Can Exercise Help Relieve Shoulder Pain?

By Drs. Marc-Olivier Dubé, François Desmeules and Jean-Sébastien Roy

It is estimated that close to 70 per cent of the population will experience shoulder pain at some point in their lives.

This pain would not pose a problem if it disappeared as quickly as it appeared. Unfortunately, shoulder pain tends to persist over time. In half of patients, the pain lingers or reoccurs one year after its initial appearance. It can even persist for several years in some cases.

Approximately 70 per cent of shoulder pain episodes requiring consultation with a health-care provider can be identified as rotator cuff related shoulder pain. This refers to pain and loss of function in the shoulder, mainly during movements requiring the arm to be lifted. Although a number of effective options are available to patients, a third of them will not experience any significant improvement in their condition, regardless of the interventions used.

There are several possible reasons for this limited success. Exercise selection and some psychological and contextual characteristics specific to each individual have been identified as potential hypotheses.

As experts in the field of shoulder pain, we propose to shed light on the effectiveness of various interventions for the management of shoulder pain, and the role that some variables may play in the resolution of this pain.

Our research team therefore set out to find out:

1. Whether one type of exercise should be prioritized over another in the management of shoulder pain.

2. Whether the addition of exercises (the pet peeve of many people who consult a rehabilitation provider) lead to additional benefits compared with an intervention comprising only of education and advice to foster pain self-management.

3. Whether some psychological and contextual characteristics, such as participants’ expectations of the intervention effectiveness and pain self-efficacy, are associated with a better prognosis.

Pain self-efficacy is the level of confidence someone has in their ability to carry out their activities and achieve their goals despite pain.

What We Found

In our new study published in the British Journal of Sports Medicine, 123 people with shoulder pain lasting for more than three months were randomly assigned to one of three 12-week interventions:

1. Education

2. Education combined with motor control exercises

3. Education combined with strengthening exercises

Questionnaires were used to monitor changes in participants’ condition over time, particularly in terms of their pain and functional capacity.

Before the start of the intervention, we also used questionnaires to measure participants’ expectations of the effectiveness of the intervention they were about to receive, as well as their level of pain self-efficacy.

Education: Participants in this group received two sessions of education and advice with a physiotherapist. The information was about the shoulder and pain, and the advice included strategies for the self-management of their condition.

Participants were also told about the importance of being active and adopting a healthy lifestyle to optimize the management of persistent pain, including proper diet, hydration, stress management and sleep hygiene.

Finally, participants were asked to watch six short videos on these themes. Here’s one:

After viewing, they were asked to identify the aspects they felt were important and those that raised questions in order to discuss them with the physiotherapist.

Education combined with motor control exercises: Participants in this group completed a 12-week program that combined education with exercises.

The exercises included modifications in the way they performed their movements to enable them to move their arm with less pain. These modifications were integrated with exercises reproducing gestures involving the shoulder during daily activities.

Education combined with strengthening exercises: Participants in this group received the same education component, along with  a shoulder muscle strengthening program to be performed daily for 12 weeks.

At the end of the study, participants in all three groups showed improvements in pain and function. However, the addition of exercises (motor control or strengthening) to the education intervention did not lead to additional benefits.

People recruited into the study whose symptoms were considered resolved following the 12-week intervention had more positive expectations regarding the effectiveness of their intervention and had higher levels of pain self-efficacy.

Key Takeaways

Adding strengthening or motor control exercises to an educational intervention did not result in additional benefits compared to an approach based solely on education and advice. For some people with persistent shoulder pain, education and advice focusing on pain self-management may be sufficient to promote symptom resolution.

Exercise, in any form, remains a highly relevant intervention for shoulder pain management, as well as for maintaining independence and optimizing long-term health.

Participants’ pain self-efficacy and expectations of the effectiveness of the intervention they receive may play a role in the prognosis of their shoulder pain.

When you’re experiencing shoulder pain, it can be beneficial to temporarily reduce certain activities that can aggravate your pain. However, it’s important not to delay gradually reintegrating these activities into your daily routine.

The presence of pain, especially when it persists over time, is not necessarily a sign that your condition is deteriorating. It could simply indicate that the gestures or activities performed exceed the shoulder’s current ability to tolerate the load imposed on it.

In any case, don’t hesitate to consult a health professional, such as a physiotherapist, who will be able to help you “shoulder” the responsibility of managing your condition.

Marc-Olivier Dubé, PhD, is a Physiotherapist and Postdoctoral researcher in rehabilitation at Laval University.

Francois Desmeules, PhD, is a professor in physiotherapy and musculoskeletal health, School of Rehabilitation, University of Montréal.

Jean-Sébastien Roy, PhD, is a professor at the School of Rehabilitation Sciences, Laval University.

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

There’s an App for That

By Barby Ingle, PNN Columnist

Have you noticed that many healthcare companies, medical providers and support groups now have apps for patients?

A recent survey found that about 40% of U.S. adults use healthcare apps and 35% use wearable devices to track their fitness, sleep, diet and other health-related activities. The market for healthcare apps was estimated to be worth $10 billion in 2022 and is expected to grow to $41 billion by 2030.

There are some great “patient-centric” apps. Patient-centric or "person-centered care" means the technology approaches healthcare in a manner that directly involves patients. I have used apps to track my eating, hydration, movement, medications, sleep time and more. Some apps can also help you organize your medical care and recognize issues or changes needed in your medical records.

Patient Portal Apps

The patient portal apps I suggest below are typically set up by the provider, and then the patient can log in and check their records, set up appointments, and access other resources. There are many choices for medical providers to use for patient portals, but these seem to be the ones used the most:  

• HealthTap: This telehealth app connect patients with primary care doctors for online care. Patients can use HealthTap for checkups, prescriptions, lab tests, treatment plans, and specialist referrals. They take patients with and without insurance. Costs start as low as $15 a month, making this affordable for even those without insurance.

• MyChart: This one is my personal favorites and I use it often, as do most of my providers in Arizona. I used MyChart this morning to check on my appointments and to pay an outstanding balance. This app can also give friends and family access to your medical records if you choose. It is excellent for parents to take care of their children and other family members from one account. It will store your medical and lab records, and even some images from MRIs, x-rays, etc. There is transparency in who has accessed your medical records, so you will know which providers have this information.

• FollowMyHealth: This app allows patients to access their medical records, request prescriptions, schedule appointments, and send messages to medical providers and staff. FollowMyHealth can also connect with medical devices such as glucose, heart and blood pressure monitors, and digital scales.

Apps for General Health 

There are many apps for overall general health, with the most popular ones being Headspace, Talkspace, Doctor on Demand, Sleep Cycle, My Fitness Pal, Fooducate, Teladoc, Fitbit, Noom, mySugr, and WebMD.  I have used many of them, but I will focus on my top three:  

• Fitbit: I never considered using a Fitbit watch until I won one from the WEGO Health Awards (now Health Union). I quickly got more involved in tracking my life by using the device. I loved how it could track my movement, sleep and stress levels, and allowed me to put in notes on things such as hydration, migraines and gastrointestinal challenges. I also like Fitbit’s PurePulse, which tracks blood flow and heart rate. FitBit devices range from $80 to $300 each.

• Noom: This is a subscription-based app that helps users track their food intake and exercise. Noom uses psychology to help users develop healthy eating and physical activity habits to lose weight. It takes a lot of dedication and focus to use Noom successfully. I lost over 20 pounds using it. I am not very active physically, and they considered that in developing an individualized program for me as a chronic pain and rare disease patient. The app encourages you to think about food differently and change your eating habits so your body works better for you. The average subscription is $60 monthly.  

• Sleep Cycle: This app tracks and analyzes your sleeping patterns. It was helpful for me to take sleep data from the app to my primary care provider so he could better understand why I have trouble sleeping. I do not sleep consistently through the night, especially on high-pain days. It’s a good tool to figure out why you are struggling to sleep and how pain is affecting your internal clock or waking you up. The Sleep Cycle app is free to download, but a premium subscription costs $40 per year. I used the free accessible portions of the app at no cost.

Chronic Pain Apps

There are many apps that can help a patient track their pain levels, types of pain, whether treatment options are helping or hurting, and more. I used to do this the old-fashioned way with a journal, but having digital data to break it down scientifically for my providers was helpful once I started using pain-tracking apps. I have tried a few and heard others find them helpful as well.  

• PainChek: This app uses artificial intelligence (AI) and facial expressions to assess pain in people who cannot reliably communicate their pain levels, such as those with dementia or young children. PainChek uses a smartphone camera to analyze a person's face. The AI system then automatically recognizes and documents facial movements that indicate pain. It’s more of an objective tool for me, since I can speak about my pain, but for those who are voiceless, it could help their daily life and individualize their care. 

• Vivify:  This is a 28-day program for people with chronic back or neck pain that includes pain education, meditation, exercises, and guided walks through an app or website connection. Vivify also monitors patients remotely, allowing providers to create and manage wellness programs for their patients. Although the goal is to “overcome or remove chronic pain entirely,” I see this app as more of a tool for people to assist in their daily activities and motivate them to move.

• My Pain Diary:  This pain-tracking app reminds me of when I used to manually keep track of my pain before apps were available. It gives patients a way to document and track their pain triggers and symptoms. You can also use the data to print detailed reports that are easy to share with your providers. I like the color-coded calendar, graphs and searchable history. The app looks at the data and sees trends you may not notice yourself. The Gold Edition of My Pain Diary costs just $5.

• PainScale: This app was recommended to me by a friend. PainScale is made by Boston Scientific and helps users track their pain, suggests treatment options, and generate reports to providers. It can also provide information from the Mayo Clinic, WebMD and other trusted pain resources to help patients manage chronic pain triggers. This app is free to download.  

The apps mentioned above are some of the most used and trusted apps by patients and providers. Patient-centric apps have become an essential part of the healthcare industry. As technology and AI continue to advance, we can expect to see more of these innovative patient apps in the future.

Barby Ingle is a reality TV personality living with multiple rare and chronic diseases. She is a chronic pain educator, patient advocate, motivational speaker, and the founder and former President of the International Pain Foundation. You can follow Barby at www.barbyingle.com. 

