29 janvier, 2007 19:53
Drug firm distorted Paxil test results
Glaxo antidepressant may be linked to suicide in teenagers
Updated: 3:36 p.m. ET Jan 29, 2007
LONDON - GlaxoSmithKline Plc was accused on Monday of distorting clinical trial results of its antidepressant Seroxat, or Paxil, and covering up a link with suicide in teenagers.
The BBC plans to air an episode of the investigative show "Panorama" later saying the drug company attempted to show that Seroxat worked for depressed children despite failed clinical trials and that Glaxo-employed ghostwriters influenced "independent" academics.
A summary of the program was published on the BBC Web site.
"We utterly reject the allegations that are being made in their program," a Glaxo spokeswoman said.
She denied the company had improperly withheld any trial information and said results from pediatric studies were documented and submitted to regulators in accordance with requirements, as well as being presented publicly and published.
Regulators in 2003 recommended against using Seroxat in people under 18 due to an increase in the rate of self-harm and potentially suicidal behaviors in this age group when the drug was prescribed.
But Glaxo said the increase in suicidal thinking was revealed only when results of separate clinical studies were pooled at the end of its research program, at which point the company brought the findings to the attention of regulatory authorities.
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Diagnosing depression |
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Depression is a serious medical illness that comes in many forms with a variety of symptoms. If you have any of the following symptoms for a prolonged period, it may be time to seek help. |
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Persistent sad or anxious mood |
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