FDA Head Wants New Regulations for Kratom and CBD

By Pat Anson, PNN Editor

The head of the Food and Drug Administration says his agency will need new authority from Congress to regulate both kratom and cannabidiol (CBD), two natural substances used by millions of Americans to self-treat their pain and other medical conditions.

FDA Commissioner Dr. Robert Califf testified on Thursday before a House Appropriations subcommittee, where he was asked why the agency was slow in developing new regulations for CBD and why it remained opposed to the use of kratom. Califf said new regulatory pathways were needed for both substances because they fall between the cracks of existing law that gives the FDA broad authority to regulate food and drugs.

“I don’t think the current authority we have, on the food side and the drug side, necessarily gives us what we need to have to get the right pathway to move us forward. We’re going to have to come up with something new. I’m very committed to doing that,” said Califf.

Califf was recently confirmed by the U.S. Senate as FDA commissioner, a job he previously held under President Obama. He noted that little progress had been made at the FDA in regulating CBD and other cannabis products since he left the agency.

“You know, when you come six years later to the job you had before and nothing has really changed, that’s telling you that you can’t just keep trying to do the same thing over and over,” said Califf.

Some of the difficulty in regulating CBD comes from passage of the 2018 farm bill, which legalized hemp under federal law. At the time, it was believed that hemp had little or no psychoactive properties and would be relatively harmless. However, as PNN has reported,  some cannabis companies have found ways to concentrate delta-8 tetrahydrocannabinol (delta-8 THC) derived from hemp and are using it in edibles to give consumers a mild intoxicating effect.

The FDA considers delta-8 THC an unapproved drug, but because it comes from hemp – a legal substance – its regulatory status is unclear.

“The amazing plethora of derivatives of the cannabis plant is really quite profound and astounding, and already in widespread use in a variety of means. Most of the FDA effort so far has been spent on research to figure out what the risks, if any, are of various uses of this material in its different forms,” said Califf. “The research so far has shown that there are some risks with CBD. And so, we’re going to need a different pathway than just the standard food pathway.”

FDA Kratom Info ‘Extremely Antiquated’

Califf took a similar stance on kratom, an herbal supplement that 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. An estimated two million Americans use kratom to self-treat their pain, depression, anxiety and addiction — even though the FDA has not approved kratom for any medical condition.

In a recently updated online fact sheet, the agency said 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.”

That brought a rebuke from Rep. Mark Pocan (D-WI), who has supported efforts to keep kratom legal. He called the FDA’s position on kratom “extremely antiquated.”

“That update was not much of an update and I think it’s being very unfair to the consumers who are legally consuming kratom in this country,” Pocan told Califf.  “Honestly, there are not only arguable conclusions (in the update), but you are linking to outdated, incomplete and inaccurate information.“

“I hope to come back to you on kratom in a couple months,” Califf replied. “There are millions of people using kratom. We do have real adverse events, real negative things that have happened to people. And it does interact with multiple neurotransmitters.”

Kratom is banned in several states, but a federal effort to ban kratom nationwide in 2016 failed due to a public outcry. The Department of Health and Human Services (HHS) later withdrew an FDA request to classify kratom as a Schedule I controlled substance, citing lack of evidence it can be abused. A former HHS official said the FDA request to schedule kratom was rejected because of “embarrassingly poor evidence & data.”

Not all federal agencies take such a dim view of kratom. A 2020 study funded by the National Institute on Drug Abuse (NIDA) concluded that kratom is an effective treatment for pain, helps users reduce their use of opioids, and has a low risk of adverse effects. NIDA recently had a public hearing on kratom to further explore its therapeutic uses.

“We’ll continue to work with NIDA and we’ll go where the science takes us,” Califf said. “But like I said with regard to cannabis products, we need something different with these kinds of products that are not traditional foods, not traditional drugs.”

Can ‘Medical Food’ Treat Chronic Pain?

By Pat Anson, PNN Editor

Do you keep a supply of gamma-aminobutyric acid in your medicine cabinet? What about hydroxytryptophan? Or the ominous sounding devil’s claw root?

They’re not exactly household names to the average person, but to Fabio Lanzieri they are essential ingredients in a new “medical food” product called Proleeva, a dietary supplement he developed that contains a blend of a dozen natural herbs, enzymes and amino acids.

“I fervently believe that prescription medications are very beneficial to man, but I also believe that nature does offer us the ability to find solutions to natural diseases. Because of this, I was always interested and read a lot about vitamins, supplements and bioflavonoids,” says Lanzieri, who spent nearly four decades in the pharmaceutical industry. “I believe that supplementing prescription medications with natural substances is the best way of treating chronic pain or any disease state.”

Several years ago, Lanzieri’s wife Maria began experiencing joint pain as a side effect of taking a hormone suppressant to help her recover from breast cancer.     

“I did start feeling the pain in my joints, particularly my fingers. I was having a really hard time sometimes just opening a bottle or doing simple things,” Maria told PNN.

To help his wife, Lanzieri began experimenting with different blends of herbs and other natural substances. Some, like ginseng and curcumin, have been used for centuries as natural remedies for pain and inflammation. Others, like choline bitartrate and L-arginine, have only recently been recognized as essential nutrients that help restore amino acids and neurotransmitters to healthy levels.

You can buy all of these supplements individually, but Lanzieri combined them all into one proprietary formula and gave it to Maria. Her joint pain slowly began to improve.

“After about a month, month and a half, I started having relief of those symptoms.  I didn’t have the joint pain. I felt like I could do a lot of those tasks that I couldn’t do before,” Maria said. “At one point I stopped taking it and it then was all coming back. It was weird. I didn’t think it was the Proleeva. I didn’t associate it with that. But then I went back on it and suddenly I was not feeling it again.”

The Lanzieri’s began sharing Proleeva with family and friends, who also reported positive results.

Only recently have they begun selling Proleeva to the general public on their website and through Amazon, marketing it as “the ultimate comfort food” that “helps bring your nervous system back into balance.”

A Proleeva bottle contains 120 capsules – about a month’s supply – and costs $40.

“I’ve been taking Proleeva for the last seven years and I don’t have any inflammation. I take it because it balances the body with the right ingredients that it needs to fight to heal itself,” says Lanzieri. “Your body needs amino acids and they are not reproduced naturally in the body. And over time, the older we get, the less we have of those amino acids. And therefore, we have to supplement them.”

For now, there is only anecdotal evidence to support these health claims, although a small clinical trial of Proleeva is underway.  Unlike pharmaceuticals, dietary supplements are only loosely regulated by the Food and Drug Administration, allowing supplement makers to introduce new products and make health claims without substantial evidence that they work.

‘One Formulation Makes a Lot of Sense’

Dr. Forest Tennant is intrigued by Proleeva. An expert in treating intractable pain, Tennant recommends that pain patients take gamma-aminobutyric acid (GABA), herbs and other supplements as part of their medical treatment to restore damaged nerve tissue and relieve pain.

“Having a lot of different supplements in one formulation actually makes a lot of sense, because we’re not certain which ones are going to work,” says Tennant. “But I do think there is some urgency or necessity in people with pain taking a variety of these supplements. They can’t hurt themselves and they probably are going to benefit themselves.

