Is DEA Practicing Medicine Without a License?

By Pat Anson, PNN Editor

Tomorrow the U.S. Drug Enforcement Administration holds another Prescription Drug Take Back Day, a campaign that encourages people to help combat drug addiction and overdoses by disposing of their unneeded medication at thousands of drop-off locations nationwide.

It’s also a day the DEA uses to further stigmatize the prescription drugs that millions of Americans rely on to control their pain and have functional lives.

“The majority of opioid addictions in America start with prescription pills found in medicine cabinets at home. What’s worse, criminal drug networks are exploiting the opioid crisis by making and falsely marketing deadly, fake pills as legitimate prescriptions, which are now flooding U.S. communities,” DEA Administrator Anne Milgram said in a statement. “I urge Americans to do their part to prevent prescription pill misuse: simply take your unneeded medications to a local collection site.”

The DEA’s campaign to reduce the supply of opioid medication goes well beyond drug take back days. In 2022, the agency is planning to cut production quotas for oxycodone, hydrocodone and other widely used opioid pain relievers. If the proposed quotas published this week in the Federal Register are adopted – and past history indicates they will be – it’ll be the sixth consecutive year the DEA has reduced the supply of opioid medication. 

During that period, production quotas have fallen by 63% for oxycodone and 69% for hydrocodone. And opioid prescribing has fallen to levels not seen in 20-years.

But with drug overdoses climbing to record highs, critics say there is no evidence the DEA’s strategy is working. And they are alarmed that a law enforcement agency is setting policies that affect the healthcare choices of Americans -- in effect, practicing medicine without a license.

“I think a very strong argument can be made that DEA is inappropriately exercising medical judgment based on their reasoning for supporting another production reduction for opioid analgesics,” says Dr. Chad Kollas, a palliative care specialist in Florida. “Federal policy has encouraged blind reductions in opioid prescribing, so for DEA to cite that trend as evidence for a reduced need for the medical supply of opioid analgesics is a self-fulfilling prophecy.

“Reduced prescribing has not led to a reduction in overdose deaths involving opioids, but rather has been associated with an increase in overdose deaths and suicides in patients with chronic pain who have been forced off their pain medications. Federal opioid policy calling for non-focused, reduced opioid prescribing has been an abject failure.” 

18.88% Decline in ‘Medical Need’

Under federal law, the DEA is required to annually set production quotas for opioids and other controlled substances. It does so after consulting with the Food and Drug Administration, Centers for Disease Control and Prevention, and other federal agencies to establish the amount of drugs needed for medical, industrial and scientific purposes.  

"The responsibility to provide these estimates of legitimate medical needs resides with FDA. FDA provides DEA with its predicted estimates of medical usage for selected controlled substances based on information available to them at a specific point in time in order to meet statutory requirements,” DEA explained in the Federal Register.

“With regard to medical usage of schedule II opioids, FDA predicts levels of medical need for the United States will decline on average 18.88 percent between calendar years 2021 and 2022. These declines are expected to occur across a variety of schedule II opioids including fentanyl, hydrocodone, hydromorphone, oxycodone, and oxymorphone."

Asked to comment on the DEA’s statement, an FDA spokesperson said the agency sent a letter to the DEA in April 2021 using pharmaceutical sales data from prior years to create “statistical forecasting models to estimate medical need for the next two years.” The FDA letter never actually used the 18.88% estimate, that was a figure apparently calculated by the DEA itself.

“In the letter FDA provided an estimate for need of each individual active ingredient in various opioid medications for 2021 and 2022. It appears the DEA estimated the 18.88% decrease as an average across the list of opioid active ingredients, presumably based on the estimates we provided.  We do not disagree with their forecast for this decreasing trend of opioid need,” the FDA spokesperson wrote in an email to PNN.

Opioid ‘Red Flags’

In its statement in the Federal Register, DEA also said it relies extensively on data from prescription drug monitoring programs (PDMPs) to find “red flags” that may indicate a drug is being abused or diverted. The DEA is particularly concerned about daily opioid doses that exceed 240 morphine milligram equivalents (MME). That’s a very high dose for most people – and well above the CDC opioid guideline’s recommended limit of 90 MME.

