Skip to content

A WORD OR TWO ON PSYCHIATRIC RESEARCH IN CHILDREN

“CUM GRANO SALIS”

The division between clinical and research psychiatry, especially in children, has been recently emphasized in the controversy about using antidepressants in children and the efficacy of antidepressant treatment in bipolar disorder. In an editorial in the current American Journal of Psychiatry distinguished child psychiatrist, Cynthia Pfeffer—“The FDA Pediatric Advisories and Changes in Diagnosis and Treatment of Pediatric Depression”—observes that research between 1990 and 2000 showed a decrease in suicide among children treated with antidepressants. Click here to read Pfeffer’s editorial Pfeffer goes on to note that a more recent study confirmed the benefits of combined psychotherapeutic and pharmacologic treatment of depressed children. [March J, Silva S, Petrycki S, Curry J, Wells K, Fairbank J, Burns B, Domino M, McNulty S, Vitiello B, Severe J: "Fluoxetine, cognitive-behavioral therapy, and their combination for adolescents with depression: Treatment for Adolescents With Depression Study (TADS) Team"JAMA 2004; 292:807–820].

However, “the U.K. Medicine and Health Care Products Regulatory Agency advised on June 10, 2003, that paroxetine [Paxil] not be prescribed for anyone under 18.” The British directive was based on a large retrospective study, a review of outcomes of a combined group of older studies. [click her for a summay of the British study] By October of 2004, based on mere statistical re-analysis, the FDA require pharmaceutical companies to provide a grave, “black box” warning for all antidepressants, warning about their danger to children.

Pfeffer observes: “Prior to the FDA’s October 2003 advisory, rates of depression diagnoses made by pediatricians and nonpediatrician primary care physicians steadily increased and accounted for the majority of diagnoses of pediatric depression. After the advisory, rates of diagnosing pediatric depression significantly decreased among primary care physicians, were unchanged among pediatricians, and significantly increased among psychiatrists. Prior to the advisory, 59% of depressive episodes were associated with an SSRI prescription filled within 30 days of diagnosis, and the rate increased significantly over time. After the advisory, the percentage of SSRI prescription fills after diagnosis gradually but significantly decreased, and by 2005, SSRI prescriptions were filled for only 28% of episodes.”

In other words, despite previous studies indicating that treatment with medication, and especially with medication and psychotherapy, resulted in children with depression being safer and more able to carry on developmentally, the (unintended) consequence of the British study and the FDA reaction to it has been a significant decrease in the diagnosis and treatment of depressed children. How should a parent respond to such conflicting opinions among experts?

My thoughts are these:

  • Psychiatric research is quite different than clinical observation.
  • Positively, psychiatric research bases itself on a far larger number of cases and commands a broader perspective. Research is also usually conducted under carefully controlled conditions.
  • Negatively, psychiatric research arrives at the diagnosis and treatment of its subjects broadly as well. Rarely are the details of family history, developmental history, or the relationship between the doctor and patient weighed. Also the conditions of treatment, although carefully controlled, are controlled to provide statistical clarity. They are not always clinically optimal. In retropective studies, such as the ones done by the U.K. Medicine and Health Care Products Regulatory Agency and the FDA, the criteria for diagnosis, criteria for inclusion and exclusion, and the treatment protocols may differ among the studies gathered together for statistical review. The numbers being crunched are not comparable with one another.
  • Clinical observation bases itself on subtleties that are only available with personal and family contact, and within an ongoing relationship with both parents and child.These observations include subtle observations of a child’s behavior as well as their symptoms, academic function, developmental history, family history, relationships between the child and the family, and knowledge of psychosocial stressors affecting a child. Clinical observation also is ongoing, from year to year, not simply for a matter of weeks or months. In appropriate pharmacologic care there is also the possibility of working with several medications with the opportunity to change one but not all if negative effects are seen. Such subtelty is not usually an option in research.
  • Negatively, clinical observation can vary widely depending on the skills of the clinician, not only in prescribing medication but also in maintaining a relationship with parents and child, and with other people involved in caring for or educating the child. Clinicians possing this combination of skills are rare.

Finally, psychiatric illness is importantly different than other medical illness because it affects vastly more than a child’s biology. Quite separately from religious definitions, psychiatry deals with the soul of a person, the psyche: an individual, unquantifiable, exquisitely reactive reality. If one is more comfortable with the words personality, character or self, I have no difficulty with those terms, as long as their inherent subjectivity is preserved. In the end, good research strives to be objective; good clinical work strives to be supremely subjective.

Post a Comment

You must be logged in to post a comment.