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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
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/#!documentDetail;D=FDA_FRDOC_0001-4219
Sure we all have pain - that's the first symptom - but we also have so many other issues and they are not focusing on those at all because they have defined fibro solely as a pain condition.
That's why it's really important that people comment, and that they hear and see how diverse we are when you look past just the pain. We need comprehensive research - maybe if they got past thinking it was JUST pain, we'd have better research and better answers.
Thanks to those of you who have commented, will comment, and who share this information with others who will comment.
One more point - this is for "patients" only - very specific to patients. It's wonderful to hear from other people - our supporters, but in this hearing they are all about hearing from the patients - us.
Thanks again - and please do share this with anyone you know who has fibromyalgia and who might be willing to share their story.
The FDA and other organizations are actually assisting those who are testifying in person so that they can be prepared to make the points and get across the information that they want and need to talk about.
I'll be attending. If anyone wants to watch via live webinar you can register through the same link where comments are being taken.
How great is it to be able to help by sitting in front of our computers, which we do anyway?
Hoping to take a carload of people with me as they really need to see how many people care.
Yes all comments including written will become part of the public record of the hearing - so clarity is critical as is being comfortable with what you're putting out there.
I don't expect to be speaking although I'll go prepared. Speakers are being chosen from among the many who registered, and if there is time when the chosen speakers are done, others from the floor might get to say a few words. They've only allotted four hours - not enough but I'm just grateful someone is listening.
I wish the FDA would test these drugs a lot longer before they are approved because so far all of them have such horrible side effects.
I'm sick of being a guinea pig. Perhaps they could put money towards a cure instead of a magic pill.
With an estimated 12 million fibromyalgia patients we can probably do better than that.
This is a once-in-a-lifetime chance to actually have an impact on how fibromyalgia is viewed, and the results will probably last for our lifetime because they've never done this before, and we don't know if they'll ever do it again.
The results of this meeting and the comments received will determine the course of research, drug therapy, and many other issues not necessarily related to what most (incorrectly) see as the FDA's only work - approving drugs.
Fibromyalgia is currently defined as a pain disorder, and we all know it's so much more. That's why you only see research and new meds focused on pain - because that's what they know of fibromyalgia.
This is our chance to change the landscape both for ourselves and for every fibromyalgia patient.
Is the only place to give comments is the small space at the end of the questions.
My computer will not let me click in the space just behind the question.
As ya'll know from reading my posts I can go on and on and on.
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