Posted: 11/17/2015 5:30:38 PM
Following is a public comment made by Barbara Loe Fisher, NVIC Co-founder & President, at the Nov. 13, 2015 meeting of the FDA Vaccines & Related Biological Products Advisory Committee (VRBPAC) on proposed changes to FDA requirements for licensure of vaccines intended for use during pregnancy
Birth defects, chromosomal damage, premature birth, low birth weight, pregnancy complications and sudden infant death syndrome, not infectious diseases, are the leading causes of death for about 23,000 infants dying before their first birthday in the US every year, with half of those deaths occurring on the first day of life. 1 2 Women getting pregnant and delivering babies in America today have more than twice the risk of dying during pregnancy, childbirth or within one year of giving birth than they did three decades ago, with heart failure, high blood pressure and stroke, diabetes, and blood clots being among the leading causes of death. 3 4
In 2006, CDC officials directed doctors to give all pregnant women a flu shot 5 and, in 2011, a Tdap shot during every pregnancy, no matter how little time has elapsed between pregnancies. 6 Prior to FDA licensure, influenza, diphtheria, tetanus and pertussis vaccines were not tested in or proven safe and effective for pregnant women in large clinical trials when given during every pregnancy either singly or simultaneously. 7 8
Categorized by FDA as Pregnancy Category B and C biologicals 9 because it is not known whether the vaccines are genotoxic and can cause fetal harm or can affect maternal fertility and reproduction, administering influenza and Tdap vaccines to pregnant women is an off-label use of these vaccines. 10 11 12 It is a policy that assumes maternal vaccination is necessary, safe and effective without proving it. 13
Tdap vaccine was licensed by FDA as a single dose pertussis booster shot in individuals over 10 or 11 years old, and pertussis containing vaccine injuries and deaths are the most compensated claim in the federal vaccine injury compensation program (VICP) for infants and children, while influenza vaccine-related injuries and deaths are the most compensated claim for adults. 14 And yet, in the absence of credible biological mechanism and epidemiologic evidence pre-licensure proving these vaccines are safe for all pregnant women, their fetuses and newborns, female health care workers are being fired for refusing to be injected with them while they are pregnant. 15
This maternal vaccination policy is a violation of the precautionary principle to “first, do no harm,” 16 and it is of grave concern to women having babies in America, especially pregnant health care workers. When federal vaccine use recommendations are being turned into laws that punish Americans refusing to obey them with denial of a school education, medical care and employment, 17 18 maintaining high FDA vaccine licensing standards is absolutely essential.
There have been no well designed prospective, long term case controlled studies enrolling large groups of American women who get influenza and Tdap vaccines during pregnancy and comparing their health and the viability of their fetuses and newborns to women who do not get vaccinated. There are no published studies to identify unresolved vaccine-induced inflammation in the brains and bodies of the fetus, mother and newborn; or to measure atypical changes in brain and immune function and chromosomal integrity, including evaluating the numbers of de novo mutations present before and occurring after vaccination.
Maternal vaccination policy has preceded vaccine safety science. Now, there are proposals on the table here in this Committee and in the 21st Century Cures Act backed by FDA and industry to lower FDA licensing standards to ensure that vaccine policy can continue to precede vaccine safety science in the future. 19 Considerable discussion today about making a priori assumptions that complications and fetal death following maternal vaccination are only coincidentally and not causally related to vaccination 20 is a big red flag for vaccine consumers in the absence of credible pathological evidence to conclusively determine what is and is not vaccine induced.
The National Vaccine Information Center is opposed to FDA retroactively licensing influenza and Tdap vaccines for use in pregnant women and fast tracking RSV 21 and group strep B 22 vaccines to licensure by using small clinical trials; adaptive trial designs; Baysian methods of data analysis; biomarkers and surrogate endpoint measures rather than actual clinical endpoints; or using clinical experience instead of good bench science and randomized controlled clinical trials with long term follow-up to prove effectiveness and safety.
The fact that vaccine manufacturers, regulators, policymakers and providers are completely shielded from civil liability for vaccine injuries and deaths 23 makes it even more important for FDA standards for proof of vaccine safety and effectiveness to be very high, especially when licensing vaccines targeting pregnant women and their unborn babies.
Posted: 11/2/2015 10:02:12 AM
By Barbara Loe Fisher
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Three decades ago, Congress created a federal vaccine injury compensation program (VICP) and gave the pharmaceutical and medical trade industries a partial product liability shield under the National Childhood Vaccine Injury Act of 1986. The goal was simple: to restrict civil lawsuits against vaccine manufacturers and negligent doctors whenever government mandated vaccines injure and kill Americans. 1
In the 21st century, Congress went further and directed federal agencies to develop a public-private business partnership with the pharmaceutical industry. 2 3 Today, multi-national corporations marketing vaccines enjoy a $15 billion dollar U.S. and $30 billion dollar global vaccine market that will reach $100 billion in 10 years. 4 5
At the same time, Congress appropriates billions of U.S. taxpayer dollars to federal agencies working with Big Pharma to develop hundreds of new vaccines, 6 7 while vaccine licensing standards have been lowered so companies can fast-track experimental vaccines to market. 8 9 Meaningful congressional oversight on vaccine regulation and policymaking is non-existent today, in part because the pharmaceutical industry is the number one wealthiest and most powerful lobby on Capitol Hill. 10 11 12 13
Obtaining Vaccine Injury Compensation: Do You Feel Lucky?
Parents, who file a claim today on behalf of a brain damaged vaccine injured child in the federal vaccine injury compensation program (VICP) under the 1986 Act, know that the odds of obtaining financial assistance from the government are not much better than the odds of winning a lottery. 14 Department of Health and Justice officials fight almost every award in the U.S. Court of Claims so two out of three vaccine injury claims are denied. 15
Parents already traumatized because their healthy child was permanently disabled or died after receiving a government licensed pharmaceutical product they were promised would keep their child well, are traumatized again in what has become a highly adversarial and lengthy process that too often ends in disbelief, anger and heartbreak.
