Why Autumn Weather Is Often Miserable for Pain Patients

Intellectually, I love the concept of a crisp autumn day. I love the idea of pumpkin spice lattes, crockpot chili, and cozy scarfs. But in practice, the intense temperature swings are pretty horrible for me every year.

The cool fall weather here in Northern Illinois is always devastating on my body. Indeed, my chronic pain has been 10/10 the last few days as the temperatures start their yearly drop, and it rains non-stop. 

It’s the same with spring too. Regardless of how much I’m longing for warmer weather every March, the shift from winter to summer means I spend most of the spring in too much pain to function. 

To me, it is obvious that these weather changes impact my pain. I’ve been dealing with it for more than a decade now. And every year, spring and autumn are especially bad. 

Surprisingly, the medical community still questions whether or not the link between weather and pain is real though – and if it is real, why it might be happening. 

“Research still hasn't confirmed a cause-and-effect link between weather and joint pain, though many people insist they can predict the weather based on such aches,” writes Toni Golen, MD, Editor in Chief of Harvard Women's Health Watch, in a 2022 article in Harvard Health,  

A 2015 study looked at whether daily weather conditions and changes in the weather influenced joint pain in older people with osteoarthritis in six European countries.

While they did find a causal link, they hesitated to call it a direct cause, saying that “the associations between day-to-day weather changes and pain do not confirm causation.”

In other words, researchers did not want to say outright that changes in the weather directly causes pain spikes. 

So I guess you’ll have to hear it from me instead: As a chronic pain patient, I can confirm that the effect is real, and it’s not in your head. Weather definitely causes pain spikes.

What might be causing it though? Golen explains that one theory is that changes in barometric pressure — which often happen as the weather changes — trigger pain in the joints. 

“Less air pressure surrounding the body can allow muscles, tendons, and other tissues around joints to expand,” she explains. “This can place pressure on joints, possibly leading to pain.”

Another theory is that cold, damp days make you more likely to do things that can worsen joint pain or stiffness, such as sitting on the couch too long watching movies. 

“Also, since you're expecting discomfort when the weather shifts, you may notice joint aches more than you would otherwise,” Golen adds. “To ward off weather-related joint pain, keep moving with regular exercise and stretching.”

I have to say, the second theory reads as a bit insulting to me. It sounds like health professionals are trying to find another way to blame patients for their pain. 

Personally, I also know that being sedentary is not the cause of my increased pain when the weather changes. That’s partly because when I wake up with pain in the morning, trying to shower and get out of the house quickly is likely to aggravate it. Also, as someone who works from home, I spend most of my days sitting down with a laptop and that usually doesn’t cause my pain to spike.  

As a chronic patient, I also don’t need a study to confirm my experience. I know weather changes cause a pain spike for me, and over the years I’ve learned to cope with it by accepting it. My life is set up so that most of the time, on bad pain days, I have the ability to rest as needed. 

When I first started having daily chronic pain, I would get very stressed about pain spikes, which would make them worse and harder to get under control. But now I know that keeping myself as calm as possible is the key to riding it out. 

I also know that it’s very likely that the pain will start to subside to more manageable levels after a couple of days at the most. And I know to take advantage of my low-pain days to get as much done as possible. In fact, I’m using one this week to write this column.

To me, the link between weather changes and pain spikes is so obvious, that I can’t even believe any doctors would still question it. If you’re among those struggling as the seasons change though, just know, I believe you. 

Cheap Migraine Drugs More Effective Than New Expensive Ones

By Pat Anson

Migraine treatment drugs known as triptans are more effective in relieving acute migraine pain than new expensive medications and should be used more widely, according to new study published in The BMJ.

A team of researchers at Oxford University analyzed the results from 137 clinical studies to see which migraine drugs were more effective in helping patients become pain-free after two hours and whether that relief was sustained 24 hours later. Nearly 90,000 people participated in the studies, over 85% of them women.

Four triptans - eletriptan, rizatriptan, sumatriptan, and zolmitriptan – were rated the best overall, ahead of rimegepant (Nurtec), ubrogepant (Ubrelvy) and lasmiditan (Reyvow) in efficacy and tolerability.

“Overall, the results of our network meta-analysis suggest that the best performing triptans should be considered the treatment of choice for migraine episodes owing to their capacity for inducing rapid and sustained pain freedom, which is of key importance for people with migraine,” wrote lead author Andrea Cipriani, MD, a professor of psychiatry and director of the Precision Psychiatry Lab at Oxford.

Triptans work by narrowing blood vessels in the brain and preventing the release of chemicals that cause migraine pain; while rimegepant and ubrogepant inhibit calcitonin gene-related peptides (CGRPs), a protein that triggers pain. Lasmiditan reduces pain by binding to serotonin receptors in the brain.

The drugs’ mechanisms of action are different and so is their cost. A packet of 6 tablets of eletriptan costs about $106, while a similar-sized packet of rimegepant (Nurtec) costs $1,061; ubrogepant (Ubrelvy) costs $1,097; and lasmiditan (Reyvow) is priced at $790. The cost of those three drugs is much higher because they are only available as brand name medications, while triptans are widely available in cheaper generic formulations.

Despite their cost and extensive marketing promoting their use, lasmiditan, rimegepant, and ubrogepant were rated no more effective in treating migraine pain than over-the-counter drugs such as acetaminophen (paracetamol) and non-steroidal anti-inflammatory drugs (NSAIDs). Researchers say those OTC pain relievers should be considered second line options, if triptans are ineffective.  

