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Ending Medical Reversal: Improving Outcomes, Saving Lives
We expect medicine to progress in an orderly fashion, with good medical practices being replaced by better ones. But some tests and therapies are discontinued because they are found to be worse, or at least no better, than what they replaced. Medications like Vioxx and procedures such as vertebroplasty for back pain caused by compression fractures are among the medical "advances" that turned out to be dangerous or useless. What Dr. Vinayak K. Prasad and Dr. Adam S. Cifu call medical reversal happens when doctors start using a medication, procedure, or diagnostic tool without a robust evidence base—and then stop using it when it is found not to help, or even to harm, patients.
Drs. Prasad and Cifu narrate fascinating stories from every corner of medicine to explore why medical reversals occur, how they are harmful, and what can be done to avoid them. They explore the difference between medical innovations that improve care and those that only appear to be promising. They also outline a comprehensive plan to reform medical education, research funding and protocols, and the process for approving new drugs that will ensure that more of what gets done in doctors’ offices and hospitals is truly effective.
346 pages, Kindle Edition
First published October 15, 2015
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March 4, 2016
The book divides roughly into three parts, a feature recognized by the authors in their notes between these parts. It is well organized and sign-posted, written in a way that is accessible to those outside of medicine and useful to those in the field. The boom represents one of best pieces of science and technology studies I've come across related to medical practice, and it is timely and written with a clear ethical problem and vision in mind.
The first section of the book is, no doubt, the most compelling. Prasad and Cifu (hereafter just P&C) have no doubt spent the most time thinking about and researching the evidence for the existence of medical reversal, which they identify as the phenomenon where a medical procedure will become standard of care despite inadequate evidence for its efficacy and the eventual turn against the procedure when it is found to be ineffective. It's hard to argue, after moving through the first six chapters, that P&C are wrong about medical reversal. The arguments they present are compelling, the promiscuity of cases across domains (e.g. medications, procedures, folk wisdom, hospital standards, etc.), and the implications of the reversals create a pretty much bulletproof case. For this reason, I want to focus more on the second and third parts.
The second part of the book argues that there is good reason to suppose that medical reversal represents a serious challenge to the medical community generally. In particular, it may be that a very large percentage (as much as 40%) of medical standards are not supported adequately and are subject to reversal. This argument is quite a bit thinner than the argument in the first part, and P&C acknowledge as much in their discussion. There are varied estimates, confounding variables, and serious methodological concerns about how to assess the body of medical standards of care.
My major concern in this section is that it may well be that the broad category of "medical reversal" actually subdivides into a few more fine-grained phenomena that might be more useful to P&C, as well as other sociologists of medicine and researchers. I don't have a really robust proposal here (and if I did, I would send it to P&C directly rather than publish it on Goodreads) but we might imagine that the various instances of causes of medical reversal cluster around two or three sets of errors, e.g. inadequate controls, sampling bias, irrelevant end points. implementation issues, etc. These clusters might be better treated relatively independently rather than as a single phenomenon, in order to achieve better results regarding.
This brings me to the third part of the book, in which P&C put forward a vision for reform in medical practice and education that they think would reduce medical reversal. I think that P&C make a good argument that the reforms they propose would work; they give good reasons to suppose it ought to work, but this is where the book makes a sort of serious mistake. P&C illustrate that one of the driving forces in medical reversal is the reliance on mechanistic explanation without generally controlled data focused on morbidity and mortality, the desired ends. By the argument they give for reforming medical education is similarly mechanistic without any attempt at establishing controls and focusing on the desired end points; I don't think this is a knockdown argument, because there is no way the sort of controlled data around medical education and desired outcomes exists, but I think that it would be wise for P&C to consider applying the general methodological considerations that (on their analysis) drive medical reversal and propose implementing studies that would satisfy those considerations for their educational program, to answer this recursive worry.
The first section of the book is, no doubt, the most compelling. Prasad and Cifu (hereafter just P&C) have no doubt spent the most time thinking about and researching the evidence for the existence of medical reversal, which they identify as the phenomenon where a medical procedure will become standard of care despite inadequate evidence for its efficacy and the eventual turn against the procedure when it is found to be ineffective. It's hard to argue, after moving through the first six chapters, that P&C are wrong about medical reversal. The arguments they present are compelling, the promiscuity of cases across domains (e.g. medications, procedures, folk wisdom, hospital standards, etc.), and the implications of the reversals create a pretty much bulletproof case. For this reason, I want to focus more on the second and third parts.
The second part of the book argues that there is good reason to suppose that medical reversal represents a serious challenge to the medical community generally. In particular, it may be that a very large percentage (as much as 40%) of medical standards are not supported adequately and are subject to reversal. This argument is quite a bit thinner than the argument in the first part, and P&C acknowledge as much in their discussion. There are varied estimates, confounding variables, and serious methodological concerns about how to assess the body of medical standards of care.
My major concern in this section is that it may well be that the broad category of "medical reversal" actually subdivides into a few more fine-grained phenomena that might be more useful to P&C, as well as other sociologists of medicine and researchers. I don't have a really robust proposal here (and if I did, I would send it to P&C directly rather than publish it on Goodreads) but we might imagine that the various instances of causes of medical reversal cluster around two or three sets of errors, e.g. inadequate controls, sampling bias, irrelevant end points. implementation issues, etc. These clusters might be better treated relatively independently rather than as a single phenomenon, in order to achieve better results regarding.
This brings me to the third part of the book, in which P&C put forward a vision for reform in medical practice and education that they think would reduce medical reversal. I think that P&C make a good argument that the reforms they propose would work; they give good reasons to suppose it ought to work, but this is where the book makes a sort of serious mistake. P&C illustrate that one of the driving forces in medical reversal is the reliance on mechanistic explanation without generally controlled data focused on morbidity and mortality, the desired ends. By the argument they give for reforming medical education is similarly mechanistic without any attempt at establishing controls and focusing on the desired end points; I don't think this is a knockdown argument, because there is no way the sort of controlled data around medical education and desired outcomes exists, but I think that it would be wise for P&C to consider applying the general methodological considerations that (on their analysis) drive medical reversal and propose implementing studies that would satisfy those considerations for their educational program, to answer this recursive worry.
November 6, 2019
A splendid book for all sorts of public with a very enjoyable style and presentation
Every doctor should read this and do a lot of soul searching
Every patient should read this to see what is from the other side of the table, you are counseled to do things that you may not understand but why? How are they sure? Why they seem to change their minds? Can I do something to sort these things out? (The book has a marvelous guide of of questions you should ask any doctor)
As a doctor I must say that this has been a strange journey
I learned very little from this book but for the reason that almost any idea I encountered I either had the same one or I had one in the back of my mind that never got ahead until I saw it here
Prasad and Cifu make the case that medical reversal, that is when a certain practice in medicine be it diagnostics treatment or prevention is proved to be of little use of even harmful, in science errors and corrections are welcomed but in medicine every error puts thousands if not millions at risk, is extremely common, up to a 40% of the total of medical practices are inadequate or based on poor information.
You may have heard of them, do a prostate test to prevent cancer becoming don't do that, it doesn't prevent prostate cancer, do a mammography when you are 40, NO! When you are 50.
