Health tech founder ousted over alleged ‘acts of intimidation, abuse, and mistrust’: some reflections (Soapbox)

May 3, 2018 | by

And we thought they were par for the course. Those of us who have worked for company founders, CEOs, and senior execs have learned that some interesting personalities come with the territory, especially in entrepreneurial companies. This Editor has worked for at least one diagnosed ADHD, a bipolar ADHD, another with anger management/impulse control issues, and a gentleman who is now spending a few years in a Federal penitentiary for securities fraud. One of her most memorable CEOs made the cover of Fortune with the caption, “Is this America’s Toughest Boss?” and no, his name was not Donald Trump. (Clue: he was chairman of what was for a time the world’s largest airline conglomerate.)

Of late, there’s been the behavioral quirks of their founders leading to disastrous problems at Uber, Theranos, and Zenefits. It often seems that the more hype, the more sunshine, daisies, puppy dogs, mission, and ‘fab culture’ are on the website, the worse the dysfunctional reality and mistreatment of the troops.

Perhaps no longer. Monday’s very public firing by his board of Ron Gutman, CEO of HealthTap, a digital health all-over-the-map company that now has settled into a members-only patient-doctor mobile health platform, over non-financial behavior may be a first. Mr. Gutman was given the heave-ho by his board after, notably, months of effort. Recode cited a termination letter to him that he “committed acts of intimidation, abuse, and mistrust, and that [he] repeatedly mistreated, threatened, harassed and verbally abused employees.” The coup de grâce: “The toxicity you introduced into the workplace ends now.”

An all-hands memo to employees was more restrained:

After receiving concerning reports by employees about Ron’s conduct as CEO, the Board of Directors hired an outside law firm to conduct an investigation into these allegations. What we learned left us with no choice but to make this change, and we did so after taking the necessary steps from a corporate governance perspective.

The replacing CEO is Bill Gossman, a serial founder and a partner in one of the investors, Mohr Davidow Ventures.

Mr. Gutman has denied it all, stating that he did not abuse employees and that the VCs are in violation of their duties. (FYI, not a whiff here of #MeToo antics.)

Funded to the tune of $38 million by Khosla Ventures, Mayfield Fund, and Eric Schmidt’s Innovation Endeavors, but without fresh funding in five years, the public face of both Mr. Gutman and HealthTap (of which he is the very public face, appearing all over their website still) is one with a very large smile. Mr. Gutman gained some fame from his TED talk and book on the power of smiling. One wonders how the smile is doing today. A frown turned upside down. TechCrunch, Mobihealthnews

Soapbox: JPM’s Dimon takes the 50,000 foot view on the JP Morgan Chase-Berkshire Hathaway-Amazon health joint venture

April 10, 2018 | by

Mr. Jamie Dimon, the chairman and CEO of JP Morgan Chase, had a few thoughts about the JPM-Berkshire Hathaway-Amazon healthcare JV for all three companies. You’ll have to fill up the tea or coffee mug (make it a small pot) for it’s an exceedingly prolix Annual Shareholder Letter you’ll have to sled through to find those comments. Your Editor has taken her punishment to find them, towards the end of the letter in ‘Public Policy’. 

They demonstrate what this Editor suspected–an headache-inducing mix of generalities and overreach, versus starting modestly and over-delivering.

  • Point #1 sets up what has gone wrong. Among several, “Our nation’s healthcare costs are twice the amount per person compared with most developed nations.” Under point 2 on how poor public policy happened, an admission that Obamacare fixed little:

Here’s another example: We all know that the U.S. healthcare system needs to be reformed. Many have advocated getting on the path to universal healthcare for all Americans. The creation of Obamacare, while a step in the right moral direction, was not well done. America has 290 million people who have insurance — 180 million through private enterprise and 110 million through Medicare and Medicaid. Obamacare slightly expanded both and created exchanges that insure 10 million people. But it did very little to fix our broken healthcare system and has, in fact, torn up the body politic over 10 years — and this tumult may go on for another 10 years.

