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I thought that maybe some people are interested in taking a look at a <b>typical clinical study.</b><br>
This one is an "efficacy, safety and immunogenicity" study.<br><br>
1. <b>NO placebo</b> is used. It is compared to another vaccine, but the word "placebo" is still used.<br>
2. The true number of side-effects is far higher than what is stated in the package insert.<br>
3. <b>63.8% expereinced one or more Adverse Events(AE)</b><br>
4. <b>9.6% experienced a Serious Adverse Event (SAE)</b><br>
5. <b>2 <span style="text-decoration:underline;">fatal</span> SAEs!</b><br>
6. The serious adverse events are removed at the stroke of a pen, for no apparent reason other than that the study-leader did not <i>consider them to be related</i> to the vaccine.<br>
7. All children were examined and considered <b>healthy before the study began</b>.<br><br>
Do the math and calculate the number of children who suffer from the virus versus how many would be likely to suffer from the vaccine.<br><br>
Here is a PDF file: <a href="http://ctr.gsk.co.uk/Summary/Vaccine_Rotavirus/II_444563_006_(rota006).pdf" target="_blank">http://ctr.gsk.co.uk/Summary/Vaccine..._(rota006).pdf</a><br><br>
Is this really as "safe as can be" for the most vulnerable and defensless little people in our society?<img alt="" class="inlineimg" src="/img/vbsmilies/smilies/dizzy.gif" style="border:0px solid;" title="Dizzy">:
 

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Discussion Starter · #2 ·
<img alt="" class="inlineimg" src="http://www.mothering.com/discussions/images/smilies/shrug.gif" style="border:0px solid;" title="shrug"> bumping just once. In case someone might find it interesting...
 

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It looks like more than 2 deaths to me, actually. But maybe I'm reading it wrong? I'm not sure what the "Death, nos" means.<br><br><div style="margin:20px;margin-top:5px;">
<div class="smallfont" style="margin-bottom:2px;">Quote:</div>
<table border="0" cellpadding="6" cellspacing="0" width="99%"><tr><td class="alt2" style="border:1px inset;">Subjects with fatal SAE(s), n(%) [n related]<br>
1 (0.2) [0]<br>
0 (0.0) [0]<br>
1 (0.2) [0]<br>
2 (0.1) [0]<br>
1 (0.2) [0]<br>
Death, nos<br>
0 (0.0) [0]<br>
0 (0.0) [0]<br>
1 (0.2) [0]<br>
1 (0.1) [0]<br>
0 (0.0) [0]</td>
</tr></table></div>
from page 23.
 

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Discussion Starter · #5 ·
<div style="margin:20px;margin-top:5px;">
<div class="smallfont" style="margin-bottom:2px;">Quote:</div>
<table border="0" cellpadding="6" cellspacing="0" width="99%"><tr><td class="alt2" style="border:1px inset;">
<div>Originally Posted by <strong>Devaskyla</strong> <a href="/community/forum/post/9988245"><img alt="View Post" class="inlineimg" src="/community/img/forum/go_quote.gif" style="border:0px solid;"></a></div>
<div style="font-style:italic;">It looks like more than 2 deaths to me, actually. But maybe I'm reading it wrong? I'm not sure what the "Death, nos" means.<br><br><br><br>
from page 23.</div>
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You are correct. There are acutally 3 deaths in this study. 2 in the vaccine-group. And 1 in the "placebo"-group (where no placebo was used, just another vaccine)..
 

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Interesting.<br><br>
I was just wondering if a new vaccine enters the market and it is the first of its kind, what do they use for the placebo if another brand isn't available?<br><br>
like Guardisil?
 

