Healthy Skepticism Library item: 479

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: news

Bowe C.
Anti-depressant hearings set for this month
Financial Times 2004 May 5

Full text:

A House of Representatives subcommittee is planning to hold hearings in the first half of this month to address questions on the potential for anti-depressants to cause suicidal behaviour in children.

The Oversight and Investigation subcommittee, led by James Greenwood, the Pennsylvania Republican on the House Energy and Commerce committee, intends to gather information on the use of anti-depressants by children, potential safety consequences and US regulatory research into safety issues.

Also, the subcommittee will gather information on the circumstances of an internal recommendation made by a Food and Drug Administration researcher.
Considerable interest has focused on allegations that FDA senior officials barred Dr Andrew Mosholder, an FDA scientist, from releasing his recommendation that anti-depressants increased the risk of suicidal tendencies in young people. He also recommended immediate further regulatory warnings about their use by minors.

Dr Mosholder found that the drugs, particularly selective serotonin reuptake inhibitors (SSRIs), continue to pose questions about risk of side- effects, especially in children.

He also raised questions about the regulators’ review of trial data and safety warnings from such data.

In May, Columbia University’s Division of Child and Adolescent Psychiatry released a study showing parents’ worries about depression medication.
About 68 per cent of parents feared that anti-depressants were over- prescribed to young people, according to the study conducted by the Carmel Hill Center for Early Diagnosis and Treatment at the university.

However, while 31 per cent of parents considered anti-depressants harmful to adolescents, 69 per cent thought the drugs were not harmful or did not know.
More than half the parents responded that teenagers received treatment for depression without being clinically depressed.

Prior to a February regulatory advisory committee meeting to weigh the risks of anti-depressants and suicide, Dr Mosholder completed a review of clinical trials. He concluded that anti-depressants could be linked to increased suicidal tendencies in children and recommended regulators act.

But he was prevented from presenting that view to the advisory panel.
Senator Charles Grassley, Republican from Iowa, wrote to regulators that Dr Mosholder was given a “script to read”.

The FDA began an investigation aimed at identifying the leak of the Mosholder report, according to a congressional source.