FDA Information on Gardasil – Betrayal of the Public Trust?
October 28, 2011
By Norma Erickson, President
In response to the recent announcement by SANE Vax Inc. of the discovery of genetically modified HPV DNA residue in multiple vials of Gardasil, the FDA posted the following page on their site, FDA Information on Gardasil – Presence of DNA Fragments Expected, No Safety Risk. The FDA lists several ‘key facts’ in an obvious attempt to allay any fears which may have arisen over the discovery of foreign DNA in yet another ‘safe and effective’ vaccine. Unfortunately, these ‘key facts’ raise more questions than answers.
In spite of the fact the FDA claims their mission is, helping the public get the accurate, science-based information they need to use medicines, there are no scientific references and no indication that these ‘key facts’ are anything more than damage control statements. American medical consumers deserve better from an agency funded by taxpayers and entrusted with the mission of being responsible for protecting the public health by assuring the safety, efficacy and security of human and veterinary drugs, biological products, medical devices…… (FDA mission statement)
According to the Consumer Justice Group, in the last 27 years, there have been 31 drugs approved ‘safe and effective’ by the FDA which were subsequently withdrawn from the market due to safety concerns not uncovered during clinical trials. No one will ever know the true cost in human suffering resulting from adverse reactions to these 31 FDA approved ‘safe and effective’ medications.
Medical consumers worldwide are not willing to risk their children’s health and perhaps their very lives on a vaccine that ‘might’ prevent cancer 20 to 30 years down the road. Parents are not willing to wait until the adverse events post Gardasil vaccination reaches the same numbers as Vioxx did before the vaccine is withdrawn from the market.
Medical consumers around the world are no longer willing to accept the FDA’s ‘word’ when it comes to HPV vaccines and their children’s health and safety. They are demanding scientific proof of the claims made by the FDA and vaccine manufacturers.
FDA ‘Key Facts,’ and questions raised by SANE Vax Inc. on behalf of medical consumers:
Gardasil does contain recombinant HPV L1-specific DNA fragments, but these are not contaminants. DNA encoding the HPV L1 gene is used in the vaccine manufacturing process to produce the virus-like particles that make up the vaccine. The presence of these DNA fragments is expected, is not a risk to vaccine recipients, and is not a safety factor. DNA is the “blueprint” for the majority of living organisms and carries the genetic instructions for how cells function and grow.
Do these ‘expected’ DNA fragments contain plasmid?
Please explain why, if these HPV rDNA fragments are ‘expected,’ why did the manufacturer have to invent a patented process to remove them?
Please provide the DNA sequences of all ‘expected’ HPV DNA fragments in the vaccine.
Provide copies of all scientific studies that prove these DNA fragments are ‘not a risk to vaccine recipients.’
Do the above referenced studies include studies regarding the potential safety concerns of these ‘expected’ DNA fragments being tightly bound to aluminum hydroxyphosphate micro-particles?
The vaccine manufacturing process is highly regulated under FDA’s current good manufacturing practice requirements, including inspections conducted by FDA of the manufacturing processes and facilities.
Please publish all reports of FDA inspections of the four manufacturing facilities from which the Gardasil samples tested at Milford Medical Laboratory originated since Gardasil’s FDA approval, including the DNA sequences of the detectable residual HPV DNA molecules and the quantity of total HPV DNA per Gardasil dose.
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. Gardasil does not contain DNA from other HPV genes or any full-length infectious HPV genomes.
If Merck and Co., Inc. and the FDA knew small quantities of residual recombinant HPV L1-specific DNA fragments remain in Gardasil, why do marketing and information packets from around the world specifically state the vaccine contains ‘no viral DNA’?
Please publish the manufacturer’s dated report, stating the acceptable quantities and the sequences of the residual recombinant HPV L1-specific DNA fragments that remain in the vaccine.
Is the FDA aware that injected naked microbial or viral DNA need not be either full-length or ‘infectious’ to potentially cause a health problem?
As it does with all vaccines, FDA continues to monitor the safety of Gardasil. For example, FDA recently evaluated the results of a postmarketing study, which included 189,629 females ages 9 to 26 years, 51% of whom were 9 to 15 years of age to assess the risk for onset of new autoimmune diseases after vaccination with Gardasil. Examples of these types of diseases include juvenile rheumatoid arthritis, lupus, multiple sclerosis, etc. The results of this study showed that there is no elevated risk for onset of new autoimmune disease associated with the use of Gardasil.
Did the 189,629 females selected for postmarketing study include cases reported to VAERS?
Is the FDA aware there are 75 vaccines approved for use in the United States and for the first five years after the approval of HPV vaccines, adverse events reported after HPV vaccinations account for a full 16% of the entire VAERS database? See the analysis here.
Why does this fact not raise a red flag prompting an investigation?
FDA also continually reviews all reports of the Vaccine Adverse Event Reporting System after vaccination with Gardasil, and there is no evidence of unusual clinical patterns or high reporting rates of adverse events, including autoimmune diseases.
Is the FDA aware of the fact that out of 75 FDA approved vaccines, adverse injury reports post-HPV vaccination account for the following percentages of VAERS reports for all vaccines?
24% of all life-threatening events
26% of all emergency room visits
25% of all hospitalizations
33% of all extended hospital stays
36% of all disabling events
Why do the above statistics, verifiable here, not raise a red flag requiring investigation?
Did the FDA consider cases of immune-based acute disseminated encephalomyelitis after Gardasil injections (1-7) evidence of unusual clinical patterns? If not, why not?
Medical consumers around the globe are asking the same questions. They will no longer accept semantics games, changing definitions, or public relations statements. Medical consumers demand scientific evidence.
If the FDA is actually protecting the public health, there should be no problem providing scientific documentation answering the questions above. Anything less than full compliance is a betrayal of the public trust, not to mention a violation of the public’s right to informed consent. Notions of equal treatment should be cast aside under the circumstances–can the FDA really support exposing our boys to these significant health risks?
References:
Sutton I, Lahoria R, Tan I, Clouston P, Barnett M. CNS demyelination and quadrivalent HPV vaccination. Mult Scler. 2009; 15:116-9.
Wildemann B, Jarius S, Hartmann M, Regula JU, Hametner C. Acute disseminated encephalomyelitis following vaccination against human papilloma virus. Neurology. 2009;72:2132-3.
Mendoza Plasencia Z, González López M, Fernández Sanfiel ML, Muñiz Montes JR. Acute disseminated encephalomyelitis with tumefactive lesions after vaccination against human papillomavirus. Neurologia. 2010; 25:58-9.
Chang J, Campagnolo D, Vollmer TL, Bomprezzi R. Demyelinating disease and polyvalent human papilloma virus vaccination. J Neurol Neurosurg Psychiatry. 2010 Oct 9. doi:10.1136/jnnp.2010.214924
DiMario FJ Jr, Hajjar M, Ciesielski T. A 16-year-old girl with bilateral visual loss and left hemiparesis following an immunization against human papilloma virus. J Child Neurol. 2010; 25:321-7.
Balamoutsos G, Bouktsi M, Paschalidou M, Tascos N, Milonas I. A report of five cases of CNS demyelination after quadrivalent human papilloma virus vaccination: could there be any relationship? (Abstract No. P297)- Poster Access : www.guthyjacksonfoundation.org/services/download.php?2297.pdf+374
Rossi M, Bettini C, Pagano C. Bilateral papilledema following human papillomavirus vaccination. J Med Cases. 2011; 2:222-4.
