Supplements Often Tainted by Hidden Drugs

By Pat Anson, PNN Editor

Hundreds of dietary supplements – including some marketed to relieve joint and muscle pain – are tainted with pharmaceutical drugs, according to a new study published in JAMA Network Open.  

Researchers with the California Department of Public Health looked at 746 supplements that the Food and Drug Administration found to be adulterated from 2007 to 2016. About half of the supplements remained on the market, even after the FDA found they contained potentially harmful drugs.

"The FDA didn't even bother to recall more than half of the potentially hazardous supplements," Pieter Cohen, MD, a Harvard Medical School professor told NPR. "How could it be that our premier public health agency spends the time and money to detect these hidden ingredients and then doesn't take the next obvious step, which is to ensure that they are removed from the marketplace?"

Over half of American adults take dietary supplements that contain minerals, vitamins, herbs, fish oil and other “natural” substances.  Most of the adulterated supplements were marketed for sexual enhancement, weight loss or muscle building.

Of the 14 supplements that were promoted as treatments for arthritis, muscle and joint pain, osteoporosis or other painful conditions, half contained diclofenac, a nonsteroidal anti-inflammatory drug (NSAID) and five contained dexamethasone, a steroid used to treat inflammation.

One supplement promoted as a treatment for arthritis – Pro ArthMax -- was found to contain four different NSAIDs, as well as a muscle relaxant and a non-narcotic pain reliever that was never approved for use in the United States. The manufacturer of Pro ArthMax voluntarily recalled the supplement in 2014 after being warned by the FDA.   

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Cohen chided the agency for relying on voluntary recalls to get tainted supplements off the market and accused the FDA of “dereliction of duty” in a JAMA commentary. He called on Congress to change the federal law that exempts the $35 billion dollar supplement industry from pre-market safety and clinical studies that are required for pharmaceutical drugs.   

“More than FDA action will be required to ensure that all adulterated supplements are effectively and swiftly removed from the market,” Cohen wrote. “The process that the FDA is required to follow to remove supplements from the marketplace (is) cumbersome and time-consuming; nevertheless, the agency’s failure to aggressively use all available tools to remove pharmaceutically adulterated supplements from commerce leaves consumers’ health at risk.”

Dietary supplements that are tainted with hidden drugs may interact with other medications and raise the risk of adverse events, particularly when consumers already may be using NSAID-containing products.  

A New Era for Genetic Medicine

By Barby Ingle, PNN Columnist

This past September, I attended several conferences for chronic pain awareness month. Most had the same speakers and the same topics, but a promising new development was discussed at one meeting: Genetic medicine as a treatment for painful diseases.

For those who are new to the concept of gene replacement therapy, this is a potential way to treat genetic diseases that would save time, pain, life and energy for anyone with a gene related health challenge.

New genetic therapies, such as gene editing and oligonucleotides, are already paving the way towards treating rare diseases. Gene therapy focuses on adding a corrected copy of a gene or directly altering a mutated gene, while oligonucleotides are synthetic molecules used to inactivate genes involved in the disease process.

I listened to leaders from patient advocacy and industry discuss the promise of these new approaches, including Bartholomew Tortella, MD, who is a leader in Global Medical Affairs at Pfizer and Pushkal Garg, MD, who is Chief Medical Officer at Alnylam Pharmaceuticals. It was interesting to me that pharmaceutical companies are on the cutting edge of gene therapies.

One of the things I learned is that genetic editing and remapping are “one and done” treatments. A gene fix can only be done once. No doubt it would be expensive, but if it works what is the price of 30 years of standard treatments to manage a condition vs. a one-time treatment that can reverse the actual underlying genetic issue?

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I have had Prometheus and Color gene testing, and know that I have some life challenges of my own built into my genes. But learning about the potential of gene therapy gave me reason for hope.

There are already genetic therapies that are approved by the FDA for blind patients. Other genetic treatments will be coming online soon. We have been making advances with mice in research studies, and translating that into human clinical trials has now begun.

Would you want to get involved in the early stages of genetic testing? Or would you rather wait until its safety and effectiveness is proven? We won’t make progress without patients who are willing to volunteer and have their genes edited first. This is something that is a little sci-fi and scary to comprehend. It takes a special person to go first in these types of situations, yet the scientists I spoke with say the trials are being closely monitored for safety and efficacy.

One major challenge is that viruses are often used in gene replacement therapy to introduce the proper genes into the body. If a patient has previously been exposed to the virus, the new gene will be attacked by the body’s immune system and the treatment won’t work. If the therapy works, the virus is now in their body and it will not be a future option as a delivery system if the gene mutation returns or is not fully corrected.

Finding that Goldilocks zone for each patient will continue to be a challenge.

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Barby Ingle lives with reflex sympathetic dystrophy (RSD), migralepsy and endometriosis. Barby is a chronic pain educator, patient advocate, and president of the International Pain Foundation. She is also a motivational speaker and best-selling author on pain topics. More information about Barby can be found at her website.  

The information in this column should not be considered as professional medical advice, diagnosis or treatment. It is for informational purposes only and represents the author’s opinions alone. It does not inherently express or reflect the views, opinions and/or positions of Pain News Network.

Many Alternative Therapies for Back Pain Not Covered

By Pat Anson, PNN Editor

A new study by the Johns Hopkins Bloomberg School of Public Health has confirmed what many back pain sufferers already know: Public and private health insurance plans often do not cover non-drug alternative pain therapies.

Bloomberg researchers looked at dozens of Medicaid, Medicare and commercial insurance coverage policies for chronic lower back pain and found that while most plans covered physical therapy and chiropractic care, there was little or no coverage for acupuncture, massage or counseling.

"This study reveals an important opportunity for insurers to broaden and standardize their coverage of non-drug pain treatments to encourage their use as safer alternatives to opioids," says senior author Caleb Alexander, MD, a professor of epidemiology at the Bloomberg School.  

Alexander and his colleagues examined 15 Medicaid, 15 Medicare Advantage and 15 major commercial insurer plans that were available in 16 states in 2017.

Most payers covered physical therapy (98%), occupational therapy (96%), and chiropractic care (89%), but coverage was inconsistent for many of the other therapies.

Acupuncture was covered by only five of the 45 insurance plans and only one plan covered therapeutic massage.

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Nine of the Medicaid plans covered steroid injections, but only three covered psychological counseling.

"We were perplexed by the absence of coverage language on psychological interventions," Alexander says. "It's hard to imagine that insurers wouldn't cover that."  

Even for physical therapy, a well-established method for relieving lower back pain, insurance coverage was inconsistent.

"Some plans covered two visits, some six, some 12; some allowed you to refer yourself for treatment, while others required referral by a doctor," Alexander says. "That variation indicates a lack of consensus among insurers regarding what model coverage should be, or a lack of willingness to pay for it.”  

The Bloomberg study is being published online in the journal JAMA Network Open.  It was funded by the U.S. Department of Health and Human Services, National Institutes of Health and the Centers for Disease Control and Prevention.  

Lower back pain is the world’s leading cause of disability, but there is surprisingly little consensus on the best way to treat it. A recent series of reviews by an international team of experts in The Lancet medical journal found that low back pain is usually treated with bad advice, inappropriate tests, risky surgeries and painkillers.

“The majority of cases of low back pain respond to simple physical and psychological therapies that keep people active and enable them to stay at work,” said lead author Rachelle Buchbinder, PhD, a professor at Monash University in Australia. “Often, however, it is more aggressive treatments of dubious benefit that are promoted and reimbursed.”

The authors recommend counseling, exercise and cognitive behavioral therapy as first-line treatments for short-term low back pain, followed by spinal manipulation, massage, acupuncture, meditation and yoga as second line treatments. They found limited evidence to support the use of opioids for low back pain, and epidural steroid injections and acetaminophen (paracetamol) are not recommended at all.

Does Coffee Reduce Your Pain?

By Steve Weakley

Saturday, September 29th is National Coffee Day, so drink up! A new study shows that caffeine can be an effective pain reliever.

Researchers at the University of Alabama at Birmingham (UAB) reported in the journal Psychopharmacology that regularly consuming caffeine can make a noticeable difference in your ability to withstand pain.  The study involved 62 healthy men and women, who shared with researchers their caffeine consumption from coffee, tea, soda, energy drinks and chocolate over seven days.

The group averaged 170 milligrams of caffeine a day, about the same as two cups of coffee.  Fifteen percent of the group consumed more than 400 milligrams a day and one participant drank the equivalent of 6.5 cups of coffee daily.

After a week, the volunteers were subjected to painful heat and pressure tests in a laboratory. Researchers discovered that people who regularly consumed caffeine significantly reduced their sensitivity to pain. The more caffeine they consumed, the lower their sensitivity.

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“Diet can actually be a useful intervention for decreasing pain sensitivity,” said lead author, Burel Goodin, PhD, an associate professor of psychology at UAB. “It’s not just caffeine. A study has shown, for example, that a plant-based diet can actually help increase pain tolerance.”

Researchers say caffeine reduces pain by blocking receptors in the brain called adenosines, which enhances the effect of dopamine chemicals associated with pain relief.  

Caffeine has been added to over-the-counter pain relievers like Excedrin for years, and has been shown to increase their effectiveness by as much as 40 percent.  South Korean researchers have also added caffeine to the opioid medication of patients with advanced cancer and found that it decreased their pain and improved alertness.

Other research has corroborated the effectiveness of caffeine alone as a pain reliever.  A University of Georgia study revealed that two cups of coffee can reduce post workout pain by nearly half.  And a study at the University of Pittsburgh found that a single 200mg tablet of caffeine was effective in treating muscle pain.

Excessive caffeine consumption can have serious side effects, but the Mayo Clinic says 400mg per day is a safe dosage (about 4 cups of coffee). A few cups could be a useful addition to your pain treatment regimen.

Are You Skinny Fat?

By Barby Ingle, PNN Columnist

I recently was visiting my primary care doctor for my wellness physical -- something I haven’t done in many years. This was a comprehensive exam that took a look at all of my physical symptoms, including body fat to bone density ratio.

I have heard since childhood that a bit of prevention can add years to your life. A healthy lifestyle is not something many of us are taught, but it is something we can start at any age and gain benefits from. Take heart disease, for example. It’s the number one killer in the United States and accounts for one in every four deaths. Many chronic pain patients have cardiovascular, balance, breathing and body fat challenges. Treating these health problems is difficult, so preventing them from starting is key.

When was your last wellness physical? Did you talk about prevention?

My medical records from a one-hour examination with a nurse and two hours with the doctor were 18 pages long. I was checked for routine things such as my vitals, medication use and past medical history. Risk factors were also discussed such as alcohol and smoking. I do neither and never plan to anyway.

My doctor devotes more time to each patient so that we can go beyond normal primary care practices. He and his staff perform a comprehensive advanced health screening and diagnostic tests that have been shown to help detect issues earlier. The results help give a clearer view of your overall health.

We went over a lot as I have been a patient of his for about 15 years now. He is my lead treatment provider and knows my case better than all of my other doctors.

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One of the most interesting things was him saying I look totally normal and healthy. Yes, that is called invisible illness. But after looking at all of my blood and diagnostic test results, he got deep into his analysis. He said I am “skinny fat.”

What is skinny fat you ask? It’s a totally unscientific term used to describe a person who appears to be a healthy weight, but actually has a high body fat to muscle ratio. For example, my arms are stronger and have more muscle mass than my legs.

My entire life I was eating poor. I was the one eating mac ‘n’ cheese, cookies, cake and soda. I was an athlete and had hypoglycemia until I was 29. Then I developed central pain syndrome (also known as full body Reflex Sympathetic Dystrophy) and went from being extremely active and working out daily to bedbound or in a wheelchair for almost 7 years. I have been limited in workouts and physical activities for the past 8 years, going in and out of remissive states.

It is important to remember that the scale doesn’t paint the whole picture as to how healthy you are. You can be obese and look totally healthy or have great muscle tone and thicker bones. Looks can be deceiving. Some studies suggest that up to 35 percent of people with obesity may be metabolically healthy.

The number on the scale doesn’t paint the whole picture of someone’s health. Being skinny fat is a prime example. In my case, I am metabolically obese, yet in a normal weight range. Although I am not diabetic or even pre-diabetic, my doctor said I still need to pay attention to being skinny fat and make changes. I need to get my fat levels down and my muscle level up.

Preventative measures like these need to be added to my lifestyle, despite having chronic pain. Not doing so can lead to health problems like insulin resistance, high blood pressure, high cholesterol and an increased risk for blood clotting. This study gives some great information on the risks of being skinny fat from a medical standpoint.

By the time I left my doctor’s office, I had a detailed action plan.

My plan is to get my muscle mass up and my fat mass down over the next 3 months. I don’t know if this is wishful thinking being chronically ill, but I am going to give it my best shot. The tips my doctor gave include moving more with cardio walks, stationary bike exercises, and lifting two-pound weights -- which should be enough to tone my muscles without triggering a pain flare. He also advised me to eat more protein and stop eating all of the processed food that filled my diet.

My doctor will redo the testing in 3 months and let me know what other changes I need to make or if this was enough.

When you see another patient who is super skinny, know that they may be struggling with their body composition as well, and they may actually not be as healthy as you are. I have struggled with being too low weight in the past.  Now I am in a normal range, yet too fat!

It seems like we all have something to work on. I wish that as a child I was taught these important preventative and life-prolonging lessons.

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Barby Ingle lives with reflex sympathetic dystrophy (RSD), migralepsy and endometriosis. Barby is a chronic pain educator, patient advocate, and president of the International Pain Foundation. She is also a motivational speaker and best-selling author on pain topics. More information about Barby can be found at her website. 

The information in this column should not be considered as professional medical advice, diagnosis or treatment. It is for informational purposes only and represents the author’s opinions alone. It does not inherently express or reflect the views, opinions and/or positions of Pain News Network.

The Abyss of Chronic Pain

By David Hanscom, MD, Guest Columnist

One afternoon, I was listening to a pain patient attempt to describe the depth of her suffering, and it hit me how dark and deep this hole of chronic pain can be.

I had a flashback to my own experience with pain. Not only did I not know how I ended up in that level of misery, I had no hope and wasn’t being given any answers. I kept descending deeper and deeper into darkness.

Words couldn’t come close to describing my physical and mental suffering, but the image that came to mind was a deep dark abyss. I will never forget what it was like to be there and trapped in the abyss for over 15 years.

One night, I was driving across a bridge when suddenly my heart began to pound.  I couldn’t breathe, began sweating and became light-headed. I thought I was going to die. It was the first of many panic attacks. And it became much worse. I sank into a deep depression.

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I honestly had no clue at the time that my anxiety and other symptoms were all linked together by sustained levels of stress hormones, such as adrenaline, cortisol and histamines.

I couldn’t sleep because of endless racing thoughts. My ears were ringing and my feet constantly burned. I began to get migraine headaches weekly. My scalp itched, and skin rashes would pop up all over my body and then disappear. I experienced intermittent crushing chest pain.

As unpleasant as these physical symptoms were, it wasn’t the worst part of the story.

I began a relentless search for answers. What was happening to me? My life went from being a hard-working young physician with a bright future to just trying to survive. As a spine surgeon in a large city, I had access to the best medical care and underwent all sorts of imaging and blood testing. No one could tell me what was going on. I became increasingly frustrated and moody.

After seven years of this, I lost my marriage. No marriage could have survived the obsessive energy I was using to try and escape from the abyss.

My anxiety progressed to a full-blown obsessive-compulsive disorder (OCD), which is characterized by repetitive and vivid intrusive thoughts. It was brutal. I had always thought that OCD was a joke, but it may be the worst mentally painful experience in human existence. I looked up the treatment and prognosis for it, and it was dismal.

My mind began to play tricks on me. I become an “epiphany addict.” I was sure I could find an answer if I looked hard enough. I read book after book, saw doctors, tried different medications, practiced meditation, and discussed my situation with anyone who would listen. That number grew smaller, as people got tired of listening to me and I became increasingly socially isolated.  

Every aspect of this experience was miserable but the loneliness I felt was the worst. Being alone, I had more time to think about my misery and became fearful that people didn’t want to be around me. I hadn’t realized how terrible being lonely could be.

I wanted to quit being a doctor, but my instincts told me to hang on. I still enjoyed performing complex spine surgery and running my practice. I liked my staff, colleagues and patients. In retrospect, that may have been the one thing that provided the structure to keep me going. My personal life had disintegrated.

As I write this column, I still feel woefully inadequate to find the words to characterize the intensity of my suffering. I was in this hole for over 15 years and crossed the line to end it all.

Learning How to Feel Good Again

Then in 2003, I picked up a book by Dr. David Burns, called Feeling Good: The New Mood Therapy.” It’s about self-directed cognitive behavioral therapy.  Burns was adamant from the beginning of the book that the key to recovery was to start writing. His format is a three-column technique where you write down your disruptive thoughts, categorize them into one of 10 “cognitive distortions,” and then write down more rational thoughts.

I began to write for hours and for the first time in 15 years felt a shift in my mood and thinking. Burns is right, the act of writing is important. There are now over 1,000 research papers documenting the effectiveness of this approach.  

Six months after I began this therapy, I connected (badly) with my deep-seated anger and was completely miserable for about 2 weeks. But as I emerged from this fog, I began to feel better. All of my physical symptoms eventually disappeared, including my headaches, burning in my feet, anxiety, and tinnitus.

It all goes back to the stress hormones. When you are trapped by anything, especially pain, your body is exposed to sustained levels of stress chemicals and each organ will react in its own specific way. Today, my symptoms remain at minimal levels unless they are triggered, and I have learned how to quickly return to feeling good.

There are many additional layers to the healing journey that are presented on my website. Each person will relate to the concepts in a different way, but the outcomes have been consistently good. There is a recent research paper that shows simply learning about the neuroscience of chronic pain can significantly reduce it.

