Overdoses Tripled in New Jersey Despite Limits on Rx Opioids

By Pat Anson, PNN Editor

In 2017, New Jersey became one of the first states in the country to impose a hard limit on initial opioid prescriptions, with patients allowed only a 5-day supply of opioid pain medication. If they needed more, their doctor would have to write a new prescription, enroll patients in a pain management program, and counsel them about the risks of opioid addiction and overdose.

"We are here today to save lives," then-Governor Chris Christie said after signing the legislation into law. "New Jersey now leads the way first and foremost in recognizing this is a disease."

Four years later, there is little evidence the 5-day limit has reduced opioid addiction or saved lives in New Jersey. In fact, it may have made the overdose crisis worse by forcing some patients to turn to increasingly dangerous street drugs.

A new study at Rutgers University, recently published in The Journal of Substance Abuse Treatment, found that medically treated opioid overdoses among Medicaid patients more than tripled in New Jersey from 2014 to 2019.

Researchers found the overdose rate continued to rise even after the 5-day opioid limit was imposed, with opioid prescription rates nearly cut in half for Medicaid beneficiaries, falling from 23 percent in 2015 to 13 percent in 2019.   

The rising number of overdoses was primarily due to heroin and illicit fentanyl, and often involved alcohol and other drugs. Medicaid patients suffering from alcoholism, benzodiazepine addiction, depression, hepatitis C, heart failure and pneumonia had overdose rates at least 1.5 times higher than other beneficiaries.

“While high rates of opioid prescribing likely contributed to earlier increases in OUD (opioid use disorder), actions to further limit such prescribing alone may do little to reduce opioid overdose in the current environment,” wrote lead author Stephen Crystal, PhD, director of the Rutgers Center for Health Services Research.

“Policies also need to be attentive to the possibility that, if not well managed, reductions in access to prescribed opioids could lead some individuals with pain conditions and other complications, including OUD, to turn to heroin and other illicit drugs, in an increasingly dangerous environment.”

Since their peak in 2015, when over 5,640,000 opioid prescriptions were filled in New Jersey, opioid prescribing has fallen over 35% in the state. That coincided with an alarming increase in overdose deaths as illcit fentanyl began to flood New Jersey.

OPIOID PRESCRIPTIONS DISPENSED IN NEW JERSEY

Source: NJ Cares

NEW JERSEY FATAL DRUG OVERDOSES

Source: NJ Cares

Comorbid Conditions

Rutgers researchers say more attention needs to be paid to people who survive overdoses, who often live with multiple health problems and comorbid conditions. In 2019, over half suffered from major depression (51%), while others had alcohol use disorder (39%), hepatitis C (30%), bipolar disorder (28%), cannabis use disorder (26.5%) sedative/hypnotic use disorder (21%) or schizophrenia (11.5%).  

Notably, less than a third (30.4%) of New Jersey’s overdose survivors were diagnosed with a chronic pain condition, suggesting the state’s focus on limiting pain medication was misdirected at a time when more resources were needed throughout the state’s healthcare system, particularly for mental health.  

“The high level of behavioral health and medical comorbidity that we identified among individuals with overdoses has important implications for interventions in a system in which substance use treatment, mental health care, and primary medical care are often siloed,” Crystal and his colleagues wrote.

“Interventions for conditions such as alcohol use disorder, sedative-hypnotic use disorder, and chronic obstructive pulmonary disease could reduce overdose risk. High rates of mental health comorbidity among this population, including major depression, bipolar disorder and schizophrenia, also highlight the need for concomitant mental health treatment.”

New Jersey is not alone in its failed attempt to end the overdose crisis. As PNN has reported, nearly two dozen states have implemented laws limiting the initial supply of opioid medication; 17 states limit prescriptions to 7 days supply, two states cap them at 5 days, and four states limit prescriptions to just 3 days.  

These and other efforts to reduce opioid use, such as prescription drug monitoring programs (PDMPs), have resulted in prescription opioid use falling to 20-year lows in the United States, even while overdose deaths surged to record highs. Over 93,000 Americans died of drug overdoses in 2020, with the vast majority linked to illicit fentanyl and other street drugs.

The trend continues in New Jersey. In the first six months of 2021, the state reported 1,626 fatal overdoses, nearly three dozen more deaths than were recorded during the same period last year. New Jersey is on track to have a record 3,250 fatal overdoses by the end of the year.

Study Finds Childhood Trauma Increases Risk of Opioid Addiction

By Pat Anson, PNN Editor

Several studies have found that if you experienced physical or emotional trauma as a child you are more likely to have migraines, fibromyalgia and other painful conditions as an adult.

Australian researchers have taken that theory a step further, with a small study that found adults with a history of childhood abuse or neglect are more likely to feel the pleasurable effects of opioids, putting them at greater risk of addiction.

That finding, recently published in the journal Addiction Biology, is based on a double-blind, placebo-controlled study that compared the effects of morphine on 52 healthy people – 27 with a history of severe childhood trauma and a control group of 25 who had no such experiences as children.

Participants in both groups were given an injection of morphine or a placebo dose, and then asked how it made them feel. People in the trauma group reported more euphoria or feeling high and more “liking” of morphine. They also felt less nauseous and dizzy after taking the drug compared to the non-trauma control group.

“Those with childhood trauma preferred the opioid drug morphine and they felt more euphoric and had a stronger desire for another dose,” lead author Molly Carlyle, PhD, a research fellow at The University of Queensland, said in a statement. “Those with no childhood trauma were more likely to dislike the effects and feel dizzy or nauseous.

“This is the first study to link childhood trauma with the effects of opioids in people without histories of addiction, suggesting that childhood trauma may lead to a greater sensitivity to the positive and pleasurable effects of opioids.”

Researchers say people in the trauma group were significantly more likely to have a history of anxiety or depression, and to use over-the-counter pain relievers regularly.  They were also more likely to report stress, loneliness and less social support and self-compassion than the control group.

“One possible explanation for the differing responses to morphine is that childhood trauma affects the development of the endogenous opioid system – a pain-relieving system that is sensitive to chemicals including endorphins, our natural opioids,” Carlyle explained. "It's possible that childhood trauma dampens that system.

“When a baby cries and is comforted, endorphins are released, so if loving interactions like this don't happen, this system may develop differently and could become more sensitive to the rewarding effects of opioid drugs."

Pain was also measured during the study, with participants immersing a hand in cold water both before and after receiving morphine. Researchers measured how long it took for them to find the cold water painful and how long it took before they pulled their hand out. Morphine was found to increase pain threshold and tolerance in both groups, regardless of whether they experienced childhood trauma.

“The findings of this study are a stepping stone in highlighting the role of childhood trauma in OUD (opioid use disorder), emphasising the need to address trauma symptoms in this vulnerable group, and targeting early interventions at traumatised young people,” researchers concluded. “These findings have many clinical and social implications including reducing the guilt and shame common amongst those with OUD about the reasons behind the development of this damaging addiction.”

The Tangled Mess of Prescription Opioid Guidelines

By Roger Chriss, PNN Columnist

The opioid overdose crisis has impacted medical practice in unanticipated and unfortunate ways. A recent JAMA study warned that efforts to reduce opioid prescribing through tapering raises the risk of overdose and mental health crises in pain patients on stable, long-term opioid therapy.

This study is the latest to find that opioid tapering is fraught with risks. Amid this, the American Medical Association has issued a call to revamp the CDC’s problematic 2016 opioid prescribing guideline because of its “devastating” impact on pain patients.

“The CDC should remove arbitrary thresholds, restore balance and support comprehensive, compassionate care as it revises the guideline,” wrote AMA news editor Kevin O’Reilly.

But revising the CDC guideline may not have much effect. The guideline is voluntary and doesn’t have the force of law, but many states have implemented their own guidelines in ways that make them enforceable. They are often paired with requirements and regulations covering everything from daily dose and prescription duration to drug testing, pain management agreements, and tapering. These state guidelines do not necessarily follow the CDC guideline on even basic issues of dose, duration or recommended use.

Some states, including Minnesota and Oregon, have adopted the CDC’s recommended threshold of 90 morphine milligram equivalents (MME) as a maximum daily dose not requiring consultation with a pain management specialist or a special exemption. Other states make their own rules. Washington has kept to 120 MME in its latest guideline update, as has Tennessee.

State policies also differ on the merits of using opioids for chronic pain. The Medical Board of California recommends that physicians and patients “develop treatment goals together” for long-term use of opioids, while Arizona’s opioid guideline flatly warns physicians: “Do not initiate long-term opioid therapy for most patients with chronic pain.”

