On Nov. 2, 2021, The BMJ broke the story of Brook Jackson, the regional director who blew the whistle on data integrity issues in Pfizer’s pivotal COVID-19 vaccine trial. Weeks later, documents were leaked supporting Jackson’s complaint about “falsified data.”
Among the leaked documents was an email, authored by a former federal agent in the FDA’s Office of Criminal Investigations (OCI), claiming Pfizer knowingly submitted fraudulent data to the FDA, and the agency responded by turning a blind eye.
To grasp the gravity of what is written in the email, it’s important to understand the role of OCI.
What Is OCI?OCI is the FDA’s criminal law enforcement arm. Much like a police force, it conducts criminal investigations of illegal activities involving FDA-regulated products and brings them before the Department of Justice for prosecution.
OCI consists of about 200 federal agents, hired from the US Secret Service, the FBI, or the Internal Revenue Service Criminal investigations unit. The agents are stationed throughout the US, as well as attachés in overseas posts, and have the same type of arrest authority as other federal law enforcement agents.
The unit was established by former FDA Commissioner David Kessler, off the back of the generic drug scandal in the late 80s. Kessler was determined to crack down on fraud after FDA employees were found guilty of accepting bribes from generic drug makers.
"What I care about most is restoring the credibility and the integrity of the Food and Drug Administration," said Kessler at the time," and the only way to do that is to focus on strong enforcement. We are going to enforce the law."
Since then, many OCI investigations have led to arrests, hefty fines, and imprisonment such as the recent sentencing of two clinical trial researchers in Florida for conspiracy to falsify data by making it appear as though subjects were participating in the trials when, in truth, they were not.
The Leaked EmailThe email, dated March 26, 2021, obtained by this reporter details the OCI officer’s observations about the FDA’s handling of Jackson’s complaint.
“Having worked at FDA, I see it as surprising, for many reasons, that the agency turned a blind eye to a company's knowing submission of fraudulent data,” wrote the OCI officer, whose identity is suppressed after signing a non-disclosure agreement.
The FDA “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,” added the OCI officer, acknowledging the FDA’s dilemma in “weighing the risk/benefit ratio.”
According to the email, the FDA had to decide if it served the public better to just approve a vaccine that had much greater efficacy than expected amid the emergency, or make a public issue of Pfizer’s data integrity problems and damage public confidence in the vaccine.
Notably, at the time, AstraZeneca had egg on its face after it released data from an “interim analysis” of its rival adenovirus vector COVID-19 vaccine, claiming 79 percent efficacy.
The trial’s own Data and Safety Monitoring Board called out AstraZeneca for deliberately releasing “outdated and potentially misleading data” and overstating the effectiveness of its vaccine, forcing AstraZeneca to post updated (and less impressive) results.
Reflecting on AstraZeneca’s actions at the time, the OCI officer still thought it was “a far cry” from the company “knowingly submitting false data” but remained concerned that this type of deception would only sow public doubt.
“The general public must be able to trust that the clinical results are valid to sell, approve or take medication,” wrote the OCI officer, quoting a Wall Street Journal article on the AstraZeneca event, adding that it was likely the vaccines were “still extremely likely to be safe and effective.”
“My point here is that instead of the regulators protecting the public, in our case, they were complicit in a fraud. 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,” added the OCI officer, who did not respond to requests for an interview.
Response to Leaked Email?This reporter reached out to the FDA for comment on claims that it turned a blind eye to fraudulent data, and what, if anything, had been investigated by OCI regarding Jackson’s complaint. The agency said, “The FDA does not comment on possible criminal investigations as a general policy.”
The FDA has consistently underplayed Jackson’s complaint. It has not made a public statement except to say that it had “full confidence in the data that were used to support the Pfizer-BioNTech COVID-19 Vaccine authorization and the Comirnaty approval.”
Those defending the FDA believe that even if there were data integrity issues at the three trial sites at the center of Jackson’s complaint, it would be unlikely to impact Pfizer’s overall trial results.
To be sure, I asked the FDA if it had performed a “sensitivity analysis” to determine if excluding data from the three trial sites would impact the overall trial results, but the agency would not comment.
In response to the leaked email, Pfizer made a statement which is published below in full.
Pfizer's Nov. 30 Statement
"Pfizer received communication from an anonymous complainant in September 2020 relating to a single clinical investigator site in Texas, USA. We conducted a thorough investigation into the issues raised in accordance with Pfizer's quality management process related to clinical research. Actions were taken to correct and remediate where necessary. Pfizer's investigation did not identify any issues or concerns that would invalidate the data or jeopardize the integrity of the study.
The company proactively notified the US Food and Drug Administration of the matter and informed the Institutional Review Board for the study.
The Pfizer-BioNTech BNT162b vaccine was subsequently approved by the FDA, EMA and other regulatory authorities based on the robust data submitted from the clinical program. The vaccine has been given to hundreds of millions of people worldwide following approval. Pfizer has a robust quality management system in place for all aspects of our clinical trials, as they are the foundation of our commitment to patient safety and the integrity of our trials. We take all concerns raised very seriously and thoroughly investigate them, and when necessary taking swift action to address challenges or issues."