Can Alcohol Help Treat Chronic Pain?

By Pat Anson, Editor

Treating chronic pain with a glass of wine or beer may not sound like a good idea, but an intriguing new study in the U.K. found that alcohol consumption is associated with lower levels of disability in pain patients.

Researchers at the University of Aberdeen in Scotland surveyed over 2,200 people with fibromyalgia and other chronic widespread pain conditions about their alcohol consumption. About a quarter of the respondents were teetotalers, the rest drank rarely, moderately or heavily – the latter consuming as much as 21 to 35 “units” of alcohol a week.

A “unit” was defined as 10 ounces of beer, a small glass of wine or a single beverage with hard liquor – meaning the heaviest drinkers averaged three to five drinks a day.

Drinkers overall reported less disability than people who never drank alcohol, but it was the heaviest drinkers who reported the least disability. They were 67% less likely to experience disability than the teetotalers.

“As well as an association between alcohol consumption and lower levels of disability in pain patients, we also found that the population prevalence of chronic pain was lower in drinkers than in non-drinkers. It’s clear that non-drinkers are more likely to have pain, and more likely to be disabled by it if they have it, compared to drinkers,” said Marcus Beasley, study coordinator at the University of Aberdeen.

Does alcohol act as an analgesic and simply dull pain sensations? Or does it treat and help prevent chronic pain? The researchers are cautious about drawing any conclusions.

“This study has demonstrated strong associations between level of alcohol consumption and CWP (chronic widespread pain). However the available evidence does not allow us to conclude that the association is causal. The strength of the associations means that specific studies to examine this potential relationship are warranted,” wrote Professor Gary Macfarlane, lead author of the study published in the journal Arthritis Care & Research.

“The design of this study cannot tell us whether drinking causes people to have less problems with pain, or if people who have pain make the choice not to drink. In any case people that drink are very different on a wide range of health measures than those that do not drink,” said Beasley.

“For primary care practitioners these findings mean that the fact a patient does not drink could be considered a potential marker for having other health problems, including with chronic pain. Otherwise, the advice that practitioners give to patients should remain the same – drink less if possible, and if consuming alcohol then do so within recommended safe limits.”

Previous research has linked moderate alcohol consumption with a lower risk of heart disease, stroke and diabetes. But drinking too much alcohol can lead to a variety of serious health problems.

How much is too much?

According to the Mayo Clinic, moderate alcohol consumption for healthy adults means up to one drink a day for women of all ages and men older than age 65, and up to two drinks a day for men age 65 and younger.

The UK study isn’t the first to find an association between alcohol and a reduced risk of chronic pain. A large study conducted in Sweden, published in the British Medical Journal, found that women who had more than three drinks a week had about half the risk of developing rheumatoid arthritis than non-drinkers.

Another study, published in Arthritis Research & Therapy, found that low and moderate drinkers suffering from fibromyalgia had less pain, less fatigue and missed fewer days of work than non-drinkers.

Wear, Tear & Care: The Quell Pain Relief Device

By Jennifer Kain Kilgore, Columnist

When presented with the Quell pain relief device, people make one of two assumptions about me: 1.) I injured my knee, or 2.) I am a paroled felon wearing a very forgiving Velcro GPS.

As I said in my recent guest column, I have made it my mission to test as many pain relief products and therapies as possible. Some of them might be familiar to you; others will be of the “new and bizarre” variety. Whatever they are, I will be your Friendly Neighborhood Guinea Pig and review them for your convenience. I only draw the line at “Made for TV” products that are out to swindle the desperate consumer.

Pain patients are certainly desperate. We have a constant refrain humming through our bodies that plays a different tune for each person. Doctors are the musicians taught to hear those tunes -- but how can they possibly learn all the music? How can they hear your specific song and have the knowledge necessary to fix it?

The problem is that sometimes they cannot. They are deaf to your pain, just like that one whale who sings higher than every other whale -- none of them can hear her.

Thus far, doctors have been unable to hear the song that thrills along my nerve endings. This leaves me with no choice but to fend for myself. I could take the route at which they have hinted: find some street drugs and wait for the undertow to take me (not that this is the problem the media makes it out to be). Or I could travel a different road and at the same time realize that this life of mine includes pain. If I can’t get rid of it, I can at least muffle it.

image courtesy of neurometrix

As I said recently in my blog -- Wear, Tear, & Care -- I have been trying the Quell pain relief device, which is made in the great state of Massachusetts (i.e., my backyard). I have been using it every day for more than a month. Here are my findings:

• It absolutely works. I have been wearing it for 35 days. I assume there was some psychosomatic effect at first because I was so excited to try the device after months of hype. Once the initial thrill wore off, I was left with the knowledge that, yes, I have reduced my number of Motrin from 16 a day to four, give or take. I am still on Cymbalta and Lyrica for pain control and situational depression, though I can now contemplate reducing the Lyrica entirely. Before, that was not even a possibility.
• Wearing any kind of medical device during the summer is difficult. I can make the Stride of Pride and show if off with a skirt or shorts; otherwise I have to find pants under which the device can comfortably fit. This means that a good portion of my wardrobe (leggings, skinny jeans, etc.) is not compatible with the Quell. This is a minor concern.
• The Quell is $249.00. Replacement electrodes cost $30 and last for two weeks. I have worn mine for longer than that because A.) I can, and B.) I’m cheap. The electrodes break down quickly, but as a whole they are more durable than traditional electrodes and do not irritate my skin. With the EMPI device, the electrodes left blisters on my back.
• The iPhone app is quite lovely. It has a countdown clock so you can see how long the therapy has lasted or how far away it is. I have become adept at the internal calculation of 60 minutes on, 60 minutes off.
• Unlike other TENS devices I have tried, the stimulation is not distracting, so wearing it at the office is fine.

