Physician Outlook

Informed Consent and COVID-19


Learn about what informed consent means and the rights everyone has to understand what they put into their bodies. This article looks at the past and how lack of informed consent led to a poor outcome for many. Learn what you can do to help with this issue.

“To vax or not to vax,” that is NOT the question. The real question is do you have the opportunity to exercise informed consent and an individual right to choose. In other words, patient-centered medical ethics demand that you have the right to understand and choose each unique intervention separately based on its own merits and risks. This especially and urgently applies to COVID-19 treatments and mRNA and DNA experimental interventions. Without knowledge, understanding and acceptance, there can be no informed consent. It is my observation that there has been neither full disclosure nor true informed consent with regard to this experimental medical intervention being called a vaccine. 

Hippocrates of Kos, the legendary Greek physician, born 460 BCE, was one of the earliest physicians who taught “medical beneficence,” the Hippocratic oath and to put the patient first and to “do no harm.”His work, teachings and writings inspired informed consent, which empowers patients with complete decision-making authority.

In 1947 following World War II, the Nuremberg Military Tribunal established and ratified the Nuremberg Code. The trial found that the Nazi government, under Adolph Hitler, instituted a policy of conducting clearly cruel and unnecessarily painful experiments of dubious scientific merit on non-consenting prisoners like Jews, poles, gypsies, homosexuals and the handicapped. Part of the verdict defined “permissible medical experiments,” cemented the foundation of Informed Consent and began international jurisprudence and biomedical research ethics for the modern age.

In the early days of WWII in 1940, the US FDA, at the time a relatively new agency, approved a drug called DES, diethyl-sylbesterol, a syntheric form of the female hormone estrogen, for the indication of preventing miscarriage, premature labor, and related complications of pregnancy. At the time, and for years, it seemed to be effective and safe in pregnant women.However, by 1971, more than 30 years later, it was clear to researchers that the daughters of women who used DES were at a 40x greater risk of developing cancer of the cervix, uterus and vagina.

Prescriptions came to a screeching halt, regulations were passed by FDA against use of the drug, and the lawsuits continued for a generation. This is only one example of how our regulatory agencies have rushed to judgment and been wrong before.

Now, in mid-2021, at the tail end of the global viralpandemic of COVID-19, government, politicians, corporate entities, higher education institutions and media entities, empowered by FDA emergency use authorizations, are overwhelmingly endorsing, and even mandating, COVID-19 mRNA and DNA interventions. Sadly, we may have hyperspaced back to 1940, erased formal medical informed consent, along with your right to choose.

I know a 31 year old man whose wife was pregnant for the first time; an exciting, stressful and pre-joyous event. She was encouraged by CDC,media and her obstetrician to get the COVID-19 mRNA intervention during her first trimester. The first Moderna shot was minimally noticeable except for fatigue. The second shot was at 12 weeks of pregnancy. Three days later, an ultrasound revealed the fetal heartbeat had stopped. They got the devastating news that they now had to have their nonliving child-to-be removed by surgical procedure... traumatic. No one can say for sure whether the mRNA shot did or did not end this baby’s life, but the timing is suspicious, and should be raising red flags, cause for concern, and further investigation. It’s curious that the government does not seem interested in these critical questions when it comes to protecting public health, if that is indeed their true intention.

Correlation does not always mean causation, but all these events should be reported to the CDC’s Vaccine Adverse Event Reporting system, known as VAERS.Was the loss of the pregnancy reported to the injection clinic or VAERS directly? No. Most people, in addition to not getting all the facts necessary for true informed consent, are not instructed to report all side effects and observations to the clinic or VAERS. It has been reported that only 1-10% of potential side effects of any drug or procedure everget reported at all.

Every medical drug, modality or procedure has risks, benefits, and alternatives that must be disclosed for the individual patient to consider. Not only has this not been done for these mRNA and DNA interventions, but colleges and universities have joined the chorus of government, politicians, corporate entities, and mass-media in promoting only the perceived benefits. Billboards in Atlantic City promoting the vaccines tout “Safe, effective and free.” Other states are even offering financial rewards to patients who are vaccinated. The truth is that government incentives are a moral hazard. They not only are paying for the vaccines with taxpayer dollars, but are committing such moral hazard by subsidizing, advertising, endorsing and even buying the favor of injection, like in the Maryland and Ohio vaccine lotteries.

With all the overreaching federal and state government unconstitutional arm-twisting and threats, informed consent is not possible. It is contrary to informed consent to tell you that your family can’t be together, visit elderly relatives or celebrate holidays until you’ve been “vaccinated.” This arm-twisting is immoral, unethical and illegal when it comes to medical procedures authorized only for emergency use, particularly in cases with completely new and experimental technologies. These tactics are, in fact, forms of coercion and extortion.

Independent physicians are finding success with inexpensive home treatments that work against COVID-19 when started early. The government-media complex completely ignores early treatment, natural immunity by exposure, and herd immunity, even to these final days of the pandemic. They often attempt to block and discredit such treatments, often referring to them as “misinformation.” Experimental mRNA and DNA vaccines such as these would not otherwise be able to obtain emergency use authorization were these treatments to be validated, acknowledged, and available.

Young college adults have miniscule, literally one in a million, risk of serious hospitalization from COVID-19. It is up to you and your teen or young adult to decide if the increasingly clear health risks from the experimental vaccines are worth the minimal benefits. Those with previous COVID-19 history have a ten-fold risk ofside effects and complications if they get the vaccine. As of today, per colleagues Dr. Peter McCullough at Baylor and Dr. Harvey Risch at Yale and myself, giving these vaccines to those with previous COVID-19 is contraindicated, that is not to be done. Emerging data and experience contraindicates the FDA’s emergency use authorization.

Let me reiterate. It is not vax vs anti-vax, but mandates and coercion vs. informed consent and individual choice. Mandates, enticements and inducements are illegal, immoral and unjust, in the grand scheme. We must say NO to mandates and yes to informed consent and individual choice.

Here’s what YOU CAN DO right now: All colleges and universities have a posted policy of individual exemptions for their edicts. Please pursue individual medical exemptions and religious exemptions with each school in writing. Use the media, social media and your voice. When that fails, submit an appeal with physician or clergy consultations. If they resist, then talk to legal representation and initiate state and federal lawsuits, with the warning of class action if relief is not immediately granted. This will get their attention. Colleges and universities are aligning against students’ and parents’ individual rights, inappropriately acting as arms of the pharmaceutical industry and government when their focus should be on providing students with mechanisms for principled debate and quality education. We must hold them accountable, individually and together.

Our youth depends on us. Let’s lead by example! Thank you.

Speech given April 21, 2021 at Rutgers University-New Brunswick, NJ“Say NO to Mandates!” Rally

 

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