Interesting, thoughtful essay. I had previously considered "Primum non nocere" to signify a combination of non-maleficence (don't intentionally harm) and bias toward inaction when therapeutic course is unclear (don't unintentionally harm when you don't know what you are doing). Avoiding error and learning from error/adverse event is another important dimension.
Fascinating article. It brought to mind a notable quote from the Covid pandemic: “We’re never going to learn about how safe this vaccine is unless we start giving it. That’s just the way it goes.” That was from Dr. Eric Rubin (editor-in-chief of NEJM and a Harvard professor of Immunology and infectious disease) at a 10/26/2021 FDA Advisory Committee meeting on whether to give the Pfizer mRNA to children ages 5-11. That struck me at the time as a complete disregard of primum non nocere. But was there “non-maleficence” in the comment? Maleficence embodies INTENT to harm. So does “non-malifecence” allow disregard of first do no harm as long as there is no intent to harm? It has been my experience most patients expect their physician to proceed with error avoidance rather than error correction. Patients are not unlike airline passengers in that regard. I vote for recognizing there are uncertainties in medicine while we provide informed consent during the shared decision process while emphasizing primum non nocere rather than fallibility.
Interesting you cite Eric Rubin. It’s actually totally unsurprising he was fine with testing an experimental vaccine on the general public due to his inherent biases, given his long-time preoccupation with immunology and infectious disease as well as his professional status. His strong biases and his inability to step back from them surely meant he was subject to viewing things through a distorted lens. One may not call it an intent to harm, but certainly it was a lack of consideration or forethought with regards to potential harm.
Maybe doctors should have a ranked list of the four principles on their office door to reflect their practice philosophy. I would be looking for 1. Autonomy (with an emphasis on informed consent) 2. Justice 3. Non-nocere 4. Beneficence
Beneficence seems to go along with this overweening self-regard doctors have. I could use less of that.
If physicians were to regard themselves as the public regards them, they would lose all confidence whatsoever. You think the incidence of physician suicide is bad now?
Dr. Martin Makary, well known to this forum, published a study showing that in the United States, medical error ranks as the third leading cause associated with mortality—after cardiovascular disease and cancer. According to this, medicine is not only failing to solve the problem, it is actually becoming part of the problem.
It should be obvious that this is not solely attributable to physicians, but rather to the health system as a whole. “Error” in medicine is a complex construct encompassing a wide range of phenomena—from inappropriate behaviors resulting from false positives, false negatives, and overdiagnosis; to delayed diagnoses or treatments caused by systemic inefficiencies; to reckless interventions based on experience, logic-based assumptions, or extratheoretical interests—that is, decisions not centered on beneficence toward the human being, nor on the intricate relationship between the patient, their biopsychosocial context, and the healthcare environment.
That said, I understand Primum non nocere as the process by which, a priori, decisions are based on evaluating and balancing the effectiveness of an intervention against its risks—risks which, naturally, are inherent to any human-designed artificial intervention, whether at the individual or population level.
In theoretical terms, this means that the effectiveness of an intervention or preventive measure—after adjusting for prevalence and for the preferences of patients or communities where it will be introduced—must greatly exceed the adjusted risk of that same intervention in that particular context.
This theoretical “puzzle” has a practical tool we have been teaching for several years now: the Help-to-Harm Ratio. In concrete terms, it refers to the mathematical ratio between the adjusted NNT (Number Needed to Treat) and the adjusted NNH (Number Needed to Harm) for my patient or population. The decision to implement the intervention is justified only if this ratio does not exceed one.
Analogically, this is what allows us to prescribe—with peace of mind, while acknowledging the fallibility of our decision—Viagra to a patient with síndrome metabólico, o enfermedad coronaria preexistente o que usan nitratos (nitroglicerina, isosorbida), o riesgo de vegeta irreversible secundaria a neuropatía óptica isquémica anterior no arterítica (NOIA-NA), or indicar HPV vaccine to a celibate or monogamous woman with a family history of neurodegenerative disease.
