The Theranos Story, ch. 25: is the nadir the $400,000 harassment of whistleblower Tyler Shultz?

November 18, 2016 | by
[grow_thumb image=”https://telecareaware.com/wp-content/uploads/2016/11/jacobs-well-texas-woe1.jpg” thumb_width=”150″ /]A story to make your blood…boil. Tyler Shultz is a 26 year old Stanford University grad with a biology undergraduate degree. He ‘fell in love’ with the Theranos vision of quick small blood sample testing after visiting his grandfather’s home near the campus and meeting, of all people, Elizabeth Holmes in 2011. Tyler snagged a summer internship and then a full time job during their salad and steak days (September 2013). He worked on the assay validation team, which verified the accuracy of blood tests run on Edison machines before they were deployed in the lab for use with patients.

Then it all went sideways…and down. Ms Holmes was at his grandfather’s because he is George Shultz, 95 year old former secretary of state and Fellow at the Hoover Institution based at Stanford. Mr Shultz was one of the numerous Washington alumni lending luster to the Theranos board (now advisers), such as Henry Kissinger, Sam Nunn, James Mattis and Bill Frist (the last the only one with an MD).

Tyler Shultz soon discovered, like many new graduates, that his dream job wasn’t all that it was cracked up to be. Except that it wasn’t the hours or the quality of the snacks. He discovered that the Edison machines had highly variable results when tests were rerun with the same blood sample–and they routinely discarded the outliers from the validation reports. Edison testing for a sexually-transmitted infectious disease had a claimed 95 percent sensitivity. “But when Mr. Shultz looked at the two sets of experiments from which the report was compiled, they showed sensitivities of 65% and 80%.” It only got worse when he moved to the production team, where quality control standards were routinely flunked and President Sunny Balwani pressed lab employees to run the tests anyway. Mr Shultz went directly to Ms Holmes, twice, received a nastygram from Mr Balwani for the second, and quit–but not before anonymously sending results to the New York officials who administered a proficiency-testing program and who confirmed that the results sounded like ‘PT cheating’.

The rest of the story by John Carreyou is one of corporate harassment and family estrangement: legal harassment (including private investigators) by none other than David Boies’ law firm on the pretext of ‘confidential information’; the manipulation, currying of favor and misleading of a great but aged man; and a family’s trust fractured if not broken, despite the grandson being proven right, ironically, by the same Washington agencies that his grandfather so loyally served. Mr Shultz is now working on the Cloud DX team for the VITALITI Diagnostic Android Application in the running for the Qualcomm Tricorder XPRIZE. Wall Street Journal  See here for the 24 previous TTA chapters in this Continuing Saga.

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

November 17, 2016 | by

[grow_thumb image=”https://telecareaware.com/wp-content/uploads/2016/11/jacobs-well-texas-woe1.jpg” thumb_width=”150″ /]When will we find the nadir of Theranos’ business practices? Between the excruciating details of the Walgreens lawsuit and the treatment of an employee who knew the truth in 2014 (part 2), the bottom, like Jacob’s Well in Texas at left, may be unfindable.

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

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

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

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

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

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

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

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

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

S-t-r-e-t-c-h that sensor patch! Stanford’s breakthrough for health wearables

November 17, 2016 | by
[grow_thumb image=”https://telecareaware.com/wp-content/uploads/2016/11/Stamford-stretchy-sensor.jpg” thumb_width=”150″ /](Photo: Nature) Here’s a stretchy polymer with the right stuff for wearables. It can stretch, wrinkle and heal like skin. It can be ‘healed’ if damaged. Most of all, according to the Chemical & Engineering News article summarizing the Nature letter (PDF link) authored by the Stanford University team, it “has an electronic performance on par with amorphous silicon, the material that’s used in transistor arrays that control liquid-crystal display pixels. And it maintains that electrical performance even when stretched to double its original size.” We have been following stretchy sensors for some years, highlighting the pioneering work of John Rogers, a materials scientist at the University of Illinois, Urbana-Champaign and his team, whose work has been commercially marketed through MC10 [our back file here], but the difference here is the process. Rogers and others have been meticulously building rigid sensors onto a rubbery material that has some ‘give’. In Rogers’ words, “Stretchy mechanics and efficient charge transport typically do not go together.”  Bao’s group has developed “clever chemistries that seem to capture both properties in a single material.” Early days still, but tremendous potential in healthcare wearables for those who truly understand the technical aspects of this and develop accordingly. Hat tip to Jerry Kolosky of Panasonic via LinkedIn

