My Use of Opioids Is None of Your Business

By Neen Monty

It seems like everyone these days has an unsolicited opinion about my pain management. Physical therapists, pharmacists, even my dentist has decided they need to weigh in on my opioid use.

Why do health care professionals who do not specialise in pain management feel entitled to comment on the way I manage my severe, long-standing pain? They clearly know nothing about opioids, have not read the studies, and are getting their knowledge from media headlines. If they actually read the studies, they wouldn’t be expressing these ignorant opinions.

But even so, it’s none of their business. If they are not treating my pain, why do they feel entitled to lecture me on a treatment plan that is well outside their expertise?

My rheumatologist doesn’t comment on my gastroenterologist’s treatment plan. My neurologist has zero interest in the way my immunologist is managing my symptoms. So why do health care professionals feel the need to comment on my use of opioids for pain relief?

For years, my pain was well controlled under the guidance of my GP — whom, I might add, is more than capable of managing pain. I never needed a pain specialist. I never needed to jump through ridiculous hoops or prove that my pain was “real enough” to deserve relief. And yet, thanks to the manufactured opioid crisis here in Australia, I was forced into a system that treats pain patients like criminals.

Let’s be clear: I am not an addict. I am a person with severe, incurable and excruciatingly painful diseases. Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) is a progressive neurological disease that attacks my nerves. Refractory rheumatoid arthritis means my immune system is at war with my joints – all of them - and it’s winning.

These are not minor aches and pains. This is not pain that comes and goes. This is constant, severe pain. Pain when I’m at rest and even more pain when I move.  

These are not conditions that can be fixed with a little physio, deep breathing, or positive thinking. They are devastating, life-altering diseases, and pain relief is essential to my ability to function.

And yet, here we are. Every healthcare professional I encounter suddenly thinks my pain medication is their business.

My dentist, who is supposed to focus on my teeth, thinks it’s appropriate to lecture me on opioids.

My physiotherapist, whose job is to help me maintain muscle strength and mass, feels the need to moralise about my use of opioids. He is an expert in physiology and movement science, but knows nothing about pharmacology. Yet he believes that he does. And he's happy to tell me so.

Pharmacists, who definitely should know better, jump on the bandwagon with their judgmental takes. Yes, I have a supply of naloxone, even though it’s the biggest waste of money the government has ever been conned into spending by addiction researchers. I am at zero risk of needing it.

And no, I do not want information about how to taper my pain medicine. I actually need my pain medicine. I take it because I live with neuropathic and nociceptive chronic pain. You should try it sometime. I don’t think you’d enjoy it, but you’d be a better clinician. And person.

All of this unsolicited advice amounts to little more than bullying. Just the mention of an opioid turns some health care professionals into the high school bully. Do you want my lunch money as well?

What is this obsession with controlling other people’s pain relief? Why do you even have an opinion, when it is far outside of your area of practice? How can you possibly think it’s appropriate for you to judge how I treat my disease or my pain, when you met me two minutes ago?

Most of all, where is your empathy? Your compassion? Your human decency?

Lecturing and hectoring me is not compassionate, person-centred care.

Do you have an opinion on whether I take methotrexate or baricitinib for my rheumatoid arthritis? Does it matter, to you, which cDMARD or bDMARD I am taking? You’ve never heard of them, have you? They rarely make media headlines. Yet they are both riskier medications than opioids, and are more likely to cause serious adverse events. Yet you don’t care about those at all.

Do you care about my IVIG infusions? It’s extremely expensive medication. Unlike opioids, which are very cheap.

What about my steroid dose? You should care about that. All health care professionals know that high dose steroids, taken long term, are very dangerous. They often end up killing people. But because ignorant medical practitioners have taken my opioids away, I have been forced to live on high dose steroids. And all the side effects they bring.

But that’s fine with you. You don’t care about my steroid use. Only my poor endocrinologist does. Lovely gentleman. I can tell he truly cares about me as a patient. It shows in the way he treats me. With calm, gentle respect. He also stays in his lane. The only comment he has made about my opioid use is something akin to “I’m sorry you’re in so much pain.”

That’s a good doctor. After my first appointment with him, I went to my car and cried for 15 minutes straight. I’m not used to receiving that kind of compassion and empathy.

I normally get lectures. Unsolicited advice. And scare tactics: “Those drugs will kill you, you know!”

Or disgusted disbelief: “The pain can’t be that bad!”

Or, very commonly, abandonment: “You’re just going to have to learn to live with it.”

But why should I learn to live with pain that is easily treatable? Because you refuse to read the science? Because you like to get your medical knowledge from politicians, corrupt psychiatrists on the take, and researchers who misreport their own data to keep the grant money flowing?

Yeah, I know. At first, I thought all that was a conspiracy theory – no one would be so evil as to harm people who live with horrifically painful diseases just to further their own career, right? Of course not. No one would do… oh wait. Yes, they would.

Opioids are not for everyone. And thankfully, most people will never experience the kind of pain that requires around-the-clock opioids.

But when opioids are the only thing that reduces pain enough so that a person can survive and have a life, then opioids should be given. And in doses that actually relieve the pain, not a dose that some regulator or politician decided would be enough for everyone. Severe pain is a medical emergency. It does not matter if that pain is acute or chronic.

But let’s go back a step. I am in constant, severe pain. My nerves are being destroyed by my immune system, as are my joints. This is a documented and very painful disease process. Yet there is not an ounce of empathy. Not anymore, anyway.

Back in 2011, I went to a GP in absolute distress. I could not cope with the pain anymore and was crawling along the floor to get to the bathroom. The GP was compassionate. He knew that severe RA is a horrifically painful disease. He prescribed oxycodone and I got my life back.

And now? Health care professionals only have one thing to say: “Stop taking those opioids!”

It’s clear that these clinicians do not believe my pain is severe. It’s clear they don’t believe anything warrants long term opioid use. It’s clear that some think I only want opioids to get high.

Most clear of all is that they feel an entitlement to lecture me about it. When they know nothing about my pain.

The stigma created by the manufactured opioid crisis has turned us into the type of patients no doctor wants to treat. We are seen as liabilities. Nuisances. Whiners. Complainers. Time wasters. We’re seen as problems to be managed, rather than human beings in desperate need of help.

“Heartsink patients.” Are you familiar with that term? Google it. Heartsink patients are said to “exasperate, defeat, and overwhelm their doctors.”