On tapering, states do not agree much at all and generally do not follow federal HHS guidelines that tapering be individualized and “slow enough to minimize opioid withdrawal symptoms.”

Minnesota’s opioid guideline recommends that physicians “routinely discuss tapering with patients at every face to face visit” and allows for forced, rapid tapers or discontinuation under some circumstances.

Tennessee’s guideline notes that there are “many reasons to discontinue chronic opiate therapy” and “several different weaning protocols outlined by various sources.” It does not recommend any specific one, leaving it up to individual doctors to decide how to taper their patients.

The VA and Department of Defense have their own guideline, which contains a complex set of treatment algorithms that span several pages and effectively exclude almost all patients from long-term opioid use. Further, according to a separate algorithm, the VA is clearly aiming to taper or discontinue opioids in as many patients as possible. The guideline states "If prescribing opioid therapy for patients with chronic pain, we recommend a short duration.”

The Trouble With Algorithms

Many of the state guidelines are paired with a prescription drug monitoring programs (PDMPs) and use NarxCare, a private analytics system that gives individual risk scores to every patient based on their medical and prescription drug history. PNN first covered NarxCare in 2018, noting that patients can be automatically “red flagged” by the system for seeing too many doctors or using multiple pharmacies.

Maia Szalavitz recently wrote about Narxcare in Wired, noting that legitimate patients were being denied medications or abandoned by doctors because of their Narxcare scores.

“A growing number of researchers believe that NarxCare and other screening tools like it are profoundly flawed,” Szalavitz wrote. “None of the algorithms that are widely used to guide physicians’ clinical decisions — including NarxCare — have been validated as safe and effective by peer-reviewed research.”

A similar problem exists for data from PDMPs. A well-documented analysis by Terri Lewis, PhD, found that “machine learning” algorithms are often based on untested assumptions and financial incentives for providers, not on patient care.

“The worst part of machine learning (ML) snake-oil isn’t that it’s useless or harmful — it’s that ML-based statistical conclusions have the veneer of mathematics, the empirical facewash that makes otherwise suspect conclusions seem neutral, factual and scientific,” wrote Lewis. “What the PDMP is NOT designed to do, is detect patients who are using their opioids correctly from patients who are misusing their medications.”

All of the above imposes a significant risk and burden on patients, in particular if they relocate for work or school, or seek medical care outside of their state of residence.

In essence, patients are subjected to a set of federal recommendations from the CDC that may inform some state laws or regulations that are then implemented in a privatized process with little transparency or accountability. Patients simply cannot tell what is happening at the time of implementation, and if they see a problem after the fact, it is usually too late to fix it.

The AMA’s current effort to improve the CDC guideline for opioids is a laudable step forward. But the mess is far larger and more complex, and the role of the CDC is smaller than is generally appreciated amid an abundance of contradictory guidelines and regulations.

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. 

State Laws Reduced Number of Days Opioids Prescribed

By Pat Anson, PNN Editor

State laws that limit initial opioid prescriptions to seven days or less have reduced the number of days that opioid medication is prescribed to Medicare patients for short-term acute pain, according to a new study.

Nearly two dozen states implemented laws limiting the initial supply of opioids after the CDC released its 2016 opioid prescribing guideline. Seventeen states limited prescriptions to 7 days, two states capped them at 5 days, and four states limited prescriptions to just 3 days.  

“The state legislation on opioid prescribing primarily targets initial opioid prescriptions provided for acute pain, and we observed decreases that were most pronounced among surgeons and dentists,” wrote John Cramer, MD, an assistant professor at Wayne State School of Medicine and lead author of the study published in JAMA Internal Medicine.   

Cramer and his colleagues found that state laws capping initial opioid prescriptions were associated with an average reduction of 1.7 days in supply for each Medicare patient. Prescribing also fell in states without such laws, although not as much. Despite the declines, the study concluded that “excess opioid prescribing” was still prevalent among all patient populations.

The caps on duration were imposed to reduce the initial exposure of patients to opioids, with the goal of reducing the potential for diversion, addiction and overdose. The researchers did not examine whether those goals were achieved or if patients were satisfied with their pain relief.

“Because this study used administrative data, we do not know how the patients did — was their pain adequately controlled, did they have adverse effects from the opioids, did they have trouble renewing a prescription, or continue to take opioids months later?” asked Deborah Grady, MD, and Mitchell Katz, MD, in a JAMA editorial.

Grady and Katz said it was reasonable to limit initial prescriptions to seven days, but they are concerned about imposing stricter limits on opioids.

“We worry that restricting initial prescriptions to shorter periods, such as 3 or 5 days, as occurred in 6 states in this study, may result in patients with acute pain going untreated or having to go to extraordinary effort to obtain adequate pain relief,” they wrote. “We think the data in this study suggest that limiting initial prescriptions to 7 or fewer days is helpful, but we would not restrict any further given that we do not know how it affected patients with acute pain.”

It’s not just states that have imposed limits. Some insurers and pharmacy chains have also adopted policies that put caps on first-time opioid prescriptions.

A federal bill that would have limited initial opioid prescriptions to just three days nationwide was amended earlier this year after complaints from patient advocates. The new version of the Comprehensive Addiction and Recovery Act (CARA) contains no limits on the number of days opioids can be prescribed. Congress has not acted on the bill yet.

10 Reasons for Lawmakers To Oppose Limits on Rx Opioids

By Matthew Giarmo, PhD, Guest Columnist

1. Government Leaders Have a Choice

History may record one day that politicians and policymakers had a choice: They could champion the rights of 50 million Americans in chronic pain who desperately need a hero or they could be scorned for unnecessary cruelty and playing politics with people's pain.

The gathering storm is a backlash to the heightened regulatory and surveillance culture that has commandeered our nation’s healthcare system. It will not go unanswered. We no longer allow government into our bedrooms to police sexual behavior, gender identity and abortion rights. And we sure as hell will not allow government to spy on our doctors and medicine cabinets.

The government has blood on its hands from chronic pain patients resorting to suicide and street drugs after being abandoned by physicians who fear imprisonment by DEA agents who have no medical training or patient knowledge.

2. Opioids Misunderstood

Opioids are not only cheap; they are uniquely effective in restoring quality and functionality to millions of Americans who suffer from chronic or intractable pain. Opioid medication is safe when used properly, while long term use of ibuprofen and acetaminophen is toxic.

When we examine data on efficacy, toxicity, dependency, teen use, mortality and preventable causes of death, opioids do not warrant consideration as a threat to national health security. There is no opioid "crisis" or "epidemic."

I believe any determination to the contrary is a byproduct of inappropriate agency regulation (the 2016 CDC Opioid Guideline) and biased and conflicted advice from an extremist sect (Physicians for Responsible Opioid Prescribing) operating at the fringes of the medical community. The growing realization among doctors and patients is that "the fools are in charge" and "the foxes are guarding the hen house.”

Inappropriate prescribing that resulted in spikes of opioid abuse, such as pill mills and dentists disposed to trade 60 Percocet for wisdom teeth, ended several years ago. So did the marketing of extended-release formulations like OxyContin.

3. Junk Science

You may have been seduced by contrived overdose statistics (“500,000 people died from an opioid overdose”) that remain viral, despite the CDC itself acknowledging that 48% of deaths due to illicit fentanyl were erroneously counted as deaths due to a prescription opioid.

When we break down the politically convenient and alarmist statistics into deaths involving polysubstance use, suicide, reckless dosing out of frustration with pain, and drugs that were never prescribed to the decedent, the 125 deaths per day initially claimed by the CDC looks more like 5 deaths a day.

It would be more appropriate to attribute these fatalities more to pain itself than to pain medication, as well as drug experimentation, depression or diversion. Most of those who abused OxyContin reported never having a valid script. That is no basis on which to separate chronic pain patients from their medication.

But as long as an opioid shows up in a post-mortem toxicology screen, deaths are being classified as an opioid overdose; even when the opioid was one of several drugs consumed, when it cannot be determined whether the opioid was consumed in a medically relevant way, and even when the decedent was hit by a bus.

The overdose numbers had to be gamed, which makes sense when you consider that in 70% of cases, rulings on causes of death are made before the toxicology data is even available. Especially when you consider that those sky-high opioid fatalities seem out of step with the low rates of dependency (6% for chronic pain patients, 0.7% for acute pain and less than 0.1% for post surgical pain).

As a social psychologist, government analyst and research critic, I have identified about a dozen ways the science of opioids has been corrupted for financial gain, professional survival or advancement, and in service of a political cause.

