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.

Low Dose Opioids Do Not Raise Dementia Risk, But High Doses Might

By Crystal Lindell

There’s a new study out showing that low-dose opioids are not linked to an increased risk of developing dementia, but higher doses might. 

Researchers followed the health of over 1.8 million people in Denmark aged 60 to 75, about 5% of whom developed dementia. They tracked the opioid use of those with and without dementia to see what role, if any, opioids may have in causing cognitive decline.

They found that low dose opioids prescribed for chronic non-cancer pain — which they defined as up to 90 total standardized doses (TSDs) — was not consistently associated with dementia risk. However, doses above 90 TSD were associated with a slightly elevated dementia risk before age 90. 

Interestingly, the strongest association between opioids and dementia was found with “weak” opioids such as tramadol.

Total standardized doses are a different way of measuring opioid use than what is typically used in the United States. Medical guidelines in the U.S. focus on morphine milligram equivalents (MME) per day. Depending on the guideline, anything over 50 or 90 MME would be considered a high dose.   

For the Danish study, 1 TSD is the equivalent of 30 MME. So someone with a TSD of 90 is getting the equivalent of 2,700 MME over time. Researchers used this method because they wanted to see what the cumulative effect of opioids would have on dementia.  

“This study found that opioid use of less than 90 TSDs was not significantly associated with increased dementia risk. Above 90 TSDs of opioid use was associated with an elevated dementia risk before age 90 years, which persisted in individuals with chronic noncancer pain and in individuals solely exposed to weak opioids,” researchers reported in JAMA Network Open,.

They also added the favorite caveat of medical researchers everywhere: “Further research should ascertain whether the findings denote causality between opioids and dementia risk.” 

In other words, it is still unclear if taking higher doses of opioids leads to dementia, or if chronic pain puts people at higher risk of dementia. It’s a chicken and egg question without any answers. 

A previous study also found that high doses of opioids slightly raise the risk of dementia, but so did nonsteroidal anti-inflammatory drugs (NSAIDs). So switching someone from opioids to NSAID pain relievers won’t lower their risk.  

Regardless, given the findings in the Danish study about the lower doses, I am glad to see some more definitive evidence that opioids aren’t the cause of every ailment ever. 

I do worry that the study even existing will perpetuate harmful opioid-phobia myths though. For example, the study’s headline – “Opioids and Dementia in the Danish Population” – is just vague enough that casual readers may assume that the research did show a link between opioids and dementia, regardless of the dose. 

It also irks me that researchers included the favorite sentence of opioid-phobia propagandists: "Opioids are frequently used to treat chronic noncancer pain, but evidence of the effect on pain management and quality of life is lacking." 

As usual, the fact that millions of people around the world have told doctors that opioids help their pain is apparently not “evidence.” They can’t trust any of us.  

As someone who’s been on what the researchers would consider “low dose” opioids since I was 29 years old, I can tell you they do help manage my pain and give me a better quality of life. If the researchers found a higher dementia risk for me, I’d still keep taking opioids. 

Opioids are the only thing that allows me to live my life today. I’m not going to give that up because I might have a higher risk of dementia decades from now. In fact, if I did give them up, I suspect there’s a high chance that I would not make it into my senior years anyway, seeing as how opioids are often the only thing that makes my daily pain endurable. 

I suspect I’m not alone. Research like this is unlikely to deter most pain patients from taking opioids, but it could make some doctors hesitant to prescribe them. And that’s a shame. Because a study showing that low-dose opioids aren’t as bad as some feared should make doctors more comfortable prescribing them.

Shingles and My 10-Year-Old Bottle of Vicodin

By Cynthia Toussaint

A few years ago, a friend who’d been through a rowdy case of shingles tried to spook me.

“You of all people, Cynthia, have to get the shingles vaccine. You couldn’t go through this level of pain with all you’ve got going on,” she said.

Yeah, yeah, I thought, normies who don’t live with the flame-broiler called Complex Regional Pain Syndrome can’t hack the small stuff.

While Laura’s warning was well-intentioned, I decided to skip the shot because I’d heard it was a real ass kicker. That, and I’m already an Olympic-level pro at neuropathic pain. I’d be fine without getting the shingles vaccine.      

I bet on the wrong horse.    

In early August, a mysterious pain on the side of my left leg woke me. I’d never had aching pain that hurt so much, and rousted my partner John in alarm. Muscling through my day, the ache turned lava hot while I moaned and yelped. By bedtime, I was writhing and screaming. No position offered a smidge of relief and I ended up pretzelled against the foot board after only a couple hours of sleep.   

I couldn’t make heads or tails of this new pain. It burned something fierce like CRPS, but was unfamiliar. Terrified, I pointed out to John the places on my thigh where piercing pain, like striking arrows, were erupting. Worse, there was a “hatchet” in my groin.

42 years into CRPS, could this be a different kind of pain rearing its ugly head? The new version came complete with a high fever and wipe-out fatigue.

No amount of my old standby’s – rest, heat, distraction, kitty cuddling – offered relief. In fact, the pain kept amping higher, rendering me useless.

Soon, a bright-red, ghoulish rash appeared and began to spread by the hour. It felt like I was starring in my own horror film, with no pause button on the remote.

The next day, it hit me. This is goddamn shingles and I scooted off to an immediate care clinic.

I was disappointed to get a young male doctor and, true to form, he dismissed my symptoms by announcing that I’d burned myself with a heating pad. His only advice was for me to take a picture of the rash for reasons unknown. 

That night, while the rash continued to march on, the redness turned to bubbling blisters, and the next day I found myself back at immediate care.   

This time at the clinic I hit the jackpot, as a skilled and caring female doctor took about three seconds to diagnose shingles. Livid over the previous day’s dismissal, as treatment time was now of the essence, she instructed me to immediately pick up anti-viral medication and start them as soon as I got home.

Before leaving the room, she gave me a major fright. She looked into my eyes and told me that my shingles might become chronic, especially with my long CRPS history. At that moment, I had no doubt I was in for a world of unchartered hurt.                

For the next two months, except for doctor appointments, I lived between my bed and the couch, surviving one minute at a time. The blisters spread from the top of my thigh down to my knee, and up onto my left buttocks. Mixed with exquisite pain were patches of numbness, and my dermatologist gently warned that this might indicate nerve death.        

My allodynia was so severe I couldn’t bear anything touching the rash, and the never-ending pain kept me awake nights. I despised hearing from doctors, again and again, that I had the worst case of shingles they’d ever seen. Their biggest concern was that the rash would spread to my right side, in which case they suspected it would travel to my eyes and I’d likely lose my sight.   

Vicodin to the Rescue

The pain got so bad, John pleaded with me to take a Vicodin from a 10-year-old bottle he’d asked me to keep, just in case. In the past, this was unthinkable as my primary physician warned me that, due to being on a benzodiazepine, combining both medications might suppress my breathing. Despite that, I didn’t hesitate and got my first taste of blessed relief.

Soon my frantic pain doctor directed me to up my dose to four 5mg Vicodin tablets a day. Scared due to being opioid-naïve, I went on three instead. I could survive the pain then, but had zero quality of life. During this miserable time, I gulped laxatives to keep the pipes flowing, and for 10 days hobbled no further than our condo balcony. I was slowly cancelling my life and couldn’t even tolerate a visitor.

I ruminated over worst case scenarios. What if my pain stays chronic at a level ten? Also, my dermatologist told me I might be scarred forever.

Even if my pain improves, could I ever show my disfigured leg in public? Upon seeing the angry rash, my sister-in-law innocently chirped, “You can’t get in the pool with that, Cynthia. It’ll frighten the other swimmers.” I knew she was right and wanted to sob.