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Saturday, October 29, 2011
Monday, October 17, 2011
How Far Will Taxpayer-Sponsored Health Agencies Go To Protect HPV Vaccines?
How Far Will Taxpayer-Sponsored Health Agencies Go To Protect HPV Vaccines?
October 17, 2011 By Norma Leave a Comment
By Norma Erickson, President
Rather than address legitimate medical consumers’ concerns about HPV vaccines, government health agencies decide to change the definitions and hope the problems will go away.
28 Feb 2011, SaneVax Inc. published an article titled, Health Care Fraud: HPV ‘vaccines’ are not vaccines at all. This article quoted the definition of ‘vaccine’ from a website sponsored by the Department of Health and Human Services (HHS). On that date, the definition of ‘vaccine’ was, “a product of a weakened or killed microorganism (bacteria or virus) given for the prevention or treatment of an infectious disease.”
Everyone knows infection is not synonymous with an infectious disease. You cannot ‘catch’ cancer from someone else. Therefore, it is not an infectious disease. By the HHS definition, any injection administered to protect against cancer of any type is not a vaccine.
The SaneVax article went on to quote from a publication entitled, FDA 101: Health Fraud Awareness. This document clearly states, “Health fraud is the deceptive sale or advertising of products that claim to be effective against medical conditions or otherwise beneficial to health, but which have not been proven safe and effective for those purposes.”
It appears the United States Department of Health and Human Services, the agency responsible for oversight of the FDA, agreed with the SANE Vax assessment of HPV ‘vaccines.’ However, instead of addressing the problem of potential fraud the DHHS decided to re-route the original page and alter the definition of vaccine. The DHHS definition of vaccine now reads, “A product that produces immunity therefore protecting the body from the disease. Vaccines are administered through needle injections, by mouth and by aerosol.”
You can verify the change by watching closely after clicking on the following link:
http://www.hhs.gov/nvpo/glossary1.htm (For a brief moment, you will see the original page, before it is re-routed to the new page with the altered definition.)
Much the same thing happened when SANE Vax Inc. reported the discovery of recombinant HPV DNA firmly attached to the aluminum adjuvant in 13 lots of Gardasil from multiple countries around the world.
According to government ‘health’ agencies representing at least thirty countries from around the world, the words “no viral DNA” do not mean what any medical consumer would assume they mean. In spite of the fact ‘no viral DNA’ appears on multiple government ‘health’ agency documents; now, medical consumers are told, “All medicinal products manufactured using recombinant technology may contain small fragments of residual DNA.”
Consider the following excerpts from an FDA document stressing the importance of medical consumers reporting problems with various products regulated by the FDA:
Consumers can play an important public health role by reporting to FDA any adverse reactions or other problems with products the agency regulates.
The testing that helps to establish the safety of products, such as drugs and medical devices, is typically conducted on small groups before FDA approves the products for sale.
Some problems can remain unknown, only to be discovered when a product is used by a large number of people.
When problems with FDA-regulated products occur, the agency wants to know about them ……
It appears that ‘knowing’ about a problem and doing something about it are two different things. SaneVax Inc. has reported problems with HPV vaccines to the FDA on multiple occasions. (All correspondence can be viewed here.) Regarding the most recent concern about recombinant (genetically modified) HPV DNA found in Gardasil™ from multiple manufacturing facilities, the FDA completely ignored the fact that the residual HPV DNA is firmly attached to the aluminum adjuvant. Furthermore, FDA officials appeared more concerned with semantics games than asking to examine the detailed genetic sequences contained in the laboratory results. Perhaps if they did, their own laboratories could confirm the Genbank DNA sequences found.
The FDA, CDC, and DHHS all have their salaries paid by American taxpayers. They are charged with the mission of protecting the public’s health and safety. Do these agencies truly believe American medical consumers are so gullible that they will dismiss such an obvious case of misleading and possibly fraudulent marketing of not only one, but two medical interventions that do not meet the definition of ‘vaccine’ being marketed and sold to the world as cancer vaccines?
Do FDA officials really believe medical consumers are naïve enough to accept a proverbial pat on the head from the people they pay to protect their health and safety? The SANE Vax team does not think so. Now that the FDA ‘knows’ about the problem, it is time for them to perform the job they are paid to do.
Give medical consumers scientific documentation proving HPV ‘vaccines’ actually live up to the marketing claims made by the manufacturers. Provide scientific evidence proving residual HPV rDNA firmly attached to an aluminum adjuvant poses no health risk when injected into their children.
Medical consumers world-wide deserve more than altered definitions and semantics games, particularly when their children’s health is at stake. Medical consumers deserve scientific facts. Medical consumers deserve the truth. Anything less deprives them of their right to informed consent.
October 17, 2011 By Norma Leave a Comment
By Norma Erickson, President
Rather than address legitimate medical consumers’ concerns about HPV vaccines, government health agencies decide to change the definitions and hope the problems will go away.
28 Feb 2011, SaneVax Inc. published an article titled, Health Care Fraud: HPV ‘vaccines’ are not vaccines at all. This article quoted the definition of ‘vaccine’ from a website sponsored by the Department of Health and Human Services (HHS). On that date, the definition of ‘vaccine’ was, “a product of a weakened or killed microorganism (bacteria or virus) given for the prevention or treatment of an infectious disease.”
Everyone knows infection is not synonymous with an infectious disease. You cannot ‘catch’ cancer from someone else. Therefore, it is not an infectious disease. By the HHS definition, any injection administered to protect against cancer of any type is not a vaccine.
The SaneVax article went on to quote from a publication entitled, FDA 101: Health Fraud Awareness. This document clearly states, “Health fraud is the deceptive sale or advertising of products that claim to be effective against medical conditions or otherwise beneficial to health, but which have not been proven safe and effective for those purposes.”
It appears the United States Department of Health and Human Services, the agency responsible for oversight of the FDA, agreed with the SANE Vax assessment of HPV ‘vaccines.’ However, instead of addressing the problem of potential fraud the DHHS decided to re-route the original page and alter the definition of vaccine. The DHHS definition of vaccine now reads, “A product that produces immunity therefore protecting the body from the disease. Vaccines are administered through needle injections, by mouth and by aerosol.”
You can verify the change by watching closely after clicking on the following link:
http://www.hhs.gov/nvpo/glossary1.htm (For a brief moment, you will see the original page, before it is re-routed to the new page with the altered definition.)
Much the same thing happened when SANE Vax Inc. reported the discovery of recombinant HPV DNA firmly attached to the aluminum adjuvant in 13 lots of Gardasil from multiple countries around the world.
According to government ‘health’ agencies representing at least thirty countries from around the world, the words “no viral DNA” do not mean what any medical consumer would assume they mean. In spite of the fact ‘no viral DNA’ appears on multiple government ‘health’ agency documents; now, medical consumers are told, “All medicinal products manufactured using recombinant technology may contain small fragments of residual DNA.”
Consider the following excerpts from an FDA document stressing the importance of medical consumers reporting problems with various products regulated by the FDA:
Consumers can play an important public health role by reporting to FDA any adverse reactions or other problems with products the agency regulates.
The testing that helps to establish the safety of products, such as drugs and medical devices, is typically conducted on small groups before FDA approves the products for sale.
Some problems can remain unknown, only to be discovered when a product is used by a large number of people.
