Young Women Continue to be Harmed From the HPV Vaccine

The Human Papillomavirus (HPV) vaccine was first approved by the FDA in 2006; Merck's Gardasil and GlaxoSmithKline's Cervarix are currently on the market and recommended as a three dose series for all young adults between nine and 25 years of age. While the CDC and vaccine manufacturers claim these products do not pose significant risks to the young individuals they are intended to protect, the number of reports of young women who have been harmed by this vaccination continue to mount. Medical professionals are also becoming aware of the hazards; the The American College of Pediatricians (ACP) recently issued a warning to the public voicing concerns related to the impact the HPV vaccine could be having on the reproductive health of young women. Upon close examination of Merck's initial safety research of their Gardasil vaccine, side effects related to ovarian function were not adequately tested; independent researchers have clearly stated the link between the HPV vaccine and premature ovarian failure (POF) cannot be dismissed.

Reports of Adverse Effects Continue to Mount

Data collected by the Vaccine Adverse Events Reporting System (VAERS) reveals more than 40,000 total adverse events related to the HPV vaccine between 2006 and 2015, 235 of which were deaths. Nearly 300 claims have been filed with the Vaccine Injury Compensation Program (VICP), 49 of which have been settled to the tune of nearly $6 million in total payouts based on 2013 data. The following conditions suspected to be related to the HPV vaccine which have been reported to VAERS include:

  • Amenorrhoea (lack or menstruation) or irregular menstruation;
  • Dysmenorrhoea (unusually painful menstruation);
  • Menopause or premature menopause (POF);
  • Seizures and/or loss of consciousness;
  • Extreme fatigue, muscle pain, weakness, rheumatoid arthritis and/or multiple sclerosis;
  • Inflammation of brain tissue, Guillain Barre Syndrome (GBS) and optic neuritis.

Sadly, the above is far from a comprehensive list of problems associated with the HPV vaccine; even more troubling is the fact that only one percent of adverse reactions related to vaccinations are believed to be officially reported, according to Dr. David Kessler, former head of the FDA.

Professionals Issue Warning Regarding HPV Vaccine

The ACP issued a warning statement to medical professionals and the general public in early 2016 voicing concerns over a possible link between the HPV vaccine and POF in young women. Pediatricians in this organization believe that:

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

"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..."

"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)..."

They site data from VAERS which reveals zero reported cases of POF prior to the year 2006, when the HPV vaccine was initially released. Since then, nearly 200 POF cases have been reported. ACP members also acknowledge these numbers likely represent only a small fraction of actual POF cases which began shortly after an HPV vaccine.

Poorly Designed Initial Safety Studies

After observing an increase in the number of young women experiencing POF in their country, Australian researchers began to search for and uncover shocking oversights which occurred during Merck's initial safety studies of Gardasil. They note many puzzling findings:

  • Testicular histology reports were completed for male rats, yet ovarian histology reports for female rats were not provided;
  • Rats were only given one or two doses of Gardasil, despite recommendations that humans receive three;
  • No data surrounding the long term fertility of female rats was available;
  • The effects on fertility were ignored for the majority of individuals who participated in phase II and III of human trials. Phase III participants over the age of 16 were required to use oral contraceptives during the study and continue usage for a seven month period thereafter (hormonal contraceptives are known to affect the menstrual cycles of women). Those under 16 years of age were considered too young to have established a regular pattern of menstruation. These two factors were used as reasoning to explain the lack of fertility testing.
  • A subgroup of 448 individuals from one trial which contained a total of 5916 participates was evaluated for menstrual dysfunction for a period of 14 days. Considering the average woman's menstrual cycle is 28 days, this time period was said to provide meaningless data.

The researchers summarized their concerns in the following statement:

"Underrepresentation of the vaccine’s target age group, incomplete and short-term follow-up, definition limitations, hormone usage, fortnight restrictions of vaccine report card documentation and the decision not to report new medical conditions as adverse events which occurred post month seven from first vaccination compromised safety studies’ observation of ovarian health."

Was Merck Fraudulent During Initial Studies of Gardasil?

One has to wonder how Merck convinced the FDA to approve Gardasil despite the lack of fertility data provided. While vaccine manufacturers have immunity from liability claims as a result of the 1986 National Childhood Vaccine Injury Act, there is one exception; manufacturers who have utilized fraudulent practices before or during the licensure process may be held liable for damages. If you or someone you love has been harmed by the HPV vaccination, working with a professional attorney is critical to receive the compensation you need to get your life back in order.

 

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