E-DRUG: GSK 'held back' data on SSRI drug for children (2)
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[Here is a link to today's article in the BMJ, about the Paroxetine - data
withholding scam. The company (GSK) knew, already in 1998 that Paroxetine
had no benefit in treating adolescents!! Thanks to Shanti for spotting this.
Copied as fair use. WB]
http://bmj.com/cgi/content/full/328/7437/422-a?ecoll
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."
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