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I have written a number of articles related to various violent rage-monster style attacks over the years in this column; Newtown, Aurora Colorado and others. These attacks, including others such as the infamous Columbine High School shoot-em-up-fest, have a common pair of thematic elements:
Correlation is not causation and the plural of anecdote is not data. However, the lack of such rage-monster incidents among other age groups, when these drugs are prescribed across the spectrum of ages, is extremely curious -- and troubling.
Now we have data, in the form of two studies. The first deals with an infamous Glaxo study known as "329", which was related to the drug Paxil; the US brought criminal charges against GSK and ultimately a $3 billion fine for its marketing of the drug to children and adolescents -- an "off-label" use that cannot be marketed under US law and which GSK claimed was supported by "remarkable efficacy and safety" demonstrated by this particular study.
The problem lies in what was found when the study data was re-analyzed -- specifically:
But according to the RIAT team, the effect of paroxetine was not significantly different from placebo for any prespecified primary or secondary outcome measure.
In other words the drug did not work.
In the CSR, serious adverse events (defined as an event that “resulted in hospitalization, was associated with suicidal gestures, or was described by the treating physician as serious”) were reported in 11 patients in the paroxetine group, five in the imipramine group, and two in the placebo group.
In other words the rate of serious adverse events including suicidal gestures was more than five times higher in the group receiving the drug than those receiving placebo -- on a drug that didn't work.
Has this paper been retracted? No. Has anyone gone to jail for what certainly appears to be impossible to explain away as "accident" or even "ordinary negligence"? No. How many young people are dead as a result and why aren't the people responsible for this under indictment as accessories before the fact on negligent manslaughter charges?
But if you think that is bad then you're really going to like this -- which also bears on SSRIs:
From Swedish national registers we extracted information on 856,493 individuals who were prescribed SSRIs, and subsequent violent crimes during 2006 through 2009. We used stratified Cox regression analyses to compare the rate of violent crime while individuals were prescribed these medications with the rate in the same individuals while not receiving medication. Adjustments were made for other psychotropic medications. Information on all medications was extracted from the Swedish Prescribed Drug Register, with complete national data on all dispensed medications. Information on violent crime convictions was extracted from the Swedish national crime register. Using within-individual models, there was an overall association between SSRIs and violent crime convictions (hazard ratio [HR] = 1.19, 95% CI 1.08–1.32, p < 0.001, absolute risk = 1.0%). With age stratification, there was a significant association between SSRIs and violent crime convictions for individuals aged 15 to 24 y (HR = 1.43, 95% CI 1.19–1.73, p < 0.001, absolute risk = 3.0%). However, there were no significant associations in those aged 25–34 y (HR = 1.20, 95% CI 0.95–1.52, p = 0.125, absolute risk = 1.6%), in those aged 35–44 y (HR = 1.06, 95% CI 0.83–1.35, p = 0.666, absolute risk = 1.2%), or in those aged 45 y or older (HR = 1.07, 95% CI 0.84–1.35, p = 0.594, absolute risk = 0.3%).
About 3% of the young people, that is, age 15-24, who were prescribed these drugs had a violent crime conviction that appears to be linked to them taking the drug -- a rate approximately double that of the next age cohort and double that of someone not consuming the drug at all.
There was no statistical increase, however, in older patients.
Considering the seriousness of violent offenses and the fact that this measures only convictions (and we know not everyone who does an evil thing gets caught or is convicted) this is an outrageous increase in risk, particularly when you combine it with the above study that appears to show that at least one of the drugs in this class is not effective in patients in this age group -- that is, it doesn't work.
So we have here a drug that appears, from these studies, to literally provide no benefit but it does create a material number of rage monsters.
Further, that the drug was worthless in terms of efficacy and was also dangerous was known long ago.
Oh, and it makes the companies that produce these drugs and the physicians that prescribe them billions of dollars too.
Exactly why aren't all of the executives associated with this and those who put together and published the original studies under indictment as accessories before the fact for those who have committed suicide -- or homicide -- while on drugs that appear to be worthless for the condition prescribed?
Come talk to me about how wonderful our medical and judicial systems are and why anyone in America should have respect for either of them when everyone involved in this crap has been brought to justice.
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