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Discussion Starter · #7 ·
<div style="margin:20px;margin-top:5px;">
<div class="smallfont" style="margin-bottom:2px;">Quote:</div>
<table border="0" cellpadding="6" cellspacing="0" width="99%"><tr><td class="alt2" style="border:1px inset;">
<div>Originally Posted by <strong>xmasbaby7</strong> <a href="/community/forum/post/9988336"><img alt="View Post" class="inlineimg" src="/community/img/forum/go_quote.gif" style="border:0px solid;"></a></div>
<div style="font-style:italic;">Interesting.<br><br>
I was just wondering if a new vaccine enters the market and it is the first of its kind, what do they use for the placebo if another brand isn't available?<br><br>
like Guardisil?</div>
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When a new vaccine enters the market it is usually<br>
A. compared to: another "similar" vaccine<br>
or<br>
B. compared to: just the vaccine without the virus-component.<br>
or<br>
C. compared to the same vaccine but administered with another vaccine in different ways. Example: Group 1 recieves the new vaccine + Infanrix. Group 2 recieves the new vaccine + Dtp, Hib etc. separately.<br><br><br>
You can read more about Gardasil clinical studies here: <a href="http://www.renewamerica.us/columns/janak/070227" target="_blank">http://www.renewamerica.us/columns/janak/070227</a>
 

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This type of thing was the final straw in convincing my husband that we weren't going to be vax'ing our children anymore (this and the difference in the number of vax's we recieved and what they want to give our girls now). Even basic chemistry classes tell students that you use an inert placebo in the control group (like normal saline for injectables) so that you get a true representation vs the experimental component. And yet a person with 4 months of medical education and 10 years as an EMT, I know more about this than the drug companies seem to (as well as many of us mommies and daddies who are so "uneducated" according to entirely too many MD's).<br><br>
Things like this are why my children will never recieve another vax as long as I have anything to say about it.
 

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Thanks for posting this. I think this info gets forgotton a lot and many don't even know aout it.
 

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So they conclude since we had a similar # of adverse reactions including death in both vaccinated groups, this new vaccine must be safe.<br><br>
Wow.<br><br>
Now let's compare to a group who didn't get vaccinated at all, how many deaths or adverse reactions you can relate to something else (since you know for sure it wasn't a vaccine)<br><br>
Would there still be enough similarities to conclude it must be "safe".
 

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Discussion Starter · #11 ·
<div style="margin:20px;margin-top:5px;">
<div class="smallfont" style="margin-bottom:2px;">Quote:</div>
<table border="0" cellpadding="6" cellspacing="0" width="99%"><tr><td class="alt2" style="border:1px inset;">
<div>Originally Posted by <strong>suschi</strong> <a href="/community/forum/post/9989319"><img alt="View Post" class="inlineimg" src="/community/img/forum/go_quote.gif" style="border:0px solid;"></a></div>
<div style="font-style:italic;">So they conclude since we had a similar # of adverse reactions including death in both vaccinated groups, this new vaccine must be safe.<br><br>
Wow.<br><br>
Now let's compare to a group who didn't get vaccinated at all, how many deaths or adverse reactions you can relate to something else (since you know for sure it wasn't a vaccine)<br><br>
Would there still be enough similarities to conclude it must be "safe".</div>
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Yes. Thats the global "golden standard" of vaccine safety research since the 1940´s.<br><br>
It's NEVER compared to a true placebo (Only vaccines are allowed to be tested this poorly). If it had been compared to a true placebo, no vaccine would ever be allowed to be given to any living human or animal.<br><br>
Did I mention that ALL kids in the study underwent medical examination before the study began? They were all declared healthy and with no history of auto-immune disorders, neurological disorders etc. in their family.<br>
Just days later they get very sick, and even die.<br><br>
And it's always brushed off as a coincidence. <img alt="" class="inlineimg" src="http://www.mothering.com/discussions/images/smilies/shrug.gif" style="border:0px solid;" title="shrug">
 

