Norma Erickson
Denver Examiner
05/21/2010
Consider the questions raised by Merck’s prescribing information packet on Gardasil. Of the 20,118 people injected with either Gardasil, their ‘proprietary’ AAHS control solution (which contained the vaccine adjuvant), or saline solution (a real placebo–typically used for clinical trials of a new treatment) there were 463 new ‘medical conditions’ reported. All of these ‘conditions’ occurred after enrollment in Merck’s clinical trial. All of these conditions occurred in previously healthy young women. According to the information packet, these new medical conditions were “potentially indicative of a systematic autoimmune disorder.”
463 new medical conditions occurring in a population of 20,118 young healthy women–is that not unusual?
It is also important to note these new medical conditions are not listed in the ‘adverse reactions’ section of the information packet. They are enumerated near the end of a reasonably extensive prescribing information packet, where they could easily be overlooked.
Note that in the ‘adverse site reactions’ section, the vaccine, AAHS control, and saline groups are separate. Any reasonable person would ask why the saline placebo group and the AAHs control group were combined in the ‘new medical conditions’ section and the ‘common systemic’ reactions section.
Was it, perhaps, to lead people to believe the vaccine was just as safe as their ‘control solution’? After all, by combining these two ‘control’ groups, Merck was able to show the same percentage of ‘new medical conditions’ for both the vaccine and the control groups.
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