Theranos–the drama and examination continues

April 27, 2016 | by

The latest chapters:

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

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

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

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

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

Blueprint Health graduates the Winter 2016 class

April 27, 2016 | by

Tomorrow afternoon (April 27) is Graduation Day–Demo Day–for ten startup companies which address problems across the healthcare spectrum. They are:

● Blue Mesa Health – Helps employers reduce health costs through a digital diabetes prevention program
● HealthKick – Provides employers with curated perks for branded health and wellness services
● NexHealth – Provides a mobile-first appointment booking and reminder platform for doctor’s offices
● PatientPrep – Increases physician productivity and patient satisfaction by collecting data prior to a visit
● Rappora – Streamlines the coordination, management and time tracking of home care employees (more…)

BeVITAL: French telehealth, American multi-reading biosensor

April 27, 2016 | by
[grow_thumb image=”https://telecareaware.com/wp-content/uploads/2016/04/HealthPatch.jpg” thumb_width=”150″ /]Paris-based telehealth company BePATIENT has partnered with Silicon Valley biosensor company Vital Connect for a remote patient monitoring system dubbed BeVITAL. The unusual part is that the Vital Connect sensor, HealthPatchMD, is about the size of a standard bandage–it adheres to the skin by the heart–and transmits multiple vital signs including single-lead ECG, heart rate, RR interval, heart rate variability, respiratory rate, skin temperature, body posture, fall detection and activity including steps. The BePATIENT PC/mobile telehealth platform has a patient facing mobile app (‘Fast Path’) app, currently available in the Apple App Store, with a clinician-facing reporting module. BeVITAL has been piloted already in Europe for post-discharge monitoring of over 80 surgical patients in clinical studies at five hospitals, with two more deployments this summer. In the Americas, the two post-discharge pilots will concentrate on heart failure, in the US at John Muir Medical Center in Walnut Creek and Concord, California and at the Hospital Infantile De Las Californias, Tijuana, Mexico. The latter study will be run by Scripps Translational Science Institute in San Diego.

BePATIENT’s platforms and ‘digital health modules’ are largely used in France, Europe and Australia, and also integrate devices from iHealth, Withings and fitness tracker Fitbit. The Vital Connect Platform is FDA-cleared, CE-marked and Ninsho Certified (Japan). In addition to the HealthPatchMD biosensor, which is reusable up to 500 times, they developed the single-use VitalPatch biosensor marketed in the US and Europe, and being tested by Philips for at-risk hospital patients (ZDNet). Release, KTVU News

Theranos’ triple whammy: CMS, DOJ and SEC

April 20, 2016 | by | 1 Comment

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

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

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

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

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

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

Two RSM events of interest on medicine’s future and Big Data/IoT (UK)

April 20, 2016 | by

Make a place in your calendar for two Royal Society of Medicine full day events coming up in May and June. Both organized by the Telemedicine and eHealth Section. Hat tip to Charlotte Cordrey, Event Team Manager, RSM

The future of medicine – the role of doctors in 2025
Thursday 19 May 2016  (Chaired by our own Editor Charles Lowe)

Big data 2016 (Clouds and the Internet of Things)
Thursday 2 June 2016

 

Charterhouse rejects buyout bid for Tunstall Healthcare, considers refinancing

April 15, 2016 | by

[grow_thumb image=”https://telecareaware.com/wp-content/uploads/2014/07/Big-T-thumb-480×294-55535.gif” thumb_width=”150″ /]Breaking News. Some long-awaited updates on the ongoing rumors regarding Tunstall Healthcare and a potential sale surfaced on Bloomberg late yesterday. Citing ‘people familiar with the matter’, Charterhouse Capital Partners, the owner and main investor, rejected a £300 million (US$425 million) buyout offer from private equity investment firm Triton Partners and reportedly will seek refinancing as an option if a buyout offer cannot be accomplished. However, the same sources state that talks are ongoing including with Triton and other potential investors and that no decisions have been made.

Triton is an investment firm registered in St Helier, Jersey and with locations through Europe, China and New York. It represents around 100 institutional investors and concentrates in investments in medium-sized businesses in northern Europe, Italy and Spain. In looking at their sector mix on their website, health is a small slice of their interests under consumer. This Editor speculates that they were seeking to expand this area, and perhaps sensed a bargain, because Tunstall by no stretch could be considered ‘medium-sized’.

