Another Look at the Opioid Risk Tool

By Dr. Lynn Webster

I'm a proud grandfather to two young granddaughters. They are my world. Watching the U.S. Supreme Court rescind women's right to decide what to do with their own bodies made me feel angry that my granddaughters will be subjected to dehumanizing discrimination.

This tyranny against women extends beyond the Supreme Court’s decision over Roe vs. Wade.

I have read multiple accounts of women who are being denied access to opioid medication because they acknowledge a history of toxic adverse experiences as children or adolescents. Many such instances have occurred after women completed the Opioid Risk Tool, a questionnaire that asks a person if they have a history of preadolescent sexual abuse.

The refusal to prescribe opioids to women with a history of preadolescent sexual abuse is a defensive measure by providers to avoid being accused of causing an Opioid Use Disorder (OUD).

Why I Developed the Opioid Risk Tool

The Opioid Risk Tool (ORT) that I developed more than 20 years ago was designed to assess the risk of someone who was prescribed opioids for chronic pain treatment showing aberrant drug-related behavior.

The ORT was a simple questionnaire that could be administered and scored in less than a minute. It was developed at a time when we had no way to assess the risk of developing opioid abuse in patients who were prescribed an opioid for non-cancer pain. We needed a tool to help evaluate whether the risk of potential harm from opioids outweighed the potential good for each individual.

I never intended for doctors to use the ORT to determine who should or shouldn’t be prescribed an opioid. My goal was to help doctors identify patients who might require more careful observation during treatment, not to deny the person access to opioids.

Since abuse and addiction are diagnosed by observing atypical behaviors, knowing which patients are at greatest risk for displaying those behaviors is useful in establishing appropriate levels of monitoring for abuse. This was intended to protect the patient from potential harm. It was never supposed to be used as an excuse to mistreat patients.

The original version of the ORT contained 10 questions, including whether a patient had a history of preadolescent sexual abuse. Women who answered "yes" scored 3 points; while men who responded affirmatively scored 0 points. The higher you scored, the more closely your doctor would need to monitor your opioid use during your treatment.

The ORT questionnaire was based on the best evidence at the time. Multiple studies have since confirmed the validity of the questions used in the questionnaire. However, many people have criticized the question that asks about a history of preadolescent sexual abuse because of a perceived gender inequity. In addition, some doctors have generalized the ORT's question about preadolescent trauma so that it applies to a history of female sexual abuse at all ages.

I have written that the ORT has been weaponized by doctors who are looking for a reason to deny patients -- particularly, women -- adequate pain medication.

There are doctors who use their power to determine whether to treat a woman's chronic pain with an opioid or allow her to suffer needlessly based on the ORT's answers. This is no less malevolent than a forced taper resulting in suicides or the use of the CDC opioid prescribing guideline to criminally charge providers for not following the CDC's recommendation. In all of these situations, an injustice is being committed against innocent people.

It is also not much different from the Supreme Court’s decision to ignore a woman’s right to access full reproductive rights. Both are attacks on women.

Fortunately, Martin Cheatle, PhD, and his team published a revised Opioid Risk Tool in the July 2019 edition of the Journal of Pain. In his research, Dr. Cheatle found that a revised ORT using 9 questions instead of 10 was as accurate as, if not better than, the original ORT in weighing the risk of patients for OUD. The revised ORT eliminates the use of a woman's sexual abuse history as a risk factor.

At a time when females have had their human rights taken away by a Supreme Court vote, it is especially appropriate to reconsider how we assess risks for potential opioid abuse for women.

It distresses me to know that, while the original ORT served to help assess the risk opioids posed for individuals, it has also caused harm. Since the question about a woman's sexual abuse history does not provide any additional benefit, there is no reason to retain it. The revised ORT should be used instead of the original ORT.

Lynn R. Webster, MD, is Senior Fellow at the Center for U.S. Policy (CUSP) and Chief Medical Officer of PainScript. He also consults with the pharamaceutical industry.

Lynn is the author of the award-winning book The Painful Truth, and co-producer of the documentary It Hurts Until You Die. You can find him on Twitter: @LynnRWebsterMD.

What’s Missing in ‘Elvis’ Movie: The King’s Chronic Illness

By Pat Anson, PNN Editor

There’s a scene towards the end of the new “Elvis” movie when you know the end is coming soon. Presley, as depicted by actor Austin Butler, collapses in a hallway minutes before being scheduled to take the stage at the International Hotel in Las Vegas.

Instead of rushing an unconscious Elvis to a hospital, manager Tom Parker --- played by a surprisingly villainous Tom Hanks -- declares that the show must go on and summons “Dr. Nick” to make it right. After a quick injection of stimulant drugs, Elvis recovers just enough to sing, dance and entertain an adoring crowd in a packed showroom.   

That one scene sums up how the real Elvis Presley spent his final years before dying of an apparent heart attack in 1977 at the young age of 42. Popping pills. Slurring his words. Deeply depressed. And driven to continue performing by “Colonel” Parker and others.

“They really tried to push Elvis beyond his capacity in the last few years of his life. He was disabled,” says Dr. Forest Tennant, a retired physician and pain management expert who is one of the last people alive to be intimately familiar with Elvis’ drug use and medical problems.

In 1981, Tennant was hired by an attorney for Dr. George Nichopoulos (Dr. Nick), who faced criminal charges in Presley’s death. Tennant reviewed the autopsy report, medical records and a confidential 161-page private investigation, and testified as a defense witness for Nichopoulos, who would be acquitted of charges of overprescribing drugs.

After the trial, Tennant remained curious about Elvis’ medical problems and continued his research while treating people with intractable pain. The knowledge and experience Tennant gained in the last 50 years led to his recent book, appropriately titled “The Strange Medical Saga of Elvis Presley.”  

Elvis did indeed suffer from heart problems aggravated by an excessive use of drugs, but Tennant believes the ultimate cause of his death was a connective tissue disorder called Ehlers-Danlos syndrome (EDS), a major cause of intractable pain and other chronic health problems.

A diagnostic screening tool for EDS didn’t exist when Elvis was alive and few physicians were even aware of the condition. But Tennant thinks Presley had all the symptoms of EDS, including an unusual degree of flexibility and double jointness that allowed him to swing his hips and gyrate wildly. Those sexy dance moves helped make Elvis famous, but they also foretold what lay in store for him.

“EDS is a genetic connective tissue collagen disorder, and what that means is that you are genetically predetermined to have your collagen in certain tissues either disappear or deteriorate or become defective, and to put it bluntly, you can have a rectal problem and an eye problem at the same time due to the same cause because your collagen is deteriorating in these tissues,” Tennant told my colleague Donna Gregory Burch in a 2021 interview. “If you get a severe case like Elvis Presley, your life is going to be very miserable, and you're going to die young unless you get vigorous treatments.”      

The day before he died, a dentist gave Presley codeine for an aching tooth, not realizing how sick he was or that codeine could cause his heart to stop. Elvis collapsed in the bathroom 24 hours later. His sudden death led to rumors that he died from an overdose or even a horrible case of constipation. The truth is more complex.

“Nothing happened to Elvis Presley that we don't have a good logical, scientific explanation for now. But certainly back in those days we didn't,” Tennant explained. “Elvis Presley had multiple diseases. He was terribly ill, and he died accidentally in some ways with a dentist giving him codeine for his bad tooth, and his bad teeth were also part of the same disease that gave him a bad colon and a bad eye and a bad liver. They were all connected.

