What Young People Learn to Think About Chronic Pain

By Pat Anson, PNN Editor

Did your chronic pain start during childhood?  If so, what did you think or do about it?

Did your body change when you felt pain for a long time? What is the most important thing you learned about pain? Why do you think humans have a biological system that creates pain?

Those are some of the questions an international team of researchers asked a group of 17 young adults in the U.S. and Canada who had chronic pain as children (aged 11-17 years). Participants had a range of pain conditions, such as headaches and musculoskeletal pain, and experienced pain for at least six months.

Their answers, recently published in the European Journal of Pain, provide insights into what young people think about pain and how they learned to adapt to it. Researchers say they could help debunk myths about pain and improve pain management for adults, as well as children.

“If we can identify what young people think about pain, we can figure out which beliefs are helpful, and which are not. Then we can use this knowledge to make better pain education for young people, so they understand why to engage in best-practice treatments,” says lead author Hayley Leake, PhD, a  physiotherapist and researcher at the University of South Australia. “It is important to challenge beliefs about pain that don’t align with modern pain science.”

In their interviews, Leake and her colleagues found that young people tend to think about chronic pain in one of four ways:

1. Something is wrong with their body

2. Caused by an injury that has not healed

3. Nerves ‘firing’ when they should not

4. An overactive stress system

The 17 young adults have some sophisticated and nuanced views about chronic pain. Far from being meaningless or “all in their heads,” many view pain as a sign of an undiscovered problem in the body.

“I think when we have pain in other areas, like the back, and it's there for no reason, I really do wonder if there's something going on in the body that's not good that hasn't been detected. Like soreness of a neck should be if the person slept wrong that blood flow will get cut off, sometimes that just happens. But if someone is often sore, then I think something is not quite right in the body.”   

‘No One Really Cared Enough’

Even as children, participants experienced stigma and disbelief – sometimes from their own families – when their pain didn’t respond to treatment. This was perceived by the young person as a lack of empathy, which could have bad implications for family relationships.

“I became hyper aware of my pain and drove my family crazy anytime I had pain because I wanted to know what was causing it. Then I figured out that that was going to be exhausting, and no one really cared enough so I stopped.“

Sadly, some learned at an early age that that their injuries may never completely heal and could become permanent. They had to learn how to live with it.

“Instead of trying to heal it, try to cope with it. Because, like, when I was younger everyone would say, ‘Oh like you're going to be over your pain before you're eighteen, like, this is only temporary.’ I wish I would have prepared myself more knowing that I would have it long term because that's my reality now.”

Many became aware that their nervous systems were “on the fritz” and sending out the wrong signals. This was described as “useless pain” or nerves that “stop working so well.”

“I'm pretty sure [nerves] get inflamed and confused and so like start firing signals that aren't actually there so it doesn't know what's happening and the body gets confused and doesn't know how to fix anything.”

“Basically, the way I explain my stomach (pain) to people is sort of like a peanut allergy in the sense that the wires are crossed a bit and it overreacts to things.”

Stress Makes Pain Worse

Some learned about the role of stress, and how emotional pain can make physical pain worse.

“Learning about pain and how the body can become stressed, and stress can lead to pain, has really helped me … When I was younger, I didn't understand how stress causes pain. I understand how stress causes pain now, and how stress can cause pain from like ‘fight or flight’ mode or adrenalin in your body.”

“I noticed that when I am in more stressful situations or more focused on the pain it feels like ten times worse and there is just nothing I can do about it. So by being in a stressful situation I feel tense. I am angry, uptight, and it's not doing much for my physical pain because I'm tensing up which is causing my muscles to hurt.”

Understanding the link between stress and pain helped some learn how to manage their pain. They use psychological techniques to reduce stress, such as relaxation and deep breathing exercises.

“I feel like I have a better understanding of what causes the pain… I'm more efficient about the way that I treat it and have a better grasp of not everything requires medication now that I understand exactly kind of what is going on about the pain. I just know that I don't always have to take something. I can breathe through it because it can be tied to emotions or your hormones and stuff like that.”

The interviews with 17 young people are part of a larger, six-year study of 229 children with chronic pain who were followed into adulthood. Of the original group, over 82% still report having chronic pain as adults.

Researchers are now developing a toolkit to spread awareness about childhood chronic pain to share on social media and in schools.

“Educating teenagers and young adults – as well as their parents and caregivers – about chronic pain and talking to them in the words and phrases they use and understand, is a first step to change,” says Leake. “We know when adults with chronic pain learn about pain, they improve more than those who don’t learn about pain, and that they find pain education valuable.”

Finding Hope in Possibilities

By Mia Maysack, PNN Columnist

My journey in advocacy began and revolved around healthcare reform. I’ve since stepped back from that pursuit, the main reason being that the medical-industrial complex isn’t the only system in need of dismantling. It didn’t make sense for me to focus solely on one aspect, but rather all of them, and the ways in which they are polluting the same corrupted river.

My efforts started out fixated on neurological disorders, because that’s what I’ve endured for most of my life. But I believe each diagnosis matters equally, and whether I’m able to personally relate to them has always been irrelevant to me. I still care about everybody’s dignity and I believe most patients appreciate my efforts.  

I’ve met some of my absolute favorite individuals through this work, but a large percentage remain stuck in their grief and mourning or wrapped up in their pain identity. I get that because I’ve been there.

Despite my patience and understanding, that’s often not what I receive in return.  I’m thankful for the inner work I’ve done, which provides strength for me to withstand those who so boldly mistreat me. I also understand that it is more about them and their inner climate than me. That doesn’t mean I am better than anyone, but that I operate from the bigger picture.

Despite having every reason a person could think of to give up, I have not. What I offer the pain community is a new way of thinking: hope in the possibility of brighter days ahead. 

I’ll never understand why some choose to remain miserable when they don’t have to. It doesn’t make sense to me how people can sit and complain about not being well enough to call a legislator or advocate for themselves, but devote so much energy and time into diminishing those of us who try to turn our misfortune into something that all are able to benefit from.

What hurts more than the attempted character assassination is the fact that we continue losing so many to suicide, not just in the pain community but the world around us. I reflect on how the cruelty I’ve endured could be the last thing someone encounters before they choose to just finally throw in the towel. It’s infuriating because it means we’re essentially playing a role in murder.

I am sorry if your life experiences have led you to feel as though the only thing you’re able to do is to attempt to hurt other people. I know that those frustrations are not to be taken personally, but stem from the doctors, trial and error treatments, and the broken society that has failed us. 

You should know that I’m strong enough to lovingly receive the hate, but not everybody else is. Please think twice next time you are compelled to try ripping someone else into shreds. Ask yourself, does it really make you feel any better?  

When I say “get well soon” -- as I did in my last column -- I wholeheartedly meant it.  I’m living proof that it’s possible, and no one gets to belittle or reduce that in any way. If and when you’re ready to come out of the darkness, I’ll still be here.

Mia Maysack lives with chronic migraine, cluster headache and fibromyalgia. She is the founder of Keepin’ Our Heads Up, a Facebook advocacy and support group, and Peace & Love, a wellness and life coaching practice for the chronically ill. 

Hypnosis Works Better Than Prayer as Pain Reliever

By Pat Anson, PNN Editor

When it comes to relieving acute pain, praying to God for help isn’t nearly as effective as a single session of hypnosis or mindfulness meditation, according to an unusual new study.