  • Point #7 is about fixing the deficit and the ill effects if we don’t. In Mr. Dimon’s view, healthcare is a major part of this through the uncontrolled growth of entitlements, with Medicare, Medicaid and Social Security leading the pack–skipping over the fact that nearly all Americans pay into Medicare and SSI well in advance of any entitlement collection. Healthcare is also an offender through unnecessary costs such as administrative and fraud (25-40 percent),  and six mainly chronic conditions accounting for 75 percent of spending.
  • The experts–specifically, their experts–will fix it! “While we don’t know the exact fix to this problem, we do know the process that will help us fix it. We need to form a bipartisan group of experts whose direct charge is to fix our healthcare system. I am convinced that this can be done, and if done properly, it will actually improve the outcomes and satisfaction of all American citizens.”
  • The generalities continue with
    • The JV “will help improve the satisfaction of our healthcare services for our employees (that could be in terms of costs and outcomes) and possibly help inform public policy for the country.” 
    • Aligning incentives systemwide ‘because we’re getting what we incentivize’
    • “Studying the extraordinary amount of money spent on waste, administration and fraud costs.”
    • “Empowering employees to make better choices and have the best options available by owning their own healthcare data with access to excellent telemedicine options, where more consumer-driven health initiatives can help.”
    • “Developing better wellness programs, particularly around obesity and smoking — they account for approximately 25% of chronic diseases (e.g., cancer, stroke, heart disease and depression).”
    • “Determining why costly and specialized medicine and pharmaceuticals are frequently over- and under-utilized.”
    • “Examining the extraordinary amount of money spent on end-of-life care, often unwanted.”
    • “To attack these issues, we will be using top management, big data, virtual technology, better customer engagement and the improved creation of customer choice (high deductibles have barely worked”).

This Editor has observed from the vantage of the health tech, analytics, payer, and care model businesses that nearly every company has addressed or is addressing all these concerns. So what’s new here? Perhaps the scale, but will they tap into the knowledge base those businesses represent or reinvent the wheel? 

A bad sign is Mr. Dimon’s inclusion of ‘end of life care’. This last point is a prime example of overreach–how many of the JV’s employees are in this situation? The ‘attack’ tactics? We’ve seen, heard, and many of us have been part of similar efforts.

Prediction: This JV may be stuck at the 50,000 foot view. It will take a long time, if ever, to descend and produce the concrete, broadly applicable results that it eagerly promises to its million-plus employees, much less the polity. 

PARO: The robotic therapy seal that benefits so few

March 29, 2018 | by

[grow_thumb image=”https://telecareaware.com/wp-content/uploads/2018/03/paro1jpg.jpg.size-custom-crop.1086×0.jpg” thumb_width=”150″ /]I have a problem with that cute, robotic seal cub PARO.

More accurately, I have a problem with the ethics of the business model of the Japanese company that makes it, Intelligent System Co. Ltd.

PARO started development in 1993 and the first English press release was in 2004 – a year before Telehealth and Telecare Aware started! Since then the indications that PARO is good for people with dementia have been building and building, as Editor Donna most recently highlighted in this item: PARO therapy robot tested, cleared by NHS for — hygiene.

I have no problem believing, as Donna summarised, “the research has shown that it lowers stress and anxiety, promotes social interaction, facilitates emotional expression, and improves mood and speech fluency.”

However, in response to an enquiry last week, it was confirmed to me that neither price or delivery time information is available but that PARO seals continue to be made individually, by hand. This is a huge production bottleneck and cost.

It is entirely proper for a company that produces handmade cars to have high prices and long waiting lists for their rich man’s toys but I am completely at a loss to conjure up any justification to apply that thinking to PARO. (PARO cost $6,400 in 2017.)

I believe that the insistence that PARO continues to be made in this way is an unethical denial of a benefit to millions of people.

Does Intelligent System not have the will or the skill to scale up production and bring down the cost so that every care home or dementia ward could acquire a PARO (or even a ‘PARO lite’) within a few years? If not, they should license it to a company that can.

At least they should stop pretending that PARO is benefiting people with dementia when it reaches so few.

This Telehealth and Telecare Aware Soapbox item is the personal opinion of TTA founder and Editor Emeritus Steve Hards.

Blockchains, EHRs, roadblocks and baby steps

March 12, 2018 | by | 3 Comments

TTA founder and former editor Steve Hards crawls out of his retirement tent to squint at the misty landscape of blockchain technology.

