FDA Approved Genetic Test for Opioid Use Disorder Is Flawed

By Crystal Lindell

An FDA-approved test that claims it can identify genetic risk for opioid use disorder (OUD) is so flawed as to basically be useless – at least according to a new study published in JAMA.

The genetic test, which is sold under the brand name “AvertD” by AutoGenomics, was given approval by the Food and Drug Administration in 2023. The test claims it can use 15 genetic variants to identify people at risk for misusing opioids. 

According to AutoGenomics, the variants “may be associated with an elevated genetic risk for developing OUD.” However, the company provides no citations to support the associations between the brain reward pathways and OUD — meaning the test’s foundation itself seems to be flawed.

However, the authors took the premise of the AvertD test seriously, and set out to find if it could actually predict OUD. They looked at a diverse sample of more than 450,000 “opioid-exposed individuals” (including 33,669 individuals with OUD), and found no evidence to support the use of the AvertD test. 

Specifically, they found both high rates of false positives and false negatives, with 47 out of 100 predicated cases or controls being incorrect. 

“Notably, clinicians could better predict OUD risk using an individual’s age and sex than the 15 genetic variants,” researchers said.

The fact that the test doesn’t seem to work could have dangerous consequences for pain patients. The fear is that they will be used to deny patients opioid medications simply because their “genetic markers” show them to be in a high-risk patient group. 

The study authors directly point this out, writing: “False-positive findings can contribute to stigma, cause patients undue concern, and bias health care decisions.”

They also point out the potential harms of a false-negative finding, which "could give patients and prescribers a false sense of security regarding opioid use and lead to inadequate treatment plans."

The fact that this genetic test has gotten as far as it has raises questions about the FDA approval process. 

The problems don’t stop there though. Another major flaw in both the study and the genetic testing is that “Opioid Use Disorder” has such murky diagnostic criteria, that it’s difficult to take it seriously. It’s basically a set of vague symptoms, as opposed to a clear-cut diagnosis, despite what some have been led to believe. 

A CDC fact sheet for OUD Diagnostic Criteria is a mishmash of vague symptoms, such as tolerance and withdrawal, that could just be the result of untreated or poorly treated physical pain. 

Things like “taking opioids in larger amounts or over a longer period of time than intended” and “having a persistent desire or unsuccessful attempts to reduce or control opioid use.”

The CDC also lists "withdrawal symptoms" as one of the diagnostic criteria for OUD, which is something that people can experience from rapid tapering without having OUD.

The CDC then includes the odd disclaimer that “tolerance and withdrawal are not considered” when opioids are taken under appropriate medical supervision.

So in a country that does not guarantee healthcare, you can avoid an OUD diagnosis if you can afford to find a doctor willing to prescribe opioids to you. But if you can’t find a doctor or abandoned by one — and then have withdrawal symptoms — you must have a disorder.

That doesn’t sound like a medical diagnosis to me. That sounds like classism.

A patient needs just to have just two of the OUD criteria to have “mild OUD” – a benchmark that has the sweeping effect of including a large number of patients taking opioids for chronic pain. 

It’s no wonder that a genetic test claiming to be able to predict OUD would be so flawed, given how flawed the diagnosis of OUD is to begin with. 

Perhaps instead of trying to guess potential risks for a vague disorder, the FDA should be focused on treatments already proven effective for people who want to stop their opioid use, like expanding methadone access. 

The whole situation reminds me of the Tom Cruise-movie Minority Report, a futuristic thriller in which a specialized police department called Precrime “apprehends criminals by use of foreknowledge provided by three psychics.”

Denying people pain medication based on a flawed genetic test that falsely claims it can predict the future is basically the same thing. And it’s just as evil in real life as it is in the movie.  

Why Life With Chronic Pain Makes Every New Ache Extra Terrifying

By Crystal Lindell

Late Sunday night, while putting freshly cleaned sheets onto my bed, I twisted a little weird and threw out my back.

By Monday morning, the pain was so debilitating that I was sobbing as my fiancé tried to help me out of our bed. But beyond dealing with the immediate physical pain, I was also terrified of the future.

As a chronic pain patient, every time I get any new illness or affliction I worry that it will become what the rib pain I woke up with in 2013 became: Permanent. 

When you develop chronic health issues of any sort, you lose one of the healthy population’s greatest luxuries: The ability to assume that you’ll eventually get better. 

Thankfully, I seem to be recovering from this flare up of back pain. Three days after the initial onset, I’m able to lift myself out of bed, and even do some light cooking in the kitchen. 

This is the first time I’ve ever experienced any type of severe back pain like this though, and I had been very stressed that my back would never recover.

This isn’t the first time I’ve faced this fear. 

When I had a bad case of COVID in 2022, I spent the first few nights awake with the most severe cold-related muscle aches I’d ever experienced.

In my fever state, I frantically Googled to see if this was a symptom that could become permanent. I was petrified that my body was just broken like this forever. Thankfully it wasn’t, but I know all too well that there’s no guarantee of recovery when it comes to the human body.

It’s not just my health I worry about either. 

Anytime a loved one tells me about a chest cold, some new joint pain, or any type of new health issue, I panic that their body will never recover. Or worse, what if it kills them?

This fear has only been made worse since 2020, when COVID, which first presents as cold symptoms, started spreading. In the years since it has killed multiple people I knew. 

Now anytime anyone I know develops so much as a sore throat, I worry that they’re going to die.

I keep this to myself because there’s nothing to be gained by spreading my worry to them, but I worry nonetheless. I know firsthand how fragile our bodies are, how delicate our health truly is. I am all too aware of the fact that any of us can lose it at any time. 

As I've been enduring the new back pain all week, cursing myself for taking my ability to bend over for granted, I’ve thought a lot about my late-father, who died from COVID in 2022. 

I have vivid memories of him throwing his back multiple times throughout my childhood. Now that it has happened to me, I’ve realized that I didn’t spend nearly enough time asking him how he coped with it, and then seemingly got past it. 

My dad’s back was so bad that he was walking with a cane at age 35, when my younger brother was born in 1989. But the cane was gone within a few years and I don’t remember him needing it again after that. 

Talking with my brother this week, he told me our dad blamed his back pain on driving a truck for a living, a profession he eventually gave up so he could pursue computer programming. So, I assume it was the career change that alleviated his back pain. But now that he’s dead, I’ll never really know for sure how he healed his back, or if he even really did.

My late-grandfather on my mother’s side also spent decades of his life battling seemingly untreatable back pain. He passed away when I was a toddler, but stories about his back pain continued long past his death. 

Now, as an adult, I suspect he was one of the links in the genetic Ehlers-Danlos chain that we now know runs along my mom’s side of the family. We both battled the same condition, but he’ll never know that.

Pain is always bad, but as our bodies age in the same ways our parents, and their parents before them have, it does have one small, silver lining: It can help us connect to our ancestors in new ways, helping us more fully grasp the lives they lived before us. 

After battling this back pain flare up this week, I have a new appreciation for how much pain my dad and my grandfather must have endured due to their back problems, and a more fully developed sense of empathy for their troubles. 

