Can ‘Magic Mushrooms’ Help Dying Patients?

By JoNel Aleccia, Kaiser Health News

Back in March, just as anxiety over COVID-19 began spreading across the U.S., Erinn Baldeschwiler of La Conner, Washington, found herself facing her own private dread.

Just 48 and the mother of two teenagers, Baldeschwiler was diagnosed with stage 4 metastatic breast cancer after discovering a small lump on her chest, no bigger than a pea.

Within weeks, it was the size of a golf ball, angry and red. Doctors gave her two years to live.

“It’s heartbreaking,” she said. “Frankly, I was terrified.”

But instead of retreating into her illness, Baldeschwiler is pouring energy into a new effort to help dying patients gain legal access to psilocybin — the mind-altering compound found in so-called magic mushrooms — to ease their physical and psychic pain.

“I have personally struggled with depression, anxiety, anger,” Baldeschwiler said. “This therapy is designed to really dive in and release these negative fears and shadows.”

Erinn Baldeschwiler

Dr. Sunil Aggarwal, a Seattle palliative care physician, and Kathryn Tucker, a lawyer who advocates on behalf of terminally ill patients and chairs a psychedelic practice group at Emerge Law Group, are championing a novel strategy that would make psilocybin available using state and federal “right-to-try” laws that allow terminally ill patients access to investigational drugs.

They contend that psilocybin — whether found in psychedelic mushrooms or synthetic copies — meets the criteria for use laid out by more than 40 states and the 2017 Right to Try Act approved by the Trump administration.

“Can you look at the statute and see by its terms that it applies to psilocybin?” Tucker said. “I think the answer is yes.”

Currently, psilocybin use is illegal under federal law, classified as a Schedule 1 drug under the U.S. Controlled Substances Act, which applies to chemicals and substances with no accepted medical use and a high potential for abuse, such as heroin and LSD.

Recently, however, several U.S. cities and states have voted to decriminalize possession of small amounts of psilocybin. This month, Oregon became the first state to legalize psilocybin for regulated use in treating intractable mental health problems. The first patients will have access beginning in January 2023.

It’s part of a wider movement to rekindle acceptance of psilocybin, which was among psychedelic drugs vilified — and ultimately banned — after the legendary counterculture excesses of the 1960s and 1970s.

“I think a lot of those demons, those fears, have been metabolized in the 50 years since then,” Aggarwal said. “Not completely, but we’ve moved it along so that it’s safe to try again.”

He points to a growing body of evidence that finds that psilocybin can have significant and lasting effects on psychological distress. The Johns Hopkins Center for Psychedelic and Consciousness Research, launched this year, has published dozens of peer-reviewed studies confirming that psilocybin helped patients grappling with major depressive disorder and suicidal thoughts.

Researchers are also looking at psilocybin as a treatment for post-traumatic stress disorder (PTSD), Lyme disease syndrome, cluster headaches and migraines. A small placebo-controlled study by Yale researchers found that migraine sufferers experienced a significant decrease in weekly migraine days after only one dose of psilocybin. 

“Psilocybin was well-tolerated; there were no unexpected or serious adverse events or withdrawals due to adverse events. This exploratory study suggests there is an enduring therapeutic effect in migraine headache after a single administration of psilocybin,” researchers found. 

Psilocybin Shifts Perception

Psilocybin therapy appears to work by chemically altering brain function in a way that temporarily affects a person’s ego, or sense of self. In essence, it plays on the out-of-body experiences made famous in portrayals of America’s psychedelic ’60s.

“What psychedelics do is foster a frame shift from feeling helpless and hopeless and that life is not worth living to seeing that we are connected to other people and we are connected to a universe that has inherent connection,” said Dr. Ira Byock, a palliative care specialist and medical officer for the Institute for Human Caring at Providence St. Joseph Health.

“Along with that shift in perspective, there is very commonly a notable dissolution of the fear of dying, of nonexistence and of loss, and that’s just remarkable.”

The key is to offer the drugs under controlled conditions, in a quiet room supervised by a trained guide, Byock said. “It turned out they are exceedingly safe when used in a carefully screened, carefully guided situation with trained therapists,” he said. “Almost the opposite is true when used in an unprepared, unscreened population.”

The FDA has granted “breakthrough therapy” status to psilocybin for use in U.S. clinical trials conducted by Compass Pathways, a psychedelic research group in Britain, and by the Usona Institute, a nonprofit medical research group in Wisconsin. More than three dozen trials are recruiting participants or completed, federal records show.

But access to the drug remains a hurdle. Though psychedelic mushrooms grow wild in the Pacific Northwest and underground sources of the drug are available, finding a legal supply is nearly impossible.

End of Life Washington, a group focused on helping terminally ill patients use the state’s Death With Dignity Act, recently published a policy that supports psilocybin therapy as a form of palliative care. Other treatments for anxiety and depression, such as medication and counseling, may simply not be practical or effective at that point, said Judith Gordon, a psychologist and member of the group’s board of directors.

“When people are dying, they don’t have the time or the energy to do a lot of psychotherapy,” she said.

Baldeschwiler agrees. With perhaps less than two years to live, she wants access to any tool that can ease her pain. Immunotherapy has helped with the physical symptoms, dramatically shrinking the size of the tumor on her chest. Harder to treat has been the gnawing anxiety that she won’t see her 16-year-old daughter, Shea McGinnis, and 13-year-old son, Gibson McGinnis, become adults.

“They are beautiful children, good spirits,” she said. “To know I might not be around for them sucks. It’s really hard.”

Kaiser Health News (KHN) is a national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation which is not affiliated with Kaiser Permanente.

Pilot Study Finds Green Light Therapy Improves Fibromyalgia Symptoms

By Pat Anson, PNN Editor

Fibromyalgia patients exposed to green light therapy had significant improvements in their pain, sleep and quality of life, according to a new pilot study published in the journal Pain Medicine.

The small clinical trial by researchers at the University of Arizona is the first to explore the benefits of green light in treating fibromyalgia symptoms. Previous studies have focused on green light therapy as a treatment for migraine headaches. Green light is believed to have a calming effect on the brain and causes less eye strain.  

