When we as a people hear about clinical studies and the word 'Placebo' comes up
we think that it contains nothing more than a solution of saline (salt water) or
is nothing more than a sugar pill. In clinical trials this would be called the
control group.
What I want to do is get into a little history behind 'Placebo' taken from one
of my favorite reference sites Wikipedia.
Originally, a placebo was a substance that a well-meaning doctor would give
to a patient, telling him that it was a powerful drug (e.g., a painkiller), when
in fact it was nothing more than a sugar pill. Thus, Hooper's medical dictionary
of 1811 says placebo is "an epithet given to any medicine adapted more to please
than benefit the patient." The subsequent reduction of the patient's symptoms
was attributed to the patient's faith in his doctor and hence his belief in the
drug. (This category, particularly before the first Medicines Act was passed,
may merge into fake medicines.)
So, pretty much, my thoughts of a 'Placebo' were that it is was nothing more
than a harmless salt-water solution or pill. I have also done a quick poll of my
friends and they have the same thoughts as I do in regards to the definition of
'Placebo.'
Why am I bringing your attention to one insignificant word? It is because in
recent days this word has become very significant in the clinical trials of
Gardasil and other vaccines and drugs. How so, you ask? It is because Merck and
other pharmaceutical companies have a different idea of what a 'Placebo' really
is in clinical trials.
What I have before me is a 464 page document that was further brought to my
attention by another researcher. This person made several comments as to the
studies that made me further scrutinize this document.
http://www.fda.gov/cber/review/hpvmer060806r.pdf
What I am going to do is show you the proof that Merck, in my opinion,
intentionally mislead the public and the FDA with their reports and graphs by
using something other than a saline placebo in their clinical trials.
In this FDA document I want you to note that Study 018 is the only study
where a saline placebo was used. All the other studies the placebo had 'amophous
aluminum hydroxide sulfate.'
I have a problem with these numbers of the non-alum placebo group. I am going to
show you why with the next tables from a fifteen page document from Merck.
http://www.gardasil.com/downloads/gardasil_pi.pdf
What I am going to reference here is page 11.
You can see that there is a big difference here. Let us take a layman's look at
these events.
Pain, I can see that there would be comments about pain because you are getting
a needle stuck in your arm and stuff being forcibly injected under the skin. But
why such an increase between the aluminum and the saline? Could there be an
issue with the aluminum and the immune system? Could be!
Swelling, that makes sense too because you are getting stuff injected in one
area so you should have some swelling. Again, a dramatic increase in the
aluminum over the saline.
Erythema, considering that you have been stuck with a needle and stuff is
injected in the arm you could experience reddening so this one makes sense also.
Pruritus, is more of an allergic reaction because the definition of this is an
intense feeling of itchiness. I would equate it to a mosquito bite maybe. We are
allergic to the mosquito venom so we itch. I want to point out the difference
here. You are seeing a huge increase in the allergic reaction between the
aluminum and the saline.
Let us go on to the next chart. As you can see the Merck people intentionally
combined the Aluminum Placebo group with the Saline Placebo group. I find it
interesting how the percentage difference in Systemic Adverse Experiences
changes when you combine the Saline Placebo with the Aluminum Placebo. It does
not look so bad now does it? Any lay person would think that the vaccine was
pretty safe with these numbers.
My question is how the heck did the FDA buy into this? I thought that they were
professionals that understood and critiqued these studies before approval. My
opinion of them has changed dramatically.
Now let us look at table 7. Merck did the same thing with this one. They merged
the saline group with the aluminum group to make the numbers appear to be in
their favor. Once again, did not the FDA pick up on this obvious deception? I
guess not.
Let us compare table 237 and table 7. This makes me wonder how truthful the
title is in table 237.
I have a problem with these two sets of numbers. How could we have such a
difference in the saline group and the aluminum group in table 6 but you do not
have much of a difference with table 237 and table 7? I would think that the
percentages would be more in line with each other. Could this be location or
ethnic difference depending on where the study was taken? I do not know. The
other thing that bothers me is that if you are giving someone a true saline
placebo why are they having any side-effects at all except for pain? If someone
could explain this to me I would appreciate it.
This study along with asking a few questions from a friend at a university for
clarification, my question that I proposed was answered. Here is what I found.
In the study group 018 the saline placebo was not a true saline placebo. This
placebo was a non-alum carrier solution placebo. What that means is that the HPV
virus and the virus-like particles are omitted along with the aluminum
adjudicant. You can see that with these two charts.
What I find interesting here is that the FDA document Table 7 (the first table I
presented) tells us it is only a saline solution but in this Merck document it
states that it was a carrier solution and not saline only.
With this new information, it is my opinion, that Merck snowed the FDA into
believing that this vaccine was safe. They omitted information from the FDA
document that could have proved that this vaccine was not safe. I do not think
that the FDA would have approved this vaccine if they had all the information.
Another thing that I have noticed since writing all my articles on this vaccine
is that the Quadrivalent HPV (6, 11, 16, 18) L1 VLP are not the major cause of
the side-effects that we are seeing today. What I have found by looking at all
the studies and charts it is the ingredients of the 'carrier solution' and the
aluminum adjuvant that are the causes of the majority of the side-effects.
So logically I cannot say that the vaccine is the cause of the horrendous
side-effects that I have been reporting about. It is Merck's addition of the 225
mcg of aluminum (as amorphous aluminum hydroxyphosphate sulfate adjuvant), 9.56
mg of sodium chloride, 0.78 mg of L-histidine, 50 mcg of polysorbate 80, 35 mcg
of sodium borate, and intentional, in my opinion, omission in the reporting of
the ingredients of the so called saline placebo to the FDA.
So given all the information that I have accumulated over the last year and a
half on Gardasil, it is my opinion, that Merck has been negligent and willfully
omitted information that could have postponed the approval of their vaccine. It
is my opinion that they felt that they were in a race to get their HPV vaccine
to market first and reap the benefits that an aggressive marketing campaign to
the public and the doctors. It is also my opinion that Merck is also responsible
for the doctors not having all the information presented to them to make an
educated decision whether to push this vaccine on to their patients.
NOTE: If anyone is curious about the ingredients in vaccines and you live in the
Illinois or Indiana area please come to the Trinity Christian College, Ozinga
Chapel, 6601 West College Drive, Palos Heights, Illinois 60463. The speakers for
this event will be Mary Tocco, Mayer Eisenstein, M.D. and Dr. Ashly Ochsner.
Call this number for tickets. 708-349-0040
Cynthia Janak is a freelance journalist, mother of three, foster mother of one,
grandmother of five, business owner, Chamber of Commerce member. Her expertise
is as an administrative professional. Her specialties are adoptee and genealogy
research and research journalism. Hobbies: Writing prose, crocheting,
Conservative Studies, and rehabbing houses. You can contact Cynthia Janak at
cj1951@ameritech.net
