FDA Warns About Unapproved Drugs in Pain Pumps

By Pat Anson, PNN Editor

The U.S. Food and Drug Administration is warning patients and healthcare providers about serious complications that can occur when using medications not approved for use with intrathecal pain pumps. The agency says it has received “numerous reports” of pump failures, dosing errors, infections and other safety issues.

Pain pumps are implanted under the skin, usually near the abdomen, and deliver medication through a catheter directly into spinal fluid to treat chronic pain. They require a healthcare provider to periodically refill the pump with pain medication. The pumps are generally used as a last resort for patients whose pain is not adequately managed by oral medication, surgery and other treatments.

Currently, there are only two FDA-approved medications for intrathecal pain pumps; Infumorph (a morphine sulfate solution) and Prialt (a sterile solution).

Drugs approved for intrathecal administration must meet additional safety standards because the spinal cord and brain tissue are highly sensitive to preservatives or infectious organisms such as bacteria or viruses.

The FDA has found that some patients are being treated with medications that are not approved for pain pumps – including hydromorphone, bupivacaine, fentanyl and clonidine – as well as compounded medications.

One reason patients may not be using Infumorph is that it is currently listed on the FDA’s drug shortage list. Some patients may also believe the unapproved drugs are more effective, although the FDA says they are still too risky.  

“While medical devices, such as implanted pumps that deliver medication directly into the spinal fluid, have the potential to play an important role in treating pain, their use must be judicious and their instructions for use must be carefully followed. This is especially true when it comes to implantable pumps that deliver analgesic medicine directly into the nervous system,” FDA Commissioner Scott Gottlieb, MD, said in a statement.

The FDA says the failure rate of the pumps more than doubles when unapproved medications are used. Some drugs may contain preservatives that can damage the pump tubing or cause corrosion. Dosing errors can also occur because the software on pain pumps is only designed to calibrate doses with approved medications.

“FDA acknowledges that some patients being treated for pain may not be adequately managed by medicines approved for use with these pumps; however, the use of medicines not approved with the implanted pumps are associated with additional risks,” the agency said. “The FDA recommends that health care providers review the implanted pump labeling to identify the medicines and medicine concentrations approved for use with the specific pump.”

Patients and providers who experience an adverse event with an implanted pump or suspect one is having problems are encouraged to file a voluntary report through MedWatch, the FDA Safety Information and Adverse Event Reporting program.

A Painkilling Brew for Whatever ‘Ales’ You

By Steve Weakley

When anesthesiologist Admir Hadzic, MD, isn’t putting patients to sleep he’s putting them in a better mood with his Dr. Blues Belgian Brews.

Hadzic brews a potent dark beer called “PainKiller” that has 10% alcohol content, an award-winning blonde ale named “NerveBlock” that will make you comfortably numb, and a pilsner IPA called “SuperPills” that’ll make you hoppy.

References to the medicinal benefits of beer date back to the ninth century. For a short period during Prohibition, doctors even prescribed “medical beer” for patients who could no longer buy their brew legally without a prescription.

Dr. Hadzic, who was born in Yugoslavia and is a naturalized U.S. citizen, came up with the idea for medically themed malts when he married a Belgian anesthesiologist and moved to her country.

Belgium is the largest beer exporting country in Europe and Hadzic quickly fell in love with its chief export. He partnered with two local brewers to produce his own line of specialty beers.

In addition to being a practicing anesthesiologist, Hadzic is a blues bassist and has his own band, the “Big Apple Blues.” His beers actually ferment to the recorded sounds of his slide guitar.

“Since I’m a doctor and I play blues music, I’ll call it Dr. Blues Belgian Brews,” Hadzic told Pain Medicine News.

In addition to PainKiller, NerveBlock and SuperPills, Dr. Blues makes a malty “PaceMaker” beer and the non-alcoholic “Placebo” beer -- for people who like the flavor but not the buzz and can’t tell difference anyway. Placebo is so popular it’s already sold out for the year.

Dr. Blues beers are only available online and while a lot of the marketing is tongue-in-cheek, they’re also careful not to encourage excessive alcohol consumption. The website links to a recent Lancet study that found no amount of alcohol improves health, as some studies have suggested.