The ‘unindicted ejaculator’, cognitive dissonance and leadership

November 17, 2016 | by

Guest Contributor Rachel Stone, recruitment coach at UK recruitment agency RSE Group, offers this striking view on the power of cognitive dissonance. Her points on performance and leadership are highly applicable to those of us providing and developing healthcare tech and services, which are dependent on our view of our end users.

What can the DNA, a prosecution team and the ‘unindicted ejaculator’ teach us about leadership?

Do you know the kind of situation where you really believe something and you desperately want it to be true? For example, you believe that you are right about something and if it turns out that you were wrong it would be quite painful?

What if you believed that a person was guilty of something terrible in your company? What if you were sure they had done this dreadful thing? All your instincts told you it was their fault and your belief had caused you to act in a certain way and led you to taking drastic action. If you had to go back on this, it could cost your dearly in terms of finance and reputation. Heaven forbid you were wrong……

As a good leader, you would have checked your evidence… You would have been sure to check your facts… Surely you would have not have taken that action if there wasn’t the right evidence available…

Sometimes, despite our best endeavours, our brain plays tricks on us when our beliefs are challenged.  Our brain tries so hard to up-hold our beliefs and can go to extreme lengths to maintain the status quo.  Our brains don’t like our beliefs being challenged. Even when there is undeniable evidence.

The study of this human trait is covered by cognitive dissonance theory:

According to cognitive dissonance theory, (Leon Festinger) there is a tendency for individuals to seek consistency among their cognitions (i.e., beliefs, opinions). When there is an inconsistency between attitudes or behaviours (dissonance), something must change to eliminate the dissonance. (24 Nov 2010)

There is a great deal to learn about this – especially as leaders.  Important decisions are made all day, every day.  All behaviours are based on beliefs and leadership behaviour must be exemplary. You act on what you believe in.

I’ve been blown away by what the excellent book “Black Box Thinking” by Matthew Syed can teach leaders about cognitive dissonance. I would urge you to check yourself in relation to this.  (In fact, I would recommend Syed’s book as mandatory for all leaders or potential leaders of the future, such is the importance of the learning contained within, not just this chapter.)

Syed describes, with compelling stories based in research and evidence, just how difficult it is for people to acknowledge when they are wrong. (more…)

UK HealthTech Conference, Cardiff, 6 December (UK)

November 16, 2016 | by

6 December, Mercure House Hotel, Cardiff, Wales

Exploring critical strategic trends in both health tech and biotech is this full day conference in Cardiff that is expected to have 300 participants. This year’s conference theme is patient safety. Keynote speaker is John Wilkinson, Director of MHRA. Full information, speaker and programme information, registration and sponsorship starts here. Hat tip to Dr Malcolm Fisk (@malcolmjf) via Twitter.

‘Chief Health Officer’ moms want 24/7 connected health for the family: survey (US)

November 15, 2016 | by

A just-released survey by Blue Cross Blue Shield of Georgia and telemedicine provider LiveHealth Online indicates a near-total desire for–and ability to access–on-demand, 24/7 healthcare and virtual visits. The key motivations are economic, convenience and educational: 71 percent cited the loss of at least two hours of time at work and school due to taking their child to the doctor’s office.

Given their age (starting at 18 and up to 59), the 500+ moms surveyed not surprisingly felt confident using health technology, with 82 percent believing themselves to be the most ‘health-tech savvy’ in the family.

  • 64 percent stated that having access to healthcare on-demand was more important than having streaming video or food delivery
  • 64 percent (64%) of women surveyed said they found it challenging to take their kids to the doctor during office hours during the school year
  • 79 percent said they would be interested in trying or learning more about telemedicine to help themselves and/or their family when faced with a non-emergency medical issue

Over half–54 percent–believed that online video doctor visits would improve their confidence in attending to family health, “like having a health security blanket”.

