3% fraudulent trial data would not have stopped Pfizer COVID vax authorization, feds tell court

Does the U.S. government actually want to shut down litigation on behalf of taxpayers against Pfizer and its clinical trial contractors for submitting allegedly fraudulent data to get emergency use authorization (EUA) for its COVID-19 vaccine?

Even though the Department of Justice filed a "statement of interest" Oct. 4 supporting Pfizer's motion to dismiss the False Claims Act (FCA) lawsuit by trial site whistleblower Brook Jackson, the feds "took a middle road" in their argument, Jackson's lawyer Warner Mendenhall told Just the News in mid-October.

They could "dismiss our case at any time," since Jackson is a "relator" purportedly acting in the interest of the feds, he said. "I actually am not unhappy" because DOJ didn't object to Jackson responding to its filing.

"The unusual pleading by the United States suggests a split of opinion between the attorneys working the case and the Biden White House," Jackson's Oct. 27 response says, speculating the government convinced the court to seal the case for nearly a year "because of how seriously they took the pleadings as fully legally sufficient as plead [sic]."

The statement of interest "actually supports Relator's position that an FCA claim for fraud in the inducement can be maintained where the allegations create an inference that clinical trial violations could have 'altered FDA's approval or authorization decision,'" it says.

The U.S. has not formally changed its January refusal to intervene, which prompted the court to unseal the lawsuit by Jackson, who was fired as regional director of Texas trial site contractor Ventavia after reporting data integrity problems she witnessed to the FDA. 

Jackson accused Pfizer, worldwide trial manager Icon and Ventavia of "cutting corners" to secure billions from taxpayers and become first to U.S. market with a "misbranded vaccination which is potentially not as effective as represented." 

Facebook throttled a British Medical Journal investigation into Jackson's allegations and documentation, including recordings of Ventavia meetings, based on its designated fact-checker's claims that the reporting would not "disqualify" the overall Pfizer COVID vaccine trial.

The government's statement of interest claimed Jackson's lawsuit "does not plead a sufficient nexus between the alleged clinical trial violations and the alleged requests for payment from the Government to support such liability."

It accepts the validity of the "fraud in the inducement theory," which says a claim can be "false or fraudulent" even when the "underlying claim for payment is not false on its face, nor makes any false certification." The government does not rule out the viability of an FCA claim related to vaccine authorization.

But Jackson's suit doesn't allege that any provision in the "statement of work" — the U.S. Army Contracting Command's purchase agreement for 100 million Pfizer vaccine doses upon FDA authorization — "conditioned Government payment for the vaccine on Pfizer's compliance with the clinical trial protocol or regulations." 

That document makes clear that clinical-trial conduct is "out-of-scope," DOJ told the court, so any violations could not "give rise to a claim for express or implied certification liability."

The feds cited the absence of specific allegations that "the data from the Ventavia sites caused FDA to authorize the vaccine or that FDA would have revoked authorization had it known about the alleged clinical trial violations." The suit doesn't claim the FDA received "fabricated, inaccurate, or misleading data" such as "symptomatic participants who[m] Ventavia did not properly test for COVID-19 infection."

Even if Jackson had such specific evidence, the Ventavia trial sites represented only 3% of participants and cannot call into question the EUA, which was based on "the totality of scientific evidence available," DOJ says.

The government's filing "often supports the legal position" of Jackson, "including the essential role the drug safety, efficacy, and vaccination capability of the FDA rules played as a precondition for payment from the Defense Department," Jackson's filing says. 

"It would be nuts to suggest an unsafe, ineffective drug that vaccinated against nothing for nobody would get billions of dollars in taxpayer funds," it continues. If the "clinical trial protocol was egregiously broken, then the very basis upon which the EUA was granted would be irrelevant."

The government contradicts its claims by its very actions in the litigation, Jackson argues. DOJ "made several requests to extend its deadline to either intervene or allow Relator to continue independently," which shows it didn't believe that her complaint "was devoid of evidence."

DOJ's filing misstates the conditions of the FCA by claiming that Jackson must allege the Ventavia trial errors "actually" altered the FDA's issuance of the EUA. The statute only requires "materiality," which a 5th U.S. Circuit Court of Appeals ruling in 2009 defined as "the potential to influence the government's decisions." 

The government can't seriously argue that a 3% fraudulent data rate is not material to a potential EUA, Jackson's filing says. Moreover, the whistleblower has also "since obtained data from other contracted research companies demonstrating similarly flawed clinical trial data," it adds. "Such blatant fraudulent activity at one testing site should also reasonably raise suspicion over the accuracy of data produced at other sites."

DOJ itself has prosecuted clinical trial fraud, the filing notes, pointing to a February 2021 grand jury indictment against a Miami clinic for having "falsified the participation of study subjects in clinical trials" between 2014 and 2016.

Under the FCA's "plausibility" standard, Jackson only has to show "representative samples" of a fraudulent scheme to stop a motion to dismiss, she argues. Her complaint cited several, including the "unblinding of participants," Ventavia employees using their hands to "speed up the thawing" of frozen vaccine concentrate, second injections outside the 19-23 day protocol window and failure to report serious adverse events to Pfizer and Icon.

"Each act of fraud directly impacted the risk-benefit calculation, which is a key inquiry in granting EUA," the filing says. "Bypassing protocol taints results, period."