“DR BLUES does not promote drinking. Instead, he brews his recipes for the lucky, consenting few, who like him, insist on a unique story & experience for special occasions,” the website cautions.

Hadzic maintains a website, “Dr. Blues.com” that has fascinating factoids about his favorite beverage. You may not know that China is the world’s largest beer consuming nation or that Scotland’s “Snake Venom” is the world’s most potent beer at 67.5% alcohol.  Snake Venom is also one of the world’s most expensive brews at $67 a bottle.

If you are ever in Belgium and in need of beer, blues or anesthesia, look up Dr. Blues. He’s your one stop for the best of all three.

Pain App Lets Patients ‘Paint’ Their Pain

By Pat Anson, PNN Editor

There are dozens of mobile apps that can help chronic pain patients track their symptoms, send reports to doctors, get health tips and even keep tabs on the weather.

GeoPain, a free app recently launched by a University of Michigan startup, takes the technology a step further. Instead of just giving a single number on a pain scale of zero to 10, patients can “paint” their pain on multiple locations on a 3D image of the human body.

The app’s creators say visually mapping the pain gives doctors a better idea of the pain’s location, severity, it’s possible cause and the best way to treat it.

“We can dissect the pain with greater precision, in one patient or several, and across multiple body locations,” says Alexandre DaSilva, co-founder of MoxyTech and director of the Headache & Orofacial Pain Effort Laboratory at the U-M School of Dentistry.

“Whether the patient has a migraine, fibromyalgia or dental pain, we can measure whether a particular medication or clinical procedure is effective for each localized or spread pain condition. Geopain is a GPS for pain health care.”

Patients can also use GeoPain to show their doctors a visual recording of a pain flare long after the flare has ended.

“What patients are responding to the most is the visual tracking of their pain over time. They have shared some great stories of how they can now cleary show doctors how their pain has changed, which helps give them credibility and speeds up treatment,” Eric Maslowski, MoxyTech’s co-founder and chief technology officer, wrote in an email to PNN.

“Many clinicians like the visual nature of the app and ease of use. What was surprising to us initially was their interest in it for documenting patient visits for insurance and liability.” 

The app was initially created to track pain in patients enrolled in studies on migraine and chronic pain at the University of Michigan. Research showed that GeoPain data directly correlates with opioid activity in the brains of chronic pain patients, suggesting it might be useful in clinical trials to measure the effectiveness of pain medication.

The free app is available at Google Play, Apple’s App Store and at GeoPain.com.

Can a Rare Moss Be Used As a Painkiller?

By Pat Anson, PNN Editor

Cannabis, kava and kratom have some competition. Swiss scientists say a rare moss-like plant could be another natural substance that can treat pain and inflammation. And it’s completely legal.

Radula perrottetii is a member of the liverwort family that only grows in Japan, New Zealand, Tasmania and Costa Rica. It produces a molecule called perrottetinene (PET) that is remarkably similar to tetrahydrocannabinol (THC), the psychoactive ingredient found in cannabis. 

"It's astonishing that only two species of plants, separated by 300 million years of evolution, produce psychoactive cannabinoids," says Jürg Gertsch, PhD, a professor in the Institute of Biochemistry and Molecular Medicine at the University of Bern.

UNIVERSITY OF BERN

A few year ago, Gertsch learned that dried samples of liverwort were being advertised on the internet as incense that produces so-called "legal highs." At the time, little was known about the pharmacological effects of PET, so Gertsch and his colleagues set out to discover how the substance works.

In studies on laboratory mice, they found that PET reaches the brain very easily and that it activates the same cannabinoid receptors that THC does. PET also has a strong anti-inflammatory effect, which makes it potentially useful as a painkiller.

Because PET produces only a mild degree of euphoria, researchers believe it has low abuse potential and fewer side effects than THC.  

Gertsch and his colleagues recently published their findings in the journal Science Advances. They plan to conduct more extensive animal testing before any clinical trials on humans. And that could take years.

