A Virtual Headache on the Hill

By Mia Maysack, PNN Columnist

Last week I was fortunate to attend the 14th annual “Headache on the Hill,” a lobbying event held by the Alliance for Headache Disorders Advocacy (AHDA).  We had the largest turnout ever in participants and number of meetings, although it was a far different affair than previous ones.  

Due to the pandemic and Covid precautions, visits to congressional offices that normally would've taken place in person on Capitol Hill were conducted online via Zoom -- which was an adjustment I was grateful to make.

As a result of doing things virtually, it gave people who ordinarily may not be well enough to attend an opportunity to do so. I feel this is a more inclusive approach and should perhaps remain an option even after this pandemic settles. 

Traveling is extraordinarily strenuous on my health and always requires an extensive amount of recovery time. So the opportunity to lie down in between meetings and have the comforts of home around me -- such as soft lighting and blackout curtains -- made all the difference and helped make getting through the day possible. It also ensures I won't be confronted by weeks on end of flare ups and pain cycles. 

I am proud to represent the state of Wisconsin as a volunteer patient advocate, human rights activist and someone who has lived with intractable head pain to some extent each and every day for almost 21 years as a direct result of a traumatic brain injury.  

Given that there are around 40 million people in the U.S. alone who live with migraine disease, the odds are that you either experience it yourself or know of someone who does.  For those who are privileged not to have migraine, Covid-19 has given you a small taste of how we often exist:  shut in and unable to see loved ones, go to work or do things we enjoy. 

I live with both migraine disease and cluster headaches, which are called “suicide headaches” for good reason.  There's no limit to the chaos, interruption, inconvenience and discomfort these conditions have caused in my life, requiring my full time attention just to manage the symptoms.

The difficult experiences I and countless others have faced in seeking, finding and attempting different forms of treatment is why I continue to advocate -- even when I don't feel up to it. Migraine and other forms of head pain are at the top of the list regarding burden and disability, yet we've been severely limited with treatment options that usually mask the symptoms temporarily, as opposed to addressing the root cause.   

We've seen progress in recent years with more injectable treatment options, after being limited for decades to oral triptans. But insurance for the shots can be a nightmare (if you're fortunate enough to have insurance) and I received what was labeled as a "bad batch" of shots that gave me side effects I am still living with today.   

What We Asked For

Our medical system is set up in such a way that we’re able to receive a prescription relatively easily, but alternative tools such as water therapy, massage, oxygen and mindfulness meditation aren't seriously considered, let alone covered. This is a very real problem.

It also makes no sense that migraine conditions are some of the least funded research areas for the National Institutes of Health. Our “asks” during Headache on the Hill were to devote more funding toward the research and treatment of migraine. Currently there's only $20 million or so being spent. We’re requesting $50 Million designated specifically for NIH research on migraine and headache disorders.  

Additional funding could also help incentivize more providers to obtain neurology-related medical degrees, as there is a severe shortage and need for more headache specialists. More funding is needed to develop new treatments, help cultivate data on the benefits of more holistic approaches, and assist in providing more dignity to those of us who feel invisible and shunned by a system that's supposed to be on our side.  

Furthermore, and perhaps even more disgracefully, hundreds of thousands of our military veterans suffer from traumatic brain injuries as a result of being exposed to explosions and toxic open burn pits.  We asked for another $25 million to double the number of specialized treatment sites that the VA has for veterans with headache disorders. 

These are the individuals who ensure that we possess and maintain the liberties of this country and they deserve the absolute best we have to offer. I know that we can do better on all of these issues and we must. It's time to urge our representatives to follow through and do the right thing.  

You can help by visiting the AHDA website and following the prompts for sending an email to your representatives and senators.  Urge them to fully fund the VA’s Headache Disorders Centers. 

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. 

New European Guideline Says Opioids ‘Do Not Work’ for Many Types of Chronic Pain

By Pat Anson, PNN Editor

Calling opioid medication a “two edged sword,” the European Pain Federation (EFIC) has released new guidelines that strongly recommend against using opioids to treat fibromyalgia, low back pain, migraine, irritable bowel syndrome and other types of chronic non-cancer pain.

“The new recommendations advise that opioids should not be prescribed for people with chronic primary pain as they do not work for these patients,” the EFIC said in a statement.