I don’t fit that profile. Not even close. Very few people do. The profile was created so that doctors can feel they have the right to save the patient from themselves. Every single healthcare professional seems to think they have the right to weigh in, to judge and to lecture pain patients.

Here’s a radical idea: Mind your own business. Even better, educate yourself.

Read some recent science. Some peer reviewed science. Even read the studies that are referenced in the opioid prescribing guidelines. I promise you, they don’t say what you think they say.

Unless you are my GP or the prescribing doctor actively involved in my pain management, my opioid pain medication is not your concern. Yes, I need to tell you about it, in case you want to prescribe something that interacts with opioids. But that does not give you the right to judge me.

Pain is not a moral failing.

Taking opioids to manage pain is not a character flaw.

And it is none of your business.

Neen Monty is a writer and patient advocate in Australia who is dedicated to challenging misinformation and promoting access to safe, effective pain relief. Drawing on lived experience and scientific research, Neen has created a website for Pain Patient Advocacy Australia that is full of evidence that opioids can be safe and effective, even when taken long term. You can also subscribe to her free newsletter on Substack, “Arthritic Chick on Chronic Pain.”

An ‘All in Your Head’ Diagnosis Can Cause Lasting Harm to Autoimmune Patients

By Melanie Sloan

Feeling disbelieved when knowing that there is something very wrong with your body can have devastating and long-term consequences. One of the most obvious consequences is that you won’t get the correct treatment and support.

A study my colleagues and I conducted of over 3,000 people with autoimmune disease uncovered many extra long-lasting disadvantages when the misdiagnosis involved a mental health or psychosomatic label (often termed an “in your head” misdiagnosis by patients).

These often included feelings of shame, self-doubt and depression. For some, it extended to suicidal thoughts and even suicide attempts.

A further consequence was that people had much lower trust in doctors. This distrust led to some people avoiding seeking further medical help, often for fear of being disbelieved again.

A concerning finding from our study was that these negative emotions and distrust often remained just as strong many years after feeling that a doctor had not believed their symptoms.

Psychological scars were deep and usually unhealed. Over 70% of people reporting a psychosomatic or mental misdiagnosis said that it still upset them. And over 80% said that it had damaged their self-worth.

One of our study participants, who had several autoimmune diseases, told her story that spoke for many: “One doctor told me I was making myself feel pain – I still can’t forget those words. Telling me I’m doing it to myself has made me very anxious and depressed.”

These findings were not just anecdotal. Overall, we found depression levels were significantly higher and well-being levels lower in people who reported receiving mental health or psychosomatic misdiagnoses.

‘It Has Affected My Mental Health’

We chose to use this woman’s testimony in the title of our study: “I still can’t forget those words.” Not only did it accurately reflect our findings, but it symbolises our research team’s ethos to give these often unheard patients a voice.

The hurt of misdiagnosis was compounded by having “nowhere to voice my anger” or distress. Some of the most moving stories were from people whose early symptoms of autoimmune disease, when they were still children, had been disbelieved by doctors.

Even in middle or older age, those words and feelings had remained with them for decades, often felt as strongly as the day that they were heard. As one of the patient partners in our research team described it, they lived the rest of their lives with “seared souls”.

A woman with lupus told the interviewer that her doctor had told her at age 16 that she had “too many symptoms for it not to be hypochondria”. She spoke very emotively and articulately about the damage caused to a developing sense of self.

“It has affected my mental health very negatively and I do think it’s affected me in my like sense of self. It’s not good for anyone at any age but as a teenage girl being told you don’t know your own feelings is absolutely no way to shape a human being.”

It is natural when hearing all these very difficult stories, and seeing the damage caused, to blame doctors, but is that fair? Doctors very rarely set out to cause harm. Rather, in some cases, it is impossible to diagnose autoimmune diseases quickly.

However, our study highlights that some doctors do reach too quickly for a psychosomatic or mental health explanation for autoimmune disease symptoms.

Some research that may have influenced doctors in giving psychosomatic misdiagnoses says that a long list of symptoms is a red flag that the symptoms are not caused by a disease. This generalisation rather dangerously fails to account for the fact that a long list of symptoms is also a red flag for many autoimmune diseases.

Many autoimmune symptoms are also invisible, and there are no clear tests that will show how bad they are to the doctor. Some of the terms that patients find upsetting and dismissive when doctors talk or write about their symptoms include “vague” and “non-specific”.

Doctors often write letters quickly due to health service constraints, sometimes unthinkingly using terms passed down from their seniors; letters that use terms like “patient claims” or “no objective evidence found of” can increase feelings of being disbelieved.

Empathetic Listening

Our research suggests that more doctors need to think about autoimmunity as a diagnosis early on when faced with multiple varied symptoms that often don’t seem to fit together. Above all, many diagnostic clues can be found by listening to and believing the people experiencing the symptoms.

Empathetic listening and support are also required to help misdiagnosed patients heal emotionally – they very rarely can just “move on” as one doctor advised. We should not underestimate the power of doctors saying “I believe you” to patients with multiple invisible symptoms, and “I am sorry for what has happened in the past” if they had a difficult road to diagnosis.

Most of the 50 doctors interviewed for the study reported that misdiagnoses were common in autoimmunity, but few had realised that the repercussions of these misdiagnoses were so severe and long lasting.

Reassuringly, almost all of them were saddened and motivated to improve their patients’ experiences. Several explained that they thought they were being reassuring by telling patients that their symptoms were most likely to be psychological or stress-related and thought this would be preferable to patients worrying about having a disease.

Although many people experience mental health and psychosomatic symptoms, and doctors must consider them as a possible explanation, a clear lesson from our study is that psychosomatic (mis)diagnoses are rarely seen as reassuring to patients with autoimmune disease symptoms. Rather, they are usually deeply damaging with lifelong and life-changing repercussions.

Melanie Sloan, PhD, is a public health researcher at the University of Cambridge. She is also a Senior Research Fellow at the University of East Anglia. 

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

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.

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

Why Knee Pain Tends to Flareup as We Age

By Dr. Angie Brown

Knee injuries are common in athletes, accounting for 41% of all athletic injuries. But knee injuries aren’t limited to competitive athletes. In our everyday lives, an accident or a quick movement in the wrong direction can injure the knee and require medical treatment. A quarter of the adult population worldwide experiences knee pain each year

As a physical therapist and board-certified orthopedic specialist, I help patients of all ages with knee injuries and degenerative conditions.

