Very Bad Numbers

flying cadeuciiThe date is July 17th, 2014. It is 10am in the Dirksen Senate building, and the congressional subcommittee on health and aging is about to focus on patient harm. The educating will be done by some of the leaders in the medical field, Ashish Jha and Tejal Gandhi from Harvard, Peter Pronovost from Johns Hopkins. The star of the proceedings is John James, a toxicologist, a PhD from Texas, and the founder of Patient Safety America.

The tone is set from the beginning by none other than Bernie Sanders. In somber tones, he relays that hospitals can make patients worse, and that a recent study suggests medical errors is America’s third leading cause of death behind only heart disease and cancer. Hospitals are killing patients, and something needs to be done about it. The panelists then go on to speak strongly about the ongoing epidemic of patients dying in hospitals, and re-enforce the staggering numbers introduced by Bernie Sanders.

Headlining the proceedings is an unassuming gentleman named John James. He has a Ph. D in pathology, and he worked as a Chief Toxicologist at NASA. He is at the congressional proceedings, and is one of the lead activists in patient safety because of personal tragedy. His 19 year old son died in the summer of 2002 due to “uninformed, careless, and unethical” care by cardiologists. He proceeded to write a book, “A Sea of Broken Hearts” that details the errors he believes cardiologists made in his son’s care that lead to his death. Of note 2 cardiologists that were sought by Dr. James’ lawyers believe the care his son got did not violate the standards of care. A further 2 appeals to the Texas Medical Board also rendered two opinions from two other separate cardiologists that the standards of care in this case were not only met, but exceeded. Dr. James, armed with information he has carefully selected from a number of different sources, strongly disagrees.

Dr. James is now a crusader for patient rights. He writes of a broken health care system on his website, and more importantly wrote a paper in 2013 in the Journal of Patient Safety that estimated 400,000 patient deaths per year that were due to medical error. No physicians on the panel or elsewhere seem to have any issue with this number, and this has become fairly widely accepted. Even Captain ‘Sully’ Sullenberger, the hero pilot who landed a plane in the Hudson, noted that this was the “equivalent of three jumbo jets going down every day with no survivors.”

As a busy clinician who spends much of his time in the hospital, it doesn’t feel like patients are dying daily because of medical errors. But of course, data necessarily must trump feelings. So, I decided to read John James’s landmark paper.

The paper reviews four original articles that reported on medical error causing patient harm. The first study was a pilot trial of 278 patients that examines one week in August of 2008. The second trial examined 838 patients in October of 2010. The third trial was a very similar study that looked at 795 patients in October of 2004. The most robust (because it was the largest over the longest duration of time) examined 100 hospital admission per quarter in North Carolina. Dr. James’s paper combines all four trials, but weighs the North Carolina trial the heaviest. He simply divides the total lethal adverse events found in all four trials (38) and divides by the total number of records reviewed (4252) to come up with a lethal event rate of 0.89%. He estimates that, of the harms found in these trials, 69% were noted to be preventable. Since there were 34.4 million hospital admissions in 2010, simple multiplication (34,400,000 x 0.69 x .0089) reveals a number of 210,000 preventable harms that resulted in the death of a patient. Dr. James isn’t done here, however. He notes that the tools used to find patient errors are imperfect. He notes that failing to follow guidelines, errors not documented in the medical record, and a failure to make life saving diagnoses would necessarily add to these numbers. He believes that at a minimum, this should increase the actual number of deaths related to medical error by a factor of 2. That’s it. No statistical modeling for how many patients a year present with heart failure and don’t leave on a beta-blocker, no examination of the number of young patients dying due to a missed diagnosis of long QT. He just comes up with a factor of 2 because that feels about right. And there we have it, 400,000 patients, 3 jumbo jets a day crashing, the third leading cause of death in the United States. Dr. James notes this is likely an underestimate. Good thing, otherwise the health care system would be the biggest killer of patients.

I was stunned. This was the evidence? 4 trials. One of the trials took place over one week. All four trials did use the same error reporting tool, but were simply added together, with no regard to the varying settings the different trials took place in. The smallest trial did not even report what percentage of cases were preventable. One of the trials (Classen 2011) was a trial designed to test the efficacy of a patient harm reporting tool, and did not report preventable harm events. Dr. James, inexplicably in his review, notes that 100% of the harms found in this trial were preventable. Another trial, The Office of the Inspector General (OIG) analysis, notes a 44% preventable harm rate, but does not note which deaths were clearly preventable. Far and away, the best quality trial is the North Carolina study from the New England Journal of Medicine. Of the 2341 cases reviewed, there were 588 total harms identified. 364 of these harms (63%) were deemed preventable and 9 of these resulted in patient deaths (0.4%).

Dr. James’ problem is in how he aggregates the data. He includes trials which did not state preventable deaths, and in one case assumes that all the deaths were preventable. If you only used the two trials that published data on preventable harms, the preventable harm rate is 58%, not the 69% listed by Dr. James. Of course, I don’t think one should use this number to estimate the preventable lethal death rate, because this assumes that the total preventable harm rate is equivalent to the lethal preventable harm rate. Why is that a safe assumption? Luckily, since Dr. James’s statistics to arrive at his estimate uses multiplication, and I just happen to be reviewing this subject with my 6 year old, I can generate my own number. The lethal preventable death rate is .384% (9 preventable deaths/2381 total cases reviewed). 34,400,000 x .004 = 130,000 patients. Using the sounds about right Dr. James factor of 2, that brings us to 260,000 patients. That is still a lot of patients, but a lot less than 400,000 patients.

Medical errors are a serious problem, that is no doubt deadly, and needs attention. We in the healthcare community need to work hard locally and nationally to combat this issue. I applaud Dr. James and the other physicians that have shed light on this important issue. Perhaps, the actual numbers don’t matter, perhaps it’s missing the point to focus on the actual number, perhaps it doesn’t matter that Bernie Sanders thinks medical errors are the third most common cause of death. Except, it does.

