Painfully Stepping Over the Line

By Cynthia Toussaint, PNN Columnist

For decades, people have described me as indefatigable, super-human strong and the ultimate survivor. Or the one filled with surprises and miracles. Well-intended compliments that have moved me and, during dark times, spurred me on. But now these tributes vex me because I don’t know if I can live up to them.

Maybe I’m just tired of fighting the impossible.

My latest cascade of battles began in 2019, after getting a breast cancer diagnosis and not knowing whether I’d choose treatment due to Complex Regional Pain Syndrome (CRPS). While pushing back on my oncologist’s recommendations, she pulled out all stops in an effort to convince me to fight for my life. She asked, “Can you imagine yourself not doing treatment and regretting it?”

I furrowed my brow and replied, “I’m more concerned that I’ll do treatment and regret living with the damage afterward.”

I was terrified that cancer care, in all its cutting, burning and poisoning glory, would ignite a red-hot mess of CRPS, sending me back to my bedridden days and zeroing out any quality of life I’d clawed back over the decades.

I drew the line. To move forward with treatment, I had to have a life worth living at the other end.

I chose to only do chemo and miraculously lucked out, cancer and pain-wise. When my cancer returned a year and a half later, it appeared I’d skated by again, until I didn’t. While the immunotherapy knocked the tumor out in short order, little did I know that with each infusion my immune system was amping up to push me over the line, but in a way far worse than I could have imagined.

By mid-March, my lap swimming, my go-to for health and freedom, became a painful hell. I couldn’t push off during flip-turns, one leg barely kicked and my neck screamed in agony each time I turned for a breath. I had no choice but to quit.

Soon walking was near impossible: slow, labored and almost shuffling. My knees swelled to the point they wouldn’t allow me to get up from a chair or couch. Frantically, my partner, John, got a raised seat so I could use the toilet. I started losing weight because the pain in my jaw made eating torturous.

Screaming often through the days and nights, I felt hatchets and icepicks throughout my body, grinding glass replaced my joints. When I could sleep, I woke often with fever and chills.                   

After scads of labs, internet research and clinical assessments, I’ve learned that I’m the proud owner of a brand, spankin’ new disease: Reactive Inflammatory Arthritis. I’m now living the experience I feared most, the place where I told myself I couldn’t, wouldn’t go. I’ve stepped over the line, terrified it’s a one way ticket.      

To dampen the inflammation and stabbing pain, hell, just to get me moving, my doctors put me on low-dose naltrexone and prednisone (the latter I swore up and down I’d never revisit.) For that blessed comfort, the cost is mighty. I’m zonked out and joyless while insomnia, constant dizziness and the constipation-diarrhea seesaw zap my quality of life.

With the drug relief, I’m mercifully dipping into a warm therapy pool where I can move, walk and swim some, offering vague hope of recovery. But I see the troubled look in the eyes of my Y friends, the wish that their feisty, frothy friend would reemerge. I can’t help but wonder if they’re playing witness to my slow down and out.         

In my darkest hours, when the arthritic pain makes me question whether I can survive another five minutes, I rock with anger that my tumor’s gone. That was my ticket out. The jokes on me as I live the cancer-free dream. Cue the laugh track. I’m not living and free is nowhere to be found.

When my better angels reappear, I remember why I fought twice, tooth and nail, to see another day. I want to live, to love, and to see the beauty all around me. I want to continue to be a force for good.

Ahh, but that pesky line. I’ve got to get back over it. Or do I? When I got sick 40 years ago, I swore I wouldn’t live on if I couldn’t continue my showbiz career. I was utterly convinced life wouldn’t be worth a damn without it. Yet, here I am, staring down that line again. Maybe, MAYBE there’s some wiggle room one more time.     

I imagine all of us who’ve lived with high-impact pain over the long haul have drawn that line. Then later, took out an eraser and drew it again, renegotiating the terms. At another time, when we drop below, we grasp and beg as we slowly, savagely eek back over. Or not. It’s ever changing, tied to the whims of fate and will.

Maybe the line just gives us an illusion of control. Maybe it’s a frenemy, something that keeps us company whether we’re above or below.

This I know. I’m scared and tired while I stare down my new mountain. I’ve lost cherished independence, that may or may not return, requiring John to be on call at all times. We’re two generations removed since the last time I had to fudge the line, and what if my cancer returns? How many more comebacks can I stage?

Last night, I spewed anger with a close girlfriend, bristling that my impossibles never quell, despite being a good person. At that moment, something awoke in me. I was surprised to feel that old spark in my belly – which has me thinking that anger is serving me well right now.

It was so powerful when Heather commented, “I wouldn’t bet against you.”

I’ve learned that the best way to predict the future is by looking at the past. By that yardstick, I’ve always toed the line, come hell or high water. But like every other climb, I’ll decide what’s good enough, in my time, in my space.

Maybe I can live with that. 

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 and 19 comorbidities for four decades, and has been battling cancer since 2020. Cynthia is the author of “Battle for Grace: A Memoir of Pain, Redemption and Impossible Love.”

I’m Already Well Aware

By Mia Maysack, PNN Columnist

If I did not cling to my optimism for dear life, I'd scoff at the concept of an awareness month such as June being nationally recognized as Migraine & Headache Awareness Month.

That’s due to the fact I am someone who has lived with a daily reminder of intractable pain for over two decades. It isn’t those of us who can directly relate to the pain experience that are in need of awareness.

I feel many “awareness” efforts are limited or fall short in terms of gaining recognition for a specific cause or reason. People typically don’t concern themselves with issues that don’t directly affect or impact them.

Someone who hasn’t ever had a migraine couldn’t possibly understand how it differs from a regular stress headache. Furthermore, somebody who does experience an occasional migraine still cannot fathom what it would be like to have one on a more constant basis.

What transpires within and throughout our individual lenses of the world is real to us and valid, though different from others. That doesn’t lessen the next person’s experience as being anything less than our own.    

There have been some who have thought of my claims about illness are disingenuous. But the reality is that I actually learned to “fake” wellness, in an effort to create a sense of fulfillment and meaning in my life, despite the hand I’ve been dealt.

Others claim those of us who live with pain should be able to “fix” ourselves, once we acknowledge things like a childhood trauma; or that if we adopt “sufficient water intake” and “sleep hygiene” for example, all will be well.

Although I believe there’s some merit to those suggestions, and that they come from a decent, well-meaning place --- if it were that simple, I would be healed by now, along with millions of others who endure similar circumstances.

For a lot of us, we’ve had to come to terms with the fact that there may not be anything out there to give us back the life we once had or wanted. That’s because we’ve already attempted and tried just about everything in search of pain management or relief.

Often, we’re unable to obtain access to options that might ease our suffering because that process can be a grueling one and often has a ripple effect of further complications, along with a multitude of hoop jumping. That’s why I’ve mostly refrained from making it a habit to ask for professional help. Instead, I have worked on acceptance, as there are not many things that anyone else can do for me.   

Relentless and untreatable ailments in any form are going to take a toll, but I hold steady to the concept of “pain” being a worldwide experience that each and every one of us can relate to in some way or another. Each of us have had moments when we’d do just about anything to have the discomfort end.

