Study Finds CBD Ineffective for Chronic Pain

By Pat Anson, PNN Editor

There is little evidence that cannabidiol (CBD) products relieve chronic pain and some could be potentially harmful to patients, according to UK and Canadian researchers.

CBD is one of the chemical compounds found in cannabis, but it doesn’t have the same intoxicating effect as tetrahydrocannabinol (THC), the psychoactive ingredient in marijuana. Often marketed as a pain reliever, CBD can be purchased in edibles, beverages, lotions, oils and other products, usually without a prescription.  

“CBD presents consumers with a big problem,” says lead author Chris Eccleston, PhD, Professor of Pain Science at the University of Bath in the UK. “It’s touted as a cure for all pain but there’s a complete lack of quality evidence that it has any positive effects.

“There should be no excuses for misleading the public, and yet it is likely that the public is being misled and possibly placed in harm’s way.”

Eccleston and his colleagues reviewed the results of 16 high-quality clinical trials of CBD products, involving over 900 participants. Their findings, published in in The Journal of Pain, show that CBD provided little or no pain relief in 15 of the 16 studies. The one small trial that did showed improvement in arthritis pain after two weeks of treatment with a topical CBD lotion.

Just as concerning to researchers is that many CBD products sold directly to consumers have significantly more or less CBD than what their labels indicate. Some CBD products also contain THC, when they weren’t supposed to have any.

“There is no good reason for thinking that CBD relieves pain, but there are good reasons for doubting the contents of CBD products in terms of CBD content and purity,” Eccleston wrote. “Regulatory authorities should also take note of the considerable deficiencies existing in the products sold, especially the incorrect labeling of many products, and possible contamination with psychoactive compounds.”

The researchers say regulators in the US, UK and Canada are often slow to respond to the false medical claims of some CBD manufacturers. The FDA occasionally sends warning letters to companies making unsubstantiated claims about CBD, but it rarely results in fines or disciplinary action.

“What this means is that there are no consumer protections,” said co-author Dr Andrew Moore, Director of Pain Research at the University of Oxford. “And without a countervailing body to keep the CBD sellers in check, it’s unlikely that the false promises being made about the analgesic effects of CBD will slow down in the years ahead.”

In a recent review, the FDA said there was “credible scientific support” for cannabis as a pain reliever and recommended that the DEA reschedule it as a Schedule III controlled substance. Such a move would make it legal under federal law for cannabis to be prescribed for medically approved conditions, but would have no impact on CBD products.

In 2022, FDA Commissioner Dr. Robert Califf asked Congress to give his agency the authority to more closely regulate CBD, but no such legislation has been passed. Eccleston says its part of a pattern in which pain sufferers are neglected and left on their own to find relief.

“It’s almost as if chronic pain patients don’t matter, and that we’re happy for people to trade on hope and despair,” he said.

Medical Marijuana Saved Me After Forced Opioid Tapering

By Christine Kucera

I can tell you outright that medical marijuana saved my life!  

I am an intractable pain patient who was harmed in 2019 when the chief medical officer at my well-known health institution decided to implement mandatory system-wide opioid policies for all doctors and patients, based on the CDC’s opioid guideline.

I am not opioid naive, don't have adverse reactions to opioids (other than some don't work on me), and I wasn't misusing or even at risk of overdose. But that didn't matter to the CMO. He forced my pain management provider to taper all his patients on opioids or risking losing his position.

I was subsequently tapered to 90 MME (morphine milligram equivalent), which was a third of the well-managed opioid regimen I was on for over 30 years.  Messed up, right?  

Medical marijuana/cannabis was the alternative of last resort for me. Unlike opioids, I'm extremely sensitive to marijuana, and need to be able to think and talk. As the taper continued, my ability to cope with unmanageable, agonizing pain went bye-bye. I couldn't sit, stand, lay down or sleep without the pain being unbearable. I was literally being tortured to death.  

I became severely ill, my health destabilized, and I was hospitalized numerous times. I became depressed and suicidal, reaching out to everyone for help as hopelessness set in. Thoughts about transitioning to death were my constant companion. 

I had a choice: fight with what's available or give in to despair. I refused to give up hope and decided to try medical marijuana. After discussing it with my provider, I applied for a Massachusetts medical marijuana license. Once approved, I immediately went to a dispensary and the experimentation began. 

Everyone will have different experiences with cannabis. Just like opioids, it depends how your body metabolizes it. I had more than a few negative experiences, but refused to give up. It took me 2 years of experimentation to figure out the right dose, strain (sativa, indica, hybrid) and preparation (flower, edibles, tinctures, topical).  

After a lot of trial-and-error, I found my goldilocks zone. It was micro dosing a 1:1 tincture (equal parts THC and CBD) and applying a 1:1 cream. That regime saved my life!  

Key to Success: Start Slowly 

Some important things I learned along the way:  

For naive patients using cannabis for the first time, I recommend starting with a couple drops of tincture (0.25ml to 0.5 ml under the tongue) every 6-8 hours. It can take upwards of 2 hours to feel the full effects. Do not consume additional tincture too soon or you will potentially experience a compounding effect, producing unwanted side effects.

Increasing the dose, amount and frequency should only be attempted once your body adjusts. Everyone has different titration periods, which can take days or weeks. Experimenting is the only way to figure out what will work for you personally.

I suggest going slowly, incrementally increasing the dose by 0.25ml (0.5ml, 0.75ml, 1ml and so forth) over days to weeks until you reach optimal effect. I personally use <0.25ml during the day and <0.5ml at night. During my experimentation period with the 1:1 tincture, I would try increasing every 3 days.

There are many types of tinctures. I do not recommend jumping straight to a full strain tincture, using indica or sativa, without building a tolerance first

The same goes for edibles. Cut them in half or even a third to start with. Remember it can take up to 2 hours for edibles to work, so don't take more or you may experience unwanted side effects. I could successfully microdose edibles 2-4 times daily, depending on need.  

Topicals are amazing and work! I prefer the ointment over creams and gels, but the costs can add up. You can make your own inexpensive topical by mixing a tincture with a favorite ointment or cream.  

For first time users, I don’t recommend smoking marijuana flower or buds until you've first built-up tolerance with a 1:1 tincture or edibles. Smoking has a much faster mode of action and it can be difficult to manage the unwanted side effects.  

