The FDA has lost its way; parents must call the shots

FDA uses “parent choice” to override safety concerns.

The FDA language of parent choice is a lie. The message that parents need to be given the choice to vaccinate, just like the people who choose not to vaccinate get to exercise their choice, is a false comparison. There is no choice when choice is not informed. There is no choice when dangers are hidden and “messaging” is more important than data. There is no choice when compliance is coerced by fear of disease, financial loss, or segregation and bullying.

The fact is that the younger the child, the more parents make the choice not to vaccinate. The trend has nothing to do with access. It has to do with safety concerns that the FDA is ignoring. Parents must protect their children, because the FDA will not.

At the Vaccines and Related Biological Products Advisory Committee (VRBPAC) meetings on June 14-15, 2022, the panel voted unanimously in four separate votes to reach the White House goal of FDA Emergency Use Authorization (EUA) of COVID shots for both Pfizer and Moderna for kids as young as 6 months. Members went out of their way to declare their “yes” vote was about making sure the choice on whether children get the COVID shots is in the hands of the parents.

The FDA’s mission

The Food and Drug Administration is responsible for protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices; and by ensuring the safety of our nation’s food supply, cosmetics, and products that emit radiation.[i]

The FDA is supposed to regulate the safety and efficacy of drugs and vaccines that are sold in the United States. Period. No one questions that. But what happens when they don’t? What happens when the FDA fails in its duty to protect Americans?

The FDA has lost its way. Parents must call the shots.

Doctors rely on the investigations by FDA reviewers and advisory committees. Parents want to be able to turn to both doctors and the FDA to do their jobs to keep our families safe. But they can’t do that when health providers and regulators can’t meet at least a minimum level of scientific and medical believability and reliability.

Why aren’t doctors and the FDA curious about the monumental number of injuries that have been reported to the Vaccine Adverse Event Reporting System (VAERS)? Why are they not questioning the need for a COVID shot for kids when it is openly acknowledged by the FDA and the CDC that around 75% of children already have antibodies?

The FDA is not living up to its task – and it hasn’t for decades – as a recent Stand for Health Freedom blog revealed. The FDA is willing to “embrace uncertainty” with our children’s safety to push new pharmaceuticals to market. This is not new. As with Tamiflu, the FDA is willing to ignore fraud and faulty science while allowing unsafe and ineffective pharmaceuticals to be given to children and adults.

VRBPAC member Pamela McInnis was very clear her “yes” votes had nothing to do with safety nor efficacy, when she reminded everyone, “An EUA doesn’t certify that a vaccine is safe and effective.”

This begs the question: Why would a shot be authorized for emergency use if it hasn’t been proven necessary, safe, or effective?

The FDA made it clear that messaging, not safety, is their top priority and that they are passing the responsibility for risk assessment to parents.

Playing on fears has been a huge part of the COVID shots discussion. Health agencies call it “messaging”. Messaging has been a huge part of the discussion of both FDA’s VRBPAC and the Advisory Committee on Immunization Practices (ACIP) for the CDC. How does the government get people from hesitant or opposed to the COVID shots to accepting the “new normal” of multiple shots and boosters each year?

William Grueber opened Pfizer’s presentation with concerns of compliance with a three-dose series. His job was to present Pfizer’s safety profile.

When explaining his vote to recommend COVID shots for infants and toddlers, Dr. Arthur Reingold declared: “My personal preferred wording is not to tell people something is safe. I think that’s the wrong messaging. I think nothing in life is perfectly safe – no drug, no vaccine, no personal choice to get on a plane or get into a car is, quote, safe. I think what we need to emphasize is its benefits outweigh the risks.”[ii]

Dr. Oveta Fuller reminded parents that the trials for these shots are ongoing even after millions of American children are being injected, and that parents must decide whether their children should participate. “The need for clear messaging to parents and guardians about the choice for having the vaccine or not is very important and that the follow-up studies that are planned are very important,” she said. “…I would ask, should this pass, or should this be recommended by FDA advisory committee and passed by FDA and CDC, that parents really consult their pediatrician for their children…This is a decision that parents and grandparents and guardians will have to carefully weigh should this actually go through.”[iii]

This attitude of treating children as medical experiments has echoed throughout discussions since 2020. It has been more important to authorize shots quickly and collect safety data later on in our children, than to proceed with caution. Dr. Arthur Reingold emphasized the differences in priorities between parents and the FDA, saying, “One of the speakers in public session urged us to think of the children. Now I think he and I may think of the children in slightly different ways.”

