Epstein-Barr Virus Linked to Autoimmune Conditions

By Dr. Forest Tennant, PNN Columnist 

The Epstein-Barr virus (EBV) is a herpes virus that normally resides after infection as an organism in the epithelial tissues of the throat and lymphocytes. Most humans carry the virus and blood tests will often show low levels of EBV antibodies.  

Recent research has determined that in some people, for unknown reasons, the virus will reactivate and/or produce antibodies that carry toxic elements to tissues in the body such as the spinal cord. EBV infected lymphocytes can then cross the blood brain barrier and enter the brain, spinal cord and spinal fluid.  

This situation is now referred to as “EBV autoimmunity” and is reported by multiple medical institutions and researchers to be a major, causative factor in multiple sclerosis, systemic lupus, rheumatoid arthritis, and about 2% of the world’s cancer cases.  

Autoimmunity and Arachnoiditis 

Adhesive Arachnoiditis (AA) has long been known to be an inflammatory disease in which cauda equina nerve roots become adhered by adhesions to the arachnoid lining of the spinal canal. We have also long suspected that autoimmunity was a factor in AA, but until now there has been no compelling reason for this belief. 

In our review of over 800 confirmed cases of AA by magnetic resonance imaging (MRI), along with medical history and symptoms, a single fact emerged. Almost all cases had multiple herniated or protruding intervertebral discs prior to the development of AA. These discs were often in both the cervical and lumbar-sacral regions of the spine.  

Epidural injections, spinal taps or surgery often appeared to accelerate the development of AA. But further research revealed that most persons with MRI-documented AA had other medical conditions known to be common in persons with autoimmune disease. These included: burning mouth or feet, small fiber neuropathies, fibromyalgia, carpal tunnel, Hashimoto’s thyroiditis, Sjogren’s (dry eyes), Raynaud’s, irritable bowel, migraine, temporal mandibular joint pain (TMJ), chronic fatigue, arthritis, Tarlov cysts, mast cell conditions, and POTS. Persons with a genetic connective tissue disease of the Ehlers-Danlos Syndrome type were also significantly affected.  

From this we concluded that AA is usually a late-stage component of a multisystem, autoimmune, inflammatory disease. 

Between our realization that AA is associated with multiple medical conditions and the discovery that EBV causes significant autoimmunity, we began EBV testing in persons with MRI-documented AA. Essentially every case showed very high (sometimes above laboratory testing ability) antibody levels. Some showed evidence of EBV reactivation. Another finding has been that some persons with AA have high levels of cytomegalovirus, other strains of herpes, and/or Lyme. 

EBV is now known to cause a multitude of autoimmune conditions. Our studies indicate that AA is a late-stage development of an autoimmune disorder at least partially caused by EBV. This discovery leaves us little option but to recommend that each person with AA determines if they have multiple autoimmune manifestations including herniated discs and, if so, seek EBV antibody testing and become knowledgeable about control measures. 

Forest Tennant, MD, DrPH, is retired from clinical practice but continues his research on the treatment of intractable pain and arachnoiditis. This column is adapted from an updated bulletin recently issued by the Arachnoiditis Research and Education Project. Readers interested in subscribing to the bulletins should click here.

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

Fibromyalgia: Often Ignored and Poorly Treated

By Victoria Reed, PNN Columnist

Up until about 10 years ago, I had never heard of fibromyalgia. But during a routine medical visit, my doctor recognized symptoms that I described as possibly being signs of fibromyalgia. After an in-depth exam and other testing, a diagnosis of fibromyalgia was made.

Fibromyalgia is a complex disorder which causes widespread musculoskeletal pain, fatigue, sleep and memory issues. Symptoms can begin after a traumatic injury, surgery or infection. It sometimes takes many years to receive a diagnosis, and there is currently no cure.

People like me with autoimmune disorders, such as rheumatoid arthritis or lupus, often suffer from fibromyalgia. It is more common in women than men. The disorder can be accompanied by headaches, irritable bowel syndrome, anxiety and depression. Many fibromyalgia patients also complain of “fibro fog,” which impairs the ability to focus, pay attention and concentrate on mental tasks.

Fibromyalgia seems to run in families. I have multiple family members with the condition, spanning at least three generations. My mother had symptoms of fibromyalgia, but unfortunately never received a diagnosis.

Many experts agree that the key mechanism behind fibromyalgia is central sensitization, which causes the brain and spinal cord to become hypersensitive to pain signals. Pain will be amplified and linger well beyond the initial injury. The hypersensitivity can also affect other senses, leading to discomfort with strong scents or chemicals, bright lights and sounds. Being in loud, crowded spaces can create an overwhelming experience for fibromyalgia sufferers. 

Unfortunately, fibromyalgia is still a somewhat controversial diagnosis, because it is not yet fully understood and its symptoms can overlap with many other conditions. Some people even say that it’s a “garbage can” diagnosis that’s only given when no other one can be made. Many old school doctors believe that fibromyalgia is not a real condition, which is why it can often take years to receive a proper diagnosis.

However, recent research has discovered that there are differences in the brains of fibromyalgia patients. One important discovery is that of neuro-inflammation, which, simply put, is inflammation in certain regions of the brain. This research, documented by PET scans, does confirm inflammatory mechanisms in the brains of fibromyalgia patients and is a major step forward in trying to understand and treat it. It also helps to validate the existence of the condition itself.  

People with fibromyalgia are sometimes not taken seriously by their own doctors and denied appropriate pain management. Many are also denied disability payments as well. I know from experience that the condition can be terribly painful, with deep muscle aches and sore tender spots all over the body.

I have not had success with any of the traditionally prescribed drugs, such as Lyrica (pregabalin), an anticonvulsant that’s also used to treat nerve pain and seizures. While I’ve had some success with a high-quality CBD oil and various CBD creams, it is my prescribed pain medication, in combination with acetaminophen, that gives me the most pain relief.

Unfortunately, some fibromyalgia patients encounter roadblocks in finding a physician who is willing to prescribe pain medication if the only condition they have is fibromyalgia. This definitely needs to change! Fibromyalgia patients are worthy of treatment whether they have other pain conditions or not. The current anti-opioid climate continues to cause patients to suffer needlessly.

If you feel that you may be suffering from fibromyalgia, don’t be afraid to push, push and push for a diagnosis! If your doctor is not willing to help you, look for another doctor and don’t stop until you find one that takes your symptoms seriously. Research all you can on the condition and learn what you can do to help yourself.

Even though it might be difficult to exercise due to the fatigue that fibromyalgia causes, start by adding a little walking to your daily routine, even if it’s just 5 or 10 minutes. Exercise is good for your overall health and well-being, and it can help improve your mood. Being completely sedentary will only make things worse.

Regular massage is sometimes prescribed as well. If you can’t afford a professional massage, you can get a prescription for a therapeutic/medical massage, which will be a little cheaper. You can also purchase one of those self-massage sticks that can be found at sporting goods stores. I have found these things to be helpful to manage my symptoms.