So while I will continue to worry that every new health issue will become permanent, including my new back pain, I can take small comfort in knowing that even if that’s the case, enduring it just makes me part of a long line of my ancestors who’ve endured the same before me. 

Human beings suffer, but when we suffer together, it does tend to alleviate our sorrows ever so slightly. 

VA Tweet Recommends Spinal Cord Stimulators While Spreading Opioid Phobia

By Crystal Lindell

A recent post on X (formerly Twitter) from the U.S. Department of Veterans Affairs inadvertently highlights one of the ways that opioid phobia is actively causing a lot of harm. 

On Dec. 31, 2024 the VA made this post on X: 

“Spinal cord stimulation implantation helps Veterans suffering from chronic pain improve their quality of life without narcotics.”

The post links to a VA News article headlined: "Columbia VA performs first spinal cord stimulation implantation."

About 50,000 stimulators are implanted every year in the U.S., but this was the first time the VA hospital in Columbia, South Carolina had done one. There are two major problems with the VA’s post and the related article: 

1. Spinal cord stimulators are often ineffective and sometimes so dangerous they have to be removed. 

2. Recommending them as a method of treatment that can be done “without narcotics” serves to demonize prescription opioids, which are both relatively safe and effective. The use of the word “narcotics” rather than “opioids” also feels intentional, as narcotics is commonly used by law enforcement. 

Overall, the VA’s post and the related linked article are emblematic of a now pervasive attitude among medical professionals: Any treatment that reduces opioids must be good. And if that treatment is bad, well, it’s still good.  

Before we go further into the research about why spinal cord stimulators (SCSs) are so problematic, it's important to explain what they actually are. 

Stimulators are surgically placed near the spine, with a small battery also placed under the skin, usually near the buttocks or abdomen. Patients with back, hip or leg pain then use a remote control to send mild electric signals into their spinal nerves to block pain signals to the brain. 

A quick tip as someone who has a lot of experience with medical interventions: Anytime a doctor says they want to start messing with your spine, you should be wary. 

‘Potential for Serious Harm’

Don’t take my word for it though. There’s tons of research highlighting the negative effects of SCSs. 

As an Associated Press investigation in 2018 found, spinal cord stimulators account for the third-highest number of medical device injury reports to the FDA, with over 80,000 incidents flagged over the previous decade. The AP also found that the FDA had more than 500 reports of people with stimulators who died.

In 2022, a study published in the Journal of Patient Safety analyzed adverse effects involving SCSs reported to the Australian Therapeutic Goods Administration. That research found 520 adverse events, with most rated as severe (79%) or life-threatening (13%).

“Spinal cords stimulators have the potential for serious harm, and each year in Australia, many are removed. In view of the low certainty evidence of their long-term safety and effectiveness, our results raise questions about their role in providing long-term management of intractable pain,” researchers concluded.

Additionally, a January 2024 article from the American Academy of Family Physicians headlined: "Despite Weak Evidence, Spinal Cord Stimulators Are Big Business” also highlights their shortcomings. 

In it, author Kenny Lin, MD, writes: "These devices come with a high price tag ($30,000) and potential complications that include electrode migration, hematoma formation, infection, spinal cord injury, and cerebrospinal fluid leak."

Lin also notes that in a 2020 letter to health care providers, the FDA reported that over a four year period, it received nearly 108,000 reports involving SCSs, including 428 deaths, nearly 78,000 injuries, and over 29,000 instances of a device malfunction. 

That seems like an unacceptably high rate of unintended effects for a device with modest benefits.

It’s disappointing, but not surprising, to see the VA perpetuate dangerous medical information promoting spinal cord stimulators, especially as some sort of magical alternative to “narcotics.” 

Messaging from government agencies holds power and needs to be used responsibly. I would hate for a veteran to see that post on X, decide to get a spinal cord stimulator, and then end up with adverse effects. I’d also hate for any VA doctors to see that post and conclude that they should be pushing the stimulators over something like hydrocodone. 

The whole situation reinforces how far we have strayed from rational opioid policy, and how far we have to go if we ever want to have one. At this point, I’m not sure I’ll live long enough to see that happen. 

More Lackluster Results for Non-Opioid Pain Reliever

By Pat Anson

New questions are being raised about the effectiveness of an experimental non-opioid analgesic and whether it can be a viable alternative to opioid pain medication.

Results from Vertex Pharmaceuticals’ Phase 2 clinical trial show that suzetrigine is essentially no more effective than a placebo in relieving back and hip pain caused by lumbosacral radiculopathy (LSR).

After 12 weeks of treatment with the drug suzetrigine, patients with LSR had a 2.02 average reduction in their pain scores on a rating scale of zero to 10. That compares to an average reduction of 1.98 for patients who received a placebo or sham treatment.

Although the difference between 2.02 and 1.98 is minuscule, Vertex claimed the overall findings were “statistically significant and clinically meaningful” in a press release. The company blamed the lackluster results on the placebo effect and the difficulty of treating lumbosacral radiculopathy.

“Suzetrigine has again demonstrated its potential to fill an important unmet need in the treatment of pain,” said Carmen Bozic, MD, Executive Vice President and Chief Medical Officer at Vertex. “We did not see separation between the suzetrigine and the placebo arms. Yet our post-hoc analyses suggest that this could be due to the high placebo response in this study.”

Despite the disappointing results, Vertex still plans to go ahead with a Phase 3 study of suzetrigine for LSR, while changing the study design to minimize the impact of the placebo.

“Managing the placebo response in pain trials is a complex challenge. We look forward to innovating in clinical trial design, including for the pivotal study, with the aim of bringing a potentially safe and effective treatment to patients suffering from LSR," said Christine Sang, MD, co-chair of Vertex’s Peripheral Neuropathic Pain steering committee and principal investigator of the study.

Suzetrigine is already under consideration by the FDA as a treatment for acute pain, with a decision expected in late January. If approved, suzetrigine would be the first new medication for acute pain in over two decades.

Unlike opioids, suzetrigine blocks pain signals in the peripheral nervous system before they reach the brain. That means it won’t have the “liking” effect that opioids can have in some patients or be as addictive.

Although suzetrigine has been touted as a novel painkiller that "could bring relief to millions” without the risk of addiction, findings from earlier studies have also been mixed. In a Phase 3 trial of patients recovering from minimally invasive surgery, suzetrigine was no more effective than a low dose combination of hydrocodone and acetaminophen, more commonly known as Vicodin.

Although Vertex downplayed the results from the Phase 2 study, shares of the company lost about 15% of their value after last week’s announcement. Wall Street analysts said the Phase 2 findings were “very messy” and "raise considerable risk around suzetrigine's potential.”

Ultimately, it will be up to the FDA to decide whether suzetrigine should be allowed on the market. The agency is under pressure to approve new non-opioid analgesics, so it may look past the disappointing clinical trial findings. If approval is granted in January, it will coincide with implementation of the NOPAIN Act, which will make non-opioid analgesics in outpatient surgical settings eligible for higher Medicare reimbursement rates.  

