[quote]This demonstrated a limitation of the evaluation of small subgroups, where subgroups might have imbalances in baseline demographic characteristics. In this case, it appeared that subjects in this subgroup of study 013 who received Gardasil� might have had enhanced risk factors for development of CIN 2/3 or worse compared to placebo recipients. In study 015, the applicant conducted a subgroup primary efficacy analyses for HPV 16/18. Here, the evaluation of this subgroup did not raise a concern about enhancement of cervical disease due to HPV: [/quote]

I'm back!

I got some numbers wrong - it was 31 ladies who developed CIN 2/3 or worse not 35 in a group of 156 vs placebo group of 137. There are likely other numerical errors too but the sentiment is correct. They also developed pre-cancerous lesions - not cancer as I reported in the last post - sorry.

The quote above comes from the original document that Dr Lee and Ms Janak misquoted. The figures they misrepresent are in table 17 page 13.

http://www.fda.gov/ohrms/dockets/ac/06/briefing/2006-4222B3.pdf

I am not sure if I did the link right but you can go to the FDA website and just enter 4222B3 which is the number of the document and it pops right up.