Canada Seeks Feedback on Proposed Opioid and Cannabis Guidelines

By Pat Anson, PNN ditor

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

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

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

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

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

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

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

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

To take the opioid survey, click here.

Medical Cannabis Survey

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

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

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

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

To take the cannabis survey, click here.  

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

A Little Shop of Horrors: VA Opioid Guideline for Veterans

By Richard Lawhern, PNN Contributor

As a volunteer patient advocate and healthcare writer, I read a very large volume of scientific and policy literature. And as a 21-year military veteran myself, I am particularly interested in Veterans Administration policies for treatment of chronic pain. Thus I reviewed with interest the VA’s 2017 Clinical Practice Guideline for Opioid Therapy for Chronic Pain.  

I also checked with a medical professional who practices in the VA hospital system to verify that the “guidance” of this document is still in force. It is. 

In my view, the VA opioid guidance is a “little shop of horrors” guaranteed to drive patients into medical collapse, and in some cases suicide. These direct quotes from the VA guideline should illustrate my concerns:

• “Since [2010], there has been growing recognition of an epidemic of opioid misuse and opioid use disorder (OUD) in America, including among America’s Veterans…. At the same time, there is a mounting body of research detailing the lack of benefit and severe harms of [long-term opioid therapy].”

• “We recommend against initiation of long-term opioid therapy for chronic pain.”

• “We recommend alternatives to opioid therapy such as self-management strategies and other non-pharmacological treatments.”

• “If prescribing opioid therapy for patients with chronic pain, we recommend a short duration… Consideration of opioid therapy beyond 90 days requires re-evaluation and discussion with patient of risks and benefits.”

• “We recommend against long-term opioid therapy for pain in patients with untreated substance use disorder.”

• “If prescribing opioids, we recommend prescribing the lowest dose of opioids as indicated by patient-specific risks and benefits…. There is no absolutely safe dose of opioids.”   

• “As opioid dosage and risk increase, we recommend more frequent monitoring for adverse events including opioid use disorder and overdose… Risks for opioid use disorder start at any dose and increase in a dose dependent manner. Risks for overdose and death significantly increase at a range of 20-50 mg morphine equivalent daily dose.” 

My VA colleague, who asked not to be identified, offers the following observations concerning VA policies in treating pain. This is paraphrased to protect the physician from retaliation:   

“The VA simply does not allow me the flexibility I need to manage my patients’ pain. All that is said about honoring our veterans and all the expressions of pride in the level of care the VA provides veterans thus ring hollow. The VA exhibits far greater pride in the percent reduction in opioid prescriptions it has been able to achieve, even giving out awards to physicians who make particularly large contributions to this effort.”

Let’s also compare these highly restrictive policies with a June 2020 letter from the American Medical Association to the CDC’s Chief Medical Officer on the pending revision of the 2016 CDC guideline:

• “We can no longer afford to view increasing drug-related mortality through a prescription opioid-myopic lens.”

• “Some patients with acute or chronic pain can benefit from taking prescription opioid analgesics at doses that may be greater than guidelines or thresholds put forward by federal agencies.”

• “A CDC Guideline only focused on ‘opioid prescribing’ will perpetuate the fallacy that by restricting access to opioid analgesics, the nation’s overdose and death epidemic will end.”

• “The CDC Guideline has been misapplied as a hard policy threshold by states, health plans, pharmacy chains, and PBMs.”

• “It is clear that the CDC Guideline has harmed many patients — so much so that in 2019, the CDC authors and HHS issued long-overdue … clarifications that states should not use the CDC Guideline to implement an arbitrary threshold.”  

The AMA recommended that the CDC should advocate explicitly for the repeal of all federal and state legislation that places hard limits on opioid prescribing.  Another recommendation is that physicians should treat both chronic pain and opioid addiction among the few patients who deal with both issues.  Discharging these patients or forcibly tapering them should no longer be automatic.

AMA is also on public record with the position that so-called “high prescriber” letters issued by prosecutors and state Prescription Drug Monitoring Programs (PDMPs) constitute a witch hunt against physicians and their sickest patients, and is a violation of legal due process.  

Not addressed by either the AMA or the VA is the reality that there are presently no field-tested tools that reliably evaluate quantitative risk of opioid tolerance, dependence or addiction in individual patients. 

As Nora Volkow, MD, and Thomas McMillan, PhD, of the National Institutes of Health wrote in The New England Journal of Medicine:  

“Unlike tolerance and physical dependence, addiction is not a predictable result of opioid prescribing. Addiction occurs in only a small percentage of persons who are exposed to opioids — even among those with pre-existing vulnerabilities... Older medical texts and several versions of the Diagnostic and Statistical Manual of Mental Disorders (DSM) either overemphasized the role of tolerance and physical dependence in the definition of addiction or equated these processes (DSM-III and DSM-IV).

However, more recent studies have shown that the molecular mechanisms underlying addiction are distinct from those responsible for tolerance and physical dependence, in that they evolve much more slowly, last much longer, and disrupt multiple brain processes.”  

A further complicating factor for the VA is that we now know beyond any reasonable contradiction that their attempt to restrict opioid prescribing is unsupported by science. 

