Perfunctory²

Passing along The BMJ's Pfizer trial bombshell.

“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.”¹

A report appearing in The BMJ details the chaos, incompetence, and suppression of dissent that reigned during the perfunctory American show-trial conducted for the Pfizer/BioNTech Covid vaccines.

The report is derived from insider testimony by employees of Ventavia, a company contracted by Pfizer to implement their protocol in Texas (from my reading of the report, it is not clear if Ventavia was responsible for the entirety of the Pfizer trial in America, but they seem to have been a major participant at least - Edit, November 10: I obviously missed the relevant text in report: Ventavia was responsible for 1,000 out of 44,000 total participants).

source: bmj.com

Due to some quirk of my selection of who to follow in “Covid vax skeptical world,” I haven’t seen The BMJ’s report making the rounds. So, I am posting this short, perfunctory bulletin for any subscribers who haven’t already encountered it via twitter, comment threads etc.

I recommend reading and sharing the report itself. The scale of folly detailed within is not really condensable, even if it is only a partial glimpse of the magnitude of errors and oversights Ventavia committed in their preparation of the data Pfizer later massaged to construct their official results. Here, however, are a few highlights (emphasis added):

• In a recording of a meeting in late September2020 between Jackson and two directors a Ventavia executive can be heard explaining that the company wasn’t able to quantify the types and number of errors they were finding when examining the trial paperwork for quality control. “In my mind, it’s something new every day,” a Ventavia executive says. “We know that it’s significant.”

• Ventavia was not keeping up with data entry queries, shows an email sent by ICON, the contract research organisation with which Pfizer partnered on the trial. ICON reminded Ventavia in a September 2020 email: “The expectation for this study is that all queries are addressed within 24hrs.” ICON then highlighted over 100 outstanding queries older than three days in yellow. Examples included two individuals for which “Subject has reported with Severe symptoms/reactions […]

• Early and inadvertent unblinding may have occurred on a far wider scale.[…] As a corrective action taken in September, two months into trial recruitment and with around 1000 participants already enrolled, quality assurance checklists were updated with instructions for staff to remove drug assignments from charts [as should have been done from the beginning].

• The next morning, 25 September 2020, Jackson called the FDA to warn about unsound practices in Pfizer’s clinical trial at Ventavia. She then reported her concerns in an email to the agency. In the afternoon Ventavia fired Jackson—deemed “not a good fit,” according to her separation letter.

• Two former Ventavia employees spoke to 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 complaint. One said that she had worked on over four dozen clinical trials in her career, including many large trials, but had never experienced such a “helter skelter” work environment as with Ventavia on Pfizer’s trial. […] She added that during her time at Ventavia the company expected a federal audit but that this never came.

• In several cases 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.)

• Since Jackson reported problems with Ventavia to the FDA in September 2020, Pfizer has hired Ventavia as a research subcontractor on four other vaccine clinical trials (covid-19 vaccine in children and young adults, pregnant women, and a booster dose […]

• Competing interests: [Paul Thacker, the author] has been doubly vaccinated with Pfizer’s vaccine.²

In Pflain Sight

Much, if not all of this was already inferable from the trial protocol itself, which was both overambitious in breadth and barebones-to-the-point-of-absurdity in depth to begin with.

Despite being a behemoth of templated, legalistic procedural logic, the amount of times the protocol calls for participants to be touched by the trial in any form, absent a volunteered adverse event, are few, and the spectrum of diagnostics taken from them by default are super-anemic. For the handful of selected “sentinel” Phase I participants, follow-up events are increased to 10; blood sample collection nonetheless stops at one week after the second dose.³ Blood samples are sent to labs for tests that focus on nothing in particular, besides a bit of screening for kidney or liver damage.⁴

For other Phase I and all Phase II/III participants, visits are reduced to 7 and 6 respectively, and blood samples are only used to monitor antibody responses to the injection.⁵ “Physical exams” are only conducted before the first dose; participants are directly observed for a mere 30 minutes after each injection; and two corresponding 7-day “diaries” are provided for later review - complete with thermometers for taking temperature and a vaguely-defined “measuring device” to track redness or swelling at the injection site.⁶

It did not require a contractor whistleblower, in other words, to demonstrate that Pfizer was never genuinely engaged in assessing whether the vaccines worked or were safe. The protocol was a sufficient confession. Certain edits refer to changes in the mRNA candidate script that imply BioNTech was leading the product evaluation process.⁷ The trial design indicates that not a single thought was given to screening for novel toxicities as could be expected with a novel platform - nor that even a fragment of Pfizer’s multi-billion dollar budget would be devoted to the operation of the trial in the first place. With so much ink spilled to describe so few participant interactions, the trial protocol document requires almost as much labor to write and read as to operate.

It did not require a whistleblower, either, to demonstrate that the results Pfizer presented to the FDA did not provide an accurate account of adverse events. Here, the appearance of 12 year-old Maddie de Garay, in Pfizer’s submission to the FDA, as a case of “functional abdominal pain,” suffices as a case-study in their willingness to obscure the already poorly-recorded harms of the foreign product they have been charged with marketing to the American public. De Garay has been through hell as a result of her parent’s trust in the experimental drug administered to her by the trial.⁸

Still, for outsiders, it can be difficult to assign certainty to these strong indications of Pfizer’s disengagement and malfeasance. The BMJ report, which breaks the closed-ranks that medicine and journalism have formed in support of the Covid vaccines, backs up impression with detail.

1. Thacker, Paul. “Covid-19: Researcher blows the whistle on data integrity issues in Pfizer’s vaccine trial.” (2021, November 2.) The BMJ.

2. ibid.

3. See: https://www.nejm.org/doi/full/10.1056/nejmoa2034577#article_supplementary_material (pdf), page 16 and 17.

The protocol is difficult to read. If I have represented it over-simplistically, I hopefully have done so in the direction of overstating the depth of actual diagnostics. These screenshots and descriptions apply to the original final draft; further amendments tended to streamline the program, especially via the removal of the intermediary II cohort (see below).

4. The listed tests are hemoglobin, complete blood count with differential, and platelets, alanine aminotransferase, aspartate aminotransferase, alkaline phosphate, total bilirubin, blood urea nitrogen, creatinine.

5. Seven visits were initially planned for II:

Visits were to then be reduced to 6 in stage III. The July 24 revision, which removed a separate schedule for II and created “Phase II/III,” used a lightly edited “III” schedule for the new supergroup:

6. Presumably some form of paint swatch:

7. See pages 6 - 8 of the October revision.

8. See Siri, Aaron. “FDA Buries Data on Seriously Injured Child in Pfizer’s Covid-19 Clinical Trial.” (2021, October 22.) Injecting Freedom.

See also, Stephanie and Maddie de Gray’s testimony at 2:28:40 of Senator Ron Johnson’s November 1 Expert Panel on Federal Vaccine Mandates. The relevant slide:

De Garay explains the trial process from the participant perspective - including having no ability to directly register reactions which extend beyond the 7 day window or do not match the obviously mild solicited events in the provided diary. Maddie’s reaction could only be relayed to eventual lead author Frank over the phone. For more, see “And a Waste of Time.”