Wednesday, July 11, 2018

FDA responds on behalf of chronic pain patients who require opioids to treat their pain


https://www.usatoday.com/videos/news/politics/2018/07/02/fda-chief-says-long-term-opioid-prescriptions-needed-some-chronic-pain-patients/752552002/


As I said in my June blog, 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.

Hope has turned in to reality; the FDA is listening! 
Our voice is being heard, so let’s keep using it.



ID: FDA-2018-N-1621-0001
The Food and Drug Administration (FDA)

“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.

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


Adversity is only an obstacle if we fail to see opportunity."


Additional Reading:

Opportunity Knocks Again: Public Comments on Patient-Focused Drug Development for Chronic Pain (includes my comment)


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. 

Thursday, July 5, 2018

The FM/a® Blood Test and Participation in Fibromyalgia Vaccine Study



The FM/a® Test is making a huge impact on the way fibromyalgia is diagnosed and now it is being used for very important research.










In November of 2017, I wrote about the exciting research that focuses on finding the cause and developing a treatment for fibromyalgia. (1) February of this year, I reported that genetic studies on fibromyalgia are well underway – with the assistance of the University of California, UCLA, and University of Illinois at Chicago. (2) In April of 2017, “Breaking News" included information relative to this announcement. (3)

Under contract with researchers from both UCLA and the University of Illinois College of Medicine Chicago, Campaign 250 will conduct Whole-Exome genetic testing on up to 250,000 patients who have received a positive FM/a® fibromyalgia diagnosis

Based upon the findings of this testing and once treatment protocols have received regulatory and institutional approvals, FM/a® Test positive patients will be invited to participate in a fibromyalgia-specific vaccine clinical trial to reverse the biology of fibromyalgia…

I am excited to report that the long-term reduction in hyperglycemia in advanced type 1 diabetes using BCG vaccine found that after year 3, BCG lowered hemoglobin A1c (a blood test to monitor blood sugars over a period of time) to near normal levels for the next 5 years. That is a significant result. This same vaccine was reported in the above "Breaking News" statement. This is important because this old vaccine for tuberculosis now shows promise as treatment for numerous inflammatory and autoimmune diseases.

BCG = attenuated Mycobacterium bovis Bacillus Calmette Guérin (BCG) strain.

Professor Denise Faustman, specialist in immunology who is affiliated with Harvard Medical School and Massacheusetts General Hospital, was a lead researcher in the vaccine study for diabetes and she will lead the vaccine study for fibromyalgia. The only qualification to participate in this exciting research is to have tested positive with the FM/a Test.

“FM/a® is a multi-biomarker-based test which concerns immune system white blood chemokine and cytokine patterns. Patients with fibromyalgia have a significantly dysregulated pattern regarding these proteins.

I am a participant in the genome study and will be enrolled in the vaccine trial.

Will you join me?



PLEASE VISIT


The blood test is now covered by most insurance, including CHAMPVA and Medicare.

Resources:





Additional Information:




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, 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!



~ • ~ • ~ • ~ • ~ • ~

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!


~ • ~ • ~ • ~ • ~ • ~

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. 

Celeste's Website

Celeste's Website
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