Still No Relief in Sight for Canadian Pain Patients

By Marvin Ross, Guest Columnist

Last month the U.S. Centers for Disease Control and Prevention said the agency’s 2016 opioid guideline does not endorse rapid tapering or discontinuation of opioid therapy. The CDC was responding to mounting criticism that its controversial guideline was causing harm to patients, including uncontrolled pain, depression and suicide.

As a Canadian, I am envious and embarrassed, for it is not over for pain patients in Canada. Americans have had active advocates in the American Medical Association and hundreds of doctors signing a public letter of protest, which resulted in the CDC and Food and Drug Administration finally admitting that forcing people to go off opiates is not good practice.

Canadian docs have said little about this, so I decided to ask the main authors of Canada’s opioid guideline, which is pretty much a copy of the CDC’s. They had written in response to me last year in the Canadian Medical Association Journal that they had “concerns” about inappropriate tapering and would “monitor the emerging literature.” Only one replied to me this time, saying that they speak out whenever they can, but no one will listen to them.

One anonymous doctor going by the name of “doc2help” objected to a piece I did in Medium suggesting that Canadian doctors have lost their moral compass. He thinks I am ill informed and doing damage.

I also let the office of the Canadian Minister of Health know what the CDC and FDA have done, as Health Canada has the same regulatory powers for drug approvals as the FDA. The answer was that they are having internal discussions.

Meetings and discussions make the bureaucracy go round-and-round. The Minister of Health did recently announce the formation of a chronic pain task force, but it has a three year time frame for more meetings.

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It is so much easier to blame patients and opioid prescribing, as Canadian authorities continue to do, even when most drug overdoses are the result of illicit fentanyl, not prescription opioids.

In Hamilton, Ontario, a medium sized city southwest of Toronto, opioid deaths are going up, while prescriptions are going down. Much of the illicit drugs in that city are due to pharmacy diversion, according to an excellent article in the Hamilton Spectator that revealed vast amounts of prescription drugs are making it onto our streets.

So far, 15 pharmacists have been caught peddling opioids illegally and Health Canada has found that over 1,400 Ontario pharmacies have reported missing drugs that they cannot account for. 

Dr. Anne Holbrook, director of clinical pharmacology at McMaster University, suggested it is patients who are selling their prescriptions on the street, but provided no studies to back up that claim when she spoke to the Spectator reporter. I have asked her directly and via the media relations department at McMaster University, but did not get a reply.  

Blaming patients is easy when you do not want to confront the fact that most street drugs are coming into the country illegally or being diverted by pharmacies.

A Toronto Star investigation found one Ottawa pharmacy that was responsible for putting at least 5,000 fentanyl patches on the street. The investigation found that between 2013 and 2017, nearly 3.5 million doses of prescription drugs disappeared from Ontario pharmacies. Over 200 Ontario pharmacists were disciplined by their professional body for diverting “massive amounts of deadly opioids.”

Our governments are ignoring all of this and blaming the poor chronic pain patients. Those of us in Canada will have to wait while the bureaucrats hold meetings and write papers before anything will be done.

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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.

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.

What Next for CDC Opioid Guideline?

By Pat Anson, PNN Editor

The pain community is reacting with a fair amount of skepticism to efforts by the CDC to address the widespread misuse of its 2016 opioid prescribing guideline.

A CDC commentary published Wednesday in The New England Journal of Medicine warns against the “misapplication” of the guideline, which has resulted in hard dosing limits, forced tapering and the medical abandonment of thousands of chronic pain patients.

Although the guideline strongly recommends that daily doses of opioids not exceed 90 MME (morphine milligram equivalent), the guideline’s three co-authors say their advice was misinterpreted and that the guideline “does not address or suggest discontinuation of opioids already prescribed at higher dosages.”

A CDC media statement this week also claimed “the guideline does not support abrupt tapering or sudden discontinuation of opioids.” 

That was surprising news to Rob Hale, a Missouri man with late-stage Ankylosing Spondylitis, a degenerative and incurable form of arthritis.  Like many other pain patients, Hale’s relatively high dose of opioid medication was significantly reduced soon after the guideline’s release.  As a result, he is now bedridden.

“This is amazing news, if they really intend to follow through with it,” said Hale in an email. “God, I hope this is the beginning of a turnaround in prescribing policies.  I just feel for the hundreds of us who gave up and took their lives or died as a result of the last 3 years of cruelty.”