Your knees have a huge impact on your mobility and overall quality of life, so it’s important to prevent knee problems whenever possible and address pain in these joints with appropriate treatments.

Healthy Knees

The knee joint bones consist of the femur, tibia and patella. As in all healthy joints, smooth cartilage covers the surfaces of the bones, forming the joints and allowing for controlled movement.

Muscles, ligaments and tendons further support the knee joint. The anterior cruciate ligament, commonly known as the ACL, and posterior cruciate ligament, or PCL, provide internal stability to the knee. In addition, two tough pieces of fibrocartilage, called menisci, lie inside the joint, providing further stability and shock absorption.

All these structures work together to enable the knee to move smoothly and painlessly throughout everyday movement, whether bending to pick up the family cat or going for a run.

Causes of Knee Pain

Two major causes of knee pain are acute injury and osteoarthritis.

Ligaments such as the ACL and PCL can be stressed and torn when a shear force occurs between the femur and tibia. ACL injuries often occur when athletes land awkwardly on the knee or quickly pivot on a planted foot. Depending on the severity of the injury, these patients may undergo physical therapy, or they may require surgery for repair or replacement.

PCL injuries are less common. They occur when the tibia experiences a posterior or backward force. This type of injury is common in car accidents when the knee hits the dashboard, or when patients fall forward when walking up stairs.

The menisci can also experience degeneration and tearing from shear and rotary forces, especially during weight-bearing activities. These types of injuries often require rehabilitation through physical therapy or surgery.

Knee pain can also result from injury or overuse of the muscles and tendons surrounding the knee, including the quadriceps, hamstrings and patella tendon.

Both injuries to and overuse of the knee can lead to degenerative changes in the joint surfaces, known as osteoarthritis. Osteoarthritis is a progressive disease that can lead to pain, swelling and stiffness. This disease affects the knees of over 300 million people worldwide, most often those 50 years of age and up. American adults have a 40% chance of developing osteoarthritis that affects their daily lives, with the knee being the most commonly affected joint.

Age is also a factor in knee pain. The structure and function of your joints change as you age. Cartilage starts to break down, your body produces less synovial fluid to lubricate your joints, and muscle strength and flexibility decrease. This can lead to painful, restricted movement in the joint.

Risk Factors for Knee Problems

There are some risk factors for knee osteoarthritis that you cannot control, such as genetics, age, sex and your history of prior injuries.

Fortunately, there are several risk factors you can control that can predispose you to knee pain and osteoarthritis specifically. The first is excessive weight. Based on studies between 2017 and 2020, nearly 42% of all adult Americans are obese. This obesity is a significant risk factor for diabetes and osteoarthritis and can also play a role in other knee injuries.

A lack of physical activity is another risk, with 1 in 5 U.S. adults reporting that they’re inactive outside of work duties. This can result in less muscular support for the knee and more pressure on the joint itself.

An inflammatory diet also adds to the risk of knee pain from osteoarthritis. Research shows that the average American diet, often high in sugar and fat and low in fiber, can lead to changes to the gut microbiome that contribute to osteoarthritis pain and inflammation.

Preventing and Treating Knee Pain

Increasing physical activity is one of the key elements to preventing knee pain. Often physical therapy intervention for patients with knee osteoarthritis focuses on strengthening the knee to decrease pain and support the joint during movement.

The U.S. Department of Health and Human Services recommends that adults spend at least 150 to 300 minutes per week on moderate-intensity, or 75 to 150 minutes per week on vigorous-intensity aerobic physical activity. These guidelines do not change for adults who already have osteoarthritis, although their exercise may require less weight-bearing activities, such as swimming, biking or walking.

The agency also recommends that all adults do some form of resistance training at least two or more days a week. Adults with knee osteoarthritis particularly benefit from quadriceps-strengthening exercises, such as straight leg raises.

Conservative treatment of knee pain includes anti-inflammatory and pain medications and physical therapy.

Medical treatment for knee osteoarthritis may include cortisone injections to decrease inflammation or hyaluronic acid injections, which help lubricate the joint. The relief from these interventions is often temporary, as they do not stop the progression of the disease. But they can delay the need for surgery by one to three years on average, depending on the number of injections.

Physical therapy is generally a longer-lasting treatment option for knee pain. Physical therapy treatment leads to more sustained pain reduction and functional improvements when compared with cortisone injections treatment and some meniscal repairs.

Patients with osteoarthritis often benefit from total knee replacement, a surgery with a high success rate and lasting results.

Surgical interventions for knee pain include the repair, replacement or removal of the ACL, PCL, menisci or cartilage. When more conservative approaches fail, patients with osteoarthritis may benefit from a partial or total knee replacement to allow more pain-free movement. In these procedures, one or both sides of the knee joint are replaced by either plastic or metal components. Afterward, patients attend physical therapy to aid in the return of range of motion.

Although there are risks with any surgery, most patients who undergo knee replacement benefit from decreased pain and increased function, with 90% of all replacements lasting more than 15 years. But not all patients are candidates for such surgeries, as a successful outcome depends on the patient’s overall health and well-being.

New developments for knee osteoarthritis are focused on less invasive therapies. Recently, the U.S. Food and Drug Administration approved a new implant that acts as a shock absorber. This requires a much simpler procedure than a total knee replacement.

Other promising interventions include knee embolization, a procedure in which tiny particles are injected into the arteries near the knee to decrease blood flow to the area and reduce inflammation near the joint. Researchers are also looking into injectable solutions derived from human bodies, such as plasma-rich protein and fat cells, to decrease inflammation and pain from osteoarthritis. Human stem cells and their growth factors also show potential in treating knee osteoarthritis by potentially improving muscle atrophy and repairing cartilage.

Further research is needed on these novel interventions. However, any intervention that holds promise to stop or delay osteoarthritis is certainly encouraging for the millions of people afflicted with this disease.

Angie Brown, DPT, is a Clinical Associate Professor of Physical Therapy at Quinnipiac University. Dr. Brown is a board-certified Orthopaedic Clinical Specialist through the American Board of Physical Therapy Specialties and a Certified Lymphedema Specialist.

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

How Western Diets Can Trigger Rheumatoid Arthritis

By Pat Anson

Researchers are learning more about how some foods and drinks affect our gut bacteria -- and potentially trigger an immune system response that leads to rheumatoid arthritis (RA) and other inflammatory chronic conditions.