In addition to acute pain and lumbosacral radiculopathy, Vertex is also studying suzetrigine as a treatment for diabetic peripheral neuropathy.

You Are a Medical Commodity

By Dr. David Hanscom 

The shocking murder of a health insurance executive and the glorification – by some – of Luigi Mangione, the alleged killer, has underscored how many Americans feel about the U.S. healthcare system.

Medicine has become big business and you, the patient, are a hot commodity. You and your health problems are the main source of revenue for many companies needing to report big profits to their shareholders. In this era of so-called health reform, it’s essential to understand what this means to you – and the news is not good.

As a spine surgeon, I enjoy caring for patients and performing surgeries when needed, and do my best to help people feel better and function well. Unfortunately, most people getting spine surgery today not only won’t be helped, they’ll suffer more as a result of complications from surgeries they shouldn’t have.

For example, let’s look at spinal fusion for low back pain. There is clear research showing that only about 25% of patients significantly benefit from a spine fusion for lower back pain. Another report from Washington State, where I practiced, showed that just 15% of people who had a spinal fusion returned to work one year after their operation.

Physicians today are trained to use evidence-based data to make treatment decisions – and yet, when it comes to low back pain, the data is routinely ignored. A 2009 study showed that physicians eschew established clinical guidelines for best practices in treating back pain.

3 Patient Stories: George, Teresa and Tom

George, a middle-aged businessman, had lower back pain. The first spinal fusion he had didn’t help, so he had another. As a result of complications from that second (unnecessary) surgery, he lost bowel and bladder function, and has to walk with crutches.

Teresa was struck in the back by a swinging steel beam while at work. It was a significant blow, but she only had a bruise, no fractures.  Her discomfort was treated with 15 sets of injections that included facet blocks, epidural cortisone injections, and dye into most of her discs.

She also underwent a spinal fusion from her neck down to her pelvis – an operation that made it impossible for her to stand upright, as she was fused in a flexed-forward position. I was able to help her stand up straight again after a 10-hour procedure that involved cutting her spine in two to re-straighten her back.

Had Teresa only gotten some work on her back muscles after the workplace injury, she could have gone back to everyday life without surgery.

Tom had a narrowing of his lumbar spinal canal caused by spinal stenosis, which caused weakness in his legs. The stenosis should have been treated with a simple, three-level laminectomy (simple removal of bone), as his spine was stable. Instead, he had surgery to fuse his spine at eight levels from his 10th thoracic vertebra to the pelvis. A fusion is only indicated for an unstable spine and is a much bigger operation.

After the fusion, Tom suffered a series of infections and fractures, requiring 15 additional operations in 30 months. He is now solidly fused at 24 levels from the base of his skull to his pelvis. He did not do well.

I could share dozens of stories like these, all with a common theme. Though they were experiencing back and leg pain, not a single one required fusion surgery. Fusions are necessary and helpful only for unstable or deformed spines, and they do not relieve back pain. The more significant number of levels fused during surgery requires more extended operations, which have a higher chance of complications.

All three of the patients I described above could have been helped with a structured spine care program to implement known effective treatments to decrease their pain and improve the odds of a successful surgery.

Instead, they were subjected to unnecessary risks and unspeakable misery. Spread out over the hundreds of thousands of other patients who could tell similar stories, the costs to society in dollars and human suffering are enormous.

Why Is This Happening?  

There are several reasons, some concerning how doctors are trained, but money is a significant factor. Spinal fusion is a lucrative procedure for hospitals.  Hospitals now employ an increasing number of physicians and many use their electronic medical records to track the number of diagnostic tests that their doctors order and the surgical procedures they perform. Doctors are rewarded financially with bonuses for doing as many surgeries as possible, but they get negative ratings for not doing enough to contribute to the institution's profitability.

That’s bad enough, but even worse, these highly profitable procedures have been well-documented as not working. Effective treatments are often (usually) not covered by insurance. Instead of solving and preventing disability, the business of medicine is creating it. The total cost of chronic disease in the U.S. is approaching $4 trillion a year. Yet nothing is being done to solve it.

The Hippocratic Oath swears us doctors to first to do no harm. That also means doing the right thing for our patients, regardless of the situation. It is often said that the financial incentives need to change to create a healthier medical system. The Oath does not say to treat patients with the best standard of care only if they can pay for it.

One place change has to occur is with each physician refusing to be intimidated by hospital administrators and by demanding more time to talk to their patients.

This is a complicated state of affairs, and I am not blaming any group for causing it. I am continually impressed by how committed physicians are to doing the right thing for patients. But in this practice-for-profit climate, they need to be allowed more time or be given the resources to do so.

Only about 10% of spine surgeons implement psychological screening prior to surgery that will optimize a patient’s chances of a successful outcome. Many surgeons don’t feel it is their responsibility. Really? Are we going back to the days when barbers were the surgeons? Are we only technicians?

Hospital systems are problematic because administrative costs have risen 3,000% over the last 10 years, while physician salaries have grown by 15%. The increased “productivity” goes directly into management’s pockets.

BTW, 65% of personal bankruptcies are caused by medical bills. Could this be a factor in creating our homelessness epidemic?

Profits Over Safety

The core problem lies with the healthcare-for-profit model and the scale at which it is being practiced. It is focused on making money off of illness, rather than encouraging wellness. Businesses must operate profitably, but at whose expense? Is there any shareholder willing to trade their health for the betterment of the bottom line? Why should you be the one to be the fuel for this machine?

We can’t afford to continue down this road. Medical consumers – that’s you, me, and our husbands, wives, mothers, fathers, sisters, brothers, sons, and daughters -- are the core revenue source. We must become better, more educated and more vocal consumers of healthcare, and we must refuse to be treated like medical commodities.

This effort needs to begin NOW and with one person at a time. You deserve much better than this.

David Hanscom, MD, is an orthopedic spine 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.

David is the author of ”Back in Control: A Spine Surgeon's Roadmap Out of Chronic Pain,” one of the books on back pain that was read by Luigi Mangione.

What Qualifies Someone as Disabled?

By Crystal Lindell

There’s a common question in the disability community about what qualifies someone as “disabled.”

My advice to anyone considering this question about themselves is this: People who are not disabled do not sit around contemplating whether or not they are disabled. 

So, if you are wondering if your health issues qualify you as disabled: They do.  

A lot of Americans have a rigid idea of “disability” based on how it’s often portrayed in popular culture. The idea is that “real” disabled people use something like a wheelchair, a walking cane, or a walker. Those Hollywood props are what qualifies someone as legitimately disabled. 

But in real life, that’s not true. Disability is often gradual, slowly chipping away at our abilities – but taking them away nonetheless. Which means it can be hard to know when we’ve crossed the threshold into fully disabled. And we may arrive there without so much as a walking cane. 

In truth, it took me years to fully grasp this about my own diminishing health. 

My pain often makes it so that I cannot leave the house, even with pain medication. Grocery shopping trips leave me exhausted, assuming I even have the energy to push through that day’s pain to navigate the store in the first place. I am on daily medications, I put off showers because they are too difficult for me to handle, and I often cancel plans last minute when my body decides to be uncooperative. 

