Theranos, The Trial of Elizabeth Holmes, ch. 4: we deceive those who want to believe

The Theranos Cave apparently has no bottom. Reportedly at the halfway mark, Tuesday’s trial focused on the testimony of former Theranos product manager Daniel Edlin. Recommended by his college friend Christian Holmes in 2011, he soon stepped into frontline work, assembling presentations sent to investors such as Rupert Murdoch, conducting VIP tours with demonstrations of the Edison labs, coordinating with the press, and with Elizabeth Holmes, plumping for Department of Defense and pharmaceutical company business. 

According to Mr. Edlin’s testimony, Theranos executives and staff staged demos and blood tests for investors and VIPs. Sometimes the blood tests worked fine, sometimes they didn’t (as in Rupert Murdoch’s case). Investors and reporters often were more interested in seeing Edison and MiniLab machines “work” without seeing any test results. All routine for an early-stage technology company. What was not routine was that other test results others were “corrected” (for Walgreens executives), reference ranges changed, or tests removed on the direction of Dr. Daniel Young, a Theranos VP.  The MiniLab never was used for patient blood testing as it had trouble performing general chemistry or ELISA tests adequately.

Rupert Murdoch’s (listed as a witness) investor presentation binder was entered into evidence. According to CNBC, one section of the binder read: “Theranos offers tests with the highest level of accuracy.” Another section said the blood-testing technology “generates significantly higher integrity data than currently possible.” Mr. Edlin testified that Ms. Holmes vetted every investor deck and binder, including the ones shown to DOD. The website, overseen by Ms. Holmes, made statements such as “At Theranos we can perform all lab tests on a sample 1/1000 the size of a typical blood test.” However, even Theranos’ general counsel advised against using these superiority claims:

  • “Please remove reference to “all” tests and replace with statements such as “multiple” or “several.” It is highly unlikely that the laboratory can perform every conceivable test, both from a logistical standpoint and because the CLIA certification designates specific specialties of test the lab performs.
  • For a similar reason, replace “full range” with “broad range.”
  • Replace “highest quality” with “high quality”
  • What substantiation do you have for “have results to you and your doctor faster than previously possible?”
  • Remove “unrivaled accuracy.”

To be fair, some of this language did change over time. The defense, for instance, had a try at shifting blame to one of Theranos’ marketing agencies.

But overstatements were a way of ‘fake it till you make it’ life at Theranos. The infamous Fortune article (later retracted by the author), the glowing 8 September 2013 Wall Street Journal article by Joseph Rago made at the time of the Walgreens pilot were felt to be overstatements by Theranos insiders, but never corrected. Walgreens and Safeway executives previously testified that they were told that Theranos devices were in use in Army medical evacuation units. But the truth was, according to Mr. Edlin who managed the DOD relationship, that AFRICOM (US Army African Command) deployed the Edison device in Cameroon, Uganda, and South Sudan to run as an experiment to test the viability of the machine. It was never deployed in the Middle East (CENTCOM). The Edison 4.0 was deemed too heavy and put off until lighter-weight units were developed. Nonetheless, Theranos received a 12-month service contract. 

The prosecution strategy here is to show that Ms. Holmes was hands-on when it came to marketing and investor communications, approved the overstated claims, and was not “controlled” by Sunny Balwani as the defense maintains. If anything, he deferred to her. 

CNN Business, KTVU Fox 2 running commentary, Daily Mail, California News Times  Unfortunately, the Mercury News, Bloomberg, and WSJ are paywalled.

TTA’s earlier coverage: Chapter 3, Chapter 2, Chapter 1

To be continued….

TTA’s Autumn Falls #3: Theranos cost Safeway, Walgreens $520M; Walgreens buys majority of VillageMD, CareCentrix: Babylon, Devoted Health, Lark’s big raises–more!

 

 

 

Weekly Update

Editor’s Note: We’re looking for contributors–if interested, email Editor Donna

The Trial reveals Walgreens’ and Safeway’s frustrations and deceptions with Theranos that ultimately cost them a collective $520 million. Walgreens learned its lesson, bringing home the primary and post-acute care of VillageMD and CareCentrix. Babylon raises even more $, Best Buy moves into home care management with Edinburgh’s Current Health. And stepping back, is telehealth now due for a correction?

Short takes: Walgreens now majority share of VillageMD, CareCentrix; Lark Health lifts $100M, UnitedHealth Group’s profitable Q3 and Change delay
What’s next for telehealth? Is it time for a correction? (Maybe not as much as we cracked it up to be)
News and deal roundup: Babylon’s $200M raise, Best Buy buys Current Health, Virgin Pulse-Welltok, Devoted Health’s $1bn raise, Withings watch gains FDA ECG clearance
Theranos, The Trial of Elizabeth Holmes, ch. 3: Safeway, Walgreens execs testify to deception, frustration with Holmes, failed pilots and labs (updated) (Expensive lessons!)

The trial of Theranos founder Elizabeth Holmes moves to the Hot Grill, with the former lab director turning slowly on the spit to ‘well-done’. Babylon Health is finally SPAC-ing–and buying US practices. And in TelehealthWorld, both Teladoc and Babylon are offering similar virtual full-service primary care to payers and employers for members.

Telehealth’s primary care wars heat up: Teladoc’s Primary360, Babylon 360 (Telehealth ain’t beanbag)

Babylon Health’s SPAC closing later this month at $4.2 billion value, buys California medical practices (Now to turn that red ink to black)
Theranos, The Trial of Elizabeth Holmes, ch. 2: the lab director’s contradictions, competence questioned (The best defense that money can buy)
 

The trial of Theranos founder Elizabeth Holmes slugfests on, with prosecution hammering away at knowing malpractice in patient care with the Edison labs, and the defense using every Perry Mason-like trick in the book to break witnesses. And back in the real world, Walgreens continues to explore outside of Drug Store World with a rumored pass at management services company Evolent Health.

