Bay Area super-startup Theranos and its CEO Elizabeth Holmes have graced the New Yorker this week, in a piece that describes disruptive, futuristic medicine to the literati set. It also brings up the discrepancy between health and high tech, and how the secrecy that shrouds Theranos – and Holmes – might not be as appropriate in healthcare as it was in, say, Steve Jobs’ case.
The company, founded in 2003 by a then-19-year-old Holmes, is building diagnostic tools to complete standard labwork – like cholesterol or glucose testing – with a single drop of blood. The New Yorker describes the use for this kind of simplification, whihc would likely lower costs in a now-$75 billion diagnostics market:
…several tests can be run—all less expensive than standard blood tests, sometimes as much as ninety per cent below the rates that Medicare sets. A typical lab test for cholesterol can cost fifty dollars or more; the Theranos test at Walgreens costs two dollars and ninety-nine cents.
Much of the New Yorker piece can be gleaned from Holmes’ TEDMED talk this year, told in a “formal instructional cadence,” as the authoer heavily cited the speech through the course of the article. See below:
What the New Yorker adds to the Theranos story is colorful anecdotes like this:
Holmes has an aversion to needles, and her mother and her grandmother fainted at the sight of them and at the sight of blood. Recently, she told me, “I really believe that if we were from a foreign planet and we were sitting here and said, ‘O.K., let’s brainstorm on torture experiments,’ the concept of sticking a needle into someone and sucking blood out slowly, while the person watches, probably qualifies.”
And after rehashing the Theranos origin story, and the advances being made in personalized medicine, the New Yorker gets a bit more nuanced:
A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
But unfiltered medical data aren’t a pure virtue. Last year, the U.S. Food and Drug Administration barred 23andme from disseminating some information out of concern that consumers might misunderstand or misuse it. Some observers are troubled by Theranos’s secrecy; its blood tests may well turn out to be groundbreaking, but the company has published little data in peer-reviewed journals describing how its devices work or attesting to the quality of the results.
“It’s trying to apply the Steve Jobs way of keeping everything secret until the iPhone was released,” Lakshman Ramamurthy, a molecular biologist and a former associate director at the F.D.A., told me. “But a health test is more consequential than a consumer product. It needs to be clinically valid and provide useful information.”
The piece is fascinating. This passage stood out:
When I asked Holmes for evidence that her tests were independently audited, she said that there have been “tens” of audits and “external third-party comparisons” of Theranos’s tests, including those done by the hospital groups that are adopting its finger-prick tests and the pharmaceutical companies that have contracted with Theranos for testing their products. Holmes says that Theranos is certified in forty-eight states, with two more applications pending, under the federal Clinical Laboratory Improvement Amendments of 1988. Under the amendments, laboratories like hers must be certified before they can perform tests for the general public, and their performance is evaluated three times a year by the College of American Pathologists. Holmes also pointed me to a pilot study published by Hematology Reports, an online-only peer-reviewed journal; she is listed as a co-author. The report, released in April, concluded that Theranos tests “correlated highly with values obtained” from standard lab tests.
Read the full article, titled “Blood Simpler: One woman’s drive to upend medical testing,” here.