There is no relationship between rates of opioid prescribing versus rates of overdose-related mortality. The demographics simply don’t work:  Although they have the highest rate of opioid prescribing for pain, seniors over age 62 have the lowest rates of overdose-related mortality.  Youths under age 19 receive the fewest number of opioid prescriptions, but have three to six times higher overdose mortality relative to seniors.

It is arguable that the VA guideline is just as fatally flawed as the CDC guideline, and is responsible for significant numbers of patient medical collapses and suicides among veterans.  Both documents fail conclusively on grounds of both medical science and medical ethics and both should be withdrawn immediately.

Richard “Red” Lawhern, PhD, has for over 20 years volunteered as a patient advocate in online pain communities and a subject matter expert on public policy for medical opioids.  Red is co-founder of The Alliance for the Treatment of Intractable Pain.

CDC Is Prioritizing Politics Over Science

By Dr. Lynn Webster, PNN Columnist

For most of my career, I have revered the Centers for Disease Control and Prevention (CDC). I believed it had the best scientists in the world, and that we could and should believe everything they said.

Not anymore. Unfortunately, the CDC has devolved into a partisan mouthpiece for politicians and people with agendas not supported by science.

The Academy Award-winning documentary Under Our Skin first showed me how politics can influence decisions at the CDC. The film illustrates how chronic Lyme disease (CLD) can cause a great deal of suffering, including chronic pain and fatigue. But the medical community has been unwilling to respond appropriately because the government has determined that CLD is a "controversial" diagnosis.

As a result, patients with Lyme disease often go undiagnosed and untreated until their symptoms worsen. The ongoing "Lyme wars" make it difficult for them to get testing and treatment.

Contagion is a theatrical movie about a pandemic that shows the CDC making decisions based on the political aspirations of key CDC officers. But this fictional story about a pandemic and the power-seeking nature of CDC officials was unfortunately prescient.

CDC Has Done Better

We have seen the tremendous work the CDC can do worldwide. The Ebola virus was contained, and potentially millions of lives were saved, because of the stellar work of enormously talented and dedicated CDC scientists.

The CDC activated its Emergency Response Center to protect the United States and its territories from the threat of the Zika virus, which can cause birth defects and Guillain-Barré Syndrome. My childbearing-age daughter cancelled trips to areas that the CDC warned posed a high risk.

The agency conducted more than 160,000 Zika virus tests, created registries to track pregnant women who were known to be infected with the virus, and provided $251 million in grants to state and local health departments. Their ongoing efforts to minimize the damage from Zika demonstrates the exemplary work the CDC can perform.

CDC's Politicization Is Not Partisan

The politicizing of the CDC is nothing new. During the Obama administration, the CDC became a tool of anti-opioid zealots. Republican Rep. Harold (Hal) Rogers of Kentucky is a senior member of the House Appropriations Committee. You may have heard his name recently, because he helped determine the amount of the CDC's emergency funding for the coronavirus.  

President Obama joined Rogers at the National RX Drug Abuse and Heroin Summit in 2016 to support increased funding to address prescription drug abuse. That action ignored the larger problem of illicit drug abuse and the fact that the opioid crisis has been mischaracterized as a prescription drug problem.

CDC Harmed Millions With Its Opioid Guideline

When Physicians for Responsible Opioid Prescribing (PROP), an anti-opioid activist group, was unable to get what they demanded from the FDA through a citizen petition, they turned to the CDC, where they found political allies. This led to the now infamous CDC Guideline for Prescribing Opioids for Chronic Pain in 2016. 

The guideline has caused enormous harm to millions of Americans. Recently, the American Medical Association implored the CDC to significantly change the guideline "to protect patients with pain from the ongoing unintended consequences and misapplication of the guidance." Even the guideline’s authors have backpedaled, acknowledging it has been misapplied to withhold opioid medication from patients who need it.

Yet the harm continues. Alarmingly, the Department of Justice interprets the guideline as a mandate, warning and sometimes prosecuting doctors who do not follow its voluntary recommendations. Dozens of states have blindly adopted the guideline in a naïve attempt to address the rising number of drug overdose deaths, either not understanding or ignoring the fact that most overdoses are due to illicit, rather than prescription drugs. 

COVID-19 Flip Flops

Now we see the CDC yo-yoing with their recommendations regarding COVID-19. Initially, the CDC said that masks were not necessary, except for those who were sick or taking care of someone who was sick. Now they recommend that everyone wear a mask. The Trump administration wants to leave that decision up to individuals, so they have not issued a federal mask mandate. This is contrary to the advice of most experts.

The CDC has also stated that testing for COVID-19 is important. But when the administration apparently pressured the CDC to change their position and recommend that asymptomatic people who were exposed to the virus not get tested, they did so, allowing politics to trump (no pun intended) science. CDC Director Dr. Robert Redfeld has now reversed his position and said COVID-19 testing is important for those who have been exposed to the virus, even if they are asymptomatic.

I agree with Dr. Leana Wen, a well-recognized authority on public health, who wrote in The Washington Post that the CDC’s testing guidance was “nonsensical.”

