ADHD diagnostic tool

[KOKOagainandagain]

I have just received the following from my local support group:

One of the historic money spinners for the US pharmaceutical industry faces a potential new hurdle.

Parents looking to calm their rambunctious children with drugs such as Adderall and Ritalin might have a tougher time getting prescriptions thanks to a newly approved device that lets doctors peer into the brains of adolescents.

The US Food and Drug Administration approved the marketing of a new device on Monday that measures electrical impulses given off by the brain's neurons to determine if a child between the ages of six and 17 has attention-deficit/hyperactivity disorder, or ADHD.

ADHD is one of the most widely diagnosed behavioral disorders in the US and health advocates complain that doctors often diagnose it for behaviour that could be attributed to other problems. The American Psychiatric Association estimates that 9 per cent of US adolescents has ADHD.

The new device is called the Neuropsychiatric EEG-Based Assessment Aid (NEBA) System and is a non-invasive test that record brain wave frequencies to determine if a child has ADHD.

Shares of Shire and Novartis, which manufacture Adderall and Ritalin, respectively, reacted calmly to the announcement.

That's actually hyperbole. There are differences in the brain activity of people with ADHD, but EEG alone can't 100% discriminate between those with ADHD and those without, so is only useful as an adjunct to diagnosis.

This is an old-ish but useful review. AFAIK, the situaiton hasn't changed al that much since this was written www.adhd.com.au/downloads/Loo2005ADHD.pdf

I find it rather interesting that NEBA has received approval by the FDA, despite there being no trial results published. How does that happen?
clinicaltrials.gov/ct2/show/NCT00595751

Of course, the NEBA system isn't a potential money spinner for its manufacturer at all. Oh no.

Please forgive my cynicism, but this does seem a little fishy.

Charming. People will equate it with a lie detector test and if a child doesn't fit the profile, all support will end up being withdrawn and the parent will be labelled a liar.

Are they perchance trialing it in Salem, Massachusetts? Seems as good a place as any for a witch hunt.

Not that I'm cynical at all, oh no.

Looks like the manufacturer, who sponsored the study, no results of which have been published, has been a bit naughty, in the past
www.fda.gov/ICECI/EnforcementActions/WarningLetters/2003/ucm147274.htm

and this is interesting www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=551872

This company is the manufacturer of the neurofeedback software.

But what if it does help with diagnosis? Also, what's the scoop with neurofeedback?

That's all it does do - help with diagnosis in some cases. It also throws up a lot of false positives, unless used with traditional diagnostic methods, which don't involve buying some expensive equipment. The manufacturers have been marketing it as more than that, without any evidence to back it up.

Neurofeedback shows some promise with ADHD, but no thorough testing has been done to demonstrate that it actually makes a long term difference in adults or children. The studies that have been done all have flawed methodology that don't isolate NFT with respect to other factors which affect concentration, behaviour, etc. There is just as much marketing involved with this as there is with ritalin, adderal etc.

This is a good discussion of the problems with currently available research
help4adhd.org/documents/WWK6A.pdf