Yet despite all of that, I still did not know if I should consider myself "disabled."

Over time though, I have come to realize that my health problems impact so many aspects of my life, that of course I am disabled. 

After we decide to take on the label of “disabled” for ourselves, we often meet the next hurdle: pushback from loved ones and strangers who bristle at the distinction. 

There’s also a common sentiment among patients with chronic illness where they think if they meet some imaginary threshold of disabled, then finally people will start to accept their limitations and maybe even show some sympathy. Unfortunately, that is often not the case. 

When it comes to health issues, you will never find validation from others. There is no level of mobility aids or level of diagnosis you can get where people who’ve dismissed your health issues in the past will suddenly start to accept them. 

That’s in large part because when people interact with a disabled person, it requires them to contemplate the fact that their own body could eventually fail them one day. 

Some people choose to hold space for that realization in themselves and then express empathy. But others try to reject it, choosing instead to accuse the disabled person of being overdramatic. That’s because they don’t want to consider just how vulnerable our human bodies really are.  

I’ve heard people dismiss diagnosed cancer patients as “hypochondriacs” for complaining about their symptoms. I’ve seen people claim that POTS is not a real disability, despite the fact that it’s often debilitating and life-altering. And I’ve heard people tell loved ones not to use a wheelchair when they need it, because it might make them “give up.” As though we are ever allowed to give up in our bodies. 

Personally, I think of the time I sprained my ankle back in high school. At the time I was working at Walmart, and I went into work despite the severe pain, swelling and bruising on my ankle. Unable to put any weight on it, I used one of the store’s electric mobility scooters to get around the store during my shift. 

A co-worker felt the need to come right up to me and tell me that I shouldn’t be using it because I should be saving the scooters for people who “really” need them. Apparently being unable to walk did not qualify me. 

My advice here is that other’s opinions of your body are irrelevant. They don’t know what it’s like to live with your symptoms, so it doesn’t matter if they accept the label of disabled for you or not. All that matters is that you accept whatever you label you decide to use. 

And, like I said, if you’re wondering if you are “disabled” you probably are. And that’s okay. Now that you’ve named it, you can get on with the noble work of finding new ways to live with it.

Suspect in Shooting of UnitedHealthcare CEO Had Chronic Back Pain

By Pat Anson

The 26-year-old suspect arrested for last week’s brazen shooting of an insurance company executive suffered from chronic back pain severe enough to require surgery.

Luigi Mangione was detained at a McDonald’s in Altoona, Pennsylvania after a witness reported to police that he looked similar to the man wanted in the Manhattan assassination of Brian Thompson, CEO of UnitedHealthcare. Mangione was initially held on gun charges, and later charged with murder by New York City police.  

"He matches the description of the person we are looking for," NYC mayor Eric Adams said in a news conference.

Mangione had a handgun and a silencer that were "consistent with the weapon used in the murder," according to NYPD Commissioner Jessica Tisch.

He also had several fake IDs and a handwritten manifesto that explained his motives. Police sources told the New York Post that Mangione hated the U.S. healthcare system.

“These parasites had it coming,” the manifesto reportedly says. “It had to be done.”

Mangione is a graduate of the University of Pennsylvania, where he majored in computer science and received a master's degree in engineering.

LUIGI MANGIONE / x

In his online accounts, Mangione wrote about artificial intelligence and reposted links about psychedelics and mental health. He also shared that he suffered from spondylolisthesis, a chronic condition where vertebrae in the spine slip out of place and cause back pain.

Mangione’s profile on Twitter/X includes an x-ray image of several screws embedded in a spine. It appears to be his own x-ray. A second image shows a smiling and seemingly fit Mangione hiking bare-shirted in Hawaii.

A friend and former roommate of Mangione said he had to spend several days in bed after aggravating his back during a surfing lesson in Hawaii.

“He was in bed for about a week. We had to get a different bed for him that was more firm,” R.J. Martin told CNN’s Erin Burnett. “And I know it was really traumatic and difficult. You know, when you're in your early 20’s and you can't do some basic things, it can be really, really difficult.”

Martin said Mangione was thoughtful, friendly and communicated well. The two fell out-of-touch when Mangione left Hawaii, but exchanged texts earlier this year.

“I knew he was going to have a surgery. So earlier this year, I checked in with him. He confirmed that he had had surgery, and he sent me the X rays. It looked heinous with just giant screws going into his spine,” Martin said.

“After that, he called me once and I didn't pick up. We kind of texted a little bit, but we lost contact unfortunately. I feel terrible now. I wish I would have made more of an effort to communicate with him.”

‘Violence Is Necessary to Survive’

While in Hawaii, Martin says Mangione started a book club with his roommates. His profile on Goodreads shows a particular interest in back pain. He listed five books about it, including “Back in Control: A Spine Surgeon's Roadmap Out of Chronic Pain” by Dr. David Hanscom and “Crooked: Outwitting the Back Pain Industry and Getting on the Road to Recovery” by Cathryn Jakobson Ramin.

Ramin wrote about the excessive use of epidural steroid injections, calling them the “bread and butter” treatment of interventional pain doctors.

Hanscom wrote his book to explain why he abandoned his 30-year career as a spine surgeon. He was seeing too many patients being harmed by interventional procedures.

“Modern medicine is ignoring this. We are not only failing to treat chronic pain, but creating it,” Hanscom wrote in a PNN column. “Spine surgeons are throwing random treatments at symptoms without taking the time to know a patient’s whole story.” 

On Goodreads, Mangione reviewed the manifesto of “Unabomber” Theodore Kaczynski, the reclusive hermit who planted bombs that killed three people before being caught in 1996. His words suggest that Mangione saw Kaczynski as a counterculture hero who rebelled against an unjust society.

“He was a violent individual - rightfully imprisoned - who maimed innocent people,” Mangione wrote. “While these actions tend to be characterized as those of a crazy luddite, however, they are more accurately seen as those of an extreme political revolutionary.

'When all other forms of communication fail, violence is necessary to survive. You may not like his methods, but to see things from his perspective, it’s not terrorism, it’s war and revolution.'

It’s not known if Mangione’s back pain became worse after his surgery or what role, if any, United Healthcare had in his treatment.

His friend Martin was shocked by Mangione’s arrest and alleged involvement in murder.

“I can make zero sense of it. You know, there's never justification for violence. We live in a democratic system with processes and procedures to address our issues. I can make no sense of it,” he said.

If Mangione did resort to violence against the healthcare system, he wouldn’t be the first patient to do so. In recent years, doctors in Indiana, Nevada and Oklahoma have been shot by disgruntled pain patients or their spouses.  

7 Practical Gift Ideas for People with Chronic Pain

By Crystal Lindell

Whether you’re looking for gift ideas for a loved one with chronic pain, or you’re looking for some ideas for your own wish list, we’ve got you covered. 

I’ve been living with chronic pain for more than 10 years now, and below is a list of some of my favorite things that would also make great gifts for the person in pain in your life. 

