Cannabis Users Deserve Better Research

By Roger Chriss, PNN Columnist

This has been a challenging month for supporters of medical cannabis, with two professional pain societies – the Australian and New Zealand College of Anaesthetists and the International Association for the Study of Pain (IASP) both releasing statements saying they do not endorse the use of cannabis to treat pain.

IASP’s position statement came after a two-and-a-half-year review of cannabis studies by researchers at the University of Bath's Centre for Pain Research, who found little evidence to support the use of cannabis for pain control.

“Cannabis seems to attract strong opinions. If ever a field needed evidence and a rigorous scientific opinion it is this one. For many this will be an unpopular conclusion, but we need to face up to the fact that the evidence is simply lacking. Science is not about popularity but keeping people safe from false claims,” said Professor Christopher Eccleston, Director of the Centre for Pain Research

Eccleston and his colleagues published their findings in a series of 13 articles in IASP’s journal PAIN. They found that many cannabis studies had too few participants, tested a single-dose exposure in a laboratory, or the trials only lasted a couple of weeks. Such work can justify further research, but not the clinical use of a drug by patients, which requires long-term studies of safety and efficacy.

"Cannabis, cannabinoids, and cannabis-based medicines are becoming an increasingly popular alternative to manage pain. However, our review shows that there is limited evidence to support or refute their use for the management of any pain condition. The studies we found were poor quality and the evidence was of very low-certainty," said Dr. Emma Fisher of the University of Bath.

Although cannabis has been used for thousands of years for pain and other conditions, there are few good quality studies to support its use, as anesthesiologist Abdul-Ghalliq Lalkhen, MD, notes in his new book, “An Anatomy of Pain.”

“There have so far been only twelve randomized controlled trials on cannabis in the past five years, and most of these studies have indicated that cannabinoids are not effective in the management of neuropathic pain," wrote Lalkhen.

Even when cannabis studies are conducted, they often have disappointing results. Zynerba Pharmaceuticals had high hopes for developing CBD drugs and a transdermal CBD skin patch, but quietly dropped them after disappointing clinical trials.

“Zynerba’s drugs have struggled mightily in the clinic, missing key endpoints and sometimes failing to show dose-dependent responses. Plans for an epilepsy and osteoarthritis drug fell away with clinical failures in 2017. A year later, so did a patch that was meant to deliver their THC through the skin,” Jason Mast reported in Endpoints News.

The lack of good evidence was noted by the Food and Drug Administration when it recently warned two companies illegally marketing over-the-counter CBD products for pain relief:

“It’s important that consumers understand that the FDA has only approved one drug containing CBD as an ingredient. These other, unapproved, CBD products may have dangerous health impacts and side effects. We remain focused on exploring potential pathways for CBD products to be lawfully marketed while also educating the public about these outstanding questions of CBD’s safety,” said FDA Principal Deputy Commissioner Amy Abernethy, MD.

Even when high-quality, placebo controlled trials are conducted, they often fail to replicate the results of lower-quality studies. For instance, cannabis is often touted for post-traumatic stress disorder (PTSD). But a recent clinical trial of cannabis for PTSD found it worked no better than a placebo.

“No active treatment statistically outperformed placebo in this brief, preliminary trial. Additional well-controlled and adequately powered studies with cannabis suitable for FDA drug development are needed to determine whether smoked cannabis improves symptoms of PTSD,” researchers concluded.

The American Medical Association takes a similar view. “Scientifically valid and well-controlled clinical trials conducted under federal investigational new drug applications are necessary to assess the safety and effectiveness of all new drugs, including potential cannabis products for medical use,” the AMA said.

Cannabis users deserve high-quality research. And the medical community deserves respect for not endorsing cannabis before the evidence base is well established. Arguing over low-quality studies does not have the persuasive power of a high-quality clinical trial.

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.

Doctors Advised Not To Prescribe Cannabis for Chronic Pain

By Pat Anson, PNN Editors

Pain management experts around the world are becoming more vocal about the growing use of medical marijuana as a treatment for chronic pain, saying there is little evidence to support the use of cannabis as an analgesic.

