Pain Patients Worried About CDC Expanding Opioid Guideline

By Pat Anson, PNN Editor

 “These guidelines have been a disaster for people with chronic pain.” 

“The guideline is flat out wrong on facts, wrong on science and wrong on medical ethics.” 

“The CDC has no qualifications or authority to develop pain management guidelines, especially those pertaining to opioid therapy.” 

Those are just a few of the comments we received from nearly 4,200 pain patients and healthcare providers who participated in PNN’s survey on impending changes to the CDC's opioid prescribing guideline. 

“It has been misunderstood, misapplied, bastardized and weaponized to use against chronic pain patients,” is how one pain sufferer put it.  

People obviously have strong opinions about the CDC guideline. Can it be changed and made more effective? Or should the entire guideline be thrown out? 

Nearly 75% of the people we surveyed believe the guideline should be withdrawn or revoked. That’s not likely to happen, however, as the CDC completes a lengthy review and update of the guideline that started two years ago.

If anything, the agency seems intent on expanding the guideline to include specific recommendations for treating short-term acute pain, migraine and possibly other pain conditions such as fibromyalgia. 

That’s the route recently taken by two advisory panels in Europe, which released guidelines that are even stricter on the use of opioids than the CDC’s.

WHAT SHOULD BE DONE WITH CDC OPIOID GUIDELINE?

This month the UK’s National Institute for Health and Care Excellence advised doctors not to prescribe opioids or any other pain reliever for fibromyalgia, chronic headache, musculoskeletal pain and other types of “primary chronic pain” for which there is no known cause.

In March, the European Pain Federation (EFIC) released similar guidelines, saying “opioids should not be prescribed for people with chronic primary pain as they do not work for these patients.”

At least two members of Physicians for Responsible Opioid Prescribing (PROP), an anti-opioid activist group, served as consultants to the EFIC in making its recommendation. PROP has long urged the CDC to make a similar statement in its guideline.

“This recommendation should explicitly state that opioids should be avoided for fibromyalgia, chronic headache and chronic low back pain,” PROP’s board wrote in a 2015 letter to the CDC’s Dr. Deborah Dowell, one of the co-authors of the 2016 guideline. “We are suggesting this change because evidence-based reviews and expert consensus have found the long-term use of opioids is likely to be counter-productive for fibromyalgia, chronic headache and chronic axial low back pain.”

PROP didn’t get its explicit statement in 2016, but it may be getting another chance as the CDC revises and possibly expands its guideline.

Little Support for Guideline Expansion

In our survey, patients and providers seem to be wary about expanding the guideline to include treatment recommendations for specific conditions. Only about 40% support guidelines for low back pain, fibromyalgia and short-term acute pain. Many believe the CDC has already gone too far and some wonder where the agency gets the regulatory authority to create guidelines for medical conditions.    

“CDC should never have developed and issued opioid prescribing guideline, as such work falls outside CDC's mission and expertise. If guidelines are needed, FDA should write,” one respondent said.

“The CDC guideline would be fine, if if were not being weaponized. There is nothing wrong with having guidelines for non-specialists. However, insurance companies have grabbed hold of it and are now using it to deny coverage of what they think is outside the guidelines,” said another.  

“Pain and it’s treatment should have a guideline but with the acknowledgment that its never one size fits all,” a patient wrote. “Some standardized measures are useful to help physicians make decisions in acute, cancer, non-cancer pain, and non-narcotic options should be sought first.”

SHOULD CDC MAKE RECOMMENDATIONS FOR TREATING LOW BACK PAIN, FIBROMYLAGIA AND OTHER PAIN CONDITIONS?

Strong Opposition to 90 MME Limit

If there’s anything that patients and providers want changed, it’s the guideline’s recommended dose limit of 90 MME (morphine milligram equivalent). Although voluntary, the daily dose limit has been rigidly applied by many doctors, pharmacists, insurers and regulators. As a result, patients who’ve taken higher doses of opioids for years — and done it safely — suddenly found themselves being tapered to 90 MME or less.

“My spouse has Ehlers Danlos Syndrome. Her chronic severe pain kept her bedridden for years until a doctor found an opioid regimen that worked. She had her life back and was able to function out of bed. This worked for over 12 years,” one man told us.

“Now, the CDC guidelines have caused local practitioners to require cutting her MME equivalent per day from about 300 to 90. They fear liability. When they discuss tapering and are confronted with the question, ‘But this is a genetic tissue disorder, it is not going to taper away,’ they have nothing to say except to point the finger at the CDC and say they are afraid of being sued. This is going to put her back in bed and, I'm afraid, kill her.”

Asked what changes should be made to the CDC’s recommended dose limit of 90 MME, nearly 87% said there should be no limit on opioid dosages.

“My doctor drastically reduced my medication and I suffer for it. Can hardly walk, can't function like I want to, no one cares as long as its 90 MME. Doesn't matter if I require higher dose and have tolerated it just fine for years,” a patient said.

“I was force tapered in 2016. I've been unable to fill legitimate prescriptions several times and denied meds by my insurance unless I use what they say is equivalent,” a patient told us.

“I was forced tapered from 550mg down to 90mg without my consent,” another patient wrote.

“Pretty much told that I would either take the lower prescribed dose or suck it up without pain relief,” said another.

WHAT CHANGES SHOULD BE MADE TO CDC'S DOSE LIMIT OF 90 MME?

“All of a sudden you can't have your regular prescription. Doesn't matter if it effects my health adversely. Blood pressure through the roof, NEVER had that problem before with it, but keep that 90 MME no matter what. Doctors sympathize but they are too scared to help you,” another patient said. “This rule doesn't help chronic pain patients at all and it doesn't stop overdoses. It needs to change.”

“My physician has been told by the hospital board that they have to reduce the amount of pain medication to ALL patients to an equivalent of 90mg. I have been taken off 70mg of my pain medications that I have taken for over 20 years,” wrote yet another patient.

“The doctor has told me he must continue to taper me more. He knows I am suffering but his hands are tied. The CDC must allow physicians that are experts in the pain management field to treat their patients as individuals. I have a lot more to say but can not type anymore as it causes me great amount of pain to use my hands and fingers.”

We received thousands of comments like these from patients, doctors, caretakers, spouses and loved ones.

One of the more poignant ones came from an intractable pain patient who considers herself lucky to have a doctor who slowly tapered her down to 90 MME. That doctor has now retired. She fears for her future and those of other patients.

“It’s my feeling we’ll look back on all this one day and realize this was in every aspect of the word a genocide; an attack on the weakest of us, the ones who most needed protection, but were mercilessly denied it.”

— Intractable Pain Patient

“I’ve managed to get to 90 MME from a dose much higher, as I was most definitely a high dose patient, but it only happened because I had good care for all those years,” she said. “I experience more nerve pain now than ever before, and I still very much fear being cut off.

“God bless any doctor or human being who’s willing to support us during this terrible most tragic of times. We’re being put in a position to lose all semblance of pain management for good if this downward spiral is allowed to continue. That’s such an inhumane and ugly thing to do, after countless lovely vibrant lives have been snuffed out by the lack of it already. It’s my feeling we’ll look back on all this one day and realize this was in every aspect of the word a genocide; an attack on the weakest of us, the ones who most needed protection, but were mercilessly denied it.”

(PNN’s survey was conducted online and through social media from March 15 to April 17. A total of 4,185 people in the United States participated, including 3,926 who identified themselves as chronic, acute or intractable pain patients; 92 doctors or healthcare providers; and 167 people who said they were a caretaker, spouse, loved one or friend of a patient. Thanks to everyone who participated in this valuable survey. To see the full survey findings, click here.)

Patients Say CDC Opioid Guideline Made Their Pain Worse

By Pat Anson, PNN Editor

Nine out of ten pain patients say their pain levels and quality of life have grown worse since the Centers for Disease Control and Prevention released its 2016 opioid guideline, according to a large new survey by Pain News Network. Over half say they were taken off opioids or tapered to a lower dose against their wishes.

Nearly 4,200 people in the U.S. participated in the online survey, including 3,926 who identified themselves as chronic, acute or intractable pain patients.

The CDC’s controversial guideline discourages doctors from prescribing opioids, particularly in doses that exceed 90 morphine milligram equivalents (MME) per day. Although voluntary and only intended for primary care physicians, the guideline has had a sweeping effect on virtually every aspect of pain management, with many of its recommendations adopted as the standard of care by doctors, pharmacies, insurers, regulators and law enforcement.

Asked what has happened to their opioid prescriptions since the CDC guideline was released, one in four patients said they are no longer prescribed opioids and nearly 56% said they are getting a lower dose.

“These CDC rules are cruel and abusive to patients like myself. I never have even 5 minutes without debilitating pain now because I’m not allowed to have the dosage I need to be comfortable. I do cry a lot and pray that God will end my suffering,” said one patient.

