Theranos: A Dream Unfulfilled

Written by Alexander Tsioutsias

Edited by Sophia Niño, Hannah Fuchs, and Juliette Draper

Eleanor Roosevelt once mused—“The future belongs to those who believe in the beauty of their dreams.” Unlike no other species, the human race possesses this wonderful capacity to look beyond their immediate desires—whether they be food, water, shelter, or rest. Furthermore, they perceive adversity as a motive for pushing past the proverbial boundary and upsetting the status quo. Historical accounts of technological and scientific progress throughout the ages serve as testimony to our boundless ingenuity and insatiable curiosity. However, I wonder if there are costs associated with realizing our dreams—with transforming far-flung desires into something tactile and real. Must our dreams always be feasible, that is producible within the bounds of a particular study—physics, biology, chemistry? And can we be deceived into thinking that neither costs nor feasibility play any role in working out our dreams?

Perhaps you disagree with the questions laid out before you—that a dream not capable of being realized is not worth pursuing? Maybe you believe that, because the future is uncertain, because we cannot foreknow the costs we may have to face, we should nevertheless try until proven wrong? My role is not to prop up one position or the other, but rather to delineate the consequences of an unhealthy balance between the two. Mind you, human inquiry and investigation are crucial to the advancement of society. For without some desire to explore the unknown, we would, in effect, be perpetually trapped in the dark, continually groping for some way out yet never quite finding it. That being said, we must learn to accept new discoveries with a grain of salt—to stave off credibility until the truth has been revealed.

There is no finer example (in my view) than that of the founder and CEO of Theranos, Elizabeth Holmes. Like many of the great Silicon Valley icons, Holmes dropped out of college to pursue a dream: in her case, to reinvent the practice of extracting and testing blood samples—making it more accessible, convenient, and affordable for individual use. She claimed to have created a compact, groundbreaking machine (the ‘Edison’) that could comprehensively analyze blood test samples using just a single drop of blood from your fingertip. Her machine, if successful, had the potential to upturn a relatively sedentary and complacent medical industry and spur change. However, her dream ultimately flopped. After years of delayed launches and repeated whistleblower reports, the ‘Edison’ which Holmes had been working on could not, as she initially promised, conduct any kind of test accurately, efficiently, or even effectively, and in the process, shareholders lost hundreds of millions of dollars. To this day, it stands as one of the foulest cases of fraud in business history.

From the moment I began researching Holmes and her billion-dollar enterprise, I could not help but consider one question: had it ever occurred to Holmes that she could realistically manufacture a working product? As she began soliciting investments to fund her operation, I wonder if she had known—on some basic level—that what she promised investors was more than some compelling piece of fiction, but rather the promise of a reality to come? You may find my concern out of place; you may believe that Holmes had altruistic motives when starting her company; and you may be convinced that she intended to create a functioning solution but needed more time. This is all very probable. But probability does not imply certainty. Holmes’ dream may very well have been real and well-founded; but, I fail to see how she planned to fulfill the promise she made to herself, to her shareholders, or even to the general public. In much of the research I completed, it seems evident that rather than letting others see that she had no concrete plan for success, she did her utmost to keep it hidden and tucked away, lest they find out.

When Holmes began soliciting investments from venture capitalists, established corporations, and wealthy individuals, she did so by distributing a falsified document. The document supposedly contained the results of trials that pharmaceutical companies, including Pfizer, Schering-Plough, and GlaxoSmithKline, had run to verify the ones Theranos had produced internally. However, the only issue was that none of these companies had ever “approved or agreed with the conclusions in the report."[1] Neither had they permitted Theranos to prominently display their logos on the sponsorship document.[2] Nevertheless, Holmes continued to pass this document around—even swaying then CFO of Walgreens Wade Miquelon to “pay Theranos $140 million as part of a deal to put the startup’s blood-testing devices in dozens of the chain’s drugstores."[3] This had all occurred even when the start-up’s prototype had failed repeatedly to pass even rudimentary blood tests.

Consider this, too: when Adam Rosendorff, the company’s lab director, had resigned and Sunny Balwani—Theranos’ former president and COO—hired his personal dermatologist of fifteen years to replace Rosendorff.[4] Though Dr. Sunil Dhawan met the legal requirements to be a lab director, he had no formal knowledge of pathology, nor had he specialized in it.[5] In a recent testimony Dhawan delivered in court, he admitted that “between November 2014 and the summer of 2015, he spent a total of five to 10 hours doing work for Theranos and went into its Silicon Valley office twice. He had never interacted with patients, physicians or Theranos lab employees."[6] Should someone as important as the lab director not be present at all times to oversee the tests run by Theranos’ machine? Does this not imply that Holmes and Balwani sought to keep results as hidden as possible from the prying eyes of a specialist, or perhaps a few?

What I was most surprised to learn was the level of secrecy to which Holmes and Balwani strived. In one article I came across, I was stunned to realize how fearful the two of them were that someone might uncover their secret. The state of the machine’s progress was so under wraps, even among lab employees, that very few had any knowledge of whether it had been fully operational or not. This had been a deliberate attempt on Holmes’ part to “make teams work in silos so that they could not connect the dots."[7] At times, though, this strategy proved ineffective, and once company employees uncovered the truth, they blew the whistle loudly and forcefully enough for state and federal regulators to begin to take notice.