“While the recent introduction of lasmiditan, rimegepant, and ubrogepant has expanded options for the acute treatment of migraine, the high cost of these newer drugs, along with the substantial adverse effects of lasmiditan (dizziness), suggest their use as third line options, after the less expensive, similarly efficacious, second line options,” researchers said.

“Limited access to triptans and their substantial under-utilization represents missed opportunities to offer more effective treatments and deliver better quality of care to people who experience migraine.”

Some people can’t take triptans due to cardiovascular problems or unwanted side effects, but researchers say the best performing triptans should be included in the World Health Organization’s List of Essential Medicines to help expand their use.

Another recent study also rated triptans as superior to other migraine medications, although that research didn’t include the newer CGRP inhibitors.

Migraine affects about 39 million people in the United States and 1.1 billion worldwide. In addition to headache pain, migraine can cause nausea, blurriness, and sensitivity to light or sound. Women are three times more likely to suffer from migraines than men.  

Direct-to-Consumer Prescription Programs Seem Ripe for Misuse

By Crystal Lindell

Two large pharmaceutical companies have launched websites that help consumers get prescriptions to the medications that they make – and I’m honestly surprised that the entire setup is even legal.

Pfizer launched PfizerForAll in August, while Eli Lilly started LillyDirect back in January. Both websites connect patients with supposedly independent doctors, who can then write prescriptions – for Pfizer or Lilly medications, of course. Both companies will then help facilitate getting the prescription filled, even offering to connect patients with direct-to-home delivery. 

While direct-to-consumer prescriptions may seem like a win for patients – considering how overly complicated and expensive the U.S. healthcare system is – it also seems ripe for misuse. And when it comes to healthcare, that can have serious consequences, up to and including death.

Pfizer says its new website serves patients seeking treatment for migraines, COVID-19 or influenza, as well as adults seeking vaccines for preventable diseases, including COVID, flu, RSV and pneumococcal pneumonia. 

To be more specific, PfizerForAll facilitates patient access to Pfizer medications for migraine, COVID-19 or flu, as well as Pfizer vaccines. Maybe they should just call it AllForPfizer.

Meanwhile, Eli LIlly’s site is for patients seeking treatment for obesity, migraine and diabetes. Like Pfizer’s program, LillyDirect provides access only to “select Lilly medicines.” Maybe they should change the name to DirectToLilly. 

Both companies say their direct-to-consumer programs are designed to make things easier for patients who lack the time, knowledge and resources to manage their own health. 

“People often experience information overload and encounter roadblocks when making decisions for themselves or their family in our complex and often overwhelming U.S. healthcare system. This can be extremely time-consuming and lead to indecision or inaction – and as a result, poor health outcomes,” Aamir Malik, Executive Vice President and Chief U.S. Commercial Officer for Pfizer, said in a press release.

"A complex U.S. healthcare system adds to the burdens patients face when managing a chronic disease. With LillyDirect, our goal is to relieve some of those burdens by simplifying the patient experience to help improve outcomes," David Ricks, Lilly's chair and CEO, said when LillyDirect was launched

To make it easier for patients to buy Pfizer and Lilly products, both companies offer similar amenities. 

PfizerForAll boasts access to same-day doctor appointments; home delivery of prescriptions, over-the-counter drugs and tests; appointment scheduling for vaccines; and even help paying for Pfizer medicines. 

The LillyDirect site is similar. It offers "independent healthcare providers” and home delivery of Lilly medicines through “third-party pharmacy dispensing services." Lilly says its vendors make treatment decisions based on their own “independent medical judgment.”

So, yes, patients will get appointments with supposedly independent doctors. But something tells me the doctors getting booked with patients via Lilly’s website aren’t going to be writing any prescriptions for Pfizer medications. Or vice versa. 

I’m also very skeptical of the claim that doctors aren’t getting any money from the companies directly. Even if they are only getting referrals, that’s more than enough to heavily incentivize doctors to only prescribe medications that those companies make. Especially if the doctors are told that the patient they are seeing was referred to them by the pharmaceutical company itself.

Personally, when I see a doctor, I want them to write prescriptions based on what’s in my best interest – not what’s in the best interest of a pharmaceutical company. Perhaps it's naive and idealistic of me to still believe that doctors are writing prescriptions based solely on a patient’s need for that specific medicine.  

Perhaps healthcare in the United States is already so far beyond that thought process that these new websites aren’t too much of a leap. After all, pharmaceutical companies have long been working hard to influence doctors. So, maybe this is just the next logical step. 

Whenever I go to a makeup store like Ulta, I’m well aware that the seemingly helpful sales clerks are all trying to push me toward a specific lipstick brand. They may even get commissions from the lipstick company for making a sale. 

But, the thing is, what brand of lipstick I wear isn’t a life or death decision. I expect more from companies that make medications. Even if they don’t hold themselves to a higher standard, I expect more from the government regulators who allow this sort of thing. 

Yes, healthcare in the United States is horrific. I know that firsthand. I’m just not convinced that pharmaceutical companies have much interest in helping to fix that. 

Can Psychedelics Be a New Option for Pain Management?

By Kevin Lenaburg

Science, healthcare providers and patients are increasingly finding that psychedelics can be uniquely effective treatments for a wide range of mental health conditions. What is less well-known, but also well-established, is that psychedelics can also be powerful treatments for chronic pain.

Classic psychedelics include psilocybin/psilocin (magic mushrooms), LSD, mescaline and dimethyltryptamine (DMT), a compound found in plants and animals that can be used as a mind-altering drug. Atypical psychedelics include MDMA (molly or ecstasy) and the anesthetic ketamine.

More than 60 scientific studies have shown the ability of psychedelics to reduce the sensation of acute pain and to lower or resolve chronic pain conditions such as fibromyalgia, cluster headache and complex regional pain syndrome (CRPS).

The complexity of pain is well matched by the multiple ways that psychedelic substances impact human physiology and perception. Psychedelics have a number of biological effects that can reduce or prevent pain through anti-nociceptive and anti-inflammatory effects. Psychedelics can also create neuroplasticity that alters and improves reflexive responses and perceptions of pain, and helps make pain seem less important. 

New mechanisms of action for how psychedelics improve pain are continually being discovered and proposed. Mounting evidence seems to show that a confluence of biological, psychological and social factors contribute to the potential of psychedelics to treat complex chronic pain. 

It is premature to state that there is one key or overarching mechanism at work. Research continues to explore different ways that psychedelics, combined with or without adjunctive therapies, can impact a wide range of pain conditions.

The National Institutes of Health recently posted a major funding opportunity to study psychedelics for chronic pain in older adults. And for the first time, PAINWeek, one of the largest conferences focused on pain management, has an entire track dedicated to Psychedelics for Pain at its annual meeting next month in Las Vegas. 

Clearly, pain management leaders are welcoming psychedelics as a vitally needed, novel treatment modality, and it is time for healthcare providers and patients to begin learning about this burgeoning field.

It is important to note that all classic psychedelics are currently illegal Schedule I controlled substances in the US. The FDA has granted Breakthrough Therapy Designation to multiple psychedelics, potentially accelerating access, but the road to approval at the federal level is long. 

However, at the state level, the landscape is changing rapidly. Similar to how states led the way in expanding legal access to cannabis, we are now seeing the same pattern with psychedelics. 

In 2020, Oregon voters approved an initiative that makes facilitated psilocybin sessions available to adults who can afford the treatment. 

Voters in Colorado approved a similar measure in 2022, with services becoming available in 2025. To become a certified facilitator in Colorado, individuals must pass a rigorous training program that includes required instruction on the use of natural psychedelics to treat chronic pain. 

This coming November, voters in Massachusetts will also decide on creating legal access to psychedelics. 

Over the next decade, we will likely see multiple pathways to access, such as continued expansion of state-licensed psychedelic therapies; FDA-approved psychedelic medicines; and the latest proposed model of responsible access, Personal Psychedelic Permits. The last option would allow for the independent use of select psychedelics after completing a medical screening and education course focused on benefits and harm reduction. Overall, we need policies that lead to safe supply, safe use and safe support.

As psychedelics have become more socially accepted and available, rates of use are increasing. This includes everything from large “heroic” doses, where people experience major shifts in perception and profound insights, to “microdoses” that are sub-perceptual and easily integrated into everyday life. 

In the area of chronic pain, a lot of the focus is on finding low-doses that are strong enough to reduce pain, but have no or minor visual effects. This amount seems sufficient for many people to activate the necessary receptors to reduce chronic pain.

While doctors are years away from being able to prescribe psychedelics, increasing public usage indicates that now is the time for the medical community to become more knowledgeable about psychedelic-pharmaceutical interactions and psychedelic best practices to serve the safety and healing of their patients.

We also need healthcare providers and pain patients to join the advocacy fight for increased research and expanded access to psychedelics. Providers have the medical training and knowledge to treat pain, while patients often have compelling personal stories of suffering and their own form of expertise based on lived experience. 

One of the most effective lobbying tandems is a patient who can share a powerful personal story of healing, hope and medical need, combined with the expertise and authority of a doctor. Together, we can create a world with responsible, legal access to psychedelic substances that lead to significant reductions in pain and suffering.

Kevin Lenaburg is the Executive Director of the Psychedelics & Pain Association (PPA) and the Policy Director for Clusterbusters, a nonprofit organization that serves people with cluster headache, one of the most painful conditions known to medicine. 

On September 28th and 29th, PPA is hosting its annual online Psychedelics & Pain Symposium, which features presentations from experts and patients in the field of psychedelics for chronic pain and other medical conditions. The first day is free and the second day is offered on a sliding scale, starting at $25.

Migraine Drug May Prevent Headaches in Hot Weather

By Pat Anson, PNN Editor

With a dangerous heat wave expected this week in the Midwest and Northeast, the National Weather Service has issued “heat alerts” from Iowa to Maine through Friday. Temperatures are expected to reach the mid to upper 90’s, although it will feel hotter due to high humidity in some areas.

Health experts are giving the usual precautions about heat safety, such as staying hydrated and avoiding strenuous outdoor activity, but migraine sufferers may just want to stay inside in a cool, dark place. While there are no clear links between hot weather and migraine, the American Migraine Foundation says that seasonal changes in weather can trigger a migraine attack.

There are currently no FDA-approved treatments for the prevention of weather-related migraines, but according to a preliminary study, one of the new migraine drugs that block proteins known as CGRPs (calcitonin gene-related peptides) may help prevent headaches in hot weather.

A team of researchers analyzed over 71,000 daily diary records of 660 patients with episodic migraine, comparing them with local weather data on the same days. They found that for every temperature increase of 10 degrees Fahrenheit, there was a 6% increased risk of a headache.

“What we found was that increases in temperature were a significant factor in migraine occurrence across all regions of the United States,” says lead author Vincent Martin, MD, director of the Headache and Facial Pain Center at the University of Cincinnati. “It’s pretty amazing because you think of all the varying weather patterns that occur across the entire country, that we’re able to find one that is so significant.”