If you're willing to experiment, I recommend smoking at night at home when you have no responsibilities. I found that was best. Start slowly with one very small hit, it doesn't take much. Wait approximately 15-20 minutes before deciding to inhale a second or third hit. The side effects can be bad if you smoke too much, especially if you haven't built up tolerance.  

Always research the side effects and talk with staff at the dispensary. They can help with selecting flower or edibles that have pain, sleep, and mood helping properties. 

If you live in a state where medical marijuana is legal, get a license or card to protect yourself from discrimination, pain management contracts, and urine drug tests. I informed my providers and gave them a copy of my license to put in my medical health records.  

Before you use marijuana, be sure to talk with your prescribing provider, as you don't want to unintentionally breach your pain contract. If you smoke at home, landlords may also be an obstacle. 

The war on drugs propaganda is only meant to illicit fear. Educate yourself about the benefits of marijuana. It's not a gateway drug. Utilized responsibly, with the right strain, dose and preparation, marijuana can help reduce pain, inflammation and anxiety. It is absolutely worth trying.   

Lastly, don't give up! 

Christine Kucera lives with psoriatic arthritis, spondyloarthropy, spondylitis, polyarthritis, sacroiliitis, degenerative joint disease, dermatomyositis, mixed connective tissue disease, spinal radiculopathy, hypoparathyroidism, rare endocrine tumors, psoriasis, endometriosis stage IV, pelvic adhesive disease, and other painful conditions.

Prior to becoming disabled, Christine was a healthcare research systems developer and analyst for federally funded CMS, AHRQ, and NIH grants and programs.

Canada Seeks Feedback on Proposed Opioid and Cannabis Guidelines

By Pat Anson, PNN ditor

Health officials and pain management experts in Canada are seeking public feedback on proposed changes to Canada’s 2017 opioid prescribing guideline. They’re doing it through an online survey, with responses accepted not only from Canadians, but from providers, patients, caregivers and policymakers in the United States and other countries.

“We are very happy to receive feedback from both Canadians and Americans,” says Jason Busse, DC, a clinical epidemiologist and professor of anesthesia at McMaster University. “We are still in the process of drafting the guidelines, as the feedback we receive will affect these documents.”

Busse is leading a panel at McMaster’s Michael G. DeGroote National Pain Centre that has developed 11 draft recommendations for a revised opioid guideline. Survey respondents are being asked whether they agree or disagree with the recommendations, which focus on whether opioids should be a first line treatment for people with chronic non-cancer pain.

Consistent with the current guideline, the panel believes there are several non-opioid treatments that are just as effective as opioids and have less risk of adverse events. It also strongly recommends that opioids not be given to people with a history of opioid overdose, substance abuse, or mental health problems. For pain sufferers without such a history, the panel recommends “discussing a trial” of opioids if nonopioid treatments haven’t lessened their pain.

If opioids are prescribed, the panel suggests avoiding daily doses higher than 80 morphine milligram equivalents (MME), and strongly recommends against doses higher than 150 MME.  The estimated risk of a fatal overdose at 80 MME is relatively low at 0.23% (2.3 overdoses for every 1,000 people) and at 150mg MME is 0.5% (5 in 1,000).

The 80/150 MME recommendations are a substantial change from Canada’s current guideline, which suggest that initial doses of opioids be less than 50 MME and that they not exceed 90 MME.

For people in pain who are stable on long-term opioid therapy, the panel recommends that clinicians “initiate a discussion” of tapering to a lower dose, potentially including discontinuation. If the patient refuses, the panel recommends that another “discussion” be repeated every 6 to 12 months. Forced or involuntary tapering is not recommended.

“The Guideline Panel has formulated their recommendations based on current evidence and the values and preferences of people living with chronic pain. We are seeking public feedback on the current wording of the recommendations and associated remarks. We will review all feedback received in order to further optimize the wording and clarity of the recommendations and remarks,” Busse said in an email to PNN.

To take the opioid survey, click here.

Medical Cannabis Survey

A second survey is also being conducted by the National Pain Centre to help formulate a Canadian guideline for treating chronic pain with medical cannabis. As with the first survey, this one is open to everyone, regardless of where they live.

There are currently four draft recommendations for cannabis. The panel recommends a “trial of cannabis” for chronic pain only if a patient has tried other therapies that haven’t worked. The panel says there is evidence of small improvements in pain, physical function and sleep when cannabis was used.

Smoking cannabis is not recommended. The panel suggests that patients start with low doses of cannabis taken orally in oils and soft gels or inhaled through a vaporizer. Doses can be increased, depending how a patient responds.

Another recommendation is that cannabis be used by patients as a substitute for opioids or to help taper them to lower doses. The panel says “there is little to no difference” in effectiveness between cannabis and opioids, but that cannabis has far less risk of adverse events.

To take the cannabis survey, click here.  

Both surveys will take about 20 minutes to complete and will remain open until 12pm ET, February 29, 2024.

FDA Finds ‘Credible Scientific Support’ for Marijuana as Pain Reliever

By Pat Anson, PNN Editor

It took a lawsuit to prompt its release, but the U.S. Department of Health and Human Services (HHS) has finally made public a lengthy FDA review explaining why it thinks marijuana should be rescheduled as a Schedule III controlled substance. Such a move would make it legal under federal law for marijuana to be used for medically approved purposes, such as pain relief.

The FDA review was completed last August, nearly a year after it was requested by President Biden. But the 252-page review was not released until Friday, after a lawsuit was filed by two pro-cannabis lawyers when HHS didn’t respond to Freedom of Information Act (FOIA) requests.

Medical marijuana is already legal in 38 states, but cannabis remains classified as a Schedule I substance by the Drug Enforcement Administration, making its sale or use illegal under federal law. The DEA is expected to make its decision on rescheduling soon.

The FDA looked at seven potential medical uses of cannabis: pain, anorexia, anxiety, epilepsy, inflammatory bowel disease (IBD), nausea, and post-traumatic stress disorder (PTSD).

After reviewing clinical studies of cannabis, and the views of academic and professional medical societies, the FDA said they found “mixed findings of effectiveness.” The strongest evidence was for pain relief, anorexia and nausea.

“The available data indicate that there is some credible scientific support for the use of marijuana in the treatment of pain.”

— FDA review

“The largest evidence base for effectiveness exists for marijuana use within the pain indication (in particular, neuropathic pain),” the FDA said. “On balance, the available data indicate that there is some credible scientific support for the use of marijuana in the treatment of pain, anorexia related to a medical condition, and nausea and vomiting, with varying degrees of support and consistency of findings.”

