Head-to-Head Migraine Study Ends in Tie

By Pat Anson, PNN Editor

An unusual head-to-head competition between two migraine prevention drugs has ended in a virtual tie. There were no substantial differences in effectiveness between Emgality and Nurtec, according to preliminary results from a clinical trial released by Eli Lilly, the maker of Emgality.

Emgality and Nurtec both inhibit calcitonin gene-related peptides (CGRP), a protein that causes migraine pain, but their delivery systems are different. Emgality is injected once a month, while Nurtec is an oral medication taken every other day made by Biohaven Pharamceuticals, a subsidiary of Pfizer.

Eli Lilly launched the trial in late 2021, enrolling 575 participants in a Phase 4, double-blind, placebo-controlled study evaluating the efficacy and safety of Emgality (galcanezumab) and Nurtec (rimegepant) for 3 months in adults with episodic migraine.

The so-called CHALLENGE-MIG trial was a bold and somewhat risky move by Lilly, as it seeks to gain more market share in the highly competitive $2 billion U.S. migraine market.

In a statement, Lilly said Emgality did not meet the study's primary goal, which was statistical superiority to Nurtec in achieving at least a 50% reduction in monthly migraine headache days. The response rates of patients and safety profiles of both drugs were similar.

Lilly said Emgality was superior to Nurtec in some secondary outcomes, but didn’t disclose what they were. The company would only say that Emgality helped prevent migraines, as it has in previous studies.  

"These results bolster our knowledge of Emgality's ability to work quickly and help patients improve their quality of life with less frequent dosing," Anne White, executive vice president of Eli Lilly, said in a press release. "Reducing the frequency of migraine headache days can help people experience more freedom from the burden of this debilitating neurological disease and get back to participating in the daily activities that matter most to them."

Final result from the CHALLENGE-MIG trial won’t be posted until later this year.

“Nurtec ODT is the first and only medication approved as both an acute treatment for migraine and a preventive treatment for episodic migraine in adults. It offers flexibility to patients in treating their migraines and is the leading prescribed oral CGRP receptor antagonist,” Pfizer said in a statement. “We are confident in the efficacy and tolerability profile of Nurtec ODT as demonstrated in the clinical trials and the well-established patient preference for oral agents over injectables.

First approved by the FDA in 2018, CGRP inhibitors are the biggest innovation in migraine treatment in decades. They are also expensive, whether taken by pill or injection.

The listed cash price for Emgality is $679 for a single injection or $8,148 annually; while 8 tablets of Nurtec cost $1,011 or about $23,000 a year. Costs to patients will vary, depending on insurance coverage, copay assistance programs and rebates.

I’m Already Well Aware

By Mia Maysack, PNN Columnist

If I did not cling to my optimism for dear life, I'd scoff at the concept of an awareness month such as June being nationally recognized as Migraine & Headache Awareness Month.

That’s due to the fact I am someone who has lived with a daily reminder of intractable pain for over two decades. It isn’t those of us who can directly relate to the pain experience that are in need of awareness.

I feel many “awareness” efforts are limited or fall short in terms of gaining recognition for a specific cause or reason. People typically don’t concern themselves with issues that don’t directly affect or impact them.

Someone who hasn’t ever had a migraine couldn’t possibly understand how it differs from a regular stress headache. Furthermore, somebody who does experience an occasional migraine still cannot fathom what it would be like to have one on a more constant basis.

What transpires within and throughout our individual lenses of the world is real to us and valid, though different from others. That doesn’t lessen the next person’s experience as being anything less than our own.    

There have been some who have thought of my claims about illness are disingenuous. But the reality is that I actually learned to “fake” wellness, in an effort to create a sense of fulfillment and meaning in my life, despite the hand I’ve been dealt.

Others claim those of us who live with pain should be able to “fix” ourselves, once we acknowledge things like a childhood trauma; or that if we adopt “sufficient water intake” and “sleep hygiene” for example, all will be well.

Although I believe there’s some merit to those suggestions, and that they come from a decent, well-meaning place --- if it were that simple, I would be healed by now, along with millions of others who endure similar circumstances.

For a lot of us, we’ve had to come to terms with the fact that there may not be anything out there to give us back the life we once had or wanted. That’s because we’ve already attempted and tried just about everything in search of pain management or relief.

Often, we’re unable to obtain access to options that might ease our suffering because that process can be a grueling one and often has a ripple effect of further complications, along with a multitude of hoop jumping. That’s why I’ve mostly refrained from making it a habit to ask for professional help. Instead, I have worked on acceptance, as there are not many things that anyone else can do for me.   

Relentless and untreatable ailments in any form are going to take a toll, but I hold steady to the concept of “pain” being a worldwide experience that each and every one of us can relate to in some way or another. Each of us have had moments when we’d do just about anything to have the discomfort end.

But instead of embracing the potential for common ground, we as a society tend to label people, when the cure is to be found in seeing and treating one another as fellow human beings. We never truly know where a person may be in regards to their mental health or quality of life, and need not make this already challenging existence any more difficult for ourselves or each other.

