Tag: VRBPAC

The FDA Approves a New HPV Vaccine Containing Over Twice as Much Aluminum As its Predecessor#HPV#iBelieve#halftime

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You can expect that the FDA has received a lot of correspondence from parents, advocates, physicians, researchers and so forth in regards to the significant injuries following the Gardasil and Cervarix vaccines.  It is stunning that they have once again approved this vaccine and now with even higher amounts of aluminum.  

A clear message that they do not have your best interests in mind.

by Christina England

 According to recent reports, the FDA has approved yet another HPV vaccine, despite documented safety issues and the new vaccine containing an exceptionally high level of aluminum, a known neurotoxin.

Until now, only two vaccines have been manufactured to protect men and women against human papillomavirus (HPV), a virus believed to be the leading cause of cervical cancer: Cervarix, which is believed to protect against strains 16 and 18 of the virus, and Gardasil, which is believed to protect against strains 6, 11, 16 and 18…

Many are skeptical and have begun to question whether or not this vaccine is yet another unsafe, fast-tracked vaccine.

Parents Question Whether or Not They Can Really Trust the FDA’s Claims…

Continue to the Article Here

www.vactruth.com

Related Articles:

My Daughters Life Altering Changes after Gardasil

Warning Gardasil Injuries can have a Permanent Impact

My Gardasil Survivor

HPV Vaccines: SaneVax Message to Columbia

FDA Approved Gardasil 9: Malfeasance or Stupidity

What if HPV does NOT cause cervical cancer?#HPV#HearThisWell#cdcwhistleblower

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 SaneVax-FeaturedBy Norma Erickson and Peter H. Duesberg, PhD

The title of a paper recently published by McCormack et al in Molecular Cytogenetics says it all, ”Individual karyotypes at the origins of cervical carcinomas.” If the findings in this paper are true, a vaccine against human papillomavirus (HPV) is extremely unlikely to protect against cervical cancer.

According to this paper neither genetic predisposition nor HPV infections are necessary for the development of cervical cancer. All cervical cancer cells investigated during the course of this study contained  new abnormal karyotypes. The clonality (genetic makeup) of these new abnormal karyotypes indicates the cervical cancers originated with these karyotypes – NOT from a virus.

In order to grasp the potential significance of these statements, one must have a basic understanding of karyotypes. Most living things have chromosomes, or units of genetic information, in their cells.  The human-karyogramnumber and appearance of chromosomes varies from one species to another. A karyotype is the number, size, and shape of chromosomes in any given organism.

See the graphic representation of the human karyotype to the right. Every human has 23 pairs of chromosomes (46 total) as illustrated, with the last pair on the bottom right determining the sex of any particular human. Any different number would indicate a different species. For example, apes have 48 chromosomes and kangaroos 20. The number, size and shape of the chromosomes in any given cell reveals the species of origin for that cell.

Cancer-specific karyotypes explained

All cancers have individual clonal (cells descended from and genetically identical to the parent cell) karyotypes (number, size and shape of chromosomes) and thus phenotypes (expressed physical traits).  No two cancers are the same.  See the karyotype arrays in the paper named above and referenced at the end of this article.

The karyotype determines the phenotype via thousands of messenger RNAs (about a thousand per chromosome), which in turn make thousands of proteins – at concentrations (copy numbers) that are cancer karyotype-specific – all cancer cells are individually very different from normal cells. In this respect, cancer cells resemble a new cellular species existing within the human body, much like a parasite.

The genes and proteins within cancer cells are expressed at very abnormal concentrations when compared to the normal cells surrounding them. However, since all genes and proteins expressed within cancer cells originated from human cells, cancers are not immunogenic (able to produce an immune response) – despite their huge biological differences from surrounding normal cells.  This is the reason the immune system cannot “see” cancers.

Since the new carcinoma karyotypes express thousands of normal genes abnormally they generate numerous new cancer-specific phenotypes that correlate one-to-one with the new karyotypes of cancer cells.  Cervical cancer cells are one example.

Think about Down syndrome as a model; one extra small 21 chromosome changes a lot.  Cancers typically have 60-70 chromosome variations compared the 46 +1 of Down syndrome.

