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leadership took in a lot of investor money, gained a $9 billion valuation, got Safeway and Walgreens as partners (now rescinded)–never proving that Theranos’ tests would do what they said they would do.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

Ransomware alert up in US, Canada: more details

April 3, 2016 | by

Ransomware threats are now the subject of a joint alert in both the US and Canada, with at least 14 hospitals under attack on both sides of the border. Ten of the hospitals are part of MedStar in Maryland [TTA 26 March, updated], and as your Editors have noted, it’s not just hospitals but also Mac iOS under attack and now, reportedly, even police and cafes (Telegraph.uk, NPR). $24 million was lost to ransomware in 2015 in the US alone, according to the FBI. Healthcare IT News reports a new variation called PowerWare which is delivered through MS Word documents, but goes further than Locky in mimicking legitimate files and activities without writing new files on the system, which makes it hard to detect. It invades PowerShell which is used by system admins for task automation and configuration management.

If you are catching up and want a useful overview, see Wired. The headline states the obvious, at least to this Editor. Hospitals and their often-flawed IT managed by overworked staffs are the perfect target for ransomware and multiple viruses as lives are at stake, not widget production. Like most malware and internet Bad Things, ransomware originated in Eastern Europe (where else?) back in 2005. Most attacks include instructions on how to access bitcoin, the untraceable payment method demanded by the hospital hostage-takers.

How to prevent or mitigate? NPR cites Peter Van Valkenburgh, director of research at Coin Center, a digital currency advocacy non-profit, that hospitals can take safeguards including HTTPS encryption, two-factor authentication and implementing file backups on a separate server.

Artificial pancreas for Type 1 diabetics may be closer

April 3, 2016 | by

A victory in this perpetual Battle of Stalingrad? Three universities, plus Dublin-based Medtronic, are developing devices that may bring a commercial artificial pancreas for Type 1 diabetics to market within the next few years. Medtronic is estimating that their system could be in market by 2017. The University of Virginia‘s Center for Diabetes Technology has a final clinical trial this summer on the inControl system which is being commercialized by start-up company TypeZero Technologies. Other research programs are underway at Cambridge University and Boston University, on a product that will measure both insulin and glucagon. Type 1 diabetics produce no insulin, making their lives literally dependent on close glucose monitoring and correct insulin delivery. These are “closed-loop” systems, consisting of a pump worn outside the body, a continuous glucose monitor, which measures glucose from fluid under the skin, and a device that runs continuous algorithms to determine insulin delivery. Much of this research has been funded by the Juvenile Diabetes Research Foundation (JDRF). Perhaps there will be a better and safer way soon to fight this perpetual Battle of Stalingrad for those with Type 1 diabetes. CNBC

Some New York-area events of interest April-May

April 3, 2016 | by
[grow_thumb image=”https://telecareaware.com/wp-content/uploads/2016/04/iCAN-Global-EBF-logo.jpg” thumb_width=”150″ /]Long-time Reader Howard Reis of telemedicine and teleradiology consultancy HEALTHePRACTICES  has advised us of two free and related events in the Westchester (NY metro) area of interest to entrepreneurs. Both are 21 April at the BioInc Incubator at Westchester Medical College, Valhalla NY.

The first is the bi-monthly iCAN NY breakfast from 8:30 to 10:30 am with the overall topic of commercialization of technologies, with talks from Mr Reis on industry healthcare trends and Michael and Stanley Goldstein from law firm Becker & Poliakoff on corporate governance. Registration via email to Les Neumann, iCAN NY managing director, at les@icanny.net.

The second is a half day ‘Pitch to the Angels’ sponsored by Westchester Angels and Westfair Communications starting at 9:30am through lunch closing at 1:30pm for local entrepreneurs (Westchester and Fairfield counties). It is a two-part event open to startups, entrepreneurs, investors and spectators. You can sign up for the morning or the lunchtime session, or both. Three or four businesses will be pitching in the pm session. Information here. Registration here. Interested in pitching? Submit to be considered here but hurry–it closes 8 April. Contact is Danielle Brody at dbrody@westfairinc.com.

d.Health Summit on 4 May at the NY Academy of Sciences in NYC is focusing this year on a worthy topic, ‘Aging in Place.’ There’s a roster of speakers from the usual journalist, payer and academic suspects, perhaps too many for one day, for your $695 registration. Unfortunately your locally-based Editor, after several fruitless attempts to contact the organizers, cannot offer any further information beyond the website or an endorsement.

Having attended the much-touted MUSE-Klick Health NY evening soireé this past Wednesday, which attempted to be over the top (High Line District! Industrial Converted to Art Space!), it wound up being uninspiring (except for 18 year old Claire Wineland, a young CF patient), barely health-oriented and embarrassingly self-referential. Circulation’s non-emergency health transportation for the 3.6 million Americans who miss medical appointments weekly due to lack of transport, beside a good idea, also had a pretty cool Mini Clubman on display. I left at the break in search of the previous two hours+ spent (at the end of a busy day in a busy week). Caveat emptor increasingly applies to events, yes?