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.
Just goes to show that everything must be taken in "context". So often people just jump to conclusions and don't read or don't understand the data as you obviously DO Lily. Then they run around talking about how you can get cancer from the vaccine. Fact is there is absolutely no HPV DNA in the vaccine at all. Unlike some vaccines which are produced by attenuating (weakening) the organism, this is not the case with Gardasil. It is made from VLP's, virus like particles so it cannot convey the HPV DNA to anyone only work to stimulate an antibody response.
I really think that there is a huge issue with credibility. If you read someone's blog and take it as law, that only perpetuates fear and conspiracy. If you take the time to do the research, learn about the issue and then create a stance, I think the argument becomes mature and credible. Particularly regarding health, we need to be cautious about the potential panic we're imposing upon someone who is just beginning to learn about these issues. I think it is irresponsible to haphazardly post without validating that the information is accurate.
Thanks Lily for positing and Dragonfly for your feedback as well!
You know, when I did some googling and trying to find answers, I came across several papers basically saying that Gardasil increased your risk of CIN 2/3 if you already had HPV. There is a particularly bad one from "Judicial Watch." (After reading more stuff from their site, I have come to the conclusion that thye think everything is governemnt conspiracy.) Their report is full of these anecdotal stories of girls developing huge outbreaks of warts and others suddenly dying after getting the vaccine.
But when it talks about the increase of in CIN 2/3 cases, it cites back to that FDA document I was talking about. It also doesn't mention that the "adverse reaction" events were about the same as in the placebo group for everything except injection site reaction.
I found the same thing too. It is hard when you start out to know what to believe and what not to believe. When I first got this information, I bet I spent over 20 hours over a two or three week period just researching before I even posted on this board. In the end, it is you guys who I take the most value from, not studies done by slanted bystanders who haven't been through this or treated it.
It is so interesting to see how many people have an opinion on something that they've never encountered.
Lily you did a good job, I am actually going to ask my doctor whether I should take Gardasil. I am turning 26 in this Oct, so it is like the last chance to catch up.
Totally get the vaccine. With the exception of the one group discussed in that study, everything I've seen seems to show positive results for the vaccine in HPV positive women. This applies to both clearence rates and the rates of developign dysplasia.
Usually the differences are very small, even fractions of percentage points. The studies usually conclude that there is no difference. However, it seems to me that since the vaccinated group pretty much always comes out slightly ahead, the vaccine would be a good thing!
I had found an article that is a little bit old, but it says that retroactive shots may actually be a good thing. While it is against site policy post a link to the site, I will provide the article title and publication date so that you may search for it yourselves. If I am reading it properly, it has some encouraging news to offer.
"Sustained Efficacy Of Gardasil Against Early Cervical Lesions, Precancerous Vulvar And Vaginal Lesions, And Genital Warts In Large Phase III Studies"
published on March 14, 2008