Twenty-one adult patients with fibromyalgia being treated at the university’s chronic pain clinic were enrolled in the study. They were exposed to green light-emitting diodes (GLED) for one to two hours daily for 10 weeks. While undergoing treatment, patients were asked to avoid all other sources of light, including computers, smartphones and television, but encouraged to engage in other activities such as reading and listening to music, and to avoid falling asleep.

“To our knowledge, this one-way crossover design efficacy-study clinical trial is the first description of a successful implementation of GLED exposure as a therapy to manage fibromyalgia pain without any reported side effects. The patients enrolled in this study reported significant reduction in their overall average pain intensity, frequency, and duration after GLED treatment,” wrote lead author Mohab Ibrahim, MD, an associate professor in the Departments of Anesthesiology and Pharmacology at UArizona College of Medicine-Tucson. 

In addition to less pain, patients also reported better mood and sleep, and improvements in their ability to work, exercise and perform chores. Eleven patients said they also reduced their use of pain medication, including opioids, while being exposed to green light.    

“GLED may be a safe and affordable method to manage fibromyalgia. We did not observe side effects in animal studies or in reports from our patients. The observed safety and efficacy, coupled with the simplicity of this method, merit further investigation and the design of a randomized clinical trial to fully investigate the role of GLED for fibromyalgia and possibly other chronic pain conditions,” researchers concluded. 

Fibromyalgia is a poorly understood disorder characterized by widespread body pain, fatigue, poor sleep and depression. Many patients report conventional treatments for fibromyalgia are ineffective or have unwelcome side effects. 

In an email to PNN, Ibrahim said he was conducting two more studies on the use of green light to treat other pain conditions, but was not ready to release his findings. He recently reported the results of a small study of green light as a preventative therapy for migraine. 

“Should anyone use green light products? The risk is low, but I still suggest people speak with their physicians first before attempting any therapy,” Ibrahim said.    

Light Sensitivity 

Although more research is needed to fully understand how green light therapy works, some commercial products are available to the public without a prescription.

One is a portable green light lamp made by Allay, a company founded by Harvard Medical School Professor Rami Burstein, PhD, who was the first researcher to discover that different colors in the light spectrum can affect light sensitivity – known as photophobia – among migraine sufferers.

Burstein learned that blue light (the light emitted by TVs and computer screens) can trigger migraines, while a narrow band of green light at low intensity can reduce the severity of migraine attacks.

“Green light has a calming effect because it reduces electrical activity (in the brain),” Burstein told PNN. “It is the only color of light that is associated with positive emotion and reducing anxiety. All other colors of light increase anxiety, irritability, being afraid, being scared, being angry, a whole host of negative emotions.”

Burstein and his partners asked lighting experts to design an affordable green light lamp that people can use at home. Initial estimates ran in the thousands of dollars, but they have since managed to reduce the cost to $150.

ALLAY IMAGE

“It is safe. It’s not invasive. It is inexpensive,” Burstein says. “Try it. Give it a month or two. If it doesn’t work, you can return it for free. No questions asked.”

Allay began selling the lamps in January with a money back guarantee. Of the 3,000 lamps sold so far, Burstein says less than 4 percent of customers have asked for their money back. He expects an updated version of the lamp to be available by the end of the year for less than $100.

Burstein says the lamp eliminates photophobia in nearly all migraine patients. He recommends that migraine sufferers use the Allay lamp one to two hours every day to reduce the frequency and severity of headaches.

Migraine and Arthritis Patients Report More Pain During Pandemic

By Pat Anson, PNN Editor

Two new surveys are opening a window into how migraine and arthritis patients are managing their pain and getting treatment during the coronavirus pandemic. Many remain fearful about visiting a provider and want insurers to make access to medication easier.

The first survey, conducted by the Headache & Migraine Policy Forum, found a significant increase in stress and migraine attacks in over 1,000 U.S. migraine patients who were surveyed over the summer.

Asked how COVID-19 had impacted their health and treatment, over two-thirds (69%) of patients said they were experiencing an increase in monthly migraines. Eight out of ten (84%) said they felt more stress managing their disease (84%) and over half (57%) said their overall health had worsened.

“Treating a debilitating condition like migraine disease during a global pandemic can increase stress for patients, many of whom already struggle with day-to-day activities. Added stress can mean more frequent attacks, resulting in more visits to see a health care provider or even costly ER visits,” the Policy Forum said.

But while the frequency of migraine attacks increased, many patients were reluctant about seeing a provider and potentially exposing themselves to COVID-19. Six out of ten (61%) said they were afraid to seek care at a doctor’s office or hospital, and 74% were hesitant to visit an emergency room when having an acute migraine attack.

Some insurers have relaxed rules about prior authorization and step therapy to make access to medication easier during the pandemic. But most migraine patients say their own insurers need to be more flexible.

• 72% had difficulty managing their migraine because they couldn’t get a longer supply of medication

• 73% said insurers did not allow them to get more medication per pharmacy fill

• 70% said insurers did not reduce barriers like prior authorization

• 76% said insurers did not stop requiring step therapy

While migraine patients were often unhappy with their insurers, most were delighted with telehealth. The vast majority (83%) said they hoped their providers continued using telehealth after the pandemic ends.

“COVID has introduced a host of new challenges for people living with migraine disease. Telemedicine clearly provides an important link to care, but patients are looking for insurance providers to do more to facilitate care, including cutting red tape and ending delay tactics,” Lindsay Videnieks, Executive Director of the Headache & Migraine Policy Forum said in a statement.

Arthritis Patients Want New Treatments

The second survey of nearly 2,000 adults suffering from osteoarthritis had similar findings. Over a third of respondents (37%) told the Arthritis Foundation that they had missed or cancelled a doctor’s appointment due to fear of COVID-19 infection. Only 15% said their osteoarthritis is well managed.

Osteoarthritis (OA) is a joint disorder that leads to thinning of cartilage and progressive joint damage. No disease-modifying drugs are currently available to treat OA, and over the counter pain relievers have only mild to moderate effects on OA pain.

"Pain is debilitating. My back and hip pain are so bad that I have trouble getting out of bed," said one survey respondent. "Each step is excruciating, and I wonder how much longer I can deal with the pain."

