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.
"The committee was willing to talk 'openly' with reporters who quite frankly did not know what questions to ask, but a mom who traveled 1,300 miles was not allowed to ask one simple question at the press conference! The vote was already in and I was completely devastated realizing that every child in America is going to be affected by this. That's why I followed Dr. Temple down the hall," she says.
The Psychopharmacologic Drugs Advisory Committee considered in June approval of three "atypical antipsychotic" drugs for use in children: AstraZeneca's Seroquel (quetiapine) for the acute treatment of schizophrenia in adolescents 13 to 17, acute treatment of bipolar mania in children 10 to 12 and adolescents 13 to 17; Pfizer's Geodon (ziprasidone) for the acute treatment of manic or mixed episodes associated with bipolar disorder, with or without psychotic features, in children and adolescents ages 10 to 17 and Eli Lilly's Zyprexa (olanzapine) for the acute treatment of manic or mixed episodes associated with bipolar I disorder and acute treatment of schizophrenia in adolescents. The committee ultimately voted to approve the drugs.
But, according to Kitchens, who admits to calling the FDA "almost every day," bipolar disorder and schizophrenia in children are not even found in the Diagnostic and Statistical Manual of Mental Disorders. "I ask them how can there be hearings to approve drugs for a diagnosis that is not even recognized?" she says. "I understand off-label marketing and off-label prescribing. But now we have off-label diagnosing!"
Kitchens' first radicalizing moment came when a nurse at Laurel Ridge Treatment Center in San Antonio, where Evan was a patient, said that he and the other children were routinely "managed" on Seroquel though it was unapproved for children. Her second was when she got Evan home and discovered he had disabling eye, blood, cardiovascular, endocrine and muscle conditions that have not gone away.
Now Kitchens has thrown herself into developing, with a group of experts, legislation to protect consumers of prescriptions drugs and provide transparency into pharmaceutical industry research--regulation the FDA is "supposed to be doing anyway," she adds.
Another new activist is Kate Miller of Queensbury, N.Y., who regularly has been in touch with the FDA's Dr. Gerald Dal Pan, director of the Center for Drug Evaluation and Research's Office of Surveillance and Epidemiology, since Aug. 4, 2007.
That's when her 15-year-old son, and only child, took his life after being prescribed the popular Merck allergy drug Singulair for hay fever.