‘Chili Pepper’ Patch Works Better Than Lyrica

By Pat Anson, Editor

A skin patch containing a synthetic substance found in chili peppers works better than pregabalin in treating patients with neuropathic pain, according to the results of a new study conducted in Europe.

Pregabalin is the generic name for Lyrica, a medication made by Pfizer that is widely prescribed for neuropathy, fibromyalgia and other chronic pain conditions.

Nearly 660 adults with moderate to serve peripheral neuropathic pain (PPN) caused by shingles were randomly assigned to groups receiving either a single treatment with the Qutenza patch or a daily dose of pregabalin.

The 8% capsaicin patch uses a synthetic form of capsaicin, the substance that gives chili peppers their heat, to dull pain-sensing nerves in the skin.

By the 8th week of the study, a little over half of the patients in both groups had achieved pain relief of at least 30 percent. However, the median time to pain relief in the capsaicin group was 7.5 days, compared to 36 days in the pregabalin group. Those who used the Qutenza patch were also more satisfied with their treatment and had fewer side effects.

The study, which is published in the European Journal of Pain, was funded by Astellas Pharma Europe Ltd., which makes the Qutenza patch.

"This is an important and well-conducted study that was designed to mimic everyday practice, allowing those patients randomised to the pregabalin arm to be individually titrated to the optimal tolerated dose,” said lead investigator Maija Haanpää, a professor in the Department of Neurosurgery at Helsinki University in Finland. “We found that topical treatment with the capsaicin 8% patch was non-inferior to the current standard of care. This means that there is now another treatment option for people with peripheral neuropathic pain, especially those patients who are very sensitive to the side effects of systemic medication or for those who do not wish to take tablets every day."

Until now, no head-to-head clinical trials have directly compared the capsaicin patch to pregabalin or other treatments for PNP.

"There is a need to tailor treatment to individual patients and these data show that the capsaicin 8% patch is an efficacious agent to manage patients with peripheral neuropathic pain," said Dr. Andreas Karas, Senior Director, Medical Affairs for Astellas Pharma.

In September of this year, the European Commission approved a label extension for Qutenza to include diabetic patients with neuropathic pain. In the United States, Qutenza has only been approved by the FDA for the management of neuropathic pain associated with postherpetic neuralgia.

Neuropathic pain is characterized by tingling pain that develops as a result of nerve damage caused by conditions such as shingles, diabetes, amputation, inflammation, and cancer. About 8% of adults worldwide suffer from neuropathy. Many drugs used to treat neuropathic pain, such as Neurontin and Lyrica, often don’t work or have unpleasant side effects. Common side effects of Lyrica are dizziness, nausea, headache, weight gain and fatigue.

In addition to neuropathic pain, Lyrica is approved by the FDA to treat chronic pain associated with fibromyalgia, epilepsy, shingles, diabetic peripheral neuropathy, and spinal cord injury. The drug is also prescribed “off label” to treat lumbar spinal stenosis, the most common type of lower back pain in older adults.

Lyrica is Pfizer’s top selling drug with annual worldwide sales of over $5 billion.

Are Opioids or Economics Killing White Americans?

By Pat Anson, Editor

Opinions are all over the map about a recent study by two Princeton University researchers, who estimate that nearly half a million white Americans died in the last 15 years due to a quiet epidemic of pain, suicide, alcohol abuse and opioid overdoses.

The husband and wife research team of Angus Deaton and Anne Case were careful not to point a finger at any one cause, but speculated that financial stress caused by unemployment and stagnant incomes may be behind the rising mortality of middle-aged whites. The deaths were concentrated in baby boomers with a high school education or less.

But some were quick to blame the “opioid epidemic.”

“An opioid overdose epidemic is at the heart of this rise in white middle-age mortality,” wrote psychiatrist Richard Friedman, MD, in an editorial that appeared in the New York Times under the headline “How Doctors Helped Drive the Addiction Crisis.”

“Driving this opioid epidemic, in large part, is a disturbing change in the attitude within the medical profession about the use of these drugs to treat pain,” said Friedman. “It is physicians who, in large part, unleashed the current opioid epidemic with their promiscuous use of these drugs; we have a large responsibility to end it.”

