Lab Mice Agree: Delta-8 Just Like Taking Delta-9

By Pat Anson, PNN Editor

Laboratory mice at a research facility have figured out something that Congress failed to do when it legalized hemp in 2018: the tetrahydrocannabinol (THC) found in hemp can get you just as high as the THC found in marijuana.

That finding, in a new study led by researchers at the University of Connecticut, undermines one of the tenets of the 2018 Farm Bill, which made it possible for U.S. farmers to grow hemp again as a cash crop. The thinking at the time was that since hemp contained less than 0.3% tetrahydrocannabinol, the main psychoactive ingredient in marijuana, it couldn’t be used to get high.

The mice found otherwise. When given Delta-8 THC derived from hemp twice a day for five days, the mice showed signs of lethargy, dependence and “liking” behavior. Although not as potent as the Delta-9 THC derived from marijuana, researchers reported in the journal Drug and Alcohol Dependence that Delta-8 had similar psychoactive effects on the mice, “including evidence of dependence and abuse potential.”

“So they’re telling us the same thing people buying the stuff in gas stations tell us: (Delta-8) feels like THC,” says Steve Kinsey, PhD, a UConn School of Nursing professor and director of the Center for Advancement in Managing Pain.

Kinsey and his colleagues say Delta-8 and Delta-9 molecules are similar and act in the same way on the body. But while Delta-9 is illegal under federal law, Delta-8 is legally being sold in a wide array of edibles, beverages, tinctures and other products. Because they are made with CBD and THC derived from hemp, they can be purchased without an ID or marijuana prescription – even in states where medical or recreational marijuana is illegal.  A recent study found that some hemp-based edibles have 360% more THC than those sold in cannabis dispensaries.

“It’s creating a fight between marijuana and hemp” growers, says John Harloe, an attorney on a Colorado taskforce that is trying to address the different chemical variations of THC and their hazy legal status.

“(Marijuana) must be sold through dispensaries and pay high taxes, while hemp producers can sell essentially the same product but without the same regulations, due to the ambiguity in the Farm Bill,” Harloe said in a statement.

The Food and Drug Administration has been slow to regulate CBD products, but earlier this year the agency sent the first warning letters to companies for selling products containing Delta-8. The letters don’t take issue with Delta-8’s legal status, but focus instead on its unauthorized marketing as a treatment for chronic pain, nausea, anxiety and even cancer.

Experimental Vaccines Target Epstein-Barr Virus

By Liz Szabo, Kaiser Health News

Maybe you’ve never heard of the Epstein-Barr virus. But it knows all about you.

Chances are, it’s living inside you right now. About 95% of American adults are infected sometime in their lives. And once infected, the virus stays with you.

Most viruses, such as influenza, just come and go. A healthy immune system attacks them, kills them, and prevents them from sickening you again. Epstein-Barr and its cousins, including the viruses that cause chickenpox and herpes, can hibernate inside your cells for decades.

This viral family has “evolved with us for millions of years,” said Blossom Damania, a virologist at the University of North Carolina-Chapel Hill. “They know all your body’s secrets.”

Although childhood Epstein-Barr infections are typically mild, exposure in teens and young adults can lead to infectious mononucleosis, a weeks-long illness that sickens 125,000 Americans a year, causing sore throats, swollen glands, and extreme fatigue. And while Epstein-Barr spends most of its time sleeping, it can reawaken during times of stress or when the immune system is off its game. Those reactivations are linked to a long list of serious health conditions, including several types of cancer and autoimmune diseases.

Scientists have spent years trying to develop vaccines against Epstein-Barr, or EBV. But recently several leaps in medical research have provided more urgency to the quest — and more hope for success. In just the past year, two experimental vaccine efforts have made it to human clinical trials.

What’s changed?

First, the Epstein-Barr virus has been shown to present an even greater threat. New research firmly links it to multiple sclerosis, or MS, a potentially disabling chronic disease that afflicts more than 900,000 Americans and 2.8 million people worldwide.

The journal Science in January published results from a landmark 20-year study of 10 million military personnel that offers the strongest evidence yet that Epstein-Barr can trigger MS. The new study found that people infected with Epstein-Barr are 32 times as likely as people not infected to develop MS.

And shedding new light on the mechanisms that could explain that correlation, a separate group of scientists published a study in Nature describing how the virus can cause an autoimmune reaction that leads to MS.

The disease, which usually strikes between ages 20 and 40, disrupts communication between the brain and other parts of the body and is often marked by recurring episodes of extreme fatigue, blurred vision, muscle weakness, and difficulty with balance and coordination. At its worst, MS can lead to impaired speech and paralysis.

Now that we know that Epstein-Barr is very tightly linked to MS, we could save a lot of lives if we develop the vaccine now.
— Blossom Damania, Virologist

Amplifying that newfound urgency, several new studies suggest that reactivation of the Epstein-Barr virus also is involved with some cases of long covid, a little-understood condition in which patients experience lingering symptoms that often resemble mononucleosis.

And just as crucial to the momentum: Advances in vaccine science spurred by the pandemic, including the mRNA technology used in some covid vaccines, could accelerate development of other vaccines, including ones against Epstein-Barr, said Dr. Peter Hotez, dean of the National School of Tropical Medicine at Baylor College of Medicine. Hotez co-created a low-cost, patent-free covid vaccine called Corbevax.

Some researchers question the need for a vaccine that targets a disease like MS that, while debilitating, remains relatively rare.

Eliminating Epstein-Barr would require vaccinating all healthy children even though their risk of developing cancer or multiple sclerosis is small, said Dr. Ralph Horwitz, a professor at the Lewis Katz School of Medicine at Temple University.

Before exposing children to the potential risks of a new vaccine, he said, scientists need to answer basic questions about MS. For example, why does a virus that affects nearly everyone cause disease in a small fraction? And what roles do stress and other environmental conditions play in that equation?

The answer appears to be that Epstein-Barr is “necessary but not sufficient” to cause disease, said immunologist Bruce Bebo, executive vice president for research at the National MS Society, adding that the virus “may be the first in a string of dominoes.”

‘We Could Save a Lot of Lives’

Hotez said researchers could continue to probe the mysteries surrounding Epstein-Barr and MS even as the vaccine efforts proceed. Further study is required to understand which populations might benefit most from a vaccine, and once more is known, Hotez said, such a vaccine possibly could be used in patients found to be at highest risk, such as organ transplant recipients, rather than administered universally to all young people.

“Now that we know that Epstein-Barr is very tightly linked to MS, we could save a lot of lives if we develop the vaccine now,” Damania said, “rather than wait 10 years” until every question is answered.

