement community in Orange County, Calif., with a free shuttle to a nearby marijuana dispensary.

The retired manager of an oncology office says she’s seeking the same relief she saw cancer patients get from smoking marijuana 25 years ago.

“At that time [marijuana] wasn’t legal, so they used to get it off their children,” she said with a laugh. “It was fantastic what it did for them.”

Avedon, who doesn’t want to get high from anything she uses, picked up a topical cream on her first trip that was sold as a pain reliever. It contained cannabidiol, or CBD, but was formulated without THC, or tetrahydrocannabinol, marijuana’s psychoactive ingredient.

“It helped a little,” she said. “Now I’m going back for the second time hoping they have something better.”

As more states legalize marijuana for medical or recreational use — 30 states plus the District of Columbia to date — the cannabis industry is booming. Among the fastest growing group of users: people over 50, with especially steep increases among those 65 and older. And some dispensaries are tailoring their pitches to seniors like Avedon who are seeking alternative treatments for their aches, pains and other medical conditions.

On this particular morning, about 35 seniors climb on board the free shuttle — paid for by Bud and Bloom, a licensed cannabis dispensary in Santa Ana.

After about a half-hour drive, the large white bus pulls up to the parking lot of the dispensary.

About half of the seniors on board today are repeat customers; the other half are cannabis newbies who’ve never tried it before, said Kandice Hawes, director of community outreach for Bud and Bloom.

“Not everybody is coming to be a customer,” Hawes said. “A lot are just coming to be educated.”

STEPHANIE O’NEILL FOR KHN

Among them, Layla Sabet, 72, a first-timer seeking relief from back pain that keeps her awake at night, she said.

“I’m taking so much medication to sleep and still I can’t sleep,” she said. “So I’m trying it for the back pain and the sleep.”

Hawes invited the seniors into a large room with chairs and a table set up with free sandwiches and drinks. As they ate, she gave a presentation focused on the potential benefits of cannabis as a reliever of anxiety, insomnia and chronic pain and the various ways people can consume it.

Several vendors on site took turns speaking to the group about the goods they sell. Then, the seniors entered the dispensary for the chance to buy everything from old-school rolled joints and high-tech vaporizer pens to liquid sublingual tinctures, topical creams and an assortment of sweet, cannabis-infused edibles.

Jim Lebowitz, 75, is a return customer who suffers pain from back surgery two years ago.

He prefers to eat his cannabis, he said.

“I got chocolate and I got gummies,” he told a visitor. “Never had the chocolate before, but I’ve had the gummies and they worked pretty good.”

“Gummies” are cannabis-infused chewy candies. His contain both the CBD and THC, two active ingredients in marijuana.

Derek Tauchman rings up sales at one of several Bud and Bloom registers in the dispensary. Fear of getting high is the biggest concern expressed by senior consumers, who make up the bulk of the dispensary’s new business, he said.

“What they don’t realize is there’s so many different ways to medicate now that you don’t have to actually get high to relieve all your aches and pains,” he said.

Limited Research

But despite such enthusiasm, marijuana isn’t well researched, said Dr. David Reuben, the Archstone Foundation professor of medicine and geriatrics at UCLA’s David Geffen School of Medicine.

While cannabis is legal both medically and recreationally in California, it remains a Schedule 1 substance — meaning it’s illegal under federal law. And that makes it harder to study.

The limited research that exists suggests that marijuana may be helpful in treating pain and nausea, according to a research overview published last year by the National Academies of Sciences, Engineering and Medicine. Less conclusive research points to it helping with sleep problems and anxiety.

STEPHANIE O’NEILL FOR KHN

Reuben said he sees a growing number of patients interested in using it for things like anxiety, chronic pain and depression.

“I am, in general, fairly supportive of this because these are conditions [for which] there aren’t good alternatives,” he said.

But Reuben cautions his patients that products bought at marijuana dispensaries aren’t FDA-regulated, as are prescription drugs. That means dose and consistency can vary.