May be you know someone who has a medical device inside them like a prothesis and then you hear scary news about all sorts of damages caused by them.
May be you know a diabetic that is constantly seeing contradictory advice about their glucose levels as in they should keep it low but then it won't prevent disease
Exposed are the multiple causes of medical reversal, most of them stem from what I call mental shortcuts.
Published evidence has all sorts of shortcomings that need special training to be aware of them but sadly medical education is severely lacking it. Medicine deals all the time with uncertainty, statistics is the method by wich uncertainty can be tamed so to speak and yet it is neglected and replaced by rules of thumb about p values and statistical significance (subjects that lead to wrong interpretations)
Not to mention the influence that pharmaceutical companies have on published evidence and the doctors that prescribe their treatments, don't take that as a anti industry manifest, it's one more of the factors to be aware all the time, in the frenzy to be ahead, because there is no rewaed to fact checkers or the second place and humans are always attracted to novelty shortcuts are taken by every party by making less than ideal studies that lead to biased results, no one is perfect, inadequate controls, sampling bias, irrelevant end points are all over the landscape of research.
P and C identify a central root that predisposes doctors to taking shortcuts in order to work, the faith in the fact they understand how the human body works and by doing so they can always find an justification to any treatment, this is knowledge is called the patophysiology of disease, the book is filles with examples that have the same cause, almost all medical reversals start as a good idea that makes sense according to what is known, and is carried about and proved right with evidence in the best of cases but when put to a stress test ideas differ from reality and there you have a contradiction, it made sense to keep sugar as low as possible in a diabetic but suddenly you see that things like heart infarctions don't diminish. This fact can take you blindsided because the results are only known after careful experimentation and observation, it would be almost impossible for a regular doctor to notice something as subtle as a 5% decrease or increase in the number of strokes, it escapes the capacity of a single mind without the help of record keeping and even then is difficult.
In essence doctors are primed from day one to create narratives according to what they now that make them comfortable when dealing with uncertainty, it's quite damaging if you ask me, it blinds you to where more truthful evidence lies.
Changes to the medical curriculum are proposed, they are only proposals but with them it is hoped that the mindset that allows medical reversal to be so pervasive becomes a thing from the past.
A must read.
Every doctor should read this and do a lot of soul searching
Every patient should read this to see what is from the other side of the table, you are counseled to do things that you may not understand but why? How are they sure? Why they seem to change their minds? Can I do something to sort these things out? (The book has a marvelous guide of of questions you should ask any doctor)
As a doctor I must say that this has been a strange journey
I learned very little from this book but for the reason that almost any idea I encountered I either had the same one or I had one in the back of my mind that never got ahead until I saw it here
Prasad and Cifu make the case that medical reversal, that is when a certain practice in medicine be it diagnostics treatment or prevention is proved to be of little use of even harmful, in science errors and corrections are welcomed but in medicine every error puts thousands if not millions at risk, is extremely common, up to a 40% of the total of medical practices are inadequate or based on poor information.
You may have heard of them, do a prostate test to prevent cancer becoming don't do that, it doesn't prevent prostate cancer, do a mammography when you are 40, NO! When you are 50.
May be you know someone who has a medical device inside them like a prothesis and then you hear scary news about all sorts of damages caused by them.
May be you know a diabetic that is constantly seeing contradictory advice about their glucose levels as in they should keep it low but then it won't prevent disease
Exposed are the multiple causes of medical reversal, most of them stem from what I call mental shortcuts.
Published evidence has all sorts of shortcomings that need special training to be aware of them but sadly medical education is severely lacking it. Medicine deals all the time with uncertainty, statistics is the method by wich uncertainty can be tamed so to speak and yet it is neglected and replaced by rules of thumb about p values and statistical significance (subjects that lead to wrong interpretations)
Not to mention the influence that pharmaceutical companies have on published evidence and the doctors that prescribe their treatments, don't take that as a anti industry manifest, it's one more of the factors to be aware all the time, in the frenzy to be ahead, because there is no rewaed to fact checkers or the second place and humans are always attracted to novelty shortcuts are taken by every party by making less than ideal studies that lead to biased results, no one is perfect, inadequate controls, sampling bias, irrelevant end points are all over the landscape of research.
P and C identify a central root that predisposes doctors to taking shortcuts in order to work, the faith in the fact they understand how the human body works and by doing so they can always find an justification to any treatment, this is knowledge is called the patophysiology of disease, the book is filles with examples that have the same cause, almost all medical reversals start as a good idea that makes sense according to what is known, and is carried about and proved right with evidence in the best of cases but when put to a stress test ideas differ from reality and there you have a contradiction, it made sense to keep sugar as low as possible in a diabetic but suddenly you see that things like heart infarctions don't diminish. This fact can take you blindsided because the results are only known after careful experimentation and observation, it would be almost impossible for a regular doctor to notice something as subtle as a 5% decrease or increase in the number of strokes, it escapes the capacity of a single mind without the help of record keeping and even then is difficult.
In essence doctors are primed from day one to create narratives according to what they now that make them comfortable when dealing with uncertainty, it's quite damaging if you ask me, it blinds you to where more truthful evidence lies.
Changes to the medical curriculum are proposed, they are only proposals but with them it is hoped that the mindset that allows medical reversal to be so pervasive becomes a thing from the past.
A must read.
April 20, 2020
• "Ending Medical Reversal" is an essential book for medical students, physicians, and anyone even peripherally involved in medicine; for everybody else, it's merely highly recommended. The core of the book, paraphrasing, is that sometimes physicians decide to do things to patients without great evidence. These practices are, later on, 'reversed' by well-done trials, often to the great surprise of thought leaders and experts in a specialty. This is "Medical Reversal", which doesn't sound all too exciting, but is actually super important.
• To understand why, the underpinnings of the evidence-based medicine community need to be examined. The most important of them is the following: medical theory, in the sense of scientific models that allow for accurate prediction of real-world outcomes, is very poor. Another way of saying this: biology is very complex, and predicting real-world outcomes in biological systems with any precision is mostly impossible.
• The second most important assumption is that the vast majority of modern medical interventions, even when they do work, have modest effect sizes. A new cancer drug, if you're lucky, might increase survival by an average of a month, a new weight loss drug might let you lose another 5-10 lbs, and a surgery might save 79% of patients instead of 77%. These are made-up numbers, but the point stands: on average, when new drugs works, which is itself rare, they tend to be incremental improvements over the old standard of care.
• There are exceptions, but they're rare in the modern era: for instance, you didn't need RCT's to see that antiseptic techniques improves surgery, because the effect sizes were enormous-- for instance, operating on the peritoneum, previously a death sentence, became possible. Amputation mortality rates fell by more than 50%. The effects were so powerful they could be seen with practically any study design.
• The third tenet of EBM is that most interventions, even the best funded and most plausible candidates, fail when tested in the real world. As the authors put in their book, this means that the prior probability of any given intervention working is very low, even in the late phases of drug development. This has implications for the types of evidence that physicians should require to shift their guess on whether a given drug works. Importantly, developing medical interventions is incredibly hard and expensive, and seems to be getting harder over time, giving rise to the reverse Moore's Law that has been termed "Eroom's Law" (incidentally, this may have reversed slightly in the last decade but this is a preliminary finding).