I got incredibly lucky and feel fortunate to be able to pass along these healing concepts to my patients. It has been an unexpected and rewarding phase of my career.

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

In his book Back in ControlHanscom shares the latest developments in neuroscience research and his own personal history with pain.

The information in this column should not be considered as professional medical advice, diagnosis or treatment. It is for informational purposes only and represents the author’s opinions alone. It does not inherently express or reflect the views, opinions and/or positions of Pain News Network.

Can Sugar Pills Relieve Chronic Pain?

By Pat Anson, PNN Editor

“Sugar pills relieve pain for chronic pain patients”

That is the actual headline in a news release issued this week by the Feinberg School of Medicine at Northwestern University. If you’re a pain sufferer and that doesn’t make you laugh or get your blood boiling – then the rest of this article probably will.

So be forewarned.

In an age when many chronic pain patients are being urged to try yoga, meditation, acupuncture and plain old aspirin, Northwestern researchers have concluded that many could find pain relief in a sugar pill.

That conclusion is based on a lengthy but small study of 63 patients with chronic back pain.  Twenty patients were given no treatment, while the rest were given a placebo – a sugar pill that they were told was pain medication. No one was given an actual painkiller.

Over the course of 8 weeks, participants tracked their pain on a smartphone app, MRI brain images were taken, and psychological profiles of each patient were made.

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The study, published in the journal Nature Communications, found that about half the patients who took the placebo had a 30 percent reduction in pain, a level considered just as effective as a real painkiller.

Researchers said patients who responded to the sugar pills had a similar brain anatomy and psychological traits. The right side of their emotional brain was larger than the left, and they had a larger sensory area than people who did not respond to the placebo. The placebo responders also were more emotionally self-aware, sensitive to painful situations and mindful of their environment.

“This is the first brain imaging RCT (randomized controlled trial) specifically designed to study chronic pain patients receiving placebo pills compared to a no treatment arm,” said senior study author A. Vania Apkarian, PhD, a professor of physiology at Northwestern University Feinberg School of Medicine.  

“Daily pain ratings from a smart phone revealed that patients receiving placebo pills showed stronger pain reduction and a higher response rate compared to patients in the no treatment arm, indicating that placebo pills successfully induced analgesia that could not be explained by the natural history of the patient or the mere exposure to the study.”

Doctors ‘Should Seriously Consider’ Placebos

Although his study is small and needs to be replicated, Apkarian thinks doctors should put his findings to work.

"Clinicians who are treating chronic pain patients should seriously consider that some will get as good a response to a sugar pill as any other drug," he said. "They should use it and see the outcome. This opens up a whole new field."

Giving pain patients sugar pills would not only save healthcare costs, Apkarian says they would eliminate the risk of addiction and other side-effects from pharmaceutical drugs.

"It's much better to give someone a non-active drug rather than an active drug and get the same result," Apkarian said. "Most pharmacological treatments have long-term adverse effects or addictive properties. Placebo becomes as good an option for treatment as any drug we have on the market."

The medical community has long known about the potency of the placebo effect and put it to use. Doctors as far back as the late 18th century used placebo treatments “more to please than benefit the patient.”

Today, the gold standard of clinical trials is a “placebo-controlled study” in which some participants are given sugar pills and sham treatments. The medication or therapy being studied has to be found more effective than the placebo for the study to be considered a success.

Time magazine recently published a cover story on placebos, sharing the stories of real patients who find relief in placebo pills even though they know they’re fake.

You don’t need to enroll in a clinical study to take placebos. You can buy a bottle of Zeebo’s “honest placebo pills” for $14.95 on Amazon. Some of the reviews for Zeebo are hilarious.

“I have not bought this product, but just reading about it brightened my day. And the comfort of knowing that if I ever needed a good placebo, its right here available with free shipping and two day delivery. I feel better already!” said one reviewer.

“The pills do every thing promised, which is nothing,” wrote another reviewer. “I purchased them in the forlorn hope that they would fool my demented wife that they helped to relieve her chronic pain. I didn't expect much going in and I wasn't disappointed.”

Many Invasive Surgeries No Better Than Placebo

By Pat Anson, PNN Editor

In an age when doctors are urged not to prescribe opioids, many patients are being told to have surgery or other invasive procedures to treat their chronic pain.

But a systematic review of 25 clinical trials found little evidence that invasive surgeries are more effective than placebo or sham procedures in reducing low back and knee pain. The study was published in the journal Pain Medicine.

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"Our findings raise several questions for clinicians, researchers, and policy-makers. First, can we justify widespread use of these procedures without rigorous testing?" said lead author Wayne Jonas, MD, a Professor of Family Medicine at Georgetown University School of Medicine.

“Given their high cost and safety concerns, more rigorous studies are required before invasive procedures are routinely used for patients with chronic pain.”

The invasive procedures that were analyzed include arthroscopic, endoscopic and laparoscopic surgeries, as well as radiofrequency ablations, laser treatments and other interventions.

In each study, researchers also performed sham or placebo procedures on a control group where they faked the invasive procedure. Patients did not know which intervention (real or sham) they received. Researchers then compared the patients’ pain intensity, disability, health-related quality of life, use of medication, adverse events, and other factors.

They found that reduction in disability did not differ between the two groups three months after the procedures or at six months. Seven of the studies on low back pain and three on knee osteoarthritis showed no difference in pain intensity at six months compared with the sham procedures.

“There is little evidence for the specific efficacy beyond sham for invasive procedures in chronic pain. A moderate amount of evidence does not support the use of invasive procedures as compared with sham procedures for patients with chronic back or knee pain,” said Jonas.

Invasive treatments are being increasingly used as an alternative to opioids. Americans spent an estimated $45 billion on surgery for chronic low back pain and $41 billion on arthroplasty for knee pain in 2014.

Several previous studies have also questioned the value of arthroplasty. Over 850,000 arthroscopic surgeries are performed every year to relieve knee pain in the UK and the United States. But a 2015 study published in the BMJ questioned the evidence behind the surgery and said it provides only “small inconsequential benefit.”

FDA Wants More Medical Devices to Treat Pain

By Pat Anson, Editor

The deadline is fast approaching for companies to enter the Food and Drug Administration’s medical device challenge, a contest of sorts aimed at stimulating the development of new technologies to treat pain and prevent opioid abuse.

The FDA announced the innovation program in May and the deadline for applications is September 30.  Medical devices in any state of development – including those already on the market – are eligible for submission.

“Medical devices, including digital health devices like mobile medical apps, have the potential to play a unique and important role in tackling the opioid crisis,” FDA Commissioner Scott Gottlieb, MD, said in a statement. “Better medical devices that can effectively address local pain syndromes can, in some cases, supplant the use of systemic opioids. This can help reduce overall use of opioids.”

Devices that are found to innovative will receive a “breakthrough device” designation from the FDA – similar to the “fast track” designation that the agency gives to promising pharmaceutical drugs. With fewer regulatory hurdles, companies can bring their products to the market sooner.

“I think its great. It’s exactly the kind of thing that’s needed,” said Shai Gozani, MD, President and CEO of NeuroMetrix, the maker of Quell. “It’s a little unclear what exactly they’ll offer to the winners. It looks like they’ll give you intensive help for a period of time to climb the regulatory pathway."

In recent years, the FDA has granted or approved over 200 devices related to the treatment and management of pain. One of them was Quell – a nerve stimulation device worn just below the knee – that relieves pain without drugs in patients suffering from arthritis, neuropathy, fibromyalgia and other chronic conditions. Since its release in 2015, over 150,000 Quell devices have been shipped.

This week NeuroMetrix released Quell 2.0 – an updated version that is half the size and weight. Customers wanted a smaller device to make it easier and more comfortable to wear throughout the day and while sleeping.

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“The feedback we got from customers over the past three years is that the single most valuable way to improve the product was to make it smaller,” said Gozani.  “Quell 2.0 is half the size, without any sacrifice in the electric stimulation characteristics. In fact, we increased the power by 20 percent, which allows us to stretch the range of patients that can be treated even further.”    

Gozani told PNN there is no single disorder or medical condition that Quell works best on -– it depends more on the individual, who may live with a variety of different conditions.

“Most people who use our product typically have five sites of pain and three or four medical conditions. It’s not like you can say that person has diabetes or that person has lower back pain or knee osteoarthritis. It all overlaps,” he said. “Surprisingly, we’ve seen that it works better in older adults than in younger.”

PNN columnist Jennifer Kilgore, who lives with chronic back pain, has used Quell every day for three years. She appears below in this promotional video for Quell.

A major difference between Quell 2.0 and the older “classic” Quell is that the new version is operated entirely by an app. It adjusts therapy automatically based on body position and doesn’t need to be turned on and off.

Quell is sold over-the-counter, does not require a prescription and is not usually covered by insurance. Quell 2.0 sells for $299, while the classic Quell is still available at $249. There’s a 60-day money back guarantee for both.

For more information, click here.

Why 'Mindful People' Feel Less Pain

By Pat Anson, Editor

Mindfulness meditation is a form of cognitive behavioral therapy (CBT) that is often recommended to chronic pain patients as a way to temporarily relieve their pain, anxiety and depression. 