I also suggest joining an online support group. There are many, many people suffering from fibromyalgia, and in these groups you can connect with people around the world, make some new friends, and learn about treatments that work for others.

Living with fibromyalgia is not easy, but it doesn’t have to be a hopeless situation either. If more doctors would take the condition seriously, make a timely diagnosis and provide appropriate treatment, perhaps there would be less suffering for those of us with fibromyalgia.

Victoria Reed lives in northeast Ohio. She suffers from endometriosis, fibromyalgia, degenerative disc disease and rheumatoid arthritis. 

UK Warns Pregnant Women About Taking Pregabalin

By Pat Anson, PNN Editor

Health officials in the UK are warning women of childbearing age that pregabalin (Lyrica), a drug commonly prescribed for pain, anxiety and epilepsy, raises the risk of major birth defects.

A recent study in four Nordic countries of over 2,700 pregnancies found that 5.6% of babies born to women who took pregabalin in the first three months of pregnancy had birth abnormalities. That compares to 4.1% of babies whose mothers did not use pregabalin.  

“The study showed that taking pregabalin during early pregnancy was associated with a slightly increased chance of having a baby who is born with a physical birth abnormality. It is important to note that this study could not show that pregabalin was the cause of the physical birth abnormalities,” the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) said in a new safety alert.

The birth defects associated with pregabalin primarily involved the nervous system, eyes, face, urinary system and genitals. The MHRA – which regulates drugs in the UK – cautioned pregnant women not to stop taking pregabalin without talking to a doctor first.

“If you think you may be pregnant and are currently taking pregabalin, you should set up an appointment with your GP, specialist or nurse at your earliest opportunity, to discuss any concerns you may have. However, do continue to take pregabalin as prescribed until you can speak to them,” the MHRA alert said. “Untreated epilepsy, pain, or anxiety could be harmful to you and your unborn baby. It is important that you talk to your healthcare professional before stopping pregabalin or making any changes to your usual medicines.”

An international study in 2016 also linked pregabalin to birth defects. Women taking pregabalin were found to be six times more likely to have a baby with a major birth defect, including abnormalities in the heart, central nervous system (CNS) and other organs.

Pregabalin Concerns

In recent years, pregabalin has come under increased scrutiny in the UK.  In 2021, the MHRA said pregabalin was associated with serious breathing problems in people over age 65 and in patients with compromised respiratory systems.

Doctors in Northern Ireland were also told last year not to prescribe pregabalin for neuropathic pain due to a “significant increase” in drug-related deaths involving the drug.

In 2019, pregabalin and gabapentin (Neurontin) were both rescheduled as Class C drugs in the UK due to a rising number of overdose deaths. Health experts said the medications cause “an elevated mood in users” and could have serious side effects when combined with other drugs.

Lyrica and Neurontin are two of Pfizer’s top selling drugs and generate billions of dollars in annual sales. They belong to a class of nerve medication called gabapentinoids that were originally developed to treat seizures, but are now widely prescribed as an alternative to opioid painkillers. A 2019 study found little evidence that gabapentinoids should be used to treat pain and said their effectiveness was often exaggerated by prescribing guidelines.

In the United States, where Lyrica is approved for fibromyalgia, neuropathic pain, seizures and postherpetic neuralgia, the FDA’s lengthy warning label states that “there are no adequate and well-controlled studies with Lyrica in pregnant women,” but at the same time cautions that “Lyrica may harm your unborn baby.”  

An earlier warning label said it was “not known if Lyrica will harm your unborn baby.”

Strict Low-Calorie Diet Reduces Fibromyalgia Symptoms

By Pat Anson, PNN Editor

Fibromyalgia patients with obesity experienced a significant reduction in pain and other symptoms after three weeks on a strict low-calorie diet, according to a new study that suggests limiting calories – not just weight loss – can have an analgesic effect.

Researchers enrolled nearly 200 patients diagnosed with fibromyalgia who were participating in a weight management program at the University of Michigan Health System. Participants had an average body mass index (BMI) of 41, which is considered severe obesity.

For 12 weeks, they were put on a very low energy diet (VLED) that limits bread, rice, potatoes and other foods that are high in carbohydrates. VLED is designed to shift the body away from using glucose in sweet or starchy foods to burning its own body fat for energy. Study participants were limited to just 800 calories a day, less than half the amount recommended for adult women and only a third of the amount recommended for men.

After just three weeks on the restricted diet, nearly three out of four participants (72%) experienced symptom reductions of 30% or more, regardless of the amount of weight lost. Patients who showed little or no improvement had a higher BMI at the start of the study and were more likely to have had a diagnosis of depression.

“Our results show, for the first time, that individuals following aggressive calorie restriction, ie, a VLED, had rapid and significant improvements in pain distribution and common pain-related comorbid symptoms and, importantly, prior to the achievement of significant weight loss,” researchers reported in the journal ACR Open Rheumatology.

“Furthermore, improvement at week 3 was strongly associated with improvement over the entire 12-week course of VLED, suggesting that patients who respond are likely to show these effects early in the process. These findings provide preliminary support for the hypothesis that calorie restriction, per se, can reduce pain and comorbid symptoms in individuals with obesity.”

Fibromyalgia is a poorly understood disorder characterized by widespread body pain, fatigue, poor sleep and depression. The FDA has approved three drugs to treat fibromyalgia -- duloxetine (Cymbalta), milnacipran (Savella) and pregabalin (Lyrica) -- but many patients say the drugs are ineffective and often have side effects.  

Previous studies have suggested that weight loss can help lower pain levels, but the improvement was thought to be caused by reduced stress on knees, hips and lower back – parts of the body that are weight-bearing.  

The new study suggests that a strict diet alone can significantly reduce fibromyalgia pain without major weight loss, but researchers caution that more studies are needed to fully understand the biological processes at work.

“The implications of this study suggest an early association between caloric restriction, through a VLED, and fibromyalgia symptoms. Although a larger study with a control group would be the next step in investigating this association, this provides important information for clinicians who counsel patients on alternatives to pharmacologic treatments for pain and other somatic symptoms,” researchers concluded.     

Many previous studies have shown that a low calorie diet can help reduce pain levels. A 2018 study at the University of Michigan found that obese patients on a low-calorie liquid diet for 12 weeks not only had lower pain levels in their knees and hips, but also in unexpected areas such as the abdomen, arm, chest and jaw. Study participants who lost 10% of their weight also reported better mental health, improved cognition and more energy.

Misogyny in Medicine Harms Fibromyalgia Patients

By Dr. Denise Phan, Guest Columnist

Anyone who has practiced medicine or been involved in women's health in the past 50 years has encountered fibromyalgia in one form or another. Many of us have seen the fibromyalgia pendulum swing from under-recognition to over-diagnosed, and back to under-diagnosed again.

Although the course of fibromyalgia mirrors our society's recognition and treatment of pain in general, this particular disorder is also handicapped by its association with women. Since women were not part of the medical and research establishment until recently, diseases that affect women exclusively or predominantly have often been ignored or downplayed. 