“There’s still so much left to learn about how to package, how to ensure quality and standards,” he said. “So the question is how to make sure the people are getting high-quality product and then testing its effectiveness.”

And there are risks associated with cannabis use too, said Dr. Elinore McCance-Katz, who directs the Substance Abuse and Mental Health Services Administration.

“When you have an industry that does nothing but blanket our society with messages about the medicinal value of marijuana, people get the idea this is a safe substance to use. And that’s not true,” she said.

Side effects can include increased heart rate, nausea and vomiting, and with long-term use, there’s a potential for addiction, some studies say. Research suggests that between 9 and 30 percent of those who use marijuana may develop some degree of marijuana use disorder.

Still, Reuben said, if it gets patients off more addictive and potentially dangerous prescription drugs — like opioids — all the better.

Jim Levy, 71, suffers a pinched nerve that shoots pain down both his legs. He uses a topical cream and ingests cannabis gelatin capsules and lozenges.

“I have no way to measure, but I’d say it gets rid of 90 percent of the pain,” said Levy, who — like other seniors here — pays for these products out-of-pocket, as Medicare doesn’t cover cannabis.

“I got something they say is wonderful and I hope it works,” said Shirley Avedon. “It’s a cream.”

The price tag: $90. Avedon said if it helps ease the carpal tunnel pain she suffers, it’ll be worth it.

“It’s better than having surgery,” she said.

Precautions to Keep in Mind

Though marijuana use remains illegal under federal law, it’s legal in some form in 30 states and the District of Columbia. And a growing number of Americans are considering trying it for health reasons. For people who are, doctors advise the following cautions.

Talk to your doctor. Tell your doctor you’re thinking about trying medical marijuana. Although he or she may have some concerns, most doctors won’t judge you for seeking out alternative treatments.

Make sure your prescriber is aware of all the medications you take. Marijuana might have dangerous interactions with prescription medications, particularly medicines that can be sedating, said Dr. Benjamin Han, a geriatrician at New York University School of Medicine who studies marijuana use in the elderly.

Watch out for dosing. Older adults metabolize drugs differently than young people. If your doctor gives you the go-ahead, try the lowest possible dose first to avoid feeling intoxicated. And be especially careful with edibles. They can have very concentrated doses that don’t take effect right away.

Elderly people are also more sensitive to side effects. If you start to feel unwell, talk to your doctor right away. “When you’re older, you’re more vulnerable to the side effects of everything,” Han said. “I’m cautious about everything.”

Look for licensed providers. In some states like California, licensed dispensaries must test for contaminants. Be especially careful with marijuana bought illegally. “If you’re just buying marijuana down the street … you don’t really know what’s in that,” said Dr. Joshua Briscoe, a palliative care doctor at Duke University School of Medicine who has studied the use of marijuana for pain and nausea in older patients. “Buyer, beware.”

Bottom line: The research on medical marijuana is limited. There’s even less we know about marijuana use in older people. Proceed with caution.

Kaiser Health News (KHN) is a national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation which is not affiliated with Kaiser Permanente.

App Helps Document Effectiveness of Medical Cannabis

By Pat Anson, PNN Editor

Two innovative studies have found evidence that medical marijuana can provide significant relief from a wide range of symptoms associated with chronic pain, including insomnia, seizures, depression, anxiety and fatigue.

Unlike many clinical trials that evaluate a small number of patients with surveys, researchers at the University of New Mexico relied on data from the Releaf App, a free mobile software program that collected user-entered, real-time information from over 2,800 people on their use of cannabis and its effects.

"If the results found in our studies can be extrapolated to the general population, cannabis could systematically replace multi-billion dollar medication industries around the world. It is likely already beginning to do so," said co-author Jacob Vigil, PhD, a UNM psychology professor.

In the first study, published in the journal Frontiers in Pharmacology, users reported an average symptom reduction of nearly 4 points on a 1-10 scale after the consumption of cannabis in various forms, including vaporizers, joints, oils and topicals.

