Can Psychotherapy Treat Chronic Back Pain?

By Pat Anson, PNN Editor

Anyone who has lived with chronic back pain knows how difficult it is to treat. Pain medications provide only temporary relief, and surgeries and injections can be risky.

An extensive review of back pain treatments by The Lancet concluded that many were of “dubious benefit” and that most people with low back pain would respond to “simple physical and psychological therapies” that keep them active.

A small study recently published in JAMA Psychiatry lends some support to that belief, finding that two-thirds of chronic back pain patients who received a novel psychological treatment called Pain Reprocessing Therapy (PRT) were pain-free or nearly pain-free after four weeks. Most continued to experience relief for a year.

The researchers behind the study liken chronic pain to an alarm clock stuck in the “on” position long after the initial injury has healed.

“For a long time we have thought that chronic pain is due primarily to problems in the body, and most treatments to date have targeted that,” said lead author Yoni Ashar, PhD, a postdoctoral associate at Weill Cornell Medical College. “This treatment is based on the premise that the brain can generate pain in the absence of injury or after an injury has healed, and that people can unlearn that pain. Our study shows it works.”

PRT therapy was developed by Alan Gordon, a Los Angeles-based psychotherapist and author of a new book on healing chronic pain called “The Way Out.”

PRT is based on the premise that patients can reduce or even eliminate chronic pain by changing the way they think about it, using mindfulness and cognitive behavioral therapy. The goal is to eliminate fear and avoidance techniques that many patients have about their pain.

“The idea is that by thinking about the pain as safe rather than threatening, patients can alter the brain networks reinforcing the pain, and neutralize it,” Ashar explained.

For the randomized controlled trial, Ashar and his colleagues recruited 151 people who had low to moderate back pain for at least six months, with an intensity of at least four on a pain scale of zero to 10.

Those in the treatment group received 8 one-hour sessions of PRT, in which they were encouraged to reappraise the severity of their pain by engaging in movements they were afraid to do. This helped them overcome some of the negative emotions they had about pain. 

After four weeks, 66 percent of patients in the treatment group were pain-free or nearly pain-free, compared to 20% in a placebo group and 10% who received no treatment.

The findings were confirmed post-treatment by MRI brain scans, which showed that brain regions associated with pain processing – such as the anterior insula and anterior midcingulate — had quieted significantly in those who had PRT therapy. 

“The magnitude and durability of pain reductions we saw are very rarely observed in chronic pain treatment trials,” Ashar said.

The study focused only on PRT therapy for back pain, so future studies are needed to determine if PRT would produce similar results for other types of chronic pain. 

“This study suggests a fundamentally new way to think about both the causes of chronic back pain for many people and the tools that are available to treat that pain,” said co-author Sona Dimidjian, PhD, a professor of psychology and neuroscience at CU Boulder. “It provides a potentially powerful option for people who want to live free or nearly free of pain.”

Study Identifies Medications Most Involved in ER Visits

By Pat Anson, PNN Editor

Here’s a question for you: What type of medication is most likely to be involved in a visit to a hospital emergency room?

1. Opioid pain relievers

2. Blood thinners

3. Psychiatric drugs

4. Insulin

5. Antibiotics

Given the well-publicized risks of addiction and overdose associated with opioids, you might assume it was opioid pain relievers. You’d also be wrong, according to a large new study that looked at medications associated with emergency department (ED) visits in the U.S. from 2017 to 2019.

CDC researchers looked at a representative sample of nearly 97,000 cases of adverse events involving medication and found that warfarin (Coumadin) and other anti-coagulant blood thinners – typically prescribed to reduce the risk of heart attack and stroke -- were the leading cause of ED visits.

Among patients of all ages, insulin was the second leading cause of medication-related adverse events, followed by psychiatric drugs, antibiotics and the over-the-counter pain relievers ibuprofen and acetaminophen. The opioid oxycodone came in last on a Top 10 list of drugs involved in ED visits.

TOP 10 MEDICATIONS INVOLVED IN EMERGENCY DEPARTMENT VISITS

SOURCE: CDC

The study findings, published in JAMA, help dispel many of the myths associated with the risks of opioids — at least in comparison to other widely used medications.

There are many reasons for someone to have an adverse reaction to medication, ranging from allergies to dosage errors to taking drugs intended for someone else. About a third of the ED visits were so serious, the patient was admitted for hospitalization.

Compared to seniors age 65 and older, young adults were significantly more likely to abuse a medication or to use it for intentional self-harm. Seniors were far more likely to only take a drug for its intended therapeutics use.

SOURCE: jama

The age of a patient also plays a significant role in the type of drug they have an adverse reaction to. For example, the antibiotic amoxicillin was the leading cause of medication harm for patients under the age of 14; while the anti-anxiety drug alprazolam (Xanax) was the leading cause of adverse events for patients aged 15 to 44.  Insulin ranked first for patients aged 45-64; while warfarin was first for patients aged 65 and older.

Analgesics, sedatives and antidepressants were the drugs most likely to be abused. About 63% of adverse events involving prescription opioids were cases of “non-therapeutic” abuse, while 89% of cases involving benzodiazepines were classified as abuse. The vast majority of cases involving blood thinners, insulin or antibiotics were for their intended therapeutic use.    

The role of opioids in ED visits has been falling for over a decade. A 2017 study showed a significant decline in the number of patients admitted to U.S. hospitals for abusing opioid medication. Hospital admissions for overdoses from opioid medication started falling in 2010, the same year that opioid prescriptions peaked in the U.S.

Surprise Discovery Could Lead to Vaccine for Rheumatoid Arthritis

By Pat Anson, Editor

A surprise discovery at a university laboratory could lead to a vaccine that can prevent rheumatoid arthritis, a chronic and incurable disease in which the body’s own immune system attacks joint tissues.

Researchers at The University of Toledo years were studying a protein called 14-3-3 zeta and its role in immune system pathologies. Previous studies have suggested the protein could be a possible trigger for rheumatoid arthritis (RA) and other autoimmune conditions that cause pain, inflammation and bone erosion.

But researchers found just the opposite. The team discovered that 14-3-3 zeta proteins may actually help prevent arthritis. When they removed the proteins through gene-editing technology, it caused severe early onset arthritis in laboratory animals.

Realizing that the proteins may be beneficial, the team developed an experimental vaccine using purified 14-3-3 zeta protein grown in a bacterial cell. They found the vaccine promoted a strong, immediate and long-lasting response in rodents that protected them from RA.

"Much to our happy surprise, the rheumatoid arthritis totally disappeared in animals that received a vaccine," said Ritu Chakravarti, PhD, an assistant professor at UToledo College of Medicine and lead author of research published in the journal Proceedings of the National Academy of Sciences. "Sometimes there is no better way than serendipity. We happened to hit a wrong result, but it turned out to be the best result. Those kinds of scientific discoveries are very important in this field."

