Expert Kept From Speaking at Antidepressant Hearing

According to a New York Times report, Top Food and Drug Administration officials have admitted that they barred the agency's top expert from testifying at a public hearing about his conclusion that antidepressants cause children to become suicidal because they viewed his findings as alarmist and premature.

Dr. Andrew D. Mosholder, an agency epidemiologist, was the man charged with analyzing 22 studies involving 4,250 children and seven drugs. In a carefully argued, 33-page memorandum, he concluded that children given antidepressants were almost twice as likely as those given placebos to become suicidal.

The controversy had its start when GlaxoSmithKline sought a six-month extension to its patents on Paxil. To help guide pediatricians' prescribing habits, federal law grants such extensions when companies test their medicines in children.

The company's studies in depressed children failed to show any positive effect. It was a disappointing finding, but patent extensions are granted even when studies fail. Reviewing the data, Dr. Mosholder noticed in October 2002 that they showed a disturbing number of problems listed under the category, "emotional liability." Suicidal thoughts and self-injurious behavior were among the things lumped into this category. Dr. Mosholder asked GlaxoSmithKline to provide more detail about these cases, according to one of the documents.

In May 2003, the company submitted a new report. It showed that children given Paxil were more likely to become suicidal than those given placebos. In June, the agency announced that doctors should avoid using Paxil in depressed children.

Three days later, according to documents and interviews, the agency asked for similar data from the makers of Prozac, Zoloft, Luvox, Celexa, Wellbutrin, Effexor, Serzone and Remeron.