"You spend a lot of time & effort trying not to think about it because what you focus on magnifies," another patient wrote. "You hate pain scales because how do you rate something that is always there? Oftentimes it's not the pain's intensity but rather the duration."

Nearly two-thirds (65%) of patients said they use non-steroidal anti-inflammatory drugs (NSAIDs) or topical medication to manage their pain, 29% use physical therapy or massage, and another 29% said total joint replacement helped.

The primary change OA patients want is for insurers to increase coverage of new arthritis treatments, though more than half said they were only interested in a new treatment for pain if it didn't also increase their joint damage.

The Arthritis Foundation recently joined with 30 other healthcare organizations in asking the Food and Drug Administration and National Institutes of Health to make the development and availability of pain treatments a higher priority within the agencies.

Nearly 80% of People Taking New Migraine Prevention Drugs Report Improvement

By Pat Anson, PNN Editor

Nearly 80% of people taking a new class of medication to prevent migraine say their migraine headaches are “better” since they started taking the drugs, according to a survey conducted by Eli Lilly.

Calcitonin gene-related peptide (CGRP) inhibitors prevent migraines by blocking a key protein released during migraine attacks from binding to nerve receptors in the brain. Since 2018, the FDA has approved three injectable CGRP inhibitors and one oral CGRP medication for migraine prevention. Eli Lilly makes Emgality (galcanezumab), one of the monthly self-injected drugs.

Nearly 600 migraine patients who use CGRP inhibitors participated in the survey, which is part of Lilly’s OVERCOME study, a large web-based survey of migraine sufferers.

While 79.2% said their migraine was better, nearly 10% said it was worse and about 11% said there was no change. The findings were relatively consistent between patients who suffer a handful of migraines each month and those who have them more frequently.

"It is very encouraging that nearly 4 out of 5 people in the survey taking a CGRP monoclonal antibody felt better and reported their migraine had improved," Sait Ashina, MD, a neurologist and scientific advisor to the OVERCOME study, said in a statement.

"It is also notable that the OVERCOME survey reported the clinically meaningful distinction between individuals who reported no change in their migraine with those who said their migraine worsened. This distinction can enhance conversations between the healthcare provider and the patient regarding treatment expectations when considering the use of these novel migraine preventive medications."

Nearly two-thirds (62.6%) of those who used a CGRP inhibitor said they also took another migraine prevention drug, such as topiramate and duloxetine. Use of an additional medication was generally higher among patients who reported frequent migraines.

Lilly presented the survey results this week at the 18th Migraine Trust International Symposium.

The findings are similar to those in a 2019 survey of migraine patients conducted by Health Union. Over half of those using CGRP inhibitors said the benefits of taking the drugs outweighed their side effects. About 9 percent said the medications were not worth the side effects, which include constipation, fatigue and weight gain.

The Health Union survey also found that patients who were not satisfied with a CGRP medication wasted little time switching to a new brand. Most of those who switched said the drugs did not work or stopped working after an initial period of efficacy. 

Lesbian, Gay and Bisexual Americans More Likely to Have Migraines

By Pat Anson, PNN Editor

A groundbreaking survey has found that lesbian, gay and bisexual (LGB) Americans are significantly more likely than straight people to suffer from migraines, according to a research letter published online in JAMA Neurology.

Researchers at University of California-San Francisco surveyed a nationally representative sample of nearly 10,000 adults aged 31 to 42, asking about their sexual orientation and whether they experienced migraine headaches.  

Nearly one third — 30.7 percent — of those who identified as lesbian, gay or bisexual reported having migraines, compared to 19.4 percent of those who said they were exclusively heterosexual.

Interestingly, participants who said they were mostly heterosexual but somewhat attracted to people of the same sex had nearly the same likelihood of migraine (30.3%) as those who identified as lesbian, gay or bisexual.

The researchers did not identify why LGB Americans are more likely to have migraines, but one possibility is the stress of living in families or communities that are not always tolerant of sexual minorities.

“Many members of sexual minority groups experience prejudice, stigma, and discrimination termed sexual minority stress, which could trigger or exacerbate migraine. Furthermore, members of sexual minority groups may encounter barriers to health care and experience greater physical and mental health problems, which could contribute to migraine,” wrote lead author Jason Nagata, MD, an assistant professor of pediatrics at UCSF.

“It is notable that even people identifying as mostly heterosexual had higher odds of migraine compared with those who identified as exclusively heterosexual, in accordance with other physical health disparities noted among nonexclusively heterosexual populations.”

The research is believed to be the first national study to show disparities in migraine based on sexual orientation. Previous studies found a high prevalence of migraine in sexual minorities in California and higher rates of health problems among LGBs who experienced prejudice.    

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.

Study Finds Cannabis Effective for 82% of Migraine Patients

By Pat Anson, PNN Editor

Nearly a third of migraine patients have tried medical marijuana or cannabinoids to relieve their pain and other symptoms, according to a large new study that found 82 percent of those who used cannabis found it effective in providing pain relief.

The study gathered data from nearly 10,000 migraine sufferers in the U.S. and Canada who use Migraine Buddy, a migraine tracking app made by Healint, a healthcare technology company based in Singapore. Participants ingested cannabis by a variety of different methods, such as smoking, vaping, tinctures, oils and edibles. No form of ingestion was signficantly more effective than another.

"Cannabis is becoming a prominent treatment option for chronic pain patients, especially for migraineurs," Healint CEO and co-founder Francois Cadiou said in a press release.

"With more and more states across the United States legalizing medical marijuana, migraine patients are becoming acquainted with cannabis as a natural remedy that can help alleviate migraines and even prevent them. Research about the benefits of cannabis use among migraine patients is slowly emerging, but more must be done to properly inform individuals about the use and dosage of medical marijuana to treat migraines."

The findings are similar to a 2019 study, published in The Journal of Pain, that found inhaled cannabis cut headache and migraine severity in half. The effectiveness of cannabis diminished over time, however, as migraine patients appeared to develop a tolerance for the drug and used larger doses for pain relief.

Another recent study, published in the Journal of Integrative Medicine, reported that 94 percent of migraine sufferers who inhaled cannabis experienced symptom relief within two hours.

