Category: Health and Wellness
It was established years ago that Paxil carries a risk of suicide in children and teens, but GlaxoSmithKline (GSK) has for the last 18 months been conducting a study of the antidepressant in kids as young as seven — in Japan. It’s not clear why the company would want to draw more attention to its already controversial pill, but it appears as if GSK might be hoping to see a reduced suicide risk in a small population of users — a result the company could use to cast doubt on the Paxil-equals-teen-suicide meme that dominates discussion of the drug.
GSK didn’t immediately respond to a request for comment. A staffer on GSK’s trials hotline confirmed the study was ongoing, however. 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.
The trial criteria listed on ClinicalTrials.gov, however, provide an interesting lesson in how managers can carefully design drug trials designed to flatter their products — something good companies don’t do.
The primary aim of the study is not to find out why Paxil makes some children kill themselves. Rather, it’s yet another efficacy study, which the drug doesn’t need because it was approved years ago — we already know the drug works.
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.
The trial will wrap up in September.
Not only do I blame the company for such unethical behaviour, but what's wrong with these parents that they're putting their children on such heavy drugs at such a young age instead of trying to get to the cause of the problem? They're Japanese so should really know better! Whatever happened to meditation, discipline, balance of the mind and body etc and simply using their brains to figure things out?
I think the person being experimented should be able to fully understand what they're getting into. In this case, I don't think parents should be able to make this decision, because many heavy drugs can have life-long effects. I know I would be very angry with my parents if they enrolled me in such an experiment at that age, at least when I was old enough to understand what it involved. There are some very exceptional seven-year-olds, but I know I wouldn't have understood an experiment like this at that age.
Correct me if I'm wrong, but weren't antidepressant type meds originally intended strictly for adults? Now I worked with a guy who worked with kids with various mental problems one summer, and he told me these kids were like night vs day w/o vs w their meds. However some of these kids had fetal alcohol (or narcotics use) spectal disorder, and some of these meds were to control seizure, not stabilize moods. I know kids can be used as research subjects w their parents' consent, but I don't think I'd consent to their participation in a study like this. Also, could it be the disposition of the individuals, at least with adults, that leads to depression or suicide rather than the Paxil? I took Paxil at one time and found it helpful. The dosage was gradually increased. I don't think individuals who aren't prone to depression would even be put on it, and might not the individual have been prone to suicidal thoughts with or without it?
I took that shit as an eleven year old and it made me sick
It really has different effects on different people. The best thing is to test small doses, one medication at a time, of course, and find what's best for you.