As it happens, I received two related news reports from colleagues today. Both concern the current state of affairs with psychotropic drug research, and the dangerous ways in which data is being manipulated and misrepresented.
Huffington Post Live is launching a 15-part (!) expose by Stephen Brill about the active promotion of the antipsychotic drug Risperdal in past years (by J&J subsidiary Janssen Pharmaceutics) toward populations whom the FDA had legislated could not be targeted—namely adolescents and older people living with dementia. Here’s the introductory segment: http://huff.lv/1LAE1o1
In spite of poor evidence of efficacy and positive evidence of harm, Janssen actively promoted this drug to both populations in an attempt to create a billion-dollar market in the wake of their drug Haldol going generic. Distortion of data on both efficacy and harm led to as much as 60% of their medication going to these two contraindicated populations.
And this may be just the tip of the iceberg. Although risperidone has more recently become available as a generic, first Seroquel and then Abilify saw skyrocketing sales over the past decade. It is possible that continued manipulation of data and employment of sales tactics that suggest (nudge, nudge, wink, wink) that these drugs might be efficacious—even though not FDA-approved—continues to fuel the dangerous rise in the use of this entire class of medications.
The number two selling drug in the US during the first six months of 2015 was the antipsychotic drug Abilify—over $7 billion in sales. And the relatively stable number of people with schizophrenia does not account for the rise in the use of these pills.
These drugs are also being used in increasing numbers in adolescents for a variety of diagnosed “behavioral disorders”; and a recent report in The Guardian suggests they are similarly “enjoying” expanded use in people with developmental disabilities (http://www.theguardian.com/society/2015/sep/01/antipsychotic-drugs-may-be-used-as-chemical-cosh-to-control-behaviour) (once again, with no evidence of benefit).
On the “omission” side, a new report from the University of Adelaide published in yesterday’s British Medical Journal (http://www.bmj.com/content/351/bmj.h4320) has re-examined the 2001 research study sponsored by Glaxo-Smith-Kline that led to the use of Paxil and imipramine in adolescents with depression. They revealed another problem with psychotropic drug trials that often goes unappreciated.
The researchers found that significant data had been omitted from the study, and also that important variables were changed in the course of the study and went unreported. Their analysis of the full data set suggested no evidence of efficacy and significant concerns about harmful side effects, particularly suicidal ideation.
Data can be misreported or misrepresented; but it can also be “left on the cutting room floor.” After all, who is going to rush to report mediocre or harmful results of their drug trials to major medical journals? The BMJ authors are working with an initiative called “restoring invisible and abandoned trials,” and have called for stricter peer review processes for drug trials in general.
These reports should cause significant reflection on the current state of psychotropic drug prescription, and a call for more transparency in showing the results of all relevant drug trials. I am not an expert in adolescent psychiatry; but on the dementia side, I will repeat my frequent contention that antipsychotic drugs are bad news, and any suggestion that they may be of benefit in people living with dementia should be seriously questioned (especially since those previously published studies only showed an overall 18% improvement over placebo to begin with).
There is evidence that other approaches to dementia can significantly reduce and even eliminate the use of antipsychotic drugs. It is time to fund more studies of these methods, and to stop privileging shady drug trials—and drug trials in general—as the only legitimate answer to our problems.