The survey apparently did not test for price sensitivity; for instance, per visit fees and amount subsidized by the payer.

It was conducted earlier this year by EmpowHER, an online health community for women. BCBSGa’s interest is that it offers coverage for online visits to many of its health plan members via LiveHealth Online, which uses the American Well network but is a separate company. BCBSGa release, EmpowHER/LiveHealth infographic, Internet Health Management

An interesting adjunct to this survey would have been to ask about ideal healthcare tools used in conjunction with that online doctor visit. This is anticipated to be a major market for advanced ‘all-in-one’ telehealth diagnostic units such as those developed by Tyto Care, Scanadu Scout or MedWand [TTA 2 Nov]. These are not only capable of taking standard vital signs, but also clinical quality digital pictures of those sore throats and inflamed ear canals.

Health tech’s disruptive power in pictures

November 14, 2016 | by
[grow_thumb image=”https://telecareaware.com/wp-content/uploads/2016/11/health_tech_top-675x372_c.jpg” thumb_width=”300″ /]

One of our Readers works for an agency that developed, under the direction of home care provider CEO Ryan McEniff, a digital health infographic which is packed with facts on how technology is changing healthcare processes, hopefully for the better. It’s a little lengthy but it covers how many tasks will be automated, workforce changes, global investment highlighting the US, Singapore, Canada and Australia, leading accelerators, startups and companies, how markets are accepting technology and the international challenges. What you need for your next meeting! Courtesy of Minute Women Home Care  (@MWhomecare) of Lexington, Massachusetts, Ryan and reader Veronika Gorina. Full infographic follows.

(more…)

Samsung’s $8bn Harman buy: what’s the digital health implications? (UPDATED)

November 14, 2016 | by

UPDATED Monday’s big news (other than the Dow Jones post-US election climb, China getting shirty on trade and the severe 7.8 magnitude quakes near Christchurch NZ where we hope our Readers are OK) is the $8bn acquisition of Harman International by Samsung Electronics. Those of us who are most familiar with Connecticut-based Harman in the audio area (in cars and Harman/Kardon speakers on this Editor’s bookshelf) will be surprised at their powerhouse status in the automotive industry as a technology hardware and software supplier to GM, BMW and Volkswagen. Its technology is in 30 million vehicles and is tidily profitable. It is also unusual for Samsung as they have tended to grown internally and organically, versus by acquisition. Harman will be operated as a standalone company. (Articles also point out the change at Samsung’s top, with a new generation ascending to control this family-controlled company.)

It diversifies Samsung well past the uncertainties and the maturity of the smartphone business not only into a direct supplier relationship with car makers, but also in how the relationship between man and car transportation is changing. Beyond the obvious like self-driving (piloted driving) cars where Tesla, Ford, Uber, Apple and Alphabet are playing (and the more near-term area like partial assistance in driving), there is a chicken-egg dynamic on cabin enhancements–what can be done versus what should be done. (Designer Raymond Loewy’s MAYA–most advanced yet acceptable.)

  • What connected technologies are helpful and valuable to the driver and passengers?
  • Which ones increase safety, autonomy and security?
  • Which ones add to the driver ‘load’ of distractions and increase danger to the driver and others?
    • Pilots term this a too-busy cockpit. Remember that drivers aren’t pilots and don’t go through checklists and walkarounds before and after driving. We want to turn the key, tune the radio and go.
    • Which ones can be made to be not distracting?
  • What happens when the technologies malfunction or break?
  • What happens to cost and affordability? (All the whiz-bang tech can put a vehicle out of reach for the many. It would be counter-productive and elitist to return driving to the early 20th Century decades where cars were owned by the few and wealthy–Henry Ford and Alfred Sloan had a different thought), though some would like that outcome.)
  • How seamless and secure can IoT be in a vehicle, as it is not secure at present?

All these are in the sub-text of five mega-trends noted at last week’s CES Unveiled New York by the Consumer Technology Association, notably as part of the cheerleading around ‘Transportation Transformation’ and ‘Connections and Computations’. (More about this separately in a later article on CES Unveiled.)

Let’s drill down into the nearer-term health tech aspects, where Samsung has been a leader in their phones and tablets, and what the Harman acquisition might mean there.