Saving Face

Why the CDC is acting now is unclear. Reports of patient harm began circulating soon after the guideline’s release in March 2016, and have only accelerated as insurers, pharmacies, states and practitioners adopted the guideline as mandatory policy. In a recent PNN survey of nearly 6,000 patients, over 85 percent said the guideline has made their pain and quality of life worse. Nearly half say they have considered suicide.

“I regard this CDC statement to be an effort to save face and maintain political dominance on an issue into which CDC improperly inserted itself under the influence of Andrew Kolodny and PROP,” said patient advocate Richard “Red” Lawhern, referring to the founder of the anti-opioid activist group Physicians for Responsible Opioid Prescribing.

“The statement fails to engage with the underlying issues which render the Guidelines fatally flawed.  It fails to acknowledge the essential repudiation of the entire guideline concept by the American Medical Association, plus multiple prominent medical professionals.” 

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“The CDC guidelines have been as harmful as predicted, and the silence over 3 years has been criminal. The ‘Who me?’ response is just as evil as the ignorant abuse of power that led to the crisis in the first place,” said Mark Ibsen, MD, a Montana physician whose license was suspended by the state medical board for “overprescribing” opioids. A judge overturned the board’s ruling.  

“Those who give a weak ‘mea culpa’ for misinterpretation of the guidelines are, in short, lying. The deaths of thousands of abandoned pain patients, including 6 of mine who lost access (to opioids), are on their hands,” Ibsen said. 

PNN asked a CDC spokesperson if the agency had received new information about patients being harmed by the guideline and received a vague response.  

“We have heard concerns from partners and stakeholders about policies and practices that are inconsistent with the 2016 Guideline and sometimes go beyond its recommendations. The misapplication of the Guideline can risk patient health and safety,” Courtney Lenard said in an email. “CDC authored this commentary to outline examples of misapplication of the Guideline, and highlight advice from the Guideline that is sometimes overlooked but is critical to safe and effective implementation of the recommendations.” 

The response was also vague when we asked if CDC would be directly contacting insurers, pharmacies and states to warn them about misapplying the guideline.

“CDC has engaged payers, quality improvement organizations, state health departments, and federal partners to encourage implementation of recommendations consistent with the intent of the Guideline,” said Lenard, citing a mobile app and a pocket guide to opioid tapering as examples of CDC outreach.

The agency also sent out a Tweet.

Lenard gave no indication that a revision of the guideline was imminent. She said the CDC was working with the Association of Healthcare Research and Quality (AHRQ) to evaluate “new scientific evidence” about the benefits and harms of opioids.  

“Results of these reviews will help CDC decide whether evidence gaps have been addressed and whether the Guideline should be updated or expanded for chronic or acute pain prescribing,” Lenard wrote. 

Undoing the Damage

The American Medical Association – which took a stand against the “inappropriate use” of the guideline last year -- released a statement saying the CDC needed to work more closely with insurers.

“The guidelines have been misapplied so widely that it will be a challenge to undo the damage. The AMA is urging a detailed regulatory review of formulary and benefit design by payers and PBMs (pharmacy benefit managers),” said AMA President-elect Patrice Harris, MD.

“The CDC’s clarification underscores that patients with acute or chronic pain can benefit from taking prescription opioid analgesics at doses that may be greater than the guidelines or thresholds put forward by federal agencies, state governments, health insurance companies, pharmacy chains, pharmacy benefit managers and other advisory or regulatory bodies.”

Dr. Ibsen said the Drug Enforcement Administration was “the other elephant in the room” because it has weaponized the CDC guideline to demonize and prosecute doctors for prescribing high opioid doses. 

“Arresting and punishing doctors who treat the sickest pain patients. Civil asset forfeiture as used in dealing with criminal drug dealers. Equate physicians with a license to practice as equal to or below said criminal drug dealers,” said Ibsen, listing some of the tactics used by prosecutors.

“Charge physicians with one felony for every Rx they write, making absurdly dramatic charging documents and headlines against doctors who are left with no income or assets to defend themselves in a contaminated jury pool. Charge doctors with murder for prescribing medications to patients who fail to follow the directions.”

It’s not just the DEA. The National Association of Attorneys General recently declared that the dose and duration of opioid prescriptions should not be decided by doctors and that the CDC guideline should essentially be treated as law.

“As a matter of public safety, there is simply no justification to move away from the CDC Guideline to encourage more liberal use of an ineffective treatment,” warns a letter signed by 39 state and territory attorney generals. “As Attorneys General of states with high rates of prescription drug abuse among our youth, policy makers and prescribers must be encouraged to continue to pursue laws and practices that reduce the high volume of opioids in our communities.”

“The standard of care is now determined by prosecutors and juries,” says Ibsen.

