For whatever reasons (fashion, new technology, an endemic dissatisfaction with the status quo) we appear to be entering the age of the mass-market neuro-product. Many neuro-businesses (such as the many varieties of ‘brain training’ products) are aimed at normal, healthy customers, however some of them tip over the line into what could arguably be called medical treatments. For instance Brain Balance Centers claim to treat a wide range of disorders including autism, ADHD and Tourette’s; conditions well-recognised and characterised by modern (clinical) science. These putative medical uses of technology (meaning technology in a broad sense, in that a set of developed therapeutic techniques such as Cognitive Behaviour Therapy might be considered a ‘technology’) are currently completely unregulated.
This legal situation stands in stark contrast to most other medical
treatments and devices which (even in the famously laissez-faire health care industry of the USA) are very rigourously regulated indeed. Pharmaceutical companies have to provide extremely robust evidence of the effectiveness, tolerability, side-effects etc. of their products, and expend a great deal of effort, time, and money collecting clinical trial data in order to do so. This is entirely as it should be; before a pharmaceutical product hits the market the regulators (the FDA in the US, the MHRA in the UK) need to be satisfied that the compound or treatment a) works as the company claims, and b) is relatively safe, when balanced against the potential benefits in the medical conditions it’s designed for. Even the mildest drugs (such as over-the-counter pain medication) have the potential for harm if misused, so this balancing of risks and benefits (backed up by hard evidence) is very important. This burden of regulation on the big pharma companies is pretty onerous, but it’s absolutely necessary in order to protect consumers and patients. Many have argued that the current regime is ineffective and are campaigning for even more oversight and accountability.
Should we not hold neuro-products to the same standard? After all many of these companies claim their products directly affect the brain, just like psychoactive drugs. Whether they actually do or not is of course a matter of debate, and the hard data are generally lacking,
One could argue that the vast majority of, say, brain training products are relatively harmless, and that the worst potential outcome is that someone just wastes a lot of their time. This is probably true, and my purpose here is not to scare-monger about playing computer games (I’ll leave that to Baroness Greenfield). However other products do have a much greater potential for harm. The foc.us transcranial Direct Current Stimulation (tDCS) device (which I’ve written about before here) certainly falls into that category. This product claims to directly stimulate the frontal lobes through the application of electrical currents to the brain. The FAQ section of the foc.us website contains this:
“Is foc.us FDA approved?
No. The focus gamer headset offers no medical benefits, is not a medical device, and is not regulated by the FDA.”
So, what is it then? Is it classed as a toy? Does that mean it doesn’t really do anything? I wonder how long it will be before some bright spark decides to make a quick buck and starts marketing tDCS devices like this for particular medical conditions? (ADHD would be a popular choice.) In that situation it would seem that the position that these aren’t medical devices would be much harder to maintain. Mark my words; some dead-eyed, marketing-droid with a sharp suit and a howling abyss for a soul is probably preparing some material for a product launch like this as I type these words.
The line between medical and non-medical treatments has always been pretty shady, and open to interpretation. Many nutritional supplements are marketed as having medical uses, and some may even actually be effective. It seems to me that the neuro-businesses who are seeking to commercialise brain-altering products are somewhat hoist by their own petard: Either they admit that their products are essentially ineffective (and therefore not in need of regulation), or they maintain their claims about ‘changing the brain’ and submit to a pharma-style regulatory oversight (with all the enormous hassle and expense that involves). At the moment, the technology is running ahead of what lugubrious legal systems can keep up with, but if the regulators do decide to start paying attention, the neuro-companies may be forced to (at the very least) undertake a radical overhaul of their business model. The business that can’t substantiate their claims and show that their product is safe will be forced to withdraw them from sale, and this can only be a good thing for consumers.
Transcranial direct-current stimulation – don’t try it at home
“Many Shubs and Zulls knew what it was to be roasted in the depths of the Sloar that day I can tell you.”
I’ve written before about tDCS and in particular the device produced by a company called foc.us; a company marketing a tDCS device to gamers. As a brief recap, tDCS involves passing a low-level electric current through your brain, and thereby attempting to stimulate particular regions of the cortex in order to enhance particular functions. Academics have been using this (and similar) method for a while now, and showing some interesting effects in all kinds of motor, sensory and cognitive domains (for a fairly broad review see here; PDF).
When academics perform this procedure on their experimental subjects for the purposes of research they have to get clearance from an ethical review board first, and they observe strict limits in order to ensure the safety of their participants, both in terms of the time they stimulate for, and the amount of electrical current they use. However, there is a community of amateur tDCS enthusiasts, who build their own equipment and zap their brains at home. If this sounds like a spectacularly bad idea, you’d be dead right. These guys (and let’s face it, it’s usually guys) naturally aren’t bound by the same safety rules; the only limit is their own stupidity.
TDCS appears to be becoming more mainstream, with commercial products like the foc.us headset and positive write-ups in media outlets (like this one and this one) helping to raise the profile of what has been up until now, a pretty niche activity. This BBC report focuses on the military applications of the technology and proclaims that the US military are ‘very interested in its potential’. Yeah, well… the US military also ran a 20-year research program into remote viewing and other psychic phenomena (only discontinued in 1995!) so let’s not put too much faith in their ability to spot obvious bollocks.
The point I want to get across here is that DIY-tDCS is not only pretty unlikely to actually do anything useful, but can also be potentially extremely dangerous. I know, right? Who’d have thought that passing electric currents through your brain might be a problem? The tDCS sub-reddit page is full of horror-stories ranging from people suffering electrode burns (like this guy) to this story of a user suffering crippling anxiety, panic attacks and depression for more than a year after tDCS. Whether the tDCS actually caused these fairly extreme symptoms in this particular case is somewhat debatable, and probably unknowable, but the point is that relatively severe adverse events can, and do happen with these devices. Most worryingly of all, there’s a report here on the electrical safety of the commercial foc.us device, which suggests that it doesn’t perform in the manner it specifies in terms of regulating the voltage, and can cause skin burns. This user claims to have suffered severe migraine-like pain after a session with the foc.us device.
To sum up:
Do not pass electrical currents through your head! It is a bloody stupid thing to do.
Seriously, if you want to give yourself some kind of an ‘edge’ in gaming, or studying, or whatever, just have a quadruple espresso – much safer and more effective.
Thanks to @neuroconscience for pointing out the tDCS horror-stories on Reddit.
2 Comments
Posted in Brain Training, Commentary, Medical, Products
Tagged brain, Reddit, tDCS, transcranial Direct Current Stimulation