When researchers took a closer look at migraine patients being treated with fremanezumab, which is sold under the brand name Ajovy, the association between hot weather and headaches completely disappeared.

Ajovy is an injectable migraine prevention drug made by Teva Pharmaceuticals, which funded the study. Teva also paid consulting fees to Martin, who is president of the National Headache Foundation.

“This study is the first to suggest that migraine specific therapies that block CGRP may treat weather associated headaches,” says co-author Fred Cohen, an assistant professor of medicine at Icahn School of Medicine in New York City.

Findings from the study were recently presented at the American Headache Society’s annual meeting in San Diego, California. If the findings are confirmed in future studies, Ajovy and other CGRP inhibitors have the potential to help migraineurs who suffer from weather-related triggers.

The medications are not cheap. The listed cost for Ajovy is $640 for one monthly dose, although out of pocket costs will vary depending on insurance.

Research Suggests Chronic Pain Should be Treated Differently in Men and Women

By Pat Anson, PNN Editor

Why are women more likely than men to suffer from fibromyalgia, osteoarthritis, irritable bowel syndrome, and other chronic pain conditions?  

Various theories have been proposed over the years, such as gender bias in healthcare, the lingering effects of childhood trauma, and women “catastrophizing” about their pain more than men.

Now there’s a new theory, which could radically change how men and women are treated for pain.

In a groundbreaking study published in the journal BRAIN, researchers at University of Arizona Health Sciences identified two substances – prolactin and orexin B – that appear to make mice, monkeys and humans more sensitized to pain. Prolactin is a hormone that promotes breast development and lactation in females; while orexin B is a neurotransmitter that helps keep us awake and stimulates appetite.

Both males and females have prolactin and orexin, but females have much higher levels of prolaction and males have more orexin.  In addition to promoting lactation and wakefulness, both substances also appear to play a role in regulating nociceptors, specialized nerve cells near the spinal cord that produce pain when they are activated by a disease or injury.

“Until now, the assumption has been that the driving mechanisms that produce pain are the same in men and women,” says Frank Porreca, PhD, research director of the Comprehensive Center for Pain & Addiction at UA Health Sciences. “What we found is that the basic, underlying mechanisms that result in the perception of pain are different in male and female mice, in male and female nonhuman primates, and in male and female humans.”

Porreca and his colleagues made their discovery while researching the relationship between chronic pain and sleep.  Using tissue samples from male and female mice, rhesus monkeys and humans, they found that prolactin only sensitizes nociceptors in females, regardless of species, while orexin B only sensitizes the nociceptors of males.

The research team then tried blocking prolactin and orexin B signaling, and found that blocking prolactin reduced nociceptor activation only in female cells, while blocking orexin B only affected the nerve cells of males. In effect, they found that there are distinctive “male” and “female” nociceptors.  

“The nociceptor is actually different in men and women, different in male and female rodents, and different in male and female non human primates. That’s a remarkable concept, because what it's really telling us is that the things that promote nociceptive sensitization in a man or a woman could be totally different,” Porreca told PNN. “These are two mechanisms that we identified, but there are likely to be many, many more that have yet to be identified.”

Once such mechanism could be calcitonin gene-related peptides (CGRPs), a protein that binds to nerve receptors in the brain and trigger migraine pain. In a recent study, Porreca suggested that sexual differences may be the reason why migraine drugs that block CGRPs are effective in treating migraine pain in women, but are far less effective in men.  

Until these differences are more fully understood, Porreca says clinical trials should be designed to have an equal number of men and women. That way differences between the sexes could be more easily recognized and applied in clinical practice.

For example, therapies that block prolactin may be an effective way to treat fibromyalgia in women, while drugs that block orexin B might be a better way to treat certain pain conditions in men.

“We have an opportunity to develop therapies that could be more effective in treating pain in a man or in a woman than the generalized kinds of therapies that we use now,” said Porreca. ‘I think it's critically important that these pain syndromes really be taken very seriously. And that we find better ways of treating female pain and also male pain.” 

Work Comp Claims for Opioids Down Significantly

By Pat Anson, PNN Editor

Workers’ compensation claims in the U.S. for opioids and other pain relievers fell significantly in 2023, one of the largest drops the work comp industry has seen in years, according to a new report.

San Diego-based Enlyte analyzes drug utilization and spending trends annually for property and casualty insurers. The company’s Drug Trends Report for 2023 estimates that overall opioid use per claim fell by 9.7 percent, with the use of sustained-release opioids such as oxycodone down more than 10 percent.

Surprisingly, work comp claims for non-opioid pain relievers also fell, even though they are increasingly prescribed as alternatives to opioids. Claims for non-steroidal anti-inflammatory drugs (NSAIDs) fell by 3% last year, with anticonvulsants like gabapentin down 7.4% and antidepressants such as duloxetine falling 6.1%. 

"This, by far, marks one of the largest drops in opioid utilization we've seen in years," Nikki Wilson, PharmD, senior director of clinical pharmacy solutions at Enlyte, said in a press release. "In addition, opioid alternatives commonly prescribed to manage acute and chronic pain also experienced decreases in utilization per claim, although to a lesser degree than opioids."

Enlyte said the decline in opioid use was “supported by prescribing guidelines,” noting that claims for high-dose opioid prescriptions have fallen for nine consecutive years. The 2016 CDC opioid guideline urged doctors not to prescribe doses higher than 90 morphine milligram equivalents (MME) per day. Although that recommendation is voluntary, it has taken root in many laws, regulations and insurance policies governing the use of opioids.

