Faked Clinical Trials and 'Real World Evidence'

Jessica Rose: This took all day, and it is worth mentioning...More oopsies in the world of court-ordered released data:

Let us return together to the Pfizer documents released by the Public Health and Medical Professionals for Transparency found here.

The reader will note that there are a few listed Case Report Forms (CRFs) for specific sites where the clinical trials were taking place…

There are hundreds of Subject numbers missing…In the case of the Ventavia Research Group for site 1085, a mere 1.4% of Subjects are accounted for. Since Pfizer is under court order to release complete lists, what on earth is going on here? Are these the complete lists? If these are the complete lists of Subjects, then where did the data relating to the hundreds of other Subjects/participants go?

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Others have written about the missing case report forms/clinical record forms, including Arkmedic, in a comment at Gab:

They are missing the important bit. That is, that 97% of the patients are missing from the Clinical Record Forms (CRFs) files released in the first document dump. This is the clincher. So many people don't understand what it means but you have to.

There are only 10-15 patients in the clinical record forms (CRFs) for each of the four sites' forms released as part of the court orders [in Public Health and Medical Professionals for Transparency v. FDA]. Each site should have around 300 patients, because that is the number in the recruitment log.

They are NOT in a later dump because the court order was for the four biggest sites CRFs to be released first, which they did.

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In 2017, the US Department of Health and Human Services changed the 1981 definition of human subject in a clinical trial from a “recipient of a test article or control” to someone about whom data is obtained. 82 Federal Register 7149 et seq.

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Side note: I’m still unravelling the relationships between original and amended versions of 45 CFR 46A (Basic HHS Policy for Protection of Human Research Subjects); 21 CFR 50 (protection of human subjects under HHS-FDA product-based laws); 21 CFR 56 (protection of human subjects under FDA Institutional Review Board laws); 21 CFR 312 (protection of human subjects under FDA Investigational New Drug Application laws); 21 CFR 812 (protection of human subjects under FDA Investigational Device Exemptions laws), and any other laws that turn up, especially laws specific to military personnel.

From what I’ve seen so far, I think the laws were changed in January 2017, effective January 2018 2019, to strip researchers of informed consent responsibilities (telling people about the risks and benefits) and to strip subjects of informed consent rights (to be told about risks and benefits, and allowed to freely choose whether to accept the treatment or not.) 82 Federal Register 7149

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In October 2020, the FDA officials with the Center for Biologics Evaluation and Research Vaccines and Related Biological Products Advisory Committee said they would use several databases, including VAERS, to monitor safety and efficacy, pretending that the role of FDA is to protect public health.

But as Steve Kirsch, Jessica Rose and others have documented in brutal detail, FDA has failed to monitor safety and efficacy and refused to stop the campaign and pull the products off the market.

Why? Because FDA’s actual function is to coordinate the deployment of bioweapons to kill and maim as many people as possible. The legal package that ensures there are no human subjects with legal rights includes no active, public monitoring and no sound, public data collection. When combined with the acts themselves — injection with pharmaceutical products — being redefined as not clinical investigation once an Emergency Use Authorization is put in place by the FDA, no test subject has informed consent rights.

In other words, it’s worse than badly conducted studies (the Brook Jackson/Ed Dowd clinical trial fraud/corporate fraud/whistleblowing model), or studies that suppressed adverse reactions and deaths to fraudulently make the products appear less deadly than they are (the framework Jessica Rose, Steve Kirsch and others use).

There were no studies, or if there were, they were tiny, comprised only of the case files that have been released.

Or, perhaps they were conducted on 44,000 military personnel and their spouses and children, as suggested by Attorney Todd Callender, who, in an April 3, 2022 podcast interview, referenced Department of Defense project number C4591001, which appears repeatedly in the November 2020 Pfizer Phase 1/2/3 “study” protocol, to argue that the product development process originated as a DOD project and further, that manufacturers can change the ingredients throughout clinical trials.

Callender’s observations align with those made by Mike Yeadon, Craig Paardekooper, John O’Looney and others, that the different effects seen among populations given different batches are signs that bioweapons are being tested.

