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Article Originally Published On Sanevax.org
Malfeasance is when a public official violates the public trust by performing an act that is wrongful, legally unjustified, or contrary to law. Nonfeasance is the failure to act where there is a duty to act. Misfeasance is conduct that is lawful but inappropriate. Perhaps, when it comes to the recent approval of Gardasil 9 all of these apply.
10 December 2014: The FDA approved the use of a reportedly "new and improved" version of Gardasil, which will be marketed as Gardasil 9. According to the FDA approval letter, this action was taken without consultation with VRBPAC (the Vaccines and Related Biological Products Advisory Committee) which is responsible for reviewing and evaluating data concerning the safety, effectiveness, and appropriate use of vaccines and related biological products.
The FDA approval letter, signed by Marion Gruber, Director of Office of Vaccines Research and Review CBER, states the reason for bypassing the advice of VRBPAC writing:
"We did not refer your application to the Vaccines and Related Biological Products Advisory Committee because our review of information submitted in your BLA, including the clinical study design and trial results, did not raise concerns or controversial issues which would have benefited from an advisory committee discussion."
So, the Office of Vaccines Research and Review, Center for Biologics Evaluation and Research (CBER) committee took it upon themselves to decide there were "no concerns or controversial issues" regarding the approval of Gardasil 9?
This division of CBER decided there would be no benefit from "an advisory committee discussion"?
According to their own mission statement, the FDA is "responsible for protecting the public health by assuring the safety, efficacy and security of human and veterinary drugs, biological products, medical devices, our nation's food supply, cosmetics, and products that emit radiation."
The FDA, and all committees associated with the FDA, are public officials and therefore obliged to act in the public's best interest particularly when it comes to health and safety issues.
Is bypassing advisory committee discussions regarding Gardasil 9's potential safety and efficacy acting in the public's best interest, or is it malfeasance, nonfeasance and/or misfeasance?
Examine Some Gardasil 9 Facts
CBER decided there was no need for VRBPAC to review or evaluate any data concerning the safety, effectiveness, and appropriate use of Merck's proposed Gardasil 9 vaccine before making a decision to approve the nine-valent HPV vaccine. This move is particularly disturbing when one considers the worldwide controversy surrounding Gardasil's safety, effectiveness and appropriate use.
The proposed Gardasil 9 package insert and the current Gardasil package insert are a good place to start a critical examination. The table below lists the ingredients of both Gardasil and Gardasil 9. All differences from one HPV vaccine package insert to the next are highlighted.
|225 mcg||AAHS (aluminum adjuvant)||500 mcg|
|9.56 mcg||Sodium Chloride||9.56 mcg|
|.78 mcg||L-Histidine||.78 mcg|
|50 mcg||Polysorbate 80||50 mcg|
|35 mcg||Sodium Borate||35 mcg|
|<7 mcg||Yeast Protein||<7 mcg|
|20 mcg||HPV 6 L1 protein||30 mcg|
|40 mcg||HPV 11 L1 protein||40 mcg|
|40 mcg||HPV 16 L1 protein||60 mcg|
|20 mcg||HPV 18 L1 protein||40 mcg|
|HPV 31 L1 protein||20 mcg|
|HPV 33 L1 protein||20 mcg|
|HPV 45 L1 protein||20 mcg|
|HPV 52 L1 protein||20 mcg|
|HPV 58 L1 protein||20 mcg|
Take a look at the first line in the chart to the left. Aluminum is a known neurotoxin. A quick search of PubMed for "aluminum toxicity human" returns no less than 1652 peer-reviewed and published scientific papers on the subject. Why did Merck more than double the amount of aluminum adjuvant in Gardasil 9?
What long-term health consequences are associated with the injection of 1,500 mcg of aluminum over a period of less than a year via 3 doses of Gardasil 9?
Does this risk increase if Gardasil 9 is received at the same time as another vaccine containing an aluminum adjuvant? If so, how much?
Surely the members of CBER are aware there are potential health risks resulting from aluminum exposure. Did they discuss these risks before making a decision?
Why did Merck increase the amount of HPV L1 protein for 3 of the HPV types already contained in the first version of Gardasil and not for the 4th type? Why do the amounts of these increases vary so much from one HPV type to another?
Are there any potential health risks associated with increasing the total amount of antigen (HPV L1 protein) from 120 mcg in Gardasil to 270 mcg in Gardasil 9?
There seems to be no public record of the CBER meeting, so the general public – including medical professionals who will be expected to administer this new HPV vaccine to their patients may never know whether or not these subjects were even discussed.
Bombshells From The Gardasil 9 Package Insert
The potential risks discussed above pale in comparison to some of the bombs dropped in the rest of the Gardasil 9 package insert. Any medical professional who reads the entire package insert and still recommends the use of either Gardasil, or Gardasil 9 does not care about the health and well-being of their patients.
Bombshell #1: Serious Adverse Events
According to the FDA a serious adverse event must fit one of the following criteria: death, life- threatening, hospitalization, disability or permanent damage, congenital abnormality/birth defect, or the requirement to intervene to prevent permanent impairment.