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).

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.”

What It’s Like to Be Forcibly Tapered Off Fentanyl

By Emily Ullrich, Guest Columnist

Although I have been on this chronic intractable pain, illness and medical refugee train for nearly a decade, I’ve been lucky to have the love and support my husband, family and wonderful people around the world that I've met through this shared anguish. They lift me up and allow me to lift them, when I can.

Right now, I'm holding onto them in utter panic, because they’re all that I have left.

About four years ago, I met a palliative care doctor, who had taken the time to read my 3-page health history. I take that paperwork with me to every visit to the ER or new doctor, so they can fully understand the things that I have tried, what worked, and what made things worse. No doctor had ever looked at it, until she did.

She approached me with zero judgment, and 100% sympathy and empathy. She actually cared about what I'd been through. I broke down sobbing, because I could finally let my guard down. I told her how my husband had to take a day off from work every month to drive me five hours and three states away, to see the only doctor I could find who was willing to treat my complicated needs. She told me I could see her instead. That was a tremendous gift.

Last year I began to sense that there was growing pressure on her about prescribing high doses of opioids, so I asked if I should worry about her cutting my meds or passing me off to another doctor. She reassured me that she would do no such thing.

Then came my visit one month later. I knew something was awry, because there was a case worker present for my appointment. My suspicions were confirmed when I was told the dose of my fentanyl patch would be tapered significantly lower. I was thrown into a tailspin.

With my doctor’s help and willingness to prescribe the meds and dosages that I needed, I had been able to achieve about a 4/10 on the pain scale, daily. I was able to participate in life again and do things that I love, like cooking, getting dressed up to go on a date with my husband, and other things that healthy people take for granted.

I was furious and traumatized that I was going to have to give up living my life. I still am.

On my next visit to see my doctor, she dropped another bomb. She told me that I had to choose between anti-anxiety meds and pain meds. Ironically, she was the one who put me on a higher dose of Xanax to help me cope with anxiety and insomnia. I felt betrayed.

I would not wish the hell of abruptly and simultaneously tapering off fentanyl and Xanax on anyone.  Even when I had a higher dosage, I still had pain flares that were not properly controlled. But since the taper began, I now have them daily.

I want this to be very clear: Fentanyl is a necessary medicine for many people with high pain levels. I have tried every other extended release medication known and none even touched my pain.

Fentanyl has gotten a bad reputation and patients who take it live with heavy stigma because the media usually report on fentanyl overdoses without distinguishing between illicit fentanyl and properly prescribed legal fentanyl.  

I would like to make a plea to the media: Stop the ignorant reporting and do your due diligence. By not distinguishing between legal and illicit fentanyl, you are causing even more strife for those of us who need the relief that only fentanyl medication brings.

I have still not gotten a clear reason for my doctor's decision to force a taper on me. I fear if I prod too much, she will totally cut me off or advise me to see someone else. This is making the struggle even worse, because even though we still have a pleasant relationship, I'm hurt and confused about this. I suspect it is being forced upon her.

As I wrote this, I had to take breaks for hours, sometimes days, because my pain is escalating to such a level that anxiety and insomnia are ravaging my mind and body. I have been in withdrawal (which, by the way, does not mean I am addicted to my medication, it means I'm physically dependent on it) for about four months.

As my medicine has been tapered, my life has crumbled. I get about two hours of sleep every five days. At times I get uncontrollable head shaking, leg kicking, arm flailing and vocal ticks. My pain gets so bad that I develop a full-body rash and migraines that last for days.

I don't know what is real and what my brain has concocted. I hold nonsensical conversations, like my grandparents did when they developed dementia. It is embarrassing and terrifying.

One night, while counting down the minutes until I could take my next dose of meds, I passed out from pain and anxiety, which scared my husband so bad that he called 911.

I hope that insurers, pharmacies and especially government officials who are infringing on doctors' ability to treat their patients, might read this and see that forcing tapers on patients is dangerous. There have already been many suicides because of them.

A gap is growing between many doctors and their patients. We know this is not “What's best for us.” It is actually a twisted way to make more money off the sick and vulnerable, forcing us to replace a medicine that is effective and safe when used responsibly with drugs that are ineffective, expensive and dangerous.

