Exhibit A on how hubris in medicine can be deadly…Let’s take a time out for skepticism

Thanks for all the support on my last post. It’s striking how sometimes pointing out the obvious gets a lot of attention. I have a quick follow-up post. The purpose is to show you a real-life and current example of how medical hubris might have killed thousands of patients.

My friend and colleague, Dr. Wes Fisher, sets it up with an important comment on my last post. In good medical blogger fashion, it was short and to the point:

This post [on hubris] 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?

Obviously, Wes is worried that guidelines, protocols, and checklists are taking over the practice of Medicine. Established medical practice is no longer just a suggestion, it is morphing into law. There is now great risk in being a practicing skeptic. (Just try stopping a patient’s niacin or fish oil.) But these edicts, which must be followed for quality medicine to have occurred, are human-created and subject to the test of time. The study I just reported shows that 40% of established medical practice gets reversed.

Wes’ comment was made three days ago. This morning I woke to a news flash from another friend, Larry Husten, a journalist specializing in heart news. Larry writes that European Heart guidelines based on disgraced research may have caused thousands of deaths. OMG. This is a real world story of hubris.

Here is my translation. The medical issue deals with how best to lower the risk of heart attack after surgery. Numerous studies done a few years ago showed that giving a drug called a beta-blocker, (which blocks adrenaline’s effect on the heart) might be protective. Alas, the concept made sense. And, as Larry tells us, “the strongest evidence in favor of this strategy came from the DECREASE series of trials.” Other trials were less conclusive and one even suggested a trend toward higher death rates. You could sum it up by saying the issue of pre-operative beta blocker use wasn’t clear. This is where the story gets egregious.

The first fact of the case was the discovery that the principal investigator of the DECREASE trials was involved with a scientific misconduct scandal. The second fact was that the disgraced Dutch researcher was the chairman of the committee that drafted the guidelines for pre-op use of beta-blockers. It was not surprising then that his trials were favored, and pre-operative use of beta-blockers was written into the guidelines. Doctors follow guidelines.

But…A most recent meta-analysis of all pre-op beta blocker trials, excluding the dubious DECREASE data provides scary data. The new analysis, without DECREASE, showed a statistically significant increase in death in the group of patients treated with pre-op beta blockers.

The European Guidelines, to this day, still recommend pre-op beta blockers. The authors of the most recent meta-analysis estimate that millions of procedures in the UK alone are performed in which beta-blockers are recommended. And based on the new findings (a 27% increase in death), they estimate the possibility that thousands of deaths might have occurred because “physicians faithfully followed guidelines.”

This is exactly what I am talking about. The science wasn’t clear but yet medical practice was driven by eminence-based practice. Doctors just got in line and followed the expert advice.

Sure, there will be an emergency meeting of the guideline writers and this mistake will be corrected. The mistake will be sold as a case of a single doctor’s misbehavior.

I disagree. The real problem here is deeper than a single miscreant. Legions of doctors no longer critically look at the science themselves. Not only don’t they have time, but many feel that even if they did study the science and came up with their own interpretation, they wouldn’t be allowed to go against the almighty expert guideline. They just take the word of expert opinion. Experts are smart, right?

But as Wes points out, hubris in medicine gets magnified when it is practiced by the ‘experts’ and the guideline writers. For in this day, entire quality and compliance departments exist to see that doctors stick to guidelines and protocols. Oh my, oh my, does it get crazy when the guideline writers don’t see their own hubris. Imagine that…Following rules that were wrong. Get that HDL up with pills, adjust those female hormones, put in ear tubes, and don’t even get me thinking about Multaq.

The checklist people like time outs. I say it’s time to call a time out on irrefutable guidelines and protocols. Call it a time out for uncertainty and skepticism.

JMM

15 comments

  1. So, guidelines are formulated by consensus based on the good faith research of well renown investigators. Governments quickly incorporate these guidelines into quality assessment protocols. Doctors who deviate from the protocols may be subjected to penalties. Lawsuits involving deviation from these guidelines almost always end up going very badly for the practicing physician.

    So we are trapped into this Catch22 because of hubris?

    Just whose hubris are you talking about?

  2. Thanks for this!

    There has been a similar problem for older adults for some time. Data derived in younger patients without multimorbidity but guidelines written for all.

    Thoughts like this seem to be getting louder and more frequent. I feel like these messages may indeed bring the art back to medicine.

  3. John – bravo. You can’t give doctors guidelines and protocols, penalize them if they deviate from them, and yet ask them to be up on the latest research. Standard of Care is a powerful and dangerous weapon.

  4. Honestly – medical professionals have all but asked for guidelines, checklists, and one size fits all medicine when they decided that caregivers are interchangeable parts.

    If we can switch caregivers based on the time on the clock instead of the status of the patient, we have to make things standardized so that anyone can step in and pick up where the last person left off.

