The Theranos Story, ch. 54: cue up ‘Tainted Love’ in the courtroom

[grow_thumb image=”http://telecareaware.com/wp-content/uploads/2018/07/Rock-1-crop-2.jpg” thumb_width=”150″ /]Tainted Love, Labs, and Lucre Indeed. Drop the needle on the Gloria Jones version from 1964 or the Soft Cell version from 1981.

Consider that the very fates of Ms. Elizabeth Holmes, the now not-so-Sunny Balwani, and the formerly $9 bn Unicorn Theranos may hinge on the nature of their personal relationship and its influence on the governance of the company.

There are two legal actions against the company and the two principals, one by the DOJ for criminal fraud [TTA 16 June] and by the SEC on (civil) securities fraud [TTA 15 March].  Both are out on $500,000 bail on the DOJ charges. The possibilities on the latter can be up to 20 years in Club Fed, plus $250,000 in fines and clawing back of investor funds, if any can be found.

While Ms. Holmes settled with the SEC, paying a fine and exiting the company, Mr. Balwani did not and is fighting the charges, though this declaration was made before the DOJ charges.

Bloomberg Markets brings up an interesting set of dynamics which can play well with potential jurors and make the prosecution’s case far more convincing for a Northern California jury. To wit, in 2009 when she started running out of money, Ms. Holmes turned to Mr. Balwani, her boyfriend, for a $12 million line of credit. In return, he became president and COO. The nature of their relationship was kept strictly hush-hush to the board and investors. Secrecy was ratcheted up at the company and management started to break down. And the timing: a week after Mr. Balwani left, the news of bad patient test results and problems with their lab started to break big.

Jurors, even in Silicon Valley, love drama and personal intrigue–especially the type that underscores deception and $900 million in fraud perpetrated by a Stanford dropout who clumsily attempted to channel Saint Jobs and a somewhat schlubby dude who Should Have Known Better. Far more than gullible corporate suits at Walgreens and hedge funds….add to it the personal stories of patients harmed by bad Theranos tests and you get an emotional story worthy of Law & Order.

Do expect Ms. Holmes to bring up her Saint Joan if not a female Saint Sebastian analogy. Burning at the stake versus being shot full of arrows are too memorable images which she’ll try out. Add a #MeToo spin of a young woman coerced by an older man–a tale of at least tit-for-tat to get the $12 million. 

The rompin’ soap opera is likely to start next year. Stay tuned…. 

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

[grow_thumb image=”http://telecareaware.com/wp-content/uploads/2018/07/holmes-barbie-doll-1.jpg” thumb_width=”125″ /]A 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. 49: CEO Holmes reportedly raising funds for a new company–and feeling like Joan of Arc

[grow_thumb image=”http://telecareaware.com/wp-content/uploads/2016/11/jacobs-well-texas-woe1.jpg” thumb_width=”150″ /]Here’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. 48: down to 24 employees in a last ditch before bankruptcy

[grow_thumb image=”http://telecareaware.com/wp-content/uploads/2016/04/Yak_52__G-CBSS_FLAT_SPIN.jpg” thumb_width=”150″ /]The ground is next. Theranos is down to its last two dozen employees or less, in a bid to buy a few more months of time before bankruptcy, according to a breaking report in the Wall Street Journal.

The announcement was made by Elizabeth Holmes Tuesday to approximately 125 remaining employees at its downscale Newark, California headquarters. (This Editor wonders if she wore a black turtleneck.) Interestingly, Ms. Holmes remains CEO after settling civil charges with the Securities and Exchange Commission (SEC) while a criminal investigation continues out of the US Attorney’s office in San Francisco. 

The WSJ article from the estimable John Carreyrou (who deserves an old-school Pulitzer Prize for his investigative reporting) recaps Theranos’ fall for those who need it. But…there’s more. Theranos received only $65 million of $100 million promised in their last (ditch) funding from Fortress Investment Group late last year, revealed by Ms. Holmes in an investor email this past Tuesday. The remainder is contingent on Theranos achieving an FDA Zika blood test approval using their miniLab. She stated that this test is still having problems and appealed to investors for yet more funding. The layoffs were designed to keep their cash reserve over $3 million until the end of July, below which Fortress is entitled to seize Theranos’ assets and liquidate them. This, as we have previously noted, is Fortress’ specialty–as now fan dancing is Ms. Holmes’.

According to Mr. Carreyrou’s sources, Ms. Holmes is still living large in basic black. “Until Tuesday, Ms. Holmes still had two personal assistants and two security guards who drove her around in a black Cadillac Escalade SUV, according to the people familiar with the matter.” This Editor wonders what happened after Tuesday. Public transit? A used car for a few thousand?