To drive home the point, Dr. Ofer Levy explained safety surveillance after authorizing the shots was “key”.[iv] He said, “It’s possible we’ll see febrile seizures as this gets pushed out,” as well as other respiratory complications, “so those are areas where I think that knowledge, it needs to continue to evolve.” Read that again. the FDA’s “knowledge” of adverse reactions “needs to continue to evolve.” How does that weigh on a parent’s risk-versus-benefit scale?

Further, authorizing shots to appease fearful parents is reckless in a time where a growing number of states are allowing minors to make medical decisions without parental knowledge or consent. In December 2020, when VRBPAC considered the first COVID shot EUA for Pfizer, there was discussion about whether kids 16-18 should be included. Dr. Chatterjee stated the teens “would not be granting permission themselves. Their parents are responsible.”[v] No one disagreed.

When the FDA has a policy of shots first, questions later, parents must protect their children!

It was clear that whether the Moderna and Pfizer COVID shots for kids as young as 6 months would be recommended for FDA approval was never in question. Dr. Archana Chatterjee pointed out that she cast a “no” vote on a previous EUA expansion “and got in a lot of trouble for it.” To open discussion about the trials in children as young as 6 months, Dr. Arnold Monto reminded all the VBRPAC members of why they were there and who was in charge: “I’d like to call on Dr. Peter Marks, the Director of the Center for Biologics Evaluation and Research of the FDA to give us his welcome and tell us a little bit about what we are expected to do today.[vi] (emphasis added) Dr. Marks heads the section of the FDA responsible for investigating the COVID shots, a post previously held by Dr. Marion Gruber until she publicly disagreed with the booster agenda in September 2021[vii] and was swiftly removed from heading the Pfizer COVID shot review. She then unexpectedly retired from the agency in October 2021 after a 32-year career.[viii] Before the first vote to expand the EUAs for shots down to our youngest, Dr. Monto reminded members again, “I’m glad to give you the final word that we should all get vaccinated … OK we are ready for the voting question.”

Americans do not need to dig deeply into the employment rolls of the FDA to notice that people who slow or try to prevent drugs coming to market are not welcome at the FDA. The FDA cannot be trusted, and parents need to protect their children.

Parents do not need to have a Ph.D., M.D., or any other letters behind their names to make medical decisions for their child. No one knows a child better than the people who love them most. No one is more attuned to their needs, and no one is more invested in seeing them thrive. When it comes to medical decisions, your job as a parent is to ask questions until there are no more to ask. If a provider can’t answer, you ask another provider.

Justine Luzzi, who was excited to get her Moderna shots, developed vaccine injury after her second shot. In public comment she summed up the FDA’s role in allowing toxic COVID shots to be given to millions of Americans: “You are the ones that lie to the American people that vaccines are completely safe for the average person. You are offensive to actual science and medicine, lacking any type of curiosity of adverse events. … How do you sleep at night? You are a disgrace to humanity. You are narcissists cloaked in healer’s clothing. … Myself and millions [of] others will never stop fighting and telling the truth. Our resilience is bigger than your cowardice. Only cowards would avoid accountability as innocent people suffer. Approving this for children without fully researching the adverse effects is nothing short of criminal, extremely wicked, and shockingly evil.”[ix]

Parents must call the shots on their children’s health.

We know from comments that VRBPAC doesn’t believe that it is necessary to address safety concerns before the FDA allows a product to be used in the United States. Dr. Levy said he thinks the question needs to be whether benefits outweigh the risks. So how does the FDA evaluate benefits of a pharmaceutical product? It can’t be efficacy, as we see extremely low efficacy, breakthrough cases of COVID, quickly waning immunity from the shots, and acknowledgement that there is so little data it’s impossible to tell how effective the shots will be. So, what benefit does the FDA see that could outweigh risks they are ignoring?

