TTA’s Week: CVS-Aetna,, Cerner-Lumeris, NHS news roundup, and is telemedicine really a bust?

 

 

CVS-Aetna looks likely, FCC likes telehealth, Cerner takes a bite of value-based health, and is telemedicine really a bust–or are we not thinking right? 

News roundup: FCC RPM/telehealth push, NHS EHR coding breach, unstructured data in geriatric diagnosis, Cerner-Lumeris, NHS funds social care, hospital RFID uses 
A mHealth refutation of ‘Why Telemedicine is a Bust’ (Mobiles will conquer all)
Department of Justice won’t challenge CVS-Aetna merger: report (Finally, a healthcare mega-merger that goes through)

The ‘record-breaking first half’ in funding that wasn’t. More ‘Bad Blood’. And GP at Hand’s disruption may be a good thing for UK’s GP practices, according to the RCGP chair. 

RCGP chair at The King’s Fund: destroy Babylon Health’s GP at Hand ‘amazing model’, the present financial model–or both (A whole lot of disrupting going on)
The Theranos Story, ch. 52: How Elizabeth Holmes became ‘healthcare’s most reviled’–HISTalk’s review of ‘Bad Blood’ (A Must Read)
Rock Health’s ‘Another record-breaking first half’ in digital health funding is actually–flat. (With a Soapbox Extra!) (Don’t believe the spin, dig in)

Still wondering how Atul Gawande will continue medical practice and be a CEO? Will Google be the ‘Medical Brain’ powering hospitals and clinicians? News from early stage to mature companies. 

News roundup: Paradromics; Cerner’s trials with DOD, VA; Medtronic; Babylon Health; NHS’ private data
Google’s ‘Medical Brain’ tests clinical speech recognition, patient outcome prediction, death risk (Billions of data points to a lot of outcomes)
Some more views on (and by) Atul Gawande on the JP Morgan-Berkshire-Amazon health combine (Not what you think)

The pick of a noted healthcare innovator and theoretician to head the JP Morgan Chase-Berkshire Hathaway-Amazon health leviathan induces skepticism. Theranos is back–in the courts, and its principals are facing prison time. 

The 50,000 foot pick as CEO of the JP Morgan Chase-Berkshire Hathaway-Amazon health joint venture (A great theoretician and gadfly, but not a herder of a million cats)
Instant GP, don’t even add water; Babylon Health taps into the corporate market via insurer Bupa (UK) (A budding revolution from the payer side?)
The Theranos Story, ch. 51: how Holmes wasn’t Steve Jobs despite the turtlenecks–a compare and contrast (Aping Steve Jobs won’t make you successful. But it will get you press!)
The Theranos Story, ch. 50: DOJ indicts Holmes, Balwani for fraud (updated) (What you need to know right here)

 

Following up with ‘old friends’: Babylon’s Big Deal with Samsung, VA’s Home Telehealth awards. An analysis of analogue versus digital telecare. And Theranos’ Holmes is ‘The Woman Who Came to Dinner’ and won’t leave.

Rounding up the news: Babylon’s Samsung Health UK deal, smartphone urine test debuts, a VA Home Telehealth ‘announcement’, Aging 2.0’s NY Happy Hour (Babylon’s big chance, VA HT’s worst kept secret revealed, Salford Royal trials Healthy.io)
CMS urged to further reimburse telehealth remote patient monitoring with three new CPT codes (How codes can change the profit picture of health tech)
The Theranos Story, ch. 49: CEO Holmes reportedly raising funds for a new company–and feeling like Joan of Arc (John Carreyrou’s Theranos book is just out; Elizabeth Holmes isn’t Monty Woolley and not St. Joan either)
OnePerspective: Analogue telecare is a dead horse: stop flogging it (And go digital–the perspective from the CEO of Communicare247)


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The Theranos Story, ch. 52: How Elizabeth Holmes became ‘healthcare’s most reviled’–HISTalk’s review of ‘Bad Blood’

click to enlargeA Must Read, even if you don’t have time for the book. During the brief Independence Day holiday, this Editor caught up with HISTalk’s review of John Carreyrou’s ‘Bad Blood’, his evisceration of the Fraud That Was Theranos and The Utter Fraud That Is Elizabeth Holmes. Even if you’ve read the book, it’s both a lively recounting of how the scam developed and the willingness–nay, eagerness!–of supposedly savvy people and companies to be duped. The reviewer also reveals that Mr. Carreyrou wasn’t the first to raise questions about Theranos after raves in the press and kudos from the prestigious likes of Eric Topol. Mr. Carreyrou’s first article was in October 2015 [TTA 16 Oct 15] whereas Kevin Loria wrote the first exposé in Business Insider on 25 April 15 which raised all the fundamental questions which Theranos spun, hyped, or otherwise ignored–and Mr. Carreyrou eventually answered. (Our blow by blow, from him and other sources, is here.)

The review also picks out from the book the scabrous bits of Ms. Holmes’ delusions; her makeover to become the blond Aryan female Steve Jobs mit Margaret Keane-ish waif eyes–something she took far too literally; the affair between her and Sunny Balwani, certainly in violation of the usual ethics–and her Hitler in the Bunker, April ’45 behavior as Theranos collapsed around her. 

