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Program Information
 Bristol Broadband Co-operative 
 Liquorice Heaven: What is liquorice and how it is produced?
 Weekly Program
 Hope Hartley, Jon Coward
 Bristol Broadband Co-operative  
 For non-profit use only.
 Attribution No Derivatives (by-nd) 
 No Advisories - program content screened and verified.
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Infanrix hexa and sudden death: a review of the periodic safety update reports submitted to the European Medicines Agency.
Puliyel J, et al. Indian J Med Ethics. 2018 Jan-Mar.
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.

The specific taste of liquorice comes from liquorice root, which is a root from the liquorice branch, Glycyrrhiza glabra, and belongs to the butterfly flower. Liquorice branches are approx. 1 meter tall and their origins lie in countries around the Mediterranean, such as Greece, Spain, and Italy, or the so-called subtropical areas. The bushes grow best alongside a moist river bed. Liquorice root gets its sweet taste from glycerin. This acid is over fifty times sweeter than sugar. The after taste of glycerin is the typical liquorice taste. In the Netherlands, you can buy pieces of licorice root to chew on.

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