Dr. Sawyer noted that many parents who made comments about wanting authorized COVID shots for their kids under five were isolating their children beyond even the federal government guidelines. There’s a huge mental health impact from this kind of isolation, so a “benefit” of the shot in his eyes is, “The availability of these vaccines will liberate these children to some extent whose parents will find relief and feel a little bit more comfortable as their children start to socialize in the appropriate environment.”[x] In other words, many parents are so scared out of their minds about the “messaging” the FDA and media have been streaming daily to Americans for 2 1/2 years that they are harming their children’s mental health, and the way the FDA will address this is by allowing these scared parents to “choose” to inject their children with an experimental pharmaceutical product with no proven safety or efficacy. This is absolutely not a scientifically- or medically-based benefit.

Coercion is not informed consent.

There’s no way for a parent to give truly informed consent to these shots for their kids. Information is coming to light in landslides about suppressed information and manipulated studies. It’s unclear if even the FDA itself has all the information necessary to make a decision on safety and efficacy.

By painting a picture of authorization in the name of parental choice, the White House, through its federal agencies, is engaging in manipulative mental Jiu-Jitsu.

With access to the shots for babies and toddlers, parents’ hands will be just as tied as the VRBPAC members.

Thanks to the FDA’s unwillingness to do their jobs and investigate safety concerns as a threshold matter to access, parents need all the facts to make the risk-benefit analysis for themselves. This fact alone compounds the risk of the product right out of the gate.

In addition, parents are contending with potential financial losses through job loss or needing to change schooling. They’re faced with putting a target on their child’s back that says “unvaccinated” to face bullying and discrimination. These are real concerns. One child in a Chicago school killed himself because other students wrongly labeled him as unvaccinated and school officials did not step in to stop the bullying.[xi] There are places and activities around the country that prohibit children from participation if they are not vaccinated. This is nowhere near a “simple decision to not vaccinate” as one VRBPAC member said, and many scared parents echoed this in their public comments.

The public comments aired by VRBPAC were sharply divided. Some parents pleaded or demanded the authorizations, with statements like:

“Our government has abandoned the youngest children,” said Nicholas Giglia, with two kids in COVID shot trials. Another said the wait for authorization for shots in kids under five, “made me feel like vaccinating my kids was not a priority for the FDA.” Yet another said that American parents with kids under five were forced to “hang on white knuckled only to be continually left behind.”

COVID shots will go on the Childhood Immunization Schedule.

The FDA has had an eye toward putting the COVID shot on the pediatric schedule from the beginning. It was mentioned at the first VRBPAC meeting to look at the Pfizer shot in December 2020 before the FDA granted the first COVID shot EUA. There was debate over whether the shot should be approved for 16–18-year-olds. Members had concerns that there wasn’t enough safety data. Dr. Levy argued, however, “if we take away the 16and 17-yearolds here, we lose what is the effort to climb down in age eventually.” The reason behind this was that the FDA needed to collect more data on younger children more quickly. Authorizing the COVID shot in order to collect safety data in the general population was the fastest way to authorization of the shot in all children, eventually getting the COVID shot on the pediatric schedule.[xii]

The curtain is being pulled back on the FDA, just like it was on the “great and powerful Wizard of Oz.” Now is the time for parents to take back control of their family’s medical choices. The FDA is reminding parents that there’s no place like home for health care decisions.

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Take Action

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Step One: The CDC couldn’t wait to call ACIP after VRBPAC’s recommendation to meet in emergency session this Friday, June 17, and Saturday, June 18, to give their vote to recommend COVID shots for our babies and toddlers. This is the time to use our voices! Make comments in the Federal Register for all Americans to see. You can post anonymously or with your name. You can be as short as you’d like or write paragraphs. The important thing is that Americans go on record showing their solidarity in health freedom and letting the White House know we are watching!

Click the button to be taken directly to the site for comments. Once there, find the blue button up in the left corner to leave your comment for the CDC, the White House, and the world to see.

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Step Two: Tell your governor to protect your family’s constitutional rights by standing up to federal overreach through public health agencies. The people can overrule the FDA and the CDC!​

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Step Three: Support your local health freedom candidates, from your backyard to your statehouse to your federal representatives. Download your state’s voter guide for the primaries and volunteer or donate to candidates who will stand up for your right to informed consent!

