Merck Roulette

A look at the data used to approve Gardasil

The Gardasil vaccine, developed by Merck & Co., was first approved by the FDA on June 8, 2006. In December 2014, the FDA approved Gardasil 9, which is supposed to provide protection against five additional HPV types. Touted as the first vaccine ever for cancer, it has been a financial windfall for the company.

For the full year of 2021, vaccines brought in approximately $9.7 billion in sales revenues for Merck, with Gardasil and Gardasil 9 accounting for $5.7 billion of this total, marking a 44% increase from the previous year. In 2022, Gardasil and Gardasil 9 generated $6.897 billion, reflecting a 22% increase compared to the $5.673 billion reported in 2021​.

Originally, Gardasil was approved for use in girls and women ages 9 through 26 years but then with the most recent version that has been expanded to women and men aged 27 to 45. That is quite the leap in market share in just a decade or so, as reflected in the revenues pouring into Merck’s coffers. As with all vaccines, Gardasil is obviously “safe and effective” because the FDA and its European counterpart the EMA would never allow a product to be rolled out worldwide to be injected into its populations youth without making sure it was right?

The only way to truly know is to have a look at the data those agencies used to inform their decision to enrich the company they will potentially be working for in the future and that is exactly what I did.

Let’s start with the basics to ask oneself. What did they use as a control to test the drug? Common sense would dictate that is should be a placebo.

In case you are not familiar with what a real placebo is I have provided a definition. As you can see it is supposed to be an inert, innoccuous substance that looks just like the drug being tested and consist of nothing bioactive, like saline. By doing this the safety profile can be assessed properly. Compare the bioactive ingredients effect on the person to something that is well known to have very minimal effect, thus affording the researchers the ability to gain a clear understanding of the potential adverse effects the product may have on the human being. Again, common sense right?

One would think so but in the magical world of “vaccine science” the manufacturers have granted themselves the ability to test their products against other vaccines or an adjuvant, even the exact same adjuvant they plan on using in the product itself. Not only that the FDA is on board sees no problem with this.

Why is this allowed? Good luck finding a straight answer to that one but anyone who is being honest will tell you it is because they know that if they were to use simple inert saline, their products adverse reaction disparity would be untenable for the FDA to justify its approval. Hence the need to “control” the outcome by using a “placebo” that is guaranteed to produce adverse reactions.

Thus when viewing the data, the disparity gap significantly closes, portraying the product as relatively safe compared to “placebo”. I have yet to hear a cogent, ethical reason for conducting trials for new drugs in this manner. Usually the response is some type of bioethics sophistry that is designed to infer that you are too stupid to understand the complexities of vaccine ethics.

This is exactly what Merck did in the Gardasil clinical trials. They used a neurotoxic aluminum adjuvant called Aluminum Hydroxyphosphate Sulfate instead of using an inert saline placebo. They also use it in the vaccine itself.

Front of Gardasil 9 box

"Amorphous Aluminum Hydroxyphosphate Sulfate (AAHS) is one of a half a dozen distinct forms of aluminum adjuvants present in vaccines, including the PedvaxHIB, Vaqta HepA, and Gardasil Human Papillomavirus (HPV). Studies have found 100% of the intramuscularly injected aluminum vaccine adjuvant is absorbed into the systemic circulation and travels to different sites in the body such as the brain, joints and the spleen where it accumulates and is retained for years post-vaccination.

A 2017 peer-reviewed report found evidence of numerous adverse events reported after vaccination with Merck’s Gardasil vaccines, including life-threatening injuries, permanent disabilities, hospitalizations and deaths."

https://childrenshealthdefense.org/known-culprits/aluminum/amorphous-aluminum-hydroxyphosphate-sulfate-aahs/

Gardasil's clinical trials found that among girls and women who received the vaccine as well as the girls and women who received AAHS, an unbelievable 2.3% in both groups experienced conditions indicative of “systemic autoimmune disorders,” many shortly after receiving Gardasil.

Among girls and women who received the vaccine as well as the girls and women who received AAHS, an unbelievable 2.3% in both groups experienced conditions indicative of “systemic autoimmune disorders,” many shortly after receiving Gardasil.

235 in the Gardasil group and 218 in the fake placebo group

https://www.fda.gov/media/74350/download?attachment

The original clinical trials were conducted by Merck in Denmark. In the advertisement for them they lied to study participants, falsely saying that the clinical trials were not safety studies, that the vaccine had already been found to be safe and that the “placebo” was an inert saline solution.

[Source: The HPV Vaccine on Trial  (photo evidence, pp. 6 and 12).]

When Merck conducted clinical trials for its next HPV vaccine formulation, Gardasil 9, it used Gardasil as the “placebo” in the control groups, again relying on the lack of an inert placebo to mask safety signals. I pulled this directly from the trial data which can be found within the package insert. I’ll also note that they followed up for 5 days post injection, an absurdly short amount of time if you are truly trying to assess safety.

Another screenshot further confirming that that actually used their own product as a control to assess safety. I wonder why they don’t advertise these major details?

