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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

#201

Post by ekianjo »

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…

> 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 public were to be able to get this info, I strongly believe there is enough information to re-identify patients

At the time when you inject hundreds of millions of people with it, I'd say this should be mandatory to disclose as much information as possible regarding the actual trials. I don't trust the FDA one bit.

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

#202

Post by ceejayoz »

rvnx wrote: post #200
ceejayoz wrote: post #194

Earlier quoted context omitted.

Cool. Now you’ve got a whopping pile of selection bias added to the dataset.

Yeah, useful selectors for researchers, and still no identity. We learnt that somewhere there is a man/woman that is depressed and has weight management issue. We can take policy actions in order to improve the situation and monitor how this affects life of people (e.g. how much antidepressants are used in a year, are the food policies effective, what conditions are often linked to sudden cardiac arrest, etc). And "R…

No, you’re missing the point.

Asking people in the study if it’s OK to release their data means the resulting data set is skewed. People with certain conditions and other variables will be more or less likely to agree, leaving a non-representative sample of the actual study.

It will no longer be random.

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

#203

Post by rsfern »

rvnx wrote: post #193
ModernMech wrote: post #120

Earlier quoted context omitted.

> I don't use drugs or have a history of metal disorders. Very happy for you, but if you did, you might have learned by now that people (and employers) can treat you very differently after they find out you're an addict or have a mental disorder, and it's best not to telegraph that information to everyone except close friends you can trust.

Don't they ask in the US when you apply for a job if you have any significant disability / disease ? I remember seeing that in many of the job application forms (which I find strange actually).

I don’t think they are allowed to ask those questions. They certainly aren’t allowed to discriminate in hiring or employment based on disabilities

https://www.eeoc.gov/laws/guidance/your-employment-rights-in...

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

#204

Post by mberning »

jeromegv wrote: post #133
mberning wrote: post #24

It’s incredible how quickly pharmaceutical companies rehabbed their deservedly awful reputation by using the pandemic. Years from now, maybe decades, I’m sure we will find out there were very troubling results from the clinical trials that were swept under the rug.

You don't need to focus your conspiracy theory on clinical trials, there are billions of people who got the vaccine. Are you saying that every single of all those countries are part of a giant conspiracy that are hiding the impact of the vaccine under the rug?

It’s not a conspiracy theory. The number of reports to VAERS, which is the best data we have on population wide side effects, has been growing rapidly. To be fair it will be very hard to tease out strong evidence from that data set, but directionally it seems to indicate something is going on with these vaccines. Perhaps the clinical trial data will be released, VAERS will be combed through, new studies devised, and we will have some idea of the actual side effects and their relative frequency. It’s not going to be zero across the board. And that is just for the short term.

We have zero idea what the long term side effects may be. I hope it is zero. But if it’s not there are going to be some very unfortunate people.

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

#205

Post by leppr »

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…

> 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"

Orthogonal to the original conversation but have your cardiologist consultations yielded anything?

I also have chest pain for now more than 2 months after the second dose of the Biontech mRNA vaccine, but the tests revealed nothing abnormal. A few people in my entourage have been having similar symptoms but theirs has since receeded.

It doesn't help that search engine results for anything close to "Covid-19 Vaccine Chest Pain" are overran by both antivax conspiracy theorists and obvious propaganda. I couldn't find concrete information save from a few disparate accounts of similar conditions[1], despite the apparent frequency of those symptoms.

[1]: https://spectator.com.au/2021/11/my-post-vaccine-chest-pain-...

