Part 2: How did Gardasil pass FDA review?

San Francisco Health Vaccines Examiner Add to favorites
Examiner Bio Part 2: How did Gardasil pass FDA review?
May 22, 3:11
2



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.

How can any official within the FDA possibly think the benefits of Gardasil outweigh the risks? Are they not there to protect the public health and safety?

Before you consent to receiving Gardasil, think about it--according to Merck's own information--you have a 75% chance of experiencing a new medical condition. Do the benefits still outweigh the risks?

Sources: Gardasil trials update--"New Medical Conditions," by Cynthia A. Janak; and Merck's prescribing information packet.

For more information on what types of new medical conditions have been reported, read Cynthia's article (link provided above). If you have more questions about Gardasil, visit www.truthaboutgardasil.org.