Covid-19: Researcher blows the whistle on data integrity issues in Pfizer’s vaccine trial
www.bmj.com
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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, 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. 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, she repeatedly informed her superiors of poor laboratory management, patient safety concerns, and data integrity issues. Jackson was …

Pfizer rushed their trials and used their lobbying power to attempt to increase profits from the pandemic. Later data from the real world showed that their efficacy scores were lower than in the initial trials and not that much higher than rival cheaper vaccines.

Pfizer also did all these ethically dubious things without having enough manufacturing capacity to fulfill potential orders from the whole world, making it somewhat needlessly damaging

Christian
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123d

Pfizer also did all these ethically dubious things without having enough manufacturing capacity to fulfill potential orders from the whole world, making it somewhat needlessly damaging

I’m kind of slow, could you elaborate on this point?

@chad1234
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123d

you mean the manufacturing capacity part? Nations who did not place their orders very early would have had to wait a long time and many went with alternatives which did not have such a long wait

Christian
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I mean I know that and I get that the whistleblower is calling them out for bad scientific practices in the name of profits, I’m just confused as to how the two points are connected.

@huginn
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223d

Them having the “best” vaccine allowed them to secure a lot of orders, while still scrambling to actually fulfill the orders because of the complex and novel production process. This led to delays which is not a good thing when it comes to a critical vaccine…

@chad1234
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it is somewhat amusing that they may not have actually increased their sales by cheating

@chad1234
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23d

the stuff in the first paragraph

The bad things happening in ttheir trials were covered up and no attempt was made to address them before they got approval. Rival vaccine makers had reported various mistakes made in the trials and suffered delays due to having to rectify them

Pfizer also got the US media to run hit pieces on rival vaccines from other nations to attempt to boost sales.

Pfizer’s contract with various nations included various clauses allowing them to seize national assets

@CriticalResist8
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Is there stuff about the Moderna vaccine too? I got that one instead of Pfizer exactly because I kept hearing concerning things about the latter.

@chad1234
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I’ve not looked at it much so I am not sure. However Moderna would not have had as much money to do as much aggressive lobbying and PR

I got vaccinated after most people so more info about side effects revealed across a larger number of people in the public by then so I did not need to weigh much on their unethical behavior in my choice on which

its still early and long term side effects may later be revealed

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