CDC: Opioid Guideline Should Not Be Used to Taper Patients

By Pat Anson, PNN Editor

The Centers for Disease Control and Prevention has taken its first concrete step to address the widespread misuse and misapplication of its opioid prescribing guideline.

In a commentary published in The New England Journal of Medicine, the guideline’s authors say the agency does not support abrupt tapering or discontinuation of opioid medication, and that the guideline’s recommendation that daily doses be limited to no more than 90 MME (morphine milligram equivalent) should only be applied to patients who are starting opioid therapy.

“Unfortunately, some policies and practices purportedly derived from the guideline have in fact been inconsistent with, and often go beyond, its recommendations,” wrote Deborah Dowell, MD, Tamara Haegerich, PhD, and Roger Chou, MD. “A consensus panel has highlighted these inconsistencies, which include inflexible application of recommended dosage and duration thresholds and policies that encourage hard limits and abrupt tapering of drug dosages, resulting in sudden opioid discontinuation or dismissal of patients from a physician’s practice.”

The co-authors also noted that the guideline “does not address or suggest discontinuation of opioids already prescribed at higher dosages,” nor does it seek to deny opioids to patients with cancer, sickle cell disease or recovering from surgical procedures.

The CDC’s clarification was cheered by patient advocates, who have been calling on the agency to address the suicides, patient abandonment and other unintended consequences of the guideline for over three years.

“The statement from the CDC is a long-awaited, robust clarification that has come at a critical time. They clearly defined that its Guideline cannot and should not be invoked to justify the forced reduction or denial of opioid pain medication to patients who use opioids to manage their long-term pain,” said Andrea Anderson, a patient advocate with the Alliance for the Treatment of Intractable Pain (ATIP).

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The CDC’s controversial guideline was released in March 2016 as a voluntary set of recommendations meant to discourage primary care physicians from prescribing opioids for chronic non-cancer pain. But the guideline was quickly adopted by states, insurers, pharmacies, practitioners and even law enforcement agencies, who saw it as a mandatory policy that all physicians should follow to reduce rates of opioid addiction and overdose.

Reports soon began surfacing of patients being forcibly tapered off opioids or being abandoned by doctors who no longer wanted to treat them. Within months of the guideline’s release, CDC was warned by its own public relations consultants that “doctors are following these guidelines as strict law” and that some patients “are now left with little to no pain management.”

In PNN’s recent survey of nearly 6,000 patients, over 85 percent said the guideline has made their pain and quality of life worse. Nearly half say they have considered suicide because their pain is poorly treated. Many are hoarding opioids because they fear losing access to the drugs and some are turning to other substances – both legal and illegal – for pain relief.

‘Unintended Harms’

Not until this month did CDC acknowledge that its guideline was causing patient harm.

“CDC is working diligently to evaluate the impact of the Guideline and clarify its recommendations to help reduce unintended harms,” CDC Director Dr. Robert Redfield wrote in an April 10 letter to a group of healthcare professionals. who had asked the agency to make a “bold clarification” of the guideline.

Redfield’s letter was sent the day after the Food and Drug Administration warned doctors not to abruptly taper or discontinue opioids. The FDA said it had received reports of “serious harm” to patients, including withdrawal, uncontrolled pain, psychological distress and suicide.    

“The clarification is an essential beginning because it is the CDC guideline that has been used by law enforcement agencies to surveil doctors and by major insurers and pharmacies in ways that deny pain patients access to opioid analgesia,” said Kate Nicholoson, a civil rights attorney and pain patient.  

It is the CDC guideline that has been used by law enforcement agencies to surveil doctors and by major insurers and pharmacies in ways that deny pain patients access to opioid analgesia.
— Kate Nicholson, Civil Rights Attorney

“Given the harms suffered by pain patients, a muscular, public-facing clarification from the CDC was needed. We hope that this action and the warning the FDA issued last week against abrupt tapering of pain patients will mark a beginning in protecting the rights of patients who use opioid medication appropriately to manage pain.” 

But other patient advocates wonder why it took so long for the CDC to act.

“It's gratifying to see CDC admit that its guideline is being misinterpreted and misapplied, as many of us have been warning for some time,” said Bob Twillman, PhD, former Executive Director of the Association of Integrative Pain Management. “It's a bit puzzling to me why it has taken them three years to do so, when many of us, myself included, told them within days of the guideline's issuance that these things were going to happen.