Pd Si quiere “irse de para atrás” sobre el contenido de los juramentos hipocraticos en Norteamérica, revise por favor el artículo de Gamble y cols del 2015 “Swear by Thy Gracious Self’: North American Medical Oath-Taking in 2014/2015”
The writer generously allows that medical error "is not solely attributable to physicians." Unfortunately, the public and the press think otherwise. Why else would there be so-called "never events," things that should never happen and can only result from some horrible and punishable mistake? Unfortunately, reality being reality and humans being human, such events will happen from time to time, and not always due to avarice or negligence, but try telling that to the plaintiff's bar, the reporters, or the medical board. Physicians are more and more being held responsible for things that are beyond their control. Eventually, errors will be criminalized and reimbursement will be withheld unless the patient is completely cured. Imagine the doctor shortage then.
Perhaps we can agree that we are imperfect and therefore fallible, that we work sense-based Medicine, on probabilities rather than certainties, that everything we do is ultimately aimed at improving the well-being of our patients, and that “errors” arise from a confluence and interaction of factors related to the patient, the clinician, and the health ecosystem in which this interaction takes place.
I must confess that I have made many mistakes in my clinical practice—most of them due to premature diagnostic closure caused by mental fatigue, some even with fatal outcomes. Yet I have never been sued. In fact, in some of those cases, the families—while acknowledging the mistakes—have thanked me for the human care I provided.
I hold the view that, regardless of whether or not there is actual culpability in such errors, medico-legal claims tend to arise when, for whatever reason, the physician-patient relationship breaks down—when the patient or their loved ones realize that they were not truly at the center of their physician’s concern.
Although it is likely that these “soft” — yet profound — arguments may not hold much weight within the framework of the “defensive medicine” practiced almost everywhere today, and may not be sufficient to prevent lawsuits, I believe they are sensible enough for a judge or jury to understand — and to grasp their broader implications.
Now, the attributes I’ve described regarding my medical practice reflect my ethical framework—one that, at least in the United States, seems to have become so diluted that there no longer appears to be a clear, unified consensus about it.
As my sensei once said: “The day medical ethics is decided in courtrooms, and one needs lawyers in order to practice medicine, is the day we should leave medicine behind and start studying law.”
How odd no one else has given this a "like", perhaps confirming what I thought before and after reading most of these responses, i.e. the medical profession is heavily biased. This includes being biased towards others of their ilk, feeling that 'If I support one individual or group that's in trouble, I won't be supported should I ever face the same situation.' Wonder if that's why you've had no other likes.
New blood tests promise to detect malignancies before they’ve spread. But proving that these tests actually improve outcomes remains a stubborn challenge.
In recent New Yorker.
Always something new trying to reduce harm. My 40 year career was all about, to the best of my and my colleagues ability, to reduce harm
The problem with it is that everything we do carries risk of harm including doing nothing. Avoiding risk of harm in the absolute sense is impossible. Obviously, we must never intentioanlly harm, for example, by knowingly spreading false information or intentionally misusng VAERS data to alarm patients and discourage vaccination.
As for medical reversals, that is the goal of research. We should always strive to advance and refine our knowledge through ongoing research and to the extent that prior knowledge is "reversed" that is measure of success, not failure.
Fantastic article. Primum Errorem Quare proposes a more humane, more horizontal form of medicine. Trying to move from the doctor-patient relationship that has degenerated into a doctor-symptom relationship to a person-person relationship. Where hierarchy doesn't separate us or violate us. Thank you very much.
As person-as-patient my foundational principle is that I alone should decide what is the best option for me, making the inevitable tradeoffs myself, having been fully informed about them by my physician in a non-directive way that does not pre-empt/undermine my preferences under the guise of respecting some nebulous professional oath/code (or any other reason). I truly enjoy and benefit from Sensible (i.e. Bayesian) Medicine, but I can't recall the word 'preferences' ever being spoken, even when you (Adam, John and earlier Vinay) are discussing the tradeoff between the consequences of screening/diagnostic test error rates. Friendly enquiry: is this word in your (medical) vocabulary, and, if so, why does it not come naturally and routinely into your conversations and writings? Correction welcomed, of course.
