Do you know how vaccines are evaluated for safety? Prepare to be surprised. - Mothering Forums

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#1 of 189 Old 07-09-2006, 02:35 PM - Thread Starter
 
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This is a spin-off of the VAERS thread, which will look at the safety trial methods for infant/childhood vaccines. The purpose of this thread is to show that vaccines are not properly tested for safety. In fact, many vaxers may be in for a shock. I will be using the product insert, which contains efficacy and safety data.

I'm going to begin with ActHib (Sanofi). ActHib was tested for safety by giving one group ActHib w/ DTP and the CONTROL GROUP was given Hep B w/ DTP. Here is a snippet from the product insert:


In a randomized, double-blind US clinical trial, ActHIB® was given concomitantly with DTP to more than 5,000 infants and Hepatitis B vaccine was given with DTP to a similar number.

In this large study, deaths due to sudden infant death syndrome (SIDS) and other causes were observed but were not different in the two groups.

In the first 48 hours following immunization, two definite and three possible seizures were observed after ActHIB® and DTP in comparison with none after Hepatitis B vaccine and DTP. This rate of seizures following ActHIB® and DTP was not greater than previously reported in infants receiving DTP alone. (Refer to product insert for AvP DTP.) Other adverse reactions reported with administration of other Haemophilus b conjugate vaccines include urticaria, seizures, hives, renal failure and Guillain-Barré syndrome (GBS). A cause and effect relationship among any of these events and the vaccination has not been established.
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#2 of 189 Old 07-09-2006, 02:43 PM - Thread Starter
 
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Next is the safety trial for Tripedia (DTaP) Wyeth. One group received Tripedia and the CONTROL GROUP received Aventis' whole cell DTP vaccine.

In a double-blind, comparative US trial, 673 infants were randomized to receive either 3 doses of Tripedia vaccine or AvP’s whole-cell pertussis DTP vaccine (Table 2).

Safety data are available for 672 infants, including 505 who received Tripedia vaccine and 167 who received whole-cell pertussis DTP vaccine. Following all three doses, rates for all reported local reactions, fever > 101°F, irritability, drowsiness, and anorexia were significantly less in Tripedia vaccine recipients. Reaction rates generally peaked within the first 24 hours, and decreased substantially over the next two days.2,27,28

A similar reduction in adverse events was seen in a randomized, double-blind, comparative trial conducted in the US by the NIH when Tripedia vaccine was compared to Lederle Laboratories whole-cell pertussis DTP vaccine
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#3 of 189 Old 07-09-2006, 02:59 PM - Thread Starter
 
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There are a lot more vaccines to cover in this thread, but I wanted to see if some of you are able to figure out why the FDA allows this to happen and why manufacturers use this sort of method.

This method is used in order to make sure adverse event outcomes are statistically insignificant between the two groups . . . if you can do that . . . you've got yourself a licensed vaccine, which will promptly be placed on the coveted recommended schedule of childhood immunizations.

I also want to point out that serious adverse event outcomes are particularly important to pharma . . . they need to be able to show that serious AE's between the vaccine group and the control group are statistically insignificant or else the vaccine's use in infants/children will be limited.

This is precisely why vaccines are NOT evaluated for safety on infants/children/adults prior to licensure with any known mild and serious health conditions and premature infants.
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#4 of 189 Old 07-09-2006, 03:10 PM - Thread Starter
 
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AE - adverse event

The newly licensed Gardasil (HPV) Merck. The Gardasil group had 5,088 subjects. The reason why I'm listing the number of subjects will be clear when you read the next few sentences.

The first CONTROL group received an alumiminum-containing placebo (3,470 subjects). The second control group received a saline placebo (only 320 subjects). When comparing minor AE's, Merck compared data for both placebo groups. However, when comparing data for serious AE's, Merck COMBINED the two placebo groups and then compared it to the Gardasil group.

They do not reveal the difference in serious AE's between the aluminum placebo group and the saline group.
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#5 of 189 Old 07-09-2006, 03:27 PM - Thread Starter
 
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Energix B (Hep B) Glaxo The CONTROL GROUP received plasma-derived vaccines. The vaccines administered to the CONTROL GROUP are not revealed.

Ten double-blind studies involving 2,252 subjects showed no significant difference in the frequency or severity of adverse experiences between ENGERIX-B and plasma-derived vaccines.

In 36 clinical studies, a total of 13,495 doses of ENGERIX-B were administered to 5,071 healthy adults and children who were initially seronegative for hepatitis B markers, and healthy neonates. All subjects were monitored for 4 days post-administration.
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#6 of 189 Old 07-09-2006, 03:32 PM - Thread Starter
 
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Recombivax HB (Hep B) Merck
This vaccine was not evaluated for safety using a control group.

