Covid-19 vaccines and treatments: we must have raw data, now • Hacker News Board

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

#61

Post by gpm » Thu, Jan 20, 2022, 10:29 PM UTC

aeternum wrote: post #48

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…

> 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 (exce…

> 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.

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

#62

Post by [deleted] » Thu, Jan 20, 2022, 10:29 PM UTC

ceejayoz wrote: post #50

walterbell wrote: post #34

Earlier quoted context omitted.

> The government doesn't really have the authority to classify information generated by private entities like Pfizer barring specific legislation. They can classify patents at will.

Yes, and I cited the very specific legislation allowing that.

[deleted]

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

#63

Post by mike_d » Thu, Jan 20, 2022, 10:29 PM UTC

diroussel wrote: post #36

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…

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 the established norm, you know that is worth further investigation.

(Full disclosure: my family used to own a company that ran clinical trials for pharmaceutical companies)

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

#64

Post by walterbell » Thu, Jan 20, 2022, 10:30 PM UTC

ceejayoz wrote: post #50

walterbell wrote: post #34

Earlier quoted context omitted.

> The government doesn't really have the authority to classify information generated by private entities like Pfizer barring specific legislation. They can classify patents at will.

Yes, and I cited the very specific legislation allowing that.

Thanks for the link. My comment was posted before you added the citation.

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

#65

Post by incrudible » Thu, Jan 20, 2022, 10:31 PM UTC

fabian2k wrote: post #44

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…

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 liv…

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.

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

#66

Post by [deleted] » Thu, Jan 20, 2022, 10:32 PM UTC

[deleted]

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

#67

Post by fabian2k » Thu, Jan 20, 2022, 10:36 PM UTC

incrudible wrote: post #65

fabian2k wrote: post #44

Earlier quoted context omitted.

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 liv…

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.

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.

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

#68

Post by drukenemo » Thu, Jan 20, 2022, 10:36 PM UTC

diroussel wrote: post #47

srcreigh wrote: post #31

Earlier quoted context omitted.

Yup. I'm not sure how many non anti vax people who comment in support of BMJ actually read the original article. If you are them please reveal yourself and explain how you found nothing wrong with the original article. Most of these comments in the threads just seem like tired knee jerk anti big media / anti vax memes.

I'm a pro vax person, and I've had three vaccine doses. But I have a few anti-vaxers around in friends and family, and it can be hard to argue with them that vaccines are totally safe and effective for them (not talking about the population as a whole). I would like safe and effective vaccines, and I would like to know that the vaccines I have been administered have really got the backing of truly scientific trials.…

In your definition, an anti-vaxxer is someone who refuses the covid-19 jab or any jab? If it’s the former, I find that quite disingenuous.

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

#69

Post by ceejayoz » Thu, Jan 20, 2022, 10:37 PM UTC

choward wrote: post #30

ceejayoz wrote: post #20

Earlier quoted context omitted.

Quoted post unavailable.

Quoted post unavailable.

> So? That's up to you to determine.

Sure, which is why I find it useful to know about the source, and criticism of their past work, when evaluating an op-ed just published in a field that requires substantial domain knowledge to fairly evaluate claims. I linked an article not very charitable towards the author because I consider it valuable in exactly this sort of determination.

> You don't need an expert to tell you transparency is good.

You don't need an expert to tell you complete transparency can have downsides, especially where patients' medical data is involved.

HN usually takes a dim view of "if you have nothing to hide you have nothing to worry about", but the rapid release of raw medical records is the sort of scenario where people may have lots to hide.

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

#70

Post by mike_d » Thu, Jan 20, 2022, 10:37 PM UTC

fsociety999 wrote: post #39

dragonwriter wrote: post #16

Earlier quoted context omitted.

> Also, how can Pfizer claim that their "study" ends in 2023? Because it does. https://beta.clinicaltrials.gov/study/NCT04848584 > Several hundred million people have already received their vaccine, unaware that it's part of a study Because it's not. Use under the EUA and subsequent approval is separate from and in parallel with continuing studies.

> Because it's not That is misleading at best. It absolutely is part of an ongoing clinical trial regardless us if it is authorized for emergency use. How many people who were given the vaccine were told that it is part of an ongoing clinical trial, authorized for emergency use, and the data from the trial won’t be available for years? I suspect a very small percent.

Trial participants sign agreements to be part of the trial and usually receive compensation or free medical treatment in exchange for being part of the trial and continued health monitoring. This is a hard rule from the FDA, and failure to do so is subject to criminal liability.

Individuals receiving drug under an EUA are not part of a clinical trial, regardless of what you think of the drug.