This may be the most important post I have ever published. Iâ€™m going to tell you about a study that should change the entire way doctors approach patients, and how patients should think of prescribed treatments. These findings should begin a culture change in American medicine.
I used to think Medicine would get easier over time. It makes sense, right? You see patterns, you learn how treatments work, and you just get to know stuff. Experience should make it easier to diagnose and treat.
Thatâ€™s not been the case for me. In fact, itâ€™s closer to the opposite. In the exam room, as I look up to the patient from my stool, and before I stand at the white board to explain, I often find myself pausing for a moment to think: Is this really the right course? Does the evidence support doing it this way? Do I know the science, or is it “just the way things are done?” I have the same problem in the hospitalâ€”perhaps worse, as there, dogma permeates most of what we do.
What keeps popping into my head is the hubris of Medicine. As I grow older, the excessive pride and confidence of the medical establishment becomes more obvious. Why didnâ€™t I see it before?
In many cases, medical and surgical treatments that were once thought to be beneficial turn out to be not so. Often, these therapies were backed by expert guidelines and taught to young students as law. Think of that for a moment. We do things to people; we monitor, we medicate, and we even cut, all with the aim of helping. But then further study proves that we were actually providing no benefit and in some cases, causing harm.
This is sobering.
The most important study in decades:
A recent article, published in the journal Mayo Clinic Proceedings, provides chilling evidence that many well-established medical practices are wrong. Researchers from the National Institutes of Health looked at 10 years of clinical investigations from the New England Journal of Medicine. Over the past decade (2000-2010), they found 363 published studies that evaluated an established therapy.
In 146 of the 363 studies (40%), the scientific evidence caused a reversal of established medical practice. Thatâ€™s a sterile way of saying that nearly half the time the prevailing wisdom was wrong. It is worth going over some examples. Not one branch of Medicine was spared a reversal.
In my field, electrophysiology, the AFFIRM trial revealed that the strategy of using rhythm control drugs to maintain sinus rhythm in elderly asymptomatic patients with AF did not reduce stroke, hospitalization and death rates. To this day, nearly ten years out, I still see AF patients on rhythm drugs because a doctor thinks this strategy will prevent stroke or reduce the risk of death.
In interventional cardiology, the idea that coronary blockages need to be ‘fixed’ is ingrained. Fueled by favorable reimbursement, intense marketing from industry and an insatiable public demand for being â€˜fixed,â€™ stent implantation has soared. Then the COURAGE trial showed that implanting stents in patients with asymptomatic coronary disease was no better than optimal medical therapy and lifestyle modifications. Again, to this day, wide variations in cardiovascular care suggest too many doctors ignore scientific evidence.
Preventative cardiologists also took their share of lumps. Hormone replacement therapy for women was perhaps the most famous reversal. Millions of women were treated with hormones under the guise that manipulating female hormones would be â€œcardio-protective.â€ But HRT was based only on observational studies. Randomized clinical trials proved the concept wrong.
In Pediatrics, therapy of inner ear infections set the stage for a huge medical reversal. Doctors were fearful that recurrent otitis media would cause long-term hearing loss. Guidelines recommended early intervention with surgery (tubes) to prevent complications. But then two major trials showed no benefit. One of the most commonly done procedures in all of Pediatricsâ€”wrong!
In ICU medicine, the pulmonary artery catheter (Swan-Ganz) was thought to provide invaluable data on a patientâ€™s heart and lung function. You just couldnâ€™t manage a sick patient without one. Surgeons, too, thought the balloon-tipped catheter was necessary for major operations. Then, when it was studied systematically, no benefit was found. A generation of doctors toiled over those pressure tracingsâ€”all for naught.
Cardiac surgeons do not like bleeding after they close a chest. An almost magical (procoagulant) drug called aprotinin was found to decrease post-op bleeding. Not until after the use of aprotinin became established practice did four studies refute its benefit. Here the story gets worse. Aprotinin increased mortality.
In Anesthesia, one of the more feared complications is patient awareness of surgery. Itâ€™s a terrible outcome, which, in some cases leads to PTSD. It was no surprise then that Anesthesiologists jumped at the chance to use a nifty little monitor stuck on a patientâ€™s scalp. The bi-spectral index monitor quantifies the deepness of a patientâ€™s sedation during surgery. Despite only one industry-sponsored study, use of the monitor surged, and it nearly became a standard of care. Then in 2008, a large randomized trial showed no benefit.
