ER Opioids ‘Extremely Unlikely’ to Lead to Addiction

By Pat Anson

Many patients in pain have horror stories to share about their experiences in hospital emergency rooms, where they’ve been treated as drug seekers and denied opioid medication.

“I had a broken arm and was given nothing for pain when leaving the emergency room,” one patient told us. “They now treat everyone like a drug seeking addict even if you have legitimate pain!”

“My last ER visit has caused me PTSD. It was awful they put me in a room and turned the light off and left me there for hours,” said another.

“The emergency rooms are horrible,” said a patient with a fractured rib. “I wasn’t even asking the ER for meds. I wanted an x-ray or something because I was in excruciating pain.”

Are fears about opioid addiction justified? A new study found that the risk of developing opioid use disorder after being treated with intravenous opioids in the ER is quite low – less than one-tenth of one percent (0.002%).

Out of 506 patients treated with IV opioids in two Bronx emergency rooms, only one met the criteria for long-term or persistent opioid use six months later.

“These data suggest that the use of IV opioids for acute pain among opioid-naive patients is extremely unlikely to result in persistent opioid use,” wrote lead author Eddie Irizarry, MD, an emergency medicine physician at Montefiore Medical Center.

“Opioid naïve” means the patients had never taken opioids before or only used the drugs infrequently.

The study, recently published in The Journal of Emergency Medicine, defines persistent use as filling six or more opioid prescriptions in the 6 months after an ER visit, or an average of one prescription per month.

The most frequently reported IV opioid administered in the ER was morphine (94%), followed by hydromorphone (4%) or a combination of both morphine and hydromorphone (2%). The researchers noted that most of the morphine doses were “relatively modest.”

After being treated in the ER, 63 of the patients (12%) received an opioid prescription on discharge.   

The researchers cautioned that opioids should be used “judiciously” and that many ER patients could be treated with non-opioid analgesics such as acetaminophen. But they could find no evidence that IV opioids should be routinely denied in the ER.

“We are not aware of compelling data to support denying parenteral opioids to opioid-naïve patients who are suffering from severe acute pain,” said Irizarry.   

The research mirrors the findings from a 2017 Mayo Clinic study, which found that the risk of long-term opioid use is lower for ER patients than it is for patients treated in other medical settings. In the Mayo study, 1.1% of opioid naive patients became long term users. That compares to 2% of patients who were prescribed opioids in non-emergency settings.

Survey Finds Patients and Doctors Unsatisfied with Treatments for Acute Pain

By Pat Anson

Nine out of ten (89%) patients who recently had short-term acute pain say it caused a major disruption in their lives, limiting their ability to sleep, exercise and enjoy leisure activity, according to a new survey. Many patients also expressed dissatisfaction with the pain medication they received and want to try a new one if their pain returns.

The survey was conducted by Vertex Pharmaceuticals, which is awaiting FDA approval of suzetrigine, its experimental non-opioid medication for acute pain. Vertex surveyed 1,001 adults and 547 doctors who were treated for or who treated acute pain. The company also commissioned a survey by the American Academy of Orthopaedic Surgeons (AAOS), which asked similar questions of 49 of its members who treated patients with moderate-to-severe pain from surgery.

The resulting report, “The State of Pain in America,” is obviously intended to drum up support for suzetrigine by showcasing dissatisfaction with current treatment options for acute pain. But the surveys also provide some interesting insights into what patients and doctors think about opioids and pain care in general.

“The Vertex and AAOS surveys underscore that treating acute pain in today’s health care landscape can be complex, as are the complexities that patients and health care providers have when personalizing pain management, highlighting the unmet need in this therapeutic area for more options,” Vertex said.

About 80 million adults receive treatment for acute pain in the U.S. each year, about half of whom receive an opioid, according to Vertex. Many also take acetaminophen or nonsteroidal anti-inflammatory drugs (NSAIDs) for pain relief.

Nearly a third of patients (31%) said they stopped taking analgesics before their acute pain resolved and 77% said they would be interested in trying a different medication – clear indications of dissatisfaction with their pain care.

Patients were also concerned with how acute pain impacted their lives:

• 70% Limited their ability to walk and exercise

• 69% Limited their sleep

• 65% Limited their hobby or leisure activity

• 65% Made them feel irritable or emotionally drained

• Missed an average of 19 work days annually

The surveys also found that both patients and doctors were worried about the risk of opioid addiction:

• 49% of patients concerned about opioid addiction

• 78% of doctors concerned about patients becoming addicted to opioids

• 88% of doctors believe patients prefer to manage pain without opioids

• 67% of patients said they would request a non-opioid medication in the future

• 52% of patients want a pain medication with fewer side effects

In addition, 83% of providers and 74% of AAOS surgeons said there was a high need for a new class of non-opioid pain medication.

Whether suzetrigine is a solution to these issues is an open question. Unlike opioids, which act on pain receptors in the brain, suzetrigine is designed to block pain in the peripheral nervous system. That means it won’t have the same “liking” effects of opioids or be addictive.

But in clinical studies, suzetrigine was not more effective than a low dose of Vicodin in treating acute pain in patients recovering from minimally invasive surgeries.

The risk of a surgery patient misusing opioids or becoming addicted is actually quite low – less than one percent. One study even found that patients who received no opioids during surgery were more likely to have post-operative pain and require opioids during recovery.

Vertex hopes suzetrigine will be approved by the FDA in January for post-operative acute pain.  The company is also studying the drug as a treatment for pain caused by diabetic peripheral neuropathy and for lumbosacral radiculopathy.  

Poppy Seeds Draw More Scrutiny for Addiction Risk

By David Hilzenrath, Healthbeat

It sounds like a joke: poppy seeds infused with opioids.

Indeed, it was a plotline on the sitcom Seinfeld. But for some it has been a tragedy. People have died after drinking tea brewed from unwashed poppy seeds.

And after eating lemon poppy seed bread or an everything bagel, mothers reportedly have been separated from newborns because the women failed drug tests.

Poppy seeds come from the plant that produces opium and from which painkillers such as morphine and codeine are derived. During harvesting and processing, the seeds can become coated with the opium fluid.

Members of the House and Senate have proposed legislation “to prohibit the distribution and sale of contaminated poppy seeds in order to prevent harm, addiction, and further deaths from morphine-contaminated poppy seeds.” The bill was one of several on the agenda for a Sept. 10 House hearing.

The day before the hearing, The Marshall Project and Reveal reported on a woman who ate a salad with poppy seed dressing before giving birth, tested positive at the hospital for opiates, was reported to child welfare, and saw her baby taken into protective custody. Almost two weeks passed before she was allowed to bring her baby home, the story said.

“It’s not an urban legend: Eating poppy seeds can cause diners to test positive for codeine on a urinalysis,” the Defense Department warned military personnel in 2023.

The U.S. Anti-Doping Agency long ago issued a similar warning to athletes.

The Center for Science in the Public Interest, a watchdog group, petitioned the FDA in 2021 to limit the opiate content of poppy seeds. In May, after more than three years with no response, it sued the agency to force action.

“So far the FDA has been negligent in protecting consumers,” said Steve Hacala, whose son died after consuming poppy seed tea and who has joined forces with CSPI. The lawsuit was put on hold in July, after the FDA said it would respond to the group’s petition by the end of February 2025.

