With Little Regulation, Many CBD Products Are Mislabeled

By Pat Anson, PNN Editor

CBD (cannabidiol) is being touted as a treatment for nearly everything these days, from pain and anxiety to insomnia and high blood pressure. There’s even talk about CBD as a potential treatment for COVID-19.

But how much do we really know about the CBD edibles, beverages, oils and other products being sold over-the-counter without a prescription? Are the labels accurate? Are they really free of THC (tetrahydrocannabinol), marijuana’s psychoactive ingredient, as some manufacturers claim?

A new study by researchers at the University of Wisconsin School of Pharmacy should give pause to consumers who put their faith in labels and a cannabis industry that is largely unregulated. The researchers bought 39 CBD products from retail stores in southwest Wisconsin and analyzed them in a laboratory.

Their findings, recently published in the journal Epilepsy & Behavior, found that the vast majority of CBD product labels are inaccurate, containing either too much CBD, too little or none at all. And some products that claimed to be “THC Free” contained enough to give you a good buzz, whether you wanted it or not.

“Our data demonstrate that despite warning letters issued by FDA over the past few years a substantial number of readily available CBD formulations continue to be mislabeled,” researchers reported. “In some cases, products labeled as having CBD contained virtually no active ingredient. This was particularly true for the aqueous (beverage) products.”

Of the 21 CBD-infused beverages that were tested, only one was accurately labeled. The vast majority (78%) were “over-labeled” – meaning they contained less than 90% of the CBD they were supposed to have. The rest (14%) were “under-labeled” – meaning they had 110% or more CBD than the label indicated.

Other products tested, such as edibles, oils and transdermal patches, weren’t much better. Only about a third of the oils (36%) were appropriately labeled with the right amount of CBD, and one oil made by HempLucid contained enough THC to cause intoxication if someone consumed less than half a bottle.

“We found that over half of the studied oil-based products contained measurable THC. This may be of concern not only for the potential of adverse, or at least unexpected, CNS effects, but THC contamination may also create difficulty for patients who are subject to testing for illicit drugs by their employers, parole officers, and even by their own providers in some states as a prerequisite for continued prescribing of controlled substances,” researchers warned.

The concern about THC showing up in drug tests isn’t an idle one. A recent study at Massachusetts General Hospital found THC in nearly 80% of the urine samples from patients who reported using CBD products, including some who thought they were only consuming CBD.

A recent study by Leafreport had findings that were similar to the University of Wisconsin study. Out of 221 CBD products tested, 60% didn’t match their label claims. On average, the CBD content was off from the label by nearly 25 percent.

Although the 2018 Farm Bill legalized the use of hemp-based products that contain less than 0.3% of THC, the FDA has yet to adopt new rules to regulate the cannabis industry. The FDA says it cannot issue regulations until more is known about the safety of CBD products, so for now the agency is “monitoring the marketplace” and only rarely taking enforcement action.

The FDA is well aware of the discrepancies in CBD labeling. A 2021 study by the agency of 147 cannabis products found that less than half contained CBD within 20% of their label declarations. But as long as a company doesn’t make therapeutic claims about their CBD products or call them food supplements, the FDA will probably leave them alone, even if their labels are inaccurate.

Advocacy Group Calls on Insurers to Modify Step Therapy for Migraine Treatment   

By Pat Anson. PNN Editor

The National Headache Foundation (NHF) is calling on health insurers to stop using rigid “step therapy” policies and make it easier for migraine patients to get access to new treatments.

Step therapy is a common practice in the insurance industry to control costs. It requires patients to try cheaper and often older medications first, before “stepping up” to drugs that cost more.   

“For too long, migraine patients have been treated differently than others with medical issues as it relates to access to prescription medications. Specifically, clinicians are often forced to use outdated prescription drugs in a stepwise approach to all patients, without considering the needs of the individual patient,” said Thomas Dabertin, Executive Director/CEO of NHF, a non-profit that seeks to raise awareness about migraine and headache disorders.  

“Unfortunately, the current care models adopted by payers have not kept pace with the many advances in treatment. As a result, clinicians are using older medications, some of which are not even designed for the specific treatment of migraine, even though new migraine-specific therapies now exist.”

Migraine treatment has been revolutionized in recent years by the introduction of neuromodulation devices and drugs that inhibit calcitonin gene-related peptides (CGRP), proteins that cause migraine pain. CGRP inhibitors cost several thousand dollars a year, while neuromodulation devices usually cost several hundred dollars.

Older drugs used to treat or prevent migraine, such as triptans, antidepressants and over-the-counter pain relievers, are much cheaper and often come in generic formulations. Many Insurers require patients to try at least two of the older medications first -- and for months at a time -- before authorizing newer therapies.

“NHF believes it is inappropriate to require all patients to follow this ‘try two and fail’ model before they may be offered treatment with any FDA-approved migraine preventive, including neuromodulation devices, with established lower adverse event profiles,” the NHF said in a position statement.

“For patients who are highly impacted or disabled by migraine, clinicians should not be directed to deliver outdated models of care that apply a predetermined algorithm in a stepwise approach to all patients, without considering the needs of the individual patient, and that encourage the use of older preventive drugs when targeted and migraine-specific therapies now exist.”

The NHF wants insurers to adopt modified forms of step therapy for migraine sufferers, based on the severity of their disease and the frequency of their attacks.

For patients who have seven or fewer migraine days per month, the NHF recommends that patients be required to try only one generic drug for migraine prevention. For patients who experience 8 or more migraine days per month, the foundation recommends that providers have “unfettered access” to FDA-approved prevention drugs.

For the treatment of acute migraine pain, the NHF recommends that two generic drugs be tried first, but if the drugs fail to work within two hours or have unwelcome side effects, providers be allowed to select “another suitable therapy” based on a patient’s needs.  

“The NHF advocates that payers adopt care models that are patient-centric, where the clinician, in collaboration with the patient, is the primary decision-maker and selects a treatment that addresses the patient’s treatment goals and needs,” Dabertin said.

Although the NHF accepts donations from the pharmaceutical industry, Dabertin told PNN the foundation’s new position statement was based solely on input from patients and providers.

Neuromodulation Device Effective for Most Migraine Sufferers

By Pat Anson, PNN Editor

A wearable neuromodulation device significantly reduced headache pain in nearly two-thirds of migraine sufferers, according to a new study. About one in four participants (22.6%) who used the device had no migraine pain after two hours.

The study findings, published in the journal Frontiers in Pain Research, are based on an analysis of over 23,000 remote electrical neuromodulation (REN) treatments with Nerivio, a device worn on the upper arm that uses mild electrical pulses to disrupt pain signals.

It’s important to note the study was designed and funded by Theranica Bio-Electronics, Nerivio’s manufacturer. Three of the five co-authors are Theranica employees.

“The current analysis of a very large group of patients, over a long period of time and multiple treatments, reinforces that REN provides a safe, efficacious and stable treatment option for acute treatment of migraine, both as a standalone and as an adjunct therapy. This is a very important component in the migraine therapy toolbox," lead author Jessica Ailani, MD, Director of the MedStar Georgetown Headache Center and Professor of Clinical Neurology, said in a press release.

Nerivio is controlled by a smartphone app that allows patients to set the intensity of their 45-minute treatments at the onset of a migraine. The app also has a migraine diary that allows patients and their doctors to track the effectiveness of REN.

It is from this app that study data was collected from 12,151 U.S. patients from 2019 to 2021. Most had been prescribed REN by headache specialists, indicating their migraines were difficult to treat with pain medication alone. During the study, about two-thirds of patients only used REN, with the remainder continuing to use over-the-counter or prescription medications.

"To the best of our knowledge, this study is the largest prospective real-world evidence analysis of a migraine device to date," said Alon Ironi, CEO of Theranica.

Migraine affects more than 37 million people in the United States, according to the American Migraine Foundation. In addition to headache pain, migraine can cause nausea, visual disturbances, and sensitivity to light and sound. Women are three times more likely to suffer from migraines than men.

Although migraine sufferers have many new treatments available, such as CBD oil and calcitonin gene-related peptide (CGRP) inhibitors, many find them too expensive or ineffective. Theranica hopes Nerivio can help fill the treatment gap, either as a standalone replacement for medication or as an adjunct.

"While some people with migraine get relief from prescribed or even over-the-counter medications, others do not respond to medications, or cannot tolerate their side effects. There are also people who cannot use medications due to contraindications or being at risk of drug-drug interactions or medication overuse headache,” Ailani said.