In addition to suppressing the immune system response, the vaccine also significantly improved collagen content and bone quality — findings that suggests there could be long-term benefits following immunization.

Currently, rheumatoid arthritis is treated with steroids or medications that suppress the immune system, such as biologics and biosimilar drugs. While those therapies can alleviate pain and reduce inflammation, they can also make patients more vulnerable to infection and, in the case of biologics, are expensive. Biologic drugs can cost $25,000 a year.

“We have not made any really big discoveries toward treating or preventing rheumatoid arthritis in many years,” Chakravarti said. “Our approach is completely different. This is a vaccine-based strategy based on a novel target that we hope can treat or prevent rheumatoid arthritis. The potential here is huge.”

RA affects about 1.5 million Americans and about one percent of the global population. Women experience RA at a rate three times greater than men, have more severe symptoms and increased disability.

“In spite of its high prevalence, there is no cure and we don’t entirely know what brings it on. This is true of nearly all autoimmune diseases, which makes treating or preventing them so difficult,” said Chakravarti. “If we can successfully get this vaccine into the clinic, it would be revolutionary.”

Chakravarti and her colleagues have filed for a patent on their discovery and are seeking pharmaceutical industry partners to fund more research and preclinical trials.

FDA Approves Another Expensive Migraine Drug

By Pat Anson, PNN Editor

The highly competitive and lucrative market for migraine drugs will grow more crowded this month when AbbVie introduces Qulipta (atogepant), an oral CGRP medication developed for the prevention of episodic migraines.

The Food and Drug Administration approved Qulipta after seeing the results of a Phase 3 clinical trial that found the drug was 50 to 100% effective in preventing migraines.

"During the trial while taking Qulipta, I had many fewer migraine days. For the first time ever, I don't have difficulty doing my daily activities and I don't have to worry as much that a migraine attack will cause me to miss important events with family and friends," said Kelsi Owens, a trial participant who has lived with migraine for nearly three decades.

Like other CGRP inhibitors, Qulipta blocks proteins called calcitonin gene-related peptides from binding to nerve receptors in the brain and causing migraine pain. Since 2018, the FDA has approved over half a dozen CGRP medications, most of which are injected monthly.

Qulipta is a pill meant to be taken daily that comes in three different doses. Like other CGRP inhibitors, Qulipta is expensive. The wholesale price for a patient without insurance is $991 for 30 pills, according to Abbvie. Insured patients or those enrolled in an AbbVie patient support program will pay less.     

"Qulipta provides a simple oral treatment option specifically developed to prevent migraine attacks and target CGRP, which is believed to be crucially involved in migraine in many patients," said study investigator Peter Goadsby, MD, a neurologist and professor at University of California, Los Angeles. “I'm particularly encouraged by the convenience of the oral daily use of Qulipta, its rapid onset of significant efficacy, and its safety and tolerability as well as its high patient response rates.”   

Qulipta is expected to compete directly with Nurtec, an oral CGRP inhibitor made by Biohaven Pharmaceuticals that is approved for both migraine prevention and treatment. A supply of eight Nurtec tablets costs about $941, depending on insurance coverage. Since it was introduced in 2020, Nurtec has generated about $200 million in revenue for Biohaven, with over 750,000 prescriptions filled.

AbbVie says Qulipta will be available in early October. Wall Street analysts project Qulipta sales will reach $1 billion by 2030.

Side effects from Qulipta include nausea, constipation, fatigue and loss of appetite. AbbVie is currently conducting a clinical trial to seek if Qulipta should also be approved for the prevention of chronic migraine – patients who have 15 or more headaches per month.

Migraine affects more than 37 million people in the United States, according to the American Migraine Foundation. In addition to headache pain, migraine can cause nausea, visual disturbances, and sensitivity to light and sound. Women are three times more likely to suffer from migraines than men.

What Pain Patients Should Know About the GABA Neurotransmitter

By Forest Tennant, PNN Columnist

“GABA” is short for the neurotransmitter, gamma aminobutyric acid. GABA is the natural (endogenous) biochemical substance in the brain, spinal cord, and all nerves that control electrical conduction.

Without proper GABA function, we experience pain. New research also shows that low levels of GABA make it harder to keep negative emotions such as fear, worry, anxiety and depression in check. 

All Intractable Pain Syndrome (IPS) patients have nerve damage somewhere in their brain, spinal cord, or nerves. Consequently, IPS patients will either need extra GABA or a GABA surrogate to force damaged nerve tissue to correctly function and relieve pain. 

GABA Surrogates

Without realizing it, you may already be taking a GABA surrogate. And you may have found that your pain gets worse without one. Here are the most effective prescription surrogates:

• Gabapentin (Neurontin)

• Carisoprodol (Soma)

• Diazepam (Valium)

• Alprazolam (Xanax)

• Lorazepam (Ativan)

There are also herbs and amino acids available without a prescription that can be used as GABA surrogates:

• Valerian root

• Ashwagandha

• Taurine

• Brahmi

• Bacopa

Glutamine: GABA’s Precursor

The term “precursor” refers to nutrients or raw material that help make a neurotransmitter. Glutamine is the precursor of GABA. A dose of 2000 mg or more of glutamine a day when taken on an empty stomach with vitamin B6 (2mg or more), will increase your natural level of GABA and probably reduce your pain levels. 

Pure GABA is available as a tablet, capsule or in sublingual (under-the tongue) form in most health food stores or online. Unfortunately, when swallowed in tablet or capsule form, GABA may be digested just like food or fail to cross the blood-brain barrier, and be rendered ineffective.

But sublingual GABA is well absorbed by the body and should be given a thorough trial by every person with IPS. You can take 100 to 300mg sublingual GABA to treat pain flares, or 100 to 200mg of GABA simultaneously with an opioid medication or GABA surrogate for added pain relief.

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

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

Why Pain Is Not ‘All in Your Head’

By Gabriella Kelly-Davies, PNN Columnist

Anyone who lives with chronic pain knows it can affect their emotions. Every morning when I wake with a migraine, I feel a sense of doom. My heart races and I panic about how I will cope with everything that lies ahead of me that day — the meetings, deadlines and responsibilities, not to mention family and social commitments that often end up taking a back seat as I scramble to find ways of simplifying my day.

After decades of living with chronic migraine, I now know these emotions intensify my experience of pain. Having said this, I know it is not “all in my head” as some might claim, but part of a complex interaction between my emotions and the way my central nervous system incorrectly processes pain signals.

Exciting new Australian research using sophisticated brain imaging is shedding new light on what happens at an emotional level for people living with chronic pain.

Chemical “messengers” known as neurotransmitters facilitate communication between brain cells. Some neurotransmitters are inhibitory, helping to dial down our emotions, while others are excitatory and increase the intensity of emotions. A molecule known as γ-aminobutyric acid or GABA is the main inhibitory neurotransmitter.

