Should CDC Be Involved in Cannabis Regulation?

By Pat Anson

If you think the Centers for Disease Control and Prevention bungled its handling of COVID-19 tests and misled the public about the risks of opioid pain medication – then you’re probably not going like a new recommendation from a federal advisory panel.     

The National Academies of Sciences, Engineering, and Medicine (NASEM) wants the CDC to play a much larger role in setting federal policy on cannabis, such as expanding its surveillance of cannabis use and establishing “best practices” for states to follow in cannabis regulation.

In other words, a CDC cannabis guideline that would be used as a model for state laws and regulations, much like the agency’s opioid prescribing guideline was. Only this guideline would go much further.

“The best practices should encompass marketing restrictions, age restrictions, physical retail and retail operating restrictions, taxation, price restrictions, product design, and measures to limit youth access,” NASEM said in a 312-page report released this week. “Once the Centers for Disease Control and Prevention’s best practices have been developed, they should be incorporated into the model legislation.”

Cannabis is currently illegal under federal law, but 38 states and the District of Columbia allow its medical and/or recreational use. At the urging of the Biden Administration, the DEA is considering a proposal to reclassify cannabis as a Schedule III controlled substance, which would allow for some medical use of cannabis under federal law. A final decision is not likely until sometime next year.    

But with a major change in federal policy on the horizon and a hodgepodge of state regulations already in place, NASEM wants federal agencies and Congress to get more involved in setting policy for legalized cannabis.

“There is an urgent need for a coordinated public health approach to cannabis policy in the U.S.,” said Steven Teutsch, a senior fellow at the University of Southern California and chair of the committee that wrote the NASEM report. “Our report shows that cannabis policy often focuses on regulating sales and revenue first, and protecting public health second. Now is the time for the federal government to create guidance for states that have legalized cannabis in the interest of protecting the public’s health.”

The first recommendation from NASEM is for Congress to overhaul the regulation of hemp, which was legalized under the 2018 Farm Bill.  That opened the door for cannabis companies to tweak the chemical composition of hemp-derived Delta-8 THC to make it more potent. Intoxicating edibles containing Delta-8 THC are now widely sold as candy, cookies, gummies and beverages – even in states where medical and recreational cannabis are illegal.

NASEM wants Congress to close that loophole by changing the definition of hemp so that Delta-8 THC is regulated the same way as other cannabis products.

Public Health Campaigns

The report also calls for the CDC to develop “targeted public health campaigns” to warn about the risks of cannabis use by children, pregnant women and older adults.  

The latter is one of the fastest growing segments of the population using cannabis, according to a recent survey that found 12% of Americans over 50 had consumed a THC-containing product in the past year. Only 3% were using cannabis in 2006. Ironically, many older adults use cannabis to manage chronic pain because they are no longer able to obtain opioids after the widespread misapplication of the CDC’s opioid guideline.

The NASEM report also warns about the lobbying influence of the cannabis industry, which it blames for the weakening of cannabis regulations in Colorado and Washington, as well as conflicts of interest and “financial entanglements” that some state regulators have with the industry.

“The influence of the burgeoning legal cannabis industry on policy development raises concern about potential bias. Lobbying efforts by the industry have demonstrably impacted regulation,” the report states.

That’s pretty rich when you consider the many biases and conflicts the CDC had when it secretly developed the opioid guideline, and how CDC insiders hijacked a public hearing to silence anyone who might oppose it. Some CDC consultants were later paid millions of dollars testifying as expert witnesses in opioid litigation.

Conservative critics of the CDC are unlikely to support any effort to get the agency involved in cannabis regulation.  The Heritage Foundation’s Project 2025 calls for the CDC’s budget to be slashed and its ability to set healthy policies severely restricted.

“COVID-19 exposed the Centers for Disease Control and Prevention as perhaps the most incompetent and arrogant agency in the federal government,” wrote Roger Severino, former director of the Office for Civil Rights at the Department of Health and Human Services during the Trump administration.

“Never again should public health bureaucrats be allowed to hide information, ignore information, or mislead the public concerning the efficacy or dangers associated with any recommended health interventions.”

A CDC spokesperson told the Associated Press the agency would study NASEM’s recommendations, but more money would be needed to implement them.

Hurricane Helene Highlights Need for Emergency Prescription Access

By Crystal Lindell

Following the news for Hurricane Helene this week, I’ve been worried about everyone in its path. But it’s the people who rely on prescription pain medication that I am most worried about. 

When natural disasters strike, patients who rely on opioids and other controlled substances can be left to face withdrawal or the black market to fill the gaps until doctors and pharmacies are fully functioning again.

While some states have laws in place to allow people to get early refills of their prescriptions when there’s an impending natural disaster, those laws can specifically exclude controlled substances like hydrocodone and Adderall. 

According to a 2022 article by Healthcare Ready, the laws vary widely state-by-state and are poorly organized. Only 12 states have laws or regulations that allow for emergency prescriptions during a specified public health emergency. About half the states allow for short-term refills of medication during unspecified emergencies. Fifteen states and the District of Columbia don’t have any regulations allowing for emergency prescriptions.

The two states facing the worst from Hurricane Helene, Florida and Georgia, both have laws allowing for emergency prescription refills – but only one allows for refills of opioids. 

Georgia specifically excludes Schedule 2 controlled substances such as codeine, hydrocodone, morphine and amphetamines, according to Atlanta News First. 

Florida’s law is much more expansive. You can obtain a 30-day refill of any prescription medication, as long as your county meets one of the state’s disaster qualifications. 

My guess is that Florida is more lenient due to the state’s reputation as a retirement destination. Older retired people are more likely to need pain medication and more likely to vote. 

It’s understandable that states more commonly hit by hurricanes would have laws in place to address this issue, but every state should allow for emergency prescription refills. Natural disasters like earthquakes, tornadoes and wildfires can happen anywhere. 

Ideally, this would be something best addressed at the federal level, so that patients who have to evacuate their state during emergencies would know they can get refills no matter where they go. Pharmacists would also need to be aware of how to apply the regulations. 