Does it work? Pain sufferers report mixed results.

“I have tried CBT and mindfulness. They made me feel much worse emotionally, paradoxically enough, made me more acutely aware of the pain,” one reader told us.

“The quackery continues,” wrote another. “This is a modern day lobotomy experiment.”

“Mindful meditation is a wonderful tool in managing chronic pain and the depression that comes with it,” said another. “Those of us suffering daily need every tool in the shed.”

Researchers at Wake Forest University may have discovered why mindfulness works for some, but not for others. Their brains react differently to meditation.

"We now know that some people are more mindful than others, and those people seemingly feel less pain," said Fadel Zeidan, PhD, an assistant professor of neurobiology and anatomy at Wake Forest School of Medicine.

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WAKE FOREST UNIVERSITY

In a study involving 76 healthy volunteers, Zeidan and his colleagues found that a part of the brain that processes self-related thoughts, feelings and emotions is more active in people who reported higher pain levels during mindfulness meditation.

While practicing mindfulness, MRI’s were taken of the volunteers’ brains as they were exposed to painful heat stimulation (120°F).

Analysis of the MRIs revealed that those who reported lower pain levels when exposed to heat had less activity in the posterior cingulate cortex. Conversely, those that reported higher pain levels had more activity in that critical part of the brain.

"The results from our study showed that mindful individuals are seemingly less caught up in the experience of pain, which was associated with lower pain reports," said Zeidan. "Now we have some new ammunition to target this brain region in the development of effective pain therapies. Importantly this work shows that we should consider one's level of mindfulness when calculating why and how one feels less or more pain." 

The study is being published in the journal PAIN.

A previous study by Zeidan found that mindfulness activates parts of the brain associated with pain control, while it deactivated another brain region (the thalamus) that regulates sensory information. By deactivating the thalamus, meditation may cause signals about pain to simply fade away.

In addition to relieving pain, there is increasing evidence that meditation and CBT are effective in treating mental health issues, such as anxiety, depression and stress. One study, published in the British Medical Journal, found that online mindfulness courses were often just as effective as face-to-face meetings with a therapist.

You can sample a relaxing online pain management meditation at Meditainment.com (click here to see it). The initial course is free.

‘Art Rx’ Museum Tours Relieve Chronic Pain

By Pat Anson, Editor

A small pilot study by researchers at the University of California, Davis has uncovered a novel way of temporarily relieving chronic pain: Visit an art museum.

The Crocker Art Museum in Sacramento hosted a series of “Art Rx” private tours for 56 patients with chronic pain. The one-hour tours were designed not to be physically challenging and to encourage participants to talk with each other about the artwork they were seeing --- not just silently view it.

Patients were surveyed about their pain before and immediately after the docent-led tour, as well as three weeks later.

The study findings, published in the journal Pain Medicine, found that over 57 percent of the patients reported a decrease in their pain levels during the tour.

“So we get there, and I’m already in pain, but truly we were having this discussion and I just wasn’t thinking about it. I was having a good time,” one patient said.

“(Art Rx) took my mind elsewhere,” said another. “Physically I still have pain, but I feel good mentally, and I think part of my pain lessens when I feel good mentally.”

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CROCKER ART MUSEUM

For some, the pain relief lasted for weeks. Several patients noted that the tours made them more aware of how their pain made them socially and emotionally isolated, so they took steps to increase their social interaction. Some met socially with Art Rx participants they met during the tours or joined an art-based community group.

“If you’re involved and doing things with people, you’re not shut in; you’re not focused on the pain,” one participant said.

“If anything it drives home for me how important it was to make sure that I get out," said another. "In a way, it should be an aspect of my health regime.”

“(Participants) found Art Rx to be, among other things, inclusive, validating, and socially engaging. These qualities stood in stark contrast to the isolating nature of chronic pain described in their personal histories and the negative encounters many of them had with the health care system,” wrote lead author Ian Koebner, PhD, a professor at the School of Medicine, University of California, Davis.

“Socially based interventions for individuals with chronic pain supported by health care organizations, such as Art Rx, may help to mitigate not only the experience of isolation, but also the distressing associations that many individuals with chronic pain have with the health care system.”  

The UC Davis findings are similar to those reported recently in a large 10-year study of over 2,600 healthy older adults in England. Researchers found that participants who attended museums, concerts, art galleries and other cultural activities were significantly less likely to develop chronic pain as they grew older.

The "Art Rx" tours at the Crocker Art Museum began in 2014 and are held every other month at no cost to the public. For more information, click here.

How Low Dose Naltrexone Relieved My Chronic Pain

By Marelle Reid, Guest Columnist

For the past eight years I've been dealing with Interstitial Cystitis (IC), a chronic pain condition that feels like a bladder infection that never ends. No one really knows what causes IC and there is no cure.

I've tried everything from surgery and homeopathy to narcotics and antidepressants, but nothing seemed to work until I discovered Low Dose Naltrexone (LDN). A hormone specialist suggested I use LDN as a way to combat the nerve pain that had plagued me for years. I figured I might as well try it since the only side effects from LDN are trouble sleeping and vivid dreams.

 MARELLE REID

MARELLE REID

After a couple of weeks I found the strange dreams stopped, and a few months later I realized I was able to eat foods I normally would avoid because they made my IC pain worse. In fact, I was able to resume a completely normal diet, including foods and drinks that would have previously sent me into terrible flare.

For the past year I've been taking 4.5mg naltrexone at night just before bed. Although it has not cured me, I've been thrilled to find that it has reduced my pain to the point where I no longer feel held back from doing anything I would have done before I was diagnosed with IC. 

Naltrexone is the same drug used to treat alcoholism and opioid addiction. In larger doses (50mg) it blocks opioid receptors in the brain and decreases the desire to take opiates or alcohol.  It's believed that taking naltrexone in smaller doses stimulates the immune system and the production of endorphins, the body's natural painkiller.

LDN is prescribed "off label" for many conditions, but it isn't well known as a treatment for chronic pain because it's not marketed by any drug company for that purpose. The patent on naltrexone expired years ago and there's little money to be made from it or to conduct clinical trials.

However, a review of anecdotal information online and in social media suggests many people suffering from Crohn's disease, multiple sclerosis, fibromyalgia and other chronic illnesses believe they have benefited from taking LDN. (See "Naltrexone Changed Life of Fibromyalgia Patient").

I hope others can find the same relief that I have. 

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Marelle Reid lives in Vancouver, British Columbia.

Pain News Network invites other readers to share their stories with us. Send them to editor@painnewsnetwork.org.

The information in this column should not be considered as professional medical advice, diagnosis or treatment. It is for informational purposes only and represents the author’s opinions alone. It does not inherently express or reflect the views, opinions and/or positions of Pain News Network.

The Man Who Sold America on Vitamin D

By Liz Szabo, Kaiser Health News

Dr. Michael Holick’s enthusiasm for vitamin D can be fairly described as extreme.

The Boston University endocrinologist, who perhaps more than anyone else is responsible for creating a billion-dollar vitamin D sales and testing juggernaut, elevates his own levels of the stuff with supplements and fortified milk. When he bikes outdoors, he won’t put sunscreen on his limbs. He has written book-length odes to vitamin D, and has warned in multiple scholarly articles about a “vitamin D deficiency pandemic” that explains disease and suboptimal health across the world.

His fixation is so intense that it extends to the dinosaurs. What if the real problem with that asteroid 65 million years ago wasn’t a lack of food, but the weak bones that follow a lack of sunlight? “I sometimes wonder,” Holick has written, “did the dinosaurs die of rickets and osteomalacia?”

Holick’s role in drafting national vitamin D guidelines, and the embrace of his message by mainstream doctors and wellness gurus alike, have helped push supplement sales to $936 million in 2017. That’s a ninefold increase over the previous decade. Lab tests for vitamin D deficiency have spiked, too: Doctors ordered more than 10 million for Medicare patients in 2016, up 547 percent since 2007, at a cost of $365 million. About 1 in 4 adults 60 and older now take vitamin D supplements.

But few of the Americans swept up in the vitamin D craze are likely aware that the industry has sent a lot of money Holick’s way.

A Kaiser Health News investigation found that he has used his prominent position in the medical community to promote practices that financially benefit corporations that have given him hundreds of thousands of dollars — including drugmakers, the indoor-tanning industry and one of the country’s largest commercial labs.

In an interview, Holick acknowledged he has worked as a consultant to Quest Diagnostics, which performs vitamin D tests, since 1979.

Holick, who is 72, said that industry funding “doesn’t influence me in terms of talking about the health benefits of vitamin D.”

 DR. MICHAEL HOLICK

DR. MICHAEL HOLICK

There is no question that the hormone is important. Without enough of it, bones can become thin, brittle and misshapen, causing a condition called rickets in children and osteomalacia in adults. The issue is how much vitamin D is healthy, and what level constitutes deficiency.