Emily Ullrich lives with Complex Regional Pain Syndrome (CRPS), chronic pancreatitis, endometriosis,  interstitial cystitis, migraines, fibromyalgia, osteoarthritis, anxiety, insomnia, depression, and other chronic illnesses. She is also a writer, filmmaker, activist, advocate, philanthropist and comic. As she is able, Emily devotes her time and energy fighting for pain patients’ rights.

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.

Fentanyl May Be Classified as Weapon of Mass Destruction

By Pat Anson, PNN Editor

The Trump Administration is considering labeling fentanyl as a weapon of mass destruction, according to an internal Homeland Security memo obtained by the military news website Task & Purpose.

"Fentanyl's high toxicity and increasing availability are attractive to threat actors seeking nonconventional materials for a chemical weapons attack," wrote James McDonnell, a DHS assistant secretary, in a February 22, 2019 memo to then-DHS Secretary Kirstjen Nielsen.

According to the memo, the FBI considers fentanyl “a viable option for a chemical weapon attack by extremists or criminals.”  The idea of labeling fentanyl a weapon of mass destruction (WMD) is also under consideration by the Department of Defense.

“Within the past couple years, there has been reinvigorated interest in addressing fentanyl and its analogues as WMD materials due to the ongoing opioid crisis,” McDonnell wrote.

DEA IMAGE

Fentanyl is a synthetic opioid, 50 to 100 more potent than morphine, that is legally prescribed to treat severe chronic pain. In recent years, bootleg versions of fentanyl and its chemical cousins have flooded the black market, where they are often added to heroin and cocaine to boost their potency or used in the manufacture of counterfeit medication.

According to the CDC, fentanyl is involved in more overdoses than another drug and was linked to 18,835 drug deaths in 2016.

Most of the black market fentanyl is produced by drug labs in China and then smuggled into the U.S. from Mexico or shipped through the mail.  

Designating fentanyl as a WMD would enable Homeland Security to increase funding for sensors and other technology that can detect fentanyl being smuggled in vehicles, packages and shipping containers.

A WMD expert told Task & Purpose the idea of fentanyl being used as a weapon was a “fringe scenario” because there are dozens of toxic chemicals that can be easily weaponized.

"It reads like somebody is laying the administrative background for trying to tap into pots of money for detecting WMD and decontaminating WMD," said Dan Kaszeta. "It's an interdepartmental play for money, that's all it is."

An unnamed senior defense official quoted by Task & Purpose was also skeptical.

"Anybody with a college level degree in chemistry can manufacture chemical weapons agents," the defense official said. “I cannot see any scenario where a nation-state would use fentanyl on the battlefield, or for that matter, a terrorist using a really toxic chemical like fentanyl in an attack when they could just sell it for funding the purchase of firearms and explosives or steal an industrial chemical instead.”

China recently agreed to ban all “fentanyl-related substances” by listing them as controlled substances. The move is meant to close a loophole that allowed drug labs to make novel variations of fentanyl that are not technically illegal.

Fentanyl Myths

While fentanyl is a scourge on the black market, drug experts say it’s not nearly as hazardous as it is often portrayed. Reports of first responders becoming severely ill after skin contact with fentanyl are likely the result of panic attacks.

“One of the issues with this dramatization of fentanyl toxicity is that it further stigmatizes substance users as contagious and dangerous. That can potentially delay care to those who need prompt rescue and treatment,” emergency medicine physicians Lewis Nelson, MD, and Jeanmarie Perrrone, MD, wrote in STAT News.

“There is no documented evidence of responders becoming ill after skin contact with fentanyl.”

— Health Canada

“There is clear evidence that passive exposure to fentanyl does not result in clinical toxicity. Descriptions of the signs and symptoms of those who have supposedly experienced passive toxicity vary widely. They include dizziness, blurry vision, pallor, weakness, sweatiness, high blood pressure, chest pain, heart palpitations, anxiety, and occasionally seizure-like activity. These findings are usually transient and resolve on their own, often far faster than would be expected, and are incompatible with the known duration of the drug’s effect.”