"I worry that this CDC change is part of a larger pattern of diluting recommendations when the federal government can’t do its job properly," Wen wrote.

Perhaps we all should worry. Who and what are we to believe? I, for one, can no longer believe what the CDC says unless it is verified by non-partisan scientific bodies.

This is a sad time. Our health is being played with as if it were a game. I feel like a commoner in Game of Thrones, as the kings fight for power and ignore their people. We, the commoners, should insist that the CDC become an independent agency no longer headed by a political appointee, so it would be unassailable by politicians who are more interested in controlling messages than diseases. 

Lynn R. Webster, MD, is a vice president of scientific affairs for PRA Health Sciences and consults with the pharmaceutical industry. He is author of the award-winning book The Painful Truth, and co-producer of the documentary It Hurts Until You Die. Opinions expressed here are those of the author alone and do not reflect the views or policy of PRA Health Sciences. You can find him on Twitter: @LynnRWebsterMD.

AMA Opposed to ‘Blacklisting’ of Doctors Over Rx Opioids

By Pat Anson, PNN Editor

The American Medical Association is hardening its opposition to public and private policies that seek to limit opioid prescribing. The AMA House of Delegates this week passed resolutions calling for prescribing guidelines to be amended to allow physicians to use their own clinical judgement to decide if higher doses of opioids are medically necessary. The AMA’s ruling body also called for an end to the “blacklisting” of doctors who prescribe high doses.

The AMA didn’t always feel this way about guidelines. When the CDC released its controversial opioid guideline in 2016, the AMA sent a letter to CDC Director Thomas Frieden that “applauded the CDC for treating the epidemic of opioid overdose deaths as a high priority.” And Patrice Harris, MD, a psychiatrist who chaired an AMA Task Force to Reduce Opioid Abuse, said the AMA was “largely supportive of the guidelines.”

Harris, who recently became the AMA President, now says the guidelines “have no basis in science.”

“Physicians can’t be expected to fight the epidemic with one hand tied behind their back, handicapped by policies that limit choices for patients and have no basis in science,” Harris said in a statement.

The AMA House of Delegates finally took a stand against the CDC guideline last November, when it passed resolutions opposing the “misapplication” of the guideline by pharmacists, insurers, pharmacy benefit managers, states and regulatory agencies.  

Although the 2016 guideline is voluntary, it has resulted in many patients being forcibly tapered to lower doses, cutoff entirely or even abandoned by their doctors – all under the guise of preventing opioid addiction and overdoses.

This week’s resolutions by the AMA’s ruling body went a step further, calling for an end to the “inappropriate use” of the CDC guideline to set dosing limits and blacklist physicians who exceed them.  

RESOLVED that our AMA support balanced opioid sparing policies that are not based on hard thresholds, but on patient individuality, and help ensure safe prescribing practices, minimize workflow disruptions, and ensure patients have access to their medications in a timely manner, without additional, cumbersome documentation requirements.

RESOLVED that our AMA oppose the use of “high prescriber” lists used by national pharmacy chains, pharmacy benefit manager companies or health insurance companies when those lists do not provide due process and are used to blacklist physicians from writing prescriptions for controlled substances and preventing patients from having their prescriptions filled at their pharmacy of choice.

RESOLVED that our AMA incorporate into their advocacy that clinical practice guidelines specific to cancer treatment, palliative care, and end-of-life be utilized in lieu of CDC’s Guideline for Prescribing Opioids for Chronic Pain as per CDC’s clarifying recommendation.

The CDC’s so-called clarification came in a commentary published April 24 in The New England Journal of Medicine. Three authors of the guideline did not take any responsibility for the poor implementation of their recommendations, but acknowledged that “some policies and practices purportedly derived from the guideline have in fact been inconsistent with, and often go beyond, its recommendations.”

Nearly two months later, not a single word of the CDC guideline has been clarified or changed, and insurers, pharmacies and many states continue to enforce its voluntary recommendations as mandatory policy.

Doctors who prescribe high doses of controlled substances are also being blacklisted by the DEA and state medical boards, which routinely use prescription drug monitoring programs (PDMPs) to identify and target physicians who are considered “high prescribers.”

Federal prosecutors have also sent letters to hundreds of physicians warning them that their opioid prescribing practices could subject them to criminal prosecution — often without any evidence that their patients were harmed by the drugs.

Doctors Say Guidelines Exaggerate Effectiveness of Lyrica and Neurontin

By Pat Anson, PNN Editor

There is little evidence that gabapentin (Neurontin) and pregabalin (Lyrica) should be used off-label to treat pain and prescribing guidelines often exaggerate their effectiveness, according to a new clinical review in JAMA Internal Medicine.

Gabapentin and pregabalin belong to a class of nerve medication known as gabapentinoids. The drugs were originally developed to prevent seizures, but their use has tripled over the past 15 years as more doctors prescribed them for a variety of chronic pain conditions. It is a common practice for doctors to prescribe drugs “off label” for treatments that are not FDA-approved.

