> After a freedom of information request to the agency for Pfizer’s vaccine data, the FDA offered to release 500 pages a month, a process that would take decades to complete
75 years, actually.
I don't mind trusting what someone says, but I need to be able to verify it.
Yeah, that was absolutely ridiculous. What are they doing, evaluating it pixel by pixel? That's 25 pages a day (20 working days a month), or 3 pages an hour (8 hour day). Does it really take 20 minutes per page to prepare the data for release? Do they really only have one person they can put on the task?
They deserved to have that both mocked and slapped down. It was an insult to both our intelligence and our right to know the truth about what they want us to take.
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.
Surely releasing the trial data is a net positive for all the national populations that have paid for it.
> it can be hard to argue with them that vaccines are totally safe and effective for them
That is especially hard since there is simply no way to know for sure whether the vaccine will be "totally safe and effective for them": https://news.ycombinator.com/item?id=29206892 .
This is my thing as well. I work at vaccine clinics and obviously am onboard with the vaccines, however I still feel bad helping administer these vaccines to people who are hesitant. Because of government vaccine mandates or employer vaccine mandates it has made some people who come in feeling "forced" to get a vaccine. And it honestly does not feel like this is the proper scientific or medical way. It sucks to give someone a vaccine when you know they aren't fully trusting in the science behind it. A lot of people are having to choose whether they put uproot their whole families and lose their jobs, or whether they just go and get the vaccine. They are not technically forced, but it honestly seems like it pretty much is. For me it does not feel morally right to have people who feel forced to make medical decisions they don't agree with without even having access to the raw data that would help indicate it's safe.
And it doesn't help that there have been multiple leaks now regarding companies like Pfizer that have made them appear even more shady. Not to mention Pfizers multiple billion dollar lawsuits/fines in the past. I don't blame some people for being skeptical, nor do I blame them for feeling like they are forced to get something they aren't sure they can trust.
It's hard to just trust an organization that has already done multiple things in the past to make you not want to trust them.
The cases that feel even worse for me are the people who have had previous doses and are coming in for 2nd doses or boosters but have had previous unexplained side effects shortly after the doses. Like side effects that are beyond the "normal" ones. Many of these people have visited hospitals or their family doctors, had multiple tests, and get told that nothing is wrong, or that they are not sure what is wrong. And these kind of cases are often not counted an "adverse effect". I alone have had many people tell me these things. They often again feel forced to get the next dose because of pressure from their employer or government. And it just feels bad giving them the vaccine, because they don't sound anti-vaxx, they sound like they legitimately had a severe reaction to the vaccine. But often doctors and public health agencies will brush these incidents off and pretend like it's not because of the vaccine. They are dismissed and considered an anti-vaxxer making things up. And this really sucks. This is not the way medicine should work.
As far as I can see, in the UK, these adverse effects are not being logged or recorded in such a way that any analysis could be done to determine the scale, or even existence of any problem.
I heard that there was a public database in US for this sort of thing. But it has it’s own problems about data quality.
I'm in Canada and we do have an official way primary care doctors and public health officials and report and have adverse conditions investigated. The problem is that when a patient presents with symptoms that started shortly after the vaccine administration they are often dismissed by their primary physician. Often the doctors even do scans or blood work and they find "nothing" and deem the person being okay. Rather then doing further investigation the patient is often treated like they are making up symptoms or exaggerating. Basically they treat them like an anti-vaxxer instead of properly investigating their condition. They just tell them not to worry "it'll go away".
We have people who come in to get additional doses and they'll mention having some pretty serious symptoms after their last vaccine and we will be so surprised with how often we are told they went to both the hospital and their family doctor and got zero resolution and the doctor did not report it to public health.
In many cases we just seem them medically inelligble in these cases and tell them they need to go to their doctor and followup more to ensure they will be safe to get another dose.
And this is where I think a lot of the problems with vaccine mandates and pressure from employers can lie. You end up with people who feel like they have no choice to get the vaccine, they have a bad reaction to it, and then doctors treat them like they are lying or that it's no big deal. Then they go for their next dose feeling even more untrusting of science and get another vaccine.
We are ruining a lot of people's trust in science and medicine by how hard these things are pushed. Because of how much push back there is against anything negative with vaccines, it means doctors also often end up with this same bias. They are afraid to attribute any problem a patient has to the vaccine.
I have no problem with vaccines and have 3 doses currently. But I can empathize with these people who feel hesitant and I myself definitely have lost some faith over the last year of doing this work.
It really seems like a lot of scientific and medical standards have been tossed out the window because of politics.
The US has multiple such systems that serve different purposes. We have a passive monitoring system (VAERS) that you might be referring to in data quality issue. It’s for identifying side effects for further study, and it’s explicitly but for estimating risk. That doesn’t stop people from publishing studies based on data they try to filter and verify validate from VAERS.
We also have the vaccine safety datalink, which is intended for causal and quantitative studies of the things surfaced in VAERS, etc. it’s based on electronic health record integration across a network of hospitals covering I think about 3% of the US population. It is public as in publicly funded I guess, but not as in public access. You can read the first report here: https://doi.org/10.1001/jama.2021.15072
I am reasonably sure the UK has a similar setup, with some passive monitoring system and a much better health record integration story through NHS.
> 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.
I don’t believe it will convince those that don’t want to be convinced. But I want to be convinced, and I want transparency in the science that my taxes are funding and in the enlightened society in which I wish to live.
Transparency in science should include publishing raw data, as apart from re-creating the statistics in the report there is no other way the trial is repeatable.
That’s moving the goal posts though. Now we’re balancing the privacy of those on the trial against your interest in seeing the data even though you’re already vaccinated. And you yourself don’t think that it would convince anyone that’s antivaxx. I don’t see the social benefit here, other than you’ll feel better.
Furthermore, it’s not obvious full transparency will help. You’re almost certainly not a medical researcher, so it's not clear if you could do anything useful with the full data set. And our experience with VAERS shows that bad faith actors absolutely can and will lie about it. I see absolutely no upside to releasing the full data set, and a lot of downside for those who volunteered for the trials.
I'm a biochemist, and I'm as pro-vaccine as they come. The BMJ is a highly reputable journal.
It's unfortunate that the anti-vaxx idiots are misinterpreting or decontextualizing their content, but that's the anti-vaxx's fault and it's what they've always done.
Would it be so hard to state the limitations of their investigation, and clearly explain that a few key misconceptions are incorrect?
Based on their original censored article, it seems like they're heavily invested to make things seem problematic, and carefully avoid any indication that the status quo is acceptable. I don't think it's purely misinterpretation when anti vax people become generally skeptical of govt and pharma corps.
Like could they not just say the vaccine is safe in these articles based on other evidence? They care about people being able to share their posts to Facebook, I can't understand why they aren't trying even a little to reduce the possibility for public misinterpretation.
They were not putting into question the safety of vaccines, that issue was tangential. I know the article has the literal words "patient safety" and raises potential safety concerns, but that all has to be read in full context: advocating for better data controls and better rigour in research.
It might seem obvious to you that the article would be misinterpreted or parts of it taken out of context by a lay public, but scientific publications are meant to be read mainly by other scientists, and this paper was written with that specific public in mind.
Even if this was intended as official public health communication, which it wasn't, public health communication is an absolute nightmare of a minefield. There's absolutely nothing you can ever say that won't be misinterpreted or misunderstood by some people, and the game is all about minimizing the potential for that. It's easier said than done. (And again, this paper was meant to be shared among expert colleagues in the field.)
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.
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.
I cannot recommend that article. Science exists in a realm of science, just because a major medical organisation is misunderstood dosen't make them 'antivaxxers'. BMJ is asking for open data, something I think many people here could utilise and find value in.
What does this mean? That article is very specific, and is not sensational. He's been complaining about the BMJ for some time, and not just about these vaccines.
edit: open data is fine and good. The BMJ demanding it here is intentional sensationalism and part of a continuing pattern.
Incidentally, emember that antivax wasn't even a thing until The Lancet unleashed it on the world. Journals are often badly behaved in order to make headlines.
> Indeed, Doshi has history of playing footsie with the antivaccine movement, amplifying antivaccine conspiracy theories, downplaying the severity of influenza and thus feeding antivaccine narratives, using sleight-of-hand to downplay the effectiveness of flu vaccines, and generally playing the role of a false skeptic with respect to vaccines. At this point, I can’t help but note that Doshi also once signed a petition “questioning” whether HIV causes AIDS.
I'm so sick of comments like this. I'll read the goddamn information presented to me and use my own critical thinking skills to determine what I see as useful. Whatever past the person has, if there is a potential issue with something, it's someone like this who has been paying attention with a focus on the matter who will alert us first.
Please don't cross into snark and attack like that. It adds poison to the ecosystem and weakens your argument. More explanation here: https://news.ycombinator.com/item?id=30016018.
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.
The chairman of Thompson Reuters, who professionally fact check information for Facebook, is on the board of Pfizer which is a grave conflict of interest and there's been repeated examples of them lying outright so all bets are off on who you may suggest is being misleading.
So you think that all studies AND hospitalization data that show the benefit of the vaccines now that billions of people are vaccinated are... FALSE... across hundreds of countries... because the chairman of ONE news organization is on the board of Pfizer?
I appreciate how antivax people love to share this fact like this is the ULTIMATE argument as to why the vaccine is actually BAD.
its really hard to ignore the persons character, but not addressing the argument (and instead talking about the persons character) is a logical fallacy.
We've banned this account for repeatedly breaking the site guidelines.
Crossing into personal attack and snark, besides being against HN's rules, has the effect of discrediting your own point of view. That is a poor trade to make in exchange for a momentary bit of venting. Not only that, but if your view happens to actually be correct, then it has the side effect of discrediting the truth, which is not in any of our interests. https://hn.algolia.com/?dateRange=all&page=0&prefix=true&sor...
Can you please not create accounts to break the HN guidelines with?
I love how people attack the character of anyone who says anything even remotely against the pharmaceutical industry and their narratives. They like to find some sort of evidence that they are one of those "anti-vaxxers" and think that discredits them. Now they don't have to debate anything.
How about you argue with the points made in the article? Do you disagree with anything in the article? Is their dreaded "misinformation" in it. If so point it out and ideally provide some evidence.
