Editor ’ s Corner
Recommendations from My Bookshelf : A Bloody Mess
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MAGINE THAT YOU ’ RE young , brilliant , and charismatic , and you have a compelling vision for a bold new idea that could revolutionize health care : scores of laboratory tests , from routine chemistries to tests for lifethreatening infectious diseases , that could be run on just a few drops of blood from a single finger prick .
You even have a great backstory : You have needle phobia and an uncle who died from a cancer that could have been cured if it were just detected early enough by a blood test .
Imagine you are a descendant of the founder of the Fleischmann ’ s Yeast company and of the man who established Cincinnati General Hospital and the University of Cincinnati ’ s medical school . Your family is connected , with ready access to venture capitalists , and you go to a school in Palo Alto , California , which has a recent history of other brilliant , young people who left to start revolutionary tech companies before securing their degrees .
What would you do ? Finish four years of undergraduate work , followed by two to five years of postgraduate studies , and then a residency and fellowship , like those poor saps who eventually become doctors ? Or do you ditch college after two semesters and start to make a difference in patients ’ lives sooner ?
If you ’ re Elizabeth Holmes , the founder and CEO of Theranos , you choose the latter path . John Carreyrou ’ s book Bad Blood : Secrets and Lies in a Silicon Valley Startup takes us through the meteoric rise – and ultimate fall – of Ms . Holmes and her infamous company . It is part cautionary tale and part sociologic study of how many smart , sophisticated , wealthy people let themselves be duped into writing glowing articles about and investing hundreds of millions of dollars in technology that never really worked .
It ’ s a narrative about the power of a good story and an engaging personality .
Ms . Holmes used her family ’ s connections to great advantage , assembling a powerhouse board of directors that included , among others , the famous nonagenarians ( and former U . S . cabinet secretaries ) Henry Kissinger and George Shultz . Mr . Carreyrou intimates that these older gentlemen had a grandfatherly soft spot for Ms . Holmes , which may have clouded their business judgment . A bespoke board and connections beget investment dollars , which led to employee hires and development of a prototype machine . Theranos was dubbed a “ unicorn ” and its valuation quickly topped $ 9 billion .
The technology for analyzing the blood was not much different from available technology – just more compact and claiming to require less blood for the requisite testing .
Much less blood . In fact , such a small amount of blood that it has to be diluted substantially to reach the volume needed for the machine to work . As any scientist will recognize , the more you dilute a substance , the greater the variability in your ability to measure it accurately .
When the machine produced results that , predictably , varied wildly , Ms . Holmes ’ lackeys just threw out the outliers . Their documented results were clustered more tightly , bolstering the machine ’ s reported accuracy . And , when Ms . Holmes feared that the machine wouldn ’ t perform during product demonstrations for potential investors ( including pharmaceutical companies ), she had her programmers alter the machine to display results that looked accurate but had nothing to do with the blood sample being analyzed .
To put it simply , she and her minions lied . Anyone in the company who questioned these methods was fired and forced to sign a nondisclosure agreement on his or her way out the door .
She even convinced Pfizer to validate her faulty prototype machines in patients with cancer who were participating in a clinical trial . Some Theranos employees , who eventually quit , were appalled at the ethical line that had been crossed . As a clinical trialist and as someone with a moral compass , it is hard not to judge this decision with equal opprobrium .
Undeterred , Theranos entered partnerships to start testing blood – both with finger pricks and with traditional phlebotomy samples – in drugstore and supermarket wellness clinics . Tests were run on Theranos ’ machines and
Mikkael A . Sekeres , MD , MS , is director of the Leukemia Program at the Cleveland Clinic in Cleveland , OH .
traditional Siemens machines that the company purchased – and which it used to receive CLIA certification for its lab . Erroneous results from the machine were fed back to physicians and their patients – even to Mr . Carreyrou himself , who had his blood drawn ( via a venous stick ) at a Theranos Wellness Center in a Walgreens . He also had his blood drawn , the same day , at a traditional LabCorp site .
The results ? Theranos reported four lab values as being abnormal , all of which were normal through LabCorp . The downstream implications for the tens of thousands of people who received their laboratory results similarly are obvious : follow-up tests , prescribed medications , and added worry .
Mr . Carreyrou , a reporter for The Wall Street Journal , flexes his investigative journalist muscles jauntily throughout this well-researched and well-referenced book . He interviews and chronicles the experiences of many who participated in the Theranos debacle , which at times bogs down the flow of the book .
The story gains speed at the end , though , as Mr . Carreyrou and the Journal alert Ms . Holmes that they are about to print the story that will unravel Theranos ’ veil of competence . Theranos responds by throwing up legal obstacles and hiring private detectives and company representatives to try to bully sources – and the Journal – into recanting their statements . Nevertheless , Mr . Carreyrou ’ s articles are published in the fall of 2015 and Theranos faces a tsunami of consequent lawsuits , investigation by government agencies , and in March of 2018 , charges from the U . S . Securities and Exchange Commission for conducting “ an elaborate , years-long fraud .” In September 2018 , Theranos announced it is finally folding .
Bad Blood is a cautionary tale about the dangers of hubris , of creating a culture of fear and retribution , and of deceit in meeting the expectations of investors . It also is a reminder of why the press , who have come under frequent attack for being purveyors of so-called “ fake news ,” is so necessary as an independent safeguard against people who lie and cheat for their own gains .
And maybe it ’ s a reminder of why it wasn ’ t such a bad idea for us poor medical saps to complete all of that school and all of that training ; so we could differentiate right from wrong and always keep our focus on what benefits patients .
Mikkael A . Sekeres , MD , MS Editor-in-Chief
10 ASH Clinical News October 2018