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The Science of Elizabeth Holmes' Theranos: Is It Legit?


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Long article worth reading if this piques your interest:

Theranos, a company founded by Stanford sophomore Elizabeth Holmes in the fall of 2003 (she dropped out a few months later) has generated a lot of buzz for developing a revolutionary approach to the blood test. Theranos' innovation theoretically does clinical lab testing faster, cheaper, and, in some ways, better. Because of that, Theranos could upend the branch of medicine that provides the data used in roughly 70% of medical decisions.

That disruptive potential has already made Theranos famous and Holmes the youngest female billionaire in the US. But the more buzz Theranos gets, the more questions people seem to have.

When Holmes landed on the Forbes billionaire list in 2014, Theranos had raised $400 million, and the company had a valuation of $9 billion. Holmes owns about half of Theranos, with her worth estimated at more than $4.5 billion.

Holmes assembled a board of directors for Theranos that last year was described by Fortune magazineas "what may be, in terms of public service, the most illustrious board in U.S. corporate history." Among those board members are a retired Navy admiral, a retired Marine Corps general, former US Sens. Sam Nunn and Bill Frist, former CDC director William Foege, former Wells Fargo CEO Dick Kovacevich, and two former secretaries of state, George Shultz and Henry Kissinger.

The caliber of the board suggests that Theranos must have developed a transformative innovation, but other than Frist, who has not practiced medicine in many years, only Foege is a medical professional. The technical details about Theranos' seemingly revolutionary tests are hard to come by, and the company is known for its secrecy about its founder's invention.

There's one fundamental question, one that in some ways is unanswerable without revealing information that Theranos wants to keep confidential: How, exactly, does what Holmes invented work?

"It's impossible to comment on how good this is going to be — it may be wonderful and it may bomb, but I really can't be more definitive because there's nothing to really look at, to read, to react to," says Dr. David Koch, president of the American Association for Clinical Chemistry and a professor at Emory University.

We know enough to say that there is something promising about Theranos. People who have seen the company's data are convinced of that. Holmes has teamed up with Walgreens to put Theranos labs inside its pharmacies (Theranos is in 41 of more than 8,000 Walgreens so far); Theranos has been conducting tests for GlaxoSmithKline and Pfizer and several hospital systems; it recently set up a partnership with Cleveland Clinic; and it earns revenue from the work it does for the US military, though Holmes has previously declined to elaborate on that, beyond saying that it's an important area with the potential to save lives. Each lab is certified, and it can operate officially in a clinical capacity.

But Theranos hasn't published peer-reviewed studies comparing its tests to traditional ones, and the company hasn't allowed independent experts to publicly assess its labs, citing the need to protect its intellectual property.

The lack of peer-reviewed studies, the sort of evidence that scientists traditionally rely upon when looking at a development in their field, has generated skepticism from experts.

"They completely bypassed the traditional process of peer review or publishing in peer-reviewed journals or having peer labs evaluate their product," says Dr. Jerry Yeo, a professor and director of Clinical Chemistry Laboratories at the University of Chicago.

Yeo says it's normal for companies when they launch a new medical product to publish their results and allow experts to analyze their tests, especially as they become major players in the field.

"Why haven't they shown us that information, why haven't they been willing to publish it, and why haven't they shown comparisons with existing technology?" Yeo says.

Theranos says it wants to protect the details of its unique product from its competitors, just as any company would protect an innovation. It also says it wants the Food and Drug Administration to evaluate its product to show that it works.

A representative for Theranos provided this statement to Business Insider:

The FDA, which is the ultimate arbiter of safety and efficacy — of high quality tests that are proven to work — is the gold standard, and Theranos wants its tests to be the best and safest for its patients. We have called for an unprecedented level of review with the FDA, something we are not obligated to do. We've been submitting all of our tests to them and are committed to continuing to do so.

Business Insider wanted to see what we could figure out about the science behind Theranos, even though it's impossible to say definitively what the company's technology is or how well it works without published data. However, we can study what Holmes has said about Theranos and look at the latest developments in related scientific fields. We spoke to experts in the fields of clinical pathology and laboratory medicine, biomedical engineering, and healthcare investing, all to see if Theranos really could have an approach to blood testing that's faster, cheaper, and better.

This investigation raised as many new questions as answers:

http://businessinsider.com/science-of-elizabeth-holmes-theranos-2015-4

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