Moderna and the National Institute of Allergy and Infectious Diseases launched separate clinical trials of Epstein-Barr vaccines over the past year. Epstein-Barr vaccines also are in early stages of testing at Opko Health, a Miami-based biotech company; Seattle’s Fred Hutchinson Cancer Center; and California’s City of Hope National Medical Center.

Scientists have sought to develop vaccines against Epstein-Barr for decades only to be thwarted by the complexities of the virus. Epstein-Barr “is a master of evading the immune system,” said Dr. Jessica Durkee-Shock, a clinical immunologist and principal investigator for NIAID’s trial.

Both MS and the cancers linked to Epstein-Barr develop many years after people are infected. So a trial designed to learn whether a vaccine can prevent these diseases would take decades and a lot of money.

Moderna researchers initially are focusing on a goal more easily measured: the prevention of mononucleosis, which doubles the risk of multiple sclerosis. Mono develops only a month or so after people are infected with Epstein-Barr, so scientists won’t have to wait as long for results.

Mono can be incredibly disruptive on its own, keeping students out of class and military recruits out of training for weeks. In about 10% of cases, the crippling fatigue lasts six months or more. In 1% of cases, patients develop complications, including hepatitis and neurological problems.

For now, the clinical trials for Epstein-Barr immunizations are enrolling only adults. “In the future, the perfect vaccine would be given to a small child,” Durkee-Shock said. “And it would protect them their whole life, and prevent them from getting mono or any other complication from the Epstein-Barr virus.”

The NIAID vaccine, being tested for safety in 40 volunteers, is built around ferritin, an iron-storage protein that can be manipulated to display a key viral protein to the immune system. Like a cartoon Transformer, the ferritin nanoparticle self-assembles into what looks like a “little iron soccer ball,” Durkee-Shock said. “This approach, in which many copies of the EBV protein are displayed on a single particle, has proved successful for other vaccines, including the HPV and hepatitis B vaccine.”

Moderna’s experimental vaccine, being tested in about 270 people, works more like the company’s covid shot. Both deliver snippets of a virus’s genetic information in molecules called mRNA inside a lipid nanoparticle, or tiny bubble of fat. Moderna, which has dozens of mRNA vaccines in development, hopes to learn from each and apply those lessons to Epstein-Barr, said Sumana Chandramouli, senior director and research program leader for infectious diseases at Moderna.

“What the covid vaccine has shown us is that the mRNA technology is well tolerated, very safe, and highly efficacious,” Chandramouli said.

But mRNA vaccines have limitations.

Although they have saved millions of lives during the covid pandemic, the antibody levels generated in response to the mRNA vaccines wane after a few months. It’s possible this rapid loss of antibodies is related specifically to the coronavirus and its rapidly evolving new strains, Hotez said. But if waning immunity is inherent in the mRNA technology, that could seriously limit future vaccines.

Designing vaccines against Epstein-Barr is also more complicated than for covid. The Epstein-Barr virus and other herpesviruses are comparatively huge, four to five times as large as SARS-CoV-2, the coronavirus that causes covid. And while the coronavirus uses just one protein to infect human cells, the Epstein-Barr virus uses many, four of which are included in the Moderna vaccine.

Earlier experimental Epstein-Barr vaccines targeting one viral protein lowered the rate of infectious mononucleosis but failed to prevent viral infection. Targeting multiple viral proteins may be more effective at preventing infection, said Damania, the UNC virologist.

“If you close one door, the other door is still open,” Damania said. “You have to block infection in all cell types to have a successful vaccine that prevents future infections.”

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

Thinking Outside the Pill Box: Another Approach to Pain Management

By Alon Ironi, CEO, Theranica Bio-Electronics

Well into my adulthood, I struggled with chronic back pain. I took medication after medication, finding myself getting sucked into the habit of popping painkillers and wondering why my pain wasn’t healing. I eventually discovered the psychological and mental elements inherent in chronic pain, and shifted my approach to pain management, which rapidly cured my back pain.  

The holistic approach to healing pain has historically been ridiculed in the medical community, preventing many physicians from recognizing the legitimacy of alternative treatments. The time has come to evolve beyond just popping pills to treat pain, towards a biopsychosocial perspective.  

The discovery and introduction of penicillin in 1928, marked the very beginning of medication popularization in the West. The development of new medications – for a wide range of uses - has extended life span and improved quality of life.  Unfortunately, the benefits associated with medication have encouraged its frequent use for disorders it simply is not meant for, such as certain types of chronic pain.  

Medication overuse headache is one example where drugs intended to treat migraine and headache can, with excessive use, lead to the deterioration of the exact condition they are supposed to be treating. Medication is an incredible tool when used properly, but it’s not the only tool, and it can be seriously harmful when misapplied.

What is Pain and How Do We Treat It? 

Pain is a unique bodily experience that, unlike other disorders, indicates an underlying issue in one’s physiology. Pain is an alarm system. It tells us that something is wrong, and if we mask it without treating its underlying cause, we might cause a great disservice to our bodies.  

The use of medication to treat short-term acute pain, while a person simultaneously heals from the cause of that pain, like a pulled muscle or a tear in a tissue, makes sense. However, the use of medication in instances of chronic pain - pain that persists longer than three months - is problematic.  

Chronic pain is a debilitating condition that impacts an individual’s everyday life. From migraine to chronic knee pain to chronic back pain, the routine of normal life is disrupted. Often, this chronic pain had an initial cause, such as a surgery, fall or injury that has since healed, but the pain persists long after its source has disappeared. This type of pain, as Haider Warraich, a physician and clinical researcher at Harvard, so aptly puts it, is like “an overlearned traumatic memory that keeps ricocheting around in our brains, often long after the injury it rehearses has fully healed.” 

This perception of chronic pain has its roots in quite a controversial physician -the late Jon Sarno, MD, a professor of rehabilitation medicine in the 1980’s and 90’s. His theories, while not rigorously proven in formal clinical studies, were built upon anecdotal data from thousands of patients he treated during his lifetime and are still being explored today. They have jumpstarted a revolution in our understanding of pain.  

The biopsychosocial model focuses on illness as a complex interaction of chemical and electrical reactions that are induced by biological, psychological and social factors. Contemporary pain researchers, like Lorimer Mosely, a clinical scientist, have applied this model to pain, recognizing that pain is comprised of both physical sensation and emotional stimulus, such as the fear of pain itself.  

Pain is no longer perceived as entirely “physical” in nature. It is now understood to be exacerbated by the fear of tissue damage and the aversion to previously experienced pain. As clinical research develops and shifts its focus to a more biopsychosocial approach to illness and pain, doctors must re-evaluate their first-line treatment suggestions. 