Intrigued by research that found Muslim prayer rituals reduce pain, an international team of researchers recruited 232 healthy adults in Portugal to further study the effects of spirituality on pain.

Short-term acute pain was induced in all participants by wrapping their arms and hands in a cold compress for up to 5 minutes. After a rest period, participants listened to either a 20-minute recording of guided hypnosis, mindfulness meditation, or a passage from the New Testament followed by a short Christian prayer. A fourth group listened to a reading from a natural history book and served as a control group.

After listening to the recordings, acute pain was induced again with a cold compress, while participants had their pain intensity, pain tolerance, cardiac function and stress levels monitored.

The study findings, recently published in the Journal of Pain Research, show that hypnosis was effective in lowering pain intensity and raising pain tolerance, followed closely by mindfulness meditation. The benefits from Christian prayer (CP) were small and not considered statistically significant.

“The findings suggest that both single short-term hypnosis and mindfulness meditation training, but not biblical-based CP, may be viable options for effective acute pain self-management,” researchers reported. “The findings also suggest that hypnosis might be slightly more efficacious than mindfulness meditation, at least in the short-term, and perhaps especially among novice individuals with very limited hypnosis or meditation practice/training.”

The research team was somewhat surprised by the lack of results for Christian prayer, and think it may have been due to the complexity of the bible-based prayer. A shorter, simpler form of prayer may have worked better. Another factor was that only a third of the study participants described themselves as Christian, while a third said they were atheists or agnostics.

“It is therefore possible that the prayer used in this study might have had a larger beneficial effect among those describing themselves as Christian than those describing themselves as being in one of the non-Christian groups and have had little (or even opposite) effect on atheists and agnostics. For the latter, prayer might have been bothering or even distressing, leading the individuals to focus more on the pain and on the distress caused by prayer itself,” researchers said.

Could Hypnosis Replace Opioids?

Previous studies have found that hypnosis and mindfulness can reduce acute pain in hospitalized patients, and that hypnosis can relieve chronic pain for patients with irritable bowel syndrome (IBS), complex regional pain syndrome (CRPS) and other intractable pain conditions.

A new study published in The Journal of Molecular Diagnostics even suggests that hypnosis can be an alternative to opioids in relieving post-operative pain.

Researchers at Stanford University say genetics play a role in “hypnotizability” — the tendency of some people to respond to hypnosis more than others — and developed a molecular diagnostic tool to identify individuals who would benefit from hypnosis through their blood and saliva samples. They believe the tool could be used as a “point-of-care” test in a hospital setting to determine how patients are treated for pain. Depending on the test results, a patient recovering from surgery could get “hypnotic analgesia” as an adjunct or alternative to pain medication.

“It is a step towards enabling researchers and healthcare professionals to identify a subset of patients who are most likely to benefit from hypnotic analgesia,” said co-lead investigator Jessie Markovits, MD, Department of Internal Medicine, Stanford School of Medicine.

“Precision medicine has made great strides in identifying differences in drug metabolism that can impact medication decisions for perioperative pain. We hope to provide similar precision in offering hypnosis as an effective, non-pharmacological treatment that can improve patient comfort while reducing opioid use.”

New CDC Guideline: Too Little, Too Late for Chronic Pain Patients

By Sam Whitehead and Andy Miller, Kaiser Health News

Jessica Layman estimates she has called more than 150 doctors in the past few years in her search for someone to prescribe opioids for her chronic pain.

“A lot of them are straight-up insulting,” said the 40-year-old, who lives in Dallas. “They say things like ‘We don’t treat drug addicts.’”

Layman has tried a host of non-opioid treatments to help with the intense daily pain caused by double scoliosis, a collapsed spinal disc, and facet joint arthritis. But she said nothing worked as well as methadone, an opioid she has taken since 2013.

The latest phone calls came late last year, after her previous doctor shuttered his pain medicine practice, she said. She hopes her current doctor won't do the same. “If something should happen to him, there's nowhere for me to go,” she said.

Layman is one of the millions in the U.S. living with chronic pain. Many have struggled to get opioid prescriptions written and filled since 2016 guidelines from the Centers for Disease Control and Prevention inspired laws cracking down on doctor and pharmacy practices. The CDC recently updated those recommendations to try to ease their impact, but doctors, patients, researchers, and advocates say the damage is done.

“We had a massive opioid problem that needed to be rectified,” said Antonio Ciaccia, president of 3 Axis Advisors, a consulting firm that analyzes prescription drug pricing. “But the federal crackdowns and guidelines have created collateral damage: patients left high and dry.”

Born of an effort to fight the nation’s overdose crisis, the guidance led to legal restrictions on doctors’ ability to prescribe painkillers. The recommendations left many patients grappling with the mental and physical health consequences of rapid dose tapering or abruptly stopping medication they’d been taking for years, which carries risks of withdrawal, depression, anxiety, and even suicide.

Opioid Guideline Revised

In November, the agency released new guidelines, encouraging physicians to focus on the individual needs of patients. While the guidelines still say opioids should not be the go-to option for pain, they ease recommendations about dose limits, which were widely viewed as hard rules in the CDC’s 2016 guidance. The new standards also warn doctors about risks associated with rapid dose changes after long-term use.

But some doctors worry the new recommendations will take a long time to make a meaningful change — and may be too little, too late for some patients. The reasons include a lack of coordination from other federal agencies, fear of legal consequences among providers, state policymakers hesitant to tweak laws, and widespread stigma surrounding opioid medication.

The 2016 guidelines for prescribing opioids to people with chronic pain filled a vacuum for state officials searching for solutions to the overdose crisis, said Dr. Pooja Lagisetty, an assistant professor of medicine at the University of Michigan Medical School.

The dozens of laws that states passed limiting how providers prescribe or dispense those medications, she said, had an effect: a decline in opioid prescriptions even as overdoses continued to climb.

The first CDC guidelines “put everybody on notice,’’ said Dr. Bobby Mukkamala, chair of the American Medical Association’s Substance Use and Pain Care Task Force. Physicians reduced the number of opioid pills they prescribe after surgeries, he said. The 2022 revisions are “a dramatic change,” he said.

The human toll of the opioid crisis is hard to overstate. Opioid overdose deaths have risen steadily in the U.S. in the past two decades, with a spike early in the covid-19 pandemic. The CDC says illicit fentanyl has fueled a recent surge in overdose deaths.

Taking into account the perspective of chronic pain patients, the latest recommendations try to scale back some of the harms to people who had benefited from opioids but were cut off, said Dr. Jeanmarie Perrone, director of the Penn Medicine Center for Addiction Medicine and Policy.

“I hope we just continue to spread caution without spreading too much fear about never using opioids,” said Perrone, who helped craft the CDC’s latest recommendations.

Christopher Jones, director of the CDC’s National Center for Injury Prevention and Control, said the updated recommendations are not a regulatory mandate but only a tool to help doctors “make informed, person-centered decisions related to pain care.”

Multiple studies question whether opioids are the most effective way to treat chronic pain in the long term. But drug tapering is associated with deaths from overdose and suicide, with risk increasing the longer a person had been taking opioids, according to research by Dr. Stefan Kertesz, a professor of medicine at the University of Alabama-Birmingham.

