Senior editor of British Medical Journal voices concerns to FDA over integrity of Pfizer trial data

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May 10, 2022 | 

Dr. Peter Doshi, a man with a number of respected credentials in the medical field, has expressed some concerns about the integrity of data used in Pfizer’s vaccine trials.

The news was reported in the Naked Emperor’s Newsletter Substack post which discussed an April 6 meeting of the Food and Drug Administration’s Vaccines and Related Biological Products Advisory Committee. During the meeting’s Open Public Hearing Session, where members of the public can provide their own findings and information to the FDA, Dr. Doshi called in to present his own results.

Doshi has a respected reputation in the medical field, is an associate professor of pharmaceutical health at the University of Maryland School of Pharmacy, and is a senior editor at the prestigious British Medical Journal.

According to his faculty page at the University of Maryland, Doshi’s “research focuses on the drug approval process, how the risks and benefits of medical products are communicated, and improving the credibility and accuracy of evidence synthesis and biomedical publications.”

In other words, Doshi isn’t just some kook who called in for yucks—he is a distinguished scientist with a great deal of institutional credibility.

So it’s important to listen when Dr. Doshi spoke to the FDA about the case of Brook Jackson, a whistle-blower from the privately-owned clinical research company Ventavia, which oversaw Pfizer’s vaccine trials. Jackson’s testimony indicated the “unblinding” of trial participants.

Blinding in pharmaceutical and medical trials is designed to eliminate the bias of expectation, which could influence the research findings in the trial. Unblinding, therefore, calls into question the accuracy of any trials in which this may have occurred.

Doshi explained the situation in his comments to the FDA.

“Last November,” he said, “The BMJ [British Medical Journal] reported the disclosures of a whistle-blower named Brook Jackson, who worked for Ventavia, a contract research company that ran three of the clinical trial sites for Pfizer’s vaccine. Jackson alleged the company had falsified data, unblinded patients, employed inadequately trained vaccinators, and was slow to follow up on adverse events. She provided The BMJ with company emails, internal documents, text messages, photos and recordings of her conversations with company employees.”

During his presentation, Doshi provided photographs that allegedly corroborated Jackson’s claims, including pictures of vaccine packaging materials lying around that clearly indicate who the manufacturer was, and which should only have been seen by “unblinded” staff. Doshi also indicated that the unblinding existed on a large scale during the trials.

“Unblinding,” Doshi continued, “as I think everybody knows, creates serious concerns about data integrity…In the heat of a pandemic, it’s not hard to imagine that corners were cut and mistakes were made. Some mistakes are benign, but others carry serious consequences to data integrity. One hopes Ventavia is an extreme outlier, but we need more than just hope. We need evidence that the data were dealt with properly. We need regulatory oversight.”

“Trustworthy science requires data transparency,” he added. “It’s been over a year, but anonymized participant-level data remain inaccessible to doctors, researchers, and the public. The public paid for these products, and the public takes on the balance of benefits and harms post-vaccination. The public has a right to data transparency, and FDA has an obligation to act. Thank you.”

Amidst the scientific jargon and technical terminology, it’s clear that Doshi is raising concerns about the objectivity of the trials used to determine the efficacy of Pfizer’s vaccine. And it’s not Pfizer alone—Doshi also mentions Moderna, claiming that the FDA only inspected one of the company’s 99 trial sites after more than a year.

 You can watch Dr. Doshi’s presentation in the video below, which begins at the 5:34 mark. 






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