And what should doctors do to end the epidemic?

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Friedman said there was “strong evidence” that Motrin, Tylenol and other nonsteroidal anti-inflammatory drugs (NSAIDS) were “safer and more effective for many painful conditions than opioid painkillers.”

The Fresno Bee took a more nuanced view of what it called “the epidemic of pain and heartbreak.”

“If ever a set of numbers cried out for deeper examination, it is this one. Human frailty may be epidemic, but surely it is also no surprise that a generation raised with the expectation of a secure future might sink into depression, hostility, illness, anguish and rage when that future fails to transpire,” The Bee said in an editorial. “Whether the solution is better jobs, cheaper schools, more mental health care or less reliance on painkillers, the distress of America’s white working class has become a public health crisis.”

“White Americans who used to be able to support a family are now struggling even in dual income households, and there's a corresponding loss in stature and self-esteem. They are turning to prescription opioids in greater numbers than minorities,” said the Baltimore Sun. “The transition to a 21st (century) economy is literally killing some people, and the United States can ill afford to ignore this disturbing development.”

Overseas news outlets also tended to blame the rising death rate on a “ruthless economy.”

“These people are dying because history has unexpectedly thrown them on the scrapheap,” said The Guardian. “White baby boomers had high expectations of the future, yet many of them have lived to discover that they will be worse off than their parents.”

“(The) findings should awaken Americans to the price we pay for pursuing economic policies that enrich the few at the expense of the many,” said David Cay Johnston in a column for Al Jezeera America. “The harsh reality is that our economy is in many ways stuck in 1998 and that for poorly educated Americans, the economy has become a living nightmare with no expectation of a brighter tomorrow. The rise in drug and alcohol poisonings as well as the rising tide of suicides should not surprise. But these trends should disturb.”

What do you think? Is the economy to blame for the increasing number of deaths? Or is it opioids?

Power of Pain: NERVEmber

By Barby Ingle, Columnist  

In a few short days Nerve Pain Awareness month begins – a global movement known in the pain community as NERVEmber.

I began the NERVEmber project in 2009 as a way to bring more attention to chronic nerve pain conditions such as Reflex Sympathetic Dystrophy (RSD/CRPS) and diabetic neuropathy. The term NERVEmber is derived from the burning pain people with neuropathy feel, combined with the month of November. 

The Power of Pain Foundation hosts the official NERVEmber project events each year. Since its inception, tens of thousands of nerve pain patients and organizations have signed on to help promote NERVEmber and bring awareness to the 150 plus conditions that have nerve pain as a symptom.  

The color orange is the international color for chronic pain awareness, which also fits right in with the fall colors we typically see.

Our largest spotlight throughout the month shines on RSD, which is one of the most painful conditions known to mankind. Yet, like many chronic pain conditions, RSD is misunderstood, mistreated and often misdiagnosed. 

Each day during the month of NERVEmber the Power of Pain Foundation will present an awareness task that we can all participate in. This year we are also giving away over $1,000 in prizes -- available to anyone who registers to participate and uses special hashtags on social media, completes daily tasks, and hosts or attends an event. The more you participate in official NERVEmber events, the more chances you have to win!

You can bring more awareness to conditions like RSD, CRPS and diabetes by posting every day in NERVEmber using social media tags on your posts such as @powerofpain and #PaintTheWorldOrange. Using these tags will earn participants chances to win some great prizes.

The Power of Pain Foundation and the #NERVEmber project is also supporting the #CRPSdayofaction, #RSDdayofaction, @theproject3x5’s, #OrangeInitiative,  #ColorTheWorldOrange, and #ColourTheWorldOrange. 

Official events include tasks shared on social media, wearing t-shirts, Paint the World Orange, and educational series.

The daily calendar of events are available here on the NERVEmber webpage.

One of our newest additions to the project is #painPOP. We are asking people to get involved by popping a balloon and challenging others to do the same or make a donation to help the Power of Pain Foundation continue our education, awareness and access to care programs.

We are asking participants to text, post or say something similar to, “I have the NERVE to be HEARD!"