A fact sheet released by Health Canada also dispels some of the myths about fentanyl, telling first responders that skin exposure is “extremely unlikely to immediately harm you” and “there is no documented evidence of responders becoming ill after skin contact with fentanyl.”

Fentanyl has been used in at least one terrorist incident —- by law enforcement. In 2002, Russian police pumped an aerosol version of fentanyl into a Moscow theater where terrorists were holding hundreds of hostages. The gas inadvertently killed 117 of the hostages.

60 Arrested in Latest Crackdown on Rx Opioids

By Pat Anson, PNN Editor

Sixty people in five states face charges of illegal opioid prescribing and healthcare fraud in the latest federal crackdown on opioids. The arrests are the first since the Justice Department established an opioid strike force last year to concentrate on drug crimes in the Appalachian region.

The defendents include 31 doctors, 7 pharmacists, 8 nurse practitioners and 7 other licensed medical professionals.

“The opioid epidemic is the deadliest drug crisis in American history, and Appalachia has suffered the consequences more than perhaps any other region,” Attorney General William Barr said in a statement. 

“But the Department of Justice is doing its part to help end this crisis. One of the Department's most promising new initiatives is the Criminal Division's Appalachian Regional Prescription Opioid Strike Force, which began its work in December.  Just four months later, this team of federal agents and 14 prosecutors has charged 60 defendants for alleged crimes related to millions of prescription opioids.” 

The charges involve over 350,000 opioid prescriptions and over 32 million pills. A federal prosecutor claimed that was the equivalent of a dose of opioids for every man, woman and child in Ohio, Kentucky, Tennessee, West Virginia and Alabama.

In one case, a doctor and several pharmacists are accused of operating a pill mill in Dayton, Ohio. Over a two-year period, the pharmacy dispensed over 1.75 million pills. 

In Kentucky, a doctor operating a pain management clinic allegedly provided pre-signed, blank prescriptions to office staff who then used them to prescribe controlled substances when he was out of the office. 

And in Tennessee, a doctor who called himself the “Rock Doc” allegedly prescribed dangerous combinations of opioids and benzodiazepines, sometimes in exchange for sexual favors.

“Reducing the illicit supply of opioids is a crucial element of President Trump’s plan to end this public health crisis,” Health and Human Services Secretary Alex Azar said in a statement.  “It is also vital that Americans struggling with addiction have access to treatment and that patients who need pain treatment do not see their care disrupted, which is why federal and local public health authorities have coordinated to ensure these needs are met in the wake of this enforcement operation.”

A DOJ press release provided a list of hotlines, websites and other resources where effected patients can get addiction treatment. None of them, however, appear to offer pain management.

Pain patients are often the forgotten victims in law enforcement crackdowns on healthcare providers. Dawn Anderson, for example, a double amputee and diabetic, died last month in “sheer agony” because she was no longer able to get opioid medication from a pain management doctor who stopped practicing medicine after he was accused and convicted of healthcare fraud.    

Most Overdoses Don’t Involve Rx Opioids

The Appalachian region – and West Virginia in particular – has been ground zero in the opioid crisis. But a new study by researchers at West Virginia University shows just how much the crisis has shifted away from prescription opioids.

Researchers analyzed over 8,800 drug-related deaths in West Virginia from 2005 to 2017 and found that deaths involving fentanyl soared by 1,325% over that period.

From 2005 to 2014, prescription opioids were involved in almost 60% of drug related deaths in West Virginia, but from 2015 to 2017 they were only involved in about 30% of drug deaths.

West Virginians are now twice as likely to die from fentanyl than they are from oxycodone. Deaths linked to fentanyl, heroin, alcohol, alprazolam (Xanax) and cocaine outnumber those from oxycodone or any other opioid pain reliever.

Fentanyl and its analogs are synthetic opioids 50-100 stronger than morphine. They’ve become a scourge on the black market, where they are frequently mixed with heroin and cocaine to boost their potency or used in the manufacture of counterfeit medication.

Reducing the supply of prescription opioids and locking up doctors isn’t going to solve the fentanyl problem.

"One of the proven ways to reduce overdoses is to decrease the number of people who are addicted and using. But with fentanyl, you could halve the number of addicts in West Virginia, and the overdose rate could still go up because the strength of the drug coming in is so much stronger and can vary widely from one day to the next," said Gordon Smith, MD, an epidemiologist in the West Virginia School of Public Health. "This is an absolute quandary."

