Fibromyalgia patients report pain, fatigue and multiple therapies at FDA hearing

Chronic pain, fatigue, difficulty concentrating and sleep problems were the top symptoms discussed by patients with fibromyalgia during today’s FDA public meeting on patient-focused drug development.
The patients reported multimodal treatments that included FDA-approved and over-the-counter drugs, herbal remedies and exercise. Adverse events and high costs of treatments were concerns brought up by many in attendance.

The meeting was moderated by Sara Eggers, PhD, Office of Strategic Programs, Center for Drug Evaluation and Research (CDER), FDA.

Patient testimony was divided into two sessions. In the first session, five patients testified on disease symptoms and daily impacts that mattered most.

In a survey taken at the beginning of the hearing, the majority of the patients attending the hearing, in person and through a webinar, identified as between 30 to 60 years of age, with 80%-90% women. The majority of the patients reported having been diagnosed with fibromyalgia for more than 20 years.

Specific symptoms included:

Chronic pain, to the point that the patients fear becoming wheelchair-bound
Chronic fatigue. “The fatigue is not your normal tiredness,” one patient said.
Insomnia
Cognitive function, which some of the patients described as “fibrofog,” including not being able to recall words
Headache
Gastrointestinal issues

The patients described trying to follow a daily routine, including taking a variety of medications, and “trying to handle life and not get overwhelmed.”

A second session focused on patients’ perspectives on the approaches to treating fibromyalgia, including any downsides to treatments and how well current therapies were treating symptoms. Testimonials included patient advocates, who also happened to be patients with fibromyalgia.

Jan Chambers, president of the National Fibromyalgia & Chronic Pain Association, reported that she has had fibromyalgia for eight years and spent $100,000 to seek a diagnosis. “That did not include any answers as to what to do next,” Chambers said.

Another speaker reported that she had tried “an alphabet soup of [22] medications,” for her symptoms.

The adverse effects of prescription drugs including duloxetine (Cymbalta, Eli Lilly) and pregabalin (Lyrica, Pfizer) were discussed. Other treatments mentioned were anti-inflammatory herbs, including cumin and tamarack, and ibuprofen for flares. High-dose opioids were mentioned as effective by one couple for the husband’s treatment; however, they reported that their insurance company would no longer cover such therapy.

Social media sites were mentioned as a way for patients to communicate and cope with fibromyalgia symptoms.

“There’s never going to be a one size fits all for the [patient] population or potentially even to address … any one person’s symptoms,” Sharon Hertz, MD, deputy director, Division of Anesthesia, Analgesia and Addiction Products, CDER, FDA, said, regarding the heterogeneity of fibromyalgia symptoms.

Hertz also addressed patients’ concerns about labeling of side effects on FDA-approved drugs, telling them they could find the information on the agency’s website.

“We [FDA] do take a very serious look at all the information coming in as we are developing these drugs, and a lot of this information is available online,” Hertz said about the drugs. — By Bruce Thiel