• As a result of these 3 factors, to really know if a medical intervention is effective, you need randomized controlled trials where the effects of a single intervention are tested on roughly similar groups of patients and outcomes are tracked in a rigorous manner. RCT's are onerous, slow, and require immense coordination-- but they've overturned many pet theories and biologically plausible interventions. The fact that these theories and interventions turn out to not work is not the problem-- after all, false starts and experimentation are how science progresses-- the problem is that they're often implemented prematurely, before rigorous testing, and only later, as doubt builds, are they truly tested.
• This is "Medical Reversal". There are other important arguments in the book, but they're mostly subsidiary to these 3 key arguments. Among them is a critique of surrogate endpoints, criticism of sloppily and hastily implemented 'systemic' interventions in hospital systems, the profusion of observational studies purporting to show harmful or beneficial effects of lifestyle factors, and the supplement industry.
• There's a more radical part of the book, which I think is underappreciated: the call to action in the later half of the book. The authors argue for a new era in medicine, wherein a large fraction of patients will be enrolled in RCT's, constantly testing medical dogma, even for simple questions that are currently poorly understood. They want an easier and more seamless way to recruit patients in clinical trials, which would be done at lower cost than current methods, and think this can be done partly by viewing RCT's as the default.
• Any practice in medicine that is currently understudied would be subject to this "RCT by default, opt out if you want" framework. Since RCT's would be testing treatments that are, theoretically, in equipoise, this is far more ethical than our current era, in which many medical interventions are only tested rigorously AFTER being used on patients in uncontrolled settings. As they correctly point out, #quotes the "safest way to receive a new drug is in a trial with a control arm. The randomized-controlled-trial design provides a built-in safeguard—trials are stopped if the treatment turns out to be harmful".
• As they acknowledge, this radical change is a big ask, but "evidence-based medicine...is the only rational way to provide care" and in my view, is the only ethical way to practice medicine.
• Later in the book they critique medical education for it's elevation of purported drug mechanisms and biological minutiae over a better understanding of medical evidence, landmark clinical trials, and more contact with patients in clinical settings. They call for an overhaul of medical education. A nice quote on this: "The primacy of the basic sciences is the reason that cardiologists could not accept the finding that niacin did not save lives. It is why radiologists could not accept that vertebroplasty did not help back pain. It is the reason orthopedists could not accept that repairing torn menisci did not help knee pain."
• The book isn't perfect. There are some relatively minor factual stumbles which don't affect the core arguments.
• For example, it uncritically cites "Nudge" by Sunstein and Thaler, which is based in large part on Behavioral Economics-- but at least some of that work has not fared well in the replication crisis, as Kahneman himself has pointed out in a blog post. So that's pretty ironic.
• I also think its deceptive to say that supplements don't have to admit to a lack of evidence, as they claim. They do. Every supplement I've ever purchased has had, in clear writing, "This product is not approved....to treat or prevent any disease". Of course, these same supplement bottles claim benefits, so its a mixed message, but supplements certainly have labeling to indicate they're not approved.
• The authors also repeatedly criticize pharma-funded trials and influence, but my understanding is that pharma-funded trials generally comply with reporting regulations better than academia funded trials, and may, in fact, be more trustworthy than the average academic study.
• Then there are the ideological disagreements I have with the book. I wonder what the authors would think of cosmetic surgery when they write "The list of medical practices that improve outcomes among healthy individuals is a very short one." They're right about medical outcomes, but individuals have goals besides health, and cosmetic surgery can occasionally help achieve those goals.
• In regards to supplements, individuals often have goals besides health as well: performance in the gym, aesthetics, etc. There are a small handful of supplements with RCT evidence of efficacy: creatine is probably the best example. It works pretty reliably, though with a modest effect, on increasing muscular endurance and likely muscle growth. Caffeine is another example. Both are used by millions, with very good safety profiles. Would the authors propose that all non-medical usage of supplements be banned? I would love to hear their thoughts on that. More controversially, plenty of people would make trade-offs between quality of life and lifespan. How would a clinical trial be run on these questions? They could theoretically be done, but as it stands I think any trial that, for instance, allowed healthy middle-aged men access to exogenous testosterone in supraphysiological doses, would struggle to get run.
• Cosmetic surgery and supplement use for non-medical purposes both push on an interesting corner of their argument: freedom. For the clinical trial infrastructure to work, participating in a trial has to be the main way that drugs get approved and patients get access to experimental medications. If alternative pathways to drugs are available in large numbers, and enrollment in trials is threatened, this whole RCT structure falls apart. Medical freedom is not exactly compatible with "RCT's for all".
• To their credit, the authors sort of touch on this: they focus on the pull side of RCT incentives-- if clinical trials are much easier to run, if inclusion criteria for new drugs were not so strict, if many more patients were enrolled, etc. then patients would have much fewer incentives to try to get drugs outside of approved protocols. And yet, with urine and blood testing of drugs, medical tourism, and patients sharing information about side effects with each other over social media, it is becoming increasingly possible for patients to figure out who is in a control/experimental arm and get drugs outside of approved channels. These are real threats to RCT's, and I'm very curious what the authors think of these developments.
• My final disagreement is with optimism in medicine. I'm not even sure the authors would disagree with this, since they're not really aiming their critique at drug researchers per se, but just in case: while drugs with large effect sizes are rare in medicine, they're not unknown. In the modern era, perhaps only HIV and Hep-C drugs, along with immunotherapy in some cancers and Gleevec meet this benchmark of large effect sizes. While most medicines will be incremental advances of the state of the art, I hope we continue looking for moonshots. We should be properly skeptical of anybody who claims to have found one, but rejoice if a good RCT shows them to be right. Expect failure or incremental advance, rejoice when we're wrong!
• Overall, I can't recommend this book enough. 5/5.
• To understand why, the underpinnings of the evidence-based medicine community need to be examined. The most important of them is the following: medical theory, in the sense of scientific models that allow for accurate prediction of real-world outcomes, is very poor. Another way of saying this: biology is very complex, and predicting real-world outcomes in biological systems with any precision is mostly impossible.
• The second most important assumption is that the vast majority of modern medical interventions, even when they do work, have modest effect sizes. A new cancer drug, if you're lucky, might increase survival by an average of a month, a new weight loss drug might let you lose another 5-10 lbs, and a surgery might save 79% of patients instead of 77%. These are made-up numbers, but the point stands: on average, when new drugs works, which is itself rare, they tend to be incremental improvements over the old standard of care.
• There are exceptions, but they're rare in the modern era: for instance, you didn't need RCT's to see that antiseptic techniques improves surgery, because the effect sizes were enormous-- for instance, operating on the peritoneum, previously a death sentence, became possible. Amputation mortality rates fell by more than 50%. The effects were so powerful they could be seen with practically any study design.
• The third tenet of EBM is that most interventions, even the best funded and most plausible candidates, fail when tested in the real world. As the authors put in their book, this means that the prior probability of any given intervention working is very low, even in the late phases of drug development. This has implications for the types of evidence that physicians should require to shift their guess on whether a given drug works. Importantly, developing medical interventions is incredibly hard and expensive, and seems to be getting harder over time, giving rise to the reverse Moore's Law that has been termed "Eroom's Law" (incidentally, this may have reversed slightly in the last decade but this is a preliminary finding).
