A Canadian Asks ‘Where the Hell Am I?’

By Ann Marie Gaudon, Columnist

I hear more and more stories like Elizabeth Matlack’s, a lifelong chronic pain sufferer who recently wrote about her problems getting adequate pain medication in Canada. (See “Who Benefits From My Suffering?”).

Not only do I live in a chronically pained body, I feel pain for her. I feel pain for all of those who struggle each and every day, who are now being medically abandoned. Imagine, the only thing any of them has ever done is to end up with a pained body. As I read these stories, there seems to be no stem to the flow. I am beginning to ask myself, “Where the hell am I?”

Just like Elizabeth, I am also Canadian. All my life I’ve lived here and felt so grateful for it. All my life I basically felt safe. I felt secure. I felt that my needs were looked after. I was damned proud of our medical system too. From a blood test to chemotherapy, whatever might come my way, I had faith that I’d be cared for and that I wouldn’t have to claim bankruptcy to get it.

I’ve known for many years that treatment for chronic pain has always been woefully inadequate. I held out hope that good people with good intentions would come to care about this too. In a safe place like Canada, surely it was just a matter of time.

Then I was aghast and insulted to hear that our very own prime minister said that chronic pain was “low grade, but very annoying.” In a cooperative place like Canada, surely someone will educate him to let him know the degree of suffering, disability and high rate of suicidality chronic pain patients have.

ANN MARIE GAUDON

ANN MARIE GAUDON

Won’t noble physicians with an intense desire to ease that suffering and do justice to their oaths come soon to advocate for us and improve our care? As I look around today, not seeing a trace of this, I am forced to ask myself, “Where the hell am I?”

I’ve lived enough years to know that people don’t generally do things for no reason and the reasons are plentiful. Money, fame, prestige, power, a moral sense of self-righteousness; there are a lot to choose from. Who benefits from a fabricated war on defenseless chronic pain patients while chasing the wrong crisis with a boat load of unproven assumptions?

Somebody somewhere does. You can be sure that there are too many hands in too many pockets to count. They all knew that chronic pain patients would be collateral damage, but the one thing they all have in common is they just don’t care.

Our Canadian government willingly let this happen under the disingenuous guise of “we have to protect you from your pain medications.” Imagine, you’ve been stable with nature’s gift of the most effective medication for your severe pain and now you can’t have it.

No Opioids Webinar

On the same day as I read about Elizabeth, I watched a webinar about how to treat chronic pain without opioids. The narrator was a physician who reportedly specialized in chronic pain. He was very efficient with his colour-coded columns of the categorizations of diseases and which treatments were suited to each.

Then something caught my eye. I noticed a chronic disease called interstitial cystitis was grouped together with pain central sensitization disorders. In bold font on the chart for this group was written: “NO Opioids!!”

Ironically, a few days before this, I was contacted by a woman diagnosed with this very disease. She was admitted into a hospital, where she emailed me. She wrote that a scope into her bladder revealed mass inflammation and lesions that the urologist described as “looking like cigarette burns throughout her bladder.” Her body was breaking down. Too much pain for too long. She was admitted with excessive sweating, soaring blood pressure, fever, and shaking uncontrollably.

It's likely her fight-or-flight response had become pathological in the face of intolerable, relentless pain. I have recently read that unrelieved pain complicates all other co-existing conditions through these stress mechanisms. She is also diabetic.

What would those who promote Canada’s new opioid guidelines -- which have made a mockery of chronic pain – suggest for this woman?  Would she be offered chiropractic care to make her right as rain? Perhaps Advil because that has an anti-inflammatory in it?

The webinar doctor made jokes along the way, such as “No one ever died from mindfulness.” So maybe we’ll start with meditation. She can’t think straight right now? Then maybe she should try yoga on her stretcher.

What became crystal clear watching the webinar is that these people don’t know a damned thing about chronic pain, especially severe pain. But so much worse yet – they don’t care to know -- so long as they get to pontificate about the demon opioid medication and the demons who have been taking them.  

The reality is that this woman has a significant risk of being dead soon. We know the guidelines have already played an unspeakable part in the deaths of chronic pain patients in the way of medical collapse and suicide. But no one seems to care about that either.

This isn’t the place that I grew up in. This isn’t the place where I felt safe, secure and cared for. This is an immoral place where those at the top serve their own political agenda. Yes, I said political because there’s no medical facts driving this out-of-control freight train.

This is an unethical place where the suffering are drop-kicked off a cliff and where the self-righteous and self-serving call down, “It sure sucks to be you.”

I don’t recognize Canada anymore. I’ve never lived in a place with such cruelty inflicted on such a vulnerable group. I didn’t grow up in a place with such a pervasive ultra-conservative meanness, where those in power exclusively serve themselves and to hell with the underdog – let them suffer until the bitter end.

Who benefits from Elizabeth’s suffering? Somebody somewhere does. As for the Canada I used to know and love, I can no longer see it or feel its reassurance. I guess I’ll have to continue to ask, “Where the hell am I?”

Because at this point, I just can’t figure it out.

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Ann Marie Gaudon is a registered social worker and psychotherapist in the Waterloo region of Ontario, Canada with a specialty in chronic pain management.  She has been a chronic pain patient for 33 years and works part-time as her health allows. For more information about Ann Marie's counseling services, visit her website.

