6 ms·

It’s not shameful, it’s how evidence based medicine works. One case is interesting but not a basis for changing a protocol by itself. Tons of things could have

by ch4s3 1y ago

It’s not shameful, it’s how evidence based medicine works. One case is interesting but not a basis for changing a protocol by itself. Tons of things could have influenced the outcome and you need a proper study to know that.

wyldfire 1y ago
Though it could certainly inspire such a study.
- ch4s3 1y ago
  Sure, but someone needs to fund, organize, and conduct the study. If you're not at a research hospital it's not as easy for a one off case to generate a study.
  - vlovich123 1y ago
    This is a fairly innocuous change the doctor should be organizing on their own to publish a pilot study. In terms of funding very little would be required since you’re just making a small adjustment to when an existing drug regimen is happening which you already isn’t a controlled factor requiring FDA oversight or anything.
    - _qua 1y ago
      Even simple studies are expensive and difficult. You need IRB approval, data collection and organization, staff to do those things. It seems simple from the outside but making it happen takes time, effort, and money which then means also applying for grants which is a process in and of itself.
      - renewiltord 1y ago
        Indeed, as any ethicist worth his salt would argue: we don’t want anyone saving lives without proper approval.
        vkou 1y ago
        Any ethicist worth your salt would presumably have no problem approving experiments that will also cost lives. There are an endless number of parameters in medicine that can be fiddled with. If an N=1 sample were enough to convince you, all sorts of garbage would meet that pattern.
        refurb 1y ago
        What a intellectually lazy response. No, it would be more accurate to say "any ethicist worth his salt would argue: don't make changes that could be harmful based on a hunch"
        southernplaces7 1y ago
        I think it was a bit tongue in cheek, not so much lazy. Also, considering the kinds of gatekeeping and forced "concerns" I've seen some ethicists push forth just for the sake of showcasing their fixations instead of really looking at costs and benefits, I don't think it's far off the mark on reality to argue that medical ethics is worth considerable scrutiny too, and shouldn't hid behind a mantle of being above criticism.
      - echelon 1y ago
        It's no wonder biology hasn't even entered into the punch-card phase. When I did my bio undergrad I was keenly aware our bodies are just scaled up molecular machines. I was hoping for a future where we'd grow MHC-neutral clonal bodies for organ harvesting. Nope. We're in the stone age.
        _qua 1y ago
        Move fast and break things in human medicine means unethical researchers maim and kill people, often marginalized people. Nazis, Japanese experimenting on prisoners, Tuskegee airmen syphilis experiments, Cincinnati radiation experiments and many others stand as testament to what ambitious unethical scientists will do to further their knowledge and career. Thus we have strict guardrails that slow down how we do things.
        echelon 1y ago
        We've been able to clone mammals for 30 years and haven't acted on it. We're still toying with molecular systems beyond the limit of detection. Clone humans. Cut off their brain stem during development. Turn off cephalization signals for good measure. Scale it up to industrial scale. Research problems solved. We'd have every study at our fingertips. We'd have organs and tissue and blood for everyone. We could possibly even do whole head transplants and cure all non-blood, non-brain cancers. But we're playing in the sand.
        cannonpr 1y ago
        You might be surprised at how little of the body still functions without brain function, well, some bits of the brain, including basic homeostasis and immune system function.
        echelon 1y ago
        We're not at all trying. If you toss out the old rule book and provide unlimited funding, it can be made to work.
      - vlovich123 1y ago
        If a study like this needs a complicated IRB approval or extra data collection vs what’s already being collected for health records, you’re doing it wrong and the process has become more important than the problem you’re trying to solve.
