Question 1

FDA Grants Breakthrough Device Designation for groundbreaking device for Fibromyalgia management

Accepted Answer

Sabrina Dudley-Johnson
May 19, 2022

A May 12, International Fibromyalgia Awareness Day, press release at Cision PR Newswire announced the FDA has granted Breakthrough Device Designation to a new French business named Remedee Labs for its endorphin stimulator as a potential tool for the management of Fibromyalgia.  The press release states that "this designation recognizes both the highly innovative nature of Remedee's device and its potential benefits for fibromyalgia patients adjunctively with standard of care.  Obtaining Breakthrough Device status is a strong first step toward US market authorization."[1]

A quick review of Remedee Labs website reveals their motivation.  Remedee reports, "by combining advanced scientific Research with leading-edge micro and nano-technologies, we have built the first personal endorphin stimulator ... for pain management.  This new approach works by releasing a person’s own endorphins – recognized as the body’s highly effective natural pain killer – in a safe, fast and simple way." [2]

This endorphin stimulator is not available in the United States as of the writing of this article.  Remedee Labs advises that they intend for their device to be used as a component of a patient-centered, multidisciplinary, team approach treatment protocol. [3]

The Fibro Diva Report has not received compensation for this article.  The author has not had personal experience with this device.  The press release listed in the May 19, 2022, post on "Thoughts In From The Fog" blog merely peeked interest.

Endnotes:
[1] FDA Grants Breakthrough Device Designation to Remedee Labs for its groundbreaking endorphin stimulation solution for the management of Fibromyalgia 
Cision PR Newswire
Press Release
May 12, 2022
[2] Remedee Labs 
[3] Remedee Labs

Question 2

Fibromyalgia Awareness 2022

Accepted Answer

The Fibromyalgia community has been very busy this month getting the word out about Fibro.

National Fibromyalgia Awareness Day: What is fibromyalgia? | News | nbcrightnow.com
‘The ultimate bully’: Local perspectives on Fibromyalgia Awareness Day | WSAV-TV
Support Fibromyalgia at Capitol Hill 
National Fibromyalgia Awareness Day Highlights Debilitating Condition | Newsmax.com

Question 3

FDA Awards Breakthrough Device Designation for a Digital Therapy Program for Fibromyalgia

Accepted Answer

August 17, 2021, Techcrunch.com announced that "Swing Therapeutics, received an FDA breakthrough device designation for their 12-week smartphone-assisted Fibromyalgia management program."  Swing Therapeutics has developed what they call an "Acceptance and Commitment Therapy" program. 
 
In a 2019 article in Practical Pain Management, Rosemary Black discusses Acceptance and Commitment Therapy (ACT) and Cognitive Behavioral Therapy (CBT).  Ms. Black reports:
 
"CBT views pain as a complex experience influenced by a patient’s thoughts and behavior.  The purpose of CBT is for a patient to identify their negative thoughts and behavior surrounding pain" and then replace them with positive ones.  Ms. Black explains that the purpose of ACT is to "help patients learn to accept their thoughts and feelings [instead of trying to ignore or deny them]."
 
Techcrunch.com explains the importance of the FDA recognition for Swing Therapeutics stating:
 
"Designation will allow Swing Therapeutics expedited review at the FDA as the company conducts a series of clinical trials on the product.  There’s some evidence ACT can help patients who live with chronic pain (including fibromyalgia)."
 
Swing Therapeutics' ACT program is similar to a functional capacity therapy program in which the person with chronic pain reports to an intense program 5 days a week for up to eight hours a day, for 4 or more weeks.  In functional capacity therapy participants engage in physical therapy, cognitive behavioral therapy, and learn about their physical condition.  In the ACT program, the participant will utilize their smart phone 5-7 days a week for 12 weeks.  The participant will be provided "lessons" and tasks to complete.
 
Ms. Necie Edwards of the Fibromyalgia Patient Education and Support organization, a 501 (c) (3) nonprofit organization in Vernon Hills, IL, informs the Fibro Diva Report that Swing Therapeutics is currently accepting participants.  Click here for more information and to see if you qualify.
 