But instead of embracing the potential for common ground, we as a society tend to label people, when the cure is to be found in seeing and treating one another as fellow human beings. We never truly know where a person may be in regards to their mental health or quality of life, and need not make this already challenging existence any more difficult for ourselves or each other.

Given the extent I’ve witnessed how our healthcare system fails us, I had to choose to not identify with the victim mentality or wait any longer for answers elsewhere.  Ultimately, I stumbled upon empowerment in owning my situation, by tending to myself in ways that I am able. That was my education in self-awareness.

Mia Maysack lives with chronic migraine, cluster headache and fibromyalgia. She is the founder of Keepin’ Our Heads Up, a Facebook advocacy and support group, and Peace & Love, a wellness and life coaching practice for the chronically ill. 

What If Pain Had a Color?

By Carol Levy, PNN Columnist

What if your pain had a color? Not a color picked to honor an awareness day or month, but an actual color?

I could walk into the doctor's office. “I understand you have pain. Where is it located?” he’d ask. I’d point to the area. It was a bright chartreuse, as blinding as a neon sign.

“Oh yes. You definitely have pain. Let's see what we can do about that,” the doctor would say.

Wouldn’t that be simpler, easier? Unfortunately, it isn’t.

After the trigeminal neuralgia pain started near my eye, I was referred to a neuro-ophthalmologist. Our first meeting did not go well. The level of pain, the resulting disability, and its effect on me made it hard to tell my story in a calm and thoughtful way.

Stopping to collect my emotions, gather my thoughts and make sense of what made no sense, I started and stopped, my words coming in fits and starts. I struggled to control my emotions and not cry.

After a few minutes he stopped me. “Stop being so schizophrenic in how you're telling me your story,” he said. “Your pain is the result of anxiety.”

I didn't understand what he meant. No pain like mine could just be the result of nerves. He wrote a prescription for an anti-anxiety drug, but that only increased my stress, and the anger I felt towards the pain and medical profession.

Undaunted and with hope unfettered, I kept the next appointment. Again, he listened. He still seemed unimpressed with my pain and my story. But his interest was piqued by a birthmark on my forehead directly over the area of the pain. He noticed it would turn a brighter shade of red during various times of the appointment.

I was prissy back then. I hated cursing and embarrassed easily. He was not averse to using profanity, and just one or two words was too much for me. When he cursed, the birthmark would turn bright red. That changing of color and in the way my pain was triggered changed his feeling about my pain. He seemed more interested in it.

“I think it's time we bring you into the hospital,” he told me.

In those days, a doctor at a teaching hospital would be trailed by medical students, interns and residents. Like goslings imprinting on their mother, they followed the doctor everywhere.

When the group came to my room, the doctor wanted them to see how and when the birthmark changed color. He explained to them it was an outward sign of a neurovascular birth defect that he believed was the cause of my pain.

It was a teachable moment and the doctor liked milking it. He knew how easily I was embarrassed and how that would change the coloring of the birthmark. To get it to turn bright red, he jokingly threatened to expose himself (this was in the 1970’s). Immediately it changed color. I was so embarrassed.

It got to the point where all he had to say was, “I'm going to…” And like Pavlov’s dog, the birthmark turned bright red. He did that trick for his lot of ducklings, who were amazed.

My pain still did not have a color, but the changing color of the birthmark showed a visible, anatomic reason for it. It made my pain more real to others. If not for the birthmark and the trick of turning it off and on, the correct treatments might not have been tried.

Cancer patients have lumps or growths. Jaundice turns you yellow. Us? We have nothing but our word. Until pain has a color, our word has to be enough.

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

Mood Disorders May Be Early Sign of Chronic Fatigue

By Pat Anson, PNN Editor

Anxiety, depression and other mood disorders have long been associated with fibromyalgia, irritable bowel syndrome (IBS), and chronic fatigue syndrome (CFS). That’s not altogether surprising, since the three chronic illnesses cause body pain, insomnia, fatigue, and other stressful symptoms that can trigger a psychological reaction. No one likes being sick, after all.  

But a large new study found that psychiatric disorders preceded the development of fibromyalgia, IBS and CFS in about a quarter of the people who have the conditions – more than those who suffer from similar chronic illnesses. Anxiety and depression were significantly more common in people who were later diagnosed with chronic fatigue.

"This work provides evidence that for many people, a wide variety of physical and psychological factors are associated with these debilitating conditions," says Francis Creed, a professor emeritus of psychiatry at The University of Manchester.

Creed analyzed over two years of health data from over 120,000 people who participated in the Dutch Lifelines cohort study; comparing the data of people with fibromyalgia, IBS and CFS to those with diabetes, inflammatory bowel disease (IBD) and rheumatoid arthritis. The latter group had similar symptoms and served as a control.

Creed’s findings, recently published in the journals PLOS ONE and Frontiers in Psychiatry, showed that psychiatric disorders were more common (17–27%) in the first group than in the control group (10.4–11.7%).

General anxiety disorder (GAD), panic disorder, dysthymia, major depressive disorder (MDD) and agoraphobia were particularly more common in people who were later diagnosed with CFS.  

PLOS ONE

Creed says a number of physical and mental health issues may be at work in the development of fibromyalgia, IBS and CFS. He favors a holistic approach to treating them, including a mental health evaluation.   

"When people suffering from CFS/ME, IBS and fibromyalgia come into contact with health professionals, negative attitudes can sometimes get in the way of treatment. but by understanding these complex conditions better, the stigma and mystery around them can be eased," he said.

"Although there are symptomatic treatments which may help these unexplained disorders, we should aim to understand fully their underlying causes. There are probably several different ways they may develop; a whole range of physical and mental factors are probably involved. Treatment approaches will become more effective as our understanding of the causes improves."

Association is not causation, and it’s important to note that about three-quarters of the people who developed fibromyalgia, IBS and CFS did not have any mood disorders prior to the onset of their illnesses.   

Creed says future research and clinical work should focus on possible interactions between psychiatric disorders and other behavioral variables to identify the true role of anxiety and depression in chronic illness.

Chemotherapy and Opioid Shortages Impacting Cancer Care

By Pat Anson, PNN Editor

Over two-thirds of cancer centers in the U.S. are reporting shortages of methotrexate and other drugs used in chemotherapy, according to a survey by the National Comprehensive Cancer Network (NCNN).

Methotrexate is a versatile drug that prevents cells from dividing. It was originally developed to treat cancer, but is also widely used to treat autoimmune and neurological conditions such as lupus, rheumatoid arthritis, migraine and multiple sclerosis.

The NCNN surveyed 27 cancer centers across the U.S. in late May, and found that 67% of them were reporting shortages of methotrexate. Most centers are also reporting chronic shortages of carboplatin and cisplatin, chemotherapy agents that are widely used in cancer treatment. The shortages have resulted in treatment delays or forced doctors to modify their treatment plans using other drugs.

