A Weird Trick to Get Doctors to Listen to You

By Crystal Lindell, PNN Columnist

There’s a lot of advice out there on how to get a doctor to take you seriously. Most of it is wrong.

Lucky for you, I’ve been in pain for a decade! Through trial and lots of errors, I’ve learned a few things and I’m happy to share them with you.  

First though, a little background on why you might need this information. It’s basically a rite of passage for chronically ill patients to lose their faith in doctors. We go in expecting Dr. Gregory House – the brilliant and grumpy lead character on the TV show House -- to solve the puzzle of our illness. Instead, we’re more likely to be met by a doctor with all of House’s hostility, but none of his determination.  

Doctors are notorious for downplaying symptoms, ignoring concerns, and blaming everything on the patient’s weight/smoking habit/stress/drug-seeking behavior.

They also tend to have a violent aversion to patients who suggest their own diagnoses. Their delicate doctor egos override any rational reaction and, more often than not, patients with chronic illness leave their appointments with no answers.

I used to think this only happened to women, but after attending multiple appointments with men in my family, I have come to realize that it’s just an across-the-board thing. My theory is that many of them became doctors so they can be seen as the smartest person in the room. And they hate it when patients treat them as equals, instead of the superior beings they believe themselves to be.

The problem is, a lot of patients tend to be really good at figuring out what’s wrong with their own bodies. They’re highly motivated to find answers, and they have more access to medical research tools then ever before in human history. Doctors love to mock Dr. Google, but that’s kind of like mocking libraries. Finding information online doesn’t automatically make it less valuable than finding it in a book.

Which brings us to the problem: Once we, as patients, figure out what might be wrong, how do we bring it up to our doctor without offending them?  

In short, it’s all about framing. You need to suggest that someone else is making you ask them about whatever it is you want to bring up. Let me share an example:

Do NOT say: “I think I have Ehlers-Danlos Syndrome.”

Instead, say: “My best friend wanted me to ask you about something. I don’t even think it’s a thing, but she thinks I might have something called EDS. Ehlers-Danlos syndrome, I think? I don’t know. It’s probably rare. But have you heard of it? Do you think I might have it?”

Here’s another example:

Do NOT say: “I think I have ADHD.”

Instead, say: “So my wife said I had to ask you about something. I don’t know if she’s right, but if I don’t bring it up with you, she’ll be really mad at me. She thinks I might have something called attention deficit disorder. And she said you might be able to help.”

Yes, I know, it’s annoying and demeaning. And you’re right, patients shouldn’t have to navigate medical conversations like this. They shouldn’t need to fake ignorance to get a doctor to help them.

But this column isn’t about overturning medical power structures. It’s about getting immediate results in what are often life-threatening situations. And I can assure you, this method works. I speak from experience. It is literally how I got my EDS diagnosis after dealing with chronic pain for years. I have shared this tip with others who have also used it successfully.

It works on every type of doctor, too. This is what you say to them:

To ER doctors: “My husband made me come here to get this chest pain checked out.”

To primary care physicians: “My roommate said I had to ask you about having my thyroid levels checked.”

To pain specialists: “My brother thinks I have rheumatoid arthritis and he wanted me to ask you about it.”

To psychiatrists: “My aunt said I should ask you about anxiety medications.”

This will not only help in getting them to take your symptoms seriously, it will also work on convincing them to order specific tests, offer specific medications, and consider a specific diagnosis.

This approach shifts the focus onto a third party, which helps doctors lower their defenses. If they think medical suggestions from patients are inane, you’re just feigning agreement with them. It effectively puts you on the same side as the doctor ⁠— the two of you against your loved one. Which is fine, because your loved one isn’t relying on them for medical care, so they can take the heat. And when the doctor feels like they’re on your side, they’re more likely to want to help.

This approach also means that the doctor knows you are likely to tell a third party what transpired during the appointment, which means they’ll be held to a higher level of accountability. That alone will often have a big impact on how they treat you.

Yes, it is wrong that patients have to use passive aggressive techniques just to get an MRI. But, as my mom always says, it’s better to be wrong than to be dead right. Sure you could insist on being more direct with your doctor, but if that doesn’t work — and the doctor dismisses your symptoms when they should be treating them — the choice could literally leave you dead. You’d be right, but you’d be dead right.

Hopefully, one day, patients won’t have to navigate their doctor’s fragile egos to get the care that they need. Until that day though, this will help. So go forth and be well. And if you can’t be well, at least be well prepared.

