Dozens of fibromyalgia sufferers -– some of them in tears -– told a Food and Drug Administration panel today that many of the drugs and treatments they take for the disorder don’t work, leaving them fatigued, depressed and in chronic pain.
The FDA’s public hearing in Silver Springs, Maryland was held to get input from patients about the impact of fibromyalgia on their daily lives and the currently available therapies to treat the condition.
“I’ve experienced more types of pain that I’ve ever known a body can create, I have pain 24/7,” said Lori Galpeer, who has suffered from fibromyalgia for 18 years. She said her pain is so bad at times she “wants to rip my skin off.”
“My worst fear is that I’ll have to live the rest of my life this way,” Galpeer told the panel. “On my bad days, if the world fell apart, I would not care. Sometimes I’m too tired to even take a nighttime shower.
The National Institutes of Health estimates that 5 million Americans suffer from fibromyalgia, a poorly understood disorder characterized by chronic deep tissue pain, fatigue, headaches, depression, anxiety, and lack of sleep. There is no known cure and the disorder is difficult to treat.
The FDA has approved only three prescription drugs – Lyrica, Cymbalta and Savella – to treat fibromyalgia. But many patients who’ve tried them say the medications don’t work or cause intolerable side effects.
“Lyrica made me sleepy, stupid and angry,” said Sue. “Cymbalta after six days gave me reduced vision.”
“Savella was wonderful for the pain, but after a year of soldiering through it, I felt like Groundhog Day in the first trimester of pregnancy. I had morning sickness every day. It was like a year of continuing morning sickness.
“I’m on Cymbalta and that helps and gives me energy,” said Gwenn Herman, who has suffered from fibromyalgia for 19 years.
“I have gained a lot of weight. Some of the medicines put weight on me unbelievably. And then I have to decide what the pros and cons are.”
Herman, like many other fibromyalgia sufferers, also uses non-conventional therapies such as Chinese medicine, acupuncture, heating pads, lotions and even crossword puzzles – to treat her “brain fog”.
“The downside is my current treatment regimen does not make the pain go away,” said Herman. “I have pain 24 hours a day and I’m still looking for something to give me a better quality of life.”
Nancy Ryan said she’s tried so many different therapies she felt like a “human guinea pig”.
“I found the FDA approved drugs Lyrica and Cymbalta cause more problems and didn’t alleviate the pain,” said Ryan. “Lyrica addressed sleep, but it did this too well. I felt like a walking zombie and wanted to sleep all the time and had no motivation. It did not address my pain at all.”
Ryan said it would be “a tall order” for any drug to address the multiple symptoms caused by fibromyalgia and the different ways it effects patients.
“There is no plain vanilla fibromyalgia patient. We are a Baskin and Robbins array of varied symptoms and presentations. To expect there to be one medication that will address all of the symptoms of this diverse population is naïve,” said Ryan.
“Fibromyalgia researchers do not appear to have generated scientifically acceptable and testable hypothesis of causation. Until efforts are directed to this very important matter, fibromyalgia research will continue to remain in a state of limbo and treatment will continue to be hit or miss.”
FDA officials acknowledged that many of the current drug therapies for fibromyalgia are ineffective.
“We recognize that those have limited utility and don’t work for all patients. And so we want to hear about that as well, which drugs are working for you and which are not, and what ways they are working or not working. Some drugs work fairly well generally for people with a particular disorder and others only work for small subpopulations,” said Bob Rappaport, MD, Director of the FDA’s Division of Anesthesia, Analgesia, and Addiction Products.
Fibromyalgia patients can still submit statements to the FDA until May 26, 2014. To submit your comments, go to: http://www.regulations.gov/#!documentDetail;D=FDA-2013-N-1041-0004.
Fibromyalgia sufferers are also invited to participate in an online survey asking patients about the quality of their treatment and whether the drugs they’ve taken are effective. The survey is being conducted by the National Pain Foundation. The results will be available on the National Pain Report in mid-April.