“Gabapentinoids have become frequent first-line alternatives in patients with chronic pain from whom opioids are being withheld or withdrawn, as well as in patients with acute pain who traditionally received short courses of low-dose opioid,” wrote Christopher Goodman, MD, and Allan Brett, MD, of the University of South Carolina School of Medicine.

“The evidence to support off-label gabapentinoid use for most painful clinical conditions is limited. For some conditions, no well-performed controlled trials exist.”

Gabapentin is only approved by the FDA to treat epilepsy and neuropathic pain caused by shingles, but it is prescribed off label to treat depression, ADHD, migraine, fibromyalgia and bipolar disorder.  Pregabalin is approved by the FDA to treat diabetic nerve pain, fibromyalgia, post-herpetic neuralgia caused by shingles and spinal cord injuries, but it is also widely prescribed off-label to treat other types of pain.

The drugs are sold by Pfizer under the brand names Lyrica and Neurontin. The company has paid nearly $1 billion in fines for misleading and improper marketing of the drugs for off-label use.

“Despite documentation that these drugs were promoted improperly for off-label treatment of pain, the recent rapid increase in prescribing of gabapentinoids suggests a persisting sense among clinicians that gabapentinoids are highly effective pain medications,” the doctors wrote.

“Guidelines and review articles have contributed to this perception by often uncritical extrapolation from FDA-approved indications to off-label use.”

Goodman and Brett say the wording in many medical guidelines “reinforces an inflated view of gabapentinoid effectiveness” by falsely claiming the drugs should be used to treat all types of nerve pain.

“Another example is the 2016 guideline on opioid prescribing from the U.S. Centers for Disease Control and Prevention, which states broadly that gabapentin and pregabalin are first-line drugs for neuropathic pain, without further detail or specification,” they wrote. “Even for treatment of diabetic neuropathy (for which pregabalin is FDA approved and gabapentin is off-label), guideline conclusions tend to exaggerate effectiveness.”

Many patients who take gabapetinoids have side-effects such as dizziness or drowsiness, and there are an increasing number of reports that the drugs are being abused and sold on the street.   

Goodman and Brett have sounded the alarm before about the drugs, warning in a 2017 commentary in the The New England Journal of Medicine that “gabapentinoids are being prescribed excessively.”

They say doctors should do a better job warning patients about the side effects of gabapentinoids and the drugs should be stopped if a patient reports little or no benefit.  They also think medical guidelines should be revised to stop the promotion of gabapentinoids for any pain labeled as neuropathic.

Guideline Paranoia

By Carol Levy, PNN Columnist

I recently posted an article to an online chronic pain support group about the CDC’s opioid prescribing guideline.

“For treating acute pain, the guideline recommends a quantity no greater than what is needed for the expected duration of pain severe enough to require opioids, specifying that three days or less will often be sufficient and more than seven days will rarely be needed,” the guideline states.

It makes sense to me. And I assumed that would be the response my post would get. The recommendation is only for treating acute pain and acute pain shouldn’t need chronic, long term opioid treatment.

Instead, the replies were quick, angry and knee jerk:

“How dare they decide what and how many we need? This will hurt chronic pain patients.”

“They always come after us. These may be for acute pain patients, but you just know more draconian guidelines are just around the corner for chronic pain patients.”

The CDC guideline does not say, “And no one, even if their acute pain continues longer than 3 or 7 days, will be able to get the pain meds they need.” But that was how it was interpreted.

And then the people replying went one step further: “Soon they will be writing guidelines that even those in chronic pain can only have opioids for a specified period of time and a specific dosage, and not one grain more or one day longer.”

I see this common response and reaction as a major issue. When any new guideline is proposed (and people forget these are guidelines, not absolutes), it is a major catastrophe: “They are coming after us.”

Too often we act in a way that appears akin to addictive behavior. We have to have our opioid medications. And any restriction, even when it is not related to chronic pain, is one restriction too many: “They are going to take away my drugs. Then what will I do?”

We seem to have lost the concept of consideration. No time is taken to think through the new suggestions. Instead it is an immediate jump to: “This will hurt me. I won't be able to get the meds I need.”

For many of us, opioid medication is all that is left or the only option. The idea that someone, especially the government, may rip them from us is truly terrifying.

But I wonder. Maybe if we did not take any and all new guidelines as a frontal attack on us, maybe we would not be seen and referenced so often as a major component and cause of the “opioid epidemic.”

Carol Jay Levy has lived with trigeminal neuralgia, a chronic facial pain disorder, for over 30 years. She is the author of “A Pained Life, A Chronic Pain Journey.”  Carol is the moderator of the Facebook support group “Women in Pain Awareness.” Her blog “The Pained Life” can be found here.

The information in this column should not be considered as professional medical advice, diagnosis or treatment. It is for informational purposes only and represent the author’s opinions alone. It does not inherently express or reflect the views, opinions and/or positions of Pain News Network.

Ignoring the Evidence in Canada

By Marvin Ross, Guest Columnist

For those of us north of the border who are defending against the assault on pain patients, it was very gratifying to see the American Medical Association come out against the “inappropriate use” of the CDC guideline on opioid prescribing.

