Please restore Public Health Law 2164 to its original form and discard the Emergency Regulations that temporarily amended this law. There is no emergency in NY that would necessitate these restrictions, which have thus far, severely harmed children and families across the state and dramatically impacted a physician’s ability to practice medicine in accordance with their training, expertise and ethical obligations. I implore you to safeguard New York’s most vulnerable children by allowing their doctor to make medical decisions on their behalf. As a concerned member of the public, I urge you to consider the following points when making your determination:
1. ACIP guidance alone is insufficient for determining medical exemptions, and it should not be allowed to overrule a child’s treating physician.
As clearly stated by Andrew Kroger MD, MPH, Communications and Education Branch of the Immunization Service Division of the CDC: “It would be inappropriate for anyone other than the treating provider to determine who should be allowed to get a medically-necessary exemption. The ACIP guidelines were never meant to be a population-based concept…The CDC does not determine medical exemptions. We define contraindications. It is the medical provider’s prerogative to determine whether this list of conditions can be broader to define medical exemptions.”
ACIP guidance is a model for practitioners to use while assessing vaccine benefits and risks. In addition to that guidance, each vaccine insert includes sections on precautions, contraindications and warnings for that specific vaccination, many of which are not captured by the ACIP guidance. The Institute of Medicine has also identified numerous vaccine dangers, indications, cautions, precautions and adverse events that are not being reported by ACIP or the CDC.
2. The National Childhood Vaccine Injury Act of 1986, Congress directed DHHS to contract with the Institute of Medicine (IOM), to evaluate and report on adverse effects of federally recommended childhood vaccines.
Beginning in 1990, IOM appointed committees of experts to review the evidence in the medical literature on the safety of government mandated childhood vaccines. The IOM has identified numerous vaccine dangers, indications, cautions, precautions and adverse events that are not being reported by ACIP or CDC, although required under the Vaccine Act.
IOM published a series of reports on evidence for adverse effects of vaccines between 1991 and 2013 confirming that:
● Vaccines can and do carry risks for complications that can be greater for some individuals than others and may lead to chronic brain and immune system damage or death. IOM committees published reports in 1991, 1994a, 1994b, and 2012 and found that the following health problems are causally related to vaccination:● Acute encephalopathy (brain inflammation), Chronic Nervous System Dysfunction (brain damage), Anaphylaxis (whole-body allergic reaction), Febrile Seizures (convulsions with fever), Guillain-Barre Syndrome (peripheral nerve inflammation), Brachial Neuritis (arm nerve inflammation), Deltoid Bursitis (shoulder inflammation), Acute & Chronic Arthritis (joint inflammation), Syncope (sudden loss of consciousness/fainting), Hypotonic/Hyporesponsive Episodes (shock and unusual shock-like state), Protracted, Inconsolable Crying and Screaming, Vaccine Strain Infection (smallpox, live polio, measles, varicella zoster vaccines) & Death (smallpox, live polio, measles vaccines). ● IOM published a report in 2012 revealing that there were significant gaps in scientific knowledge about the biological mechanisms of vaccine injury and death, a point that was made two decades earlier in 1991 and 1994 IOM reports. Because there are not enough methodologically sound epidemiological and biological mechanism studies evaluating vaccine adverse events, the IOM committee could not come to definitive conclusions about causation for many of the reported vaccine reactions involving chronic brain andimmune system dysfunction and death. The Committee also concluded that some individuals are more susceptible to vaccine reactions for genetic, biological, environmental and other reasons that have not been fully identified. ● For eight routinely used vaccines (MMR, DTaP, hepatitis B, hepatitis A, varicella zoster and meningococcal) there were too few scientifically sound studies published in the medical literature to determine whether more than 100 serious brain and immune system problems are or are not caused by the vaccines, including multiple sclerosis, arthritis, lupus, stroke, SIDS, autism and asthma.● Both epidemiologic and biological mechanism research suggest that there are known and unknown biological, genetic and environmental high risk factors, which can increase “individual susceptibility” to vaccine reactions. These predispositions can include genetic variants (in human or microbiome DNA), environmental exposures, behaviors and illness or developmental stage, all of which can influence how a child reacts to vaccines and/or their specific components. Some of the predispositions may be detectable before vaccination, others are not. ● Evidence was found assessing outcomes in sub populations of children who may be potentially susceptible to adverse reactions to vaccines (such as children with a family history of autoimmune disease or allergies or children born prematurely) was limited and is characterized by uncertainty about the definition of populations of interest and definitions of exposures and outcomes● IOM published a report in 2013 that revealed the federally recommended birth to six-year old child vaccine schedule had not been fully scientifically evaluated and there was not enough scientific evidence for physician committees to determine if the childhood vaccine schedule is or is not associated with the development of the following brain and immune system disorders prevalent among children today, including, but not limited to Asthma, Atopy, Allergy, Autoimmunity, Autism, Learning disorders, Communication disorders, Developmental disorders, Intellectual disability, Attention deficit disorder, Disruptive behavior disorder, Tics and Tourette’s syndrome, Seizures, Febrile seizures, Epilepsy.