“And this particular product is doing something else. It recognizes that it’s got stuff in there like GABA that stimulates the nerve receptors that provide pain relief.”  

Tennant says the supplement industry has become more innovative than the pharmaceutical industry – particularly in an age when opioids and some other medications are harder to get.

“I think the innovation is really great,” Tennant said. “I really think that anyone who has chronic pain, particularly constant pain, really needs to be on a number of supplements right now. We’ll figure out exactly which ones work the best later, but right now I think taking a combination of these things is worthwhile.”

People who try Proleeva or other supplements should not expect instant results. It may take up to a month to feel any benefits.

“The biggest problem is making them stay with this for 30 days. We’re a society of instant gratification. Prescription drugs do that. But unfortunately, natural substances take time,” says Lanzieri.

Long Covid Symptoms Often Overlooked in Seniors

By Judith Graham, Kaiser Health News

Nearly 18 months after getting covid-19 and spending weeks in the hospital, Terry Bell struggles with hanging up his shirts and pants after doing the laundry.

Lifting his clothes, raising his arms or arranging items in his closet leave Bell short of breath and often trigger severe fatigue. He walks with a cane, only short distances. He’s 50 pounds lighter than when the virus struck.

Bell, 70, is among millions of older adults who have grappled with long covid — a population that has received little attention even though research suggests seniors are more likely to develop the poorly understood condition than younger or middle-aged adults.

Long covid refers to ongoing or new health problems that occur at least four weeks after a covid infection, according to the Centers for Disease Control and Prevention. Much about the condition is baffling: There is no diagnostic test to confirm it, no standard definition of the ailment, and no way to predict who will be affected.

Common symptoms, which can last months or years, include fatigue, shortness of breath, an elevated heart rate, muscle and joint pain, sleep disruptions, and problems with attention, concentration, language, and memory — a set of difficulties known as brain fog.

Ongoing inflammation or a dysfunctional immune response may be responsible, along with reservoirs of the virus that remain in the body, small blood clots, or residual damage to the heart, lungs, vascular system, brain, kidneys, or other organs.

Only now is the impact on older adults beginning to be documented. In the largest study of its kind, published recently in the journal BMJ, researchers estimated that 32% of older adults in the U.S. who survived covid infections had symptoms of long covid up to four months after infection — more than double the 14% rate an earlier study found in adults ages 18 to 64. Other studies suggest symptoms can last much longer, for a year or more.

The BMJ study examined more than 87,000 adults 65 and older who had covid infections in 2020, drawing on claims data from UnitedHealth Group’s Medicare Advantage plans. It included symptoms that lasted 21 days or more after an infection, a shorter period than the CDC uses in its long covid definition. The data encompasses both older adults who were hospitalized because of covid (27%) and those who were not (73%).

The higher rate of post-covid symptoms in older adults is likely due to a higher incidence of chronic disease and physical vulnerability in this population — traits that have led to a greater burden of serious illness, hospitalization, and death among seniors throughout the pandemic.

“On average, older adults are less resilient. They don’t have the same ability to bounce back from serious illness,” said Dr. Ken Cohen, a co-author of the study and executive director of translational research for Optum Care, a network of physician practices owned by UnitedHealth Group.

“The challenge is that nonspecific symptoms such as fatigue, weakness, pain, confusion, and increased frailty are things we often see in seriously ill older adults.”

— Dr. Charles Semelka

Applying the study’s findings to the latest data from the CDC suggests that up to 2.5 million older adults may have been affected by long covid. For those individuals, the consequences can be devastating: the onset of disability, the inability to work, reduced ability to carry out activities of daily life, and a lower quality of life.

But in many seniors, long covid is difficult to recognize.

“The challenge is that nonspecific symptoms such as fatigue, weakness, pain, confusion, and increased frailty are things we often see in seriously ill older adults. Or people may think, ‘That’s just part of aging,’” said Dr. Charles Thomas Alexander Semelka, a postdoctoral fellow in geriatric medicine at Wake Forest University.

Ann Morse, 72, of Nashville, Tennessee, was diagnosed with covid in November 2020 and recovered at home after a trip to the emergency room and follow-up home visits from nurses every few days. She soon began having trouble with her memory, attention and speech, as well as sleep problems and severe fatigue. Though she’s improved somewhat, several cognitive issues and fatigue persist to this day.

“What was frustrating was I would tell people my symptoms and they’d say, ‘Oh, we’re like that too,’ as if this was about getting older,” she told me. “And I’m like, but this happened to me suddenly, almost overnight.”

Bell, a singer-songwriter in Nashville, had a hard time getting adequate follow-up attention after spending two weeks in intensive care and an additional five weeks in a nursing home receiving rehabilitation therapy.

“I wasn’t getting answers from my regular doctors about my breathing and other issues. They said take some over-the-counter medications for your sinus and things like that,” he said. Bell said his real recovery began after he was recommended to specialists at Vanderbilt University Medical Center.

Long Covid and Dementia

James Jackson, director of long-term outcomes at Vanderbilt’s Critical Illness, Brain Dysfunction, and Survivorship Center, runs several long covid support groups that Morse and Bell attend and has worked with hundreds of similar patients. He estimates that about a third of those who are older have some degree of cognitive impairment.

“We know there are significant differences between younger and older brains. Younger brains are more plastic and effective at reconstituting, and our younger patients seem able to regain their cognitive functioning more quickly,” he said.

In extreme cases, covid infections can lead to dementia. That may be because older adults who are severely ill with covid are at high risk of developing delirium — an acute and sudden change in mental status — which is associated with the subsequent development of dementia, said Dr. Liron Sinvani, a geriatrician and an assistant professor at Northwell Health’s Feinstein Institutes for Medical Research in Manhasset, New York.

Older patients’ brains also may have been injured from oxygen deprivation or inflammation. Or disease processes that underlie dementia may already have been underway, and a covid infection may serve as a tipping point, hastening the emergence of symptoms.

Research conducted by Sinvani and colleagues, published in March, found that 13% of covid patients who were 65 and older and hospitalized at Northwell Health in March 2020 or April 2020 had evidence of dementia a year later.

Dr. Thomas Gut, associate chair of medicine at Staten Island University Hospital, which opened one of the first long covid clinics in the U.S., observed that becoming ill with covid can push older adults with preexisting conditions such as heart failure or lung disease “over the edge” to a more severe impairment.

“It’s hard to attribute what’s directly related to covid and what’s a progression of conditions they already have,” said Gut.

That wasn’t true for Richard Gard, 67, who lives just outside New Haven, Connecticut, a self-described “very healthy and fit” sailor, scuba diver, and music teacher at Yale University who contracted covid in March 2020. He was the first covid patient treated at Yale New Haven Hospital, where he was critically ill for 2½ weeks, including five days in intensive care and three days on a ventilator.

In the two years since, Gard has spent more than two months in the hospital, usually for symptoms that resemble a heart attack. “If I tried to walk up the stairs or 10 feet, I would almost pass out with exhaustion, and the symptoms would start — extreme chest pain radiating up my arm into my neck, trouble breathing, sweating,” he said.