Admittedly, fibromyalgia is not an easy diagnosis to make and has no reliable treatments. It is also not progressive, does not cause permanent muscle or joint damage, and does not directly cause early death. Until recently, there were no easy blood markers for fibromyalgia as with other rheumatologic diseases. No x-rays or MRI findings can help diagnose it. 

But the main problem with fibromyalgia was that the vast majority of patients who present with this syndrome of widespread pain and tender points are women.

Thus, it was easier for the arrogant and sexist wing of medicine to relegate fibromyalgia to the "histrionic" or "psychogenic" disorders that predominantly affect women. 

DR. DENISE PHAN

Other examples of severe disabling painful conditions that affect women more than men are endometriosis, pelvic pain, polymyalgia rheumatica, migraine, lupus, scleroderma, and trigeminal neuralgia. Some of these disorders are just now being recognized, researched and beginning to get treated. 

Though the term fibromyalgia was first coined in the 1970s, the disease can be traced back thousands of years to biblical times. When I was going through medical school and residency training in the 1980s, many of my attending physicians refused to recognize fibromyalgia as a "real" disorder and often did not offer any treatment for it. 

To some degree, this was due to our poor understanding of how the nervous system affects musculoskeletal tissue. But in the vast majority of cases, the refusal to acknowledge fibromyalgia stemmed from the undercurrent of misogyny that permeates medicine even today. 

Learning How to Treat Fibromyalgia

There were others in the medical community who recognized fibromyalgia and taught me what it was, how to diagnose it, and how to treat it -- despite our very limited, almost non-existent treatment options at the time.

In the 1990s, when I started my private practice in California’s San Fernando Valley, my practical education of fibromyalgia was furthered by the multiple women who presented in my office with this puzzling, intractable disease. Since there were no FDA-approved treatments yet, we would try every and any off-label treatment possible to see if we can get any long-term or even short-term relief of symptoms. 

There were the traditional trials of NSAIDs, tricyclics like amitriptyline, trazodone, SSRI's, low dose opioids, muscle relaxants, warm water physical therapy, trigger point injections; and then the non-traditional treatments like guaifenesin, anti-inflammatory diets, acupuncture, yoga, tai-chi, sauna, infrared therapy, cannabis, low dose naltrexone and moving to a warm, dry climate. 

Although none of these treatments are highly effective; when they did work it was a tremendous relief to restore function to these long-suffering patients. Despite this, I would still occasionally learn of suicide threats and attempts by fibromyalgia patients who did not respond to any of these treatments. 

These patients pushed me and other doctors to treat pain seriously; so that it does not become a cause of other morbid pathologies such as depression, fibro fog, cervicogenic headache, irritable bowel, overactive bladder and chronic fatigue. It also emboldened us to use stronger opioids, if necessary, to control chronic pain. This coincided with the release of longer-acting opioids like MS Contin, fentanyl patches and OxyContin. 

As the recognition of fibromyalgia went mainstream in the 2000s, so did the push to control pain more aggressively with higher doses of opiates. Laws were passed and guidelines were published, urging physicians to treat pain seriously. Physicians were taught, in one seminar after the other, that longer-acting opioids would control pain throughout the day with less need for pill-popping. This would provide more stable blood levels and less euphoria, making opioids less habit-forming and minimize addiction potential. 

In the late 2000s, Lyrica was the first medication specifically approved for the treatment of fibromyalgia, followed in quick succession by Savella and Cymbalta. Fibromyalgia patients benefited from the increased recognition and treatment of their disorder and the aggressive approach to pain control. 

Many of my patients who didn't respond to off-label treatments achieved remission with the new FDA-approved meds. Some who didn't were eventually stabilized on higher doses of hydrocodone, oxycodone, Dilaudid, methadone, buprenorphine, morphine or fentanyl. Some of the more severe cases were able to get off oral meds and restore normal daily function after we implanted subcutaneous pain medicine pumps. 

A New Betrayal

Then in the early 2010s, reports of rising death tolls from opiate overdoses began coming in, often involving drug seekers who were crushing and snorting OxyContin tablets to get high. It was also recognized that patients on chronic opioids were at risk of accidental overdose.

In response, more cautious opioid prescribing guidelines came out from state medical boards and the CDC; followed by the DEA prosecuting pharmacies and pain management doctors. One pain clinic after another started closing down, their patients were often red-flagged and unable to find new doctors. Vast numbers of patients became collateral damage as the news media and legal profession fanned the flames of the war against opiates. 

For chronic pain patients in general, the lack of access to pain meds required them to make serious adjustments to their lifestyles, like not getting out of bed, not holding a job, and not taking care of their family. For many fibromyalgia patients, it was as if the doors to treatment were slammed shut. 

The latest betrayal for these patients is coming from the medical and academic community itself. I was horrified and shocked at my last pain management seminar when the young professor lecturing on the topic of fibromyalgia stated aloud the official current policy of the medical community is that there is no role for opioids in treating fibromyalgia. 

When asked what we should do for patients who have failed all the recommended treatments, FDA-approved and otherwise, he could only recommend yoga. That was when I realized that misogyny was back in style. The medical community has been cowed by “opiate hunters” into toeing the line and spouting what is essentially a ludicrous theory: the idea that we should not use pain medicine in the treatment of chronic pain. 

This is what is being taught today in medical schools all over the country. The next generation of physicians is being trained to think that it's okay to leave people in chronic pain day after day, when there are good medicines available that, when used judiciously, may be able to restore life and function to an incapacitated patient. 

Obviously, there is the risk of serious side effects from opioids, just as there are for any powerful medications. But that is what we are trained to do, to take into account these side effects for each individual patient, to evaluate the risks versus benefits of each treatment, and to monitor them as best we can. That is what my Hippocratic Oath tells me to do. 

Now, if only we can get through to the other less misogynistic side of the medical community. The ones with enough courage to speak truth to power. There are some of them in medical schools and ivory towers everywhere, who can recognize injustice and who will speak common sense to our future doctors. 

Dr. Denise Phan is an Internal Medicine physician in Los Angeles. She works in private practice in the San Fernando Valley and is on staff at Valley Presbyterian Hospital. Dr. Phan is active in the annual missions of the mobile health units of the Social Assistance Program for Vietnam and the International Humanitarian Mission.

A Third of Long Haulers Have ‘FibroCOVID’

By Pat Anson, PNN Editor

Nearly a third of patients with long-haul covid have symptoms strikingly similar to fibromyalgia, according to a new study by Italian researchers who say being male and obese are strong risk factors for developing “FibroCOVID.”  

“In the light of the overwhelming numbers of the SARS-CoV-2 pandemic, it is reasonable to forecast that rheumatologists will face up with a sharp rise of cases of a new entity that we defined (as) ‘FibroCOVID’ to underline potential peculiarities and differences,” wrote lead author Francesco Ursini, MD, an Associate Professor of Rheumatology at the University of Bologna.