I am pro transparency especially when it comes to a global pandemic. I've always been that way. I'm not going to change my opinion because some other person has the same opinion. I don't give a rats ass who wrote the article. It could have been Santa Claus. I like to read articles and do my own research and form my own opinions. People like you who want to try to discredit people so you can silence debate are the biggest problem in this pandemic.
Oh, and you know who else got AIDS and HIV completely wrong? Dr. Fauci.
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, medical history, etc.
As a patient, I’d hope my healthcare worker is interested in both my privacy and not giving me communicable diseases.
Most real world scenarios involve rights that may conflict at times, like the right to free speech running into libel. As a society, we wind up having to decide how to resolve those conflicts.
We started down this thread with you asking people to argue with the points of the article, not with who the author was.
Now here you are, asking ceejayoz loaded question after loaded question. You sure look like you're trying to find some reason to dismiss what he says. That's not cool, especially since you started us down the "discuss the actual points" path.
How are the questions loaded? They are relevant in making my point. In order to have debate you need information. If there's no transparency debate becomes pointless. The debate just comes from to who you trust and not real data.
ceejayoz said they're pro medical privacy but thinks that people should have to let people know if they're vaccinated. It makes no sense.
They also want people to be fired from their jobs for not taking a vaccine whose data isn't being released.
In summary I find it hypocritical to be against vaccine transparency but for mandates. It's also hypocritical to be for medical privacy but be for vaccine mandates.
I am for privacy and against mandates. Especially against mandates as currently implemented. I just think that it is not overly hypocritical to take a pro-privacy and pro-mandate position at the same. These positions can co-exist. See https://news.ycombinator.com/item?id=29401254.
Mandate does not need to include public display of compliance at irrelevant points. The current implementation seems to be driven by assumption that many could be shamed into compliance. I believe it is very misguided policy, which works in a completely opposite way with people it aimed upon. Also, believe it or not, many people technically compliant are at the same time pretty disgusted with the privacy-breaking aspect.
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.
There's no need at all for some kind of organized conspiracy, just the typical shoddy work covered for by similarly interested parties. I am not saying that's what happened in this case, but it's not exactly rare. The life sciences are absolutely rife with bad work - even notorious Covid research, for example, many of the computer-model based research, which was only exposed because regular everyday computer programmers looked at it after it was published - and often their criticisms led to coverups and denial!
Conspiracy theorists usually do go nuts with this stuff, but usually there's no need for an organized "conspiracy" when class or professional interests are at stake.
For example, that's one very clearly stated reason why US government officials running scientific agencies shut down scientific discussion of the lab leak theory, and why most scientists went along with it: because of the risk that the public backlash might harm their funding - the same sort of backlash that led to restrictions on gain-of-function research in the first place, that they ended up working around.
> ‘I share your view that a swift convening of experts in a confidence inspiring framework (WHO seems really the only option) is needed, or the voices of conspiracy will quickly dominate, doing great potential harm to science and international harmony…’”
People quite naturally and regularly act in a way that appears coordinated without any actual coordination.
Many of the accusations in this allegedly science-based article are purely guilt by association. In many cases there's no association at all, just fringe people referencing Doshi's peer-reviewed publications. If Hitler was against cigarettes, does that mean I should smoke? I can literally not find two consecutive sentences in this entire article without a snarky ad hominem or tribal flag-wave.
It seems there has to be some amendments to rules about releasing raw, anonymized trial data when the state is sponsoring development of the drug.
Also, how can Pfizer claim that their "study" ends in 2023? Several hundred million people have already received their vaccine, unaware that it's part of a study where the clinical data is not even accessible to their doctors...
> Also, how can Pfizer claim that their "study" ends in 2023?
Long-term studies are common. We still study Tylenol to this day, for example, to monitor for things like "does it interact with newly approved drugs".
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.
My kids were in a clinical trial on bilirubin lights, a technology around since the 1950s. Would it be fair to imply the lights are untested as a result?
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.
(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 and potential benefits and risks of such use, and of the extent to which such benefits and risks are unknown; and
(III)of the option to accept or refuse administration of the product, of the consequences, if any, of refusing administration of the product, and of the alternatives to the product that are available and of their benefits and risks.
So I am saying, what percentage of people who got the shot actually received this information? Since the trials are ongoing, that should have been communicated to 100% of people who received the vaccine as part of informed consent.
> 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.
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.
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.
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?
>The BMJ supports vaccination policies based on sound evidence. As the global vaccine rollout continues, it cannot be justifiable or in the best interests of patients and the public that we are left to just trust “in the system,” with the distant hope that the underlying data may become available for independent scrutiny at some point in the future. The same applies to treatments for covid-19. Transparency is the key to building trust and an important route to answering people’s legitimate questions about the efficacy and safety of vaccines and treatments and the clinical and public health policies established for their use.
Serious question: if the raw data could potentially undermine public trust in the US government, can it be classified as a matter of national security?
Yes, and there have been bad actors in the government who do that to try and avoid accountability. Hopefully they usually get overruled by someone with good sense in the executive branch. But if not, the judicial branch could overrule an invalid classification and order it be made public.
> Serious question: if the raw data could potentially undermine public trust in the US government, can it be classified as a matter of national security?
No, probably not. The government doesn't really have the authority to classify information generated by private entities like Pfizer barring specific legislation.
> The government doesn't really have the authority to classify information generated by private entities
Pfizer is a defense contractor. It is pretty standard boilerplate that when you receive DoD funds the government can restrict access to information, even unrelated to the products or research directly attributable to that funding.
Not to say that I think the government would actually do that, just that they could.
Why not? Any mistake or design flaw in the trials reduces their value, it doesn't completely eliminate it.
The mistake in the AZ trial is something I consider extremely embarassing and stupid (assuming the published information about it is correct). It's the kind of mistake nobody that actually works in a lab should make, and I really question the competency of the people involved here. But in the end this meant that a part of the study got a half-dose of the vaccine. That makes the interpretation a bit more difficult, but it does not invalidate the trial.
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 publish more raw data. 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 as possible to other scientists.
The (small) controlled trial data can be combined with the (large) uncontrolled mass-population data, e.g. one can look at the larger dataset for corroboration of weak signals in the smaller dataset.
New controlled trials can be started, where further evidence is needed.
Speculation is made either way without datapoints. What's the harm in being transparent if at worst some spurious (but provably spurious) correlations mislead a few people already prone to mistrust? Higher transparency would also dissolve a lot of the claims that the pharmaceutical companies are "hiding" something regarding the actual effectiveness of their vaccines and therapeutics.
I don’t think people claiming pharma companies are going to be satisfied by data dumps. They will simply claim the data are fabricated.
There is so little correspondence between reality and claims already- I think you’re making the mistake that the discourse is in good faith. It doesn’t seem to be to me.
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 doesn't always give that trust and confidence.
(I hope I got my medical terminology right, I'm not a clinician, but have been close to covid-19 related medical research)
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 lives, so I don't think this is something to complain about. It's still possible to do a lot of good science now, even randomized controlled trials. They just can't compare to unvaccinated groups, but you can still do stuff like compare double-vaccinated with triple vaccinated.
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.
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.
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.
> And raw infection counts are not an answer here as the vaccinated and unvaccinated people are clearly not matched populations you can compare...
That's the point! That's why we need controlled trials. With an unvaccinated group. You know, the thing that you say we can't have, because it's unethical.
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.
> 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.
You could easily find millions of potential study participants who don’t want the vaccine. The study wouldn’t be double-blind, but it would be single-blind and better than what they chose to do.
> 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 group might lead to ~60 unnecessary deaths from Covid-19 and a few hundred more serious cases. That is in the lucky scenario where the early success held. But in all scenarios, in return for a few dozen volunteers risking their lives, billions of people would benefit from randomized, placebo-controlled trial data which the NIH itself calls the "gold standard" as to "whether or not a treatment is safe and effective".
IMO the harms we have gone through from flying in the dark (people underhyping/overhyping the vaccines), multiplied by the number of people involved, make this a case where unblinding was unethical. It is very easy to imagine that far more life was lost in the general population from being in the dark than was saved by unblinding the volunteer study population.
(There's also the issue of whether or not it would have been practical to keep the participants blinded. I think that's a challenging topic of its own orthogonal to the ethical question.)
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)
> 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.
> 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 (except for in a well-protected lookup file with highly restricted access).
Making scientific data accessible only to other scientists is highly anti-scientific. Feynman, one of the greatest scientists of all time has many quotes around exactly this mindset:
"Have no respect whatsoever for authority; forget who said it and instead look at what he starts with, where he ends up, and ask yourself, 'Is it reasonable?' ... we will doom humanity for a long time to the chains of authority, confined to the limits of our present imagination. It has been done so many times before."
"Science is the belief in the ignorance of experts"
"Our freedom to doubt was born out of a struggle against authority in the early days of science. It was a very deep and strong struggle: permit us to question - to doubt - to not be sure. I think that it is important that we do not forget this struggle and thus perhaps lose what we have gained."
I'm not fully up to speed with all the research here, but as far as I understand it's quite easy to de-anonymize many datasets of exactly the kind you describe. If you're not really, really careful there will be lots of information in simple demographic data that could easily be matched to other data sources.
> 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.
I think HIPAA is something we should be re-evaluating as a nation. Back in '96 it was certainly a good idea given how devastating things like an HIV diagnosis could be for a family member in a fundamentalist family. Or the impact of said diagnosis on insurance coverage.
With the ACA, the insurance coverage problem is gone. Pre-existing conditions can't be used as a reason to deny or change insurance rates.
The Fundamentalist problem exists, but seems like much less of an issue with LGBT acceptance being so much better now than it was in the 90s.
I just don't think that health information is so valuable that guarding it like a state secret is warranted. I'm ok with the notion of putting in basic safeguards like not attaching a patient name with the information but I don't see it has horrible if some system can infer absolute identity from that stuff.
After all, seems far more scary that my web browsing generates a far clearer picture of who I am than what you could glean from my medical records.
Having health information public and easy to gather would (potentially) be a significant boon to the study of health information. It would also make it a lot easier for us to make health information sharing systems so you don't have to fill out the same 500 forms every time you go to a different hospital or doctor.
Assuming name isn't attached to the data, that'd require the spouse (or someone else) to do the legwork to link up the medical history.
When I say re-evaluate HIPAA, I don't mean "Hey, let's put everyone's name right next to every checkup and list it in a wikipedia like DB and email relatives about the results of every checkup". I mean "Hey, let's consider limiting the scope of the law and the penalties associated with it". It doesn't have to be a black and white thing.