• As a result of these 3 factors, to really know if a medical intervention is effective, you need randomized controlled trials where the effects of a single intervention are tested on roughly similar groups of patients and outcomes are tracked in a rigorous manner. RCT's are onerous, slow, and require immense coordination-- but they've overturned many pet theories and biologically plausible interventions. The fact that these theories and interventions turn out to not work is not the problem-- after all, false starts and experimentation are how science progresses-- the problem is that they're often implemented prematurely, before rigorous testing, and only later, as doubt builds, are they truly tested.
• This is "Medical Reversal". There are other important arguments in the book, but they're mostly subsidiary to these 3 key arguments. Among them is a critique of surrogate endpoints, criticism of sloppily and hastily implemented 'systemic' interventions in hospital systems, the profusion of observational studies purporting to show harmful or beneficial effects of lifestyle factors, and the supplement industry.
• There's a more radical part of the book, which I think is underappreciated: the call to action in the later half of the book. The authors argue for a new era in medicine, wherein a large fraction of patients will be enrolled in RCT's, constantly testing medical dogma, even for simple questions that are currently poorly understood. They want an easier and more seamless way to recruit patients in clinical trials, which would be done at lower cost than current methods, and think this can be done partly by viewing RCT's as the default.
• Any practice in medicine that is currently understudied would be subject to this "RCT by default, opt out if you want" framework. Since RCT's would be testing treatments that are, theoretically, in equipoise, this is far more ethical than our current era, in which many medical interventions are only tested rigorously AFTER being used on patients in uncontrolled settings. As they correctly point out, #quotes the "safest way to receive a new drug is in a trial with a control arm. The randomized-controlled-trial design provides a built-in safeguard—trials are stopped if the treatment turns out to be harmful".
• As they acknowledge, this radical change is a big ask, but "evidence-based medicine...is the only rational way to provide care" and in my view, is the only ethical way to practice medicine.
• Later in the book they critique medical education for it's elevation of purported drug mechanisms and biological minutiae over a better understanding of medical evidence, landmark clinical trials, and more contact with patients in clinical settings. They call for an overhaul of medical education. A nice quote on this: "The primacy of the basic sciences is the reason that cardiologists could not accept the finding that niacin did not save lives. It is why radiologists could not accept that vertebroplasty did not help back pain. It is the reason orthopedists could not accept that repairing torn menisci did not help knee pain."
• The book isn't perfect. There are some relatively minor factual stumbles which don't affect the core arguments.
• For example, it uncritically cites "Nudge" by Sunstein and Thaler, which is based in large part on Behavioral Economics-- but at least some of that work has not fared well in the replication crisis, as Kahneman himself has pointed out in a blog post. So that's pretty ironic.
• I also think its deceptive to say that supplements don't have to admit to a lack of evidence, as they claim. They do. Every supplement I've ever purchased has had, in clear writing, "This product is not approved....to treat or prevent any disease". Of course, these same supplement bottles claim benefits, so its a mixed message, but supplements certainly have labeling to indicate they're not approved.
• The authors also repeatedly criticize pharma-funded trials and influence, but my understanding is that pharma-funded trials generally comply with reporting regulations better than academia funded trials, and may, in fact, be more trustworthy than the average academic study.
• Then there are the ideological disagreements I have with the book. I wonder what the authors would think of cosmetic surgery when they write "The list of medical practices that improve outcomes among healthy individuals is a very short one." They're right about medical outcomes, but individuals have goals besides health, and cosmetic surgery can occasionally help achieve those goals.
• In regards to supplements, individuals often have goals besides health as well: performance in the gym, aesthetics, etc. There are a small handful of supplements with RCT evidence of efficacy: creatine is probably the best example. It works pretty reliably, though with a modest effect, on increasing muscular endurance and likely muscle growth. Caffeine is another example. Both are used by millions, with very good safety profiles. Would the authors propose that all non-medical usage of supplements be banned? I would love to hear their thoughts on that. More controversially, plenty of people would make trade-offs between quality of life and lifespan. How would a clinical trial be run on these questions? They could theoretically be done, but as it stands I think any trial that, for instance, allowed healthy middle-aged men access to exogenous testosterone in supraphysiological doses, would struggle to get run.
• Cosmetic surgery and supplement use for non-medical purposes both push on an interesting corner of their argument: freedom. For the clinical trial infrastructure to work, participating in a trial has to be the main way that drugs get approved and patients get access to experimental medications. If alternative pathways to drugs are available in large numbers, and enrollment in trials is threatened, this whole RCT structure falls apart. Medical freedom is not exactly compatible with "RCT's for all".
• To their credit, the authors sort of touch on this: they focus on the pull side of RCT incentives-- if clinical trials are much easier to run, if inclusion criteria for new drugs were not so strict, if many more patients were enrolled, etc. then patients would have much fewer incentives to try to get drugs outside of approved protocols. And yet, with urine and blood testing of drugs, medical tourism, and patients sharing information about side effects with each other over social media, it is becoming increasingly possible for patients to figure out who is in a control/experimental arm and get drugs outside of approved channels. These are real threats to RCT's, and I'm very curious what the authors think of these developments.
• My final disagreement is with optimism in medicine. I'm not even sure the authors would disagree with this, since they're not really aiming their critique at drug researchers per se, but just in case: while drugs with large effect sizes are rare in medicine, they're not unknown. In the modern era, perhaps only HIV and Hep-C drugs, along with immunotherapy in some cancers and Gleevec meet this benchmark of large effect sizes. While most medicines will be incremental advances of the state of the art, I hope we continue looking for moonshots. We should be properly skeptical of anybody who claims to have found one, but rejoice if a good RCT shows them to be right. Expect failure or incremental advance, rejoice when we're wrong!
• Overall, I can't recommend this book enough. 5/5.
December 26, 2018
While in the early stages of my career,* before even starting my undergraduate degree, I worked as a phlebotomist and medical assistant and spent much of my time off immersed in the skeptics community - reading and talking about the never-ending debunkings of (often mechanistically implausible) interventions like homeopathy and reiki, and infuriated by the regulatory failures that contribute to this robust industry. These are indeed concerns worth addressing, but the more time I spent in the community the more I found myself disheartened by its most popular collective blindspots. Many (of course not all) skeptics readily railed against alternative practitioners while gesturing vaguely at a supposedly evidence-based system they left largely unexamined. Meanwhile, increasingly involved in the provision of healthcare, I started critically appraising the decisions being made around me and began to understand, to my horror, the depth of what we do not know - and perhaps more damningly, what we know and ignore.
Fast forward about five or six years. I picked up this book after stumbling upon a wonderful and succinct journal article from 2011 by Drs. Prasad and Cifu, also on the subject of medical reversal (https://www.ncbi.nlm.nih.gov/pmc/arti...).
I am always thrilled to find healthcare providers who do the hard work of questioning their own dogma (as opposed to the dogma of others) and this book does an excellent job of that. In fact while I was reading it I felt compelled to take notes specifically because it provides (especially in the first three parts) such a well-laid-out - and well-sourced - summary of the thoughts and feelings I've had swimming around my head and slowly taking shape in that intervening time period. I predict these notes will prove handy for guiding my ongoing discussions with colleagues.