Perhaps just as importantly, the FDA found no evidence of “unacceptably high safety risks” when marijuana was used therapeutically. That is a key finding for marijuana to be rescheduled by the DEA. The risk of marijuana being used nonmedically was also low, compared to substances like alcohol, heroin, cocaine, prescription opioids and anti-anxiety drugs.

“The rank order of the comparators in terms of greatest adverse consequences typically places heroin, benzodiazepines and/or cocaine in the first or immediately subsequent positions, with marijuana in a lower place in the ranking, especially when a utilization adjustment is calculated. For overdose deaths, marijuana is always in the lowest ranking among comparator drugs,” FDA said.

“These evaluations demonstrate that there is consistency across databases, across substances, and over time that although abuse of marijuana produces clear evidence of a risk to public health, that risk is relatively lower than that posed by most other comparator drugs.”

The FDA said the “vast majority” of professional medical organizations do not recommend marijuana, but they don’t specifically recommend against it either. The lone exception is the American Psychiatric Association, which warns that long-term use of marijuana can worsen psychiatric conditions, such as paranoia and hallucinations.

Reclassifying marijuana as a Schedule III substance – in the same category as codeine and ketamine – would certainly be historic, but it won’t resolve the many differences between federal and state regulation of cannabis.

Under federal law, legal access to Schedule III substances requires a prescription from a licensed doctor that is dispensed from a licensed pharmacy. Medical marijuana products would also have to go through the FDA’s lengthy and costly clinical trial process to assess their safety and effectiveness. Even if they pass that test, they would only be approved by FDA for certain conditions.  

CBD Ineffective for Osteoarthritis Knee Pain

By Pat Anson, PNN Editor

Cannabidiol (CBD) is often touted as an effective pain reliever for arthritis. Studies on animals and anecdotal reports from humans suggest that CBD – the non-psychoactive compound in cannabis -- has anti-inflammatory and pain-relieving effects on joint pain.

But in one of the first randomized, placebo-controlled clinical trials of CBD, researchers at Medical University of Vienna found that CBD is not an effective pain medication for knee osteoarthritis, even at high doses.

The study included 86 men and women who suffered from severe pain due to knee osteoarthritis,  a progressive condition caused by the breakdown of joint cartilage.in the knee. About 10 percent of people over age 60 have knee osteoarthritis (OA).

Half the participants received daily doses of CBD in capsules for eight weeks, titrating up to 600mg per day, which is considered a high dose. The other participants were given placebo capsules with no active ingredient. Neither group knew what they were taking.

The study findings, published in The Lancet Regional Health -- Europe, show that CBD did not have a stronger analgesic effect than the placebo. Adverse events were more common in the CBD group, with over half the participants (56%) reporting diarrhea, abdominal pain, fatigue and other mild side effects.

“Our results do not support the yet clinically unproven hopes for CBD as potential supplement or even replacement of potent analgesics, including opioids,” wrote lead author Sibylle Pramhas, MD, Department of Special Anesthesia and Pain Medicine at MedUni Vienna.

"Our study is the first to provide solid information on the lack of analgesic potential of CBD in a common chronic pain condition, due to the comparatively high oral dosage and the long observation period.”

This isn’t the first time CBD came up short in a clinical study. In 2017, Zynebra Pharmaceuticals tested a CBD gel for knee OA with mixed results. The Phase 2 study did not meet its primary goal of reducing the average pain score, although there were some indications the gel improved function and reduced pain severity. The company has since abandoned plans to use the gel for arthritis pain.

A more recent study of a CBD patch for knee osteoarthritis was withdrawn due to “inadequate funding.” Several other clinical studies of CBD for OA pain are underway or recruiting participants, but no results have been posted.

Currently, osteoarthritis knee pain is treated with analgesics such as acetaminophen (paracetamol), diclofenac, ibuprofen or tramadol. For the time being, they may be the best alternatives for pain relief.   

"CBD is not an alternative for pain therapy for osteoarthritis of the knee, so the search for more effective options must continue," says Pramhas.

Is It Safe for Doctors to Recommend Medical Cannabis?

By Dr. Joseph Parker

Nearly two-thirds of oncologists and pain management specialists say they are worried about the legal repercussions of recommending medical cannabis to their patients. This is not an unreasonable fear.

According to one survey, 60% of doctors fear professional stigma, and for good reason. I have seen colleagues call the DEA to report that a physician who certified patients for cannabis was selling marijuana from their office.  As absurd as this might seem, once the DEA gets rolling, they can always find an excuse to prosecute a physician treating pain or addiction. 

Cannabis may soon be moved from a Schedule I controlled substance, with no approved medical use, to a less restrictive Schedule III, where it would be regulated like codeine. This might relax some of those physicians, but I’m not sure it will.

There are many politicians and law enforcement officers who simply believe that marijuana is evil. The extreme was former Attorney General Jeff Sessions, who said at one time that marijuana was “only slightly less awful” than heroin. 

Sessions may truly believe this, but the comparison has no basis.  Heroin can cause respiratory depression and death.  Cannabis cannot.  Heroin works on the endorphin receptors in the brain to trigger a dopamine-mediated reward response, which can lead to what I call “true” addiction. 

Cannabis works predominately through the endocannabinoid system, though it can indirectly influence the release of dopamine and other brain areas associated with the reward system. That’s because the endocannabinoid system and CB1 receptors play a regulatory role in the release of various neurotransmitters, including dopamine.

When tetrahydrocannabinol (THC) binds to CB1 receptors, it can affect the release of dopamine and other neurotransmitters, which contributes to the pleasurable and rewarding effects associated with cannabis use.

I am not saying that someone cannot develop a cannabis substance use disorder or dependence. They certainly can, just like you can with caffeine, sugar or gambling, for that matter.  What I’m saying is that cannabis can make people feel good and want more, but it is nowhere near as dangerous as heroin.  It is also not neurotoxic, like methamphetamine, which can cause the death of brain cells with a single use. 

Some studies actually show a neuroprotective effect from cannabis. And, when taken by itself, cannabis cannot cause an overdose death. This is important. 

Every time the U.S. government targets something, they pay an army of statisticians to generate scary-sounding numbers. For example, you will hear claims that a rise in fatal car accidents was “associated” with cannabis. What exactly does that mean?  It means that a large percentage of accidents involve people who use cannabis, which is unsurprising since about 40% of the adult U.S. population has or is using cannabis.

