Citizens Commission on Human Rights International

By Kelly Patricia O’Meara
July 23, 2013

Given the enormous potential for great harm, one has to wonder how the Food and Drug Administration, FDA, gets away with giving its stamp of approval on a new “brain wave test,” that allegedly will “help confirm an ADHD diagnosis,” when there is no scientific or medical proof that any physical abnormality exists.

In fact, the mandate of the FDA demands the opposite of its latest approval action. According to the FDA website, the federal agency is tasked with protecting “the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use and medical devices.”

What part of approving a “brain waive test” for a psychiatric diagnosis that doesn’t exist is “assuring the safety and effectiveness?” More to the point, since there is no proof that the alleged psychiatric diagnosis exists, how can the FDA possibly claim that any test, least of all one that consists of interpreting squiggly lines on a piece of paper, is safe or effective? Is this a case of group-think? The FDA heard, has been told, believes ADHD exists?

This kind of thinking is so two months ago. Remember it was just before the American Psychiatric Association (APA), held its annual get-together in May that the National Institute of Mental Health, NIMH, slammed the door on the APA’s Diagnostic and Statistical Manual of Mental Disorders (DSM) which includes “ADHD,” stating the manual is “at best, a dictionary, creating a set of labels and defining each.”

The NIMH further explained that the APA’s diagnoses “are based on a consensus about clusters of clinical symptoms, not any objective laboratory measure…” and “the weakness is its lack of validity.”

And the APA, itself, writes, “There are no laboratory tests, neurological assessments, or attentional assessments that have been established as diagnostic in the clinical assessment of Attention-Deficit/Hyperactivity Disorder.” Okay, seems pretty clear. The ADHD diagnosis is completely subjective and not based in science.

The FDA ignored these facts and, in what appears to be an irresponsible attempt to validate ADHD as a science-based psychiatric diagnosis, has opened the floodgates for creating more victims and the already epidemic numbers of children being diagnosed with the alleged ADHD will skyrocket.

According to the Centers for Disease Control and Prevention, CDC, there has been a 41 percent increase in the diagnosis of ADHD over the past decade and one in five high school boys (11 percent of all school-age children) have received the non-scientific diagnosis.

More troubling is that based on a 100 percent subjective ADHD diagnosis, nearly 3 million American children are currently taking prescription mind-altering drugs as “treatment” that are the equivalent of cocaine, carrying serious adverse reactions.

And aside from the fact that there is zero proof that ADHD is an abnormality of the brain, the FDA’s approval of the new EEG device called, “Neuropsychiatric EEG-Based Assessment Aid,” the NEBA System, is suspect on a number of levels, including its blatant lack of information about the data used to decide on approval.

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