LilyL21

Wow, I was reading about the positibility that Gardasil increases the chance of CIN2/3 in women who are HPV postive, and I was FREAKED OUT! I just received my last dose of the vaccine yesterday!!!!!

I found the study, read it, and it actually made me feel much better. So here's my executive summary:

First, the link to FDA (government NOT commercial) website with the study results:
http://www.fda.gov/ohrms/dockets/ac/06/briefing/2006-4222B3.pdf

Start on page 13: "Concerns Regarding Primary Endpoint Analyses among Subgroups."

Okay, so some of the women in the studies were "seropostive" aka they had HPV antibodies in their blood and some were "PCR positive" aka a positive HPV DNA test. And some were postive for both.

For women who were both PCR positive and seropostive in study 013: the placebo group 7.7% developed CIN 2/3 compared with 11.1% in the Gardasil group. That's a bit concerning!

But then they talk about how this group of women was a "subgroup" of the study and so they hadn't made it demographically even. For example, 6.5% of the Gardasil group had previously had an HGSIL result from a pap, while only 3.7% in the placebo group did. And in the Gardasil group there were more smokers and more women with other STDs.

In study 015, the women in the PCR/seropostive subgroup were more demographically even, and the placebo group had a CIN 2/3 rate of 6.3% and in the Gardasil group it was 6.0%.

So basically they conclude that this issue warrants "more study" but it appears that study 013 was probably just messed up demographically.