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References & Sources

[i] https://www.fda.gov/about-fda/what-we-do

[ii] https://youtu.be/Ixm4UmldTGQ?t=22892

[iii] https://youtu.be/Ixm4UmldTGQ?t=22862

[iv] https://youtu.be/Ixm4UmldTGQ?t=23170

[v] https://www.fda.gov/media/144859/download

[vi] https://youtu.be/Ixm4UmldTGQ?t=1553

[vii] https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(21)02046-8/fulltext

[viii] https://www.nytimes.com/2021/09/27/us/politics/fda-vaccine-regulator-peter-marks.html

[ix] https://youtu.be/GbNpaZeDPiA?t=20103

[x] https://youtu.be/Ixm4UmldTGQ?t=23084

[xi] https://www.theblaze.com/news/nate-bronstein-suicide-vaccine-lawsuit

[xii] https://www.fda.gov/media/144859/download (starting at page 387)

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Jill Hines

Directory of Advocacy
A former banker turned homeschool mom, Jill Hines began researching alternatives to conventional medicine in 2010 and what she discovered changed the trajectory of her life. She corrected a worrisome health issue, and embraced a natural approach to wellness. Advocating for informed consent and parental rights became a full-time mission when she joined the board of the Georgia Coalition for Vaccine Choice and later became the co-director of Health Freedom Louisiana. Due to her advocacy efforts during the COVID crisis, Jill was one of 25 Louisianans selected by Central City News as “a hero of the constitutional crisis.” She was also presented the Impact Award for Outstanding Public Service from the government watchdog organization Citizens for a New Louisiana. Jill now represents hundreds of millions of Americans who experienced censorship due to the Biden administration's efforts to suppress disfavored speech as a plaintiff in the landmark lawsuit Missouri v. Biden. Jill holds a marketing degree from Louisiana Tech University and now passionately “sells” health freedom full-time. Serving as Stand for Health Freedom’s advocacy director provides an incredible opportunity to advance the growing movement to preserve the sacred right to refuse unwanted medical interventions for ourselves and our children without fear of retribution.
“We have lived through a terrifying societal, psychological, and medical experiment which afforded us a knowledge that our forefathers tried to impart and we can no longer ignore: Our freedom is tenuous. For our children’s sake, the time is now to take a stand for health freedom.”

Chrissy Scott

Executive Assistant and Social Media Manager

A labor and delivery nurse with a lifelong passion for maternal and fetal health, Chrissy Scott left her job of 19 years after learning the truth about the harms caused by the medical system. In 2009, she was mandated by her employer to receive the H1N1 vaccine during her first trimester of pregnancy with her second child. She was assured that the vaccine was “safe and effective” for pregnant women, but her son was born with a kidney defect that could have been fatal. She didn’t connect the dots to vaccine injury until several years later when the declining health of her oldest son drove her to seek answers outside of allopathic medicine.

This personal journey ignited in her a new passion for truth and transparency in health care. As SHF’s Executive Assistant, Chrissy facilitates communication and local advocacy initiatives alongside Leah Wilson for their home state of Indiana. She also manages and creates graphics for SHF’s social media accounts and the website’s swag shop.

Chrissy earned her nursing degree from Anderson University and served her entire career at her local hospital. While she’s no longer a floor nurse, her five very active boys frequently test her nursing skills! She homeschools her children and has been co-owner of a successful home décor sign business with her sister.

“Parents, being the experts on their own children, are best suited to make decisions for the well-being of their family. To do this properly, they must be given full and accurate information and be free from force or coercion.”

Ellen Chappelle

Writer/Editor

Ellen Chappelle serves as SHF’s resident wordsmith. A seasoned writer and editor, she’s enthusiastic about ensuring that our content is clear, concise, and inspiring.

Ellen is most energized by working on projects that transform lives. A truth seeker as well as a journalist, she’s disturbed by the lack of accuracy in today’s media and determined to help share fact rather than fiction. And having found greater healing with alternative approaches, she’s also passionate about preserving our freedom to make informed health choices.