Another interesting tidbit is that the cited sources indicated that before a refinancing, the company might need to be deleveraged. There is about £230 million in debt excluding shareholder loans and bank debt, which if included would bring the total to an eye-blinking net debt of £1.2 billion. Charterhouse purchased Tunstall in 2008 for £530 million. Current sales are £212 million for the fiscal year ending in September 2015, down from £215.2 million in 2014 according to a filing with Companies House (see 4 Dec 15 PDF in the filing history tab).

Tunstall’s statement: “Tunstall’s turnaround plan is well advanced and we are seeing improved performance,” the company said in an e-mailed statement. “Our focus is on delivering for our customers and helping them exploit the possibilities that new digital technologies present.”

This Editor’s reflection is that Tunstall is in the situation that nearly every company in telehealth and in health tech is in–a confusing market with segments as fine as a garlic clove sliced with a razor, too many players, too many segments with too many names, all chasing not enough money whether private or government.

Certainly more to come. Hat tip re the article to a Reader with long-standing experience in the telehealth field.

 

Eric Dishman departs Intel for NIH’s Precision Medicine Initiative Program

April 13, 2016 | by

[grow_thumb image=”https://telecareaware.com/wp-content/uploads/2016/04/20160411-eric-dishman-pmi-1.jpg” thumb_width=”150″ /]Late breaking news….Reported in Aging in Place Technology Watch from the Oregonian is that Eric Dishman, one of Oregon’s more famous sons (and certainly a star in health tech), is leaving Intel after 17 years. Currently an Intel Fellow and general manager of the Health and Life Sciences for the Data Center Group (profile), he is joining the National Institutes for Health (NIH) in their Precision Medicine Initiative (PMI) Cohort program as a director. According to the Oregonian, Mr Dishman “will lead an effort to study more than 1 million volunteers to study the impact of “precision medicine” – the practice of studying an individual’s specific genetic makeup and lifestyle to produce targeted treatments. It had been a key focus of Dishman’s work at Intel, and he had helped design the study he will now oversee.” Mr Dishman had his own extreme experience with precision medicine to treat his recurrent cancer in 2012, which made him eligible for a life-saving kidney transplant later that year [TTA 27 Feb 14 and 12 Apr 2013]. He had recently been a key part of the PMI Network working group in this ‘audacious’ study as NIH, in announcing his appointment, termed it. His last day at Intel will be 29 April, according to Intel’s data center chief. Replacing him (at least in the organization) on an interim basis will be Steve Agritelley. NIH release, USNews interview

Laurie Orlov (hat tip re this article–Ed.) commented to this Editor that Mr Dishman could be considered the ‘father of Care Innovations‘; certainly he was crucial to the development of the original Intel Health Guide out of Intel’s Digital Health Group, and was prominently in the leadership of the early Louis Burns days of the company. His work during Intel spanned over LeadingAge’s CAST, Ireland’s Technology Research for Independent Living (TRIL) Centre, Everyday Technologies for Alzheimer’s Care (ETAC) and the Oregon Center for Aging & Technology (ORCATECH). Mr Dishman’s work is marked by a singular focus on delivering health into the home, changing aging and hospitals as we know them. Now he will be more focused on genomic medicine and changing disease treatments as we know them.

Your Editors wish him good fortune and hope that his experiences with NIH and in Washington will be fruitful and all that he intends it to be.

Unspinning the Theranos scientific advisory board communications spin

April 9, 2016 | by | 1 Comment

[grow_thumb image=”https://telecareaware.com/wp-content/uploads/2016/04/Yak_52__G-CBSS_FLAT_SPIN.jpg” thumb_width=”150″ /]Spinning oh so flatly…..As reported in MedCityNews (and here) yesterday, Theranos has made a Radio City Rockettes-showy move in opening at least part of its scientific books to a prestigious group of eight academic researchers from top-flight institutions. The Theranos press release is a masterpiece of positive spin to counter the negative results of the CMS report released last Thursday. However, when the fine-spun web is picked apart by Matthew Herper, a staff reporter for Forbes, it embarrassingly falls apart. The clues are all there, of course, in the elided language, the lack of specificity on numbers, the over-the-top quotes from the CEO and one of the advisory board members….