Family Caregivers Face Financial Burdens, Isolation and Burnout

By Dr. Kathy Lee, University of Texas at Arlington

Millions of Americans have become informal family caregivers: people who provide family members or friends with unpaid assistance in accomplishing daily tasks such as bathing, eating, transportation and managing medications.

Driven in part by a preference for home-based care rather than long-term care options such as assisted living facilities, and the limited availability and high cost of formal care services, family caregivers play a pivotal role in the safety and well-being of their loved ones.

Approximately 34.2 million people in the United States provide unpaid assistance to adults age 50 or above, according to the Family Caregiver Alliance. Among them, about 15.7 million adult family caregivers care for someone with dementia.

Help celebrate National Caregivers Day (Feb. 16) by thanking someone who cares for a disabled loved one.

Challenging Situations

I am a licensed clinical social worker and an assistant professor of social work studying disparities in health and health care systems. I focus on underrepresented populations in the field of aging.

In my research focusing on East Asian family caregivers for people with Alzheimer’s and related dementia, I discovered that Chinese American and Korean American caregivers often encounter challenging situations. These include discrimination from health care facilities or providers, feelings of loneliness and financial issues. Some of these caregivers even find themselves having to retire early because they struggle to balance both work and caregiving responsibilities.

My findings join a growing body of research showing that family caregivers commonly encounter five specific challenges: financial burdens, limited use of home- and community-based services, difficulties accessing resources, a lack of knowledge about existing educational programs, and physical and emotional challenges, such as feelings of helplessness and caregiver burnout.

However, researchers are also finding that family caregivers feel more capable of managing these challenges when they can tap into formal services that offer practical guidance and insights for their situations, as well as assistance with some unique challenges involved with family caregiving.

Most Caregivers Are Women

More than 6 in 10 family caregivers are women.

Society has always expected women to take on caregiving responsibilities. Women also usually earn less money or rely on other family members for financial support. This is because equal pay in the workplace has been slow to happen, and women often take on roles like becoming the primary caregiver for their own children as well as their aging relatives, which can drastically affect their earnings.

While nearly half of care recipients live in their own homes, 1 in 3 live with their caregivers.

Sometimes termed “resident caregivers,” these individuals are less likely to turn to others outside the family for caregiving support, often because they feel that it’s important to keep caregiving within the family. These caregivers are typically older, retired or unemployed and have lower income than caregivers who live separately.

According to a 2020 report from the AARP Public Policy Institute, about 1 in 3 family caregivers provide more than 21 hours of care a week to a loved one.

Support Programs for Caregivers

Caregiving often creates financial burdens because it makes it harder to hold a full-time or part-time job, or to return to work after taking time off, particularly for spouses who are caregivers.

Often, community-based organizations such as nonprofits that serve older adults offer a variety of in-home services and educational programs. These can help family caregivers manage or reduce the physical and emotional strains of their responsibilities. However, these demands also can make it difficult for some caregivers to even learn that these resources exist, or take advantage of them, particularly as the care recipient’s condition progresses.

These challenges worsened at the height of the COVID-19 pandemic. Many support programs were canceled, and it was hard to access health care, which made things even more stressful and tiring for caregivers.

Research shows that those who are new to family caregiving often take care of their loved ones without any formal support initially. As a result, they may face increased emotional burdens. And caregivers age 70 and above face particular challenges, since they may be navigating their own health issues at the same time. These individuals are less likely to receive informal support, which can lead to social isolation and burnout. 

There are numerous programs and services available for family caregivers and their loved ones, whether they reside at home or in a residential facility. These resources include government health and disability programs, legal assistance and disease-specific organizations, some of which are specific to certain states.

In addition, research has found that providing appropriate education and training to people in the early stages of caregiving enables them to better balance their own health and well-being with successfully fulfilling their responsibilities. Many community-based organizations, such as local nonprofits focused on aging, as well as government programs or senior centers, may offer case management services for older adults, which can be beneficial for learning about existing resources and services.

For family caregivers of people with dementia, formal support services are particularly crucial to their ability to cope and navigate the challenges they face.

Formal support may also be helpful in finding affordable home-based and community resources that can help compensate for a lack of informal support. These include home health services funded by Medicare and Medicaid-funded providers of medical and nonmedical services, including transportation.

Medicaid, which targets low-income Americans, seniors, people with disabilities and a few select other groups, has certain income requirements. Determine the eligibility requirements first to find out whether your loved one qualifies for Medicaid.

The services and support covered by Medicaid may vary based on a number of factors, such as timing of care, the specific needs of caregivers and their loved ones, the care plan in place for the loved one and the location or state in which the caregiver and their loved one reside.

Each state also has its own Medicaid program with unique rules, regulations and eligibility criteria. This can result in variations in the types of services covered, the extent of coverage and the specific requirements for accessing Medicaid-funded support.

If so, contact your state’s Medicaid office to get more information about self-directed services and whether you can become a paid family caregiver.

Medicare may help pay for certain home health services if an older adult needs skilled services part time and is considered homebound.

This assistance can alleviate some of the caregiving responsibilities and financial burdens on the family caregiver, allowing them to focus on providing care and support to their loved ones without worrying about the cost of essential medical services.

Peer-to-peer support is also crucial. Family caregivers who join support groups tend to manage their stress more effectively and experience an overall better quality of life.

Kathy Lee, PhD, is an Assistant Professor of Gerontological Social Work at University of Texas at Arlington. Her primary focus lies in exploring innovative and non-pharmacological interventions for individuals living with Alzheimer's disease and related dementias, as well as providing support for their family caregivers.

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

Dietary Supplements Need More Regulation

By Emily Hemendinger and Katie Suleta

Dietary supplements are a big business. The industry made almost $39 billion in revenue in 2022, and with very little regulation and oversight, it stands to keep growing.

The marketing of dietary supplements has been quite effective, with 77% of Americans reporting feeling that the supplement industry is trustworthy. The idea of taking your health into your own hands is appealing, and supplements are popular with athletes, parents and people trying to recover more quickly from a cold or flu, just to name a few.

A 2024 study found that approximately 1 in 10 adolescents have used nonprescribed weight loss and weight control products, including dietary supplements.

Notably, that systematic review found that nonprescribed diet pill use was significantly higher than the use of nonprescribed laxatives and diuretics for weight management. These types of unhealthy weight control behaviors are associated with both worsened mental health and physical health outcomes.

As a licensed clinical social worker specializing in treating anxiety disorders and eating disorders and a biomedical research director, we’ve seen firsthand the harm that these supplements can do based on unfounded beliefs. The underregulated market of dietary supplements is setting consumers up to be misled and potentially seriously harmed by these products.

Supplements Often Mislabeled

The Food and Drug Administration specifies that supplements must contain a “dietary ingredient” such as vitamins, minerals, herbs, amino acids, enzymes, live microbials, concentrates and extracts, among others.

Unfortunately, manufacturers can claim that a product is a supplement even when it doesn’t meet those criteria, such as products containing the drug tianeptine, a highly addictive drug that can mimic the biological action of opioids. Some of these products are labeled as dietary supplements but are anything but.

Products containing kratom, a substance with opioid-like effects, which are sold over the counter in many gas stations, claim to be herbal supplements but are mislabeled.

Under a 1994 law, dietary supplements are classified as food, not as drugs. This means dietary supplements are not required to prove efficacy, unlike drugs. Regulators also don’t take action on a product until it is shown to cause harm.

However, the FDA’s website states that “many dietary supplements contain ingredients that have strong biological effects which may conflict with a medicine you are taking or a medical condition you may have. Products containing hidden drugs are also sometimes falsely marketed as dietary supplements, putting consumers at even greater risk.”

In other words, supplements are regulated as food instead of drugs, even though they can interact with medications and may be laced with hidden drugs not included on the label.

Manufacturers of dietary supplements can make claims about their products that fall into three categories: health claims, nutrient content claims and claims about the product’s function, structure or both, all without needing to provide supporting evidence.

Misbranding and false advertising are rampant with dietary supplements, including false claims of curing cancer, improving immune health, improving cognitive functioning, improving fertility, improving cardiovascular health and, of course, promoting weight loss and weight control.

Hidden Dangers

You can find supplements that claim to be good for just about every health condition, concern or goal, so it should be no surprise that there are supplements marketed for weight loss.

In August 2021, the FDA cracked down on some of these weight loss products because of the presence of undeclared drugs. For example, of the 72 products recalled, the drug sibutramine, sold as Meridia, was found in 68 of them.

While the FDA may take further action beyond the recalls, the agency acknowledged that it is not able to test every weight loss supplement for contamination with drugs.

These crackdowns demonstrate some progress, though several issues remain. Warning label placement, ingredients and beliefs based on misleading or false advertising are still highly problematic.

Some weight loss supplements may have FDA warnings on them. Of those that do, the disclaimers are rarely displayed on the front of the product label, so consumers are less likely to see them.

Ingredients in weight loss supplements can and do have adverse effects. They have caused people to be admitted to the emergency room for cardiovascular and swallowing problems, including in young, seemingly healthy people.

Mental health concerns and eating disorders are on the rise. As a result, researchers are examining unhealthy weight control behaviors, including the use of dietary supplements and how accessible they are to adolescents and children.

People who have eating disorders often suffer related health issues such as bone loss, osteoporosis and vitamin deficiencies. In response, their doctors may prescribe dietary supplements like calcium, vitamin D and nutritional supplement shakes. But these are not the dietary supplements of concern. The concern is with supplements that promote weight loss, muscle building or both.

People with eating disorders may be attracted to dietary supplements that claim quick and pain-free weight loss or muscle gain. Additionally, dietary supplement users may struggle with an increase in compulsive exercise or other unhealthy weight control behaviors.

Diet pill and supplement use has also been associated with increased risk for developing eating disorders and disordered eating, as well as low self-esteem, depression and substance use. While dietary supplements do not solely cause eating disorders or disordered eating, they are one contributing factor that may be addressed with preventive measures and regulations.