“Unfortunately, we've spent the past three years watching three dozen states violate CDC's stated intent that the guideline not be legislated, not to mention the untold numbers of insurance companies, health care systems, private practices, and pharmacy chains that have created a whole population of opioid refugees by misusing the guideline. Serious harms, including patient deaths, have resulted, and there is virtually no evidence that the intended effect of reducing prescription opioid overdose deaths has occurred, while overall opioid overdose deaths continue to climb rapidly.”

The New England Journal of Medicine is a respected publication with a wide reach among healthcare professionals, but it is not clear what CDC will do to caution states, insurers, pharmacies and law enforcement agencies about their misuse of the guideline.

“Unless Congress and the Executive Branch tell the DEA (and by association, state drug enforcement authorities and prosecutors) to stand down from persecuting doctors, I don't see any useful impact for this statement at all,” Richard “Red” Lawhern, PhD, of ATIP wrote in an email. “Doctors will continue to leave pain management and to desert their patients until they can be assured they will not be sanctioned, so long as they act in good faith to treat pain and manage their patients.” 

In recent months, federal prosecutors in Wisconsin and several other states sent letters to hundreds of physicians warning them that their opioid prescribing practices exceed those recommended by the CDC. The doctors were identified through data-mining of prescription drug monitoring programs (PDMPs), which have been weaponized to target physicians. 

“Practitioners were identified where they prescribed on average 90 MMEs (or more) per patient per day. That’s the threshold where the CDC and the Wisconsin Medical Examining Board say there is no real evidence to suggest that above that amount has any better effect on chronic pain,” a DOJ spokesperson told PNN.  

Just last week, a DEA task force charged dozens of doctors and other healthcare providers with illegal opioid prescribing. Prosecutors say more criminal cases are in the pipeline. 

"We have hyper-accurate data at the DEA and other agencies in the federal government where we are able to (use) that data and we can sort of pinpoint where these pills are being over-prescribed just by the population center in which they're being prescribed," said Jay Town, a federal prosecutor in Alabama.  "There are more doctors out there, there are more people working in clinics, and physicians’ offices, or pharmacies, or in compounding pharmacies, that we still have ongoing investigations or beginning investigations.” 

‘Achieve Widespread Adoption’ 

The CDC may have finally acknowledged the “unintended harms” caused by the guideline, but the data-mining and wholesale adoption of its recommendations are exactly what the agency outlined in a 2015 CDC memo obtained by PNN:   

“Efforts are required to disseminate the guideline and achieve widespread adoption and implementation of the recommendations in clinical settings. CDC is dedicated to translating this guideline into user-friendly materials for distribution and use by health systems, medical professional societies, insurers, public health departments, health information technology developers, and providers, and engaging in dissemination efforts.  

Activities such as development of clinical decision support in electronic health records to assist providers’ treatment decisions at the point of care, identification of mechanisms that insurers and pharmacy benefit plan managers can use to promote safer prescribing within plans, and development of clinical quality improvement measures and initiatives to improve prescribing and patient care.”

Can the CDC undo all the harm its “user-friendly materials” have caused over the last three years? Will states be advised to rollback their laws and regulations? Will insurers and pharmacies be told to stop limiting the dose of opioid prescriptions? And what about the patients who committed suicide? The CDC did not respond to a request for comment.

“That no one at CDC anticipated that the guideline would be misinterpreted and misapplied in this way is hard to swallow,” said Twillman. “I would have hoped that they would be vigilant for such occurrences, and taken action swiftly and effectively when they became apparent.”

When Will Forced Tapering of Opioids End?

By Lynn Webster, MD, PNN Columnist

“Larry” recently wrote to me asking for advice. He describes himself as "virtually crippled totally" after having his opioid medication cutback.

"I am being forced tapered and the PA I now have will not budge one inch on the weaning, as he calls it. I hate him. I have never had a more callous doctor in my life," Larry wrote.

"What does one do in my situation? Blow my brains out? A[n] intentional overdose? I have two beautiful dogs that depend on me and a son who needs me. I have to stay here on planet Earth although I want out of here so bad I beg God to kill me every morning noon and night. It is my daily prayer."

Unfortunately, Larry is only one of many patients who are struggling to be heard by their providers. Physicians are under government pressure to adhere to the CDC’s 2016 opioid prescribing guideline.

Although the CDC designed its guideline as voluntary, government agencies interpreted it as a mandate instead. The Drug Enforcement Administration has pursued doctors who prescribe a level of opioids that exceeds the guideline's recommended daily limit of 90 MME (morphine milligram equivalent), even when no patients have been harmed.

According to Maia Szalavitz, writing for Tonic, Dr. Forest Tennant was one of the few physicians who still were willing to prescribe high-dose opioids for the sickest pain patients. The DEA raided his California office and home, allegedly because the agency had reason to believe some of his patients were selling their medication.

