Ovarian Failure Data Omitted During Gardasil Trials?

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Holy Hormones Journal: Cynthia Janak is a friend and colleague… she and I have traveled this road on Gardasil for many years… and although their have been multiple twists and turns along the way… the roadblock continues to be the same. Gardasil is an endocrine disruptor – and is a dangerous vaccine to be given to any woman. PERIOD. In addition, vaccinating girls and boys at puberty the most fragile time of their life when endocrine, neurological and immune function are in fragile stages of development is dangerous – PERIOD.

Gardasil Trials

by Cynthia Janak
Health Impact News
July 2016

My Goal in Writing this Article

The key question that must be asked is this: Did Merck intentionally deceive the FDA, doctors, and parents with its Gardasil® vaccine research? In other words, did Merck design rat studies and human clinical studies that would fail to identify vaccine harm, and give a false sense of security to those who would approve or use the vaccine?

Based on the evidence I have uncovered, I believe it is possible to conclude that its future marketing plans and the protection of Merck’s profitability for its shareholders were higher priorities than the safety of the HPV vaccine called Gardasil®.

What is Merck’s Top Priority?

Please keep this statement from Merck in mind as you read about the science that I will discuss. This is what the Merck website tells us:

The primary mission of our Board is to represent and protect the long-term interests of the company’s shareholders. [7]

First Fundamental Question

Does Gardasil® Produce Endocrine Disruption?

My latest research on the Gardasil® vaccine has been to see if it causes endocrine disruption. This led me to an excellent article published in January of 2016 by the American College of Pediatricians (ACP). [1] The ACP voiced concerns about premature ovarian failure (POF) or premature menopause, which can occur after vaccination with Gardasil®. They did such a great job that I am going to quote their concerns.

The article is written as a warning to pediatricians about HPV vaccines. It tells them, “There are legitimate concerns that should be addressed.” These are the concerns they stated:

(1) Long-term ovarian function was not assessed in either the original rat safety studies, or in the human vaccine trials,

(2) Most primary care physicians are probably unaware of a possible association between HPV4 and POF and may not consider reporting POF cases or prolonged amenorrhea (missing menstrual periods) to the Vaccine Adverse Event Reporting System (VAERS),

(3) Potential mechanisms of action have been postulated based on autoimmune associations with the aluminum adjuvant used and previously documented ovarian toxicity in rats from another component, polysorbate 80,

(4) since licensure of Gardasil® in 2006, there have been about 213 VAERS reports (per the publicly available CDC WONDER VAERS database) involving amenorrhea, POF or premature menopause, 88% of which have been associated with Gardasil®. The two-strain HPV2, Cervarix™, was licensed late in 2009 and accounts for 4.7% of VAERS amenorrhea reports since 2006, and 8.5% of those reports from February 2010 through May 2015. This compares to the pre-HPV vaccine period from 1990 to 2006 during which no cases of POF or premature menopause and 32 cases of amenorrhea were reported to VAERS. [1]

There were NO cases of POF or premature menopause reported prior to 2006. Since Gardasil® and Cervarix™ were approved there have been 198 cases of amenorrhea (absence of menstruation) reported which is an 83.3% increase. This number is probably only 1% of the total cases because of under-reporting. According to David Kessler, former commissioner of the FDA, “Only about one percent of serious events are reported. Less serious vaccine adverse events (e.g., swelling, fever, or redness at the vaccination site) are more under-reported than more serious vaccine adverse events (e.g., hospitalizations and death).” [10] Further in my article I will explain why under-reporting is not only possible but probable.

More Questions

The ACP report raised several questions that I wanted to answer: What is so important about rat studies? What are the details of the case studies that were mentioned in the ACP article? How many cases of POF, amenorrhea or associated conditions have been reported to VAERS (Vaccine Adverse Event Reporting System)?

I will answer these questions in the following sections and will present detailed data from the VAERS database near the end of this article.

Could the Research Design Measure Ovarian Dysfunction?

The American College of Pediatricians stated:

Few other vaccines besides Gardasil® that are administered in adolescence contain polysorbate 80. Pre-licensure safety trials for Gardasil® used placebo that contained polysorbate 80 as well as aluminum adjuvant. Therefore, if such ingredients could cause ovarian dysfunction, an increase in amenorrhea probably would not have been detected in the placebo controlled trials. Furthermore, a large number of girls in the original trials were taking hormonal contraceptives which can mask ovarian dysfunction including amenorrhea and ovarian failure. Thus a causal relationship between human papillomavirus vaccines (if not Gardasil® specifically) and ovarian dysfunction cannot be ruled out at this time.