That all seems like a worthy risk if it enables researchers to find that "Hey, looks like people prescribed medication X with medication Y tend to develop cancer Z way more frequently than the general public" or "Hey, looks like people with gene X respond way better to cancer treatment Y than the general public".
Exact dates and exact hospitals should also not be included. Doctors do not manually write their hospital location and the date in each of their notes (instead these are fields added by software like Epic) so this should be easy to just not export those fields.
There will also be some risk that someone has a very unique combination of visits or treatments that does make them identifiable but that should be an incredibly low percentage and we need to weigh the pros/cons. I can also get a good idea of who has cancer by sitting on a bench outside a cancer center and watching who goes in.
Anonymization is difficult and sometimes impossible because reidentification attacks are extremely difficult to prevent. Anonymization is much more complex than people typically assume; see [1,2] for surveys.
The more data you release, the more difficult it is to ensure that subjects cannot be reidentified by combining the "anonymized" dataset with other publicly available data.
Important note: It's not just a case of putting in the work and being willing to share. There are impossibility results in this space. That is, there are reasonable formal threat models for which it is mathematically impossible to release any version of the dataset that is (a) useful (ie contains enough data to replicate findings) and (b) not subject to unacceptable levels of reidentification.
I am generally in favor of releasing data and code/spreadsheets, but anything involving patients becomes difficult quickly. There are also reasonable middle grounds between "no access for anyone" and "throw it in a public s3 bucket". E.g., making data more available to researchers and medical practitioners -- or even sufficiently interested & motivated members of the public -- but under strict data handling rules, enforceable audit trails, and legal consequences for being reckless with sensitive patient data.
Hell, odds are better than even that your employer made you sign a document that would allow them to sue you into oblivion for forwarding some sure-to-be-doomed product launch draft to the wrong person. Being at least that careful with fine-grained medical data on hundreds/thousands of patients isn't exactly unreasonable...
Drawing a hard line on 100% complete, anonymous, and consequence-free access to troves of patient data isn't a reasonable position.
Simply removing the name isn't enough to anonymize the data, because as another commenter noted, the data submitted includes detailed patient histories and information about all of their other conditions, which is more than enough to uniquely identify someone.
And you can't simply strip out that data, because a lot of the subsequent analysis of effectiveness is dependent on it.
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 account for how common the side-effects really are. The most common way to report side-effects (VAERS, and similar national databases) are dismissed due to the self-reporting nature, local GPs frequently dismiss side-effects and tell people to just go home and take a Panadol with zero reporting going on (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"), etc.
Likewise, when it comes to vaccine effectiveness, there are a million and one confounding variables from % of the population that already had natural immunity, covid variants, health, age, seasonality, societal lockdowns, isolation, etc.
Also, it's important I think for us to raise the bar to the highest possible standard when you're talking about a medical intervention that was forced under significant duress (loss of job, social stigma, public/medical shaming) on a substantial percentage of the world's population. We should not be content as a society to come within inches of worldwide medical authoritarianism without asking some seriously hard fucking questions and imposing the absolute strictest and highest possible scientific standards to justify why.
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.
We have high-quality data on the vaccines and their side effects. We don't have RCTs with billions of people, but that is data we never had for anything and can't reasonably get.
Judging the risk/benefit ratio is the primary purpose of the regulatory agencies that approve vaccines. I don't see any reason to believe the claim that the vaccines are harmful for everyone below 50, that sounds quite outrageous to me. There have been adjustments based on new data for the vaccines a few times, e.g. younger people are generally recommended to be vaccinated with Biontech and not Moderna or AZ based on the side effects of these vaccines. That doesn't mean the risk/benefit ratio is bad there, it only means that we have vaccines with a more favorable profile for those age groups.
Exactly. They DID make adjustments to not give Moderna/AstraZeneca to younger people because they had the side effect data and compared it to the risk of getting COVID and realized that Pfizer was probably better at mitigating those risks
Another clear case of someone implying totally crazy things (younger folks without the vaccine would have been better without the vaccine) with absolutely NOTHING to support it.
.. If only we had clear data to make such a decision.
However, collecting and analyzing that data would likely have eaten a percent or two into the eighty billion dollars Pfizer made last year, so I guess there's nothing we can do but trust the same authorities that brought us 'natural origin for sure', 'masks don't work', 'NNVTs don't mean anything any more', and 'Covid isn't airborne'.
Why do you mix mandates and lockdowns in there? What does it have to do with the vaccine?
If you bring lockdowns into the picture, you have to compare to what would have happened WITHOUT a lockdown as well, how many more deaths in hospitals, etc. The countries that tried this strategy have a very high excess death to compared to those that tried to limit human contacts (especially PRE vaccine).
"If we properly match the populations," - that's a big if though. Without any matching, vaccines appear to have negative value because older people are more likely to get vaccinated, but even controlling for age there are a variety of potential confounding variables like general health, risk-avoidance, etc.
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.
> Also your point about PCR testing is not accurate.
Source on that? Because all graphs I've seen show impossible to miss fluorescence around 35 cycles and up.
AFAICT VSD only does specific research at their own behest and currently don't have a section on COVID-19 vaccines.
Btw your link is dead.
I had pericarditis and some immediate reaction, my cardiologist thinks it was partially intravenously applied. Looking at the data on severe reactions from where I live I've been able to obviously tell that CDC must have used incredible criteria for their numbers. At least initially, I stopped caring when it eventually became clear to me that we do not really want to know how many are harmed.
And from the perspective of everyone involved I understand it, I too want this to be over, I too want this to be a safe magic bullet. But seems to me somewhere between 1:1000-10000 have significant heart issues from the Pfizer vaccine, but when we were rolling it out the numbers were claimed to be 1 in 230M.
I’m not going to argue that the US seemed to take longer and have worse communication about the myo/pericarditis issue than some other countries, but these things are being followed up on. The absolute timing I think is hard to discuss with a definite time frame
> 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.
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.
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.
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.
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.
The troubling result is that vaccines have been forced upon [majority] of the people to whom it has no public interest effect - the existing covid vaccines (except SinoVac for which there is no reliable data) don't reduce the spread nor affect hospitalization rate for most as the most have close to 0 chances of hospitalization to start with.
When it comes to spread the vaccines may be even making the situation worse as the infected vaccinated people spread virus at the same level as infected unvaccinated while having less symptoms for the vaccinated means higher chances of them walking around spreading it.
>there were very troubling results from the clinical trials that were swept under the rug
this is why the clinical trials aren't going to conclude until few years down the road as operating under EUA is basically get-out-of-jail-free card for the BigPharma here.
There is a tradeoff between an individual’s absolute right to “health secrecy” and advancing treatments. I think the pendulum has swung too far towards privacy.
I disagree, I think we see a lot of condemnation for having had a treatment or not. On the contrary, we should bring privacy back and make health a private issue completely.
I also worked on medical devices and respective
medical advisory boards. Getting people to share their data is just a question away. If you fail at that, I doubt any further inquiry would net any benefit.
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 public were to be able to get this info, I strongly believe there is enough information to re-identify patients. And it’s not as simple as just removing the sensitive medical data because the primary or secondary analyses may be dependent on them.
The fact that you poo-poo this question is telling. Preventing re-identification attacks is incredibly subtle and sometimes impossible. Removing "city and date of birth" is nowhere near sufficient.
> this raw data is already available, but under a loose NDA for commercial partners and researchers...
Yes. It's available to people who have their real identities tied to their access and can be sued into oblivion or possibly even prosecuted for wanton misuse of the data. Surely you see how this is different from throwing it on a public s3 bucket, right?
It looks like from what you are saying that it's an incommensurable effort to anonymize reasonably the dataset (the majority of the risks can be hedge by bucketing, and then there can be subtle deanonymization edge cases but they don't scale).
It reminds me the FDA saying they can't release the COVID-19 documents because reviewing 44'000 documents would take 50 years.
It didn't take 50 years to produce them...
Yes there is some effort needed to anonymize reasonably the data but it's not an impossible task. It's a question of motivation.
Here, clearly, the labs and administration don't really want to put efforts into that.
Presumable FDAs analysis assumed current staffing levels. Going to go out on a limb and assume they’ve got a LOT more people involved in creating docs than in deidentifying docs.
And, yes, I think public data on this sort of stuff is important and should be properly resourced.
I think:
Step 1. ASK PERMISSION before changing the way data is handled.
Step 2. Share full datasets more generously, but still gated by use and handling agreements. This probably means a private citizens without ethics research training and a supporting it dept can’t get a copy and peruse it on their personal laptop, but also that a truly enormous number of researchers would be able to access the data.
The gold standard of a CSV in a public s3 bucket shouldn’t be the enemy of good enough.
I'm not so sure that you should be so sure that there are no databases that such data can be referenced against. Regarding stripping out major identifiers, please note that OP commented that "it's not as simple as just removing the sensitive medical data because the primary or secondary analyses may be dependent on them".
And of course raw data like this could benefit patients, but keeping access to raw data limited also benefits patients. Sure, the data is readily available under a loose NDA, but it's available to people who have explicit knowledge of the requirements around handling sensitive, identifiable data. Average Joe's and Jane's do not have this knowledge, and bad actors just plain don't give a shit.
I mean, it’s not like anonymous datasets haven’t been de-anonymized before[0]. Successfully anonymizing data sets is a hard and subtle process, and it’s way harder than just removing major identifiers like city and birth date. For example age is obviously super important for vaccine and disease studies, and providing an age narrows down someone’s birthdate significantly.
And no, this isn’t under a “loose” NDA. This would be covered by HIPAA, which tends to be un-subtle about violations.
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.
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?
>So tell me, what harm have I done to myself by sharing this information?
You're comfortable sharing it, that's cool! Is your neighbor? Your friend? Your cousin? Should they be obligated to divulge their own medical information just because you're fine divulging yours?
Right, which - perhaps to your point - demonstrates how a seemingly innocuous piece of data left in a dataset could be used to, with relative ease, identify that individual.
First, I'm guessing that what you provided is a lot less than someone would have to provide in a medical trial.
Second, demonstrating your willingness to describe yourself on a public forum is a lot different than someone expecting confidentiality when participating in medical trials. Most people do not have your level of comfort disclosing medical details. Furthermore, if a company were to break that trust, why would anybody participate in medical trials? The harm is not to you, it is to society.
