Tag Archives: ADHD

Should neuro-products be regulated like pharmaceuticals?

brain-pharma-happy-pills

This is not a joke. This is an actual product, on sale now at Amazon.com

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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Interactive metronome treatment for ADHD/ADD; swing your arms about, cure your brain

Ian Dury. Because… any excuse.

One of the best things about starting this blog was several e-mails I got from like-minded people saying nice things, and often, pointing me towards interesting bits of neurobollocks that I wasn’t aware of. Such was a series of e-mails from Deborah Budding and Michael Thaut (who must be one of only a few people in the world who holds posts as Professor of Music, and Professor of Neuroscience – cool) about the ‘interactive metronome’ technique. Michael’s research (unsurprisingly) focuses on the interplay between the brain and music, and in particular, the processing of temporal information as it relates to rhythmicity, so it’s probably fair to say he certainly knows his way around a metronome.

But what’s this interactive metronome business? Well, as you can see in this video on the hypochondriac’s website of choice (WebMD), it’s basically waving your arms about and moving your feet in time to a regular beat. So, it’s basically dancing then, but much more boring.

Surprisingly, given it appears to be such a simple technique, some people are claiming that it can have profound effects, and assist with various disorders such as ADHD, Parkinson’s, MS and even post-brain injury and stroke. The usual bunch of jokers with slickly-designed websites have sprung up offering treatment for all these things and more. The ‘How it works’ section of that website claims that the underlying deficit in a variety of disorders, claiming that the underlying dysfunction in ADHD, autism, dyslexia, Parkinson’s and others is just a ‘neural timing deficit’. The exercises used in IM correct the timing deficit, and therefore (supposedly) treat the disorder.

To say this is startlingly simplistic would be a massive understatement; it’s just plain wrong. The precise neurological issues in many of these disorders are difficult to pin down and are the subject of active investigation but, to take a simple example, we know exactly what the problem is in Parkinson’s; neuronal depletion in the substantia nigra. To claim that it’s some vague neural ‘timing’ issue goes well beyond disingenuousness and into the realm of outright deception.

There’s even a home-based version of IM therapy, that can be run on any computer – however the basic equipment (wiresless button boxes, tap mats for the feet etc.) and the software licence cost $800.

A PubMed search for ‘interactive metronome adhd’ actually produces five hits! However, on closer inspection, all five articles are seriously compromised in some way – studies with no control group, or with very low numbers. Interestingly, one of the papers that pops up is one I’ve discussed before in reference to Brain Balance Centers. So, IM appears to form a cornerstone of what the Brain Balance guys (chiropractic, with a thin layer of neuro-woo laid on top) are pushing too. The IM guys have gone to a lot of trouble to make their approach appear scientific – there’s a well-populated ‘Science’ section on the website, that contains links to lots of articles, however, many of them are ‘white papers’ of uncertain provenance, and the rest are articles from obscure journals, or on barely relevant topics.

Another problem with IM is that it gets conflated with serious interventions. There’s a large field of study focussed on the use and effectiveness of musical-type interventions for a variety of neurological disorders (broadly, called Neurologic Music Therapy, or NMT) that has some solid research behind it. The slick marketing of IM seeks to conflate their approach with much more high-standard music-based therapy approaches.

In Prof. Thaut’s words (my emphases added):

First, where is the research? Studies that back up the clinical effect of IM directly, are very rare or nonexistent. A small study from 2001 is one that comes up repeatedly. One small study does not build clinical evidence. IM seems in general a well marketed but unresearched application. From a research point I see no evidence for the therapeutic benefit of IM.

Second, brain mechanisms in therapy work differently. Possibly to fill the research void IM generously includes ‘borrowed’ research that has nothing to do with their device. Since I am one of the authors they use I have to clearly  state that my brain research in music and rhythm does not address IM and our results do not support IM applications, neither with patients nor physiologically in explanatory brain mechanisms. The only forms of therapy in brain rehabilitation that work are active and specific exercises based on functional learning and training paradigms, not machine tapping. 

