How did Gardasil pass FDA review?

May 21, 12:22 PMVaccines ExaminerNorma Erickson

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.


Comment from a reader on the site:

Hi Norma, I am medical journalist from Austria. Your raise very good and interesting questions. The main point is: Why did the FDA allow such an incredible ridiculous study-design? If they would have forced Merck to use a saline-placebo group for control – we now could tell all about the side effects of this vaccine. With more than 20000 girls and women in the Gardasil-Studies, we even knew a lot about some rare side effects with possible autoimmune etiology.

But we did not have this control group. Instead we did test Gardasil’s novel aluminum adjuvants with HPV-antigens against Gardasil’s novel aluminum-adjuvants without the antigens.

What we can say now: The antigen is not the problem.
But every serious scientist knew that before: The possible safety-problem lies in the adjuvant not in the antigen.


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.