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Glaxo Smith Kline is testing a pneumonia vaccine in Argentina. Twelve Argentinian children have died. The clinical trial continues, because everyone knows, a trial isn't a failure until at least two dozen children are dead. Six dozen if they are from poor families who have no recourse and desperately need the money paid for participation. From one of the GSK investigators:
"Only 12 have died throughout the country, which is a very low figure if we compare it with the deaths produced by respiratory illnesses caused by the pneumococcal bacteria," pediatrician Enrique Smith, one of the lead investigators, said.
In Santiago del Estero, one of the country's poorest provinces, the trials were authorized when Enrique's brother, Juan Carlos Smith, was provincial health minister.
According to pediatrician Ana Maria Marchese, who works at the children's hospital in the provincial capital where the studies are being conducted, "because they can't experiment in Europe or the United States, they come to do it in third-world countries."
Read the full article HERE.
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I am proud of the progress done in my country regarding research and I have been involved in clinical research in Argentina for 10 years now.
It is easy to criticize without having the right elements.
The data released for the study was of excellent quality.
If Informed consent content was not communicated appropiately maybe this should be analized by the justice based on evidence.
Argentina has complied with GCP for 10 years now (enforced by Regulation 5330/97) and many regulations and onstructions rule in the ountry regarding research.
In addition Inspections are increasing.
Please do not think you can judge a country you have never visited or you can know a culture you have never been familiar with.
Clinical research arises media noise worldwide but when it cuts down to the facts little is there to say and much is ignored to convince the reader of a biased point of view.
Do you know that children were autopsied?
Did you know that no realitoon was proved between deahs and study or vaccine
Anne Blanchard, CCRA
www.blanchardyasociados.com.ar
www.ceciliagrierson.org
Posted by: Anne Blanchard | November 29, 2008 at 08:15 PM
There was an AP article on the topic. See http://www.msnbc.msn.com/id/26219689/
The article quotes Glaxo spokeswoman. She said:
The natural infant death rate in those countries from pneumonia is 4 to 5 of every 1,000 live births — more than four times the rate seen in the study.
She was lying. This number: 4 to 5 of every 1000 live births is pure fiction. There real number is in the Unicef report on pneumonia quoted earlier in this blog. There is a table on page 34. We see that in 2004 child mortality rate in Argentina was 18 per 1000 live births, and 3% of that was attributable to pneumonia. The product is 0.54. Even with all possible roundings (if 3 was rounded from 3.5 and 18 was rounder from 18.5) it is no higher than 0.64, nothing remotely as high as 4 to 5.
And this lie is now spread far and wide.
Posted by: anonymous | August 25, 2008 at 12:10 AM
"In an attempt to reduce the carnage, the traffic department installed a stop sign, and in the first twelve months following its installation, 10,000 people passed through that intersection but only 12 of them died in accidents."
The logic that reduced deaths are directly tied to the introduction of the *stop sign* and therefore proof that the stop sign *works* (reduces deaths) is presumptuous when in all actuality it could be that *bad drivers* decided to use a different route, moved out of the area, or more good drivers moved into the area, and the list goes on.
Exhibit one of what I call *twisting* the science or using-epi-to-get-the-results-that-you-want-without-ever-interviewing-the-drivers-in-the-car-to-get-the-full-story science.
Posted by: Kelli Ann Davis | July 20, 2008 at 12:27 PM
Perhaps I misunderstood you. While I agree that Tsu Do Nimh's pseudonym is mildly amusing, I thought that you were indicating that Sue Doe Nim(Rod's) rather off-base post was the "one of the funniest comments" that you'd ever read. On that basis, I disagreed with you, for this reason:
If you take this out of the emotionally-charged arena of vaccine testing and look at it from a more neutral perspective, you might imagine that your local traffic department estimated that each year for the past ten years about 10,000 people passed though a particular intersection near your home, and each year for the past ten years, on average, 80 of them died in collisions at that crossroads. In an attempt to reduce the carnage, the traffic department installed a stop sign, and in the first twelve months following its installation, 10,000 people passed through that intersection but only 12 of them died in accidents. If your first reaction to that information would be to demand the removal of the stop sign because 12 people had died since its installation, I don't think it would be funny, but most people, whether or not they are science buffs, would find it hard to understand.
That's not "twisting the science". That's the science.
Posted by: brian | July 20, 2008 at 12:02 AM
Nigeria Issues Arrest Warrants for Top Pfizer Officials After Drug Experiments Conducted on Children
http://www.naturalnews.com/023654.html
Posted by: Julie R. | July 18, 2008 at 02:43 PM
Brian:
What's *funny* is this orignial comment from Tsu Dho Nihm which is a classic *nice try* attempt at twisting the science:
"I prefer to look at the 68 babies whose expected deaths didn't happen because of the vaccine."
