- Argentina's drug administration has fined the company and two doctors nearly $240,000
- A medical group accuses GlaxoSmithKline of misleading trial participants
- The drug company denies those accusations and says it will appeal the fine
- GlaxoSmithKline says there were no irregularities regarding consent or the vaccine's safety
A medical group in Argentina is asking for more drug-testing regulations in the South American country after a officials fined pharmaceutical company GlaxoSmithKline for alleged irregularities in a pediatric pneumonia vaccine trial.
The Argentinian Federation of Health Professionals accuses drug maker GlaxoSmithKline of misleading participants and pressuring poor families into joining a trial for the Synflorix vaccine, which the company says protects against bacterial pneumonia and meningitis.
"They recruited children in an irregular manner. ... They did not do what they were supposed to. They did not inform. There were not independent witnesses. They pressured the mothers of poor children," said Jorge Yabkowsky, the federation's director.
But GlaxoSmithKline, the world's second largest pharmaceutical company, denies those accusations and says it will appeal a judge's approval of Argentina's National Administration of Medicine, Food and Medical Technology's fining the company and two doctors a total of nearly $240,000 for irregularities in documentation of the trial.
In a statement, GlaxoSmithKline said it conducts clinical studies all over the world, respecting laws and meeting the highest standards of ethics and quality.
"The ruling has to do with procedures, with the form of documenting procedures of the studies. ... None of the patients that were included in this study were included without their appropriate consent," said Rosana Felice, medical director of Glaxo Argentina.
Felice said official investigations by Argentina's drug administration, known as ANMAT, and ethics reviews have not turned up any irregularities in the vaccine's safety.
GlaxoSmithKline's statement said there are no cases alleging fraud or corruption in the study.
The deaths of 14 children who reportedly died after participating in the trials, have drawn widespread attention in Argentinian media. Their deaths are under investigation, but there has been no evidence linking deaths to the vaccine or irregularities in the studies.
Felice said GlaxoSmithKline categorically denies that the vaccine caused the deaths.
"In no case was it related to the administration of the vaccine, and this has been sufficiently demonstrated, proven and evaluated by ANMAT," Felice said.
But the health professional federation pointed to the children's deaths in its call for increased regulations on drug testing.
The trial included 24,000 children, Felice said, including 14,000 children in Argentina and 10,000 others in Colombia and Panama.
The Synflorix vaccine has been approved by regulatory agencies in more than 85 countries, based on more than 40 clinical studies, GlaxoSmithKline said.