There simply was no evidence of that. But as a result of the raid, Dr. Tennant retired from clinical practice.

Szalavitz wrote that the raid "terrifies pain patients and their physicians, who fear that it could lead to de facto prohibition of opioid prescribing for chronic pain and even hamper end-of-life care."

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Dr. Mark Ibsen in Montana had his license suspended by the state medical board for allegedly overprescribing opioids. According to Dr. Ibsen, the DEA warned him "he was risking his livelihood and could end up in jail if he kept prescribing." A judge later overturned the board’s decision.

As Dr. James Patrick Murphy, a Kentucky-based pain and addiction specialist, told the Courier-Journal, "many well-intended doctors are unfairly arrested 'all the time' in the hunt for those who recklessly contribute to patients' addictions and fatal overdoses."

As of this writing, The American University Law Journal plans to publish an alarming article by Michael Barnes, JD, about the raids on America’s top physicians.

Although few physicians are incarcerated for prescribing high dosages of opioids, many of them are threatened with losing their licenses to practice medicine. Doctors and pharmacists told a POLITICO survey that they felt enormous pressure to limit their prescriptions for painkillers. Their fear of the consequences of noncompliance with the CDC guideline exceeded their responsibility to treat patients with severe pain.

Second Thoughts About CDC Guideline

On April 1, the attorneys general of 39 states and territories wrote a letter on behalf of the National Association of Attorneys General to Dr. Vanila Singh of the U.S. Department of Health and Human Services. The letter expressed concern with the draft report of the Pain Management Best Practices Inter-Agency Task Force, which recommends changes in the CDC guideline to end the forced tapering of patients.

The attorneys general said "it is incomprehensible that officials would consider moving away from key components of the CDC guideline." Additionally, they expressed their hope that the report would be revised "to clearly state that there is no completely safe opioid dose."

Yet on April 9, the Food and Drug Administration issued a medical alert warning doctors not to abruptly discontinue or rapidly taper patients on opioid medication, because it was causing “serious harm” to patients, including uncontrolled pain, psychological distress and suicides.

Now it seems the CDC may be moving in the same direction.

Dr. Daniel Alford, a Professor of Medicine at Boston University, wrote a letter to the CDC asking it to address the misapplication of its guideline with a "public clarification." He was writing on behalf of Health Professionals for Patients in Pain, and 300 healthcare professionals signed his letter.

The CDC's response, published on April 10, echoed the FDA's statement. CDC Director Dr. Robert Redfield observed that the CDC guideline "offered no support for mandatory opioid dose reductions in patients with long-term pain." He reinforced the fact that the guideline was voluntary and that doctors should use their knowledge of their patients to determine which dosages were appropriate for them.

Dr. Redfield wrote that “CDC is working diligently to evaluate the impact of the Guideline and clarify its recommendations to help reduce unintended harms." And he agreed that "patients suffering from chronic pain deserve safe and effective pain management."

STAT News points out that the overzealous enforcement of the CDC guideline was indeed causing patients harm. "Denying opioids to patients who have relied on them — sometimes for years — may cause some to turn to street drugs, thereby increasing their risk of overdose," STAT warned.

According to The Washington Post, "Many patients have claimed that long-term use of the drugs is all that stands between them and unrelenting pain, and that they can take the medication without becoming dependent or addicted."

The CDC and the FDA now admit the guideline has been misapplied and mainstream media outlets are beginning to pick up the story. The question is: Will the DEA stop pursuing doctors who treat pain patients with levels of opioids that exceed the guideline's recommendations?

For Larry and other pain patients who have been forcibly tapered, the answer may be a matter of life and death.

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Lynn R. Webster, MD, is a vice president of scientific affairs for PRA Health Sciences and consults with the pharmaceutical industry. He is a former president of the American Academy of Pain Medicine and the author of “The Painful Truth.”

You can find Lynn on Twitter: @LynnRWebsterMD. 

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.

CDC Director Says Agency Will ‘Clarify’ Opioid Guideline

By Pat Anson, PNN Editor

CDC Director Robert Redfield, MD, has for the first time suggested that his agency may be preparing to make changes to its controversial opioid prescribing guideline.

“CDC is working diligently to evaluate the impact of the Guideline and clarify its recommendations to help reduce unintended harms,” Redfield wrote in an April 10 letter to Health Professionals for Patients in Pain (HP3). 

