Bye Felicia

I cannot say I am sorry about this one in the least.  I suspect there are more trees in the woods that will make sound as the excessive almost exuberant evaluations over the new”ly” and other apps that are changing the world, or not, eventually crash to the ground when we find they have root rot. Theranos was an enigma, wrapped in a riddle of dead Steve Jobs turtlenecks.


Theranos will close labs and wellness centers, laying off hundreds of employees

By Ariana Eunjung Cha
The Washington Post
October 5 at 9:46 PM

Elizabeth Holmes, the embattled founder and chief executive of Theranos, said late Wednesday that the company will close its clinical labs and wellness centers. The open letter, posted on the company’s website, was essentially an epitaph for the consumer business that was the focus of the once-celebrated Silicon Valley company that Holmes boasted would change the world with its simple and inexpensive pinprick blood test.

In magazine interviews, TV appearances and keynote speeches she gave around the world, Holmes said the innovation would empower consumers by giving them the ability to bypass the gatekeepers — their doctors — to get important information about the health of their own bodies. Numerous investors and consumers fell for her story, and at one point the company was valued at $9 billion, making Holmes the youngest self-made female billionaire ever.

But as the company grew, so did questions about its technology. In a series of skeptical reports starting in October 2015, the Wall Street Journal recounted how even Theranos’s own employees questioned the accuracy of the results of its testing and revealed that government regulators had been looking into the matter.

The company aggressively defended itself against the accusations but over the summer acknowledged major defeats. In June, Walgreens said it had terminated its partnership with the blood testing start-up effective immediately. In July, the Centers for Medicare & Medicaid Services imposed harsh sanctions against Theranos, imposing a fine, revoking its certificate for a lab and banning Holmes from owning, operating or directing a blood-testing lab for at least two years.

The move will affect about 340 employees in Arizona, California and Pennsylvania, and Holmes was generous in recognizing them for sticking by her.

“We are profoundly grateful to these team members, many of whom have devoted years to Theranos and our mission, for their commitment to our company and our guests,” she wrote.

Holmes said the company will now focus its “undivided attention” on the Theranos miniLab platform which she described as a product that would be “miniaturized, automated laboratories capable of small-volume sample testing, with an emphasis on vulnerable patient populations, including oncology, pediatrics, and intensive care.”

The Pitch

Anyone in sales knows what the pitch is. One technique is to throw information at prospects hoping to sell a product or service before the buyer could hang up the phone or slam the door—but good salespeople treat the “pitch” process as a collaborative conversation. I used to when selling cheap shoes, cheap watches as an opportunity to exchange information. I asked what they wanted, what they needed and how could I reconcile those. At times it is like dancing while leading and following as needed. Selling is a craft and art.

I recall a conversation with an Accountant who bought a home remodeling franchise, the rage prior to the 2008 collapse, and he informed that sales persons were low informed ill trained individuals who did not know how to help people. He contradicted himself and in turn demonstrated his ignorance about what it means to “sell” a good, a service, a product or idea. His business is closed. Gosh I wonder why.

I sell myself and ideas everyday to kids. If you think that is an easy target or audience, think again. Or if you have a problem with that you may need a Teacher.

My mother was an amazing Saleswoman and the adage goes she could sell ice to an Eskimo. So perhaps it is in my DNA. But I come from a poor pedigree and have never had the opportunity to attend a high brow school nor have a network of people who wanted to promote, help and in turn push me in a career that could make me rich and famous!!

My mother was Australian and she was well aware of the “tall poppy” syndrome. That if you get too big someone will want to cut you down. That runs deep in my world and that is both a good and a bad thing.

So while the story of this broad Elizabeth Holmes is one I find amusing I know that in the Valley the bullshit of failure is one that is trumped and thumped over every ones head. The story of Steve Jobs lingers as one such example. He’s dead. But hey that doesn’t stop it. I was surprised that as a result of that death that the Valley did not get into more ways to save lives, the other motto they trump as voraciously.

And then came a new black turtleneck, vegan, with the requisite dropout of a highly respected school, the save the world motto and of course the filmed TED talks which hold the oligarchs enthralled in more ways to spend/hide or pretend they give a shit about anything other than their dicks and their wallets.

And of course after the trial and dirt that came out of Ellen Pao’s lawsuit, the Valley (it is a collective like the Borg) wanted to show that they are not patriarchs but equal opportunists when it comes to bogus claims and businesses that will save the world/disrupt or whatever term or phrase they use to mean “make us lots of money.”

So here is a girl with no medical history or background, no actual medical Doctors or Scientists on the letterhead, other than a quote from two Physicians from the Cleveland Clinic, whose role is unclear but hey a Doctor hasn’t met a product or drug they don’t like when a check is attached. Just ask Dr. Ben Carson about that.