And then this rebuttal comment from Sue Doe Nim(rod):
"Cute name, dude. Your point is very "epidemiological." Yes, X number of children may have died from pneumonia. But your child may not have been one of them. It's like when people say, 1 in X women will get breast cancer - look to your left and to your right and one of them.... That's based on stats. No one in the room may ever get breast cancer."
The explanation, combined with the *handle name* was classic and right on target.
There. Does that help ya out any in the I'm-totally-confused-on-why-this-is-funny-department?
Posted by: Kelli Ann Davis | July 17, 2008 at 08:50 PM
No, I don't have any information on the trial other than what's available at this site (including Tsu Do Nimh's translation of the Argentine newspaper article) and the listing I found today at clinicaltrials.gov, plus I did a quick check of child mortality rates for various countries. The translated article specifically indicated that far fewer deaths (12) were recorded in the study group than would have been expected (80) for the number of children enrolled in that province. That didn't seem funny to me.
Posted by: brian | July 17, 2008 at 07:38 PM
So Brian, you seem to know an awful lot about this trial.
What is your source? You appear to have clinical trial data that hasn't yet been published.
How do you know this death rate is below expected rates? Obviously the news article considered these 12 deaths news and they wouldn't be news if they were unrelated to the vaccine.
Why do you not respond to the concerns of a local group that the trial has ethics problems? The phenomenon of testing vaccines overseas for high income markets is a sleazy practice that you don't bother to address.
Who are you? This comment makes you sound like a pharma marketer. We welcome rational discussion here but we also require transparency, especially for participants who jump in, in your words, without context..
Posted by: Mark | July 17, 2008 at 04:32 PM
I'm sorry, but I missed the joke. I think that Tsu Do Nimh (!) was trying to point out that there's really no reason to suspect that the reported deaths are "collateral damage" from the study, but that they would likely have occurred even if the children had not been on study; in fact, the death rate in the study group is much lower than would be expected for an equivalent group of children who did not receive vaccine.
Some of you may be interested in this UNICEF report on pneumonia: http://www.childinfo.org/files/Pneumonia_The_Forgotten_Killer_of_Children.pdf
Even in countries with with adequate health services resources and with penicillin and other comparably effective antibiotics, the overall case-fatality rate for pneumococcal pneumonia is around 5% to 15%, and of course it's higher in much of the world and in sensitive population such as children under five and the elderly. Resistance to common antibiotics is increasingly frequent among the pneumococci, so culture and sensitivity analysis is recommended to ensure that an appropriate antibotic is selected--but that necessary service is unavailable to most children: The UNICEF report indicates that only about 20% of children with pneumonia receive any antibiotics at all. That's why UNICEF and WHO, among other organizations concerned with the health of children, suggest that a single injection may be a more promising way of saving some of those 600,000 to one million lives than trying to find effective emergency therapy once a child contracts a life-threatening disease.
Posted by: brian | July 17, 2008 at 02:42 PM
For Sue Doe Nim(rod):
Okay, this is hands-down one of the funniest comments I've ever read!
I am literally laughing my butt off and I was thinking the same thing, but not being the *science buff* didn't know exactly how to articulate it!
THANKS for the laugh and for saying what I was thinking!
Posted by: Kelli Ann Davis | July 16, 2008 at 08:22 PM
Cute name, dude. Your point is very "epidemiological." Yes, X number of children may have died from pneumonia. But your child may not have been one of them. It's like when people say, 1 in X women will get breast cancer - look to your left and to your right and one of them.... That's based on stats. No one in the room may ever get breast cancer.
Posted by: For Sue Doe Nim(rod) | July 16, 2008 at 06:30 PM
Let me follow up on Tsu Do Nimh's post. It's always interesting to consider information in context. Here's the context:
1. The clinical trial is intended to test the efficacy of a new vaccine against pneumococcus, the major bacterial cause of childhood pneumonia.
2. About two million children under five years of age die of pneumonia each year.
3. About one-third to one-half of these deaths are attributable to pneumococcal pneumonia--or roughly 600,000 to one million deaths.
4. Pneumococcal pneumonia can be prevented by vaccination.
Here's some more context:
5. While this number may not be the correct figure for the study population, in Argentina the death rate of children under five years of age is approximately 18 per thousand.
6. The trial is designed to enroll 24,000 infants.
7. Some of those 24,000 children will die. Perhaps some vaccinated children will die of pneumococcal pneumonia (although likely fewer than would have died from that cause had they not been vaccinated), but some children will die of other causes, whether or not they happen to be enrolled in a vaccine trial.