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.

Who Benefits From My Suffering?

(Editor’s Note: This coming May will mark the one-year anniversary of Canada’s opioid prescribing guidelines, which discourage the use of opioid medication in treating non-cancer pain. Canada’s guidelines are very similar to the 2016 CDC guidelines in the United States and are having a similar impact on pain patients. Critics say the Canadian guidelines have created “a climate of fear” among patients and doctors, and may have contributed to several deaths.

Elizabeth Matlack is a 36-year old Canadian and cancer survivor who has lived with chronic pain literally her entire life. She recently wrote this open letter to Health Canada and Prime Minister Justin Trudeau.)  

By Elizabeth Matlack, Guest Columnist

June 15, 1981 was the day I was born. I cried a lot as a baby, but nobody knew why. 

Three years later, when I was old enough to talk and voice my problems, I told everyone that I couldn't sit down because it hurt too bad.  My mother knew something was wrong, but she just didn’t know what.  She took me to many doctors, only to be told that I was constipated and that laxatives would solve the problem. They didn’t.

Bless my mother’s heart, because she did not give up.  She continued taking me to doctors until a pediatrician had the good sense to do an x-ray and found a grapefruit-sized malignant tumor attached to my coccyx and spreading up my spine.  I was given a 10% chance of survival while they operated and removed the tumor. 

They would go on to remove my coccyx, and gave me over a year of chemotherapy and 28 days of cobalt radiation to what was left of my spine.   The damage done to my backside was permanent. The radiation destroyed every single fat cell, causing me to have a cavity where most have buttocks. 

Sitting is very painful for me. The best way to describe how it feels is to imagine yourself resting your elbow on a hard surface, allowing all of your weight to fall on that elbow. That is what it feels like to sit. I cannot sit or lay on any surface that is not completely cushioned.

Not only was the physical pain excruciating, there was the emotional pain of not having a butt, not being able to find any clothes that fit, and being called "No Bum Beth" in school.   

Sitting has always been the most painful thing for me, followed by  standing and walking.  The severe pain in my backside, down my right leg and up through my back is non-stop.  Every hour of every single day I am in pain so severe that it makes the most basic life functions difficult. 

ELIZABETH MATLACK

ELIZABETH MATLACK

Those are the reasons that I have been in pain management for over a decade.  I have been able to create a somewhat normal life for myself using opioid pain medication. OxyContin and morphine have given me the ability to do what I love most in the world, which is.to make art and walk my dog. The chemo and radiation robbed me of my ability to have children, but they did not steal my inspiration and artistic abilities.  

I have followed all of the rules set forth by my pain doctors, keeping my meds locked up, never sharing with anyone, never asking another doctor for drugs, and passing urine drug tests each month. But none of that matters now.  

The new guidelines set out by Health Canada have caused doctors to no longer treat patients based on their individual needs, but rather as a number based on the guidelines. For 5 years I was on the same dose of OxyContin and morphine. The regimen worked well for me and afforded me the ability to create all kinds of artwork. For the most part, I had a pretty decent and comfortable life -- until the guidelines came out.

In less than 6 months, I was tapered down to less than a third of the opioid dose that I was stable on for five years. The tapering was very fast and caused immense daily suffering on my part.  I do not remember the last time I have slept more than an hour at a time.  I do not have enough pain meds to get thru 24 hours of the day no matter how I work it. Every single day is a roller coaster of severe pain and withdrawal. 

My pain specialist no longer has the ability to treat me properly and I am routinely left without any pain medication, while my GP doctor tries to treat my very high blood pressure. When my pain was being managed, my blood pressure was fine.

I know life isn't easy and I definitely know it can be unfair.  But this sort of cruel and unusual torture that I am being put through is absolutely disgusting. I keep hearing about the "opioid crisis," but the only crisis I can see is all the legitimate pain patients going untreated and suffering, because legislators have their thumb on the doctors and doctors have too much at stake to risk treating patients properly. 

Health Canada says the opioid guidelines are voluntary and were never meant for pain management doctors, but rather for general practitioners and surgeons treating acute short-term pain.  Yet the pain clinics are being raided and told to enforce the guidelines no matter who the patient is and what is wrong with them.  I do not know how much longer my body can continue in this much pain.

I want to make sure that the truth gets out there. There are far too many people suffering and being denied proper medical care. And for what? Who wins? Who is benefiting from all of my suffering?  Who?

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Elizabeth Matlack is an artist and illustrator in Ontario, where she is best known by her artist pen name, Lizzy Love.

Pain News Network invites other readers to share their stories with us. Send them to editor@painnewsnetwork.org

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.

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.

CDC Releases More Faulty Research About Opioids

By Pat Anson, Editor

A new study by researchers at the Centers for Disease Control and Prevention estimates that opioid overdoses have shaved two and a half months off the average life span of Americans – a somewhat misleading claim because the study does not distinguish between legally obtained prescription opioids and illegal opioids like heroin and illicit fentanyl.

The research letter, published in the medical journal JAMA, looked at the leading causes of death in the U.S. from 2000 to 2015. Overall life expectancy rose during that period, from 76.8 years in 2000 to 78.8 years in 2015, largely due a decline in deaths from heart disease, cancer, stroke, diabetes and other chronic health conditions.

