Theranos must release data to regain trust of scientists and public
Blood testing startup, Theranos, must release detailed and transparent data proving that its 'revolutionary' diagnostics services work as-advertised, according to this Wired opinion piece. Arguing that Theranos' detailed rebuttal of the two Wall Street Journal pieces that attacked the veracity and accuracy of the tests was insufficient, Nick Stockton calls for the company to share its primary data with the public, to quell the many sceptics in the scientific community. 

Last week, one of America's most prestigious newspapers published a pair of blistering critiques of the country's hottest biomedical startup. The Wall Street Journal alleged that the blood diagnostics company Theranos wasn't operating at nearly the level of technological innovation its hype (and $9 billion valuation) had led the world to believe.

After a week of objections across various media platforms, Theranos today released a document offering a bullet-pointed rebuttal of the Journal's allegations (not to mention plenty of broadsides at the paper's ethics and credibility). But the one thing the 6,000 word rebuttal does not do—and the one thing it really needed to—is provide data.

I reached out to Theranos, asking them if they'll be releasing their primary data. Their response: "All of the information we have released at this time is available online; if we release more, we will be sure to let you know." Since I'm not holding my breath anymore, let's talk about data.

Data, data, data. If you've been following Theranos long enough, you'll recognize this refrain: a call for transparency so the medical community can verify that Theranos' technology does what the company claims. When Theranos deigns to respond, it usually says something along the lines of "We have data! We've shown it to the FDA! We post it on our website!"

All technically true, but the FDA data shown in that paper are aggregate results, not primary. What does primary data look like? What does it do? How would you know it when you saw it?

We'll get into that, I promise, but first let's review what Theranos is. The company is aiming to offer more than 200 blood tests at prices less than half the Medicare reimbursement rate. Further, rnse tests would be available without a doctor's prescription. And best of all, many tests would be available via a relatively painless fingerstick instead of a significant blood draw. "When I first heard about Theranos I thought, 'This is fantastic! How great would it be if everything could be done by fingerstick,'" says Steve Master, director of clinical chemistry at Weill Cornell Medical College.

The Journal's article said, in essence, that those fingerstick tests did not work as advertised.

Not surprisingly, Theranos disagrees. And if you read the company's release detailing all the reasons why, you will probably get confused. It is very long, and very detailed, and deals in the nuances of things like regulatory approval, the testing of tests, why certain tests get tested some ways while other tests get tested in other ways, and why Theranos' tests are special and therefore get tested in a way that the Journal just didn't take the time to understand. The document is nothing if not thorough in addressing every allegation brought forth by the Wall Street Journal.

But Theranos does not offer any hard evidence. Despite all the dense regulatory nuance, the release is pretty much a rhetorical combo move. It has none of the data that would make it a proper scientific rebuttal.