Credit: Stefan Amer / Scopio

British Medical Journal: Experts say Covid-19 vaccine trials oversight “grossly inadequate”

Developed at "warp speed"

An investigation for the British Medical Journal (BMJ) says that “covid-19 vaccines and drugs were developed at “warp speed” and now experts are concerned that the US Food and Drug Administration inspected too few clinical trial sites.”

The public and scientific journals were not notified when violations at the clinical trials for the Covid-19 vaccines were identified, “effectively keeping scientific misconduct from the medical establishment” according to experts.

One senior FDA adviser said the lack of disclosure was “endangering public health”.

The investigation by Maryanne Demasi for one of the most prestigious peer-reviewed journals, found that only 9 out 153 Pfizer trials sites were subject to FDA inspection before licensing the mRNA vaccine.

“Similarly, only 10 out of 99 Moderna trial sites and five of 73 remdesivir trial sites were inspected,” Ms Demasi found.

“Now, facing a backlog of site inspections, experts have criticised the FDA’s oversight of clinical trials, describing it as “grossly inadequate.” They say the problem, which predated covid-19, is not limited to a lack of inspections but also includes failing to notify the public or scientific journals when violations are identified—effectively keeping scientific misconduct from the medical establishment,” she wrote.

She recounts how, in September 2020, the US Food and Drug Administration (FDA) “received a complaint by Brook Jackson who had been working for Ventavia Research Group, a Texas based company hired to run clinical trials for Pfizer’s covid-19 mRNA vaccine.”

“Jackson, a regional director, had witnessed problems at three trial sites she was overseeing and complained to an FDA inspector about a range of problems including falsified data, unblinded patients, and inadequately trained vaccinators who were slow to follow up on adverse events. “I thought that the FDA was going to swoop in and take care of everything. What I was reporting was so important,” Jackson told The BMJ. The FDA did not, however, inspect the trial sites in question.”

But the BMJ says the lack of oversight “was not an isolated case”. Their investigation points to the regulatory documents that show just a fraction of the clinical trial sites were inspected by the FDA before licensing the mRNA vaccine against Covid-19.

Just 9 out 153 Pfizer trial sites were FDA inspected – less than 6% of the total. Similarly, only 10 out of 99 Moderna trial sites – only 10% of the sites – and five of 73 remdesivir trial sites – or 7% of the total –  were inspected by the regulatory body.

One expert said that the FDA is “endangering public health” by not being forthcoming about violations uncovered during the inspections that did take place.

David Gortler, a pharmacist and pharmacologist who worked as an FDA medical reviewer for four years to 2011 and who was then appointed as a senior adviser to the FDA commissioner in 2019-21, told the BMJ that the FDA should have been ramping up its inspections at the peak of the Covid crisis – but that instead they were “scaled back”.

“The lack of full transparency and data sharing does not allow physicians and other medical scientists to confirm the data independently and make comprehensive risk-benefit assessments,” Gortler told the BMJ.

“Between March and July 2020, at the peak of pandemic restrictions, the FDA paused its site inspections and only “mission critical” inspections were carried out. Gortler says, however, that this was the time that the FDA should have ramped up its oversight, not scaled back, especially since covid-19 products were being developed at warp speed and intended for millions of people. “The drug companies took appropriate measures to keep staff safe, which is exactly what the FDA could and should have done,” he said.

The investigation uncovered that a former staffer in the FDA’s Office of Criminal Investigations had written that: “Having worked at the FDA, I see it as surprising, for many reasons, that the agency turned a blind eye . . . They likely feared the criticism they undoubtedly would have received for holding up a vaccine (which they knew they would eventually approve anyway) at the expense of untold lives lost.”

The former FDA employee, who signed a non-disclosure agreement, added: “My point here is that instead of the regulators protecting the public, they were complicit. At the time, they may have been doing what they believed to be the right thing under extraordinary circumstances. But now, they may soon have some explaining to do.”

In response to the BMJ investigation the FDA said that Covid restrictions meant some reliance on “remote regulatory assessments”, including the use of ‘virtual inspections using live streaming and video conferencing and requests to view records remotely.’

But Gortler “laughed at the proposition”, the BMJ reported.

“You can’t do a remote inspection. That’s like saying I’m going to arrest somebody remotely. You have to be there on site and look at every nuance such as cleanliness, organisation, staff coordination—even their body language. During a pandemic, the FDA could’ve put inspectors in hazmat suits if they wanted to, there’s no excuse for not going onsite.”

Ms Demasi said that the FDA has “a long history of failing adequately to oversee clinical trial sites” and cited previous criticisms of audits and inspections.

She notes that: “the FDA does not typically notify journals when a site participating in a published clinical trial receives a serious warning, or alert the public about the research misconduct it finds” – a practice that Gortler finds “unconscionable”.

“Misconduct should be released immediately. It’s malpractice not to; it’s irresponsible,” he says.

Read more of the investigation here: https://www.bmj.com/content/379/bmj.o2628

The European Medicines Agency says the authorised COVID-19 vaccines are “safe and effective” and that they “were evaluated in tens of thousands of participants in clinical trials and have met EMA’s scientific standards for safety, efficacy and quality.”

 

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