Drug-Free Pain Management 

Based on this new perception of pain, several nonpharmacological treatment methods for pain management have been developed. One approach is a purely psychological treatment called cognitive behavioral therapy, a form of talk therapy that discourages negative thoughts associated with pain and trains people to adhere to thoughts that stimulate the body’s natural pain relief system. Another example of nonpharmacological pain treatment is massage therapy,  which addresses pain by releasing muscle tension.  

Neuromodulation is highly effective in treating certain pain disorders through the use of electrical stimulation to modulate pain pathways in the neural system.  Several forms of neuromodulation treatment exist today, with different mechanisms of action and efficacy.  

Spinal cord stimulation, for example, is used to treat back pain and leg pain. But it is highly invasive, with electrodes surgically placed near the spinal cord to send electrical currents to the spine.

Deep brain stimulation is being studied for the relief of chronic pain, but it is also quite invasive, as it involves implanting electrodes into the brain.  

Nerivio is a non-invasive, wearable neuromodulation device made by my company that is FDA-approved for the treatment of acute migraine. Nerivio is self-applied to the upper arm, where it uses remote electrical neuromodulation (REN) to stimulate analgesic neurotransmitters in the pain pathways of migraine. In clinical trials, Nerivio and other REN devices have been shown to be just as effective as pharmacological treatments.  

To be clear, medication is a necessary and beneficial tool for treating infections, reducing fever, managing sickness and much more. However, its use in chronic pain management is sometimes misplaced, especially at a time when newer non-drug therapies are emerging.  

The holistic approach to pain management is the future. It considers the balance and context of a patient’s life and combines multiple modalities for their treatment. People are multifaceted and their treatment should be multifaceted as well. It is my hope and vision that this field of research will continue to develop and will soon be widely embraced by most medical professionals.  

Having experienced the benefits of drug-free pain management first-hand, I truly hope that health care systems will support patients in accessing these much-needed alternative treatments to improve quality of care and life.  

Alon Ironi is the CEO and co-founder of Theranica Bio-Electronics, the developer of Nerivio.

Alon received a Master of Science in Electrical Engineering from Santa Clara University, and a Bachelor’s of Science in Electrical Engineering from the Technion- Israel Institute of Technology.

Is Another Covid Spike Coming? 6 Tips to Help You Stay Safe

By Celine Gounder, Kaiser Health News

The emergence last year of the highly transmissible omicron variant of the covid-19 virus caught many people by surprise, and led to a surge in cases that overwhelmed hospitals and drove up fatalities. Now we’re learning that omicron is mutating further to better evade the immune system.

Omicron-specific vaccines were authorized by the FDA in August and are recommended by U.S. health officials for anyone 5 or older. Yet only half of adults in the United States have heard much about these booster shots, according to a recent Kaiser Family Foundation poll, and only a third say they’ve gotten one or plan to get one as soon as possible. In 2020 and 2021, covid cases spiked in the U.S. between November and February.

Although we don’t know for sure that we’ll see another surge this winter, here’s what you should know about covid and the updated boosters to prepare.

1. Do I need a covid booster shot this fall?

If you’ve completed a primary vaccination series and are 50 or older, or if your immune system is compromised, get a covid booster shot as soon as possible. Forty percent of deaths are occurring among people 85 and older and almost 90% among people 65 and over. Although people of all ages are being hospitalized from covid, those hospitalizations are also skewing older.

Unvaccinated people, while in the minority in the U.S., are still at the highest risk of dying from covid. It’s not too late to get vaccinated ahead of this winter season. The United Kingdom, whose covid waves have presaged those in the United States by about a month, is beginning to see another increase in cases.

If you’ve already received three or more covid shots, you’re 12 to 49 years old, and you’re not immunocompromised, your risk of hospitalization and death from the disease is significantly reduced and additional boosters are not likely to add much protection.

However, getting a booster shot provides a “honeymoon” period for a couple of months after vaccination, during which you’re less likely to get infected and thus less likely to transmit the virus to others. If you’ll be seeing older, immunocompromised, or otherwise vulnerable family and friends over the winter holidays, you might want to get a booster two to four weeks in advance to better shield them against covid.

You may have other reasons for wanting to avoid infection, like not wanting to have to stay home from work because you or your child is sick with covid. Even if you aren’t hospitalized from covid, it can be costly to lose wages or arrange for backup child care.

One major caveat to these recommendations: You should wait four to six months after your last covid infection or vaccination before getting another shot. A dose administered too soon will be less effective because antibodies from the previous infection or vaccination will still be circulating in your blood and will prevent your immune cells from seeing and responding to vaccination.

2. Do kids need to be vaccinated even if they’ve had covid?

Although children are at lower risk for severe covid than are adults, the stakes for kids are higher than many diseases already recognized as dangerous. Their risk shouldn’t be measured against the risk that covid poses to other age groups but against the risk they face from other preventable diseases.

In the first two years of the pandemic, covid was the fourth- or fifth-leading cause of death in every five-year age bracket from birth to 19, killing almost 1,500 children and teenagers. Other vaccine-preventable diseases like chickenpox, rubella, and rotavirus killed an average of about 20-50 children and teens a year before vaccines became available. By that measure, vaccinating kids against covid is a slam-dunk.

Children who have had covid also benefit from vaccination. The vaccine reduces their risk of hospitalization and missing days of school, when parents might need to stay home with them.

But it’s precisely because the stakes are higher for kids that many parents are anxious about getting their children vaccinated. As recently as July, just after the FDA authorized covid vaccines for children as young as 6 months, a KFF poll found that over half of parents of children under age 5 said they thought vaccines posed a greater risk to the health of their child than getting the disease. And in the most recent poll, half said they had no plans to get their children vaccinated. Covid vaccination rates range from 61% among children ages 12 to 17 to 2% among kids younger than 2.

Similar to influenza, covid is most deadly for the very youngest and oldest. At especially high risk are infants. They’re unlikely to have immunity from infection, and a small share have been vaccinated. Unless their mothers were vaccinated during pregnancy or got covid during pregnancy — the latter of which poses a high risk of death for the mother and of preterm birth for the baby — infants are probably not getting protective antibodies against covid through breast milk. And because infants have small airways and weaker coughs, they’re more likely to have trouble breathing with any respiratory infection, even one less deadly than covid.

3. Will I need a covid shot every year?

It depends on the targets set by public health officials whether covid becomes a seasonal virus like the flu, and how much the virus continues to mutate and evade humanity’s immune defenses.

If the goal of vaccination is to prevent severe disease, hospitalization, and death, then many people will be well protected after their primary vaccination series and may not need additional shots. Public health officials might strongly recommend boosters for older and immunocompromised people while leaving the choice of whether to get boosted to those with lower risk. If the goal of vaccination is to prevent infection and transmission, then repeat boosters will be needed after completing the primary vaccination series and as often as a couple of times a year.

