Gardasil clinical trials -- Placebo

by Cynthia A. Janak

Cynthia A. Janak

July 23, 2008

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.

I could not wait for an answer on this so I did some digging and found a study called "Merck & Co., Inc. Study Synopsis." http://www.clinicalstudyresults.org/documents/company-study_1405_0.pdf

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

Copyright 2008 by Cynthia A. Janak