The review concludes by telling the healthcare community something we need said plainly, often, and written in 50-foot letters:

Theranos is a good reminder to healthcare dabblers. Your customer is the patient, not your investors or partners. You can’t just throw product at the wall and see what sticks when your technology is used to diagnose, treat, or manage disease. Your inevitable mistakes could kill someone. Your startup hubris isn’t welcome here and it will be recalled with great glee when you slink away with tail between legs. Have your self-proclaimed innovation and disruption reviewed by someone who knows what they’re talking about before trotting out your hockey-stick growth chart. And investors, company board members, and government officials, you might be the only thing standing between a patient in need and glitzy, profitable technology that might kill them even as a high-powered founder and an army of lawyers try to make you look the other way.

In other words, what you (the innovator, the investor) is holding is not a patient’s watch, it could be his heart, lungs, or pancreas. (Musical interlude: ‘Be Careful, It’s My Heart’)

The Theranos Effect is real in terms of investment in small companies out there on the ‘bleeding edge’. The cooling is mostly salutory, and we’ve been seeing it since late last year (see here). But…will we remember after it wears off, after the fines are collected, the prison time is served?

The Theranos Story, ch. 50: DOJ indicts Holmes, Balwani for fraud (updated)

click to enlargeThe other shoe drops into this bottomless well. If Elizabeth Holmes and Sunny Balwani thought that the March SEC action [TTA 15 Mar] would be it, they were misinformed. Today, the Department of Justice, US Attorney’s Office for the Northern District of California, charged them with two counts of conspiracy to commit wire fraud and nine counts of wire fraud. According to CNBC, they were arraigned in US District Court in San Jose Friday morning. Both were released on $500,000 bond each and ordered to surrender their passports. Holmes’ parents appeared with her in court.

If found guilty, both Ms. Holmes and Mr. Balwani face up to 20 years in prison, plus $250,000 in fines and clawing back of investor funds. 

“Wire fraud” in US law is fraud that is enabled and takes place over phone lines or involves electronic communications. By appearing online, making phone calls, emailing materials such as marketing materials, statements to the media, financial statements, models, and other information, Ms. Holmes and Mr. Balwani defrauded potential investors. Patients and doctors were defrauded by ads and other types of solicitations to use Theranos’ blood testing services at Walgreens, despite the fact that they knew the test results were unreliable.

Both Ms. Holmes and Mr. Balwani will have plenty of time to explain their sincere belief that their test devices and methods would be validated with time…but they had to, in Silicon Valley parlance, fake it till they made it. Indictments of this type take about two years to conclude, especially if they are big (as a formerly $9 bn valued company is) and tangled. Ms. Holmes will undoubtedly release statements on how she is being martyred like Saint Joan, how this doesn’t happen to men in Silicon Valley, and that they are allowed to fail but she can’t. Perhaps she was under the spell of the 19 years-her-senior Svengali Balwani. (Minus the Jobsian black turtlenecks, one anticipates her next choice of wardrobe. Sackcloth tied with a rope? Chain mail?)

Expect the doors to shut soon. Fortress Investment Group, which loaned Theranos $65 million (of a reported $100 million) in December 2017, was reportedly coming for the assets (as they are wont to do) by the end of July, according to the Wall Street Journal and other sources. 

Ms. Holmes is–finally–removed as CEO. Theranos announced that David Taylor, the company’s general counsel, has been appointed CEO as well as general counsel, while Ms. Holmes will remain as founder and board chair. None of this is reflected on their website. In fact, Mr. Taylor is nowhere to be found on the website’s leadership page. 

The estimable John Carreyrou, who broke the story in the WSJ and is the author of Bad Blood [TTA 13 June], on The Street’s Technically Speaking podcast at 06:00 shared this insight on how Theranos got away with bad tests. While both FDA and CMS highly regulate lab testing and the machines that perform them, neither actively police “lab-developed tests, which refer to tests fashioned with their own methods and devices” for blood testing. Basically, according to Mr. Carreyrou, Holmes and Balwani, our Bonnie and Clyde, “drove a truck right thru that loophole and took advantage of it.” Far beyond B&C, $1 bn of investors’ money is the Federal Reserve of banks.

On the indictment: WSJ, CNBC. The Northern District release on the indictment is here. Another essay by Mr. Carreyrou published 18 May is available to those who can get past the paywall. Hat tip to Bill Oravecz of WTO Consultants.

Updated: For additional coverage of what’s next in the legal vein for Holmes and Balwani, see the NY Times on potential defense strategies for the duo, including that they truly believed what they were saying to investors was true and they were bamboozled like everyone else, ‘materiality’–that investors didn’t use the statements as a basis for investing, and ‘prove it’. Will they take a plea deal? Stay tuned. 

The Theranos Story, ch. 49: CEO Holmes reportedly raising funds for a new company–and feeling like Joan of Arc

click to enlargeHere’s the place where your money will go if you’re an investor. John Carreyrou has now compiled his reporting for the Wall Street Journal on Theranos into a new book, Bad Blood: Secrets and Lies in a Silicon Valley Startup, and it is a Must Read for this Editor and anyone interested in the nexus of Tech, Healthcare, and Hype. (The link goes to AbeBooks, a worthy marketplace for independent booksellers.)