Today the Faculty of Pain Medicine at the Australian and New Zealand College of Anaesthetists (ANZCA) released new guidance urging doctors not to prescribe medical cannabis for patients with chronic, non-cancer pain unless they are enrolled in a clinical trial.

“Until there are results from high-quality, unbiased clinical trials which establish the effectiveness and safety of medicinal cannabis in treating chronic pain, the Faculty of Pain Medicine does not believe cannabinoid products should be prescribed,” Mick Vagg, MD, Dean of the Faculty of Pain Medicine, said in a statement.  

“We want to highlight to healthcare providers that currently available medical cannabis products are not even close at this stage to showing that they deserve a place in the management of the complex patients who suffer from ongoing pain. We believe clinicians will welcome this clear guidance.”

ANZCA is a professional society for nearly 8,000 anesthesiologists and pain management specialists in Australia and New Zealand, and sets standards for pain medicine in both countries.

Australia and New Zealand have some of the highest rates of cannabis consumption in the world. But New Zealand only allows medical cannabis for terminally ill patients, while Australia requires a prescription for cannabis that is often difficult to obtain.

About one if five Australians live with chronic pain.   

Medical cannabis products are not even close at this stage to showing that they deserve a place in the management of the complex patients who suffer from ongoing pain.
— Dr. Mick Vagg

“By far the most common reason for the use of medicinal cannabis in this country is chronic pain − however there is a critical lack of evidence that it provides a consistent benefit for any type of chronic non-cancer pain, especially compared to the treatments we already strive to provide in pain clinics,” Vagg said.

“The research available is either unsupportive of using cannabinoid products in chronic non-cancer pain or is of such low quality that no valid scientific conclusion can be drawn. Cannabidiol-only formulations have never been the subject of a published randomised controlled trial for chronic pain treatment, yet they are the most commonly prescribed type of cannabis product.”

Vagg also said research is lacking in how cannabinoids react with pharmaceutical drugs, particularly in relation to their sedative and psychiatric side effects.

‘Hypothesis’ of Analgesia

ANZCA’s new guidance came just days after 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. IASP said there were preliminary studies supporting the “hypothesis of cannabinoid analgesia,” but not enough to overcome the lack of evidence on the safety and efficacy of cannabinoids.

“While IASP cannot endorse the general use of cannabinoids for treatment of pain at this time, we do not wish to dismiss the lived experiences of people with pain who have found benefit from their use,” said Andrew Rice, MD, chair of IASP’s Presidential Task Force on Cannabis and Cannabinoid Analgesia.

“This is not a door closing on the topic, but rather a call for more rigorous and robust research to better understand any potential benefits and harms related to the possible use of medical cannabis, cannabis-based medicines and synthetic cannabinoids for pain relief, and to ensure the safety of patients and the public through regulatory standards and safeguards.”

Rice said IASP was concerned that laws allowing the use of medical marijuana were being adopted without the same rigor and regulatory procedures that are followed for pharmaceutical products. Patients who self-treat their pain with cannabis are also at risk, according to Rice, because their doctors often don’t know about their cannabis use.  

“IASP is also calling for the delivery of a comprehensive research agenda. Priorities include identifying patients with pain who may receive the most benefit from cannabis or cannabinoids, and who may be at risk of the most harm,” said former IASP president Lars Arendt-Nielsen, MD, who co-chaired the Cannabis Task Force.

Supporters of medical cannabis dispute the contention that there is inadequate evidence about the use of cannabis for pain.

“These recommendations are political, not scientific. Several peer-reviewed trials have concluded that inhaled cannabis is safe and effective for treating various types of pain, in particular neuropathic pain,” Paul Armentano, Deputy Director of NORML, said in an email to PNN.

Armentano cited a 2017 study from the U.S. National Academy of Sciences, which found “conclusive or substantial evidence” that cannabis is an effective treatment for chronic pain.

“In the real world, the therapeutic use of cannabis is rising among chronic pain patients, many of whom are substituting it in place of opioids. In jurisdictions where cannabis is legally available, chronic pain is the most qualifying condition among medical cannabis patients enrolled in state-specific access programs. To willfully ignore these data is indicative that political considerations, rather than scientific considerations, influenced this group’s decision,” Armentano said.

