US officials failed to oversee the vast majority of trial sites for Covid vaccines properly, according to a scathing new report.
The Food and Drug Administration, which is charged with inspecting facilities where clinical trials of drugs and vaccines take place, inspected just 5 per cent of Pfizer vaccine trial sites, 10 per cent of Moderna sites, and 7 per cent of remdesivir sites.
It remains unclear whether the rest of inspections were conducted virtually using live streaming and video conferencing and requests to view records remotely, or if they were even inspected at all.
The findings were published Wednesday in the prestigious British Medical Journal (BMJ).
Dr David Gortler, a fellow at the conservative Ethics and Public Policy Center, said ‘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, organization, staff coordination—even their body language.’
The investigation came on the back of a whistleblower claim that one trial site in Texas had skewed data, didn’t investigate side effects and failed to test people.
The FDA did not confirm whether it followed up on the concerns with an inspection.
Globally, more than 12.7 billion shots have gone into arms. Over 613 million shots have been given in the US since the first Covid-19 vaccine was authorized by the FDA in December 2020.
Since then, the scientific community has amassed a mountain of real-world-data proving that the vaccines from Pfizer-BioNTech and Moderna are safe. Severe adverse effects such as myocarditis, or inflammation of the heart muscle, have been reported but are typically rare.
A new investigation out Thursday found that the Food and Drug Administration, in charge of overseeing clinical trials for vaccines and treatments, only inspected a paucity of trial sites during the Covid pandemic.
Less than a third of US Food and Drug Administration drug regulation changes are backed by at least one relevant published research report, an October study warned.
This means either the FDA is taking action based on evidence that is not public, or more thorough decision-making is needed, Yale researchers said.
The findings ‘highlight the continued need for rigorous post-market safety studies to strengthen the quality of evidence available at the time of regulatory action’.
Of the 603 drug safety concerns identified in FDA’s voluntary drug safety reporting system, 70 per cent were deemed resolved
And 78 per cent of those concerns led to regulatory action.
Researchers made a separate detailed analysis of 82 drug safety concerns identified in 2014 and 2015.
Of the 76 of those that were resolved, 57 had at least one relevant study that had been identified alongside it.
Most of the studies were case reports – a follow-up of an individual patient – or case series – a group of case reports with patients who were given similar treatment.
None were verified with a public assessment.
Dr Gortler worked as an FDA medical reviewer between 2007 and 2011 and then as a senior advisor to the FDA commissioner in 2019-2021.
In the report, the FDA was also accused of a history even before the Covid pandemic of obscuring inspection reports that detail violations at clinical trial sites across the country.
The FDA has stood in the way of giving medical experts the power to weigh both the risks and the benefits of a new drug or vaccine by concealing reports of violations, Dr Gortler said.
Reporter Maryanne Demasi conducted her investigation using regulatory documents from the FDA that outlined the reasons for the vaccines’ approvals.
Ms Demasi spoke with the Texas whistleblower about her experience at the trial site as well as a former staffer in the FDA’s Office of Criminal Investigations who was also concerned about the agency’s failure to address the violations.
The BMJ investigation included information on trial sites for remdesivir, an antiviral drug from Gilead Sciences and a treatment for Covid-19. Ms Demasi said that just five of 73 remdesivir trial sites were inspected.
Concerns about the agency’s transparency around Covid vaccine trial site violations are not unprecedented.
The whistleblower Brook Jackson, a former regional director at Texas-based Ventavia Research Group contracted by the FDA to run trials of Pfizer’s shot, oversaw a trial site for two weeks in September 2020.
While there, she claimed to have seen poor lab management, workers cutting corners, and officials obscuring data and putting patients in harm’s way.
Ms Jackson said the firm did not always test patients with symptoms, which potentially masked how well the jab performed.
She also claimed that her employer hired underqualified staff as vaccinators and failed to follow-up on side effects.
After raising her concerns with Ventavia without success, Ms Jackson wrote to the FDA. She told BMJ that the FDA did not follow up on her concerns.
The FDA did not confirm whether inspectors visited the site in question following Ms Jackson’s letter.
Pfizer told DailyMail.com about the whistleblower report that the company, ‘has a robust quality management system in place for all aspects of our clinical trials, as they are the foundation of our commitment to patient safety and the integrity of our trials.
‘We take all concerns raised very seriously and thoroughly investigate them, and when necessary take swift action to address challenges or issues,’ a company spokesperson said.
A smaller number of trial sites were investigated in-person early in the pandemic. The agency scaled back in-person inspections at the height of the pandemic to protect its own workers from infection.
The FDA maintained that investigators were properly equipped to carry out their jobs despite the shift to a remote inspection protocol.
Abby Capobianco, the FDA’s press officer, told DailyMail.com: ‘The FDA takes its oversight of clinical trials very seriously and continued conducting in-person inspections in the U.S. and abroad throughout the ongoing pandemic.
‘We prioritized inspections for COVID-related products, including vaccines, ensuring FDA-regulated COVID-19 products are able to be used to save American lives.’
The claims highlighted in Wednesday’s report are the latest in a checkered history of agency transparency issues.
A 2020 investigation published in Science showed that FDA oversight of clinical trials is slow-moving, secretive, and far too lenient.
It also said that enforcement is declining due in part to persistent staffing shortages at the agency.
Despite the estimated hundreds of thousands of clinical trial sites in operation across the US and abroad, the FDA only has 89 inspectors for its bioresearch monitoring program.
A Government Accountability Office report published last January found that staff turnover at the FDA in key scientific areas was twice that of other government agencies in 2007, severely hampering its ability to fulfil its responsibilities.
Relatively low pay and morale have plunged the agency into a persistent workforce shortage.
Jill Fisher, professor of social medicine at the University of North Carolina said: ‘I don’t think that it is a sufficient number of staff to do that kind of level of oversight.’
In 2015, Charles Seife, professor of journalism at New York University, conducted an analysis of clinical trials conducted between 1998 and 2013 in which an FDA inspection found significant evidence of violations.
Some of the objectionable practices that Seife found across the trials included 22 instances of submitting false information, 35 instances of inadequate or inaccurate recordkeeping, and 30 instances of failure to protect the safety of patients and/or issues with oversight or informed consent.
In 2007, HHS’ Office of the Inspector General found the FDA audited less than 1 per cent of the nation’s clinical trial sites between 2000 and 2005.
Ms Capobianco said: ‘The agency’s investigators are essential to the FDA’s ability to help ensure the quality and safety of medical products.
‘FDA’s investigators are experienced and highly trained professionals, and the agency provides its investigators with numerous resources to support inspections and investigations.’
Despite clinical trial inspections slowing down, the vaccines concerned have proven largely safe and highly effective at preventing severe illness due to Covid-19.
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