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.    

Is Recreational Drug Use a Human Right?

By Roger Chriss, PNN Columnist

The book “Drug Use for Grown-Ups” by Carl Hart, PhD, is garnering a lot of attention. Hart argues that recreational drug use is a fundamental human right, while also describing the harms of drug laws and policy on people of color. His book is a mixture of anecdote and analysis that raises a lot of important issues about drugs and society.

Hart is unapologetic about his own drug use and that of others, saying that "Adults should be permitted the legal right to sell, purchase, and use recreational drugs of their choice." He sees drug use as “beneficial for human health and functioning” and causing ‘little or no harm” in most instances.

Specifically, Hart states that drug use is an "act that the government is obliged to safeguard” because it is a part of the “pursuit of happiness” in the Declaration of Independence. He claims that Thomas Jefferson, one of the authors of the Declaration, was “a long-term avid drug user.”

Hart, who is a psychology professor at Columbia University, raises numerous questions in a blunt and sometimes brusque fashion, asking “Why is it that guns can be legally purchased but heroin cannot?”

He challenges his readers with remarks like: “Few would balk at using Viagra or Cialis to enhance sexual performance, but many more find it objectionable to use drugs such as amphetamines to improve the sexual experience.”

Hart doesn't mythologize or romanticize drugs or their users, and questions why advocates of the psychedelic movement call themselves “psychonauts.”

“The term psychonaut in itself is another attempt to dissociate middle-class psychedelic users from users of drugs such as crack and heroin, who are disapprovingly called ‘crackheads’ or ‘dope fiends’.”

Hart defends this position by pointing out that nearly 80 percent of illicit drug users don’t have problems such as addiction. He explains that his own heroin use is rational: “Like vacation, sex, and the arts, heroin is one of the tools that I use to maintain my work-life balance.”

As for overdose deaths, Hart contends that contaminated drugs are the issue. “A regulated market, with uniform quality standards, would virtually put an end to contaminated drug consumption and greatly reduce fatal, accidental overdoses,” he writes.

Further, Hart states that drug addiction is not a brain disease, writing that there is no evidence indicating that “responsible recreational drug use” causes brain abnormalities. He says obsessing over addiction has caused harm by stigmatizing drug users as unworthy of social support or rehabilitative care. Hart sees the opioid crisis as overblown and rooted in racism.

“All the evidence from research clearly shows that most heroin users are people who use the drug without problems, such as addiction; they are conscientious and upstanding citizens,” he writes. “The new ‘get tough on opioids’ policies have been fueled by the mistaken perception that most illegal opioid dealers are black or Latino.”

Legalization, Hart claims, is the key to changing all this. Prohibition of alcohol gave birth to criminal gangs and a thriving underground market in booze, some of it so contaminated with impurities it made people sick or even killed them. “This problem went away when Prohibition was repealed,” he points out.

But not all of this holds up so well. Hart argues that a legalized market with regulated substances would keep people safe, but he himself chooses to use an illicit substance called “hex” of unknown provenance and effect while at a drug festival.

“I now include hex among the drugs I might want to take immediately before attending some awful required social event, such as an academic reception or an annual departmental holiday party,” he wrote.

Hart’s book is also notable for what it lacks. He doesn’t look at public health data or long-term studies on drug risks and user outcomes in the U.S. or other countries, and ignores animal research on drug risks and harms.

Hart also omits recent discouraging research on drug legalization and social justice. According to the University of Washington’s Alcohol & Drug Abuse Institute, legalization of cannabis has had no impact on reducing racial bias in policing and other disparities in the criminal justice system.   

He also doesn’t discuss the under-treatment of pain in people of color due to myths about higher pain tolerance, lack of nerve endings, or greater abuse and addiction risk.

Hart clearly shows the harms of current drug policy, but arguably overstates the potential benefits of legalization. And his blunt style sometimes diminishes his own credibility.  Overall, the book “Drug Use for Grown-Ups” adds to the discussion of drug policy in the U.S. by asking some challenging questions, but doesn’t resolve many important issues.

Roger Chriss lives with Ehlers Danlos syndrome and is a proud member of the Ehlers-Danlos Society. Roger is a technical consultant in Washington state, where he specializes in mathematics and research.

“Drug Use for Grown-Ups” is featured in PNN’s Suggested Reading section, along with other books on pain treatment and drug policy.

