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The Theranos story is reaching its conclusion. Elizabeth Holmes, the company's founder and former CEO, once the world's youngest self-made female billionaire, was last week found guilty of four of 11 charges of fraud related to her actions at the now defunct blood testing company. COO Ramesh Balwani will face similar charges in a trial later this year. The sensational rise and fall of Theranos has spawned books, documentaries, and podcasts. Yet, for all the attention, questions remain: where was the scientific community in exposing the absence of evidence backing the claims of Theranos? Why did it take the Wall Street Journal to uncover the scandal, and not the supposedly self-correcting culture of science?

has spawned books, documentaries, and podcasts. Yet, for all the attention, questions remain: where was the scientific community in exposing the absence of evidence backing the claims of Theranos? Why did it take the Wall Street Journal to uncover the scandal, and not the supposedly self-correcting culture of science? In Bad Blood, an exposé of Theranos, John Carreyrou portrays a company working in a scientific vacuum. Theranos promised to transform health care—and it tested huge numbers of patients—yet there was no proof that its products were accurate and safe. No thorough explanation of how its technology worked. No iterative studies of its devices to show viability and effectiveness. No conference presentations. No scientific engagement with concepts such as overtreatment. Employees were kept isolated from each other and staff turnover was high. They describe a culture of fear. Conscientious scientists at Theranos who voiced concerns—and there were several—were marginalised, fired, and made to sign non-disclosure agreements under the threat of litigation, supposedly in the name of protecting trade secrets. One, Ian Gibbons, died by suicide the day before he was due to testify in a lawsuit about the company's technology. The impression is of a company run on recklessness, naivety, sycophancy, and secrecy. The stuff of scientific endeavour—open enquiry, scepticism, rigorous testing, reproducibility, sharing of findings, and peer review—was absent from Theranos and its supporters. Holmes committed fraud. But a health technology company is not obliged to make research on its products publicly available. This data gap, coupled with the regulatory grey areas that Theranos flitted between and the confirmation biases of investors, left a blind spot. The result was a collective failure.

ts supporters. Holmes committed fraud. But a health technology company is not obliged to make research on its products publicly available. This data gap, coupled with the regulatory grey areas that Theranos flitted between and the confirmation biases of investors, left a blind spot. The result was a collective failure. Although outright fraud by health technology companies might be unusual, a lack of scientific evidence for their products seems not to be. John Ioannidis (along with Eleftherios Diamandis) was one of the few researchers to raise early questions about Theranos’ claims. Subsequently, in 2019, he and colleagues assessed scientific publications by health-care unicorns (start-ups with values >US$1 billion). Most of these companies, they said, have limited or non-existent participation and impact in the publicly available scientific literature. This is probably a risk for the businesses themselves, as much as patients. Whether many companies do any research at all is often unknown. Evidence of efficacy is essential for sustained success—Theranos proves it, if proof were needed—and it must be made public, particularly as a prerequisite to procurement and use.

This is probably a risk for the businesses themselves, as much as patients. Whether many companies do any research at all is often unknown. Evidence of efficacy is essential for sustained success—Theranos proves it, if proof were needed—and it must be made public, particularly as a prerequisite to procurement and use. It could be a catastrophe for health if the Theranos case has a stifling effect on legitimate research, investment, and innovation. The Lancet Commission on diagnostics shows that there is a huge unmet need for better access to affordable diagnostic services—almost half of the global population has little to no access to diagnostics, causing serious harms to health. The Commissioners emphasise the transformative potential of innovation, especially in digitalisation, point-of-care testing, and democratisation, to help meet this need. Theranos failed to deliver, yet the requirement remains. Much valuable work is being done in the science of diagnostics: in automated assays, biomarkers, metabolomics, and artificial intelligence. It is vital for global health that support—both intellectual and financial—continues for such efforts.

help meet this need. Theranos failed to deliver, yet the requirement remains. Much valuable work is being done in the science of diagnostics: in automated assays, biomarkers, metabolomics, and artificial intelligence. It is vital for global health that support—both intellectual and financial—continues for such efforts. Such support, however, cannot be unconditional. In the minds of venture capitalists, health care is a prime target for disruption. Investment is booming and there is unbridled enthusiasm for new technologies. But there are disparate aims involved: the goal of health care is wellbeing, the goal for start-ups is untrammelled growth and short-term gain. In the Silicon Valley culture of “fake it until you make it”, companies are incentivised, if not expected, to hype their products and overpromise on capabilities. This approach might work in extreme entrepreneurial capitalism, but it is not science. One crucial lesson of the Theranos scandal is that the scientific community needs to better hold technology companies to account for their claims, either through scrutinising evidence, or better calling out an absence of evidence altogether. When it does so, investors, health systems managers, and policy makers must listen. Although the verdict in this case was against an individual, another guilt lies in the system that failed to stop her.

ount for their claims, either through scrutinising evidence, or better calling out an absence of evidence altogether. When it does so, investors, health systems managers, and policy makers must listen. Although the verdict in this case was against an individual, another guilt lies in the system that failed to stop her. For the Lancet Commission on diagnostics: transforming access to diagnostics see https://www.thelancet.com/commissions/diagnostics 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 For more on metabolomics see Clin Cancer Res 2022; published online Jan 4. https://doi.org/10.1158/1078-0432.CCR-21-2855 For more on investment in health care technology see https://www.economist.com/business/how-health-care-is-turning-into-a-consumer-product/21807114 For the Lancet Commission on diagnostics: transforming access to diagnostics see https://www.thelancet.com/commissions/diagnostics 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 For more on metabolomics see Clin Cancer Res 2022; published online Jan 4. https://doi.org/10.1158/1078-0432.CCR-21-2855 For more on investment in health care technology see https://www.economist.com/business/how-health-care-is-turning-into-a-consumer-product/21807114 © 2022 Kimberly White/Getty Images2022