He said the new CDC guidance reflects “an extraordinary amount of input” from chronic pain patients and their doctors but doubts it will have much of an impact if the FDA and the Drug Enforcement Administration don’t change how they enforce federal laws.

Patients Still Not Getting Needed Medication

The FDA approves new drugs and their reformulations, but the guidance it provides for how to start or wean patients could urge clinicians to do so with caution, Kertesz said. The DEA, which investigates physicians suspected of illegally prescribing opioids, declined to comment.

The DEA’s pursuit of doctors put Danny Elliott of Warner Robins, Georgia, in a horrible predicament, said his brother, Jim.

In 1991, Danny, a pharmaceutical company rep, suffered an electric shock. He took pain medicine for the resulting brain injury for years until his doctor faced federal charges of illegally dispensing prescription opioids, Jim said.

Danny turned to doctors out of state — first in Texas and then in California. But Danny’s latest physician had his license suspended by the DEA last year, and he couldn’t find a new doctor who would prescribe those medications, Jim said.

Danny, 61, and his wife, Gretchen, 59, died by suicide in November. “I’m really frustrated and angry about pain patients being cut off,” Jim said.

Danny became an advocate against forced drug tapering before he died. Chronic pain patients who spoke with KHN pointed to his plight in calling for more access to opioid medications.

DANNY AND GRETCHEN ELLIOT

Even for people with prescriptions, it’s not always easy to get the drugs they need.

Pharmacy chains and drug wholesalers have settled lawsuits for billions of dollars over their alleged role in the opioid crisis. Some pharmacies have seen their opioid allocations limited or cut off, noted Ciaccia, with 3 Axis Advisors.

Rheba Smith, 61, of Atlanta, said that in December her pharmacy stopped filling her prescriptions for Percocet and MS Contin. She had taken those opioid medications for years to manage chronic pain after her iliac nerve was mistakenly cut during surgery, she said.

Smith said she visited nearly two dozen pharmacies in early January but could not find one that would fill her prescriptions. She finally found a local mail-order pharmacy that filled a one-month supply of Percocet. But now that drug, along with MS Contin, are not available, the pharmacy told her.

“It has been a horrible three months. I have been in terrible pain,” Smith said.

Many patients fear a future of constant pain. Layman thinks about the lengths she’d go to in order to get medication.

“Would you be willing to buy drugs off the street? Would you be willing to go to an addiction clinic and try to get pain treatment there? What are you willing to do to stay alive?” she said. “That is what it comes down to.”

Kaiser Health News is a national newsroom that produces in-depth journalism about health issues.

FDA Approves Nasal Spray That Relieves Migraine in Minutes

By Pat Anson, PNN Editor

Pfizer will soon launch a fast-acting nasal spray that can relieve migraine pain in as little as 15 minutes for some patients. The company has received FDA approval for Zavzpret (zavegepant), the first calcitonin gene-related peptide (CGRP) inhibitor formulated into a nasal spray for the acute treatment of migraine in adults with or without aura.    

“When a migraine hits, it has a significant negative impact on a person’s daily life,” Kathleen Mullin, MD, Associate Medical Director at New England Institute for Neurology & Headache, said in a Pfizer press release. “Among my migraine patients, one of the most important attributes of an acute treatment option is how quickly it works. As a nasal spray with rapid drug absorption, Zavzpret offers an alternative treatment option for people who need pain relief or cannot take oral medications due to nausea or vomiting, so they can get back to normal function quickly.”

That’s the good news. The bad news is how expensive the nasal spray is likely to be when it becomes available in July 2023. According to a Pfizer spokesperson, Zavzpret “is expected to be comparable in price to other FDA approved CGRP migraine medicines.”

CGRP is a protein that binds to nerve receptors in the brain and dilates blood vessels, causing migraine pain. Since their introduction in 2018, CGRP inhibitors have become the biggest innovation in migraine treatment in decades, although their cost is prohibitive for many patients.

Eight doses of Nurtec, a CGRP-inhibiting tablet taken daily to prevent and treat migraine, can cost over $1,000, while the listed price for Emgality, a CGRP-inhibiting solution, is $679 for a self-injectable syringe used once a month for migraine prevention. Prices will vary for patients, depending on their insurance and whether they qualify for a patient assistance program.

In a Phase 3 study involving over 1,400 patients, recently published in The Lancet Neurology, a single 10mg dose of Zavzpret relieved migraine pain in as little as 15 – 30 minutes, and provided sustained relief for as long as 48 hours.  

An important caveat is that the nasal spray did not help everyone. Only 22.5% of patients were pain free after two hours, compared to 15.5% who were given a placebo.

The 7% difference may sound like marginal improvement in a minority of patients, but in the parlance of clinical trials it’s considered “statistically significant” improvement.  

Zavzpret was well tolerated by most patients. The most common adverse reactions after ingesting the spray were taste disorders (dysgeusia and ageusia), nausea, nasal discomfort and vomiting.

PFIZER IMAGE

“The FDA approval of Zavzpret marks a significant breakthrough for people with migraine who need freedom from pain and prefer alternative options to oral medications,” said Angela Hwang, Chief Commercial Officer and President of Pfizer’s Global Biopharmaceuticals Business.

Migraine affects about 39 million people in the United States, according to the American Migraine Foundation. In addition to headache pain, migraine can cause nausea, blurriness or visual disturbances, and sensitivity to light and sound. Women are three times more likely to suffer from migraines than men.

How TMS Helped Me Feel Better Physically and Mentally

By Madora Pennington, PNN Columnist

Chronic pain is often accompanied by depression. Many clinicians used to think that pain was caused by psychological distress, so they offered patients antidepressants with the attitude that their suffering was “all in their head.”

But now it is better understood that chronic pain can cause depression. Both conditions have a similar pathology and change the brain in similar ways. That is why treatments that work on depression (like antidepressants) may reduce the brain’s sensitivity to pain.

“Regardless of the cause of the pain, anxiety and depression increase the sensation of pain. Pain increases depression and anxiety, creating a vicious cycle. Breaking that cycle can help decrease pain,” says integrative physician and pain doctor Dr. Linda Bluestein.

I have Ehlers-Danlos Syndrome (EDS). Debilitating pain has been my companion since I was 14 years old. My body makes collagen that is not structurally sound. Because I am “loosely glued together,” I get injured easily because my joints are unstable and my body has a poor sense of where it actually is in relation to itself and the outside world. My thin and stretchy connective tissue sends pain signals to my brain, even when I am not injured.

It is probably not realistic for someone with Ehlers-Danlos to expect to have a life without pain, so I welcome medical treatments that might lessen my pain, even if they don’t eliminate it. My goal is to have pain that does not incapacitate me or ruin my life by taking all my attention. Thankfully, there are modalities that do this.

MADORA GETTING TREATMENT AT UCLA’S tms CLINIC

The last one I tried was transcranial magnetic stimulation (TMS), which stimulates the brain through a magnetic pulse which activates nerve cells and brain regions to improve mood.

TMS treatments are painless and entirely passive. The patient just sits there and lets the machine do the work. A magnetic stimulator rests against the head and pulses, which feels like tapping or gentle scratching.

TMS has been around for almost 40 years. The first TMS device was created in 1985 and the FDA approved it for major depression in 2008. Since then, its use has been expanded to include migraine, obsessive compulsive disorder, and smoking cessation.

