How Well Does Your Doctor Listen?

By Carol Levy

In addition to my trigeminal neuralgia, I also have many side effects from various surgical procedures. It’s bad enough that trigeminal neuralgia is considered a “rare” disorder, but mine is from an even more rare birth defect. Add to that facial paralysis and phantom pain, and I am a very rare duck indeed.

My cornea specialist acknowledged this recently, when I asked him about an issue with my eye.

“Most patients do fine. But there's no one else like you. So with you, I just don't know,” he said.

It’s been years since I’ve had trigeminal neuralgia “tics.” The trigeminal nerve was cut and burned surgically to stop the “tics” from occurring. But lately I've been getting new facial pain, so I asked my neurologist if the nerve could be growing back.

She shrugged her shoulders and said, “I don’t know.”

I appreciate it when a doctor is honest. They don't like to admit or show uncertainty. After all, they're the experts. They need to be able to give an answer to the question that often haunts us and sends us to them in the first place: “What is this?”

To say “I don't know” is probably very difficult for them.

Unfortunately, for many of us, instead of an honest answer, we get pats on the head and platitudes: “It's anxiety. Calm down and relax. Your pain will get better.”

Sometimes we get disbelief: “I don't believe you have pain. Your story isn't right.”

Some basically tell us to go away and not bother them anymore.

And then doctors wonder why patients have lost trust in them.

Patients complain rightfully when a doctor spends most of the appointment on the phone or looking at their laptops. Sometimes, if they bother to look up, they’ll say, “I'm looking into a medication I think may help.” 

Okay, that's good. He's researching so he can prescribe the right thing. But couldn't he have said something before he turns to his phone?

“I need to do some research,” the doctor could say. “I want to be sure I have the right diagnosis and prescribe the right drug. I can call you or see you again if necessary.”

I might be annoyed by that. After all, I'm leaving the office with no diagnosis or prescription. But it's preferable to the wrong diagnosis or the wrong medication. Waiting for the phone call or going back to the office to get what I need is preferable to being treated for the wrong thing or with a medication that doesn't work.

But it doesn't negate the feeling that "he never looked at me."

This has gotten worse in the digital age. They don't look at us, they are often more focused on the computer. Supposedly that helps them take notes and write a thorough report as they conduct an exam. But how many times have you seen the report? Is it rife with errors, things you never said, or exams never done?

I have read a number of articles that put the blame for this on the insurance companies. They require all health records to be stored electronically (EHR), so a doctor has to look at his computer.

But, having to comply with that requirement does not impose an inability to look your patient in the eye, to show interest, empathy and caring. That is not the insurance company's mandate. That should be the mandate for good doctoring

I’ve also seen articles where the blame is placed on the media. They only report on the bad doctors, never the good ones.

I have never imagined my doctor wearing a magical cape or having phantasmagorical powers. I could care less what the media shows. I only care about my doctors and how honest they are with me.

Sadly, too many of them are encased in an armor that pushes us away, that makes us distrust them. It’s the turnabout of the old breakup adage: It's not me, it's you.

Carol Jay Levy has lived with trigeminal neuralgia, a chronic facial pain disorder, for over 40 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.  

Awake, Not Woke: How Politics in Medicine Harms Patients

By Dr. Lynn Webster

Somewhere between facts and social media, “woke” -- a perfectly good word for being awake to reality -- got transmogrified into a slur. If that alchemy puzzles you too, consider this brief field manual for the Anti-Alarm-Clock Caucus: a how-to on mistaking earplugs for policy and empathy for extremism.

Culture-war rhetoric chills evidence-based care and worsens outcomes. Let me explain what we should do instead. 

If you’ve ever sat with someone who was in real pain, you know how brittle the anti-woke script sounds in exam rooms. Patient-centered conversation becomes suspect; motivational interviewing gets mocked as coddling; and a clinician trying to tailor a taper to a patient’s specific needs is accused of ideology.

The risk isn’t a bruised ego -- it’s disengagement. People clamp down, under-report substance use, skip follow-ups, and show up again only when they’re much sicker.

The irony is stark: even the critics who rail at “woke medicine” still rely on the public health infrastructure they deride when it’s time to manage the fallout.

Here’s the magic trick they perform: They rebrand attentiveness as excess and turn “be aware of harm” into “behold the woke mind virus.” Once they frame awareness as contagion, politicians can sell indignation like energy drinks. Any medical practice that looks like it’s noticing the individuality of a patient -- bias training, person-first language, or trauma-informed care -- gets dismissed as ideology, rather than craft.

Because they like to think of themselves as honorable, they follow a set of prescribed rules including:

Rule #1: Relabel Compassion as “Coercion”

When a clinic swaps “addict” for “person with a substance use disorder” because it reduces stigma and improves engagement, they accuse the “word police” of forcing the change in nomenclature. Opposing any sign of empathy requires less energy than reading the literature and seems far more satisfying than measuring outcomes.

If they made the effort, they would know that the National Institute on Drug Abuse (NIDA) advises using person‑first, non‑stigmatizing language -- e.g., “person with a substance use disorder” rather than “addict” -- to reduce bias in clinical care.  

In fact, in the International Journal of Drug Policy, John Kelly and Cassandra Westerhoff reported that the term “substance abuser” prompts more punitive judgments against the patient, even when trained mental health professionals are involved.

Rule #2: Recode Lifesaving Tools as Culture War

Naloxone, syringe services, and overdose prevention centers are tedious in one way: they work. So, label them “woke enabling” and starve them of funding. It saves leaders from saying the quiet part out loud -- “I oppose what works” -- while ensuring the body count stays offstage.

The CDC reports that Syringe Services Programs (SSPs) are “safe, effective, and cost-saving” and “do not increase illegal drug use or crime.” Access to and disposal of sterile syringes that won’t be reused is associated with a 50% reduction in HIV/HCV incidence. The reduction exceeds two‑thirds when combined with medications for OUD. HHS adds that harm reduction is “critical to keeping people who use drugs alive.”

In Massachusetts, communities implementing overdose education and nasal naloxone distribution (OEND) programs saw a 27% lower opioid overdose death rate at modest program scale and a 46% lower death rate at higher scale compared to communities without OEND.

Rule #3: Flatten Complexity Into Blame

Fentanyl potency, housing collapse, and workforce shortages are complex, unglamorous problems. “Woke drug policy failed” fits easier on a bumper sticker.

When Oregon struggled amid a fentanyl wave, the vibe merchants -- outrage marketers who sell mood over evidence -- declared drug decriminalization to be the villain.

But nuance seldom survives a fact check. The best evidence to date is that Oregon’s decriminalization of small amounts of drugs in 2020 was not associated with an increase in fatal overdoses after accounting for fentanyl’s spread. Oregon later recriminalized possession in 2024, even though state health officials reported a 22% decrease in overdose deaths in the prior year.

On the street, cruel rhetoric cues policy. Call overdose prevention centers “ideological” and it becomes simpler to shutter them than to count the lives they save. Smear syringe services as permissive, and you can cut programs that prevent HIV and hepatitis C, while claiming fiscal prudence.