One example is the claim that “80% of heroin users first misused prescription opioids.” That canard was violently ripped from a SAMHSA report and is misleadingly used to imply that 4 in 5 patients prescribed painkillers eventually use heroin. On the contrary, less than 4% of prescription opioid users turn to heroin. 

Incidentally, 67% of heroin addicts reported that their prior use of prescription painkillers had not occurred in the past year. Hardly seems like an irresistible urge to me.

4. Not Knowing When to Say When

Much like Sen. Joe McCarthy wreaked havoc on a nation with reckless claims about communist infiltrators, opioid McCarthyism is killing our most vulnerable and innocent populations -- veterans, senior citizens, persons with disabilities and the chronically ill.

Regulations complicate and delay the dispensing of legal scripts for these patients at the pharmacy, creating a "what's-it-gonna-be-this-time" syndrome in which patients endure a new burden every month.

Prescriptions for opioid painkillers have declined 40% since 2011, while overdoses on heroin and illicit fentanyl have soared. As National Public Radio falsely reported that doctors are “still flooding the U.S. with opioid prescriptions,” solid research offers definitive evidence that prescriptive austerity is helping to drive the spike in overdose fatalities.

A recently published study found that among 113,000 patients on long-term opioid therapy, the incidence of a non-fatal overdose among those subjected to tapering was 68% higher than those who were not tapered. The incidence of a mental health crisis such as depression, anxiety or attempted suicide was 128% higher among those who were tapered.  

5. The Inherent Absurdity of MME Thresholds

Forced tapering is undertaken to achieve an arbitrary one-size-fits-all threshold that makes no sense. There is no basis in science or nature for determining how much medication is too much. As long as patients are started at the lowest effective dose and titrated up gradually, as dictated by unresolved pain and any side effects, there is no limit to how much a patient might need 5, 10 or 15 years downstream.

Arbitrary dose limits defined in terms of morphine milligram equivalents (MME) ignore the importance of individual differences in medical diagnosis, treatment history (tolerance), and enzyme-mediated (genetic) sensitivity to pain and to pain medication. MME thresholds falsely assume that all opioids are equal and impact all patients the same way.

MMEs may be convenient for bureaucrats and expedient for politicians, but their scientific utility -- and by extension the CDC guideline itself -- is nullified by differences in the half-life of different drugs, differences in their absorption into the bloodstream, and differences in their rate of metabolism in different people.

6. Without Liberty or Justice for All

For arguments sake, let us suppose that we lose as many souls to prescription opioids as we do to car accidents. What have we done to rein in this other preventable cause of death? We create laws requiring safety belts, air bags, annual inspections, and compliance with speed limits. We do not criminalize the sale, operation and distribution of Honda Civics. We do not restrict the number of cars on the road. And we do not drop DEA teams behind enemy lines in Detroit.

But at a time when Americans are growing weary with a drug war that has lasted longer than our wars in Vietnam and Afghanistan -- and when Americans have softened their views on marijuana -- the DEA, perhaps in a desperate search for new bogeymen, expanded its theater of operations to treat pharmaceutical companies as drug cartels, doctors as dealers, and patients as addicts.

As we speak, your state is creating a mini-DEA inside its Department of Health or Medical Board that weaponizes the Prescription Drug Monitoring Program as a surveillance and detection tool, to spy on and red flag each patient and doctor whose script or “NARX Score” exceeds an arbitrary limit for which no basis in science or nature exists.

Think about all the sacred ideals we’ve abandoned to support our failed effort to bring a specious “opioid crisis” under control: the Constitution; a compassionate care system that had been the cornerstone of a civilization; a physician’s right to exercise clinical judgement; their right to due process; and a system of individualized, patient-centered care.

Government is obliged to ease civil unrest -- not foment it. But federal and state governments are hell bent on driving wedges between groups of stakeholders: physicians against patients; patients and physicians against pharmacists; patients against the public at large; physicians against their own office staffs; patients against employers; and physicians against medical boards. That is McCarthyism.  

All too commonplace on social media are acrimonious altercations between the grieving survivors of overdose victims and those caring for friends or family living with chronic pain. There's no reason we can't simultaneously provide the medicine, assistance and requisite sympathy to Americans who need addiction treatment and Americans who need pain medication -- especially when we consider that only 6% of chronic pain patients prescribed painkillers develop dependency.

The NARX Score itself, a deeply flawed hotdog of a composite that ostensibly assigns a number to a person based on their supposed risk of overdose, is morally and intellectually offensive. It does little to assuage those who use the term “pain patient genocide" and compare it to the demonization and murder of 11 million Jews, gypsies, homosexuals and criminals in Germany during the Second World War.

7. Opioid Crisis As a Scapegoat

Have we as a nation become more addicted to the "opioid crisis" than we ever were to opioids? For our nation’s leaders, opioids have become an irresistible diversion and scapegoat. It’s a means to repair a tarnished reputation (see Chris Christie) or display rare bipartisan unity to disarm a cynical and frustrated constituency.

In a striking reversal of cause and effect, government officials would have you blame opioids for the loss of jobs, identities, finances and relationships that have come to define life in 21st century America. In reality, we have two crises: a crisis of chronic pain estimated to involve 50 million Americans and a psychosocial crisis linked to the combined effects of economic disparity, globalization, automation, immigration, social media, terrorism, pandemics, and the dissolution of national unity into political sects and interests.

Opioid critics like to point out that opioids only mask painful symptoms rather than address the underlying cause. But isn’t that what government officials do when they attempt to conceal or compensate for the true ills of our nation by playing whack-a-mole with prescription pain relievers?

8. The One-Track Mind

Last year a record 93,331 Americans died of a drug overdose, the vast majority involving illicit fentanyl and other street drugs, not prescription opioids.

We observed a 190% rise in cocaine overdoses and a 500% rise in overdoses involving methamphetamine. We have also seen increases in the abuse of alcohol and OTC substances like dextramorphan, diphenhydramine, ibuprofen, acetaminophen and loperamide, a drug used to treat diarrhea.

How many of those deaths can we blame on Purdue Pharma? Will collecting billions of dollars in settlement money from opioid distributors solve our overdose problem? Or will it enrich plaintiff law firms just like the Tobacco Settlement did?

9. An Unfair Fight

I was inspired to write this by a family -- MY family. I know what it’s like to see a patient’s treatment plan forcibly altered and how it affects not only the patient, but all those who cherish and depend on them. Children get less attention. Spouses assume a greater share of household responsibilities. Employers deal with lower productivity.

This memo and a lengthier report will go out to families and physicians across the country with the aid of hundreds of patient-advocate communities I mobilized on social media platforms. Still, it hardly seems like a fair fight. The meek of the Earth versus an army of federally funded Type A regulators and paid expert witnesses falling over one another to advance their careers and pad their bank accounts by making life harder for people to treat their pain.

10. Taking the Battle to the States

You may decide against reading my report, but you will likely hear about it from peers, co-workers or constituents in the months to come. It is making the rounds. State legislatures. Medical boards. Medical associations. Patient advocacy groups. Defense attorneys (I was twice asked to serve as an expert witness by physician counsel). Federal agencies.

In the past two weeks, my associates have disseminated my report to the American Medical Association, AARP, federal and state officials, members of Congress and the White House.

I invite readers to do the same by downloading my report, “There Is No Crisis.” We’re just getting started.

Matthew Giarmo, PhD, is a social psychologist who has worked with terminally ill cancer patients. Matthew authors research-based reports in social phenomena, including the impact on workforce development of the Software Revolution and Great Recession, and the degradation of science by professional and institutional requirements. 

Who Gets Rx Opioids and Who Doesn't

By Pat Anson, PNN Editor

Although opioid prescriptions in the U.S. have fallen by 40% since 2011 and now stand at their lowest level in 20 years, it’s still common to see claims that opioids are “overprescribed.”  

“Doctors And Dentists Still Flooding U.S. With Opioid Prescriptions” was the headline used by National Public Radio for an in-depth look at opioid prescribing practices.

“Public data, including new government studies and reports in medical literature, shows enough prescriptions are being written each year for half of all Americans to have one,” NPR reported in 2020. “Patients still receive more than twice the volume of opioids considered normal.”

A new study by the CDC gives some much-needed context to the myth that opioid prescriptions are flooding America. Over the past decade, the so-called flood has turned into a trickle for the vast majority of chronic pain patients – the people most in need of effective analgesia.  

