Built on a Fragile Foundation
Was the Original Botox Cosmetic Approval Based on Enough Evidence? Walk into any pristine medspa from Fort Worth to Los Angeles, and you'll find a quiet confidence in the air. It’s a confidence shared by both the provider and the patient—the unspoken assumption that the treatments offered, especially one as ubiquitous as Botox , have been tested for years, on thousands of people, and deemed unequivocally safe for long-term use by the highest authorities. We assume the FDA has done the exhaustive, multi-decade work for us. We trust the system. That assumption, for Botox Cosmetic , is a dangerous illusion built on a surprisingly fragile foundation. The truth is that the 2002 FDA approval that unleashed this neurotoxin as a cosmetic blockbuster was based on the combined data from two nearly identical studies, which together included just 405 people who received Botox, tracked for only four months. The main goal of these studies was not to discover rare, long-term, systemic risks, bu...