Protein powders and other fitness supplements also have wide appeal. Research shows that girls are more at risk than boys for using weight loss supplements. But a growing problem in boys is the use of fitness supplements such as protein powder and creatine products, a compound that supplies energy to the muscles.

Use of fitness supplements sometimes signifies a preoccupation with body shape and size. For example, a 2022 study found that protein powder consumption in adolescence was associated with future use of steroids in emerging adulthood.

Protein powders make claims of building lean muscles, while creatine boasts providing energy for short-term, intense exercise.

Protein itself is not harmful at recommended doses. However, protein powders may contain unknown ingredients, such as certain toxins or extra and excessive sugar. They can also be dangerous when used in excess and to replace other foods that possess vital nutrients.

And while creatine can usually be safely used in adults, overuse can lead to health problems and is not recommended for minors. Ultimately, the impact of long-term use of these supplements, especially in adolescents, is unstudied.

Possible Solutions

One proposed regulation by researchers at Harvard University includes taxing dietary supplements whose labels tout weight loss benefits.

Another policy recommendation involves banning the sale of dietary supplements and other weight loss products to protect minors from these underregulated and potentially dangerous products.

In 2023, New York successfully passed legislation that banned the sale of these products to minors, while states including Colorado, California and Massachusetts have considered or are considering similar action.

Ultimately, medical professionals recommend that parents and caregivers encourage their children to get protein and vitamins from whole foods instead of turning to supplements and powders. They also recommend encouraging teens to focus on balanced nutrition, sleep and recovery, and a variety of resistance, strength and conditioning training.

Emily Hemendinger, LCSW, is an Assistant Professor of Psychiatry at University of Colorado Anschutz Medical Campus.

Katie Suleta is a PhD Candidate in Medicine and Health at George Washington University.

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

Americans Are Using More Alternative Pain Therapies

By Pat Anson, PNN Editor

It’s fair to say that almost every person living with chronic pain has been told by a doctor, loved one, friend or even strangers that they should try a “complimentary health approach” to pain management. Also known as a “multimodal” or “comprehensive” care, the idea is to get pain patients to reduce or stop using opioids and other medications by utilizing alternative health therapies such as massage, meditation and acupuncture.

A new study shows that there has been surge in the use of those therapies by Americans over the last two decades, with chronic pain sufferers leading the way.   

Researchers at the National Institutes of Health looked at data from the 2002, 2012, and 2022 National Health Interview Survey (NHIS) to evaluate the use of seven alternative therapies: yoga, meditation, massage, chiropractic care, acupuncture, naturopathy, and guided imagery/progressive muscle relaxation.

Their findings, published in JAMA Network Open, show significant increases in the use of all seven therapies. The most widely used alternative therapy was meditation, which rose from 7.5% of respondents in 2002 to 17.3% in 2022.The largest increase in utilization was for yoga, which rose from 5% of respondents in 2002 to 15.8% in 2022.

Complimentary Health Approaches Used by U.S. Adults

NATIONAL INSTITUTES OF HEALTH

By 2022, over a third of respondents (36.7%) reported using at least one complimentary health approach (CHA), up from 19.2% in 2002. Nearly half said they used a CHA for pain management.

The CHAs most widely used for pain in 2022 were chiropractic care (85.7%) and acupuncture (72.8%). Researchers think that expanded insurance coverage for those treatments may have contributed to their growing use. Significant reductions in opioid prescribing over the last decade may have also driven people to try other treatments.  

Complimentary Health Approaches Used for Pain

NATIONAL INSTITUTES OF HEALTH

“Between 2002 and 2022, US adults increasingly used CHAs, including for pain management. This shift in utilization coincides with increased pain prevalence nationally and may be attributable to several factors, including randomized clinical trials suggesting that some CHAs provide low to moderate levels of pain management, incorporation of CHAs into best practice pain management guidelines, and the need to mitigate unnecessary use of potentially harmful opioids through use of nonopioid interventions,” wrote lead author Richard Nahin, PhD, lead epidemiologist at the National Center for Complementary and Integrative Health.

As with many of these data mining studies, the NIH researchers did not document what kind of pain conditions the respondents had, how often they used an alternative therapy, or even whether the treatment worked.  

According to one estimate, 55 million U.S. adults spent $28.3 billion on CHAs in 2012, about 9% of total out-of-pocket health care expenses that year.

Ketamine Therapy a ‘Wild West’ for Patients

By Dawn Megli, KFF Health News

In late 2022, Sarah Gutilla’s treatment-resistant depression had grown so severe, she was actively contemplating suicide. Raised in foster care, the 34-year-old’s childhood was marked by physical violence, sexual abuse, and drug use, leaving her with life-threatening mental scars.

Out of desperation, her husband scraped together $600 for the first of six rounds of intravenous ketamine therapy at Ketamine Clinics Los Angeles, which administers the generic anesthetic for off-label uses such as treating depression or chronic pain. When Gutilla got into an Uber for the 75-mile drive to Los Angeles, it was the first time she had left her home in Llano, California, in two years. The results, she said, were instant.

“The amount of relief I felt after the first treatment was what I think ‘normal’ is supposed to feel like,” she said. “I’ve never felt so OK, and so at peace.”

For-profit ketamine clinics have proliferated over the past few years, offering infusions for a wide array of mental health issues, including obsessive-compulsive disorder, depression, and anxiety. Although the off-label use of ketamine hydrochloride, a Schedule III drug approved by the FDA as an anesthetic in 1970, was considered radical just a decade ago, now between 500 and 750 ketamine clinics have cropped up across the nation.

Market researcher Grand View Research pegged industry revenues at $3.1 billion in 2022, and projects them to more than double to $6.9 billion by 2030. Most insurance doesn’t cover ketamine for mental health, so patients must pay out-of-pocket.

While it’s legal for doctors to prescribe ketamine, the FDA hasn’t approved it for pain or mental health treatment, which means that individual practitioners must develop their own treatment protocols. The result is wide variability among providers, with some favoring gradual, low-dosage treatments while others advocate larger amounts that can induce hallucinations, as the drug is psychedelic at the right doses.

“Ketamine is the wild West,” said Dustin Robinson, the managing principal of Iter Investments, a venture capital firm specializing in hallucinogenic drug treatments.

Ketamine practitioners stress that the drug’s emergence as a mental health treatment is driven by a desperate need. Depression is the leading cause of disability in the United States for individuals ages 15-44, according to the National Institute of Mental Health, and around 25% of adults experience a diagnosable mental disorder in any given year.

Meanwhile, many insurance plans cover mental health services at lower rates than physical health care, despite laws requiring parity. Thus many patients with disorders receive little or no care early on and are desperate by the time they visit a ketamine clinic, said Steven Siegel, chair of psychiatry and the behavioral sciences at the University of Southern California’s Keck School of Medicine.

But the revelation that “Friends” star Matthew Perry died in part from a large dose of ketamine, along with billionaire Elon Musk’s open use of the drug, has piqued fresh scrutiny of ketamine and its regulatory environment, or lack thereof.

Commercial ketamine clinics often offer same-day appointments, in which patients can pay out-of-pocket for a drug that renders immediate results. The ketamine is administered intravenously, and patients are often given blankets, headphones, and an eye mask to heighten the dissociative feeling of not being in one’s body. A typical dose of ketamine to treat depression, which is 10 times lower than the dosage used in anesthesia, costs clinics about $1, but clinics charge $600-$1,000 per treatment.

Ketamine is still shadowed by its reputation as the party drug known as “Special K”; Siegel’s first grant from the National Institutes of Health was to study ketamine as a drug of abuse. It has the potential to send users down a “K hole,” otherwise known as a bad trip, and can induce psychosis. Research in animals and recreational users has shown chronic use of the drug impairs both short- and long-term cognition.

Perry’s death in October raised alarms when the initial toxicology screening attributed his death to the acute effects of ketamine. A December report revealed Perry received infusion therapy a week before his death but that the fatal blow was a high dose of the substance taken with an opioid and a sedative on the day of his death — indicating that medical ketamine was not to blame.

A Variety of Protocols

Sam Mandel co-founded Ketamine Clinics Los Angeles in 2014 with his father, Steven Mandel, an anesthesiologist with a background in clinical psychology, and Sam said the clinic has established its own protocol. That includes monitoring a patient’s vital signs during treatment and keeping psychiatrists and other mental health practitioners on standby to ensure safety. Initial treatment starts with a low dose and increases as needed.

While many clinics follow the Mandels’ graduated approach, the dosing protocol at MY Self Wellness, a ketamine clinic in Bonita Springs, Florida, is geared toward triggering a psychedelic episode.

Christina Thomas, president of MY Self Wellness, said she developed her clinic’s procedures against a list of “what not to do” based on the bad experiences people have reported at other clinics.

The field isn’t entirely unregulated: State medical and nursing boards oversee physicians and nurses, while the FDA and Drug Enforcement Administration regulate ketamine. But most anesthesiologists don’t have a background in mental health, while psychiatrists don’t know much about anesthesia, Sam Mandel noted. He said a collaborative, multidisciplinary approach is needed to develop standards across the field, particularly because ketamine can affect vital signs such as blood pressure and respiration.

The protocols governing Spravato, an FDA-approved medication based on a close chemical cousin of ketamine called esketamine, are illustrative. Because it has the potential for serious side effects, it falls under the FDA’s Risk Evaluation and Mitigation Strategies program, which puts extra requirements in place, said Robinson. Spravato’s REMS requires two hours of monitoring after each dose and prohibits patients from driving on treatment days.

Generic ketamine, by contrast, has no REMS requirements. And because it is generic and cheap, drugmakers have little financial incentive to undertake the costly clinical trials that would be required for FDA approval.

That leaves it to the patient to assess ketamine providers. Clinics dedicated to intravenous infusions, rather than offering the treatment as an add-on, may be more familiar with the nuances of administering the drug. Ideally, practitioners should have mental health and anesthesia expertise, or have multiple specialties under one roof, and clinics should be equipped with hospital-grade monitoring equipment, Mandel said.

Siegel, who has researched ketamine since 2003, said the drug is especially useful as an emergency intervention, abating suicidal thoughts for long enough to give traditional treatments, like talk therapy and SSRI antidepressants, time to take effect. “The solutions that we have and have had up until now have failed us,” Mandel said.