But deaths due to Alzheimer’s disease, suicide, liver disease, drug poisoning and opioid overdoses rose, collectively causing a loss of 0.33 years in life expectancy – most of it due to opioids.

“This loss, mostly related to opioids, was similar in magnitude to losses from all the leading causes of death with increasing death rates,” wrote lead author Deborah Dowell, MD, of the CDC’s National Center for Injury Prevention and Control.

“U.S. life expectancy decreased from 2014 to 2015 and is now lower than in most high-income countries, with this gap projected to increase. These findings suggest that preventing opioid related poisoning deaths will be important to achieving more robust increases in life expectancy once again.”

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Dowell was also one of the lead authors of the CDC’s 2016 opioid prescribing guidelines, which discourage physicians from prescribing opioids for chronic pain. She and her two co-authors in the JAMA study --  both of them CDC statisticians -- do not explain why they failed to distinguish between black market opioids and legal prescription opioids, a dubious use of statistics akin to lumping arsonists in the same category as smokers or Boy Scouts learning to build campfires.  

They also fail to even mention the scourge of heroin and illicit fentanyl sweeping the country, which now accounts for the majority of opioid overdoses in several states.  

But Dowell and her co-authors don't stop there. The say the actual number of deaths caused by opioids is “likely an underestimate” because information on death certificates is often incomplete and fails to note the specific drug involved in as many as 25% of overdose deaths. This is another disingenuous claim, because it fails to explain why the data on the other 75% of overdoses is faulty too. 

Epidemic of Despair

Other researchers have also tried to explain the disturbing decline in American life expectancy – which began over adecade ago for middle-aged white Americans. Princeton researchers Anne Case and Angus Deaton were the first to document that trend,  when they estimated that nearly half a million white Americans may have died early because of depression, chronic pain, suicide, alcohol and drug abuse, and other health problems – an epidemic of despair linked to unemployment, poor finances, lack of education, divorce and loss of social connections.

The evidence was right there for Deborah Dowell and her co-authors had they looked for it. The JAMA study found that over 44,000 Americans committed suicide in 2015, a 66% increase from 2000, and over 40,000 died from chronic liver disease or cirrhosis, another 66% increase. Opioid overdoses during that same period rose to 33,000 deaths. 

Which is the bigger epidemic?

As PNN has reported, the CDC ignored early warnings from its own consultant that the agency’s opioid guidelines were being viewed as “strict law rather than a recommendation,” causing many doctors to stop prescribing opioid pain medication. Chronic pain patients also feel “slighted and shamed” by the guidelines, and are increasingly suicidal or turning to street drugs. We’ve also reported that the CDC has apparently done nothing to study the harms or even the possible benefits the guidelines have caused since they were released 18 months ago.

Instead of going back in time and selectively mining databases to fit preconceived notions about opioids, perhaps it is time for the CDC to take a giant step forward and see what its opioid guidelines have actually done.

New Federal Task Force to Address Opioid Prescribing

By Pat Anson, Editor

The federal government is forming another advisory panel to study and develop "best practices" for treating acute and chronic pain. And for the first time, the feds are seeking nominations from the public for members to serve on the panel, who would represent pain patients and pain management experts.

The Pain Management Best Practices Inter-Agency Task Force was authorized by the Comprehensive Addiction and Recovery Act of 2016 – also known as the CARA Act – a landmark bill signed into law last year to address the nation's addiction and overdose crisis.

While much of CARA is focused on preventing and treating opioid addiction, the law also calls for the Department of Health and Human Services (HHS) to form a task force to recommend solutions to “gaps or inconsistencies” in pain management policies among federal agencies.

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Currently, the Centers for Disease Control and Prevention, Food and Drug Administration, Centers for Medicare and Medicaid Services, Department of Veterans Affairs, and the Department of Defense all have different regulations and guidelines for opioid medication.

“This Task Force represents a critical piece of HHS’s five-point strategy to defeat the opioid epidemic, which includes advancing the practice of pain management,” HHS Secretary Tom Price said in a news release.

“Top experts in pain management, research, addiction and recovery can help us reassess how we handle the serious problem of pain in America.”

The task force could have as many as 30 members representing a broad spectrum of interests in pain management, according to a notice being published in the Federal Register:

The members of the Task Force shall include currently licensed and practicing physicians, dentists, and non-physician prescribers; currently licensed and practicing pharmacists and pharmacies; experts in the fields of pain research and addiction research, including adolescent and young adult addiction; experts on the health of, and prescription opioid use disorders in, members of the Armed Forces and veterans; and experts in the field of minority health.

The Members of the Task Force shall also include… representatives of pain management professional organizations; the mental health treatment community; the addiction treatment community, including individuals in recovery from substance use disorder; pain advocacy groups, including patients; veteran service organizations; groups with expertise on overdose reversal, including first responders; State medical boards; and hospitals.

Members will also be appointed to represent Veterans Affairs, Department of Defense, Office of National Drug Control Policy, and “relevant HHS agencies.” The latter most likely includes the FDA and CDC. The Drug Enforcement Administration, an agency in the Department of Justice, will apparently not have a representative on the task force.