Crystal Lindell is a freelance writer who lives in Illinois. After five years of unexplained rib pain, Crystal was finally diagnosed with hypermobile Ehlers-Danlos syndrome. She and her fiancé have 3 cats: Princess Dee, Basil, and Goose. She enjoys the Marvel Cinematic Universe, Taylor Swift Easter eggs, and playing the daily word game Semantle. 

CDC Revises Opioid Guideline, But Can It Undo the Damage to Pain Care?

By Pat Anson, PNN Editor

The Centers for Disease Control and Prevention has released a long-awaited final update to its controversial opioid prescribing guideline, expanding the recommendations to include patients suffering from short and long-term pain, while at the same time giving doctors more flexibility when prescribing opioids.

Although voluntary and only intended for primary care providers treating chronic pain, the original 2016 guideline was adopted as a mandatory opioid policy by many states, insurers, medical societies and even law enforcement agencies, resulting in millions of patients being reduced to lower ineffective doses or taken off opioids and forced into withdrawal. The newly revised guideline is intended to end the “one-size-fits-all” approach to pain care and a public health experiment gone wrong.

“Fundamentally, the framing of the guideline is that pain happens in many different ways, in different intensities, and patients respond to different treatments in different ways. And so it is paramount that clinical decisions are based on the individual needs of the patient,” said Christopher Jones, PharmD, Acting Director of CDC’s National Center for Injury Prevention and Control and a guideline co-author.

“In some cases opioids, even opioids at high doses, are the right thing to do for the patient. It’s more about working with the patient to set expectations and goals and look at the full range of treatments. And if opioids are the right thing or opioids plus non-pharmacological treatments, or opioids plus NSAIDs, if that’s the right thing and the patient is doing well and meeting their goals, this guideline supports that. It doesn’t dictate any particular type of care that any particular patient has to receive.”

Benefits vs Risks

To be clear, the revised guideline still takes a dim view of opioid pain medication and its potential to result in addiction and overdose. Doctors are advised to “maximize” the use of non-opioid drugs and non-pharmacological treatments, and should “only consider initiating opioid therapy if expected benefits for pain and function are anticipated to outweigh risks to the patient.” When opioids are prescribed, it should be at the “lowest possible effective dose.”   

Other notable changes in the guideline:

• A more cautious, slower approach to opioid tapering that strongly encourages patient buy-in before doses are reduced

• Drug testing only recommended when “appropriate.” Doctors should first “consider the benefits and risks of toxicology tests”

• Instead of “extreme” caution about taking opioids with benzodiazepines and other anti-anxiety drugs, “particular” caution is recommended

• Patients should not be dismissed for failing a drug test or because of information found in prescription drug databases (PDMPs)

Importantly, the revised guideline also removes a recommendation in the 2016 guideline that daily opioid doses not exceed 90 MME (morphine milligram equivalents), which was widely seen as a hard limit. It is replaced with cautionary language about doses above 50 MME being “more likely to yield diminishing returns.”  

“There are tweaks, but I think they are tweaks that are meaningful. That doesn’t mean its not still built on a rotten core,” says Kate Nicholson, Executive Director of the National Pain Advocacy Center (NPAC), who belonged to an independent advisory panel that advised the CDC to drop all references to MME.

Nicholson is concerned the 50 MME threshold – which is mentioned two dozen times in the revised guideline – will be misapplied as the new hard limit.

“They still overly focus on MME’s,” she told PNN. “They do qualify it whenever they mention it, but it’s still there, it’s there a lot, and it’s aligned strongly with risk. My concerns are misapplication, even though they say repeatedly ‘Do not apply this as a strict threshold.’”

Nicholson is also concerned about the guideline’s expansion beyond chronic pain (pain lasting three months or more) to include people with short-term acute pain from trauma or surgery, as well as “sub-acute” pain lasting one to three months.

“It’s good to cover all pain and not just single out chronic pain. So in theory I think it’s fine, but in practice, given that they acknowledge again and again the problems of the 2016 guideline. Usually, you check your safety features on the airplane before you expand the fleet. And they didn’t. They did it all at once,” she said. “I also have concerns that it’s a clinical practice guideline written mostly by non-clinicians and by people who are not experts in pain. And it’s now going to cover how all pain should be treated?”

For some patient advocates, no amount of revisions are acceptable. They want the CDC guideline revoked.

“False claims of one-size-fits-all dose thresholds are alive and well in this final draft. More than ever, I am convinced that the CDC must be restricted by law from issuing practice guidelines of this type,” says patient advocate Richard “Red” Lawhern. “It doubles down on lies and cherry-picked research intended to further suppress opioid prescribing at the expense of undertreating patients and driving clinicians out of pain management practice.”