Past projects include serving as regional editor of a dog magazine, color and trend specialist for a small cosmetics company, arts columnist, newspaper reporter, ghostwriter, and creator of website content for artists and small businesses.

With a degree in journalism and theatre, Ellen is also a performer. She enjoyed singing and dancing on a cruise ship and traveling with a national musical theatre tour, as well as recording industrial videos, television commercials, and radio voiceovers. She also creates handcrafted jewelry in wire, chain maille, and fused glass.

“Despite what some would have us believe, the fact remains that this nation was founded on biblical principles by people who wanted freedom to worship God and live their lives without government involvement. It’s never been more critical to fight for those rights.”

LEAH WILSON

Executive Director and Co-founder

An attorney with a background in complex litigation and advocacy, Leah Wilson is passionate about children’s health and has researched and worked on child welfare issues for more than a decade.

The overmedication of children in foster care as a form of behavior management is what compelled Leah to become an advocate and foster parent. During her time as a court-appointed special advocate for abused and neglected children, Leah witnessed the rampant use of psychiatric drugs among foster kids. She also discovered that, in addition to many extensive requirements, the state had a policy that all foster children and foster families be fully vaccinated, without exception. Through her involvement in law, health and the foster care system, it became abundantly clear to Leah that the single most important issue affecting child welfare in the United States is the practice of one-size-fits-all medicine via medical mandates. This motivated Leah to expand her advocacy beyond foster care to all children nationwide and to start Stand for Health Freedom (SHF) in 2019.

A graduate of the Saint Louis University School of Law, Leah holds dual bachelor degrees in political science and Spanish from Indiana University. In addition to her advocacy work with SHF, Leah is the owner and former operations director of MaxLiving Indy, one of the largest natural health centers in the Midwest. She is also an educator on holistic health as well as a sought-after speaker on issues ranging from religious rights to greening your home.

“Parental rights and religious freedom are God-given natural rights that cannot arbitrarily be taken away by government authorities. Parents are the single most important factor in a child’s success; I stand in full support of this sacred relationship.”

Sayer JI

Director and Co-founder

Sayer Ji is a widely recognized researcher, author, lecturer, activist, and educator on natural health modalities. Among his many roles, he is an advisor to Stand for Health Freedom, a reviewer and editor of the International Journal of Human Nutrition and Functional Medicine, an advisory board member of the National Health Federation, a steering committee member of the Global GMO Free Coalition, and the co-founder and CEO of Systome Biomed Inc., a revolutionary scientific validation framework.

Most notably, Sayer is the founder of Greenmedinfo.com, the world’s most widely referenced, evidence-based natural health resource of its kind. He founded the platform in 2008 to provide an open access, evidence-based resource supporting natural and integrative modalities. Today, Greenmedinfo.com has more than a million visits per month, serving as a trusted resource on myriad health and wellness topics to physicians, healthcare practitioners, clinicians, researchers and consumers worldwide.

Sayer attended Rutgers, The State University of New Jersey, where he studied under the notable American philosopher Dr. Bruce W. Wilshire. He received a Bachelor of Arts in philosophy in 1995, with a focus on the philosophy of science. His new book, Regenerate: Unlocking Your Body’s Radical Resilience through the New Biology, was released in March 2020 and is an Amazon bestseller.

“I truly believe that education will be our greatest shield against accelerating the erosion of civil liberties, including the right to bodily sovereignty, as well as the greatest catalyst for positive change on this planet moving forward.”

Bailey Kuykendoll

Associate Director

Designer and visual marketer Bailey Kuykendoll began advocating for health and religious freedom and parental rights in 2014 after learning she was pregnant. A self-described skeptic, she’s not afraid to ask questions and do copious amounts of research to reach her own conclusions.

She’s also not afraid of hard work. As SHF’s Associate Director, Bailey truly keeps the organizational boat afloat. Working closely with our State Directors in each state, she ensures that SHF has calls-to-action for health-freedom bills and petitions on our website and across social media, spreading the word to encourage people to contact their legislators. She builds campaigns, graphics, website pages, and relationships.