Pain patients and pain management experts have been poorly represented – and in some cases excluded – from previous federal advisory panels that addressed opioid prescribing and addiction. Some panel meetings were also closed to the public.

President Trump’s opioid commission, for example, includes three governors, a former congressman, and a Harvard professor who has been a longtime critic of opioid prescribing. No patients, pain management experts or practicing physicians were appointed, and the commission only heard testimony from addiction treatment advocates during its one public meeting.

That was better than the CDC, which held no public hearings while preparing the initial draft of its opioid prescribing guideline in 2015. As PNN has reported, the “Core Expert Group” and various stakeholders that advised the CDC were dominated by special interest groups and addiction treatment specialists, including five board members of Physicians for Responsible Opioid Prescribing (PROP), an anti-opioid activist group. Only after a public outcry and threats of a lawsuit did the agency delay the release of the guideline, seek public comment and form a new advisory panel.

Are you interested in becoming a member of the new task force on pain management or know someone who might?

Information on how to nominate individuals – including self-nominations -- can be found by clicking here. Applications are due by Wednesday, September 27. All nominations must be submitted via email to the attention of Vanila Singh, MD, Chief Medical Officer at PainTaskforce@hhs.gov.

Members of the task force who are not government employees will receive per diem pay and reimbursement for travel expenses. All task force meetings will be open to the public.

Canadian Opioid Guideline Modeled After CDC’s

By Pat Anson, Editor

Canada this week is officially adopting new guidelines for the prescribing of opioid pain medication that are very similar to those released by the U.S. Centers for Disease Control and Prevention a little over a year ago.

And, like the CDC guidelines, there is controversy over the role played by addiction treatment specialists and anti-opioid activists in drafting them.

The Canadian guideline, developed at the National Pain Centre at McMaster University and published in the Canadian Medical Association Journal, contains 10 recommendations for treating non-cancer chronic pain, most of them focused on reducing the use of opioid medication.

"Opioids are not first-line treatment for chronic non-cancer pain, and should only be considered after non-opioid therapy has been optimized," said Jason Busse, PhD, lead investigator for the guideline and an associate professor of anesthesia at McMaster University’s School of Medicine.  "There are important risks associated with opioids, such as unintentional overdose, and these risks increase with higher doses."

Nearly 1 in 5 Canadians suffer from chronic pain and Canada has the second highest rate of opioid prescribing in the world. 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.

The new guideline recommends that non-drug therapies, such as exercise and cognitive behavioral therapy, and non-opioid medications such as non-steroidal anti-inflammatory drugs (NSAIDs), be used first in treating patients with chronic pain. It is recommended that opioids only be prescribed if patients do not respond to non-opioid treatments, and only if they do not have a history of substance abuse or a psychiatric disorder.

The guidelines also suggest that initial doses of opioids be limited to no more than 50 mg morphine equivalents daily (MED), and strongly recommend that doses not exceed 90 mg MED. The previous Canadian guideline suggested a ceiling of 200 mg MED. For patients who already exceed 90 mg MED, the guideline recommends the gradual tapering of opioids to the lowest effective dose or to discontinue opioid treatment altogether.

"The opioid epidemic has serious consequences for families and communities across Canada. We are committed to working with our partners to ensure a comprehensive response to this public health crisis, including supporting physicians in improving prescribing practices. I applaud the work that went into updating the prescription opioid guideline, and I urge healthcare professionals to apply the recommendations when prescribing these types of medications," said Jane Philpott, Canada's Minister of Health, in a statement.

A major difference with the CDC guideline, which is intended only for primary care physicians, is that the Canadian version applies to all prescribers, including family physicians, pain specialists and nurse practitioners.

The Canadian guideline was also developed with more transparency than the CDC guideline, which was initially drafted in secret meetings by an unidentified panel of experts.  Leaks later revealed that the panel included several academics and addiction treatment specialists, but only one retired doctor with experience in pain management.

PROP Involved in Canadian Guideline

Four advisory panels involving 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.

Juurlink, an academic toxicologist at Sunnybrook Health Sciences Centre in Toronto, had an influential role on the Canadian Guideline Steering Committee; while Franklin and Sullivan, both of them Americans affiliated with the University of Washington, served on the Clinical Expert Committee.

Juurlink and Sullivan disclosed their involvement with PROP in their conflict of interest statements, while Franklin did not specifically name the group.

These guidelines, which appear to be influenced by the extremely flawed and biased guidelines by the CDC in the United States, written by a small group of anti-opiate crusaders with strong ties to a large drug rehab chain, seem to reflect more attention to people with addictions and not people with pain,” said Barry Ulmer, Executive Director of the Chronic Pain Association of Canada, in written comments to the guideline.

PROP's founder and Executive Director, Andrew Kolodny, MD, was until recently chief medical officer of Phoenix House, which runs a chain of addiction treatment facilities in the U.S.

A news release on the guideline produced by McMaster University emphasizes that experts with “diverse views on the role of opioids” participated in drafting them and only those “without important financial or intellectual conflicts of interest” were allowed to vote on the recommendations.

Ulmer says the guidelines should have focused on improving pain education for physicians, which is limited in medical schools in both Canada and the U.S.