A major weakness of all three studies is that there was no control group or use of a placebo, and the data was self-reported by patients on mobile software apps. The Migraine Buddy app allows users to report the duration, frequency and intensity of their migraines and medication use, as well as information about sleep, diet and weather-related triggers.

“Migraines have a debilitating impact on tens of millions of Americans and, in many cases, are poorly addressed by conventional therapies. Therefore, it is not surprising to see a significant percentage of migraine sufferers turning to cannabis as a therapeutic option. Those that do so are consistently reporting it to be safe and effective at reducing both migraine symptoms and migraine frequency,” said Paul Armentano, Deputy Director of NORML, a marijuana advocacy group.

About a billion people worldwide suffer from headaches caused by migraines, which affect three times as many women as men. Over 37 million people in the United States live with migraines, according to the American Migraine Foundation.

Green Light Therapy Reduces Migraine Pain

By Pat Anson, PNN Editor

New research is shining a light on an unusual treatment for migraine headaches: green light therapy.

In a small study involving 29 migraine patients, University of Arizona Health Sciences researchers found that exposure to green light for one to two hours daily reduced headache pain by 60% and significantly reduced the frequency of migraines.

"This is the first clinical study to evaluate green light exposure as a potential preventive therapy for patients with migraine, " said lead author Mohab Ibrahim, MD, an associate professor in the Departments of Anesthesiology and Pharmacology at UArizona College of Medicine-Tucson. "As a physician, this is really exciting. Now I have another tool in my toolbox to treat one of the most difficult neurological conditions: migraine."

Of the 29 patients who participated in the study, seven had episodic migraine and 22 had chronic migraine. All were exposed to white light for one to two hours a day for 10 weeks. After a two-week break, they were exposed to green light for 10 weeks.

Participants also completed regular surveys and questionnaires to track the number and intensity of their headaches, as well as quality of life issues such as the ability to fall and stay asleep or to work.

Using a pain scale of 0 to 10, participants self-reported that green light exposure resulted in a 60% average reduction in their headache pain, from 8 to 3.2.

Green light also shortened the duration of headaches, and improved participants' ability to fall and stay asleep, perform chores, exercise, and work. None of the patients reported any side effects.

"In this trial, we treated green light as a drug," Ibrahim said. "It's not any green light. It has to be the right intensity, the right frequency, the right exposure time and the right exposure methods. Just like with medications, there is a sweet spot with light."

Participants were given green light emitting diodes – LED lights – with instructions to follow while completing the study at home. They were also allowed to continue current migraine therapies and to initiate new treatments if directed by their physicians.

"One of the ways we measured participant satisfaction was, when we enrolled people, we told them they would have to return the light at the end of the study. But when it came to the end of the study, we offered them the option to keep the light, and 28 out of the 29 decided to keep the light," said Ibrahim.

Most of the study participants - 86% of episodic migraine patients and 63% of chronic migraine patients - reported the number of headache days per month was reduced by at least 50 percent. Episodic migraine is characterized by up to 14 headache days per month, while chronic migraine is 15 or more headache days per month.

Ibrahim and co-author Amol Patwardhan, MD, have been studying the effects of green light therapy for several years.

"Despite recent advances, the treatment of migraine headaches is still a challenge," said Patwardhan, an associate professor and the vice chair of research in the Department of Anesthesiology. "The use of a nonpharmacological therapy such as green light can be of tremendous help to a variety of patients that either do not want to be on medications or do not respond to them. The beauty of this approach is the lack of associated side effects."

Dr. Ibrahim has been contacted by doctors in Europe, Africa and Asia, asking for information about green light therapy for their own patients.

"As you can imagine, LED light is cheap," Ibrahim said. "Especially in places where resources are not that available and people have to think twice before they spend their money, when you offer something affordable, it's a good option to try."

The study findings were published online in Cephalalgia, the journal of the International Headache Society.

A 2016 study by researchers at Beth Israel Deaconess Medical Center in Boston also found that green light therapy reduced headache severity in migraine sufferers. Patients in that study were exposed to different intensities of blue, green, amber and red light. Most patients said their migraines got worse when exposed to white, blue or amber light, while green light was found to reduce pain in 20 percent of patients.

About a billion people worldwide suffer from headaches caused by migraines, which affect three times as many women as men. Migraine affects more than 37 million people in the United States, according to the American Migraine Foundation. In addition to headache pain and nausea, migraine can cause vomiting, blurriness or visual disturbances, and sensitivity to light and sound. About half of people living with migraine are undiagnosed.

‘Golden Era’ for Migraine Therapy Not Providing Relief

By Pat Anson, PNN Editor

In recent years there have been many advances in treating and preventing migraine – what some have called a “treatment revolution” in migraine therapy. New oral and injectable drugs block a key protein released during migraine attacks, and a novel smartphone-controlled device uses neuromodulation to help ease migraine pain.

But for many migraine sufferers, the increasingly crowded field in migraine therapy isn’t translating into pain relief or improved quality of life. Many are reluctant to seek treatment or take medication, and feel stigma about having the disease, according to two new studies.

“We are in a golden era for migraine care with the introduction of new therapeutic options for both the acute and preventive treatment of the disease, but if we don't address the need for better education, less stigma and improved access to care, we are falling short," said Eric Pearlman, MD, a senior medical director at Eli Lilly.

A survey released by the National Headache Foundation in recognition of Migraine and Headache Awareness Month found that less than a third (29%) of people with migraine feel that their disease is under control. The online survey of over 1,000 men and women diagnosed with migraine was funded by Biohaven Pharmaceutical.

Many respondents are concerned about side effects from the medications they take, such as brain fog, fatigue and sleepiness. Almost half of respondents (47%) between the ages of 18-59 say side effects have interfered with their ability to go to school or work. Nearly as many (46%) feel anxious about taking medication.

And despite the plethora of new choices available in migraine therapies, nearly two-thirds (65%) of migraine sufferers are still using an old medication -- triptans -- as a treatment for migraine pain.