The Human Papillomavirus (HPV) Causes Cervical Cancer Hypothesis

This hypothesis states that HPV encodes proteins which cause cancers as the virus replicates.  Having common transforming proteins, all cervical carcinomas would be more or less the same if this were accurate.  Since viral proteins are foreign to humans, viruses, virus-infected cells and possibly virus-transformed tumor cells would inevitably be immunogenic and as such eliminated by the host’s immune system within weeks to months after infection.

This is the reason why HPV-induced warts are eliminated by the immune system within weeks to months after infection.

This hypothesis raises four questions:

  1. Why would only 1 in 10,000 HPV-infected women develop cervical cancer?
  2. Why would cervical cancers only develop 20 to 50 years after infection? – In other words, why would the virus not cause cancers when it is biochemically active and causing warts, namely before it is neutralized by natural anti-viral immunity?
  3. Why are cervical carcinomas individually very distinct from each other in terms of malignancy, drug-resistance, cell histology, as originally described by Papanicolaou et al. in Science in 1952, although they are presumably caused by the same viral proteins?
  4. Why are cervical carcinomas that are presumably generated by Human Papillomavirus proteins not immunogenic and thus not eliminated by natural antibodies?

Despite over 25 years of research on the HPV causes cancer hypothesis, there are no direct answers to these questions.

Instead poorly defined “co-factors” are mentioned as “collaborators” of HPV in the causation of carcinomas.  Poorly defined cellular mutations are mentioned as the causes of the cervical carcinomas of HPV-negative women.

Moreover, about 30% of cervical cancers are virus-free.   In these cases the virus couldn’t even theoretically be responsible for the cancer.

The Karyotypic Speciation Theory of Cervical Cancer Development

The McCormack et al. study, ”Individual karyotypes at the origins of cervical carcinomas” advances the theory that carcinogenesis is a form of speciation (See Duesberg et al., “Is carcinogenesis a form of speciation?” Cell Cycle 2011).

According to this theory karyotypic evolutions generate new cancer species from normal cells after exposure to carcinogens (e.g. cigarette smoke or X-rays) or after spontaneous mitotic accidents. The common function of carcinogens is the induction of aneuploidy (chromosomal disruption, either gains or losses).  By unbalancing thousands of genes aneuploidy automatically destabilizes the normal human cell karyotype and thus catalyzes random karyotypic variations.  Selections of variants with proliferative phenotypes form nonclonal pre-neoplastic hyperplasias (enhanced growth of non-neoplastic cells in a tissue or an organ) with persistently varying karyotypes. Very rare karyotypic variations form autonomous (capable of replicating without influence from surrounding host cells) new cancer species with individual clonal karyotypes.  Cancer karyotypes are stabilized within narrow margins of variation by clonal selections for cancer-specific autonomy.  Since this mechanism is very inefficient, it predicts long latent periods from carcinogen exposures to cancers with individual clonal cancer karyotypes.

In agreement with this theory, the authors discovered new, cancer-specific karyotypes and phenotypes in all cervical carcinomas tested so far – both in HPV-DNA-positive and negative carcinomas.

Furthermore, they discovered the individual karyotypes of each carcinoma correspond 1 to 1 to their individual phenotypes (e.g. invasiveness and resistance to chemotherapeutic drugs).  This is proof-of-principle that these karyotypes determine the phenotypes of cancers – rather than the defective and latent Papilloma-virus DNAs.

According to the karyotypic speciation theory, the defective viral DNAs of “HPV DNA-positive” carcinomas are functionally irrelevant, because they are not expressing any viral proteins.  Instead they are non-immunogenic fossils of long past Papilloma-virus infections.  As such they are no matches for the thousands of cellular genes that are abnormally expressed in cervical carcinomas.

Karyotypic speciation theory explains paradoxes presented by the HPV causes cancer hypothesis

Why would only 1 in 10,000 HPV-infected women develop cervical cancer? 