"This is an unacceptable situation. We are hearing from oncologists and pharmacists across the country who have to scramble to find appropriate alternatives for treating their patients with cancer right now," Robert Carlson, MD, CEO of NCCN, said in a statement. "We were relieved by survey results that show patients are still able to get life-saving care, but it comes at a burden to our overtaxed medical facilities." 

Drugs shortages in the U.S. are currently near record levels, primarily due to shipping delays and other disruptions caused by the pandemic. But the shortage in chemotherapy agents largely stems from a halt in production at a plant in India operated by Intas Pharmaceuticals. FDA inspectors found quality-control violations at the plant late last year and the agency recently slapped an import alert on the company. The agency is working with drug makers in China to make up the difference.

The FDA added methotrexate injectable solution to its drug shortage list in March. Supplies are currently limited and the shortage is not expected to end until December 2023. No shortages are currently reported for methotrexate tablets.

Hydrocodone Shortage

In addition to chemotherapy drugs, some drug makers are also reporting shortages of opioid pain medication. The American Society of Health-System Pharmacists (ASHP) recently added hydrocodone-acetaminophen combinations – commonly known under the brand names Vicodin and Norco-- to its own drug shortage database.

Generic drug makers Amneal, Camber, KVK-Tech, Major and Rhodes currently report shortages of 5 mg, 7.5 mg, and 10 mg hydrocodone tablets. None of the companies provided a reason for the shortage or an estimate for when it might end. Many of the same drug makers reported shortages of oxycodone in March.

The limited supply of opioids is also affecting cancer patients. The University of Utah Health system recently informed its drug wholesaler that it was adding 50 new beds to its cancer clinic and would be needing more pain medication to treat the extra patients.

“And the wholesaler said, ‘Well, let's just wait until we start receiving your orders to increase the amounts that you're going to buy,’” said Erin Fox, PharmD, Senior Pharmacy Director at University of Utah Health, which tracks drug shortages for the ASHP. “We're unable to be proactive. We're trying to think ahead. And we don't want to have that situation where we we're getting very close to running out or not having enough. That's basically what our wholesaler says has to happen.”

“We wish that we could fix all these things, but we don't make the medicines and we can't tell someone that they must make medicines. There are some things that are out of our control,” FDA Commissioner Robert Califf, MD, said in a recent interview with Medscape.

The Drug Enforcement Administration, in consultation with the FDA, sets the annual production quotas for opioids and other controlled substances. The DEA reduced this year’s supply of oxycodone and hydrocodone by about 5 percent, after being advised by FDA that demand for Schedule II opioids would decline. Since peaking a decade ago, DEA production quotas have fallen by 65% for oxycodone and 73% for hydrocodone.

Massage Therapists Ease Pain of Hospice Patients — But Are Hard to Find

By Kate Ruder, KFF Health News

Ilyse Streim views massage for people in hospice care as “whispering to the body through touch.”

“It’s much lighter work. It’s nurturing. It’s slow,” said Streim, a licensed massage therapist.

Massage therapy for someone near the end of life looks and feels different from a spa treatment. Some people stay clothed or lie in bed. Others sit up in their wheelchairs. Streim avoids touching bedsores and fresh surgery wounds and describes her work as “meditating and moving at the same time.”

She recalled massaging the shoulders, hands, and feet of one client as he sat in his favorite recliner and watched baseball on TV in the final weeks of his life.

“When you’re dying and somebody touches you without expectation of anything in return, you just get to be,” said Streim.

Massage therapists like Streim, who specializes in working with people who are dying or have an advanced form of cancer or other illness, are rare. Fewer than 1% of therapists specialize in hospice or palliative care massage, according to research by the American Massage Therapy Association, although many more may periodically offer massage for hospice patients.

Streim has a private practice in Lafayette, Colorado and her clients pay her out-of-pocket, as Medicare and private insurance typically don’t cover massage therapy. She also volunteers as a hospice massage therapist four hours a month.

It’s common for hospice organizations to use volunteer therapists for treatments, though some massage therapists, with physicians backing them, are pushing for paid positions as part of medical teams working alongside nurses and social workers.

In the hospice unit at Palo Alto VA Medical Center, in Palo Alto, California, for example, massage therapists have been integral members of the multidisciplinary team for decades, said VJ Periyakoil, a professor of medicine at Stanford University and the founding director of its palliative care education and training program.

The covid-19 pandemic made the recruitment of specialists for this intimate work, both paid and volunteer, more difficult, as the pool of massage therapists shrank amid school closures and exits from the profession. There are up to 10% fewer massage therapists today than before the pandemic, according to Les Sweeney, president of Associated Bodywork & Massage Professionals.

“It’s still hard for us to hire and recruit therapists,” said Kerry Jordan, operations director at Healwell, a nonprofit that trains and employs massage therapists to work in hospitals in the Washington, D.C., area.

‘We Need to Get More Therapists’

For three weeks in April 2020, licensed massage therapist Cindy Spence, who works at Faith Presbyterian Hospice in Dallas, could not massage patients due to the state’s lockdown orders. Then, the state granted an allowance for massage therapists like her, working in medical settings under supervision, to resume giving massages. But it took several months for many therapists to return to work, and some didn’t return at all, Spence said.

“The pandemic was not kind to massage therapists,” Spence said. “And so we have lost a lot of people like me who are of an age and experience level that would really be called to and suitable” for oncology, hospice, and palliative massage.

“We need to get more therapists trained,” she said. She described receiving several calls each month from people who have found her name online. It has become harder since covid to find a therapist to refer them to, Spence said.

At TRU Community Care, which operates in several locations in Colorado, Volunteer Services Supervisor Wendy Webster said massages are a top request from patients and their families, but they’re limited in how many sessions they can offer, with only two volunteer massage therapists. (A third volunteer did not return after the pandemic.)

Finding new massage therapist volunteers is challenging, said Webster, in part because they can earn money in other settings and “they’re coming to us for free.” Thirty years ago, TRU Community Care’s nonprofit status was the norm, but now the majority of hospices are for-profit, with growing investment from private equity.

Despite that shift, hospices still rely heavily on volunteers. Medicare pays for at least six months of hospice for a patient on the condition that providers use volunteers for at least 5% of the patient-care hours worked by paid staff and contractors. Sometimes, those volunteer hours are filled by massage therapists.

“All hospices, not-for-profit or for profit alike, should aim to include medically-trained massage therapists as part of best holistic care,” Hunter Groninger, a professor of medicine at Georgetown University who directs palliative care at MedStar Washington Hospital Center in Washington, D.C., wrote in an email. Employing these specialists is beneficial and does not diminish the important service of volunteers, particularly in end-of-life care, he added.

Benefits of Massage

More studies on the impact of specialized massage could enact changes in the field, said Cal Cates, founder and executive director of Healwell, which, since 2009, has trained 500 therapists in hospital-based and oncology massage, as well as in how to work collaboratively with doctors and nurses.

In a recent clinical trial of 387 patients in palliative care at MedStar, including some nearing the end of their lives, Groninger, Cates, Jordan, and other co-authors found that massage therapy improved quality of life.

Despite new research on the benefits of massage, Cates said, many hospices bring on volunteers who don’t have advanced training, because hospices may not know that specialized training — such as the kind Healwell offers — exists.