“Pain patients feel strongly the authors and policy makers behind these guidelines have missed another golden opportunity to create real change in this area of medicine. They would have impacted pain medicine far more positively if they had used their resources to develop forward thinking educational programs and incorporate them into the curricula in our teaching hospitals,” Ulmer wrote.

“By putting forth guidelines like this, at this time, to influence (or control) a profession that has little education and understanding about chronic pain is myopic and similar to the last attempt at guidelines will simply encourage more physicians to dump pain patients they now have. Or is that the real goal?”

One of the many unintendend consequences of the CDC guidelines in the United States is that pain patients are losing access to treatment. A recent survey of over 3,100 patients by PNN and the International Pain Foundation found that over 60 percent had a hard time or were unable to find a doctor willing to treat their chronic pain. Over 90 percent believe the CDC guidelines have harmed patients and worsened the quality of pain care. 

Although the CDC guidelines are voluntary and only intended for primary care physicians, they are being implemented and treated as mandatory by many prescribers, insurers, and federal and state agencies. Critics worry the same thing could happen in Canada.

“No guideline can account for the unique features of patients and their clinical circumstances, and the new guideline is not meant to replace clinical judgment. Patients, prescribers and other stakeholders, including regulators and insurers, should not view its recommendations as absolute,” wrote Drs. Andrea Furlan of the Toronto Rehabilitation Institute, and Owen Williamson of Monash University in Australia, in an editorial published in the Canadian Medical Association Journal.

British Columbia adopted its own mandatory version of the CDC guidelines nearly a year ago, and made them a legally enforceable standard of care for all prescribers. The move has yet to slow the rising tide of drug overdoses in British Columbia, which are now occurring at a rate of four deaths every day. Most of the overdoses are blamed on illicit fentanyl and other street drugs, not prescription opioids.

Few Changes as CDC Releases Opioid Guidelines

By Pat Anson, Editor

After months of controversy, the Centers for Disease Control and Prevention (CDC) has released the final version of its opioid prescribing guidelines, which discourage primary care physicians from prescribing opioid medication for chronic pain. The dozen guidelines are largely unchanged from a draft version that was released last September.

You can see the guidelines yourself by clicking here.

“Management of chronic pain is an art and a science. The science of opioids for chronic pain is clear: for the vast majority of patients, the known, serious, and too-often-fatal risks far outweigh the unproven and transient benefits,” CDC director Thomas Frieden, MD, wrote in article published in the New England Journal of Medicine.

Although voluntary and intended only for primary care physicians, many experts believe the guidelines will quickly be adopted by other doctors who treat pain, as well as regulatory agencies, local governments,  and professional medical organizations. Many pain patients fear losing access to opioids as a result.

The guidelines state that “nonpharmacologic therapy and nonopioid pharmacologic therapy” are the preferred treatments for chronic pain, and that doctors should only consider opioids if the benefits in pain relief and function outweigh the risks of addiction and abuse. Even if opioids are prescribed, the CDC recommends that they be used in combination with other therapies.

The guidelines also recommend the use of immediate release opioids instead of extended release opioid medication and that doctors be cautious about prescribing doses higher than 50 morphine milligram equivalents (MME) per day. Doctors are strongly advised to avoid increasing doses over 90 MME per day.

For acute pain from injuries or medical procedures such as surgery, the CDC states that three days or less supply of opioids “often will be sufficient” and that 7 days supply “will rarely be needed.”

Doctors are also advised to consult prescription drug monitoring programs (PDMP) to determine if patients are abusing opioids or using dangerous combinations of medications. Urine drug testing is also recommended before starting opioid therapy and at least annually afterwards. The guidelines also discourage doctors from dropping patients if they fail to pass a drug test as that "could constitute patient abandonment and could have adverse consequences for patient safety."

The guidelines state that opioid pain medication and benzodiazepines should not be prescribed concurrently, and addiction treatment should be offered to patients who show signs of drug abuse.

The new CDC guideline emphasizes both patient care and safety. We developed the guideline using a rigorous process that included a systematic review of the scientific evidence and input from hundreds of leading experts and practitioners, other federal agencies, more than 150 professional and advocacy organizations, a wide range of key patient and provider groups, a federal advisory committee, peer reviewers, and more than 4000 public comments.” Frieden wrote, without mentioning that the CDC initially sought very little input from the public or healthcare providers.

The CDC's own experts also admitted much of the evidence to support the guidelines was weak. The agency planned to implement the guidelines in January, but was forced to delay them after widespread criticism about its secrecy and lack of transparency during the drafting of the guidelines.

In response to critics, a new advisory committee was formed to review the guidelines, but after a handful of private meetings the committee endorsed the guidelines with few changes.  A potential legal problem for the CDC is that none of its advisory committees' meetings were open to the public. The committees also reviewed the guidelines with outside consultants without publicly disclosing who they were.

Last year the Washington Legal Foundation (WLF) threatened to sue the agency for its “culture of secrecy” and “blatant violations” of the Federal Advisory Committee Act (FACA), which requires all such meetings to be open to the public.

"From the beginning we have been very disappointed in the manner CDC has conducted itself. We explained in detail last fall why we thought CDC had not acted in compliance with FACA. And while at first I was encouraged when CDC took steps to open up the process and perhaps try to compensate for some of its previous errors, I've seen nothing to suggest that it has really done so and in fact has just replaced one secret committee with another secret committee," said Richard Samp, WLF chief counsel. "I find it disappointing that a federal agency would not think it was incumbent to comply with federal law."

