CVS-Aetna merger will run off the tracks in Federal court: reports

Reports emerging this past Monday after the close of last week’s DC Federal District Court hearings in indicate that the CVS-Aetna merger may be nixed by Judge Richard Leon. This may result in the full unwinding of the already-closed merger, a derailing of the settlement which involved selling the Aetna Medicare Part D business to government-plan insurer WellCare, or something in between.

The original report was in Monday’s New York Post. A source working with CVS and Aetna stated “I think Leon rules against us. If he rejects the settlement, we would have to figure out the next steps.” That settlement is significant because it represents the only major overlap between the CVS and Aetna businesses. In other words, there’s nothing left to divest or concede.

Judge Leon, based on reports, was consistently irritated with the Department of Justice, questioning everything from the Part D divestiture to the effects of adding 21 million Aetna customers to CVS’s pharmacy benefits management (PBM) business not being revealed in DOJ documents to him. Conversely, the sale of the Part D business to WellCare was batted one way–as not enough to reduce CVS’ market control and not competitive–and then the other, as WellCare remains a CVS PBM customer for 2.2 million members in its health plans. What was also clear from his selection of expert witnesses that Judge Leon was more interested in the anti-competitive effects of the merger than any of the benefits.

It is obvious both from Judge Leon’s in-court actions (such as not permitting DOJ attorneys to cross-examine any witnesses), assorted remarks, and delay for now over six months, that this merger is coming to a pre-ordained conclusion, at least by this judge. This is already a first under the Tunney Act enacted in 1974. A negative decision will certainly be appealed by CVS-Aetna and DOJ, which will drag out any finalization even if successful–and the sale of the Part D business, important to WellCare as part of its own pending acquisition by Centene–to the end of the year and possibly beyond.

With this background and oral arguments delayed until 17 July, according to Judge Leon, the legal teams on all sides won’t have much of a summer.  Also Barrons, video on NBR.

Digital health: why is it a luxury good in a world crying for health as a commodity?

Why digital health still struggles to find its stride. Those of us in the healthcare field, especially Grizzled Pioneers, have been wondering for the past decade why Digital Health’s Year is always Next Year. Or Next Decade. 

Looking back only to 2000, we’ve had 9-11, a dot-com bust, a few years in between when the economy thrived and the seed money started to pollinate young companies, a prolonged recession that killed off many, and now finally a few good economic years where money has flooded into the sector, to good companies and those walking the fine line of mismanagement or fraud. We’ve seen the rise/fall/rise of sensors, wearables, and remote monitoring, giants like Google and Microsoft out and back in, the establishment of EHRs, acceptance by government and private payers, quite a bit of integration, and more. All one has to look is at the investment trends breaking all records, with funding rounds of over $10 million raising barely a notice–enough to raise fears of a bubble. Then there’s another rising tide–that of cyberattack, ransomware, insider and outsider hacking.

Is it this year? It may not be. Despite the sunshine, interoperability holds it all back. Those giant EHRs–Cerner, Epic, Athenahealth, Allscripts–are largely walled gardens and so customized by provider application that they barely are able to talk to their like systems. There are regional health exchanges such as New York’s SHIN-NY, Maryland’s CRISP, and others, but they are limited in scope to their states. The VA’s VistA, the granddaddy of the integrated system, died of old age in its garden. Paul Markovich, CEO of Blue Shield of California cites the lack of interoperability and being able to access their personal health data as a major barrier to both patients and to the large companies who want to advance AI and need the data for modeling. (China and its companies, as we’ve noted, neatly solve this problem by force. [TTA 17 Apr]) Apple is back in with Health Records, but Mr. Markovich estimates it may take 10 years to gather the volume of data it needs to establish AI modeling. Some wags demand that Apple buy Epic, as if Epic was up for sale. BSC, like others, is testing interoperability workarounds like Notable, Ooda Health, and Manifest MedEx. Mr. Markovich cites interoperability and scaling as reasons why healthcare is expensive. CNBC

And what about those thriving startups? Hold on. During the Google Cloud/Rock Health 3 June event, one of the panelists–from Partners HealthCare, which works both side of the street with Pivot Labs–noted that hospitals have figured out their own revenue models, and co-development with hospitals is key. Even if validated, not every tech is commercially ready or lowers cost. And employers are far worse than hospitals at buying in because they ultimately look at financial value, even if initially they adopt for other reasons. In addition, the bar moved higher. The new validation standard is now provider-centric–workload, provider satisfaction, and implementation metrics, because meeting clinical outcomes is a given. Mobihealthnews

And still another barrier–data breaches and cyberattack–is still with us, and growing. Quest Diagnostics’ data breach affects nearly 12 million patients. It was traced to an individual at a vendor, American Medical Collection Agency, and it involved Optum360, a Quest contractor and part of healthcare giant Optum. The unauthorized person had access to the network for eight months – between 1 August 2018, and 30 March 2019–and involved both financial and some health records. Quest now is in the #2 slot behind the massive 79 million person Anthem breach, which, based on a Federal grand jury indictment in Indianapolis in May, was executed by a Chinese group in 2015 using spearfishing and backdoors that gathered data and sent it to China. There were three other US businesses in the indictment which are not identified. Securing health data is expensive — and another limitation on the cost-lowering effects of interoperability. Healthcare IT News

Digital Health’s Year, for now, will remain Next Year–and digital health for now will remain fractional, unable to do much to commoditize healthcare or lower major costs.