        dotancohen 1y ago
        > the process has become more important than the problem you’re trying to solve. This holds true in almost every professional field for which life is on the line. Medicine, class 3 electronics, aviation. We have a word for this, which roughly translates to "rule of paperwork". Bureaucracy.
        darkwater 1y ago
        And I think there is a reason why the bureaucracy exists in these cases. "Move fast and break things" doesn't work very well there.
        owenthejumper 1y ago
        What happens if your study clearly hurts people? What happens if your study clearly helps people? You find out in the first few weeks, what do you do? How do you ensure you collected enough of a sample of a general population to make your study representative? How do you ensure your patients properly consented to the study (past shameful human experiments aside, you likely need many institutions participating, so you can't control everything yourself). Do I keep going or is the IRB approval process clearer now? There is a reason it exists.
        Panzer04 1y ago
        We can appreciate that process is important, but at some point you're falling down a slippery slope here, surely? We're talking about a factor that no one has previously had reason to consider important. Of course, I don't know hard it truly is to undertake a study. I have to imagine for something like this you could write up a basic study protocol in fairly short order.
        1y ago
  - more_corn 1y ago
    Or you could consider if there’s reason to believe there’s a causal relationship, if there is you could change your protocol (offer it in the evening as an option), measure the improvement, publish the result and simultaneously improve your patient outcomes and move science forward.
  - daveguy 1y ago
    That's why doctors publish case studies all the time -- to inspire larger scale and statistically sound studies.
AbrahamParangi 1y ago
The razor to use to determine whether something is actually evidenced based under uncertainty is whether you would follow the same policy if it was your own child. There are many things that are simply uncertain and “untrue until proven otherwise” isn’t an exclusively optimal policy.
- raverbashing 1y ago
  It's ok, the strongest defenders of EBM are never going to discover anything worthwhile as they get caught in a loop of "no evidence enough to test" and "no evidence for this because nobody tests it"
  - vrc 1y ago
    Counterpoints: the detractors of this purported loop would likely neither fund the vast amounts of research they’d demand be done nor believe the results if they conflicted with their anecdata. I have yet to see a good faith argument against evidence based method that provides an effective and realistic alternative. Because that would take evidence.
  - ch4s3 1y ago
    The opposite approach exposes people to a lot of unnecessary and dangerous medical treatment. The evidence based approach has uncovered that stenting doesn't work[1], yet a lot of do something proponents are still installing them at great risk to patients and at great cost to medical systems. [1] https://lowninstitute.org/stents-dont-work-a-look-back-at-the-research/ https://lowninstitute.org/stents-dont-work-a-look-back-at-th...
- h2782 1y ago
  > The razor to use to determine whether something is actually evidenced based under uncertainty is whether you would follow the same policy if it was your own child. What? This makes no sense. How do you explain anti-vaxxer parents with this perspective? Parents may feel they know best, but feeling and fact have nothing to do with each other.
echelon 1y ago
> It’s not shameful, it’s how evidence based medicine works. Yeah, but I'll bet nothing happened as an outcome of this. No study, no communication to anyone else. That information probably just withered on the vine. I did a molecular bio undergrad and had classes with a bunch of pre-med students. They had zero interest in the science, just getting A's. They did care about appearance and money, driving cool cars, and dating hot partners. I know my experience is purely anecdotal and not indicative of all doctors, but I came away from my undergrad experience highly unimpressed with our medical feedstock. The only students in upper level electives that cared were the research-track students. I talk to my doctors regularly about medicinal chemistry and biochem -- they don't know anything. It's embrassing how little they retain or care.