"We must strive to understand and educate about the impact of this disease on not only physical well-being; but also, emotional and mental health," said Mary Franklin, executive director of National Headache Foundation. "Every person living with migraine has a different experience and we want all to feel confident in their treatment choices; but also know that there are others who understand the real impact of the disease."

The survey asked migraine sufferers about the emotional and mental burden of the disease, and the impact it has on daily life.

• 77% said they were not able to do the things they wanted to because of migraine attacks 

• 54% feared they were a burden to family, friends and colleagues

• 53% say they modified career plans due to migraine

• 42% were unable to exercise or engage in physical activity

• 37% feel less productive at work or school

• 28% feel less able to take care of their children

• 25% avoid sexual intimacy

The vast majority of respondents (93%) feel misunderstood and that those who don't suffer from migraine don't understand the severity of their disease.

OVERCOME Study

Results from the Biohaven survey were echoed in a large new study of more than 21,000 people living with migraine, which found that less than 30 percent are taking a recommended prescription medication.

"For millions of people living with migraine, the journey to an appropriate treatment program is fraught with gaps," said Susan Hutchinson, MD, scientific advisor to the OVERCOME study. "There are a variety of reasons at play, but it begins with the fact that many may not realize what they are experiencing is a migraine and not just 'another bad headache.'”

The OVERCOME (Observational Survey of the Epidemiology, Treatment and Care of Migraine) study was funded by Eli Lilly. It sought to assess the impact of new treatment options and whether migraine sufferers completed three critical steps in migraine management:

1. Actively sought care with a healthcare professional

2. Received a migraine diagnosis

3. Took a recommended prescription medication

Less than two-thirds (63%) of those who may benefit from acute migraine medication sought treatment from a healthcare provider. Of those, 75% were diagnosed with migraine. Among the diagnosed population, only 59% percent took a recommended drug. Overall, only 28 percent completed all three steps to appropriate care.

The results weren’t much better for OVERCOME respondents who may benefit from a migraine prevention drug. A little over two-thirds (69%) sought care and 79% received a migraine diagnosis. Of those who sought care and received a diagnosis, only 28% wound up taking a preventive medication for migraine. Overall, only 15 percent of this population completed all three steps to appropriate care.

Some migraine sufferers only seek treatment when their pain become unbearable. About 10% of respondents sought care in an emergency room or urgent care clinic setting, where they are less likely to receive an accurate diagnosis or take a recommended medication. 

"Even in light of recent new treatment options in the field of migraine, we still face an uphill battle as too many continue to be underserved," said Robert Shapiro, MD, a scientific advisor to the OVERCOME study. "An important aspect of migraine care that is truly diminished and may contribute to these findings is the stigma felt by many living with the disease. A person's reluctance to seek care or take medication for their migraine can be rooted in the fear of how a friend, employer, or even a loved one may view them for doing so."

Migraine affects about a billion people worldwide and 36 million adults in the United States, according to the American Migraine Foundation. In addition to headache pain, migraine can also cause nausea, vomiting, blurriness or visual disturbances, and sensitivity to light and sound. The World Health Organization classifies migraine as one of the 10 most disabling medical illnesses.

Lessons Learned from 20 Years of Chronic Pain

By Mia Maysack, PNN Columnist

This year, I'm honoring the 20th anniversary of how long my head has been hurting.

I was fortunate to learn at a young age that we're not invincible. Slipping into a coma, two brain surgeries, and years of rehab resulting from a near death experience with bacterial meningitis has a way of humbling a person.  

Healing isn't linear and has thus far proved to be a lifelong process for me. I've got no reason to believe I've reached an apex of wellness.   

Simply put, the journey has had many ups and downs. Relationships with others were shattered because my own life was in pieces. I didn't know how to effectively communicate with others about my health, because I wasn't fully aware about my own limits. This ultimately overtook my career goals and almost claimed my sanity.

Maybe I lost my mind long ago. If you see it, let me know!

Of course, it hurts to bid adieu to people I still care about, but I've had to evolve to put my own self-care first. Drama isn't a thing I'm physically well enough to take on, as it greatly depletes me. I've had to cultivate avoidance of it by all means necessary.  

I've grown to no longer feel a desire to excuse or justify the accommodations I need. And I know that anyone who doesn't honor what my personal needs are couldn't be what's best for me. So though distance can hurt, it isn't always a loss. 

Anything that's forced -- be it with another person or within our own selves – is a signal to me. An instant message from somewhere deep. It’s an inner wisdom we all carry, always there to be heard and listened to. 

We may not know what exactly is happening in regards to our pain or illness, nor comprehend why it exists, where it came from or what we can do about it. But when we slow down to the point of fully acknowledging ourselves lovingly, there's power, freedom and a sense of peace in that.  

Of course, it's not just about us. How we conduct ourselves has an impact on every one and thing around us. If nothing else, this pandemic has undeniably demonstrated that much. Nothing about life, especially living under strenuous circumstances, is easy. It requires us to keep our heads up and continue growing.  

This requires many things -- diet, sleep, exercise and lifestyle balance, to name a few. One of the more recent revolutions of mine has been that I do not need to follow suit on what anybody else -- providers included -- thinks is best for me. It's a team effort and any form of support is vital and definitely a blessing. But any person or thing outside of ourselves can only take us so far. Our loved ones, friends and our healthcare teams need open communication about that.  

Not everyone has a cure or fix, but our circumstances can improve with a more helpful attitude. We can tune in and reflect on what aligns with where we're at on the path of figuring all this out – and then proceed according to that. We're still just as valuable as we've always been, just in different ways. 

A Greater Purpose

Until I chose to no longer allow this to just happen to me but affirmed myself in active boss mode over what repeatedly tests my will to live, there's a co-existence that's possible -- an intimacy with yourself, a language spoken within, that's solely between you and your vessel. 

It's not glamorous. It’s isolating and lonely. But the truth is that we're not alone, and your reading of this column thus far is a demonstration of that.

What I needed in life didn't exist, so I dedicated myself to creating ways to keep the parts of myself alive that matter most. I'm devoted to never giving up because there's a greater purpose to be found in our challenges. 

There are always new breakthroughs. We cannot know if something could help if we don't keep our minds and hearts open to it by coming to terms with our losses. Without a doubt, that’s the hardest thing I've ever done in my life, other than survive every day.

