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.
Via online registration, I was part the webcast meeting of the FDA for fibromyalgia drug development. It was riveting-- the fact that finally there is this recognition and that the FDA is soliciting patient feedback for a very difficult disease.
Patients' stories were all heart-rending. I could relate to almost all the symptoms, many much more severe than I suffer.
One person spent over $100k just to get a diagnosis (and I sweat the $25 co-pay).
Very touching story by a Chicago cop (loved her accent) who developed fibro from work related injuries (funny stories but not funny outcomes). I could relate to her trajectory: unemployment, disability, divorcing husband,
I think I saw the Daily Strength FM poster who writes about naltrexone...forgot her moniker but it was neat to hear her and almost see her face.
the FDA repeatedly polled the participants about which symptoms were the most troubling. Big surprise (not) : Pain, fatigue and choose from the big list: sleep, anxiety & depression, etc. etc. I thought it was kind of dumb waste of time. Like they didn't believe what the research is? or what patients have been saying (that pain, fatigue, etc are not fully relieved despite FDA approved drugs for fibro?)
Medical marijuana wasn't mentioned by participants, possibly because they were sitting at a federal agency and were too scared to mention it. I did online as it is helpful for severe muscle pain for me and for muscle spasms for MS folks. Nor did the FDA bring it up.
There were at least three, almost apologetic, mentions of opioid therapy as being excellent for pain relief with few side effects (except one participant said it made her high).
FDA wanted to know about the side effects of the (only) FDA approved drugs for fibromyalgia (Savella, Cymbalta, Lyrica). Their efficacy is only poor-fair and the side effects are huge. The leaders of several groups gave meaningful details on these matters.
Did any of you see the webcast? What did you think of it?
Patients' stories were all heart-rending. I could relate to almost all the symptoms, many much more severe than I suffer.
One person spent over $100k just to get a diagnosis (and I sweat the $25 co-pay).
Very touching story by a Chicago cop (loved her accent) who developed fibro from work related injuries (funny stories but not funny outcomes). I could relate to her trajectory: unemployment, disability, divorcing husband,
I think I saw the Daily Strength FM poster who writes about naltrexone...forgot her moniker but it was neat to hear her and almost see her face.
the FDA repeatedly polled the participants about which symptoms were the most troubling. Big surprise (not) : Pain, fatigue and choose from the big list: sleep, anxiety & depression, etc. etc. I thought it was kind of dumb waste of time. Like they didn't believe what the research is? or what patients have been saying (that pain, fatigue, etc are not fully relieved despite FDA approved drugs for fibro?)
Medical marijuana wasn't mentioned by participants, possibly because they were sitting at a federal agency and were too scared to mention it. I did online as it is helpful for severe muscle pain for me and for muscle spasms for MS folks. Nor did the FDA bring it up.
There were at least three, almost apologetic, mentions of opioid therapy as being excellent for pain relief with few side effects (except one participant said it made her high).
FDA wanted to know about the side effects of the (only) FDA approved drugs for fibromyalgia (Savella, Cymbalta, Lyrica). Their efficacy is only poor-fair and the side effects are huge. The leaders of several groups gave meaningful details on these matters.
Did any of you see the webcast? What did you think of it?
Tomorrow I'll give you my impressions as I got to talk to a number of people including FDA and patient panel members and others who spoke.
For those on the webcast, could you see the room, or just the slides?
The webcast was broken into about 5 separate screens, with a live transcript, a camera view of the room taken from a long distance and not close up enough to see faces.
The whole thing will become a document which I'll post here online when (months?) it is available.
Re: naltrexone. The participant said only that it was effective and replication studies needed to be done.
http://www.healio.com/rheumatology/fibromyalgia/news/online/%7Badd9d41e-6481-482c-b5e4-83ebdc98caa9%7D/fibromyalgia-patients-report-pain-fatigue-sleep-problems-at-fda-public-hearing
Am looking forward to PeaceN2You's report on the meeting!
Susan
Like the rest of you, I'm looking forward to what Peace shares too
In the meantime, FYI the FDA's public comment period runs through May 26, and they're interested in hearing about anything and everything you want to tell them. They're particularly interested in your answers to the questions covered in the hearing, but they really want to hear from as many people as possible. The link is in the article that Shakota6 posted, down toward the bottom.
Also FYI, the "Sue" mentioned in that article was me. Not sure why they didn't use my last name, but I think it was probably because the other people they quoted were all panel members who had signed releases in advance, and I was the one person out of all of the others who spoke that they decided to quote, and they had no release from me or the others.