The FDA did not answer questions for this article. The agency generally does not comment on litigation, spokesperson Courtney Rhodes said.

A 2021 study co-authored by CSPI personnel found more than 100 reports to poison control centers between 2000 and 2018 resulting from intentional abuse or misuse of poppy seeds, said CSPI scientist Eva Greenthal, one of the study’s authors.

Only rarely would baked goods or other food items containing washed poppy seeds trigger positive drug tests, doctors who have studied the issue said.

It’s “exquisitely doubtful” that the “relatively trivial” amount of morphine in an everything bagel or the like would cause anyone harm, said Irving Haber, a doctor who has written about poppy seeds, specializes in pain medicine, and signed the CSPI petition to the FDA.

Unwashed Seeds More Potent

On the other hand, tea made from large quantities of unwashed poppy seeds could lead to addiction and overdose, doctors said. The risks are heightened if the person drinking the brew is also consuming other opioids, such as prescription pain relievers.

Benjamin Lai, a physician who chairs a program on opioids at the Mayo Clinic in Rochester, Minnesota, said he has been treating a patient who developed long-term opioid addiction from consuming poppy seed tea. The patient, a man in his 30s, found it at a health food store and was under the impression it would help him relax and recover from gym workouts. After a few months, he tried to stop and experienced withdrawal symptoms, Lai said.

Another patient, an older woman, developed withdrawal symptoms under similar circumstances but responded well to treatment, Lai said.

Some websites tout poppy seed tea as offering health benefits. And some sellers “may use specific language such as ‘raw,’ ‘unprocessed,’ or ‘unwashed’ to signal that their products contain higher concentrations of opiates than properly processed seeds,” the CSPI lawsuit said.

Steve Hacala’s son, Stephen Hacala, a music teacher, had been experiencing anxiety and insomnia, for which poppy seed tea is promoted as a natural remedy, the lawsuit said. In 2016, at age 24, he ordered a bag of poppy seeds online, rinsed them with water, and consumed the rinse. He died of morphine poisoning.

The only source of morphine found in Stephen’s home, where he died, was commercially available poppy seeds, a medical examiner at the Arkansas State Crime Lab said in a letter to the father. The medical examiner wrote that poppy seeds “very likely” caused Stephen’s death.

Steve Hacala estimated that the quantity of poppy seeds found in a 1-liter plastic water bottle in his son’s home could have delivered more than 10 times a lethal dose.

Steve Hacala and his wife, Betty, have funded CSPI’s efforts to call attention to the issue. (The publisher of KFF Health News, David Rousseau, is on the CSPI board.)

The lawsuit also cited mothers who, like those in the investigation by The Marshall Project and Reveal, ran afoul of rules meant to protect newborns. For example, though Jamie Silakowski had not used opioids while pregnant, she was initially prevented from leaving the hospital with her baby, the suit said.

Silakowski recalled that, before going to the hospital, she had eaten lemon poppy seed bread at Tim Hortons, a fast-food chain, CSPI said in its petition. “No one in the hospital believed Ms. Silakowski or appeared to be aware that the test results could occur from poppy seeds.”

People from child protective services made unannounced visits to her home, interviewed her other children, and questioned teachers at their school, she said in an interview.

While on maternity leave, she had to undergo drug testing, Silakowski said. “Peeing in front of someone like I’m a criminal — it was just mortifying.”

Even family members were questioning her, and there was nothing she could do to dispel doubts, she said. “Relationships were torn apart,” she said.

The parent company of Tim Hortons, Restaurant Brands International, which also owns Burger King and Popeyes, did not respond to questions from KFF Health News.

In July, The Washington Post reported that Trader Joe’s Everything but the Bagel seasoning was banned and being confiscated in South Korea because it contains poppy seeds. Trader Joe’s did not respond to inquiries for this article. The seasoning is listed for sale on the company’s website.

The U.S. Drug Enforcement Agency says unwashed poppy seeds can kill when used alone or in combination with other drugs. While poppy seeds are exempt from drug control under the Controlled Substances Act, opium contaminants on the seeds are not, the agency says. The Justice Department has brought criminal prosecutions over the sale of unwashed poppy seeds.

Meanwhile, the legislation to control poppy seed contamination has not gained much traction.

The Senate bill, introduced by Sen. Tom Cotton (R-Ark.), has two co-sponsors.

The House bill, introduced by Rep. Steve Womack (R-Ark.), has none. Though it was on the agenda, it didn’t come up at the recent hearing.

Healthbeat is a nonprofit newsroom covering public health published by Civic News Company and KFF Health News, a national newsroom that produces in-depth journalism about health issues.  

A New Study of Opioid Addiction Only Muddies the Water Further

By Pat Anson

Over the years, hundreds of studies have been conducted to determine how common it is for a pain patient on long-term opioid therapy to become addicted. Estimates range from less than 1% to more than 80% of patients developing opioid use disorder (OUD), also known as problematic pharmaceutical opioid use (POU).

The wide variation in estimates is largely due to conflicting definitions, terminology, study design and biases. Is a patient misusing or abusing prescription opioids? Do they show signs of dependence or withdrawal? It literally depends which study you read.

New research that tries to settle the matter may have only muddied the water further.

A team of researchers at the University of Bristol conducted a meta-analysis of 148 clinical studies involving over 4.3 million patients in North America and the UK who were treated with opioids for chronic non-cancer pain. The 148 studies were all that was left from nearly 5,300 that were initially screened and rejected for various reasons — which should tell you a lot about the quality of studies that are out there.

“Clinicians and policy makers need a more accurate estimate of the prevalence of problematic opioid use in pain patients so that they can gauge the true extent of the problem, change prescribing guidance if necessary, and develop and implement effective interventions to manage the problem.  Knowing the size of the problem is a necessary step to managing it,” said lead author Kyla Thomas, PhD, Professor of Public Health Medicine at the University of Bristol.

Thomas and her colleagues included studies in their review that reported any sign of POU, such as abuse, tolerance, addiction, dependence, misuse, substance use disorder or “aberrant behavior.” The latter includes seemingly benign behavior like a patient being poorly dressed or unkempt in appearance, canceling or missing an appointment, asking for a specific drug, or even just complaining about their pain.

In some studies, “misuse” was defined so broadly that it included patients who stopped using opioids because their pain went away or they took a pill less often than recommended. A patient like that might be suspected of hoarding or even selling their unused medication.     

In other words, the researchers cast a pretty wide net on what constitutes OUD. And they hauled in a lot of fish.

Their findings, recently published in the journal Addiction, estimate that nearly one in ten pain patients (9.3%) are dependent on opioids and have OUD.

Nearly a third (29.6%) have “signs and symptoms” of dependence and OUD, and over one in five (22%) displayed aberrant behavior.

“Prescription painkiller misuse and addiction are widespread in chronic pain patients” is how the University of Bristol trumpeted the results in a press release, with the lone caveat that “these findings should be interpreted with caution.”

‘OUD Is Everywhere’

Critics of the study were quick to point out that equating dependence with opioid use disorder is misleading at best – the equivalent of a diabetic dependent on insulin being labeled with “insulin use disorder.”

“This is just one more paper, one of zillions, that seizes upon some outcome measures that have poor or no basis in science and that are not in any way indicative of addiction,” says Stephen Nadeau, MD, Professor of Neurology at the University of Florida College of Medicine. “As is so common, it favors the ridiculous notion that OUD is everywhere.”