While other medical procedures work on an injured body part, TMS targets the brain, where pain is processed. This helps the brain shift away from perceiving pain signals that are excessive and have become chronic.

“Many people are surprised to learn that stimulating the brain can help alleviate pain that is felt in an arm, leg or some other part of the body. We explain to patients that because pain is perceived in the brain, it is possible to reduce or sometimes even eliminate it by stimulating specific brain regions,” says Andrew Leucther, MD, a psychiatrist who heads UCLA’s TMS clinic, where I was treated. In addition to depression, the clinic also treats fibromyalgia, neuropathy, nerve injury, and many other causes of pain.

“Most patients are much less bothered by pain after treatment and report that they are functioning better in their work and personal lives,” Leucther told me.

Many insurers cover TMS for depression, but it is not generally covered for pain alone — although many doctors will add protocols for pain when treating depression. This is how I got my 36 sessions of TMS treatment, the usual number that insurance will cover and is thought to be effective.

Repetitive TMS stimulation to the primary motor cortex of the brain has robust support in published studies for the treatment of pain. It seems to work particularly well for migraines, peripheral neuropathic pain and fibromyalgia. Like all treatments, it may not work for everyone.

TMS practitioners recommend four or five sessions per week, gradually tapering off toward the end. My body is so sensitive, about three per week was all I could tolerate comfortably. The appointments lasted a brief 10 -15 minutes. A downside of the TMS machine is that it puts pressure against the head, which could be too much for Ehlers-Danlos patients who have uncontrolled head and neck instability.

TMS gave me relief in different ways than other methods have.  One of the first things I noticed was less negativity and rumination. It was like getting a nagging, negative person out of the room -- or rather, my head. I felt less heartbroken over the major losses of my life, such as having spent so much of it totally disabled.

I also noticed a big difference in my PTSD triggers. I found myself shrugging off situations that normally would put me in a very uncomfortable, perturbed state. Keep in mind, I was getting TMS applied to various points on my scalp for pain, depression and anxiety.

Since having TMS, I notice that my body is less sensitive to touch. From spa treatments to medical procedures, it does not hurt as much to be poked at or pressed on. The extra comfort TMS had given me, both mentally and physically, is a lot for someone with medical problems like mine that are so difficult to treat.

Madora Pennington is the author of the blog LessFlexible.com about her life with Ehlers-Danlos Syndrome. She graduated from UC Berkeley with minors in Journalism and Disability Studies. 

Study Finds Spinal Cord Stimulation Has No Benefit for Back Pain

By Pat Anson, PNN Editor

A scathing new Cochrane review is raising more questions about the safety, efficacy and long-term benefits of spinal cord stimulators, medical devices that are increasingly used to treat chronic back pain.  

Cochrane reviews are considered the gold standard in medical research because they use robust methodology to gather good quality evidence and reduce the impact of biased, poor-quality studies.

The review by Australian researchers concluded that spinal cord stimulation (SCS) works no better than a placebo for treating chronic low back pain, and provides little to no benefit in improving quality of life.

The devices are surgically placed near the spine and connected to batteries implanted under the skin, which send electrical impulses into the spine to mask pain.

“Spinal cord stimulation is invasive and has a great financial cost to people who choose surgery as a last resort to alleviate their pain. Our review found that the long-term benefits and harms are essentially unknown,” said lead author Adrian Traeger, PhD, a Research Fellow at the Institute for Musculoskeletal Health at the University of Sydney. “Our review of the clinical data suggests no sustained benefits to the surgery outweigh the costs and risks.”

Treager and his colleagues analyzed the results of 13 clinical trials of SCS devices, looking at data from almost 700 patients with low back pain. They found little to no clinical data on the long-term effectiveness of SCS because most of the studies lasted less than a month, were poorly blinded, or had selective reporting bias.

The researchers also found that side effects from SCS surgery were poorly documented, preventing them from assessing the level of risk involved. Serious adverse events include nerve damage, infection, and the devices’ electrical leads moving, all of which may lead to more surgeries.

“Data in this review do not support the use of SCS to manage low back pain outside a clinical trial. Current evidence suggests SCS probably does not have sustained clinical benefits that would outweigh the costs and risks of this surgical intervention,” they concluded. 

Findings from the Cochrane review have been submitted to Australia’s Department of Health and Aged Care, which is reviewing the effectiveness of spinal cord stimulators. The devices' long-term safety and performance are also being re-assessed by Australia's Therapeutic Goods Administration (TGA).

“Our review found that the clinical benefit of adding spinal cord stimulation to treat low back pain remains unknown. When coupled with the reality that these devices are very expensive and often break down there is clearly a problem here that should be of concern to regulators,” said Chris Maher, PhD, Co-Director of Sydney Musculoskeletal Health.

Increasing Use of Stimulators

About 50,000 spinal cord stimulators are implanted annually in the U.S. and their use is growing. The devices are no longer limited to patients with back, neck and leg pain. In 2021, the FDA expanded the use of SCS to treat chronic pain from diabetic neuropathy. Stimulators are also being used on patients with Complex Regional Pain Syndrome (CRPS).

A 2018 study by investigative journalists found that SCSs have some of the worst safety records of medical devices tracked by the FDA. A 2020 FDA review of adverse events involving stimulators found that nearly a third were reports of unsatisfactory pain relief. A more recent study found that patients with the devices did not reduce their use of opioids, and continued getting procedures such as epidurals, corticosteroid injections and radiofrequency ablation.

Although evidence is growing that questions the safety and effectiveness of SCS, medical device companies continue to roll out new stimulators with more advanced technology. This week Nevro said it would release the first SCS system in the U.S. that uses artificial intelligence to optimize pain relief for each patient. The HFX iQ SCS system is designed for patients with diabetic neuropathy or chronic back and leg pain.

"This is an exciting time in spinal cord stimulation -- better waveforms, more conditions we can treat, and a massive treasure trove of patient data," said Usman Latif, MD, an interventional pain specialist and consultant to Nevro.

“What if we could take all the programming experience and clinical outcomes of tens of thousands of patients across the country, including what programs worked and what didn't, and bring the power of all that knowledge into the palm of our patient's hand -- with them 24/7, monitoring them, and offering them the best program for their exact situation with a tap on the screen. HFX iQ is the future of medicine, where expanded data holds the promise of new capabilities and improved care."

In addition to the U.S. release of HFX iQ, Nevro has asked for approval from regulators in Europe and Australia.

Despite Pharma Claims, FDA Finds Few Rx Opioids Entering U.S. Illegally

By Phil Galewitz, Kaiser Health News

For years, the FDA has defended its efforts to intercept prescription drugs coming from abroad by mail as necessary to keep out dangerous opioids, including fentanyl.

The pharmaceutical industry frequently cites such concerns in its battle to stymie numerous proposals in Washington to allow Americans to buy drugs from Canada and other countries where prices are almost always much lower.

But the agency’s own data from recent years on its confiscation of packages containing drugs coming through international mail provides scant evidence that a significant number of opioids enters this way. In the two years for which KHN obtained data from the agency, only a tiny fraction of the drugs inspected contained opioids.

The overwhelming majority were uncontrolled prescription drugs that people had ordered, presumably because they can’t afford the prices at home.