As a result, non-opioid analgesics and muscle relaxants are used more often than opioids for pain management during the first two years of a work comp claim. Only afterwards are sustained-release opioids used more frequently for chronic pain caused by job-related injuries.

Even though opioid use has fallen dramatically in recent years, opioids remain the top therapeutic class for claims, followed by NSAIDs, anticonvulsants, muscle relaxants, antidepressants and topical medications. Those six therapeutic classes represent over two-thirds of the prescription drug claims in 2023.

Respiratory and Migraine Drugs  

While the overall cost of prescription drugs fell slightly (down 0.2%) in 2023, the price of respiratory and migraine medications rose significantly, up 14.7% and 10.2%, respectively.

Newer migraine drugs that block calcitonin gene-related peptides (CGRPs) are some of the most expensive medications, with the average wholesale price of a Nurtec prescription reaching $1,916 and $1,654 for a Ubrelvy prescription.      

"Basically, what's driving these trends are the costs of the top three medications in their respective classes," Wilson said. "For instance, for migraine medications, Nurtec ODT is prescribed about 15% of the time yet makes up more than 31% of the total drug spend in this category. Similarly, respiratory medication like Trelegy Ellipta is prescribed about 10%, but accounts for nearly 19% of all respiratory medication total costs."

Enlyte reported the number of retail and mail order prescription drug claims is trending downward due to an “evolving work environment.” More people are working from home and as independent contractors, reducing the number of on-site job injuries and employee compensation claims.  

Experts Say CGRP Drugs Are First-Line Therapies for Migraine Prevention

By Pat Anson, PNN Editor

Migraine medications that block calcitonin gene-related peptides (CGRPs) are “equal to or greater” than other migraine prevention drugs and should be considered first-line therapies, according to a new guideline from the American Headache Society (AHS).

It’s the first time the organization has endorsed CGRP inhibitors for migraine prevention, despite their high cost and limited availability due to insurance requirements. Many insurers have step-therapy policies that require patients to start with cheaper first-line treatments before trying other drugs.

"Moving CGRP-targeting therapies to the first line of treatment could have a transformational impact on the prevention of migraine attacks and their associated burdens," Andrew Charles, MD, AHS president and lead author of the guideline recently published in the journal Headache. 

CGRP inhibitors block a protein that binds to nerve receptors in the brain and trigger migraine pain. Since 2018, the FDA has approved over half a dozen CGRP medications for migraine prevention and/or treatment, the biggest innovation in migraine therapy in decades.   

Older drugs that have long been used for migraine prevention were originally developed for other conditions. They include amitriptyline, a tricyclic antidepressant; simvastatin, which is used to control cholesterol; topiramate (Topamax), an antiseizure medication; and beta-blockers commonly used to control blood pressure.  

The AHS says there is growing “real world” experience that CGRP inhibitors work better than the older, repurposed medications.

“The evidence for the efficacy, tolerability, and safety of CGRP-targeting migraine preventive therapies is substantial, and vastly exceeds that for any other preventive treatment approach,” the AHS said. “The data indicates that the efficacy and tolerability of CGRP-targeting therapies are equal to or greater than those of previous first-line therapies and that serious adverse events associated with CGRP-targeting therapies are rare.”

The biggest problem with CGRP inhibitors is their cost, which can reach tens of thousands of dollars a year. Eight doses of Nurtec, a tablet taken daily, cost over $1,000; while the listed price for Emgality is $706 for a self-injectable syringe used monthly. Prices will vary, depending on insurance and whether a patient qualifies for discounts or patient assistance programs.

By comparison, amitriptyline and simvastatin are bargains. A bottle of 30 simvastatin tablets will cost about $14, while amitriptyline costs about $13 for a supply of 28 tablets. A recent study suggests that amitriptyline and simvastatin work just as well as CGRP inhibitors in reducing the need for medications to treat migraine pain, an indication that they are effective at prevention.

Despite the disparity in cost, the AHS maintains the overall benefits of CGRP inhibitors may justify the price. There are substantial hidden costs to migraine attacks, which can result in lost productivity, income, education, and personal relationships.   

“We recognize that the CGRP-targeting preventive therapies are significantly more expensive on a yearly basis than most of the previously established therapies, and some argue that this expense is a primary consideration in clinical decision-making,” the AHS said. “On the other hand, we argue that it is critically important to consider not only the direct cost of the treatment but also the substantial costs to the individual and society if effective treatment is delayed.”

Migraine affects about 39 million people in the United States and 1.1 billion worldwide. In addition to headache pain, migraine can cause nausea, blurriness, and sensitivity to light or sound. Women are three times more likely to suffer from migraines than men.  

Neurological Conditions Now Leading Cause of Chronic Illness

By Pat Anson, PNN Editor

The number of people living with neurological conditions such as migraine, diabetic neuropathy, epilepsy, stroke and dementia has risen significantly over the past 30 years, making it the leading cause of chronic illness worldwide, according to a new analysis published in The Lancet Neurology.

An international research team estimates that over 3.4 billion people – about 43% of the global population – had a neurological condition in 2021, replacing cardiovascular disease as the leading cause of poor health.

“The worldwide neurological burden is growing very fast and will put even more pressure on health systems in the coming decades,” said co-author Valery Feigin, MD, Director of the National Institute for Stroke and Applied Neuroscience at Auckland University in New Zealand.