The FDA approved Nerivio as a treatment for acute migraine in adults in 2019. Last year the label was expanded to include children over the age of 12 with episodic or chronic migraine. Over 25,000 people in the U.S. have used the device, according to Theranica.

Nerivio is only available by prescription. When purchased wholesale, the listed price is $599 for a twelve-treatment unit, although buyers can save money by enrolling in a patient savings program, depending on their insurance coverage.  

U.S. Ranked Poorly in End-of-Life Care

By Pat Anson, PNN Editor

The U.S. healthcare system barely gets a passing grade in caring for dying patients, ranking well behind most developed countries and even some third world nations, according to a new analysis of end-of-life care around the world.

The United Kingdom earned the highest ranking in the study, followed by Ireland, Taiwan, Australia, South Korea and Costa Rica, which all earned A grades. The U.S. earned a C grade, ranking 43rd of the 81 countries evaluated. Nigeria, Guatemala, Botswana, Romania, Mongolia and several other low-income countries had higher grades than the U.S.  

“Many individuals in both the developed and developing world die very badly – not at their place of choice, without dignity, or compassion, with a limited understanding about their illness, after spending down much of their savings, and often with regret about their course of treatment. These things are very common,” lead author Eric Finkelstein, PhD, a palliative care expert and professor at Duke University’s Global Health Institute, said in a news release.

Top 10 Countries on Quality of Death Index

SOURCE: LIEN FOUNDATION

The study findings, recently published in the Journal of Pain and Symptom Management, are based on a survey of 181 palliative care experts around the world who were asked how well their own countries provided for the physical and emotional wellbeing of dying patients.

Over a dozen health factors were evaluated, including pain management, being treated kindly, affordability, spiritual and emotional needs, and providing patients with a clean and safe space. Treatments that address quality of life, rather than just extending life, were also an important consideration.          

“Perhaps the main conclusion from this important exercise is that most people in the world die badly -- many through no treatment at all and many through excessive often futile treatment that increases suffering,” says Richard Smith, a palliative care expert and former editor of the British Medical Journal.

It’s no surprise that most developed countries with well-funded healthcare systems rated highly in end-of-life care, while poorer countries fared worse.

“The overwhelming need for palliative care is in low and middle-income countries, where less than a third of services exist,” said co-author Stephen Connor, executive director of the Worldwide Hospice Palliative Care Alliance.

The obvious exception to that is the United States’ lackluster rating. Researchers say that’s because healthcare decisions in the U.S. are often based on last-ditch efforts to extend life, rather than ensuring comfort and quality of life in a patient’s final days.  

“We spend so much money trying to get people to live longer, but we don’t spend enough money in helping people die better,” says Finkelstein, who is also the director of the Lien Centre for Palliative Care at Duke-NUS.

The study was funded by the Lien Foundation, a Singapore-based nonprofit focused on improving quality of life. Previous surveys of palliative care experts by the foundation ranked the U.S. 9th on the “Quality of Death” index in 2010 and in 2015.

Finkelstein says the covid pandemic has opened a window into end-of-life care, with millions of patients spending their dying moments alone, often separated from their families and without emotional support.

“Generally, people don’t talk about death. COVID has made it less taboo. We have an opportunity to continue this discussion and not just help COVID patients, but to help everyone have a better end-of-life experience,” he said.

Finkelstein hopes the study will spur action from policymakers to improve conditions for dying patients, such as loosening restrictions on pain medication. A recent study in Oregon found that overzealous enforcement of opioid guidelines led to a significant decrease in opioid prescribing to patients being admitted to hospice, resulting in some terminally ill patients suffering needlessly.

Finkelstein urges people to ensure a better end-of-life experience for themselves and their loved ones by making an end-of-life plan and discussing it with family and friends.

“Do an advanced care plan or at least express your wishes to friends and family,” Finkelstein says. “Don’t wait. By the time you fall ill, it may be too late and folks may not know what you want.”

Saving My Soul From a Real-Life Dopesick

By Cynthia Toussaint, PNN Columnist

While watching Dopesick, the Hulu series that dramatizes Purdue Pharma’s driving of the opioid crisis through their cash-cow OxyContin, I was traumatized to the point of hitting the pause button at least half a dozen times.

The filmmakers were so spot-on with their story telling, I anticipated and said names and organizations out loud before the actors did. You see, I was in the middle of this evil. And I was asked to be a part of the killings for money.

Watching Dopesick reminded me of those god-awful times. Recounting the untold number of people who got addicted to OxyContin and overdosed made me sick. Knowing Purdue and its accomplices nearly got away with it made me sick. How close I was to it all turned my stomach.

In 2003, about a year after I founded For Grace, I was deep in the planning of a California Senate hearing that would shed light on gender care bias toward women with high-impact pain. I loved every crazy-busy moment of this endeavor to give voice to women dismissed by the words, “It’s all in your head.” I was ecstatic to have three female state senators co-sponsoring my hearing that, to this day, remains the most requested event video in Capitol history.     

Out of the blue, Purdue Pharma’s Director of Community Outreach phoned. I’d never heard of Purdue before, but upon overhearing the call, my partner John handed me a note, telling me they were a pharmaceutical company that funded nonprofit pain organizations.

I was flattered that Brenda (not her real name) loved the work I was doing with the hearing, but more than a bit miffed when she recommended her own advocacy people be able to testify. As a start-up nonprofit, For Grace sure as hell needed underwriting, so I agreed to call and get to know her folk. What could it hurt?

I was pleasantly surprised when they were friendly and knowledgeable and, in the end, I chose to go with half my people and half Brenda’s that I and the senators’ staff vetted.

Things went sideways the morning of the hearing when Purdue and those who would testify met with us at the Capitol. After brief intros, Brenda asked for my written testimony and quickly edited it in red pen. I was infuriated by this unwelcomed intrusion.

Still fuming, I arrived late to my own senate hearing as I’d been yelling at John that they had no right to change my testimony just because they’d paid to fly some people in. Who the hell do these creeps think they are?                  

After the successful, standing room only hearing, I was beyond stoked and let the bad energy of the morning pass over dinner with legislators and staffers I adored.

Also in attendance were Purdue and their speakers. That night, at Purdue’s suggestion, we began laying the groundwork for a “Women In Pain” coalition. I was in heaven with the prospects of giving my movement a bigger platform.   

cynthia toussaint (right) testifying at 2004 hearing

Women In Pain (WIP for short) was For Grace’s exciting new project and the cause I wanted most to lead. Springing from a 2001 medical study entitled “The Girl Who Cried Pain” and a follow-up article in The New York Times on the neglect women face in getting their pain treated, I couldn’t wait for the world to learn about WIP. To have a coalition of nonprofit pain leaders and a deep funder behind our movement was a dream.

A dream that would slowly erode into the ugliest kind of nightmare.

When the coalition and Purdue began meeting, the first order of business was to establish an understanding that everyone would be working under For Grace’s umbrella, as we initiated the WIP concept and felt a deep ownership. In fact, we were strongly considering expanding our mission from CRPS awareness to the plight of all women in pain.

Though I’m known for my work ethic, I soon felt overwhelmed by my load. To keep up with For Grace’s everyday activities and the coalition’s needs, John and I were grinding through long hours, seven days a week.

Almost out of the gates, we were getting pushback from coalition members about seemingly everything. Jealousies erupted as I was getting the lion’s share of media attention due to my hustle and drive. Per their demands, I generated media coverage for all members, but that wasn’t enough. Some of them wanted me to script out their answers for interviews. I was beginning to feel beaten.  

‘The Correct Response’

One day I received a call from Purdue inviting me to give the keynote address for pain advocacy conferences they were underwriting in Denver and Philadelphia. The purpose of these events – or so I was told – was to train and inspire pain leaders to effectively interface with media and policy makers.

The person who’d be overlooking this affair was Dr. Richard Sackler, the grand dragon of the family-owned Purdue empire. At the event, Purdue minions were twisted like pretzels in their desire to please this unimpressive man, who struck me as distant and cold.

I was insulted when Purdue insisted that I take a media training class. In a taped, mock interview with their crisis management consultant, I was asked, “What treatment do you advise when a person gets a CRPS diagnosis?”

“Well, there’s a whole range of options out there, including alternative ones,” I answered, spreading my hands a yard wide. “Remember, what works for one person may not work for the next.”

Purdue’s consultant chided me. “As the up-and-coming pain star, you should rethink your answer. The correct response is to take OxyContin,” she said.

