An untold story?BMJ 2008; 336 doi: https://doi.org/10.1136/bmj.39504.662685.0F (Published 06 March 2008) Cite this as: BMJ 2008;336:532
- Jeanne Lenzer, medical investigative journalist, New York, firstname.lastname@example.org,
- Shannon Brownlee, senior fellow, New America Foundation, Washington, DC, email@example.com
New generation antidepressants aren’t all they’re cracked up to be. That seems to be the central message in the meta-analysis published this week by Irving Kirsch and colleagues in PLoS-Medicine,1 and it was this message that made the headlines. Kirsch’s conclusion follows on the heels of similar studies showing that statins are useful in only a small subset of patients taking the drugs2 and earlier studies showing that the safety and performance of cyclo-oxygenase-2 inhibitors seemed better than proved to be the case,3 further reinforcing previous criticisms that regulators in the United Kingdom and the United States are not doing their duty to protect the public from useless and dangerous drugs. But there’s another, deeper problem here—a problem that, ironically enough, was highlighted by GlaxoSmithKline’s news release stating that Kirsch’s conclusions are “incorrect” because he evaluated only a “small subset of the total data available.” How can regulators, the public, and doctors know how useful (or how potentially dangerous) drugs really are unless outside researchers have access to all the data?
The gist of the new study’s findings is that analysis of published and unpublished data from studies of antidepressants in adults shows that only a very small subset of patients seemed to benefit. Antidepressants “failed to separate” from placebo in almost all instances except among a subset of severely depressed patients. That subset of a subset comprised severely depressed patients—those who scored 23 or higher on the Hamilton rating scale of depression (HRSD). Other studies have found different problems with the antidepressants. Recently the US Food and Drug Administration found safety problems—roughly a doubling of …
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