The Rules Apply to Silicon Valley, Too
By Erin Brodwin / 3 minute read
In recent years, more than a few new companies have entered the health-care sector. Once dominated by hospitals, insurance companies, medical-device makers, and pharmaceutical companies, the medical landscape is increasingly influenced by technology giants, including Facebook, Apple, Alphabet (the parent company of Google), Amazon, and Microsoft, as well as upstarts funded by venture capital.
When editing stories about new health products being developed by Silicon Valley, extend to them the same level of scrutiny as you might to an experimental drug.
Do not mistake innovation for scientific rigor.
Theranos provides one of the most notorious recent examples of the harm that can result when powerful financial interests obscure the risks and efficacy of a health-care product.
As you probably recall, the blood-testing start-up claimed that it would revolutionize health care by doing away with “big bad needles.” It had solid financial backing; investors had placed hundreds of millions of dollars behind the idea of the simple, convenient blood test supposedly in development by the company’s founder, Elizabeth Holmes. News media such as Forbes were quick to slap modifiers like “breakthrough” and “revolutionary” on the company and Holmes. They ran uncritical stories that failed to discuss the advanced technology or the scientific research.
None of these outlets provided any of the key information we’ve described throughout this chapter: not the test’s accuracy; not its potential risks and benefits; not any comparisons to existing blood tests. Before it was revealed that the advanced technology required for Theranos’s concept simply did not exist, Holmes had amassed a net worth of $4.5 billion, and the company had been valued at $9 billion. Eventually, unrelenting reporting by John Carreyrou, of The Wall Street Journal, and others exposed Theranos for the fraud it was.
But while Theranos provides a clear example of how a lack of transparency can accompany colossal failure, even successful products made by technology companies merit extra scrutiny.
Let’s take an example involving Apple. The iPhone maker officially ventured into the health-care realm in 2018 with the creation of the Apple Watch, which allows users to monitor certain aspects of their cardiac health. The device, cleared by the Food and Drug Administration, was an extraordinary achievement: By running several large studies, including one unprecedented, entirely virtual clinical trial, Apple became the first tech giant to sell a consumer gadget with the regulatory clearance necessary to give it truly medical-grade capabilities. But those capabilities still come with important limitations.
For example, while the Apple Watch and embedded electrocardiogram were cleared by the FDA, they were not approved — a key distinction reserved for devices that are considered to be high-risk but have been thoroughly vetted because they provide a clear medical use, such as an implantable pacemaker. Although the FDA cleared the technologies that the company submitted for review, the agency specified two key limitations of the device: first, that it cannot be used to diagnose any heart conditions, and second, that it should not be used as a substitute for clinical care. Not all reporting made these distinctions clear.
In addition, while the clinical trial that the company ran to support the notification component of the Apple Watch was truly unprecedented for its size, design, and scope, it’s important to keep in mind that Apple has the resources and the funding to run a trial of that scope. And despite those clear strengths, the study still came with limitations of its own, including the fact that Apple had funded the study, and the authors of the report included Apple employees.
As should be obvious by now, any reporting should disclose those facts.