News roundup: CVS cashing out notes, catching up with ISfTeH, India’s Stasis Labs RPM enters US, Propeller inhaler with Novartis Japan, Cerner gets going with VA

CVS Health is pricing out a tender offer for some notes. If you are holding one of a potpourri of notes with due dates of 2023 and 2025 from CVS, the company is making a cash tender offer, meaning they are cashing these notes out. This is usually done as part of rearranging financing, especially appropriate in the wake of the Aetna acquisition. The details are here in their release of 12 August. The collective value for both note years is approximately $3 bn each. An update is here on Seeking Alpha.

We have been remiss in not maintaining our following the Swiss-based International Society for Telemedicine and eHealth (ISfTeH) so we will direct your attention to their August update which features the effect of COVID on teledermatology, women’s health, teleurology, and news on members and developers. Their Journal, still edited by Professor Maurice Mars of South Africa, has published once this year in January.

India’s Stasis Labs, developer of a remote patient monitoring (RPM) platform utilizing a smartphone, vital signs devices, a bedside monitor connected into a platform, is entering the US market. It monitors six vital signs in a single monitor: heart rate, blood oxygen, electrocardiogram, respiratory rate, blood pressure, and temperature. Awarded a 510(k) clearance in April, Stasis, out of the Cedars-Sinai Accelerator program, has had a limited deployment at Texas-based emergency-care provider Hospitality Health ER and California-based Glendale Surgical Center and Orthopedic Surgery Specialists. It has also deployed to 50 cities in India. Mobihealthnews

Smartphone-connected inhaler sensor company Propeller Health has inked a deal with Novartis in Japan. Patients prescribed Novartis’ drugs for uncontrolled asthma, the Enerzair or Atectura Breezhaler, can now enroll in Propeller’s digital-management program. Data about their inhaler use will be transmitted from the sensor on the inhaler to Propeller’s smartphone app. The app also pings users with reminders and usage data. Propeller was acquired last year for a stunning $225 million by ResMed. Propeller this past May gained 510(k) FDA clearance for a sensor/app for use with AstraZeneca’s Symbicort inhaler.

Cerner’s EHR implementation with the US Department of Veterans Affairs finally took a step forward after many delays with the launch last Friday of a new scheduling system at the VA Central Ohio Healthcare System in Columbus, Ohio. Cerner migrated the information of some 60,000 veterans in preparation. The full EHR at the Mann-Grandstaff VA Medical Center in Spokane, Washington, originally scheduled for March, will go live this fall. Healthcare Dive

News roundup: LabCorp CRO boosts Medable, Propeller Health gains 510(k), EU’s 34 medtech startups, Amazon’s healthcare moves, Google’s Arizona privacy lawsuit

It does seem ages since our last one! One major winning category for digital health is clinical trials. LabCorp has one of the largest CROs (contract research organization), Covance. LabCorp has partnered with startup Medable, a Palo Alto-based company that decentralizes the gathering and analysis of clinical trial data from recruited participants through apps and telemedicine. Mobihealthnews  Confirming this trend: earlier this month, Medable cleared a $25 million venture round from GSR Ventures. Crunchbase  This does make rival CRO PRA Health Science’s pickup of Care Innovations from Intel late last year, for an undisclosed amount, look like a prescient (and likely a bargain) purchase.

Propeller Health, which specializes in digital respiratory health with sensors connected to inhalers and apps, gained 510(k) FDA clearance for a sensor/app for use with AstraZeneca’s Symbicort inhaler. This medication is used for asthma and COPD. It does not seem that long ago (2014) that the startup was at trade shows like NYeC and mHealth Summit with an exceedingly modest display of popups and brochures. Their 2019 acquisition by ResMed for the stunningly premium price of $225 million made news in late 2018. Mobihealthnews

In Europe, COVID-19 has boosted at least 34 medtech startups, including 11 in UK alone, followed by Switzerland and Sweden. This is based on a study by Oxford University data visualization spin-out Zegami. One of them happens to be Zegami on a project in using a limited dataset to distinguish between x-rays of COVID-19 infections and infections caused by viral or bacterial pneumonia, as well as images of healthy lungs. On the list are (naturally) Babylon Health and the slightly mysterious Medopad. Sweden’s Kry (LIVI in the UK) is also on the list. Kry/LIVI last made some news when Juliet Bauer of NHS Digital ankled to Kry in early 2019, Med-techInnovationNews, Mobihealthnews

Amazon’s latest stretches into healthcare are noted in a brief Becker’s Health IT article which notes AWS’ deals with Cerner and addition of healthcare-specific features with hospitals using AWS. Mayo Clinic has partnered with Alexa for voice responsive ‘Mayo Answers’. Some Amazon employees now have access to telehealth benefits (this Editor wonders why not all, beyond those Seattle warehouse workers). Industry research company CB Insights is projecting that Amazon’s next move will be a benefits marketplace for employers and payers. Meanwhile, their partnership with JP Morgan Chase and Berkshire Hathaway, Haven, has stumbled with its CEO Atul Gawande, MD, leaving the post to return to practice after less than two years. Executive turnover has been high, and the company has yet to announce a major initiative. FierceHealthcare 

Meanwhile, Arizona’s attorney general has sued Google for violating state privacy laws. Seems like Android users are trackable, even if they turn off location on their phones, through Google apps like Maps and Weather. The lawsuit also charges that Google changed its default tracking settings without informing users, using data for targeted ads. Becker’s Health IT 

Where’s the evidence? Healthcare unicorns lack the proof and credibility of peer-reviewed studies.

