14 babies in Argentina died after being part of vaccine trials conducted by GlaxoSmithKline.
In 2012, for example, an Argentinean judge found the company guilty of conducting illegal vaccine trials.
The company was found guilty of conducting trials on human beings (which is prohibited in Argentina) and of falsifying parental authorizations allowing the company to experiment on babies.
The judge handed down the ruling following a report by the National Administration of Medicine, Food and Technology (ANMAT) which concluded that the COMPASS trial conducted between 2007 and 2008 demonstrated “failures in the process of obtaining the necessary consent letters from participants, hence violating the patients’ rights; as well the inclusion of patients that did not fully meet the required clinical conditions to be submitted into the program.”
A total of 15,000 children under the age of one were recruited into the study from poor families attending public hospitals in three separate Argentinean provinces.
The scandal was broken by pediatrician Ana Marchese, who learned of the COMPASS study while working at one of the public hospitals involved. She reported the violations to the Argentine Federation of Health Professionals (FESPROSA), which later took the complaints to the government.
“GSK Argentina set a protocol at the hospital, and recruited several doctors working there,” Marchese said. “These doctors took advantage of the many illiterate parents whom take their children for treatment by pressuring and forcing them into signing these 28-page consent forms and getting them involved in the trials.”
“[Drug companies] can’t experiment in Europe or the United States, so they come to do it in third-world countries,” she said.
The COMPASS trial was conducted to test a new pneumococcal vaccine. Similar trials were conducted in Colombia and Panama.
Marchese noted that the new vaccine is not significantly different from existing pneumococcal vaccines.