We will also be posting educational videos on YouTube and our website. Watching videos and commenting on them gives participants more ways to win great prizes. For #PaintTheWorldOrange, we ask participants to post their #NERVEmber pictures on social media and to share your pics as you #PaintTheWorldOrange. Be sure to hashtag it #NERVEmber #PaintTheWorldOrange to increase awareness and your chances to win POP prizes.

Participants are also invited to create graphics of their own using #NERVEmber and #PaintTheWorldOrange. Don’t forget to WEAR ORANGE all month long! You can upload your orange photos to help us paint the world.

Tens of thousands have participated in past years from around the world and we are expecting even more this year. Don’t miss out on being part of a movement to make a difference.

For more information on NERVEmber visit http://powerofpain.org/nervember

Barby Ingle suffers from Reflex Sympathetic Dystrophy (RSD) and endometriosis. Barby is a chronic pain educator, patient advocate, and president of the Power of 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.

Sunlight May Delay Onset of Multiple Sclerosis

By Pat Anson, Editor

Exposure to sunlight may elevate your risk of sunburn, skin cancer and other health problems, but it appears to have a beneficial effect in delaying the onset of multiple sclerosis (MS).

Danish researchers found that MS patients who spent time in the sun every day during the summer as teenagers developed the disease later in life than those who spent their summers indoors. Their study, which was published in the online issue of Neurology, also found that people who were overweight at age 20 developed MS earlier.

"The factors that lead to developing MS are complex and we are still working to understand them all, but several studies have shown that vitamin D and sun exposure may have a protective effect on developing the disease," said study author Julie Hejgaard Laursen, MD, of Copenhagen University Hospital in Denmark. "This study suggests that sun exposure during the teenage years may even affect the age at onset of the disease."

MS is a chronic and incurable disease which attacks the body’s central nervous system, causing numbness in the limbs, difficulty walking, paralysis, loss of vision, fatigue and pain.

Ultraviolet rays (UVB) in sunlight are a principal source of Vitamin D, which has a wide range of positive health effects, such as strengthening bones and inhibiting the growth of some cancers.

In the Danish study, over 1,100 people with MS filled out questionnaires and gave blood samples. They were put into two groups based on their sun habits during their teenage years: those who spent time in the sun every day and those who did not. They were also asked about their use of vitamin D supplements during their teenage years and how much fatty fish they ate at age 20.

The people who spent time in the sun every day had an average onset of MS that was nearly two years later than those who did not spend time in the sun. On average, they developed MS at age 33, compared to 31 for those who were not in the sun every day.

"It appears that both UVB rays from sunlight and vitamin D could be associated with a delayed onset of MS," Laursen said. "However, it's possible that other outdoor factors play a role, and these still have to be identified."

Those who were overweight at age 20 developed MS about 1.6 years earlier than those of average weight and 3.1 years earlier than those who were underweight.

Previous studies have shown a relationship between MS and childhood obesity. Obese people are also known to have lower blood levels of vitamin D.

"The relationship between weight and MS might be explained by a vitamin D deficiency, but there's not enough direct evidence to establish this yet," Laursen said.

"A limitation of the study is the risk of recall bias because participants were asked to remember their sun, eating and supplement habits from years before," Laursen said. "In particular, someone with a long history of MS and onset of the disease at an early age, may wrongly recall a poor sun exposure. Additionally, only Danish patients were included into the study, so there should be caution when extending the results to different ethnic groups living in different geographic locations."

New Wearable Devices for Chronic Pain

By Pat Anson, Editor

With opioid pain medications becoming harder to get and many patients looking for safer alternatives with fewer side effects, a growing number of companies are offering wearable “electrotherapy” devices for pain relief.

There’s the Cefaly headband for migraines, ActiPatch for sore muscles, AcuKnee for osteoarthritis, and the Quell nerve stimulator, which is designed to treat a range of chronic pain conditions. All are part of a fast growing $2.8 billion market for wearable medical devices.

“There’s a big problem brewing on the horizon. And that is the pain medications are being removed from the market, slowly but surely,” says Phillip Muccio, President and founder of Axiobionics, which has been making customized electrotherapy devices for 20 years.

