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Drugs (Pharmaceuticals)

Children and Youth

Suicides and Suicide Attempts

Food and Drug Administration

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Antidepressants Restudied for Relation to Child Suicide

Published: June 20, 2004

(Page 2 of 2)

"For all of us, our anxiety levels are higher because we know that there are people invested in this one way or the other,'' said Dr. Madelyn Gould, professor of clinical public health in psychiatry. "Anything that has to do with drug treatment in kids is so emotionally charged.''

The study had its beginnings early last year when GlaxoSmithKline submitted to federal drug regulators the results of three trials of its Paxil antidepressant in teenagers and other children. The company had undertaken the studies to take advantage of a federal law that delays by six months the introduction of cheaper, generic versions of drugs when branded makers test medicines in children.


In GlaxoSmithKline's trials, depressed young people given Paxil fared no better than those given placebos. It was a disappointing result for GlaxoSmithKline but had no effect on its application for the six-month extension. Still, a reviewer at the Food and Drug Administration noticed something strange about the trials: teenagers given Paxil suffered more problems of ''emotional lability,'' or instability, than those given a placebo.

The reviewer, Dr. Andrew Mosholder, thought ''emotional lability'' was overly broad. He asked the company to resubmit its data, this time using a separate category for suicide.

That report, given in May to both American and British health authorities, was alarming. Teenagers and younger children given Paxil were much more likely to become suicidal than those given placebos. In June, both the British and American authorities warned doctors against prescribing Paxil to youngsters. Worried that the problem could extend far beyond Paxil, the F.D.A. in July asked the makers of eight other antidepressants to submit data from their studies in youngsters.

In August, Wyeth issued a warning that doctors should avoid prescribing Effexor to youngsters because it, too, seemed to cause them to become more suicidal.

By September, the agency had received the other companies' studies. Looking at them all, Dr. Mosholder concluded that children given antidepressants were almost twice as likely as those given placebos to become suicidal. He suggested the agency discourage the drugs' use in children.

It would have been a monumental step. Antidepressants are among the biggest-selling drugs in the world and have long been viewed by doctors as relatively safe. Their use in children has been soaring.

Dr. Mosholder's bosses at the Food and Drug Administration, however, said the drug company data was inconsistent and that some events termed ''possibly suicidal'' seemed innocent. Top agency officials hired the Columbia researchers to review the data, and they forbade Dr. Mosholder to speak about his conclusions to an advisory panel reviewing the matter.

The silencing of Dr. Mosholder prompted outrage among critics of antidepressants and the ongoing investigation by Senator Grassley. It also has fostered skepticism about the Columbia study. Already, Internet postings are questioning the backgrounds of the Columbia researchers. One asks whether Kelly Posner, the lead investigator, has participated in trials financed by the drug industry.

In a group interview in a conference room in the New York State Psychiatric Institute, the researchers said they were unbiased.

Dr. Posner said that she had participated in some trials sponsored by drug makers but never as a principal investigator. All of the trials involved attention deficit disorder, not depression or suicide, she said.

Her three colleagues said that they had never taken part in a drug-company trial. And they said that their study, while hugely controversial, was relatively simple: figuring out the appropriate labels to place on the behaviors in the individual cases.

"We're just dealing with a lot of pieces of paper,'' Dr. Gould said. "We're not dealing with people at all. And all the interesting questions happen once we give the data over to the F.D.A.,'' where the statistical analysis will occur.

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