By Forexpros.comPharmaceutical giants GlaxoSmithKline Argentina Laboratories is to appeal against a fine for "irregularities" during clinical drug trials involving babies.
The 400,000 pesos (£60,000) fine was issued by a Buenos Aires court after a report by the National Administration of Medicine, Food and Tech-nology (ANMAT), which accused the drug maker of experimenting with humans and falsifying parental authorisation documents so that babies could be part of the vaccine trials conducted by the laboratory between 2007 and 2008.
The trials gained attention in Argentina after the Buenos Aires Herald reported that during the studies 14 babies died. They had taken part in trials on the Synflorix vaccine, which the company says protects against bacterial pneumonia and meningitis.
GSK Argentina medical director Rosana Felice categorically denied that the vaccine was responsible for the deaths.
"Any deaths in the study have been thoroughly and independently investigated and it has been concluded that none of the deaths were related to the vaccine they were given," she said.
"In no case was it related to the administration of the vaccine and this has been sufficiently demonstrated, proven and evaluated by ANMAT."
Since 2007, 15,000 babies under the age of one were recruited for the GlaxoSmithKline trials. Many of the babies came from... Read Full Article