Influenza is a seasonal virus causing infections and disease generally in the winter, but scientists don’t know whether covid will settle into a similar, predictable pattern. In the first three years of the pandemic, the United States has experienced waves of infection in summer. But if the covid virus were to become a wintertime virus, public health officials might recommend yearly boosters. The Centers for Disease Control and Prevention recommends that people 6 months and older get a flu shot every year with very rare exceptions. However, as with the flu, public health officials might still place a special emphasis on vaccinating high-risk people against covid.

And the more the virus mutates, the more often public health officials may recommend boosting to overcome a new variant’s immune evasion. Unfortunately, this year’s updated omicron booster doesn’t appear to provide significantly better protection than the original boosters. Scientists are working on variant-proof vaccines that could retain their potency in the face of new variants.

4. Are more covid variants on the way?

The omicron variant has burst into an alphabet soup of subvariants. The BA.5 variant that surfaced earlier this year remains the dominant variant in the U.S., but the BA.4.6 omicron subvariant may be poised to become dominant in the United States. It now accounts for 14% of cases and is rising. The BA.4.6 omicron subvariant is better than BA.5 at dodging people’s immune defenses from both prior infection and vaccination.

In other parts of the world, BA.4.6 has been overtaken by BA.2.75 and BF.7 (a descendant of BA.5), which respectively account for fewer than 2% and 5% of covid cases in the U.S. The BA.2.75.2 omicron subvariant drove a wave of infections in South Asia in July and August. Although the U.S. hasn’t yet seen much in the way of another variant descended from BA.5 — BQ.1.1 — it is rising quickly in other countries like the U.K., Belgium, and Denmark. The BA.2.75.2 and BQ.1.1 variants may be the most immune-evasive omicron subvariants to date.

BA.4.6, BA.2.75.2, and BQ.1.1 all evade Evusheld, the monoclonal antibody used to prevent covid in immunocompromised people who don’t respond as well to vaccination. Although another medication, bebtelovimab, remains active in treating covid from BA.4.6 and BA.2.75.2, it’s ineffective against BQ.1.1. Many scientists are worried that Evusheld will become useless by November or December. This is concerning because the pipeline for new antiviral pills and monoclonal antibodies to treat covid is running dry without a guaranteed purchaser to ensure a market. In the past, the federal government guaranteed it would buy vaccines in bulk, but funding for that program has not been extended by Congress.

Other omicron subvariants on the horizon include BJ.1, BA.2.3.20, BN.1, and XBB, all descendants of BA.2.

It’s hard to predict whether an omicron subvariant or yet another variant will come to dominate this winter and whether hospitalizations and deaths will again surge in the U.S. Vaccination rates and experience with prior infections vary around the world and even within the United States, which means that the different versions of omicron are duking it out on different playing fields.

While this might all sound grim, it’s important to remember that covid booster shots can help overcome immune evasion by the predominant omicron subvariants.

5. What about long covid?

Getting vaccinated does reduce the risk of getting long covid, but it’s unclear by how much. Researchers don’t know if the only way to prevent long covid is to prevent infection.

Although vaccines may curb the risk of infection, few vaccines prevent all or almost all infections. Additional measures — such as improving indoor air quality and donning masks — would be needed to reduce the risk of infection. It’s also not yet known whether prompt treatment with currently available monoclonal antibodies and antiviral drugs like Paxlovid reduces the risk of developing long covid.

6. Do I need a flu shot, too?

The CDC recommends that anyone 6 months of age or older get an annual flu shot. The ideal timing is late October or early November, before the winter holidays and before influenza typically starts spreading in the U.S. Like covid shots, flu shots provide only a couple of months of immunity against infection and transmission, but an early flu shot is better than no flu shot. Influenza is already circulating in some parts of the United States.

It’s especially important for people 65 or older, pregnant women, people with chronic medical conditions, and children under 5 to get their yearly flu shots because they’re at highest risk of hospitalization and death. Although younger people might be at lower risk for severe flu, they can act as vectors for transmission of influenza to higher-risk people in the community.

High-dose flu vaccines and “adjuvanted” flu vaccines are recommended for people 65 and older. Adjuvants strengthen the immune response to a vaccine. It is safe to get vaccinated for covid and the flu at the same time, but you might experience more side effects like fevers, headache, or body aches.

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

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.  

The One Unacceptable Thing a Person in Pain Can Do

By Mia Maysack, PNN Columnist 

Someone once asked me, "If there were one thing to educate the public about on how people in pain live, what would it be?"  

My first thought was, “Where should I start?" 

By definition, chronic pain is pain that persists for at least three months despite medication or treatment. The pain may be caused by any number of medical conditions, diseases, trauma or injury.

Some of us live with chronic pain that most “healthy” people can’t begin to relate to. It’s not like your last stomach flu, hangover, stubbed toe or whack on your not-so-funny bone. You’ll quickly get over those.

Consider the possibility of having pain that never ends. You try countless therapies, medications and changes in lifestyle that may help for a short time, but are far from a cure-all. Many of the suggestions you get -- whether asked for or not -- also haven't proven viable.   

Although I'm fortunate to be alive, migraines and cluster headaches caused by a traumatic brain injury have been my daily companions for over two decades. There’s not much I can do to ease my head pain, and I went through many years experimenting with treatments that only made things worse.      

Some scary statistical facts about pain:

  • About 20% of American adults – 50.2 million people – have chronic pain, 19.6 million of which have “high-impact” pain that limits their life and work activities 

  • Chronic pain raises the risk of many other health problems, including dementia, high blood pressure, insomnia, anxiety and depression

  • The average veterinary student in the United States get five times more education hours focused on treating pain in animals than a medical student does in treating humans

  • Even though chronic pain is the number one reason for accessing healthcare and the leading cause of disability, only two percent of the National Institute of Health’s budget goes to pain research  

Let's go back to the thought of a sprained ankle, toothache, seasonal cold or a mild burn. Imagine coming across something that actually helped ease that hardship, but having it taken from away suddenly, and then being refused or abandoned as a patient. That’s what many of us with pain have experienced.

In the face of all this, there does come a point when it's our responsibility to raise awareness about pain and to help find solutions that we all desperately want. This requires some effort on our end.  And it's disheartening to encounter people who won't lift a finger to work towards a solution to our own causes. 

Recently I was discussing important legislation with other individuals living with pain, who all said they were personally impacted by the issue. When I proceeded to explain the next steps needed regarding policy, I saw their eyes glaze over. One even whipped out their phone in disinterest, while everyone else seemingly groaned in discontent.  Even in our own community, we don’t always show up for the sake of ourselves or each other.

It goes without saying that not everyone is interested in or even able to travel to Washington DC for a congressional meeting. The same is true for attending rallies, running support groups, or just sharing their story on a public forum. But someone has to. There are things we can do that will help us inch closer toward change and relief for millions. 