This is all well and good. But how does the Quell work?

According to their research paper presented to the FDA, the Quell works not unlike other devices that latch onto a dense cluster of nerves in the upper calf. Generally it is best for lower-body pain (sciatica and the like), diabetic neuropathy, and fibromyalgia. I myself have fibromyalgia-ish symptoms, since my pain radiates all over my body. However, I apparently do not actually have the inflammation that is fibro’s hallmark. Doctors will only commit to “chronic pain syndrome.” Since the device works for me, I can say confidently that it treats more than those three conditions.

The Quell is twice as strong as conventional TENS units, does not irritate the skin like traditional electrodes, is less conspicuous, has a mobile app, and can be worn at night. (They say it can be worn at night; I personally found the stimulation too distracting.) It activates endogenous opioids in the body (natural opioids, to say it in English), a different system than the one on which prescription opiates work.

It is, simply put, a wearable intensive nerve stimulator that follows the Pain Gate Theory: The impulses generated by the Quell block pain signals from reaching the brain. As it was cleared to be sold over-the-counter, it is currently not covered by insurance.

I know you pain patients out there loathe the numbers system (What is your pain on a scale of 1 to 10?). I also despise it; this is the only one that has come close to working for me. That’s why I have created a new system. Instead of assigning an arbitrary number to my pain, I am going to tell you what I can do now that I couldn’t do before.

1. I can cut down my daily over-the-counter medication.

2. I can walk for longer periods of time (36 days ago I could walk about 10 minutes before starting to limp; now I can make it almost 30 minutes).

3. I can sit for longer periods of time during the work day (prior to the Quell I’d last 10 minutes before having to get up and move around; now I can make it to 30 before movement becomes necessary).

4. I can focus better on immediate tasks.

5. I have more energy during the daytime, which makes me more social. I have been hanging out with friends more. However, I still practice the chronic pain version of sundowning in the evenings (i.e., I crash).

6. I have been able to resume my almost-daily yoga practice. I even did a 55-minute video the other day (which was   Aroga Yoga’s yoga class for those with chronic illness).

7. I have been able to resume my aqua aerobics practice two to three times per week.

8. I wear my emergency back brace less frequently.

9. I have fewer flares.

FINAL DIAGNOSIS: The Quell device has worked brilliantly for me. While it doesn’t get rid of all the pain I feel, it dampens enough of it so that I can more fully live my life. I hope that it can bring others as much relief.

Jennifer Kain Kilgore is an attorney in the Greater Boston area who also works as a writer and editor in her spare time.  She has chronic back and neck pain after two car accidents. 

You can read more about J.W. on her blog, Wear, Tear, & Care.  

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.

Cymbalta and Lyrica in Legal Battles

By Pat Anson, Editor

The makers of Cymbalta and Lyrica – two blockbuster drugs widely used to treat fibromyalgia and other chronic pain conditions – face legal battles this summer that could potentially cost the companies billions of dollars.

In London, a court case begins next week on Pfizer’s efforts to keep doctors in the U.K. from prescribing pregabalin – a cheaper generic version of Lyrica.

And in Los Angeles, a federal judge this week ordered Eli Lilly to face claims in lawsuits alleging that the company misled consumers about the side effects of withdrawal from Cymbalta.

Over 5,000 patients have filed suit against Lilly claiming that Cymbalta caused “brain zaps” – electric shocking sensations – as well as nausea, vomiting and insomnia when they stopped taking the drug.  The first two cases will be heard in August.

“The withdrawal symptoms from Cymbalta were hell,” wrote Crystal Lindell, a Pain News Network columnist in a recent article.

“Less than a week after my last pill, I was getting so dizzy that I seriously thought I had a new disease. Then, there was this thing called the brain zaps that I didn’t understand until they happened to me. In short, it literally felt like my brain was being, well, zapped by electricity. There was also nausea and vertigo and just an overall feeling of falling off a skyscraper.” 

Several readers shared their own experiences with Cymbalta.

“My neurologist put me on Cymbalta, I took 2 pills, I thought my head was going to explode,” wrote Judy Dunn.

“I suffered from 6 weeks of vertigo, nausea, dizziness, and MASSIVE headaches,” said Andy, who was prescribed Cymbalta to treat depression. “I will never take Cymbalta again. EVER.”

“While on the drug I did get a better mood and it helped a lot, but it raised my blood pressure and I was shaky and jittery. I also went through the brain ZAPS!!” wrote Candra Clark.

“We believe in our defenses to these claims and we will continue to defend Lilly vigorously,” Scott MacGregor, a Lilly spokesman told Bloomberg Business.

Cymbalta generated annual sales of $5 billion for Lilly until its patent expired in 2013 and cheaper generic versions of Doluxetine became available.

Lyrica Legal Battle

Like Cymbalta, Lyrica wasn’t originally developed to treat pain. It was used as a treatment for anxiety and epilepsy until drug maker Pfizer realized it could also be effective for fibromyalgia and neuropathic pain.

