Sunday, March 9, 2008

Gardasil Vaccine, Medical deception

This phrase, "The placebo consisted of the same adjuvant", only appears in two documents on the world wide web.

The placebo consisted of the same adjuvant

OK now it appears in three documents. This being the third one. I find that hard to believe, but you can do a search yourself with Google, Google Scholar, Google News, and Google blog search, and discover this for yourself.

(edit) Google already found this entry! It even lists it on the web search. (/edit)

It appears here,
and here, broken link->

One is a broken link, the other wants 39 US dollars to read it. Considering the volume and page numbers have question marks, I think I will try an alternative method of finding the article.
International Journal of Gynecological Cancer
Vol. 0 Issue 0 Page ???

Safety and immunogenicity of a vaccine targeting human papillomavirus types 6, 11, 16 and 18: a randomized, placebo-controlled trial in 176 Korean subjects


It doesn't really matter, the issue isn't with the article at all. It is with the entire methodology of how they "tested" the Gardasil vaccine. During the clinical trials, they didn't use a placebo, they used amorphous aluminum hydroxyphosphate sulfate as the placebo.

Here is the abstract for the trial.

We performed a randomized, double-blind, placebo-controlled study in 176 volunteers aged 9-23 years. Using a 2:1 ratio for randomization, 117 women were assigned to quadrivalent HPV (20 mug type 6, 40 mug type 11, 40 mug type 16, and 20 mug type 18) vaccine and 59 women to placebo. Individuals received vaccine at day 1, month 2, and month 6 and provided blood samples for analysis at enrollment at month 7. Analyses were done as specified in the study protocol. Quadrivalent HPV vaccine was generally well tolerated, with no vaccine-related serious adverse experiences. Quadrivalent HPV vaccine induced seroconversion for each vaccine-related HPV type. At month 7, vaccine-induced type-specific antibody titer was high. In conclusion, administration of quadrivalent HPV VLP vaccine to Korean women aged 9-23 years was generally well tolerated and highly immunogenic.

Note the bolded parts of the abstract. Just like all the other abstracts about Gardasil and clinical trials, they don't tell you the truth. They didn't use a Placebo, they used amorphous aluminum hydroxyphosphate sulfate dissolved in saline solution.

I am not making this up. So when they claim there were no adverse effects, they are comparing the vaccine to a big slug of aluminum injected into muscle tissue. Let me repeat that.

So when they claim there were no adverse effects, they are comparing the vaccine to a big slug of aluminum injected into muscle tissue.

You might think that is more than a bit deceptive. Because it is. In fact, it is a huge deception. It makes the entire clinical trial an example of bad science, bad medicine, and it is the opposite of Evidence Based Science.

How could the FDA approve that? How can anyone who is a scientist look at that and not see it?

This could be an entire series. This is unbelievable. As a scientific, rational person, I am deeply disturbed by this.

Which brings us back to that phrase,
"The placebo consisted of the same adjuvant". Redefining placebo isn't just against the rules, it is against the very basis of science, medicine and evidence based science.


Darcy Archer said...

How is 225 µg of amorphous aluminum hydroxyphosphate sulfate considered "a big slug of aluminum"? The LD50 is 4640mg/kg. Let's do the math, shall we?

225 ug = 0.225 mg

For those of you still trying to follow along.... the amount considered a "Big slug of aluminum" is less than 1/4 of a mg. it takes 3,000 mg to make you slightly ill and almost 5,000 mg is the dose required to kill half the members of a tested population after a specified test duration.

Watch out for claims of "Evidenced based". Do your own research. Dig for your answers of who, what, when, where, why, how and how much. People say and twist what they want to in order to fill their own agendas.

S F X said...

When testing something, the placebo effect is ruled out by using a placebo. This is to be able to dismiss symptoms and side effects that have nothing to do with the material being injected.

If the placebo is not an inert substance, or worse, it consists of material being tested, it is useless as a placebo.

The phrase "big slug" was hyperbole.