The study findings, published online in RMD Open: Rheumatic & Musculoskeletal Diseases, are based on a survey of over 600 patients with post-acute COVID-19 – also known as "long COVID."

Nearly 31% of the long-haulers had musculoskeletal pain, fatigue, cognitive impairment and sleep disturbances – classic symptoms of fibromyalgia, as defined by the American College of Rheumatology.

Unlike traditional fibromyalgia, which primarily affects women, a higher percentage of men (43%) had symptoms of FibroCOVID. They were also more likely to be obese, have high blood pressure, and a severe COVID-19 infection.

“Globally, respondents with FM (fibromyalgia) exhibited features suggestive of a more serious form of COVID-19, including a higher rate of hospitalisation and more frequent treatment with supplemental oxygen,” Ursini and his colleagues reported. “Taken together, our data suggest a speculative mechanism in which obesity and male gender synergistically affect the severity of COVID-19 that, in turn, may rebound on the risk of developing post-COVID-19 FM syndrome and determine its severity.”

The long-term effects of a COVID-19 infection are currently unknown. While some patients have minor symptoms and recover quickly, about a third will develop long COVID and have symptoms that persist for several months after the initial infection.  

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

Vaccines Cut Risk of Long Covid

Being fully vaccinated against COVID-19 cuts the risk of developing long covid in half, according to a new UK study. Researchers at King’s College London looked at health 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.

“We found that the odds of having symptoms for 28 days or more after post-vaccination infection were approximately halved by having two vaccine doses. This result suggests that the risk of long COVID is reduced in individuals who have received double vaccination, when additionally considering the already documented reduced risk of infection overall,” researchers reported in the journal The Lancet Infectious Diseases.

“Almost all individual symptoms of COVID-19 were less common in vaccinated versus unvaccinated participants, and more people in the vaccinated than in the unvaccinated groups were completely asymptomatic.”

Fully vaccinated.people aged 60 or older were more likely to have no symptoms of a breakthrough infection, according to researchers.

Fibromyalgia Patients Needed for Online Therapy Study

By Pat Anson, PNN Editor

A digital therapeutics company is looking for volunteers to participate in a clinical trial to see if smartphone-based therapy can improve symptoms of fibromyalgia.

Swing Therapeutics recently announced that its acceptance and commitment therapy program (ACT), a form of cognitive behavioral therapy (CBT), has received Breakthrough Device Designation from the Food and Drug Administration. CBT is a form of psychotherapy, in which patients are encouraged to reduce unhelpful thinking and behavior.

“Currently, most people living with chronic pain conditions like fibromyalgia are offered medications and some suggestions for modifying their lifestyle. Behavioral therapies have evidence supporting their effectiveness for pain management, but are not widely available or easily accessed by the average individual,” said David Williams, PhD, Associate Director of Chronic Pain and Fatigue Research Center at the University of Michigan, who is an advisor to Swing Therapeutics.

The company says a pilot study of its online therapy program has shown promise in managing fibromyalgia, a poorly understood disorder characterized by widespread body pain, fatigue, poor sleep and depression. The self-guided daily program includes interactive lessons and exercises designed to help fibromyalgia sufferers understand, accept and manage their symptoms. The core program lasts 12 weeks, followed by a maintenance phase for extended use.

Swing is looking for 500 participants in the U.S. who are at least 22 years of age and have a diagnosis of fibromyalgia. The digital therapy program can be conducted at home, with no in-person medical visits or medications required.  Participants will receive compensation after completing surveys at the end of the 12-week program. Click here to learn more about the study.

“Our team is committed to creating valuable digital therapies and demonstrating strong clinical evidence to support their use. The results of our initial studies are encouraging, and with the support of the FDA, we look forward to optimizing the product as we advance through our pivotal trial,” said Mike Rosenbluth, PhD, founder and CEO of Swing Therapeutics.

The FDA has approved only three drugs to treat fibromyalgia: the antidepressants duloxetine (Cymbalta) and milnacipran (Savella), and the anti-seizure medication pregabalin (Lyrica). Many patients say the drugs are ineffective and have side effects. A recent analysis found little evidence to support the long-term use of any medication or therapy to treat fibromyalgia.

Widespread Pain Raises Risk of Dementia and Stroke

By Pat Anson, PNN Editor

Widespread body pain caused by fibromyalgia and other chronic pain conditions raises the risk of stroke and dementia, including Alzheimer’s disease, according to a new study.

Researchers looked at health data for nearly 2,500 second generation participants in the long-running, community-based Framingham Heart Study. Participants in the “offspring” phase of the study were given a comprehensive check-up that included a physical exam, lab tests and detailed pain assessment when they enrolled in the early 1990’s. They were then reassessed every four years for signs of cognitive decline, dementia or stroke.

Over the next two decades, 188 of the participants were diagnosed with some form of dementia and 139 had a stroke.

While the number of cases was small, researchers found an association between pain and cognitive decline. Participants with widespread pain were 43% more likely to have some type of dementia, 47% more likely to have Alzheimer’s disease, and 29% more likely to have a stroke compared to those without widespread pain (WSP). 

“These findings provide convincing evidence that WSP may be a risk factor for all-cause dementia, AD dementia (Alzheimer’s), and stroke,” researchers concluded. “While it is known that chronic pain or persistent pain without detailed classification is associated with poorer cognitive performance in cross-sectional or cohort studies, our study was based on much more accurate assessments for pain at a longitudinal population level. The specific presence of WSP… has long-term implications for dementia and AD.”

The researchers said there were three possible explanations for the link between pain and cognitive decline. First are lifestyle factors associated with pain, such as reduced physical activity, poor diet, alcohol and weight gain. Second is that stress caused by widespread pain may impair cognitive function; and third is that WSP may be a “preclinical phase” of dementia and AD.

Previous studies have also linked chronic pain to dementia. A large 2017 study found that older people with chronic pain experience faster declines in memory and are more likely to develop dementia. A more recent study suggests that people with chronic pain are at higher risk of memory loss and cognitive decline if they have lower levels of education, income and access to healthcare.

Antidepressants, anti-psychotics, antihistamines and other common medications may also cause confusion and disorientation that is mistaken for dementia, especially in older adults. When patients are taken off the drugs, their cognitive function may improve.  

Previous studies have also linked widespread pain to cancer, peripheral arterial disease, cardiovascular disease and increased mortality.

Study of Fibromyalgia Drug Continues Despite Disappointing Results

By Pat Anson, PNN Editor

New Jersey-based Tonix Pharmaceuticals says it will proceed with a Phase 3 study of a drug to treat fibromyalgia, despite disappointing results that caused the company to stop enrolling new patients.

Based on an interim analysis of the first 337 participants enrolled in the RALLY study, an independent data monitoring committee found that TNX-102 SL was unlikely to demonstrate a statistically significant improvement in pain compared to placebo. No issues were reported on the safety of the drug.