Theranos and the $900 million in lost investment may have also put a wet blanket on 2017 health tech funding, based on what we’ve learned in Rock Health’s report [TTA 5 Apr]. Other companies with real advances and promise may be paying the price for Theranos’ hype and fakery.

Our 47 past chapters and other Theranos mentions are for your perusal in our pages here

The Theranos Story, ch. 47: the post-mortem, blaming–and ghost chasing–begin

[grow_thumb image=”http://telecareaware.com/wp-content/uploads/2016/04/Yak_52__G-CBSS_FLAT_SPIN.jpg” thumb_width=”150″ /]Now that Elizabeth Holmes is the former CEO of Theranos, many of the publications who huzzahed their ‘revolutionary’ blood testing system three short years ago are publishing their post-mortem analyses, often of how the wool was pulled over their eyes.

Jenny Gold from Kaiser Health News and NPR has a short ‘alarming’ tale of her press visit in November 2014 to a Theranos testing site at a Palo Alto Walgreens for an NPR feature. At Walgreens, she spoke with patients on the record and was invited to witness their blood draw–not the finger prick Theranos (and Walgreens) promoted, but a standard volume blood draw. After multiple and telling upset reactions from her company press handlers, including demanding Ms. Gold erase her audio recording (!) and accusing her of harassment, alarms went off at the Walgreens store for a non-existent fire. She was baited with an interview with Ms. Holmes–which never happened–and wound up with a corporate attorney instead who made unsupported statements. Ms. Gold canceled her story, which if she tracked the bad smell would have been likely the first press shot across the bow. What this post-mortem tells us is the extent of the coverup and the sheer (and unethical) fawning flackery that appeared in places like the New Yorker, Forbes, Inc., and Fortune.  NPR

The FT further digs into our gullibility, our wanting to believe that someone in a black turtleneck could put the Big Labs out of business,  how we in the press hungered for a new and female Steve Jobs to shake up the status quo. Andrew Hill: “Trouble often hits, though, when leaders stick to their story after it has diverged from reality, swerving into embellishment, mythmaking and, in Ms Holmes’s case, apparently fraud.”

But we were no smarter than those who gave Ms. Holmes and Mr. Ramesh ‘Sunny’ Balwani $700 million in Mad Money. (more…)

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

[grow_thumb image=”http://telecareaware.com/wp-content/uploads/2016/11/jacobs-well-texas-woe1.jpg” thumb_width=”150″ /]Our 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. 44: Walgreens settles lawsuit, cash box empties further

[grow_thumb image=”http://telecareaware.com/wp-content/uploads/2016/11/jacobs-well-texas-woe1.jpg” thumb_width=”150″ /]Walgreens realizes Theranos’ funds are not bottomless. Confirming the June Wall Street Journal report [TTA 26 June] that Theranos had advised its investors of a negotiated settlement with Walgreens Boots Alliance, Tuesday’s announcement offered few specifics. According to the Theranos release, the settlement resolves all claims by Walgreens and dismisses the lawsuit, with no finding or implication of liability. Terms were not formally disclosed, but sources told the WSJ (FoxBusiness) that the settlement was over $25 million. In June, it was estimated to be less than $30 million, so the over/under wasn’t very wide. Payment timing was not disclosed.

As we noted in June, Walgreens had invested an estimated $140 million between direct funding (a $40 million loan convertible into equity), and an “innovation fund’ designed to fund the store location rollout. The lawsuit filed last November was intended to recoup that amount. The thorn that Walgreens and its attorneys grasped was that even with insurance, there was not $140 million left in Theranos and nothing of equivalent non-cash interest. As a public company, certainly the realization that putting $25 million on the books this year was better than nothing. It is also likely that $110+ million has already been written off.

Not much left in Theranos’ till, other than some dollar bills and coins. In June, Theranos disclosed that their cash on hand was $54 million with a monthly burn of $10 million, leaving as of today $44 million. Even if the Walgreens settlement is covered 100 percent by insurance, at best Theranos has about four months of life–if nothing extraordinary happens. There are also ongoing SEC and DOJ investigations, plus the Colman/Taubman-Dye suit in California, which may result in more fines and settlements.

While Theranos makes much of its new management structure and commercializing new technologies (of which there is no word), there are no signs that beyond recapitalization earlier this year that there is fresh investment. Reports indicate they are trying, at long last, to exit real estate they no longer need–subleasing their expansive (and expensive) Palo Alto headquarters and relocating to their former lab in an industrial park in less tony Newark, California. As this Editor concluded in June, it is increasingly difficult to see a future for Theranos without Chapters 11 or 7 in it. It is rapidly arriving at a familiar place for startups, but not former Unicorns: Flat Brokedom.