Windfall for Vitamin D Industry

Holick’s crucial role in shaping that debate occurred in 2011. Late the previous year, the prestigious National Academy of Medicine (then known as the Institute of Medicine), a group of independent scientific experts, issued a comprehensive, 1,132-page report on vitamin D deficiency. It concluded that the vast majority of Americans get plenty of the hormone through diet and sunlight, and advised doctors to test only patients at high risk of vitamin D-related disorders, such as osteoporosis.

A few months later, in June 2011, Holick oversaw the publication of a report that took a starkly different view. The paper, in the peer-reviewed Journal of Clinical Endocrinology & Metabolism, was on behalf of the Endocrine Society, the field’s foremost professional group, whose guidelines are widely used by hospitals, physicians and commercial labs nationwide, including Quest. The society adopted Holick’s position that “vitamin D deficiency is very common in all age groups” and advocated a huge expansion of vitamin D testing, targeting more than half the United States population, including those who are black, Hispanic or obese — groups that tend to have lower vitamin D levels than others.

The recommendations were a financial windfall for the vitamin D industry. By advocating such widespread testing, the Endocrine Society directed more business to Quest and other commercial labs. Vitamin D tests are now the fifth-most-common lab test covered by Medicare.

The guidelines benefited the vitamin D industry in another important way. Unlike the National Academy, which concluded that patients have sufficient vitamin D when their blood levels are at or above 20 nanograms per milliliter, the Endocrine Society said vitamin D levels need to be much higher — at least 30 nanograms per milliliter. Many commercial labs, including Quest and LabCorp, adopted the higher standard.

Yet there’s no evidence that people with the higher level are any healthier than those with the lower level, said Dr. Clifford Rosen, a senior scientist at the Maine Medical Center Research Institute and co-author of the National Academy report. Using the Endocrine Society’s higher standard creates the appearance of an epidemic, he said, because it labels 80 percent of Americans as having inadequate vitamin D.

“We see people being tested all the time and being treated based on a lot of wishful thinking, that you can take a supplement to be healthier,” Rosen said.

Patients with low vitamin D levels are often prescribed supplements and instructed to get checked again in a few months, said Dr. Alex Krist, a family physician and vice chairman of the U.S. Preventive Services Task Force, an expert panel that issues health advice. Many physicians then repeat the test once a year. For labs, “it’s in their financial interest” to label patients with low vitamin D levels, Krist said.

In a 2010 book, “The Vitamin D Solution,” Holick gave readers tips to encourage them to get their blood tested. For readers worried about potential out-of-pocket costs for vitamin D tests — they range from $40 to $225 — Holick listed the precise reimbursement codes that doctors should use when requesting insurance coverage.

“If they use the wrong coding when submitting the claim to the insurance company, they won’t get reimbursed and you will wind up having to pay for the test,” Holick wrote.

Holick acknowledged financial ties with Quest and other companies in the financial disclosure statement published with the Endocrine Society guidelines. In an interview, he said that working for Quest for four decades — he is currently paid $1,000 a month — hasn’t affected his medical advice. “I don’t get any additional money if they sell one test or 1 billion,” Holick said.

A Quest spokeswoman, Wendy Bost, said the company seeks the advice of a number of expert consultants. “We feel strongly that being able to work with the top experts in the field, whether it’s vitamin D or another area, translates to better quality and better information, both for our patients and physicians,” Bost said.

Since 2011, Holick’s advocacy has been embraced by the wellness-industrial complex. Gwyneth Paltrow’s website, Goop, cites his writing. Dr. Mehmet Oz has described vitamin D as “the No. 1 thing you need more of,” telling his audience that it can help them avoid heart disease, depression, weight gain, memory loss and cancer. And Oprah Winfrey’s website tells readers that “knowing your vitamin D levels might save your life.” Mainstream doctors have pushed the hormone, including Dr. Walter Willett, a widely respected professor at Harvard Medical School.

Today, seven years after the dueling academic findings, the leaders of the National Academy report are struggling to be heard above the clamor for more sunshine pills.

“There isn’t a ‘pandemic,’” A. Catharine Ross, a professor at Penn State and chair of the committee that wrote the report, said in an interview. “There isn’t a widespread problem.”

Ties to Drugmakers and Tanning Salons

In “The Vitamin D Solution,” Holick describes his promotion of vitamin D as a lonely crusade. “Drug companies can sell fear,” he writes, “but they can’t sell sunlight, so there’s no promotion of the sun’s health benefits.”

Yet Holick also has extensive financial ties to the pharmaceutical industry. He received nearly $163,000 from 2013 to 2017 from pharmaceutical companies, according to Medicare’s Open Payments database, which tracks payments from drug and device manufacturers. The companies paying him included Sanofi-Aventis, which markets vitamin D supplements; Shire, which makes drugs for hormonal disorders that are given with vitamin D; Amgen, which makes an osteoporosis treatment; and Roche Diagnostics and Quidel Corp., which both make vitamin D tests.

The database includes only payments made since 2013, but Holick’s record of being compensated by drug companies started before that. In his 2010 book, he describes visiting South Africa to give “talks for a pharmaceutical company,” whose president and chief executive were in the audience.

Holick’s ties to the tanning industry also have drawn scrutiny. Although Holick said he doesn’t advocate tanning, he has described tanning beds as a “recommended source” of vitamin D “when used in moderation.”

Holick has acknowledged accepting research money from the UV Foundation — a nonprofit arm of the now-defunct Indoor Tanning Association — which gave $150,000 to Boston University from 2004 to 2006, earmarked for Holick’s research. The International Agency for Research on Cancer classified tanning beds as carcinogenic in 2009.

In 2004, the tanning-industry associations led Dr. Barbara Gilchrest, who then was head of Boston University’s dermatology department, to ask Holick to resign from the department. He did so, but remains a professor at the medical school’s department of endocrinology, diabetes and nutrition and weight management.

In “The Vitamin D Solution,” Holick wrote that he was “forced” to give up his position due to his “stalwart support of sensible sun exposure.” He added, “Shame on me for challenging one of the dogmas of dermatology.”

Although Holick’s website lists him as a member of the American Academy of Dermatology, an academy spokeswoman, Amanda Jacobs, said he was not a current member.

Dr. Christopher McCartney, chairman of the Endocrine Society’s clinical guidelines subcommittee, said the society has put in place stricter policies on conflict of interest since its vitamin D guidelines were released. The society’s current policies would not allow the chairman of the guideline-writing committee to have financial conflicts.

A Miracle Pill Loses Its Luster

Enthusiasm for vitamin D among medical experts has dimmed in recent years, as rigorous clinical trials have failed to confirm the benefits suggested by early, preliminary studies. A string of trials found no evidence that vitamin D reduces the risk of cancer, heart disease or falls in the elderly. And most scientists say there isn’t enough evidence to know if vitamin D can prevent chronic diseases that aren’t related to bones.

Although the amount of vitamin D in a typical daily supplement is generally considered safe, it is possible to take too much. In 2015, an article in the American Journal of Medicine linked blood levels as low as 50 nanograms per milliliter with an increased risk of death.

Some researchers say vitamin D may never have been the miracle pill that it appeared to be. Sick people who stay indoors tend to have low vitamin D levels; their poor health is likely the cause of their low vitamin D levels, not the other way around, said Dr. JoAnn Manson, chief of preventive medicine at Brigham and Women’s Hospital in Boston.

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Only really rigorous studies, which randomly assign some patients to take vitamin D and others to take placebos, can provide definitive answers about vitamin D and health. Manson is leading one such study, involving 26,000 adults, expected to be published in November.

A number of insurers and health experts have begun to view widespread vitamin D testing as unnecessary and expensive. In 2014, the U.S. Preventive Services Task Force said there wasn’t enough evidence to recommend for or against routine vitamin D screening. In April, the task force explicitly recommended that older adults outside of nursing homes avoid taking vitamin D supplements to prevent falls.

In 2015, Excellus BlueCross BlueShield published an analysis highlighting the overuse of vitamin D tests. In 2014, the insurer spent $33 million on 641,000 vitamin D tests. “That’s an astronomical amount of money,” said Dr. Richard Lockwood, Excellus’ vice president and chief medical officer for utilization management. More than 40 percent of Excellus patients tested had no medical reason to be screened.

In spite of Excellus’ efforts to rein in the tests, vitamin D usage has remained high, Lockwood said. “It’s very hard to change habits,” he said, adding: “The medical community is not much different than the rest of the world, and we get into fads.”

Kaiser Health News coverage related to aging and improving care of older adults is supported in part by The John A. Hartford Foundation. KHN is a national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation which is not affiliated with Kaiser Permanente.

Wallowing in Pain

By David Hanscom, MD, Guest Columnist

One of the most powerful ways to bond with others is by sharing emotional or physically painful experiences.  It is common for people suffering from chronic pain to discuss it with their family, friends and colleagues.

Between searching for a cure and talking about it, a fair amount of their consciousness is focused on pain. But the unconscious brain, which pain is a part of, is much more powerful than the conscious brain. You can’t consciously fix or control it. But you can direct it. Your brain changes every second and will develop wherever you place your attention. The more you focus on your pain, the more you will reinforce it.

