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

[grow_thumb image=”https://telecareaware.com/wp-content/uploads/2016/04/Yak_52__G-CBSS_FLAT_SPIN.jpg” thumb_width=”150″ /]Endlessly, 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

[grow_thumb image=”https://telecareaware.com/wp-content/uploads/2016/12/jim_mattis.jpg” thumb_width=”150″ /]The 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

[grow_thumb image=”https://telecareaware.com/wp-content/uploads/2016/11/jacobs-well-texas-woe1.jpg” thumb_width=”150″ /]TWTAwfulYTW 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

[grow_thumb image=”https://telecareaware.com/wp-content/uploads/2016/12/jim_mattis.jpg” thumb_width=”150″ /]Does ‘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?

[grow_thumb image=”https://telecareaware.com/wp-content/uploads/2016/11/jacobs-well-texas-woe1.jpg” thumb_width=”150″ /]A 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)

[grow_thumb image=”https://telecareaware.com/wp-content/uploads/2015/11/upside-down-duck.jpg” thumb_width=”150″ /]Save 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

[grow_thumb image=”https://telecareaware.com/wp-content/uploads/2016/04/Yak_52__G-CBSS_FLAT_SPIN.jpg” thumb_width=”150″ /]The 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?

[grow_thumb image=”https://telecareaware.com/wp-content/uploads/2016/04/Yak_52__G-CBSS_FLAT_SPIN.jpg” thumb_width=”150″ /]Is 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).

The Theranos story, ch. 17: closing the barn door after the horse

[grow_thumb image=”https://telecareaware.com/wp-content/uploads/2016/04/Yak_52__G-CBSS_FLAT_SPIN.jpg” thumb_width=”150″ /] And it may work, though the horse is in the next county. Late last week, with American eyes elsewhere, Theranos announced that they hired two executives with regulatory responsibility–a chief compliance officer and an VP regulatory and quality–and formed a new board committee focused on same. The CCO is Dave Guggenheim, the former assistant general counsel for regulatory law at HIT/medical distribution giant McKesson. The VP, Daniel Wurtz, comes from a similar senior director position at biotech Thermo-Fisher Scientific.

The country maxim, ‘closing the barn door after the horse has bolted’, applies. In fact, the horse is in town and having a growler of beer at the local tavern. The Newark, California lab is shut and the principals, including the CEO Ms Holmes, are technically prohibited from operating a lab for at least two years (that means you, Ms Holmes) starting in a month. Messrs Guggenheim and Wurtz (or similar) should have been on board years ago. Even small companies in our field realize they HAVE to do this!

This also doesn’t affect the interesting interest that DOJ and SEC have in Theranos. [TTA 10 July]

However, this Editor will take the contrarian view that somehow, some way, the ‘fix’ is being worked out, if not in. Don’t make reservations for the fire sale quite yet. The ban on Ms Holmes won’t take place for another month, minimum. That gives time for David Boies, their legal supremo, and his firm to stall for more time, and time for some calls to ask favors from friends, of which he has many in this administration. More than likely, Boies on behalf of Theranos will appeal the CMS rulings to an administrative judge. Ms Holmes may take the hit, but may get a handsome payday to depart despite her reported control, if the investors can salvage something out of the company.

At HQ, they may be rehearsing saying ‘mea culpa, mea culpa, mea maxima culpa’ three times, kneeling deeply, in preparation to Going Forth And Sinning No More.

The Object Lessons taught by the Theranos Troubles, to us in healthcare tech, continue.

WSJTheranos Hires Compliance, Regulatory Executives  (more…)

More reflections on, significance of the Theranos quagmire (updated)

[grow_thumb image=”https://telecareaware.com/wp-content/uploads/2016/04/Yak_52__G-CBSS_FLAT_SPIN.jpg” thumb_width=”150″ /]Theranos’ spin towards the Auger In continues. Truth or Consequences are apparent. So are setbacks.

