“The lower courts wrongly interpreted PREP as nullifying the North Carolina common, statutory, and constitutional law that would otherwise govern those activities and provide a basis for relief to the Plaintiffs, including laws concerning battery, parental rights, bodily autonomy, and informed consent.”

“We hope that the Court will determine that Congress did not close the courthouse doors to parents who are attempting to direct the medical care that their child receives. We simply want the Supreme Court of North Carolina to give us our day in court where we can present our case fully.”

This article was originally published by The Defender — Children’s Health Defense’s News & Views Website.

This article was originally published by The Defender — Children’s Health Defense’s News & Views Website under Creative Commons license CC BY-NC-ND 4.0. Please consider subscribing to The Defender or donating to Children’s Health Defense.

I would like to start by acknowledging what a tremendous responsibility it is to determine the right course of action for the 2020-21 academic year. I know that you have the health and safety of our students and staff as your highest priority and want to do everything in your power to handle this incredible task correctly.

Some of the measures announced by Governor Cooper as required are social distancing and wearing a mask while at school. I would like to raise some questions, as well as address some concerns, regarding these measures. Policies for education should always be weighed against the very real possibility of emotional stress, psychological strain and stunted social development. I fear that preventing our children from attending school full time and imposing severe protective measures to limit physical contact will cause physical and psychological harm.

Questions regarding mask use for school children

What masks are being suggested for school use—cloth or surgical masks? Has the FDA approved any masks for use specifically by children? Do you feel it okay to follow a mandate, when no safety studies exist on mask use for children? Additionally, the WHO states that people must not touch their masks, must change their single-use masks frequently or wash them regularly, dispose of them correctly and adopt other management measures. Is it really reasonable to expect school children to never touch, move or adjust their masks during the school day? I believe that any chance of protection is negated by the very active nature of the children.

Concerns regarding mask use by children and staff

In addition to the above unanswered questions, please consider the following:

• Penetration of cloth masks by particles was almost 97% and medical masks 44%.

• Moisture retention, reuse of cloth masks and poor filtration may result in increased risk of infection.

• Surgical masks reduce oxygen.

• Nationally-recognized neurosurgeon Dr. Blaylock says in relation to masks that “a drop in oxygen (hypoxia) is associated with an impairment in immunity….This sets the stage for contracting any infection, including COVID-19 and making the consequences of that infection much graver. In essence, your mask may very well put you at an increased risk of infections and if so, having a much worse outcome.”

Concerns regarding social distancing

Social distancing concerns shared by many parents have to do with the likely emotional and psychological trauma resulting from this measure. Children are much more in touch with their emotions than adults. They have an innate urge to interact with their environment. They use not only their eyes and ears, but also their sense of touch, taste and smell. Adolescence is one of the most formative life stages. It is a time when brains are most malleable and primed for learning. During this time, beliefs are formed, skills are developed and the way children perceive themselves and how they interact with the world during this stage plays a major role in defining who they become as adults. Have you considered the fact that if our children are short-changed on opportunities to grow, learn and develop as a result of social distancing restrictions, the impact may be psychologically damaging?

Hospitalization and fatality rates

Are children at risk? Are masks and social distancing measures justifiable? Statistically, children, preteens and teens 0 to 19 years of age have a probability of recovery of 99.9577% from COVID-19 infections. The odds of developing COVID-19 increase with age, starting at age 60. (6) School children are simply not an at risk group. The measures you are choosing to enforce will not provide protection, but will cause harm. Please reconsider and allow an option for the children to return to school without any restrictions, while implementing the following measures to protect staff and students:

• Staff and students should stay home, if sick.

• Effective hand washing should be taught and utilized.

• As with other school habits, students can “catch/cover their cough” as we have been taught for years in school.

Considering the fact that children are not an at risk group for COVID-19 infection, I ask you to preserve our right to choose whether or not our children wear masks. I ask you not to mandate social distancing measures for children in school. Let’s quarantine the sick and not the healthy! Our children need to be allowed to experience these formative years without the harmful restrictions of virtual learning, masks and social distancing.

Many North Carolinians are anxiously awaiting a COVID-19 vaccine because of the promise it holds to allow people to resume their normal lives, and several companies are rushing to get one to market. After much research, it has become apparent that the coronavirus vaccines being rushed to market are especially vulnerable to safety issues because:

• Historical attempts at a coronavirus vaccine were unsuccessful due to safety issues.

• Pre-marketing safety trials are insufficient because they are using inadequate sample sizes and short observation periods to watch for adverse reactions. In addition, double-blind, inert placebos are not required.

• Proper post-marketing surveillance is compromised by the rushed schedule.

• The pharmaceutical companies who will be producing the vaccine have been given immunity to lawsuits no matter how egregious their errors are.