West Virginia's increase in fentanyl-related deaths is part of a national trend. As the CDC reported, deaths from fentanyl overdoses spiked across the United States in 2015 and are still climbing. West Virginia leads the nation in fentanyl-related deaths and has the highest per capita rate of overdose deaths overall.

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."

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.

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.

CVS Fined $535,000 for Filling Forged Opioid Prescriptions

By Pat Anson, PNN Editor

CVS Pharmacy has agreed to pay a $535,000 fine to resolve allegations that several of its Rhode Island stores filled dozens of forged prescriptions for Percocet, a potent opioid painkiller. It’s the latest in a series of fines the nation’s largest pharmacy chain has paid for violations of the Controlled Substances Act.

According to DEA investigators, CVS pharmacists filled 39 forged prescriptions for Percocet between 2015 and 2017 even though they “knew or had reason to know that the prescription in question was invalid or unauthorized.”

In a settlement agreement with the Department of Justice, CVS agreed to pay the fine while making no admission of any liability or wrongdoing. The company said it wanted to avoid the expense and uncertainty of going to trial. In return, the DOJ agreed to drop all civil or criminal prosecution of the case.

“DEA registrants like CVS have a corresponding responsibility to dispense controlled substances in accordance with the Controlled Substance Act,” said DEA Special Agent in Charge Brian Boyle. 

“Pharmacies put patients at risk when they dispense Schedule II narcotics, which have the highest potential for abuse, without a valid and legal prescription.  Today’s settlement demonstrates DEA’s commitment to work with our law enforcement and regulatory partners to ensure that these rules and regulations are followed.”

It’s not the first time CVS has been accused of lax or fraudulent behavior involving opioid medication.

In 2017, CVS agreed to pay a $5 million fine to settle allegations that several of its pharmacies in California failed to detect thefts of the opioid painkiller hydrocodone.

In 2016, CVS agreed to pay a $3.5 million fine to resolve allegations that 50 of its pharmacies in Massachusetts and New Hampshire filled forged prescriptions for opioids. One forger signed a dentist’s name on 131 prescriptions for hydrocodone and had them filled at eight different CVS stores.

And in 2015, CVS paid a $22 million fine after two of its pharmacies in Florida were found to be routinely filling bogus prescriptions for painkillers, including some for customers as far away as Kentucky.

All of these cases were settled out of court.

In 2018, CVS angered pain patients when it began to limit the initial dose of opioids to 7 days’ supply for customers enrolled in CVS Caremark health plans. For both acute and chronic pain patients, CVS said daily doses of opioids should not exceed 90 MME (morphine milligram equivalent) and patients would be required to use immediate release formulations. CVS said it was making the CDC opioid guideline the “default approach” to prescribing opioids.

Last week, CDC Director Dr. Robert Redfield acknowledged for the first time the agency’s voluntary guideline was causing “unintended harms” and that patients should only be tapered to lower doses “if a patient would like to taper.”  

“The Guideline does not endorse mandated or abrupt dose reduction or discontinuation, as these actions can result in patient harm,” Redfield said. “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.”

Nothing in the guideline empowers pharmacists to set dose limitations. CVS operates 9,700 pharmacies and 1,100 walk-in medical clinics nationwide

Biden: ‘A Little Pain Is Not Bad’

By Pat Anson, PNN Editor

Former Vice-President Joe Biden, who appears close to announcing a run for president in 2020, may want to think twice about the message he’s sending to a large group of voters: chronic pain patients.

While speaking Thursday as part of a panel on the opioid crisis at the University of Pennsylvania, Biden said too many doctors “willy-nilly overprescribed” opioid pain relievers.

"A little pain is not bad," said Biden. “A lot of people can get addicted within five days.”

FORMER VICE-PRESIDENT JOE BIDEN

“We got here, I believe in part, because of the greed of the drug companies and the irresponsibility of them and, quite frankly, a lack of sufficient responsibility on the part of the medical profession,“ Biden said, adding that 215 million prescriptions for opioids were written in 2016.

