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Thread: 55 Groups Representing 5 Million Serve Legal Notice to HHS for Failure on Vaccine Safety

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    Default 55 Groups Representing 5 Million Serve Legal Notice to HHS for Failure on Vaccine Safety

    55 Organizations Representing 5 Million Serve Legal Notice to HHS for Failure to Conduct Vaccine Safety Tests: Civil Action to Follow?

    Each time a parent decides to have their child vaccinated, they do so believing that each vaccine has been rigorously tested for vaccine safety and efficacy. Equally, they are of the understanding that their child will be protected from deadly diseases once they have received the vaccine.

    In reality, however, vaccines are not being tested for safety before entering the market. This is because the creation of the 1986 National Vaccine Injury Compensation Program took all liability away from the pharmaceutical industry and transferred it to the health department. Due to these actions, it is now the responsibility of the U.S. Department of Health and Human Services to conduct all the safety testing that the pharmaceutical industry no longer has to do.

    Mr. Del Bigtree, producer of the film VAXXED which chronicles the revelations of a CDC whistleblower who revealed that data showing a vaccine-autism connection was covered up, stated on camera that:

    “We believe that there is a major failure of Health and Human Services (HHS) to do the appropriate safety tests.”


    Angered by what he believes to be the lack of science and appropriate testing being carried out by the HHS, Mr. Bigtree and the Informed Consent Action Network (ICAN), supported by 55 organizations representing over 5 million people, have taken the unprecedented step of serving a notice to Mr. Don Wright, M.D., M.P.H., who is the acting secretary of the HHS department, demanding action to be taken.

    This notice, served on October 12, 2017, outlined exactly how the HHS department had failed in their duty to conduct the proper scientific research required to demonstrate vaccine safety.

    It stated that:

    “All drugs licensed by the FDA undergo long-term double-blind pre-licensure clinical trials during which the rate of adverse reactions in the group receiving the drug under review is compared to the rate of adverse reactions in a group receiving an inert placebo, such as a sugar pill or saline injection.

    For example: Enbrel’s pre-licensure trials followed subjects up to 80 months and controls received a saline injection.3 Lipitor’s pre-licensure trials lasted a median of 4.8 years and controls received a sugar pill.4 Botox’s pre-licensure trials lasted a median of 51 weeks and controls received a saline injection.5 And even with these long-term studies, drugs are still often recalled.”
    The authors continued:

    “In contrast, vaccines are not required to undergo long-term double-blind inert-placebo controlled trials to assess safety.

    In fact, not a single one of the clinical trials for vaccines given to babies and toddlers had a control group receiving an inert placebo.

    Further, most pediatric vaccines currently on the market have been approved based on studies with inadequate follow up periods of only a few days or weeks.”
    They identified several vaccinations that had been inadequately tested and in particular highlighted the hepatitis B vaccination which had been licensed by the FDA for injection into newborn babies. They stated:

    “Hepatitis B vaccines licensed by the FDA for injection into one day old babies, Merck’s was licensed after trials that solicited adverse reactions for only five days after vaccination and GlaxoSmithKline’s was licensed after trials that solicited adverse reactions for only four days after vaccination.”
    To inject a newborn baby with a vaccine that had only been, at best, checked for adverse reactions after five days, is not only dangerous, but it is also wholly irresponsible and this travesty was made clear in their letter.

    Questions were asked of the secretary to explain the following points:

    • Please explain how HHS justifies licensing any pediatric vaccine without first conducting a long-term clinical trial in which the rate of adverse reactions is compared between the subject group and a control group receiving an inert placebo?
    • Please list and provide the safety data relied upon when recommending babies receive the Hepatitis B vaccine on the first day of life?


    These are important questions which need to be answered, especially when you consider that the U.S. vaccination schedule currently recommends that children receive a total of 56 injections of 73 doses of 30 different vaccines beginning on day one of their life.

    Only a Fraction of Vaccine Injuries and Deaths Have Ever Been Reported

    Bigtree and his colleagues pointed out that only a fraction of the true number of adverse events are reported to Vaccine Adverse Event Reporting System (VAERS) database.