While data from those studies do not indicate an increased rate of amenorrhea after vaccination, the essential lack of saline placebos and the majority of participants taking hormonal contraceptives in those studies preclude meaningful data to rule out an effect on ovarian function. [1]

These statements by the ACP are very powerful. They tell us about some of the outcomes from this vaccine with regards to fertility and safety. These physicians seem very concerned that the studies did not provide meaningful data that could rule out an effect on ovarian function.

Ovarian Insufficiency Following HPV Vaccination

Australian researchers put together a case study of three young women (ages 16, 16, and 18) who experienced premature ovarian insufficiency after receiving HPV vaccine. This study is not difficult to read, and I recommend that everyone read it.

In this article, the researchers stated:

Vaccine research does not present an ovary histology report of tested rats but does present a testicular histology report. Enduring ovarian capacity and duration of function following vaccination is unresearched in preclinical studies, clinical and postlicensure studies. Postmarketing surveillance does not accurately represent diagnoses in adverse event notifications and can neither represent unnotified cases nor compare incident statistics with vaccine course administration rates. The potential significance of a case series of adolescents with idiopathic premature ovarian insufficiency following HPV vaccination presenting to a general practice warrants further research. Preservation of reproductive health is a primary concern in the recipient target group. Since this group includes all prepubertal and pubertal young women, demonstration of ongoing, uncompromised safety for the ovary is urgently required. This matter needs to be resolved for the purposes of population health and public vaccine confidence. [2]

What is interesting here is that sufficient studies were done for male rats but not for female rats. At least that is what we are led to believe by Merck’s incomplete study data.

Animal Studies are Required to Prove Safety

Animal studies are required prior to the approval of any medication or vaccine for human trials. The animal studies should be designed to identify safety issues that might come up. Merck did animal studies; but they appear to have omitted specific testing to measure the effects of their vaccine on female reproduction.

Merck Studies did not Examine Rat Ovaries

This is what the Australian research scientists learned when they tried to find out more information about the rat studies that were used to “prove” the safety of HPV vaccine. They stated:

No histology report of the vaccine-tested rodent ovary was available under Freedom of Information Request to the Therapeutic Goods Administration of Australia. There is no cellular observation available on tested rodents’ ovaries beyond a numbering of corpora lutea present on the ovary at caesarian section. [2]

What does Merck’s lack of full examination of female rats communicate?

Merck did not Give Three Doses of HPV Vaccine to the Rats

These rats only received 2 doses of the HPV vaccine, when 3 doses are required for humans. Why?

The Australian researchers stated:

In preclinical fertility studies submitted at licensing, no rats were tested with the complete vaccination course, with representative interval administration, prior to mating. The study concludes that vaccine rodent fertility testing conferred ‘a safety margin of 200-fold by body weight for adolescents.’ ‘Guidance for Industry’ research guidelines state ‘where possible we recommend that you administer the maximum human dose (eg, 1 human dose = 1 rabbit dose) regardless of body weight.’ The reason for omission of the third vaccination dose prior to measuring the rats’ capacity to conceive is unclear. [2]

Yes, it is unclear. Could it be that Merck would not want proof that the vaccine is unsafe? They need to protect their marketing plans and the interests of the shareholders with this novel vaccine.

Australian researchers further stated:

The 200-fold safety prediction was derived from the 0.25 kg (0.55 lbs.) weight of a rat compared with the “average body weight of an adolescent girl (50 kg [110.2 lbs.]).” The HPV4 target girl group is aged from 9 years and administration in Australia is to girls aged 12 and 13 years under the National Immunization Programme. The 50th centile weight of 9-year-olds is 28 kg (61.7 lbs.), of 12-year-olds is 42 kg (92.5 lbs.), and of 13-year-olds is 46 kg (101.4 lbs.). Australian age-specific weights therefore also reduce modeled calculations of fertility safety. [2]

Here in the United States, we start administering HPV injections at the age of 11. Thus, we see that the rat studies did not address fertility safety for the right age group of girls in Australia or in the United States.

Merck did not Look at Long-term Fertility

The researchers from Australia stated:

Long-term fecundity (fertility) studies of vaccinated female rodents’ duration of reproductive lifespan, recorded numbers of litters and pup numbers in subsequent litters were also requested under the original freedom of information application but were unavailable. [2]

Did Merck deliberately withhold vital information about future fertility of the litters? Could it be that this information would have damaged Merck’s Gardasil® application? We just don’t know for sure, but it causes one to wonder why the information was not available.

Read full article…

Related Article

 Adolescent Premature Ovarian Insufficiency Following Human Papillomavirus Vaccination

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Author: Leslie Carol Botha

Author, publisher, radio talk show host and internationally recognized expert on women's hormone cycles. Social/political activist on Gardasil the HPV vaccine for adolescent girls. Co-author of "Understanding Your Mood, Mind and Hormone Cycle." Honorary advisory board member for the Foundation for the Study of Cycles and member of the Society for Menstrual Cycle Research.