“DEA believes that accounting for quantities in excess of 240 MME daily allows for consideration of oncology patients with legitimate medical needs for covered controlled substance prescriptions in excess of 90 MME daily. Higher dosages place individuals at higher risk of overdose and death. Numerous dispensings of prescriptions with dosages exceeding 240 MME daily may indicate diversion such as illegal distribution of controlled substances, or prescribing outside the usual course of professional practice,” the DEA said.

Where does the 240 MME threshold come from? That’s apparently another case of the DEA coming up with its own estimates to determine whether a dose is medical necessary. It certainly doesn’t come from the CDC guideline, which was never meant to include patients suffering from cancer pain or those in palliative care.

“The DEA is misapplying the CDC opioid guidelines, which were explicitly not meant to apply to patients receiving palliative care,” Dr. Kollas told PNN. “Moreover, it’s disingenuous for DEA to infer that patients receiving higher doses of opioid analgesics are diverting them, when the vast majority of opioid overdose deaths arise from illicit fentanyl in counterfeit pills.”

Just how serious is the drug diversion problem? Not so serious at all, according to the DEA’s own National Drug Threat Assessment, an annual report that for years has said that less than 1% of legally prescribed opioids are diverted.  

“The number of opioid dosage units available on the retail market and opioid thefts and losses
reached their lowest levels in nine years,” the DEA’s 2020 report found.

The same report also found that illicit fentanyl, not prescriptions opioids, is “primarily responsible for fueling the ongoing opioid crisis.” That’s a view shared by the American Medical Association, which declared in 2020 that “the nation no longer has a prescription opioid-driven epidemic.”

‘Stop Punishing Pain Patients’

If that makes you wonder why the DEA is so intent on further reducing the supply of opioids, you’re not alone.

“This is pure insanity. The scientific data from the CDC & NIH (National Institutes of Health) show that the overdose crisis is NOT due to prescription opioid analgesics,” wrote Chuck Robertson, one of hundreds who left comments in the Federal Register on the DEA proposal. “We are in the midst of the worst supply chain crisis in modern history, so you want to continue to cut back on production? All this is doing is putting hospitals and pharmacies at risk of being short medications that people need to control pain.”

“Please don’t cut production quotas of the opioids listed. There are hundreds of stories of people who need opioid medication therapy to even live at the most basic of functionality,” said Michelle Stifle, a chronic pain patient for 22 years. “This inhumane treatment is discriminatory. Stop punishing pain patients for the faults of others.” 

“Please do not cut the quotas anymore. My wife has several autoimmune diseases that cause horrible pain. She was completely cut off of her pain meds after almost 20 years of use,” said Jeffrey Smith. “She never took more than prescribed and never abused them. It allowed her to live somewhat normally. Now she suffers every day and has no life. I'm afraid the time is coming she won't be able to take the pain anymore.” 

“I was forced tapered off my pain meds after taking them responsibly for 17 years. I now spend 75 percent of time in bed. I cannot function and am in constant pain,” said Shelly Allen. “I recently tore my rotator cuff and couldn't even get a few days’ worth. Where there may have been overprescribing there is now underprescribing. It's my body, why can't I choose my own pain relief in reasonable doses?”

“We don't need more cuts to the supply of opiates. It doesn't help avoid addiction or address it. All cutting the supply further will do is promote health care rationing,” wrote Amber Smith. “Opiates are necessary for surgery and other medical needs. Would the DEA ever suggest cutting the supply of chemotherapy or insulin? No, yet those are every bit as necessary to patients as opiates are.”

The DEA did not respond to a request for comment on this story. To leave your comment on the DEA’s proposed 2022 production quotas, click here. Public comments must be received by November 17.

The Rx Opioid Most Likely To Be Misused May Surprise You

By Pat Anson, PNN Editor

For well over a decade, addiction treatment providers and public health officials have been touting the benefits of buprenorphine, an opioid that can treat both pain and addiction. When combined with naloxone in drugs like Suboxone that treat opioid use disorder (OUD), buprenorphine reduces cravings for opioids and lowers the risk of abuse.    