Meanwhile, Walgreens Boots Alliance, barely dented in the exchequer, has closed on a $1.4 bn joint investment with KKR for institutional pharmacy company PharMerica. Drug Store News

The Theranos Story, ch. 43: Walgreens settles, $54 M in cash draining away

[grow_thumb image=”http://telecareaware.com/wp-content/uploads/2016/11/jacobs-well-texas-woe1.jpg” thumb_width=”150″ /]While your Editor was on leave last week, it appears that Theranos may have grasped the thorn of Walgreens Boots Alliance’s lawsuit and settled. The Wall Street Journal (subscriber access only, largely reported on Fox Business) reported that Theranos told investors of a tentative settlement with Walgreens for less than $30 million. 

Walgreens’ lawsuit, filed last year, was intended to recoup their $140 million investment in the company and store location payments. It surprised many observers that Walgreens would be content with 21 cents returned for every dollar of its investment, but since the original contribution took place over several years from 2010, much of this has likely been written down on Walgreens’ books as adjustments for bad debt. 

But this seeming win for Theranos further rips the veil off their dire financial situation. Theranos also told investors recently that it is down to $54 million in cash, according to the WSJ/Fox Business. This is much reduced from their last report of $150 million in March [ch. 41]. With a monthly burn of $10 million a month, this would leave $120-130 million if the March estimate was correct. Part of the settlements, including Walgreens, may be covered by insurance policies. However, what has transpired since then may further account for the discrepancy.

  • In May, Theranos settled with Partner Fund Management (PFM) for an undisclosed amount which WSJ sources estimated at $40-50 million. They sought to claw back their $96 million investment. (more…)

Breaking-The Theranos Story, ch. 41: settling, not fighting, with Partners Fund on fraud

[grow_thumb image=”http://telecareaware.com/wp-content/uploads/2017/04/The-big-dig.jpg” thumb_width=”150″ /]Breaking News and Updated. Settled–but not settled? Theranos’ May Day celebration was an announcement of a settlement with investor Partner Fund Management (PFM) LP on their two lawsuits alleging investor fraud. PFM’s funds had invested $96.1 million in Theranos’ February 2014 funding round. The amount and terms of the settlement were, as usual, not disclosed.

PFM’s original filing in Delaware Chancery Court in October claiming fraud on various representations that Theranos had made, such as 98 percent reliability on its small sample Edison labs. The second filing in April [Ch. 40] temporarily blocked Theranos’ added equity offer to investors, an offer which had the important condition of blocking further legal action once accepted [Ch. 38]. PFM had powerful and damaging evidence on its side from 22 deposed former employees and directors to bolster its allegations of investor fraud, which was revealed in snippets from unsealed documents last week.

This settlement, according to reports, ends both court actions and permits Theranos to continue their equity offer to investors. According to Theranos, 99 percent of investors were willing to accept it, which neatly heads off additional legal actions. The offer to C-1 and C-2 investors expires 15 May. Theranos release.

Yet the depositions obtained in this case appear to have taken on a life of their own. Digging down into the WSJ report (not yet paywalled if you go in through the ‘What people are talking about’ right-hand sidebar on LinkedIn, or if you have a subscription) is the interesting tidbit that “Federal investigators have obtained depositions taken in the Partner Fund litigation, including those of former Theranos employees and directors, according to a person familiar with the matter.” The WSJ also filed to have the depositions unsealed on Monday (1 May), which an outside entity can request under the rules of the Delaware Chancery Court even after a case is closed.

Despite settlements with PFM, the state of Arizona, and CMS, Theranos still faces a live investigation from the Securities and Exchange Commission (SEC) and the Justice Department (DOJ). There are also major lawsuits from Walgreens Boots seeking to recoup its $140 million investment (and remove the egg on their corporate face) and the Colman/Taubman-Dye suit in California. The latter action has the potential to become a much larger lawsuit, as the US District Court in Northern California has requested a show-cause from the plaintiffs on including third-party sellers (Lucas Venture Group, Celadon Technology Fund, SharePost) as defendants. It also personally charges Elizabeth Holmes and former CEO Ramesh ‘Sunny’ Balwani (ch. 39).

Time and money are running out–and with a Federal investigation in the mix, the future of Theranos still resembles our picture above.

  • In March, Theranos reported $150 million in cash holdings. With another settlement, how much is left in the bank?
  • That equity offer, expiring in two weeks, may be a moot maneuver. After investors do the math and look at the calendar, they may decide that legal action may be a better way of capturing whatever’s left, before it’s all gone or tied up in Chapter 11. Perhaps PFM is smart indeed in moving to settle early.
  • Federal investigations usually do not end happily, unless you are Mayor De Blasio of NYC. Who knows what high-powered maneuvering is going on behind the scenes to prevent Ms. Holmes’ black turtleneck from becoming orange? And where in the world is co-defendant ‘Sunny’ Balwani?

Additional coverage: TechCrunch, Bloomberg  Our index of Theranos coverage is here.