Most of the mainstream media coverage of the revised guideline portrayed it as a weaker or softened version of the 2016 guideline. That is puzzling to Andrew Kolodny, MD, founder and president of the anti-opioid activist group Physicians for Responsible Opioid Prescribing (PROP), who believes the new guideline is “much stronger” than the original.

“Press coverage of the CDC opioid guideline is wacky,” Kolodny wrote on Twitter. “CDC issued a guideline much stronger than the 2016 version (high dose defined as 50 MME/day instead of 90) but press headlines say CDC softened guideline.”

Reversing the Damage

Many patient advocates believe it will be hard to unwind the damage caused by the 2016 guideline to patients, pain management practices, and the healthcare system in general.

“Many laws, regulations, and policies were implemented from the rigid application of the 2016 opioid dosage thresholds. I believe this means many physicians may remain reluctant to prescribe opioids when indicated for chronic pain, and patients may continue to find access to treatment a challenge,” said Dr. Lynn Webster, Senior Fellow at the Center for U.S. Policy and past president of the American Academy of Pain Medicine

“To reverse the damage, the CDC could take an active and vocal public role in publicizing the statements about the guideline not being a law, regulation or policy. The agency should make sure that governmental and enforcement entities know there’s a new CDC statement on these matters.”

Chris Jones said the CDC would monitor how the revised guideline is implemented by states, insurers and others to prevent further misapplication. But he was vague about how it would be done, saying it needs to be handled on a case-by-case basis and while recognizing that “states do what states do.” The CDC has no legal authority to enforce its recommendations.

 “As with any clinical practice guideline, the work doesn’t stop today. It really starts as we engage with the clinical community, as we engage with patient organizations with educational opportunities. Certainly engaging with insurers and others to say, ‘Here’s the latest evidence about the range of treatment options that can be effective,’” he told PNN. “But we’re still working through, from a policy perspective when we see misapplication, how to respond to that.”

Jones said he would be speaking next month to the National Conference of State Legislatures about the revised guideline and to reinforce the need for individualized patient care. He and the other guideline co-authors also published an op/od in The New England Journal of Medicine that cautions providers about misapplying the CDC’s recommendations.

Webster thinks the CDC’s efforts to combat addiction and overdoses should be refocused on illicit fentanyl and other street drugs, which are involved in the vast majority of drugs deaths. In 2021, nearly 108,000 Americans died from overdoses, a record number.

“I think it is important to remember that the goal of the guideline was to reduce the number of overdose deaths by reducing the opioid supply or amount prescribed. It hasn’t worked out that way,” Webster said. “Over the past decade, opioid prescribing has plummeted, but the number of overdoses has skyrocketed. The CDC should now focus on the cause of most opioid-related overdose deaths, which is to bring attention to the social and economic factors that create the demand for so many Americans to escape the pain of living.” 

Study Finds Harmful Effects of Chronic Pain Persist Throughout Life

By Pat Anson, PNN Editor

If you have chronic pain in middle age, chances are you will continue to have pain and poor overall health as you enter your senior years, according to a large new study in the UK that found pain has wide-ranging effects throughout life. Pain sufferers are significantly more likely to be unhappy, depressed and unemployed as they grow older.  

Researchers followed the health data and survey responses of over 12,000 people who were born in England, Scotland and Wales in March 1958. The study began in 2003, when most of the respondents were age 44, and continued until they turned 62 in 2021

The research findings, published in PLOS ONE, show that pain can persist for decades and may even be passed from one generation to the next.

“Tracking a birth cohort across their life-course we find chronic pain is highly persistent. It is associated with poor mental health outcomes later in life including depression, as well as leading to poorer general health and joblessness. We hope the study highlights the need for academics and policy makers to focus more attention on the problems of chronic pain,” wrote lead author Alex Bryson, PhD, a Research Fellow at University College London.

Bryson and his colleagues found that two-fifths of respondents reported suffering from chronic pain in their 40’s. Of those, 84% still reported “very severe” pain at age 50. Having chronic pain at 44 was also associated with poor mental health, lower life satisfaction, pessimism about the future, poor sleep and joblessness at age 55.

In the last year of their study, researchers found that having pain at midlife also raises the risk of a covid infection at age 62, a finding that supports previous studies showing that people in poor health are more susceptible to Covid-19.

The study pinpointed several factors that predict pain at a later age, including a father’s social and economic status. Respondents whose fathers were professionals, managers or administrators when they were born were significantly less likely to report chronic pain 44 years later.

