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Los Angeles Times
February 02, 2004
Benedict Carey | Times Staff Writer
An FDA panel begins hearings today on claims that some antidepressant drugs trigger thoughts of death in children.
Keeley Schwindt was a high school freshman who became moody and angry, and one day swallowed a massive dose of aspirin to see what would happen.
Kevin Rider was a cerebral 12-year-old who gradually lost interest in his schoolwork and pleasure in his precious Boy Scout activities.
Like millions of boys and girls beginning adolescence, they were diagnosed with depression, and their parents decided to put them on medication.
Soon Schwindt, of Garden City, Kan., was thriving, playing on the basketball team, later heading off to college. Last year, at age 19, she won a teen beauty pageant, and her parents believe antidepressants helped saved the girl’s life.
Rider, of Orem, Utah, wasn’t so fortunate. He had good and bad stretches on the medication. One day, at age 14, he was found dead with a gunshot wound to the head, an apparent suicide that his mother, Dawn Rider, blames on the drugs. “He was not at all a suicidal person, not at all,” she said. “The drugs ended his life.”
In public hearings today a panel of experts convened by the Food and Drug Administration is set to address the underlying question: Could the same drugs that doctors say have helped make life more enjoyable and fulfilling for millions also increase the risk of suicide in some children?
The hearings come weeks after health officials in England effectively banned doctors from prescribing a range of antidepressants to children, citing concerns over suicide risk. As the debate heats up in this country, some psychiatrists say that the uncertainties could vastly alter the treatment of depression in American minors.
“The potential implications of this are enormous, because FDA decisions carry so much weight in terms of what medications are available to patients and families,” said Dr. James McCracken, director of child and adolescent psychiatry at UCLA’s Neuropsychiatric Institute. McCracken said concerns over suicide “are genuinely confusing to many doctors who’ve used these drugs for some time and are comfortable with them. To suggest that the drugs may be harmful for kids is an about-face that is very hard to understand.”
The debate is over how to interpret research on SSRIs (selective serotonin reuptake inhibitors), the popular class of antidepressants that includes Prozac, Paxil and Zoloft. All agree that a risk of suicide shadows any treatment for depression. It’s not just that the disease itself puts a person at increased risk, psychiatrists say; it’s also that effective therapy can lift mood and energy level just enough to prompt someone to action.
Nonetheless, U.S. government researchers who reviewed adult studies of SSRIs decided in the early 1990s that the medications had mostly minor side effects and did not increase suicide risk. Subsequent trials of drugs such as Prozac, Paxil and Zoloft in children and adolescents suggested to most psychiatrists that the drugs were safe and effective in younger patients too.
But no law compels drug manufacturers to publish all the relevant information on a drug, and often negative findings are withheld. In recent years, a raft of previously unpublished information has emerged from SSRI trials in children — convincing some scientists that the drugs are not as safe and effective as initially portrayed.
“What you’re seeing is one of the greatest divides in medicine, between what published articles and their authors say, and what the data actually show,” said Dr. David Healy, director of the North Wales Department of Psychological Medicine in Britain. Healy is one of several researchers who contend that authors of industry-sponsored SSRI trials in children have made the drugs look better than they really are. In one trial, he said, researchers masked serious side effects by noting vaguely that some children became “emotionally labile [changeable],” when actually the youngsters reported thoughts of taking their own lives, what’s known as suicidal thinking.
In its warning on SSRI use in children last December, the British Medicines and Healthcare Products Regulatory Agency, Britain’s version of the FDA, cited evidence of a twofold to threefold increase in suicidal thinking with some of the drugs — from about 1.5% to 3% or more, in some trials. (The agency exempted Prozac from this warning, but the drug is not licensed for use for children or adolescents in England.)
Yet Dr. Graham Emslie, a psychiatrist at the University of Texas Southwestern Medical Center in Dallas, who has conducted dozens of SSRI trials in children, said this evidence amounted to little more than scattered case reports. Emslie heads a task force of specialists reviewing data from some 2,000 children in antidepressant trials. Late in January, the group reported that “taking SSRIs or other new generation antidepressant drugs does not increase the risk of suicidal thinking or suicide attempts.”
Note: A number of internet sites have posted the following paragraph: Kevin Rider, age 14, was withdrawing from Prozac when he died from a gunshot wound to his head. Initially it was ruled a suicide. But two years later, the investigation into his death was opened as a possible homicide. The prime suspect, also age 14, had been taking Zoloft and other SSRI antidepressants.