Gardasil trials update–“New Medical Conditions”

Gardasil trials update–“New Medical Conditions”

By Cynthia A. Janak

…I found an interesting document on the FDA website about my favorite topic, Gardasil.

Subject: Clinical Review of Biologics License Application Supplement for Human Papillomavirus Quadrivalent (Types 6, 11, 16, 18) Vaccine, Recombinant (Gardasil®) to extend indication for prevention of vaginal and vulvar cancers related to HPV types 16 and 18.

Dated September 11, 2008

This document is 187 pages long and I was scanning this document for adverse events. I did find something interesting starting on their page 132; it was Table 73, titled “New Medical Conditions” Days 1–15…

The total study participants were 5088 for Gardasil and 3790 for the Placebo. (Now let us remember that this group includes the Alum and carrier solution placebos.) The participants that they were able to follow-up with were 5012 for Gardasil and 3725 for the Placebo group.

What caught my eye with this table was the fact that these participants did not have these conditions prior to the study. I surmise this because of the title “New Medical Conditions”. So in essence these individuals were probably healthy average people with active lives and families.

Here is what I found.



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