And don’t worry, it’s not a bunch of medicinal stuff. Being in pain doesn’t represent our entire identities. The list below is a lot of fun items that would be great for anyone on your list, but that also are especially great for people with chronic pain.

There’s also stuff for every price range, so you’re sure to find the perfect holiday gift! 

Note that Pain News Network may receive a small commission from the links provided below. 

1. Heated Blankets

I put heated blankets first on this list for a reason – they are truly invaluable if you have chronic pain. Even if you live in a warm climate, they can be great to use if people you live with want the AC on the high side. 

There’s just something that’s both cozy and comforting about curling up with a blanket that literally warms you up. I can’t recommend them enough, both as a gift and for yourself. 

I personally loved this Tefici Electric Heated Blanket Throw so much that after getting one for my house, I literally ordered 4 more so I could give them out as Christmas gifts to my family. They all loved them too. And so did their pet cats! 

Find it on Amazon here: Tefici Electric Heated Blanket Throw

The Tefici was actually my intro to heated blankets. After purchasing one for my living room, I was hooked. So I leveled up to this Shavel Micro Flannel Heated Blanket. 

It was a little more expensive than the heated throw, but I got it in 2021, and it’s still going strong. We use it in the bedroom every single night during our cold Midwest winters, and I can’t imagine sleeping without it. It offers more heat settings than the throw, and it can stay on for up to 9 hours. The heating mechanism is also more steady than the throw, so it doesn’t feel like it gets too hot overnight. 

Find it on Amazon here: Shavel Micro Flannel Heated Blanket

2. Home Coffee Machine

One thing about chronic pain – or really any sort of chronic illness – is that it makes it difficult to leave the house some days. But that doesn’t mean you have to give up your Starbucks-style coffee. 

With a home espresso machine, and a milk frother it’s really easy to create very similar drinks at home – and they’re much cheaper than Starbucks. 

I’ve personally been a fan of Nespresso machines for years now and I recently got my sister into them as well. Assuming the person you’re buying for likes coffee, and that they don’t already have a Nespresso, getting them one or a related accessory like a frother as a gift can be a really fun idea. 

Plus, then they’ll lovingly think of you every morning when they use it! 

Find it on Amazon: Nespresso Vertuo Pop+ Coffee and Espresso Maker by Breville with Milk Frother, Coconut White

3. Sound Machine

A lot of people with chronic pain have trouble sleeping, but both me and my partner have realized that having some white noise in the background can really help our brains relax overnight. 

There are a lot of options out there, but a basic one at a lower price point is all you really need. I got him the EasyHome Sleep Sound Machine last year for Christmas and we both love it! It now has a permanent place on our bedroom dresser. 

It has 30 Soothing Sounds, 12 Adjustable Night Lights, and 32 Levels of Volume. We use it all winter when it’s too cold to sleep with the fan on for background noise. 

Find it on Amazon: EasyHome Sleep Sound Machine

4. Pajama Pants

As someone with chronic pain, I honestly spend more days in pajama pants than I do in regular pants. And not only do I love wearing them, I also love receiving them as a gift – especially novelty ones. 

My partner is a huge fan of Lord of the Rings, so I got him these Lord of The Rings Men's PJ’s last year for his birthday, and he wears them at least once a week. 

And quick note: If you’re purchasing pajamas as a gift, I always recommend sizing up to make sure they’re super comfortable. 

Find it on Amazon: Lord of The Rings Men's Sleepwear

5. Streaming Devices

There are a lot of streaming devices you can use to connect your TV to the internet, but we’ve had Rokus in our house for years now, so I can personally recommend them. 

We specifically love that they offer this really great search feature, where if you search on the Roku homepage for a movie or TV show title, it will tell you which one of your streaming services offer it, and even which ones have it for free! So no more scrolling in an out of each streaming app trying to find the movie you want to watch. 

As an added bonus, you can also use a feature in the Roku App as a remote if you lose yours, which can come up a lot for people who might be dealing with chronic pain-related brain fog. 

Find it on Amazon: Roku Express 4K+

6. Art Supplies

Having chronic pain means I’m always on the lookout for low-key activities I can do at home, so over the years I’ve gotten really into artistic pursuits. But if you’ve ever tried to start a new hobby, you know that getting all the supplies can be half the battle. 

But that also means that art supplies can make a great gift for someone with chronic pain. Plus, they come at a very wide range of price points, so you can find something perfect without having to overspend. 

I personally have the ai-natebok 36 Colored Fineliner Pens linked below, and I love using them for a wide variety of projects. But there’s also sketch pads, watercolor sets and blank canvas, not to mention color books. 

Find it on Amazon: ai-natebok 36 Colored Fineliner Pens

7. Gift Cards

Of course, when all else fails, sometimes the best gift is a gift card, especially if you’re looking for something last-minute since they can usually be sent via e-mail. 

I especially recommend Amazon gift cards, specifically because they can be used to pay for Amazon Prime Service, which offers both streaming services and fast home delivery – two things that people with chronic pain often love. 

Find it on Amazon: Amazon gift cards

Unnecessary Back Surgeries Performed Every 8 Minutes at U.S. Hospitals

By Pat Anson

Over 200,000 unnecessary or “low value” back surgeries have been performed on older patients at U.S. hospitals over the last three years, about one procedure every eight minutes, according to a new report.

The analysis by the Lown Institute estimates the potential cost to Medicare at $2 billion for unnecessary spinal fusions, laminectomies and vertebroplasties. The procedures either fuse vertebrae together, remove part of a vertebra (laminectomy), or inject bone-like cement into fractured vertebrae (vertebroplasty) to stabilize them.

Lown maintains that fusions and laminectomies have little or no benefit for low-back pain caused by aging, while patients with spinal fractures caused by osteoporosis receive little benefit from vertebroplasties.

“We trust that our doctors make decisions based on the best available evidence, but that’s not always the case,” said Vikas Saini, MD, president of the Lown Institute, an independent think tank that analyzed Medicare and Medicare Advantage claims from 2019 to 2022.  

“In spinal surgery, as with other fields of medicine, physicians routinely overlook evidence to make exceptions, sometimes at shockingly high rates. This type of waste in Medicare is costly, both in terms of spending, and in risk to patients.”

Up to 30 million Americans receive medical care for spine problems each year. While surgery is appropriate for some, the Lown Institute considers many common surgeries overused and of low value to patients. Potential risks include infection, blood clots, stroke, heart and lung problems, paralysis and even death.

Spinal fusions and laminectomies are considered useful for patients who have low back pain caused by trauma, herniated discs, discitis, spondylosis, myelopathy, radiculopathy and scoliosis. Fusions are also appropriate for patients with spinal stenosis from neural claudication and spondylolisthesis; and laminectomies are appropriate for patients with stenosis who have neural claudication.

Wide Variation in Overuse Rates

Nationwide, about 14% of spinal fusions/laminectomies met the criteria for overuse, while 11% of surgery patients with osteoporosis received an unnecessary vertebroplasty.  

The Lown Institute found a wide variation in overuse rates at some of the nation’s largest and most prestigious hospitals. UC San Diego, for example, had a 1.2% overuse rate for fusions and laminectomies; while the Hospital of the University of Pennsylvania had a 32.6% overuse rate.