Take, for instance, Erika Cheung, a former lab associate, who in 2015 reported Theranos’ troubling practices to federal agents. Cheung claimed that the company had blatantly lied about the accuracy of its blood tests and ignored quality control checks to bring the product to market.[8] Despite Holmes’ efforts to refute the assertion, it nevertheless spread doubt—particularly among those who were already very skeptical of Theranos’ claims to fabricate a functioning machine. Much of this had to do with Safeway, who pulled out of a deal it had struck with Theranos to spend $275 million to revamp its supermarkets and accommodate lab testing sites.[9] It also partly had to do with Tyler Schultz, the grandson of George Schultz, a former Secretary of State and board member of Theranos, who was among the first to expose the company’s problems in a report he sent to state regulators in 2014.

In recent testimony Cheung gave at the U.S. v Elizabeth Holmes et al. trial in the United States District Court for the District of Northern California, she depicted how lab associates were instructed to collect data. She stated that because “quality control tests routinely (failed), …the company (had used) an ‘outlier deletion’ system to ‘cherry pick’ the best data points to pass."[10] In essence, Holmes and Balwani had knowingly lied to investors, partners, and consumers about their product's efficacy, and yet they consciously distributed a machine that, although having passed FDA standards, would produce false readings regarding the health of patients.

One thing that still confuses me about Theranos, which I contend partly substantiates my belief that Holmes was unable to produce a working machine, is the fact that from the time she had established her company, recruited hundreds of expert lab technicians, and attracted the support of others in the form of a series of high dollar investments, she had never put forth a single peer-reviewed article that demonstrated her machine’s ability to function as promised. While I understand that it is not particularly common for unicorns—that is, start-up companies valued at more than a billion dollars—to publish research papers—in fact, “more than half of the current unicorns…(have) no highly cited papers”[11]—it seems odd that a company as prominent and well-known as Theranos once was had not done so. Even if the ‘Edison’ could not comprehensively analyze blood test samples, “had (they) contributed its blood-testing technology to studies with other researchers, essential issues could have been detected earlier."[12] This understanding, then, leads me to assume that Holmes could not possibly run hundreds of tests from a single drop of blood and that her desire to keep the data tucked away leads me to speculate that she did not want anyone to uncover the secret she had for so long kept to herself.

It seems to me that the story of Elizabeth Holmes began in earnest with an honest dream, but one that she knew not how to finish. Her limited knowledge of pathology and chemistry surely weighed down on her ability to come up with a product that she could feasibly create. I believe that at some point in time, early in the process, she realized the immense difficulty of doing so yet had deceived herself into thinking that it would somehow be possible. This is where the root of her lie began. And rather than give up all hope when she struggled to deliver on her promise, I think that she convinced herself (and managed to convince others into believing her lie) that she could help create the world’s next greatest invention. I do not mean to sound as if I am all of a sudden ‘flipping sides’ or appearing sympathetic to the situation Holmes currently finds herself in. If this is really how it all went down, I reason that she should face the full force of the law and endure the consequences of her actions, not escape them. We should regard this case of fraud as a vital lesson that we all must learn: never put stock into a single belief, promise, or assurance until we are shown the truth and all the facts. The future, I argue, does belong to those who believe in the beauty of their dreams, but only if they can provide reasons for us to trust them.


 


[1] Erin Griffith & Erin Woo, Key Takeaways from the Sixth Week of the Elizabeth Holmes Trial, N.Y. Tɪᴍᴇs (Oct. 15, 2021), https://www.nytimes.com/2021/10/15/technology/elizabeth-holmes-trial-theranos-takeaways.html.

[2] Id.

[3] Heather Somerville, Former Walgreens CFO Says Theranos Asked for Advance on $100 Million Payment, Wᴀʟʟ Sᴛ. J. (Oct. 13, 2021, 3:46 PM) https://www.wsj.com/livecoverage/elizabeth-holmes-trial-theranos/card/SQP84FPT8nsrzsaTcXbX

[4] Griffith & Woo, supra note 1.

[5] Id.

[6] Id.

[7] Alastair Barlow, First Blood: What Ambitious Businesses Can Learn from Theranos, AᴄᴄᴏᴜɴᴛɪɴɢWEB (Jul. 5, 2019), https://www.accountingweb.co.uk/community/blogs/alastairbarlow/first-blood-what-ambitious-businesses-can-learn-from-theranos.

[8] Yasmin Khorram, Theranos Whistleblower Testifies Blood-Test Machines Were about as Accurate as a Coin Toss, CNBC (Sept. 15, 2021, 7:37 PM), https://www.cnbc.com/2021/09/15/former-theranos-employee-erika-cheung-edison-machines-failed-tests.html.

[9] Griffith & Woo, supra note 1.

[10] Khorram, supra note 7.

[11] Cristea et al, Stealth research: Lack of peer-reviewed evidence from healthcare unicorns, Wɪʟᴇʏ Oɴʟɪɴᴇ Lɪʙʀᴀʀʏ (Jan. 28, 2019), https://doi.org/10.1111/eci.13072.

[12] Id.

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