Government Officials Gut 1986 NCVIA and Betray Public Trust
Congress created the National Childhood Vaccine Injury Act (NCVIA) in 1986 as a social contract between government and parents, who are required under state vaccine laws to give their children federally recommended vaccines in order to attend school. Since 1995, the vaccine injury compensation program set up under the National Childhood Vaccine Injury Act has been systematically gutted by government officials, who vigorously opposed passage of the law in 1986 16 and have been determined to destroy it ever since.
After the U.S. Supreme Court in 2011 effectively completely shielded the pharmaceutical industry from all civil liability for injuries and deaths caused by FDA licensed vaccines, 17 there has been no legal accountability for any corporation or individual who develops, licenses, recommends, promotes, administers or mandates vaccines that injure and kill Americans.
The history of the National Childhood Vaccine Injury Act is one that has been marked by a profound betrayal of the public trust by government. At the center of that betrayal are doctors and scientists working for government and with industry, who are so determined to deny vaccine risks and cover up the casualties of one-size-fits-all vaccine policies, that they will throw innocent children under the bus to do it.
Toxic DPT Vaccine Brain Injures Children
I remember walking the halls of Congress in 1982 with other young parents of DPT vaccine injured children asking for a congressional investigation into the safety of the old whole cell pertussis vaccine. We did not understand why federal health agencies had not required drug companies to make that crude vaccine less toxic. We wanted to know why our babies did not have access to the less reactive new split cell pertussis vaccine in the DTaP shot that Japan was giving their children using technology developed in the 1970’s. 18
We knew that the 1981 British National Childhood Encephalopathy Study revealed that 1 in 110,000 DPT shots was followed by brain inflammation and 1 in 310,000 DPT shots by permanent brain damage. 19 We knew another prospective, case controlled study published in the U.S. the same year revealed convulsions occurred after 1 in 875 DPT shots and a collapse shock reaction occurred after 1 in 875 DPT shots, meaning that at least 18,000 children in America were either having convulsions or collapsing after DPT shots. 20 21
But Centers for Disease Control (CDC) officials did not know who those children were because pediatricians were not required to report vaccine reactions, or inform parents about how to monitor children for signs and symptoms of vaccine reactions, or keep permanent records of vaccines given, or write down serious health problems following vaccination in medical records.
Big Pharma Demands Liability Protection from Vaccine Injury Lawsuits
Back in the 1970’s and 80’s, parents were filing product liability lawsuits against the three drug companies selling DPT vaccine and also against one selling live oral polio vaccine after children were paralyzed by vaccine strain polio. Parents were also filing malpractice lawsuits against pediatricians when their babies were re-vaccinated after reacting to previous DPT shots with convulsions, shock, high pitched screaming and unconsciousness, which can be signs of brain inflammation or encephalopathy, 22 a well known complication of vaccination since the first vaccines for smallpox and rabies were used in the 19th century. 23
Thirty years ago, high-powered attorneys for pharmaceutical corporations and pediatricians were blackmailing parents on the courthouse steps before jury trials began to settle vaccine injury lawsuits without going to trial. Few parents had the financial resources to battle big drug companies in court for long periods of time and so many would settle for low sums of money just before the trial began. As part of the settlement, parents had to agree that all court documents about their child’s vaccine injury would be sealed and blocked from public view.
I was among the parents of DPT vaccine injured children, who organized after watching the Emmy award winning TV documentary DPT: Vaccine Roulette in the spring of 1982. We accepted the invitation by congressional leaders taking action after the four drug companies marketing childhood vaccines in the U.S. (Wyeth, Lederle, Merck and Connaught) told Congress they would stop distributing the federally recommended and state mandated DPT, polio and MMR vaccines if Congress refused to give them a liability shield from vaccine injury lawsuits. 24
Vaccine Injury Compensation: “Simple Justice for Children?”
In an era when people communicated with each other on land lines and through the mail because there was no internet, email, personal computers or cell phones, parents of vaccine injured children fought as hard as we could to protect the legal right to sue pharmaceutical corporations for vaccine injuries and deaths under the National Childhood Vaccine Injury Act, which was the solution Congress came up with in response to threats by the pharmaceutical industry. The American Academy of Pediatrics (AAP) called the federal vaccine injury compensation program “simple justice for children.” Politicians said it would be a safety net for every child when vaccine risks turn out to be 100 percent. 25
We were promised that the program would be a non-adversarial, expedited, less traumatic and less expensive administrative alternative to a lawsuit – not an exclusive legal remedy that prohibited all product liability lawsuits against vaccine manufacturers.
We believed that Congress would keep the promises made to parents when it gave partial liability protection to the pharmaceutical industry producing vaccines and the medical trade industry representing pediatricians. We believed that the informing, reporting and recording vaccine safety provisions, which the co-founders of the National Vaccine Information Center (NVIC) were specifically responsible for securing into that law, would be enforced. 26
Parents Trusted Congress Would Enforce 1986 Vaccine Injury Act
We trusted that Congress would make sure drug companies and federal health agencies would conduct biological mechanism research to identify high risk children and improve vaccine safety, and that all pediatricians and vaccine providers would be required to obey vaccine safety provisions to:
- give parents written information about infectious diseases, vaccines and how to identify vaccine reactions before their children were vaccinated; and
- enter reactions and serious health problems developing after vaccination into the child’s permanent medical record; and
- keep a record of all vaccines given, including the manufacturer’s name and lot number; and
- file a report with the federal vaccine adverse event reporting system (VAERS) when a child suffered vaccine reaction symptoms and serious health problems, was hospitalized or died after vaccination.
Government Has Broken VICP Social Contract with Parents
Every one of the promises made to parents 30 years ago in that social contract have been broken, and “simple justice for children” has turned out to be a lie. Over the past three decades, government agencies and their pharmaceutical and medical trade industry partners have turned the National Childhood Vaccine Injury Act into a drug company stockholder’s dream and a parent’s worst nightmare.