In the meantime, liverwort is already being used for medicinal purposes. “Despite serious safety concerns,” WebMD says liverwort is used to treat gallstones, liver conditions, varicose veins and menopause. Others uses include “strengthening nerves” and stimulating metabolism.

Amazon and eBay advertise liverwort – not as medicine – but to help decorate terrariums and aquariums.

Gene Therapy Eases Chronic Pain in Dogs

By Lisa Marshall, University of Colorado at Boulder

When Shane the therapy dog was hit by a Jeep, life changed for him and his guardian, Taryn Sargent.

The impact tore through the cartilage of Shane's left shoulder. Arthritis and scar tissue set in. Despite surgery, acupuncture and several medications, he transformed from a vibrant border collie who kept watch over Sargent on long walks to a fragile pet who needed extensive care.

"Sometimes he would just stop walking and I'd have to carry him home," recalls Sargent, who has epilepsy and relies on her walks with Shane to help keep her seizures under control. "It was a struggle to see him in that much pain."

Today, 10-year-old Shane's pain and reliance on medication have been dramatically reduced and he's bounding around like a puppy again, 18 months after receiving a single shot of an experimental gene-therapy invented by CU Boulder neuroscientist Linda Watkins

shane and taryn sargent (casey cass/cu boulder)

Thus far, the opioid-free, long-lasting immune modulator known as XT-150 has been tested in more than 40 Colorado dogs with impressive results and no adverse effects. With human clinical trials now underway in Australia and California, Watkins is hopeful the treatment could someday play a role in addressing the nation's chronic pain epidemic.

"I'm hoping the impact on pets, their guardians and people with chronic pain could be significant," said Watkins, who has worked more than 30 years to bring her idea to fruition. "It's been a long time coming."

The Role of Glial Cells

Watkins' journey began in the 1980s when, as a new hire in the department of psychology and neuroscience, she began to rock the boat in the field of pain research.

Conventional wisdom held that neurons were the key messengers for pain, so most medications targeted them. But Watkins proposed that then-little-understood cells called "glial cells" might be a culprit in chronic pain. Glial cells are immune cells in the brain and spinal cord that make people ache when they're sick. Most of the time, that function protects us. 

Watkins proposed that in the case of chronic pain, which can sometimes persist long after the initial injury has healed, that ancient survival circuitry somehow gets stuck in overdrive. She was greeted with skepticism.

"The whole field was like 'what on Earth is she talking about?'"

She and her students hunkered down in the lab nonetheless, ultimately discovering that activated glial cells produce specific inflammatory compounds which drive pain. They also learned that, after the initial sickness or injury fades, the cells typically produce a compound called Interleukin 10 (IL-10) to dampen the process they started.

"IL-10 is Mother Nature's anti-inflammatory," she explains. "But in the onslaught of multiple inflammatory compounds in chronic pain, IL-10's dampening cannot keep pace."

Over the years, she and her team experimented with a host of different strategies to boost IL-10. They persisted and, in 2009, Watkins co-founded Xalud Therapeutics. Their flagship technology is an injection, either into the fluid-filled space around the spinal cord or the site of an inflamed joint, that delivers circles of DNA in a sugar/saline solution to cells, instructing them to ramp up IL-10 production.

With financial help from the National Institute of Neurological Disorders and Stroke, the MayDay Fund and CU's Technology Transfer Office – which has provided intellectual property support, assistance with licensing agreements, and help obtaining a $100,000 research grant in 2018 – Watkins is edging closer to bringing her idea to clinical practice.

She has teamed up with veterinary chronic pain specialist Rob Landry, owner of the Colorado Center for Animal Pain Management in Westminster, to launch the IL-10 research study in dogs.

Their results have not been published yet. But thus far, the researchers say, the results look highly promising.

"They're happier, more engaged, more active and they're playing again," said Landry, as he knelt down to scratch Shane's belly after giving him a clean bill of health.

With Shane able to accompany her on her walks again, Sargent has also seen her quality of life improve. Her seizures, which increased in frequency when Shane was injured, have subsided again.

linda watkins with shane (casey cass/cu boulder)

Human Studies Underway

Because the treatment is so localized and prompts the body's own pain-killing response, it lacks the myriad side effects associated with opioids – including constipation and dependency – and it can last for many months after a single injection.

