letter-in-the-british-medical-journal-highlights-experts-who-say-fdas-oversight-of-covid-vaccine-trials-was-grossly-inadequate-to-the-point-of-endangering-public-health

Letter in The British Medical Journal Highlights Experts Who Say FDA’s Oversight of COVID Vaccine Trials Was ‘Grossly Inadequate’ to the Point of ‘Endangering Public Health’


TOP LINE

A new letter in the British Medical Journal highlights several experts who claim that the FDA’s oversight of the COVID-19 “vaccine” clinical trials was “grossly inadequate” and led to an “endangering of public health.” The letter specifically highlights the whistleblower complaints brought by Brook Jackson against Pfizer, which outline how the FDA failed to address significant problems with the pharma giant’s clinical trials including falsified data, unblinded patients, and inadequately trained vaccinators amongst many other issues.


Imprimatur means a lot to those whom can’t wrap their heads around the overwhelming data evincing worldwide-scale fraud by an unholy alliance between big pharma and big government in the context of the COVID-19 “vaccines.” Thankfully, adding serious—prestigious—ammo to the warnings shouted (often literally) by “anti-vaxxers” about these experimental injections is a new letter in the well-pedigreed British Medical Journal (BMJ) that cites several experts who refer to the COVID-19 “vaccine” trials as “grossly inadequate.” Critically, the letter also cites whistleblower claims, like those presented by Brook Jackson against Ventavia—a company that ran multiple clinical trial sites for Pfizer-BioNTech’s COVID-19 “vaccine.”

“Jackson, a regional director, had witnessed problems at three trial sites she was overseeing and complained to an FDA inspector about a range of problems including falsified data, unblinded patients, and inadequately trained vaccinators who were slow to follow up on adverse events,” the letter in the BMJ says. The letter, written by investigative journalist Maryanne Demasi, notes that an unnamed former staffer in the FDA’s Office of Criminal Investigations who “was… concerned about the agency’s failure to fully tackle Jackson’s complaint about falsified data” wrote in an email that “Having worked at the FDA, I see it as surprising, for many reasons, that the agency turned a blind eye [to Jackson’s complaints]… .” The former FDA staffer added that the regulatory agency “likely feared the criticism they undoubtedly would have received for holding up a vaccine (which they knew they would eventually approve anyway) at the expense of untold lives lost.”

“The lack of oversight was not an isolated case,” Demasi adds in the BMJ letter. Indeed, Demasi notes that “Regulatory documents show that only nine out of 153 Pfizer trial sites were subject to FDA inspection before licensing the mRNA vaccine.” Likewise, “only 10 out of 99 Moderna trial sites and five of 73 remdesivir trial sites were inspected.” (Remdesivir is a Gilead antiviral drug deployed as a medication for treating COVID-19 that has been shown to be highly dangerous and utterly ineffective in an ever-growing list of studies.)

Demasi adds that “experts have criticized the FDA’s oversight of clinical trials, describing it as ‘grossly inadequate’… [and say] the problem, which predated covid-19, is not limited to a lack of inspections but also includes failing to notify the public or scientific journals when violations are identified—effectively keeping scientific misconduct from the medical establishment.”

The letter also references David Gortler—a pharmacist and pharmacologist who worked as an FDA medical reviewer for four years (between 2007 and 2011), and who was also appointed as a senior adviser to the FDA commissioner in 2019-21—as saying the FDA’s lack of oversight has resulted in an “endangering [of] public health.” Gortler is also quoted in the letter as saying that “The lack of full transparency and data sharing [has not allowed] physicians and other medical scientists to confirm the data independently and make comprehensive risk-benefit assessments.”

The former FDA employee, who signed an NDA and did not respond to interview requests from Demasi, went on to write in his or her email that ” My point here is that instead of the regulators protecting the public, they were complicit. At the time, they may have been doing what they believed to be the right thing under extraordinary circumstances. But now, they may soon have some explaining to do.”

Demasi’s BMJ letter—which should really be read in full (linked again here)—goes on to highlight numerous other significant issues the FDA has had with oversight generally. The reporter claims the “FDA has a long history of failing adequately to oversee clinical trial sites,” citing a report from 2007 by the Department of Health and Human Services’ Office of the Inspector General that found “the FDA audited less than 1% of the nation’s clinical trial sites between 2000 and 2005… .” The same report “was [also] highly critical of the agency because it did not have a database of operational clinical trial sites.” Demasi also highlights a 2015 analysis conducted by Charles Seife, a professor of journalism at New York University, in which he found “significant evidence of objectionable practices” that were not caught by the FDA. These objectionable practices included things like “falsification or submission of false information,” “problems with adverse events reporting,” “protocol violations,” “inadequate or inaccurate recordkeeping,” and “problems with oversight or informed consent.”