In a recent dream I was observing an auditorium full of people chanting “Blockchain! Blockchain! Blockchain!” and yes, mantra-like, blockchain is now popping up all the time in health technology articles and presentations.

It has taken a while to get to this stage. It was January 2016 when Editor-in-Chief Donna first mentioned blockchain. Since then there appears to have been more talk than action.

A year ago, in February 2017, health IT guru Brian Ahier was able to say in a comment here “Blockchain of course, is going to sneak up on a lot of people…”

Where we have seen developments occurring is in the trickle of ‘coins’ or ‘tokens’ in health-related Initial Coin Offerings (ICOs) of dubious investment worthiness. I may rant about those in a follow-up article if anyone is interested. (Let me know in a comment.)

The terminology is still in its ‘shakedown phase’ (see this great terminology rant) and, because of the publicity around Bitcoin, which is on a blockchain, the distinction between blockchains and distributed ledger databases is blurred. There are technical differences: blockchains are a sub-set of distributed ledgers (Wikipedia), which is the term I’ll generally use in this article.

Distributed ledgers and EHRs

What are the implications of distributed ledgers for the biggest databases in healthcare, electronic health records (EHRs)?

The two principal characteristics that differentiate distributed ledgers from the databases with which we are familiar are that they are more robust and, potentially, more private. Some even claim to be quantum computing hack proof although we will have to wait for hackers with quantum computers to test that.

Traditional databases are formed from one large or several linked entities that have a centralised control from where performance, data integrity and security are monitored and managed. There are human and technological factors that introduce weaknesses to all such systems, as the number of data breaches reported here over the years testify.

(more…)

HeyDoctor! Come and get your diagnosis via text here!

November 27, 2017 | by

An app that makes this semi-grizzled pioneer feel…not quite on board the wagon. HeyDoctor is not for horses, but for those who Text to Live. Yes, all you need to do if you feel under the weather is to download the app, text the doc, get your diagnosis, and prescription. Like that. No need to comb your hair and wash your face for that video visit. According to the website, you can get anything from a UTI to acne to erectile dysfunction diagnosed and treated. Out of birth control? Handled. You can get tests ordered up for blood typing, HIV, and metabolic analysis. Not happy with your lash thickness and growth? Here’s the topical med for you! Trying to quit smoking? Done. All you need do is text one of their in-house board-certified physicians and live in one of 19 states where it’s offered.

For our UK Readers, this is a service with similarities to Babylon Health‘s chatbot service but without the decision support ladder–it goes straight to the doctor.

They claim on the website that most visits are five minutes and under $20 in cost, plus affiliations with leading medical centers like UCSF and Georgetown, although this Editor doubts that Amazon Web Services (AWS) is a ‘healthcare organization’ in the same category.

MedCityNews confirms their playbook, for now, is B2C, but the San Francisco-based founders are considering partnering with health systems. According to Crunchbase, funding so far is seed from the two founders, Brendan Levy, MD, a SF-based family medicine practitioner, and Rohit Malhotra, an attorney. LinkedIn counts three employees.

So why not on board the Conestoga? While the convenience is very attractive, there’s also the opportunity for misdiagnosis–the kind of thing we used to worry about with telemedicine. Does the app secure the texts for privacy? Many of these conditions aren’t hangnails–HIV and UTIs come to mind. Oddly, photo upload isn’t mentioned–important with acne. Testimonials point to convenient prescription renewals, but that information can be falsified–easy to do with text. Identity too with smartphones can be faked. A video consult also permits the doctor to see the patient and pick up at least some physical signs of illness. Also not inspiring confidence: a website that crashed when I looked for FAQs and had a chatbot named Brendan (same face as Dr. Levy’s) constantly popping up after X’ing him out. To this Editor, it feels like some verification and diagnostic layers are…missing.