- calf 1y ago
  "Evidence-based" is a really problematic term when it is used to protect bureaucracies and medical managerialism, rather than actually interact with scientific processes in an ethical way. Their anecdote is actually a good example of why evidence-based logic is not the end-all.
  - uselesswords 1y ago
    [flagged]
    - echelon 1y ago
      Barry James Marshall
      - uselesswords 1y ago
        [flagged]
        uselesswords 1y ago
        Since no one wants to explain and you I just got downvoted, Barry James Marshall is ironically an example of EBM and is HIMSELF an active proponent of EBM. He had a biological hypothesis that the scientific community disagreed with and tested it on himself for a case study to get data. That case study was successful and then became a clinical trial. That trial was replicated and shown to work. He then won a Nobel prize for that work and the risk he took. This is an evidence-based process. EBM doesn’t mean you disregard a N=1, it means you expand N=1 into N=10, then N=100,… before you apply something to the general population. This is loosely how phase-1,2,3,4 trials work in the US. Dismissing EBM because of Marshall is like dismissing all of math because someone disproved a popular conjecture like the local-to-global conjecture. Sure the community sentiment had it wrong, but the systematic logical approach of Math got it right. In Marshall’s case the community sentiment had it wrong, but the EBM approach eventually got it right. Half this thread doesn’t even know what they are arguing against.
teekert 1y ago
It is not shameful indeed. One never knows what the father had experienced if he had been given the therapy during the day. The oncologist could have written a paper (there are many single case papers), or started a trial by himself (requires a lot of organizing) if he was very intrigued. But of course one can’t do that for every above average case. I have to say, in this particular case there is a very plausible mechanism and the trial would not be that hard. So it is a real shame that nothing was done with this.
- raylad 1y ago
  Previous rounds of chemo were done on the normal morning infusion schedule and he ended up with a completely depleted immune system and was put in strict quarantine. He also got multiple infections that were life threatening. This is the reason I started looking into the alternate dosing schedule.
jcims 1y ago
Well the concept is now being studied quite closely. Had someone taken it seriously thirty years ago it's quite possible that the net amount of suffering that millions of patients have endured since then could have been reduced. https://pmc.ncbi.nlm.nih.gov/articles/PMC9599830/ https://pmc.ncbi.nlm.nih.gov/articles/PMC9599830/ I'm comfortable calling that shameful. Not on any one in particular, it's a systemic problem that could be reduced with sufficient tenacity and courage to take risks.
- ch4s3 1y ago
  There's limited time and a finite supply of doctors and researchers. They can't study everything that's promising all at once, and good ideas fall through the cracks all of the time.
  - JamesSwift 1y ago
    I think this clears a bar of things that are useful and simple to study. Theres basically no effort involved. If it ends up beneficial we just update job postings from 'daytime infusion tech' to 'nighttime infusion tech'. Instant improvement in outcomes. I doubt you even need to clear this in any way to get the study greenlit.
    - jcims 1y ago
      Agreed. Scheduling is patient discretion anyway. It's the lowest bar possible as far as I can tell.
- refurb 1y ago
  > Had someone taken it seriously thirty years ago it's quite possible that the net amount of suffering that millions of patients have endured since then could have been reduced. You can only say that with hindsight because of the data over the past 30 years. What if the data showed the opposite? Then the doctor would have given his patients a worse outcome all on a "hunch".