Upon interviewing three members of the scientific and medical advisory board, the glowing statement of Dr Helfet–who had been a co-chair of Theranos’ existing scientific board–was revealed as not quite accurate in the impression it gave.

  • The full advisory board has not met as a group yet. The impression was given in the release that they did.
  • They were split into three groups, each spending about a day at the Palo Alto HQ “viewing data shown to them by the company about its blood tests, examining Theranos’ Edison machines, and asking questions”. They did not visit any working labs, including the two under CMS fire.
  • Drs Ladenson and Spitalnik thought that what they saw looked “promising” and “intriguing” but would not answer questions on whether Theranos’ devices were ready to be used. Eight hours for Dr Spitalnik was, as he stated, was enough to whet the appetite, but not more than that.

It remains that Theranos has not published one peer-reviewed study, despite promises, promises. The company leadership took in a lot of investor money, gained a $9 billion valuation, got Safeway and Walgreens as partners (now rescinded)–never proving that Theranos’ tests would do what they said they would do. Besides being the bottom line and the one proposition that must be proved, they potentially endangered trusting patients in Arizona and California. And gave a black eye and probably a broken nose to innovation in and consumer access to lab testing.

At least the Yak-52 aerobatic aircraft and its pilot are in a planned, recoverable flat spin. Nothing about Theranos’ spin can be. Forbes

6th Global mHealth App Developer Economics Study–early results in

April 8, 2016 | by

[grow_thumb image=”https://telecareaware.com/wp-content/uploads/2016/04/r2gprelimresultsinfographv2.jpeg” thumb_width=”200″ /]research2guidance has shared with the Editors some of the preliminary results of the 6th Global mHealth App Developer Economics Study. Currently at 2,000 participants and open till the end of May (click here to take the 15 minute survey), it has grown to be the largest global market study of the sector. (Last year’s study topped out at more than 5,000 industry respondents and is available as a free download here.) For their time, respondents can view initial results upon completion of the survey, after publication in 2nd Quarter receive a copy of the report and be automatically entered into their prize draw of an Apple Watch or Samsung Gear.

Many of the results to date are neatly summarized in the infographic at left and below:

  • 61 percent believe mHealth solutions can cut costs through therapy adherence
  • 65 percent believe mHealth adoption could save costs by shortening or avoiding hospital visits
  • Market potential as a distributor: app stores still lead (61 percent) but half believe health insurers are now second. Doctors and hospitals trail at 42 percent and 38 percent respectively.
  • Most positive impact: following up and monitoring of conditions; information provision; diagnosis and treatment
  • But goals are still distant: 53 percent of respondents revealed they had only “partly achieved their goals”. 4 percent claimed their mHealth “dreams came true”. (Perhaps those who had their companies acquired? — Ed.)

r2g release.

TTA and DHACA (Editor Charles, Managing Director) are media partners for this study. Hat tip to Sean Phillips of r2g. Previously in TTA, Charles’ original article.

Expanding cross-state telemedicine licensure for nurses promoted (US)

April 8, 2016 | by

In the US, nurses, like doctors, are licensed by state and cannot practice in others, unless they are separately licensed in that state, or licensed in one of the 25 member states of a compact permitting cross-state practice. Currently, it does not include the practice of telemedicine or in fact, telehealth monitoring across state lines. The new Enhanced Nurse Licensure Compact and Advanced Practice Nurse Compact includes telemedicine remote consults and was initiated by the National Council of State Boards of Nursing, a Chicago-based non-profit consisting of 59 nursing boards, last year. The objective is to further advance mobility and flexible practice for nurses. The new compact has been accepted by six states: Wyoming, Virginia, South Dakota, Idaho, Florida and Tennessee. Other states are considering via legislation. The NCSBN is boosting it with an event in Washington DC on Friday. ATA has supported the compact, as well as a similar one for physicians now valid in 12 states.  mHealthIntelligence  NCSBN release (which uses telehealth as term) ; they are also hosting a webcast from Washington on Friday morning from 8:30am to 1pm US EDT.