But a new study published in JAMA Network Open suggests that someone is far more likely to misuse buprenorphine than other opioids. In fact, the misuse rate for buprenorphine is over two times higher than misuse rates for hydrocodone, oxycodone and other opioid pain medications.

Researchers at the National Institute on Drug Abuse and the Centers for Disease Control and Prevention conducted the study, looking at data from nearly 215,000 people who participated in the National Surveys on Drug Use and Health from 2015 to 2019.

Respondents were asked if they misused prescription opioids “in any way that a doctor did not direct you to use them.” If they used someone else’s prescription or took opioids in greater amounts or more often than they were told by a doctor, that was considered “misuse.”

Researchers crunched the numbers and found that the vast majority of people do not misuse opioid pain medication and take it as directed. Oxycodone, for example, was misused by 12.7% of respondents who took it, followed by hydromorphone (11.8%), hydrocodone (11.6%), and prescription fentanyl (11.5%). Tramadol (7.8%) was misused the least.  

Addiction treatment drugs were misused the most. Buprenorphine was misused by 29.2% of the people who took it, followed by methadone at 22.2 percent. It’s not uncommon for someone getting OUD treatment to have relapses, so perhaps that finding is not altogether surprising.

% MISUSE RATES FOR PRESCRIPTION OPIOIDS

SOURCE: JAMA NETWORK OPEN

Although buprenorphine is misused at a rate over two times higher than other opioids, researchers chose to focus on the positive: a recent downward trend in buprenorphine misuse, despite increases in the number of patients receiving buprenorphine treatment.

“In 2019, nearly three-fourths of US adults reporting past-year buprenorphine use did not misuse their prescribed buprenorphine, and most who misused reported using prescription opioids without having their own prescriptions. These findings underscore the need to pursue actions that expand access to buprenorphine-based OUD treatment, to develop strategies to monitor and reduce buprenorphine misuse,” researchers concluded.

What Is Misuse?

Every study has its flaws, and this one is no exception. Findings based on self-reported survey results are subject to poor memories, recall bias and concerns about stigma. The researchers’ broad definition of “misuse” could also result in a diagnosis of OUD when none actually exists, according to a pain management expert.

“It is not really clear what any of the data means clinically because of the very broad definition of the word misuse,” said Lynn Webster, MD, Senior Fellow at the Center for U.S. Policy (CUSP) and Chief Medical Officer of PainScript. “Behavior of taking an extra pill to control pain, despite it not being specifically directed by the prescribing provider, could be described as ‘misuse.’ This is not necessarily harmful, even if it is inappropriate. The implication is that simply taking an additional pill is an indication of OUD behavior. That would not be an appropriate characterization of the behavior. 

“In fact, the authors report the most common reason to misuse medication is to relieve pain in the OUD and non-OUD groups. This may imply that most people who are misusing their medications are experiencing undertreated pain.” 

The JAMA study is not the first to report a high rate of buprenorphine misuse. The DEA’s 2020 National Drug Threat Assessment reported that buprenorphine is misused more often than methadone or hydrocodone, and that it was poised to replace oxycodone as the most commonly misused prescription opioid. Unlike the JAMA study, the DEA said the misuse of buprenorphine was increasing, not declining.   

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.”

Researchers Warn of Deadly New Illicit Opioid

By Pat Anson, PNN Editor

A new illicit opioid that is 20 times more potent than fentanyl has been linked to at least eight fatal overdoses in the U.S. in the last month, according to a public safety alert released by a Pennsylvania research laboratory.

The Center for Forensic Science Research & Education (CFSRE) said its scientists detected N-pyrrolidino etonitazene -- also known as etonitazepyne -- in eight blood samples taken during recent death investigations in West Virginia, Pennsylvania, New York, Florida and Colorado.  Four of the deaths occurred in West Virginia.

“The toxicity of N-pyrrolidino etonitazene has not been examined or reported but recent association with death among people who use drugs leads professionals to believe this synthetic opioid retains the potential to cause widespread harm and is of public health concern. Identifications of N-pyrrolidino etonitazene have also been reported recently from agencies in Europe,” the safety alert said.

