6 ms·

At this point the original phase 3 trials are pretty much irrelevant, we have so much more data now from the actual use of the vaccines. They really play no rol

At this point the original phase 3 trials are pretty much irrelevant, we have so much more data now from the actual use of the vaccines. They really play no role at all now. In terms of effectivness we're three major SARS-CoV2 variants further, and for looking at rare side effects we have billions of doses now compared to tens of thousands in those trials. I'm all for putting pressure on everyone in Science to publish more raw data. This kind of data is likely more complicated because it's really hard if not impossible to anonymize the actual patient-level data. It still should be as accessible as possible to other scientists.

walterbell 5y ago
> They really play no role at all now. The (small) controlled trial data can be combined with the (large) uncontrolled mass-population data, e.g. one can look at the larger dataset for corroboration of weak signals in the smaller dataset. New controlled trials can be started, where further evidence is needed.
cyanydeez 5y ago
this stuff just smacks of iignorance and attempts to continue tompoliticize clear public health concerns. i am sure there will be a red herring in all the data that will cash a small enough shadow. but this jibbering is about dragging science down to the level of far right ignorance, which is the onlymplace concervatives can win.
- planetsprite 5y ago
  Speculation is made either way without datapoints. What's the harm in being transparent if at worst some spurious (but provably spurious) correlations mislead a few people already prone to mistrust? Higher transparency would also dissolve a lot of the claims that the pharmaceutical companies are "hiding" something regarding the actual effectiveness of their vaccines and therapeutics.
  - bigfudge 5y ago
    I don’t think people claiming pharma companies are going to be satisfied by data dumps. They will simply claim the data are fabricated. There is so little correspondence between reality and claims already- I think you’re making the mistake that the discourse is in good faith. It doesn’t seem to be to me.
diroussel 5y ago
It's hard to analyse the data from treatments, as treatments don't have a control group. Trials are designed with control groups, placebos and double-blind process to gather data and then analyse it. We may have loads of data from real people being treated, but good luck trying to analyse it in a scientific way. We need effective vaccines, and we need to be able to trust them. Just treating people with a vaccine doesn't always give that trust and confidence. (I hope I got my medical terminology right, I'm not a clinician, but have been close to covid-19 related medical research)
- fabian2k 5y ago
  It's much, much harder to understand the data if you don't have a control group. But once you have an effective treatment, you no longer have a control group if you're at all ethical. You cannot keep a working treatment from people just to do more science, that is deeply and fundamentally unethical. So the moment we knew the vaccines worked, the science got harder. Well, that point also save an enormous amount of lives, so I don't think this is something to complain about. It's still possible to do a lot of good science now, even randomized controlled trials. They just can't compare to unvaccinated groups, but you can still do stuff like compare double-vaccinated with triple vaccinated.
  - incrudible 5y ago
    A lot of data now shows that double vaccinated are infected with Omikron more often than unvaccinated. I do not know what causes this or what it means, but imagine for a moment there were no unvaccinated left: Your vaccine could be arbitrarily harmful with a new variant and you would not be able to tell.
    - fabian2k 5y ago
      That is simply wrong. There is one study that listed negative effectiveness against Omicron for the vaccines. That study did not control for any confounding factors, it simply was not designed to measure this particular thing, it was focused on a different question. There are some strong fundamental reasons why we would not expect the vaccine to be harmful with future variants. And even then we would still be able to detect if it was.
aeternum 5y ago
> This kind of data is likely more complicated because it's really hard if not impossible to anonymize the actual patient-level data. It still should be as accessible to other scientists as possible. I disagree with both parts of this. Why not associate each patient with a number then log all data against that? Patient names and other identifying information should simply never be attached to trial-related data (except for in a well-protected lookup file with highly restricted access). Making scientific data accessible only to other scientists is highly anti-scientific. Feynman, one of the greatest scientists of all time has many quotes around exactly this mindset: "Have no respect whatsoever for authority; forget who said it and instead look at what he starts with, where he ends up, and ask yourself, 'Is it reasonable?' ... we will doom humanity for a long time to the chains of authority, confined to the limits of our present imagination. It has been done so many times before." "Science is the belief in the ignorance of experts" "Our freedom to doubt was born out of a struggle against authority in the early days of science. It was a very deep and strong struggle: permit us to question - to doubt - to not be sure. I think that it is important that we do not forget this struggle and thus perhaps lose what we have gained."
- fabian2k 5y ago
  I'm not fully up to speed with all the research here, but as far as I understand it's quite easy to de-anonymize many datasets of exactly the kind you describe. If you're not really, really careful there will be lots of information in simple demographic data that could easily be matched to other data sources.
- gpm 5y ago
  > Why not associate each patient with a number then log all data against that? Patient names and other identifying information should simply never be attached to trial-related data Because "patient name" isn't the only way a patient can be identified. "Male, 27, admitted to Sunnybrook hospital for stitches to his forehead due to knife wound on January 20th 2022" is almost certainly uniquely identifying (actually it's made up so it probably identifies no one), is in the person's medical data for the trial, and clearly needs to either be redacted or in some other way separated from the other line that says "contracted HIV on January 19th 2022". Yet both are relevant when investigating causes of side effects.
nsainsbury 5y ago
Actually, I would argue we don't have good data from the use of the vaccines. Part of the reason is because all the mechanisms used for reporting things like side-effects, effectiveness, etc. have a litany of confounding variables which haven't been controlled for which could be far better corrected for/isolated with good studies. For example, when it comes to vaccine side-effects, I don't think there exists a true account for how common the side-effects really are. The most common way to report side-effects (VAERS, and similar national databases) are dismissed due to the self-reporting nature, local GPs frequently dismiss side-effects and tell people to just go home and take a Panadol with zero reporting going on (I had this happen to me - started experiencing severe chest pain 2 days post-Pfizer. Subsequently saw a cardiologist after months of pain and his comment to me was "I'm seeing young people like you daily and your cases are going widely underreported"), etc. Likewise, when it comes to vaccine effectiveness, there are a million and one confounding variables from % of the population that already had natural immunity, covid variants, health, age, seasonality, societal lockdowns, isolation, etc. Also, it's important I think for us to raise the bar to the highest possible standard when you're talking about a medical intervention that was forced under significant duress (loss of job, social stigma, public/medical shaming) on a substantial percentage of the world's population. We should not be content as a society to come within inches of worldwide medical authoritarianism without asking some seriously hard fucking questions and imposing the absolute strictest and highest possible scientific standards to justify why.
- fabian2k 5y ago
  But we actually don't need the VAERS data to examine if the vaccines are better than the alternative. We do need it to provide accurate labels for side effects, but that is all. We can simply look at infection, hospitalization and death in vaccinated and unvaccinated populations. If we properly match the populations, we can determine if the vaccine saves lives, and it turns out that they do save a lot of lives.
  - nsainsbury 5y ago
    That's true. And I agree that the vaccines have saved lives - mostly, of the old and the very sick/unhealthy. However, what is less clear today is whether there has been a net positive or negative effect of the vaccine for young healthy people. You can only come to that conclusion if you actually had high quality data and studies on vaccine side-effects, effectiveness in population groups stratified by age, health, etc. I suspect that the vaccines, mandates, lockdowns, etc. have been a net negative for the overall health of young (<50), and healthy people, and the body of scientific evidence will support this position in the future. It's just cloudy today because it's wrapped up in politics...but the science will eventually win out.
YeBanKo 5y ago
In phase 3 trial, there should be a regular follow up at set intervals, let’s say every 6 weeks, then every 9 weeks, etc. In the wild in the US healthcare realities if you receive a vaccine and then either have a breakthrough infection or any not immediate side effect, it’s not clear when this information will get back to CDC, so they can properly analyze it. Israel had much smaller data set(small population), yet they noticed myocarditis sooner.