“Yet many current strategies for reducing neurological conditions have low effectiveness or are not sufficiently deployed, as is the case with some of the fastest-growing but largely preventable conditions like diabetic neuropathy and neonatal disorders. For many other conditions, there is no cure, underscoring the importance of greater investment and research into novel interventions and potentially modifiable risk factors.”

A total of 37 disorders affecting the brain and nervous system were included in the study. Collectively, the nerve disorders are responsible for 443 million years of healthy life lost due to illness, disability or premature death, known as disability-adjusted life years (DALYs).

Tension-type headaches (about 2 billion cases) and migraines (about 1.1 billion) are the two most common neurological disorders, while diabetic neuropathy is the fastest-growing one. Painful stinging or burning sensations in the nerves of the hands and feet are often the first symptoms of diabetes.

“The number of people with diabetic neuropathy has more than tripled globally since 1990, rising to 206 million in 2021,” said co-senior author Liane Ong, PhD, from the Institute for Health Metrics and Evaluation at University of Washington. “This is in line with the increase in the global prevalence of diabetes.”

Over 80% of neurological deaths and disability occur in low- and middle-income countries, with western and central sub-Saharan Africa having the highest DALY rates. In contrast, high-income countries in the Asian Pacific and Australasia regions had the lowest rates.

“Nervous system health loss disproportionately impacts many of the poorest countries partly due to the higher prevalence of conditions affecting neonates and children under 5, especially birth-related complications and infections,” said co-author Tarun Dua, MD, Unit Head of WHO’s Brain Health unit.

“Improved infant survival has led to an increase in long-term disability, while limited access to treatment and rehabilitation services is contributing to the much higher proportion of deaths in these countries.”

Medical providers specializing in neurological care are unevenly distributed around the world, with wealthy countries having about 70 times the number of specialists as low-income ones.

Researchers say prevention needs to be a top priority in addressing the growth of neurological conditions. Some disorders, such as stroke and chronic headache, are potentially preventable by lowering risk factors such as high blood pressure, smoking and alcohol use.

The study was funded by the Bill and Melinda Gates Foundation.

Migraine Sufferers Rank Triptans as Most Helpful Medication

By Pat Anson, PNN Editor

A large new study that compared the effectiveness of acute migraine medications found that triptans are two to five times more helpful than ibuprofen and acetaminophen in treating migraine attacks. Triptans were also found to be more effective than Excedrin migraine, opioids, and other non-steroidal anti-inflammatory drugs (NSAIDs).

The study used a unique methodology, gathering data on over 3 million migraine attacks reported by over 278,000 people in the US, UK and Canada who used a smartphone app during a six-year period. The Migraine Buddy app allows users to monitor the frequency of their migraine attacks, triggers and symptoms, and rate how “helpful” or “not helpful” their medications are.

“There are many treatment options available to those with migraine. However, there is a lack of head-to-head comparisons of the effectiveness of these treatment options,” said lead author Chia-Chun Chiang, MD, a neurologist who specializes in Headache Medicine and Vascular Neurology at the Mayo Clinic. “These results confirm that triptans should be considered earlier for treating migraine, rather than reserving their use for severe attacks.”

Chiang and his colleagues looked at a total of 25 medications among seven drug classes. Different dosages and medication combinations were combined in their analysis. Newer drugs that inhibit calcitonin gene-related peptides (CGRP) were excluded because they were not in wide enough use during the study period.

How Patients Rated Effectiveness of Acute Migraine Drugs

NEUROLOGY

The study findings, published in the journal Neurology, ranked several triptans (eletriptan, zolmitriptan, sumatriptan, rizatriptan, naratriptan, almotriptan and frovatriptan) as the most helpful medications, with about 75% effectiveness.

By comparison, acetaminophen (paracetamol) was helpful only 37% of the time.

“Our results strongly support the use of triptans, the first class of migraine-specific medication for the acute treatment of migraine,” researchers reported. “In practice, NSAIDs and acetaminophen are generally the first-line medications utilized for mild to moderate headache, and migraine-specific medications are often reserved for moderate to severe migraine attacks, which could potentially result in under-utilization of triptans or delayed treatment during migraine attacks.”

Participants found NSAID’s more effective than acetaminophen, with ketorolac helpful 62% of the time, indomethacin helpful 57% of the time, diclofenac helpful 56% of the time and ibuprofen helpful 42% of the time.

Excedrin migraine was effective only about half the time, about the same as tramadol and codeine. Opioids are usually not recommended for migraine because they’ve been associated with medication overuse headache.

“For people whose acute migraine medication is not working for them, our hope is that this study shows that there are many alternatives that work for migraine, and we encourage people to talk with their doctors about how to treat this painful and debilitating condition,” said Chiang.

Migraine affects about 39 million people in the United States and is the second leading cause of disability worldwide, according to the American Migraine Foundation.  

Another recent study that compared migraine prevention drugs found that two medications usually used to treat depression and high cholesterol are just as effective as the new CGRP inhibitors. Amitriptyline is a tricyclic antidepressant, while simvastatin is a statin. Both drugs are used off-label for migraine prevention and cost substantially less than CGRP drugs.

Cheap Drugs May Prevent Migraine Just as Effectively as Expensive Ones

By Pat Anson, PNN Editor

Two drugs commonly used to treat depression and high cholesterol are just as effective at preventing migraine as CGRP inhibitors, according to a large new study.

They are also a heck of a lot cheaper.  

Researchers at the Norwegian Center for Headache Research analyzed the prescription drug history of over 100,000 migraine patients in Norway from 2010 to 2020. Their goal was to see if patients reduced their use of medications used to treat acute migraine pain – such as triptan – once they started taking drugs used to prevent migraine.