Redfield was responding to a March 6 letter from HP3 signed by over 300 healthcare professionals urging the CDC to make a “bold clarification” of the voluntary guideline, which has been implemented as a mandatory policy by many insurers, pharmacies, states and practitioners. As a result, many chronic pain patients have been denied or forcibly tapered off opioid medication and become disabled or bedridden. Some have turned to alcohol and illegal drugs for pain relief.

The situation has become so dire, the Food and Drug Administration issued an unusual warning this week cautioning doctors not to abruptly discontinue or rapidly taper patients on opioid medication. The FDA said it had received reports of “serious harm” to patients, including withdrawal, uncontrolled pain, psychological distress and suicide.    

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“The Guideline does not endorse mandated or abrupt dose reduction or discontinuation, as these actions can result in patient harm,” Redfield said in his letter, which was released a day after the FDA warning. “The Guideline includes recommendations for clinicians to work with patients to taper or reduce dosage only when patient harm outweighs patient benefit of opioid therapy.”

Redfield has been CDC director for a little over a year. The letter is his most extensive public comment to date on the opioid guideline, which was only intended for primary care physicians treating chronic, non-cancer pain. Redfield emphasized that doctors and patients should collaborate on tapering plans, but only “if a patient would like to taper.”

“The Guideline also recommends that that the plan be based on the patient’s goals and concerns and that tapering be slow enough to minimize opioid withdrawal,” Redfield said.

“We are so grateful to the CDC for its essential clarification,” said Sally Satel, MD, of the American Enterprise Institute and Yale University, who helped draft the HP3 letter. “Now it’s time for the federal, state, and non-governmental institutions that have invoked the CDC’s authority to push some traumatic changes to care to reverse course.”

‘Closing the Barn Door’

But critics wonder why it took the CDC three years to acknowledge that the guideline has been widely implemented beyond its initial intent.

“I find it striking that, while CDC has made statements from time to time about their intent that the guideline not be turned into legislation and regulations, this is the boldest statement they've made yet, and it's coming only after more than 35 states have legislated some part of the guideline, not to mention actions by payers,” said Bob Twillman, PhD, former Executive Director of the Association of Integrative Pain Management.

“If they truly did not anticipate that this was going to happen, then they were incredibly naive, because many of us made public statements predicting these outcomes at the time the guideline was released. I know there are some patient advocates who hope this will lead to the unwinding of some of the legislation, but I think that's a very long-term project. In other words, it's a bit like closing the barn door after the horse has already escaped.”

When it released its opioid guideline in 2016, the CDC pledged to evaluate its intended and unintended consequences and said it would make changes to the recommendations if needed. Redfield’s letter contains a 3-page enclosure that summarizes the agency’s efforts to evaluate the impact of the guideline. A careful reading of the enclosure, however, shows that most of the studies underway are not being conducted by the CDC itself and that they focus primarily on whether the guideline has been successful in reducing opioid prescriptions — not whether patients are being harmed by it.

“Honestly, I don't think it's such a bad thing that CDC is supporting outside work to assess the impact of the guideline. Having independent researchers who may not be as likely to feel a need to defend the guideline can only be helpful,” said Twillman.

“I sense this is a political delaying action to avoid having to admit that CDC was fundamentally wrong,” said Richard “Red” Lawhern, PhD, Director of Research for the Alliance for the Treatment of Intractable Pain (ATIP). “The Director of CDC letter has doubled down on several ‘initiatives’ which appear to assume that the original assumptions and declarations of the guidelines were correct -- which they weren't, and for which there is abundant published proof that they weren't.”

Lawhern wrote an open letter to Redfield this week, calling for CDC guideline to be revoked, not just clarified, because many of its key assumptions about the addictive potential of prescription opioids are wrong.

In PNN’s recent survey of nearly 6,000 patients, over 85 percent said the guideline has made their pain and quality of life worse. Nearly half say they have considered suicide because their pain is poorly treated. Many patients are hoarding opioids because they fear losing access to them and some are turning to other substances – both legal and illegal – for pain relief.

CDC: Guideline ‘Not Intended to Deny Any Patients Opioid Therapy’

By Pat Anson, PNN Editor

A top official with the Centers for Disease Control and Prevention says the agency’s controversial opioid guideline was never intended to deny prescription opioids to chronic pain patients.

Deborah Dowell, MD, is one of the co-authors of the 2016 guideline and the chief medical officer for the CDC’s National Center for Injury Prevention and Control. In a February 28th letter made public this week, Dowell attempted to dispel the widespread belief that the guideline is a mandatory policy for all pain patients.  

