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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

#211

Post by rsfern »

a45a33s wrote: post #119
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…

the covid vaccine trials had no control groups either

They were all doubly blinded placebo controlled trials…

Are you talking about how they unblinded the study after efficacy results started coming in?

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

#212

Post by dragonwriter »

fsociety999 wrote: post #209
dragonwriter wrote: post #184

Earlier quoted context omitted.

> 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 on…

> the clinical trial

This is one of your many points of confusion; it is completely normal for even long approved interventions to have many clinical trials in varying stages. There are currently 92 trials for the Pfizer vaccine listed on clinicaltrials.gov, in stages from “not yet recruiting” to “completed”.

And also 1,761 between “Not Yet Recruiting” and “Active” for the notorious untested drug aspirin.

> many of those benefits and risks are, in fact, unknown

That's kind of expected with an EUA more than a fully approved intervention (but even for the latter it's always the case), and why disclosure of potential unlnown risks is required with EUAs.

You unsupported assertion that this requirement is routinely ignored would be a problem if it was true, but you offer exactly zero reason to believe it is true, surrounded by a lot of irrelevancies that show you don't understand the context.

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

#213

Post by snowwrestler »

rvnx wrote: post #186
bshipp wrote: post #148

Earlier quoted context omitted.

Anonymizing datasets is time consuming and would take resources away from the FDA to implement, instead of doing it themselves. I have no doubt people want to help but the only way they really could would be to sign a contract with someone who is allowed to share that data internally, and operate in a embargoed situation (such as on-premise) under an NDA. Otherwise it's sort of like my 10-year-old wanting to help me…

I think Pfizer got 50B+ USD in revenue in 2021, maybe they can find a little bit of change somewhere to hire specialists to prepare the data cleanly and release it ?

A dataset that Pfizer spends a ton of money redacting before releasing might not address concerns that Pfizer could be hiding something.

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

#214

Post by snowwrestler »

fsociety999 wrote: post #177
dragonwriter wrote: post #166

Earlier quoted context omitted.

> It absolutely is part of an ongoing clinical trial regardless us if it is authorized for emergency use. It is for the people enrolled in an actual clinical trial. It's not for people outside of the clinical trial using it under either the EUA or the subsequent full authorization. > How many people who were given the vaccine were told that it is part of an ongoing clinical trial, 100% of those for whom that was true…

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…

I received a printed handout with every shot I received and my kids received. Are you asking whether every vaccine clinic handed those out as they were required to?

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

#215

Post by [deleted] »

breck wrote: post #191
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…

> 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. I see this position put out there a lot and generally go unchallenged. For the record some people think the opposite: that it was unethical to unblind the placebo group so early. At the time you could estimate that continuing the placebo…

[deleted]

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

#216

Post by geoduck14 »

cogman10 wrote: post #131
throwawaygh wrote: post #114

Earlier quoted context omitted.

> So tell me, what harm have I done to myself by sharing this information? None, and yet you still aren't willing to put your name behind the statement "I'm healthy as a fiddle and never use drugs except the occasional beer". Also -- and this will apparently come as a surprise to you -- people who have STDs, abuse drugs/alcohol, or have genetic disorders in their family don't necessarily want that info shared on the…

Frankly, putting up my name with my medical history has far less to do with having the two linked and far more to do with "I'd rather not have a future employer have an easy link to my social media information". Oh genetic disorders, you didn't ask about that earlier. My family is a carrier for cystic fibrosis. Is that something that's supposed to be super terrible to share? I'm not the GP, but frankly I think it's a…

>I think it's a little crazy how worried everyone is about being identified through round about methods in medical data

Do you realize that people were murdered because of their medical history? Like mental illness and ADD were reasons for killing people in America just a couple of decades ago?

And currently, today there places where it is acceptable to drown your own babies if they demonstrate delayed development. Imagine your village elder coming to you and telling you that your baby needs to go in a bucket of water because he has club feet. That is happening. Today.

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

#217

Post by geoduck14 »

rsfern wrote: post #203
rvnx wrote: post #193

Earlier quoted context omitted.

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...

>I don’t think they are allowed to ask those questions

They are DEFINITELY not allowed to ask.

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

#218

Post by ashtonkem »

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.…

> 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).

Right, and do you believe that a full release of the phase 3 trial data would convince them? I sure don't. Anti-vaxx is a fundamentally anti-expert stance, and most people have not logically convinced themselves into that position. Give them the full data set and I bet 9 out of 10 would ignore it, misinterpret it, read lies about it, or just assume that the data set is fake.

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

#219

Post by soupfordummies »

jacquesm wrote: post #138
notwhereyouare wrote: post #135

Earlier quoted context omitted.

didn't netflix have to stop their algorithm recommendation competition because people were starting to identify real people through the samples provided?

See also: the AOL search CD ROM set and many other releases where it turned out that anonymous data isn't.

I’m intrigued. Got any more info on this or something I can google?

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

#220

Post by noogle »

eminence32 wrote: post #168
invokestatic wrote: post #156

Earlier quoted context omitted.

Under the safe-harbor deidentification guide you posted, all dates must be removed except for the year. If this was done on a clinical trial dataset, the data would be useless. Specifically for the COVID vaccine trial, the “statistic” used is the number of days between when the patient enters the study and when they get COVID. This is called TTE or time-to-event and underpins the entire study design. You need the exa…

Focusing on the date aspect for a minute: is it possible to adjust the data (before the deidentification process) and convert relevant absolute dates into durations? For example, is it possible (and is it useful) to adjust the data so that it says something like "patient abc123 entered the study in 2021 and 83 days after receiving a vaccine they showed started to show symptoms. Symptoms ended 3 days later"

COVID has a strong absolute-calendar trends (variants, waves), so removing the absolute dates might harm the analysis.
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