Health IT, Diagnostics

Theranos: We’ll start publishing our data

Stay tuned for what kind and form that data comes in.

By Chris Seper on October 27, 2015

Theranos will begin publishing data about the company’s diagnostic tests – potentially addressing one of the biggest criticisms of the high-profile, highly valued and intensely scrutinized company.

Company CEO Elizabeth Holmes made the announcement Monday during an on-stage conversation with Cleveland Clinic CEO Dr. Toby Cosgrove at the health system’s Medical Innovation Summit. Among the most severe critiques of Theranos is that it, unlike other life science businesses, has published little data to be reviewed by the medical community.

“I was never against that,” Holmes said. She explained the company thought that data published through FDA decisions would “be more transparent.” But, in response to the criticism, they’ll begin publishing, she said.

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It’s not clear what data will be published or in what form. When asked after her talk to elaborate, Holmes guided me to her public relations team. A spokeswoman said the company would provide an e-mail with more information. A report in The New York Times said Theranos “would publish data comparing its technology to reference testing methods and comparing the results of tests using finger prick samples to those using conventional blood draws.”

Holmes’ appearance at Cleveland Clinic was scheduled well in advance of the furor that erupted after the Wall Street Journal published stories questioning the company’s business practices. Theranos has refuted the story, but criticism and fallout have continued.

Cosgrove, in a roughly 30-minute conversation, mixed effuse praise for Holmes (“we salute you” he said at one point) with questions touching on the recent controversies. Cleveland Clinic has a partnership with Theranos but is not using the technology, Cosgrove said.

The Wall Street Journal story said Theranos hid negative data and clandestinely stopped using its own technology for most of its tests. Holmes addressed the Journal and other press coverage broadly, declaring a large part of it false.

She also refuted a recent report that Walgreens had paused its partnership with Theranos. Walgreens has not said that to her, she said – and said she essentially doubted anything published in the press.

Holmes positioned the limited use of Theranos’ technology as a strategic move in a new era of direct-to-consumer healthcare. Holmes said that she believes if consumers can choose diagnostic tests on their own without recommendations from a doctor – that’s essentially the law Theranos helped get passed in Arizona – then those lab tests needed to be FDA approved.

So, Theranos willingly stopped using its technology until the FDA approves the tests, she said.

This was a precarious moment for Cleveland Clinic, one of the country’s most credible healthcare organizations, which had its CEO on stage with an entrepreneur whose company’s clinical credibility is on the line.

Review of the discussion and of Holmes herself were mixed. Some of the audience treated her like a rock star – taking selfies in a greeting line after her talk. Meanwhile, large swaths withheld applause during moments when others clapped.