Etonitazepyne is a synthetic opioid that is chemically similar to etonitazene, another powerful narcotic that started appearing in illicit drug markets and counterfeit pills in the U.S. and Canada last year.  While etonitazene is classified as an illegal Schedule I controlled substance by the DEA, etonitazepyne has not specifically been scheduled. Several websites even list it for sale for “chemical research.”

"The current drug landscape in the United States is unstable and unpredictable – especially the opioid market – which can ultimately lead to deadly outcomes," said Dr. Alex Krotulski, an associate director at CFSRE. "The purpose of this public alert is to raise awareness about a new and already deadly synthetic opioid so that way people who use drugs are able to modify use patterns and so that laboratories know to test for this new drug in their states or jurisdictions.”

Etonitazepyne may be new to law enforcement, coroners and public health officials, but illicit drug users have been warning each other about the drug for several months in online message boards.

“I got a report about an overdose with only 1 MG of Etonitazepyne (snorted) that caused a pretty high tolerance user to become unconscious and stopped breathing, and he had to be rescued from paramedics,” a poster said on Reddit.

“Everyone needs to be careful with this one. It's not for anyone who has no tolerance to opioids, and can still be dangerous for those who do,” another poster wrote.

Addiction Is the Problem, Not Pain

By Carol Levy, PNN Columnist

The war on drugs always seems to target pain sufferers. We are the number one example of what happens when someone is given opioids. We are the villains, our pain the “gateway” to addiction -- a fiction that no one seems able to dispel, regardless of the evidence and common sense.

Why are we the bad guys? Is it because we are the easiest to single out?

Maybe.

I was watching an episode of the old TV show “ER.” One of the main characters, Dr. John Carter (Noah Wyle), was stabbed repeatedly by a psychotic patient. His pain was horrendous, his need for opioids obvious. Dr. Carter survived the attack, but became addicted. In one scene, he even goes to the extreme of injecting himself with fentanyl.

I began to recall other shows where the plot was the same: injury, opioids to manage the acute pain, and then full-blown addiction.

In an episode of “The Golden Girls,” Betty White's character, Rose Nyland, discloses she was addicted to pain pills. She started taking them 30 years earlier after she injured her back. Her doctor never told her to stop taking them, so she continued using opioids for decades. It was her secret until her roommates figured it out.

It is a shame that TV shows like these don’t include a disclaimer: These characters had acute pain, not chronic. Most people with chronic pain do not become addicted.

It’s a common belief that if you have acute or chronic pain and are given opioids that you will probably become addicted. But has anyone ever studied the two types of pain and their rates of addiction?

I Googled it using the words "chronic pain and addiction vs acute pain and addiction." There were no studies that directly compared the two. The results were either about chronic pain and addiction, or acute pain and addiction. I changed the search terms to “acute pain, opioids, addiction rates.” The results were the same.

Why hasn't anyone looked into the differences in addiction in these two very dissimilar populations?

Why has no one done studies with a population of acute pain patients who became addicted after an injury or surgery? Then compare those rates with chronic pain patients who become addicted?  If they have, I wasn’t able to find them.

Are chronic pain patients being villainized because we are the most visible population?

It is always easier to go after the most desperate and the most vulnerable -- and when it comes to opioids and managing pain, we fit the bill. We will continue to be the bogeyman in the “opioid crisis” until this changes.

Carol Jay Levy has lived with trigeminal neuralgia, a chronic facial pain disorder, for over 30 years. She is the author of “A Pained Life, A Chronic Pain Journey.”  Carol is the moderator of the Facebook support group “Women in Pain Awareness.” Her blog “The Pained Life” can be found here.

Patients in Addiction Treatment Often Stigmatized by Doctors

By Pat Anson, PNN Editor

Most chronic pain patients are well aware of the stigma associated with using opioids. A recent PNN survey of over 3,600 pain sufferers found that about a third had been abandoned by a doctor (29%) and many were unable to find a new physician to treat their pain (36%).

“I was abandoned by the doctor who did my last operation,” a veteran with CRPS told us. “I should have been put on whatever pain medication possible to ease my pain. I wasn't. I'm not a drug addict and I damn sure don't appreciate being treated like one!”