Nadeau says any patient on daily opioids will experience symptoms of dependence or withdrawal if their medication is suddenly stopped. Neither is a clear sign of addiction or substance use problem, just as a patient asking for a higher dose is not necessarily a symptom of OUD.

“There is never any recognition of the ubiquitous phenomenon of pseudo-addiction: a patient in desperate pain asks for an increase in dosage. Instead of the request being interpreted at face value, the patient is branded with the diagnosis of OUD and booted from the clinic,” Nadeau told PNN.

Being “branded” or stigmatized is something that chronic pain patients like Brett Bradford are all too familiar with. He thinks the new addiction study will only result in more patients being taken off opioids.

“All physicians coming out of med school are being taught these hyper anti-opioid policies. This is only going to fuel things to get worse,” said Bradford. “This madness will not stop until opiates are totally off the market and nobody will be able to get any pain meds for any reason, short of being on their death bed. Maybe. If they are lucky.”

Genes May Explain Why Gabapentin Works for Some Pain Patients

By Pat Anson

Over the years, gabapentin (Neurontin) has been prescribed for dozens of health conditions, from epilepsy and fibromyalgia to depression and post-operative pain. It’s even been used to treat bipolar disorder. Gabapentin has been marketed for so many different conditions – at times illegally -- that a pharmaceutical company executive infamously referred to the drug as “snake oil.”

Even though it’s been approved for medical use for over 30 years, the UK’s National Health Service admits it’s still “not clear exactly how gabapentin works.”

A new study may finally help explain why gabapentin is an effective pain medication for some patients and an addictive drug with unwelcome side effects for many others.

It could be all in the genes.

Researchers at the University of Edinburgh took another look at a previous study of women with chronic pelvic pain to see why gabapentin worked no better than a placebo for most, but was a moderately effective pain reliever for about 40% of them.

Researchers took saliva samples from 71 women who participated in the study -- 29 who responded to gabapentin and 42 who had no improvement -- and found that the responders were more likely to have a variation of the gene Neuregulin 3 (NRG3). The gene is primarily expressed in the brain, spinal cord and central nervous system, and helps regulate pain sensation and transmission.

The findings, recently published in the journal iScience, may explain why gabapentin works for some women with chronic pelvic pain.

"A genetic factor that can predict how well gabapentin will work in patients offers the prospect of tailored treatment, and provides invaluable insights into understanding chronic pain. We hope eventually to use this genetic marker to optimize personalized treatment decisions and minimize adverse effects for women with chronic pelvic pain," wrote lead author Scott Mackenzie, MD, from the University of Edinburgh's Centre for Reproductive Health.

The study also has implications for other chronic pain conditions. Further research is needed to confirm the findings, but researchers say a genetic test for NRG3 could help limit the use of gabapentin to people who actually benefit from the drug.

"Isolating this single genetic marker is an important discovery that could ultimately help refine treatments for millions of women worldwide who suffer from chronic pelvic pain, as well as increasing our understanding of its role in other pain conditions. We believe this is an exciting opportunity for collaboration with a commercial partner who can help translate the research into a clinical setting," said Susan Bodie, PhD, Head of Business Development for the College of Medicine and Veterinary Medicine at the University of Edinburgh.

Gabapentin and other nerve drugs like pregabalin (Lyrica) have come under increased scrutiny in the UK because they are increasingly involved in overdose deaths.  

A recent analysis of drug tests suggests that gabapentin is also being misused in the U.S. Gabapentin was found in in over 13% of urine samples that tested positive for fentanyl -- about twice the number of drug tests in which prescription opioids were found.

Despite the risks of side effects and addiction, gabapentin is increasingly prescribed “off-label” for conditions it is not approved to treat, such as dental pain. A 2019 study found little evidence that gabapentin and pregabalin should be used for pain and said their effectiveness was often exaggerated by prescribing guidelines.

The CDC’s revised opioid guideline says gabapentin and pregabalin can have “small to moderate improvements” on pain, but with a moderate risk of side effects.

Drug Prohibition Is Making the Overdose Crisis Worse

By Drs. Kora DeBeck and Perry Kendall

Should heroin and cocaine be legally available to people who need and want them? If we are serious about stopping the crisis of drug overdose deaths, that is exactly the kind of profound change we need. Yes, extensive regulations would be necessary. In fact, the whole point of regulating drug production and sales is that we can better control what is being sold and to whom.

After British Columbia’s Provincial Health Officer Dr. Bonnie Henry testified to the all-party health committee in Ottawa in May that regulating these controlled drugs would minimize harms, B.C. Premier David Eby said he disagreed. He is quoted saying “in a reality-based, real-world level, (it) doesn’t make any sense.” But does our current approach of drug prohibition “make sense?”

Since the overdose crisis was declared in 2016, illicit drug toxicity deaths have become the leading cause of unnatural death in B.C. and the leading cause of death from all causes for those aged 10 to 59. More than 44,000 people have died from drug poisoning in Canada since 2016, and more than one-third of those were in B.C. An average of 22 people are dying every day in Canada because the illicit supply of drugs is toxic.

Toxic Drug Supply

Why is the drug supply so toxic? Because we are letting organized crime manufacture drugs instead of regulated licensed industries that are required to follow health and safety standards.

In the context of drug prohibition, organized crime and drug cartels are incentivized to make highly potent products because it is cheaper and hence more profitable. This is what happened during alcohol prohibition in the 1920s. Organized crime ran rampant, and people were poisoned because there were no health and safety standards for production.

The failure of alcohol prohibition in meeting its key objectives of eliminating the supply and demand of alcohol are the same failures of drug prohibition. Illegal drugs are easy to find regardless of their illegal status. Reliable estimates are that 225,000 people are using illegal substances in B.C.

What is the way out? Our knowledge of research evidence and decades of collective experience — including as a researcher (Kora DeBeck), a B.C. provincial health officer (Perry Kendall) and chief coroner (Lisa Lapointe) during the overdose crisis — brings us to drug regulation. When we regulate a substance, we have the most control over its production, distribution and consumption.

Lessons From Tobacco

Some may argue that regulating drugs sends the “wrong message” and will encourage drug use, most concerningly among young people. However, if we look to lessons from tobacco regulation, we can see that public health-based regulations can actually be strong and effective substance-use deterrents.

By strictly controlling tobacco marketing, packaging, purchase price, purchase age and consumption locations alongside educating people about the health risks, tobacco consumption and associated health harms have been significantly reduced without all the additional risks of banning tobacco products (for example, criminal black markets controlling production and sales).

The same kinds of regulatory tools would be available to control the use of currently illegal drugs if we moved from prohibition to regulation.

Addiction Treatment Not Enough

But what about addiction treatment? Isn’t that what we really need? While it’s true that eliminating wait times and increasing access to effective, evidence-based treatment are critically important and much needed, the reality is that many people who use drugs don’t have an addiction and many others are not currently seeking treatment. Yet all people who use drugs face the deadly consequences of an unregulated toxic drug supply.

It is also important to remember that addiction recovery is complex and relapse is common in the recovery journey. In today’s toxic drug environment, people who relapse after a period of abstinence face a significantly higher risk of death due to their reduced tolerance. We also know that substance treatment is not regulated or standardized, and treatment outcomes are not reported.

