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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
I am happy to bring more knowledge to researcher about this crazy syndrome that baffles most.
When submitting comments they are most interested in the impact on your daily life. What can you no longer do that you used to do? What activities do you need assistance with? Have you been forced to stop working?
This is one of those "once in a lifetime" chances to be heard.
What about the idea that opiates don't work, and the difficulty getting them? Also, they have rejected one of the most promising drugs for sleep issues, xyrem? We at least need to be able to have the drugs that exist.
They specifically want to hear how it impacts your daily life, but certainly part of the impact for many people is due to the fact that treatments known to be helpful are not available. I personally have the quality of life that I have, and can exercise and do the other things recommended for our self care, because I have access to effective pain control.
http://www.fmcpaware.org/fibromyalgia/fda-december-10-2013-meeting.html
There are questions to be answered so you don't have to wonder what to write.
Thanks in advance!
http://www.fmcpaware.org/fibromyalgia/fda-december-10-2013-meeting.html
Thank you both for sharing this great information and yes we ALL need to open up and voice our feelings how this has changed our lives as it has wacked us hard, turning us unside down and sideways.
What say ya ladies and gent?
Readers Sound Off on FDAs Fibromyalgia Hearing
October 21st, 2013 by Pat Anson, Editor
Our story last week about a public hearing on fibromyalgia being planned by the Food and Drug Administration really resonated with National Pain Report readers so much so that many couldn't wait for the December hearing.
They shared their experiences with fibromyalgia online both here and on an FDA website writing about their frustration and disappointment dealing with pain, disability, insomnia, skeptical doctors and drugs that dont work.
Living with fibromyalgia is one of the most miserable and embarrassing experiences of my life, wrote Kathy Carris, a middle school teacher who wrote about the short term memory loss or brain fog that many fibromyalgia patients experience.
The most difficult part of this disease to cope with is the FOG. It is difficult to teach every day and be expected to be mentally acute when my brain will shut down without warning. I have been in the middle of talking about a topic and my brain stops. I cant remember what I just said or what I had been talking about moments before.
Mary Adams wrote that she suffered from fibromyalgia for years before being diagnosed.
I was baffled and completely overwhelmed as to why I was feeling so bad and why the pain I was feeling was excruciating all the time. Every doctor I went to told me it was all in my head, I was just depressed and put me on all those anti-depressants in hopes Id feel better. But the anti-depressants didn't help at all and just made me more ill, said Adams.
It would be safe to say that the majority of fibromyalgia patients are fed up with the doubts, stigma, jokes and labels, wrote Debra Van Ness, a registered nurse who has suffered from fibromyalgia for nine years.
We are not only stigmatized for this disease from hell, but some of us are stigmatized for the medications we need to have any semblance of normal life even temporarily. I am sick all over every single day of my life.
Fibromyalgia has stolen my life, wrote Jacki. I feel there has not been enough research into this disease, nor enough study into how to control the pain that we all live with. I feel our lives have been stolen from us all.
These are exactly the kind of comments the FDA wants to hear from fibromyalgia patients, according to Graham Thompson of the FDAs Center for Drug Evaluation and Research.
Were primarily concerned with getting actual patient input, Thompson told National Pain Report. Were not having physicians and doctors come to present studies, its more giving patients an opportunity to come and really share their own perspectives and their own stories.
You really get a good idea of how debilitating a disease is, and how much it effects peoples lives when you get to hear from them in person and go into detail on their symptoms, and what treatments theyve been trying to take.
The meeting will be held 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.
Fibromyalgia is one of 20 diseases the FDA is holding public hearings on under Patient-Focused Drug Development, an initiative that is part of the Prescription Drug User Fee Act.
Thompson is well aware that not everyone will be able to attend a meeting in the Washington DC area in the middle of December. And not everyone will be able to comment during a four hour public hearing that hundreds are expected to attend.
Thats why the FDA is encouraging fibromyalgia patients to comment on an online public docket that can be found at this link:
http://www.regulations.gov/#!documentDetail;D=FDA_FRDOC_0001-4219
Its absolutely crucial that we have a way for people who are unable to come and speak or if we cant accommodate everyone at the meeting to have a place for everyone to submit input, said Thompson. All the comments made in the public docket are considered part of the public record and factor in just as much as testimony during the meeting does.
The agency is looking for public comment on a broad range of issues involving fibromyalgia, from symptoms and treatments to lifestyle changes and side effects from medications.
We read each and every one of them and we analyze them and they are all incredibly helpful. The public comment is really crucial, says Thompson.
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. There is no known cure and many medications prescribed to treat fibromyalgia are ineffective.
Patients like Sheri New who was diagnosed with fibromyalgia 20 years ago believe more research is needed
At the time I was diagnosed, little was known about the disease and there were probably two books out that could even begin to describe what I was going through or what I could expect, wrote New.
The thing that scares me the most is that now I am 50 years old and after nearly 20 years of fighting, we are not much closer to a treatment let alone a cure.
(Editors Note: Many readers who saw our first story about the FDA hearing apparently thought the comments they posted on National Pain Report would be part of the public docket. While were always happy to hear from readers, the proper place to make those comments is at the link below)
http://www.regulations.gov/#!documentDetail;D=FDA_FRDOC_0001-4219
http://www.prohealth.com/fibromyalgia/library/showArticle.cfm?libid=18407&B1=EM102313F&utm_source=EM102313F&utm_medium=em&utm_campaign=FM&slvor=11310.1118344.0.1.0.383253&eid=sue@richmondfibro.org
There is still time to give the FDA comments..