Addressing tough moments doesn't mean that's the end of them. But letting these conditions dictate the overall quality of my days became intolerable and unacceptable. Pain is a part of us – but not who we are. I’ve evolved to accept the past for what it was, the present as it is, and the future for whatever it'll be.  

Partake in self-pity moments when you must, but don't unpack and live there. It is okay, normal and natural to breakdown or even completely fall apart. Start over. Life is always evolving and it requires the same from us.

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.

Nerivio: What’s All the Buzz About?

By Mia Maysack, PNN Columnist

If you have migraines and are open to more holistic approaches to treating them, I’d like to share my experience with Nerivio. It’s the first smartphone-controlled neuromodulation device for the treatment of migraine, with or without aura. I was provided one of the devices, which is worn on the arm, at no cost by the manufacturer, Theranica Bio-Electronics.

Nerivio requires a prescription from a doctor. I was able to be seen via telemedicine through Cove for my appointment, which was convenient. A script was written for 12 treatments, which are thought to be most beneficial within the first 30 minutes of experiencing aura or the onset of pain.

Given that my head hurts 24/7/365, I was hesitant to even try Nerivio, but ultimately decided it was worthwhile due to the low risk of side effects. I've tried different types of neuromodulation devices before, without success, and went into this with an open mind and minimal expectations.

Nerivio didn't take any of my discomfort away, but it did cultivate a decent enough distraction. Despite my blaring head pain, I love loud music. I realize that could seem odd, but I figure since it hurts anyway, turn it up! Anything to switch up the frequency of this migraine that's stuck on repeat. 

I view Nerivio similarly. You have to chill out for the treatments, which are 45 minutes in length. Though it is possible to go about daily activities during treatments, I found it more comfortable not to. I'd take deep breaths and visualize the armband just like music, disrupting the head pain and transmitting restorative waves.   

Much like the beloved 12" subwoofer in Ophelia (my car), I controlled the volume, using my smartphone to dictate the intensity of Nerivio.

When it’s on, Nerivio delivers small electric impulses into the upper arm that disrupt pain signals in the brain. I first compared the feeling of neuromodulation to that of a tingle or itch, but after becoming more familiar, I'd label it as vibrational. It doesn't hurt, and the sensation is a welcome change of pace for anyone experiencing head pain 

It's important to remember there is a weak current of electricity, so fingers shouldn't be directly placed on the device when it's on, nor should it be used in any place other than your arm. 

The device costs about $100. That can be a significant amount of money, especially for those of us unable to maintain any sense of normalcy regarding employment or income. But I’ve paid out of pocket far more than that, regularly, for co-pays and uncovered treatments, not to mention pills that demanded Benjamin Franklin’s face for not even a week’s worth of treatment.   

What I appreciate about Nerivio is that it’s something I can do on my own. I altered the arms I used it on and always incorporated relaxation with my experiences to whatever extent I could.  It worked nicely in conjunction with mindfulness breaks, as well as first thing upon waking up or last thing before bed. 

IMAGES COURTESY OF THERANICA

It’s also relieving to literally be holding the “power” in the palm of my hands. If there’s a need to halt a session, there is a pause button. Although I didn’t get around to utilizing it, Nerivio also has a feature that assists in promoting guided imagery and meditation as a further enhancement.   

For each treatment, all that’s necessary is to hit the power button on the armband and ensure it has synced up to your device. Within the first few moments when starting, a questionnaire pops up on the screen asking how you’re feeling. This acts similarly to a virtual diary to track symptoms and hopefully improvement. This step isn’t necessary, although never a bad idea to monitor or check in as to where you’re at.

All in all, I’d have to say if you’re curious enough and able to, go ahead and give Nerivio a try.  I believe it could be beneficial for other migraine conditions not as complex as mine.  

I haven’t been paid or endorsed at all for this review and offer these words solely as a resource for those who are considering it.  Feel free to follow up with questions, as I’m honored to help navigate the Nerivio process with you in any way I am able.

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.

Take Your Shot (Or Not)

By Mia Maysack, PNN Columnist

Modern day pandemics aside, we’re fortunate to live in an age when there are continual advances in medicine. More forward momentum in the pursuit of migraine and headache treatment has occurred within the past two years than we’ve seen in decades. New injectable drugs help prevent migraine and others promise relief during migraine attacks.

Injections for migraine are not new to me. I received about 30 Botox shots every 90 days for longer than most people even had their headaches. Let's just say, it was for an extraordinarily long time.

A few years ago, I was awaiting another round of shots to the head and noticed my tummy was in knots for some reason. The nurse came in and told me they were trying a new brand of Botox, which basically means they found a cheaper version. This meant you sometimes get a batch of the medicine you've become accustomed to and sometimes it was a mystery combo, mixed with “similar” fillers containing the "same" active ingredient of botulinum toxin.

At the last session, I'd gone in for my regularly scheduled shots and got one of the worst migraines ever instantaneously. This was out of the normal for me and it led to almost a yearlong cluster that forced me to pause my med school pursuit and nursing career. I still have yet to bounce back from it.

They claimed I could have possibly received a “bad batch,” which I accepted due to how many times I've gotten this treatment with little to no adverse effects. Things cannot always be perfect, right? 

I wonder, however, still living with the repercussions to this day, if it was an adverse or allergic reaction to something.

Adding to my doubts is that I had been waiting on the doctor for over 45 minutes. Don't mind me! I don’t have anything else happening in my life, not like they even bothered asking. 

While waiting, I looked over at all the syringes full of who-knows-what and realized it just didn't align with me, my purpose or path anymore. 

I have nothing but good things to say about Botox, as it sincerely helped me for many years. It's one of the only things that ever has. But as we all must understand, no one knows the long-term repercussions of consistent use of any treatment option. 

Honoring the fact that we would all do just about anything to lessen our pain, I willingly took well over a thousand shots out of desperation for even a small fraction of relief. But what it often boils down to is trading one problem for another, even without being aware of it at the time.

Regarding a lot of the options out today, we are the guinea pigs and lab rats. There's no way of knowing how they could interfere with our well-being over time.