According to the karyotypic carcinoma theory this discrepancy is the result of the facts that HPV infection and carcinogenesis are two entirely independent events:

  • No specific correlation exists between HPV and cervical carcinoma. HPV is very common, about 70 to 80% endemic in the American population.  The rest of the population is HPV-free.  The virus is typically sexually transmitted at young age.  Since cervical carcinomas occur in both HPV-positive and HPV-negative females, there is no specific correlative evidence that HPV plays any role in causing cervical cancer.
  • There is also no specific functional correlation between HPV-infection and carcinogenesis. As shown from the clonal karyotypes of cervical cancers, cancers originate from a major rearrangement of the karyotypes of normal cells.  Since this is true for cervical carcinomas of HPV-positive and of HPV-negative females – and is indeed true for all cancers – there is no functional evidence that HPV plays a role in the development of carcinomas.  This conclusion is consistent with the fact that carcinomas with new clonal karyotypes arise only 20 to 50 years (!) after infection by HPV, which we discuss next.

Thus there is neither a specific correlation between the presence and/or the functions; or lack of functions of HPV and carcinogenesis.

Why would cervical cancers only develop 20 to 50 years after HPV infection?

The karyotypic cancer theory sheds light on the presumed long latent periods from HPV infection to cancer. This huge latent period suggests evidence of two entirely unrelated events:

  • Infection with a sexually transmitted, benign Human Papillomavirus at young age, and
  • A cervical cancer diagnosis – 90% of which occur over the age of 50

The presumed long latent period could be a result of the low probability of forming a new autonomous cancer species from a normal somatic cell by random karyotypic rearrangements.  The evolution of a new individual species of cells (cervical cancer cells) with the ability to reproduce independent of influence from surrounding human cells by random karyotypic variations of precursor cells takes time.

The very low probability of evolving a new autonomous cancer species by random karyotypic evolution explains not only the long and unpredictable time intervals between HPV infection (if it occurs) and cervical carcinomas, but aso the classical age bias of all cancers.  The age bias of cancer says that over 90% of all cancers only occur at ages over 50 years.

The authors concluded the chronological discrepancies between HPV infection and carcinogenesis exclude a direct mechanism of action connecting viral infection and the development of cancer.   Instead the time-dependent evolution of a new cancer-specific karyotype supports the karyotypic theory of the origin of cervical carcinomas.

Why do cervical carcinomas have individual karyotypes and phenotypes – rather than common phenotypes as predicted by the virus hyothesis?

The probability of forming the karyotype of a new autonomous cancer-species by random karyotype variations is very low and thus unlikely to ever generate the same new species twice – much again as in conventional speciation.  Thus all cancers caused by karyotypic speciation will have individual, if sometimes similar phenotypes.

Why are presumably viral cervical carcinomas not immunogenic and thus not eliminated by natural antibodies?

The karyotypic speciation theory explains why presumably viral cervical carcinomas are not immunogenic and are thus able to grow in HPV-DNA-positive people, which contain anti-HPV antibodies produced as a result of prior infection(s) by the virus.

According to the karyotypic cancer theory, carcinomas are generated de novo from cellular chromosomes, genes and proteins, which are not immunogenic in the host of origin (just like all other cancers).  By contrast, hypothetical cancer cells generated by viral proteins would be immediately eliminated by antiviral immunity.

Since cervical carcinomas have clonal carcinoma-specific karyotypes, we know they were generated via chromosomal rearrangements of thousands of normal cellular genes, which are not immunogenic.

According to the authors, fragments of inert HPV DNA found in 70 to 80% of cervical cancers (and in 70 to 80% of all women in the US!) are left-overs of by-gone infections or warts that occurred 20-50 years prior to carcinogenesis.  Infections and resultant symptoms were eliminated by natural anti-HPV antibodies.

Should the Karyotypic Speciation Theory be proven correct, HPV vaccines could not possibly reduce the incidence of cervical cancer – or any other type of cancer for that matter.

What do we do now?

Until such time as scientists can verify or disprove the Karyotypic Speciation Theory of cervical cancer development, medical comsumers must proceed with caution.