Streim, who paid for her own classes in oncology and lymphatic massage, said that investment in education qualified her for a six-year career as an oncology massage therapist at Good Samaritan Medical Center’s Center for Integrative Medicine in Lafayette and later her private practice. She teaches classes in adapting massage for the elderly and those with illnesses at Boulder Massage Therapy Institute. In her 39 years as a therapist, Streim has done it all: volunteer, staff, entrepreneur, teacher.

Like Streim, Spence has continually redefined her role. She began in private practice before becoming an employee of a large hospice agency in which she traveled across nine counties in Texas, giving thousands of massages to people dying in their homes, assisted living communities, and skilled nursing homes. Today, at Faith Presbyterian Hospice, she is one of three licensed massage therapists on staff and fully integrated as an employee of the organization, which has more than 100 patients.

“Those of us who do this work have made big investments in our profession and I’m glad to see that we can be paid for it,” she said.

Spence collects data on how patients rate their pain on a scale of 1 to 10 before and after a massage. Most fall asleep during the massage, which she takes as an indication their pain has lessened or they became more relaxed. Of those who stay awake, almost all say their pain subsided significantly or went away completely.

That kind of positive engagement with providers is more urgent than ever since the pandemic, Groninger said. Spence agreed: “The pandemic taught us all, in a very painful way, what it’s like to be deprived of human touch and human connections.”

Sometimes the nursing staff at Faith Presbyterian will roll a bed out onto the patio so a patient can hear the sounds of nature and the fountain gurgling during Spence’s massage. There is more teasing and laughter than she would have imagined. For patients unable to speak, Spence watches their reactions carefully: a deep exhalation or the face and body softening. Sometimes it’s tears running down their cheeks.

“It’s profound, helping someone find safe breaths along this very difficult dying journey,” she said.

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

Primary Care Providers Still Reluctant to Talk About CBD

By Pat Anson, PNN Editor

Edibles, beverages and other products made with cannabidiol (CBD) went mainstream years ago, as public attitudes about cannabis changed and retailers discovered there was a growing market for CBD products.

The same is not true for primary care providers, according to a new survey that found most doctors are still reluctant to recommend CBD to their patients because of doubts about its safety and effectiveness. CBD is a chemical compound in marijuana that does not produce euphoria, but is believed to reduce pain and improve other health conditions.  

In the online survey of 236 primary care providers (PCPs) affiliated with the Mayo Clinic Healthcare Network in Minnesota, Wisconsin, Florida and Arizona, doctors said CBD was frequently brought up during medical appointments, usually by patients. But those conversations didn’t last long, because most PCPs don’t feel they have enough knowledge about CBD and are skeptical about CBD marketing claims.

PCPs in states where marijuana is legal are more receptive to patients using CBD products, while PCPs in states where marijuana is still illegal are more concerned about CBD’s side effects. But regardless of its legal status, most PCPs believe CBD is ineffective for most conditions for which it is marketed, with chronic non-cancer pain and anxiety/stress being the exceptions.

“Results from this mixed methods study show that PCPs practicing in the U.S. rarely screen for or discuss CBD use with their patients and report several barriers to engage in proactive CBD-focused practice behaviors,” wrote lead author Pravesh Sharma, MD, a pediatric psychiatrist and substance use researcher at Mayo Clinic Health System.

In a second, much smaller study, Sharma and his colleagues conducted interviews with 14 PCPs and found a number of barriers that prevent an open dialogue about CBD, including lack of time, discomfort, low-quality evidence, and CBD being a low priority.

“Our study is the first in-depth report on PCP attitudes, experiences, and practice behaviors related to CBD. The findings of our study have the potential to significantly impact future PCP practice behaviors,” they concluded.

The U.S. market for legal cannabis has grown into a $29.6 billion industry, but not much has changed over the years in terms of its acceptance in the medical community. In a 2020 survey of over 1,000 primary care patients in Vermont, only 18% rated their doctor as a good source of information about cannabis. Nearly half of the patients surveyed had used cannabis in the last year, and most of them thought cannabis was helpful for pain, anxiety, depression, arthritis, sleep and nausea.

The effectiveness of CBD is somewhat murky, because CBD products are poorly regulated and vary so much in dose, quality and whether they also have THC. While CBD may be effective temporarily in relieving pain and other symptoms, some researchers are concerned about its long-term effects on children and adolescents.  

“In fact, although CBD is widely available as an unregulated supplement, we researchers know almost nothing about its effects on the developing brain. Of note, these harms apply not only to smoking, but also to ingesting, vaping or other ways of consuming cannabis or its extracts,” Hilary Marusak, PhD, a psychiatry professor at Wayne State University, said in a recent column.

“In my view, it’s important that consumers know these risks and recognize that not everything claimed in a label is backed by science. So before you pick up that edible or vape pen for stress, anxiety, or sleep or pain control, it’s important to talk to a health care provider about potential risks.”

Unfortunately, asking a doctor may not provide many answers.

Let’s Talk About Chronic Pain and Sex

By Ann Marie Gaudon, PNN Columnist

Do you remember that catchy song from the early 90’s by the hip hop group Salt-N-Pepa called “Let’s Talk About Sex”? I sure do and I still think it’s fun!

For many people, sexual activity and intimacy are incredibly important factors of living well, being happy, and feeling close to one another. But when chronic pain enters a life, those factors may take a big hit. People don’t talk enough – or at all – about living in pain and sexual intimacy.

Let’s talk now baby!

In my many years of being with people in pain, I’ve seen sex become a taboo subject. It can be denied not only to another, but to oneself as well. It gets complicated when the person in pain worries about their physical performance or if they can even engage in sexual activity without increasing their pain.

This most certainly affects self-esteem and confidence in the bedroom. Then we have a situation where everybody stops talking -- when they should be doing just that.

Why does sex matter if you have chronic pain?

It matters and can have a significant impact on your quality of life. Something amazing happens when you are the recipient of wanted sexual touching and intimacy. Your body will release endorphins, which are the body's natural pain reducers. You will feel better and happier, not to mention all those other good feelings you may experience.

The name endorphin comes from “endogenous morphine,” which means they come from inside the body and mimic the effects of morphine. For that reason alone, I tell my clients to have more sex if possible. And if they are single, to get busy masturbating. An orgasm is an orgasm, and your body doesn’t care how it gets there. Just get there.

In 2017 a functional MRI study was conducted measuring brain activity in women during orgasm. “Brain activity gradually increased leading up to orgasm, peaked at orgasm, and then decreased,” researchers found. This activation included many regions of the brain, including those that process rewarding experiences such as food and sex. 

Another study from 2013 shows that orgasm may have the ability to decrease or alleviate headache pain. Want better sleep? Have regular orgasms. Yet another study in 2015 showed the mediating effect of sexual activity on pain and depression for those suffering from low back pain.  

How are you going to have sex if you have back pain?