Bernie Sanders frequently talks about the broken health care system, and in support uses this to buttress his claim. Others (including Dr. James) go further. They specifically point to physicians as the problem. We are the captains of this ship, and we are steering this ship into an iceberg. It generates distrust among the public and foments anger against physicians when patients do not do well. Michael Davidson, a cardiothoracic surgeon at Brigham and Women’s, and more importantly a husband to a pregnant wife and three children, was shot to death by his patient’s son. The assailant’s mother, Marguerite Pasceri, 78 years old, had recently died while she was in Dr. Davidson’s care. She had multiple medical comorbidities and her death was ruled as being related to these severe comorbidities. Unfortunately, fueled by the internet, Steven Pasceri became obsessed with the idea that use of the drug amiodarone had caused her death. He confronted the doctor, the scene is described in chilling fashion by the Boston Globe:

{Right away, Pasceri told Davidson to open the Internet, go to Drugs.com, and look up amiodarone.

“Are you aware that this drug is extremely toxic?” Pasceri asked, St. Jean said, pointing to the website. “Do you see all of the warnings on Drugs.com?”

Davidson explained he was aware of all the side effects but said Marguerite Pasceri did not react badly and was being monitored. Any drug, he explained, even an antibiotic, has potentially dangerous side effects.

“Well, my mother died because of this,” Pasceri said, his face twisting into a snarl.} Minutes later, Dr. Davidson was shot three times.

You would be a fool not to connect the relentless drum beat of the media, congress, and the public about the horrid broken down medical system and the even more horrid, incompetent doctors that are killing patients in hospitals to an event like this.

The facts are that 34 million patients are arriving at hospitals with an illness. They are presenting in distress, in need of help. Dr. James and many leading members of our profession have unfortunately whipped our representatives and the general public into a frenzy. Three jumbo jets are going down every day! The facts are that 0.4%, 4 out of a thousand patients, die from a medical error. Work needs to be done to reduce this rate, but it is unlikely ever to be 0.

The idea that every error in the hospital is a preventable one, the impression that physicians are by and large an incompetent group that is killing patients needs to strongly be repudiated. The reason that it doesn’t ‘feel’ like patients are dying on a daily basis in large numbers due to medical errors is because they are not. Even Dr. James notes that there is no statistically rigorous way to arrive at a number. The number we use today, 400,000, is a made up number. It is based on a feeling. Using this to falsely indict, demoralize, and create a toxic environment for millions of medical providers is in no one’s best interest.

Anish Koka is a cardiologist. He practices in Philadelphia.

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51 replies »

  1. I agree with Dr. Koka that the numbers are inflated. And they are inflated for a reason – they are meant to bludgeon Physicians and the Medical Power Structure into changing.

    Bernie Sanders wants to Socialize/Single Payor Medicine and by pointing out what a bad system we have he gains traction. His implicit promise – Sociailized Medicine/Single Payor will cure the problem.

    There are other people here with other agendas as well.

    So when a 90 yo with CHF, diabetes and multiple other comorbidites dies, and you go back into the chart and find something that could have been done better it must have been the treatment that killed the patient. Because people live forever!

    And anyone who doesn’t agree – well censor them!

  2. I think it’s funny this is a doctor from Philadelphia writing this. I used to live right outside Philadelphia, and I know the arrogance of the doctors there. I know they’d rather send their patient home with a misdiagnosis then seem like they’re searching for answers. I know they’d rather throw meds at you then take time to figure out what could possibly be wrong. I know they’re in such a hurry they do colonoscopies on unseated patients, and I know they’re so extremely arrogant that they can’t admit they made a mistake. Look, I’m not stupid. Mistakes happen in medicine. I think it’s important for everyone, both the patient AND especially the doctor, to realize that no one is perfect and no one is infallible. Unfortunately, I know doctors, especially from the Philadelphia area that think they know it all. The best way to diagnose and treat a patient is to listen to them. Crazy, I know, but it seems to work well for people out here in California. I cannot tell you the difference between patient care out here, and patient care back east. Back east, at just 17 years old, I was butchered by a surgeon who swore he knew it all, and could do no wrong. When I felt something that felt like acid gas start rushing through my stomach, I was a hypochondriac. As I got sicker, I was called lazy, I was told I was a drug seeker. I was 17 years old and had just been inducted into the national honor society. I was looking forward to scholarships to an Ivy League. My priority was not drugs, it was getting better. Well, it took me convulsing and flatlining for him to take me seriously and to do a CT scan. How hard would that have been to do originally? Instead I sat for almost a week while feces leaked into my blood stream, causing me to go septic and get peritonitis and abcesesses. I was so sick, I was told I wouldn’t live through the night unless he went back in. And I cried because I did not want that man touching me again. So sure, doctors make mistakes, it’s life, it happens, but to deny there’s a problem just shows you’re not a very aware doctor. To not even notice the patients dying, what are you a sociopath? Does it mean nothing to you when family loses a loved one?! This whole article is a reason you should be removed from practicing medicine. It’s clear you don’t have your eyes open, and you even admit it. The problem was not that a mistake had been made, the problem was how far he went out of his way to try and hide what happened, and he made me sicker by doing so. He discharged me before I was even tolerating anything by mouth, he privatized me when children in youth sent me back, in disbelief that he let me go to begin with. So many other things happened. He “culled” all records from the first surgery. He blocked every transfer request and had a psychiatrist come in and literally try to brain wash me that it was all in my head. Except it wasn’t. I had to go Mike’s outside Philadelphia, to Lehigh Valley Hospital, up in the mountains, to find a surgeon who actually knew what he was doing. Not only did the first surgeon let feces leak into my blood stream for almost a week, he also left two inches of necrotic bowel in my body, and it was clear to this new surgeon that had a huge part to play in why I wasn’t getting any better. At 17, I was a virgin, and although I didn’t know it at the time, the first surgeon ruined my chances of ever having a child. I am filled with so much scar tissue, I have doctors who call other doctors they work with to see the amount of damage that was done to me. People are in disbelief when they look inside me. At 29, I had my sixth surgery, a hysterectomy. All because scar tissue grew so bad I was in a constant state of dilation, and ovulation. This Philadelphia big shot surgeon ruined my life. I didn’t get those scholarships because I missed my senior year, my mom lost her job sitting by my side everyday for six month straight. She’s lost all of her savings, her 401k. So while you sit with your little white jacket on that somehow makes you feel like you’re a god, you should realize your human, and that you have faults. You can certainly blast someone else’s work and research, but where is any of your own? Show us how hospitals are getting safer, how people don’t leave sicker than they arrived, how MRSA isn’t spreading like a rash in hospitals, and how surgeons are so obsessed with being right, with keeping their status among their peers, that the patient comes second only to a doctor’s ego. You seem to have quite the ego, and I hope everyone who decides to go to you for surgery reads this to know you’re not there for patient care, to get the patient better, to return them well to their families. You’re there for prestige and a title, and you’re upset that title isn’t as magical as it once was. People see through doctors like you now, thanks to the power of the Internet. In fact, search the Philadelphia court system and really learn about Doctor Koka…