Theranos, The Trial of Elizabeth Holmes: ch. 1 (The defense lawyers must have been paid in advance)
Walgreens may acquire Evolent Health: report (Possible reach into tech-based management services)

Google continues shedding Health initiatives with shutdown of NHS’ Streams clinical support app. But is health care too much for Big Tech accustomed to monetizing clicks and ads? Headspace and Ginger decide to merge rather than be bought, as digimental health stays hot. Beth Israel Deaconess shows how hospital IT can get its skates on with telehealth. And Cerner’s pay package for its new CEO shows you that crime does not pay, but healthcare certainly does!

Mental health apps Headspace, Ginger to merge into $3B Headspace Health (Better to merge than to be bought? The sprint of digital mental health continues.)
Another Google termination: Google Streams clinical support app used by NHS (Another broken healthcare toy)
Amazon’s Chime telehealth solution rang Beth Israel Deaconess Medical Center’s bells–case study (How hospital IT can innovate under pressure)
Is healthcare too much for Big Tech’s Google and Apple? Look at the track record. And David Feinberg’s $34M Cerner package. (Too much, too soon?)

Our weekend lead news is Google Health’s shutdown, with its head graduating to the Big Job at Cerner. Rockley Photonics may be revolutionizing the smartwatch with its photonic vitals sensors. Sharecare expands health ed and enters the once-sleepy home care biz. Humana also bets big on home care with Kindred, SDOH heats up, Maven’s a unicorn, and Carrots are on the healthcare plate with the trimmings.

Breaking: Google Health shutting down, most employees scattered to other divisions (And its head is now Cerner CEO)
Deal and news roundup: Humana closes $5.7B Kindred at Home buy, Unite Us SDOH buys Carrot Health for data, Carrot Fertility raises $75M, Maven Clinic at $1B value, Privia partners with Babyscripts for moms, Tyto Care and Prisma Health
Sharecare expands health education capabilities, acquires CareLinx home care for $65M (updated) (A healthcare conglomerate in the making?)
Comprehensive “clinic-on-the-wrist” digital health sensor system debuts. Apple Watch of future? (UK/US) (Rockley Photonics’ big leap)

The news isn’t taking a Summer Holiday, neither are deals. Honor just rocked the sleepy home care world with its buy of Home Instead. UnitedHealth will have to wait till end of year for Change. Morgan Health debuts with $50M in Vera Health. The Telehealth Teeter-Totter continues with Amwell’s gloomy forecast, Teladoc’s Aetna deal. And Voices Carry with stress testing and a neuroprothesis that may give communication back to those who cannot speak. 

Home care rocked: Honor Technology acquires home care provider Home Instead (It’s all about the caregivers and hospital-at-home)
News roundup: update on UnitedHealth/Change Healthcare DOJ check, Tunstall adds new CTO, Amwell’s gloomy second half, Teladoc’s Aetna deal, Fitbit and LifeScan diabetes
Hearing voices: Cigna-Ellipsis AI-powered voice stress test; UCSF/Weill neuroprosthesis decodes attempted speech (Giving speech to the speechless in the future)
News and funding roundup: patient outreachers Relatient, Radix merge; health apps top 350,000; Morgan’s $50M in Vera Health; Communicare247, Doro, TeleAlarm join Scottish Digital Telecare’s list

Have a job to fill? Seeking a position? Free listings available to match our Readers with the right opportunities. Email Editor Donna.


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Telehealth & Telecare Aware: covering the news on latest developments in telecare, telehealth, telemedicine, and health tech, worldwide–thoughtfully and from the view of fellow professionals

Thanks for asking for update emails. Please tell your colleagues about this news service and, if you have relevant information to share with the rest of the world, please let me know.

Donna Cusano, Editor In Chief
donna.cusano@telecareaware.com

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Short takes: Walgreens now majority share of VillageMD, CareCentrix; Lark Health lifts $100M, UnitedHealth Group’s profitable Q3 and Change delay

Walgreens has ‘gone big’ with its VillageMD primary care practice investment, putting on the table $5.2 billion. It’s now t the majority owner with 63% of the company, up from 30% last year. Their projected number of co-located full-service Village Medical practices is projected to grow to 600 by 2025, up from a current 52. VillageMD is still planning an IPO in 2022, making for a potential great ROI for Walgreens. Walgreens Boots Alliance also invested $330 million in CareCentrix, a post-acute and home care provider, for 55% of the company. CareCentrix was a recent investor in Vesta Healthcare [TTA 9 April]. Wrapping it all up is their new Walgreens Health, for tech-enabled consumer-directed primary care, post-acute care, and home care.

Weight loss and chronic conditions app Lark Health flew into a $100 million Series D, led by Deerfield Management Company, with PFM Health Sciences and returning investors Franklin Templeton, King River Capital, Castlepeak, IPD, Olive Tree Capital, and Marvell Technology co-founder Weili Dai. Their total funding since 2011 is over $195 million (Crunchbase). Lark claims an AI-based platform for individual coaching in weight loss along with related conditions such as diabetes, pre-diabetes, diabetes prevention, cardiovascular, and behavioral health. The platform logs and provides immediate feedback on food and tracks data from sources like Apple Health. The new funds will be used for R&D and to expand its virtual care integrations to more payers. Current payer partnerships include Anthem, Highmark BCBS, and Medical Mutual. Release, MedCityNews, FierceHealthcare

UnitedHealth Group, parent of UnitedHealthcare and Optum, reported $4.1 billion in profit for Q3, notching $72.3 billion in revenue for the quarter, a tidy gain over year prior’s $65.1 billion. The mega-acquisition of Change Healthcare to fold into OptumInsight is further delayed, being worked towards a closing of early 2022, having hit more than a few strong regulatory headwinds and the rocks of DOJ [TTA 14 Aug].  Becker’s Payer Issues, FierceHealthcare 

Theranos, The Trial of Elizabeth Holmes, ch. 3: Safeway, Walgreens execs testify to deception, frustration with Holmes, failed pilots and labs (updated)

It’s Tuesday, and it’s another court day in Silicon Valley’s Big Trial, this time with the former C-level executives of Safeway and Walgreens who did the partner deals with Theranos–and rued the days Elizabeth Holmes walked in their doors. Updated for additional Tuesday testimony reports.