"I am the one who determines what makes sense medically. My patients consider how my recommendations fit with their values, philosophy, and lifestyle. " I appreciate your obvious openness to debate/dissent, so I'll push a little. What makes sense to you (do we need 'medically'?) is what is in line with your risk/time/outcome preferences. The fact that in any specific case these preferences may be those of most/many doctors or guideline panels, most/many lay people - and may well be mine - does not affect their ontological status, or the ethical and legal principle that the relevant ones are fully in the patient's 'lane'. Regarding patients as having 'desires', rather than preferences, segues the SDM task away from being one of informing the patient, eliciting their informed preferences over the consequences of their (uncensored) options, and establishing what option that shared process 'recommends'. For avoidance of doubt I believe you are entitled to refuse to implement an option that you have deemed not OK/ not'sensible'/futile, but that will usually be at the expense of the clinical relaionship
You might take a look at my Substack! Started partly because 70 or so papers in PubMed have not achieved much - but to be honest I never expected them to!
ill push back a little. Physicians do not generally buy patient preferences as normative for us. The medical "move" (in contrast to small-l liberal politics) is to posit a divide (frequently) between patient preferences and patient (medical) interests. We see our job as nudging patient preferences toward their medical interests, even if we do not succeed. And we can be very directive where the contrast between the two is stark. That is our job.
Hi Tom. This looks like an own goal to me whatever one's politics. How do you/'we doctors doing our job' determine patient 'medical 'interests' without injecting preferences into the determination. Your preferences, your institution's, your disciplinary guideline panel's... it doesn't really matter. because you are very clear they are not the patient's preferences. In fact you talk as if only patients have preferences, 'medicine' itself is preference-free
I would like to second Jack here. Preferences, institutional and otherwise, abound. Insured patients are preferred over uninsured patients. Private insurance is preferred over Medicaid. Compliant patients are preferred over refuseniks. Simple patients are preferred over complex ones. The latter two preferences are often baked into the compensation structure for doctors by the grace of their employers' metrics. On and on. It's preferences all the way down not turtles.
In a sense, yes. Medicine is a practice; we learn it during training. yes, it has a web of norms and standards for what are good medical means and ends. These are not "preferences" in any individual sense--they are what constitutes "good medicine" or a good medical outcome as professionally determined. By the end of our training we possess this practice if our training has been successful. And it is what we do--again, if we're doing it right.
Interesting, thoughtful essay. I had previously considered "Primum non nocere" to signify a combination of non-maleficence (don't intentionally harm) and bias toward inaction when therapeutic course is unclear (don't unintentionally harm when you don't know what you are doing). Avoiding error and learning from error/adverse event is another important dimension.
Reach out to Dr William makis via email at makis78@yahoo.com he can get it shipped to you. Invermectin and fenbendazole
Fascinating article. It brought to mind a notable quote from the Covid pandemic: “We’re never going to learn about how safe this vaccine is unless we start giving it. That’s just the way it goes.” That was from Dr. Eric Rubin (editor-in-chief of NEJM and a Harvard professor of Immunology and infectious disease) at a 10/26/2021 FDA Advisory Committee meeting on whether to give the Pfizer mRNA to children ages 5-11. That struck me at the time as a complete disregard of primum non nocere. But was there “non-maleficence” in the comment? Maleficence embodies INTENT to harm. So does “non-malifecence” allow disregard of first do no harm as long as there is no intent to harm? It has been my experience most patients expect their physician to proceed with error avoidance rather than error correction. Patients are not unlike airline passengers in that regard. I vote for recognizing there are uncertainties in medicine while we provide informed consent during the shared decision process while emphasizing primum non nocere rather than fallibility.
Interesting you cite Eric Rubin. It’s actually totally unsurprising he was fine with testing an experimental vaccine on the general public due to his inherent biases, given his long-time preoccupation with immunology and infectious disease as well as his professional status. His strong biases and his inability to step back from them surely meant he was subject to viewing things through a distorted lens. One may not call it an intent to harm, but certainly it was a lack of consideration or forethought with regards to potential harm.
Core! ........... Sine qua, non !
Maybe doctors should have a ranked list of the four principles on their office door to reflect their practice philosophy. I would be looking for 1. Autonomy (with an emphasis on informed consent) 2. Justice 3. Non-nocere 4. Beneficence
Beneficence seems to go along with this overweening self-regard doctors have. I could use less of that.
If physicians were to regard themselves as the public regards them, they would lose all confidence whatsoever. You think the incidence of physician suicide is bad now?
Dr. Rolfhsen,
Dr. Martin Makary, well known to this forum, published a study showing that in the United States, medical error ranks as the third leading cause associated with mortality—after cardiovascular disease and cancer. According to this, medicine is not only failing to solve the problem, it is actually becoming part of the problem.