Government Targets Pertussis Vaccine Injured Children
Now, in a desperate attempt to convince the public that vaccines are the only class of pharmaceutical product in the history of pharmacology completely free of serious side effects, 27 28 the genetically defective label is being slapped on children who suffer brain inflammation and permanent brain damage after vaccination. 29 Even though scientists have known for more than a century that vaccines can cause seizures 30 and brain inflammation (encephalitis/encephalomyelitis) 31 32 33 and permanent brain damage, also called encephalopathy, 34 35 doctors working for government and with industry want to pretend that vaccines containing lab altered bacteria and live viruses, toxins, chemicals, foreign DNA and other contaminants 36 do not brain damage anyone, especially healthy infants.
Children who become brain damaged after receiving pertussis-containing vaccines (like DPT and DTaP) are especially being targeted in a blatant effort to rewrite history and cover up vaccine risks and failures. 37 38 Perhaps that is because, among the $3 billion dollars in federal vaccine injury compensation awarded over the past 27 years under the National Childhood Vaccine Injury Act of 1986, the majority of awards for children have been for pertussis-containing vaccine injuries and deaths. 39
The reason for that is because there is a substantial amount of biological mechanism and epidemiological evidence in the medical literature that pertussis vaccine is, indeed, causally related to encephalitis and chronic neurological dysfunction in both animals 40 41 42 and humans 43 44 45 46 47 48 In fact, pertussis toxin, a component of pertussis vaccine, as well as pertussis vaccine itself, have been used by lab researchers for decades to reliably stimulate experimental autoimmune encephalomyelitis in mice and rats. 49 50 51
“Unavoidably Unsafe” Vaccines 100% Safe?
Even though Congress and the U.S. Supreme Court have declared that FDA licensed vaccines are “unavoidably unsafe” for the purpose of banning product liability lawsuits against drug companies, 52 53 54 government officials still want you to believe that vaccines are 100 percent safe for you, your children and everyone you know 100 percent of the time. The “It’s your fault, not the fault of our vaccines” defense is the ultimate free pass the pharmaceutical and medical trade industries are determined to get so they can keep on telling lies like it would be safe to give babies 10,000 vaccines at once 55 to justify forcing one-size-fits-all vaccine policies on all children and adults – no exceptions and no questions asked. 56
The utilitarian “greater good” argument only works if nobody is held accountable for the individuals being sacrificed in the name of the greater good.
Health Officials Blame Spontaneous Genetic Mutations for Vaccine Injuries
The newest ploy is to allege that if a child’s health suddenly deteriorates after vaccination, especially after pertussis vaccination, it is caused by unavoidable de novo – that’s a Latin word for “new ‘‘ - genetic mutations the child probably did not inherit but spontaneously developed at some point in his or her life. 57 58
That’s right. Government officials and the hired guns they pay with your taxpayer dollars want you to believe that if your child was developing normally before getting three or six or 10 government mandated vaccines on the same day (especially pertussis containing vaccines) and then has a seizure and develops encephalopathy within hours or days of getting those vaccines, your child was predestined to become brain injured at that moment in time, even if no vaccines had been given. 59 60
The government’s “it’s your fault” causation theory goes like this: since public health officials believe it was your child’s destiny to develop random new mutations that cause chronic brain dysfunction, no vaccine injury compensation is to be awarded because the vaccines didn’t do it; the vaccine manufacturer selling the vaccines didn’t do it; the federal health officials who licensed and recommended the vaccines didn’t do it; the state health officials and legislators who voted to mandate the vaccines didn’t do it; the doctor giving the vaccines didn’t do it – you and your child’s spontaneously defective genes did it.
So you and your child are on your own.
Pertussis Vaccine Injured Children Denied VICP Awards
And this is already happening. Normally developing children who have experienced seizures and other signs of encephalopathy within hours or days of vaccination, especially after being injected with pertussis containing vaccines (DTaP), 61 are being denied vaccine injury compensation because government officials argue that vaccinations simply “triggered” the brain deterioration process and the child’s spontaneously defective genes are solely to blame. 62 63 64 65 66 67 And now when a special master in the U.S. Court of Claims does award compensation for a pertussis vaccine injury, it is appealed by the government so that financial assistance is taken away from the child and parents raising their vaccine handicapped child. 68
But not all children with de novo genetic mutations go on to develop seizure disorders and brain dysfunction. A normally developing child might have continued to develop normally for many years if the pertussis vaccine or other vaccines had not been given, but doctors do not screen children for genetic susceptibility before vaccinating them. 69
NCVIA of 1986 Says Susceptible Children Should Be Compensated
The National Childhood Vaccine Injury Act specifies that children with pre-existing conditions made worse after vaccination are not disqualified from receiving vaccine injury compensation. 70 71 That is because susceptible children with underlying health conditions, who develop catastrophic brain injuries after receiving government recommended and mandated vaccines, are precisely the ones who should be the first to be awarded uncontested federal vaccine injury compensation!