According to Mr. Carreyrou, the founder/CEO Miss Elizabeth Holmes–still leading the company despite settling with the SEC on fraud charges, surrendering her voting control, barred from serving as a public company director or officer for 10 years, and still fighting civil lawsuits–is raising fresh funds for a new venture.

Your eyes did not fool you.

Theranos was a Dogpile of Deceit. From hacking standard Siemens blood testing machines to work with tiny samples, falsifying test results, faking up the Edison test machine, to company financials, it was one lie on the other, chronicled for our Readers in nearly 50 chapters and multiple references. 

Mr. Carreyrou was asked by former Timesman and Vanity Fair reporter Nick Bilton whether, in this unmistakable pattern, Ms. Holmes was a sociopath. Mr. Carreyrou wisely refrained from diagnosis based on a used DSM-V, being a reporter and not her psychiatrist. From Mr. Bilton’s interview podcasted on ‘Inside the Hive’:

“At the end of my book, I say that a sociopath is described as someone with no conscience. I think she absolutely has sociopathic tendencies. One of those tendencies is pathological lying. I believe this is a woman who started telling small lies soon after she dropped out of Stanford, when she founded her company, and the lies became bigger and bigger,” Carreyrou said. “I think she’s someone that got used to telling lies so often, and the lies got so much bigger, that eventually the line between the lies and reality blurred for her.”

Mr. Carreyrou, and by inference anyone who doubted her, like her CFO, and especially those who went public with criticism–well, we are the Bad Guys:

“She has shown zero sign of feeling bad, or expressing sorrow, or admitting wrongdoing, or saying sorry to the patients whose lives she endangered,” he said. He explained that in her mind, according to numerous former Theranos employees he has spoken to, Holmes believes that her entourage of employees led her astray and that the bad guy is actually John Carreyrou. “One person in particular, who left the company recently, says that she has a deeply engrained sense of martyrdom. She sees herself as sort of a Joan of Arc who is being persecuted,” he said.

Mr. Carreyrou was set upon by this ‘martyr’s’ legal pitbulls, one David Boies, until he wisely exited stage left with a bushelful of worthless stock [TTA 21 Nov 16].

(And what is it about Stanford University that fosters people like Ron Gutman, recently ousted from HealthTap over employee abuse and intimidation charges in what may be a Silicon Valley First? [TTA 3 May] Here we have someone who plays with people’s lives and health in vital blood testing. Aren’t some ethics courses long overdue?) 

Mr. Bilton makes the extremely fine point that Silicon Valley will continue to be magnetically attracted to founders equipped with a ‘reality-distortion field’ (as he termed Steve Jobs). SV will relegate Theranos to a biotech outlier. Yet as long as Silicon Valley MoneyMen like Tim Draper will back the likes of Elizabeth Holmes as long as they have a good line of (stuff), despite being embarrassingly proven not just (and only) wrong, but now perpetrating fraud, the Jobsian Myth and black turtlenecks will rise again like Dracula. (Another analogy comes to mind, but precocious children might be reading this.)

We haven’t heard the last of her.

An excellent interview by Tom Dotan of Mr. Carreyrou is podcasted on The Information’s 411 in “You’re So Vein”, which gets the award for Title of the Week (trial signup required, or listen on SoundCloud). Starting at 15:00, interesting comments on the why of Sunny Balwani and Ms. Holmes’ series of ‘marks’ including George Shultz. Also Gizmodo and Politico’s Morning eHealth newsletter.

The Theranos Story, ch. 46: “F for Fake.” SEC’s fraud charges force Elizabeth Holmes out (finally).

click to enlargeOur New Year’s 2018 prediction (after December’s $100 million loan from Fortress Investment Group): “Ms. Holmes will be removed and replaced, then the company will be reorganized and/or renamed.”

Fortress did not have to wait long or get their hands dirty. Today, the Securities and Exchange Commission (SEC) charged both founder and now former CEO Elizabeth Holmes and past CEO/president Ramesh ‘Sunny’ Balwani with securities fraud. While Mr. Balwani will fight the charges, Ms. Holmes escaped trading her black turtleneck for an orange jumpsuit by agreeing to pay a penalty of $500,000 to the SEC, give back 18.9 million shares to the company, give up her uniquely Silicon Valley perk of super-voting equity rights, and is now barred from serving as a public company director or officer for 10 years. From the Theranos release: “As part of the settlement, neither the Company nor Ms. Holmes admitted or denied any wrongdoing.”

This penalty may seem puny in the light of other securities fraud cases, but it appears that Ms. Holmes took little salary out of the company, with most of her long-gone billions in presently worthless remaining stock. 

The exact meaning of fraud, as determined by the SEC in cases like these, is not casual. We can say that we never believed the Edison or miniLabs would work despite the press hype. We can observe that patients and doctors were misled in test results, resulting in major human cost (our Ch. 22).  The fraud here is directly tied to representations made to investors that enabled Theranos’ massive funding, in multiple rounds, of over $700 million between 2013 to 2015. These misleading representations included demonstrations, reports on the functioning of its analyzers, inflating its relationships such as with the DOD, and its regulatory status with the FDA.