The finding of the monitoring committee is somewhat surprising, because Tonix recently reported results from another Phase 3 study, which found that TNX-102 SL significantly reduced pain compared to placebo and also improved sleep, fatigue and function in fibromyalgia patients.

“We are surprised and disappointed that the interim analysis did not support continued enrollment in this Phase 3 RALLY study, especially considering the previous Phase 3 RELIEF study, which had a similar design and achieved statistical significance on the primary endpoint,” said Seth Lederman, MD, President and CEO of Tonix. “These results underscore the difficulty in managing and treating fibromyalgia.”

Lederman said the company would continue its Phase 3 trial with the patients who are already enrolled and report the results in the fourth quarter of 2021. It will then determine its next steps.

TNX-102 SL is a sublingual tablet formulation of cyclobenzaprine hydrochloride, a muscle relaxant and anti-depressant that’s being evaluated as a daily bedtime treatment for fibromyalgia. The goal is to see if TNX-102 SL helps fibromyalgia patients sleep better.  In addition to fibromyalgia, TNX-102 SL is also being considered as a treatment for post-traumatic stress disorder (PTSD), alcohol use disorder and agitation in Alzheimer’s disease.

Fibromyalgia is a poorly understood disorder characterized by widespread body pain, fatigue, poor sleep and depression. The National Institutes of Health estimates about 5 million Americans have fibromyalgia. Most people diagnosed with fibromyalgia are women, although men and children can also be affected.

The FDA has approved only three drugs to treat fibromyalgia; the antidepressants duloxetine (Cymbalta) and milnacipran (Savella), and the anti-seizure medication pregabalin (Lyrica). Many fibromyalgia patients say the drugs are ineffective and have unwelcome side effects. A recent analysis found little evidence to support the long-term use of any medication or therapy to treat fibromyalgia.

Can Psychedelics Be Used to Treat Fibromyalgia?

By Pat Anson, PNN Editor

A startup pharmaceutical company has announced plans for a clinical trial to see if a psychedelic compound may be useful in treating fibromyalgia.

California-based Tryp Therapeutics is partnering with scientists at the Chronic Pain & Fatigue Research Center at University of Michigan Medical School for the Phase 2a study, which would be the first to evaluate the effictiveness of psilocybin – the psychoactive compound in “magic mushrooms” -- in treating fibromyalgia.

"We are thrilled to collaborate with such forward-looking clinicians and scientists to develop additional treatment options for fibromyalgia," Jim Gilligan, PhD, Tryp’s President and Chief Science Officer said in a statement.

"The Chronic Pain & Fatigue Research Center at the University of Michigan brings incomparable experience with evaluating treatments for fibromyalgia and other chronic pain indications, and there is nothing more important to our collective team than creating therapies that will address the daily distress of these patients."

The study will evaluate the safety and efficacy of TRYP-8802, an oral formulation of synthetic psilocybin developed by Tryp. The treatment, which will also include psychotherapy, is designed to target pain through neuroplasticity, which alters and reorganizes neural networks in the brain.

Fibromyalgia is a poorly understood disorder characterized by widespread body pain, fatigue, poor sleep, anxiety and depression. Standard treatments for fibromyalgia, such as non-steroidal anti-inflammatory drugs (NSAIDs) and gabapentinoids (Lyrica, Neurontin), often prove to be ineffective or have unwelcome side effects.

"Existing treatment options for fibromyalgia are often ineffective and show significant side effects," said Daniel Clauw, MD, Director of the Chronic Pain & Fatigue Research Center.

Tryp plans to submit an Investigational New Drug application to the FDA for the Phase 2 trial in September. Phase 2 studies typically involve a few hundred people with a disease or condition, and are designed to test the safety and efficacy of a treatment.  A much larger Phase 3 study is usually required before the FDA will even consider approval.

Interest in using psychedelics to treat medical conditions has been growing in recent years, primarily as a way to treat depression, anxiety and other mental health issues. Preliminary research suggests that microdoses of LSD, psilocybin and other psychedelics may also be effective in treating pain.

Another pharmaceutical startup – Mind Medicine (MindMed) – recently announced plans to  investigate LSD as a treatment for cluster headache and an unnamed “common, often debilitating, chronic pain syndrome.”

Tryp Therapeutics is focused on developing psilocybin-based compounds for the treatment of diseases with unmet medical needs. The company recently announced a partnership with the University of Michigan to study synthetic psilocybin as a treatment for neuropsychiatric disorders. Tryp is also working with the University of Florida to investigate psilocybin as a treatment for eating disorders.

LSD, psilocybin and other psychedelics are classified as Schedule I controlled substances, meaning they have a high potential for abuse and currently have no accepted medical use in the United States.

Fibromyalgia Patients Substituting CBD for Pain Medication

By Pat Anson, PNN Editor

With opioid medication increasingly harder to obtain, many people with chronic pain are turning to cannabis-based products for pain relief.  A new survey of fibromyalgia patients suggests that cannabidiol (CBD) works well not only as an alternative to opioids, but for many other pain medications.

Researchers at Michigan Medicine surveyed 878 people with fibromyalgia who were currently using a CBD product and found that 72% of them had substituted CBD for a conventional pain medication.

Over half (59%) reduced or stopped taking non-steroidal anti-inflammatory drugs (NSAIDs), while 53% used CBD as a substitute for opioids, gabapentinoids (35%) or benzodiazepines (23%), an anti-anxiety medication that was once commonly prescribed for pain.

"I was not expecting that level of substitution," said Kevin Boehnke, PhD, a research investigator in the Department of Anesthesiology and the Chronic Pain and Fatigue Research Center at Michigan Medicine.

Fibromyalgia is a poorly understood disorder characterized by widespread body pain, fatigue, poor sleep, anxiety and depression. Standard treatments for fibromyalgia such as gabapentinoids often prove to be ineffective or have unwelcome side effects.

"Fibromyalgia is not easy to treat, often involving several medications with significant side effects and modest benefits," said Boehnke. "Further, many alternative therapies, like acupuncture and massage, are not covered by insurance."

CBD is one of the chemical compounds found in cannabis, but it doesn’t have the same intoxicating effect as tetrahydrocannabinol (THC), the psychoactive ingredient in marijuana.  Some cannabis products contain a combination of THC and CBD, while others just have CBD.

Survey participants who used CBD products containing THC were more likely to report symptom relief and to use them as substitutes for pain medication. This suggests that THC may enhance the therapeutic benefits of CBD.

A recent Israeli study found that people with fibromyalgia who took daily doses of cannabis oil rich in THC had significantly less pain and fatigue.

Another recent study in Israel found that cannabis products – both with and without THC – reduced pain and depression in fibromyalgia patients. Like the findings of the Michigan study, about one out of five patients either stopped taking or reduced their use of opioids and benzodiazepines.

"People are using CBD, substituting it for medication and doing so saying it’s less harmful and more effective,” said Boehnke. “If people can find the same relief without THC's side effects, CBD may represent a useful as a harm reduction strategy."

The Michigan Medicine study was recently published in The Journal of Pain.