However, the guideline states that low doses of opioids may be suitable for treating “secondary pain syndromes” caused by surgery, trauma, disease or nerve damage, but only after exercise, meditation and other non-pharmacological therapies are tried first.

“Opioids should neither be embraced as a cure‐all nor shunned as universally dangerous and inappropriate for chronic noncancer pain. They should only be used for some selected chronic noncancer pain syndromes if established non‐pharmacological and pharmacological treatment options have failed,” the guideline states. “In this context alone, opioid therapy can be a useful tool in achieving and maintaining an optimal level of pain control in some patients.”

Opioid pain relievers are not as widely used in Europe as they are in the United States or Canada. The EFIC said it was trying to “allay concerns over an opioid crisis” developing in Europe, as it has in North America.       

“As the leading pain science organisation in Europe, it is crucial that EFIC sets the agenda on issues such as opioids, where there are growing societal concerns. These recommendations clarify what role opioids should play in chronic pain management,” EFIC President Brona Fullen said in a statement.

The guideline’s lead author, Professor Winfried Häuser, said he and his colleagues tried to strike a middle ground on the use of opioids.

“The debate on opioid-prescribing for chronic non-cancer pain has become polarized: opioids are either seen as a dangerous risk for all patients, leading to addiction and deaths, or they are promoted as most potent pain killers for any type of pain,” said Häuser, who is an internal medicine specialist in Germany.

“Opioids are still important in the management of chronic non-cancer pain – but only in some selected chronic pain syndromes and only if established non-pharmacological and non-opioids analgesics have failed or are not tolerated.”

PROP Consulted for European Guideline

The guideline was developed by a 17-member task force composed of European experts in pain management, including 9 delegates selected by EFIC’s board “who advocate and who are critical with the use of opioids.” Only one delegate from Pain Alliance Europe represented patients.

The recommendations developed by the task force were reviewed by five outside experts, including Drs. Jane Ballantyne and Mark Sullivan, who belong to Physicians for Responsible Opioid Prescribing (PROP), an anti-opioid activist group in the U.S.  Ballantyne is PROP’s President, while Sullivan is a PROP board member. Several changes suggested by the outside experts were adopted.

Coincidentally, Ballantyne, Sullivan and three other PROP board members were involved in the drafting of the opioid guideline released in 2016 by the U.S. Centers for Disease Control and Prevention. That controversial guideline is now being rewritten by the CDC after voluminous complaints from patients and doctors that the recommendations led to forced tapering, withdrawal, uncontrolled pain and suicides.

Sullivan and two other PROP board members were also involved in drafting Canada’s 2017 opioid guideline, which was modeled after the CDC’s and provoked similar complaints from Canadian pain patients.

90 MME Recommended Limit

The CDC and Canadian opioid guidelines appear to have been used as resources by the EFIC task force, which adopted many of the same recommendations, even while acknowledging the low quality of evidence used to support them.   

One recommendation is straight out of the CDC guideline, advising European doctors to “start low and go slow.” Prescribers are urged to start patients on low doses of 50 morphine milligram equivalents (MME) or less a day and to avoid increasing the dosage above 90 MME/day.

One significant difference with the North American guidelines is that the EFIC recommends that opioids not be prescribed for fibromyalgia, migraines and other chronic “primary pain” conditions for which there is no known cause – suggesting those disorders have an emotional or psychological element that will lead to opioid abuse.

“Prescription of high doses of opioids to patients with primary pain syndromes might have been a factor driving the opioid crisis in North America,” the EFIC guideline warns.

“This was further compounded by patient characteristics that included physical and psychological trauma, social disadvantage and hopelessness that served as a trigger for reports of pain intensity prompting prescriptions of more opioids.”

Secondary pain conditions for which opioids “can be considered“ include multiple sclerosis, stroke, restless leg syndrome, Parkinson’s disease, rheumatoid arthritis, phantom limb pain, non-diabetic neuropathy, spinal cord injuries and Complex Regional Pain Syndrome (CRPS). 