> 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 internet. Shocking, right?!
Apparently pseudonymous internet griping is an essential right but participants in medical trials should -- post-facto -- have their entire medical history shared in a wy that's at significant risk of reidentification.
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 little crazy how worried everyone is about being identified through round about methods in medical data. Google has a far better bead on exactly who I am than any doctor and, frankly, I'm far more worried about that advertising profile than I am about the "what if's" of my medical data being shared between hospitals and doctors (and potentially being leaked).
>... I'm far more worried about that advertising profile than I am about the "what if's" of my medical data...
Again - yours. It's great that you're fine with your data being public, but as is evidenced by the way certain posts in this comment chain are being down/upvoted, clearly many other people share the opposite view and would prefer their data remain private.
Other nations have more open laws about sharing medical data than the US. (I believe Iceland? Greenland? One of those island nations has genetic ancestry data for all citizens).
AFAIK, the world hasn't ended and they aren't living in a dystopia because their medical information is so well documented. On the contrary it has served to stop the spread of genetic disorders and aid in medical research.
Certainly I personally don't have these hangups about privacy. I think it's weird that society has created them. Pre-HIPAA that wasn't the case and it wasn't exactly seen as major breaches of privacy for doctors/nurses to talk relatively openly about diseases their patients had. The sanctimony of medical data is a recent development practically unique to the US.
I'm not advocating that we broadcast to everyone details of every medical checkup. I am, however, saying that we shouldn't have nearly the level of restrictions we have around sharing medical information, particularly between medical institutions doing research.
>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.
> Like mental illness and ADD were reasons for killing people in America just a couple of decades ago?
Citation needed.
You realize a couple of decades ago was 2000, right? The closest I can think of what you might be talking about is the eugenics programs ran up to the early 1960s. Even so, those weren't executions, but rather sterilizations. Barbaric, but not murder.
> And currently, today there places where it is acceptable to drown your own babies if they demonstrate delayed development.
And what part of making health recorders more accessible would influence that one way or another? Do you think it's the fact that heath records are hard to access that protects us from parents murdering their children? How are other nations in the EU managing to not kill all their kids for defects!
> "I'd rather not have a future employer have an easy link to my social media information"
So, to be clear, your right to post random ass thoughts on the internet under a pseudonym is sacred... but it's totally reasonable to RENEGE on EXISTING privacy agreements with real world actual existing real human patients about intimate health records?
Just so long as we're clear about the enormous esteem you hold yourself in and the absolute contempt you have for others' privacy...
I'm genuinely curious - OP has commented about their direct work with pharmaceutical companies on datasets like what we're discussing. Do you have any history of direct work with similar/same datasets yourself?
> So tell me, what harm have I done to myself by sharing this information?
This is irrelevant.
The conditional probability of my willingness to post this information, given your willingness to post this information, is equal to the the probability of my willingness to post this information. P(X) = P(X|Y). This means that just because you are okay with it, I'm not...and additional people being okay with it doesn't change my opinion regardless of harm.
> 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).
> "We are required to measure our progress toward having at least 7% of our workforce be individuals with disabilities. To do this, we must ask applicants and employees if they have a disability or have ever had a disability. Because a person may become disabled at any time, we ask all of our employees to update their information at least every five years.
Identifying yourself as an individual with a disability is voluntary, and we hope that you will choose to do so."
It looks like you are trying to drift the intent and scope of the dataset disclosure.
For example, having the list of symptoms, medications and even (just an imaginary example) pulmonary X-Ray or also on the chest having an open dataset of MRI pictures with the age of the patient, history of diseases would considerably help and there is no way you can link it back unless you know the history of the patient already (but then, what's the issue; none because you already know the information).
Plus if you ask the person about it, I really don't see the problem :|
Yes in theory, there is a possibility that someone has a database somewhere of all the boobs spacing, and can determine approximate lungs size, try to guess what could be the likely owner of a lung picture, etc etc, all of that for what ?
The person who is going to benefit from it, is clearly the COVID-19 researchers, and the end-patient.
> It looks like you are trying to drift the intent and scope of the dataset disclosure.
No. Intent doesn't matter. That's the whole point.
To wit: there's a reason that reidentification attacks are called attacks! No one intends to be hacked, and writing a program that you intend to be secure doesn't imply that the program is in fact secure. So too with anonymization.
> having an open dataset of MRI pictures
But we're not talking about MRI pictures, are we?
OP strongly believes that, in this case, there is enough information to re-identify patients. I agree.
Plan A:
- sit and do nothing "it's impossible to release any data, too bad, we'll never know!"
Plan B:
- "we have a risk that a few % of ppl may be identified if we already know their medical history/details, it's impossible to release any data, too bad!"
Plan C:
- "we remove the biggest identifiers to make sure the majority of the people cannot be reasonably identified, this is going to take a few days or weeks of work but will bring benefits to the overall population and transparency on the treatments"
Why don't you include a step where you ask patients if they're ok with their medical history being put in a public s3 bucket?
I'm fully supportive of the right to pseudonymous speech, but it strikes me that you are in an awfully awkward position of speaking anonymously while demanding that you should have access a trove of patient history without signing any sort of data use agreement and without even the most basic step of getting permission from the people whose patient history you insist on seeing.
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 "Rebecca", nobody knows it's her, except herself, and those to whom she decide to publicly disclose her conditions (e.g. on social networks or to specialists).
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.
The problem is NOT "how do we de-anonymize". That is super easy.
The problem is "how do we de-anonymize IN A WAY THAT LEAVES RESULTS OF RELEVANT STATISTICAL TESTS INVARIANT". Much harder. Remove a bunch of probably non-random points and make any logisitic regression on that dataset return the same result within some delta. There are trivial impossibility theorems. Really, really trivial. "Left as freshman exercise and if you can't some up with an example maybe step back and stop talking about this topic" trivial.
Now, add back consent. "how do we delete a subset of data that is likely not uniformly distributed with respect to risk variables and also de-anonymize the remaining subset of data.... AGAIN, IN A WAY THAT LEAVES RESULTS OF RELEVANT STATISTICAL TESTS INVARIANT". The position is untenable.
And how do you ensure that statistical tests on the original data set are INVARIANT TO THE DE-ANONMYIZATION PROTOCOL WITH RESPECT TO ANY RELEVANT QUERY?
That is WAY harder that it sounds. When you add public disclosure of mismatch between results on public data and private (full) data things are even harder.
Specifically: suppose an independent researcher determines X is true via statistical test Y on the public dataset. Officials must respond, and say "True" or "False".
A small number of queries via this process can be used to infer data that makes re-identification possible. And there will be many more than a small number of queries, including from adversarial agents specifically designing queries to maximize information gain based on previous (public) revelations.
This is a game, in the game theory sense, in which the goal is to exploit the mathematical properties of statistical tests and social dynamics to force public revelations of binary assessments that yield information about individual cells or sets of cells and make re-id possible.
Have you actually studied this stuff, designed de-anonymization protocols, developed re-id threat models, thought about privacy budgets in public disclosure mandates, and at last put your reputation and your customer's privacy on the line when asserting that your statistical methods are resilient against attacks? Or are you just a jawboning know-it-all anonymous coward without any actual experience balancing privacy against public disclosure?
To be honest, all of your posts read like "just stop writing vulnerable software and then there will be no more hackers mmmkay?"
There's no drift, OP stated this clearly in the original post when he wrote: "I strongly believe there is enough information to re-identify patients"
If you were to have access to my MRIs you could almost certainly identify me based on physical characteristics which can be seen in my MRI data which would correlate with data found on social media where I've sometimes generally discussed my medical conditions without going into specifics. There are MRIs for conditions I haven't discussed, in addition to the identifying ones I have.
There are a lot of people with fairly unique medical conditions and body situations (eg: missing a limb, surgical implants). The gap between "I got hurt in this way" and "here's the MRI scans of my body in detail along with other lab notes and other unrelated and possibly extremely embarrassing conditions" is huge
A strict data use agreement signed by a real person with tangible assets and reputation at stake, outlining the acceptable and unacceptable uses of the data and well as appropriate data handling rules.
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 replace an engine in a car. It's important to let him do it so he can learn but it's likely going to take me much longer to on-board him and get him up to speed than if I did it myself.
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 ?
I have deposited datasets with full transcriptome data, which you can use to infer most of the genome in a straightforward manner, from clinical trials. In that case, you simply use off-the-shelf tools to anonymize datasets by flipping lots of SNPs. Additionally, raw data is made accessible only through an ethics committee. Summary counts from transcriptomes are publicly available, though. There are equivalent practices for other biomarkers.
I must say The British Biomedical Journal (BMJ) is really spearheading all transparency efforts. They have been publishing lots of inconvenient truths for many years. For example, they reported some fairly serious conflicts of interest where professors from Oxford are getting huge "consulting" fees from pharma. And they pretty much publish any reasonable letter to the editor. Nature, Science and Cell, on the other hand, are heavily biased.
> This is already a solved problem... raw data is made accessible only through an ethics committee. Summary counts from transcriptomes are publicly available, though.
Right.
1. I'm not sure you understand the extreme position being taken by
rvnx in this thread.
2. Presumably the patients agreed that their transcriptome data could be shared in this way, and you didn't change your data handling post-facto without their consent.
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 in all but tiny studies.
The only exception I can think of is Scandinavia. They have national registries where all census information, plus electronic health records, is available to researchers by default, unless you explicitly opt out. Their philosophy is that this is a negligible reduction in privacy, in exchange for medical progress. I must note said records are not publicly open, you need to apply for access.
As a consequence, Sweden and Denmark have some of the best epidemiological research in the world and they've been able to spot pretty odd correlations (e.g. ibuprofen and male infertility).
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.
> Perhaps your experience is different because of location?
AFAIK this is also possible in the US. Probably more hoops to jump through? I don't know anything about the EU. (But also this discussion is basically totally unrelated to the original article or this thread.)
> having an open dataset of MRI pictures with the age of the patient, history of diseases would considerably help and there is no way you can link it back
Facial recognition works perfectly fine on MRI face renders. You speak awfully confidently about a problem you seem to have very little experience in.
As with cryptography: Anyone can come up with suggestion that they themselves can't find an attack against.
True, true, pictures are even one level higher in terms of difficulty to anonymise right (and that's not even what they are asking, here it's about structured text records).