Those same accidents show a much higher correlation with caffeine.  Caffeine use could be “associated” with probably 90% of all car accidents.  But correlation, of course, does not prove causation. 

These arguments present no evidence that cannabis caused the accidents.  However, the news media can get sloppy about scientific accuracy.  A study will say that a certain number of accidents “involved” cannabis, and the media will report that the cannabis “caused” the accident.

CBD vs. THC

For some reason, Sessions was also obsessed with CBD (cannabidiol). CBD is not THC, which is psychoactive and has a significant effect on a user’s mental processes.  CBD is considered non-psychoactive by a majority of experts, including the World Health Organization.

THC has a higher affinity for CB1 receptors, which are primarily found in the brain and central nervous system, and is a partial agonist for both CB1 and CB2 receptors. Activation of CB1 can cause euphoria and relaxation. It also alters sensory perception, impairs short-term memory, induces anxiety and paranoia, and impairs motor coordination.

CBD does not directly activate those receptors or have those effects. It is instead considered a negative allosteric modulator of CB1 receptors. CBD modifies the CB1 receptor response to THC and actually moderates some of the psychoactive effects of THC.  

There is also evidence that CBD can be anxiolytic and antipsychotic, while THC has been linked (not proven) to be associated with schizophrenia and psychosis.  THC can lead to the release of dopamine, which accounts for the euphoria, but at too low a level to be compared with more addictive substances.

CBD has been found in at least one study to be effective in the treatment of heroin addiction, and in another study to increased motivation, possibly giving us something to treat symptoms of schizophrenia.

Does this all mean it is safe to recommend cannabis to your patients?  Not really. While cannabis has been shown in several replicated studies to be helpful in the treatment of chronic pain, right now it is not safe for doctors to prescribe or recommend. 

Even in states where cannabis is legal for medical use and federal courts have upheld the right of physicians to recommend it, I would argue that the DEA takes a different view.

In the recent prosecution of a physician for “overprescribing” opiates, prosecutors claimed at a press conference that they started investigating the doctor after a call from local police regarding an overdose death.  Evidence later showed this was not the case.  The doctor was actually first targeted for agreeing to certify patients for their state’s medical cannabis program. 

You can help educate your patients about cannabis, but send them on to someone who does not prescribe controlled substances. Until physician rights are restored and protected in this country, it’s just not safe to recommend cannabis.

Joseph Parker, MD, is Chief Science Officer and Operations Officer at Advanced Research Concepts, a company developing solutions to the challenges of space travel and space-related medical issues.  In clinical practice, Dr. Parker specialized in emergency medicine and served as Director of Emergency Medicine at two hospitals. Prior to that, he had a distinguished career in the U.S. Marines and Air Force. 

In 2022, a federal jury convicted Dr. Parker on two counts of unlawful opioid prescribing. He has filed an appeal as he awaits sentencing.

Most Employees Want Insurers to Cover Medical Cannabis

By Pat Anson, PNN Editor

A new survey highlights the divide that often exists between patients, doctors and employers when it comes to using medical cannabis.

EO Care Inc. surveyed 1,027 Americans on their views and use of cannabis. All respondents were employed, either full or part-time, and lived in states where cannabis is legal for medical and/or recreational use.

Nearly one in five (18%) said they had used cannabis for health reasons in the past year, primarily for pain, anxiety, and to help them sleep. A large majority --- 88% --- said it helped them reduce their use of prescription drugs, alcohol or both.

Medical cannabis is so popular that 56% of workers said they would be more likely to take a job at a company that has a health plan that covers cannabis. And nearly half (44%) said they would reconsider applying for a job at a company that tested employees for cannabis or prohibited its use outside the workplace.

Nearly two thirds (65%) said they would feel more comfortable using medical cannabis if they were screened and dosed by a physician. And over half (51%) said they would be likely or very likely to use cannabis if it was covered by their insurer.

Previous surveys have found that doctors and patients are often reluctant to discuss cannabis. Many patients fear they’ll be labeled as drug abusers and lose their jobs if they admit using cannabis; while many doctors don’t consider themselves educated enough to recommend cannabis or have doubts about its safety and effectiveness.

“Finding clinical guidance for medicinal cannabis is difficult because most doctors lack the knowledge and retail dispensaries are not equipped to provide medical advice,” Sean Collins, co-founder and CEO of EO Care, said in a news release. “As a result we have tens of millions of Americans using cannabis for health reasons without guidance on specific product recommendations, dosage amounts, possible drug interactions, or consideration of their health history and other potential health risks.”

EO Care provides its members with access to clinicians who, based on a patient’s needs and medical history, develops a personal cannabis plan for them that includes recommendations for specific CBD and THC products and dosages. Members gain access to EO Care through employers who offer the program as a health benefit.

The company is trying to convince employers that offering cannabis care will help attract and retain good workers. Unguided cannabis use can lead to health issues, bad reactions or even abuse, leading to more sick days and loss of productivity.

“We know a large percentage of Americans have used cannabis in the past year, so this is definitely impacting employees and health outcomes,” said Collins. “With the right medicinal cannabis guidance, employers have an opportunity to help their employees, improve health outcomes and be progressive leaders in offering this important benefit that employees will come to expect.”

Currently, most employers and insurers don’t offer cannabis care, but attitudes are changing. A state court in Pennsylvania recently ruled that workers’ compensation plans must cover medical cannabis when an employee uses it to recover from a workplace-related injury. The court ruled that employees in Pennsylvania had “a statutory right” under state law to be reimbursed for medical cannabis.

Rescheduling Won’t End Conflict Between Federal and State Marijuana Laws

By Paul Armentano, Guest Columnist 

Ten months after the Biden administration requested the Department of Health and Human Services (HHS) “to initiate the administrative process to review expeditiously how marijuana is scheduled under federal law,” Secretary Xavier Becerra confirmed that the agency has recommended cannabis be removed from its Schedule I classification and placed in a lower schedule.

While the explicit details of HHS’ recommendation are not public, Bloomberg reports that the agency seeks to have cannabis moved to the less restrictive Schedule III of the federal Controlled Substances Act. 

The HHS recommendation now goes to the Drug Enforcement Administration, which will conduct its own scientific review. In the past, the DEA has employed its own five-factor test (which differs from HHS’ criteria) to determine whether or not cannabis ought to be rescheduled. On four prior occasions, most recently in 2016, the agency determined that cannabis failed to meet any of its five criteria.  