In three clinical studies, 434 doses of RECOMBIVAX HB, 5 mcg, were administered to 147 healthy infants and children (up to 10 years of age) who were monitored for 5 days after each dose.

In a study that compared the three-dose regimen (5 mcg) with the two-dose regimen (10 mcg) of RECOMBIVAX HB in adolescents, the overall frequency of adverse reactions was generally similar.

In a group of studies, 3258 doses of RECOMBIVAX HB, 10 mcg, were administered to 1252 healthy adults who were monitored for 5 days after each dose.
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#7 of 189 Old 07-09-2006, 03:35 PM
 
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It is just so f-ing unbelievable. Makes me want to move out of the USA.

Amy, mommy to Ava, 6, Gavin, 4, Lila, 2, and Baby #4 due in early November! joy.gif
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#8 of 189 Old 07-09-2006, 03:41 PM
 
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LI,
im sure im not the only one, but wanted to say i appreciate you posting this info. its very useful to me and i want to make sure you don't get discouraged by no replies.

i am not a statician and am still trying to wrap my mind around the issue of these tests. one question i have is what the significance of combining the control groups when considering the rates of serious AE's.

thanks
rach
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#9 of 189 Old 07-09-2006, 03:42 PM - Thread Starter
 
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Infanrix (DTaP) Glaxo
The CONTROL GROUP was given DTP or there was no control group.


Approximately 92,000 doses of INFANRIX have been administered in clinical studies. In these studies, 28,749 infants have received INFANRIX in primary series studies, 5,830 children have received INFANRIX as a fourth dose following 3 doses of INFANRIX, and 511 children have received INFANRIX as a fifth dose following 4 doses of INFANRIX. In addition, 439 children and 169 children have received INFANRIX as a fourth or fifth dose following 3 or 4 doses of whole-cell DTP vaccine, respectively. In comparative studies, the first 4 doses of INFANRIX have been shown to be followed by fewer of the local and systemic adverse reactions commonly associated with whole-cell DTP vaccination.

In the double-blind, randomized comparative trial in Italy, safety data in a 3-dose primary series are available for 4,696 infants who received at least one dose of INFANRIX and 4,678 infants who received at least one dose of US-licensed whole-cell DTP vaccine manufactured by Connaught Laboratories, Inc. All common solicited adverse events were less frequent following vaccination with INFANRIX as compared to whole-cell DTP after each 1 of the 3 doses.
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#10 of 189 Old 07-09-2006, 03:42 PM - Thread Starter
 
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MMR II Merck

The CONTROL GROUP received a monovalent or bivalent vaccine containing measles, mumps, or rubella.




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#11 of 189 Old 07-09-2006, 04:24 PM - Thread Starter
 
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Prevnar (Wyeth)

The majority of the safety experience with Prevnar comes from the NCKP Efficacy Trial in which 17,066 infants received 55,352 doses of Prevnar, along with other routine childhood vaccines through April 1998.

The "other routine childhood vaccine" was DTaP and CONTROL GROUPS were given Meningitis C (conjugate) vaccine.
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#12 of 189 Old 07-09-2006, 04:29 PM
 
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Thank you for posting all this, Long Island. I love when you do this!
Quote:
Originally Posted by LongIsland
There are a lot more vaccines to cover in this thread, but I wanted to see if some of you are able to figure out why the FDA allows this to happen and why manufacturers use this sort of method.

This method is used in order to make sure adverse event outcomes are statistically insignificant between the two groups . . . if you can do that . . . you've got yourself a licensed vaccine, which will promptly be placed on the coveted recommended schedule of childhood immunizations.

I also want to point out that serious adverse event outcomes are particularly important to pharma . . . they need to be able to show that serious AE's between the vaccine group and the control group are statistically insignificant or else the vaccine's use in infants/children will be limited.

This is precisely why vaccines are NOT evaluated for safety on infants/children/adults with any known mild and serious health conditions and premature infants.
I just finished reading The Anti-Depressant Fact Book by Dr Peter Breggin. In it, he says,
"The Food and Drug Administration (FDA) has forsaken its watchdog role. Instead, FDA officials climb like puppies into the lap of the drug company executives who might some day hire them at enormous salaries."
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#13 of 189 Old 07-09-2006, 04:30 PM - Thread Starter
 
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IPOL (Inactivated Polio) Sanofi

Because IPV was given in a different site but concurrently with Diphtheria and Tetanus Toxoids and Pertussis Vaccine Adsorbed (DTP), these systemic reactions could not be attributed to a specific vaccine. However, these systemic reactions were comparable in frequency and severity to that reported for DTP given alone without IPV.
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#14 of 189 Old 07-09-2006, 04:31 PM
 
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This is why it's so freakin frustrating talking to people who insist that the vaccines must be safe, since the FDA allowed them to go to market. You can't judge adverse events like autoimmune disorders or allergies by following people for a few days. And you can't judge ANYTHING by comparing your vaccine to another shot containing some of the same toxic ingredients. : That doesn't seem to bother people at all.