I am writing to ask you to ensure that any COVID-19 vaccine rolled out in NC be properly studied for safety.

Prior attempts at a coronavirus vaccine unsuccessful: Dr. Peter Hotez, Dean of the National School of Tropical Medicine at Baylor College of Medicine, has stated that scientists have attempted to create a coronavirus vaccine for over 50 years and have been unable to produce one due to safety concerns related to “immune enhancement,” a condition in which vaccinated test subjects become gravely ill when exposed to the wild virus.

Dr. Hotez, who is typically a strong proponent of vaccines, has testified before Congress about the “unique potential safety problems of a coronavirus vaccine.” His recent animal studies for a coronavirus vaccine resembled the “immune enhancement” seen in research 50 years ago. Two children in that initial coronavirus vaccine study died.

Dr. Hotez told Reuters, “I understand the importance of accelerating timelines for vaccines in general, but from everything I know, this [COVID-19] is not the vaccine to be doing it with.”

COVID-19 Vaccine Safety Precautions VS. Safety Precautions for Other Pharmaceuticals

Non-vaccine pharmaceuticals are subject to safety protections such as: pre-marketing studies, post-marketing surveillance, and tort liability. Precautions for vaccines are lacking in all three areas.

Pre-Marketing Studies: Prior to marketing, non-vaccine pharmaceuticals are required to undergo stringent safety studies that include double-blind, inert placebo testing; large sample sizes; a lengthy observation of approximately 5 years; and testing on people who have poor health. Prominent vaccine researcher and promoter, Dr. Paul Offit, has said that trials for a COVID-19 vaccine should have “20,000 who get a vaccine and 10,000 who get a placebo. Then and only then will you know whether a vaccine is safe and effective.”

The COVID-19 vaccine studies fail to address many of these safeguards in testing. For example, in its phase 2 trial, Moderna, the current front-runner in the race for a COVID-19 vaccine, is using a sample size of only 600 people (compared with the 30,000 recommended by Dr. Offit); the follow up period is slated for 13 months; and study participants who are under 18 or have chronic health issues are excluded. Given that an estimated 60% of Americans have chronic health problems, and the vaccine is intended for all Americans (especially the frail), this trial represents a small percent of the people who will be required to take it.

A note about inert placebos: Moderna currently has committed to using an inert placebo in its phase 2 trials. However, unlike with other medications, vaccine manufacturers are not required to use an inert placebo [see item (1) here], and the FDA has allowed coronavirus vaccine manufacturers to back out of using inert placebos. For example, the vaccine currently under development by AstraZeneca initially provided that the control group would receive a saline placebo. After approving this study design, the FDA inexplicably approved changing the control from a “Placebo Control” to “MenACWY,” which is another vaccine for a bacterial infection unrelated to COVID-19. It is ethically and scientifically indefensible to use MenACWY vaccine as a control because its safety profile has never been established in a placebo-controlled clinical trial.

Post marketing surveillance: Once a pharmaceutical is on the market, drug companies conduct surveillance to document unexpected adverse events. Because the plan is to quickly distribute this vaccine to the maximum number of people, there will be little time to catch adverse reactions before millions of people may have incurred harm.

The introduction of the vaccine and its potential adverse side effects should not disproportionately harm members of one race over another. However, under the pretense of equity, Melinda Gates has stated that “black people...and many other people of color” will be the first in the general population to receive the COVID-19 vaccine because “they are having disproportionate effects from COVID-19.” Given the poor safety results in past coronavirus vaccine trials and the insufficient testing of the COVID-19 vaccine, it is unethical to prioritize people of color as the first recipients of a potentially hazardous vaccine. Some have said that vaccinating people of color first is too eerily similar to the Tuskegee experiments.

Tort Law Protections: With the exception of vaccines,pharmaceutical companies are liable for any injury caused by their products. This liability adds an additional layer of incentive for companies to produce a safe product. The US PREP Act waives all liability of pharmaceutical companies who produce a COVID-19 vaccine. This act along with the rushed timeline of development further erodes the safety profile of a COVID-19 vaccine.

We ask you to ensure that any COVID-19 vaccine introduced in NC receive proper safety studies and provide compensation to anyone who is injured, including:

• Use of a double-blind, inert placebo in safety studies

• A sample size of 20,000 participants and 10,000 who receive placebo

• An observation period of at least 1 year for adults, 3 years for children and teenagers, and 5 years for infants and toddlers.

• Testing of people of all ages and health statuses

• An NC-sponsored injury compensation program to offset the loss of tort liability protections created by the PREP Act

Thank you for addressing these issues.

North Carolina citizens, children and adults, are being told to wear a mask whenever they are around others. I am concerned that masks are also a source of risk that needs to be weighed in contrast to their limited benefit. I ask that you preserve our right to choose whether to wear masks.