Sadly, we cannot hope that the Canadian Medical Association (CMA) will do the same. The CMA embraced the Canadian guideline – which is modeled after the CDC’s -- and argued for better evidence on the safety and efficacy of prescription opioids.

Sadly, how Canadian officials evaluate evidence is suspect. Jason Busse, the chiropractor who chaired the Canadian guideline, contends that no randomized controlled trials (RCTs) have been done on opioids that follow patients for longer than six months. He tweeted that to me after I challenged him on the results of an analysis that concluded that “to dismiss trials as ‘inadequate’ if their observation period is a year or less is inconsistent with current regulatory standards.”

I pointed out that multiple published studies and over 1.6 million patients maintained on doses over 200mg MME (morphine milligram equivalent) disprove his claim opioids don’t work long term.

Busse’s reply was, “Yes - the CDC guideline excluded all trials of less than 1 year duration. The Canadian guideline did not. Nonetheless, there are no RCTs of opioids that follow pts. For more than 6 months.”

He did not reply to my comment that Prozac was approved for use based on trails of only 12 weeks duration and that many patients take anti-depressants for years. It has always seemed strange to me that McMaster University, which led the development of the Canadian guideline, is the home to evidence based medicine. One of the co-ordinators of the guideline is Dr. Gordon Guyatt, who is credited as the one who brought evidence based studies to the world.

The most flagrant avoidance of evidence is by Health Canada, which continues to insist that high rates of opioid prescribing is one of the main causes of the opioid crisis. Ann Marie Gaudon, a columnist for PNN, has been attempting to find out what evidence Health Canada has to make that claim.

Not only have they not responded to her query, but her call to their office at the end of October resulted in one of the most bizarre phone calls ever heard. Syndicated radio show host Roy Green devoted two episodes to what can only be described as a “Who's on First” discussion with a government official.

Health Canada now mandates that every prescription issued for an opioid carry a sticker and a leaflet warning of addiction risks. A total wasted effort. The evidence that prescriptions opioids are a significant part of the problem is lacking.

The Ontario Drug Policy Research Network just released a database that disproves claims that prescriptions are a major cause of opioid overdoses. It shows that opioid prescriptions in Ontario have been declining for years, as they have in the United States.  About two-thirds of the opioid prescriptions written in 2015 were for patients over the age of 45 and less than 2 percent were for fentanyl.

Contrast those stats to information put out by this same agency on opioid deaths. Accidental overdoses among those 15 to 44 accounted for nearly 60% of opioid deaths. And the most common opioid involved in overdoses was fentanyl – most of it illicit and obtained on the black market.

It would be very refreshing if governments and regulators in Canada actually looked at their own data before cracking down on prescriptions for legitimate pain sufferers. That may be too much to expect, but one can always hope.

Marvin Ross is a medical writer and publisher in Dundas, Ontario. He has been writing on chronic pain for the past year and is a regular contributor to the Huffington Post.

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.

FDA to Develop Acute Pain Guidelines

By Pat Anson, Editor

The head of the U.S. Food and Drug Administration is following up on a promise to develop new federal prescribing guidelines for treating short-term, acute pain. But don't expect an overhaul of the CDC's controversial opioid guideline.

FDA commissioner Scott Gottlieb, MD, announced today that his agency has awarded a contract  to the National Academies of Sciences, Engineering, and Medicine (NASEM) to help develop guidelines for prescribing opioids for acute pain that results from specific medical conditions or procedures, such as wisdom tooth removal or post-operative pain.  

The CDC guideline takes a one-size-fits-all approach to chronic pain -- pain that lasts longer than three months -- and doesn't distinguish between pain from fibromyalgia, arthritis, neuropathy or any other medical condition.  

"We’ve contracted with NASEM to conduct a consensus study and issue a report on its findings. This work will begin with an identification and prioritization of procedures and conditions associated with acute pain for which opioid analgesics are commonly prescribed and where evidence-based clinical practice guidelines would help inform prescribing practices," Gottlieb said in a statement.

"We acknowledge the work of our colleagues at the U.S. Centers for Disease Control and Prevention (CDC) who have taken an initial step in developing federal guidelines on pain management and the use of opioids which are based on expert opinion. Our work seeks to build on that work by generating evidence-based guidelines where needed. The guidelines we generate would be distinct from this corresponding effort by the CDC, in that our effort would be indication-specific." 

Importantly, Gottlieb says NASEM will hold a series of public meetings and workshops, and seek input from "a broad range of stakeholders" from different medical specialties. The CDC guideline was initially developed with no public hearings and with little input from pain management experts.

While Gottlieb clearly wants more transparency brought to the guideline development process, he also clings to the notion that opioid medication is overprescribed and is primarily responsible for the nation's opioid crisis.

"Many people who become addicted to opioids will first be exposed to these drugs through a lawfully prescribed medication. Unfortunately, the fact remains that there are still too many prescriptions being written for opioids," Gottlieb said.

"Our analyses suggest that the first prescription for many common, acute indications could typically be for many fewer pills – maybe just a day or two of medication rather than a 30-day supply, which is typically prescribed. In some cases, the excess pills that aren’t used by patients may end up being diverted to illicit markets or misused or abused by friends or family members. In other cases, patients who are prescribed more medication than necessary may find themselves at increased risks for misuse, abuse and addiction."