The first is the mobilization of what is presently in the home and phone.  (more…)

IBM Watson being trialled for diagnosing rare and hard-to-diagnose diseases (DE)

November 10, 2016 | by

The Centre for Rare and Undiagnosed Diseases in Marburg, Germany is known internationally as a healthcare resource for medical centers and physicians who suspect their patients have an unconventional and statistically rare medical condition. Often patient histories are inch-thick and replete with unstructured data such as X-rays, lab results, doctors’ notes and scans, reviewed by multiple medical professionals before reaching Marburg. How to review this data more promptly and better? The first step is to input this anonymized data into IBM Watson. The Marburg Centre will first ask patients to answer a 1,200-question digital questionnaire. This information will also include factors that may impact the diagnosis, from symptoms and family history to the environment they live in and their jobs. The data is also translated from German to English so that it can be cross-referenced to English-language medical information. For the 12-month pilot, Watson will provide Marburg’s staff with a differential diagnosis — a list of potential illnesses that fit the patient’s symptoms — which they then review. Watson can provide a percentage of possibility, which Marburg may skip as these are, after all, rare diseases. The Watson decision tool is being tested retrospectively on already-diagnosed patients. ZDNet

Digital Epidemiology: on-demand public health

November 10, 2016 | by

Guest Editor Sarianne Gruber (@subtleimpact) reviews the meta-trend of digital epidemiology, which gathers ‘digital exhaust’ information through social networks, chat rooms and other online media, analyzes it at the population level and tracks localized outbreaks of diseases like the Zika virus and flu. It even has inspired new models of vaccine delivery and patient transportation such as Uber Health and Circulation.

The Internet has a rather detailed picture of the health of the population, coming from digital sources through all of our connected devices, including smartphones. This is digital epidemiology: the idea that the health of a population can be assessed through digital traces, in real time. Digital Epidemiology: Tracking Diseases in the Mobile Age. M. Salathé, J. Brownstein et al.

As a Harvard Medical School Professor and the Boston Children’s Hospital Chief Innovation Officer, the plights of patients and the hurdles in care are Dr. John Brownstein’s starting points for questions and discovery. When the Community Transportation Association study reported “an estimated 3.6 million patients the United States miss at least one appointment due to lack of access to transportation”, Brownstein was determined to make this challenge his own. This fall, he launched the first customizable patient-centric digital transportation system – Circulation – a new vision for non-emergency medical transportation. As a Klick Health Muse attendee and having had the privilege to speak with John Brownstein, Ph.D., co-founder of Circulation, I would like to share what I learned about his journey as an epidemiologist, public health educator, and innovator.

Social Media’s Big Data: Preventing Epidemics and Tracking Drug Safety
Digital epidemiologists think in terms of “digital phenotype” to understanding the health of individuals. Uncovering critical information about what is happening at the population level is collectively called “digital exhaust”. These digital traces that are left behind, help track local outbreaks around the world. “In fact, you don’t need surveys, just mine what people are saying online. We combine social media to get real insights as to what is happening on the ground: facts and sentiment. The ability to understand risk and population health is fantastic with these emerging technologies,” opened Dr. John Brownstein at the 2016 New York City KlickMuse event.

Social media mixed with disparate sources of health data was how Brownstein began solving public health risks. (more…)

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

November 9, 2016 | by

[grow_thumb image=”https://telecareaware.com/wp-content/uploads/2015/11/upside-down-duck.jpg” thumb_width=”150″ /]Walgreens Boots Alliance has finally sued Theranos in Delaware Federal Court in for breach of contract.  Walgreens is seeking $140 million, supposedly equivalent to their amount invested, according to sources cited in the Wall Street Journal article. Not many details are available, since Walgreens moved to seal the civil suit under their mutual non-disclosure agreement.

