The Honorable Margaret A. Hamburg, M.D., Commissioner September 10, 2012
U. S. Food and Drug Administration (FDA) 10903 New Hampshire Ave. Silver Spring MD 20993-0002
Dear Dr. Hamburg:
In a public announcement, the FDA stated:
“Since the early development of Gardasil, FDA and the manufacturer (Merck and Co., Inc.) have known that after purification of the vaccine, small quantities of residual recombinant HPV L1-specific DNA fragments remain in the vaccine.” 1
This letter requests copies of the documents from the FDA showing:
1) The date when the FDA and the manufacturer first knew small quantities of residual recombinant HPV- L1-specific DNA fragments remain in the vaccine.
2) The physical condition of the HPV- L1-specific DNA fragments in the Gardasil® vaccine.
We are asking these questions because we have read the news report about Dr. Sin Hang Lee’s testimony delivered to the coronial court in New Zealand. During the inquest, Dr. Lee claimed to have discovered HPV L1 gene DNA fragments in the postmortem blood and spleen from a teenage girl who suffered a sudden unexpected death 6 months after the last dose of Gardasil® vaccination. The original pathologist reported he could not determine the cause of death in this case.
We have also read the advanced copy of a scientific report authored by Dr. Lee, being published in a peer-reviewed journal, entitled “Detection of human papillomavirus (HPV) L1 gene DNA possibly bound to particulate aluminum adjuvant in the HPV vaccine Gardasil®.”2 In this article, Dr. Lee stated:
“The detected HPV DNA was found to be firmly bound to the insoluble, proteinase-resistant fraction, presumably of amorphous aluminum hydroxyphosphate sulfate (AAHS) nanoparticles used as adjuvant. The clinical significance of these residual HPV DNA fragments bound to a particulate mineral-based adjuvant is uncertain after intramuscular injection, and requires further investigation for vaccination safety.”
Since the above-requested information is of paramount importance regarding the safety of HPV vaccines and consequently the protection of public health and safety, please know that this communication is being published as an open letter available on the internet to enhance public awareness. Copies are also being sent to the following interested parties:Darrell Issa, Chairman, Oversight and Government Reform Committee Representative Dan Burton (R-5-IN) Senator Barbara Mikulski (D-MD) Senator Charles Grassley (R-IA) Senator Tom Harkin (D-IA) Senator Orrin Hatch (R-UT)
We are looking forward to receiving the documents requested from the FDA so that our experts can analyze whether or not there is a potential link between the residual HPV L1 gene DNA fragments reported by the manufacturer and the various side effects observed in the vaccine recipients.Thank you for your assistance, Norma Erickson, President SaneVax Inc. Signed on behalf of the Board of Directors, SaneVax, Inc. Rosemary Mathis, Vice President Victim Support Freda Birrell, Secretary Linda Thompson, Treasurer Stephen Tunley, Australian Liaison