  3. I never liked Great Gatsby. But the one thing F. Scott Fitzgerald got right was this sentiment: “The test of a first-rate intelligence is the ability to hold two opposed ideas in the mind at the same time, and still retain the ability to function.”

    I understand Fitzgerald was an American.

    Am I alone in being troubled by the fact that many seem unable to countenance?

    a) Medical errors are a problem.

    b) The science of arriving at accurate estimates of error is deeply flawed.

    Those who are demonizing the author or asking for this post to be removed are affirming an unfortunate message. Which is that the patient safety movement is a religion, not a science.

    • I think another great American, Groucho Marx, said once:

      “Don’t confuse me with facts, my mind is already made up!”

  4. For the umpteenth time, if any of the patient rights commentators here read my post, I note medical error is a huge problem that we all need to work to reduce. I disagree with some of the assumptions that were made, and I reject the notion that every harm that befalls a patient in the hospital is preventable. I never said hospitals were full of gun toting individuals, I merely said that the idea that every patient harm is a preventable one leads to a culture of animosity/antagonism between doctors and patients that is unhealthy and not constructive. Since I spend 360 days of the year in the hospital taking care of patients, I think I might have a slight clue about patient harms. A much more reasonable, civil, non-inflammatory, non-pejorative back and forth can be found between me and Dr. James here: http://anishkoka.blogspot.com/2015/12/my-response-to-dr-james.html.

    I spend 99% of my time taking care of my patients and being a patient advocate…as you can hopefully tell from the following third party site ‘verified patient’ comment:

    Dr. Koka is a wonderful doctor and very good at listening to your problems. We never feel rushed. He goes beyond being more than a doctor. Makes you feel special and concerned. I wish he had an office in Reading, Pa. I feel he saved my Husband 3 times. He don’t fool around he get things done and makes the calls himself to get things going. I feel he is the best Heart doctor and friend. Thank you Dr. Koka and your staff. They are very special also and helpful. My husband said he has all the faith in the world in Doctor Koka.

    I’m fairly sure this will satisfy no one I’m trying to satisfy.

    My last words on the matter:

    “In questions of science, the authority of a thousand is not worth the humble reasoning of a single individual.”
    ― Galileo Galilei

  5. I ask the administrators of this website to take this blog down. It is not based on facts, but does have an element of furthering the harm medically injured patients, and their families, have suffered. Physicians, and physicians attorneys, speaking of the suffering and deaths of medically harmed patients this way is not acceptable. Continuing to stigmatize the medically harmed victims by calling them ‘frivolous’ when the real facts show otherwise is in very bad taste.

  6. Bless your heart Dr. Koka!! You are too smart to be so narrow minded. Yet I am not one bit surprised at your perspective on preventable medical harm. I will not waste my time or energy trying to prove you wrong. It is very clear in the words you speak, you have NO CLUE about preventable medical harm. For the safety of your patients, open your mind to the possibility the numbers ARE accurate and help us to improve them!
    You did your research to prove it wrong, that devalues your words.

  7. Very bad numbers..
    The number required trustworthy data to start with..: Finding anything verifiable as “the real number” is .. frankly impossible.

    In America medical records are entered into courts as evidence as the EXCEPTION TO THE HEAR-SAY RULE. < exploiting "The exception to the hear-say rule" has encouraged the mantra "if ya don't document it, it did not happen" << huge problem when looking for trustworthy facts about causation. Heck huge problems for providers at hand-off and beyond.

    Example of when things go very wrong for surgery patient:

    Patient is "out cold"
    Patient has no way to know if their trusted surgeon is even in the operating room, there is no way to tell if the surgery team are ALL qualified to perform their tasks, there is no way to tell if even basic safe surgery protocols are followed.. there is no way to verify much of anything documented as factual, and what is missing. And operative reports can take days, or weeks to be entered/closed. But once polished and shined up, operative reports will read like a textbook surgery.

    Who in their right mind would document anything "less than par"? or worse..?
    Finding a verifiable number is impossible simply because of exploiting "the exception to the hear-say rule" and cover up. As long as the "exception" is the standard of care, the number will remain buried
    Audio/video of operating rooms is the only way to see what is going wrong, and what is going right.. Patients have a right to know if their trusted surgeon and team are actually in the operating room, the right to know if basic safe surgery protocols are followed, etc..

    IMO, Trustworthy data may be near impossible to establish using records that permit omissions of material fact.