Former Safeway (supermarket) CEO Steve Burd returned to the stand for more prosecution questions and a turn with the defense. Mr. Burd had formed Safeway Health to introduce Theranos in 2010, after Ms. Holmes personally negotiated a deal with Safeway without attorneys. Ms. Holmes definitely wove a spell on Mr. Burd. “There are very few people I had met in the business that I would actually say are charismatic. She was charismatic, she was very smart, and she was doing one of the hardest things you can do in a business, and that’s to create an enterprise from scratch.” Always decisive, ‘she owned the room’.

From that point, and after an unusually high 100 hours of due diligence (updated, ArsTechnica 13 Oct), it was full speed ahead. But the potholes turned up fast after Ms. Holmes had convinced Safeway to invest in the company, claiming that they could run 95% of tests on one cartridge and that they could handle the volume from hundreds of store testing sites. During a pitch to the Safeway board, board member Michael Shannon offered his blood draw for a PSA test, the screening test for prostate cancer. The Theranos Edison machine “made a bunch of noise,” but never delivered a result, even after Ms. Holmes said something about getting it later (updated, ArsTechnica 13 Oct).

By the time the pilot started with regular blood draws, from the testimony, “there were results that didn’t make any sense. Samples were lost and samples were not properly cooled. He also said tests took days to come back when other companies could deliver in 24 hours. In an email to Holmes, Burd wrote: “I am genuinely concerned that Safeway’s lab reputation gets worse by the day.” By 2012, Safeway had built out 98% of 960 planned stores to hold Theranos testing sites, but had long since blown past the $30 million estimate. Multiple launch dates were missed over two years. By November 12, Mr. Burd had reached the end of his tether. “I can only recall having been discouraged once in the last 62 years. That said, I am getting close to my second event. ” and “This does not feel like a partnership, I’ve never been more frustrated.”

Theranos never rolled out to the public with Safeway. Mr. Burd retired from Safeway after a long career in May 2013.

Apparently the defense cross conducted by Kevin Downey is concentrating on The Big Chance that Safeway took with Theranos, after all a ‘startup’ that never built out their technology for consumer use, and all the regulatory hurdles the company faced. Mr. Burd confirmed it but he and the board reviewed the agreement and included requirements such as a CLIA waiver to operate the lab devices, negotiating preferred network status with commercial health plans, and a network of partners. Most of all, Safeway negotiated the right to terminate the agreement if the pilot failed and Theranos did not obtain FDA clearance. On the redirect, the government maintains that Theranos started in 2003 and purported to be making money (!!).

Up next for the prosecution was Wade Miquelon, former CFO of Walgreens. Walgreens was the only Theranos partner to put Theranos centers in their store. He testified to the presentation he received in 2010 which was similar to those received by investors. It included claims that Theranos’ technology could “run comprehensive blood tests” from a finger stick in real time and that it had partnerships with major pharmaceutical companies and military organizations–some of which were semi-true, the rest fictional. Apparently, some of the validation reports from pharmaceutical companies were false–while they had logos, there was one from Schering-Plough where its name was misspelled and never noticed by anyone at Walgreens. The prosecution had already established to the jury in opening arguments on 8 September that the Pfizer report endorsing the technology had also been faked. It had been written by Theranos, with a Pfizer logo added. 

Mr. Miquelon testified that he was never told that third-party labs were being used.“My understanding is, the blood would be tested on the [Theranos] Edison device,” adding later, “My understanding was that the base level testing would be able to do 96 percent of the testing done at labs.” He stated that third-party testing would be to check calibrations and accuracy. Relying on such testing would be beside the point of cost and time savings. 

Mr. Miquelon’s testimony will continue on Wednesday.

KTVU2’s coverage is nearly all tweets so it’s assembling a picture from many fragments. Ars Technica on Mr. BurdUpdated: Additional information on Mr. Miquelon: Fortune, Washington Post

Walgreens sued Theranos in 2016 for $160 million invested [TTA 9 Nov 2016]. The company was one of the few able to claw back substantial funds, a paltry $25 million, in August 2017. Safeway settled in June 2017 for an undisclosed amount. They had built out 800 centers and cost the company $360 million before the agreement was axed (updated for cost, ArsTechnica 13 Oct).

If you have access to the WSJ, their coverage details a trail of forged documents, massive fundraising–and losses, and partner deception. The NY Times ran an interesting ‘color’ article on the atmosphere in the San Jose courtroom. The trial is settling into a groove. Two court artists (complete with art) have interesting impressions of Ms. Holmes and the participants. The spectators appear to be primarily retirees with the time to line up for the 34 seats in the courtroom and 50 in an overflow room, though the testimony goes over the head of many. Ms. Holmes’ family and partner accompany her daily. And two jurors have departed, one a Buddhist who became uncomfortable with the idea of punishing Ms. Holmes. Judge Davila has already extended trial hours one hour to get through the stack of witnesses a little faster.

Our previous coverage: Chapter 1, Chapter 2

To be continued….

