The Theranos evidence, waiting for a story

WFM
WFM – Undercover investigative reporter

Spoiler alert! If you already believe that you can learn more by analyzing failure than by admiring success, you can skip the rest of the post.

Because I decided to apply to medical school late in my junior year at college, in the summer of 1963, I took organic chemistry as a summer school course at Penn. I was also rowing with my life-long friend, Bernie Witholt, in a double scull at Vesper Boat Club. When the chemistry course ended, in order to keep up the rowing I needed a job and a place to live. Those very basic needs drove me to wandering through the labs in the basement of Penn’s medical school, looking for a temporary job as a lab assistant. Dr. Rita Wetton, an academic pediatrician working on hyaline membrane disease, had just said “good-bye” to her two summer assistants, and she hired me on the spot.

The next morning, I showed up in the lab, put on a white coat, and headed down Hamilton Walk to a small gate in the wall that separated the medical school from the vast grounds of the Philadelphia General Hospital. Going through, the PGH autopsy building was on my right, a non-descript squat stone outbuilding. I was there to collect fresh human lung specimens for the lab.

The dieners (autopsy assistants) seemed totally unsurprised that a college kid in a sport shirt with a white coat over it had wandered in to pick up some lungs. (At the time, I didn’t know that Dr. Wetton had a formal research agreement with the PGH pathology department.) I think they knew that they had a critical, if very basic, role in medical education. They asked if I wanted to stay and watch the autopsy that would yield the specimens. I did. So the process of looking objectively for the clues to what went wrong literally started on my very first day at medical school, months before the acceptance letter came.

As I write this, my desk is a mess. For a couple of weeks, I’ve been holding on to interesting material from the media in the hope that if I look at it carefully, objectively, maybe I can understand what happened to Theranos, the lab testing company that just a couple of years ago achieved a “value” of some $9 billion. How did Elizabeth Holmes, a Stanford drop-out with no formal medical credentials, build a corporate house of cards that is now slowly crashing under financial and regulatory scrutiny? David Crow, writing in The Financial Times magazine on April 18th, presented the facts in a very thoroughly researched article. But looking at the facts is like looking at individual organs at an autopsy, after the diener has washed them, weighed them, and put them in clean pans. What we need now is the pathologist to come in, and with knowledge and experience, he or she will tell the story that puts the facts together into a coherent narrative. At some point, the narrative may well make an instructive case study.

For now, here are just a few thoughts. A laboratory, any lab, is an attempt to reduce what information theory calls “noise.” A clinical study is a the concept of a lab built out to work in the real world. The idea of the lab is to eliminate or control variables. These can include changes in temperature, humidity, light, seismic vibration (read Black Hole Blues!), or by using inclusion/exclusion criteria and randomization, differences between groups of patients, whatever is on your list. In any lab work, reproducibility of results and documentation of methods is absolutely critical. Even so, experiments will fail; things will go wrong. That’s often when you learn that a week in the library is worth a month in the lab. It’s a painful lesson.

With her extraordinary intelligence and charm, Elizabeth Holmes seems to have believed that reproducibility and transparent documentation of methods, the fundamental steps common to both laboratory and clinical research, could be finessed. The Greeks gave that error a name; they called it hubris.

Those principles have tripped up John Darsee, William Summerlin, and many others.     But at the Theranos scale, the error has gone beyond the personal. Board members have sustained tarnished credibility, and financial supporters have lost substantial sums. And behind it all is a sad story; they didn’t do their homework. They didn’t ask to see the nuts and bolts,to subject the data to critical peer review.

The Theranos story is far from over, but it holds important lessons for all of us. We should continue to follow it closely.

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