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

bmj.com

251–257 of 257 posts

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

#251
post #236

Ummm… no. In IRB applications and informed consent documents you have to be very clear and specific about who you might share their data with under what circumstances. And these documents tend to be legally binding. So this editorial is kind of nutty. To give you an idea, this is kind of like asking banks to release customer account data to the public.

IRBs implement the law. Here in the Netherlands the law specifically has exceptions for releasing data if it's in the interest of public health. It's weighed against other concerns of course but it's not impossible

I fail to see what benefits there are here.

Are citizen biostatisticians going to verify the data and post about how everything checks out? That is quite naive seeing how the data from VAERS is being presented totally out of context in intellectually dishonest ways. Aside: the big problem with VAERS is that you do not have a denominator. Not to mention reporting biases, and the abysmal quality and assessment value of reports.

Even if you did have some cadre if motivated, ethical citizen biostatisticians any type of post hoc analysis would be suspect and epistemologically weaker than the original statistical analysis because it would have been designed with prior knowledge of the data.

Compare to the original study where the statistical analysis plan was prospectively designed and publicly disclosed BEFORE any patient enrollment or data collection.

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

#252
post #250

Earlier quoted context omitted.

Considering that BMJ made an entire article objecting to FB fact checking BMJ for public audiences [0], I really have to disagree that the article was only meant for expert eyes. Given that, a few disclaimers and limitations to help quell public misinterpretation is required. Not to do so is irresponsible. [0]: https://www.bmj.com/content/376/bmj.o95

I really don't think the objection (and reasons for the objection) to the fact check (1) and the intended audience being largely composed of experts (2) are mutually exclusive.

There should be 0 problem with not being able to share publicly if it was not meant for public audiences. They really can only have one or the other. Experts can email each other.

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

#253

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…

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.

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

#254
post #205

Earlier quoted context omitted.

> 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 d…

For me it took 6 months before the pain was reduced to "infrequent", I'm back to exercising almost to the full extent now as I was in July. I received a diagnosis of pericarditis and had persistent tachycardia, mildest strain and my heart rate would shoot to 170 BPM not going below 85 while lying down. Now I'm back to normal and my resting heart rate is now 50-55 BPM.

Despite large population and supposedly lots of data, CDC was very slow to notice this.

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

#255

Earlier quoted context omitted.

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,…

If the point is to improve public trust “don’t worry, we manipulated the data to make it more anonymous, but we pinky swear that we didn’t manipulate it in a way that changes the results” is not a good approach.

It is when it's mathematically robust by design, as in the linked post.

Nobody's saying "tamper with the evidence to demonstrate favourable outcomes" here.

And if tampering with the data to favour the data donor were a concern in the first place, then it should be a concern regardless of whether the data donor said they followed further anonymization protocols or not.

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

#256

Earlier quoted context omitted.

If the point is to improve public trust “don’t worry, we manipulated the data to make it more anonymous, but we pinky swear that we didn’t manipulate it in a way that changes the results” is not a good approach.

It is when it's mathematically robust by design, as in the linked post. Nobody's saying "tamper with the evidence to demonstrate favourable outcomes" here. And if tampering with the data to favour the data donor were a concern in the first place, then it should be a concern regardless of whether the data donor said they followed further anonymization protocols or not.

> Nobody's saying "tamper with the evidence to demonstrate favourable outcomes" here.

Yeah, so you have badly misread my point, and you're arguing against something completely unrelated to what I'm saying.

Of course you can add randomness to the results to hide individuals without messing with the results in aggregate. That's obvious, and I'm not disputing it. The issue is that that's a PR nightmare. Nobody here might be saying "tamper with it to change the outcome", but I guarantee you that people out wider media will accuse the CDC and Pfizer of doing exactly that. I can see the chyron now, "CDC ADMITS TO MANIPULATING DATA".

Organizations like the CDC need to think not just about how their message will be heard, but how it might be twisted and abused by bad faith actors. You are absolutely right about how you can safely introduce randomness, but you are completely wrong about how that will be handled by the public after bad faith actors get their hands on that fact.

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

#257

Earlier quoted context omitted.

It is when it's mathematically robust by design, as in the linked post. Nobody's saying "tamper with the evidence to demonstrate favourable outcomes" here. And if tampering with the data to favour the data donor were a concern in the first place, then it should be a concern regardless of whether the data donor said they followed further anonymization protocols or not.

> Nobody's saying "tamper with the evidence to demonstrate favourable outcomes" here. Yeah, so you have badly misread my point, and you're arguing against something completely unrelated to what I'm saying. Of course you can add randomness to the results to hide individuals without messing with the results in aggregate. That's obvious, and I'm not disputing it. The issue is that that's a PR nightmare. Nobody here migh…

Well now we're completely in the realm of speculation, but, ok, sure.

But I don't necessarily think this would go down much worse than "Big Pharma refuses to share data, what could they be hiding from us" bad faith actors.

At least in the 'inject randomness' scenario you can do some damage control in the media by bringing in experts to explain how this is a valid thing to do and how it protects the average joe from having their lives turned upside down just because they foolishly agreed (or worse, did not agree) to have their data collected.

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