The CDC study, which is based on the 2019 National Health Survey, found that only about one in five chronic pain patients – 22.1 percent – had used a prescription opioid in the past 3 months. In other words, it is “normal” for pain patients not to get opioids. 

A previous study that looked at opioid prescriptions in 2010 found that 36.4 percent of patients with chronic non-cancer pain were prescribed an opioid.  While there are differences in methodology between the two studies, the data seems to confirm that there has been a shift in prescribing practices over the past decade. Pain patients are significantly less likely to get an opioid prescription today than they were in 2010.

The new CDC study is also the first to take a deep dive into the demographic and socioeconomic characteristics of opioid recipients -- how age, sex, insurance, income, education and other factors make patients more or less likely to take opioid medication. Considering how much attention has been paid to opioid prescribing over the last decade, it’s surprising no one has looked into this before.

Researchers found that you are more likely to use prescription opioids if you are female, aged 45-64, unemployed, live in a rural area, and a Medicaid or Medicare beneficiary.  Being Black, White, a non-veteran, and living below the federal poverty level also makes you more likely to take a prescription opioid.

YOU ARE MORE LIKELY TO TAKE Rx OPIOIDS IF YOU ARE ...

SOURCE: CDC

Conversely, you are less likely to take prescription opioids if you are male, aged 18-29, employed, a military veteran, privately insured, and live in a household at least 200% above the federal poverty level. Being Hispanic, uninsured, having a college degree, and living in a large metropolitan area also makes you less likely to use opioid medication.   

YOU ARE LESS LIKELY TO TAKE Rx OPIOIDS IF YOU ARE ...

SOURCE: CDC

The CDC study did not look what type of chronic pain condition a patient had or how long they had it. It’s possible the condition itself led to someone becoming unemployed, disabled and poor, or that some other factor is at work. Military veterans, for example, have high rates of chronic pain but get fewer prescriptions because the Veterans Administration strongly discourages the use of opioids.

Researchers also relied on patient “self reports” and did not compare their answers with prescription records. Given the stigma association with opioids, it’s possible some patients may have answered “no” to opioid use, when in fact they used the drugs.

No study is without limitations, but this one shows some clear disparities between who uses opioid prescriptions and who does not. Poverty, lack of education and unemployment may have more to do with pain, drug use and “overprescribing” than policy makers and anti-opioid zealots have been willing to admit.

The Overdose Crisis Is Misunderstood

By Roger Chriss, PNN Columnist

As U.S. opioid lawsuits wind down with multi billion dollar settlements, there are increasing calls for more measures to address the overdose crisis. The calls range from further tightening opioid prescribing practices to legalizing cannabis and other drugs, all in the hope of stemming the rising tide of addiction and overdoses.

The standard view of the crisis is of a simple system, described in mechanistic terms like supply and demand or “stock and flow.” There are a handful of policy levers, and pulling on a lever will hopefully create a proportional change in the crisis.

Obviously, this approach hasn’t worked. The U.S. has reduced opioid prescribing by over 40% and seen no improvements in overdoses. By contrast, Germany is the world’s second-largest user of prescription opioids and does not have an opioid crisis.

Many U.S. states have legalized cannabis, in part as a solution to the crisis. But in the wake of cannabis legalization there are even more overdose fatalities, to such an extent that cannabis is now viewed as possibly making the opioid crisis worse.

There are also claims that prohibition is the problem and that full drug legalization is the remedy. But the legal status of tobacco and alcohol can hardly be called a public health success.

Drug abuse does not occur in a social or technological vacuum. The development of the hypodermic syringe helped morphine and heroin become street drugs, the cigarette rolling machine enabled the modern tobacco disaster, and the advent of the vape pen and synthetic cannabinoids is causing new public health problems.

The Crisis Is Not an Epidemic

All of this suggests that the current understanding of the overdose crisis is mistaken. We’ve been treating the crisis as if it were an “epidemic” caused by a single pathogen, spread through one form of transmission, and treatable with one intervention. But the overdose crisis is not an epidemic in the strict sense of the word.

Instead, it is better to think of the world of drugs as resembling a tropical country with an abundance of parasites and pathogens. Such a country is beset with viral, bacterial and fungal threats coming from a vast variety of sources. With each season the threats shift, and over the years the threats change. But they are always there, and must always be addressed.

In such a country there is no one policy lever or regulatory dial that will control outcomes. Such a country is a highly complex nonlinear dynamical landscape that is very sensitive to small changes in fundamentally unpredictable ways. Moreover, the landscape will offer up novel threats and surprises far more frequently and less predictably than intuition would suggest.

As a result, even a small change in policy can easily have unexpected effects downstream, often unintended and maybe even tragic. For instance, public health policy meant to reign in prescribing for chronic pain has impacted cancer and palliative care. And tapering patients has resulted in more mental health crises and overdoses.

This conceptual difference means that simple solutions like fentanyl test strips or urine drug testing will not end the crisis. They may help on the margins, but to expect more is to misunderstand the nature of the crisis. And even if a bold stroke does help, it only does so briefly. And then the landscape offers new challenges that must be spotted swiftly and addressed adroitly.

The world of drugs can only be managed through comprehensive efforts at prevention, monitoring and treatment with support from local communities and society at large. Countries without an overdose crisis are notable not only for doing many things the U.S. does not, but also for pursuing their efforts consistently year after year.

The overdose crisis will keep evolving as more drugs are developed and delivered to an ever-changing world of drug use. Neither lawsuits nor legalization address the core of the crisis. In the U.S. there are too many charismatic crusaders brandishing simple solutions. But in public health there are very few heroes who understand the complex nature of the problem.

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.   

Opioid Tapering Raises Risk of Overdose and Mental Health Crisis

By Pat Anson, PNN Editor

Taking a patient off opioid medication or reducing their dose – a practice known as opioid tapering – significantly raises the risk of a non-fatal overdose or mental health crisis, according to a large new study.

Researchers at University of California Davis looked at medical and pharmacy claims for over 113,000 patients on long-term opioid therapy at a dose of at least 50 morphine milligram equivalents (MME) per day. About 25% of those patients were tapered.

The study findings, published in JAMA, show that tapered patients were 68% more likely to be treated at a hospital for opioid withdrawal, drug overdose or alcohol intoxication, and they were twice as likely to have a mental health crisis such as depression, anxiety or suicide attempt.

“Our study shows an increased risk of overdose and mental health crisis following dose reduction. It suggests that patients undergoing tapering need significant support to safely reduce or discontinue their opioids.” said first author Alicia Agnoli, MD, an assistant professor at UC Davis School of Medicine. “We hope that this work will inform a more cautious and compassionate approach to decisions around opioid dose tapering.”

Agnoli and her colleagues found that patients on high daily doses who were tapered rapidly were more likely to overdose or have a mental health crisis.

“I fear that most tapering patients aren’t receiving close follow-up and monitoring to make sure they’re coping well on lower doses,” said senior author Joshua Fenton, MD, professor and Vice Chair of Research in the Department of Family and Community Medicine at UC Davis.

The UC Davis study is the largest to date to examine the impact of tapering on patients. Previous studies were generally small, poor quality or limited in scope.

“The paper is well done,” says Stefan Kertesz, MD, an associate professor at the University of Alabama at Birmingham School of Medicine, who is currently leading a study of pain patient suicides. Kertesz said it’s important to remember that people on high opioid doses are usually quite sick. Any abrupt discontinuation of therapy for them is going to be risky.

“People who have been on opioids at a relatively high dose are people who have significant risk. They have significant risk of bad things happening. Whether that’s due to the opioids or not is debatable,” Kertesz told PNN. “This is a group of people who often have high medical morbidity, high disability and high psychological vulnerability. Those risks remain after opioids are stopped or maybe become even worse.”

‘My Life Has Been Ruined’  

The 2016 CDC opioid guideline led to significant increases in tapering, as many doctors, pharmacies, insurers and states adopted its recommendation to limit opioids to no more than 90 MME a day — in many cases even smaller doses.

Three years after the guideline’s release, the Food and Drug Administration warned doctors to be more cautious about tapering after receiving reports of “serious harm in patients who are… suddenly having these medicines discontinued or the dose rapidly decreased.”   

In a recent PNN survey of over 3,600 pain patients, nearly 60% said they were taken off opioids or tapered to a lower dose against their wishes. Nearly every respondent who was tapered said their pain levels and quality of life were worse.

“My life has been ruined by the involuntary opioid medicine taper I have been forced to undergo. I spend so much more time in severe pain, in bed. I no longer can participate in most activities with friends and family. I am so unhappy,” one patient told us.

