June 14, 2011
TROY, Mont.–(BUSINESS WIRE)–The SaneVax Team is pleased to announce multiple groups of concerned citizens worldwide including victims of adverse reactions post Gardasil vaccinations, families, physicians and public health advocates have started an open letter writing campaign addressed to two senior scientists in the U.S. government. These letters will also be sent to elected officials worldwide to inform them that medical consumers are aware of the apparent lack of compliance to regulations and guidelines.
In the interest of safe and effective vaccination practices, vaccine safety advocates are demanding the government comply with the law and immediately implement a reliable post-licensure monitoring program to validate the benefits of the HPV vaccine, being marketed as a cancer vaccine, indeed outweigh its risks to consumers. The letters have been posted on multiple websites for public viewing including: SaneVax, Inc.; www.gardasil-and-unexplained-deaths.com; DutyToInform.org; and others.
Dr. Mark Schiffman is a senior investigator at the National Cancer Institute (NCI) and the official medical monitor of the HPV vaccine clinical trial leading to the Food and Drug Administration (FDA) approval of the HPV vaccine for sales to prevent cervical cancer. The letter to him states medical consumers will hold him accountable for supplying the post-licensure monitoring survey results, specifically “to publish the HPV genotypes which are causing precancerous and cancerous cytologic changes in the women who have been immunized by the HPV vaccines, under the brand names of Gardasil and Cervarix.” Based on the VAERS Reports, a significant number of post-vaccinated women are now developing cervical precancerous and cancerous lesions.
The letter further stated that Dr. Schiffman must know that the HPV vaccines currently being marketed were approved by the FDA under the Fast Track Drug Development Programs, using “CIN 2/3, AIS, or worse by histology – with virology to determine the associated HPV type” as the surrogate endpoint in the evaluation of the efficacy of the vaccine to prevent cervical cancer.
According to “Guidance for Industry, Fast Track Drug Development Programs – Designation, Development, and Application Review”:
“Where an accelerated approval is based upon a surrogate endpoint or on an effect on a clinical endpoint other than survival or irreversible morbidity, postmarketing studies are ordinarily required ‘to verify and describe the drug’s clinical benefit and to resolve remaining uncertainty as to the relation of the surrogate endpoint upon which approval was based to clinical benefit, or the observed clinical benefit to ultimate outcome’ (57 FR 58942, December 11, 1992).”
“If no reliable data are forthcoming, you should recommend rescinding its approval until a reliable post-licensure monitoring system is instituted,” the letter stated.
A different letter to Dr. Markowitz, a senior scientific officer of the CDC, who is responsible for instituting a post-licensure monitoring program for HPV vaccines, requested that the CDC issue a directive to the vaccine manufacturers, vaccine distributors, state health departments and health care providers as follows:
“Any female patient who has been vaccinated with HPV vaccines who subsequently is diagnosed with Pap cytology results positive for cervical precancer or cancer, the electronic file diagnostic of the HPV genotype DNA sequence derived from the cervicovaginal cell suspension in the cytology sample is now reportable to the CDC.”
In the Final Report of a WHO meeting “Partnering for HPV Vaccination Introduction” dated 5th October, 2005, Dr. Markowitz on behalf of the CDC declared, “regardless of the outcome being measured, HPV typing would still be essential …. in the areas of implementation, surveillance development, and other aspects of impact monitoring”. That meeting was held before the FDA approved the sales of Gardasil in the U.S.
Multiple injured individuals, relatives and friends in the U. S. are sending letters to their elected congressional representatives in Washington, D.C., requesting their support to compel government employees to fulfill their duty as public servants and implement an effective, reliable post-licensure monitoring program for HPV vaccines’ efficacy as a drug for cervical cancer prevention.
S.A.N.E. Vax, Inc. is a non-profit organization established to promote safe, affordable, necessary, effective vaccines and vaccination practices.
1. Letter to Dr. Schiffman
2. Guidance for Industry, Fast Track Drug Development
3. Partnering for HPV Vaccination Introduction
4. Letter to Dr. Markowitz