I found out that the clinical community was in contact regularly with Canadian Dr. Stuart McGill, Chief Scientific Officer for Backfitpro and a distinguished professor emeritus at Waterloo University. McGill is asked repeatedly by clinicians about couples who are celibate because of back pain. Are there any guidelines on sexual technique that can reduce the risk of more pain?

The challenge was on! Professor McGill and graduate student N. Sidorkewicz conducted the only study in the world that took real couples and measured their spine postures and muscle activity while engaged in various sexual positions. This was no small feat, considering the challenges of recruitment, instrumentation and developing an experimental protocol that satisfied the ethics research committee and requests from the medical community. 

The study measured muscle activity and 3D spine and body movements, using the very same technology that was used in the making of Avatar. The object was to create an atlas of sexual positions that did not trigger back pain.

Professor McGill has a short version of a sexual atlas in his book "Back Mechanic," which includes spine-sparing positions that enable sex for people with back problems. The book guides the reader through a self-assessment of their pain triggers. Then, based on the specific trigger, positions and movements are shown to consider and to avoid.

I am super impressed with this work and I only wish that we had guidelines for virtually every source of pain.

Are there other pain conditions that defy sexual activity?

You bet there are! One that comes to mind is pelvic floor dysfunction or PFD. I have known many people with this diagnosis. We all have a pelvic floor, whether you were born with a penis or vagina, and so no one is immune to PFD.

One female patient with this diagnosis -- more specifically “hypertonic pelvic floor muscles” -- told me that just a light touch and/or engorgement from arousal can be enough to create excruciating muscle spasms.

“Spasms beget spasms,” she said. “It is very, very painful and truly sad that we avoid intimacy. I have a Pavlovian response developed over many years of severe pain and flares that lasted for days.”

The forceful, rhythmic contractions that occur for anyone having an orgasm can set off a cascade of painful symptoms. Here are links two simple videos to explain male and female pelvic pain.

PFD is currently treated by specialized physical therapists and yes – there are success stories, thankfully.

How do I get busy?

As a person with any type of pain, you may need to get creative. You may need to adjust positions for yourself or your partner, as well as the time, day and even the environment. If you require minimum body movement, consider self-stimulation while lying beside your partner. Sex toys and lubricants also work wonders, whether you have a partner or are alone.

If being spontaneous is not in the plan, consider making intimate dates either with a partner or yourself. Above all, keep the communication open with your partner. It’s crucial that you understand each other and have realistic expectations without judgment.

If you’re wondering if you can share intimacy without the orgasm, the answer is yes! Orgasm is only one aspect of sexual intimacy, and you can connect and feel great in plenty of other ways.

There comes a time in many couple relationships when sexual intercourse isn’t an option, due to physical, emotional or mental health. When this occurs, there are many alternatives to consider. Make a list for yourself, considering your unique needs, which will support and care for your pained body no matter what stage in life you are in. 

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. 

FDA Head Says Drug Shortages ‘Out of Our Control’

By Pat Anson, PNN Editor

With drug shortages in the U.S. near record levels, the head of the Food and Drug Administration says there is little his agency can do to ease shortages, particularly those involving generic drugs.

“We wish that we could fix all these things, but we don't make the medicines and we can't tell someone that they must make medicines. There are some things that are out of our control,” FDA Commissioner Robert Califf, MD, said in an interview with Medscape.  

There are currently 207 medications in short supply, according to the FDA’s drug shortage list, but the American Society of Health-System Pharmacists (ASHP) has a much higher estimate of over 300 active drug shortages, the most since 2014.

Shortages of generic medications used to treat cancer and attention deficit disorder (ADHD) have gotten the most attention, but there are also emerging shortages of generic oxycodone and other opioid pain medications. About 90% of prescribed drugs in the U.S. are low-cost generics.

“And this has caused a big problem, where a number of generic drugs are in shortage at any given time, because there's not enough profit for a company to say they want to go into the business of making that drug,” said Califf.

Teva Pharmaceutical, one of the world’s largest manufacturers of generic drugs, announced last month that it would change its business model to focus on more profitable branded drugs. Teva has already informed the FDA that it was discontinuing production of 30, 15, and 5 mg tablets of generic oxycodone.  

Another generic drug maker, Perrigo Pharmaceuticals, recently notified the FDA that it was stopping production of a cough syrup made with hydrocodone.

Pain patients have had trouble for years getting prescriptions filled for opioids, but the problem appears to have gotten more acute in recent months – and not just for generic opioids. Joy CobbWilliams told PNN she has trouble getting prescriptions filled for OcyContin, a branded formulation of oxycodone that she’s been taking for nearly a decade for chronic back pain.

“Month after month I run out of my medication while I wait for the pharmacy to get more. Some months I wait three or four days and other months I wait almost two weeks. The pain I suffer is unbearable,” she said. “Something needs to be done. We have got to do better for the patients suffering and not abusing the medication. This is the United States and there should be no reason someone suffering should have to wait days to weeks to get their 10mg OxyContin.” 

Kim Luarks told us she’s had problems with her pharmacy running out of fentanyl patches and Xtampza ER (oxycodone). She’s been on opioids for 20 years due to chronic back pain. 

“Here I sit, still waiting and have been without any long-acting opioid for (7 days) and not feeling too hot,” she said. “This could be detrimental to my life, let alone my heart and lungs that are already damaged due to the doctors just throwing pain meds at me in the early 2000’s. I've been through all the changes and federal regulations causing this nonsense.” 

The Drug Enforcement Administration, in consultation with the FDA, determines the annual production quotas for opioids and other controlled substances. Despite Califf’s contention that drug shortages are “out of our control,” it was the FDA that advised the DEA that demand for Schedule II opioids such as oxycodone would fall by 5.3% in 2023. 

DEA adopted the FDA’s recommendations and reduced the supply of opioids for the seventh consecutive year, saying it would be “sufficient to meet all legitimate needs.” Since their peak in 2013, DEA production quotas have fallen by 65% for oxycodone and 73% for hydrocodone.

In his interview with Medscape, Califf suggested that some medications are now in short supply not because of production quotas, but because they are prescribed to people who don’t really need them. He said stronger medical guidelines may be needed to discourage doctors from overprescribing.   

“If only the people that needed these drugs got them, there probably wouldn't be a shortage. There's a large amount of use which is on the margins. And this is why I say we need better clinical standards,” Califf said.

“But having said all that, we're working with the DEA frequently as they try to work out what the quotas are. And we're working with the companies to optimize production. So that shortage should go away. It's better now than it was a few months ago, and it's going to continue to get better.”

Studying Natural Opioids Could Lead to New Non-Addictive Analgesics

By Dr. John Streicher, University of Arizona

Opioid drugs such as morphine and fentanyl are like the two-faced Roman god Janus: The kindly face delivers pain relief to millions of sufferers, while the grim face drives an opioid abuse and overdose crisis that claimed nearly 70,000 lives in the U.S. in 2020 alone.

Scientists like me who study pain and opioids have been seeking a way to separate these two seemingly inseparable faces of opioids. Researchers are trying to design drugs that deliver effective pain relief without the risk of side effects, including addiction and overdose.

One possible path to achieving that goal lies in understanding the molecular pathways opioids use to carry out their effects in your body.

