|
Drug Firms Withheld Negative Data
Drug
companies withheld information showing antidepressants were ineffective
and could be harmful to children and should have issued warnings
on their products, researchers said.
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of six published and six unpublished trials about their use in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 Center 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 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 But with the inclusion of the unpublished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 organizations that investigate the best treatments for
illnesses to have access to all information companies have about
their products.
Related articles:
Reference
Source 89
For more information on how to prevent other diseases, use
PreventDisease.com's "Quick
Prevention Resources".
|