Dr. Erica Spatz, director of the preventive cardiovascular health program at Yale, is one of Gard’s physicians. “The more severe the covid infection and the older you are, the more likely it is you’ll have a cardiovascular complication after,” she said. Complications include weakening of the heart muscle, blood clots, abnormal heart rhythms, vascular system damage, and high blood pressure.

Gard’s life has changed in ways he never imagined. Unable to work, he takes 22 medications and can still walk only 10 minutes on level ground. Post-traumatic stress disorder is a frequent, unwanted companion.

“A lot of times it’s been difficult to go on, but I tell myself I just have to get up and try one more time,” he told me. “Every day that I get a little bit better, I tell myself I’m adding another day or week to my life.”

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

Pregnant Women Raise Risk of Complications by Using OTC Pain Relievers

By Pat Anson, PNN Editor

Pregnant women who take over-the-counter pain relievers are one-and-a-half times more likely to have complications, including stillbirth and premature delivery, according to a large new study.

Researchers at the University of Aberdeen analyzed data from over 151,000 pregnancies in the UK from 1985-2015, looking for medical notes indicating the women used paracetamol (acetaminophen), aspirin or the non-steroidal anti-inflammatory drugs (NSAIDs) diclofenac, naproxen and ibuprofen — either alone or in combinations.

The findings, recently published in BMJ Open, show a significantly higher risk of a preterm delivery, neonatal death, low birth weight and other health problems in babies born to mothers who used OTC pain relievers. Neural tube defects of the brain, spine or spinal cord were 64% more likely; while hypospadias, a birth defect affecting the penis, was 27% more likely.

“Over-the-counter analgesics consumption during pregnancy was associated with a substantially higher risk for adverse perinatal health outcomes in the offspring. The use of paracetamol in combination with other non-steroidal anti-inflammatory drugs conferred the highest risk,” wrote lead author Aikaterini Zafeiri, PhD. “The increased risks of adverse neonatal outcomes associated with non-prescribed, over-the-counter, analgesics use during pregnancy indicate that healthcare guidance for pregnant women regarding analgesic use need urgent updating.”

One of the more surprising aspects of the study is how use of the five analgesics by pregnant women grew dramatically over the 30-year study period.  In 1985, only 1.8% reported using one of the pain relievers. By 2015, that had grown to 70.6% -- with most of the increase coming in the last seven years of the study.

Although it is believed to be one of the largest and most comprehensive studies of its kind, the research was limited. The duration, dose and stage of the pregnancy when analgesics were consumed were not recorded. The health of the mothers and babies later in life was also not studied.

But given the substantial increase in analgesic use during pregnancy and the higher risk of complications, researchers say more caution is needed on use of the drugs.

“The ease of access to non-prescription painkillers, in combination with availability of misinformation as well as correct information through the internet, raises safety concerns,” said Zafeiri. “It should be reinforced that paracetamol in combination with NSAIDs is associated with a higher risk and pregnant women should always consult their doctor or midwife before taking any over-the-counter drugs. We would encourage a strong reinforcement of the official advice for pregnant women.”   

Previous studies have linked prenatal use of paracetamol to autism, hyperactivity and behavioral problem in children. Despite the findings, drug regulators in the UK and US maintain that it is safe for pregnant women to use paracetamol (acetaminophen).

“Paracetamol is the first choice of painkiller if you're pregnant or breastfeeding. It's been taken by many pregnant and breastfeeding women with no harmful effects in the mother or baby,” the UK’s National Health Service (NHS) says on its website.

The Food and Drug Administration also does not caution pregnant women about using acetaminophen. The agency said in 2015 that the evidence was “too limited” to justify such a warning.  

Meanwhile, drug regulators in Australia are so concerned about recent deaths involving paracetamol that they may restrict access to the drug. Australia’s Therapeutic Goods Administration (TGA) has commissioned a report by an expert panel on the risks of paracetamol misuse.

“While paracetamol has well established safety and toxicity profiles, the wide use is paralleled by a high prevalence of accidental and deliberate paracetamol poisoning in the community, in both adults and children,” the TGA said in a statement earlier this month.

“The TGA is aware of concerns, particularly of families and healthcare professionals of affected consumers of paracetamol, regarding the number of poisonings and deliberate overdoses from paracetamol obtained from general retail outlets, and whether current access restrictions are appropriate.”

Australia currently regulates the quantity and dose of paracetamol sold over-the-counter. The independent commission will consider if stricter buying limits should be imposed. 

Long Covid Symptoms Persist Two Years After Hospitalization

By Pat Anson, PNN Editor

About half the patients who were first hospitalized in China with the COVID-19 virus still had symptoms of pain, fatigue or insomnia two years after being discharged, according to a new study that suggests that long covid may persist long after the initial infection.

Long covid is a poorly understood disorder characterized by body pain, fatigue, cognitive impairment and difficulty sleeping.

Wuhan, China was the epicenter of the COVID-19 pandemic in early 2020, which makes it a good place to study how infections with the original strain of the virus affect patients long-term.

Researchers at the China–Japan Friendship Hospital in Beijing followed nearly 1,200 patients who were hospitalized in Wuhan with acute COVID-19 between January 7 and May 29, 2020, and reassessed them six months, 12 months and two years after discharge.

While their physical and mental health generally improved over time, regardless of disease severity, researchers found that 55% of the Wuhan patients still had at least one Covid symptom after two years, compared to 68% after six months. Many reported a poorer quality of life, less ability to exercise, more mental health problems, and increased use of healthcare services compared to people who were not infected.

“Our findings indicate that for a certain proportion of hospitalised COVID-19 survivors, while they may have cleared the initial infection, more than two years is needed to recover fully from COVID-19,” said lead author Bin Cao, MD, Vice President and Director, Department of Pulmonary and Critical Care Medicine, China-Japan Friendship Hospital

“Ongoing follow-up of COVID-19 survivors, particularly those with symptoms of long COVID, is essential to understand the longer course of the illness, as is further exploration of the benefits of rehabilitation programmes for recovery. There is a clear need to provide continued support to a significant proportion of people who’ve had COVID-19, and to understand how vaccines, emerging treatments, and variants affect long-term health outcomes.”

Nearly 90% of the Wuhan patients were well enough to return to work after two years, despite lingering health problems. Nearly a third (31%) reported fatigue or muscle weakness and sleep difficulties. They were also more likely to report joint pain, palpitations, dizziness, headaches, difficulty breathing, anxiety and depression.

“To the best of our knowledge, this is the longest longitudinal follow-up study of individuals who have recovered from acute COVID-19,” researchers reported in The Lancet Respiratory Medicine.

“Throughout the 2 years after acute infection, hospital survivors with COVID-19 continued to recover in terms of symptomatic sequelae, exercise capacity, mental health, and quality of life, regardless of initial disease severity, but a fairly high burden of symptoms was still seen at 2 years. The COVID-19 survivors had not returned to the same health status as the general population 2 years after acute infection, so ongoing follow-up is needed to characterise the protracted natural history of long COVID.”

