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Primum non nocere (first, do no harm[1]) Medical research is conservative, cautious, and regulated because we strive to move beyond the ugly abuses of our past

Primum non nocere (first, do no harm[1]) Medical research is conservative, cautious, and regulated because we strive to move beyond the ugly abuses of our past[2]. It should not be the Wild West. For insight into modern medical ethics, read the Belmont Report[3]. It's what contemporary researchers must read before conducting any studies involving human subjects. Where I work, we're tested on it. (This is opinion, but...) Harm today is in research guided more by profit than by benefit. Chronic disease is more profitable than cures or prevention. With rapidly-emergent antibiotic resistance there is little private incentive to develop new antibiotics. We must rely on and expand research in the public interest (funded by NIH, philanthropy, and so on) to balance private biomedical research. 1. https://en.wikipedia.org/wiki/Primum_non_nocere https://en.wikipedia.org/wiki/Primum_non_nocere 2. https://en.wikipedia.org/wiki/List_of_medical_ethics_cases https://en.wikipedia.org/wiki/List_of_medical_ethics_cases 3. http://www.hhs.gov/ohrp/humansubjects/guidance/belmont.html http://www.hhs.gov/ohrp/humansubjects/guidance/belmont.html

burke 11y ago
> Primum non nocere As kauffj eludes to though, it's also worth considering the implicit harm done through inaction. It should not be the wild west, but conversely, articles like this are indicative of a bias toward increasing prevention of active, explicit harm at the expense of more unseen, implicit harm through inaction. As with anything, there's a happy medium.
- scarmig 11y ago
  A happy medium is good, but I'd say that that "medium" falls closer to the conservative side. A lot of the value of "First, do no harm" comes from the point that we have a bias toward action over inaction. Humans, including doctors, want the ability to control our futures. So the temptation is constantly to do something instead of saying "well, that sucks, but we don't have strong reason to believe anything we do will substantially improve things." That's why we perform way too many interventions (particularly, invasive and surgical ones) that at best marginally improve average outcomes at incredible cost and substantial risk. Doctor and patient both want a magic fix. And all too often the fix is more harmful than helpful to the individual patient, even if on average it might be slightly beneficial. Obviously there's a place for heroic surgical efforts and research into exotic drugs. But we over invest in those compared to the alternatives of prevention and palliation. Conservatism is useful in medicine.
  - burke 11y ago
    For sure. I don't have a strong opinion either way on whether medicine is too conservative or liberal right now, which probably means it falls within the happy medium ground for some reasonable definition. Mainly, I think it's worthwhile to point out what appears to be dogma on both sides of any debate.
  - bambax 11y ago
    There's a recent study [1] that shows that outcome for cardiac emergency patients are better (way better) when they're treated at a (good) hospital while the top cardiologists were away (at a conference). That is, patient outcome is better for patients who go to a hospital with a good reputation, that has outstanding doctors (a teaching hospital) -- but the outcome is best when the top doctors are NOT present in the hospital when the patient checks in. After controlling for many variables, the only explanation the authors of the study came up with to explain this apparent paradox, is that top doctors want to try anything, esp. the latest procedure/drug, while non-top doctors are more conservative. At least in the short term, being conservative saves lives. 1. https://hms.harvard.edu/news/startling-benefit-cardiology-meetings https://hms.harvard.edu/news/startling-benefit-cardiology-me...
  - JamesBarney 11y ago
    I don't think we need to group medicine as one thing that is too risk or conservative. We need to evaluate different branches of medicine. In the current culture, we have a bias to accept more risk from surgery than pharmaceuticals. Imagine you want to be appear more muscular. You could get implants under general anesthesia or you could take steroids. The first is legal, but the second is illegal. It is illegal because society deems that taking steroids is excessively risky. However general anesthesia and surgery are orders of magnitude more dangerous. This same bias present throughout medicine. Many surgical procedures and tests would never pass the FDA's requirements for pharmaceuticals.
kbenson 11y ago
It's entirely possible that medicine would still be conservative, cautious, and regulated after becoming less conservative, cautious and/or regulated, depending on it's starting state. It's important to regularly assess whether a policy is too conservative or not conservative enough, as it's trivial to show that neither extreme is as useful as the middle ground.
Confusion 11y ago
Conservatism and cautiousness can be ways of doing harm.
marcoperaza 11y ago
One thing is to be cautious in the medical advice you give to a patient. Another is to legally prohibit the patient from taking bigger risks. The idea that anyone but myself has authority over what goes into my body is absolutely ridiculous.
- travem 11y ago
