Pharmalot October 25, 2010 by Ed Silverman Taking a direct approach with the FDA is all the rage these days. For instance, aggrieved investors recently created an online petition to implore the FDA to investigate staffers for their input into a recent panel meeting for the Arena Pharmaceutical diet pill (see this). And now several […]
Request that the FDA rescind its approval for Gardasil™ as a vaccine to prevent cervical cancer or to prevent genotype-specific human papillomavirus (HPV) infection due to use of an inappropriate primary endpoint and unreliable HPV genotyping methods for efficacy evaluation
SANE Vax Inc. October 19, 2010 The Honorable Margaret A. Hamburg, M.D., Commissioner U. S. Food and Drug Administration (FDA) 10903 New Hampshire Ave. Silver Spring MD 20993-0002 Subject: Request that the FDA rescind its approval for Gardasil™ as a vaccine to prevent cervical cancer or to prevent genotype-specific human papillomavirus (HPV) infection due […]
10.21.10 VAERS Data
VAERS Since the beginning of October there have been 129 new reports, including 2 new death reports. HPV and HPV4 19618 HPV2 483 Total 20101 Died HPV and HPV4 80 HPV2 4 Total 84 New death reports. VAERS ID: 397437 Vaccinated: 0000-00-00 Age: Onset: 0000-00-00 Gender: Female Submitted: 2010-09-02 Location: New York Entered: 2010-09-03, Days […]
Irish Medicines Board Update on National Monitoring Experience with Gardasil
Irish Medicines Board 21st October 2010 The HSE human papillomavirus (HPV) schools immunisation programme commenced in May 2010 and it is estimated that up to 17,000 doses of Gardasil have been administered up to the end of September 2010. The Irish Medicines Board has received a total of 34 reports of adverse events associated with […]
U.S. Court of Federal Claims – Damages decision based on stipulation; HPV/Menactra and Multiple Sclerosis
United States Court of Federal Claims DECISION AWARDING DAMAGES1 On October 4, 2010, the parties filed the attached stipulation, in which they agreed to settle this case and described the settlement terms. Petitioner alleged that she suffered from paralysis and right-sided numbness which was eventually diagnosed as multiple sclerosis following her meningitis and human papillomavirus […]
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