“He had all these metabolic defects due to his genetics, and so the codeine built up in his system. He had this terrible heart, so he died suddenly, within seconds, as he was trying to sit on the commode.”

Fortunately, the “Elvis” movie spares us any final scenes like that – ending instead with actual clips from one of Presley’s last concerts. They show a tired and very sick man, aged beyond his years and sweating profusely. But he still sang like “The King.”

All proceeds from sales of “The Strange Medical Saga of Elvis Presley” go the Tennant Foundation, which gives financial support to Pain News Network and sponsors PNN’s Patient Resources section.

Supreme Court Rules in Favor of Doctors Appealing Opioid Convictions

By Pat Anson, PNN Editor

In a precedent setting case, the U.S. Supreme Court has ruled in favor of two doctors who were convicted of prescribing high doses of opioid pain medication outside the usual standard of medical care. The ruling could potentially impact dozens of past and future cases in which doctors are accused of “overprescribing” opioids to their patients.

In their combined appeals, lawyers for Dr. Xiulu Ruan and Dr. Shakeel Kahn argued that jurors were not properly instructed that doctors are allowed to prescribe opioids under the Controlled Substances Act (CSA), as long as they act in good faith and with a medical purpose.

Unlike recent rulings which saw the high court bitterly divided over abortion and gun control, the justices ruled unanimously 9 to 0 in favor of the doctors, with some quibbling over the legal reasons.

Writing for the majority, Justice Stephen Breyer said government prosecutors failed to “prove beyond a reasonable doubt that the defendant knowingly or intentionally acted in an unauthorized manner" under the CSA.

In a concurring opinion, Justice Samuel Alito drew a finer line, saying doctors could still be prosecuted under the CSA if they knowingly acted in a way “foreign to medicine — such as facilitating addiction or recreational drug abuse.”

The high court’s ruling does not overturn the convictions of Ruan and Kahn. Instead, the cases are remanded back to lower courts for review, where charges against the doctors could be dismissed or new trials ordered.

‘Monumental Decision’

Pain patients and their advocates cheered the high court ruling, saying it could have a sweeping impact on pain management in the United States. Fearing prosecution by the DEA or state medical boards, many doctors have stopped prescribing opioids, tapered patients to lower doses, or simply stopped treating pain.  

“This is a monumental decision that will literally save lives because fewer patients will be abandoned by their doctors for fear of losing their freedom,” said Lynn Webster, MD, a Senior Fellow at the Center for U.S. Policy (CUSP) and Chief Medical Officer of PainScript.  “Physicians have been afraid to prescribe controlled substances even with an appropriate indication for fear of a government expert testifying they believe it is not the standard of care.  

“The Court’s decision will affect not only Ruan and all healthcare professionals with authority to prescribe any controlled substances, but millions of patients now and in the decades to come.”  

"I would say (the ruling) directly challenges many past convictions of doctors that were tainted by improper instructions to juries or anti-opioid biases by judges,” said patient advocate Red Lawhern, PhD. “It may also make future convictions more difficult given that the decision forces DEA and other law enforcement authorities to demonstrate beyond reasonable doubt that prescribers knew their practices exceeded accepted medical standards." 

“There remain other issues to be decided, but this decision was the right one for pain physicians and patients.  It affirmed the higher standard for the government to prove doctors acted with criminal intent,” said Kristen Ogden, a patient advocate and caregiver for her husband, who is disabled by intractable pain.

Complicating the cases of Ruan and Kahn is that they were both convicted of crimes outside of the CSA.

Ruan, who practiced in Alabama, prescribed Subsys to many of his patients, an expensive and potent fentanyl spray that was only approved by the FDA for breakthrough cancer pain. Ruan was also convicted of taking kickbacks from Insys Therapeutics, the maker of Subsys. He was sentenced to 21 years in prison.    

Kahn, who practiced in Wyoming and Arizona, was convicted of prescribing excessive amounts of oxycodone and running a criminal enterprise that resulted in the death of a patient. He is serving a sentence of 25 years.

Why Some Drugs Work Better on Different Types of Pain

By Dr. Rebecca Seal and Dr. Benedict Alder

Without the ability to feel pain, life is more dangerous. To avoid injury, pain tells us to use a hammer more gently, wait for the soup to cool or put on gloves in a snowball fight. Those with rare inherited disorders that leave them without the ability to feel pain are unable to protect themselves from environmental threats, leading to broken bones, damaged skin, infections and ultimately a shorter life span.

In these contexts, pain is much more than a sensation: It is a protective call to action. But pain that is too intense or long-lasting can be debilitating. So how does modern medicine soften the call?

As a neurobiologist and an anesthesiologist who study pain, this is a question we and other researchers have tried to answer. Science’s understanding of how the body senses tissue damage and perceives it as pain has progressed tremendously over the past several years. It has become clear that there are multiple pathways that signal tissue damage to the brain and sound the pain alarm bell.

Interestingly, while the brain uses different pain signaling pathways depending on the type of damage, there is also redundancy to these pathways. Even more intriguing, these neural pathways morph and amplify signals in the case of chronic pain and pain caused by conditions affecting nerves themselves, even though the protective function of pain is no longer needed.

Painkillers work by tackling different parts of these pathways. Not every painkiller works for every type of pain, however. Because of the multitude and redundancy of pain pathways, a perfect painkiller is elusive. But in the meantime, understanding how existing painkillers work helps medical providers and patients use them for the best results.

Anti-Inflammatories

A bruise, sprain or broken bone from an injury all lead to tissue inflammation, an immune response that can lead to swelling and redness as the body tries to heal. Specialized nerve cells in the area of the injury called nociceptors sense the inflammatory chemicals the body produces and send pain signals to the brain.

Common over-the-counter anti-inflammatory painkillers work by decreasing inflammation in the injured area. These are particularly useful for musculoskeletal injuries or other pain problems caused by inflammation such as arthritis.

Nonsteroidal anti-inflammatories like ibuprofen (Advil, Motrin), naproxen (Aleve) and aspirin do this by blocking an enzyme called COX that plays a key role in a biochemical cascade that produces inflammatory chemicals. Blocking the cascade decreases the amount of inflammatory chemicals, and thereby reduces the pain signals sent to the brain.

While acetaminophen (Tylenol), also known as paracetamol, doesn’t reduce inflammation as NSAIDs do, it also inhibits COX enzymes and has similar pain-reducing effects. Prescription anti-inflammatory painkillers include other COX inhibitors, corticosteroids and, more recently, drugs that target and inactivate the inflammatory chemicals themselves. Aspirin and ibuprofen work by blocking the COX enzymes that play a key role in pain-causing processes.

Because inflammatory chemicals are involved in other important physiological functions beyond just sounding the pain alarm, medications that block them will have side effects and potential health risks, including irritating the stomach lining and affecting kidney function. Over-the-counter medications are generally safe if the directions on the bottle are followed strictly.

Corticosteroids like prednisone block the inflammatory cascade early on in the process, which is probably why they are so potent in reducing inflammation. However, because all the chemicals in the cascade are present in nearly every organ system, long-term use of steroids can pose many health risks that need to be discussed with a physician before starting a treatment plan.