by ch4s3 1y ago

wyldfire 1y ago

Though it could certainly inspire such a study.

ch4s3 1y ago
Sure, but someone needs to fund, organize, and conduct the study. If you're not at a research hospital it's not as easy for a one off case to generate a study.
- vlovich123 1y ago
  This is a fairly innocuous change the doctor should be organizing on their own to publish a pilot study. In terms of funding very little would be required since you’re just making a small adjustment to when an existing drug regimen is happening which you already isn’t a controlled factor requiring FDA oversight or anything.
  - _qua 1y ago
    Even simple studies are expensive and difficult. You need IRB approval, data collection and organization, staff to do those things. It seems simple from the outside but making it happen takes time, effort, and money which then means also applying for grants which is a process in and of itself.
    - renewiltord 1y ago
      Indeed, as any ethicist worth his salt would argue: we don’t want anyone saving lives without proper approval.
      - vkou 1y ago
        Any ethicist worth your salt would presumably have no problem approving experiments that will also cost lives. There are an endless number of parameters in medicine that can be fiddled with. If an N=1 sample were enough to convince you, all sorts of garbage would meet that pattern.
      - refurb 1y ago
        What a intellectually lazy response. No, it would be more accurate to say "any ethicist worth his salt would argue: don't make changes that could be harmful based on a hunch"
        southernplaces7 1y ago
        I think it was a bit tongue in cheek, not so much lazy. Also, considering the kinds of gatekeeping and forced "concerns" I've seen some ethicists push forth just for the sake of showcasing their fixations instead of really looking at costs and benefits, I don't think it's far off the mark on reality to argue that medical ethics is worth considerable scrutiny too, and shouldn't hid behind a mantle of being above criticism.
    - echelon 1y ago
      It's no wonder biology hasn't even entered into the punch-card phase. When I did my bio undergrad I was keenly aware our bodies are just scaled up molecular machines. I was hoping for a future where we'd grow MHC-neutral clonal bodies for organ harvesting. Nope. We're in the stone age.
      - _qua 1y ago
        Move fast and break things in human medicine means unethical researchers maim and kill people, often marginalized people. Nazis, Japanese experimenting on prisoners, Tuskegee airmen syphilis experiments, Cincinnati radiation experiments and many others stand as testament to what ambitious unethical scientists will do to further their knowledge and career. Thus we have strict guardrails that slow down how we do things.
        echelon 1y ago
        We've been able to clone mammals for 30 years and haven't acted on it. We're still toying with molecular systems beyond the limit of detection. Clone humans. Cut off their brain stem during development. Turn off cephalization signals for good measure. Scale it up to industrial scale. Research problems solved. We'd have every study at our fingertips. We'd have organs and tissue and blood for everyone. We could possibly even do whole head transplants and cure all non-blood, non-brain cancers. But we're playing in the sand.
        cannonpr 1y ago
        You might be surprised at how little of the body still functions without brain function, well, some bits of the brain, including basic homeostasis and immune system function.
        echelon 1y ago
        We're not at all trying. If you toss out the old rule book and provide unlimited funding, it can be made to work.
    - vlovich123 1y ago
      If a study like this needs a complicated IRB approval or extra data collection vs what’s already being collected for health records, you’re doing it wrong and the process has become more important than the problem you’re trying to solve.
      - dotancohen 1y ago
        > the process has become more important than the problem you’re trying to solve. This holds true in almost every professional field for which life is on the line. Medicine, class 3 electronics, aviation. We have a word for this, which roughly translates to "rule of paperwork". Bureaucracy.
        darkwater 1y ago
        And I think there is a reason why the bureaucracy exists in these cases. "Move fast and break things" doesn't work very well there.
      - owenthejumper 1y ago
        What happens if your study clearly hurts people? What happens if your study clearly helps people? You find out in the first few weeks, what do you do? How do you ensure you collected enough of a sample of a general population to make your study representative? How do you ensure your patients properly consented to the study (past shameful human experiments aside, you likely need many institutions participating, so you can't control everything yourself). Do I keep going or is the IRB approval process clearer now? There is a reason it exists.
        Panzer04 1y ago
        We can appreciate that process is important, but at some point you're falling down a slippery slope here, surely? We're talking about a factor that no one has previously had reason to consider important. Of course, I don't know hard it truly is to undertake a study. I have to imagine for something like this you could write up a basic study protocol in fairly short order.
        1y ago
- more_corn 1y ago
  Or you could consider if there’s reason to believe there’s a causal relationship, if there is you could change your protocol (offer it in the evening as an option), measure the improvement, publish the result and simultaneously improve your patient outcomes and move science forward.
- daveguy 1y ago
  That's why doctors publish case studies all the time -- to inspire larger scale and statistically sound studies.

AbrahamParangi 1y ago

The razor to use to determine whether something is actually evidenced based under uncertainty is whether you would follow the same policy if it was your own child. There are many things that are simply uncertain and “untrue until proven otherwise” isn’t an exclusively optimal policy.

raverbashing 1y ago
It's ok, the strongest defenders of EBM are never going to discover anything worthwhile as they get caught in a loop of "no evidence enough to test" and "no evidence for this because nobody tests it"
- vrc 1y ago
  Counterpoints: the detractors of this purported loop would likely neither fund the vast amounts of research they’d demand be done nor believe the results if they conflicted with their anecdata. I have yet to see a good faith argument against evidence based method that provides an effective and realistic alternative. Because that would take evidence.
- ch4s3 1y ago
  The opposite approach exposes people to a lot of unnecessary and dangerous medical treatment. The evidence based approach has uncovered that stenting doesn't work[1], yet a lot of do something proponents are still installing them at great risk to patients and at great cost to medical systems. [1] https://lowninstitute.org/stents-dont-work-a-look-back-at-the-research/ https://lowninstitute.org/stents-dont-work-a-look-back-at-th...
h2782 1y ago
> The razor to use to determine whether something is actually evidenced based under uncertainty is whether you would follow the same policy if it was your own child. What? This makes no sense. How do you explain anti-vaxxer parents with this perspective? Parents may feel they know best, but feeling and fact have nothing to do with each other.

