Theranos

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Tweeted by @kalltucker

"Do you really trust yourself to understand lab results?"
http://www.azcentral.com/story/opinion/op-ed/2015/07/07/arizona-lab-tests-understand/29834539/

Let me offer an example of who this could be detrimental to a patient's health: testing for food allergies, for which there are a number of nuances best understood with the appropriate training.

This seems to be a pretty hot topic among docs. 

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"Bah Humbug—Cranky Year-End Allergy News Round-Up"
http://asthmaallergieschildren.com/2014/12/18/bah-humbug-cranky-year-end-allergy-news-round-up/

Dr. Keet comments, "As an epidemiologist who studies allergies and an allergist, I have to wholeheartedly disagree with this statement, and the problems with this statement have profound implications for the overall business model of Theranos."

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"JAMA Questions Stealth Science"
http://www.qmed.com/news/jama-questions-stealth-science

Although Theranos claims it has reinvented lab testing, making it possible to run hundreds of diagnostic tests using a single drop of blood, the article in the Journal of the American Medical Association (JAMA) points out the lack of peer-reviewed studies related to its technology.

What about overdiagnosis, false-positives, or the possibility of an uptick in iatrogenic causes?

Titled "Stealth Research: Is Biomedical Innovation Happening Outside the Peer-Reviewed Literature?" the article by John P.A. Ioannidis, MD

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Tweeted by @lucienengelen


"Theranos and Capital BlueCross Team Up to Provide Innovative, Low Cost, Accessible Lab Testing Services in Central Pennsylvania"

https://theranos.com/news/posts/theranos-and-capital-bluecross-team-up-to-provide-innovative-low-cost-accessible-lab-testing-services-in-central-pennsylvania

Theranos, which received clearance of its lab technology from the FDA last week, is the first lab to publish all of its pricing

As it develops new testing services, the company has committed to submit all of its laboratory-developed tests to FDA for review and approval, and is the only lab to publish and update test proficiency data and customer satisfaction metrics on its website.

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Nice article showing how tests in general can be hard to interpret ...


"Oversold prenatal tests spur some to choose abortions"
http://www.bostonglobe.com/metro/2014/12/14/oversold-and-unregulated-flawed-prenatal-tests-leading-abortions-healthy-fetuses/aKFAOCP5N0Kr8S1HirL7EN/story.html

a distraught Chapman said she wanted to terminate the pregnancy immediately

What she — and the doctor — did not understand, Chapman's medical records indicate, was that there was a good chance her screening result was wrong. There is, it turns out, a huge and crucial difference between a test that can detect a potential problem and one reliable enough to diagnose a life-threatening condition for certain.

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Tweeted by @eliza68


"Burst bubbles
Two medical-technology companies illustrate the ups and downs of innovation."
http://www.nature.com/news/burst-bubbles-1.18646?WT.mc_id=TWT_NatureNews

Theranos and 23andMe are two medical-technology companies with their origins in Silicon Valley.

Their stories may seem similar. But the differences offer an important lesson for would-be health disruptors: this industry can change, just not as quickly as entrepreneurs and their investors might hope, and only if those offering the change can also offer data to back up their claims.

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"The Theranos Scandal Could Become a Legal Nightmare"
http://www.wired.com/2015/10/theranos-scandal-could-become-a-legal-nightmare/?mbid=social_twitter

You can always sue. "The question is whether you can win," says Hank Greely, a lawyer at Stanford Law School who specializes in biology and medicine. "They'd have to show that the Journal acted recklessly or with malice." In other words, they don't just have to prove that the newspaper is wrong, they have to prove that the newspaper knew it was wrong.

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"Discussion of the Theranos Controversy with Elizabeth Matsui"
http://simplystatistics.org/?p=4391

I talked with Elizabeth Matsui, a Professor of Pediatrics in the Division of Allergy and Immunology here at Johns Hopkins, to discuss Theranos, the realities of diagnostic testing, and the unique challenges that a health-tech startup faces with respect to doing good science and building products people want to buy.

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Blood, Simpler
One woman's drive to upend medical testing.

http://www.newyorker.com/magazine/2014/12/15/blood-simpler

Investors have valued the company at more than nine billion dollars, comparable to the two major diagnostic labs. Holmes owns more than fifty per cent of the company; she was profiled last spring in Fortune and subsequently featured in Forbes as "the youngest self-made female billionaire in the world."

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Tweeted by @SusannahFox

@dennisjboyle In my dream scenario, @theranos has been stealthily listening to patients' and caregivers' wishes and hopes.