Given the extent I’ve witnessed how our healthcare system fails us, I had to choose to not identify with the victim mentality or wait any longer for answers elsewhere.  Ultimately, I stumbled upon empowerment in owning my situation, by tending to myself in ways that I am able. That was my education in self-awareness.

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. 

Ketamine Nasal Spray May Be Effective Migraine Treatment

By Pat Anson, PNN Editor

In recent years, ketamine has become a trendy drug for treating depression, anxiety, post-traumatic stress and some types of chronic pain. Usually administered by infusion or injection, ketamine is a non-opioid analgesic that acts on the brain by putting patients into a temporary dream-like state.

A new study at Thomas Jefferson University suggests that ketamine may also be an effective treatment for chronic migraine. Several previous trials have shown that intravenous ketamine is effective for chronic headache, but it required close monitoring by a pain specialist to adjust the dose and monitor any side effects.

In the new study, researchers gave 169 migraine patients a ketamine nasal spray that they could use at home without supervision. Over two-thirds of the participants suffered from daily headaches and nearly 85% had tried over 3 types of migraine prevention drugs, with limited success.

The study findings, published in the journal Regional Anesthesia & Pain Medicine, showed that nearly half the participants said the nasal spray was “very effective” and about 40% found it “somewhat effective.” Over a third said their quality of life was “much better.” 

Nearly 3 in 4 patients reported at least one side effect from ketamine, the most common being fatigue and double/blurred vision, followed by cognitive effects such as confusion, dissociation, vivid dreams and hallucinations. Most of the side effects were only temporary.

“In this descriptive study, intranasal ketamine served as an acute treatment for refractory chronic migraine by reducing headache intensity and improving quality of life with relatively tolerable adverse events. Most patients found intranasal ketamine effective and continued to use it despite these adverse events,” wrote lead author Michael Marmura, MD, Outpatient Director at the Jefferson Headache Center.

Marmura and his colleagues are cautious about who should use ketamine because of its potential for abuse. Ketamine has a short half-life of less than two hours, meaning patients may be tempted to use it repeatedly to keep chronic headaches at bay. Patients in this study used the nasal spray an average of just 6 times a month, but a small number (13.9%) used the spray daily.

“Clinicians should only consider the use of a potentially addictive medication such as ketamine for significantly disabled patients with migraine,” they warned. “(This) should be addressed carefully and individually, as some may respond only to repeated ketamine, while some may overuse it.”

In 2019, the FDA approved the use of Spravato, a nasal spray that contains a ketamine-like substance, for severe depression. Because of the risk of abuse, Spravato can only be administered in a doctor’s office, where patients can be observed for two hours after taking a dose. The use of such a spray to treat migraine would be considered an off-label use.

In addition to its medical uses, ketamine has long been known as a party drug – “Special K” -- because it can cause hallucinations and intense, dream-like states.

It didn’t take long for drug dealers to note the increase in ketamine’s popularity. Recent research published in JAMA shows that seizures of illicit ketamine in the U.S. have risen from 55 seizures in 2017 to 247 in 2022, a 350% increase. Because much of its was seized in powder form, researchers are concerned black market ketamine could easily be adulterated with illicit fentanyl.

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. 

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.

Why Women Are More Likely to Suffer Migraines

By Pat Anson, PNN Editor

German scientists may have finally proven a link between hormones and migraines, and why women suffer migraines at triple the rate that men do. In studies on animals and humans, researchers found that calcitonin gene-related peptides (CGRPs) increase in females during menstruation.

CGRP is a protein that binds to nerve receptors and dilates blood vessels in the brain, causing migraine pain. Several medications are now on the market that inhibit CGRP, one of the biggest innovations in migraine treatment in decades.

“This elevated level of CGRP following hormonal fluctuations could help to explain why migraine attacks are more likely during menstruation and why migraine attacks gradually decline after menopause,” says Bianca Raffaelli, MD, of Charité – Universitätsmedizin Berlin in Germany. “These results need to be confirmed with larger studies, but we’re hopeful that they will help us better understand the migraine process.”

Raffaelli and her colleagues measured CGRP levels in the blood and tear fluid of 180 women during their menstrual cycles, and found that those who suffer from episodic migraines had significantly higher concentrations of CGRP during menstruation, when estrogen levels are low.

“This means that when estrogen levels drop immediately before the start of a menstrual period, migraine patients release more CGRP,” said Raffaelli, lead author of a study published in the journal Neurology. “This could explain why these patients suffer more migraine attacks just before and during their monthly period.”

In women who take oral contraceptives, there were hardly any fluctuations in their estrogen or CGRP levels. The same was true for postmenopausal women.

“Taking birth control pills and the end of menopause do in fact bring relief for some female migraine patients. But as our study also shows, there are women who suffer from migraine even without any hormonal fluctuations. We suspect that other processes in the body play a role in triggering attacks in those patients. After all, CGRP isn’t the only inflammatory peptide that can cause a migraine attack,” said Raffaelli.

The study also suggests that measuring CGRP levels in tear fluid is feasible and warrants further investigation, because accurately measuring CGRP in the blood is challenging due to its short half-life.