This is a scientific debate which cannot be ignored. Public health authorities and medical professionals must apply the precautionary principal by suspending the use of HPV vaccines and supporting the already proven, safe and effective method of controlling cervical cancer – Pap screening.

It is this method which, after its introduction by George Papanicolaou et al. in Science in 1952, reduced the incidence of cervical cancer in the US from the most common of the 10 most common cancers of women to one that no longer belongs to this list.

Moreover, this proven test for cervical carcinomas, termed Pap screen after Papanicolaou, costs only a small fraction of the $300-500 for the Gardasil and Cervarix vaccines and has NO serious adverse effects.

Immediate independent studies must be conducted to discover which of the theories discussed above is accurate. If HPV does not cause cancer – HPV vaccines are useless.

If HPV vaccines are useless, it is certainly not worth submitting yourself (or your loved ones) to the 2.3 to 2.5% risk of serious adverse reactions AND the 2.4 to 3.3% risk of developing a new medical condition potentially indicative of autoimmune disorders experienced by Merck’s Gardasil 9 clinical trial participants.

ALL RISK AND NO BENEFIT IS NOT A WISE MEDICAL CHOICE UNDER ANY CIRCUMSTANCES.

 

References:

This article in it’s entirety, is compliments of www.SaneVax.org

My daughter’s life altering changes after Gardasil#cdcwhistleblower#Family#iBelieve

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By Shanna DeJaynes, Okay Oklahoma

It breaks my heart to know my daughter had none of these medical issues until after she received those two shots of Gardasil. As a mother, I struggle daily with regret. I allowed my daughter to get this vaccine thinking I was doing the right thing. As it turned out, nothing was further from the truth.

My daughter lives a Gardasil nightmare.  Our family has suffered along with her for almost three years. I refuse to be silent any longer. I share my daughter’s story as a warning to others – Gardasil is not safe for everyone – please, don’t make the same mistake we did.

At 13 years old my daughter, Breanna DeJaynes, was involved in volleyball, basketball and cheerleading at school. She was very outgoing and not shy to make new friends at all. She was a good student, hardly ever missed school and got good grades. She was on the honor roll for several years in a row. Breanna was very active both in and out of school. I could hardly keep her inside; when she wasn’t out practicing or in the classroom, she was with her friends. In short, Breanna was a healthy, happy, all-American girl before Gardasil.

She received her first HPV vaccine injection in April of 2011. Within a couple of days she started having some mild symptoms like dizziness, headaches, cramps in both her legs and arms, passing out, getting over heated easily and complaining that the arm she had the injection in was achy at times.

Every time something happened we would take her to the doctor. If it happened at school they would call 911 and have EMS come and rush her to the hospital (it was school policy to call 911 whenever something happened at a school-sponsored event).

We were always told she was just overdoing it with her sports, she had just hyperventilated, or that she had stood up too fast, or she had taken too hot a bath or shower, got overheated, wasn’t drinking enough water, was dehydrated and so on. We were told everything under the sun. The possibility that her new symptoms could be related to the HPV vaccine never crossed my mind at the time.

As the weeks passed her symptoms continued to get worse. She received her second Gardasil injection in June or July of 2011 and things got worse than before. Her headaches got so severe she couldn’t even stand to be in light, it would make her nauseous. The headaches were always in the same spot on her head in the frontal lobe. Her leg and arm cramps got worse, passing out continued, then she started having seizures both with and without memory loss, at times forgetting her friends, family and so on.

She suddenly couldn’t handle being in large crowds, it would make her so nervous she would start to cry hysterically and hide behind whoever or whatever she could. When she had a seizure it wiped her out to the point where she couldn’t walk or even talk sometimes due to being so confused and disoriented, not knowing where she was most of the time.

She could no longer concentrate at school due to the extreme headaches and body aches, feeling sick, or focus on school work. When she had a severe seizure she couldn’t remember what she had learned the week before, sometimes even the day before. Breanna would get exhausted very easily, be confused, and have involuntary tremors, muscles spasms and so much more. The list of symptoms goes on and on.

In early October 2012, she had over 15 seizures in one day so I was called home from work. I decided I was fed up with taking her to our local hospitals and getting nowhere. I took her to the Children’s Hospital in Tulsa.