“My pain meds have been reduced by about 70% and I am in much more pain now. It is hard for me to eat and I have lost about 30 pounds and severely underweight,” said another.

“I have had no quality of life since my pain specialist took me off the meds 5 years ago. Now my life consists of sitting in a recliner all day long, with nothing to look forward to except weight gain,” a patient wrote.

WHAT'S HAPPENED TO YOUR OPIOID PRESCRIPTIONS SINCE 2016?

Opioid prescriptions were declining before the CDC guideline was released and now stand at their lowest level in 20 years. But reduced prescribing has had negligible impact on the overdose crisis – drug deaths are at record levels – and it’s come at significant cost to patients. Over 92% say their pain levels and quality of life have grown significantly worse or somewhat worse in the last five years.

“It has made my life hell. I can barely stand or walk. Every day is an endurance test. It is clear how much opiates worked for me,” a patient wrote.

“The effects on my physical, mental health and quality of life have been devastating. I can't take care of my home, I can't regularly do grocery shopping, attend my kids extra curricular events or have any form of family fun without immense suffering,” said another patient.

“These guidelines are destroying the lives of chronic pain patients! We didn't do anything to deserve the loss or great reduction of our medications, and we are losing quality of life and the ability to function,” a patient said.

WHAT'S HAPPENED TO YOUR PAIN AND QUALITY OF LIFE SINCE 2016?

“It’s astounding that in a theoretically free country that people who have committed no crime are sentenced to life sentences of intolerable pain that prevents us from working, driving any distance, visiting friends or family and being forced to expend funds and effort to see our pain doctor monthly to hopefully have our prescription renewed,” said another patient.

Many patients report that effective pain treatment is increasingly hard to find:

• 59% were taken off opioids or tapered to a lower dose against their wishes

• 42% had trouble getting an opioid prescription filled at a pharmacy

• 36% were unable to find a doctor to treat their pain

• 29% were abandoned or discharged by a doctor

• 27% had a doctor who stopped prescribing opioids

• 19% had a doctor close their practice or retire unexpectedly

• 13% had a doctor investigated by DEA, law enforcement or state medical board

“My life has been significantly changed for the worst since my doctor was unjustly arrested, and the government continues to delay his trial. I have complicated medical issues and can find no one to prescribe what I need,” a patient said.

“When the DEA raided my physiatrist's office and suspended his DEA and medical licenses, pending the outcome of their B.S. investigation, and I began to search for a new one, I learned that all of my doctor's patients (myself included) had been blacklisted by most of the remaining physiatrists and anesthesiologists or pain specialists in the state! Whenever a receptionist or nurse asked me who my previous physician was and I answered them, the phone call basically ended right there,” another patient wrote.

“This entire mess has caused massive suffering to chronic pain patients, worsening health, dangerous side effects from being forced to take other dangerous medications not made to treat pain, and numerous suicides,” another patient said. “Good doctors are now terrified of being wrongly targeted by the DEA, resulting in massive suffering and diminished patient care, and even doctors offices closing entirely.”

‘Please Give Me My Life Back’

Only about two percent of patients said they’ve found better alternatives to opioids. With effective pain care difficult to obtain, some patients are having suicidal thoughts or using illicit drugs.

• 35% have considered or attempted suicide due to poorly treat pain

• 10% have obtained prescription opioids from family, friends or the black market

• 9% have used illegal drugs for pain relief

“As a pain patient of over two decades I never had a problem until the CDC guidelines came out, since then I've had to see a psychiatrist, pain psychologist, endure nasty forced tapering, wrote suicide notes and caught myself walking out the back door to kill myself,” a patient said. “When will these losers understand nobody in their right mind wants to take opioids? The only reason pain patients take opioids is because we don't have anything else that works.”

“I started going to the methadone clinic. I couldn't find a doctor for my pain meds nor my nerve meds. I started using heroin as did my longtime girlfriend who fatally overdosed in 2019 amongst many other friends and family members and the methadone is not working for my pain,” another patient said.

“My daughter is 28 and has severe pain. The last two pain specialists she had quit due to the guidelines and now she can't find anyone who will help her. She is very suicidal and I know I will not have her much longer as she is extremely depressed,” a mother wrote. “The CDC guidelines will most likely kill my daughter. She has already attempted suicide.”

“I blame our governmental agencies for my suffering. I have thought about suicide and yet I'm a board member of our local Suicide Prevention Council. And as I sit here promoting wellness and suicide prevention, I can't help the physical and emotional pain that is ripping out my soul. It really pisses me off because I know my life doesn't have to be this way,” said another pain patient. ”Please give me my life back where I was able to function with my pain medicine.”

“The CDC has ruined my life,” said a patient who has had five back surgeries and needs a hip replacement. “Most of us in chronic pain contemplate committing suicide all the time. We are not addicts, we aren't getting high, we are trying to survive and be parents or productive members of society.”

Ironically, the risk of addiction and overdose appears to be low in the pain community. Only 8% of patients who participated in our survey said they’ve been given a referral or medication for addiction treatment. And less than one percent (0.55%) have suffered — and survived — an opioid overdose.

(PNN’s survey was conducted online and through social media from March 15 to April 17. A total of 4,185 people in the United States participated, including 3,926 who identified themselves as chronic, acute or intractable pain patients; 92 doctors or healthcare providers; and 167 people who said they were a caretaker, spouse, loved one or friend of a patient. Thanks to everyone who participated in this valuable survey. To see the full survey findings, click here.)

Patients and Providers Want CDC Opioid Guideline Revoked

By Pat Anson, PNN Editor

The CDC opioid prescribing guideline has failed to reduce addiction and overdoses, significantly worsened the quality of pain care in the United States and should be revoked, according to a large new survey of patients and healthcare providers by Pain News Network. Over two-thirds believe the federal government should not have guidelines for opioid medication and that treatment decisions should be left to patients and doctors.

Nearly 4,200 patients, providers and caretakers participated in PNN’s online survey, which was conducted as the Centers for Disease Control and Prevention prepares to update and possibly expand its controversial 2016 guideline.

Although voluntary and only intended for primary care physicians, the guideline has become the standard of care for pain management in the U.S., with many doctors, insurers, pharmacies and regulators adopting its recommendations as policy, such as limiting opioid doses to no more than 90 morphine milligram equivalents (MME) per day. Some providers have gone even further and stopped prescribing opioids altogether, rather than risk scrutiny from law enforcement or state medical boards.

The stated goal of the guideline was to “improve the safety and effectiveness of pain treatment” and reduce the risk of opioid addiction and overdose. But survey respondents overwhelmingly believe the CDC failed to achieve its goals, and that its recommendations have stigmatized patients and reduced access to pain management. When asked if the CDC guideline has improved the quality of pain care, nearly 97% said no.

“They have done immeasurable damage to chronic intractable pain patients all across America. There have been suicides, people have lost their jobs and their entire quality of life because of them,” one patient told us.

“In 40 years as a pain specialist, I have never seen patients with pain (acute, chronic and cancer) so mistreated, abandoned and unable to access pain treatment as a direct result of the CDC Guidelines,” a doctor wrote.

“Due to inadequate pain control many chronic pain patients, including myself, attempted suicide to get relief of intolerable pain. I wish I had succeeded,” another patient wrote.

HAS THE CDC OPIOID GUIDELINE IMPROVED THE QUALITY OF PAIN CARE?

Overdoses Rising

Except for a brief decline in 2018, opioid overdoses in the U.S. have steadily risen since the CDC guideline was released. When all the data comes in, 2020 is expected to be the deadliest year on record for opioid overdoses, the vast majority involving illicit fentanyl and other street drugs, not pain medication.  

Survey respondents are well aware of that fact. When asked if the CDC guideline has been successful in reducing opioid addiction and overdoses, nearly 92% said no.

“I view the CDC guidelines to be a desperate attempt to control the opioid overdose crisis by curtailing the ability of doctors and pharmacists to provide adequate, legally-prescribed pain relief,” a patient said. “It’s net effect has resulted in the suffering of thousands of chronic pain patients, while doing nothing to curtail the sale and use of illegal street drugs.”

“The guidelines are barbaric! It's not stopped overdoses from drugs being brought in by cartels. It's only harmed patients,” another pain sufferer told us.

“I've know far too many people in my circle of extended friends and family who have died of unintentional overdose. Many had valid pain issues. Had been under the care of a doctor. Then, as these new rules changed the playing field, doctors arbitrarily reduced prescriptions,” a patient said.

HAS THE CDC GUIDELINE REDUCED OPIOID ADDICTION AND OVERDOSES?

The CDC has been aware of these problems since the guideline’s inception. But not until 2019 did the agency acknowledge the guideline was harming patients and pledge to “clarify its recommendations.” Two years later, the CDC is still working on its clarification, which may not be finalized until 2022.

