Sunday, June 17, 2018

Opportunity Knocks Again: Public Comments on Patient-Focused Drug Development for Chronic Pain





As an advocate, registered nurse, and patient, I feel we are forced to work within a system devoid of a plan for addressing the physiological, psychological, financial, and social consequences of living with persistent pain.
If we want change, we are obliged to share our unique individual circumstances and our life encounters. If you have been affected by having your opioids restricted, if you want pain management that fits within your personal framework, it’s time to use your voice.

ID: FDA-2018-N-1621-0001

Summary:
The Food and Drug Administration (FDA, the Agency, or we) is announcing a public meeting and an opportunity for public comment on “Patient-Focused Drug Development for Chronic Pain.” The public meeting will provide patients (including adult and pediatric patients) with an opportunity to present to FDA their perspectives on the impacts of chronic pain, views on treatment approaches for chronic pain, and challenges or barriers to accessing treatments. FDA is particularly interested in hearing from patients who experience chronic pain that is managed with analgesic medications such as opioids, acetaminophen, nonsteroidal anti-inflammatory drugs (NSAIDs), antidepressants; other medications; and non-pharmacologic interventions or therapies.

The public meeting will be held on July 9, 2018, from 10 a.m. to 4 p.m. Submit either electronic or written comments on this public workshop by September 10, 2018. See the SUPPLEMENTARY INFORMATION section for registration date and information.

Comment Now!
Due Sep 10 2018, at 11:59 PM ET

My comment:

First, thank you for listening to the voice of patients. As an RN and lead author of five books on pain and integrative therapies, I am sickened when I read about another suicide by a fellow pain patient, resulting from the crackdown on opioid prescribing. I am concerned about accountability, because physicians bear the consequences of not treating their patients. I am angry about the false narrative of media reporting.

As a person living with persistent pain and autoimmune disease, I use every alternative tool available to me, including invasive pain management. I participate in physical therapy, but Medicare doesn’t allow enough visits to be therapeutic. I do everything I can to keep opioid use to a minimum, yet I feel judged by my government for needing it? I have severe damage to my body from NSAID overuse. They are not a safer than opioids. I do not tolerate the side effects of antidepressants. Anti-seizure medications disconnect me from reality. I feel like a free guinea pig for the pharmaceutical industry, as I take the risk of off-label trials while they make the money. I am elderly and I am angry that my primary doctor will no longer prescribe the small amount of opioids that work for me, that I can afford, and that allow me to participate in integrative therapies.

Pain physicians are overworked and now either restrict their practice to interventions only or require monthly visits. Many of us do not have transportation to pain clinics or the ability to make co-payments. These practices are driving the cost of pain care to the moon. There is a lack of evidence that urine drug tests are consistently accurate or that they are having any effect on drug addiction, yet these companies make a large profit off vulnerable patients.

People who live with unrelenting pain should have their pain managed well enough to participate in integrative therapies like mindfulness, tai chi, physical therapy, etc. Education is needed, not prohibition. The money wasted on the war on drugs could be used to develop outcome-based programs to help people with drug addiction and research for those of us who live with daily unforgiving pain.

Again, thank you for taking public comments. I am more than a statistic, I am  one face of pain.



In healing,

Celeste Cooper, RN / Author, Freelancer, Advocate

Think adversity?-See opportunity!



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Learn more about Celeste’s books here. Subscribe to posts by using the information in the upper right hand corner or use the share buttons to share with others. 

Thursday, June 7, 2018

Migraine and Me: If you could see me now #MHAM2018 challenge


Migraine is the 3rd most prevalent
and 7th most disabling disease in the world.



As I reported in my blog 12 Months and 14 Fibro Musings from The Pained Ink Slayer, the spring and fall seasons are two difficult times of the year for me. I live with chronic migraine all year long, but barometric pressure changes and tree and grass allergens can lead to a status migrainus attack, a migraine lasting for more than 72 hours straight. In May, a very busy month for fibromyalgia advocates, I experienced an episode lasting 14 days that required a steroid blast to stop it. And, I can't remember doing a fibromyalgia awareness interview without a migraine.

THE SHADOW OF MIGRAINE

”Hiding my migraines on the set may have been my toughest challenge as an actor. There were times when the pain from migraine headaches was so severe that I literally had to crawl across my dressing room floor. But I couldn't let anyone know. If they thought I might slow production, I figured that would end my career.”
~Morgan Fairchild

If you live with migraine, you know exactly what this is like. As a high school student, I spend many a day lying on a cot in the nursing office. As a young adult, I remember retreating to the bathroom to vomit and escape the overhead lights of the office where I was a switchboard operator, fearing every second that I would lose my job over something I could not control. I remember the look my mother's face when she came to pick me up to take me to the emergency room, where my condition called for stat IV's and lab work to check my clotting factors. Unbeknownst to me all the tiny blood vessels in my face had ruptured (my head had been over the toilet for the better part of a day). I barely had a blood pressure.  