More than two years after COVID-19 first appeared in Wuhan, China is having another COVID crisis – this one caused by the Omricon variant of the virus. About 400 million people are currently living under some form of lockdown, with residents of China’s largest city, Shanghai, confined to their homes for weeks.

Class Action Lawsuit by Pain Patient Against CVS Moves Forward

By Pat Anson, PNN Editor

A federal judge has ruled that a class action lawsuit against CVS may continue over the pharmacy chain’s refusal to fill high dose opioid prescriptions for a Florida woman.

Edith Fuog, a breast cancer survivor who lives with trigeminal neuralgia, lupus, arthritis and other chronic pain conditions, filed suit against CVS in 2020, alleging the company discriminated against her and violated the American with Disabilities Act (ADA). Her complaint was filed in federal court in Rhode Island, where CVS has its corporate headquarters.

The lawsuit alleges that CVS pharmacists refused to fill her opioid prescriptions nearly 30 times because the daily doses exceeded 90 morphine milligram equivalents (MME), a threshold considered risky under the 2016 CDC opioid guideline. Although the guideline is voluntary, many healthcare providers have adopted it as a mandatory policy.   

This week Judge William Smith rejected a CVS motion to dismiss the lawsuit, essentially ruling that because Fuog needed a higher dose to treat pain from her medical conditions, she was legally qualified as a disabled person.

“Ms. Fuog has pleaded sufficient facts for the Court to conclude that it is plausible that prescriptions over the threshold are generally denied meaningful access to this benefit, and also disproportionally or predominantly disabled,” Judge Smith wrote in his opinion.

“She has alleged a specific dose-and-duration threshold and provided well-pleaded facts supporting a strong correlation between those over the threshold and disability. While she will have much to prove as the case progressed, these pleadings push past the plausibility bar.”

Judge Smith agreed to drop CVS Caremark as a defendant in the lawsuit, saying there wasn’t a clear enough allegation against the company’s pharmacy benefit manager. But the rest of the potentially precedent setting case will continue.   

“He basically said there’s no doubt that she’s disabled. And there’s no doubt that there’s discrimination going on,” Fuog told PNN.  “It’s a huge step. And we’ve got all this in his own words, telling us this is real, it’s happening, it’s unfair and it’s discrimination.”

“We are very pleased with the Court’s ruling and look forward to moving ahead and litigating the claims on Edith’s behalf,” said Scott Hirsch, Fuog’s lawyer. “We are always happy to speak with other individuals who are being denied the filling of their legitimate opioid prescriptions. They can go to the website we have setup and get more information.”

Longtime Problem for Patients

Pain patients across the U.S. have complained for years about pharmacies refusing to fill their opioid prescriptions or reducing them to lower doses. It’s also not uncommon for patients to encounter delays and flimsy excuses about not filling a prescription, such as a pharmacist claiming a particular opioid was out of stock.

The CVS case and a similar lawsuit against Walgreen’s in California are believed to be the first class action cases to address the problem. Class action suits allow plaintiffs to prosecute a case in civil court and receive compensation for their injuries on behalf of others.

“I was thrilled with this opinion. I think it’s very well-reasoned and applies the ADA appropriately,” said Kate Nicholson, a civil rights lawyer who at one time worked for the Justice Department and helped draft federal regulations under the ADA. She is now Executive Director of the National Pain Advocacy Center (NPAC).

“I mean it’s ridiculous that this woman went to 30 different pharmacies and couldn’t get her prescription refilled. That is highly problematic,” Nicholson told PNN.

Ironically, CVS and several other pharmacy chains face multiple lawsuits for filling too many opioid prescriptions and allegedly contributing to the nation’s opioid crisis. CVS recently reached a $484 million settlement with the state of Florida to end opioid litigation there.

Pharmacists have a legal right to refuse to fill prescriptions they consider suspicious or inappropriate, but should first take steps to verify whether a prescription is legitimate and medically necessary, such as calling the prescribing doctor. Fuog’s lawsuit alleges that CVS pharmacists refused to call her doctor or even look at her medical records.

“Which is why I think the judge was very careful on this case to say CVS has a perfectly legitimate basis for looking at high dose prescribing,” said Nicholson. “They just can’t do it in this arbitrary way.”

Anti-Inflammatory Drugs May Contribute to Chronic Pain

By Pat Anson, PNN Editor

Anti-inflammatory drugs that are widely used to treat short-term acute pain disrupt the body’s natural healing process and increase the chances of developing chronic pain, according to a provocative new study by an international team of researchers.

If true, it means that ibuprofen, naproxen, diclofenac and other non-steroidal anti-inflammatory drugs (NSAIDs) used by millions of people every day for the temporary relief of acute pain may contribute to long-term pain that is even harder to treat.    

“For many decades it’s been standard medical practice to treat pain with anti-inflammatory drugs. But we found that this short-term fix could lead to longer-term problems,” said co-author Jeffrey Mogil, PhD, Professor of Pain Studies and the Canada Research Chair in the Genetics of Pain at McGill University in Montreal.

In a series of studies, Mogil and his colleagues first analyzed genes and immune cells in the blood of 98 patients with acute lower back pain (LBP), noting which patients became free of pain and which ones developed chronic pain after three months.  

In patients who became pain free, there was an early inflammatory response to acute pain that activated neutrophils -- a type of white blood cell that helps the body fight infection.

In patients with chronic pain, there was no inflammatory immune response. This suggests that neutrophils play an active role in resolving pain and protecting patients from transitioning to chronic pain.

“Neutrophils dominate the early stages of inflammation and set the stage for repair of tissue damage. Inflammation occurs for a reason, and it looks like it’s dangerous to interfere with it,” said Mogil.

The study findings, published in Science Translational Medicine, were replicated in a cohort of patients with temporomandibular disorder (TMD), a painful inflammation of the jaw.

Researchers also tested their theory on laboratory animals, giving mice with acute pain the anti-inflammatory steroid dexamethasone or the NSAID diclofenac. While the drugs were initially effective, researchers found that blocking neutrophils in mice ultimately prolonged their pain up to ten times the normal duration. Three other analgesics without anti-inflammatory properties (gabapentin, morphine and lidocaine) produced short-term pain relief without affecting the overall duration of pain in mice.

These findings were also supported by a separate analysis of health records for 500,000 people in the United Kingdom with acute LBP. Those that took NSAIDs were nearly twice as likely to still have pain 2 to 6 years later than those who did not take NSAIDs. Patients who took acetaminophen (paracetamol) or antidepressants – neither of which are anti-inflammatory --  were not at higher risk of transitioning to chronic LBP.

“Our findings suggest it may be time to reconsider the way we treat acute pain. Luckily pain can be killed in other ways that don’t involve interfering with inflammation,” said co-author Massimo Allegri, MD, Head of Pain Service at Policlinico of Monza Hospital in Italy and Ensemble Hospitalier de la Cote in Switzerland.

Researchers say their findings should be followed up with larger clinical trials directly comparing the long-term effects of anti-inflammatory drugs to other pain relievers that don’t disrupt inflammation.

“Together, our results suggest that active immune processes confer adaptation at the acute pain stage, and impairment of such inflammatory responses in subjects with acute LBP (or TMD) increases the risk of developing chronic pain. These adaptive inflammatory responses are intrinsically transcriptionally driven, probably modified by both genetics and environmental factors, and can be inhibited by steroids and NSAIDs,” researchers said.

