THCB

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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legacyflyerMadicyn@RogueRadleahslegacyDeena_Sowa_McCollum_BSN_RN Recent comment authors
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legacyflyer
Member
legacyflyer

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… Read more »

Madicyn
Member

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… Read more »

Peter
Member
Peter

Madicyn, ever think about paragraphs? Too long winded and tiring for most to read.

@RogueRad
Member

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… Read more »

lawyerdoctor
Member
lawyerdoctor

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

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

anishkoka
Member

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… Read more »

SuzanShinazy
Member

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.

Deena_Sowa_McCollum_BSN_RN
Member

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.

Danny4596
Member

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… Read more »

Christian_John_Lillis
Member

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… Read more »

srhenry
Member
srhenry

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… Read more »

anishkoka
Member

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… Read more »

Paul @ Pivot ConsultingLLC
Member

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.

lawyerdoctor
Member
lawyerdoctor

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?… Read more »

Peter
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Peter

“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.

lawyerdoctor
Member
lawyerdoctor

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… Read more »

lawyerdoctor
Member
lawyerdoctor

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… Read more »

Peter
Member
Peter

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… Read more »

lawyerdoctor
Member
lawyerdoctor

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… Read more »

Peter
Member
Peter

“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… Read more »

Yates
Member
Yates

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… Read more »

anishkoka
Member

Well said here, and elsewhere. Do you have a twitter handle? or other contact info?

anishkoka
Member

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… Read more »

SuzanShinazy
Member

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.

anishkoka
Member

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.

SuzanShinazy
Member

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.

lmcgiffert
Member
lmcgiffert

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… Read more »

anishkoka
Member

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… Read more »

lmcgiffert
Member
lmcgiffert

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.

Yates
Member
Yates

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… Read more »

Paul @ Pivot ConsultingLLC
Member

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.

Yates
Member
Yates

” 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… Read more »

lmcgiffert
Member
lmcgiffert

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… Read more »

danwalter
Member
danwalter

Here’s an account of that Senate hearing: https://www.beaconreader.com/dan-walter/carmageddon-and-statistics