We All Have Unique Genetic, Biological, Environmental Differences
Public health officials are well aware that we are all unique individuals and that there are genetic, biological and environmental differences among us, including those that increase our susceptibility to prescription drug and vaccine reactions. 72 73 74 75 76 77 Scientists do not know how, why or when genetic mutations spontaneously occur and cause harm. 78 79 80
Environmental exposures are thought to play a key role in “de novo” genetic mutations, but they are still unexplained in part because the complex science of epigenetics is still in its infancy. Scientists are just beginning to understand that our health is not only affected by the genes we inherit from our parents; our genes are turned on and off and mutate due to environmental exposures and health choices our parents and grandparents made and that we are exposed to our make during our own life. 81 82 83 84 85
Dravet Syndrome: Susceptibility to Seizures After Vaccination
Children diagnosed with Dravet syndrome, 86 87 for example, have a rare de novo genetic mutation that predisposes them to develop medication resistant seizures and subsequent brain damage and an estimated 2.5 percent of children who develop seizures after vaccination carry the mutation. 88 89 90 Those children are often perfectly healthy until they experience their first seizure – with or without fever – after a round of vaccinations. 91 92
And yet, children in the U.S. are not being screened for Dravet or any other genetic susceptibility that can trigger seizures and other reactions before doctors give them vaccines. 93 In fact, some doctors insisting on “no exceptions” vaccine use policies have insisted that children with Dravet continue to be vaccinated on schedule even after they develop vaccine-related seizure disorders. 94 They are the same doctors alleging that vaccines do not cause brain damage just because a small percentage of children with de novo mutations associated with Dravet syndrome develop seizures after vaccination! 95
No Science Evaluating the Vaccine Schedule Or Genetic Mutations After Vaccination
The 1986 law requires the Secretary of DHHS to:
(1) “promote the development of childhood vaccines that result in fewer and less serious adverse reactions than those on the market on Dec. 22, 1987, and promote the refinement of such vaccines;” and
(2) “to make or assure improvements in, and otherwise use the authorities of the Secretary with respect to, the licensing, manufacturing, processing, testing, labeling, warning, use instructions, distribution, storage, administration, field surveillance, adverse reaction reporting, and recall of reactogenic lots or batches, of vaccines, and research on vaccines, in order to reduce the risks of adverse reactions to vaccines.” 96
After 30 years, why has Congress failed to enforce that clarion call for research to reduce the risks of adverse reactions to vaccines?
Where is the biological mechanism research measuring changes in immune and brain function at the cellular and molecular level when vaccines cause injury and death?
Where are the pathological profiles to help doctors and coroners separate “coincidence” from vaccine induced brain injury and death?
Where are the studies investigating whether genetic mutations are occurring in a fetus or a pregnant woman after four vaccines are given during the first trimester; or after newborns are given a dose of hepatitis B vaccine on the first day of life; or after a baby has been given 24 vaccinations by age six months; or after a two year old has been given a total of 45 government recommended vaccinations?
Where is the basic science research to compare de novo mutations and chromosomal damage in children and adults before and after vaccination?
Clearly, that knowledge is not important to public health officials and doctors, who have not conducted methodologically sound studies proving that the federal childhood vaccine schedule of 69 doses of 16 vaccines is safe. 97 The refusal by government to compare long-term health outcomes of vaccinated and unvaccinated children to find out exactly who is genetically more susceptible to suffering vaccine harm and if there are differences in the numbers of de novo genetic mutations experienced by vaccinated and unvaccinated children, is indefensible.
NVIC Submits Statements on VICP to GAO and ACCV
In November 2014, the Government Accountability Office (GAO) published a report for Congress that affirmed what parents of vaccine injured children have been saying for years. 98 Part of that GAO report included information provided by the National Vaccine Information Center in a July 2014 referenced statement submitted to GAO. 99
In September 2014, NVIC additionally submitted a referenced statement to the Advisory Commission on Childhood Vaccines (ACCV) protesting the systematic gutting of the definition of encephalopathy and Vaccine Injury Table by CDC officials using rule making authority for the express purpose of denying vaccine injured children federal compensation. 100
NVIC Provides Evidence to GAO and ACCV for Betrayal of Trust
In NVIC’s statements to GAO and ACCV, we reviewed the history of the National Childhood Vaccine Injury Act of 1986 and provided evidence for why that law has become a betrayal of public trust:
FACT: By 2015, over $3 billion in federal compensation had been awarded to more than 4,000 child and adult vaccine victims but two out of three children applying for federal vaccine injury compensation have been turned down, even though there is a $3 billion dollar surplus in the Vaccine Injury Trust Fund; 101 102
FACT: Between 1988 and 1995, vaccine injured children were receiving awards through an administrative procedure. However, when CDC officials changed the rules for obtaining compensation in 1995, including rewriting the definition of encephalopathy, the system became highly adversarial. Today, almost no vaccine injured child can qualify for an uncontested award, especially if they exhibited signs of brain inflammation after vaccination and were permanently brain injured.
FACT: Today, 80 percent of vaccine injury compensation awards are given to adults disabled by flu shots and only 20 percent of awards are given to children legally required to get vaccinated to attend daycare or school;
FACT: Most vaccine injury claims take many years to adjudicate because the Departments of Health and Justice use taxpayer dollars to fight against awarding compensation for the majority of children and adults who apply;
FACT: Parents are not being informed by government officials or doctors about the very short two to three year deadlines for filing a vaccine injury compensation claim for their child, so most parents don’t even know they can file a claim and often miss the filing deadline. On NVIC.org, you can read two outside consultant reports (Banyan 103 and Altarum 104 ) that have independently confirmed that federal health officials have failed to publicize the existence of a vaccine injury compensation program;
FACT: Federal officials are not transparent with the public about details of vaccine injury awards, even though this is a requirement in the law;
FACT: Many pediatricians and other vaccine providers refuse to comply with the informing, recording and reporting vaccine safety provisions in the law. In fact, pediatrician members of the American Academy of Pediatrics and other medical trade industry groups are refusing to give children medical care if their parents do not get them vaccinated according to the CDC schedule.
The VICP Failed Experiment in Tort Reform Should Be Repealed
The vaccine injury compensation program has been a failed experiment in tort reform for many years and it is long past time for a congressional investigation. 105 Years of neglect and failure to provide oversight on a law that parents were promised would be “simple justice for children” has allowed government with the help of industry to break the program apart to the point where it cannot – and should not - be salvaged. Protecting profit-making corporations from product liability, especially when they partner with government to mandate use of their products, is a bad idea.
It is time to repeal the 1986 law and again hold pharmaceutical corporations accountable for the risks and failures of vaccine products in a civil court of law.
Without a legal check and balance on companies whose products are mandated by government, vaccines that cause harm and fail to work can stay on the market and people can be exploited, especially when government vaccine policies fail to respect biodiversity and end up selecting the genetically vulnerable for sacrifice.