The research team now plans to study how other physical processes are influenced by the menstrual cycle, such as blood vessels and brain function. They also plan to take a closer look at CGRP levels in men of varying age groups.

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, blurriness or visual disturbances, and sensitivity to light and sound.

New Test Predicts Effectiveness of CGRP Drugs for Migraine

By Pat Anson, PNN Editor

CGRP inhibitors have been one of the biggest innovations in migraine treatment in decades. CGRP stands for calcitonin gene-related peptides, a protein that binds to nerve receptors in the brain and triggers migraine pain. Since 2018, the FDA has approved over half a dozen CGRP inhibitors for migraine prevention and treatment.

The problem with anti-CGRP therapies – besides their high cost – is that they only work for about half the people who take them.

A new test may take some of the guesswork out of CGRP therapy, by predicting with about 80% accuracy which patients will respond to CGRP inhibitors before treatment begins.  In a small study published in the journal Cephalalgia, Harvard Medical School researchers found that most migraine patients with non-ictal cephalic allodynia -- pain sensitivity experienced in-between migraine attacks – did not respond to CGRP treatment. Conversely, most patients without non-ictal cephalic allodynia did respond to CGRP therapy.  

Determining which patients have or don’t have cephalic allodynia is relatively easy, through a novel Quantitative Sensory Testing (QST) algorithm that measures how sensitive patients are to heat, cold and being poked in the skin with a sharp object. The test identified CGRP responders with nearly 80% accuracy and non-responders with nearly 85% accuracy.

“Detection of non-ictal cutaneous allodynia with a simplified paradigm of QST may provide a quick, affordable, non-invasive, and patient-friendly way to prospectively distinguish between responders and non-responders to the prophylactic treatment of migraine with drugs that reduce CGRP signaling,” wrote lead author Rami Burstein, MD, Professor of Anesthesia, Harvard Medical School.

Burstein helped develop the QST test in collaboration with CGRP Diagnostics. The test can be done in about five minutes in a doctor’s office.

“This is all about improving outcomes for people suffering from migraines and so we strongly recommend that all potential anti-CGRP recipients have the test done prior to prescription,” said Mark Hasleton, PhD, CEO of CGRP Diagnostics. 

“This will help provide migraine sufferers with either the best chance for treatment success for likely responders, or to enable rapid transition for likely non-responders to other treatment strategies, thus avoiding the misery of treatment failure. CGRP Diagnostics is currently in discussions with multiple key pharma and payor players in this area, with the expectation that such a test will become a prerequisite prior to anti-CGRP prescription.”

A surprise finding from the study is that cutaneous allodynia may be related to genetic factors that cause pain sensitivity, rather than the frequency or severity of migraines.

“This study unveils the mechanism of physiological response to anti-CGRP therapy and could fundamentally change the anti-CGRP therapy field,” said Iris Grossman, PhD, Founding Scientific Advisor at CGRP Diagnostics. “We now have an objective tool to tailor early and effective therapy to migraine sufferers. This novel test holds the potential for earlier access to anti-CGRP therapy, reduced need for prior treatment failures with generics, and enhanced formulary access. It also enables non-responders to rapidly transition to other treatment strategies, preventing a great deal of suffering and frustration for all.”

A 2020 survey of migraine patients by Health Union found that 52% of those who tried a CGRP therapy switched brands because the treatment didn’t work or because they didn’t like the side effects, such as constipation and weight gain.

CGRP medications are not cheap. Eight doses of Nurtec, the migraine treatment endorsed by Khloe Kardashian, can cost over $1,000 without insurance.

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, blurriness or visual disturbances, and sensitivity to light and sound. Women are three times more likely to suffer from migraines than men.

Thinking Outside the Pill Box: Another Approach to Pain Management

By Alon Ironi, CEO, Theranica Bio-Electronics

Well into my adulthood, I struggled with chronic back pain. I took medication after medication, finding myself getting sucked into the habit of popping painkillers and wondering why my pain wasn’t healing. I eventually discovered the psychological and mental elements inherent in chronic pain, and shifted my approach to pain management, which rapidly cured my back pain.  

The holistic approach to healing pain has historically been ridiculed in the medical community, preventing many physicians from recognizing the legitimacy of alternative treatments. The time has come to evolve beyond just popping pills to treat pain, towards a biopsychosocial perspective.  

The discovery and introduction of penicillin in 1928, marked the very beginning of medication popularization in the West. The development of new medications – for a wide range of uses - has extended life span and improved quality of life.  Unfortunately, the benefits associated with medication have encouraged its frequent use for disorders it simply is not meant for, such as certain types of chronic pain.  

Medication overuse headache is one example where drugs intended to treat migraine and headache can, with excessive use, lead to the deterioration of the exact condition they are supposed to be treating. Medication is an incredible tool when used properly, but it’s not the only tool, and it can be seriously harmful when misapplied.

What is Pain and How Do We Treat It? 

Pain is a unique bodily experience that, unlike other disorders, indicates an underlying issue in one’s physiology. Pain is an alarm system. It tells us that something is wrong, and if we mask it without treating its underlying cause, we might cause a great disservice to our bodies.  

