It’s official! The US Department of Health and Human Services (HHS) and, by extension, the US Centers for Disease Control and Prevention (CDC) have been put on legal notice. The notice requests confirmation that certain obligations regarding vaccine safety have been or will be fulfilled.
Why the HHS? Due the National Childhood Vaccine Injury Act of 1986 (the 1986 Act), the HHS shoulders virtually all responsibility for assuring the safety of vaccines being administered to America’s 78 million children. The 1986 Act allows Congress to step in if any act or duty ensuring vaccine safety is abandoned or failed. As it stands, such a burden falls upon the shoulders of the Acting Secretary of the HHS, Eric D. Hargan, and his agency.
After decades of its government passing the buck, avoiding reality, and ignoring the science, America has had enough. An awakening is hitting breakaway speeds as communities are rejecting coercive vaccination practices. Parents have leveraged and dominated social media platforms to sound the alarm about long-failed policies. Meanwhile, a submissive American medical community has forgotten its ethic of informed consent and lost sight of its original oath to do no harm.
The notice was served recently by a non-profit organization Informed Consent Action Network (ICAN) founded by Del Bigtree. What is ICAN asking? There are 11 specific questions and points in the notice that previous HHS and CDC leadership should have addressed. But here we are, in 2017, having to serve our government oversight body a legal notice to ensure they do their stated duties.
ICAN’s questions and points are as follows:
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?
Please explain why HHS failed to cooperate with Harvard to automate VAERS reporting? And detail any steps that HHS has taken since toward automating VAERS reporting?
Please explain any specific steps taken by HHS to improve adverse reaction reporting to VAERS?
For each of the 38 vaccine-injury pairs reviewed in the 1994 IOM Report which the IOM found lacked studies to determine causation, please identify the studies undertaken by the HHS to determine whether each injury is caused by vaccination?
For each of the 135 vaccine-injury pairs reviewed in the 2011 IOM Report which the IOM found lacked studies to determine causation, please identify the studies undertaken by the HHS to determine whether each injury is caused by vaccination?
Please explain what HHS has done to assure that health care providers record the manufacturer and lot number for each vaccine they administer?
Please advise when HHS intends to begin conducting research to identify which children are susceptible to serious vaccine injury? If HHS believes it has commenced this research, please detail its activities regarding same?
Please confirm that HHS shall forthwith remove the claim that “Vaccines Do Not Cause Autism” from the CDC website, or alternatively, please identify the specific studies on which HHS bases its blanket claim that no vaccines cause autism?
Please advise whether HHS intends to forthwith conduct adequately powered and controlled prospective as well as retrospective studies comparing total health outcomes of fully/partially vaccinated children with completely unvaccinated children?
Regarding conflicts of interest and possible steps to reduce them, ICAN's legal notice asks if HHS will:
A. prohibit conflict waivers for members of HHS’s vaccine committees (ACIP, VRBPAC, NVAC & ACCV)?
B. prohibit HHS vaccine committee members or HHS employees with duties involving vaccines from accepting any compensation from a vaccine maker for five years?
C. require that vaccine safety advocates comprise half of HHS’s vaccine committees?
D. allocate toward vaccine safety an amount at least equal to 50% of HHS’s budget for promoting/purchasing vaccines?
E. support the creation of a vaccine safety department independent of HHS?
F. support the repeal of the 1986 Act to the extent it grants immunity to pharmaceutical companies for injuries caused by their vaccine products?
The US regulatory failure and avoidance of responsibility from official organs of the government has reached a crescendo of legendary proportions. People at all levels of American society have provided sustained and ample opportunity for the right moves to take place by the HHS to correct massive failures inherent within the vaccine industry and its regulatory oversight. The People have been patient even as their loved ones around them have generationally shouldered the burdens of physical injury from vaccine products with known, long-standing risks. America has collectively stood by and waited with stoic patience for politicians to act as both its brain trust and wealth has been extracted for little more than pharmaceutical industry profit. In the absence of self-correcting regulatory agencies and in the face of inept political action, the American people have activated through a true grassroots movement birthed from loss and suffering at the hands of vaccine injury.
For anyone who has been paying attention to the actions of multiple US government agencies in regards to vaccine safety, their previous behaviors that have led us all to this point have mirrored those of a hopeless addict. Our country’s history of the past decades are marred by government’s continuous unwillingness to see the harm caused by their own actions while doubling-down at every opportunity to reverse the addiction when clear issues have presented themselves. It is both ICAN and the American people's hope that HHS will give full, detailed responses to its failures and plans for their immediate remedies. At the very least, it is now imperative that HHS admit the numerous shortcomings of vaccine safety oversight in hopes of starting down the path towards correcting errors that have compounded over the decades into a monumental catastrophe resulting in real human injury.
