The FDA Drinks the Bipolar Child Kool-Aid`

“Drinking the Kool-Aid” is a metaphor used in the United States that means to become an unquestioning believer in some ideology, or to accept an argument or philosophy wholeheartedly or blindly without critical examination. The phrase can sometimes have a negative connotation, or can be used ironically. The basis of the term is a reference to the November 1978 Jonestown Massacre, where members of the Peoples Temple were said to have committed suicide by drinking a ‘Kool-Aid’-like drink laced with cyanide” (Wikipedia).

In the U.S., official acceptance of the legitimacy of a diagnosis follows one road and the approval of a psychiatric medication as safe and effective follows a separate road.    The roads are not parallel, and they rarely cross.  Child Bipolar Disorder provides a rare exception to this.  The FDA provided unwarranted support for a controversial child psychiatric diagnosis – bipolar disorder in children- by requesting a just-published study of it with lithium.

The FDA has usually taken a very conservative view about medication studies.  For example, they have rarely allowed a drug company to gain approval for a drug that treated only a symptom of a disease rather than the full disease itself.   In psychiatry, up until a very recent exception, they have only given approval to drugs that treated disorders found in the DSM list of psychiatric diagnoses.  The exception was the recent approval of Risperdal for the treatment of aggression in children with autism

Theoretically, the diagnosis of bipolar disorder in children had been approved by APA’s DSM committee as bipolar disorder in adults was approved and most diagnostic criteria in the DSM system are assumed to apply identically to children and adults.   No new designation from the APA was formally required to ratify the diagnosis in children.  Although this may have provided an administrative solution to the problem of bipolar disorder in children, it did not answer the more relevant question of whether bipolar disorder actually did exist in children.  Initially, the FDA seemed to have some misgivings about the situation as reflected in its decision to approve testing for the effectiveness of antimanic agents only down to ages 10.

The FDA’s decision to allow testing of anti-manic agents for children down to ten years of age ignored those who believed that the disorder did not exist in this age range and lent an important endorsement of the diagnosis to those who advocated for the diagnosis in children below the age of 13.  Disappointment in the FDA’s role in pediatric bipolar disorder for those who object to the diagnosis in prepubertal children intensified the past month with the report of an FDA study of bipolar disorder in children down to age seven.

In the June, 2011, issue of the Journal of Child and Adolescent Psychopharmacology, Findling and others report a study of the dosing strategies of lithium in 60 children with as young as seven (average age of about 12).  The article notes that the study was requested by the FDA.  This FDA study indirectly serves to confer legitimacy on this controversial diagnosis.  There is scant evidence that bipolar disorder exists below the age of thirteen, and even less evidence that lithium has any place in the treatment of children that young.  The FDA seems to have lent its considerable authority to the diagnosis of bipolar disorder in children of that age, as well as the possible utility of lithium in treating them.   

The FDA may have been acting on alternative ethical imperatives.  First, the FDA has adopted welcome federal mandates to include testing of children for any medication used in adults.  This is to insure that data are gathered about medications’ effects and dosage requirements in children.  In the past, psychiatric drugs were primarily tested in adults and those who prescribed the drugs for children were left to improvise the dosages of the medication and frequency of administration.  Second, many of the psychotropic medications studied in adults are used in prepubertal children and there might be a legitimate public health need to have the effect of these medications studied more systematically in the younger children for whom they are prescribed.

The article did not express any misgivings or reservations about the existence of bipolar disorder in prepubertal children.  The existence of the disorder was the assumption of the article and was never questioned. 

The FDA should not have lent its imprimatur to a medication study of a disorder that does not exist in children.  

Copyright Stuart L. Kaplan, M.D.




This entry was posted in Uncategorized. Bookmark the permalink.

Leave a Reply

Your email address will not be published. Required fields are marked *