The use of medication to treat short-term acute pain, while a person simultaneously heals from the cause of that pain, like a pulled muscle or a tear in a tissue, makes sense. However, the use of medication in instances of chronic pain - pain that persists longer than three months - is problematic.  

Chronic pain is a debilitating condition that impacts an individual’s everyday life. From migraine to chronic knee pain to chronic back pain, the routine of normal life is disrupted. Often, this chronic pain had an initial cause, such as a surgery, fall or injury that has since healed, but the pain persists long after its source has disappeared. This type of pain, as Haider Warraich, a physician and clinical researcher at Harvard, so aptly puts it, is like “an overlearned traumatic memory that keeps ricocheting around in our brains, often long after the injury it rehearses has fully healed.” 

This perception of chronic pain has its roots in quite a controversial physician -the late Jon Sarno, MD, a professor of rehabilitation medicine in the 1980’s and 90’s. His theories, while not rigorously proven in formal clinical studies, were built upon anecdotal data from thousands of patients he treated during his lifetime and are still being explored today. They have jumpstarted a revolution in our understanding of pain.  

The biopsychosocial model focuses on illness as a complex interaction of chemical and electrical reactions that are induced by biological, psychological and social factors. Contemporary pain researchers, like Lorimer Mosely, a clinical scientist, have applied this model to pain, recognizing that pain is comprised of both physical sensation and emotional stimulus, such as the fear of pain itself.  

Pain is no longer perceived as entirely “physical” in nature. It is now understood to be exacerbated by the fear of tissue damage and the aversion to previously experienced pain. As clinical research develops and shifts its focus to a more biopsychosocial approach to illness and pain, doctors must re-evaluate their first-line treatment suggestions. 

Drug-Free Pain Management 

Based on this new perception of pain, several nonpharmacological treatment methods for pain management have been developed. One approach is a purely psychological treatment called cognitive behavioral therapy, a form of talk therapy that discourages negative thoughts associated with pain and trains people to adhere to thoughts that stimulate the body’s natural pain relief system. Another example of nonpharmacological pain treatment is massage therapy,  which addresses pain by releasing muscle tension.  

Neuromodulation is highly effective in treating certain pain disorders through the use of electrical stimulation to modulate pain pathways in the neural system.  Several forms of neuromodulation treatment exist today, with different mechanisms of action and efficacy.  

Spinal cord stimulation, for example, is used to treat back pain and leg pain. But it is highly invasive, with electrodes surgically placed near the spinal cord to send electrical currents to the spine.

Deep brain stimulation is being studied for the relief of chronic pain, but it is also quite invasive, as it involves implanting electrodes into the brain.  

Nerivio is a non-invasive, wearable neuromodulation device made by my company that is FDA-approved for the treatment of acute migraine. Nerivio is self-applied to the upper arm, where it uses remote electrical neuromodulation (REN) to stimulate analgesic neurotransmitters in the pain pathways of migraine. In clinical trials, Nerivio and other REN devices have been shown to be just as effective as pharmacological treatments.  

To be clear, medication is a necessary and beneficial tool for treating infections, reducing fever, managing sickness and much more. However, its use in chronic pain management is sometimes misplaced, especially at a time when newer non-drug therapies are emerging.  

The holistic approach to pain management is the future. It considers the balance and context of a patient’s life and combines multiple modalities for their treatment. People are multifaceted and their treatment should be multifaceted as well. It is my hope and vision that this field of research will continue to develop and will soon be widely embraced by most medical professionals.  

Having experienced the benefits of drug-free pain management first-hand, I truly hope that health care systems will support patients in accessing these much-needed alternative treatments to improve quality of care and life.  

Alon Ironi is the CEO and co-founder of Theranica Bio-Electronics, the developer of Nerivio.

Alon received a Master of Science in Electrical Engineering from Santa Clara University, and a Bachelor’s of Science in Electrical Engineering from the Technion- Israel Institute of Technology.

My Renewed Fight for Disability

By Mia Maysack, PNN Columnist

There are millions of people who are figuratively standing in line, waiting to be granted benefits under Social Security Disability Insurance or SSDI. It usually begins with a person filing a disability application on their own behalf, declaring that they are unable to work, followed by the certification of medical professionals. They are the first baby steps in what can be a very long process. My application took four years before it was approved.

To get it, I represented myself in a court of law and essentially begged on my knees, pleading with detailed reasoning as to why my personal situation affects and at times strictly prohibits any version of what could be considered my working “ability,” let alone “normalcy.”

Not too long ago, I received a notice that a decision was to be made on whether or not I still live with a post-bacterial meningitis related traumatic brain injury that causes intractable and chronic mega-migraines, along with cluster headaches and nerve damage. I do, in case anybody was wondering.

But after two Social Security assigned medical reviews, it was declared that I am no longer disabled. News to me! The memo must have gotten lost because my body has yet to receive it.