The largest overuse rate was at Mt. Nittany Medical Center in Pennsylvania, where nearly two-thirds (62.8%) of the fusions and laminectomies were considered inappropriate or of low value.

The Lown report found that over 3,400 doctors performed a high number of low-value back surgeries. Those physicians received a total of $64 million from device and drug companies for consulting, speaking fees, meals and travel, according to Open Payments. Three companies — Nuvasive, Medtronic and Stryker — paid over $22 million to doctors who performed the unnecessary surgeries.

Previous reports by the Lown Institute have also questioned the value of procedures such as knee arthroscopies, a type of “keyhole” surgery in which a small incision is made in the knee to repair ligaments. Research has found that arthroscopic surgeries provide only temporary relief from knee pain and do not improve function long-term.

The American Hospital Association takes a dim view of Lown studies, calling the data cherry-picked and misleading.

Muscle Relaxants Ineffective for Low Back Pain and Fibromyalgia

By Pat Anson

Muscle relaxants are increasingly prescribed “off label” as an alternative to opioid medication, but according to a new analysis they are no more effective than a placebo in treating fibromyalgia and low back pain. They may be beneficial, however, for patients suffering from muscle cramps, neck pain and trigeminal neuralgia.

Researchers reviewed 44 studies involving nearly 2,500 patients who were prescribed a muscle relaxant for various pain conditions. Nine skeletal muscle relaxants (SMRs) were assessed, drugs that were initially developed and then approved by the FDA as anti-spasticity and anti-spasmodic medications:

• Carisoprodol (Soma)

• Baclofen

• Tizanidine

• Cyclobenzaprine

• Eperisone

• Quinine

• Orphenadrine

• Chlormezanone

• Methocarbamol

Despite a lack of evidence on their effectiveness beyond 3 weeks, prescribing of SMRs doubled between 2005 and 2016, with office visits for refills of SMR prescriptions tripling over the same period, indicating they were increasingly being used long-term and off-label. According to a 2021 study, over a third of patients prescribed SMRs did not have a musculoskeletal disorder, a sign of “unnecessary or inappropriate use.”

Researchers involved in the current study, published in JAMA Network Open, reached a similar conclusion that muscle relaxants are overprescribed.

“Despite increasing prevalence and increasing risks of their use, our systematic review suggests only limited evidence of efficacy for long-term use of SMRs for a small subset of pain syndromes,” wrote lead author Benjamin Oldfield, MD, an Assistant Clinical Professor of Internal Medicine at Yale School of Medicine.

“Evidence for effectiveness was strongest for SMRs used for muscle spasms, painful cramps, and neck pain; in studies of SMRs for fibromyalgia, low back pain, headaches, and other syndromes, some showed small benefits and some did not, and on balance studies did not suggest a benefit.”

Oldfield and his colleagues say physicians should consider deprescribing SMRs to pain patients who have been using them long-term without apparent benefit.   

Adverse side effects from SMRs include sedation, somnolence, dizziness and dry mouth. The FDA also warns against taking the drugs with opioids, which could raise the risk of respiratory depression and overdose.

SMRs also increase the risk of falls, fractures, and vehicle crashes. Because of those risks, muscle relaxants should be avoided altogether in elderly patients, according to the American Geriatrics Society.

Why Autumn Weather Is Often Miserable for Pain Patients

Intellectually, I love the concept of a crisp autumn day. I love the idea of pumpkin spice lattes, crockpot chili, and cozy scarfs. But in practice, the intense temperature swings are pretty horrible for me every year.

The cool fall weather here in Northern Illinois is always devastating on my body. Indeed, my chronic pain has been 10/10 the last few days as the temperatures start their yearly drop, and it rains non-stop. 

It’s the same with spring too. Regardless of how much I’m longing for warmer weather every March, the shift from winter to summer means I spend most of the spring in too much pain to function. 

To me, it is obvious that these weather changes impact my pain. I’ve been dealing with it for more than a decade now. And every year, spring and autumn are especially bad. 

Surprisingly, the medical community still questions whether or not the link between weather and pain is real though – and if it is real, why it might be happening. 

“Research still hasn't confirmed a cause-and-effect link between weather and joint pain, though many people insist they can predict the weather based on such aches,” writes Toni Golen, MD, Editor in Chief of Harvard Women's Health Watch, in a 2022 article in Harvard Health,  

A 2015 study looked at whether daily weather conditions and changes in the weather influenced joint pain in older people with osteoarthritis in six European countries.

While they did find a causal link, they hesitated to call it a direct cause, saying that “the associations between day-to-day weather changes and pain do not confirm causation.”

In other words, researchers did not want to say outright that changes in the weather directly causes pain spikes. 

So I guess you’ll have to hear it from me instead: As a chronic pain patient, I can confirm that the effect is real, and it’s not in your head. Weather definitely causes pain spikes.

What might be causing it though? Golen explains that one theory is that changes in barometric pressure — which often happen as the weather changes — trigger pain in the joints. 

“Less air pressure surrounding the body can allow muscles, tendons, and other tissues around joints to expand,” she explains. “This can place pressure on joints, possibly leading to pain.”

Another theory is that cold, damp days make you more likely to do things that can worsen joint pain or stiffness, such as sitting on the couch too long watching movies. 

“Also, since you're expecting discomfort when the weather shifts, you may notice joint aches more than you would otherwise,” Golen adds. “To ward off weather-related joint pain, keep moving with regular exercise and stretching.”

I have to say, the second theory reads as a bit insulting to me. It sounds like health professionals are trying to find another way to blame patients for their pain. 

Personally, I also know that being sedentary is not the cause of my increased pain when the weather changes. That’s partly because when I wake up with pain in the morning, trying to shower and get out of the house quickly is likely to aggravate it. Also, as someone who works from home, I spend most of my days sitting down with a laptop and that usually doesn’t cause my pain to spike.  

As a chronic patient, I also don’t need a study to confirm my experience. I know weather changes cause a pain spike for me, and over the years I’ve learned to cope with it by accepting it. My life is set up so that most of the time, on bad pain days, I have the ability to rest as needed. 

When I first started having daily chronic pain, I would get very stressed about pain spikes, which would make them worse and harder to get under control. But now I know that keeping myself as calm as possible is the key to riding it out. 

I also know that it’s very likely that the pain will start to subside to more manageable levels after a couple of days at the most. And I know to take advantage of my low-pain days to get as much done as possible. In fact, I’m using one this week to write this column.

To me, the link between weather changes and pain spikes is so obvious, that I can’t even believe any doctors would still question it. If you’re among those struggling as the seasons change though, just know, I believe you. 

FDA Clears New Prescription-Only TENS Device

By Pat Anson

Transcutaneous electrical nerve stimulation – more commonly known as TENS – uses mild electric currents to temporarily relieve pain in sore muscles and tissues. Some TENS units are elaborate wearable devices that cost hundreds of dollars, while others are simple gadgets that can be purchased online or over-the-counter for about $30.

