by Sofia Reiner
Photo by National Cancer Institute on Unsplash
“Her ambition was voracious and it brooked no interference. If there was collateral damage on her way to riches and fame, so be it” (Carreyrou, 2018). Elizabeth Holmes, the founder of the biotechnological company Theranos, was once worth $4.5 billion but had prioritised gaining wealth, embodied in the erstwhile financial but not functional success of Theranos.
Theranos has had a long-lasting significance, with Holmes on trial for criminal fraud, based on the accusations of the currently bankrupt Theranos defrauding investors, doctors, and patients (U.S. v. Elizabeth Holmes, et al., 2021). This was due to the determined founder encouraging the company to continue despite her unreliable technology, leading the company to secure many partnerships, and negatively affect a large population of patients and medical professionals.
Elizabeth Holmes’ journey towards creating Theranos began while studying chemical engineering. Theranos was built on the idea of creating technology that could perform multiple medical tests on
a single drop of blood, which stemmed from Holmes’ fear of needles. While at Stanford University, Holmes had researched lab-on-a-chip technology and discovered a method for microchip tests on very small amounts of blood (Auletta, 2014). She created a wearable medical device to administer and monitor medication and dropped out to work on her invention full time upon receiving a patent. This motivated her to create Theranos, named from the words “therapy” and “diagnosis” (Auletta, 2014).
Theranos then implemented her technology in the Edison, named after Thomas Edison, and designed to run numerous blood tests with only one drop of blood (Stieg, 2019). The Edison’s purpose was to
conduct immunoassays, a bioanalytical method using antibodies and antigens to measure analytes (chemical
components of a substance) from molecules and macromolecules in solutions (Ju et al, 2017). The antibodies and antigens work as biorecognition agents enabling clinical diagnostics, with the diagnoses being the intended outcome of the Edison’s testing. Furthermore, the process needed for analyte identification was communicated through the internet, as shown in the Theranos patent US7635594 filed in 2016 (figure 1) (Look, 2019).
Theranos offered a “test menu,” showing descriptions and prices, which listed more than 240 tests, allowing an individual to choose specific disorders or imbalances they wanted the Edison to examine (Stieg, 2019).
While Theranos advertised the Edison’s ability to conduct these tests to their sponsors and the general public, the true capabilities of the Edison were much more limited.
The falsified technology of Theranos and Holmes’ unrelenting push to drive its adoption increased the negative impacts on society. The Edison’s goal was largely impossible, and since it required more than Holmes’ accepted volume of blood, the drop of blood given by each participant had to be diluted (Jurkiewicz, 2019). This dilution, along with the varying amounts of lipids and proteins in the blood composition of finger pricks versus blood drawn from veins caused additional analytical mistakes. Most of the employees were unaware of these scientific and foundational problems, and those that knew were fired, leading to the technology’s issues never being addressed (Jurkiewicz, 2019).
To obtain funding Holmes lied to investors by presenting pre-recorded demonstrations and using an outlier detection system to purposely choose the best data points, as the technology was inconsistent and faulty (Khorram, 2021). However, because potential partners did not know about the dysfunctional technology, Theranos machines became incorporated into real life. By 2015, it was estimated that the technology had been used on over 176,000 people (Jurkiewicz, 2019).
Theranos’s mistaken results led to significant harm for their customers and patients. In one case, a woman was misdiagnosed with Hashimoto’s disease, which caused her to make significant lifestyle changes, book excessive appointments, and take unnecessary medications (Alltucker, 2018). Once it was discovered that the technology did not work, company investors lost hundreds of millions of dollars, showing the detrimental effects of the inadequate technology.
The long term impacts of Theranos, as well as the ongoing court case (to which Holmes has pled not guilty), highlights the importance of acting ethically in the technology industry; “Hyping your product to get funding while concealing your true progress and hoping that reality will eventually catch up to the hype continues to be tolerated in the tech industry” (Carreyrou, 2018). Essentially, it is vital to prioritise functioning technology over business success and increased wealth, in order to protect investors, customers, and oneself.