Wired has put together a timeline of the key events in The 9 Events That Have Pretty Much Doomed Theranos, most of which our Readers in following our coverage (index here from 2013) are already familiar with. One interesting point is #7, which touches on another gift to the legal profession–the class action lawsuit. Eight lawsuits are already in process, and at least one names former partner Walgreens Boots.

SEC and DOJ’s interest. The SEC, limited in its action because Theranos got big without going public (see below for more), is likely seeking misrepresentation of technology to investors–as in, ‘it really didn’t work’. Penalties may include repayment or settlements to investors and barring principals from ever leading a public company. The DOJ will likely focus on consumer impact. Knowing that your blood tests are inaccurate but continuing to sell them violates all sorts of Federal health regulations, and can earn the principals orange mock turtlenecks and a long stay in a place with iron bars, pesky regulations and no choice of wardrobe. Sadly, Theranos’ legal counsel and board member David Boies won’t have a chance to unleash one of his favorite intimidation weapons, the libel lawsuit. Instead, he’ll be uncomfortably playing defense (but for how long?) Give the man a crying towel, and remind him to bill in advance. Wired (from April)

*Updated: Here’s the CMS letter, courtesy of the WSJ. (If John Carreyrou doesn’t receive a Pulitzer Prize, the fix is in!–Ed.)

The market demonstrated inefficiency in allowing companies like Theranos to get big without going public. You cannot short or sell the stock (a negative ‘opinion’) which demonstrates that investor-backed Unicorns represent ‘incomplete markets,’ according to Robert Shiller’s Efficient Markets Hypothesis. Of course, before going public, the SEC would have demanded disclosure–another reason why Theranos (and possibly other Unicorns) aren’t. Forbes.

‘Theranos has probably set back the tremendously promising field of microfluidics by a decade.’ An investor who was rooting for Theranos (but didn’t invest) recounts the dodgy behavior of entrepreneurs from eToys.com to Tesla. ‘Hype is what entrepreneurs do best’; fabbed-up PowerPoint decks are par for the course. “Sadly, the journey from charisma to coercion to lying is quick and often complete.” Ms Holmes, you have a lot of company. When Startups Put The Fab in Fabricate. (WSJ; if paywalled, PDF attached)

Where do we go from here? We’ll close with advice to startups in biotech and medical innovation: pace thyself, know thyself. What’s needed: an internal culture amenable to science–and external regulation–and knowing when to apply the brakes to prevent slamming into The Wall Marked Failure. (Mentioned is a useful tool called a pre-mortem) Wired

Theranos denouement: CMS closes lab, fine, 2-year ban on Holmes (breaking)

[grow_thumb image=”https://telecareaware.com/wp-content/uploads/2016/04/Yak_52__G-CBSS_FLAT_SPIN.jpg” thumb_width=”150″ /]Breaking News. Theranos has been slapped very soundly by the Centers for Medicare & Medicaid Services (CMS) for violations arising from operations at their Newark, California laboratory. The fine is not disclosed. CMS has revoked the lab’s certificate and also prohibits the owners and operators of the lab from operating a lab for at least two years. That means that Elizabeth Holmes, the CEO, her management and anyone immediately involved with the Newark lab is effectively out of a job.

As the Theranos press release was issued well after hours Thursday night US Eastern Time, there’s no mention of the board actually removing her, but that is another shoe that this Editor expects to drop sooner, not later. COO Sunny Balwani was removed in May [TTA 19 May] Who is not tainted who can actually run the company? Is there a capable person in the industry who wants to touch it? As has been revealed, Ms Holmes still controls the company [TTA 27 Apr].

The revocation will be in effect in 60 days, according to the Wall Street Journal*, but the Newark lab has been closed. There is no mention of the Palo Alto lab which was also under scrutiny [TTA 20 Apr].

