TTA’s week: data’s everywhere and hopeful, Citizen Scientists and Innovation, events, more

 

Data is everywhere this week, from the future of patient-generated data to AI. Citizen Scientists aid innovation. MedStartr and ATA2017 (save 15%!) events. 

From despair to hope? New study charts future of patient-generated data in care delivery (It’s better in 5 years. Can we wait?)
Upcoming MedStartr healthcare events in NYC; #RISE2017 videos online (The places to be in the next few weeks, and if you missed #RISE2017 catch it here)
AI as patient safety assistant to reduce, prevent adverse events (A hopeful take on an urgent issue)
#ShareTheHealth: spare Android phone processing, used fitness trackers, aid health research (Citizen Science innovations)

and: ATA 2017 Telehealth 2.0 Conference, Orlando: TTA Readers attend for less! (The place to be in April–more detail below)

Telemedicine may increase plan cost, the Idaho legislature takes action, aging tech 2017 trends, diabetes apps, Radio 4 CQC debate features Editor Charles, more. 

Telemedicine may drive up medical utilization, increase cost: RAND Health study (Yet it worked as intended)
Idaho legislature begins repeal of telemedicine abortion ban (Editor Chrys’ follow up)
Leeds, Harrogate care homes pilot telehealth system for residents (UK) (Another small test)
Technology for Aging in Place, 2017 edition preview (Some surprises here, debated)
Debate on Care Quality Commission’s position on online prescription services on Radio 4’s TODAY (UK) (Editor Charles now radio star)

CHANGED DEADLINE Calling all diabetes prevention apps: may be your chance for greatness! (Our Mobile Health/NHS England–application due 15 March)
A cornucopia of events and opportunities (UK/EU) (Editor Charles fills in your health tech calendar)

Previous articles of continued interest:

#HIMSS17 roundup: machine learning, Proteus, Soon-Shiong/NantWorks’ cancer vax, Uniphy Health, more (From AI-assisted workflow technologies to the Soon-Shiong cancer vax controversy)
Here’s Howz: now electricity consumption as elder minder (UK) (Telecare 3.0?)
Utah telehealth expansion bill passes Senate and House (Lawmakers working together)
HIMSS17 dispatches: Mayo maps neonate telemedicine, Amwell-Samsung, Samsung-T-Mobile (Including IoT for senior care)

HIMSS17 news flashes: Lenovo, Orbita, Tactio, Garmin, Parallax, Entra Health, Philips, IBM (Some setbacks for Watson Health)
The Theranos Story, ch. 37: the Object Lessons for future healthcare entrepreneurs (An MBA in what not to do)

The Theranos Story, ch. 36: Their money–and time–are running out (The start of the denouement) (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. 36: Their money–and time–are running out

click to enlargeA garage sale soon for Theranos? A report in the Wall Street Journal, citing sources on a January investor call, revealed that Theranos has $200 million on hand, but zero revenue in 2015 and 2016. $200 million on hand sounds like–and is–a lot. But Theranos is, once again, oh so special. It’s less than 25 percent of their over $900 million raise. They’ve made no money in the past two years and are likely to make none in 2017 with an unapproved miniLab. Their CEO cannot run a lab by Federal action. They’ve laid off all but 200+ employees, all of whom with any shred of intelligence are job hunting. Then think of all the lawsuits: Walgreens Boots seeking to claw back its $140 million, individual and class actions on behalf of other investors, and the looming Arizona state fraud action. It’s a mere pittance when Theranos has to hire armies of attorneys who charge Billable Hours Galore and will likely lose some if not all of the lawsuits. This Editor is making an educated guess that at least one legal team is working on a bankruptcy filing. Fortune, TechCrunch, Business Insider