The CVS-Aetna hearing is on the move–finally

The train that is the CVS-Aetna hearing, in the courtroom presided over by Judge Richard Leon of the US District Court for the District of Columbia, is at long last chugging down the tracks. And Pauline is still tied up. Tuesday 4 June was Day 1 of this hearing. Early reports are just being filed. The issue is whether Judge Leon will authorize the Department of Justice’s approval of the merger or dissolve a closed merger, based on his authority under the Tunney Act and his own repeated intent to search for harm that the merger might do to the public. 

Today’s hearing focused on Aetna’s divestiture of its Medicare Part D business as a prelude to the merger, and whether it was quite enough. Much of the discussion was on the relative strength of the buyer, WellCare (itself in the early stages of being acquired), and whether it could be truly competitive in the Part D market. The other factor is that CVS as a dominant pharmacy benefits manager (PBM) could undermine WellCare in several ways. PBMs operate opaquely and are highly concentrated, with CVS, Optum (UnitedHealthcare), and Cigna-Express Scripts accounting for 70 percent of the market. Modern Healthcare

Other issues for Days 2 and 3 will cover the effects on competition in health insurance, retail pharmacy and specialty pharmacy.

Healthcare Dive discusses how these hearings are already setting precedent on how Tunney Act hearings are conducted, their scope (Judge Leon has ruled against every attempt by CVS-Aetna to limit it), and the unprecedented live testimony.  There is the good possibility that Judge Leon will decide to dissolve the merger for competitive reasons, which DOJ likely would appeal. Add to this the cost of the delayed integration and the precedent set by the District Court on scrutiny of any healthcare merger, and this tedious hearing along with Judge Leon’s actions leading to it hold major consequences.

China’s getting set to be the healthcare AI leader–on the backs of sick, rural citizens’ data privacy

Picture this: a mobile rural health clinic arrives at a rural village in Jia County, in China’s Henan province. The clinic staff check the villagers, many of them elderly and infirm from their hard-working lives. The staff collect vital signs, take blood, urine, ECGs, and other tests. It’s all free, versus going to the hospital 30 miles away.

The catch: the data collected is uploaded to WeDoctor, a private healthcare company specializing in online medical diagnostics and related services that is part of Tencent, the Chinese technology conglomerate which is also devoted to AI. All that data is uploaded to WeDoctor’s AI-powered cloud. The good part: the agreement with the local government that permits this also provides medical services, health insurance, pharmaceuticals and healthcare education to the local people. In addition, it creates a “auxiliary treatment system for general practice” database that Jia County doctors can access for local patients. According to the WIRED article on this, it’s impressive at an IBM Watson level: 

Doctors simply have to input a patient’s symptoms and the system provides them with suggested diagnoses and treatments, calculated from a database of over 5,000 symptoms and 2,000 diseases. WeDoctor claims that the system has an accuracy rate of 90 per cent.

and 

Dr Zhang Qiaofen, in nearby Ren Zhuang village, says the system it has made her life easier. “Since WeDoctor came to my clinic, I feel more comfortable and have more confidence,” she says. “I’m thankful to the device for helping me make decisions.”

The bad part: The patients have no consent or control over the data, nor any privacy restrictions on its use by WeDoctor, Tencent, or the Chinese government. Regional government officials are next pictured in the article reviewing data on Jia County’s citizens: village, gender, age, ailment and whether or not a person has registered with a village health check. Yes, attending these health checks is mandatory for the villagers. 

What is happening is that China is building the world’s largest medical database, free of those pesky Western democracy privacy restrictions, and using AI/machine learning to create a massive set of diagnostic tools. The immediate application is to supplement their paucity of doctors and medical facilities (1.5 doctors per 1,000 people compared to almost double in the UK). All this is being built by an estimated 130 private companies as part of the “Made in China 2025” plan. Long term, the Chinese government gets to know even more intimate details about their 1.3 billion citizens. And these private companies can make money off the data. Such a deal! The difference between China’s attitude towards privacy and Western concerns on same could not be greater.  More on WeDoctor’s ambitions to be the Amazon of healthcare and yes, profit from this data, from Bloomberg. WeDoctor is valued at an incredible $5.5 billion. Hat tip to HISTalk’s Monday morning update.