Abuse of Rx Opioid Painkillers Unchanged During Pandemic

By Pat Anson, PNN Editor

An alarming spike in U.S. overdose deaths during the COVID-19 pandemic does not appear to be fueled by increased abuse of opioid painkillers, according to a new nationwide analysis of urine drug tests.

The Drug Enforcement Administration approved an exemption last year allowing patients to connect with doctors via telehealth – without a physical examination -- to get prescriptions for opioids and other controlled substances. While the relaxed rules made it easier for patients to get pain medication during the pandemic, they have not resulted in more diversion or abuse of oxycodone and hydrocodone, according to the Millennium Health Signals Report. Urine positivity rates for the two opioids remained flat during 2020.

“Despite the hardships faced during the pandemic, it is encouraging to see that positivity rates for non-prescribed use of hydrocodone and oxycodone have not changed,” said Michael Parr, MD, an addiction treatment specialist and consultant to Millennium.

“Patients requiring opioids for the treatment of pain have faced difficulty obtaining medications, as well as stigma, before the pandemic. Perhaps this data will reassure clinicians who have taken additional steps to safely prescribe these medications during the pandemic.”

There was an uptick in positivity rates for non-prescribed tramadol, a weaker opioid, particularly in Ohio, Tennessee and Kentucky. Millennium said there were more cases of people with substance use disorders using tramadol as their “drug of preference.”

Millennium researchers also found that positivity rates for non-prescribed gabapentin (Neurontin) showed little change in 2020 – but they remain at levels nearly three times higher than positivity rates for oxycodone, hydrocodone and tramadol. The abuse of non-prescribed gabapentin did rise significantly in Ohio and Virginia.

POSITIVITY RATES FOR NON-PRESCRIBED PAIN MEDICATIONS

SOURCE: MILLENNIUM HEALTH

The abuse of gabapentin has been going on for years, but with little public attention. Gabapentin is a non-opioid nerve medication increasingly prescribed for pain, despite the fact many patients say it doesn’t help and has too many side effects. Drug abusers, however, have found that gabapentin can heighten the effect of heroin and other street drugs.

While positivity rates for non-prescribed pain medication were mostly unchanged during the pandemic, they soared for illicit fentanyl and methamphetamine, increasing 78% and 29%, respectively.

After initially increasing in the early stages of the COVID-19 crisis, Millennium found that positivity rates for cocaine and heroin soon returned to pre-pandemic levels.

Another encouraging sign is that positivity rates for carfentanil, a deadly fentanyl analogue, have flatlined to nearly zero. It is unclear why carfentanil abuse has fallen so sharply, but Millennium said it may be because the pandemic has disrupted manufacturing and supply routes from China.     

A Flawed Person's Drug Problem Isn't a Moral Failing

By Dr. Lynn Webster, PNN Columnist

Rush Limbaugh was as controversial as he was politically influential. In fact, Nicole Hemmer, a research scholar at Columbia University, called Limbaugh "the man who created Donald Trump" and opined that Limbaugh created the political foundation that catapulted Trump to power.

In 2020, President Trump returned the favor by awarding Limbaugh the Medal of Freedom, our highest civilian honor, for his "decades of tireless devotion to our country."

But the Independent points out that Limbaugh also left behind a legacy of "divisiveness, cruelty, racism, homophobia, bigotry, and sexism." And Rolling Stone said the radio host "trafficked in bigotry and cruelty."

RUSH LIMBAUGH

It's hard to argue with either of those statements. To me, Limbaugh was a deeply flawed human being who caused harm. But some statements about him go too far.

When Limbaugh died this week after a lengthy battle with lung cancer, Mark Frauenfelder, editor of The Magnet, tweeted: "Rush Limbaugh, the sex tourist and drug addict whose four marriages, mockery of people after their deaths, and overt racism and misogyny made him a beloved icon of American conservatism, is dead at 70." 

That statement is troubling. Overt racism and misogyny are character flaws. Drug addiction, however, is not. It's unfortunate to see Limbaugh's detractors point to his well-documented problems with painkillers as moral failings. This supports my firm belief that our culture holds deeply negative views of people with addiction.  

History of Back Pain and Drug Use 

Limbaugh began abusing prescription painkillers after his spinal surgery in the 1990s. He was eventually arrested on drug charges — specifically, charges of fraud to conceal information to obtain prescriptions, also known as "doctor shopping." In exchange for having the charges dropped, Limbaugh agreed to undergo drug treatment and pay $30,000 in court costs. He posted $3,000 bail and was released.

