Agency Itself Has Final Say on Approval
by John Kelly
An expert panel for the U.S. Food and Drug Administration (FDA) has approved the marketing of three psychotropic medications for use by mentally disturbed youth, a path of treatment that is already heavily relied upon by some child welfare and juvenile justice systems.
The Psychopharmacologic Drugs Advisory Committee said this month that it supports a request by the manufacturers of Zyprexa, Seroquel and Geodon to market the drugs as effective and acceptably safe for treatment of bipolar disorder and schizophrenia among youth.
The decision to approve the drugs now rests with the FDA, an action which some observers believe that approval could lead to more prescriptions for the drugs to youth.
Here are the three drugs up for discussion, their makers and the prescribed use for which the maker sought approval:
Zyprexa. Eli Lilly. “For the acute treatment of manic or mixed episodes associated with bipolar I disorder and the acute treatment of schizophrenia in adolescents.” Lilly agreed to pay the U.S. government $1.4 billion to settle criminal and civil cases regarding its promotion of Zyprexa for use with the elderly and children. Zyprexa is one of the three drugs that was prescribed to Gabriel Myers, a 7-year-old Florida foster child who is believed to have committed suicide. Myers’ death prompted the Florida Department of Children and Families to examine the use of psychotropic medication by children in the agency’s care.
Seroquel: AstroZeneca. “For the acute treatment of schizophrenia in adolescents from 13 to 17 years of age, and the acute treatment of bipolar mania in children from 10 to 12 years of age and adolescents from 13 to 17 years of age.”
Geodon: Pfizer. “For the acute treatment of manic or mixed episodes associated with bipolar disorder, with or without psychotic features in children and adolescents ages from 10 to 17 years of age.”
What Could Change
Doctors are not prohibited from prescribing the medications to youths now, but must do so off-label. Informal studies have yielded some positive results in youths, but the side effects of these three drugs and others in the “atypical antipsychotics” family include significant weight gain and Type II diabetes.
Official approval to market the drugs might ease concerns of state Medicaid and Medicare agencies about paying for the drugs, said David Cohen, a psychotherapist and professor at Florida International University.
“The bulk of sales [for psychotropic drugs] have been from government programs,” namely Medicaid and Medicare, Cohen said. It is possible that state Medicaid agencies, which are directly involved in expenditures for youths in the child welfare system, “will lessen their scrutiny of the drugs if they’re approved.”
“I believe the approval, should it officially come from the FDA, will counter the very recent drop in sales,” said Cohen.
Psychologist Ronald Brown, who made a statement to the committee on behalf of the American Psychological Association, indicated that an association working group on such drugs yielded little evidence that they were successful in treating youth, while there was little doubt that they carried significant risk of serious side effects. Brown did not ask the committee to reject the applications.
“Of the few pediatric studies that do exist, many include small samples sizes and attendant methodological weaknesses,” said Brown, the dean of public health at Temple University.
Speaking with health trade paper HealthDay before the committee voted, however, Brown said his own view was that the applications should not be approved.
“Particularly with children, when you don’t know, I don’t think you should approve it,” Brown said. “In this country, we are very overzealous to approve drugs. I think we need to be more conservative, particularly because this is a pediatric population.”
The use of psychotropic medications is high among youth involved in state systems such as child welfare and juvenile justice. About 14 percent of youth in foster care are prescribed a psychotropic medication, according to a policy paper written in 2006 by the Institute for Juvenile
Research at the University of Illinois at Chicago. But only 1 to 3 percent all youth suffer from bipolar disorder and schizophrenia, according to Dr. David Fassler, a clinical professor of psychiatry at the University of Vermont College of Medicine.