Forbes, like TechCrunch once a hyper-overdrive cheerleader for Ms Elizabeth Holmes and Theranos, offers up a profile of John P.A. Ioannidis, MD, DSC who holds the C.F. Rehnborg Chair in Disease at Stanford University and is director of the Stanford Prevention Research Center at the School of Medicine. Dr Ioannidis, according to the article, was the first to raise questions about Theranos’ methodology based on the obvious–that Theranos had published nothing in scientific journals. Theranos’ general counsel then reached out to suggest co-authoring an article with Ms Holmes in a major journal. Per Dr Ioannidis, it would support “the company view that FDA clearance offered the highest possible level of evidence for any diagnostics blood test technology.” They also said, “recant your existing views and writings about these misgivings.” He did neither, to his credit. The article interestingly does not explore the heat he, in as prestigious a position as he was, must have received, based on the close ties this Editor and others have noted between Stanford and Ms Holmes. Hat tip to Bill Oravecz of Stone Health Innovations

“This is the way the world ends/Not with a bang but a whimper.” T.S. Eliot puts a fine point on a Hollow Company, indeed.

See here for the 35 previous TTA chapters in this Continuing, Consistently Amazing Saga.

The Theranos Story, ch. 35: Arizona lab in violation, is there a biotech ‘Theranos effect’?

click to enlargeAnd we were starting to grow nostalgic for our Weekly Episodes! One would expect Nary A Peep from Theranos until the lawsuits start to move forward, they set up another Board of Experts, and/or if the Alphabet Agencies (FDA, SEC, DOJ) decide to take their own actions. A short article out of the (thoroughly paywalled) Wall Street Journal, summed up in MarketWatch, confirms that as suspected, the September 2016 Federal inspection of the Scottsdale, Arizona lab turned up multiple lab and patient notification violations. According to a Federal inspection report cited in the WSJ article, lab staff inaccurately configured a machine processing blood coagulation tests; “Theranos additionally failed to verify that devices’ precision or accuracy were in line with their manufacturer’s instructions for tests such as those for blood-glucose, pregnancy and triglycerides.” Patients were not notified of potentially inaccurate diabetes test results. This provides an extra entreé for the dining pleasure of the Arizona Office of the Attorney General (OAG), which last month put out a bid solicitation for outside counsel to assist in planned actions against Theranos for fraudulent blood testing [Ch. 33]. Hat tip to Bill Oravecz of Stone Health Innovations

No Theranos Effect? The biotech, VC and investor community has put on its Game Face and declared everything’s just fine, and move on. Theranos–now seen as an outlier. After all, they didn’t present their data and kept everything tightly under wraps. (But two years ago, who questioned that? Few.) Unicorns continue to romp, with the Business Insider article mentioning Samumed’s $12 billion valuation for alopecia and wrinkle drugs, none past Phase 2 clinical trials, plus others like Neon Therapeutics and Unity Biotechnology with sizable raises. So no more Theranoses…till the next time.

See here for the 34 previous TTA chapters in this Continuing, Consistently Amazing Saga.

The Theranos Story, ch. 34: It’s a conspiracy! It’s a vendetta!

click to enlargeUpdated Well, that is what one of her major investors says, and he would know! Just when we thought that a week would go by with not a peep about Theranos, we get three. Peeps, that is.

First, the Conspiracy Theory. This is being propounded by early Theranos investor Tim Draper of Silicon Valley VC Draper Fisher Jurvetson. It was all John Carreyrou’s ‘strange vendetta’ against her, to wit: “Elizabeth is the victim of a witch hunt.” The Wall Street Journal reporter set off a cascade of press coverage that compelled, nay, forced Federal regulators (FDA, CMS, SEC, DOJ) and state counterparts to go after Theranos and CEO Elizabeth Holmes. Mr Draper bluntly accused Mr Carreyrou of doing it for money; “the guy is getting $4 million to continue this charade”, referring to the advance on his book proposal “Bad Blood”. The most nauseating part of the Ars Technica interview is this mock-libertarian rejoinder from Mr Draper: “It’s the press creating a series of events that negatively impact technology, progress and our economy.”

So it was all a mistake, an illusion–there was nothing significantly wrong with the Edison Lab, or Theranos’ business practices! (Hat tip to Bill Oravecz of Stone Health Innovations)

Mr Draper perhaps did not consider that Mr Carreyrou’s reporting blew up the $100 million investment of the WSJ‘s owner, Rupert Murdoch (Ch. 27), not just DFJ’s. And SafewayWalgreens, Larry Ellison, Cox Enterprises, Bechtel Group….