I wrote about Limbaugh's prescription drug problem in my book, "Avoiding Opioid Abuse While Managing Pain." What we knew about Limbaugh's problem, as I said at the time, was that he abused large quantities of prescription opioids for several years; kept his abuse secret from family, friends and colleagues; entered a rehabilitation program twice, but relapsed each time; remained successful without a visible reduction in functioning while he used drugs; and was suspected of buying drugs illegally. 

What we didn't know, and perhaps now can never ascertain, is whether Limbaugh had an addiction or an undiagnosed psychiatric disorder (although some may argue his professional conduct was evidence of a disturbed personality). We also can't know whether his main motivation for using drugs was to control physical pain, to mask emotional pain or stress, to seek a "high," or some combination of those reasons.  

The answers to these questions — about his history of drug abuse, mental health and motivation — would have told us whether his opioid use disorder (OUD) was treatable with better pain control or, tragically, was an incurable disease.  

Limbaugh exemplifies the type of patient most physicians face when treating serious pain conditions. Sometimes, opioids fail to provide adequate relief for them. And, increasingly, patients cannot access the opioids they need due to misguided polices and regulations.   

How Society Views Addiction 

Some people may agree with Limbaugh's political and social views, and others may not. But conflating his drug abuse and associated illegal activities with the opinions he expressed about social issues harms people who suffer from the disease of addiction. It also makes it more difficult for people with severe pain to receive the care they deserve, whether their abuse is caused by addiction or, as is often the case, a symptom of undertreated pain. 

Many of those with addiction may not have the power or influence to bail themselves out of prison or pay tens of thousands of dollars in court costs. They may remain in prison for years and suffer the loss of their careers, reputations, homes and even their families.  

Generally, our society views people with addiction as flawed, weak and hopeless. We distance ourselves from those who have the disease, and we allow the criminal justice system to have jurisdiction over them, making it difficult or even impossible for them to receive treatment.  

We may never know why Rush Limbaugh made the choices he did. But, just as we would never think of berating him for falling victim to lung cancer, we also shouldn't chastise him for misusing painkillers. We may have a right to judge Limbaugh's behavior, but we cannot, in decency, judge his disease. 

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

Gabapentinoids Riskier for Surgery Patients

By Pat Anson, PNN Editor

Another study is casting doubt on the use of gabapentinoids such as Lyrica (pregabalin) and Neurontin (gabapentin) for pain relief during and after surgery.

Gabapentioids are a class of nerve medication originally developed to treat convulsions, but the drugs are increasingly being used as a trendy alternative to opioids for acute and chronic pain. Some U.S. hospitals are even using gabapentinoids for surgical pain and have phased out or reduced the use of opioids.

In an analysis of over 5 million adults admitted for major surgery in the U.S. from 2007 to 2017, researchers at Harvard Medical School found that using gabapentinoids with opioids increases the risk of overdose, respiratory depression and other adverse events. Researchers say the additional risk was “extremely low” and would result in one additional overdose for every 16,000 patients.

“Our findings add to the growing evidence that gabapentinoids can potentiate the respiratory depressant effects of opioids,” researchers reported in JAMA Network Open. “The events were rare… (but) patients receiving multimodal pain management therapy that includes gabapentinoids should be closely monitored for possible respiratory depression.”

The study did not examine whether gabapentiniods were effective in treating surgical pain or if they improved the analgesic effect of opioids.

In an editorial also published in JAMA Network Open, a pain management expert said more studies were needed to see if gabapentiniods were worth the additional risk.

“The evidence in support of the analgesic benefit of gabapentinoids combined with opioids for postoperative analgesia is equivocal; there is no real support that adding gabapentinoids to opioid pain relievers offers additive, much less synergistic, enhancements to pain control,” wrote Joseph Pergolizzi, Jr, MD, Chief Operating Officer of NEMA Research.  

“Considering that combination analgesic regimens generally reduce overall opioid consumption, this study is important because it shows that this may not necessarily translate to reducing opioid-associated adverse events. As combination analgesia gains traction for in-hospital acute painful conditions, such as postsurgical pain, it is important to be guided by evidence rather than intuition.”

No Significant Analgesic Effect

A recent study by Canadian researchers also found little evidence to support the use of gabapentinoids for surgical pain.

“No clinically significant analgesic effect for the perioperative use of gabapentinoids was observed. There was also no effect on the prevention of postoperative chronic pain and a greater risk of adverse events,” wrote lead author Michael Verret, MD, a resident at Laval University in Quebec City.  

