ABSTRACT

The old adage 'all publicity is good publicity' must surely be wearing thin for the pharmaceutical industry, especially for GlaxoSmithKline (GSK) which has been hit by a wave of adverse publicity and falling share prices following litigation in the USA over the safety of its anti-depressant. Both the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK and the Food and Drug Administration (FDA) in the US have failed to take sufficient action on evidence that Seroxat. The serotonergic system has been associated with the brain's emotional centre since the 1980s, making serotonin an obvious target for investigation by the pharmaceutical industry in the quest for the next generation of anti-depressants. Licensing applications by pharmaceutical companies must be supported by the disclosure of all clinical trials conducted so that efficacy and adverse effects may be evaluated. The FDA has repeatedly denied receiving disclosure of the relevant control data.