While supporting people to recovery is important and can be lifesaving, addiction treatment is not the straightforward solution many believe it should be. Thousands of lives remain at risk every day.

A Regulated Drug Supply

Taking the production and sale of currently illegal drugs away from organized crime and drug cartels is the most promising way to keep our kids and communities safe. With strict health and safety standards for the production of these drugs and stringent public health-based regulations on their distribution and sale, we have the best shot at reversing the carnage of overdose fatalities and managing drug-related harms.

Regulating drugs may seem to some like a radical proposition but governments regulate the production and distribution of potentially dangerous goods all the time. The regulation of firearms in Canada includes licensing that requires passing a firearms safety course. Mandatory ingredient lists that disclose the amount of sugar, sodium and fat in the foods we eat is another example of a government regulation that is designed to protect the public and provide information that may shape consumption patterns and reduce health risks.

Implementing an effective regulatory framework for currently illegal drugs will be a complex undertaking requiring close monitoring and evaluation and inevitably corrections and revisions along the way. While the task may appear daunting, allowing overdose deaths to continue at the current rate is unconscionable.

Transformational and life-saving drug regulation is urgently required because, borrowing terminology from Premier Eby, at the “reality-based, real-world level,” our current approach is a catastrophic failure.

Kora DeBeck, PhD, is a Distinguished Associate Professor in the School of Public Policy at Simon Fraser University and a Research Scientist at the BC Centre on Substance Use.

Perry Kendall is a Clinical Professor in the Faculty of Medicine, School of Population and Public Health at the University of British Columbia. He is also a former Provincial Health Officer for BC

This article was also co-authored by Lisa Lapointe, who was BC’s Chief Coroner from 2011 to 2024.

This article originally appeared in The Conversation and is republished with permission.

Naltrexone Shortage Disrupts Addiction Treatment

By Pat Anson, PNN Editor

An inexpensive drug used to manage chronic pain and treat substance use disorders has joined the growing list of medications that are in short supply in the United States.

The Food and Drug Administration and the American Society of Health-System Pharmacists (ASHP) both recently added naltrexone tablets to their drug shortage lists. It’s not clear what caused the shortage, but the ASHP says “there is insufficient supply for usual ordering.”  

Naltrexone is FDA-approved to treat both alcohol and opioid use disorder, and is also used off-label in low doses to treat some chronic pain conditions.

In 50mg doses, naltrexone blocks opioid receptors in the brain and reduces cravings for opiates or alcohol. But in smaller doses of 5mg or less, patients have found low-dose naltrexone (LDN) to be an effective pain reliever for interstitial cystitis, Ehlers-Danlos syndrome, fibromyalgia, and other painful conditions.

LDN advocates believe the drug modulates the immune system, reduces inflammation and stimulates the production of endorphins, the body's natural painkiller. Because it is an opioid antagonist, naltrexone should not be taken with opioid medication.

So far, the shortage only affects 50mg naltrexone tablets. Pain patients usually obtain LDN by prescription from compounding pharmacies, which make the low dose versions in-house.

Several drug makers are reporting short supplies of 50mg tablets, including Accord Healthcare, Major, Elite Laboratories, SpecGx, Sun Pharma, Tagi Pharma, and Avet Pharmaceuticals. The companies didn’t provide the ASHP with a reason for the shortage, but said the tablets are on back order and would be released when they become available.    

The naltrexone shortage comes at an inopportune time, as more people abused alcohol and other substances during the pandemic and sought treatment. The drug that helps them stay sober is now hard to get.

"People are coming in with more cravings," Dr. Aviva Zohar, an addiction medicine provider, told Philly Voice. "Even the feeling of, 'I don't know when my medicine is coming in,' is a huge struggle. It's horrific (and) causing a lot of stress.”

To make up for the shortage, some providers are giving patients Vivitrol, an injectable, extended-release formulation of naltrexone taken once a month. A single Vivitrol injection costs about $1,700, while a month’s supply of 50mg naltrexone tablets costs about $48.

The cheap price of naltrexone may be responsible for the shortage. Most drugs in short supply are low-cost generics with slim profit margins. Some manufacturers have reduced or stopped making generics because they’re not worth the cost of production or the risk of litigation.   

Three generic opioids commonly taken for pain — immediate-release oxycodone, oxycodone-acetaminophen, and hydrocodone-acetaminophen tablets — have been on the ASHP shortage list for nearly a year, with no end in sight.

Prescription Opioids Play Only Minor Role in Overdose Crisis

By Pat Anson, PNN Editor

The role of prescription opioids in the nation’s overdose crisis continues to shrink.

In a new study from the drug testing firm Millennium Health, researchers say multiple substances were found last year in nearly 93% of urine samples in which fentanyl was detected. That is not altogether surprising, as “polysubstance” use increased as fentanyl came to dominate the illicit drug supply, appearing in more and more street drugs such as heroin, cocaine and methamphetamine.

What is surprising is the minimal role that prescription opioids now play. In 2013, opioid pain medication was the most common substance found in fentanyl-positive drug tests in the United States, appearing in over 70% of urine samples.  A decade later, prescription opioids were detected in less than one in ten samples — ranking far behind methamphetamine, cannabis, cocaine and heroin.

In fact, you are about twice as likely to find two other medications -- benzodiazepines (15.8%) and gabapentin (13.3%) -- than you are prescription opioids (7.6%) in urine samples testing positive for fentanyl.

Substances Detected in Fentanyl-Positive Drug Tests (2023)

MILLEnNIUM HEALTH

Millennium based its findings on over 4.1 million urine drug tests (UDTs) collected from 2013 to 2023 and analyzed through mass spectrometry. Because many of those samples came from people being treated for a substance use disorder, they offer a clear insight into drug trends that are driving the overdose crisis.

Now in its “fourth wave,” Millennium says a tidal shift has occurred in the so-called opioid epidemic, with illicit drug users far more likely to use non-opioid substances like stimulants than prescription opioids.

“National, regional, and state-level UDT data all suggest that people who use fentanyl are now, intentionally or unintentionally, much more likely to also use methamphetamine and cocaine,” the report found. “The results of our analyses also reveal shifting patterns of opioid use among those who use fentanyl. More specifically, they showed progressive declines in prescription opioid use from 2015 to 2023.”

The declining role of prescription opioids can be traced back to the 2016 CDC opioid guideline and a multiyear campaign by the DEA to slash opioid production quotas, which has reduced the supply of oxycodone and hydrocodone by about two-thirds. There is little evidence either of those federal efforts reduced the number of overdoses. The CDC estimates there were over 111,000 drug deaths in the 12-month period ending in September 2023 — nearly double the number of fatal overdoses in 2016.

The growing use of stimulants such as methamphetamine makes it difficult for public health campaigns to address the problem. Unlike opioids, there are no FDA-approved medications for stimulant use disorder, leaving behavioral therapies and abstinence as the only “evidence-based” treatments for people with a stimulant problem.

“Stimulants are a serious national challenge emphasizing the need for continued progress on the national plan to address methamphetamine supply, use, and consequences,” Millennium said.

‘Safe Supply’ of Rx Opioids Saved Lives in British Columbia

By Pat Anson, PNN Editor

Prescribing opioids and other medications to people with substance use disorders significantly reduces their risk of dying, according to a large new study in British Columbia. The findings add weight to efforts to create a “safe supply” of legal medications for patients at risk of an overdose from increasingly toxic street drugs.

