Gardasil Adverse Reaction Admissions by Merck and the FDA

June 11, 2009

To the Esteemed members of the Robert Koch Institute and Health Minister of Germany,

The attached documents have been compiled by the members of the International Coalition of Advocates for the People in regards to the safety and efficacy of the HPV vaccines; specifically for the HPV vaccine Gardasil® manufactured by Merck Pharmaceuticals.

Our concerns stem from an announcement from the United States FDA (Food and Drug Administration) dated 09 June 2009 citing an FDA approved revision of the labeling with strengthened warnings about adverse effect of the Gardasil® vaccine. It is because of this revision that we felt it our duty to inform you of the imminent changes to the Gardasil® package inserts.

A detail of our findings is presented in the document “Admissions by Merck and the FDA.”

We understand that you are very concerned about the health and wellness of all citizens of the European Union.  The members of the International Coalition of Advocates for the People share your concerns for your citizens and understand that the sustainability of providing adequate health care is paramount.

Hence, our urgency in presenting this new found information to the Institute and to the Health Minister.

Thank you for your patience and your continued efforts on behalf of the health and wellness of the citizens of the world.

Cynthia Janak
Research Journalist
Founder & President
International Coalition of Advocates for the People
http://www.i-c-a-p.org
cjanak@i-c-a-p.com

Leslie Botha
Researcher and Broadcast Journalist
Vice-President
International Coalition of Advocates for the People
lbotha@i-c-a-p.org

CC:

Minister of Health, Ursula Schmidt, Germany
Professor Claudia Hornberg, University of Bielefeld
Director: Univ. Prof. Dr. med. Hartmut Hengel
Dr. Gerd Antes
Prof. Dr. Ulrich Heininger
Prof. Dr.med. Dr. Friedrich Hofmann
Prof. Dr. Wolfgang Jilg
Prof. Dr. Rüdiger von Kries
Prof. Dr. Thomas Mertens
Prof. Dr. Martin Röllinghoff
Prof. Dr. Fred Zepp
Dr Ansgar Gerhardus, University of Bielefeld
Professor Martina Doeren Charite, Berlin
Professor Ferdinand M Gerlach, University of Frankfurt
Professor Michael M Kochen, University of Gottingen
Professor Petra Kolip, University of Bremen
Professor Wolf-Dieter Ludwig, Charite, Berlin
Professor Ingrid Muhlhauser, University of Hamburg
Professor Oliver Razum, University of Bielefeld
Professor Rolf Rosenbrock, Social Science Research Centre, Berlin
Professor Corinna Schach, University of Bremen
Professor Norbert Schmacke, University of Bremen
Professor Jurgen Windeler, Medical Advisory Service of German Social Health Insurance

__________________

Introduction

Reports of Health Concerns Following HPV Vaccination

Information Pertaining to Labeling Revision for Gardasil

June 09, 2009 Approval of Gardasil Changes to Package Insert

September 12, 2008 Approval Letter – Human Papillomavirus Quadrivalent (Types 6, 11, 16, 18) Vaccine, Recombinant

June 12, 2008 Approval Letter – Human Papillomavirus Quadrivalent (Types 6, 11, 16, 18) Vaccine, Recombinant

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.