Unlike the North American guidelines, the EFIC acknowledges that there are physical and genetic differences between patients. Some patients who are rapid metabolizers “might require higher dosages of opioids than the ones recommended by the guidelines.“

EFIC GRAPHIC

The EFIC also warns that its guideline should not be used to justify abruptly tapering or discontinuing opioids for anyone already prescribed at higher dosages. The recommendations are also not intended for the management of short-term acute pain, sickle cell disease or end-of-life care.

Medical Cannabis Linked to Rebound Headaches

By Pat Anson, PNN Editor

Medication overuse headache, also known as “rebound” headache, is a common problem for people who frequently use pain medication to relieve headaches and migraine.

According to the American Migraine Foundation, rebound headaches can be triggered by a wide assortment of analgesics, from aspirin and triptans to acetaminophen and opioids. Even caffeine can cause a rebound headache if you consume more than 200mg a day – about two cups of coffee.     

So perhaps it’s not surprising that medical cannabis is also associated with medication overuse headache, according to a preliminary study by researchers at Stanford University School of Medicine.

“Many people with chronic migraine are already self-medicating with cannabis, and there is some evidence that cannabis can help treat other types of chronic pain,” said study author Niushen Zhang, MD, a neurologist who is director of Stanford’s Headache Fellowship Program.

“However, we found that people who were using cannabis had significantly increased odds of also having medication overuse headache, or rebound headache, compared to people who were not using cannabis.”

Zhang and her colleagues looked at the medical records of 368 people who had chronic migraine -- which is 15 or more headache days per month. Less than half were using medical cannabis

Researchers found the cannabis users were six times more likely to have rebound headaches than those who did not use cannabis. People who used cannabis were also more likely to take opioids.  Previous research has found that opioids and cannabis can both influence the part of the brain called the periaqueductal gray, which has been linked to migraine.

Zhang’s study will be presented at the American Academy of Neurology’s annual meeting next month.

Medical cannabis has become a trendy alternative to pharmaceuticals for treating migraine, with research showing that both inhaled and ingested cannabis can reduce migraine pain. 

A recent study of nearly 10,000 people in the U.S. and Canada who used a migraine tracking app found that 82 percent who used cannabis believed it was an effective pain reliever.    

A 2017 study conducted in Israel found that combining THC and CBD in an oral dose was just as effective in treating migraine pain as amitriptyline – a tricyclic antidepressant commonly prescribed for migraine.

And a 2016 study at the University of Colorado found that cannabis significantly reduced the number of migraine headaches. Inhalation appeared to provide the fastest results, while edible cannabis took longer to provide pain relief.

About a billion people worldwide suffer from migraine headaches, 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.

Study Finds Regular Exercise Reduces Migraine Triggers

By Pat Anson, PNN Editor

Two-and-a-half hours of moderate to vigorous exercise a week can significantly reduce migraine triggers like stress, depression and poor sleep, according to a new survey that found more than two-thirds of migraine sufferers do not get enough exercise.

“Migraine is a disabling condition that affects millions of people in the United States, and yet regular exercise may be an effective way to reduce the frequency and intensity of some migraines,” says lead author Mason Dyess, DO, a Senior Fellow at the University of Washington School of Medicine.

“Exercise releases natural pain killers called endorphins, helps people sleep better and reduces stress. But if people with migraine are not exercising, they may not be reaping these benefits.”

The survey involved 4,647 people diagnosed with migraine. About three-fourths of participants had chronic migraine, meaning 15 or more migraines a month. The others had episodic migraine, or up to 14 a month.

Participants completed a questionnaire about their migraines, sleep, depression, stress, anxiety and the amount of exercise they get each week.

Researchers then divided them into five groups based on their level of exercise: those who did not exercise; people who exercised up to 30 minutes per week; those who exercised 31 to 90 minutes; people who exercised 91 to 150 minutes; and participants who exercised more than 150 minutes per week.

Types of exercise that qualified as moderate to vigorous included jogging, very brisk walking, playing a sport, heavy cleaning and bicycling.

Researchers found that only 1,270 participants – about 27 percent -- reported the highest level of exercise. Those who got less than 150 minutes of exercise had increased rates of depression, anxiety and sleep problems:

• Depression was reported by nearly half of people who got no exercise, compared to 25% of those that exercised the most.

• Anxiety was reported by 39% of people in the no exercise group, compared to 28% of people in the high exercise group.