Neuroscientist and psychologist Sylvia Gustin, PhD, discovered that GABA levels are lower in people with chronic pain and this affects their ability to regulate their emotions. The link between lower levels of GABA and chronic pain had been shown in animal studies, but Gustin’s research, recently published in the European Journal of Pain, is the first time it has been demonstrated in humans.

“A decrease in GABA means our brain cells can no longer communicate with each other properly,” explained Gustin, an associate professor at the University of Sydney’s School of Psychology. “When there’s a decrease in GABA, it makes it harder to keep emotions such as fear, worry, anxiety and depression in check.”

Gustin’s research shows there’s a physical change in the central nervous system that helps explain the roller coaster of emotions people living with pain often experience.

“If you live with chronic pain, it’s important to remember it’s not you -- there’s something physically happening to your brain. We don’t yet know why this happens, but we’re working on finding solutions on how to change it,” Gustin told me.

Her research confirms that chronic pain, which affects one in five people worldwide, is more than just an uncomfortable sensation. “It can affect our feelings, beliefs and the way we are,” she says. “Almost half the people living with chronic pain also experience major anxiety and depression disorders.”

GABA is not the only neurotransmitter that behaves differently in people living with chronic pain. In an earlier study, Gustin and her colleagues found levels of the main excitatory neurotransmitter in the central nervous system – glutamate -- are also lower in people with chronic pain. Lower glutamate levels are linked to increased feelings of fear, worry and negative thinking. They disrupt how brain cells talk to each other, affecting the ability to feel positive emotions such as happiness, motivation and confidence.

“My research results are reassuring for people living with pain because they show that physical changes in the brain are contributing to anxiety and depression and it’s not a person’s fault they struggle with these emotions,” Gustin said.

Her research team recently developed and tested an online recovery program that teaches people skills to help modify negative emotions such as fear, worry, anxiety and depression. The program helps to address the neurotransmitter disruption in chronic pain.

“Online programs offer hope to people living with disabilities or those in rural and remote communities who often struggle to access pain management services,” she said. “Online programs are also ideal during COVID-19 lockdowns.

“We know that chronic pain is always present, and we can’t get rid of it. But we can change the way we experience it by learning new skills. Like all skills, it takes practice to master it, but we hope it will offer another tool for people to change the way they experience pain.”

Gustin says preliminary results of this research, which will be published in a few months, are encouraging. Several organizations, including Australia’s National Health and Medical Research Council and Medical Research Future Fund, the International Association for the Study of Pain (IASP) and the U.S. Department of Defense, are helping to fund her work. To learn more about this research, click here.

Gabriella Kelly-Davies lives with chronic migraine.  She is the author of “Breaking Through the Pain Barrier,” a biography of trailblazing Australian pain specialist Dr. Michael Cousins. Gabriella is President of Life Stories Australia Association and founder of Share your life story.

Holistic Therapy Won’t Cure You, But It Can Help

By Mia Maysack, PNN Columnist 

To mark the end of Pain Awareness Month,  I'd like to share a few holistic therapies that have proven helpful on my journey. 

I’m not suggesting they are magic remedies or that they're the right choices for everyone. Many of us who live with chronic or intractable pain have our minds closed off to new things. And after all we've been through, who could blame us?   

There is an endless amount of misinformation and misinterpretation regarding holistic and preventative medicine, and no shortage of judgement. I'll be honest by confessing that I have also been a skeptic to some extent about holistic therapy, but it has ultimately helped me more than two decades of “mainstream" traditional medicine.  

I'd like to think I have established credibility as it pertains to my own personal experiences, just as I honor anyone else's. Here is what I have learned about holistic therapy:   

Having an open mind and willingness to expand consciousness about the limitations that pain imposes on our lives -- and taking leadership in our own journey – means coping, managing, adapting, transcending and evolving as best we can.  

These therapies don't really work until WE WORK ‘EM and add them to a tool box full of different things to pull from.  Allow yourself the curiosity of what could be possible if you were to try something new. If there are still doubts or if you tried and failed with them in the past, then ask yourself: When’s the last time anything went perfectly right the first time?   

We cannot know unless we try. To have found anything that's assisted, helped or if you're lucky enough to have something that actually works would not be possible without an attempt to try it in the first place.  

The great thing I have found about these holistic therapies is that they have positive side effects, are healthy and habit forming.  

Soaking in Warm Water:  I use generous amounts of Epsom salt (magnesium sulfate) in a bathtub. It creates a soothing buoyancy that makes the body seem weightless.  

Massage Therapy:  Manipulation of soft tissues of the body, consisting primarily of manual techniques, such as applying fixed or movable pressure, holding, and moving muscles and body tissues. 

Mindfulness:  A mental state achieved by focusing one's awareness on the present moment, while calmly acknowledging and accepting one's feelings, thoughts, and bodily sensations. 

Energy Healing:  Also known as Reiki or Qigong, energy healing offers the potential for a positive shift in physiological state and present moment awareness that may alter the perspectives that sustain the burden of symptoms. 

Yoga:  A mind and body practice. Various styles of yoga combine physical postures, breathing techniques, and meditation or relaxation to promote mental and physical well-being. There are several types and many different disciplines. 

None of these are meant to replace any existing care plan, but rather contribute to a well-rounded approach to our whole being and health. Imagine committing the same amount of energy spent fighting against these concepts into exploring ways to incorporate them into your life. You just might find that they help.          

Mia Maysack lives with traumatic brain injury, migraine disease, cluster headache and fibromyalgia. Mia 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. 

Mia was recently chosen as a recipient of the 2021 iPain Community Impact Award for her advocacy work.

DEA Warns of Sharp Increase in Counterfeit Prescription Pills

By Pat Anson, PNN Editor

The U.S. Drug Enforcement Administration has issued a public safety alert warning of a sharp increase in the black market of fake painkillers and other counterfeit medications containing illicit fentanyl and methamphetamine. The alert, the DEA’s first in six years, coincides with the launch of a public awareness campaign to educate the public about the dangers of counterfeit pills.

“The United States is facing an unprecedented crisis of overdose deaths fueled by illegally manufactured fentanyl and methamphetamine,” DEA Administrator Anne Milgram said in a statement. “Counterfeit pills that contain these dangerous and extremely addictive drugs are more lethal and more accessible than ever before. In fact, DEA lab analyses reveal that two out of every five fake pills with fentanyl contain a potentially lethal dose.

It takes only two milligrams of fentanyl – an amount small enough to fit on the tip of a pencil – to constitute a lethal dose. The DEA says it has seized over 9.5 million fake pills so far this year, which is more than the last two years combined.

A recent raid on a home in Perris, California resulted in the seizure of 46 pounds of carafentanil,  – a chemical cousin of fentanyl – which is potentially enough to kill more than 50 million people, according to the Riverside County District Attorney.

Carfentanil is a synthethic opioid 100 times more potent than fentanyl and 10,000 times more potent than morphine.

FAKE OXYCODONE PILLS

The DEA says most of the counterfeit pills manufactured or smuggled into the U.S are produced by Mexican drug cartels, using illicit chemicals that originate in China.