The FDA still stops those drugs, because they lack U.S. labeling and packaging, which federal authorities say ensure they were made under U.S. supervision and tracking.

The FDA said it found 33 packages of opioids and no fentanyl sent by mail in 2022 out of nearly 53,000 drug shipments its inspectors examined at international mail facilities. That’s about 0.06% of examined packages.

According to a detailed breakdown of drugs intercepted in 2020, the lion’s share of what was intercepted — and most often destroyed — was pharmaceuticals. The No. 1 item was cheap erectile dysfunction pills, like generic Viagra. But there were also prescribed medicines to treat asthma, diabetes, cancer, and HIV.

U.S. CUSTOMS AND BORDER PROTECTION IMAGE

FDA spokesperson Devin Koontz said the figures don’t reflect the full picture because U.S. Customs and Border Protection is the primary screener at the mail facilities.

But data obtained from the customs agency shows it likewise found few opioids: Of more than 30,000 drugs it intercepted in 2022 at the international mail facilities, only 111 were fentanyl and 116 were other opioids.

Americans Pay Twice the Price

On average, Americans pay more than twice the price for exactly the same drugs as people in other countries. In polling, 7% of U.S. adults say they do not take their medicines because they can’t afford them. About 8% admit they or someone else in their household has ordered medicines from overseas to save money, though it is technically illegal in most cases. At least four states — Florida, Colorado, New Hampshire, and New Mexico — have proposed programs that would allow residents to import drugs from Canada.

While the FDA has found only a relatively small number of opioids, including fentanyl, in international mail, Congress gave the agency a total of $10 million in 2022 and 2023 to expand efforts to interdict shipments of opioids and other unapproved drugs.

“Additional staffing coupled with improved analytical technology and data analytics techniques will allow us to not only examine more packages but will also increase our targeting abilities to ensure we are examining packages with a high probability of containing violative products,” said Dan Solis, assistant commissioner for import operations at the FDA.

But drug importation proponents worry the increased inspections targeting opioids will result in more uncontrolled substances being blocked in the mail.

“The FDA continues to ask for more and more taxpayer money to stop fentanyl and opioids at international mail facilities, but it appears to be using that money to refuse and destroy an increasing number of regular international prescription drug orders,” said Gabe Levitt, president of PharmacyChecker.com, which accredits foreign online pharmacies that sell medicines to customers in the U.S. and worldwide. “The argument that importing drugs is going to inflame the opioid crisis doesn’t make any sense.”

“The nation’s fentanyl import crisis should not be conflated with safe personal drug importation,” Levitt said.

He was not surprised at the low number of opioids being sent through the mail: In 2022, an organization he heads called Prescription Justice received 2020 FDA data through a Freedom of Information Act request. It showed that FDA inspectors intercepted 214 packages with opioids and no fentanyl out of roughly 50,000 drug shipments.

In contrast, they found nearly 12,000 packages containing erectile dysfunction pills. They also blocked thousands of packages containing prescription medicines to treat a host of other conditions.

Over 90% of the drugs found at international mail facilities are destroyed or denied entry into the United States, FDA officials said.

In 2019, an FDA document touted the agency’s efforts to stop fentanyl coming into the United States by mail amid efforts to stop other illegal drugs.

“Importing drugs from abroad simply for cost savings is not a good enough reason to expose yourself to the additional risks. The drug may be fine, but we don’t know, so we assume it is not.”

— Devin Koontz, FDA

Levitt was pleased that Congress in December added language to a federal spending bill that he said would refocus the FDA mail inspections. It said the “FDA’s efforts at International Mail Facilities must focus on preventing controlled, counterfeit, or otherwise dangerous pharmaceuticals from entering the United States. Further, funds made available in this Act should prioritize cases in which importation poses a significant threat to public health.”

Levitt said the language should shift the FDA from stopping shipments containing drugs for cancer, heart conditions, and erectile dysfunction to blocking controlled substances, including opioids.

But the FDA’s Koontz said the language won’t change the type of drugs FDA inspectors examine, because every drug is potentially dangerous. “Importing drugs from abroad simply for cost savings is not a good enough reason to expose yourself to the additional risks,” he said. “The drug may be fine, but we don’t know, so we assume it is not.”

He said even drugs that are made in the same manufacturing facilities as drugs intended for sale in the United States can be dangerous because they lack U.S. labeling and packaging that ensure they were made properly and handled within the U.S. supply chain.

FDA officials say drugs bought from foreign pharmacies are 10 times as likely to be counterfeit as drugs sold in the United States.

To back up that claim, the FDA cites congressional testimony from a former agency official in 2005 who — while working for a drug industry-funded think tank — said between 8% and 10% of the global medicine supply chain is counterfeit.

The FDA said it doesn’t have data showing which drugs it finds are unsafe counterfeits and which drugs lack proper labeling or packaging. The U.S. Customs and Border Protection data shows that, among the more than 30,000 drugs it inspected in 2022, it found 365 counterfeits.

Pharmaceutical Research and Manufacturers of America, the trade group for the industry, funds a nonprofit advocacy organization called Partnership for Safe Medicines, which has run media campaigns to oppose drug importation efforts with the argument that it would worsen the fentanyl epidemic.

Shabbir Safdar, executive director of the Partnership for Safe Medicines, a group funded by U.S. pharmaceutical manufacturers, said he was surprised the amount of fentanyl and opioids found by customs and FDA inspectors in the mail was so low. He said that historically it has been a problem, but he could not provide proof of that claim.

He said federal agencies are not inspecting enough packages to get the full picture. “With limited resources we may be getting fooled by the smugglers,” he said. “We need to be inspecting the right 50,000 packages each year.”

Big Pharma’s Drug Monopoly

For decades, millions of Americans seeking to save money have bought drugs from foreign pharmacies, with most sales done online. Although the FDA says people are not allowed to bring prescription drugs into the United States except in rare cases, dozens of cities, county governments, and school districts help their employees buy drugs from abroad.

The Trump administration said in 2020 that drugs could be safely imported and opened the door for states to apply to the FDA to start importation programs. But the Biden administration has yet to approve any.

A federal judge in February threw out a lawsuit filed by PhRMA and the Partnership for Safe Medicines to block the federal drug importation program, saying it’s unclear when, if ever, the federal government would approve any state programs.

“The pharmaceutical industry is using the FDA to protect their price monopoly to keep their prices high.”

— Alex Lawson, Social Security Works

Levitt and other importation advocates say the process is often safe largely because the drugs being sold to people with valid prescriptions via international mail are FDA-approved drugs with labeling different from that found at U.S. pharmacies, or foreign versions of FDA-approved drugs made at the same facilities as drugs sold in the U.S. or similarly regulated facilities. Most drugs sold at U.S. pharmacies are already produced abroad.

Because of the sheer volume of mail, even as the FDA has stepped up staffing at the mail facilities in recent years, the agency can physically inspect fewer than 1% of packages presumed to contain drugs, FDA officials said.

Solis said the agency targets its interdiction efforts to packages from countries from which it believes counterfeit or illegal drugs are more likely to come.

Advocates for importation say efforts to block it protect the pharmaceutical industry’s profits and hurt U.S. residents trying to afford their medicines.