For More Information visit:
https://react-fm.com/welcome/003/fibropatient?fbclid=IwAR0LCUBiAy-lbnkBHzQKmgI5uWiw1MsSF8PiMQGriPYeVUwHtBC430m8tgg
 
https://www.fibromyalgiapatienteducation.info/
www.techcrunch.com/2021/08/17/digital-therapy-program-for-fibromyalgia-receives-fda-breakthrough-device-designation/
 
https://www.practicalpainmanagement.com/patient/treatments/mental-and-emotional-therapy/cbt-act-therapy-chronic-pain-how-does-psychotherapy

Question 4

Growing Fibromyalgia Awareness

Accepted Answer

May is Fibromyalgia Awareness Month so I designed a garden flag.

Question 5

People with Fibromyalgia: Community or Market?

Accepted Answer

When Fibro advocates refer to the portion of the population with Fibromyalgia, they often use terms/pharses like Fibromyalgia Community, fostering a sense of community.  This author has never heard an advocate use the term "Fibromyalgia Market".  Will researching for news items on FM, this author came across several articles that discuss the "Fibromyalia Market".  These were all articles on stocks and companies, not on patients as peoples.  To understand what I was finding I had to learn the difference between "Community" and "Market".
 
Community
In her dissertation research: Sense of Community in a Mediated World, Dr. Jenny Fremlin found that the term "sense of community" means "the sense that one was part of a readily available, mutually supportive network of relationships upon which one could depend and as a result of which one did not experience sustained feelings of lonelines." [1]  A community is a group of people with a shared connection that binds them together.
 
Market
A means by which the exchange of goods and services takes place as a result of buyers and sellers being in contact with one another, either directly or through mediating agents or institutions. [2]
 
So, as patients and advocates, when we think of the Fibromyalgia population, we are thinking of ourselves as a community.  We are people with a common connection, chronic pain, fatigue, fibro fog and other symptoms.  We can meet in support groups (in-person or online), on Facebook pages, or talk to each other over the phone and feel safe discussing how Fibromyalgia has effected us.  But the manufacturers of pharmacetuicals look at us as an open wallet, a source of income. I'm sure there are pharmacetuical companies out there working to develop new or repurpose existing medications because they truly want to eleviate the painful suffering of people with Fibromyalgia.  However, when oen reads articles on The FIbromyalgia Market, they merely discuss:
 
1.  Various available and potential drugs.
2.   Vehicles with which to destribute these drugs.
3.   Global regions most likely to produce the greatest drug sales. (So far, the United States is the biggest market for Fibromyalgia treatment" [3]  Transparency Market Research presented a ten year global forecast into the Fibromyalgia Treatment Market reporting, "the North America fibromyalgia treatment market contributes maximum revenue share in global fibromyalgia market." [4]
 
I'd rather be thought of as a member of a community than as a source of ongoing revenue, but maybe I'll look into some stocks.

Endnotes:
[1] http://www.senseofcommunityresearch.org/research/updates/identifying-concepts-that-build-a-sense-of-community
[2] https://www.britannica.com/topic/market
[3] https://www.transparencymarketresearch.com/fibromyalgia-treatment-market.html
[4] Ibid.

Question 6

Fibromyalgia and Vitamin D

Accepted Answer

Twelve weeks of high-dose vitamin D supplementation does not improve pain levels for women with fibromyalgia, research suggests.  In a 12 week double-blind study, published in Clinical Rheumatology, female participants were divided into two groups, those who got 50,000 IU of Vitamin D3 and those who only got a placebo.  The beginning baseline level of pain and Vitamin D was similar for both groups.  At the end of the 12 week period, levels of both pain and Vitamin D increased in both groups.  Of course, the group that got the Vitamin D saw a higher level of increase of the supplement.  The study found that there was no connection between an increase in Vitamin D and a reduction in pain.
 
https://www.medwirenews.com/rheumatology/fibromyalgia-related-pain-not-improved-vitamin-d-supplementation/18919150

Question 7

Gout Treatment for Fibromyalgia Pain

Accepted Answer

Fibromyalgia News Today reports, "Allopurinol, which is sold under the brand name Zyloprim, is a medicine used for gout and high levels of uric acid, significantly lessened pain in women with fibromyalgia who failed to respond to conventional therapies, a pilot study shows." [1]  In a pilot study, Brazilian researchers wanted to determine if allopurinol could help alleviate pain in people with fibromyalgia. Researchers saw a reduction in pain in the female participants. [2]
 
Endnotes:
[1] https://fibromyalgianewstoday.com/2021/02/16/gout-treatment-may-lessen-fibromyalgia-pain-pilot-study-suggests/?cn-reloaded=1
[2] Ibid

The Fibro Diva Report

Fibromyalgia In The News