The latest example is a review, published in the journal Nutrients, that examines how harmful bacteria can cause a phenomenon known as “gut dysbiosis,” an imbalance of intestinal microorganisms associated with the development of inflammation and autoimmune diseases like RA.

Previous studies have shown that RA patients don’t consume enough dietary fiber, which can cause gut dysbiosis. Fiber helps restore balance by acting as fuel for hungry – and beneficial -- gut bacteria.

“Overall, the current evidence suggests that gut dysbiosis is involved in the pathogenesis of RA,” wrote lead author Andrzej Pawlik, MD, a Professor in the Department of Physiology at Pomeranian Medical University in Poland. “The diversity and richness of the gut microbiome seems to be reduced in RA.

“Diet is an essential dietary factor, but it also acts as environmental trigger. Researchers have reported a dramatic increase in the frequency of autoimmune diseases in developed countries, and some of them suggest that the Western diet could contribute to this phenomenon.”

Western diets typically have more saturated fats and are often low in dietary fiber, which is why RA patients are often told to increase their fiber consumption. One study found that RA patients who ate high-fiber bars and cereals for 28 days showed significant improvement in their physical and mental quality of life. High fiber intake also reduces the risk of obesity, diabetes, hypertension and other cardiovascular diseases.

Vegetarian and Mediterranean diets also promote the growth of healthy bacteria, slowing the progression of RA, and reducing joint pain.

“Dietary factors and interventions have a marked impact in controlling the progression of RA. Lifestyle modifications involving dietary changes such as higher fibre intake and reduced consumption of red meat should be recommended for patients diagnosed with RA,” said Pawlik, who says further studies are needed to examine the influence of probiotics and other diets on the inflammatory process.

Prevotella copri is a gut bacterium that has long been associated with rheumatoid arthritis. There are many others -- and some we’re just learning about.

A 2022 study identified a harmful gut bacteria known as Subdoligranulum didolesgii in about 20% of people diagnosed with RA. The bacterium has not been detected in the intestines of healthy people.

About 1.3 million people in the U.S. and 1 in every 100 people worldwide have RA, a a chronic autoimmune disease in which the body’s own defenses attack joint tissues, causing swelling, inflammation and bone erosion.   

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. 

New Drug Shows Promise in Treating Sjogren's Disease

By Pat Anson, PNN Editor

Sjogren's disease – also known as Sjogren's syndrome – is one of the most frustrating and painful autoimmune conditions. Often accompanied by rheumatoid arthritis, lupus and other immune system disorders, Sjogren's usually begins with dry eyes and a dry mouth, and then slowly progresses to a chronic illness that causes fatigue, muscle and joint pain, and organ damage.

Most frustrating of all is that there are few ways to stop Sjogren's progression and complications that can result in an early death. Eyes drops, anti-inflammatory drugs and pain medication only mask the symptoms temporarily.

“There are currently no disease-modifying therapies for Sjogren's, so current treatment is usually aimed at reducing symptoms," says E. William St. Clair, MD, a Professor in the Division of Rheumatology and Immunology at Duke University School of Medicine.

That could be changing, thanks to a new drug being developed by Amgen and an international research team. In a Phase 2 randomized clinical trial, 183 adult patients with moderate-to-severe Sjogren's received intravenous infusions of dazodalibep (DAZ), a drug that blocks the signals that drive the autoimmune reaction to Sjogren's.

The study findings, published this month in the journal Nature Medicine, show that patients who received DAZ therapy had a significant reduction in disease activity. They also had reduced symptoms of dryness, fatigue and pain.

"This is hopeful news for people with Sjögren's," says Clair, the study’s lead author. "DAZ is the first new drug under development for the treatment of Sjögren's to reduce both systemic disease activity and an unacceptable symptom burden.”

DAZ therapy was generally safe and well tolerated, with mild adverse events such as diarrhea, dizziness, respiratory tract infection, fatigue and hypertension.

Phase 2 studies are only meant to test a drug’s safety and efficacy. Amgen is currently recruiting about 1,000 patients with moderate-to-severe Sjögren's for two larger Phase 3 studies of DAZ therapy. Both are expected to take about two years to complete.  

Dazodalibep is also binge studied as a therapy for rheumatoid arthritis and glomerulosclerosis, a rare kidney disease. The drug was originally developed by Horizon Therapeutics, which Amgen purchased last year for $27.8 billion.

Blood Test Predicts Knee Osteoarthritis Years Before Symptoms Start

By Pat Anson, PNN Editor

An experimental blood test could give doctors and patients a leg up in diagnosing and treating knee osteoarthritis, years before joint damage occurs and becomes visible on X-rays.

"Currently, you've got to have an abnormal X-ray to show clear evidence of knee osteoarthritis, and by the time it shows up on X-ray, your disease has been progressing for some time," says senior author Virginia Byers Kraus, MD, a professor of Medicine, Pathology, and Orthopedic Surgery at Duke University School of Medicine.

Kraus and her colleagues have devised a test that looks for serum biomarkers in the blood that can predict – with a fair amount of accuracy – the development of knee osteoarthritis (OA) up to 8 years before joint damage occurs. Osteoarthritis is the most common form of arthritis, affecting about 10% of men and 18% of women over age 60.

In previous studies, the biomarker test demonstrated 74% accuracy in predicting knee OA progression and 85% accuracy in diagnosing knee OA. The current study further refined the test by narrowing down the number of biomarkers from a dozen to only six.

Using a UK patient database, researchers used the refined test to analyze the blood of 200 middle-aged women with no chronic knee pain; half of whom were later diagnosed with OA and the other half without the disease. The study findings, published in the journal Science Advances, show the test correctly predicted knee OA with 77% accuracy within 6 years.

"What our blood test demonstrates is that it's possible to detect this disease much earlier than our current diagnostics permit," Kraus said in a news release. "This is important because it provides more evidence that there are abnormalities in the joint that can be detected by blood biomarkers well before X-rays can detect OA.

"Early-stage osteoarthritis could provide a 'window of opportunity' in which to arrest the disease process and restore joint health."

There are currently no diagnostic blood tests for OA and there is no cure. Treatment is limited to pain relievers and anti-inflammatory drugs that slow progression of the disease.

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Biologic Drug May Prevent Rheumatoid Arthritis

By Pat Anson, PNN Editor

A biologic drug used to treat rheumatoid arthritis and other autoimmune conditions appears to be effective in preventing the disease from developing, according to the results of a mid-stage clinical trial.

