• Public Petitions FDA to Investigate Gardasil Vaccine Fraud

    The following open letter to FDA Commissioner, Dr. Scott Gottlieb, calling for immediate investigations into many facets of the clinical trials for Gardasil sponsored by Merck was emailed today. Dear Dr. Gottlieb: This open letter, written on behalf of medical consumers around the world, is an urgent request for you to investigate potential malfeasance perpetrated by Merck during their clinical trials of Gardasil, the human papillomavirus vaccine that the FDA approved in June 2006. A new book, The HPV Vaccine on Trial: Seeking Justice for a Generation Betrayed, by Holland, Rosenberg, and Iorio, outlines at least four areas requiring the FDA’s urgent attention.

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  • Public Petitions FDA to Investigate Gardasil Vaccine Fraud

    To FDA Commissioner, Dr. Scott Gottlieb,

    I strongly support this request for thorough investigations into many issues of the clinical trials for Gardasil sponsored by Merck.

    The system upon which clinical trials for vaccines is based is grossly inadequate regarding safety for vaccine recipients and should be considerably revised.

    Protocols for clinical trials which are compiled by the industry should be subjected to close scrutiny by unbiased experts (including statisticians) with no conflicts of interest whatsoever and who may approve or reject the protocols.

    Phase four for clinical trials which involves large groups in populations is totally inappropriate regarding registration of adverse events. New, reliable and effective systems for reporting of these must be implemented.

    The ethical aspects of all clinical trials which Merck and other vaccine manufacturers undertake, including those which take place in both developed and developing countries should be seriously addressed.

    Only trials for safety using completely inert placebos should be approved. Vaccines produced by Merck and other manufacturers where approval has been based on safety trials involving false placebos should be withdrawn.

    Merck’s use of false, active placebos in clinical safety trials for Gardasil is research fraud and should be regarded as a criminal act.

    Likewise, Merck’s failure to respect rights of consumers regarding informed consent should also be considered illegal.

    Merck’s exclusion criteria for the Gardasil clinical trials amounted to the vaccine being tested on handpicked groups which were not representative of the groups which were potential vaccine recipients.This issue should also be seriously investigated.

    Extrapolatlon of results of clinical trials from one age group to another should not have been undertaken. One reason is that it does not address the issues of the delicate hormonal balance and changes (for example regarding puberty) in the different age groups.

    Instead of imposing gigantic fines on Merck or other vaccine manufacturing companies the leader at the utmost top level should be made personally and legally responsible for research fraud and for other crimes committed within the company.

  • Public Petitions FDA to Investigate Gardasil Vaccine Fraud

    HI, REMEMBER THE PROMOTION OF THE THALIDOMIDE TABLET;THERE ARE OTHER SIMILIAR CASES OF THE INDIVIDUALS CONCERNED MAKING VAST PROFITS WITHOUT ANY MORALS ABOUT THE SUFFERING THEY CAUSE. IF THEY CAN DO IT THEN THEY CAN DO IT NOW WITHOUT ANY MISGIVINGS.