Ventavia Research Group

Ventavia Research Group LLC is an American clinical trial company based in Texas.

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On its website Ventavia calls itself the largest privately owned clinical research company in Texas and lists many awards it has won for its contract work.2 But Jackson has told The BMJ that, during the two weeks she was employed at Ventavia in September 2020, she repeatedly informed her superiors of poor laboratory management, patient safety concerns, and data integrity issues. Jackson was a trained clinical trial auditor who previously held a director of operations position and came to Ventavia with more than 15 years’ experience in clinical research coordination and management.

Exasperated that Ventavia was not dealing with the problems, Jackson documented several matters late one night, taking photos 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.

https://www.bmj.com/content/375/bmj.n2635

Pfizer Vaccine Trial Controversy

Covid-19: Researcher blows the whistle on data integrity issues in Pfizer’s vaccine trial BMJ 2021;375:n2635; https://www.bmj.com/content/375/bmj.n2635

Complaint

Text of complaint

To Whom It May Concern:

Pursuant to the Freedom of Information Act, I hereby request the following:

Any documents, files, or records from the Food and Drug Administration's Center for Biologics Evaluation and Research, or CBER, that may show the receipt of a complaint in September 2020 related to Ventavia Research Group's work on Pfizer's Phase III trial for the COVID-19 vaccine. I would like a copy of the complaint, recognizing that all personal identifying information should be redacted, as well as any documents, files, or records dealing with the complaint that may indicate how FDA's CBER handled the complaint. This includes whether there was a follow-up by any CBER employees or if CBER employees closed or dismissed the complaint.

If the complaint was not initially submitted to CBER, please search your records to find out if it was eventually transferred from another part of the FDA to CBER for proper consideration.

According to an article by Paul Thacker published at the British Medical Journal's (BMJ) website, “Covid-19: Researcher blows the whistle on data integrity issues in Pfizer’s vaccine trial,” the complaint that is a subject of this request was submitted by Brook Jackson, who was a regional director for Ventavia Research Group, which has been subcontracted by Pfizer for multiple vaccine clinical trials.

Jackson claims to have observed an array of issues that relate to the methodical and ethical integrity of Ventavia's work at three trial sites. Jackson maintains Ventavia was notified of problems but took no action. Jackson emailed a complaint to the FDA. (Note: The BMJ article was published on November 2, 2021, and accessed on November 12, 2021.)

The article published at the BMJ received coverage from The Conversation, Medpage Today, and CBS17, a local news affiliate in North Carolina. All three outlets sought to fact-check or assess the validity of the claims from someone who purported to be a whistleblower. It also was widely discussed on YouTube and social media, fueling the urge by press to fact-check or assess the seriousness of the allegations in order to tamp down any unnecessary panic.

I acknowledge it is not stated in the article if Jackson submitted the complaint to any particular division, but based on the responsibilities of CBER, it seems likely that employees in this division eventually handled or reviewed the reported complaint.

My weekly newsletter, The Dissenter, covers whistleblower stories, hence my interest in seeking these records. It is a project of Shadowproof, a membership-funded and reader-funded media organization established in 2015.

As a professional reporter who has a track record of coverage of whistleblower, I assert that I should be designated as a media requester for the purpose of assessing fees. Given the amount of public interest in the safety of COVID-19 vaccine clinical trials, and FDA oversight of such trials, I additionally ask that any and all fees be waived. In the event that there are fees, I would be grateful if you would inform me of any and all charges in advance of fulfilling my request.

In the event that there are fees, I would be grateful if you would inform me of the total charges in advance of fulfilling my request. I would prefer the request be filled electronically, by e-mail attachment if available.

Thank you in advance for your anticipated cooperation in this matter. I look forward to receiving your response to this request within 20 business days, as required by the statute.

Sincerely,

Kevin Gosztola

Ventavia Hired for Future Pfizer Clinical Trials

Study to Evaluate the Safety and Efficacy of a Booster Dose of BNT162b2 Against COVID-19 in Participants ≥16 Years of Age https://clinicaltrials.gov/ct2/show/NCT04955626

A Phase 1/2/3 Study to Evaluate the Safety, Tolerability, and Immunogenicity of an RNA Vaccine Candidate Against COVID-19 in Healthy Children and Young Adults https://clinicaltrials.gov/ct2/show/NCT04816643

Study to Evaluate the Safety, Tolerability, and Immunogenicity of SARS CoV-2 RNA Vaccine Candidate (BNT162b2) Against COVID-19 in Healthy Pregnant Women 18 Years of Age and Older https://clinicaltrials.gov/ct2/show/NCT04754594

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