Second, the belated reporting of deficiencies at the Scottsdale lab found by CMS (Centers for Medicare and Medicaid Services) on 29 September. According to the Wall Street Journal report (co-authored by Mr Carreyrou), “Theranos responded to the inspection findings in Arizona with a plan to correct its lab deficiencies, but the lab regulator in November rejected the plan and proposed sanctions for the Arizona lab as well.”  This preceded the closing of all labs and the ‘refocusing’ of Theranos on the miniLab. Their general counsel stated, “After months of careful consideration, and prior to CMS’s unannounced inspection in Arizona, Theranos decided to close its laboratories.” Usually, these CMS reports are issued after 90 days. Theranos is appealing the sanctions arising from the California lab inspection with an administrative law judge, which include lab license revocation and a two-year ban on Ms Holmes from blood-testing operations.

Third, Theranos announced an eight-person Technology Advisory Board (TAB) to be led by Dr. Channing Robertson and Howie Rosen. The academics, executives, and entrepreneurs will be charged with “reviewing specific Theranos technology initiatives associated with product development, design and deployment” as well as four other mandates. Analogies concerning horses, roads and the status of barn doors come to mind. Release.

And finally another Theranos Washington connection, besides new SecDef and ‘Warrior Monk’ James Mattis, now an alumnus. It seems that the vetting of Betsy DeVos, nominee for Secretary of the Department of Education, uncovered that she has an investment in Theranos of more than $1 million. However, the Office of Government Ethics also reported her whopping earnings of less than $201. Since others like Rupert Murdoch, Bechtel, Walgreens, Cox, and others ponied up $50 to $100 million, hers is a mere bag of shells by comparison. MedCityNews, who has dubbed it the ‘As Theranos Turns’ soap opera. Hat tip to Bill Oravecz of Stone Health Innovations.

See here for the 33 previous TTA chapters in this Continuing, Consistently Amazing Saga, including Arizona’s lawyering up for a prospective Theranos lawsuit (Ch. 33) the firing of 155 remaining staff (Ch. 32), the resignation of now-DOD Secretary General Mattis from the BOD (Ch. 31), and Theranos’ annus horribilis (Ch. 30).

The Theranos Story, ch. 33: Arizona gets its lawsuits on

click to enlargeThe state of Arizona is lawyering up to sue Theranos for consumer fraud. TechCrunch found a bid solicitation on Arizona’s state procurement website from the Office of the Arizona Attorney General (AGO). It requests bids for outside counsel to assist the AGO in legal action against Theranos for fraudulent blood testing. From the Outside Counsel RFP:

The purpose of this contract is to retain Outside Counsel to aid the Arizona Attorney General’s Office (the AGO) in commencing legal action against Theranos, Inc. and its closely related subsidiaries for violations of the Arizona Consumer Fraud Act arising out of Theranos Inc.’s long-running scheme of deceptive acts and misrepresentations relating to the capabilities and operation of Theranos blood testing equipment, including but not limited to deceptive acts and misrepresentations made to Arizona consumers in connection with Theranos Wellness Centers in Arizona and California. Upon retention, Outside Counsel will assist the AGO on a contingency fee basis per the terms set forth in this Request for Proposal.

Arizona’s involvement with Theranos went above and beyond ‘deceptive acts and misrepresentations’ made to Arizona consumers. As we noted last September in Chapter 20, in early 2015 lawmakers quickly deregulated blood testing to permit direct consumer order of blood tests, after Elizabeth Holmes and company swept in and turned the governor and legislators quite ga-ga. It turns out the unimpressed Arizona Medical Association was on the mark in their objections. So undoubtedly this first move by a state entity is Powered by Embarrassment.

One wonders which law firm out of their lengthening list Theranos will choose. (See Chapter 29) Bids are due by 27 Jan. Hat tip to Bill Oravecz of Stone Health Innovations.

