AR-News: Drug failure kept secret

Wed Feb 25 21:35:42 EST 2004

From: "- V I N -" 
http://bmj.bmjjournals.com/cgi/content/full/328/7437/422-a?etoc

BMJ  2004;328:422 (21 February),
doi:10.1136/bmj.328.7437.422-a

News
GlaxoSmithKline staff told not to publicise
ineffectiveness of its drug
David Spurgeon
Quebec

CMAJ (the journal of the Canadian Medical Association)
has published details of an internal document from the
drug company GlaxoSmithKline that advised its staff to
withhold the findings of a clinical trial in 1998
showing that the antidepressant paroxetine had no
benefit in treating adolescents.

The association has publicised the document on its
website in an early release of its Analysis column
(www.cmaj.ca).

Last year, the drug, which is marketed as Paxil in
North America and Seroxat in the United Kingdom, was
banned for paediatric use in several countries because
of a perceived increased risk of suicide.

The UK Medicines and Healthcare Products Regulatory
Agency advised doctors last June that they should not
prescribe the drug to patients under the age of 18.

The CMAJ column says the confidential document was
prepared by the central medical affairs team, a
division of SmithKline Beecham, the company that
subsequently merged with GlaxoWellcome to form
GlaxoSmithKline. The column says the document gives
guidance on two clinical trials, study 329 and 377,
whose results were, according to the document,
"insufficiently robust" to support application to
regulatory authorities for a label change approving
Seroxat for use in children and adolescents.

The team recommended the firm "effectively manage the
dissemination of these data in order to minimize any
potential negative commercial impact."

Study 329, conducted in the United States from 1993 to
1996, showed paroxetine to be no more effective than a
placebo, while study 377 showed that the placebo was
"actually more effective than the anti-depressant."

The central medical affairs team's document is quoted
as saying that "it would be commercially unacceptable
to include a statement that efficacy had not been
demonstrated, as this would undermine the profile of
paroxetine."

A spokeswoman for GlaxoSmithKline, Jill
McKinlay-Morris, told the CMAJ that "the memo draws an
inappropriate conclusion and is not consistent with
the facts... GSK abided by all regulatory requirements
for submitting safety data. We also communicated
safety and efficacy data to physicians through
posters, abstracts, and other publications."

Animal experiments have:
a 63% failure rate when detecting human carcinogens
a 75-95% failure rate for detecting drug side effects
a 70% failure rate for detecting drugs which cause birth defects
Success rates lower than those achieved by uneducated guesswork.

This is not science!!

Recommended website: The Absurdity of vivisection
http://vivisection-absurd.org.uk/

Information on animal research available free by EMail from 
vivisectionkills at hotmail.com

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Indeed, it's the only thing that ever has."      Margaret Mead
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