Part 2: How did Gardasil pass FDA review?

Examiner.com

May 22, 3:11 AMVaccines ExaminerNorma Erickson

In the first article questioning how Gardasil passed the FDA review prior to approval of the license to unleash the HPV vaccine on the general population, the information represented was quoted from the prescribing information packet given to medical professionals responsible for dispensing this supposed miracle cure for cervical cancer.

Almost immediately after publication, I received a request from Cynthia A. Janak, a research journalist, asking me to take a look at some of the information Merck presented to the FDA prior to Gardasil’s approval. After carefully reviewing the information, it is my opinion that no one in their right mind would think the potential benefits of Gardasil outweigh the risks involved when this vaccine is injected.

According to Merck’s Gardasil prescribing information packet, out of the 20,118 healthy young women who were injected with either Gardasil, or their proprietary AAHS ‘control’ solution, there were 463 reports of 19 different new medical conditions that occurred after enrollment in the clinical trials. Also, according to the same information packet, these new conditions were indicative of systemic autoimmune disorders. 463 reports out of a population of 20,118 is roughtly 2%. To many people, that is an acceptable risk for the benefits HPV vaccines are supposed to offer.

Unfortunately, this is not the same information that was presented to the FDA. According to the information Merck presented to the FDA, out of 21,464 participants who were injected with either Gardasil, or the AAHS control solution, there were 16,180 reports of 77 different new medical conditions occurring after enrollment in their clinical safety trials. 16,180 reports out of a population of 21,464 is 75%.

That means, according to the information presented by Merck to the FDA, out of every four people who consent to take Gardasil, three will experience some sort of new medical condition. These potential ‘new medical conditions’ include a laundry list of almost everything that can go wrong with a human body. Do the benefits still outweigh the risks?

Which information is one supposed to believe? Obviously one of these two documents is not accurate; but, both sets of information originated from the same source–Merck.

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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.