Defend the Human Right to Informed Consent to Vaccine Risk Taking
The broken social contract with parents by government that at its core is a profound betrayal of public trust, is one more reason why it is so important for Americans to defend the human right to exercise voluntary informed consent to medical risk taking, especially vaccine risk taking. If we don’t protect our legal right to know and freedom to choose now, we will be held captive by corporations and government throwing the most vaccine vulnerable among us under the bus.
Explore NVIC's website and go to NVICAdvocacy.org today and find out how you can work with others in your state to secure and protect flexible medical, religious and conscientious belief exemptions in vaccine laws.
It’s your health. Your family. Your choice.
24 Coulter HL, Fisher BL. DPT: A Shot in the Dark. Harcourt Brace Jovanovich 1985.
34 The Free Dictionary. Definition of Encephalopathy: Degeneration of brain function, caused by any of various acquired disorders, including metabolic disease, organ failure, inflammation, and chronic infection. American Heritage Medical Dictionary 2007.
65 U.S. Court of Claims. Jed Snyder and Lilia Snyder, Parents of N.S., a minor, v. Secretary of Health and Human Services. Appeal from the U.S. Court of Federal Claims. See Reference # 68.
68 Snyder and Lilia Snyder, Parents of N.S., a minor, v. Secretary of Health and Human Services. VICP case alleging injury by DTaP vaccine . Compensation AWARDED Jan. 8, 2013; Compensation REVERSED (Taken Away) by US Court of Appeals for Federal Circuit on Jan. 28, 2014 after Secretary of DHHS challenged the federal compensation award for the DTaP brain injured child (this Court of Appeals decision was issued as an "unpublished or non-prejudicial" opinion).
Posted: 10/28/2015 8:29:50 AM
By Barbara Loe Fisher
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The non-profit charity, the National Vaccine Information Center (NVIC was a co-sponsor of the Truth, Transparency and Freedom rally held in Atlanta, Georgia on Oct. 24, 2015, an event coordinated by the Vaccine Injury Awareness League led by Michelle Ford.
We sent a team of NVIC staff and volunteers to Atlanta to stand in solidarity at the protest march in front of the CDC on Oct. 23 and at the rally the next day with mothers and fathers from many different states, who hold diverse cultural, political and religious beliefs but are united in a shared, unwavering commitment to save our children.
I was deeply moved by what I witnessed and experienced in Atlanta as I listened to fellow Americans from other minority communities, who, just like parents of vaccine injured children, have been marginalized and demonized by those in positions of power seeking to stigmatize, segregate and divide us. If we misunderstand and fear each other for our differences, we cannot come together as one people to defend what unites us, which is our determination to protect our health and freedom and the future of our nation.
Following is the 20-minute speech I gave at the rally in Grant Park in Atlanta on Oct. 24, 2015.
The Health Liberty Revolution to Save Our Children
by Barbara Loe Fisher
Those tiny miracles. God's most precious gift to us. We hold them in wonder just moments after they are born. We love them in a way we never loved anyone, and they love us in a way that no one else ever will.
Then, one day, we wake up. And they are as big as we are, ready to go out in the world and make their own way, and hold their own babies in their arms, completing the natural order of life.
But for many children, the natural order of life will never be completed. Some have already died. Some will one day join the ranks of the working disabled. And others will grow old and die in state homes, with the bodies of adults and the brains of babies.
For these children, the natural order of life has been forever changed by manmade viral and bacterial vaccines they were required, by law, to use.
May God bless each one of you who made the pilgrimage to Atlanta, Georgia on this day, Oct. 24, 2015, to be at this Truth, Transparency and Freedom Rally.
We have come to witness and honor our children, who have no voice and have no choice except that which we, their mothers and fathers, give to them.
We have come to defend the inalienable natural rights that unite all of us regardless of where we live, the color of our skin, the faith that sustains us, or the philosophies that define us.
We stand united in our commitment to protect this and future generations from exploitation by the pharmaceutical, chemical and medical trade industries that have polluted our earth and created the sickest and most disabled child and young adult populations in our nation's history.
We will not be silent while our children are being harmed by those who have no liability or accountability for their actions.
We will not bow down before our oppressors and witness the biological integrity of another generation of children be destroyed in this bitter harvest that can only continue if we allow it to continue.
This is a Health Liberty Revolution and we are declaring our independence from the profit-driven, fear-based toxic paradigm embraced by government and fed by industries that are bankrupting America's health care system 1 and taking away our freedom to choose how we and our children heal and stay well. 2 3
Three decades ago, on May 12, 1986, a handful of parents gathered in Atlanta to hold the first public demonstration protesting the failure of the Centers for Disease Control (CDC) to tell the people the truth about vaccine injuries and deaths. Back then, we held up signs with photos of healthy children who had been brain damaged or died from severe reactions to the crude and toxic whole cell pertussis vaccine in the DPT shot.
Today, a new generation of mothers and fathers have come to Atlanta once again to protest the failure of government to tell the truth about vaccine risks and failures. And, like 30 years ago, many of the signs you held up yesterday at the march in front of the CDC were photos of children who have died or been brain damaged after being vaccinated.
We are here to witness and talk about the suffering of our children. The suffering of vaccine injured children is no different from those who suffer from the complications of infectious disease, except that the lives of the vaccine injured are dismissed as acceptable losses, and their families are persecuted by those who do not want to see or hear about what vaccines are doing to our children. 4 5
We believe that every life is important. We will not look the other way while those vulnerable to vaccine injury and death are being sacrificed in the name of the greater good.
When the State considers one of us to be expendable, then we are all considered expendable.
It is time to hold corporations and government agencies corrupting science and exploiting the people for profit and power financially and legally accountable for what they have done, shamefully, in the name of the greater good.
The greater good of a society is never served when public health policy is based on a utilitarian pseudo ethic that uses demonization, discrimination and segregation to pit citizen against citizen and punish people for exercising their human and civil rights. 6
We will not give up our human right to exercise informed consent to medical risk taking in order to exercise our civil right to a school education, health care and employment.