It also does not matter that all the funds were privately raised. The SEC in its statement firmly stated that it will treat private equity as it does public when it comes to investments (pay attention, health tech companies): (more…)

The Theranos Story, ch. 39: good news, bad news, and the ugly lawsuit news

click to enlargeIt’s that darn well again! Theranos‘ News of the Week ran the gamut from cheap, to expensive, to potentially business terminating.

Cheap was the settlement of the Center for Medicare and Medicaid Services (CMS) civil penalty against the company for a pinprick of $30,000. What remains: that Theranos cannot own or operate any labs for the next two years. As the company has downsized and done the Silicon Valley pivot to developing labs and testing platforms, the settlement is the barn door closing after the horse has exited and crossed the state line. Theranos press release,

Expensive was the settlement of the Arizona legal action brought by the state Attorney General, Mark Brnovich. $4.65 million settled matters, providing full refunds for 175,940 Arizona consumers who ordered between 2013 and 2016 approximately 1.5 million blood tests and 7.8 million results. Also on the tab are $200,000 in civil penalties, $25,000 in attorneys’ fees, and a claims administrator to dole out the refunds. While it was estimated that only 10.5 percent of tests were inaccurate, the consumer fraud charges were easier for Theranos to settle without admitting wrongdoing. A solid win for the AG as well. Background on this in Ch. 33. Ars Technica, Bloomberg, Theranos press release

Potentially disastrous is the go-ahead given to one of the many lawsuits against Theranos, also charging Elizabeth Holmes and former CEO Ramesh ‘Sunny’ Balwani. The US District Court for the Northern District of California ruled in the case brought by two shareholders, Robert Colman and Hilary Taubman-Dye, represented by Hagens Berman (Ch. 27), that most of the claims of investor fraud would proceed. Theranos’ sole success was having the charge of misrepresentation of securities under the California Corporations Code dismissed on the technicality of purchase from a third party seller. The more damning claims of direct misrepresentation by Ms Holmes and Mr Balwani, mentioning news articles and their advertising campaign, were upheld. Interestingly, the plaintiffs must now show cause why the third party sellers (Lucas Venture Group, Celadon Technology Fund, SharePost), should not be included as defendants. The stage is now set for a class-action lawsuit with potentially thousands of other investors. Theranos page on Hagens Berman website, District Court ruling document.

The final countdown is at the bank. In March, Theranos reported $150 million in cash (ch. 38), down from $200 million in January. Subtract $30,000 to CMS, $4.65 million to Arizona, legal fees, pending lawsuits, and running expenses–with no investors and revenue in–and a burn of about $50 million a quarter, it will be Taps for Theranos before end of year.

The Theranos Story, ch. 38: take our shares, but don’t sue us; Murdoch writes it off

click to enlargeWhat? They’re not toast yet? Far from it. We’ve missed the impossibly twisty soap opera called Theranos, and our latest episode holds to the previous high standard.

CEO and controlling shareholder Elizabeth Holmes is offering shareholders, supposedly from her personal holdings, about two additional shares for each one purchased. This has been offered to the investors in the 2014-2015 $600 million round who bought in at about $15-17/share (ch. 27), such as Cox and Bechtel. The deal dilutes their share cost to about $5. The caveat? Don’t sue Theranos. According to the Wall Street Journal‘s report (Yahoo Finance as WSJ is paywalled), it was approved by Theranos’s board in February, and most investors have ‘signaled that they will sign off on it’. Others are the family of US Education Secretary Betsy DeVos, the Waltons of Wal-Mart Stores Inc. and John Elkann, the Italian industrialist who controls Fiat Chrysler Automobiles NV.

One who is washing his hands is News Corp. executive chairman Rupert Murdoch. He reached a separate settlement for a nominal sum–rumored to be $1–to sell back his shares and legally write off his $125 million investment.

Others are not so lucky. Early investors before that round are not included. (more…)

The Theranos Story, ch. 37: the Object Lessons for future healthcare entrepreneurs

click to enlargeThere’s an interesting take on the Theranos debacle in Entrepreneur by management consultant/author Steve Tobak. He takes a step back from the healthcare technology that didn’t work, the big money lost and the puffery, where most of us have concentrated. Mr Tobak instead sketches a case study of a Startup House of Cards as an Object Lesson in how entrepreneurialism is NOT supposed to work.

Theranos was a Top Ten List of fatal errors. This Editor’s summary:

  1. They generated no revenue. In just over a decade, Theranos blew through hundreds of millions in funding (he says $700 million, the WSJ has estimated $900 million).
  2. They weren’t anywhere near break-even. By the time Theranos was in 40 Walgreens Wellness Centers, it should have been on a road to break-even and scalable.
  3. The company was built as a fraud from the start or near-start, much like Enron and WorldCom
  4. The company was doomed by a culture of utter secrecy (Editor’s note: none of their technology was peer reviewed, tested or published)
  5. The company was doomed by Ms Holmes’ falsity and hubris in not having a backup plan; black turtlenecks aren’t it
  6. The company was doomed by its own hype: a PR machine AND gullible press, who created a Steve Jobs-esque icon sans accomplishments out of Ms Holmes
  7. The company sold a bill of goods to EVERYONE, including multiple Federal regulators, patients and the public (Editor’s note: he doesn’t mention the Board of Directors and Stanford University!)
  8. Investors, swept up in the private equity bubble, didn’t do their due diligence (though some did)
  9. Ms Holmes had no ability to run this business, but she controlled it 100 percent so no one said boo
  10. “This is what happens when people treat ventures so casually and callously that risk becomes immaterial.”–Mr Tobak

Perhaps we should be grateful that the Edison lab didn’t actually work with all these dysfunctions on parade!