Having worked since the age of 14, up until a few years ago, and only after pushing myself almost to the point of death, the disability checks I’ve been receiving consist of money I contributed to the taxpayer pot. I was grateful for it, knowing that many others have it worse in their own ways, even though the dollar amount is limited to covering a shelter over my forever hurting head.

The gift has been not to have to wrack my brain any further, figuring out where I can live. This has been a blessing, because I am then able to promote the full-time job that is self-care demanded by my ailments.

Constructing a non-mainstream path and not allowing challenges to completely dictate or entirely limit my overall quality of life does not lessen what I endure. Nor does it suggest having been cured or even improved.

It is generally understood that a governing “system” is in place to protect those of us who are not attempting to cheat or scheme to get disability. But let me tell you, our skeletal, muscular, nervous, endocrine, cardiovascular, lymphatic, respiratory, digestive, urinary and reproductive systems are continuously being violated and discriminated against by that very same “system.”  

The mourning of past lives and broken dreams is a permanent condition for me. The trauma of living and reliving what has transpired never ends. My symptoms are chronic and unpredictable, which inconveniences no one more so than it does me.

My body, my rights?  My ass.

Whether I can walk on the date of my upcoming appeal or have to crawl, I’ll fight however I can to make these points heard on behalf of everybody.           

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. Mia is also the recipient of the International Pain Foundation’s “Hero of Hope” award for 2022.

Women Losing Access to Arthritis Drugs Due to Abortion Bans

By Pat Anson, PNN Editor

It didn’t take long for last month’s Supreme Court decision overturning Roe v. Wade to have a ripple effect on the U.S. healthcare system – including unintended consequences for women of childbearing age who have painful conditions such as lupus, rheumatoid arthritis, migraine and multiple sclerosis (MS).

Methotrexate and other drugs used to treat autoimmune and neurological conditions can also be used to induce abortions because they prevent cells from dividing. Although not commonly used for that purpose, methotrexate is officially listed in Texas as an “abortion-inducing drug” – an abortifacient -- putting practitioners at risk of running afoul of the state’s $10,000 bounty on anyone who helps a woman end a pregnancy after six weeks.

Even in states where abortion is legal, physicians, pharmacists and other healthcare providers have become cautious about prescribing or dispensing methotrexate.

“I received an email from my rheumatologist today that they are stopping all refills of methotrexate because it is considered an abortifacient,” a Virginia woman with lupus posted on Twitter just days after Roe was overturned. “If this is happening in a blue state with no trigger law, think of those in red states where abortion isn’t even legal. And those states that have trigger laws causing extreme and immediate loss of access.”

On the same day Roe was overturned, another poster on Twitter said his wife’s rheumatologist took all his female patients off medications that might cause a miscarriage

“So those patients are going to have to go off the drugs that were helping to control their condition and have worse health outcomes. People are going to die because of this,” he said.

The Lupus Foundation of America and Arthritis Foundation said they were aware of the situation and encouraged affected patients to contact them directly.

In an op/ed published in JAMA Neurology, neurologists at UC San Francisco School of Medicine warn the new abortion limits could have life-changing and life-threatening consequences for women with migraine, MS and epilepsy.

"Even if prescribed for a neurological condition, there are reports from patients across the country stating they are now unable to access methotrexate because it can also be used to induce abortion," wrote lead author Sara LaHue, MD, of the UCSF Department of Neurology. "This could increase risk of morbidity, mortality and irreversible disability accumulation for women with neurologic diseases."

Ironically, some treatments for neurological conditions also increase the likelihood of an unplanned pregnancy because they reduce the effectiveness of hormonal contraceptives. Physicians may become reluctant to prescribe those drugs to women of childbearing age.

Some neurologists may also rule out the use of monoclonal antibodies for women — not because they are used in abortions, but because they may harm a fetus.

"In many settings, women with MS are treated with less effective therapies, because these medications are perceived to be safer in pregnancy," said co-author Riley Bove, MD, of the UCSF Department of Neurology. "Often, neurologists are not familiar with how to time or optimize certain medications, or of their updated safety profile. The reversal of Roe v. Wade may reinforce decisions to stick with the less effective therapies, which may result in irreversible disability for some women with MS."

This week the Health and Human Services Department (HHS) warned retail pharmacies they are at risk of violating federal civil rights law if they deny women access to medications used in abortions. The warning specifically mentions methotrexate when its prescribed to someone with rheumatoid arthritis or some other disabling condition.

“If the pharmacy refuses to fill the individual’s prescription or does not stock methotrexate because of its alternate uses, it may be discriminating on the basis of disability,” HHS said..

Migraine Sufferers Have Treatment Options Besides Medication

By Dr. Danielle Wilhour

Migraine headaches currently affect more than one billion people across the globe and are the second-leading cause of disability worldwide. Nearly one-quarter of U.S. households have at least one member who suffers from migraines. An estimated 85.6 million workdays are lost as a result of migraine headaches each year.

Yet many who suffer with migraine dismiss their pain as simply a bad headache. Rather than seeking medical care, the condition often goes undiagnosed, even when other incapacitating symptoms occur alongside the pain, including light and sound sensitivity, nausea, vomiting and dizziness.