She was admitted and put on an EEG monitor for several days. As they were doing the intake paperwork for her to be admitted they had asked all the common questions, for example: ‘Had there been any changes in her routine? Had we had an accident of any kind? Had I recently changed anything at home? Did I think that she was doing too much activity wise?’

The answers to all of the questions was of course ‘no’. Nothing had changed EXCEPT for the fact she had been given the first and second doses of the HPV vaccine, Gardasil.

After the doctor left the room, a nurse asked if I had researched information about Gardasil and I told her no, I had not because I was told that it was “perfectly safe.”

With the high risk of cancer in our family I thought “Why wouldn’t I want to try and prevent her from getting cancer in the future if that was something that I could do? It could possibly save her life,” or so I thought!

The nurse continued to talk to me about the vaccine and told me to go home and do some research on the Gardasil vaccine.

As Breanna sat in the hospital for the next several days, she only had one seizure. It happened before they got her hooked up to all the monitors because of course it took them forever to get us up to a room and get things going for the monitor. But after she had the one on the hospital floor she was assigned to, every nurse and doctor on duty on that floor was there in a heartbeat. And THEN they put in a rush order to get her hooked up to the monitors as soon as possible.

One morning the doctor asked if it was ok to speak to Breanna alone. I said yes. I was sure that it would be fine. I had no idea what was going to take place.

As he talked with her, he started accusing her of making all this up, that it was all to get attention, it was all in her head and she needed to grow up and stop playing games.

After he finished talking to her I went back into the room. I found her in tears, shaking and trying to pull all the wires off. She cried, “Please take me home – I don’t want to be here anymore.”

It took me a while to calm her down, but I finally got her to tell me what the doctor had said to her.

At this point I was ready to have him called back into the room so that I could give him a piece of my mind AND my fist. My blood was boiling by this point. How dare they treat my daughter this way!

I called the nurse in and asked to speak with a supervisor. They came in a short time later and were extremely apologetic.

I told them I did NOT want that physician to come back into her room under any circumstances or there was going to be a serious problem. I also demanded a different physician for her.

A new doctor came and said there was no activity that had showed up on the EEG testing while she was hooked up to the monitors and sent us home.

We were referred to a neurologist and many other kinds of specialist during this time. After being released from the hospital her symptoms continued to get worse. She was prescribed one seizure medication after another with no relief for over a year and a half. At that time the neurology visits literally consisted of us just walking into the room, her asking how my daughter had been and saying there would be a different medication waiting for her at our pharmacy. It literally took us longer to find a parking place than the time we were in the room with the doctor.

I finally got to the point where I understood we were getting no help. I took Breanna back to her pediatrician and demanded that he send her to another neurologist. I began to ask questions about whether her new symptoms could possibly be related to the HPV vaccine injections she had.

I was always reassured there was no way her current condition was associated with the HPV vaccine no matter what I told them. It did not seem to matter that she had none of these symptoms before she received Gardasil. It did not seem to matter that Gardasil had been the only new thing in her life when this nightmare began.

We started to see the new doctor and of course he ordered all the same tests which had already been done, office and in-home EEG’s, EKG’s, blood work, urine tests etc. He got the same results – everything was negative.

Breanna started to suffer in school due to the memory loss with the seizures, cramping tremors, extreme headaches etc. to the extent that it was causing her grades to go down. She couldn’t remember her school assignments. She had to quit all sports because she was just too weak to do any of that anymore.

Not understanding what was going on with her, most of her friends started to abandon her and not have anything to do with her any more. This caused her to go into a deep depressive state where she wouldn’t leave the house for months. She was too embarrassed about what people would say and worried that she was getting made fun of. That was very hard for her to deal with.

She has continued to miss school and not be able to complete a lot of her work due to her seizures and memory problems. We are now in the process of trying to get her in an online school so she can work at her own pace when she feels well enough to be able to do it. This way she can work at any time of the day so hopefully she will be able to graduate on time. One thing we are thankful for is that we have a good school. They have been very supportive of what is going on with her because they realize it is a medical issue. But when she has any kind of episodes at school I have to go and pick her up right away because of the potential liability for the school if she were to get injured at school.