The drug is now popular enough as a mental health treatment that the name of Mandel’s clinic is a daily sight for thousands of Angelenos as it appears on 26 Adopt-A-Highway signs along the 405 and 10 freeways.

And the psychedelic renaissance in mental health is accelerating. A drug containing MDMA, known as ecstasy or molly, is expected to receive FDA approval in 2024. A drug with psilocybin, the active ingredient in “magic mushrooms,” could launch as early as 2027, the same year a stroke medicine with the active ingredient of DMT, a hallucinogen, is expected to debut.

Robinson said many ketamine clinics have opened in anticipation of the expanded psychedelic market. Since these new drugs will likely be covered by insurance, Robinson advises clinics to offer FDA-approved treatments such as Spravato so they’ll have the proper insurance infrastructure and staff in place.

For now, Sarah Gutilla will pay out-of-pocket for ketamine treatments. One year after her first round of infusions, she and her husband are saving for her second. In the meantime, she spends her days on her ranch in Llano where she rescues dogs and horses, and relies on telehealth therapy and psychiatric medications.

While the infusions aren’t “a magic fix,” they are a tool to help her move in the right direction.

“There used to be no light at the end of the tunnel,” she said. “Ketamine literally saved my life.”

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

Experimental Non-Opioid Drug Effective in Treating Acute Pain

By Pat Anson, PNN Editor

An experimental non-opioid analgesic was effective in treating post-operative pain in two Phase 3 clinical trials, setting the stage for a New Drug Application to the FDA by Vertex Pharmaceuticals later this year.

The drug – called VX-548 – was given orally to patients with moderate-to-severe pain in the first 48 hours after an abdominoplasty or bunionectomy, two minimally invasive surgeries. VX-548 was more effective in reducing pain than the placebo, but it was not more effective than a combination of the opioid hydrocodone and acetaminophen, more commonly known as Vicodin.

In a third Phase 3 study, VX-548 was effective for up to 14 days across a broad range of surgical and non-surgical acute pain conditions. Over 80% of patients in that study rated VX-548 as good, very good, or excellent in treating pain.

“We are very pleased with the results from the VX-548 pivotal program, which demonstrate a compelling and consistent combination of efficacy and safety across multiple acute pain conditions and settings. The VX-548 benefit-risk profile ideally positions it to potentially fill the gap between medicines with good tolerability but limited efficacy and opioid medicines with therapeutic efficacy but known risks, including addictive potential,” Reshma Kewalramani, MD, CEO and President of Vertex, said in a press release.

“With FDA Breakthrough and Fast Track Designations in hand, we are working with urgency to file the New Drug Application for VX-548 and bring this non-opioid medicine to the millions of patients who suffer from acute pain each year in the U.S.”

VX-548 was generally safe and well tolerated in all three Phase 3 studies. Most of the adverse events reported by patients were mild to moderate, such as nausea and constipation.

Unlike opioids, VX-548 blocks pain in the peripheral nervous system, rather than the brain. That means it won’t have euphoric effects or be addictive. If approved for use by the FDA, experts say it would give patients and providers a much-needed alternative to opioids.

“As a physician treating patients suffering from pain for many years, I know firsthand the critical need for new, efficacious and safe treatment options,” said Jessica Oswald, MD, a Vertex consultant and Associate Physician in Emergency Medicine and Pain Medicine at University of California San Diego.

“The Phase 3 safety and efficacy across the three studies are impressive and demonstrate VX-548’s potential to change the paradigm of pain management. I look forward to the potential of having a new class of acute pain medicine — the first in more than two decades — to use as an alternative to opioids to help the millions of people impacted by acute pain.”

The risk of a surgery patient misusing opioids or becoming addicted is actually quite low – less than one percent. One recent study even found that restricting the use of opioids during surgery leads to more post-operative pain.

Vertex hopes to have VX-548 approved for a wide variety of pain conditions, not just post-operative pain.  Last month, the company released positive results for the drug in reducing pain from diabetic peripheral neuropathy.

Vertex also recently won approval from the FDA for its CRISPR gene cell therapy for sickle cell disease, which potentially offers a cure for the painful blood disorder.

Study Finds Low-Dose Naltrexone Works No Better than Placebo

By Pat Anson, PNN Editor

In recent years, low-dose naltrexone (LDN) has grown in popularity as a treatment for fibromyalgia and other chronic pain conditions. Although naltrexone is only FDA-approved for the treatment of substance use disorders, a growing number of patients and providers say low doses of naltrexone prescribed off-label can be effective in relieving pain.

A new study by Danish researchers is casting doubt on the some of those claims, finding that LDN works no better than a placebo in reducing pain for women with fibromyalgia. In their double-blind, placebo-controlled study, 99 adult women with fibromyalgia were randomly assigned to receive either an LDN pill or an identical-looking placebo daily for 12 weeks.

The study findings, recently published The Lancet Rheumatology, found a minor improvement in pain intensity for the LDN group, with a similar pain reduction in the placebo group. There were no serious adverse events in either group.

“This study did not show that treatment with low-dose naltrexone was superior to placebo in relieving pain. Our results indicate that low-dose naltrexone might improve memory problems associated with fibromyalgia, and we suggest that future trials investigate this further,” wrote lead author Karin Due Bruun, MD, a researcher in the Pain Center at Odense University Hospital in Denmark.

The Danish study is notable, because placebo-controlled, double-blind studies are considered the gold standard in medical research. Until now, much of the evidence about LDN has been anecdotal or low quality.

In a 2020 review of nearly 800 LDN studies, another research team could find only eight that were high quality enough to meet their criteria for evaluation. Nevertheless, they found that LDN “provides an alternative in medical management of chronic pain disorders.”

A 2019 review by British researchers also found that LDN is safe to use, but recommended that more clinical studies be conducted.

How naltrexone works is not exactly clear. LDN supporters believe the drug modulates the immune system, reduces inflammation and stimulates the production of endorphins, the body's natural painkiller.

In 50mg doses, naltrexone blocks opioid receptors in the brain and decreases the desire to take opiates or alcohol. But in smaller doses of 5mg or less, patients have found LDN to be an effective pain reliever. PNN columnists have shared their positive experiences using LDN to treat everything from interstitial cystitis to Ehlers-Danlos syndrome to fibromyalgia.  

A woman with fibromyalgia tried all sorts of FDA-approved medications to relieve her leg pain, brain fog and depression. None worked, until she tried LDN.   

“After about seven days, my pain lessened,” said Janice Hollander. “[LDN] has completely changed my life. I don’t know that I would be here today if it wasn’t for it. I don’t think I could go for another year in the misery I was in.” 

Naltrexone does cause minor side effects, such as nausea and dizziness, and because it is an opioid antagonist it should not be taken with opioid medication.

Patients interested in trying LDN often encounter doctors who won’t prescribe it off-label. The LDN Research Trust includes a list of LDN-friendly doctors and pharmacies on its website.

Older Americans Feel Trapped in Medicare Advantage Plans

By Sarah Jane Tribble, KFF Health News  

In 2016, Richard Timmins went to a free informational seminar to learn more about Medicare coverage.

“I listened to the insurance agent and, basically, he really promoted Medicare Advantage,” Timmins said. The agent described less expensive and broader coverage offered by the plans, which are funded largely by the government but administered by private insurance companies.

For Timmins, who is now 76, it made economic sense then to sign up. And his decision was great, for a while.

Then, three years ago, he noticed a lesion on his right earlobe.

“I have a family history of melanoma. And so, I was kind of tuned in to that and thinking about that,” Timmins said of the growth, which doctors later diagnosed as malignant melanoma. “It started to grow and started to become rather painful.”

Timmins, though, discovered that his enrollment in a Premera Blue Cross Medicare Advantage plan would mean a limited network of doctors and the potential need for preapproval, or prior authorization, from the insurer before getting care. The experience, he said, made getting care more difficult, and now he wants to switch back to traditional, government-administered Medicare.

But he can’t. And he’s not alone.

RICHARD TIMMINS

“I have very little control over my actual medical care,” he said, adding that he now advises friends not to sign up for the private plans. “I think that people are not understanding what Medicare Advantage is all about.”

Low Premiums and Extra Benefits

Enrollment in Medicare Advantage plans has grown substantially in the past few decades, enticing more than half of all eligible people, primarily those 65 or older, with low premium costs and perks like dental and vision insurance. And as the private plans’ share of the Medicare patient pie has ballooned to 30.8 million people, so too have concerns about the insurers’ aggressive sales tactics and misleading coverage claims.

Enrollees, like Timmins, who sign on when they are healthy can find themselves trapped as they grow older and sicker.

“It’s one of those things that people might like them on the front end because of their low to zero premiums and if they are getting a couple of these extra benefits — the vision, dental, that kind of thing,” said Christine Huberty, a lead benefit specialist supervising attorney for the Greater Wisconsin Agency on Aging Resources.

“But it’s when they actually need to use it for these bigger issues,” Huberty said, “that’s when people realize, ‘Oh no, this isn’t going to help me at all.’”

Medicare pays private insurers a fixed amount per Medicare Advantage enrollee and in many cases also pays out bonuses, which the insurers can use to provide supplemental benefits. Huberty said those extra benefits work as an incentive to “get people to join the plan” but that the plans then “restrict the access to so many services and coverage for the bigger stuff.”

Switching Plans

David Meyers, assistant professor of health services, policy, and practice at the Brown University School of Public Health, analyzed a decade of Medicare Advantage enrollment and found that about 50% of beneficiaries — rural and urban — left their contract by the end of five years. Most of those enrollees switched to another Medicare Advantage plan rather than traditional Medicare.

In the study, Meyers and his co-authors muse that switching plans could be a positive sign of a free marketplace but that it could also signal “unmeasured discontent” with Medicare Advantage.

“The problem is that once you get into Medicare Advantage, if you have a couple of chronic conditions and you want to leave Medicare Advantage, even if Medicare Advantage isn’t meeting your needs, you might not have any ability to switch back to traditional Medicare,” Meyers said.

