What’s a "black box"? It can be a machine, or a piece of computer code, some body function, anything that does something – turns an input of some kind into an output of some other kind. The term is used when we either don’t know or don’t care how it does it. For most, the computer your reading this on is a black box that you type things into or manipulate visual images on and do all kinds of marvelous things, but know little of the internal workings of the machine. So long as everything functions like it’s supposed to, we rarely think of the myriad of black boxes that are layered inside that big black box to make it work. Generally, we live surrounded [and inhabited by] countless black boxes – operating outside awareness with opaque internal workings that we ignore.
Our attention is drawn to a black box when it doesn’t work: the magic carpet that takes us to work becomes a car when it sputters [out of gas?], the lights don’t come on in a dark room [burned out bulb?], we wake up with uncomfortable symptoms [off to the doctor]. We use what we know about the black box to fix it or seek help from an expert who can. And what we do then, or the mechanic does, is look inside at the actual system – tinker around, maybe replace one of the smaller black boxes inside. And when we’re stumped, sometimes we replace it [if we can]. We like to think that the path to the solution is a straight line, but that’s only true for the experienced experts. The rest of us muddle around in the set of things we know about, trying one thing after another. In a set theory approach, we don’t know how the black box works, but we know the elements in the sysytem. So maybe we look out the window and there are no lights in the hood, so we call the power company. If that’s not true, we start tinkering with system light-up-the-dark-room according to our skill.
We all know there’s something bad wrong with the system that delivers the medications we’re given for the afflictions of life. Some don’t deliver as advertised. Some cost a mint and don’t deliver as advertised. And some are way more toxic than we were told. The system is in a state of dysfunction and there’s a general agita in the air. So people have started deconstructing the set [system] looking for what’s wrong, and there’s been plenty to find: corrupted KOLs, sleazy marketers, jury-rigged continuing medical education, ghost writers, guest authors – the list goes on and on and dips into regions Peter Gøtzsche legitimately calls organized crime. There’s so much, in fact, that many throw up their hands in abject disillusionment and dispair.
Well the real experts looked at all those things wrong and organized them for us, and what they found out was that they were all dependent on one thing – the reporting of clinical trial data. The randomized blinded clinical trials get done, are un·blinded in secret, and get published in articles that support all the other things that I listed earlier and more. So when consumers started suing and lawyers started subpoenaing, they got a glimpse into a black box hitherto inaccessible. The more various people have looked, the clearer it has become that the black box between the raw information from the trials and the public rendition is ground zero – action central for what’s wrong with this system. The medical articles don’t speak the truth of the data, and it happens a lot – a whole lot.
In all the corruption and misbehavior, this nodal point has emerged as the crucial mechanism in the works – secrecy in the results of clinical trials created a black box that has become a black hole in a vital system. We’ve thrown as many regulations as we can at the other dysfunctional parts, but so long as this piece remains opaque and off limits, everything else is superfluous. It’s supported by arguments of patient confidentiality and more recently competitive advantage, but we suspect the real motive is simple corporate greed. In psychiatry, some of the blockbusters wouldn’t have even been approved for use, much less turned into commercial phenomes, absent this opaque black box. This industry arose from the one that made inert patent medicines, gradually turning into one with a place of legitimacy. But the loophole of a black box at a critical point in the process allowed them to fall off the wagon. So whether you go for Goldacre’s "sunlight is the best disinfectant," or the RIAT team’s frogmen, or my black box quaisi·systems theory, all roads have lead us to the only viable solution – data transparency, by law, in 2014: