On the FDA, ADHD, NEBA and other acronyms

Image from: http://www.nhs.uk/Conditions/eeg/Pages/Introduction.aspx

For those of you who haven’t heard, brain scans are coming to the rescue again.

This time to “help diagnose Attention Deficit Hyperactivity Disorder in children”.

WHAT.

WHAT?!

It came out yesterday that the FDA approved the use of a electroencephalogram (EEG) technology called Neuropsychiatric EEG-Based Assessment Aid System (NEBA System) in addition to other diagnostic tools to diagnose children ages 6-17 with Attention Deficit Hyperactivity Disorder (ADHD). For those of you who are unfamiliar, an EEG measures the electrical patterns of activity in the brain, and ADHD is a prevalent disorder in childhood in which children may express hyperactive behaviors and have trouble paying attention. There are many news outlets reporting on this story, and I found these two most helpful in unpacking what’s really going on: The Augusta Chronicle and the Seattle Times.

So here’s the thing. Some research (Barry 1999; Clarke, Barry, McCarthy & Selikowitz, 2001; Gonzalez-Castro, Rodriguez, Lopez, Cueli & Alvarez, 2013 – none of which were actually cited in any news sources I’ll point out) has found that children with ADHD tend to (I’ll emphasize TEND to) have a higher ratio of beta/theta waves than children who do not have ADHD.

What does that mean?

It means that there is a correlation, or relationship, between ADHD symptomology (hyperactive and impulsive behaviors in particular) and the ratio of the brain’s beta waves and theta waves. So basically, people with ADHD tend to show different patterns of brain waves than people without ADHD in this measure. Given what we know about brain and behavior, this is not shocking.

So what’s the problem?

The problem is that despite what modern medicine might like you to believe, brain scanning is not an exact science. It produces raw data that must then, like all other data, be interpreted. Now, I don’t doubt the findings of the authors who suggest that there are EEG differences in children with ADHD, and I’m not suggesting that the information we learn from research shouldn’t be used to help children and families. Far from it.

The problem is that over the last couple of decades, ADHD has been one of the most well-researched disorders in the neuroimaging literature. And though a clearer picture is emerging, it’s hardly clear enough to base a diagnosis on. Study after study has found “differences in the brain” of kids with ADHD, but those differences are not always consistent. There's often a great deal of discrepancy between studies, and scientists are still trying to sort it all out. 

Now, the FDA did find that with the use of the NEBA System the clinical diagnosis of ADHD was more accurate than some standard measures used to diagnosis ADHD (press report here). It was also clarified by the creators of this system and by the FDA that diagnosis of ADHD is a complex process, and that the NEBA System just adds another piece of information to be used in diagnosis.

But that’s not how the real world works.

I’m betting many of you have heard stories, or even experienced for yourself, the “rigorous” diagnostic process that is often encountered when diagnosing ADHD. Sometimes it’s as simple as showing up to your family doctor and saying “I think Johnny’s got ADHD”, and suddenly you’re walking out the door with pills in your hand. 

I say this not to discount all of the hard work that many trained clinical psychologists and psychiatrists do to diagnose ADHD appropriately through actual standards from the DSM, or other diagnostic procedures and interviews with the people who know these children. There are so many clinicians out there doing it right. Gathering a wealth of information is a huge part of the process, and if the NEBA System can help with that information gathering, then fine.

But what about all those clinicians who aren’t out there doing it right? Who don’t take the time to do multiple diagnostic assessments because of time or cost constraints? What happens when the NEBA System starts being used irresponsibly as the only measure of ADHD? What happens when you walk into your doctor’s office and say “I think Johnny’s got ADHD” and your doctor says “Oh we’ve got a brain scan for that that will tell us right away if he has ADHD." What happens then?

Well, the FDA has just opened the door for us to find out.

The thing is, stuff like this has been around for decades. (Don’t even get me started on the abuse of neuroimaging procedures—not to mention people—by places like the Amen Clinic...) And hey, maybe it helps sometimes to have multiple types of information, not just for diagnosis, but for acceptance that a diagnosis might really be necessary in the first place.

But this use of neuroimaging techniques to diagnose disorders was always considered on the fringe. Given that the FDA is pretty much considered the gold standard when it comes to medical procedures and practices, the fact that they’ve signed off on this is opening the door for more of this type of irresponsible use of a complex technology with the sole purpose of exploiting people and systems to make money.

There. I said it.

I’ll end my diatribe with this. I respect that there is scientific evidence to back this up, and in doing some background research on the subject, it looks pretty sound. And of course we should be using knowledge to help people.

But we are NO WHERE NEAR understanding all the ins and outs of the brain, let alone what our fancy technology is actually telling us.

So yes, if you want to use this as a tool to help supplement other diagnostic tools that have stood the test of time, then fine. Use it. But I fear the FDA signing off on this is just setting precedent for all kinds of improper uses of technology to follow.

Brain scans are not the panacea. Don’t treat them as such. It sells the technology, and the people who have devoted their lives to studying the human brain, short.