One of the most commonly produced fake pills are tablets made to look like 30mg oxycodone pills. Known on the street as “Mexican Oxy” or “M30s,” the tablets are virtually indistinguishable from legitimate oxycodone pills used for pain relief.   

Law enforcement agencies are also finding counterfeit anti-anxiety medications made to look like Xanax and fake pills that look like the stimulant Adderall, which are made with methamphetamine.  

‘One Pill Can Kill’

The goal of the DEA’s “One Pill Can Kill” campaign is to make the public more aware of the proliferation of counterfeit medications — now found in every state — and to warn drug users not trust any pill that doesn’t come from a pharmacist.  

“Counterfeit pills have become a real and viable threat to the American People,” said Daniel Comeaux, Special Agent in Charge of the DEA’s Houston Division.  “We caution every person to never consume any pill that is not sourced from a licensed pharmacy. These illicit counterfeit pills often contain fentanyl, where just a miniscule amount can result in death.”

Ironically, the DEA itself has played a significant role in the profusion of fake pills and its PR campaign is little more than a fig leaf covering years of disastrous policies.

Counterfeit medication made with illicit fentanyl first began appearing in quantity in the U.S. in 2016, around the same time federal and state regulators began recommending more cautious opioid prescribing for pain.

Faced with pressure from Congress to combat the so-called opioid epidemic by cracking down on painkillers, the DEA began cutting the legal supply of opioids in 2017. It has reduced opioid production quotas for five consecutive years, cutting the legal supply of hydrocodone and oxycodone in half.

The agency also began arresting and prosecuting doctors and pharmacists thought to be prescribing or dispensing opioids excessively, and revoked the DEA registrations of hundreds of physicians. As a result, opioid prescribing fell to 20-year lows, but the crackdown has had a negligible impact on drug overdoses, which rose to record levels.

With opioid medication harder to obtain, illegal online pharmacies began to proliferate and legitimate patients turned to street drugs for relief. A recent PNN survey of pain patients found that nearly 10% have obtained prescription opioids from family, friends or the black market.

In a 2020 report, the DEA said drug cartels were actively targeting pain sufferers as potential customers for counterfeit medication.  The report said nearly two-thirds (64%) of people who misuse painkillers “identified relieving pain as the main purpose” of their drug use.

Researchers Urge Caution on Using Steroid Injections for Pain

By Pat Anson, PNN Editor

Doctors and patients should be more cautious about using corticosteroid injections for pain relief, according to new studies that warn of rare, but serious long-term complications for patients who receive epidurals during childbirth or high doses and multiple injections in their hips.

Researchers at Kaiser Moanalua Medical Center in Hawaii looked at health data for nearly 700 patients with hip osteoarthritis and found that those who received steroid injections were 8.5 times more likely to develop rapidly destructive hip disease (RDHD), a condition that causes the loss of blood flow and death of bone tissue in the hip.

Higher rates of RDHD were especially apparent in patients receiving multiple and/or high-dose injections of the steroid triamcinolone. The risk of RDHD following a single, low-dose injection was about two percent, but rose to five percent following multiple low-dose injections or a single high-dose injection, and up to 10 percent following multiple high-dose injections.

“While the risk of RDHD following a single low-dose (40 mg or less) triamcinolone injection is low, the risk is higher following high-dose (80 mg or more) injection and multiple injections. These findings provide information that can be used to counsel patients about the risks associated with this common procedure. In addition, caution should be taken with intra-articular hip injections utilizing 80 mg of corticosteroid and multiple injections,” wrote lead author Kanu Okike, MD, of Hawaii Permanente Medical Group in Honolulu.

As they became more aware of a possible link with RDHD, orthopedic surgeons at the hospital started ordering fewer hip corticosteroid injections. In subsequent years, the number of RDHD cases decreased. The hospital also added a discussion of post-injection RDHD to the informed consent process for patients and stopped performing high-dose corticosteroid injections.

The study, recently published in The Journal of Bone & Joint Surgery, is believed to be the largest to date of patients with post-injection RDHD.

Epidural Injections

Two new studies have also found that women receiving epidural injections for pain relief during labor are at high risk of long-term headaches and chronic back pain if the needle accidentally punctures the dural lining of the spinal cord. Dural punctures or “wet taps” cause the leak of spinal fluid, which can result in serious neurological complications.  

“I’ve likely performed more than 10,000 epidurals in my lifetime, and I still have wet taps from time to time,” Pamela Flood, MD, a professor of anesthesiology at Stanford University School of Medicine, told Anesthesiology News. “But no matter how many we’ve seen, we still feel terrible about each one. We’re trying to relieve people’s pain and give them a wonderful childbirth experience, and the last thing we want to do is cause them complications.”

A study published in the journal Anaesthesia found that over half of women (58%) with an accidental dural puncture were still experiencing headaches 18 months after the epidural, and nearly half (48%) suffered from chronic low back pain. A recent study in the British Journal of Anaesthesia had similar findings.    

Dural punctures during epidurals are relatively uncommon. Women are usually warned there is a risk of short-term headaches, but not about long-term health problems.

“While this information has been creeping into our consciousness in the form of retrospective trials, only this year has it been confirmed with two large prospective trials,” Flood said. “Unfortunately, clinicians have been slow to hear this, perhaps because we don’t want to admit that the short-term concern that we have been discussing for years carries long-term consequences in a significant percentage of women.”

The two most common types of medications used during epidural injections are anesthetics (lidocaine or bupivacaine) or corticosteroids (betamethasone, dexamethasone, hydrocortisone, methyl-prednisolone, triamcinolone). 

In addition to treating labor pain, epidural steroid injections are widely used for back pain. About 9 million epidural steroid injections are performed annually in the U.S., even though they are not FDA-approved. The FDA has warned that injection of steroids into the epidural space can result in rare but serious neurological problems, including loss of vision, stroke and paralysis. Some patients have also developed arachnoiditis, a chronic and painful inflammation of the spinal cord, after getting steroid injections for back pain.

Epidemiological Sleuthing During the Pandemic

By Roger Chriss, PNN Columnist

How do we figure out what is really going on with Covid-19? Amid the ongoing surge of Covid cases from the delta variant of SARS-CoV-2, this is very important.

As hospitals are overwhelmed with patients, beds are unavailable, supplies of monoclonal antibody drugs are limited, and frontline healthcare workers are strained. Understanding what is really happening becomes vital to an effective response.

One of the tools most widely used to track the severity of the pandemic is the number of patients that are hospitalized. According to the CDC, we’re currently seeing an average of 9,636 new admissions every day, which is about 14% less than a week ago.   

New Hospital Admissions for Covid-19

But how reliable are these numbers? And just how sick are the patients?

A recent preprint study of VA patients before the delta surge suggested that almost half of hospitalized Covid-19 cases had mild or asymptomatic symptoms. This finding prompted The Atlantic to conclude that the significance of the hospitalization gauge “can easily be misinterpreted.”

