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.