Clarifying the New Definition of Pain

By Dr. David Hanscom, PNN Columnist

What is pain? We toss the word around a lot without really understanding – or defining -- what it actually means.

There are many different types and sensory levels of pain. A loud noise is uncomfortable. Bitter tastes are unpleasant. Ringing in your ears is more than annoying. Sometimes our feelings get hurt. Physical pain can be mildly irritating or crippling.

The way every living species evolved and survives is by processing these multiple types of sensory input and interpreting them as either safe or dangerous. Then its behavior is directed towards safety and reward, while also avoiding threat.

Short-term acute pain is a warning signal that indicates there is potential damage to a specific body part. Acute pain is necessary and protective. You might even call it a gift. People who are born without a pain system don’t often survive more than 10-15 years. They can’t sense danger. Tissues are destroyed and they die of infection.

But there is nothing useful about chronic pain. When a delicately balanced signaling system is out of kilter, it can no longer accurately interpret the environment. You become trapped by incredibly unpleasant sensations. Chronic pain may be one of the worst experiences of the human condition. It interferes with physical function, social interactions, and psychological well-being.

Recently, for the first time since 1979, the International Association for the Study of Pain (IASP) revised its definition of pain. This was made necessary by neuroscience research showing that pain could arise from sources other than physical tissue damage.

Old IASP definition: "An unpleasant sensory and emotional experience associated with actual or potential tissue damage or described in terms of such damage."

New IASP definition: "An unpleasant sensory and emotional experience associated with or resembling that associated with actual or potential tissue damage." 

Although the revision is a relatively small one, it has big implications for appreciating the complexity of pain. Adding the words “resembling” and “potential” allows for an expanded understanding and appreciation of pain beyond what was previously limited to actual tissue damage. 

Dropping the word "described" allows for recognition of pain in people who may not have the ability to effectively communicate their pain, such as infants, cognitively impaired individuals or those with speech and hearing disorders.  

Pain Is a Personal Experience That Should Be Respected

The new definition expands our understanding of pain in 6 key areas: 

  • Pain is a personal experience that is influenced to varying degrees by biological, psychological and social factors 

  • Pain cannot be inferred solely from activity in sensory neurons 

  • People learn the concept of pain through their life experiences 

  • Every report of pain should be respected 

  • Although pain often has a protective role, it may also have adverse effects on physical function, as well as social and psychological well-being

  • The inability to communicate pain does not negate the possibility that someone is feeling pain

It is logical that pain is personal because each person is genetically different and we are programmed with regards to safety vs threat by our past. If you come from a less than nurturing background, more things in the present will seem dangerous. You will spend more of your time in “high alert” – with a sustained exposure to stress hormones and inflammation that could lead to physical symptoms and illness.

Pain being a learned experience is well established in the medical literature. One classic study involved looking at childhood trauma. A scoring system was developed called the ACE score (Adverse Childhood Experiences) that looked at various kinds of physical and emotional trauma. Higher rates of chronic diseases, including chronic pain, are often associated with childhood trauma.

Since physical symptoms are created by the patient’s interaction with his or her environment, it is critical to know the person and their life circumstances. How can you solve any problem without deeply understanding it?

Unfortunately, mainstream medicine has not incorporated the last 20 years of neuroscience research into their treatment approach. It continues to recommend random simplistic treatments for a complex problem. It can’t and doesn’t work. The new IASP definition is a start and opens the door for a better treatment paradigm.

Chronic pain is solvable with a better understanding of it and informed principles behind the solutions. The starting point is for YOU to better understand it and then solve it while using the medical system as a resource. Once you take charge, it is game on.

Dr. David Hanscom is a retired spinal surgeon who now teaches back pain sufferers how to calm their nervous systems without the use of drugs or surgery. He recently launched a new website – The DOC Journey – to share his own experience with chronic pain and to offer a pathway out of mental and physical pain through mindful awareness and meditation.