Many of us in the medical profession were trained to have our pain patients keep a diary of the pain. But it has now been shown in some studies (here and here) that a pain diary is often associated with a delay in recovery. Focusing on the pain and documenting it may only reinforce pain circuits.

One of the most powerful strategies we have seen in treating pain is when we don’t allow patients to discuss their pain with anyone – expect with medical providers. People can become so wrapped up in their pain that they lose themselves in it. They become their pain.

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I had no idea how much time patients spent discussing their pain until I asked them not to. For some, it felt like I had just dumped a bucket of ice water over their head.

They’ll say, “I feel shallow and phony by not sharing what is really going on with me.” That is a sure sign that he or she has become their pain.

We have witnessed several things occur when people successfully stop discussing their pain. The pain may not immediately abate, but they feel lighter.

For starters, do you really think your pain is that interesting to those who aren’t in pain? There is nothing that they can do about it and although they may sympathize, it is incredibly frustrating to repeatedly hear the same story.  Often my patients don’t appreciate the effect their story has on others. People that they enjoyed in the past drift away, furthering their social isolation.

And what about your poor family? They can’t escape as easily. Instead of you being a source of inspiration, peace, love and joy, you bring the whole house down. It isn’t a psychological issue. The effect occurs through mirror neurons, where you are stimulating the negative parts of the brains of those close to you.

Bonding with Pain

Another harmful aspect of repeatedly discussing your pain is that you will bond with those who are also focused on their pain. The bonds are deep and real and stronger than many human connections.

One extreme example of the strength of the need for social interaction involved a patient who we discovered was being violently abused by her boyfriend. We had to call the authorities. But she kept going back to him. One of my staff finally asked her why she put up with being beat up so badly. Her reply was, “It’s the only time that I have his full attention.”

You’ll be almost guaranteed to remain in pain if you are also contributing to another person’s suffering. One of the most basic parts of being human is giving back and that energy is almost impossible to connect to while you are in the abyss of pain. You are taking from those around you and not giving back.

Even deeper though is that the bond forged by pain is so strong that many don’t want to give up their pain. It’s the one greatest obstacle to healing. Being in a victim mode, in any realm, is so powerful that no one willingly wants to let it go. I run across this resistance multiple times per week. It took me many years before I realized that some patients had become addicted to being in pain and were resistant to change. If a patient doesn’t want to even learn the basic concepts behind solving chronic pain, there is nothing that I can do for them.

Our team has attempted to work with several online pain groups, where a lot of energy is spent on complaining about pain, circumstances and medical care. The complaints are generally legitimate, but little time is spent on discussing real alternatives. When we have suggested that there is a viable solution, we are quickly and consistently blocked.

We’ve also asked our patients to never complain or engage in pain behavior, such as groaning, grabbing their back, etc. If you are having a bad day at work or dealing with an unpleasant aspect of your pain, why bring it home? It is supposed to be your haven of safety and relaxation.

Don’t Share Your Pain

We have been surprised how difficult it’s been for some people to quit complaining.  It’s also been surprising how effective this simple strategy has been in moving people forward on their healing journey. At a minimum, their family is happier and everyone’s mood improves. It’s a great start.

Last week I had five different patients become free of pain. All of them had been suffering badly for many years and the change occurred within a couple of months. One person dramatically improved within a couple of weeks. All were beside themselves trying to express how excited and happy they were to be free of pain. Not discussing their pain was a significant step for each of them.

If you are one who feels like that you have to share your pain, then be honest with yourself about not wanting to give it up. It will save you and everyone else a lot of time and money not making the effort to help you heal when you actually don’t want to. Not sharing your pain is a simple beginning and will give you insight on where you are at with regards to healing.

Many people are incensed at the idea that they don’t want to give up their pain. The response is often that the medical profession just isn’t doing its job and fixing them. Whether that is true or not isn’t the point. The key is that you aren’t willing to learn the most recent concepts about overcoming pain. There isn’t any risk and you are already spending a good deal of time searching for an answer.

If you really think you aren’t attached to your suffering, then try this simple test:  Don’t talk about your pain.

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Dr. David Hanscom is a spinal surgeon who has helped hundreds of back pain sufferers by teaching them how to calm their central nervous systems without the use of drugs or surgery. In his book Back in ControlHanscom shares the latest developments in neuroscience research and his own personal history with pain.

More information can be found on his website.

The information in this column should not be considered as professional medical advice, diagnosis or treatment. It is for informational purposes only and represents the author’s opinions alone. It does not inherently express or reflect the views, opinions and/or positions of Pain News Network.

Prescription Pain Creams Flagged for Medicare Fraud

By Julie Appleby, Kaiser Health News

Medicare pays hundreds of millions of dollars each year for prescription creams, gels and lotions made-to-order by pharmacies — mainly as pain treatments. But a new report finds that officials are concerned about possible fraud and patient safety risks from products made at nearly a quarter of the pharmacies that fill the bulk of those prescriptions.

“Although some of this billing may be legitimate, all of these pharmacies warrant further scrutiny,” concludes the report from the Office of the Inspector General for the Department of Health and Human Services.

In total, 547 pharmacies — nearly 23 percent of those that submit most of the bills to Medicare for making these creams — hit one or more of five red-flag markers set by investigators.

Those included what the researchers called “extremely high” prices; large percentages of Medicare members getting identical drugs — 16 of the pharmacies billed for identical drugs for 200 or more customers; “greatly increased” year-over-year billing — 20 pharmacies increased their billing by more than 10,000 percent; or having a single medical provider writing more than 131 prescriptions.

More than half of those pharmacies hit two or more measures — and 10 hit all five.

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One Oregon pharmacy, for example, submitted claims for 91 percent of its customers. A pharmacy in New York submitted 5,342 prescriptions ordered by one podiatrist, while a Florida pharmacy saw its Medicare billing for such treatments go from $7,468 in 2015 to $1.8 million the following year.

Many of the pharmacies are clustered in four cities: Detroit, Houston, Los Angeles and New York.

The report comes amid ongoing concern by Medicare officials about these custom-made — or compounded — drugs. In addition to questions like those raised in the report about overuse and pricing, safety has been a key issue in recent years. A meningitis outbreak in 2012 was linked to a Massachusetts pharmacy that did not maintain sterile conditions and sold tainted made-to-order injections that killed 64 Americans.

When done safely, pharmacy-made compounded drugs provide a legitimate option for patients whose medical needs can’t be met by commercially available products mass-produced by pharmaceutical companies. For example, a patient who can’t swallow a commercially available prescription pill might get a liquid version of a drug.

State boards of pharmacy generally oversee compounding pharmacies, and the drugs they produce are not considered approved by the Food and Drug Administration.

Rising Cost of Compounded Drugs

The new report focuses on concerns with compounded topical medications.

Medicare spending for such treatments has skyrocketed, rising more than 2,350 percent, from $13.2 million in 2010 to $323.5 million in 2016. Price hikes and an increase in the number of prescriptions written drove the increase, the report said.

It is not the first time the inspector general has looked at compounded drugs. A 2016 report found that overall spending on all types of compounded drugs — not just topical medications — rose sharply.

The U.S. Postal Service inspector general and the Department of Defense also have raised concerns about rising spending and possible fraud for compounded drugs.

In response to those previous reports, the International Academy of Compounding Pharmacists, the industry’s trade group, has said that legitimately compounded drugs “can dramatically improve a patient’s quality of life,” noting that proper billing controls need to be in place. The inspector general’s report in 2016, it added, found that “such controls are not in place.”

This report, which the compounding trade group has not yet reviewed, focuses on topical drugs and a subset of the 15,290 pharmacies that provide at least one such prescription each year. It looked at billing records from the 2,388 pharmacies that do at least 10 such prescriptions a year — providing 93 percent of all compounded topical drugs paid for by Medicare.

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Most of the prescriptions were for pain treatment, made from ingredients such as lidocaine, an anesthetic, or diclofenac sodium, an anti-inflammatory drug.

On average, those compounds were more expensive than non-compounded drugs with the same ingredients.

For example, Medicare paid an average of $751 per tube of compounded lidocaine, and $1,506 for the diclofenac, according to the inspector general’s report. Non-compounded tubes of those drugs averaged $445 and $128, respectively.

FDA Commissioner Scott Gottlieb recently outlined new efforts his agency is taking to oversee compounded drugs in the wake of legislation passed by Congress following the meningitis outbreak.

“The FDA is inspecting compounding facilities to assess whether drugs that are essentially copies of FDA-approved drugs are being compounded for patients” who could otherwise take a product sold commercially, he said in a statement issued on June 28.

Gottlieb also said the FDA plans to make more information available to patients and their doctors about compounded topical pain creams, including information about their effectiveness and any potential safety risks.

Not being effective is a safety risk, noted Miriam Anderson, a researcher with the inspector general’s office who helped write the report.