walterbell 5y ago

> They really play no role at all now. The (small) controlled trial data can be combined with the (large) uncontrolled mass-population data, e.g. one can look at the larger dataset for corroboration of weak signals in the smaller dataset. New controlled trials can be started, where further evidence is needed.

cyanydeez 5y ago

this stuff just smacks of iignorance and attempts to continue tompoliticize clear public health concerns. i am sure there will be a red herring in all the data that will cash a small enough shadow. but this jibbering is about dragging science down to the level of far right ignorance, which is the onlymplace concervatives can win.

planetsprite 5y ago
Speculation is made either way without datapoints. What's the harm in being transparent if at worst some spurious (but provably spurious) correlations mislead a few people already prone to mistrust? Higher transparency would also dissolve a lot of the claims that the pharmaceutical companies are "hiding" something regarding the actual effectiveness of their vaccines and therapeutics.
- bigfudge 5y ago
  I don’t think people claiming pharma companies are going to be satisfied by data dumps. They will simply claim the data are fabricated. There is so little correspondence between reality and claims already- I think you’re making the mistake that the discourse is in good faith. It doesn’t seem to be to me.

diroussel 5y ago

It's hard to analyse the data from treatments, as treatments don't have a control group. Trials are designed with control groups, placebos and double-blind process to gather data and then analyse it. We may have loads of data from real people being treated, but good luck trying to analyse it in a scientific way. We need effective vaccines, and we need to be able to trust them. Just treating people with a vaccine doesn't always give that trust and confidence. (I hope I got my medical terminology right, I'm not a clinician, but have been close to covid-19 related medical research)

fabian2k 5y ago
It's much, much harder to understand the data if you don't have a control group. But once you have an effective treatment, you no longer have a control group if you're at all ethical. You cannot keep a working treatment from people just to do more science, that is deeply and fundamentally unethical. So the moment we knew the vaccines worked, the science got harder. Well, that point also save an enormous amount of lives, so I don't think this is something to complain about. It's still possible to do a lot of good science now, even randomized controlled trials. They just can't compare to unvaccinated groups, but you can still do stuff like compare double-vaccinated with triple vaccinated.
- incrudible 5y ago
  A lot of data now shows that double vaccinated are infected with Omikron more often than unvaccinated. I do not know what causes this or what it means, but imagine for a moment there were no unvaccinated left: Your vaccine could be arbitrarily harmful with a new variant and you would not be able to tell.
  - fabian2k 5y ago
    That is simply wrong. There is one study that listed negative effectiveness against Omicron for the vaccines. That study did not control for any confounding factors, it simply was not designed to measure this particular thing, it was focused on a different question. There are some strong fundamental reasons why we would not expect the vaccine to be harmful with future variants. And even then we would still be able to detect if it was.