When problems with FDA-regulated products occur, the agency wants to know about them ……
It appears that ‘knowing’ about a problem and doing something about it are two different things. SaneVax Inc. has reported problems with HPV vaccines to the FDA on multiple occasions. (All correspondence can be viewed here.) Regarding the most recent concern about recombinant (genetically modified) HPV DNA found in Gardasil™ from multiple manufacturing facilities, the FDA completely ignored the fact that the residual HPV DNA is firmly attached to the aluminum adjuvant. Furthermore, FDA officials appeared more concerned with semantics games than asking to examine the detailed genetic sequences contained in the laboratory results. Perhaps if they did, their own laboratories could confirm the Genbank DNA sequences found.
The FDA, CDC, and DHHS all have their salaries paid by American taxpayers. They are charged with the mission of protecting the public’s health and safety. Do these agencies truly believe American medical consumers are so gullible that they will dismiss such an obvious case of misleading and possibly fraudulent marketing of not only one, but two medical interventions that do not meet the definition of ‘vaccine’ being marketed and sold to the world as cancer vaccines?
Do FDA officials really believe medical consumers are naïve enough to accept a proverbial pat on the head from the people they pay to protect their health and safety? The SANE Vax team does not think so. Now that the FDA ‘knows’ about the problem, it is time for them to perform the job they are paid to do.
Give medical consumers scientific documentation proving HPV ‘vaccines’ actually live up to the marketing claims made by the manufacturers. Provide scientific evidence proving residual HPV rDNA firmly attached to an aluminum adjuvant poses no health risk when injected into their children.
Medical consumers world-wide deserve more than altered definitions and semantics games, particularly when their children’s health is at stake. Medical consumers deserve scientific facts. Medical consumers deserve the truth. Anything less deprives them of their right to informed consent.
GARDASIL INJURY VICTIMS HOLD PRESS CONFERENCE
LAS VEGAS, NV, OCTOBER 17TH, 2011: In response to the discussions surrounding the aggressive mandating of the Gardasil vaccine that have taken place during the Republican debates, the Canary Party will be holding a press conference on the damaging outcomes of this vaccine push featuring families of young women injured by and lost to the Gardasil vaccine, Tuesday, October 18th at 3pm outside the East entrance to The Venetian's Sands Expo and Convention Center at 3355 Las Vegas Boulevard South
Las Vegas 89109, prior to the GOP debate. All of the Republican candidates have been invited to attend.
Hearing directly from these families is crucial:
“Alexis spent six months at the University of New Mexico Hospital enduring plasmapheresis, two spinal taps and ultimately a diagnosis of encephalitis from viral infection, traumatic brain injury and a seizure disorder.”
“She was and honor roll student in the seventh grade, failing in the eighth grade and starting high school in a special education class in diapers. She’s reading at a fifth grade level with maybe the comprehension of fourth grader. She was kicked out of school this year in just the third week.”
“After that day, she never returned to school. She couldn’t focus on homework — BaLeigh used to be very articulate, she had a lot of wisdom for her age, very observant about life. Afterward she was ill, she had a hard time following or carrying on a conversation.”
“We eventually saw a neurologist at Johns Hopkins and we felt like were practically kicked out of the hospital. Turned out his research partner was sponsored by Merck.”
“Chris died 18 days after her third dose of Gardasil.”
“Brittney didn’t want this vaccine in the first place.”
When Governor Rick Perry mandated the HPV vaccine in Texas, the response from the public and the legislature was a clear one, that families are the ones that should be making the decisions what pharmaceuticals to give their children, not government officials, and his mandate was quickly struck down. Last week Californians began learning that Governor Jerry Brown had quietly signed into law AB499 that gave children as young as 12 the decision making responsibility of whether or not to receive the HPV vaccine, removing the right of parents to even know the vaccine was given. This statute violates federal vaccine safety law requiring fully informed consent by a parent for any vaccine delivered to a child and is completely inappropriate given that the vaccine that has a 30 page package insert that no 12 year old could comprehend and is undergoing a new round of scrutiny as to its safety and effectiveness.
Las Vegas 89109, prior to the GOP debate. All of the Republican candidates have been invited to attend.
Hearing directly from these families is crucial:
“Alexis spent six months at the University of New Mexico Hospital enduring plasmapheresis, two spinal taps and ultimately a diagnosis of encephalitis from viral infection, traumatic brain injury and a seizure disorder.”
“She was and honor roll student in the seventh grade, failing in the eighth grade and starting high school in a special education class in diapers. She’s reading at a fifth grade level with maybe the comprehension of fourth grader. She was kicked out of school this year in just the third week.”
“After that day, she never returned to school. She couldn’t focus on homework — BaLeigh used to be very articulate, she had a lot of wisdom for her age, very observant about life. Afterward she was ill, she had a hard time following or carrying on a conversation.”
“We eventually saw a neurologist at Johns Hopkins and we felt like were practically kicked out of the hospital. Turned out his research partner was sponsored by Merck.”
“Chris died 18 days after her third dose of Gardasil.”
“Brittney didn’t want this vaccine in the first place.”
When Governor Rick Perry mandated the HPV vaccine in Texas, the response from the public and the legislature was a clear one, that families are the ones that should be making the decisions what pharmaceuticals to give their children, not government officials, and his mandate was quickly struck down. Last week Californians began learning that Governor Jerry Brown had quietly signed into law AB499 that gave children as young as 12 the decision making responsibility of whether or not to receive the HPV vaccine, removing the right of parents to even know the vaccine was given. This statute violates federal vaccine safety law requiring fully informed consent by a parent for any vaccine delivered to a child and is completely inappropriate given that the vaccine that has a 30 page package insert that no 12 year old could comprehend and is undergoing a new round of scrutiny as to its safety and effectiveness.
Saturday, October 15, 2011
The HPV vaccine - what do you really know about it?
Friday, October 14, 2011 by: Rosemary Mathis, Vice President of Victim Support, SANE VAX, INC
(NaturalNews) If you are considering vaccinating your child with an HPV vaccine, what information have you read, and what questions have you asked?What do you KNOW about the human papillomaviruses (HPV) which the medical profession says causes cervical cancer?
If you are going to vaccinate your child on the word of the medical profession, and don't want any further information, then stop right here. But be aware that ignorance is not bliss. And that the medical system has deliberately not told you everything you need to know about either the viruses, or the vaccine.
If you want to take responsibility for your own decisions, rather than hand over responsibility to the medical profession, then you might be interested in some of the following questions and answers, which deserve truthful answers that the vaccine industry doesn't want to give you:
Question: Publicity for Gardasil says that girls should have this HPV vaccine before sexual intercourse, because they don't catch this virus until they are sexually active. Is this correct?
No, this is not correct. Over the last 20 years, the medical profession has documented that human papillomaviruses can be transmitted during pregnancy, after pregnancy, from child to child, and adult to child.
Question: Why then are we told that these human papillomaviruses can only be contracted after sex?
Because adolescents are the market Merck was targeting, and to admit that the viruses can be acquired naturally before sex, doesn't suit Merck. The medical literature for the last 20 years has also stated that to ignore the fact that HPV viruses can cause silent infection at any age 'has implications for any vaccination programme,' though those 'implications' have never been spelled out. However, they expect parents to naively believe that intelligent human papillomaviruses know they aren't allowed to let themselves loose, until the first act of sexual intercourse. And for some reason, most parents believe this sort of nonsense statement.
Question: Are these viruses implicated in cervical cancers, and other cancers?
Yes they are - but primarily in people, whose innate immune system is struggling because they eat rubbish, drink alcohol, smoke cigarettes, don't get enough sleep, and burn the candle at 12 ends. Much more than a virus is required for a woman to get cervical cancer.
Question: Doesn't everyone get human papillomavirus infections?