While reviewing the insert I noticed a couple other interesting things. Each group had 5 deaths within 678 days of the injections. Gardasil 9 had one from an automobile accident, which can reasonably eliminated as a  being related but the others I’m not so sure, a suicide, maybe can be explained as unrelated but more information would be needed on the circumstances. We know that many girls have been maimed to the extent that they are suffering tremendously and this could pprecipitate suicide.

The other death were from Acute lymphocytic leukemia which is a type of cancer of the blood and bone marrow that affects white blood cells., hypovolemic septic shock which happens when you lose a lot of blood or fluids. Causes include internal or external bleeding, dehydration, burns, and severe vomiting and/or diarrhea. and an unexplained sudden death are the others.

In the Gardasil group there was also an automobile accident and a plane crash, as well as a gunshot wound that resulted in deaths. That leaves cerebral hemorrhage or otherwise known as a ruptured blood vessel causes bleeding inside the brain and a stomach adenocarcinoma which is stomach cancer.

All of the deaths were ruled unrelated to the injections.  It is important to note that all participants were deemed to be healthy prior to being enrolled in the study. We will never truly know if it was related to the injections and that is part of the problem as I see it.

(Gardasil 9 Insert) https://www.fda.gov/media/90064/download

Yet another odd choice made by the study designers was that they decided to give use

500 micrograms of aluminum adjuvant (AAHS) in Gardasil 9 which is more than double the amount of aluminum in Gardasil raising serious questions about Gardasil 9’s heavy reliance on the Gardasil trials for comparison is justifiable.

A screenshot showing the 500mcg for Gardasil 9

(Gardasil 9 Insert) https://www.fda.gov/media/90064/download

A screenshot showing the 225mcg of AAHS for Gardasil

(Gardasil Insert) https://www.fda.gov/media/74350/download

I found this document entitled:

“Expert Consultation on the Use of Placebos in Vaccine Trials”

https://iris.who.int/bitstream/handle/10665/94056/9789241506250_eng.pdf;jsessionid=6A3C2F4EB89230EF3D69D854B149EA80?sequence=1

In it The World Health Organization states that using a vaccine (rather than an inert substance) as a placebo creates a “methodological disadvantage” and also notes that it may be “difficult or impossible” to assess vaccine safety properly without a true placebo.

Then why not just use an inert saline placebo? Read the underlined paragraphs below, the reasoning employed is really astounding.

“The motivation for using active rather than inert “placebos” is to fulfill the ethical duty of beneficence and sometimes to avoid giving an injection with an inert substance.”

https://iris.who.int/bitstream/handle/10665/94056/9789241506250_eng.pdf;jsessionid=6A3C2F4EB89230EF3D69D854B149EA80?sequence=1p pop

The Gardasil clinical trials had a long list of criteria that needed to be met for someone to participate. They were not allowed to participate in the trials were people with: severe allergies; prior abnormal Pap test results; over four lifetime sex partners; a history of immunological disorders and other chronic illnesses; reactions to vaccine ingredients, including aluminum, yeast, and benzonase; or a history of drug or alcohol abuse.

The only problem with this is that Merck and the FDA now recommends Gardasil for all of these groups. There haven’t been studies done with individuals that fall into those categories so how can they know it ok to recommend?

Here are some screenshots of Mercks confidential study protocols pulled from the 127 page report:

https://www.scribd.com/document/367386168/V501-015-00-PRO-VD?secret_password=j4BXCUs76g4wRtDxk5cy

Some of the study participants but not all were given “report cards” to record short-term reactions such as redness and itching.

The report cards monitored reactions for only 14 days, however, and Merck did not follow up with participants who experienced serious adverse events such as systemic autoimmune or menstrual problems.

Salon conducted an investigation into the trials and found that Mercks methodology to track side effects to be very flawed:

“To track the safety of its product, the drugmaker used a convoluted method that made objective evaluation and reporting of potential side effects impossible during all but a few weeks of its yearslong trials. At all other times, individual trial investigators used their personal judgment to decide whether or not to report any medical problem as an adverse event essentially, as a potential side effect worth evaluating further. Other health issues went on a worksheet for “new medical history,” reserved for conditions that bore no relation to the vaccine.”

Look at what the journalist was told by experts interviewed for the investigation:

“Experts I talked to were baffled by the way Merck handled safety data in its trials. According to Dr. Yoon Loke, a professor at the University of East Anglia who studies side effects, letting investigators judge whether adverse events should be reported is “not a very safe method of doing things, because it allows bias to creep in.”

“A drug-safety adviser at a multinational pharmaceutical company told me, “Everything from the first injection to the last plus a follow-up period is what we call treatment-emergent adverse events.” She puzzled over the brief, interrupted follow-up periods in the Gardasil trials, as well as Merck’s choice not to report nonserious adverse events for all participants and its dismissal of many events as medical history. “This is completely bonkers,” she said, requesting not to be named for fear of compromising her position in the industry. “They’ve set up a protocol that seems very poorly thought through from a medical and safety perspective.”

https://slate.com/health-and-science/2017/12/flaws-in-the-clinical-trials-for-gardasil-made-it-harder-to-properly-assess-safety.html

“Safe and Effective”

Injured participants in the trial also complained that Merck rebuffed their attempts to report adverse side effects. In numerous instances, Merck maintained that these “weren’t related to the vaccine.”