Medical reversals in Oncology were especially sad. Thousands of women with advanced breast cancer were exposed to unnecessarily aggressive surgery or chemotherapy (with stem-cell transplantation) before careful clinical trials showed no benefit. Gosh did some women suffer needlessly. Metastatic breast cancer is bad enough; heaping this therapy on at the end of life was tragic.
In diabetes care, we learned the hard way that strict control of blood glucose in hospitalized patients worsened outcomes. I remember the medical staff meetings where protocols designed to micro-manage blood sugars were presented. The experts were sure. Blood sugar had to be strictly controlled. Wrong again. Too much action caused harm.
I could go on. There are many more examples. A total of 146 similar narratives are available here in this PDF file. Reversals included medicines, procedures, diagnostic tests, screening and medical devices. If an intervention was not based on solid scientific evidence, there was a nearly 50% chance it was wrong. What’s more, some of the most striking reversals came when therapy was aggressive.
The authors emphasize three reasons why medical reversals are so serious. First, millions of humans were harmed. The second issue is continuing harm. Some estimates suggest it takes ten yearsâ€”on averageâ€”to change entrenched medical practice. Believe me, ten years may be an underestimate. Third, medical reversals cause harm because they erode trust in the patient-doctor relationship. Patients expect doctors to be either correct, or transparent about uncertainty. You have seen how the erosion of trust can lead to patients refusing beneficial therapy. (Think vaccines.)
Four important messages stand out:
— Doctors must strive to be better judges of science. When we intervene, especially in an aggressive way, with procedures, or surgery, or potent chemicals, we must be sure the science backs us up. Our interventions should never be eminence-based, but rather, evidenced based.
— Hubris has to go. Though there is a role for â€˜assess and decideâ€™ in the practice of medicine, we must become more honest and skeptical with ourselves. Letâ€™s get comfortable with uncertainty. This way, we can better communicate with our patients. When a prescribed therapy merely makes sense (or is just a good idea), all involved parties should proceed with caution.
— This data should reset the default of American Medicine. Currently, most everyone expects action, intervention and monitoring. Do something doctor! This needs to change–immediately. Our default should be to intervene and monitor only when the evidence supports doing so. These findings call us to share decisions with patients and default to a culture where less is more.
–This is not just important information for doctors. Patients seeking medical treatment should not assume a prescribed therapy is beneficial just because a doctor says it is. The era of paternalism in Medicine is over. Patients should be able to ask their doctor whether the evidence supports the intervention. Itâ€™s okay if the doctor is uncertain. In fact, doctors who are too sure of things worry me.
Make no mistake; the fury of modern medicine is a beautiful thing. Itâ€™s a great time to be a patient and a doctor. Whenever it comes time to act, however, it seems healthy to consider what the next generation of caregivers will think of our plan. Iâ€™m sure prescribing good food, good exercise, good sleep and good attitudes will stand the test of time. Iâ€™m not so sure about a lot else. If ear tubes and tight control of diabetes donâ€™t stand up, what will?
28 replies on “Changing the culture of American Medicine — Start by removing hubris”
Dr M – this post is profoundly important. As a heart patient, it’s also deeply troubling to me (which, as you would say, is not good for my inflammatory process) on so many levels.
Troubling because we need to trust our docs. We need to believe that the stent/ICD/aggressive chemo/HRT/ear tubes/drugs being recommended by very smart people with the letters M.D. after their names are indeed what will help us – and not harm us.
Troubling because the outcome of defensive medicine and ‘ask your doctor’ DTC ads and whizbang technology covered in the media is that patients demand – and often get – tests and procedures that, as suggested in this Mayo report, are ultimately found unnecessary or even deadly – yes, even despite the best educational efforts and objections of their physicians.
Troubling because it seems we have things all mixed up somehow: doctors are being told that if they disclose their financial conflicts of interests with those who make the devices and drugs they are promoting, it’s the same as not being on the take from industry in the first place. Dr. Ivan Oransky updates us almost daily (via Retraction Watch) of yet another esteemed journal retracting yet another scientific paper for fraud. An alarming number of practicing physicians admit that they would not choose medicine if they had it to do over again.