The UK study reached many of the same conclusions as U.S. researchers, who have found that less-educated, working class Americans have higher rates of pain, social isolation, drug abuse, disability and suicide than those with college degrees. Efforts at treating physical pain, either with opioids or non-opioid therapies, have failed to turn the tide.  

“Our evidence on the persistence of pain across the life-course suggests efforts to counter it have not been wholly successful,” said Bryson. “We have shown that it is, in part, passed from one generation to the next, with those from lower social classes suffering most. Pain appears to be another source of inter-generational disadvantage, and one that is potentially as problematic as other aspects of social deprivation.”

FDA Warns Amazon and Walmart About Selling Misbranded Drugs

By Pat Anson, PNN Editor

The U.S. Food and Drug Administration has issued another warning to consumers not to purchase or use dietary supplements marketed for pain relief under the brand names “Artri” or “Ortiga” due to potentially dangerous pharmaceutical ingredients. Use of the products has led to liver toxicity and at least one death, according to the agency.

The FDA issued its first first warning about the supplements in January and followed up with a second warning  in April. The latest warning includes Amazon, Walmart and another retailer that continued to sell the supplements, which are marketed with claims that they treat arthritis and osteoarthritis, restore cartilage, and stop joint deterioration.

In a warning letter sent to Amazon last week, the FDA said it had purchased Artri and Ortiga supplements through its website and had them delivered through the company’s delivery service.

Laboratory testing confirmed the supplements purchased through Amazon contained diclofenac, a non-steroidal anti-inflammatory drug (NSAID), and dexamethasone, a corticosteroid used to treat inflammatory conditions.

Neither drug is mentioned on product labels, which list ingredients such as glucosamine and turmeric. The FDA warned Amazon that introducing or delivering a misbranded drug is a violation of federal law.  

“Failure to adequately address this matter may result in legal action including, without limitation, seizure and/or injunction. Please submit a written response to this letter within fifteen working days from the date of receipt, explaining the specific steps you have taken to address any violations,” the FDA letter states.

Similar warning letters were sent to Walmart and Latin Foods Market, which had previously issued voluntary recalls for the supplements, but still continued to sell them.

It appears the Artri and Ortiga supplements have now been removed from the websites of all three companies. The supplements were being marketed primarily to Spanish-speaking consumers, with claims they are “highly effective in restoring cartilage” and “fights arthritis.”  

Diclofenac raises the risk of cardiovascular events, such as heart attack and stroke, as well as serious gastrointestinal bleeding and damage. When used long term or in high doses, dexamethasone and other corticosteroids can result in serious withdrawal symptoms if a consumer suddenly stops taking them. Both drugs can also interact with other medications.

The FDA encourages healthcare providers and patients to report side effects involving use of the products to its Adverse Event Reporting System. .

Smoking Marijuana More Effective Than CBD Extracts for Back Pain

By Pat Anson, PNN Editor

One of the reasons many medical marijuana users prefer edibles over smoking is that they are perceived as healthier.  Marijuana smoke contains many of the same chemicals and carcinogens as cigarette smoke, and could have harmful effects on people with respiratory or cardiovascular problems.

But a small new study conducted in Israel found that smoking marijuana is better than ingesting it, at least when it comes to treating chronic lower back pain. Researchers enrolled 24 adults with MRI or CT scans that showed evidence of disc herniation or spinal stenosis, and had them try two different types of cannabis treatment.

The first was a cannabis extract rich in cannabidiol (CBD), which was taken sublingually under the tongue daily for 10 months. After a month of no treatment, the same group smoked cannabis flowers rich in tetrahydrocannabinol (THC) up to four times a day for 12 months. Participants were allowed to take pain medication as needed, including oxycodone and acetaminophen.

The study findings, published in the Rambam Maimonides Medical Journal, showed there was little to no improvement in back pain when participants took the extract, but significant improvement when they smoked cannabis. The use of analgesic drugs also dropped significantly while smoking.

Notably, three patients dropped out of the extract phase of the study because it wasn’t helping them, but then returned to participate in the smoking phase.

“The current study is the first, to our knowledge, to indicate that THC-rich smoked therapy is more advantageous in ameliorating LBP (lower back pain), than low THC CBD-rich sublingual extracts. Despite the small number of patients, our data indicate that THC-rich smoked therapy is helpful in mitigating LBP,” researchers reported.