Bailey earned a design degree from Harrington Institute of Design in 2008. She then served as a production assistant on several shows for HGTV, followed by working behind the scenes on the X Factor, small indie films, music videos, and documentaries. Bailey joined Health Freedom Florida after moving to the East Coast, becoming co-president of the grassroots organization in 2019. While at Health Freedom Florida, she successfully filed a state bill designed to stop discrimination based on your health status. She joined SHF in the fall of 2020.

“God placed a calling on my heart back in 2008 to be a part of something bigger for Him. Twelve years later, the opportunity came knocking to help others lean into their natural-born rights and take a stand for themselves and their families. I knew this is where I was called to be, and I have never looked back.”

Valerie Borek

POLICY ANALYST

Valerie Borek is a passionate advocate for health rights and family privacy. A mother of two with degrees in law and biochemistry, she is perfectly positioned to lead SHF advocates through complex health-rights policy. Her work is guided by a love for American values, uncovering truth, and a passion for empowering others. Valerie has served as SHF’s policy analyst since 2021.

Valerie’s understanding of the value of freedom to make one’s own health care choices is not just academic. Health freedom has kept her boys alive and thriving. Her choice to have home births jump-started her advocacy for health privacy. Her eldest son survived a rare and deadly cancer because her family was able to navigate medical care while holding onto values that were sometimes at odds with recommendations.

Before joining SHF, Valerie specialized in health and parenting rights at her boutique law firm, especially surrounding birth and vaccine rights. She advocated for informed consent in health care and transparent food labeling in her state. She helped found the Birth Rights Bar Association and was honored to present their argument to the Delaware Supreme Court that midwifery is not the practice of medicine, in support of a trailblazing midwife.

“Health is the foundation of how we show up in this world to love, serve, and create. Americans are blessed to live in a country that gets stronger the more we protect fundamental rights, like informed consent and privacy, so individuals and families can thrive.”

Mary Katherine LaCroix

DIRECTOR OF DEVELOPMENT AND NONPROFIT ADMINISTRATION

Mary Katherine LaCroix became involved with SHF as a volunteer in 2019 when the religious exemption for childhood vaccines was at risk in her home state of New Jersey. She believes strongly that parents have the responsibility for their children’s health, education, and faith formation and that only they have the right to make medical decisions and manage their care.

She has worked in fundraising for more than 25 years at various educational, cultural, human services, and political organizations. A graduate of the University of Scranton, she holds a degree in History and English Literature.

Mary Katherine is thrilled to have this opportunity to work with and help grow SHF, believing that together we can achieve even greater impact in protecting our rights and caring for our loved ones. She enjoys spending time with her husband, two children and large extended family, as well as volunteering to support the special needs community.

“Parents are taught that they must trust the experts. That’s what we did, until we learned that the experts can be wrong and don’t always know what is best for your child. Parents should instead feel empowered by their natural, God-given ability to advocate and care for their children. SHF is here to give them the tools to do just that.”

Sheila Ealey

Political Analyst

Dr. Sheila Lewis Ealey is the founder and former director of the Creative Learning Center of Louisiana, a therapeutic day school for children who are on the autism spectrum or struggling with other nonverbal intellectual disabilities. The wife of a former U.S. Coast Guard Officer, she is also the mother of four children. Her son was diagnosed with severe autism spectrum disorder at 18 months. He is now a young man and considered moderate and emerging.

Sheila and her twins were featured in the documentary “Vaxxed.” She has traveled extensively, advocating for medical freedom. She continues to educate disenfranchised parents about their fundamental rights to religious and philosophical exemptions, their ability to live sustainably on a limited budget, and the importance of nutrition and biomedical interventions for optimum health with autism. She also writes individual homeschool curriculums for parents of children with autism or intellectual disorders. Sheila is a trustee for the Autism Trust, USA, and on the board of directors of Children’s Health Defense.

Over the past 20 years, she has educated herself to use natural healing modalities for the body and brain. Her formal education includes degrees in communication, special education curriculum, and a doctorate in Educational Leadership in Special Education. Sheila serves as an assistant content advisor and political analyst for SHF.

“It is not the Constitution’s job to protect our liberties, as it is not a philosophical document but a legal one. Its purpose is to limit the powers and authority of our federal government in hopes of preventing an intrusion upon our unalienable rights. We are obliged to maintain our government within its limits.”

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