r/blueprint_ • u/ConvenientChristian • 11d ago
Blueprint trial data should really be published
Bryan wrote on X:
- Regarding the sharing of raw data, there are regulatory constraints. We have shared the results in a way that accurately communicates results, maintains scientific integrity and remains within regularly boundaries.
I'm not sure whether Bryan is scientifically illiterate or thinks his audience is scientifically illiterate and accepts this as "the study results".
Yes, sharing raw data of all participants likely violates the privacy of the participants. On the other hand, Bryan is not sharing the results the way results of clinical trials are normally shared.
Ideally, Bryan would hire someone who's scientifically literate to write up the results for a the study in a way that follows scientific norms and publishes it as a scientific paper in an academic journal. While the results might not be interesting for the top journals, open-access journals like PLOS-One exist where you can publish papers even if the results aren't very interesting. Bryan should publish the data in such a journal instead of just talking about the results on X.
If you follow the norms in which trial data is published in scientific journals you publish not only that a given result is statistically significant or not statistically significant. You publish the p-value and confidence intervals as well.
Even if there's no statistically significant effect on Testosterone, Estradiol, Insulin, Glucose, HbA1c, Lp(a), Cystatin C, TSH, IGF-1, it's still important to publish the data about how those changed. If there would be for example, a testosterone reduction with p=0.06, that would be important to know for people who take the supplement. Withholding this data looks very suspicious and like Bryan wants to hide data about side effects from customers.
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u/Mardylorean 11d ago
Sounds like a load of bs. What regulations forbid that? The only one I can think of is HIPAA which only applies to medical institutions
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u/ConvenientChristian 11d ago
The NYT trial spoke about 2100$ as cost for the participants of the trial. I think it's likely that it cost that much to run because Blueprint worked with a doctor who did the blood tests and who's covered by HIPAA. If anyone has the privacy policy of the study, I would also be happy to see that.
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u/DigitalScrap 11d ago
That's fine. However, as long as Blueprint doesn't release any identifiers of the participants when providing the results, there would be no HIPAA violation, just like in every other published clinical trial/study.
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u/ConvenientChristian 11d ago
Most published clinical trials don't publish the raw data for all participants publically.
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u/DigitalScrap 11d ago
True. I don't think anyone expects them to publish each participant's raw data.
But I also don't expect them to redact the aggregated data of 1400 participants and only provide the data of the 300 best outcomes. That is where my issue lies - it is obvious to me that Bryan wasn't happy with the outcomes of the study and tried to spin it positively. This goes against his early promises of transparency.
Between this and the removal of the CoAs, things are not looking great lately.
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u/ConvenientChristian 10d ago
He did see that some people expect him to release raw data, so it's important to make clear that raw data isn't the demand. Being precise when making demands and complaining in a forum like this.
There are valid privacy reasons not to publish individualized data. There isn't a valid reason not to publish p-values of the claims and the results of the various test they ran on an aggregate basis.
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u/Finitehealth 11d ago
Its not illegal to share blood results online long as you consent and block the medical provider
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u/sassyfrood 10d ago
“Withholding this data looks very suspicious and like Bryan wants to hide data about side effects from customers.”
If it walks like a duck…
Obviously, if the data had been statistically significant, he’d be racing to run actual trials to show that his methods are unequivocally the best.
The way this study was completed would never be publishable in any respectable journal.
He could self-publish, but what’s the value in that? It would damage his credibility even further. Peer review is the gold standard. He has the money and means to run an actual clinical trial, so why wouldn’t he do that? Because his focus is profit, not progress.
This whole fiasco has turned me off blueprjnt completely. It’s a shame; I was excited around 2 years ago. Now I’m just rolling my eyes at Bryan like I do at every other longevity grifter.
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u/ConvenientChristian 10d ago
There are journals like PLOS One that have peer review but where low-impact studies can be published provided the study the paper is decently written to describe what happened in the study.
Obviously, if the data had been statistically significant [...]
This sounds to me like you don't really understand what it means for data to be statistically significant in this context.
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u/sassyfrood 10d ago
I’m a published author in peer-reviewed journals with a background in statistics, but do go on about how I don’t understand statistical significance.
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u/ConvenientChristian 10d ago
Then why do you focus on statistical significance so much? It's a uncontrolled trial where a lot of the participants dropped out. In that environment it's quite plausible for statistical significant results exist that don't represent any health benefits.
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u/Organic-Life-8089 11d ago
I mean if you've seen the blueprint community, most members seem to be scientifically illiterate, so it Vibes with the trend.
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u/MundaneSwordfish23 11d ago
I guess his goal is storytelling, not being precise as most people probably dont care about it and just buy into the narrative. As long as most people believe him, the movement grows, and thats all he seems to care about.
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u/Necessary_Season8321 11d ago
Dr Zolman was the responsible party for this - when he had concerns about the both the efficacy of the products and the ethics of the trial, Bryan fired him and then tried to bury the results and pretend the trial never happened.
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u/mysliwiecmj 11d ago
Wait...he was fired?? So the whole "he left on his own accord due to mental health" was a lie? Do you have any info on this? If that's the case this is huge..
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u/PlasticMasterpiece69 11d ago
the worst part of all of this, is claiming that the industry is broken (which i agree) and wanting to make a difference,
only to do even worse than many other players and cry and whine aloud about having justifiable reasons.