Mock “harm-reduction spending” and you can bury the line item without ever debating the outcomes. From 2019 to 2022, New York City’s Opioid Prevention Centers (OPCs) resulted in no significant increases in violent or property crime, 911 calls, or 311 calls for drug use after opening.

Similarly, Vancouver, Canada reported a 35% reduction in overdose mortality rates after the opening of North America’s first supervised injecting facility.

Inside healthcare systems, the anti-woke script causes harm. Clinicians already practicing under surveillance and time pressures learn to avoid nuance with patients, resulting in less motivational interviewing, fewer shared decisions, and more default suspicion. The clinical vocabulary hardens, and patients pick up on it the way they would the weather.

When language gets sharper, so do consequences -- patients disclose less, absorb less, and leave treatment sooner. NIDA’s guidance exists precisely to counter those effects.

The Anti-Theatrical Fix: What Actually Works

The fix is simple. The antidote to anti-woke drama is being awake.

Call things what they are: naloxone reverses overdoses, syringe programs prevent infections, and supervised drug consumption reduces death and connects people to care. That’s not a worldview, it’s reality.

Use words that keep doors open instead of closing them. Person-first language is stigma hygiene, not a lifestyle brand. Judge policies by outcomes and timelines rather than outrage cycles. If the curve bends where capacity expands and supply is stabilized, then fund capacity and stabilize supply.

Retire spin peddlers as culture-war props. Federal judges noted that an anti-woke law in Florida crossed constitutional lines, ruling that “viewpoint discrimination is inherent in the design and structure of this Act.”

We could even try a fascinating (or, perhaps, boring to some) experiment in courage: let leaders earn applause for actions that quietly work, instead of things that loudly sting. Pay clinicians for patient-reported function, not for performing moral panic. Reward programs that shrink infections and deaths, not those that inflate arrest numbers. And when someone tries to sell you an anti-woke policy branded as “toughness,” ask to see the data, the denominator, and the deaths averted.

If you need a slogan, Gov. Ron DeSantis already gave you one and it just proves the point: “We will never surrender to the woke mob. Florida is where woke goes to die.”

None of this requires everyone to be “woke” or to join a mob. It requires us to be awake. The linguistic jujitsu that turned woke into a boo-word lets leaders score easy points, while patients lose hard chances.

You can see the toll in the quiet statistics, but you can also hear it in the voices that don’t come back, including the patient who won’t return after being called an unkind name; the parent who stops carrying naloxone because a lawmaker sneered at “harm-reduction spending”; and the person who overdoses in a locked bathroom because a supervised site was branded as “ideology.”

Be awake to patients and outcomes; let data, not drama, guide healthcare.

Lynn R. Webster, MD, is a pain and addiction medicine specialist and serves as Executive Vice President of Scientific Affairs at Dr. Vince Clinical Research, where he consults with pharmaceutical companies. He is the author of the forthcoming book, “Deconstructing Toxic Narratives–Data, Disparities, and a New Path Forward in the Opioid Crisis,” to be published by Springer Nature. Dr. Webster is not a member of any political or religious organization.

Medical Cannabis Helps Insomnia Patients Sleep and Reduces Pain

By Pat Anson

Insomnia patients taking medical cannabis reported better sleep quality, as well as less anxiety, depression and pain, according to a new study published in PLOS Mental Health.

The study is notable because it showed sustained improvement in symptoms over 18 months of treatment with medical cannabis. Most previous studies are much shorter.

Researchers at Imperial College London followed 125 patients diagnosed with an insomnia disorder who were prescribed medical cannabis and enrolled in the UK Medical Cannabis Registry. Participants either ingested cannabis oil, smoked dried flower, or a combination of the two. Improvements in sleep and other symptoms were observed after one month of treatment and continued over the 18-month course of the study.

However, the magnitude of improvement declined over time, suggesting that some patients developed tolerance to cannabis. Less than 10% of patients reported mild side effects, such as dry mouth, insomnia and fatigue.

“Over an 18-month period, our study showed that treatment for insomnia with cannabis-based medicinal products was associated with sustained improvements in subjective sleep quality and anxiety symptoms. These findings support the potential role of medical cannabis as a medical option where conventional treatments have proven ineffective,” said co-author Simon Erridge, a PhD candidate at Imperial College and Research Director at Curaleaf Clinic, a cannabis dispensary.

“Conducting this long-term study provided valuable real-world evidence on patient outcomes that go beyond what we typically see in short-term trials. It was particularly interesting to observe signs of potential tolerance over time, which highlights the importance of continued monitoring and individualised treatment plans.”

The researchers say larger clinical trials are needed to confirm their finding of long-term efficacy. Most of the researchers are either employees or medical practitioners at Curaleaf Clinic.

A previous study conducted in Israel also found that cannabis helps with sleep, but regular use lead to drug tolerance and even more sleep problems. Over time, the benefits of cannabis were reversed, with frequent users finding it harder to fall asleep and waking up more often during the night.  

Brains Control Pain Differently, Depending Where It’s Felt

By Crystal Lindell

Different parts of the brain are more active when relieving pain — depending on where the pain originates — according to a new Australian study. The finding could lead to more targeted and effective treatments that utilize the body’s own pain relief system.  

Researchers  at the University of Sydney made the discovery while studying the placebo effect. They used MRI brain scans to monitor 93 healthy participants, while exposing them to painful heat on various parts of the face, forearm and leg. 

Before the test, participants were given a placebo analgesic cream and told it would help relieve their pain. In reality, the “lidocaine” cream was a placebo and researchers secretly lowered the temperature of the heat, tricking the participants to believe the cream was easing their pain. 

The heat stimulus was applied to the placebo-treated area, as well as a separate untreated area for comparison. Up to 61% of participants reported less pain in the area where the cream was applied, typical of a placebo response.

The MRI scans showed how the brain responded to the placebo effect. Researchers found that upper parts of the brainstem were more active when relieving facial pain, while lower regions of the brainstem were engaged for arm or leg pain. 

“This is the first time we’ve seen such a precise and detailed pain map in the human brainstem, showing us that it tailors pain relief to the specific part of the body that’s experiencing it,” lead author Lewis Crawford, PhD, a Research Fellow at the University of Sydney, said in a press release. 

Understanding which brainstem areas are linked to different parts of the body may open new avenues for developing non-invasive therapies that reduce pain.   

“The brain’s natural pain relief system is more nuanced than we thought,” said Crawford. “Essentially, it has a built-in system to control pain in specific areas. It’s not just turning pain off everywhere; but working in a highly coordinated, anatomically precise system.”     

“We now have a blueprint for how the brain controls pain in a spatially organised way,” said senior author Luke Henderson, PhD, a Professor in the School of Medical Sciences and the Brain and Mind Centre. “This could help us design more effective and personalised treatments, especially for people with chronic pain in a specific area of their body.”

It is important to note that none of the “healthy” participants had chronic pain, and thus these results may only apply to short-term, acute pain that is treated with a placebo.

Nevertheless, the study challenges long-held assumptions about how pain relief works. Instead of relying on medications that target opioid pain receptors in the brain, researchers say receptors in the brainstem could be targeted with cannabinoids. 