  > The idea that anyone but myself has authority over what goes into my body is absolutely ridiculous. Casting this as a ridiculous argument completely ignores the viewpoint that there may well be externalities caused by this behavior that don't necessarily affect the individual but do affect other individuals. If we take as an example the consumption of illegal drugs the argument can be made that it should be the choice of the individual and not restricted by society, however there is a potential for significant costs (due to the behavior of the individual when under the influence of the drug) that are placed onto the society, thus the subsequent restrictions placed on the individuals. To be clear I am not intending to debate drug policy or be an apologist for the current war on drugs. My point is to illustrate that a perspective that considers the externalities of a behavior is not a ridiculous position to take as you assert.
  - marcoperaza 11y ago
    I'd say that drug prohibition is ridiculous. It's not only an attack on people's freedom, but also a boon to organized crime and terrorism. A lot of people are willing to pay a lot of money for the product, so if the government stops honest businesses from selling it, the guys with the guns will step in.
zacharytelschow 11y ago
So when the case of doing nothing is itself harmful (terminal cancer and the like), more risk isn't warranted?
- eanzenberg 11y ago
  Yes, considering you would still be liable for damages by the next of kin.
cobaltblue 11y ago
The entire thrust of our medical regulatory system, from the Flexner Report to today, is the belief that it's better for 1000 patients to die of neglect, than 1 from quackery. Until this irrational fear of quack medicine is cured, there will be no real progress in the field.[1] [1] https://news.ycombinator.com/item?id=3819346 https://news.ycombinator.com/item?id=3819346
- jkyle 11y ago
  > Until this irrational fear of quack medicine is cured, there will be no real progress in the field. Are you suggesting we've made "no real progress in the field" of medicine since 1910?
wyager 11y ago
Blindly applying "do no harm" to drug trials ignores opportunity cost. You can kill many thousands of people by delaying the release of a drug for a few months.
Lawtonfogle 11y ago
This seems to go back to the question of if inaction is an action (or if it counts as partial action). If acting causes harm, but stops greater harm, does it count as more or less harm than not acting? I've never seen a definite answer either way.
- Qantourisc 11y ago
  Depends on your values, if you go "cold hearted" and say each life is worth as much, the mathematics are rather simple. Add morality, religion, and philosophy to the mix, and you are out of luck.
Houshalter 11y ago
I'm really surprised that this is news, or that it's being upvoted on HN. Apparently deaths during trials are really rare. From the article: >A meta-analysis of non-cancer Phase 1 drug trials, published last year in The British Medical Journal, found serious adverse events in only 0.31 percent of participants, and no life-threatening events or deaths. And the last event comparable to this, according to the article, happened in 2006 in a different country. I was surprised by this. I would not have expected drug trials to be risk free, in fact I thought that was the whole point. Apparently they are already super conservative and safe. I'm not sure why people are alarmed or calling for more regulation. It's probably impossible to 100% safety, and certainly not desirable. Parent comment is definitely right that we kill more people through inaction and need to be far more liberal. Total lives saved is all that should matter. Somehow one person dying out of many drug trials over many years is news that's on the front page of HN. But the 22,000 people that died of cancer today isn't.
- Fomite 11y ago
  Part of the issue is, medically, we (where we = the medical community) killed those people, whereas cancer killed the other 22,000. Medical ethics are expressly meant to protect subjects from experimentation purely on the basis of "This will probably help more people than it hurts." Given the events that prompted the development of those guidelines, I'm not sure they're wrong.
  - selestify 11y ago
    > experimentation purely on the basis of "This will probably help more people than it hurts." And why is this bad?
    - Fomite 11y ago
      Because it very, very easily goes some very dark places, especially when you start talking about extreme risk to one person versus a diffuse benefit over several million.
      - 11y ago
vectorjohn 11y ago
You know the best way to "do no harm"? Do nothing. If you accept that doing nothing is, in fact, doing harm, then the comment you're replying to has a good point.
refurb 11y ago
Chronic disease is more profitable than cures or prevention. A ridiculous comment. What about the latest cure for HCV? It's been vastly more profitable for the company than any chronic treatment.
- Fomite 11y ago
  Or vaccines, which have a guaranteed market basically forever (or at least until eradication), and are an active part of many drug company's portfolios. It's a popular flippant statement, but it's not born out in fact.
- DrScump 11y ago
  Actually, that's a perfect example. Gilead offers a cure (well, now, two) for Hepatitis C, yet there is an uproar about the cost (US$60,000 and up). So, they are under a lot of pressure to drop the price severely and already charge much less outside the U.S. Now, contrast if they had made it a chronic treatment, needing dosing forever, and charged US$10K-15K/year. The media would have hardly bat an eyelash at that cost... and Gilead would have have made more money in the long run.