The close to this article is sobering: “Today, there are 186 venture-backed startups valued at $1 billion or more and countless companies valued above $100 million, according to CB Insights. Not too long ago, Theranos was near the top of that unicorn list with a valuation of $9 billion. We still have no idea if it’s a one-off or the beginning of a trend. Remember the Theranos saga as a cautionary tale. Nothing about it is the way business should be. Nothing.” And it will continue, because $900 million makes Theranos a Big Cautionary Tale. Hat tip to our Eye on Theranos, Bill Oravecz of Stone Health Innovations.

See here for the 36 previous TTA chapters in this Continuing, Consistently Amazing Saga

The Theranos Story, ch. 32: 155 employees out in latest layoffs, 220 left to go

click to enlargeEndlessly, flatly spinning, towards Ground Zero…. As a marketing person made redundant (US=laid off) for various reasons by companies (moving out of area, acquisition, dissolution, etc.), this Editor has zero joy in reporting that 155 Theranos employees will be discharged as it “re-engineers its operations” “towards commercialization of the miniLab testing platform and its related technologies” “aligned to meet product development, regulatory and commercial milestones.” Their Friday press release successfully buried itself on a weekend, aided by a tragic Heaping Helping of Bad News out of Fort Lauderdale. The rationale is that this is justified to better position itself to commercialize the miniLab and “related technologies”. The miniLab reportedly is a compact, microwave-sized lab that automates small volume samples by sending them for analysis to a central server which would do the full analysis, thus driving down cost and time.

Theranos is a company flailing. This Editor notes in its string of releases an endless emphasis on compliance, regulation and operational expertise, the kind of attitude and caution that should have been present years ago. The layoffs follow on last October’s involuntary exits of 340 employees and lab closings (Chapter 21). Run the numbers and there are 220 employees left to go. Will the miniLab, seemingly hastily concocted, be their salvation? Flip back to our Chapter 18 about the October AACC meeting.  Chemical laboratory professionals were distinctly underwhelmed by the miniLab and CEO Elizabeth Holmes’ presentation. Also not boding well was Theranos’ withdrawal of a miniLab Zika test FDA emergency clearance in late August, at the height of the crisis. What may be wafting is the aroma of performing seals on a hot day.

Speaking of leadership, is Ms Holmes among the fired or demoted? Highly unlikely as she controls all $9 of the company’s formerly $9 bn Unicorn Worth. Is she even taking a pay cut? Will you see her out in front of Palo Alto HQ mowing the long grass?

To nearly 500 people now wondering about their livelihood in one of the most expensive areas of the US, how damaged they will be by their association with Theranos? Despite the ‘fail fast’ mantra of Silicon Valley, there’s little tolerance by employers for those at the operational level having a failed company in their past. These people should have our empathy, not ‘guilt by association’, and as appropriate, respect for their skills which were badly used in their last situation.

One also wonders how long it will take before there is another Chapter in The Theranos Story, one that they will file via one of their multitudinous law firms–Chapter 11. Consumerist (Consumer Reports), Yahoo News.

See here for the 31 previous TTA chapters in this Continuing, Consistently Amazing Saga, including the resignation of General Mattis from the BOD (Ch. 31), Theranos’ annus horribilis (Ch. 30) and the law firm feeding frenzy (Ch. 29).

The Theranos Story, ch. 31: subtract one Marine general from the Board

click to enlargeThe Warrior Monk has left the building, to paraphrase what was said post-performance of Elvis (birthday, 8 January). Yes, James Mattis, General, USMC (ret.), has finally resigned from the Theranos Board of Directors, which was reorganized last month [TTA 3 Dec]. According to the Wall Street Journal relying on its usual ‘persons close to the matter’, he “left Theranos partly because he believed he was no longer a good fit after a broader board overhaul”.

In preparation for Senate hearings on his Secretary of Defense nomination, which begin 12 Jan, Gen. Mattis resigned from all corporate boards save General Dynamics, which was retained as to not be presumptuous of confirmation. His confirmation is more complicated than usual because he requires a Senate waiver of the seven years post-retirement requirement. Even with this, his confirmation is expected, and the resignation from the Theranos board mitigates a sticky set of questions.

The WSJ article rehashes in some detail the 2012 review of the Theranos lab which Gen. Mattis proposed while head of Central Command (CENTCOM), which ultimately was derailed at Fort Detrick, home of the US Army Medical Research and Materiel Command. However, reports are that little money was actually expended and Gen. Mattis accepted the decision.

Theranos, having shuttered its labs, is appealing the regulatory sanctions, including CMS’ ban on Elizabeth Holmes’ operating labs, and is reportedly cooperating with a myriad of civil and criminal investigations, both by an alphabet soup of Federal agencies (CMS, DOJ, FDA, SEC) and state regulators.