“Opioid-based pain relief typically activates central areas of the brain and can affect the whole body, whereas the cannabinoid circuit that we identified appears to operate in more targeted regions of the brainstem,” said Crawford. “This supports the idea that cannabinoids may play a role in localised, non-opioid pain control.”

Most oral pain medications today – including acetaminophen, ibuprofen and opioids – work by telling the brain to relieve pain throughout the entire body. This research opens the door to more targeted therapies that relieve pain in specific parts of the body.

Top Officials at CDC Resign After Director Fired in Dispute Over Vaccines

By Pat Anson

CDC Director Susan Monarez has been fired by President Trump, capping a week-long drama that began with Monarez refusing to make changes in vaccine policy ordered by Health and Human Services Secretary Robert F. Kennedy Jr.  At least four top CDC officials resigned in protest after Monarez was ousted, creating further chaos at the country’s top public health agency.   

“The agency is in trouble, and we need to fix it, and we are fixing it, and it may be that some people should not be working there anymore,” Kennedy told Fox News.

Kennedy, a longtime critic of vaccines, demanded that Monarez resign or be fired, and she refused. Monarez had been acting CDC director since President Trump took office and was confirmed by the US Senate only a month ago.

Attorneys for Monarez say she could only be fired by the president and accused Kennedy of “weaponizing public health for political gain” by dismissing CDC scientists and appointing vaccine skeptics to CDC advisory committees.

“When CDC Director Susan Monarez refused to rubber-stamp unscientific, reckless directives and fire dedicated health experts, she chose protecting the public over serving a political agenda. For that, she has been targeted,” attorneys Mark Zaid and Abbe Lowell said in a statement. “The attack on Dr. Monarez is a warning to every American: Our evidence-based systems are being undermined from within.”

Tensions have been rising at the CDC for months after steep cuts in its staff and budget, followed by the overhaul of advisory panels ordered by Kennedy.

Recently, a gunman angry about Covid vaccines fire hundreds of shots at CDC headquarters in Atlanta, killing a policeman and traumatizing employees. Both President Trump and Kennedy were notably silent after the attack, which only made morale worse.  

More than 750 HHS staffers signed a letter saying the Trump administration “failed to adequately respond” to the attack and that Kennedy was “endangering the nation’s health by repeatedly spreading inaccurate health information.”

‘This Is a Heartbreaking Decision’

The four high-ranking CDC officials who resigned are Dr. Debra Houry, the CDC’s deputy director and chief medical officer; Dr. Demetre Daskalakis, who headed the center that makes vaccine recommendations; Dr. Daniel Jernigan, who oversaw vaccine safety; and Dr. Jennifer Layden, who was in charge of the CDC’s public health data. Kennedy recently pressured the agency to share health data for a study to confirm his beliefs that vaccines cause autism.

“This is a heartbreaking decision that I make with a heavy heart,” Houry said in an email to colleagues.

When she started at CDC over a decade ago, Houry was director of the CDC’s National Center for Injury Prevention and Control, which oversaw the secretive drafting of the agency’s controversial 2016 opioid guideline. Critics say anti-opioid activists had too much influence on the guideline and accused then-CDC Director Thomas Frieden of “blatant violations” of federal advisory committee laws.

Although the guideline was voluntary, it was so widely implemented by doctors that it caused “serious harm” to pain patients who were tapered to lower doses or no longer able to get opioid medication. Many suffered through withdrawal, uncontrolled pain, psychological distress and, in some cases, suicide.

Things got so bad, the CDC revised its guideline in 2022 to give doctors more flexibility in prescribing opioids. By then, Houry had left the Injury Center and been promoted to chief medical officer.

“From a very narrow viewpoint, some might take comfort in the resignation of Debra Houry as chief medical officer of CDC. Prior to holding that position, she had been Tom Frieden's action arm for implementing the original opioid guidelines. However, like Frieden, she also had a history of positive accomplishments and her current resignation appears to be a laudable matter of principle,” said Dr. Charles LeBaron, a retired CDC epidemiologist.

LeBaron wrote a book critical of the agency’s guideline and its leadership: “Greed to Do Good: The Untold Story of CDC’s Disastrous War on Opioids.” He says the current turmoil at CDC and HHS is likely to disrupt other public health efforts besides vaccines.  

“This is a developing situation in which efforts to address both pain and addiction treatment matters are really suffering collateral damage in a war over vaccines and related matters of public health,“ LeBaron told PNN in an email. “Whatever happens, it's hard to imagine that RFK Jr, with his ‘healing farms’ approach to eliminating opioid use, is ever going to make matters better in this area. 

“Until we get a sane person in charge of HHS, it's hard to see how anything useful in any area, including pain treatment, is going to happen. If you want my opinion, the more that the pain treatment community (along with everybody else) can successfully urge for RFK Jr's replacement, the more likely we are to see some progress at some point, rather than the current headline-de-jour chaos.”

The most immediate impact of the turmoil at CDC is uncertainty and delay in the release of the updated 2025-2026 Covid vaccines. Earlier this week, the FDA approved the use of new vaccines made by Pfizer, Moderna and Novavax, but limited who can get them to older Americans or those with a high-risk health condition. Several states are reporting a surge in Covid infections caused by a new Omicron variant.

FDA approval will be enough for some states to begin offering the new Covid vaccines, but other states will wait for a recommendation from the CDC’s new advisory panel, which now includes doctors and researchers who have publicly questioned the safety of vaccines.

The Advisory Committee on Immunization Practices is scheduled to meet September 18-19. According to the agenda, the panel will discuss many common vaccines, including those for COVID-19, hepatitis, measles, mumps, and rubella. The panel will consider whether to “revise the list of vaccines for administration to vaccine-eligible children.”

What Having Chronic Pain Teaches You About Doctors

By Crystal Lindell

There’s an old story often shared in my family about my great uncle Jim. It’s a story I’ve heard since I was a kid, as a warning. 

You see, when Jim was 39 years old, he was told to take “heart medication.” 

But Jim felt fine, so he ignored the doctor’s orders and never took the pills. And then, one night, while his wife – my aunt Sylvia – was watching TV, Jim went upstairs, fell asleep and died. He never even made it to his 40th birthday. 

I never met Jim, but his early and unexpected death sent shock waves through generations of my family. And his story eventually morphed into family folklore, where the moral was that if a doctor gives you medication, you need to take it. 

It is with this mindset that I first approached my doctor appointments back in 2013 when I developed chronic pain in my right ribs. 

I didn’t know the cause – and to be honest, I still don’t really know for sure how it started – but I did know that I was in a lot of pain, and I was very scared. 

So when the doctors started loading me up with prescriptions, I filled every single one of them. Within a couple months, I had a line of pill bottles and patches on my nightstand spanning everything from gabapentin and amitriptyline to lidocaine and other medications I can’t even remember now. 

And I took all of them exactly as prescribed. 

The only problem was, the lessons of the past did not apply to my situation. The medications were prescribed by a team of doctors who were just throwing stuff at the wall to see if anything would stick. 