Anthem to Cigna: That’s Sabotage! You’re staying, like it or not! (updated 21 Feb)

February 16, 2017 | by

Breaking News in The War of the Payers. Late on Wednesday (15 Feb), Anthem received a temporary restraining order to block Cigna from terminating the merger. Judge Travis Laster’s decision in the Delaware Court of Chancery maintains the “legal status quo’ until an April 10 hearing, where he will hear arguments from both sides. Anthem is now able to proceed with a fast-tracked appeal in the DC Federal Court of Appeals to overturn the February 8 DC District Federal Court decision that denied the merger. The sole extension in the merger agreement is to April 30, which will be preceded by the Chancery Court hearing 20 days prior. Bloomberg, WSJ (via 4-traders.com)

Wednesday morning, Anthem had filed a temporary restraining order in Chancery Court to keep Cigna from ankling the merger, which would make an appeal moot. It was positioned in their February 15 release as “a temporary restraining order to enjoin Cigna from terminating, and taking any action contrary to the terms of, the Merger Agreement, specific performance compelling Cigna to comply with the Merger Agreement and damages.” Cigna wanted out immediately, as we noted on Feb 14, seeing no hope in challenging the District of Columbia Federal District Court ruling as Anthem does, and took the position that the extension was invalid. They also sought an additional $13 billion in damages for shareholders beyond the $1.85 billion breakup fee.

The language Anthem used in Wednesday’s release to justify the filing was harsh: “…Cigna does not have a right to terminate the Merger Agreement at all because it has failed to perform fully its obligations in a manner that has proximately caused or resulted in the failure of the merger to have been consummated.” Anthem then accused Cigna of actively working to sabotage the merger: “Cigna’s lawsuit and purported termination is the next step in Cigna’s campaign to sabotage the merger and to try to deflect attention from its repeated willful breaches of the Merger Agreement in support of such effort.”Also Forbes

Bottom line: ‘Cigna, you’re a bad and faithless partner, but we are going to force a merger by any means possible anyway.’ Cigna blames Anthem for botching the merger approvals. Does prolonging any of this make sense?

Updated 21 Feb The differences started at the very beginning, with C-level disputes on who would lead a merged company and other areas of governance, so obvious (and public) they were cited by DC Federal District Judge Amy Berman Jackson’s Feb. 8 decision. David Balto, an antitrust lawyer in Washington, dubbed it ‘a shotgun marriage that went sour’ and not to discount Cigna’s case for damages due to business harm. After reading this article, you’ll wonder why they even started. Hartford Courant

Analysis Any merger between Anthem and Cigna has become, despite the language, a hostile takeover, worthy of Frank Lorenzo in this Editor’s airline days, or more recently, Carl Icahn. Having worked for Mr Lorenzo years ago, observing from my tiny chair way over on the sidelines, I learned that hostile takeovers and poorly thought-out mergers don’t work out well, in service delivery or economics, short or long term. They usually end badly, in bankruptcy court, with many tears shed and lives wrecked.

Memo to Anthem and Cigna–is this really necessary? Here we are dealing with insurance, and service to policyholders/members, affecting both their health and wealth. You both talk a good game about saving on medical costs, accelerating the progress of value-based care, delivering value to shareholders, and improving quality. But you hate each other and have from the start. Playing the game of Who Blinks First, and the distraction of a long and bitter legal battle, cannot be anything other than harmful to your members, employees, doctor and health system providers, your bottom lines, and your future.

This is not the airline business, beverages or detergent. It’s people’s lives here–have you both forgotten? Enough! Stop now! Get back to the business of healthcare!

Previously and related in TTA: Cigna to Anthem: we’re calling it off too, Aetna’s Bertolini to Humana: let’s call the whole thing off, Anthem-Cigna merger nixed

The Theranos Story, ch. 29: Blame the scientists! Bring on the lawyers!

December 23, 2016 | by
[grow_thumb image=”https://telecareaware.com/wp-content/uploads/2016/11/jacobs-well-texas-woe1.jpg” thumb_width=”150″ /]It was the fault of the scientists and the investors! That is the speculation of Quora poster Drew Smith, a former R&D director at biotech firms MicroPhage and SomaLogic. It was a round robin of founder/CEO Elizabeth Holmes’ all-too-rosy forecasts and scientists not wanting to toss a wet wool blanket on the fun by telling her what she didn’t want to hear. Mr Smith, from where his experience lies, believes that the scientists discarded the testing with bad results, passing on only the good even if flawed, in a delusional circle that ultimately went pear-shaped. Then there were the investors, who didn’t apply the usual Deep Discount to the Big Hype that all entrepreneurs weave around the Revolutionary Whatevers, for whatever reason. On this, Mr Smith doesn’t speculate. It must have been those wide-screen blue eyes, black turtlenecks, and nanotainers that kept them mesmerized. Theranos wouldn’t be the first company that failed because they believed their own press releases and pictures! Forbes  Hat tip to reader Bill Oravecz of Stone Health Innovations and WTO Associates.

