_GlaxoSmithKline has responded stridently to claims it behaved unethically by failing to get proper consent from the parents of children recruited for a clinical trial in Argentina of its pneumococcal vaccine Synflorix.
The drugs major has been fined 400,000 pesos (about $92,800) by Judge Marcelo Aguinsky following a report issued by the Argentinean National Administration of Medicine, Food and Technology (ANMAT). The judge found GSK responsible for “irregularities” in the recruitment of young children in 2007-8 and also fined two investigators about $70,000 each because consent forms were signed by illiterate parents or people who did not have custody of the children.
GSK says it "respectfully disagrees" with the ruling regarding the administrative conduct of the COMPAS study in Mendoza and will appeal. The firm says it conducts clinical trials "to the same high standards, irrespective of where in the world they are run" and "this includes the requirement to obtain informed consent from participants. That is a fundamental principle of our behaviour and any deviation from this is unacceptable".
With regards to COMPAS, GSK says it identified "some administrative irregularities in the process of obtaining informed consent from a small proportion of patients" and reported these findings to ANMAT. The company "immediately put in place a corrective action plan which involved reconfirming informed consent of patients in the study and retraining doctors conducting the study where necessary".
The safety of patients was not put at risk "and ANMAT agreed that the study could continue as planned", GSK says. COMPAS, which involved close to 24,000 children, was completed in Argentina in June 2011 and is now undergoing its closing phase.
Synflorix was licensed in Europe in March 2009 and in Argentina by ANMAT in August 2009 and remains available to help protect babies worldwide against pneumococcal diseases. More than 50 million doses of Synflorix have been distributed for use in children in over 100 countries.
No link to deaths and Synflorix
Much of the media coverage around the case has centred around the deaths of 14 babies and an allegation that a child participating in the study was refused treatment. GSK stressed thartr the fine does not relate to the deaths, saying that they have been "thoroughly and independently investigated, and it has been concluded by both the independent data monitoring committee and ANMAT that none of the deaths were related to the vaccine they were given".
Regarding the allegations that treatment was delayed for some children in the trial if they were unwell, GSK says "if true, these events are shocking…and we will be looking into this further".