References
Alltucker, K. (2018, July 5). As Theranos drama unwinds, former patients claim inaccurate tests changed their lives. USA Today. Retrieved October 2, 2021, from https://www.usatoday.com/story/news/nation/2018/07/05/theranos-elizabeth-holmes-lawsuits-patients-harm-arizona/742008002/.
Auletta, K., & Denby, D. (2014, December 8). Blood, simpler. The New Yorker. Retrieved October 2, 2021, from https://www.newyorker.com/magazine/2014/12/15/blood-simpler.
Burns, J. (2021, January 18). How many patients were harmed at Theranos? The Dark Intelligence Group. Retrieved October 2, 2021, from https://www.darkintelligencegroup.com/the-dark-report/laboratory-compliance/many-patients-harmed-theranos/.
Carreyrou, J. (2018). Bad blood: Secrets and Lies in a Silicon Valley Startup. Knopf Publishing Group.
Jackson, S. (2021, August 30). Embattled Theranos founder Elizabeth Holmes is about to go on trial for fraud. here's everything you need to know. Business Insider. Retrieved October 2, 2021, from https://www.businessinsider.com/theranos-elizabeth-holmes-fraud-trial-what-you-need-to-know-2021-8.
Ju, H., Lai, G., & Yan, F. (2017). Immunosensing for detection of protein biomarkers. ScienceDirect, 1–30. https://doi.org/10.1016/c2016-0-01168-3
Jurkiewicz, N. (2019). What went wrong with Theranos? Cases and Tools in Biotechnology Management. Retrieved October 2, 2021, from https://ecampusontario.pressbooks.pub/bio16610w18/chapter/what-went-wrong-with-theranos/.
Khorram, Y. (2021, September 16). Theranos whistleblower testifies blood-test machines were about as accurate as a coin toss. CNBC. Retrieved October 2, 2021, from https://www.cnbc.com/2021/09/15/former-theranos-employee-erika-cheung-edison-machines-failed-tests.html.
Look, V. (2019, May 1). Theranos patent for point of care system. The Patent Geek. Retrieved October 2, 2021, from https://thepatentgeek.com/2019/05/01/theranos-patent-for-point-of-care-system/.
McCormick, R. (2016, August 2). Theranos ignores scandal and shows off New Blood-Testing machine. The Verge. Retrieved October 2, 2021, from https://www.theverge.com/2016/8/2/12348766/theranos-minilab-machine-edison-scandal.
Oremus, W. (2021, September 1). Analysis | Elizabeth Holmes's trial spotlights Silicon Valley's thin line between hype and deceit. The Washington Post. Retrieved October 2, 2021, from https://www.washingtonpost.com/technology/2021/09/01/elizabeth-holmes-theranos-trial-analysis-silicon-valley/.
Sheetz, M. (2018, May 4). Secretary Devos, walmart heirs and other investors reportedly lost over $600 million on Theranos. CNBC. Retrieved October 2, 2021, from https://www.cnbc.com/2018/05/04/theranos-devos-other-investors-reportedly-lost-over-600-million.html.
Stieg, C. (2019, March 13). What exactly was the Theranos Edison Machine Supposed to do? What Was Theranos Edison Machine Supposed To Do Anyway? Retrieved October 2, 2021, from https://www.refinery29.com/en-us/2019/03/224904/theranos-edison-machine-blood-test-technology-explained.
Test Menu. Theranos. (2016). Retrieved October 2, 2021, from https://web.archive.org/web/20160622193253/https://www.theranos.com/test-menu.
U.S. v. Elizabeth Holmes, et al.. The United States Department of Justice. (2021, August 25). Retrieved October 2, 2021, from https://www.justice.gov/usao-ndca/us-v-elizabeth-holmes-et-al.
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