• Sleep problems were reported by 77% of people in the no exercise group, compared to 61% in the high exercise group.

Researchers also found an association between exercise and increased frequency of migraines. Among people in the no exercise group, nearly half had 25 or more headache days per month. That compares to only 28% of people in the high exercise group.

“There are new therapeutics available for migraine, but they are very expensive. People with migraine should consider incorporating more exercise into their daily life because it may be a safe and low-cost way to manage and minimize some of the other problems that often accompany migraine,” said Dyess.

Two-and-a-half hours a week of moderate to vigorous exercise, or 150 minutes, is the minimum amount recommended by the World Health Organization.

The study findings, which will be presented at the annual meeting of the American Academy of Neurology in April, have not yet been peer-reviewed or published. One weakness of the study was that participants self-reported their exercise minutes, rather than having their activity monitored with a device. It also only shows an association between exercise and migraines, and does not prove cause and effect. 

Excedrin Brands Recalled Due to Faulty Packaging

By Pat Anson, PNN Editor

One of world’s most widely used over-the-counter pain relievers has turned into a real headache for GlaxoSmithKline (GSK).

The British pharmaceutical giant has recalled over 433,000 bottles of Excedrin because of holes found in bottles of five Excedrin brands: Excedrin Migraine Caplets, Excedrin Migraine Geltabs, Excedrin Extra Strength Caplets, Excedrin PM Headache Caplets and Excedrin Tension Headache Caplets.

There have been no reports of any injuries as a result of the faulty bottles, but GSK recalled them because of the risk of Excedrin tablets falling out and being swallowed by young children. Under U.S. federal law, the tablets must be sold in child resistant packaging.

“While the likelihood there are bottles on the market with holes is low, we are asking anyone who has purchased large-sized Excedrin (50 count and above) to check their Excedrin products and if there is a visible issue, contact GSK Consumer Relations at 1-800-468-7746 for a full refund. If your Excedrin bottle is not damaged, the product is safe to use as directed on the label,” GSK said in a statement.

GsK IMAGE

“We take product safety very seriously at GSK and while we have not received any complaints or safety concerns to date on this potential problem, we are still letting consumers know so they can check their Excedrin bottles themselves. We sincerely apologize for any inconvenience, and please be assured we are working closely with the bottle manufacturer to fix this problem as quickly as we can.”

The bottles were sold at pharmacies, stores and online from March 2018 through September 2020. There was no explanation given for what caused the holes or why it took so long for GSK to recognize there was a problem and order a recall.

In January, GSK temporarily halted production of Excedrin Extra Strength and Excedrin Migraine due to “inconsistencies” in their ingredients. That led to spot shortages of the pain relievers.

In 2012, an Excedrin manufacturing plant in Nebraska was shut down for several months after Excedrin bottles were found to contain broken and stray tablets for other medications. At the time, the Excedrin brand was owned by Novartis.

An FDA investigation found that Novartis failed to adequately investigate hundreds of consumer complaints of foreign products found in over-the-counter drugs produced at the Nebraska plant. GSK now holds majority ownership of Excedrin through a joint venture with Novartis.

A recent study found GSK to be the most heavily fined drug company in the United States.  GSK paid nearly $9.8 billion to settle 27 cases brought against it for bribery, corruption, improper marketing, pricing violations and selling adulterated drugs.

Daily Drop of CBD Oil Reduces Migraine Headaches

By Pat Anson, PNN Editor

A CBD oil formulated for migraine sufferers significantly reduces the number of migraine headaches, according to a survey conducted by Axon Relief, a Utah-based company that makes a line of therapeutic CBD products.

“Our goal was to put out a CBD oil that is specific for people with migraine and to get feedback from them. There is a lot of anecdotal evidence that it works, but we haven’t seen any clinical data really behind it. And so this is kind of a first effort of ours to get some directional data on how effective this is,” says Ben Rollins, founder of Axon Relief.

Axon’s CBD Oil is made from pure hemp seed oil and has about 30mg of CBD per dose, a stronger than average dosage of cannabidiol. It contains no extra flavors, colors or THC (tetrahydrocannabinol), the psychoactive ingredient in cannabis, and is tested by a third-party lab.