But studies show that long-term opioid use by patients recovering from surgery is rare and less than one percent of legally prescribed opioids are diverted.

In 2016, the American Pain Society released guidelines that encourage physicians to limit the use of opioids and offer “multimodal therapies” to patients suffering from postoperative pain. Among the treatments suggested are pregabalin, gabapentin, NSAIDs and acetaminophen.

The University of Michigan has also developed prescribing guidelines for over a dozen common surgeries, ranging from hernia repair to hysterectomies. The recommendations list the suggested dose of opioids and number of pills for each procedure.      

Several states have already adopted their own guidelines for acute pain, limiting opioids to a few days' supply -- regardless of whether the pain is from a broken leg, a tonsillectomy or gunshot wound.  It's not clear how federal guidelines for acute pain would impact state regulations.

Message to CDC: Tear Down Your Walls of Silence!

By Richard Lawhern, PhD, Guest Columnist

In March 2016, the Centers for Disease Control and Prevention published its guideline for primary care physicians on prescribing opioid medication for chronic non-cancer pain.

Three months before its publication, Congress and President Obama made the guideline mandatory for the Veterans Health Administration, leading to revised practice standards at the VA that sharply restrict opioid medication for all veterans, regardless of risk or benefit. These unjustified restrictions were again written into federal law by the Veterans Administration Mission Act and recently signed into law by President Trump.

In civilian practice -- and despite being phrased as voluntary and only for general practitioners -- the CDC guideline was immediately and widely interpreted as a mandatory standard of practice for all doctors. 

Many insurers and healthcare providers adopted the CDC’s 90mg morphine equivalent dose (MME) as the maximum safe level of treatment, and some states have limited opioids to 7 days' supply or less for initial prescriptions, even after major surgery. 

More recently, Oregon’s Medicaid program has proposed rule changes that would forcibly taper many chronic pain patients currently on opioid therapy to zero. 

Major changes are also coming next year for Medicare patients nationwide that will sharply restrict high-dose opioid therapy for hundreds of thousands of older and disabled patients, by allowing insurers to require prior authorization for prescriptions in excess of 200 MMEs.

Almost immediately -- and despite wording in the CDC guideline discouraging such action -- doctors began coercing patients to eliminate or reduce opioids that were effective in managing their pain for years. State and federal law enforcement agencies like the Drug Enforcement Administration also ramped up the investigation and prosecution of doctors who prescribe high doses. 

Fearing loss of their livelihoods, many doctors refused to prescribe opioids or discharged patients who asked for them.  Some physicians left pain practice altogether.  As a result, tens of thousands of patients can no longer find effective pain treatment. There are widespread stories in social media, acknowledged in professional medical literature, of patients deserted by doctors who spiral down into agony, disability, and in some cases suicide. 

Where is CDC’s Guideline Evaluation?

One would think that federal agencies that caused such a public health disaster would be concerned with correcting course.  But that is not the case. 

Practice standards published by medical associations usually include a follow-up program to measure their safety and effectiveness. However, CDC has failed to conduct a full assessment of the opioid guideline in the nearly two and a half years since its release – even though the agency pledged in the guideline to conduct one:

“CDC is committed to evaluating the guideline to identify the impact of the recommendations on clinician and patient outcomes, both intended and unintended, and revising the recommendations in future updates when warranted.”

It is obvious why the CDC has maintained a wall of silence in the face of widespread criticism of the guideline by both patients and doctors. The agency is desperately wrong on three central assumptions about the opioid crisis:

1. The crisis was caused by “over-prescribing” medical opioids to patients in pain. Doctors were careless, greedy or deceived by evil pharmaceutical companies into ignoring risks of drug addiction.
2. There is no evidence that opioid analgesics are effective for pain when used over long periods.
3. Alternative pain therapies and non-opioid medications are safer and more effective than opioids and should be preferred over them.

All three of these assumptions are wrong.  Patient experience and published data from healthcare researchers demonstrate they are wrong. Let’s look at these three false assumptions.

Do Opioid Prescriptions Cause Overdose Deaths? 

Very rarely.  If prescribing increases the risk of opioid overdose deaths, then we would expect to see more overdoses in states and patient demographic groups where prescribing rates are highest.  But we do not. 

The following graphic compares overdose mortality rates from legal and illegal opioids to rates of opioid prescribing in all 50 states and Washington, DC in 2016.

SOURCE: CDC DATABASE

It might be difficult for a layman to make much sense of this graphic.  And that is precisely the point.  If there was a clear cause and effect relationship between prescribing and overdose deaths, then we would see higher death rates on the right side of the chart, with most data clumped closely around a rising central trend line.  But we don’t see that. 

The contribution of medically prescribed opioids to overdose deaths is so small that it gets lost in the noise of illegal street drugs.  Contrary to the screaming headlines in the media, prescription drugs aren’t killing people in large numbers. Illegal street drugs are.