Is healthcare too much for Big Tech’s Google and Apple? Look at the track record. And David Feinberg’s $34M Cerner package.

With Google scattering Google Health to the four winds of the organization--the heck with what employees recruited for Health think of being reorg’d to, say, Maps or YouTube and falling through the corporate rabbit hole–more detail has leaked of Apple’s struggles. This time, on the scaleback list (a/k/a chopping block) is Health Habit. It’s an app in the Apple Store that connects users with AC Wellness, a doctor’s group in Cupertino, California. The ‘eligible participants’ are restricted to Apple employees. From the app site, they can check weight, nutrition, blood pressure, and schedule wellness checks. It seems to be the typical ‘skunk works’ project that’s not ready for prime time, but its public fate seems to be poorly timed and simultaneously, overblown because they are–well–Apple

Bottom line, is healthcare once again proving rather resistant to being leveraged by technological solutions? Those of us who go back to the Stone Age of health tech, or those of us who joined in the Iron and Bronze Ages, remember when you couldn’t get into a conference cocktail party without a “wellness” app. (You say you’re in behavioral and remote patient monitoring for older adults? Oh, look! A squirrel!)

Microsoft was going to dominate consumer health with their HealthVault for personal health records (PHRs). We know how that turned out–dead apps, Fitbit an also-ran bought, Pebble and Misfit going to the drawer of failed toys, Jawbone t-boning plus Intel and Basis written off in 2017, and HealthVault unlamentedly put out with the trash at the end of 2019. Oh yes, there was an earlier Google Health for PHRs, which died with a whimper back in 2012 or so.

The press releases crow about Big Tech’s mastery of complexity, yet going off on their own without partners–or even with partners–never seems to work. In the industry, it makes for a few good articles and the usual rocket launching at places like Forbes, but the pros tend to treat it with a shrug and pull out a competitive plan. Glen Tullman, founder of Livongo who will never have to worry about paying for chateaubriand for two for the next billion years or so, stated the obvious when he said that patients cared about the overall experience, not the tech.

Speaking of experience, Amazon Care promises the best for its employees and enterprise accounts–a one-minute telehealth connection, a mobile clinician if needed within the hour, and drugs at the door in two hours. All with direct pay. This has met with skepticism from telehealth giants like Teladoc and Amwell with established corporate bases. There’s also CVS Health and Walgreens. The Editor has opined that care isn’t Amazon’s game at all–it’s accumulating and owning national healthcare data on Amazon Care and Pharmacy users that is far more valuable than whatever is spent on providing care and services [TTA 16 June]. Will Amazon really be able to pull it off?

Paddy Padmanabhan, the author of Healthcare Digital Transformation, lists a few more reasons It’s Too Hard For Big Tech In Healthcare in his HealthcareITNews article here….

  • Healthcare is a part-time job for Big Tech
  • Big tech firms want to solve the healthcare problem by themselves
  • Selling technology is not the same as selling healthcare services

…but holds out some hope that the initial success of “digital-first and virtual-first providers of healthcare emerging as challengers” will point the way for them.

And speaking of Google Health and former employees, Cerner’s necessary SEC disclosure today of new CEO and president David Feinberg, MD’s compensation package was sure to create some talk in Googleville among his now-scattered team. $34.5 million over the next 15 months is structured as follows:

  • $900,000 base salary
  • a target cash bonus of $1.35 million
  • a one-time cash bonus of $375,000 stock
  • $13.5 million in Cerner’s restricted shares for 2022
  • $3.375 million in stock shares for the fourth quarter of 2021
  • a new hire award of $15 million in restricted stock shares to offset his equity loss with Google. 

Whew! Becker’s HealthIT

News roundup: AliveCor’s latest FDA clearance plus antitrust vs. Apple, VRI on the market, Walgreens’ ‘tech-enabled future’ indefinite plus VillageMD status, monthly telehealth usage drops 12.5%

AliveCor disclosed its latest FDA 510(k) clearance for the KardiaMobile 6L, for calculation of patients’ QTc interval by the patient remotely or in the office with a physician or other clinician. QTc interval is, for those of us who aren’t cardiologists, is the total time from ventricular depolarization to complete repolarization. If too long (prolongation) or too short (congenital short) for the heart rate, it can indicate a dangerous ventricular arrhythmia or atrial or ventricular fibrillation. The manual measurement takes 30 seconds. AliveCor also has clearance on software (InstantQT) that measures QT intervals quickly and accurately to detect potentially dangerous QT prolongations in patients. Prolongations can be triggered by medications including anti-arrythmia drugs, anti-fungals, antibiotics, and some psychiatric drugs. AliveCor release. In other recent news, in June they acquired CardioLabs, a monitoring and cardiac diagnostic service provider based in Tennessee, to expand their clinical servies. Release.  

And in David Sues Goliath–Again–News, AliveCor also filed, in that quiet week right before Memorial Day, a Federal antitrust suit in the Northern District of California. This lawsuit is over Apple’s exclusion of other heartrate analysis providers from the Apple Watch, harming AliveCor and consumers, and seeks damages plus an injunction to cease the exclusion. Release  This is in addition to their US International Trade Commission (ITC) complaint on infringement of AliveCor patents held for heart monitoring on the Apple Watch 4, 5, and 6. That seeks to bar importation of Apple Watches [TTA 29 Apr]. No update on that so far. 