‘Throw the Whole Mess Out’

Most survey respondents – nearly 75% -- believe the entire guideline should be withdrawn or revoked. Less than one in four (23%) believe changes can be made to make the recommendations more effective. And fewer than one percent (0.38%) believe the guideline should be left the way it is.

“These guidelines need to be repealed and government needs to get out of the confidential doctor/patient relationship now and forever,” a patient wrote.

“The CDC guideline is interfering with the ethical practice of medicine between patients and physicians. There is never a ‘one size fits all’ model in medicine, and trying to create one is, and has been, detrimental to the doctor-patient relationship, and more importantly, to quality patient care in an underserved and vulnerable patient population,” a provider wrote.

“These guidelines have done more damage to acute and chronic pain patients than I have ever seen in practice. This is a decision between providers and patients, and federal government needs to stay out of it,” another provider wrote.

WHAT SHOULD BE DONE WITH CDC GUIDELINE?

CDC ‘Didn’t Care’ About Guideline’s Misapplication

The survey found a significant amount of distrust in CDC. Asked if the agency could handle the revision of the guideline in an unbiased, scientific and impartial manner, over 89% said no.

“Throw the whole mess out! Let our doctors decided what works for each patient for gods sake. Before we lose more people. And stop demonizing safe medication and pushing dangerous ones so big pharma can profit even more,” a patient wrote. “We KNOW what's going on here and its disgusting.”

“These guidelines are clearly biased to the point of corruption, and it has caused terrible disruption in the lives of literally millions of patients,” another patient said.

"It is unbelievable that this horrific mistake has not been rectified; the possibility that they are using the same biased, corrupt, incompetent committee to write the updates is purely fraudulent.”

DO YOU TRUST CDC TO REVISE THE GUIDELINE IN AN UNBIASED, SCIENTIFIC MANNER?

“While it is clear the CDC didn't intend the guidelines be used as law, it is also clear they didn't care that the guidelines were being misapplied, misunderstood, misappropriated and maliciously used to further an agenda not to help anyone,” a patient wrote.

Less than 4% of respondents believe the CDC is best qualified to create a federal guideline for opioid prescribing. About 9% would prefer to have the Food and Drug Administration write the guideline. But nearly 68% believe there should be no federal guideline for opioid medication.

“Physicians should be able to manage their patients’ pain without fear of agencies monitoring and implementing guidelines that limit their ability to properly manage and treat and individuals pain. Chronic pain and acute pain is individually subjective and no ONE agency should be able to determine how or what manages an individuals pain,” a provider wrote.

“These guidelines are an unmitigated disaster for the last 5 plus years and those responsible for creating the mess should be held accountable for the damage they created and continue to create. How many suicides? How many overdoses from turning to the ‘street’ for relief from pain? How in hell did the CDC become the authority?” asked one patient.

Nine out of ten patients said their pain levels and quality have life have grown worse since the CDC guideline was released. For further details, click here.

(The PNN survey was conducted online and through social media from March 15 to April 17. A total of 4,185 people in the United States participated, including 3,926 who identified themselves as chronic, acute or intractable pain patients; 92 doctors or healthcare providers; and 167 people who said they were a caretaker, spouse, loved one or friend of a patient. There were no significant differences in responses between the three groups. Thanks to everyone who participated in this valuable survey. To see the full survey findings, click here.)

Study Debunks Theory About Rx Opioids Leading to Heroin Use

By Pat Anson, PNN Editor

Anti-opioid activists have long claimed that opioid pain medication is a gateway drug to heroin, often citing a 2013 study that found about 80% of heroin users had first misused prescription opioids. The gateway drug theory soon became doctrine in the national debate over opioids.

“The connection between prescription opioid abuse and heroin use is clear, with 80% of new heroin abusers starting their opioid addiction by misusing prescription medications,” the DEA claims.

The 80% figure sounds alarming, but it is misleading. Only about 5% of people who misuse opioid medication switch to heroin, according to the National Institute of Drug Abuse. The vast majority of people who use prescription opioids responsibly never try street drugs.

A new study of heroin users in Oregon, published in the Journal of Addiction Medicine, adds some much needed context to the claim that prescription opioids are gateway drugs.

Researchers looked at a database of over 10,000 people being treated for opioid use disorder, and identified 624 individuals who started using heroin between 2015 and 2017. About half (49%) had filled a prescription for opioids in the year before heroin initiation.

Forty-nine percent having a valid opioid prescription might seem alarming too, until you look at what else the new heroin users had in common. Compared to a control group, many were already showing signs of diversion and substance abuse. They were more likely to have multiple prescribers and pharmacies, and to have prescriptions for other controlled substances, such as benzodiazepines and buprenorphine (Suboxone).

Importantly, 41% had stopped using opioid medication prior to their use of heroin; only 13% had an opioid prescription longer than 90 days; and only 7% were on high daily doses of 90 MME (morphine milligram equivalent) or more – which was about the same as the control group. This suggests that pain medication plays only a minor role, if any, on the path to heroin.

“To our knowledge, this is the first study to quantify patterns of prescription opioid (use) preceding self-reported heroin initiation,” wrote lead author Daniel Hartung, PharmD, an Associate Professor of Pharmacy at Oregon State University. “Although prescription opioid use commonly preceded self-reported heroin initiation, long-term opioid therapy was not common.”

“The take home message for me is that, in contrast to what has been purported by some individuals, the use of long-term opioids does not increase risk of using heroin,” says Dr. Lynn Webster, a PNN columnist and past president of the American Academy of Pain Medicine. “They also report that doses above 90 MME did not increase the risk of using heroin.

“This study underscores that prescription opioids are not a gateway to heroin use. The use of prescription opioids is less of a factor that leads to any drug abuse than the genetics and environment of the person who abuses opioids.” 

Hartung and his colleagues cautioned that the gateway drug theory should not be used to forcibly taper patients off opioid medication, which might lead to “unintended harms” such as overdoses.

“Although the harms of long-term opioid therapy are well-described, emerging evidence is beginning to suggest risks associated with discontinuation or disruption of long-term therapy,” they said. “There remains an urgent need to identify factors that predict transition to heroin as well as delineate the adverse sequelae of rapid or forced de-escalation of chronic opioid therapy.”

Few Patients on Long-Term Opioids Engage in Risky Behavior

By Pat Anson, PNN Editor

Only a small percentage of pain patients on long-term opioid therapy ask for higher doses, renew their prescriptions early or divert their medication to another person, according to a new study that challenges many common assumptions about prescription opioids.

For five years, Australian researchers followed over 1,500 patients taking opioid pain medication, with annual interviews asking them about their opioid use and behavior. The study is believed to be the first of its kind to follow patients on opioid therapy for such a long period.   

Most of the patients suffered from chronic back, neck or arthritis pain, and were taking opioids for at least 6 weeks at the start of the study, including about 15% who were taking high doses exceeding 200 MME (morphine milligram equivalent) per day. The CDC opioid guideline recommends that daily doses not exceed 90 MME.  

Researchers found that “problematic opioid use” was infrequent and steadily declined over time, with less than 10% of patients asking for higher doses or for a prescription to be renewed early. Less than 5% of patients tampered with their medications or diverted them to another person.     

“Contrary to the predominant thinking in pain management, the findings of this study suggest considerable fluidity in opioid use over time among many patients with CNCP (chronic non-cancer pain) who use opioids,” wrote lead author Louisa Degenhardt, PhD, Deputy Director of the National Drug and Alcohol Research Centre at University of New South Wales.

By the end of the study, patients were more likely to have stopped taking opioids (20%) than they were to be diagnosed with opioid dependence (8%), suggesting that long-term opioid use does not always lead to dependence or addiction. Even when they were diagnosed as opioid dependent, most patients did not meet the criteria for dependence the following year, suggesting the original diagnosis was faulty.

JAMA Network Open

Researchers noted there was “substantial variation” in how patients answered questions from year to year about their opioid use and behavior. Most who reported risky behavior did so in only one of the annual interviews.  

“This finding challenges a common view that the risk of opioid-related behaviors is static and that risk assessment at the start of opioid treatment can predict which patients will develop opioid use disorder,” researchers concluded in JAMA Network Open. “By contrast, individuals who engage in opioid-related behaviors change over time, which also suggests that opioid behaviors of concern need not persist.”

“This study shows what most clinicians treating CNCP with opioids already know, which is that most individuals do fine with chronic opioid therapy. It is only a few people who develop a problem, and that can’t be easily predicted based on a person's early behaviors associated with opioids prescribed for pain,” said Dr. Lynn Webster, a PNN columnist and past president of the American Academy of Pain Medicine.

“It refutes the argument that patients on chronic opioid therapy inevitably will abuse, become addicted, or never cease using opioids once started.” 