Our individual experiences are valuable and whether you live in a state of physical hurt or not, we must begin to care more about one another on a fundamental level.  Pain is ultimately something that'll impact everyone. Why wait for pain to happen to you? Why accept the fact that it already has?  

One of the biggest myths is that there's only certain acceptable ways to advocate for ourselves or each other. In actuality, there's only one unacceptable thing to do. And that is nothing. 

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. Mia is the recipient of the International Pain Foundation’s “Hero of Hope” award for 2022.

FDA Approves Device That Uses Artificial Intelligence to Treat Chronic Pain

By Pat Anson, PNN Editor

The Nevro Corporation says it has won approval from the Food and Drug Administration for an advanced spinal cord stimulator (SCS) that uses artificial intelligence to individualize treatment for each patient.

Nevro says its Senza HFX iQ stimulator “learns from patients” as they use the device and develops customized algorithms for treating chronic back pain, leg pain and pain from diabetic neuropathy.

"HFX iQ is designed to improve the consistency of pain relief and is the only SCS system that truly personalizes care," D. Keith Grossman, Chair and CEO of Nevro, said in news release.

"Pain is variable from patient to patient and over time. Using the big data from our HFX Cloud patient database, our unique HFX Algorithm was developed to identify those programs where patients have been more likely to get relief in the real world.  HFX iQ takes direct input from each patient on their pain and quality of life measures to get smarter over time and recommend program changes.”

Nevro says patients will start with a program most likely to provide pain relief, and then adjusts it over time based on patient input and medical data, such as pain scores, activity levels and changes in use of pain medication. Patients can also adjust their pain relief programs through an app on their smartphones.

Spinal cord stimulators are usually considered the treatment of last resort for people with intractable or severe chronic pain that doesn’t respond to other therapies. The surgically implanted devices emit low levels of electricity that reduce the intensity of pain signals.

Unlike older stimulators, Senza stimulators use electric pulses of 10 kHz, a high frequency that doesn’t create an uncomfortable tingling sensation and delivers more pain relief. Last year the FDA approved Senza stimulators for the treatment of painful diabetic neuropathy, making it the first spinal cord stimulation system approved for that condition. Until then, most SCS devices were only approved for patients with severe back pain.

About 50,000 stimulators are implanted in the U.S. every year, with failure rates for the devices estimated at 25 to 30 percent. Most patients are required to undergo psychological testing and a trial treatment before getting a SCS.

The FDA has come under scrutiny for its regulation of stimulators and other medical devices.  A 2020 report by Public Citizen accused the FDA of “dangerously lax” oversight of stimulators, which were linked to 156,000 injuries and 931 deaths.  The agency responded to the report by sending a letter to healthcare providers reminding them to only implant stimulators after a trial period that demonstrates the device are effective. An FDA review of adverse events involving stimulators found that nearly a third were reports of unsatisfactory pain relief.

Nevro says it will begin a limited release of Senza HFX iQ later this year, with a full market launch in the U.S. in early 2023. Nevro is also seeking approval of HFX iQ in Europe.  

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. 

A Voice They Don’t Want to Hear

By Carol Levy, PNN Columnist

“Nothing about us without us.”

I did not know this clarion call was initially a slogan of the disabled community, which wanted a seat at the table when policies were created affecting the disabled. It also pertains to the pain community and our place in the fight against the “war on opioids.”

I am a member of my county's opioid task force. I was invited by a commissioner, an anesthesiologist, who has chronic pain patients. The commission's goal is to find ways to prevent drug abuse, how to treat those who are addicted, and how to fight opioid addiction. 

We had our second meeting a few days ago. In this group, I have become the voice of the pain community, a voice they don't want to hear.

At the first meeting, after hearing about opioids from an emergency room doctor, an EMT, a sheriff, and a recovering addict MD, we broke into smaller groups of 5 or 6 people. I tried to make my voice heard.

“Please, when you speak of addiction starting with painkillers, it needs to be made clear that the people abusing opioids are not the same as those who get legitimate prescriptions for legitimate pain,” I said, adding that studies show we rarely get addicted.

But another woman had a louder voice. Her story was sad, an addicted son who died from an overdose. Every time I tried to speak, she spoke over me. As the meeting progressed, the rest of the group turned to her and very specifically away from me. I was ignored for the rest of the meeting.

At the end, when we were to present our feelings and thoughts about what was needed in the fight against addiction, my voice was absent. 

The second meeting was run the same way. When we broke into our groups, I immediately spoke up. Eyes turned towards me as if to listen, but as soon as I finished my few sentences they turned away. I tried a few times more, louder each time, but was still mostly ignored.  

At one point a woman who runs a recovery house spoke the sentence I abhor: "Many of the addicts start with painkillers...”  

I immediately responded: “There needs to be an asterisk anytime that sentence is spoken. Studies show chronic pain patients rarely get addicted.”  

“I was not referring to those who need them,” she replied. 

“Then you need to add that as a parenthetical, so we don't keep getting swept up as part of the culprits in the war,” I urged.   

She shook her head, said “yeah sure” and went back to "they start with painkillers,” completely ignoring what I had said. 

At the end of the meeting, when we were asked to put on a poster board what we felt needed to be addressed, the leader completely omitted any suggestion that it needs to be made clear the pain community is not part of the problem. 

When it was over, I sought out one of the organizers and told her, “I'm not sure there's a place for me, for the chronic pain community, at this table."

She said she would talk to the county commissioners who had formed the task force and get back to me. No one has. 

I don't know what else to do to get us included. “Nothing without us” in regards to the opioid task force seems to be “nothing about us.” And definitely without us.   

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.

Finding Peace While Fighting Cancer

By Cynthia Toussaint, PNN Columnist

It’s the damnedest thing. Despite this month being my 40-year anniversary with high impact pain, and while I battle an aggressive breast cancer recurrence, people tell me that I look healthy and happy.

Stranger still, I feel more grounded and centered than ever. In fact, I’m down-right peaceful. So much so, when I recently saw my osteopath, she said that I no longer needed her treatment because I was “in the flow.”  

After delving deep into this disconnect, I’ve unearthed the workings that have brought me to this sacred place. And now that I’m here, I plan to protect my peace.

To start, I’ve learned to neutralize platitudes and their associated shame. When people blow by the gravity of my cancer recurrence by assuring me that staying positive will save the day, I politely dismiss their cliché as unhealthy and unrealistic.

There’s no one alive who could face a second round of breast cancer without being mad as hell. That being said, I’ve given myself permission to move through the five stages of grieving – denial, anger, bargaining, depression and acceptance – which has allowed me to come to an authentic level of positivity… and peace.  