Apparently, they'd be happy with a study that followed people who ate nothing but twinkies for 5 days, while the control group ate nothing but brownies for 5 days. The study would conclude, after only 5 days, that no one had died or suffered any serious adverse events, and the minor reactions were equal between groups, therefore, eating nothing but twinkies must be safe. If you explain it like that, it suddenly becomes ludicrous, because *everyone* knows you can't survive on twinkies alone, but they just can't quite see how you could possibly draw a comparison between that and vaccine studies. <sigh>
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#15 of 189 Old 07-09-2006, 04:34 PM - Thread Starter
 
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Quote:
Originally Posted by annalily
Thank you for posting all this, Long Island. I love when you do this!
I was jumping up and down inside when DH said he wanted to take my younger one to big brother's baseball awards get together! I was like . . . yay! I can do my thread!!!!! I'm hoping we can get this immortalized into a sticky.

Quote:
Originally Posted by annalily
I just finished reading The Anti-Depressant Fact Book by Dr Peter Breggin. In it, he says,
"The Food and Drug Administration (FDA) has forsaken its watchdog role. Instead, FDA officials climb like puppies into the lap of the drug company executives who might some day hire them at enormous salaries."
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#16 of 189 Old 07-09-2006, 04:39 PM - Thread Starter
 
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Quote:
Originally Posted by Plummeting
This is why it's so freakin frustrating talking to people who insist that the vaccines must be safe, since the FDA allowed them to go to market.
But of course VAERS is unreliable.
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#17 of 189 Old 07-09-2006, 04:52 PM - Thread Starter
 
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Quote:
Originally Posted by aisraeltax
one question i have is what the significance of combining the control groups when considering the rates of serious AE's.
The non-serious adverse events between the saline placebo group compared to the aluminum-containing placebo group and Gardasil group WERE significant. They had no problem showing the data because they were "minor" reactions like fever, injection site swelling, etc.

Can you imagine what the comparison of serious adverse events revealed . . . and Merck doesn't want to reveal it for some reason. Not to mention what would have been revealed if the control group was ENTIRELY made up of saline placebo subjects.
This is the first time I've seen a true saline placebo used in a vaccine safety trial . . . and they only use 320 subjects . . . and then hide the serious adverse event data for those subjects.

I'm going to do RotaTeq next. I think these trials did use true placebos, but I have to dig a little more later.
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#18 of 189 Old 07-09-2006, 06:54 PM
 
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More later, but suffice to say that package inserts do not contain a complete rundown of every study conducted on a drug. So putting these few out there as if This Is It is misleading.
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#19 of 189 Old 07-09-2006, 06:56 PM
 
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Thank you for your hard work L.I. I saved it to hard drive! This is beautiful-infuriating, but beautiful.
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Very, very interesting LI! I would like to see a pro-vax'er defend this.

I worry more about long term effects, than short term (overall). Sore arms, fevers dont bother me. GBS, autoimmune diseases, etc bother me, that should bother everyone.

Marilyn,psych RN. Homeschooling mom to Taylor (12) and Lauryn (8)
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#21 of 189 Old 07-09-2006, 07:01 PM
 
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LI, when I showed this thread to DP his eyes bugged out and he said to me "Thank you for not vaccinating our children."

Thank you for this reassurance.
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#22 of 189 Old 07-09-2006, 07:04 PM
 
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If I am grasping this correctly the tests are run this way becasue if they ran the test comparing a salene injection over a longer peroid of time those test would prove the appaling rate of injury, illness and death casueed by a vaccine.:
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#23 of 189 Old 07-09-2006, 07:23 PM - Thread Starter
 
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Quote:
Originally Posted by ccohenou
More later, but suffice to say that package inserts do not contain a complete rundown of every study conducted on a drug. So putting these few out there as if This Is It is misleading.
We are not concerned with post-marketing studies relating to efficacy or immunogenicity . . . this is a thread regarding the PROPER AND ETHICAL evaluation of pre-marketing SAFETY.

Ya know, what pharmaceutical companies should be doing BEFORE a vaccine is licensed for use.

