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.
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.
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
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.
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).
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.
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.
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.
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.
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.
I'm not really clear on why FDA is even involved with the biopsy? Maybe because they made a statement relating to the DBS device. FDA only has authority over clinical trials. That means studies involving new devices or drugs (or new uses of them) that are intended to determine efficacy and safety. It's not obvious to me how these biopsies are related except through the association with modifications to DBS procedure and labeling that's intended for patient care.
Having just read the tweet linked below (since I can't get past the paywall) this seems Health and Human Services ballpark.
We can argue about whether FDA should have more oversight but there are very real restrictions on what FDA is actually authorized to do by Congress.
That's all to say: FOIA into FDA is interesting but the IRB seems responsible here and there's a claim the researchers deviated from approved consent forms. Anyway it just seems that this might be complaining the FDA didn't do something that it cannot do.
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? :-)
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.
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.
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.
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.
The limited time duration is a big deal, I agree. It's an extrapolation from insufficient data. (Though the studies were evidently powerful enough to come up with a number, so the probability is not that near 0.) But that also means insufficient data to provide evidence for net benefit from an intervention, and an intervention really needs to prove its worth before you go about tempting fate by taking something biologically active. Where is the evidence that statins "reduce the risk of ever having a heart attack"?
I'm going to disagree about the cohort. That only means that if you have prior heart disease, you should not be looking at an NNT derived from a population without prior heart disease. The site's conclusions are mostly irrelevant for you, and should not factor into a rational decision.
If you don't have prior heart disease and are weighing your options, then those data are relevant to you. The vast majority of people who are deciding whether to take statins are in this category.
People deciding whether to try to remove a bullet from their abdomen, and who have no reason to believe that they have ever been shot, should not be weighing the outcomes of test subjects who had been shot before participating in the trial. (It would really suck to be in the control group...)
I'm not saying you shouldn't take statins, with or without prior heart disease. An individual would have more to go on than the existence or absence of a prior heart disease diagnosis. Exact cholesterol readings, for example, might create more or less urgency.
But if I were in the situation of deciding for myself, I'd want better evidence for them than I have seen presented so far. I am suspicious of an industry for which this is a big success story.
Without being able to see through the paywall, its hard to know whether the "false justification" was a technicality or something serious and nefarious.
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
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.
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[ 2.9 ms ] story [ 121 ms ] threadWith 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.
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
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.
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).
Anybody who has played much D&D knows that a 1% chance isn't as low as it sounds.
- 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.
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.
And it’s not like the outcomes are random so that <1% bad outcome with unknown causes could be 100% for a gene she has.
Her fear isn’t completely irrational as perhaps her stats knowledge is useful to not assume perfect estimation of those odds.
I always found it interesting how people assume numbers are spot on when they are frequently just estimates or averages of multiple experts guessing.
Having just read the tweet linked below (since I can't get past the paywall) this seems Health and Human Services ballpark.
We can argue about whether FDA should have more oversight but there are very real restrictions on what FDA is actually authorized to do by Congress.
That's all to say: FOIA into FDA is interesting but the IRB seems responsible here and there's a claim the researchers deviated from approved consent forms. Anyway it just seems that this might be complaining the FDA didn't do something that it cannot do.
https://archive.ph/1bwiw
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-...
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.
I'm going to disagree about the cohort. That only means that if you have prior heart disease, you should not be looking at an NNT derived from a population without prior heart disease. The site's conclusions are mostly irrelevant for you, and should not factor into a rational decision.
If you don't have prior heart disease and are weighing your options, then those data are relevant to you. The vast majority of people who are deciding whether to take statins are in this category.
People deciding whether to try to remove a bullet from their abdomen, and who have no reason to believe that they have ever been shot, should not be weighing the outcomes of test subjects who had been shot before participating in the trial. (It would really suck to be in the control group...)
I'm not saying you shouldn't take statins, with or without prior heart disease. An individual would have more to go on than the existence or absence of a prior heart disease diagnosis. Exact cholesterol readings, for example, might create more or less urgency.
But if I were in the situation of deciding for myself, I'd want better evidence for them than I have seen presented so far. I am suspicious of an industry for which this is a big success story.
Not the actual mountain mind you, there you'd probably be diagnosed with an acute case of Shahed drone instead.
https://threadreaderapp.com/thread/1785740414420422819.html