Samp told Pain News Network he was unsure if WLF would follow through on its threat to sue the agency and block the guidelines from being implemented.

"I can't say what if anything we plan to do from here or what anybody else plans to do," said Samp. "I just want to express our disappointment with the agency's procedural handling of this issue."

"We believe that this final version of the CDC guidelines leaves much to be desired," said Bob Twillman, PhD, Executive Director of the American Academy of Pain Management. "Looking across the two preliminary drafts and the final version, we see virtually no evidence that comments submitted by thousands of people with pain, patient advocacy organizations, and pain management societies resulted in any changes to the 12 recommendations in the guideline."

Twillman said he was concerned the "soft limits" on opioid dosages in the guidelines would be adopted as a rule by physicians, leaving some patients untreated or undertreated.

"Our concern is that, based on experience when states have implemented similar guidelines, some clinicians will interpret these 'soft limits' and thresholds as absolute ceiling doses, and that people with pain will suffer needlessly as a result," Twillman said.

"I don't see how they will contribute much to improved outcomes for people in pain," said Lynn Webster, MD, past president of the American Academy of Pain Medicine and Vice President of scientific affairs at PRA Health Sciences. " I wish the CDC would have advocated for the millions of Americans with chronic pain while also trying to curb the opioid crisis.  We will never solve the opioid problem if we don't do a better job of treating pain.

"The CDC should have called upon Congress to insist payers be part of the solution and not continue to be the major barrier to improved outcomes for people in pain and with opioid addiction."

Many of the non-opioid treatments and therapies the CDC recommends -- such as cognitive behavioral therapy, massage and physical therapy -- are not covered by insurers. 

"The CDC’s recommendations are very sound. They're pointing out that when opioids are used long term for chronic conditions they are more likely to harm patients than help. If you continue to take opioids daily for months and months, the opioids don’t work very well," said Andrew Kolodny, Executive Director and founder of Physicians for Responsible Opioid Prescribing (PROP), in an interview with KPCC Radio in Los Angeles.

PROP, which was heavily involved in the initial drafting of the guidelines, is funded by Phoenix House, a chain of addiction treatment centers that stand to benefit from the guidelines' recommendations.

"Opioids don't work well long-term. That's the CDC's message. That's what the evidence tells us. Its the industry and groups that get funding from industry that are promoting this inappropriate treatment," said Kolodny, who is chief medical officer of Phoenix House.

In a survey of over 2,000 pain patients by Pain News Network and the International Pain Foundation, many predicted the guidelines will lead to more opioid abuse and addiction, not less.  Nearly 93% said they would be harmful to pain patients. Most also said that non-opioid treatments and therapies provide very little pain relief or none at all.

Senator Alleges Conflict of Interest in Fed Pain Panel

By Pat Anson, Editor

An influential U.S. senator is raising questions about possible conflicts of interest on a federal panel that was highly critical of the CDC’s controversial opioid prescribing guidelines.

“I was alarmed to read of efforts by the members of the Interagency Pain Research Coordinating Committee (IPRCC) to weaken efforts underway at the Centers for Disease Control and Prevention (CDC) to develop guidance on opioid prescribing practices,” wrote Oregon Sen. Ron Wyden (D) in a letter sent to Health and Human Services Secretary Sylvia Burwell.

As Pain News Network has reported, several members of the IPRCC said the guidelines were “ridiculous” and “an embarrassment to the government” at a December meeting.

“Several non-Federal IPRCC members, their organizations, or both, appear to be recipients of funding from major pharmaceutical companies that manufacture opioids or related products at levels that raise serious concerns regarding the potential for conflicts of interest,” wrote Wyden. “These financial and professional relationships raise serious concerns about the objectivity of the panel’s members that deserve additional review.”

december, 2015 meeting of iprcc.

december, 2015 meeting of iprcc.

Wyden mentioned several of the panel members by name, including Myra Christopher and Dr. Richard Payne of the Center for Practical Bioethics, Penney Cowan of the American Chronic Pain Association and Cindy Steinberg of the U.S. Pain Foundation. All three non-profit organizations get a substantial portion of their funding from pharmaceutical companies, including Purdue Pharma, the manufacturer of OxyContin. Purdue gave over $100,000 to U.S. Pain Foundation in 2014, according to Wyden.

“I do not and have never been paid by a pharmaceutical company,” said Steinberg, who became a patient advocate after she suffered a serious back injury in an accident. Steinberg, who is National Policy Director for U.S. Pain Foundation, currently receives a small stipend of about $8,000 a year.

“I am fortunate in that my husband works to supports us.  I do this work despite my daily, debilitating chronic pain, often needing to lie flat in meetings to control the pain and lay across two plane seats to travel because I am passionate about improving pain care in this country,” Steinberg said in an email to Pain News Network.

“If anyone watches the video of the IPRCC meeting they will see that they had to bring in a special small sofa for me to lie on every hour so that I could participate. I am proud to do this work and am honored to represent the voice of millions of disempowered Americans who suffer from the pernicious disease of chronic pain and desperately need more and better treatment options."