“Our conclusions may have a substantial impact on medical treatment of the most common presenting complaints to health care professionals. Specifically, our data suggest that the long-term effects of anti-inflammatory drugs should be further investigated in the treatment of acute LBP and likely other pain conditions.”

NSAIDs are widely used to treat everything from fever and headache to low back pain and arthritis. They are in so many different pain relieving products, including over-the-counter cold and flu medications, that many consumers may not be aware how often they use NSAIDs. At high doses, studies have found that NSAIDs increase the risk of a heart attack or stroke.

The current draft revision of the CDC opioid guideline recommends that NSAIDs should be used for low back pain, painful musculoskeletal injuries, dental pain, postoperative pain, kidney stones and acute pain caused by episodic migraine.

Acetaminophen also has its risks. Long-term use has been associated with liver, kidney, heart and blood pressure problems. Acetaminophen overdoses are involved in about 500 deaths and over 50,000 emergency room visits in the U.S. annually.

Emergency Treatment of Arachnoiditis After Spinal Injection

By Dr. Forest Tennant, PNN Columnist

In rare cases, symptoms suggesting adhesive arachnoiditis (AA) may occur after a spinal tap or epidural injection (therapeutic or obstetrical). These early symptoms may include localized lumbar pain, headaches, burning sensations, dizziness, leg weakness and bladder dysfunction. Spinal fluid leaks or blood in the spinal canal are often suspected in these cases.  

If symptoms indicate the possibility that AA may be developing, we recommend emergency treatment to hopefully prevent the spinal nerve inflammation from spreading and becoming chronic. 

A problem that we have routinely discovered is that medical practitioners commonly have the false belief that they can see signs of AA on an MRI when symptoms begin or within a few hours or days after a spinal tap or epidural injection. But AA typically does not show on an MRI for at least four to six weeks. Consequently, early emergency treatment must be based on patient history and symptoms, rather than on MRI findings. 

At the First International Congress on Arachnoiditis and Tarlov Cysts in 2010, physicians Donna Holder and Antonio Aldrete recommended that methylprednisolone 500 mg be given intravenously every day for five days as an emergency treatment for AA.  

Since that time, a variety of intravenous methylprednisolone attempts with different dosages and frequency have been used by physicians as emergency treatment to prevent AA. Dr. Aldrete opined that intravenous methylprednisolone is only effective in preventing AA if given within 60 days after the spinal tap or epidural. 

We have used the following alternative treatments to intravenous methylprednisolone: 

1. Medrol (methylprednisolone) six-day oral dose pack

2. Ketorolac 30 to 60 mg injection for three consecutive days

3. Medroxyprogesterone 10 mg given twice a day for six days

In some, but not all cases, AA symptoms will abate during the week that either intravenous methylprednisolone or the alternative treatments are administered. In most cases, however, symptoms reduce but don’t totally abate. The reason for this is unclear, but a reasonable assumption is that spinal canal inflammation may not be totally reversed once symptoms begin. 

If pain and other symptoms don’t totally abate, we recommend that the patient begin a three-component medical protocol for AA described in this bulletin, which includes nutritional, physiologic and pharmacologic elements. Patients should remain on these medical treatments until and if their pain and other symptoms resolve. 

It is unclear why only a small percentage of persons who have spinal taps or epidural injections develop AA. It is also unknown why symptoms that begin after these procedures usually don’t abate. 

A New Handbook for Practitioners

Our new book, "Clinical Diagnosis and Treatment of Adhesive Arachnoiditis” is now available on Amazon. 

This handbook for medical practitioners has been written for one simple reason.  AA is no longer a rare disease.  We conservatively estimate that there are at least 1.75 to 2.75 million adults in the U.S. who have AA.  

In the past, the cause of their back pain was often listed as unknown or inappropriately labeled as failed back syndrome, degenerative spine or simply low back pain. 

It is our fervent hope that this book will help medical practitioners and their patients diagnose and treat this most debilitating disease.

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.   

Roger Chriss: Remembering a True Helper and Advocate

By Pat Anson, PNN Editor

“Roger was a good friend and caring person. He will be missed tremendously.”

“May this dear, wonderful, kind man rest in the peace he deserves. Free of pain.”

“Heaven just got a great mathematician. Heaven's gain. Our loss.”

Those are just a few of the heartfelt tributes being posted online about PNN columnist Roger Chriss, who was a longtime advocate and friend to people living with Ehlers-Danlos syndrome (EDS) and other rare diseases.

Roger died unexpectedly on May 2 at a hospital near his home in Kirkland, Washington. He was 56 years old. 

Although Roger lived with EDS – a chronic and progressive disease that affects the joints, blood vessels and other connective tissues -- it’s unclear if that contributed to his death.  His brother Neil says Roger experienced chest pains and drove himself to the hospital, where he was diagnosed with a mild heart attack.

“He was given blood thinners as part of standard care. He was due to be released and suddenly collapsed and was found with no pulse and no blood pressure,” said Neil Chriss. “In trying to figure out what had caused the collapse they found he had lost a lot of blood internally, so they suspected this had to do with the combination of blood thinners and E-D related weakness in blood vessel walls.

“You should all know that my brother derived great meaning being part of your community. We talked frequently about E-D and the difficulties both mental and physical that go along with it. It’s sad for me to remember that he talked about losing people from the community being an all-too-often experience.”

ROGER CHRISS

Roger was an active member and strong supporter of The Ehlers-Danlos Society, where he co-hosted a support group for men with EDS. He was the first recipient of the organization’s Community Advocacy Award.

Roger grew up in Westchester County, New York where he developed an early interest in mathematics, music, computers and foreign languages. He graduated from Wesleyan University in 1987 with a major in East Asia studies. He later earned a Master’s degree at the Monterey Institute of International Studies and remained there as a faculty member.

Roger was fluent in Japanese, Spanish, French, Latin and other languages. He was a prolific writer and authored two books that reflected his diverse interests: "A Comedy of Time" and "Translation as a Profession."

Roger became a columnist for PNN in 2017 and later joined our board of directors. I can honestly say I learned something new from every column that Roger wrote, whether he was debunking myths about the opioid crisis, challenging the hype about medical cannabis, or advocating for more funding of rare disease research.

I admired Roger’s dedication to the truth, in an age when misinformation, hype and political dogma drives too much of the news coverage about healthcare. He brought an abiding concern about patients to every issue he wrote about, and a farsighted view of where it might take us.

In recent years, Roger posted almost daily on Inspire, an online health community for patients, where he supported and made many friends in the EDS and rare disease community. He used the screen name “Seshet” – a variation on the name of an ancient Egyptian deity of wisdom, science and mathematics. It was a fitting nickname for Roger.

“Seshet was truly a guiding light to me and so many others through this pandemic,” one poster wrote. “I’m sure he is in heaven calculating the probabilities of why this happened to him, but I know in his core he understood the unpredictability of life.”

“While his life was too short, his life had great meaning. He was so very wise and generous with this community, a true helper, which I believe is life’s highest calling,” said another.