Traditional Medicare can be too expensive for beneficiaries switching back from Medicare Advantage, he said. In traditional Medicare, enrollees pay a monthly premium and, after reaching a deductible, in most cases are expected to pay 20% of the cost of each nonhospital service or item they use. And there is no limit on how much an enrollee may have to pay as part of that 20% coinsurance if they end up using a lot of care, Meyers said.

To limit what they spend out-of-pocket, traditional Medicare enrollees typically sign up for supplemental insurance, such as employer coverage or a private Medigap policy. If they are low-income, Medicaid may provide that supplemental coverage.

But, Meyers said, there’s a catch: While beneficiaries who enrolled first in traditional Medicare are guaranteed to qualify for a Medigap policy without pricing based on their medical history, Medigap insurers can deny coverage to beneficiaries transferring from Medicare Advantage plans or base their prices on medical underwriting.

Only four states — Connecticut, Maine, Massachusetts, and New York — prohibit insurers from denying a Medigap policy if the enrollee has preexisting conditions such as diabetes or heart disease.

Paul Ginsburg is a former commissioner on the Medicare Payment Advisory Commission, also known as MedPAC. It’s a legislative branch agency that advises Congress on the Medicare program. He said the inability of enrollees to easily switch between Medicare Advantage and traditional Medicare during open enrollment periods is “a real concern in our system; it shouldn’t be that way.”

The federal government offers specific enrollment periods every year for switching plans. During Medicare’s open enrollment period, from Oct. 15 to Dec. 7, enrollees can switch out of their private plans to traditional, government-administered Medicare.

Medicare Advantage enrollees can also switch plans or transfer to traditional Medicare during another open enrollment period, from Jan. 1 to March 31.

“There are a lot of people that say, ‘Hey, I’d love to come back, but I can’t get Medigap anymore, or I’ll have to just pay a lot more,’” said Ginsburg, who is now a professor of health policy at the University of Southern California.

Timmins is one of those people. The retired veterinarian lives in a rural community on Whidbey Island just north of Seattle. It’s a rugged, idyllic landscape and a popular place for second homes, hiking, and the arts. But it’s also a bit remote.

While it’s typically harder to find doctors in rural areas, Timmins said he believes his Premera Blue Cross plan made it more challenging to get care for a variety of reasons, including the difficulty of finding and getting in to see specialists.

Nearly half of Medicare Advantage plan directories contained inaccurate information on what providers were available, according to the most recent federal review. Beginning in 2024, new or expanding Medicare Advantage plans must demonstrate compliance with federal network expectations or their applications could be denied.

Amanda Lansford, a Premera Blue Cross spokesperson, declined to comment on Timmins’ case. She said the plan meets federal network adequacy requirements as well as travel time and distance standards “to ensure members are not experiencing undue burdens when seeking care.”

Traditional Medicare allows beneficiaries to go to nearly any doctor or hospital in the U.S., and in most cases enrollees do not need approval to get services.

Timmins, who recently finished immunotherapy, said he doesn’t think he would be approved for a Medigap policy, “because of my health issue.” And if he were to get into one, Timmins said, it would likely be too expensive. For now, Timmins said, he is staying with his Medicare Advantage plan.

“I’m getting older. More stuff is going to happen.”

There is also a chance, Timmins said, that his cancer could resurface: “I’m very aware of my mortality.”

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

New Physical Therapy Helps Older Adults with Chronic Low Back Pain

By Pat Anson, PNN Editor

Older adults suffering from chronic low back pain experienced faster pain relief after getting a new type of physical therapy focused on strengthening their hip muscles, according to a new study.

The study findings, recently reported in The Lancet Rheumatology, are notable given the limited research on back pain therapies for older adults.

“Unfortunately, the societal attitude is that older people don’t warrant the same level of care that younger people do when it comes to musculoskeletal problems,” lead author Gregory Hicks, PhD, Distinguished Professor of Health Sciences at the University of Delaware, said in a press release.

“When I started this work, there were a lot of naysayers. I’d tell them, ‘Read the literature — why are we excluding older adults from low back pain research?’ We all hope to get older. Why ignore a place in time where we all hope to end up?”

Hicks and his colleagues enrolled 184 people aged 60 or older who reported moderate low back pain, hip pain, and muscle weakness for at least 6 months. Patients were randomly assigned to a hip-focused physical therapy known as Manual Therapy and Strengthening the Hip (MASH) or a more traditional physical therapy for back pain that focused on the spine. Both groups received therapy for eight weeks at the University of Delaware, Duke University or the University of Pittsburgh.

Researchers found that participants who received the MASH therapy had more pain relief after eight weeks than those who had spine-focused therapy. They also showed more improvement in walking endurance and in their ability to rise from a seated position. However, after six months, both groups showed similar levels of improvement.

Previous research by Hicks, funded by the National Institutes of Health, has studied the impact of hip impairment, vitamin D deficiency, and trunk muscle composition in older patients with low back pain. He learned that there were distinct sub-groups of patients with back pain who had unique characteristics and treatment needs.

“It’s becoming quite clear, if you make the assumption that all low back pain is the same, you’re wrong,” said Hicks. “If you can identify sub-groups of low back pain patients with similar traits, you can develop matched treatments, which hopefully lead to better outcomes.”

Low back pain is the leading cause of disability worldwide. According to a recent Harris Poll, nearly 3 out of 10 U.S. adults currently suffer from chronic low back pain, surpassing the number of Americans who have arthritis, diabetes or heart disease. On average, the typical back pain sufferer has sought relief from at least three healthcare providers, with many treatments such as epidural steroid injections proving ineffective.   

Lax FDA Oversight of Medical Devices Exposed in Lawsuits

By Fred Schulte and Holly K. Hacker, KFF Health News  

Living with diabetes, Carlton “PeeWee” Gautney Jr. relied on a digital device about the size of a deck of playing cards to pump insulin into his bloodstream.

The pump, manufactured by device maker Medtronic, connected plastic tubing to an insulin reservoir, which Gautney set to release doses of the vital hormone over the course of the day. Gautney, a motorcycle enthusiast, worked as a dispatcher with the police department in Opp, Alabama.

The 59-year-old died suddenly on May 17, 2020, because — his family believes — the pump malfunctioned and delivered a fatal overdose of insulin.

“There’s a big hole left where he was,” said Gautney’s daughter, Carla Wiggins, who is suing the manufacturer. “A big part of me is missing.”

The wrongful-death lawsuit alleges the pump was “defective and unreasonably dangerous.” Medtronic has denied the pump caused Gautney’s death and filed a court motion for summary judgment, which is pending.

The pump Gautney depended on was among more than 400,000 Medtronic devices recalled, starting in November 2019, after the company said in a recall notice that damage to a retainer ring on the pump could “lead to an over or under delivery of insulin,” which could “be life threatening or may result in death.”

CARLA WIGGINS AND CARLTON GAUTNEY

As the recall played out, federal regulators discovered that Medtronic had delayed acting — and warning patients of possible hazards with the pumps — despite amassing tens of thousands of complaints about the rings, government records show.

Over the past year, KFF Health News has investigated medical device malfunctions including:

• Artificial knees manufactured by a Gainesville, Florida, company that remained on the market for more than 15 years despite packaging issues that the company said could have caused more than 140,000 of the implants to wear out prematurely.

• Metal hip implants that snapped in two inside patients who said in lawsuits that they required urgent surgery.

• Last-resort heart pumps that FDA records state may have caused or contributed to thousands of patient deaths.

• And even a dental device, used on patients without FDA review, that lawsuits alleged has caused catastrophic harm to teeth and jawbones. CBS News co-reported and aired TV stories about the hip and dental devices.

The investigation has found that most medical devices, including many implants, are now cleared for sale by the FDA without tests for safety or effectiveness. Instead, manufacturers must simply show they have “substantial equivalence” to a product already in the marketplace — an approval process some experts view as vastly overused and fraught with risks.

“Patients believe they are getting an implant that’s been proven safe,” said Joshua Sharlin, a former FDA official who now is a consultant and expert witness in drug and medical device regulation. “No, it hasn’t,” Sharlin said.

And once those devices reach the marketplace, the FDA struggles to track malfunctions, including deaths and injuries — while injured patients face legal barriers trying to hold manufacturers accountable for product defects.

In a statement to KFF Health News, the FDA said it “has a scientifically rigorous process to evaluate the safety and effectiveness of medical devices.”

‘Too Little, Too Late’

The FDA approved the MiniMed 670G insulin pump on Sept. 28, 2016, after its most stringent safety review, a little-used process known as premarket approval.

In a news release that day, Jeffrey Shuren, who directs the FDA’s Center for Devices and Radiological Health, lauded the device as a “first-of-its-kind technology” that would give patients “greater freedom to live their lives” and to monitor and dispense insulin as needed. The pump was tested on 123 patients in a clinical trial over several months with “no serious adverse events,” the release said. Shuren declined to be interviewed for this article.

The FDA’s enthusiasm didn’t last. In November 2019, Medtronic, citing the ring problem, launched an “urgent medical device recall” of the pumps, which it expanded in late 2021.

During an inspection at Medtronic’s plant in Northridge, California, FDA officials learned the company had logged more than 74,000 ring complaints between 2016 and the November 2019 recall.

More than 800 complaints weren’t investigated at all, according to the FDA, which sharply criticized the company in a December 2021 warning letter.

MiniMed 670G insulin pump (MEDTRONIC IMAGE)

Medtronic is facing more than 60 lawsuits filed by injured patients and their families and the company believes it may be hit with claims for damages from thousands more patients, the company disclosed in an August Securities and Exchange Commission filing.

Medtronic pumps that allegedly dispensed too much, or too little, insulin have been blamed for contributing to at least a dozen patient deaths, according to lawsuits filed since 2019. Some cases have been settled under confidential terms, while others are pending or have been dismissed. Medtronic has denied any responsibility in response to the lawsuits.

In one pending case, a Las Vegas man using the pump allegedly fell into an “insulin-induced coma” that led to his death in 2020. In another 2020 case, a 67-year-old New Jersey resident collapsed at her home, dying later the same day at a local hospital.

