Hi All
Ana, this is not to beat you up but just to share what I know about this. Given your situation, it is no suprise that you would be wary of vaccines and take the information you found exactly as you have. It is an unfortunate fact of life that people (including researchers) screw with data to get the results that fit with their opinions or the axe they have to grind. Here comes my perspective on the data ...
The submission that Ms Janak quotes is a submission to the FDA from Dr Lee to register a test for
HPV. In order to persuade the FDA, he argued that his test was needed because women (they were looking at cervical pre-cancerous lesions caused by
HPV) who already had active (I think)
HPV infection had the vaccine, then their chances of developing grade 2/3 CIN or worse were increased by 44% compared with women who didn't. This is figure that Ms Janak took and didn't research. If she had, she would have discovered that Dr Lee misrepresented the figure. I didn't know about the stoush between Dr Lee and the FDA though - thanks Charm.
This number was taken from a substudy of the original
HPV vaccination submission and specifically from substudy 013 which had approximately 160 women in each group (received vaccine vs received placebo). They found that approximately 35 women went on to develop cancer whilst only approximately 19 in the placebo group developed cancer.
HOWEVER, in the same submission, it was explained that the two groups of women were not similar and the group who received the vaccine also had a higher incidence of known risk factors including more sexually transmitted infections, higher smoking history and one other risk factor which I can't remember right now. One of the other substudies (substudy of 015) which was over twice the size of 013 found no such result and this substudy also didnt have the discrepancies in the baseline data. When the data were pooled there was no evidence that the HPV vaccine caused a higher incidence of cancer in women who already had pre-cancerous dysplasias. IN THE SAME DOCUMENT that Dr Lee and subsequently Ms Janak misquoted, the FDA went on to reject the 44% increase in cancer finding, suggesting it was more likely a function of small study size and disparate comparison groups rather than any real difference. I will try and find the original FDA document and for people to read but it might take a while as the submission was back in 2006 and my computer at home won't let me into as many sites as my computer at work will.
Disclaimer: My figures are approximate only as I am going on my own recollection of the figures.
Maybe Brian or DavidCPA can access the document which I think was minutes of the FDA meeting where Gardasil was submitted for registration? It was definitely 2006
Off to see if I saved the document somewhere safe - back soon