In response to comments on the BMJ letter on Twitter, Demasi said that “The FDA publishes its inspection reports but the database is not comprehensive, nor are the reports proactively disclosed.” Demasi also noted that “FOIA’d reports often contain extensive redactions” and that the way drug trials are conducted in general—with drug companies funding and designing their own trials, as well as analyzing their own data for FDA approval—means there is “systemic corruption” in the way pharmaceutical drugs are approved in the U.S.

In the hour-long interview with independent journalist Ryan Cristián (a.k.a. The Last American Vagabond) immediately above, Jackson—who was fired from her role as Ventavia regional director for the COVID-19 “vaccine” trials just hours after she notified the FDA of her employer’s significant failings—offers a more nuanced, tangible sense of the mismanagement of the COVID-19 “vaccine” clinical trials—committed by both Pfizer subcontractor Ventavia as well as the FDA.

“[T]he clinical research coordinators, the vaccinators that were put into these positions [at the Ventavia clinical sites] were not qualified to be put into those positions,” Jackson tells Cristián. The industry veteran adds that on-site staff were “not taking care of patients in terms of monitoring them after they were vaccinated” and simply placed them anywhere they could “with no medical supervision.”

Jackson goes on to note that she and her colleagues at Ventavia “were not following our standard operating procedures in terms of emergency management in the event that there was a reaction” and even says that Ventavia was “falsifying” and “fabricating” data. Jackson goes as far as to state, unequivocally, that Pfizer and the FDA committed “fraud” during the initial COVID-19 “vaccine” trials.

At this point Jackson has already filed a False Claims Act Complaint against Pfizer and Ventavia claiming that the COVID-19 “vaccines'” FDA authorization “resulted from a deeply flawed clinical trial that violated FDA regulations” and that Pfizer “[has] profited from the COVID-19 pandemic at the expense of the United States and its citizens by abusing the scientific process.” Although, as would be expected, Pfizer has already filed a motion to dismiss the lawsuit, which, astoundingly, claims Jackson’s allegations are dead on arrival because the pharma giant didn’t need to follow FDA clinical trial regulations for its COVID-19 “vaccine” trial because it was not required by its contract with the Department of Defense (DoD).

In the excerpts immediately above from Pfizer’s motion to dismiss Brook’s lawsuit, we see that the pharma giant claims specifically that the contract between Pfizer and the DoD, nor invoices submitted by Pfizer to the DoD, “make any mention of the FDA clinical trial regulations” as they were not relevant to conducting the “vaccine” clinical trials. Pfizer also says that the scope of work (SOW) for delivering its COVID-19 “vaccine” “describes a ‘large scale vaccine manufacturing demonstration’ that imposes no requirements relating to Good Clinical Practices (‘GCP’) or related FDA regulations.” Meaning Pfizer was not obligated to follow critical clinical guidelines as laid out by the FDA when producing its experimental COVID injection.

Although it’s somewhat tangential to Demasi’s letter in the BMJ, as well as Jackson’s whistleblower claims, it should also be noted that a second whistleblower, Melissa McAtee, has come out against Pfizer regarding the way it manufactured its COVID-19 “vaccines.” McAtee claims that, just as Pfizer didn’t follow Good Clinical Practices during the clinical trials of its experimental injection, it also hasn’t followed Good Manufacturing Practices (GMP) while producing its actual COVID-19 “vaccines.” On the contrary, McAtee says that both Pfizer and the FDA have failed to address the serious violations she observed at her Pfizer manufacturing facility, including intentionally blacked-out windows and negligent site reviews by the FDA.

In the post immediately above featuring an interview with pharmaceutical industry veteran Sasha Latypova we gain what is perhaps the key insight into not only why Pfizer and the FDA have been so negligent in this case, but also how they’ve gotten away with their behavior as she makes it clear that—legally—all of Pfizer’s COVID-19 “vaccine” clinical trials and manufacturing output have only been a “demonstration” of the ability to produce the experimental injections; not a genuine effort to produce them as other pharmaceuticals are normally produced. This has meant that Pfizer and the FDA have been able to behave in a completely lawless manner without suffering any consequences.


Feature image: Tony Webster

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