These and other findings contradict guidelines published by the American Pain Society in 2016, which advocate “around the clock” use of gabapentin, pregabalin and other non-opioid drugs both before and after surgery.

The risk of becoming addicted or dependent on opioids after surgery is actually quite low. A 2016 study found that only 0.4% of elderly patients who were prescribed opioids for post-operative pain were still using them a year after their surgeries. Another study by Harvard researchers found that only 0.2% of surgery patients prescribed opioids were later diagnosed with opioid dependence, abuse or a non-fatal overdose.

Growing Concerns About Opioid Tapering

By Roger Chriss, PNN Columnist

A common belief about the opioid crisis assumes that patients develop a substance use disorder from taking opioid medication, and that many derive no long-term benefit from opioids and need to be tapered.

There is some truth to this, but reality is much more complicated.

First, not all patients who take opioids become addicted. The National Institute on Drug Abuse reports between 8 and 12 percent of patients prescribed opioids for chronic pain develop an opioid use disorder (OUD). Even that estimate may be too high, because the diagnosis of OUD is sometimes mistaken.  

In a recent study of 90 patients diagnosed with OUD at three Veterans Health Administration medical centers, physician Ben Howell and colleagues found that nearly a third of the diagnoses were probably wrong.

“Our study identified significant levels of likely inaccurate OUD diagnoses among veterans with incident OUD diagnoses. The majority of these cases reflected readily addressable systems errors,” researchers concluded. “If these inaccuracies are prevalent throughout the VHA, they could complicate health services research and health systems responses.”

Second, not all people who are tapered off prescription opioids improve. A new study in the Journal of Pain Research looked at 40 chronic pain patients who were tapered from an average daily dose of 80 MME (morphine milligram equivalent) down to 19 MME. The results were disappointing. There was only minor improvement in the patients’ cognitive function and no improvement in their quality of life, depression and anxiety.

There is at present no well-established approach to opioid tapering and little effort made to study patient outcomes.  In a recent paper, lead author Stefan Kertesz, MD, and colleagues say there is a “pill dynamic” approach to tapering that focuses on dose reduction alone.

"When a multi-faceted, complex health issue becomes a public health crisis, the desire to ‘solve’ or ‘mitigate’ takes hold with a momentum of its own. A crisis deserves no less. However, nationally adopted quality metrics have convinced some patients with pain that their survival and functioning are no longer concerns for the systems in which they receive care. This outcome is unacceptable," they concluded.

Patient Suffering and Suicides

The risks of forced opioid tapering are so urgent that nearly 100 physicians, academics and patient advocates recently published an open letter in the journal Pain Medicine warning of “an alarming increase in reports of patient suffering and suicides” caused by aggressive tapering:

“We therefore call for an urgent review of mandated opioid tapering policies for outpatients at every level of health care — including prescribing, pharmacy, and insurance policies — and across borders, to minimize the iatrogenic harm that ensues from aggressive opioid tapering policies and practices.

We call for the development and implementation of policies that are humane, compassionate, patient-centered, and evidence-based in order to minimize iatrogenic harms and protect patients taking long-term prescription opioids.”

The public health issue of opioid overdoses is complex, urgent and largely driven by street drugs, not pain medication. Opioid prescriptions are at 20-year lows, and the American Medical Association recently said it was “alarmed by an increasing number of reports of opioid-related overdoses, particularly from illicit fentanyl.”

And as National Institute of Drug Abuse director Nora Volkow, MD, stated in a recent blog post:

“Although deaths from opioids continue to command the public’s attention, an alarming increase in deaths involving the stimulant drugs methamphetamine and cocaine are a stark illustration that we no longer face just an opioid crisis. We face a complex and ever-evolving addiction and overdose crisis characterized by shifting use and availability of different substances and use of multiple drugs (and drug classes) together.”

Opioid tapering is no more a universal good than opioid prescribing was a universal evil. And opioid tapering will no more solve the overdose crisis than opioid prescribing alone caused it. Instead, opioid tapering may harm the very people it is intended to help, and it may not help the crisis that it is motivated by. Better public health policy and clinical practice are urgently needed.

Roger Chriss lives with Ehlers Danlos syndrome and is a proud member of the Ehlers-Danlos Society. Roger is a technical consultant in Washington state, where he specializes in mathematics and research. 

Do Prescription Opioids Increase Social Pain and Isolation?

By Pat Anson, PNN Editor

Long-term use of opioid medication may increase social isolation, anxiety and depression for chronic pain patients, according to psychiatric and pain management experts at the University of Washington School Medicine.