The details appear to be lifted or nearly lifted from the CMS order, and are quoted directly from the Theranos release: (more…)

Unhappy endings? HealthSpot’s remains to Rite Aid, Theranos’ story to Hollywood

HealthSpot Station’s assets to Rite Aid, minus the ‘froth’. On Monday, drug store chain Rite Aid won the US Bankruptcy Court in Columbus, Ohio’s mandated auction for the inventory, most assets and IP for its entry bid of $1.15 million. According to Columbus Business First (subscription only), a touted second bid by a central Ohio investor group was $1 million–and stayed right there with no second bid. This group had invested $650,000 before HealthSpot entered Chapter 7. A dark horse third bidder, which came in at the last minute, never put money on the line.

The Ohio business group leader, local assisted living facility owner Paul Gross, interestingly maintained his faith in the kiosk concept to Columbus Business First in an earlier interview, rapping the prior management for squandering approximately $47 million (more, given Xerox‘s never-disclosed investment) on office furniture, lavish executive salaries and misbegotten marketing (quoted in MedCityNews). 25 of the kiosks were in Rite Aid locations in Ohio and others with Cleveland Clinic, but there are 137 still ‘in the box’. Perhaps ‘misbegotten’ should be applied to the concept (kiosks too big, expensive) and not the marketing communications, which in this Editor’s professional judgment were strong and appealing, but ran into the ‘lipstick on a pig’ wall.

One wonders what Rite Aid, in the throes of its own difficult merger with Walgreen Boots Alliance, will do with the assets. TTA’s earlier stories on HealthSpot.

Theranos the Movie, starring Jennifer Lawrence. Co-starring Walgreens? ‘Hunger Games’ star Jennifer Lawrence has reportedly agreed to star in ‘The Big Short’ director Adam McKay’s adaptation of the story. (Fortune) Certainly there is a resemblance to CEO Elizabeth Holmes Frogeyed Sprite (‘Bugeyed’ to us Yanks–Ed.) crossed with Steve Jobs. Ms Lawrence has already played a young, aggressive, come-from-nada inventor of household gadgets in ‘Joy’. The Theranos story is appearing to be the ‘Joy’ story in reverse. Suggested title: ‘The Royal Scam’? (credit Steely Dan, circa 1974). ‘Less Than Zero’ (Bret Easton Ellis) is taken, now describing Ms Holmes’ net worth according to Forbes.

Mr McKay will be ripping from the headlines in progress, should the movie actually be made. (more…)

Nail in the coffin hammers home: Theranos voids, corrects 2 years of test results

[grow_thumb image=”https://telecareaware.com/wp-content/uploads/2016/04/Yak_52__G-CBSS_FLAT_SPIN.jpg” thumb_width=”150″ /]Tens of thousands of lab results 2013-2015 voided, “corrections” sent. L’affaire Theranos continues, with the not-so-surprising action of Theranos to void all of its Edison machine testing results, from all labs, as well as many processed on conventional equipment during those years.

According to the Wall Street Journal, Theranos told CMS during its lab inspections that they ran 890,000 tests a year, so we are between 1.5 and 2 million tests being, at minimum, voided. The Edison was used for 12 out of 200 tests, at least initially, with conventional machines performing the rest.

The voiding was verified by John Carreyrou of the WSJ by cross-checking his sources with Phoenix-area medical practices (the Walgreens marketing area), which confirmed receiving corrected test reports. One doctor reported that many of the voided results were for calcium, estrogen and testosterone tests. Here is where it cuts to danger levels: “The doctor said one corrected report is for a patient she sent to the emergency room after receiving abnormally elevated test results from Theranos in late 2014. The corrected report from Theranos now shows normal values for those tests, according to the doctor.”

But how can you send corrected results, which would require a rerun, of samples at least a year and perhaps two years old? It’s not clear if this pertains to standard tests run on miscalibrated machines (see below on Siemens) or somehow Edison tests were re-evaluated.

