Adelphi, MD – The most dramatic moment for the 70 doctors and 200 spectators attending June FDA hearings about approving new psychiatric drugs for children came when two bereaved mothers approached the open mike. Liza Ortiz of Austin, Texas, told the advisory panel her 13-year-old son died of Seroquel toxicity in an ICU days after being put on the antipsychotic. “His hands twisted in ways I never thought possible,” she said.
Next was Mary Kitchens of Bandera, Texas, who described Seroquel’s lasting effects on her 13-year-old son Evan after being given the antipsychotic without her knowledge or permission by a residential treatment center. But for Kitchens the most dramatic moment came after the hearings when she approached Dr. Robert Temple, the FDA’s director of the Office of Drug Evaluation, who had officiated on the panel. “Can I show you the stamp on these Seroquel samples that proves my son was given an unapproved drug in 2003?” she asked him, displaying the original drug packaging, which she also showed at open mike. “The panel is considering whether these drugs should be approved for children – and I can show you they’ve been marketed to kids for years!”
“I’m sorry, ma’am – I can’t talk to you,” replied Temple, making a quick getaway. If 44-year-old Kitchens seems angry, she is …
… Cody’s death galvanized the community – and Miller met with FDA representatives in New York Rep. Kirsten Gillibrand’s Washington, D.C., office. Miller also began hearing from other parents, including those in whose children Singulair was producing bipolar and ADHD symptoms.
The tsunami of ask-your-doctor drug advertising that began in 1997 is only one reason branded children’s drugs are selling like breakfast cereal. Another is the desirability to the pharmaceutical industry of the child “customer” – easily administered drugs by parents, doctors and teachers – and likely to stay on them for life, if started young.
But the biggest reason for the rush to medicate children, say health policy analysts, even with drugs known to be dangerous, is private funding for expensive, possibly unnecessary drugs is evaporating and the pharmaceutical industry has turned to public funds to satisfy stockholders. A practice Kitchens and other irate moms says has gone on long enough. (full long 2 pages text).