11 ms·

Covid-19: Researcher blows the whistle on Pfizer vaccine trial data integrity

104 points by AndrewBissell 5y ago

alea_iacta_est 5y ago
meanwhile: Today in the WSJ: CDC Advisers Consider Pfizer Shot for Young Children
- AndrewBissell 5y ago
  Not to worry, that trial was so small and underpowered there's almost no data about which to have any integrity concerns.
  - sjg007 5y ago
    Stop spreading disinformation.
    - AndrewBissell 5y ago
      A 3 month trial with 1500 participants in the vaccine arm is a joke.
    - ProjectArcturis 5y ago
      I'm no antivaxxer, but how are you ever going to uncover side effects that occur in 1 in 10,000 doses if you only have 1,500 patients? I certainly wouldn't want my child to be at the front of the line getting this vaccine.
    - noslashs 5y ago
      Although most people will probably know you're being sarcastic, I still think you should add a /s at the end.
    - akomtu 5y ago
      Is it Ministry of Truth here?
  - mewpmewp2 5y ago
    And the one child with adverse effects was removed from the study, so general public doesn't have to worry.
angelzen 5y ago
What I still can't wrap my head around is that they vaccinated the control group after less than a year and got away with it. Here we are, with a novel coronavirus, a novel vaccine technology and a novel vaccine, and we can't even do a 2 year longterm study. > "During that visit we discussed the options, which included staying in the study without the vaccine," he says, "and amazingly there were people — a couple of people — who chose that." He suspects those individuals got spooked by rumors about the vaccine. But everybody else who had the placebo shot went ahead and got the actual vaccine. So now Fierro has essentially no comparison group left for the ongoing study. https://www.npr.org/sections/health-shots/2021/02/19/969143015/long-term-studies-of-covid-19-vaccines-hurt-by-placebo-recipients-getting-immuni https://www.npr.org/sections/health-shots/2021/02/19/9691430...
- dekhn 5y ago
  Have you carried out clinical trials before, done any sort of public health research, or worked in any way in science that involves people? When you say "got away with it" it sounds like you think they were intentionally carrying out a conspiracy theory. The reality is far more banal.
  - raxxorrax 5y ago
    I did for non-invasive devices that were mostly class I + II. Even for those 1-2 years is very fast. Larger manufacturers might be quicker, but it is the time you should calculate with at minimum. I think the state of emergency allows to cut the time short, because these are very short time frames for clinical trials.
  - angelzen 5y ago
    Somebody was kind enough to explain in a fair amount of detail how the process goes. It is an difficult ethical question. Mine is also an unfortunate formulation, perhaps "went under the radar" reflects the sentiment better. Here we are, managing a deadly pandemic with a novel technology and no depth line. All of this to say, given that there is no shortage of people willing to weather covid without a vaccine (17% of adults "definitely not" or "only if required" as of July 2021), perhaps there is a way to ethically design a study of the vaccines that doesn't lose its control group after less than a year. To risk "conspiratorial thinking" charges, what are the odds that in a country with 31% unvaccinated adults, only 2 participants in the control arm of a critical RCT didn't want to take the vaccine as soon as it was offered? https://www.nytimes.com/2021/07/31/us/virus-unvaccinated-americans.html https://www.nytimes.com/2021/07/31/us/virus-unvaccinated-ame... Edit: The study the NYT article references: https://www.kff.org/coronavirus-covid-19/poll-finding/kff-covid-19-vaccine-monitor-july-2021 https://www.kff.org/coronavirus-covid-19/poll-finding/kff-co... Edited the numbers to reflect the original source.
sterlind 5y ago
The alleged issues apply to only a small subset of the clinical sites/volunteers in the trial: > 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. Ventavia looks sketchy, but this affects 1/44th of the patients and 3/153 of the sites. There's nothing to suggest they fudged the numbers in Pfizer's favor either, only that they were sloppy.
- AndrewBissell 5y ago
  The greater cause for concern is the fact that the whistleblower submitted a report to the FDA which was ignored, and was then fired in retaliation. That suggests the possible presence of systemic weaknesses with much broader impact beyond Ventavia. The inability to swab 477 trial participants to test for SARS-CoV-2 infection is also pretty bad given that confirmed symptomatic cases of COVID were the metric used to establish the efficacy numbers in the trial.
  - sterlind 5y ago
    did someone in the FDA disclose the whistleblower's identity to Ventavia? or did they figure it out on their own? retaliation either way, but I didn't see any evidence of conspiracy in the article.
    - AndrewBissell 5y ago
      Yeah the article doesn't make it clear. In my own reading I had assumed Ventavia figured it out on its own.
  - mewpmewp2 5y ago
    There's countless of other questions and concerns this article brings up in my view. You must really give benefit of the doubt to Pfizer to not expect there to be something wrong with the final data.
thorum 5y ago
> Since Jackson reported problems with Ventavia to the FDA in September 2020, Pfizer has hired Ventavia as a research subcontractor on four other vaccine clinical trials (covid-19 vaccine in children and young adults, pregnant women, and a booster dose, as well an RSV vaccine trial
deleted 5y ago
[deleted]
charbonneau2 5y ago
Most trials fail. But many of those failures are preventable. The Lean Trial is a new approach being adopted across the globe, changing the way companies perform medical research. The Lean Trial approach fosters companies that are both more capital efficient and that leverage human creativity more effectively. Inspired by lessons from breakthrough healthcare startups, it relies on improving data ("Falsify Until You Qualify®"), employing Pareto-trained® workers (80% of knowledge comes from 20% of training), as well as a number of counter-intuitive practices that measure actual progress without resorting to vanity metrics like adverse event reports. It enables a company to pivot with agility, deviating from protocols inch by inch, minute by minute.
deleted 5y ago
[deleted]
twofornone 5y ago
Why are we suddenly pretending that the same industry that gave us the opioid crisis (in addition to dozens of other serious unethical practices for which they've been sued) is suddenly above shady research and massaging of results? Particularly when they have been legally absolved of liability and stand to gain tens-hundreds of billions of dollars? It doesn't take a conspiracy. Just a little pressure from upper management. People don't want to lose their jobs and usually the way these things go only a handful of employees are actually involved in fraud while the rest are unaware or look the other way when confronted with suspicious circumstances. This pandemic is not an excuse to give pharmaceutical companies the free reign to rake in cash with no accountability. And that accountability comes not just from government, but from laypeople too. It took five years to discover that thalidomide was causing severe birth defects in children, and the covid vaccines are based on an untested technology. I'm not being "anti-vaxx" here, just trying to offer up some common sense: when money is involved, there is no limit to what executives and unscrupulous employees are willing to do if they think they can get away with it. And in a complex system with so many moving parts, a handful of seemingly innocuous violations of good practices can combine to produce a serious outcome. We should all be far more critical of this entire rushed process, especially in light of not just financial but political pressure to produce evidence of a working vaccine. Edit: I didn't even bring up regulatory capture that we've also suddenly forgotten all about. The former FDA commissioner is on Pfizer's board of directors. As is the CEO of Reuters. Our economic system is ethically sick, the pandemic did not suddenly fix it.