Vancouver, British Columbia was the first major North American city to be hit by a wave of overdoses involving illicit fentanyl, a potent synthetic opioid. That led Vancouver to become a laboratory for harm reduction programs and safe supply sites offering prescription opioids and injectable heroin to drug users.  

How effective have those programs been?

A study by the B.C. Centre for Disease Control, recently published in the British Medical Journal, found that prescribing opioids, stimulants and anti-anxiety medication to nearly 6,000 drug users dramatically reduced their risk of death.

The Risk Mitigation Guide (RMG) program was initially launched in early 2020 to help drug users going through withdrawal while isolated by the COVID-19 quarantine. A year later, the program was extended, allowing doctors and nurse practitioners to prescribe hydromorphone, morphine, oxycodone, fentanyl, benzodiazepines and stimulants to drug users.

People who were given an initial dose of prescription opioids had a 61% lower risk of death from any cause the following week, and were 55% less likely to die of a drug overdose.

The protective effect of a safe supply increased as more doses were provided. Drug users who received four or more days of opioids were 91% less likely to die from any cause and 89% less likely to die from an overdose.

"We saw a profound impact on reduction in somebody's overdose death risk the week after they picked up these drugs, to a degree that is really surprising and has enormous potential," co-author Paxton Bach, MD, an addiction medicine specialist, told CBC News. "This paper is the strongest evidence we have so far, by a large margin, supporting the idea that this can be an effective strategy for reducing overdose death risk."

But critics of safe supply programs say they don’t really reduce drug abuse. An investigation last year by the National Post found that hydromorphone pills given to drug users in Vancouver were being sold to other addicts, with the sellers then using the money to buy more potent street drugs that were often laced with fentanyl.

A new study in JAMA Internal Medicine also found that opioid-related hospitalizations rose sharply in British Columbia after safe supply programs were launched there, although there was no significant change in overdose deaths. The spike in hospitalizations may have been due to more potent street drugs and counterfeit pills on the black market.

Since a public health emergency was declared in British Columbia in 2016, over 13,000 people have died from drug overdoses. A 2020 analysis found that only about 2% of the B.C. opioid-related deaths were caused by prescription opioids alone. The other overdoses mainly involved illicit fentanyl and other street drugs.  

FDA Approves Genetic Test for Opioid Addiction Risk

By Pat Anson, PNN Editor

The U.S. Food and Drug Administration has approved a controversial genetic test that uses a patient’s DNA to assess whether they are at risk of developing opioid use disorder (OUD).  

Although the test is only intended for patients with short-term acute pain who have not used opioids before, there is concern about the test’s accuracy and whether it will be used “off-label” to assess addiction risk in chronic pain patients – who could potentially lose access to opioids as a result.

In approving the AvertD test, the FDA stipulated that it only be available by prescription to patients who consent to its use and have no prior history of using an oral opioid for pain relief.

The test is administered by a provider swabbing the cheek of a patient to collect a DNA sample, which will then be tested in a laboratory to see if the patient has 15 genetic markers that puts them at elevated risk of OUD.

According to the FDA, the test will help patients “make better informed decisions” about opioids, such as a patient facing surgery who wants to know what analgesic to use for acute post-operative pain.

AUTOGENOMICS IMAGE

"AvertD may help patients who are concerned about being treated with an opioid for acute pain,” Jeff Shuren, MD, director of the FDA's Center for Devices and Radiological Health, said in a statement. “The test is not intended to be used in patients being treated for chronic pain.”

But given the history of opioid guidelines being mistakenly applied to all kinds of patients, regardless of their condition, some worry the test will be misused.

“I’m sure it would be used for anyone who may be considered for opioid therapy,” says Lynn Webster, MD, a pain management expert and Senior Fellow at the Center for U.S. Policy. “I am all for gathering more data to help clinicians make better decisions, but we must exercise caution with such tests. Otherwise, the test may be over-read or misinterpreted. Some patients may be deprived of access to an opioid if they test positive or there can be a false sense of harmlessness from opioids if the test is negative. 

“I am most concerned that providers will see the results as binary. Either a patient will or won’t develop OUD, depending on the result. That would be a big mistake. Any such device or test must be used along with other clinical and personal information to help mitigate harm from using, or being denied, opioids.”

80% Accuracy

As part of its approval order, the FDA is requiring AutoGenomics – the company that makes AvertD – to provide training to healthcare providers on the proper use of the test and to conduct a post-market study of its performance and accuracy.

In 2022, an FDA advisory committee voted 11-2 against recommending an earlier version of AvertD, primarily because of concerns about false-negative and false-positive results. An observational study found the test was about 80% accurate in detecting genes associated with OUD.

"I believe 100% of the risk associated with this test is with false positives and false negatives -- both people being untreated or poorly treated because somehow it came back as a positive result, or being given inappropriate treatment because it said negative," said Timothy Ness, MD, an anesthesiologist and Professor Emeritus at the University of Alabama at Birmingham, an advisory panel member who voted no.

After the advisory committee vote, the FDA worked with AutoGenomics to modify the test and improve its accuracy. The company then submitted a premarket approval application for the modified test, which the FDA granted without going back to the advisory committee for further review.

“The FDA recognizes that in premarket decision-making for devices, there generally exists some uncertainty around benefits and risks. Given the totality of available evidence and the urgent need for medical devices that can make a positive impact on the overdose crisis, and specifically devices that can help assess the risk of developing OUD, the FDA determined that there is a reasonable assurance of AvertD's safety and effectiveness,” said Dr. Shuren.

But no test is foolproof in either its accuracy or implementation, as Dr. Webster learned when he developed a questionnaire that assesses addiction risk by asking patients about their family history and other potential risk factors. Webster was disappointed to learn his questionnaire was “weaponized” by some providers to deny opioid therapy to patients, particularly women with a history being sexually abused.

Webster says the risk of OUD can’t be measured by a genetic test alone.

“We should not think it is a diagnostic tool or a crystal ball. Having an increased risk due to genetics does not mean that, if exposed to an opioid, an individual necessarily will develop an opioid addiction,” Webster told PNN. 

“We have known for a long time that about fifty percent of the risk of developing an opioid addiction is due to genetics. The other fifty percent is due to environmental factors and life’s experience. Furthermore, people can develop OUD without genetic risks. OUD risk is dynamic, meaning it changes over time with adverse events in life and often co-morbid conditions. For example, there was a surge in all forms of drug abuse, including OUD, during the pandemic because of isolation and loneliness. This is not detected by a genetic test.”

Although the risk of a surgery patient misusing opioids or becoming addicted is low – less than one percent -- the parent company of AutoGenomics has a more stark assessment, calling surgery “a gateway to addiction” that puts another 7 million Americans at risk every year.

We Must Overcome Stigma Against Buprenorphine for Pain

By Dr. Stefan Franzen

For years I had a negative impression of buprenorphine as a pain medication, both from personal descriptions I had heard by pain patients and from the scientific and medical literature.

I have since learned that buprenorphine can be effective pain reliever. At a high dose, the efficacy is similar to that of high-dose morphine or oxycodone, which were once commonly used to treat chronic or intractable pain.

Today, high doses of any opioid are shunned by most doctors because they are subject to increased scrutiny by state medical boards or even investigation by the Drug Enforcement Administration. The medical and moral justification of alleviating patient suffering appears to be irrelevant to public health authorities, even when they profess to favor a humane policy to treat pain.  