  8. Sadly, this editorial sounds remarkably paranoid and hysterical. I’m not a statistician, nor a clinician, so I will not debate the actual number of preventable deaths. What I will say is that Dr. Koka sounds very similar to Pat Lynch of the New York City Police Union in drumming up a completely false narrative that doctors are under siege by dangerous patients. Dr. Davidson’s murder is indefensible. But our hospitals are not filled with gun-toting family members of recently deceased patients looking for payback.

    My mother died at the age of 56 from a C. diff infection, complicated by the negligence of both her dentist and her physician. The former did not warn her that C. diff was a potential side effect of clindamycin and the latter prescribed medications that prevented her body from expelling the toxins putting her into sepsis only 6 days after her symptoms manifested.

    In the wake of her death, many in our family were filled with rage. But we chose – as Dr. James and many other advocates who have posted here did – to channel our grief and anger into changing the systemic issues that led to her death. Given CDC’s recent revised estimates that as many as 30,000 Americans die from C. diff alone, perhaps Dr. James’ numbers are much too low.

    It comes down the definition of preventable. C. diff was allowed to run rampant in healthcare facilities where it killed tens of thousands of elderly and immune-compromised patients for 30+ years. It’s only in the last decade that real efforts have been made to reverse the annual increase in death rates. Same for MRSA, CLABSIS, etc. The awareness raising and push to prevent these infections came AFTER patients and advocates get involved. AFTER transparency was forced on hospitals.

    I don’t hate doctors and I don’t want to demonize them. In fact, my father- and brother-in-law are doctors. I love my doctors. And I love, respect and appreciate all the doctors who are shoulder-to-shoulder with us to fight HAIs and other forms of preventable harm.

    To compare, even slightly, Dr. James, me or others patient safety advocates to Pasceri is not only a red herring but a deeply offensive one. I urge Dr. Koka to retract his comparison and apologize for its venal and reckless nature.

  9. What is the point of trying to malign patient safety advocates in your analysis of the number of deaths caused by medical errors? Dr. Koka, you list the connection three commenters have to patient safety work as evidence to “Paul’s point.” And then you and others imply that these people are mounting a campaign to compromise health care for their own “parochial interests.” This is nonsense. Dr. James is one of many patient advocates who work without financial backing of any industry or special interest. What’s more, there is little or no glory illuminating the aspects of our healthcare system that lead to preventable medical errors. The numbers are not justifiable-whether you use yours or Dr. James’s. The amount of money, time and influence the health care industry has compared to these singular patient safety advocates is so out of balance it is absurd to pretend otherwise. Detailing your scepticism of Dr. James’s personal experience is unwarranted and does not do anything to bolster your argument but does take a nasty and insensitive swipe at someone’s personal tragedy. Stick to the numbers, Dr. Koka.

    • Not at all trying to minimize the personal tragedy inherent in all these medical errors. I do think transparency is important. I’m told (understandably) that I am biased because I am a physician all the time. I do not take that as a personal affront. To be fair Dr. James has used his personal tragedy and story in his book and his deposition to congress, as well as on the web, as exhibit A in the problems with our health care system. I did not believe it inappropriate to comment on it… especially as one of the main points I’m trying to highlight is the rhetoric injected into preventable harms.
      Pointing out that some of the folks in this debate do stand to gain financially from certain positions is also not unreasonable? Or when we talk about transparency do you only think physicians need to be transparent?

      No intent to ‘malign’ folks. Lets get the number right and work on the problems we can agree on need to be fixed!

      • I introduced the phrase “parochial interests” which I do think offends some. But I stand by the phrase as all the stakeholders have them….and they can co-exist with good intentions…..and it is human nature to convince oneself that your primary concern is selfless even when one has parochial interests….whether they be power, prestige, or dollars.

        The key, as Dr. Koka points out (and as Dr. Hadler) has pointed out is to stand on good data and good methodology…..of which there is a surprising paucity of….even among our exceptionally smart and well educated medical policy debaters.

  10. Dr. Koka,

    You state in closing that it’s “in no one’s best interest” to inflate the number of medical errors in the U.S. While it may be unethical, it certainly is in the “interest” of some (politicians and policy wonks), who want to claim that our system is “broken” so it can be replaced by something of their choosing. Though not sure what we would change TO, but you can’t change something without convincing people that it’s “broken.”

    When I hear someone say there are “__ thousands of deaths due to medical errors” in the U.S., I am skeptical. Why? Because like you, I do not see anything on such a scale, and moreover, because I am an attorney AND a physician I look at potential medmal cases all the time from attorneys who seek out my opinion.

    Generally less than 10% of the supposed malpractice cases are actually something worth pursuing. If indeed there were 400,000 people per year being killed by the healthcare system every year, and these were all “preventable,” (as claimed) then all the lawyers would be billionaires.

    I could certainly stop working 15 hrs a day practicing medicine, and just sue doctors and hospitals.

    • “Generally less than 10% of the supposed malpractice cases are actually something worth pursuing.”

      Glad to see that because for years doctors have been claiming medical tort system is “broken” and they need protection. Another myth conquered.

      • There have been many things wrong with the medical tort system. Defensive medicine is expensive, many patients and attorneys have a “jackpot justice” approach, and malpractice premiums were rapidly increasing, though now they have leveled off, and in some instances gone down.

        For the most part, doctors do well at actual trials, generally because they are well-represented, and because they (and their attorneys) don’t take a case to trial where there is obviously an error.

        But in the early 2000’s we had literally every doctor in my state hit with MULTIPLE malpractice suits. Every one. Why? Because a jury in a rural area awarded a huge verdict against Johnson & Johnson, for Propulsid. That caused a landslide of cases where individual physicians, not just drug makers, were sued. We had kindly family doctors with a hundred lawsuits for prescribing drug(s) that was not only FDA approved, but clearly indicated (statins, Cox-2 agents). This resulted in a backlash of “tort reform,” and now my state has caps on non-economic damages, venue changes, and other measures.