104 points by AndrewBissell 5y ago

alea_iacta_est 5y ago

meanwhile: Today in the WSJ: CDC Advisers Consider Pfizer Shot for Young Children

AndrewBissell 5y ago
Not to worry, that trial was so small and underpowered there's almost no data about which to have any integrity concerns.
- sjg007 5y ago
  Stop spreading disinformation.
  - AndrewBissell 5y ago
    A 3 month trial with 1500 participants in the vaccine arm is a joke.
  - ProjectArcturis 5y ago
    I'm no antivaxxer, but how are you ever going to uncover side effects that occur in 1 in 10,000 doses if you only have 1,500 patients? I certainly wouldn't want my child to be at the front of the line getting this vaccine.
  - noslashs 5y ago
    Although most people will probably know you're being sarcastic, I still think you should add a /s at the end.
  - akomtu 5y ago
    Is it Ministry of Truth here?
- mewpmewp2 5y ago
  And the one child with adverse effects was removed from the study, so general public doesn't have to worry.

angelzen 5y ago

What I still can't wrap my head around is that they vaccinated the control group after less than a year and got away with it. Here we are, with a novel coronavirus, a novel vaccine technology and a novel vaccine, and we can't even do a 2 year longterm study. > "During that visit we discussed the options, which included staying in the study without the vaccine," he says, "and amazingly there were people — a couple of people — who chose that." He suspects those individuals got spooked by rumors about the vaccine. But everybody else who had the placebo shot went ahead and got the actual vaccine. So now Fierro has essentially no comparison group left for the ongoing study. https://www.npr.org/sections/health-shots/2021/02/19/969143015/long-term-studies-of-covid-19-vaccines-hurt-by-placebo-recipients-getting-immuni https://www.npr.org/sections/health-shots/2021/02/19/9691430...