Twenty-seven different health conditions were evaluated, from inflammation and tremors to muscle and nerve pain. Over 94 percent of cannabis users reported some type of symptom relief, with patients suffering from anxiety and depression having the greatest improvement.

“Clinically and statistically significant reductions in patient-reported symptom severity levels existed in every single symptom category, suggesting that cannabis may be an effective substitute for several classes of medications with potentially dangerous and uncomfortable side effects and risky polypharmaceutical interactions, including opioids, benzodiazepines, and antidepressants,” said Vigil.

“Our results indicate that patients report greater symptom relief for treating agitation/irritability, anxiety, depression, excessive appetite, insomnia, loss of appetite, nausea, gastrointestinal pain, stress, and tremors than they do for treating back pain. Patients reported less symptom relief for treating impulsivity, headache, and nerve pain as compared to relief for treating back pain.

source: frontiers in pharmacology

The second study, recently published in the journal Medicines, focused on the use of cannabis flower (also known as “buds”) in treating insomnia. Over 400 patients self-reported their symptoms using the Releaf app. Researchers found the use of pipes and vaporizers to ingest cannabis was associated with greater symptom relief and fewer negative side effects than the use of joints. Cannabidiol (CBD) was also associated with greater symptom relief than tetrahydrocannabinol (THC), the active ingredient in marijuana that causes euphoria.

A major weakness of both studies is that there was no control group or use of a placebo. Participants were also more likely to have previously used cannabis and may have been biased when reporting on their own symptoms. But UNM researchers say their findings are more representative of what cannabis users will actually experience.

“Observational studies are more appropriate than experimental research designs for measuring how patients choose to consume cannabis and the effects of those choices,” said Vigil. “By collecting massive amounts of patient-entered information on actual cannabis used under real-life circumstances we are able to measure why patients consume cannabis, the types of products that patients use, and the immediate and longer-term effects of such use.”

In addition to its therapeutic benefits, cannabis use was associated with frequent, although not serious side effects. Patients reported more positive feelings (relaxed, peaceful, comfy) than they did negative ones (paranoid, confused, headache).  

"If the short-term risk-benefit profile of cannabis found in our studies reflects its longer-term therapeutic potential, substitution of cannabis for traditional pharmaceuticals could reduce the risk of dangerous drug interactions and the costs associated with taking multiple medications by allowing patients to treat a constellation of comorbidities with a single treatment modality,” said co-author Sarah See Stith, PhD, a UNM economics professor.

Marijuana Use by Baby Boomers Growing

By Pat Anson, Editor

Marijuana use by middle-aged and older adults in the U.S. has grown significantly over the past decade, in part because more baby boomers are seeking relief from neuropathy and other painful conditions associated with aging.

In a survey of over 17,600 adults aged 50 and older, researchers found that 9 percent of adults aged 50-64 reported marijuana use in the past year, double the percentage that used it a decade earlier. Nearly 3 percent of adults 65 and older also reported marijuana use, seven times the number that used it a decade ago.

DRUG POLICY ALLIANCE

The 2015-2016 National Survey on Drug Use and Health asked respondents about their marijuana use, including when they first used it and whether they used it in the past year. The researchers also looked at several health issues, including substance use and chronic disease.

"Marijuana has been shown to have benefits in treating certain conditions that affect older adults, including neuropathic pain and nausea,” said lead author Benjamin Han, MD, MPH, a professor of Geriatric Medicine and Palliative Care at NYU School of Medicine.

“However, certain older adults may be at heightened risk for adverse effects associated with marijuana use, particularly if they have certain underlying chronic diseases or are also engaged in unhealthy substance use.”

Han and his colleagues say adults who used marijuana were more likely to also report alcohol use disorder, nicotine dependence, cocaine use, and misuse of prescription medications (including opioids and sedatives) than non-users.

The new findings, published online in the journal Drug and Alcohol Dependence, builds on an earlier study by the same researchers that found a significant increase in cannabis use among adults over 50.

Twenty-nine states and the District of Columbia have legalized medical marijuana and a handful of states allow its recreational use. Although today's marijuana users are more likely to be young adults, the baby boomer generation is unique, having more experience with recreational use of drugs than previous generations. Many baby boomers first tried marijuana when they were 21 or younger.