Pfizer’s patent on Lyrica for epilepsy and anxiety expired last year, but its secondary patent for pain is good until July of 2017 – and that is the essence of its legal fight in the U.K.

Rival drug makers started making pregabalin – the generic version of Lyrica – when its original patent expired. But it didn’t take long for doctors to also start prescribing pregabalin for pain.

According to Pharmalot, about 80% of all U.K. patients on pregabalin are using it to treat pain and Pfizer has launched an aggressive campaign to stop that. Last year the company wrote an unusual letter to physician groups in the U.K. warning them that prescribing pregabalin for pain was a violation of its patent.

“Pfizer believes the supply of generic pregabalin for use in the treatment of pain whilst the pain patent remains in force in the U.K. would infringe Pfizer’s patent rights,” the company said in the letter.

The Royal College of Physicians, which represents 29,000 U.K. doctors, responded with a statement of its own.

“Pregabalin is a useful drug for many patients and, given the current financial pressures the NHS (Britain’s National Health Service) is under, it is disappointing that a pharmaceutical company has made a move that will, potentially, prevent some patients from getting access to it,” a spokesman said.

The NHS has since issued guidance to doctors telling them to use the brand name Lyrica when prescribing pregabalin for pain “so far as reasonably possible.” Pfizer is seeking a stronger statement from the British High Court.

Ironically, Pfizer paid $2.3 billion dollars in 2009 to settle criminal and civil charges in the U.S. for the “off-label” marketing of Lyrica and other medications – the very sort of off-label use it is trying to stop in the U.K.

Lyrica remains one of Pfizer’s top selling drugs, generating $5.1 billion in revenue in 2014.  

Chronic Fatigue Patients ‘Disrespected and Rejected’

By Pat Anson, Editor

An independent panel convened by the National Institutes of Health is calling for major changes in the way the healthcare system treats people suffering from chronic fatigue – a complex and poorly understood disorder that affects an estimated one million Americans, most of them women.

Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) is characterized by extreme fatigue, chronic pain, impaired memory, insomnia, and other symptoms that do not improve with rest.  Many of the symptoms overlap with other diseases and disorders -- including fibromyalgia, depression, and inflammation – making a correct diagnosis even more difficult.

There is also a stigma often associated with chronic fatigue.

“Both society and the medical profession have contributed to ME/CFS patients feeling disrespected and rejected. They are often treated with skepticism, uncertainty, and apprehension and labeled as deconditioned or having a primary psychological disorder,” the panel states in its final report.

“ME/CFS patients often make extraordinary efforts at extreme personal and physical costs to find a physician who will correctly diagnose and treat their symptoms while others are treated inappropriately causing additional harm.”

Although the economic burden of chronic fatigue is estimated at between $2 billion and $7 billion annually, the panel said there has been “minimal progress” in improving the state of science for ME/CFS over the last 20 years. There are no pathogens linked to chronic fatigue, no diagnostic tests and no known cures.

"We need to learn more about the cellular and molecular mechanisms of this disease and how immunologic, neurologic, and other factors contribute to ME/CFS," said Carmen Green, MD, the panel’s chair and professor of anesthesiology, obstetrics and gynecology, and health management and policy at the University of Michigan Schools of Medicine and Public Health.

"We need to fund more studies that can be easily reproduced, and we must gain a better understanding of how ME/CFS affects people and their families in terms that are clinically meaningful to them. In addition, we need to have a greater understanding of the impact of ME/CFS across the life span, especially in underserved and vulnerable populations."

What little research that has been done has focused on Caucasian, middle-aged women.  The panel said new studies need to include children, minorities, men, patients living in rural areas, and those who are homebound.

To address these knowledge gaps, the panel is calling for more research and opportunities for new investigators to study ME/CFS. It also called for the creation of a repository of biological samples from chronic fatigue patients (e.g., serum, whole blood, RNA, DNA) to support new studies.

In addition, the panel recommended new educational training courses to help health care providers diagnose and treat ME/CFS.

"ME/CFS exists, and despite the absence of a clear definition, an estimated one million Americans are affected by it," said Green. "In order to develop primary prevention strategies and effective drug treatments, there needs to be a clear understanding of its causes and the populations it affects."

Much of the information gathered by the panel came during a public workshop and public comment period in December of last year. The five member panel, which included Penney Cowan of the American Chronic Pain Association, operated as an independent commission. Its final report is not a policy statement of the NIH or the federal government, and there are no guarantees its recommendations will be funded or acted upon.

Critics Question Oxygen Therapy for Fibromyalgia

By Pat Anson, Editor

Some experts are challenging the findings of a new clinical study that found that hyperbaric oxygen therapy (HBOT) could be used to treat -- and possibly even cure -- fibromyalgia.

Israeli researchers gave HBOT therapy to dozens of women suffering from fibromyalgia and found there was a significant improvement in their pain and other symptoms. The women were put in pressurized air chambers and breathed pure oxygen for 90 minutes, five times a week for two months.

Researchers say brain scans of the women before and after HBOT proved their theory that additional oxygen alters brain pathology and "repairs" parts of the brain overly sensitized by chronic pain. 