The doctors have recently taken her off seizure meds but that simply made her seizures worse.

I lost my job of over 7 years because I have to be available to get her from school at a moment’s notice, be here to care for her and watch over her 24 hours a day. Right now, she has seizures 4 or more times a week, sometimes having more than one a day. She isn’t allowed to take a shower or bath without someone there with her. As a 16 year old teenager that is particularly difficult because she can’t have her privacy. As a mother I need and want to be there especially when she has a seizure and is in a state of confusion, when she has them so bad that she loses her ability to remember anyone or anything. We never know when the seizures will come or how long her memory loss will last so I have to be here at all times. Until this nightmare is over, it is impossible for me to hold down a job.

We continue to struggle with her every day to deal with whatever her issues may be that particular day. Breanna has accepted the fact that this is something she has to learn to cope with until we find someone who can help her. We struggle to help her make it through every single day. It is not easy, but we get through it as a family.

It breaks my heart to know my daughter had none of these medical issues until after she received those two shots of Gardasil. As a mother, I struggle daily with regret. I allowed my daughter to get this vaccine thinking I was doing the right thing. As it turned out, nothing was further from the truth.

Seeing your child suffer on a daily basis without the ability to do anything to help them is something no parent should ever have to deal with after a routine vaccine. I only wish I could turn back time so she could have the life she had before being injected with Gardasil.

Now that I have been able to share Breanna’s story I have discovered she isn’t the only young lady, or young boy, that has suffered with issues from this vaccine. It just breaks my heart to know there are so many girls who have very similar or even worse symptoms than those Breanna struggles with.

I am just thankful I did some research before I took her to get the last shot of Gardasil.

Thank you SaneVax for letting me share Breanna’s story. It has been a long road and will continue to be until she gets proper care and this poison out of her body.

Since first coming out with Breanna’s story I have been in contact with many other families who are going through the same kinds of issues or worse. It’s overwhelming, but comforting at the same time. We know we are not alone. Getting to speak with other moms who have been where we are is nice.

There are people that just don’t understand what Breanna’s issues are. I just pray for those people and hope that they never have to deal with what we deal with every day of our lives. I pray parents research all aspects of HPV vaccines before exercising their right to informed consent.

I pray no other parent makes the same mistake I did – allowing my daughter get the HPV vaccine before doing MY homework!

This article in it’s entirety is compliments of www.SaneVax.org

Shanna, my heart just aches as I read what Breanna and your family has suffered through these past few years.  I am so sorry that you had a physician demean and verbally attack your daughter.  It is hard to believe that there are some who choose an industry that is based on caring for others that lash out to the most vulnerable.  Just unthinkable, though it goes on all too frequently.

I am so glad that Breanna has a mother like you.  I think this is one of the most difficult trials,  for teens and their families right now, worldwide.  Thanks to people like you, the word is getting out and many will avoid this trial or stop and limit the number of shots and negative outcomes.

Breanna you are such a bright light and I hope you hang onto the hope of something better.  Keep the Lord by your side and the best possible outcomes will show forth.

As you know, many in the healthcare industry are unaware of the symptoms and care following a Gardasil shot.  I have a menu option on my blog with Featured Doctors that have experience with treating vaccine injuries and overall strengthening of the immune system.  SaneVax.org also has wonderful connections with doctors that have proven records of treating vaccine injuries with success.  The team at SaneVax is great to work with and you are in good hands with them.

I would like to share an artistic gift with you.  I hope this takes your mind away from your cares and brings you some light and joy into your life right now, and Breanna I hope you just let any hurtful words just wash away.  Always remember the bright, beautiful and strong girl you are.  You are amazing!!  You will be able to rise above this time in your life.  Just Believe. Your friend, jen.

 

 

 

 

FDA approved Gardasil 9: Malfeasance or Stupidity?#HPV#Family#iBelieve

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By Norma Erickson

SaneVax-FeaturedMalfeasance 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”?

FDAAccording 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.

Gardasil Ingredient Gardasil 9
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.

