The Lancet editorial | "ultra-cutting- and cutting-edge" Theranos and the scientific community

An editorial published Jan. 15, 2022 by The Lancet, noted that an important lesson from the Theranos scandal is that the scientific community needs to better hold tech companies accountable for their claims by reviewing evidence or better pointing out where it is missing. When the scientific community does so, investors, health system managers, and policymakers must listen. While the verdict in this case is personal, another charge is failure to stop her system.

The Story of Theranos is drawing to a close. The company's founder and former CEO, Elizabeth Holmes, was once the world's youngest self-made female billionaire. Last week, this article was published Jan. 15, she was convicted of four of 11 fraud charges related to her actions in the now-defunct blood testing company. Chief Operating Officer Ramesh Balwani will face similar charges in a trial later this year. The booming rise and fall of Theranos has spawned books, documentaries and podcasts. However, despite the widespread concern, the question remains: Where is the scientific community's position in exposing the lack of evidence to support Theranos' claims? Why did the Wall Street Journal expose the scandal and not the so-called self-correcting scientific culture?

In Bad Blood, a documentary report that comprehensively debunks Theranos, John Carreyrou portrays a company working in a scientific vacuum. Theranos has promised to change health care and has tested a large number of patients, but there is no evidence that its products are accurate and safe. There was no thorough explanation of how its technology worked, no repeated studies of its equipment to show its feasibility and effectiveness, no conference presentations, and no scientific exploration of concepts such as overtreatment. Employees are isolated from each other and have a high turnover rate. They describe a culture of fear. At Theranos, several conscientious scientists expressed their concerns, but they were marginalized, fired and forced to sign confidentiality agreements under the threat of lawsuits, allegedly in the name of protecting trade secrets. One of them, Ian Gibbons, committed suicide the day before he was about to testify in court over the company's technology-related lawsuits. The company gives the impression of operating on the basis of recklessness, naivety, flattery and secrecy. The elements of scientific work— public scrutiny, skepticism, rigorous testing, reproducibility, sharing of findings, and peer review— are not reflected in Theranos or its supporters. Holmes committed fraud. But a health tech company is under no obligation to disclose research on its products. This data gap, combined with Theranos' lingering regulatory gray area and investor confirmation biases, creates a blind spot. The result is collective failure.

While blatant fraud by health tech companies may not be common, the lack of scientific evidence for their products doesn't seem unusual. John Ioannidis (and Elftherios Diamandis) was one of the few researchers to raise early questions about Theranos' claims. Subsequently, in 2019, he and his colleagues evaluated the scientific publication literature of healthcare unicorns (startups worth more than $1 billion). Most of these companies have limited or even non-existent engagement and influence in the published scientific literature, they said. This can be a risk for both the business itself and the patient. Whether many companies have done any research is often unknown. Evidence of validity is critical to continued success – and Theranos proves it if evidence is needed – and this scientific evidence must be made public, especially as a prerequisite for procurement and use.

However, such support cannot be unconditional. In the minds of venture capitalists, the main target of change is health care. Investment is booming and there is a growing enthusiasm for new technologies. However, there are different goals involved: healthcare aims at well-being, while startups aim at unfettered growth and short-term gains. In Silicon Valley's "Fake it until you make it" culture, if they don't meet expectations, companies are incentivized to hype their products and overproduce their capabilities. This approach may work in extreme entrepreneurial capitalism, but it is not science. An important lesson from the Theranos scandal is that the scientific community needs to better hold tech companies accountable for their claims by reviewing the evidence or better pointing out where it is missing. When the scientific community does so, investors, health system managers, and policymakers must listen. While the verdict in this case is personal, another charge is failure to stop her system. END

Resources

[1] For the Lancet Commission on diagnostics: transforming access to diagnostics see

https://www.thelancet.com/commissions/diagnostics

[2] For more on automated assays see Articles Lancet Infect Dis 2021; published online Oct 7.

https://doi.org/10.1016/S1473-3099(21)00452-7

[3] For more on metabolomics see Clin Cancer Res 2022; published online Jan 4.

https://doi.org/10.1158/1078-0432.CCR-21-2855

[4] For more on investment in health care technology see

https://www.economist.com/business/how-health-care-is-turning-into-a-consumer-product/21807114

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Chinese translations are for reference only, and all content is based on the original English text.