This article comes from “lifesitenews.com”
Falsehoods concerning COVID jab trials have caused profound damage to medicine, the entire public health enterprise, and to the disciplines of clinical research and regulatory affairs.
(Robert Malone) – As I wrap up the final chapters for the upcoming book “Lies My Gov’t Told Me: And the Better Future Coming,” I am having to grapple with many of the most difficult issues. And of those, the corruption and lies told concerning the documents submitted by Pfizer and Moderna as well as the subsequent responses by the Food and Drug Administration (FDA) weigh most heavily on my heart and soul.
“The secret of liberty lies in educating people, whereas the secret of tyranny is in keeping them ignorant” – Maximilien Robespierre, public statement (November 1792), quoted in Oeuvres de Maximilien Robespierre (1840), Volume 2, p. 253.
Just to recap, on May 30, 2021, I had published a piece on Trial Site News concerning the bioethics issues titled “Bioethics of Experimental COVID Vaccine Deployment under EUA: It’s time we stop and look at what’s going down.” I also composed another article that was published on May 28, 2021, entitled “Did Pfizer Fail to Perform industry Standard Animal Testing Prior to Initiation of mRNA Clinical Trials?” Of course, both Trial Site News and myself were slandered, defamed and gaslighted by “factcheckers” at the time, but we have all come to learn that these “factcheckers” are really just paid narrative reinforcers.
Here is a brief recap of the items that Media Bias/Factcheck cited as recently as January 23, 2022. Personally, I suggest that Media Bias/Factcheck is clearly a purveyor of disinformation. In my experience, Trial Site News is operated as basically an industry insider-focused publication, designed to address the needs of customers in the clinical contract research and regulatory affairs industry. The firm has no financial interest in promoting anti-vaccine propaganda.
Consistent with that focus, Trial Site News has recently published two comprehensive analyses of the non-clinical data package sections of the Pfizer and Moderna COVID-19 mRNA vaccine regulatory submissions. Speaking as someone who has been trained and has had decades of experience in non-clinical research, clinical research, and regulatory affairs (including submission and defense of multiple initial new drug (IND) applications to the FDA), as I read these articles I am impressed by the careful wording and step-by-step analysis provided by the author, who is a very experienced regulatory affairs professional.
These articles are worded using the precise technical language of someone who knows how to review and critique an IND. I have previously read many assessments by scientists, physicians, vaccine specialists, and other interested parties of the non-clinical sections of these IND submissions, and as noted above I prepared one based on the early disclosure by the Japanese regulatory authorities, but none have been as thorough and comprehensive as these two.
For those who are not regulatory professionals, the language may seem a bit odd and at times hard to follow, but this is the way we talk to each other, and that is the way these are written. By a professional, for professionals.
Reading the conclusions of both of these, which are essentially bookends to each other (one relating to the Pfizer package, the other to the Moderna package), I am struck by how far the FDA – and Centers for Disease Control and Prevention (CDC) – have fallen from their prior standards. The standards that I have been trained to respect, and to expect to be held accountable to. I feel the same emotional reaction to these articles that struck me when I did my editorial passes on the Robert F. Kennedy, Jr. book on “The Real Anthony Fauci”: depression. What have these bureaucrats done to my profession?
A story: I recently spoke at a high powered Washington, D.C. congressional insider group. Afterwards another clinical research professional came up to me and related that she and her colleagues had been watching me closely, that I had done a great job of “getting it right,” and then she dropped the bomb. “Dr. Malone, what are we ever going to do to recover from the damage that has been done to clinical research and regulatory affairs?” All I could say is that we must do our best to convey hope to others, but that I was at a loss. The FDA has basically destroyed the FDA. And the CDC has destroyed the CDC.
I am trying to broadcast a message that it can once again be morning in America. But from time to time, it gets hard to be a happy warrior. This is going to be a hard lift, there is no doubt of that. And the damage to medicine, the entire public health enterprise, and to the disciplines of clinical research and regulatory affairs has been profound.
These two articles may be difficult reading for the uninitiated, as the wording is a bit foreign to the untutored reader. But even harder for those who can understand the nuances, and have spent decades getting trained and practicing their craft in these areas. The titles barely scratch the surface of the profound corruption which they reveal.