“We desperately need people with chronic pain to have this access, but you cannot convince me anywhere near that is the case,” he said.

The 76-year old former senator also expressed regret about being a co-sponsor of the 1988 Anti-Drug Abuse Act, which created tougher sentencing guidelines for crack cocaine. Critics say the law sent a disproportionate share of African-Americans and other minorities to prison.

"The big mistake was us buying into the idea that crack cocaine was different from the powder cocaine, and having penalties ... it should be eliminated," Biden said, according to Delaware Online. “I’m sorry I didn’t know more about behavior.”

Biden’s knowledge about the opioid crisis appears dated. The vast majority of overdose deaths are now attributed to illicit fentanyl, heroin and other black market opioids, not pain medication. The number of opioid prescriptions has also been declining for several years and now stand at their lowest level since 2003.

Prescription opioids are not particularly risky if used responsibly, according to a recent study of over half a million Medicare patients who were prescribed the drugs. Over 90 percent had a negligible risk of an overdose. Even among “high risk” patients on high opioid doses, the risk of an overdose is less than two percent.  

A major review of studies on long term opioid therapy found that only 0.27% of patients were at risk of opioid addiction, abuse or other serious side effects. In another large study, The British Medical Journal reported that only 3% of opioid naïve patients (new to opioids) continued to use the drugs 90 days after a major elective surgery.

Biden’s advice to pain sufferers that “a little pain is not bad,” is reminiscent of a statement by former Attorney General Jeff Sessions, who told a Florida audience in 2018 that "people need to take some aspirin sometimes and tough it out.”

You can watch the opioid panel discussion on YouTube by clicking here.

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.    

ROBERT REDFIELD, md

“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.

“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.

FDA Warns About Fast Opioid Tapers

By Pat Anson, PNN Editor

The U.S. Food and Drug Administration issued an unusual warning Tuesday cautioning doctors not to abruptly discontinue or rapidly taper patients on opioid pain medication.

The agency said in a statement it had received reports of “serious harm in patients who are physically dependent on opioid pain medicines suddenly having these medicines discontinued or the dose rapidly decreased.” The harm includes withdrawal symptoms, uncontrolled pain, psychological distress and suicide.

The FDA gave no details on cases of patient harm but said it was tracking them and would require changes on opioid warning labels to help instruct physicians on how to safely decrease opioid doses.

“Rapid discontinuation can result in uncontrolled pain or withdrawal symptoms. In turn, these symptoms can lead patients to seek other sources of opioid pain medicines, which may be confused with drug-seeking for abuse. Patients may attempt to treat their pain or withdrawal symptoms with illicit opioids, such as heroin, and other substances,” the FDA said.

In recent years, there have been an increasing number of anecdotal reports of pain patients committing suicide or turning to illegal drugs for pain relief. It is not clear why the FDA decided to act now, just days after the departure of former FDA commissioner Scott Gottlieb, MD.

In PNN’s recent survey of nearly 6,000 patients, over 80 percent said they had been taken off opioids or had their dose reduced. Nearly half said they had considered suicide because their pain is poorly treated and many were turning to other substances – both legal and illegal – for pain relief.

• 11% obtained opioid medication from family, friends or black market

• 26% used medical marijuana for pain relief

• 20% used alcohol for pain relief

• 20% used kratom for pain relief

• 4% used illegal drugs (heroin, illicit fentanyl, etc.) for pain relief    

Last December, over a hundred healthcare professionals warned in a joint letter to the Department of Health and Human Services that forced opioid tapering has led to “an alarming increase in reports of patient suffering and suicides” and called for an urgent review of tapering policies at every level of healthcare.

“This is a large-scale humanitarian issue,” the letter warns. “New and grave risks now exist because of forced opioid tapering.” 

Federal agencies widely differ on opioid tapering recommendations. The Centers for Disease Control and Prevention recommend a "go slow" approach, with a "reasonable starting point" being 10% of the original dose per week. Patients who have been on opioids for a long time should have even slower tapers of 10% a month, according to the CDC.

The Department of Veterans Affairs recommends a taper of 5% to 20% every four weeks, although in some cases the VA suggests an initial rapid taper of 20% to 50% a day “if needed.”