Topical Medications

Many topical medications target nociceptors, the specialized nerves that detect tissue damage. Local anesthetics, like lidocaine, prevent these nerves from sending electrical signals to the brain.

The protein sensors on the tips of other sensory neurons in the skin are also targets for topical painkillers. Activating these proteins can elicit particular sensations that can lessen the pain by reducing the activity of the damage-sensing nerves, like the cooling sensation of menthol or the burning sensation of capsaicin.

Because these topical medications work on the tiny nerves in the skin, they are best used for pain directly affecting the skin. For example, a shingles infection can damage the nerves in the skin, causing them to become overactive and send persistent pain signals to the brain. Silencing those nerves with topical lidocaine or an overwhelming dose of capsaicin can reduce these pain signals.

Nerve Injury Medications

Nerve injuries, most commonly from arthritis and diabetes, can cause the pain-sensing part of the nervous system to become overactive. These injuries sound the pain alarm even in the absence of tissue damage. The best painkillers in these conditions are those that dampen that alarm.

Antiepileptic drugs, such as gabapentin (Neurontin), suppress the pain-sensing system by blocking electrical signaling in the nerves. However, gabapentin can also reduce nerve activity in other parts of the nervous system, potentially leading to sleepiness and confusion.

Antidepressants, such as duloxetine and nortriptyline, are thought to work by increasing certain neurotransmitters in the spinal cord and brain involved in regulating pain pathways. But they may also alter chemical signaling in the gastrointestinal tract, leading to an upset stomach.

All these medications are prescribed by doctors.

Opioids

Opioids are chemicals found or derived from the opium poppy. One of the earliest opioids, morphine, was purified in the 1800s. Since then, medical use of opioids has expanded to include many natural and synthetic derivatives of morphine with varying potency and duration. Some common examples include codeine, tramadol, hydrocodone, oxycodone, buprenorphine and fentanyl.

Opioids decrease pain by activating the body’s endorphin system. Endorphins are a type of opioid your body naturally produces that decreases incoming signals of injury and produces feelings of euphoria – the so-called “runner’s high.” Opioids simulate the effects of endorphins by acting on similar targets in the body.

While opioids can provide strong pain relief, they are not meant for long-term use because they are addictive.

Although opioids can decrease some types of acute pain, such as after surgery, musculoskeletal injuries like a broken leg or cancer pain, they are often ineffective for neuropathic injuries and chronic pain.

Because the body uses opioid receptors in other organ systems like the gastrointestinal tract and the lungs, side effects and risks include constipation and potentially fatal suppression of breathing. Prolonged use of opioids may also lead to tolerance, where more drug is required to get the same painkilling effect. This is why opioids can be addictive and are not intended for long-term use. All opioids are controlled substances and are carefully prescribed by doctors because of these side effects and risks.

Cannabinoids

Although cannabis has received a lot of attention for its potential medical uses, there isn’t sufficient evidence available to conclude that it can effectively treat pain. Since the use of cannabis is illegal at the federal level in the U.S., high-quality clinical research funded by the federal government has been lacking.

Researchers do know that the body naturally produces endocannabinoids, a form of the chemicals in cannabis, to decrease pain perception. Cannabinoids may also reduce inflammation. Given the lack of strong clinical evidence, physicians typically don’t recommend them over FDA-approved medications.

Matching Pain to Drug

While sounding the pain alarm is important for survival, dampening the klaxon when it’s too loud or unhelpful is sometimes necessary.

No existing medication can perfectly treat pain. Matching specific types of pain to drugs that target specific pathways can improve pain relief, but even then, medications can fail to work even for people with the same condition. More research that deepens the medical field’s understanding of the pain pathways and targets in the body can help lead to more effective treatments and improved pain management.

Rebecca Seal, PhD, is an Associate Professor of Neurobiology at University of Pittsburgh Health Sciences. Benedict Alter, MD, is an Assistant Professor of Anesthesiology and Perioperative Medicine, at University of Pittsburgh Health Sciences.

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

Overdose Crisis Projected to Grow Worse in Canada

By Pat Anson, PNN Editor

Opioid-related deaths reached a record level in Canada last year and are likely to continue rising in 2022, according to a grim new report from the Public Health Agency of Canada (PHAC).

The report estimates that 7,560 people died from opioid-related overdoses in 2021, and projects that number is likely to be surpassed this year. On average, there were 21 drug deaths daily in Canada in 2021, up from eight deaths only five years earlier.

The vast majority of the deaths were linked to illicit fentanyl, a potent synthetic opioid that was often combined with other substances. Men accounted for 74% of the deaths, most them between 20 and 59 years of age.

“For many years, Canada has seen a significant rise in opioid and other substance-related deaths and harms, and this crisis continued to worsen over the course of 2021, in the midst of the COVID-19 pandemic,” Drs. Theresa Tam and Jennifer Russell, co-chairs of a PHAC Special Advisory Committee on Opioid Overdoses, said in a joint statement.

“Additionally, the vast majority of opioid-related deaths continue to be accidental, and more than half also involved the use of a stimulant (e.g., cocaine, methamphetamine), underscoring the polysubstance nature of the overdose crisis.”

Notably, only 19 percent of the deaths involved opioids manufactured by a pharmaceutical company, although the data is not broken to determine if they were bought, stolen or obtained legally through a prescription.    

The latest updated modelling projections from PHAC suggest that opioid-related deaths in Canada are likely to remain high or even increase over the next six months. Under four different scenarios, researchers think the most likely one is “Scenario 2,” in which the level of fentanyl in the drug supply remains the same, contributing to about 4,000 more deaths in the last half of 2022.

Estimated Opioid-Related Deaths in Canada

Public Health Agency of Canada

“The data contained in this release underscore the seriousness of substance-related harms in Canada, and the urgent need to take further action to help prevent them. This includes the critical need to expand access to high quality, evidence-based and innovative care to support people who use drugs,” Tam and Russell said.

Canada recently announced an experimental program that will decriminalize drug possession in British Columbia, the province hardest hit by the overdose crisis. It has also allowed the creation of safe injection sites and made heroin available by prescription.

Like Canada, the U.S. saw a record number of overdoses last year, with nearly 108,000 drug deaths. Researchers at the University of Pittsburgh say overdoses are doubling every 10 years, fueled by multiple drugs, socioeconomic inequality and social isolation.

"There are theories, but nobody has an explanation for why drug overdose deaths so consistently stick to this exponential growth pattern,” said Hawre Jalal, MD, a former professor at Pitt Public Health who is now at the University of Ottawa. "Five years ago, leaders in the drug addiction and policy fields called our findings a coincidence. We need to stop denying that this exponential growth will continue if we don't get at the root causes and fix them."

Why Untreated Pain Can Lead to Violence

By Dr. David Hanscom

I spent the first eight years of my medical practice performing surgery for back pain. Seattle, Washington in 1986 was one of the most aggressive regions in the country regarding the indications for this operation. The reason for the surge was that we were introduced to newer technology that allowed us to attain a solid spinal fusion a higher percent of the time.

I was excited to be able to offer the option of surgery to my patients and felt badly if I could not find a reason to help someone out with an operation. I followed all my patients indefinitely and worked hard on optimizing the rehab. My results seemed okay, but were not close to what I wanted them to be.

Then the data came out in 1994 that the success rate two years after a spine fusion for low back pain in an injured worker was only about 30 percent. I immediately stopped doing the procedure, but did not know what else to offer. In the meantime, I began my own descent into severe pain.

