Pharmaceutical giant to file appeal in apex court
A lower court in Argentina has fined GlaxoSmithKline (GSK) US $92,786 for conducting unethical clinical trials of a pneumonia vaccine on 15,000 babies in the country. It is reported that most of the infants recruited for the trial were from poor families who attended public hospitals. However GSK, Britain’s biggest pharmaceutical company, has denied charges and will soon file an appeal against the ruling in the Supreme Court of Argentina.
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The lower court ruling in the first week of January was based on a recent report by the National Administration of Medicine, Food and technology (ANMAT), a government agency that monitors public health. It found irregularities in the trial of Synflorix vaccine conducted between 2007 and 2008. The vaccine manufactured to fight pneumococcal diseases has allegedly killed 14 babies in the country during the trial period. The vaccine was given license in March 2009 for marketing in Europe.
The court also fined two doctors with US $69,589 each for irregularities during the trials.
A press communiqué released by ANMAT shows that the irregularities detected during the trial were related to failures in obtaining the informed consent for participation from parents, hence violating patients’ rights, and inclusion of patients that did not fully meet the required clinical conditions.
It is reported that the trial investigators did not take proper consent from the children’s parents before injecting them with Synflorix. In some cases, scientists working for GSK relied on permission from under-age parents or illiterate grandparents. The investigators also did not have adequate records of the children’s ages, medical histories and previous vaccines given to the babies.
A total 24,000 babies were recruited for the vaccines trials 15,000 in Argentina, and, 9000 in Columbia and Panama. Doctors working at the Eva Peron children’s public hospital in Santiago del Estero, a province in Northern Argentina where trials were being conducted have reportedly said that doctors sometimes even pressurised the parents to sign the consent form. Many doctors did not even receive the calls made by the worried parents who witnessed vaccine reactions in their babies, reported Buenos Aires Herald, a national newspaper.
However, GSK has ‘respectfully’ disagreed with the charges in a press statement released by it on January 11. It says none of the 14 deaths are related to the vaccine. Besides, the court charges relates to the administrative procedures in place between 2007 and 2008 and not to the safety of the vaccine. “The irregularities were corrected whenever they were reported to us. GSK conducts clinical trials to the same high standards, irrespective of where in the world they are run. This includes the requirement to obtain informed consent from participants,” the press release said.
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