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GlaxoSmithKline Fined Over Irregularities in Pediatric Vaccine Trials

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’.

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Image credit: Ian Wilson on flickr

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11:08AM PDT on Apr 1, 2012

GlaxoSmithKline is just like Hitler, they need vulnerable disadvantaged people to experiment on. For CHRIST'S SAKES, you don't want them to use THEIR CHILDREN, DO YOU????

11:24PM PST on Jan 19, 2012

Definitely appears they were taking advantage of other countries to the point of causing deaths among the people. Just goes to show how useless animal testing is, because you know for sure that big pharma injured, maimed, tortured, and killed many, many animals in testing this drug before trying it out on the children of another country. Too bad the animals don't have voices to tell us their stories, otherwise this could have perhaps been avoided in Argentina.

4:13AM PST on Jan 19, 2012

Thanks for the article.

4:13AM PST on Jan 19, 2012


10:27AM PST on Jan 17, 2012

John D. I do have a degree in Biology. I have an open mind, and have researched this subject extensively.

10:15AM PST on Jan 15, 2012

these drugs start out being tested on animals and then the babies were brought in. When are people going to realise animal testing isn't safe?

1:27AM PST on Jan 14, 2012

About time.

6:26AM PST on Jan 12, 2012

Perhaps it is time that the CDC and FDA worked together with similar organizations around the world to prevent things like this from happening.

5:23AM PST on Jan 12, 2012

You do your best to keep your children healthy, but sickness and accidents are a part of life. Getting health insurance for your children gives you peace of mind knowing they have health coverage when they need it. Search one the web "Penny Medical" for kids they are the best.

12:54AM PST on Jan 12, 2012

To put it mildly, it would be a good idea to have greater oversight of drug companies and their activities.

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