The company asked new users of its CBD oil to take the Headache Impact Test (Hit-6™) both before and after a 30-day trial period. The questionnaire asks participants about the frequency and severity of their migraines, and how it impacts their daily lives.

Of the 105 customers who participated in the survey, 86 percent said a daily dose of the CBD oil reduced the impact of their headaches. On average, they also had nearly four fewer headache days per month.

The number of participants with chronic migraine – daily headaches – fell from 15 at the start of the study to 10 after the trial period, a 33% decline.

AXON RELIEF IMAGE

“Since the '90s I've been on constant high doses of carbamazepine and gabapentin. The periodic pain breakthroughs were only controlled by hydrocodone,” one user said. “What a change CBD Oil has made: no more carbamazepine or hydrocodone, and only half the gabapentin -- and far better pain control.”

Another participant said the CBD oil “significantly helped with my chronic migraines. If taken at onset, I can rely on it to take the edge off relatively quickly."

Previous studies have found that inhaled and ingested cannabis help reduce migraine pain.  A recent study of nearly 10,000 people in the U.S. and Canada who used a migraine tracking app found that 82 percent who used cannabis believed it was an effective pain reliever.    

A 2017 study conducted in Israel found that combining THC and CBD in a 200mg oral dose reduced pain by 55 percent in a small group of migraine sufferers.

And a 2016 study at the University of Colorado found that inhaled and ingested cannabis significantly reduced the number of migraine headaches. Inhalation appeared to provide the fastest results, while edible cannabis took longer to provide pain relief.

Axon Relief will soon be introducing an extra strength version of its CBD oil, which will contain about 100mg of CBD per dose. The company is also releasing a new dietary supplement in capsule form that combines CBD with magnesium, CoQ10 and riboflavin – ingredients recommended by the Migraine Trust. 

Survey Finds Patients Wary of Trying CGRP Migraine Drugs

By Pat Anson, PNN Editor

Khloe Kardashian and Serena Williams have their work cut out for them. Despite their endorsement of a new type of migraine medication, many patients remain wary of the drugs and few have tried them, according to a large new survey.

The annual survey of nearly 4,700 migraine patients by Health Union found that about one in four (26%) are currently using a preventive CGRP medication, down from 29% in last year’s survey. And only 11 percent of patients said they were using a CGRP to treat migraine pain.

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 four injectable CGRP inhibitors (Aimovig, Ajovy, Emgality, Vyepti) to prevent migraine and two CGRP tablets for acute migraine (Ubrelvy, Nurtec). The latter two were recently endorsed by reality star Kardashian and tennis star Williams.   

Although Eli Lilly, Teva, Amgen, and other drug companies have aggressively marketed CGRP medications and even given the drugs away for free to get people to try them, sales growth has been slow. Only Aimovig and Emgality are used by at least 10 percent of migraine patients.

PERCENTAGE OF PATIENTS CURRENTLY USING CGRP INHIBITORS

SOURCE: HEALTH UNION 'MIGRAINE IN AMERICA 2020'

Most migraine patients continue to rely on older and cheaper medications such as triptans, anti-depressants, anti-convulsants, over-the-counter drugs, and Botox injections.

The Health Union survey helps explain why. While most patients are aware of CGRP inhibitors and nearly half (43%) had tried a preventive CGRP, most stopped taking them after trying just one brand. That’s not uncommon for migraine sufferers, who often have try multiple treatments before finding one that works.   

“Everybody’s experience with treatment is different. And the fact that there are multiple brands available is actually a really good thing. Because some of them just happen to work better for some people than others,” says Brian Green, Health Union’s vice-president of community business solutions.

CGRP’s do work for some patients. The Health Union survey found that 58% of patients currently using a preventive CGRP reported having less head pain. And nearly half said they didn’t react as strongly to migraine triggers such as loud noises and bright light.  

Those who had heard of preventive CGRP medications but had not tried them cited a number of reasons:

• 44% Doctor has not recommended it

• 27% Concerned about side effects

• 21% Concerned about long-term safety

• 19% Can’t afford them

• 14% Insurance won’t cover

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

Nearly half the patients surveyed said they were still using triptans or over-the-counter pain medication for migraine relief. Antidepressants and Topamax were the most commonly used medications for migraine prevention. 

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.

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.