Rock Health: 1st Q funding deals up nearly 50%, approaches $1bn (US)

April 7, 2016 | by

[grow_thumb image=”https://telecareaware.com/wp-content/uploads/2016/04/RockHealthChart1.001-1200×845.jpeg” thumb_width=”150″ /]Funding’s up, but the digital darlings have changed. The stock market and tech sector may have been uncertain kicking off 2016, but digital health wasn’t. Rock Health’s first report for 2016 exudes optimism. Compared to the same quarter in 2015, funding increased nearly 50 percent to $981.3 million, the highest amount since 2011. But the devil may be in the details:

  • Five deals accounted for 56 percent of the volume (in descending order: Flatiron Health (clinical intel for cancer care), Jawbone, HealthLine (consumer health info), Health Catalyst (data warehousing) and Higi, an odd little kiosk + consumer engagement program nationally placed in Rite Aid stores–odd enough to gain $40 million in its first venture round
  • Seed and Series A raises were still well over half–54 percent, over the 50 percent in 2015
  • Later stage deals (Series D and above) shrank to 13 percent in 2016 from 35 percent
  • Top categories also demonstrated the fickleness of funding favorites. Only two categories in the top six were carry-overs from 2015: wearables (driven by Jawbone) and consumer engagement. New favorites: analytics/big data, population health management, consumer health information and EHR/clinical workflow.
  • There were no venture-backed IPOs in the quarter, and public company performance was down (9 percent y/y)

The new picture favors what to do with the data–finding trends and putting them to use both consumer and clinical sides. And exits were popular as well: 187 was the Rock Health count, with fitness wear Asics‘ acquisition of the Runkeeper fitness wearable and provider One Medical acquiring the Rise app. Will the trend continue in 2nd quarter? Stay tuned….Rock Health Q1 Update

Google’s Verily rolls along. Bumpily? (updated)

April 6, 2016 | by

Several articles of late have reported on the Google Alphabet life sciences company Verily. By fall last year, they had developed partnerships with Novartis-Alcon on development of a smart contact lens (for measuring glucose), plus Dexcom, Abbvie and Biogen. STAT, a health/medicine news website owned by Boston Globe Media which is still in beta, has a well-researched article that details, seemingly with a lot of inside scoop, its current turmoil. 12 top engineering and science executives have taken a powder. Some of the execs date back to the Google X days; most have fled back to Mother Google, others to Amazon or to life sciences competitors. STAT: “No similar brain drain has occurred at Calico, another ambitious Google spinoff, which is focused on increasing the human lifespan.” The reasons are the apparently abrasive CEO Andrew Conrad, depicted as ambitious, fickle and moody–and the constant shifting of support from approved projects to short-term initiatives ‘that show little promise’. Google’s bold bid to transform medicine hits turbulence.

Update: STAT published today information on a possible conflict of interest in Verily awarding a short-term research contract to a luxury health clinic, California Health & Longevity Institute, where Dr Conrad holds a majority ownership. According to the publication, it has no documented experience with this kind of work. The clinic will gather, in a 200-person ‘feasibility study’ for the larger Baseline study, genetic, molecular, clinical, and other data. According to Dr Conrad, it was done “Because I think it’s cool. Because it’s super efficient to have everything in one spot.” What may not be cool to the participants is that Baseline is already planning to sell the data to pharmaceutical companies–with patient consent, of course, in a document not yet public. Google’s biotech venture hit by ethical concerns

‘Gear Blink’? Samsung patents an embedded camera in a contact lens (S. Korea)

April 6, 2016 | by
[grow_thumb image=”https://telecareaware.com/wp-content/uploads/2016/04/samsung-smart-contact-lens-1.png” thumb_width=”150″ /]A Samsung news tracking website, SamMobile, has tracked down publication of a Samsung patent filing for a smart contact lens. This concept would have a camera with a display that would project directly into the eye, a tiny antenna that transmits images to the smartphone, and motion sensors that trigger by movement and blinking. This is different than the Google/Alcon lens in their new Verily Life Sciences division (TTA 17 July 14 and 1 Sept 15, pictured in the Mashable article) which is for measuring blood glucose. Samsung apparently filed the patent in 2014, and filed the ‘Gear Blink’ name for a trade mark in the US and South Korea. No clue on how comfortable a lens with a camera, antenna and display would be on a normal eye. Hat tip to former TTA Ireland Editor Toni Bunting.

