Tag Archives: chronic pain syndrome

Dear Fibromyalgia Stakeholders: As Promised, a Message from the United States Food and Drug Administration

textgramTo my Fellow Fibromyalgia patients, friends, and loved ones:

I received an email today from the United States Food and Drug Administration (FDA) notifying participants of the full recording that is now available from the meeting held with fibromyalgia patients March 26, 2014. I have provided below the email in its entirety as well as  links the FDA provided for anyone who is interested in what was discussed and for those who missed the meeting, as well as for those who may be interested in submitting comments. Please note the period to submit comments will close May 26, 2014.

As a fibromyalgia patient and advocate for change, I encourage everyone to please take a moment to review the meeting details as well as submit your comments and let your voices may be heard so that you too can make a difference. Your comments and efforts will be greatly appreciated!

Thank you! -JD

A Message from United States Food and Drug Administration

Dear fibromyalgia meeting attendees,

Thank you for attending the public meeting on fibromyalgia patient-focused drug development! FDA collected valuable information on fibromyalgia, the impact it has on patients’ lives, and patients’ perspectives on treatment options. We truly appreciate the courage, effort and time invested from everyone who was able to attend the meeting in person or on the web.

We know that not everyone who wanted to come to this meeting was able to attend. For anyone who missed the meeting or is interested in what was discussed, we have posted a full recording of the meeting on our website: http://www.fda.gov/forindustry/userfees/prescriptiondruguserfee/ucm363203.htm.

In addition to the input we gathered at the March 26 meeting, we encourage fibromyalgia patients, caregivers, and other stakeholders to submit written comments to the online public docket. The comment period closes on May 26, 2014. Submit your comments through this website: http://www.regulations.gov/#!documentDetail;D=FDA-2013-N-1041-0004.

FDA is particularly interested in hearing patients’ perspectives on the questions outlined in the Federal Register Notice that announced this meeting. These questions are pasted below for your reference, and the Federal Register Notice can be found here: https://www.federalregister.gov/articles/2013/09/23/2013-23019/fibromyalgia-public-meeting-on-patient-focused-drug-development.

Again, thank you to everyone who attended the March 26 meeting. If you have any questions, please email PatientFocused@fda.hhs.gov.

Discussion Questions

Topic 1: Disease symptoms and daily impacts that matter most to patients

1) Of all the symptoms that you experience because of your condition, which 1-3 symptoms have the most significant impact on your life? (Examples may include chronic pain, fatigue, difficulty concentrating, sleep disorders, etc.)

2) Are there specific activities that are important to you but that you cannot do at all or as fully as you would like because of your condition? (Examples of activities may include sleeping through the night, daily hygiene, driving, household chores, etc.)

a) How do your symptoms and their negative impacts affect your daily life on the best days? On the worst days?

3) How have your condition and its symptoms changed over time?

a) Do your symptoms come and go? If so, do you know of anything that makes your symptoms better? Worse?

4) What worries you most about your condition?

Topic 2: Patients’ perspectives on current approaches to treating fibromyalgia

1) What are you currently doing to help treat your condition or its symptoms? (Examples may include prescription medicines, over-the-counter products, and other therapies including non-drug therapies such as exercise.)

a) What specific symptoms do your treatments address?

b) How has your treatment regimen changed over time, and why?

2) How well does your current treatment regimen treat the most significant symptoms of your disease?

a) How well do these treatments improve your ability to do specific activities that are important to you in your daily life?

b) How well have these treatments worked for you as your condition has changed over time?

3) What are the most significant downsides to your current treatments, and how do they affect your daily life? (Examples of downsides may include bothersome side effects, going to the hospital for treatment, restrictions on driving, etc.)

4) What specific things would you look for in an ideal treatment for your condition?

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Dear NaNoWriMo and NaBloPoMo, Can There Be Such a Thing as NaNoWriDisMo and NaBloPoDisMo?

Dear NaNoWriMo and NaBloPoMo,I just learned from a BlogHer email that NaBloPoMo begins January 1, 2014 and the race is on for numerous people to participate in the upcoming NaBloPoMo event.

I thought, how fitting the timing since I was in the process of blogging about a small change I would like to see with NaNoWriMo and NaBloPoMo for those disabled but would like to be a part of this glorious event in the near future. As well as those who may have some difficulty participating given the requirements and writing challenges.

