Argentinean court upholds fines against GSK and two doctors for malpractice during vaccine trialBMJ 2012; 344 doi: https://doi.org/10.1136/bmj.e449 (Published 17 January 2012) Cite this as: BMJ 2012;344:e449
- Aser García Rada
An Argentinean court has dismissed an appeal by the drug company GlaxoSmithKline (GSK) and upheld a fine of 400 000 pesos (£61 000; €73 000; $93 000) for failing to properly monitor a trial of the multivalent pneumococcal conjugate vaccine Synflorix.
The judge has also upheld fines against two local doctors of 300 000 pesos each. Miguel Tregnaghi, the main coordinator of the trial in Argentina, was fined for failing to comply with good practice in the development of a clinical trial, and Hector Abate, the main investigator in Mendoza, one of the three regions where the study took place, was fined for administrative irregularities during patient selection and the collection of informed consent.
The penalty, the maximum that can be applied under national regulations for serious misconduct and the highest ever relating to clinical trials in the country, was imposed in 2009 by the Argentinean National Administration of Drugs, Food and Medical Technology (ANMAT) after detecting irregularities in the recruitment of …