During this period, I performed a one-level lumbar fusion for a young gentleman in his early 30’s. He had a work-related injury and was in pain and disabled for over 3 years. I worked with him for about 6 months to stabilize his medications, supervised his physical therapy, and recommended several back injections. I knew nothing about chronic pain and the implications of a sensitized nervous system.

After the operation, he was worse. I saw him every two to four weeks for over a year to do what I could to help him. He became increasingly frustrated, and his behavior became so aggressive, I had to dismiss him from care. He quickly assaulted his grandmother for money for meds. He then headed with a gun to Eastern Washington, where I was holding a satellite clinic.

“He’s coming after you with a gun,” a relative warned. We alerted the police and fortunately he never showed up. I never heard from him again.

Around this time, one of my spine partner’s patients begin to scream and yell in the middle of a full waiting room because he had a failed spine surgery and his disability had run out. He proceeded to pick up a potted plant and throw it across the room. Fortunately, no one was injured.

Spine Surgeon Killed

Dr. Preston Phillips was a spine surgeon who was shot and killed a few weeks ago in Tulsa, Oklahoma by a patient who was angry about his post-operative pain. Phillips was a colleague of mine in Seattle. I did not know him well, but interacted with him in conferences and some patient care. He was as nice a person as I have ever worked with.

It may be easy to blame Phillips for doing a surgery that apparently failed, but it is not his fault. His patient had chronic back pain and almost none of us in medicine are trained to treat it effectively, in spite of the data being right in front of us for decades. We are treating almost all symptoms and disease from a structural perspective, when most of them arise from the body’s physiological state of being in a sustained “flight or fight” response.

Phillips was doing what he was trained to do with the best of intentions. His patient was trapped in an endless cycle of pain and surgery is often viewed as the definitive answer. It requires enduring even more pain and anxiety, so the level of disappointment is even higher when surgery fails.

The Abyss

One afternoon, I was listening to a patient attempting to describe the depth of her suffering and it hit me how deep and hopeless this hole of chronic pain is for most people. I realized that words were inadequate to encapsulate their degree of misery. Since no one seemed to have any answers, there was no apparent way out. The description that seemed to fit for this dark, bottomless pit was “The Abyss.”

A 2007 research paper documented that the effect of chronic pain on one’s life is similar to the impact of having terminal cancer. With cancer, you at least know the diagnosis and that there is an endpoint, one way or the other.

Suffering from terminal cancer is horrible, but living with constant pain without a cure, treatment or endpoint is even worse. Here are just a few of the ways:

• You have been told that there is nothing wrong and you have to live with your pain the best you can. The reality is that there is a physiological explanation for all of it.

• You may have been given the diagnosis of “Medically Unexplained Symptoms.” This is simply not true based on the last 20 years of basic science research.

• You are labeled by almost everyone, including the medical profession. The labels include drug seeker, malingerer, lazy, unmotivated, making things up, and not tough enough. The list is endless.

When you are trapped by anything, especially pain, your frustration and anger is deep and powerful. This scenario creates an even more intense flight or fight response. The blood supply to your brain shifts from the thinking center to the survival midbrain, and your behaviors may become irrational. There does not seem to be way out and you lose hope.

The literature also shows that pain is often worsened when surgery is performed in the presence of untreated chronic pain. I was also not aware of that data until after I quit my surgical practice. For Phillips’ patient to act out the way he did is unacceptable, but being trapped causes people to act irrationally.

Anger is not only destructive; it can be self-destructive. Suicide is problematic in patients suffering from relentless pain. For many, it seems to be the only way out. I was also at that point towards the end of my pain ordeal.

Physical therapy, chiropractic adjustments, injections, acupuncture, vocational retraining, medications, traction, inversion tables, and finally surgery. How many times can your expectations be dashed before you lose hope?

All the parties in the Tulsa shooting were victims of the business of medicine, and I put the blame squarely on its shoulders. Physicians are inadequately trained in chronic pain and data-based effective treatments are not usually covered by insurance. Physicians are often rushed, don’t have time to talk to patients, and their patients don’t feel heard. These are just some of the variables, but the energy is all aimed in the same direction: Money.

There are real solutions for your pain. Learning to calm and redirect your nervous system out of a threat state is a learned set of well-documented interventions. These techniques are not particularly profitable, but that is not the primary reason I went into medicine.

Both the medical profession and patients are going to have to demand a change in the paradigm of treating people. The first step being that you need to be heard and that takes time. It needs to happen soon.

David Hanscom, MD, is a retired spinal surgeon who has helped hundreds of back pain sufferers by teaching them how to calm their central nervous systems without the use of drugs or surgery.

Hanscom has a website called The DOC Journey, in which he shares his own experience with chronic pain and offers patients a pathway out of mental and physical pain through mindful awareness and meditation.

He is the author of “Do You Really Need Spine Surgery?” and “Back in Control.”

Kolodny Returns as PROP President

By Pat Anson, PNN Editor

After an eight-year hiatus, much of it spent testifying as a paid expert witness in opioid litigation trials, Andrew Kolodny, MD, has been reappointed as president of Physicians for Responsible Opioid Prescribing (PROP), the anti-opioid activist group that he founded. Kolodny succeeds Dr. Jane Ballantyne, who remains with the organization as VP for Clinical Affairs.

“I am delighted to serve in this role again, especially at a time when the need for more cautious opioid prescribing in the United States and abroad is becoming increasingly clear to clinicians, policymakers and the public,” Kolodny said in a press release.

Kolodny served as PROP’s first president from 2010 until 2014, when he was Chief Medical Officer at Phoenix House, a nationwide chain of addiction treatment centers. He is currently the Medical Director of Opioid Policy Research at Brandeis University.

Although Kolodny is a psychiatrist with a background in addiction treatment and lacks expertise in pain management, he has played a prominent role in reducing the use of opioids to treat pain. He lobbied Congress and federal health agencies for years to limit opioid prescribing, and is often quoted making sensational anti-opioid comments in the media, calling them “heroin pills” or saying that over-the counter drugs like ibuprofen “are as effective and in some cases more effective than opioids.”   

He stopped talking to this reporter years ago, saying he doesn’t like my questions and hasn’t had “a good experience” answering them.

Paid Expert Witness

Kolodny’s reinstatement as PROP’s president comes at a time when many opioid litigation cases are wrapping up against drug manufacturers and distributors, resulting in multi-billion dollar settlements with states, cities and counties. The plaintiff law firms who filed and pursued those cases stand to make billions of dollars themselves in contingency fees.

Kolodny was a paid expert witness or consultant for at least four of those law firms (Motley Rice, Nix Patterson, Cohen Milstein and Scott & Scott), making as much as $500,000 when he testified at a rate of $725 an hour in Oklahoma’s lawsuit against Johnson & Johnson.

That case, which resulted in a $425 million verdict against the drug maker, was overturned last year by Oklahoma’s Supreme Court, which ruled that J&J was not the “public nuisance” that Kolodny and the state attorney general portrayed it to be.  

A similar ruling was made by a California judge, who said opioid manufacturers did not use deceptive marketing and were not liable for the state’s opioid crisis. Dr. Anna Lembke, a Stanford psychiatrist and PROP board member, testified as a paid witness for plaintiffs in that case, but Judge Peter Wilson said her testimony about opioid addiction was unreliable.