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

[grow_thumb image=”http://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. 22: the human cost of lab error (updated)

[grow_thumb image=”http://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. 17: closing the barn door after the horse

[grow_thumb image=”http://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=”http://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=”http://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…)

Theranos–the drama and examination continues

The latest chapters:

Theranos’ boards–the advisory board chock full of Blast From The Past political figures like George Shultz, Sam Nunn, Bill Frist and Henry Kissinger–and a governing board–are standing by CEO/founder Elizabeth Holmes. Of course, they have essentially no choice, because Ms Holmes utterly and completely controls the company in the Silicon Valley Manner. The governing board, split off from the advisory board after The Troubles started last October–consists of Ms. Holmes, COO Sunny Balwani, Riley Bechtel of the eponymous construction firm, retired Marine Corps General James “Warrior Monk” Mattis and David Boies, prominently featured in both articles below. Mr Boies is politically well wired and the kind of attorney you call in when you are facing Big Trouble and need Big Defense–or Offense. These boards of course bear responsibility for the governance of the company, including fiduciary, and the actions being taken by CMS, the US Attorney’s office in San Francisco and the Securities and Exchange Commission (SEC) may be making for some sleepless nights. New York Times, Vanity Fair (which overlaps the NYT article)

Trust But Verify is the extraordinarily apt ‘eyebrow’ on this ‘rise and fall’ Quartz article reviewing l’affaire Theranos by a professor of medicine at Dartmouth College. For the non-scientists among us, it gives a layman’s explanation on why venous blood for most tests is needed versus fingerpricks (the latter mixes blood and tissue fluid, and doesn’t accurately measure large molecules such as proteins and lipids–but fine for the smaller blood glucose molecules, as testing diabetics know). It also touches on the Icahn Institute/Mount Sinai study [TTA 26 April, see comment] and points to the Smoking Gun of boards largely not constituted of those with medical or biochemical expertise.

Update: Bloomberg explores a POV in an opinion piece that blood tests are inherently variable, and only one factor in a proper diagnosis. Theranos’ promises to run multiple blood tests on a tiny quantity of blood are not only suspect but also that the “assumption that succeeding in this quest would improve public health” is specious indeed. Theranos and the Blood Testing Delusion

The stakes are high, and getting higher, for Ms Holmes, indeed.

[Ed. Donna’s comment below our earlier article, Theranos’ triple whammy: CMS, DOJ and SEC, addresses some concerns our Readers may have about our coverage. While we are a website interpreting the news and the Editors generally refer to multiple published sources in an article to supply various points of view, we also express our opinions. We try our level best to be fair, to stay in good humor and buttress our points. When you the Reader has a point to add, differs with our interpretation, or believes that your Editors are hanging too far out on that swaying limb, please feel free to comment. We do have a Comments policy which isn’t onerous…it’s posted here.]

Theranos’ triple whammy: CMS, DOJ and SEC

[grow_thumb image=”http://telecareaware.com/wp-content/uploads/2015/11/shockedshocked.jpg” thumb_width=”150″ /] Shocked, shocked! Theranos CEO Elizabeth Holmes is a bit more wide-eyed than ever. On the popular morning (breakfast=UK) program Today, interviewed by the oddly ‘browed Maria Shriver and sans the usual Steve Jobs-channeling black turtleneck, she stated she was ‘devastated’ that they didn’t catch the lab testing issues faster. On CNBC, she was mildly defiant and justifying:

“I know what we’ve built and I know what we’ve created and I know what it means to people and it is a change that needs to happen in the world”

(Yes, it does mean a lot to people when their test results are wrong or not reliable. And the disappointment of those of us who’d like simple, less expensive testing that works.)

Last week CMS proposed (but not yet imposed) sanctions that include banning Ms Holmes and president Sunny Balwani from running or owning labs for two years, and removing licenses from Theranos’ labs in Newark and Palo Alto California. Wall Street Journal. The effect would be to remove them from the company. Yesterday, Federal prosecutors started the process of discovery by subpoenaing Walgreens Boots Alliance, their former customer, and the New York State Department of Health seeking broad information on how Theranos described its technologies to gain Walgreens’ business and NYS licensure. That information may also have misled government officials.

The third whammy is the Securities and Exchange Commission (SEC) looking into a parallel claim–that deceptive claims were made to investors.  No one at the above organizations is commenting to the Wall Street Journal, which broke the story earlier this year. While the company has $700 million in the bank, the famed $9 billion Unicorn Valuation is moving towards $9.

Ed. note: If the WSJ articles are paywalled, search on the headlines “Regulators Propose Banning Theranos Founder Elizabeth Holmes for at Least Two Years” and “Theranos Is Subject of Criminal Probe by U.S.” to get around them. Alternatively, see TechCrunch and MedCityNews, which is playing the World’s Smallest Violin about this.