Taking them in combination caused horrible side effects. I was always on the verge of falling asleep, and I started gaining weight so fast that my clothes would stop fitting in the span of a week. 

Not to mention the fact that they also weren’t even doing the one thing I needed: None of them were helping my chronic pain. 

It wasn’t until I eventually went to the Mayo Clinic about a year later that I realized the flaws in my logic.

It was there that a doctor told me to just stop taking half the medications I was on. When I questioned her, she was shocked that I had not thought to stop any of them sooner. 

It sounds naive in retrospect, but that was the first time I started to realize that doctors were not gods. And that doctors are sometimes guessing when it comes to treatments.

It was a lot to process, because it also meant that I had to reckon with the fact that I could no longer just blindly follow whatever treatment they were giving me. Rather, I was going to have to figure out a lot of this for myself. 

There’s a common myth that if you ever get sick, a doctor will save you. But when you develop any sort of chronic health condition, you realize that doctors are just humans too. They come into appointments with prejudices, egos, bias, and flawed information. They also often disagree with other doctors.

This can be extremely difficult to navigate because when it comes to your health, a lot of treatments really are about life or death. And filtering out which ones are life and which ones might be death is dangerous business. Doctors are definitely needed to guide us, but they can’t be relied upon to do it alone. 

There’s an old saying about doctors: “There’s a reason they call it a practice.” Even doctors are still learning about the complexity of our bodies. Because as I said, they are not gods, and as such, they can’t be relied upon to be our saviors. 

In the end, we have to save ourselves. 

It’s not quite as comforting to see the world that way, with the knowledge that nobody is coming to save us. But it’s more realistic. And a lot more likely to actually save you. 

Ohio Governor Seeks Ban on All Kratom Products

By Pat Anson

Ohio Governor Mike DeWine wants his state to immediately ban the sale and use of all natural and synthetic kratom products by designating them as illegal Schedule One controlled substances, on the same level as heroin and LSD. DeWine is also seeking bans on “all existing and future synthetic kratom compounds.” 

If approved by the Ohio Board of Pharmacy, stores and other businesses in the state would be required to remove all kratom edibles, powders and drinks from their shelves and stop selling them online.

Kratom comes from the leaves of a tree that grows in southeast Asia and has been used for centuries as a natural stimulant and pain reliever. In recent years, millions of Americans have discovered that kratom can be used to treat pain, anxiety, depression and addiction.

The FDA, however, has not approved kratom for any medical condition. The agency recently warned that synthetic kratom products boosted with concentrated forms of the kratom alkaloid 7-hydroxymitragynine (7-OH) could cause addiction and overdoses, and should be classified federally as Schedule One drugs by the DEA.

“These modified kratom products, sold online and in stores, are essentially legal, over-the-counter opiates that anyone – including kids – can buy with just a few bucks,” Gov. DeWine said in a press release.

“There is no accepted medical use for kratom in Ohio, and it is an imminent public health risk. The Ohio Board of Pharmacy should act with urgency to schedule all kratom compounds and future alterations of them as Schedule I illegal drugs.” 

This isn’t the first time the Ohio Board of Pharmacy will consider banning kratom. In 2018, the board voted to classify kratom as a Schedule One drug after receiving a report from the Ohio Substance Abuse Monitoring Network blaming kratom for several deaths and falsely claiming that people were injecting kratom like it was heroin. The board later rescinded its decision after a public outcry.

Another public outcry is likely, judging by the early reaction to DeWine’s proposal on X/Twitter.

“This is not good! Do you want to help patients with uncontrolled pain get their pain medicine doctors back? Because they quit prescribing,” said one poster. “Some have now found relief with Kratom and you want to take this away?”

“Prohibition of both plain-leaf kratom and 7-OH extracts is a bad thing. In both cases, they will lead to people turning to more dangerous opioids,” said another. “Kratom, particularly the pure leaf powder, is incredibly safe, pretty much impossible to have a lethal overdose. Mike DeWine is putting hundreds of thousands of people in his state at risk.”

“Our system has already turned their back on people suffering from chronic pain, disregarding their quality of life. Now the government wants to have us suffer more. This is total bull,” wrote another poster.

Under existing Ohio state law, kratom can only be sold in its natural, dried leaf or powdered form. Selling synthetic or adulterated kratom is also illegal.

Despite those safeguards, the Ohio Department of Health says kratom was found to be a cause of death in more than 200 overdose deaths in the state from 2019 to 2024.

Earlier this month, Florida Attorney General James Uthmeier filed an emergency rule classifying concentrated forms of 7-OH as a Schedule One controlled substance in Florida. Gov. DeWine’s proposal would go much further than that, by classifying all kratom products – including natural leaf kratom – as Schedule One drugs.

Alabama, Arkansas, Indiana, Rhode Island, Vermont and Wisconsin have already classified kratom as a controlled substance. Dozens of cities, counties and local jurisdictions have also banned its sale.

While hundreds of deaths in the US have been linked to kratom use, most cases involve other drugs and illicit substances, making it difficult to determine the exact cause of death or any liability.

In a playbook reminiscent of the campaign against opioid pain medication, several law firms are seeking plaintiffs allegedly harmed by kratom to participate in class action lawsuits against kratom vendors and wholesalers.    

A former CDC director recently said that natural leaf kratom caused “no serious adverse events“ to patients involved in an FDA study, but agreed that synthetic kratom should be scheduled as an illegal drug.

“Natural kratom leaf, when used as it has been for centuries, presents a markedly different risk profile than the synthetic products flooding American markets,” said Robert Redfield, MD. “Full spectrum kratom, used responsibly, appears to have acceptable safety margins based on FDA’s own clinical data.”  

(Update 8/27/25: The Ohio Board of Pharmacy cancelled a special meeting scheduled for Wednesday to make an emergency move to ban kratom. No explanation was made as to why the meeting was cancelled.)

FDA Approves First Implant That Zaps Rheumatoid Arthritis

By Madora Pennington

A nerve stimulation implant recently approved by the FDA reduces symptoms of rheumatoid arthritis by stimulating the vagus nerve with mild electronic pulses. It’s the first FDA-approved neuromodulation device for adults with moderate-to-severe rheumatoid arthritis (RA).

The vagus nerve stimulator (VNS), created by SetPoint Medical of Valencia, California, is the size of a coffee bean. It is implanted in the left side of the neck under anesthesia during an outpatient procedure.

The device delivers electronic pulses into the vagus nerve for just one minute each day to calm the immune system and have an anti-inflammatory effect. RA causes the immune system to attack the lining of joints, damaging cartilage and eroding bone.

“The approval of the SetPoint System, the first-in-class neuroimmune modulation platform, represents a transformative milestone in the management of autoimmune diseases,” Murthy Simhambhatla, PhD, CEO of SetPoint Medical, said in a press release. “We plan to introduce the SetPoint System in targeted U.S. cities this year, followed by expansion across the country starting in early 2026.”

In auto-immune diseases like RA, the function of the vagus nerve becomes impaired. The nerve starts in the brainstem and runs through the neck, chest and abdomen, where it branches out into many organs.

