Brook Jackson is the Ventavia clinical trials manager who contacted FDA in Sept'20 to report violations of clinical trial and patient safety procedures at two of the Texas sites where Ventavia for Pfizer were recruiting people to administer Pfizer’s products throughout Summer '20

FDA ignored her reports on the conditions in the clinics & reported her whistleblower contact to Pfizer. Pfizer sent attorney Barnes on Jackson in Oct'20. In Jan'21 Jackson filed a federal complaint under the False Claims Act at District Court, Eastern Texas. (1:21-cv-00008-MJT)

The BMJ interviewed her. bmj.com/content/375/bm

Pfizer filed a Motion to Dismiss on 22 April'22 “..the agreement was not a standard federal procurement contract, but rather a ‘prototype’ agreement executed pursuant to 10 U.S.C. § 2371b[.]…"

The [contract’s Statement of Work] describes a ‘large scale vaccine manufacturing demonstration’ that imposes no requirements relating to Good Clinical Practices (‘GCP’) or related FDA regulations.” The whole point is that under the EUA GCP regulations aren't required.

"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?" phmpt.org/pfizers-docume

"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?"

"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."

"The shots are classified as Emergency Use Authorization “countermeasures,” under the Project Bioshield Act of 2004 amendments to the 1938 Federal Food, Drug and Cosmetics Act and the 1944 Public Health Service Act."

"This means that under 21 USC 360bbb-3(k), they are by Congress's legal definition, not part of any “clinical investigation,” despite the fact that the Phase 3 clinical trials will not be finished for two years at the earliest." law.cornell.edu/uscode/text/21

“(k) Relation to other provisions - If a product is the subject of an authorization under this section, the use of such product within the scope of the authorization shall not be considered to constitute a clinical investigation.."

"..for purposes of section 355(i), 360b(j), or 360j(g) of this title or any other provision of this chapter or section 351 of the Public Health Service Act [42 U.S.C. 262].”

Exemption 355(i) x.com/InfiniteCyclus

Cyclus
@InfiniteCyclus

Mar 06 23

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"If a product is the subject of an authorization under this section, the use of such product within the scope of the authorization shall not be considered to constitute a clinical investigation for purposes of section 355(i)” law.cornell.edu/uscode/text/21

Exemption 360b(j) x.com/InfiniteCyclus

Cyclus
@InfiniteCyclus

Mar 06 23

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360b(j) law.cornell.edu/uscode/text/21

Dave
@rubrogram

Mar 06 23

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I find it telling that you don't know the difference between GMP and GCP... enago.com/academy/unders

360j(g) x.com/InfiniteCyclus

Cyclus
@InfiniteCyclus

Mar 06 23

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"..or 360j(g).. law.cornell.edu/uscode/text/21 ..of this title or any other provision of this chapter or section 351 of the Public Health Service Act [42 U.S.C. 262].”