Researchers have discovered that genetics and environmental factors play a role in the condition of migraine. They happen when changes in your brainstem activate the trigeminal nerve, which is a major nerve in the pain pathway. This cues your body to release inflammatory substances such as CGRP, short for calcitonin gene-related peptide. This molecule, and others, can cause blood vessels to swell, producing pain and inflammation.

Medication Has Its Limits

A migraine can be debilitating. Those who are experiencing one are often curled up in a dark room accompanied by only their pain. Attacks can last for days; life is put on hold. The sensitivity to light and sound, coupled with the unpredictability of the disease, causes many to forego work, school, social gatherings and time with family.

Numerous prescription medications are available for both the prevention and treatment of migraine. But for many people, conventional treatment has its limitations. Some people with migraine have a poor tolerance for certain medications. Many can’t afford the high cost of the medicines or endure the side effects. Others are pregnant or breastfeeding and can’t take the medications.

However, as a board-certified neurologist who specializes in headache medicine, I’m always amazed at how open-minded and enthusiastic patients become when I discuss alternative options.

Your brain sends you warning signals, such as fatigue and mood changes, to let you know a migraine may be on the way.

These approaches, collectively, are called complementary and alternative medicine. It might be surprising that a traditionally trained Western doctor like me would recommend things like yoga, acupuncture or meditation for people with migraine. Yet in my practice, I value these nontraditional treatments.

Research shows that alternative therapies are associated with improved sleep, feeling better emotionally and an enhanced sense of control. Some patients can avoid prescription medications altogether with one or more complementary treatments. For others, the nontraditional treatments can be used along with prescription medication.

These options can be used one at a time or in combination, depending on how severe the headache and the cause behind it. If neck tension is a contributor to the pain, then physical therapy or massage may be most beneficial. If stress is a trigger, perhaps meditation would be an appropriate place to start. It is worth talking to your provider to explore which options may work best for you.

Mindfulness and Meditation

Because stress is a major trigger for migraines, one of the most effective alternative therapies is mindfulness meditation, which is the act of focusing your attention on the present moment in a nonjudgmental mindset. Studies show that mindfulness meditation can reduce headache frequency and pain severity.

Another useful tool is biofeedback, which enables a person to see their vital signs in real time and then learn how to stabilize them.

For example, if you are stressed, you may notice muscle tightness, perspiration and a fast heart rate. With biofeedback, these changes appear on a monitor, and a therapist teaches you exercises to help manage them. There is strong evidence that biofeedback can lessen the frequency and severity of migraine headaches and reduce headache-related disability.

Yoga derives from traditional Indian philosophy and combines physical postures, meditation and breathing exercises with a goal of uniting the mind, body and spirit. Practicing yoga consistently can be helpful in reducing stress and treating migraine.

Meditation is an alternative therapy that could help with your migraine.

Physical Therapy

Physical therapy uses manual techniques such as myofascial and trigger-point release, passive stretching and cervical traction, which is a light pulling on the head by a skilled hand or with a medical device. Studies show that physical therapy with medication was superior in reducing migraine frequency, pain intensity and pain perception over medications alone.

By lowering stress levels and promoting relaxation, massage can decrease migraine frequency and improve sleep. It may also reduce stress in the days following the massage, which adds further protection from migraine attacks.

Some patients are helped by acupuncture, a form of traditional Chinese medicine. In this practice, fine needles are placed in specific locations on the skin to promote healing. A large 2016 meta-analysis paper found acupuncture reduced the duration and frequency of migraines regardless of how often they occur. Acupuncture benefits are sustained after 20 weeks of treatment.

What’s also fascinating is that acupuncture can change the metabolic activity in the thalamus, the region of the brain critical to pain perception. This change correlated with a decrease in the headache intensity score following acupuncture treatment.

Vitamins, Supplements and Nutraceuticals

Herbal supplements and nutraceuticals, which are food-derived products that may have therapeutic benefit, can also be used to prevent migraine. And there is evidence to suggest vitamins work reasonably well compared to traditional prescription medication. They also have fewer side effects. Here are some examples:

• Magnesium is believed to help regulate the blood vessels and electrical activity in the brain. A study found that patients given 600 milligrams of magnesium citrate daily for 12 weeks had a 40% decrease in migraine. Side effects included diarrhea in nearly 20% of patients.

• Vitamin B2, or riboflavin, is also considered useful in migraine prevention. When dosed at 400 milligrams daily for 12 weeks, researchers found it reduced migraine frequency by half in more than half of participants.

• Another beneficial supplement is Coenzyme Q10, which is involved in cellular energy production. After three months, about half of those taking 100 milligrams of Coenzyme Q10 three times a day had half the number of migraine attacks.

• A potential natural solution is feverfew or Tanacetum parthenium, a daisylike perennial plant known to have anti-migraine properties. Taken three times daily, feverfew reduced migraine frequency by 40%.

Medical Devices

The Food and Drug Administration has approved several neurostimulation devices for migraine treatment. These devices work by neutralizing the pain signals sent from the brain.