The vagus nerve helps regulate the nervous system, including heart rate, blood pressure, respiration and digestion. When the nerve malfunctions, it causes inflammation and disrupts the immune system.

In a clinical trial of 242 patients, just over half (51.5%) had at least a 20% improvement in RA symptoms after 24 weeks with the SetPoint implant. Most patients tolerated the device well, but two experienced side effects of vocal cord weakness and hoarseness.

SETPOINT MEDICAL IMAGE

The SetPoint System is intended for RA patients who have not benefited from medications designed to calm the immune system, known as Disease-Modifying Antirheumatic Drugs (DMARDS) or the much stronger biologics that target specific immune cells. Doctors can monitor the device with an iPad application and patients can recharge it themselves with a wireless charger.

Vagus nerve stimulation is not new. In 1997, the FDA approved VNS for epilepsy. The implanted device is installed in the chest like a pacemaker to reduce seizures or even stop ones in progress.  

VNS can also treat chronic pain, by helping the brain "turn down" pain signals and reduce pain indirectly through its anti-inflammatory effects.  

Other types of pain for which VNS has demonstrated effectiveness are chronic migraine, chronic primary headache, cluster headache, fibromyalgia, chronic pancreatitis, esophageal pain, irritable bowel syndrome, neuropathic pain, musculoskeletal pain, osteoarthritis, and chronic low back pain.

SetPoint is investigating whether its technology can also treat multiple sclerosis, Crohn's disease and other autoimmune conditions.

Rising Health Insurance Costs Should Cause Americans More Alarm

By Elisabeth Rosenthal, KFF Health News

Wary of inflation, Americans have been watching the prices of everyday items such as eggs and gasoline. A less-noticed expense should cause greater alarm: rising premiums for health insurance. They have been trending upward for years and are now rising faster than ever.

Consider that, from 2000 to 2020, egg prices fluctuated between just under $1 and about $3 a dozen; they reached $6.23 in March but then fell to $3.78 in June. Average gas prices, after seesawing between $2 and $4 a gallon for more than a decade starting in 2005, peaked at $4.93 in 2022 and recently fell back to just over $3.

Meanwhile, since 1999, health insurance premiums for people with employer-provided coverage have more than quadrupled. From 2023 to 2024 alone, they rose more than 6% for both individuals and family coverage — a steeper increase than that of wages and overall inflation.

For many people who have the kind of insurance plans created by the Affordable Care Act (because they work for small companies or insure themselves), rates have probably risen even more drastically. In this market, state regulators scrutinize insurers’ proposed rate increases, but only if they exceed 15%.

And the situation is about to get worse: For 2026, ACA marketplace insurers have proposed eye-popping new prices: In New York, UnitedHealthcare has proposed a 66.4% rise. HMO Colorado has asked for an average increase of more than 33% in that state. In Washington, the average proposed increase across all insurers is 21.2%, and in Rhode Island it’s 23.7%.

According to Business Group on Health, a consortium of major employers, “actual health care costs have grown a cumulative 50% since 2017.” In a separate survey published in 2021, 87% of companies said that in the next five to 10 years, the cost of providing health insurance for their workers would become “unsustainable.”

And insurers in the ACA marketplace are increasing premiums by an average of 20% for next year, according to a new analysis. Imagine if tens of millions of Americans’ rent or mortgage payments were to suddenly increase by that amount.

Insurance regulators theoretically could demand that these proposed rates be lowered — and this often happens. But some states are more active than others in this regard. And all are wary that too much regulatory interference could drive insurers from their markets.

Insurers offer many explanations for their calculations, some of which are tied to recent actions by Congress and President Donald Trump. New tariffs on America’s trading partners, for example, are expected to push up the cost of drugs and medical supplies.

Meanwhile, reductions in health care spending included in the GOP budget bill, along with the expiration of some Biden-era premium subsidies at the end of this year, will cause many people to lose their health insurance. About 16 million Americans are expected to become uninsured by 2034, in many cases because keeping insurance will become unaffordable.

Because most of these people are likely to be young and/or healthy, the “risk pool” of those remaining insured will become older and sicker — and therefore more expensive to cover.

“Ultimately, we believe the ACA market will likely be smaller and higher acuity-driven next year,” Janey Kiryluik, vice president of corporate communications for Elevance Health (formerly known as Anthem), wrote in an email. She added: “Our position reflects early disciplined action.”

Remember, most insurers in the United States are public, for-profit companies; as such, they tend to act in the interests of their shareholders, not the patients whose health care they cover.

Large employers that manage their own health care plans might be able to negotiate better deals for their workers. But smaller companies, for the most part, will need to accept what’s on offer.

Premiums are not the only part of health insurance that’s getting more expensive. Deductibles — the money that beneficiaries must spend out-of-pocket before insurance kicks in — are also rising. The average deductible for a standard ACA silver plan in 2025 was nearly $5,000, about double what it was in 2014. (For those with employer-based insurance, the average number is just under $2,000.)

A few states are trying to stem the tide by offering a state-run “public option,” a basic affordable insurance plan that patients can choose. But they have struggled because a lower payment rate for workers generally means fewer participating providers and reduced access to care.

If voters paid as much attention to the price of health insurance as they do to the cost of gas and eggs, maybe elected officials would respond with more action.

KFF Health News is a national newsroom that produces in-depth journalism about health issues.

Back Pain Will Cost Australia Billions, but Rx Opioids Dismissed as a Remedy

By Crystal Lindell

A new study is sounding the alarm about lost worker productivity in Australia caused by chronic back pain, but an inexpensive remedy is being dismissed as “low-value or harmful.” 

Published in JAMA and led by researchers at Monash University, the study projects massive losses in productivity in Australia caused by long-term back pain. In 2024, nearly 3 million Australians had chronic back problems. That’s projected to grow to nearly 3.3 million by 2033.

The researchers estimate that back problems will result in an estimated loss of 3.4 million productivity-adjusted life-years over a 10-year period. That equates to a loss of more than $638 billion in Australian dollars in the country’s gross domestic product. That’s about $414 billion in US dollars.

That’s a lot of lost productivity and money. Just a 10% reduction in the number of workers with long-term back problems would save over $41 billion Australian dollars 

“Substantial economic gains could be achieved from reducing the prevalence and impact of the condition,” wrote lead author Sean Docking, PhD, a health economist at Monash University. “Action is needed to reduce the prevalence and burden of long-term back problems, with a focus on better-quality care and supporting people of working age to remain in the workforce and working productively.”

Indeed, there is a need to reduce the “impact of the condition.” I completely agree. However, while the authors call for interventions, they ignore an obvious tool that used to be widely available in Australia until 2018: codeine. 

That’s when Australia made codeine available by prescription only. Until then, the opioid was sold over-the-counter, and no doubt was often used to help people with back pain get out of bed, go to work, and be more productive.

While pop culture has often crafted a view that opioid medications are sleep inducing and that people who take them are lazy, the reality is that millions of people take them so that they can work and be productive. That’s especially true for mild, low-risk opioids like codeine.

The Monash researchers also point out that calling in sick and working less creates “considerable financial stress and may disproportionally impact already disadvantaged communities.”