“We have never seen a rash of deaths or harm from prescription drugs that people bring across the border from verified pharmacies, because these are the same drugs that people buy in American pharmacies,” said Alex Lawson, executive director of Social Security Works, which advocates for lower drug prices. “The pharmaceutical industry is using the FDA to protect their price monopoly to keep their prices high.”

Kaiser Health News is a national newsroom that produces in-depth journalism about health issues.

A Pained Life: Me and My Shadow

By Carol Levy, PNN Columnist

Pain shadows a lot of life's experiences. If I'm pregnant, at some point I'll think about childbirth – and the horrendous pain of labor. But to torture a musical metaphor, at the end of the shadow, the sun will come out tomorrow. At the end of labor, the pain stops, and the happiness of a newborn baby is the result.

If I'm going to have surgery, I may think about the pain that comes after surgery and during recuperation. But I can also be buoyed by the knowledge that at the end of my recovery, the pain of what brought me to a surgeon in the first place and the pain of getting over the operation will be gone.

When I have an appointment with a dentist, just thinking about the appointment is painful for me. The visit means triggering my trigeminal neuralgia facial pain as soon as they ask me to “open wide.”

There will be no sun, just shadows. The appointment will end, but the pain that was triggered will last for hours. I can’t run away from it.

Another dental appointment will have to be made, hopefully later rather than sooner, and I will be forced to invite the pain back again.

Is the pain awful when it is triggered or is it the fear of it being triggered that sets it off? Some doctors will say it is psychological and that fear is causing the pain, not the actual actions that trigger it.

Is this true? Sometimes I like to think it is. After all, if it is fear, then I can try and work on it in my mind, to release myself from its prison. If it is the pain, and when or how they will set it off, I cannot talk myself out of it.

There is no way to negate the reality of the pain or its triggers. The sun does not come out for us and the shadow of fear is not a metaphor. Pain is our reality. The fear of setting it off can be as dark as the pain itself.

That’s something that we and our doctors, colleagues, family and friends need to understand and accept as the truth of our life experience. And the reason we are often unable to participate in life.

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.

Long Covid Raises Risk of Heart Problems

By Pat Anson, PNN Editor

Headaches, fatigue, shortness of breath, and cognitive problems are common symptoms of Long COVID, a persistent and puzzling illness that can linger for months or years after the initial COVID-19 infection.     

Two new studies being presented at the American College of Cardiology’s Annual Scientific Session suggest that people with Long COVID may also be at risk of long-term cardiovascular problems.

“COVID-19 is more than a simple respiratory disease — it is a syndrome that can affect the heart,” said Joanna Lee, a medical student at David Tvildiani Medical University and scholar at the Global Remote Research Scholars Program (GRRSP). “Clinicians should be aware that cardiac complications can exist and investigate further if a patient complains of these symptoms, even a long time after contracting COVID-19.”

Lee and her colleagues reviewed findings from 11 major studies involving 5.8 million people, in what’s believed to be the largest effort to date to examine cardiovascular complications from long COVID. They found that Long COVID more than doubles a person’s risk of developing cardiac complications compared to a control group.

Researchers did not investigate what caused the association between Long COVID and heart complications, but they suspect that chronic inflammation plays a role. People with Long Covid often have persistently high inflammatory markers – something healthcare providers should be alert to.

“Coordinated efforts among primary care providers, emergency room staff and cardiologists could help with early detection and mitigation of cardiac complications among long COVID patients,” Lee said. “For patients, if you had COVID-19 and you continue to have difficulty breathing or any kind of new heart problems, you should go to the doctor and get it checked out.”

In the second study, researchers at Intermountain Health in Salt Lake City looked at health data for nearly 150,000 patients who tested positive for COVID-19, and found that even those with mild symptoms had significantly higher rates of chest pain six months to a year after the initial infection. But there was no increase in heart attacks or other cardiovascular events.

“While we didn’t see any significant rates of major events like heart attack or stroke in patients who had an initial mild initial infection, we did find chest pains to be a persistent problem, which could be a sign of future cardiovascular complications,” said lead author Heidi May, PhD, a cardiovascular epidemiologist at Intermountain Health. 

A third study, recently published in JAMA Health Forum, supports many of these findings. Researchers at Elevance Health in Indiana compared more than 13,000 Long COVID patients to a control group of 26,000 people without COVID. Those with Long COVID had significantly higher rates of cardiac arrhythmia, blood clots, stroke, coronary artery disease, heart failure, asthma and mortality.

Notably, nearly 3 out of 4 had only mild COVID symptoms and were not hospitalized during the initial infection, suggesting that the health of all COVID patients needs to be monitored long-term.

“From a health policy perspective, these results also indicate a meaningful effect on future health care utilization, and even potential implications for labor force participation,” researchers said.

About one in every five patients infected with COVID-19 develops symptoms of Long COVID. A recent study found that COVID vaccines appear to significantly reduce the risk of getting Long COVID.

The CDC estimates there were 103 million confirmed U.S. cases of COVID-19, resulting in 1.13 million deaths.

Injection of Donor Cells Gives Long-Term Relief from Degenerative Disc Disease

By Pat Anson, PNN Editor

A single injection of cells and fluid derived from human donor tissue was successful long-term in relieving pain and restoring physical function in patients with degenerative disc disease, according to new research presented at the annual meeting of the Society of Interventional Radiology in Phoenix.

The injections, known as viable disc allograft supplementation, encourage cells in damaged discs to regenerate with healthy tissue. Degenerative disc disease is one of the leading causes of chronic lower back pain.

“The significant improvement in pain and function is promising for patients living with chronic low back pain – a condition that can greatly impact a person’s quality of life,” said lead author Douglas Beall, MD, chief of radiology at Clinical Radiology of Oklahoma. “Back pain is the leading cause of limited activity and workplace absenteeism. This treatment may help patients return to a normal activity level for a longer period time.”

Fifty patients participated in the VAST trial, with 46 patients receiving allograft treatment and four receiving saline injections as a placebo. VIVEX Biologics, a regenerative medicine company that processes donated cells and tissue to treat musculoskeletal injuries, wounds and burns, sponsored the study.

After three years, 60 percent of patients who received allograft treatment reported more than 50% improvement in pain and 70% had significant improvement in their function scores. No patients suffered adverse effects.

In healthy patients, discs cushion the spine’s vertebrae, facilitating movement and flexibility. But discs can wear out over time and cause the bones of the spine to rub together and pinch nerves, causing pain and disability. By age 60, most people have at least some disc degeneration.

“Existing treatment for chronic low back pain due to degenerative disc disease is often ineffective or the effects are short-lived,” said Beall, who is a medical consultant for VIVEX. “We need better treatments for this condition since conservative care is not providing the long-term outcomes that patients deserve. Injectable allograft treatment might be the answer for many people.”

Beall says allograft injections could decrease the use of pain medication by patients with chronic lower back pain. The treatment requires no incisions and patients are able to go home on the same day.

Other companies are also developing new injections to treat degenerative disc disease. In clinical trials, Australia-based Mesoblast says injections of its proprietary stem cell product provided long-term relief for people with lower back pain caused by disc disease. The company recently announced the FDA designated its stem cell injection as a Regenerative Medicine Advanced Therapy, which is designed to help speed up its development.   