The report urged the Centers for Medicare & Medicaid Services to clarify some of its policies to emphasize that insurers can limit the use of compounded drugs by requiring prior authorization or other steps. The agency concurred with the recommendations, according to the report, including the need to “follow up on pharmacies with questionable Part D billing and the prescribers associated with these pharmacies.”

Anderson said the inspector general’s office is continuing to probe the issue.

“We will investigate a number of leads on specific pharmacies and prescribers who were identified as having these questionable patterns,” she said. “Whenever we see that kind of increase in spending, it raises concern about fraud, waste and abuse.”

Kaiser Health News’ coverage of prescription drug development, costs and pricing is supported in part by the Laura and John Arnold Foundation.

Kaiser Health News, a nonprofit health newsroom whose stories appear in news outlets nationwide, is an editorially independent part of the Kaiser Family Foundation.

Why ‘The Bleeding Edge’ Gave Me a Panic Attack

By Emily Ullrich, Guest Columnist

If you haven't seen it yet, you've likely heard the buzz about The Bleeding Edge on Netflix. This documentary should be seen by every adult in America, not just chronically ill or chronic pain patients.

The Bleeding Edge gives insight and affirmation to those of us who have dealt with the medical system a little too much and demonstrates how important self-advocacy is. If you haven't seen it yet, don't let what I'm about to tell you deter you. I've seen it twice now. The first time I watched it, I had a full-on panic attack because it reminded me of the infuriating ordeal I went through dealing with the American medical system.

I wanted to watch the film again, hoping I would be able to watch it more objectively. I made it through the second time without a panic attack, but I was still yelling at the screen.

The film covers an array of medical device errors and malfunctions. But more importantly, it also delves into the mistakes and oversights that the FDA, CDC, American Medical Association and others have made (and continue to make) at the expense of our health because it's more lucrative to make us sick than it is to ensure our safety.

One of the main topics in The Bleeding Edge is the autoimmune disorders that many women developed after the implantation of the Essure birth control device. I was especially stricken by this story.

My first experience with chronic pain was pelvic pain, due in part to endometriosis. I started having my periods when I was 11 years old, and by age 12 was literally passing out because of the severe pain I had when menstruating. I saw doctor after doctor, and every one of them told me the same three things:

“This is normal.”

“At least part, if not all of this, is psychological.”

“Take ibuprofen and a hot bath, and you'll be fine.”

Of course, they were all wrong.

By age 19, I went to probably my twelfth doctor. She decided, in her infinite and culturally superior attitude, that since I had two sexual partners in my lifetime that I must be promiscuous. And if I continued this reckless behavior, she would not be able treat me and would be forced to tell my parents. When I told her I didn't need to be judged or lectured, she clucked her tongue and shook her head, as though I was a lost cause.

Many years and irresponsible, uncaring and uninformed doctors later, at age 31, I went to a doctor who told me I probably had endometriosis and performed a laparoscopic procedure to confirm this diagnosis. The procedure was also supposed to remove it and I was supposed to feel better. It didn't.

As I aged, it got worse. And as I moved around the country, I had to go through the degrading and exasperating experience of finding a doctor who believed me and believed in endometriosis. Many OB/GYN's and MD's still do not.  Even now, I see doctors on occasion who refer to it as a “garbage pail diagnosis.”

The Mirena IUD

At age 36, I was finally referred to a pelvic pain specialist. He believed in my pain and suffering and wanted to help. I cried because he was so nice.

After a fourth endometrial ablation surgery, he suggested the Mirena IUD as a long-term solution to my problem. He said it would not only prevent pregnancy but would be effective in reducing or eliminating my periods. As I lay back to have the IUD inserted, he assured me that it would not be painful that I would merely feel a “slight pinch.”

I never felt ANYTHING as excruciatingly painful. The doctor mistakenly punctured the fundus of my uterus. So, he casually penetrated me again with the same invasive tools, pulled the IUD out, opened a new one and attempted to place it. My uterus simply spat it back out at him. He said, laughing, “Your body doesn't seem to like this! Wanna try it again?”

I should have listened to my body and said no. But he tried again and finally placed it. For the next nine months. I bled profusely every day and the pain was worse than ever. I called and visited the doctor numerous times throughout these months, and every time he assured me the bleeding would stop and I should be patient.

Finally, I marched into an appointment and demanded he remove it. He did, and although I had pain for the next few days, it finally got a little better.

My point in all of this is that I now have about 15 chronic pain conditions. And with each one, I have a similar horror story. I feel a connection to the women who had the Essure device and who later developed autoimmune illnesses because of it. I will never know if any of my ongoing list of health problems stemmed from the Mirena, but I do know that after my bad experience with it and a few other attempted medical devices, my body doesn't respond well to foreign objects.

We are all different chronic pain snowflakes, if you will, and different treatments work for different people. However, as one goes through the process of repetitive ER visits, hospital admissions and doctor's appointments, we get to know what we can and cannot tolerate pretty well.

The pain patients' mantra of “Be Your Own Best Advocate” could not be hammered home better than it was watching The Bleeding Edge. The film struck a deep chord within me about the irresponsibility of our government, medical companies and doctors, as well as their willingness to suspend disbelief if it is easier and more financially convenient, even if it's at the cost of people's lives.

It is very much like the movement to stop the use of opioids, a proven and mostly safe class of pain medication, while encouraging the use of under-tested drugs with bad side effects that are often prescribed off label to treat conditions they were never intended for. It doesn't matter anymore if the patient has a better life or not. It only matters that the medical system drains our wallets and souls, while selling theirs.

Still, after all of this, we have to fight. We have to because no one else is going to do it for us. We have to do our own research and educate ourselves about medical devices and treatments.

As The Bleeding Edge demonstrates, when you can buy stock in healthcare companies, when government became controlled by corporations, and when doctors get paid for using and recommending their products, we lost the ability to trust them. 

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Emily Ullrich lives with Complex Regional Pain Syndrome (CRPS), Sphincter of Oddi Dysfunction, Carpal Tunnel Syndrome, endometriosis,  Interstitial Cystitis, migraines, fibromyalgia, osteoarthritis, PTSD, insomnia, bursitis, depression, multiple chemical sensitivity, and chronic pancreatitis.

The information in this column should not be considered as professional medical advice, diagnosis or treatment. It is for informational purposes only and represents the author’s opinions alone. It does not inherently express or reflect the views, opinions and/or positions of Pain News Network.

Magnetic Gel Could Someday Treat Chronic Pain

By Pat Anson, Editor

Magnet therapy has been used for thousands of years to treat arthritis, inflammation and other chronic illnesses. Today therapeutic magnets can be found in bracelets, shoes, clothing, mattresses and dozens of other products, sold by companies that claim magnets relieve pain, improve blood flow and even flush out toxins.

It's a controversial theory and there is little science to support the medical use of magnets. One critic has even called magnet therapy “a billion-dollar boondoggle.”  

But maybe there’s something to it after all.

UCLA researchers have demonstrated that a gel-like material containing tiny magnetic particles can be used to relieve chronic pain caused by disease or injury. In a study published in the journal Advanced Materials, they say the biomechanical force of magnets can be used on damaged cells to help them heal.

"Much of mainstream modern medicine centers on using pharmaceuticals to make chemical or molecular changes inside the body to treat disease," says principal investigatorDino Di Carlo, PhD, a UCLA professor of bioengineering. "However, recent breakthroughs in the control of forces at small scales have opened up a new treatment idea -- using physical force to kick-start helpful changes inside cells. There's a long way to go, but this early work shows this path toward so-called 'mechanoceuticals' is a promising one."

Di Carlo and his colleagues used magnetic particles inside a gel to manage cell proteins that control the flow of calcium ions. The proteins are on the cell's membrane and play a role in the sensations of touch and pain. When damaged by injury or disease, these “excitable” neuron cells continually send pain signals.

"Our results show that through exploiting 'neural network homeostasis,' which is the idea of returning a biological system to a stable state, it is possible to lessen the signals of pain through the nervous system," said lead author Andy Kah Ping Tay, a recent UCLA doctoral graduate. "Ultimately, this could lead to new ways to provide therapeutic pain relief."

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UCLA IMAGE

To make the magnetized gel, UCLA researchers used hyaluronic acid, a gel-like material found naturally in the spinal cord and brain. Hyaluronic hydrogel can also be produced artificially and is used in cosmetics and other beauty products as a filler and moisture barrier.

The researchers put tiny magnetic particles into the gel and then grew a type of primary neural cell -- dorsal root ganglion neurons – embedded inside the gel. In laboratory tests, they applied a magnetic field to generate a pulling force on the particles, which was transmitted through the gel to the embedded neurons.

The researchers found that the magnetically induced pulling led to an increase in calcium ions in the neurons. When they increased the magnetic force steadily over time, the neurons adapted to the continuous stimulation by reducing the signals for pain. In effect, researchers created a form of neuromodulation using magnets -- an old theory put to a new use.

In addition to treating pain, researchers say the magnetic gel could be modified with different biomaterials to treat heart disease, muscle disorders and other health conditions.

The UCLA research was funded by a New Innovator Award grant from the National Institutes of Health.