Stunned, I responded, “But that would kill people. There’s nothing to rethink.” I felt trapped in a queasy Twilight Zone episode, as not a soul in the crowded room of pain advocacy leaders and healthcare professionals backed me up.

That night, ensconced in our five-star hotel room, it dawned on John and me that everyone in this scheme was training to be a de facto sales force for OxyContin. We were the only schmucks not in on it, though Purdue was actively grooming me to be their #1 patient sales person.           

This bizarre, shady gathering left me with a rancid taste and my enthusiasm curbed for the coalition. But I forged on, at the behest of my advisors, to give Purdue a fair chance to find common ground, a notion I now laugh at.

Next, Purdue offered me an extraordinary opportunity to make WIP fly in an influential, national arena. I was invited to bring our project to “Women In Government”, a powerful organization comprised of female state legislators throughout the country. Thrilled, I introduced my cause at their western regional meeting in Honolulu, then prepared to close the deal at their annual conference in Tucson.

I must admit, I was enjoying Purdue’s lavish courtship – travel, the chauffeur-driven town cars, the choicest suites and the finest meals. After all, I’d earned these perks, I told myself. I was working damn hard and was extremely effective with my message. I knew I was good at what I was doing and it was gratifying to be recognized.

But Purdue continued their insidious attempts to control me. Before my speech, Brenda chided that I’d better knock it out of the park as they were spending a small mint. Further, I was not to go one nanosecond over my 20 minute speaking limit, or else! Hmmm, not the good luck pat on the back I’d hoped for.

Fuming, I made a beeline for the event coordinator, telling her of Brenda’s abuse. Her face turned beet red, angrily telling me that Purdue didn’t run their show. This kind woman reassured me to take a deep breath, then go out and do my thing. So I did.

During my standing ovation, the director came over and hugged me with eyes welling. Joy confided with the room her ongoing bout with chronic pain, along with her ringing endorsement of the WIP movement. Then I was circled by legislators, shaking my hand and thanking me. Most important, they said they’d do whatever I asked.

Later that day, Brenda showed me first-hand what my advocacy future would look like if I played nice with Purdue. During a special session, I watched a Broadway-level singer/actor/cancer survivor entertain the audience, giving them an update about her cause to promote a cervical vaccine. She was living my advocacy dream job – traveling the world, performing, making great money, all the while helping people. That afternoon, she captivated the room.

I had stars in my eyes. For the first time since losing my performance career at 21 due to CRPS, I was being offered a job that would completely feed me. And it was a more noble pursuit than entertaining, as I’d be helping, even saving, many people. But could I get Purdue to come around? They wouldn’t want my services solely to peddle OxyContin, right?

There’s much bigger fish to fry with our shared mission (or so I thought) to put chronic pain and gender care bias on the map. This was my great passion, and I was determined more than ever to thread that needle.

Purdue Wants More

But my naïve hope didn’t float for long. When we restarted our coalition meetings, the women were stone cold toward me, and I felt punished. Their jealousies were amping, and managing all the egos and expectations added to my overload.  I began feeling itchy that the coalition was grinding me to dust in an attempt to heist the project, leaving For Grace behind. The walls were closing in.

I called Brenda and voiced my concern. Oddly, she was warm and reassuring, voicing that, per our agreement, the project would never be taken away from For Grace. To the contrary, she said we were approaching a tipping point where the WIP movement would explode.

I was calm, for about a minute.

On the next call, the gates of hell broke open. The women were backing unethical suggestions from Purdue, including supplying a prominent link from our WIP website to Purdue’s OxyContin marketing page.

John went nuts, sternly stating that was a “slippery slope.” He exploded, “If we give them that link for their money, they’ll want more. And more!"

The women yelled him down, saying For Grace didn’t know how business worked. The back and forth warring finally ended when I pronounced, knowing full well Purdue was on the call, “I won’t be a whore for a pharmaceutical company.” The sounds of phones hanging up followed.

Soon after, I saw in a coalition member’s nonprofit newsletter that she and the others were launching a new organization. It was called “Women With Pain” and parroted our mission. Around that same time, I was abruptly dropped from planned media stories and speaking engagements. Clearly, Purdue’s tentacles ran far and wide. When I threatened to speak to the media about their dirty deeds, Purdue called with a bevy of their attorneys in tow, telling us thuggishly to put a cork in it.

I cried, I yelled, I screamed, I even begged God for mercy. What I’d given birth to had been heisted, and was going to be used to kill people. John and I got deeply ill with what I thought was an epic flu, but looking back, I see it was despair. I became despondent and we were convinced there was no path forward with the good work. Worse, I started thinking deeply about ending my life. I didn’t want to live in a world this soulless.

Saving My Soul

But the fire within hadn’t burned out, and after ample time to grieve, I was able to get out of bed. I was further lifted by For Grace board members who prodded me to not let the bad guys win. Ultimately, I saw that good things could be possible again.

While formally expanding our mission to Women In Pain, I used my persuasiveness to get the pro-bono services of a top-end intellectual property attorney. He sent every coalition member a cease-and-desist letter, advising them not to use the name and idea inspired by For Grace.

I was elated that the letter hit its mark. In fact, the rival organization’s name and announcement were taken down the very next day. Shortly after, I was informed the new coalition was dead on arrival and I knew I’d gotten Purdue, a multi-billion dollar corporation, to buckle.

That’s how I saved my soul from the Sackler family and their savage empire. And I’ve never looked back. Until now.

Those terrible years of trauma surged back while watching the evil dramatized in Dopesick. I was reminded that everything Purdue touched turned to rot. Worse, with few exceptions, everyone enabled them. Without hesitation, they all lapped up Purdue’s dirty money. To make this level of killing possible, Purdue bought support from a wide range of villains: the FDA, policy makers, healthcare professionals and, yes, pain patient advocates. You know who you are.

For years, I’ve watched bad people with bad organizations take bad money to do bad things. And the opioid crisis that Purdue spearheaded has made collateral damage of all of us with pain. Many who need opioids to functionally survive no longer have access.  Many good doctors who responsibly prescribed have been indicted. And for ethical pain organizations who still want to do good work, funding has dried up. I think it’s fair to emphatically state that everyone with pain is suffering in the wake of Purdue’s and their enablers’ sins.               

With apologies, I don’t have my usual up-beat take-away, no words of comfort. Just tears, and a plea. Watch Dopesick, study it, commit this atrocity to memory. Take my word, the pharmaceutical industry is doing just that, and there’s another Purdue in the making that will attempt to make billions off the suffering and murdering of millions. All in the name of pain care. 

I was this close to being one of Purdue’s statistics. But I lived to tell my story. Perhaps it’s not foolish to hope next time more souls will be saved.

Cynthia Toussaint is the founder and spokesperson at For Grace, a non-profit dedicated to bettering the lives of women in pain. She has lived with Complex Regional Pain Syndrome (CRPS) and 19 co-morbidities for nearly four decades, and became a cancer survivor in 2020. Cynthia is the author of “Battle for Grace: A Memoir of Pain, Redemption and Impossible Love.”

Long Covid Linked to Overactive Immune System

By Pat Anson, PNN Editor

People who develop long-haul COVID – even when the initial infection was mild or moderate – have a sustained inflammatory response that appears to be the result of an overactive immune system, according to Australian researchers.

Long covid is a poorly understood disorder characterized by body pain, fatigue, cognitive impairment and difficulty sleeping. About a third of people infected with coronavirus develop symptoms that can last for many months.   

“This study provides the strongest evidence to date for a clear biological basis for the clinically apparent syndrome of long COVID,” Professor Anthony Kelleher, Director of the Kirby Institute at UNSW Sydney, said in a press release.

Kelleher and his colleagues analyzed blood samples from 62 patients enrolled in the ADAPT study at St. Vincent’s Hospital, who were diagnosed with COVID-19 between April and July 2020 – before any vaccines were available. The blood samples were collected at three, four and eight months following initial infection, and compared to control groups.

Their study, recently published in the journal Nature Immunology, identified biomarkers of a sustained inflammatory response in long covid patients – suggesting their immune systems were activated by the virus, but then failed to turn off.

“What we’re seeing with long COVID is that even when the virus has completely left the body, the immune system remains switched on. If you measure the same thing after a standard cough or cold, which we did in this study through one of our control groups, this signal is not there. It’s unique to sufferers of long COVID,” said Professor Gail Matthews, who co-leads ADAPT and is Program Head of Vaccine and Therapeutic Research at the Kirby Institute.