The Food and Drug Administration recommends that patients have at least a week's supply of  medication in case of emergencies – something that’s impossible for many pain patients. You know things are not functioning correctly when a federal agency is giving medical advice that patients are literally unable to follow. 

The last thing anyone facing the threat of losing their home or even their lives should have to worry about is running out of hydrocodone. Even a small daily dose can cause withdrawal if stopped abruptly.

Medication withdrawal in normal conditions can feel like hell. I can’t imagine what it would be like if you also had to deal with the aftermath of a hurricane or wildfire. It could take days or weeks before power is restored, pharmacies to reopen, and supply chains to start functioning again.

Nobody should have to endure that, and with sensible laws in place across the country, nobody would have to. 

Dogs Can Help Us Feel Less Pain

By Pat Anson

If you’re a dog lover like me, you know how beneficial a pet dog can be. Dogs give us unconditional love and companionship, and help us reduce stress, stay active and be socially connected.

What you may not know is that our four-legged friends can also help us feel less pain. In fact, according to a new study, they’re better at it than humans.

A team of European researchers conducted an unusual experiment to see if people experience less pain when their dog was nearby or when they were with a close friend.

They recruited 124 healthy female pet owners to immerse their hands in cold water (about 36°F) for up to five minutes to induce pain. The so-called “cold pressor task” is a common way for researchers to induce acute pain in clinical studies.

For this study, the cold water test was performed in a laboratory while the participants had either their pet dog or a same-sex friend nearby. Some of the women took the test while alone and served as a control group. The interaction of the participants, dogs, and their friends was monitored by video camera.   

The study findings, recently published in the journal Acta Psychologica, suggest that dogs can help people cope with painful situations better than humans can.

“Participants reported and showed less pain and they felt less helpless in the dog condition compared to the alone condition,” wrote lead researcher Heidi Mauersberger, a Research Assistant in the Department of Psychology at Humboldt University in Berlin.

“Participants accompanied by their dog reported less pain and showed lower physiological pain reactions, greater pain tolerance, and less intense facial displays of pain as well as felt less helpless than participants…accompanied by their friends.”

Being with a friend was better than being alone, but Mauersberger says the presence of another human being -- even a close friend -- made the women feel like they were being judged or evaluated.

“In contrast to the presence of pet dogs, the mere presence of close friends may have triggered social demands and social-evaluative threat in the painful situation. In fact, the increased eye contact frequency between participants and friends compared to participants and dogs may be a reason for the heightened threat perceptions in the friend compared to the dog condition.”

To test their theory further, researchers conducted a second test, this time immersing the participants’ hands in cold water while they were with a complete stranger or a dog they were unfamiliar with.

The results were largely the same. The pet owners felt more comfortable and coped better with pain around dogs they had not bonded with. Individuals with positive attitudes about dogs experienced the most pain relief.

“Participants demonstrated better adaptation to pain, exhibited less pain behavior, reported reduced helplessness and higher self-efficacy as well as experienced more positive affect when suffering pain in the presence of unfamiliar dogs compared to the presence of unfamiliar human companions,” said Mauersberger.

To be clear, this experiment wasn’t designed to come up with another wacky treatment for chronic pain. People with chronic pain or taking prescription medication were excluded from the study.

The research was conducted to help demonstrate the value of therapy dogs, which have long been known to provide psychological benefits to people suffering from stress, anxiety or loneliness.

A 2020 study helped explain how that happens. People being treated for fibromyalgia who interacted with a therapy dog had a significant increase in levels of oxytocin – a hormone released by the pituitary gland that’s known as the “cuddle hormone” or “love hormone.” They were also more relaxed, their heart rates slowed, and they had more positive thoughts and feelings.  

Do you have a dog, cat or pet of any kind that helps you feel better? 

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. 

A Medical Enigma I’ll Never Understand

By Pat Akerberg

I recently read Carol Levy’s column describing a medical enigma about a new pain-relieving medication. Carol and I both suffer with the same debilitating condition -- trigeminal neuralgia (TN) – so I was intrigued to learn more about it. Important to note that she has suffered with TN twice as long as I have. Bless you, Carol.

The new medication by Vertex Pharmaceuticals is suzetrigine, which the FDA is fast-tracking with a priority review.  For all the hype, it turns out that suzetrigine is only being studied as a treatment for acute pain and diabetic peripheral neuropathy.  Along with Carol, I had hoped this medication would be something for all of us in pain. Most especially since there hasn’t been any new pain medication for two decades. 

Here’s the medical enigma about the condition we suffer with that I’ll never understand.  Simply put, why can surgeons perform a microvascular decompression (MVD) brain surgery on TN patients when they cannot offer treatment for a bad outcome that might occur (and does 20% of the time)? 

And what happens if the neurosurgeon lies to you before the surgery and falsely claims that he/she can reverse any unwanted outcome? 

As background, I was struck with the lightning bolts of TN in 2009.  Because I wanted to return to work pronto, I chose to have MVD surgery in 2010 that was recommended to halt the horrific pain.  Instead, I wound up being harmed even further by the surgery.

Fast forward to the present, and I’ve been seen by 11 neurologists in my area who were all Ill-equipped to understand TN, let alone how to treat my worsened condition. 

So, I understand the rise of Carol’s hope and excitement about a possible new medication that might help alleviate the neuropathic pain we suffer with. The worst pain known to medical practice is TN, and the idea that using disappointing treatments like Tylenol or suzetrigine for it is truly unfathomable. 

But here’s what else I really don’t understand.  If surgery is allowed for TN, then why is the medical profession unable to deal with the unfortunate, damaging outcomes from it that happen to hundreds of patients like me? 

I’ve been told by neurosurgeons that training in medical schools for TN is woefully lacking.  Yet somehow performing surgeries for TN or other challenging conditions persists, especially for controversial surgeries that don’t have a good track record 6 months later. 

