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GlaxoSmithKline loses appeal in Argentinean Court for malpractice during paediatric vaccine trial

Fine against British drugs company upheld after drugs trial

Posted on 26 January 2012

The BMJ has reported that Argentina’s Economic Crime Court has rejected the appeal of the UK drugs company GlaxoSmithKline (GSK) and upheld the fine of 400,000.00 pesos, equivalent to £61,000, imposed by the Argentinean National Administration of Drugs Food and Medical Technology (ANMAT) in 2009 for failing to properly monitor a trial of the vaccine Synflorix. 

This penalty represented the maximum penalty available to ANMAT for serious misconduct and is the highest ever in respect of clinical trials.

The Judge also upheld two fines of 300,000 pesos against two local doctors, Miguel Tregnaghi and Hector Abate in relation to their actions as to how the clinical trial was carried out.

Synflorix is a paediatric pneumococcal vaccine to protect against Streptococcus pneumoniae, which causes diseases such as meningitis and bacteraemic pneumonia, as well as middle ear infections. The trial itself, known as the Clinical Otitis Media & Pneumonia Study or COMPAS, was undertaken in Argentina, Panama and Chile, whose population are deemed at high risk of contracting Streptococcus pneumoniae.  Healthy children, aged between 6 and 16 weeks were recruited.

The BMJ reported that there were 14 deaths among the 14,000 babies enrolled in the Argentinian arm of the study, but that GSK and ANMAT say that the vaccine was not responsible.

However, irregularities concerning the consent procedure and recruitment process were detected by GSK and ANMAT in 2007 and 2008, when a number of parents of the infants involved were found not to understand the scientific terms used when gaining their consent.  Anecdotal evidence was also reported in the Argentinian press of illiterate parents being provided with no explanation of the trial’s consent documentation and reports of study doctors failing to answer calls from worried parents whose babies had experienced a negative reaction to the vaccine.

Both GSK and the doctors involved are appealing the decision.