"These Drugs Are Not Chocolate Ice Cream"
by Melissa Bailey | May 30, 2006 01:37 PM | Permalink
A Yale study that gave powerful antipsychotic drugs to adolescents failed to produce the meaningful results it sought. It did produce criticism over how the study's controversial approach puts children at risk, and whether that risk is justified.
The study raised tough questions: How soon is too soon to give adolescents powerful antipsychotic drugs? How about when they have not developed a mental illness, but seem headed down that path? Would the hope of averting a devastating psychotic breakdown outweigh the risk of side effects from possibly needless drug treatment?
The study, headed by Yale’s Dr. Thomas McGlashan and funded by the National Institute of Mental Health and the pharmaceutical giant Eli Lilly, was published earlier this month in the American Journal of Psychiatry. Researchers at Yale and three other clinics recruited "help-seeking" patients, mostly adolescents, who hadn’t developed schizophrenia but appeared to be on that path. The subjects, aged 12 to 36, responded to ads or were referred by clinicians.
Half the patients were treated with Eli Lilly’s antipsychotic drug Zyprexa Olanzapine. The other half was given a placebo. Investigators asked: Can early drug treatment prevent psychosis?
Unfortunately, low recruitment numbers and a high dropout rate — 60 entered the study, and over two-thirds dropped out — left so few patients that researchers could not reach a definitive answer. The only conclusion they drew was that the drug might be able to delay psychosis, but likely can't prevent it.
The study has drawn heat from patient watchdogs and bioethicists who question if kids were exposed needlessly to the drugs. Zyprexa can have serious side effects — weight gain, diabetes, and seizures. Also, a Boston Globe investigative piece reported that the suicide rate in the clinical trials of Zyprexa and two similar drugs was "two to five times higher than the norm."