"Brain pathology? This is speculation being presented as established knowledge," said John Quintner, MD, an Australian rheumatologist who maintains that fibromyalgia is not a disease, but a "symptom cluster" that could have many different causes.

tHE INTERIOR OF A HYPERBARIC CHAMBER. COURTESY OF Sagol Center for Hyperbaric Medicine and Research

Fibromyalgia is a poorly understood disorder that is characterized by deep tissue pain, headaches, fatigue, depression and insomnia. The cause is unknown.

"This clinical trial is using a methodology that is predicated upon fibromyalgia being a distinct medical condition," said Quintner, telling Pain News Network that the study proved little, but was "good news for those who manufacture portable HBOT units." 

Researchers at the Sagol Center for Hyperbaric Medicine and Research at the Assaf Harofeh Medical Center and Tel Aviv University were studying the use of HBOT on stroke and concussion patients when they realized that oxygen therapy might also change the neural activity of patients with fibromyalgia.

"Patients who had fibromyalgia in addition to their post-concussion symptoms had complete resolution of the symptoms," said Shai Efrati, MD,  lead author of the study that is published online in PLoS ONE. 

Efrati said some patients will require follow-up sessions of HBOT and some won't need to.

"We have learned, for example, that when fibromyalgia is triggered by traumatic brain injury, we can expect complete resolution without any need for further treatment. However, when the trigger is attributed to other causes, such as fever-related diseases, patients will probably need periodic maintenance therapy."

HBOT puts more oxygen into the bloodstream, which delivers it to the brain. Efrati's earlier studies found that HBOT induces neuroplasticity, which leads to repair of chronically impaired brain functions. Most of the women who participated in the new study had fibromyalgia that the researchers believe was triggered by brain trauma.

DR. SHAI EFRATI

"Symptoms in about 70 percent of the women who took part have to do with the interpretation of pain in their brains," said Eshel Ben-Jacob, a study co-author who is an adjunct professor of biosciences at Rice University. "They're the ones who showed the most improvement with hyperbaric oxygen treatment. We found significant changes in their brain activity.

"Most people have never heard of fibromyalgia. And many who have, including some medical doctors, don't admit that this is a real disorder. I learned from my MD friends that this is not the only case in which disorders that target mainly women raise skepticism in the medical community as to whether they're real or not."

HBOT Claims Called "Crazy" 

One of those skeptics is Fred Wolfe, MD, a prominent fibromyalgia researcher who says the Israeli study lacks proper controls used in most clinical studies -- such as patients being "blinded" to whether they are receiving treatment or a placebo.  

"The fibromyalgia study world is filed with positive studies based on unacceptable controls," said Wolfe. "While I don't know enough about this treatment to be sure, I would tend to think the symptomatic improvement could be based on control and blinding problems. It is possible that the demonstrated effect on the brain of oxygen is separate from the effect of symptoms." 

Wolfe is particularly troubled by a recommendation at the end of the study that fibromyalgia patients should undergo HBOT therapy now, "rather than wait until future studies are completed.”  

"I could only characterize (that) as crazy. Crazy because of the money it would cost and crazy because it posits fibromyalgia as brain disease. FM is not a disease and there is a difference between mechanism and causes. One needs some replication before jumping in," said Wolfe in an email to Pain News Network. 

Many fibromyalgia patients are ready to jump in, based on the comments from readers to our first report about the Israeli study.

"Where do you find studies like this to volunteer? I would so do this," wrote one fibromyalgia sufferer.

"I would so try this. I often feel like I'm not getting enough oxygen," said another.

"Sign me up, please," a woman wrote.

"Is this available in Tucson or Phoenix, Arizona?" asked another woman.

Many fibromyalgia sufferers are desperate for any kind of treatment that would provide relief, much less a cure. In the Israeli study, several patients either drastically reduced or eliminated their use of pain medications.

"The results are of significant importance since, unlike the current treatments offered for fibromyalgia patients, HBOT is not aiming for just symptomatic improvement," said Efrati. "HBOT is aiming for the actual cause -- the brain pathology responsible for the syndrome. It means that brain repair, including even neuronal regeneration, is possible even for chronic, long-lasting pain syndromes, and we can and should aim for that in any future treatment development."

John Quintner is not convinced.

"I have thought long and hard about this issue and have come to the conclusion that we have been dealing with a 'symptom cluster' rather than with a syndrome," he said. "According to my understanding, fibromyalgia is best explained as an  'idiom of human distress' and, as such, is outside the purview of the biomedical model." 

Can Oxygen Therapy Treat Fibromyalgia?

By Pat Anson, Editor

Hyperbaric oxygen therapy – also known as HBOT – has been used for decades to treat infections, severe burns, carbon monoxide poisoning, even scuba divers recovering from decompression sickness.

Patients undergoing HBOT are put in a pressurized room or tube. The higher air pressure allows lungs to gather more oxygen than they would normally – helping the body to heal faster.

Promising new research out of Israel suggests that HBOT can also be used to treat fibromyalgia patients by causing neuroplasticity – a “re-wiring” of the brain that can change neural activity in areas overly sensitized by chronic pain. The study has been published in the journal PLoS ONE.

“This study provides evidence that HBOT can improve quality of life and well-being of many FMS (fibromyalgia) patients. It shows for the first time that HBOT can induce neuroplasticity and significantly rectify brain activity in pain related areas of FMS patients,” wrote lead author Shai Afrati, MD, of the Institute of Hyperbaric Medicine, Assaf Harofeh Medical Center.

file photo of a woman getting hyperbaric oxygen therapy

Fibromyalgia is a poorly understood disorder that is characterized by deep tissue pain, headaches, fatigue, depression and insomnia. The cause is unknown and there is no cure.