        But the biggest single blow to this mass litigation was a single state supreme court ruling, that said basically if you want to sue a doctor, then you had to sue him/her in his own county, and not 300 miles away as part of a giant mass tort action against a medical device or pharma entity. The litigation explosion went pooof and dropped back to pre-explosion levels.

        Malpractice premiums dropped, and the doctor drain also reversed. There are still frivolous cases, but not as many, because it takes time, money, and an expert to prove causation.

      • BTW Peter,

        if 90% of the supposed “malpractice” cases are without merit, doesn’t that indicate a problem? Not really sure this conquers a “myth.”

        Admittedly this rough figure includes POTENTIAL cases, where perhaps a suit has not been formally filed, but obviously the patient feels wronged, and has sought out an attorney, and the attorney has spent time and money evaluating the case, and hired someone to further evaluate it for a violation of the standard of care.

        Often times, the case has ALREADY been filed (due to SOL timeframes) and now the plaintiff’s are hoping to bolster their case with supporting opinions. Every case that gets filed costs an estimated $30,000 (per the defense bar, not per me).

        • lawyerdoctor, the cost hurdles you point out to launching a case should, in of their own, dampen mal/med claims since these lawyers only charge if the case is settled – not necessarily won.

          I am generally an opponent to so called tort “reform” that denies people their legal ability to get compensation. Contingency (and class action) gives poor people access to the legal system. Just because a case does not have “merit” may only mean it will not pay enough to the lawyer. What goes missing is all those legit claims for smaller amounts.

          I’ve never seen a direct link between tort choking and lower medical bills – the case that seems always to be made.

          • Let me clarify a bit, it doesn’t cost the PLANTIFF $30,000 to initiate the suit, it tends to cost the defense (per their own data, not mine) that much.

            True, it does cost some $ to bring a case, “legit” or otherwise. This is as it should be, in my opinion, because it is a big deal to file a malpractice suit, a big deal to defend one, and should not be undertaken lightly. There are certainly some legitimate cases whose damages are very small and thus not “worth” taking to a trial. Often times these are filed, or sometimes even a demand is made, and then settled.

            I think most doctors would be fine with more of a “no fault” system, perhaps like worker’s compensation. But the largest opponent of this is the trial bar, who want the chance at the 7-8 figure jury award. We have seen a trend toward arbitration in med mal, it’s kind of too soon to see how these are going, but again, there is often opposition from the plaintiff’s bar.

            Wrong site surgeries, “never events,” and the like do happen. But these are less than 1% of all medmal claims. They are the plaintiff’s attorney’s dream. Doctors feel they are under assault, since even to have a claim filed against you is to lose. Taking a medmal case to trial means years of hassle, lost sleep, productivity, depression, impact on your life and marriage, and impact on your practice. And that’s if you win the case.

            To your final point about the relationship between tort reform and lower costs, I think there is SOME evidence (it is varied and oft-disputed) of a relationship between “reforms” and stabilization of med mal PREMIUMS. There seems to be scant data over whether “reforms” result in lower “defensive medicine” costs. This would seem to entail a much larger scale and perhaps even require a total “culture change” from the vastly defensive posture that doctors are almost required to take at present.

          • “True, it does cost some $ to bring a case, “legit” or otherwise.”

            I launched a suit against the county I lived in. Did it pro se. Did research at the local university law library and a “be your own lawyer book”. Only cost me filing fees and the cost to have the papers served. What I found was the expensive part in suits is the discovery process. Fortunately I did all my own discovery before I filed the suit. Consequently the county decided not to defend the suit and I won with summary judgement and got everything I asked for.

            How much discovery does the plaintiff’s lawyer have to do before filing?
            How much discovery does the defendant have to do to determine if settlement or court?

  11. Thank you, Dr. Koka. Finally, someone is taking the time to dismantle this ridiculous myth. I read that same paper last week and in additions to being floored by the flawed methodology (wouldn’t pass muster for a 6th grade science experiment), I was incensed at the so called “journalists” who parrot this pablum. It’s not even possible that medical errors are the 3rd highest cause of death in the US. I am also finishing a paper that takes apart the the IOM joke that started all of this nonsense. “To Err is Human” is the biggest piece of trash science I’ve ever encountered. (a) most of the data most were at least ten years and some more than twenty when the paper was published- (b) much of the data is taken from studies in foreign countries (c) “errors” were defined as everything from non-compliant patient, to first time allergic reaction, to treatment prescribed that was not in the guidelines. Please keep outing this ridiculous attack on doctors.

  12. To Paul’s point..

    Susan Shinazy – Suzan Shinazy, retired RN, founder of Medical Error Transparency Plan, Patient Safety Advocate with California’s Consumers Union Safe Patient Project

    Lisa McGiffert directs the Safe Patient Project

    DAN WALTER Dan Walter is the author of Collateral Damage: A Patient, a New Procedure, and the Learning Curve, a compelling behind the scenes look at the corrupting corporate influence on America’s health care system. Dan has served as Communications Director for US Senator Herb Kohl and the American News Network. He has worked as a political consultant with Democratic strategist Joe Trippi. He is a member of the Consumers Union Safe Patient Project, collaborating with patient safety advocates to reduce harm from preventable medical errors.

  13. Dr. Koka, maybe it doesn’t ‘feel’ like patients are dying to you because it hasn’t happened to you or your loved ones…but since medical errors are the 3rd leading cause of death, you (or your family) probably will experience it in your life time. Then, maybe you will do some real research. Denial, and looking the other way, will not bring solutions.