Mercifully, in the last month, the pain and rash (four tubes of scar gel and counting!) started to retreat, bit by bit. With great trepidation, I successfully weaned off the Vicodin, but sure enough, I’m left with post-herpetic neuralgia, the chronic pain I so dreaded.

While my numbness and allodynia are improving, the hatchet pain in my groin hasn’t dissipated. I’m over-the-moon happy to be swimming again with no problem, but for the first time this former ballerina is less than limber on her left side, which makes Pilates and Feldenkrais movement therapy formidable challenges.

While there are no guarantees, I remain optimistic for total healing because I take such good care of my body and mind. Three cheers for self-care!

Hands down, shingles at its apex was the worst pain experience of my life, and because of my CRPS, it was far, FAR worse than what a healthy person would have experienced. My doctors and I suspect the immunotherapy I took for cancer care over two years ago played a major role in getting shingles now, as it’s been the root of three prior serious pain complications.                   

While I can’t go back in time and take Laura’s sage advice about getting the almighty shingles vaccine, I can share my cautionary tale in hopes you’ll do so. With a caveat, I shuddered to learn the vaccine – which I’ll be getting in February – isn’t full proof. Inoculated folk can still get shingles, but those cases are rare and usually less severe, which is especially beneficial for those already wrangling with neuropathic pain.          

While I’m slowly moving my shingles nightmare (albeit with PTSD) into the rearview mirror, I’m haunted by a horrific question. Because my pharmacy refused to fill my pain doctor’s new prescription for Vicodin, what would have happened to me if not for my 10-year-old bottle?

In the grips of the worst pain and torture I’ve ever experienced and the absolute hopelessness of relief, in desperation what might I have done?

I don’t know, but am glad as hell I didn’t have to find out. My god, where is the mercy for people with pain?

Cynthia Toussaint is the founder and spokesperson at For Grace, a non-profit dedicated to bettering the lives of women in pain. She has lived with Complex Regional Pain Syndrome (CRPS) and multiple co-morbidities for over four decades, and has been battling cancer since 2020. Cynthia is the author of “Battle for Grace: A Memoir of Pain, Redemption and Impossible Love.” 

Women, Elderly and Rural Americans More Likely to Have Chronic Pain

By Crystal Lindell

American women are more likely than men to experience chronic pain and high-impact pain severe enough to disrupt their lives. Americans of both sexes are also more likely to have pain if they live in rural areas, are over age 65, and of American Indian or Alaska Native descent. 

Those are the findings in a new report from the Centers for Disease Control and Prevention, which found that 24.3% of U.S. adults (60 million people) experienced chronic pain in 2023, while 8.5% (21 million) experienced high-impact pain that limited their daily life and work activities. 

What the report doesn’t tell you is that pain rates have risen dramatically since 2016, the year the CDC introduced its controversial opioid prescribing guideline, which drastically reduced patient access to opioids. Not only has the guideline failed to reduce overdoses, it appears to have worsened pain care for millions of Americans.

In 2016, the National Health Interview Survey estimated that 20.4% (50.0 million) of U.S. adults had chronic pain, while 8% (19.6 million) had high-impact chronic pain. What that essentially means is that 10 million more Americans have chronic pain today than in 2016, and 1.4 million more people have debilitating pain.

The CDC report does not speculate about why pain rates have increased, but a recent study that looked at the same survey data offers some insight, suggesting the increase is due to a number of factors, such as long Covid, more sedentary lifestyles, more anxiety and stress, and reduced access to healthcare.

“The widely-cited 20% prevalence of CP (chronic pain) in the adult US population appears obsolete,” wrote co-authors Anna Zajacova, PhD, and Hanna Grol-Prokopczyk, PhD, in medRxiv. “Our findings indicated that chronic pain, already a widespread issue, has reached new heights in the post-pandemic era, necessitating urgent attention and intervention strategies to address and alleviate this growing health crisis.”

While the CDC report neglects to cover the causes of pain, it does provide a detailed look at chronic pain rates by sex, race, age, and location.  For example, researchers found that people aged 65 and older are three times more likely to have chronic pain than young adults, while Whites are more likely to have pain than Blacks, Hispanics and Asians.

Chronic and High-Impact Pain by Sex:

• Women: 25.4% and 9.6%

• Men: 23.2% and 7.3%

Chronic and High-Impact Pain by Age:

• Ages 18–29: 12.3% and 3.0%

• Ages 30–44: 18.3% and 4.9%

• Ages 45–64: 28.7% and 11.3%

• Ages 65 and older: 36% and 13.5%

Chronic and High-Impact Pain by Race: 

• American Indian and Alaska Native: 30.7% and 12.7%

• White: 28% and 9.5%

• Black: 21.7% and 8.7%

• Hispanic: 17.1% and 6.5%

• Asian: 11.8% and 2.6%

Whether you live in a city, suburb or rural area also affects pain rates, with rural Americans significantly more likely to have chronic pain than those who live in cities. In the CDC study, large metropolitan areas of one million or more people are categorized as “central” or “fringe” counties. Medium and small metropolitan areas are counties with 250,000–999,999 people or less than 250,000 people, respectively. Non-metropolitan areas are rural counties with significantly fewer people.

Chronic Pain by Urban Area:

• Large central metropolitan area: 20.5% 

• Large fringe metropolitan area: 22.5%

• Medium and small metropolitan area: 26.4% 

• Non-metropolitan area: 31.4%

The CDC does not address the impact of chronic pain in its bare-bones report. But independent researchers Anna Zajacova and Hanna Grol-Prokopczyk do in their analysis, pointing out that pain “profoundly impacts” physical, mental and cognitive health, as well as employment, relationships, sexual function and sleep. It all adds up to an economic impact of $560-$635 billion annually — more than any other health condition.

“The findings are a call to action for public health professionals, policymakers, and researchers to further investigate the root causes of this increase. Addressing the rise in chronic pain is critical, as pain serves as a sensitive barometer of population health and has profound economic, social, and health consequences,” they wrote.

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.

ER Opioids ‘Extremely Unlikely’ to Lead to Addiction

By Pat Anson

Many patients in pain have horror stories to share about their experiences in hospital emergency rooms, where they’ve been treated as drug seekers and denied opioid medication.

“I had a broken arm and was given nothing for pain when leaving the emergency room,” one patient told us. “They now treat everyone like a drug seeking addict even if you have legitimate pain!”

“My last ER visit has caused me PTSD. It was awful they put me in a room and turned the light off and left me there for hours,” said another.

“The emergency rooms are horrible,” said a patient with a fractured rib. “I wasn’t even asking the ER for meds. I wanted an x-ray or something because I was in excruciating pain.”

Are fears about opioid addiction justified? A new study found that the risk of developing opioid use disorder after being treated with intravenous opioids in the ER is quite low – less than one-tenth of one percent (0.002%).

Out of 506 patients treated with IV opioids in two Bronx emergency rooms, only one met the criteria for long-term or persistent opioid use six months later.

“These data suggest that the use of IV opioids for acute pain among opioid-naive patients is extremely unlikely to result in persistent opioid use,” wrote lead author Eddie Irizarry, MD, an emergency medicine physician at Montefiore Medical Center.

“Opioid naïve” means the patients had never taken opioids before or only used the drugs infrequently.

The study, recently published in The Journal of Emergency Medicine, defines persistent use as filling six or more opioid prescriptions in the 6 months after an ER visit, or an average of one prescription per month.

The most frequently reported IV opioid administered in the ER was morphine (94%), followed by hydromorphone (4%) or a combination of both morphine and hydromorphone (2%). The researchers noted that most of the morphine doses were “relatively modest.”