The recall notice Medtronic sent to a 43-year-old Missouri man’s home arrived a few days after police found him dead on his bedroom floor, his family alleged in a lawsuit filed in August. “Simply too little, too late,” the suit reads. The case is pending, and Medtronic has yet to file an answer in court.

Medtronic declined to answer written questions from KFF Health News about the pumps and court cases. In an emailed statement, the company said it replaced pump rings with new ones “redesigned to reduce the risk of damage” and “fulfilled all pump replacement requests at no cost to customers.”

In April, Medtronic announced that the FDA had lifted the warning letter a few days after it approved a new version of the MiniMed pump system.

Shortcut to Market

The 1976 federal law that mandated safety testing for high-risk medical devices also created a far easier — and less costly — pathway to the marketplace. This process, known as a 510(k) clearance, requires manufacturers to show a new device they plan to sell has “substantial equivalence” to one already on the market, even if the prior product has been recalled.

Critics have worried for years that the 510(k)-approval scenario is too industry-friendly to protect patients from harm.

In July 2011, an Institute of Medicine report concluded that 510(k) was “not intended to evaluate the safety and effectiveness of medical devices” and said “a move away from the 510(k) clearance process should occur as soon as reasonably possible.”

More than a decade later, that hasn’t happened, even amid mounting controversy over the clearance of hundreds of devices that employ artificial intelligence.

The FDA now clears about 3,000 low- to moderate-risk devices every year through 510(k) review, which costs the device maker a standard FDA fee of about $22,000. That compares with about 30 approvals a year through the stricter premarketing requirements, which cost nearly $500,000 per device, according to FDA data.

Diana Zuckerman, president of the National Center for Health Research, said even many doctors don’t realize devices cleared for sale typically have not undergone clinical trials to establish their safety.

“Doctors are shocked to learn this,” she said. “Patients aren’t going to know it when their doctors don’t.”

In response to written questions from KFF Health News, the FDA said it “continues to believe in the merits of the 510(k) program and will continue to work to identify program improvements that strengthen the safety and effectiveness of 510(k) cleared devices.”

The FDA keeps a tight lid on data showing which devices manufacturers choose to demonstrate substantial equivalence — what the agency refers to as “predicate” devices.

“We can’t get detailed data,” said Sandra Rothenberg, a researcher at the Rochester Institute of Technology. “It’s very hard for researchers to determine the basis on which substantial equivalence is being made and to analyze if there are problems.”

Rothenberg cited the history of “metal-on-metal” artificial hip implants, which under 510(k) spawned many new brands — along with a disastrous toll of patient injuries. The implants could release metal particles that damaged bone and led to premature removal and replacement, a painful operation. Just four of these hip devices have been the target of more than 25,000 lawsuits seeking damages, court records show.

In early 2016, the FDA issued an order requiring safety testing before approving new metal-on-metal hip devices.

Alarm Bells

Two former Medtronic sales executives in California argue in a whistleblower lawsuit that the 510(k) process can be abused. According to the whistleblowers, the FDA approved the Puritan Bennett 980, or PB 980, ventilator in 2014 based on the assertion it was substantially equivalent to the PB 840, an earlier mechanical ventilator long viewed as the workhorse of the industry.

Medtronic’s subsidiary company Covidien made its claim even though the device has completely different “guts” and operates using software and other “substantially different” mechanisms, according to the whistleblowers’ suit. In response, Medtronic said it “believes the allegations are without merit and has moved to dismiss the case.” The case is pending.

The whistleblowers argue the PB 980 ventilator was plagued by dangerous malfunctions for years before its recall in late 2021. One ventilator billowed smoke in an intensive care unit while the whistleblowers were told by one hospital that “the wheels for the ventilator cart may actually fall off the ventilator during transport,” according to the suit.

Batteries could die without warning, kicking off a scramble to keep patients alive; monitor screens froze up repeatedly or otherwise went on the blink; and, in several cases, alarm bells warning of a patient emergency rang continuously and could be quieted only by unplugging the unit from the wall socket and pulling out its batteries, according to the suit.

The December 2021 recall of the PB 980 cited a “manufacturing assembly error” that the company said may cause the ventilator to become “inoperable.”

Medtronic said in an email that the ventilator “has helped thousands of patients around the world,” including playing a “critical role in the global response to the COVID-19 pandemic.”

Late Warnings

The FDA operates a massive database, called MAUDE, to alert regulators and the public to emerging device dangers. The FDA requires manufacturers to advise the agency when they learn their device may have caused or contributed to a death or serious injury, or malfunctioned in a way that might recur and cause harm. These reports must be submitted within 30 days unless a special exemption is granted.

But FDA officials acknowledge that many serious adverse events go unreported — just how many is anybody’s guess.

Since 2010, the FDA has cited companies more than 5,000 times for not handling, reviewing, or investigating complaints properly, or for not reporting adverse events on time. For instance, the FDA cited an Ohio company that made electric beds and other devices more than 15 times for failing to properly scrutinize complaints or report adverse events, including the death of a patient who allegedly became trapped between a bedrail and mattress, agency records show.

In about 10% of reports, more than a year or two elapsed from when a death or serious injury occurred and when the FDA received the reports, a KFF Health News analysis found. That works out to nearly 60,000 delayed reports a year.

Experts and lawmakers say the FDA needs to find a way to detect safety problems quicker.

Sens. Chuck Grassley (R-Iowa) and Elizabeth Warren (D-Mass.) have tried for years to persuade the agency to add unique device identifiers to Medicare payment claim forms to help track products that fail. In an email statement to KFF Health News, Grassley called that a “commonsense step we can take up front to mitigate risk, improve certainty and save money later.”

The FDA said it is working to “strike the right balance between assuring safety and fostering device innovation and patient access.” Yet it noted: “Additional resources are required to establish a fully functioning active surveillance system for medical devices.”

For now, injured patients suing device companies often cite the volume of adverse event reports to MAUDE, or FDA citations for failing to report them, to bolster claims that the company knew about product malfunctions but failed to correct them.

In one case, a New York man is suing manufacturer Boston Scientific, claiming injuries from a device called the AMS 800 that is used to treat stress urinary incontinence.

Though Boston Scientific says on its website that 200,000 men have been treated successfully, the lawsuit argues complaints piled up in MAUDE year after year and no action was taken — by the company or by regulators.

The number of complaints filed soared from six in 2016 to 2,753 in 2019, according to the suit. By far, the largest category involved incontinence, the condition the device was supposed to fix, according to the suit. Boston Scientific did not respond to a request for comment. The company has filed a motion to dismiss the case, which is pending.

By the FDA’s own count, more than 57,000 of some 74,000 complaints Medtronic received about the MiniMed insulin pump’s retainer rings were reported to the agency. The FDA said the complaints “were part of the information that led to the compliance actions.” The agency said it “approved design and manufacturing changes to the retainer ring to correct this issue” and “has reviewed information confirming the effectiveness of the modification.”

“What is the threshold for the FDA to step in and do something?” said Mara Schwartz, who is a nurse, diabetes educator, and pump user. “How many deaths or adverse events does there have to be?”

In 2020, she sued Medtronic, alleging she suffered seizures when the pump mistakenly delivered an overdose of insulin. Medtronic denied her claims, and the case has since been settled under confidential terms.

Private Eyes

Some countries don’t trust the device industry to play such a key role in oversight.

Australia and about a dozen other nations maintain registries that measure the performance of medical devices against competitors, with an eye toward not paying for care for a substandard device.

That’s not likely to happen in the United States, where no device or drug manufacturer must demonstrate its new product is better than what’s already for sale.

Product liability lawsuits in the U.S. often cite troubling findings from overseas. For instance, registries in Australia and other countries pinpointed durability problems with the Optetrak knee implants manufactured by Florida device company Exactech years before a major recall. Exactech has declined comment.

The Australian surveillance network also detected deficiencies with the Medtronic PB 980 ventilator, prompting the country’s health authority to suspend its use for six months until Medtronic completed training for health care workers and took other steps to improve it, court records show. Medtronic told KFF Health News that it had “worked closely” with the Australian group to resolve the problems. “We take patient safety very seriously and have processes to identify quality issues and determine appropriate actions,” Medtronic said.

Registries have gained some traction in America. But so far, they typically have been controlled, and sometimes funded, by industry and medical specialty groups that share their findings only with doctors.

One private registry managed by the Society of Thoracic Surgeons, called Intermacs, tracks death and injury rates at 180 hospitals in the United States certified to implant a mechanical heart pump known as an LVAD. Some patients might find that information helpful, but it’s not available to them.

‘New and Exciting Features’

While the FDA clears thousands of devices for use based on the “substantial equivalence” premise, manufacturers often tout “new and exciting features” in their advertising and other marketing, said Alexander Everhart, a researcher at the Washington University School of Medicine in St. Louis.

These marketing campaigns have long been controversial, especially when they rely partly on wining and dining surgeons and other medical professionals to gain new business, or when surgeons have financial ties to manufacturers whose products they use. Orthopedic device makers have funneled billions of dollars to surgeons, including fees for consulting, doing medical research, or royalties for their role in fine-tuning surgical tools and techniques, even promoting the products to their peers.

Marketing campaigns directed at prospective patients may receive little scrutiny. The FDA has “limited resources to actively monitor the volume of direct-to-consumer advertising,” according to a Government Accountability Office report issued in September. From 2018 to 2022, the FDA took 255 enforcement actions involving advertising claims made for devices, according to the GAO report.

While manufacturers can advertise devices directly to patients, courts may not hold them accountable for communicating possible risks to patients.

Consider the case of Richard Greisberg, a retired electronics business owner in New Jersey. He sued Boston Scientific in 2019, years after having a Greenfield vena cava filter implanted. The device is intended to prevent blood clots that develop in the lower body from traveling into the lungs, which can be deadly.

Greisberg argued that the device had migrated in his body, causing pain and other symptoms and damage that took years to identify. Representing himself in court, he tried to argue that nobody had told him that could happen and that if they had done so he wouldn’t have agreed to the procedure.