What Are Natural Opioids?

The opioid system in your body is a set of neurotransmitters your brain naturally produces that enable communication between neurons and activate protein receptors. These neurotransmitters include small protein-like molecules like enkephalins and endorphins. These molecules regulate a tremendous number of functions in your body, including pain, pleasure, memory, the movements of your digestive system, and more.

Opioid neurotransmitters activate receptors that are located in a lot of places in your body, including pain centers in your spinal cord and brain, reward and pleasure centers in your brain, and throughout the neurons in your gut. Normally, opioid neurotransmitters are released in only small quantities in these exact locations, so your body can use this system in a balanced way to regulate itself.

The problem comes when you take an opioid drug like morphine or fentanyl, especially at high doses, for a long time. These drugs travel through the bloodstream and can activate every opioid receptor in your body. You’ll get pain relief through the pain centers in your spinal cord and brain. But you’ll also get a euphoric high when those drugs hit your brain’s reward and pleasure centers, and that could lead to addiction with repeated use. When the drug hits your gut, you may develop constipation, along with other common opioid side effects.

Targeting Opioid Signals

How can scientists design opioid drugs that won’t cause side effects?

One approach my research team and I take is to understand how cells respond when they receive a message from an opioid neurotransmitter. Neuroscientists call this process opioid receptor signal transduction. Just as neurotransmitters are a communication network within your brain, each neuron also has a communication network that connects receptors to proteins within the neuron.

When these connections are made, they trigger specific effects like pain relief. So, after a natural opioid neurotransmitter or a synthetic opioid drug activates an opioid receptor, it activates proteins within the cell that carry out the effects of the neurotransmitter or the drug.

Opioid signal transduction is complex, and scientists are just starting to figure out how it works. However, one thing is clear: Not every protein involved in this process does the same thing. Some are more important for pain relief, while some are more important for side effects like respiratory depression or the decrease in breathing rate that makes overdoses fatal.

So what if we target the “good” signals like pain relief and avoid the “bad” signals that lead to addiction and death? Researchers are tackling this idea in different ways. In fact, in 2020, the U.S. Food and Drug Administration approved the first opioid drug based on this idea, oliceridine, as a painkiller with fewer respiratory side effects.

However, relying on just one drug has downsides. That drug might not work well for all people or for all types of pain. It could also have other side effects that show up only later on. Plenty of options are needed to treat all patients in need.

Inhibiting a Protein Relieves Pain

My research team is targeting a protein called Heat shock protein 90, or Hsp90, which has many functions inside each cell. Hsp90 has been a hot target in the cancer field for years, with researchers developing Hsp90 inhibitors as a treatment for many cancer types.

We’ve found that Hsp90 is also really important in regulating opioid signal transduction. Blocking Hsp90 in the brain blocked opioid pain relief. However, blocking Hsp90 in the spinal cord increased opioid pain relief. Our recently published work uncovered more details on exactly how inhibiting Hsp90 leads to increased pain relief in the spinal cord.

Our work shows that manipulating opioid signaling through Hsp90 offers a path forward to improve opioid drugs. Taking an Hsp90 inhibitor that targets the spinal cord along with an opioid drug could improve the pain relief the opioid provides while decreasing its side effects. With improved pain relief, you can take fewer opioids and reduce your risk of addiction. We are currently developing a new generation of Hsp90 inhibitors that could help realize this goal.

There may be many paths to developing an improved opioid drug without the burdensome side effects of current drugs like morphine and fentanyl. Separating the kindly and grim faces of the opioid Janus could help provide the pain relief we need without addiction and overdose. 

John Streicher, PhD, is an Associate Professor in the Department of Pharmacology at the University of Arizona. Dr. Streicher has published over 70 peer-reviewed articles and is engaged in numerous drug discovery campaigns to create new analgesics. He receives funding from the National Institutes of Health, the Arizona Biomedical Research Commission, the Flinn Foundation, and the University of Arizona.

This article originally appeared in The Conversation and is republished with permission.

Medical Cannabis Effective but Expensive for New Zealanders

By Pat Anson, PNN Editor

Medical cannabis is very effective at relieving pain, improving sleep and reducing anxiety, according to researchers in New Zealand, who say government policies need to change to make cannabis cheaper and more accessible to Kiwis.

Researchers at the University of Otago, Victoria University and the University of Auckland surveyed and conducted interviews with 213 people who had prescriptions for cannabis under New Zealand’s medical cannabis program. Participants were asked about the quality of cannabis products they used and their effectiveness.

The study findings, published in the journal Drugs, Habits and Social Policy, show that nearly 96% reported that cannabis helped them with their medical conditions. Almost half (49%) said they were able to reduce or stop taking prescription drugs.

The most common therapeutic use of medical cannabis was pain relief and 96% of participants said it helped reduce their pain. Cannabis also helped users who had difficulty sleeping (97%) and those with mental health issues (98%).

Of the participants who took cannabis for other reasons, such as autism, attention deficit hyperactivity disorder, post-traumatic stress disorder, and difficulty eating, 98% found cannabis helpful.

"An important finding of the study was that participants either decreased or stopped their use of prescribed medicines, many of which were opioid based," said co-author Geoff Noller, PhD, a Research Fellow at Otago University's Dunedin School of Medicine. "This both reinforces that they experienced some actual effect from using cannabis in that they ceased or decreased other medications with recognized efficacy, and in the case of many of these other medications, they reduced their use of potentially more problematic medications.

"There is a place for both approaches, with the results of this study suggesting that cannabis products could have a role in treating patients with chronic pain and other conditions refractory to treatment by conventional means."

But many New Zealanders find medical cannabis difficult to obtain and rely on the black market. A recent study by the NZ Drug Foundation estimated that while over a quarter of a million Kiwis use cannabis for medical reasons, only 6% -- about 17,000 people -- obtained cannabis with a prescription.

Many doctors won’t prescribe medical cannabis and there are a limited number of products on the market, keeping prices high. The Foundation said CBD oil can cost a patient $150-350 per month, with other cannabis products costing even more.

"At present, current regulations appear to be creating problems for many New Zealanders who otherwise report positive benefits from their use of medicinal cannabis,” says Noller. "Specific barriers include cost, with currently available medicinal cannabis products being too expensive for many New Zealanders due to the compliance costs of production imposed by regulations, and also the lack of knowledge about it for physicians, leading to a reluctance to prescribe, in many cases."

To obtain medical cannabis, New Zealanders need a prescription from a doctor that spells out what cannabis products can be used and the amount. Medical cannabis can only be obtained legally from a doctor or pharmacy, although many Kiwis use a “Green Fairy” – a person who provides cannabis for a nominal fee.

Ketamine Nasal Spray May Be Effective Migraine Treatment

By Pat Anson, PNN Editor

In recent years, ketamine has become a trendy drug for treating depression, anxiety, post-traumatic stress and some types of chronic pain. Usually administered by infusion or injection, ketamine is a non-opioid analgesic that acts on the brain by putting patients into a temporary dream-like state.