The Trouble With Pain Treatment Guidelines

By Donna Gregory Burch

I'm trying to figure out why certain medical organizations think they know more about treating my chronic pain than my actual doctors. It seems every single one of these groups shares the same opinion: Opioids are bad. Antidepressants, exercise and meditation are good.

That's the takeaway from new treatment guidelines for fibromyalgia and other forms of “chronic primary pain” released by the European Pain Federation and the UK’s National Institute for Health and Care Excellence (NICE). Both sets of recommendations are on trend with the opioid prescribing guideline adopted by the U.S. Centers for Disease Control and Prevention (CDC) in 2016.

The European Pain Federation recommends against using opioids to treat fibromyalgia, low back pain, irritable bowel syndrome and other forms of chronic primary pain for which there is no known cause. Opioids can be used for certain types of “secondary” pain caused by surgery, trauma, disease or nerve damage, according to the federation, but only when other treatments such as exercise, meditation and non-opioid medications have failed.

The NICE guidelines are even stricter, advising physicians not to prescribe any kind of painkiller to those with fibromyalgia, chronic headache, chronic musculoskeletal pain and other chronic primary conditions. That includes non-opioid painkillers like paracetamol (acetaminophen), non-steroidal anti-inflammatory drugs (NSAIDs), gabapentinoids (gabapentin, pregabalin), corticosteroids (prednisone, prednisolone) and benzodiazepines (Valium, Xanax).

As someone who lives with fibromyalgia, chronic lower back pain and chronic daily headaches, I thank God that I don't live across the pond, as they say. Frankly, I'd probably throw myself off a bridge if my doctors adhered to either of these guidelines.

And no, I'm not being overdramatic. I'm sure I speak for many of the readers here at Pain News Network and my own website, Fed Up With Fatigue, when I express alarm over how authoritarian and inhumane these guidelines aimed at chronic pain patients are becoming.

Of course, things aren't much better on U.S. soil. Physicians here are still running scared due to the CDC's opioid guideline. It's becoming increasingly difficult to find doctors who will prescribe opioids or even accept a patient who is already on opioids. It matters little if the patient has been using them responsibly for years or even decades.

A ‘Little Bit of Life’ Gone

A couple of weeks ago, one of my readers shared that she used to be able to work and manage her home when her opioid dosage was at a certain level. But then the CDC decided to stick its nose into her personal health journey by recommending that general practitioners should not prescribe opioids to patients with fibromyalgia.

Her doctor saw those recommendations and cut her dosage. Now, she's basically homebound. The little bit of life that she had as a chronic pain patient is no longer.

How is this fair? Or humane?

It isn't.

And why is she being punished because a small number of opioid users were irresponsible and became addicted? That is not the fault of the millions of opioid users who do use them responsibly!

It's easy for “experts” and regulators to condemn opioids when they're not the ones in pain. And it's a slap in the face to have them tell me I should take ibuprofen for a migraine, or worse yet, to go take a walk.

Obviously, they haven't experienced the headaches that I have - one of which was so bad that I curled up in a ball on the sofa and whispered to my husband through tears, "I just want to die."

And yes, it really was that bad! To suggest that doing some deep breathing or talking with a counselor is going to help that level of pain is completely asinine.

Opioids and Fibromyalgia

But I think what pisses me off the most is that these government agencies and medical organizations constantly say over and over and over again that opioids don't work for fibromyalgia. There's no way they actually took the time to review the existing research, because if they had they would know that statement is based on opinion, not fact.

The truth is very few research trials have actually studied if opioids are an effective treatment for fibromyalgia. In 2016, I took a deep dive into the research on using opioids for fibromyalgia and was stunned by just how little data there really is.

In 2011 and 2013, there were a couple of large studies at McGill University in Montreal, Canada, involving around 300 fibromyalgia patients who were being treated with opioids. The researchers concluded "opioid-treated patients were more symptomatic and were more likely to be unemployed and to be receiving disability benefits."

The inference from that statement is that somehow the opioids increased the patients' symptoms when there's no way to know for sure if that's what really happened. It's entirely possible those patients were on opioids because their symptoms were more severe, which would also explain why those particular patients were more likely to be unemployed and on disability.

You'd think these researchers would remember a simple principle that many of us learned in college: Correlation doesn't equal causation.

Then, there have been at least three studies (2000, 2003 and 2011) that looked at the effectiveness of tramadol, a weaker synthetic opioid, at reducing fibromyalgia pain. All of these studies confirmed tramadol improved fibro-related pain.

A small Swedish study from 1995 found intravenous morphine did not improve fibromyalgia pain, and a 2003 study from the University of Cincinnati College of Medicine concluded opioids were not effective.

I might have missed a small trial here and there, but that's basically the gist of the research that has studied the use of opioids for fibromyalgia. Little has changed since I reviewed the research five years ago. There still haven't been any large trials testing the efficacy of opioids in fibro patients.

So looking at the scant research that's available, how can the people who develop these treatment guidelines honestly say opioids don't work for fibromyalgia patients? They can't.

As the saying goes, "absence of evidence is not evidence of absence." In other words, you can't say opioids don't work when you've never even taken the time to study whether opioids help fibromyalgia pain or not.

And it is disingenuous to suggest otherwise.

Donna Gregory Burch was diagnosed with fibromyalgia in 2014 after several years of unexplained pain, fatigue and other symptoms. She was later diagnosed with chronic Lyme disease. Donna covers news, treatments, research and practical tips for living better with fibromyalgia and Lyme on her blog, FedUpWithFatigue.com. You can also find her on Facebook, Twitter and Pinterest. Donna is an award-winning journalist whose work has appeared online and in newspapers and magazines throughout Virginia, Delaware and Pennsylvania.

Pain Patients Worried About CDC Expanding Opioid Guideline

By Pat Anson, PNN Editor

 “These guidelines have been a disaster for people with chronic pain.” 

“The guideline is flat out wrong on facts, wrong on science and wrong on medical ethics.” 

“The CDC has no qualifications or authority to develop pain management guidelines, especially those pertaining to opioid therapy.” 

Those are just a few of the comments we received from nearly 4,200 pain patients and healthcare providers who participated in PNN’s survey on impending changes to the CDC's opioid prescribing guideline. 

“It has been misunderstood, misapplied, bastardized and weaponized to use against chronic pain patients,” is how one pain sufferer put it.  

People obviously have strong opinions about the CDC guideline. Can it be changed and made more effective? Or should the entire guideline be thrown out? 

Nearly 75% of the people we surveyed believe the guideline should be withdrawn or revoked. That’s not likely to happen, however, as the CDC completes a lengthy review and update of the guideline that started two years ago.

If anything, the agency seems intent on expanding the guideline to include specific recommendations for treating short-term acute pain, migraine and possibly other pain conditions such as fibromyalgia. 

That’s the route recently taken by two advisory panels in Europe, which released guidelines that are even stricter on the use of opioids than the CDC’s.

