Monday, July 22, 2013

A Brain Wave Diagnostic Test for ADHD?

Last week there was a lot of media buzz about a new product that uses brain waves to help diagnose ADHD. While the FDA press release was very carefully worded, the media was not always so careful. Below is a guest blog by Martijn Arns, PhD, a biological psychologist and researcher affiliated with Utrecht University in the Netherlands, to give all our CHADD members more information about this assessment device. This statement has been approved and adopted by CHADD’s Professional Advisory Board, the group of leading researchers and clinicians who help CHADD stay grounded in the science. - Ruth Hughes, PhD

A comment on: FDA permits marketing of first brain wave test to help assess children and teens for ADHD

guest blog by Martijn Arns, PhD
Utrecht University, Department of Experimental Psychology, Utrecht, The Netherlands
Research Institute Brainclinics, Nijmegen, The Netherlands

 In July 2013, the US Food and Drug Administration issued a press release with the above title, which quickly became very popular and attracted worldwide coverage with sources referring to it as a first brain test to diagnose children with ADHD. The test is commercialized by NEBA. The brain wave test referred to by the FDA consists of an EEG test (a technique which measures the electrical activity of the brain) whereby specifically the theta and beta waves are quantified and expressed in a so-called Theta/Beta ratio. Indeed, this measure has often been reported in scientific literature to deviate in children with ADHD. However, a recent meta-analysis which included all literature published on this measure to date – including a study from authors affiliated with NEBA – concluded that Theta/Beta ratio is not a reliable diagnostic marker for ADHD.* In a minority of ADHD patients (~25-30%), this measure is consistently found to deviate; however, such a percentage is too low to be used as a standalone diagnostic test. 

According to the FDA release, this brain wave test is also not approved as a standalone diagnostic test, but rather: “When used as part of a complete medical and psychological examination, the device can help confirm an ADHD diagnosis or a clinician’s decision that further diagnostic testing should focus on ADHD or other medical or behavioral conditions….” Therefore, this new device can simply be seen as one test in the whole spectrum of tests already used by clinicians to come to a diagnosis, similar to neuropsychological tests, IQ tests, ADHD rating scales, etc. This EEG test is not intended as a standalone diagnostic test.

Finally, also note that the FDA does not decide or rule on which treatments and tests are evidence-based or not. As stated in the title of their news release above, the FDA “permits marketing” of the device, and this decision is based on data submitted by the manufacturer that the device is safe to use. Scientific research and professional associations such as the American Psychological Association have guidelines to evaluate which tests and treatments can be considered evidence-based, and the EEG Theta/Beta measure is not recommended for making a diagnosis of ADHD.

*Arns, M., Conners, C. K., & Kraemer, H. C. (2012). A decade of EEG theta/beta ratio research in ADHD: A meta-analysis. Journal of Attention Disorders. doi:10.1177/1087054712460087

Monday, July 1, 2013

Drug Shortage Appears to be Growing

by Ruth Hughes, PhD

In just the few short weeks since my last blog, we have seen the shifting demand for methylphenidate generic products (Ritalin) grow from a shortage in two companies to six companies today. Pharmacists are finding it harder to order and it is taking longer to fill orders. The number of complaints coming to CHADD and to the American Academy of Child and Adolescent Psychiatry is also growing.

But most telling are the early responses to our survey asking patients, parents, and physicians to tell us if they are experiencing shortage problems in their area. Forty-four percent of the respondents are experiencing problems getting prescriptions filled for generic versions of Ritalin or other stimulant medications.

But we still need your help to define the scope of the shortage. We need to increase the overall number of respondents before taking this information to the federal government. Please fill out this short survey immediately and tell us about your experience. If you are a parent, please answer the patient questions. We need to hear from you even if you are having no problems, so we can gauge how serious any growing shortage might be. The survey will only take a few minutes to fill out and can help us ensure that there is an adequate supply of stimulant medication available.

CHADD and AACAP are poised to take action. Due to our concerns on this issue in 2012, the FDASIA law now contains a mechanism for addressing shortages that of medications that come under the purview of the Drug Enforcement Agency. The Secretary of Health and Human Services (FDA’s mother agency) can request the Attorney General of the Justice Department (DEA’s mother agency) to consider what actions the DEA should take to address the shortage and respond in 30 days. We already have a meeting scheduled with the FDA and will be asking for a meeting with Secretary Sebelius once we have a large enough response rate to the survey.

In the meantime, what can you do? You may have to call several pharmacies to find one in your area that has medication available. Report your shortage to the Food and Drug Administration by emailing with the specific name of the medication, the dosage and where you are located. And most importantly, please click HERE to complete this short survey by July 8. We will keep you updated on the scope of the shortage and our actions to address it.

Ruth Hughes, PhD, is CEO of CHADD.