Afrati, who has also studied oxygen therapy on stroke and concussion victims, enrolled 60 female fibromyalgia patients in his latest study. For five days each week they were given 90 minutes of HBOT with oxygen enriched air.

“It is plausible that increasing oxygen concentration by HBOT can change the brain metabolism and glial function to rectify the FMS-associated brain abnormal activity. It has already been demonstrated that exposure to hyperbaric oxygen induces significant anti-inflammatory effect in different conditions and pathologies,” said Afrati.

After two months, brain imaging showed the women had significant changes in neural activity, and they reported less pain and fewer tender points. Several said that they had either reduced or stopped taking pain medication.

However, not everyone could handle being placed in a pressurized air chamber. Five women dropped out of the study, complaining of dizziness, claustrophobia and an inability to adjust to the air pressure.

But Afrati is encouraged by the results.  

“Follow-up studies are needed in order to investigate the durability of the HBOT effects on FMS. It might be that some patients will need more HBOT sessions,” he wrote. “Since there is currently no solution for FMS patients, and since HBOT is obviously leading to significant improvement, it seems reasonable to let FMS patients benefit from HBOT, if possible, now rather than wait until future studies are completed.”

Fibromyalgia Blood Test Gets Insurance Coverage

By Pat Anson, Editor

The founder of a bioresearch company that offers a controversial blood test for fibromyalgia says the test is now covered by Medicare and some private insurers. But questions remain about the viability of the test.  

“Insurance has really been the big issue for us. That was the hump we really needed to get over,” said Bruce Gillis, MD, the founder and CEO of EpicGenetics in Santa Monica, CA.

“We are a Medicare approved laboratory. It covers 100% of the test. We are getting private insurance companies that are reimbursing for the test. And we have gotten most Blue Cross Blue Shield agencies to pay for the test.”

“We are a Medicare approved laboratory. It covers 100% of the test. We are getting private insurance companies that are reimbursing for the test. And we have gotten most Blue Cross Blue Shield agencies to pay for the test.”

EpicGenetics introduced the FM/a test in 2013, calling it the first definitive blood test for fibromyalgia, a poorly understood disorder that is characterized by deep tissue pain, fatigue, depression and insomnia. The test costs $775 and results are usually available in about a week.

Gillis told Pain News Network that with insurance coverage now available he expects more people to take the test. He projects his lab to analyze its 5,000th FM/a test by the end of the year.

IMAGE COURTESY OF EPICGENETICS

The test looks for protein molecules in the blood called chemokines and cytokines, which are produced by white blood cells. Fibromyalgia patients have fewer chemokines and cytokines in their blood than healthy people, according to Gillis, and have weaker immune systems as a result.

But critics have contended that the same immune system biomarkers can be found in people with other illnesses, such as rheumatoid arthritis, making the FM/a test meaningless.

Two small studies supporting Gillis’ theory have been conducted, both of them financed by EpicGenetics. The most recent study, published in Rheumatology International, compared the blood profiles of 160 patients who had taken the FM/a test to blood from hundreds of lupus and rheumatoid arthritis patients, as well as a control group.

“We were able to demonstrate statistically significant differences in scores comparing patients with FM (fibromyalgia), healthy controls and autoimmune disease,” wrote lead author Daniel Wallace, MD, a rheumatologist at the Cedars-Sinai Medical Center in Los Angeles and a professor at the David Geffen School of Medicine at UCLA who has worked as a consultant for EpicGenetics.

“This cytokine profile test had a 93% sensitivity and an 89.4% specificity for the diagnosis of FM. We also found that these profiles are relatively sensitive and specific for FM compared to SLE (lupus) and RA (rheumatoid arthritis). It remains unclear if these differences are directly related to the pathogenesis of FM.”

Wallace called his research “exploratory” and said further studies are needed to see if other autoimmune diseases can lower levels of chemokines and cytokines in the blood.

But Gillis goes further – saying the study “proved” that the FM/a test works.

“This study analyzed patients with fibromyalgia against patients with rheumatoid arthritis and lupus, the two primary illnesses in rheumatology. And it proved that our biomarkers are indeed distinct for fibromyalgia,” said Gillis.

"Junk Science"

But critics say more proof is needed – not only that the FM/a test works – but that fibromyalgia is a separate and distinct disease.

“The study is interesting but interpretation of their results is still made somewhat difficult by the fact that, as far as we know, fibromyalgia is not a discrete medical condition,” said John Quintner, MD, a rheumatologist in Australia. 

Quintner calls fibromyalgia a “symptom cluster” and says lower levels of chemokines and cytokines could be caused by a number of different disorders that trigger an immune system response. 

“Such conditions might also include major depressive disorder and post-traumatic stress disorder,” Quintner wrote in an email to Pain News Network.

An even bigger skeptic is Fred Wolfe, MD, a prominent researcher and rheumatologist who has called the EpicGenetic studies “junk science.” 

“The (new) study is very, very bad, and does not meet minimal scientific standards. The test is not needed and could not possibly be valid,” said Wolfe, who also considers fibromyalgia more of a symptom than a disease.   