One wonders: how did we get here? Thanks so much for this attempt at kicking off the culture change.
I am glad you posted. Thanks. But isn’t it true that things won’t change until they get ‘troubling?” I am hopeful that we are moving in the right direction. The Patient Centered Outcomes Institute and the work of folks like Dan Matlock (University of Colorado) should give one optimism. You are right though, it’s going to be have to come from both doctors and patients. Some of the dumb stuff that gets continued in Medicine occurs because of patient expectations. Patients aren’t used to being told to fix their blood pressure or high blood sugar with lifestyle choices, they are used to getting the ‘fix’– ie stents.
As for conflict of interests, I struggle with that. Clearly, innovation requires partnership with industry. But these are humans, so running amok is always a possibility.
Your final point is the most chilling. An alarming number of doctors are choosing to jump off the treadmill, not get on it or turn down its pace. These choices are less about dollars and more about the resection of joy from the practice of medicine. Most surgical procedures have consequences, resection of joy from care-giving will too. That won’t be a problem if you are well, or rich enough to jet up to Minnesota, but it could be a problem for many people. Think of AF ablation: there are only a handful of doctors in this city who really know how to do it. One is retiring and one is thinking of lots of other things. Then what? Will the others doing it get better at it? Will skilled young doctors move in, accept a brutal call schedule and lower pay? We shall see. It’s worse with primary care.
John Your last paragraph in answer to C is chilling because it rings true. The obvious answer for those able to do so is to stay well by healthy lifestyle and do your best to steer clear of interventions. But many (most) individuals are unable to do this indefinitely – which is where the chilling part beings …
In grad school, I had class with a top tier endocrinologist who started every semester with this: ” Half of what I’m going to teach you this semester is wrong. I just don’t know which half.” Despite being an expert is his field, he had the humility that comes from experience.
More often than not, science reporting in the popular media gives me the same type of pause. Anyone who uses the phrase ‘settled science’ doesn’t understand science.
It’s ironic, as we leap head first into the era where a panel of experts decides the standard of care for all of us.
This “McMedicine” will provide benefits as correct practices will spread far and wide. I shudder to think of the harm as incorrect practices will spread just as far.
If only we could figure out which half…..
Great insight Joe. Thanks for the kind words. Both you and Wes echo the looming harm if we don’t jettison the hubris. For if we are so sure of ourselves, and then make certain treatments ‘quality’ measures, harm might actually be increased. And yes, that panel scares me.
This post should make everyone pause and think about the sanity of irrefutable checklists and the appropriateness of ‘Cheesecake Factory’ medicine – especially when original ‘production line’ gets it wrong.
Imagine: medicine as an art. Who knew?
Yes Wes. Thank you. Our hubris will only be amplified when we codify errors into checklists and guidelines. Look no further than multaq. I think your comment may be at the heart of why standard guidelines on cholesterol and blood pressure mangement have not yet been updated. Imagine the consternation if/when they figure out that the entire concept of titration of drugs to achieve certain bio-markers (ie LDL/HDL) makes no difference.
Excellent post about a humbling article that ought to be required reading for medical students and residents. I believe many of us who have practiced for a period of years have become wiser about this issue through the powerful “learning process” of seeing what used to be “doctrine” in so many areas fall out of favor. Awareness of the limits of our knowledge is essential for optimal doctoring.
Thanks Ken. I think it’s both knowing the limits and being realistic about the limits. Then, once we are comfortable with the limits of medicine, less is more looks more attractive.
you write: ‘Doctors must strive to be better judges of science. When we intervene, especially in an aggressive way, with procedures, or surgery, or potent chemicals, we must be sure the science backs us up.’
On the other hand: added to this should be the increasing uncertainty about what to believe at all of the existing literature, in spite of stricter disclosure policies and reporting conflict of interest by authors. Uneasy feelings about the trustworthiness of many articles increasing.
It’s a good thing to strive for a more scientific attitude, sure, but it will work better when honesty in science gets a chance to come back on stage ad rule it.
Great article. Note: all for naught (not “not”). Emphasize not empathize.
Got it. Thanks. Changes made.
