Today, Furious Seasons brings us the silence of the U.S. Food and Drug Administration’s (FDA) Thomas Laughren, director of the FDA’s psychiatry products division, on the issue of pediatric bipolar disorder diagnosis. By approving medication for pediatric bipolar disorder, the FDA has, by government decree, sanctioned a brand new diagnostic category out of the blue.

The FDA also suggests that there is widespread agreement about pediatric bipolar disorder and little controversy about the wholesale prescription of the same kinds of medications prescribed for adults (despite there being absolutely zero long-term studies done on pediatric populations to see whether there are developmental effects of these medications on a child’s growing brain and body):

Steven Hyman, a Harvard psychiatrist and former NIMH head, has publicly expressed his concerns about the meds these kids are given: “We don’t know the first thing about safety and efficacy of these drugs even by themselves in these young ages, let alone when they are mixed together.”

In 2006, Thomas Insel, NIMH director, also pointed to the meds being given bipolar kiddos as being a concern, telling the New York Times, “There are not any good scientific data to support the widespread use of these medicines in children, particularly in young children where the scientific data are even more scarce.”

In an op-ed, Larry Diller of UCSF noted: “Biederman shocked the child psychiatric world in 1996 by announcing that nearly a quarter of the children he was treating for attention deficit hyperactivity disorder also met his criteria for bipolar disorder. Up until then bipolar disorder was rarely diagnosed in teenagers and unheard of in prepubertal children. Biederman could justify his findings by simply broadening the semantic definitions of a previously more circumscribed condition contained within American psychiatry’s bible — the ‘Diagnostic and Statistical Manual of Mental Disorders’.”

Now, granted, this wouldn’t be the first time the FDA has done this — approving medications for populations where the diagnosis isn’t officially recognized by the only diagnostic manual used (the Diagnostic and Statistical Manual of Mental Disorders, otherwise known as the DSM).

Worse yet, the FDA isn’t authorized to approve medications for diseases or disorders not yet officially recognized. It is overstepping its regulatory authority by doing so and has done so for years because who’s going to call them on it? Well, perhaps Senator Grassley would be interested in pursuing this question further…

Read the full entry: FDA Psychiatry Chief Refuses To Address Questions About Pediatric Bipolar Disorder

Dr. John Grohol is the CEO and founder of Psych Central. He is an author, researcher and expert in mental health online, and has been writing about online behavior, mental health and psychology issues -- as well as the intersection of technology and human behavior -- since 1992. Dr. Grohol sits on the editorial board of the journal Cyberpsychology, Behavior and Social Networking and is a founding board member and treasurer of the Society for Participatory Medicine.

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Please contact the FDA and help our children « Beyond Meds (9/11/2008)

    Last reviewed: By John M. Grohol, Psy.D. on 14 Aug 2008
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