Readers Sound Off on FDA’s Fibromyalgia Hearing

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 don’t work.

ucm242284“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 can’t 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 I’d 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 FDA’s Center for Drug Evaluation and Research.

“We’re primarily concerned with getting actual patient input,” Thompson told National Pain Report. “We’re not having physicians and doctors come to present studies, it’s 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 people’s lives when you get to hear from them in person and go into detail on their symptoms, and what treatments they’ve been trying to take.”

The meeting will be held December 10, 2013, from 1 pm to 5 pm at the FDA’s 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.

That’s 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.

“It’s absolutely crucial that we have a way for people who are unable to come and speak or if we can’t 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 we’re 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.

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7 Responses

  1. Debra Van Ness RN says:

    I want to add that until someone has a legal lawsuit regarding the discrimination against fibromyalgia patients, we may not get anywhere. We are discriminated against daily by society in general and the medical field.

  2. John Quintner says:

    @Celeste. There is no evidence to support your statement that “a plethora of comorbid disorders exacerbate and maintain the primary FM symptoms ….” More in the way of circular argument is not going to improve this parlous situation. I suspect that rheumatologists have lost interest in the condition and agree that both general physicians and primary care physicians have little to offer. My money would be on funding research into the epigenetic mechanisms that regulate stress response systems. When we better understand these mechanisms we may be able to target some fundamental problems in their regulation that “maintain the rage” in many of these sufferers.

  3. rain says:

    Please keep me informed and updated about any developments regarding these latest results and researches, they are beneficial to people who are suffering the many symptoms that come with the fibromyalgia which undoubtedly affects the individual’s quality of life.

  4. Larryk says:

    I had to go to a university, 4 hours away, in order to get a diagnosis. Even that was only done as a “last shot” to figure out what was going on. It took over 6 years for anyone to even try that. I went through at least 6 neurologist, the same amount of neurosurgeons, 3 mental health professionals, at least 7 pain management docs and countless physical therapists who wouldn’t touch me with a 10ft pole.

  5. Eva Jarvis says:

    I would like to see more specialists in this area. When I was diagnosed I was given a piece of paper with some symptoms on it and was told, “Sorry, we know little about this except that it causes pain.” I have found no specialists in my state of N.H. and even if there is cost is always an issue. Doctors don’t like to prescribe pain medicine and the meds they have for this disease (Lyrica) do not work. I have been prescribed so many “new” drugs and most only treat one symptom. They actually caused more than they are worth. We need awareness. This is such a humiliating Disease because we don’t look sick. Doctors need to start listening to us, they are not God because they hold a degree. I hope this meeting can bring awareness and more specialists to this field.

  6. I have my ticket and have sent a direct comment via email and on the site. This research is encouraging and hopefully, the FDA understands how the plethora of comorbid disorders exacerbate and maintain the primary FM symptoms, disordered sleep (fatigue), cognitive deficit, and body-wide pain. It is difficult to expect a physician who specializes in general medicine to diagnose and treat FM as rheumatologists are suggesting, especially since rheumatologists do not agree on basic issues such as the need for a physical exam, or recognition that the symptoms attached to the end of the new criteria are not poly-symptom complaints, but instead point to common disorders that exist at a higher incidence in FM. When comorbid disorders are not diagnosed and primary symptoms are not considered and treated (particularly sleep) the patient has no chance of improving their symptoms.

    Celeste Cooper, RN, FM Sharecare expert, patient

  7. LarryK says:

    I hope this is a step in the right direction. I can’t attend in person but, I did reserve an online ticket. I’m eager to see how this plays out. It would be nice to see a multi day panel on the subject. However, this is a good start. Hopefully we can see more events like this for fibro.

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