Abatacept is a disease modifying antibody that was approved by the FDA in 2005 to treat moderate to severe rheumatoid arthritis (RA). Sold under the brand name Orencia, the drug interferes with the immune activity of T-cells, which helps reduce the inflammation and joint pain caused by RA. Abatacept is also used to treat psoriatic arthritis and juvenile idiopathic arthritis.

In the phase 2b clinical trial, 213 adult patients in the UK and the Netherlands at high risk of RA were randomly divided into two groups. One group was given weekly injections of abatacept for a year, while the other group received a placebo. Their progress was followed for another 12 months.

The study findings, recently published in The Lancet, show that only 6% of participants in the abatacept group were diagnosed with RA during the treatment period, compared to 29% in the placebo group. After 24 months, 25% of patients in the abatacept group progressed to RA, compared to 37% in the placebo group.

Patients on abatacept also reported lower pain scores, better physical function and quality of life, and had less inflammation in their joints.

“This is the largest rheumatoid arthritis prevention trial to date and the first to show that a therapy licensed for use in treating established rheumatoid arthritis is also effective in preventing the onset of disease in people at risk,” lead author Andrew Cope, PhD, head of King’s College London Center for Rheumatic Diseases, said in a news release.

“These initial results could be good news for people at risk of arthritis, as we show that the drug not only prevents disease onset during the treatment phase but can also ease symptoms such as pain and fatigue.”

One of the patients who participated in the trial was Philip Day, a 35-year-old software engineer and soccer player who had to give up the sport due to joint pain. He was considered at high risk of RA.

“The pain was unpredictable, it would show up in my knees one day, my elbows the next, and then my wrists or even my neck. At the time, my wife and I wanted to have children and I realized my future was pretty bleak if the disease progressed,” Day said.

“Enrolling in the trial was a no-brainer; it was a ray of hope at a dark time. Within a few months I had no more aches or pains and five years on I’d say I’ve been cured. Now, I can play football (soccer) with my three-year-old son and have a normal life.”

There are a few caveats about abatacept. A year’s worth of treatment in the U.S. costs about $37,500, depending on insurance. Most insurers consider abatacept a second or third-line therapy, and won’t pay for it unless other medications are tried first.

Like other biologic drugs that suppress the immune system, abatacept can have adverse side effects such as respiratory tract infections, pneumonia, flu, dizziness, nausea and diarrhea. Abatacept can also interfere with the effectiveness of vaccines.

Those are risks that many RA patients may be willing to accept, given the progressive nature of the disease, which cannot be cured and often results in disability.

“There are currently no drugs available that prevent this potentially crippling disease. Our next steps are to understand people at risk in more detail so that we can be absolutely sure that those at highest risk of developing rheumatoid arthritis receive the drug,” said Cope.

The abatacept study was funded by Bristol Myers Squibb, the maker of Orencia.

‘Game Changing’ Study Finds Cause of Long Covid Brain Fog

By Pat Anson, PNN Editor

Inflamed and leaky blood vessels in the human brain appear to be the cause of brain fog and other cognitive issues in patients with Long Covid, according to a groundbreaking study by a team of Irish researchers.

The discovery that a viral infection may cause cognitive decline could help explain why memory loss, confusion and trouble concentrating is common in patients with other chronic illnesses, such as fibromyalgia, multiple sclerosis and chronic fatigue syndrome (ME/CFS).

Scientists at Trinity College Dublin and FutureNeuro used a specialized MRI to compare the brains of Long Covid patients with brain fog to those without brain fog.

The MRI images show how Long Covid can affect the brain’s delicate network of blood vessels. Patients with brain fog (right column) have significantly more inflammation and blood vessel leakage than those without brain fog (left column).

Patients with brain fog also had more elevated levels of glial fibrillary acidic protein (GFAP) in their blood, which is a sign of cerebrovascular damage often found in patients with repetitive head trauma.

The images and findings are published in the journal Nature Neuroscience.

“For the first time, we have been able to show that leaky blood vessels in the human brain, in tandem with a hyperactive immune system, may be the key drivers of brain fog associated with Long COVID,” said lead author Matthew Campbell, PhD, a Professor in Genetics and Head of Genetics at Trinity College, and Principal Investigator at FutureNeuro. 

“The concept that many other viral infections that lead to post-viral syndromes might drive blood vessel leakage in the brain is potentially game changing and is under active investigation by the team.” 

NATURE NEUROSCIENCE

About 10% of the people infected with the SARS-CoV2 virus develop Long Covid, a broad range of conditions that causes fatigue, shortness of breath, and muscle and joint pain. About half of Long Covid patients also report brain fog or some lingering neurological issue. 

“The findings will now likely change the landscape of how we understand and treat post-viral neurological conditions. It also confirms that the neurological symptoms of Long Covid are measurable with real and demonstrable metabolic and vascular changes in the brain,” said co-author Colin Doherty, Professor of Neurology and Head of the School of Medicine at Trinity, and Principal Investigator at FutureNeuro. 

In recent years, research has found that multiple sclerosis, lupus and other autoimmune conditions are triggered by the Epstein-Barr virus. The exact mechanism is unclear and proving there is a direct link between viral infections and brain fog has been challenging – until now.   

“Our findings have now set the stage for further studies examining the molecular events that lead to post-viral fatigue and brain fog. Without doubt, similar mechanisms are at play across many disparate types of viral infection and we are now tantalisingly close to understanding how and why they cause neurological dysfunction in patients,” said first author Chris Greene, PhD, a research fellow in the School of Genetics and Microbiology at Trinity.

The study was funded by Science Foundation Ireland, the European Research Council and FutureNeuro, a research center for chronic and rare neurological diseases.

New Blood Test Could Save Arthritis Patients Time, Money and Pain

By Arthur Allen, KFF Health News

Erinn Maury knew Remicade wasn’t the right drug for Patti Schulte, a rheumatoid arthritis patient the physician saw at her Millersville, Maryland, practice. Schulte’s swollen, painful joints hadn’t responded to Enbrel or Humira, two drugs in the same class.

But the insurer insisted, so Schulte went on Remicade. It didn’t work either.

What’s more, Schulte suffered a severe allergic reaction to the infusion therapy, requiring a heavy dose of prednisone, a steroid with grave side effects if used at high doses for too long.

After 18 months, her insurer finally approved Maury’s drug of choice, Orencia. By then, Schulte’s vertebrae, weakened by prednisone, had started cracking. She was only 60.