We need a more rational discussion about opioids. Buprenorphine is an opioid that, when used alone, can play a role in pain treatment. Buprenorphine was developed in the United Kingdom in the 1960s and has been used in many countries to treat pain since the 1980s.

We must distinguish pure buprenorphine from Suboxone, which is a combination of buprenorphine and naloxone. Suboxone is given to people with opioid use disorder to help prevent abuse. If a tablet is crushed, extracted or injected by a drug abuser, the naloxone will block the effects of buprenorphine. However, if taken as directed under the tongue, the naloxone has much lower bioavailability.

A pain patient does not necessarily need naloxone and, depending on individual differences in body chemistry, the naloxone may even have negative effects. There is no reason to prescribe Suboxone for pain. It’s use as a pain medication is highly inappropriate, but may be the result of doctor’s fear of DEA action.

Pure buprenorphine is a different matter.

The CDC’s 2016 opioid guideline recommended that daily opioid doses not exceed 90 morphine milligram equivalents (MME).  Although voluntary, the guideline was seized upon by other federal agencies and state legislatures to justify draconian new laws and regulations that limited opioid doses to 90 MME or less.

No such limits have been set for buprenorphine. However, few doctors in the U.S. prescribe buprenorphine for pain, despite recent studies demonstrating its efficacy and international recognition that it is an effective analgesic.

For historical reasons, American doctors do not know much about buprenorphine as a pain medication. Moreover, many fear prescribing any opioid in today’s regulatory climate. Patients know that buprenorphine has been used to treat addiction and therefore are suspicious of it as a pain treatment. They are also justifiably concerned about being stigmatized as a drug abuser if they are prescribed Suboxone.

U.S. Opioid Policy Lacks Common Sense

In short, the stigma surrounding buprenorphine is a significant factor preventing development of a rational opioid policy in the U.S.

Many patients with experience taking morphine, oxycodone, hydrocodone and other opioids say they are safe and non-addictive. Research shows that is true for a great many pain patients. However, a small fraction of the population is susceptible to opioid abuse and addiction. This is a classic ethics problem.

Should we let 99% of patients suffer because 1% might harm themselves? How do other societies manage this problem? We know what doesn’t work. The “War on Drugs” has been an unmitigated disaster for everyone: drug abusers, doctors, pain patients and their loved ones. Our drug overdose rate is 15 times higher than that the of European Union.

Worse still, our medical system and corporate regulation appear to lack common sense guardrails needed to prevent the diversion of prescription opioids -- even after massive publicity, sensational books, documentaries, and popular miniseries on the opioid crisis.

In case anyone had any doubt, the book “American Cartel” shows that diversion was mainly practiced by large opioid distributors and a few manufacturers, who flooded vulnerable communities with prescription opioids. Theft and deception of doctors by drug abusers also contributed to diversion. Each of these could be controlled in a sensible way, without forbidding people in pain from receiving medication. Yet, at present it appears there is no political will in the U.S. to even treat pain, regardless of the suffering of millions.

Instead, the politicians and media blame opioid prescribing, which implicitly blames doctors and patients. Perhaps as a response to this seemingly hopeless situation, a growing number of medical researchers have begun testing pure buprenorphine for the treatment of pain.

After seeing the effectiveness of buprenorphine, which I discuss in my new book, “Z’s Odyssey,” I became convinced that it is a viable treatment for even severe, intractable pain. This should be a choice, but the problem today is that many patients do not have a choice.

Pure buprenorphine for pain was not available in the United States until 2010, when the low-dose Butrans skin patch became available.

In 2015, a buccal formulation designed for absorption through the cheek became available. Belbuca film is quite convenient and comes in a moderate dose.

For intractable pain, a sublingual formulation of buprenorphine known as Subutex can be prescribed off label for pain. Subutex is also used to treat opioid addiction, but does not contain naloxone.

A Subutex tablet placed under the tongue takes about 20 minutes to be completely absorbed. Because buprenorphine binds to the pain receptors more tightly than any other opioid, the dose in milligrams required for full effect is much lower than similar strength morphine. Many medical researchers have concluded that buprenorphine is an excellent analgesic, with low risk for addiction or overdose. If taken as directed, the risk of respiratory depression from buprenorphine is the lowest of any opioid.

For pain relief, U.S. doctors must prescribe Subutex off-label, which means that they are prescribing for a condition that is not FDA approved.  Subutex is approved for pain in Great Britain and most of Europe. The UK’s National Health Service recommends Subutex and other formulations of buprenorphine for patients “when weaker opioids for pain stop working.”

Of course, buprenorphine is not beneficial for every patient. And there is an issue of dental decay that requires careful monitoring and appropriate procedures. But for people in the most severe pain, who lack any other option because of the opioid prohibition mindset, buprenorphine may offer relief.

Finding a doctor willing to prescribe Subutex off label could be difficult. For severe or intractable pain that requires a high dose, a patient most likely needs to find a psychiatric or addiction treatment doctor licensed to prescribe buprenorphine in formulations such as Subutex that are pure buprenorphine.

Since 2000, the U.S. Congress has passed three laws that make buprenorphine more accessible to people with opioid use disorder.  If Congress can aggressively lower the barriers to prescribing high-dose buprenorphine for addiction treatment, then why shouldn’t pain patients have access to medication that has the same dose of the active agent?

There is an education gap that prevents doctors and society at large from effectively managing this situation. The medical literature is heavily weighted toward studies of buprenorphine for addiction, with almost 97% of studies on opioid use disorder and less than 3% on pain.  Pain patients also fear the stigma associated with buprenorphine as an addiction treatment, rather than an analgesic.

There is no objective reason for this. At the very least, buprenorphine should be an option for those forgotten patients who still live in pain. By overcoming the stigma of buprenorphine, doctors could treat patients with dignity by prescribing a safer and more effective medication. 

Stefan Franzen, PhD, is a Professor of Chemistry at North Carolina State University. Franzen is the author of “Patient Z” – a book that looks at pain, addiction and the opioid crisis through the eyes of a patient who can’t find good pain care. He recently published a sequel to Z’s story, called “Z’s Odyssey.”

Stimulants Involved in Growing Number of Fentanyl Overdoses

By Pat Anson, PNN Editor

The number of drug deaths involving both fentanyl and stimulants has soared in recent years, according to a new UCLA study that highlights the complex and changing nature of the U.S. overdose crisis.

Stimulants such as cocaine and methamphetamine are now involved in nearly a third of fentanyl-related overdoses, the most of any other drug class. Fentanyl is a synthetic opioid up to 100 times more potent than morphine and 50 times as potent as heroin.

In 2010, researchers say there were only 235 fatal overdoses in the U.S. involving illicit fentanyl and stimulants. In 2021, there were 34,429 drug deaths linked to fentanyl and stimulants, a 14,550% increase in a little over a decade.

"We're now seeing that the use of fentanyl together with stimulants is rapidly becoming the dominant force in the US overdose crisis," said lead author Joseph Friedman, PhD, an addiction researcher at the David Geffen School of Medicine at UCLA. "Fentanyl has ushered in a polysubstance overdose crisis, meaning that people are mixing fentanyl with other drugs, like stimulants, but also countless other synthetic substances. This poses many health risks and new challenges for health care providers.