He lost when the judge cited a legal doctrine called “learned intermediary.” The doctrine, which is recognized in many states, holds that manufacturers must warn only physicians, who are presumed to have the knowledge to understand a medical device’s risks and relay them to patients.

The court ruled that a 27-page manual the manufacturer sent to the physician who implanted it, which included details about possible risks, was adequate and tossed the case.

Greisberg, 81, felt sucker-punched. “They never gave me any warning about what could happen down the road,” he said in an interview. “I never had a chance to have my day in court.”

The family of PeeWee Gautney also faces challenges pursuing the insulin pump lawsuit.

Gautney died in a motel room in Destin, Florida, a day after riding his Harley-Davidson to the Panhandle beach town on a weekend jaunt. The MiniMed pump was still strapped to his body, according to a police report.

Medtronic had sent Gautney a form letter in late March 2020, less than two months before he died, advising him to make sure the ring was locking in place correctly. A week later, he wrote back, telling the company: “It’s fine right now,” court records show.

Wiggins, 33, his daughter, who is also a neonatal respiratory therapist, said she believes a crack in the retainer ring caused it to release too much insulin, which her dad may not have recognized.

“It should never be put on the patient to determine if there is a problem,” Wiggins said.

Medtronic has denied the pump failed and caused Gautney’s death. The FDA approved the device knowing patients faced the risk of it administering wrong doses, but believed the benefits outweighed these risks, Medtronic argued in a motion for summary judgment in September. The motion is pending.

Medtronic also cited a legal doctrine holding that Congress granted the FDA sole oversight authority over devices receiving premarket approval, which preempts any product defect claims brought under state laws. Manufacturers have drawn on the preemption defense to sidestep liability for patient injuries, and often win dismissal, though federal courts are split in applying the doctrine.

Wiggins hopes to beat those odds, arguing that the December 2021 FDA warning letter reveals that Medtronic violated safety and manufacturing standards.

Her lawyer, Scott Murphy, said that insulin pumps are “really wonderful” devices for people with diabetes when they work right. He argues that the FDA records confirm that Medtronic significantly downplayed its pump’s hazards.

“The risks get minimized and the benefits exaggerated,” he said.

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

Can Herbal Supplements Effectively Relieve Pain?

Drs. Nial Wheate and Joanna Harnett, University of Sydney

In an era where chronic pain affects millions worldwide, the search for effective and safe pain relief has never been greater.

PanaNatra is a line of herbal products from Haleon, the makers of Panadol. Haleon claims the three PanaNatra’s products, made from plant extracts, help manage and provide relief from mild joint aches, mild muscle pain, and mild pain affecting sleep.

They contain different combinations of four plants:

• Boswellia serrata (contained in the joint and muscle products)

• Curcuma longa (in the joint and muscle products)

• Piper nigrum (just in the joint product)

• Withania somnifera (just in the sleep product).

These products are “listed medicines” in Australia. This means the ingredients are considered broadly low risk, have been used in traditional medicine, and are manufactured to a high standard. But the manufacturer has not provided evidence to the government regulator that they work.

So can herbal ingredients effectively and safely relieve different types of pain? Let’s consider the evidence for the four main ingredients.

Boswellia serrata

Indian Frankincense (Boswellia serrata) has been described in traditional Indian Ayurveda texts since the 1st century AD. Key active compounds derived from the gum resin of the tree called boswellic acids are thought to have anti-inflammatory effects.

The Boswellia serrata dry concentrate extract (Rhuleave K) used in the Muscle Pain product contains 50 mg of the herb per tablet, whereas the Joint Pain product includes 33.3 mg as a different formulation (Apresflex).

Boswellia serrata

A review of various human clinical trials using a range of formulations of this herb supports its ability to reduce some types of pain and improve function in osteoarthritis. But a key finding of the study was that improvement only begins when Boswellia serrata is used continuously for four weeks and at a dose of at least 100–250 mg per day.

In a clinical trial, 100 mg daily of a Boswellia serrata gum-based product was found to reduce pain and improve physical functions for people with osteoarthritis.

Curcuma longa

Turmeric (Curcuma longa) has been used in Chinese and Indian medicine for at least 2,000 years. It contains a well-known chemical called curcumin, a natural compound used for its anti-inflammatory properties, especially for osteoarthritis.

Turmeric compounds such as curcumin are often combined with Boswellia serrata compounds to improve their anti-inflammatory effects to reduce pain.

Curcuma longa

A review of 16 different clinical trials found turmeric extracts were effective for knee osteoarthritis.

A similar conclusion was drawn from a review of 11 clinical trials which examined the use of curcuminoids (of which curcumin is one) for one to four months. It found curcuminoids had similar pain-relieving qualities as non-steroidal anti-inflammatory based drugs.

Piper nigrum

Black pepper (Piper nigrum) contains the chemical piperine, which has anti-inflammatory properties.

Piper nigrum is often added to curcumin products to improve the absorption of curcumin, as is the case with the PanaNatra Joint Pain product.

Piper nigrum

For musculoskeletal pain, a preliminary human trial that examined the effects of a 1,000 mg daily dose of Rhuleave K (the extract used in PanaNatra) found it was as effective as paracetamol.

But the study was not placebo-controlled and the dose of paracetamol given (1,000 mg per day) was below the recommended daily intake for pain relief. 

Withania somnifera

Withania somnifera (also called Ashwagandha) has been used in traditional Indian Ayurvedic medicine for thousands of years to reduce stress and ease inflammation.

One of the key chemicals appears to be withaferin A, which interferes with the inflammatory signalling pathway.

Withania somnifera

PanaNatra’s Pain and Sleep product contains 300 mg per tablet of a Withania somnifera extract called KSM66.

A human trial found a daily 600 mg dose of Withania somnifera extract improved sleep quality and helped in managing insomnia.

In a separate trial, Withania somnifera was found to improve sleep quality, again when administered at a dose of 600 mg per day.

Does Herbal Medicine Work?

Whether, and how well, a herbal medicine works is largely dependent on the formulation (how it’s made and the extract used) and the dose provided. The same herb used in one formulation may result in a different outcome than a different formulation containing the same herb.

It’s also important to note that effectiveness for one type of pain does not mean a product will work for other types of pain.

Overall, similar herb extracts to those that have been included in the PanaNatra products do have some evidence that they work for pain and sleep. Whether they work for you will depend on a number of factors including the effectiveness of the PanaNatra formulation, how much you take, and the extent of your pain.

Is It Safe?

PanaNatra needs to be used carefully by some patients.

Overall, there is insufficient human data to recommend any of these herbal ingredients in pregnancy or lactation. In fact there is some evidence that Withania somnifera may be unsafe to use in pregnancy, and other than the amounts commonly found in food, turmeric and its compounds are not considered safe to use in pregnancy either.

The herbs may also impact the effectiveness and safety of other medicines. For example, the blood levels of the cancer drug tamoxifen may be reduced when taken concurrently with turmeric supplements.

Withania somnifera has been associated with drowsiness and cases of liver toxicity.

Curcuma longa products, including formulations containing curcumin and piperine, have also been associated with liver toxicity. As such, Australia’s Therapeutic Goods Administration has proposed adding warning labels to any products that contain those ingredients. But this discussion is ongoing and a decision won’t be made until next year.

While there is a long history of traditional use of the herbs in the PanaNatra products, there is limited high-quality scientific evidence for the effectiveness and safety for these specific products.

Pregnant and breastfeeding women should not take these products, and you should not exceed the daily dose recommended by the manufacturer.

If you have an underlying health condition, or are taking other medication, before you try them, consult your doctor or pharmacist to check if these products are suitable for you.

Nial Wheate, PhD, is an Associate Professor at the University of Sydney’s School of Pharmacy. He is a Fellow of the Royal Australian Chemical Institute and a member of the Australasian Pharmaceutical Science Association.

Joanna Harnett, PhD, is a Senior Lecturer at University of Sydney’s Faculty of Medicine and Health Pharmacy School, where she teaches and conducts research in the field of traditional, complementary, and integrative medicine.

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

Herbal Pain Relief Tea Recalled for Having Undeclared Drugs

By Pat Anson, PNN Editor

“Alleviates Pain & Inflammation Within 10 Minutes”

“Drug-Free All Natural Herbal Pain Relief”

As the saying goes, if the ads sound too good to be true, they probably are. Especially the part about being “drug-free.”

An herbal tea being marketed as a pain reliever for arthritis, gout, fibromyalgia and migraine is being voluntarily recalled after the Food and Drug Administration found that it contained “undeclared drugs.”

WS Global, a New York-based distribution company, is recalling all packages of Himalayan Pain Relief Tea after being informed by the FDA that the tea contains diclofenac, a non-steroidal anti-inflammatory drug (NSAID) and dexamethasone, a corticosteroid.

The company said it had not received any reports of adverse events involving the tea, but urged consumers to “immediately consult their health care professional” if they consumed it.

In a news release, the FDA said diclofenac may raise the risk of cardiovascular events, such as a heart attack or stroke, and could interact with other medications.

Dexamethasone can suppress the adrenal gland, impair a person’s ability to fight infections, and cause high blood sugar, muscle injuries and psychiatric problems. It may also have serious side effects when combined with other medications.

Neither diclofenac or dexamethasone are mentioned on the tea’s product label or advertising. The company claims the tea was “formulated by a traditional comprehensive recipe from the Himalayan monks.”

Himalayan Pain Relief Tea was being sold online, primarily through Amazon.

This is not the first time that an herbal or dietary supplement sold by Amazon was recalled due to undeclared drugs, contamination or other health concerns. In recent months, recalls were also ordered for a male sexual enhancement product, a glucose supplement, apple sauce, and an anti-cavity mouthwash for kids. All were being sold on Amazon.  

In a recent warning letter to Amazon’s CEO about selling several brands of unapproved eye drops, the FDA said the company should take more responsibility for the products it sells.

“The violations cited in this letter are not intended to be an all-inclusive statement of past or present violations that may exist in connection with the products you distribute. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations,” said Jill Furman, Director of the FDA Office of Compliance, Center for Drug Evaluation and Research.

Amazon complied with that request by removing the eye drops from its online marketplace.