After being treated in the ER, 63 of the patients (12%) received an opioid prescription on discharge.   

The researchers cautioned that opioids should be used “judiciously” and that many ER patients could be treated with non-opioid analgesics such as acetaminophen. But they could find no evidence that IV opioids should be routinely denied in the ER.

“We are not aware of compelling data to support denying parenteral opioids to opioid-naïve patients who are suffering from severe acute pain,” said Irizarry.   

The research mirrors the findings from a 2017 Mayo Clinic study, which found that the risk of long-term opioid use is lower for ER patients than it is for patients treated in other medical settings. In the Mayo study, 1.1% of opioid naive patients became long term users. That compares to 2% of patients who were prescribed opioids in non-emergency settings.

FDA’s New Rules Aim to Make Pharma Ads Easier to Understand

By Crystal Lindell

The Food and Drug Administration is hoping that its new rules will make pharmaceutical ads on TV and radio easier to understand. 

Commercials for pharmaceutical drugs must now include a “major statement” about side effects and contraindications in “a clear, conspicuous, and neutral manner.” The rule applies to direct-to-consumer (DTC) ads for prescription drugs and what conditions they are used to treat. 

The new regulations are a response to something many drug makers figured out long ago: people tend to tune out when they start to hear a long list of potential side effects and interactions, which are usually rushed through at the end of drug commercials. By then, consumers may have tuned out the downsides of the medication. 

“If you’re a company and you’re worried about possible FDA enforcement or product liability and other litigation, all your incentives are to say more, not less,” Torrey Cope, a food and drug lawyer, told the AP.

The law firm Lerman Senter broke down the five new standards the FDA requires companies to meet in drug ads. All commercials must now include:

1. Consumer Friendly Language: Ads must clearly state the name of the drug, and a major statement of side effects must be presented in language that is readily understandable. It should not include technical or medical jargon.
   

2. Understandable Audio: Audio information must be understandable in terms of volume, articulation and pacing, and should be as understandable as the rest of the commercial. “Rapid fire” disclosures will no longer be permitted.
   

3. Major Statement Must Be Presented Concurrently in Text and Audio: Television ads must present the major statement simultaneously in the audio and visual sections.
   

4. Text Must Be Easily Readable: The on-screen text must be presented against a contrasting background for sufficient duration, and in a font size and style that is easily readable.
   

5. No Distractions. Advertisements cannot have statements, text, images or sounds that detract from comprehension of the major statement. No other sounds, including music or catchy jingles, should be heard during the side effects disclosure.

While the rule went into effect a few months ago, companies have until November 20 to be in full compliance. So while you may have already noticed pharma ads changing, all of them should be in compliance starting this week. 

In its report about the changes, the FDA said that while drug ads often have a caveat urging people to “ask your doctor” about a medication, pharmaceutical companies are incentivized to make the ads deceptive in various ways. 

“Like all advertisers, prescription drug firms have ample business incentives to present their products in a positive light to potential consumers,” the FDA said. “But those business incentives do not assure clear communication of the advertised drug’s negative attributes to consumers.”

While no federal law has ever banned pharmaceutical companies from directly advertising to consumers, the practice didn't really take off until about 40 years ago. Currently, the United States and New Zealand are the only two countries that allow DTC drug advertising. 

In its report, “Background on Drug Advertising,” the FDA explains: 

"Until the mid-1980s, drug companies gave information about prescription drugs only to doctors and pharmacists. When these professionals thought it appropriate, they gave that information to their patients. However, during the 1980s, some drug companies started to give the general public more direct access to this information through DTC ads."

As someone who was born in the mid 1980s, I remember being surprised as an adult when I learned that most other countries ban pharma companies from advertising directly to consumers. 

While it’s difficult to imagine that the U.S. would ever ban the ads completely, there’s definitely a good case for heavily regulating them. A 2005 study found pharmaceutical ads that encouraged consumers to talk with their doctors “have a profound effect on physician prescribing” and could promote overuse or inappropriate prescribing.

In other words, drug companies are very good at creating ads that make people want to buy their products, whether they need them or not. Let’s be real: if drug advertising didn’t work, companies would not be spending over $15 billion a year promoting their medications. 

I’m glad to see the FDA amping up these regulations, so people have a better understanding of drug ads. But it remains to be seen how these agency regulations will hold up under the incoming Trump administration.   

Will Trump Let RFK Jr. ‘Go Wild’ with Public Health?

By Arthur Allen, KFF Health News

Many scientists at the federal health agencies await the second Donald Trump administration with dread as well as uncertainty over how the president-elect will reconcile starkly different philosophies among the leaders of his team.

Trump announced Thursday he’ll nominate Robert F. Kennedy Jr. to be secretary of the Health and Human Services Department, after saying during his campaign he’d let the anti-vaccine activist “go wild” on medicines, food, and health.

Should Kennedy win Senate confirmation, his critics say a radical anti-establishment medical movement with roots in past centuries would take power, threatening the achievements of a science-based public health order painstakingly built since World War II.

Trump said in a post on the social platform X that “Americans have been crushed by the industrial food complex and drug companies who have engaged in deception, misinformation, and disinformation when it comes to Public Health,” echoing Kennedy’s complaints about the medical establishment. The former Democratic presidential candidate will “end the Chronic Disease epidemic” and “Make American Great and Healthy Again!” Trump wrote.

Vaccine makers’ stocks dipped Thursday afternoon amid news reports ahead of Trump’s RFK announcement.

If Kennedy makes good on his vision for transforming public health, childhood vaccine mandates could wither. New vaccines might never win approval, even as the FDA allows dangerous or inefficient therapies onto the market. Agency websites could trumpet unproven or debunked health ideas. And if Trump’s plan to weaken civil service rights goes through, anyone who questions these decisions could be summarily fired.

“Never has anybody like RFK Jr. gotten anywhere close to the position he may be in to actually shape policy,” said Lewis Grossman, a law professor at American University and the author of “Choose Your Medicine,” a history of U.S. public health.

Kennedy and an adviser Calley Means, a health care entrepreneur, say dramatic changes are needed because of the high levels of chronic disease in the United States. Government agencies have corruptly tolerated or promoted unhealthy diets and dangerous drugs and vaccines, they say.

Means and Kennedy did not respond to requests for comment. Four conservative members of the first Trump health bureaucracy spoke on condition of anonymity. They eagerly welcomed the former president’s return but voiced few opinions about specific policies. Days after last week’s election, RFK Jr. announced that the Trump administration would immediately fire and replace 600 National Institutes of Health officials. He set up a website seeking crowdsourced nominees for federal appointments, with a host of vaccination foes and chiropractors among the early favorites.

At meetings last week at Mar-a-Lago involving Elon Musk, Tucker Carlson, Donald Trump Jr., Kennedy, and Means, according to Politico, some candidates for leading health posts included Jay Bhattacharya, a Stanford University scientist who opposed covid lockdowns; Florida Surgeon General Joseph Ladapo, who opposes mRNA covid vaccines and rejected well-established disease control practices during a measles outbreak; Johns Hopkins University surgeon Marty Makary; and Means’ sister, Stanford-trained surgeon and health guru Casey Means.

All are mavericks of a sort, though their ideas are not uniform. Yet the notion that they could elbow aside a century of science-based health policy is profoundly troubling to many health professionals. They see Kennedy’s presence at the heart of the Trump transition as a triumph of the “medical freedom” movement, which arose in opposition to the Progressive Era idea that experts should guide health care policy and practices.

It could represent a turning away from the expectation that mainstream doctors be respected for their specialized knowledge, said Howard Markel, an emeritus professor of pediatrics and history at the University of Michigan, who began his clinical career treating AIDS patients and ended it after suffering a yearlong bout of long covid.

