Fibromyalgia Support Group
You're not alone in your pain. Fibromyalgia is a condition that can be difficult to diagnose and manage. If you're trying to cope with pain throughout your body, sleep problems, general fatigue, or other common fibromyalgia symptoms, you're in the right place. The community is here for you to talk about therapies and share your challenges.
FDA Seeking Public Comments on Fibromyalgia
October 15th, 2013 by Pat Anson, Editor
What medications do you take to treat fibromyalgia? Do they work? How does fibromyalgia affect your daily life? Do your symptoms come and go?
6777243986_763e69f665_bThose are the type of questions the Food and Drug Administration is seeking answers to at a public hearing in December on fibromyalgia.
The hearing is intended to allow the FDA to obtain patients perspectives on the impact of fibromyalgia on their lives, as well as the effectiveness of therapies in treating it.
The National Institutes of Health estimates that 5 million Americans suffer from fibromyalgia, a poorly understood disorder characterized by deep tissue pain, fatigue, headaches, depression and lack of sleep. Many patients go for years before being diagnosed and medications to treat fibromyalgia are often found to be ineffective.
How much time has the FDA set aside to discuss this complex disorder? Four hours.
The agency does have its hands full and not just because of the government shutdown. Fibromyalgia is one of 20 diseases the FDA is seeking input on under Patient-Focused Drug Development, an initiative that is part of the fifth authorization of the Prescription Drug User Fee Act.
Although the public meeting was announced in late September, so far it has generated little attention, and many fibromyalgia patients and advocates are only now learning about it.
Golf Pass
The meeting will be held on December 10, 2013, from 1 pm to 5 pm at the FDAs White Oak Campus in Silver Spring, Maryland. Further information about the location and early registration can be found here.
If you are unable to attend the meeting in person, you can sign up online to view a webcast.
You can also submit your comments about fibromyalgia right now at this website. As of this writing, only two people had submitted comments.
I hope many will weigh in with their own thoughts, says Celeste Cooper, a retired nurse and fibromyalgia expert and advocate. We need numbers, a show of hands, and commitment to research that not only affects us, but generations to come. Our talent is our voice.
Cooper is hopeful that the public hearing will lead to new research and treatments for fibromyalgia.
There is significant evidence that fibromyalgia is a biological illness which affects multiple body systems. Medications currently available are only partially helpful for a small percentage of patients; it is time for unbiased pharmaceutical research. We need effective medications with fewer side effects. We need research on NEW medications, not re-branding strategies of old pharmaceuticals to boost sales and increase the cost to the patient, Cooper wrote in an email to National Pain Report.
National Pain Report
October 15th, 2013 by Pat Anson, Editor
What medications do you take to treat fibromyalgia? Do they work? How does fibromyalgia affect your daily life? Do your symptoms come and go?
6777243986_763e69f665_bThose are the type of questions the Food and Drug Administration is seeking answers to at a public hearing in December on fibromyalgia.
The hearing is intended to allow the FDA to obtain patients perspectives on the impact of fibromyalgia on their lives, as well as the effectiveness of therapies in treating it.
The National Institutes of Health estimates that 5 million Americans suffer from fibromyalgia, a poorly understood disorder characterized by deep tissue pain, fatigue, headaches, depression and lack of sleep. Many patients go for years before being diagnosed and medications to treat fibromyalgia are often found to be ineffective.
How much time has the FDA set aside to discuss this complex disorder? Four hours.
The agency does have its hands full and not just because of the government shutdown. Fibromyalgia is one of 20 diseases the FDA is seeking input on under Patient-Focused Drug Development, an initiative that is part of the fifth authorization of the Prescription Drug User Fee Act.
Although the public meeting was announced in late September, so far it has generated little attention, and many fibromyalgia patients and advocates are only now learning about it.
Golf Pass
The meeting will be held on December 10, 2013, from 1 pm to 5 pm at the FDAs White Oak Campus in Silver Spring, Maryland. Further information about the location and early registration can be found here.