Making it clear that this is not a public relations stunt or simply lip service, the ICAN notice explicitly states in the closing paragraph:
“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).”
Why the HHS? Due the National Childhood Vaccine Injury Act of 1986 (the 1986 Act), the HHS shoulders virtually all responsibility for assuring the safety of vaccines being administered to America’s 78 million children. The 1986 Act allows Congress to step in if any act or duty ensuring vaccine safety is abandoned or failed. As it stands, such a burden falls upon the shoulders of the Acting Secretary of the HHS, Eric D. Hargan, and his agency.
After decades of its government passing the buck, avoiding reality, and ignoring the science, America has had enough. An awakening is hitting breakaway speeds as communities are rejecting coercive vaccination practices. Parents have leveraged and dominated social media platforms to sound the alarm about long-failed policies. Meanwhile, a submissive American medical community has forgotten its ethic of informed consent and lost sight of its original oath to do no harm.
The notice was served recently by a non-profit organization Informed Consent Action Network (ICAN) founded by Del Bigtree. What is ICAN asking? There are 11 specific questions and points in the notice that previous HHS and CDC leadership should have addressed. But here we are, in 2017, having to serve our government oversight body a legal notice to ensure they do their stated duties.
ICAN’s questions and points are as follows:
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?
Please explain why HHS failed to cooperate with Harvard to automate VAERS reporting? And detail any steps that HHS has taken since toward automating VAERS reporting?
Please explain any specific steps taken by HHS to improve adverse reaction reporting to VAERS?
For each of the 38 vaccine-injury pairs reviewed in the 1994 IOM Report which the IOM found lacked studies to determine causation, please identify the studies undertaken by the HHS to determine whether each injury is caused by vaccination?
For each of the 135 vaccine-injury pairs reviewed in the 2011 IOM Report which the IOM found lacked studies to determine causation, please identify the studies undertaken by the HHS to determine whether each injury is caused by vaccination?
Please explain what HHS has done to assure that health care providers record the manufacturer and lot number for each vaccine they administer?
Please advise when HHS intends to begin conducting research to identify which children are susceptible to serious vaccine injury? If HHS believes it has commenced this research, please detail its activities regarding same?
Please confirm that HHS shall forthwith remove the claim that “Vaccines Do Not Cause Autism” from the CDC website, or alternatively, please identify the specific studies on which HHS bases its blanket claim that no vaccines cause autism?
Please advise whether HHS intends to forthwith conduct adequately powered and controlled prospective as well as retrospective studies comparing total health outcomes of fully/partially vaccinated children with completely unvaccinated children?
Regarding conflicts of interest and possible steps to reduce them, ICAN's legal notice asks if HHS will:
A. prohibit conflict waivers for members of HHS’s vaccine committees (ACIP, VRBPAC, NVAC & ACCV)?
B. prohibit HHS vaccine committee members or HHS employees with duties involving vaccines from accepting any compensation from a vaccine maker for five years?
C. require that vaccine safety advocates comprise half of HHS’s vaccine committees?
D. allocate toward vaccine safety an amount at least equal to 50% of HHS’s budget for promoting/purchasing vaccines?
E. support the creation of a vaccine safety department independent of HHS?
F. support the repeal of the 1986 Act to the extent it grants immunity to pharmaceutical companies for injuries caused by their vaccine products?
The US regulatory failure and avoidance of responsibility from official organs of the government has reached a crescendo of legendary proportions. People at all levels of American society have provided sustained and ample opportunity for the right moves to take place by the HHS to correct massive failures inherent within the vaccine industry and its regulatory oversight. The People have been patient even as their loved ones around them have generationally shouldered the burdens of physical injury from vaccine products with known, long-standing risks. America has collectively stood by and waited with stoic patience for politicians to act as both its brain trust and wealth has been extracted for little more than pharmaceutical industry profit. In the absence of self-correcting regulatory agencies and in the face of inept political action, the American people have activated through a true grassroots movement birthed from loss and suffering at the hands of vaccine injury.
For anyone who has been paying attention to the actions of multiple US government agencies in regards to vaccine safety, their previous behaviors that have led us all to this point have mirrored those of a hopeless addict. Our country’s history of the past decades are marred by government’s continuous unwillingness to see the harm caused by their own actions while doubling-down at every opportunity to reverse the addiction when clear issues have presented themselves. It is both ICAN and the American people's hope that HHS will give full, detailed responses to its failures and plans for their immediate remedies. At the very least, it is now imperative that HHS admit the numerous shortcomings of vaccine safety oversight in hopes of starting down the path towards correcting errors that have compounded over the decades into a monumental catastrophe resulting in real human injury.
Making it clear that this is not a public relations stunt or simply lip service, the ICAN notice explicitly states in the closing paragraph:
“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).”