And the law firms multiply. Continuing to fight Theranos’ many lawsuits in multiple courts are a bevy of Big Law firms. In Chapter 26, Boies Schiller exited, stage left, and Wilmer Hale (formally Wilmer Cutler Pickering Hale and Dorr) entered. Wilmer Hale is representing Theranos in the California class action lawsuit described in Chapter 27 and what we’ve deduced is the Partner Fund Management lawsuit filed in Delaware (Chapter 21). Here’s where Santa unloads his jolly pack of toys for the Law Boys. Cooley LLP (32nd on The American Lawyer’s 2016 Am Law 200 ranking) is busy representing Ms Holmes, who has been separately sued by Partner Fund Management, and defending an Arizona lawsuit (Chapter 22). And on deck for Theranos in the Walgreens action, also in Delaware? (Chapter 23) Newcomer Wilkinson Walsh + Eskovitz, founded earlier this year by top trial lawyers from larger firms. All those billable hours add up to gold in their stockings, coal in Theranos’. Law.com

See here for the 28 previous TTA chapters in this Continuing, Consistently Amazing Saga.

Categories: Latest News, Opinion, and Soapbox.

WLSA merger with PCHAlliance: the digital health conference scene contracts a bit more

December 12, 2016 | by

Over the weekend, the Personal Connected Health Alliance (PCHAlliance) and the Wireless-Life Sciences Alliance (WLSA) announced that the San Diego-based WLSA would be combining its operations with the PCHAlliance. This follows on the earlier announcement [TTA 21 Oct] that the Boston-based and Partners HealthCare- owned Connected Health Symposium would be folding its operation into the PCHAlliance. Both Robert B. McCray, co-founder and CEO of WLSA, and Dr Joseph Kvedar of Partners HealthCare are now Senior Advisers to the PCHAlliance, with Mr McCraw heading Thought Leadership and Dr Kvedar now Program Chair of next year’s event.

WLSA has been largely inactive on the conference scene since 2015, when it staged its last Convergence Summit in May and the Wireless Health event in October of that year. The Convergence Summit has been merged into PCHAlliance’s Connected Health Conference kicking off today near Washington, DC. The Wireless Health event will continue through a collaboration with IEEE/EMBS cooperating with the National Institutes of Health (NIH) and the National Science Foundation (NSF).

In their release, PCHAlliance emphasized WLSA’s experience in research within engineering, computer science, biomedical and health disciplines. Patricia (Patty) Mechael, PhD, Executive Vice President, PCHAlliance in the release was quoted that “Their focus on medical and health research communities is a perfect compliment to our commitment to accelerate the adoption of clinical grade technology in consumer-friendly health outcomes- based business models.” Life science companies will be welcomed for membership in the PCHAlliance. PCHAlliance also includes Continua, which for well over a decade has been promoting engineering standards for device interoperability.

As this Editor looked back in October, when most of these organizations and events started about 2007-8, there were few Big Health conferences that took what was then dubbed eHealth and mHealth (later Digital Health) seriously. Now, of course, they do. There are also multiple events, large and small, expensive and popularly priced, every month in many cities–we attended and reported on #MedMo16 which will be branching out to multiple cities in 2017.

In looking back at our articles, the WLSA was engaged with the conference almost from the start, when the mHealth Summitwas one of the first ‘big name/big support’ conferences. Its tack then was governmental policy and what international NGOs were doing as a model for developed nations. It was organized by the Foundation for the National Institutes of Health, the National Institutes of Health and the mHealth Alliance up to 2012, when HIMSS took it over.