While it remains unknown at this time how the DEA will ultimately respond to HHS’ request, many are already speculating about the potential implications of such a policy change. And while some entities, particularly those involved in the commercial cannabis industry, have lauded the proposed change as a “giant” step forward, others – like myself – have been far more restrained.

That’s because reclassifying cannabis from Schedule I to Schedule III is neither intellectually honest, nor does it sufficiently address the widening chasm between state and federal marijuana laws. 

Specifically, reclassifying cannabis to a lower schedule within the CSA continues to misrepresent the plant’s safety relative to other controlled substances such as oxycodone and hydrocodone (Schedule II), codeine and ketamine (Schedule III), benzodiazepines (Schedule IV), or alcohol (unscheduled). More importantly, rescheduling marijuana fails to provide states with the explicit legal authority to regulate it within their borders as best they see fit, free from federal interference.  

To date, 38 states regulate the production and distribution of cannabis products for medical purposes. Twenty-three of these states regulate the possession and use of marijuana for adults. All of the state laws are currently in conflict with federal marijuana laws. Rescheduling cannabis to Schedule III will not change this reality. 

That’s because Schedule III substances are regulated only for prescription use by the federal government. That means legal access to these substances is limited to patients who possess a prescription from a licensed physician and who have obtained the product from a licensed pharmacy.

Currently, no state government regulates cannabis in such a manner – nor is it likely that any state will reconstruct their existing laws and regulations to do so in the future. 

Simply put, if marijuana is rescheduled, state laws authorizing citizens to possess cannabis for either medical or social purposes will continue be in violation of the federal law, as would the thousands of state-licensed dispensaries that currently serve these markets. And the DEA would still possess the same authority it has now under federal law to crack down on these state-regulated markets should it elect to do so. 

Some have suggested that rescheduling the cannabis plant may provide greater opportunities for investigators to conduct clinical research into its eventual drug development, but this result is also unlikely. That is because many of the existing hurdles to clinical cannabis research, such as the limits placed upon scientists’ access to source materials, are marijuana-specific regulations and predate cannabis’ Schedule I classification.

Other impediments, such as requiring the US Attorney General to approve marijuana-specific research protocols are statutory and are not specific to marijuana’s scheduling in the CSA. 

For these reasons, the National Organization for the Reform of Marijuana Laws (NORML) holds the position that the only productive outcome of the current scheduling review would be a recommendation to deschedule cannabis – thereby removing it from the Controlled Substances Act altogether and providing states with greater discretion to establish their own distinct marijuana policies. (A case in point: In 2018 Congress removed from the CSA hemp plants containing no more than 0.3 percent THC, as well as certain cannabinoids derived from them.)

Descheduling would remove the threat of undue federal intrusion in existing state marijuana programs and would respect America’s longstanding federalist principles allowing states to serve as “laboratories of democracy.”

By contrast, rescheduling simply perpetuates the existing contradictions between state and federal cannabis laws, and it fails to provide any necessary legal recognition from the federal government to either the state-licensed cannabis industry or those adults who use the plant responsibly in compliance with state laws.

Paul Armentano is the Deputy Director for NORML, the National Organization for the Reform of Marijuana Laws.

HHS to DEA: Marijuana Is Not Heroin

By Pat Anson, PNN Editor

The top U.S. health agency is asking the Drug Enforcement Administration to reclassify marijuana as a Schedule III drug under the Controlled Substances Act, putting cannabis in the same risk category as codeine, ketamine and steroids. Marijuana is currently classified as a Schedule I substance, the same as heroin and LSD.  

Bloomberg News was first to report that a top administrator in the Department of Health and Human Services (HHS) wrote a letter to DEA Administrator Anne Milgram asking for the change. Although 38 states and the District of Columbia have legalized recreational or medical marijuana, it remains illegal under federal law.

President Biden asked HHS Secretary Xavier Becerra nearly a year ago to review marijuana’s legal status, saying the classification of marijuana on the same level as heroin “makes no sense” and that people shouldn’t go to jail for marijuana possession.

“I can now share that, following the data and science, @HHSGov has responded to @POTUS’ directive to me for the Department to provide a scheduling recommendation for marijuana to the DEA. We’ve worked to ensure that a scientific evaluation be completed and shared expeditiously,” Becerra posted on Twitter Wednesday.

Although the Biden administration favors the move, rescheduling will not be a slam dunk. Marijuana falls under the jurisdiction of the Department of Justice, not HHS, and Milgram reports to Attorney General Merrick Garland, not Becerra. Conservative states where marijuana remains illegal are also likely to oppose the move.

Rescheduling has long been the goal of marijuana advocates, but some are disappointed that HHS is recommending it be moved to Schedule III, where it will still be regulated as a controlled substance.

“The goal of any federal cannabis policy reform ought to be to address the existing, untenable chasm between federal marijuana policy and the cannabis laws of the majority of US states. Rescheduling the cannabis plant to Schedule III of the US Controlled Substances Act fails to adequately address this conflict,” said Paul Armentano, Deputy Director of NORML, a marijuana advocacy group.

“Just as it is intellectually dishonest to categorize cannabis in the same placement as heroin, it is equally disingenuous to treat cannabis in the same manner as anabolic steroids. The majority of Americans believe that cannabis ought to be legal and that its hazards to health are less significant than those associated with federally descheduled substances like alcohol and tobacco. Like those latter substances, we have long argued the cannabis plant should be removed from the Controlled Substances Act altogether.”

The DEA will now conduct its own scientific review of marijuana. On at least four previous occasions, the DEA has refused to reschedule marijuana because there were inadequate safety studies and little scientific evidence supporting its use.

Another major hurdle under federal regulations is that before a substance can be used for a medical purpose, its “chemistry must be scientifically established to permit it to be reproduced in dosages which can be standardized.” That would imply that cannabis or pharmaceutical companies would need to produce marijuana medication in measured doses that are FDA approved and only available by prescription.

There is little consistency in labeling, regulating or testing of cannabis.products sold in states where it is legal. Many products are mislabeled, with concentrations of CBD (cannabinoids) and THC (tetrahydrocannabinol) that are well above or below their label claims.

“It will be very interesting to see how DEA responds to this (HHS) recommendation, given the agency’s historic opposition to any potential change in cannabis’ categorization under federal law,” said Armentano. “Since the agency has final say over any rescheduling decision, it is safe to say that this process still remains far from over.”