Webster noted that most people in the study were stable and few demonstrated any abuse or harm from opioids, including those on high doses who were less likely to ask for more medication.

“I think the overriding message of this study is that the one-size-fits all approach to using opioids for CNCP is flawed. The idea that everyone should be at a low level doesn't address individual needs,” Webster said.

No Relationship Between Rx Opioids and Injury Deaths

Another new study that challenges conventional thinking about prescription opioids found that high doses are not associated with higher rates of trauma-related death.

Researchers at Case Western Reserve University looked at mortality rates in all 50 states from 2006 to 2017, comparing them to the amount of opioids prescribed during the same period.

The researchers believed they would find a relationship between opioids and higher death rates. Their theory was that people on opioids were more likely to be impaired, which would lead to more car crashes, accidents, drownings, suicides and other types of trauma death.

But in findings reported in the journal Injury, there was no association between the two.

“In every state examined, there was no consistent relationship between the amount of prescription opioids delivered and total injury-related mortality or any subgroups, suggesting that there is not a direct association between prescription opioids and injury-related mortality,” wrote lead author Esther Tseng, MD, a trauma surgeon and professor at CWRU.

It's important to note that Tseng and her colleagues did not look at fatal overdoses caused by prescription opioids. Previous research by the CDC has found that deaths linked to opioid pain medication have been relatively flat for nearly a decade. The vast majority of overdoses involve illicit fentanyl and other street drugs.    

UK Guidelines Recommend Exercise and Antidepressants for Chronic Pain

By Pat Anson, PNN Editor

Doctors in the United Kingdom are being advised not to prescribe any type of painkiller to patients suffering from fibromyalgia, chronic headache, Complex Regional Pain Syndrome (CRPS), chronic musculoskeletal pain and other types of “primary chronic pain” for which there is no known cause.   

Those conditions should be treated with exercise, cognitive behavioral therapy (CBT), acupuncture and antidepressants, according to new guidelines released by the UK’s National Institute for Health and Care Excellence (NICE). The NICE guideline is far more strict on the use of analgesics than current treatment guidelines in the U.S. and Canada.

The recommendation against using painkillers goes beyond just opioids, and includes many widely used pain relievers such as paracetamol (acetaminophen), non-steroidal anti-inflammatory drugs (NSAIDs), gabapentinoids and corticosteroids, as well as benzodiazepines such as Valium and Xanax.

“There is little or no evidence that they make any difference to people’s quality of life, pain or psychological distress, but they can cause harm, including possible addiction,” NICE said in a statement.

The guideline says antidepressants such as duloxetine (Cymbalta) and fluoxetine (Prozac) “can be considered” for adults 18 and over with chronic primary pain, even when there is no diagnosis of depression. NICE said antidepressants may help with quality of life, pain, sleep and psychological distress.

“This guideline is very clear in highlighting that, based on the evidence, for most people it’s unlikely that any drug treatments for chronic primary pain, other than antidepressants, provide an adequate balance between any benefits they might provide and the risks associated with them,” Dr. Paul Chrisp, director of NICE’s Centre for Guidelines, said in a statement.

“People who are taking medicines to treat their chronic primary pain which aren’t recommended in the guideline should ask their doctor to review their prescribing as part of shared decision making. This could involve agreeing a plan to carry on taking their medicines if they provide benefit at a safe dose and few harms, or support for them to reduce and stop the medicine if possible.”

The NICE guideline sticks to more traditional recommendations for treating “chronic secondary pain” for which there is a known underlying cause, such as osteoarthritis, rheumatoid arthritis, ulcerative colitis and endometriosis. Pain management for palliative care is not covered in the guideline.

‘Patently Ridiculous’

Although a draft version of the NICE guideline was released last August, pain sufferers were startled by some of the final recommendations, especially those for acupuncture, CBT and exercise.

“The idea that a run around the block will zap the torment of people in chronic pain is patently ridiculous. It doesn’t do a damned thing for my hip,” said James Moore, a UK disability activist who uses a wheelchair. “Did none of the people who contributed to this not read it through this guidance and spot any of the gaping holes in its logic? How is it that I can see them and they can’t?”

“I fear the consequences for those with unsympathetic GPs who suddenly find themselves without medication that may work for them,” Moore wrote in the Independent. “This guidance urgently needs a rethink. Sadly, there may be torture looming for those in torment before we get one.”

The NICE guideline is at odds with recent studies that found antidepressants are minimally effective as pain relievers and often have adverse side effects. A common complaint of pain patients who take duloxetine, for example, is how quickly they became dependent on the drug and have severe withdrawal symptoms when they stop taking it.

The UK guideline also differs from treatment recommendations made by U.S. health agencies. The FDA and CDC recommend gabapentinoids for fibromyalgia, and acetaminophen and NSAIDs for low back pain and migraine.   

The CDC is currently in the process of updating and possibly expanding its opioid guideline to include recommendations for opioid tapering, short-term acute pain, migraine and other pain conditions. 

Study Finds Little Evidence to Support Use of Acetaminophen

By Pat Anson, PNN Editor

Acetaminophen is the most widely used over-the-counter pain reliever in the world — the active ingredient in Tylenol, Excedrin, and hundreds of pain medications. The U.S. Centers for Disease Control and Prevention considers acetaminophen a “first-line” treatment for low back pain, osteoarthritis and migraine.

But a comprehensive review published in the Medical Journal of Australia found little or no evidence to support the use acetaminophen for most pain conditions. Researchers at the University of Sydney analyzed 36 studies involving over 19,000 people and concluded that the pain-relieving benefits of acetaminophen – known as paracetamol outside the U.S. -- are modest, at best.

“For most conditions, evidence regarding the effectiveness of paracetamol is insufficient for drawing firm conclusions. Evidence for its efficacy in four conditions was moderate to strong, and there is strong evidence that paracetamol is not effective for reducing acute low back pain,” wrote senior author Christopher Maher, PhD, a professor at the Sydney School of Public Health.

Maher and his colleagues looked at 44 pain conditions often treated with paracetamol, and could find only four for which there is high-quality evidence:

• Knee and hip osteoarthritis

• Tension headache

• Perineal pain after childbirth

• Craniotomy

Evidence for the other 40 pain conditions was low quality or inconclusive, including:

• Acute and chronic low back pain

• Major surgery

• Dental surgery

• Migraine

• Rheumatoid arthritis

• Hip fracture

• Cancer pain

• Neuropathic pain

“While paracetamol is widely used, its efficacy in relieving pain has been established for only a handful of conditions, and its benefits are often modest. Although some trials have evaluated regimens that may have underestimated its utility, the clinical application of paracetamol is primarily guided by low quality evidence, at best,” researchers said.  

A 2015 study in the British Medical Journal also found that paracetamol was ineffective for low back pain and provided little benefit to people with osteoarthritis.

In recent years, some U.S. hospitals have started using paracetamol as an alternative to opioids for post-operative pain, a practice not supported by the Australian study.

One limitation of the University of Sydney review is that most of the studies that were evaluated only used a single dose of paracetamol, which does not reflect its typical use.  Perhaps for that reason, researchers found that adverse events were similar for patients receiving paracetamol or a placebo.

Over 50 million Americans use paracetamol (acetaminophen) each week to treat pain and fever. Long-term use has long been associated with liver, kidney, heart and blood pressure problems. Acetaminophen overdoses are involved in about 500 deaths and over 50,000 emergency room visits in the U.S. annually.

CDC Won’t Say Who Is Writing Update of Opioid Guideline

By Pat Anson, PNN Editor

When the Centers for Disease Control and Prevention released the draft version of its opioid prescribing guideline in September 2015, the agency was roundly criticized for its secrecy and lack of transparency.

There were no public hearings. The CDC initially refused to identify who wrote the guideline or who its advisors were. And the public was given just 48 hours to comment on the guideline after a botched online webinar that presented only a summary of the recommendations.     

After a congressional investigation and threats of a lawsuit for “blatant violations” of federal laws, the CDC changed course and opened up the guideline to public scrutiny and a 30-day comment period. After a few minor changes, the guideline was released in March 2016.

Five years later, after a tsunami of complaints that the guideline’s recommended dosage limits have been harmful to patients and failed to reduce opioid addiction and overdoses, the CDC is now in the process of rewriting the guideline.

There’s more transparency this time around. The public was given an early invitation to comment and nearly 5,400 people wrote to the CDC about their concerns.  The agency also released the names of the “Opioid Workgroup,” a diverse group of physicians, academics and patients that is advising the agency as it updates the guideline.     

But one thing hasn’t changed: the CDC won’t identify who is writing the guideline update.

“Primarily CDC scientists are involved in drafting the update,” Courtney Lenard, a CDC spokesperson, explained in an email to PNN. “Many CDC staff are working on the process of updating the 2016 Guideline, including reviewing the scientific evidence; analyzing patient, caregiver, and provider input gathered during the public comment period and conversations held earlier in 2020; and drafting its content.”