Aside from a few minor editorial changes I would make, my main quibble with the book is that at times I wish it had gotten more into the weeds in discussing specific reversals, and perhaps incorporated more of the appendix-ed examples into the main text, but I understand why such choices were made in terms of maintaining the appeal for both lay and professional audiences as well as keeping the book to an easily digested length.
This last paragraph is a bit of an aside, but I also feel compelled to note that my feelings on the alternative practices so heavily scorned by skeptics have changed somewhat over time. This is not to say that I now believe in interventions for which RCTs suggest no effect (I don't), but I do think that understanding the context of patient decisions is much more complex and worthy of consideration than the skeptics community tends to give it credit for being. The skeptics community (not always the public figures but often the community at large) seems to encourage a harsh response to anyone who chooses such therapies with no consideration of literacy/education (and the influencing social factors), desperation, culture, legitimately terrible personal and/or intergenerational interactions with the "western" healthcare system... and so on. Not to mention the therapeutic draw of providers willing/able (of course there are major system constraints for most providers) to spend lots of time with patients, especially time listening. Finally, and somewhat controversially, I have come to the conclusion that some degree of inclusion of alternative care can be a form of harm reduction in cases where the patient would otherwise not access any care whatsoever.
*I am still in the early stages, truly.
Fast forward about five or six years. I picked up this book after stumbling upon a wonderful and succinct journal article from 2011 by Drs. Prasad and Cifu, also on the subject of medical reversal (https://www.ncbi.nlm.nih.gov/pmc/arti...).
I am always thrilled to find healthcare providers who do the hard work of questioning their own dogma (as opposed to the dogma of others) and this book does an excellent job of that. In fact while I was reading it I felt compelled to take notes specifically because it provides (especially in the first three parts) such a well-laid-out - and well-sourced - summary of the thoughts and feelings I've had swimming around my head and slowly taking shape in that intervening time period. I predict these notes will prove handy for guiding my ongoing discussions with colleagues.
Aside from a few minor editorial changes I would make, my main quibble with the book is that at times I wish it had gotten more into the weeds in discussing specific reversals, and perhaps incorporated more of the appendix-ed examples into the main text, but I understand why such choices were made in terms of maintaining the appeal for both lay and professional audiences as well as keeping the book to an easily digested length.
This last paragraph is a bit of an aside, but I also feel compelled to note that my feelings on the alternative practices so heavily scorned by skeptics have changed somewhat over time. This is not to say that I now believe in interventions for which RCTs suggest no effect (I don't), but I do think that understanding the context of patient decisions is much more complex and worthy of consideration than the skeptics community tends to give it credit for being. The skeptics community (not always the public figures but often the community at large) seems to encourage a harsh response to anyone who chooses such therapies with no consideration of literacy/education (and the influencing social factors), desperation, culture, legitimately terrible personal and/or intergenerational interactions with the "western" healthcare system... and so on. Not to mention the therapeutic draw of providers willing/able (of course there are major system constraints for most providers) to spend lots of time with patients, especially time listening. Finally, and somewhat controversially, I have come to the conclusion that some degree of inclusion of alternative care can be a form of harm reduction in cases where the patient would otherwise not access any care whatsoever.
*I am still in the early stages, truly.
January 5, 2016
I was asked to review this from the Nursing Times Journal
Title: Ending Medical Reversal
Author: V Prasad and S Adam
Publisher: Johns Hopkins University Press, 2015
Description:
This is essentially a huge request for evidence based medicine by the authors. As a nurse I am aware through literature that practices are still undertaken that are futile for patients. We are aware that practices and medications are fashionable then go out of fashion depending on “research” at the time. From my experience of a relative an Oncologist who was unaware of their past medical history bombarded them with a first dose of chemotherapy that resulted in an admission to A&E in per arrest. Some may argue this was a chance to give them more time – but at what cost.
Point to be aware of is that, not everything the medical profession does is not all bad practice; some of the book may well be anecdotal. Sometimes practitioners have to act on the recommendations at that time and hindsight is a great thing.
Highlights:
The authors investigate where something went wrong and how this occurred suggesting where things could be carried out differently. Research at that time may not have had good or reasonable sample sizes the study may have had flaws. One has to appreciate drug companies are involved in treatments too.
We have seen so often reversal practices to prolong life in patients, when we look back on the research it was flawed.
Morbidity and mortality rates are an aspect the medical profession continually look at but there are so many strands to this.
Strengths and weaknesses:
The authors give good arguments and back up there hypothesis with research and reference their material well.
The book is written in a reader friendly manner in that the public will understand what is written and not just the nursing and medical profession.
The reader must ensure that they do not stop a treatment because they have read this book this must be looked into and involve good practice and leadership skills- there is no harm in consulting senior colleagues – more harm to patients if this is ignored.
Potential Readers:
This has to be on the reading list for medical and nursing students. This for the reader is an aspect of care that cannot be ignored and for the health care profession to keep striving for evidence based practice and not the old adage “we have always done it this way”
Title: Ending Medical Reversal
Author: V Prasad and S Adam
Publisher: Johns Hopkins University Press, 2015
Description:
This is essentially a huge request for evidence based medicine by the authors. As a nurse I am aware through literature that practices are still undertaken that are futile for patients. We are aware that practices and medications are fashionable then go out of fashion depending on “research” at the time. From my experience of a relative an Oncologist who was unaware of their past medical history bombarded them with a first dose of chemotherapy that resulted in an admission to A&E in per arrest. Some may argue this was a chance to give them more time – but at what cost.
Point to be aware of is that, not everything the medical profession does is not all bad practice; some of the book may well be anecdotal. Sometimes practitioners have to act on the recommendations at that time and hindsight is a great thing.
Highlights:
The authors investigate where something went wrong and how this occurred suggesting where things could be carried out differently. Research at that time may not have had good or reasonable sample sizes the study may have had flaws. One has to appreciate drug companies are involved in treatments too.
We have seen so often reversal practices to prolong life in patients, when we look back on the research it was flawed.
Morbidity and mortality rates are an aspect the medical profession continually look at but there are so many strands to this.
Strengths and weaknesses:
The authors give good arguments and back up there hypothesis with research and reference their material well.
The book is written in a reader friendly manner in that the public will understand what is written and not just the nursing and medical profession.
The reader must ensure that they do not stop a treatment because they have read this book this must be looked into and involve good practice and leadership skills- there is no harm in consulting senior colleagues – more harm to patients if this is ignored.
Potential Readers:
This has to be on the reading list for medical and nursing students. This for the reader is an aspect of care that cannot be ignored and for the health care profession to keep striving for evidence based practice and not the old adage “we have always done it this way”
February 24, 2018
This is a provocative review of the many medical procedures that have been "reversed". The title, "Ending Medical Reversal" refers to a phenomenon in medicine where procedures and medications previously accepted as efficacious are proved to be useless or harmful. Some of the examples referred to are mammograms for detecting breast cancer and the PSA test for detecting prostate cancer. The authors refer to many more in the book.
