Laboratory kills 14 babies in Argentina, get's fined 90.000 dollars

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zoukka

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http://en.mercopress.com/2012/01/04...menting-vaccines-in-babies-from-poor-families

GSK Argentina fined for experimenting vaccines in babies from poor families

GlaxoSmithKline Argentina Laboratories company was fined 400.000 Pesos (approx 90.000 dollars) by Judge Marcelo Aguinsky following a report issued by the National Administration of Medicine, Food and Technology (ANMAT) for the killing of 14 babies during illegal lab vaccine trials conducted between 2007 and 2008.

Likewise, two doctors, Héctor Abate, and Miguel Tregnaghi- were fined with 300.000 Pesos (approx 70.000 dollars) each for irregularities during the studies.

The charges included experimenting with human beings, falsifying parental authorizations so babies could participate in vaccine-trials conducted by the laboratory from 2007 to 2008.

Since 2007, 15.000 children under the age of one from Mendoza, San Juan and Santiago del Estero have been included in the research protocol, a statement of what the study is trying to achieve. Babies were recruited from poor families that attended to public hospitals.

A total of 7 babies died in Santiago del Estero; 5 in Mendoza; and 2 in San Juan.

Paediatrician Ana Marchese, who reported the case through the Argentine Federation of Health Professionals (FESPROSA), and was, working at the Eva Perón children's public hospital in Santiago del Estero when the studies were being conducted, said in a radio interview that “GSK Argentina set a protocol at the hospital, and recruited several doctors working there.”

“These doctors took advantage of 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.”

“Laboratories can't experiment in Europe or the United States, so they come to do it in third-world countries.“

Colombian and Panama were also chosen by GSK as staging grounds for trials of the vaccine against the pneumococcal bacteria.

Likewise, Marchese, explained the modus operandi: “Once a picked patient arrived, it would automatically disappear to be taken somewhere else in order to be treated by those doctors specially recruited by GSK. These kinds of practices are not legal and occurred without any type of state control, plus they don’t comply with minimum ethical requirements.”

Marchese also remembered that “laboratory trials on human beings are not legalized in Argentina.”

Furthermore, the pediatrician explained that “it is also known that in various particular 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.”

According to Marchese, “there already exist very good vaccines for the same diseases, but we all know how laboratories work, they only care for their own business.”

To end, Doctor Marchese aimed to Santiago del Estero Governor, Gerardo Zamora, who “never ever came out to stage to comment on the case, and same happened with national deputies and senators that didn’t even bother into discussing a hot topic that was echoed worldwide. I’m also ashamed of the scientific community that also kept its mouth shut.”

GlaxoSmithKline is a global pharmaceutical, biologics, vaccines and consumer healthcare company headquartered in London, United Kingdom. It is the world's third-largest pharmaceutical company measured by revenues after Johnson & Johnson and Pfizer.

Ironically, if one visits GlaxoSmithKline Argentina web site it welcomes the reader with a company disclosure that says: “We have a challenging and inspiring mission to improve the quality of human life by enabling people to do more, feel better and live longer.”
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This is some sinister, goebbels level of evil happening there. How the doctors and their superiors are still free and kicking is beyond my comprehension. Any Argentinians here? How's the legal system there?
 
Wow, seriously fucked up. They really need to improve their controls on experimentation in these countries. Glad shit like this is very unlikely to happen in the western world but with these being western companies, we should all feel a bit ashamed.

Also: Way to improve your reputation Big Pharma.
 
Maleficence said:
Wow, seriously fucked up. They really need to improve their controls on experimentation in these countries. Glad shit like this is very unlikely to happen in the western world but with these being western companies, we should all feel a bit ashamed.

Also: Way to improve your reputation Big Pharma.
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It's our responsibility to keep our companies in check. What can these poor, corrupted areas do to combat this?
 
All those companies are evil.

Maleficence said:
Wow, seriously fucked up. They really need to improve their controls on experimentation in these countries. Glad shit like this is very unlikely to happen in the western world but with these being western companies, we should all feel a bit ashamed.