echelon 1y ago

> It’s not shameful, it’s how evidence based medicine works. Yeah, but I'll bet nothing happened as an outcome of this. No study, no communication to anyone else. That information probably just withered on the vine. I did a molecular bio undergrad and had classes with a bunch of pre-med students. They had zero interest in the science, just getting A's. They did care about appearance and money, driving cool cars, and dating hot partners. I know my experience is purely anecdotal and not indicative of all doctors, but I came away from my undergrad experience highly unimpressed with our medical feedstock. The only students in upper level electives that cared were the research-track students. I talk to my doctors regularly about medicinal chemistry and biochem -- they don't know anything. It's embrassing how little they retain or care.

calf 1y ago
"Evidence-based" is a really problematic term when it is used to protect bureaucracies and medical managerialism, rather than actually interact with scientific processes in an ethical way. Their anecdote is actually a good example of why evidence-based logic is not the end-all.
- uselesswords 1y ago
  [flagged]
  - echelon 1y ago
    Barry James Marshall
    - uselesswords 1y ago
      [flagged]
      - uselesswords 1y ago
        Since no one wants to explain and you I just got downvoted, Barry James Marshall is ironically an example of EBM and is HIMSELF an active proponent of EBM. He had a biological hypothesis that the scientific community disagreed with and tested it on himself for a case study to get data. That case study was successful and then became a clinical trial. That trial was replicated and shown to work. He then won a Nobel prize for that work and the risk he took. This is an evidence-based process. EBM doesn’t mean you disregard a N=1, it means you expand N=1 into N=10, then N=100,… before you apply something to the general population. This is loosely how phase-1,2,3,4 trials work in the US. Dismissing EBM because of Marshall is like dismissing all of math because someone disproved a popular conjecture like the local-to-global conjecture. Sure the community sentiment had it wrong, but the systematic logical approach of Math got it right. In Marshall’s case the community sentiment had it wrong, but the EBM approach eventually got it right. Half this thread doesn’t even know what they are arguing against.

teekert 1y ago

It is not shameful indeed. One never knows what the father had experienced if he had been given the therapy during the day. The oncologist could have written a paper (there are many single case papers), or started a trial by himself (requires a lot of organizing) if he was very intrigued. But of course one can’t do that for every above average case. I have to say, in this particular case there is a very plausible mechanism and the trial would not be that hard. So it is a real shame that nothing was done with this.

raylad 1y ago
Previous rounds of chemo were done on the normal morning infusion schedule and he ended up with a completely depleted immune system and was put in strict quarantine. He also got multiple infections that were life threatening. This is the reason I started looking into the alternate dosing schedule.

jcims 1y ago

Well the concept is now being studied quite closely. Had someone taken it seriously thirty years ago it's quite possible that the net amount of suffering that millions of patients have endured since then could have been reduced. https://pmc.ncbi.nlm.nih.gov/articles/PMC9599830/ https://pmc.ncbi.nlm.nih.gov/articles/PMC9599830/ I'm comfortable calling that shameful. Not on any one in particular, it's a systemic problem that could be reduced with sufficient tenacity and courage to take risks.

ch4s3 1y ago
There's limited time and a finite supply of doctors and researchers. They can't study everything that's promising all at once, and good ideas fall through the cracks all of the time.
- JamesSwift 1y ago
  I think this clears a bar of things that are useful and simple to study. Theres basically no effort involved. If it ends up beneficial we just update job postings from 'daytime infusion tech' to 'nighttime infusion tech'. Instant improvement in outcomes. I doubt you even need to clear this in any way to get the study greenlit.
  - jcims 1y ago
    Agreed. Scheduling is patient discretion anyway. It's the lowest bar possible as far as I can tell.
refurb 1y ago
> Had someone taken it seriously thirty years ago it's quite possible that the net amount of suffering that millions of patients have endured since then could have been reduced. You can only say that with hindsight because of the data over the past 30 years. What if the data showed the opposite? Then the doctor would have given his patients a worse outcome all on a "hunch".