In its warning, the FDA cautioned doctors that no standard opioid tapering schedule exists that is suitable for all patients.

“When you and your patient have agreed to taper the dose of opioid analgesic, consider a variety of factors, including the dose of the drug, the duration of treatment, the type of pain being treated, and the physical and psychological attributes of the patient,” the FDA said. “Create a patient-specific plan to gradually taper the dose of the opioid and ensure ongoing monitoring and support, as needed, to avoid serious withdrawal symptoms, worsening of the patient’s pain, or psychological distress.”

The FDA urged patients and doctors to report side effects from opioid discontinuation and rapid tapers at druginfo@fda.hhs.gov or to call 855-543-DRUG (3784) and press 4.

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.   

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

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. 

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! 

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.)

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.

Canada Forms Chronic Pain Task Force

By Marvin Ross

Canadian chronic pain patients were given a glimmer of hope this week when federal health minister Ginette Petitpas Taylor announced the establishment of a national task force to examine how to prevent and manage chronic pain and remove barriers to pain treatment.

“This is the first step in addressing the issue of chronic pain in this country,” Ginette Petitpas Taylor said at the annual meeting of the Canadian Pain Society in Toronto. “We have to recognize that Canada’s a big country and we certainly know there’s inconsistent services in provinces and territories, so I have to really have a good understanding of what’s available and what’s happening out there.”

One in five Canadians lives with chronic pain and -- like their counterparts in the U.S. – many have been on the receiving end of the crackdown on opiates.

After the U.S. Centers for Disease Control and Prevention released its 2016 opioid guideline, Canada followed with its own very similar set of recommendations, which were developed by a panel at McMaster University chaired by lead investigator Dr. Jason Busse, a chiropractor.

Although the guidelines are voluntary, medical regulatory colleges across Canada have been pressuring their physician members to drastically reduce opioid prescribing and many doctors now fear for their licenses if they don’t comply.

Petitpas Taylor acknowledged that Canada’s response to the overdose crisis contributed to “stigmatizing attitudes and behaviours” about opioids and created barriers “that may prevent people with chronic pain from receiving the health services they need.”

She said the task force will consult with governments and advocacy groups, and provide an initial report to Health Canada in June, followed by two more in 2020 and 2021.

The panel has two co-chairs. Dr. Fiona Campbell is a pediatric anesthesiologist and Associate Professor in the Department of Anaesthesia & Pain Medicine at the University of Toronto. The other co-chair is Maria Hudspith, who is the Executive Director of Pain BC, a non-profit charity working to improve the lives of people in pain.

Both co-chairs have been on the syndicated Roy Green Show discussing the increasing problems faced by pain patients. In 2017, Campbell told Green that patients who need opiates should not be marginalized and that opiates should be used when all other treatment modalities have failed. Hudspith was a guest on the Green show last year and is well aware that patients have been forcibly tapered or cut off from opioids and often have problems finding care.

That gives me some hope, as does the fact that the other six members of the task force are a combination of medical specialists and pain patients themselves. But not everyone is pleased with the appointments or that the panel’s work will take up to three years.

“Of course, we are happy they are actually acknowledging chronic pain is an issue. However, the time frame is wrong and a little bit too late. We are also quite disappointed in the individuals who have been chosen to lead this task force,” said Barry Ulmer of the Chronic Pain Association of Canada. “Although we were consulted to a degree, it seems our voices were not heard to any large extent.” 

"My colleagues and I provided a list of names of pain physicians who have decades worth of practical experience and have worked diligently to hone their knowledge and skills. We were extremely disappointed not to see a single name from this list appointed to the task force,” said Ann Marie Gaudon, a social worker, pain patient and PNN columnist. 

“Additionally, while we appreciate the Minister's efforts in setting up this task force, solutions must be found now or there will be more deaths and increasing needless suffering. These severely pained and severely stigmatized patients who have been forced off of necessary medications just do not have three years to wait for more information that we already have. There is an extreme urgency here that is not being addressed as such."

Chronic pain in Canada costs up to $60 billion per year in direct health care costs and lost productivity due to job loss and sick days. 

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.