“Simply put, when we look carefully at the immune system in people who have had COVID-19 infection, and particularly at those with long COVID, it looks different to what we would expect in healthy individuals. This tells us that there might be something quite unique in the pathophysiology of this disease.”

The study findings are welcome news to covid long-hauler Rick Walters, who contracted COVID in August 2020 and is part of the ADAPT study. Walters continues to have symptoms 17 months later.

“I’m glad that the study has confirmed that long COVID is a valid result of COVID-19 infection and just not something in my head. At first, I thought I would get better, but it became apparent that the damage to my lung was permanent, and I became quite anxious,” he said. “I have had some difficulties adjusting to my current health. COVID should not be taken lightly. I am gradually learning to live with the results.”

“One of the most surprising aspects of our analysis is that people don’t need to have had severe COVID to experience these ongoing immunological changes,” says Dr. Chansavath Phetsouphanh, a senior research associate at the Kirby Institute. “We found that there is a significant and sustained inflammation that indicates prolonged activation of the immune system response detectable for at least eight months following initial infection.”

Researchers hope that a better understanding of how the immune system reacts to the virus will lead to better treatment and management of long covid. There is no data yet to reflect whether variants like Omicron also cause long covid.

Previous studies of long covid have found similarities with autoimmune conditions such as lupus and myalgic encephalomyelitis, also known as chronic fatigue syndrome (ME/CFS).  

Being fully vaccinated against COVID-19 cuts the risk of developing long covid in half, according to a 2021 study. Researchers at King’s College London looked at data from a mobile app used by millions of people in the UK and found that those who received two doses of the Moderna, Pfizer or AstraZeneca vaccines had significantly lower risk of a “breakthrough” infection that turns into long covid.

FDA Approves Pain Reliever for Cats Considered Too Risky for Humans

By Pat Anson, PNN Editor

The U.S. Food and Drug Administration has approved a new medication to treat osteoarthritis pain in cats, the first monoclonal antibody drug approved by the FDA for use in any animal. The same type of drug has been rejected for use in humans because of safety risks.

Solensia (frunevetmab) is an injectable monoclonal antibody made by Zoetis that targets nerve growth factor (NGF), a protein that increases in animals and humans due to injury, inflammation or pain. Solensia is designed to bind to NGF and inhibit pain signals from reaching the brain.

Osteoarthritis (OA) is a progressive joint disorder that leads to thinning of cartilage and joint damage.  Feline OA is a common condition in older cats, but treatment options for them are limited, as they are for humans.

“Advancements in modern veterinary medicine have been instrumental in extending the lives of many animals, including cats. But with longer lives come chronic diseases, such as osteoarthritis," said Steven Solomon, DVM, director of the FDA's Center for Veterinary Medicine.

"Today's approval marks the first treatment option to help provide relief to cats that are suffering from this condition and may significantly improve their quality of life. We also hope that today's approval of the first monoclonal antibody by the FDA for any animal species will expand research and development of other monoclonal antibody products to treat animal diseases."

Safety Issues with NGF Inhibitors

Last year the FDA refused to approve tanezumab, a monoclonal antibody and NGF inhibitor, as a treatment for OA in humans after two of its advisory panels said the drug caused OA joint damage to accelerate. Rapidly progressing osteoarthritis (RPOA) was so severe that some patients in clinical trials had to stop taking the drug and needed total joint replacements.

The side effects of NGF inhibitors have been known for over a decade. The FDA slowed the development of NGF inhibitors in 2010 because of concerns they make osteoarthritis worse in some patients. But under pressure to approve more non-opioid pain relievers, the FDA allowed clinical studies of tanezumab to resume in 2015.

Eli Lilly and Pfizer invested heavily in tanezumab research, but ended their joint development of the drug in 2021 after the FDA and European Medicines Agency said they would not approve tanezumab for humans because of safety concerns.

In a press release announcing the approval of Solensia for cats, the FDA makes no mention of RPOA in its list of side effects, which includes vomiting, diarrhea, injection site pain, scabbing, dermatitis and itchy skin. The release said side effects were mild and did not require ending treatment during observational animal studies.  

In the FDA’s more detailed Freedom of Information Summary for Solensia, the agency said “RPOA has not been characterized or reported in cats,” but has this stark warning for humans who administer the drug:

“Women who are pregnant, may become pregnant, or are breastfeeding should take extreme caution to avoid accidental self-injection of Solensia. It is well-established that NGF is important in the normal development of the fetal nervous system, and laboratory studies in nonhuman primates have shown that human anti-NGF mAbs can cause reproductive and developmental toxicity. Fetal abnormalities, increased rate of stillbirths, and increased postpartum fetal mortality were noted in rodents and nonhuman primates receiving anti-NGF mAbs.”

Solensia is not recommended for pregnant or lactating cats. It will only be available by prescription from a licensed veterinarian who administers the injection monthly.

“The approval of Solensia is a significant step forward in the control of feline OA pain. Cat owners and veterinarians alike can feel confident that Solensia, with active substance frunevetmab, a monoclonal antibody (mAb) designed specifically for felines, has been studied and demonstrated to control OA pain and help cats get back to moving more freely again,” Mike McFarland, DVM, Chief Medical Officer for Zoetis, said in a statement.

The use of Solensia in cats was approved by the European Medicines Agency last year. The drug is expected to be available to U.S. veterinarians in the second half of 2022.

Hospitals Face Staff Shortages as Covid Surges

By Lauren Weber, Phil Galewitz and Andy Miller, Kaiser Health News

The Cleveland Clinic in Weston, Florida, on Jan. 11 was treating 80 covid-19 patients — a tenfold increase since late December. Nearly half were admitted for other medical reasons.

The surge driven by the extremely infectious omicron variant helped push the South Florida hospital with 206 licensed beds to 250 patients. The rise in cases came as the hospital struggled with severe staff shortages while nurses and other caregivers were out with covid.

The challenge is finding room to safely treat all the covid patients while keeping staffers and the rest of patients safe, said Dr. Scott Ross, chief medical officer.

“It’s not a PPE issue,” he said, referring to personal protective equipment like masks, “nor an oxygen issue, nor a ventilator issue. It’s a volume issue and making sure we have enough beds and caregivers for patients.”

Nationally, covid cases and hospitalizations are at their highest levels since the pandemic began. Yet, unlike previous covid surges, large portions of the patients with covid are coming to the hospital for other reasons. The infections are exacerbating some medical conditions and making it harder to reduce covid’s spread within hospital walls, especially as patients show up at earlier, more infectious stages of the disease.

Although the omicron variant generally produces milder cases, adding the sheer number of these “incidental” hospitalizations to covid-caused hospitalizations could be a tipping point for a health care system that is reeling as the battle against the pandemic continues. Rising rates of covid in the community also translate to rising rates among hospital staffers, causing them to call out sick in record numbers and further stress an overwhelmed system.

Officials and staff at 13 hospital systems around the country said that caring for infected patients who need other medical services is challenging and sometimes requires different protocols.

Dr. Robert Jansen, chief medical officer at Grady Health System in Atlanta, said the infection rate in his community was unprecedented. Grady Memorial Hospital went from 18 covid patients on Dec. 1 to 259 last week.

Roughly 80% to 90% of those patients either have covid as their primary diagnosis or have a health condition — such as sickle cell disease or heart failure — that has been exacerbated by covid, Jansen said.

Although fewer of their patients have developed pneumonia caused by covid than during the major spikes early last year, Grady’s leaders are grappling with high numbers of health care workers out with covid. At one point last week, Jansen said, 100 nurses and as many as 50 other staff members were out.

In one of New Jersey’s largest hospital systems, Atlantic Health System, where about half the covid patients came in for other reasons, not all of those with incidental covid can be shifted into the covid wards, CEO Brian Gragnolati said. They need specialized services for their other conditions, so hospital staffers take special precautions, such as wearing higher-level PPE when treating covid patients in places like a cardiac wing.

At Miami’s Jackson Memorial Hospital, where about half the covid patients are there primarily for other health reasons, all patients admitted for covid — whether they have symptoms or not — are treated in a part of the hospital reserved for covid patients, said Dr. Hany Atallah, chief medical officer.

Regardless of whether patients are admitted for or with covid, the patients still tax the hospital’s ability to operate, said Dr. Alex Garza, incident commander of the St. Louis Metropolitan Pandemic Task Force, a collaboration of the area’s largest health care systems. He estimated that 80% to 90% of patients in the region’s hospitals are there because of covid.