Yes. Not only has 'everyone' but just about any species that breathes gets papillomavirus infections - even lizards. The medical literature shows that a good diet, correct mineral and vitamin intake, and living a healthy lifestyle, normally results in the recipient throwing off HP infections easier than a cold, and all they have to show for it, is lifelong natural immunity. Healthy lifestyles don't fill Big Pharma bank balances, so you won't be told about that.
Question: But I've been told this vaccine is so important! Is that wrong
This vaccine is very important for Merck's accountants - vitally important. It's 'the' product that is supposed to dig Merck out of its current financial woes.
But is it important for your child? No. The cervical smear programme stopped people dying of cervical cancer long before 'fear-no-longer' Gardasil came along. And because the vaccine only covers two types out of at least 20 supposedly carcinogenic HP virus types (amongst at least 300 different strains), people who have cancer phobia will still want to have smears anyway. Today, 90% of all deaths from cervical cancer occur in the third world countries which don't have such a programme, or the ability to deal with abnormal smears even if they had a smear programme. The primary drivers of cervical cancer in third world countries are chronic malnutrition, and fundamentally atrocious living conditions, which happens to create the most susceptible population with the least resources.
Question: So why have I been recommended to inject my child with three Gardasil vaccines?
Because if a vaccine is available the medical system tries to scare everyone into using it. After all, it's much easier to 'believe' their assumption that antibodies from Gardasil will still be around 40 years from now. It's much easier not to have to pay attention to diet, and all the other things which would make sure most people never got cancer in the first place.
But the bottom line is that Merck developed Gardasil in the hope that it would be a 'block-buster' vaccine which would help pay for all the litigation Merck faces as the result of another Merck drug, called Vioxx, which maimed and killed lots of people, whose families then turned around and sued Merck for millions of dollars.
Obviously, Merck isn't going to make any money from the third world -the countries that really need it, according to Dr Frazer who co-patented the vaccine. So Merck decided to target all the rich countries that do not need Gardasil. By charging wealthy countries lots of money, then maybe someday about forty years from now..., they might get around to providing it to people in the third world, if they are still around. Which is a bit farcical, when in those countries, what the people could really do with, is decent food, clean water, getting rid of nepotistic dictators and warring tribes, being provided with basic healthcare, and the means of growing their own food... but all that's much too hard. Particularly when Merck's main aim is making money and staying in business.
Question: What is in Gardasil?
According to the data sheet, the vaccine supposedly contains 'no viral DNA1' and each 0.5 mL dose of the vaccine contains:
20 mcg of HPV 6 L1 protein
40 mcg of HPV 11 L1 protein
40 mcg of HPV 16 L1 protein
20 mcg of HPV 18 L1 protein
225 mcg aluminum (as amorphous aluminum hydroxyphosphate sulfate adjuvant2)
9.56 mg of sodium chloride
0.78 mg of L-histidine
50 mcg of polysorbate 80 (shown to induce infertility in mice, which is why it's the main ingredient in depo-provera, and which also makes the brain blood barrier easier to penetrate)
35 mcg of sodium borate
water for injection
Question: What do you mean,'Supposedly'?
Contrary to the manufacturers' documents, the vaccine does actually contain Viral DNA. According to documents filed with Medsafe New Zealand, each vaccine also has a much higher amount of HPV protein than stated on the product insert, in order to ensure that as the vaccine degrades over time, at the END of the shelf life, the vaccine will actually contain the stated dose on the vial.
Question: What do you mean, this vaccine has recombinant HPV viral DNA! What is recombinant HPV viral DNA?
This is where small lengths of genes from two different sources, are combined to make a single recombined length of genes which will perform a specific function.
Question: The New Zealand Government, the manufacturers and all the health authorities not only assured us that there is no DNA, but they say SANE Vax Inc.'s allegations of contamination with DNA are a load of smelly porkies! Explain yourself please?
No-one from the Government, FDA, EMA, or Health Departments have at any time, asked to see the test results of the vaccine, which SANE Vax Inc. commissioned. So, on what basis do they think that the test results are incorrect?
Gardasil was made by taking a DNA sequence (which makes the virus "envelope") from different types of papillomaviruses found in cancerous cervical cells. This viral genetic sequence was then spliced into a plasmid 3 - a circular piece of bacterial DNA (which helps divide the bacterial chromosomes) and allows the HPV DNA to be cloned into yeast. Plasmid DNA also encourages quick manufacture of the 'balls,' by the HPV genes. The genetically engineered mix then makes lots of little empty balls, or 'virus like particles' as seen in photo4 of the Gardasil vaccine.
Then according to Merck's patent5, they have a highly sophisticated process which is supposed to filter out and remove 'contaminating biomolecules, including DNA, lipids and proteins.'
What the test results found, was that some recombinant DNA sequences originating from different types of the virus DNA used to make the vaccine, are still in the vaccine.
Question: What are all those other bits in that photo?
Aluminium, and presumably more mashed up virus like particles. But according to the tests commissioned by SANE Vax Inc., viral DNA used to make those little balls and mashed up pieces, are not removed from Gardasil.
Question: But FDA says that these recombinant DNA are "expected" when using this process. Isn't that true?
No. If those DNA fragments were "expected" components of Gardasil, they would have been listed in the ingredients of the vaccine, and documentation should exist showing why they are a safe and 'essential' ingredient in the vaccine.
Question: How does this fancy patented purification process tell the difference between culture medium DNA, yeast DNA and HPV DNA?
You tell me and we'll both know.
Question: If SANE-vax's tests ARE actually correct, why did a purification process which is supposed to remove DNA lipids, proteins, and biomolecules not work?
I think Merck would like to know the answer to that as well. In the meantime, FDA are covering Merck's butt for them.
Question: But isn't there a final product purity test for Gardasil?
In New Zealand, according to paper work submitted to Medsafe, there are no final purity tests, because Merck believes their filtration process is good enough without them.
Question: But aren't there filtration tests designed to make sure the process is good enough?
According to paper work submitted to Medsafe, there are no filtration "adequacy" tests because Merck believes their process is good enough without them.
Question: Isn't Gardasil made the same way as the Hepatitis B vaccine?
Yes, and according to FDA6 documentation, "Assays for cesium, polysaccharides, DNA, pyrogens and sterility are performed" on the Hepatitis B bulk product. You'd think the same would be done for Gardasil, wouldn't you?
Question: Does the Hepatitis B vaccine also contain genetically engineered, recombinant DNA?
It would appear that the Hepatitis B vaccine could ALSO contain a similar kind of genetically manipulated DNA (in spite of tests to ensure DNA removal). Such recombinant DNA in the Hepatitis B vaccines is also not mentioned in its data sheet or constituent list.
FDA, in its reply to SANE Vax Inc., intimated that Hepatitis B vaccine also contains recombinant DNA, and that such unstated DNA was quite "acceptable". So they are covering Merck's butt for that as well.
Question: FDA says these particles are no big deal because they can't cause infection. Is that true?
No it's not. The point of a vaccine is to form antibodies to various substances called "antigens" in the vaccine. DNA doesn't have to cause infection to spell trouble. Because the recombinant DNA is tightly bound to the aluminium, the aluminium turns the DNA into an 'antigen,' something the immune system has to react to. But an abnormal immune response, especially to an aluminium-bound DNA, could result in antibodies which cross react and turn against healthy DNA. That could cause autoimmune disease, brain inflammation, joint inflammation, and major disruption to energy pathways, hormone functions and a vast array of other biological pathways, which normally keep an adolescent healthy, physically and mentally.
Question: But FDA says that Gardasil is very safe and doesn't cause anything more than a sore arm. Isn't that true?