This thread is not misleading.
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#24 of 189 Old 07-09-2006, 07:57 PM
 
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Hate to butt in when you are on a roll, but I just want to mention something else.

1) First vaccines are tested in animals.

But as we all realise, and our provaccine friends do not, even FDA/CDC http://www.fda.gov/cber/minutes/tox120202.htm admits that first, these vaccines are NOT tested for toxicity because they have always been presumed safe, and in this FDA/CDC discussion about that they couldn't agree on animal models on which to toxicity test vaccines, which would mimic new born babies, becuase they didn't know enough about newborn animals to know if using them to test vaccines would be comparable to humans.

2) In all vaccine trials children are specially selected. No children are allowed who have chronic illness, intercurrent illness, family histories of immunodeficiency or allergy, who were under a certain weight at birth, experience anoxia or other birth problems... the list is endless.

Usually this knocks out about 60% of children, leaving 40% supposedly pristine useful kids to prove a vaccine safe.

Then when the vaccine supposedly comes through as safe, and EVEN THERE there will have been reactions which are also called "coincidental" and dismissed... the vaccine is licensed.

At which point if you are a mother of a baby who was underweight at birth, had anoxia, but is coming right, but you have a family history of immunodefiency and allergies you are then told that your child especially needs this vaccine because your child is so much more at risk.

And yes, the vaccine tested safe in trials using children.

Except they never tested it on kids like yours, did they?

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#25 of 189 Old 07-09-2006, 07:58 PM
 
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This is a great thread. DH trusts my judgment about vaxes already but I may have him read it anyway just to underline the point.
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#26 of 189 Old 07-09-2006, 08:02 PM
 
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Quote:
Originally Posted by ccohenou
More later, but suffice to say that package inserts do not contain a complete rundown of every study conducted on a drug. So putting these few out there as if This Is It is misleading.
Absolute CRAP.

So here will be your next post


Quote:
fictious post by ccohenou and I am in the honoured priviledged position where I get to see all the trial results and the studies which say totally different things to what they give you the parent to see


You have the classic provacciners shift the goal post syndrome.

As your president so loves to say Bring... it... on!!!


:nana: laughup

“I want to sell drugs to everyone. I want to sell drugs to healthy people. I want drugs to sell like chewing gum.” former Merck CEO, Henry Gadsden

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#27 of 189 Old 07-09-2006, 08:05 PM
 
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Quote:
Originally Posted by ccohenou
More later, but suffice to say that package inserts do not contain a complete rundown of every study conducted on a drug. So putting these few out there as if This Is It is misleading.
Right, now that I'm back to normal, please explain why?

If parents are given this information upon which to make a decision, why is it misleading?

After all, the fabricated fictious post I attributed to you, is pretty much tantamount to what you are saying, and it is quite outrageous to suggest that vaccine companies say one thing in their studies and publish bull dust.

Either their published material, which they write and is approved by FDA is accurate or it is not.

So cough up, if you are privy to information that we aren't... spit it out woman!

“I want to sell drugs to everyone. I want to sell drugs to healthy people. I want drugs to sell like chewing gum.” former Merck CEO, Henry Gadsden

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#28 of 189 Old 07-09-2006, 08:32 PM - Thread Starter
 
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Quote:
Originally Posted by ccohenou
package inserts do not contain a complete rundown of every study conducted on a drug
Unless you know something I don't, vaccine product inserts contain data on all efficacy and safety trials conducted prior to the FDA's licensure of a vaccine. The trials contained in this thread are the very trials the FDA used to determine the vaccine's safety.
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#29 of 189 Old 07-09-2006, 09:10 PM
 
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Quote:
Originally Posted by LongIsland
The FDA, CDC and pharma don't encourage the insert's routine distribution and know the trial data won't be read and scrutinized by the "average" parent.
They are around every vial in the doc's fridge in this country. If they aren't for distribution what are they for? To give the nurse some arm exercise as she chucks each one out?

“I want to sell drugs to everyone. I want to sell drugs to healthy people. I want drugs to sell like chewing gum.” former Merck CEO, Henry Gadsden

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#30 of 189 Old 07-09-2006, 09:14 PM - Thread Starter
 
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Quote:
Originally Posted by Momtezuma Tuatara
They are around every vial in the doc's fridge in this country. If they aren't for distribution what are they for? To give the nurse some arm exercise as she chucks each one out?

To line the doc's kitty litter?

We've heard some stories here of the docs and nurses using some interesting tactics in order to discourage parents from reading the insert. For instance, some have said things like:

"Oh, you wouldn't understand it anyway"

"You can read it, but you can't take it with you b/c it's the last one we have"

"Don't you trust me?"



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