    He referred to the HHS-funded study conducted by Harvard Medical School, which had tracked reporting to VAERS over a three-year period at Harvard Pilgrim Health Care, and he highlighted how they had discovered that less than 1% of vaccine adverse events are reported.

    They stated that:

    “A U.S. House Report similarly stated: ‘Former FDA Commissioner David A. Kessler has estimated that VAERS reports currently represent only a fraction of the serious adverse events.'”
    Worrisomely, they continued by highlighting the fact that:

    “While HHS strongly supports automating public health surveillance systems, when it comes to vaccine safety, the CDC has only supported projects that would limit VAERS to passive surveillance.

    Automation would improve safety and address many of the long-standing issues and limitations raised by CDC regarding VAERS.

    Capturing ‘fewer than 1% of vaccine adverse events’ thirty years after the passage of the 1986 Act is unacceptable — and potentially deadly.”
    They questioned why HHS had failed in their duty to cooperate with Harvard and automate the VAERS database and asked what steps had been made by the HHS to improve the reporting of adverse reactions to VAERS.

    Bigtree and his colleagues highlighted in full the many adverse reactions known to be caused by vaccines. They stated that:

    “In 2011, more than fifteen years after the Institute of Medicine (IOM) Reports in 1991 and 1994, HHS paid the IOM to conduct another assessment regarding vaccine safety.

    This third IOM Report reviewed the available science with regard to the 158 most common vaccine injuries claimed to have occurred from vaccination for varicella, hepatitis B, tetanus, measles, mumps, and rubella.

    The IOM located science which “convincingly supports a causal relationship” with 14 of these injuries, including pneumonia, meningitis, hepatitis, MIBE, febrile seizures, and anaphylaxis.

    The review found sufficient evidence to support “acceptance of a causal relationship” with 4 additional serious injuries.”
    Continuing that:

    “The IOM, however, found the scientific literature was insufficient to conclude whether or not those vaccines caused 135 other serious injuries commonly reported after their administration, including:

    Encephalitis, Encephalopathy, Infantile Spasms, Afebrile Seizures, Seizures, Cerebellar Ataxia, Acute Disseminated Encephalomyelitis, Transverse Myelitis, Optic Neuritis, Neuromyelitis Optica, MultipleSclerosis, Guillain-Barre Syndrome, Chronic Inflammatory Demyelinating Polyneuropathy, Brachial Neuritis, Amyotrophic Lateral Sclerosis, Small Fiber Neuropathy, Chronic Urticaria, Erythema Nodosum, Systemic Lupus Erythematosus, Polyarteritis Nodosa, Psoriatic Arthritis, Reactive Arthritis, Rheumatoid Arthritis, Juvenile Idiopathic Arthritis, Arthralgia, Autoimmune Hepatitis, Stroke, Chronic Headache, Fibromyalgia, Sudden Infant Death Syndrome, Hearing Loss, Thrombocytopenia, and Immune Thrombocytopenic Purpura.

    Thus, out of the 158 most common serious injuries reported to have been caused by the vaccines under review, the evidence supported a causal relationship for 18 of them, rejected a causal relationship for 5 of them, but for the remaining 135 vaccine-injury pairs, over 86 percent of those reviewed, the IOM found that the science simply had not been performed.”
    These are all extremely serious failures in the duty of care and have affected the lives of hundreds of thousands of children, and yet nothing is being done to protect the health and safety of our children.

    Bigtree and his team made it clear that immediate action was required, demanding an explanation why the HHS had not identified, as instructed, which children were most at risk of suffering a vaccine injury.

    They highlighted the known fact that some children are more susceptible to vaccine injury than others and highlighted the fact that the IOM had previously acknowledged the need to research on such susceptibility, on an individual basis, considering a child’s personal genome, behaviors, microbiome, intercurrent illness, and present and past environmental exposure.

    Questions were raised as to why, after all these years, this research had still not been carried out.