Roger’s family is planning a private memorial for him. In lieu of flowers, they’re asking friends to consider making a gift to The Ehlers-Danlos Society. Click here for details. 

Smoking Cannabis Improves Energy Levels

By Pat Anson, PNN Editor

People who frequently smoke marijuana are often portrayed in popular culture as unmotivated, low-energy slackers who spend much of their time laying in bed or bound to a couch. That stereotype of the “lazy stoner” is not only unfair – it’s inaccurate according to a new study of cannabis consumers.

In an analysis of self-reported data from people who smoked or vaporized cannabis flower to treat fatigue, researchers at the University of New Mexico found that over 91 percent reported higher energy levels soon after consuming cannabis.

"Despite the conventional beliefs that frequent cannabis use may result in decreased behavioral activity, goal-pursuit, and competitiveness, or what academics have called 'amotivational syndrome,' people tend to actually experience an immediate boost in their energy levels immediately after consuming cannabis," said co-author Jacob Miguel Vigil, PhD, a psychology professor at UNM.

The study findings, published in the journal Medical Cannabis and Cannabinoids, are the latest derived from the Releaf App, a free mobile software program that collects self-reported, real-time information from people on their use of cannabis and its effect on chronic pain, insomnia, anxiety and other medical conditions.

Fatigue is a core symptom of many chronic illnesses, including fibromyalgia, immune system disorders and myalgic encephalomyelitis, also known as chronic fatigue syndrome (ME/CFS).

The UNM study is based on data from 3,922 cannabis sessions recorded by 1,224 people who used the Releaf app to monitor real-time changes in their symptoms and side effects.

Researchers found that people who smoked cannabis joints experienced higher energy levels than those who used a vaporizer or pipe. Surprisingly, tetrahydrocannabinol (THC) and cannabidiol (CBD) levels in the cannabis appeared to have no correlation with energy and fatigue levels. The strain of cannabis used also made little difference.     

"One of the most surprising outcomes of this study is that cannabis, in general, yielded improvements in symptoms of fatigue, rather than just a subset of products, such as those with higher THC or CBD levels or products characterized as sativa rather than indica," said co-author Sarah Stith, PhD, an economics professor at UNM.

“Our observation that the major cannabinoids tetrahydrocannabinol and cannabidiol were largely uncorrelated with changes in feelings of fatigue suggest that other minor cannabinoids and phytochemicals such as terpenes may be more influential on the effects of using cannabis than previously believed,” added Vigil.

Terpenes are aromatic compounds that give plants such as lavender and citrus their fragrance. In cannabis, terpenes have a distinctive “skunky” smell, but may be responsible for much more. Recent research found that terpenes appear to have an “entourage effect” on cannabinoids that boost their pain-relieving effects.   

“In the near future, I anticipate that patients will have the opportunity to access more individualized cannabis products, with distinct and known combinations of chemical profiles for treating their specific health needs and lifestyles," said Vigil.

In addition to boosting energy levels, researchers say cannabis helped most users feel more relaxed and peaceful. Negative side effects reported by a minority of users were dry mouth and feeling mentally foggy.   

My Botched Anesthesia During Surgery

By Victoria Reed, PNN Columnist

Have you ever had elective surgery that didn’t go as planned, but instead caused more pain? Did it make you think twice about having surgery again?

Having a chronic illness means that some surgeries are necessary to improve quality of life. People suffering from rheumatoid arthritis (RA) often end up having surgeries, as joint pain and deformity are common complications. Surgeries can include joint replacement or removal of rheumatoid nodules -- subcutaneous lumps or masses that can attach to underlying tissue.

Nodules are associated with more severe forms of RA and usually occur near elbow joints or joints of the hands and feet. About 20% of RA patients suffer from these nodules, which usually aren’t painful, but can cause complications.

I am one of the 20% of RA patients who has developed these nodules. Years ago, I had one growing on the underside of my right big toe. It grew so large that it was causing pain, and I was having trouble walking on that foot. I was compensating for the discomfort by using just the outside of my foot, so I consulted with a podiatrist to talk about having the nodule removed.

The doctor advised me that it could be surgically removed, but also that it could possibly grow back over time. Considering that it was affecting my ability to walk comfortably, I decided to go ahead with the surgery.

For some reason, the doctor did not want to use general anesthesia during the surgery and opted for local injections of an anesthetic to numb the toe.  This did not go well for me. As the surgical assistant injected the medication, he must have hit a nerve because it caused some of the most excruciating pain of my life! It was more painful than childbirth. As I screamed in pain, he injected the toe THREE more times, each one being equally painful.

Needless to say, that was a very traumatic experience, but the toe was indeed numb enough to cut into. After the nodule was removed, which was described in the pathology report as a “wad of gum” type of mass, I was sent home to recover, hopeful that the toe would be as good as new.

It wasn’t.

As the anesthetic wore off, I realized that I had no feeling in the toe. I called the office and inquired as to why I still had no feeling in it and was told to give it time. They assured me that the sensation would eventually return. A week passed, then another week, and still there was no feeling in parts of the toe. Other parts had a new and strangely painful tingling sensation. I called the office again and was told to allow more time for full sensation to return.

Nine years have passed and there has been no improvement. I suffer from sharp, stabbing nerve pain in that toe, which is still completely numb in certain spots. Unfortunately, the nodule has grown back as well. I’m not sure if the injections caused the nerve damage or if the actual removal of the nodule did, but had I received general anesthesia, I would not have had to suffer through those excruciatingly painful injections.

Because of that horrible experience, I am now very reluctant to consider elective surgery again.

We, as chronic pain sufferers, must always advocate for ourselves. Or have someone advocate for us, if we are unable. We should question the decisions made by our medical providers if they don’t seem right or if we are unsure or nervous about a procedure. While there are many competent doctors and surgeons, unfortunately, there are some that are not and who don’t always have our best interest in mind.

I never could have predicted the horrible outcome of that surgery. But the lesson I’ve learned is to ask as many questions as possible prior to any procedure and to thoroughly research any physician who is going to cut into my body. One good question to ask is, “How many of these surgeries have you performed?” Newer surgeons can be perfectly capable, but the more experienced a surgeon is, the better the outcome will likely be for you.

RA can present many challenges, mainly severe pain, but it can also affect a patient’s mobility and morbidity. I will need to decide if I want to have another surgery to remove the recurrent toe nodule or decide if it is something I can learn to live with. Either way, I have learned some valuable lessons.

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

FDA Warns Companies Selling CBD and Delta-8 THC Products

By Pat Anson, PNN Editor

When Congress passed the 2018 Farm Bill and legalized hemp under federal law, the goal was to make it possible for U.S. farmers to grow hemp again as a cash crop for making everything from clothing and fuel to shampoo and horse feed. “Rope, not dope,” was the slogan used by the bill’s supporters, who pointed out that hemp contains less than 0.3% tetrahydrocannabinol (THC), the main psychoactive ingredient in marijuana.  

No one could possibly get high on hemp, could they?

