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

~ • ~ • ~ • ~ • ~ • ~

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. 

More FM drug trials of the same, really? 1990 vs 2010 Criteria, which is it? My comment by Celeste Cooper

Am I in a fibrofog? Is this new drug trial for pain or for cognitive dysfunction in FM or both? The news reports are confusing. Is one right and the other wrong? They can’t both be right, can they? I went on a search. You can find the answer at the bottom on this blog.

New Fibromyalgia (FM) Clinical Trial Now Enrolling at Avail Clinical Research in Central Florida; Accepting M/F Patients with Fibromyalgia Age 18-59. June 30, 2013 Digital Journal, read here. 

There was no place to leave a comment. I would have because cognitive deficit is a primary symptom of fibromyalgia. Its effects are more extensive, including complete word loss, sudden onset dyslexia, severe and alarming short term memory loss etc. When we compare these cognitive affects with those experienced by people with chronic pain in general, there is a difference. My thinking is that some of these symptoms can also be attributed to hypothyroidism, and non-restorative sleep evidenced by loss of slow wave progression in sleep studies of fibromyalgia patients. This leads to the next question, "Will these factors be considered in participant screening? (More to come later). 

I found some red flag words - “mood disorders,” which can include biological psychiatric conditions, such as "bi-polar disorder" or "major depressive disorder," neither to be confused with a normal situation reaction of temporary anxiety or depression. These are terms that should not be used flippantly. As a chronic pain advocate and fibromyalgia expert, why?  What fibromyalgia patients experience is not different that the situational depression or anxiety that others with chronic pain experience. I will compromise that catastrophic thinking can sustain symptoms, but I am perplexed as to why anyone thinks it is any different in fibromyalgia when resent research suggested overwhelmingly that FM is a biological disorder. Are we to think that because migraine, interstitial cystitis, periodic limb movement and bruxism in sleep, and many of the comorbid conditions to FM should also be considered as "mood disorders?" Really?

This particular article suggests the 1990 criteria will be used to screen participants; however, that is not the case, which leads to more confusion. I suspect it is because the reporter saw that comorbid conditions are recognized, unlike what is suggested in the 2010 criteria. 

Accurate reporting is necessary. Read on to understand why this is a concern to me.

The next article just released. I was able to leave a comment:

New Fibromyalgia (FM) Clinical Trial Now Enrolling at Achieve Clinical Research in Birmingham, Alabama; Accepting M/F Patients with Fibromyalgia Age 18-70. July 1st, 2013 WatchListNews Press Release, here.

I hope this drug trial is targeted at a defective immune system versus chronic pain in general. Results of the FM/a Test have been overwhelming post research, and the follow up study in progress is ruling out the immune blood protein findings in FM in other rheumatological conditions. Otherwise, this study is on chronic pain in general. 

The number of Americans with chronic pain was amended from 116 million to an estimated 100 million, and the 2010 Preliminary Proposed criteria for diagnosing fibromyalgia has met with a great deal of criticism. The tool is confusing and does not require a physical exam. Many are boycotting this criteria because it is confusing and misleading. Since there is a blood test now for diagnosing FM, would that be a better place to start? It would certainly rule out any psychological illness that might otherwise be inaccurately diagnosed as FM.  The Wolfe, et al. criteria was amended in 2011 as "modified," and does NOT look specifically at the comorbid disorders you discuss. Instead, it looks at polysymtomatic syndrome as defined in the American Psychiatric Association diagnosis manual the DSM-5.

Side note: See “Fibromyalgianess is ALL in Our Head? My Correspondence with Dr Frederick Wolfe.”  Here.

I am highly suspicious that this drug trial is more of the same. While antidepressants and anticonvulsants medications help with chronic pain, the evidence has been underwhelming. Treating an immunological disorder with an SNRI, SSIR, [oops should have been SSRI] or anti-seizure meditation or a similar drug in those classifications is not going to improve patient outcome. Look at the prevalence of hypothyroidism in FM, would such drugs help with these symptoms? I suggest a really good review of the recent research regarding immunological factors, A-V shunting in the hands of FM patients, and the presence of small fiber neuropathy.

Last, but certainly not least, I saw no mention that patients would be screened for comorbid myofascial pain syndrome?  There is plenty of research and evidence to suggest that myofascial trigger points and attachment trigger points are present in ALL patients with chronic pain. The difference is investigating why latent MTrPs are easily activated in fibromyalgia when compared to the usual aggravating factors, spinal misalignment, posture, joint deformity, etc. I suspect the immunological effect of FM plays a role.

I suggest they change their study cohorts to people with chronic pain in general.

From PRWeb visit: http://www.prweb.com/releases/fibromyalgia/trials/prweb10886175.htm

OBJECTIVES:

The primary objective of the study is to assess the ability of a new drug to reduce Fibromyalgia pain. Specifically, this will be accomplished by evaluating the safety and efficacy of a 6-week treatment regimen with this new Fibro drug, to a maximum dose of either 5 mg or 20 mg, relative to placebo, in subjects with FM. Efficacy will be assessed on the basis of the baseline-adjusted weekly mean pain score obtained in the last week of treatment, as derived from subjects’ daily reports in an electronic diary. Daily pain scores will be reported on an 11-point numeric rating scale (Pain-NRS).

The secondary objective of the study is to assess overall improvement in fibromyalgia following treatment with a new Fibro drug relative to placebo. This will be assessed by:

•the Patient Global Impression of Change (PGI-C); and

•the Fibromyalgia Impact Questionnaire (FIQ) total score.

5. Diagnosis of primary fibromyalgia (FM) as defined by the 2010 American College of Rheumatology Preliminary Diagnostic Criteria for Fibromyalgia

All blog posts and answers are not to replace medical advice.

Learn more about Celeste and her endeavors as patient, RN, educator and advocate at http://TheseThree.com