    • Thanks Susan, I guess my point is that I’m not clear that number is really evidence based. I have done some research, I have read the same papers Dr. James has read. I’m not denying medical errors, and say so in my blog. So I’m confused by your response. Did you read my post in its entirety? Like I’ve said elsewhere, I respectfully degree with the assumptions that Dr. James has made in coming up with his number.

      • Lol. You ask if I read your post in its entirety. This shows how well you respectfully disagree. That was arrogant and condescending and usually resorted to when one has no facts to back up their argument.

  14. This blog is essentially trying to obfuscate the fact that hundreds of thousands of people are unnecessarily harmed by medical care every year by focusing on how many can be prevented. This is a common tactic by those who would rather dismiss the problem by saying “can’t do it” than focus on preventing every error and infection — not just those that someone has deemed preventable. The author criticizes Dr. James’ preventability estimate, but I would question anyone who says they KNOW how many are preventable. While the preventability is sometimes studied scientifically, it is mostly subjective unless one truly drills down to each individual patients’ every condition. Most importantly, preventability changes with time. Who would have ever believed, based on the experts’ assessments 20 years ago, that hospitals could reduce CLABSIs in the ICU by 50%?
    I would also quibble with his assessment of the 3 studies cited by John James. They were solid — using medical record extraction (the gold standard) with a review by health care professionals. The remarkable thing is that each study came up with very similar results: one in 4, 27%, one in 3 hospital patients are harmed. These studies are a lot more relevant today than the ones previously cited by the IOM (using data from the 1980s) that most everyone was using before Dr. James’ study came on the scene.
    Dr. James put it best in the conclusion section of his study: “In a sense, it does not matter whether the deaths of 100,000, 200,000 or 400,000 Americans each year are associated with PAEs in hospitals. Any of the estimates demands assertive action on the part of providers, legislators, and people who will one day become patients. Yet, the action and progress on patient safety is frustratingly slow; however, one must hope that the present, evidence-based estimate of 400,000+ deaths per year will foster an outcry for overdue changes and increased vigilance in medical care to address the problem of harm to patients who come to a hospital seeking only to be healed.”

    • Thanks for the comment. I’m not denying the importance of medical errors and I also note in the latter part of my post about why the rhetoric and number matters, and why a toxic environment which turns patients against doctors isn’t ideal. By the way, I have no quibble with the 4 studies that Dr. James cited, my quibble is how Dr. James then extrapolates from those studies to come up with his number. And your post makes my point in terms of rhetoric. You are right about the number of total harms (Landrigan – 588 total harms / 2341 total patients)..About ~360 were deemed preventable (15%). You are suggesting all 588 harms can be prevented, I guess? I would disagree. I would argue we need to define and focus on the 15%. And if medicine progresses to make more of those preventable…great! In my post I do applaud Dr. James for bringing attention to this important issue. I don’t believe our interests are misaligned here…

      • Thanks for your reply – I addressed some of the prevention issues in my other reply above. I’m suggesting to focus on prevention, not the science of figuring out how many errors are preventable.

      • But you are wrong, Dr. Koka. Dr. James does irreparable harm with his magical thinking. We are allowing a man blinded by rage take down a wonderful group of talented and caring professionals. He said it HIMSELF, all of his measures are SUBJECTIVE. This means they cannot be quantified. Stop letting this go unchallenged. The man is making up outrageous numbers. And most importantly, in these so called harms– no one can get inside the doctor’s head. No one knows if the treatment choice was the lesser of two evils. No one knows if perhaps the patient was given a drug with some known side effects because of an allergy to the “guideline” treatment. No one knows if the harm that results to a patient isn’t a much lesser harm that what would have occurred if the patient didn’t receive that treatment. You get chemo– your hair falls out and you get sick. You don’t get chemo– you die. And no one took out or controlled for first time allergic reactions to a drug. These things happen all the time. They are neither preventable, nor errors. I am sorry for this man’s son. It would make me burn with rage also. But we need to use some common sense.

        • Yates…fantastic! I try to be conciliatory in my comments about those who exaggerate and misinterpret the data to support their aims….but this ends up minimizing the “irreparable harm” being done to the medical system. and Dr. James is only one example of the legions of health care “reformers” who do it.

    • ” it does not matter whether the deaths of 100,000, 200,000 or 400,000 Americans each year are associated with PAEs in hospitals” This comment sets my hair on fire. It DOES mater if its 100.000 or 400,000. In any decent clinical trial this study as well as its conclusions would be thrown out. The FDA would be knocking at your door for an explanation. As the doctor said, he is not denying that medical errors happen. We need to prevent them. But don’t belittle the science by making up a number and defend by saying, “well it doesn’t really matter what the number is.” Also, a bad outcome is not the same as an error. Medical complications and side effects are just that. They are known complications that happen sometimes and often cannot be prevented. lets work on the real problem and drop they hysteria. Dr. Koka wrote a very thoughtful, respectful response to the craziness.

      • I would hardly call the response of the health care system, policymakers or the public “hysteria” — the point of the quote in my post is that basically, for decades 98,000 deaths (IOM number) was alarming enough and these three solid studies have documented errors — NOT complications that could not be avoided. And they also documented harm that did not result in death. Harmed patients often suffer debilitating pain, years of treatment and rehabilitation, and sometimes lose their jobs, their homes, their lives because of it. When you look at the harm – from minor to major – it is easily in the millions. So, yes, let’s focus on preventing those harms and not on figuring out which ones cannot be prevented. For example, some would say infections in cancer patients are not preventable because of their compromised immune system — yet there are hospitals and doctors who are preventing infections in these patients. In practice, physicians and other health care workers must have a mindset that every infection can be prevented – without that, there will always be excuses. And further, let’s quibble about those when we get a little bit closer to zero than 722,000/year — on any given day, one in 25 hospital patients infected.

  15. A very defensive piece by Dr. Koka. “As a busy clinician who spends much of his time in the hospital, it doesn’t feel like patients are dying daily because of medical errors.” That’s likely because most of these errors are explained away as “complications” and swept under the rug. My guess is that if the truth were told, Dr. James’ estimates would be conservative.