Although nearly a third of U.S. adults with chronic pain have used cannabis as a pain reliever, professional medical associations have been reluctant to endorse its use. In 2021, the International Association for the Study of Pain (IASP) released a position statement saying it could not endorse the use of cannabinoids to treat pain, citing too many “uncertainties” about the clinical evidence.

Illicit Drug Users Turn to Cannabis as ‘Safe Supply’ Option

By Pat Anson, PNN Editor

The cannabis industry and its advocates have long said that medical marijuana could help solve the opioid crisis by reducing demand for prescription opioids. While the evidence for that claim is somewhat mixed, a new study suggests that cannabis may be useful in reducing demand for illicit opioids, such as fentanyl.

Researchers at UCLA and the British Columbia Centre on Substance Use surveyed 205 people in Vancouver, BC who use cannabis and “unregulated opioids” obtained on the black market. In recent years, Vancouver has become a laboratory for harm reduction programs aimed at reducing overdoses, such as “safe supply” sites that offer prescription opioids and injectable heroin to drug users.  

The survey findings, published in the International Journal of Drug Policy, found that almost half the participants used cannabis to manage their opioid cravings and nearly 58% reported decreasing their opioid use. Researchers say the association between cannabis and harm reduction was “mainly driven by those living with moderate to severe pain.”

“These findings indicate that cannabis use to manage opioid cravings is a prevalent motivation for cannabis use among PWUO (people who use unregulated opioids) and is associated with self-assessed reductions in opioid use during periods of cannabis use,” wrote lead author Hudson Reddon, PhD, a Postdoctoral Fellow at the BC Centre on Substance Use.

The study is believed to be the first to investigate if illicit drug users can successfully manage their opioid cravings with cannabis. If the findings are confirmed, it could broaden access to cannabis as a harm reduction measure.

A previous survey of illicit drug users by the BC Centre on Substance Use found that about 1 in 4 used cannabis for harm reduction. About half used cannabis as a substitute for cocaine, methamphetamine and other stimulants (50%) and nearly a third used it as a substitute for illicit opioids (31%). Other reasons for using cannabis include coming off of other drugs (25%), substitution for a legal substance (15%), and as a treatment for withdrawal (15%).

“Given the increasing harm of the drug toxicity crisis and ongoing maturation of the regulated cannabis market in Canada, evaluating how cannabis use patterns, such as substitution, impact opioid use behaviours will be important to inform public health and policy responses to mitigate the harms of opioid use and evolving cannabis access,” Reddon wrote.

“Increasing the accessibility of cannabis products for therapeutic use may be a useful supplementary strategy to mitigate exposure to unregulated opioids and associated harm during the ongoing drug toxicity crisis.”

Medical Marijuana Laws Had Little Impact on Opioid Prescribing

By Pat Anson, PNN Editor

The cannabis industry and advocates in the U.S. have long claimed that state laws legalizing medical marijuana could help solve the opioid crisis by reducing demand for prescription opioids.

Various studies have suggested that may be true, like a recent one in New York state that found patients on high-dose opioids significantly reduced their opioid use once they started using medical cannabis. A similar study in 2021 found that cannabis was so effective in reducing chronic pain that most patients were able to reduce or completely stop their use of opioids.

But a large new study of commercially insured adults with chronic non-cancer pain found that the legalization of medical cannabis in 12 states (Arkansas, Connecticut, Florida, Louisiana, Maryland, Minnesota, North Dakota, New Hampshire, New York, Oklahoma, Ohio, Pennsylvania) had little to no effect on opioid prescribing.  

“Some research suggests that perhaps medical cannabis laws reduce opioid prescribing for chronic non-cancer pain because some people may substitute cannabis,” said lead author Beth McGinty, PhD, chief of the Division of Health Policy and Economics at Weill Cornell Medicine. “We found no effects of these laws on opioid prescribing or any types of treatment for chronic non-cancer pain that we looked at.”

McGinty and her colleagues looked at prescription data for over 150,000 chronic pain patients in the four years prior to state legalization and compared it to their medication use in the three years after medical marijuana laws were adopted. That data was then compared to prescription data for over 430,000 pain patients in 17 other states without medical marijuana laws, who served as a control group   

The study findings, published in Annals of Internal Medicine, show that opioid prescribing for chronic pain fell only slightly in states with medical marijuana laws, leading to tiny decreases in the average supply of opioids (0.35 fewer days) and for daily doses in morphine milligram equivalents (0.42 less MME). Small reductions were also noted in the prescribing of non-opioid pain relievers and in treatments such as physical therapy.

Importantly, the decreases were not substantially different than the data from states where medical marijuana remained illegal.

“Medical cannabis laws do not appear to be associated with changes in the prescription opioid or other non-cannabis, non-opioid treatments for chronic non-cancer pain,” McGinty said. “Policy makers trying to curb excess opioid prescribing and overdoses should focus on other strategies.”

Researchers say the minimal impact of medical cannabis on opioid prescribing may be due to the slow implementation of medical marijuana laws. Surveys show that most doctors are reluctant to discuss cannabis with their patients, and have doubts about its safety and effectiveness.

Doctors may not approve, but nearly a third of U.S. adults with chronic pain have used cannabis as a pain reliever and over half of them have reduced their use of pain medication. Many had no choice but to look for alternatives. Nationwide, opioid prescribing for commercially insured adults has fallen by 51% since 2011.

Primary Care Providers Still Reluctant to Talk About CBD

By Pat Anson, PNN Editor

Edibles, beverages and other products made with cannabidiol (CBD) went mainstream years ago, as public attitudes about cannabis changed and retailers discovered there was a growing market for CBD products.

The same is not true for primary care providers, according to a new survey that found most doctors are still reluctant to recommend CBD to their patients because of doubts about its safety and effectiveness. CBD is a chemical compound in marijuana that does not produce euphoria, but is believed to reduce pain and improve other health conditions.  

In the online survey of 236 primary care providers (PCPs) affiliated with the Mayo Clinic Healthcare Network in Minnesota, Wisconsin, Florida and Arizona, doctors said CBD was frequently brought up during medical appointments, usually by patients. But those conversations didn’t last long, because most PCPs don’t feel they have enough knowledge about CBD and are skeptical about CBD marketing claims.