The most commonly reported adverse events during the study were nausea, dizziness, drowsiness and fatigue during the extract phase; sore throat and drowsiness were reported during the smoking phase. All of the adverse symptoms disappeared after a dose tolerance was reached. Most of the adverse effects were in female patients.

A 2019 study of medical marijuana users also found that smoking cannabis provided more pain relief than ingesting it. Over 3,300 people logged their symptoms on a mobile app while using a variety of cannabis products, including dried flower, edibles, tinctures and ointments. Smoking the dried flower provided more pain relief than any other cannabis product, regardless of the amount of THC.

Another problem with CBD edibles is that they are frequently mislabeled. A recent study of 80 CBD oils found that only 43 had concentrations of cannabidiols that were within 10% of their label claims – an accuracy rate of just 54 percent.

Newly Discovered Gut Bacteria Linked to Rheumatoid Arthritis

By Meagan Chriswell, University of Colorado Medicine

Rheumatoid arthritis affects 1 in 100 people worldwide. It causes inflamed, painful and swollen joints, often in the hands and wrists, and can lead to loss of joint function as well as chronic pain and joint deformities and damage. What causes this condition has been unknown.

In our recently published study, my colleagues and I found an important clue to a potential culprit behind this disease: the bacteria in your gut.

Rheumatoid arthritis is an autoimmune condition, meaning it develops when the body’s immune system starts to attack itself. Proteins called antibodies, which usually help fight off viruses and bacteria, begin to attack the joints instead.

The origins of the antibodies that cause rheumatoid arthritis have been an area of study for many years. Some research has shown that these antibodies can start forming at sites like the mouth, lung and intestines over 10 years before symptoms arise. But until now, it was unclear why researchers were finding these antibodies in these particular areas.

We wanted to investigate what could trigger the formation of these antibodies. Specifically, we wondered if bacteria in the microbiome, a community of microorganisms that live in the intestines, might be the ones activating the immune response that leads to rheumatoid arthritis.

Since microbes commonly live at the same sites as the antibodies driving rheumatoid arthritis, we hypothesized that these bacteria could be triggering the production of these antibodies. We reasoned that though these antibodies were meant to attack the bacteria, rheumatoid arthritis develops when they spread beyond the intestines to attack the joints.

First, we sought to identify the intestinal bacteria targeted by these antibodies. To do this, we exposed the bacteria in the feces of a subset of people at risk for developing rheumatoid arthritis to these antibodies, allowing us to isolate just the bacterial species that reacted and bound to the antibodies.

We found that one previously unknown species of bacteria was present in the intestines of around 20% of people who were either diagnosed with rheumatoid arthritis or produce the antibodies that cause the disease.

As a member of the Cherokee Nation of Oklahoma, I suggested we name this species Subdoligranulum didolesgii (“didolesgii” means arthritis or rheumatism in Cherokee) as a nod to the contributions that other Indigenous scholars have made to science as well as the fact that rheumatoid arthritis affects Indigenous people at a higher rate than other populations.

Subdoligranulum didolesgii has not been detected in the feces of healthy people before, and it is currently unknown how prevalent this bacteria is in the general population.

We also found that these bacteria can activate specialized immune cells called T cells in people with rheumatoid arthritis. T cells drive inflammatory responses in the body, and have been linked to the development of different autoimmune diseases.

These findings suggest that these gut bacteria may be activating the immune systems of people with rheumatoid arthritis. But instead of attacking the bacteria, their immune system attacks the joints.

Why This Bacteria?

It is still unknown why people with rheumatoid arthritis develop an immune response to Subdoligranulum didolesgii. But we think it may be the culprit when it comes to rheumatoid arthritis because this bacteria is found only in the intestines of people with rheumatoid arthritis, and not in the intestines of healthy people.

While many immune responses happen in the intestines, they are usually self-contained and do not spread to other areas of the body. However, we believe that a particularly strong intestinal immune response against Subdoligranulum didolesgii could allow antibodies to bypass the intestinal “firewall” and spread to the joints.

To confirm our hypothesis, we gave mice an oral dose of Subdoligranulum didolesgii and monitored their reaction. Within 14 days, the mice began to develop joint swelling and antibodies that attacked their joints.

My colleagues and I hope this research can shed light on the origins of rheumatoid arthritis. Our next goal is to discover how common these bacteria are in the general population and test whether the presence of these bacteria in the gut may lead to the development of rheumatoid arthritis in people.

It’s important to note that antibiotics are unlikely to be helpful treatment for the microbiomes of patients with rheumatoid arthritis. Although Subdoligranulum didolesgii may be triggering an autoimmune response for some people with rheumatoid arthritis, antibiotics eliminate both helpful and harmful bacteria in the gut. Additionally, removing the bacteria won’t necessarily stop the immune system from attacking the joints once it has started.

