Canada’s ‘Deeply Flawed’ Opioid Guideline

By Pat Anson, Editor

Just six months after adopting an opioid prescribing guideline modeled after the CDC's guideline in the United States, they’re already having second thoughts in Canada.

An editorial published in the Canadian Medical Association Journal says the guideline is “deeply flawed,” may have contributed to several deaths, and has created “a climate of fear” among doctors and patients.

Like the opioid guideline released by the Centers for Disease Control and Prevention in 2016, the Canadian version strongly recommends that patients not receive opioid doses in excess of 90mg morphine equivalents daily (MED), and that patients receiving a higher dose by tapered to the “lowest effective dose” or stop getting opioids altogether.

“The Guideline neglects to warn physicians that tapering can put patients at high risk for overdose, because patients will lose tolerance, experience distressing withdrawal symptoms, and turn to other sources for their opioid,” warns lead author Meldon Kahan, MD,  director of addiction treatment at Women’s College Hospital in Toronto.

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Kahan helped write Canada’s 2010 opioid guideline, which recommended a much higher ceiling of 200mg MED.  He says the current guideline fails to address addiction or how to treat opioid use disorder with medications such as buprenorphine and methadone.

“By not discussing these treatments, the Guideline encourages physicians to manage opioid addiction through tapering, which is usually ineffective and sometimes dangerous,” wrote Kahan.

“The Guideline is contributing to a climate of fear around opioid prescribing. We are aware of several instances of death following rapid tapering or abrupt discontinuation. The Guideline needs extensive revision to ensure patient safety; until this is done, the medical community and medical regulators must not use the Guideline as the standard for opioid prescribing.”

Over 50 clinicians, academics, patients and “safety advocates” helped draft the Canadian guideline. Among them were three board members of Physicians for Responsible Opioid Prescribing (PROP), an anti-opioid activist group that played a key role in drafting the CDC guidelines: PROP Vice-President Gary Franklin, MD, Mark Sullivan, MD, and David Juurlink, MD.

One major difference between the Canadian guideline and the CDC’s is that the latter is only intended for primary care physicians, while Canada’s guideline applies to all prescribers, including family physicians, pain specialists and nurse practitioners.

Nearly 1 in 5 Canadians suffer from chronic pain and Canada has the highest rate of opioid prescribing outside the United States. Opioid prescribing peaked in the U.S. in 2010, but prescriptions are still trending upward in Canada. A report released last week by the Canadian Institute for Health Information shows that the total number of opioid prescriptions rose by nearly seven percent between 2012 and 2016, although fewer pills are being prescribed.

Opioid overdoses are soaring in Canada, as they are in the United States, but increasingly the deaths involve illegal opioids such as heroin and illicit fentanyl, not prescription painkillers.

Minnesota’s Tough New Guideline

Canada may be having second thoughts about its guideline, but Minnesota appears close to adopting even tougher rules for prescribers – which would arguably be the most draconian anywhere in the United States.

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The draft guidelines released last week by the Minnesota Opioid Prescribing Work Group (MOPWG) would limit new opioid prescriptions for acute, short-term pain to just three days’ supply and a total of no more than 100mg MED – meaning the average daily dose would be less than 34mg MED.

Treatment for acute pain that lasts longer – for up to 45 days – would be limited to a total of 200mg MED every 7 days. Prescriptions would also have to be obtained weekly.

Daily doses for chronic pain lasting longer than 45 days would be limited to 90mg MED – if a patient is able to get them at all. The guideline specifically discourages doctors from prescribing opioids for fibromyalgia, migraine, “uncomplicated” back pain, and just about every other chronic pain condition. It also strongly recommends that  doctors discuss tapering with patients on long term opioid therapy, "regardless of their risk of harm."

“Opioid analgesics should not be used to manage chronic pain. There is very limited shorter-term evidence on the efficacy of opioids for chronic pain management and a growing body of evidence of significant harm associated with use,” the MOPWG said in a statement.

The MOPWG was chaired by Chris Johnson, MD, an outspoken critic of opioid prescribing who is a board member of PROP, as well as the Steve Rummler Hope Foundation.

“If pain doctors still think these medicines are effective, then they have a lot of explaining to do and their competence and professionalism deserve to be challenged,” Johnson said a few months ago.

If opioids are prescribed long term, Minnesota's guidelines recommend that doctors evaluate a patient’s mental health, as well as any history of physical or emotional trauma. The guidelines claim that patients with a history of trauma are more likely to develop chronic pain.

“Patients with chronic pain tend to report higher rates of having experienced traumatic events in their past, compared to people without chronic pain. A traumatic event is an event (or series of events) in which an individual has been personally or indirectly exposed to actual or threatened death, serious injury or sexual violence,” the guideline states.  

“Traumatic events illicit a number of predictable responses, including anxiety, physiological arousal and avoidance behaviors. A growing body of evidence finds that individuals who have experienced trauma may develop a persistently aroused or reactive nervous system. When confronted with an acute injury or pain following a surgical procedure, people whose nervous systems are already in a state of persistent reactivity due to a past trauma may be more likely to transition for acute to chronic pain.”