When I asked the neurosurgeon who performed my procedure what went wrong during the surgery, his response was: “No one ever told you that surgery was without risk.”

In other words, “You knew the risk and you chose to do it anyway.” 

Then he told me I should find a psychiatrist since I was so “anxious” about my unfortunate outcome. So much for his emotional intelligence and integrity (or competence for that matter).

Again, who wouldn’t be anxious if they underwent brain surgery thinking they would be rid of the wicked pain, only to wake up in worse pain through no fault of their own?  Imagine my shock afterwards when I learned he lied and couldn’t reverse anything that he claimed he could.

With zero assistance from him, I set out to contact neurological specialists internationally.  When I spoke with a TN neurosurgeon from Israel, he answered the enigma that has bothered me for years.  I’m paraphrasing what he told me, but here’s what he said:

“The United States is cut happy. The U.S. has a medical business model and, as such, they allow surgeries that the rest of the world would never perform given the susceptibility for harm in such a snug, vulnerable brain area.”

WOW.  That explained the run-around I experienced. It also explained why, despite my considerable efforts, I couldn’t get any pain relief (forget justice) for the harmful outcome I suffered with the phantom pain of anesthesia dolorosa.

Then I spoke with several TN experts around the U.S. after sending them my MRI.  Each one told me that since the detrimental outcome of my surgery sensitized my central nervous system, I would no longer be considered “operable” by most TN surgeons anywhere ever. 

Again, WOW.  I really need someone to explain to me why it’s considered okay to perform a risky surgery on someone when there’s no way to treat any disastrous outcome of said surgery.  My experience has been to blame me (the patient) with a neat, tidy self-serving explanation.

I guess it all comes down to how desperate one is to get relief from the pain caused by the “suicide disease.”  That desperation is then exploited with a buyer beware consent document.  

I’ve since learned that consent born out of desperation (or a lie) becomes absolution for the surgeons performing the MVD procedure for TN.  That frees those performing the surgery from their oath to do no harm. 

Here’s the kicker: After having done considerable research, I asked my neurosurgeon if any bad outcome could be reversed later. He answered “yes” in his fervor to ready me for the surgery. So, I signed the consent agreement based on his lie. 

Would you take on doing something that you knew could make a patient’s situation even worse, if you knew beforehand that you couldn’t do anything to correct it if something bad happened?  And who would be responsible if the outcome was bad? You or the patient?  Another enigma.

I guess the neurosurgeon from Israel was right about the American medical business model promoting “cut happy” surgeries that generate significant profits for their operating entities.

Interestingly, I also learned from my situation that conditions like TN are considered so rare that they are often relegated to teaching hospitals to give surgical residents training opportunities.

Even worse, regarding justice in the state of Florida where I live, one cannot sue a surgeon working for a teaching hospital. Why? Because the state owns the teaching hospitals and one cannot sue teaching hospitals owned by the state. Now, there’s a neat, circular wad of unjust enigmas further saddling the patient.

The medical enigmas abound with TN, and I suspect that’s also true with other painful conditions. So, it’s no wonder Carol chose to write about a much needed, yet disappointing pain medication that was fast-tracked to address a huge void in pain management. 

Another medical enigma that I’ll never understand: How is this whole medical approach to supposedly treating pain any different from a fox guarding the hen house?

Pat Akerberg suffers from trigeminal neuralgia, a rare facial pain disorder. Pat is a member of the TNA Facial Pain Association and is a supporter of the Trigeminal Neuralgia Research Foundation.  

Are U.S. Overdose Deaths Really Declining?

By Pat Anson

Preliminary data from the CDC suggest that U.S. overdose deaths have declined significantly, falling by 10% in the last year alone. If confirmed, the double-digit drop would mean there were 11,247 fewer drug deaths in the 12-month period ending in April 2024.

The decline, first reported by NPR, was hailed by addiction and public health experts as a hopeful sign that progress is finally being made in reducing the number of drug deaths, which have doubled in the past decade to over 100,000 a year.

“This is exciting," said Dr. Nora Volkow, director of the National Institute on Drug Abuse. "This looks real. This looks very, very real."

Good news, if it’s true. But caution is warranted about how “real” the decline is, because preliminary death data often changes as more information comes in.

Overdose data is fragmented in both quality and quantity, as it comes from 50 different sources. The data is collected by each state and then submitted to the CDC to decipher for its monthly Provisional Drug Overdose Death Count.

Some states still do not use toxicology tests to confirm whether a death is drug-related – leaving it up to medical examiners and coroners to decide which drugs, if any, may have played a role in someone dying. Some elected coroners, particularly in rural counties, have no medical training or expertise in drug death investigations. And in many cases, autopsies are not performed.

In addition to the wide variability in expertise and data collection, overdoses are typically not reported to the CDC until four months after the date of the death, sometimes longer. In its most recent provisional count, the CDC acknowledged that its overdose data may underestimate the actual number of deaths.

“Some states may have longer than usual delays in submitting drug overdose deaths. In particular, North Carolina is experiencing substantial delays in the resolution of pending records by the medical examiner’s office. Recent trends may underestimate the death count in affected states and this potential impact should be considered when comparing results for states to previous months,” the CDC said.

Percent Change in Drug Overdose Deaths (April 2023 to April 2024)

SOURCE: CDC

Reported vs Predicted

Because the provisional counts are often incomplete and the causes of many deaths are “pending investigation,” the CDC maintains two different data sets. One is the number of “reported” cases, and the other is the “predicted” number of deaths. The latter is where the 10% decline comes from.

The number of reported drug deaths is even lower than the predicted ones, suggesting there has been a 12.2% decline in overdoses nationwide. But that number is also misleading because it is based on incomplete data.

Take North Carolina, for example. For the most recent 12-month period ending in April, North Carolina reported 2,512 drug deaths, compared to 4,317 overdoses from the year before. That’s a whopping decrease of nearly 42 percent!

No one believes that number is real and will hold up over time. Not even Nora Volkow.

