By: Norma Erickson
22 October 2010
On October 19, SaneVax, Inc. sent a formal letter to the FDA Commissioner requesting they rescind approval for Gardasil. Our team’s reasoning is entirely based on scientific facts described in detail in the attached letter to Dr. Hamburg. A copy of this was sent to every current member of the Vaccines and Related Biological Products Advisory Committee (VRBPAC). The SaneVax team wanted to make sure those of you who have been involved in the battle against Gardasil were among the first to have an opportunity to read the information.
We also sent a second letter to all members of VRBPAC regarding the upcoming hearing on the proposed expansion of Gardasil’s use as a preventive for anal cancer. Our contention is since Gardasil did not use a valid endpoint and reliable HPV genotyping method during the clinical trials that led to the vaccine’s original FDA approval, that its use cannot be expanded until such time as valid studies are completed.
Copies of both letters were sent to all of the parties listed above and to the chair of the committee charged with evaluating HPV test approvals in the United States. Our primary goal is to make absolutely certain that the FDA knows we are watching their every move and will not tolerate anything less than completely valid scientific methods when conducting clinical trials on products that are supposed to promote and protect the health of the public.
Ideally, the FDA Commissioner will listen to our argument and rescind Gardasil’s approval until such time as scientifically accurate studies are completed. We shall see.