Also, I’ve taken control of my cancer care. This is a big deal. After listening to my oncologist’s by-the-book treatment plan, I shared that, while well-intended, I thought his recommendations would kill me.

Instead, he and I sought guidance from trusted sources, and agreed on a plan that was tailored to my individual needs, including the complications that Complex Regional Pain Syndrome present. I won’t lie to you, the treatment is at times brutal. But I’m choosing it, and with control comes peace. 

And there was a miracle.

With the synergy of my current treatment (low dose chemo, immunotherapy infusions and a robust dose of self-care), my tumor quickly dissolved from the size of a ping pong ball to one that can’t be found. Wearing a Cheshire cat grin, my oncologist recently shared that in his 45-year career he’s never seen such a response.

So how did my body do that? Yes, the med cocktail certainly played its part, but I’m convinced that finding peace is my secret sauce to healing.

Besides taking control of my medical care, I’ve become religious about upping my terrain-game for the healthiest body and mind. I’ve switched to a vegan diet with lots of fish, committed to an hour-long workout each morning, get in bed early to promote deep sleep, and have radically reduced my stress by identifying and removing toxic people from my life. These are the self-care strategies we hear of time and again, and for good reason. When practiced, they work! 

Letting Go of Trauma

For more peace, I’ve vastly upped my game by adding a “paths-less-taken” approach.

Like most of us with pain, I suffered much childhood trauma, the foundation of my un-wellness. I’m working diligently on trauma release using various methods, one being forgiveness. Through daily visualization and meditation, I’m practicing the art of letting go of trespasses.

Instead of allowing anger and hurt to turn into psychic stagnation, I acknowledge the negative emotion, thank it for lessons learned, and send it on its way. Forgiveness is a choice, and I’ve decided to free myself from poisonous energy so I can move forward with peace.

I often remind myself that when a person is cruel, it’s not about me, but rather a challenge they’re experiencing on their life path. And when I can, though still a work-in-progress, I light a candle and wish them well.

Most surprising, I recently stumbled upon my biggest trauma-releasing, peace-inducing tool, as I intuitively knew this blast-from-the-past would move my wellness ahead by eons.

Several months ago, I surprised myself by bringing my grandmother, who passed long ago, into my visualizations. Soon other long-gone relatives arrived. Of particular interest was my Aunt Grace, who continues to lead my healing rituals. Grace died a couple decades before I was born, but I’ve always felt a bond so close, I’ve dedicated my life work to her. She is my guide and my angel.

I now understand that our connection comes from sharing similar traumas. We were both the “fixers” of impossibly broken families and both got profoundly ill at 21. Tragically, Grace died from leukemia. Mine was a different death when CRPS ravaged my body.

Through arduous work and by facing hard truths, I now see that, like Grace, most of my ancestors suffered profound trauma, and by sharing their genes, I’ve inherited the injury that binds me to disease. Science calls this epigenetics.

By healing the wounds of my ancestors through rituals, I’m healing myself. Additionally, I’m breaking cyclical familial patterns by not passing along the burden of traumatic energy to those I engage with.

These seemingly “woo woo” rituals appeared novel – hell, I thought I’d invented a breakthrough therapy! That was until I described them to an integrative trauma expert who shared that “Ancestral Healing” is a real thing, scientifically proven and all.

Life is precious. So is our life preserving, life enhancing peace. Whether I’m on my way out now or have 30 more years of kick in me, I’m focusing on protecting this essential resource. 

I’m convinced that most of our pain, physical and emotional, springs from inner tumult driven by deep wounds, many of them handed down. Through intentional work and practice, we can quell that upset and find peace. Then the challenge is to hold our peace sacred, to protect it from internal and external “vampires” that aim to trip it up.

My mom turned 90 last month and is suffering from advanced Alzheimer’s, I believe brought on by trauma. That trauma has passed down to me, seeding a lifetime of illness.

I recently spent time with Mom at her new memory center, and later that day delighted in meeting my newest grand-niece named after this beautiful, generous and loving woman.

I hope that by healing the wounds our ancestors couldn’t, I’ll help this li’l darling have a pain-free, peace-filled life, one she can, in turn, hand down.            

Cynthia Toussaint is the founder and spokesperson at For Grace, a non-profit dedicated to bettering the lives of women in pain. She has lived with Complex Regional Pain Syndrome (CRPS) and 19 co-morbidities for 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.”

Nearly Half of Adults Think U.S. Healthcare System Is Failing

By Pat Anson, PNN Editor

Almost half of American adults (44%) give the U.S. healthcare system poor or failing grades, according to a new Gallup survey that found most respondents concerned about rising medical costs and growing healthcare inequality. Overall, the healthcare system was given a barely passing grade of C-minus.

"After years of higher prices, growing inequities, skipping treatments, getting sicker, or borrowing money to pay medical bills, it's no wonder so many Americans view the health system so poorly," said Timothy Lash, President of West Health, a group of healthcare non-profits that commissioned the survey.

The survey of nearly 5,600 Americans in all 50 states was conducted in June, with a nationally representative sample reflecting racial and ethnic backgrounds.

The worst overall grade on the healthcare report card – a D-minus – was given to the cost of care. One in four adults (26%) did not seek treatment due to cost in the last three months; while one in three (35%) are concerned they will be unable to afford healthcare in the next 12 months.  

Healthcare in America Report Card

source: west health-Gallup

The affordability issue is worse for those living with chronic health conditions. About 1 in 5 skipped care to pay for other household expenses, compared to about one in eight of those without chronic conditions.

“When members of my family have needed surgeries or medications [they] have to really consider how much medical debt they’re willing to go into. Our healthcare system forces us to try and make calculations between financial security and health just because of how expensive things are, and that’s even with health insurance, so I can’t imagine if you didn’t have health insurance how fraught that would be,” said survey participant Stef Schloo, 28, who lives in Pennsylvania

“I am single and so all of that falls down on me. And the only thing that would concern me is if I really developed a major health situation or, God forbid, if I was in a major accident or had to have long-term care, that’s a great concern to me,” said Patricia Slough, 67, who lives in Massachusetts.

Quality of care was the only aspect of the healthcare system that received more positive than negative marks, although it was still only able to earn an overall grade of C-plus. Women were less likely to give good grades for quality than men (38% vs. 57%); and Black and Hispanic Americans were also less likely to give a good grade for quality than the general population (36% each vs. 47%).

“You can have some of the best doctors in the world practicing here. I’m not saying that other countries don’t have great doctors, but I think our healthcare professionals can be second to none depending on where you go in America,” said Andrew Kerner, 30, who lives in North Carolina.