As often happens with public health data in the US, information is missing. SFGate recently investigated Covid-19 hospitalizations in the Bay Area and found that simply tracking patient numbers was unreliable. Three major hospital systems -- San Francisco General, Kaiser Permanente and Sutter Health -- could not say if mild and asymptomatic cases made up a large proportion of their Covid patients.

In other words, in many cases hospitals simply don’t have the data needed to assess the severity of outbreaks. We need better ways to validate hospitalization counts and assess local conditions in near real time.  

Fortunately, we have them. Broadly speaking, these include community surveillance, hospital monitoring and indirect signals. Each of these comprises multiple sources of information, and when combined, the result is a deep assessment of Covid conditions.

Carnegie Mellon University’s COVIDCast gives early indicators, including doctor’s visits and symptoms in communities across the nation. This can be paired with public behaviors like masking and distancing, visits to bars or restaurants, local vaccination rates, and searches on Google for Covid symptoms. All of this helps build a risk profile for a community that can be confirmatory for hospitalization data.

Similarly, wastewater epidemiology provides a close look at something all communities produce. For instance, the Sewershed Surveillance Project in Missouri has tracked virus levels in effluent for a year, with spikes often warning of possible outbreaks in cities and counties throughout the state. Wastewater epidemiology is already used in Europe and many parts of the US to help track drug use and disease activity.  

Next comes personnel. Hospital staff is in constant flux, and job postings provide valuable clues about what hospitals are expecting or confronting. For instance, travel nurses move around the US in response to calls for supplementary staff, so job boards like TravelNurse Source offer valuable insight for assessing a hospital’s needs.

The same for respiratory therapists, imaging technicians, and other frontline healthcare workers. Hospitals know their everyday needs, which can be readily found in reports from the American Hospital Association’s Data & Insights database. These reports include the number of staffed beds, admissions, and outpatient visits for most hospitals in the US. If we know what hospitals typically have and see, that allows us to check if they are experiencing a Covid surge.

Further, we have drug and equipment orders. Hospitals have to track all orders for financial and regulatory reasons. So new orders for fentanyl to sedate patients who need intubation, requests for ECMO respiratory machines, or just reordering PPE equipment and other supplies are all readily monitored via federal and state databases.

There are also indirect signals. Hospitals redirecting patients to other facilities, requesting ambulance or helicopter transport, arranging for at-home care for patients they might otherwise admit, or activating emergency plans are all publicly visible, as are signals such as requests for mobile morgues or National Guard assistance.

The above information can be combined to create a reasonably accurate profile of a hospital’s situation. Better, however, is to use such information proactively in order to avoid the severe surges seen in the South over the summer or in Idaho and Montana at present.

Early attempts to use wastewater epidemiology proactively have met with some success. When a wastewater sample from a dorm at the University of Arizona came back positive last year, the school quickly tested all 311 people who live and work there and found two asymptomatic students who tested positive.

All of the above is not limited to the pandemic. The same approach could be used for other infectious diseases, drug overdoses and other areas of public health. If the data streams and information analysis are combined and coordinated, the results could be that much better and more useful.

We cannot and should not rely on a single number, not with so many other tools available to be used. Hopefully we’ll see these tools put to use fast.

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

Rare Disease Spotlight: Sarcoidosis

By Barby Ingle, PNN Columnist

This month’s rare disease spotlight is on sarcoidosis. I have many friends living with this complex, autoimmune disorder, which affects about 200,000 Americans.

One of the first visible signs of sarcoidosis is for red bumps and patches called granulomas to form on the skin. Granulomas can also develop in the lungs, lymph glands and other internal organs, causing shortness of breath, abnormal heart rhythm, swollen glands and painful joints. The symptoms often appear suddenly and vary from person to person, depending on which organs are affected.

Although the symptoms usually go away on their own after a few months, the patients I know have lived with sarcoidosis long term. Some are less affected than others, but most people living with chronic sarcoidosis have major changes in every aspect of their body and life activities.

I think it is best to spotlight some of the people in my life who live with sarcoidosis on a daily basis. Frank Rivera and Kerry Wong have a website called Stronger Than Sarcoidosis. Karen Duffy shared her journey with sarcoidosis in one of my favorite books, "Backbone: Living with Chronic Pain without Turning into One."

You’ll see by reading their responses that sarcoidosis is tough to have, but they are tough, too.

How long have you lived with sarcoidosis?

Wong: “I was diagnosed in 2015, but that was after an 8-year search for answers … so I would say probably closer to 14 years.”

Duffy: “I have been living with sarcoidosis for 23 years! It took about 2 years to get a diagnosis of exclusion.”

Rivera: “I have been living with sarcoidosis since 2004, 17 years, but fully diagnosed in 2011. So, 10 years since diagnosis.”  

In what ways has living with sarcoidosis affected your life?

Duffy: “Sarcoidosis has impacted my life in countless ways. I live with neuro-sarcoidosis and I have severe pain issues. I also have Complex Regional Pain Syndrome. I find that the principles of stoic philosophy have really helped me accept that I cannot control what happens, I can only control how I respond.”

Rivera: “I am on disability now due to the bone and joint involvement and the pain I live with is a 6-7 pain level on a pain scale of 1-10, daily.”

Wong: “Oh, so many ways! Because the symptoms can be both severe and so unpredictable, I’m no longer able to work, and have been on disability since 2014. I’ve had to cancel plans with friends and family more times than I can count. And I’ve had to depend on my husband for so much more, for even the little things. But I’m so grateful for how he has stepped up as an incredible caregiver.

And that’s not to mention the emotional toll of the physical manifestations, the anxiety and depression that come from living with chronic pain, fatigue, and disability.”

Have you found anything that was helpful for the symptoms of sarcoidosis?

Duffy: “I believe in the power of the placebo. In Latin, placebo means "I Shall Please." I try to be useful, so I keep up with my volunteer projects. I find reading to help when I am roped to my sofa like Gulliver. On days when I am released from the grip of chronic pain, I love to walk. I follow my doctors’ advice and take my prescription meds.

I have found a pain cream called Tribe Revive---and it works for me! I no longer wear a pain patch, I just rub this CBD infused cream and the relief is instant. I have no connection to the company that makes the pain cream, I am just a very grateful customer. I buy so much of it and give out jars.”

Rivera: “Prednisone helped some, but the side effects almost killed me. Gave me a hole in my colon and diabetes as well as brittle bones.”

Wong: “Yes, thank goodness! Even after all this time, we are still working on finding the right treatment combination to help with my symptoms, but there are a few things that have helped. IVIG (Intravenous Immunoglobulin) therapy; heat and cold therapy; TENS (transcutaneous electric nerve stimulation); eTNS (electric trigeminal nerve stimulator); acupuncture and acupressure; and medical marijuana in a variety of forms.