I am a person who has a compassion for all no matter what one suffers with. Granted it was not until after I became diagnosed with chronic pain syndrome after suffering with hand and elbow conditions, Fibromyalgia, and other conditions that I developed a greater compassion for those in pain and those who have become disabled as a result of their diagnosis. I empathize with ones who are limited in their capacity to function as they were accustomed to and know what it is like to face challenges or obstacles when desiring to be a part of the norm.

When I first began my blog, I didn’t realize the amount of time, effort, physical strength, and writing that would be required to maintain the blog. While I welcomed comments, sometimes it would take days, weeks, or longer periods for my response because of limitations with my hands but I no doubt would respond as time permitted. My writing also averaged minimally compared to other bloggers because of days that prevented me from posting due to excessively flared symptoms that kept me bed-ridden. But all I knew when my children introduced me to blogging and agreed to help me to encourage me and take me out of my comfort zone, I wanted nothing more than to connect with others and do something different even though my body was saying no.

As such, when I first heard of National Novel Writing Month (NaNoWriMo) I did not have any idea what was the world of NaNoWriting. As November approached, mid-way through my joining social media over a year ago, a friend of mine named Sezoni Whitfield, whom I met on social media who support writers in their projects and conduct writer interviews via WritersKaboodle on Twitter introduced me to the idea and asked if I were interested in participating.

I told her I had never heard of it, and given my limitations with my hands and elbows along with the pain and challenges I faced daily with what I considered severe symptoms of Fibromyalgia coupled with chronic pain, there was no way on earth I could ever begin to write every day to complete 50,000 words in one month. Even though I have managed to write a memoir that took me years to compile and is in its final stage awaiting final editing review, it in no way can compare to having to post every day and meet the 50,000 word challenge.

But then I had an afterthought and in response to that challenge, I decided to take a look at my blog posts and do a word count from November last month as well as posts from November 2012 and this is what my family and I came up with. In 11/2013 approximately 29,150 words were written and in 11/2012 approximately 38,843 words were written not towards a novel but just my thoughts on my blog.

Now, if I were to go and count I’m sure the words I wrote in my memoir would exceed 50,000 yet it was not done in a month as would be required if I chose to participate with NaNoWriMo in November. Therefore, prompting my idea for change.

I joined BlogHer a short time later in November and saw National Blog Posting Month (NaBlogPoMo). I decided to further research and after gaining insight I had a strong desire to participate but knew I couldn’t meet the challenge. A year went by with not much changing with my physical limitations but I was still interested in the possibility of participating. It was not until last month when I received an email from BlogHer noting the end of NaBloPoMo that again I wished I could have been a part of it. Sadly I couldn’t because the challenge was too great.

So I started thinking, what if NaNo (Writing Month) was to include a writing challenge in November for people with disabilities and gave them similar requirements that included 30 days with a lower word count of approximately 39,000 – 40,000 words. With the hope of writing something that doesn’t necessarily need to be a novel but can be smaller like an inspirational journal for publishing (NaNoWriMo). Additionally, the same requirement would apply for NaBlo (Posting Month) with the exception of creating inspirational blog posts for thirty days instead of writings towards a novel. And each entity called it National Novel Writing Disability Month (NaNoWriDisMo) or National Blog Post Disability Month (NaBloPoDisMo).

Granted, I know there will be a lot of variables to consider when making such a change and given the fact some people do not wish to be placed in a certain category, for me I feel those with disabilities would welcome the idea who face challenges but desire to be included. And it possibly may motivate and inspire them to meet the challenge along with others who participate in this worldwide event.

I am not one to view things in a light that would place labels on others nor do I wish it to be viewed this way but my hope is for others to see it as inclusiveness that would give equal accessibility to those we don’t know who may feel inadequate or incapable of participating and choose not to because of a disability, but desire to do so. I believe it would be exhilarating, freeing, empowering, and amazing!

Whew….now that I’ve gotten that off my chest, I feel better. And remember, these are just my thoughts. Thanks for listening. Be blessed! -JD

Signed,

Me
Future
NaNoWriDisMo and
NaBloPoDisMo member

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