Infanrix hexa and sudden death: a review of the periodic safety update reports submitted to the European Medicines Agency

There have been a number of spontaneous reports of sudden unexpected death soon after the administration of Infanrix hexa (combined diphtheria, tetanus, acellular pertussis, hepatitis B, inactivated poliomyelitis and Haemophilus influenza type B vaccine). The manufacturer, GlaxoSmithKline (GSK), submits confidential periodic safety update reports (PSURs) on Infanrix hexa to the European Medicines Agency (EMA). The latest is the PSUR 19. Each PSUR contains an analysis of observed/expected sudden deaths, which shows that the number of observed deaths soon after immunisation is lower than that expected by chance. This commentary focuses on that aspect of the PSUR which has a bearing on policy decisions. We analysed the data provided in the PSURs. It is apparent that the deaths acknowledged in the PSUR 16 were deleted from the PSUR 19. The number of observed deaths soon after vaccination among children older than one year was significantly higher than that expected by chance once the deleted deaths were restored and included in the analysis. The manufacturer must explain the figures that have been submitted to the regulatory authorities. The procedures undertaken by the EMA to evaluate the manufacturer’s claims in the PSUR need to be reviewed. The Drugs Controller General of India nearly automatically accepts drugs and vaccines approved by the EMA. There is a need to reappraise the reliance on due diligence by the EMA

Critical perspectives on the NIMH initiative “Grand Challenges to Global Mental Health”.

In July 2011 Nature carried a Comment titled “Grand Challenges to Global Mental Health”announcing research priorities to benefit people with mental illness around the world. The essay called for urgent action and investment. However, many professionals, academics, and service user advocate organisations were concerned about the assumptions embedded in the approaches advocated and the potential for the project to do more harm than good as a result. Nature refused to print a letter (sent on 20th August 2011) protesting against the issue, citing ‘lack of space’ as the reason. This letter is an effort to critique the initiative through wide participation and consensus