British Medical Journal (BMJ) reported that Pfizer falsified the Phase III trial data that formed the basis for the emergency use authorization by the FDA
On Tuesday, The British Medical Journal (BMJ) released a report titled, “Researcher blows the whistle on data integrity issues in Pfizer’s vaccine trial.” The report suggests there is ample evidence that Pfizer’s phase III clinical trials were poorly managed and data was falsified, according to a whistleblower, while the Food and Drug Administration (FDA) apparently took no action and ignored concerns addressed to them.
The BMJ report also includes damning evidence including audio recordings, emails, internal memos, and photos from a former regional director, Brook Jackson, at Ventavia Research Group, where Pfizer trials were being held in Texas in the fall of 2020. The report further states that “Revelations of poor practices at a contract research company helping to carry out Pfizer’s pivotal covid-19 vaccine trial raise questions about data integrity and regulatory oversight.”
While Pfizer’s chairman and chief executive, Albert Bourla, was touting the company’s mRNA vaccine in 2020 to the billions of people around the world as a safe and effective covid-19 vaccine to end the pandemic, researchers who were testing Pfizer’s vaccine said: “speed may have come at the cost of data integrity and patient safety.”
“In autumn 2020 Pfizer’s chairman and chief executive, Albert Bourla, released an open letter to the billions of people around the world who were investing their hopes in a safe and effective covid-19 vaccine to end the pandemic. “As I’ve said before, we are operating at the speed of science,” Bourla wrote, explaining to the public when they could expect a Pfizer vaccine to be authorized in the United States,” BMJ wrote.
The Journal added, “But, for researchers who were testing Pfizer’s vaccine at several sites in Texas during that autumn, speed may have come at the cost of data integrity and patient safety.”
The allegations, according to the report, are that Ventavia Research Group “falsified data, unblinded patients, employed inadequately trained vaccinators, and was slow to follow up on adverse events reported in Pfizer’s pivotal phase III trial. Staff who conducted quality control checks were overwhelmed by the volume of problems they were finding. After repeatedly notifying Ventavia of these problems … Jackson emailed a complaint to the US Food and Drug Administration (FDA). Ventavia fired her later the same day.”
“A regional director who was employed at the research organization Ventavia Research Group has told The BMJ that the company falsified data, unblinded patients, employed inadequately trained vaccinators, and was slow to follow up on adverse events reported in Pfizer’s pivotal phase III trial.”
The former regional director, Brook Jackson told The BMJ that in her 20-year career, she’s never been fired from a job. In a recording, The BMJ states, a Ventavia executive admits to the problems alleged by Jacks, and “we know that it’s significant,” the exec says.
Jackson said she emailed her complaints to the FDA and raised some of the concerns, which include “participants placed in a hallway after injection and not being monitored by clinical staff, lack of timely follow-up of patients who experienced adverse events, protocol deviations not being reported, vaccines not being stored at proper temperatures, mislabeled laboratory specimens, and targeting of Ventavia staff for reporting these types of problems.”
Ventavia fired her later the same day after the email. The BMJ stated that Jackson has provided the Journal with dozens of internal company documents, photos, audio recordings, and emails.
Interestingly, Jackson said the FDA acknowledged her email and replied back “thanking her for her concerns and notifying her that the FDA could not comment on any investigation that might result,” and it made one call to her a few days later with little information provided.
The FDA later approved the emergency use authorization (EUA) in December 2020. However, after the FDA EUA’s approval, Jackson found that her concerns were not included in Pfizer’s application nor discussed by the FDA.
Another Ventavia employee, Jill Fisher, spoke to The BMJ and said the FDA “rarely does anything” to oversee trials, but she was surprised nothing happened in this case. She said: “You would think if there’s a specific and credible complaint that they would have to investigate that.”
Even worse, the BMJ also stated that a Department of Health and Human Services Inspector General report from 2007 showed the FDA only inspected 1% of clinical trial sites between 2000 and 2005, and it’s only gotten worse since then.
“In 2007 the Department of Health and Human Services’ Office of the Inspector General released a report on FDA’s oversight of clinical trials conducted between 2000 and 2005. The report found that the FDA inspected only 1% of clinical trial sites.6 Inspections carried out by the FDA’s vaccines and biologics branch have been decreasing in recent years, with just 50 conducted in the 2020 fiscal year,” BMW wrote.
Below are some excerpts from the report.
Worries over FDA inspection
Documents show that problems had been going on for weeks. In a list of “action items” circulated among Ventavia leaders in early August 2020, shortly after the trial began and before Jackson’s hiring, a Ventavia executive identified three site staff members with whom to “Go over e-diary issue/falsifying data, etc.” One of them was “verbally counseled for changing data and not noting late entry,” a note indicates.
At several points during the late September meeting Jackson and the Ventavia executives discussed the possibility of the FDA showing up for an inspection (box 1). “We’re going to get some kind of letter of information at least, when the FDA gets here . . . know it,” an executive stated.
A history of lax oversight
When it comes to the FDA and clinical trials, Elizabeth Woeckner, president of Citizens for Responsible Care and Research Incorporated (CIRCARE),3 says the agency’s oversight capacity is severely under-resourced. If the FDA receives a complaint about a clinical trial, she says the agency rarely has the staff available to show up and inspect. And sometimes oversight occurs too late.
In one example CIRCARE and the US consumer advocacy organization Public Citizen, along with dozens of public health experts, filed a detailed complaint in July 2018 with the FDA about a clinical trial that failed to comply with regulations for the protection of human participants.4 Nine months later, in April 2019, an FDA investigator inspected the clinical site. In May this year the FDA sent the triallist a warning letter that substantiated many of the claims in the complaints. It said, “[I]t appears that you did not adhere to the applicable statutory requirements and FDA regulations governing the conduct of clinical investigations and the protection of human subjects.”5
“There’s just a complete lack of oversight of contract research organizations and independent clinical research facilities,” says Jill Fisher, professor of social medicine at the University of North Carolina School of Medicine and author of Medical Research for Hire: The Political Economy of Pharmaceutical Clinical Trials.