39 Attorneys General Practicing Medicine Without a License

By Pat Anson, PNN Editor

Over 5,000 healthcare providers, patients, caretakers and advocacy organizations have left comments in the Federal Register on a draft report by a federal advisory panel known as the Pain Management Best Practices Inter-Agency Task Force. The comment period ended April 1.

Most of the comments – which you can see by clicking here – are supportive of the report, which recommends that pain management be balanced, multimodal and focused on individualized patient care. Opioid pain medication should be prescribed cautiously, if prescribed at all, according to the task force.

Those may sound like reasonable and prudent goals, but one aspect of the draft report has stirred controversy and it’s a familiar one: the CDC’s 2016 opioid prescribing guideline.

While commending its “useful general guidance,” the report found that that guideline has had many unintended consequences, including forced opioid tapering, patient abandonment and suicide. The task force said the guideline was never meant to be mandatory or to be used as a model by states, insurers and pharmacies, and better evidence was needed to support its recommendations.

The task force stopped short of recommending a wholesale revision of the guideline, but suggested a “more even-handed approach” to pain care was needed.  

“In essence, clinicians should be able to use their clinical judgement to determine opioid duration for their patients,” the report concludes.

Those were fighting words to some anti-opioid crusaders and politicians who consider the CDC guideline a cornerstone of the government’s war on drugs.

“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 that causes nearly 50,000 deaths annually,” warns a letter signed by 39 state and territory attorney generals.  “It is incomprehensible that officials would consider moving away from key components of the CDC Guideline.”

‘They Have Overreached’

The AG’s letter shows a fundamental and perhaps willful ignorance of what the guideline is – a voluntary set of recommendations intended only for primary care physicians. The letter also demonstrates how politicians have grown accustomed to inserting themselves into pain management decisions normally left between patients and their doctors. In essence, the AG’s are saying that doctors should not be allowed to use their own clinical judgement and should rely instead on treatment guidelines.  

“The Draft Report proposes to rely solely on the judgment of providers regarding the dose and duration of opioid treatment. With annual overdose deaths in the tens of thousands, evidence-based recommendations, such as documentation and consultation, are necessary,” the AG letter states. “Similarly, the Draft Report states that duration of opioid treatment for acute pain, including trauma and surgery, is best determined by providers without the need for guidelines to inform appropriate decision-making.”

Critics say the AG’s are essentially practicing medicine without a license.

“The foxes watching the hen house want more hens to watch, more justification for their existence,” says Mark Ibsen, MD, a Montana doctor all too familiar with government intrusion into pain care. Ibsen’s medical license was suspended in 2016 over allegations that he overprescribed opioids, a decision later reversed by a judge.

“They have overreached. I hope someone else notices, and takes law enforcement out of the practice of medicine, where they’ve been screwing up medical care since 1914. Abolish the DEA. Let law enforcement catch criminals, not make them up out of thin air,” Ibsen said.

This isn’t the first time the National Association of Attorneys General has tried to meddle in pain care. In 2017, the organization sent a letter to health insurers asking them to take steps to reduce the prescribing of opioid medication.

“Reducing the frequency with which opioids are prescribed will not leave patients without effective pain management options.”

— National Assn. of Attorneys General

“Reducing the frequency with which opioids are prescribed will not leave patients without effective pain management options,” the 2017 letter states. “When patients seek treatment for any of the myriad conditions that cause chronic pain, doctors should be encouraged to explore and prescribe effective non-opioid alternatives, ranging from non-opioid medications (such as NSAIDs) to physical therapy, acupuncture, massage, and chiropractic care.”

In their latest letter, it’s no longer a matter of “should.” The AG’s say doctors “must be encouraged” to reduce opioid prescriptions and to recognize that opioids have “well established risks.”  

“The Draft Report should be revised to clearly state that there is no completely safe opioid dose, and that higher doses are particularly – and predictably – risky,” the AG’s wrote.

But most opioid medications are not particularly risky, as PNN reported in a recent study of over half a million Medicare patients who were prescribed the drugs. Over 90 percent had a negligible risk of an overdose. Even among “high risk” patients on high opioid doses, the risk of an overdose is less than two percent.