“What you need to do in a study like this is you need to have an unbiased population. And this is by no means an unbiased population. They picked the people. If you’re measuring stress, it’s very easy to pick the patients you want and get the results you want,” Wolfe told Pain News Network.

“Fibromyalgia is an illness that can be found in people with rheumatoid arthritis and lupus. It occurs in about 25% of people with rheumatoid arthritis. It’s sort of like separating anxiety from cancer. A lot of people with cancer have anxiety. And the idea that you could have a test that separates anxiety from cancer is absurd because these conditions can occur together and frequently do.”

Pfizer Funding

Gillis says Wolfe’s views about fibromyalgia may have been influenced by funding he received from Pfizer, a pharmaceutical company that makes Lyrica – an anti-seizure drug that was re-purposed by Pfizer to treat fibromyalgia. Lyrica is Pfizer’s top selling drug with annual worldwide sales of over $5 billion.

According to ProPublica, Wolfe received $200,000 in funding from Pfizer from 2010 to 2013 for research and consulting.

“Our test says that fibromyalgia is an immunologic disorder,” said Gillis. “Why would you take an anti-seizure medicine for an immunologic disorder? Lyrica’s primary indication is for anti-seizure therapy.”

Wolfe says the funding he received from Pfizer was for a rheumatoid arthritis study, not fibromyalgia. As for Lyrica, Wolfe says he doesn’t consider the drug a good treatment for fibromyalgia.  

“I think what Pfizer has done has been very harmful, and I have stated and written this publicly. I was barred from speaking at a meeting some years ago by Pfizer and have continuously refused to cooperate with them,” he said.

Fatigue Often Stops RA Patients from Working

By Pat Anson, Editor

Fatigue and pain are the top reasons rheumatoid arthritis (RA) patients in the U.S. stop working, according to a new survey that found only about a third of RA patients are still employed full-time.

The “RA in America” survey of over 3,500 patients was conducted online by Health Union, a healthcare research and marketing company. It found that RA had a severe impact on patients’ quality of life, employment, and ability to afford treatment.

RA is a chronic and disabling autoimmune disease that causes pain and stiffness in joints. It affects about 1.3 million Americans and about one percent of the global population.

Ninety-four percent of respondents said they cannot do as much as they were able before acquiring the disease. Only 37% said they were still working full time.

Although fatigue is often overlooked as a symptom of RA, it had the greatest impact on the respondents’ ability to work – with 92% reporting they were tired while on the job. Pain, physical limitations, and a lack of understanding by colleagues also presented challenges.

“My biggest complaint is fatigue,” wrote one poster on a Health Union Facebook page.  “I am an invalid due to RA. I am in bed 24/7, I can't even sit up. I sleep a lot, not much else to do, but no matter how much I sleep, when I wake I'm exhausted. It's so crazy. I can sleep for 20 hours, and I'm exhausted the minute I open my eyes.”

“I was forced from my job because of exhaustion,” wrote another woman. “The meds contributed to the sleepiness, so I am careful about which I take. (I have) developed Lupus, OA and several related syndrome in addition to the RA.”

Many people who were surveyed said they were diagnosed with other conditions, including depression and anxiety (39%), high blood pressure (33%), fibromyalgia (32%) and migraine (25%).

Survey respondents also reported they needed help with daily activities, such as cleaning (75%) and other household chores (52%). Over a third (41%) needed assistance from a caregiver, which was typically a spouse, to help manage their RA.

"Many people do not know rheumatoid arthritis is a progressive, autoimmune disease and not the result of aging and wear on the body, like osteoarthritis the most common form of arthritis," said Andrew Lumpe, PhD, an RA patient. "Treatment can help slow the damage, but rheumatoid arthritis frequently alters the lives of both patients and their families."

The survey found some good news to report. Over a third (34%) of respondents said their RA had gone into remission at some point, usually for less than a year. Nearly three-fourths (74%) said the remission occurred after they began taking medication.

About half the survey respondents reported satisfaction with their treatments and only 21% were dissatisfied. Those on biologics, a newer and more expensive medication that can cost over $20,000 a year, had a slightly higher satisfaction rate. Over a third of respondents (38%) have avoided medications because of cost.

"The affordability of effective rheumatoid arthritis treatments is a serious concern," said Mariah Leach, an RA patient. "When you consider the burden this disease places on patients in terms of quality of life and employment, it is clear that supporting these individuals with treatment options can yield many benefits."

UK Research Could Lead to Blood Test for Fibromyalgia

By Pat Anson, Editor

British researchers have launched a genetic study of fibromyalgia patients that they hope could lead to a new blood test to diagnose the disease.

Fibromyalgia is a poorly understood disorder characterized by deep tissue pain, fatigue, headaches, depression and insomnia. It is notoriously difficult to diagnose and treat, and some doctors refuse to recognize it as a disease.

Scientists at King’s College London will study tissue samples and measurements taken from volunteers enrolled in Twins UK, a comprehensive study on the effects of genes, aging, disease and the environment on over 12,000 identical and non-identical twins.

Four hundreds twins are enrolled in the fibromyalgia study. In each set of twins, one twin suffers from chronic widespread pain, while the other does not. Tissue samples from both twins will be compared to try to identify biomarkers in their DNA associated with chronic pain.

"Our research will help patients in two ways. First it'll contribute to our understanding of how fibromyalgia – and other chronic pain syndromes such as irritable bowel syndrome – develop, and point to pain pathways which we may not have suspected,” said lead researcher Dr. Frances Williams.