It is time to stand up and throw off the chemical chains that are making us sick and reaffirm the natural rights of freedom of speech and conscience and the pursuit of life and liberty guaranteed in the U.S. Constitution.
I say this as a mother who witnessed her healthy, bright two and a half year old first born child suffer a convulsion, collapse shock and brain inflammation within hours of his fourth DPT shot in 1980 that left him with multiple learning disabilities and a 12-year sentence confined to a special education classroom in the public school system. My son did not die and he was not severely brain damaged like so many children for whom the risks of vaccination turn out to be 100 percent.
But he was part of the tidal wave of learning disabled children emerging in the 1980's, growing larger in the 1990's, and exploding in the first decade of the 21st century at precisely the same time that the government's child vaccine schedule tripled from 23 doses of 7 vaccines to a bloated 69 doses of 16 vaccines. 7 8 During those three decades, a shocking number of our children have been struck down and crippled by a chronic disease and disability epidemic sweeping through schools that now affects 1 child in 6 diagnosed with learning disabilities; 9 1 in 9 with asthma; 10 1 in 10 with ADHD; 11 1 in 12 with depression; 12 1 in 50 with autism 13 and 1 in 400 with diabetes. 14
For every parent who was able to travel to Atlanta today, there are tens of thousands who cannot come because they are at home caring for sick and disabled children. Never being well has become the new normal for children growing up in America. And the three trillion dollar a year health care price tag paid by taxpayers for that new normal today, 1516 pales in comparison to what it is going to cost tomorrow, as more and more of these chronically ill and disabled children become adults.17 18 19 20
Where are they going to live? What kind of jobs will they hold? What happens when their parents die?
Public health officials and pediatricians cannot tell us why so many of our children are crowding special education classrooms, doctors offices and mental health facilities, and they are doing absolutely nothing to find out. They just repeat over and over again that this failing public health report card has absolutely nothing to do with atypically manipulating the immune systems of pregnant women with four vaccines given in any trimester 21 and doing the same thing to children over and over again in the first six years of life, starting on the day of birth, with 49 vaccinations 22 that contain genetically engineered viruses and bacteria and a cocktail of ingredients like mercury, aluminum, formaldehyde, phenoxyethanol, gluteraldehyde, proteins, synthetic particles, antibiotics, and human, animal and insect DNA and RNA, plus allowable amounts of adventitious agents.23
Government health officials claim – but have failed to scientifically prove - that our children's health is not affected by repeatedly hyperstimulating inflammatory responses with vaccines; or feeding them GMO and processed foods laced with pesticides, hormones and antibiotics; 24 or giving them water contaminated with fluoride; 25 or allowing dentists to put mercury fillings in their mouths; 26 or giving them amphetamines, anti-depressants and other kinds of prescription drugs 27 with side effects that include suicidal thoughts and violent behavior.
CDC officials and pediatricians cannot explain why, today, everybody either has a child or knows a child who was born healthy, then suddenly regressed physically, mentally and emotionally and joined the ranks of the walking wounded. They cannot tell us why so many children were once healthy, got vaccinated and were never healthy again. They refuse to do the good science to find out why the bodies of so many highly vaccinated children are on fire, riddled with chronic inflammation that is at the root of most brain and immune system disorders, including ADHD, epilepsy, allergies, asthma, autism, diabetes, inflammatory bowel disease, obesity, cancer, schizophrenia and depression. 28
It was not always this way in America. I grew up in the 1950's and 60's and remember when every child got measles, mumps and chickenpox before age 10, but there were no special education classrooms in public schools to house legions of learning disabled, autistic and emotionally disturbed children. I remember when it was the rare child who had asthma or diabetes and there was no need to store student supplies of Ritalin and Prozac in the school nurse's office. I remember when we all brought peanut butter sandwiches in our lunch bags to school without being afraid it would kill one of our classmates. 29
The biggest public health emergency in America is not a few measles cases at Disneyland in a population of 320 million people, 30 where less than one percent of all children are unvaccinated and 95 percent of them have gotten two measles shots and five pertussis shots, plus dozens of doses of other vaccines. 31 32
The real public health emergency in America is the one that is being covered up by government and industry working overtime with the mainstream media to distract, deceive, stonewall and restrict the freedom of Americans to take control of their health. Instead of doing everything they can to find out why so many children are so sick and disabled, industry and government are working together to eliminate our legal to make voluntary vaccine choices and eat organic 33 and choose chiropractic, acupuncture, homeopathy, naturopathy, herbs, vitamins, natural supplements and other non-pharmaceutical options for healing and staying well.
Over the past quarter century, Congress has given permission for government to forge a public-private business partnership with the pharmaceutical and chemical industries. The U.S. and global vaccine market alone is a $30 billion dollar business but in 10 years, Big Pharma will enjoy a $100 billion dollar vaccine business. 34 The most influential and wealthy lobby on Capitol Hill has spent billions of dollars to co-opt federal research, regulatory and policymaking agencies and academic institutions in this country. 35 This influence peddling guarantees that junk science favoring industry profit-making is the only kind of science that informs public health policy.