According to the Gardasil 9 package insert, the following percentage of serious adverse events were collected during follow-up (up to 48 months):

SERIOUS ADVERSE EVENTS

Number receiving shot Type of vaccine Percentage Serious AE’s Number of Serious AE’s
13,236 Gardasil 9 2.3% 305
7,378 Gardasil 2.5% 185

For the first time, Merck has disclosed what may indeed be close to the true rate of serious adverse events people are suffering after the use of Gardasil and will probably continue to suffer if they consent to using Gardasil 9. The only difference would be that the rates may be higher when used in the general population because certain at-risk groups are excluded from clinical trial participation but not from vaccination programs.

2.3-2.5% doesn’t sound that bad until you compare apples to apples. Cervical cancer rates are always quoted as # per 100,000. Given the above information, for every 100,000 people using Gardasil 9 there would be 2,300 serious adverse events. The cervical cancer diagnosis rate in the United States is 7.9/100,000.

What health official in their right mind is willing to anticipate 2,300 serious adverse events to try and prevent 7.9 cases of cervical cancer?

Keep in mind that the cost of vaccinating 100,000 people is around $30 million ($100 per injection, 3 injections). This doesn’t even begin to address the cost of treating 2,300 serious adverse events, the emotional, physical and financial expense to families and the cost to society via the lost productivity of the injured.

Bombshell #2 Systemic Autoimmune Disorders

An autoimmune disorder occurs when the body’s immune system attacks and destroys healthy body tissue by mistake. There are more than 80 types of autoimmune disorders. Many of the people diagnosed as suffering systemic autoimmune disorders after HPV vaccines were first mis-diagnosed with conversion disorder or psychosomatic illnesses. Below are the rates of “new medical conditions potentially indicative of autoimmune disorders” experienced during Merck’s Gardasil 9 clinical trials.

SYSTEMIC AUTOIMMUNE DISORDERS

Number receiving shot Type of vaccine Autoimmune Disorders Number
13,234 Gardasil 9 2.4% 321
7,378 Gardasil 3.3% 240

So, in addition to the serious adverse events, you now have an additional 2,400 people who may be left with systemic autoimmune disorders. How can any health official possibly think Gardasil 9 is worth this kind of risk?

Bombshell #3 Pregnancy Outcomes

According to the Gardasil 9 package insert, 1,028 women who were injected with Gardasil 9 became pregnant during the course of the clinical trials along with 991 women who had been injected with Gardasil. Overall, 14.1% of the Gardasil 9 women suffered adverse outcomes while 17.0% of the Gardasil women suffered the same fate. A total of 313 women either lost their babies to spontaneous abortion or late fetal death or gave birth to children with congenital anomalies.

This population was further broken down into those who became pregnant within 30 days of an injection and those who became pregnant more than 30 days post-injection. The charts are below.

OUTCOME WHEN INJECTED WITHIN 30 DAYS OF PREGNANCY ONSET

Number of pregnancies Type of vaccine % abortion/stillborn Lost Babies
62 Gardasil 9 27.4% 17
55 Gardasil 12.7% 7

OUTCOME WHEN INJECTED MORE THAN 30 DAYS BEFORE PREGNANCY ONSET

Number of pregnancies Type of vaccine % abortion/stillborn Lost Babies
960 Gardasil 9 10.9% 105
933 Gardasil 14.6% 136

Note: The numbers from these two charts do not add up to the total number Merck stated in the first paragraph. That is because in the ’more than 30 days’ group there were also 20 cases of congenital anomalies after Gardasil 9 and 21 cases after Gardasil.

Merck stated in the package insert, ”The proportions of adverse outcomes observed were consistent with pregnancy outcomes observed in the general population.”

Unless they are talking about some country other than the United States, THIS IS NOT TRUE.

According to the CDC’s latest publication on fetal mortality, the rate of spontaneous abortions and fetal deaths in the United States is 6.05/1,000 pregnancies or 0.605% – hardly 10.9%, much less 27.4%, and certainly not ’consistent with outcomes observed in the general population’ of the United States.