‘Insider’ report: VRI on the market. PERS Insider, our newly discovered source for news about the emergency response device market, reported on 22 June that VRI, a PERS and remote patient monitoring provider, is up for sale. It has been majority-owned by Pamlico Capital, a private equity company, since 2014. VRI does not sell direct to consumer but concentrates on health insurance, government programs, and other B2B through its dealer network. No reasons for sale given, but with all things telehealth and most things remote healthtech fetching hefty sums post-pandemic, perhaps Pamlico senses a fortuitous time to test the waters for an exit. Article. (Subscribe here to their weekly free letter)

Walgreens Boots Alliance’s new CEO promises a ‘tech-enabled’ future for the chain, sans details. The incoming CEO, Rosalind Brewer, fresh from her COO position at Starbucks, on WBA’s Q3 earnings call mentioned a buildout of a “previously communicated tech-enabled healthcare initiative” but no further information, as still reviewing the company. Stefano Pessina has retired from the long-held CEO position, but retains the executive chair title in addition to being WBA’s largest individual shareholder. Forbes’ breathless report. More to the profit point, the latest on Walgreens and VillageMD’s full-service Village Medical practices at Walgreens locations: 29 new locations in Houston, Austin and El Paso, Texas this year, staying on track for 600 primary care practices in more than 30 markets over next four years. Business Wire

National telehealth usage dips to 4.9% of US claims in April, a 12.5% drop from March. Analyzing regional and national insurance claims data, non-profit health analytics company FAIR Health in its monthly report tracks telehealth receding as patients return to in-person care. Telehealth is now dominated by mental health procedure codes, accounting for 58.65% of diagnoses, with all other conditions at 3% or lower. Regionally, the Northeast is even higher at 64.2% and the Midwest above 69%. Monthly National report, Monthly Regional Tracker page

Telehealth usage going flat, off by 1/3 and declining: Trilliant Health study

Trilliant Health, a healthcare data analytics and advisory shop based in Tennessee, has run some projections on the US healthcare market and telehealth, and they’re not as bright as many of us–and a lot of investors plus Mr. Market–have believed. It opens up on page 4 of the electronic document (also available in PDF) with this ‘downer’–that the largest sector of the largest global economy is overbuilt and unsustainable. Hospitals and health systems have operated for decades that basic economic factors–demand, supply, and yield–don’t apply, and there are more companies competing with them for the consumer healthcare dollar than they realize–with more proliferating every day. 

Sledding through their 160-page report, we turn to our sweet spot, telehealth, and Trilliant is not delivering cheerful news (pages 32-43). 

  • Unsurprisingly, demand for telehealth is tapering off. Based on claims data for face-to-face video visits, excluding Medicare fee-for-service (Original Medicare) and self-pay visits, they peaked above 12 million in April 2020 and, save for a bump up in December 2020-January 2021, steadily declined to about 9 million by March 2021.
  • Teladoc, the leading provider, is projecting that 2021 volume will only represent 4 percent of the US population–a lot more than before, but not growing as it did in 2020.
  • Telehealth’s growth was astronomical on both coasts–California, Massachusetts, Vermont, Oregon–and Hawaii–but relatively lower in middle and Southern America in places like Wyoming, North Dakota, Mississippi, and Iowa. Telehealth usage is declining sharply in that region as well but across the board in all states including California. In fact, Phoenix and Dallas had higher telehealth utilization pre-pandemic than during it.
  • Mental health drove telehealth growth during the pandemic, representing 35 percent of claims, almost four times the next group of categories at 8 percent. The largest group of diagnoses were for anxiety and depression among women 20-49. With the reopening of the US economy and children heading back to school, will this sustain or decline?
  • Women 30-39 are the largest users of telehealth–pre, during, and post-pandemic

Telehealth is not only proliferating, it is going up against now-open urgent care, retail clinics from Walgreens, Walmart, and CVS, plus tech-enabled providers that blend virtual care with home care, such as Amazon with a full rollout of Amazon Care and other employers. The cost of care is also a negative driver. FierceHealthcare analyzes other parts of the report impacting practices, health systems, and hospitals.

 

Disruption or giveaway: Amazon Care signs on employers, but who? Amazon Pharmacy’s 6 months of meds for $6. (updated)

Is this disruption, a giveaway, or blue smoke requiring IFR? An Amazon Care VP, Babak Parviz, said at the Wall Street Journal’s Tech Health virtual event that all is well with their rollout of virtual primary care (VPC). Washington state is first, with VPC now available nationally to all Amazon employees as well as companies. However, Mr. Parviz did not disclose the signed-up companies, nor a timetable for when in-person Amazon Care practices will be expanding to Washington, DC, Baltimore, and other cities in the coming months.

Mr. Parviz also provided some details of what Amazon Care would ultimately look like:

  • Clinician chat/video connected within 60 seconds
  • If an in-person visit is required, a mobile clinician arrives within 60 minutes, who can perform some diagnostic tests, such as for strep throat, provide vaccinations and draw blood for lab work. For other diagnoses, that clinician is equipped with a kit with devices to monitor vital signs which are live-streamed to remote clinicians.
  • Medication delivery within 120 minutes

FierceHealthcare

The timing of the Amazon Care rollout has not changed since our coverage of their announcement in March. This Editor noted in that article that Credit Suisse in their overview was underwhelmed by Amazon Care as well as other efforts in the complex and crowded healthcare space. Amazon Care also doesn’t integrate with payers. It’s payment upfront, then the patient files a claim with their insurer.

Existing players are already established in large chunks of what Amazon wants to own.

  • Both Amwell’s Ido Schoenberg [TTA 2 April] and Teladoc’s Jason Gorevic (FierceHealthcare 12 May) have opined that they are way ahead of Amazon both in corporate affiliations and comprehensive solutions. Examples: Amwell’s recently announced upgrade of their clinician platform and adding platforms for in-home hospital-grade care [TTA 29 Apr], Teladoc’s moves into mental health with myStrength [TTA 14 May].
  • Even Walmart is getting into telehealth with their purchase of a small player, MeMD [TTA 8 May].
  • CVS has their MinuteClinics affiliated with leading local health systems, and Walgreens is building out 500 free-standing VillageMD locations [TTA 4 Dec 20]. CVS and Walgreens are also fully integrated with payers and pharmacy benefit management plans (PBM).

