Paul Thacker, a former investigator for the U.S. Senate Finance Committee specializing in corruption in science and medicine, has written a blockbuster expose questioning the integrity of some the Pfizer trials on which the FDA’s emergency approval for the company’s Covid vaccine was based. A former regional director involved in some of the pivotal phase III trials told Thacker that her company, Ventavia Research Group, falsified data, unblinded patients, employed inadequately trained vaccinators, and was slow to follow up on adverse events.

The regional director, Brook Jackson, emailed the FDA alerting the agency the trial’s data was compromised, but the agency still granted emergency approval nearly three months later. Ventavia fired Jackson hours after she alerted the FDA.  

What is especially alarming is that Thacker in July of last year published this article in The Daily Beast headlined, The Sketchy Past of Trump’s Coronavirus Vaccine Czar. It was a profile of Moncef Slaoui, who oversaw Operation Warp Speed, the accelerated program to bring a Covid vaccine to market. Slaoui, a molecular biologist and immunologist and the former chairman of vaccines at GlaxoSmithKline, previously downplayed reported risks associated with GSK’s diabetes drug Avandia.

“I know this, because I was the U.S. Senate Finance Committee’s lead investigator on the bipartisan investigation of GSK and Avandia, and our reports found that GSK had bullied critics of the drug, hid data, and misled the public,” Thacker wrote.

“By testifying before Congress and the American public that the drug was fine and by working with his colleagues to undermine a study that found it was dangerous, Slaoui assisted GSK’s strategy to deny the drug’s dangers, which ultimately led to a $3 billion federal fine to settle criminal and civil liability related to several of the company’s drugs, including Avandia. The month after Slaoui testified, FDA scientists presented an analysis estimating that Avandia had caused approximately 83,000 excess heart attacks in America since coming on the market.”

GSK’s $3 billion fine in 2012 was the largest U.S. fine ever paid by a pharmaceutical company. The previous record was the $2.3 billion Pfizer paid in 2009 for fraudulent marketing.

The allegations in Thacker’s expose are damning but must be taken seriously given that it appears in The BMJ, a peer-reviewed medical journal published by the British Medical Association. Underscoring the quality of BMJ’s editorial staff, Elizabeth Loder, the publication’s head of research, holds administrative and clinical positions at Brigham and Women’s Hospital in Boston and is a professor at Harvard Medical School.

BMJ is hardly an antivaxxer publication. It’s home page currently includes this commentary arguing that vaccination should be mandatory for all healthcare workers.

Among the allegations that Jackson, a clinical trial auditor with more than 15 years of experience, reported to the FDA about the Pfizer trials she was involved in:

Vaccine trial participants were placed in a hallway after injection and were not monitored by clinical staff;

Lack of timely follow-up of patients who experienced adverse events;

Protocol deviations weren’t reported;

Vaccines weren’t stored at proper temperatures;

Laboratory specimens were mislabeled;

Clinical trial staff who reported issues were targeted.

According to Thacker’s report, Jackson received an email from the FDA “within hours” acknowledging her email. An FDA inspector followed up with Jackson “a few days later” but she heard nothing further from the agency after that.

Thacker quotes another former Ventavia employee, who previously worked on more than four dozen clinical trials, including many large trials, saying, “I’ve never had to do what (Ventavia) asked me to do, ever.” The employee, who insisted on not being identified for fear of reprisal and loss of job prospects, said, “It just seemed like something a little different from normal – the things that were allowed and expected.”

In several case, the unidentified employee said, Ventavia lacked enough employees to swab all trial participants who reported Covid-like symptoms, to test for infection. Thacker reports that an FDA review memorandum released in August stated that across the full trial swabs were not taken from 477 people with suspected cases of symptomatic Covid-19.

Another peculiarity I’ve discovered is the FDA’s dismissal of ivermectin, an anti-parasite drug it has gone to great lengths to dismiss as an animal drug because it comes in veterinary formulations. “You are not a horse. You are not a cow. Seriously y’all. Stop it,” the agency tweeted August 21 urging people not to use ivermectin to treat Covid.

Yet ivermectin appears on a list the FDA issued on July 8 of drugs approved or under evaluation to treat Covid.

FDA critics say the agency is too close, and too trusting, of Big Pharma. One possible reason is that pharmaceutical companies underwrite three-fourths of the FDA’s budget for drug reviews.

Although the corporate media often reports the FDA is too slow to approve drugs, nonprofit ProPublica in 2018 reported that FDA reviews and approves drugs faster than any other regulatory agency in the world. Between 2011 and 2015, the FDA reviewed new drug applications in more than 60 days faster on average than did the European Medicines Agency.

FDA employees often leave the agency for lucrative Big Pharma jobs, including staffers who oversaw reviews of drugs developed by the companies they joined. Scott Gottlieb, a former FDA commissioner during the Trump Administration, sits on Pfizer’s board.

Thacker’s BMJ’s expose is worthy of scrutiny. My guess is the corporate media will ignore it and social media will censor mentions of it, including this post.  LinkedIn has censored my posts multiple times.

It’s among the hazards of daring to speak truth to power.

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