"Secondly, we hope it'll lead to identification of a biomarker which we could work into a blood test."

Fibromyalgia is believed to have genetic influences, but researchers say there are many complicated steps between the genes that may contribute to fibromyalgia and the condition itself.

The study will focus on identifying markers in DNA that are associated with the “switching” on or off certain genes. DNA switching is important to health, as it prevents inappropriate processes from occurring in the body when they should not. Identifying those markers could then lead to a blood test.

“As well as enabling the condition to be diagnosed more effectively, it could help to ‘stratify’ patients into groups depending on disease severity, which will help in clinical trials of potential new treatments. It might even help us predict how the condition will progress,” said Williams.

A bioresearch company based in Santa Monica, California is already marketing a blood test that it claims is 99% accurate in diagnosing fibromyalgia.

EpicGenetics introduced the blood test in 2013, calling it the first definitive test for fibromyalgia.

The FM test looks for protein molecules in the blood called chemokines and cytokines, which are produced by white blood cells. Fibromyalgia patients have fewer chemokines and cytokines in their blood, according to the company, and have weaker immune systems than normal patients.

The blood test costs several hundred dollars and results are available in about a week. Critics have said the test is unreliable and the same molecules can be found in people with other disorders, such as rheumatoid arthritis.

Better Sleep Means Less Pain

By Pat Anson, Editor

Getting a good night’s sleep plays a key role in determining how bad your pain levels are doing the day, according to a large new study by researchers in Norway.

The study included more than 10,400 adults from an ongoing Norwegian health study. Each participant underwent a standard test of pain sensitivity -- the cold pressor test -- in which they were asked to keep their hand submerged in a cold water bath for 106 seconds.

Only 32% of participants were able to keep their hand in cold water throughout the experiment. Those who suffered from insomnia were more likely to take their hand out early: 42% did so, compared with 31% of those without insomnia.

Pain sensitivity also increased depending on the frequency of insomnia. Those who had trouble sleeping at least once a week had a 52% lower pain tolerance, while those who reported insomnia once a month had a 24% lower tolerance for pain.

"While there is clearly a strong relationship between pain and sleep, such that insomnia increases both the likelihood and severity of clinical pain. It is not clear exactly why this is the case," wrote lead author Børge Sivertsen, PhD, of the Norwegian Institute of Public Health.

The study, which is published in the journal PAIN,  is the first to link insomnia and impaired sleep to reduced pain tolerance in a large, general population sample. The results suggest that psychological factors may contribute to the relationship between sleep problems and pain, but they do not fully explain it.

“We conclude that impaired sleep significantly increases the risk for reduced pain tolerance. As comorbid sleep problems and pain have been linked to elevated disability, the need to improve sleep among chronic pain patients, and vice versa, should be an important agenda for future research,” the study said.

A previous study in Norway found that women who have trouble sleeping are at greater risk of developing fibromyalgia – although it’s not clear if there’s a cause and effect relationship between the two symptoms.

Another study, recently published in PLoS One, found that insomnia – not surprisingly – made chronic pain patients less likely to exercise. Researchers followed 119 chronic pain patients, most of whom suffered low back pain, and found that quality of sleep was the best predictor of physical activity the next day – not mood or pain intensity.

Study: One in Five Opioid Prescriptions for Low Back Pain

By Pat Anson, Editor

Doctors continue to prescribe opioids for low back pain, headaches and fibromyalgia – even though some medical guidelines recommend against their use for such common conditions, according to a large new study.

In an analysis of prescriptions filled for 12 million of its members between July 2013 and September 2014, pharmacy benefit manager Prime Therapeutics found that about one in five opioid prescriptions were written to treat low back pain.

"Our analysis found low back pain was the most common diagnosis among all members taking an opioid, even though medical guidelines suggest the risks are likely greater than the benefits for these individuals," said Catherine Starner, PharmD, lead health researcher for Prime Therapeutics.

Over 22% of those receiving long-acting opioids had been diagnosed with low back pain, nearly 5% had headache and about 2% were diagnosed with fibromyalgia.

In a position paper adopted last year, the American Academy of Neurology found there was “no substantial evidence” for long term use of opioids to treat low back pain, fibromyalgia and headache.

“Collectively, the data suggest that opioids do not improve function in low back pain and therefore should be avoided. While I am an advocate of minimizing opioids to every extent possible, I also believe that absolutes can be damaging," said Beth Darnall, PhD, a pain psychologist, clinical associate professor at Stanford University and author of Less Pain, Fewer Pills.

“In select individual cases, opioids may be one part of an effective pain management plan.  Even then, patients should be monitored closely and opioids used at the lowest dose for the shortest amount of time possible.  The opioid studies are based on large samples and there are always outliers; we must find ways of minimizing risks, protecting patients, and still leaving room for the reality that the medications may be effective for a minority of individuals.”

Nearly 9% of Prime Therapeutics’ members were prescribed at least one opioid during the study period. On average, the cost for those taking short-acting opioids was $72 per member, compared to $907 per member taking only long-acting opioids.

The company said a clinical program that assesses the appropriateness of long-acting opioids could help improve safety and reduce costs. A screening program could also identify members with a significant number of opioid claims in a short period, or those with diagnosed conditions that may not benefit from prolonged opioid use.

