[HN Gopher] Brain biopsies on 'vulnerable' patients at Mt Sinai ...
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Brain biopsies on 'vulnerable' patients at Mt Sinai set off alarm
bells at FDA
Author : chapulin
Score : 77 points
Date : 2024-05-15 15:48 UTC (7 hours ago)
(HTM) web link (www.statnews.com)
(TXT) w3m dump (www.statnews.com)
| coffeebeqn wrote:
| Sounds like a minor lobotomy
| escapecharacter wrote:
| as a treat
| thiagoeh wrote:
| not my area of experise, but I wouldn't call 2 pieces of up to
| 1 cubic centimeter "minor". Looks significant to me
| jonnycomputer wrote:
| Apparently the IRB approval was for up to 1 cubic cm, but
| according to Mt. Sinai, the average actually obtained is
| 0.04cc, far less.
| GrantMoyer wrote:
| Note that 0.04 cm3 is the volume of a cube with side length
| [?] 0.34 cm, so in the way we usually think of scale, the
| average was about 1/3 of the approved maximum.
| jonnycomputer wrote:
| Yes, but its about 4% of the total maximum volume, not a
| third. Its just that the "sides" of the cube are about a
| third of the maximum. Like, if it had a constant density,
| it'd be 4% of the mass of the maximum, not a third.
| ars wrote:
| According to the article the amount of brain tissue lost is
| the same either way.
|
| With this study they cut it out, remove, and study it,
| without the study they burn it away.
|
| If that's really the case, then this seems like a non story
| to me.
| hammock wrote:
| The researchers claimed the biopsies were low-risk, but the FDA
| found this was a "false justification" to obtain patient consent.
|
| Super important that doctors discuss the risks, even the rare
| ones, when severe, with patients before doing a procedure/jabbing
| them with something/putting them on a pharmaceutical
| gumby wrote:
| It's hard for people to evaluate risk. This morning my gf said
| she was "living in dread" of an upcoming procedure: 80% chance
| of success, almost 20% chance of doing nothing, <1% chance of
| things going very wrong. She's in a lot of pain so elected to
| do it. Her worry is affecting her sleep.
|
| This is despite the fact that her PhD was extremely statistics-
| heavy, and she still does statistical analysis in her job, not
| every day, but more than once a week. Admittedly she's not a
| medical statistician, but I don't think that should matter.
| kevinventullo wrote:
| I mean how much < 1%? If it's a 1 in 200 chance of things go
| south, I can sympathize with losing sleep over it. 1 in 100k,
| maybe not so much.
| uniqueuid wrote:
| A big part of the problem is that as patients, we observe
| single discrete outcomes.
|
| For doctors an aggregate 1% chance is low, but the
| realization of the outcome in a single person is not a
| percentage, its binary bad side effects or not.
|
| Admittedly, doctors could usually do better in communicating
| risks (e.g. see the famous example of 1/3 risk of impotence,
| which patients interpret either as 1 out of 3 people, 1 out
| of 3 times having sex, or 1/3 of the time of sex).
| JohnFen wrote:
| > For doctors an aggregate 1% chance is low
|
| Anybody who has played much D&D knows that a 1% chance
| isn't as low as it sounds.
| wlesieutre wrote:
| I was thinking XCOM. Rely on a 90% chance to hit a couple
| of times and you'll lose the mission.
| mistrial9 wrote:
| unfortunately I agree that 1% is non-negligible.. I met a
| man who had Lasik eye procedure around 2000 and it went
| badly.. prism vision for life.
| itronitron wrote:
| Many years ago, while developing data analysis software, my
| employer was able to receive a 'sample' dataset of patient
| outcomes from a prospective client. There were many
| fatalities as the patient outcome of elective surgeries.
| rangerelf wrote:
| It doesn't matter what the probabilities are when the
| stakes are high:
|
| - 1% chance of living the rest of your life in mind numbing
| pain
|
| - 50% chance of having to remove that pesky wisdom tooth
|
| (numbers pulled out of thin air)
|
| In the first case, I'd really really think about it hard
| and deep, and question myself if it's really that
| necessary; in the second, meh, worst case I lose a wisdom
| tooth.
| psvv wrote:
| It's not just the risk percent but also the scale of "very
| wrong" that matters.
|
| Sounds like she is proceeding with the procedure despite this
| fear, which seems to indicate to me a fairly astute
| assessment of the risk.
|
| However, I agree people are generally not very good at
| evaluating risk.
| ceejayoz wrote:
| A one-in-five chance of the pain not getting any better is
| frequently worthy of dread on its own.
| christophilus wrote:
| Well, how much less than 1% are we talking? I'd be worried
| about something really bad that had a 1 in 200 chance of
| happening, for example. I would be worried about playing a
| single round of Russian Roulette with a 200-chamber revolver.
| binary132 wrote:
| There's a huge difference between rationally evaluating risk
| and how we feel about risk. Just because I rationally
| understand and choose a certain set of risks, doesn't mean I
| can necessarily make myself feel good or even okay about
| them. Even a small or inconsequential amount of risk can be
| really scary if the potential bad outcome is really bad.
| colechristensen wrote:
| Yeah humans are bad at exponentials and volumes. What's the
| difference between one in a thousand or a million or a
| billion? It's quite hard to treat those chances differently.
| jonnycomputer wrote:
| I hate to ask this, but anyone have a non-paywalled link?