Grizzled Pioneers, and even the non-grizzled, can testify to the multiple phases in a decade up and down the Hype Curve: device-driven, mobile-driven, sensor-driven, telehealth, wearables, Big Data, population health, patient engagement, analytics, data integration, outcomes-based and a few others. This move confirms that many factors are blending: academic, engineering, software, biotech, genomics, social, behavioral, governmental–and that technology is not standalone or sitting in isolation, but is integrating and manifesting itself in all sorts of interesting places both behind the consumer scene and in policy, and to consumers on mobiles and in the home (IoT, which hasn’t resolved its multiple and obvious security problems).

Also Neil Versel in MedCityNews. TTA is a media partner of the PCHA CHC for the 8th year, starting in 2009 when it was the brand new mHealth Summit. Conference tweets on #connect2health.

Optum’s Utopia of proactive patient care–without telehealth

December 6, 2016 | by

[grow_thumb image=”https://telecareaware.com/wp-content/uploads/2015/10/question_mark.jpg” thumb_width=”150″ /]And we wonder why telehealth patient monitoring is floundering and telemedicine is only starting to take off? In this Editor’s reading today, up came this rather glossy, beautifully designed advertorial web page in The Atlantic sponsored by healthcare services provider/holding company Optum. It describes a proactive, highly supportive care process that starts with the diagnosis of a chronic condition (in this case developing CHF) through a ‘health scare’ handled at an urgent care versus a hospital ED, then to care at home (from a highly engaged nurse-practitioner no less) and a patient who, suitably engaged, is “responsibly managing her condition through a wellness approach” and has an improved lifestyle.

Other than an EMR (integrated between provider and urgent care–but EHR is the more current term), no other technology other than telephonic is mentioned in this rosy picture. Where’s the telehealth app that touches our patient, letting her chart her weight, breathing and general wellness, sending it to her EHR and alerting that nurse so she can truly be proactive in seeing changes in her patient’s health? Where’s the telemedicine virtual visit capability, especially if our patient’s out of breath outside of normal office hours, or there’s a blizzard and that nurse can’t visit? Here’s all the infrastructure built up for integrated care, but where’s the technology assistance and savings on home health visits and transportation for the patient?

It can’t be that Optum doesn’t know about what telehealth/telemedicine can do and the role it already plays in care? It can’t be that it doesn’t fit in the integrated care infrastructure? Or does it have to do with reimbursement? (Optum is the parent of giant insurer United Healthcare) Readers’ thoughts?

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

December 3, 2016 | by
[grow_thumb image=”https://telecareaware.com/wp-content/uploads/2016/12/jim_mattis.jpg” thumb_width=”150″ /]Does ‘Mad Dog’ ‘Warrior Monk’ James Mattis, General, USMC (ret.) have a blind spot when it comes to Theranos? President-Elect Donald J. Trump has selected him as the next Administration’s nominee for Secretary of Defense. A remarkable leader and, yes, scholar (check his background in various sources), but he has some ‘splaining to do, in this Editor’s opinion.

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

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

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

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

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

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

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

September 9, 2016 | by
[grow_thumb image=”https://telecareaware.com/wp-content/uploads/2016/04/Yak_52__G-CBSS_FLAT_SPIN.jpg” thumb_width=”150″ /]The deconstruction of Theranos continues, con il dramma, rounding back to those who touted it. There isn’t all that much new in Nick Bilton’s Vanity Fair article, but it adds context and color to this (literally) Bloody House of Smoke and Mirrors. (Ah, where’s Christopher Lee when you need him?–Ed.) There’s the usual Inside Baseball of closed-door meetings in ‘war rooms’, G150 jetting to awards, bodyguards, threatening lawyers, crisis managers, COO ‘enforcers’ (Sunny Balwani) and playing the Silicon Valley investor game (with Google Ventures taking a very smart pass). Where this gets unusual is the portrait of Elizabeth Holmes as an obsessive, secretive, blondined Steve Jobs knockoff from the age of 19, with a hot idea that never matched scientific reality from the start, but with a great line of ‘making the world a better place’ magnified by Silicon Valley’s incessant, We’re The Top And You’re Not narcissism.