Also: Way to improve your reputation Big Pharma.
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Are you aware of the experiments conducted by the USA in Guatemala in the end of the last century?
 
zoukka said:
It's our responsibility to keep our companies in check. What can these poor, corrupted areas do to combat this?
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No. It isn't our responsibility to protect ourselves. It's the responsibility of local governments. In western countries we have protections from these things, either these protections aren't in place in Argentina or they're enforced poorly. Either way the Argentinian government needs to protect it's people.
 
Fuck I found out the same experiments have been taking place here in Finland. And this is supposed to be a fucking safe haven against shit like this.
 
wow...do you think those that got hit with the fine laughed to themselves about it? seriously messed up...
 
Maleficence said:
No. It isn't our responsibility to protect ourselves. It's the responsibility of local governments. In western countries we have protections from these things, either these protections aren't in place in Argentina or they're enforced poorly. Either way the Argentinian government needs to protect it's people.
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Enforced poorly. Cash rules everything in Argentina. Extreme corruption and a tendency to look the other way for the right dollar amount. I love Argentina but it seems like every single person in a position of power there is a self serving piece of shit who does nothing unless it makes them richer or more powerful. I'm sure that harpy Christina will find a way to turn this into some kind of approval ratings booster for her as she loves to use the poor and less educated to make herself look popular. A few angry remarks about protecting the underprivileged and presto the people she has repeatedly jerked around love her again/more.
 
Call me a despicable corporate apologist, but I get the feeling we may not be getting the whole story. The allegations sound pretty bad, but there's still a lot we don't know.

Also, if Argentina doesn't allow "human experimentation," how can any Argentinian company develop new drugs? Human trials are always needed at some stage in development.
 
Orayn said:
Call me a despicable corporate apologist, but I get the feeling we may not be getting the whole story. The allegations sound pretty bad, but there's still a lot we don't know.

Also, if Argentina doesn't allow "human experimentation," how can any Argentinian company develop new drugs? Human trials are always needed at some stage in development.
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Oftentimes, trials relating to investigating the toxicity of products for humans amount to nothing more than testing on rats.
 
Not surprised. Considering how popular Argentina was with escaped Nazi's, it only figures a little of that Nazi blood got in the water*










*
/half-serious
 
Besides the tragic death of 14 babies, I'm furious at scientists like this because this story will only add fuel to the fire of the "big pharma vaccine scandals," and who's to say how many other babies will die due to ignorant parents refusing vaccinations.
 
Orayn said:
Call me a despicable corporate apologist, but I get the feeling we may not be getting the whole story. The allegations sound pretty bad, but there's still a lot we don't know.
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I would love to see how someone spins "experimenting on babies" in a non-evil light.

Like a previous poster implied, that is some Mengele-level shit right there.
 
Risible said:
I would love to see how someone spins "experimenting on babies" in a non-evil light.

Like a previous poster implied, that is some Mengele-level shit right there.
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Never forget, GAF has a defense force for everything. As for this news I'll love to say I'm surprised but sadly I'm not.
 
What a poorly written article. No mention of the clinical trial stage. No mention of the type of vaccine being developed. No mention of the results of earlier clinical trials. No mention of how these 14 babies out of 15,000 died or proof that it was caused by the vaccine. Also, the person being quoted is either an idiot or something was lost in the translation.
“Laboratories can't experiment in Europe or the United States, so they come to do it in third-world countries.“ What the fuck does that even mean? There are thousands of human clinical trials (experiments) being conducted every single day in the U.S.
“laboratory trials on human beings are not legalized in Argentina.” Really? Human clinical trials are illegal there? Anyone from Argentina here that can confirm this? And nobody bothered to tell GSK before they set up shop there... and nobody stopped them? Sorry, but I'm not buying it.
“there already exist very good vaccines for the same diseases" Wtf? There are vaccines against these bacteria but they don't cover all of the almost 100 subtypes. Is this person for real? They are spending millions/billions to develop a vaccine against the same subtypes? I'm not buying it.
It sounds like these doctors were going about it in a shady way and that's fucked up. If true, they should be rotting in jail. But, I have no idea what to believe after reading this article.
 
