BMJ article on malpractice, Pfizer trials

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Discussion Overview

The discussion centers around concerns raised in a BMJ article regarding the integrity of clinical trials for a vaccine, specifically focusing on issues reported by a whistleblower from Ventavia, a company involved in the trials. Participants explore the implications of these concerns on the perceived reliability of the trial data and the broader scientific community.

Discussion Character

  • Debate/contested
  • Exploratory
  • Technical explanation

Main Points Raised

  • Some participants express that while the vaccine's efficacy is supported by overwhelming data, the reported issues cast doubt on trial integrity and the scientific community's credibility.
  • Concerns were raised about specific problems during the trials, including inadequate monitoring of participants, lack of follow-up on adverse events, and improper handling of vaccine storage.
  • One participant suggests that human error is an inherent part of the trial process, indicating that such issues are not entirely unexpected.
  • Another participant argues that while the issues are concerning, they do not appear to indicate fraud or data tampering, suggesting that they are more about procedural lapses than fundamental flaws in the trial results.
  • Some participants note that real-world data from Israel corroborates the major trial results, although the impact of the reported issues on trial outcomes remains unclear.
  • A specific concern about the non-testing of symptomatic participants was mentioned, with references to analyses by Pfizer and the FDA that reportedly found no effect on results.

Areas of Agreement / Disagreement

Participants do not reach a consensus; while some acknowledge the validity of the concerns raised, others maintain that the overall integrity of the trial results remains intact despite the reported issues.

Contextual Notes

Participants highlight limitations in understanding how the reported issues may have affected trial outcomes, and there is a reliance on the definitions and interpretations of trial protocols and results.

pinball1970
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TL;DR
https://www.bmj.com/content/375/bmj.n2635

In her 25 September email to the FDA Jackson wrote that Ventavia had enrolled more than 1000 participants at three sites. The full trial (registered under NCT04368728) enrolled around 44 000 participants across 153 sites that included numerous commercial companies and academic centres. Many concerns raised.
Not what we want want to be reading in the BMJ at this time regarding trial integrity.
The Vaccine works, the data is overwhelming but this casts a shadow on the integrity of the trials and the Science community as a whole (especially seen from the tax payer/layman perspective)

Concerns raised​

In her 25 September email to the FDA Jackson wrote that Ventavia had enrolled more than 1000 participants at three sites. The full trial (registered under NCT04368728) enrolled around 44 000 participants across 153 sites that included numerous commercial companies and academic centres. She then listed a dozen concerns she had witnessed, including:
  • Participants placed in a hallway after injection and not being monitored by clinical staff
  • Lack of timely follow-up of patients who experienced adverse events
  • Protocol deviations not being reported
  • Vaccines not being stored at proper temperatures
  • Mislabelled laboratory specimens, and
  • Targeting of Ventavia staff for reporting these types of problems.
There is also a mention of patients being unblinded.

Science guys seen this? Thoughts? Or is the human factor that is part and parcel of the process?
Thanks in advance.
 
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pinball1970 said:
Science guys seen this? Thoughts? Or is the human factor that is part and parcel of the process?
Can't spell 'science' without 'humans'. Else who would spell it?
 
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To elaborate on my previous post, this isn't unexpected. Frankly I'd be amazed if no sites anywhere reported any of the problems listed above. People are flawed, fallible, and lazy. That's why the processes that inspect and report on said problems exist in the first place.
pinball1970 said:
The Vaccine works, the data is overwhelming but this casts a shadow on the integrity of the trials and the Science community as a whole (especially seen from the tax payer/layman perspective)
If its a shadow, it's a small one. There doesn't appear to be any fraud or tampering with data and results. Most of the issues listed have to do with people not doing all the little nitty gritty things that they're supposed to be doing. You don't want to know all the little things that I've seen get skipped, missed, and overlooked in my career in the Air Force.

Still, little things lead to big problems, so these obviously need to be addressed.
 
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The major trial results were quantitatively corroborated by real world data from Israel.
It's unclear how most of the issues would have affected the trial results. One of the issues - the non-testing of symptomatic participants - that could have affected the trial results, was analyzed by Pfizer and the FDA and found not to affect results.
Another point of view: https://respectfulinsolence.com/2021/11/15/wtf-happened-to-the-bmj/
What @thackerpd didn't mention: The share of non-tested trial participants was very similar in the treatment and the placebo groups (9.2% vs 10.1%), and a sensitivity check was done on this issue. https://t.co/7g4B3AUqyG pic.twitter.com/q3DDySb2KG
— Andreas Backhaus (@AndreasShrugged) November 3, 2021
 
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