GlaxoSmithKline knew that the anti-depressant Seroxat could not be
proved to work on children in 1998, according to a leaked internal
The secret document, relating to two clinical trials held in the
1990s, reveals that drug trials had shown little or no effect on
helping depression in minors.
The company was also advised to avoid publishing the full data
because it would be "commercially unacceptable" and would "undermine
the profile" of the drug.
The confidential paper, sent anonymously to BBC's Panorama
programme, reveals that the company were advised to publish only the
positive aspects of one study and that there were no plans to
publish a second - more negative - study.
It also urged GSK not to send the data to the regulators because
they would have had to include a statement about the effectiveness
of the drug.
Last year, government advisors said that Seroxat should not be
prescribed to children. The Committee for Safety in Medicine
concluded that the risks outweighed the potential benefits after
receiving new research from GSK.
The target of the confidential paper was to: "effectively manage
the dissemination of these data in order to minimise any potential
negative commercial impact."
It was produced by the Central Medical Affairs team, a division
within SmithKline Beecham (the name GSK was known as in 1998), with
the job of managing issues across their portfolio of drugs.
The document claims that in one trial the drug was no more
effective in reducing depression in minors than a placebo pill. In a
second study, the placebo drug seems to be more effective in
combating feelings of depression in teenagers.
It was concluded "it would be commercially unacceptable to
include a statement that efficacy had not been demonstrated."
The company was also worried that such a statement would
"undermine the profile of paroxetine (Seroxat's medical name)."
The document recommended that GSK publish only the positive data
from one of the studies (study 329). This report was made publicly
available in July 2001.
This study was conducted within the USA from 1993 until early
1996. It was the single biggest trial of any of the family of
anti-depressants known as selective serotonin reuptake inhibitors,
undertaken in children.
The results showed that while Seroxat did seem to work across all
types of depression, it failed to show that it was significantly
more effective than a placebo pill.
A second study (Study 377) was carried out over 12 weeks across
Europe, South America, South Africa and Saudi Arabia.
The results of this trial - which has never been published,
although it was orally presented in 1999 - found that children
responded better to the placebo than to Seroxat.
Panorama first raised concerns about the safety of the drug
Seroxat in October 2002. It has made two award winning films about
the potential side effects of the drug and problems that some people
have had withdrawing from it.
Dr Alistair Benbow, head of European Clinical Psychiatry for
GlaxoSmithKline, said: "The memo draws an inappropriate conclusion
and is not consistent with the facts.
"All of the safety data was submitted to the US and European
regulatory authorities and was publicly presented in a timely way.
In fact safety data from study 329 had already been submitted to the
regulatory authorities and had been presented publicly before this
document was written."