This is not to say prescription drugs played no role in worsening the opioid crisis.  But in recent years, their role in opioid mortality has become small.  Even when they are found in the bloodstream of an overdose victim, opioid prescriptions are almost never found alone.  In Massachusetts, illicit fentanyl was found last year in 85% of blood toxicology screens of overdose victims, while heroin and/or cocaine were detected in about 45% of them.  Prescription opioids were found in only 15% of overdose victims.

Those numbers obviously don’t add up to 100 percent.  That is because the great majority of overdose victims had taken more than one illegal drug plus alcohol and/or benzodiazepine drugs.  We don’t really know which drug or combination of drugs caused the overdose.   

Overdose data also suggest that death is not a predictable outcome of opioid prescribing, nor is it common in groups that use the most opioid prescriptions. 

Basic trends in the chart below stand out.  First, rates of overdose deaths among people over age 50 have been stable for the last 17 years, while death rates among young people have risen sharply. In 2016, they were six times higher than in seniors.

We know that rates of opioid prescribing for seniors are at least 250% higher than for kids under 21. Thus, the group that benefited the most from liberalized prescribing policies of a decade ago – older adults -- has shown no higher risk of overdose deaths, even as kids who receive fewer opioid prescriptions are now dying in record numbers.

The asserted demographics of “over-prescribing” are plainly wrong. They don’t work and never have.  Exposure to medically managed opioids does not cause increased opioid mortality, at least not directly. 

Brief exposure to prescription opioids contributes very little to addiction or long term use. In two recent large-scale studies, opioid abuse and prolonged prescribing of opioids were evaluated for over 650,000 patients given opioids for the first time to control pain after surgery.  Fewer than 0.6% of these patients were diagnosed with opioid abuse 2.5 years later. 

This means that opioid treatment for acute pain is safe, effective and usually free of bad outcomes for over 99% of opioid-naive post-surgical patients.

Do Opioid Medications Relieve Chronic Pain?

Of course they do!

We hear a lot of noise that there is no evidence or proof that opioids work for long periods.  But “no proof” is not the same as “proof of no effect”. 

There are very few double blind clinical trials for opioids longer than 90 days -- and this reality is entirely understandable.  When people with severe pain are given placebos, they lapse into agony and drop out of trials.  Long term studies of any pain treatment can easily rise to the level of being inhumane – which is why so few have been conducted.

It isn’t rocket science, and the writers of the CDC guideline knew it.  Instead of comparing shorter trials of opioid analgesics against behavioral therapies and non-opioid medications, the guideline writers stacked the deck against opioids.  And they got caught at it by their medical peers. 

If trials of all three therapies had been limited to studies of at least a year -- as opioids were but alternative therapies were not -- none of the three could have provided “evidence” of useful effect.

We must also acknowledge that not all patients do well on opioids.  Some develop persistent nausea, sedation, constipation, suppression of sexual libido and depression. Some patients also become drug tolerant, requiring ever-increasing doses of opioids to achieve the same pain-relieving effects.  It has been theorized that a condition called “opioid induced hyperalgesia” may alter the action of opioid receptors in the brain.  But there is no medical consensus on how to measure such an effect in human beings, or even whether hyperalgesia exists. 

Many of the perceived failures of opioid therapy might be laid at the feet of ill-trained physicians.  Some doctors titrate their patients from zero to a therapeutic dose too fast.  Others fail to recognize factors in liver metabolism which make some patients poor metabolizers or hyper-metabolizers of opioids. Variation in metabolism means that there can be no one-size-fits-all pain treatment. Opioid therapy can be safe and effective for a small minority of patients at doses well above 1,000 MME.

Are Safe Substitutes for Opioids Widely Available?

For millions of patients, not yet.

We hear a lot of noise about tapering pain patients out of opioid therapy and into “alternative” or “integrative medicine.”  Indeed, it seems appropriate to first try less powerful medications such as NSAIDs or anticonvulsants before proceeding to opioids.  Exercise and massage therapy are also useful as palliative therapies.  But for millions of people, less powerful medications don’t work well enough -- or at all.  Tylenol or ibuprofen at high doses might also put you in a hospital with liver toxicity or major gastrointestinal problems.

What about “non-pharmacological” and “non-invasive” therapies?  Do they work well enough to be substituted for opioids?  Unfortunately, the answer is no. The state of science for alternatives like cognitive behavioral therapy, acupuncture, chiropractic, or various talk therapies is simply abysmal. 

At most, these alternative treatments are experimental.  They might be useful as supportive therapies in coordination with a well managed program of pain relieving medications.  But pending a more rigorous evaluation, we simply cannot offer such experimental techniques as substitutes for opioids. 

What Are Federal Agencies Doing to Correct Course?

In two words, “nothing apparent.”

The CDC, Food and Drug Administration, Health and Human Services (HHS), and the National Institutes of Health seem to be collectively dragging their feet in a campaign of deliberate inaction, refusing to respond to criticism or examine their own medical evidence of error.

This author and others have been trying for years to get healthcare agencies to reevaluate the relationship between opioid prescribing and overdose mortality. These efforts have included recent testimony to the FDA Opioid Policy Steering Committee and to the HHS Inter Agency Task Force on Best Practice in Pain Management.