Due to lingering questions about their effectiveness, many health insurers don’t cover TENS devices, while others make patients jump through hoops to get reimbursed for them.

Medical device maker Zynex Medical is hoping to bridge the gap in insurance coverage with a new TENS device called TensWave, which is only available by prescription. The company says the FDA has “cleared” TensWave for marketing, allowing sales to begin immediately.

"The introduction of TensWave aligns perfectly with our commitment to providing comprehensive pain management solutions," Thomas Sandgaard, CEO of Zynex, said in a press release.

"We recognized a gap in the market for a high-quality TENS device that meets the specific criteria for insurance reimbursement, and TensWave is our answer to that demand. It complements our flagship multi-modality device, the NexWave, where Interferential current is the main modality and driver of obtaining prescriptions. This device broadens our product portfolio and enhances our support to patients."

ZYNEX IMAGE

Unlike NexWave, which has three different electrical stimulation modalities, TensWave only uses TENS technology, which Zynex believes will make it easier to get insurance coverage. The company currently has no estimate of TensWave’s cost if a patient has to buy it out-of-pocket.   

In its press release, Zynex said TensWave “has been clinically proven to reduce chronic and acute pain,” which is a bit of an exaggeration, because the device did not go through the FDA’s lengthy review and approval process. However, because TensWave has “substantial equivalence” to other TENS units already on the market, it was cleared for sale without ever undergoing a clinical trial to prove its safety and efficacy. This is a common practice allowed by the FDA when new medical devices are introduced.

The World Health Organization takes a dim view of TENS, saying the evidence of its effectiveness in relieving chronic lower back pain is “very low” due to a limited number of clinical trials. In some trials, TENS worked no better than a placebo.

The UK’s National Health Service (NHS) has a similar view of TENS, saying there is not enough good-quality evidence to recommend its use as a reliable method of pain relief.

“Healthcare professionals have reported that it seems to help some people, although how well it works depends on the individual and the condition being treated,” the NHS states. “TENS is not a cure for pain and often only provides short-term relief while the TENS machine is being used.”

A Neurosurgeon’s Explanation of Why He Quit His Job Goes Viral

By Pat Anson

A former neurosurgeon who quit his job due to stress, anxiety, and a growing awareness that he wasn’t helping patients has become an internet sensation this summer.

“Dr. Goobie” (not his real name) posted a video on YouTube last month, explaining why he abandoned his practice and lucrative career performing surgeries on patients with chronic back problems.

“I had good partners. I had good hospitals that I worked at, but something was not right. I was very unhappy. On the surface, it didn't make sense. I was getting paid very well. It was a very well-respected job. I had good colleagues, had good support, but I was the most unhappy that I've ever been,” says Goobie, while on a hike swatting away mosquitoes with snowcapped mountains in the background.

Goobie’s video has gone viral with over 11 million views and nearly 64,000 comments, most of them expressing support for his decision to leave a high stress job in healthcare. His story is also a cautionary tale for anyone considering spinal surgery.

Goobie doesn’t give many personal details, but says he is 40 years old and lives in Washington state. He went to undergraduate school at the prestigious Massachusetts Institute of Technology (MIT), where he studied the potential for robotic arms and legs. When Goobie saw that wasn’t practical as a career, he enrolled in medical school to study neurosurgery.   

“Your job is to relieve suffering,” one of Goobie’s professors would say, an idealistic view of medicine that he shared and aspired to.

In practice, however, after his residency and nine years of performing surgeries, Goobie became disillusioned. It dawned on him that most of his patients with chronic back problems, like degenerative disc disease and spinal stenosis, weren’t getting better.

“I had learned all these fancy spine surgery techniques to do all this incredible surgery work through tiny cuts. It's called minimally invasive spine surgery,” Goobie explained. “I helped a lot of people out, but there were way more people that I couldn't help.

“There are so many people with back problems; neck pain, back pain, nerve pain down their arms and legs. Surgery might make them better for a little bit, but it didn't address what caused that disc to wear out, or the disc to bulge, or the joint to get loose, or the disc in between the bones to disappear, or the bones rubbing on each other. Surgeries don't address that.”

The Leaky Roof Problem

A colleague likened Goobie’s dilemma to a house with a leaky roof. Rain will ruin drywall and cause extensive water damage. You can replace drywall, take out moldy insulation and clean up the interior of a house, but if you don’t fix the leaky roof, the same problem will keep repeating itself.

“That's what I was doing. And the way I realized that is that I could do a perfect surgery, and some people would get better, some people would stay the same, and some people would get worse,” said Goobie.

“Some people would get better before I could operate on them. Even with gigantic bulging discs, they would get better. If I scheduled the surgery a month out, they would sometimes call me a week before surgery and say, ‘Hey Doc, you know my nerve pain is gone. Do I still need to do surgery?’ And that was very confusing to me.”

Why did some patients get better without surgery? Goobie started asking patients detailed questions about their lives and learned the ones who got better had low-stress, healthy lifestyles. They slept well, exercised regularly, had diets low in fat and salt, didn’t smoke, didn’t drink much, and had strong social networks.    

“DR. GOOBIE”

“And I saw that the people who did that, they would heal so quickly that I couldn't operate on them. I mean, sometimes I could, but if I was booked three or four weeks out, a lot of times people who were doing that, they would heal before I could do the surgery,” Goobie said.

“And the opposite was true. The patients that smoked like a chimney. They sat on the couch and they ate hot dogs all day. They had no friends. They were super stressed out. And they didn't sleep well. Those patients, I could do a really good surgery and I would get them temporarily better, but six months or a year later, the same part of their back would have a recurrent problem. Or a different part, a different joint in their back, would have a similar problem. And I would operate on them, and they might get better for six months, and then the same thing would happen. This is the leaky roof problem.”

The problem with the healthcare system, according to Goobie, is that it’s not designed to fix leaky roofs. It needs sick patients who stay sick.

“I'm not knocking any hospital or group that I worked with. I had the privilege to work with really amazing people in amazing hospitals, amazing institutions. But the way that everything is set up is that the hospital needs to make money. They need to grow economically,” said Goobie.

“The problem there is that if you figure out a way to help patients heal, in a way that doesn't include a pill or a surgery, then the hospital and the doctor are in big trouble. Because if you figure out a way to help people heal and you can't charge them for it, then you've just worked yourself out of a job.”

Hero or Snake Oil Salesman?

Other doctors applauded Goobie’s video, calling him “courageous” and “a hero” for speaking out.

“I really commend his approach to medicine and his goal of putting patient care and his own health first. That is not easy to do,” said Dr. John Y.K. Lee, who specializes in brain surgery.   

But some took offense at Goobie’s video, saying he made “numerous false claims” about the effectiveness of spinal surgery.

“He claims that degenerative spine changes can all heal with rest and nutrition, which is simply wrong,” Dr. Tyler Cole, a spinal neurosurgeon, said in a YouTube video of his own. “We all experience degeneration that can be delayed with good health, nutrition and exercise. But it is not magically reversed. You can’t regrow a disc that’s been worn down, despite what a YouTube snake oil salesman tells you.