Unless you have migraine disease, you simply cannot understand what that means. It is so much more than a bad headache. It will cause sane people to do crazy things. I can tear sheets with my teeth, rock back and forth on my hands and knees, and cry out in pain with the guttural sounds of an injured animal, sounds that even I do not recognize. I have pressed so hard on my eye sockets that it leaves bruises. I slur works like a drunk, speak in sentences that make no sense, and experience complete personality breakdown.

THE STIGMA

Despite all the evidence that migraine is real, and that it is a neurobiological disease of the brain, we still feel the stigma of migraine. I wish I could say we didn’t need migraine awareness campaigns, but we do. Few understand what we have learned in the last ten years and we need to change that.

Read more about the research and the common denominators of those of us who live with both migraine and fibromyalgia in an article I wrote for ProHealth, Fibro Playmate of the Month–The Migraine Connection.  

Life isn’t easy living with migraine, but when I share my story, I am able to emerge from the shadow of migraine. I hope you will too. #MHAM2018


Find out how YOU can get involved. JOIN THECHALLENGE at MigraineDisease.com where you will find all you need to raise awareness and stop the stigma of migraine.

In healing,

Celeste Cooper, RN / Author, Freelancer, Advocate

Think adversity?-See opportunity!


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Learn more about Celeste’s books here. Subscribe to posts by using the information in the upper right hand corner or use the share buttons to share with others. 

Saturday, June 2, 2018

Comment Now to NIH Pain Management Best Practices or Forever Hold Our Peace


The comment period has been extended to June 15th.

PLEASE NOTE: Following is my voice. Your story is different from mine. To date there are only 1454 comments out of over 100 million Americans who live with chronic pain. I know there are  more who want to comment, because I hear from you, and now, they want to hear from all of us. 

Our stories put a face to the meaning of our plight to be treated with dignity and respect. We are more than statistics and it's time to show it. 


“Our lives begin to end 
the day we become silent 
about the things that matter.”

~Martin Luther King



When you are finished, you will receive a "Comment Tracking Number".

RE: Meeting of the Pain Management Best Practices Inter-Agency Task Force
Docket ID: HHS-OS-2018-0009 Agency: Department of Health and Human Services (HHS)

Those of us living with chronic pain deserve to have our pain treated, yet the illegal drug abuse epidemic is making it impossible to receive the care we need to survive. As an RN and lead author of five books on pain and integrative therapies, I am sickened when I read about another suicide by a fellow pain patient, one that resulted from the government "crackdown" on opioid prescribing. I am tired of hearing how physicians will no longer prescribe a drug they have been using for years because they are fearful of the DEA. I am a person aging with severe inoperable musculoskeletal disease and a lesion in my sacrum that causes such pain I cannot bear weight or sleep. When it flares, I get epidurals, but they are limited. Why does the government think they can judge me for needing an opioid? I have severe damage to my esophagus and stomach from NSAID overuse. My mother died from a heart attack caused by NSAIDS, yet we never hear about how unsafe they are with prolonged use. I tried the antidepressants, they did not help, and the side effects were intolerable. Lyrica® and Neurontin® disconnected me from reality. I am not alone in this, so why don’t we hear about that? I am elderly and I am angry that my primary doctor will no longer prescribe the small amount of opioids that work for me, that I can afford, and that allow me to participate in other practices I find helpful. Government overreach has led to this lunacy. Pain physicians require monthly visits, whether you need a new prescription or not. These practices are driving the cost of pain care to the moon. Making patients succumb to a pee test is demoralizing, and they aren't all accurate, resulting in the destruction of innocent lives, yet they are allowed, even encouraged, to add to the burden of escalating costs. What happened to watching for untoward behaviors and making appropriate referrals? Few patients expect total relief with opioids, but it should be their right to have their pain managed well enough to participate in integrative therapies like mindfulness, tai chi, physical therapy, etc. Education is needed, not prohibition. Addicts deserve to have the "right treatment", not therapy based on ability to pay. Money is being wasted on the war on drugs that could be used to develop outcome-based programs to help these people. Many of us live with debilitating conditions for which there is no cure and opioids are the treatment of last resort. Many of us do not have transportation to pain clinics or the ability to make co-payments. Please hear my voice. The crime here is allowing people in pain to be exploited by those who profit from our demise, and a false narrative driven by media hype.