“The stigma and refusing to treat needs to be addressed. Stigma by pharmacists, doctors and society is cutting life short. Patients have become social pariahs. Severe surgeries are conducted and patient is sent home with Aleve. It’s barbaric, cruel and inhumane,” another patient said.

The stigma also extends to people being treated for opioid use disorder (OUD), according to a new study of patients in the Canadian province of Ontario. Researchers at St. Michael's Hospital in Toronto analyzed the health records of nearly 155,000 patients who were discharged by a primary care physician between 2016 and 2017.

The research findings, recently published in PLOS Medicine, found that patients prescribed an addiction treatment drug such as Suboxone or methadone were 45% less likely to find another primary care provider (PCP) in the next year compared to other patients.

"There are considerable barriers to accessing primary care among people who use opioids, and this is most apparent among people who are being treated for an opioid use disorder. This highlights how financial disincentives within the healthcare system, and stigma and discrimination against people who use drugs introduce barriers to high quality care," said lead author Tara Gomes, PhD, a researcher at St. Michael’s Li Ka Shing Knowledge Institute.

"Ongoing efforts are needed to address stigma and discrimination faced by people who use opioids within the health care system, and to facilitate access to high quality, consistent primary care services for chronic pain patients and those with OUD.”

Surprisingly, Gomes and her colleagues found that pain patients on long-term opioid therapy in Ontario did not have a harder time finding a new PCP. That finding is at odds with a recent study in the United States, which found that nearly half of primary care practices would not accept new patients who were already taking opioids.

Researchers think the discrepancy may be due to the U.S. having a private healthcare system, where there is a financial incentive to drop patients with complex health needs, as opposed Canada’s publicly funded healthcare system.

During the gap in their primary care coverage, about 5% of Ontario patients on long-term opioids visited an emergency room, suggesting that the loss of a PCP led to further health problems that made them seek care in a hospital. In effect, patient abandonment not only made those people sicker, it shifted the financial burden of their healthcare to someone else.

“Although the structure of primary care differs across North America, our findings suggest that even in a province with a publicly funded healthcare system that has undergone considerable primary care transformation, barriers to care continue to exist for people who use opioids, particularly those with an OUD,” Gomes wrote.

The researchers said insurance reimbursement policies should be reviewed to ensure that they do not lead to the discrimination and stigmatization of patients. Doctors should also be educated on how abandoning or discharging patients can be harmful.

Patient abandonment may have grown worse since Canada adopted a new opioid prescribing guideline in 2017. A 2019 survey of patients by the Chronic Pain Association of Canada found that about a third of patients had either been abandoned by a doctor or their doctor refused to continue prescribing opioids to them.

Overdose Crisis Linked to Poor Mental Health

By Pat Anson, PNN Editor

A comprehensive new study has found that stress and anxiety are key drivers in the U.S. overdose crisis, with poor mental health increasing the risk of dying from a drug overdose by as much as 39 percent.

"We saw a strong association with mental health and substance abuse disorders, particularly opiates," says co-author Diego Cuadros, PhD, an epidemiologist who directs the University of Cincinnati’s Health Geography and Disease Modeling Laboratory. "What's happening now is we're more than a year into a pandemic. Mental health has deteriorated for the entire population, which means we'll see a surge in opiate overdoses."

Cuadros and his colleagues looked at overdose deaths and socioeconomic data in the U.S. from 2005 to 2017, and identified 25 “hot spots” or sub-epidemics where there was a sizeable increase in drug deaths. In the Southwest, sub-epidemics were driven by methamphetamine and heroin, while overdoses in the Northeast and Midwest were first fueled by heroin, then prescription opioids, and now synthetic opioids such as illicit fentanyl.

U.S. Overdose “Hot Spots”

PLOS ONE

While different substances were often involved in sub-epidemics, researchers say the one thing they all had in common was high levels of physical and mental distress.

"This is a complex epidemic. For HIV we have one virus or agent. Same with malaria. Same with COVID-19. It's a virus," Cuadros said. "But with opioids, we have several agents. At the beginning of the epidemic it was heroin. By 2010 it switched to prescription opiates."

