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Covid-19: Researcher blows the whistle on data integrity issues in Pfizer’s vaccine trial
Covid-19: Researcher blows the whistle on data integrity issues in Pfizer’s vaccine trial
Revelations of poor practices at a contract research company helping to carry out Pfizer’s pivotal covid-19 vaccine trial raise questions about data integrity and regulatory oversight. Paul D Thacker reports In autumn 2020 Pfizer’s chairman and chief executive, Albert Bourla, released an open letter to the billions of people around the world who were investing their hopes in a safe and effective covid-19 vaccine to end the pandemic. “As I’ve said before, we are operating at the speed of science,” Bourla wrote, explaining to the public when they could expect a Pfizer vaccine to be authorised in the United States.1 But, for researchers who were testing Pfizer’s vaccine at several sites in Texas during that autumn, speed may have come at the cost of data integrity and patient safety. A regional director who was employed at the research organisation Ventavia Research Group has told The BMJ that the company falsified data, unblinded patients, employed inadequately trained vaccinators, and was slow to follow up on adverse events reported in Pfizer’s pivotal phase III trial. Staff who conducted quality control checks were overwhelmed by the volume of problems they were finding. After repeatedly notifying Ventavia of these problems, the regional director, Brook Jackson (video 1), emailed a complaint to the US Food and Drug Administration (FDA). Ventavia fired her later the same day. Jackson has provided The BMJ with dozens of internal company documents, photos, audio recordings, and emails. Video 1 Whistleblower Brook Jackson tells The BMJ about her experience working on the Pfizer covid-19 vaccine trial 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, …
·bmj.com·
Covid-19: Researcher blows the whistle on data integrity issues in Pfizer’s vaccine trial
Facebook versus the BMJ: when fact checking goes wrong
Facebook versus the BMJ: when fact checking goes wrong
The BMJ has locked horns with Facebook and the gatekeepers of international fact checking after one of its investigations was wrongly labelled with “missing context” and censored on the world’s largest social network. Rebecca Coombes and Madlen Davies report On 3 November Howard Kaplan, a retired dentist from Israel, posted a link to a BMJ investigation article in a private Facebook group.1 The investigation reported poor clinical trial research practices occurring at Ventavia, a contract research company helping to carry out the main Pfizer covid-19 vaccine trial.2 The article brought in record traffic to bmj.com and was widely shared on Twitter, helping it achieve the second highest “Altmetric” score of all time across all biomedical publications.3 But a week after his posting Kaplan woke up to a message from Facebook (fig 1). Fig 1 Clockwise from top left: Facebook’s “missing context” notice; administrators of a private group were warned of a “partly false” post; Facebook’s warning on Howard Kaplan’s original post; Cochrane’s tweet after being “shadowbanned” by Instagram “The Facebook Thought Police has issued me a dire warning,” he wrote in a new post. “Facebook’s ‘independent fact-checker’ doesn’t like the wording of the article by the BMJ. And if I don’t delete my post, they are threatening to make my posts less visible. Obviously, I will not delete my post . . . If it seems like I’ve disappeared for a while, you’ll know why.”4 Kaplan was not the only Facebook user having problems. Soon, several BMJ readers were alerting the journal to Facebook’s censorship. Over the past two months the journal’s editorial staff have been navigating the opaque appeals process without success, and still today their investigation remains obscured on Facebook. The experience has highlighted serious concerns about the “fact checking” being undertaken by third party …
·bmj.com·
Facebook versus the BMJ: when fact checking goes wrong
Pandemrix vaccine: why was the public not told of early warning signs?
Pandemrix vaccine: why was the public not told of early warning signs?
Eight years after the pandemic influenza outbreak, a lawsuit alleging that GlaxoSmithKline’s Pandemrix vaccine caused narcolepsy has unearthed internal reports suggesting problems with the vaccine’s safety. Peter Doshi asks what this means for the future of transparency during public health emergencies In October 2009, the US National Institutes of Health infectious diseases chief, Anthony Fauci, appeared on YouTube to reassure Americans about the safety of the “swine flu” vaccine. “The track record for serious adverse events is very good. It’s very, very, very rare that you ever see anything that’s associated with the vaccine that’s a serious event,”1 he said. Four months earlier, the World Health Organization had declared H1N1 influenza a pandemic, and by October 2009 the new vaccines were being rolled out across the world. A similar story was playing out in the UK, with prominent organisations, including the Department of Health, British Medical Association, and Royal Colleges of General Practitioners, working hard to convince a reluctant NHS workforce to get vaccinated.2 “We fully support the swine flu vaccination programme … The vaccine has been thoroughly tested,” they declared in a joint statement.3 Except, it hadn’t. Anticipating a severe influenza pandemic, governments around the world had made various logistical and legal arrangements to shorten the time between recognition of a pandemic virus and the production of a vaccine and administration of that vaccine in the population. In Europe, one element of those plans was an agreement to grant licences to pandemic vaccines based on data from pre-pandemic “mock-up” vaccines produced using a different virus (H5N1 influenza). Another element, adopted by countries such as Canada, the US, UK, France, and Germany, was to provide vaccine manufacturers indemnity from liability for wrongdoing, thereby reducing the risk of a lawsuit stemming from vaccine related injury.45 In …
·bmj.com·
Pandemrix vaccine: why was the public not told of early warning signs?
These NHS Staff Were Told The Swine Flu Vaccine Was Safe, And They're Suffering The Consequences
These NHS Staff Were Told The Swine Flu Vaccine Was Safe, And They're Suffering The Consequences
Dozens of NHS workers are fighting for compensation after developing narcolepsy from a swine flu vaccine that was rushed into service without the usual testing when the disease spread across the globe in 2009. They say it has destroyed their careers and their health.
·buzzfeed.com·
These NHS Staff Were Told The Swine Flu Vaccine Was Safe, And They're Suffering The Consequences
Striking Correlation Between Autumn Vaccine Boosters and Excess Deaths in England as Total Non-Covid Excess Tops 23,000 – The Daily Sceptic
Striking Correlation Between Autumn Vaccine Boosters and Excess Deaths in England as Total Non-Covid Excess Tops 23,000 – The Daily Sceptic
A striking correlation has appeared between excess deaths and autumn Covid booster doses in England, raising new questions of safety as total non-Covid excess deaths hit 23,287 since April.
·dailysceptic.org·
Striking Correlation Between Autumn Vaccine Boosters and Excess Deaths in England as Total Non-Covid Excess Tops 23,000 – The Daily Sceptic