Brain biopsies on 'vulnerable' patients at Mt Sinai set off alarm bells at FDA

75 points7
hammock4 hours ago

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

gumby3 hours ago

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.

uniqueuid3 hours ago

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).

JohnFen3 hours ago

> 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.

wlesieutre3 hours ago

I was thinking XCOM. Rely on a 90% chance to hit a couple of times and you'll lose the mission.

itronitron3 hours ago

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.

rangerelf2 hours ago

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.

mistrial93 hours ago

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.

psvv3 hours ago

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.

christophilus2 hours ago

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.

binary1322 hours ago

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.

ceejayoz3 hours ago

A one-in-five chance of the pain not getting any better is frequently worthy of dread on its own.

kevinventullo3 hours ago

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.

colechristensen35 minutes ago

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.

felipellrocha4 hours ago

H... House...? Is that you?

coffeebeqn4 hours ago

Sounds like a minor lobotomy

thiagoeh4 hours ago

not my area of experise, but I wouldn't call 2 pieces of up to 1 cubic centimeter "minor". Looks significant to me

jonnycomputer3 hours ago

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.

GrantMoyer2 hours ago

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 ⅓ of the approved maximum.

jonnycomputer2 hours ago

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.

ars2 hours ago

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.

escapecharacter4 hours ago

as a treat

mkmk3 hours ago

Since this is so effectively paywalled, it's probably worthwhile to note that much of the story explained here in this tweet thread:

justinclift3 hours ago

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.
mewse-hn3 hours ago

I don't have a twitter account but was able to read the thread here:

itscrush3 hours ago
ineedaj0b45 minutes ago

works for me!

elzbardico2 hours ago

Paywalled article not accessible through archive.

mistercheph4 hours ago

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.

flybrand3 hours ago

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.”

pakitan3 hours ago

Yes, and future spaceships will travel 100x times the speed of light.

snapcaster3 hours ago

You really think we're up against fundamental limits of medicine? I'm struggling to understand your meaning here

pakitan2 hours ago

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.

sfink2 hours ago

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.


jonnycomputer4 hours ago

Without being able to see through the paywall, its hard to know whether the "false justification" was a technicality or something serious and nefarious.

derbOac32 minutes ago

The latter.

jonnycomputer4 hours ago

I hate to ask this, but anyone have a non-paywalled link?

mikestew3 hours ago

No offense intended, but you've been hanging out on HN for seven years and haven't figured out Where did you think those links come from? :-)

onemoresoop3 hours ago

This archived content cuts off exactly where the paywalled article does.

advisedwang3 hours ago

No offense intended, but did you look at the archive link you posted? It has the same paywall.

dodox3 hours ago has the paywalled version.

tapper2 hours ago

I hate paywalls!

moffkalast3 hours ago

> 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.

selimthegrim2 hours ago

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

moffkalast36 minutes ago

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.