“We have data and medical expertise about treating opioid use disorders, but comparatively little experience with the combination of opioids and stimulants together, or opioids mixed with other drugs. This makes it hard to stabilize people medically who are withdrawing from polysubstance use."

People who overdose on stimulants and other non-opioid substances mixed with fentanyl may not be as responsive to naloxone, which only works as an antidote to opioids.

The study findings, published in the journal Addiction, highlight the four “waves” of the overdose crisis, which began with an increase in deaths from prescription opioids (Wave 1) in the early 2000s, followed by a rise in heroin deaths (Wave 2) in 2010, and fentanyl-related overdoses in 2013 (Wave 3). The fourth wave — overdoses from fentanyl and stimulants — began in 2015 and continues to escalate.

The Four Waves of Overdose Crisis

SOURCE: ADDICTION

Since cocaine, methamphetamine and other stimulants are not opioids, the findings undercut the long-held theory that the overdose crisis started with prescription opioids and is still being fueled by people addicted to them. Deaths involving prescription opioids and heroin have been in decline for several years.

Researchers found that fentanyl/stimulant deaths disproportionately affect African Americans and Native Americans. There are also geographical patterns to fentanyl/stimulant use. In the northeast US, fentanyl is usually combined with cocaine, while in the south and western US, fentanyl is most commonly found with methamphetamine.

"We suspect this pattern reflects the rising availability of, and preference for, low-cost, high-purity methamphetamine throughout the US, and the fact that the Northeast has a well-entrenched pattern of illicit cocaine use that has so far resisted the complete takeover by methamphetamine seen elsewhere in the country," Friedman said.

In addition to its low cost, drug users say methamphetamine helps prolong fentanyl’s “high” and delays the onset of withdrawal symptoms.  

Counterfeit pills laced with fentanyl – which are frequently made to look like oxycodone or alprazolam (Xanax) – represent about a quarter of all illicit fentanyl seizures. Researchers say it is difficult to track deaths involving counterfeit pills because they are often mistaken for legitimate medication, so the data is not completely reliable.

In its most recent update on the overdose crisis, the CDC estimates there were a record 111,355 drug deaths in the 12-month period ending April 2023 -- about a thousand more deaths than the year before. Fentanyl and its analogues were involved in nearly 70% of the overdoses, stimulants were linked to about a third of them, and cocaine was involved in about a quarter of the drug deaths.

America’s Biggest Fear: Fentanyl and Opioid Addiction

By Pat Anson, PNN Editor

The fentanyl crisis is the biggest public health problem in the US, according to two new surveys that highlight Americans’ growing fears about opioid addiction and the toxicity of street drugs.

The first survey, conducted by Axios-Ipsos, found that opioids and fentanyl have surpassed Covid-19, firearms, obesity and cancer as the nation’s #1 public health threat. Over one in four Americans (26%) ranked opioids and fentanyl first, replacing gun violence as the top threat to public health.  

Top U.S. Public Health Threats

Fentanyl is a synthetic opioid that is 100 times more potent than morphine. It has been used safely for decades as an analgesic during surgery and to treat severe pain, but in recent years illicit versions of fentanyl have come to dominate the black market, where they are used in counterfeit medication or mixed with substances like heroin. Most fatal overdoses in the U.S. involve illicit fentanyl, not prescription opioids.

The Axios-Ipsos survey found that about four in ten adults (44%) are aware that U.S. overdose deaths reached a record high last year. Americans who live in rural areas, which have some of the highest overdose rates, are even more familiar (51%) with the rising number of drug deaths. 

Over half the respondents (51%) said they cared a lot about overdoses and think the government should be doing more to reduce drug deaths (79%). Most also believe that government does not make the health and well-being of citizens a priority (62%).  

While most Americans trust the health information they get from federal agencies like the CDC (64%) and FDA (62%), there is more trust placed in health information from personal doctors (89%) and family members/close friends (75%). 

Other key findings about respondents’ drug use in the last three months:

• 26% used a pain medication for which they had a prescription or knew someone who did

• 3% used a pain medication for which they did not have a prescription or knew someone who did

• 20% used cannabis or knew someone who did

• 2% used hallucinogenic drugs or new someone who did

• 2% used “other illegal drugs” or knew someone who did

“Pain medication” was not defined in the survey questions, so the responses may include some non-opioid analgesics.

The recently updated Axios-Ipsos American Health Index is based on a nationally representative sample of 1,162 adults, who were surveyed on a wide array of health topics from August 11-14.

Most Families Impacted by Addiction

The second survey, conducted by the non-profit KFF, asked a representative sample of 1,327 adults online and over the phone in July about a variety of drug and substance use issues.

Two-thirds of respondents said either they or a family member were addicted to alcohol or drugs, experienced homelessness due to addiction, or had a drug overdose resulting in hospitalization or death.  

Nearly three in ten (29%) said they or someone in their family were addicted to opioids, either prescription opioids or illicit ones like fentanyl and heroin. Opioid addiction was most common among rural residents (42%) and White adults (33%). Among those who experienced addiction firsthand, most said it had a negative impact on their family’s relationships and finances. 

Only 5% felt they themselves might be addicted to opioid painkillers, far less than those who believe they might be addicted to alcohol (13%). 

Fear about addiction is common. Over half (51%) of adults are worried that someone in their family will experience a substance use disorder and one-third (32%) are worried that someone in their family will overdose on opioids.  

About four in ten adults (39%) are worried that someone in their family will unintentionally consume illicit fentanyl, a fear that looms largest in rural areas (48%). 

SOURCE: KFF

Nearly three in ten respondents (29%) said they had been prescribed opioid pain medication in the past five years. Of those, most said their doctors had warned them about the risks of opioid addiction and dependence (57%), side effects from opioids (69%), other ways to manage pain (60%), and about keeping their medications in a safe place (58%).  

While fears about addiction to opioid pain medication are common, it doesn’t happen nearly as often as many people believe. A recent study in Australia found that 92% of patients prescribed opioids for the first time never progressed to long-term use. Less than 3% became persistent users or needed higher doses — and they were mostly seniors with chronic health problems.

Neither the KFF or Axios-Ipsos polls asked respondents about growing shortages of opioid pain medication or how the reduced supply was impacting legitimate pain patients.   

‘Unintended Victims’

The patient side of the story was shared this week in an opinion video by The New York Times. Video producers Vishakha Darbha, Lucy King and Adam Westbrook spoke with chronic pain patients who are the “unintended victims” of the national crackdown on opioid prescribing.

“America’s doctors have been put in a difficult position. But it doesn’t need to be this way. It is possible to stop overprescribing yet ensure that pain sufferers get the relief they deserve. The patients in our video have one message: Listen to us,” the producers said.

Large Study Debunks Myths About Rx Opioid Addiction

By Pat Anson, PNN Editor

A large new study in Australia is debunking myths about the addictive nature of opioid pain medication and how a single prescription can lead to long term use.

In an analysis of nearly 3.5 million Australians who were prescribed opioids for the first time, researchers found that 92% never progressed beyond low opioid use and only 3% became persistent users or needed higher doses. The “sustained use” of opioids occurred mostly in seniors (65 and older) suffering from cancer, depression, anxiety and other chronic health problems.

“Results of this cohort study suggest that most individuals commencing treatment with prescription opioids had relatively low and time-limited exposure to opioids over a 5-year period,” wrote lead author Natasa Gisev, PhD, a clinical pharmacist at National Drug and Alcohol Research Centre, UNSW Sydney.

