On April 19th, the Office of Fair Trading, a UK consumer-watchdog agency, accused GlaxoSmithKline of delaying competition with its antidepressant drug paroxetine (Brand name Paxil in the US, Seroxat in the UK) by paying generic manufacturers to delay making a generic version of paroxetine.
If this is true, it is not the first — or worst — bit of subterfuge surrounding paroxetine and other antidepressants. Before the FDA approves a drug, it requires scientific evidence demonstrating that the drug is reasonably safe and actually does what it claims to do. However, when results from clinical trials have shown that their drugs work no better than placebo (sugar pills), antidepressant manufacturers have often chosen not to publish those results, or have published the trials but doctored the results to make them look like the drugs actually do something more than the placebo does.
An example from a 2010 article in Psychotherapy and Psychosomatics that reviewed the published and unpublished research on antidepressants: In one review of 74 trials, “According to the FDA scientific reviews . . . , only 38 trials (51%) found positive drug/placebo differences and 37 were subsequently published. The FDA judged the remaining 36 studies to be either negative (24 studies) or questionable (12 studies) – that is, no difference on the primary outcome but significant findings on a secondary measure. Only 3 (8%) were published reporting negative results, while the remaining 33 were either not published (22 studies) or published as though they were positive (11 studies) in contradiction to the FDA conclusions. ” (italics mine)
The problem? Physicians use evidence from different sources, including published studies, to make treatment decisions. If most of the studies that find no difference between drug and placebo are left out of the analysis or dressed up to make them favor the drug, then the physicians make recommendations based on skewed data that grossly misrepresents the efficacy of antidepressants. Not only are countless people harmed by medication side effects, countless more may be harmed by thinking that their problems in life can be cured with a pill, or that they’re at the mercy of a “chemical imbalance” in their brain.
A whopping 11% of the general population now take an antidepressant. If the decision to prescribe the antidepressant is based on published data, which is skewed to show a greater treatment effect for antidepressants than is warranted, then our health care systems pay an awful lot of money to pharmaceutical manufacturers for medications that many times work not because of anything in the pill, but because the patient believes the pill will work (i.e., the placebo effect).
The authors of the aforementioned review conclude, “The reviewed findings argue for a reappraisal of the current recommended standard of care of depression.” In a “Prozac nation” that values quick-fixes and “a pill for every ill,” where direct-to-consumer marketing is relentless and irrational, such a reappraisal may be a long time in coming.