In healing,

Celeste Cooper, RN / Author, Freelancer, Advocate

Think adversity?-See opportunity!



~ • ~ • ~ • ~ • ~ • ~

Learn more about Celeste’s books here. Subscribe to posts by using the information in the upper right hand corner or use the share buttons to share with others. 

Sunday, May 27, 2018

12 Months and 14 Fibro Musings by The Pained Ink Slayer



As fibromyalgia awareness month winds down, I am reminded of all the wonderful work of advocates and fellow bloggers. However, this month is a difficult one for me personally, because I also have chronic migraine; and the unstable atmosphere of spring weather is a trigger I cannot control. Fibromyalgia and its partners can be more than a physical challenge. For instance, a special PAINS-KC meeting I looked forward to attending was side railed because of what would end up being a 14-day status migrainosus. And, I can’t remember doing an interview for May awareness that I did not have migraine. Unintentionally, this introduction is also a segue to June headache and migraine awareness month, stay tuned.

What I write is rooted in my personal quest for help. I have learned to forgive myself for the things I can’t control and to embrace adversity. I realize that good days for others are spectacular to me. I hope you find something that is helpful for you.

Note: For future reference, archived blogs are in the right column of this page, Celeste’s freelance articles are in the header tab Celeste’s Publications, and this particular blog will be linked in the header tab Fibro Musings.


  

Ways we can manage the effects of fibromyalgia on our central, autonomic, metabolic, and immune systems…



Explore the types and benefits and practices tai chi, dubbed “medication in motion” for those of us living with chronic pain…




There is a well-documented bidirectional pathway between the brain and gut. Read about fibro-mates, IBS and GERD, and evidence on supportive therapies of the mind…





Determining the most beneficial type of therapeutic massage or bodywork relies on our understanding of the differences between fibromyalgia and myofascial pain syndrome. What massage techniques can help?...



What type of movement is showing promise for managing our fibromyalgia? You might be surprised to see the recent evidence…






Fibromyalgia and EDS (hEDS = EDS hypermobile type) share connections you might not have considered…





What you may not know about your symptoms, stressors, and management tools…




About the male and female fibromyalgia pelvis, pain and the myofascia, diagnosis to treatment…





Genetic studies on fibromyalgia are underway with the assistance of the University of California, UCLA, and University of Illinois at Chicago using the FM/a blood test to identify participants.



Thyroid problems can co-exist with and/or sometimes mimic fibromyalgia, the science, medicine, and awareness...





To understand why manual lymphatic massage is beneficial for those of us with fibromyalgia, we must first understand how it works.





Why does myofascial pain become chronic? What causes the chronic pain of fibromyalgia? Does myofascial pain sustain fibromyalgia pain? Difference between a trigger point and tender point, and more...




The FDA "Voice of the Patient", getting unstuck, the biology of body matter, immune cells, and noteworthy news...





Are your arms and legs like battlefield magnets? Do your extremities look like a world atlas? For those of us with fibro, there might be an explanation to why that is.





Disparity, agreements, 2016 Revisions to the 2010/2011 Fibromyalgia Diagnostic Criteria appear to address previous concerns, and now conclude...




Don’t miss:
The Pain Advocate’s Corner: How to Raise Your Voice
(also permalinked in the header tab of The Pained Ink Slayer).


“To unleash victory, I must have an open mind and willing heart,
judge not, embrace change, and be a steadfast observer of self.”


In healing,

Celeste Cooper, RN / Author, Freelancer, Advocate

Think adversity?-See opportunity!



~ • ~ • ~ • ~ • ~ • ~

Learn more about Celeste’s books here. Subscribe to posts by using the information in the upper right hand corner or use the share buttons to share with others. 

Wednesday, May 2, 2018

Science, Fibromyalgia, and Exercise


Courtesy Pexels.com

Last year I wrote about the importance of critical thinking and problem solving and casting a light on recurring theories. This year, I decided to kick off a review of the research beginning with a look at exercise and fibromyalgia.
                                
In my 2015 blog, I asked "Can Aerobic Exercise Reduce Fibromyalgia Symptoms?" As I said, the answer is tricky because there is evidence that aerobic exercise can reduce symptoms, and there is evidence to suggest it can increase symptoms. So, maybe we should look at the evidence on different types of exercise, like warm water (aquatic) exercise, yoga and stretching, and aerobic exercise vs. tai chi.
                                                                                   
AQUATIC EXERCISE

Using assessment parameters we usually see when studying fibromyalgia, researchers (2008) looked at the effectiveness of aquatic (warm water) therapy compared to home based exercise therapy.  They found that both aquatic therapy and home-based exercise programs have beneficial effects. However, when considering pain management, only aquatic therapy had longer lasting effects. And, a 2015 study revealed that a pool-based aquatic aerobic exercise program was the most effective treatment when compared to isometric strength-stretching and aerobic exercise. So, can we conclude aquatic therapy is good for fibromyalgia, maybe not?