DR. ANDREW KOLODNY

Court records show that Lembke was paid up to $800 an hour for her testimony in a New York opioid litigation case.

Public records also show that Kolodny was hired as an “expert consultant” by at least one state. In 2020, he signed a contract with the New York State Department of Financial Services to provide “consultation on medical issues and trends regarding the prescription of opioids” at a rate of $600 an hour. In one invoice, Kolodny billed the state $1,500 for making two phone calls. The maximum amount to be paid to Kolodny was later set at $174,999.

In addition to Kolodny and Lembke, at least five other PROP board members have testified as paid expert witnesses or consultants in opioid litigation: Ballantyne, Dr. Danesh Mazloomdoost, Dr. Adriane Fugh-Berman, Dr. Mark Sullivan and Dr. David Juurlink. Mazloomdoost was paid a rate of $850 an hour for his testimony.

PROP members have failed on repeated occasions to disclose these business relationships, but when questions were raised about them, they filed revised conflict of interest statements — without providing details on who they worked for or the amount they were paid.

PROP itself has not been transparent about its finances. PROP is not a public charity and has never filed a tax return. It takes advantage of a loophole in IRS law by having the Steve Rummler Hope Foundation as its “fiscal sponsor,” which allows donors to make tax-deductible donations anonymously.

PROP says it does not accept funding from “pharmaceutical companies and other life sciences corporations.” Kat Marriott, PROP’s Executive Director, did not respond to an email asking if the organization accepted money from law firms, medical device makers, drug testing companies or other industries that have profited from the opioid crisis.  

(Update: This story contains several updates relating to PROP members working as paid expert witnesses and consultants in opioid litigation cases. )

Advocacy and Awareness Should Promote Healing, Not Division

By Mia Maysack, PNN Columnist

June is Migraine and Headache Awareness Month in the United States. This year’s theme is “Advocate for Access.” 

Although I understand the intent behind awareness months, to those of us who truly live with a non-stop condition, they can border on being a tad mundane. Especially when the execution of the awareness itself does very little to propel us forward in any meaningful way.

I live with deeply rooted and untreatable nerve damage from an incurable traumatic brain injury. Bacterial meningitis almost claimed my life as a child. My brain swelled up and still feels pained and swollen even now -- the very definition of intractable pain.  Because migraines are literally my each and every day reality, I'm sick and tired of focusing on or talking about them. 

From what I've witnessed, awareness campaigns are often a repetition of the same conversations, among the same people and within the same circles. We as "migraineurs" don't need to continuously hear about what we already know. In my opinion, it's an unnecessary use of precious energy and the impact doesn't go as far as it could. 

The "pain community" generally seems less of a community and more like a clique -- a repeated line up of only certain people’s voices being heard and a select few being invited to participate in events.  

It gets even worse than that:  I recall emerging onto the pain scene out of an absolute last resort. I jumped head first into involvement with every organization I could find and joined several support groups out of sheer desperation. One day, a routine migraine treatment with Botox went horribly awry -- to the point I still deal with the repercussions to this day. 

I immediately logged on to share this experience, not in an attempt to scare anyone but to raise awareness and hopefully assist in others not encountering the same thing I did. I hoped for some compassionate empathy but what I received was the exact opposite. 

I was torn to shreds online by keyboard warriors claiming not to feel well enough to physically function, but clearly energized to the point of dragging me down. Before I was given a chance to clarify or further explain, I was muted by administrators. This felt violent, uncalled for and oppressive. I was bullied and shunned at a point in time I couldn’t afford to be. 

These very same individuals have the audacity and nerve to schedule days of remembrance for those who could no longer accept or deal with their pain, while simultaneously playing an active role in pushing people over their edge, probably without even caring or realizing it. 

I view it as a sickness, that a person would demand and expect consideration and respect when they don't demonstrate or possess it for others. It's a contest of underlying comparison as well as competitive victimization: I've hurt longer than you, worse than you, my life has been harder than yours, and no one else's life is as bad as mine.  

Is that really a game you want to win? How could one ever expect to feel better with a fixation like that? 

I've come to realize that many who claim to want improvement aren't truly committed to it. It takes work, a retraining of our minds and an entirely new approach to not only how we care for ourselves, but how we care for others.  

This questionable code of conduct is an illness in itself. The resistance to actual improvement is in part what's keeping members of these groups sick -- not to mention the fact that some remain utterly attached to their conditions to the point they're unsure of any identity outside of them. If those they so faithfully follow were truly interested in the well-being of their devoted followers, they'd be attempting to shine a light on the darkness as opposed to benefiting or profiting from it. 

I remained quiet on this for a long time, but one thing about my advocacy is that it’s real. Some people love that and others hate it. I’m not afraid to burn bridges, especially the ones that I built. In case you haven’t noticed, the whole world is hurting and the healing of our planet is what matters. Not just you and your cause.   

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

Ice Packs and Tylenol: Why a New Study on Post-Operative Pain Falls Flat

By Pat Anson, PNN Editor

The prescribing of opioids to patients recovering from surgery is a hot topic these days. Fearing that patients may become addicted, a growing number of U.S. hospitals now send their surgery patients home with non-opioid analgesics like Tylenol. According to a recent study, the number of opioid pills prescribed to patients for post-operative pain has been cut in half since 2017.

Reducing the use of opioids has led to complaints from patients that their post-operative pain is poorly treated. It may have even led to a tragic mass shooting. Police say the patient who killed four people – including his surgeon – at a Tulsa hospital this month was angry about “the ongoing pain that came from the surgery” he had 13 days earlier.

A new study by researchers at McGill University in Montreal is likely to add further fuel to the debate over opioids. In a meta-analysis of 47 clinical trials – a study of studies – researchers concluded that opioids don’t work well for post-operative pain, and cause more harm than good.

“The study results indicate that prescribing opioids to manage postoperative pain after discharge is not only unnecessary, but harmful in many surgical settings. These findings… fill a critical gap in knowledge about how pain should be managed at home after surgery,” is how a McGill University press release summarized the findings.

It’s important to read the fine print here. The McGill study, published in The Lancet, has three major limitations that the press release either ignores or downplays.

First, most of the clinical trials that were studied were for dental procedures such as tooth extractions or for minor surgeries conducted in a physician’s office, such as removal of a skin lesion. None of the surgeries involved patients having major operations in a hospital, such as a cesarean section or appendectomy.

Second, much of the data was “largely derived from low-quality trials,” according to the authors.

Third, the primary goal of the study was to assess the pain relief provided by opioids and non-opioid analgesics for one day -- “on day 1 after discharge” – which hardly fills the “critical gap in knowledge” about post-operative pain that McGill claims to have been filled. What about the next 5 or 10 days a patient might need to recover from surgery? What about 13 days?

Despite these glaring limits on the quality of their analysis, McGill researchers came to some broad conclusions.

"We found that prescribing opioids had no impact on patient-reported postoperative pain compared to simple over-the-counter analgesics, but it significantly increased the risk of adverse events, such as nausea, vomiting, constipation, dizziness and drowsiness," said lead author Julio Fiore Jr., PhD, a non-practicing “surgical scientist” at McGill University Health Centre.

"Prescribing opioid-free analgesia may prevent these adverse effects, improve patients' recovery experience, and also help mitigate the opioid crisis by reducing the risk of postoperative opioid misuse, addiction and diversion."