Earlier that same week, I was at a different appointment and they were inquiring about medications I take. By then, I had phased myself off nearly everything and Botox was the last traditional path I hung onto.

I told the nurse that, she replied and I quote: "That's probably for the best, I cannot tell you how many have come through with liver issues and kidney failure from their exposure to consistent prescription drug use." 

I’m proud to say my approach to healthcare is entirely holistic these days. Most providers are not extensively trained on how to treat pain, that's why they call it practicing medicine. They're only human as well and everyone is different -- thereby resulting in different outcomes for everybody -- hence the one-size-fits-all approach not working.

I share my Botox experience not to suggest anything or to instill fear, but to show that we don't always know what we are doing and it's no one else's responsibility to inform us. It is your body and your life. I urge you all to take control and remain curious, ask important questions, and don't eat everything that's fed to you. 

Unfortunately, we are living in a time where our best interest comes only after a check has been written. But by that point, as in my case, the damage may have already been done. I left that office and don't plan on ever going back.

Remember that every patient cured is a customer lost. Look out for and protect yourself!

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.

Study Finds ‘Good Evidence’ Acupuncture Can Treat Migraine

By Pat Anson, PNN Editor

Recent advances in treating and preventing migraines with new drugs have created a “treatment revolution” in migraine therapy.  But a more ancient technique may work even better, according to a small study recently published in the British Medical Journal (BMJ).  

Researchers in China say acupuncture was up to four times more effective than a non-steroidal anti-inflammatory drug (NSAID) in reducing attacks of episodic migraine without aura.

The study involved 147 migraine patients treated at seven hospitals in China from 2016 to 2018. The patients were divided into three groups; with one group getting 20 sessions of manual acupuncture, another group getting sham (fake) acupuncture, and the third group getting “usual care” that included use of the NSAID diclofenac.  

By the end of the study, patients who received acupuncture were having 2.3 fewer migraine attacks a month, compared to 0.4 and 1.6 fewer attacks for the usual care and sham groups, respectively. 

“In this study in acupuncture naive patients with episodic migraine without aura, 20 sessions of manual acupuncture produced a relatively long lasting reduction in migraine days and migraine attacks compared with sham acupuncture and usual care,” researchers reported. “Overall, the therapeutic effects in the manual acupuncture group occurred earlier, were larger, and might last longer.”

‘Useful Additional Tool’

According to one migraine expert, the study shows that acupuncture can be a “useful additional tool” in migraine therapy.

"We now have good evidence that acupuncture is an effective treatment for episodic migraine," writes Heather Angus-Leppan, MD, a neurologist at the Royal Free London NHS Foundation Trust, in a BMJ editorial. "(The study) helps to move acupuncture from having an unproven status in complementary medicine to an acceptable evidence-based treatment."

The study drew a mixed reaction from readers in The Daily Mail.

“Great if it works for you, but it did absolutely nothing for me except wasted money I could Ill afford,” one poster wrote.

“Unfortunately, never worked for me. But good for those who it did. Migraines are a debilitating thing to have,” said another.

“I suffered weekly migraines for decades before trying acupuncture, given by a lady who trained for years in China. After the first session the migraines stopped completely for around 20 years. When they recurred, I tried acupuncture again, from the same lady, and it had no effect at all. I'd still say it's really worth giving it a go,” wrote another poster.

“I had severe and frequent migraines as a teenager - the doctors tried everything from beta blockers to a dairy free diet. Acupuncture was the only thing that really worked - it broke the cycle and my migraines became less severe and more infrequent,” another poster said. “Now I rarely have a migraine at all and if I get a headache using pressure points really helps. It worked for me but may not work for everyone.”

Migraine affects about a billion people worldwide and 36 million adults in the United States, according to the American Migraine Foundation. In addition to headache pain, migraine can also cause nausea, vomiting, blurriness or visual disturbances, and sensitivity to light and sound.

As many as 3 million Americans receive acupuncture treatments, most often for relief of chronic pain. While there is little consensus in the medical community about the effectiveness of acupuncture, the Centers for Medicare & Medicaid Services (CMS) recently said it would start covering acupuncture for Medicare patients with chronic low back pain.

Do Smartphones Cause More Headaches?

By Pat Anson, PNN Editor

People with headaches who use smartphones are more likely to use more pain medication, but get less relief from the drugs, according to a new study conducted in India.

Researchers surveyed 400 people who suffer from a primary headache condition, which includes migraine, tension headache and other types of headaches, asking them about their smartphone and medication use.

The smartphone users were more likely to take pain-relieving drugs for their headaches than non-users, with 96% of smartphone users taking the drugs compared to 81% of non-users. Smartphone users took an average of eight pills per month compared to five pills per month for non-users.

Smartphone users also reported less relief from pain medication, with 84% gaining moderate or complete relief of headache pain compared to 94% of non-users. The study findings were published in the journal Neurology Clinical Practice.

"While these results need to be confirmed with larger and more rigorous studies, the findings are concerning, as smartphone use is growing rapidly and has been linked to a number of symptoms, with headache being the most common," said lead author Deepti Vibha, DM, of All India Institute of Medical Sciences.

The study has limitations. It only examined people at one point in time and did not follow them over an extended period. It also relied on people to self-report their symptoms and use of pain medication.

While the study does not prove that smartphone use causes headaches or greater use of pain medication, it does show an association.

“There is a great deal of speculation among the lay population regarding the effect of computers and mobile phones on ailments such as headaches and neck pain. However, although there are anecdotal stories suggesting a link between technology use and pain, there is little evidence of either a definitive relationship or data absolving mobile phones or computers from a link to recurrent pain,” wrote Heidi Moawad, MD, of Case Western Reserve University, in an editorial accompanying the study.

“Smartphone users may rely on the devices for many hours per day -- while on the go, resting, or working -- which puts a strain on the eyes, neck, and back. As people are becoming more dependent on these devices, it would be worthwhile to know whether using smartphones could lead to health problems.”

A 2017 study speculated that high energy visible (HEV) light – also known as blue light – emitted by smartphones, laptops, desktop computers and other digital devices could contribute to headaches by causing eye strain. Blue light has a very short wavelength that penetrates deep into the eye.