“We’ve gone back to the idea of ‘every man his own doctor,’” he said, referring to a phrase that gained currency in the 19th century. It was a bad idea then and it’s even worse now, he said.

“What does that do to the morale of scientists?” Markel asked. The public health agencies, largely a post-WWII legacy, are “remarkable institutions, but you can screw up these systems, not just by defunding them but by deflating the true patriots who work in them.”

FDA Commissioner Robert Califf told a conference on Nov. 12 that he worried about mass firings at the FDA. “I’m biased, but I feel like the FDA is sort of at peak performance right now,” he said. At a conference the next day, CDC Director Mandy Cohen reminded listeners of the horrors of vaccine-preventable diseases like measles and polio. “I don’t want to have to see us go backward in order to remind ourselves that vaccines work,” she said.

Stocks of some the biggest vaccine developers fell after news outlets led by Politico reported that the RFK pick was expected. Moderna, the developer of one of the most popular covid-19 vaccines, closed down 5.6%. Pfizer, another covid vaccine manufacturer, fell 2.6%. GSK, the producer of vaccines protecting against respiratory syncytial virus, hepatitis A and B, rotavirus, and influenza, fell just over 2%. French drug company Sanofi, whose website boasts its products vaccinate over 500 million annually, tumbled nearly 3.5%.

Exodus From Health Agencies?

With uncertainty over the direction of their agencies, many older scientists at the NIH, FDA, and Centers for Disease Control and Prevention are considering retirement, said a senior NIH scientist who spoke on the condition of anonymity for fear of losing his job.

“Everybody I talk to sort of takes a deep breath and says, ‘It doesn’t look good,’” the official said.

“I hear of many people getting CVs ready,” said Arthur Caplan, a professor of bioethics at New York University. They include two of his former students who now work at the FDA, Caplan said.

Others, such as Georges Benjamin, executive director of the American Public Health Association, have voiced wait-and-see attitudes. “We worked with the Trump administration last time. There were times things worked reasonably well,” he said, “and times when things were chaotic, particularly during covid.” Any wholesale deregulation efforts in public health would be politically risky for Trump, he said, because when administrations “screw things up, people get sick and die.”

At the FDA, at least, “it’s very hard to make seismic changes,” former FDA chief counsel Dan Troy said.

But the administration could score easy libertarian-tinged wins by, for example, telling its new FDA chief to reverse the agency’s refusal to approve the psychedelic drug MDMA from the company Lykos. Access to psychedelics to treat post-traumatic stress disorder has grabbed the interest of many veterans. Vitamins and supplements, already only lightly regulated, will probably get even more of a free pass from the next Trump FDA.

‘Medical Freedom’ vs ‘Nanny State‘

Trump’s health influencers are not monolithic. Analysts see potential clashes among Kennedy, Musk, and more traditional GOP voices. Casey Means, a “holistic” MD at the center of Kennedy’s “Make America Healthy Again” team, calls for the government to cut ties with industry and remove sugar, processed food, and toxic substances from American diets. Republicans lampooned such policies as exemplifying a “nanny state” when Mike Bloomberg promoted them as mayor of New York City.

Both the libertarian and “medical freedom” wings oppose aspects of regulation, but Silicon Valley biotech supporters of Trump, like Samuel Hammond of the Foundation for American Innovation, have pressed the agency to speed drug and device approvals, while Kennedy’s team says the FDA and other agencies have been “captured” by industry, resulting in dangerous and unnecessary drugs, vaccines, and devices on the market.

Kennedy and Casey Means want to end industry user fees that pay for drug and device rules and support nearly half the FDA’s $7.2 billion budget. It’s unclear whether Congress would make up the shortfall at a time when Trump and Musk have vowed to slash government programs. User fees are set by laws Congress passes every five years, most recently in 2022.

The industry supports the user-fee system, which bolsters FDA staffing and speeds product approvals. Writing new rules “requires an enormous amount of time, effort, energy, and collaboration” by FDA staff, Troy said. Policy changes made through informal “guidance” alone are not binding, he added.

Kennedy and the Means siblings have suggested overhauling agricultural policies so that they incentivize the cultivation of organic vegetables instead of industrial corn and soy, but “I don’t think they’ll be very influential in that area,” Caplan said. “Big Ag is a powerful entrenched industry, and they aren’t interested in changing.”

“There’s a fine line between the libertarian impulse of the ‘medical freedom’ types and advocating a reformation of American bodies, which is definitely ‘nanny state’ territory,” said historian Robert Johnston of the University of Illinois-Chicago.

Specific federal agencies are likely to face major changes. Republicans want to trim the NIH’s 27 research institutes and centers to 15, slashing Anthony Fauci’s legacy by splitting the National Institute of Allergy and Infectious Diseases, which he led for 38 years, into two or three pieces.

Numerous past attempts to slim down the NIH have failed in the face of campaigns by patients, researchers, and doctors. GOP lawmakers have advocated substantial cuts to the CDC budget in recent years, including an end to funding gun violence, climate change, and health equity research. If carried out, Project 2025, a policy blueprint from the conservative Heritage Foundation, would divide the agency into data-collecting and health-promoting arms. The CDC has limited clout in Washington, although former CDC directors and public health officials are defending its value.

“It would be surprising if CDC wasn’t on the radar” for potential change, said Anne Schuchat, a former principal deputy director of the agency, who retired in 2021.

The CDC’s workforce is “very employable” and might start to look for other work if “their area of focus is going to be either cut or changed,” she said.

‘It Won’t Be Harmless’

Kennedy’s attacks on HHS and its agencies as corrupted tools of the drug industry, and his demands that the FDA allow access to scientifically controversial drugs, are closely reminiscent of the 1970s campaign by conservative champions of Laetrile, a dangerous and ineffective apricot-pit derivative touted as a cancer treatment.

Just as Kennedy championed off-patent drugs like ivermectin and hydroxychloroquine to treat covid, Laetrile’s defenders claimed that the FDA and a profit-seeking industry were conspiring to suppress a cheaper alternative.

The public and industry have often been skeptical of health regulatory agencies over the decades, Grossman said. The agencies succeed best when they are called in to fix things — particularly after bad medicine kills or damages children, he said.

The 1902 Biologics Control Act, which created the NIH’s forerunner, was enacted in response to smallpox vaccine contamination that killed at least nine children in Camden, New Jersey. Child poisonings linked to the antifreeze solvent for a sulfa drug prompted the modern FDA’s creation in 1938. The agency, in 1962, acquired the power to demand evidence of safety and efficacy before the marketing of drugs after the thalidomide disaster, in which children of pregnant women taking the anti-nausea drug were born with terribly malformed limbs.

If vaccination rates plummet and measles and whooping cough outbreaks proliferate, babies could die or suffer brain damage.

“It won’t be harmless for the administration to broadly attack public health,” said Alfredo Morabia, a professor of epidemiology at Columbia University and the editor-in-chief of the American Journal of Public Health. “It would be like taking away your house insurance.”

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

The 'Nocebo Effect’ and Irritable Bowel Syndrome

By Dr. Caroline Seiler

Many people find that wheat or gluten cause them to react in some way: Some people have a wheat allergy, some have the autoimmune condition celiac disease, but the majority find they have some sort of intolerance or sensitivity to wheat and gluten.

This is challenging to diagnose because there still aren’t any reliable biomarkers to confirm gluten or wheat sensitivity, and clinicians typically rely on patient self-reports.

In irritable bowel syndrome (IBS), patients experience gastrointestinal symptoms without any visible damage to the digestive tract. Many patients with IBS believe that specific foods, like gluten or wheat, trigger their symptoms, prompting them to exclude these foods from their diets without consulting a dietitian or their doctor.