The New England Journal of Medicine states that, "Outside of a medical setting, the wearing of masks provides little, if any, protection against the transmission of disease."

Experts have outlined numerous reasons that masks could actually increase the risk of infection. They allow germs to concentrate on the mask and increase the number of times people touch their face. One large study found that moisture retention, reuse of cloth masks, and poor filtration may result in increased risk of infection in health care workers wearing cloth masks.

Masks reduce oxygen and increase the risk of carbon dioxide toxicity. This is particularly concerning for people with asthma, COPD, and other respiratory issues.

Wearing a mask for long periods of time and trying to communicate with others is difficult. Adults and children alike may have difficulty interpreting facial expressions and being heard when masks are in use.

The choice to wear a mask is a personal one, and masks should not be mandated by either government or private entities. In addition, health departments should make the public aware of the risks and limitations of masks.

Thank you for your work as a public servant during these challenging times.

I'm writing to ask for public hearings about contact tracing which NC is instituting. Contact tracing has traditionally been done between a doctor and patient, protecting the privacy of the patient and those who had been in contact with them. Now, contact tracers are being hired across the nation and trained to do this work on their personal, home-based computers, using data collected from an app on citizens’ cell phones that traces individuals and groups to a particular location.

How will NC protect our privacy and personal medical information? It is unlawful for the government to use data to track individuals without a warrant. For government officers to use cell data to track people, they must have either express permission or a warrant for every single individual. (See Supreme Court case Carpenter v. U.S.)

What if only a small percentage of people are willing to share personal medical information on an app? Will NC mandate its citizens to comply? Washington State Governor Jay Inslee has indicated that people who refuse to cooperate with contact trackers or refuse COVID-19 testing won’t be allowed to leave their homes or will face sanctions in civil or criminal court.

These questions must not be decided by executive order. I ask that a public hearing be held including experts in the fields of constitutional rights, HIPAA privacy laws, computer security, and the public. This hearing would allow experts and citizens to weigh in on concerns, conflicts of interest and challenges to the primary goal of protecting the privacy and personal medical information of our citizens.

Thank you for taking my concerns into account.

Thank you for your service as an NC leader during these challenging times. We’re writing about issues with COVID-19 decision-making benchmarks being used by NC that you may not be aware of.

As you know, we were told that decisions about COVID-19 were being made to “flatten the curve” to protect the hospitals from being overwhelmed by a flood of COVID-19 cases. In trying to understand the criteria that NC is using, it was shocking to learn that hospital capacity is not one of the benchmarks being used for the decisions that impact our safety, our financial security, and our quality-of-life.

The NC Benchmarks are vague and lack focus on hospital capacity.

We now know that the death rate is a fraction of what was predicted (even with quarantine in place). The News and Observer reported on May 18 that NC is using the following four “trend” benchmarks and three “capacity” benchmarks to determine whether or not to loosen social restrictions. Hospitalization is listed as one of the four trends, but the most important issue is hospital capacity, which is not one of the three capacity benchmarks (which are testing, contact tracing, and PPEs.) Not only do these “trends” benchmarks fail to measure hospital bed availability, they are vague and are not focused on the small percent of people who will require hospitalization.

1. Lower the percentage of positive COVID-19 tests:  What kind of positive cases are they referring to here?  The real question is how many cases are severe enough to warrant hospitalization.

2. Level off the number of patients hospitalized by the virus:  Why isn’t this benchmark calculated in the context of hospital beds available? Mandy Cohen of NCHHS has stated that the state has plenty of available hospital beds, ICU beds and ventilators. Why isn’t that fact front page news?

3. Declines in the total number of lab-confirmed cases:  Again, what kind of lab-confirmed cases?  For example, suppose 1 person in a business becomes infected so all 100 persons in that company are tested and 20 of those people are positive but asymptomatic. In a short time, these 20 people are actually a benefit to society as they become part of the herd we need for herd immunity.   

4. Declines in the number of cases detected through patients with COVID-like symptoms being evaluated by health care professionals:  Why do we need to measure symptoms when people with COVID-like symptoms can get test results for actual COVID-19 infection in less than 2 days? 

The benchmark we need is hospital capacity.

North Carolina never saw numbers coming close to 7,987 beds and 862 bed shortage predicted for April 23. As of May 26, according to NCDHHS, among 78% of hospitals reporting in NC, there are 5,677 beds open in NC. On May 26, there were 621 patients hospitalized in NC.  This means that we could see a nine-fold increase in hospitalizations without overwhelming the system.

We ask that you demand concrete benchmarks tied to hospital capacity to justify decisions that impact our safety, our financial security and our quality-of-life. 

Thank you for your time.