“When the withdrawal of acute migraine medicines changed little after starting preventive medicines, or people stopped quickly on the preventive medicines, the preventive medicine was interpreted as having little effect,” explained lead investigator Marte-Helen Bjørk, MD, a Professor in the Department of Clinical Medicine, University of Bergen.

“If the preventive medicine was used on long, uninterrupted periods, and we saw a decrease in the consumption of acute medicines, we interpreted the preventive medicine as having good effect.”

Beta blockers are often the first drugs used to prevent migraine attacks, but Bjørk and her colleagues found that three other medications were associated with lesser use of triptans: amitriptyline, simvastatin and CGRP inhibitors.

Amitriptyline is a tricyclic antidepressant that is mostly taken for depression, while simvastatin is a statin used to treat high cholesterol. Both drugs are also used off-label for migraine prevention.

CGRP inhibitors are a relatively new class of medication that block calcitonin gene-related peptides, a protein that binds to nerve receptors in the brain and triggers migraine pain. Since 2018, the FDA has approved over half a dozen CGRP medications, which are considered the biggest innovation in migraine treatment in decades.

However, CGRP drugs are not cheap. Eight doses of Nurtec, a tablet taken daily to prevent and treat migraine, can cost over $1,000, while the listed price for Emgality is $679 for a self-injectable syringe used once a month for migraine prevention. Prices will vary for patients, depending on insurance and whether they qualify for a patient assistance program.

By comparison, amitriptyline and simvastatin are screaming bargains. A bottle of 30 simvastatin tablets will cost about $14, while amitriptyline costs about $13 for a supply of 28 tablets.

When it comes to reducing triptan use, amitriptyline, simvastatin and the CGRP inhibitors performed about the same. During the first 90 days of treatment, nearly 57% of patients taking simvastatin reduced their triptan use, compared to 53% of patients taking amitriptyline and 55% of those taking CGRP medicines.

The study findings, recently published in the European Journal of Neurology, show that patients taking beta blockers, topiramate or clonidine were more likely to keep taking triptans.

“Our analysis shows that some established and cheaper medicines can have a similar treatment effect as the more expensive ones. This may be of great significance both for the patient group and Norwegian health care” says Bjørk, who has already started work on a clinical trial to see if other cholesterol-lowering drugs can prevent migraine.

Migraine affects about 1 billion people worldwide and 39 million 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.

Childhood Trauma and Neglect Increase Risk of Headache Disorders

By Pat Anson, PNN Editor

People who experience traumatic events during childhood, such as physical abuse, sexual abuse or neglect, are more likely to have headache disorders as adults, according to a large new study. The research adds to a growing body of evidence linking adverse childhood experiences (ACEs) to headaches and migraines in adults.

“Traumatic events in childhood can have serious health implications later in life,” says lead author Catherine Kreatsoulas, PhD, of Harvard T.H. Chan School of Public Health. “Our meta-analysis confirms that childhood traumatic events are important risk factors for headache disorders in adulthood, including migraine, tension headaches, cluster headaches, and chronic or severe headaches. This is a risk factor that we cannot ignore.”

Kreatsoulas and her colleagues reviewed 28 studies that examined the childhood histories of nearly 155,000 people in 19 countries. Their findings are published Neurology, the medical journal of the American Academy of Neurology.

About a third of the participants (31%) reported at least one traumatic childhood event. Of those, 26% were diagnosed with a primary headache disorder, compared to 12% of participants who said they experienced no childhood trauma. People who had four or more traumatic events during childhood were more than twice as likely to have a headache disorder than those who had one ACE.

Researchers also examined different types of childhood trauma. Events categorized as “threat” traumas included physical abuse, sexual abuse, emotional abuse, witnessing or being threatened with violence, and serious family conflicts.

Events categorized as “deprivation” traumas included childhood neglect, economic adversity, divorce or separation, parental death, alcohol or substance abuse, and living in a household where someone has a mental illness, chronic illness, disability or is incarcerated.

Threat traumas were linked to a 46% increase in headache disorders, while deprivation traumas were linked to a 35% increase in headaches. Among threat traumas, physical and sexual abuse were associated with a 60% increased risk for headaches. Among deprivation traumas, neglect was linked to a nearly three-fold increased risk for headache disorders.

“Threat or deprivation traumas are important and independent risk factors for headache disorders in adulthood,” said Kreatsoulas. “Identifying the specific types of childhood experiences may help guide prevention and treatment strategies for one of the leading disabling disorders worldwide. A comprehensive public health plan and clinical intervention strategies are needed to address these underlying traumatic childhood events.”

Due to the stigma and sensitive nature of childhood trauma, researchers say it’s likely the number of ACE cases is under-reported by adults.

 “Despite this, the robustness of these findings cannot be underappreciated as the studies composing this meta-analysis represent diverse global regions and the findings supersede cultural contexts,” they said.

The research does not prove that ACEs cause headaches -- it only shows an association.

Previous studies have also linked childhood trauma to an increased risk of chronic pain conditions such as fibromyalgia and lupus, as well as mood and sleep problems.

Woman Files Civil Rights Lawsuit Over Denial of Pain Treatment

By Madora Pennington, PNN Columnist

In September of 2022, millions watched Tara Rule’s emotional video on TikTok, about a doctor who refused to give her a non-narcotic pain medication because it might cause birth defects. The doctor would not even name the drug, even though Rule told him she has no intention of having children because she has Ehler's Danlos syndrome (EDS), a genetic disorder that causes severe health issues.

