Regulatory Science Off the Rails for the COVID-19 Vaccine Program

by | Jul 2, 2021 |

Print Friendly, PDF & Email

We have regulations in the pharmaceutical and device industry to ensure that medical products are safe and effective. The principles used are embodied in “regulatory science” which is a complicated discipline and represents the interface between companies, research organizations, universities, our US FDA, and you the medical consumer. 

We must have trust in the principles, the laws, and the enforcement of these laws to be sure that we are safe when we take medications or accept injections of vaccines or other medications.

There are six cornerstones of medical ethics that apply to research and the best known of these is the Nuremberg Code and the Declaration of Helsinki. These are the bedrock of how research is performed across the globe and for decades they have protected research subjects from harm due to medical products as well as research procedures. 

As we are now about halfway into the largest human research project ever performed in America, we find ourselves adrift in a sea of misinformation, deceit, and regulatory malfeasance. As a result, thousands of Americans have died and been hospitalized within a week of receiving investigational injections of genetic vaccines produced by Pfizer, Moderna, and JNJ. 

These products are on gene transfer platforms that have failed for other diseases and were rushed forward skipping all the usual testing for risks of cancer, birth defects, and genetic alterations. 

In this issue of the McCullough Report, we have a brief word from Mr. Anmol Ambani, from Mumbai, who will discuss his views on Covid-19 treatment in India. His family also owns and operates the Kokilaben Dhirubhai Ambani Hospital (KDAH) in Mumbai. This is followed by Anthony Kyriakopoulos, MD, Ph.D., from Greece who will tell us what mRNA is and where it goes in our bodies, and then what it does in our cells and tissues. Do these products fulfill the minimum standard of primum no nocere? This is followed by Ms. Stacey McIntosh, who is a regulatory expert and will help us understand regulatory science as it applies to COVID-19 vaccines.

Finally, we finish up with Mr. Kirsch who returns to The McCullough Report for another segment driving hard now on regulatory malfeasance. So get locked and loaded with this packed edition of The McCullough Report.

The McCullough Report: Sat/Sun 2 PM ET Encore 7 PM – Internationally recognized Dr. Peter A. McCullough, known for his iconic views on the state of medical truth in America and around the globe, pierces through the thin veil of mainstream media stories that skirt the major issues and provide no tractable basis for durable insight. Listen on iHeart Radio, our world-class media player, or our free apps on AppleAndroid, or Alexa.

 https://www.hhs.gov/ohrp/international/ethical-codes-and-research-standards/index.html
 https://pubmed.ncbi.nlm.nih.gov/33803295/
 https://www.linkedin.com/in/stacy-mcintosh-27089070/
 https://philanthropynewsdigest.org/news/covid-19-early-treatment-fund-supporting-outpatient-drug-trials

Dr. Peter McCullough

Dr. McCullough is an internist, cardiologist, and epidemiologist managing the cardiovascular complications of both the viral infection and the injuries developing after the COVID-19 vaccine in Dallas, TX, USA.

Since the outset of the pandemic, Dr. McCullough has been a leader in the medical response to the COVID-19 disaster and has published “Pathophysiological Basis and Rationale for Early Outpatient Treatment of SARS-CoV-2 (COVID-19) Infection,” the first synthesis of sequenced multidrug treatment of ambulatory patients infected with SARS-CoV-2 in the American Journal of Medicine and subsequently updated in Reviews in Cardiovascular Medicine. He has dozens of peer-reviewed publications on the infection and has extensively commented on the medical response to the COVID-19 crisis in TheHill, America Out Loud, NewsMax, One America News, Victory Channel, NTD, and FOX NEWS Channel.

On November 19, 2020, Dr. McCullough testified in the US Senate Committee on Homeland Security and Governmental Affairs, in 2021-2022, the Texas Senate Committee on Health and Human Services, Colorado General Assembly, New Hampshire Senate, Pennsylvania Senate, and South Carolina Senate concerning many aspects of the pandemic response. On January 24, 2022, Dr. McCullough co-moderated and testified in the US Senate Panel “COVID-19: A Second Opinion” chaired by Senator Ron Johnson. Dr. McCullough has reviewed thousands of reports, participated in scientific congresses, group discussions, and press releases, and has been considered among the world's top experts on COVID-19.