Another loss leader is pharmacy. Amazon is also offering to Prime members a pharmacy prescription savings benefit: six-month supplies of select medications for $6. The conditions are that members must pay out-of-pocket (no insurance), they must have the six-month prescription from their provider, and the medication must be both available and eligible on Amazon Pharmacy. Medications included are for high blood pressure, diabetes, and more. The timing is interesting as Walmart also announced a few days earlier a similar program for Walmart+ members. Mobihealthnews.

crystal-ballThis Editor’s opinion is that Amazon’s business plans for both entities and in healthcare are really about accumulating data, not user revenue, and are certainly not altruistic no matter what they say. Amazon will accumulate and own national healthcare data on Amazon Care and Pharmacy users far more valuable than whatever is spent on providing care and services. Amazon will not only use it internally for cross-selling, but can monetize the data to pharmaceutical companies, payers, developers, and other commercial third parties in and ex-US. Shouldn’t privacy advocates be concerned, as this isn’t being disclosed? 

Walmart Health moves into the hot telehealth area with MeMD buy

Retail giant Walmart’s health arm, Walmart Health, has agreed to purchase privately held telehealth provider MeMD. MeMD provides telehealth services in primary care, urgent care, women’s/men’s health, and mental health services to both individuals and organizations for their employees. Neither purchase price nor executive leadership transitions were disclosed. The transaction, which requires regulatory approval, is expected to close in the next few months.

The relatively low profile MeMD was founded in 2010 by ER physician and entrepreneur John Shufeldt, MD. The company is headquartered in Scottsdale, Arizona, and offers national coverage for its five million members.

A big move that indicates a strategic wobbliness? Walmart Health’s strategy has been a roller coaster over the past few years. Aggressively starting out of the gate in 2018 with high-profile exec Sean Slovenski leading and plans to open up 1,000 clinics, they retrenched in 2020 with his departure and slowed down the opening of Walmart Health locations. Virtual visits, which are merchandisable in-store and online, signal a different direction that may be easier to scale than brick-and-mortar locations, and have proven their market. Meanwhile, back at the stores, last month Walmart announced a partnership with Ro to put its trendy Roman men’s sexual health and vitamin product lines into 4,600+ Walmart stores starting 1 May. RetailBrew 

Looming in the background, of course, is CVS with their MinuteClinics, Walgreens with 500 free-standing VillageMD locations [TTA 4 Dec 20], and Amazon rolling out Amazon Care nationally. Walmart’s employees have used Doctor on Demand’s services, with the company dropping the visit cost to $4 during the pandemic. With the Grand Rounds merger [TTA 18 Mar], this may have been another reason for Walmart to bring in-house a telehealth provider. Who may be feeling the most heat from Walmart’s and Amazon’s moves? Teladoc and Amwell. Walmart release, Becker’s Hospital Review, Engadget

The Theranos Story, ch. 66: Walgreens and Safeway aren’t investors, they’re business partners!

The difference is not hair-splitting in the defense effort to have charges tossed. In Federal District Court on Tuesday (6 October) in San Jose, Elizabeth Holmes’ defense made the case to Judge Edward Davila on dismissing some of the prosecution’s charges against her. As petitioned in late August, the defense maintains that two of the entities, Walgreens Boots and Safeway (a Western regional supermarket chain), were unfairly classified as investors versus ‘business partners’. As investors, the prosecution could charge Holmes with fraud crimes with a longer statute of limitations. If they were to be classified as business partners and ‘transactions’, while there were crimes committed, the statute of limitations has expired.

The prosecution’s rebuttal is that Walgreens and Safeway could be considered as both investors and partners. The defense response was that the government took too much time to file the charges and failed to get the proper consent, which may be the hair that splits the ability of the prosecution to use these charges.

Let’s look back at both companies’ involvement with Theranos

  • Walgreens reportedly invested over $140 million in Theranos. This consisted of direct funding (a $40 million loan convertible into equity), and an “innovation fund’ designed to fund the rollout of Theranos Wellness Centers in Walgreens US locations starting in 2013. Walgreens filed suit against Theranos in November 2016 to recoup that investment based on breach of contract, after civil lawsuits were filed against them jointly, halted development, and settled for $25 to 30 million in late July 2017 when Theranos assets were dwindling to barely breathing status [TTA 3 Aug 17]. More details on their Partnership from Hell are recapped here from the 2016 lawsuit.
  • Safeway’s involvement as the exclusive supermarket partner was planned to be even more extensive. Their 2012 deal was $350 million for building 800 clinic locations in Safeway stores. This was dropped in November 2015 [TTA 20 Nov 15], around the same time as Walgreens halted the expansion of the Theranos Centers. According to reports at the time, Safeway had already built out the 800 locations, later repurposing them for flu shots and similar. Direct investment was estimated at $10 million (WSJ). Safeway settled with Theranos for $30 million in June 2017. 

The publicly available history shows that both funded Theranos directly in addition to being business partners. Both took substantial additional risk investments from building out facilities to showcase Theranos’ services for their customers. Both settled civilly for amounts far below the fair recoupment of their investment.