In Weston, Florida, the Cleveland Clinic is also having a hard time discharging covid patients to nursing homes or rehabilitation facilities because many places aren’t able to handle more covid patients, Ross said. The hospital is also having difficulty sending patients home, out of concern they would put those they live with at risk.

Hospital Infections

All this means there’s a reason that hospitals are telling people to stay away from the ER unless it’s truly an emergency, said Dr. Jeremy Faust, an emergency medicine physician at Brigham and Women’s Hospital in Boston.

The sheer number of patients who are showing up and don’t know they have covid during this surge is frightening, Faust said. As more incidental cases pour into hospitals, they pose a greater risk to staffers and other hospital patients because they are typically at a more contagious stage of the disease — before symptoms begin, Faust said. In previous covid waves, people were being hospitalized in the middle and later phases of the illness.

In Faust’s analysis of federal data, Jan. 7 showed the second-highest number of “hospital onset” covid cases since the pandemic began, behind only an October 2020 outlier, he said. But this data accounts for only people who were in the hospital for 14 days before testing positive for covid, Faust said, so it’s likely an undercount.

A KHN investigative series revealed multiple gaps in government oversight in holding hospitals accountable for high rates of covid patients who didn’t have the diagnosis when they were admitted, including that federal reporting systems don’t publicly note covid caught in individual hospitals.

“People in the hospital are vulnerable for many reasons,” said Dr. Manoj Jain, an infectious disease specialist in Memphis, Tennessee. “All of their existing underlying illnesses with multiple medical conditions — all of that puts them at much greater risk.”

The ER in particular is a potential danger zone amid the current crush of cases, Garza said. He recommended that patients wear high-quality masks, like a KN95, or an N95 respirator. According to The Washington Post, the Centers for Disease Control and Prevention is weighing whether to recommend that all Americans upgrade their masks during the omicron surge.

“It’s physics and math,” Garza said. “If you’ve got a lot of people concentrated in one area and a high viral load, the probability of you being exposed to something like that if you’re not wearing adequate protection are much higher.”

If patients can’t tolerate an N95 for an entire day, Faust urges them to wear upgraded masks whenever they come into contact with hospital staffers, visitors or other patients.

Dr. Dallas Holladay, an emergency medicine physician for Oregon’s Samaritan Health Services system, said that because of nursing shortages, more patients are being grouped together in hospital rooms. This raises their infection risk.

Dr. Abraar Karan, an infectious diseases fellow at Stanford, believes all health care workers should be mandated to wear N95s for every patient interaction, not just surgical masks, considering the rise in covid-exposure risk.

But in the absence of higher-quality mask mandates for staffers, he recommended that patients ask that their providers wear an N95.

“Why should we be putting the onus on patients to protect themselves from health care workers when health care workers are not even going to be doing that?” he asked. “It’s so backwards.”

Some hospital workers may not know they are getting sick — and infectious. And even if they do know, in some states, including Rhode Island and California, health care workers who are asymptomatic can be called back to work because of staffing shortages.

Faust would like to see an upgrade of testing capacity for health care workers and other staff members.

At Stanford, regular testing is encouraged, Karan said, and tests are readily available for staffers. But that’s an exception to the rule: Jain said some hospitals have resisted routine staff testing — both for the lab resource drain and the possible results.

“Hospitals don’t want to know,” he said. “We just don’t have the staff.”

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

Constant Pain Can Lead to Diabetes, High Cholesterol and Heart Problems

By Dr. Forest Tennant, PNN Columnist

Intractable Pain Syndrome (IPS) is constant pain with cardiovascular, metabolic and hormonal complications. Constant pain is a severe stressor that causes the adrenal hormones cortisol and adrenalin to rise in the blood as the body attempts to reduce stress.

These hormonal elevations can lead to serious metabolic consequences that need to be well known to persons who have IPS, as well as their family and medical practitioners. High levels of adrenalin cause blood pressure and the pulse rate to rise. When cortisol is elevated, it causes the hormone insulin and blood sugar (glucose) to rise in the blood.

If blood sugar remains too high for too long, a person can develop diabetes or pre-diabetes, which is often called “insulin resistance.” Most persons believe that diabetes is a metabolic disease and is unrelated to hormones. The fact is that insulin, cortisol and adrenaline are hormones.

In addition to diabetes, a person with constant pain is also at high risk of developing or experiencing any or all of the following: 

  • Heart Attack

  • Heart Pain (Angina)

  • Stroke

  • Dementia

  • Arteriosclerosis

Some persons with IPS have died suddenly and unexpectedly, sometimes while asleep. Often these cases are falsely labelled as a drug overdose.

There are three reasons for sudden, unexpected death in persons with IPS who are undertreated and have cardiovascular, metabolic and hormonal complications.

  • Cardiac Arrythmia

  • Adrenal Failure          

  • Hypoglycemia (Excess Insulin)

Every person with IPS needs to be evaluated for diabetes, pre-diabetes, hypertension, tachycardia and excess cholesterol. Steps must be taken to eliminate or reduce any or all of these IPS complications. Consult your medical practitioner at your earliest opportunity for an evaluation of these complications. 

Forest Tennant, MD, DrPH, is retired from clinical practice but continues his research on intractable pain and arachnoiditis. This column is adapted from newsletters recently issued by the IPS Research and Education Project of the Tennant Foundation. Readers interested in subscribing to the newsletter can sign up by clicking here. The Tennant Foundation gives financial support to Pain News Network and sponsors PNN’s Patient Resources section.     

Study Finds Opioids Not Always Needed After Heart Surgery

By Pat Anson, PNN Editor

It’s become common in recent years for U.S. hospitals to reduce or even eliminate the use of opioids for post-operative pain. For the most part, these non-opioid policies only apply to “minimally invasive” arthroscopic or laparoscopic surgeries, in which small incisions are made and patients are often sent home from the hospital the same day.

A new study by researchers at the University of Michigan suggests that many patients who have more complicated and invasive heart surgeries may also be able to control post-operative pain without opioids after they are discharged.

“In some cases, patients assume that after surgery, especially a big operation like cardiac surgery, that they will need to go home with prescription pain medicine,” said Catherine Wagner, MD, a cardiothoracic surgery resident at University of Michigan Medicine. “This study shows that discharge without opioid pain medicine after cardiac surgery is extremely well tolerated by some patients. In other words, we should not be reflexively prescribing pain medicine to people after surgery just in case they need it.”

Wagner and her colleagues looked at for over 1,900 patients who had coronary bypass and/or heart valve repair surgery at Michigan hospitals in 2019. Both procedures require a sternotomy, in which a doctor uses a saw to cut through the breastbone (sternum), which is then spread apart to gain access to the heart. When the surgery is finished, doctors reconnect the sternum with stainless steel wires. Full recovery from a sternotomy will usually take months.  

The study findings, published online in The Annals of Thoracic Surgery, showed that more than one-fourth of the surgery patients (28%) did not receive an opioid prescription at the time of discharge and used non-opioid pain relievers instead. Researchers say not getting an opioid appears to have been “well tolerated” by these patients, because less than 2% needed an opioid prescription before their 30-day follow-up appointment.

The study did not look at patient outcomes, whether patients were satisfied with their pain management, or if patients who did receive opioids developed signs of addiction or dependence. But researchers concluded that opioids were often not necessary after heart surgery.

“These data suggest that not all patients require an opioid prescription after cardiac surgery and that discharge without an opioid prescription is well tolerated in select patients. Cardiac surgery providers should consider shifting focus from the amount of opioid to prescribe to patients to instead determine which patients do not need any opioid prescription at discharge,” researchers concluded.

Before concerns rose about opioid addiction and overdose, it was common for surgery patients to be discharged with 50 to 100 opioid pills. Many of those pills would go unused.

“One should consider if these opioid prescriptions were truly necessary for patient pain relief,” said Wagner. “Our study shows that, particularly for patients who did not take any opioids on the day before leaving the hospital, discharge without opioids is safe. I think we need to ensure that only patients who truly need opioids get sent home with a prescription.”

Patients rarely become addicted to opioids after surgery. A large 2016 study found that less than one percent of older adults were still taking opioid medication a year after major elective surgery.  Another large study in 2018 found only 0.6% of surgery patients prescribed opioids were later diagnosed with opioid dependence, abuse or a non-fatal overdose.

A recent survey found nearly 8 out of 10 U.S. adults believe opioids are sometimes necessary to manage post-operative pain. Most people are more worried about treating surgical pain than they are about becoming addicted to opioids.