Again, I agree. Not being able to work because of chronic pain can definitely result in a huge financial burden. And effectively treating that pain can literally make it possible for people to continue working and not rely on public assistance programs.

Unfortunately, rather than addressing this or offering practical solutions, the researchers dismiss all opioids as a “low-value” care option. Instead, they recommend “high-value” care, which basically consists of vague advice to “stay active” and get back to work as soon as possible. 

“A major way of addressing the burden of long-term back problems is to reduce the proportion of individuals who receive low-value or harmful care,” researchers said. “However, contrary to evidence-based guidelines, low-value care is prevalent. Examples of low-value care have been associated with longer absences from work. By contrast, high-value care could prevent chronicity, improve patient health outcomes, and result in productivity gains that benefit society.”

Perhaps the use of opioids is associated with “longer absences” because the pain medications are only given out when patients have severe back pain and really should stay at home.

It’s frustrating that, like many pain studies these days, the Monash researchers found a way to work in a negative view of opioids and suggest that they don’t “benefit society” or improve patient health.  

The fact that they left out how the crackdown on opioid prescribing contributes to lost productivity is also disheartening, especially when opioids are an inexpensive remedy.

When people have adequate pain relief, they can be productive. When they don’t, they can’t. Chronic pain patients understand this. Now we just need medical professionals to understand it too.

The Strange Denial of Complications Caused by Poorly Treated Pain

By Drs. Forest Tennant and Scott Guess

There has been no shortage of controversy, scandal and fraud regarding the opioid and pain crises of the past decade. One standout in the debate over opioids and pain treatment has been a lack of an honest, objective discussion of the benefits of pain care.

A basic tenet in medical practice and therapeutics is what is called the “risk-benefit” ratio. This is a simple analysis of whether a specific drug or therapeutic measure has more benefit than risk.

For example, the risk-benefit of drugs taken during pregnancy is well-known and established. But strangely, the debate over whether opioids have more benefit than risk in the treatment of pain has never been broached.

None of the parties involved, especially the anti-opioid zealots, will discuss any benefit that opioids may bring. In fact, essentially their only discussion is that opioids are a risk for overdose and addiction, so they have no benefit and shouldn’t be used.  

This risk is overrated and overstated in relation to opioids prescribed and monitored by a physician. According to the CDC, total opioid overdose deaths in the US (including deaths from illicit opioids) were 24 deaths per 100,000 population in 2023.

That compares to the overdose death rate for prescribed opioids, which was 4 per 100,000 population. That is a raw number for prescribed opioids.  Some data reports opioid deaths among physician monitored chronic pain patients to be as low at 0.1 per 100,000 population. 

In other words, the overdose risk of evidence with prescription opioid is minuscule.

Pain has a number of pathological complications that benefit from opioid therapy. In addition to physical relief, there are humanitarian benefits, such as a reduction in suffering, and the ability to mentally and physically function as a productive person.

When poorly treated or left untreated, chronic pain has profound negative and deleterious effects on the cardiovascular and endocrine (hormonal) systems. Pain puts the cardiovascular system into overdrive, which raises blood pressure and pulse rates. Coronary artery spasm may also result from severe chronic pain.

We can personally attest to prescribing blood pressure medication and nitroglycerin to many pain patients at risk of cardiac arrest or heart failure.

Hormonal suppression and deficiency of cortisol, testosterone, estradiol and other hormones are also common in undertreated chronic pain patients. Cortisol levels can drop below levels that sustain life. We have administered emergency cortisone to pain patients who were severely ill, debilitated, and near collapse because they had inadequate cortisol levels.

Among Dr. Thomas Addison’s eleven reported original cases of Addison’s Disease in 1855, about half had serious intractable pain conditions such as adhesive arachnoiditis.

Chronic pain has also been found to alter blood glucose and lipids (cholesterol). Sleep deprivation is another major problem in pain patients.  And anorexia with malnutrition is common.

Given the medical complications induced by pain, one would logically think that there would always be a discussion of risk-benefit when discussing opioid therapy. But we’ve never heard or seen such a discussion in medical literature or in political circles.

As if denial of benefits over risks weren’t bad enough, an even stranger denial has occurred. We have searched the major medical textbooks used in medical schools today, and couldn’t find a single word that chronic pain is a risk for hypertension and cardiac disease, much less hormonal deficiencies.

Isn’t it time we quit denying that chronic pain has medical complications that can be easily treated with opioids and other medicinals? The risks of opioid therapy simply don’t outweigh the benefits. 

Forest Tennant, MD, DrPH, is retired from clinical practice but continues his research on the treatment of intractable pain and arachnoiditis. Readers interested in learning more about his research should visit the Tennant Foundation’s website, Arachnoiditis Hope. You can subscribe to its research bulletins here.   

Scott Guess, PharmD, operates an independent pharmacy and clinic in Atascadero, CA that specializes in pain management and arachnoiditis.

The Tennant Foundation gives financial support to Pain News Network and sponsors PNN’s Patient Resources section.  

Most Pain Patients Stop Using Medical Cannabis Within a Year

By Crystal Lindell

A small new study found that most pain patients taking medical cannabis stopped using it within one year. 

The research – which was published in PLOS One  – looked at 76 patients diagnosed with chronic musculoskeletal pain, such as back, shoulder and knee pain. The patients were all certified for medical cannabis use at the Rothman Orthopaedic Institute in Pennsylvania between 2022 and 2024

By the first 3-month check-in, 44.7% (34 patients) had already stopped using medical cannabis, which researchers described as “a considerable early drop-off.” 

“This early discontinuation could point to initial expectations not being met, potential side effects, or insufficient symptom relief, which are common reasons for discontinuation in medical treatments,” wrote lead author Sina Ramtin, MD, who was a Research Fellow at the Rothman Institute. 

“Despite the growing acceptance of MC (medical cannabis) as a therapeutic option for chronic musculoskeletal pain, significant gaps remain in understanding its long-term efficacy. While some patients report significant pain relief, others experience dissatisfaction, intolerance, or prefer more definitive treatments, such as surgery or joint injections.” 

By one year, another 10 patients stopped using medical cannabis, which resulted in a total discontinuation rate of 57.9% (44 patients).  

Age was the biggest factor researchers found that separated those who continued using medical cannabis from those who didn’t. The patients who discontinued cannabis tended to be older (mean age of 71.5 years) than those who continued with cannabis therapy (64.5 years).

The researchers think age-related concerns about cognitive side effects, dizziness, or drug interactions may have played a role in decisions to stop using cannabis. Another possible explanation for the high discontinuation rate in elderly patients is that they are more likely to have more advanced pain conditions, such as degenerative disc disease and osteoarthritis, which are more difficult to treat.

The origin of pain, health insurance, and a patient’s race did not seem to have a significant impact on cannabis use, although a higher proportion of patients in the discontinued group reported low back pain. The research team attributed this to “the complexity of managing chronic pain conditions with medical cannabis alone.” 

Interestingly, the researchers did not find much difference in the health outcomes between those who continued using medical cannabis and those who didn’t. They looked at physical and mental health scores for patients, and found that there were no significant differences between the two groups.

