New doubts about medicating kids

Pressure is mounting to ban or curtail the use of antidepressants on children. An FDA panel heard evidence this week.

Personal tragedies and scientific evidence are combining to call into question the use of powerful antidepressant drugs on children and teens.

Pressure has been building for months to ban or curtail their use. Recent scientific studies have found a link between the use of these drugs and suicidal tendencies among children. In December, Britain banned the use of some antidepressants on patients under 18. The fallout from a hearing called by the Food and Drug Administration (FDA) this week is ratcheting up the pressure for some kind of action on this side of the Atlantic.

"Until I went to the conference, I felt I would be out of step with my colleagues not to" prescribe these drugs, said Lawrence Diller, a pediatrician from Walnut Creek, Calif., in a telephone interview after the hearing. Parents and even children themselves expect to be given a pill today, he says. But "I think pediatricians are going to be much more careful after hearing about this," by either writing fewer prescriptions or monitoring the children more closely.

Dr. Diller - author of the book "Should I Medicate My Child?" - was one of several physicians and researchers who testified at the hearing outside Washington Monday. The advisory panel also heard from numerous grieving parents and relatives whose children had either killed or injured themselves or others while taking prescription antidepressant medications. Meanwhile, one presentation from researchers showed the drugs to have little or no more effectiveness than placebos - sugar pills.

The FDA had been planning to issue a report on the drugs next summer. But the advisory panel urged the FDA to act now to warn doctors and parents. While the warning wouldn't place a ban on prescribing such drugs, it would caution both physicians and parents to watch for signs that the drugs might be having a harmful effect.

"Our sense is that we would like, in the interim, the FDA to go ahead and issue stronger warning indications to clinicians regarding possible risks of these medicines," said Dr. Matthew Rudorfer, a scientist at the National Institute of Mental Health and the chairman of the FDA advisory committee. "We think such warnings are required to elevate the level of concern and attention that practitioners use in prescribing them.... We want to put a speed bump in the road."

About 40 relatives of children who had taken antidepressant drugs testified at the hearing that they believed the prescribed drugs had had tragic consequences.

Parent Sara Bostock, said that after two weeks of taking Paxil her daughter fatally stabbed herself with a kitchen knife. "To die in this violent and unusual fashion ... led me to believe Paxil must have put her over the edge," Ms. Bostock said.

Another parent, Mark Miller of Kansas City, Mo., said his 13-year-old son, Matt, hanged himself after taking seven Zoloft pills. "You have an obligation today ... [to prevent] this tragic story from being repeated over and over again," he said.

Two parents testified that they thought the drugs had helped their children and urged the FDA not to ban them.

Diller and others are also concerned that scientific studies about the drugs have either been suppressed or misinterpreted.

Diller says he spoke in his testimony about his "loss of faith in my academic colleagues to generate accurate information and opinions that I feel I can trust because of the extremely intimate link between researchers and the drug industry."

After such revelations, he says, one might expect closer regulation of the medical profession. But "we don't have to worry about regulation of doctors because the government has been bought off and so has the public by the drug industry," he says. "The ads directed to consumers convince everyone that life is simply, you know, neurotransmitter bubbles going from one set of synapses to another. The lobbying of the drug industry is legendary - and this is a doctor speaking."

Another testifier, David Antonuccio, a psychologist at the University of Nevada Medical School in Reno, was part of a team that analyzed 12 studies (published and unpublished) on antidepressants and children. "Our conclusions were that the advantages of the antidepressants in children were so small and so trivial as to be clinically insignificant," Dr. Antonuccio said by telephone after the hearing. They certainly do not "warrant any increased risk, let alone increased risk for suicidal behavior.

"We don't think the benefits warrant [even] some of the [lesser] side effects, which are quite common, including agitation, insomnia, and gastrointestinal problems."

His team's preliminary analysis of available studies shows that "placebos duplicate 90 percent of the drug response," which suggests that the drugs' benefit is primarily psychological. Less risky strategies such as "exercise, cognitive-behavior therapy, depression-management skills, sports, or just good parenting" should be considered first, he says, adding that, speaking as a father of a 5-year-old, "this is a really important issue when it comes to protecting our children."

Britain cited health risks when it banned six brands of antidepressants for children under 18. In the United States, only Prozac has been deemed effective by the FDA in treating children for depression, but doctors are legally free to prescribe other antidepressants and have been doing so routinely.

In October the FDA alerted doctors to reports of suicidal tendencies found among children participating in clinical tests of antidepressant drugs. Wyeth, the pharmaceutical company that makes the antidepressant Effexor, had warned doctors in August that its drug caused an increased risk of suicidal behavior in children.

Antidepressants are heavily advertised by drug companies to the general public and are used to treat depression, obsessive-compulsive disorder, social phobias, and anxiety disorders.

The drugs are classed as SSRIs or selective serotonin reuptake inhibitors. Millions of prescriptions for them are written each year. The FDA says that more than 10 million children and teens 17 and under took antidepressants in 2002. The drugs under review by the FDA are known by the brand names Remeron, Serzone, Effexor, Wellbutrin, Celexa, Luvox, Paxil, Zoloft, and Prozac.

The Pediatric Research Equity Act of 2003, signed into law last November by President Bush, provides the FDA with authority to require studies of the effects of pharmaceutical products specifically on children to ensure that they are both safe and effective.

• Material from wire services was used in this report.