In an op/ed recently published in Annals of Family Medicine, Drs. Mark Sullivan and Jane Ballantyne say opioid medication numbs the physical and emotional pain of patients, but interferes with the human need for social connections.

“Their social and emotional functioning is messed up under a wet blanket of opioids,” Sullivan said in a UW Medicine press release.

Sullivan and Ballantyne are board members of Physicians for Responsible Opioid Prescribing (PROP), an influential anti-opioid activist group. Ballantyne, who is president of PROP, was a member of the “Core Expert Group” that advised the CDC during the drafting of its controversial 2016 opioid guideline. She has retired as a professor of pain medicine at the university, while Sullivan remains active as a professor of psychiatry.

In their op/ed, Sullivan and Ballantyne say it is wrong to assume that chronic pain arises solely from tissue damage caused by trauma or disease. They cite neuroimaging studies that found emotional and physical pain are processed in the same parts of the human brain.  While prescription opioids may lessen physical pain, they interfere with the production of endorphins – opioid-like hormones that help us feel better emotionally.

“Many of the patients who use opioid medications long term for the treatment of chronic pain have both physical and social pain,” they wrote. “Rather than helping the pain for which the opioid was originally sought, persistent opioid use may be chasing the pain in a circular manner, diminishing natural rewards from normal sources of pleasure, and increasing social isolation.

“To make matters worse, the people who need and want opioids the most, and who choose to use them over the long term, tend to be those with the most complex forms of chronic pain, containing both physical and social elements. We have called this process ‘adverse selection’ because these are also the people who are also at the greatest risk for continuous or escalating opioid use, and the development of complex dependence.”

Sullivan and Ballantyne say doctors need to recognize that when patients have both physical and social pain, long-term opioid therapy is “more likely to harm than help.”

“We believe that short-term opioid therapy, lasting no more than a month or so, will and should remain a common tool in clinical practice. But long-term opioid therapy that lasts months and perhaps years should be a rare occurrence because it does not treat chronic pain well, it impairs human social and emotional function, and can lead to opioid dependence or addiction,” they wrote.

Angry and Depressed Patients

It’s not the first time Sullivan and Ballantyne have weighed in on the moods and temperament of chronic pain patients. In a 2018 interview with Pain Research Forum, for example, Ballantyne said patients often have “psychiatric comorbidities” and become “very angry” at anyone who suggests they shouldn’t be on opioids.

“I’ve never seen an angry patient who is not taking opiates. It’s people on opiates who are angry because they’re frightened, desperate, and need to stay on them. And I don’t blame them because it is very difficult to come off of opiates,” she said.

In a 2017 interview with The Atlantic, Sullivan said depression and anxiety heighten physical pain and fuel the need for opioids. “People have distress — their life is not working, they’re not sleeping, they’re not functioning,” Sullivan said, “and they want something to make all that better.”

JANE BALLANTYNE MARK SULLIVAN

In a controversial 2015 commentary they co-authored in the New England Journal of Medicine, Sullivan and Ballantyne said chronic pain patients should learn to accept pain and get on with their lives, and that relieving pain intensity should not be the primary focus of doctors. The article infuriated both patients and physicians, including dozens who left bitter comments.

“Great job. I will be going into the coffin business thanks to these believers that people should suck it up. How NEJM even recognizes these people as doctors and not quacks is beyond me,” wrote a family practice physician.

“I take just enough narcotic pain meds to cut the edge off of my pain to be coherent enough to love my wife and respond to your constant misinformation,” wrote a patient.

Ballantyne and Sullivan’s op/ed in Annals of Family Medicine has yet to produce a similar response, either pro or con. The article was submitted to the journal over a year ago, but is only being published now.

Ballantyne disclosed in her conflict-of-interest statement that she has been a paid consultant in opioid litigation lawsuits, while Sullivan disclosed that he provided expert testimony for the states of Maryland and Missouri.

Other PROP board members have also found a lucrative sideline testifying in lawsuits. The organization is currently conducting a fundraiser to hire a new Executive Director to “take PROP's work to the next level.”

Can Cannabis Be Used to Treat Opioid Addiction?

By Pat Anson, PNN Editor

Canadian researchers – with funding from U.S. taxpayers – are proposing a novel treatment for opioid use disorder: Cannabis.