No. America's FDA and all medical authorities say that all vaccines are safe apart from sore arms, and that everything else that happens after a vaccine is a coincidence..., and anyone who says otherwise, needs their head looked at.
FDA monitors all vaccines by using a system called VAERS, short for the Vaccine Adverse Event Reporting System, which is known to only collect 10% of reactions at most, and reporting is voluntary, not mandatory. On the one hand, they 'consult' this system, but on the other, they consider that all reactions sent to this system have nothing to do with the vaccine at all. So in terms of a monitoring system, they might as well not have one at all. In fact, they might as well do away with it altogether, since to them, the fact that Gardasil reports comprise 20% of all reported reactions appears to them to be some fabricated nuisance. It doesn't seem to occur to the FDA, that perhaps there is something badly wrong with this 'lovely safe' vaccine, which their crystal ball says will prevent your child from having cervical cancer, by the (average) age of 54.
Question: Are you telling me, I shouldn't trust the FDA, health authorities and governmental agencies?
Why would you want to trust anyone who tells you something ludicrous like, "Human papillomaviruses have a label on their foreheads saying 'No entry until sex'" when that is patently, proveably untrue? If FDA can spread such ridiculous comments world-wide, without corrective advice from the scientists who know that isn't true, why would the FDA (or silent scientists) bother with the'truth' when it came to anything else?
Question: So what do I do now?
I don't know. It's your choice. You could vaccinate your child, and see what happens. Does that sound like a good idea? If it doesn't, you better tell your child, because in some countries, they can be vaccinated without your consent!
By Hilary Butler, Contributing Author SANE Vax Inc.
Sources:
http://sanevax.org/
1DNA are genes from the virus - some of which cause infections, and others of which have other functions. The L1 gene strand used to make the vaccine, is specific in that it makes the round ball (envelope) that surrounds the DNA.
2A toxin which sends a red alert danger message to the immune system which says, 'Oi you, there is danger in that locker, go and deal with it.' Without it, the immune system would just yawn and go back to sleep.
3http://users.rcn.com/jkimball.ma.ul...
4http://www.nanoimagingservices.com/...
5http://patft.uspto.gov/netacgi/nph-...
6http://www.fda.gov/downloads/biolog...
About the author:
THE SANE VAX MISSION is to promote Safe, Affordable, Necessary & Effective vaccines and vaccination practices through education and information. We believe in science-based medicine. Our primary goal is to provide the information necessary for you to make informed decisions regarding your health and well-being. We also provide referrals to helpful resources for those unfortunate enough to have experienced vaccine-related injuries.
Articles on this site are written by Norma Erickson, President and Leslie Carol Botha, women's health educator, broadcast journalist and Vice-President Public Relations for SANE Vax, Inc. We also allow content from various contributing authors. Other members include Rosemary Mathis, mother of a Gardasil-injured daughter and Vice President Victim Support; Janny Stokvis, Vice-President Research, Freda Birrell, Secretary and HPV vaccine lobbyist United Kingdom /Scotland, and Linda Thompson, Treasurer.
We are demanding the HPV vaccines be taken off the market until an independent study on their safety and efficacy has been conducted. Until then, we are committing our efforts to an educational media campaign to alert the public about the dangers of the HPV vaccines.
SANE Vax, Inc. is involved in the ground-breaking production of the One More Girl Documentary which will premier in 2012. Please join our cause by contributing to this project by contacting Ryan Richardson, Producer at ryan@onemoregirlfilm.com.
For more information, please visit our site at http://sanevax.org/.
(NaturalNews) If you are considering vaccinating your child with an HPV vaccine, what information have you read, and what questions have you asked?What do you KNOW about the human papillomaviruses (HPV) which the medical profession says causes cervical cancer?
If you are going to vaccinate your child on the word of the medical profession, and don't want any further information, then stop right here. But be aware that ignorance is not bliss. And that the medical system has deliberately not told you everything you need to know about either the viruses, or the vaccine.
If you want to take responsibility for your own decisions, rather than hand over responsibility to the medical profession, then you might be interested in some of the following questions and answers, which deserve truthful answers that the vaccine industry doesn't want to give you:
Question: Publicity for Gardasil says that girls should have this HPV vaccine before sexual intercourse, because they don't catch this virus until they are sexually active. Is this correct?
No, this is not correct. Over the last 20 years, the medical profession has documented that human papillomaviruses can be transmitted during pregnancy, after pregnancy, from child to child, and adult to child.
Question: Why then are we told that these human papillomaviruses can only be contracted after sex?
Because adolescents are the market Merck was targeting, and to admit that the viruses can be acquired naturally before sex, doesn't suit Merck. The medical literature for the last 20 years has also stated that to ignore the fact that HPV viruses can cause silent infection at any age 'has implications for any vaccination programme,' though those 'implications' have never been spelled out. However, they expect parents to naively believe that intelligent human papillomaviruses know they aren't allowed to let themselves loose, until the first act of sexual intercourse. And for some reason, most parents believe this sort of nonsense statement.
Question: Are these viruses implicated in cervical cancers, and other cancers?
Yes they are - but primarily in people, whose innate immune system is struggling because they eat rubbish, drink alcohol, smoke cigarettes, don't get enough sleep, and burn the candle at 12 ends. Much more than a virus is required for a woman to get cervical cancer.
Question: Doesn't everyone get human papillomavirus infections?
Yes. Not only has 'everyone' but just about any species that breathes gets papillomavirus infections - even lizards. The medical literature shows that a good diet, correct mineral and vitamin intake, and living a healthy lifestyle, normally results in the recipient throwing off HP infections easier than a cold, and all they have to show for it, is lifelong natural immunity. Healthy lifestyles don't fill Big Pharma bank balances, so you won't be told about that.
Question: But I've been told this vaccine is so important! Is that wrong
This vaccine is very important for Merck's accountants - vitally important. It's 'the' product that is supposed to dig Merck out of its current financial woes.
But is it important for your child? No. The cervical smear programme stopped people dying of cervical cancer long before 'fear-no-longer' Gardasil came along. And because the vaccine only covers two types out of at least 20 supposedly carcinogenic HP virus types (amongst at least 300 different strains), people who have cancer phobia will still want to have smears anyway. Today, 90% of all deaths from cervical cancer occur in the third world countries which don't have such a programme, or the ability to deal with abnormal smears even if they had a smear programme. The primary drivers of cervical cancer in third world countries are chronic malnutrition, and fundamentally atrocious living conditions, which happens to create the most susceptible population with the least resources.
Question: So why have I been recommended to inject my child with three Gardasil vaccines?
Because if a vaccine is available the medical system tries to scare everyone into using it. After all, it's much easier to 'believe' their assumption that antibodies from Gardasil will still be around 40 years from now. It's much easier not to have to pay attention to diet, and all the other things which would make sure most people never got cancer in the first place.
But the bottom line is that Merck developed Gardasil in the hope that it would be a 'block-buster' vaccine which would help pay for all the litigation Merck faces as the result of another Merck drug, called Vioxx, which maimed and killed lots of people, whose families then turned around and sued Merck for millions of dollars.
Obviously, Merck isn't going to make any money from the third world -the countries that really need it, according to Dr Frazer who co-patented the vaccine. So Merck decided to target all the rich countries that do not need Gardasil. By charging wealthy countries lots of money, then maybe someday about forty years from now..., they might get around to providing it to people in the third world, if they are still around. Which is a bit farcical, when in those countries, what the people could really do with, is decent food, clean water, getting rid of nepotistic dictators and warring tribes, being provided with basic healthcare, and the means of growing their own food... but all that's much too hard. Particularly when Merck's main aim is making money and staying in business.