  16. Dr. Koka has thoughtfully critiqued the James paper. What a shame that he then goes off the deep end with a straw man rant: “No, we’re not incompetent and no, not every error is preventable, no matter what ‘they’ say.”

    Who, exactly, would “they” be? Not, surely, any peer-reviewed paper I’ve ever seen on this topic over the past 20 years. Not what Donald Berwick, MD or Lucian Leape, MD or David Blumenthal, MD or any of the other leaders of this movement have been preaching. Not by CMS, which is very careful in its error definition. And, by the way, not by the U.S. Congress, that one small, ill-attended, hardly noticed hearing notwithstanding.

    In 2012, I reviewed the evidence in a post for The Heath Affairs Blog: “The Toll of Preventable Errors: How Many Dead Patients.” See: http://healthaffairs.org/blog/2012/03/09/the-toll-of-preventable-errors-how-many-dead-patients/. It shows, by the way, that AHRQ has looked very carefully at the evidence and comes up with about 100,000 preventable medical errors in hospitals alone each year.

    I am puzzled but the purpose of this blog post. Is the conclusion that if “they” would just leave us alone, all would be OK? That the entire patient safety movement is based on a myth? If those are the implications, then Dr. Koka, like his colleagues Dr. Samuels and Dr. Handler, has no earthly idea what he is talking about and is simply spouting off, a guy with an MD after his name who doesn’t care about the medical literature but likes to write blog posts in which he is victimized by “them.” (See my reply in this space to Dr. Samuels and Dr. Handler, based on the evidence.)

    I don’t think the 400,000 number is accurate, either, and I appreciate Dr. Koka’s work in analyzing it. I invite him to look at other original work in this area and to participate in a serious discussion of preventable harm and its prevention.

    • Dr. Millensen thanks for the review. The purpose of the blog post was as noted to point out rhetoric and impressions matter. I do applaud Dr. James, and other patient advocates for attention to this issue. And no, I don’t believe, that we should just be left alone to do as we please. I absolutely believe preventable harms happen, and we as care givers need to keep working to reduce these harms. Leaving/giving the impression that every death that happens in the hospital is a preventable (not I’m sure yours or Dr. James’ intent) one, doesn’t serve anyone very well, and antagonizes the doctor patient relationship. We all need to work together to reduce patient harms. Patient safety is not a myth, and I don’t take it lightly. I say as much in my post:

      “Medical errors are a serious problem, that is no doubt deadly, and needs attention. We in the healthcare community need to work hard locally and nationally to combat this issue. I applaud Dr. James and the other physicians that have shed light on this important issue.”

      I would love to continue the conversation if you’d like. Twitter handle: @anishkoka

      • A medical error or a bad outcome? Seriously. Do you think those of us who have spent years working to make small changes within the medical system in memory of lost loved ones, in my case, my daughter, don’t know the difference? I have spent 13 years trying to get continuous post op monitoring for patients on opioids, like Fentanyl, the standard of care. My healthy 12 year daughter was literally euthanized while recovering from elective surgery. That was a bad outcome resulting from an error that still exists in hospitals today.
        The only very bad numbers are usually the ones that are people we love. Sadly, the system seems to work that way. It’s only a number until it’s your child or spouse.

  17. We’re getting more scientific than these concepts can encompass. Just studying the causes of cell death has occupied thousands of papers. When an entire organism dies, who really can describe the precise cascade of events that takes place? Was it an electrolyte? Or a receptor? Or a QT interval? Bcl2 intracellular proteins? Or a adverse drug reaction? Or a genetic vulnerability? It is too easy to say that someone was responsible.

    “Animal cells can activate an intracellular death program and kill themselves in a controlled way when they are irreservsibly damaged, no longer needed, or ar a threat to the organism.””Thousands of caspase substrates have been identified. Which ones are critical proteins that must be cleaved to trigger the major cell remodelling events underlying apoptosis”? Molecular Biology of the Cell, 6th Edition.

    This is just one teeny slant on the problem.

    “Cause of Death” , during our current era, does not have precise meaning..

    • Agreed….to further support your point:
      Nortin Hadler M.D. (UNC) quote: “We have been more than misled by proximate cause epidemiology; we have been brainwashed. Furthermore, we have accepted an enormous transfer of wealth in a misguided approach to preventing disease and promoting health.”
      Citizen Patient page 124 (2013 UNC Press).

      • Paul, I think you are confusing to different viewpoints. Dr. Hadler writes about our paranoid over medicalization, while Anish Koka speaks to getting the numbers right while not discounting the need to be watchful on medical errors.

        Medical errors are just not those which cause relative instant death, but those subtle errors which chip away over time.

        • Peter,
          Hadler’s Citizen Patient goes beyond his previous works to look at the systemic and institutional interests who, as he says, have “mastered the language of philanthropy” to pursue their own parochial interests…..and his quote about “proximate cause [of death]” is about how these interests don’t hesitate to use poor methodology and poor data to pursue their parochial agendas. I think this is directly pertinent to Dr. Koka’s piece…..in that many players are readily trying to use John James Ph.D faulty analysis to gain influence, political power and financial resources.

          • “in that many players”

            Who would those “players” be? Seems the players for Hadler are different than those of Koka.

          • Peter,
            Koka is pointing out a specific case that illustrates Dr. Hadler’s general observation in Citizen Patient that in far too many aspects of medicine that there is a paucity of good information (based on solid data and studies done with adequate methodology) and therefore far too often interested parties will do what Koka
            points out: in this case “leading members of our profession have unfortunately whipped our representatives and the general public into a frenzy” (quote from Koka piece).