Aside from that, probably the most helpful thing is learning to listen to my body. When it says I have to rest, I have to rest. Pushing myself to do more, which is what I have always done before, will only make me suffer that much more and that much longer afterward.”

Do you think there is a societal stigma on people living with sarcoidosis and other rare diseases?

Duffy: “I find that living with a chronic, invisible illness has its challenges. The pain from the nerve damage is cataclysmic, and it can be confusing that some days I can walk my dog, go for walks, and socialize with friends. Then other days, I am wiped out and live a smaller, quieter life. On these days, I read and write.”

Wong: “I am not sure if stigma is the word I would use, but there is definitely an additional problem for us. Because most people have never heard of sarcoidosis, they find it hard to understand and try to compare it to things they know. How often do we hear, ‘At least it’s not cancer?’  And because most of our symptoms are invisible, they find it hard to believe what they don’t see. That lack of understanding can have a tremendous impact on both personal and professional relationships.”

Rivera: “Yes, because from the outside we look fine. It is called an invisible illness because it works from the inside out.”

Is there anything you wish the world knew about sarcoidosis?

Wong: “Honestly, the thing I would love for people to understand most is how unpredictable the disease can be. Our symptoms can vary from day to day or hour to hour. That means what we are able to do varies as well. We always see inspirational examples of people who ‘didn’t let xyz stop them,’ but that is just not how it works with an incurable rare disease.

I always strive to do as much as I can to help others, but some days, the symptoms do win. That is not a character flaw or weakness; it is just the fact of the disease. Once those symptoms ease up and I am able to do more, I will always bounce back with purpose.”

Duffy: “I know it can be overwhelming to live with a rare, complicated, multisystem disorder. I have a serious illness, but I do not take it too seriously. Having a painful diagnosis and having a great life is possible. I am grateful for every day.”

Rivera: “Sarcoidosis is when a person's white blood cells become over active from an environmental accelerant. And instead of fighting off colds or foreign substance in the body, they clump together and form masses anywhere in the body as well as skin. This disease is a very painful disease and attacks the physical and mental health of a person.

With sarcoidosis, no two patients are alike. They call it the snowflake disease because no two patients are the same. That makes it very difficult to diagnose as well as treat because each temporary medicine does not work the same for each patient as well. So trying to help a sarcoidosis patient is very tough.”

Getting Help

If you need help with sarcoidosis, you should set up appointments with specialists to add to your treating team. These professionals would include a primary care provider, rheumatologist, pulmonologist, ophthalmologist and dermatologist.

Steroids are usually used to treat sarcoidosis. They reduce inflammation, and can stimulate tissue growth and repair. If steroids don’t work, immunosuppressant medications might be tried to reduce the immune system response. Pain medications may also be prescribed.  

Although the cause of sarcoidosis is unknown, the most widely known theory is it may be due to an immune reaction to a trigger, such as an infection or chemicals in those who are genetically predisposed. I look forward to the day that better testing and treatments exist for this rare disease.

Barby Ingle lives with reflex sympathetic dystrophy (RSD), migralepsy and endometriosis. Barby is a chronic pain educator, patient advocate, and president of the International Pain Foundation. She is also a motivational speaker and best-selling author on pain topics. More information about Barby can be found at her website.

Biosimilar Drugs Are Cheaper Than Biologics, But Are They as Effective?

By Michelle Andrews, Kaiser Health News  

It took years for Elle Moxley to get a diagnosis that explained her crippling gastrointestinal pain, digestion problems, fatigue, and hot, red rashes. And after learning in 2016 that she had Crohn’s disease, a chronic inflammation of the digestive tract, she spent more than four years trying medications before getting her disease under control with a biologic drug called Remicade.

So Moxley, 33, was dismayed to receive a notice from her insurer in January that Remicade would no longer be covered as a preferred drug on her plan. Another drug, Inflectra, which the Food and Drug Administration says has no meaningful clinical differences from Remicade, is now preferred. It is a “biosimilar” drug.

“I felt very powerless,” said Moxley, who recently started a job as a public relations coordinator for Kansas City Public Schools in Missouri. “I have this decision being made for me and my doctor that’s not in my best interest, and it might knock me out of remission.”

After Moxley’s first Inflectra infusion in July, she developed a painful rash. It went away after a few days, but she said she continues to feel extremely fatigued and experiences gastrointestinal pain, constipation, diarrhea and nausea.

Many medical professionals look to biosimilar drugs as a way to increase competition and give consumers cheaper options, much as generic drugs do, and they point to the more robust use of these products in Europe to cut costs.

ELLE MOXLEY

Yet the U.S. has been slower to adopt biosimilar drugs since the first such medicine was approved in 2015. That’s partly because of concerns raised by patients like Moxley and their doctors, but also because brand-name biologics have kept biosimilars from entering the market. The companies behind the brand-name drugs have used legal actions to extend the life of their patents and incentives that make offering the brand biologic more attractive than offering a biosimilar on a formulary, listing which drugs are covered on an insurance plan.

“It distorts the market and makes it so that patients can’t get access,” said Dr. Jinoos Yazdany, a professor of medicine and chief of the rheumatology division at Zuckerberg San Francisco General Hospital.

The FDA has approved 31 biosimilar medications since 2015, but only about 60% have made it to market, according to an analysis by NORC, a research organization at the University of Chicago.

Remicade’s manufacturer, Johnson & Johnson, and Pfizer, which makes the Remicade biosimilar Inflectra, have been embroiled in a long-running lawsuit over Pfizer’s claims that Johnson & Johnson tried to choke off competition through exclusionary contracts with insurers and other anti-competitive actions. In July, the companies settled the case on undisclosed terms.

In a statement, Pfizer said it would continue to sell Inflectra in the U.S. but noted ongoing challenges:

“Pfizer has begun to see progress in the overall biosimilars marketplace in the U.S. However, changes in policy at a government level and acceptance of biosimilars among key stakeholders are critical to deliver more meaningful uptake so patients and the healthcare system at-large can benefit from the cost savings these medicines may deliver.”

Johnson & Johnson said it is committed to making Remicade available to patients who choose it, which “compels us to compete responsibly on both price and value.”

‘Highly Similar’ Drugs

Biologic medicines, which are generally grown from living organisms such as animal cells or bacteria, are more complex and expensive to manufacture than drugs made from chemicals. In recent years, biologic drugs have become a mainstay of treatment for autoimmune conditions like Crohn’s disease and rheumatoid arthritis, as well as certain cancers and diabetes, among other conditions.

Other drugmakers can’t exactly reproduce these biologic drugs by following chemical recipes as they do for generic versions of conventional drugs.

Instead, biosimilar versions of biologic drugs are generally made from the same types of materials as the original biologics and must be “highly similar” to them to be approved by the FDA. They must have no clinically meaningful differences from the biologic drug, and be just as safe, pure and potent. More than a decade after Congress created an approval pathway for biosimilars, they are widely accepted as safe and effective alternatives to brand biologics.