8. Not all of the children in the study receive the new vaccine: in this double-blind study, some of the children receive a different, already-approved vaccine.
9. At this point, it is impossible to know whether the deaths on study are in any way related to receiving the study drug.
Posted by: brian | July 16, 2008 at 05:57 PM
I found some information for you in an Argantine newspaper: "En un año, de acuerdo a la cantidad de gente que ingresó al estudio y a las tasas de mortalidad, lo esperable es que se produjeran 80 muertes, sin embargo se han producido 12. Quiere decir que la tasa de mortalidad es más baja de lo esperado”
What he is saying is that in a group of infants the size of the group that was enrolled in the study for that province, at the current mortality rate in that province, there would be 80 deaths expected (from all causes) among the group, and they only had 12 deaths. The deaths were just deaths from all causes, not deaths specifically due to the vaccine.
I prefer to look at the 68 babies whose expected deaths didn't happen because of the vaccine.
And yes, I read Spanish, I do not need to use Babelfish.
Posted by: Tsu Dho Nimh | July 15, 2008 at 11:36 PM
Hi everyone,
Thank you for supporting this petition. I felt I had to do something to stop the madness. If you want to help with it, please copy and paste the link, and post on all groups, and forward to all supporters. Do you think it will help, or will they just turn a blind eye again? I will gladly hand it to JB when I feel we have enough signatures. Maybe he can guide me on how and where to present it. If we had an earth shattering number of signatures, it would be harder to ignore. Thanks for all the hard work here at AoA!!!
Julie
Posted by: Julie | July 15, 2008 at 08:08 AM
A few more signatures on that petition wouldn't hurt. . .right now, it's at 99 (and counting).
Posted by: Terri Lewis | July 14, 2008 at 11:05 PM
Check out AHRP's site in a few days, they'll post their re-review of the article. As of a day ago, this blogger was unable to find this news from any source other than this trade publication: http://www.ahrp.org
My husband is from Argentina. There's a serious history of human rights abuses in the country with a particular flare about thirty years back when more than thirty thousand unionists, academics and others were murdered by the government, many of their children stolen and secretly adopted by members of the military elite. Back then, the military junta was responsible. These days, it's a "junta medica" stealing children-- only these kids aren't living some semblance of a normal life elsewhere or, in some cases, living at all.
Perhaps especially since the Argentine economy collapsed around 2000-2001, it seems that human life is once again for sale, along with science and medicine. It's becoming too much like the US in terms of corporate influence. One of the worst examples is the Pichichero thimerosal study performed in an Argentine hospital. One resident of Buenos Aires described this study as corrupt idiocy. She also described the current vaccine injury crisis in Argentina as worse than the death squads of the 70's: it appears that up to 250K children may have autism in the province of Buenos Aires alone. Though this was a figure she calculated due to general underreporting of incidence, it's frightening that there's this perception and suspicion. Childhood vaccines in Argentina, like in other South American countries, has full thimerosal content.
Maybe that's what the Glaxo study's author meant by "only twelve"-- he's probably mentally referencing the scores of other vaccine victims in the country that the world's not even counting.
Posted by: Gatogorra | July 14, 2008 at 07:37 PM
I already signed the petition, proudly number 65.
I posted this article to a couple of different discussion groups I belong too.
What amazes me is that this is what it costs Argentina to protect the "herd" immunity in the good ole' US of A. That's just sick!!!!
Posted by: Riley's mom | July 14, 2008 at 06:30 PM
Are these expendable children? It sure sounds like the drug industry tests vaccines on the children of the poorest of poor in the world to insure that they're safe enough for American children.
Why isn't GSK testing their products on the children of their employees?
Anne Dachel
Media editor
Posted by: Anne Dachel | July 14, 2008 at 11:59 AM
"Only 12 have died throughout the country, which is a very low figure if we compare it with the deaths produced by respiratory illnesses caused by the pneumococcal bacteria.."
really? third world countries are in the habit of testing for specific strains of pneumococcal bacteria in every infant that dies of respiratory illness? Bullsh*t
And even if the above statement were true - these 12 deaths are not acceptable collateral damage.
I'm going to sign the petition now...
Posted by: Sorsha | July 14, 2008 at 11:28 AM
Below is an online petition for WORLDWIDE demand of vaccine studies, safety, and compensation by the U.S. It is a start. Many people have signed already in a matter of a few hours.
http://www.petitiononline.com/mod_perl/signed.cgi?Kids1st
Posted by: Julie | July 14, 2008 at 09:57 AM