FYI, high-res face MRI are just pictures of the face.
So yes, if you share the picture of the face of someone, they may find your identity back, but it's not specific to MRI.
Dealing with any medical record that contains pictures of patient you should take additional steps to prevent identification, and face is the most sensitive part of the body as it can be most likely identified.
If tomorrow there are publicly available anonymised close-up pictures of cardiac MRI, it'd be extremely challenging to map them to their real owner with a 100% certainty but the discoveries it could lead to are very exciting (and the same with skin cancer pictures for example, or suspiciouses moles)
I'll just note that I have no problem with all this information being public for health research. I'd take privacy hits all day long in return for better cures, health, and longevity.
Just curious, do you have anything particularly embarrassing to share? Easy to say when everyone on Tinder can’t Google your name and get “alcoholic with herpes”. I would also be open to share if there was tangible benefit today because I’m healthy. But in the future who knows.
didn't netflix have to stop their algorithm recommendation competition because people were starting to identify real people through the samples provided?
Even if you take more care than AOL did in anonymizing your data, the unfortunate reality is that any publication of data increases the knowledge an adversary has at identifying somebody. Anonymizing is more about reducing the chance someone is identified than guaranteeing they never will be. And high dimensional data is particularly hard to do so in a way that retains the data's usefulness.
33 bits is an old defunct blog on this topic, but it has some interesting posts and academic papers if you want to go down the rabbit hole: https://33bits.wordpress.com/about/
What is the specific basis for your belief that patient re-identification is possible? The federal government has provided clear guidance on de-identification which should eliminate that as a serious concern.
Notice that this is a policy document outlining a process, and that one outcome of following that process can be not sharing the data! It's not as simple as "follow these rules and you can share the data". It can also be "follow these rules, which tell you not to share the data".
It's also possible to reach an outcome that the data can be shared but must be de-identified in a way that precludes important statistical tests. Any sparse feature is incredibly powerful for re-id, and combined with other features might be difficult to share without running afoul of de-id best practice. The problem: rare medical conditions that must be accounted for in a statistical study of vaccine side-effects are examples of sparse features. So you can share the dataset, but not in a way that's useful for a non-GIGO statistical study.
The thing is; in practice, how can you re-id someone that has a very rare medical condition if you don't already know that the person has this very rare medical condition ?
"this person is certainly my biology teacher, who shared the fact that she had a rare genetic disorder during our Genetics unit as well as <insert otherwise non-identifiable columns>. She has herpes. Or also she has an alcohol problem and used to do acid." Teacher is now fired.
You also keep ignoring the issue of consent. Step one is to ask patients.
Or the person shared their story on the public website of a "Run For The Cure" style website about that genetic disorder.
Or so on.
"Sparse Features" aren't always a thing that the person wants to keep private.
It's that knowing that someone has a rare medical condition that someone willingly shared can be a signal to find out other things in their medical records that they may not have wanted to share with others they know.
Let's look in practice, as they exist: look at VAERS for example, it's in this exact situation (these are public records posted on a public and non-confidential HTTP server):
This is the type of raw records we are talking about, and they carry useful information.
Yes, maybe the dates could be anonymised better, if I know the age of someone, and I know when he got his vaccine precisely, and when he got his MRI and why he did it, then maybe I can find and connect back the record.
But how likely this attack can be done in practice, and why would you do it to someone who already disclosed part of their records, plus how does it scale ?
However, the benefits are really present, it's not sharing just for the sake of sharing but to bring advance to the global research and knowledge of medicine.
In practice, who is it ?
I don't know, who can know ? Doctors who can tie it to other pieces of information that we don't have...
However, in the meantime, the researchers and doctors who don't have these foreign keys, they can totally do interesting and useful discoveries about drug interactions and vaccine side-effects.
What this boils down to is a set of observable factors being multiplied. Probably millions of people got the shot in August. From them, probably tens of thousands were overweight. From them, hundreds had diabetes. Add a few other factors like rough age and gender and you get to that one person along with all of their medical history. If we are not talking about the entire US but can know the state, for example, the task becomes so much easier.
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 exact date the patient entered the study AND contracted COVID to calculate the TTE value. Without this information, you have no chance of validating the results of the study.
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"
You will know when a patient visits a study site from the deidentified data. At minimum they will have two visits for shots and a follow-up for a blood draw. You'll also know at least their approximate age and sex. Publicly available location trace databases and purchase histories are probably enough to match a lot of the trial participants.
MIT researchers have been able to assign cafeteria bills to individuals with 80% probability. With any identification information as well as timestamps removed. Correlating datasets gets pretty powerful pretty fast. Also, if the data is made public, we are basically betting, that it is not possible to deanonymize in the future. Given the rate of technological development, I’d be very reluctant to make that bet.
I think the level of effort we make as a society on medical privacy is backwards. All health information should be public except in extreme circumstances. Right now, it's almost impossible to get datasets on health data. Imagine if 100% of everyone's data was digitized. The amount of health innovation, lives saved, cures found, is likely to be incredibly large. All the costs that go into trying to comply with HIPPA, could be gone.
I get that some people want to prevent the use of the data for discrimination...just legislate that then.
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, is another story.
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.
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.
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.
> 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.
The public needs the data, so the public need to pay for it. We absolutely can. Yet the FDA says "sorry only 500 pages a month" which means 110 months.
"The Public" also need our institutions to be Denial of Service resistant.
As a number of sanctioned and disbarred lawyers have demonstrated, several groups in the US are quite happy to launch Denial of Service attacks against our institutions.
The easiest way to solve this is "You get <X> pages per month. If you want more than that, bring FDA certified folks to handle the job and pay them from your own coffers."
I don't see the people requesting the data to also be ponying up the money to get the data faster.
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
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.
257 comments
[ 3.7 ms ] story [ 219 ms ] thread75 years, actually.
I don't mind trusting what someone says, but I need to be able to verify it.
They deserved to have that both mocked and slapped down. It was an insult to both our intelligence and our right to know the truth about what they want us to take.
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"
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 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.
Surely releasing the trial data is a net positive for all the national populations that have paid for it.
That is especially hard since there is simply no way to know for sure whether the vaccine will be "totally safe and effective for them": https://news.ycombinator.com/item?id=29206892 .
And it doesn't help that there have been multiple leaks now regarding companies like Pfizer that have made them appear even more shady. Not to mention Pfizers multiple billion dollar lawsuits/fines in the past. I don't blame some people for being skeptical, nor do I blame them for feeling like they are forced to get something they aren't sure they can trust.
It's hard to just trust an organization that has already done multiple things in the past to make you not want to trust them.
The cases that feel even worse for me are the people who have had previous doses and are coming in for 2nd doses or boosters but have had previous unexplained side effects shortly after the doses. Like side effects that are beyond the "normal" ones. Many of these people have visited hospitals or their family doctors, had multiple tests, and get told that nothing is wrong, or that they are not sure what is wrong. And these kind of cases are often not counted an "adverse effect". I alone have had many people tell me these things. They often again feel forced to get the next dose because of pressure from their employer or government. And it just feels bad giving them the vaccine, because they don't sound anti-vaxx, they sound like they legitimately had a severe reaction to the vaccine. But often doctors and public health agencies will brush these incidents off and pretend like it's not because of the vaccine. They are dismissed and considered an anti-vaxxer making things up. And this really sucks. This is not the way medicine should work.
I heard that there was a public database in US for this sort of thing. But it has it’s own problems about data quality.
We have people who come in to get additional doses and they'll mention having some pretty serious symptoms after their last vaccine and we will be so surprised with how often we are told they went to both the hospital and their family doctor and got zero resolution and the doctor did not report it to public health.
In many cases we just seem them medically inelligble in these cases and tell them they need to go to their doctor and followup more to ensure they will be safe to get another dose.
And this is where I think a lot of the problems with vaccine mandates and pressure from employers can lie. You end up with people who feel like they have no choice to get the vaccine, they have a bad reaction to it, and then doctors treat them like they are lying or that it's no big deal. Then they go for their next dose feeling even more untrusting of science and get another vaccine.
We are ruining a lot of people's trust in science and medicine by how hard these things are pushed. Because of how much push back there is against anything negative with vaccines, it means doctors also often end up with this same bias. They are afraid to attribute any problem a patient has to the vaccine.
I have no problem with vaccines and have 3 doses currently. But I can empathize with these people who feel hesitant and I myself definitely have lost some faith over the last year of doing this work.
It really seems like a lot of scientific and medical standards have been tossed out the window because of politics.
We also have the vaccine safety datalink, which is intended for causal and quantitative studies of the things surfaced in VAERS, etc. it’s based on electronic health record integration across a network of hospitals covering I think about 3% of the US population. It is public as in publicly funded I guess, but not as in public access. You can read the first report here: https://doi.org/10.1001/jama.2021.15072
I am reasonably sure the UK has a similar setup, with some passive monitoring system and a much better health record integration story through NHS.
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.
Transparency in science should include publishing raw data, as apart from re-creating the statistics in the report there is no other way the trial is repeatable.
Furthermore, it’s not obvious full transparency will help. You’re almost certainly not a medical researcher, so it's not clear if you could do anything useful with the full data set. And our experience with VAERS shows that bad faith actors absolutely can and will lie about it. I see absolutely no upside to releasing the full data set, and a lot of downside for those who volunteered for the trials.
It's unfortunate that the anti-vaxx idiots are misinterpreting or decontextualizing their content, but that's the anti-vaxx's fault and it's what they've always done.
Based on their original censored article, it seems like they're heavily invested to make things seem problematic, and carefully avoid any indication that the status quo is acceptable. I don't think it's purely misinterpretation when anti vax people become generally skeptical of govt and pharma corps.
Like could they not just say the vaccine is safe in these articles based on other evidence? They care about people being able to share their posts to Facebook, I can't understand why they aren't trying even a little to reduce the possibility for public misinterpretation.
It might seem obvious to you that the article would be misinterpreted or parts of it taken out of context by a lay public, but scientific publications are meant to be read mainly by other scientists, and this paper was written with that specific public in mind.
Even if this was intended as official public health communication, which it wasn't, public health communication is an absolute nightmare of a minefield. There's absolutely nothing you can ever say that won't be misinterpreted or misunderstood by some people, and the game is all about minimizing the potential for that. It's easier said than done. (And again, this paper was meant to be shared among expert colleagues in the field.)