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"Theranos to begin offering blood work services in Pennsylvania"
http://www.usatoday.com/story/tech/2015/07/08/theranos-to-begin-offering-blood-work-services-in-pennsylvania/29889815/

Theranos' ultimate goal is to open labs within five miles of every American via Walgreens' network of 8,200 stores.

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"Elizabeth Holmes' 'revolutionary' blood tests are coming to the East Coast

http://www.businessinsider.com/theranos-partners-with-capital-bluecross-insurance-company-2015-7

Lawrence notes that this deal could serve as a precedent for other Blue Cross and Blue Shield insurance companies, which serve more than 100 million people.

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"An Inside Look At The Theranos Direct-To-Consumer Experience"
http://www.forbes.com/sites/danmunro/2015/07/13/an-inside-look-at-the-theranos-direct-to-consumer-experience/

The one test I took certainly lived up to any retail expectation I had and was frictionless, pain-free and low-cost. It also includes a new consumer experience that's been a long time coming ‒ and in some health circles ‒ equally controversial. Direct access to my own clinical data.

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"Why I Believe My Theranos Blood Test Was Inaccurate And Useless"
https://medium.com/@danmunro/why-i-believe-my-theranos-blood-test-was-inaccurate-and-useless-7854ed96f4ef#.9x35kn6hr

I do have a very nicely designed PDF — that was delivered securely — with some numbers from the test I took in July. It may be suitable for legal discovery in a court action, but I have zero confidence in any of the numbers relative to the blood test I paid for. It's easy to see why consumers feel betrayed by this company. I'm one of them.

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"Theranos phenomenon: promises and fallacies"
http://www.degruyter.com/view/j/cclm.2015.53.issue-7/cclm-2015-0356/cclm-2015-0356.xml

Theranos, promises to revolutionize diagnostics by offering multi-analyte testing at low prices in commercial outlets, thus challenging the current paradigm of targeted and centralized diagnostic testing

most of the company's claims are exaggerated

I also draw attention of associated issues, such as self-testing and self-interpretation of results, over-testing, over-diagnosis and over-treatment, along with their associated harms.

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Tweeted by @hmkyale

"Running A Few Tests On Theranos: Can Elizabeth Holmes Revolutionize Diagnostics?"
http://www.forbes.com/sites/matthewherper/2015/07/15/giving-theranos-a-few-tests/

"Someone in need comes to you and, because they don't have the right kind of insurance that can allow the price of these lab tests to be low, you charge them thousands of dollars for a lab test? There's something wrong with that. We believe very strongly that these tests need to be affordable, and they need to be operator consistent, with transparent prices, and that needs to happen in a way that an average person can afford them."

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"Fixing The Laws That Let Theranos Hide Data Won't Be Easy"
http://www.wired.com/2015/10/fixing-the-laws-that-let-theranos-hide-data-wont-be-easy/

But Theranos isn't required to show its data to anyone except the occasional government inspector, because it is regulated by a special set of rules that effectively let clinical labs police their own tests. Called the Clinical Laboratory Improvement Amendments, these regulations were meant to strike a balance between in-lab innovation and government-sanctioned safety.

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"The Secret Culprit in the Theranos Mess"
http://www.vanityfair.com/news/2016/05/theranos-silicon-valley-media

The Centers for Medicare and Medicaid Services found serious deficiencies in the company's Newark, California, lab. Theranos is under federal investigation by the S.E.C. and U.S. Attorney's Office. Regulators have proposed banning Holmes from her company for two years.

Outlets that write negatively about gadgets often don't get pre-release versions of the next gadget. Writers who ask probing questions may not get to interview the C.E.O. next time he or she is doing the rounds. If you comply with these rules, you're rewarded with page views and praise in the tech blogosphere.

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"Theranos Is Wrong: We Don't Need More Blood Tests"
http://fivethirtyeight.com/features/theranos-is-wrong-we-dont-need-more-blood-tests/?ex_cid=story-twitter

Much of the debate over the last few months has been about whether Theranos's technology can actually do what the company has said it can. But there's a dubious assumption at the heart of Theranos, arguably just as damning as the questions about its technology. Theranos wants us to believe that ostensibly healthy people can get healthier by having more tests. But the science suggests that is far from true.

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Frequent Lab Testing Isn't Very Useful
Healthcare Triage
https://m.youtube.com/watch?v=bW_V7EZNW84

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"The Rise and Fall of Theranos: A Cartoon History"
By Mark Fiore and Jon Brooks
JULY 14, 2016
http://ww2.kqed.org/futureofyou/2016/07/14/the-rise-and-fall-of-theranos-a-cartoon-history/