What’s Missing in ‘Opioids: The Big Picture’

By Roger Chriss, PNN Columnist

Canadian family physicians Mark Dubé and Henry Chapeskie recently created a video called “Opioids: The Big Picture” to give what they describe as a “short history of how we got into trouble with opioids, how even a small number of opioid pills can lead to addiction, and why they should not be used in non-cancer chronic pain.”

Drs. Dubé and Chapeskie spend the first third of their hour-long video on the history of opioids, mostly the 19th century Opium War in China, and the remaining time on modern prescription opioids. They refer to opioids as a “global environmental toxin” which cause “narcotic neurotoxicity.”

They also claim that opioid-induced hyperalgesia is common, that no studies show any benefit to opioids for pain management, and that opioids cause permanent brain damage. They argue that the current opioid crisis is driven by the steadily increasing supply of prescription opioids and should be addressed the way we handle air pollution. They conclude by saying that “opioids are neurotoxic, cause pain, and are toxic to the individual and society.”

None of this holds up well to close scrutiny. The Opium War was about more than a “state-sponsored monopoly with an illicit drug.” In fact, there were two Opium Wars, with the first being about trading rights, open trade and especially diplomatic status, and the second war directed at expanding trade, including opium, between Europe and China.

The notion that opioids are a “global environmental toxin” comparable to air pollution assumes exposure is passive and inevitable. But opioids are not like mercury or asbestos, emitted as a contaminant from industrial processes that could be cleaned up. Their claims about neurotoxicity are also problematic. Although small-scale imaging studies do show changes to some brain structures upon opioid exposure, the significance of this is unclear.

Their emphasis on opioid-induced hyperalgesia (OIH) – the theory that prolonged use of opioids leads to greater pain sensitivity -- is also greatly overstated. A 2021 review of published studies found only 72 patient cases of OIH, all of which were easily diagnosed and managed by opioid rotation, opioid cessation or switching to non-opioid pain medications.

Last and most important, Dubé and Chapeskie claim that “there is no evidence (zero!) to support use of opioids” for chronic non-cancer pain. They cite the 2018 SPACE trial as their major source of evidence, although that study showed opioids were no better or worse than non-opioids for pain relief. More importantly, the SPACE study didn’t find any evidence of abuse, misuse, addiction or overdose among the 108 people on opioids for a whole year, which argues against the very risks that Dubé and Chapeskie describe as inevitable.

Dubé and Chapeskie point to a single study on opioid tapering that showed good outcomes. That 2020 study found only minor improvement in cognitive function after opioid tapering. Multiple other studies show the risks and harms of tapering often outweigh its benefits, especially when tapering is rapid.

Moreover, there are clinical studies showing that opioids are effective and safe when used appropriately. A 2021 German study, for example, found that tapentadol relieves chronic low back pain, and a 2017 review found tapentadol was effective and well-tolerated by patients with moderate to severe pain for up to two years.

The video “Opioids: The Big Picture” could have been a useful introduction to opioid pharmacology, chronic non-cancer pain, and clinical practice. It could have introduced current best practices for opioid initiation and tapering. And if the focus was to be on the public health risks and harms of opioids, then it should have followed the fine work of David Courtwright's book "Dark Paradise”, Sam Quinones's "Dreamland”, or Chris MacGreal's "American Overdose".

It is unfortunate that even in the 2020s we are still struggling to get basic information about opioids right. This is arguably part of why we have a worsening opioid crisis and deteriorating pain management situation.

Roger Chriss lives with Ehlers Danlos syndrome and is a proud member of the Ehlers-Danlos Society. Roger is a technical consultant in Washington state, where he specializes in mathematics and research.  

Kratom Candy: A Sweet Alternative to Powder

By Crystal Lindell, PNN Columnist

I first started taking kratom for my chronic pain almost four years ago. I have debilitating pain in my right ribs that has been diagnosed as intercostal neuralgia. Until I found kratom, nothing sold over the counter had ever helped at all — not even the magic mix of Tylenol and Advil that doctors have been touting of late.

The only issue with kratom is that the leaves, when ground up into powder, taste like dry dirt. But when you’re in pain, and you find something that works, you tend to overlook things like horrible taste. I got used to it by the “toss and wash” method -- putting a spoonful of kratom powder under my tongue and then washing it down with a non-carbonated beverage, usually Gatorade.

But it’s not ideal, and the bad taste makes it difficult to recommend kratom to people who could benefit from it —  especially as doctors continue to limit access to prescription pain medication.

So when I recently got the chance to try some kratom candy and other new formulations, I was excited. Kratom taffy, kratom chocolate, kratom soft gels and even a kratom seltzer? Are these the kratom edibles I've been waiting for?

In short: Sort of. 

Below I offer a review of each one, ranking them on a 5-star scale and offering pros and cons for each product.

But first, a bit of context. I went into this comparing all of the items to my personal kratom go-to: loose kratom powder. The powder tends to work for my pain within about 3 minutes and it’s relatively cheap. I usually get it in bulk from my local smoke shop for about $150 a kilo, which comes out to about 70 cents for a 5 mg. dose. I usually take a dose every 3-5 hours while I’m awake, depending on how much pain I’m in.

Readers should also know that this review is not sponsored by any kratom vendors or brands, although the companies did send me these items to try for free.  We reached out to several kratom vendors and asked them to send us samples, and CBD Kratom and PurKratom obliged.

Let’s look at the various new kratom products.

Raw Kratom Taffy ★★★★★ 5/5 stars

Let’s start with what ended up being my favorite new product: Raw Kratom Taffy.

CBD Kratom sells it in multiple strains, so consumers can purchase a piece of taffy in red maeng da, white maeng da, green maeng da, and gold maeng da.

According to the ingredient list, a 20 mg. piece is one serving. However, I only ate about a 1/3 of a piece and it was enough to tackle my pain on an especially bad evening. Since each piece costs about $6, it’s good to know that it could be used as more than one dose.

Pros: It worked really well, hitting me in less than 30 minutes. And I did like the flavor, which the ingredient list said was created with fruit juices. It doesn’t taste like candy, but it doesn’t taste particularly bad and that’s a massive accomplishment for any kratom edible.

I also really liked that it came in various strains, because I have a strong preference for red maeng da, while simultaneously hating white maeng. They all work differently for people, so being able to know which one I was consuming definitely elevated the experience.

Cons: The taffy itself was incredibly difficult to bite into and I felt like I was going to break my teeth trying to chew it. I’m hopeful that the company will be able to tweak the formula a bit to work on this. It’s also a little pricey compared to the powder. I don’t think I’d want to switch to something like this for all my kratom needs, but for occasional use it was great.

PurKratom Soft Gels ★★★★☆ 4/5 stars

These would have been my favorite item if they weren't so expensive. PurKratom has them listed at $79.99 for just 20 capsules.

Nearly $80 is just a tad more than I would be willing to pay on a regular basis. Especially since the soft gel capsules can't be split like a pill into multiple doses. And it would be difficult to recommend these to someone knowing they would have to spend $80 for their first order.

The capsules did work though, and they were much easier to get down than either kratom powder or the kratom edibles I tried. The company says they are made with “high concentrations of organic kratom extracts,” with each soft gel containing 33 mg of pure extract.

I would love to see these sold by strain like the taffy is, but the formula they did use worked for me. 

Pros: These are by far the easiest item to get down. It’s like popping some Advil liquid gels. I took one at a time, and it hit me within about 30 minutes, alleviating my pain without making me fuzzy or giving me a head rush. For anyone who could benefit from kratom, but who hasn’t tried it yet because they can’t stand the delivery method, these are a wonderful option.

Cons: The price is the biggest issue with the capsules for me. Although the soft gel formulation makes them significantly better than the kratom capsules already on the market — which are usually just kratom powder stuffed into capsules — at $4 for each capsule, that’s just too much to spend on a product that I can get significantly cheaper in powder form. 

Korthal’s Collection No 539 Kratom Seltzer ★★★☆☆ 3/5 stars

This item was especially intriguing to me, as it’s the first time I’ve ever come across a kratom drink.

Korthal's Collection has it listed at $35 plus shipping for a 4-pack of 16-oz. cans, which is a little high for my budget. The company says the seltzer is made with “75mg of full spectrum mitragynine per 16oz can” and is best used for “increased focus, mood elevation and energy boosts.”

