FDA – September 9, 2009: Vaccines and Related Biological Products Advisory Committee briefing information

An independent evaluation of the briefing documents

Renew America

September 11, 2009

by Cynthia Janak

The first document I am going to reference is “Male indication for Gardasil” sponsored by Merck Research Laboratories.

The duration of this study is noted on page 6 of this document.

Sera were collected for immunogenicity at screening and at months 7, 24 and 36. Safety assessments were obtained at each visit and every 3 months after Month 6 by phone or email.

My focus is going to be on the safety section of this document which starts on page 11.

First, I am going to show you when these assessments were carried out.

Safety Assessments were performed at each vaccination visit and every 3 months post-dose 3.

All subjects were given a Vaccine Report Card (VRC) to record:

  • Oral temperatures out to 4 days

  • Injection-site adverse events (AE) out to 14 days

  • Systemic AE’s out to 14 days

No routine laboratory tests were conducted within the context of the study.

Let us study these comments.

First you see that the study ran for 36 months. That in itself seems reasonable but what red flagged me here is that after the third immunization these people were contacted by phone or email. How can these individuals assess what could be signs of serious adverse events? They are not medical professionals and would not know what to look for. Therefore, the only real data available are the safety assessments that were performed at each vaccination visit. That leaves us with only 6 months of professionally evaluated data.

Next, we are going to look at the data that concerns the adverse events that were reported between the Gardasil group and the Alum placebo group. This starts at the bottom of page 11 of this document.

Adverse Events

The summary analysis of AE’s was unremarkable. Similar percentages of subjects in Gardasil group compared to the placebo group experienced any AE during the study (69.2% vs. 64.2%, respectively), discontinued participation in the study due to an AE (0.3% vs. 0.7%, respectively), or reported a new medical condition (24.2% vs. 22.8%, respectively).

What I find laughable is the fact that the reviewer states, “The summary analysis of AE’s was unremarkable. This reviewer does not see any concern over the fact that almost 70% of the participants of the Gardasil group had an adverse event of some type. I do not understand how 69.2% is unremarkable.

Let me use this analogy. If 69.2% of people who ate a certain brand of peanut butter got sick that peanut butter would be removed from the grocery store shelf immediately.

Let us go on to the section called “new medical condition.” This reviewer sees no issue with the fact that almost 25% of the participants in the Gardasil group acquired a “new medical condition” during this study. They also did not feel it important enough to list what those new medical conditions were. Interesting.



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.