Penney Cowan, another member of the federal panel mentioned by Wyden, also serves on the CDC “workgroup” that recently endorsed the agency’s recommended guidelines, which discourage primary care physicians from prescribing opioids for chronic pain.  

“When treating a person with pain, a health care provider needs to determine what is best for that individual based on physical examination, test results and what is important to the individual. The recommendations seem very clear on that point,” Cowan wrote in an email to PNN. “The American Chronic Pain Association advocates for a balanced approach to pain management - that means that all therapies such as PT (physical therapy), counseling, biofeedback and stress management, OT (occupational therapy), nutritional guidance and more should be available and used based on their appropriateness for each individual.”

Wyden’s letter does not mention that some IPRCC members who were most critical of the CDC guidelines are federal employees of the Food and Drug Administration and the Agency for Healthcare Research and Quality (AHRQ), who as government workers are not allowed to accept financial contributions.

The senator’s letter and an Associated Press story about it also fail to mention that the CDC itself has a foundation that accepts funding from healthcare companies such as Abbott Laboratories, Amgen, Medtronic, Johnson & Johnson, Merck, Quest Diagnostics and Pfizer,  companies which stand to benefit from the CDC guidelines because they offer non-opioid treatments or tests. The CDC Foundation accepted over $157 million from donors last year.  

Up to 11 million Americans use opioids daily to treat their chronic. A survey of over 2,000 pain patients by Pain News Network and the Power of Pain Foundation found that many fear losing access to opioid pain medication if the guidelines are adopted.

Committees Support CDC Opioid Guidelines

By Pat Anson, Editor

Two advisory committees expressed broad support Thursday for the controversial guidelines for opioid prescribing being developed by the Centers for Disease Control and Prevention (CDC). Those guidelines discourage primary care physicians from prescribing opioids for chronic non-cancer pain and recommend other therapies such as over-the-counter pain relievers, acupuncture, and cognitive behavioral therapy.

One newly formed committee --- which the CDC calls a “workgroup” --- did express “significant concern” about the cost of those alternative pain therapies and whether they are covered by insurance. The workgroup's report to the CDC’s Board of Scientific Counselors (BSC) also suggested that the guidelines be “framed with positive rather than negative language” that supports “integrated care for people with chronic pain.” It also recommends the impact of the guidelines be monitored for “unintended consequences” after they are implemented. 

The BSC voted to support the workgroup’s report, which can be found here.

“The BSC voted unanimously: to support the observations made by the BSC Opioid Guideline Workgroup; that CDC adopt the guideline recommendations that, according to the workgroup’s observations, had unanimous or majority support; and that CDC further consider the guideline recommendations for which the workgroup had mixed opinions,” said CDC spokesperson Courtney Leland in an email to Pain News Network.

“CDC is taking the BSC’s recommendations, as well as comments received from the public, into consideration in revising the guideline. The guideline is a priority for our agency. Given the lives lost and impacted every day, we have an acute sense of urgency to issue guidance quickly.”

The CDC planned to implement the guidelines this month with little public input, but was forced to change course after widespread criticism about its secrecy and lack of transparency during the drafting of the guidelines. In response to critics, the 10-member workgroup was formed three weeks ago and met four times by teleconference to review the guidelines. A potential legal problem for the CDC is that none of the workgroup’s meetings were open to the public. The workgroup also reviewed the guidelines with outside consultants without publicly disclosing who they were.

The Washington Legal Foundation (WLF) has threatened to sue the agency for its “culture of secrecy” and “blatant violations” of the Federal Advisory Committee Act (FACA), which requires meetings to be open to the public.

Over 4,300 online comments were received by CDC during a public comment period that ended earlier this month. Many opposed the guidelines as being too restrictive, while others wished the guidelines were stronger to combat the so-called epidemic of opioid abuse and overdoses.  There were passionate arguments on both sides, but in the end the workgroup decided that the case for the guidelines was stronger.

“Comments from patients and family members, in particular, expressed the desire that patient-centered care is enhanced rather reduced by these Guidelines. Members felt that the guidelines could be implemented in a manner consistent with patient centered care,” the workgroup said in its report.

As many as 11 million Americans use opioids for long-term chronic pain and many fear losing access to the drugs if the guidelines are adopted.

“The purpose of the guideline is to help to primary care providers offer safer, more effective care for patients with chronic pain and to help reduce opioid abuse disorder and overdose from these drugs,” said Debra Houry, MD, director of the CDC’s National Center for Injury Prevention and Control, which is overseeing development of the guidelines.

"The guideline itself is not a rule, regulation or law. It is not intended to deny access to opioid pain medication as an option in pain management. It is not intended to take away physician discretion and decision making.”

“Pain specialists and their patients fear the Guidelines will not be used that way though and adoption by boards, professional organizations, and insurers will pressure even specialty pain providers to taper patients,” said Anne Fuqua, a chronic pain sufferer and patient advocate. “Pain patients nationwide have been experiencing dose reductions and losing access to care altogether for several years, with the situation becoming more acute in the past year.  In an environment where physicians are tapering patient doses or ceasing opioid prescribing altogether, I feel these guidelines will serve like an accelerant in a growing fire.”