Pros: It doesn’t taste that bad. It’s not refreshing exactly, but it’s not any worse than a bitter alcoholic beverage. It tastes kind of like a strong tea and definitely needs to be consumed chilled. I’d love to see them add a lemon honey flavor to the line-up.

Overall, a full can was very potent. I only drank about a 1/3 of a can and it hit me within about 20 minutes. My fiancé drank a whole can and really felt the effects, both on his physical pain and mood.

Cons: While the flavor wasn’t bad, it wasn’t exactly good either. There was a strong aftertaste and I felt the need to eat something else to get rid of it. While the cans tout the seltzer’s ability to lift your mood and give you energy, that wasn’t my experience. If anything, it was more relaxing and subduing.

Also, the price point is a little high. It’s just expensive enough that I’m not sure I would order it on a regular basis. However, if my local smoke shop sold individual cans, I could see myself grabbing one as a treat when I went in to purchase the powder.

Korthal’s Collection: No 395 Milk and Dark Chocolate ★★★☆☆ 3/5 stars

This is probably the item I was most excited to try. Kratom? Good. Chocolate? Good. Kratom Chocolate? It was okay.  

Korthal's says “these velvety chocolate bars are best for energy and may provide pain relief and mood enhancement.” The company has them listed at $20 for a single 1.3-oz bar and they come in both milk and dark chocolate. Each bar has 8 serving squares. The packaging says they have 25 mg. of mitragynine per serving.

Pros: This is something I could easily get my older relatives to try for their arthritis. The bars don’t taste anything like a regular chocolate bar, but they also don’t taste anything like plain kratom powder. They’re chocolaty enough to easily eat a square, even if you aren’t used to the taste of kratom.

However, I did find myself using a chaser afterward to get rid of the aftertaste. And while each bar is expensive, I would feel comfortable recommending these to someone who could try it out for just $20.

As far as potency and effect, one square was definitely enough, although like the taffy, it took about 30 minutes to feel the effect. For me, it gave me a bit of a disconnected head buzz while also relieving my physical pain.

Cons: Again, the price is a little high. While it’s about in line with a lot of CBD candy on the market, it feels expensive compared to kratom powder. Adding child-proof elements to these and other kratom candies would be a good idea.

I also wish the chocolate was sold by strain, like the taffy, because I’d like to have more control over which types of kratom I’m consuming and when.

Takeaways

In the end, I find myself still reaching for my trusty kratom powder from the local smoke shop, even though I still have some of the chocolate and taffy left over. The powder just works faster and it’s also significantly cheaper per dose. The fact that taking kratom under my tongue hits me in less than 3 minutes is just such a major advantage that none of these other products could compete with. That’s not the fault of the manufacturers, it’s just the nature of the products.

For someone who doesn’t need that instant pain relief though, a lot of these edibles work in about the same amount of time as any other pain medication, and I’m sure a lot of consumers would be fine with that.

If the gel capsules came down in price, I would likely buy those for myself on a regular basis. And even at their current price, I’ll probably buy some for my relatives who I think could benefit from kratom, but who just haven’t been able to get the powder down. My fiancé, who is also a chronic pain patient, really enjoyed the seltzer.

The bottom line is that all these products could be great alternatives for anyone who just doesn’t vibe with swallowing a spoonful of soil-flavored kratom powder.

It’s exciting to see how far the kratom industry has come since I first started using it almost 4 years ago. I have long hoped companies would venture into kratom edibles and better capsule products. Finally seeing those products develop is wonderful, and I can’t wait to see what comes next!

Crystal Lindell is a journalist who lives in Illinois.  After five years of unexplained rib pain, Crystal was finally diagnosed with hypermobile Ehlers-Danlos syndrome.

 

Why Patient Advocacy for Rare Diseases Is Important

By Joanna Mechlinski, Guest Columnist

If you’ve been relatively healthy throughout your life, you tend to have a lot of faith in doctors. You believe that when a person gets sick, they simply go see a doctor and soon everything is better.

Movies and television only serve to bolster that impression, as characters frequently show up in hospitals with a baffling array of symptoms, only to have a doctor dedicated to the case quickly diagnose them.

Even if it’s a rare disease or condition which the doctor has never seen outside of a textbook, they will piece it all together successfully -- often continuing to puzzle it out after their work day has ended. The patient then receives medication or therapy from specialists. It’s understood that while recovery might take a while, it’s generally always possible.

Unfortunately, in real life, things often don’t work out this way. You might explain your symptoms to the doctor, who orders blood tests and other diagnostics. When the results come back, they’ll shrug and tell you they simply don’t know what’s the matter. As your symptoms increase, so does your desperation for relief, so you try other doctors and medical facilities, often with the same outcome.

In the U.S. we use the term “rare” to describe a disease that affects fewer than 200,000 individuals (in the EU it’s fewer than 1 in 2,000 people). But the reality is many of these diseases aren’t all that rare. They simply aren’t as common as things like breast cancer or diabetes. The National Institutes of Health’s Genetic and Rare Diseases Information Center says there are approximately 7,000 rare diseases.

In 2005, I was diagnosed with polymyositis, a rare disease that causes muscle inflammation and atrophy. I had never heard of it, nor had any of my family or friends. Go ahead and Google it -- you will quickly see just how little information exists, aside from basic definitions and the occasional patient GoFundMe. Yet per The Myositis Association, there are an estimated 50,000-75,000 people affected by a form of the polymyositis in the U.S.

Following my diagnosis, I made appointments with many specialists, some in world-renowned facilities. They seemed to know little more than I did, and I often found myself explaining various elements of the disease to them.

It would have been easy to simply give up. If much of the world didn’t even know my disease existed, then how could I hope for understanding from family and friends, much less treatment or a cure?

I learned a few lessons quickly about being a patient advocate, which I still follow today:

  1. Tell your story: Yes, sometimes it’s hard to reveal personal details. But in this instance, I believe I need to use my life to educate others. What if someone else has a form of myositis, but is still undiagnosed? Both doctors and patients need to keep the condition in mind when viewing certain symptoms. I have written many freelance articles about polymyositis for various publications, and I am now writing a book.

     

  2. Contact lawmakers: Yes, people often grumble politicians don’t do anything for them. But how can they even consider getting help for a problem they don’t know exists? Reach out to lawmakers at the local, state and federal level. Tell them about your disease and how it affects your life. Tell them what you and others with the condition need.

     

  3. Connect with others: Thanks to the Internet, it is now easy to find people sharing an illness, regardless of how rare it is. It’s also easier to keep in touch when in-person visits may be difficult due to pain, fatigue, travel costs, etc. Making friends with people who have similar conditions can be very beneficial, particularly when sharing information about medications and treatments. It can also be a godsend to simply vent and gain support from a person who truly understands what you’re going through.

Under the guidance of the National Organization for Rare Disorders (NORD), the first Rare Disease Advisory Council (RDAC) was created in North Carolina in 2015. The goal was to strengthen the rare disease community’s voice in the state legislature.  

Patients and their families, caregivers and medical providers then banded together in other states. By the end of 2021, NORD reports that legislation creating more RDACs had been signed into law in Florida, Louisiana, Massachusetts, New Jersey, Ohio, South Carolina and Virginia. In all, Project RDAC contacted 254 legislators and introduce 11 RDAC bills.  

Being diagnosed with a rare disease while in my 20’s was not exactly among my childhood dreams for the future, but I’m far from resigned. I recall how diabetes - today usually considered a fairly manageable condition - was a death sentence until well into the 20th century, when insulin was discovered.  

Who’s to say that polymyositis and other rare diseases might not veer onto a similar path at any time? Until then, I will do my best to advocate and educate. 

Joanna Mechlinski is a former journalist who currently works in school transportation. She lives with lupus, polymyositis and fibromyalgia, and is passionate about advocacy. 

Pain News Network invites other readers to share their stories with us. 

Send them to:  editor@PainNewsNetwork.org

How to Overcome Suicidal Thoughts and Find Hope

By Ann Marie Gaudon, PNN Columnist

Over the course of our lives, every single one of us will have painful thoughts and emotions in response to adversities and challenges. A sense of hope that we will either cope with or overcome the adversity helps to keep us going.

But when all hope is gone, this can lead to the desire to leave life itself. Hopelessness and helplessness are key factors in the decision to escape a life that is seen as unbearable.

Globally, we lose over 700,000 people to suicide every year. That tells us millions of people are suffering, both mentally and physically, struggling and searching for relief which too often does not come.

