Gardasil, a subsidiary of pharma giant Merck, received FDA approval for the vaccine in 2006. However, the ACP is concerned with studies that link the vaccine to premature ovarian failure.
In a letter released in January 2016, the American College of Pediatricians wrote, “It has recently come to the attention of the College that one of the recommended vaccines could possibly be associated with the very rare but serious condition of premature ovarian failure (POF), also known as premature menopause.”
In addition to serious concerns about premature ovarian failure, ACP physicians are concerned with the testing methodology that led to vaccine approval. The letter of concern notes,
“Nevertheless there are legitimate concerns that should be addressed: (1) long-term ovarian function was not assessed in either the original rat safety studies3,4 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 used1 and previously documented ovarian toxicity in rats from another component, polysorbate 80,2 and (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®.5 The two-strain HPV2, CervarixTM, 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.”
Yet, the state of Rhode Island is requiring that all public and private school students be vaccinated in the seventh grade. Unless parents file a medical or religious exemption form, 7th graders in Rhode Island will be forced to submit to the vaccination.
Health safety issues are not Gardasil’s only problem. For years, consumer advocates have questioned Merck’s slick advertising campaigns concerning the vaccine. Ethical issues have been raised concerning a drug company that is no stranger to such controversy.