Nevertheless, we believe that these bacteria can be used as tools to develop treatments for rheumatoid arthritis and hopefully ways to prevent disease from happening in the first place.

Meagan Chriswell is a MD/PhD Candidate in Immunology at the University of Colorado Anschutz Medical Campus. She does not work for, consult, own shares in or receive funding from any company or organization that would benefit from this article.

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

‘Super High Concentration’ of Kratom Involved in Georgia Man’s Death

By Pat Anson, PNN Editor

The family of a 23-year-old Georgia man who died last year after ingesting a potent kratom extract has filed a wrongful death lawsuit against a kratom manufacturer and a trade association that promotes the company for following good manufacturing standards.

Ethan Pope was found dead on the kitchen floor of his apartment on December 3, with his dog by his side. Pope had recently purchased bottles of Black Liquid Kratom made by Optimized Plant Mediated Solutions (OPMS).

An autopsy concluded that Pope died as a result of cardiac arrest due to mitragynine intoxication, and his death was ruled an accident by the Georgia Bureau of Investigation.

Mitragynine is an alkaloid and one of the active ingredients in kratom, which comes from the leaves of a tree that grows in Southeast Asia, where it has been used for centuries as a natural stimulant and pain reliever.

ETHAN POPE

In recent years, kratom has become a popular supplement in the United States, where it is used by millions of people to self-treat their pain, anxiety, depression and substance use problems. It is sold legally in most states, including Georgia, where it can be purchased at gas stations and smoke shops.

Kratom is normally consumed as a dry unadulterated powder, but the Black Liquid Kratom allegedly consumed by Pope is a highly concentrated 50:1 extract, with up to 375mg mitragynine per bottle.

“This super high concentration can be felt with just a drop or two of the extract added to your tea or coffee. Even veteran users of kratom should start slow with this liquid extract because it is so different from other liquid extracts on the market,” is how one kratom vendor markets Black Liquid Kratom.

Another kratom vendor specifically cautions that OPMS extracts are “too strong for use on a daily basis.”

It’s not clear how long, how often or why Pope had been taking kratom, but at a news conference this week his parents said they found a to-do list in his apartment that included the words “Stop taking kratom.”

The family’s lawsuit was originally filed in May and an amended complaint was filed this week, naming over a dozen different individuals, vendors and organizations, including OPMS and the American Kratom Association (AKA).    

“You don’t expect to go into a store and find something similar to heroin between energy drinks and breath mints. We intend to hold every single person and entity involved in the distribution and sale of these products responsible,” attorney Matt Wetherington said in a statement.

The lawsuit drafted by Wetherington makes frequent references to kratom as a heroin-like substance, but there is no relationship between the two. Heroin is derived from opium plants, while kratom comes from mitragynine speciosa trees. Both act on opioid receptors in the brain, however, which has led to claims that kratom is an opioid.

OPMS has not commented publicly on the lawsuit, and the AKA issued a short statement saying it rejected the lawsuit’s claims and filed a motion to be dismissed from the case.

‘100% Natural and Never Adulterated’

OPMS is featured on the AKA’s website as one of the first kratom vendors to comply with its Good Manufacturing Practice Standards Program (GMP), an effort to enhance the safety of kratom products. To get “GMP Qualified” status, vendors have to agree to annual audits, inspections and testing of every production lot of kratom.    

“Optimized Plant Mediated Solutions has been the leader in the Kratom and Kava extract industry since 2010 due to its unique cold water extraction process. All O.P.M.S. products are 100 percent natural and never adulterated,” the AKA says on its website, which includes a link where OPMS products can be purchased directly from the company.

OPMS did not immediately respond to a request for comment from PNN. The company’s website cautions consumers that “several companies illegally counterfeit” its products, adding “dangerous ingredients” that pose a “serious health threat.” It urges consumers to report any suspicious products.

Taken in low doses, kratom acts as a mild analgesic and stimulant. Consumers generally take higher doses to combat severe pain and cravings caused by substance addiction. Most users do not experience a “high” or euphoria after taking kratom.

The Food and Drug Administration has not approved kratom for any medical use and vendors can run into trouble with the agency if they claim kratom can be used to treat health conditions. The FDA tried for years -- unsuccessfully – to schedule kratom as a controlled substance, which would effectively ban its sale and use in the United States. The FDA says kratom’s effects on the brain are similar to morphine and that kratom has “properties that expose users to the risks of addiction, abuse, and dependence.”