So when Congress appropriates $1 trillion dollars a year to the Department of Health, government officials employed by the CDC, NIH and FDA do not use that taxpayer money to conduct basic science research to identify children at high risk for vaccine injury, 36 or to compare the health of vaccinated and unvaccinated children to find out why parents consistently report that unvaccinated children are healthier and get higher grades in school than vaccinated children. 37 They do not use that money to find out why infectious microbes are evolving into more virulent and vaccine resistant forms after 50 years of mass vaccination policies 38 or to determine whether more children are developing genetic mutations after vaccination that damages their DNA. 39
Instead, public health officials hide their heads in the sand and collaborate with industry to create hundreds of new experimental vaccines that will be fast tracked to licensure and forced on you and everyone you know – no exceptions and no questions asked. 40 41 42 They are using electronic medical records tracking systems to monitor your vaccination status and lobby for vaccination laws that require you to adhere to a cradle to the grave vaccine schedule that will include an AIDS vaccine and every other vaccine that Big Pharma markets and the CDC recommends in the future. 43
Today, if you are a child or adult and live in California or other states that have already eliminated religious and conscientious belief vaccine exemptions and you refuse one or more government mandated vaccines, you cannot get a school education, medical care or be employed as a child or health care worker unless you can find a doctor to write a medical vaccine exemption that 99.99 percent of Americans do not qualify for under federal guidelines.44
And tomorrow? Well, if Americans do not get up off their knees and stop worshipping doctors promoting junk science, it is not possible but probable, that tomorrow you will not be able to get on a bus, train or plane; enter a store or sports arena; obtain a driver's license, file your taxes or function in society unless you can prove you have gotten every vaccine that industry creates and doctors implementing government policy order you to get.
And when you or your child suffer brain inflammation and collapse, have convulsions and never recover your health after getting vaccinated, you can be sure that industry and government will either dismiss it as “just a coincidence,” or label you genetically defective and claim you would have become brain damaged even if no vaccines had been given. It is already being done and it is so easy to do that, when nobody making, selling, licensing, giving and voting to mandate liability free vaccines has any accountability, and CDC officials can throw scientific evidence about vaccine risks into garbage cans.45
And the ones who know deep in the core of their being that they are not being told the truth about vaccine risks, and sense that their children are in danger, are mothers, who carry their babies inside them for nine months and give birth and are endowed with a primal instinct that God gave women so they have the courage to protect their babies from harm until they are able to survive on their own. That biological imperative to outlive our children is hard wired into our DNA because it is what protects the survival of every species on this earth.
As mothers, we are responsible for our children's health. We are the ones who care for them when they become sick and unable to care for themselves for any reason, and we are the ones who stand with their fathers and weep at their graves if they die before we do. And yet, thinking Moms who use their intellect to evaluate the benefits and risks of vaccination for their child and then listen to their gut instincts and act rationally to protect their children from harm, are being bullied, ridiculed and punished by pediatricians for making vaccine and other health care choices for their children that do not conform with government policy46
The freedom to follow our conscience when deciding what we will risk our life or the life of our child for is a human right.47 48 It is at the heart of what it means to be free.
Because if the State can tag, track down and force individuals to be injected with biologicals of known and unknown toxicity today, then there will be no limit on which individual freedoms the state can take away in the name of the greater good tomorrow.
Liability free doctors inside and outside of government should never be given the power to force us to play vaccine roulette with liability free vaccines.
And corporations marketing pharmaceutical products that can injure and kill us and our children should never be given a shield from legal accountability for the safety of their products in a civil court of law in front of a jury of our peers.
In 1986, Congress passed the National Childhood Vaccine Injury Act after drug companies threatened to leave America without a childhood vaccine supply if they were not protected from vaccine injury lawsuits. 49 The 1986 law confirmed that vaccines can injure and kill and gave partial liability protection to vaccine manufacturers and pediatricians by creating a federal vaccine injury compensation system alternative to a vaccine injury lawsuit. 50
Congress promised parents that the compensation program would be a no-fault, non-adversarial, expedited, less expensive and less traumatic administrative alternative to suing pharmaceutical corporations and negligent doctors. Parents were also promised that the historic vaccine informing, recording, reporting and research safety provisions secured by co-founders of the National Vaccine Information Center into that law, would be enforced.
In 2011, when the U.S. Supreme Court declared that vaccines are “unavoidably unsafe” and effectively handed the pharmaceutical industry a total product liability shield from vaccine injury lawsuits - even when there is evidence that a drug company could have made a vaccine safer – the compensation program became the exclusive legal remedy for vaccine injured Americans.51 And with that free pass, government and industry immediately moved into state legislatures to eliminate personal belief vaccine exemptions as well as federal compensation for vaccine injured children.
Every single promise that Congress made to parents in 1986 was a lie. In what has become a profound betrayal of public trust, the social contract government made with parents obeying vaccine laws in America has been irreparably broken.
Although three billion dollars has been awarded to about 4,000 vaccine victims, 52 there is $3 billion dollars still sitting in the Trust Fund because government fights almost every single claim, and two out of three vaccine injured persons are turned away empty handed. The majority of awards are paid to adults injured by flu vaccine and not to children who suffer brain inflammation and are disabled for the rest of their lives after receiving one or more of the 16 government recommended and state mandated vaccines. The Secretary of Health and Justice Department lawyers drag out the compensation claims process for years 53 and have gutted the rules for compensation so that few children qualify, turning the program into a cruel imitation of a court trial with no jury. Doctors giving vaccines refuse to obey the vaccine safety provisions because there is no enforcement.
Congress has failed to provide oversight on the 1986 law, allowing government agencies to deliberately destroy the National Childhood Vaccine Injury Act and turn it into a drug company stockholder's dream and a parent's worst nightmare.
The 1986 law is a failed experiment in tort reform 54 and it should be repealed.
The pharmaceutical industry and negligent doctors must be held fully accountable and liable for vaccine injuries and deaths in civil court. And every public health law in America must include informed consent protections in the form of flexible medical, religious and conscientious belief exemptions.
Truth, transparency, accountability and freedom protect against tyranny and there is no greater calling for Americans in the 21st century than to take action to restore those cultural values in government and our nation's institutions.
The Millennials, whose children could be subjected to twice as many vaccinations as children are given today, are joining hands with Generation X and picking up the torch that was lit by parents of DPT vaccine injured children in 1982, when we launched the organized vaccine safety and informed consent movement in America. Your journey has begun here in Atlanta, just like ours began in Atlanta 30 years ago.
The mountain you must climb is high, but you will climb it and bring about a new age of enlightenment in this Health Liberty Revolution led by people for the people. And you will not give up, just like we have not given up, because we are doing this work to save our children and the country we love.
