S.A.N.E. Vax calls for temporary withdrawal of Merck & Co’s Gardasil claiming inappropriate endpoint and unreliable HPV genotyping methods used

thepharmaletter

October 27, 2010

In a letter addressed to US Food and Drug Administration Commissioner Margaret Hamburg, Norma Erickson, president of the not-for-profit S.A.N.E. Vax group, stated her research team has revealed the fact that, in November 2001, the VRBPAC (Vaccines and Related Biological Products Advisory Committee) mistakenly allowed Merck & Co (NYSE: MRK) to use “CIN 2/3, AIS, or cervical cancer; ie, CIN 2/3 or worse by histology – with virology to determine the associated HPV type – as the primary endpoint in the evaluation of its vaccine [Gardasil] to prevent cervical cancer.”

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This has nothing to do with “enjoying the article” – but is more about our press release and demand that Gardasil be temporarily be taken off the market is making its way around the world in credible industry publications.

PG

Author: Leslie Carol Botha

Author, publisher, radio talk show host and internationally recognized expert on women's hormone cycles. Social/political activist on Gardasil the HPV vaccine for adolescent girls. Co-author of "Understanding Your Mood, Mind and Hormone Cycle." Honorary advisory board member for the Foundation for the Study of Cycles and member of the Society for Menstrual Cycle Research.