Issued – Tuesday 26 February 2008, London, UK

Untreated, major depressive disorder can have serious consequences, with devastating impact, for patients and their families. The lack of effective care and the continued social stigma associated with mental disorders remain fundamental barriers to diagnosis and treatment of depression.

We are therefore disappointed at how this study has been reported and believe that it has caused unnecessary alarm and concern for patients. Patients should not stop taking their medicine before discussing their situation with their doctor. Antidepressant medicines remain an important option, in addition to counselling and lifestyle changes, for patients suffering from depression.

Regarding the study, we strongly believe that the authors’ interpretation is incorrect and is clearly at odds with the benefits of antidepressants routinely observed in actual clinical practice.

It is important to emphasise that regulatory bodies around the world have conducted extensive reviews of published and unpublished data for licensed antidepressants and have concluded that these medicines provide benefit to patients.

Contrary to what has been reported, this study has only examined a small subset of the total data available for antidepressants. With paroxetine for example, this study only considers data from 16 trials out of a total database of more than 170 trials involving at least 14,000 patients. Clinical studies assessing clinical benefit in depression are complex and it is important to note that paroxetine trials overall met the regulatory standard for efficacy, and 10 of the 16 trials in this analysis also met the NICE clinical threshold of 3.0 points.

In the case of paroxetine, all trial data published and unpublished were submitted to regulators, at the time of registration. GSK fully endorses public disclosure of clinical trial results for its medicines and is actively committed tocommunicating data relevant to patient care. All the data related to GSK’s clinical trial results of paroxetine, regardless of study outcome, are available the company’s clinical trials register on www.gsk.com.

Enquiries:

Addendum - Quote from a GSK Spokesperson:"GSK rejects any suggestion that we deliberately withheld data on paroxetine from NICE. GSK provided both published and unpublished data as part of the development of the NICE guidelines regarding the licensed use of paroxetine in adults with depression, anxiety disorder, post traumatic stress disorder and obsessive compulsive disorder. In addition GSK responded to a request for data on the use of paroxetine in children. The company provided a list of the studies that had either been completed or were underway however this was an unlicensed indication (that is to say the product was not approved for use in this patient population) and was subject to an ongoing regulatory review by the MHRA. It was therefore not appropriate to provide these data to NICE ahead of the MHRA's conclusions."