While this sounds like legal nitpicking, the defense strategy, in this Editor’s layperson’s calculation, is to erode the number of charges against Holmes and their seriousness so that her inevitable sentence becomes lighter. Another move in this vein is the mental defect defense [TTA 18 Sept] alleging Holmes’ psychic inability to discern right from wrong in her business dealings. Start with something over the top like ‘insanity defense lite’, and then chip away at the rest of the charges. Fox Business, Mercury News

News roundup: Amwell’s socko IPO raises $742M, Walmart and the Clinic Wars, Taskforce on Telehealth Policy report released, Israel’s Essence releases fall detection sensor system

Telehealth bullishness shows no sign of diminishing. On Wednesday, Amwell‘s (the former American Well) IPO stunned markets by not only debuting at $18 per share (a price only large investors received) but also opening at $25.51 on the NYSE (AMWL) and floating more than 41 million shares for a raise of $742 million. If underwriters exercise all their options, the raise could exceed $850 million. Only last week, the SEC filing projected a sale of 35 million shares at $14 to $16 a share. Back in August, the raise was estimated to be only about $100 million. (One could consider this a prime example of ‘sandbagging’.) Friday closed at $23.02 in a week where Mr. Market had a lot of IPOs and hammered traditional tech stocks. As reported earlier, Amwell is backed by Google via a private placement and also Teva Pharmaceutical.

Smaller and lower profile than Teladoc, Amwell provides services for 55 health plans, 36,000 employers, and in 150 of the nation’s largest health systems, with an estimated 80 million covered lives. Like Teladoc, Amwell has yet to be profitable, with 2019 losses of $88 million and $52 million in 2018. FierceHealthcare, Marketwatch. Meanwhile, the Teladoc acquisition of Livongo has gone quiet, as is usual.

The Clinic Wars continue. Another front in the consumer health wars (and repurposing retail) is more, bigger, better clinics onsite. CVS drew first blood early this year with the expansion of MinuteClinics into fuller-service HealthHUBs, with a goal of 1,500 by end of 2021. Walgreens flanked them with 500 to 700 Village Medical full-service offices [TTA 9 July]. In this context, the expansion of Walmart Health locations looks limp, with their goal of 22 locations in Georgia, Florida, Arkansas, and Chicago metro by end of 2021. Another concern is with scale and modularizing the Walmart Health locations’ construction via constructor BLOX,  One wonders with recently reported layoffs of 1,000 at corporate and the replacement of industry innovation veteran Sean Slovenski with Lori Flees, whether there’s some radical rethinking of their clinic business investment as not mass but targeted to underserved areas that avoid CVS and Walgreens. FierceHealthcare, Walmart blog  CVS also announced the doubling of their drive-thru COVID-19 testing sites to 4,000 by mid-October. FierceHealthcare

More Weekend Reading. Here in the US, the Taskforce on Telehealth Policy, a joint effort between the National Committee for Quality Assurance (NCQA), the Alliance for Connected Careand the American Telemedicine Association, has issued a report that focuses on maintaining quality care, fitting telehealth into value-based care models, enforcing HIPAA for patient privacy, and ensuring widespread and equitable access to broadband and technology. The involvement of the NCQA is a major step forward in advancing policy in this area. Press release/summary, Report page, Powerpoint slides, and webinar recording  Hat tip to Gina Cella for the ATA.

New entrant in passive fall detection. Israel’s Essence SmartCare is launching MDsense, a multi-dimensional fall detection solution for the residential market. It is sensor-based, using wall mounted intelligent sensors rather than wearable devices that statistically are not worn about half of the time and have their own well-documented performance concerns. The release also mentions it can differentiate between multiple persons and pets, which this veteran of QuietCare would like to see. MDSense is part of Essence’s Care@Home system which uses AI and machine learning to continuously collect actionable data to respond to fall events and manage care better towards improved outcomes.

The Theranos Story, ch. 61: Elizabeth Holmes as legal deadbeat

Did her lawyers expect otherwise? This weekend’s news of Elizabeth Holmes’ legal team at Cooley LLP withdrawing their representation services due to non-payment should not have caused much surprise. Cooley’s attorney team petitioned the court to withdraw from the case, stating that “Ms. Holmes has not paid Cooley for any of its work as her counsel of record in this action for more than a year.”

Cooley was representing Ms. Holmes in a class-action civil suit in Phoenix brought against her, former Theranos president Sunny Balwani, and Walgreens, charging fraud and medical battery. (When they withdraw, will she seek public representation based on poverty?)

Perhaps Ms. Holmes is the one who’s setting priorities, as the civil suit would be for monetary damages, and no money means there will be none for the plaintiffs to collect. The DOJ charges are a different story. She is on the hook for nine counts of wire fraud and two counts of conspiracy related to her actions at Theranos. Conviction on these could send her to Club Fed for 20 years plus a fine of $250,000 plus restitution for each charge. [TTA 16 June]

Last Wednesday, both Ms. Holmes and lawyers for her and Mr. Balwani were in Federal court in San Jose on the wire fraud and conspiracy charges, demanding that the government release documents from the Food and Drug Administration (FDA) and the Centers for Medicare and Medicaid Services (CMS) that allegedly would clear them. After an hour, Judge Davila set 4 November as the next hearing date. 

Defending oneself does not come cheap, but after your company’s value crashes to $0 from $9bn, one might be looking for change in your Roche-Bobois couch and wondering if your little black Silicon Valley-entrepreneur formal pantsuit/white shirt ensembles will last through the trial. CNBC 2 Oct, CNBC 4 OctFox Business, Business Insider

DNA-based personalized food choices to prevent Type 2 diabetes onset in test with Imperial College, London and Waitrose (UK)

Can DNA analysis and an app help prevent Type 2 diabetes onset in the pre-diabetic? The problem of preventing Type 2 diabetes in people determined to be pre-diabetic is multi-factorial, but one approach is diet to control 1) obesity and 2) improve glucose regulation. DnaNudge, which has developed a DNA analysis from a cheek swab, is being used in a clinical trial conducted by Imperial College London’s NIHR (National Institute for Health Research) Imperial Clinical Research Facility to determine whether DnaNudge’s scanner and app, used while shopping at Waitrose & Partners stores, can prevent the development of Type 2 diabetes in prone individuals.

