heranos had a product almost everyone could get behind: a revolutionary blood test that would allow individuals to quickly and easily access information about their health. Startups like Theranos rely on cutting-edge innovation, then leverage that innovation to attract investors. Now the company’s downfall is a signal to innovators, the public, and the media that we need more transparency and credibility built on peer-reviewed publications.
Holmes, who was accused of falsely claiming that Theranos had developed a portable analyzer that could perform virtually any medical test using only a drop of blood, recently settled fraud charges with the Security and Exchange Commission for a penalty of $500,000, among other things.
As Theranos continues on a downward spiral, laying off a majority of its employees, it’s important to take a step back to realize how incredible the company was at galvanizing a movement to help the world see the potential for decentralized health care. Theranos’ vision was to shift health care and testing away from hospitals and medical facilities and into the homes and hands of consumers. The potential of this innovative health care technology let people visualize a world where they could take control of their own health journeys through a simple and accessible tool.
As we know now, the truth about the technology — it didn’t work — caught up to the biotech innovation company.
Each year, the Powering Precision Health Summit brings together top researchers, innovators, physicians, government officials, patient advocates, regulators, and investors to advance the science of precision health. At the last summit, we discussed two key questions: How was Theranos able to mislead the media and public for so long? How did it become the “fake news” of biotech? Our examination of the topic taught us there were many ways in which the industry should have seen this crash coming.
The dearth of peer-reviewed research validating the Theranos technology should have been a huge red flag. While Holmes justified the lack of studies in peer-reviewed journals as a way to closely guard the company’s trade secrets, the public and media should have put more pressure on the company to validate the technology through this trusted process.
Like Theranos, the companies we bring together at Powering Precision Health are on a similar mission: to see indicators of disease in a drop of blood. But where we drastically differ is in the Powering Precision Health network’s discussion of science and fact, in which we rely on research cross-checked by fellow scientists. Concerns regarding disclosure of proprietary information can be addressed by limiting disclosure of such information to third parties who have entered into confidential disclosure agreements, and requiring such parties to allow review of any publications before they are made public. Also, if novel, strong intellectual property strategies of patenting technologies to protect the companies’ interests is advisable.
In the short term, the Theranos saga is a major headache for the many legitimate startups working hard through the proper channels of law and transparency to bring about radical — and real — innovation in health care technology. Coverage of the scandal could create greater headwinds for emerging technologies in health care, as some experts believe startups might now face a greater burden of proof to demonstrate their technology is effective.
In dialogue with the media, all biotech companies should cite third-party support of their findings. (In fact, even peer-reviewed research needs to be closely examined to determine there are no conflicts of interest on the review boards.) Companies’ relationships with the media and the public should be completely open. I have discussed the importance of being able to validate research to the media at Powering Precision Health panels, and the Theranos scandal only reinforces my belief in the need for transparency. The integrity of our research — and the future of health care technology — depend on it.
The topic of science, fact, and trust also drew attention earlier this year at Fortune Brainstorm Health, a conference convening community leaders at the forefront of the 21st-century health care revolution. I listened in on the panel, “In Defense of Science,” where Susan Desmond-Hellmann, Margaret Hamburg, Lloyd Minor, and David Agus identified transparency and open communication as essential components for restoring that trust, including the need to better explain the scientific process so the public doesn’t become suspicious as research evolves.
I agree with their observations. Yet there is a big difference between the evolution of research and truth, and simply lying about your technology or product. In the competitive world of health care startups, it may suit a company’s immediate interests to exaggerate its accomplishments and simplify the narrative to gain favor with media and investors. There’s no question that it’s important to have a long-term vision and lofty goals, but as Theranos so terribly illustrates, only transparency coupled with credible peer-reviewed research will get you anywhere in the long run.
Kevin Hrusovsky is the founder and chair of Powering Precision Health and chairman, CEO, and president of Quanterix, a company that digitizes biomarker analysis.