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Drug firms withheld negative data -study
Fri Apr 23, 2004 08:05 AM ET
LONDON, April 23 (Reuters) - Drug companies withheld information showing antidepressants were ineffective and could be harmful to children and should have issued warnings on their products, researchers said on Friday.
Health authorities in Britain and the United States have voiced concern or advised doctors not to prescribe the drugs known as selective serotonin reuptake inhibitors (SSRIs) to children under 18 because of a potential suicide risk.
Scientists who conducted a review of six published and six unpublished trials about their use in children say companies had been aware of problems but did not reveal them.
"They have this data sitting in front of them (showing) that the drugs don't work and there is some risk that they will increase suicidality in children. Why didn't they just put a health warning saying 'don't use in children'" asked Dr Tim Kendall, of the National Collaborating Centre for Mental Health (NCCMH) in Britain which produces guidelines to improve patient care.
"It is morally their responsibility, especially when it comes to children, that if they have data to show their own drugs don't work and/or are dangerous they should make that public," Kendall added.
Most SSRIs are not specifically licensed for use by under-18s but are still prescribed off-label.
The drugs in the review included GlaxoSmithKline Plc's (GSK.L: Quote, Profile, Research) Seroxat/Paxil. In a memo from GlaxoSmithKline, leaked last month and published in a Canadian medical journal, the company said negative trial results could not be released because it would damage the profile of the drug.
There was no immediate comment from GlaxoSmithKline but in the past the company has said it believes its drug is safe and effective.
Had the review been limited to published data, the scientists would have recommended the drugs in their guidelines. But with the inclusion of the unpublished data they reached the opposite conclusion.
The analysis of both sets of data, published in The Lancet medical journal, found the risks exceeded the benefits in all the drugs except Eli Lilly and Co's Prozac.
Kendall called for new regulations to allow organisations that
investigate the best treatments for illnesses to have access to all
information companies have about their products.
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