Study Methodology Questioned

But critics of the study’s methodology point out that most patients had only modest pain scores and received very low doses of opioids. The median daily dose of 27 morphine milligram equivalents (MME) is far below cautionary levels recommended by the CDC — and hardly reflective of what a patient might need after a major surgery.

“Most of the surgeries were minor and probably required minimal post-op analgesia,” said Stephen Nadeau, MD, a professor of Neurology at the University of Florida College of Medicine. “In short, the generalization of their findings to all opioid treatment of post-operative pain goes far beyond what the data will support. The reviewers and Lancet editor should have taken them to task about this.”

Over $80,000 in taxpayer funding for the McGill study came from the Canadian Institutes of Health Research, which is Canada's federal agency for healthcare research.

“This is typical of the research that we have seen from Canadian researchers that have put Canadians in such a bad state. Their methods and reasons are suspect and the use of data mining continues to come up with false premises,” said Barry Ulmer, Executive Director of the Chronic Pain Association of Canada. “It is shocking and McGill should be ashamed, as should The Lancet. What is also shocking is the Canadian government continues to fund many of these over the wall studies.”

In a preview of the McGill study published in 2020, Fiore and his colleagues said they would exclude from their analysis any studies that evaluated the effectiveness of analgesia for chronic postoperative pain. In other words, they excluded studies of pain relievers that had outcomes running counter to their narrative. If a surgery patient developed chronic pain after their acute pain was only treated with Tylenol, they didn’t want to hear about it.   

"The quality of the selected studies was variable, and none of them addressed non-opioid analgesia during discharge from major or major-complex surgery," acknowledged co-author Charbel El-Kefraoui, a non-practicing “research trainee” at McGill University. "It will therefore be important to conduct studies on different surgical procedures and on different postoperative pain management regimens, including pharmacologic and non-pharmacologic interventions like expectation setting, relaxation and ice packs."

Good luck with that. Ice packs and Tylenol are probably a good way to recover from a toothache, which is basically what the McGill study looked at. They are not a good way to treat acute pain from a major surgery. Or a way to avoid future tragedies like the one in Tulsa.

Low-Dose Cannabis Inhaler Effective in Treating Chronic Pain

By Pat Anson, PNN Editor

Low-doses of medical cannabis delivered through an inhaler significantly reduced pain in patients with neuropathy, back pain and other chronic pain conditions, according to a new study.

Researchers assessed the efficacy of vaporized cannabis in 138 pain patients using the Syqe Inhaler, a pocket-sized device that delivers microdoses of aerosolized cannabis. The study was funded and conducted by Syqe Medical, a medical technology company in Israel that makes the inhaler.

Unlike smoking or traditional vaping, the Syqe inhaler heats the cannabis to a temperature below combustion and uses airflow controls to deliver precise doses of cannabis to the patient's lungs in less than 2 seconds. The mean dose in the study was 1.5 mg of aerosolized delta-9-THC, a fraction of what a typical cannabis user would get from a joint or vaporizer.

Participants in the study used the inhaler up to several times a day, depending on need, and were followed for up to a year.

The study findings, published in the journal Pain Reports, show that pain levels fell from an average of 7.3 (on a zero to 10 pain scale) to 5.5 after 120 days – a reduction of nearly 23 percent. For patients in severe pain, pain levels dropped over 28 percent.

Most participants also reported significant improvement in their quality of life, with 92% saying their lives were “better” or “much better.”  

Of the 43 patients who were using opioid pain medication at the start of the study, 58% reported using lower doses after initiating treatment with the inhaler.

Adverse events, such as dizziness and headache, were minor and usually lasted only a few minutes. About 17% of patients reported no decrease in pain intensity and 7% reported more pain.

SYQE MEDICAL IMAGE

“Medical cannabis treatment with the Syqe Inhaler demonstrated overall long-term pain reduction, quality of life improvement, and opioid-sparing effect in a cohort of patients with chronic pain, using just a fraction of the amount of MC (medical cannabis) compared with other modes of delivery by inhalation,” researchers reported.

“These outcomes were accompanied by a lower rate of AEs (adverse events) and almost no AE reports during a long-term steady-state follow-up. Additional follow-up in a larger population is warranted to corroborate our findings.”

The Syqe Inhaler is currently only available in Israel and Australia. The company said in an email that it plans to launch the device in Canada and New Zealand in the coming months. No timetable was offered on its availability in the United States.

“We believe it is our responsibility to reduce the pain and suffering of as many patients as possible in the fastest possible way, and we are determined to make medical cannabis treatment a standard of care utilizing advanced technologies,” said Sharon Cohen of Syqe’s Customer Experience Team.

Walking Reduces Pain From Knee Osteoarthritis

By Pat Anson, PNN Editor

It may seem counterintuitive, but a new study suggests that walking may be the best medicine to reduce knee pain from osteoarthritis.

Nearly 40 percent of Americans over the age of 45 have some degree of knee osteoarthritis, a progressive joint disorder caused by inflammation of soft tissue, which leads to thinning of cartilage and joint damage. Osteoarthritis (OA) of the knee is not to be taken lightly, as studies have found that it is strongly associated with early death, high blood pressure, diabetes, elevated cholesterol and cardiovascular disease, particularly for women.

Moderate exercise like walking may help prevent all of those health problems.

In a multi-year study of 1,212 people over the age of 50, researchers at Baylor College of Medicine found that participants who walked for exercise at least 10 times had 40% less risk of developing frequent knee pain than non-walkers.

“Until this finding, there has been a lack of credible treatments that provide benefit for both limiting damage and pain in osteoarthritis,” said Grace Hsiao-Wei Lo, MD, assistant professor of Immunology, Allergy and Rheumatology at Baylor and lead author of the study published in Arthritis & Rheumatology.

“These findings are particularly useful for people who have radiographic evidence of osteoarthritis but don’t have pain every day in their knees,” Lo explained in a press release. “This study supports the possibility that walking for exercise can help to prevent the onset of daily knee pain.  It might also slow down the worsening of damage inside the joint from osteoarthritis.”  

Lo says walking for exercise has other health benefits, such as improved cardiovascular health and decreased risk of obesity, diabetes and even some cancers. Walking is also a free activity with minimal side effects.

“People diagnosed with knee osteoarthritis should walk for exercise, particularly if they do not have daily knee pain,” says Lo, who is chief of rheumatology at the Michael E. DeBakey VA Medical Center in Houston. "If you already have daily knee pain, there still might be a benefit, especially if you have the kind of arthritis where your knees are bow-legged.”

Avoiding Opioids During Surgery May Harm Patients

By Pat Anson, PNN Editor

Many U.S. hospitals have adopted policies that reduce or even eliminate the use of opioids during surgery, with the goal of lowering the risk of a patient later becoming addicted. That has resulted in greater use of spinal anesthesia as a substitute for general anesthesia.

During spinal anesthesia, non-opioid medications are used to numb the lower part of the body through an injection into the spinal column. During general anesthesia, a combination of opioids and other analgesics are administered intravenously or through a breathing tube to sedate patients.

But a large new study suggests that spinal anesthesia may actually increase the use of prescription opioids – at least when it comes to hip fracture surgeries.