It didn’t take long for the cannabis industry to figure out how. Many companies now make cannabidiol (CBD) products from hemp and tweak their chemical composition just enough to produce the euphoria that some consumers seek. A recent study by CBD Oracle found that some hemp-based edibles have 360% more THC than those sold in cannabis dispensaries. Over half the edibles they tested were mislabeled.

The Food and Drug Administration has been slow to regulate CBD products or confront mislabeling, but today the agency finally took action by sending the first warning letters to cannabis companies for selling products containing delta-8 tetrahydrocannabinol (delta-8 THC), which the agency considers an unapproved drug.

Delta-8 THC is one of over 100 cannabinoids found in marijuana, but is not present in significant amounts in hemp. However, some companies have found ways to concentrate delta-8 THC from hemp-derived CBD to give users a mild psychoactive and intoxicating effect.

Edibles containing delta-8-THC are being sold as candy, cookies, breakfast cereal, chocolate, gummies, tinctures and beverages. Because they are made from hemp, they can legally be purchased without an ID or marijuana prescription – even in states where medical or recreational marijuana is illegal.

"The FDA is very concerned about the growing popularity of delta-8 THC products being sold online and in stores nationwide. These products often include claims that they treat or alleviate the side effects related to a wide variety of diseases or medical disorders, such as cancer, multiple sclerosis, chronic pain, nausea and anxiety," FDA Principal Deputy Commissioner Janet Woodcock, MD, said in a statement. "It is extremely troubling that some of the food products are packaged and labeled in ways that may appeal to children.”

In the last two years, the FDA says it has received 104 reports of adverse events involving delta-8 THC, most of them involving edibles. National poison control centers have reported over 2,300 cases involving delta-8 THC products, including one death involving a child.

The FDA has previously warned companies about making unsubstantiated medical claims about CBD products, but these are the first warnings to target delta-8 THC specifically. The five companies that received the letters -- ATLRx, BioMD Plus, Delta 8 Hemp, Kingdom Harvest and M Six Labs make only vague medical claims on their websites, telling consumers about “dosing Delta-8 THC for optimal effects” and how their products help “alleviate stress, anxiety, and uneasiness.”

Curiously, some of the companies also sell CBD products made with delta-9 THC – a more potent cannabinoid that can be derived from hemp – which the FDA ignored in its warning, even though delta-9 is also an unapproved drug. The agency’s warning letters also say nothing about mislabeling. Simply having delta-8 in a product — at any dose — is considered illegal.

The cannabis industry is still coming to terms with all of this and how hemp legalization is having unintended consequences.

“We honestly never thought intoxicating products would be produced from hemp when we were advocating for legalization,” Erica Stark of the National Hemp Association told CBD Oracle. “Now the FDA needs to figure out how to regulate the industry.”

Will Congress amend federal law to protect consumers and regulate how hemp is utilized? A bill under consideration would raise THC levels even higher.

Under the proposed Hemp Advancement Act of 2022, which is supported by the hemp industry, the legal THC threshold for hemp products would be raised from 0.3 percent to 1 percent.  Participation in the hemp industry would also be expanded to include people with prior drug convictions.

Lipofilling Improved Pain and Function in Patients with Finger Osteoarthritis

By Pat Anson, PNN Editor

People who suffer from painful arthritic fingers have few treatment options to choose from. They can wrap their hand in a splint, take anti-inflammatory drugs or get steroid injections into their finger joints – all of which provide only temporary relief. More invasive surgical treatments include joint fusions or reconstruction, which can impair hand motion and take weeks to recover from.

German researchers have found that a less invasive treatment commonly used in plastic surgery – injecting fat tissue from one part of the body into another -- can provide lasting improvements in pain and function for patients with finger osteoarthritis. The technique – called lipofilling – resulted in “highly significant clear improvement" with no complications in a small pilot study of 15 patients.     

"We believe that for our patients the reduction of pain represents the most striking and important result, which also has the most pronounced and highly significant effect," said co-author Max Meyer-Marcotty, MD, Clinic for Plastic, Reconstructive, and Aesthetic Surgery/Hand Surgery in Lüdenscheid, Germany.

"Even over a long-term follow-up, the transfer of fatty tissue to arthritic fingers joints appears to provide a safe and minimally invasive alternative to conventional surgery for patients with osteoarthritis.”

In the lipofilling procedure, Meyer-Marcotty and his colleagues used liposuction to take a small sample of each patient's fatty tissue from their upper thigh or hip area. The autologous fat was then injected into their arthritic finger joints. Patients wore a splint around the treated fingers and took pain relievers for a week. There were no infections or other complications reported.

The researchers followed outcomes in 25 finger joints for an average of 44 months after treatment, and found that pain scores fell from a median of 6 (on a 10-point scale) before treatment to just 0.5 points at follow-up. Grip strength of the treated fingers approximately doubled, while fist closure and hand function performing everyday tasks also improved.

“Even after a follow-up examination period of 44 months, the transfer of fatty tissue to arthritic finger joints has shown itself to be a minimally invasive, safe, and promising alternative to conventional surgical techniques aimed at alleviating arthritic complaints, and one that among other things entails a highly significant improvement in postsurgical pain levels,” researchers reported in the journal Plastic and Reconstructive Surgery. “Further long-term follow-up studies of even larger patient cohorts would be needed to further corroborate these initial positive findings.”

In recent years, lipofilling procedures have been increasingly used in plastic and reconstructive surgery, as well as stem cell therapy.

When injected into patients, mesenchymal stromal cells (MSCs) in fat tissue can regenerate damaged or diseased tissue, including cartilage in arthritic joints. A small 2019 study found that MSCs collected from a patient’s bone marrow can significantly reduce pain from knee osteoarthritis for up to a year.

Osteoarthritis is a progressive joint disorder caused by the inflammation of soft tissue, which leads to thinning of cartilage and joint damage in the knees, hips, fingers and spine.

"The chance to preserve the joint with a minimally invasive procedure is of particular interest in the early, albeit painful, phases of finger osteoarthritis," said Meyer-Marcotty. "Since the lipofilling procedure is nondestructive, conventional joint surgery can still be performed later, if needed."

Drug Addiction Is the Problem, Not Prescription Opioids

By Christine Kucera, Guest Columnist

The Centers for Disease Control and Prevention (CDC) is the leading national public health institute of the United States. The agency is responsible for protecting the public from health and safety threats. 

In my opinion, the CDC has no business writing clinical guidelines! Medical guidelines for healthcare/disease management, medication management, and clinical decision making should be developed, reviewed and approved by a diverse team of clinical subject area specialists and key stakeholders, including medical specialists, medical groups, advisory teams, advocates and patients. Not regulatory agencies!

The 2016 CDC opioid guideline, as currently written, has harmed and damaged millions of lives, and caused unspeakable suffering. In effect, the CDC sanctioned torture by failing to promptly address and correct the negative impact of its guideline on individual patient care, addiction and pain management treatment and resources.

The CDC has clearly overstepped its authority by creating a guideline meant to regulate the use of prescription opioids. Any regulatory measures which prevent patients from accessing prescription opioids as indicated for their health and well-being are unethical and should be reconsidered, if not totally withdrawn.