“These findings suggest that while MC may offer benefits for some patients, further research is needed to better understand the long-term effects of MC on pain management and patient satisfaction, as well as the factors influencing treatment adherence,” the authors said. 

There has been a strong push over the last decade to reduce the use of prescription opioids, leaving patients little choice but to experiment with “alternative” pain treatments such as medical cannabis. Research like this reinforces the idea that cannabis is not always a perfect option for treating chronic pain.

“The relatively high early discontinuation rate indicates that MC may not provide immediate or sustained relief for all patients and highlights the need for better patient selection and management strategies in the early stages of treatment,” said Ramtin.

Also, while the study doesn’t delve into this, the cost of medical cannabis is often a huge barrier for pain patients. Medical cannabis can be much more expensive than the cash price of generic opioids, and is usually not covered by insurance.

Many of the patients in the study may have found more relief with opioids, but it’s unclear how many were given that option. 

At the end of the day, patients deserve a real choice when it comes to how they treat their pain. That means having access to different medications and therapies. Only then will people truly be able to find what works best for them.  

When Headlines Lie: Misleading News About Opioids and Chronic Pain

By Neen Monty

The headline in Physician’s Weekly screams alarm:

“Rising Use of Potent Opioids in Chronic Pain Management”

And then the sub heading:

“Long-term opioid use for chronic pain doubled, with potent opioids rising, underscoring the need for stronger guideline adoption”

Terrifying, right? We must do something!

But now, read the article. It’s based on a study recently published in the European Journal of Pain on the prevalence of long-term opioid therapy (LTOT) when treating patients with chronic non-cancer pain.

The Dutch study looked at opioid use over a ten-year period, from 2013 to 2022, using a large dataset drawn from primary care records in the Rotterdam region. This database covered more than half a million patients and included data from over 240 general practitioners.

The researchers focused on adults aged 18 and over who had been prescribed opioids continuously for at least three months. They tracked how common LTOT was over time, and also explored which diagnoses, co-existing conditions, and other medications were associated with it. They reported their findings using basic descriptive stats and calculated LTOT prevalence per 100 patient-years to show trends over the decade.

And what did they find?

“The prevalence of LTOT increased twofold from 0.54% (95% CI: 0.51–0.58) per 100 patient years in 2013 to 1.04% (95% CI: 1.00–1.07) in 2022. The proportion of LTOT episodes solely involving potent opioids slightly increased between 2013 and 2022”

In plain English, the prevalence of long-term opioid use by patients at the end of the study was just over 1%.

Yes, that’s right: 1%.

And the prevalence increased by just half a percentage point over a decade.

Hardly a crisis. Hardly anything to scream about.

But we can’t have that! We need a clickbait headline to demonize opioids and stop their prescribing! So, instead of reporting accurately on the very small increase in opioid prescribing, they focus on the “twofold” increase. Trying to manufacture a crisis where there is none.

It’s true, the prevalence of LTOT did double, from half a percent to one percent. And that’s what the headline highlighted, to try and make it sound like there is an opioid crisis in Europe. There is not.

This tactic is often used in presenting medical research – using relative percentages rather than the actual numbers. That is because relative percentages -- “Opioid Use Doubled!” -- sounds worse than “Opioid Use Increased by Half a Percent.”

It’s a trick that researchers and the media use all the time.

Why do this? It’s dishonest. It’s deceptive. And it destroys our trust in science. They are trying to manufacture a crisis when there is none.

Why not research and report an actual crisis? Instead of making one up?

The Physician’s Weekly headline exemplifies the worst of scientific spin: inflating tiny fractional changes and omitting context. It potentially harms patients by reinforcing the myth that opioids don’t work long term and should be withheld. That myth persists because of misleading reporting like this.

Finally! An Honest Headline

It was nice to see some accurate reporting in Scimex, an Australian online news portal that tries to help journalists cover science. Instead of the usual deceptive, sensationalist headlines, this one tells the truth:

“Pain Reprocessing Therapy (PRT) could help those with mild chronic back pain”

This was so refreshing to see! Because it’s so very, very rare.

Most reporting on PRT glosses over a critical point: It has only been studied in people with mild, non-specific back pain. An average of 4 on the zero-to-10 pain scale.

That nuance is often lost in the hype about alternative treatments like PRT, cognitive behavioral therapy, mindfulness and TENS.

You do not treat 8/10 back pain the same way you treat 4/10 back pain.

What happens when people are misled about PRT? It gets recommended to people with severe, pathological pain — often with clearly identifiable causes — and everyone acts surprised when it doesn’t work.

Let’s be clear:

• PRT is not for severe back pain

• PRT is not for pain caused by pathology

• PRT is not a cure-all

But you wouldn’t know that from most headlines about PRT, such as “New therapy aims to cure back pain without drugs, surgery” and “A New Way to Treat Back Pain.”

Then you read the small print: All the participants in PRT studies had non-specific back pain from an unknown cause. And they had mild pain.

The researchers are often complicit, cherry-picking and hyping their own data. Why? Because they need funding. Because they’re writing a book. Because professors have to "publish or perish" to keep their jobs. Because it’s easier to mislead the public than to admit a therapy has limits. And you don’t get to be a guru if your therapy only works for a minority of patients with mild pain.

This kind of spin harms people with severe chronic secondary pain. It feeds the narrative that if you're still in pain, then it’s your fault. You didn’t try hard enough. You’re catastrophizing. You need to retrain your brain.

It feeds the stigma that all chronic pain is mild and easily curable. And that anyone who says their pain is severe has psychological problems.

No. Maybe their pain is caused by pathology, like tissue damage or herniated discs. Maybe their pain is nociceptive or neuropathic.

This is why chronic pain patients must be included on every research team. Someone with real-world, high-impact chronic pain would never let this kind of misrepresentation slide. And the rest of the team wouldn’t be able to claim ignorance.

We need more honesty and integrity in research and the media. We need headlines that reflect the actual findings. We need conclusions that match the data, not some predetermined narrative. Right now, most media coverage doesn’t even try.

Read the study, then read the headline. They rarely match. That’s how we ended up with a generation of healthcare providers who think opioids are bad, all chronic pain is primary pain, and that PRT is some miracle therapy.

It’s not. PRT may be helpful to people who are depressed or have anxiety, but should not be a first-line treatment for everyone. It’s only been tested in people with mild back pain for which there is no known physical cause. It has not been shown to work for people with severe pain or structural pathology.

But the researchers usually gloss over that. And the headlines and conclusions rarely reflect those facts or spell out who PRT is for and who it is not for.

Because here’s the truth: Pain Reprocessing Therapy is not a treatment for chronic pain. It’s a treatment for anxiety and depression.

That’s the real headline.

Neen Monty is a patient advocate in Australia who lives with rheumatoid arthritis and Chronic Inflammatory Demyelinating Polyneuropathy (CIDP), a progressive neurological disease that attacks the nerves.

Neen is dedicated to challenging misinformation and promoting access to safe, effective pain relief. She has created a website for Pain Patient Advocacy Australia to show that prescription opioids can be safe and effective, even when taken long term. You can subscribe to Neen’s free newsletter on Substack, “Arthritic Chick on Chronic Pain.”