PCPs in states where marijuana is legal are more receptive to patients using CBD products, while PCPs in states where marijuana is still illegal are more concerned about CBD’s side effects. But regardless of its legal status, most PCPs believe CBD is ineffective for most conditions for which it is marketed, with chronic non-cancer pain and anxiety/stress being the exceptions.

“Results from this mixed methods study show that PCPs practicing in the U.S. rarely screen for or discuss CBD use with their patients and report several barriers to engage in proactive CBD-focused practice behaviors,” wrote lead author Pravesh Sharma, MD, a pediatric psychiatrist and substance use researcher at Mayo Clinic Health System.

In a second, much smaller study, Sharma and his colleagues conducted interviews with 14 PCPs and found a number of barriers that prevent an open dialogue about CBD, including lack of time, discomfort, low-quality evidence, and CBD being a low priority.

“Our study is the first in-depth report on PCP attitudes, experiences, and practice behaviors related to CBD. The findings of our study have the potential to significantly impact future PCP practice behaviors,” they concluded.

The U.S. market for legal cannabis has grown into a $29.6 billion industry, but not much has changed over the years in terms of its acceptance in the medical community. In a 2020 survey of over 1,000 primary care patients in Vermont, only 18% rated their doctor as a good source of information about cannabis. Nearly half of the patients surveyed had used cannabis in the last year, and most of them thought cannabis was helpful for pain, anxiety, depression, arthritis, sleep and nausea.

The effectiveness of CBD is somewhat murky, because CBD products are poorly regulated and vary so much in dose, quality and whether they also have THC. While CBD may be effective temporarily in relieving pain and other symptoms, some researchers are concerned about its long-term effects on children and adolescents.  

“In fact, although CBD is widely available as an unregulated supplement, we researchers know almost nothing about its effects on the developing brain. Of note, these harms apply not only to smoking, but also to ingesting, vaping or other ways of consuming cannabis or its extracts,” Hilary Marusak, PhD, a psychiatry professor at Wayne State University, said in a recent column.

“In my view, it’s important that consumers know these risks and recognize that not everything claimed in a label is backed by science. So before you pick up that edible or vape pen for stress, anxiety, or sleep or pain control, it’s important to talk to a health care provider about potential risks.”

Unfortunately, asking a doctor may not provide many answers.

Cannabis Study Finds ‘Significant Improvements’ in Physical and Mental Health

By Pat Anson, PNN Editor

The use of medical cannabis was associated with “significant improvements” in physical and mental health in a large survey of Australian adults suffering from chronic pain and other health problems.

Over 3,100 people participated in the survey. Chronic non-cancer pain was the most common condition reported (68.6%), followed by cancer pain (6%), insomnia (4.8%) and anxiety (4.2%).  

Australia has relatively stringent rules for medical cannabis. Patients have to exhaust all other forms of treatment and consult with a physician, who reviews their medical history and suitability for cannabis before writing a prescription.

Most of the prescriptions for survey participants were for cannabis products taken orally, such as oils and capsules, with only a small number for dried cannabis flower. About 80% of the cannabis products were rich in cannabidiol (CBD), with the rest dominant in tetrahydrocannabinol (THC) or a balanced mix of CBD and THC.

Patients were asked to rate their wellness and quality of life in eight categories on a scale of 0-100, including general health, body pain, physical functioning, physical limitations, mental health, emotional limitations, social functioning and vitality. The surveys were conducted at the start of the study and then every 45 days after cannabis therapy was initiated, with a total of 15 follow up surveys.   

The study findings, recently published in JAMA Network Open, showed sustained improvement in all eight wellness categories after participants started taking cannabis, with body pain improving an average of 10 to 15 points on the 100-point scale. Researchers also found “pronounced and statistically significant improvements” in mental, social and emotional health.

“This study suggests a favorable association between medical cannabis treatment and quality of life among patients with a diverse range of conditions. However, clinical evidence for cannabinoid efficacy remains limited, and further high-quality trials are required,” wrote lead author Thomas Arkell, PhD, a psychopharmacologist at the Swinburne University of Technology in Melbourne.

Adverse events such as sleepiness and dry mouth were relatively common during cannabis therapy, but were usually mild or moderate.

Before starting cannabis therapy, patients were taking an average of nearly five medications a day, the most common being simple analgesics (54%), opioids (48%), antidepressants (45%), benzodiazepines (34%) and gabapentinoids (22%). The study did not examine if medication use declined once participants started taking cannabis.  

“While we cannot exclude the possibility that adverse events may have been caused in whole or part by the disease state and concomitant medications, the relatively high incidence of adverse events still affirms the need for caution with THC prescribing and careful identification of patients with contraindications,” Arkell wrote.

Medical cannabis was legalized in Australia in 2016. Since then, over 332,000 Australians have been given cannabis prescriptions, mostly for chronic pain (55%), anxiety (23%) and sleep disorders (6%).

Pain management experts in Australia have long taken a dim view of cannabis. In 2021, the Australian and New Zealand College of Anaesthetists released new guidance urging doctors not to prescribe medical cannabis for chronic non-cancer pain because of a lack of good quality research.

Cannabis Helps Relieve Cancer Pain

By Pat Anson, PNN Editor

Good news for patients suffering from cancer pain or side effects from cancer treatment. Two new studies found that medical cannabis helps relieve cancer pain, and offer some lessons to non-cancer patients about which cannabis products might work best for them.

The first study involved 358 adult cancer patients enrolled in a cannabis registry created by the Quebec Medical College. The patients were being treated for a variety of different cancers and were referred to the registry by their doctors. The primary complaint of most was pain (72%), with others experiencing symptoms such as nausea, anorexia, weight loss, anxiety and insomnia.

Participants were assigned to one of three groups, using cannabis products that were high in tetrahydrocannabinol (THC), high in cannabidiol (CBD), or a balanced blend of THC and CBD. The cannabis was ingested orally, through inhalation or a combination of the two. Patients were monitored and assessed every three months for a year.

The study findings, published in the journal BMJ Supportive & Palliative Care, show that pain levels dropped significantly after 3, 6 and 9 months, with pain slightly worsening after 12 months. Patients using balanced THC-CBD products reported the most pain relief, and many were able to reduce their use of opioids and other medications.

A small percentage of patients suffered adverse events from cannabis, such as sleepiness, dizziness and fatigue. Only 5 patients had side effects so severe that they stopped using cannabis.