If the WSJ article is paywalled, search on the headline “Trump Defense Nominee James Mattis Resigns From Theranos Board”. Also MarketWatch. See here for the 30 previous TTA chapters in this Continuing, Consistently Amazing Saga, including Theranos’ annus horribilis (Ch. 30) and the law firm feeding frenzy (Ch. 29). Hat tip to reader Bill Oravecz.

The Theranos Story, ch. 30: 2016 was the awful year that was

click to enlargeTWTAwfulYTW for Theranos. This Editor, in her precocious childhood, was an admirer of the acerbically witty Tom Lehrer and the satirical album ‘That Was The Year That Was’. For our UK readers, he performed tunes such as ‘The Folk Song Army’ and ‘The Vatican Rag’ on the US version of the BBC’s ‘That Was the Week That Was’ (TWTWTW) and later on the BBC’s The Frost Report.

Certainly, this was quite the year that was for Theranos. While Mr Lehrer is long retired from both teaching math and performing, if he were still writing, he would likely be feasting on the Bottomless Well of material that ‘From $9 bn to $9’ Theranos and Elizabeth ‘Zero Net Worth’ Holmes have provided. Perhaps he would have adapted ‘Wernher von Braun‘ or ‘The Masochism Tango‘, this last dedicated to Walgreens and the investors, ‘heart in hand’ indeed. In any case, if you are seeking a tidy abstract of TWTAwfulYTW for Theranos, Engadget has it in its year-end roundup series. If it whets your appetite for more, feast on our brace of stories, with a few flashes of Wit Among The Ashes, here. Hat tip to AliveCor’s Dr Dave Albert.

The Theranos Story, ch. 28: when the SecDef nominee is on the Board of Directors

click to enlargeDoes ‘Mad Dog’ ‘Warrior Monk’ James Mattis, General, USMC (ret.) have a blind spot when it comes to Theranos? President-Elect Donald J. Trump has selected him as the next Administration’s nominee for Secretary of Defense. A remarkable leader and, yes, scholar (check his background in various sources), but he has some ‘splaining to do, in this Editor’s opinion.

This Editor leads with this question because those who have been following the Continuing Saga (which, like the Nordics, seems never-ending) know that Theranos stuffed its Board of Directors (BOD), prior to last October, with a selection of Washington Luminaries, often of a great age: Henry Kissinger, George Shultz, Sen. Sam Nunn, Sen. Bill Frist (the only one with an MD), William Perry and Gary Roughead, a retired U.S. Navy admiral. It also reads like a roster of Hoover Institution Fellows except for Sen. Frist, who sticks to the East Coast. Another interesting point: Hoover is based at Stanford University, an institution from which Elizabeth Holmes dropped out to Follow Her Vision. Obviously, there was an accompanying Vision of Washington Pull.

Also joining the BOD as of July 2013, well before The Troubles, and shortly after his retirement, was Gen. Jim Mattis (also a Hoover Fellow, photo above). When the Washington Luminaries were shuffled off to a ‘board of counselors’ after the Wall Street Journal exposé hit in October, Gen. Mattis remained on the governing BOD. Unlike his fellow Fellows, he had actually been involved with a potential deployment of the lab testing equipment. As we previously noted, as commandant of US Central Command (CENTCOM is Middle East, North Africa and Central Asia), he advocated tests of the Theranos labs under in-theatre medicine conditions in 2012-13. Leaked emails cited by the Washington Post (in Gizmodo) and also in the Wall Street Journal indicate the opposition from the US Army Medical Research and Materiel Command at health-intensive Fort Detrick MD, which oversees medical research, based on the undeniable fact that the equipment and the tests weren’t FDA-cleared, which remained true two years later…and which Gen. Mattis tried to get around, being a good Marine. Nonetheless, the procurement of Theranos equipment was halted. DOD permitted him to join the BOD after retirement as long as he was not involved in any representations to DOD or the services. (Wikipedia bio)

Yesterday, Theranos also announced that it is dissolving (draining?) the ‘board of counselors’. They led with a BOD shuffle, with Daniel J. Warmenhoven, retired chairman of NetApp, replacing director Riley P. Bechtel, who is withdrawing for health reasons. (Warmenhoven also serves on the Bechtel board, so they are keeping an eye on the estimated $100 million they invested). Gizmodo and Inc. While effective January 1, the Theranos website has already scrubbed the counselors and updated the BOD.

However, Gen. Mattis remains a director, until such time as he actually becomes Secretary of Defense, which is not a lock for Senate approval by a long shot. First, he requires a Congressionally approved waiver demanded by the National Security Act of 1947, as he has been retired only four years (as of 2017) not the required seven. Second, his involvement with Theranos has already been questioned in the media. After all, it is a Federal Poster Child of Silicon Valley Bad Behavior: censured by CMS, under investigation by SEC and DOJ. It is a handy, easily understandable club with which to beat him bloody (sic). WSJ’s wrapup.

In this Editor’s opinion, the good General should have left in October, but certainly by April when CMS laid the sanctions down, banning Ms Holmes and Mr Balwani from running labs for two years in July. What is going on in the ‘Warrior Monk’s’ mind in sticking around? Is there anything to save? 

