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Do you know how vaccines are evaluated for safety? Prepare to be surprised. - Page 3

post #41 of 189
Quote:
Originally Posted by LongIsland
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:
Well, geesh- I wonder if that Hep B vaccine was held to the rigorous standard that this was:
Quote:
Originally Posted by LongIsland
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.
It seems that their methods would mean more and more AE the further they get down the line. Vax A has only a small increase in the reactions compared to B. Which had only a small increase in reactions compared to C. etc etc.
post #42 of 189
Quote:
Originally Posted by LongIsland
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.
I've seen a study comparing thimerosal like that. It divided the groups into those with exposure of 200 and more, 150 to 200, 75 to 150, and 0 to 75. (I'm making up those numbers, but its something like that.) There was no category for no thimerosal exposure through vaccines. Even if they STARTED off with one, they didn't end up with one.

It frustrates me to no end that they can't/won't do a study that actually says something about the safety of vaccines!!!!!!!
post #43 of 189
Quote:
Originally Posted by Plummeting
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.
So are you suggesting that they pick the worst studies, the ones least likely to show that the products are safe, to include in the package insert? They purposely pick and choose between the multitudes of studies, and choose the only research that wasn't properly conducted using a placebo? The research that makes their product seem more dangerous and less effective? They have better studies to choose from, but they use the worst ones to describe their drugs in the package inserts?

That defies all logic, and it's also complete bullsh*t. Drug companies choose the studies that make their products look more effective, safer and better researched. That's how they do business. They're out to make money and sell product. That means they put their best face forward, not their worst.
My thoughts exactly.

And ccohenou, can you point the way to ONE study that actually compares health between vaxed and never vaxed individuals? For any vaccine? I've been looking for such a study.
post #44 of 189
To strengthen a persons trust : in the FDA and CDC one ought to read the Lab 57.

Its thought we can thank Lyme's disease to the lab and it not being careful.

It also mentioned in the book how carefully everything is handled. Like one would really want to trust any info that comes from the results of studies and trials out of a place like that.
post #45 of 189
Quote:
Originally Posted by Deva33mommy
And ccohenou, can you point the way to ONE study that actually compares health between vaxed and never vaxed individuals? For any vaccine? I've been looking for such a study.
Unfortunately, it looks like she's taken the tactic of insinuating that we are all simpletons, who think that only children who've never been exposed to any toxins or drugs of any kind, in any way, will qualify as a control group. You know, that whole "Adam and Eve" comment? In reality, she knows that what we're looking for - vaccine studies comparing a group of children who receive the vaccine, with a group of children who receive an inert injection - does not exist. Whether or not she's willing to admit that this has some obvious implications about the safety of vaccines and their components remains to be seen.

Ccohenou, you can't honestly believe that asking a drug company to do a REAL study, in which the control group is actually a control group, is somehow impossible. For what other reason do you think the term 'placebo' exists in so many articles, studies, etc? When they say 'placebo', are we to believe that they're actually referring to another drug? I see ads in the paper all the time, looking for drug study participants. They frequently refer to placebos. Surely they use placebos because that is the best way to study the effects a drug has on those to whom it's given. That's what we're saying they need to do with vaccines. Arguing this point is just silly. If they don't safety test a vaccine using a placebo, how are we to believe they're as "safe" as they claim they are - especially given how many toxins they contain, and what some of those toxins are known to do in the body?
post #46 of 189
Thread Starter 
Associated Press (7/06):

Drug makers routinely fail to file status reports with the federal government that show what kind of progress they have made in conducting safety studies.

That's the conclusion of a review from the inspector general for the Health and Human Services Department. Investigators found that 35 percent of status reports that drug makers were supposed to file in fiscal year 2004 were missing entirely or contained no information on agreed-to studies.

"Monitoring postmarketing study commitments is not a top priority at the (Food and Drug Administration)," the investigators conclude



But this is the best part of the article:

But [FDA Commish] von Eschenbach said the agency cannot instruct drug applicants to provide additional, meaningful information in their status reports. "A provision for additional information would require that new regulations be written," he said.
post #47 of 189
I'm sure this is in a FAQ somewhere, but I looked at the stickies and didn't find the answer. Where can I find the text of vaccine package inserts -- do the vaccine makers have them online somewhere?
post #48 of 189
Thread Starter 
Quote:
Originally Posted by tamagotchi
I'm sure this is in a FAQ somewhere, but I looked at the stickies and didn't find the answer. Where can I find the text of vaccine package inserts -- do the vaccine makers have them online somewhere?
Click on the brand name and it will open up to the product insert: http://www.vaccinesafety.edu/thi-table.htm

You can also find inserts for any drug or biological product at the FDA website (fda.gov) searching by product name. The manufacturer website also has the prescribing information as well. The link above is better though b/c everything's at one link.
post #49 of 189
Thanks!
post #50 of 189
i didn't see this asked/mentioned but Can you imagine siging your baby up to be a tester??????
post #51 of 189
Quote:
Originally Posted by comfybuns
i didn't see this asked/mentioned but Can you imagine siging your baby up to be a tester??????