We are the daughters and sons of liberty, and our mission continues:
No forced vaccination. Not in America.
Posted: 9/20/2015 9:51:57 AM
by Barbara Loe Fisher
1986 march in Atlanta (CDC)
In the spring of 1986, NVIC co-founder Kathi Williams and I gathered with a small group of parents in Atlanta, Georgia to hold the first public demonstration demanding that the Centers for Disease Control (CDC) be truthful with the American public about vaccine injuries and deaths. We held up signs with photos of children who had died or been brain injured by toxic whole cell DPT vaccine to witness and honor them, the children who had no voice and had no choice.
Pharma-Led Forced Vaccination Lobby Attacks Human & Civil Rights
Almost 30 years later, on Saturday, October 24, 2015 from 12 - 4:00 p.m. (please note updated time), Kathi and I will again gather with parents in Atlanta, this time for the Truth, Transparency & Freedom Rally in Grant Park. The rally is being organized and sponsored by the parent-led Vaccine Injury Awareness League (VIAL), a small California non-profit founded this year after the Pharma-led forced vaccination lobby descended upon that state’s legislature and attacked the human right to informed consent to medical risk taking so they could eliminate the personal belief vaccine exemption and the civil right to a school education.
NVIC Stands in Solidarity with Parents
Dave McCutcheon and parents marching in Atlanta 1986
The National Vaccine Information Center stands in solidarity with parents who are gathering in Atlanta and witnessing about what happened to their once healthy children, and are again calling on the CDC to tell the public the truth about vaccine injuries and deaths.
We stand with in solidarity with all who want to protect the right to know and the freedom to choose how to stay healthy in America.
We stand in solidarity with all who reject the politics of demonization, discrimination and segregation that pit parent against parent, citizen against citizen, and violate basic human and civil rights.
We will not allow another generation of children to lose their health because government continues to protect the liability free vaccine industry and covers up vaccine risks and failures, while our children are crippled in the chronic disease and disability epidemic sweeping through America’s schools.
YES to Democracy, NO to Corporatocracy
Many people coming to the rally in Atlanta are united in defending freedom of speech and conscience. They believe it is time to speak out about the business partnership between industry and government that is turning our democracy into a corporatocracy and threatening the health of our nation.
Defend Inalienable Natural Rights and Health Liberty!
On Saturday, October 24, be in Atlanta and defend the inalienable natural rights embodied in the U.S. Constitution, which unite all of us regardless of where we live, the color of our skin, the faith that sustains us or the philosophies that define us. Bring your friends, your spirit, your love and your commitment and stand in solidarity with others who are there for the same reason.
Go to CDCtruth.org to learn more.
It’s your health. Your family. Your choice.
Download poster about rally here.
Posted: 9/16/2015 9:33:17 AM
During the Sept. 15, 2015 meeting of the FDA's advisory committee on vaccines, Vaccines and Related Biological Products Advisory Committee (VRBPAC), the committee voted to fast-track licensure of the MF59 adjuvanted Fluad influenza vaccine. NVIC's President and Co-Founder, Barbara Loe Fisher gave the following public comment in opposition to licensure of the Fluad vaccine. NVIC has also issued a press release on the VRBPAC decision that may be read here
Barbara Loe Fisher, Co-founder and President
National Vaccine Information Center
Opposition to Fast Track Licensure of MF59 Adjuvanted Fluad
FDA Vaccines and Related Biological Products Advisory Committee (VRBPAC)
Sept. 15, 2015
Squalene adjuvants hyper-stimulate the immune system and have been linked with development of autoimmunity, narcolepsy and other chronic disease.1 2 3 Based on the very limited safety and immunogenicity evidence submitted by Novartis,4 MF59 adjuvanted Fluad vaccine should not be fast tracked to licensure for use by seniors over age 65 in the U.S. for the following reasons:
- FDA states there is uncertainty about how MF59 affects immune function but it is “thought” to activate local cells and has been “shown to directly increase phagocytosis” in human immune cells and to induce cytokines.5If MF59 does that, it is an active ingredient and should be proven safe in a placebo controlled trial.
- Influenza vaccines induce immune mediated responses, whether adjuvanted or unadjuvanted. Comparing adverse responses following receipt of one adjuvanted bioactive product to those of an unadjuvanted bioactive product does not prove safety unless both are compared to an inactive placebo.6 7 Novartis did not compare Fluad to an inactive placebo.
- It is well known that responses to vaccination are affected by genetic factors. The Pivotal Study population clearly was not genetically representative of U.S. seniors over age 65, a population that is over 80 percent Caucasian, 9 percent Black, 7 percent Hispanic and 4 percent Asian.8 Fluad was only given to about 1,000 U.S. seniors, while more than 2,400 Fluad recipients were from countries with high majority Asian or Hispanic populations.9
- The trial exclusion criteria is so broad that the health of most of the study participants does not match that of the majority of U.S. seniors over age 65, of whom two-thirds have two or more chronic conditions such as heart, lung and kidney disease,10 11 and will be candidates for receipt of Fluad post-licensure.
- Compared to Agriflu, Fluad produced a much higher number of pain, tenderness, redness and swelling reports; a higher number of systemic adverse event reports and more deaths and cases of new onset chronic disease.12
- The Pivotal Study provides no information about the safety of giving seniors with multiple chronic conditions repeated doses of squalene adjuvanted Fluad every year and no information about how Fluad performs when given simultaneously with other vaccines.
- Using surrogate markers in the Pivotal Study, Novartis was not able to demonstrate that Fluad was superior to Agriflu with regard to immunogenicity, while Novartis was able to demonstrate that squalene adjuvanted Fluad is more reactive.13
Why does Fluad need to be fast tracked to licensure for seniors without additional evidence? There is public concern that fast tracking Fluad is really about fast tracking MF59 to licensure so it can be added to lots of new vaccines targeting infants, pregnant women and every American without adequate evidence for safety or effectiveness.