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

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

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

Robot greeter on the job at Ostend, Belgium hospital–and those killer robots

June 21, 2016 | by
[grow_thumb image=”https://telecareaware.com/wp-content/uploads/2016/06/Robot-Belgique-1.png” thumb_width=”250″ /]This humanoid (but not Terminator-like, its developers are careful to say!) robot is currently on the job as a receptionist at Ostend, Belgium hospital AZ Damiaan. Equipped with healthcare-oriented software developed by local company Zora Robotics, the Aldebaran/SoftBank Robotics’ demure Pepper robot stands 1.2 meters (just under 4 feet), speaks 19 languages and works for about 20 hours on a single charge. Pepper communicates via its tablet interface but also is responsive to actions and emotions in what SoftBank calls a natural and intuitive way. The Pepper robot was first deployed in the hospital’s maternity area. The video has an awwwww…. illustration of a newborn grasping Pepper’s fingers. Previously, the toddler sized Nao robot worked with patients at AZ Damiaan for physical therapy. (Nao robots have also been featured in modern dance and as greeters at Japanese hotels and banks.) Reuters (video 1:51)

[grow_thumb image=”https://telecareaware.com/wp-content/uploads/2016/06/robottoy-1.jpg” thumb_width=”150″ /]This is a far more benign take on robots than the Daily Mail‘s recent screamer that “Killer robots are ‘quickly moving toward reality’ and humanity only has a YEAR to ban them” which conflates drone weaponry (human guided) with ground robots (human guided). As of now, They’re Still Puppets (more…)

Unintended consequences: American Well loses, loses patent, to Teladoc

June 18, 2016 | by

On Tuesday, the Federal District Court of Massachusetts not only dismissed the American Well patent infringement lawsuit against Teladoc, but also invalidated American Well‘s patent, held by co-founder Dr. Roy Schoenberg since 2009. It was invalidated on the grounds that the claims in the patent were “too abstract” to be patentable and do not “amount to an inventive concept.” American Well is appealing the court decision.

Teladoc started this call-and-response in March 2015 by petitioning the USPTO (US Patent and Trademark Office) to invalidate several American Well patents. (AW claims to hold 28 patents and 22 pending applications). Shortly before Teladoc’s IPO on the New York Stock Exchange last June, American Well sued Teladoc on patent infringement. Those in the industry saw an effort to scupper the IPO. Our Editor Chrys at the time took a decidedly jaundiced view of American Well’s grounds for infringement:
This author is wondering who thought this was such a novel technology as to warrant a patent? What were they thinking? Having worked on developing unified messaging systems for a mobile phone operator at the turn of the century (now that’s a scary 15 years ago) I am just picking myself off the floor after reading this.
Surely all these functions are no more than what is in every instant messaging program, dating back to 1990s? Replace the words “medical service provider” by “friends” or “contacts” and “consultation” by “chat” or “call” it seems to me you get … Skype and Face Time and more! [TTA 9 June 15]
No matter, the result was yesterday’s double shot of a decision. In addition, three Teladoc complaints against American Well‘s patents to invalidate them are still in progress with the USPTO. A triple, anyone? MedCityNews, Teladoc press release, American Well press release
All this is despite the sobering facts that telemedicine has been unprofitable to date–and that IP wars have unintended consequences. (more…)

Congressional investigation confirms NFL attempted to influence concussion, CTE research

May 25, 2016 | by

Not shocking to our Readers. In December, sports network ESPN reported that the National Football League (NFL) refused to fund research on detecting in vivo chronic traumatic encephalopathy (CTE) from a long-term $30 million unrestricted grant to the National Institutes of Health (NIH) [TTA 23 Dec 15]. A 91-page report by Democratic members of the House Committee on Energy and Commerce, which started after the December reports, confirmed that the NFL improperly attempted to shape the research after the grant, violating NIH peer-review process policies that stipulated no grantor interference. The NFL specifically objected to the objectivity of Boston University’s Robert Stern, MD heading up the $16 million project before the award in 2015, then tried to redirect the money, so to speak, in-house–to a group including Dr. Richard Ellenbogen, a member of the league’s panel on brain injuries and their bid for the project. Ultimately, the NFL withdrew the funding from the NIH, which went ahead with it. The project was awarded to BU, the Cleveland Clinic, Banner Alzheimer’s Institute (Arizona) and Brigham and Women’s Hospital in Boston.