Healthcare Access and Equity

The grades for access to care and equitable care also broke down along racial lines. Two-thirds of Black Americans (66%) and Asian Americans (64%) selected a grade of D or F for health equity, which is the ability of every person to get quality care regardless of race and ethnicity. By comparison, Hispanic Americans (55%) and White Americans (53%) gave a poor or failing grade to equity,

Women, Blacks, Hispanics and Asian Americans were also more critical when it came to access to care. More than 40% in each of these groups gave access D’s and F’s, compared to about a third of White Americans and men.

“For the richest country on earth I think we have the most deplorable healthcare system... due to its inequity, mainly due to the way it all depends on how much money somebody has whether they get good healthcare or not,” said Anne Courtney Davis, 71, who lives in Ohio.

The survey also found that most younger and middle-aged adults are worried that Medicare and Social Security will not be available to them when they become eligible. That sentiment cuts across political lines, with 71% of Democrats, 66% of independents and 62% of Republicans worried or extremely worried about not having access to Medicare. When it comes to Social Security, there is even more agreement — 77% of Democrats, 75% of independents and 73% of Republicans are worried it won’t be there for them when they grow older.

Under an 11-point plan by Sen. Rick Scott (R-FL), chair of the National Republican Senatorial Committee, funding for Social Security, Medicare and other so-called entitlements would have to be put to a vote in Congress every five years.

“When I witness these individuals say that Medicare should be renewed every five years, it kind of makes me nervous [it’s] not going to be there for individuals when we get older,” said Nick Lembo, 27, of Indiana. “That’s startling to me because you should want to take care of those who are older than you because eventually... you’re going to be at that age.”

Biden Pardons Thousands Convicted of Marijuana Possession

By Pat Anson, PNN Editor

President Joe Biden is pardoning everyone who has been convicted of simple marijuana possession under federal law and is urging governors to take similar action for those convicted of possession under state laws.

Biden’s blanket pardon will affect over 6,500 people who have been convicted or charged with federal offenses for marijuana possession. If governors join in, it could potentially impact millions of others who have been convicted of possession under state laws and now have criminal records. The pardon does not alter federal or state laws that prohibit marijuana trafficking, marketing and under-age sales.

“Sending people to prison for possessing marijuana has upended too many lives and incarcerated people for conduct that many states no longer prohibit. Criminal records for marijuana possession have also imposed needless barriers to employment, housing, and educational opportunities,” Biden said in a statement. “Just as no one should be in a Federal prison solely due to the possession of marijuana, no one should be in a local jail or state prison for that reason, either.” 

The mass pardon partially fulfills a campaign promise made by Biden during the 2020 election campaign and begins the process of changing marijuana’s status under federal law. Biden said he would ask Attorney General Merrick Garland to “expeditiously” review how marijuana is classified.

Marijuana was classified by the DEA as a Schedule I controlled drug in 1970, on the same level as heroin and LSD, which means it has “no currently accepted medical use.” That classification now makes little sense, with 37 states and the District of Columbia having legalized medical marijuana as a treatment for chronic pain and other health issues.

“We are pleased that today President Biden is following through on this pledge and that he is also encouraging governors to take similar steps to ensure that the tens of millions of Americans with state-level convictions for past marijuana crimes can finally move forward with their lives,” said Erik Altieri, Executive Director of the National Organization for the Reform of Marijuana Laws (NORML).  

Altieri said the DEA should “deschedule” marijuana under the Controlled Substances Act, and not just change its status to a less restrictive Schedule II or III level. Descheduling would amount to full legalization.

“Nearly half of voters now agree that legalizing marijuana ought to be a priority of Congress, and such action can only be taken by descheduling cannabis and repealing it from the US Controlled Substances Act — thereby regulating it in a manner similar to alcohol,” he said.

In 2020, the House passed legislation to decriminalize marijuana at the federal level, but the bill never came to a vote in the Senate, then controlled by Republicans. Legalization would appear unlikely if the 2022 midterm elections result in the GOP taking control of either the House or Senate.

Last week, a House GOP caucus released a “Family Policy Agenda” saying Congress should not legalize marijuana. The report claimed legalization at the state level “led to an explosion of marijuana use among children, which is having a hugely negative impact on their health.”

More Americans are now using marijuana and cannabis-based products to manage their pain than pharmaceutical drugs. A 2021 Harris Poll found that 16% of adults are using cannabis or CBD for pain relief, compared to 8% who use opioid medications and 11% who use non-opioid pain relievers.

Study Finds Non-Opioid Pain Relievers Effective for Arthroscopic Surgery

By Pat Anson, PNN Editor

Patients recovering from minimally invasive shoulder or knee surgery do just as well with non-opioid pain relievers as those who use opioids, according to a new study at McMaster University and Hamilton Health Sciences (HHS) in Canada.

The study, published by the Journal of the American Medical Association (JAMA), looked at 193 outpatients who had arthroscopic surgeries on their knees or shoulders at three hospitals in Hamilton, Ontario.

About half received standard care with opioids for postoperative pain, while the other half received naproxen and acetaminophen for pain, as well as pantoprazole, a medication normally used to treat heartburn and acid reflux. An emergency supply of opioids was available to both groups, if needed, for additional pain relief.

After six weeks, patients in the opioid group had used an average of 72.6 mg of opioids, compared to 8.4 mg in the opioid-sparing group. Two patients in the opioid-sparing group asked for opioid medication after discharge. Researchers say there were no significant differences in pain levels, patient satisfaction or adverse events between the two groups. 

“This study clearly shows that many of these surgical patients can be treated safely without opioid medications in a select population,” said lead author Olufemi Ayeni, MD, a professor of surgery at McMaster and an orthopedic surgeon at HHS. “Furthermore, by reducing the number of opioids prescribed, we can collectively reduce the development of a reservoir of unused medications that can cause harm to many in society.” 

Over the past decade, the number of arthroscopic surgeries has soared in North America. About one million arthroscopies are performed annually in the United States and 100,000 in Canada. Several studies, however, have that found arthroscopic surgeries provide only temporary relief from knee pain and do not improve function long term.

To be clear, there is no comparison between arthroscopies and highly invasive surgical procedures such as heart bypass surgery.  Arthroscopies are a type of “keyhole” surgery in which the surgeon makes a small incision and inserts a tiny camera and instruments to diagnose and repair damaged ligaments or joints. The procedure often takes less than an hour and patients are sent home the same day — so there is less need for pain medication.

A recent analysis of nearly half a million minimally invasive surgeries in the U.S. found that the number of opioid pills prescribed to patients fell by 50% since 2017. Hospitals are increasingly using acetaminophen, non-steroidal anti-inflammatory drugs (NSAIDs), gabapentinoids and other non-opioids for post-operative pain.  

Most Americans are more worried about treating post-operative pain than they are about becoming addicted to opioids. A 2021 Harris poll found that nearly 8 out of 10 U.S. adults believe opioids are sometimes necessary to manage pain after surgery and 60% prefer opioids over OTC pain relievers.