This reads like a last ditch effort to stay out of the Alphabet Monster’s clutches (CMS, FDA, DOJ, SEC), or at least survive their squeeze. COO Sunny Balwani was bid adieu last week, along with the company adding three members with scientific expertise to one of its many boards. Of course, as we previously noted, these boards are Silicon Valley Sock Puppets. The one to watch is legal Attack Dog David Boies (to whom the First Amendment and a free press are so much tissue paper to be ripped) who also sits on the governing board–politically well wired and the kind of bully attorney you call in when you are facing Big Trouble and need Big Defense–or Offense.

Walgreens Boots–reportedly fit to be tied, because Theranos won’t disclose the extent of the corrections, and surely assessing its legal options. Siemens must be equally unhappy that its equipment was 1) miscalibrated by Theranos and 2) Theranos didn’t monitor test water purity; thus they have become inadvertently tainted.

One must wonder if founder Ms Holmes is considering the fit and finish of orange turtlenecks, or residency in a country with no US extradition treaty. For the company, the flat spin above is likely non-recoverable. Sadly, Clipper Theranos will crash down on other, far more honest innovative companies lined up on the runway. Wall Street Journal (if paywalled, copy and search on the headline); Forbes, Ars Technica. Our Theranos dossier here.

‘Silicon Valley Tech Press’ blamed in the Theranos buildup; WSJ threatened

[grow_thumb image=”https://telecareaware.com/wp-content/uploads/2016/04/Yak_52__G-CBSS_FLAT_SPIN.jpg” thumb_width=”150″ /]A fascinating view from an ironic source. Vanity Fair’s short article tags the buildup of Theranos and its founder/CEO Elizabeth Holmes to a purposefully gullible Silicon Valley Tech Press and their moneymaking conferences. While not naming specific publications, it cites TechCrunch’s Disrupt as an early builder-upper of Ms Holmes (drawing blood onstage, how daring!). The operating thesis here is that the tech press vetted her with uncritical and fawning coverage, which led to profiles and shiny articles in the New York Times, the New Yorker and ….Vanity Fair, which also featured Ms Holmes at their 2015 New Establishment Summit. It’s a classic PR strategy to me, one that any skilled marketer has in their playbook (Ed.–it also works in reverse, having mainstream press vet a technology sold B2B), and one that evidently worked.

One would think that writers and editors with some biotech and science knowledge would raise more questions. The author, Nick Bilton, critically outlines the ‘Game of Access’ underpinning the tech press and blogger business model: you say nice things and play ball, you get a preview of the latest gadget or a sitdown with the CEO. If you don’t, you’re shut out. So writers don’t ask tough questions, probe hard enough, or tell the truth about where the facts are leading them, because if they do, there goes the access and the sponsorships, as well as your job. While the former doesn’t apply to your Editors, many of us who write also hope that we uncover a technology that benefits people, or is even revolutionary. We like a bracing story.

However, Mr Bilton, perhaps mindful of the cart he rode in on, doesn’t scoop an equal share of blame onto the ‘mainstream’ press. To this Editor’s mind, the Ken Auletta profile in the New Yorker should have been stopped by the New Yorker’s EIC and sent back to Mr Auletta with a blue-penciled “DIG DEEPER”. This excerpt is from the VF article:

Auletta acerbically noted that the technology behind Theranos was “treated as a state secret, and Holmes’s description of the process was comically vague.” She told him, for instance, that one process occurred when “a chemistry is performed so that a chemical reaction occurs and generates a signal from the chemical interaction with the sample, which is translated into a result, which is then reviewed by certified laboratory personnel.”

Say wot? Sheer gobbledygook. For the WSJ investigative reporter John Carreyrou, who read this and eventually blew the lid off Theranos, this was caviar on toast too delicious to pass up. (Vanity Fair, on the other hand, was too busy making Ms Holmes one of its New Establishment, but investigative reporting has never been one of their strong points. Another reason why this article is an interesting read.)