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

#206

Post by rsfern »

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…

VAERS is for surfacing hypotheses about rare side effects

For serious risk quantification and causal analysis, we have things like the vaccine safety datalink, which links all electronic health records across a bunch of hospital systems, covering IIRC 3% of the US population. The UK has something similar I think. I think transparency in that system (VSD) could be better, but it has the same problem this thread is discussing, that anonymizing the records may be at odds with making the analysis reproducible.

https://pubmed.ncbi.nlm.nih.gov/34477809/

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

#207

Post by invokestatic »

tpoacher wrote: post #180
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…

I hear the concern, but no. There are ways to inject randomness into a dataset, giving subjects plausible deniability without compromising the integrity of the outputs. See https://pair.withgoogle.com/explorables/anonymization/ for a nice example. Bottom line is, there are ways to share such data safely. Whether the data owner cares enough to do the extra work, especially if doing so removes a competitive advantage,…

I have no qualms with releasing a subset of the data that is properly and irreversibly anonymized. But you have to keep in mind that by introducing “randomness” into the dataset, you limit it’s usefulness to check to make sure the statistics match up with the study’s official topline results.

Furthermore, the FDA submission dataset is essentially a database with dozens of tables each with often hundreds of columns. It’s a LOT of data, with exponential complexity to make sure all the right fields are redacted. There’s also the point that pharma companies are under no obligation to release this data. It’s generally considered proprietary. That said, due to the substantial amount of government funding provided to the development of the vaccine, I think we should be entitled to this information.

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

#208

Post by rsfern »

guywhocodes wrote: post #187
fabian2k wrote: post #91

Earlier quoted context omitted.

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.

But we have a similar noise in COVID death and injury as we have incentivized hospitals to register everything and everyone as COVID related. And I believe we all know just about any PCR test can be made positive if you use enough cycles. Sorry but I can't distrust VAERS and then trust the COVID injection complication data added by the same people but now with financial incentives.

You shouldn’t distrust VAERS per se, but it’s purpose is not risk assessment. It’s purpose is surfacing rare side effects for further study.

You don’t have to trust the drug co’s for that, we also have vaccine safety datalink system; so far the only notable side effect of the mRNA vaccines has been the myocarditis in younger people.

https://pubmed.ncbi.nlm.nih.gov/34477809/

Also your point about PCR testing is not accurate.

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

#209

Post by fsociety999 »

dragonwriter wrote: post #184
fsociety999 wrote: post #177

Earlier quoted context omitted.

I understand that, my point is that as part of the EUA, patients are required by law to receive information about the treatment. See section e-1-A-ii here: https://www.law.cornell.edu/uscode/text/21/360bbb-3 (ii)Appropriate conditions designed to ensure that individuals to whom the product is administered are informed— (I)that the Secretary has authorized the emergency use of the product; (II)of the significant known…

> So I am saying, what percentage of people who got the shot actually received this information? That's very different than what you said before, and all of them who got it under the EUA. > Since the trials are ongoing The trials being ongoing is immaterial, it's required when under an EUA, not when the intervention is one for which trials are ongoing, which are different things .

> That's very different than what you said before

Well, it is what I _meant_ and what I believe the op meant that you originally responded to.

> The trials being ongoing is immaterial

No, it is not immaterial, because people have to be notified of “the significant known and potential benefits and risks of such use, and of the extent to which such benefits and risks are unknown”. The fact that the clinical trial is ongoing means that many of those benefits and risks are, in fact, unknown.

You can spin this however you like, but my point is that most people who are receiving and have received shots have NO IDEA that clinical trials are ongoing and the actual data has not been made available to the public (even to their doctors who are likely recommending it). This is the reality whether you would like to believe it or not.

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

#210

Post by nextos »

wombatpm wrote: post #198
nextos wrote: post #189

Earlier quoted context omitted.

Of course patients need to agree. It's actually even simpler. When you recruit patients into a study they sign an agreement that is broad and usually includes data sharing terms. Properly anonymized, of course. Said agreements have previously gone through ethics committees which tend to be extremely strict. They are rarely changed afterwards, since this requires agreement of patients, which is impractical to obtain i…

A broad agreement will most likely NOT make it past the institution review board. Any experiment with human subjects has strict rules around consent and data sharing agreements. The legal exposure is huge.

Broad meaning sequencing data (e.g. RNA) from tissues will be made available in public repositories, and accessible via application to committee.

I have had helped draft at least 6 studies with materials coming from our own clinical trials and deposited all data myself. Went through institution review boards without an issue, just like many other equivalent studies.

Perhaps your experience is different because of location? I'm referring to EU.

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