Indiana Paramedics Use Laughing Gas to Treat Pain

By Pat Anson, Editor

They say laughter is the best medicine, but an Indiana fire department has taken that cliché a step further by using “laughing gas” to treat emergency patients.

This week paramedics in the Indianapolis suburb of Fishers became the first in the state to use nitrous oxide for pain management when a patient suffers a broken bone, sprain or some other injury.  The goal is to reduce the use of prescription fentanyl – a potent opioid – and run the risk of a patient becoming addicted.  Fentanyl is currently used to manage pain in about 10 percent of Fishers’ emergency transports.

“It really comes down to the number of overdoses that we respond to. Fishers is not immune to that problem and we're trying to look at any and all ways that we can prevent people becoming addicted to opioids," Fishers Fire Captain John Mehling told WTTV. “If we can take even a little piece of that out of the care for the patients that we deal with, that might be that one step that keeps them from becoming addicted.”

Fire officials say patients must be alert enough to administer the gas themselves by holding a mask over their face while under the supervision of a paramedic. It takes about 2 to 3 minutes for the nitrous oxide to reduce pain and anxiety.    

“This is an effective and responsible adjustment to the care of our patients without the introduction of opiates into their system when possible,” said Fisher Fire Chief Steven Orusa.

Nitrous oxide has long been used to manage pain during dental procedures and is commonly used in European and Australian ambulances. It’s use by paramedics in the United States is relatively new.

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Laughing gas is also making a comeback in some U.S. hospitals, where it is offered as an alternative to epidurals for labor pain. St. Joseph’s Regional Medical Center in New Jersey has incorporated nitrous oxide into its “Alternative to Opiates” program, along with dry needles, nerve blocks and music therapy. St. Joseph’s has drawn international attention for significantly reducing the use of opioids in its emergency room, but is rated as one of the worst hospitals in the country by patients, who complain of poor pain care and long wait times.

Although nitrous oxide is considered safer than opioids, it has a long history of being abused for its euphoric effects. The gas was first used in “laughing gas parties” 200 years ago in Great Britain and is still used today by recreational drug users. When inhaled without oxygen mixed in, nitrous oxide can cause blood pressure to drop suddenly and lead to fainting and heart attacks.

Do Cultural Activities Reduce Risk of Chronic Pain?

By Pat Anson, Editor

Lose weight and get regular exercise are two health tips we’ve all heard before. But has anyone told you that going to a museum or concert could reduce your risk of developing chronic pain?

It’s true, according to a novel study published in the Journal of Pain.

Researchers looked at data from a 10-year study that tracked the progression of pain in over 2,600 older adults living in England. None of the participants suffered from chronic pain at the start of the study, but after ten years over 42 percent had experienced moderate to severe chronic pain.

Women (60%) were more likely to report chronic pain, along with those who lived alone, had less education, less wealth, slept poorly or were depressed. No surprise there, as many studies have found those conditions are often associated with chronic pain.

Researchers also wanted to know how often people exercised or participated in social events, such as community groups (political parties, trade unions or sports clubs) or cultural activities (visiting museums, art galleries or concerts).

Interestingly, moderate physical exercise appeared to have no effect on the incidence of chronic pain, but regular vigorous activity such as stretching and endurance training reduced the risk of developing pain, especially when it was combined with cultural activities.

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“This study also found evidence that psychosocial factors may be protective against the development of chronic pain, in particular engagement in cultural activities such as going to museums, art galleries, exhibitions, concerts, the theatre or the opera,” wrote lead author Daisy Fancourt, PhD, a senior research associate at University College London. "It is notable that the odds ratios for cultural engagement were directly comparable with those of vigorous physical activity, suggesting a reduction of 25-26% in risk of chronic pain incidence."

Fancourt and her colleagues believe that going to a museum or concert provides not only gentle physical activity, but psychological benefits that come from social engagement and having positive cultural experiences.

“Notably, these positive psychological benefits have not been found consistently for community group membership, which could explain the differences in association with chronic pain found in this study. Indeed, it is notable that for participants who experienced widespread pain, only psychosocial factors, not physical factors, were found to be risk-reducing,” said Fancourt.

The study was observational in nature and does not prove that cultural experiences can prevent chronic pain. But unlike dieting and exercise, it does suggest an alternate way to lower the risk of chronic pain that most people would find enjoyable.  And maybe that's the most important lesson.

"This study is the first to explore simultaneously potential physical and psychosocial protective factors for the development of chronic pain in older adults. Our results demonstrate that both vigorous weekly activity and regular cultural engagement appear to reduce risk of incident chronic moderate-severe pain," the researchers concluded.

Obese Adults More Likely to Have Chronic Pain

Another way to reduce your risk of chronic pain is to maintain a healthy weight, according to a recent Washington State University study. Researchers there looked at data from 9 large studies conducted in different countries to calculate the odds of chronic pain among adults with an overweight body mass index (BMI).

They found that adults with a BMI of 25 or more, which is considered overweight or obese, were 14 to 71 percent more likely to suffer from chronic pain than those with a BMI below 25.

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“Previous studies have shown that weight gain often precedes the development of chronic pain by many years, so I think our job as medical providers is to educate our patients early on and say, ‘You have a high BMI, your risk of one day developing a chronic pain condition, in addition to heart disease, is much higher,’” says Teresa Bigand, a doctoral student in the WSU College of Nursing.

“I think we need to do a better job of educating overweight people about their risk of potentially developing a chronic pain condition.”

More than 69 percent of the U.S. population and 1.9 billion people worldwide are overweight. For those who are already overweight and suffering from a chronic pain, Bigand says it’s not too late to take action. Research shows people who lose the largest amount of weight have the largest drop in their pain intensity.

“Essentially, weight loss is the best thing to do, however some patients aren’t quite ready for that,” Bigand said. “Patients with the highest and most severe levels of pain intensity struggle the most to lose weight. In those cases, we have to think about how we can help patients get their other symptoms under control that might be exacerbating the pain before we can start thinking about treating their overweight or obese status.”

A recent University of Michigan study, published in The Journal of Pain, found that obese participants who lost at least 10 percent of their body weight had less overall body pain.

“It’s been known for some time that people who are obese tend to have higher levels of pain, generally speaking,” says Andrew Schrepf, PhD, a research investigator at Michigan Medicine’s Chronic Pain and Fatigue Research Center. “But the assumption has always been the pain is going to be in the knees, hips and lower back — parts of the body that are weight-bearing.”

Schrepf and his colleagues found that losing weight not only lowered pain levels in the knees and hips, but in unexpected areas such as the abdomen, arm, chest and jaw. Study participants who could reach the goal of losing 10% of their weight also reported better mental health, improved cognition and more energy. Men in particular showed improvements in their energy levels.

Modified Botox Could Treat Chronic Pain

By Pat Anson, Editor

Injections of botulinum toxin -- more widely known as the brand name Botox -- have long been used as a cosmetic treatment that reduces wrinkles by causing muscles under the skin to relax. British researchers say a modified version of that same neurotoxin could someday be used to treat chronic pain.

In a study published in the journal Science Translational Medicine, scientists reported that they had deconstructed the botulinum molecule and reassembled it with a strong opioid called dermorphin to make "Derm-BOT" – a compound that blocks pain signals from neurons in the spinal cords of mice.

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“Injected into the spine, Derm-BOT relieves chronic pain – such as that caused by nerve damage – and avoids the adverse events of tolerance and addiction often associated with repeated opioid drug use,” said co-author Steve Hunt, PhD, a professor in cell and developmental biology at University College London (UCL).

“It doesn’t affect muscles like the botulinum toxin used to reduce wrinkles but it does block nerve pain for up to four months without affecting normal pain responses. It really could revolutionize how chronic pain is treated if we can translate it into clinic."

So far, Derm-BOT has only been used on laboratory mice, so don't expect it to be available for humans anytime soon. Over a five year period, 200 mice were treated with a single injection of either Derm-BOT, SP-BOT (another modified botulinum molecule) or morphine. The behavior of the mice was observed to track their response to pain.

“Both SP-BOT and Derm-BOT have a long-lasting effect in both inflammatory and neuropathic pain model, successfully silencing neurons without cell death. We were impressed to see that one tiny injection was enough to stop chronic pain caused by inflammation and nerve damage for at least a month," said lead author Maria Maiarù, PhD, a research associate at UCL. “A single injection of Derm-BOT reduced mechanical hypersensitivity to the same extent as morphine."

Previous studies in rats and dogs show that injections of tiny amounts of toxic substances into the spine kill neurons responsible for chronic pain. In contrast, scientists say Derm-BOT does not kill neurons, is safe to manufacture and non-toxic. And although it is partially made with an opioid, it is not addictive and doesn't cause respiratory depression.

"Injected into the spine, Derm-BOT relieves chronic pain -- such as that caused by nerve damage -- and avoids the adverse events of tolerance and addiction often associated with repeated opioid drug use," Hunt said.

Botox injections are already used to treat conditions such as migraines, neuropathic pain, and some allergies. But those injection are made into the skin and muscles, not directly into the spinal cord.