GSK investigation concludes

The MHRA has concluded its investigation into GlaxoSmithKline (GSK) and its antidepressant drug, Seroxat.  A press release and accompanying documents are available below.

Documents released under the Freedom of Information Act
The documents being published today include three sets of papers dating from May and June 2003, and consist of:

• the clinical trial data analyses provided by GSK, as referred to in Section 1 of the report being published today, 'MHRA Investigation into Glaxosmithkline/ Seroxat' (para 9ff); and
• the MHRA’s assessment reports on those analyses, as provided to the Committee on Safety of Medicines and sub-group on SSRIs (Selective Serotonin Reuptake Inhibitors).

They are being released under provisions in the Freedom of Information Act 2000. Any redactions in the documents relate to names of individuals, and are withheld under either exemption 38 or 40 of the Freedom of Information Act 2000.

Aside from these redactions of names, the MHRA consider that, in line with the provisions of the FOI Act, the public interest in disclosing the information contained in the documents outweighs the public interest in maintaining its confidentiality.