            The only “player” (the term I used) he directly names in this piece is Bernie Sanders. He doesn’t name the others. I have not studied the lobbyists and think tanks that work the medical error domain…many or most I am sure are well-intentioned….but I would bet a dollar that the tort lawyers are deep into it and delighted to help stir the frenzy.

          • Well I doubt lawyers are quoting Hadler. I get a nervous about back handing medical errors as so much public frenzy. I’d like to get the real numbers and go from there rather than dismiss everything as a lawyer concocted lie – as those in the medical profession would like.

          • Don Berwick, Lucian Leape, and Troyen Brennan made a nice fortune out of this kind of fear mongering.

      [Homage to Sir Thomas Browne]

      Shall I tell you once more how it happens?

      Even though you know, don’t you? You were born with the horror stamped upon you, like a fingerprint. All these years you have lived you have known. I but remind your memory, confirm the fear that has always been prime. Yet the facts have a force of their insolent own.

      Wine is best made in a cellar, on a stone floor. Crush grapes in a barrel such that each grape is burst. When the barrel is three-quarters full, cover it with a fine-mesh cloth, and wait. In three days, an ear placed low over the mash will detect a faint crackling, which murmur, in two more days, rises to a continuous giggle. Only the rendering of fat or a forest fire far away makes such a sound. It is the song of fermentation! Remove the cloth and examine closely. The eye is startled by a bubble on the surface. Was it there and had it gone unnoticed? Or is it newly come?

      But soon enough more beads gather in little colonies, winking and lining up at the brim. Stagnant fluid forms. It begins to turn. Slow currents carry bits of stem and grape meat on voyages of an inch or so. The pace quickens. The level rises. On the sixth day, the barrel is almost full. The teem must be poked down with a stick. The air of the cellar is dizzy with fruit flies and droplets of smell. On the seventh day, the fluid is racked into the second barrel for aging. It is wine.

      Thus is the fruit of the earth taken, its flesh torn. Thus is it given over to standing, toward rot. It is the principle of corruption, the death of what is, the birth of what is to be. You are wine…

      Dead, the body is somehow more solid, more massive. The shrink of dying is past. It is as though only moments before a wind had kept it aloft, and now, settled, it is only what it is— a mass, declaring itself, an ugly emphasis. Almost at once the skin changes color, from pink-highlighted yellow to gray-tinted blue. The eyes are open and lackluster; something, a bright dust, had been blown away, leaving the globes smoky . And there is an absolute limpness. Hours later, the neck and limbs are drawn up into a semiflexion, in the attitude of one who has just received a blow to the solar plexus.

      One has…

      Examine once more the eyes. How dull the cornea, this globe bereft of tension. Notice how the eyeball pits at the pressure of my fingernail. Whereas the front of your body is now drained of color, the back, upon which you rest, is found to be deeply violet. Even here, even now, gravity works upon the blood. In twenty-four hours, your untended body resumes its flaccidity, resigned to this everlasting posture.

      You stay thus.

      You do not die all at once. Some tissues live on for minutes, even hours, giving still their little cellular shrieks, molecular echoes of the agony of the whole corpus. Here and there a spray of nerves dances on. True, the heart stops; the blood no longer courses; the electricity of the brain sputters , then shuts down. Death is now pronounceable. But there are outposts where clusters of cells yet shine, besieged, little lights blinking in the advancing darkness. Doomed soldiers, they battle on. Until Death has secured the premises all to itself.

      The silence, the darkness , is not for long. That which was for a moment dead leaps most sumptuously to life. There is a busyness gathering. It grows fierce.

      There is to be a feast . The rich table has been set. The board groans. The guests have already arrived, numberless bacteria that had, in life, dwelt in saprophytic harmony with their host. Their turn now! Charged, they press against the membrane barriers, break through the new softness, sweep across plains of tissue, devouring, belching gas— a gas that puffs eyelids, cheeks, abdomen into bladders of murderous vapor. The slimmest man takes on the bloat of corpulence. Your swollen belly bursts with a ripping sound, followed by a long mean hiss.

      And they are at large! Blisters appear upon the skin, enlarge, coalesce, blast, leaving brownish puddles in the declivities. You are becoming gravy. Arriving for the banquet late, of course, and all the more ravenous for it, are the twin sisters Calliphora and raucous Lucilia, the omnipresent greenbottle flies, their costumes metallic sequins. Their thousands of eggs are laid upon the meat, and soon the mass is wavy with the humped creamy backs of maggots nosing, crowding, hungrily absorbed. Gray sprays of fungus sprout in the resulting marinade, and there lacks only a mushroom growing from the nose.

      At last— at last the bones appear, clean and white and dry. Reek and mangle abate; diminuendo the buzz and crawl. All, all is eaten. All is done. Hard endlessness is here even as the revelers abandon the skeleton.

      You are alone, yet again.

      Selzer, Richard (1996-04-15). Mortal Lessons: Notes on the Art of Surgery (Harvest Book) (Kindle Locations 1368-1483). Houghton Mifflin Harcourt. Kindle Edition.

  18. Thanks for the comments. I have to say, the title here is not mine. I have corresponded with Dr. James and I do respectfully disagree with him on the assumptions he made in his paper. No question medical error is a problem, we as a community need to combat it. Paul raises an excellent point about who does have an interest in making these claims.

  19. Excellent analysis…thank you.

    You end with the statement “The number we use today, 400,000, is a made up number. It is based on a feeling. Using this to falsely indict, demoralize, and create a toxic environment for millions of medical providers is in no one’s best interest.”

    But yes, it is in the interest of some: social engineers in the govt sector (bureaucrats) and in the non-profit sector (think tank gurus who devise ways to tinker with the system) and private sector players (consultants, E.H.R. providers etc)…..and let’s not forget the sorry state of medical journalists who love to cry wolf and then move on to the next poorly analyzed hyped up scare story or fad.

    Here is my previous THCB contribution that works the issue:

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