In an analysis of 1,600 patients who had surgery to repair hip fractures, researchers at the University of Pennsylvania Perelman School of Medicine found that patients who received spinal anesthesia reported more pain in the 24 hours after surgery than those who receive general anesthesia. They were also more likely to be using prescription opioids 60 days after surgery.

“In our study, patients who got spinal anesthesia did get fewer opioids in the operating room, but they ended up having more pain, and more prescription pain medication use after surgery,” said lead author Mark Neuman, MD, an associate professor of Anesthesiology and past chair of the Penn Medicine Opioid Task Force.

“While our study can’t determine conclusively whether this was due to the spinal anesthesia itself or the fact that fewer opioids were given up front, this is a result that should make people examine some of the assumptions informing current care pathways.”

The study findings, published this week in The Annals of Internal Medicine, show patients had their worst pain the day after surgery. Spinal anesthesia patients rated their pain an average of 7.9 (on a zero to 10 pain scale), slightly higher than the average of 7.6 reported by those under general anesthesia.

Researchers say 25 percent of patients in the spinal anesthesia group were using prescription opioids 60 days after surgery, compared to 18.8 percent of patients in the general anesthesia group. There were no significant differences in prescription pain medicine use after six and 12 months, but Neuman is wary of what he saw.

“Even though the 180- and 365-day findings are not statistically significant, the 60-day finding is still concerning, since there could be medication-related harms like respiratory depression or over-sedation that could still occur over the short term,” Neuman said.

Neuman and his colleagues found no significant differences in patient satisfaction, pain levels or mental health status after 60, 180 or 365 days between the spinal anesthesia and general anesthesia groups.

More than 250,000 older Americans suffer hip fractures every year and nearly all are repaired through surgery. In the past, most would receive general anesthesia, but in recent years the use of spinal anesthesia has increased significantly, due in part to the belief by some anesthesiologists that it was safer for frail, older patients.  

Elimination of Opioids Has “Unintended Safety Risks’

There is a growing reluctance on the part of surgeons to eliminate the use of opioid anesthesia or to allow patients to opt out of opioids during surgery.

In an op/ed recently published in The Conversation, three physicians at the University of Michigan Medical School called opioid medication “an essential tool in the operating room.”  

“Opioids stand out among the typical sedatives and anesthetics used in the operating room by significantly reducing the amount of other drugs needed to achieve pain relief, sedation and loss of consciousness,” wrote Drs. Mark Bicket, Jennifer Waljee and Paul Hilliard. 

“Whether or not patients receive opioids during surgery doesn’t affect how likely they are to continue using opioids or receive an opioid prescription afterward. We believe that wholesale elimination of opioids without considering the unique setting of the operating room may lead to unintended safety risks for patients. A more nuanced care plan that relies on reduced amounts of opioids could set patients up for a faster recovery with fewer side effects and better outcomes after surgery.”  

Seven states currently allow patients to sign non-opioid directives telling their physicians not to treat them with opioids. Congress is considering bills in the House and Senate that would allow patients to make similar directives nationwide. Although both bills allow providers to override a patient’s directive in special circumstances, Bicket, Waljee and Hilliard are concerned the directives will lead to unsafe care.

“We have seen medical practice shift from embracing opioids to eliminating them altogether. We believe that opioids serve an essential tool in the operating room for many patients, and avoiding them for certain cases can make it difficult if not impossible to avoid harming patients,” they wrote.

Tips to Make Traveling Less Painful

By Victoria Reed, PNN Columnist

Now that summer is right around the corner, many people like to take a vacation to relax and enjoy the nice summer weather. Summer is my favorite season because I live in northeast Ohio, where the winters can be very cold and snowy. As someone who lives with chronic pain, having to go out in the blistering cold and navigate snow covered roads can make life even harder.

Recently I took a flight to California to attend a family member’s college graduation. It was a fairly long trip, lasting more than five hours. I’ve made trips to California from Ohio many times over the course of several decades. But over the years, as the comfort of riding on airplanes has diminished and as my back, joints and muscles have gotten sorer, the flight turned out to be less than pleasant. 

People in pain often have more to carry than the average person, and diabetics like me need to bring more medical supplies. I try to keep my carry-on backpack light, especially since rheumatoid arthritis (RA) has ravaged my shoulders, which frequently hurt.

Of course, I want to be comfortable when flying, so I regularly pack things such as a neck pillow and a blanket or two. In addition, I must bring snacks, prescription medications, a blood glucose testing kit, a small portable cooler and ice pack for my insulin, several insulin pens, and wrist braces for the inevitable in-flight RA flare. Add to that the standard personal items that I usually carry in my purse. I also like to bring my iPad (with noise canceling headphones) for entertainment.

Because of these necessities (and the not-so-necessary iPad), the backpack was quite heavy. By the time I arrived at my rental home-away-from-home with my dog, I was having a full-blown flare that involved joint pain, muscle pain and severe fatigue. 

I still needed to get some groceries, and after doing that and settling comfortably in bed, a sobering thought came to me: I can’t do this alone anymore.

The fact is, it has become too hard and exhausting. I love traveling, but airline travel is not what it was years ago. It used to be exciting to get on a plane, settle in a window seat and experience the beauty of being above the clouds and watching the mountains below them. But now airplanes are packed so tightly that there’s no room to be comfortable.  I try to book an aisle seat so that I have room to at least stretch my legs and get up to use the restroom without disturbing anyone.

Regardless, I would like to continue traveling because I love going to new places and exploring the beautiful United States. When the pandemic first became a thing, my husband and I purchased a camper, and we began taking trips to national and state parks with our dogs. It quickly became our preferred way of travel.

Because airline travel can be especially stressful for those of us with chronic illness, I recommend traveling by car or RV (if you can afford one). It is so much easier when you have everything you need in one place and are able to stop and stretch when you need to.

Also, if you need to take medications during your trip, they are easier to access than trying to get into your bag in an overhead bin or struggling to reach under the cramped airline seat. Road travel is also the best way for your pets to travel. Pets can be a great source of comfort to those suffering with pain.

However, if you must travel by airplane or just prefer to, there are things you can do to make it more comfortable. I recommend bringing items such as a blanket and a travel pillow. Wear comfortable shoes that can easily be taken off during the security process. Bring along a hoodie or sweater, as the plane tends to get chilly during the flight.

If you have severe mobility issues, arrange to have a wheelchair waiting at the airport or use one of the transport carts to get you to your gate. Pack some healthy snacks, as the ones they serve during the flight are very minimal and not very healthy. If you are a diabetic, pack some candy for those possible blood sugar lows. That way you don’t have to wait for the flight attendant with the drink cart containing sugary drinks.

If you have low back issues, bring an additional light banket to roll up and place behind your back. That could make a world of difference in your comfort level.

If you are traveling onboard with a pet, try to have a companion with you to assist. Having to carry the pet increases the load you already have to manage, and you lose the under-seat space where your purse or backpack is placed. Since many people bring their roller bags onboard, instead of checking them, trying to find overhead space for your personal bag is…well, trying!

Traveling these days can be a challenging experience, but it’s even more so for chronic pain sufferers. Taking a nice vacation or a weekend trip somewhere (if you can afford to) can be just what you need to relax, rejuvenate, boost your mood, and be a distraction from daily pain. With a little advanced planning, you can prevent it from becoming a miserable experience.