‘A Lot of Uncertainty’ if Ketamine Works for Chronic Pain

By Pat Anson

Hundreds of ketamine clinics have opened across the United States in recent years, offering infusions of the anesthetic for a variety of medical conditions – from anxiety and depression to PTSD and chronic pain. Ketamine is only FDA-approved for depression and anesthesia, so its use in treating pain is considered “off-label.”

That off-label use is not supported by scientific evidence, a new Cochrane review has found. Australian researchers analyzed 67 clinical trials involving over 2,300 adults who used ketamine or four similar drugs that block brain receptors and found little evidence that they work as pain relievers.

“We want to be clear – we're not saying ketamine is ineffective, but there’s a lot of uncertainty,” said lead author Michael Ferraro, a doctoral candidate at the University of New South Wales (UNSW). “The data could point to a benefit or no effect at all. Right now, we just don’t know.”

Ferraro and his colleagues looked at the therapeutic effects of ketamine, memantine, dextromethorphan, amantadine and magnesium on various chronic pain conditions and found no evidence that they benefit any condition at any dose. Side effects such as delusion, delirium and paranoia were a major concern, particularly with intravenous use.

"This group of drugs, and ketamine in particular, are in relatively common use for chronic pain around the world. Yet we have no convincing evidence that they are delivering meaningful benefits for people with pain, even in the short term,” said co-author Neil O'Connell, a Professor of Evidence-Based Healthcare at Brunel University of London.

“That seems a good reason to be cautious in the clinic and clearly indicates an urgent need to undertake high quality trials.”

The reviewers also found no studies that support two supposed benefits of ketamine: that it reduces depression and the use of opioids. Ketamine is often used as a treatment for depression or as an alternative to opioids for pain relief.

“We've seen the harm that can come from taking medicines developed for acute pain and applying them to chronic pain, opioids are a prime example. Now we're seeing a similar pattern with ketamine,” said co-author James McAuley, PhD, a Psychology Professor at UNSW and senior researcher at Neuroscience Research Australia.

“As opioid prescribing is slowly reduced, there’s a growing demand for alternatives, but we need to be careful not to rush into widespread use without strong evidence.”

A ‘Lifeline’ for Pain Patients

But patients who have received ketamine infusions found them useful in relieving pain from Complex Regional Pain Syndrome (CRPS) and other difficult-to-treat conditions.

“I implore the medical community not to dismiss ketamine as a treatment option based solely on this one review, when tens of thousands of us are finding relief,” says Barby Ingle, founder and past president of the International Pain Foundation. “For many of us, ketamine is not just an option — it’s a lifeline.

“Chronic pain is a complex, individualized condition, and ruling out therapies that benefit even a subset of patients perpetuates a one-size-fits-all approach that has long plagued healthcare. Such dismissals increase costs to society by limiting access to effective treatments, leaving patients to suffer unnecessarily. I have lost too many friends to suicide with these painful rare diseases.”

In 2009, Ingle had her CRPS, also known as Reflex Sympathetic Dystrophy (RSD) or algoneurodystrphy, treated for the first time with ketamine by the late Dr. Robert Schwartzman, a neurologist who pioneered the use of ketamine infusions as a chronic pain treatment. She went into the hospital in a wheelchair, but was able to walk out a week later after a series of ketamine infusions by Schwartzman. She continues to get infusions regularly.

“My experience with IV-ketamine has allowed me to manage my pain without the fear of addiction or life-threatening side effects, further emphasizing its value as a treatment option long-term,” Ingle told PNN.  

“Ketamine can offer significant advantages over opioids, as it is non-addictive and does not suppress breathing, making it a safer option for long-term pain management. These benefits are particularly crucial for patients with chronic pain, who often face the risks of opioid dependence and respiratory complications. For other patients due to their genetics, lifestyle, and environment, opioids may be the best option. I am saying don’t take any option off the table.”

Ingle says rigorous, high-quality clinical studies are needed to document the benefits of ketamine therapy. Of the 67 studies that were reviewed by researchers, many were small or short-term, which limited their ability to draw conclusions.

Some U.S. medical organizations support the use of ketamine under certain circumstances. The American Society of Anesthesiologists, American Society of Regional Anesthesia and Pain Medicine, and the American Academy of Pain Medicine have guidelines that support ketamine infusions for CRPS, chronic neuropathic pain and short-term acute pain.

FDA Approves First New Fibromyalgia Drug in 15 Years

By Pat Anson

Fibromyalgia sufferers who have yearned for new treatments finally have one. Tonix Pharmaceuticals says the Food and Drug Administration has approved Tonmya for the treatment of fibromyalgia in adults -- the first new FDA-approved therapy for fibromyalgia in over 15 years.

Fibromyalgia is a poorly understand chronic pain condition that affects about 10 million Americans, most of them women. It causes an array of symptoms, such as widespread body aches, fatigue, insomnia, mood disorders and brain fog.

Until now, the FDA has approved only three medications for fibromyalgia: duloxetine (Cymbalta), pregabalin (Lyrica), and milnacipran (Savella). Many patients consider the drugs ineffective or have too many side effects.

“The FDA approval of Tonmya as a first-line treatment for fibromyalgia represents a landmark advancement for the millions of people in the U.S. suffering from the debilitating pain this condition causes,” Seth Lederman, MD, CEO of Tonix, said in a press release. “At Tonix, we recognized the transformative potential of pursuing a new approach with Tonmya for fibromyalgia, a chronic overlapping pain condition, that has gone without innovation for many years.”

Tonmya is more of a sleep aid than an analgesic. The tablet is a new, faster-acting formulation of an old drug: cyclobenzaprine hydrochloride (Flexeril), a muscle relaxant that was originally developed as an antidepressant. Tonmya is meant to be taken before bedtime sublingually, to be dissolved under the tongue for rapid absorption into the bloodstream.

Tonix believes that improving sleep quality, specifically restorative sleep, is the key to reducing fibromyalgia symptoms. Poor sleep not only worsens pain, but causes anxiety and depression, which are common features of fibromyalgia. Pain, insomnia, and mood disorders become a vicious cycle when fibromyalgia is poorly treated.

In a Phase 3 clinical study, fibromyalgia patients taking Tonmya reported better sleep and less fatigue after three months, which coincided with at least a 30% reduction in pain in about half of patients. Tonmya was generally well tolerated, with fewer side effects than the other three fibromyalgia medications.

It’s notable that all of the FDA-approved drugs for fibromyalgia are neither new or novel. They were originally developed for other purposes — to relieve depression or seizures — and are simply being repurposed as fibromyalgia treatments.

“The chronic pain of fibromyalgia is debilitating to every aspect of a person’s life, including causing sleep disturbance and fatigue, all of which can negatively impact someone’s ability to carry out their daily activities,” said Sharon Waldrop, founder of the Fibromyalgia Association. “For over 15 years, this community has been underserved and waiting for new treatment options. This approval is a promising step forward and brings renewed hope to millions.”

Tonmya is expected to become available in the fourth quarter of 2025.