Subscribe
Notify of
guest
0 Comments
Inline Feedbacks
View all comments

Disclaimer: The information contained in this website is for educational, general information, and entertainment purposes only and is never intended to constitute medical or legal advice or to replace the personalized care of a primary care practitioner or legal expert.

While we endeavor to keep this information up to date and correct, the information provided by America Out Loud, its website(s), and any properties (including its radio shows and podcasts) makes no representations, or warranties of any kind, expressed, or implied, about the completeness, accuracy, reliability, suitability, or availability with respect to its website(s) or the information, products, services or related graphics and images contained on the website(s) for any purpose.

The opinions expressed on the website(s), and the opinions expressed on the radio shows and podcasts, are the opinions of the show hosts and do not necessarily represent the opinions, beliefs, or policies of anyone or any entity we may endorse. Any reliance you place on such information is therefore strictly at your own risk.

At no time, nor in any event, will we be liable for any loss, or damage, including without limitation, indirect or consequential loss of data or profits arising out of, in an association of, or connection with the use of this website.

Through this website, users can link to other websites that may be listed. Those websites are not under the control of America Out Loud or its brands. We have no control over the nature, content, or availability of those sites. America Out Loud has no control over what the sites do with the information they collect. The inclusion of any links does not necessarily imply a recommendation, nor does it endorse the views expressed with or by them.

Every effort is made to keep the website up and running smoothly. However, America Out Loud takes no responsibility for, nor are we, and will not be liable for being temporarily unavailable due to technical difficulties beyond our control. America Out Loud does not sell, trade, nor market email addresses or other personal data.

Genesis HOC1
CofixRX
Use the code ‘OUTLOUD’ and receive your 20% discount on your first order.
My Free Doctor.com
A House Built on a Foundation of Lies, Cannot Stand!

A House Built on a Foundation of Lies, Cannot Stand!

With today’s many avenues of communication open to free thinkers, it is a vain hope that the Democrats continuing program of lies and deceit can succeed, yet, they double down on their lies in open contradiction of actual facts that can no longer be hidden. And Biden’s White House for propaganda, French-born press spokesperson Karine Jean-Pierre, is the very face of…

PayPal’s Reinstated ‘Misinformation’ Policy Targets Conservatives – Time to Cancel PayPal

PayPal’s Reinstated ‘Misinformation’ Policy Targets Conservatives – Time to Cancel PayPal

When you read the fine print of “prohibited activities,” camouflaged deep within the content, you’ll find that “in PayPal’s sole discretion,” they can fine you if you “depict, promote, or incite hatred for discrimination of protected groups or of individuals or groups based on protected characteristics (e.g., race, religion, gender or gender identity, sexual orientation, etc.).”

With Great Courage, Dr. McCullough Fights to Keep his Board Certifications

With Great Courage, Dr. McCullough Fights to Keep his Board Certifications

Dr. McCullough has already been systematically stripped of three professorships, multiple editorial positions at academic medical journals, and a host of other professional memberships and benefits. All that remains of his long and distinguished career are his Texas Medical License and his Board Certifications in Internal Medicine and Cardiovascular Disease. Now the ABIM wants to strip him of his certifications…

COVID Death Protocols in America’s Hospitals: Call to Action

COVID Death Protocols in America’s Hospitals: Call to Action

Truth For Health with DrLee4America – As many as 1000 patients a day are dying using “COVID” protocols with a deadly cocktail of toxic drugs, ventilators, withholding fluids, and nutrition, in America’s hospitals. Shockingly, hospitals are paid incentives that can reach $500,000 or more per COVID patient by the US government. Join us Tuesday, Nov 1st at Noon ET for a Press Conference…

My Journey to Jesus – More Stories from the Marine Corps

My Journey to Jesus – More Stories from the Marine Corps

Staff Sergeant Martinez walked up and down our ranks, giving us an inspection. He took a special interest in me, and while staring in my face he reminded us that if a Marine gets a bad enough sunburn that he cannot perform his duty, he could get formally charged with destruction of government property (we were government property) – which could be a felony…

Transgenderism in Churches, Rejecting God’s Law

Transgenderism in Churches, Rejecting God’s Law

Whistleblower Report – We expose the shocking rise in transgenderism in churches across America, as more churches hold “PRIDE” events, including programs aimed at children celebrating Drag Queens. People of Faith, who follow Biblical teachings, are called to stand against this evil assault on God’s design of the human body, on our children, and on the family…