Not all federal agencies take such a dim view of kratom. A 2020 study funded by the National Institute on Drug Abuse concluded that kratom is an effective treatment for pain, helps users reduce their use of opioids, and has a low risk of adverse effects.

About 100 deaths have been linked to kratom use, but in the vast majority of cases other drugs and illicit substances were involved.  A toxicology test on Ethan Pope found antihistamine and antidepressant medications in his system, but no illegal drugs or alcohol were detected.

Brain Changes Found in Patients with Long-Term Lyme Disease

By Pat Anson, PNN Editor

Researchers at Johns Hopkins University have documented changes in the brains of patients with post-treatment Lyme disease that may explain symptoms such as brain fog, memory loss and other cognitive issues. The finding could also have implications for patients with long covid, fibromyalgia, multiple sclerosis, chronic fatigue and other health conditions who have cognitive problems.    

Lyme disease is a bacterial illness spread by ticks that causes a rash, flu-like aches and fever, joint pain and fatigue. Most patients fully recover when treated early with antibiotics, but up to 20% of those with post-treatment Lyme disease (PTLD) have long-term symptoms, including depression, insomnia and cognitive difficulties. There is usually no clinical or laboratory evidence to explain their ongoing issues.

“Objective biologic measures of post-treatment Lyme symptoms typically can’t be identified using regular MRIs, CT scans, or blood tests,” says John Aucott, MD., director of the Johns Hopkins Lyme Disease Clinical Research Center.

Aucott and his colleagues recruited 12 PTLD patients and 18 people without a history of Lyme to undergo functional MRI (fMRI) scans while performing a short-term memory task. The scans allow investigators to track blood flow and other changes in the brain in real time.

Their findings, published in the journal PLOS ONE, suggest that cognitive difficulties in PTLD patients are linked to functional and structural changes in the “white matter” of the brain, which is crucial for processing and relaying information. The imaging tests revealed unusual activity in the frontal lobe, an area of the brain responsible for memory recall and concentration. Patients with post-treatment Lyme needed longer periods of time to complete the memory task.

“We saw certain areas in the frontal lobe under-activating and others that were over-activating, which was somewhat expected,” said lead author Cherie Marvel, PhD, an associate professor of neurology at Johns Hopkins.

“However, we didn’t see this same white matter activity in the group without post-treatment Lyme.”

To confirm their finding, researchers used another form of imaging called diffusion tensor imaging (DTI) on all 12 patients with Lyme and 12 of the non-Lyme participants. DTI detects the direction of water movement within brain tissue. Water was diffusing, or leaking, in the the same white matter regions identified in the fMRI.

Researchers believe the increased activity they saw in white matter may reflect an immune system response in the PTLD patients, which may also explain cognitive issues in patients with other chronic health conditions.

PLOS ONE

“Results reported here may have implications for other diseases in which white matter pathology has been demonstrated (e.g., multiple sclerosis) or in illnesses in which cognitive complaints follow disease onset,” researchers said. “The use of multimodal neuroimaging methods, like the ones used in the current study, may be a viable approach for obtaining information on brain function and structure to identify biomarkers of disease burden.”

Researchers say larger studies with more patients will be needed to confirm their findings, as well as long-term tracking of brain changes from the initial Lyme infection through development of PTLD.

Nearly 500,000 people are believed to get Lyme disease each year in the United States. Diagnoses of Lyme have soared over the past 15 years, according to a recent analysis of insurance claims that found Lyme cases rose 357% in rural areas and 65% in urban areas. The highest rates of Lyme were in New Jersey, Vermont, Maine, Rhode Island and Connecticut.

Deaths of Intractable Pain Patients Often Mistaken as Overdoses

By Dr. Forest Tennant, PNN Columnist

Unexpected and sudden death commonly occur in persons who have poorly controlled pain caused by Intractable Pain Syndrome (IPS). Many persons with IPS who have died unexpectedly have been falsely accused of an “overdose” because drugs were found in their body fluids at autopsy. In reality, the cause was almost always cardiac arrest, hypoglycemia or adrenal failure.

Cardiac Arrest

Pain flares during cardiac arrest may cause the adrenal glands to pump out so much adrenalin that their blood pressure and pulse rate jump up dramatically. This causes blood vessels, including the coronary arteries and those in the brain, to constrict and shut off blood flow. The result may be a heart attack, stroke or arrhythmia.