I don’t think anyone can trust a doctor who gets a benefits from one drug being prescribed over another drug, or when he stands to benefit from a medical device thats going to be used in a procedure. A doctor hands must be clean. If you are on the take from a pharma or med device company and are prescribing a medication or recommending using a medical device, you need to tell the patient about your conflict of interest.
As almost everyone else has said, great post John,
I really like your emphasis on the fact that upon reflection and careful study, we learn that some things don’t work, and we should change. I’m not sure that this doesn’t mean that we shouldn’t do the best with what we have and try to practice to the best evidence that we have – Krumholz calls much of what we do “semi-evidence based medicine”. Still, that may be the best that we can do for a while, until we use Clinical Judgment (Feinstein’s term) to change our check lists, or say why we aren’t following the crowd. Blindly following may be as bad as blindly going off on our own. Didn’t we go to med school to learn how to separate the wheat from the chaff – AND learn over time what half of what we learned WAS wrong?
Thanks for sharing your point of view. Wish I had done it sooner.
An absolutely beautiful article!
I’ve recently been introduced to a concept call “minimally disruptive medicine” (May C et al. We need minimally disruptive medicine. BMJ. 2009 Aug 11;339:b2803) where the burden of benefit should be balanced with the burden of treatment. As we get to a place in medicine where we talk about smaller absolute benefits and larger absolute costs, these trade-offs become more difficult and they are more easily disproven.
Your experience of sitting in clinic and asking is this really the right thing really resonates with me. I try hard to be more patient centered and I was 40 mintues behind with no notes finished at the end of my clinic this morning.
This is tough and it will require culture change but I’m not sure we really even have a choice…
Really awesome article.
Great article! When my husband was suffering from atrial flutter, the best of the electrophysiologists who had previously collaborated in doing him permanent harm made repeated aggressive efforts to push him onto amiodarone for rhythm control (stymied by my equally aggressive pushback) or get him to submit to a mega-ablation for the atrial fibrillation he would surely have someday. Had that guy not read the AFFIRM study, or did it just violate a tenet of his faith? He refused even to deal with adjusting prescriptions to achieve adequate rate control – he would not be involved in such heresy. (He had previously asserted, among other things, that strict rate control was the only acceptable standard and never mind what the studies say.) When fifteen or twenty such points of ignorance or arrogance might be enumerated, is it any wonder that my husband has decided to live with and die by what nature dishes out to him rather than what the medical industry would like to dish out? In my family’s experience, specialist doctors as humble and wise as you are few and far between. It is beyond enraging to see a loved one suffer severe and unnecessary harm, not just from one incompetent quack, but from two teams of highly reputed specialists all looking down their noses and telling you that they know everything and you know nothing – especially when then you find out that much of what they did, omitted doing, or wanted to do had already been proven wrong in published literature.
Jane…. wow! well said! I too have A-fib & my EP forgot I had a leaky mitral valve, refused to refer me to a surgeon, and told me I needed stents, that my arteries were 70% occluded. A second opinion reviewed the procedure & said it was 30% ; no stents needed. Eventually i had OH to repair the mitral valve, but by then the heart failure was so advanced, I barely could function for 18 months.
Is there nothing patients can do with this type of attitude? Especially in a small town with few options available?
What? Inflammatory biomarkers have no utility in cardiovascular risk assessment? You didn’t mention that one, but it’s there in the list of 147. Surely that can’t be right. Could the role of inflammation in cardiovascular disease havebeen overstated?
Is it possible that we’re all doing the best we can do with the information we have? Could we be at the mercy of unscrupulous behavior at the publish or perish herd of independent thinkers at the academic level regarding the continual changing wind direction in New Millenial Medicine?
Might it be reasonable to extend a bit of grace to your colleagues and to the American medical community in general?
A. Bailey’s point about extending some grace to the American medical community is indeed valid. Many in the community have done the best they felt possible given the information available. That said – Dr. John’s 4 Important Messages at the end of his post state the essence of this issue. Dogma in medicine previously ruled. I think it important to appreciate that much of this previous dogma has simply not withstood the test of time. The data in this study should reset the default in American Medicine.
Great article John.
Medicine is a continuous learning experience for everyone involved. As long as we maintain our focus on delivering the highest quality care to our patients with compassion I believe we will do the best we can.