In a paper published in the journal Drug and Alcohol Dependence, researchers from the University of British Columbia (UBC) and the BC Centre on Substance Use (BCCSU) say cannabis could help people being treated for opioid addiction by reducing their risk of exposure to illicit fentanyl and other street drugs.

The finding is based on urine drug tests of 819 people being treated for opioid addiction in Vancouver, BC, the first major city in North America to experience an outbreak of fentanyl-related overdoses. Addiction treatment usually involves taking opioid agonist drugs (OATs) such as buprenorphine or methadone.

The researchers found that over half the participants (53%) tested positive for fentanyl, suggesting they were still using street drugs. Those who tested positive for THC -- the psychoactive compound in cannabis -- were about 10 percent less likely to have fentanyl in their urine.

"These new findings suggest that cannabis could have a stabilizing impact for many patients on treatment, while also reducing the risk of overdose," said lead author Eugenia Socías, MD, a clinician scientist at BCCSU. "With overdoses continuing to rise across the country, these findings highlight the urgent need for clinical research to evaluate the therapeutic potential of cannabinoids as adjunctive treatment to OAT to address the escalating opioid overdose epidemic."

Socias and her colleagues say cannabis may play an important role in keeping people in addiction treatment programs. Previous research at BCCSU found that drug users initiating OAT who used cannabis daily were about 21 percent more likely to be retained in treatment after six months than non-cannabis users. People who stay in treatment face much lower risks of dying from an overdose, acquiring HIV or suffering other harms of drug use.

‘Gateway Drug’

The research at UBC and BCCSU was funded, in part, by grants from the U.S. National Institute on Drug Abuse, which is part of the National Institutes of Health (NIH).

The NIH has taken a dim view of cannabis in the past, calling marijuana a “gateway drug” for some users, particularly adolescents. A 2015 study funded by NIH found that nearly a third of those who use marijuana develop some degree of marijuana use disorder.

“Whether smoking or otherwise consuming marijuana has therapeutic benefits that outweigh its health risks is still an open question that science has not resolved,” said Nora Volkow, MD, Director of the National Institute on Drug Abuse.

Public health officials in British Columbia have proposed some controversial solutions to the opioid crisis, including decriminalization of all illicit drugs. A treatment center in Vancouver currently provides diacetylmorphine -- prescription heroin – to drug users to keep them from using street heroin that is often laced with fentanyl, a synthethic opioid that is 50 to 100 times more potent than morphine.

The Canadian Institutes of Health Research recently approved funding for a pilot study in Vancouver to evaluate cannabis as an adjunct therapy to OAT.

"Scientists are only just beginning to understand the role cannabis might play in supporting people's well-being, particularly those who use other substances," said co-author M-J Milloy, PhD, the Canopy Growth professor of cannabis science at UBC. "This study will help us understand if and how cannabis might have a role in addressing the overdose crisis."

A Little Shop of Horrors: VA Opioid Guideline for Veterans

By Richard Lawhern, PNN Contributor

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Prescription Opioid Use at 20-Year Lows

By Pat Anson, PNN Editor

Prescription opioid use in the United States is expected to decline for the ninth consecutive year in 2020, with per capita consumption of opioid medication falling to its lowest level in two decades, according to a new report by the IQVIA Institute, a data analytics firm.

Although fewer opioids are being prescribed, U.S. drug overdose deaths have reached record levels, driven largely by illicit fentanyl and other streets drugs, not pain medication.

In the past year alone, IQVIA estimates there was a 17 percent decline in the amount of prescription opioids dispensed in morphine milligram equivalent (MME) units. The decrease is being driven by changes in prescribing policy, government regulation and insurance reimbursement policies, as well as disruptions in healthcare caused by the COVID-19 pandemic.

In the early stages of the pandemic, IQVIA researchers say there was a 44% decline in the number of new patients prescribed opioids, likely the result of providers and patients canceling non-emergency visits, dental appointments and elective surgeries. As the economy reopened in early summer and healthcare visits resumed, opioid prescribing for pain returned to baseline levels, as did prescriptions for addiction treatment drugs.

“The opioid epidemic has captivated the country for a decade, although it lost attention this year in the face of the COVID-19 pandemic. Patients with chronic pain and addiction have also been affected by disruptions to life and healthcare during COVID, when hospitals, doctors’ offices, and drug treatment facilities were closed,” Murray Aitken, Executive Director IQVIA Institute for Human Data Science, said in a statement.

“While the human toll of the opioid epidemic is being addressed differently across the country, efforts in managing prescription opioids and in supporting medication-assisted treatment are showing measurable progress in many states.”