Last, rhythm has its own life. The claim that tapping to a metronome improves timing in patients which in turn transfers to all kinds of cognitive and motor improvements is not only unsupported by research but seems based on a misunderstanding. Rhythmic synchronization is a very complex process that fluctuates continuously on a millisecond level and is inherently unstable and variable. This time flexibility is the actual hallmark of functional entrainment. Therefore the IM definitions and measurements of what constitutes rhythmic improvement seem physiologically and functionally meaningless.

So, there you have it. If you’re concerned about your child’s sense of rhythm (for some reason?) you’d probably be much better off signing them up for dance classes, or piano lessons. It’ll almost certainly be cheaper, and they’ll likely have a lot more fun too.

Utterly shameless diagnostic brain imaging neurobollocks

The impish Dr Amen, with (presumably) some fans. Wonder if he's planning on scanning their brains?

The impish Dr Amen, with (presumably) some fans.

Christian Jarrett’s article in Psychology Today (“Your 5-Step Self-Defence Program Against Neuro-Nonsense”) that I linked to in my previous post briefly mentioned diagnostic SPECT (Single-Photon Emission Computed Tomography) imaging, and the paper he cites (Chandler and Chatterjee, 2011 – open access – yay!) goes into some more detail about this particular brand of neurobollocks. After looking into it myself a little bit, I was absolutely stunned that some doctors a) had the gall to to continue offering these diagnostic methods and treatments to people, and b) that they were allowed to continue doing so by medical regulators (I guess that’s the USA’s free-market, laissez-faire approach to medical care – gotta love it!).

So, a little background. A common theme in neuroimaging research is attempting to identify differences in the brains between different groups of people. Male/female, musicians/non-musicians, schizophrenics/non-schizophrenics, whatever. This is all very interesting and worthwhile – if we can identify a common brain pattern or structure that is different in say, schizophrenia then we may be able to devise better treatments that target it. Voxel-based morphometry is one common method of looking at differences and assesses the relative size/shape of different brain structures, but there are lots of other methods that either look at anatomical or functional differences. The important point here is that you always need a group of people of each type that you want to compare. People’s brains vary pretty widely in the size and shape of the sulci and gyri, and in the amount/location of functional activity that you see in a given task. What is being sought in these studies is a reliable difference that is consistent across the group, and remains as a statistical effect, once all the (random) individual variation has been taken into account. Many people’s brains are a bit funny-looking, but 99 times out of 100 it’s just normal individual variation.

What this means is that developing imaging-based biomarkers that reliably indicate particular states or conditions in an individual is fraught with difficulty. Some progress is apparently being made in this endeavour, but a lot of people are still very sceptical about the idea, and rightly so.

However, Dr Amen, (of the eponymous ‘Amen Clinics‘) is certainly not one of those people. He’s been using diagnostic SPECT imaging for years, and has clinics in six major US cities. Dr Amen uses SPECT imaging to diagnose ADHD, anxiety, depression, addiction, autism, ‘marital conflict'(?!), and for generally healthy people who want to lose weight, or just ‘optimise’ their brain. How does taking a SPECT image of their brain help with this? It’s not really clear, but unsurprisingly, Dr Amen has a slick-looking brain-training-like program (‘The Amen Solution’) that promises all the usual bollocks, and an online store filled with his (many!) books, DVDs, etc. plus (of course) his own brand of dietary supplements. So, basically, I’m guessing that the results of the SPECT scans in his clinics typically indicate that the patient needs to complete a course of his brain-training, or supplements, or both.

Just to be clear – there’s absolutely no way that a SPECT scan of an individual can show up anything useful in diagnosing these disorders. Dr Amen is charging people thousands of dollars, and injecting them with radioactive substances, for absolutely no sound medical reason. 

Why use SPECT? The spatial resolution of the images is crap, and no-one uses it for clinical or research work that much anymore. However, it’s the cheapest of the 3D imaging techniques that can show functional activation. MRI scanners are expensive to buy and maintain, and need fairly large facilities. PET scanners use short-lived radio-isotopes, meaning you have to synthesise them yourself and use them immediately – you need a team of chemists and a well-kitted out laboratory. SPECT uses off-the-shelf isotopes with long half-lives; much, much cheaper and easier.

Dr Amen is a funny one, to be honest. Unlike the Brain Balance Center charlatans , he at least has some medical training and certification, and he publishes some research papers, occasionally even in peer-reviewed journals. He may perhaps be a true believer in what he’s doing, which makes him less mendacious but unfortunately also more stupid. Of course, where one quack leads others will follow, and copycat clinics have sprung up, also using SPECT, and claiming similar things; Dr SPECT scan, and CereScan are two of them. Dr Amen’s slick, media-savvy approach (he seems to be a regular on those dreadful audience-whooping, self-help TV shows they have in the US) marks him out as a serious operator though. Because he has some appropriate training, and has published some research, the Amen Clinics only gets a 9 out of 10 on the Neurobollocks rating scale; I know, I know, I’m just too generous sometimes, it’s a problem.

You can read more about the radiant Dr Amen and his techniques here, and there’s also an interesting Q & A with him over on QuackWatch.

Brain Balance Centers: total and utter neurobollocks

Masthead from the Brain Balance Center's website. "clinically proven"!

Masthead from the Brain Balance Center’s website. “Clinically proven”, and oooh… “holistic”. Marvellous.

Brain Balance Centers are a network (actually, to be precise, a network of franchises) of treatment centers spread across the United States, currently operating in 54 locations; most of the major US cities. They offer a treatment called the ‘Brain Balance Program’ that claims to be able to improve:

1. Academic performance
2. Social abilities
3. Cognitive function
4. Sensory and motor skills
5. Visual-spatial organizational skills
6. Immunity and nutritional health

They also claim to effectively treat pretty much any developmental disorder under the sun, including autism, ADHD, Asperger’s, Tourette’s and dyslexia, without the use of any drugs. This is because all these disorders are (apparently) caused by an “underlying functional imbalance or under-connectivity of electrical (brain) activity within and between the right and left sides of the brain.”

Any alarm bells ringing yet? They should be. Whenever someone comes along with a miracle-cure for a range of unrelated conditions, and has come up with the equivalent of a Unified Field Theory of neurodevelopmental disorders, something must be a bit fishy. So it appears in this case. There have already been a couple of excellent take-downs of the claims that Brain Balance Centers make. The first is by the really-very-wonderful Emily Willingham, and you can find it here. Emily expertly refutes a number of the key claims, and proceeds to drill down on the list of evidence and references provided on the website. Her conclusion is that the claims are an “enormous steaming pile of bullshit”.

Another great piece on these guys is by Harriet Hall of SkepDoc, and can be found here. This examines in detail a study published in the International Journal of Adolescent Medicine and Health (which at least appears to be a ‘proper’, if obscure, journal). Harriet notes that despite all the waffle about functional disconnection and hemispheric imbalance of the brain, the exercises performed by the kids in the study were relatively simple (such as synchronising movements to a metronome) and the conceptual link between the treatments and correction of the underlying ‘hemispheric disconnection’ is vanishingly tenuous. Most damningly, the study didn’t include a control group, meaning it’s possible (likely?) that any improvement seen was simply a placebo effect (or more precisely, a Hawthorne effect).

The last author on that paper is a guy named FR Carrick, and all the authors’ affiliations are listed as the “The FR Carrick Institute for Clinical Ergonomics, Rehabilitation and Applied Neuroscience”; and this is where it gets really interesting. Dr Carrick is a specialist in ‘Chiropractic Neurology’. Chiropractic is a branch of alternative medicine with a fairly wacky history (founded in 1895 by a magnetic healer named DD Palmer), and essentially aims to treat health issues by manipulation of the spine. Debunking chiropractic is well beyond the scope of this piece, but let’s just note that there is a paucity of evidence for effectiveness in any condition other than low-back pain, and even there, evidence is pretty mixed. ‘Chiropractic neurology’ as a discipline then, is highly suspect.