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
What does this mean? That article is very specific, and is not sensational. He's been complaining about the BMJ for some time, and not just about these vaccines.
edit: open data is fine and good. The BMJ demanding it here is intentional sensationalism and part of a continuing pattern.
Incidentally, emember that antivax wasn't even a thing until The Lancet unleashed it on the world. Journals are often badly behaved in order to make headlines.
> Indeed, Doshi has history of playing footsie with the antivaccine movement, amplifying antivaccine conspiracy theories, downplaying the severity of influenza and thus feeding antivaccine narratives, using sleight-of-hand to downplay the effectiveness of flu vaccines, and generally playing the role of a false skeptic with respect to vaccines. At this point, I can’t help but note that Doshi also once signed a petition “questioning” whether HIV causes AIDS.
That question applies in literally every case and therefore doesn't change change the optimal strategy.
> What if it requires some domain expertise to detect a reasonable-sounding, but actually false claim?
That question applies just as much to links from "sciencebasedmedicine.org" as it does to the OP.
Sure, which is why being aware of both is valuable.
If you wouldn't mind reviewing https://news.ycombinator.com/newsguidelines.html and taking the intended spirit of the site more to heart, we'd be grateful.
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.
I appreciate how antivax people love to share this fact like this is the ULTIMATE argument as to why the vaccine is actually BAD.
Crossing into personal attack and snark, besides being against HN's rules, has the effect of discrediting your own point of view. That is a poor trade to make in exchange for a momentary bit of venting. Not only that, but if your view happens to actually be correct, then it has the side effect of discrediting the truth, which is not in any of our interests. https://hn.algolia.com/?dateRange=all&page=0&prefix=true&sor...
Can you please not create accounts to break the HN guidelines with?
https://news.ycombinator.com/newsguidelines.html
How about you argue with the points made in the article? Do you disagree with anything in the article? Is their dreaded "misinformation" in it. If so point it out and ideally provide some evidence.
I am pro transparency especially when it comes to a global pandemic. I've always been that way. I'm not going to change my opinion because some other person has the same opinion. I don't give a rats ass who wrote the article. It could have been Santa Claus. I like to read articles and do my own research and form my own opinions. People like you who want to try to discredit people so you can silence debate are the biggest problem in this pandemic.
Oh, and you know who else got AIDS and HIV completely wrong? Dr. Fauci.
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, medical history, etc.
I unequivocally support it for healthcare workers.
Most real world scenarios involve rights that may conflict at times, like the right to free speech running into libel. As a society, we wind up having to decide how to resolve those conflicts.
Now here you are, asking ceejayoz loaded question after loaded question. You sure look like you're trying to find some reason to dismiss what he says. That's not cool, especially since you started us down the "discuss the actual points" path.
ceejayoz said they're pro medical privacy but thinks that people should have to let people know if they're vaccinated. It makes no sense.
They also want people to be fired from their jobs for not taking a vaccine whose data isn't being released.
In summary I find it hypocritical to be against vaccine transparency but for mandates. It's also hypocritical to be for medical privacy but be for vaccine mandates.
Mandate does not need to include public display of compliance at irrelevant points. The current implementation seems to be driven by assumption that many could be shamed into compliance. I believe it is very misguided policy, which works in a completely opposite way with people it aimed upon. Also, believe it or not, many people technically compliant are at the same time pretty disgusted with the privacy-breaking aspect.
Privacy matters, you don't just get to look at people's health data for free or without caveats and conditions, namely their consent.
Conspiracy theorists usually do go nuts with this stuff, but usually there's no need for an organized "conspiracy" when class or professional interests are at stake.
For example, that's one very clearly stated reason why US government officials running scientific agencies shut down scientific discussion of the lab leak theory, and why most scientists went along with it: because of the risk that the public backlash might harm their funding - the same sort of backlash that led to restrictions on gain-of-function research in the first place, that they ended up working around.
> ‘I share your view that a swift convening of experts in a confidence inspiring framework (WHO seems really the only option) is needed, or the voices of conspiracy will quickly dominate, doing great potential harm to science and international harmony…’”
People quite naturally and regularly act in a way that appears coordinated without any actual coordination.
Long-term studies are common. We still study Tylenol to this day, for example, to monitor for things like "does it interact with newly approved drugs".
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.
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.
Individuals receiving drug under an EUA are not part of a clinical trial, regardless of what you think of the drug.
https://news.ycombinator.com/item?id=30017165
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. Which is a very small percentage of the population who has received it.
> authorized for emergency use
100% of those for whom that was true, who aren't the same people.
See section e-1-A-ii here: https://www.law.cornell.edu/uscode/text/21/360bbb-3
So I am saying, what percentage of people who got the shot actually received this information? Since the trials are ongoing, that should have been communicated to 100% of people who received the vaccine as part of informed consent.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.
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.
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.
Serious question: if the raw data could potentially undermine public trust in the US government, can it be classified as a matter of national security?
No, probably not. The government doesn't really have the authority to classify information generated by private entities like Pfizer barring specific legislation.
The closest you'd likely come is https://en.wikipedia.org/wiki/Invention_Secrecy_Act, but that allows (temporary) suppression of patents, not clinical trial data.
They can classify patents at will.
Pfizer is a defense contractor. It is pretty standard boilerplate that when you receive DoD funds the government can restrict access to information, even unrelated to the products or research directly attributable to that funding.
Not to say that I think the government would actually do that, just that they could.
Two things can be both be true:
- the vaccine is safe and effective
- parts of approach in running studies weren't as good as they should have been
Seems to perhaps apply here too.
The mistake in the AZ trial is something I consider extremely embarassing and stupid (assuming the published information about it is correct). It's the kind of mistake nobody that actually works in a lab should make, and I really question the competency of the people involved here. But in the end this meant that a part of the study got a half-dose of the vaccine. That makes the interpretation a bit more difficult, but it does not invalidate the trial.
I'm all for putting pressure on everyone in Science to publish more raw data. 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 as possible to other scientists.
The (small) controlled trial data can be combined with the (large) uncontrolled mass-population data, e.g. one can look at the larger dataset for corroboration of weak signals in the smaller dataset.
New controlled trials can be started, where further evidence is needed.
i am sure there will be a red herring in all the data that will cash a small enough shadow.
but this jibbering is about dragging science down to the level of far right ignorance, which is the onlymplace concervatives can win.
There is so little correspondence between reality and claims already- I think you’re making the mistake that the discourse is in good faith. It doesn’t seem to be to me.
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 doesn't always give that trust and confidence.
(I hope I got my medical terminology right, I'm not a clinician, but have been close to covid-19 related medical research)
So the moment we knew the vaccines worked, the science got harder. Well, that point also save an enormous amount of lives, so I don't think this is something to complain about. It's still possible to do a lot of good science now, even randomized controlled trials. They just can't compare to unvaccinated groups, but you can still do stuff like compare double-vaccinated with triple vaccinated.
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.
That's the point! That's why we need controlled trials. With an unvaccinated group. You know, the thing that you say we can't have, because it's unethical.
> ...without adjustments.
As usual, there's an XKCD for that:
https://xkcd.com/2560/
You could easily find millions of potential study participants who don’t want the vaccine. The study wouldn’t be double-blind, but it would be single-blind and better than what they chose to do.
> 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 group might lead to ~60 unnecessary deaths from Covid-19 and a few hundred more serious cases. That is in the lucky scenario where the early success held. But in all scenarios, in return for a few dozen volunteers risking their lives, billions of people would benefit from randomized, placebo-controlled trial data which the NIH itself calls the "gold standard" as to "whether or not a treatment is safe and effective".
IMO the harms we have gone through from flying in the dark (people underhyping/overhyping the vaccines), multiplied by the number of people involved, make this a case where unblinding was unethical. It is very easy to imagine that far more life was lost in the general population from being in the dark than was saved by unblinding the volunteer study population.
(There's also the issue of whether or not it would have been practical to keep the participants blinded. I think that's a challenging topic of its own orthogonal to the ethical question.)
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)
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.
Are you talking about how they unblinded the study after efficacy results started coming in?
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 (except for in a well-protected lookup file with highly restricted access).
Making scientific data accessible only to other scientists is highly anti-scientific. Feynman, one of the greatest scientists of all time has many quotes around exactly this mindset:
"Have no respect whatsoever for authority; forget who said it and instead look at what he starts with, where he ends up, and ask yourself, 'Is it reasonable?' ... we will doom humanity for a long time to the chains of authority, confined to the limits of our present imagination. It has been done so many times before."
"Science is the belief in the ignorance of experts"
"Our freedom to doubt was born out of a struggle against authority in the early days of science. It was a very deep and strong struggle: permit us to question - to doubt - to not be sure. I think that it is important that we do not forget this struggle and thus perhaps lose what we have gained."
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.
With the ACA, the insurance coverage problem is gone. Pre-existing conditions can't be used as a reason to deny or change insurance rates.
The Fundamentalist problem exists, but seems like much less of an issue with LGBT acceptance being so much better now than it was in the 90s.
I just don't think that health information is so valuable that guarding it like a state secret is warranted. I'm ok with the notion of putting in basic safeguards like not attaching a patient name with the information but I don't see it has horrible if some system can infer absolute identity from that stuff.
After all, seems far more scary that my web browsing generates a far clearer picture of who I am than what you could glean from my medical records.
Having health information public and easy to gather would (potentially) be a significant boon to the study of health information. It would also make it a lot easier for us to make health information sharing systems so you don't have to fill out the same 500 forms every time you go to a different hospital or doctor.
When I say re-evaluate HIPAA, I don't mean "Hey, let's put everyone's name right next to every checkup and list it in a wikipedia like DB and email relatives about the results of every checkup". I mean "Hey, let's consider limiting the scope of the law and the penalties associated with it". It doesn't have to be a black and white thing.
That all seems like a worthy risk if it enables researchers to find that "Hey, looks like people prescribed medication X with medication Y tend to develop cancer Z way more frequently than the general public" or "Hey, looks like people with gene X respond way better to cancer treatment Y than the general public".
There will also be some risk that someone has a very unique combination of visits or treatments that does make them identifiable but that should be an incredibly low percentage and we need to weigh the pros/cons. I can also get a good idea of who has cancer by sitting on a bench outside a cancer center and watching who goes in.