In 2014, Bidonde J, et al. concluded that there is low to moderate quality evidence to suggest that aquatic training is beneficial. And “very low to low quality evidence suggests that there are benefits of aquatic and land-based exercise, except in muscle strength (very low quality evidence favoring land)”. What are we to think? 

Ai Chi = The use of breathing techniques and progressive resistance training in water to relax and strengthen the body, based on elements of qigong and Tai chi chuan.

I personally found aquatic therapy made my myofascial pain syndrome pain much worse. Enter Ai Chi. Knowing my past experience, my physical therapist encouraged me try Ai Chi. Trusting in him, I did. It is very different and I liked it. So, it comes as no surprise to me that a 2016 pilot study found “significant differences in values such as pain perception, vitality, mental health, as well as perceived overall improvement in quality of life”. This new approach (Ai Chi), rather than aquatic strength training, may make a difference in the benefits of warm water therapies. 

RESISTANCE EXERCISE

Research on resistance training (isometrics, weight training, etc.) is reported by the experts to be of low quality, so I am not entertaining it here.

STRETCHING AND YOGA

A 2014 Brazilian review, Effects of muscle stretching exercises in the treatment of fibromyalgia, found significant improvement in all studies regarding pain and quality of life. However, they concluded that even though it is clear that muscle stretching for fibromyalgia is important, there is a need for further studies because of the low quality of methods used and the lack of standardization for comparative analysis. This makes it difficult to know if a certain stretching technique is better.

What about yoga?

A 2011 pilot study suggests a protocol for managing fibromyalgia with yoga and meditation. While they do report positive responses, there were only 11 participants.

Courtesy Pexels.com

Side note: I do a few gentle flowing yoga poses as a warm up to tai chi. If my chest feels restricted, I get right to breathing through the child’s pose. Tree pose is my barometer for knowing when I need to work on balance before I do something stupid, like fall over for no reason, or sling my arms into walls, what I call in our BIG book, the “Bull in the China Cabinet Effect.” I have learned that holding postures will activate trigger points and cause mind-altering pain. But, stretching can feel so good; and when it’s done right, it should.


A small 2017 mindful yoga pilot study found fibromyalgia symptoms and functional deficits improved significantly, as did physical tests of strength and balance, and pain coping strategies. These findings indicate that further investigation is warranted into the effect of Mindful Yoga on neurobiological pain processing.”

AEROBIC EXERCISE vs. TAI CHI        

Aerobic exercise is often suggested as a first line treatment for fibromyalgia. However, as recently as 2017 that could change. In a review, researchers report those of us with fibro may see little to no difference in our pain and physical function from aerobic exercise. Quote, “We downgraded the evidence owing to the small number of included trials and participants across trials, and because of issues related to unclear and high risks of bias (performance, selection, and detection biases). Aerobic exercise appears to be well tolerated (similar withdrawal rates across groups), although evidence on adverse events is scarce, so we are uncertain about its safety.” There is some research to suggest the way our body responds to exertional demands could play a role in our intolerance to aerobic exercise, such as running, biking, or other physical activities that increase our heart rate.

Balancing Rocks-Celeste's Photography
There is a great deal of evidence to suggest tai chi is beneficial for improving fibromyalgia symptoms and mobility.  Maybe that’s because our autonomic nervous system tolerates the gentle movements of tai chi better than aerobic exercise. A randomized controlled trial published on March 23, 2018 looked at the effects of tai chi training in relationship to heart rate variability, symptoms, and muscle fitness in women with fibromyalgia and suggest tai chi may be effective for improving autonomic balance, pain, fatigue, strength and flexibility in women with fibromyalgia. And, a study published March 21, 2018 found “tai chi mind-body treatment results in similar or greater improvement in symptoms than aerobic exercise”.

It’s important for anyone with chronic pain to keep moving. And, when it comes to fibromyalgia, it appears the positive results are more likely if the practice of mindfulness is included with exercise.

Additional Reading:

A Year of Fibro: Musings, Writings, and Opinions, May 2016. A recap of my writings on fibromyalgia


In healing,

Celeste Cooper, RN / Author, Freelancer, Advocate

Think adversity?-See opportunity!



~ • ~ • ~ • ~ • ~ • ~

Learn more about Celeste’s books here. Subscribe to posts by using the information in the upper right hand corner or use the share buttons to share with others. 

Celeste's Website

Celeste's Website
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