Do CBER officials not even go to the trouble of verifying the ’facts’ presented by vaccine manufacturers when they are ’evaluating data concerning the safety, effectiveness, and appropriate use’ of vaccines?

Whether these actions, or lack of proper actions are a result of malfeasance, laziness, or just plain stupidity does not matter at this point. It is obvious to the most casual observer the FDA either cannot or will not properly handle their responsibility to protect and preserve the public’s health and safety. They have violated the public trust.

There is absolutely no excuse for exposing young women and men to this level of risk for a vaccine that provides nothing other than promises of results far down the road.

The FDA needs to be removed from the responsibility of ’assuring the safety, efficacy and security’ of vaccines. It is quite obvious they are not up to the task. They are most certainly not acting in the best interests of the public.

Medical consumers – do not consent to the administration of Gardasil 9 unless you and your medical provider have read and discussed the entire package insert together. The choice is yours, make it an informed one.

This article in it’s entirety, is compliments of www.SaneVax.org

How This Journalist Was Censored For Writing Reasonably About Vaccines#Android#Family#Vaccines

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Written By: Jennifer Marguilis, Ph.D

When the editor of the Washington Independent Review of Books invited me to review a recent narrative book about vaccines, I said yes. It was a natural fit, since I’ve been researching vaccines for the past fifteen years, participating publicly in vaccine debates, and writing about the vexing issue of childhood vaccination for nearly as long.

But when an advanced reading copy came in the mail, I recognized the author’s name as someone who had mentioned me in a January 2013 article in Harper’s Magazine. I flipped through the book, and since her essay from Harper’s was printed there nearly verbatim, my name was also in the book.

I called the editor to ask if that might create the perception of a conflict of interest.

“Do you think you can write a fair and balanced review,” the editor asked me on the phone.

I do not know this writer personally. We’ve never spoken or met. We aren’t connected on social media. We did have a very brief email exchange after her Harper’s article came out — I wrote to thank her for mentioning me. I have never taken money from her, as many scientists who are asked to review industry products routinely do…

Read the Full Article Here

www.greenmedinfo.com

Making Vaccines with cancer cells: How safe is it?#Vaccines#Android#Family

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By Sandy Lunoe, Guest Author

Will vaccines produced using human cancer cells make vaccines more likely to cause cancer?

Do the amounts of residual cancer DNA present in the vaccines vary between batches?

What genetic mutations could occur should the residual cancer DNA enter a human cell and begin reproducing?

Will manufacturers be obliged to conduct adequate safety studies before these vaccines are licensed?

The truth is no one knows.

Never before have cells that are derived directly from human cancer tumors been considered for use in vaccine production. Incredibly, this method has been approved despite the fact that it cannot be guaranteed that the vaccines will not induce cancer tumors in recipients.

Based on the approval by FDA (Food and Drug Administration) millions of vaccines which may induce cancer tumors will be produced. Where are the protests?

From a salvaged transcript (1) of the several hour long meeting in September 2012 between FDA and vaccine manufacturers some of the statements which jumped out of the page are quoted in this article…

Read the entire article here

www.sanevax.org

This is How Doctors are Puppets for Vaccine Manufacturers#Vaccines#Medical#Android

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By Sandy Lunoe

Manufacturers hide information from doctors about ingredients and conceal their sinister plans for vaccine production so that doctors will continue to feel comfortable recommending vaccines.

Doctors have no possibility whatsoever of knowing the complete composition of vaccines, nor do health authorities – or, in fact, anyone else.

Here are some of the methods manufacturers use to conceal the presence of ingredients in vaccines:

Trade Secrets

Some “GRAS” (acronym for Generally Recognized as Safe) substances are not revealed due to trade secrets. This includes many oils, including peanut oil.

This is one reason why there are millions of people in the world who are allergic to peanuts and other vaccine ingredients. [1]

Dispensation from Labeling Requirements

Incredibly, the presence of almost any substance may be concealed on the condition that manufacturers apply for dispensation to official labeling requirements.

This exemption applies even to the presence of neurotoxic substances such as aluminium…

Read the Entire Article Here

http://vactruth.com