    We can have highly skilled continuous individualized care, which can can be brutal on work-life balance and is increasingly difficult as medicine gets more complicated.
    …or…..
    We can have a standardized system of checklists and interchangeable parts, which can be frustrating for the ‘cowboys’ and harmful to patients, but is easier to administrate, staff, and bill for.

    It’s tough (impossible?) to enjoy the benefits of both.

    On the substance of the article – actual scientific understanding moves slowly, evolving according to the preponderance of the evidence and seldom changing substantially with a single peer reviewed article. It’s more of a big ship being slowly steered than a jetboat speeding from spot to spot. Anyone who has written and reviewed those papers realizes that the system is far from perfect. Chasing the latest article with the latest list of guidelines is always going to be a foolish exercise.

    A problem – it’s easier to get the next grant if you can point to how important and consequential your last study was. There is little credit given for work whose wisdom became obvious many years later.

  5. Thanks, John, for the nice words about my story. I think we need to be very careful, though, not to mix up very different problems. It seems to me that the ESC perioperative beta blocker guidelines story is fundamentally about the pernicious effects of scientific misconduct and the inability of the scientific establishment to fully address these effects in a timely and aggressive manner.

    The Mayo Clinic Proceedings article was about something else, and I don’t think it’s all that helpful to lump the two together. Uncertainty or lack of evidence is not the same as tainted evidence.

    1. Thx Larry. I thought about that. I’m glad you brought it up. I get mixed up a lot.

      You make a good point. There are two mechanisms going on here. But I am sticking with the premise that the medical establishment must more openly face up to uncertainty. Whether it’s flawed science, inadequate science, dated science or fraudulent science, the fact remains that each doctor must grow more humble and transparent about the limits of what we can do.

      I’m for minimally disruptive medicine. Right now, in the US, we have maximally disruptive medicine.

      When we blindly adhere to guidelines, that we know flawed humans have written, we minimize the art of this beautiful endeavor to help people.

    2. The irony is that in the very short period of time between John’s posts, one of the “reversals”, the one dealing with oral leukoplakia, has been “re-reversed” because the NEJM article it was based on has been retracted due to possible falsification of the data.

      How many more re-reversals might we anticipate?

      1. How about numbers 25 and 26 for re-reversal?
        The researcher who decided it’s better, because of “outcomes”, for ANYONE to have perpetual rate-controlled atrial fibrillation rather than sinus rhythm – however achieved – has clearly never experienced AF happening to his own body.
        What about the patient? His Quality Of Life? HIS preference for his remaining time? The patient must be factored in to the science.

        Dr. John, I’m wondering how you feel about this one in your enlightened capacity, having been an AF patient yourself. ??

        1. Yes, like the one about the pediatric ear tubes. It appears that the data shows that the ‘outcome’ (ie. preventing hearing loss) is not being achieved. But is that the only outcome worth measuring? What about the suffering of the child and the sleep deprived parents?

          1. Sorry. Poor phrasing. It should read “It appears that the data show that the ‘outcome’ (preventing hearing loss) is not affected by the use of ear tubes.”

          2. You and I both know that insurance companies will jump on this study with all fours and use it to deny authorized PE tubes under any circumstances. My children sure felt better after they got them, though.

        2. Jeff – Those studies of rate control vs. rhythm control also report that some people quit the rhythm control drugs because they can’t tolerate the short-term symptoms and side effects (to say nothing of long-term issues like lung damage, liver or thyroid or eye damage, or catastrophic arrhythmias). At least one study has measured quality of life and did not find that rhythm control was superior, on average. If you (a) have severely symptomatic AF/AFL and (b) rhythm control drugs work for you, there may be a quality of life benefit that’s worth an added risk. It’s hard to say the same for people who have *asymptomatic* AF/AFL – whose experience may be less typical than yours, but equally valid – and who are subjected to efforts to coerce them onto Tikosyn or sotalol because “sinus rhythm is better”.

          1. Right. Well said.
            I was hoping to elicit the notion that ablation ought to be a first line option – as soon as the AF is diagnosed. Time misdirected in attempting EITHER rhythm or chemical sinus control can lead more quickly than expected to difficult-to-overcome remodeling challenges to ablation.

            I notice that ablation doesn’t appear on the list at all. Interesting.

  6. Please forgive me for posting this twice. It’s so important….

    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.

  7. Hubris is among the most dangerous of sins. Just look at nixon and how well it went for him. Somdtimes being right in the moment by the trust in conventional wisdom or “being the best at practicing evidence based ” may lead to disastrous outcomes. Questioning convential thought is both the art of medicine and the other side of tfhe dangerous reliance on ” evidence based medicine” . The balance of our natural tendency as physicians to hubris is dangerous in both extremes. The hope lies in the ability to detect when ones particular question lies outside the realm of what is known yet we still need to make a decision based on our gestalt. Hubris is always the threat from good outcomes based on little more than luck. Think once if you are going to follow the guidelines and think twice if you do not. A good outcome is good fortune and a bad outcome is often fate . We are just not that important.

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