North Carolina is not an outlier. Reported drug deaths in Nebraska are down nearly 30 percent, but the data from there is considered “underreported due to incomplete data.” The same is true for Ohio, Pennsylvania and Michigan, where reported drug deaths are down about 20 percent. Big states like that can sway nationwide estimates.

Meanwhile, reported drug deaths are up in several western states: +42% in Alaska, +15% in Oregon, +13% in Nevada, +10% in Washington and +7% in Utah. It’s hard to square those numbers with any national trend.

“Utah’s trends haven’t aligned with national trends for some time. We plateaued while overdoses increased significantly at the national level, especially during the pandemic,” Megan Broekemeier, an overdose research coordinator for the Utah Department of Health and Human Services, told the Deseret News. “We haven’t seen statistically significant changes in the rate yet.”

‘The Dip in Overdoses Is Real’

To be fair, some of the overdose-related data is encouraging and suggest that drug deaths are in fact declining.

In a blog that tracks health data trends, Nabarun Dasgupta, PhD, a drug researcher and scientist at the University of North Carolina, reported a nationwide drop in ER visits and EMS calls (ambulance runs) involving overdoses. He estimates that non-fatal overdoses have fallen -15% to -20% nationwide

“A 15-20% decrease in non-fatal overdose and a 10% decrease in fatal overdose is a major impact. There is barely any public health intervention that has credibly achieved this magnitude of decrease,” wrote Dasgupta. “Our conclusion is that the dip in overdoses is real, and not a data artifact. It remains to be seen how long it will be sustained.”

Dasgupta attributes the decline to several possible factors, such as wider access to the overdose recovery drug naloxone and increased law enforcement seizures of illicit fentanyl.

He does not think the decline in opioid prescribing has anything to do with the drop in overdoses. Deaths linked to opioid pain medication have remained flat for nearly a decade, even as prescribing levels fell to 20-year lows.

“Let's put one hypothesis to rest: Reductions in opioid analgesic prescribing is not driving the changes in overdose rates. We've studied it, and that's not what is driving current fentanyl overdoses,” says Dasgupta.    

The CDC has a checkered history when it comes to tracking overdose deaths. When the agency released its controversial 2016 opioid guideline, it laid the blame for rising overdose deaths squarely on opioid analgesics.

“Overprescribing opioids – largely for chronic pain – is a key driver of America’s drug overdose epidemic,” said then-CDC director Dr. Thomas Frieden, a claim based on weak evidence and false assumptions.

Two years later, after millions of pain patients had their opioid doses reduced or cutoff, the CDC admitted that illicit fentanyl was driving the overdose crisis and that it mistakenly classified many fentanyl deaths as overdoses caused by prescription opioids.The death toll from prescription opioids in 2016 was nearly cut in half — from 32,445 down to 17,087 — when the deaths were reclassified as fentanyl-related.

The CDC says its data collection and analysis have improved in recent years, but they still come with a disclaimer that the monthly provisional counts “may not include all deaths that occurred” and are “subject to change.”

"I think we have to be careful when we get optimistic and see a slight drop in overdose deaths," said Dan Salter, Director of the North Carolina Office of National Drug Control Policy, told NPR. "The last thing we want to do is spike the ball."

Weak Evidence Antidepressants Treat Pain in Older Adults

By Crystal Lindell

New research shows that there’s not much evidence that antidepressants actually work at treating pain in people over 65 years old. 

The study, which comes out of the University of Sydney in Australia, is concerning because older adults with chronic pain are often prescribed antidepressants instead of pain medication. 

However, in a frustrating conclusion, the authors still do not recommend the one medication that is proven to treat pain in older adults: Opioids. 

Instead, they suggest that doctors use a “multidimensional approach using non-pharmacological strategies, such as physical exercise and cognitive behavior therapy.” 

In other words, they essentially conclude that pain patients should get no medication.

However, I am glad that more research is coming out to expose how ineffective antidepressants usually are at treating pain. That class of medication has long been held up as an opioid alternative, despite the fact that many patients don’t get much relief from them. 

The researchers found that international guidelines that recommend antidepressants for chronic pain are heavily based on studies that either exclude older adults or include only a small number of them.  

The researchers found that in the last 40 years there have been just 15 clinical trials globally that focused on the use of antidepressants for pain in older people. And many of them were industry-funded trials with fewer than 100 participants.

The authors say their research fills a much-needed information gap, by bringing together the data from these trials to look at the efficacy and adverse effects of antidepressants for acute and chronic pain in older adults..

They found a lack of evidence to support the use of antidepressants for most pain conditions – despite the fact that they are often recommended in clinical guidelines. And none of the research they analyzed looked at the effectiveness of antidepressants for acute pain, such as shingles or muscular pain.

“These medicines are being prescribed to remedy patients' pain, despite the lack of evidence to adequately inform their use,” said co-author Dr. Christina Abdel Shaheed, an Associate Professor at the University of Sydney’s Institute for Musculoskeletal Health.

The findings mirror those of a recent study in the United Kingdom, which found that there is “no reliable evidence for the long‐term efficacy of any antidepressant, and no reliable evidence for the safety of antidepressants for chronic pain at any time point." 

Withdrawal and Other Side Effects

Shaheed says the potential harms of antidepressants in older people are well documented, and should be factored into any decisions about prescribing the medications. The study found that people taking antidepressants experienced more side effects effects, such as falling, dizziness, and a higher risk of being injured. The potential withdrawal if patients abruptly stop taking antidepressants can also be severe.

The study found that duloxetine, which is sold under that brand names Cymbalta and Yentreve, was able to relieve osteoarthritis knee pain in older adults during the intermediate term, but not short-term or long-term.

As a patient who often shares my health issues publicly, I often get messages and questions from readers who are also dealing with chronic pain. Anytime they mention Cymbalta, I pause. 

I had a horrible experience trying to come off Cymbalta, and I don’t think it even helped much with my pain when I was on it. Plus, my columns about the withdrawal experience apparently resonated, because they are among the most-read, liked and commented on articles I’ve ever written. In other words, it’s not just me. 