Medical experts hope that as biosimilars become more widely used they will increasingly provide a brake on drug spending.

From 2015 to 2019, drug spending overall grew 6.1%, while spending on biologics grew more than twice as much — 14.6% — according to a report by IQVIA, a health care analytics company. In 2019, biologics accounted for 43% of drug spending in the U.S.

Biosimilars provide a roughly 30% discount over brand biologics in the U.S. but have the potential to reduce spending by more than $100 billion in the next five years, the IQVIA analysis found.

In a survey of 602 physicians who prescribe biologic medications, more than three-quarters said they believed biosimilars are just as safe and effective as their biologic counterparts, according to NORC.

But they were less comfortable with switching patients from a brand biologic to a biosimilar. While about half said they were very likely to prescribe a biosimilar to a patient just starting biologic therapy, only 31% said they were very likely to prescribe a biosimilar to a patient already doing well on a brand biologic.

It can be challenging to find a treatment regimen that works for patients with complicated chronic conditions, and physicians and patients often don’t want to rock the boat once that is achieved.

In Moxley’s case, for example, before her condition stabilized on Remicade, she tried a conventional pill called Lialda, the biologic drug Humira and a lower dose of Remicade.

Some doctors and patients raise concerns that switching between these drugs might cause patients to develop antibodies that cause the drugs to lose effectiveness. They want to see more research about the effects of such switches.

“We haven’t seen enough studies about patients going from the biologic to the biosimilar and bouncing back and forth,” said Dr. Marcus Snow, chair of the American College of Rheumatology’s Committee on Rheumatologic Care. “We don’t want our patients to be guinea pigs.”

Manufacturers of biologic and biosimilar drugs have participated in advertising, exhibit or sponsorship opportunities with the American College of Rheumatology, according to ACR spokesperson Jocelyn Givens.

But studies show a one-time switch from Remicade to a biosimilar like Inflectra does not cause side effects or the development of antibodies, said Dr. Ross Maltz, a pediatric gastroenterologist at Nationwide Children’s Hospital in Columbus, Ohio, and former member of the Crohn’s & Colitis Foundation’s National Scientific Advisory Committee. Studies may be conducted by researchers with extensive ties to the industry and funded by drugmakers.

Situations like Moxley’s are unusual, said Kristine Grow, senior vice president of communications at AHIP, an insurer trade group.

“For patients who have been taking a brand-name biologic for some time, health insurance providers do not typically encourage them to switch to a biosimilar because of a formulary change, and most plans exclude these patients from any changes in cost sharing due to formulary changes,” she said.

Drugmakers can seek approval from the FDA of their biosimilar as interchangeable with a biologic drug, allowing pharmacists, subject to state law, to switch a physician’s prescription from the brand drug, as they often do with generic drugs. However, the FDA has approved only one biosimilar (Semglee, a form of insulin) as interchangeable with a biologic (Lantus).

Like Moxley, many other patients using biologics get copay assistance from drug companies, but the money often isn’t enough to cover the full cost. In her old job as a radio reporter, Moxley said, she hit the $7,000 maximum annual out-of-pocket spending limit for her plan by May.

In her new job, Moxley has an individual plan with a $4,000 maximum out-of-pocket limit, which she expects to blow past once again within months.

But she received good news recently: Her new plan will cover Remicade.

“I’m still concerned that I will have developed antibodies since my last dose,” she said. “But it feels like a step in the direction of good health again.”

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

AMA: ‘Time to Change Course’ on Overdose Epidemic

By Pat Anson, PNN Editor

With the U.S. facing a record number of drug deaths, the American Medical Association is calling for major changes in the way healthcare providers, insurers, and state and federal policy makers combat the overdose epidemic.

“It’s time to change course,” the AMA says in a new report that documents a 44% decrease in opioid prescribing nationwide over the past decade. At the same time, however, overdose deaths continued rising, fueled primarily by illicit fentanyl, heroin, cocaine and other street drugs.

“With record-breaking numbers of overdose deaths across the country, these are actions policymakers and other stakeholders must take,” AMA President Gerald Harmon, MD, said in a statement. “The focus of our national efforts must shift. Until further action is taken, we are doing a great injustice to our patients with pain, those with a mental illness and those with a substance use disorder.”

The AMA report calls for the CDC to “restore compassionate care for patients with pain” by rescinding “arbitrary thresholds” for opioid doses recommended in the agency’s 2016 prescribing guideline.  Although voluntary and only intended for primary care providers treating chronic pain, the guideline has been widely adopted as a standard of care by states, insurers, pharmacies and physicians of all specialties.

Doctors have also made liberal use of Prescription Drug Monitoring Programs (PDMPs), looking for signs of patients “doctor shopping” or abusing their medications. The databases, which track prescriptions for opioids and other controlled substances, have been accessed 2.7 billion times by physicians, regulators and law enforcement since 2014. State PDMPs were utilized over 910 million times in 2020 alone, according to the AMA.  

As a result of these and other measures to limit opioid prescriptions, millions of pain patients have been tapered to lower doses or completely cutoff from opioids -- yet drug deaths continue rising.

From January, 2020 to January, 2021, over 94,000 Americans died of drug overdoses, the most ever over a 12-month period.

A recent study by the Reason Foundation found that PDMP’s may be making the opioid crisis worse by forcing legitimate patients to turn to street drugs because they lost access to pain medication.

SOURCE: AMA

“The nation’s drug overdose and death epidemic has never just been about prescription opioids,” said Harmon. “We use PDMPs as a tool, but they are not a panacea. Patients need policymakers, health insurance plans, national pharmacy chains and other stakeholders to change their focus and help us remove barriers to evidence-based care.”

One such barrier is limited access to addiction treatment. Although over 100,000 healthcare providers can now prescribe buprenorphine (Suboxone) for the treatment of opioid use disorder, the AMA estimates 80 to 90 percent of people with a substance abuse problem receive no treatment.

The AMA urged policymakers to take these steps:

• Ensure access to affordable treatment for patients with pain, including opioid therapy, by rescinding arbitrary laws and policies that restrict access to pain care.

• Stop insurers from using step therapy and prior authorization to deny or delay treatment for opioid use disorder and other needed medical care.

• Support harm reduction services such as needle and syringe exchange services.

• Make overdose reversal medications like naloxone available over the counter.

• Decriminalize fentanyl test strips and other drug checking supplies.

• Ensure settlement money from opioid litigation cases is used only for public health services.

• Remove structural barriers to healthcare in marginalized and minority communities.

• Improve databases to better track non-fatal overdoses, polysubstance use and local trends in drug use.

“To make meaningful progress towards ending this epidemic, a broad-based public health approach is required. This approach must balance patients’ needs for comprehensive pain management services, including access to non-opioid pain care as well as opioid analgesics when clinically appropriate, with efforts to promote appropriate prescribing, reduce diversion and misuse,” Harmon said.