One is the Nerivio device, which is worn on the upper arm and sends signals to the brainstem pain center during an attack. Two-thirds of people report pain relief after two hours, and side effects are rare.

Another device that shows promise is the Cefaly. It delivers a mild electrical current to the trigeminal nerve on the forehead, which can lessen the frequency and intensity of migraine attacks. After one hour of treatment, patients experienced a nearly 60% reduction in pain intensity, and the relief lasted up to 24 hours. Side effects are uncommon and include sleepiness or skin irritation.

These alternative therapies help treat the person as a whole. In just my practice, many success stories come to mind: the college student who once had chronic migraine but now has rare occurrences after a regimen of vitamins; the pregnant woman who avoided medication through acupuncture and physical therapy; or the patient, already on numerous prescription medications, who uses a neurostimulation device for migraine instead of adding another prescription.

Granted, alternative approaches are not necessarily miracle therapies, but their potential to relieve pain and suffering is notable. As a physician, it is truly gratifying to see some of my patients respond to these treatments.

Danielle Wilhour, MD, is an Assistant Professor of Neurology, University of Colorado Anschutz Medical Campus. Her primary interests include non-pharmacologic treatment of headache as well as headache during pregnancy.  Danielle does not work for, consult, own shares in or receive funding from any company or organization that would benefit from this article.

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

Advocacy and Awareness Should Promote Healing, Not Division

By Mia Maysack, PNN Columnist

June is Migraine and Headache Awareness Month in the United States. This year’s theme is “Advocate for Access.” 

Although I understand the intent behind awareness months, to those of us who truly live with a non-stop condition, they can border on being a tad mundane. Especially when the execution of the awareness itself does very little to propel us forward in any meaningful way.

I live with deeply rooted and untreatable nerve damage from an incurable traumatic brain injury. Bacterial meningitis almost claimed my life as a child. My brain swelled up and still feels pained and swollen even now -- the very definition of intractable pain.  Because migraines are literally my each and every day reality, I'm sick and tired of focusing on or talking about them. 

From what I've witnessed, awareness campaigns are often a repetition of the same conversations, among the same people and within the same circles. We as "migraineurs" don't need to continuously hear about what we already know. In my opinion, it's an unnecessary use of precious energy and the impact doesn't go as far as it could. 

The "pain community" generally seems less of a community and more like a clique -- a repeated line up of only certain people’s voices being heard and a select few being invited to participate in events.  

It gets even worse than that:  I recall emerging onto the pain scene out of an absolute last resort. I jumped head first into involvement with every organization I could find and joined several support groups out of sheer desperation. One day, a routine migraine treatment with Botox went horribly awry -- to the point I still deal with the repercussions to this day. 

I immediately logged on to share this experience, not in an attempt to scare anyone but to raise awareness and hopefully assist in others not encountering the same thing I did. I hoped for some compassionate empathy but what I received was the exact opposite. 

I was torn to shreds online by keyboard warriors claiming not to feel well enough to physically function, but clearly energized to the point of dragging me down. Before I was given a chance to clarify or further explain, I was muted by administrators. This felt violent, uncalled for and oppressive. I was bullied and shunned at a point in time I couldn’t afford to be. 

These very same individuals have the audacity and nerve to schedule days of remembrance for those who could no longer accept or deal with their pain, while simultaneously playing an active role in pushing people over their edge, probably without even caring or realizing it. 

I view it as a sickness, that a person would demand and expect consideration and respect when they don't demonstrate or possess it for others. It's a contest of underlying comparison as well as competitive victimization: I've hurt longer than you, worse than you, my life has been harder than yours, and no one else's life is as bad as mine.  

Is that really a game you want to win? How could one ever expect to feel better with a fixation like that? 

I've come to realize that many who claim to want improvement aren't truly committed to it. It takes work, a retraining of our minds and an entirely new approach to not only how we care for ourselves, but how we care for others.  

This questionable code of conduct is an illness in itself. The resistance to actual improvement is in part what's keeping members of these groups sick -- not to mention the fact that some remain utterly attached to their conditions to the point they're unsure of any identity outside of them. If those they so faithfully follow were truly interested in the well-being of their devoted followers, they'd be attempting to shine a light on the darkness as opposed to benefiting or profiting from it. 

I remained quiet on this for a long time, but one thing about my advocacy is that it’s real. Some people love that and others hate it. I’m not afraid to burn bridges, especially the ones that I built. In case you haven’t noticed, the whole world is hurting and the healing of our planet is what matters. Not just you and your cause.   

Mia Maysack lives with chronic migraine, 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. 

Lobbying for Better Access to Migraine Care

By Mia Maysack, PNN Columnist

Last week the Alliance for Headache Disorders Advocacy held its 15th annual Headache on the Hill, with over 200 patients and advocates from 48 states visiting close to 300 congressional offices to lobby and raise awareness about migraine and headache disorders. Like last year, most of the participants attended virtually online due to the pandemic. 

As a person living with never-ending head pain from a traumatic brain injury for over two decades, it has been an honor to participate in this event for multiple years. During that time, we've continued to make progress, such as more funding for migraine research, expanding options for symptom management, obtaining access to oxygen therapy, and helping to launch the VA’s Headache Centers of Excellence — which are all meaningful strides towards healthcare reform.