Prescription opioid use peaked in 2011 and has been in steep decline ever since. By the end of 2020, IQVIA projects per capita annual opioid consumption to fall to 298 MME, nearing a level last seen in 2000.

SOURCE: iqvia iNSTITUTE

“Based on usage in the mid-1990s, it may be difficult to reduce current prescription opioid levels further, as pain medications are necessary for some patients, including cancer patients, until other non-addictive or disease-modifying treatments are available,” the IQVIA report found.

Over the past decade, the greatest decline in prescription opioid use has been in the highest risk categories. Prescriptions written for 90 MME or more per day – a level considered risky by the CDC – have fallen by 70 percent since 2011.

Co-prescribing of opioids with benzodiazepines – an anti-anxiety medication – is also falling rapidly. The number of patients taking both drugs has declined from 86 million in 2016 to less than 60 million in 2020. Opioids and benzodiazepines both slow respiration, and patients who take them in combination are believed to be at higher risk of an overdose.

Overdoses Still Rising

Despite the historic decline in prescription opioid use, U.S. overdose deaths hit a record high last spring, according to a new report from the CDC.  For the 12 months ending in May 2020, over 81,000 people died of a drug overdose.

"This represents a worsening of the drug overdose epidemic in the United States and is the largest number of drug overdoses for a 12-month period ever recorded," the CDC said in a health advisory, adding that the deaths were largely driven by illicit fentanyl, heroin, cocaine and psychostimulants such as methamphetamine. Opioid pain medication is not even mentioned in the CDC report.

“The disruption to daily life due to the Covid-19 pandemic has hit those with substance use disorder hard,” CDC director Robert Redfield said in a statement. “As we continue the fight to end this pandemic, it’s important to not lose sight of different groups being affected in other ways. We need to take care of people suffering from unintended consequences.”

Some federal agencies haven’t gotten the message and continue to blame opioid medication and prescribers for the nation’s overdose epidemic.

A new report released this week by the Office of Inspector General (OIG) for Health and Human Services warns that thousands of Medicaid patients in six Appalachian states are being prescribed “harmful amounts” of opioids. The report also identifies 19 physicians with “questionable prescribing practices” and said they will be referred to law enforcement.  

“OIG, along with its law enforcement partners, will review the prescribers with questionable prescribing patterns for possible investigation. OIG will also refer the beneficiaries at serious risk for opioid misuse or overdose to their respective State Medicaid agencies for review and possible followup to ensure that they are receiving appropriate care,” the report states.

“Further, we encourage States to provide greater access to data from prescription drug monitoring programs, including sharing these data with State Medicaid agencies. We also encourage States to analyze data to help identify patients who may be at risk and to promote appropriate opioid prescribing practices.”

AMA ‘Greatly Concerned’ By Rising Number of Opioid Overdoses

By Pat Anson, PNN Editor

The American Medical Association is once again urging states, regulators and policymakers to waive limits and restrictions on prescriptions for opioid medication and other controlled substances during the COVID-19 pandemic.

In a briefing paper released this week, the AMA said it was alarmed by an increasing number of reports of opioid-related overdoses, particularly from illicit fentanyl. The AMA cited recent reports from the Pacific Northwest that thousands of people were unexpectedly dying from causes other than COVID-19, such as fentanyl-laced counterfeit pills and medical conditions aggravated by delays in getting routine healthcare.    

“The AMA is greatly concerned by an increasing number of reports from national, state and local media suggesting increases in opioid-and other drug-related mortality—particularly from illicitly manufactured fentanyl and fentanyl analogs,” the AMA said. “More than 40 states have reported increases in opioid-related mortality as well as ongoing concerns for those with a mental illness or substance use disorder.”

The AMA urged states to adopt new DEA guidance giving more flexibility to physicians treating patients with opioid use disorder (OUD). The DEA has already waived federal requirements for in-person visits before prescribing addiction treatment drugs such as buprenorphine (Suboxone), methadone and naltrexone.

For patients in pain, the AMA recommended that states take a number of steps to make it easier to obtain pain medication during the pandemic:

• Authorize physicians to prescribe opioid medication to existing patients without an in-person visit

• Waive limits on prescriptions for opioids and other controlled substances, including limits on dose, quantity and refills

• Waive requirements on electronic prescribing; authorize prescriptions to be sent to pharmacies via telephone

• Waive drug testing and in-person counseling requirements for opioid refills; allow for telephone counseling

• Enhance home-delivery medication options for patients with chronic pain

The AMA urged many of these same measures be adopted in the early stages of the pandemic.