Man, you'd like to think shit like this isn't happening in the world but it gives me chills just thinking about human testing like this
 
Bulbo Urethral Baggins said:
What a poorly written article. No mention of the clinical trial stage. No mention of the type of vaccine being developed. No mention of the results of earlier clinical trials. No mention of how these 14 babies out of 15,000 died or proof that it was caused by the vaccine. Also, the person being quoted is either an idiot or something was lost in the translation.
“Laboratories can't experiment in Europe or the United States, so they come to do it in third-world countries.“ What the fuck does that even mean? There are thousands of human clinical trials (experiments) being conducted every single day in the U.S.
“laboratory trials on human beings are not legalized in Argentina.” Really? Human clinical trials are illegal there? Anyone from Argentina here that can confirm this? And nobody bothered to tell GSK before they set up shop there... and nobody stopped them? Sorry, but I'm not buying it.
“there already exist very good vaccines for the same diseases" Wtf? There are vaccines against these bacteria but they don't cover all of the almost 100 subtypes. Is this person for real? They are spending millions/billions to develop a vaccine against the same subtypes? I'm not buying it.
It sounds like these doctors were going about it in a shady way and that's fucked up. If true, they should be rotting in jail. But, I have no idea what to believe after reading this article.
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This is a sound analysis of the article, it is highly unlikely that clinical trials are illegal in Argentina as their ANMAT regulatory body regularly approves them and subsequently approved this exact trial.

Here is another article on the issue.

http://www.inpharm.com/news/170700/gsk-faces-fine-over-argentina-clinical-trial

GSK has been at pains to point out that the fine was never about the safety of the vaccine, which was licensed in Argentina in 2009
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The pharma company said it offered its “full sympathy to their families” but added that “any deaths in the study have been thoroughly and independently investigated, and it has been concluded that none of the deaths were related to the vaccine they were given”.
ANMAT has accepted there was no link between the administration of Synflorix and the deaths - however, GSK admits that it was at fault over the way recruitment for the trial was carried out.
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The fine was not related to the deaths of 14 babies out of the 15,000 in the trial, it was to do with the abuse of power of the Doctors and how GSK SOP allowed them to do this.

The vaccine Synflorix is a competitor product against Pfizer's Prevnar and was supposed to cover prevention of different serotypes of pnuemococcal disease common in different regions that Pfizers product didn't cover, it's been licensed for 2 years and is now in regular use worldwide in childhood immunisation schemes.
 
Bulbo Urethral Baggins said:
What a poorly written article. No mention of the clinical trial stage. No mention of the type of vaccine being developed. No mention of the results of earlier clinical trials. No mention of how these 14 babies out of 15,000 died or proof that it was caused by the vaccine. Also, the person being quoted is either an idiot or something was lost in the translation.
“Laboratories can't experiment in Europe or the United States, so they come to do it in third-world countries.“ What the fuck does that even mean? There are thousands of human clinical trials (experiments) being conducted every single day in the U.S.
“laboratory trials on human beings are not legalized in Argentina.” Really? Human clinical trials are illegal there? Anyone from Argentina here that can confirm this? And nobody bothered to tell GSK before they set up shop there... and nobody stopped them? Sorry, but I'm not buying it.
“there already exist very good vaccines for the same diseases" Wtf? There are vaccines against these bacteria but they don't cover all of the almost 100 subtypes. Is this person for real? They are spending millions/billions to develop a vaccine against the same subtypes? I'm not buying it.
It sounds like these doctors were going about it in a shady way and that's fucked up. If true, they should be rotting in jail. But, I have no idea what to believe after reading this article.
Click to expand...


Apparently it's this or a variant of it:

Synflorix, PhiD-CV, Streptorix, GSK1024850A, GSK1024850
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I read about it and the same company does the trials in my country and has been constantly reminded about the ethical side of the trials. The national vaccine-info recommends not to take part in the trials because of missing research and documents that are being kept secret despite the government wanting them public.

