GlaxoSmithKline Fined Over Irregularities in Pediatric Vaccine Trials
A significant story about Big Pharma and vaccinations was quietly reported on the business pages this past week. Argentina’s National Administration of Medicine, Food and Medical Technology fined pharmaceutical giant GlaxoSmithKline and two doctors around $240,000 for irregularities in the recruitment of babies for bacterial pneumonia and meningitis vaccines.
Irregularities is Putting it Mildly
GlaxoSmithKline’s vaccine trials for bacterial pneumonia and meningitis took place in Argentina in 2007 and 2008 and gained significant media attention after 14 babies died during the trials. Although an investigation determined that none of the deaths were caused by the vaccine, the scrutiny that the company was put under as a result of them led to the discovery of several breaches of ethics and law.
GlaxoSmithKline recruited 15,000 babies under the age of one, mostly from economically disadvantaged families, for the Synflorix vaccine trials. The judge found that the consent forms were signed by parents who were illiterate or were signed by individuals who did not have legal custody of the child. Pediatrician Ana Marchese told FOREXPROS:
These doctors took advantage of many illiterate parents who take their children [to hospital] for treatment by pressuring and forcing them into signing these 28-page consent forms and getting them involved in the trials.
To make matters worse, when children experienced adverse reactions to the vaccines, worried parents were left in the dark. Dr. Marchese exlplained that “in various cases, the doctors who had conducted the trials did not answer the calls made by the worried parents after witnessing their babies’ reactions to the vaccines.”
GlaxoSmithKline Plans to Appeal
GlaxoSmithKline, however, told CNN that it “conducts clinical studies all over the world, respecting laws and meeting the highest standards of ethics and quality.” Rosana Felice, the medical director of Glaxo Argentina, told CNN that “none of the patients that were included in this study were included without their appropriate consent” and that the ruling is simply about the form or documentation, not about actual lacking consent.
With vaccine safety being questioned around the world, actions such as those of GlaxoSmithKline weaken the arguments made by Big Pharma. Testing of vaccines is critical, but when major lapses such as these are discovered, it puts the ethics and results of vaccination trials in question. GlaxoSmithKline needs to be more careful that it is dotting every ‘i’ and crossing every ‘t’.
Image credit: Ian Wilson on flickr