If Cymbalta or another antidepressant does help someone, I think they should take it. But I don’t think doctors are fully transparent about how bad the withdrawal can be or how little evidence there is that they even help with pain in the first place. 

“For clinicians and patients who might be using or considering duloxetine for knee osteoarthritis, the message is clear: benefits may be seen with a little persistence, but the effects may be small and need to be weighed up against the risk,” said lead author Dr. Sujita Narayan, an Academic Fellow at the Institute for Musculoskeletal Health.

Again, I’m glad the authors are drawing attention to the problems with prescribing antidepressants for pain management. I just find it alarming that they don’t even bother to mention any alternative medications, and instead suggest non-pharmacological treatments. 

Looking back, I guess I took for granted in the early days of opioid-phobia that most people in the medical field at least recognized that giving zero medication for pain was inhumane. That often meant doctors went from prescribing opioids to prescribing antidepressants. It came with a lot of downsides for patients, but at least it was something. 

If the next stage of opioid-phobia really is just “all medications are bad at treating pain,” then things are worse than I thought. And a lot of people are going to be suffering unnecessarily. 

We already have effective treatments, we just need to use them.

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.  

Youths with Chronic Pain More Likely to Have Anxiety and Depression

By Crystal Lindell

Young people with chronic pain are more likely to suffer from anxiety and depression, according to new research published in JAMA Pediatrics.

Researchers in the U.S. and Australia reviewed 79 previous studies involving over 12,600 youths with chronic pain. The average age was about 14. Many live with chronic illnesses such as juvenile idiopathic arthritis, fibromyalgia, Crohn’s disease and colitis. 

The research team found that 34.6% had an anxiety disorder and 12.2% had depression. Those rates are more than 3 times higher than what is normally seen in a community setting.

Researchers say mental health screening, prevention and treatment should be a priority for young people with chronic pain. 

“A simple way to put this into practice would be for pain practitioners to consider a short screening assessment for symptoms of anxiety and depression in young patients,” said lead author Joanne Dudeney, PhD, a clinical psychologist and research fellow at Macquarie University in Australia.

“This is a vulnerable population, and if we’re not considering the mental health component, it’s likely we’re also not going to achieve the clinical improvements we want to see.”

The findings are surprising to me because I would have expected the rates of anxiety and depression to be even higher. Chronic pain is depressing, and it’s also natural that dealing with it would cause anxiety. Plus, the teenage years are infamous for being a hotbed of intense emotions – even for those who aren’t dealing with physical ailments. 

So if you had asked me to guess how many teens with chronic pain had depression and/or anxiety, I would have said something closer to 95 percent. It’s a wonder how anyone with chronic pain is not depressed or anxious. 

Regardless, I’m always glad to see more data like this, validating the experiences of those of us with chronic pain – especially when it comes to younger patients. Anyone who is more likely to suffer from mental health problems should be screened for them so they can get treatment.

Many doctors try to blame pain symptoms on depression and anxiety, so I always worry that research like this will somehow be used against patients. I could easily see doctors focusing on the mental health issues associated with chronic pain more than the physical ones after reading this study. 

The more hopeful scenario though is that this type of research is instead used to save lives and to make being alive easier for young pain patients. If more mental health screenings are able to prevent and treat depression, anxiety, and coping behaviors like self-harm, drug use and even suicidal ideation, that would be incredible. 

If you’re young and dealing with chronic pain, depression and/or anxiety, I want you to know that I am out here rooting for you. Your life matters in ways you can’t even fully grasp yet, and we need you to keep going. The world is a better place with you in it.

New Documentary Explores Benefits and Risks of Kratom

By Pat Anson

If you’ve heard about kratom and wondered if the herbal supplement might be useful in treating chronic pain, you’ve probably been struck by the wide range of opinions about it.  

“Kratom should not be used to treat medical conditions, nor should it be used as an alternative to prescription opioids. There is no evidence to indicate that kratom is safe or effective for any medical use,” said former FDA Commissioner Scott Gottlieb.

“Kratom has truly not only saved my life but also given me renewed hope. Without this plant I do not believe I would still be alive today,” said kratom user Kim DeMott.  

“The drug looks similar to brown powdered kratom, produces similar effects as heroin, and is primarily used… by people addicted to heroin,” reports the Ohio Substance Abuse Monitoring Network.

“Kratom does not make me high, nor do I experience side effects. I am now clear minded without the sedation caused by narcotics,” said Mary Ann Dunkel, one of the estimated two million Americans who use kratom, despite warnings that it is an “emerging public health threat.”  

If you’re confused by these diametrically opposed views, you’re not alone. Which is why Steve Hamm produced and directed a new 80-minute documentary called “The Mysteries of Kratom.”  

Hamm knew little about kratom until he started chatting with a neighbor, Dr. Marek Chawarski, a Professor of Psychiatry and Emergency Medicine at Yale School of Medicine. Chawarski spent years studying kratom in Southeast Asia, where it has been used for centuries as a natural stimulant and pain reliever.

“When Marek started talking about kratom and just the potential of it being used as an analgesic, as a painkiller, and potentially being used in dealing with opioid addiction. I got really interested,” Hamm explained. “Ultimately, we decided to make this film by asking a core question. Could a leaf of a tree in Southeast Asia help us solve this terrible addiction problem that we have in the US?”

The resulting documentary by Elm City Films is mostly self-funded and takes an even-handed, journalistic approach to the subject. You’ll hear from a grieving mother who believes her son overdosed on kratom, and a pain patient who says kratom is safer and more effective than opioids.

Hamm spent a month with Chawarski in Southeast Asia, learning how kratom is grown, cultivated and used. People there prefer using fresh kratom, either by chewing the leaves or using them to make a tea. Reports of kratom abuse or addiction are rare.