Also the company is paying for the nurses a fee for each child that they can successfully enlist, a tradition that is forbidden by law in here...

http://www.rokotusinfo.fi/rokotetutkimus/#pnc (all in finnish unfortunately)
 
Maleficence said:
Wow, seriously fucked up. They really need to improve their controls on experimentation in these countries. Glad shit like this is very unlikely to happen in the western world but with these being western companies, we should all feel a bit ashamed.
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The right is still pushing hard for deregulation. Libertarians too. They want this in the US, and they want it bad.
 
Freshmaker said:
The right is still pushing hard for deregulation. Libertarians too. They want this in the US, and they want it bad.
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Want what exactly? Trials like this in children are regular in the US and the rest of the developed world as well, even those outside of the USA are regulated under the same FDA rules, otherwise they can't license the product.
 
So the fine was for unethical recruitment methods only? There's no definitive proof that the vaccine itself caused the death of the babies?
 
Al-ibn Kermit said:
So the fine was for unethical recruitment methods only? There's no definitive proof that the vaccine itself caused the death of the babies?
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Yes, in a certain area in particular these two doctors acted in an unethical or incorrect manner to recruit a small number of patients.

The vaccine is even in regular use in the UK and the rest of Europe now. The deaths were investigated and ANMAT was given the required information and ANMAT agreed that the vaccine was not linked to the 14 deaths out of the 15000 participants in Argentina.

Also just found this:

http://www.washingtonpost.com/busin...dy-of-babies/2012/01/03/gIQANByzYP_story.html

Argentina’s drug regulator, ANMAT, said in a statement Tuesday that “all of these patients had been given a placebo — that’s to say, something that appeared to be the vaccine but that had no active ingredients. The vaccine is safe."
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I would expect to see a greater amount of deaths if there was something in the excipients that could cause this, if they even used an excipient mixture, it may have just been a saline placebo or even an altogether different vaccination by a different company, whichever it is I can't reasonably see that the deaths could have been caused by synflorix.
 
GJS said:
Yes, in a certain area in particular these two doctors acted in an unethical or incorrect manner to recruit a small number of patients.

The vaccine is even in regular use in the UK and the rest of Europe now. The deaths were investigated and ANMAT was given the required information and ANMAT agreed that the vaccine was not linked to the 14 deaths out of the 15000 participants in Argentina.

Also just found this:

http://www.washingtonpost.com/busin...dy-of-babies/2012/01/03/gIQANByzYP_story.html


I would expect to see a greater amount of deaths if there was something in the excipients that could cause this, if they even used an excipient mixture, it may have just been a saline placebo or even an altogether different vaccination by a different company, whichever it is I can't reasonably see that the deaths could have been caused by synflorix.
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So basically the story is false and is simple a ruse to draw up page views? Gotta love "journalism"
 
GJS said:
Want what exactly? Trials like this in children are regular in the US and the rest of the developed world as well, even those outside of the USA are regulated under the same FDA rules, otherwise they can't license the product.
Click to expand...

Get rid of the FDA, and then they won't have to fudge permissions in a third world country.
 
GJS said:
Yes, in a certain area in particular these two doctors acted in an unethical or incorrect manner to recruit a small number of patients.

The vaccine is even in regular use in the UK and the rest of Europe now. The deaths were investigated and ANMAT was given the required information and ANMAT agreed that the vaccine was not linked to the 14 deaths out of the 15000 participants in Argentina.

Also just found this:

http://www.washingtonpost.com/busin...dy-of-babies/2012/01/03/gIQANByzYP_story.html

Argentina’s drug regulator, ANMAT, said in a statement Tuesday that “all of these patients had been given a placebo — that’s to say, something that appeared to be the vaccine but that had no active ingredients. The vaccine is safe."
Click to expand...