I was thinking the same thing and wondering how they even go about doing that? Have a woman sign under duress while in labor?
post #52 of 189
Thanks for the post Long Island. Some startling information there!

Problem is that the information is being preached to the choir. If we could figure out how to get it out to everyone else we would be on to something.

Can you imagine how a doctor could willingly inject a vax into a baby's arm after reading that? Do they read it or are they so medically indoctrinated that they just vax on blind faith alone?

Makes you want to blow it up on a billboard on a busy traffic jammed highway somewhere, doesn't it?

Good info though...I bet that took some time to find...
post #53 of 189
Quote:
Originally Posted by melissabb
Can you imagine how a doctor could willingly inject a vax into a baby's arm after reading that? Do they read it or are they so medically indoctrinated that they just vax on blind faith alone?
I wonder this myself especially with my neighbor. She's a ped who also has a PhD in nutritional sci. She bfs, grows her own organic food, any store-bought food is organic, thinks hydrogenated oils are evil, raises chickens for eggs (she lives in town not on farm), cloth diapers, etc. yet I know she vaxes her daughter. I've always really wanted to ask her about that but I don't know her well enough to go there, iykwim.
post #54 of 189
Quote:
Originally Posted by LongIsland
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.
Although I agree totally that big Pharma doesn't conduct the research they should with actual placebos, I can tell you that they really weren't trying to hide something by doing their analysis that way (combining the two control groups). A serious AE might only have an incidence of 1 in 3,000. You can't statistically conduct an analysis for a serious adverse event that occurs very infrequently in a sample of 320 individuals. What they should have done had saline placebo in the entire control group.
post #55 of 189
Given that the mild reactions were higher in the Aluminium group and they separated them, they still should have separated out the serious one, and let people actually see for themselves.
post #56 of 189
Thread Starter 
Quote:
Originally Posted by HeatherHeather
I can tell you that they really weren't trying to hide something by doing their analysis that way (combining the two control groups).
I completely understand what you're saying regarding statistics; however, they did publish the data for the two placebo groups when comparing non-serious adverse events.

Why didn't they publish the data for the serious AE's? Why publish one and not the other?
post #57 of 189
Quote:
Originally Posted by Momtezuma Tuatara
Given that the mild reactions were higher in the Aluminium group and they separated them, they still should have separated out the serious one, and let people actually see for themselves.
I'd love to see that data, but they can't do it - it's statistically invalid and wouldn't be "good science". Actually it protects both ways. Say for example that a serious AE occurs 1 in every 1,000 children. You have no way of knowing if that 1 person will be the first one that you give the injection to or the last one (in the group of 1,000). If it were the first one in the group of 320, then your AE rate would be higher in analysis for the saline control group. The rate would be 1 in 320 or 3.1 per 1,000. That would give the saline control group a 3 times higher rate of the AE compared to the alum. control group's rate of 1 in 1,000. Hypothetically of course.

Is this clear? Sometimes I don't explain myself well.
post #58 of 189
Quote:
Originally Posted by LongIsland
I completely understand what you're saying regarding statistics; however, they did publish the data for the two placebo groups when comparing non-serious adverse events.

Why didn't they publish the data for the serious AE's? Why publish one and not the other?
This is because the non-serious AE rate is higher and it makes it a scientifically valid comparison. The non-serious AEs might occur 1 in 100 or 1 in 10 which you can assess in a sample size of 320. If the AE occurs in greater than 1 in 320 you can't make a scientifically valid analysis of the group separately.

I was posting above while you were posting - see it for how this protects the control group as well.
post #59 of 189
Thread Starter 
Quote:
Originally Posted by HeatherHeather
I'd love to see that data, but they can't do it - it's statistically invalid and wouldn't be "good science".
Then why publish the comparison data for non-serious AE's? ETA: saw your post.

This begs the question -- what was the point of creating a placebo control sub-group?
post #60 of 189
The thing I don't understand is why have a control group that small to begin with.
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