Injections of an experimental gel developed by ReGelTec also show promise as a treatment for disc disease. The hydrogel is heated before injection to more easily fill cracks and tears in the affected discs. When the gel cools and hardens, it helps restore the disc’s structural integrity.   

Our Bodies Produce Chemicals Similar to THC in Cannabis

By Drs. Prakash and Mitzi Nagarkatti, University of South Carolina

Over the past two decades, a great deal of attention has been given to marijuana – also known as pot or weed. As of early 2023, marijuana has been legalized for recreational use in 21 states and Washington, D.C., and the use of marijuana for medical purposes has grown significantly during the last 20 or so years.

But few people know that the human body naturally produces chemicals that are very similar to delta-9-tetrahydrocannabinol, or THC, the psychoactive compound in marijuana, which comes from the Cannabis sativa plant. These substances are called endocannabinoids, and they’re found across all vertebrate species.

Evolutionarily, the appearance of endocannabinoids in vertebrate animals predates that of Cannabis sativa by about 575 million years.

It is as if the human body has its own version of a marijuana seedling inside, constantly producing small amounts of endocannabinoids.

The similarity of endocannabinoids to THC, and their importance in maintaining human health, have raised significant interest among scientists to further study their role in health and disease, and potentially use them as therapeutic targets to treat human diseases.

THC was first identified in 1964, and is just one of more than 100 compounds found in marijuana that are called cannabinoids.

What Are Endocannabinoids?

Endocannabinoids were not discovered until 1992. Since then, research has revealed that they are critical for many important physiological functions that regulate human health. An imbalance in the production of endocannabinoids, or in the body’s responsiveness to them, can lead to major clinical disorders, including obesity as well as neurodegenerative, cardiovascular and inflammatory diseases.

We are immunologists who have been studying the effects of marijuana cannabinoids and vertebrate endocannabinoids on inflammation and cancer for more than two decades. Research in our laboratory has shown that endocannabinoids regulate inflammation and other immune functions.

A variety of tissues in the body, including brain, muscle, fatty tissue and immune cells, produce small quantities of endocannabinoids. There are two main types of endocannabinoids: anandamide, or AEA, and 2-arachidonoyl glycerol, known as 2-AG. Both of them can activate the body’s cannabinoid receptors, which receive and process chemical signals in cells.

One of these receptors, called CB1, is found predominantly in the brain. The other, called CB2, is found mainly in immune cells. It is primarily through the activation of these two receptors that endocannabinoids control many bodily functions.

The receptors can be compared to a “lock” and the endocannabinoids a “key” that can open the lock and gain entry into the cells. All these endocannabinoid receptors and molecules together are referred to as the endocannabinoid system.

The cannabis plant contains another compound called cannabidiol, or CBD, which has become popular for its medicinal properties. Unlike THC, CBD doesn’t have psychoactive properties because it does not activate CB1 receptors in the brain. Nor does it activate the CB2 receptors, meaning that its action on immune cells is independent of CB2 receptors.

Endocannabinoids Help Us Feel Better

The euphoric “high” feeling that people experience when using marijuana comes from THC activating the CB1 receptors in the brain.

But when endocannabinoids activate CB1 receptors, by comparison, they do not cause a marijuana high. One reason is that the body produces them in smaller quantities than the typical amount of THC in marijuana. The other is that certain enzymes break them down rapidly after they carry out their cellular functions.

However, there is growing evidence that certain activities may release mood-elevating endocannabinoids. Some research suggests that the relaxed, euphoric feeling you get after exercise, called a “runner’s high,” results from the release of endocannabinoids rather than from endorphins, as previously thought.

The endocannabinoids regulate several bodily functions such as sleep, mood, appetite, learning, memory, body temperature, pain, immune functions and fertility. They control some of these functions by regulating nerve cell signaling in the brain. Normally, nerve cells communicate with one another at junctions called synapses. The endocannabinoid system in the brain regulates this communication at synapses, which explains its ability to affect a wide array of bodily functions.

Research in our laboratory has shown that certain cells of the immune system produce endocannabinoids that can regulate inflammation and other immune functions through the activation of CB2 receptors.

In addition, we have shown that endocannabinoids are highly effective in lessening the debilitating effects of autoimmune diseases. These are diseases in which the immune system goes haywire and starts destroying the body’s organs and tissues. Examples include multiple sclerosis, lupus, hepatitis and arthritis.

Chronic Pain Linked to Low Levels of Endocannabinoids

Recent research suggests that migraine, fibromyalgia, irritable bowel syndrome, post-traumatic stress disorder and bipolar disease are all linked to low levels of endocannabinoids.

In a 2022 study, researchers found that a defect in a gene that helps produce endocannabinoids causes early onset of Parkinson’s disease. Another 2022 study linked the same gene defect to other neurological disorders, including developmental delay, poor muscle control and vision problems.

Other research has shown that people with a defective form of CB1 receptors experience increased pain sensitivity such as migraine headaches and suffer from sleep and memory disorders and anxiety.

We believe that the medicinal properties of THC may be linked to the molecule’s ability to compensate for a deficiency or defect in the production or functions of the endocannabinoids.

For example, scientists have found that people who experience certain types of chronic pain may have decreased production of endocannabinoids. People who consume marijuana for medicinal purposes report significant relief from pain. Because the THC in marijuana is the cannabinoid that reduces pain, it may be helping to compensate for the decreased production or functions of endocannabinoids in such patients.

Deciphering the role of endocannabinoids is still an emerging area of health research. Certainly much more research is needed to decipher their role in regulating different functions in the body.

In our view, it will also be important to continue to unravel the relationship between defects in the endocannabinoid system and the development of various diseases and clinical disorders. We think that the answers could hold great promise for the development of new therapies using the body’s own cannabinoids.

Prakash Nagarkatti, PhD, and Mitzi Nagarkatti, PhD, are Professors of Pathology, Microbiology and Immunology at the University of South Carolina. They receive funding from the National Science Foundation and the National Institutes of Health.

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

FDA Approves Wearable Device for Migraine Prevention

By Pat Anson, PNN Editor

A wearable neuromodulation device has been approved by the Food and Drug Administration as a preventative treatment for migraine. In a recent study, the Nerivio device significantly reduced the number of migraine days per month in patients with episodic and chronic migraine.

Nerivio is worn on the upper arm and controlled by a smartphone app. It uses mild electrical pulses to disrupt pain signals in the brain without the use of drugs. The device has previously received clearance from the FDA as an acute treatment for migraine in adults and children over age 12.

"Nerivio already has a well-established efficacy and safety profile in acute migraine treatment," said Andrew Blumenfeld, MD, Director of the Los Angeles Headache Center and co-author of the study published in the journal Headache. "Effective preventive treatment is key to managing migraine, but it is often underutilized.”

THERANICA IMAGE

The randomized, placebo-controlled trial involved 248 migraine sufferers who used either Nerivio or a placebo device for 45 minutes every other day. Those who used Nerivio experienced a mean reduction of 4 migraine days per month, compared to a reduction of 1.3 days in the placebo group. Participants also experienced statistically significant reductions in the number of days they required acute migraine medication.

“The trial data demonstrates Nerivio can now cover the full treatment spectrum and provide access to migraine prevention and relief, especially for the adolescent population, who have a strong preference for clinically effective, drug-free treatment solutions. With FDA clearance of the device, its availability and potential use for preventive and acute treatment is welcome news for both physicians and patients," Blumenfeld said in a statement.