Researchers concluded that medical cannabis should have a role as a complimentary pain management option in cancer patients who don’t get adequate relief from conventional analgesics.

“We found MC (medical cannabis) to be a safe and effective treatment option to help with cancer pain relief. THC:CBD balanced products appear to perform better as compared with THC-dominant and CBD-dominant products. Furthermore, we observed consistent decreases in medication burden and opioid use in our patient population,” researchers said.

Less Pain = Better Cognition

The second study, by researchers at University of Colorado Boulder, involved 25 cancer patients being treated by oncologists at the CU Anschutz Medical Campus. The patients’ pain levels, sleep patterns, cognition and reaction times were assessed at the start of the study; and they were asked to select edible products from a cannabis dispensary, such as chocolates, gummies, tinctures and baked goods containing different ratios of THC and CBD.

After just two weeks of regular use, patients reported less pain, better sleep, and the unexpected benefit of improved cognition – they were able to think more clearly.

“When you’re in a lot of pain, it’s hard to think,” said senior author and cancer survivor Angela Bryan, PhD, a professor of psychology and neuroscience at CU Boulder. “We found that when patients’ pain levels came down after using cannabis for a while, their cognition got better.”

The improved cognition didn’t happen right away. Patients who used edibles rich in THC got high from it and their cognition initially decreased. But after a few days of regular cannabis consumption, a new pattern emerged. Patients reported improvements in pain, sleep and cognitive function, including reaction times.

“We thought we might see some problems with cognitive function,” said Bryan. “But people actually felt like they were thinking more clearly.”

Patients who ingested edibles high in CBD reported bigger improvements in sleep quality and pain intensity.

Bryan’s study, published in the journal Exploration in Medicine, is one of the first to assess the efficacy of cannabis purchased at dispensaries — rather than less potent government supplied cannabis or synthetic cannabis medications that are primarily used to treat nausea.

Bryan had just begun studying medical cannabis in 2017, when she was diagnosed with breast cancer. After surgery and chemotherapy, she looked to cannabis for pain relief as an alternative to opioids. Neuropathic pain is a common side effect from chemotherapy.

Bryan used her own customized regimen of potent THC products when pain was intense and took mostly CBD products when the pain was more manageable. She was not completely pain-free, but she didn’t take a single opioid during treatment. She hopes others will learn from her experience.

“I was extremely lucky because I had some knowledge about this. Most patients don’t,” Bryan said. “People are open to trying whatever they think might be useful, but there's just not much data out there to guide them on what works best for what.”

As many as 40% of U.S. cancer patients use cannabis, but only a third of doctors feel comfortable advising them about it.

Melatonin and Cannabis Products Often Mislabeled

By Pat Anson, PNN Editor

If you use cannabis for pain relief or take melatonin to help you sleep at night, you may want to check the label and ask the manufacturer just how accurate the list of ingredients is.  Or think twice before buying it.

Two more studies are raising doubts about the accuracy of label claims on cannabis products and melatonin supplements, which are often marketed with unsupported claims about their health benefits.

In the first study, published this week in JAMA, researchers analyzed 25 melatonin gummy products, including 5 gummies that also contained cannabidiol (CBD). Melatonin is a natural hormone produced by the brain at night to help induce sleep. Supplements containing synthetic melatonin and/or CBD are often marketed as products that improve sleep, reduce anxiety, and promote relaxation.

Researchers found that only 3 of the 25 gummies contained enough melatonin to be within 10% of the labeled amount – with one product containing 347% more melatonin than what was listed, a potentially dangerous amount. Another gummy contained no melatonin at all, just CBD.

“The great majority of melatonin gummy products were inaccurately labeled, with most products exceeding the declared amount of melatonin and CBD,” wrote lead author Pieter Cohen, MD, an associate professor at Harvard Medical School and an internist at Cambridge Health Alliance. “Given these findings, clinicians should advise parents that pediatric use of melatonin gummies may result in ingestion of unpredictable quantities of melatonin and CBD.”

Pediatric use is concerning because calls to U.S. Poison Control Centers about children ingesting melatonin have increased five-fold over the past decade, resulting in nearly 28,000 emergency room visits, over 4,000 hospitalizations and two deaths.

Researchers say it takes just 0.1 mg to 0.3 mg of melatonin to increase plasma levels beyond the normal nighttime range in young adults. The amount of melatonin found in the gummies was much higher, including one product containing 13.1 mg of melatonin.

“Consuming melatonin gummies as directed could expose children to between 40 and 130 times higher quantities of melatonin,” they said. “With respect to CBD, the drug is FDA approved to treat refractory seizures caused by 3 rare genetic disorders, but the FDA has not approved the use of CBD for any indication in healthy children.”

The JAMA report is believed to be the first U.S. study to quantify the amount of melatonin in over-the-counter supplements. A 2017 Canadian analysis of melatonin products had similar findings, with the actual dose of melatonin ranging from 17% to 478% of the amount listed on the label. Neither the U.S. or Canadian studies identified the melatonin brands that were tested.

Too Little THC

It wasn’t too much, but too little tetrahydrocannabinol (THC) that University of Northern Colorado researchers found in 23 cannabis flower products purchased at state-licensed dispensaries. The study findings, recently published in the journal PLOS One, show that nearly 70% of the flower samples had THC levels at least 15% lower than what was listed on their labels.

Inaccurate labeling has long been a problem in the cannabis industry. Some growers and merchants resort to “lab shopping” to seek out product testing laboratories that generate the most desirable results – which means inflated levels of THC.  There’s a financial incentive to do so, because cannabis products containing high amounts of THC usually sell at a higher price.

One of the flower samples, purchased at a Denver dispensary and sold under the brand name “OG Kush 2,” had only half the amount of THC listed on its label.  

“Given our results it is urgent that steps are taken to increase label accuracy of Cannabis being sold to the public. The lack of accurate reporting of THC potency can have impacts on medical patients controlling dosage, recreational consumers expecting an effect aligned with price, and trust in the industry as a whole,” researchers said.

“Although we have no power to change the current system, we hope highlighting this issue and educating consumers will affect the change needed to remedy inflated potency of flower products. Addressing this discrepancy will require both changes to the regulatory system and consumer awareness that reported THC potencies are frequently inflated.”

Although 38 states and Washington DC have legalized medical or recreational cannabis, there is little consistency in labeling, regulating or testing cannabis. The researchers called for more regulatory oversight of cannabis and standardized testing protocols.