“The small proportion of individuals with sustained or increasing use was older with more comorbidities and use of psychotropic and other analgesic drugs, likely reflecting a higher prevalence of pain and treatment needs in these individuals.”

Previous research estimated the risk of long-term opioid use as high as 57 percent, but Gisev and her colleagues say those studies are flawed because they excluded people with cancer and opioid use disorder, or used various definitions of long-term use. The Australian researchers took a different approach in tracking opioid prescriptions, developing five “trajectories of opioid use.”

The vast majority of patients had very low (75%) or low use (17%) of opioids. Others started with moderate opioid use and decreased to low use (3%), or began with low use and increased to moderate use (3%). Only 3% became sustained users or took higher doses.

Five-Year Trajectories of Opioid Use

JAMA NETWORK OPEN

“Overall, these findings suggest that most people who initiate an opioid prescription are likely to have low, time-limited exposure to opioids with little indication of ongoing use. This possibility is an important consideration for policymakers and stakeholders considering population-level prescribing of high-risk drugs,” researchers reported in JAMA Network Open.

“Opioids are essential drugs for acute and cancer pain, and many people with CNCP (chronic non-cancer pain) benefit from opioids. Continued focus and policy responses based on findings from a small group of people with increased risk of harms run the risk of limiting access to people who safely derive objective benefits from opioids.”  

That’s exactly what happened to millions of pain patients in the US, who lost access to opioids due to steep cuts in prescribing, chronic shortages of opioid medication, and a relentless drumbeat in the media about people becoming addicted or overdosing after one pill.  

“One prescription can be all it takes to lose everything,” the CDC said in a 2017 advertising campaign that emphasized the risks of prescription opioids, while ignoring the far more serious problem of illicit fentanyl and other street drugs.

Just how common is opioid addiction? Estimates are all over the map, ranging as low as 1% to as high as 40% for long-term opioid users.

“The problem with all of these studies is that they are retrospective in nature, limited to a particular patient population, and constrained by the diagnostic criteria in use at the time,” my late colleague Roger Chriss pointed out in a 2019 column on opioid addiction.  

Roger was prescient about the imprecision of diagnostic criteria. A little known 2021 study of U.S. veterans who were diagnosed with opioid use disorder (OUD) challenged how many actually had it. Researchers found that nearly 20% of veterans with OUD used prescription opioids without any signs of abuse and evidence was lacking in another 7% of cases. Less than 60% of the veterans had a “high likelihood” of being correctly diagnosed with OUD.

Should Suboxone Be Used to Treat Kratom Addiction?

By Pat Anson, PNN Editor

A man with a history of substance abuse – including addiction to kratom – has been successfully treated with buprenorphine/naloxone (Suboxone), according to a case study published in the journal Cureus.  Suboxone is a medication that is normally used to treat opioid use disorder.

Kratom is not derived from the opium poppy and is not an opioid. It’s an herbal supplement that comes from the leaves of a tree in southeast Asia, where it has been used for centuries as a stimulant and pain reliever. In recent years, millions of Americans have discovered kratom and use it to self-treat their pain, anxiety, depression and addiction.

The unidentified patient in the case study has a history of using cocaine, marijuana and alcohol, and suffers from anxiety and depression. He was introduced to kratom 12 years ago by his brother for stress relief and as a substitute for oxycodone. Over the years, the patient used more and more kratom, at one point spending up to $600 a week on kratom supplements.

After several failed attempts to wean himself off kratom, which resulted in severe withdrawal symptoms, the patient went to see his primary care physician, Dr. Paul Remick, one of the study’s co-authors. It was Remick who suggested that Suboxone might help him quit kratom.

“He’d been struggling with depression, anxiety, all these various issues. He was pretty reluctant to try therapy like Alcoholics Anonymous or trying to speak to a therapist,” explained lead author Martin Arhin, a medical student at the University of North Carolina at Chapel Hill. “Dr. Remick suggested Suboxone, since kratom has some like opioid-like properties. He felt like it could potentially work. And fortunately, it did.”

After 23 weeks of using Suboxone, the patient’s withdrawal symptoms subsided and he stopped using kratom. He’s also been successfully tapered off Suboxone, a drug that many people wind up taking for life.   

Suboxone is only approved for opioid use disorder and there is no clinical evidence that it can treat kratom addiction. Such a use, while legal, would be considered “off-label” by the FDA. But based on this one anecdotal case, Arhin and his co-authors say Suboxone could be a treatment for kratom dependence.

“Currently, there is no established evidence-based consensus for the treatment of kratom addiction and withdrawal, leaving individual providers to decide on the appropriate course of action,” they wrote. “We recognized the patient's dependency on kratom and subsequently implemented a treatment plan utilizing buprenorphine/naloxone, which effectively alleviated withdrawal symptoms and supported the patient's abstinence from kratom. We suggest that this drug combination may be a potential treatment for kratom addiction.”

‘Kratom Saved My Life’

Ironically, many people use kratom as an alternative to Suboxone. In a 2016 PNN survey of over 6,100 kratom users, nearly ten percent said they used kratom primarily as a treatment for opioid addiction. Most said it was very effective (91%) in easing their withdrawal symptoms and worked better than Suboxone, with fewer side effects.

“Kratom saved my life. I tried every other type of treatment for drug addiction over the past 10 years. Subutex, methadone, total abstinence and the 12 step program. Each time I failed. After 2 years of Suboxone, I stopped treatment and began using kratom,” one respondent told us.

“Because of kratom, I no longer have to worry about heroin (or methadone or Suboxone) making me sick. I've been clean for 2 years. I can hold a job now, and I only use it when I need pain relief or need to relax,” another respondent wrote.

“I became hooked on oxycodone and had to take Suboxone to get off it. The problem is Suboxone withdrawals were nearly as bad, so I used kratom to cure that,” another patient said.

“Kratom truly saved my life. I've always suffered from extreme anxiety, but it has decreased drastically since taking it. Withdrawals from opiates and Suboxone are awful. I would not have been able to get clean without kratom. I'm confident in saying that if you make kratom illegal, the number of overdoses will rise,” wrote another kratom user.

The DEA and FDA have tried to make kratom illegal by having it declared a Schedule I controlled substance. So far, those efforts have failed due to a public backlash.

Kratom is sold legally in most U.S. states, but a handful of states and cities have banned it over concerns about addiction and overdoses.  About 100 deaths nationwide have been linked to kratom use, but in the vast majority of cases other drugs and illicit substances were involved.

About two million Americans use kratom, primarily to treat chronic pain. 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.

Although many people use kratom to self-treat opioid addiction and ease withdrawal symptoms, the FDA won’t allow kratom vendors to advertise or promote kratom for addiction treatment or any other medical purpose. This month, the FDA sent a warning letter to the Sunshine Trading Company in Colorado, warning it to stop promoting its kratom products for “opiate withdrawal.”

“You market kratom products for the treatment or cure of opioid addiction and withdrawal symptoms. However, these products have not been determined by FDA to be safe and effective for these (or any other) uses. Further, the unproven treatments could cause patients to forego or delay FDA-approved treatments for opioid addiction or withdrawal,” the FDA said.

In recent years, several other kratom vendors have received similar warning letters from the agency..