The updated guideline will be only reviewed by the Opioid Workgroup, which has been given no direct role in writing it or in making revisions. The workgroup is expected to give its recommendations to the Board of Scientific Counselors at the CDC’s National Center for Injury Prevention and Control sometime this summer.

“At that time the authors of the draft Guideline will also be announced,” said Lenard, adding that the public likely won’t see the draft until late 2021, when it is published in the Federal Register.

Potential Conflicts of Interest

Only after another round of public comments will the revised guideline finally be released in 2022 – a full six years after the initial guideline. Some patient advocates worry about a lack of urgency at CDC and that too much is occurring behind closed doors.  

“I remain concerned about an ongoing lack of transparency in the development of an update to the CDC Pain Guidelines,” said Dr. Chad Kollas, a palliative care specialist in Florida. “There will be no disclosure about the authorship of the revised guidelines until their release, which effectively eliminates the opportunity to challenge any of their authors’ potential conflicts of interest proactively.”

“The CDC has put together a writing team without addressing transparency or conflicts of interest to our satisfaction,” says Terri Lewis, PhD, a patient advocate and researcher. “This is unacceptable and nonresponsive to the concerns that have been so clearly expressed by both the patient community and the medical communities since 2016.”  

The CDC’s evasive response about who is writing the update raises the possibility that the three authors of the original 2016 guideline are working on the revision: Deborah Dowell, MD; Tamara Haegerich, PhD; and Roger Chou, MD.

In 2019, the trio penned an awkward defense of the guideline in The New England Journal of Medicine, in which they admitted the “misapplication” of guideline was causing harm to patients, but deflected taking any responsibility for it.

Chou’s involvement in the updated guideline would be particularly alarming to critics, because of his advocacy for opioid tapering and collaboration with Physicians for Responsible Opioid Prescribing (PROP), an anti-opioid activist group.

“I'd give long odds that Roger Chou is a member of the current CDC writers group,” says Richard Lawhern, PhD, a prominent advocate in the pain community. “Talk about giving the fox the keys to the hen house!” 

In addition to his work on the 2016 guideline, Chou has authored numerous articles on pain management in peer-reviewed medical journals, many of them critical of opioid prescribing.

Chou is listed as an “external reviewer” on a PROP guide promoting “Cautious, Evidence-Based Opioid Prescribing” that at one time was posted — unedited — on the CDC’s website.

In 2019, Chou co-authored an article with PROP President Dr. Jane Ballantyne and PROP board member Dr. Anna Lembke that encourages doctors to consider tapering “every patient receiving long term opioid therapy.”

And in 2011, Chou co-authored another op/ed with PROP founder Dr. Andrew Kolodny and PROP vice-president Dr. Michael Von Korff, calling for a major overhaul of opioid guidelines, which were then primarily written by pain management specialists.

“Guidelines for long-term opioid therapy should not be developed by the field of pain medicine alone. Rather, experts from general medicine, addiction medicine, and pain medicine should jointly reconsider how to increase the margin of safety,” Chou and his co-authors wrote, a call to action that came to pass five years later at CDC with a guideline that he helped write.

“I do not believe the CDC should be writing opioid guidelines,” says Dr. Lynn Webster, a PNN columnist and past president of the American Academy of Pain Medicine.  

“The authors of the CDC guideline should not have been tasked with creating the guideline for a few reasons. First, this was outside their areas of expertise. Second, they failed to understand how misguided arbitrary limits of morphine milligram equivalents were in recommending dosing to people in pain. Third, they lacked compassion for people in pain and an understanding that, for some patients, opioids were the only effective, available treatment.”  

Should Chou Be Recused? 

Chou is a primary care physician who heads research at the Pacific Northwest Evidence-based Practice Center at Oregon Health & Science University. He was the lead investigator for a recent report by the Agency for Healthcare Research and Quality (AHRQ) that found opioids have only “small beneficial effects” when prescribed for chronic pain and “do not appear to be superior to nonopioid therapy.”

Chou’s report, along with four other AHRQ reviews of pain therapies, were commissioned by the CDC. The reports are being used as key resources by the agency as it updates and possibly expands the opioid guideline to include recommendations for opioid tapering, short-term acute pain, migraine and other pain conditions. 

Some advocates believe Chou is so biased against opioids he should be recused from any further work on the guideline.

“I agree with that. He’s clearly published things and said things. He is not objective on dealing with people who need high dose opioids. It’s just as simple as that. He’s going to oppose anything that allows people to take opioid drugs,” says Forest Tennant, a PNN columnist and intractable pain expert. “They never put people on there who are for opioids. It’s always against.”

“Absolutely he should (be recused). Dr Chou is in the position of being given an opportunity to defend his earlier misdirected, unscientific, and ethically unsound work by influencing the revised guidelines to confirm his earlier positions. This is a ‘professional’ self-interest at least equally as meaningful of any financial relationship,” said Lawhern. 

“The harm the 2016 guideline caused should be sufficient reason to find a new group of individuals to work on the updated recommendations. Having the same authors work on the same guidelines makes it almost inevitable that the same mistakes will be made,” says Webster.

“To paraphrase Albert Einstein, it is insanity to do the same thing again and expect different results. If you want better results, you have to do something differently. I can see that the updated guideline will lack consideration for patients as individuals, just as the 2016 guideline did.”

For much of the past year, the CDC has been preoccupied dealing with fallout from the COVID-19 pandemic. The agency’s once-sterling reputation has been damaged by political interference and shifting recommendations on how to control the virus. The agency’s focus in 2021 is likely to remain on COVID-19.

Pain sufferers and their advocates worry that revising the opioid guideline will not be a top priority at CDC, and that many of the same mistakes made five years ago are being repeated.    

“There is no indication that CDC is treating this with the respect it deserves or with the scientific rigor it demands in spite of mounting evidence that the management of prescription opioids in the USA is 'going off the rails' and that very real systemic and structural harms are accruing to patients and the health care delivery system in general,” says Terri Lewis. 

“I think it fair to say that we all fear that, based on what we are aware of at the moment, this next round of 'revision' will simply amount to an 'expansion' into territory for which there is almost no verifiable evidence and very weak support in the existing literature.”

The Unintended Consequences of the CDC Opioid Guideline

By Dr. Lynn Webster, PNN Columnist

Jack Schwartz (a pseudonym) is a child of Holocaust survivors. As a small boy, he was traumatized by observing his older brother become addicted to heroin. He also developed a substance use disorder of his own that he believes was due, in part, to childhood PTSD.

A 64-year-old psychotherapist, Schwartz has been in chronic pain since a 1996 car accident injured his neck. Although he has a history of substance use disorder, he has used opioids to manage his pain for the past several years.

His personal physician, who retired at the end of 2020, wrote a letter stating Schwartz has been prescribed Norco (a combination of acetaminophen and hydrocodone), has been compliant, and has shown no signs of abuse for the previous four years. The retiring doctor hoped Schwartz would be able to find someone to continue prescribing his Norco.

Schwartz has not yet found a new physician. In the meantime, his insurance company notified him that they would not pay for his medication, citing the CDC’s opioid prescribing guideline and their own opioid policy, which states that "narcotics are not the treatment of choice for chronic nonmalignant pain."

Schwartz contacted me after reading a PNN column I wrote, "Ironic Partners: Suicide Prevention and Pain Awareness Month." He said he was suicidal and asked me for advice. We agreed that sharing his story might help others in similar positions.

Who Should Write Clinical Guidelines?

Regrettably, Schwartz’s situation is not uncommon. Many insurers and regulators have adopted rigid policies that cite the CDC’s voluntary guideline as if it was the standard of care. The CDC has admitted its guideline is being misapplied and is working on an update, but so far the agency has done little to correct the problem.

In fact, the CDC has gone even further than the guideline, producing a fact sheet for physicians, “Nonopioid Treatments for Chronic Pain,” in which it recommends alternative medications for common chronic pain conditions including migraine, low back pain, osteoarthritis, fibromyalgia, and neuropathic pain.

Why is the CDC making medical treatment recommendations?

Cardiologists and heart surgeons should develop recommendations for managing heart disease. Endocrinologists should offer recommendations for managing diabetes. Infectious disease specialists should make recommendations for managing infections. Addiction specialists should provide recommendations for treating addiction. And it is pain specialists who should develop treatment guidelines for treating pain.

The way it should work is this: Professional organizations representing medical specialties develop treatment guidelines. Whenever possible, input should be solicited from patient stakeholders. The role of government organizations such as the National Institutes of Health, FDA, CDC, and DEA should be to provide data and resources to these groups, so they can initiate and revise treatment guidelines as the science evolves.