Half (49.6%) of the clinical trial subjects who received Gardasil reported serious medical conditions within seven months. To avoid classifying these injuries as adverse events, Merck dismissed them as “new medical conditions.”

Cervical cancer risk-benefit

The global average age of cervical cancer death is 59 years old and yet Gardasil targets and is administered to millions of healthy preadolescents and teens for whom the risk of dying from cervical cancer is practically zero. Interventions for healthy people must have a risk profile that is also practically zero and after reviewing the clinical trials I think it is more than fair to say that the risks are much higher than that.

https://pubmed.ncbi.nlm.nih.gov/31812369/#:~:text=The%20global%20average%20age%20at,%25)%20of%20185%20countries%20assessed

With 76 million children vaccinated at an average cost of $420 for the three-shot Gardasil series, the cost of saving one American life from cervical cancer amounts to about $18.3 million dollars.

https://childrenshealthdefense.org/news/rfk-jr-video-and-facts-about-gardasil/

By contrast, the value of a human life according to the Department of Health and Human Services’s (HHS’s) National Vaccine Injury Compensation Program is $250,000—the maximum amount that the government program will award for a vaccine-related death.

Women who get the Gardasil vaccine as preteens or teens are more likely to skip cervical cancer screening as adults, mistakenly assuming that HPV vaccination is a replacement for screening and that the vaccine will eliminate all risk.

https://pubmed.ncbi.nlm.nih.gov/26844141/

Fertility

Accumulating evidence points to Gardasil’s potentially severe adverse effects on fertility. This study was published showing the potential adverse effects on fertility but was retracted after a letter was sent to the editor demanding so. This even though it was peer reviewed.

https://www.tandfonline.com/doi/abs/10.1080/15287394.2018.1477640

I found the letter from the author responding to the retraction, I am going to republish a snippet of the response by the author, I encourage you to read it in full. I believe it shows that it wasn’t warranted and more of a political move than anything else. Since everyone knows the response is never read as much as the retraction notice. Shame on the Journalist of Toxicology and Environment for caving to such nonsense.

In their letter to the editor, Shibata and Kataoka,offer a critique of my paper, “A lowered probably of pregnancy in females in the USA aged 25–29 who received a human papillomavirus vaccine injection”. They suggest three reasons why my conclusion that HPV vaccine uptake is related to lowered probability of ever having been pregnant could be spurious. While the lowered fertility I found among women who received the HPV shot could be related to variables other than the HPV vaccine, the finding cannot be the result of the reasons they offer. The authors do not explain my findings, and their analysis does not negate the need for more research into the possible effect of the HPV vaccine on fertility.”

https://www.tandfonline.com/doi/full/10.1080/21645515.2019.1622977?src=recsys

That isn’t the only paper that has found problems related to fertility potentially related to Gardasil. This study shows that miscarriage and premature ovarian failure are potential issues.

https://pubmed.ncbi.nlm.nih.gov/23902317/

“We documented here the evidence of the potential of the HPV vaccine to trigger a life-disabling autoimmune condition. The increasing number of similar reports of post HPV vaccine-linked autoimmunity and the uncertainty of long-term clinical benefits of HPV vaccination are a matter of public health that warrants further rigorous inquiry.”

For anyone, including Merck to claim there is no link between their product and fertility issues is extremely spurious because according to

Mercks own trial data it never tested the vaccine for fertility effects. They only conducted small trials in rats.

However, Gardasil and Gardasil 9 clinical trials showed high spontaneous miscarriage rates of 25% and 27.4%, respectively.

This is significantly higher than the background rates of approximately 10%-20% in this reproductive age group.

https://www.mayoclinic.org/diseases-conditions/pregnancy-loss-miscarriage/symptoms-causes/syc-20354298

Polysorbate 80 and sodium borate (Borax) are associated with infertility in animals. Both are Gardasil ingredients, and both were present in the one clinical trial protocol that professed to use a benign saline placebo

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4528880/

In 2015, Denmark opened five new “HPV clinics” to treat children injured by Gardasil. Over 1300 cases flooded the clinics shortly after their opening.

https://sanevax.org/gardasil-firestorm-in-denmark/

Since Gardasil came on the U.S. market in 2006, people have reported over 450 deaths and over 61,000 serious medical conditions from HPV vaccines to the Vaccine Adverse Event Reporting System (VAERS).

Meanwhile our regulatory agencies somehow missed or ignored everything I just went over and continually allow the age at which someone can get this product to expand, guaranteeing Merck and their “public/private partnerships” billions of dollars.

I hope if you are a parent thinking about injecting your child with this product, you will reconsider in light of the information I have just provided and ask yourself why Merck or your government hasn’t.

If I haven’t convinced you yet, consider this:

• You are 100 times more likely to suffer a severe event following vaccination with Gardasil than they are to get cervical cancer.

• The chances of getting an autoimmune disease from Gardasil, even if the vaccine works, are 1,000 times greater than the chances of being saved from a cervical cancer death.

Is it worth it to enrich other people?