I think this will be a great movie. I see Jessica Chastain in the starring role. I just need cash to develop it. Any takers?

The Narrative Frays for Theranos and Elizabeth Holmes

OCT. 29, 2015
The New York Times
By JAMES B. STEWART

Few people, let alone those just 31 years old, have amassed the accolades and riches bestowed on Elizabeth Holmes, founder and chief executive of the blood-testing start-up Theranos.
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This year President Obama named her a United States ambassador for global entrepreneurship. She gave the commencement address at Pepperdine University. She was the youngest person ever to be awarded the Horatio Alger Award in recognition of “remarkable achievements accomplished through honesty, hard work, self-reliance and perseverance over adversity.” She is on the Board of Fellows of Harvard Medical School.

She has been showered with rapturous media attention. Time named her one of the 100 Most Influential People in the World this year. She was the subject of lengthy profiles in The New Yorker and Fortune. Over the last week, she appeared on the cover of T: The New York Times Style Magazine, and Glamour anointed her one of its eight Women of the Year. She has been on “Charlie Rose,” as well as on stage at the Clinton Global Initiative, the World Economic Forum at Davos and the Aspen Ideas Festival, among numerous other conferences.

Theranos, which she started after dropping out of Stanford at age 19, has raised more than $400 million in venture capital and has been valued at $9 billion, which makes Ms. Holmes’s 50 percent stake worth $4.5 billion. Forbes put her on the cover of its Forbes 400 issue, ranking her No. 121 on the list of wealthiest Americans.

Her wealth and fame rest almost entirely on a simple but nonetheless “revolutionary” and “disruptive” technology: Theranos’s ability to run a wide range of lab tests from a tiny sample of blood from a finger prick, in that way eliminating the need for intravenous blood draws. (Ms. Holmes has said that her inspiration was a personal aversion to needles.)

Thanks to an investigative article in The Wall Street Journal this month by John Carreyrou, one of the company’s central claims, and the one most exciting to many investors and doctors, is being called into question. Theranos has acknowledged it was only running a limited number of tests on a microsample of blood using its finger-prick technology. Since then, it said it had stopped using its proprietary methods on all but one relatively simple test for herpes.

Theranos has denied many elements of the Journal article on its website.

For most of its tests, Theranos said that it uses conventional equipment on samples drawn intravenously by needle, which makes its approach pretty much like that of its big competitors, Quest Diagnostics and Laboratory Corporation of America Holdings, whose stocks have gyrated on the start-up’s perceived threat.

This week the Food and Drug Administration released reports based on inspections of Theranos facilities this summer. It concluded that the company’s miniature blood containers — called “nanotainers” — were “unapproved” medical devices for tests beyond herpes.

“While we work with the F.D.A. on clearance of our nanotainer tubes,” said Tilden Katz, a Theranos spokesman, “we have chosen to conduct our tests through venous draws.” He added: “Our proprietary devices are making it possible to run finger-stick samples for tests that could never be run on finger-stick before.”

Amid the controversy, Walgreens said it would not open new Theranos blood testing centers while it sought answers about the company’s technology.

“This isn’t how you introduce technology that claims to be groundbreaking and revolutionary in the health care field,” said Michael Cherny, an analyst at the investment bank Evercore Partners who was an early and vocal skeptic about many of Theranos’s claims.

“Every other person goes through some level of peer review,” Mr. Cherny told me this week. Theranos “decided to shun that approach.”

“In my view,” he said, “that calls into question what’s under the hood of the platform.”

Others raised questions about Theranos and what now appear to have been some pretty bold claims, in some cases long before The Journal’s exposé. Kevin Loria, a reporter on the Business Insider science team, wrote several pointed articles and produced a number of prominent skeptics among clinical pathologists and the broader medical community. The New Yorker and Fortune articles also were skeptical about the lack of peer review for Theranos’s technology. And Eleftherios Diamandis, the head of clinical biochemistry at Mount Sinai Hospital in Toronto, raised numerous issues in a June medical journal article.

“The constant was that nobody had any idea how this works or even if it works,” Mr. Loria told me this week. “People in medicine couldn’t understand why the media and technology worlds were so in thrall to her.”

The attention lavished on Ms. Holmes has been effusive. Her goal of facilitating the early detection and prevention of disease by making blood testing easier and convenient is laudable. And the relatively young company may still work through its current difficulties.
Continue reading the main story
From One F.D.A. Inspection Report:

“You are currently shipping this uncleared medical device in interstate commerce.”