See here for the 32 previous TTA chapters in this Continuing, Consistently Amazing Saga, including the firing of 155 remaining staff (Ch. 32), the resignation of General Mattis from the BOD (Ch. 31), and Theranos’ annus horribilis (Ch. 30).

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.

Walgreens partners with Chicago health tech incubator MATTER (US)

Walgreens, the US retail pharmacy part of Walgreens Boots Alliance, on 20 December announced its own alliance with Chicago healthcare incubator and innovation community, MATTER. This Editor believes it is the first retail partnership with a health tech-focused incubator or accelerator in the US; most of these partnerships are with angel networks, VCs, health system venture arms or large commercial healthcare partners such as Qualcomm, Allscripts or GE Healthcare. Walgreens’ contribution will be to mentor and collaborate with MATTER entrepreneurs. Reportedly they have or have had more than 150 startups in their program. They are also part of Chicago’s push to slice itself some health tech cake versus cities like San Diego, Palo Alto, Dallas, Boston and New York via the recently launched Health Care Council of Chicago (HC3), which was co-created by MATTER and Leavitt Partners. Hopefully, Walgreens will get some of their $140 million back via their Theranos lawsuit ending their blood testing misadventure [TTA 17 Nov, Ch. 24] and spread their bets with legitimately promising startups. Press release, ChicagoInno

Rock Health announces its Top 50 in digital health (US)

This Editor observes that digital health is at the state of maturity (so to speak) where entities assemble a Top 50 list and host a dinner to pass out awards. Rock Health, Fenwick & West, Goldman Sachs and Square 1 Bank cast a wide net from investment to startups in their just-released list. (Of course there will be a glitzy dinner, soon, at the kickoff of the JP Morgan Healthcare Conference, 9 – 12 January 2017 in San Francisco. Want an invite?)

Of great delight is an award to John Carreyrou of the Wall Street Journal as Reporter of the Year for his investigative work on Theranos. Other highlights are Validic (clinical/wellness data integrator) as Fastest Growing Company, Evolent Health for Best Performing IPO and BSX Technologies‘ LVL hydration monitor as Crowdfunding Hero (having raised $1.1 million when goal was $50,000). Rock Health website

What is increasingly curious to this Editor is that digital health companies, in nearly all cases, aren’t crossing borders and oceans. Every one seems to stick and be unique to its own country of origin, creatures of their own unique petri dish.

Also in other Rock Health news, having evolved a position as a venture fund/business support provider, they have added to their list of prominent partners kidney care and medical group operator DaVita. Rock Health release.

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. 27: investor ‘whales’ surface in class action lawsuit news

click to enlargeDon’t jump…you may land on one of them! In the Bottomless Well that is The Unicorn Losing Its Horn, The Transubstantiation of a $9 bn valuation to $9, to mix up a Whole Lotta Metaphors, the latest is that Certain Big Investors (‘whales’ in Vegas Lingo) and at least one minnow have lost their shirts, or maybe their sleeves and cuff links.

The first is via a class action lawsuit filed Monday against Theranos in San Francisco Federal Court by Hagens Berman Sobol Shapiro LLP, seeking to represent potentially hundreds of purchasers of Theranos shares from July 29, 2013, through October 5, 2016 .

According to the Wall Street Journal, the charges relate to “false and misleading claims about its operations and technology while soliciting money from investors.” Hagens Berman is representing Silicon Valley investment banker Robert Colman, who is the retired co-founder of Robertson Stephens & Co. (a legendary, now defunct, investment bank specializing in tech that blew up after the dot-com bust). He invested through a VC fund, Lucas Venture Group, who participated in Theranos’ Series G funding in late 2013. Lucas was invited to invest $15 million, and their principals had personal ties to Elizabeth Holmes, according to TechCrunch. The second plaintiff, Hilary Taubman-Dye, purchased Theranos shares at $19/share on SharesPost Inc., an online exchange for shares of private companies, in August 2015. Her claim is that she tried to cancel it after the Wall Street Journal exposé in October, but the purchase went through in December after Theranos, Elizabeth Holmes and an unidentified third party refused to buy back the shares as a secondary transaction. TechCrunch identified her as a “longtime technical recruiter who now works in investor relations for a TV production company” which means that her investment was likely no bag of shells for her. Their respective investments are not disclosed.