Deaths of Despair

The study, published in PLOS ONE, builds on the so-called “deaths of despair” theory that was first described in 2015 by Princeton researchers Anne Case and Angus Deaton, who found that the reduced life expectancy of middle-aged white Americans was linked to substance abuse, unemployment, limited education, divorce, depression and loss of social connections.

The new study found that young white males aged 25 to 29 were most at risk of a fatal opioid overdose, followed by white males aged 30 to 34. In recent years, they were joined by black males aged 30 to 34 who also have an elevated risk of dying from an overdose. Those age groups do not fit the typical profile of a pain patient on prescription opioids, who is usually older and has an age-related disability such as arthritis.

“For the past 20 years, seniors over age 62 have had the highest rates of doctor-prescribed opioid pain relievers, while sustaining the lowest and mostly stable rates of opioid overdose related mortality. During the same period, overdose mortality more than tripled among adults age 25 to 34, who receive far fewer prescriptions than seniors,” says Richard “Red” Lawhern, PhD, a patient advocate who has long argued that the demographics of the overdose crisis prove it is not being driven by opioid medication. 

“Drug abuse and addiction are instead driven by complex socio-economic factors that some investigators have called ‘a crisis of hopelessness.’ Structural unemployment and poverty have rendered some populations more vulnerable to drug abuse than others,” said Lawhern.

“Hot spots of high mortality occur primarily in rural counties of the Rust Belt, deep South and West, with a sprinkling in inner cities also paralyzed by poverty. Communities are being hollowed out and families are failing due to a national failure to invest to replace infrastructure and mining jobs formerly held by high school educated men.”   

A notable holdout in the “deaths of despair” theory is Andrew Kolodny, MD, an addiction treatment specialist and longtime critic of opioid prescribing who is the founder of the newly renamed Health Professionals for Responsible Opioid Prescribing (PROP).

“The vast majority of drug overdose deaths are occurring in people with the disease of opioid addiction, not necessarily people who are drinking or using drugs driven by socioeconomic factors,” said Kolodny in a recent webinar. “The deaths of despair framing, while provocative, is unlikely to explain the main sources of the fatal drug epidemic and that efforts to improve economic conditions in distressed locations, while desirable for other reasons, are not likely to yield significant reductions in drug mortality.”

Kolodny is not an economist, epidemiologist or pain management specialist. He is a well-paid expert witness in opioid litigation cases – lawsuits that depend on a public narrative that excess opioid prescribing, not mental health problems, led to the addiction and overdose crisis. Maintaining that narrative is becoming harder, with opioid prescribing in the U.S. at 20-year lows and overdose deaths at record highs, fueled in part by economic and social issues exacerbated by the pandemic.

In other comments during the webinar, Kolodny said the CDC’s 2016 opioid guideline was “a bit wishy washy” because it only said that opioids were not the preferred treatment for chronic pain. Kolodny said a Department of Veterans Affairs and Department of Defense guideline that came out a year later was “a lot better” because it advised doctors not to begin long-term opioid therapy on any new patients.    

Instead of opioids, the DOD guideline recommends exercise, yoga and cognitive behavioral therapy to treat chronic pain, along with non-opioid drugs such as gabapentin.

Study Estimates Two Million Americans Use Kratom

By Pat Anson, PNN Editor

A new study estimates that less than one percent of Americans -- about two million people --- use kratom, an herbal supplement that’s growing in popularity as a treatment for pain, depression, anxiety and addiction.

The study, one of the first to look at kratom use in the general population, is based on data from the 2019 National Survey on Drug Use and Health – the first year the annual survey asked respondents about kratom.

Researchers at New York University’s Grossman School of Medicine looked at data from over 56,000 people who participated in the survey and estimated that 0.7 percent of adults and adolescents in the U.S. used kratom in the past year.

Kratom use was more likely by people who also use cannabis, stimulants and cocaine, and was particularly common among those who misuse prescription opioids. About 10 percent of people diagnosed with opioid use disorder reported kratom use.

“It was not surprising at all that such a large portion of people with opioid use disorder use kratom. What I didn’t expect was to find kratom use to be independently linked to cannabis use disorder,” said study author Joseph Palamar, PhD, an associate professor of population health at NYU Grossman School of Medicine.