“I was force tapered to 2/3 of my pain medications. I had been on the same dosage for 8 years without problems. Eight months after being tapered, I developed AFib (atrial fibrillation) and I believe it was due to stress and anxiety of under treated pain,” wrote another patient.

“My pain management doctor tapered my meds by 80% and I had no choice but to accept it.” said another patient. “I have declined so much due to CDC Guidelines that I have become completely homebound and have lost any chance I had for quality of life.”

“I was rapidly tapered without monitoring or concern for my health, pain level, mental health or ability to function,” another patient wrote. “The CDC guideline is completely responsible for increased stigma, patient abandonment, reduced access to care, increase in disability, forcing patients to the black market and to much more affordable but dangerous heroin, and sadly to suicide because the suffering is too great.”

CDC Guideline Revision

The CDC has acknowledged its 2016 guideline caused “unintended harms” and is now in the process of revising its recommendations. But the current draft revision contains the same dose thresholds as the original guideline. That’s drawn criticism from the Opioid Workgroup, an independent panel advising the CDC on the guideline update.

“Many workgroup members voiced concern about the dose thresholds written into the recommendation. Many were concerned that this recommendation would lead to forced tapers or other potentially harmful consequences,” the workgroup said in in a report last month.

In crafting its original guideline, the CDC relied on several researchers and advisors who were critical of opioid prescribing practices. One of them is Roger Chou, MD, a primary care physician who heads the Pacific Northwest Evidence-based Practice Center at Oregon Health & Science University. Chou is not only one of the co-authors of the 2016 guideline, he’s currently involved in efforts to revise it.

As PNN has reported, Chou has numerous ties to Physicians for Responsible Opioid Prescribing (PROP), an anti-opioid activist group that publicly advocates for forced tapering. In 2019, Chou co-authored an op/ed 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.”

Chou also belonged to a state task force in Oregon that recommended a mandatory opioid tapering policy for Medicaid patients.  

“I can’t tell you whether the tapers I do in my practice are voluntary or involuntary,” Chou told The Bend Bulletin in 2019. “I don’t think there’s anything compassionate about leaving people on drugs that could potentially harm them.”

In a 2017 tweet, PROP founder Andrew Kolodny, MD, challenged the idea that anyone was being harmed by opioid tapering.

“Outside of palliative care, dangerously high doses should be reduced even if patient refuses. Where exactly is this done in a risky way?” wrote Kolodny. “I’m asking you to point to a specific clinic or health system that is forcing tapers in a risky fashion. Where is this happening?”

The UC Davis study appears to have answered Kolodny’s question. It’s happening everywhere.

“This study adds to a growing body of retrospective cohort studies that have identified harms associated with opioid tapering,” lead author Marc Larochelle, MD, wrote in a JAMA editorial that urged tapering policies be reconsidered.

“It is increasingly clear that opioid tapering needs to be approached with caution. In almost all cases, rapid or abrupt discontinuation should be avoided.”

How to Recognize and Treat Intractable Pain Syndrome

By Forest Tennant, PNN Columnist

About one year ago we launched our Intractable Pain Syndrome (IPS) Research and Education Project to bring awareness, diagnosis and treatments to persons who have this merciless condition. Much has been learned in the past year. 

Our original impetus and investigation of chronic pain revealed that some rare patients transform from a state of periodic pain to constant, never-ending pain. Once this constant intractable pain begins, patients often deteriorate, become reclusive, have a shortened life, and some may even commit suicide. Why and how this transformation occurs remained a mystery for many years. 

A major research advance in the past year is the role of autoimmunity, which is the presence of antibodies in the blood that attack one’s own tissues. Autoimmunity is so universal in IPS that we now believe that autoimmunity, plus excess electrostimulation from a disease or injury,  to be the root cause of transformation from simple chronic pain to IPS.  

Recognition of IPS 

The number one challenge in managing and controlling chronic pain is to determine if a person has transformed from simple chronic pain to IPS. Although the scientific documentation is quite sound, there is some resistance in the medical community to the discovery that chronic pain can cause a profound biologic change in multiple bodily systems. These changes may be called “alterations” or “complications,” but the fact is that a chronic pain condition can morph into IPS with cardiovascular, endocrine, and autoimmune manifestations.

The table below shows some of the differences between IPS and simple chronic pain:

The Importance of an IPS Diagnosis

The most common complaint that we receive from persons with IPS is that they can’t get enough opioid and other pain relief medications. The federal government, state medical boards, malpractice insurance carriers, and other health insurers often restrict the number of pills and dosages that can be prescribed and dispensed. As a result, many pain clinics and specialists will only do interventional procedures such as injections or implant stimulators, and will only prescribe limited amounts of opioids, if any.

In order to obtain opioids and some other drugs, particularly benzodiazepines, persons with IPS will need diagnostic tests and a specific, causative diagnosis to prove they have a legitimate medical disorder that will permit their physician to prescribe limited amounts of opioids and benzodiazepines. The major causes of IPS are:

• Adhesive Arachnoiditis

• Connective tissue or collagen disorder (Ehlers Danlos Syndrome)

• Stroke or traumatic brain injury

• Arthritis due to a specific cause

• Neuropathy due to a specific cause (CRPS, cervical, autoimmunity)

Less prevalent, but serious causes of IPS are sickle cell disease, porphyria, pancreatitis, abdominal adhesions, interstitial cystitis, and lupus. 

Your primary diagnosis will have to be validated by MRI, X-ray, biopsy, and/or photographs. Medical records must document the diagnosis. You should have a hard copy and hand-carry a set of your records to all medical appointments.

These diagnoses will not usually be acceptable to obtain opioids because they are too “non-specific” or general:

• Failed back syndrome

• Degenerative spine

• Fibromyalgia

• Central pain

• Headache

• Neuropathy.

How to Cope with Opioid Restrictions

Most local physicians are still able to prescribe two weak opioids: tramadol and codeine-acetaminophen combinations. While weak, they are better than nothing, and you may be able to build a pain control program with one or both medications.

If you have good medical records that document the causes and complications of your IPS, some medical practitioners will prescribe these opioids: 

1. Hydrocodone-acetaminophen (Vicodin, Norco) 3-4 a day 

2. Oxycodone-acetaminophen (Percocet) 3-4 a day 

3. Oxycodone alone, 2 to 3 a day

You may be able to boost the potency of opioids with what is called potentiators and surrogates. These drugs and supplements have opioid-like effects known in pharmacology as “opioid activity.” They can be taken separately between opioid dosages, or they can be taken at the same time, to make your opioid stronger and last longer.

• Kratom

• Palmitoyethanolamide (PEA)

• Cannabis/CBD

• Taurine

• Amphetamine Salts (Adderal)

• Tizanidine

• Methylphenidate (Ritalin) 

• Clonidine

• Diazepam 

• Carisoprodol

• Ketamine

• Oxytocin

Although the restrictions on opioids and benzodiazepines are perhaps unfair and an over-reach for legitimate persons with IPS, there are steps you can take to function with these restrictions.

One is to build a comprehensive, healing, and tailor-made program that will allow you to cope with fewer opioids and benzodiazepines. We’ve written previously about the importance of an IPS nutrition program. Pain relief medications are not very effective unless you have good nutrition.

There are also exercises and physical measures you can take that enhance pain control, such as walking, arm and leg stretching, water soaking, deep breathing, rocking, and gentle bouncing. Supplements can also be taken to help suppress inflammation and autoimmunity, regenerate nerve tissue and provide some pain relief.

Forest Tennant is retired from clinical practice but continues his research on intractable pain and arachnoiditis. This column is adapted from newsletters recently issued by the IPS Research and Education Project of the Tennant Foundation. Readers interested in subscribing to the newsletter can sign up by clicking here.

The Tennant Foundation gives financial support to Pain News Network and sponsors PNN’s Patient Resources section.   

Rx Drug Monitoring Programs Are Making Overdose Crisis Worse

By Pat Anson, PNN Editor

Prescription drug monitoring programs (PDMPs) have long been touted as a key weapon in the war on drugs. With the recent addition of Missouri, all 50 U.S. states now have PDMPs, allowing physicians and pharmacists to consult a database to see if patients might be abusing opioid medication or other controlled substances. Law enforcement agencies also use the databases to see if doctors are “overprescribing” opioids. 

But a new study by the Reason Foundation, a libertarian think tank, has found that PDMP’s may be making the opioid crisis worse by forcing patients to turn to street drugs. A record 93,331 Americans died of drug overdoses in 2020, with the vast majority of deaths linked to illicit fentanyl, not prescription opioids.