I'll write more when I've decompressed a bit.
From a purely personal perspective, it was an exhausting day. I picked up my son at 9:00 a.m. and we set out for Silver Spring, Maryland, a two-hour drive if there was no such thing as Beltway traffic. We managed to get lost once, but we still made the trip in less than three hours, which is fantastic for a trip that involves the Beltway. The trip home was similar the rush hour on the Beltway never quite seems to stop and we arrived home right at 10:00 p.m. In between there was a four-hour hearing, and then dinner with other attendees before heading back. I had to be at work at 8:00 a.m. on Thursday, so I didnt really get a break until the work week ended. Exhausting, but very worthwhile.
I was among the patient/patient advocate attendees, and we were at the table with Jan Chambers and other representatives from the National Fibromyalgia and Chronic Pain Association. I was doing dual duty representing both my local association and NFMCPA.
The day was structured in several parts, with the first being an overview of the day, and from there it moved quickly into the first patient panel. I was immediately impressed that one of the panelists, all of whom had originally been scheduled to testify at the December 10 hearing, was in a severe flare, and was allowed to attend and testify from her home, via the wonders of modern technology. The FDA folks said they had never done that before, and what impressed me was that they put themselves out to make it work for this panelist, rather than simply say oh well, too bad, as they could have done.
The first panelists testified on their symptoms and the impact on their lives. The panelists were all extremely articulate in their testimony. Their stories were as varied as any you will ever encounter, with the most poignant (for me) being the woman who was in too much pain to attend, who fought tears through most of her testimony. The most interesting was the former big-city police officer who had been injured on the job three times in nine months, with the end result being chronic pain that left her only able to walk with assistance. She told her story with both grace and an ironic sense of humor, and had the whole room hanging on her every word. The symptoms were no surprise, with the majority being the ones were all familiar with chronic pain, migraines, fatigue, IBS, and sleep issues.
The second panel testified about their treatments, including both current and past treatments, speaking about what worked, and didnt work, for them as individuals. The treatment regimens disclosed a continuum from only natural means of treatment such as supplements, herbal remedies, and exercise, to one person who testified to taking (as I recall) 18 pills each day, including anti-depressants and hydrocodone. The panelists perspective as to the current effectiveness of their treatment ran along a similar continuum, from those who felt their pain was well-managed, to those who were seeking different answers, but were hanging in with the current treatment, as they had tried pretty much everything available and were doing as well as they knew how on their current regimen.
In between the first and second panels, there was a moderated discussion on the same topic the panelists testified on symptoms and impact on lives. Many of the attendees spoke, and the FDA panelists listened intently, and asked follow-up questions that showed they were not only listening, but absorbing the information they were being given.
After the second panel concluded, a second moderated discussion took place, on the topic of the second panel, treatments, side effects, and what worked and what didnt. Again, many people spoke (I would estimate about 20), and like the panel, the treatment regimens disclosed by the attendees ran along a continuum from the all-natural to an extremely high-dose hydrocodone regimen.
Panelists included Jan Chambers, President of the National Fibromyalgia and Chronic Pain Association, and Gwenn Herman, Executive Director of Pain Connection, both of whom are also fibromyalgia patients. The other panelists were fibromyalgia patients who volunteered and were chosen from the large group that registered for the December 10 hearing that was rescheduled due to inclement weather.
Attendees included both patients and physicians, as well as advocates and family members. I didnt think I talked that much, but at the end of the day, when I approached Dr. Sara Eggers to thank her and the other FDA attendees for listening, she knew my name. It wasnt just my nametag, because my full name isnt the name I go by, and she called me by the name I go by rather than what was written on my nametag. SoI guess I said a few things :)
After the meeting we had dinner with the NFMCPA representatives and one of the physicians in attendance, and everyone agreed that the meeting had gone well.
There will be a transcript published that will be available on the FDA website, as the entire hearing is public, and everything said will become part of the public record. Reading about it will be a bit dryer than being there, hearing the voices, and seeing the faces, but it will also give you complete, word-for-word documentation of everything that happened and everything that was said during the hearing. Im not sure what the timetable is for that, but when I hear anything, Ill let you know.
There will also be a report written by the panelists, but that wont even be started until after the public comment period ends on May 26, 2014, so it may be mid or late summer before we see that. Im not sure where and how that will be published, but Ill pass on what I hear, when I hear it.
If anybody has any questions Ill be happy to respond sorry it took me so long to put this together.