I would expect to see a greater amount of deaths if there was something in the excipients that could cause this, if they even used an excipient mixture, it may have just been a saline placebo or even an altogether different vaccination by a different company, whichever it is I can't reasonably see that the deaths could have been caused by synflorix.
Click to expand...

The thick plottens. I knew there had to be more to this story than EVIL PHARMA GIANT KILLS BABIES AND FEELS NO REMORSE!
 
Just out of curiousity, who here has a problem with the idea of human trials for drugs? The impression I get here, is that some people read "human experimentation" and failed to understand that is simply another term for human trials, an accepted and necessary aspect of drug development, not just by corporations, but also public research. The only reason "human experimentation" gets people going, is because it evokes images of nazi experimentation, which was horrid as a consequence of the experiments holding no scientific value whatsoever. This is of course very different than the testing of a vaccine, something which does hold scientific value.

So again, who here has a problem with the "human experimentation"?

Edit: It appears Orayn's level headed approach to news sensationalism was the correct one. Please take note people.
 
Earthstrike said:
Just out of curiousity, who here has a problem with the idea of human trials for drugs? The impression I get here, is that some people read "human experimentation" and failed to understand that is simply another term for human trials, an accepted and necessary aspect of drug development, not just by corporations, but also public research. The only reason "human experimentation" gets people going, is because it evokes images of nazi experimentation, which was horrid as a consequence of the experiments holding no scientific value whatsoever. This is of course very different than the testing of a vaccine, something which does hold scientific value.

So again, who here has a problem with the "human experimentation"?

Edit: It appears Orayn's level headed approach to news sensationalism was the correct one. Please take note people.
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Children can't consent.

No problem with adults doing it.
 
Disgusting.

As a father, this literally makes my blood boil. Poor, innocent babies. These people should be executed slowly and painfully.
 
Count Dookkake said:
Children can't consent.

No problem with adults doing it.
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It's a difficult situation, however children are not mini-adults and due to this drug pharmacokinetics can be vastly different.

Essentially because of a lack of child based clinical trials in the past we have left all treatment decisions to paediatricians to come up with and figure out, based on what happens when they give children medications untested.

So almost every treatment for a child in part becomes an experiment or clinical trial in itself, as we are not sure what is going to happen and it makes paediatrics a much more challenging area. Of course standardised treatment doses and regimens have been decided now for many medications based upon this process but it seems to me to be a particularly dangerous and risky process in this day and age.

Clinical trials in children are becoming more common and the rule of 7 is commonly used to decide consent/assent of the child itself, if a child who is over 7 does not want to take part in the trial then they don't take part. Unless it was in a situation whereby the child was in some sort of increased risk of mortality by declining the trial and the parents wanted the child to go ahead with it, which may at some point be the case with rare conditions where there are only a handful of sufferers in the world.

The use of clinical trials allows us to figure out working and safe doses for children in a controlled and safe environment with a team of people specifically working with that drug and disease state, so if something goes wrong it can safely be resolved without causing harm. It should essentially remove a majority of cases of medications being given to children at experimental doses and a hospital paediatrician not being ready to deal with something going wrong and not knowing what to do, making treatment safer as they would instead be using already tested and safe ranges.

Of course this is different to cases such as vaccine clinical trials but the negatives in regards to that are completely different and in some cases unfounded. A lot of the fears surrounding anti-vaccination are illogical and don't stand up to the facts, so the benefit of a vaccination that could save a child's life usually far out ways the risk.

In combination with this it is also a reasonably common practice to give these children in developing countries other vaccinations such as to protect from things such as Hep B and MMR, so that even if the trial vaccine has no significant immunological effect in the child they still receive protection from things they may not have received or could not afford before.

As I said it is a difficult area, ethically and morally, but 'first do no harm' should always be the first thought, and in the vast majority of cases a drug would not make it to human trials if it was significantly likely to cause harm in humans. So the risk of something we did not expect to happen may be outweighed by the higher chance that this would do some good once it has reached this stage 10 years down the line.
 
Sadly having worked in big pharma and the clinical trials it was only a matter of time until this happened. And it'll only be a matter of time until it happens again.
 
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