Glaxo Testing Paxil on 7 Year Olds
Another Bnet link via Beyond Meds, an increasingly reliable pairing for getting me infuriated about the state of a pharmaceutical industry virtually devoid of ethics.
It was established years ago thatPaxil carries a risk of suicide in children and teens, butGlaxoSmithKline (GSK) has for the last 18 months been conducting a study of the antidepressant in kids as young as seven — in Japan…
The drug carries a “black box” warning on its patient information sheet, warning doctors and consumers that the antidepressant is twice as likely to generate lethal thoughts than a placebo…
Paxil is being tested against a placebo, so the results won’t be very surprising — even terrible drugs work better than sugar pills.
To what degree Paxil triggers suicide is only a secondary aim of the study. If the results suggest a lower suicide risk, expect GSK to play them up. If they’re bad, expect the company to dismiss them in favor of the primary endpoint results.
About 130 children have been enrolled, according to ClinicalTrials.gov, which puts about 65 patients in each arm. That means the results won’t be too statistically robust — there only need to be two or three outlier results to skew the numbers by several percentage points.
When do we reach the limit? When is enough enough? For all the talk of evidence based practice and apparently wiping out the need to scientifically determine things like the chemical imbalance these drugs are sold to “correct”, how is it somehow not enough that real world evidence shows Paxil in particular and drugs like it have terrible outcomes in a lot of people and markedly more so in children? On top of that we have the studies showing that the only effects SSRIs are known to have in appreciably greater amounts than placebo are the negative effects. The kids have already been guinea pigs long enough for use to know the results are not good and certainly not controllable.
It’s gotten to the point that when you see a child in the news that kills himself strangely young and seemingly out of nowhere or shoots his classmates or kills his parents, you can all but assume that child is on antidepressants. Those are the increasingly predictable behaviors that have earned this class of drugs their little black box. We need to realize that we are putting children on mind altering drugs and unless we know precisely how they work, we have no say over how these forming minds will be altered — here or in Japan.
Entry filed under: Pharma. Tags: Antidepressants, Beyond Meds, Bnet, Children, Ethics, Glaxo, GlaxoSmithKline, GSK, Japan, Mental Health, Mental Illness, Paxil, Pharma, Pharmaceuticals, Placebo, Psychiatry, SSRI, Suicide.