In a recent letter to the DEA, the AMA strongly recommended that the agency keep its relaxed prescribing guidelines in place indefinitely.

“There is an urgent need to ensure that patients with pain and patients with OUD receive evidence-based care, and this need will not cease with the end of the COVID-19 pandemic,” wrote James Madara, MD, Executive Vice President and CEO of the AMA..

“The AMA strongly recommends, therefore, that all of the flexibilities that have been put in place by DEA during the COVID-19 PHE (public health emergency) be kept in place at a minimum until both the COVID-19 and the opioid public health emergencies come to an end.”

Understanding the Difference Between Prescription Fentanyl and Illicit Fentanyl

By Roger Chriss, PNN Columnist

The opioid overdose crisis is now being driven by fentanyl. But misunderstandings over what fentanyl is, where it comes from, how it is used and why have become so pervasive that they plague discourse and debate about the crisis. News reports about “fentanyl overdose deaths” appear almost daily.

October saw a particularly tragic death. As reported by the Daily Courier in Prescott, Arizona, a 14-year-old high school student died of an overdose after taking what investigators suspect was a counterfeit pill “laced with the potent narcotic painkiller fentanyl.”

The tragedy of this death cannot be overstated. Nor can thousands of other overdose fatalities caused by fentanyl. But the nature of the drug needs to be better understood if we are to prevent such deaths moving forward.

Fentanyl is not one drug. It is better thought of as a family of synthetic opioids that are structurally similar, and includes sufentanil and remifentanil. These are pharmaceutical fentanyls, used clinically as anesthetics and essential for medical procedures such as open heart surgery.

Collectively, these drugs are part of a super-family known as fentanyl analogues. There are dozens of such drugs. Some are compounds developed by pharmaceutical companies for legitimate medical use, and others are manufactured illegally for use as street drugs. These forms of fentanyl are commonly referred to as “illicitly manufactured fentanyl” by government agencies like the CDC. The DEA has classified “fentanyl-related substances” as Schedule I controlled substances, meaning they are illegal to manufacture, distribute or possess.

To make this even more complicated, the fentanyl drug carfentanil is used legally in the U.S. as a tranquilizer for elephants and other large animals. The DEA authorizes production of a minute quantity of carfentanil for veterinarians every year. But illicit carfentanil from overseas occasionally shows up on the street and causes fatal overdoses.

Further muddying matters is the new fentanyl-like street drug isotonitazene, which is known colloquially as “iso.” It is “fentanyl-like” in its risks and harms, but is not technically a fentanyl analogue. “Iso” is instead related to etonitazene. Neither of these drugs has any recognized medical use in humans.

Risks Are Very Different

In other words, there is a vast gulf between pharmaceutical fentanyl and illicitly manufactured fentanyl. The former is a tightly controlled Schedule II prescription medication, approved for use in hospitals and to treat breakthrough cancer pain. The latter is an illegal substance cooked up in illicit labs that is often added to heroin or used to make counterfeit pills, which are then sold on the street or online.

This distinction is critical for understanding the opioid overdose crisis. The risks of a prescription opioid like fentanyl when given for medical use to a legitimate patient are very different from the risks of an illicit opioid being used non-medically by a random street buyer. Importantly, the risks for medical use can be addressed and managed. The risks of illicit use are much harder to deal with and often prove fatal.

The distinction also leads to confusion. The abundance of fentanyl on the street is rarely a result of diversion, and is unrelated to the supply of pharmaceutical fentanyl. These are different drugs, much as the cocaine nasal spray recently approved by the FDA as a local anesthetic is completely separate from the cocaine bought on the street. Pain experts are now pushing for a new classification for illicit fentanyl analogues, in the hope of clarifying this difference.

But fentanyl has so saturated the street drug market that more than a name change will be needed. As Ben Westhoff explains in the book “Fentanyl, Inc.”, preventing future opioid deaths will require “sweeping new public-health initiatives, including treatment programs and campaigns to educate everyone, from users and medical providers to teachers and police, about the drugs’ dangers.”

Understanding the difference between pharmaceutical fentanyl and illicitly manufactured fentanyl is an essential step in the effort to reduce overdose deaths.

Roger Chriss lives with Ehlers Danlos syndrome and is a proud member of the Ehlers-Danlos Society. Roger is a technical consultant in Washington state, where he specializes in mathematics and research.