“The baby boomer generation grew up during a period of significant cultural change, including a surge in popularity of marijuana in the 1960s and 1970s. We're now in a new era of changing attitudes around marijuana, and as stigma declines and access improves, it appears that baby boomers -- many of whom have prior experience smoking marijuana -- are increasingly using it," said Han.

Many older adults who used marijuana in the past year (15% of users aged 50-64 and nearly 23% of those 65 and older) reported that a doctor had recommended it to them.

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 and should be available to patients with a doctor’s recommendation.

Study Finds Racial Bias in Drug Testing

By Pat Anson, Editor

African-American patients on long-term opioid therapy are more likely to be drug tested by their doctors and significantly more likely to have their opioid prescriptions stopped if an illicit drug is detected, according to a new study.

Yale researchers analyzed the health records of more than 15,000 patients who received opioids from the Veterans Administration between 2000 and 2010. About half of the VA patients were white and half black.

Over 25 percent of the black patients had a urine drug test within the first six months of opioid treatment, compared to nearly 16% of whites.

When patients tested positive for either marijuana or cocaine, the vast majority – 90 percent -- continued to receive their opioid prescriptions. But there were significant differences in how patients were treated depending on their race.

Black patients that tested positive for marijuana were twice as likely as whites to have opioid therapy stopped and three times more likely to have opioids discontinued if cocaine was detected in their urine.

The findings, published in the journal Drug and Alcohol Dependence, are consistent with previous research showing disparities in how blacks and whites are treated by the healthcare system in general, and particularly when opioids are involved.

“There is no mandate to immediately stop a patient from taking prescription opioids if they test positive for illicit drugs,” said first author Julie Gaither, PhD, a pediatrics instructor at the Yale School of Medicine.

“It’s our feeling that without clear guidance, physicians are falling back on ingrained stereotypes, including racial stereotyping. When faced with evidence of illicit drug use, clinicians are more likely to discontinue opioids when a patient is black, even though research has shown that whites are the group at highest risk for overdose and death.”

A 2016 study of emergency room patients found that blacks were significantly less likely to get an opioid for abdominal pain than whites. Another study of white medical students and residents found that half had at least one false belief about black patients. Those that did were more likely to report lower pain ratings for black patients.

Drug Testing for Marijuana Not Recommended

The 2016 CDC opioid guideline encourages doctors to conduct urine drug tests before starting opioid therapy and at least annually after patients start taking the drugs. But the guideline also urges physicians not to test opioid patients for tetrahyrdocannabinol (THC), the psychoactive ingredient in marijuana that makes people high.

“Clinicians should not test for substances for which results would not affect patient management or for which implications for patient management are unclear. For example, experts noted that there might be uncertainty about the clinical implications of a positive urine drug test for tetrahyrdocannabinol (THC).” the guideline states.

"Clinicians should not dismiss patients from care based on a urine drug test result because this could constitute patient abandonment and could have adverse consequences for patient safety, potentially including the patient obtaining opioids from alternative sources and the clinician missing opportunities to facilitate treatment for substance use disorder."

Another factor to consider is the unreliability of urine drug tests. As PNN has reported, “point-of care” (POC) urine drug tests, the kind widely used in doctor’s offices, frequently giving false positive or false negative results for marijuana, cocaine and other drugs. 

A 2015 study found that 21% of POC tests for marijuana and 12% of those for cocaine produced a false positive result.

A Reality Check for CBD Oil

By Roger Chriss, PNN Columnist

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

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

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

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

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

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

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

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

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

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

CBD Safety Questions

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

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

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

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

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

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

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

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 Saved My Life

By Tammy Malone, Guest Columnist

People are talking about the addicts who are overdosing due to the opioid epidemic. Maybe we should start talking about the people who take opioids just to be able to function in life. 