The problem is that too many medical practices are approved for use by the profession that have not been tested by well designed research. The authors describe good research and bad research tests in very understandable language. They then discuss how medical education should be changed so that practitioners are better able to discern good research before putting medical approaches into practice. A boring section unless you care about what should learned in first year or third year medical school. Finally the authors propose a change in the environment of day-to-day medicine where patients are encouraged to join small and quick research trials to test out various procedures, medications, and devices.
Taken as a whole this book has a very narrow audience - the medical profession. For me the most interesting is the first part of the book where the authors rehearse the various things that have been reversed and why it matters. We waste money on useless or harmful procedures and we could do a better job in improving people's lives.
The problem is that too many medical practices are approved for use by the profession that have not been tested by well designed research. The authors describe good research and bad research tests in very understandable language. They then discuss how medical education should be changed so that practitioners are better able to discern good research before putting medical approaches into practice. A boring section unless you care about what should learned in first year or third year medical school. Finally the authors propose a change in the environment of day-to-day medicine where patients are encouraged to join small and quick research trials to test out various procedures, medications, and devices.
Taken as a whole this book has a very narrow audience - the medical profession. For me the most interesting is the first part of the book where the authors rehearse the various things that have been reversed and why it matters. We waste money on useless or harmful procedures and we could do a better job in improving people's lives.
February 9, 2017
I added this book to my reading list after it was referenced in a December 8, 2016 Freakonomics podcast titled "Bad Medicine: Drug Trials and Tribulations", about when an established treatment is overturned as ineffective or even harmful. Although it was slightly more academic than my typical fare, I did enjoy the read and the perspective of evidence-based medicine and the need for controlled scientific studies, in conjunction and/or contrast with observational methods. If anything, it helped me understand why some practice of medicine seems to be an art, without clear and rigid guidelines on diagnosis and/or treatment methods.
December 9, 2015
Three and a half stars. The examples of how we are harmed by accepted but unproven therapies was a fascinating cautionary tale. But the last few chapters, which suggested strategies for ending unproven medical therapies, was perhaps less useful to the lay-public.
July 29, 2018
This book opened my eyes to the importance of having evidence-based medical care. You might be surprised to know this, but the vast majority of decisions made by physicians are not based on solid evidence. Even widely held beliefs are later shown to have no benefit or are proven to be actually harmful. Before the invention of the randomized controlled trials (RCT) in the mid 20th century, there really wasn't a way to rigorously test whether or not an intervention actually worked in reducing morbidity or mortality. People for centuries, even to this day, have relied on hunches, tradition, or misleading biochemical explanations to guide their decisions.
The problem arises because no matter how well we might understand a particular mechanism of a drug or implant, no matter how much an intervention might make sense, the reality is that "the human body is so complicated, and our understanding of it so superficial, that what we believe should work often does not." (p.166).
The first part of the book is a survey of modern reversals in the past several decades (treatments that are adopted without evidence and later withdrawn). The list here includes coronary stents, vertebroplasty, estrogen replacement therapy, breast and prostate cancer screening, etc.
I think the true value of the book comes from the authors' attempts to explain a way of looking at information in the research literature. They warn about the dangers of using "subjective endpoints" like pain which are heavily dependent on the placebo effect, or "surrogate outcomes" like blood-pressure and blood glucose which are not always linked to what you actually want to measure ("does this treatment lead to less death/disease?").
One of my favorite parts of the book was the section on screening for cancer. The authors explain this much more eloquently, but apparently since we started recommended wide-spread mammography screening, we've caught more cases of early breast cancer, but the rate of advanced breast cancer stayed the same! Meaning, that the vast majority of people who were treated for early breast-cancer never needed the treatment in the first place (i.e. would have been cured on their own). When chemotherapy can be a poison in and of itself, we really have to ask whether or not the screening is doing more harm than good.
The authors go through the different types of clinical studies as well. They explain cohort (observational) studies, which are comparable to retrospective case-control studies, and the reason why both are inferior to randomized controlled trials (the "gold standard" of clinical trials).
In their research, the authors found that ~40% of standards of care, widely accepted practices in medicine, ended up becoming reversals. The second half of the book is mainly concerned with figuring out what may have lead to our current predicament, and potential solutions. There are strong financial conflicts of interests all across the board: drug makers funding research, device makers funding specialty society gatherings, specialists making money off of procedures (e.g. stents, vertebroplasty), etc. The FDA fast-track system has been abused, lowering the bar significantly for what counts as evidence in getting drugs approved. Some problems are more fundamental, such as the way medical students are taught.
This is a very significant book that makes good reading if you are a healthcare worker or are interested in medicine. It could teach you, as it did for me, the importance of evidence based care, and how we could take one step further in bettering the field. Dr. Prasad has done interviews with Freakanomics before, I recommend you check it out if you are hesitant about jumping into the book.
The problem arises because no matter how well we might understand a particular mechanism of a drug or implant, no matter how much an intervention might make sense, the reality is that "the human body is so complicated, and our understanding of it so superficial, that what we believe should work often does not." (p.166).
The first part of the book is a survey of modern reversals in the past several decades (treatments that are adopted without evidence and later withdrawn). The list here includes coronary stents, vertebroplasty, estrogen replacement therapy, breast and prostate cancer screening, etc.
I think the true value of the book comes from the authors' attempts to explain a way of looking at information in the research literature. They warn about the dangers of using "subjective endpoints" like pain which are heavily dependent on the placebo effect, or "surrogate outcomes" like blood-pressure and blood glucose which are not always linked to what you actually want to measure ("does this treatment lead to less death/disease?").
One of my favorite parts of the book was the section on screening for cancer. The authors explain this much more eloquently, but apparently since we started recommended wide-spread mammography screening, we've caught more cases of early breast cancer, but the rate of advanced breast cancer stayed the same! Meaning, that the vast majority of people who were treated for early breast-cancer never needed the treatment in the first place (i.e. would have been cured on their own). When chemotherapy can be a poison in and of itself, we really have to ask whether or not the screening is doing more harm than good.
The authors go through the different types of clinical studies as well. They explain cohort (observational) studies, which are comparable to retrospective case-control studies, and the reason why both are inferior to randomized controlled trials (the "gold standard" of clinical trials).
In their research, the authors found that ~40% of standards of care, widely accepted practices in medicine, ended up becoming reversals. The second half of the book is mainly concerned with figuring out what may have lead to our current predicament, and potential solutions. There are strong financial conflicts of interests all across the board: drug makers funding research, device makers funding specialty society gatherings, specialists making money off of procedures (e.g. stents, vertebroplasty), etc. The FDA fast-track system has been abused, lowering the bar significantly for what counts as evidence in getting drugs approved. Some problems are more fundamental, such as the way medical students are taught.
This is a very significant book that makes good reading if you are a healthcare worker or are interested in medicine. It could teach you, as it did for me, the importance of evidence based care, and how we could take one step further in bettering the field. Dr. Prasad has done interviews with Freakanomics before, I recommend you check it out if you are hesitant about jumping into the book.