The 32-year old Rule recently filed a civil rights lawsuit to better establish the illegality of refusing medical treatment to women simply because they are of childbearing age.

Rule’s fight began when neurologist Jonathan Braiman, MD, steered her away from an effective treatment for her agonizing cluster migraines, a common symptom of EDS. According to Yale Medical School, cluster headaches can hurt more than childbirth.

When Rule realized she was being discriminated against by her doctor, she surreptitiously switched on her cell phone to record their discussion, which is legal in New York state. 

Brainman can be heard in the recording asking Rule intrusive questions about her sex life, while ignoring her answers. Rule explained that she was already on a medication that can cause birth defects -- known as teratogenic drug -- and wasn't well enough to have children anyway.

Brainman patronizingly told her she might change her mind if she were to become pregnant. He recommended that she bring in her boyfriend to consent to any treatment that might cause birth defects. Rule left without getting the pain relief she needed for her migraines.

In the parking lot of Albany Medical Center, where the appointment took place, a distraught and tearful Rule made the video and posted it online. Her raw emotion and disturbing story quickly went viral, not only on social media, but in news stories.

In her lawsuit against Braiman and Albany Medical, Rule alleges she was retaliated against by the hospital system. Rule says she was ejected from an unaffiliated urgent care center because Albany Medical had told other hospitals not to treat her. She believes this was a violation of her medical privacy.  

Rule suspects she was blacklisted by other providers in her area. She tried to make an appointment with another neurologist, but was told she was “not an appropriate patient.” Her primary care provider sent a back-dated letter to Rule and her mother saying he was dismissing them as patients. That doctor gave no valid reason for the patient abandonment.

TARA RULE (TIKTOK)

Rule is on disability and lives on less than $1,000 per month. Being banned as a patient is a real hardship.

“Now I have to go to Connecticut to see physicians in a different hospital system. Or travel three and a half hours to New York City. With hotels and gas, it’s very hard. Some of these specialists outside the state are not fully covered by my insurance,” Rule said.

Traveling is made more complicated because Rule can’t stay just anywhere — she needs accessible hotel rooms. And she is accumulating thousands of dollars in debt.

After posting her video, Rule heard from many other patients who have also been discriminated against by their doctors. She felt motivated to find out what legal remedies existed.

With legal guidance, Rule wrote the civil rights complaint herself in what is known as a “federal question” lawsuit, an action that seeks to clarify a constitutional issue in US federal court. Rule has been advised that the medical care she sought does not fall under “conscience protections,” which allow doctors to refuse treatment on religious or moral grounds.  

In preparation for her lawsuit, Rule obtained her medical and insurance records, to help prove that privacy violations occurred. She discovered she had been billed for services not received, and believes her medical records were forged.

Albany Medical did not respond to a request for comment.

Rule’s lawsuit is potentially precedent-setting. It marks the first federal question case against a medical provider for refusing to provide teratogenic drugs because a woman is of “childbearing age.” Refusing to give routine medical care because a patient might get pregnant is discrimination. Patients cannot be forced into unnecessary restraints on their care.

"I am prepared for whatever happens,” says Rule, who is hopeful her lawsuit will help prevent other patients from being discriminated against by their doctors. 

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

'Growing Pains' in Childhood Linked to Migraine

By Pat Anson, PNN Editor

Did you experience “growing pains” as a child? An unusual ache or throbbing in your legs that occurred late in the day and kept you awake at night?

The Mayo Clinic says there’s no evidence that a growth spell actually causes physical pain, and that any discomfort may be caused by a low pain threshold or even psychological issues.

But a small new study suggests something else may be going on: Brazilian researchers say children who have growing pains are significantly more likely to develop migraines – just as their parents did.  Migraine can be hereditary, and if one or both parents have migraine, there’s a 50-75% chance that their children will also.

“In families of children with growing pains, there is an increased prevalence of other pain syndromes, especially migraine among parents,” wrote lead author Raimundo Pereira Silva-Néto. PhD, a neurology professor at Federal University of Delta do Parnaibal. “Children with migraine have a higher prevalence of growing pains, suggesting a common pathogenesis; therefore, we hypothesized that growing pains in children are a precursor or comorbidity with migraine.”

With parental authorization, Silva-Néto and his colleagues followed 78 children between 5 and 10 years of age, who were born to mothers being treated for migraine at a headache clinic. Their findings were published in the journal Headache.

After five years, about half of the children reported growing pains in their lower limbs. Headaches occurred in 76% of those children, with many meeting the criteria for migraine without aura. By comparison, only 22% of the children who did not have growing pains had headaches.

Lower limb pain was reported most often in the calf muscles (70%), usually lasted more than 30 minutes, and occurred more frequently at night.

That nocturnal connection intrigued the researchers, who noted that previous studies have found that sleepwalking, nightmares, and restless leg syndrome also occur more frequently in children who have migraines.   

“There is no definitive explanation for the nocturnal patterns of growing pains, nor for the overlap with sleep disturbances; however, the authors believe the hypothesis of a common pathogenesis with migraine,” researchers concluded. “Pain in the lower limbs of children and adolescents, commonly referred to as GP (growing pains) by pediatricians and orthopedists, may reflect a precursor/comorbidity with migraine.”

Migraine affects about 39 million people in the United States and is the second leading cause of disability worldwide, 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. About one in five teens suffer from migraine.

Head-to-Head Migraine Study Ends in Tie

By Pat Anson, PNN Editor

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

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

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

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

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

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

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

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

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

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

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