As mentioned above, this concern was expressed regarding one group (#13 in the Merck study group) who were shown to have abnormally high risk factors and which was believed to be attributed to these results.
Despite this, the overwhelming body of data ultimately resulted in the FDA's approval of Gardasil later that same year. I'm not clear as to why you believe that document should be updated or revised. Their concerns were what they were however sufficient information was provided to the FDA to account for the results in that particular group. The FDAs ultimate decision should speak for itself in addition to the fact that since 2006 the FDA has gone on to approve Gardasil for the prevention of precancerous and cancerous lesions of the vagina, vulva and anus.
To continue to focus on one isolated group in a study from over five years ago whose outcomes were sufficiently explained to the FDA such that they ultimately approved the vaccine and disregard the FDAs approval to also expand its use since then is obviously for one purpose only - to persuade people against the use of the vaccine
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As mentioned above, this concern was expressed regarding one group (#13 in the Merck study group) who were shown to have abnormally high risk factors and which was believed to be attributed to these results.
September 9, 2011 - 6:41amDespite this, the overwhelming body of data ultimately resulted in the FDA's approval of Gardasil later that same year. I'm not clear as to why you believe that document should be updated or revised. Their concerns were what they were however sufficient information was provided to the FDA to account for the results in that particular group. The FDAs ultimate decision should speak for itself in addition to the fact that since 2006 the FDA has gone on to approve Gardasil for the prevention of precancerous and cancerous lesions of the vagina, vulva and anus.
To continue to focus on one isolated group in a study from over five years ago whose outcomes were sufficiently explained to the FDA such that they ultimately approved the vaccine and disregard the FDAs approval to also expand its use since then is obviously for one purpose only - to persuade people against the use of the vaccine
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