“I have not seen, nor have I heard, of any fatal overdoses from kratom in Malaysia. Non-fatal, there could be possibilities of it, but again there is no documented evidence,” said Vicknasingan Kasinather, a Malaysian professor and kratom researcher

Due to growing demand in the United States, kratom has become an important cash crop in Malaysia, Thailand and Indonesia. Most of it is dried and processed before being exported, and that processing could be where some contaminants and chemicals are first introduced.  

Once it is shipped overseas, some kratom vendors take the powder and create potent synthetic extracts using an alkaloid called 7-mitragynine, which was recently implicated by the FDA in at least one fatal overdose.

“I was recently at a trade show, where a lot of kratom products are being displayed, and I see these vendors now developing novel new products, including vape pens with 7-mitragynine that by nature are dangerous. They also have 7-mitragynine extracted powders,” said Mac Haddow, a lobbyist for the American Kratom Association. “Those should be banned from the marketplace because they are not natural, they’re synthetically derived, and that’s a real threat to the public.”

Kratom products, like other dietary supplements, are only loosely regulated by the FDA. Many kratom advocates say more regulation is needed, with testing and labeling a better alternative than an outright ban on kratom, which the FDA and DEA tried unsuccessfully to impose in 2016.

“I think the more laws there are about labeling kratom products, the better. Because then there’s more information that gets out there to the consumer,” says Brian Gallagher, a kratom podcaster.  “If it was banned everywhere, then you’d go from a grey market to a black market, where there’s no regulation. We have maybe half the companies doing the right thing. When kratom is banned, zero companies will be doing the right thing.”

Hamm hopes his documentary will help people come to a better understanding of kratom’s risks and benefits, and how a simple leaf could be a solution to some of our biggest health problems.

“We look at the science, we look at the people, we look at the legal issues and the controversies that are there. We hope you all enjoy the film, and we hope it will spark a new conversation about kratom, but also about opioids,” he said..

Study Finds Link Between Belly Fat and Chronic Pain, but Which Causes Which?

By Crystal Lindell

A new study shows a link between abdominal fat and chronic musculoskeletal pain, but even the authors admit that it’s unclear which one causes which. 

The study, published in the American Society for Regional Anesthesia & Pain Medicine, found that abdominal adipose tissue (fat) is associated with chronic pain in multiple sites and widespread chronic pain. It also found that women were at higher risk for this association than men. 

“Reducing abdominal adiposity may be considered a target for chronic pain management, particularly in those with pain in multiple sites and widespread pain," wrote lead author Feng Pan, PhD, Senior Research Fellow at the Menzies Institute for Medical Research in Australia. “The identified stronger effects in women than men may reflect sex differences in fat distribution and hormones.”

In layman's terms, they’re suggesting that chronic pain patients be told to lose weight. Especially if they are women.

However, further down in the study, while discussing its limitations, they admit that the research does not “address the issue of potential bidirectional causality.” In other words, they cannot say whether excess abdominal fat causes chronic pain, or whether chronic pain causes excess abdominal fat. 

The researchers looked at health data from 32,409 people taking part in the UK Biobank study, a large research study with half a million UK participants.

The study used MRI images to measure visceral adipose tissue (VAT), which is fat that surrounds the organs in the abdominal cavity, such as the liver, stomach and intestines. They also measured subcutaneous adipose tissue (SAT), the layer of fat that sits between the skin and muscles in the body. 

Participants were asked if they had pain in a specific area of their body or all over their body for more than three months. 

Two years later, all the assessments were carried out again in 638 people in the group.

The results showed that the more fat people carried around their abdomens, the higher their chance of reporting chronic musculoskeletal pain.

To weed out contributing factors, the researchers adjusted for many things, such as age, height, ethnicity, household income, education, alcohol frequency, smoking, physical activity, comorbid conditions, sleep duration, psychological problems and follow-up time.

While a specific link between abdominal fat and chronic pain may be new, the idea that fat could contribute to chronic pain by making people more sedentary and less likely to exercise has a long history.

However, as a patient who gained weight after developing chronic pain and being put on a number of medications that had weight gain listed as a side effect, I’m always extremely skeptical about which causes which. 

Especially because I gained and lost weight multiple times over the 11 years that I’ve been in pain, and have never noticed either one impacting my pain levels. 

In my experience, many doctors are quick to dismiss symptoms when they can blame a patient’s weight as the cause. Even when the excess weight was literally caused by medications they prescribed. 

Doctors use studies like these to blame pain patients for their problems, while absolving themselves of any responsibility to help. Patients are told their pain is their fault, and if they’d just lose weight, they’d feel better. 

Then, when losing weight proves predictably difficult, the doctor can throw up their hands at the whole situation and proclaim that the patient must not want to get better. In other words, doctors set an impossible standard for patients and then blame the patient when they fail to meet it. 

As new weight loss GLP-1 medications like Ozempic and related drugs become more popular, it will be interesting to see how they impact conversations about weight loss and chronic pain. If the medications are as good as they claim to be at helping people lose weight, we might finally get some large-scale research into how losing weight actually impacts pain levels. 

And if more patients are able to lose weight when their doctors tell them too, physicians may find that they have to do more than just tell their patients to “lose weight” when it comes to treating pain.

Cannabis Advocates Push Back on California Plan to Ban Hemp THC

By Crystal Lindell

The cannabis industry is pushing back on plans by California Gov. Gavin Newsom to impose emergency regulations that would effectively ban all food and beverage products containing Delta-8 tetrahydrocannabinol (THC) derived from hemp.

The proposed regulations would require that any products intended for human consumption have no detectable levels of Delta-8 THC or other intoxicating hemp cannabinoids; establish a minimum age to purchase hemp products at 21; and limit the number of servings of hemp products to five per package.

When hemp was legalized by Congress in 2018, the thinking was that hemp had such minimal amounts of THC that no one could possibly use it to get high. But cannabis companies soon found ways to tweak the chemical composition of hemp-derived THC and other cannabinoids (CBD) to make them more potent. Edibles containing delta-8 THC are now widely sold as candy, cookies, gummies and beverages – even in states where medical and recreational cannabis are still illegal.

