Should neuro-products be regulated like pharmaceuticals?

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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.

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3 responses to “Should neuro-products be regulated like pharmaceuticals?

  1. An important discussion to be had, the only extra concern I would add is the potential negative effects of regulation on amount of R&D being done. Without regulation there is the danger of hazardous products, but with heavy regulation it becomes more difficult for start-ups to risk on research. Of course, this is a non-point if people are mostly (mis-)marketing existing technology (like the EEG hype).

    In terms of the more behavioral technologies, there is a nice discussion on if Lumosity’s indexes are useful or not over at the Cognitive Sciences StackExchange.

    • Thanks Artem. You’re right that the regulatory burden (if such companies were regulated like drug companies) would be very heavy. And the effect on R&D and innovation is an old argument that the drug companies have been trotting out for years in an attempt to resist greater oversight. Most serious commentators recognise that legal oversight is required and beneficial in the case of the drug companies though, so I don’t see why it also wouldn’t apply here.

      Thanks for the link about Lumosity – interesting stuff.

  2. Pingback: How to develop and market your neuro-product | NeuroBollocks

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