Chronic intractable pain is a terrible way to live.  I know from experience that when you live in that much pain, you get to a point where all you can see is the ultimate way out.  Chronic pain is blinding.  It blinds you from life, family, joy and happiness.  It robs you of your hopes and dreams, until you are left withering, suffering and asking yourself, "Is this all my life is ever going to consist of? Living in so much pain?"

Too many of us are forced to live this way. For some, it is just too much to bear and suicide is our only way out.  

I can honestly say I have thought of this.  I was in so much pain I was contemplating suicide. Then I found a compassionate, caring group of doctors at a Tennessee pain clinic and my life was spared.  I was given shots, acupuncture, and massage.  I started an anti-inflammatory diet that helps slow down the destruction of Lyme disease, which is breaking down the joints and bones in my body. 

I was also put on a manageable dose of the opioid medication Demerol.  For 6 years, I had my  dreams back. I could see a future filled with family, friends,  joy and happiness. 

My body is still breaking down and nothing is going to change that.  I'm 53 and have the spine of a 90 year old.  I've shrunk over half an inch due to the discs deteriorating in my back. I've had 3 discs removed and my spine fused. Both knees are bone on bone.  My hip joints have deteriorated and my shoulders are blown out. I have fluid pockets in many of the joints, so it's not only painful but difficult to move. 

This destruction is not going to stop or get better, and I don't care how many Tylenol you throw at it,  it won't touch the pain.  But the pain management clinic helped me exist.  The opioids helped me function  and have a life beyond the blinding pain.  It gave me another 2,372 days with my family and friends. 

TAMMY MALONE

Then came the War on Opioids. My doctor discussed the issues this war was having on his practice and what it meant for his patients. What it was going to ultimately mean for me.  To say I was in a panic is an understatement.  The thought of returning to a life in that much pain was unfathomable. 

I knew I had about 6 months before the do-gooders and Big Brother were going to push my doctor to start tapering me down. We discussed the other options, which we had or were already doing, and I cried.  I knew what was coming.  An unacceptable existence. 

This was the same time my parents had talked about getting me and my husband a plane ticket to Montana for a mini-vacation at our family cabin in the Rockies.  I really thought it was going to be my last family vacation. Because in a year,  I wouldn't be around. Suicide was already in my forethought. 

Although the stress of it all had begun to increase my pain levels, I agreed to go.  The night I stepped off the plane, my ankles swelled to the size of my calves and I couldn't walk. In 11 days at the family cabin, I lost 22 pounds due to inflammation,  elevation and the dryness of the mountain air. But I enjoyed the vacation and was happy I went. 

I also learned that Montana was a medical marijuana state.

Over the next couple of weeks back home in Tennessee, I asked my entire team of doctors, seven in all, what they thought about medical cannabis. With the exception of my neurologist, they all agreed it might be an option.  So we sold our dream property, got rid of our horses, sold everything in Tennessee and moved to Montana.  

Starting Medical Cannabis

I'd like to say everything is 100% better, but that wouldn't be accurate.  Moving to Montana and starting medical cannabis has been a challenge.  After an incredibly stressful time of trying to find doctors who would even look at my medical records, I was able to find a compassionate doctor in Helena named Dr. Mark Ibsen.  He went over my medical history, looked at my extensive list of medications, and reviewed my medical folders, MRI's and x-rays. After an hour of discussion, he agreed to take me on.  I cried with relief.  He was my lifeline.

It took 6 months to taper me off my pain meds and reduce the other 44 pills I took everyday down to 7.  Trying to find the right strain of medical cannabis hasn't been easy. I don't like to feel high or drugged (Demerol never made me feel that way), and finding the proper dosage of cannabis has been a challenge. 

Cannabis doesn't relieve the pain completely. While Demerol kept the pain manageable at a 3-4 level, cannabis keeps me at a level 6, which is uncomfortable most days.  Occasionally,  when I overdo things,  I can spend 24 to 36 hours at a level 8.5. Those are the days I wish I was still taking the opioids or at least had them as an option.

All in all, I was lucky.  I was lucky my parents thought to give me a vacation that unexpectedly showed me there was another medical option. I was lucky my husband agreed that we should sell everything and try Montana.  I was also lucky to find a compassionate doctor. It saved my life. 

But I also think about all the other pain patients who do not have options.  The "War on Opioids" has become a "War on Pain Patients."  I did some research and found the opioid overdose numbers being publicized include all overdoses from heroin.  These are addicts who are dying, not pain patients.

Not too long ago, I had a supposed friend call me an addict because she had preconceived idea of how I was living my life.  That taking pain meds to function made me the same as her opioid-addicted son, someone who did whatever it took to get his fix.  She hurt me and it cost a friendship, but it also made me see that too many of us are getting labeled.

Things need to change.  We need to be heard and we need to tell our stories.  We don't need to have people in Washington, DC leave us with suicide as the only option of living a pain free life. Too many of us are dying as it is.  Please leave our pain management doctors alone as they are our lifeline to the future. 

Tammy Malone lives with complex late-stage Lyme disease and Bartonella, a bacterial infection of the blood vessels. Both are spread by ticks. Tammy was first bitten by a tick in 2008.

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.

Australian Study Finds Cannabis Does Little for Pain

By Roger Chriss, PNN Columnist

A controversial study recently published in The Lancet Public Health followed over 1,500 Australian adults with chronic non-cancer pain for four years – one of the longest studies of its kind. All used prescription opioids and about half tried using cannabis for pain, some occasionally and others daily or near daily.

Advocates of medical marijuana as a treatment for pain may be surprised by the findings.

In the Pain and Opioids IN Treatment (POINT) study, Gabrielle Campbell, PhD, and colleagues at the University of New South Wales found "no evidence that cannabis use improved patient outcomes.”

"At each assessment, participants who were using cannabis reported greater pain and anxiety, were coping less well with their pain, and reported that pain was interfering more in their life, compared to those not using cannabis," said Campbell, who was lead author of the study. "There was no clear evidence that cannabis led to reduced pain severity or pain interference or led participants to reduce their opioid use or dose."

These findings are not unique. Campbell was co-author of a recent review in the journal Pain that found that “evidence for effectiveness of cannabinoids in chronic non-cancer pain is limited.”  Cochrane reviews came to similar conclusions about cannabis for treating fibromyalgia and neuropathic pain.

In short, cannabis helps, but maybe not that much.

The POINT study would seem to contradict the 2017 National Academies of Sciences (NAS) report, which found “substantial evidence” that cannabis is an effective treatment for chronic pain, but in only five good-to-fair quality studies. Overall, the NAS report found that “cannabinoids demonstrate a modest effect on pain.”

About a third of the cannabis users in the POINT study reported reduced opioid use, but the prescription data showed that there was actually no difference.

The study also found that most cannabis users believed they were benefiting from cannabis, but there was no objective improvement in their pain scores.

“It is really difficult to disentangle the reasons for this,” Campbell told Cosmos. “One hypothesis is that it may improve sleep and subjective well-being.”

This is consistent with other findings that cannabis doesn’t reduce pain, but helps people feel better. The book “A New Leaf: The End of Cannabis Prohibition” states that “patients often say that cannabis mostly disassociates them from the pain, like it’s placed in another room instead of eliminated.”

Similar results were obtained in an Oxford study, which found that “an oral tablet of THC, the psychoactive ingredient in cannabis, tended to make the experience of pain more bearable, rather than actually reduce the intensity of the pain.”

Masking pain may seem like a good thing. But as Grant Brenner, MD, points out in Psychology Today, believing that there is a benefit when there isn't one is problematic. Making pain more bearable may improve mood and sleep, but it could also lead patients to underestimate the significance of a serious health issue. This problem applies to many forms of pain management and requires further research.

“The illusion that a drug is helping with a condition when it is not can get in the way of seeking effective treatment and obtaining real relief,” said Brenner. “Rather than helping with actual pain, difficulty from pain, and need for opioid medication, cannabis consumption may lead people to believe they are improving when in reality they are not.”