WHAT SHOULD BE DONE WITH CDC OPIOID GUIDELINE?

This month the UK’s National Institute for Health and Care Excellence advised doctors not to prescribe opioids or any other pain reliever for fibromyalgia, chronic headache, musculoskeletal pain and other types of “primary chronic pain” for which there is no known cause.

In March, the European Pain Federation (EFIC) released similar guidelines, saying “opioids should not be prescribed for people with chronic primary pain as they do not work for these patients.”

At least two members of Physicians for Responsible Opioid Prescribing (PROP), an anti-opioid activist group, served as consultants to the EFIC in making its recommendation. PROP has long urged the CDC to make a similar statement in its guideline.

“This recommendation should explicitly state that opioids should be avoided for fibromyalgia, chronic headache and chronic low back pain,” PROP’s board wrote in a 2015 letter to the CDC’s Dr. Deborah Dowell, one of the co-authors of the 2016 guideline. “We are suggesting this change because evidence-based reviews and expert consensus have found the long-term use of opioids is likely to be counter-productive for fibromyalgia, chronic headache and chronic axial low back pain.”

PROP didn’t get its explicit statement in 2016, but it may be getting another chance as the CDC revises and possibly expands its guideline.

Little Support for Guideline Expansion

In our survey, patients and providers seem to be wary about expanding the guideline to include treatment recommendations for specific conditions. Only about 40% support guidelines for low back pain, fibromyalgia and short-term acute pain. Many believe the CDC has already gone too far and some wonder where the agency gets the regulatory authority to create guidelines for medical conditions.    

“CDC should never have developed and issued opioid prescribing guideline, as such work falls outside CDC's mission and expertise. If guidelines are needed, FDA should write,” one respondent said.

“The CDC guideline would be fine, if if were not being weaponized. There is nothing wrong with having guidelines for non-specialists. However, insurance companies have grabbed hold of it and are now using it to deny coverage of what they think is outside the guidelines,” said another.  

“Pain and it’s treatment should have a guideline but with the acknowledgment that its never one size fits all,” a patient wrote. “Some standardized measures are useful to help physicians make decisions in acute, cancer, non-cancer pain, and non-narcotic options should be sought first.”

SHOULD CDC MAKE RECOMMENDATIONS FOR TREATING LOW BACK PAIN, FIBROMYLAGIA AND OTHER PAIN CONDITIONS?

Strong Opposition to 90 MME Limit

If there’s anything that patients and providers want changed, it’s the guideline’s recommended dose limit of 90 MME (morphine milligram equivalent). Although voluntary, the daily dose limit has been rigidly applied by many doctors, pharmacists, insurers and regulators. As a result, patients who’ve taken higher doses of opioids for years — and done it safely — suddenly found themselves being tapered to 90 MME or less.

“My spouse has Ehlers Danlos Syndrome. Her chronic severe pain kept her bedridden for years until a doctor found an opioid regimen that worked. She had her life back and was able to function out of bed. This worked for over 12 years,” one man told us.

“Now, the CDC guidelines have caused local practitioners to require cutting her MME equivalent per day from about 300 to 90. They fear liability. When they discuss tapering and are confronted with the question, ‘But this is a genetic tissue disorder, it is not going to taper away,’ they have nothing to say except to point the finger at the CDC and say they are afraid of being sued. This is going to put her back in bed and, I'm afraid, kill her.”

Asked what changes should be made to the CDC’s recommended dose limit of 90 MME, nearly 87% said there should be no limit on opioid dosages.

“My doctor drastically reduced my medication and I suffer for it. Can hardly walk, can't function like I want to, no one cares as long as its 90 MME. Doesn't matter if I require higher dose and have tolerated it just fine for years,” a patient said.

“I was force tapered in 2016. I've been unable to fill legitimate prescriptions several times and denied meds by my insurance unless I use what they say is equivalent,” a patient told us.

“I was forced tapered from 550mg down to 90mg without my consent,” another patient wrote.

“Pretty much told that I would either take the lower prescribed dose or suck it up without pain relief,” said another.

WHAT CHANGES SHOULD BE MADE TO CDC'S DOSE LIMIT OF 90 MME?

“All of a sudden you can't have your regular prescription. Doesn't matter if it effects my health adversely. Blood pressure through the roof, NEVER had that problem before with it, but keep that 90 MME no matter what. Doctors sympathize but they are too scared to help you,” another patient said. “This rule doesn't help chronic pain patients at all and it doesn't stop overdoses. It needs to change.”

“My physician has been told by the hospital board that they have to reduce the amount of pain medication to ALL patients to an equivalent of 90mg. I have been taken off 70mg of my pain medications that I have taken for over 20 years,” wrote yet another patient.

“The doctor has told me he must continue to taper me more. He knows I am suffering but his hands are tied. The CDC must allow physicians that are experts in the pain management field to treat their patients as individuals. I have a lot more to say but can not type anymore as it causes me great amount of pain to use my hands and fingers.”

We received thousands of comments like these from patients, doctors, caretakers, spouses and loved ones.

One of the more poignant ones came from an intractable pain patient who considers herself lucky to have a doctor who slowly tapered her down to 90 MME. That doctor has now retired. She fears for her future and those of other patients.

“It’s my feeling we’ll look back on all this one day and realize this was in every aspect of the word a genocide; an attack on the weakest of us, the ones who most needed protection, but were mercilessly denied it.”

— Intractable Pain Patient

“I’ve managed to get to 90 MME from a dose much higher, as I was most definitely a high dose patient, but it only happened because I had good care for all those years,” she said. “I experience more nerve pain now than ever before, and I still very much fear being cut off.

“God bless any doctor or human being who’s willing to support us during this terrible most tragic of times. We’re being put in a position to lose all semblance of pain management for good if this downward spiral is allowed to continue. That’s such an inhumane and ugly thing to do, after countless lovely vibrant lives have been snuffed out by the lack of it already. It’s my feeling we’ll look back on all this one day and realize this was in every aspect of the word a genocide; an attack on the weakest of us, the ones who most needed protection, but were mercilessly denied it.”

(PNN’s survey was conducted online and through social media from March 15 to April 17. A total of 4,185 people in the United States participated, including 3,926 who identified themselves as chronic, acute or intractable pain patients; 92 doctors or healthcare providers; and 167 people who said they were a caretaker, spouse, loved one or friend of a patient. Thanks to everyone who participated in this valuable survey. To see the full survey findings, click here.)

New European Guideline Says Opioids ‘Do Not Work’ for Many Types of Chronic Pain

By Pat Anson, PNN Editor

Calling opioid medication a “two edged sword,” the European Pain Federation (EFIC) has released new guidelines that strongly recommend against using opioids to treat fibromyalgia, low back pain, migraine, irritable bowel syndrome and other types of chronic non-cancer pain.

“The new recommendations advise that opioids should not be prescribed for people with chronic primary pain as they do not work for these patients,” the EFIC said in a statement.