Why Troches Make Medications More Effective

By Dr. Forest Tennant, PNN Columnist

We regularly get emails from people who have gastrointestinal problems or tell us a particular medication is ineffective for them.  Pills and other oral medications are not always the best way to treat Adhesive Arachnoiditis (AA) or its related diseases.

The problem is that the stomach, intestine and liver don’t assimilate and metabolize more than 30 to 50 percent of the swallowed oral dose. Oral medications may also cause gastric irritation or even bleeding, and the drug may require an hour or more to be effective. Persons with AA and Ehlers-Danlos Syndrome (EDS) may have gastrointestinal dysfunction, which can make some oral medications like opioids almost totally ineffective.

If you are experiencing gastrointestinal problems or believe some of your medications are ineffective, we suggest you try using troches (the Greek pronunciation is “tro-key”). Troches are essentially lozenges that contain medication. They are placed in the mouth between the tongue and cheek until the medication dissolves.

The ancient Egyptians made some of the first troches from honey, herbs and spices to treat sore throats. Medicines introduced into the body this way bypass the digestive system and deliver their active ingredients directly into the blood stream through blood vessels under the tongue and in the cheek.

Superior Traits of Troches

Troches are a superior way to administer many of the key medications and hormones required to treat AA, and its related problems of Tarlov cysts and EDS. Some of these medications, like ketamine and oxytocin, are essentially ineffective if swallowed. 

  • More potent than swallowed medication 

  • Fast acting – within 10 minutes 

  • No direct gastrointestinal irritation 

  • Can reduce reliance on opioids 

  • Avoids injections and suppositories

A troche must be compounded by your local pharmacy.  Every community today has pharmacies that will make or “compound” troches. For better pain relief and control of AA, Tarlov cysts and EDS, we highly recommend that patients and medical practitioners take the advanced step in therapeutics and begin to use troches. 

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 a 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.   

New Treatment Offers Hope for Lupus Patients

By Dr. Eric Morand, Monash University, Australia

When real patients have unprecedented positive outcomes to a new treatment, it’s tempting to talk about it as “breakthrough” for medical science. This describes the excitement around a new report from researchers in Germany of a radical new treatment for lupus.

The patients in the study – five people with severe lupus – went into remission following pioneering CAR T-cell treatment, which uses genetically altered cells.

What is lupus, why is this such big news, and what could it mean for other patients and diseases?

Around 5 million people are affected by some form of lupus worldwide. The most common form of lupus is technically known as systemic lupus erythematosus. Though not widespread, it is more common than multiple sclerosis (MS). Both are “autoimmune” diseases where the immune system attacks its owner instead of the germs it is supposed to fight.

MS is an autoimmune disease where the immune system attacks nerve tissue. In contrast, lupus can affect any organ in the body. Treatments for lupus have been so poor for so long that even wealthy and famous people with the disease – like pop star and actor Selena Gomez – have had organ failure resulting in the need for a kidney transplant. A lot of complicating factors have made it hard to improve outcomes for people with the disease.

Firstly, the variety of tissues lupus can affect means no two patients are exactly alike. Diagnosis is hard and often delayed. This also means we researchers have to deal with a lot of complexity as we try to work out what is causing the disease. This clinical variability makes measuring improvement in response to treatment difficult, and many clinical trials have likely failed due to measurement issues.

Second, there is variation between patients in which part of the immune system goes wrong. This means different patients will need different treatments – and we still do not know with certainty how to get this right. But progress is happening fast.

Innate and Adaptive Immunity

The immune system is in two parts, innate and adaptive.

The “innate” immune system responds fast but non-specifically to viruses and other germs that hit the body with a slug of germ-killing inflammatory proteins. The “adaptive” immune system is slower but more precise. It swings into action after the innate immune system and provides long lasting defense against the invading germ.

When you are vaccinated against a disease (such as COVID), the fever and aches you might get in the first day or two is your innate immune system at work. But the long-lasting protection from antibodies is provided by a part of your adaptive immune system, a key part of which is delivered by cells called “B cells”.

In lupus, both parts of the immune system are involved, and both have been successfully used to develop medicines. Earlier this year, the Therapeutic Goods Administration approved anifrolumab, a drug which blocks “interferon”, a crucial protein made by the innate immune system.

Another drug which works on B cells of the adaptive immune system, called belimumab, was approved a few years ago. Unfortunately, neither drug is on Australia’s Pharmaceutical Benefits Scheme yet, so access is extremely limited.

However, we now know that interferon and B cells are both important, and so very strong treatments that almost completely eradicate either could be useful. That is where this potential new treatment comes in.

Already Used to Treat Cancer

Treatments to destroy B cells are used in cancers like lymphoma. The most powerful of these uses CAR-T cells, which train a type of natural cell to be an assassin of the B cell.

CAR-T medicines are highly complex to make, and extremely expensive – but they work.

T cells are collected from the blood, then re-engineered in a special laboratory.

Now, this new report shows targeting B cells using this approach could be effective in lupus too. Building on a first-ever patient treated in this way by the same group a year ago, doctors in Germany created a “homemade” CAR-T treatment and used it in five patients with severe lupus.

Remarkably, all five patients had near complete eradication of disease, allowing them to stop conventional medicines, like steroids, with potentially harmful side effects.

What This Means for Other Patients

So what does it mean for patients in Australia? Well, most centres aren’t able to make their own CAR-T treatments, so delivering this potential treatment will require a commercial approach.

However, it might be quicker to market than other treatments in development as it takes a proven approach into a new disease, rather than being new from the ground up.

One day we might even be able to extend such treatments to other autoimmune diseases, like MS, where B cell-directed treatments have been helpful, as well as in lupus.

This would need to be balanced against risk. Importantly, short term side effects of CAR-T treatment (which include brain and bone marrow problems) can be severe. For this reason, such a treatment would only be used for the most severe cases in which standard treatments have failed, like the patients in the German trial.

Long-term side effects are also unknown at this time, and of course suppressing the immune system so profoundly in the setting of a pandemic is not without major risks.

Formal trials of a commercial CAR-T medicine for lupus are in the advanced planning stages already, and Australia is likely to be front and centre of these due to our lupus expertise and trial-friendly regulatory environment. With all these advances, we can at last tell our patients, and our friends and family with lupus, that there is light at the end of what has been a very long tunnel.

Eric Morand, MD, is a clinical rheumatologist and Head of the School of Clinical Sciences at Monash Health, Monash University in Australia.  Dr. Morand consults with companies involved in lupus drug development, including Novartis and AstraZeneca. He receives funding from Australia’s National Health and Medical Research Council and Lupus Research Alliance US, and is a Director of Rare Voices Australia.

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

The Conversation