Ultimately, that could make it an attractive option for people with neuropathic pain or arthritis, Watkins says.

This summer, Xalud Therapeutics launched the first human study in Australia, to test the safety, tolerability and efficacy of the compound. Another one-year clinical trial of 32 patients with osteoarthritis of the knee is now underway in Napa, California.

More research is necessary in both pets and people, Watkins stresses. But she's hopeful.

"If all goes well, this could be a game-changer."

Social Media Lowers Depression Risk for Pain Patients

By Pat Anson, PNN Editor

Seniors citizens who have chronic pain are significantly less likely to suffer from depression if they participate in an online social network, according to a new study.

Researchers at the University of Michigan reviewed the results of a 2011 survey of more than 3,400 Medicare patients aged 65 and older, in which respondents were asked about their depression, pain and social participation. About 17% of the seniors used an online social network in the previous month.

Researchers found that seniors who had chronic pain were often depressed, socially isolated and less likely to participate in activities that require face-to-face interaction.

However, online social participation appeared to buffer the impact of pain on depression. Seniors in pain who did not use an online social network were twice as likely to become depressed.

“The results suggest that for those in pain, it may be possible that online social participation can compensate for reduced offline social participation, especially where it pertains to the maintenance of mental health and well-being. This is critical because the onset of pain can often lead to a ‘downward spiral’ of social isolation and depression, resulting in adverse outcomes for the health of older adults,” wrote lead author Shannon Ang, a doctoral candidate at the U-M Department of Sociology and Institute for Social Research.

“Online social participation serves as a way to possibly arrest the development of pain toward depression through this pathway, by ensuring that older adults remain socially connected despite the presence of pain.”

Social media may also preserve cognitive function and psychological well-being in the elderly, researchers said. The findings are significant in an aging society where social isolation and loneliness are key determinants of well-being.

"Our results may be possibly extended to other forms of conditions (e.g., chronic illnesses, functional limitations) that, like pain, also restrict physical activity outside of the home," Ang said.

The survey data did not identify what types of social media – such as Facebook or Twitter – were more effective in warding off depression and social isolation.

The study was published in the Journals of Gerontology.

Pain Researchers Say Let Sleeping Dogs Lie

By Pat Anson, PNN Editor

Most people with chronic pain recognize the importance of good sleeping habits. A night spent tossing and turning can mean a day full of aches and pains.

For that reason, dog lovers are often told they shouldn’t sleep with their pet. One survey of pet owners found that over half said their dogs tend to wake them at least once during the night. Sleeping with a pet can also be unsanitary and lead to behavioral problems.   

"Typically, people who have pain also have a lot of sleep problems, so usually if they ask their healthcare provider about a pet, they're told to get the pet out of the bedroom. But that standard advice can actually be damaging," says Cary Brown, PhD, a Professor of Rehabilitation Medicine at the University of Alberta.

Brown is co-author of a small study, published in the journal of Social Sciences, in which seven chronic pain patients who slept with their dogs were asked about their pets’ impact on their sleep. Brown said the response was "overwhelmingly positive."

"They liked the physical contact with their dogs—cuddling before bed, and how it distracted them from feeling anxious about being alone at night. They felt more relaxed and safer, so they weren't anxious as they were trying to sleep," said Brown.

"A sense of relaxation and caring are emotions that release positive hormones in our bodies that will help us sleep better."

Having our pets sleep with us can also help ward off loneliness. A dog can take on a significant role for the chronically ill when friends drift away and social circles shrink.

“I’ve got my buddy and I’ve got my companion hanging out with me and I don’t get that loneliness,” one patient said.

“I always have got somebody to cuddle and make me feel loved when I am lonely and in pain and when I am trying to sleep,” said another.

Researchers say doctors need to have deeper conversations with their patients before suggesting that a pet sleep somewhere else.

"When you ask people to remove an animal they are in the habit of co-sleeping with, it could have consequences the health-care provider hasn't considered," Brown said. "For some people with chronic pain, their relationship with their pet could be the only one they have and the comfort that dog or cat produces would be lost."