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

Opioid Tapering Raises Risk of Overdose and Mental Health Crisis

By Pat Anson, PNN Editor

Tapering patients to lower doses of opioid pain medication significantly raises the risk of opioid withdrawal, drug overdose and a mental health crisis such as depression, anxiety or suicide attempt, according to a large new study. For most patients, the risk remains elevated up to two years after their doses were reduced.

Opioid prescribing has fallen dramatically in the United States over the past decade, particularly after the release of the CDC’s controversial opioid guideline in 2016. Although millions of patients were affected, few efforts were made to study patient outcomes or what happens to those who have their opioid doses reduced or even stopped.

To address this knowledge gap, researchers at the University of California Davis School of Medicine analyzed health data for over 19,300 patients on long-term opioid therapy who had their doses reduced by at least 15 percent. In addition to medical and pharmacy claims, researchers looked at emergency room visits and hospital admissions for overdose, withdrawal or mental health crisis, both before and after tapering.

"We used an innovative observational study design to understand the patients' experience before and after opioid dose reduction. We compared outcome rates in pre- and post-taper periods with patients serving as their own controls," said co-author Daniel Tancredi, PhD, a pediatrics professor at UC Davis Health.

"While patients may struggle during the early tapering period, we reasoned that many may stabilize with longer-term follow-up and have lower rates of overdose and mental health crisis once a lower opioid dose is achieved," said lead author Joshua Fenton, MD, professor and vice chair of research at UC Davis School of Medicine.

But Fenton and his colleagues found patients continued to struggle long after their doses were cut. Their findings, published in JAMA Network Open, show a 57% increase in overdose or withdrawal incidents and a 52% increase in mental health crises 12 to 24 months after doses were lowered.

For every 100 patients during pre-tapering, there was an average of 3.5 overdose or withdrawal events and 3 mental health crises. After tapering, there were 5.4 overdose/withdrawal events and 4.4 mental health crises for every 100 patients. The risks associated with tapering were greatest in patients with the highest doses.

"Our findings suggest that, for most tapering patients, elevated risks of overdose and mental health crisis persist for up to two years after taper initiation," said Fenton. "We hope this work will inform a more cautious approach to decisions around opioid dose tapering."

An earlier study at UC Davis found that tapered patients were 68% more likely to be treated at a hospital for opioid withdrawal, overdose or alcohol intoxication, and were twice as likely to have a mental health crisis.

‘I Was Cut Off Cold Turkey’

The FDA warned in 2019 that rapid tapering or abrupt discontinuation was causing serious harm to patients. The CDC Director also pledged that year to evaluate the impact of the agency’s opioid guideline on patients and to “clarify its recommendations.”

Three years later, not a word of the CDC guideline has changed and the agency is slow walking efforts to revise it. A revised guideline draft, which cautions doctors to avoid rapid tapering or discontinuation, is not expected to be finalized until late this year. In the meantime, many doctors continue to taper patients – even those who’ve taken opioids safely and responsibly for years.

“Yesterday, I was cut off of one of my opioid medications, cold turkey. I've been given one last 30-day supply of the other, after 19 years of chronic pain treatment with opioid medication. I am bedridden,” a patient told us in a recent PNN survey on the impact of the 2016 guideline.

“Currently my pain management doctor is tapering everyone from schedule II (opioid) medications, even with years of good results and no side effects. This is dangerous when people are dealing with real pain,” said another patient.

“Before the guidelines, my pain was controlled with fentanyl patches and Vicodin for breakthrough pain. I was able to work, care for my home and family. That's all been taken away and now I spend my time either in bed or on my couch, in pain. Tapering down was 7 months of hell in my bedroom. It was cruel and unnecessary to take away medicine that allowed me to enjoy and participate in my life,” another patient wrote.

In an editorial also published in JAMA Network Open, two University of Alabama at Birmingham researchers who are studying the role of tapering in patient suicides urged doctors to be more cautious.

“Our view is that opioid dose reduction is likely to offer benefit for some, while harming others. The harms may include worsening pain, distress, or death,” wrote Stefan Kertesz, MD, and Allyson Varley, PhD. “Given this uncertain balance of harm and benefit, it would be wise for health systems to stop promoting this change to care. A policy of tapering all patients to doses lower than a specified threshold cannot be supported from available evidence.”

Kertesz and Varley are currently recruiting family and friends of patients who died by suicide to participate in a pilot study about the impact of opioid tapering on their loved ones. To participate in their study, click here to take an online survey or call 1-866-283-7223.

FTC Sues Footwear Company Over Pain Relief Claims

By Pat Anson, PNN Editor

The U.S. Federal Trade Commission has filed a lawsuit against a California footwear company, alleging it makes false claims that its shoes can relieve knee, back and foot pain. It’s the latest salvo in a long-running legal battle between the FTC and the Gravity Defyer Medical Technology Corporation.

According to the FTC complaint, Gravity Defyer and its owner, Alexander Elnekaveh, violated a 2001 order barring him from using deceptive advertising that makes unsupported scientific claims. The FTC says the company’s ads target people aged 55 and older, telling them its “pain defying footwear” made with “hybrid VersoShock technology” can relieve suffering from arthritis, joint pain, plantar fasciitis and heel spurs.

“Ignoring a prior Commission order, Gravity Defyer and its owner used false pain-relief claims to target older Americans and undercut honest competitors,” Samuel Levine, Director of the FTC’s Bureau of Consumer Protection, said in a statement. “Health-based claims require science-based proof, and faking it by misusing studies and customer reviews breaks the law.”

The 2001 FTC order stems from another company operated by Elnekave, which sold a magnetic fuel-line device that allegedly could reduce gasoline consumption by as much as 27 percent. The FTC says those claims were false and misleading.

Gravity Defyer sells an expensive line of athletic shoes, casual shoes, dress shoes, hiking shoes, boots and sandals for men and women.

They range in price from $140 for a pair of sandals to $235 for work boots.

The company sells the shoes on its website, Amazon and at retailers around the country, including The Walking Company, Hammacher Schlemmer, and Shoe City. It advertises its products on Arthritis Today and WebMD, as well as numerous other publications and websites.

Asked to comment on the FTC complaint, the company sent a statement to PNN claiming that its First Amendment right to free speech was being violated.

GRAVITY DEFYER AD

“Gravity Defyer apprised the FTC of the obvious logical flaws in its stance – and that its stance violates Gravity Defyer’s First Amendment right to disseminate, and consumers’ right to receive, truthful, non-misleading scientific information. The FTC was unrelenting in its strange position,” the company said.

In April, Gravity Defyer filed a lawsuit of its own against the FTC. Much of it hinges on a small 2017 study that the company has long used to justify its pain-relieving claims. The study, recently published the Journal of the American Podiatric Association, found that Gravity Defyer’s “shock-absorbing sole” reduces knee pain an average of 85 percent, significantly better than traditional soles.

The FTC says the study has “substantial flaws” because of its small size (52 participants) and duration (5 weeks), and because it relied on participants’ self-reported pain levels.

“It was also only designed to measure knee pain. Thus, the study was not sufficient to determine the effects of wearing Gravity Defyer’s footwear on knee, back, ankle or foot pain, or pain associated with the specific conditions claimed,” the FTC said.

The Commission, which voted 4-0 to file the complaint, is seeking an order permanently barring Gravity Defyer and Elnekaveh from making misleading or deceptive pain-relief claims, as well as civil penalties.