A new study at Thomas Jefferson University suggests that ketamine may also be an effective treatment for chronic migraine. Several previous trials have shown that intravenous ketamine is effective for chronic headache, but it required close monitoring by a pain specialist to adjust the dose and monitor any side effects.

In the new study, researchers gave 169 migraine patients a ketamine nasal spray that they could use at home without supervision. Over two-thirds of the participants suffered from daily headaches and nearly 85% had tried over 3 types of migraine prevention drugs, with limited success.

The study findings, published in the journal Regional Anesthesia & Pain Medicine, showed that nearly half the participants said the nasal spray was “very effective” and about 40% found it “somewhat effective.” Over a third said their quality of life was “much better.” 

Nearly 3 in 4 patients reported at least one side effect from ketamine, the most common being fatigue and double/blurred vision, followed by cognitive effects such as confusion, dissociation, vivid dreams and hallucinations. Most of the side effects were only temporary.

“In this descriptive study, intranasal ketamine served as an acute treatment for refractory chronic migraine by reducing headache intensity and improving quality of life with relatively tolerable adverse events. Most patients found intranasal ketamine effective and continued to use it despite these adverse events,” wrote lead author Michael Marmura, MD, Outpatient Director at the Jefferson Headache Center.

Marmura and his colleagues are cautious about who should use ketamine because of its potential for abuse. Ketamine has a short half-life of less than two hours, meaning patients may be tempted to use it repeatedly to keep chronic headaches at bay. Patients in this study used the nasal spray an average of just 6 times a month, but a small number (13.9%) used the spray daily.

“Clinicians should only consider the use of a potentially addictive medication such as ketamine for significantly disabled patients with migraine,” they warned. “(This) should be addressed carefully and individually, as some may respond only to repeated ketamine, while some may overuse it.”

In 2019, the FDA approved the use of Spravato, a nasal spray that contains a ketamine-like substance, for severe depression. Because of the risk of abuse, Spravato can only be administered in a doctor’s office, where patients can be observed for two hours after taking a dose. The use of such a spray to treat migraine would be considered an off-label use.

In addition to its medical uses, ketamine has long been known as a party drug – “Special K” -- because it can cause hallucinations and intense, dream-like states.

It didn’t take long for drug dealers to note the increase in ketamine’s popularity. Recent research published in JAMA shows that seizures of illicit ketamine in the U.S. have risen from 55 seizures in 2017 to 247 in 2022, a 350% increase. Because much of its was seized in powder form, researchers are concerned black market ketamine could easily be adulterated with illicit fentanyl.

My Life Is on the Line Due to Rx Opioid Shortages

By Christine Kucera, Guest Columnist

On May 24, I had my regularly scheduled pain management appointment. The prescription for my normal regimen of 10mg oxycodone was sent electronically to my local CVS pharmacy. About an hour later, I received a text from CVS saying they received the prescription from my doctor.

I followed up later through their automated system. That is the moment of shocking revelation when I learned that my prescription was not going to be filled on time, and that it may not be ready until a week after my fill date.

Utterly panicked, heart racing, thinking and speaking a mile a minute, I contacted the pharmacy. They confirmed they were out of 10mg oxycodone tablets.

“What am I supposed to do?” I asked. A woman who I don’t know replied that I should try contacting other pharmacies.

Really? I can’t do that. Pharmacies won’t tell me, the patient, if they have a supply of a controlled substance. So she looked it up and said it looks like “X” pharmacy has it and that I should have my doctor send the prescription there. Unfortunately, by the time my provider received the message, it was too late.

I made multiple calls to another pharmacy and they were extremely rude. I called my pharmacy again. This time I spoke with a pharmacist that knew me. He was very understanding, as we discussed what to do next.

CHRISTINE KUCERA

We came up with a plan. He said to have my doctor send him a prescription for 5mg oxycodone. I immediately emailed my provider about the shortage and asked him to send a new prescription for 5mg, since they were out of 10mg tablets.

It was a very long night and I was extremely anxious waiting for a reply from my provider. As a long-term opioid patient of 30 years with intractable pain, I’ve been through the unimaginable, especially after the CDC published its first opioid guideline. Since 2016, I’ve been force tapered to suboptimal treatment levels, denied pain medication during multiple hospitalizations, and told to take Tylenol.

A surgeon even used prescription fentanyl on me during an interventional procedure after being told it doesn’t work on me – leaving me awake and screaming during the procedure. That’s just to name a few examples. Believe me, there are many more.

My thoughts are racing out of control. I can’t do this anymore. I can’t live life with unrelenting, unmanaged pain all day, every day. I’m barely holding on now, trying hard not give up hope. It’s not easy living in a body that’s under assault from an invisible invader, leaving my entire body riddled with rare diseases, along with severe bone, nerve, connective tissue and organ pain.

As a person with severe medically induced PTSD, I can fully recall all of the previous times I was forced off my managed regime of opiate medication. This time it’s going to be at the hands of the DEA, which has intentionally created shortages of oxycodone.

Next day arrives, a new prescription for 5mg is sent and I sigh with relief. It was short lived. Another pharmacist said my insurance company won’t cover the 5mg substitute without prior authorization. Completely losing control of my emotions, I asked why do I need another prior authorization?  My daily limit of 90 morphine milligram equivalents (MME) didn’t change, just the dose of the tablets

“It’s because of daily quantity limits,” the pharmacist replied.

Are you freaking serious?  I’m out of oxycodone as of today and you’re saying I can’t have 2 weeks of a substitute because there is no supply anywhere of 10mg and my insurance has quantity limits on 5mg doses?  I was angry and upset. This is so wrong! What am I supposed to do?

To that, the pharmacist says, “You can pay out of pocket.”

I didn’t have a choice, although I knew what happens from paying out of pocket with cash and sending prescriptions to new pharmacies. Those are red flags for prescription drug monitoring programs (PDMPs).

What’s next CDC and DEA? You’ve fabricated the great Opioid Lie and created policies that affect all pain care in all settings. Created new burdens for disabled and chronically ill patients. Created an opioid guideline that doesn’t allow for individualized treatment and places limits on prescriptions. You’ve shackled doctors with no options but to provide inadequate pain care or abandon patients altogether.

Now patients and their providers are having to deal with DEA created shortages of essential medicines. This has got to stop! Pain patients have never been the driver behind the overdose crisis. Anti-opioid prohibition policies are harming, torturing and killing U.S. citizens.

What do I do? There are no protections or even a set of procedures in place to assist patients and providers when there are shortages of controlled substances. It really is a nightmare situation. I feel helpless. The shortage is not my fault, the restrictions have gone too far, and my life is on the line.

Christine Kucera lives with psoriatic arthritis, spondyloarthropy, spondylitis, polyarthritis, sacroiliitis, degenerative joint disease, dermatomyositis, mixed connective tissue disease, spinal radiculopathy, hypoparathyroidism, rare endocrine tumors, psoriasis, endometriosis stage IV, pelvic adhesive disease, and other painful conditions. 

Prior to becoming disabled, Christine was a healthcare research systems developer and analyst for federally funded CMS, AHRQ, and NIH grants and programs. 