Specialists should lead the way to ensure patient care is clinically driven and patient-centered. Non-clinicians, such as government officials — even if they have medical degrees— should not be making treatment decisions or creating guidelines for specialists and their patients.

Walking Back the CDC Guideline

In my view, it was a mistake for the CDC to release the guideline in 2016. Before it was published, I predicted people in pain would suffer and that the guideline would not reduce the number of opioid-related overdose deaths. Unfortunately, I was correct.

Many providers, patients and their loved ones have urged the CDC to revise or withdraw the guideline. The American Medical Association has urged the CDC to make "significant revisions."  

The three co-authors of the guideline, Deborah Dowell, MD, Tamara Haegerich, PhD, and Roger Chou, MD, even wrote a commentary for The New England Journal of Medicine in 2019 acknowledging that their recommendations were being misapplied and were “likely to result in harm to patients.”

The admission that the CDC guideline was harmful was long overdue. Now the question of how the recommendations should be changed must be addressed. Hopefully, the CDC will consider input from people who have been harmed the most by the guideline and will revise their recommendations accordingly.

Jack Schwartz continues to struggle with intractable pain and suicidal feelings. He, and millions of people like him, need for your opinion and your provider’s perspective, to be heard. Maybe then more rational decisions will be made regarding the use of opioids for the treatment of pain.

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

Kolodny: Critics of CDC Opioid Guideline ‘Twisting the Facts’

By Pat Anson, PNN Editor

The founder of the anti-opioid activist group Physicians for Responsible Opioid Prescribing (PROP) says his organization played only a minor role in drafting the CDC opioid guideline and claims much of the controversy over the guideline was stirred up by pain organizations funded by the pharmaceutical industry.

“Not every group that has harmful advocacy is funded by industry, but the vast majority are. The ones that are not funded by industry work arm-in-arm with industry funded groups,” said Dr. Andrew Kolodny. “They have an agenda. A lot of individuals, journalists, organizations that have weighed in on the opioid crisis have an agenda. And they will try and twist the facts to fit their agenda.”

Kolodny spoke for over an hour Tuesday during a webinar hosted by PharmedOut, a program at Georgetown University that seeks to expose deceptive marketing in healthcare. The webinar was billed as an effort to refute “False Narratives & Manufactured Controversies about the Opioid Crisis,” but it turned into a rambling dialogue by Kolodny that gaslighted pain sufferers, doctors, patient advocates and anyone else critical of the CDC guideline.

“Much of the controversy or the critique of the guideline, almost all of it, was focused on the secretive way in which the guideline had been drafted, not on the actual recommendations. They seemed to stay clear from attacking recommendations, almost all of which were pretty benign,” said Kolodny.

Although voluntary and only intended for primary care physicians, the CDC guideline has become the “standard of care” in the United States for treating pain, with millions of patients taken off opioids or reduced to lower doses in the name of preventing addiction and overdoses.

Many patients say their pain and quality of life are now significantly worse, they have a hard time finding doctors, and some have turned to alcohol and illegal drugs for pain relief. The opioid crisis also continues to grow worse, with a record number of fatal overdoses last year – most of them caused by illicit fentanyl and other street drugs, not prescription opioids.

Even the CDC has recognized that its 2016 guideline has caused “unintended harms,” and the agency is now in the process of updating and possibly expanding its recommendations.

Kolodny brushed aside many of those concerns and instead focused on deflecting attention away from PROP –- at various times blaming Purdue Pharma, the Koch brothers and the Washington Legal Foundation for “manufacturing a controversy around the CDC recommendations.”

“To try and make the guideline controversial, the messaging came out that the guideline has been secretly written by PROP. We started to see mentions in social media and publications describing PROP as a fringe group or as anti-opioid zealots. So the messaging was that the CDC relied on this fringe, anti-opioid zealot group to secretly write the guideline,” Kolodny said. 

As PNN has reported, the CDC guideline was in fact drafted in secret, with no public hearings and little input from patients or pain management experts. Only when threatened with a lawsuit by the Washington Legal Foundation and a congressional investigation did the CDC open up the guideline process to public scrutiny and disclose the identities of its advisors and consultants.

At least five PROP board members were involved in drafting the guideline, although Kolodny claimed there were only three in Tuesday’s webinar.  PROP President Jane Ballantyne and Vice-President Gary Franklin were members of a key advisory panel; David Tauben was on the guideline’s peer review panel; and Kolodny and David Juurlink were on a stakeholder review group.

While technically true that PROP did not write the guideline, PROP had input and key relationships within the CDC. Dr. Roger Chou, one of the guideline authors, has collaborated with PROP members on several occasions, such as writing an op/ed with Ballantyne that encouraged doctors to consider tapering “every patient receiving long term opioid therapy.”

Koldony is also a longtime associate and friend of then CDC Director Thomas Frieden, and has co-authored op/eds with Frieden, including one that recommended taking all high-dose opioid medications off the market.

We may never know the true extent of these relationships, because CDC has refused to disclose key material about its guideline deliberations. The agency’s response to a Freedom of Information Act (FOIA) request from PNN was to send us nearly 1,500 pages of documents that were heavily redacted or scrubbed of information. Over 1,200 pages were completely blank.

The agency cited “deliberative process privilege” and “personal privacy” as reasons to withhold the information.

Friendly Questions

Kolodny took only a handful of friendly, softball questions during the webinar, most of them from students at Georgetown University who are interning at PharmedOut. Several pain patients also submitted more critical questions, but they were not passed on to Kolodny.

Although opioid prescriptions in the U.S. have been declining since their peak in 2011, Kolodny says they need to go down further, even though nearly 85% of overdose deaths in the U.S. involve illicit fentanyl and other street drugs.

“We continue to massively overprescribe,” he said. “Opioids are not good treatments for chronic pain. It’s not true that more cautious prescribing somehow jeopardizes compassionate care for chronic pain. Compassionate care for chronic pain really demands more cautious prescribing.”

Kolodny is quick to blame “industry funded groups” for opposition to the CDC guideline, but PROP has remained secretive about its own funding. PROP uses a loophole in IRS regulations that allows it to hide behind front organizations such as the Steve Rummler Hope Network as its “fiscal sponsor.” Because it is not registered as a nonprofit — although it sometimes claims to be one — PROP has never filed a federal or state tax return and is not required to disclose anything about its funding or spending.

Kolodny currently works in opioid research at Brandeis University, but has a lucrative sideline testifying as an expert witness in opioid litigation and malpractice lawsuits. He was paid $725 an hour for his testimony during Oklahoma’s lawsuit against Johnson & Johnson, and may have collected as much as $500,000 for that case alone.

Dr. Adriane Fugh-Berman, who is a PROP board member and Director of PharmedOut, is also a paid expert witness and earned $500 an hour for her testimony in another trial involving Johnson & Johnson. She reportedly received about $120,000 for her work in that case. Like PROP, PharmedOut does not disclose its funding or donors.

DEA: Drug Cartels Targeting Pain Patients as Potential Customers

By Pat Anson, PNN Editor

The Drug Enforcement Administration’s “National Drug Threat Assessment” is an interesting annual report that gives insight into drug trafficking and drug abuse trends in the United States that you don’t often see in the mainstream media..

The DEA’s 2020 report, released this month, is no exception. One hundred pages long, it covers a broad range of “unclassified” information about drug cartels, counterfeit medication and emerging trends in drug abuse.

“Although we have made progress in driving down the abuse of controlled prescription opioids, the United States continues to face challenges from both new and persistent threats,” said acting DEA Administrator Christopher Evans.

According to the DEA report, the diversion and abuse of opioid painkillers and other controlled prescription drugs (CPDs) are at their “lowest levels in nine years.”

While opioid pain relievers remain the most commonly abused type of prescription drug, most people don’t take them to get high.

The DEA said nearly two-thirds (64%) of drug users “identified relieving pain as the main purpose” for their misuse of painkillers – a staggering statistic that may say more about the poor state of pain care in the U.S. than anything else.

Ironically, the second most widely abused opioid medication was buprenorphine, which is combined with naloxone in addiction treatment drugs such as Suboxone and Zubsolv. The National Forensic Laboratory (NFLIS) reports that buprenorphine is abused far more often than methadone or hydrocodone, and appears poised to soon replace oxycodone as the most commonly abused prescription opioid. 

“Drug data reveals that buprenorphine reports from all participating federal, state, and local laboratories increased each year except a minor drop from 2018 to 2019. (NFLIS) reported a 50 to 67 percent decrease of hydrocodone, methadone, and oxycodone reports from 2014 to 2019, so the 27 percent increase of buprenorphine during that time frame was significant,” DEA said.     

Fentanyl Laced Counterfeit Pills

Not surprisingly, the DEA said illicit fentanyl was “primarily responsible for fueling the ongoing opioid crisis,” with Mexican drug cartels controlling most of the supply for the potent synthetic opioid. With hydrocodone, oxycodone and other legal opioid medications in short supply — and a lot of people with poorly treated pain — the DEA believes drug cartels are actively targeting pain sufferers as potential customers for counterfeit medication.