Unsurprisingly, about a third of IBS patients develop disordered eating habits and perceptions about food that may cause symptoms in and of themselves, such as orthorexia, or an unhealthy preoccupation with healthy eating. This may cause a “nocebo effect,” where patients experience symptoms due to their beliefs and expectations about a substance they assume is causing their issues but is actually inert — a “nocebo.”

As a nutrition researcher at McMaster University’s Farncombe Institute, I’m a member of a team that ran a clinical trial to find out whether wheat, gluten or a gluten-free nocebo caused symptoms in IBS. And the results were surprising: even though some patients experienced worse symptoms from gluten or wheat, they weren’t very different from the nocebo, with similar proportions of patients reacting to each.

These results are similar to other published studies. Identifying the true sensitivities for patients with IBS is a controversial research area, with some studies finding gluten avoidance to be beneficial versus others finding it to have no significant effect.

Researchers from the United Kingdom and the Netherlands published an innovative study from the Lancet medical journal. Patients with reported gluten sensitivity were divided into four groups: Two groups were given gluten-free bread, but one of these groups was told it contained gluten and one was told it didn’t. Two other groups were given bread that did contain gluten, with one group believing it was gluten-free and the other believing it contained gluten.

The results showed that the patients who ate gluten and were also told they were eating gluten had significantly worse symptoms than the other three groups.

Gluten Misinformation

Given the controversial evidence that not only gluten, but other wheat components like fermentable carbohydrates or immune-stimulating proteins, may exacerbate IBS symptoms, it’s possible for this hot topic to get blown out of proportion or taken out of context, contributing to nutrition misinformation.

All of these factors — that it is often diagnosed by excluding all other options, the significant psychological component, the division in the scientific community and clinicians who often discount patients’ experiences — make treatment difficult for patients with this disorder.

As a result, patients with IBS are often left to navigate conflicting online resources and test new diets to treat their symptoms. When researchers challenge patients with gluten, wheat or a nocebo, they rarely report the personalized results back to the patients and see how this information impacts patient behaviour.

At McMaster University, we wanted to see how presenting personalized nutrition information would affect our patients. After providing them with personal results about their gluten and wheat reactions, we followed up with patients after six months or more to see how this impacted their beliefs, behaviours and symptoms.

Again, we were in for a surprise! Patients largely kept similar beliefs about gluten, maintained a gluten-free diet and had consistent symptoms even after learning that most of them did not react to gluten or wheat. This begs the question: when people more generally learn new information that conflicts with an existing belief, what may help them to change accordingly?

Psychological Treatment

IBS has been long understood as a disorder of the gut-brain interaction. Psychological treatments are being increasingly investigated to minimize patient fears of foods, or nocebo effects, and to treat IBS symptoms more generally. At Harvard, a recent study found that exposure-based cognitive behavioural therapy (CBT) showed promise to improve IBS symptoms in five sessions with a nurse practitioner.

Similarly, CBT correlated with shifts in brain networks and the gut microbiome, or gut bacteria, that were also correlated with improvements in gastrointestinal symptoms. At the University of Calgary, virtually delivered yoga was highly feasible and helped improve symptoms for patients with IBS.

However, IBS is a complex disorder which may be exacerbated due to many different causes, and psychological treatment will likely be only one component of an effective treatment plan for many patients.

Diet plays an important role in human health, but how it does so — especially among those with gastrointestinal diseases — becomes complicated by the emotional aspects of eating and the real needs for people to have nutritious, well-balanced diets without risking malnutrition. If you have concerns that certain foods, like gluten, trigger your symptoms, it’s a good idea to consult your doctor or a registered dietitian.

Caroline Seiler, PhD, is a clinical researcher who studied at McMaster University in Ontario, Canada. She receives funding from the Canadian Institutes of Health Research.

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

The Stress of Navigating Opioid Shortages As a Patient

By Crystal Lindell

At 9:30 am Monday morning, I got one of the most dreaded phone calls that someone taking a controlled substance can get – my pharmacy was completely out of my pain medication, Morphine Sul ER. 

Chronic shortages of prescription opioids were finally impacting me directly. 

At first, the pharmacist tried to make it sound like there was just a small delay, asking me, “How how many pills you have left?”

None. I had none left. Because pain medication refills usually aren’t filled until you completely run out. There’s not even a one-day leeway built in, because god forbid pain patients have one extra pill ever. 

Even if I did have some left, I couldn’t tell the pharmacist that, because it might risk having that used against me later. Afterall, if I had extras, that shows that I don’t need to be prescribed as many pills as I was getting. 

You’re always risking something as a pain patient. If you try to plan too far ahead by stockpiling extra pills, they could use that to reduce what you’re prescribed. And if you don’t plan ahead at all, you risk physical pain and withdrawal if there are any issues getting your refill – issues beyond your control like a drug shortage. 

As it turned out, it wouldn’t have mattered if I did have some pills leftover because the situation was worse than the pharmacist was initially letting on. This wasn’t an issue of waiting for an afternoon shipment or even a next-day restock. The pharmacist didn’t know when my medication would be back in stock at all. 

She said she had been requesting more pain medication every day, but their supplier wasn’t providing any updates on a timeline for when that would happen. So she suggested that I call around to other pharmacies to see if any of them had it in stock. 

There’s just one problem: the pain contract I had to sign to get a monthly opioid prescription technically bans me from getting refills at different pharmacies. I don’t think there are any exceptions in the contract. And if I break it, I risk losing access to the only medication that makes it possible for me to function on a daily basis. 

So even if I could find another pharmacy, I wasn’t sure if my doctor would let me get the medication filled there. 

The pharmacist was surprisingly understanding of this, and said that she had already called my doctor before calling me, so she was hopeful that they would be accommodating. 

At that point I realized that any plans I had for my Monday morning were now canceled, because I was going to have to spend the next few hours trying to navigate this. 

I made one last attempt to get the situation resolved without having to loop in another pharmacy, asking if they had an alternative medication that wasn’t too expensive because I don’t have health insurance. My medication is an extended release opioid, and the pharmacists said all they really had was the instant-release versions – which I knew my doctor would not want to swap in.

So, another pharmacy it would have to be. 

I did wonder for a moment if my pharmacy was lying to me about being out of stock. It was just last month that I had to negotiate the price of this same medication with them after they tried to increase the price by $50. 

Maybe they just didn’t want to deal with me, a long-term opioid patient, any more. So after the attempted price increase failed to deter me, they were trying a different tactic. 

The thing is, how would I even find that out? As far as I know, there’s no accountability for pharmacies that lie to patients about why they aren’t able to fill a prescription. Most people understand why that’s concerning when it comes to things like birth control or insulin, but when it’s pain medication, the general public tends to side with the pharmacist who doesn’t want to fill the prescription. 

At that point, I started calling other pharmacies. Thankfully, a locally owned one said they had the medication in stock and that they could fill it. I called my doctor to see if they’d transfer the prescription, and his receptionist took down the message. Then, I waited. 

I spent the next few hours anxious about whether this would all work out, and how long it would be until I got my refill. Finally, at about 1 pm, I saw in MyChart that the medication had been sent to the new pharmacy. 

Then I called the new pharmacy to make sure they saw my prescription come through and to ask what the cash price was. It was going to be $52, about $16 more than I paid at the other pharmacy. I probably could have asked them about using a GoodRx coupon, but I was already throwing a controlled substance prescription on them at the last minute, and they had it in stock, so I didn’t want to make waves. 