Another sign that too many healthcare unicorns are decoupled from the rock-solid fundamental reality–that they work. Healthcare unicorns–those startups valued over $1 bn–are unicorns because they have patents, processes, or a line of business that has immense potential to be profitable. The standard in healthcare, unlike other tech, is the peer-reviewed study. Is this process or device effective based upon the study? Does this drug looks like it will work? Is this study validating, encouraging? Peer-reviewed research takes place before a drug or device goes into clinical trials — a precursor. It ensures a certain level of disclosure, validation, and transparency at an early stage.

Instead, these unicorns largely rely on ‘stealth research’–a term coined by Dr. John P.A. Ioannidis, the co-director of the Meta-Research Innovation Center at Stanford University (METRICS). He summed it up in his latest peer-reviewed paper, “Stealth research: lack of peer-reviewed evidence from healthcare unicorns” (co-authored with Ioana A. Cristea and Eli M. Cahan), published in the European Journal of Clinical Investigation 28 Jan: 

In 2014, one of us (JPAI) wrote a viewpoint article coining the term “stealth research” for touted biomedical innovation happening outside the peer-reviewed literature in a confusing mix of “possibly brilliant ideas, aggressive corporate announcements, and mass media hype.”

The term ‘stealth research’ was prompted to the author by the practices of Theranos–ironically, a company that started and was funded in the Stanford nexus. By the time Dr. Ioannidis’ viewpoint paper was published in JAMA in Feb 2015, Theranos had ballooned to a $9 bn valuation. His paper was the first to question Theranos’ science–and Theranos aggressively pushed back against Dr. Ioannidis, including their general counsel attempting to convince the author to recant his own writing. Three years later, we know the outcome.

This latest study concludes that there is a real dearth of peer-reviewed research among healthcare unicorns–and that it’s detrimental. It measured whether these unicorns published peer-reviewed articles and whether they publish highly-cited (in other publications) articles; compared them against companies with lower valuations; and whether founders or board members themselves impacted the scientific literature through their own citations.

The meta-study looked at 18 current and 29 exited healthcare unicorns. Highlights:

  • Two companies–23andMe and Adaptive Biotechnologies published almost half of all unicorn papers–196 combined
  • Three unicorns (Outcome Health, GuaHao and Oscar Health) had no published papers, and two more (Clover Health, Zocdoc) had published just one
  • Seven of the exited unicorns had zero to one papers
  • In fact, ‘there was a negative, non-statistically significant association between company valuation and number of published or highly-cited papers’

As our Readers know, Outcome Health had a little problem around artificially inflated advertising placement wrapped in health ed and placed in doctors’ offices [TTA 29 Jan 18]. Oscar and Clover Health are insurers. Zocdoc…well, we know their business model is to get as many doctors to sign up in their scheduling app and pay as much as possible. But it’s the drug and device companies that are especially worrisome in a stealth research model. The paper points out among other examples StemCentrx, bought for $10.2 bn in 2016 by AbbVie for its Rova T targeted antibody drug for cancer treatment, was halted at Phase III because it was not effective. Acerta Pharma, also focused on cancer treatments, was bought by AstraZeneca for $7.3 bn; two years ago, AstraZeneca had to withdraw the Acerta data and admit that Acerta falsified preclinical data for its drug.

The conclusions are that healthcare unicorns contribute minimally to relevant, high-impact published research, and that greater scrutiny by the scientific community through peer-reviewed research is needed to ensure credibility for the underlying work by these startups. “There is no need for numerous papers. Discrete pivotal, high-impact articles would suffice.”

This Editor returns to #5 on Rock Health’s Bubble Meter: high valuations decoupled from fundamentals. Based on this, the lack of publishing represents risk–to investors and to patients who would benefit from better vetted treatments. To these companies, however, the risk is in having their technology or researched poached–as well as the investment in time and money research represents.