Although the CDC has said it doesn’t want the guidelines implemented until they are finalized, Fuqua said many doctors are already doing just that. She said her faith in democracy “took a swift kick in the teeth” as she listened to the workgroup’s presentation during a conference call. Fuqua was not given an opportunity to speak, although the president and founder of Physicians for Responsible Opioids Prescribing (PROP) were given time to address the BSC in support of the guidelines they helped draft.

“There were 28 comments supporting the Guidelines and 4 dissenters. One physician made statements partially supportive of our needs. CDC will no doubt use this ‘overwhelming support’ to justify adoption of the guidelines. I fear they see us as simply a casualty of war, much like those with tuberculosis who were quarantined to prevent disease spread. The only difference is that harming us doesn't save other lives,” she said.

CDC has not released a timetable on when it plans to finalize or implement the guidelines.

CDC Guideline: A Good Start that Needs Improvement

By Stefan Kertesz, MD, Guest Columnist

President Obama began his 2016 State of the Union address by referencing an American epidemic of opioid overdoses. He was right to do so. The Centers for Disease Control report that 2014 saw a record of 18,893 deaths related to opioid overdose, a category that includes both medications and heroin. Given a rising tide of deaths, it is only sensible to look closely at how opioids come into distribution. There is more than one path. Doctors write prescriptions, and the pills may be consumed properly or improperly. Or they can be sold, given to friends, or stolen. Heroin is incredibly cheap and potent these days. It’s often laced with other drugs and can cause overdose in ways that users can’t predict.

A major portion of the public health response has focused on doctors and their prescriptions (disclosure: I’m a primary care doctor trained in internal medicine and addictions). Most public health authorities believe a major contributor to the rising tide of overdoses has something to do with the prescriptions for opioids we write. Our tendency to write prescriptions for pills like hydrocodone or morphine rose precipitously from 2000 to 2011.

Everyone knows a story of someone who wheedles pills out of credulous physicians. Barring a few so-called pill mills (which alone cannot account for the rise in prescriptions), most doctors writing prescriptions for opioid pills do so in response to a patient with severe chronic pain. There are an estimated 100 million Americans with chronic pain, and between 5 and 8 million take opioids for that pain.

It stands to reason that among the patients who have received opioid prescriptions, surely some (or many) should not have received them. Many doctors have decided to prescribe less, starting in 2012, according to national data.

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If prescribing went down while overdoses went up these past few years, it’s fair to say that there is room for argument about precisely how doctor’s prescriptions relate to overdoses. But few would argue there is no relationship at all. Thus, great hopes are pinned on the notion that getting doctors to prescribe differently (and less) for their patients with pain will be key.

Last year the Centers for Disease Control, after consulting an extensive array of experts and interest groups, prepared a draft guideline for doctors on prescribing opioids. In December they placed notice in the Federal Register seeking public commentary. By deadline on January 13, over 4,300 comments were received.

There is a reason this document excites so much passion. In part, organizations such as the American Cancer Society project this guideline will not be voluntary, but will carry force of law.

The hope is to prevent development of addiction and overdose that devastates countless families. Yet, there are those 5 to 8 million patients who receive opioids, some of whom believe that they are at risk of losing access to a crucial medication that is helping manage their pain, improve their quality of life and overall function. As medical boards, insurers and government agencies enforce this guideline, prescribing differently from the topline recommendations is likely to become onerous, leaving many patients in the lurch.

If you listen to this conversation between this 70-year old coal miner who suffered 18 major injuries, and a chief advocate (addiction specialist Dr. Andrew Kolodny) for the reduction of opioid prescribing, you feel the tension. You will hear the distress of a man who fears being confined to bed from his pain, and the concern of an addiction doctor who believes opioid pills have done harm, not good, even perhaps to the man to whom he is speaking.

The experts convened by the CDC include many I know and respect. They have taken a fairly strong stand. They conclude that the literature shows no evidence of enduring benefit from opioids, and that measurable harms are tied closely to dose. They urge careful assessment of risk and benefit. They urge aggressive use of urine drug testing to identify patients who take opioid medication differently from intended or use illicit drugs.

In 56 pages, they say a lot more. My primary care patients include several with chronic pain, and my practice lines up pretty closely with precisely what the guideline recommends. And despite that, I feel this guideline is not yet ready, not given the power we project it to have.

For reasons I shared with the CDC, I think it reaches a bit beyond the available science in some places, neglects it in others, and misconstrues how best to translate it in the care of our patients. It risks making opioids less available to patients who are benefiting from them. It is not far from where it needs to be, but it needs improvement.

Friends, some of them national leaders in primary care, addiction and pain medicine, have urged me to publish this concern broadly.

For people interested in learning more about these concerns, I offer them in linked piece at Medium.com. I offer it to show that one can take a different stand without rejecting the science or the underlying public health commitment that I fully share with the honorable drafters of the CDC’s draft Guideline. For the readers who believe I am right, or perhaps have also misconstrued the science, I welcome your thoughts.

Stefan Kertesz, MD, is an Associate Professor at the University of Alabama at Birmingham School of Medicine. Opinions expressed are solely his own and do not represent positions of any agency of the U.S. Federal Government or the State of Alabama.

This column is republished with permission by the author. It originally appeared in Medium.com, along with the comments submitted by Dr. Kertesz to the CDC about the guideline.

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.