A few hours later it was finally filled, sort of. At 3 pm I arrived at the pharmacy to pick it up, after driving 25 minutes on rural roads to get there. 

They handed me the bottle and said, “Oh, by the way, we’re two pills short. Hopefully we will have those in for you later this week. So you can come back and pick them up then.”

Another 50 minutes of round-trip driving was suddenly in my future. 

I’m thankful that I found a pharmacy with any of my medication in stock, and I’m happy that my doctor seemed to handle the prescription transfer without issue. 

What Happens Next Month?

But the entire, stressful ordeal wiped out most of my day, and now I also have to figure out what will happen next month. 

Will the shortage impacting my medication be handled by then? Or should I try to have my doctor switch my prescription to something else? And if he did that, how much would that medication cost? Should I have my prescriptions permanently transferred to the other pharmacy? Is the one I normally go to going to give me a hassle every month now?

If medication shortages don’t impact you directly, it can be easy to gloss over reports like the one from the American Society of Health-System Pharmacists (ASHP), which found that shortages of drugs used for pain, anesthesia, chemotherapy and attention-deficit/hyperactivity disorder (ADHD) “continue to be problematic.” 

Those shortages impact real people. Despite a stressful morning, I was among the lucky ones, as I was able to get it worked out within just one day. Who knows if that will be the case next month though. 

The ASHP cited reduced DEA production quotas and the fallout from opioid litigation as some of the reasons for the drug shortages, which have led to rationing at many pharmacies. In a recent PNN survey, 90% of patients with an opioid prescription said they had trouble getting it filled at a pharmacy.

We need the government to start working on behalf of patients to get this resolved. I can’t just call up the manufacturer of Morphine Sul ER and tell them to make more. It has to be the government that intervenes. 

The best place to start would be to lift the DEA production quotas – although that’s really just a start. If we’re being realistic here, there should also be production minimums, with government funding and support if needed. 

People’s lives depend on these medications. It’s time to stop pretending that these drug shortages are just trivial inconveniences. They’re harmful, and sometimes even deadly.

A Pained Life: Can They Feel What We Feel?

By Carol Levy

How many times have I seen a post or comment in a chronic pain support group that read: “I wish the doctor (or my family, colleagues, friends) could go through this to really understand how I feel.”

I also wish they could, but is there any way such a thing could be accomplished?

Then I read about a course at a Japanese medical school, in which students pretended to be patients and were hospitalized for two days and one night. Students learned firsthand the stress, anxiety and loss of control that comes with being a hospital patient — like being poked and prodded, being told when to sleep, when it was time to get an x-ray, to have blood taken or bandages changed.

Students also observed “the distress of other inpatients” and the “psychological pressure” they felt from physicians. This was meant to enhance their empathy skills and to further their professional development.

It sounds like a good idea. But it's not reality.

Maybe in some form, the course replicates Philip Zimdardo's 1971 prison experiment, in which Stanford students were assigned to be prisoners or guards in a simulated prison. The study was meant to focus on the power of roles and rules, but was ended early because of the behavior that emerged in both groups.

Very quickly the students who were “guards” acted like guards by asserting their control and abusing their power. And many of the “prisoners” acted like prisoners, showing signs of distress from the powerlessness that comes from being ruled by guards

Our pain can also make us feel powerless, especially when it comes to treatment and getting the medications that we need. In that regard, we are indeed powerless. The doctors and pharmacists have all the power.

When we are hospitalized, it often intensifies that feeling of powerlessness. We are “imprisoned” in the hospital and not allowed to leave until someone in power gives us permission. We are in the hands of people who decide what we can do, where we can go, and if our cries of pain will be attended to or not.

They may be called doctors or nurses, but in a very true sense they are guards. Our freedom and health in are in their hands.

Is there really a way to replicate for others how we feel, what we go through?

In a promo for the new TV series “Brilliant Minds,” Dr. Wolf, the main character, says he wants to know what his patients are feeling, so he can feel it himself.

My first thought was that would be great if it was doable. But then I thought about it more deeply. There is no way it could work. A doctor can go into the hospital as a pretend patient, even allow himself to have medically induced pain, but they will always know it is just an experiment. Their pain will end, they can go home when they want, and they will feel fine.

It would make life so much easier for us if others could feel our pain. Absent compassion and empathy, I don't see how it is possible.

Carol Jay Levy has lived with trigeminal neuralgia, a chronic facial pain disorder, for over 30 years. She is the author of “A Pained Life, A Chronic Pain Journey.”  Carol is the moderator of the Facebook support group “Women in Pain Awareness.” Her blog “The Pained Life” can be found here. 

More Americans Have Chronic Pain Than Ever Before

By Pat Anson

Rates of chronic pain and high-impact pain have risen sharply in the United States since the start of the COVID-19 pandemic, which is likely due to an increase in sedentary lifestyles, anxiety and reduced access to healthcare.

In a study preprinted in medRxiv, researchers estimate that 60 million Americans in 2023 had chronic pain, up from 50 million in 2019. The study is based on results from 2019, 2021 and 2023 National Health Interview Surveys (NHIS) of a nationally representative sample of about 88,500 U.S. adults.

Caution is warranted when research is preprinted before undergoing peer-review, but the findings here are startling. Rates of chronic pain (CP) rose from 20.6% in 2019 (before the pandemic), to 20.9% in 2021, and surged to 24.3% in 2023.

High impact chronic pain (HICP), which is pain strong enough to limit daily life and work activity, rose from 7.5% of adults in 2019 to 8.5% in 2023. That translates to 21 million Americans living with debilitating pain.

“Chronic pain and high-impact chronic pain surged dramatically after the COVID pandemic. The widely-cited 20% prevalence of CP in the adult US population appears obsolete,” wrote co-authors Anna Zajacova, PhD, at Western University in Ontario and Hanna Grol-Prokopczyk, PhD, at the University of Buffalo.

“Our findings indicated that chronic pain, already a widespread issue, has reached new heights in the post-pandemic era, necessitating urgent attention and intervention strategies to address and alleviate this growing health crisis.”

The increases in pain occurred in almost all body areas, such as the head, abdomen, back, arms, hands, hips, knees and feet, except for jaw and dental pain. All age groups and both sexes were affected.  

SOURCE: medRxiv

Researchers say being infected with COVID or having long COVID played a significant role in the increases, but social and economic causes may have also been at work. Pain could have worsened due to anxiety, depression, loneliness, physical inactivity and reduced access to health care, as well as inflation and economic hardships caused by the pandemic.

“The 2023 surge is not restricted to specific demographics or body sites — it is widespread across the population subgroups and affects all examined pain sites except jaw/dental pain. Further, the increase persisted even after accounting for potential drivers such as COVID-19 infections, socioeconomic factors, and other potentially important covariates such as mental health or health behaviors. This suggests that a broader, more complex set of factors may be at play,” researchers reported.

“Thus, while the viral infections certainly had an impact, other societal and lifestyle changes that occurred during and after the pandemic may have contributed to the increase in pain. The role of increased social isolation and loneliness, disrupted health care access, and heightened levels of stress and anxiety, all of which were exacerbated by the pandemic, should be explored in future research.”

Although chronic pain rates have surged over the last few years, there has been little response from healthcare providers and regulators. In fact, the just opposite happening. The Food and Drug Administration predicted a 7.9% decline in medical need for opioid pain medication in 2024, and anticipates a 6.6% decrease in demand next year.

The Drug Enforcement Administration uses those FDA estimates when setting its annual production quotas for opioids, which have fallen for eight straight years. Since 2015, the supply of oxycodone has been reduced by over 68% and hydrocodone by nearly 73%.

