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Pfizer Vaccine Trial: ‘falsified data and slow to follow up adverse events’, claims whistleblower

A whistleblower involved in Pfizer’s pivotal phase III Covid-19 vaccine trial has “blown the whistle on data integrity issues” in the pharmaceutical giant’s vaccine trial, according to an investigation published in the British Medical Journal (BMJ). The evidence reveals allegations of poor practises at Ventavia, the clinical research group hired by Pfizer as a subcontractor for the trial.

Brook Jackson, a researcher who worked as regional director at Ventavia Research Group, revealed to the BMJ that vaccine trials carried out at several sites in Texas last year had major problems – including ‘falsified data’, breaking of basic trial rules, and being ‘slow’ to report adverse reactions to the vaccine. The whistleblower says that when she notified superiors of the issues she found, she was fired from the company.

The report from investigative journalist Paul D Thacker, and published in The BMJ, states that:

“A regional director who was employed at the research organisation 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. Staff who conducted quality control checks were overwhelmed by the volume of problems they were finding. After repeatedly notifying Ventavia of these problems, the regional director, Brook Jackson, emailed a complaint to the US Food and Drug Administration (FDA). Ventavia fired her later the same day. Jackson has provided The BMJ with dozens of internal company documents, photos, audio recordings, and emails.”

The investigative report refers to an open letter published by Pzifer’s chairman and chief executive, Albert Bourla, released in autumn 2020. The letter was addressed to billions of people around the world who were investing their hopes in a safe and effective Covid-19 vaccine which would put an end to the pandemic. In the letter, Bourla wrote:  “As I’ve said before, we are operating at the speed of science,” explaining to the public when they could expect an effective Pfizer vaccine to be authorised for safe use in the United States.

 

‘DATA INTEGRITY ISSUES’

The report in the peer reviewed journal casts doubt on the way in which the trials were carried out, stating that there were issues with ‘data integrity’ owing to the speed at which the trials were conducted.

The report reads: “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. A regional director who was employed at the research organisation Ventavia Research Group has toldThe 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 revelations citing the whistleblower also state that the company fired those who complained about unethical practises to US Agency the Food and Drug Administration (FDA).

“Staff who conducted quality control checks were overwhelmed by the volume of problems they were finding. After repeatedly notifying Ventavia of these problems, the regional director, Brook Jackson, emailed a complaint to the US Food and Drug Administration (FDA). Ventavia fired her later the same day. Jackson has provided The BMJ with dozens of internal company documents, photos, audio recordings, and emails.”

 

‘POOR LABORATORY MANAGEMENT’

The investigation by The BMJ also reveals poor laboratory management. Jackson, a trained clinical auditor with over 15 years’ experience, says she repeatedly raised the issue of poor laboratory management, concerns for patient safety, and data integrity issues with her superiors. She says that after her warnings went ignored, she began documenting problems using the camera on her mobile phone.

“One photo, provided to The BMJ, showed needles discarded in a plastic biohazard bag instead of a sharps container box. Another showed vaccine packaging materials with trial participants’ identification numbers written on them left out in the open, potentially unblinding participants. Ventavia executives later questioned Jackson for taking the photos.”

Moreover, the unblinding of patients was potentially much more serious. In-line with the trial’s design,unblinded staff prepared and administered either Pfizer’s Covid-19 vaccine or a placebo. This was done to preserve the blinding of trial participants and other staff – including the principal investigator. At Ventavia, however, Jackson states that drug assignments were left in participants’ charts and visible to blinded personnel. The breach was only corrected last September, two months into the trial, at which point there were around 1,000 participants already enrolled and their data made accessible.

Jackson recorded a meeting which took place in September 2020 with two Ventavia directors. During the meeting, an executive can be heard saying that the company couldn’t quantify the types and number of errors with their testing. “In my mind, it’s something new every day,” they said, adding “We know that it’s significant.”

 

‘WORRIES OVER FDA INSPECTION’

According to the blistering report, Ventavia worried about the possibility of the FDA showing up for an inspection of the trial

“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. “We’re going to get some kind of letter of information at least, when the FDA gets here . . . know it,” an executive stated.”

 

CONCERNS RAISED BY JACKSON TO THE FDA:

On the morning of 25 September 2020, Jackson called the FDA to warn about unsound practises in Pfizer’s pivotal clinical trial at Ventavia. She then reported her concerns in an email to the agency. That same afternoon, Ventavia fired Jackson from her job – deeming her “not a good fit,” according to her separation letter.

Jackson told The BMJ it was the first time she had been fired in her career in research which had spanned 20 years.

In the email sent on 25 September, she wrote that Ventavia had enrolled over 1,000 participants at three sites, out of the full trial’s 44,000 participants across 153 sites which included various academic institutions and commercial companies. She raised concerns over issues she had witnessed, including:

  • 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
  • Mislabelled laboratory specimens, and
  • Targeting of Ventavia staff for reporting these types of problems.Hours later, she received an email back from the FDA, thanking her for her input but notifying her that they would not comment on any subsequent investigation. Having said that, in August of this year, the FDA published a summary of its inspections of Pfizer’s phase III trial.

They observed just nine out of the trial’s 153 sites, and did not look at any of Ventavia’s operations. Further, no inspections were carried out following the December 2020 emergency authorization of the vaccine.

 

OTHER EMPLOYEES VALIDATED JACKSON’S CONCERNS

In recent months Jackson has communicated with several former Ventavia employees who all left or were fired from the company, with one of them being one of the officials who had taken part in the late September meeting. In a text message sent in June the former official apologised according to Jackson, saying that“everything that you complained about was spot on.”

Two former Ventavia employees, including the one mentioned above, spoke with The BMJ anonymously “for fear of reprisal and loss of job prospects in the tightly knit research community”. Both confirmed “broad aspects” of Jackson’s account.

“I’ve never had to do what they were asking me to do, ever,” she told The BMJ. “It just seemed like something a little different from normal—the things that were allowed and expected.”

Meanwhile, the second employee told The BMJ that working at Ventavia was unlike any environment she had experienced in 20 years of research. She said she had never experienced such a “helter skelter” work environment as with Ventavia on Pfizer’s trial.”

She also said that during her time at Ventavia the company expected a federal audit but that this never happened. After Jackson was removed from the company, other problems reportedly persisted at Ventavia, according to the employee.

In several cases it is reported that Ventavia lacked enough employees to swab all trial participants who reported covid-like symptoms, to test for infection. Laboratory confirmed symptomatic covid-19 was the trial’s primary endpoint, the employee noted. (An FDA review memorandum released in August this year states that across the full trial swabs were not taken from 477 people with suspected cases of symptomatic covid-19.)

According to The BMJ report, one employee labelled the data generated for the Pfizer trial as “a crazy mess”: “I don’t think it was good clean data,” the employee said of the data Ventavia generated for the Pfizer trial. “It’s a crazy mess.”

Meanwhile, since the whistleblower reported the issues with Ventavia to the FDA back in September 2020, Pfizer has hired Ventavia as a research subcontractor on four other clinical trials, according to The BMJ report (Covid-19 vaccine in children and young adults, pregnant women, and a booster dose, as well as an RSV vaccine trial).

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