If adopted, Minnesota’s draft guideline would only apply to patients covered by the state’s Medicaid programs. However, they are expected to influence all prescribers, as well as insurance company policies and state regulatory boards. The guideline is available for public review and comment for the next 30 days.

The Media’s Addiction to Opioids

By Roger Chriss, Columnist

A recent and very brief CDC report described 59 pneumonia deaths in Minnesota between 2006 and 2015 that involved opioids. The gist of the study was that “opioid users are at increased risk for pneumonia” and therefore the deaths should have been reported as opioid related overdoses, even though the autopsy reports list pneumonia as the cause of death.

Vox said the study suggests “the opioid epidemic may be even deadlier than we think,” while the Daily Mail warned it was “just the tip of the iceberg” and that “we may have grossly underestimated the scale of the opioid epidemic.”

JAMA Surgery also recently published a study, which found that about 6 percent of surgery patients continued to use opioids more than three months after their surgery.

U.S. News cited the study to proclaim that “Many Opioid Addictions Surface After Surgery,” while MedicalXpress said it was proof that someone could go “from opioid-free to long-term user, in one operation.”

Both the CDC report and the JAMA Surgery study were grossly misrepresented. Fear sells, and the opioid crisis has become a favorite source of fear-mongering in the media.

The CDC report is a one page, four-paragraph document released by the agency’s Epidemic intelligence Service (EIS). It never mentions the words “addiction” or “epidemic,” yet it leaps to one very big conclusion.

“The total burden of opioid-associated deaths was underestimated in Minnesota,” the report says. “The contributions of opioid toxicity, infectious disease, or their interactions to death are challenging to disentangle; understanding these interactions might inform future opioid-related mortality prevention efforts.”

The JAMA Surgery article is a retrospective study which found an association between post-operative use of opioid medications for pain management and patient history of smoking and alcohol use. The study looked at opioid abuse only as an exclusion criteria for the patient population; it was not a study about addiction in any form. The JAMA article concludes by saying that “new persistent opioid use represents a common but previously underappreciated surgical complication that warrants increased awareness.”

In other words, we have intriguing results that should be investigated further, with the ultimate goal of improving public health and welfare. Unfortunately, all that is lost in the alarmist media coverage that mischaracterizes the findings, over-interprets the data, and extrapolates consequences to reach what at best are highly premature conclusions.

In its coverage of the CDC report, CNN quoted EIS officer Victoria Hall, DVM, as saying that the Minnesota data represents “an iceberg of an epidemic.” 

Keep in mind that Hall is not an epidemiologist, an infectious disease specialist or an expert on icebergs. She is a veterinarian by training and a recent graduate of Mississippi State University's College of Veterinary Medicine. Hall has been working for the CDC less than a year, according to her LinkedIn profile.

In a CDC media briefing, Hall refers to only one specific case in Minnesota: a middle-aged man dying of pneumonia, who was on opioid therapy for chronic back pain. This case is not mentioned in the CDC EIS report. His death may be an important hint of a new facet of the opioid crisis, or it may be an anomalous outcome. More work is needed to figure out what is really going on. For now, it bears remembering that the plural of anecdote is not data.

VICTORIA HALL, DVM

VICTORIA HALL, DVM

Similarly, U.S. News reported on the JAMA Surgery article by stating that, “Some surgery patients prescribed opioids for post-operative pain relief may face a high risk for developing a long-term opioid addiction, new research warns.” This report also appeared on Philly.com  and on WebMD , spreading the misinformation about addiction risks, which were never even mentioned in the article.

In other words, there was a huge and speculative leap from the data in the CDC report about 59 opioid-related pneumonia deaths over a decade-long period all the way to a stealth epidemic sweeping the nation. And an equally large jump from an association between the duration of post-surgical opioid use and patient social history to a new source of opioid addiction.

The sensible response is to call for further research. For the CDC, this means collecting data from all 50 states about otherwise unexplained deaths and seeing if opioids are involved in any of them, then following up with analysis on possible under-reporting. For the world of surgery, this means performing prospective trials to see if the reported association holds up, and then investigating if such use increases the odds of a patient developing opioid use disorder.

For now, we just don’t have the data to figure out what is going on. And as Sherlock Holmes says: “It is a capital mistake to theorize before one has data.”

Roger Chriss suffers from 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.

Pot for Pain Approved in Minnesota

By Pat Anson, Editor

After months of debate, Minnesota’s health commissioner has decided to include chronic pain in the list of conditions that allow residents to legally use medical marijuana. They just have to wait another nine months before they can buy it.

Commissioner Ed Ehlinger said it was “the right and compassionate choice” to allow pain patients into the program.  Only nine health conditions currently qualify for marijuana prescriptions in Minnesota – and chronic, intractable pain won’t be added until August 1, 2016. Health care providers can start certifying intractable pain patients on July 1 of next year.

Ehlinger, who is a physician, said “the existing tools are not working well” to manage pain, according to the Minneapolis Star Tribune.