In recent years, the AMA has become increasingly vocal about the declining quality of pain care in the U.S. and the CDC guideline in particular. In a recent letter to the CDC, the chair of the AMA board said patient stigma and the undertreatment of pain were “a direct result” of the 2016 guideline. The CDC is currently considering an update and possible expansion of the guideline, although a draft revision contains the same dose recommendations as the original guideline.  

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

The AMA’s opposition to the guideline drew a rebuke from the anti-opioid activist group Physicians for Responsible Opioid Prescribing (PROP). In a February letter to the AMA, PROP’s board said opioid prescribing for pain was still problematic and “a common gateway to illicit opioid use.” The letter also said that opioid medication should only be used for short-term acute pain and end-of-life care.     

Another Drug Shortage Caused by Covid-19 Has Me Worried

By Victoria Reed, PNN Columnist

I recently read a news article about the Food and Drug Administration issuing an emergency use authorization for Actemra (tocilizumab) for the treatment of hospitalized covid-19 patients. The medication was originally developed as a treatment for rheumatoid arthritis (RA), one of the chronic pain conditions I live with.  

Actemra is a biologic drug that calms down overactive immune systems by blocking the interleukin-6 (IL-6) receptor. Persistent dysregulated expression of the IL-6 receptor is involved in the pathogenesis of RA and other chronic inflammatory and autoimmune diseases. It is believed that this over-activation of the IL-6 receptor is also responsible for the so-called “cytokine storm” that causes severe illness and death in covid-19 patients.

The symptoms of RA are pain, fatigue and swelling in the lining of the joints and other parts of the body, including the heart, lungs and eyes. This inflammation can lead to disability, joint destruction and cause serious damage to the lungs and heart.

I have had long-term success controlling my RA symptoms with Actemra and have been getting the drug by IV infusion monthly for about 8 years. Prior to that, I didn’t have good control with other biologic meds such as Enbrel and Orencia.

When I read that news story, I was initially only mildly concerned about Actemra becoming unavailable. Nevertheless, I contacted my doctor for confirmation that I was still on track for my upcoming monthly infusion. However, she did not and could not confirm that the medication would be available to me. Why?

Actemra has now been hijacked by doctors treating covid-19 patients, and this has created a major shortage. I have been informed that its availability for RA patients is uncertain for the foreseeable future. This is really very upsetting!

Covid-19 patients are using up resources in hospitals across the country. The overwhelming needs of these severely ill patients are causing other patients who need surgery or have treatable illnesses to die from a lack of available resources. Hospitals in hard-hit areas are short on everything -- staff, meds, beds and time. As a result, many chronic pain patients like me are being denied the treatments that we rely on to have functional lives. I must say that this seems patently unfair.

What’s even more disconcerting is that Genentech, Actemra’s manufacturer, can’t say when the shortage will end and expects “additional intermittent periods of stockouts (lack of supply) in the months ahead, especially if the pandemic continues at the current pace.”

RA and lupus patients saw this happen earlier in the pandemic when word got out that Plaquenil (hydroxychloroquine) might help treat covid-19. That medication also became scarce and was inaccessible to patients with autoimmune conditions for a while.  

One thing for sure is we are all very tired of the covid virus and its variants. I understand that doctors and scientists are desperate to find things that work, and they want to save lives. But I rely on Actemra to help relieve my pain and fatigue and keep damaging inflammation down. It is the mainstay of my treatment.  

Due to the Actemra shortage, I may have to consider other medications that might not work as well or just wait out the shortage and hope my disease activity doesn’t become unbearable.  

If the pandemic continues, many more people are going to lose their lives from covid infections. However, all patients deserve an equal chance at receiving the care they need, including chronic pain patients. The pain community is already suffering from opioid hysteria and many of us have to fight to stay on these pain medications. We shouldn’t have to fight for our other meds too! 

RA is a serious, systemic and often misunderstood condition that can shorten a lifespan by many years if not treated aggressively and with the proper medications.  Patients sometimes go through many trials of medications before finding one that relieves symptoms and arrests disease activity.  

I truly hope this shortage is short-lived -- for myself and others like me -- who rely on Actemra to remain functional and productive.  

Victoria Reed lives in Cleveland, Ohio. She suffers from endometriosis, fibromyalgia, degenerative disc disease and rheumatoid arthritis.

Low Dose Naltrexone Being Studied as Treatment for CRPS

By Pat Anson, PNN Editor

Low-dose naltrexone (LDN) is already being used to treat a wide variety of chronic pain conditions, from fibromyalgia and interstitial cystitis to Ehlers Danlos syndrome and temporomandibular joint disorder (TMJ). Some doctors believe the drug may even be useful treating symptoms of a condition so painful it’s been called the “suicide disease.”

Soin Therapeutics, a small pharmaceutical startup based in Ohio, announced this month it has been granted orphan drug status from the Food and Drug Administration to explore using LDN as a treatment for Complex Regional Pain Syndrome (CRPS), a disorder of the nervous system that causes severe, intractable nerve pain.

"Obtaining Orphan Status from the FDA is an important milestone step for us at Soin Therapeutics. We look forward to running a large-scale clinical trial and eventually FDA approval to help patients suffering from CRPS," Dr. Amol Soin, the founder and CEO of Soin Therapeutics, said in a statement.

Currently, naltrexone is only approved by the FDA as a treatment for substance abuse. In 50mg doses, the drug blocks opioid receptors in the brain and decreases the desire to take opiates or alcohol. But in smaller doses of 5mg or less, some patients have found LDN to be a surprisingly effective pain reliever.

How LDN works is not fully understood, but supporters believe the drug modulates the immune system, reduces inflammation and stimulates the production of endorphins, chemicals produced by the body that reduce pain and anxiety.

It's important to note that because naltrexone is an opioid antagonist, it should never be taken with opioid medication – even in small doses -- because it may cause severe withdrawal.

"Low Dose Naltrexone has unique properties to specifically help the disease cascade of CRPS including attenuation of microglial cells involved in pain transmission, reduction of proinflammatory cytokines, antagonism of the Toll-like receptor 4 (TLR4), as well as stimulating release of endorphins which are the body's natural pain killers,” said Soin, who is a practicing pain management physician.

“Basically, this drug seems very well suited to treat several mechanisms of the disease process. All those properties would seemingly be quite helpful in CRPS patients. Best of all, this is a non-addicting and non-sedating drug that could be a new way to treat complex regional pain syndrome."

Soin Therapeutics hopes to develop a novel formulation of LDN and submit an Investigational New Drug application to the FDA before starting a clinical trial.

Because the patent on naltrexone expired decades ago, it’s a generic and cheap drug – perhaps the main reason it is not more widely used as a pain reliever. There is little incentive for pharmaceutical companies to market LDN or conduct expensive clinical trials to prove its effectiveness in treating pain.

Patients interested in trying LDN often encounter doctors who refuse to prescribe it “off label” or don’t know anything about it. The LDN Research Trust includes a list of LDN-friendly doctors and pharmacies on its website.