Question: What is in Gardasil?
According to the data sheet, the vaccine supposedly contains 'no viral DNA1' and each 0.5 mL dose of the vaccine contains:
20 mcg of HPV 6 L1 protein
40 mcg of HPV 11 L1 protein
40 mcg of HPV 16 L1 protein
20 mcg of HPV 18 L1 protein
225 mcg aluminum (as amorphous aluminum hydroxyphosphate sulfate adjuvant2)
9.56 mg of sodium chloride
0.78 mg of L-histidine
50 mcg of polysorbate 80 (shown to induce infertility in mice, which is why it's the main ingredient in depo-provera, and which also makes the brain blood barrier easier to penetrate)
35 mcg of sodium borate
water for injection
Question: What do you mean,'Supposedly'?
Contrary to the manufacturers' documents, the vaccine does actually contain Viral DNA. According to documents filed with Medsafe New Zealand, each vaccine also has a much higher amount of HPV protein than stated on the product insert, in order to ensure that as the vaccine degrades over time, at the END of the shelf life, the vaccine will actually contain the stated dose on the vial.
Question: What do you mean, this vaccine has recombinant HPV viral DNA! What is recombinant HPV viral DNA?
This is where small lengths of genes from two different sources, are combined to make a single recombined length of genes which will perform a specific function.
Question: The New Zealand Government, the manufacturers and all the health authorities not only assured us that there is no DNA, but they say SANE Vax Inc.'s allegations of contamination with DNA are a load of smelly porkies! Explain yourself please?
No-one from the Government, FDA, EMA, or Health Departments have at any time, asked to see the test results of the vaccine, which SANE Vax Inc. commissioned. So, on what basis do they think that the test results are incorrect?
Gardasil was made by taking a DNA sequence (which makes the virus "envelope") from different types of papillomaviruses found in cancerous cervical cells. This viral genetic sequence was then spliced into a plasmid 3 - a circular piece of bacterial DNA (which helps divide the bacterial chromosomes) and allows the HPV DNA to be cloned into yeast. Plasmid DNA also encourages quick manufacture of the 'balls,' by the HPV genes. The genetically engineered mix then makes lots of little empty balls, or 'virus like particles' as seen in photo4 of the Gardasil vaccine.
Then according to Merck's patent5, they have a highly sophisticated process which is supposed to filter out and remove 'contaminating biomolecules, including DNA, lipids and proteins.'
What the test results found, was that some recombinant DNA sequences originating from different types of the virus DNA used to make the vaccine, are still in the vaccine.
Question: What are all those other bits in that photo?
Aluminium, and presumably more mashed up virus like particles. But according to the tests commissioned by SANE Vax Inc., viral DNA used to make those little balls and mashed up pieces, are not removed from Gardasil.
Question: But FDA says that these recombinant DNA are "expected" when using this process. Isn't that true?
No. If those DNA fragments were "expected" components of Gardasil, they would have been listed in the ingredients of the vaccine, and documentation should exist showing why they are a safe and 'essential' ingredient in the vaccine.
Question: How does this fancy patented purification process tell the difference between culture medium DNA, yeast DNA and HPV DNA?
You tell me and we'll both know.
Question: If SANE-vax's tests ARE actually correct, why did a purification process which is supposed to remove DNA lipids, proteins, and biomolecules not work?
I think Merck would like to know the answer to that as well. In the meantime, FDA are covering Merck's butt for them.
Question: But isn't there a final product purity test for Gardasil?
In New Zealand, according to paper work submitted to Medsafe, there are no final purity tests, because Merck believes their filtration process is good enough without them.
Question: But aren't there filtration tests designed to make sure the process is good enough?
According to paper work submitted to Medsafe, there are no filtration "adequacy" tests because Merck believes their process is good enough without them.
Question: Isn't Gardasil made the same way as the Hepatitis B vaccine?
Yes, and according to FDA6 documentation, "Assays for cesium, polysaccharides, DNA, pyrogens and sterility are performed" on the Hepatitis B bulk product. You'd think the same would be done for Gardasil, wouldn't you?
Question: Does the Hepatitis B vaccine also contain genetically engineered, recombinant DNA?
It would appear that the Hepatitis B vaccine could ALSO contain a similar kind of genetically manipulated DNA (in spite of tests to ensure DNA removal). Such recombinant DNA in the Hepatitis B vaccines is also not mentioned in its data sheet or constituent list.
FDA, in its reply to SANE Vax Inc., intimated that Hepatitis B vaccine also contains recombinant DNA, and that such unstated DNA was quite "acceptable". So they are covering Merck's butt for that as well.
Question: FDA says these particles are no big deal because they can't cause infection. Is that true?
No it's not. The point of a vaccine is to form antibodies to various substances called "antigens" in the vaccine. DNA doesn't have to cause infection to spell trouble. Because the recombinant DNA is tightly bound to the aluminium, the aluminium turns the DNA into an 'antigen,' something the immune system has to react to. But an abnormal immune response, especially to an aluminium-bound DNA, could result in antibodies which cross react and turn against healthy DNA. That could cause autoimmune disease, brain inflammation, joint inflammation, and major disruption to energy pathways, hormone functions and a vast array of other biological pathways, which normally keep an adolescent healthy, physically and mentally.
Question: But FDA says that Gardasil is very safe and doesn't cause anything more than a sore arm. Isn't that true?
No. America's FDA and all medical authorities say that all vaccines are safe apart from sore arms, and that everything else that happens after a vaccine is a coincidence..., and anyone who says otherwise, needs their head looked at.
FDA monitors all vaccines by using a system called VAERS, short for the Vaccine Adverse Event Reporting System, which is known to only collect 10% of reactions at most, and reporting is voluntary, not mandatory. On the one hand, they 'consult' this system, but on the other, they consider that all reactions sent to this system have nothing to do with the vaccine at all. So in terms of a monitoring system, they might as well not have one at all. In fact, they might as well do away with it altogether, since to them, the fact that Gardasil reports comprise 20% of all reported reactions appears to them to be some fabricated nuisance. It doesn't seem to occur to the FDA, that perhaps there is something badly wrong with this 'lovely safe' vaccine, which their crystal ball says will prevent your child from having cervical cancer, by the (average) age of 54.
Question: Are you telling me, I shouldn't trust the FDA, health authorities and governmental agencies?
Why would you want to trust anyone who tells you something ludicrous like, "Human papillomaviruses have a label on their foreheads saying 'No entry until sex'" when that is patently, proveably untrue? If FDA can spread such ridiculous comments world-wide, without corrective advice from the scientists who know that isn't true, why would the FDA (or silent scientists) bother with the'truth' when it came to anything else?
Question: So what do I do now?
I don't know. It's your choice. You could vaccinate your child, and see what happens. Does that sound like a good idea? If it doesn't, you better tell your child, because in some countries, they can be vaccinated without your consent!
By Hilary Butler, Contributing Author SANE Vax Inc.
Sources:
http://sanevax.org/
1DNA are genes from the virus - some of which cause infections, and others of which have other functions. The L1 gene strand used to make the vaccine, is specific in that it makes the round ball (envelope) that surrounds the DNA.
2A toxin which sends a red alert danger message to the immune system which says, 'Oi you, there is danger in that locker, go and deal with it.' Without it, the immune system would just yawn and go back to sleep.
3http://users.rcn.com/jkimball.ma.ul...
4http://www.nanoimagingservices.com/...
5http://patft.uspto.gov/netacgi/nph-...
