I am addressing two (2) issues related to the effectiveness and safety of the prescription of Selective Serotonin Reuptake Inhibitors (SSRIs) to children:
What is the human cost, in terms of morbidity and mortality, when SSRIs are prescribed without adequate clinical trials and 'off-label' to children?
Specific Example: 13 y.o. Caucasian male child with a diagnosis of dysthymia. The boy was brought to the attention of a psychiatrist because of social isolation and inability to make friends easily. Prior to seeking psychiatric attention, he had never been psychiatrically hospitalized nor had he experienced suicidal or homicidal feelings. He had no history of acting out against others. He had been considered mild-mannered, quiet, friendly, shy and uncomfortable in social situations with children his age. He had no medical diagnoses.
The boy's psychiatrist prescribed escalating doses of paroxetine (PAXIL). As his mood deteriorated and his behavior worsened, the psychiatrist increased the dose of Paxil from an original dose of 10 milligrams per day to a final dose of 60 milligrams per day. He required inpatient psychiatric hospitalization twice over a period of one month due to increasingly self-destructive thoughts and self harm (he broke his own arm; tried to hang himself) and demonstrated severely aggressive acting-out against others (while walking in his neighborhood with his mother, he violently attacked a stranger, biting the stranger's forearm and breaking the stranger's forearm skin with his teeth.)
After his act of aggression, he was re-hospitalized. His inpatient child psychiatrist lowered his dose of Paxil to 40mgs per day and added quetiapine (SEROQUEL, an atypical antipsychotic), to decrease his "psychotic symptoms" and stabilize his mood.
I will report on the current status of this boy and comment on a few of the important points that can be gleaned from its exposure. Those points include:
The Registry of Clinical Trials is an essential step - and absolutely necessary - to safe-guard the clinical research of all neuropsychiatric medicines and devices. However, although it is necessary, it is NOT sufficient.
What else do we need to protect the health and welfare of children, adolescents, and adults?
Clinical 'SPIN' must be addressed
The results and conclusions of any trial, including the abstracted information, must not be distorted in follow-up clinical research publications or marketing efforts. The reasons for this are simple. If the end result of a valid clinical trial shows a drug, for example, to be ineffective, that result must not be reported as 'somewhat effective' elsewhere. To do so invalidates the importance of the publication of clinical trial results and minimizes the promise and potential of the clinical registry.
Stefan P. Kruszewski, M.D. is a clinical/academic psychiatrist from Harrisburg, Pennsylvania. He is certified by the American Board of Psychiatry and Neurology in general and psychiatric subspecialties as well as by the American Society of Addiction Medicine and the American Board of Adolescent Psychiatry. He has had solo-authorship work published in the New England Journal of Medicine, Journal of Clinical Psychiatry, Archives of Family Medicine, Plant Physiology, as well as in the New York Times, Barron's and other newspapers.
Dr. Kruszewski graduated from Princeton University and Harvard Medical School. He completed a residency in psychiatry and post-doctoral work in clinical research at Robert Wood Johnson Medical School and did post-residency work at Duke University and Texas Christian University.