Many pain patients feel like they’ve been abandoned by the healthcare system, according to a 2023 PNN survey of nearly 3,000 patients or caregivers. About one in five patients have been unable to find a doctor to treat their pain, and 12% say they were abandoned or discharged by a doctor. Many are now hoarding opioid medication or turning to other substances for relief.

Those findings from our survey are now being reflected in the study on rising pain rates.

“The findings are a call to action for public health professionals, policymakers, and researchers to further investigate the root causes of this increase. Addressing the rise in chronic pain is critical, as pain serves as a sensitive barometer of population health and has profound economic, social, and health consequences,” said Zajacova and Hanna Grol-Prokopczyk.

Where Did the Opioid Settlement Money Go?

By Crystal Lindell

How are states spending their opioid settlement money? Unsurprisingly, it’s often hard to say – even when a state has promised transparency. 

Federal, state and local governments in the United States will collect about $50 billion in opioid settlement money in coming years from basically every sector of the health care industry, including drug makers, wholesale distributors and pharmacies. 

But an investigation of 12 states by NPR and KFF Health News found that it’s unclear how much of that money is being used to prevent addiction or to help people with substance abuse issues. 

As a pain patient, I have long assumed that none of the settlement money would be used to develop effective, non-opioid pain analgesics for patients who lost their medication as a result of opioid-phobia. Based on how everything around opioids has played out over the years, I also didn’t have high hopes for what it would actually get spent on.

The NPR/KFF Health News investigation shows that I was correct to worry. 

“There are no national requirements for jurisdictions to report money spent on opioid remediation,” Aneri Pattani reported.”In states that have not enacted stricter requirements on their own, the public is left in the dark or forced to rely on ad hoc efforts by advocates and journalists to fill the gap.”

Pattani shared a story about the situation in Idaho, where local governments were required to complete a form showing how they spent settlement money and whether it was for an approved purpose. But a process meant to show transparency seemed to do just the opposite. 

“In reality, it reads like this,”said Pattani. “In fiscal year 2023, the city of Chubbuck spent about $39,000 on Section G, Subsection 9. Public Health District No. 6 spent more than $26,000 on Section B, Subsection 2. Cracking that code requires a separate document. And even that provides only broad outlines.”

Pattani said that following the money trail just led to more intentionally confusing bureaucratic language. 

For example, she found that Subsection 9 refers to “school-based or youth-focused programs or strategies that have demonstrated effectiveness in preventing drug misuse.” 

Subsection 2 refers to “the full continuum of care of treatment and recovery services for OUD and any co-occurring SUD/MH conditions.” 

“What does that mean? How exactly are you doing that?” Corey Davis, a project director at the Network for Public Health Law, wondered when he first saw the Idaho reports. Without detailed descriptions of the projects the money was spent on, it’s impossible to track. 

“It’d be similar to saying 20% of your monthly salary goes to food,” Pattani wrote. “But does that mean grocery bills, eating out at restaurants, or hiring a cook?” 

Minnesota’s ‘Dashboard’

Some states are more transparent about where the money is going. Minnesota, for example, has an online dashboard and downloadable spreadsheet listing projects. One project was in Renville County, which used $100,000 to install a body scanner in its jail to help staff find drugs in the body cavities of inmates.

So, cops are getting the money. And when you look around on the Minnesota dashboard, it becomes clear that law enforcement agencies got some of the largest shares of the state’s opioid settlement money.  

So far, Minnesota has received over $74 million in settlement money. Of that, law enforcement-related categories received about $17 million, coming in fourth behind "American Indian" with $32.6 million, “African or African American" with $22.6 million, and "Child protection” which received $22.65 million. 

I was pleasantly surprised to see that Minnesota does have a "Chronic pain patients" category — but then was disappointed to learn that it got the least amount of money of any group, receiving just $290,180 of the state’s settlement funds.

When I drilled down deeper on the chronic pain category, things only got more depressing. 

The bulk of that money ($257,220) went to Hennepin Health System to "expand access to holistic chronic pain treatment through Heals on Wheels program,” which includes traveling clinics that provide training in mindfulness, stress management, mindful movement, acupressure, acupuncture and massage therapy.

The remaining $32,960 went to a group called Health Partners, which said it would use the money to, "Certify 10 clinicians to provide Empowered Relief, a one-session class that equips patients with pain management skills, draws on principals from mindfulness and cognitive behavior therapy.” 

As a pain patient, finding out that the very small amount of Minnesota’s opioid money going to pain patients is being used to fund BS about mindfulness is beyond infuriating. We need real treatments, not happy thoughts.

Of course, in other states, it’s hard to even know how much money is going to cops and if any is going to chronic pain patients, so I guess I should be happy that there’s at least some record of things in Minnesota.  

Interestingly, over $1.9 million of Minnesota’s settlement money went to the Steve Rummler Hope Foundation, primarily for opioid education and naloxone distribution. 

Coincidentally, the Rummler Foundation happens to be the fiscal sponsor of Physicians for Responsible Opioid Prescribing (PROP), an anti-opioid activist group that played an instrumental role in raising fears about opioid use and addiction.

Several PROP members worked as paid expert witnesses for plaintiff law firms that pursued opioid litigation on behalf of the states, and were paid as much as $850 an hour for their services. The law firms themselves will pocket billions of dollars in contingency fees once all the funds are paid. That kind of detail is rarely mentioned in reporting on how settlement money is used.   

So while some details of how opioid funds were spent are technically available to the public, Pattani says it doesn’t matter if finding them requires hours of research and wading through budgetary jargon.

“Not exactly a system friendly to the average person,” she said.

Of course, if any of the opioid settlement money was ever actually meant to help people who may have been harmed by opioids, it wouldn’t be going to governments – it would be going directly to opioid users or their surviving loved ones.

But it’s been clear from the beginning that these opioid settlements were primarily a cash grab for state and local governments, plaintiff law firms, and their expert witnesses. They don’t help patients and they don’t help their loved ones. 

I don’t expect any of the states to increase transparency about where the money has been going. Most of the general public doesn’t care, so the states can funnel a lot of the money into things like body scanners, because they don’t have the pesky public watching what they’re doing. 

Maybe next time when we decide to sue every pharmaceutical company and pharmacy chain in the country, we could at least make it class action lawsuits on behalf of patients, not governments.

Return to Sender: WIll Anyone Use FDA’s New Opioid Mail-Back Program?

By Crystal Lindell

The DEA has been hosting drug “Take Back Days” for over a decade, collecting over 9,200 tons of unwanted or expired prescriptions and over-the-counter medicines. The take-back program is seen as a key effort to prevent drug diversion and opioid addiction.

Now the Food and Drug Administration is expanding its own drug collection program – essentially making every day an opioid take-back day.  

Starting on March 31, 2025, drug makers participating in the FDA’s Opioid Analgesic Risk Evaluation and Mitigation Strategy (REMS)  – which means every company that makes and sells opioids – will be required to provide pre-paid, drug mail-back envelopes “upon request” to pharmacies that dispense opioids. The pharmacies then have to give the envelopes to patients and caregivers who ask for them, so they can mail back any unwanted opioids. 

The fact that both pharmacies and patients have to request these envelopes makes me skeptical about how much this program will actually be used.

The press release from the FDA includes a quote that sounds surprisingly pro-patient though. So even if the program doesn’t have a high use-rate, perhaps an extra measure of safety will make it easier for patients to get opioid prescriptions. 

“We want to ensure patients have access to opioid analgesics in their pain management regimens and that they are educated about methods available to safely dispose of any leftover medicines, which could pose a real danger to their loved ones and pets,” said Marta Sokolowska, PhD, deputy center director for Substance Use and Behavioral Health at the FDA Center for Drug Evaluation and Research.  

