On Tuesday, I stopped by a U.S. Food and Drug Committee advisory committee for Human Genome Sciences’ lupus drug, Benlysta. Though no two panels are ever completely alike, this particular meeting stood apart. Though the agency always allows for public comment, the FDA — for Benlysta — scheduled and hour-and-a-half for speakers from the public. That’s significantly longer than is usually allow for such presentations.
But a series of patients and advocates, each of them speaking for no longer than 5 minutes, managed to fill that expanded time without any problem. It was an emotional session, a parade of patients, each of which expanded on the ways that lupus had touched them: the pain, the impact on mental health, the loss of the ability to bear children. It was gripping, emotional stuff. And though it’s impossible to determine exactly what swayed the panel, Benlysta did get an overwhelmingly positive recommendation for approval from the committee.
It was a potent reminder of the emotional punch of patient stories, but — as the cliche goes — the plural of “anecdote” is not “data.” That doesn’t mean that testimonials are not convincing, but they lack impact unless they are supported by strong clinical data. The literature is full of stories of logic-defying medical miracles that turn out to be placebo effects; a single extraordinary story, cleaved from context, has only limited power to change minds.
The lesson of the Benlysta panel for storytellers, then, is not that patient experiences alone can win hearts and minds. Stories are only effective when they illustrate larger truths. This week, that larger truth was the seriousness of lupus, which has — for years — been such sufficiently tricky diagnosis that it has spawned its own House, MD meme. The Benlysta data demonstrated exactly what, scientifically, a drug could do for a condition. The patients put that data into perspective. Both halves were needed. Kudos, then, to both the patients, who bravely told their personal stories, and the FDA, which gave them the chance.