June 20, 2019
Great overview of the topic. Medical Reversal is apparently the term for when a standard practice in medicine gets stopped due to data showing it is either worthless or actively harmful. Novelty in medicine gets more attention and love than verifying, and we as humans are really good with coming up with reasons why something might work. I was surprised to see a chapter on alternative medicine here, but it was well-placed. The same combination of crappy to non-existent date plus wishful thinking drives both the adoption of novel medical treatments and snake oil like acupuncture and homeopathy. We all do it. The FDA is in a no-win situation (even before this current administration gutting every regulatory agency): take the time to really test to see if a drug works better than what’s already out there and prove that it won’t cause harm and people complain that approval takes too long. Approve a drug quickly based on surrogate endpoints and you approve a treatment that ends up needing to be taken off the market because of its harms.
The authors are optimistic that things can be changed, and lay out a rational proposal for doing so, including changing med school education and focus. I’m not sure I share that optimism.
There is even a chapter at the end on how, as a patient, to navigate your own health care. There are great suggestions of questions you can ask your doctor to help you clarify the best way forward with your treatment.
This books is a must-read for everybody.
The authors are optimistic that things can be changed, and lay out a rational proposal for doing so, including changing med school education and focus. I’m not sure I share that optimism.
There is even a chapter at the end on how, as a patient, to navigate your own health care. There are great suggestions of questions you can ask your doctor to help you clarify the best way forward with your treatment.
This books is a must-read for everybody.
July 21, 2019
What a phenomenal and timely book! The text explores the many contributors to 'medical reversals' - that is, thus finding out that a treatment we have been using for years is actually not beneficial at all and in some cases may be harmful. And the magnitude of harm is staggering in terms of health, lives, and financial cost. It concludes by considering possible ways to begin addressing the issue, including advice for patients, possible changes to medical education, and the structure of healthcare systems and research.
Well written and highly accessible to both those in the medical field as a profession and those who encounter it as a patient. For those in medicine and medical education, I think this book is a must-read. It is a fantastic overview that should influence how we think about standard treatments and how flimsy the evidence-base behind these treatments often is. It also provides the necessary information, framework, and vocabulary that can be useful in discussions with patients. Excerpts could also be used as part of an evidence-based medicine curriculum or journal club discussion . It also offers an important perspective as people consider what an improved healthcare system should look like.
Well written and highly accessible to both those in the medical field as a profession and those who encounter it as a patient. For those in medicine and medical education, I think this book is a must-read. It is a fantastic overview that should influence how we think about standard treatments and how flimsy the evidence-base behind these treatments often is. It also provides the necessary information, framework, and vocabulary that can be useful in discussions with patients. Excerpts could also be used as part of an evidence-based medicine curriculum or journal club discussion . It also offers an important perspective as people consider what an improved healthcare system should look like.
September 3, 2019
I really enjoyed this book and it got better with every chapter. We often implement medical practices and educational practices without fully understanding where they came from and whether they are truly of value. I love that this book gives us a bit of history; ie: that the first two years of medical school were designed before World War I, that gabapentin was initially intended to be an anti-seizure medication, that even after a medical reversal of some major study or practice it seems to take awhile for doctors to acknowledge it and change their practice.
For me, it makes me more eager to seek out the non industry funded randomized controlled trials to substantiate the decisions I make in my own practice.
The fact that physiology and pathophysiology can’t fully explain or consistently correlate with the outcomes of well designed trials is something I will sit with. I can see this book being of great educational value for doctors and trainees alike.
For me, it makes me more eager to seek out the non industry funded randomized controlled trials to substantiate the decisions I make in my own practice.
The fact that physiology and pathophysiology can’t fully explain or consistently correlate with the outcomes of well designed trials is something I will sit with. I can see this book being of great educational value for doctors and trainees alike.
October 8, 2018
This was an excellent book on the problems with accepting medical trial data at face value. I think every clinician should read it to improve their understanding of drug literature and their ability to evaluate it critically. I loved this book, and not because I know the Dr. Prasad personally, but because I think this is a needed conversation in medicine. I will say that it definitely gave me some anxiety. Whatever corruption I had recognized in medicine myself prior to reading this book was magnified 11-fold after reading it, and it even kept me up a few nights. Probably not something to read right before bed if you are prone to anxiety like I am, haha. Also if you read this book and like it, I highly recommend the podcast by Dr. Prasad as well called “Plenary Session.”
December 1, 2018
Thoroughly enjoyable. This is the predecessor to the author’s recently released podcast “Plenary Session,” which I also highly recommend. This book is an excellent primer on the importance of evidence-based medicine, a critique of how our best intentions sometimes can lead us astray, and a call to action for changes to streamline the trial process and provide more evidence that the care we give our patients results in better outcomes.
March 3, 2020
Great book. I do believe you have to be a healthcare worker or in the research field to understand in depth this book. This books is a slap in the face and a eye opener for doctors and for evidenced based medicine. My current and future practice will be molded by this book. I will recommended it to a lot of peers and can only hope that some of the ideas exposed here are immplemented in the future for a better healthcare system. Extremely geatfull to the authors.
March 28, 2020
The best book on medicine I've ever read. Absolutely essential for any physician to read. But also essential for any current or future patient to read. Read this during the middle of the covid19 pandemic, and it really is a good corrective when seeing the amount of panic based medicine that is currently being performed.
April 17, 2023
I read this for the second time after 5 years. Still very original and valid. Highly recommended to every patient, provides insight into the medical establishment, how doctors think and how they make their decisions. Also provides insight on what to ask and how to to interact with your doctor for the best possible outcome that could come out of that interaction.
February 24, 2021
This book has actually changed my thinking around medical research quite a bit. My end state is somewhat inconclusive, which is a good thing I think. The book has made me spend time thinking about how we should approach research on a system level, in a balanced way. The authors end the book by suggesting a new structure for medical education, and this seems very reasonable - I will have to review the details a number of times and discuss with professionals before I end up with any kind of finished idea. Which is a very good grade, indeed.
July 26, 2024
Medical reversal: when doctors start using a medication, procedure or test without a robust evidence base; and then stop using it when it is found not to help, or even to cause harm.
I highly recommend this book, especially for my friends in any healthcare field.
I highly recommend this book, especially for my friends in any healthcare field.
October 20, 2025
Anyone going into the medical profession should read this book. A little harsh on the pharmaceutical industry, which while partly justified, has contributed significantly to getting beneficial treatments to clinical practice
June 17, 2019
Brilliant.
May 25, 2020
Controversial??
October 19, 2020
Mandatory reading for anyone interested in learning why we choose to take some actions over other actions when we are trying to improve our own or other people's health.
December 21, 2020
This should be required reading for aspiring physicians.
April 19, 2021
Eye-opening glimpse into and suggested solutions to a pervasive problem of modern medicine.
February 13, 2023
last few chapters dragged a bit, although you can't argue with their argument.
April 25, 2025
Phenomenal book. Extremely intelligent authors, well thought out arguments.
September 30, 2024
This may be a niche topic, but it’s one I care about. Medicine can be wrong about treatments we think work, and the only way to tell is to study them (ideally with a randomized, controlled trial). Most sobering is that some of these treatments make patients worse off, not better. This book chronicles the many times we’ve had to reverse a practice that was found ineffective. I think clinicians should be aware of this concept so we have more humility about the things we do today that will later be changed.
