GlaxoSmithKline (GSK), the UK’s largest pharmaceutical company, was under fire again recently over its antidepressant Seroxat (paroxetine). A recent BBC Panorama investigation alleged that the company hid medical data showing that Seroxat was linked with suicide in children, instead promoting it as safe and efficacious. But the Seroxat debacle is likely to be just the tip of the iceberg, as pharmaceutical companies routinely misrepresent trial results, according to experts.
Seroxat, a selective serotonin reuptake inhibitor (SSRI), was hailed as a wonder drug for adults when it was launched in the UK in 1990. Off-label prescribing in children would widen the drug’s market, so GSK promoted the drug as safe and efficacious in children, despite clinical trial evidence to the contrary, the programme alleged.
GSK’s actions, however, are not thought to be unusual. Yoon Loke, of the School of Medicine, Health Policy and Practice at University of East Anglia, said selective publication of trials and reporting of outcomes are well-recognised phenomena. The only solution, he said, is to mandate trial registration and allow access to the public.
Ida Sim, former project coordinator of the WHO’s International Clinical Trials Registry Platform, agrees. ‘I do believe that the hiding of negative results is likely still going on, albeit less than before, and that additional legislation mandating trial registration and results reporting is indeed warranted,’ she said.
The Seroxat saga has been going on since 2003 when, following public concerns and its own data analysis, the Medicines and Healthcare products Regulatory Agency (MHRA) banned the use of Seroxat in children and launched an ongoing criminal investigation into whether GSK had breached medicines regulations by withholding important data (C&I 2003, 12, 6; 2004, 6, 15; 2004, 18, 10). GSK is now facing several class action lawsuits.
Charles Medawar, of Social Audit, said that critical reviews of the kind undertaken by the Drugs & Therapeutics Bulletin or the Cochrane Collaboration, for example, all help. ‘But what is needed and what is still missing is a general bewareness of how tainted much of the information that we get actually is.’
GSK said it ‘utterly rejects any suggestion that is has improperly withheld drug trial information.’
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