Is GSK guilty of fraud?
NB. Please note that if you are outside North America, the embargo for LANCET press material is 0001 hours UK Time 11 June 2004.
This week's editorial calls on GlaxoSmithKline (GSK) to make all its research on paroxetine (Seroxat/Paxil) publicly available. This follows the filing of last week's law suit by the state of New York against GSK: the state accuses the company of fraud, by depriving consumers of the information they and their doctors need to make informed decisions about treatment, and seeks the return of all profits obtained through fraudulent means.
Paroxetine is not licenced for use by adolescents or children in the USA or Europe; however, 'off-label' prescribing is not uncommon if a physician perceives there to be benefit to patients. The drug's safety and efficacy in children have been tested in at least five studies sponsored by GSK, only one of which has been published; its results were mixed. Results from other unpublished trials were either mixed or showed no benefit.
The editorial concludes: 'This contest ought to follow the example set by recent tobacco-company litigation. GSK must create a public archive of all documents relating to paroxetine in under-18s. If GSK has nothing to hide, as it claims, it should open its files before being ordered to do so by a court-and do so right now.'
Source: Eurekalert & othersLast reviewed: By John M. Grohol, Psy.D. on 21 Feb 2009
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