Do you have a “My Story” to share? Pain News Network invites other readers to share their stories about living with pain and treating it. We are particularly interested in your experiences dealing with current drug shortages. Send your stories to editor@painnewsnetwork.org.

12 Most Common Symptoms of Long Covid

By Pat Anson, PNN Editor

Since the first cases started appearing in 2020, medical experts have been baffled by Long Covid, a poorly understood disorder that causes chronic fatigue, insomnia, brain fog and dozens of other symptoms long after the initial infection with COVID-19.

The symptoms vary so much from person to person that identifying the cause is difficult. Is it Long Covid? Fibromyalgia? Chronic fatigue syndrome? Lyme disease? Or just a bad case of the flu?   

A new study led by the National Institutes of Health's RECOVER Initiative has identified the 12 most common symptoms of Long Covid, with the goal of creating a working definition of the condition to help make it easier to diagnose and treat.

"This study is an important step toward defining Long Covid beyond any one individual symptom," said lead author Leora Horwitz, MD, director of the Center for Healthcare Innovation and Delivery Science at NYU Langone Health. "This definition — which may evolve over time — will serve as a critical foundation for scientific discovery and treatment design."

Horwitz and her colleagues studied survey data from 9,764 adult volunteers from across the country. Nearly 90% had been infected with Covid. Some made complete recoveries, while others had symptoms of Long Covid – known technically as postacute sequelae of SARS-CoV-2 infection (PASC). About 23% of participants with a prior Covid infection met the working definition for Long Covid.

The study findings, published in JAMA, examined 37 symptoms across multiple body areas and organs. Researchers then applied statistical analysis to identify the 12 symptoms that someone with Long Covid is most likely to have: post-exertional malaise, fatigue, brain fog, dizziness, gastrointestinal symptoms, heart palpitations, issues with sexual desire, loss of smell or taste, thirst, chronic cough, chest pain, and abnormal movements.

By assigning points to each of the 12 symptoms, researchers gave each participant a PASC score based on their combination of symptoms. Some symptoms appeared at higher rates than others, with malaise and fatigue being the most prominent, occurring in nearly 90% of cases.

Frequency of Long Covid Symptoms

SOURCE: JAMA

"Now that we're able to identify people with Long Covid, we can begin doing more in-depth studies to understand the mechanisms at play," said coauthor Andrea Foulkes, ScD, Principal Investigator of the RECOVER Data Resource Core. "These findings set the stage for identifying effective treatment strategies for people with Long Covid — understanding the biological underpinnings is going to be critical to that endeavor."

The researchers found that Long Covid was more common and severe in participants who were infected before the Omicron strain emerged in late 2021. People who were unvaccinated and those with multiple Covid infections were also more likely to have severe symptoms.

Researchers identified four subgroups of patients with different clusters of symptoms. Some clusters spanned multiple organs, such as the heart, lung and brain, suggesting that a body-wide reaction to the virus may occur in some people with Long Covid.

As of May 2023, more than 100 million Americans have been infected with COVID-19, with experts estimating that about 6 percent of those infected with the virus continue to experience Long Covid symptoms.

Drug Distributor Vows to Fight DEA

By Pat Anson, PNN Editor

The fourth-largest drug distributor in the U.S. is vowing to fight efforts by the Drug Enforcement Administration to strip it of its license to sell opioids and other controlled substances to pharmacies, hospitals and health systems in 27 states.

Such a move by the DEA, if carried out, would not only put Morris & Dickson out of business but could exacerbate already tight supplies of pain medication and drugs used to treat cancer and attention deficit disorder (ADHD). The company said it would “vigorously appeal” the license revocation and seek a stay in federal court.

“We strongly believe any attempt to revoke our registration would be unwarranted and unjustified. Most importantly, any decision the DEA makes will not disrupt our operations. Business will continue as usual, and orders will continue to go out on time,” the Louisiana-based company said in a statement on its website.

The DEA announced Friday that it would revoke Morris & Dickson’s license, but allowed 90 days before the order takes effect. The action stems from a DEA investigation that identified thousands of suspiciously large orders for oxycodone and hydrocodone that the company sold to independent pharmacies in Louisiana from 2014 to 2018. In some cases, according to the DEA, the pharmacies were allowed to purchase six times the amount of opioids that they would normally order.

The DEA suspended Morris & Dickson’s license in 2018, but then delayed making a final decision on revoking it, which allowed the company to continue to operate. That five year delay came to a sudden end this week, after the Associated Press reported that the DEA failed to stop the company from “shipping highly addictive painkillers,” even after a judge recommended that its license be revoked for its “cavalier disregard” of the suspicious orders.

Further complicating the case is that a top DEA official retired from the agency in 2017 and went to work for Morris & Dickson, leading efforts at the company to improve the way it identifies and reports suspicious orders. Louis Milione “unretired” in 2021 and went back to work at the DEA as principal deputy administrator.    

Morris & Dickson spent millions of dollars improving its compliance system, but that was not enough for DEA Administrator Ann Milgram, who has come under increasing fire for her personnel decisions at the agency.

“Respondent (Morris & Dickson) has not adequately convinced the Agency that it can be entrusted with a registration — its acceptance of responsibility did not prove that it or its principals understand the full extent of their wrongdoing, the effect that it had on the Agency and the American public, and the potential harm that it caused. It was Respondent's burden to prove that it could be entrusted to protect the public interest in maintaining a DEA registration — and it has failed to do so,” Milgram said in her 68-page order.

Milgram said she would deny any application by Morris & Dickson to renew or modify its registration, and said her order would become final on August 28, 2023.

The company, however, said it would continue its “ongoing discussion” with the DEA to keep its license.

“Morris & Dickson is grateful to the DEA Administrator for delaying the effective date of the Order to allow time to settle these old issues, which has been our goal since this started years ago,” the company said. “We remain confident we can achieve an outcome that safeguards the supply chain for all of our healthcare partners and the communities they serve.”

That supply chain has been severely strained in recent years, not only by the pandemic, but by DEA actions that reduced the supply of opioids and other controlled substances.

In March, the American Society of Health-System Pharmacists added oxycodone to its list of drug shortages, after generic drug makers Amneal, Camber and Rhodes Pharmaceuticals reported they were running out of some doses of oxycodone tablets.

This month Teva Pharmaceutical said it would discontinue production of immediate release oxycodone and scale back its generic drug business to focus on more profitable medications.

The nation’s three largest drug distributors – McKesson, AmerisourceBergen and Cardinal Health — have already imposed strict limits on the amount of opioids and other controlled substances they sell as part of a $21 billion opioid litigation settlement. Whether they would be able to take on additional customers and supply them with essential medications that Morris & Dickson now provides is an open question.

“It’s hard to say what the overall impact would be. I don’t know how many pharmacies or hospitals are only serviced by Morris & Dickson,” says Erin Fox, PharmD, Senior Pharmacy Director at University of Utah Health, who has been tracking drug shortages for over 20 years. “They would have to establish contracts with another wholesaler. If pharmacies and hospitals have a secondary wholesaler, then they should be able to access opioids to dispense for patients.”