“This study’s analysis finds that the outcomes of PDMP implementation are far less beneficial than the popular support for this policy suggests,” the report found. “Black market overdoses from heroin and fentanyl dramatically increase following PDMP adoption. It appears that surges in illicit opioid overdose deaths follow PDMP implementation, with no clear reduction in deaths, which is the stated intent of the intervention.”   

Co-authors Jacob James Rich and Robert Capodilupo found that states reduced their opioid prescribing rates by an average of 7.7% after implementing a PDMP. But reduced prescribing had “no consistent effect” on overdose deaths. Instead, the study found strong evidence that PDMPs actually caused opioid death rates to increase by 17.5 percent. Fentanyl, heroin and cocaine overdoses all rose sharply.

“As PDMPs enable doctors to identify patients who may be doctor shopping to acquire opioids for non-medical use, doctors will likely stop prescribing opioids to them. Yet these are the very patients who are likely addicted and who will turn to illicit providers to fuel their habits,” the study found.

Percent Increase In Overdose Rates After PDMP Adoption

SOURCE: REASON FOUNDATION

‘Like Playing Russian Roulette’

A recent PNN survey of over 3,600 pain patients found that it was common for patients to be taken off opioids or tapered to lower doses against their wishes. A small minority of patients – about nine percent -- said they turned to illegal drugs as an alternative to opioid medication.

“Tapering long term higher dose patients is a barbaric practice that causes suffering so great that going to the black market for relief is the only option besides ending one’s life,” one patient told us. “People want to live so they will turn to the streets where they encounter counterfeit pills and/or much cheaper heroin, made with fentanyl. They aren't wanting to die. They are trying to live again.”

“I've had to seek medication from the black market & risk arrest & death just to be able to walk & leave my bed,” another patient wrote. “Perhaps I too will end up dead one day from street pills made from illicit fentanyl since I can't obtain access to a safe supply from a trusted manufacturer.”

“I'm not a criminal by nature, and I know that it's illegal to buy drugs off the street, but when pain gets so bad I can actually feel the desperation take over and seek relief wherever I can find it,” said another patent. “If it gets too bad I do sometimes have to find that guy on the street and purchase a 100mg morphine, or something, and just hope that it's not containing a lethal dose of fentanyl or something else. It's kinda like playing Russian roulette.”

“I couldn't stand the pain level anymore. After 3 years suffering so bad, I tried the streets. Found illegal fentanyl. The dealer said it was heroin but I found out what it really was because I overdosed and almost died,” said another pain sufferer. “I learned my lesson! Never again.”

The Reason Foundation estimates that it costs about $500,000 annually for each state to operate a PDMP. While that’s relatively inexpensive, the report said it was “counterproductive” to spend any money on a program that may actually contribute to more deaths. It recommends that states scrap their PDMPs and spend the money on addiction treatment.

“Millions of taxpayer dollars are spent nationwide on the administration of these ineffective programs each year,” the report found. “After terminating all PDMP policies, the revenue spent currently on prescribing interventions should be reappropriated to subsidizing opioids for proven treatments like medication-assisted treatment (MAT) with drugs like buprenorphine and methadone, and allowing Medicaid to cover addiction treatment services.”

Previous studies have also concluded that PDMPs may be causing more harm than good. A 2018 study found that PDMPs were driving some patients to the black market for cheap drugs like heroin. A 2019 study reached the same conclusion, saying there was a “consistent, positive, and significant association” between PDMPs and heroin overdoses.

PDMP’s are also associated with abrupt opioid discontinuation, according to a recent study in the American Journal of Preventive Medicine. Patients on long-term opioid therapy living in states with robust PDMPs were more likely to have their doses cut without tapering.

Mission Creep and the CDC Opioid Guideline

By Roger Chriss, PNN Editor

It’s been over five years since the CDC released its opioid prescribing guideline for chronic pain. Now that the agency is looking at possible revisions, it’s worth taking a close look at what research is showing about the effects of the guideline.

First, let’s revisit the goals of the 2016 guideline:

“This guideline provides recommendations for primary care clinicians who are prescribing opioids for chronic pain outside of active cancer treatment, palliative care, and end-of-life care.

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.”

That’s not what has happened in practice. Instead, the CDC guideline has impacted pain management in both cancer and palliative settings, and has impeded access to care for people with chronic painful disorders.

Cancer and Palliative Care

Several major studies have appeared this year on the effects of the CDC guideline, all finding substantial and unexpected impacts on cancer and palliative care.

An Oregon State University study of over 2,600 hospital patients discharged to hospice care showed a decrease in opioid prescribing and an increase in the use of less powerful, non-opioid analgesics. As result, “some of those patients might have been undertreated for their pain compared to similar patients in prior years.”

Similarly, a study in The Oncologist looked at cancer patients with bone metastasis, and found that opioid prescribing fell significantly between 2011 and 2017. Researchers said their findings “raise concerns about potential unintended consequences related to population-level reduction in opioid prescribing.”

And a study in the journal Cancer found that in interviews with 26 patients with advanced cancer, the majority “experienced stigma about their opioid use for cancer pain management.” Patients also reported difficulties with pharmacies and insurance coverage of opioids.

Chronic Noncancer Pain Care

In chronic noncancer pain management, the CDC guideline has had mixed effects. A recent study in JAMA Network Open concluded that guideline-based opioid prescribing “has potential to improve pain management and reduce opioid-related harms,” but never addressed whether patients thought their pain care actually improved or was even adequate.  

The guideline has also had a chilling effect on some providers. A 2019 study in JAMA Network Open found that over 40% of primary care clinics in Michigan would not accept new patients being treated with opioids due to “decreased social desirability bias.”

The American Medical Association recently reported that many pharmacists have refused to fill legitimate opioid prescriptions, with some patients being told that they were not really in pain and others being subjected to “humiliating accusations that they were drug seekers.”

The AMA shared the experience of one doctor who came back from vacation to learn that he had been blacklisted by a major pharmacy chain that would no longer fill his prescriptions for controlled substances.

“When the CDC guidelines came down in 2016 basically saying we needed to take as many people as we could off opioids, I knew that my patients were in for a world of trouble,” said Aaron Newcomb, DO. “I was particularly concerned about my patients who were stable on low-dose opioid therapy for years. And my concerns have translated into an even worse reality for both me and my patients. Getting blacklisted by a national chain who had no clue about my practice was professionally wrong, but it also hurt my patients and my community.”

The goals of the CDC guideline were laudable. Improving patient outcomes and reducing public health risks are vital to the wellbeing of society. But at least so far, it’s hard to see the CDC guideline as having achieved any of its stated goals. Instead, we have guideline creep and a worsening overdose crisis.

The CDC alone should not be blamed for this outcome. States implemented laws and regulations, in some cases before the guideline was even released, that have contributed to these unfortunate shifts in clinical outcomes. The CDC even warned about misapplication of its guideline, though to little apparent effect.

There is clearly a lot of guideline creep at work. The impacts of the CDC guideline reach far beyond the use of opioids for chronic noncancer pain and are affecting patients in unintended ways, including those suffering from cancer and terminal illnesses or recovering from surgery. Patients and providers are hopeful the upcoming revision of the guideline will address these outcomes and improve pain care.

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.  

AMA: Pain Patients ‘Need To Be Treated as Individuals’

By Pat Anson, PNN Editor

The American Medical Association is once again calling on the CDC to scrap dosage limits and make other changes to its controversial 2016 opioid prescribing guideline.

In a letter sent Thursday to a top official at the CDC’s National Center for Injury Prevention and Control (NCIPC), the chair of the AMA’s board of trustees said pain sufferers “need to be treated as individuals” and should not be subject to dose limits. The CDC is currently preparing a revision and possible expansion of the guideline, a lengthy process that could take another year to complete.

“A revised CDC Guideline that continues to focus only on opioid prescribing will perpetuate the fallacy that, by restricting access to opioid analgesics, the nation’s overdose and death epidemic will end. We saw the consequences of this mindset in the aftermath of the 2016 Guideline. Physicians have reduced opioid prescribing by more than 44 percent since 2012, but the drug overdose epidemic has gotten worse,” wrote Bobby Mukkamala, MD, a Michigan surgeon and chair of the AMA board.

The CDC said last week that a record 93,331 Americans died of drug overdoses in 2020. Although the vast majority of those deaths involved illicit fentanyl, heroin and other street drugs, efforts at combating the overdose crisis continue to focus on patients, doctors and reduced opioid prescribing.

