Reply #7: Gardasil: "FDA Approval Not Based On Actual Cancer Prevention"

[WillYourVoteBCounted]

Gardasil "may" prevent infection with certain types of HPV viruses that are
"associated with" cervical cancer.


Cancer Not Measured

How effective is Gardasil in decreasing the incidence of cervical cancer? 100%? 50%? No one really knows because this question has not yet been answered. As of today, the Gardasil vaccine has never been proven to decrease the actual incidence of cervical cancer. In the studies that led to the vaccine’s approval, the incidence of cervical cancer was not measured. Instead CIN (cervical intraepithelial neoplasia) 2/3 and AIS (adenocarcinoma in situ) were used as the surrogate markers for prevention of cervical cancer because according to the vaccine’s insert “CIN 2/3 and AIS are the immediate and necessary precursors of squamous cell carcinoma and adenocarcinoma of the cervix, respectively.” While this is true it is also true that CIN 2/3 and AIS usually do not lead to cancer. For example, according to published data, CIN2 only leads to invasive carcinoma 5% of the time and CIN3 only leads to invasive carcinoma 12% of the time.(1)

HPV Alone Insufficient to Cause Cancer

In addition, Gardasil is targeted against Human Papilloma Virus (HPV) (types 6, 11, 16, and 18).

However, during discussions at the FDA it was admitted that HPV alone is insufficient to cause cancer.

Dr. Elizabeth Unger of the Centers for Disease Control stated, “So it is believed that infection alone is insufficient to cause cancer, and additional factors are required for neoplasia. There are certainly lots of questions about HPV infection…”(2) This point is echoed in the medical textbook Cancer: Principles & Practice of Oncology whose editors include Dr. Vincent DeVita, Jr. who was President of the National Cancer Institute and Dr. Steven Rosenberg, Chief of Surgery at the National Cancer Institute. According to this text, “HPV infection is not sufficient for cervical carcinogenesis…”(3)

More at Cancer Monthly here:
http://www.cancermonthly.com/blog/2007/12/gardasil-cervical-cancer-vaccine.html