‘Too Much Money On the Line’

Critics also point out the AG’s have a political and financial interest in demonizing opioid medication. Most have signed on as plaintiffs in over 1,600 class action lawsuits filed by states, cities and counties seeking billions of dollars in damages from opioid manufacturers and distributors. Oklahoma Attorney General Mike Hunter – one of the AG’s who signed the letter criticizing the task force report --  recently reached an out-of-court settlement with Purdue Pharma for $270 million.  

“There is just too much potential money on the line. This is not an argument about truth, or evidence, or anything except money," says Andrea Anderson, Executive Director of the Alliance for the Treatment of Intractable Pain (ATIP).  

“Since the Purdue/Oklahoma settlement of $270 million, all the AG’s of every state involved in this opioid litigation will focus solely on their potential financial gains until they get their piece of settlement pie. This will come at the cost of needed revisions to the flawed CDC Guidelines and a return to clinical common sense. People can remember these AG’s when they vote.” 

According to OpenSecrets.org, the law firm of Simmons Hanly Conroy donated over $1 million to congressional candidates during the 2018 election cycle. Simmons Hanly Conroy represents dozens of states and local governments that are suing drug makers over their marketing of opioids, and would pocket one-third of the proceeds from any settlements, according to reports.

A recent PNN survey found the CDC guideline was having a harmful effect on both patients and healthcare providers. Over 85 percent of patients say the guideline has made their pain and quality of life worse. Nearly half have considered suicide. Over two-thirds of practitioners are worried about being sanctioned or prosecuted for prescribing opioids. Rather than risk going to prison, many have stopped treating pain, closed their practice or retired.  

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.

Study Finds 90% of Medicare Patients Have Little Risk of Opioid Overdose

By Pat Anson, PNN Editor

Current methods used to identify Medicare patients at high risk of overdosing on prescription opioids target many people who are not really at high risk, according to a team of researchers who found that over 90% of patients have little to no risk of overdosing.

"The ability to identify such risk groups has important implications for policymakers and insurers who currently target interventions based on less accurate measures,” said lead author Wei-Hsuan "Jenny" Lo-Ciganic, PhD, a professor of pharmaceutical outcomes and policy at the University of Florida, who reported her findings in JAMA Network Open.  

Lo-Ciganic and her colleagues at the University of Pittsburgh, Carnegie Mellon University and University of Utah studied health data on over half a million Medicare beneficiaries who filled one or more prescriptions for opioids between 2011 and 2015. The researchers identified which patients overdosed and then used machine-learning algorithms to analyzed their demographics and health records.

The computer models developed three risk groups that predict which patients are at risk of overdosing over a 12 month period.

• Low risk patients (67.5%) have 0.006% risk of overdose

• Medium risk patients (23.3%) have 0.05% risk of overdose

• High risk patients (9.1%) have 1.77% risk of overdose  

Put another way, out of 100,000 Medicare patients in the low risk group, six would have an overdose; while there would be 1,770 overdoses in a high risk group of the same size.

Not surprisingly, the computer models found that high doses of opioids and a prior history of substance abuse significantly raise the risk of an overdose. So does a person’s age, disability status and whether they are co-prescribed benzodiazepines. Patients who live in certain states (Florida, Kentucky or New Jersey) are also at higher risk.

Top 10 Predictors of Opioid Overdose

1. Total MME (morphine milligram equivalent)

2. History of substance or alcohol abuse

3. Average daily MME

4. Age

5. Disability status

6. Number of opioid refills

7. Resident state

8. Type of opioid

9. Number of benzodiazepine refills

10. Drug use disorders  

The study found that the machine-learning algorithms the researchers developed performed well in predicting overdose risk and in identifying patients with a low risk. Machine learning is an alternative analytic approach to handling complex interactions in large data.  It can discover hidden patterns and generate predictions in clinical settings. Based on their findings, the researchers concluded that their approach outperformed other methods for identifying risk used by the Centers for Medicare and Medicaid Services.

"Machine-learning models that use administrative data appear to be a valuable and feasible tool for identifying more accurately and efficiently individuals at high risk of opioid overdose," says Walid Gellad, MD, a professor of medicine at the University of Pittsburgh and senior author on the study. "Although they are not perfect, these models allow interventions to be targeted to the small number of individuals who are at much greater risk."