If you are unable to attend the meeting in person, you can sign up online to view a webcast.
You can also submit your comments about fibromyalgia right now at this website. As of this writing, only two people had submitted comments.
I hope many will weigh in with their own thoughts, says Celeste Cooper, a retired nurse and fibromyalgia expert and advocate. We need numbers, a show of hands, and commitment to research that not only affects us, but generations to come. Our talent is our voice.
Cooper is hopeful that the public hearing will lead to new research and treatments for fibromyalgia.
There is significant evidence that fibromyalgia is a biological illness which affects multiple body systems. Medications currently available are only partially helpful for a small percentage of patients; it is time for unbiased pharmaceutical research. We need effective medications with fewer side effects. We need research on NEW medications, not re-branding strategies of old pharmaceuticals to boost sales and increase the cost to the patient, Cooper wrote in an email to National Pain Report.
National Pain Report
I would suggest that you write your response on your PC and cut and paste to the site, because I've seen the page be wonky a couple of times. The information they're looking for is below:
These are the questions the FDA is seeking answers for - this is the only information they care about for the purposes of this hearing.
There is no "question and answer" format so it's good to review the questions and maybe write your response out before you go to the comments page, then cut and paste.
You can also register to view a webcast of the meeting at the same link where you post comments.
THE FOLLOWING QUESTIONS ARE FROM THE FDA WEBSITE.
FDA Topic 1 questions: - Disease Symptoms and Daily Impacts that Matter Most to Patients
Of all the symptoms that you experience because of your condition, which 1-3 symptoms have the most signicant impact on your life? (Examples may include chronic pain, fatigue, difficulty concentrating, sleep issues, crawly skin etc.)
Are there specic 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.)
How do your symptoms and their negative affects impact your daily life on the best days?
On the worst days?
How have your condition and its symptoms changed over time?
Do your symptoms come and go? If so, do you know of anything that makes your symptoms better? Worse?
What worries you most about your condition?
FDA Topic 2 questions: - Patients' Perspectives on Current Approaches to Treating Fibromyalgia
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 or acupuncture.)
What specic symptoms do your treatments address?
How has your treatment regimen changed over time, and why?
How well does your current treatment regimen treat the most signicant symptoms of your disease?
How well do these treatments improve your ability to do specic activities that are important to you in your daily life?
How well have these treatments worked for you as your condition has changed over time?
What are the most signicant 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.)
What specic things would you look for in an ideal treatment for your condition?
Again, the link to post comments is:
http://www.regulations.gov/#!docume...
I encourage everyone on this board to give comments. This is one way we can be heard at the FDA level.
Fibro is more than just pain. Let them know how you feel everyday.
Thanks for listening
The FDA's questions are listed there - NFMCPA put the page up during the shutdown and they've left it up for convenience.
http://www.fmcpaware.org/fibromyalgia/fda-december-10-2013-meeting.html
She said no, they like their employees to be involved in the community. It does good and looks good for then too. She also offered to let me do any printing I need for events and other things if I write on things that they are sponsoring the events.
More than fair. Printing is expensive. I'm a happy employee ;-)
I had wanted to do more extensive comments, but brain fog got in the way. I had also wanted to sign up for the webcast but didn't notice the deadline.
Those of you who are going, please report back to us. Maybe someone can post it on Youtube. And thanks for going. Hope it brings us more help and understanding
I am blessed to be only 90 miles away and able to drive. Not sure what the weather is doing to do to flights, but the NFMCPA folks have come in early and are already there. I'm the last one in :)
The most I expect the weather to do is shrink the audience a bit, and as they had to reopen registration and get a bigger room, that's not a bad thing. There is a much better chance that I'll get to speak if there are a few less people there, and the huge registration already gave them an idea of the interest, even if some people don't make it because of the weather - which will be entirely understandable.
Think good thoughts - they're expecting 3-5 inches of snow in DC on Tuesday and we've already had a lot of ice in the area.