For some patients, it’s also a reciprocal relationship. They try to help their dogs sleep and comfort them when they have pain.

“She [the dog] has days when she experiences lots of pain, I make myself get down on the floor at her level …. I will sit with her and talk with her and very softly, very calmly, I make a point of massaging her ever so gently,” one woman said. “I find this brings down her heart rate, she’s not in pain, the pain is starting to go down. I can physically see the changes in her and eventually she nods off to sleep.”

Although dogs have been living with people for thousands of years – and often sleeping with them – surprisingly little is known about the emotional and physical benefits of sharing a bed.

“This small study shines a light on this important and yet neglected area of research. It reveals that for these participants their dog appears to enhance their sleep in many ways. Further research is warranted to explore more fully the ways in which pet dogs influence sleep for people with chronic pain,” said Brown.

A Pained Life: Torn Between Hope and Fear

By Carol Levy, PNN Columnist

Tonight, I feel like the character Pushmi-pullyu from Doctor Dolittle. You know, the animal that has a head at both ends; one head pulling to go to the right, the other head raring to go to the left.

I’m also feeling torn between hope and fear.

Although I have trigeminal neuralgia, which is not a headache, I am going to be admitted tomorrow to the headache inpatient unit at one of the city hospitals.

The treatment I will receive is a 24-hour a day IV lidocaine drip, for 4 to 5 days.

Many years ago, I had lidocaine infusions but they were for only 3 to 4 hours each time. I tried it a few times, a few weeks apart, but there was never any benefit. On the upside, there were also no side effects.

“doctor dolittle”

As I read the information online about getting lidocaine for a protracted period, I am getting nervous. Hallucinations? Uh oh. I don't think so. That scares me.

I already know about the potential heart risks. The doctor told me I will have to be tethered to a heart monitor the whole time as a precaution. A sudden drop or increase in blood pressure, unconsciousness and even seizures are possible.

I did not know about the potential for deep vein blood clots until I read the information the clinic sent me. I will have to wear anti-clot stockings the whole time.

There is a list of other “moderate” and “mild” side effects: a metallic taste, tinnitus (ringing in the ears), lightheadedness, agitation, drowsiness, problems focusing, slurred speech, and numbness of the mouth and tongue.

The more serious side effects worry me. Nothing happened when I tried lidocaine the other times, but maybe having it 24 hours a day for a few days in a row vs. 3 to 4 hours every few days makes a difference.

That’s where the Pushmi-pullyu comes from. I do not know if I want to do this.

This will be the first time in the last 13 hospitalizations where I will not be going in for brain surgery to treat my trigeminal neuralgia. I have to admit, there is probably an unconscious aspect of feeling as though I am allowing myself to do one more potentially really dangerous procedure, like another surgery, and I am putting that feeling of danger on the lidocaine.

On the other hand, the reason to go ahead is pure and simple. Bathing the nerves in anesthetic for 72 hours, maybe slightly longer, makes sense to me. The nerves will be numbed or at least calmed down. How can that not work?

My bags are packed. I'm ready to go.  So once again, hope wins out over fear.

Is that a good thing or bad? I won't know for a few days, but I wonder if instead of Pushmi-pullyu for those of us in pain, it should be Fearmi-hopeyu -- with the “hopeyu” being the stronger of the two.

(10/23/18 update: Carol reports the lidocaine infusion did relieve her pain for a while, but by the 3rd day, “I had some bad reactions that altered my reality perception, not what I would think of as hallucinatory but close cousin so we had to stop it.” Carol says she is very disappointed by the outcome, but it was “definitely worth the trying. And thank you to all who asked.”)

Carol Jay Levy has lived with trigeminal neuralgia, a chronic facial pain disorder, for over 30 years. She is the author of “A Pained Life, A Chronic Pain Journey.” 

Carol is the moderator of the Facebook support group “Women in Pain Awareness.” Her blog “The Pained Life” can be found here.

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

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.   

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?

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.

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.

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.

“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.

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.

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, PNN 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.

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.

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 Control, Hanscom 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.

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.”