It’s the part about ensuring that “patients have access to opioid analgesics” that stands out to me. Patients certainly need access to opioid pain meds. And if programs like this help doctors and medical professionals feel more comfortable prescribing opioids, then I fully support them. 

But I’m skeptical about whether that will be the actual outcome. The real question is whether anyone will use the mail-back program. 

The DEA has never released a full breakdown of the medications returned during its drug take-back days. But an analysis of the drugs returned at a take-back day in Lansing, Michigan in 2013 provides some insight. 

Of the nearly 2,500 medication containers that were returned, only 304 were for a controlled substance like opioids – about 12% overall. The most common types of medication returned were for pain/spasm, cardiovascular, and mental health conditions.

While hydrocodone/acetaminophen combinations (Norco) were the most returned medication at that 2013 event, it represented just 4.4% of all returned containers. 

The second most-common drug returned was ibuprofen (Advil) in 2.2% of the containers. Acetaminophen (1.7%) and aspirin (1.3%) also made the top ten list of most-returned medications. 

Something tells me that Advil isn’t what organizers had in mind when they asked people to bring in their unused drugs. 

In the end, the FDA’s new mail-back program will likely have a greater impact as a public relations initiative to make the agency look good, rather than keeping unwanted opioids off the street. 

In a world where doctors are so reluctant to prescribe opioids, I don’t blame people for wanting to hold on to the opioids they’re able to get. In a PNN survey of thousands of pain patients, nearly a third (32%) admitted hoarding their unused opioids because they’re unsure if they’ll be able to get them in the future 

If we’re lucky, the program will accomplish at least one of the goals that the FDA’s Sokolowska laid out: “We want to ensure patients have access to opioid analgesics.”

Given the federal government's abysmal track record with opioids and pain care in general, I’ll believe that when I see it.

What Will Trump’s White House Return Mean for Healthcare?

By Stephanie Armour, KFF Health News

Former President Donald Trump’s election victory and looming return to the White House will likely bring changes that scale back the nation’s public health insurance programs — increasing the uninsured rate, while imposing new barriers to abortion and other reproductive care.

The reverberations will be felt far beyond Washington, DC, and could include an erosion of the Affordable Care Act’s consumer protections, the imposition of work requirements in Medicaid and funding cuts to the safety net insurance, and challenges to federal agencies that safeguard public health. Abortion restrictions may tighten nationwide with a possible effort to restrict the mailing of abortion medications.

And with the elevation of vaccine skeptic Robert F. Kennedy Jr. to Trump’s inner circle of advisers, public health interventions with rigorous scientific backing — whether fluoridating public water supplies or inoculating children — could come under fire.

Trump defeated Vice President Kamala Harris with 277 Electoral College votes, The Associated Press declared at 5:34 a.m. ET on Wednesday. He won 51% of the vote nationally to Harris’ 47.5%, the AP projected.

Trump’s victory will give a far broader platform to skeptics and critics of federal health programs and actions. Worst case, public health authorities worry, the U.S. could see increases in preventable illnesses; a weakening of public confidence in established science; and debunked notions — such as a link between vaccines and autism — adopted as policy.

Trump said in an NBC News interview on Nov. 3 that he would “make a decision” about banning some vaccines, saying he would consult with Kennedy and calling him “a very talented guy.”

‘Concepts of a Plan’

While Trump has said he will not try again to repeal the Affordable Care Act, his administration will face an immediate decision next year on whether to back an extension of enhanced premium subsidies for Obamacare insurance plans. Without the enhanced subsidies, steep premium increases causing lower enrollment are projected. The current uninsured rate, about 8%, would almost certainly rise.

Policy specifics have not moved far beyond the “concepts of a plan” Trump said he had during his debate with Harris, though Vice President-elect JD Vance later said the administration would seek to inject more competition into ACA marketplaces.

Republicans were projected to claim a Senate majority, in addition to the White House, while control of the House was not yet resolved early Wednesday.

Polls show the ACA has gained support among the public, including provisions such as preexisting condition protections and allowing young people to stay on family health plans until they are 26.

Trump supporters and others who have worked in his administration say the former president wants to improve the law in ways that will lower costs. They say he has already shown he will be forceful when it comes to lowering high health care prices, pointing to efforts during his presidency to pioneer price transparency in medical costs.

“On affordability, I’d see him building on the first term,” said Brian Blase, who served as a Trump health adviser from 2017 to 2019. Relative to a Democratic administration, he said, there will be “much more focus” on “minimizing fraud and waste.”

Efforts to weaken the ACA could include slashing funds for enrollment outreach, enabling consumers to purchase more health plans that don’t comply with ACA consumer protections, and allowing insurers to charge sicker people higher premiums.

Democrats say they expect the worst.

“We know what their agenda is,” said Leslie Dach, executive chair of Protect Our Care, a health care policy and advocacy organization in Washington, D.C. He worked in the Obama administration helping to implement the ACA. “They’re going to raise costs for millions of Americans and rip coverage away from millions and, meanwhile, they will give tax breaks to rich people.”

Theo Merkel, director of the Private Health Reform Initiative at the right-leaning Paragon Health Institute, which Blase leads, said the enhanced ACA subsidies extended by the Inflation Reduction Act in 2022 do nothing to improve plans or lower premiums. He said they paper over the plans’ low value with larger government subsidies.

Other Trump supporters say the president-elect may support preserving Medicare’s authority to negotiate drug prices, another provision of the IRA. Trump has championed reducing drug prices, and in 2020 advanced a test model that would have tied the prices of some drugs in Medicare to lower costs overseas, said Merkel, who worked in Trump’s first White House. The drug industry successfully sued to block the program.

Within Trump’s circles, some names have already been floated as possible leaders for the Department of Health and Human Services. They include former Louisiana Gov. Bobby Jindal and Seema Verma, who ran the Centers for Medicare & Medicaid Services during the Trump administration.

Kennedy, who suspended his independent presidential run and endorsed Trump, has told his supporters that Trump promised him control of HHS. Trump said publicly before Election Day that he would give Kennedy a big role in his administration, but he may have difficulty winning Senate confirmation for a Cabinet position.

While Trump has vowed to protect Medicare and said he supports funding home care benefits, he’s been less specific about his intentions for Medicaid, which provides coverage to lower-income and disabled people. Some health analysts expect the program will be especially vulnerable to spending cuts, which could help finance the extension of tax breaks that expire at the end of next year.

Possible changes include the imposition of work requirements on beneficiaries in some states. The administration and Republicans in Congress could also try to revamp the way Medicaid is funded. Now, the federal government pays states a variable percentage of program costs. Conservatives have long sought to cap the federal allotments to states, which critics say would lead to draconian cuts.

“Medicaid will be a big target in a Trump administration,” said Larry Levitt, executive vice president for health policy at KFF, a health information nonprofit that includes KFF Health News.

Less clear is the potential future of reproductive health rights.

Trump has said decisions about abortion restrictions should be left to the states. Thirteen states ban abortion with few exceptions, while 28 others restrict the procedure based on gestational duration, according to the Guttmacher Institute, a research and policy organization focused on advancing reproductive rights. Trump said before the election that he would not sign a national abortion ban.

State ballot measures to protect abortion rights were adopted in four states, including Missouri, which Trump won by about 18 points, according to preliminary AP reports. Abortion rights measures were rejected by voters in Florida and South Dakota.

Trump could move to restrict access to abortion medications, used in more than half of abortions, either by withdrawing the FDA’s authorization for the drugs or by enforcing a 19th-century law, the Comstock Act, that abortion opponents say bans their shipment. Trump has said he generally would not use the law to ban mail delivery of the drugs.

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