“The biggest red flag is that he said his patients didn’t do well. If his patients aren’t doing well, it’s his own fault. Not every patient improves, but if a doctor is discouraged about many of his patients doing poorly, to the point of burning out, the doctor is to blame. It’s not some conspiracy to the point of making people sick.”

Goobie is currently unemployed and uncertain about his future. But he’s lost weight, sleeps better and feels much happier. He spends a lot of time outdoors hiking in the Cascade Mountains with his dog, Doobie.

He’s even launched a YouTube channel – appropriately called “Goobie and Doobie” -- in which he shares dozens of beautiful nature videos that feature bubbling streams, mountain meadows and high-altitude hiking..

“There are an infinite number of ways to go up the mountain and reach the peak. But there is only one peak,” Goobie explains. “We are all trying to get to the same place. It's okay to take different paths. We can all learn from each other.”

Goobie hopes his videos will help people sleep better, relax and refocus. It’s the prescription he learned from patients for his own healing.

“I found that hearing those nature sounds really helped; helped me feel better, helped me process what was going on better, be more present and aware, and release that stress and anxiety’” Goobie says. “That's how I came to where I am now. By letting go of neurosurgery, I am able to be outside and be healthier. My dog is able to live a fuller life, and I figured out a way that I can help relieve people's suffering.”

Just like his professor told him.

The Link Between Collagen Deficiency and Arachnoiditis

By Dr. Forest Tennant

A major finding in our studies of adhesive arachnoiditis (AA) is that most AA patients also have hypermobile Ehlers-Danlos syndrome (hEDS) or a related disorder now called hypermobile spectrum disorder (HSD).

AA is a chronic inflammatory condition that causes nerves in the spinal canal to form adhesions that “glue” them together, while hEDS and HSD cause deficiencies in collagen and the immune system.

How are these conditions connected?

Normal collagen is in thick strands that hold connective tissues together and helps resist infections, tearing, and autoimmune degeneration. When collagen is deficient, the strands may be thin, broken, shortened or non-existent. This allows viruses and bacteria to invade, infiltrating tissues and causing more infections than in individuals with healthy immune systems.

Spinal tissue normally contains considerable amounts of collagen, but in patients with hEDS or HSD they are weak and susceptible to deterioration, inflammation, adhesions and scarring. These spinal tissues include intervertebral discs, vertebrae, spinal canal cover (dura and arachnoid layers), ligaments, and cauda equina nerves.

Weaknesses in spinal tissue make persons with hEDS and HSD more susceptible to AA. It’s also not uncommon for them to develop one or more of these conditions before AA:   

• Tavlov cyst

• Spinal fluid leaks

• Chiari

• Tethered spinal cord

• Herniated disc

• Back pain

• Neck pain

• Spinal arthritis

We have found that persons with hEDS and HSD are also susceptible to Lyme disease, cytomegalovirus, herpes 6 virus, and especially the Epstein-Barr virus (EBV). Almost everyone has EBV, which is typically dormant, but the virus may reactivate from its parasitic life in throat membranes or lymphocytes to infiltrate the brain and spinal tissues.

Persons with hEDS or HSD who have back or neck pain for over 90 days should be screened with the new EBV 4 panel test and take measures to hopefully prevent AA. We highly recommended that they take collagen supplements.

In our studies of patients with MRI-documented AA, essentially 100% have EBV autoimmunity and about 70% show EBV reactivation. About half of those that we review do not know they have hEDS or HSD.

For more details on the link between AA, hEDS and HSD, our new book "The Ehlers-Danlos / Arachnoiditis Connection" is recommended.

Forest Tennant, MD, DrPH, is retired from clinical practice but continues his research on the treatment of intractable pain and arachnoiditis.

Readers interested in learning more about this research should visit the Tennant Foundation’s website, Arachnoiditis Hope. You can also subscribe to its bulletins here.  

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

FDA Approves Stem Cell Study for Degenerative Disc Disease

By Pat Anson

The Food and Drug Administration has given the go-ahead for a late-stage clinical trial of an injectable stem cell product that could give new hope to millions of patients suffering from lower back pain caused by degenerative disc disease (DDD).  Up to 400 patients with mild to moderate DDD are expected to enroll in the Phase 3 study later this year.

The trial is being conducted by DiscGenics, a Utah-based biopharmaceutical company that is developing new cell-based therapies for musculoskeletal conditions. It’s one of the first late-stage studies of a stem cell product to win approval from the FDA, which has been openly skeptical of cell-based therapies due to lack of evidence proving their safety and efficacy in clinical trials.

The only stem cell therapies currently approved by the FDA are used to treat sickle cell disease and some cancers. Approval of a stem cell product to treat degenerative discs would be a big step forward for regenerative medicine, and give patients an alternative to fusions and other more invasive spinal procedures.

“The FDA has been very familiar with our process, our product, and the chemistry, manufacturing and controls for quite some time,” says Flagg Flanagan, CEO and Chairman of DiscGenics. “We feel really good about where we are in terms of the patient reported outcomes. But most importantly about the safety. We feel like this cell is extremely safe to be used on human patients and we're feeling really, really good that we can help a lot of people.”

Discgenics’ injectable disc cell therapy (IDCT) is a single-injection biologic treatment designed to halt the progression of lumbar DDD by regenerating the disc “from the inside out.” The active ingredients in IDCT are enriched stem cells known as discogenic cells, which are derived from donated adult human disc tissue.

IDCT has been granted regenerative medicine advanced therapy and Fast Track designations by the FDA. Approval of the Phase 3 study came just weeks after Discgenics released positive results from a combined Phase 1/Phase 2 human trial of IDCT, published in the International Journal of Spine Surgery.

In that study, 60 patients with mild to moderate DDD were randomly assigned to receive an injection of either low-dose discogenic cells, high-dose cells, or a placebo. After one year, patients in the high-dose group had an average reduction in pain intensity of nearly 63 percent, along with significant improvements in their disability and quality of life. The regeneration of discs, which was monitored through MRIs and other imaging tests, was sustained two years after the injection.

“Things even came out a little better than we even expected,” Flanagan told PNN. “We showed very good durability, out to two years with the high dose patients. Anecdotally, we continue to follow some of those high dose patients and we have data in a pretty good cohort out to three years. We have a couple (patients) out to four years and the durability still seems to hold pretty well.”

The Phase 3 trial will consist of two parallel studies of IDCT that will also be randomized and placebo-controlled. Like the two earlier trials, each study will last for two years to assess the long-term safety and efficacy of IDCT. The first participants are expected to be enrolled in the final quarter of 2024.

“We'll start looking for patients and reviewing patient profiles that want to apply for the study shortly,” Flanagan said. “I think this is something where we can help many, many patients hopefully avoid a surgical intervention with an injection in a treatment room.”

People interested in getting updates on the Phase 3 IDCT trial or volunteering for it can submit their contact information to DiscGenics here.

Mesoblast, an Australian company specializing in regenerative medicine, recently began enrolling U.S. patients with chronic low back pain in a Phase 3 study of its proprietary mesenchymal stem cells, which are derived from young and healthy adult donors.