“We will not sit on our hands as drug peddlers target our children with dangerous and unregulated hemp products containing THC at our retail stores,” Newsom said in a statement. “We’re taking action to close loopholes and increase enforcement to prevent children from accessing these dangerous hemp and cannabis products.”

But the advocacy group Cal NORML says Newsom’s regulations go too far and would make it impossible to sell any products containing hemp-derived CBD. It wants the rules modified to allow for non-intoxicating levels of THC. . 

“In practice, it’s impossible to eliminate detectable but non-intoxicating traces of THC from natural hemp extracts,” the group said. “THC is readily detectable at levels of 1 billionth of a gram, far below the threshold of human sensitivity.”

Cal NORML says the practical result of Newsom’s proposal would be to ban a host of hemp products that some people use to treat health conditions. It wants California to adopt Colorado’s definition of non-intoxicating hemp. That state allows hemp extracts with a CBD:THC ratio of at least 15:1 and no more than 1.75 milligrams of THC per dose. 

“There’s no danger that minors will try to get high on hemp products with less than 2 mg of THC, especially when other, much more potent marijuana products are readily available at bargain prices on the illegal market,” the group said.

“[Cal NORML] does not take issue with the regulations’ intent to block the sale of hemp products with intoxicating levels of THC in liquor stores, gas stations, smoke shops and convenience outlets, often with inadequate labeling and in a manner accessible to minors.”

As currently drafted, Cal NORML says the proposed regulations would violate the mandate of California’s medical marijuana law to provide “safe and affordable” access to cannabis for all patients in medical need.

Another advocacy group – One Hemp – is threatening a lawsuit against Newsom for exceeding his authority to enact emergency regulations without the approval of the state legislature.

“Newsom’s overreach is shameful,” said Jared Stanley, founding member of One Hemp.  “Other states have successfully banned Delta 8 products while also protecting natural hemp products through a simple solution that would safeguard ALL California’s children, not just some.”

“These rules signify that the Governor intends to turn his back on my daughter and millions in the disabled community,” says Stephanie Bohn, whose 10-year old daughter recently marked one year without seizures after she started taking natural hemp CBD.

“Governor Newsom, please acknowledge children like my daughter – the ones with intractable seizures and debilitating insomnia that conventional pharmaceuticals don't help. The only thing that offered rescue was full-spectrum CBD. This is more than a policy issue, this is a life-or-death issue.”  

One Hemp says parents of disabled children in California are “panic buying CBD products” before the proposed regulations take effect. 

The hemp rules await final approval from the California Office of Administrative Law. If they are approved, sellers of hemp products will be required to immediately impose purchase restrictions and remove items with detectable THC levels.

FDA Shutting Down Fentanyl Access Program for Cancer Patients

By Pat Anson

The U.S. Food and Drug Administration is shutting down a pain management program that helped supply fentanyl medication to patients suffering from severe cancer pain.

In a notice published on the FDA’s website for its Transmucosal Immediate-Release Fentanyl Medicines (TIRF) program, the agency said that all TIRF medications “will be discontinued” on September 30.

The program was created due to the risks associated with fentanyl, a synthetic opioid 100 times more potent than morphine. The FDA has required a Risk Evaluation and Mitigation Strategy (REMS) for TIRF medications since 2011.

“Patients currently enrolled in the TIRF REMS may continue their TIRF therapy while supplies remain,” the FDA notice states. “Prescribers currently certified in the TIRF REMS may continue to prescribe TIRF therapy for their currently enrolled patients while supplies remain but must begin working with their patients to transition to other non-TIRF treatments.”

TIRF-REMS has also stopped accepting new applications from patients, prescribers, pharmacies and wholesale drug distributors. According to the FDA, 4,722 patients received a TIRF medication in 2017, but there are currently fewer than 150 patients getting them.

Illicit fentanyl is a notorious street drug that is involved in about 70% of fatal U.S. overdoses. But prescribed fentanyl has long been an essential medicine for patients suffering from surgical pain, breakthrough pain and cancer-related pain. It is also prescribed “off-label” for other types of severe pain.

FDA TIRF-REMS UPDATE

The FDA’s decision to end TIRF-REMS came after Cephalon, which is owned by Teva Pharmaceuticals, notified the agency in August that it was discontinuing production of Actiq, a fentanyl lozenge, and Fentora, a fentanyl buccal tablet. Both medications are absorbed into the bloodstream quickly through the mouth to provide immediate pain relief.  

(Update: On September 16, FDA published a brief statement confirming that TIRF medications are being discontinued, but said the TIRF-REMS program would continue operating while supplies last.

“The TIRF REMS will remain in place as long as the manufacturers’ new drug applications or abbreviated new drug applications are approved, regardless of the marketing status of the products,” the agency said. “FDA did not request this discontinuation. It is important to note that FDA does not manufacture medicine and cannot require a pharmaceutical company to make a medicine, make more of a medicine, or change the distribution of a medicine.”

Teva did not respond to requests for comment about the discontinuations. Actiq and Fentora are expensive medications. A supply of 30 Actiq 400 mcg lozenges costs about $3,500, while 28 tablets of Fentora 100 mcg will cost about $2,300.

“I had very few patients on these medications in the past, since no health insurers would actually pay for them,” said Chad Kollas, MD, a palliative care physician and pain policy expert. “I think it’s problematic that the TIRF-REMS website isn’t offering recommendations for an effective alternative approach for the patients currently using TIRF products.”

Opioid litigation and the risk of further liability may have influenced Teva’s decision to discontinue TIRF medication. The company agreed to pay $4.24 billion to settle allegations that it illegally marketed opioids and failed to prevent their diversion.

Last year, Teva discontinued production of immediate release oxycodone as part of a strategic shift away from less profitable generic drugs.

Is the Hype About a New Non-Opioid Analgesic Justified?

