- ABC News has learned that a Massachusetts
hospital is currently recruiting pre-schoolers to test the safety and effectiveness
of a powerful antipsychotic drug called Quetiapine.
- The study, conducted by the Department
of Pediatric Psychopharmacology at Massachusetts General Hospital, is testing
subjects from four to six years of age with Bipolar Disorder. An earlier
Massachusetts General study of the antipsychotic drugs Risperidone and
Olanzapine recruited children as young as three years old.
- These antipsychotic drugs are only approved
for use by adults and are so toxic they carry a "black box warning."
The drugs have been found to cause diabetes; a life-threatening nervous
system problem called Neuroleptic Malignant Syndrome; low blood pressure;
and have also led to higher death rates in the elderly. Despite these serious
potential side-effects, a patient recruitment video obtained by ABC News
contains no mention of any of these risks.
- Vera Hassner Sharav of the Alliance for
Human Research Protection said, "Antipsychotics were never approved
for use in children whose developing brains and central nervous system
may be irreversibly harmed. We believe that physicians who subject children
to the toxic effects of these drugs...are practicing outside medically
- A previous clinical trial of Olanzapine
was conducted by UCLA in 1998 on five children, aged 6 to 11. The authors
of the study said treatment was discontinued within the first six weeks
"because of adverse effects or lack of clinically significant therapeutic
- Sharav also said it's questionable whether
or not three or four year-olds can be accurately diagnosed for Bipolar
Disorder. According to a 1999 Surgeon General report, "The signs and
symptoms of mental disorders are often also the characteristics of normal
development." The National Institute for Mental Health has concluded
that "diagnostic uncertainty...surrounds most manifestations of psychopathology
at such an early age."
- Neither the hospital nor the lead investigator
for the trials, Dr. Joseph Biederman, responded to our requests for a comment
on the trials.
- Go here for information on the Massachusetts
General clinical trial