| mikestew wrote:
| No offense intended, but you've been hanging out on HN for
| seven years and haven't figured out archive.ph? Where did you
| think those links come from? :-)
|
| https://archive.ph/1bwiw
| dodox wrote:
| Archive.ph has the paywalled version.
| onemoresoop wrote:
| This archived content cuts off exactly where the paywalled
| article does.
| advisedwang wrote:
| No offense intended, but did you look at the archive link you
| posted? It has the same paywall.
| mistercheph wrote:
| We will look on the notions and practices of medical care in the
| present with as much mirth as the bloodletters, plague doctors,
| and humor examiners of the past have provided us.
| pakitan wrote:
| Yes, and future spaceships will travel 100x times the speed of
| light.
| snapcaster wrote:
| You really think we're up against fundamental limits of
| medicine? I'm struggling to understand your meaning here
| pakitan wrote:
| I'm just making fun of the certainty with which the poster
| assumes that just because we had humongous progress in all
| areas of knowledge for the last 100 years, it's somehow
| guaranteed that the progress will continue at the same
| rate. Fundamental limits or not, we've already picked the
| lowest hanging fruit and further progress is painfully
| incremental, slow and expensive and Star Trek-like devices
| seem extremely unlikely.
| sfink wrote:
| I think you're reading it backwards. If you look closely
| at how medicine is done today, you will see that there
| are many areas where it is wildly divorced from reality.
| So, the point was not "we'll be vastly better soon", it's
| more "we're in a bad place now".
|
| The current most wildly successful, heavily prescribed
| medicines today are statins. They help 1 in 104 people in
| terms of preventing heart attacks, 1 in 154 people in
| terms of preventing stroke. (Those are people without
| known heart disease, but they are the vast majority of
| people taking statins.) They harm 1 in 10 by causing
| muscle damage, 1 in 50 by causing diabetes. [1] That's
| the _success_ story. (Sure, you can debate the details.
| Do they really _cause_ diabetes? Unclear. Do they help
| anyone, ever, to not die sooner? Unclear.)
|
| It seems like the main reason they're considered so
| successful is that they do indeed lower an intermediate
| metric, namely blood cholesterol level. I am sure that
| bloodletting was successful at removing blood, and if you
| have an infection, you could even say at removing bad
| blood.
|
| And yes, I'm cherrypicking my definition of success.
| Modern medicine can indeed dramatically improve outcomes
| for a large set of problems (eg cancer). But doctors were
| successfully setting bones back in the bloodletting days,
| too.
|
| [1] https://thennt.com/nnt/statins-for-heart-disease-
| prevention-...
| nonameiguess wrote:
| There is a serious problem with that site's analysis. The
| meta cited on statin death prevention covered an average
| trial length of 3.74 years per person. That means they
| can give you, at best, your 3-4 year probability of
| having a fatal heart attack. For most age cohorts, that
| probability is very near 0 no matter what you do, so no
| intervention whatsoever can prevent cardiac event death
| by this metric. But this metric isn't what people care
| about. They're not trying to reduce the risk of having a
| heart attack in the next few years. They're trying to
| reduce the risk of _ever_ having a heart attack.
|
| Note this is exactly why we actually use the studies of
| people with prior cardiovascular disease that this meta
| excludes. Those people are sufficiently likely to
| actually have another heart attack within the time
| horizon of the study that you can get useful data!
|
| The other option is to only conduct 60 year trials. It
| should be obvious why that isn't a viable option.
| flybrand wrote:
| There's a saying I've heard, can't fully recall, "why go to the
| doctor - I either get a cut, an injection, or nothing."
| felipellrocha wrote:
| H... House...? Is that you?
| jonnycomputer wrote:
| Without being able to see through the paywall, its hard to know
| whether the "false justification" was a technicality or something
| serious and nefarious.
| derbOac wrote:
| The latter.
| moffkalast wrote:
| > at a Mount Sinai medical facility in midtown Manhattan
|
| Not the actual mountain mind you, there you'd probably be
| diagnosed with an acute case of Shahed drone instead.
| selimthegrim wrote:
| In case you haven't noticed Egypt and Iran haven't been best
| buddies since approximately the Fatimid dynasty (and Iran
| wasn't even Shiite then). You have to go back even further to
| find the last time Persia ruled Egypt
| moffkalast wrote:
| I was thinking more about stray hits flying over in Israel's
| general direction since it's close by, but you do make a good
| point. They could just shoot at Egypt directly.
| mkmk wrote:
| Since this is so effectively paywalled, it's probably worthwhile
| to note that much of the story explained here in this tweet
| thread:
| https://twitter.com/KatherineEban/status/1785740414420422819
| justinclift wrote:
| That just gives an error when I try to visit it:
| Something went wrong, but don't fret -- let's give it another
| shot.
|
| Repeatedly, never loading the expected content.
| itscrush wrote:
| https://threadreaderapp.com/thread/1785740414420422819.html
| appeared to work for me
| mewse-hn wrote:
| I don't have a twitter account but was able to read the
| thread here:
|
| https://threadreaderapp.com/thread/1785740414420422819.html
| ineedaj0b wrote:
| works for me!
| elzbardico wrote:
| Paywalled article not accessible through archive.
| tapper wrote:
| I hate paywalls!
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(page generated 2024-05-15 23:01 UTC)