6http://www.fda.gov/downloads/biolog...
About the author:
THE SANE VAX MISSION is to promote Safe, Affordable, Necessary & Effective vaccines and vaccination practices through education and information. We believe in science-based medicine. Our primary goal is to provide the information necessary for you to make informed decisions regarding your health and well-being. We also provide referrals to helpful resources for those unfortunate enough to have experienced vaccine-related injuries.
Articles on this site are written by Norma Erickson, President and Leslie Carol Botha, women's health educator, broadcast journalist and Vice-President Public Relations for SANE Vax, Inc. We also allow content from various contributing authors. Other members include Rosemary Mathis, mother of a Gardasil-injured daughter and Vice President Victim Support; Janny Stokvis, Vice-President Research, Freda Birrell, Secretary and HPV vaccine lobbyist United Kingdom /Scotland, and Linda Thompson, Treasurer.
We are demanding the HPV vaccines be taken off the market until an independent study on their safety and efficacy has been conducted. Until then, we are committing our efforts to an educational media campaign to alert the public about the dangers of the HPV vaccines.
SANE Vax, Inc. is involved in the ground-breaking production of the One More Girl Documentary which will premier in 2012. Please join our cause by contributing to this project by contacting Ryan Richardson, Producer at ryan@onemoregirlfilm.com.
For more information, please visit our site at http://sanevax.org/.
Health Authorities Admit Gardasil™ Contains Residual Recombinant HPV DNA
October 14, 2011 By Norma
By Norma Erickson, President
2 September 2011, SANE Vax Inc. posted a letter sent to Dr. Margaret Hamburg, FDA Commissioner, on their website to inform her that recombinant (genetically modified) HPV DNA firmly attached to the aluminum adjuvant had been discovered in Merck’s quadrivalent HPV vaccine, Gardasil™.
In what appears to be a worldwide coordinated response, SANE Vax Inc. and other advocacy groups have received the following replies:
22 September 2011, the European Medicines Agency, via Dr. Abadie said, “The presence of recombinant DNA fragments does not represent a case of contamination and is not considered to be a risk to vaccine recipients. All medicinal products manufactured using recombinant technology may contain small fragments of residual DNA.”
23 September 2011, the Food and Drug Administration (FDA) said, “We have determined that Gardasil is not contaminated with HPV DNA and remains safe and effective….Gardasil does contain recombinant HPV L1 specific DNA fragments. This is expected, since DNA encoding the HPV L1 gene is used in the vaccine manufacturing process to produce the virus-like particles. The presence of these expected DNA fragments, which are inevitable in vaccine production, is not a risk to vaccine recipients, is not harmful, and this DNA is not a contaminant.”
28 September 2011, MedSafe in New Zealand, via email to a local vaccine safety advocate said, “Gardasil is manufactured using recombinant DNA technology so any finding of residual DNA fragments in the vaccine is expected and does not represent contamination.”
7 October 2011, the Queensland Immunisation Program in Australia, via email to an Australian advocate, said, “Gardasil is manufactured using recombinant DNA technology so any finding of residual DNA fragments in the vaccine is expected and does not represent contamination.”
The above statements are all in direct contradiction to the following documentation used on a world-wide basis to either approve, and/or market Gardasil™:
From the United Kingdom: HPV vaccines are sub-unit vaccines made from the major protein of the viral-coat or capsid of HPV.Virus-like particles (VLPs) are prepared as recombinant proteins from either yeast or baculovirus infected cells that are derived from a type of moth. VLPs mimic the structure of the natural virus but do not contain any viral DNA.
From the FDA: “GARDASIL® is not a live virus vaccine; it contains no viral DNA, and is therefore incapable of causing infection.”
From Australia: “GARDASIL contains HPV 6, 11, 16 and 18 L1 VLPs. Each VLP is composed of a unique recombinant L1 major capsid protein for the respective HPV type. Because the virus-like particles contain no viral DNA, they cannot infect cells or reproduce.”
From the Gardasil Access Program: “GARDASIL® is not a live virus vaccine; it contains no viral DNA, and is therefore incapable of causing infection.”
To date, all health agencies responding to the SANE Vax announcement of Gardasil™ contamination have completely ignored the fact that the residual HPV DNA is firmly attached to the aluminum adjuvant. Furthermore, no regulatory authority, anywhere, has asked to see the detailed genetic sequences contained in the laboratory results, in order to ask their own laboratories to confirm the Genbank DNA sequences found.
It is important to note that every single time the SANE Vax team communicates with any health ‘authority’ our claims are backed up and referenced with peer-reviewed published scientific studies, data from the manufacturer, or data from government sponsored health agencies. When a response is received, there is no evidence to back up the health agency’s position.
Where does this leave medical consumers? Medical consumers around the world are no longer satisfied with a simple ‘pat on the head’ and ‘assurances’ that vaccines are safe and effective. They demand and deserve scientific proof.
If parents of the Gardasil™ victims had been fully informed of all the risks and limited benefits of Gardasil™, including the presence of recombinant DNA in the vaccine which may cause autoimmune-based disorders, immediate death, or permanent disabilities, they might have been able to make an informed decision. They could have made an informed choice as to whether it was better for their children to risk immediate negative outcomes with a vaccine, or to teach their children about an already proven safe and effective method of controlling cervical cancer, namely regular screening and good gynecological care.
It is time for the manufacturers of HPV vaccines and government health agencies involved to provide scientifically sound proof that residual recombinant HPV DNA firmly attached to an aluminum adjuvant presents no current or future health risk to the children and young adults of the world.
When injecting a healthy population to attempt to control a disease that may occur 40 years down the road in a population that has limited or no access to good gynecological care, there is no excuse for taking on any additional risk involved with vaccination.
Until such time as documented scientific proof is provided, all potentially contaminated vaccines should be withdrawn from the market. Anything less deprives parents around the world of their right to informed consent when making healthcare decisions for their children.
Please visit our site at http://sanevax.org/.
By Norma Erickson, President
2 September 2011, SANE Vax Inc. posted a letter sent to Dr. Margaret Hamburg, FDA Commissioner, on their website to inform her that recombinant (genetically modified) HPV DNA firmly attached to the aluminum adjuvant had been discovered in Merck’s quadrivalent HPV vaccine, Gardasil™.
In what appears to be a worldwide coordinated response, SANE Vax Inc. and other advocacy groups have received the following replies:
22 September 2011, the European Medicines Agency, via Dr. Abadie said, “The presence of recombinant DNA fragments does not represent a case of contamination and is not considered to be a risk to vaccine recipients. All medicinal products manufactured using recombinant technology may contain small fragments of residual DNA.”
23 September 2011, the Food and Drug Administration (FDA) said, “We have determined that Gardasil is not contaminated with HPV DNA and remains safe and effective….Gardasil does contain recombinant HPV L1 specific DNA fragments. This is expected, since DNA encoding the HPV L1 gene is used in the vaccine manufacturing process to produce the virus-like particles. The presence of these expected DNA fragments, which are inevitable in vaccine production, is not a risk to vaccine recipients, is not harmful, and this DNA is not a contaminant.”
28 September 2011, MedSafe in New Zealand, via email to a local vaccine safety advocate said, “Gardasil is manufactured using recombinant DNA technology so any finding of residual DNA fragments in the vaccine is expected and does not represent contamination.”
7 October 2011, the Queensland Immunisation Program in Australia, via email to an Australian advocate, said, “Gardasil is manufactured using recombinant DNA technology so any finding of residual DNA fragments in the vaccine is expected and does not represent contamination.”