However, I have never been prouder to be a part of this year’s Headache on the Hill (HOH), which had two major “Asks” for our congressional representatives:

Ask #1

Support investment in Headache Centers of Excellence for Indigenous Communities, with $5 million per year in additional appropriations. The goal is to have the Health & Human Services Secretary designate 6 new headache centers in mostly rural reservations, with an emphasis on expanding options for telehealth, so that Native Americans and Alaskan Natives living in isolated areas will be able to connect with and consult with medical professionals online.

Ask #2

Have the General Accountability Office (GAO) issue a report on funding priorities for the National Institutes of Health (NIH), specifically as it relates to headache disorders. Although migraine impacts roughly 40 million Americans and is the main cause of disability for women under 50, migraine research still receives some of the least funding from NIH, even though it has a strategic plan to consider the "burden of individual diseases” when making funding decisions.   

There is a pressing need for more migraine research if we are to find new treatments, invest in viable solutions and alleviate the need for more providers who specialize in treating head pain. Headache and migraine disorders need to be prioritized at NIH -- not above or before any other health condition, but alongside them. 

Government accountability is a part of public service. We need to know in what ways are we moving forward and how our money is being spent.   

Navigating the healthcare system can be challenging. I cannot begin to keep track of the countless hours I've devoted to sitting in waiting rooms at clinics, fighting for insurance coverage, begging for referrals, convincing providers that my ailments are real, and attempting many treatments in desperation for relief.

But as horrendous as my experiences have been at times, nothing compares to the malpractice and neglect that is experienced by patients in marginalized communities. 

It has been documented that Native Americans and Alaskan Natives have the highest rates of disabling headache disorders. They are 40% higher than other races, with a particularly high impact on men. Despite this, Indigenous communities on average have only one neurologist for every 125,000 people!   

Health resources that are caring, regardless of cause or condition, are investments in people. We have huge disparities in equitable care. Why is it that communities with the biggest needs have the fewest resources?

Mia Maysack lives with chronic migraine, 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. 

Advocacy Group Calls on Insurers to Modify Step Therapy for Migraine Treatment

By Pat Anson. PNN Editor

The National Headache Foundation (NHF) is calling on health insurers to stop using rigid “step therapy” policies and make it easier for migraine patients to get access to new treatments.

Step therapy is a common practice in the insurance industry to control costs. It requires patients to try cheaper and often older medications first, before “stepping up” to drugs that cost more.   

“For too long, migraine patients have been treated differently than others with medical issues as it relates to access to prescription medications. Specifically, clinicians are often forced to use outdated prescription drugs in a stepwise approach to all patients, without considering the needs of the individual patient,” said Thomas Dabertin, Executive Director/CEO of NHF, a non-profit that seeks to raise awareness about migraine and headache disorders.  

“Unfortunately, the current care models adopted by payers have not kept pace with the many advances in treatment. As a result, clinicians are using older medications, some of which are not even designed for the specific treatment of migraine, even though new migraine-specific therapies now exist.”

Migraine treatment has been revolutionized in recent years by the introduction of neuromodulation devices and drugs that inhibit calcitonin gene-related peptides (CGRP), proteins that cause migraine pain. CGRP inhibitors cost several thousand dollars a year, while neuromodulation devices usually cost several hundred dollars.

Older drugs used to treat or prevent migraine, such as triptans, antidepressants and over-the-counter pain relievers, are much cheaper and often come in generic formulations. Many Insurers require patients to try at least two of the older medications first -- and for months at a time -- before authorizing newer therapies.

“NHF believes it is inappropriate to require all patients to follow this ‘try two and fail’ model before they may be offered treatment with any FDA-approved migraine preventive, including neuromodulation devices, with established lower adverse event profiles,” the NHF said in a position statement.

“For patients who are highly impacted or disabled by migraine, clinicians should not be directed to deliver outdated models of care that apply a predetermined algorithm in a stepwise approach to all patients, without considering the needs of the individual patient, and that encourage the use of older preventive drugs when targeted and migraine-specific therapies now exist.”

The NHF wants insurers to adopt modified forms of step therapy for migraine sufferers, based on the severity of their disease and the frequency of their attacks.

For patients who have seven or fewer migraine days per month, the NHF recommends that patients be required to try only one generic drug for migraine prevention. For patients who experience 8 or more migraine days per month, the foundation recommends that providers have “unfettered access” to FDA-approved prevention drugs.

For the treatment of acute migraine pain, the NHF recommends that two generic drugs be tried first, but if the drugs fail to work within two hours or have unwelcome side effects, providers be allowed to select “another suitable therapy” based on a patient’s needs.  

“The NHF advocates that payers adopt care models that are patient-centric, where the clinician, in collaboration with the patient, is the primary decision-maker and selects a treatment that addresses the patient’s treatment goals and needs,” Dabertin said.

Although the NHF accepts donations from the pharmaceutical industry, Dabertin told PNN the foundation’s new position statement was based solely on input from patients and providers.