However, the guideline states that low doses of opioids may be suitable for treating “secondary pain syndromes” caused by surgery, trauma, disease or nerve damage, but only after exercise, meditation and other non-pharmacological therapies are tried first.

“Opioids should neither be embraced as a cure‐all nor shunned as universally dangerous and inappropriate for chronic noncancer pain. They should only be used for some selected chronic noncancer pain syndromes if established non‐pharmacological and pharmacological treatment options have failed,” the guideline states. “In this context alone, opioid therapy can be a useful tool in achieving and maintaining an optimal level of pain control in some patients.”

Opioid pain relievers are not as widely used in Europe as they are in the United States or Canada. The EFIC said it was trying to “allay concerns over an opioid crisis” developing in Europe, as it has in North America.       

“As the leading pain science organisation in Europe, it is crucial that EFIC sets the agenda on issues such as opioids, where there are growing societal concerns. These recommendations clarify what role opioids should play in chronic pain management,” EFIC President Brona Fullen said in a statement.

The guideline’s lead author, Professor Winfried Häuser, said he and his colleagues tried to strike a middle ground on the use of opioids.

“The debate on opioid-prescribing for chronic non-cancer pain has become polarized: opioids are either seen as a dangerous risk for all patients, leading to addiction and deaths, or they are promoted as most potent pain killers for any type of pain,” said Häuser, who is an internal medicine specialist in Germany.

“Opioids are still important in the management of chronic non-cancer pain – but only in some selected chronic pain syndromes and only if established non-pharmacological and non-opioids analgesics have failed or are not tolerated.”

PROP Consulted for European Guideline

The guideline was developed by a 17-member task force composed of European experts in pain management, including 9 delegates selected by EFIC’s board “who advocate and who are critical with the use of opioids.” Only one delegate from Pain Alliance Europe represented patients.

The recommendations developed by the task force were reviewed by five outside experts, including Drs. Jane Ballantyne and Mark Sullivan, who belong to Physicians for Responsible Opioid Prescribing (PROP), an anti-opioid activist group in the U.S.  Ballantyne is PROP’s President, while Sullivan is a PROP board member. Several changes suggested by the outside experts were adopted.

Coincidentally, Ballantyne, Sullivan and three other PROP board members were involved in the drafting of the opioid guideline released in 2016 by the U.S. Centers for Disease Control and Prevention. That controversial guideline is now being rewritten by the CDC after voluminous complaints from patients and doctors that the recommendations led to forced tapering, withdrawal, uncontrolled pain and suicides.

Sullivan and two other PROP board members were also involved in drafting Canada’s 2017 opioid guideline, which was modeled after the CDC’s and provoked similar complaints from Canadian pain patients.

90 MME Recommended Limit

The CDC and Canadian opioid guidelines appear to have been used as resources by the EFIC task force, which adopted many of the same recommendations, even while acknowledging the low quality of evidence used to support them.   

One recommendation is straight out of the CDC guideline, advising European doctors to “start low and go slow.” Prescribers are urged to start patients on low doses of 50 morphine milligram equivalents (MME) or less a day and to avoid increasing the dosage above 90 MME/day.

One significant difference with the North American guidelines is that the EFIC recommends that opioids not be prescribed for fibromyalgia, migraines and other chronic “primary pain” conditions for which there is no known cause – suggesting those disorders have an emotional or psychological element that will lead to opioid abuse.

“Prescription of high doses of opioids to patients with primary pain syndromes might have been a factor driving the opioid crisis in North America,” the EFIC guideline warns.

“This was further compounded by patient characteristics that included physical and psychological trauma, social disadvantage and hopelessness that served as a trigger for reports of pain intensity prompting prescriptions of more opioids.”

Secondary pain conditions for which opioids “can be considered“ include multiple sclerosis, stroke, restless leg syndrome, Parkinson’s disease, rheumatoid arthritis, phantom limb pain, non-diabetic neuropathy, spinal cord injuries and Complex Regional Pain Syndrome (CRPS). 

Unlike the North American guidelines, the EFIC acknowledges that there are physical and genetic differences between patients. Some patients who are rapid metabolizers “might require higher dosages of opioids than the ones recommended by the guidelines.“

EFIC GRAPHIC

The EFIC also warns that its guideline should not be used to justify abruptly tapering or discontinuing opioids for anyone already prescribed at higher dosages. The recommendations are also not intended for the management of short-term acute pain, sickle cell disease or end-of-life care.

Insurance Claims Show Lyme Disease More Widespread

By Pat Anson, PNN Editor

A new analysis of insurance claims by the Centers for Disease Control and Prevention suggests that Lyme disease may be far more widespread in the United States than current estimates.

CDC researchers looked at data from MarketScan, a large commercial insurance claims database, and found that Lyme disease diagnoses from 2010 to 2018 were six to eight times higher than the number of cases reported to a federal disease surveillance program.

Lyme disease is a bacterial illness spread by ticks. When left untreated, it can lead to chronic disorders such as fatigue, muscle and joint pain, cognitive issues and other symptoms that are often diagnosed as fibromyalgia, neuropathy and autoimmune disorders.

Most reported cases of Lyme disease occur in 14 states in the Northeast, mid-Atlantic and upper Midwest, especially during the summer months when more people spend time outdoors. Recent studies show Lyme is spreading to neighboring states and is no longer just a seasonal disease, possibly do to the effects of climate change.

The CDC analysis of insurance claims filed by nearly 23 million Americans identified over 140,000 people who were diagnosed with Lyme disease during the study period. That works out to a nationwide rate of 73 cases for every 100,000 people, a rate substantially higher than the 9 cases per 100,000 reported by the surveillance program.

“Age and sex distributions among Lyme disease diagnoses in MarketScan were similar to those of cases reported through surveillance, but proportionally more diagnoses occurred outside of peak summer months, among female enrollees, and outside high-incidence states,” wrote lead author Amy Schwartz, an epidemiologist in the CDC’s Bacterial Diseases Branch.

Schwartz and her colleagues say the larger number of Lyme cases reported by MarketScan may be the result of misdiagnoses, but the volume of claims warrant further investigation.

“Although Lyme disease diagnoses identified from claims data are not supported by the robust evidence of infection required for surveillance reporting, they are a consistent indicator of trends in the healthcare system. In addition, the sheer volume of data available through MarketScan provides potential for new insights into the epidemiology of Lyme disease diagnoses in the United States,” they said.

The CDC findings are similar to a 2017 analysis of insurance claims by the non-profit FAIR Health, which found an unexpected surge in Lyme disease cases during the winter and early spring.

Early symptoms of Lyme disease include fever, chills, headache, fatigue, muscle and joint aches, and swollen lymph nodes. A delayed rash often appears at the site of the tick bite. The rash grows in size and sometimes resembles a bulls-eye. Lyme disease is usually treated with antibiotics.

About 30,000 cases of Lyme disease are reported annually by state and local health departments to the surveillance program. The CDC acknowledges, however, that the actual number of cases is probably much higher and that about 300,000 Americans may become infected every year.