How I learned to stop worrying and love practicing without EBM

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If you’ve enjoyed my previous take-downs of evidence-based medicine but can’t let go of your attachment to the randomized controlled trial, this post is for you.

My aim is to show you practical ways you can safely and effectively exercise clinical judgment without recourse to “evidence-based” knowledge, provided you follow simple but fundamental principles of clinical care: circumspection, parsimony, and due respect to patient autonomy.

What’s more, I will make my case against RCTs using examples that EBM apologists have precisely identified as paradigmatic of this “single greatest medical advance.”

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Three cheers for the statin war

The days of healthcare utilitarianism are numbered!

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If anyone has any lingering doubts that the promises of evidence-based medicine are quickly evaporating, the recent blog post by Larry Husten on the statin war should quickly dispel them.  Husten gives an excellent account of the latest battle opposing the pro- and the anti- camps.

What happened?

The pro-statinists published a 30-page diatribe in The Lancet.  Statins save lives, they assert.  The evidence is incontrovertible.  Yes, they can have side effects such as muscle pain, no one disputes that.  But drawing attention to those side-effects—as the anti-statinists do—endangers patients who now find a reason to refuse to take the life-saving drugs.  There’s evidence of that happening.

The anti-statinists voiced their position in the BMJ.  Statins cause muscle pain and fatigue, they assert.  The evidence is incontrovertible.  Yes, they can save lives, no one disputes that.  But trumpeting the benefits or down-playing the harm—as the statinists do—prevents patients from partaking in the glorious activity of “shared-decision making.”  There’s evidence of that happening.

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A free market repudiation of evidence-based medicine

A response to Andrew Foy

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In a recent article entitled “A Hayekian Defense of Evidence-Based Medicine” Andrew Foy makes a thoughtful attempt to rebut my article on “The Devolution of Evidence-Based Medicine.”  I am grateful for his interest in my work and for the the kind compliment that he extended in his article.  Having also become familiar with his fine writing, I return it with all sincerity.  I am also grateful to the THCB staff for allowing me to respond to Andrew’s article.

Andrew views EBM as a positive development away from the era of anecdotal, and often misleading medical practices:  “Arguing for a return to small data and physician judgment based on personal experience is, in my opinion, the worst thing we could be promoting.”  Andrew’s main concern is that my views may amount to “throwing the baby with the bath water.”

On those counts, I must plead guilty as charged.

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The devolution of evidence-based medicine

A chronicle of the demise of clinical judgment

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Anish Koka recently wrote a great piece entitled “In Defense of Small Data” that was published on The Health Care Blog.

While many doctors remain enamored with the promise of Big Data or hold their breath in anticipation of the next mega clinical trial, Koka skillfully puts the vagaries of medical progress in their right perspective.  More often than not, Koka notes, big changes come from astute observations by little guys with small data sets.

In times past, an alert clinician would make advances using her powers of observation, her five senses (as well as the common one) and, most importantly, her clinical judgment.  He would produce a case series of his experiences, and others could try to replicate the findings and judge for themselves.

Today, this is no longer the case.  We live in the era of “evidence-based medicine,” or EBM, which began about fifty years ago.  Reflecting on the scientific standards that the medical field has progressively imposed on itself over the last few decades, I can make out that demands for better scientific methodology have ratcheted up four levels:

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Why I don’t “believe in science”

A response to John Mandrola, with reactions to the SPRINT trial as a case in point

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A few days ago, cardiologist and master blogger John Mandrola wrote a piece that caught my attention. More precisely, it was the title of his blog post that grabbed me: “To Believe in Science Is To Believe in Data Sharing.”

Mandrola wrote about a proposal drafted by the International Committee of Medical Journal Editors (ICMJE) that would require authors of clinical research manuscripts to share patient-level data as a condition for publication. The data would be made available to other researchers who could then perform their own analyses, publish their own papers, etc.

The ICMJE proposal is obviously controversial, raising thorny questions about whether “data” are the kinds of things that can be subject to ownership and, if so, whether there are sufficient ethical or utilitarian grounds to demand that data be “forked over,” so to speak, for others to review and analyze.

Now all of that is of great interest, but I’d like to focus attention on the idea that conditions Mandrola’s endorsement of data sharing. And the question I have is this: Should we believe in science?

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“EBM” on the decline

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In August 2010, a group of eminent statisticians and clinical trial specialists (Drs. Kent, Rothwell, Ioannidis, Altman, and Hayward) published online a proposal to deal with a major short-coming of clinical trials, the so-called heterogeneity of treatment effect (HTE).  The authors offer a refinement in the way clinical trial results are analyzed and reported.

Perhaps sensing mounting dissatisfaction with the blunt tool of ‘evidence-based medicine,’ and perhaps in an attempt to dismiss any further rebuff, Kent et al. introduce their proposal by characterizing the critics of EBM as mere Luddites:

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