The POINT study found what many other studies have been finding about cannabis and chronic pain: Some people experience some benefits some of the time. But the study also has limitations. Participants had chronic pain severe enough to merit opioid therapy, so they may not be representative of people with chronic conditions in general. They also only had access to illicit cannabis that was not part of structured pain management program.

Still, as an editorial in The Age points out: "The findings do not mean medical cannabis does not merit a place in the treatment of various other ailments."

Cannabis and cannabis-derived pharmaceuticals like Epidiolex are proving useful for managing seizures, reducing chemotherapy side effects, and treating multiple sclerosis. There may yet be other uses to be discovered. For instance, cannabis may be effective for more rare disorders. And cannabis may be a viable add-on therapy or alternative for people who cannot tolerate or do not do well with conventional therapies.

The POINT study shows that cannabis is not a panacea for pain. Instead, cannabis is a drug, and we have to treat it with the respect we give any drug if we're going to learn how to use it 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.

FDA Approves First Marijuana-Based Prescription Drug

By Pat Anson, Editor

The U.S. Food and Drug Administration has approved the use of Epidiolex, the first drug derived directly from marijuana, to treat seizures caused by two rare and severe forms of childhood epilepsy, Lennox-Gastaut syndrome and Dravet syndrome.

Epidiolex is the first FDA-approved medication that contains cannabidiol (CBD), one of the active ingredients in marijuana. It does not contain tetrahydrocannabinol (THC), the chemical compound in marijuana that makes people high.

“This is an important medical advance. But it’s also important to note that this is not an approval of marijuana or all of its components. This is the approval of one specific CBD medication for a specific use. And it was based on well-controlled clinical trials evaluating the use of this compound in the treatment of a specific condition,” FDA commissioner Scott Gottlieb, MD, said in a statement.

FDA approval of Epidiolex is a major milestone for GW Pharmaceuticals, a British company focused on developing CBD-based medications. The company said Epidiolex would be available in the fall, but did not disclose the price. Some analysts have predicted it could cost as much as $25,000 a year.

Many oils and tinctures containing CBD are already sold online and in states were medical marijuana is legal, but the FDA has not approved any of them. The agency has only approved a handful of synthetic cannabinoids such as Marinol (dronabinol) to treat loss of appetite and nausea.

“We’ll continue to support rigorous scientific research on the potential medical uses of marijuana-derived products and work with product developers who are interested in bringing patients safe and effective, high quality products,” Gottlieb said.

“But, at the same time, we are prepared to take action when we see the illegal marketing of CBD-containing products with serious, unproven medical claims. Marketing unapproved products, with uncertain dosages and formulations can keep patients from accessing appropriate, recognized therapies to treat serious and even fatal diseases.”

Some children in clinical trials experienced side effects from Epidiolex such as liver toxicity, anemia and drowsiness, but an FDA staff report said the risks were “mild to moderate” and could be managed with warning labels. The staff report also found there was low risk of the strawberry flavored Epidiolex being abused.

“Today’s approval of Epidiolex is a historic milestone, offering patients and their families the first and only FDA-approved CBD medicine to treat two severe, childhood-onset epilepsies,” Justin Gover, GW Pharmaceutical’s CEO, said in a statement.

“This approval is the culmination of GW’s many years of partnership with patients, their families, and physicians in the epilepsy community to develop a much needed, novel medicine. These patients deserve and will soon have access to a cannabinoid medicine that has been thoroughly studied in clinical trials, manufactured to assure quality and consistency, and available by prescription under a physician’s care.”

While Epidiolex is only approved for the treatment of Lennox-Gastaut syndrome and Dravet syndrome, doctors will presumably be able to prescribe it “off label” for other conditions such as chronic pain.  

GW Pharmaceuticals also makes Sativex, an oral spray that contains both CBD and THC. Sativex has been approved in Europe, Canada, Australia, New Zealand and several other countries for the treatment of muscle spasticity caused by multiple sclerosis. In Israel, Sativex is also approved for the treatment of pain and chronic non-cancer pain.