Suicide causes heartache and grief for those left behind, affecting families and entire communities. If that weren’t enough, knowing someone who died by suicide is linked to an increased risk for suicide and other mental health challenges.

Suicidologists have developed various theories in an attempt to identify common factors across suicidal experiences. Here are three:

Interpersonal Theory of Suicide

The person no longer feels they belong in a healthy sense, but rather feels like a burden to others. They see their situation as never changing, and therefore hopeless.

Three-Step Theory of Suicide

Step 1: The combination of pain and hopelessness causes suicidal desire.

Step 2: Suicidal desire intensifies when pain exceeds or overwhelms connectedness.

Step 3: Strong suicidal desire progresses to suicide attempts if a capability for suicide is present.

Although this theory differs in certain ways, it similarly advises that psychological or physical pain must be accompanied by hopelessness to cause suicidal desire.

The Integrated Motivational-Volitional Model

This model’s hypothesis is that “entrapment” or feeling there is no escape from the adversity drives the suicidal behaviour. Entrapment refers to a specific sense of being stuck, whereas hopelessness refers to a sense of pessimism. Hope appears to “weaken the relationship between entrapment and suicidal desire.”

The aim of these researchers is to identify the factors which shift suicidal thoughts into suicidal behaviour, in order to reduce or eradicate these factors and save lives. They all posit that hope is necessary even in the face of intolerable pain, whether physical or emotional.

One thing I have learned as a therapist is that people have a choice only if they believe they have a choice. Hope must ring true to a person’s reality.

Seek Social Support

Research shows us that social isolation is associated with increased risk of suicide, while social support is related to a decreased risk. Who in your life’s circle has the headspace to support you, listen to you, and help you when needed? Your spouse, family, friends, neighbours, colleagues, and clergy – can you count on their support?

Sometimes, a person’s only support is their therapist.  Support is a protective factor and necessary as an antidote to social isolation.

Attend to Your Emotions

Trying to avoid or distract yourself from your emotions will only have them rebound back to you and be even more invasive. As emotional pain is one driver of suicidal thoughts, get some help to process what you are feeling.

Can you notice and name what you are feeling? Can you accept what you are feeling without being overwhelmed by it? Do you recognize the message within the emotion? Are you aware of, and capable of self-compassion directed toward your pain?

Quite often I see the need for self-compassion and the need for support from others simultaneously. Once you can let your emotions be just as they are, are you able to shift yourself into soothing your psychological pain? Are you capable of moving into a more valued direction? 

If you have answered “no” to any or all of these questions, a trained therapist can help you.

Broaden Your Perspective

The hopelessness theory of depression tells us that most people who feel hopeless believe their struggles are unique to them (internal) or about them (global struggles), and that these struggles are unchangeable.

Therapeutic work can help to unravel why a person might believe that they themselves are hopeless. Talk and other techniques can reveal where these beliefs began and why. When the origins of erroneous, negative beliefs are understood, they can be replaced with beliefs that are based in reality and not a product of emotional reasoning (e.g. “I feel like I have no worth, therefore it must be true”).

Global struggles can often be tamed with the support of a group. Support groups offer a multitude of protective factors such as encouragement, friendship and guidance. You can be with people who can truly empathize with you and comfort you as an antidote to your own disappointment, frustration and confusion. Peer support can be powerfully protective and also help to dissipate any stigma you may be feeling toward yourself or situation.

Gain a Purpose

The antidote to feeling powerless is to feel empowered. Again, peer support from a support group can contribute to a sense of empowerment and purpose. Reduced isolation, empathy from others, and an increase of information and awareness are all threads in the fabric of assertion, better life choices, and a sense of hope that the situation can be changed. If it can’t, then your perspective about the situation can be improved.

Support groups are effective because they bring together people who all share something in common. This creates a support system. With most gatherings now online, you can find a support group for virtually any issue.

For example, I am a person in pain, so I can find these similarities, support and empowerment from an organization in my country: The Chronic Pain Association of Canada. I also belong to a smaller support group with a very specific ailment in common. One of my diagnoses is interstitial cystitis/painful bladder syndrome, so I also belong to The Happy Pelvis for the same benefits.

The Takeaway Message

No one can make it alone. Life is a collaboration and we often need help and support. There is no shame in this, it is the human condition. Suffering is what unites us -- it does not separate us from the crowd.

Whatever your challenge, you are not alone. Get the help you deserve and surround yourself with supportive allies. When you are feeling more empowered and stronger in general, you can be a part of change. That change may be within yourself or it may be a part of the outside world. Where there is help, there is hope.

Ann Marie Gaudon is a registered social worker and psychotherapist in the Waterloo region of Ontario, Canada with a specialty in chronic pain management.  She has been a chronic pain patient for over 30 years and works part-time as her health allows. For more information about Ann Marie's counseling services, visit her website. 

If you are in crisis and live in Canada, help is available by calling the Canada Suicide Prevention Service at 833-456-4566. If you live in the US, help is available by calling the National Suicide Prevention Lifeline at 1-800-273-8255 (TALK). You can also call 911 for immediate help..

Gabapentinoids and Anti-Depressants Recommended for Diabetic Neuropathy

By Pat Anson, PNN Editor

People with painful diabetic neuropathy (PDN) should be treated with gabapentinoids, anti-depressants and sodium channel blockers, according to updated guidelines from the American Academy of Neurology (AAN). The guidelines also recommend some alternative treatments, such as ginkgo biloba, capsaicin patches and cognitive behavioral therapy, but strongly discourage the use of opioids.

The AAN’s new guidelines, published online in the journal Neurology, acknowledge that many of the recommended therapies for PDN don’t directly treat physical pain, but they improve mood and sleep, and that helps reduce “pain perception.”

“In treating patients with PDN, it is important to assess other factors that may also affect pain perception and quality of life. Patients with diabetes are more likely to have mood disorders (most commonly, major depression) and sleep disorders (especially obstructive sleep apnea) than the general population,” an AAN panel of experts found. “Therefore, treating concurrent mood and sleep disorders may help reduce pain and improve quality of life, apart from any direct treatment of the painful neuropathy.”

Nearly 26 million Americans have diabetes and about half have some form of neuropathy, according to the American Diabetes Association. PDN causes nerves to send out abnormal signals, causing patients to feel stinging or burning pain, as well as loss of feeling in their toes, feet, legs, hands and arms. More severe cases can result in ulcers or amputation of the affected limbs.

The last update to the AAN guideline was in 2011, when opioids such as morphine and oxycodone were said to be “probably effective and should be considered.” Much has changed over the last decade, and the AAN no longer supports their use for PDN.

"Current evidence suggests that the risks of the use of opioids for painful diabetic neuropathy therapy outweigh the benefits, so they should not be prescribed," said lead author Brian Callaghan, MD, an associate professor of neurology at University of Michigan Health.

‘Probably’ Better Than Placebo

The only oral medications the AAN now recommends for PDN are gabapentinoids (pregabalin and gabapentin); serotonin-norepinephrine reuptake inhibitors (SNRIs) such as duloxetine; tricyclic anti-depressants such as amitriptyline; and sodium channel blockers such as valproic acid, which are usually used to treat seizures. An SNRI can also be combined with a weak opioid like tramadol for PDN.

There are caveats to all of these drugs since the evidence for them is limited and they were originally developed for other conditions such as depression or epilepsy. For example, the guidelines state gabapentin is “probably more likely than placebo to improve pain” and pregabalin is “possibly more likely” to help with PDN.

Topical medications such as capsaicin and buprenorphine patches also get the lukewarm endorsement of “possibly” being better than a placebo.

When one class of medication doesn’t work for PDN, experts say patients should try another.

“Managing expectations is also important,” Callaghan said. “Our second recommendation urges the provider to be frank with patients that the goal is to reduce their pain. It may not be possible to completely resolve the symptoms.”

A 2017 study by the Agency for Healthcare Research and Quality found that duloxetine (Cymbalta) and some other anti-depressants are moderately effective at relieving PDN, but found little or no evidence that opioids and gabapentinoids are helpful in treating neuropathic pain.

Researchers say a significant limitation for all pain relievers – not just opioids – is that few studies examine their safety and efficacy longer than three months. PDN is a progressive disorder that is likely to last a lifetime.  

“Given the chronicity of pain in those with diabetic neuropathy and the potential for evolving side effects, long-term studies are needed to better inform the long-term pain management in this population. Specifically, future studies should focus on the long-term effects (positive and negative) of opioids in this population to determine whether there is any role for these medications in this population,” the AAN’s expert panel concluded.