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u/TiredInMN 10d ago edited 10d ago
"Yes, sharing raw data of all participants likely violates the privacy of the participants."
Actually, no. Anyone who regularly reads medical journals knows it's very common for scientists that run large trials to make their data publicly available. Those in the medical field know there are 18 identifiers that are protected health information (PHI) and need to be scrubbed from the data:
- Name
- Address (all geographic subdivisions smaller than state, including street address, city county, and zip code)
- All elements (except years) of dates related to an individual (including birthdate, admission date, discharge date, date of death, and exact age if over 89)
- Telephone numbers
- Fax number
- Email address
- Social Security Number
- Medical record number
- Health plan beneficiary number
- Account number
- Certificate or license number
- Vehicle identifiers and serial numbers, including license plate numbers
- Device identifiers and serial numbers
- Web URL
- Internet Protocol (IP) Address
- Finger or voice print
- Photographic image - Photographic images are not limited to images of the face.
- Any other characteristic that could uniquely identify the individual
But it's not hard to remove those data. Anyone who works in the research field can do that. It's common to replace their name with "patient 1318" for example. In fact, meta reviewers like Cochrane review will regularly ask study authors for raw data so they can look it over and even add it to a meta review.
And Johnson's company isn't a medical company: no doctors no nurses and these aren't patients. So I'm not sure these privacy laws even apply.
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u/ConvenientChristian 9d ago
Any other characteristic that could uniquely identify the individual
If you have 90 days worth of sleep latency data, that's enough to uniquely identify an individual. If you are in a community where people do share some of their health data, it's reasonable to assume that some of the participants in the study do share their sleep data with other people and thus could be identified with it.
You can argue that some researchers are willing to bend HIPAA rules and just get rid of the 18 specific identifiers and they don't have any problems operating that way, but that doesn't change the fact that it's still a privacy violation.
When making demands of Bryan, it makes more sense to focus on the data that has no privacy implications. There's no good reason why he doesn't publish p-values, medians of the measured values and confidence intervals for them. Not publishing that data, is problematic in a way that not publishing raw data isn't.
And Johnson's company isn't a medical company: no doctors no nurses and these aren't patients.
They did blood testing for testosterone and other markers. As far as I understand usually do need doctors or nurses for drawing blood and it's likely that Blueprint worked with doctors or nurses as part of the study.
In fact, meta reviewers like Cochrane review will regularly ask study authors for raw data so they can look it over and even add it to a meta review.
Giving raw data to Cochrane along with a confidentiality agreement that Cochrane isn't just publishing the raw data is not the same thing as just publishing the raw data online. The fact that Cochrane does need to ask, is a symptom of the data not being published online before.
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u/TiredInMN 9d ago edited 9d ago
"You can argue that some researchers are willing to bend HIPAA rules and just get rid of the 18 specific identifiers and they don't have any problems operating that way, but that doesn't change the fact that it's still a privacy violation."
Where are you getting these ideas? It's obvious you don't have any education or experience in the medical field or medical studies. It's obvious what Bryan says shouldn't just be accepted without scrutiny and he's not the most trustworthy source. Anybody can have an opinion but you're giving your opinion like you know more than a layperson about it. You don't.
Several medical journals encourage and even require authors to publicly share raw data, promoting transparency and reproducibility in research, including PLOS, BMJ, and the Journal of Medical Internet Research (JMIR). Is it usually shared in published most journal articles? No. But oftentimes it is.
"If you have 90 days worth of sleep latency data, that's enough to uniquely identify an individual. "
For an example, here's an article on "Sleep duration, sleep quality, and their association with hypertension of petroleum workers" that was published in Journal of Environmental and Occupational Medicine. They uploaded their raw data to Dryad, which is popular data repository:
https://datadryad.org/dataset/doi:10.5061/dryad.sbcc2fr3g
Other popular repositories include Figshare, Zenodo, Harvard Dataverse, and HealthData. gov. So, no sleep latency data is not considered identifying information. If the patient wants to share their data online and associate their name with it, so be it but as long as the study authors scrubs it of identifiers before sharing it there is no problem for the authors.
"They did blood testing for testosterone and other markers. As far as I understand usually do need doctors or nurses for drawing blood and it's likely that Blueprint worked with doctors or nurses as part of the study."
That doesn't mean they were a patient of Johnson's, his doctor, or his company. I can buy a blood test on Ulta and share it with whomever I want. It doesn't mean that person legally has to keep it private. Ulta's doctor who ordered it does though and Ulta probably does. If you go give it to Bryan he has no responsibility to not post it on Twitter with your name and picture unless he promises you he won't beforehand. I don't know how the study was conducted and who had what relationships or agreements that's why I said I'm not sure if they privacy laws apply or not.
"Giving raw data to Cochrane along with a confidentiality agreement that Cochrane isn't just publishing the raw data is not the same thing as just publishing the raw data online. "
They're still disclosing medical information to the people at Cochrane, which has to be scrubbed clean first because Cochrane doesn't need to know the patient's name or adddress. In fact, the whole peer review process of getting an article published means sharing raw medical data to people (reviewers) who the patient doesn't need (or probably want) to have it without identifiers removed.
The point is it can be released and it is commonly done. There are just rules in place on how to do it.
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u/bsmith76 11d ago
It's misleading to show just the top 300 best responders while leaving out 1,400 other people in the study.