"Identifying these members and helping them find the most appropriate pain treatment for their condition could help reduce safety concerns," said Starner.

Darnall says an education program would also help – one that includes non-drug treatments.

“To reduce opioid prescriptions, patients must be given access to effective alternatives,” Darnall said in an email to Pain News Network. “Additionally, by providing patients with education regarding the limitations of opioids and associated risks clinicians may engage patients in their own care and motivate them to seek and try alternatives.  Such alternatives include psycho-behavioral interventions, self-management programs, graded exercise programs, rehabilitation approaches, and the like.”

Prime Therapeutics manages pharmacy claims for health insurers, employers, and government programs including Medicare and Medicaid. It is collectively owned by 13 Blue Cross and Blue Shield Plans, subsidiaries or affiliates.

Survey: Two-Thirds of Patients Unable to Get Hydrocodone

By Pat Anson, Editor

About two-thirds of pain patients say they were no longer able to obtain hydrocodone after the opioid painkiller was reclassified by the U.S. government from a Schedule III medication to a more restrictive Schedule II drug, according to the results of a new survey.

Many patients who had been taking hydrocodone at the same dose for years said their doctor would no longer prescribe the painkiller. Over a quarter (27%) said they had suicidal thoughts after being denied a prescription for hydrocodone.

The survey of over 3,000 patients was conducted online by the National Fibromyalgia & Chronic Pain Association (NFMCPA) and the findings presented this week at the annual meeting of the American Academy of Pain Medicine. An abstract of “Hydrocodone Rescheduling: The First 100 Days” can be found here.

Hydrocodone was rescheduled by the Drug Enforcement Administration in October of last year to combat an “epidemic” of prescription drug abuse. The rescheduling limits patients to an initial 90-day supply and requires them to see a doctor for a new prescription each time they need a refill. Prescriptions for Schedule II drugs also cannot be phoned or faxed in by physicians.

The reclassification quickly made a drug that was once the most widely prescribed pain medication in the country – at nearly 130 million prescriptions each year – to one of the hardest to get.

Other key findings of the survey:

• 88% of respondents believe the change to Schedule II denies pain patients the right to adequate pain care.
• 75% believe the change will not prevent prescription drug abuse.
• 72% believe the change is harmful to pain patients.
• 18% said it led to a "worsened relationship" with their doctor.
• 30% reported "issues" with their pharmacy filling prescriptions.

Patients also reported higher expenses due to increased doctor’s visits, higher co-pays, greater transportation costs to visit the doctor and multiple pharmacies, and lost income due to inability to work because of pain.

The survey is believed to be the first to report on the experiences of pain patients treated with hydrocodone since the rescheduling took effect. The respondents were overwhelmingly female, which reflects the demographics of fibromyalgia and many other chronic pain conditions.

Hydrocodone isn’t the first pain medication to be in short supply. A report released last month by the Government Accountability Office (GAO) faults the DEA for poor management and “weak internal controls” of the quota system under which controlled substances are produced and distributed.

Between 2001 and 2013, the GAO said there were 87 “critical” shortages of drugs containing controlled substances, over half of them pain relievers. The vast majority of drug shortages lasted over a month and some dragged on for years. An oral solution of oxycodone was difficult to obtain for eight and a half years.

“The shortcomings we have identified prevent DEA from having reasonable assurance that it is prepared to help ensure an adequate and uninterrupted supply of these drugs for legitimate medical need, and to avert or address future shortages. This approach to the management of an important process is untenable and poses a risk to public health,” the report states.

Lyrica Fails in Study of Juveniles with Fibromyalgia

By Pat Anson, Editor

Lyrica, a blockbuster drug widely prescribed to treat chronic pain in adults, works no better than a placebo in treating juveniles with fibromyalgia, according to the results of a new study released by Pfizer (PFE). Lyrica is Pfizer’s top selling drug with annual worldwide sales of over $5 billion.

The double-blind Phase IV trial was conducted to fulfill a post-marketing study required by the Food and Drug Administration after Lyrica was approved for the management of fibromyalgia in adults in 2007. The generic name of Lyrica is pregabalin, which was originally developed as an anti-epileptic drug.

“The primary endpoint of the study was not achieved as there was not a statistically significant difference between pregabalin and placebo in mean pain score,” Pfizer said in a statement.

A total of 107 adolescents (ages 12-17 years) were enrolled in the 15-week study at multiple centers across the U.S., Europe and Asia. It was the first large study on the efficacy and safety of Lyrica in juveniles with fibromyalgia.

The National Institutes of Health estimates that about 5 million Americans suffer from fibromyalgia, a poorly understood disorder characterized by deep tissue pain, fatigue, headaches, mood swings and insomnia.

In the study, Lyrica was administered twice daily, starting at 75 mg/day and then increasing to up to 450 mg/day, depending on the tolerability and response of the patient. The most common side effects in the study were dizziness, nausea, headache, increased weight and fatigue. Many other patients who take Lyrica complain of similar symptoms.

"Pfizer is committed to better understanding the full clinical profile of our approved medicines in pediatric and adolescent patients. This study advances the understanding of this patient population," said Steve Romano, MD, senior vice president of Global Medicines Development for Pfizer. "These results do not change the established benefit of Lyrica for its approved indications, including fibromyalgia in adults."

In addition to fibromyalgia, Lyrica is approved by the FDA to treat chronic pain associated with 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.