What Your doctor was Never Told about Psychiatric Drugs
For decades, doctors were trained on a version of psychiatric drug data that had been filtered, reframed, and in some cases ghostwritten. The full record tells a different story. In the early 1990s, a drug called Paxil was being taught to American doctors as a breakthrough. Cleaner than older antidepressants. Safer. More precise. The science, they were told, was settled. It wasn't. And the evidence for that was sitting inside the FDA's own files -- available through the Freedom of Information Act -- for anyone who knew to look. When a pharmaceutical company seeks approval for a psychiatric drug, it submits its complete clinical trial data to the FDA -- not summaries, not press releases, the raw results. These are documents the public almost never sees. In the late 1990s, psychologist Irving Kirsch used the Freedom of Information Act to obtain the FDA's complete trial records for the most widely prescribed antidepressants in America: Prozac, Paxil, Zoloft, Celexa, and Effexor. What he found was not what doctors were being taught: ~50% of submitted antidepressant trials failed to show benefit over placebo 1.8 pts average drug–placebo difference on depression rating scale (3 pts = clinically perceptible) 75–80% of improvement in trials occurred in the placebo group, not the drug group The FDA reviewers noticed. On Paxil, an FDA medical reviewer wrote that the drug showed minimal improvement over placebo. In a Prozac FDA statistical review, the clinical significance of the observed difference was questioned. On Celexa, a reviewer wrote that the effect size is small. That language exists in the approval documents. It was not transmitted to medical schools. "Many trials failed. Average benefits were small. Placebo did most of the work. Clinical relevance was questioned by FDA scientists themselves. And yet doctors were taught that antidepressants correct a chemical imbalance." In 1998, GlaxoSmithKline completed a clinical trial testing Paxil in adolescents. The trial had a number: Study 329. The data were unambiguous -- the drug failed to outperform placebo on its primary measures, and adolescents on Paxil experienced significantly higher rates of suicidal thoughts and attempts.