The Congressional report’s six major conclusions were highly critical of the NFL in several ways and also scored the Foundation for the NIH for not acting as a ‘buffer’:

  1. The NFL improperly attempted to influence the grant selection process at NIH.
  2. The NFL’s Head, Neck and Spine Committee members played an inappropriate role in attempting to influence the outcome of the grant selection process.
  3. The NFL’s rationalization that the Boston University study did not match their request for a longitudinal study is unfounded.
  4. FNIH (Foundation for the NIH) did not adequately fulfill its role of serving as an intermediary betweenNIH and the NFL.
  5. NIH leadership maintained the integrity of the science and the grant review process.
  6. The NFL did not carry out its commitment to respect the science and prioritize health and safety.

When the grants were announced in September 2012 [TTA 7 Sept 12], there was great cheer that finally the NFL had decided that denial was, to use the old joke, a river in Egypt, and to do something about it. This also followed Army research on TBI being supported by the NFL. The first indicator that the funds were going elsewhere, as we noted a year later, was that a year later the Sports and Health Research Program (SHRP) funds were going to other medical problems like joint diseases and sickle cell anemia. While worthy, it had not been the prime publicized objective of the funds. The Congressional committee report also details how the NFL tried to steer the research away from Dr Stern, one of the leading researchers in the field, citing his support of players who refused to accept the CTE settlement in 2014. Beyond the NFL, research on CTE and concussion will impact any contact sports as well as the military and other head traumas. This Editor has previously reported on Dr Stern’s CTE research presentations in NYC and from other researchers in the field; search on NFL and Dr Stern both in current index and the back file. Congressional report, ESPN.com, New York Times.

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

May 19, 2016 | by

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

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

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

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

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

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

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

Is the clock at the funding pub pointing to ‘last call’? (Updated)

May 11, 2016 | by

[grow_thumb image=”https://telecareaware.com/wp-content/uploads/2012/12/crystal-ball.jpg” thumb_width=”150″ /]And we were having such a good time! UPDATED Having ridden a few hype curves (in health tech and out–remember airline deregulation?) and with the bruises to prove it, this Editor believes that she can spot a Cracking Market at forty paces. The hands on the clock appear to be near closing time, even as we party on. After all, DTC telehealth is forecast to be $25 bn in the US by 2025 (GrandView Research), if we make it that far!

Where are the sharp noises coming from?

  • The continuing fail of unicorns like Theranos [TTA 4 May and prior], now resorting to bullying the Wall Street Journal and negotiating with the alphabet (SEC, DOJ, FDA, CMS…), and the troubles of Zenefits. 
  • Another notable unicorn, the doctor booking site ZocDoc, being called out at last on their customer churn, low margins, and high customer acquisition costs. (As well as an irritant to doctors and office managers) New York Business Journal
  • Extremely high and perhaps insane rounds of funding to young companies with a lot of competition or a questionable niche. Higi is an odd little kiosk + consumer engagement program located in primarily Rite Aid drugstores–odd enough to score $40 million in its first venture round. (Ed. note: I shop at Rite Aid–and have never seen one.)This is after the failure of HealthSpot Station, which burned through approximately $43 million through its entire short but showy life. The low-cost, largely exchange plan insurer Oscar Health raised $400 million this February  ($727 million total) while UnitedHealth and others are dropping money-losing plans in most states. Over 50 percent of exchange co-ops went out of business in 2015, leaving doctors, health systems and patients holding their baggage. Again, low margins, high cost and high customer acquisition costs.
  • We’ve previously noted that funders are seeking ‘validation in similarity’–that a few targeted niches are piling up funding, such as doctor appointment setting, sleep trackers and wellness engagement [TTA 30 Dec 15]
  • Tunstall’s continuing difficulty in a sale or additional financing, which influence the UK and EU markets.
  • NEW More patent fights with the aim of draining or knocking out competition. We’re presently seeing it with American Well litigating Teladoc over patent infringement starting last year, which is only now (March) reaching court. It didn’t stop Teladoc’s IPO, but it publicly revealed the cost: $5 million in previously unplanned lobbying and legal costs, which include their fight with the Texas Medical Board on practicing telemedicine–which is beneficial for the entire industry. (But I would not want to be the one in the legal department explaining this budget line.) Politico, scroll down. But these lawsuits have unintended consequences–just ask the no-longer-extant Bosch Healthcare about the price of losing one. (more…)