It should be obvious that this is not solely attributable to physicians, but rather to the health system as a whole. “Error” in medicine is a complex construct encompassing a wide range of phenomena—from inappropriate behaviors resulting from false positives, false negatives, and overdiagnosis; to delayed diagnoses or treatments caused by systemic inefficiencies; to reckless interventions based on experience, logic-based assumptions, or extratheoretical interests—that is, decisions not centered on beneficence toward the human being, nor on the intricate relationship between the patient, their biopsychosocial context, and the healthcare environment.
That said, I understand Primum non nocere as the process by which, a priori, decisions are based on evaluating and balancing the effectiveness of an intervention against its risks—risks which, naturally, are inherent to any human-designed artificial intervention, whether at the individual or population level.
In theoretical terms, this means that the effectiveness of an intervention or preventive measure—after adjusting for prevalence and for the preferences of patients or communities where it will be introduced—must greatly exceed the adjusted risk of that same intervention in that particular context.
This theoretical “puzzle” has a practical tool we have been teaching for several years now: the Help-to-Harm Ratio. In concrete terms, it refers to the mathematical ratio between the adjusted NNT (Number Needed to Treat) and the adjusted NNH (Number Needed to Harm) for my patient or population. The decision to implement the intervention is justified only if this ratio does not exceed one.
Analogically, this is what allows us to prescribe—with peace of mind, while acknowledging the fallibility of our decision—Viagra to a patient with síndrome metabólico, o enfermedad coronaria preexistente o que usan nitratos (nitroglicerina, isosorbida), o riesgo de vegeta irreversible secundaria a neuropatía óptica isquémica anterior no arterítica (NOIA-NA), or indicar HPV vaccine to a celibate or monogamous woman with a family history of neurodegenerative disease.
Pd Si quiere “irse de para atrás” sobre el contenido de los juramentos hipocraticos en Norteamérica, revise por favor el artículo de Gamble y cols del 2015 “Swear by Thy Gracious Self’: North American Medical Oath-Taking in 2014/2015”
The writer generously allows that medical error "is not solely attributable to physicians." Unfortunately, the public and the press think otherwise. Why else would there be so-called "never events," things that should never happen and can only result from some horrible and punishable mistake? Unfortunately, reality being reality and humans being human, such events will happen from time to time, and not always due to avarice or negligence, but try telling that to the plaintiff's bar, the reporters, or the medical board. Physicians are more and more being held responsible for things that are beyond their control. Eventually, errors will be criminalized and reimbursement will be withheld unless the patient is completely cured. Imagine the doctor shortage then.
Dear James,
Perhaps we can agree that we are imperfect and therefore fallible, that we work sense-based Medicine, on probabilities rather than certainties, that everything we do is ultimately aimed at improving the well-being of our patients, and that “errors” arise from a confluence and interaction of factors related to the patient, the clinician, and the health ecosystem in which this interaction takes place.
I must confess that I have made many mistakes in my clinical practice—most of them due to premature diagnostic closure caused by mental fatigue, some even with fatal outcomes. Yet I have never been sued. In fact, in some of those cases, the families—while acknowledging the mistakes—have thanked me for the human care I provided.
I hold the view that, regardless of whether or not there is actual culpability in such errors, medico-legal claims tend to arise when, for whatever reason, the physician-patient relationship breaks down—when the patient or their loved ones realize that they were not truly at the center of their physician’s concern.
Although it is likely that these “soft” — yet profound — arguments may not hold much weight within the framework of the “defensive medicine” practiced almost everywhere today, and may not be sufficient to prevent lawsuits, I believe they are sensible enough for a judge or jury to understand — and to grasp their broader implications.
Now, the attributes I’ve described regarding my medical practice reflect my ethical framework—one that, at least in the United States, seems to have become so diluted that there no longer appears to be a clear, unified consensus about it.
As my sensei once said: “The day medical ethics is decided in courtrooms, and one needs lawyers in order to practice medicine, is the day we should leave medicine behind and start studying law.”
Saving Grace.
Schara Verses Ascension Health Trial going on now with closing arguments in Wisconsin.Definitely a fail of the Medical Community I believe.
How odd no one else has given this a "like", perhaps confirming what I thought before and after reading most of these responses, i.e. the medical profession is heavily biased. This includes being biased towards others of their ilk, feeling that 'If I support one individual or group that's in trouble, I won't be supported should I ever face the same situation.' Wonder if that's why you've had no other likes.
The Catch in Catching Cancer Early
New blood tests promise to detect malignancies before they’ve spread. But proving that these tests actually improve outcomes remains a stubborn challenge.