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

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

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

Health Wildcatters Pitch Day event

November 8, 2016 | by

Wed 16 November, 2:30 PM – 5:00 PM CST, Dallas Texas

Texas accelerator Health Wildcatters is presenting its Pitch Day 2016 featuring 10 early-stage companies: Amity Cloud, ClinicalSolutions, Endogenesis, Friendly, HealPal, HealthNextGen, KnKt’d, MediBookr, Optologix, and Oqulus. More information and tickets ($10–if you book same day they are $20) can be booked here. This includes a reception afterwards at Health Wildcatters’ offices nearby. Hat tip to HW CEO and co-founder Hubert Zajicek via Twitter

Chubb upgrades fall detector to identify, cancel a false alarm (UK)

November 8, 2016 | by
[grow_thumb image=”https://telecareaware.com/wp-content/uploads/2016/11/Chubb_07112016_Comm-Care-independent-living-image-wrist-fall-2.jpg” thumb_width=”150″ /]Chubb Community Care on Monday announced an upgraded fall detector which can both identify and if appropriate, cancel a fall alert alarm. “During the first 20 seconds of an incident, cutting-edge algorithms perform silent analysis of the situation, recognising if an individual is back on their feet,” according to David Hammond, general manager, in describing how the system differentiates a fall from a false alarm.

The self-cancellation software has been improved to help differentiate between types of movement, for example if the person is moving on the floor where help is needed, which may apply to epileptics having seizures, versus standing up and mobile. The wrist-worn device also has a standard button alert to summon help. If an alarm happens, it has a confirmation feature that indicates that help has been called by flashing a red light and vibrating for 20 seconds. The user at that point can manually cancel the activation or let it continue. According to Chubb, the product is presently in-market.  Release.

Tender Alert: Circle Anglia–Centra seeking e-commerce provider

November 8, 2016 | by

Our Reader Susanne Woodman has once again tipped our UK Readers to another opportunity related to telecare, this one with Circle Anglia and Centra which provide telecare and housing services in the UK. Centra is looking for an e-commerce system. The value of the tender excluding VAT is £120,000. According to the tender, Circle Housing would like to conduct soft market testing w/c 5 December at its Tower View Offices with the contract to be published in January 2017. More information is here on the TED-Tenders Electronic Daily website. Email Michelle Saunders for a further information document at michelle.saunders2@circle.org.uk

NZ’s public health advice line continues to grow

November 7, 2016 | by

New Zealand’s public health advice line is handling more inquiries than ever, with a 16% increase in the twelve months to September 2016. In a press release following the recent visit by the Health Minister Jonathan Coleman to one of the four call centres the Government said that more services will be added to the advice line in the coming months.

Seven advice lines, operated by multiple providers, were brought together a year ago and the 24/7 advice service now operates out of four call centres and employs 250 people, according to Dr Coleman. Known as the National telehealth service (bit of a misnomer), it is operated by Homecare Medical owned by ProCare and Pegasus Health, two of New Zealand’s largest health organisations. It brings together advisory services for queries relating to general health, alcohol and drugs, depression, gambling, immunisation, poisoning  and  quitting smoking. The advice can be obtained through phone, text and online programmes and some are delivered though partner organisations such as the National Poisons Centre.

This is similar to the UK’s non-emergency NHS 111 service that provides a 24/7 free advice line giving access to trained advisors supported by healthcare professionals, except that the UK service is probably more integrated.

Should Australia review restrictions on use of telemedicine?

November 5, 2016 | by

Research carried out in Australia shows that a hospital with telemedicine facilities for outpatient consultations was using those facilities for only one in seven potential appointments. The retrospective study of outpatient appointments at Princess Alexandra Hospital in Brisbane showed that in a 12-month period 2.5% of outpatient consultations were carried out by telemedicine. Although 17.5% of the appointments were potentially viable via telemedicine, a policy of permitting telemedicine only for rural residents meant that, as the majority of the viable telemedicine consultations were with metropolitan residents they were carried out as hospital visits.

This raises the question whether expansion of the use of telemedicine for hospital consultations in Australia should now be reviewed. Currently there is a geographic requirement that the patient’s location must be outside of an Australian Standard Geographic Classification Remoteness Area 1 (a city) for a telemedicine consultation  to be eligible for Medicare Benefits.

The research has been published in the Royal Society of Medicine publication Journal of Telemedicine and Telecare. The author, Monica Taylor, also presented the findings at Successes and Failures in Telemedicine 2016 in New Zealand where she was awarded the best paper award.