“The spread of fentanyl-laced counterfeit pills in the United States is likely due to Mexican TCOs (Transnational Criminal Organizations) seeking to further distribute fentanyl into prescription opioid user populations,” the DEA said. “The increasing number of counterfeit pills resembling prescription medications and users who may be pivoting to abusing illicit substances with waning CPD availability may prove to be a significant threat into 2021.”  

The counterfeit pill of choice for the drug cartels are fake 30mg oxycodone tablets, stamped with an “M” on one side and “30” on the other.

Known on the street as “Mexican Oxy” or “M30s,” the DEA says the blue tablets “demonstrate that traffickers are taking advantage of an established market for these pills.”

Illicit fentanyl tablets appear to be getting more lethal, with laboratory tests showing 26 percent of them containing a potentially fatal dose of fentanyl in 2019, compared to just 10 percent in 2017.

In one chilling paragraph, the DEA seemed to acknowledge it was losing the war on drugs to Mexican cartels and local criminal gangs.

“Barring significant, unanticipated changes to the illicit drug market, Mexican TCOs will continue to dominate the wholesale importation and distribution of cocaine, heroin, marijuana, methamphetamine, and fentanyl in U.S. markets. No other criminal organizations currently possess a logistical infrastructure to rival that of Mexican TCOs. Mexican TCOs will continue to grow in the United States through expansion of distribution networks and continued interaction with local criminal groups and gangs,” the agency warned.

Sometimes what is not disclosed in the DEA’s report is just as revealing as what is actually said. For example, while the DEA officially lists kratom as a “drug of concern” and even tried to ban the herbal supplement in 2016, the agency has never said a word about kratom in its annual threat assessment. Not in 2020. Not ever.  

Why is that? Is kratom not addictive or dangerous, despite all the public hand-wringing over the years by the Food and Drug Administration? In a 2018 letter to the DEA recently made public, federal health officials quietly withdrew their request to schedule kratom as a controlled substance because of “lack of evidence” it can be abused or posed a public health threat.

How You Can Change the Public Conversation About Pain

By Richard Lawhern, PhD, PNN Contributor

Because I am highly visible as a healthcare writer and advocate for people in pain, I receive many inquiries from people who have been deserted by their doctors and denied effective treatment.  Many ask me, “What can I do?” 

My answer is that many of our problems with pain treatment began with the guideline on opioid prescribing for chronic non-cancer pain, published in 2016 by the U.S. Centers for Disease Control and Prevention. The CDC is currently updating its recommendations, with the goal of releasing a revised guideline for public comment late this year. Without major change or outright repeal of the guideline, nothing will change and much may grow worse.

CDC management knows that they messed up -- they’ve been told so repeatedly over the last five years by both doctors and patients.  But still they dither and delay, and refuse to act on behalf of millions they have harmed.

Congress has added insult to injury with misdirected legislation blaming doctors for the substance abuse of people who never saw a doctor for pain.  And the Drug Enforcement Administration continues to drive doctors out of pain practice by targeting and persecuting those who prescribe opioid medication for people in agony.   

We can no longer depend on the CDC and DEA to do the right thing. They are too concerned with defending their earlier and ongoing misbehavior.  Instead, we’re going to have to change a lot of minds in Congress, the Executive Branch, and at the state level to force change by legislation. Thousands of patients, caregivers and doctors must lobby if change is to happen.  

How Do We Lobby Effectively? 

We don’t have the money to hire lobbyists. Law firms won’t sue without millions of dollars in retainers up front.  Most legislators don’t actually read emails, even from their own constituents, and increasingly they lock out emails from anyone who doesn’t vote in their districts. Petitions don’t work either, even when we have 100,000 signatures behind them.   

So what can we do? We can phone our legislators to demand change, and we can reach out to editors, publishers, radio and TV news anchors to ask that they show the public “the other side” of the opioid crisis.

It may seem that one person acting alone can’t do much.  But thousands of people acting consistently sometimes can.  We need patients, caregivers and medical professionals to contact their legislators and regulators.  Not just once, but every week.  Your congressional representatives in the U.S. House and Senate, as well as state legislators, can all be candidates for a phone call.  

To learn their names, first do a Google search for “legislators” plus your zip code. You might need to explore several “hits” to find the phone numbers for local congressional offices and the offices of your state legislators. Other possible contacts to explore:  

• U.S. National Office of Drug Control Policy 

• Office of the Governor  

• State Health Department

• Executive Director of your State Medical Board 

• State office of the Drug Enforcement Administration 

• State Attorney General 

Two important websites may reduce the burden of multiple Google searches to locate these people. The Chronic Illness Advocacy & Awareness Group (CIAAG) has links to a national directory of legislators and regulators by state; a library of resources and research; “How to” advocacy guides; and templates for calling and meeting with legislators. Similar resources can be found at Pain Warriors Unite, which also has a large archive of related information and advocacy guides.  

What Should We Tell Them?

When you locate the phone numbers of legislators and regulators, the next task is to phone their offices and talk to them or their staff. 

When you call, you might find that the office isn’t answering their phones.  If you can leave a message, then state your name and callback number. Tell them you are a voter in their state or district, and you want to talk with their healthcare policy staffer about how bad policy and restrictions on pain treatment are destroying your life. Hang up politely.

If you reach anyone in real time, it will almost always be a staffer.  As you speak, try to listen for their responses and be respectful.  Here is a possible script.  Practice it aloud before you make your calls, so you are comfortable with what you want to say: 

“Good morning” (or Good afternoon). My name is ___________ and I vote in ______ (State or District number).

“May I ask your name, please?”   [Make a note for later follow-up]

“I’ve been a chronic pain patient for __ years and under doctor’s care for several complex pain issues.  Right now, my life is a wreck because doctors have been terrorized by government authorities. Nearly half of primary care clinics in the U.S. are refusing to accept new patients on opioid pain relievers, even though pain is the number one reason why people see a doctor.  Many practices that still treat pain are rapidly force-tapering patients off opioids, or below effective treatment levels.”

You should include some personal details about what your life is like without adequate pain management. An example might be:

“I literally cannot get out of bed many days, because I am in agony from under-treatment of my pain. I can’t work, do simple chores, or leave the house for basic necessities without help. 

The so-called ‘prescription opioid crisis’ is bogus.  Doctors prescribing opioids for their patients didn’t create our public health crisis with addiction and overdose deaths. Pain patients almost never become addicted. For millions of us, opioids are the only thing that gives us any quality of life.”

End with a call for action. Ask them to do something with the information you give them.

“People like me need your boss to sponsor legislation to fix this mess.  We need him (her) to help stop the widespread persecution of doctors who prescribe medical opioids for people like me.

Restrictions on access to effective pain care are driving thousands of us to buy street drugs for relief or to even consider suicide. If your boss doesn’t act to stop this disaster, then he (she) will become an accessory to it.”

End the call by asking the staffer to add notes from the call to their office phone logs, and to brief the office Chief of Staff or legislator. Ask for a call-back from that individual, confirming that they got the message and are working on your behalf. Be sure to leave a call-back number if they don’t ask for one.

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. Dr. Lawhern has written or co-authored over 100 papers and articles published in medical journals and mass media.

How Should the CDC Opioid Guideline Be Changed?

By Pat Anson, PNN Editor

It was five years ago today – March 15, 2016 – that the Centers for Disease Control and Prevention released its controversial opioid guideline, which discourages doctors from prescribing opioids for chronic pain.   

“This guideline is intended to improve communication between clinicians and patients about the risks and benefits of opioid therapy for chronic pain, improve the safety and effectiveness of pain treatment, and reduce the risks associated with long-term opioid therapy, including opioid use disorder, overdose, and death,” the CDC said.

Although voluntary and only intended for primary care physicians, the guideline soon became the “standard of care” in the United States, with many states, doctors, insurers, pharmacies and regulators adopting its recommendations, such as limiting opioid doses to no more than 90 morphine milligram equivalents (MME) per day.

Soon after the guideline was released, the CDC was warned by its own consulting company that “some doctors are following these guidelines as strict law rather than recommendation, and these physicians have completely stopped prescribing opioids.” Over three hundred healthcare professionals also warned that forced opioid tapering was causing “an alarming increase in reports of patient suffering and suicides.”

A PNN survey two years ago found that over 85 percent of patients believed the CDC guideline made their pain and quality of life worse, significantly reduced their access to pain care, and drove some to alcohol and illegal drugs for pain relief.

Not until 2019, however, did then CDC Director Robert Redfield acknowledge the guideline was causing problems and pledged to “clarify its recommendations to help reduce unintended harms.”