The above statements are all in direct contradiction to the following documentation used on a world-wide basis to either approve, and/or market Gardasil™:
From the United Kingdom: HPV vaccines are sub-unit vaccines made from the major protein of the viral-coat or capsid of HPV.Virus-like particles (VLPs) are prepared as recombinant proteins from either yeast or baculovirus infected cells that are derived from a type of moth. VLPs mimic the structure of the natural virus but do not contain any viral DNA.
From the FDA: “GARDASIL® is not a live virus vaccine; it contains no viral DNA, and is therefore incapable of causing infection.”
From Australia: “GARDASIL contains HPV 6, 11, 16 and 18 L1 VLPs. Each VLP is composed of a unique recombinant L1 major capsid protein for the respective HPV type. Because the virus-like particles contain no viral DNA, they cannot infect cells or reproduce.”
From the Gardasil Access Program: “GARDASIL® is not a live virus vaccine; it contains no viral DNA, and is therefore incapable of causing infection.”
To date, all health agencies responding to the SANE Vax announcement of Gardasil™ contamination have completely ignored the fact that the residual HPV DNA is firmly attached to the aluminum adjuvant. Furthermore, no regulatory authority, anywhere, has asked to see the detailed genetic sequences contained in the laboratory results, in order to ask their own laboratories to confirm the Genbank DNA sequences found.
It is important to note that every single time the SANE Vax team communicates with any health ‘authority’ our claims are backed up and referenced with peer-reviewed published scientific studies, data from the manufacturer, or data from government sponsored health agencies. When a response is received, there is no evidence to back up the health agency’s position.
Where does this leave medical consumers? Medical consumers around the world are no longer satisfied with a simple ‘pat on the head’ and ‘assurances’ that vaccines are safe and effective. They demand and deserve scientific proof.
If parents of the Gardasil™ victims had been fully informed of all the risks and limited benefits of Gardasil™, including the presence of recombinant DNA in the vaccine which may cause autoimmune-based disorders, immediate death, or permanent disabilities, they might have been able to make an informed decision. They could have made an informed choice as to whether it was better for their children to risk immediate negative outcomes with a vaccine, or to teach their children about an already proven safe and effective method of controlling cervical cancer, namely regular screening and good gynecological care.
It is time for the manufacturers of HPV vaccines and government health agencies involved to provide scientifically sound proof that residual recombinant HPV DNA firmly attached to an aluminum adjuvant presents no current or future health risk to the children and young adults of the world.
When injecting a healthy population to attempt to control a disease that may occur 40 years down the road in a population that has limited or no access to good gynecological care, there is no excuse for taking on any additional risk involved with vaccination.
Until such time as documented scientific proof is provided, all potentially contaminated vaccines should be withdrawn from the market. Anything less deprives parents around the world of their right to informed consent when making healthcare decisions for their children.
Please visit our site at http://sanevax.org/.
Wednesday, October 5, 2011
Dr. Sin Hang Lee: A case study in ethics don’t pay
October 4, 2011
By Norma Erickson, President
SANE Vax Inc. was organized to provide medical consumers with all of the information they need to make informed choices about vaccines, HPV vaccines in particular. Dr. Sin Hang Lee, Director of Milford Medical Laboratory Inc. has been instrumental in our efforts to raise consumer awareness regarding safe and effective cervical cancer prevention and the scientific facts in relation to the international HPV vaccine controversy.
Because of studies submitted to the FDA prior to approval of HPV vaccines indicating there was a substantial increase in pre-cancerous lesions for those who had already been exposed to vaccine-relevant genotypes of HPV before they were injected with Gardasil® or Cervarix®, Dr. Lee agreed to offer his cutting edge technology HPV genotyping test to medical consumers throughout the United States to protect those who were considering HPV vaccination so they could avoid that potential risk. The decision was announced to the public via a BusinessWire Press Release on 20 September 2010.
In the fall of 2010, without Dr. Lee’s knowledge or having an opportunity to defend himself, the newly appointed Chairperson of the Pathology Department at Milford Hospital informed the hospital’s credentialing committee that she was not recommending for approval or supporting Dr. Lee’s application for renewal of his medical staff privileges. For those who do not know, medical staff privileges at a hospital are a major asset to a medical doctor and they establish the relationship that permits among other things, the doctor to practice at a particular hospital. When medical staff privileges at a hospital are revoked or not renewed, the doctor no longer has permission to practice at the hospital or use its facilities. The non-renewal of the medical staff privileges, may also adversely affect the doctor’s license to practice medicine. In Dr. Lee’s case, the non-renewal of his medical staff privileges at Milford Hospital is under appeal.
Although Dr. Lee still maintains his medical staff privileges during the appeal, his position as director of the laboratory was summarily terminated along with his employment relationship at Milford Hospital on December 13, 2010 and he has been prevented from using the hospital’s laboratory to continue his testing and research there ever since that time. A lawsuit addressing the wrongful termination claim has been brought against the Milford Hospital.
While the hospital-based appeal hearings and the lawsuit are pending, Dr. Lee’s research and testing and the operation of his world class, CLIA certified molecular diagnostic laboratory at the Milford Hospital have all been significantly hindered and obstructed. Dozens of opportunities for Dr. Lee to test Gardasil samples for contaminants have been lost as the hospital has redirected and/or returned vaccine lots sent to and intended for Dr. Lee back to the senders or other locations. Dr. Lee and his attorneys are pursuing all available legal remedies to restore the testing laboratory as soon as possible in order to protect the public health, safety and well being.
In addition to his efforts to make sure those who choose to use HPV vaccines are able to protect themselves from a potential increased risk of pre-cancerous lesions due to prior exposure to vaccine-relevant HPV, Dr. Lee also allowed SANE Vax Inc. to offer his HPV DNA sequencing technology to those unfortunate enough to have experienced abnormal pap tests after HPV vaccination. SANE Vax Inc. believes these medical consumers have a right to know what genotypes of HPV are associated with their abnormal cells. If they are vaccine-relevant genotypes, the vaccine did not work for them. If they are not vaccine-relevant genotypes, perhaps the manufacturer targeted the wrong genotypes for their geographic area. Either way, medical consumers have a right to know.
Through the donation of his laboratory facilities, time and effort, Dr. Lee was able to confirm the contamination of Gardasil® with recombinant HPV DNA firmly attached to the aluminum adjuvant contained in the vaccine. This is a man who has dedicated his life to what is best for the medical consumer, no matter what the cost to himself personally.
It is the belief of the SANE Vax team that Dr. Lee has come under fire because of his association with and support for the SANE Vax mission. Therefore, the SANE Vax Board of Directors is beginning a campaign to let those in charge of deciding Dr. Lee’s fate know that we, along with medical consumers around the world, support Dr. Lee.
If you wish to join us to show your support for Dr. Lee and his ability to continue his much needed research, please take a few minutes to send the following three emails to the authorities in charge of determining Dr. Lee’s fate:
#1 Dr. Joe Pellacia, President and CEO, Milford Medical Hospital
#2 Commissioner Jewel Mullen, Connecticut Department of Public Health
#3 Mr. George Jepsen, Attorney General State of Connecticut
All you need do is copy the linked emails into a new email, add an introductory sentence if you wish, and type your name and state/country after the signature line.
Without the information provided by Dr. Lee and his ongoing research, we feel medical consumers around the world will be deprived of information that is vital to their ability to exercise their right to informed consent when it comes to HPV vaccinations.
Please, take a few minutes and show those in charge of deciding Dr. Lee’s fate that you support his efforts to do what is best for medical consumers.
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