The second, according to a second article in the Journal, comes from the usual ‘sources familiar with the matter’ and papers filed by Theranos in Delaware and Arizona. These include some very atypical startup investors, such as Rupert Murdoch of News Corp. and family-controlled Cox Enterprises, at $100 million each in the 2014-15 round when shares were valued at $17/each, and an undisclosed amount by Riley Bechtel of Bechtel Group, who was later named to the board of directors. Other, more typical Silicon Valley investments date back to when Theranos was the more pedestrianly named Real Time Cures in 2004 and the shares were 15 cents each:

  • Oracle co-founder Larry Ellison
  • VCs from firms such as ATA Ventures and Draper Fisher Jurvetson. The latter’s Tim Draper and his daughter (!) have been quite critical of anyone, especially John Carreyrou of the WSJ, claiming that Ms Holmes was perhaps mistaken in her scientific and business practices. (Partner Jurvetson in reports has expressed a more ‘que será, será’ attitude.) (more…)

The Theranos Story, ch. 26: counsel Boies, Schiller & Flexner departs, disagreeing

click to enlargeAppearing in the netherworld of a Saturday weekend edition before a holiday week was this tidbit in the Wall Street Journal announcing that Theranos‘ legal representation will no longer be big, politically connected NY-based law firm Boies, Schiller & Flexner. Their replacement is a big, politically connected Washington, DC-based law firm, WilmerHale.

Reasons why, according to the John Carreyrou article, are disagreements on how to handle the ongoing multiple government investigations of Theranos. It also follows the September departure of in-house general counsel, and former Boies partner, Heather King, who is returning to the firm. Her replacement is David Taylor, who has no visible ties to WilmerHale.

According to Mr Carreyrou, Mr Boies “became Theranos’s outside counsel after being approached in 2011 by two investors in the Palo Alto, Calif., startup. He fiercely defended Theranos against questions about its technology and operations.” Those actions included threats of legal action against the WSJ and pressuring whistleblower Tyler Shultz (ch. 25).

Mr Boies also sits on the Theranos board. His fate there is not disclosed, yet.

David Boies is known as a bare-knucks litigator involved in high profile cases defending Sony, American Express and Big Tobacco, and against Medco, Microsoft and George Bush in the 2000 presidential election. At 75, the chairman is one of the best known figures in what is colorfully termed Big Law.

Perhaps another reason why is found at the end of the article. “The law firm was paid in Theranos stock for its work on the patent case, according to a person familiar with the matter. Boies Schiller was granted more than 300,000 shares valued at $4.5 million, based on a valuation of $15 a share at the time, this person said.” Since this $9 bn Unicorn is now worth about $9, this was a bad investment, indeed.

But Elizabeth Holmes, and whoever is left, are soldiering on to “show who we are through our inventions.” Indeed.

If the link hits the paywall, search on “Theranos and David Boies Cut Legal Ties”.  See here for the 25 previous TTA chapters in this Continuing Saga.

The Theranos Story, ch. 24: looking for the nadir in Walgreens’ lawsuit

click to enlargeWhen will we find the nadir of Theranos’ business practices? Between the excruciating details of the Walgreens lawsuit and the treatment of an employee who knew the truth in 2014 (part 2), the bottom, like Jacob’s Well in Texas at left, may be unfindable.

The first is what is revealed in the public version (filed 15 Nov) of the civil complaint filed with the US District Court, District of Delaware (PDF). While heavily redacted in parts of text and in the exhibits, it is damning if all true–and there is little available information that does not fit Walgreens‘ narrative, though this Editor was left wondering why red flags about Theranos didn’t flap ‘n’ fly at Walgreens much earlier, especially with a reported $140 million investment at stake.

The relationship began in January 2010. A March presentation by Theranos included some astonishing claims: the Theranos finger-stick blood draw lab analysis had been comprehensively validated by ten of the leading fifteen pharmaceutical companies over seven years; that bio-pharma companies, “prominent research institutions, and US and foreign government health and military organizations” had already used the technology; that Theranos was capable of launching it in retail stores by end of 2010. They also represented that they were positioned with FDA to introduce the technology outside of clinical studies. Johns Hopkins, contracted by Walgreens to validate their methodology, could only work with data provided by Theranos.