In recent New Yorker.
Always something new trying to reduce harm. My 40 year career was all about, to the best of my and my colleagues ability, to reduce harm
Well said!
The problem with it is that everything we do carries risk of harm including doing nothing. Avoiding risk of harm in the absolute sense is impossible. Obviously, we must never intentioanlly harm, for example, by knowingly spreading false information or intentionally misusng VAERS data to alarm patients and discourage vaccination.
As for medical reversals, that is the goal of research. We should always strive to advance and refine our knowledge through ongoing research and to the extent that prior knowledge is "reversed" that is measure of success, not failure.
Excellent! I will share with faculty and students in College of Vet Med.
Beautifully written. Thank you !
Fantastic article. Primum Errorem Quare proposes a more humane, more horizontal form of medicine. Trying to move from the doctor-patient relationship that has degenerated into a doctor-symptom relationship to a person-person relationship. Where hierarchy doesn't separate us or violate us. Thank you very much.
As person-as-patient my foundational principle is that I alone should decide what is the best option for me, making the inevitable tradeoffs myself, having been fully informed about them by my physician in a non-directive way that does not pre-empt/undermine my preferences under the guise of respecting some nebulous professional oath/code (or any other reason). I truly enjoy and benefit from Sensible (i.e. Bayesian) Medicine, but I can't recall the word 'preferences' ever being spoken, even when you (Adam, John and earlier Vinay) are discussing the tradeoff between the consequences of screening/diagnostic test error rates. Friendly enquiry: is this word in your (medical) vocabulary, and, if so, why does it not come naturally and routinely into your conversations and writings? Correction welcomed, of course.
https://www.sensible-med.com/p/friday-reflection-34-disagreement
"I am the one who determines what makes sense medically. My patients consider how my recommendations fit with their values, philosophy, and lifestyle. " I appreciate your obvious openness to debate/dissent, so I'll push a little. What makes sense to you (do we need 'medically'?) is what is in line with your risk/time/outcome preferences. The fact that in any specific case these preferences may be those of most/many doctors or guideline panels, most/many lay people - and may well be mine - does not affect their ontological status, or the ethical and legal principle that the relevant ones are fully in the patient's 'lane'. Regarding patients as having 'desires', rather than preferences, segues the SDM task away from being one of informing the patient, eliciting their informed preferences over the consequences of their (uncensored) options, and establishing what option that shared process 'recommends'. For avoidance of doubt I believe you are entitled to refuse to implement an option that you have deemed not OK/ not'sensible'/futile, but that will usually be at the expense of the clinical relaionship
Sounds like the outline for a good essay! See the about page for submission guidelines.
You might take a look at my Substack! Started partly because 70 or so papers in PubMed have not achieved much - but to be honest I never expected them to!
Will do. Sounds like we’re here for the same reason. 😉
ill push back a little. Physicians do not generally buy patient preferences as normative for us. The medical "move" (in contrast to small-l liberal politics) is to posit a divide (frequently) between patient preferences and patient (medical) interests. We see our job as nudging patient preferences toward their medical interests, even if we do not succeed. And we can be very directive where the contrast between the two is stark. That is our job.
Hi Tom. This looks like an own goal to me whatever one's politics. How do you/'we doctors doing our job' determine patient 'medical 'interests' without injecting preferences into the determination. Your preferences, your institution's, your disciplinary guideline panel's... it doesn't really matter. because you are very clear they are not the patient's preferences. In fact you talk as if only patients have preferences, 'medicine' itself is preference-free
I would like to second Jack here. Preferences, institutional and otherwise, abound. Insured patients are preferred over uninsured patients. Private insurance is preferred over Medicaid. Compliant patients are preferred over refuseniks. Simple patients are preferred over complex ones. The latter two preferences are often baked into the compensation structure for doctors by the grace of their employers' metrics. On and on. It's preferences all the way down not turtles.
In a sense, yes. Medicine is a practice; we learn it during training. yes, it has a web of norms and standards for what are good medical means and ends. These are not "preferences" in any individual sense--they are what constitutes "good medicine" or a good medical outcome as professionally determined. By the end of our training we possess this practice if our training has been successful. And it is what we do--again, if we're doing it right.
Thank you Cory. Beautifully stated discussion.
Bravo. I would add that this maxim would benefit us all, as a daily intention or personal North Star…remember, nemo perfectus est!