“Patients with pain continue to suffer from the undertreatment of pain and the stigma of having pain. This is a direct result of the arbitrary thresholds on dose and quantity contained in the 2016 CDC Guideline. More than 35 states and many health insurers, pharmacies, and pharmacy benefit managers made the CDC’s 2016 arbitrary dose and quantity thresholds hard law and inflexible policy,” said Mukkamala.

“CDC’s threshold recommendations continue to be used against patients with pain to deny care. We know that this has harmed patients with cancer, sickle cell disease, and those in hospice. The restrictive policies also fail patients who are stable on long-term opioid therapy.”

The AMA has been warning about the “inappropriate use” of the guideline since 2018, when its House of Delegates adopted resolutions calling for the elimination of dose thresholds based on morphine milligram equivalents (MME). The CDC guideline recommends that daily doses not exceed 90 MME, a dose that some patients consider inadequate for pain relief.  

Recommendations a ‘Rough Guide’

At a meeting last week of the CDC Board of Scientific Counselors, one of the authors of the 2016 guideline said the MME thresholds were only meant to be “a rough guide” for prescribers and shouldn’t been seen as “absolutes.”

“We heard the concerning reports about the misapplication of the 2016 guideline and we’ve learned from what happened. We know there is a very real possibility that, even with adjustments, the guideline update could be misused,” said Deborah Dowell, MD, Chief Medical Officer of NCIPC.

Critics might wonder if the agency has learned anything in the last five years. A preliminary draft of a revised guideline still contains dose thresholds, recommending that doctors “should avoid increasing dosage to ≥90 MME/day or carefully justify a decision to titrate dosage to >90 MME/day.”

An independent panel of outside advisors that reviewed the draft expressed concern about maintaining the dose thresholds, saying they would lead to more forced tapering of patients.

“Though workgroup members recognized the need to have thresholds as benchmarks, many felt that including these thresholds in the supporting text could serve to de-emphasize them as absolute thresholds, and thus recommended removing the specific MME range from the recommendation,” the Opioid Workgroup said in its final report to CDC.

The workgroup also warned that the current draft revision of the guideline was “not balanced” because it focuses heavily on the risks and potential harms of opioids, with less attention paid to their potential benefits. The AMA called on the CDC to adopt the workgroup’s recommendations.

“Patients with pain need the CDC to be their advocate and urge it to rescind the perceived limits on opioid therapy doses or days,” Mukkamala said in closing his letter.

Opioid Income Redistribution

That view is not shared by the anti-opioid activist group Physicians for Responsible Opioid Prescribing (PROP), which sent out a news release this week claiming that prescription opioids are largely responsible for the overdose epidemic.

“Tragically, prescription opioids still account for about 28% of all opioid-related deaths.  Prescription opioids also contribute to synthetic opioid deaths because many heroin and illicit fentanyl users developed their addiction from taking prescription opioids,” PROP claimed. ”Overprescribing of opioids continues to fuel this epidemic. Reducing new opioid prescriptions remains vitally important.”

At least four PROP board members, including founder Andrew Kolodny, MD, have testified as paid witnesses for plaintiff law firms involved in opioid litigation, making as much as $725 an hour. Those law firms stand to make billions of dollars in contingency fees as those cases near an end, with one recent settlement expected to result in a $26 billion jackpot for states, cities and counties. As PNN has reported, many of the lawyers involved in the cases are major political donors.

“Businesses can’t print cash, so where do politicians think the money for these payoffs will come from? The answer is customers in higher prices and workers in lower wages,” The Wall Street Journal said in an editorial.

“The opioid settlement is another example in a growing list of lawsuits that redistribute income from the larger society to rich plaintiff attorneys, who then help politicians with their campaign contributions, who then rehire the lawyers to help with more mass tort claims. Alas, it’s the American way.”

Insomnia Drugs Risky When Taken With Opioids

By Pat Anson, PNN Editor

Medications commonly prescribed to treat insomnia significantly increase the risk of death for older adults if the drugs are taken with opioids, according to new study.

Zopiclone, zaleplon and zolpidem – collectively known as “Z-drugs” – are sold under brand names such as Ambien, Lunesta and Sonata. Z-drugs are sedative-hypnotics and act in a similar way as benzodiazepines, but are considered safer because they belong to a different class of medication.

But after reviewing the medical records of over 400,000 Medicare patients aged 65 and older, researchers at Vanderbilt University Medical Center found that Z-drugs are nearly as risky as benzodiazepines. Patients using benzodiazepines and opioids had a 221% higher risk of death from any cause, while those taking z-drugs and opioids had a 68% increased risk of dying.

Benzodiazepines such as Xanax and Valium are primarily used to treat anxiety. Until recently, benzodiazepines were often co-prescribed with opioids to pain patients, a practice that is now discouraged because both drugs suppress respiration, which can lead to an overdose.

"Our findings indicate that the risks of benzodiazepine-opioid use go well beyond the recognized hazards of overdose. They also suggest that the z-drugs, thought to have better safety than the benzodiazepines, in fact are dangerous when prescribed in combination with opioid pain medications," said Wayne Ray, PhD, professor of Health Policy at Vanderbilt and lead author of the study published in PLOS Medicine.

"Our findings add urgency to efforts to limit concurrent prescribing of benzodiazepines and opioids. They also suggest that targeted warnings are needed to advise older patients and their providers regarding the potential risks of taking z-drugs with opioids."

Last year the Food and Drug Administration ordering drug manufacturers to update warning labels for benzodiazepines to strongly caution patients and providers about the risk of abuse, addiction, dependence and overdose, particularly when the drugs are used with opioids or alcohol.   

In 2019, the FDA also ordered stronger warning labels for Z-drugs, but in that case it was to caution people about rare side effects such as sleepwalking, sleep driving and other risky behaviors.  

CDC Advisory Panel Warns Revised Guideline Ignores Benefits of Opioids

By Pat Anson, PNN Editor

An independent advisory panel is warning the CDC that a draft revision of its 2016 opioid guideline is focused too heavily on the risks of taking opioid medication, with not enough attention paid to the benefits that opioids have for many pain patients.

A 12-page report from the CDC’s Opioid Workgroup was discussed Friday during an online meeting of the agency’s Board of Scientific Counselors (BSC). The 23-member workgroup is composed primarily of physicians, academics and researchers involved in pain management, including some who advised the agency during the drafting of the original guideline.

CDC has not made public the revised draft guideline and has no plans to release it for public comment until later this year. The workgroup, however, has seen the draft and many of its members have issues with it.     

“Overall, many workgroup members felt that much of the supporting text of the guideline was not balanced and was missing key studies. Many workgroup members felt that the guideline focused heavily on the risks or potential harms of opioids, while less attention was focused on the potential benefits of opioids, or the risk of not taking opioids or undertreating pain,” the workgroup report states.

“Many workgroup members noted how the guideline has a constant tension between public health benefits versus patient benefits. This issue is minimally addressed in the guideline and comes very late. Workgroup members felt it is important to directly address this tension between risks and benefits to public health versus individual patients.”

Although voluntary and only intended for primary care physicians treating chronic pain, the 2016 guideline’s recommended dose limits for opioids were quickly adopted as policy by many states, insurers, law enforcement, pharmacies and doctors of all specialties.

As a result, many pain patients who took opioids safely for years were cutoff or tapered to lower doses. Many new patients who need pain relief can’t even get opioids because their doctors refuse to prescribe them. Opioid prescriptions have fallen to their lowest level in 20 years, but drug deaths continue rising.

Not until 2019 did the CDC publicly acknowledge the “misapplication” of the guideline and promise to make changes – although the process is unfolding slowly. The newly revised guideline is not expected to be released until late 2022.

“We heard the concerning reports about the misapplication of the 2016 guideline and we’ve learned from what happened. We know there is a very real possibility that, even with adjustments, the guideline update could be misused.”

— Dr. Deborah Dowell, CDC

“We heard the concerning reports about the misapplication of the 2016 guideline and we’ve learned from what happened. We know there is a very real possibility that, even with adjustments, the guideline update could be misused,” said Deborah Dowell, MD, Chief Medical Officer of the CDC’s National Center for Injury Prevention and Control (NCIPC), who co-authored the original guideline.

Dowell gave a brief outline of the guideline update to the BSC, noting that it’s recommendations are being expanded beyond chronic pain to include acute pain (pain lasting less than one month) and sub-acute pain (pain lasting 1 to 3 months).