If the WSJ articles are paywalled, search on ‘Gen. James Mattis Has Ties to Theranos’ and ‘Recent Retirement, Theranos Ties Pose Possible Obstacles for Mattis Confirmation’.  Oh yes…see here for the 27 previous TTA chapters in this Continuing, Consistently Amazing Saga.

The Theranos Story, ch. 25: is the nadir the $400,000 harassment of whistleblower Tyler Shultz?

click to enlargeA story to make your blood…boil. Tyler Shultz is a 26 year old Stanford University grad with a biology undergraduate degree. He ‘fell in love’ with the Theranos vision of quick small blood sample testing after visiting his grandfather’s home near the campus and meeting, of all people, Elizabeth Holmes in 2011. Tyler snagged a summer internship and then a full time job during their salad and steak days (September 2013). He worked on the assay validation team, which verified the accuracy of blood tests run on Edison machines before they were deployed in the lab for use with patients.

Then it all went sideways…and down. Ms Holmes was at his grandfather’s because he is George Shultz, 95 year old former secretary of state and Fellow at the Hoover Institution based at Stanford. Mr Shultz was one of the numerous Washington alumni lending luster to the Theranos board (now advisers), such as Henry Kissinger, Sam Nunn, James Mattis and Bill Frist (the last the only one with an MD).

Tyler Shultz soon discovered, like many new graduates, that his dream job wasn’t all that it was cracked up to be. Except that it wasn’t the hours or the quality of the snacks. He discovered that the Edison machines had highly variable results when tests were rerun with the same blood sample–and they routinely discarded the outliers from the validation reports. Edison testing for a sexually-transmitted infectious disease had a claimed 95 percent sensitivity. “But when Mr. Shultz looked at the two sets of experiments from which the report was compiled, they showed sensitivities of 65% and 80%.” It only got worse when he moved to the production team, where quality control standards were routinely flunked and President Sunny Balwani pressed lab employees to run the tests anyway. Mr Shultz went directly to Ms Holmes, twice, received a nastygram from Mr Balwani for the second, and quit–but not before anonymously sending results to the New York officials who administered a proficiency-testing program and who confirmed that the results sounded like ‘PT cheating’.

The rest of the story by John Carreyou is one of corporate harassment and family estrangement: legal harassment (including private investigators) by none other than David Boies’ law firm on the pretext of ‘confidential information’; the manipulation, currying of favor and misleading of a great but aged man; and a family’s trust fractured if not broken, despite the grandson being proven right, ironically, by the same Washington agencies that his grandfather so loyally served. Mr Shultz is now working on the Cloud DX team for the VITALITI Diagnostic Android Application in the running for the Qualcomm Tricorder XPRIZE. Wall Street Journal  See here for the 24 previous TTA chapters in this Continuing Saga.

The Theranos Story, ch. 22: the human cost of lab error (updated)

click to enlargeSave this one for the coffee or lunch break. What is the cost of a lab error on the human psyche? It can be mildly upsetting to you and your doctor, warning of a developing condition and some changes have to be made–or make for a very bad day/week/months. It can be falsely reassuring or simply confusing.

We know that in April, Theranos flunked a CMS review, and in May voided all test results from its proprietary Edison devices from 2014 and 2015, as well as some other tests it ran on conventional machines. The results were not only off, but way off, according to the WSJ. “Notes from the CMS inspection show that 834 out of 2,890 quality-control checks run on the Edison in October 2014, or 29%, exceeded the company’s threshold of two standard deviations from its average result. Standard deviation is a statistical measurement of variation. In addition, 80% of the 834 quality-control checks that raised a red flag under Theranos’s internal standards were more than three standard deviations from its average result, the inspection notes show.”

They also failed to notify patients for weeks or months, and often not until forced to. At least 10 lawsuits have been filed in Arizona and California. Some of the human stories of Theranos’ improbable lab results, which included tens of thousands of patients, with the cost of retesting, repeated doctor visits and agonizing suspense :

  • After five widely different Theranos blood coagulation tests in six weeks, a retired marketer living in Arizona and his doctor so distrusted the results that the latter recommended that he stop taking warfarin and switch to a milder medication. This patient found out only last Friday that Theranos had corrected a September 2015 test showing his blood taking more than six times longer than normal to clot. The other four tests showed the warfarin wasn’t thinning his blood enough. Contradictory results confusing both doctor and patient on treatment.
  • A thyroid cancer survivor got thyroxine results (T4) from three tests conducted in October 2014. The extremely high results could have indicated hyperthyroidism at the least, or a more serious condition. The results–false after retesting failed to confirm.
  • A breast cancer survivor had extremely high levels of estradiol, which could have been produced by a rare adrenal tumor that can secrete estradiol or an elevated risk of breast-cancer recurrence. Again, false results but found only after retesting.

The comments under the article are worth the long scroll. (They are running 98 percent in favor of Holmes for Prison 2017. Also there are a few shots at Walgreens’ role in legitimatizing Theranos by putting their centers in store; this embarrassing part of the story isn’t over, in this Editor’s opinion.) What is evident–fraud perpetrated on patients and doctors–and anyone who invested. David Boies, their legal supremo and board member, is gonna have a full docket between this and the various legal actions taken by the Alphabet Agencies.