Like most new migraine treatments, Nerivio can be expensive, with the wholesale price currently listed at $599 for a 12-treatment unit. Out of pocket costs will be less if the device is covered by insurance or if patients enroll in Nerivio’s Patient Savings Program. A prescription is required.

With Nerivio’s new dual-use indication, patients may use the device more often to proactively prevent migraines. To better support existing and new users, the number of treatments per unit is being expanded from 12 to 18 treatments.

The Nerivio app allows patients to customize their treatment, receive reminders for preventive treatment, track their migraine patterns, and share migraine data with their doctor. The app can also leads users through a Guided Intervention of Education and Relaxation, using techniques such as diaphragmatic breathing, muscle relaxation and guided imagery.

Nerivio is made by Theranica, a medical technology company based in Israel, which estimates the device has over 40,000 users in the United States. The company is investigating whether the device may help treat other chronic pain conditions besides migraine.

Are You Suffering from Toxic Stress?

By Ann Marie Gaudon, PNN Columnist

There is no such thing as life without stress. It’s both a physiological and psychological response to a real threat or a perceived one. Stress tends to resolve itself naturally and in a timely way as the situation resolves, but “toxic stress” is different.

Frequent chronic stress, in the absence of adequate support, has harmful and potentially lasting effects on a person’s physical and mental health. It can affect anyone at any age, and no one is immune.

You are at risk for toxic stress when the stress is persistent and severe. You may have multiple stress factors and the body will react to them. One reaction will be that the body’s fight-or-flight, faint-or-freeze response is activated too often or for too long. This results in the release of stress hormones, one of which is cortisol. Long-term heightened levels of cortisol can become dysfunctional, inducing widespread inflammation and pain.

There is a very real biological link between stress, anxiety and pain. Toxic stress makes you more at risk for many types of chronic illness and pain, a dampened immune system, infections, mental health issues, poor emotional regulation skills, and even substance abuse. You can become sick and stay sick.

Toxic stress will also make you more vulnerable to chronic anxiety, which can include panic attacks. You may become hypersensitive to threat and to pain severity. Your behaviour will also likely change, which can mean trouble for relationships. In short, toxic stress will invade every thread of the fabric of your life.

Types of Stress

Center on the developing child, harvard university

Stress Buffers

Toxic stress can’t always be avoided – the loss of a beloved one, a nasty divorce, conflict in the home, chronic depression, feelings of betrayal and other life changes are sometimes inevitable.

However, a relationship with an adult who is loving, responsive and stable can help to buffer against the effects of stress and stop it from turning toxic. Other buffers include high levels of social support, consistent nurturing, and confidence in your problem-solving skills are just a few in an umbrella of many.

There are strategies you can do on your own to help buffer yourself against the consequences of toxic stress. Crucially, it is important to focus on what you can control, not what you have no control over. Toxic stress may include factors that are actually beyond your control, leaving you more distressed and overwhelmed, so it’s very important to become aware of the differences.

Write a list of what you can and cannot control. Take the reins on what you are able to, even if it’s as routine as what you’ll eat for dinner each day. Spend your time and energy on things that can improve your situation and can get a handle on. Remember, when we rail against that which we cannot control, that is when our suffering soars.

Healthy Living

Focus on a healthy lifestyle. Toxic stress can easily slide into unhealthy habits such as smoking, too much alcohol, overeating, overworking and the like. You may get temporary relief from them, but in the long-term these poor coping mechanisms will serve to worsen your stress. Eat well, exercise, get outside into nature, and try as best you can to get good sleep while practicing sleep hygiene.

Some people have a tendency to isolate themselves when stressed, yet one of the most protective buffers against toxic stress is support from people who care about you. Never underestimate the power of touch, including deliberate and welcome hugs. Reach out, engage with others, and make plans with others who are close to you. You want to be with adults who are soothing, safe and secure for you.

Find a relaxation technique that helps you lower your stress level. I’m a little different than some, because vigorous exercise is my happy place. Heart-pumping, blood-flowing, rushes of endorphins take my physical pain down and make me feel relaxed.

Alternatively, you might benefit from stillness with mindfulness practice, journalling, yoga or Tai Chi, body scans or progressive muscle relaxation techniques. Find your happy place and go there as often as you are able.

A very wise colleague of mine told me that we need three things to be happy: someone to love, a purpose, and something to look forward to. Go ahead and set goals, and plan for the future.

Toxic stress can have the sufferer believing that things will never improve, which leads to hopelessness and despair. Making plans for the future will give you some direction and purpose, as well as something to look forward to. When a good experience happens, optimism can drop by for a visit to remind you that life won’t always be so challenging.

As always, if you’re really struggling, reach out to a trained professional. We all need help at times in our lives, and one of those times might be when you’re dealing with toxic stress.  Your professional therapist will support you and help you with tools and strategies so that you can in turn support yourself.

Ann Marie Gaudon is a registered social worker and psychotherapist in the Waterloo region of Ontario, Canada with a specialty in chronic pain management.  She has been a chronic pain patient for over 30 years and works part-time as her health allows. For more information about Ann Marie's counseling services, visit her website. 

DEA to Reimpose ‘Guardrails’ on Telehealth Opioids

By Pat Anson, PNN Editor

The U.S. Drug Enforcement Administration plans to reimpose rules that require doctors to meet face-to-face with patients before they are prescribed opioids and other controlled substances.

The rules were suspended in 2020 in the early stages of the Covid-19 pandemic so that doctors and patients could connect remotely via telehealth – also known as telemedicine --  to get medications prescribed without an in-person meeting.

But when the federal government ends the Covid public health emergency on May 11, the DEA plans to restore “appropriate safeguards” on medications it considers addictive. Patients will still be able to get prescriptions for antibiotics, statins, insulin and other common medications through telehealth, without a physical examination or meeting with a doctor.

“DEA is committed to ensuring that all Americans can access needed medications,” said DEA Administrator Anne Milgram said in a statement.  “The permanent expansion of telemedicine flexibilities would continue greater access to care for patients across the country, while ensuring the safety of patients. DEA is committed to the expansion of telemedicine with guardrails that prevent the online overprescribing of controlled medications that can cause harm.”  

Under the DEA’s proposed rules, Schedule II controlled substances such as oxycodone and hydrocodone cannot be prescribed without first having an in-person meeting. Refills would then be allowed via telehealth.

Other drugs that are classified as Schedule III, IV or V substances – such as Xanax (alprazolam) and Suboxone (buprenorphine) could still be prescribed for 30 days via telehealth, but any refills will require an in-person meeting.

The DEA rules were developed in conjunction with the Department of Health and Human Services (HHS) and the Department of Veterans Affairs. Public comments on the rules can be submitted through the Federal Register by clicking here.

“Improved access to mental health and substance use disorder services through expanded telemedicine flexibilities will save lives,” said HHS Secretary Xavier Becerra. “We still have millions of Americans, particularly those living in rural communities, who face difficulties accessing a doctor or health care provider in-person.”

Drug overdoses rose sharply during the pandemic, with nearly 107,500 drug deaths reported in the 12-month period ending in August, 2022. About 70% of the fatal overdoses involved illicit fentanyl and other street drugs, not prescribed medications.