America’s Marxist Revolution Began in Kindergarten

America’s Marxist Revolution Began in Kindergarten

The noble story of human progress offered by the history of Western Civilization and America’s founding is being rewritten. Our art, music, and literature are being destroyed and banned. Our heroes are called racists, and even the Unifying Cause of our Nation’s founding – Liberty – is repudiated as “white supremacy.” We stand at the edge of an abyss, a people stripped of history, identity, or aspiration fit only for subjugation…

Air Force Pilot, Dr. Miarecki Replaces Tyranny with Truth on Military COVID Policies

Air Force Pilot, Dr. Miarecki Replaces Tyranny with Truth on Military COVID Policies

Such egregious, flagrant violations of military and civilian law by top DoD leaders have disastrous effects on military service members individually, but it is also a corrosive threat to the entire rule of law that is the very foundation of America. Department of Defense leadership, Congress, and the American people need to be made acutely aware of these violations…

First Time in History, Experimental Genetic Injections Recommended for Routine Childhood Vaccine Schedule

First Time in History, Experimental Genetic Injections Recommended for Routine Childhood Vaccine Schedule

In the US, these decisions represent many “firsts”:  1) First pandemic illness to be permanently added — what happens when COVID-19 essentially goes away? 2) First emergency use authorized products to join — what happens if they are not fully FDA approved in the future? 3) First products added without clarity on the dose, interval, and how to administer?

Tentacles of a Covert and Exploitative Propaganda Machine Compliments of the US Government

Tentacles of a Covert and Exploitative Propaganda Machine Compliments of the US Government

The plan took place with eyes wide open, for those who had time to look. Billions of dollars were made available for local jurisdictions in tandem with what the CDC termed “immunization cooperative agreements” in place around the country to increase vaccine uptake. Many businesses and community organizations, forced to shut down at the height of the pandemic, were gifted with large sums of…

The Drug Cartels and the New World Order

The Drug Cartels and the New World Order

To be fair, Mexican police and military, frequently victims themselves of cartel violence, are all but helpless in stemming the tide because, being poor, they are equally susceptible to bribes, just like Joe Biden and his family. While we recognize that the government of Mexico has been corrupted, we must realize as well that our own government is corrupt…

The Mass Confusion of Public Health vs Population Medicine

The Mass Confusion of Public Health vs Population Medicine

Access to healthcare is properly a public health issue, but medicating the population is not. The main reason that population medicine has been usurping the place of public health is probably primarily due to the fact that we have drifted away from the Hippocratic ideal of let food be thy medicine. Instead, the popular belief is that “health” comes from a pill bottle…

The Failure of Common Sense in Public Health

The Failure of Common Sense in Public Health

Ask CDC and the FDA what to do if you are sick with COVID-19, and they tell you to take drugs, lots of expensive drugs that don’t do much, like Remdesivir. Several studies have documented that Remdesivir is useless against COVID-19. Even the WHO tells physicians not to use it. Our government is telling us to do things that don’t work. It defies common sense…

Genesis HOC1
CofixRX
Use the code ‘OUTLOUD’ and receive your 20% discount on your first order.
My Free Doctor.com
America Out Loud 6 years

Your Source for Free Speech, Talk Radio, Podcasts, and News.

 

Here we take on the challenges of our generation so that we can preserve future generations.

iHeartRadio

The APPS are free; the mission is priceless!

Free APP

Podcast Networks

Apple Podcasts
Google Podcasts
Spotify
Pandora
Tunein
iHeart
Stitcher

Subscribe and Listen on Your Favorite APP

Our Columnists and Show Hosts

Bookstore

Apple Podcasts

Click for the full bookstore.

Truth For Health

Apple Podcasts

COVID Solution Summit

Apple Podcasts

Evacuating Americans & fully-vetted Afghan's at Risk - Help Us!

Apple Podcasts

Empowering and mentoring conservative trailblazers from Generation Z to win!

Apple Podcasts

Turning Point Action is Recruiting Precinct Chairs - Become a Grassroots Warrior Today!

Apple Podcasts

URGENT - KEEP NINE
Please join us to protect the Supreme Court:
Sign the Petition!

Apple Podcasts

The LATINO USA EXIT from the Democrat Party, click for details...

Apple Podcasts

Fighting corporate censorship and ensuring voter integrity...

Apple Podcasts

Support wounded and fallen police officers. The Wounded Blue.

Wounded Blue
Share via
Copy link