“There are strong and conflicting opinions ... in both the professional community and in the general population. However, as a physician who is concerned about the treatment each individual patient receives and as the Minnesota Health Commissioner who is concerned about the overall health of everyone in this state, I believe that adding intractable pain to the list of qualifying conditions for our medical cannabis program is the correct decision,” said Ehlinger

Last month a state advisory panel recommended against the inclusion of chronic pain in Minnesota’s marijuana program, saying cannabis was not a “magic bullet” and there wasn’t enough evidence to support its use for pain.

“Panel members expressed concern that patients eligible to use medical cannabis for pain have expectations that it would provide total relief and that such a perception may leave patients to abandon other proven pain-management methods, such as physical therapy,” the recommendation said.

“Panel members cited the recent opioid crisis, where good medications were demonized because prescribers used it to treat pain without knowing its proper uses. Even after studying the information available on medical cannabis, panel members said providers do not feel prepared to certify patients for its use.”

Over a dozen public hearings on the issue were held across the state, and the vast majority of speakers favored including intractable pain in the list of health conditions marijuana can be used for.

Intractable pain is defined as “a pain state in which the cause of the pain cannot be removed or otherwise treated with the consent of the patient and which, in the generally accepted course of medical practice, no relief or cure of the cause of the pain is possible, or none has been found after reasonable efforts.”

The nine conditions that currently qualify for medical marijuana in Minnesota are cancer, glaucoma, HIV/AIDS, Tourette Syndrome, Amyotrophic Lateral Sclerosis (ALS), seizures, severe muscle spasms, Crohn’s Disease and terminal illness. In addition to strict limits on conditions it can be prescribed for, medical marijuana is not available in leaf form and cannot legally be smoked in Minnesota.  It is only legal in a pill, vapor or liquid form.

The limits are so restrictive, less than 800 patients have enrolled in the program so far. Enrollment is expected to increase dramatically once chronic pain is included.

"Congratulations to the State  of Minnesota for now becoming a true state of compassion," said Ellen Lenox Smith, a medical marijuana advocate and a columnist for Pain News Network.  "I do hope that in the near future, they will also consider to adjust their stand on cannabis being sold only in pill or liquid form — nothing smoke-able.  For those of us in Rhode Island, we can choose to vaporize, use topicals, smoke if that is your only way to make it work for you, along with tinctures, drinks and edibles. We all have to find the right way to make this medicine work for our conditions, so may they realize their limitations are very controlling and holding back pain relief for many."

Minnesota is one of 23 states and the District of Columbia where medical marijuana is legal.

Marijuana No ‘Magic Bullet’ for Pain in Minnesota

By Pat Anson, Editor

Minnesota may be one of 23 U.S. states where medical marijuana is legal, but getting a prescription for cannabis there is difficult – especially for chronic pain patients.

Since Minnesota enacted one of the nation’s strictest medical marijuana laws last year, less than 700 people have enrolled in the state’s cannabis registry. Only nine health conditions qualify for a marijuana prescription in Minnesota – and chronic pain isn’t one of them – a status that appears unlikely to change after an advisory panel voted 5-3 not to allow pain patients into the cannabis registry.

The reason? Medical marijuana is “not a magic bullet” and there’s not enough evidence that it can treat pain.

“Panel members expressed concern that patients eligible to use medical cannabis for pain have expectations that it would provide total relief and that such a perception may leave patients to abandon other proven pain-management methods, such as physical therapy,” the recommendation said.

“Panel members cited the recent opioid crisis, where good medications were demonized because prescribers used it to treat pain without knowing its proper uses. Even after studying the information available on medical cannabis, panel members said providers do not feel prepared to certify patients for its use.”

The panel recommended that marijuana not be prescribed to anyone with a history of substance abuse or patients with mental health problems. If marijuana is allowed for intractable chronic pain, the panel suggested that patients should be disqualified if they are under 21, have a history of psychosis, are pregnant or breast feeding.

The final decision is in the hands of Minnesota’s Health Commissioner, who has until the end of the year to decide if medical marijuana should be allowed for intractable pain.

The nine conditions that qualify for medical marijuana in Minnesota are cancer, glaucoma, HIV/AIDS, Tourette Syndrome, Amyotrophic Lateral Sclerosis (ALS), seizures, severe muscle spasms, Crohn’s Disease and terminal illness.

Terminally ill cancer patients – many of whom are in pain – are allowed to use medical marijuana. And many say they’ve been able to reduce their use of opioids since they started taking marijuana, according to the Minneapolis StarTribune.

“What are we going to do about patients? What do we tell patients who we know we can help, but we currently can’t help them? That’s the remarkably frustrating thing about this process that gets to me,” said Manny Munson-Regala, CEO of LeafLine Labs, one of the state’s two medical marijuana producers.

In addition to limits on the conditions it can be prescribed for, medical marijuana is not available in leaf form and cannot legally be smoked in Minnesota.  It is only legal in a pill, vapor or liquid form.