She also disclosed the names of the five co-authors who are writing the update, briefly showing their names on a slide. They include Dowell herself, Kathleen Ragan, a CDC Health Scientist; Christopher Jones, PharmD, Acting Director of NCIPC; Grant Baldwin, PhD, Director of Overdose Prevention at NCIPC; and Roger Chou, MD, Director of the Pacific Northwest Evidence-based Practice Center at Oregon Health & Science University (OHSU), which has received billions of dollars in research funding from the federal government.

The inclusion of Chou as an update co-author is likely to be controversial. As PNN has reported, Chou has been an outspoken critic of opioid prescribing and has numerous ties to Physicians for Responsible Opioid Prescribing (PROP), an anti-opioid activist group. Like Dowell, Chou was a co-author of the 2016 guideline.

“It is wildly inappropriate and unethical that someone with strong ties to the anti-opioid industry and who has significant financial conflicts of interest is leading this process,” Amy Partridge, an intractable pain patient, told the BSC. “The evidence review and guidance are therefore both inherently biased and should be struck in their entirety.”

Chou — who is a member of the BSC — acknowledged he has a conflict of interest at the start of the meeting and recused himself. “I do have a conflict. I receive funding to conduct reviews on opioids, and I'll be recusing myself after the director's update,” said Chou.

Chou’s recusal apparently only applied to his participation in the meeting, not to his continuing involvement in the guideline update or OHSU’s research.

Dose Recommendations Questioned

Some members of the Opioid Workgroup feel the current draft of the update is “not sufficiently patient-centered,” while others believe not enough attention was paid to disparities in pain care and lack of access to effective, non-opioid treatments.

One of the biggest issues for the workgroup is the revised guideline’s recommendation that initial opioid doses be limited to 50 morphine milligram equivalents (MME) per day and not be increased above 90 MME, which is essentially unchanged from the 2016 guideline. The workgroup believes the dose thresholds are arbitrary, based on poor evidence and should be “de-emphasized.”

“Many workgroup members voiced concern about the dose thresholds written into the recommendation. Many were concerned that this recommendation would lead to forced tapers or other potentially harmful consequences. Though workgroup members recognized the need to have thresholds as benchmarks, many felt that including these thresholds in the supporting text could serve to de-emphasize them as absolute thresholds, and thus recommended removing the specific MME range from the recommendation,” the report found.

Dowell said the MME thresholds are only meant to be “a rough guide” and shouldn’t been seen as “absolutes.”

“We certainly are looking at language in the guideline and also looking at feedback about how to better communicate those nuances and their flexibility,” she told the BSC.

Worries About ‘Bad Policy’

Several workgroup members have issues with the recommendation that non-opioid therapies be used for “many common types of acute pain,” because it doesn’t distinguish between post-surgical pain that may require opioids and other types of short-term trauma that could be treated with non-opioid pain relievers. They warned the recommendations for treating acute pain “could be misinterpreted and translated into bad policy.”

The workgroup also took issue with recommended drug testing for anyone prescribed opioids for chronic pain. Their report says false results from urine drugs tests are common and could have “inappropriate negative consequences” for patients, while more accurate and expensive laboratory tests may not be covered by insurance.

Questions were also raised about prescription drug monitoring programs (PDMPs), particularly the use of algorithms and data mining to create risk scores for patients based on their drug history.

It's important to note that the workgroup’s role is strictly advisory. It had no direct role in writing the revised guideline and will not be involved in rewriting it, if changes are even made.

You can watch most of the meeting below (video courtesy of Peter Pischke):

The workgroup’s report drew both criticism and praise during the public comment period. Some speakers believe the guideline can’t be fixed and should be repealed.

“No matter the intent, goal or method that the CDC may desire with these guidelines and their purpose in the American healthcare system, the DEA will still manipulate them to serve their way,” said Margaret Rene Blake, a pharmacist and intractable pain sufferer. “As long as they exist, they can and will be misapplied. The way to stop the harm to patients, providers and the system is to repeal the guideline.”

One critic suggested the workgroup volunteers, who were unpaid, were swayed by the pharmaceutical industry.

“The OWG (Opioid Workgroup) comments perpetuate myths disseminated by opioid manufacturers. Claiming that the guideline focused heavily on the risks or potential harms of opioids, while less attention was focused on the potential benefits is certainly an industry friendly view,” said Adriane Fugh-Berman, MD, Director of PharmedOUT and a PROP board member, who was a paid expert witness in Oklahoma’s lawsuit against opioid manufacturers.

“Several statements in the OWG (report) are just wrong, including the claim that continuing and not tapering opioids avoids risks of poor analgesia, worsening function and suffering.”

Without seeing the revised draft guideline in its entirety, it’s hard to tell if any significant changes have been made to the original guideline. But judging from the workgroup’s report, the changes have been minor so far. The draft guideline continues to maintain that “nonopioid therapies are preferred” for both short and long-term pain, and that doctors should only consider opioids “if expected benefits for pain and function are anticipated to outweigh risks to the patient.”

There is also no indication what the CDC intends to do to persuade states, insurers, pharmacies, doctors and other federal agencies that they should amend opioid policies and laws that are based on the 2016 guideline.

Ending the War on Drugs Probably Won’t Help Pain Patients

By Roger Chriss, PNN Columnist

America’s war on drugs has been running for half a century and calls to bring it to an end are increasing. Lawmakers and public health experts are questioning federal and state policies that criminalize drug use, while the public generally supports less punitive measures to address drug abuse and addiction.

"The war on drugs must end,” said a recent editorial in The Lancet. “Decriminalisation of personal drug use, coupled with increased resources for treatment and harm reduction, alongside wider initiatives to reduce poverty, and improve access to health care, could transform the lives of those affected."

But ending the war on drugs probably won’t help people with chronic painful conditions. That’s because decriminalization of recreational drugs is not necessarily associated with full legalization – as is the case with marijuana -- while legalization of recreational drugs is separate from medical care with pharmaceutical prescriptions.

The debate about how to end the drug war is largely ideological at this point. In the new issue of The American Journal of Ethics, Carl Hart, PhD, author of the book “Drug Use for Grown Ups,” writes with colleagues that laws criminalizing drug use are “rooted in explicit racism.”

"We call for the immediate decriminalization of all so-called recreational drugs and, ultimately, for their timely and appropriate legal regulation," they wrote.

But bioethicist Travis Rieder, PhD, author of the book “In Pain” about his experience with opioid-based pain management, wrote in the same journal that “ending the war on drugs does not require legalization, and the good of racial justice and harm reduction can be achieved without legalization.”

Yet another view comes from Stanford psychiatrist and PROP board member Anna Lembke, MD, who wrote in the Journal of Studies on Alcohol and Drugs that creating a “safe supply” of drugs by legalizing the non-medical use of prescription medication would be a mistake.

“The expanded use of controlled prescription drugs should not occur in the absence of reliable evidence to support it, lest we find ourselves contending with a worse drug crisis than the one we’re already in. No supply of potent, addictive, lethal drugs is ‘safe’ without guarding against misuse, diversion, addiction, and death,” said Lembke.

The Lancet points to Portugal as an example that other countries should follow. But contrary to common belief, Portugal has not legalized drugs. In Portugal, drug possession of no more than a ten-day supply is an administrative offense handled by so-called dissuasion commissions.

Portugal has not even legalized recreational cannabis. Medical cannabis is legal in Portugal, but only when prescribed by a physician and dispensed by a pharmacy if conventional medical treatments have failed. Personal cultivation of cannabis remains against the law.

Further, neither decriminalization nor legalization necessarily improves racial and social justice. For instance, the University of Washington’s Alcohol & Drug Abuse Institute reports that the legalization of cannabis in Washington state in 2012 has had no impact on reducing racial bias in policing and other disparities in the criminal justice system.

Broad drug decriminalization or legalization would likely have little impact on pain management. Healthcare professionals routinely prescribe medications that are illegal outside of clinical medicine, after weighing the risks and benefits for each patient. Patients are often monitored via pain contracts and drug testing, with some agreements even disallowing cannabis and restricting alcohol use for patients taking medications like opioids or benzodiazepines.

Physicians and pharmacies are under increasing scrutiny from law enforcement, insurers and regulators in the hope of curbing drug abuse. If decriminalization or legalization of drugs leads to more abuse, addiction and overdose, then the scrutiny could increase. So in an unexpected way, an end to the war on drugs could have negative impacts on pharmacological pain management.
 
Supporting an end to the war on drugs is a right and just action. But it would be a mistake to assume that an end to that war will necessarily bring a positive change to pain management. For that, it would be better to support physician autonomy and greatly expanded clinical research into pain management.

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.