Callender, Yeadon, Paardekooper and O’Looney’s observations align with those of the Moderna process engineers who posted anonymously at 4chan in December 2020, about the unusual “small quantities of additions happening at manual step.” See Monica Hughes and Igor Chudov reporting for more information.

All of those observations relate to FDA’s authority to grant manufacturers waivers to Current Good Manufacturing Practices, without the resulting products being deemed adulterated or misbranded. See Federal Food Drug and Cosmetics Act, 21 USC 360bbb-3a(c), 2013 Pandemic and All-Hazards Preparedness Reauthorization Act (Section 564A).

Perhaps when the human subjects are military personnel, the CRF case report files are considered confidential as matters of national security.

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More likely, all the studies provided by the US government, including the Food and Drug Administration as the alleged regulator, and by the manufacturers, to the public, to support the aggressive mass-injection campaign, were faked.

More likely, there were no clinical investigations in the traditional sense at all: no screened and enrolled patients, no medical supervision during injections, no monitoring post-injection, no sound data collection and analysis.

If that’s true, then the only data collection is happening through alternative, FDA-endorsed “real-world evidence.”

They’ve been giving untested, unproven, unregulated, non-standardized injectable products to millions of people to see what happens, without actually collecting good data on what happens or using the data to protect people’s health and lives after rollout, by, for example, revoking the Emergency Use Authorizations, suspending the ‘vaccination’ campaign and recalling doses still on shelves.

See Federal Food Drug and Cosmetics Act, 21 USC 355g authorizing real-world evidence, defined as: “data regarding the usage, or the potential benefits or risks, of a drug derived from sources other than randomized clinical trials.” Passed by Congress, signed by President Obama, 2016 Cures 1.0 Act, Dec. 13, 2016 (Section 3022), during the lame duck period after Trump's election but before his inauguration, as Russiagate was ramping up.

Other documents in which the phrase real-world evidence appears.

• 2017/01 - FDA Guidance: Emergency Use Authorization of Medical Products and Related Authorities. EUA products can be authorized by FDA without traditional clinical trial data about safety or effectiveness. Efficacy standard is extremely low bar: "may be effective" in the opinion of the HHS Secretary.

• 2017/08 - FDA Guidance: Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices

• 2021/01 - Israel Ministry of Health contract with Pfizer, Real-World Epidemiological Evidence Collaboration Agreement

• 2021/09 - FDA Guidance: Real-World Data - Assessing Electronic Health Records and Medical Claims Data To Support Regulatory Decision-Making for Drug and Biological Products

• 2021/11 - FDA Guidance: Real-World Data - Assessing Registries toSupport Regulatory Decision-Making for Drug and Biological Products

• 2021/11/02 - Pfizer Third Quarter Earnings Conference Call Prepared Remarks

• 2021/11/08 - FDA Summary Basis for Regulatory Action. In this document, the contents of the Pfizer injections are redacted.

• 2021/11/17 - Draft Cures 2.0 Act - Real-world evidence appears 8 times.

• 2021/12/29 - Canadian CovidCares Alliance PowerPoint. Describes the CCCA data: "This evidence is a tool you can use. It represents a real opportunity to hold our leaders accountable as it is not opinion, or modelling, or real world evidence that can be dismissed or manipulated, but LEVEL 1 EVIDENCE from a randomized control trial."

• 2022/02/08 - Pfizer Fourth-Quarter and Full-Year 2021 Earnings Conference Call Prepared Remarks.

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This is why I think that fraud charges (corporate fraud, clinical trial fraud, consumer fraud) are not going to get anywhere: because all the things the US government, Pfizer, Moderna and Johnson & Johnson have done that would have been crimes (fraud, homicide, medical battery) have been legalized.

This is also why I think treason charges against sitting and former Congress members, presidents and Health and Human Services secretaries might get somewhere, and better match the magnitude of the horrors they've deliberately planned and unleashed together.

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Update May 9, 2022 - More evidence the clinical trials were faked, from JikkyLeaks.

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St. Monica, mother of St. Augustine