One thing I have learned is that sometimes we are just watching as nature takes its course, and we need to know when to get out of the way.
Excellent article that clearly demonstrates what I have known since the first days in my professional career. What is that I learned and have carried with me? Well, in healthcare there is overwhelming evidence that as a profession we walk a path along side and with the ever changing and raw experiences of life. As result of this intimate and prestigious encounter it is not for us to claim to know the answers, expect to control the outcomes, or choose for others their part along the path of knowing life. No ours is to have an earned honour to accompany them and share with them in their choices and accept their informed outcome. To do more or think we are capable is to lend our combined objective and subjective prejudices to those who come merely seeking assistance not our burdens. So yes we as healthcare providers should share our knowledge and “expert” evidence based knowledge, however ultimately if we are to do no harm, we must allow those who come to us to have their own unprescribed life experiences.
Excellent discussion, and the most important point, in my opinion, is that we all need to get comfortable with uncertainty. Last year I was interviewing neurosurgeons in regard to my rather large and ambiguous brain tumor, having suffered through years of confident dismissal of my symptoms. And I passed on the senior neurosurgeon in my HMO, who presented a “slam-dunk”diagnosis and prognosis in favor of the younger guy who was honest about his own uncertainty and discussed surgery in terms of: “But that will depend on what we find…” At one of our research centers a “famous” NS was also modest and uncertain, and that clinched it. The young NS was wonderful and my outcome couldn’t be better.
Cookie-cutter guidelines terrify me. I’m speaking as a patient who has suffered through many a confident misdiagnosis from docs who rejected my suggestions with: “But that would be rare” or “That is not the protocol.” Years later, it turned out that I was on the right track, and it’s worthwhile to remember that anyone with an unusual condition has it 100%.
I think one of the points I would emphasize is the real challenge of applying population-based studies to individuals. I think about some of the blockbuster medications that came out when I was in training, and how I wrinkled by brow when they had NNT of 30-50. I expect that even in those negative trials, there are individuals who do probably benefit, but it is impossible to know who. So we throw a given treatment at everybody who meets the inclusion criteria and hope it sticks.
I think just about every conversation I have with a patient is some iteration of: “Over the next 10 years, you have a 10% chance of having something bad happen, and a 90% chance you won’t. I can give you this medication that will reduce your risk to 7%. Now we know practically nothing about whether you are in the 3% of people who would actually benefit from this medication. But hopefully you can afford it and you won’t get side effects. Ready to gamble?”
Of course, this conversation makes the assumption that the data I am quoting are correct, which goes back to the original point. Every year I practice I gain more respect for Hippocrates.
Agree with most up til the evidenced based medicine part.
Evidence can be skewed by those who may profit.
Medicine is an art and a science.
Treat individuals, not the populations that EBM is forcing upon us.
Lok closely at NNT’s and decide, would I use this med or have this procedure myself?
The culture of medical care is devolving due to population based statistics and outside $$$ and politics interfering with the health professionals normal sound judgement.
[…] Cardiologist John Mandrola on how we doctors need to get over ourselves. […]
As a layperson I am so impressed with this discussion and that some MDs are leading the way to a less invasive, one size fits all culture in a profession that has clearly swung too far in a bad direction.
Actually, I don’t view this study as evidence of hubris at all. I view it as evidence that medicine actually does change with the evidence and science. The process is messy and sometimes (well, often) a lot slower than idea, but medicine does change:
Everyone reading this should consider supporting the AllTrials effort http://www.alltrials.net/ , which calls for registration and release of raw results from all clinical trials. (Ben Goldacre, author of Bad Pharma, is one of the sponsors.)
Too often, data from clinical trials is massaged for a desired result. Negative results are buried. Pharmaceutical companies very reluctantly release raw data for independent statistical analysis. Regulatory agencies are inadequate to the task of keeping the studies honest.
This has thoroughly corrupted the field of psychiatry. The clinical use of psychiatric drugs is predicated on an evidence base that is riddled with disgraced and contested studies.
As argued in David Healy’s Pharmageddon, profit interests are corrupting other fields of medicine as well — as Dr. John’s list indicates above.
This has caused untold injury to millions of patients.
Doctors and patients alike should strongly support the release of all information — please sign the All Trials petition.