Agony, Alarm and Anger for People Hurt by Theranos’s Botched Blood Tests. If the WSJ is paywalled, search under the headline text.

See here for the agony of TTA’s 21 previous Theranos chapters. We hope that John Carreyrou and the WSJ investigative team, which we’d assume includes Mr Weaver, this article’s author, are awarded the Pulitzer Prize.

The Theranos Story, ch. 19: the dramatic denouement, including human tragedy

click to enlargeThe deconstruction of Theranos continues, con il dramma, rounding back to those who touted it. There isn’t all that much new in Nick Bilton’s Vanity Fair article, but it adds context and color to this (literally) Bloody House of Smoke and Mirrors. (Ah, where’s Christopher Lee when you need him?–Ed.) There’s the usual Inside Baseball of closed-door meetings in ‘war rooms’, G150 jetting to awards, bodyguards, threatening lawyers, crisis managers, COO ‘enforcers’ (Sunny Balwani) and playing the Silicon Valley investor game (with Google Ventures taking a very smart pass). Where this gets unusual is the portrait of Elizabeth Holmes as an obsessive, secretive, blondined Steve Jobs knockoff from the age of 19, with a hot idea that never matched scientific reality from the start, but with a great line of ‘making the world a better place’ magnified by Silicon Valley’s incessant, We’re The Top And You’re Not narcissism.

Even Narcissus ultimately saw a fool in that pool. Played and tarred to a greater or lesser degree were: the only major SV VC lured in, Draper Fisher Jurvetson, and off-SV investors like mutual funds and private equity have lost it all; Fortune, Forbes, CNN plus much of the tech and financial press; and respected people lured to the board like Marine Gen. James Mattis, who had initiated the pilot program in DOD, Henry Kissinger and former Senator Bill Frist MD. Then the alphabet agencies marched in after the author: FDA, CMS, SEC and DOJ.

Oh yes, that Zika test announced in early August? Withdrawn at end of August. Ms Holmes is appealing her two year lab ban. But she still has absolute control of what’s left of the business. Business Insider

Finally, the lede in many articles is the suicide of British chief scientist Ian Gibbons and Ms Holmes reaction. Already ill with cancer, (more…)

The Theranos Story, ch. 18: Is the ‘miniLab’ the Real Edison, or The Great Oz 1.0?

click to enlargeIs the Great Oz Behind the Curtain? Updated for The Box and additional articles. Before a skeptical audience Monday afternoon at the American Association for Clinical Chemistry‘s (AACC) annual meeting in Philadelphia, Theranos‘ CEO Elizabeth Holmes, due to be banned from the industry by CMS for lab violations, unveiled a new lab technology. According to Ryan Cross in the MIT Technology Review, “Holmes claimed her company had developed a sophisticated “miniLab” capable of carrying out an array of tests, including detecting the Zika virus, from a finger prick of blood.” A cube-like box, developed in secrecy, she called it a “single platform” able to carry out a wide array (or several–depending on what quote you read!) of different test types using small volumes of blood (apparently finger sticks). The device will be small, portable and directly connected to the internet to centrally send and verify test results. Ms Holmes actually took questions from a three-person scientific panel. When asked if she would be sharing the device with other researchers, she said she was “working on it right now.” It is not, of course, FDA-approved or in production.

Updated for video and new articles (as of 8/19/16).

  • MedCityNews’ Stephanie Baum must have some OSS/CIA blood in her, because it appears she’s beaten everyone on the miniLab Box picture plus posting the Theranos presentation video, which went up via AACC’s YouTube site within hours of the presentation. Other commitments prevent me from an analysis of the hour until later, but gone is the black turtleneck, remaining is the talent for tap dancing around hard facts. The comments in the article and from elsewhere echo the profound skepticism and cynicism found in the MIT and WaPo articles. Yes, the ‘Sympathy for the Devil’ intro was dark humor, served up the way we like it!
  • Bloomberg interviews attendees (scientists, clinical directors, professors, doctors) who believe they were baited and switched. The bait was the justification for Edison performance. The switch was The Box–a new technology, untested, untried and not even peer reviewed–that simply crunched down multiple existing tests into one container.
  • (Updated 8/19) AACC’s published article was short and straight up. “(Dr Steven) Master told Holmes that her data “fell far short” of what he expected based on the wide menu that Theranos promised previously.” Plenty of promises from Ms Holmes at the end, but if CMS has their way, which is likely, Ms Holmes’ “I’ve made the decision to double down and stick by it no matter how hard the path” and to be involved with AACC in the future, will be more empty Theranos promises.

Also WaPo, TechCrunch and POLITICO Morning eHealth

Is Theranos–and Ms Holmes–too far ‘gone’ to be credible or funded? Will there even be a Theranos company to develop this? Will Ms Holmes remain in the business through successfully appealing her imminent ban? The only sensible conclusion is that we’ll believe the technology–and her–when we see it is properly and independently verified–and operated by a company with proper governance and controls.

Stay Tuned to See if The Fix Is In.

Thumb through the prior 17 chapters of the Theranos Story here. Hat tips to @EdifInstruments and Editor Chrys Meewella for the links (WaPo and MIT respectively).