Why do these mistakes happen? I blame our compulsion for mechanistic explanations. Daniel Kahneman discusses at length in Thinking Fast, Thinking Slow how our brains naturally create causal explanations, which are often oversimplified, incomplete, or just wrong. If we know people with irregular heart beats have a higher chance of dying, and we have a medication that reduces those irregular heart beats, then that medication must save lives, right? Sadly, the medication actually led to more deaths, but we only learned that after running a trial. The human body is a complex system, so our explanations for how treatments work are probably incorrect. This is true for other complex systems relevant to public policy (for fun, look up the plastic bag ban in New Jersey that resulted in more plastic going to waste). The term ‘unintended consequences’ exists for a reason.
Here’s where the authors don’t give physicians enough credit: patients come to their doctors expecting them to do something. If we aren’t sure if a treatment is effective, patients are often happy to try something that might help in the midst of uncertainty. It is very uncomfortable to offer a patient nothing in response to their symptoms or illness. I would even say prescribing a treatment is integral to creating the therapeutic relationship of healing, something open-label placebo studies are demonstrating (i.e. some diseases get better even when patients are told they are receiving a placebo). It is wrong to mislead patients, offer an inappropriate treatment (e.g. antibiotics for a viral infection), or knowingly cause harm. But the authors could have been more gracious to the patient and doctor who mutually agree that doing something provides more hope than doing nothing.
Stay tuned for me to finish the book on why the hype around RCTs is overblown.
1. Echt DS, Liebson PR, Mitchell LB, Peters RW, Obias-Manno D, Barker AH, Arensberg D, Baker A, Friedman L, Greene HL, et al. Mortality and morbidity in patients receiving encainide, flecainide, or placebo. The Cardiac Arrhythmia Suppression Trial. N Engl J Med. 1991 Mar 21;324(12):781-8. doi: 10.1056/NEJM199103213241201. PMID: 1900101. https://www.nejm.org/doi/10.1056/NEJM...
2. New Jersey Plastic Bag Ban Goes Bust. https://www.wsj.com/articles/new-jers...
3. Kaptchuk TJ, Miller FG. Placebo Effects in Medicine. N Engl J Med. 2015 Jul 2;373(1):8-9. doi: 10.1056/NEJMp1504023. PMID: 26132938. https://www.nejm.org/doi/10.1056/NEJM...
Why do these mistakes happen? I blame our compulsion for mechanistic explanations. Daniel Kahneman discusses at length in Thinking Fast, Thinking Slow how our brains naturally create causal explanations, which are often oversimplified, incomplete, or just wrong. If we know people with irregular heart beats have a higher chance of dying, and we have a medication that reduces those irregular heart beats, then that medication must save lives, right? Sadly, the medication actually led to more deaths, but we only learned that after running a trial. The human body is a complex system, so our explanations for how treatments work are probably incorrect. This is true for other complex systems relevant to public policy (for fun, look up the plastic bag ban in New Jersey that resulted in more plastic going to waste). The term ‘unintended consequences’ exists for a reason.
Here’s where the authors don’t give physicians enough credit: patients come to their doctors expecting them to do something. If we aren’t sure if a treatment is effective, patients are often happy to try something that might help in the midst of uncertainty. It is very uncomfortable to offer a patient nothing in response to their symptoms or illness. I would even say prescribing a treatment is integral to creating the therapeutic relationship of healing, something open-label placebo studies are demonstrating (i.e. some diseases get better even when patients are told they are receiving a placebo). It is wrong to mislead patients, offer an inappropriate treatment (e.g. antibiotics for a viral infection), or knowingly cause harm. But the authors could have been more gracious to the patient and doctor who mutually agree that doing something provides more hope than doing nothing.
Stay tuned for me to finish the book on why the hype around RCTs is overblown.
1. Echt DS, Liebson PR, Mitchell LB, Peters RW, Obias-Manno D, Barker AH, Arensberg D, Baker A, Friedman L, Greene HL, et al. Mortality and morbidity in patients receiving encainide, flecainide, or placebo. The Cardiac Arrhythmia Suppression Trial. N Engl J Med. 1991 Mar 21;324(12):781-8. doi: 10.1056/NEJM199103213241201. PMID: 1900101. https://www.nejm.org/doi/10.1056/NEJM...
2. New Jersey Plastic Bag Ban Goes Bust. https://www.wsj.com/articles/new-jers...
3. Kaptchuk TJ, Miller FG. Placebo Effects in Medicine. N Engl J Med. 2015 Jul 2;373(1):8-9. doi: 10.1056/NEJMp1504023. PMID: 26132938. https://www.nejm.org/doi/10.1056/NEJM...
February 17, 2021
If you are even remotely involved in health-care, this book will and must intrigue you. The book explores in detail the world of medical reversal and how 'feeling better' can be often misleading. The science behind how medical procedures elicit a placebo effect is wonderfully illustrated. Reversals in screenings tests are the worst since it involves procedures on healthy people. The book also highlights the problem associated with over-diagnosis especially in cancer. You don't have to be a genius to understand that if 'screening' finds many unimportant cancers, it's just exposing patients to treatments unnecessarily.
Solutions are obviously rooted in how we conduct our trials. Endpoints of medical trials are often flawed. What we need is a continued pullback on recommended screening tests. A test must always needs to show that it saves 'actual' lives before it is instituted. When things go awry, it is usually not that a single individual fell short but that the system was designed poorly and an error either was not caught or was actually magnified by other people's actions. We err when we implement practices based on a good theory, on the experience of only a few hospitals, or on studies that are not well done.
"Door-to-balloon time", "reperfusion", are all examples where a lot of time, money and energy was spent as a part of systems intervention only to be overturned later on. The major problem in medicine is to take what we know and ensure it gets done right. This book also serves as a definitive guide to finding flawed medical therapies on our own. Laypeople, just like doctors are prone to adopt therapies that are not well founded. Sources of medical reversals are plenty. Industry-sponsored trials where results are promulgated and design is subtly skewed to favor one outcome. When companies hold back evidence, the medical literature becomes just the tip of the trial iceberg - a handful of trials selectively drawn from a much larger pool. This book is a must must read.
Solutions are obviously rooted in how we conduct our trials. Endpoints of medical trials are often flawed. What we need is a continued pullback on recommended screening tests. A test must always needs to show that it saves 'actual' lives before it is instituted. When things go awry, it is usually not that a single individual fell short but that the system was designed poorly and an error either was not caught or was actually magnified by other people's actions. We err when we implement practices based on a good theory, on the experience of only a few hospitals, or on studies that are not well done.
"Door-to-balloon time", "reperfusion", are all examples where a lot of time, money and energy was spent as a part of systems intervention only to be overturned later on. The major problem in medicine is to take what we know and ensure it gets done right. This book also serves as a definitive guide to finding flawed medical therapies on our own. Laypeople, just like doctors are prone to adopt therapies that are not well founded. Sources of medical reversals are plenty. Industry-sponsored trials where results are promulgated and design is subtly skewed to favor one outcome. When companies hold back evidence, the medical literature becomes just the tip of the trial iceberg - a handful of trials selectively drawn from a much larger pool. This book is a must must read.
February 2, 2024
Wonderful book that gives an insight into not just medicine and medical research but into critical thinking and how one should evaluate evidence.
Long review coming soon.
Long review coming soon.
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