aeternum 5y ago

> This kind of data is likely more complicated because it's really hard if not impossible to anonymize the actual patient-level data. It still should be as accessible to other scientists as possible. I disagree with both parts of this. Why not associate each patient with a number then log all data against that? Patient names and other identifying information should simply never be attached to trial-related data (except for in a well-protected lookup file with highly restricted access). Making scientific data accessible only to other scientists is highly anti-scientific. Feynman, one of the greatest scientists of all time has many quotes around exactly this mindset: "Have no respect whatsoever for authority; forget who said it and instead look at what he starts with, where he ends up, and ask yourself, 'Is it reasonable?' ... we will doom humanity for a long time to the chains of authority, confined to the limits of our present imagination. It has been done so many times before." "Science is the belief in the ignorance of experts" "Our freedom to doubt was born out of a struggle against authority in the early days of science. It was a very deep and strong struggle: permit us to question - to doubt - to not be sure. I think that it is important that we do not forget this struggle and thus perhaps lose what we have gained."

fabian2k 5y ago
I'm not fully up to speed with all the research here, but as far as I understand it's quite easy to de-anonymize many datasets of exactly the kind you describe. If you're not really, really careful there will be lots of information in simple demographic data that could easily be matched to other data sources.
gpm 5y ago
> Why not associate each patient with a number then log all data against that? Patient names and other identifying information should simply never be attached to trial-related data Because "patient name" isn't the only way a patient can be identified. "Male, 27, admitted to Sunnybrook hospital for stitches to his forehead due to knife wound on January 20th 2022" is almost certainly uniquely identifying (actually it's made up so it probably identifies no one), is in the person's medical data for the trial, and clearly needs to either be redacted or in some other way separated from the other line that says "contracted HIV on January 19th 2022". Yet both are relevant when investigating causes of side effects.

nsainsbury 5y ago

Actually, I would argue we don't have good data from the use of the vaccines. Part of the reason is because all the mechanisms used for reporting things like side-effects, effectiveness, etc. have a litany of confounding variables which haven't been controlled for which could be far better corrected for/isolated with good studies. For example, when it comes to vaccine side-effects, I don't think there exists a true account for how common the side-effects really are. The most common way to report side-effects (VAERS, and similar national databases) are dismissed due to the self-reporting nature, local GPs frequently dismiss side-effects and tell people to just go home and take a Panadol with zero reporting going on (I had this happen to me - started experiencing severe chest pain 2 days post-Pfizer. Subsequently saw a cardiologist after months of pain and his comment to me was "I'm seeing young people like you daily and your cases are going widely underreported"), etc. Likewise, when it comes to vaccine effectiveness, there are a million and one confounding variables from % of the population that already had natural immunity, covid variants, health, age, seasonality, societal lockdowns, isolation, etc. Also, it's important I think for us to raise the bar to the highest possible standard when you're talking about a medical intervention that was forced under significant duress (loss of job, social stigma, public/medical shaming) on a substantial percentage of the world's population. We should not be content as a society to come within inches of worldwide medical authoritarianism without asking some seriously hard fucking questions and imposing the absolute strictest and highest possible scientific standards to justify why.

fabian2k 5y ago
But we actually don't need the VAERS data to examine if the vaccines are better than the alternative. We do need it to provide accurate labels for side effects, but that is all. We can simply look at infection, hospitalization and death in vaccinated and unvaccinated populations. If we properly match the populations, we can determine if the vaccine saves lives, and it turns out that they do save a lot of lives.
- nsainsbury 5y ago
  That's true. And I agree that the vaccines have saved lives - mostly, of the old and the very sick/unhealthy. However, what is less clear today is whether there has been a net positive or negative effect of the vaccine for young healthy people. You can only come to that conclusion if you actually had high quality data and studies on vaccine side-effects, effectiveness in population groups stratified by age, health, etc. I suspect that the vaccines, mandates, lockdowns, etc. have been a net negative for the overall health of young (<50), and healthy people, and the body of scientific evidence will support this position in the future. It's just cloudy today because it's wrapped up in politics...but the science will eventually win out.

YeBanKo 5y ago

In phase 3 trial, there should be a regular follow up at set intervals, let’s say every 6 weeks, then every 9 weeks, etc. In the wild in the US healthcare realities if you receive a vaccine and then either have a breakthrough infection or any not immediate side effect, it’s not clear when this information will get back to CDC, so they can properly analyze it. Israel had much smaller data set(small population), yet they noticed myocarditis sooner.