Schulte’s story of pain, drug-hopping, and insurance meddling is all too common among patients with rheumatoid arthritis, who often cycle agonizingly through half a dozen drugs in search of one that provides a measure of relief. It’s also a story of how doctors are steered by pharmacy benefit managers — the middlemen of the drug market — as well as by insurers.

Once people with inflammatory conditions such as rheumatoid arthritis reach a certain stage, the first prescription offered is typically Humira, the best-selling drug in history, and part of a class known as tumor necrosis factor inhibitors, or TNFis, which fail to significantly help about half of the patients who take it.

“We practice rheumatology without any help,” said Vibeke Strand, a rheumatologist and adjunct clinical professor at Stanford. She bemoaned the lack of tools available to choose the right drug while bristling at corporate intervention in the decision. “We are told by the insurer what to prescribe to the patient. After they fail methotrexate, it’s a TNF inhibitor, almost always Humira. And that’s not OK.”

If there’s a shred of hope in this story, it’s that a blood test, PrismRA, may herald an era of improved care for patients with rheumatoid arthritis and other autoimmune conditions. But first, it must be embraced by insurers.

PrismRA employs a predictive model that combines clinical factors, blood tests, and 19 gene patterns to identify the roughly 60% of patients who are very unlikely to respond to a TNFi drug.

Over the past 25 years, drug companies have introduced five new classes of autoimmune drugs. TNFis were the first to market, starting in the late 1990s.

Some 1.3 million Americans have rheumatoid arthritis, a disease in which a person’s immune system attacks their joints, causing crippling pain and, if improperly treated, disfigurement. The newer drugs, mostly so-called biologics, are also used by some of the 25 million or more Americans with other autoimmune diseases, such as lupus, Crohn’s disease, and psoriasis. Typically costing tens of thousands of dollars annually, the drugs are prescribed after a patient fails to respond to older, cheaper drugs like methotrexate.

Insurers Often Determine Treatment

Until recently, rheumatologists have had few ways to predict which of the new drugs would work best on which patients. Often, “it’s a coin flip whether I prescribe drug A or B,” said Jeffrey Curtis, a rheumatology professor at the University of Alabama-Birmingham.

Yet about 90% of the patients who are given one of these advanced drugs start on a TNFi, although there’s often no reason to think a TNFi will work better than another type.

Under these puzzling circumstances, it’s often the insurer rather than the doctor who chooses the patient’s drug. Insurers lean toward TNFis such as adalimumab, commonly sold as brand-name Humira, in part because they get large rebates from manufacturers for using them. Although the size of such payments is a trade secret, AbbVie is said to be offering rebates to insurers of up to 60% of Humira’s price. That has enabled it to control 98.5% of the U.S. adalimumab market, even though it has eight biosimilar competitors.

PrismRA’s developer, Scipher Medicine, has provided more than 26,000 test results, rarely covered by insurance. But on Oct. 15, the Centers for Medicare & Medicaid began reimbursing for the test, and its use is expected to rise. At least two other companies are developing drug-matching tests for rheumatoid arthritis patients.

Although critics say PrismRA is not always useful, it is likely to be the first in a series of diagnostics anticipated over the next decade that could reduce the time that autoimmune disease patients suffer on the wrong drug.

Academics, small biotechs, and large pharmaceutical companies are investing in methods to distinguish the biological pathways involved in these diseases, and the best way to treat each one. This approach, called precision medicine, has existed for years in cancer medicine, in which it’s routine to test the genetics of patients’ tumors to determine the appropriate drug treatment.

“You wouldn’t give Herceptin to a breast cancer patient without knowing whether her tumor was HER2-positive,” said Costantino Pitzalis, a rheumatology professor at the William Harvey Research Institute in London. He was speaking before a well-attended session at an American College of Rheumatology conference in San Diego in November. “Why do we not use biopsies or seek molecular markers in rheumatoid arthritis?”

It’s not only patients and doctors who have a stake in which drugs work best for a given person.

When Remicade failed and Schulte waited for the insurer to approve Orencia, she insisted on keeping her job as an accountant. But as her prednisone-related spinal problems worsened, Schulte was forced to retire, go on Medicaid, and seek disability, something she had always sworn to avoid.

Now taxpayers, rather than the insurer, are covering Schulte’s medical bills, Maury noted.

Precision medicine hasn’t seemed like a priority for large makers of autoimmune drugs, which presumably have some knowledge of which patients are most likely to benefit from their drugs, since they have tested and sold millions of doses over the years. By offering rebate incentives to insurers, companies like AbbVie, which makes Humira, can guarantee theirs are the drugs of choice with insurers.

“If you were AbbVie,” Curtis said, “why would you ever want to publish data showing who’s not going to do well on your drug, if, in the absence of the test, everyone will start with your drug first?”

What Testing Could Do

Medicare and commercial insurers haven’t yet set a price for PrismRA, but it could save insurers thousands of dollars a year for each patient it helps, according to Krishna Patel, Scipher’s associate director of medical affairs.

“If the test cost $750, I still only need it once, and it costs less than a month of whatever drug is not going to work very well for you,” said Curtis, a co-author of some studies of the test. “The economics of a biomarker that’s anything but worthless is pretty favorable because our biologics and targeted drugs are so expensive.”

Patients are enthusiastic about the test because so many have had to take TNFis that didn’t work. Many insurers require patients to try a second TNFi, and sometimes a third.

Jen Weaver, a patient advocate and mother of three, got little benefit from hydroxychloroquine, sulfasalazine, methotrexate, and Orencia, a non-TNFi biologic therapy, before finding some relief in another, Actemra. But she was taken off that drug when her white blood cells plunged, and the next three drugs she tried — all TNFis — caused allergic reactions, culminating with an outbreak of pus-filled sores. Another drug, Otezla, eventually seemed to help heal the sores, and she’s been stable on it since in combination with methotrexate, Weaver said.

“What is needed is to substantially shorten this trial-and-error period for patients,” said Shilpa Venkatachalam, herself a patient and the director of research operations at the Global Healthy Living Foundation. “There’s a lot of anxiety and frustration, weeks in pain wondering whether a drug is going to work for you and what to do if it doesn’t.” A survey by her group found that 91% of patients worried their medications would stop working. And there is evidence that the longer it takes to resolve arthritis symptoms, the less chance they will ever stop.