“The Guideline is not intended to deny any patients who suffer with chronic pain from opioid therapy as an option for pain management. Rather, the Guideline is intended to ensure that clinicians and patients consider all safe and effective treatment options for payments,” Dowell wrote. “CDC encourages physicians to continue to use their clinical judgement and base treatment on what they know about their patients, including the use of opioids if determined to be the best course of treatment.”

Dowell’s letter was addressed to three medical associations – the American Society of Clinical Oncology (ASCO), American Society of Hematology (ASH) and the National Comprehensive Cancer Network – which were concerned that the CDC guideline was being misapplied by insurers to patients with cancer and sickle cell disease.

In February, the three groups sent a joint letter to Dowell asking the CDC to release an immediate clarification that the guideline was not intended for patients in active cancer treatment.

“Although the CDC guideline clearly states that the guideline is not intended to apply to this population, many payers are still inaccurately applying the CDC guidelines to patients in active (cancer) treatment,” the letter said.

Dowell responded a few days later with her own letter -- stating that the guideline was never intended to deny “any patients” opioid medication, but that alternate pain therapies should be considered.

Her letter also noted that two clinical practice guidelines for cancer pain (here and here) have been published or updated since the release of the CDC guideline.

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“This clarification from CDC is critically important because, while the agency’s guideline clearly states that it is not intended to apply to patients during active cancer and sickle cell disease treatment, many payers have been inappropriately using it to make opioid coverage determinations for those exact populations,” ASCO Chief Executive Officer Clifford Hudis, MD, said in a statement.

“People with sickle cell disease suffer from severe, chronic pain, which is debilitating on its own without the added burden of having to constantly appeal to the insurance companies every time a pain crisis hits and the initial request is denied,” said ASH President Roy Silverstein, MD. “We appreciate CDC’s acknowledgement that the challenges of managing severe and chronic pain in conditions such as sickle cell disease require special consideration, and we hope payers will take the CDC’s clarification into account to ensure that patients’ pain management needs are covered.”

The CDC guideline is voluntary and only intended for primary care physicians treating chronic non-cancer pain. But after its release in March 2016, the guideline quickly metastasized throughout the U.S. healthcare system and became a mandatory policy for many insurers, pharmacies, states and practitioners.

‘Even Cancer Patients Suffer’

Many cancer patients who responded to PNN’s recent survey on the CDC guideline said they were denied opioid medication or not given enough for pain control.

“I'm fighting cancer a second time and I'm not being properly medicated, can't find a pain management (doctor) that will take me on. I have days where I am suffering and have no quality of life!” one patient wrote. 

“I'm a brain cancer patient and the CDC guideline has scared every doctor and oncologist in Connecticut. Even cancer patients suffer and they don't care because that's the law,” another said. 

“I was told two weeks ago that I have lung cancer and still cannot get anything for pain,” wrote another patient. 

“I had to go a year without pain meds and I am a stage 4 head and neck cancer survivor. The sudden withdrawal almost killed me,” said one patient. “Thank God I found a pain management doctor that understands head and neck cancer and the devastating effects it leaves forever. But even he is limited.” 

“I went through 6 weeks of chemo and radiation. My treatment caused muscle and joint pain that on some nights and days are so bad I wish I would have never survived my cancer. They have me on gabapentin. It is okay but does not stop the pain,” wrote another cancer survivor.

None of this is news to the CDC. Within months of the guideline’s release, CDC was warned by its own public relations consultants that “some doctors are following these guidelines as strict law” and that some patients “are now left with little to no pain management.” In a joint letter to the CDC, hundreds of healthcare providers also warned the agency that within a year of the guideline’s release “there was evidence of widespread misapplication” of its recommendations.

But except for an occasional letter -- like the one from Dowell -- there has been no systematic, publicized effort by the CDC to remind insurers, pharmacies and providers that the guideline is voluntary and exempts cancer patients. The agency has also failed to keep its pledge to study the impact of the guideline on patients and to revise it in future updates.

An Open Letter to the CDC Center for Injury Prevention

By Richard “Red” Lawhern, Guest Columnist

Dear Dr. Robert Redfield and Dr. Debra Houry,

By its passive refusal to conduct a thorough review of the impact and outcomes of its 2016 opioid prescribing guideline, the CDC’s National Center for Injury Prevention and Control is actively causing harm to hundreds of thousands of pain patients.   

Deserted by their doctors in a hostile regulatory environment, many are going into the streets seeking pain relief.  Possibly hundreds may already be dead of illegal fentanyl poisoning or suicide.  Military veterans, in particular, face draconian restrictions on the availability of safe and effective opioid medication therapy.   

And all for no good reason!

