September 25, 2021

September 25, 2021

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

by | Jul 2, 2021 |

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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. Peter McCullough is an internist, cardiologist, epidemiologist, in academic medical practice in Dallas, Texas, USA. He maintains ABIM certification in internal medicine and cardiovascular diseases. He practices both internal medicines including the management of common infectious diseases as well as the cardiovascular complications of both the viral infection and the injuries developing after the COVID-19 vaccine.

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 46 peer-reviewed publications on the infection and has commented extensively on the medical response to the COVID-19 crisis in TheHill and on FOX NEWS Channel.

On November 19, 2020, Dr. McCullough testified in the US Senate Committee on Homeland Security and Governmental Affairs and throughout 2021 in the Texas Senate Committee on Health and Human Services, Colorado General Assembly, and New Hampshire Senate concerning many aspects of the pandemic response. Dr. McCullough has had one full year of dedicated academic and clinical efforts in combating the SARS-CoV-2 virus and in doing so, has reviewed thousands of reports, participated in scientific congresses, group discussions, press releases, and has been considered among the world's experts on COVID-19.

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