To this Editor’s knowledge, this is the first time that personalized DNA testing and an app have been used in conjunction with retail food choices.

[grow_thumb image=”https://telecareaware.com/wp-content/uploads/2018/10/MyDNA-Report-Sample.png” thumb_width=”125″ /][grow_thumb image=”https://telecareaware.com/wp-content/uploads/2018/10/product-feedback-recommended.png” thumb_width=”150″ /]How it works is that the individual’s DNA is analyzed first and then used to match what food choices are best for that person via a simple thumbs up or down indicator on the app. 

  • Using a sterile cotton swab, users sweep the inside of their cheek to capture a sample of saliva.
  • The swab is inserted in a processing cartridge plugged into the DnaNudgeBox, a small instant DNA analyzer
  • The analysis of specific genetic traits related to nutrition is completed in minutes and uploaded to the DnaNudge app on the smartphone via a wearable ‘capsule’, the DnaBand (left #1)
  • The wearer then can scan individual food items as that person shops, receiving the ‘thumbs up’ for good choices and ‘thumbs down’ for ones not so good, with alternatives suggested for the latter (left #2)

The 12-month clinical trial was launched last week, with Waitrose contacting customers in the North London area with information on how to take part. Professor Nick Oliver from Imperial College London, who is leading the clinical study at the NIHR Imperial Clinical Research Facility, stated in the release: “This key trial with DnaNudge allows us – for the very first time – to study in detail the outcomes of DNA-personalised food choices for pre-diabetic individuals, and to explore whether this type of accessible technology can deliver a proactive and sustainable solution to managing nutrition, and preventing the development of Type 2 diabetes in people at highest risk of this long-term condition.” It is not clear from the release whether there’s further information provided on the food choices or other education.

DnaNudge was co-founded by Regius Professor Professor of Engineering at Imperial College London Chris Toumazou and published geneticist and leukemia researcher Dr. Maria Karvela. Waitrose has staked out a healthy food position with the introduction of 100 Healthy Eating Specialists, shop floor specialists who direct customers who ask towards healthier choices. This tie-in is interesting, and if it works, this Editor can see it in use in a CVS-Aetna test or Walgreens, as both have edged into food retailing in many locations, albeit with not many apparent healthy choices, unless one considers Milky Ways fine food.

The Theranos Story, ch. 55: ‘Bad Blood’s’ altered reality on ‘Mad Money’; it was all Bad Blitzscaling

[grow_thumb image=”https://telecareaware.com/wp-content/uploads/2018/07/Rock-1-crop-2.jpg” thumb_width=”150″ /]

She lied and the lies got bigger and bigger and eventually the lies got so big relative to reality that it became a pretty massive fraud. 

The hyperbolic Jim Cramer of CNBC’s ‘Mad Money’ settled down for a chat with John Carreyrou, the author of ‘Bad Blood’, to dissect what Mr. Cramer touted as ‘the best business book since Phil Knight’s book about starting Nike, ‘Shoe Dog”. Mr. Carreyrou outlines Elizabeth Holmes and Sunny Balwani went ‘live’ with fingerstick tests far too prematurely, burned through money, lied to the board, and (schadenfreude alert!) lied to attack dog David Boies, her attorney. There was also a real lack of ‘due diligence’–real diligence–on the part of companies like Safeway and Walgreens. A reveal coming out of this interview is that Walgreens hired a lab consultant, Kevin Hunter, as early as 2010, who ‘smelled a rat’ even then–and Walgreens executives ignored him, frightened that Ms. Holmes would go to CVS. Wrapping Ms. Inexplicable Me up, Mr. Carreyrou attributes her mindset to ‘noble cause corruption’; she really did believe that her blood testing machine would do good because the outcome would be good for society. Thus every corner cut was justified….which explains a lot, but really excuses nothing. The ten-minute video is over at ValueWalk (the transcript is only partial).

LinkedIn’s hyperbolic co-founder Reid Hoffman, like him or not, does have a way with words, and this article in Fast Company is a decent discussion of a new term that he actually coined, ‘blitzscaling’ which is pursuing rapid growth by prioritizing speed over efficiency in the face of uncertainty. It’s quite a lure he sets out to his classes at Stanford, that the only way to have a successful business in winner-take-all (or most) markets is to do this, and if you do it right you’ll have the next Google, completely ignoring the fact that 99.99 percent of businesses don’t need to change the world, just to get to breakeven, get to profitability, and endure (or get bought out). He springboards off this to where Ms. Holmes and Mr. Balwani Went All Wrong. The answer? Product failure=Mortal Risk–to the patient. They needed to meet a Walgreens deadline thus went out prematurely with their nanotainer testing knowing it did not work. The best quote in the article?

There’s a big difference between being embarrassed and being indicted.

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

[grow_thumb image=”https://telecareaware.com/wp-content/uploads/2016/11/jacobs-well-texas-woe1.jpg” thumb_width=”150″ /]The other shoe drops into this bottomless well. If Elizabeth Holmes and Sunny Balwani thought that the March SEC action [TTA 15 Mar] would be it, they were misinformed. Today, the Department of Justice, US Attorney’s Office for the Northern District of California, charged them with two counts of conspiracy to commit wire fraud and nine counts of wire fraud. According to CNBC, they were arraigned in US District Court in San Jose Friday morning. Both were released on $500,000 bond each and ordered to surrender their passports. Holmes’ parents appeared with her in court.

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

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

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

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

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

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

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

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

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

[grow_thumb image=”https://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…)