Chronic, recurrent coronary constriction may cause heart pain called “angina.” A person with IPS who has their medications, usually opioids or benzodiazepines, reduced too rapidly is very prone to cardiac arrhythmia and cardiac arrest.

Hypoglycemia

Insulin is normally made and secreted by the pancreas to lower blood sugar in order to digest food and stabilize metabolism. In times of pain, cortisol and blood sugar are raised. When this occurs, insulin is pumped out by the pancreas to heal injured or damaged tissues. Too much insulin caused by a pain flare can force blood sugar to drop to such a low level – a condition known as hypoglycemia -- that death may occur.

The long-term effect of constant pain on the pancreas is an insulin deficiency, so high blood sugar levels (diabetes) are regularly found in persons with IPS.

Adrenal Failure

Uncontrolled constant pain may exhaust the adrenal glands to a point that the hormone cortisol drops too low, causing Addison’s disease or adrenal insufficiency. Symptoms such as darkened skin, abdominal pain and weakness usually appear slowly, but if there’s rapid onset of symptoms it could lead to adrenal failure and death.

Addison’s Disease is named after Dr. Thomas Addison, who described 11 cases of adrenal failure in 1855. About half his cases had histories of severe pain. Persons who die of adrenal failure often do so in their sleep.

Many persons with IPS have unexpectedly and suddenly died and have been falsely accused of drug overdose. To prevent sudden death, persons with IPS must be in a pain treatment program that is balanced and doesn’t rely just on just one or two medications.

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 Intractable Pain Syndrome Research and Education Project.

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

Green Eyeglasses Improve Anxiety and Wellness in Fibromyalgia Patients

By Pat Anson, PNN Editor

Fibromyalgia is well known as one of the most difficult chronic pain conditions to treat. The Food and Drug Administration has approved a handful of medications for fibromyalgia, but many patients find them ineffective in treating the muscles aches, joint pain, fatigue, anxiety and other symptoms that are common in fibromyalgia.  

Researchers at Duke University may have found an easy way to reduce some of those symptoms without the use of drugs. In a small study of fibromyalgia patients being treated with opioids, those who wore eyeglasses with specially tinted green lenses reported a significant improvement in their anxiety and overall sense of wellness. And while their pain levels were unchanged, their use of opioids declined.

“My research has been focused heavily on finding alternatives to opioids for pain management,” says lead author Padma Gulur, MD, Executive Vice Chair of the Department of Anesthesiology at Duke University. “One of the things we discovered early on was that there were visually mediated triggers for pain. We definitely could see that with headaches, but also that it could actually impact pain itself, the pain pathways. While we still don’t fully understand the mechanism of how pathways for pain get activated with visual mediation, it definitely does happen.

“We narrowed it down over some years to the hypothesis that with green light, particularly in the green spectrum, there was an opportunity where it was influencing pain, both chronic pain and acute pain.”

Previous research has found that green light therapy has a calming effect on the brain and is useful in treating fibromyalgia and migraines. But in those studies, participants were confined to a room where they were immersed in green light and told to avoid activities like watching TV or using their cellphones.

Gulur thought there must be an easier way to experience the benefits of green light.

“People want pain relief, but they also want to live their lives. And spending hours and hours in a room or exposure takes away from that quality of life,” she told PNN. “On the other hand, wearing eyeglasses is something we’re all very comfortable doing and, thankfully these days, colored eyeglasses are all the thing.”

Gulur and her colleagues studied 34 fibromyalgia patients who were randomly selected to wear various shades of eyeglasses at least four hours a day for two weeks: 10 patients wore blue eyeglasses, 12 wore clear eyeglasses and 12 wore green eyeglasses.

DUKE UNIVERSITY

Their findings, presented this week at the annual meeting of the American Society of Anesthesiologists, showed that participants who wore green eyeglasses were four times more likely to have reduced anxiety than those in the other two groups, who reported no reduction in anxiety. They also reported feeling better.

“We found that although their pain scores remained the same, those who wore the green eyeglasses used fewer opioids, demonstrating that their pain was adequately controlled,” said Gulur, who noted that patients who wore the green eyeglasses asked if they could keep them at the end of the study.

“They didn’t want to give them back. We had no trouble getting the blue and the clear back, but none of them wanted to return the green glasses.”

Unfortunately, they had to give them back. The eyeglasses are specially formulated to filter a specific wavelength on the green light spectrum and were needed for further study. You can’t buy the glasses online or at your local drug store. At least not yet.

Gulur and her team are planning further studies with green eyeglasses on patients with diabetic neuropathy and chronic back pain.

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.