BMJ Report Reveals Numerous Irregularities in Pfizer’s Trial of its COVID-19 Vaccine
Originally published on Medium 14 November 2021
A whistleblower has revealed numerous irregularities at one of the contract research centers charged with testing the Pfizer COVID-19 vaccine, according to a 2 November report in the BMJ.
The whistleblower, Brook Jackson, is a trained clinical trial auditor with fifteen years’ experience in clinical research coordination and management. During the two weeks she was employed by Ventavia Research Group in Texas, she observed numerous safety and protocol violations, including the following:
· Needles discarded in a plastic biohazard bag instead of instead of a sharps box
· Vaccine packaging materials with trial participants’ identification numbers written on them left in the open, potentially unblinding the participants
· Drug assignment conformation printouts left in participants’ medical charts, potentially unblinding clinicians
· Participants placed in hallways after injections and not monitored by clinical staff (a rare but potentially lethal complication of being injected with any vaccine is syncope or fainting, which on rare occasions has led to fatal head injury)
· Lack of timely follow-up on patients who experienced adverse events
· Protocol deviations not reported
· Mislabeled laboratory specimens
· Lack of enough employees to swab all participants with “covid-like symptoms” to detect presence of symptomatic COVID-19, the trial’s primary endpoint
· Retaliation against staff members who reported problems
After repeatedly notifying her superiors of these problems, Jackson took her concerns to the FDA and was fired the same day. She said this was the only time she had been fired during her twenty-year career in research. Jackson has provided the BMJ with photos, company documents, audio recordings, and emails to back up her claims.
The BMJ interviewed other former Ventavia employees as well, who corroborated many of Jackson’s claims. One said she had worked on over four dozen clinical trials but had never encountered such a “helter-skelter” environment as she found at Ventavia.
All this raises the larger question: who’s minding the store? According the BMJ article, only nine of the trial’s 153 sites were inspected by the FDA. Ventavia was not among them.
Pfizer’s ability to police its own behavior, let alone that of all its CRO’s, is open to question. In 2009, the company paid out $2.3 billion to settle claims of illegal marketing of its nostrums, including Bextra, Geodon, Zyvox, and Lyrica. This was the largest such settlement in history at the time, although this record has since been surpassed by the $3 billion paid out in 2012 by fellow industry behemoth GlaxoSmithKline.
Two years later, Pfizer reached a settlement regarding its 1996 trial of the experimental antibiotic trovafloxacin during a deadly epidemic of meningitis in Kano, Nigeria. The plaintiffs’ lawyers alleged that Pfizer had given children enrolled in the control arm only one third-of the recommended dose of the comparator drug, ceftriaxone, and that the company failed to inform families that their children were enrolled in an experimental drug trial and that free effective treatment was available at the same hospital. Pfizer agreed to pay out $175,000 to each of four families whose children had died while enrolled in the trial.
In June of 2014, Pfizer agreed to pay out $325 million to settle claims of illegal marketing of its drug Neurontin, and by August of that same year, they had paid out $491 million to settle claims of illegal marketing of Rapamune.
Lead Stories, which bills itself as “A fact checking website that is always looking for the latest false, deceptive, or inaccurate stories (or media) making the rounds on the internet” purported to fact-check the BMJ story, warning readers “On Twitter, [Brook] Jackson does not express unreserved support for COVID vaccines” while assuring them that “Pfizer said it has reviewed the claims and found them to be unproven.” Given Pfizer’s track record at the sort of thing, that’s cold comfort.