It turns out the FR Carrick Institute of whatever whatever has a very glossy and slick webpage, that on closer inspection, really doesn’t contain a whole lot of content. The Wikipedia page for the institute gushes on at some length about the incredible research happening at the Institute, and the “faculty of world class scientists and clinical researchers” employed there (clearly in need of some de-biasing, Wikipedia) but the only personnel mentioned on the website are in the ‘Management’ section: Dr Gerry Leisman and Dr Robert Melillo. Gerry Leisman seems to have had a somewhat chequered career at several universities in the US and UK. Interestingly, in 1994 he was sanctioned by the NIH office of research integrity for falsely claiming to have a MD degree from the University of Manchester (amongst other things).

Dr Robert Melillo (and congratulations for making it, if you wondered where I was going with this digression…) as well as being the executive director of the FR Carrick Institute for advanced alternative navel-gazing is also the founder of… you guessed it! The Brain Balance Centers! Let’s look at his list of eminent-sounding qualifications listed on the site shall, we?

“…adjunct professor of functional neuroanatomy for the graduate doctoral neuropsychology program at Touro College, NY and Leeds Metropolitan University, England.”

Well, they sound like academic appointments at genuine, if hardly wildly-prestigious institutions. Unfortunately,  a search of the Leeds Metropolitan University website produces no hits for “melillo”. A search of the Touro college site also comes up blank (except for a Nicholas P. Melillo – oooh, so close!).

“He is also an associate professor of clinical neurology and childhood behavioral disorders at The Carrick Institute, in FL.”

This Carrick Institute in Florida (not to be confused with the one mentioned above, in New York state!) appears to be a teaching school concerned with chiropractic neurology, and has a loooong list of associate/assistant professors.

“He holds a master’s degree in Neuroscience and is currently completing his PhD in Clinical Rehabilitation Neuropsychology.”

No indication of where he obtained his Masters degree, or where he’s working on his PhD. I’m betting that it might be in one of the FR Carrick Institutes… Incidentally, if he doesn’t have a PhD, or any medical qualifications, why is he calling himself ‘Dr’?

“He is board certified in Chiropractic Neurology and is the former chairman of the American Board of Chiropractic Neurology.”

Meh.

“He is also President of the Foundation for Cognitive Neuroscience.”

The what, now? I can’t find anything online about a Foundation for Cognitive Neuroscience, in fact a google search for “Foundation for cognitive neuroscience” +melillo returns precisely zero results.

My point in all this is not to expose this guy as some kind of fraud, fun though that might be. I find it interesting that Dr (?) Melillo’s background is obviously in chiropractic treatment, and he’s found a gosh-darn-whizzo way of spinning this out into a national network of treatment centers for children. Interestingly, chiropractic isn’t mentioned anywhere on the Brain Balance Center site at all, and it’s not clear if the treatments are derived from chiropractic theory/practice. This paper from 2008 notes that chiropractic has something of an image problem, and is declining in popularity – re-packaging it as ‘hemispheric integration therapy’ for developmental disorders is a good wheeze – it allows a complete break with the previous practices, and allows you to pander to the fears of time-poor, cash-rich parents (a course of treatment is reported to cost around $6000).

So, will your child benefit from treatment at a Brain Balance Center? Possibly they will; regular sessions of individual attention and structured exercises of almost any kind are probably good for children. Will they benefit more than if you just took them to the park to ride their bike every weekend? Most likely not.  The neuro-inspired claims that the Brain Balance Center makes are an incoherent muddle of utterly fly-blown bullshit, built on the foundation of an alternative therapy (chiropractic) which itself is highly suspect. Don’t waste your hard-earned money people – it’s an out-and-out scam.

What this means, is that the Brain Balance Centers receive the highest honour it’s possible for this humble blog to bestow – a mighty 10 out of 10 on the NeuroBollocks rating scale!

Finally, just to leave you in a good mood, here’s Eddie Izzard with a brief bit on chiropractors:

**Update**

I’ve just been sent a link to another piece I wasn’t aware of by Jon Brock. Jon is a developmental disorders researcher in Australia, and became aware of a video discussing one of his papers by a chiropractor called David Sullivan, who it turns out, is connected to the various Carrick institutes, and Robert Melillo, and runs Keystone Chiropractic Neurology. The article is well worth a read, and there’s a lot of good discussion in the comments section too.