How insurers will respond to the availability of tests isn’t clear, partly because the arrival of new biosimilar drugs — essentially generic versions — are making TNFis cheaper for insurance plans. While Humira still dominates, AbbVie has increased rebates to insurers, in effect lowering its cost. Lower prices make the PrismRA test less appealing to insurers, since widespread use of the test could cut TNFi prescriptions by up to a third.

However, rheumatologist John Boone in Louisville, Kentucky, found to his surprise that insurers mostly accepted alternative prescriptions for 41 patients whom the test showed unlikely to respond to TNFis as part of a clinical trial. Boone receives consulting fees from Scipher.

Although the test didn’t guarantee good outcomes, he said, the few patients given TNFis despite the test results almost all did poorly on that regimen.

Scientists from AbbVie, which makes several rheumatology drugs in addition to Humira, presented a study at the San Diego conference examining biomarkers that might show which patients would respond to Rinvoq, a new immune-suppressing drug in a class known as the JAK inhibitors. When asked about its use of precision medicine, AbbVie declined to comment.

Over two decades, Humira has been a blockbuster drug for AbbVie. The company sold more than $3.5 billion worth of Humira in the third quarter of 2023, 36% less than a year ago. Sales of Rinvoq, which AbbVie is marketing as a treatment for patients failed by Humira and its class, jumped 60% to $1.1 billion.

Shannan O’Hara-Levi, a 38-year-old in Monroe, New York, has been on scores of drugs and supplements since being diagnosed with juvenile arthritis at age 3. She’s been nauseated, fatigued, and short of breath and has suffered allergic reactions, but she says the worst part of it was finding a drug that worked and then losing access because of insurance. This happened shortly after she gave birth to a daughter in 2022, and then endured intense joint pain.

“If I could take a blood test that tells me not to waste months or years of my life — absolutely,” she said. “If I could have started my current drug last fall and saved many months of not being able to engage with my baby on the floor — absolutely.”

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

Autoimmune Disease Patients Struggle with Diagnosis and Costs

By Andy Miller, KFF Health News

After years of debilitating bouts of fatigue, Beth VanOrden finally thought she had an answer to her problems in 2016 when she was diagnosed with Hashimoto’s disease, an autoimmune disorder.

For her and millions of other Americans, that’s the most common cause of hypothyroidism, a condition in which the thyroid, a butterfly-shaped gland in the neck, doesn’t produce enough of the hormones needed for the body to regulate metabolism.

There’s no cure for Hashimoto’s or hypothyroidism. But VanOrden, who lives in Athens, Texas, started taking levothyroxine, a much-prescribed synthetic thyroid hormone used to treat common symptoms, like fatigue, weight gain, hair loss, and sensitivity to cold.

Most patients do well on levothyroxine and their symptoms resolve. Yet for others, like VanOrden, the drug is not as effective.

For her, that meant floating from doctor to doctor, test to test, and treatment to treatment, spending about $5,000 a year.

“I look and act like a pretty energetic person,” said VanOrden, 38, explaining that her symptoms are not visible. “But there is a hole in my gas tank,” she said. And “stress makes the hole bigger.”

Autoimmune diseases occur when the immune system mistakenly attacks and damages healthy cells and tissues. Other common examples include rheumatoid arthritis, lupus, celiac disease, and inflammatory bowel disease. There are more than 80 such diseases, affecting up to an estimated 50 million Americans, disproportionately women. Overall, the cost of treating autoimmune diseases is estimated at more than $100 billion annually in the U.S.

‘Patients Feel Dismissed’

Despite their frequency, finding help for many autoimmune diseases can prove frustrating and expensive. Getting diagnosed can be a major hurdle because the range of symptoms looks a lot like those of other medical conditions, and there are often no definitive identifying tests, said Sam Lim, clinical director of the Division of Rheumatology at Emory University School of Medicine in Atlanta. In addition, some patients feel they have to fight to be believed, even by a clinician. And after a diagnosis, many autoimmune patients rack up big bills as they explore treatment options.

“They’re often upset. Patients feel dismissed,” Elizabeth McAninch, an endocrinologist and thyroid expert at Stanford University, said of some patients who come to her for help.

Insufficient medical education and lack of investment in new research are two factors that hinder overall understanding of hypothyroidism, according to Antonio Bianco, a University of Chicago endocrinologist and leading expert on the condition.

Some patients become angry when their symptoms don’t respond to standard treatments, either levothyroxine or that drug in combination with another hormone, said Douglas Ross, an endocrinologist at Massachusetts General Hospital in Boston. “We will have to remain open to the possibility that we’re missing something here,” he said.

Jennifer Ryan, 42, said she has spent “thousands of dollars out-of-pocket” looking for answers. Doctors did not recommend thyroid hormone medication for the Huntsville, Alabama, resident — diagnosed with Hashimoto’s after years of fatigue and weight gain — because her levels appeared normal. She recently switched doctors and hopes for the best.

“You don’t walk around hurting all day long and have nothing wrong,” Ryan said.

And health insurers typically deny coverage of novel hypothyroidism treatments, said Brittany Henderson, an endocrinologist and founder of the Charleston Thyroid Center in South Carolina, which sees patients from all 50 states. “Insurance companies want you to use the generics even though many patients don’t do well with these treatments,” she said.

Meanwhile, the extent of Americans’ thyroid problems can be seen in drug sales. Levothyroxine is among the five most prescribed medications in the U.S. every year. Yet research points to some overprescribing of the drug for those with mild hypothyroidism.

A recent study, paid for by AbbVie — maker of Synthroid, a brand-name version of levothyroxine — said a medical and pharmacy claims database showed that the prevalence of hypothyroidism, including milder forms, rose from 9.5% of Americans in 2012 to 11.7% in 2019.

The number of people diagnosed will rise as the population ages, said McAninch. Endocrine disruptors — natural or synthetic chemicals that can affect hormones — could account for some of that increase, she said.

In their search for answers, patients sometimes connect on social media, where they ask questions and describe their thyroid hormone levels, drug regimens, and symptoms. Some online platforms offer information that’s dubious at best, but overall, social media outlets have increased patients’ understanding of hard-to-resolve symptoms, Bianco said.

They also offer one another encouragement.

VanOrden, who has been active on Reddit, has this advice for other patients: “Don’t give up. Continue to advocate for yourself. Somewhere out there is a doctor who will listen to you.” She has started an alternative treatment — desiccated thyroid medication, an option not approved by the FDA — plus a low dose of the addiction drug naltrexone, though the data is limited. She’s feeling better now.

Research of autoimmune thyroid disease gets little funding, so the underlying causes of immune dysfunction are not well studied, Henderson said. The medical establishment hasn’t fully recognized hard-to-treat hypothyroid patients, but increased acknowledgment of them and their symptoms would help fund research, Bianco said.

“I would like a very clear, solid acknowledgment that these patients exist,” he said. “These people are real.”

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

‘Great Potential’ in Stem Cell Therapies for Knee Osteoarthritis

By Pat Anson, PNN Editor

Osteoarthritis of the knee is one of the most common forms of arthritis, causing progressive damage and thinning of cartilage in the knee joint.  Over 32 million American adults have knee osteoarthritis (OA), but most are treated with injections or pain medications that provide only temporary relief and often have side effects.

Could stems cells provide a more effective and long-lasting treatment for knee OA? Clinical trials have had mixed results so far, so a group of researchers in China conducted a meta-analysis of nearly 1,200 studies, weeding out the ones that were poorly designed or biased.

They eventually settled on 16 studies involving 875 patients with knee OA, most of them high quality studies that were randomized with control groups to compare results with.

Their findings, published in the Journal of Orthopaedic Research, show that stem cell treatment was associated with significant reductions in patient-reported pain from the third month onwards.

The most pain relief came from mesenchymal stem cells (MSCs) derived from a patient’s own body fat (adipose tissue) and stem cells derived from umbilical cord blood. Injections of MSCs derived from a patient’s fat provided better pain relief than stem cells from other donors and led to the most recovery of knee joint function.

“Stem cell transplantation proved safe and effective for knee osteoarthritis treatment,” the authors wrote. “Different sources of stem cells have a good effect on alleviating knee joint pain, restoring knee joint function, and minimizing patient trauma.”

The researchers said there was “great potential” for MSC therapy in the treatment of knee OA, but larger studies were needed to confirm their findings.

“The safety and efficacy of MSC therapy require rigorous validation with a larger sample size before clinical application. From the perspectives of relieving knee joint pain, promoting knee joint function recovery, and reducing patient trauma, umbilical cord‐derived stem cells should be considered as a priority option, followed by ADSCs (adipose stem cells), and finally bone marrow‐derived stem cells.”

In 2019, a small Canadian study found that stem cells collected from a patient’s bone marrow significantly reduced knee pain from osteoarthritis for as long as a year. But that study only involved 12 patients.

FDA Foot Dragging

Why are there so few good quality studies? Stem cell promoters have long complained about foot dragging by the Food and Drug Administration, which has been reluctant to approve new stem cell therapies that are not tested in randomized, double-blind, placebo-controlled studies — the so-called “gold standard” in clinical trials.

The FDA sent warning letters to 20 stem cell manufacturers and clinics in 2019, saying they were in violation of FDA guidance requiring stem cells to undergo “minimal manipulation.” The agency said the science behind stem cells made from a patient’s own tissue had not been proven safe and effective.

“There’s a false premise being asserted by some in the field that a product derived from a person’s own body and then manipulated and reinserted for another use different from the one it played in its original location is not subject to FDA regulation,” then FDA commissioner Scott Gottlieb, MD, and FDA Biologics Center Director Peter Marks, MD, said in a joint statement.

Critics say the FDA is still slowing down stem cell research, despite a pledge to approve 10 to 20 cell or gene therapies annually by 2025. So far this year, the agency has only approved five.  

“Despite signs of progress and a strong commitment from FDA leadership to improve its readiness for these cutting-edge therapies, the agency remains far off pace. Its risk-averse approach and culture that’s slow to adapt to new science could become a curse for many patients and the scientific field as a whole, with investment in biotech chilling in recent quarters,” Richard Burr, a policy adviser for health and life sciences consultant DLA Piper, wrote in an op/ed published in STAT News.

Burr is a former U.S. senator and congressman from North Carolina.

“During my time in Congress, I was one of the FDA’s toughest critics, but I also fiercely defended its mission because I believe in it. The FDA now has an opportunity to transform its oversight of cell and gene therapies and deliver on promises made to patients,” Burr said.

CBD Ineffective for Osteoarthritis Knee Pain

By Pat Anson, PNN Editor

Cannabidiol (CBD) is often touted as an effective pain reliever for arthritis. Studies on animals and anecdotal reports from humans suggest that CBD – the non-psychoactive compound in cannabis -- has anti-inflammatory and pain-relieving effects on joint pain.

But in one of the first randomized, placebo-controlled clinical trials of CBD, researchers at Medical University of Vienna found that CBD is not an effective pain medication for knee osteoarthritis, even at high doses.

The study included 86 men and women who suffered from severe pain due to knee osteoarthritis,  a progressive condition caused by the breakdown of joint cartilage.in the knee. About 10 percent of people over age 60 have knee osteoarthritis (OA).

Half the participants received daily doses of CBD in capsules for eight weeks, titrating up to 600mg per day, which is considered a high dose. The other participants were given placebo capsules with no active ingredient. Neither group knew what they were taking.

The study findings, published in The Lancet Regional Health -- Europe, show that CBD did not have a stronger analgesic effect than the placebo. Adverse events were more common in the CBD group, with over half the participants (56%) reporting diarrhea, abdominal pain, fatigue and other mild side effects.

“Our results do not support the yet clinically unproven hopes for CBD as potential supplement or even replacement of potent analgesics, including opioids,” wrote lead author Sibylle Pramhas, MD, Department of Special Anesthesia and Pain Medicine at MedUni Vienna.

"Our study is the first to provide solid information on the lack of analgesic potential of CBD in a common chronic pain condition, due to the comparatively high oral dosage and the long observation period.”

This isn’t the first time CBD came up short in a clinical study. In 2017, Zynebra Pharmaceuticals tested a CBD gel for knee OA with mixed results. The Phase 2 study did not meet its primary goal of reducing the average pain score, although there were some indications the gel improved function and reduced pain severity. The company has since abandoned plans to use the gel for arthritis pain.

A more recent study of a CBD patch for knee osteoarthritis was withdrawn due to “inadequate funding.” Several other clinical studies of CBD for OA pain are underway or recruiting participants, but no results have been posted.

Currently, osteoarthritis knee pain is treated with analgesics such as acetaminophen (paracetamol), diclofenac, ibuprofen or tramadol. For the time being, they may be the best alternatives for pain relief.   

"CBD is not an alternative for pain therapy for osteoarthritis of the knee, so the search for more effective options must continue," says Pramhas.