And here we go again – a so-called COVID-19 vaccine whistleblower makes vague claims about the Pfizer clinical trials. Predictably, the anti-vaccine world points a trembling, HPV-riddled finger at us, screaming “SHAME. SHAME. SHAME.”
Except, like a lot of these stories, the anti-vaxxers overstate anything critical about the COVID-19 vaccines, while ignoring the vast majority of evidence that support the overwhelming safety and effectiveness of these vaccines. Their confirmation bias is amazing.
Anyway, let’s take a look at this COVID-19 vaccine whistleblower and see if anything they say passes the smell test.
All about clinical research organizations
Before I discuss the veracity of her complaints, let’s first describe how the clinical trial system works. Even though Pfizer is the sponsoring company of the clinical trial, most pharmaceutical companies do not actually run the phase 2 or phase 3 clinical trials (most will run their own phase 1 trial, but not always).
Usually, pharmaceutical companies contract with Contract Research Organizations (CRO) to manage the clinical trial. CROs provide support to the pharmaceutical, biotechnology, and medical device industries in the form of research services. A CRO can provide a wide range of services as biopharmaceutical development, biologic assay development, commercialization, preclinical research, clinical research, clinical trials management, and pharmacovigilance.
CROs monitor all aspects of the clinical trial. In the case of vaccines, they will recruit patients, test the patient for the presence or absence of the targeted disease, examine the patients for health issues that may exclude them from the trial, deliver the vaccine, and then monitor the subjects afterward. They keep detailed records on each subject that is then sent to the pharmaceutical company for statistical analyses.
The CROs usually subcontract to other companies or organizations to perform the actual work, including getting data in clinical trials. Sometimes, these subcontractors are physician-scientists at a particular research institution, or, in the case of large phase 3 clinical trials such as Pfizer’s COVID-19 clinical trials, they are smaller clinical research companies. Ventavia is one of those.
Twenty years ago, pharmaceutical companies managed all aspects of the clinical trial. But as companies were managing more and more clinical trials, it seemed like a good idea to contract with CROs, which had the added benefit of removing some bias that might arise if the pharmaceutical company was managing the clinical trial directly.
Furthermore, small biotech companies rarely have the resources to manage a clinical trial so they have always used CROs.
The system works well – the CROs are well managed and they closely follow clinical trial protocols and all protect their ethical reputations. But as the CRO industry grew, they could no longer handle all of the actual patient interactions, so that’s when CROs began subcontracting smaller companies that would be responsible for patients in one area – for Ventavia, it was Texas.
Although there are some horror stories about bad actors in this subcontract CRO industry, the primary CROs monitor them extremely closely and weed out unethical or incompetent firms. And once these subcontractors mess up, it becomes known to the CRO, the pharmaceutical companies, and the FDA. And their business promptly dries up.
Of course, the drive to make money, since CROs are paid for recruiting and monitoring patients they could be tempted to falsify records. But there are numerous checks, including random inspections and triple blinding where even the CRO is unaware of which patient got which drug or vaccine and which got the placebo.
What did the COVID-19 vaccine whistleblower have to say?
In an article published on 2 November 2021, The BMJ reported that Texas clinical trial contractor Ventavia Research Group unblinded patients in the Pfizer phase III vaccine trial. The results were part of the data that led to the vaccine’s approval. The article also claimed that Ventavia used inadequately trained “vaccinators” to deliver the vaccine and placebo to patients.
The employee, Brook Jackson, who worked as a regional director for Ventavia, is said to have reported her concerns to the FDA. Jackson claimed that Ventavia was selected to speed up Pfizer’s COVID-19 vaccine trial.
The BMJ wrote:
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 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 full trial (registered under NCT04368728) enrolled around 44,000 participants across 153 sites that included numerous commercial companies and academic centers. Ventavia was only one of those 153 sites, so keep that in mind.
Jackson listed a dozen concerns 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.
- Discarded needles in regular waste instead of a sharps container
All of this sounds extremely serious. Except for a few major issues:
- None of those issues that Jackson mentioned seemed very serious or have an impact on data integrity. They are minor ones that are described in the most general terms and have little impact on the safety and effectiveness of the trial.
- One of the issues that Jackson complained about was where sharps were disposed. That is not an indicator of the quality of the clinical trial, but some minor training issue.
- In fact, they seem to be very fuzzy and imprecise – it appears to be nothing more than someone angry about getting terminated rather than someone who has seen something unethical.
- Again, this is just one of the 153 sites that performed thse clinical trials. And, to claim that it happened at the other 152 sites is ridiculous on so many levels. Unless you want to fall for the stereotyping fallacy.
- The FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC), whose members are indepedent vaccine scientists and public health experts, reviewed the data from all 153 sites and found them credible. These are real scientists, not some journalist at The BMJ, which is starting to take an anti-vaccine stance, who reviewed the data.
According to Paul Offit, MD,
It’s all this sort of vague kind of hand waving; I have no idea whether any of this is true, nor do you. That The BMJ published it doesn’t make it any more true. If this whistleblower believes that they have a whistle to blow, then blow it. And then let’s have the company respond.
Not a single thing that Jackson complained about seemed to have any impact on data collection. They all seem to be minor issues that the whistleblower and The BMJ seem to think is an indicator of something rotten in the state of the Pfizer COVID-19 vaccine.
Usually, whistleblowers bring a treasure trove of documents to support their claims. Yet, The BMJ and Jackson showed us nothing. And I still stand by my statement above that even with supporting documentation, none of this seems to be very important.
Furthermore, Ventavia has been forthcoming to the FDA, responding to requests from them.
But the worst part of this story is that author of the article, Paul Thacker, made no attempt to contact either Pfizer, who is ultimately responsible for all of the data and Ventavia to explain what had happened. Is that responsible investigative journalism? I don’t think so.
If Thacker had found something serious, like falsified data, in 10 or 20 research sites, I’d be terribly concerned, especially if it were supported by documents. But sharps not being placed in a sharps container? Really? That’s an OSHA problem, not an FDA one.
I don’t know why The BMJ and Paul Thacker thought this was some gotcha moment about the Pfizer clinical trial. Maybe it was a vain attempt to impugn the integrity of the Pfizer COVID-19 clinical trial with a “whistleblower” claim to harm vaccine uptake. Maybe it’s lazy journalism.
I don’t know and I don’t care. These were unimportant and irrelevant whistleblower claims that showed me nothing about the integrity of the data used by the FDA and VRBPAC to authorize the use of the Pfizer COVID-19 vaccine.
Unfortunately, the anti-vaxxers will now scream “SHAME, SHAME, SHAME.”
