Heresy or common sense? Patients, statistics and medical devices

March 24, 2013 – 12:01 PM | By Mark McCarty | No comments yet

There’s no shortage of important developments in the world of medical devices, but today, let’s discuss this matter of dogmatic adherence to biostatistics. We’ve all heard about the FDA advisory committee that recently recommended the agency approve a neurostimulation device for refractory epilepsy, and the concomitant thundering from on biostatistical high about what a corruption of the process it is to put the needs of the few gravely endangered patients ahead of numbers.

What a global tragedy it is when people who are suicidal are given one last option to deal with their disease. What a moral stain on humanity when another advisory committee recommends FDA approve a device to deal with mitral valve regurgitation despite iffy clinical trial outcomes. How dare anyone suggest that people be allowed to get a device (the NeuroPace for epilepsy or the MitraClip for mitral valve regurgitation) when their only alternative is to drop dead or take their own life?

So please, excuse me if I weigh in on behalf of the damned. Pardon me if I meekly beg for some consideration of those whose epilepsy is driving them to suicide, and those whose mitral valve regurgitation leaves them with nothing to look forward to but a slow, tormented path to the grave as their loved ones are forced to watch a death unfold before their eyes. But I feel I must find some way to appease the Authoritarians of Numbers, though they may rain blows of disapproval down upon my slender neck.

Appease, baloney. The fact is that the dominance of the medical discussion by the biostatistician is dead. It’s over, done with, kaput. Deal with it, already.

Clinicians on advisory committee hearings are arguing – and rightly so in my view – for the individual patient and telling biostatisticians that their numerical analyses are all good and well, but when does a biostatistician ever have to decide how to attempt to save a human life? I dare someone with a doctorate in statistics to look a patient in the eye and say, “numbers don’t lie, and that’s too bad for you, even if you are the exception.”

Precisely never. They deal with abstractions, not lives. And although they are perfectly decent human beings with the best intentions, they will never be charged with telling a patient, “well, the device failed the trial, so I’m sorry to tell you, you’re just flat out of luck. Tell God I said hi when you see him!”

So please, enough of the overbearing, obnoxious, totalitarian fulmination regarding biostatistics. Had I wanted to live in a nation-state run by a medical dictator with absolute power, I’d have moved there.

There was a time when we lived in a world in which those with no direct responsibility to the individual patient held sway at advisory hearings. The problem is that we are living in the age of individualized medicine. How soon we forget. In-di-vi-du-al-ized. Capisce? That means if there are patients in there who need a device and will benefit, they should get it.

Some people apparently didn’t get the flyer and would return us to a world dominated by the icy, uncaring gods of biostatistical numerology, and see any deviation from the party line as apostasy. Do I care to live in such a world?

As Fred Flintstone might say, thanks but no thanks.


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