...is fuck all. And it's fuck all, because the people who ought to be able to explain these things to me can't. Or won't. I've tried to believe that the system isn't as crooked as fuck, truly I have, but the numbers don't stack up. The argument that I am continually faced with is "these drugs work and are reasonably safe, because somebody else has said that that's true," and, usually, that other person is unavailable for comment (eg, Keller, Ryan, Dunner, Breckenridge, Woods, Benbow, etc, etc). I regret to say that when you've been where I've been, that argument doesn't fucking wash. I could have limited my reading to the fucking PIL, and been just as informed as I am now, well over a year into my research, and having tried to speak to every official source of information that I could (most of which decided that they had no obligation to speak to me, apparently).
I posted the following as a comment on a Pharmalot thread, about the Northern Illinois University shooter, Stephen Kazmierczak.
I’ll tell you what I know about SSRIs, and I would like to acknowledge that my own experience of them is negative (fluoxetine). Most of my comments will be about Paxil/Seroxat, though, seeing as I have seen one report that suggests the shooter was on that drug.
There are significant side effects with these drugs. We may regard this as a fact, not speculation based on a correlation between changes in behaviour, as against the taking of these drugs by those experiencing said behaviour. And we may regard it as fact, because the people who make them, and the people who regulate the manufacturers agree that it is so by producing a PIL. So let’s put that to bed: SSRIs DO cause suicidality, and homicidality (and withdrawal, and akathasia, and…).
Next, there is no evidence that the drugs work any better than placebo. Bald statement though that is, it appears to be a fact. The MHRA (the current UK regulator) was unable to explain to me what the benefit of Seroxat (Paxil) is. Neither was GSK, nor the Department of Health, nor the UK industry lobbying body, the ABPI. The fact that the drug is on the market does not appear to be evidence of its efficacy, then, given that the UK regulator at the time, the MCA, appears not to have chosen to scrutinize the original trials data that Glenmullen recently reported on.
If the drug has no efficacy, then no risk:benefit analysis can ever have been carried out, because there is no benefit against which to offset risks. I’m still waiting for somebody to explain how my logic is incorrect. The MHRA justified the continued presence of Seroxat on the pharmacists’ shelves by declaring that the drug was good, because the manufacturer had said so (what it actually said was that it’s decision to license the drug was based on a positive statistical analysis (provided by the manufacturer), backed up by peer-reviewed articles (the less said about those, the better)).
Now, we can get into a discussion about dodgy marketing, suppression of side effects, routine withholding of negative data, “information laundering” (due deference to Pharmalot, for coining this phrase) via KOLs and clinicians, bribery and corruption, if you like. However, the fact remains: the manufacturers and the regulators cannot explain how the drugs work (nor even how they were assessed), and they DO cause severe side effects - that’s a given. It’s on the PIL.
That some people are more severely impacted than others appears to be the case. That not every patient on these drugs goes out to a mall/high school/university campus and starts blasting away does not prove that the drugs are not to blame.
Matt
Addendum:
The term "information laundering" was coined by Clinical Psych, and not Pharmalot (please see post, below).
Sunday 17 February 2008
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