The more data you release, the more difficult it is to ensure that subjects cannot be reidentified by combining the "anonymized" dataset with other publicly available data.
Important note: It's not just a case of putting in the work and being willing to share. There are impossibility results in this space. That is, there are reasonable formal threat models for which it is mathematically impossible to release any version of the dataset that is (a) useful (ie contains enough data to replicate findings) and (b) not subject to unacceptable levels of reidentification.
I am generally in favor of releasing data and code/spreadsheets, but anything involving patients becomes difficult quickly. There are also reasonable middle grounds between "no access for anyone" and "throw it in a public s3 bucket". E.g., making data more available to researchers and medical practitioners -- or even sufficiently interested & motivated members of the public -- but under strict data handling rules, enforceable audit trails, and legal consequences for being reckless with sensitive patient data.
Hell, odds are better than even that your employer made you sign a document that would allow them to sue you into oblivion for forwarding some sure-to-be-doomed product launch draft to the wrong person. Being at least that careful with fine-grained medical data on hundreds/thousands of patients isn't exactly unreasonable...
Drawing a hard line on 100% complete, anonymous, and consequence-free access to troves of patient data isn't a reasonable position.
[1] https://journals.plos.org/plosone/article/file?id=10.1371/jo...
[2] https://www.ccs.neu.edu/home/jullman/cs7880s17/DSSV.pdf
And you can't simply strip out that data, because a lot of the subsequent analysis of effectiveness is dependent on it.
For example, when it comes to vaccine side-effects, I don't think there exists a true account for how common the side-effects really are. The most common way to report side-effects (VAERS, and similar national databases) are dismissed due to the self-reporting nature, local GPs frequently dismiss side-effects and tell people to just go home and take a Panadol with zero reporting going on (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"), etc.
Likewise, when it comes to vaccine effectiveness, there are a million and one confounding variables from % of the population that already had natural immunity, covid variants, health, age, seasonality, societal lockdowns, isolation, etc.
Also, it's important I think for us to raise the bar to the highest possible standard when you're talking about a medical intervention that was forced under significant duress (loss of job, social stigma, public/medical shaming) on a substantial percentage of the world's population. We should not be content as a society to come within inches of worldwide medical authoritarianism without asking some seriously hard fucking questions and imposing the absolute strictest and highest possible scientific standards to justify why.
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.
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.
Judging the risk/benefit ratio is the primary purpose of the regulatory agencies that approve vaccines. I don't see any reason to believe the claim that the vaccines are harmful for everyone below 50, that sounds quite outrageous to me. There have been adjustments based on new data for the vaccines a few times, e.g. younger people are generally recommended to be vaccinated with Biontech and not Moderna or AZ based on the side effects of these vaccines. That doesn't mean the risk/benefit ratio is bad there, it only means that we have vaccines with a more favorable profile for those age groups.
Another clear case of someone implying totally crazy things (younger folks without the vaccine would have been better without the vaccine) with absolutely NOTHING to support it.
However, collecting and analyzing that data would likely have eaten a percent or two into the eighty billion dollars Pfizer made last year, so I guess there's nothing we can do but trust the same authorities that brought us 'natural origin for sure', 'masks don't work', 'NNVTs don't mean anything any more', and 'Covid isn't airborne'.
If you bring lockdowns into the picture, you have to compare to what would have happened WITHOUT a lockdown as well, how many more deaths in hospitals, etc. The countries that tried this strategy have a very high excess death to compared to those that tried to limit human contacts (especially PRE vaccine).
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 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.
Source on that? Because all graphs I've seen show impossible to miss fluorescence around 35 cycles and up.
AFAICT VSD only does specific research at their own behest and currently don't have a section on COVID-19 vaccines.
Btw your link is dead.
I had pericarditis and some immediate reaction, my cardiologist thinks it was partially intravenously applied. Looking at the data on severe reactions from where I live I've been able to obviously tell that CDC must have used incredible criteria for their numbers. At least initially, I stopped caring when it eventually became clear to me that we do not really want to know how many are harmed.
And from the perspective of everyone involved I understand it, I too want this to be over, I too want this to be a safe magic bullet. But seems to me somewhere between 1:1000-10000 have significant heart issues from the Pfizer vaccine, but when we were rolling it out the numbers were claimed to be 1 in 230M.
It’s an editorial summarizing the first VSD report on Covid vaccine side effect research that I was describing (https://DOI.org/10.1001/jama.2021.15072)
I’m not going to argue that the US seemed to take longer and have worse communication about the myo/pericarditis issue than some other countries, but these things are being followed up on. The absolute timing I think is hard to discuss with a definite time frame
Here are some resources on PCR amplification:
- https://www.mcgill.ca/oss/article/covid-19-critical-thinking...
- https://www.thermofisher.com/us/en/home/life-science/cloning...
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-...
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.
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/
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.
When it comes to spread the vaccines may be even making the situation worse as the infected vaccinated people spread virus at the same level as infected unvaccinated while having less symptoms for the vaccinated means higher chances of them walking around spreading it.
>there were very troubling results from the clinical trials that were swept under the rug
this is why the clinical trials aren't going to conclude until few years down the road as operating under EUA is basically get-out-of-jail-free card for the BigPharma here.
https://www.hhs.gov/hipaa/for-professionals/privacy/special-...
I also worked on medical devices and respective medical advisory boards. Getting people to share their data is just a question away. If you fail at that, I doubt any further inquiry would net any benefit.
“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. And it’s not as simple as just removing the sensitive medical data because the primary or secondary analyses may be dependent on them.
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.
It's for the benefit of patients, and this raw data is already available, but under a loose NDA for commercial partners and researchers...
The fact that you poo-poo this question is telling. Preventing re-identification attacks is incredibly subtle and sometimes impossible. Removing "city and date of birth" is nowhere near sufficient.
> this raw data is already available, but under a loose NDA for commercial partners and researchers...
Yes. It's available to people who have their real identities tied to their access and can be sued into oblivion or possibly even prosecuted for wanton misuse of the data. Surely you see how this is different from throwing it on a public s3 bucket, right?
It reminds me the FDA saying they can't release the COVID-19 documents because reviewing 44'000 documents would take 50 years.
It didn't take 50 years to produce them...
Yes there is some effort needed to anonymize reasonably the data but it's not an impossible task. It's a question of motivation.
Here, clearly, the labs and administration don't really want to put efforts into that.
And, yes, I think public data on this sort of stuff is important and should be properly resourced.
I think:
Step 1. ASK PERMISSION before changing the way data is handled.
Step 2. Share full datasets more generously, but still gated by use and handling agreements. This probably means a private citizens without ethics research training and a supporting it dept can’t get a copy and peruse it on their personal laptop, but also that a truly enormous number of researchers would be able to access the data.
The gold standard of a CSV in a public s3 bucket shouldn’t be the enemy of good enough.
And of course raw data like this could benefit patients, but keeping access to raw data limited also benefits patients. Sure, the data is readily available under a loose NDA, but it's available to people who have explicit knowledge of the requirements around handling sensitive, identifiable data. Average Joe's and Jane's do not have this knowledge, and bad actors just plain don't give a shit.
And no, this isn’t under a “loose” NDA. This would be covered by HIPAA, which tends to be un-subtle about violations.
0 - https://www.cs.princeton.edu/~arvindn/publications/de-anonym...
Isn't that provably untrue? https://bits.blogs.nytimes.com/2015/01/29/with-a-few-bits-of...
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.
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?
You're comfortable sharing it, that's cool! Is your neighbor? Your friend? Your cousin? Should they be obligated to divulge their own medical information just because you're fine divulging yours?
Second, demonstrating your willingness to describe yourself on a public forum is a lot different than someone expecting confidentiality when participating in medical trials. Most people do not have your level of comfort disclosing medical details. Furthermore, if a company were to break that trust, why would anybody participate in medical trials? The harm is not to you, it is to society.
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 internet. Shocking, right?!
Apparently pseudonymous internet griping is an essential right but participants in medical trials should -- post-facto -- have their entire medical history shared in a wy that's at significant risk of reidentification.
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 little crazy how worried everyone is about being identified through round about methods in medical data. Google has a far better bead on exactly who I am than any doctor and, frankly, I'm far more worried about that advertising profile than I am about the "what if's" of my medical data being shared between hospitals and doctors (and potentially being leaked).
>My family...
>... I'm far more worried about that advertising profile than I am about the "what if's" of my medical data...
Again - yours. It's great that you're fine with your data being public, but as is evidenced by the way certain posts in this comment chain are being down/upvoted, clearly many other people share the opposite view and would prefer their data remain private.
AFAIK, the world hasn't ended and they aren't living in a dystopia because their medical information is so well documented. On the contrary it has served to stop the spread of genetic disorders and aid in medical research.
Certainly I personally don't have these hangups about privacy. I think it's weird that society has created them. Pre-HIPAA that wasn't the case and it wasn't exactly seen as major breaches of privacy for doctors/nurses to talk relatively openly about diseases their patients had. The sanctimony of medical data is a recent development practically unique to the US.
I'm not advocating that we broadcast to everyone details of every medical checkup. I am, however, saying that we shouldn't have nearly the level of restrictions we have around sharing medical information, particularly between medical institutions doing research.
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.
Citation needed.
You realize a couple of decades ago was 2000, right? The closest I can think of what you might be talking about is the eugenics programs ran up to the early 1960s. Even so, those weren't executions, but rather sterilizations. Barbaric, but not murder.
> And currently, today there places where it is acceptable to drown your own babies if they demonstrate delayed development.
And what part of making health recorders more accessible would influence that one way or another? Do you think it's the fact that heath records are hard to access that protects us from parents murdering their children? How are other nations in the EU managing to not kill all their kids for defects!
So, to be clear, your right to post random ass thoughts on the internet under a pseudonym is sacred... but it's totally reasonable to RENEGE on EXISTING privacy agreements with real world actual existing real human patients about intimate health records?
Just so long as we're clear about the enormous esteem you hold yourself in and the absolute contempt you have for others' privacy...
Address and name are not necessary.
- Person 30-35, living in California, has history of obesity, suffers from type II diabetes, under treatment of med A, and med B.
- first dose: Jan 2021
- second dose: March 2021
Medical outcome: ZZZ
This is irrelevant.