Two years later, the CDC is still in the process of revising and possibly expanding the guideline, with the goal of releasing an update for public comment late this year.

Should the guideline be changed? Has it been successful in improving pain treatment? Did it reduce addiction, overdose and death?

We thought this would be a good time to conduct another survey of patients and healthcare providers, to see what changes they’d recommend to the CDC and the “Opioid Workgroup,” a panel of experts that is advising the agency.

Among the questions we’re asking is whether the recommended dose limit of 90 MME/day should be scrapped; if the guideline should be expanded to include treatment of short-term acute pain; and whether the CDC should give advice on treating specific conditions, such as low back pain or fibromyalgia.

Click here to take the survey. It should only take a few minutes to complete. Your identity and any personal health information will be kept confidential.

VALUE Study Seeks Patient Perspective on Long-Term Opioid Use

By Pat Anson, PNN Editor

In 2011, the Institute of Medicine released its landmark report, “Relieving Pain in America,” an ambitious project aimed at improving pain care, education and research in United States.

One of the report’s co-authors was Stanford University’s Dr. Sean Mackey, who remembers telling colleagues at the time that more research was needed on the long-term use of opioid pain relievers.     

“One of the questions I put forward to the group was, ‘One of the biggest questions that we need to answer is do opioids help relieve chronic pain for some people?’ Do they actually work? And if so, for whom do they work?” Mackey recalls.

“And surprisingly, ten years later, here we are in 2021 and I would submit to you that we still don’t know the answer to that question. We still do not know how well long-term prescribing of opioids work for chronic pain and for which person they work for. We understand much better who they don’t work for. But we don’t know the flip side.”

Mackey is now leading a study aimed at finally answering the question. The VALUE study is designed to give patients a voice in determining whether opioids can be a safe, effective and long-term treatment for chronic pain.

Mackey and co-investigator Beth Darnall, PhD, along with a team of patient advocates, hope to get up to 500 chronic pain sufferers to enroll in their year-long study. Patients will be asked to participate in three online surveys and three phone calls, answering questions about their pain, symptoms, mood, sleep, quality of life, and whether they encountered any problems or stigma from using opioids.

Long-Term Studies Lacking

Many doctors, regulators and opioid critics claim – disingenuously – that there is no evidence supporting the long-term use of opioids. But the truth is the same could be said for all pain relievers, including non-opioids. Few placebo-controlled studies have been conducted on the long-term use of any pain medication -- simply because it would be unethical to subject a participant to untreated pain for a lengthy period.

That leaves it to patients to share their own experiences with opioids, and a shrinking pool of doctors like Mackey who are not afraid to prescribe them.

“In my caring for people who suffer from pain and for whom it takes a big toll, I have clearly seen a subset of people for whom they do work,” Mackey told PNN. “What we’re trying to do here is transcend what has become a one-size-fits-all approach to patient treatment and the issue of opioids. We’ve become rather guideline-based and we treat all people as if they were an average in a clinical trial. I don’t treat averages. I treat people.

“Everybody is unique and deserves to be treated as an individual. That doesn’t mean that we can’t be guided by those research studies and averages, but we need to get at a more personalized approach. We need to recognize, at least in many of our experiences, there are sub-groups of people who respond to opioids. The problem is we don’t have good data on who they are.”

People who volunteer for the VALUE study should be prepared to spend a fair amount of time answering questions. Each survey will take about 45 minutes to complete. Participants will complete the first survey when they enroll, the second one after 6 months, and the third survey after one year. For each completed survey, patients will be compensated with an Amazon or gift card.

All information collected will be confidential, and won’t be shared with doctors, regulators or insurers. Participants can even use a pseudonym if they don’t feel comfortable using their real names. The VALUE study website has a list of other frequently asked questions.

People interested in participating should contact study coordinator Hannah Cunningham by email at hcunning@stanford.edu or by calling 1-833-668-0277.

“We believe our findings will have broad policy indications at local, state and national levels that will hopefully make opioid prescribing guidelines more patient centered, more effective and safer,” says Mackey.

New European Guideline Says Opioids ‘Do Not Work’ for Many Types of Chronic Pain

By Pat Anson, PNN Editor

Calling opioid medication a “two edged sword,” the European Pain Federation (EFIC) has released new guidelines that strongly recommend against using opioids to treat fibromyalgia, low back pain, migraine, irritable bowel syndrome and other types of chronic non-cancer pain.

“The new recommendations advise that opioids should not be prescribed for people with chronic primary pain as they do not work for these patients,” the EFIC said in a statement.

However, the guideline states that low doses of opioids may be suitable for treating “secondary pain syndromes” caused by surgery, trauma, disease or nerve damage, but only after exercise, meditation and other non-pharmacological therapies are tried first.

“Opioids should neither be embraced as a cure‐all nor shunned as universally dangerous and inappropriate for chronic noncancer pain. They should only be used for some selected chronic noncancer pain syndromes if established non‐pharmacological and pharmacological treatment options have failed,” the guideline states. “In this context alone, opioid therapy can be a useful tool in achieving and maintaining an optimal level of pain control in some patients.”

Opioid pain relievers are not as widely used in Europe as they are in the United States or Canada. The EFIC said it was trying to “allay concerns over an opioid crisis” developing in Europe, as it has in North America.       

“As the leading pain science organisation in Europe, it is crucial that EFIC sets the agenda on issues such as opioids, where there are growing societal concerns. These recommendations clarify what role opioids should play in chronic pain management,” EFIC President Brona Fullen said in a statement.

The guideline’s lead author, Professor Winfried Häuser, said he and his colleagues tried to strike a middle ground on the use of opioids.

“The debate on opioid-prescribing for chronic non-cancer pain has become polarized: opioids are either seen as a dangerous risk for all patients, leading to addiction and deaths, or they are promoted as most potent pain killers for any type of pain,” said Häuser, who is an internal medicine specialist in Germany.

“Opioids are still important in the management of chronic non-cancer pain – but only in some selected chronic pain syndromes and only if established non-pharmacological and non-opioids analgesics have failed or are not tolerated.”

PROP Consulted for European Guideline

The guideline was developed by a 17-member task force composed of European experts in pain management, including 9 delegates selected by EFIC’s board “who advocate and who are critical with the use of opioids.” Only one delegate from Pain Alliance Europe represented patients.

The recommendations developed by the task force were reviewed by five outside experts, including Drs. Jane Ballantyne and Mark Sullivan, who belong to Physicians for Responsible Opioid Prescribing (PROP), an anti-opioid activist group in the U.S.  Ballantyne is PROP’s President, while Sullivan is a PROP board member. Several changes suggested by the outside experts were adopted.

Coincidentally, Ballantyne, Sullivan and three other PROP board members were involved in the drafting of the opioid guideline released in 2016 by the U.S. Centers for Disease Control and Prevention. That controversial guideline is now being rewritten by the CDC after voluminous complaints from patients and doctors that the recommendations led to forced tapering, withdrawal, uncontrolled pain and suicides.

Sullivan and two other PROP board members were also involved in drafting Canada’s 2017 opioid guideline, which was modeled after the CDC’s and provoked similar complaints from Canadian pain patients.

90 MME Recommended Limit

The CDC and Canadian opioid guidelines appear to have been used as resources by the EFIC task force, which adopted many of the same recommendations, even while acknowledging the low quality of evidence used to support them.   

One recommendation is straight out of the CDC guideline, advising European doctors to “start low and go slow.” Prescribers are urged to start patients on low doses of 50 morphine milligram equivalents (MME) or less a day and to avoid increasing the dosage above 90 MME/day.

One significant difference with the North American guidelines is that the EFIC recommends that opioids not be prescribed for fibromyalgia, migraines and other chronic “primary pain” conditions for which there is no known cause – suggesting those disorders have an emotional or psychological element that will lead to opioid abuse.

“Prescription of high doses of opioids to patients with primary pain syndromes might have been a factor driving the opioid crisis in North America,” the EFIC guideline warns.

“This was further compounded by patient characteristics that included physical and psychological trauma, social disadvantage and hopelessness that served as a trigger for reports of pain intensity prompting prescriptions of more opioids.”

Secondary pain conditions for which opioids “can be considered“ include multiple sclerosis, stroke, restless leg syndrome, Parkinson’s disease, rheumatoid arthritis, phantom limb pain, non-diabetic neuropathy, spinal cord injuries and Complex Regional Pain Syndrome (CRPS). 

Unlike the North American guidelines, the EFIC acknowledges that there are physical and genetic differences between patients. Some patients who are rapid metabolizers “might require higher dosages of opioids than the ones recommended by the guidelines.“

EFIC GRAPHIC

The EFIC also warns that its guideline should not be used to justify abruptly tapering or discontinuing opioids for anyone already prescribed at higher dosages. The recommendations are also not intended for the management of short-term acute pain, sickle cell disease or end-of-life care.