“Safety is a top priority at Amazon. We require all products offered in our store to comply with applicable laws and regulations,” the company said in a statement.

Amazon received a similar warning letter in 2022, for selling a “misbranded” dietary supplement for arthritis that was linked to liver toxicity and at least one death. That product also contained diclofenac and dexamethasone.

You can still find Himalayan Pain Relief Tea on Amazon, with a notation that it is “currently unavailable.”

“We don't know when or if this item will be back in stock,” Amazon cautions potential buyers.

Back Pain? Bum Knee? Be Prepared to Wait for Physical Therapy

By Mark Kreidler, KFF Health News

At no point along his three-year path to earning a degree in physical therapy has Matthew Lee worried about getting a job.

Being able to make a living off that degree? That’s a different question — and the answer is affecting the supply of physical therapists across the nation: The cost of getting trained is out of proportion to the pay.

“There’s definitely a shortage of PTs. The jobs are there,” said Lee, a student at California State University-Sacramento who is on track to receive his degree in May. “But you may be starting out at $80,000 while carrying up to $200,000 in student debt. It’s a lot to consider.”

As many patients seeking an appointment can attest, the nationwide shortage of PTs is real. According to survey data collected by the American Physical Therapy Association, the job vacancy rate for therapists in outpatient settings last year was 17%.

Wait times are generally long across the nation, as patients tell of waiting weeks or even months for appointments while dealing with ongoing pain or post-surgical rehab. But the crunch is particularly acute in rural areas and places with a high cost of living, like California, which has a lower ratio of therapists to residents — just 57 per 100,000, compared with the national ratio of 72 per 100,000, according to the association.

The reasons are multifold. The industry hasn’t recovered from the mass defection of physical therapists who fled as practices closed during the pandemic. In 2021 alone, more than 22,000 PTs — almost a tenth of the workforce — left their jobs, according to a report by the health data analytics firm Definitive Healthcare.

Growing Demand for PT

And just as baby boomers age into a period of heavy use of physical therapy, and covid-delayed procedures like knee and hip replacements are finally scheduled, the economics of physical therapy are shifting. Medicare, whose members make up a significant percentage of many PT practices’ clients, has cut reimbursement rates for four years straight, and the encroachment of private equity firms — with their bottom-line orientation — means many practices aren’t staffing adequately.

According to APTA, 10 companies, including publicly held and private equity-backed firms, now control 20% of the physical therapy market.

“What used to be small practices are often being bought up by larger corporate entities, and those corporate entities push productivity and become less satisfying places to work,” said James Gordon, chair of the Division of Biokinesiology and Physical Therapy at the University of Southern California.

There’s a shortage of physical therapists in all settings, including hospitals, clinics, and nursing homes, and it’s likely to continue for the foreseeable future, said Justin Moore, chief executive of the physical therapy association. “Not only do we have to catch up on those shortages, but there are great indicators of increasing demand for physical therapy,” he said.

The association is trying to reduce turnover among therapists, and is lobbying Congress to stop cutting Medicare reimbursement rates. The Centers for Medicare & Medicaid Services plans a 3.4% reduction for 2024 to a key metric that governs pay for physical therapy and other health care services. According to the association, that would bring the cuts to a total of 9% over four years.

Several universities, meanwhile, have ramped up their programs — some by offering virtual classes, a new approach for such a hands-on field — to boost the number of graduates in the coming years.

“But programs can’t just grow overnight,” said Sharon Gorman, interim chair of the physical therapy program at Oakland-based Samuel Merritt University, which focuses on training health care professionals. “Our doctoral accreditation process is very thorough. I have to prove I have the space, the equipment, the clinical sites, the faculty to show that I’m not just trying to take in more tuition dollars.”

Rising Cost of PT Education

All of this also comes at a time when the cost of obtaining a physical therapy doctorate, which typically takes three years of graduate work and is required to practice, is skyrocketing. Student debt has become a major issue, and salaries often aren’t enough to keep therapists in the field.

According to the APTA’s most recent published data, median annual wages range from $88,000 to $101,500. The association said wages either met or fell behind the rate of inflation between 2016 and 2021 in most regions.

A project underway at the University of Iowa aims to give PT students more transparency about tuition and other costs across programs. According to an association report from 2020, at least 80% of recent physical therapy graduates carried educational debt averaging roughly $142,000.

Gordon said USC, in Los Angeles’ urban core, has three PT clinics and 66 therapists on campus, several of whom graduated from the school’s program. “But even with that, it’s a challenge,” he said. “It’s not just hard to find people, but people don’t stay, and the most obvious reason is that they don’t get paid enough relative to the cost of living in this area.”

Fewer therapists plus growing demand equals long waits. When Susan Jones, a Davis, California, resident, experienced pain in her back and neck after slipping on a wet floor in early 2020, she went to her doctor and was referred for physical therapy. About two months later, she said, she finally got an appointment at an outpatient clinic.

“It was almost like the referral got lost. I was going back and forth, asking, ‘What’s going on?’” said Jones, 57. Once scheduled, her first appointment felt rushed, she said, with the therapist saying he could not identify an issue despite her ongoing pain. After one more session, Jones paid out-of-pocket to see a chiropractor. She said she’d be hesitant to try for a physical therapy referral in the future, in part because of the wait.

Universities and PT programs graduate about 12,000 therapists a year, Moore said, and representatives of several schools told KFF Health News they’re studying whether and how to expand. In 2018, USC added a hybrid model in which students learn mostly online, then travel to campus twice a semester for about a week at a time for hands-on instruction and practice.

That bumped USC’s capacity from 100 students a year to 150, and Gordon said many of the hybrid students’ professional skills are indistinguishable from those of students on campus full time.

Natalia Barajas received her PT doctorate from USC last year and was recently hired at a clinic in nearby Norwalk, with a salary of $95,000, a signing bonus, and the opportunity to earn more in incentives.

She’s also managing a lot of debt. Three years of tuition for the USC physical therapy program comes to more than $211,000, and Barajas said she owes $170,000 in student loans.

“If it were about money alone, I probably would have shifted to something else a while ago,” Barajas said. “I’m OK with my salary. I chose to do this. But it might not be the perfect situation for everybody.”

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

The Trauma-Pain Connection Explored at For Grace’s Women In Pain Conference

By Cynthia Toussaint, PNN Columnist

Four years ago, I was wheeled into my pain management doctor’s office, not to talk about Complex Regional Pain Syndrome, but rather my newest and most dire diagnosis: Triple Negative Breast Cancer (TNBC). I knew I didn’t have a good chance at survival, but didn’t know why I had the most rare and aggressive form of the disease.

I asked Dr. Richeimer why this cancer would appear now, as my oncologist and genetic counselor were baffled. Without pause, he answered, “Cynthia, you’ve been trying to fix your dysfunctional family your entire life. The toll that’s taken on your body is why you have TNBC.”     

Thus began my trauma-informed journey.

I was already aware and intrigued that many researchers were identifying trauma as the main driver for chronic pain. Despite this, I passed on having trauma release treatment because I’d heard it could be triggering. But now that I was fighting for my very existence, I was all in.

In the midst of full-dose chemotherapy, no less, I took to reading and researching everything I could get my hands on about childhood trauma and how it leads to adult on-set chronic illness. On the trauma release front, I jumped into talk therapy and EMDR (Eye Movement Desensitization and Reprocessing), complimenting those treatments with big doses of music, writing, meditation, inner child work and ancestral healing.

I also started focusing my “For Grace” work on the trauma-pain connection. This included interviewing a boatload of experts and survivors as well as collecting and spotlighting lived experiences, all culminating in Friday’s 11th Annual Women In Pain Conference – “The Trauma-Pain Connection: A Path to Recovery and Growth.”

Radene Marie Cook

You see, I now understand that my 40+ years of pain and chronic illness are the result of serious and sustained trauma, suffered primarily during my early development. In short, trauma is not a piece of my chronic pain puzzle. It’s the whole puzzle.

I want to share all that I’ve learned with women in pain, during a day that I hope will launch your own trauma-informed journey, one that I promise will bring you healing and growth.

To start you on your way, our five-hour online seminar, beginning at 10am PT on November 17, will be broken into three sessions led by world-class speakers, panelists and breakout leaders, all who have survived trauma and volunteered their time.

• Session One will examine what trauma is, how it can be passed down generationally, and how it’s a driver for chronic pain.

• Session Two will highlight trauma release and the myriad of effective techniques, methods and strategies used to achieve that end, both practitioner-led and solo.

• Session Three will celebrate what I call the silver-lining of trauma, Post-Traumatic Growth, a process that paves the way for recovery, deeper meaning, new-found strength, and helping others.            

Themed throughout the conference will be the beauty, struggle and resilience of the Native American people. Because I’ve read time and again that this community suffers greatly from generational trauma, the day will be infused with stunning music and photography, compliments of one of our main speakers, Dr. Noshene Ranjbar, a leader of indigenous studies at the University of Arizona. It touched my heart that two of her students put in hours to gift us these sacred elements.

Perhaps the most poignant part of our event will be the extraordinary gift of intensely personal video vignettes sprinkled in from people who’ve traveled the dimly-lit trauma-pain tunnel, found healing through release, and moved on to the light of growth. The courage of these generous souls is a triumph of the spirit.      

This conference was For Grace’s heaviest lift to date. Coming from a chronic pain background, I didn’t know anyone in trauma and it took several years to build a critical mass of relationships. Also, because this conference is the first of its kind, our planning committee had to build it from whole cloth. Perhaps most difficult and most satisfying, was getting people to talk publicly about their deepest, darkest experiences. I know the challenge well because when I recorded my story, I was brought to tears more than once.

It was worth the sweat and tears because we struck gold.

This is the most important topic For Grace has covered. I’m certain that if you do the work, it will be a catalyst for healing and renewed wholeness. Remembering, facing and addressing our past traumas is our best hope to overcome the scourge of chronic pain.

Don’t wait to get a deadly disease to learn, to explore, to discover trauma’s place in your life. You’re braver than you think - and when you use that courage, you’ll be on the path to finding the last piece to your pain puzzle.

You can watch the conference for free at this link.

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 19 co-morbidities for 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.”