“Complaints involving the possible failure of a device to meet any of its specifications were not reviewed, evaluated and investigated where necessary.”

View the Full Report »

But that so many eminent authorities — from Henry Kissinger, who had served on the company’s board; to prominent investors like the Oracle founder Larry Ellison; to the Cleveland Clinic — appear to have embraced Theranos with minimal scrutiny is a testament to the ageless power of a great story.

“It all fit together perfectly: the college dropout, the fear of needles, the humanitarian mission,” Mr. Cherny said. “She checked all the boxes.”

Indeed, Ms. Holmes seems to have perfectly executed the current Silicon Valley playbook: Drop out of a prestigious college to pursue an entrepreneurial vision; adopt an iconic uniform; embrace an extreme diet; and champion a humanitarian mission, preferably one that can be summed up in one catchy phrase.

Like Bill Gates, Steve Jobs and Mark Zuckerberg, Ms. Holmes dropped out of college. Like Steve Jobs, she wears a uniform of black turtlenecks, suggesting she has loftier things to think about than what to wear. “I probably have 150 of these,” she told Glamour. Like Mr. Jobs, she’s picky about her diet. (She’s a vegan who shuns coffee and drinks green vegetable juices.)

And like Google’s co-founders, Larry Page and Sergey Brin (“Don’t Be Evil”), and Mark Zuckerberg (“Connect the World”), her mission is lofty. As she has repeatedly said, Ms. Holmes envisions “a world in which no one ever has to say goodbye too soon,” brought about through improved health care. Theranos also has a slogan: “One tiny drop changes everything.”

She stays relentlessly on message, as a review of her numerous conference and TV appearances make clear, while at the same time saying little of scientific substance.

The natural human tendency to fit complex facts into a simple, compelling narrative has grown stronger in the digital age of 24/7 news and social media, said Frank Partnoy, professor of law and finance at the University of San Diego, and author of “Wait: The Art and Science of Delay,” which explores the perils of hasty decision-making.

From One F.D.A. Inspection Report:

“These documents were provided as evidence of design validation conducted in 2014; however, they were drafted during this inspection and were not reviewed and approved until 9/10/15.”

“Design validation did not ensure the device conforms to defined user needs and intended uses.”

“We’re deluged with information even as pressure has grown to make snap decisions,” Professor Partnoy said. “People see a TED talk. They hear this amazing story of a 30-something-year-old woman with a wonder procedure. They see the Cleveland Clinic is on board. A switch goes off and they make an instant decision that everything is fine. You see this over and over: Really smart and wealthy people start to believe completely implausible things with 100 percent certainty.”

Ms. Holmes’s story also fits into a broader narrative underway in medicine, in which new health care entrepreneurs are upending ossified hospital practices with the goal of delivering more effective and patient-oriented care.

Two proponents of the approach, Dr. Delos Cosgrove, chief executive of the Cleveland Clinic, and Mark R. Laret, chief executive of the UCSF Medical Center, have enthusiastically endorsed Theranos’s potential to upend conventional medicine.

A Cleveland Clinic spokeswoman, Eileen Sheil, told me that the clinic’s “strategic partnership” with Theranos had not really gotten off the ground and that the clinic had yet to employ any Theranos technology. She said that a statement on the clinic’s website — “Theranos offers a full spectrum of laboratory tests, from the most common panels to highly specialized tests, on blood samples as small as a few drops” — is “their language, not ours, and we can’t verify that.”

Mr. Laret said he had “no information” about Theranos’s technology, but had great respect for Ms. Holmes and the company’s board.

While hot Silicon Valley start-ups like Uber and Airbnb have run into regulatory hurdles, as a medical technology company, Theranos has bumped up against something else: the scientific method, which puts a premium on verification over narrative.

“I don’t know if she’s another Steve Jobs,” said Jerry Yeo, professor of pathology at the University of Chicago and director of the Clinical Chemistry Laboratories there. “You have to subject yourself to peer review. You can’t just go in a stealthy mode and then announce one day that you’ve got technology that’s going to disrupt the world.”

Professor Yeo said that he and his colleagues wanted to see data and testing in independent labs. “We have a small army of people ready and willing to test Theranos’s products if they’d ask us,” he said. “And that can be done without revealing any trade secrets.”

Ms. Holmes said this week that Theranos would disclose data on the reliability and accuracy of its tests. “Data is a powerful thing because it speaks for itself,” she said at a conference at the Cleveland Clinic. “We were never against that.”

Whether that will satisfy Theranos’s growing number of critics will depend on the nature and quality of the data.

“Every other company in this field has gone through peer review,” said Mr. Cherny of Evercore. “Why hold back so much of the platform if your goal is the greater good of humanity?”