burke 11y ago

> Primum non nocere As kauffj eludes to though, it's also worth considering the implicit harm done through inaction. It should not be the wild west, but conversely, articles like this are indicative of a bias toward increasing prevention of active, explicit harm at the expense of more unseen, implicit harm through inaction. As with anything, there's a happy medium.

scarmig 11y ago
A happy medium is good, but I'd say that that "medium" falls closer to the conservative side. A lot of the value of "First, do no harm" comes from the point that we have a bias toward action over inaction. Humans, including doctors, want the ability to control our futures. So the temptation is constantly to do something instead of saying "well, that sucks, but we don't have strong reason to believe anything we do will substantially improve things." That's why we perform way too many interventions (particularly, invasive and surgical ones) that at best marginally improve average outcomes at incredible cost and substantial risk. Doctor and patient both want a magic fix. And all too often the fix is more harmful than helpful to the individual patient, even if on average it might be slightly beneficial. Obviously there's a place for heroic surgical efforts and research into exotic drugs. But we over invest in those compared to the alternatives of prevention and palliation. Conservatism is useful in medicine.
- burke 11y ago
  For sure. I don't have a strong opinion either way on whether medicine is too conservative or liberal right now, which probably means it falls within the happy medium ground for some reasonable definition. Mainly, I think it's worthwhile to point out what appears to be dogma on both sides of any debate.
- bambax 11y ago
  There's a recent study [1] that shows that outcome for cardiac emergency patients are better (way better) when they're treated at a (good) hospital while the top cardiologists were away (at a conference). That is, patient outcome is better for patients who go to a hospital with a good reputation, that has outstanding doctors (a teaching hospital) -- but the outcome is best when the top doctors are NOT present in the hospital when the patient checks in. After controlling for many variables, the only explanation the authors of the study came up with to explain this apparent paradox, is that top doctors want to try anything, esp. the latest procedure/drug, while non-top doctors are more conservative. At least in the short term, being conservative saves lives. 1. https://hms.harvard.edu/news/startling-benefit-cardiology-meetings https://hms.harvard.edu/news/startling-benefit-cardiology-me...
- JamesBarney 11y ago
  I don't think we need to group medicine as one thing that is too risk or conservative. We need to evaluate different branches of medicine. In the current culture, we have a bias to accept more risk from surgery than pharmaceuticals. Imagine you want to be appear more muscular. You could get implants under general anesthesia or you could take steroids. The first is legal, but the second is illegal. It is illegal because society deems that taking steroids is excessively risky. However general anesthesia and surgery are orders of magnitude more dangerous. This same bias present throughout medicine. Many surgical procedures and tests would never pass the FDA's requirements for pharmaceuticals.

kbenson 11y ago

It's entirely possible that medicine would still be conservative, cautious, and regulated after becoming less conservative, cautious and/or regulated, depending on it's starting state. It's important to regularly assess whether a policy is too conservative or not conservative enough, as it's trivial to show that neither extreme is as useful as the middle ground.

Confusion 11y ago

Conservatism and cautiousness can be ways of doing harm.

marcoperaza 11y ago

One thing is to be cautious in the medical advice you give to a patient. Another is to legally prohibit the patient from taking bigger risks. The idea that anyone but myself has authority over what goes into my body is absolutely ridiculous.