The CDC continues to propagate the false narrative that any patients requiring prescription opioids for any type of pain are or will become addicts. And it continues to claim — without any evidence — that if opioid prescriptions are limited in quantity, type, duration and dose, there will be a reduction in addiction, overdose and death. The facts indicate otherwise. Overdoses are at record high levels.

The True Causes of Addiction

Substance addiction exists because our government has failed to address its true causes, which include poor access to addiction treatment, unethical pain treatment, lack of quality care standards across medical institutions, and lack of legislative laws that protect patients from suffering needlessly. 

Addiction is caused by preventable and manageable health disparities, untreated and undertreated mental and physical suffering, genetic metabolic variability, lack of resources, lack of all-inclusive healthcare insurance, lack of provider managed pain care, lack of treatment centers, lack of access to appropriately prescribed medications, lack of drug monitoring systems, lack of access to mental health and pain care providers, lack of timely access to a comprehensive network of providers, and lack of individualized care. 

Maybe if the CDC actually focused on the above health and safety issues, we would have guidance on solving the real problems. The CDC has failed miserably to recognize that individual pain care is as unique as the patient who is suffering in pain. Every single person that has pain seeks relief.

Relief comes in many different forms, both healthy and unhealthy. These forms of relief may be self-directed and/or medically managed by clinical staff and providers, and includes exercise, yoga, rest, mobilization, heat/ice therapy, massage, mindfulness, acupuncture, Chinese herbal medicine, bio-feedback, diet, weight loss, surgeries, water therapy, bicycling, strength/weight training, martial arts, immunotherapy, TENS, anti-inflammatories, anti-seizure medication, muscle relaxants, antidepressants, biologicals, medical/recreational cannabis, CBD, kratom, prescription opioids, illicit/illegal drugs and alcohol — to name a few. 

Every Patient is Different

The journey each patient in pain takes is individual. The pain you've experienced and lived with is different from mine and everyone else’s.  

The terms “acute pain” and “chronic pain” are also misleading and are part of the false narrative. Pain is a symptom. Its management depends on its physical and/or mental cause, not how long it lasts. Pain is the body's way of sending up a red flag that something is not right.

Duration means nothing in the world of pain, as every minute of the day is different in type, in location and in intensity. Pain goes through cycles, and no person experiences pain the same way.  

Until the individuals who wrote this God awful, evil guideline experience pain that is unrelenting, agonizing, non-stop, 24/7 for their entire life, they should back off the false narrative, go back into their non-medical cave, and leave the medical decision making up to the actual physicians who are trained to manage pain with all the tools available and at any quantity required by a patient.  

What the CDC should be addressing are the sources of suffering, identifying at-risk individuals and providing a framework for implementing resources and systems of care that are fluid and adaptive to the unique circumstances of each individual.  

There are too many outstanding questions and issues which also continue to impact patients and providers. What are the FDA and DEA’s roles and responsibilities? How do their policies meet the objectives of the CDC guideline to reduce addiction, overdose and death? What impact do they have on medical providers treating patients in pain? 

Addiction is the public health issue requiring CDC input, not the utilization of prescription opioids for pain treatment. 

Christine Kucera is an intractable pain patient survivor of over 30 years. She lives with reactive psoriatic arthritis, spondylitis, polyarthritis, sacroiliitis, degenerative disc disease, dermatomyositis, mixed connective tissue disease, psoriasis, lupus, spinal radiculopathy, thoracic outlet syndrome, endometriosis stage IV, and other painful conditions.

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

High-Frequency Spinal Cord Stimulators Provide More Pain Relief

By Pat Anson, PNN Editor

Spinal cord stimulators are often considered the treatment of last resort for patients with intractable or severe chronic pain. The surgically implanted devices emit low levels of electricity that reduce pain signals, but have high failure rates and often have to be removed because they’re ineffective, cause infections or need new batteries.

Two new studies suggest there are ways to improve the success rate of spinal cord stimulators (SCS) through improved patient selection and the use of high-frequency devices.

Low-frequency SCS (50 Hz) was first approved by the Food and Drug Administration for intractable back and leg pain in 1989. Six years later, the FDA approved high-frequency devices (10,000 Hz), that deliver pulses of electrical stimulation that are shorter in duration, lower in amplitude and do not cause paresthesia, an irritating sensation of tingling or prickling.

In a retrospective study of 237 patients who received stimulators between 2004 and 2020, researchers at the University of California San Diego School of Medicine reported that high-frequency devices were more effective at reducing pain and opioid use than low-frequency ones.

The study findings, published in the journal Bioelectronic Medicine, also show that male patients benefit more than women from high-frequency neuromodulation.

"Our work was sparked by a growing literature that demonstrate sex specific immune pathways differentially contribute to chronic pain processes," said senior author Imanuel Lerman, MD, an associate professor of anesthesiology at UC San Diego Health. "The observed parameter-specific (high versus low frequency) sex-based differences in spinal cord stimulation efficacy and opiate use are definitely intriguing.”

It’s not clear why men benefit more than women, but researchers believe it may be due to the male hormone testosterone having a modulating effect on pain signals. The sex differences may also be due to males and females processing chronic pain differently.

"Clearly more work needs to be done to carefully characterize sex specific pain regulatory pathways that may prove responsive to specific types of neuromodulation and or pharmaceutical therapies," said Lerman.

Improved Patient Selection  

Although most patients are required to undergo psychological testing and a trial treatment before getting a SCS, failure rates for the devices remain high at around 25 to 30 percent. With about 50,000 stimulators implanted in the U.S. every year, that means thousands of patients are getting poor results.

To improve patient outcomes, researchers at Florida Atlantic University developed machine-learning algorithms to help predict which patients may benefit from SCS. Working with a cohort of 151 SCS patients, they evaluated 31 features or characteristics in each patient.  

Researchers found two distinct clusters of patients which differ significantly in age, duration of chronic pain, preoperative pain levels and pain catastrophizing scores. They used computers to fine-tune the results, identifying the 10 most influential features that contribute the most to a successful SCS implant.

Results of the study, published in the journal Neurosurgery, demonstrate for the first time the ability of machine-learning algorithms to predict long-term patient response to SCS placement. The next step is to validate the data in future patients to ensure that the algorithm is useful in real-world situations, not just computer models.

"Our study resulted in the development of a model to predict which patients would benefit from spinal cord stimulation," said lead author Julie Pilitsis, MD, dean and vice president of medical affairs at Florida Atlantic University's Schmidt College of Medicine.  "After we validate this work, our hope is that this machine-learning model can inform a clinical decision support tool to help physicians better choose which patients may be most appropriate."

SCS is no longer limited to patients with intractable back and neck pain. Last year the FDA expanded the use of SCS to include lower limb pain from diabetic neuropathy.  Stimulators are also being used on patients with Complex Regional Pain Syndrome (CRPS).

A decision to get a SCS shouldn’t be taken lightly. A 2018 study by a team of investigative journalists found that stimulators have some of the worst safety records of medical devices tracked by the FDA. A 2020 FDA review of adverse events involving SCS found that nearly a third were reports of unsatisfactory pain relief. The review also identified nearly 500 deaths linked to the devices, along with nearly 78,000 injuries and 30,000 device malfunctions.