In addition, copies of our analysis have been sent to the following authorities.  Most have been silent and none have responded in substance.

• Dr. Scott Gottlieb, FDA Commissioner and senior analytics staff
• Dr. Sharon Hertz, Director, Division of Anesthesia, Analgesia, and Addiction Products, FDA
• Dr. Mary Kremzner, Director, Division of Drug Information, FDA. (Dr. Kremzner responded with a courteous letter referring to a press release from Scott Gottlieb). 
• Alicia Richmond Scott, Designated Federal Officer, and Dr. Vanilla Singh, Chair of the HHS Inter Agency Task Force on Best Practices in Pain Management  
• Dr. Nora Volkow, Director of the National Institute on Drug Abuse
• The Whistleblower gateway of the House Subcommittee on Government Oversight

An inquiry was also filed online with the CDC. A dismissive response was received from the CDC Center for Injury Prevention – which oversaw development of the opioid guideline -- claiming to have read my analysis and asserting their previous positions.  This response was clearly a brush-off adapted from previous form letters.

A request is now in preparation to the HHS Office of the Inspector General, asking for investigation of CDC for malfeasance and possible fraud.

Richard Lawhern, PhD, has for 21 years volunteered as a patient advocate in online pain communities and a subject matter expert on public policy for medical opioids.  He is co-founder and corresponding secretary of the Alliance for the Treatment of Intractable Pain.

Graphics in this article originally published by The Crime Report on January 21, 2018, in "The Phony War Against Opioids - Some Inconvenient Truths."

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.

When Will They Start Listening to Pain Patients?

By Ann Marie Gaudon, PNN Columnist

It’s often suggested that pain patients and their advocates write or call elected officials, government regulators and physicians’ organizations to protest the sorry state of pain care in the U.S. and Canada. Many of us do just that and wind up feeling ignored or dismissed.

I have now corresponded with two different physicians at the College of Physicians and Surgeons of Ontario (CPSO), only to be passed onto their “Director of Strategy” (a fancy pants title no less).

The CPSO is the body which governs physicians in Ontario and it has rigidly enforced Canada’s 2017 guideline for opioids. They have monitored patient files, hauled over 80 doctors in to investigate “overprescribing” and basically terrorized doctors for prescribing opioids.

The doctors in turn deny and restrict opioid medications to their patients out of fear for losing their licenses.

I have asked the CPSO these questions:

• What evidence do you have to indicate the long-term use of opioids increases pain?
• Why is the chronic pain population being penalized for overdose deaths due to illicit street drugs?
• Why are you not listening to chronic pain researchers, physicians and patients?
• Does a decrease in opioid prescriptions and an increase in overdose deaths suggest a statistically significant relationship?
• How is it ever acceptable for pain patients to be dictated to by non-pain specialists?

I have provided no less than 27 references to show that there was never a connection between chronic pain patients and those dying from overdoses. However, no one has provided me with answers to my questions -- not even fancy pants.  In fact, the CPSO continues to disseminate disingenuous information about pain management, opioids, addiction and overdoses.

And remember folks, these are the people who took an oath to care for the suffering. That would include all of us pain patients -- or one would think. To put out genuine effort and have nothing but deaf ears returned is sickening -- pun intended.

Health Canada also hasn’t answered my questions and continues to make baseless claims such as "high rates of opioid prescriptions are a contributing factor to Canada's opioid crisis." Predictably, when the media hears that, they rush to publish the news that Health Canada plans to “severely restrict marketing of opioids” -- as if that will have any effect on those dying from overdoses. It will not. The non-pained public laps it up.

I also wrote to my representatives in Parliament. MPP Michael Harris did not respond in any way. MP Marwan Tabbara responded with a boilerplate letter about the opioid crisis, yet when I asked for a purposeful response, none was forthcoming.

Dr. Helena Jaczek, Ontario’s Minister of Health, did not address my concerns either. A representative of Health Quality Ontario did respond to me quickly, yet when I replied with additional concerns, I had no further correspondence.

I’m aware that our friends in the U.S. are certainly not being heard either. Scores of you sent letters and emails commenting on the open letter that desperate pain sufferer Charles Malinowski sent to California Sen. Kamala Harris, who replied with a boilerplate letter filled with hype and hysteria about opioids and how more funding was needed to treat addiction.

Another example is when over 100 comments were submitted to the DEA asking it not to cut the supply of opioid medication because it could lead to shortages and worsen the quality of pain care. The DEA’s response? The agency said the comments dealt with medical issues that were “outside of the scope” of its order. Then it cut the supply anyway.

A genuine letter is sent and verbal diarrhea is returned. I can assure you that this phenomenon is not just “Made in America.” 

If you’ve written or tried to be heard and have gotten nowhere, that is no reason to stop trying to hold governments and physician groups accountable for their shameful disregard for pain patients. We have just had a shakeup in Ontario’s government, so it's all new players now. Will they help? I intend to find out.

Who is with me? More than ever pain patients and advocates need to stick together, focus and move toward effective change. Don’t make quitting an option. If you live in Canada and are a pain patient having unethical treatment forced upon you, please join us at this Facebook page. 

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.