“Electrical stimulation has a way of reaching into the body and interacting and coordinating what happens to the body. That’s why it a fascinating area of medicine because not a lot of things will do that, especially non-invasively and non-pharmacologically.”

Most of the new devices use a form of electrical stimulation to block or mask pain signals – a technique developed decades ago known as Transcutaneous Electric Nerve Stimulation (TENS).

Unlike the old TENS units, which are typically used for about 30 minutes, wearable devices are designed to be worn for several hours at a time or even while sleeping.

image courtesy of axiobionics

image courtesy of axiobionics

“TENS is like a short acting opioid. It’s basically only effective when it’s on,” said Shai Gozani, MD, President and CEO of Neurometrix. “If you’re going to deal with chronic pain, you have to have a wearable, chronically usable device, because pain can be two hours a day or it could be 24 hours a day. TENS devices historically haven’t been designed at all for wear-ability or continuous use.”

Neurometrix recently introduced Quell, an electrotherapy device that Gozani compares to a spinal cord stimulator. But instead of being surgically implanted near the spine like a stimulator, Quell is worn externally on the upper calf below the knee.

image courtesy of neurometrix

image courtesy of neurometrix

“We really look at spinal cord stimulation as the model. We’re trying to make that available but in a non-invasive, wearable way -- versus TENS devices which are really intended for local muscle stimulation. We don’t stimulate the muscles, we stimulate the nerve alone,” Gozani told Pain News Network.

“The upper calf has a lot of nerves. It’s comfortable. It’s discrete. So it meets the requirement to have a large segment of nerves to stimulate, but it’s also highly usable from a wear-ability perspective.”

A small study recently conducted by Neurometrix found that over 80% of Quell users had a significant reduction in pain and two-thirds were able to reduce the amount of pain medication they were taking.  Participants in the study had several different types of of chronic pain, including fibromyalgia, sciatica, neuropathy and arthritis.

When it comes to clinical studies, medical device makers have a clear advantage over pharmaceutical companies, which often have to spend years and tens of millions of dollars proving the safety and effectiveness of their drugs before they’re approved by the Food and Drug Administration. Device makers are held to a lower regulatory standard.

“Devices are approved by FDA basically for safety and not necessarily for efficacy. It’s a lot easier to demonstrate that with a device than if you have to demonstrate a new drug. You basically run one study or two and show that nobody got electrocuted by a TENS unit and you’re good to go,” said Bob Twillman, PhD, Executive Director of the American Academy of Pain Management.

Device makers can even get fast track approval from the FDA without any clinical studies -- if they say a new device is substantially equivalent to an older device already on the market.  Quell, for example, was given clearance by the FDA because of its similarity to Sensus, another Neurometrix device that's worn below the knee for pain relief.

A significant disadvantage for device makers is that most are not covered by public or private health insurers – meaning patients have to pay for them out of pocket. Three years ago, Medicare stopped covering TENS for low back pain, saying the technology was “not reasonable and necessary.”

The lack of reimbursement also makes many doctors unwilling to prescribe wearable devices and unfamiliar with the technology behind them, which stifles innovation.  For that reason, Neurometrix took an unconventional path and made Quell available without a prescription – bypassing insurers and doctors so it could market directly to consumers for $249 a unit.

“We thought it was imperative to get it over the counter. We wanted to make sure it was accessible to patients," said Gozani. "Wear-ability changes everything. Wear-ability is the game changer in terms of optimizing pain relief. I think it's huge."

Smoking Accelerates Multiple Sclerosis

By Pat Anson, Editor

Smoking is never a good idea for anyone – especially people in chronic pain -- but according to a new study it is particularly bad for multiple sclerosis patients, both before and after diagnosis.

Cigarette smoking is already a known risk factor for developing multiple sclerosis (MS), but in a first of its kind study published in JAMA Neurology, Swedish researchers found that continuing to smoke after diagnosis significantly accelerates progression of the disease.

MS is a chronic and incurable disease which attacks the body’s central nervous system, causing numbness in the limbs, difficulty walking, paralysis, loss of vision, fatigue and pain. Symptoms begin with a series of irregular relapses, and after about 20 years MS worsens into a secondary progressive (SP) stage of the disease.