“A lot of people who use substances to get high also use other substances to get high — alone or in combination. If anything, I hope that results of this paper demonstrate not only that a lot of people with opioid use disorder use kratom, but also a lot of people who use other drugs have been adding this substance to their drug repertoires for whatever reason.”

Men, white people, and those with depression and serious mental illness were also more likely to report using kratom. Teenagers and adults over 50 were less likely to use it.

The findings are similar to those in a 2016 PNN survey of over 6,000 kratom users. A little over half said they primarily used kratom for pain relief, while others used it as a treatment for anxiety (14%), opioid withdrawal (9%), depression (9%) and alcoholism (3%).  Over 90% said kratom was “very effective” in treating their medical condition.   

“A lot of people who use kratom rave about its ability to decrease opioid withdrawal, but kratom itself can be addicting so people need to be aware and be careful. Kratom might indeed be able to serve as a useful tool for people seeking to get off opioids, but I think more research is needed to determine exactly how it should be used and how to use it safely,” Palamar said in an email to PNN.

The study, published in the American Journal of Preventive Medicine, notes that over 150 overdose deaths linked to kratom have been reported. But most of those overdoses also involved other drugs such as illicit fentanyl, heroin and cocaine, or prescription drugs such as benzodiazepines and psychiatric medications.    

“Given the high number of poisonings involving kratom combined with other drugs, I hope that at least people who decide to use it try to avoid combining it with other substances,” Palamar said.

Kratom comes from the leaves of a tree that grows in southeast Asia, where kratom has been used for centuries as a natural stimulant and pain reliever. Kratom can be sold legally in most U.S. states, but vendors can run into trouble if they claim it can be used to treat medical conditions. The FDA says it has “serious concerns” about kratom because of its opioid-like properties.

A 2020 study funded by the National Institute on Drug Abuse concluded that kratom is an effective treatment for pain, helps users reduce their use of opioids, and has a low risk of adverse effects.

The American Kratom Association, an advocacy group for kratom consumers and vendors, claims that 10 to 16 million Americans use kratom. That estimate is based on exports to the U.S. reported by kratom growers in Indonesia.

Pain Patients Worried About CDC Expanding Opioid Guideline

By Pat Anson, PNN Editor

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

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

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

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

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

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

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

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

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

WHAT SHOULD BE DONE WITH CDC OPIOID GUIDELINE?

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

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

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

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

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

Little Support for Guideline Expansion

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

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

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

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

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

Strong Opposition to 90 MME Limit

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

— Intractable Pain Patient

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

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

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

Patients Say CDC Opioid Guideline Made Their Pain Worse

By Pat Anson, PNN Editor

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

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

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

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

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

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

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

WHAT'S HAPPENED TO YOUR OPIOID PRESCRIPTIONS SINCE 2016?

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

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

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

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

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

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

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

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

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

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

• 29% were abandoned or discharged by a doctor

• 27% had a doctor who stopped prescribing opioids

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

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

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

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

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

‘Please Give Me My Life Back’

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

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

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

• 9% have used illegal drugs for pain relief

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

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

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

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

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

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

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

Patients and Providers Want CDC Opioid Guideline Revoked

By Pat Anson, PNN Editor

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

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

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

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

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

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

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

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

Overdoses Rising

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

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

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

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

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

HAS THE CDC GUIDELINE REDUCED OPIOID ADDICTION AND OVERDOSES?

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

‘Throw the Whole Mess Out’

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

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

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

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

WHAT SHOULD BE DONE WITH CDC GUIDELINE?

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

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

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

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

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

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

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

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

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

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

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

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

Study Debunks Theory About Rx Opioids Leading to Heroin Use

By Pat Anson, PNN Editor

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

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

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

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

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

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

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

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

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

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

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

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

Few Patients on Long-Term Opioids Engage in Risky Behavior

By Pat Anson, PNN Editor

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

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

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

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

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

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

JAMA Network Open

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

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

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

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

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

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

No Relationship Between Rx Opioids and Injury Deaths

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

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

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

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

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

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

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.