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<div style="margin:20px;margin-top:5px;">
<div class="smallfont" style="margin-bottom:2px;">Quote:</div>
<table border="0" cellpadding="6" cellspacing="0" width="99%"><tr><td class="alt2" style="border:1px inset;">
<div>Originally Posted by <strong>Re:search</strong> <a href="/community/forum/post/9989740"><img alt="View Post" class="inlineimg" src="/community/img/forum/go_quote.gif" style="border:0px solid;"></a></div>
<div style="font-style:italic;">Yes. Thats the global "golden standard" of vaccine safety research since the 1940´s.<br><br>
It's NEVER compared to a true placebo (Only vaccines are allowed to be tested this poorly). If it had been compared to a true placebo, no vaccine would ever be allowed to be given to any living human or animal.<br><br>
Did I mention that ALL kids in the study underwent medical examination before the study began? They were all declared healthy and with no history of auto-immune disorders, neurological disorders etc. in their family.<br>
Just days later they get very sick, and even die.<br><br>
And it's always brushed off as a coincidence. <img alt="" class="inlineimg" src="http://www.mothering.com/discussions/images/smilies/shrug.gif" style="border:0px solid;" title="shrug"></div>
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Oh yeah, that was one of my wake up calls, this vaccine was tested in healthy children, but once licensed, it will be given to all no matter their state of health, that right there should CRIMINAL !
 

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<div style="margin:20px;margin-top:5px;">
<div class="smallfont" style="margin-bottom:2px;">Quote:</div>
<table border="0" cellpadding="6" cellspacing="0" width="99%"><tr><td class="alt2" style="border:1px inset;">
<div>Originally Posted by <strong>MeniacleBrat</strong> <a href="/community/forum/post/9988379"><img alt="View Post" class="inlineimg" src="/community/img/forum/go_quote.gif" style="border:0px solid;"></a></div>
<div style="font-style:italic;">Even basic chemistry classes tell students that you use an inert placebo in the control group (like normal saline for injectables) so that you get a true representation vs the experimental component. And yet a person with 4 months of medical education and 10 years as an EMT, I know more about this than the drug companies seem to (as well as many of us mommies and daddies who are so "uneducated" according to entirely too many MD's).</div>
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I have addressed the placebo issue numerous times; most recently here: <a href="http://www.mothering.com/discussions/showthread.php?t=795583&highlight=placebo&page=2" target="_blank">http://www.mothering.com/discussions...placebo&page=2</a><br><br>
The use of a saline or PBS placebo would be appropriate if you are testing a constituent of a vaccine, not appropriate for testing the vaccine effects themselves.<br><br>
SM
 

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<div style="margin:20px;margin-top:5px;">
<div class="smallfont" style="margin-bottom:2px;">Quote:</div>
<table border="0" cellpadding="6" cellspacing="0" width="99%"><tr><td class="alt2" style="border:1px inset;">
<div>Originally Posted by <strong>Science Mom</strong> <a href="/community/forum/post/9990088"><img alt="View Post" class="inlineimg" src="/community/img/forum/go_quote.gif" style="border:0px solid;"></a></div>
<div style="font-style:italic;">I have addressed the placebo issue numerous times; most recently here: <a href="http://www.mothering.com/discussions/showthread.php?t=795583&highlight=placebo&page=2" target="_blank">http://www.mothering.com/discussions...placebo&page=2</a><br><br>
The use of a saline or PBS placebo would be appropriate if you are testing a constituent of a vaccine, not appropriate for testing the vaccine effects themselves.<br><br>
SM</div>
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So, what does that mean for this study?
 

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DP, There was a placebo used for this trial. The assertion that other vaccines were used as placebos is incorrect; other vaccines were used as sub-studies and tested against the vaccine and the placebo. The main study consisted of 3 different numbers of infectious particles against the placebo. An easier to read version appears in this issue of <a href="http://www.pediatrics.org/cgi/content/full/peds.2006-2630v1" target="_blank"><i>Pediatrics</i></a> and states:<br><div style="margin:20px;margin-top:5px;">
<div class="smallfont" style="margin-bottom:2px;">Quote:</div>
<table border="0" cellpadding="6" cellspacing="0" width="99%"><tr><td class="alt2" style="border:1px inset;"><i>The HRV and placebo prepared by reconstituting the lyophilized product with the supplied diluent (calcium carbonate buffer). Each reconstituted dose (1 mL) consisted of 104.7, 105.2, or 105.8 IU of HRV, strain RIX4414 (GlaxoSmithKline Biologicals). The placebo had the same constituents as the active vaccine but without the vaccine virus.</i></td>
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Does this answer your question?<br><br>
SM
 