travem 11y ago
> The idea that anyone but myself has authority over what goes into my body is absolutely ridiculous. Casting this as a ridiculous argument completely ignores the viewpoint that there may well be externalities caused by this behavior that don't necessarily affect the individual but do affect other individuals. If we take as an example the consumption of illegal drugs the argument can be made that it should be the choice of the individual and not restricted by society, however there is a potential for significant costs (due to the behavior of the individual when under the influence of the drug) that are placed onto the society, thus the subsequent restrictions placed on the individuals. To be clear I am not intending to debate drug policy or be an apologist for the current war on drugs. My point is to illustrate that a perspective that considers the externalities of a behavior is not a ridiculous position to take as you assert.
- marcoperaza 11y ago
  I'd say that drug prohibition is ridiculous. It's not only an attack on people's freedom, but also a boon to organized crime and terrorism. A lot of people are willing to pay a lot of money for the product, so if the government stops honest businesses from selling it, the guys with the guns will step in.

zacharytelschow 11y ago

So when the case of doing nothing is itself harmful (terminal cancer and the like), more risk isn't warranted?

eanzenberg 11y ago
Yes, considering you would still be liable for damages by the next of kin.

cobaltblue 11y ago

The entire thrust of our medical regulatory system, from the Flexner Report to today, is the belief that it's better for 1000 patients to die of neglect, than 1 from quackery. Until this irrational fear of quack medicine is cured, there will be no real progress in the field.[1] [1] https://news.ycombinator.com/item?id=3819346 https://news.ycombinator.com/item?id=3819346

jkyle 11y ago
> Until this irrational fear of quack medicine is cured, there will be no real progress in the field. Are you suggesting we've made "no real progress in the field" of medicine since 1910?

wyager 11y ago

Blindly applying "do no harm" to drug trials ignores opportunity cost. You can kill many thousands of people by delaying the release of a drug for a few months.

Lawtonfogle 11y ago

This seems to go back to the question of if inaction is an action (or if it counts as partial action). If acting causes harm, but stops greater harm, does it count as more or less harm than not acting? I've never seen a definite answer either way.

Qantourisc 11y ago
Depends on your values, if you go "cold hearted" and say each life is worth as much, the mathematics are rather simple. Add morality, religion, and philosophy to the mix, and you are out of luck.

Houshalter 11y ago

I'm really surprised that this is news, or that it's being upvoted on HN. Apparently deaths during trials are really rare. From the article: >A meta-analysis of non-cancer Phase 1 drug trials, published last year in The British Medical Journal, found serious adverse events in only 0.31 percent of participants, and no life-threatening events or deaths. And the last event comparable to this, according to the article, happened in 2006 in a different country. I was surprised by this. I would not have expected drug trials to be risk free, in fact I thought that was the whole point. Apparently they are already super conservative and safe. I'm not sure why people are alarmed or calling for more regulation. It's probably impossible to 100% safety, and certainly not desirable. Parent comment is definitely right that we kill more people through inaction and need to be far more liberal. Total lives saved is all that should matter. Somehow one person dying out of many drug trials over many years is news that's on the front page of HN. But the 22,000 people that died of cancer today isn't.

Fomite 11y ago
Part of the issue is, medically, we (where we = the medical community) killed those people, whereas cancer killed the other 22,000. Medical ethics are expressly meant to protect subjects from experimentation purely on the basis of "This will probably help more people than it hurts." Given the events that prompted the development of those guidelines, I'm not sure they're wrong.
- selestify 11y ago
  > experimentation purely on the basis of "This will probably help more people than it hurts." And why is this bad?
  - Fomite 11y ago
    Because it very, very easily goes some very dark places, especially when you start talking about extreme risk to one person versus a diffuse benefit over several million.
    - 11y ago

vectorjohn 11y ago

You know the best way to "do no harm"? Do nothing. If you accept that doing nothing is, in fact, doing harm, then the comment you're replying to has a good point.

refurb 11y ago

Chronic disease is more profitable than cures or prevention. A ridiculous comment. What about the latest cure for HCV? It's been vastly more profitable for the company than any chronic treatment.

Fomite 11y ago
Or vaccines, which have a guaranteed market basically forever (or at least until eradication), and are an active part of many drug company's portfolios. It's a popular flippant statement, but it's not born out in fact.
DrScump 11y ago
Actually, that's a perfect example. Gilead offers a cure (well, now, two) for Hepatitis C, yet there is an uproar about the cost (US$60,000 and up). So, they are under a lot of pressure to drop the price severely and already charge much less outside the U.S. Now, contrast if they had made it a chronic treatment, needing dosing forever, and charged US$10K-15K/year. The media would have hardly bat an eyelash at that cost... and Gilead would have have made more money in the long run.