I suggest with every intention of professional and personal courtesy, that government organizations can no longer stand aside from this centrally important issue.  Such a stance will make you and other federal agencies accessories to state-sanctioned torture and negligent homicide.  That is unacceptable.   

As a former military officer, I respect a well-tried motto that I urge each of our regulators to take on as their own:   

      Lead, follow, or get out of the way! 

It has become clear that the CDC guideline must be immediately withdrawn for a major rewrite.  In its present form, the guideline is unjustifiably biased against opioid pain relievers, factually incomplete, in error on basic science, and founded on untested assumptions that do not hold up under any degree of careful scrutiny.   

The guideline is directly responsible for a vast regulatory over-reach by DEA and state authorities that is driving doctors out of pain management and denying safe and effective pain treatment for hundreds of thousands of patients.  

The CDC guideline has been publicly repudiated by no less an authority than the American Medical Association. Over 300 medical professionals have called for a rewrite of the guideline from the ground up. And a recent draft report by a federal task force calls for a reorientation of the guideline towards individualized patient-centered care, not the one-size-fits-all approach of the CDC. 

Multiple published papers have conclusively invalidated the guideline’s contention that there is a maximum dose threshold of risk for opioid addiction and overdose.   

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Likewise, contrary to assertions in the guideline, there are presently no validated long-term studies to support the use of non-opioid analgesics and NSAIDs, or the off-label prescribing of anti-seizure and anti-depressant drugs to treat pain. No Phase II or Phase III trials have been published on "alternative" techniques such as acupuncture, massage or meditation.  And there are no trials which directly compare these techniques to opioid therapy under documented protocols.  Alternative treatments can at best be regarded as adjuncts to be added to analgesic or anti-inflammatory treatment.  

Published papers also demonstrate that criteria used by CDC and other federal agencies to identify risk of opioid abuse or overdose have very limited predictive accuracy. These faulty criteria are now being used by Prescription Drug Monitoring Programs (PDMP’s) to "flag" patients presumed to be at risk, who are in fact not at risk but are being denied pain treatment due to false alarms.  

Opioids, Overdoses and Demographics 

We can now take this narrative a step further.  I have compiled overdose data directly from the CDC Wonder database and from the Agency for Healthcare Research and Quality Data. This data focuses specifically on deaths directly attributable to opioid-related overdoses or suicide. The chart below shows rates of mortality by age group from 1999 to 2017.

GRAPHICS BY RED LAWHERN

GRAPHICS BY RED LAWHERN

Note that the highest rates of opioid-related mortality are among youth and young adults, while the lowest rates are among people over age 55.  Moreover, mortality in youth has skyrocketed by 1,800% over 17 years, while remaining relatively stable in people 55 and older.

The chart below documents the contrast in opioid prescribing by age group in 2016.  Unsurprisingly, older adults and seniors are much more likely to experience chronic pain and are prescribed opioids at a rate nearly double that of young adults. These two demographic trends contradict the idea that opioid overdoses are linked to prescribing.  They’re not and the evidence proves it. 

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An updated analysis report further summarizes major themes we found in the overdose data.  The report reveals that “over-prescribing” of medical opioids was never a significant driver in opioid overdoses. There is no cause-and-effect relationship between rates of opioid prescribing versus rates of opioid overdose. In fact, it can be argued that in states where prescribing rates are highest, the trend may be in the opposite direction. 

The downward sloping red line in the chart below is called a "regression" line.  This is the trend line for the overdose and prescribing data from all 50 states in 2016. If there were a connection between high rates of opioid prescribing and overdoses, we’d expect the regression line to be pointing upward, not downward.

Overdose mortality rates are actually lower in high-prescribing states! 

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One plausible explanation for the downward sloping line is that in states where prescribing has been more suppressed, patients are being driven into unsafe street markets or are committing suicide when overwhelmed by pain.   

These findings have previously been published in the blog of Dr. Lynn Webster, former President of the American Academy of Pain Medicine and author of "The Painful Truth." 

The implications of this analysis are glaring: the National Center for Injury Prevention and Control has created a fatally flawed guideline which actively increases injury rather than reducing it.   

Taken in sum, the evidence reveals that key assumptions on which the CDC guideline is based are simply and conclusively wrong.  Continued refusal to reevaluate the guideline is morally, ethically, medically and legally wrong. The 2016 CDC guideline on opioids must be retracted.  NOW! 

(Editor’s note: Dr. Redfield is CDC Director and Dr. Houry is Director of the CDC National Center for Injury Prevention and Control. A longer version of this open letter has been sent by email to other federal agencies and officials.)

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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 and Director of Research for The Alliance for the Treatment of Intractable Pain.

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.