dekhn 5y ago
Have you carried out clinical trials before, done any sort of public health research, or worked in any way in science that involves people? When you say "got away with it" it sounds like you think they were intentionally carrying out a conspiracy theory. The reality is far more banal.
- raxxorrax 5y ago
  I did for non-invasive devices that were mostly class I + II. Even for those 1-2 years is very fast. Larger manufacturers might be quicker, but it is the time you should calculate with at minimum. I think the state of emergency allows to cut the time short, because these are very short time frames for clinical trials.
- angelzen 5y ago
  Somebody was kind enough to explain in a fair amount of detail how the process goes. It is an difficult ethical question. Mine is also an unfortunate formulation, perhaps "went under the radar" reflects the sentiment better. Here we are, managing a deadly pandemic with a novel technology and no depth line. All of this to say, given that there is no shortage of people willing to weather covid without a vaccine (17% of adults "definitely not" or "only if required" as of July 2021), perhaps there is a way to ethically design a study of the vaccines that doesn't lose its control group after less than a year. To risk "conspiratorial thinking" charges, what are the odds that in a country with 31% unvaccinated adults, only 2 participants in the control arm of a critical RCT didn't want to take the vaccine as soon as it was offered? https://www.nytimes.com/2021/07/31/us/virus-unvaccinated-americans.html https://www.nytimes.com/2021/07/31/us/virus-unvaccinated-ame... Edit: The study the NYT article references: https://www.kff.org/coronavirus-covid-19/poll-finding/kff-covid-19-vaccine-monitor-july-2021 https://www.kff.org/coronavirus-covid-19/poll-finding/kff-co... Edited the numbers to reflect the original source.

sterlind 5y ago

The alleged issues apply to only a small subset of the clinical sites/volunteers in the trial: > 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. Ventavia looks sketchy, but this affects 1/44th of the patients and 3/153 of the sites. There's nothing to suggest they fudged the numbers in Pfizer's favor either, only that they were sloppy.

AndrewBissell 5y ago
The greater cause for concern is the fact that the whistleblower submitted a report to the FDA which was ignored, and was then fired in retaliation. That suggests the possible presence of systemic weaknesses with much broader impact beyond Ventavia. The inability to swab 477 trial participants to test for SARS-CoV-2 infection is also pretty bad given that confirmed symptomatic cases of COVID were the metric used to establish the efficacy numbers in the trial.
- sterlind 5y ago
  did someone in the FDA disclose the whistleblower's identity to Ventavia? or did they figure it out on their own? retaliation either way, but I didn't see any evidence of conspiracy in the article.
  - AndrewBissell 5y ago
    Yeah the article doesn't make it clear. In my own reading I had assumed Ventavia figured it out on its own.
- mewpmewp2 5y ago
  There's countless of other questions and concerns this article brings up in my view. You must really give benefit of the doubt to Pfizer to not expect there to be something wrong with the final data.

thorum 5y ago

> Since Jackson reported problems with Ventavia to the FDA in September 2020, Pfizer has hired Ventavia as a research subcontractor on four other vaccine clinical trials (covid-19 vaccine in children and young adults, pregnant women, and a booster dose, as well an RSV vaccine trial

deleted 5y ago

[deleted]

charbonneau2 5y ago

Most trials fail. But many of those failures are preventable. The Lean Trial is a new approach being adopted across the globe, changing the way companies perform medical research. The Lean Trial approach fosters companies that are both more capital efficient and that leverage human creativity more effectively. Inspired by lessons from breakthrough healthcare startups, it relies on improving data ("Falsify Until You Qualify®"), employing Pareto-trained® workers (80% of knowledge comes from 20% of training), as well as a number of counter-intuitive practices that measure actual progress without resorting to vanity metrics like adverse event reports. It enables a company to pivot with agility, deviating from protocols inch by inch, minute by minute.

deleted 5y ago

[deleted]

twofornone 5y ago

Why are we suddenly pretending that the same industry that gave us the opioid crisis (in addition to dozens of other serious unethical practices for which they've been sued) is suddenly above shady research and massaging of results? Particularly when they have been legally absolved of liability and stand to gain tens-hundreds of billions of dollars? It doesn't take a conspiracy. Just a little pressure from upper management. People don't want to lose their jobs and usually the way these things go only a handful of employees are actually involved in fraud while the rest are unaware or look the other way when confronted with suspicious circumstances. This pandemic is not an excuse to give pharmaceutical companies the free reign to rake in cash with no accountability. And that accountability comes not just from government, but from laypeople too. It took five years to discover that thalidomide was causing severe birth defects in children, and the covid vaccines are based on an untested technology. I'm not being "anti-vaxx" here, just trying to offer up some common sense: when money is involved, there is no limit to what executives and unscrupulous employees are willing to do if they think they can get away with it. And in a complex system with so many moving parts, a handful of seemingly innocuous violations of good practices can combine to produce a serious outcome. We should all be far more critical of this entire rushed process, especially in light of not just financial but political pressure to produce evidence of a working vaccine. Edit: I didn't even bring up regulatory capture that we've also suddenly forgotten all about. The former FDA commissioner is on Pfizer's board of directors. As is the CEO of Reuters. Our economic system is ethically sick, the pandemic did not suddenly fix it.