Clinical Research: Phase 1 - Phase 4

Fighting the Placebo Effect in Fibromyalgia Drug Trials

Placebo response is an ever-present threat in analgesia clinical trials, and failure to sufficiently prove the efficacy of the researched compound can easily doom your promising new product. The risk can be especially pronounced when studying drugs to treat fibromyalgia.

Fibromyalgia patients can be — and don’t use the term casually or critically — needy. They have every right to be. After getting a lot of attention surrounding approvals about a decade ago, the research nearly dropped off the pharmaceutical map. As recently as half a dozen years ago, some physicians didn’t even recognize it as a real medical condition, even as studies began to surge back to address the remaining unmet needs.

But to those afflicted, it’s very real, manifesting itself in dozens of recognized symptoms from which patients historically have found little relief. Sufferers who long went undiagnosed — or worse yet were casually dismissed (“it’s all in your head”) — tend to appreciate the concern and attention they receive. Thus, these patients may:

  • Have unrealistically high hopes and expectations around the study compound’s efficacy.
  • Be easily influenced by environmental or staff perceptions.
  • Feel pressure, if only subconsciously, to please the trial staffers they see as their new allies.

On that last point, some fibromyalgia patients tend to become attached to study staff, and that attachment can cloud their ability to objectively report their response to treatment. Thus, it’s important that study sites actively to build distance by rotating staff starting early in the trial. Some studies have implemented site and patient training specifically to address this need.

Another complicating factor is the heavy consumer marketing of fibromyalgia drugs. You don’t have to be a TV addict to have seen many commercials for these products — indeed, we’ve seen many errant self-diagnoses by people who attribute their various ills and aches to the disease. This can skew patients’ impressions of the condition even to the extent of shaping their expectations of what new treatments may be capable of. Exposed to so much marketing, they may assume the medical community has fibromyalgia pretty much figured out, and that any new treatment may be just an iterative improvement on what already exists.

If you’re interested in more info on the placebo effect, make sure to check out our Placebo Problem series.