A side note: Ms Holmes kept on refusing to disclose, even to VCs, the blood analysis process as a technology too secret to share, even with fellow researchers to get verification and validation. And that led to very few truly major VCs investing in the formerly $9 bn valued company, a point Mr Bilton relishes.

The final revelations in the article–truly the lead–should scare anyone who values a free press. They are the bullying tactics taken by Theranos’ legal team led by that new governing board member, David Boies, to intimidate both Mr Carreyrou and the WSJ from their investigative reporting. Mr Bilton’s source describes the team marching into the WSJ office in June, threatening legal action on the proprietary information Mr Carreyrou supposedly had (he did have internal documents). After repeatedly denying all requests for an interview with Ms Holmes, the WSJ went with the story in October, and the rest is history. Mr Boies now has his hands full elsewhere with other types of letters: CMS, SEC, DOJ and FDA. And Ms Holmes is no longer making herself available to the media, even to her former friends in the tech press. The Secret Culprit in the Theranos Mess

Theranos/FDA update: nanotainers are ‘uncleared medical devices’

And the battering of their USP continues. On the heels of Walgreens Boots Alliance (which this week proposed a merger with #3 Rite Aid to create the largest by location US drugstore chain) putting a screeching halt on expanding its 41 Theranos testing locations, the FDA has told Theranos that its nanotainers are actually ‘uncleared medical devices’ which further violate because they are being shipped over state lines. The company was also scored on handling complaints poorly, keeping poor records and failing to conduct quality audits including on the manufacture of the nanotainers. These were revealed on redacted FDA Form 483s filed as a result of a month-long inspection ending in mid-September, which were published per a Freedom of Information Act (FOIA) request. According to MedCityNews, the nanotainers were mistakenly classified as Class I and not II. Fortune quotes one of the reports: “The design was not validated under actual or simulated use conditions,” (more…)

The Theranos Kerfuffle: a setback, but is it for the best? (updated)

[grow_thumb image=”https://telecareaware.com/wp-content/uploads/2015/10/question_mark.jpg” thumb_width=”120″ /]Some clarity emerges from the controversy around Theranos and last week’s Wall Street Journal exposé [TTA 16 Oct]. Last week’s rebuttal/denial released by the company said remarkably little, which disturbed Roger Parloff, the Fortune writer who profiled the company in June 2014’s high-profile cover story. He failed to reach CEO Elizabeth Holmes, who on her break from an all-day with the Harvard Medical School Board of Fellows, taped a segment with CNBC stock tout Jim Cramer (a questionable priority indeed–Ed.) Fortunately he received more specific answers via email from General Counsel Heather King. It clarifies among other things that venipuncture, not finger stick, is used in the majority of their tests in practice, and that dilution of samples is within industry practice for use in third-party analyzing machines. There also seem to be two sides to the proficiency-testing story. (Oddly, no mention of the sensational claims around British biochemist Ian Gibbons who was key to Theranos’ patent development and the alleged legal threats to his widow.)

For those who have difficulty getting through the WSJ paywall, Mr Parloff’s summary of the WSJ article’s main points is helpful. His conclusion: Theranos is wisely ‘dialing back’ its USP on drawing blood through finger stick to “Smaller samples. Smaller needles. Better experience.” (A neat pivot from what Theranos ‘made their bones’ on and still features–tiny finger-sticks.) His open-ended question (for, presumably, the next article): can it profitably run its low-cost testing business when it’s using the same analyzing machines as the big testing labs; and while cheaper, can doctors and patients trust the Theranos tests (which are a matter of health, and perhaps life and death) if they’ve flunked their first test at transparency?

Another view from Health 2.0 supremo Matthew Holt over at his Health Care Blog is that for Theranos, this blow is eminently recoverable if they play their cards right. Witness the recovery made by 23andMe, now in the good graces of FDA after having blown it badly to near-shutdown. (more…)