A nationwide survey of nearly 10,000 adults by The Vision Council found that about a third had symptoms of digital eye strain, including neck and shoulder pain, headache, blurred vision and dry eyes.

More information about blue light can be found at BlueLightExposed.com.

FDA Approves First Intravenous Preventive Treatment for Migraine

By Pat Anson, PNN Editor

The U.S. Food and Drug Administration has approved the first intravenous treatment for the prevention of migraine in adults, adding to an increasingly crowded field in new migraine drugs.

Lundbeck, a Danish pharmaceutical company, said Vyepti (eptinezumab-jjmr) would be available in April 2020. The recommended dose is 100 mg every 3 months; although some patients may benefit from a dose of 300 mg. Price details were not released.

Vyepti is a humanized monoclonal antibody that prevents migraines by blocking a key protein — calcitonin gene-related peptides (CGRP) -- from binding to nerve receptors in the brain.

Since 2018, the FDA has approved three injectable CGRP inhibitors for migraine prevention and recently approved the first oral tablet for migraine treatment. Vypeti is the first CGRP blocker to be administered intravenously.

“With the approval of Vyepti, I am pleased that we are now able to offer a new IV therapy that achieves the key treatment goal of preventing migraine over time while also delivering on the need for earlier onset of efficacy,” Dr. Deborah Dunsire, President and CEO of Lundbeck, said in a statement.

The efficacy and safety of Vyepti was demonstrated in two phase III clinical trials (PROMISE-1 in episodic migraine and PROMISE-2 in chronic migraine) involving over 1,700 patients. Treatment benefit was observed for both doses of Vyepti as early as one day after infusion, and there was a sustained reduction of migraines through the second dose.

“The PROMISE-2 data showed that many patients can achieve reduction in migraine days of at least 75 percent and experience a sustained migraine improvement through 6 months, which is clinically meaningful to both physicians and patients,” said Dr. Peter Goadsby, a professor of neurology at King’s College, London and the University of California, San Francisco. “Vyepti is a valuable addition for the treatment of migraine, which can help reduce the burden of this serious disease.”

Patients were allowed to continue using other migraine or headache medications during the trials. About 2 percent of patients treated with Vyepti discontinued treatment due to adverse reactions, such as an upper respiratory infection and hypersensitivity that causes facial flushing and rash.

Lundbeck has submitted an application for market authorization of Vyepti in Canada and plans to file in the European Union during 2020, followed by the submission of drug applications in other countries around the world, including China and Japan.

Migraine affects about a billion people worldwide and 36 million adults in the United States, according to the American Migraine Foundation. It affects three times as many women as men. In addition to headache pain, migraine can also cause nausea, vomiting, blurriness or visual disturbances, and sensitivity to light and sound.

Headache on the Hill: How Advocacy Empowers Patients

By Mia Maysack, PNN Columnist

Headache on the Hill is an annual lobbying event for migraine and cluster headache patients and advocates that takes place in Washington, D.C. I was fortunate to participate this past week and for the last three years, and look forward to participating in as many more as I am able.  

Headache on the Hill (HOH) is organized by the Alliance for Headache Disorders Advocacy and there are multiple other coalitions, organizations, foundations and institutions that make up the partnering network. 

Hundreds of patients, caregivers and medical professionals join forces in venturing to the Hill together, visiting congressional offices (there were 250 meetings this year, the most ever!) to present ever changing “asks” for more research and funding.

My first year at HOH was surreal. I hadn't realized exactly what I'd gotten myself into or the extent it would alter the course of my life. I found a great deal of comfort, as well as empowerment, from the realization that our legislators are much like doctors in the sense that they essentially work for us and we're supposed to be a team.  

The second time around, I shifted my approach from requesting everything right off the bat to inquiring about their knowledge: “Do you or does anyone you know live with headache or migraine?"

Many do have a connection, which isn't surprising, given there are 47 million Americans living with migraines and cluster headaches.  Bonding over facts is a great way to raise awareness and build rapport.  

They say the third time is a charm and, in this instance, I’d have to agree. Not only have I become stronger and more affirmed in using my voice, but one could even say I've grown darn right ballsy!

My two-decade old traumatic brain injury has hurt every day since it happened, so that along with the fact I know I'm not alone in this experience, is what leads me back to these gatherings.

Our agenda was to address the emergent shortage of specialists and astronomical need for more pain management education prior to a provider going into practice. 

As of now, the United States has less than one-sixth the number of headache doctors it needs.  There are 1.2 physicians per 100,000 people with migraine. And by 2032, we’ll be facing a shortage of up to 122,000 doctors and specialists.

As with other chronic pain conditions, when acute migraine and headache attacks are not treated properly or go untreated, they can become chronic and symptoms worsen. Improper pain management can lead to an understandable feeling of desperation, which could play out as people attempt to self-medicate. That has potential to land us in the exact sort of drug crises we’re facing right now.      

We know migraine is the second leading cause of global disability (behind low back pain), yet it has received little funding.  According to the World Health Organization, migraine results in more lost years of healthy life in the U.S. than epilepsy, multiple sclerosis (MS), tuberculosis and ovarian cancer combined.  

Head-related pain often doesn’t respond well to opioid medication, but despite the risk of complications, opioids are still being used, primarily in emergency room scenarios. 

In a more general sense, 50 million Americans have chronic pain, of which 20 million, myself included, experience “high impact” chronic pain. I don't know about you, but the fact so many of us are living without an adequate care plan or any relief whatsoever, is about as crucial as it gets. Hence the importance of showing up at HOH to demonstrate our commitment and the seriousness pertaining to these issues.   

The travel, excitement, boat load of walking, and emotional components take a very real toll. It's not uncommon after trips like this that we all crash. Some require weeks to months just to get back to baseline, but what's most remarkable is that we continue to do it all over again. 

When navigating the maze of those congressional halls and seeing, supporting, encouraging and taking care of one another, it is times like those that build me up, give me strength and fuel my fire to continue on with the work long after we've left Washington. 

Being an advocate is no longer something I do -- it is a part of who I am. 

Mia Maysack lives with chronic migraine, cluster headaches 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.