The study authors point out several ways to minimize the risk, including collaborating with academic centers in research, validation without disclosing all technical details, secure patents, and contributing their technology to other research. A higher-risk way is to “withhold significant publications until successful validation from agencies such as the Food and Drug Administration (FDA) or the European Medicines Agency (EMA)” but usually investors won’t wait that long. ‘Stealth Research’ paper, TechCrunch review Hat tip to David Albert, MD, of AliveCor via Twitter

AstraZeneca awards over $200k for heart failure telehealth

AstraZeneca Healthcare Foundation, the charitable arm of the UK based pharmaceutical company AstraZeneca, has awarded $205,564 to HSHS St. John’s Hospital in Illinois to support their Tele-Heart Pathway programme. [grow_thumb image=”http://telecareaware.com/wp-content/uploads/2015/02/HSHS.jpg” thumb_width=”150″ /]The programme provides interventions to heart failure patients in their homes to support health management. With telemedicine and telehealth technology doctors monitor symptoms and help avoid complications at home after surgery, according to the hospital.

 “We have seen a rapid evolution in the last few years of new devices and new ways of communicating with our patients,” said Mark Stampehl, MD and Medical Director of the heart failure programme at Prairie Heart Institute (PHI) at St. John’s Hospital, in an article entitled Telemedicine elevates care for heart patients published in the fall 2014 issue of the hospital’s quarterly magazine Healthy You. “Today, we are using tools to remotely monitor a patient’s condition and increase communication with other physicians to give patients access to specialty care from home.” (more…)

Medtronic, Covidien and what it might mean for digital health

“This acquisition will allow Medtronic to reach more patients, in more ways and in more places,” Medtronic Chairman and CEO Omar Ishrak

Cover the Earth? While the healthy Medtronic offer ($42.9 billion in cash and stock) for Ireland-headquartered Covidien plc is not a ‘digital health deal’, it does point to Medtronic’s strategy which includes digital health. There is of course the obvious: growth by acquisition and integration. Acquisitions require cash, and the highly controversial change of domicile to Ireland via ‘tax inversion’ will fatten the exchequer in two ways. First is through the lower overall Irish corporate tax versus the 35 percent US tax, one of the highest in the world. Second is much more flexibility in repatriating plentiful foreign earnings at lower Irish corporate rates rather than the high US rates which Medtronic has avoided. Third is increasing dividends, which can drive up stock price and investor interest. Of interest to the latter is also that Covidien adds horizontal (and global) competitive strength to Medtronic in the clinical area–surgical, vascular, respiratory and wound care.

More Ways-More Places. Not just staples and sutures, Covidien has developed its own advanced in-hospital mobile patient monitoring in Vital Sync as well as several hospital monitoring devices in their Nellcor line. In addition to technology collaboration, the next point of integration could then be with Medtronic’s post-acute telehealth devices from Cardiocom, purchased less than one year ago. We noted at the time that it gave Medtronic entreé into the “chronic condition management continuum– not only into telehealth via Cardiocom’s devices and hubs, but also their clinical and care management systems.”

Approval will take time. Both the US and UK, through various regulatory agencies, scuppered the Pfizer-AstraZeneca deal on similar tax domiciling and competitive grounds. If it does go through, there will be a lot of reorganization. But while it digests, this Editor will be watching Medtronic for its usual pattern of making smaller ‘more ways/more places’ deals in the interim with an eye to diversifying past US-taxable medical devices. One pointer is their just-announced partnering with Sanofi to develop drug delivery-medical device combinations and care management services for diabetes patients (MedCityNews).

Related reading: Medtronic hints at more acquisitions following $43 billion Covidien deal (MedCityNews); The Medtronic, Covidien Inversion Deal Is More About Dividends Than Tax (Forbes); Medtronic agrees to buy Covidien for $42.9b in cash, stock (Boston Globe); Medtronic’s $43B Covidien deal—and Irish tax move (CNBC)

 

Vodafone and AstraZeneca sign global m-health partnership

Vodafone has signed a global partnership with AstraZeneca in order to develop m-health services to improve the outcome for patients with cardiovascular conditions. The collaboration will create new mobile and internet-based services to support patients through their treatment journey, improving medication adherence and giving patients confidence to manage their condition more effectively, according to the press release.

AstraZeneca’s Intelligent Pharmaceutical Group will lead the project with Vodafone charged with providing the technology, infrastructure and expertise for the new services.

The UK-based operator said it will also look to capture data from a variety of sources to improve overall engagement between patients and healthcare professionals. All the new services will be designed to work across geographies.

“Bringing together the best in connectivity with the best in treatment and education will create powerful and compelling outcomes for patients,” according to a comment attributed to Vodafone M2M Director Erik Brennais. But there is little in the way of details of what the two companies may develop or the timescales.

So many apps, so little time

Over the past few days there seems to have been a particularly rich set of alerts related to mHealth apps (there’s even been an update to the mHealth Grand Tour website with a nice video to promote the tour that starts on 5th September). Adding to them a couple that others have kindly alerted me to, here are a few that might interest:

Let’s begin with an infographic on the rising popularity of mHealth apps that puts it all into context. However, in some countries mHealth is being held back by outdated privacy laws, and in the US lack of final FDA guidance is considered a check on progress.  If you ever wondered how much data your DNA, or your most recent scan contained, (more…)