To fight this fuzziness, the Food and Drug Administration uses a standardized vocabulary to describe side effects and "adverse events." This lexicon is drawn from the Medical Dictionary for Regulatory Activities (MedDRA).
"It's like a thesaurus a physician or researcher can use to label symptoms of a patient taking a drug," says Kelly Simontacchi, a medical director at UCB, the company that invented Keppra. "This makes for consistency across clinical trials."
During patient visits and clinical trials, doctors and researchers can use MedDRA's 70,000-plus terms to describe symptoms and side effects. Still, something can be lost in translation. What I call "irritability," another patient or a doctor might call "dysfunctional anger." For a company trying to get a drug approved, the latter sounds a lot worse than the former, but patients and doctors may use more colloquial language.
"Why did you choose that term when other terms might also have been available?" asks Patrick Revelle, director of MedDRA's maintenance and support services organization, of the word choices made by researchers — many of whom receive funding from drug manufacturers. "Was it a conscious effort to obscure something? These are questions that regulatory authorities ask."
When Keppra was developed in the 1990s, MedDRA wasn't yet in use. In a previous classification system, Simontacchi says, "irritability" wasn't an option. "Nervousness" was.
You don't need a medical degree to understand that these words are different. Woody Allen, for example, seems nervous — indecisive and neurotic, but not threatening. The gun-toting cast of a Martin Scorcese movie, however, seems irritable.
"When patients in clinical studies are queried for side effects, their reports have to be fit into pre-established categories," Spencer says. "There's a little disconnect between clinical studies and what we see in practice."