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

https://www.regulations.gov/document?D=FDA-2018-N-1621-0001

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!

http://www.CelesteCooper.com

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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. 

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.

(MigraineDisease.com)

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!

http://www.CelesteCooper.com

~ • ~ • ~ • ~ • ~ • ~

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. 

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

PLEASE COMMENT at  https://www.regulations.gov/docket?D=HHS-OS-2018-0009

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!

http://www.CelesteCooper.com

~ • ~ • ~ • ~ • ~ • ~

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.