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<div style="margin:20px;margin-top:5px;">
<div class="smallfont" style="margin-bottom:2px;">Quote:</div>
<table border="0" cellpadding="6" cellspacing="0" width="99%"><tr><td class="alt2" style="border:1px inset;">
<div>Originally Posted by <strong>Science Mom</strong> <a href="/community/forum/post/9991270"><img alt="View Post" class="inlineimg" src="/community/img/forum/go_quote.gif" style="border:0px solid;"></a></div>
<div style="font-style:italic;">DP, There was a placebo used for this trial. The assertion that other vaccines were used as placebos is incorrect; other vaccines were used as sub-studies and tested against the vaccine and the placebo. The main study consisted of 3 different numbers of infectious particles against the placebo. An easier to read version appears in this issue of <a href="http://www.pediatrics.org/cgi/content/full/peds.2006-2630v1" target="_blank"><i>Pediatrics</i></a> and states:<br>
Does this answer your question?<br><br>
SM</div>
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Do you think they were right to dismiss the deaths as unrelated to the vaccines in this particular trial? If yes, why?
 

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<div style="margin:20px;margin-top:5px;">
<div class="smallfont" style="margin-bottom:2px;">Quote:</div>
<table border="0" cellpadding="6" cellspacing="0" width="99%"><tr><td class="alt2" style="border:1px inset;">
<div>Originally Posted by <strong>Deborah</strong> <a href="/community/forum/post/9991284"><img alt="View Post" class="inlineimg" src="/community/img/forum/go_quote.gif" style="border:0px solid;"></a></div>
<div style="font-style:italic;">Do you think they were right to dismiss the deaths as unrelated to the vaccines in this particular trial? If yes, why?</div>
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Well, you tell me:<br><div style="margin:20px;margin-top:5px;">
<div class="smallfont" style="margin-bottom:2px;">Quote:</div>
<table border="0" cellpadding="6" cellspacing="0" width="99%"><tr><td class="alt2" style="border:1px inset;"><i>Two children died: 1 in the placebo group with a diagnosis of sudden infant death 18 days after administration of the first dose and 1 in the 105.8-IU group as a result of an automobile accident 43 days after administration of the second vaccine dose.</i></td>
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SM
 

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I thought there were 3 deaths. And what shots were given to the infant who died in the placebo group? I'm assuming he was given the usual battery of shots that have already been 'proven' safe?
 

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<div style="margin:20px;margin-top:5px;">
<div class="smallfont" style="margin-bottom:2px;">Quote:</div>
<table border="0" cellpadding="6" cellspacing="0" width="99%"><tr><td class="alt2" style="border:1px inset;">The HRV and placebo prepared by reconstituting the lyophilized product with the supplied diluent (calcium carbonate buffer). Each reconstituted dose (1 mL) consisted of 104.7, 105.2, or 105.8 IU of HRV, strain RIX4414 (GlaxoSmithKline Biologicals). <b>The placebo had the same constituents as the active vaccine but without the vaccine virus.</b></td>
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so, the placebo was the vaccine product minus the virus? including adjuvants and preservatives?
 

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<div style="margin:20px;margin-top:5px;">
<div class="smallfont" style="margin-bottom:2px;">Quote:</div>
<table border="0" cellpadding="6" cellspacing="0" width="99%"><tr><td class="alt2" style="border:1px inset;">
<div>Originally Posted by <strong>Science Mom</strong> <a href="/community/forum/post/9991270"><img alt="View Post" class="inlineimg" src="/community/img/forum/go_quote.gif" style="border:0px solid;"></a></div>
<div style="font-style:italic;">DP, There was a placebo used for this trial. The assertion that other vaccines were used as placebos is incorrect; other vaccines were used as sub-studies and tested against the vaccine and the placebo. The main study consisted of 3 different numbers of infectious particles against the placebo. An easier to read version appears in this issue of <a href="http://www.pediatrics.org/cgi/content/full/peds.2006-2630v1" target="_blank"><i>Pediatrics</i></a> and states:<br>
Does this answer your question?<br><br>
SM</div>
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Thanks!
 
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