3. The emergency regulations and ACIP guidance make no provisions for “pre existing susceptibility” for a child. A doctor’s unfettered role in determining the student’s health and safety when vaccinating is so critically important and cannot lawfully be curtailed by a regulation.
In a 2012 report, the Institute of Medicine concluded that some individuals are more susceptible to vaccine reactions for genetic, biological, environmental and other reasons that have not been fully identified. However, the current DOH regulations and ACIP guidance make no provisions for “pre-existing susceptibility” for a child. In its 2012 report, the Institute of Medicine concluded that some individuals are more susceptible to vaccine reactions for genetic, biological, environmental and other reasons that have not been fully identified. However, the current DOH regulations and ACIP guidance make no provisions for “pre-existing susceptibility” for a child.
For illustration purposes of the insufficiency of relying solely on ACIP guidance, a three-month-old infant may contract a fever, collapse or enter a shock-like state, have seizures, and cry inconsolably for more than three hours after vaccination with DTaP but would not have a contraindication to additional doses of DTaP per ACIP guidelines. The same infant could have a sibling that died as a result of DTaP or have cerebral palsy and would still not have a contraindication to DTaP per ACIP guidelines. However, under these circ*mstances, a treating pediatrician should clearly utilize independent deliberation in conjunction with ACIP standardized guidance by duly exercising his or her training, education, and experience and accounting for the child’s unique circ*mstances in determining if additional vaccination may be detrimental to the child.
These regulations obscure the physician’s role as the “learned intermediary” in determining the safety and appropriateness of the vaccination for the patient\student that is allowable by statute PHL §2164 (8). These regulations upend the entire purpose of our health care industry by allowing an appropriately licensed physician or specialist to direct the care and treatment of his/her patients, along with his patient’s parents for informed consent.
4. To comply with these emergency regulations, schools are over-ruling the opinion of a child’s treating physician that immunizations may be detrimental to their health. It is inappropriate for anyone other than the treating physician to determine who should be allowed to get a medically-necessary exemption. Otherwise, this raises serious legal and ethical considerations, including:
● Ethically, how can a physician who has sworn the Hippocratic oath to “first do no harm,” immunize a child after deeming immunizations unsafe for that child?● Legally, who would be liable when the vaccines cause that child foreseeable yet preventable harm?● Ethically, how can a parent who has been entrusted by God with that child, choose between their child’s health or their child’s education?● Legally, how can NYS DOH or any school district effectively force a parent to make that decision, and how are they able to commit educational and medical discrimination against that child?● Legally, how can the NYS DOH grant authority to a school principal, leader or designee, who does not have adequate medical training or expertise, to choose to uphold the recommendation of one physician who has never examined the child while choosing to reject the recommendation of the child’s primary medical provider.
5. The Emergency Regulations violate Public Health Law §2164:
The emergency regulations conflict with Pub. Health Law § 2164 (8), which defines a medical exemption as follows:
“If any physician licensed to practice medicine in this state certifies that such immunization may be detrimental to a child’s health, the requirements of this section shall be inapplicable until such immunization is found no longer to be detrimental to the child’s health.” (emphasis added.)
The emergency regulations conflict with Public Health Law, as follows:
● Section 2164 (8) of the Public Health Law is clear—a child shall be exempt from vaccination if the vaccination may bedetrimental to the child.● The statute does not require proof that a vaccine isdetrimental to a child’s health (i.e., that a child suffered previous harm from a vaccine) before a child is entitled to a medical exemption. In contrast, ACIP contraindications for every vaccine require harm after a previous dose.● Under the most liberal of interpretation of PHL 2164 (8), the statute does not require a doctor’s medical opinion agree with, or comport with, the ACIP guidelines, as a prerequisite for obtaining a certified medical exemption available underPHL 2164 (8), that is now required under the emergency regulations.● These new rules promulgated by NYS DOH violate the statute PHL 2164 (8), and a patient’s right of informed consent, and the well-established New York “learned intermediary doctrine” defining a doctor’s role in determining vaccine safety and efficacy for the student.● Nowhere can it be found in any case law or state or federal statute, that a licensed physician is limited to giving a medical opinion for his patient to obtain a medical exemption, to only instances when the medical opinion comports with ACIP guidelines, other than in the emergency regulations.● If the legislature intended to further restrict the medical exemption to only medical certifications that rely solely on ACIP guidelines, the legislature would have done so. This emergency regulation is in violation of the legislature’s intent of Public Health Law § 2164 (8) and is a clear overreach of power by NYS DOH.
I implore you to consider these five essential points when deciding whether or not to renew or adopt these illegal and unethical emergency regulations. In addition to overseeing public health, you also have an equally important duty to safeguard the medically vulnerable children of this state and to preserve the authority and expertise of a licensed physician, so that the infrastructure of our children’s medical care remains intact and not overseen by the government. Thank you for your attention to this critical matter.