Did anyone at Walgreens think to check with said pharmas, researchers, government health and military organizations? There was time. The master agreement was not signed until 2012 and pilot stores opened in 2013.  (Pages 5-10, section 24 through 50). Interestingly, pages 11-12 which may deal with the labs, as well as many other parts, are heavily redacted.

In short, there is a gap of at least two years when Walgreens could have double-checked Theranos’ claims and methods, especially in the crucial period before pilot locations were opened. (To be fair, Theranos successfully maintained a veil of secrecy and a wall of PR smoke.) But the repercussions were huge.  It seems that Walgreens only woke up from the dream when the Wall Street Journal published its investigation another two years later in October 2015. In the immediate aftermath of the article, Walgreens learned that Theranos had abandoned the finger-stick draws…and that the head of the Newark CA lab was a full-time dermatologist onsite once a week (page 15).

After that point, the Theranos fan dance with Walgreens accelerates.

  • Theranos concealed the January and March 2016 CMS notices and subsequent reports on its labs to Walgreens until again the WSJ publicly revealed it (pages 17-18, 25). They also attempted to conceal the CMS rejection of the Plan of Correction for its labs (page 24).
  • Theranos accused Walgreens of breaching the agreement and confidentiality to the WSJ , and also cited delay in building out Wellness Centers–in February 2016 (pages 20-21)
  • Walgreens received nothing but evasions from Theranos including no notification of ‘tens of thousands’ voided results, including critical PT/INR coagulation results, until after the WSJ broke that bit of news on 18 May (page 26).

By 12 June 2016, the wheels were fully off (and the world was minding, indeed) and Walgreens called the breach of warranty. But even then, this was not until a final push–lawsuits were filed against both Theranos and Walgreens starting in late May.

One wonders how many reputations are on a stake (to mix two metaphors) at Walgreens Boots. Details in Ars Technica (which obtained the PDF and broke the story) and of course Neil Versel’s acerbic POV in MedCityNews. Hat tip to reader David Albert MD of AliveCor.

See here for the 23 previous TTA chapters in this Continuing Saga.

The Theranos Story, vol. 23: Walgreens drops the $140 million contract breach hammer

click to enlargeWalgreens Boots Alliance has finally sued Theranos in Delaware Federal Court in for breach of contract.  Walgreens is seeking $140 million, supposedly equivalent to their amount invested, according to sources cited in the Wall Street Journal article. Not many details are available, since Walgreens moved to seal the civil suit under their mutual non-disclosure agreement.

Allegations are flying, of course. Walgreens is officially mum, but according to the WSJ‘s ‘close to the matter’ sources, Walgreens claims that Theranos misled them about the state of their technology during their three-year partnership and even after the blood-draw centers were closed in June, which put their customers at risk. This sounds like the fraud and misrepresentation cited by Partner Fund Management, which moved in October to get its $96 million back like Lee Marvin as Walker in Point Blank. Earlier reports confirmed that patients did not learn for weeks or months, often not until forced to, that their Theranos test results were unreliable. There are reports that at least 10 patient lawsuits have been filed in Arizona and California.

(This Editor notes that their Theranos agita hasn’t soured Walgreens on funding health tech. They are a substantial investor in TytoCare, an all-in-one vital signs device with retail potential, and MedAvail, a kiosk dispenser for prescription and OTC medications)

Theranos has, no surprise, said a great deal, aggressively–the trademark of their legal supremo David Boies. They claim to be the aggrieved party: “Over the years, Walgreens consistently failed to meet its commitments to Theranos. Through its mishandling of our partnership and now this lawsuit, Walgreens has caused Theranos and its investors significant harm.” Theranos has exited the blood-testing business and is supposedly refocusing on developing technology to sell to outside labs. Also MedCityNews ‘coughs’, The Verge.  See here for the 22 previous TTA chapters.