In a study of over 700 MS patients who continued to smoke after their diagnosis, researchers found that each additional year of smoking accelerated the time to SP conversion by 4.7 percent.  

Looking at it another way, the study found that patients who continued to smoke converted to SP faster (at an average age of 48) than those who quit smoking (at age 56).

“This study demonstrates that smoking after MS diagnosis has a negative impact on the progression of the disease, whereas reduced smoking may improve patient quality of life, with more years before the development of SP disease,” said lead author Jan Hillert, MD, Department of Clinical Neuroscience, Karolinska University Hospital Solna in Stockholm.

“Evidence clearly supports advising patients with MS who smoke to quit. Health care services for patients with MS should be organized to support such a lifestyle change.”

Getting MS patients to quit is important not only for patients, but for society as a whole because of the high cost of treating MS. Disease modifying drugs such as fingolimod and natalizumab, cost about $30,000 per year and are not always effective.

“This study adds to the important research demonstrating that smoking is an important modifiable risk factor in MS. Most importantly, it provides the first evidence, to our knowledge, that quitting smoking appears to delay onset of secondary progressive MS and provide protective benefit,”  said Myla Goldman, MD, of the University of Virginia, and Olaf Stüve, MD, of the University of Texas Southwestern Medical Center in an accompanying editorial in JAMA Neurology.

Previous studies have found that smoking increases your chances of having several types of chronic pain conditions.

A study of over 6,000 Kentucky women found that those who smoked had a greater chance of having fibromyalgia, sciatica, chronic neck pain, chronic back pain and joint pain than non-smokers. Women in the study who smoked daily more than doubled their odds of having chronic pain.

A large study in Norway found that smokers and former smokers were more sensitive to pain than non-smokers. Smokers had the lowest tolerance to pain, while men and women who had never smoked had the highest pain tolerance.

Quell Device Relieves Variety of Pain Conditions

By Pat Anson, Editor

A new medical device that uses electrical nerve stimulation was effective in managing chronic pain in patients suffering from arthritis, neuropathy, fibromyalgia and other conditions, according to a small clinical study conducted by NeuroMetrix (NASDAQ: NURO), the device’s manufacturer.

Pain News Network recently featured the Quell Wearable Pain Relief device in a column by J.W. Kain, who reported that Quell “worked brilliantly” in relieving her chronic neck and back pain.

Eighty eight people were enrolled in a 60-day trial of Quell. All had chronic pain for at least year and nearly a quarter had more than 15 years of pain. Participants had “complex medical histories” with arthritis (61%), diabetic nerve pain (40%), sciatica (27%), and fibromyalgia (26%) as the most common conditions.

Over 80 percent of the participants said Quell relieved their chronic pain and improved their overall health. The largest measured changes were in pain relief, along with improved sleep, general activity, and walking ability.

Over two-thirds of the patients said Quell also reduced the amount of pain medication they were taking

image courtesy of neurometrix

image courtesy of neurometrix

"We are pleased with these results. They represent the first formal evaluation of self-administered wearable intensive nerve stimulation. Quell provided substantial pain relief and improvement in quality of life measures,” said Shai N. Gozani, MD, President and CEO of NeuroMetrix.

“We were not surprised that two-thirds of the subjects reduced their use of pain medications, as we have consistently received this anecdotal feedback from Quell users over the past several months.”

Quell is available over-the-counter and does not require a prescription. It relieves pain by using electric stimulation to “mask” pain signals before they reach brain, much like a TENS unit.  The device, which costs $249, is lightweight and designed to be worn over the upper calf during the day or night.

The marketing of Quell for the treatment of chronic pain was approved by the Food and Drug Administration in 2014, but NeuroMatrix did not begin shipping the device to healthcare providers until this summer. It is also available through the company’s website.

A study abstract, “Treatment of Chronic Pain with a Novel Wearable Transcutaneous Electrical Nerve Stimulator,” has been accepted for poster presentation at the annual PAINWeek conference next month in Las Vegas.