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Covid-19 vaccines and treatments: we must have raw data, now

bmj.com

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Re: Covid-19 vaccines and treatments: we must have raw data, now

#91

Post by fabian2k »

nsainsbury wrote: post #82
fabian2k wrote: post #14

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 publis…

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 a…

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.

Re: Covid-19 vaccines and treatments: we must have raw data, now

#92

Post by timr »

mike_d wrote: post #63
diroussel wrote: post #36

Earlier quoted context omitted.

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 does…

Depending on the phase of clinical trials, they don't need to be double blind or controlled. You can absolutely analyze real world mass vaccination data in a scientific way. Just treat pre-vaccination and post-vaccination as two different patients. The numbers are so large that other factors (environmental, genetics, etc) cancel out. So if your post-vaccination population has a rate of heart attacks 80% lower than th…

> You can absolutely analyze real world mass vaccination data in a scientific way. Just treat pre-vaccination and post-vaccination as two different patients.

Yes, you can do this. No, it's not the same.

With this kind of uncontrolled, longitudinal study, yes, some things are quasi-controlled: genetics, possibly lifestyle, other drugs, etc. Anything that plausibly doesn't change (much) in a single person from time A to time B.

Some things you can't control for, but still matter: changes in behavior due to the event itself. Placebo effect. Sample bias (e.g. the patients receiving treatment X were selected to receive treatment X because it was felt that they would benefit from it. This is subtle, but can really mislead. In the example of vaccination, imagine that the people most likely to vaccinate their young kids are also the ones most likely to keep their kids isolated at home, in a protective bubble...)

> So if your post-vaccination population has a rate of heart attacks 80% lower than the established norm, you know that is worth further investigation.

The key part of that is the last three words: worth further investigation. To get the final answer, you still need a controlled experiment.

Re: Covid-19 vaccines and treatments: we must have raw data, now

#93

Post by [deleted] »

YXNjaGVyZWdlbgo wrote: post #10
diroussel wrote: post #3

The BMJ seems to be on good form. First publishing the whistle blower account of pfizer [1], and now this call for raw vaccine trial data. I commend them on this approach, and can only hope that the vaccines are as safe and effective as we have been told. [1] https://www.bmj.com/content/375/bmj.n2635 - "Covid-19: Researcher blows the whistle on data integrity issues in Pfizer’s vaccine trial"

I can only recommend this article about bmj: https://respectfulinsolence.com/2021/11/15/wtf-happened-to-t...

[deleted]

Re: Covid-19 vaccines and treatments: we must have raw data, now

#94

Post by throwawaygh »

rvnx wrote: post #86
invokestatic wrote: post #59

I’m a software consultant for Pharma companies and have worked on projects that used the same kind of study design as the Pfizer COVID vaccine (Kaplan-Meier). “Raw data” is submitted to the FDA in the CDISC format. This format contains a lot of pretty sensitive medical information, including which diseases a patient has, their medical history, what drugs they take, etc. This is supposed to be anonymized, but if the p…

And ? Where is the bad thing to open a dataset of comorbidities and related / suspected effect of vaccines / medications ?

What is your full name and address? Age? Weight? Height? Eye color? Blood pressure? What STDs do you have, if any? How often and how much do you drink? Smoke? Any history of drug use? Mental disorders? What about your family?

Where is the bad thing in you posting this information here right now?

Actually, that's not even analogous. A better analogy would be you post all this info under a pseudonym -- e.g., "rvnx" or something like that -- and then the mods doxing you without your consent.

Re: Covid-19 vaccines and treatments: we must have raw data, now

#95

Post by ceejayoz »

ALittleLight wrote: post #84
ceejayoz wrote: post #32

Earlier quoted context omitted.

> Do you disagree with anything in the article? Absolutely, yes. I believe there to be an acute public health interest in not letting antivax nuts run wild on raw data like they do with VAERS, despite clear disclaimers not to do so. Additionally, as a participant in a couple of trials, I see a significant benefit to careful review before the release of data that might inadvertently reveal my identity, conditions, med…

Ahh, trust in institutions through obscurity.

Trust in institutions through difficulty of a global cover-up requiring the cooperation of nearly two hundred countries across nearly ten billion doses administered? Sure.

Re: Covid-19 vaccines and treatments: we must have raw data, now

#96

Post by fabian2k »

incrudible wrote: post #81
fabian2k wrote: post #67

Earlier quoted context omitted.

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…

It is not one study, national data from Denmark, UK, Germany and Canada shows that double vaccinated are infected at a higher rate. I am not jumping to conclusions that this means efficacy is negative, because that would require a controlled trial with an unvaccinated group. Do you catch my drift?

Please show the data that claims that double vaccinated are more likely to be infected than unvaccinated people by Omicron. And raw infection counts are not an answer here as the vaccinated and unvaccinated people are clearly not matched populations you can compare without adjustments.

Re: Covid-19 vaccines and treatments: we must have raw data, now

#97

Post by rvnx »

jjulius wrote: post #88
rvnx wrote: post #86

Earlier quoted context omitted.

And ? Where is the bad thing to open a dataset of comorbidities and related / suspected effect of vaccines / medications ?

>And ? What's not to get? OP said: >... I strongly believe there is enough information to re-identify patients. Their concern is that just dumping raw data like this into the public would be a massive violation of privacy for countless individuals.

Re-identify based on what ? There are no databases that you can link against if you strip out the major identifiers (like city and date of birth).

It's for the benefit of patients, and this raw data is already available, but under a loose NDA for commercial partners and researchers...

Re: Covid-19 vaccines and treatments: we must have raw data, now

#98

Post by nsainsbury »

fabian2k wrote: post #91
nsainsbury wrote: post #82

Earlier quoted context omitted.

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 a…

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.

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.

Re: Covid-19 vaccines and treatments: we must have raw data, now

#99

Post by bigfudge »

incrudible wrote: post #81
fabian2k wrote: post #67

Earlier quoted context omitted.

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…

It is not one study, national data from Denmark, UK, Germany and Canada shows that double vaccinated are infected at a higher rate. I am not jumping to conclusions that this means efficacy is negative, because that would require a controlled trial with an unvaccinated group. Do you catch my drift?

There’s no way of running a controlled trial of this sort when 80% of the population have already been vaccinated. You can design better or larger observational studies though.

Re: Covid-19 vaccines and treatments: we must have raw data, now

#100

Post by cogman10 »

throwawaygh wrote: post #94
rvnx wrote: post #86

Earlier quoted context omitted.

And ? Where is the bad thing to open a dataset of comorbidities and related / suspected effect of vaccines / medications ?

What is your full name and address? Age? Weight? Height? Eye color? Blood pressure? What STDs do you have, if any? How often and how much do you drink? Smoke? Any history of drug use? Mental disorders? What about your family? Where is the bad thing in you posting this information here right now? Actually, that's not even analogous. A better analogy would be you post all this info under a pseudonym -- e.g., "rvnx" or…

I'm 36, I weigh 190 lbs, I'm 6'1. My eyes are green. Blood pressure 120/80 (last I checked). No STDs. I drink once a week about 3 servings. I don't smoke. I don't use drugs or have a history of mental disorders. Depression runs in my family.

I only really hesitate to post full name and address but, frankly, I'm sure given my user handle it wouldn't be terribly hard for someone to find both of those.

So tell me, what harm have I done to myself by sharing this information?

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