    HHS Failed in Their Duty to Take Vaccine Safety Seriously

    Bigtree and his team pointed out that the HHS has continued to treat the subject of vaccination safety as little more than a public relations issue and demanded to know why. They stated that:

    “HHS, unfortunately, has treated vaccine safety as a public relations issue rather than a public health imperative. For example, the CDC claims on its website that ‘Vaccines Do Not Cause Autism’ even though this broad claim is plainly not supported by the scientific literature.”
    They continued:

    “Instead, HHS’ claim that ‘Vaccines Do Not Cause Autism’ relies almost entirely upon studies exclusively studying only one vaccine, MMR (which is administered no earlier than one year of age), or only one vaccine ingredient, thimerosal, with regard to autism.

    Putting aside the controversy surrounding these studies, studies which focus on only one vaccine and one ingredient while ignoring the entire balance of the CDC’s pediatric vaccine schedule cannot support the CDC’s overarching declaration that ‘Vaccines Do Not Cause Autism.’

    As for the MMR vaccine, the CDC’s own Senior Scientist, Dr. William Thompson, recently provided a statement through his attorney that the CDC ‘omitted statistically significant information’ showing an association between the MMR vaccine and autism in the first and only MMR-autism study ever conducted by the CDC with American children.

    Dr. Thompson, in a recorded phone call, stated the following regarding concealing this association: ‘Oh my God, I can’t believe we did what we did. But we did. It’s all there. It’s all there. I have handwritten notes.'”


    Will There be Civil Action Taken Against HHS for Their Failure to Ensure Vaccine Safety?

    In its entirety, their notice consisted of 19 pages. They concluded that:

    “HHS can do better. With hundreds of vaccines in the pipeline it must do better.

    Children susceptible to vaccine injury are as deserving of protection as any other child. Avoiding injury to these children is not only a moral and ethical duty, but will in fact strengthen the vaccine program.

    Every parent that does not witness their child suffer a serious reaction after vaccination, such as a seizure or paralysis, is another parent that will not add their voice to the growing chorus of parents opposed to HHS’s vaccine program due to safety concerns.

    Unless HHS performs its vital statutory obligations regarding vaccine safety, and until a frank conversation is possible regarding vaccine safety, children susceptible to vaccine injury will not be protected from such injuries. Nor will children injured by vaccines be able to access the services they need. We can do far better in protecting and serving children who are susceptible or succumb to serious injuries from vaccination. The first step in avoiding these harms and helping children already harmed is admitting there are deficiencies and working diligently to improve vaccine safety.”
    In serving this notice together, Mr. Bigtree and ICAN have recognized and made a stand, the HHS needs to be held accountable for their actions. If they do not address these concerns, Congress has given authority for Civil Action to be taken:

    We respectfully request your attention to the important concerns outlined above and hope you agree that addressing these concerns is in everyone’s best interest.

    These, in fact, reflect nothing more than what Congress already explicitly recognized when passing the 1986 Act: vaccines can and do cause serious injury and HHS needs to work diligently to identify and reduce these harms.

    If you would like to meet and discuss the foregoing, we would welcome that opportunity and hope to work cooperatively to address these issues.

    If that is not possible, Congress, as a final resort to assure vaccine safety, authorized a “civil action … against the Secretary where there is alleged a failure of the Secretary to perform any act or duty under” the 1986 Act. (42 U.S.C. § 300aa-31(a).)

    We are prepared to authorize such an action and this letter constitutes the notice required by 42 U.S.C. § 300aa-31(b).

    It is, however, our hope that the vaccine safety issues identified herein can be resolved cooperatively, with all interested parties working together toward the common goal of vaccine safety entrusted to HHS under the 1986 Act.
    Read the full notice here.

    Parents trust such organizations to get vaccine safety right. If these organizations fail in their duty to protect children from harm, then that trust is broken, and if parents do not trust that the routine vaccinations have been adequately tested, then they have a right to refuse to have their children vaccinated.
    Uncensored Health Freedom News:
    http://healthimpactnews.com/

    Yes, I believe the science of vaccines is settled - Zippyjuan Team



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