The King’s Fund needs a press communicator (UK)

April 5, 2016 | by

A nine-month contract is open at The King’s Fund for a Press and Public Affairs Manager. Initially a maternity cover, a person in this position will deliver media coverage, disseminate their work to stakeholders and oversee some communications projects. More information and a link to application here. Hat tip to Claire Taylor of the KF.

TTA is a media partner of The King’s Fund Digital Health and Care Congress coming up this July, offering a 10 percent discount on registration to our Readers at this link (or click on the advert in the right sidebar); however we continue to offer free job postings like this or situations wanted, so take advantage!

Abstracts for Med-e-Tel now online

April 5, 2016 | by

[grow_thumb image=”https://telecareaware.com/wp-content/uploads/2016/04/Med-e-tel-logo.jpg” thumb_width=”150″ /]Med-e-Tel Luxembourg, one of the longest continuously running health tech conferences in Europe (from 2004, certainly enough to qualify it as a Grizzled Pioneer), will be on this week from Wednesday to Friday, but if like this Editor you’ll be unfortunately far, far away, Prof. Maurice Mars, Richard E. Scott and Malina Jordanova of the organizing International Society for Telemedicine & eHealth (ISfTeH), have published the speaker abstracts online and free (requiring only registration.) See them here.

The abstract researchers span the globe–Nigeria, Greece, Sweden, Czech Republic, Brazil, New Jersey (!)…plus several from UK (including Malcolm Fisk), Portugal, France, Spain, Italy, South Africa and Bulgaria. Orange Labs will present the data of their diabetic bike riders from the 2015 mHealth Grand Tour (MHT)–this was a high point of last November’s mHealth Summit/HIMSS Connected Health [TTA 13 Nov 15]. There’s also research on topics you don’t hear about in most conferences: smart cities, mHealth’s environmental impact, telenursing, adapting eHealth to serve those of differing abilities, even substituting smart technologies for physical restraints. So many unusual views are represented here. Also in this issue, Vol 4 (2016), is a wealth of research from Brazil.

More in the Med-e-Tel update press release.

Theranos flunks CMS review. Is there a there, there?

April 3, 2016 | by

There is no kinder way to put it. The impression that Theranos is equivalent to what writer Gertrude Stein said of her vanished home in Oakland, California–‘there is no there there’–is building. The US Center for Medicare and Medicaid Services (CMS) after multiple inspections in 2014 and 2015, found that the company failed its own standards on its proprietary Edison blood-testing and analysis system. Cited by the Wall Street Journal, which had access to the full 121-page report, is that “erratic quality-control results for Edison-run tests were frequent in July 2014 and from February 2015 to June 2015.” Overall, Edison devices produced test results that differed widely from traditional lab machines for the same blood samples. Additional problems were unqualified staff, blood samples at the wrong temperature and delays in notifying patients of flawed tests.

Theranos has promised to make further corrections at its Newark, California testing site but it may be too late. “CMS has deemed the company’s plan inadequate and plans to impose sanctions against Theranos, according to people familiar with the matter. In January, the agency said the punishment could range from fines to suspending or revoking the lab’s certification to legally test human samples.” (WSJ)

No stronger case has been made for an early-stage company under-promising and over-delivering than this, especially in health. There is no joy in hearing the grand slam of its $9 billion valuation cratering, but on the other hand, there are a lot of other worthy startups and early-stage companies which could have used the funding. A high profile fail such as this scares off investors from angels to VCs worldwide and tarnishes the entire health tech sector as well as young entrepreneurs. Also many of us looked forward to inexpensive, retail driven, minimally sampled blood testing.

In this Editor’s view, the wide-eyed CEO Elizabeth Holmes should attend more to the integrity of her company’s operations and less to working political connections such as Hillary Clinton fundraisers (last month) and putting everyone from Henry Kissinger, George Shultz and retired Marine Gen. James Mattis on the company’s board of governors (BioSpace). In Marine-speak, knock it off.

Ed. note: If the WSJ is paywalled (search on the headline “Theranos Devices Often Failed Accuracy Requirements” to get around it), see BioSpace. Previous coverage in TTA here.

Update 7 Apr: Some effort in the operations integrity area was made with another Theranos announcement of eight Scientific and Advisory Board members appointed (only two with any previous connection to the company) and three scientific review sessions at their Palo Alto HQ. MedCityNews