By Carol Levy

In a previous column, I asked why pharmaceutical companies haven’t been able to “build a better mousetrap” by developing new and effective non-opioid medications for pain 

Every doctor I've seen about my chronic facial pain has only offered me opioids. As is true for many of us, I hate the way they make me feel. They also rarely help, outside of making me so cloudy-headed that I become less aware of the pain and have trouble thinking clearly.

That is the exact opposite of what the drug is supposed to do. It's supposed to make me feel better, and therefore better able to work, play, and do regular activities — which is exactly what the cloudiness stops me from doing. That's not a workable trade-off.

When I protest, “There must be something other than an opioid,” the reply from doctors is always the same: “There is nothing else.”

Now there may be. The FDA is giving priority review to a new drug application for suzetrigine, an experimental non-opioid analgesic developed by Vertex Pharmaceuticals. The drug has previously been granted “Fast Track” and “Breakthrough Therapy” designations by the agency for the treatment of moderate-to-severe acute pain. Final approval could come in January, which would make suzetrigine the first new class of medication for pain in over two decades.

The upside to suzetrigine is that it’s not an opioid. That would address the lie that we are responsible for the opioid crisis, and should be held captive by doctors who fear being raided by the DEA and don’t prescribe opioids anymore.

The downside is that suzetrigine is being considered as a treatment for acute pain and perhaps chronic neuropathy. My pain is neuropathic in nature -- trigeminal neuralgia and anaesthesia dolorosa (phantom pain) --- so I was at first exhilarated, and then deflated to see that suzetrigine is only being studied as a treatment for diabetic peripheral neuropathy. I had hoped this would be something for all of us.

I Google searched for other non-opioid analgesics, hoping there might be some new ones in the process of testing or even FDA fast-tracked. I couldn't find any.

As I researched further, I began to feel dejected. All drugs have downsides. That is expected. But I had hoped the FDA’s priority review meant the research was very positive about suzetrigine. Instead, I found there are many questions as to whether the drug is any better than what is already out there.

So why is the FDA fast-tracking it? Are they so eager to approve non-opioids that anything that might work will be considered? Maybe. The breakthrough therapy and fast-track designations may be geared more towards appeasing the FDA’s critics than anything else.

The headlines sounded so promising. “New Painkiller Could Bring Relief to Millions” and “A New Class of Medicine for Pain Relief On The Horizon.”

When I found out about this drug my heart leaped. Now I am not so sure. I hope it's not just another false flag. 

Carol Jay Levy has lived with trigeminal neuralgia, a chronic facial pain disorder, for over 30 years. She is the author of “A Pained Life, A Chronic Pain Journey.”  Carol is the moderator of the Facebook support group “Women in Pain Awareness.” Her blog “The Pained Life” can be found here. 

Brain Imaging Shows How Mindfulness Reduces Pain

By Pat Anson

Chronic pain patients have long been skeptical of mindfulness meditation, a form of cognitive behavioral therapy that is often touted as an alternative treatment for pain. Here are a few of the comments we’ve gotten about mindfulness over the years:

“Mindfulness is helpful. But it is only helpful when the pain is under control enough to implement it. If you are rocking back and forth from excruciating pain, any alternative therapies are useless.”

“Mindfulness may distract from pain while you are doing it. But it doesn't have any long-lasting effects.”

“Mindfulness is lazy hippie horseshit. It’s not medicine. It’s not science. It’s not therapy.”

But a new study published in Biological Psychiatry found some of the first physical evidence that mindfulness activates neural processes in the brain that help reduce pain levels. Researchers at the University of California San Diego School of Medicine used advanced fMRI brain imaging to compare the pain reducing effects of mindfulness with placebo treatments.

The study involved 115 healthy volunteers who were randomly assigned to four groups. One group participated in a guided mindfulness meditation, while the others received “sham” mindfulness that only consisted of deep breathing or a placebo cream that participants were told reduced pain. The fourth group listened to an audio book and served as a control.

The researchers then applied a painful but harmless heat stimulus (120°F) to the back of the leg and scanned the participants’ brains both before and after the interventions.

Compared to the other three groups, researchers found that mindfulness meditation produced significant reductions in pain intensity and pain unpleasantness ratings, while also reducing brain activity patterns associated with pain and negative emotions. Although the placebo cream and sham-mindfulness also lowered pain, mindfulness meditation was significantly more effective.

“The mind is extremely powerful, and we’re still working to understand how it can be harnessed for pain management,” said lead author Fadel Zeidan, PhD, a professor of anesthesiology at UC San Diego Sanford Institute for Empathy and Compassion. “By separating pain from the self and relinquishing evaluative judgment, mindfulness meditation is able to directly modify how we experience pain in a way that uses no drugs, costs nothing and can be practiced anywhere.”

Zeidan and his colleagues found that mindfulness reduced the synchronization between brain areas involved in introspection, self-awareness and emotional regulation. Those parts of the brain comprise the neural pain signal (NPS), a pattern of brain activity thought to be common to pain across different individuals and different types of pain.

In contrast, the placebo cream and sham-mindfulness did not show a significant change in the NPS when compared to controls. Instead, those interventions engaged entirely separate brain mechanisms with little overlap or synchronization.

“It has long been assumed that the placebo effect overlaps with brain mechanisms triggered by active treatments, but these results suggest that when it comes to pain, this may not be the case,” said Zeidan. “Instead, these two brain responses are completely distinct, which supports the use of mindfulness meditation as a direct intervention for chronic pain rather than as a way to engage the placebo effect.”

Researchers hope that by understanding changes in the brain associated with mindfulness, they can design more effective treatments to harness the power of mindfulness to reduce pain.

In a 2018 study of mindfulness that also induced pain through heat, Zeidan found that a part of the brain that processes thoughts, feelings and emotions – the posterior cingulate cortex -- was more active in people who reported higher pain levels. Participants with lower pain levels had less activity in that critical part of the brain.

“Millions of people are living with chronic pain every day, and there may be more these people can do to reduce their pain and improve their quality of life than we previously understood.” said Zeidan.