What is the placebo?

[littlec]

I've been reading on the safety studies the CDC discusses in the pink books, and I was wondering, they say "the results were similar to the placebo". What are they using as a placebo? Another vaccine? A saline solution? Just curious. Thanks.

[mamadelbosque]

Another vaccine.

[littlec]

Originally Posted by mamadelbosque

Another vaccine.

Really???

So, how can they tell if it's safe- assuming the other vaccine has similar ingredients?

Is there anywhere I can find this info? (I believe you- I'm just trying to print up a bunch of stuff).

[mamadelbosque]

Yeah, its such a scam. The fact that they don't *really* do placebo controlled trials on vaccines is one of my biggest reasons for not trusting them. I just don't get it - we insist on true placebos for everything else, but vaccines? Nope. Just another drug. Makes *no* sense to me.

[Deborah]

Actually, no, drug companies also test other stuff against established drugs. Because you can't leave a sick person untreated.

I got this from a book I read on Vioxx.

One of the Vioxx studies tested it against a well-established painkiller. There was an increase in heart disease deaths in the Vioxx arm. Merck argued that the well-established painkiller had a previously unnoticed protective effect against heart problems.

[Fyrestorm]

Here is a great example of a study that was done for Gardasil. They actually used a saline placebo (I know- shocker!) What's interesting is how they manipulate the data.

In the tables starting on page 5, they have 3 columns. One for the vaccine, one for the aluminum containing control and a 3rd for the saline placebo. But by the time you get to page 7 and the tables showing systemic adverse reaction..miraculously, the three columns have become two and the placebo has been combined with the aluminum containing control.

Data manipulation at it's best.

http://www.merck.com/product/usa/pi_...ardasil_pi.pdf

[littlec]

quote removed ~amnesiac

Thank you!

[Otto]

Originally Posted by Fyrestorm

In the tables starting on page 5, they have 3 columns. One for the vaccine, one for the aluminum containing control and a 3rd for the saline placebo. But by the time you get to page 7 and the tables showing systemic adverse reaction..miraculously, the three columns have become two and the placebo has been combined with the aluminum containing control.

I'm failing to see the scandal here, unless you think that breaking out the saline group would be more damning to the AAHS control group, which would in turn be less damning to the Gardasil group.

[ma2two]

Originally Posted by Otto

I'm failing to see the scandal here

Because comparing Gardasil to a "saline placebo"* would show that Gardasil had a lot of adverse reactions. But if you compare Gardasil to an aluminum shot, the difference in adverse reactions won't be as much. Most in the control groups got aluminum shots. Only a small fraction got "saline placebo." It's almost as if they did that just for show. But instead of showing the difference in adverse reactions between Gardasil and "saline placebo," they lump the "saline placebo" in with the aluminum shots, making it look like Gardasil doesn't cause many adverse reactions compared to the control group.

* The "saline placebo" in the Gardasil safety studies is not actually saline. It is the carrier solution, which means everything in Gardasil except the HPV virus and aluminum. This is not indicated in the package insert. It is buried in an obscure FDA document. Read this article for more information. http://www.ageofautism.com/2010/05/a...guardians.html

Also, here is the Gardasil package insert. http://www.fda.gov/downloads/Biologi.../UCM111263.pdf

[ma2two]

Originally Posted by littlec

I've been reading on the safety studies the CDC discusses in the pink books, and I was wondering, they say "the results were similar to the placebo". What are they using as a placebo? Another vaccine? A saline solution? Just curious. Thanks.

The "placebos" in vaccine safety studies are either other vaccines, or aluminum shots, or thimerosal shots.

In the Gardasil safety studies, most in the control group got an aluminum shot as the "placebo." A small number of people got a shot containing the Gardasil carrier solution, which was everything in Gardasil except HPV virus and aluminum. The package insert very deceptively calls this a "saline placebo."

Here are all the package inserts, where you can get the details for each vaccine. http://www.fda.gov/BiologicsBloodVac.../ucm093833.htm

[Sileree]

A good link about this:

How vaccines are evaluated for safety

http://insidevaccines.com/wordpress/...ed-for-safety/

[ma2two]

Originally Posted by Sileree

A good link about this:

How vaccines are evaluated for safety

http://insidevaccines.com/wordpress/...ed-for-safety/

Excellent link. It clearly spells it out. You can then go to the package inserts to verify the information.

[Otto]

Originally Posted by ma2two

Because comparing Gardasil to a "saline placebo"* would show that Gardasil had a lot of adverse reactions. But if you compare Gardasil to an aluminum shot, the difference in adverse reactions won't be as much.

I thought, however, that Gardasil was in fact AAHS adjuvanted, so the comparison is "aluminum shot" versus "aluminum shot with VLPs."

[ma2two]

Originally Posted by Otto

I thought, however, that Gardasil was in fact AAHS adjuvanted, so the comparison is "aluminum shot" versus "aluminum shot with VLPs."

Close. When Gardasil is compared to an aluminum shot, the comparison is aluminum shot versus aluminum shot with VLPs and carrier solution.