The conditional probability of my willingness to post this information, given your willingness to post this information, is equal to the the probability of my willingness to post this information. P(X) = P(X|Y). This means that just because you are okay with it, I'm not...and additional people being okay with it doesn't change my opinion regardless of harm.
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.
https://www.eeoc.gov/laws/guidance/your-employment-rights-in...
They are DEFINITELY not allowed to ask.
> "We are required to measure our progress toward having at least 7% of our workforce be individuals with disabilities. To do this, we must ask applicants and employees if they have a disability or have ever had a disability. Because a person may become disabled at any time, we ask all of our employees to update their information at least every five years.
Identifying yourself as an individual with a disability is voluntary, and we hope that you will choose to do so."
Just stop. This is embarrassing.
For example, having the list of symptoms, medications and even (just an imaginary example) pulmonary X-Ray or also on the chest having an open dataset of MRI pictures with the age of the patient, history of diseases would considerably help and there is no way you can link it back unless you know the history of the patient already (but then, what's the issue; none because you already know the information).
Plus if you ask the person about it, I really don't see the problem :|
Yes in theory, there is a possibility that someone has a database somewhere of all the boobs spacing, and can determine approximate lungs size, try to guess what could be the likely owner of a lung picture, etc etc, all of that for what ?
The person who is going to benefit from it, is clearly the COVID-19 researchers, and the end-patient.
No. Intent doesn't matter. That's the whole point.
To wit: there's a reason that reidentification attacks are called attacks! No one intends to be hacked, and writing a program that you intend to be secure doesn't imply that the program is in fact secure. So too with anonymization.
> having an open dataset of MRI pictures
But we're not talking about MRI pictures, are we?
OP strongly believes that, in this case, there is enough information to re-identify patients. I agree.
Plan A: - sit and do nothing "it's impossible to release any data, too bad, we'll never know!"
Plan B: - "we have a risk that a few % of ppl may be identified if we already know their medical history/details, it's impossible to release any data, too bad!"
Plan C: - "we remove the biggest identifiers to make sure the majority of the people cannot be reasonably identified, this is going to take a few days or weeks of work but will bring benefits to the overall population and transparency on the treatments"
I'm fully supportive of the right to pseudonymous speech, but it strikes me that you are in an awfully awkward position of speaking anonymously while demanding that you should have access a trove of patient history without signing any sort of data use agreement and without even the most basic step of getting permission from the people whose patient history you insist on seeing.
Asking the user:
"This record is going to be shared publicly, do you agree to share this information (without revealing your name and address) ?
> [...]
This information can help researchers, doctors and people interested into science to discover new information about drugs and diseases interaction."
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 "Rebecca", nobody knows it's her, except herself, and those to whom she decide to publicly disclose her conditions (e.g. on social networks or to specialists).
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.
Actually, set aside consent entirely.
The problem is NOT "how do we de-anonymize". That is super easy.
The problem is "how do we de-anonymize IN A WAY THAT LEAVES RESULTS OF RELEVANT STATISTICAL TESTS INVARIANT". Much harder. Remove a bunch of probably non-random points and make any logisitic regression on that dataset return the same result within some delta. There are trivial impossibility theorems. Really, really trivial. "Left as freshman exercise and if you can't some up with an example maybe step back and stop talking about this topic" trivial.
Now, add back consent. "how do we delete a subset of data that is likely not uniformly distributed with respect to risk variables and also de-anonymize the remaining subset of data.... AGAIN, IN A WAY THAT LEAVES RESULTS OF RELEVANT STATISTICAL TESTS INVARIANT". The position is untenable.
That is WAY harder that it sounds. When you add public disclosure of mismatch between results on public data and private (full) data things are even harder.
Specifically: suppose an independent researcher determines X is true via statistical test Y on the public dataset. Officials must respond, and say "True" or "False".
A small number of queries via this process can be used to infer data that makes re-identification possible. And there will be many more than a small number of queries, including from adversarial agents specifically designing queries to maximize information gain based on previous (public) revelations.
This is a game, in the game theory sense, in which the goal is to exploit the mathematical properties of statistical tests and social dynamics to force public revelations of binary assessments that yield information about individual cells or sets of cells and make re-id possible.
Have you actually studied this stuff, designed de-anonymization protocols, developed re-id threat models, thought about privacy budgets in public disclosure mandates, and at last put your reputation and your customer's privacy on the line when asserting that your statistical methods are resilient against attacks? Or are you just a jawboning know-it-all anonymous coward without any actual experience balancing privacy against public disclosure?
To be honest, all of your posts read like "just stop writing vulnerable software and then there will be no more hackers mmmkay?"
If you were to have access to my MRIs you could almost certainly identify me based on physical characteristics which can be seen in my MRI data which would correlate with data found on social media where I've sometimes generally discussed my medical conditions without going into specifics. There are MRIs for conditions I haven't discussed, in addition to the identifying ones I have.
There are a lot of people with fairly unique medical conditions and body situations (eg: missing a limb, surgical implants). The gap between "I got hurt in this way" and "here's the MRI scans of my body in detail along with other lab notes and other unrelated and possibly extremely embarrassing conditions" is huge
Until/unless patients agree otherwise.
I.e., the status quo.
Otherwise it's sort of like my 10-year-old wanting to help me replace an engine in a car. It's important to let him do it so he can learn but it's likely going to take me much longer to on-board him and get him up to speed than if I did it myself.
I have deposited datasets with full transcriptome data, which you can use to infer most of the genome in a straightforward manner, from clinical trials. In that case, you simply use off-the-shelf tools to anonymize datasets by flipping lots of SNPs. Additionally, raw data is made accessible only through an ethics committee. Summary counts from transcriptomes are publicly available, though. There are equivalent practices for other biomarkers.
I must say The British Biomedical Journal (BMJ) is really spearheading all transparency efforts. They have been publishing lots of inconvenient truths for many years. For example, they reported some fairly serious conflicts of interest where professors from Oxford are getting huge "consulting" fees from pharma. And they pretty much publish any reasonable letter to the editor. Nature, Science and Cell, on the other hand, are heavily biased.
Right.
1. I'm not sure you understand the extreme position being taken by rvnx in this thread.
2. Presumably the patients agreed that their transcriptome data could be shared in this way, and you didn't change your data handling post-facto without their consent.
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 in all but tiny studies.
The only exception I can think of is Scandinavia. They have national registries where all census information, plus electronic health records, is available to researchers by default, unless you explicitly opt out. Their philosophy is that this is a negligible reduction in privacy, in exchange for medical progress. I must note said records are not publicly open, you need to apply for access.
As a consequence, Sweden and Denmark have some of the best epidemiological research in the world and they've been able to spot pretty odd correlations (e.g. ibuprofen and male infertility).
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.
AFAIK this is also possible in the US. Probably more hoops to jump through? I don't know anything about the EU. (But also this discussion is basically totally unrelated to the original article or this thread.)
Your comment is somehow relevant to the article and insightful wrt the topic but also off-topic in this thread.
The type data you are suggesting should be shared -- and, more importantly, the consent assumptions -- are not related to the current discussion.
Facial recognition works perfectly fine on MRI face renders. You speak awfully confidently about a problem you seem to have very little experience in.
As with cryptography: Anyone can come up with suggestion that they themselves can't find an attack against.
FYI, high-res face MRI are just pictures of the face. So yes, if you share the picture of the face of someone, they may find your identity back, but it's not specific to MRI.
Dealing with any medical record that contains pictures of patient you should take additional steps to prevent identification, and face is the most sensitive part of the body as it can be most likely identified.
If tomorrow there are publicly available anonymised close-up pictures of cardiac MRI, it'd be extremely challenging to map them to their real owner with a 100% certainty but the discoveries it could lead to are very exciting (and the same with skin cancer pictures for example, or suspiciouses moles)
Even if you take more care than AOL did in anonymizing your data, the unfortunate reality is that any publication of data increases the knowledge an adversary has at identifying somebody. Anonymizing is more about reducing the chance someone is identified than guaranteeing they never will be. And high dimensional data is particularly hard to do so in a way that retains the data's usefulness.
33 bits is an old defunct blog on this topic, but it has some interesting posts and academic papers if you want to go down the rabbit hole: https://33bits.wordpress.com/about/
Specific paper on Netflix deanonymization: https://33bits.wordpress.com/about/netflix-paper-home-page/
This paper is a very good starting point:
https://papers.ssrn.com/sol3/papers.cfm?abstract_id=1450006
https://www.hhs.gov/hipaa/for-professionals/privacy/special-...
It's also possible to reach an outcome that the data can be shared but must be de-identified in a way that precludes important statistical tests. Any sparse feature is incredibly powerful for re-id, and combined with other features might be difficult to share without running afoul of de-id best practice. The problem: rare medical conditions that must be accounted for in a statistical study of vaccine side-effects are examples of sparse features. So you can share the dataset, but not in a way that's useful for a non-GIGO statistical study.
You also keep ignoring the issue of consent. Step one is to ask patients.
Or the person shared their story on the public website of a "Run For The Cure" style website about that genetic disorder.
Or so on.
"Sparse Features" aren't always a thing that the person wants to keep private.
https://vaers.hhs.gov/data/datasets.html
This is the type of raw records we are talking about, and they carry useful information.
Yes, maybe the dates could be anonymised better, if I know the age of someone, and I know when he got his vaccine precisely, and when he got his MRI and why he did it, then maybe I can find and connect back the record. But how likely this attack can be done in practice, and why would you do it to someone who already disclosed part of their records, plus how does it scale ?
However, the benefits are really present, it's not sharing just for the sake of sharing but to bring advance to the global research and knowledge of medicine.
In practice, who is it ? I don't know, who can know ? Doctors who can tie it to other pieces of information that we don't have...
However, in the meantime, the researchers and doctors who don't have these foreign keys, they can totally do interesting and useful discoveries about drug interactions and vaccine side-effects.
I get that some people want to prevent the use of the data for discrimination...just legislate that then.
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, is another story.
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.
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.
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.
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.
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.
I presume this would actually be the solution if the "raw data" people were making good faith requests.
Is there any reason why this wouldn't be viable?
As a number of sanctioned and disbarred lawyers have demonstrated, several groups in the US are quite happy to launch Denial of Service attacks against our institutions.
The easiest way to solve this is "You get <X> pages per month. If you want more than that, bring FDA certified folks to handle the job and pay them from your own coffers."
I don't see the people requesting the data to also be ponying up the money to get the data faster.
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.
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.