A telemedicine ‘robot’ delivers end of life news to patient: is there an ethical problem here, Kaiser Permanente?

Bad, bad press for in-hospital telemedicine. A 78 year-old man is in the ICU in a Kaiser Permanente hospital in Fremont, California. He has end-stage chronic lung disease and is accompanied by his granddaughter. A nurse wheels in an InTouch Telemedicine ‘robot’ (brand is clearly visible on the videos; KP is one of their marquee customers). The mobile monitor screen is connected to a live doctor on audio/video for a virtual consult. The doctor is delivering terminal news: that not much can be done for Mr. Quintana other than to keep him comfortable in the hospital on a morphine drip, and that he would likely be unable to return home to hospice care.

Granddaughter Annalisia Wilharm videoed the consult. The screen is high above the bed, the doctor is wearing headphones, and is looking down. The doctor’s voice is accented and hard to understand through the speakers–is the volume low because it’s set low or due to privacy regulations? In any case, the doctor is asked time and again to repeat himself by the granddaughter as the patient cannot hear or understand the doctor. Another factor apparent on the video to this Editor is that the patient is on a ventilator–and ventilators make noise that mask other sounds.

Mr. Quintana passed away in the hospital last Tuesday 5 March, after a two-day stay.

The video has gone viral here in the US, with the family going to local press first (KTVU). The story was picked up in regional Northern California coverage and blew up into national coverage from USA Today (edited video complete with emotive background music), Fox News (San Jose Mercury News video), and picked up in media as diverse as the Gateway Pundit–if you want to get a feel for vox populi, see the comments.

Kaiser Permanente has apologized in guarded terms: “We offer our sincere condolences,” said Kaiser Permanente Senior Vice-President Michelle Gaskill-Hames. “We use video technology as an appropriate enhancement to the care team, and a way to bring additional consultative expertise to the bedside.” Also: “The use of the term ‘robot’ is inaccurate and inappropriate,” she exclaimed. “This secure video technology is a live conversation with a physician using tele-video technology, and always with a nurse or other physician in the room to explain the purpose and function of the technology. It does not, and did not, replace ongoing in-person evaluations and conversations with a patient and family members.” The family also was well aware of Mr. Quintana’s status but is equally upset at his treatment at this critical time.

Despite all this exclaiming, this Editor, an advocate of innovations in telemedicine and telehealth since 2006, finds fault with Kaiser Permanente’s deploying a telemedicine consult in this situation on the following grounds:

  • End-of-life news this serious needs to be delivered by a human. Period.
  • Despite Ms. Gaskill-Hames’s statement, the video consult was not intermediated by a human. There is someone in scrubs behind the InTouch mobile monitor, but there is no standing by the monitor nor any effort to interpret what the doctor is saying. Explaining the technology is not explaining what the patient and family can do.
  • The patient had difficulty understanding the doctor’s voice, either through hearing or language comprehension. A ventilator could be blocking or masking the audio. Even so, the audio, depending on the source, is muddy, and the video worse than you get on a smartphone. 
  • The monitor is at the foot of the bed, not close to the patient. The patient may not be able to see the monitor at that distance due to poor vision.
  • It doesn’t take much thought to believe there may be an issue of cultural inappropriateness.
  • There is no patient advocate or a chaplain present. Whether one visited later is not known.
  • Another open question: why was additional comfort care and a ventilator not available at home if Mr. Quintana was truly terminal? Did this man die needlessly in an ICU?

The popular takeaway about Kaiser, the VA, and other health systems which are deploying telemedicine by their patients is that robots are replacing doctors. We may know better, but that is what the consumer press runs with–an emotional video that, BTW, breaks patient-doctor confidentiality by showing the (unnamed, but not for long) doctor giving medical instructions to Mr. Quintana.

It is not the telemedicine technology, it is how it is being used. In this case, with insensitivity. The blame will be laid, in this shallow time, at the feet of the ‘robot’. Rightly, blame should also be laid at the feet of the increasingly ‘robotic’ practices of major health systems.

There will certainly be more to this story.

A view at some variance, but winding up in the same place, is expressed by Dr. Jayne in HIStalk.

About time: digital health grows a set of ethical guidelines

Is there a sense of embarrassment in the background? Fortune reports that the Stanford University Libraries are taking the lead in organizing an academic/industry group to establish ethical guidelines to govern digital health. These grew out of two meetings in July and November last year with the participation of over 30 representatives from health care, pharmaceutical, and nonprofit organizations. Proteus Digital Health, the developer of a formerly creepy sensor pill system, is prominently mentioned, but attending were representatives of Aetna CVS, Otsuka Pharmaceuticals (which works with Proteus), Kaiser Permanente, Intermountain Health, Tencent, and HSBC Holdings.

Here are the 10 Guiding Principles, which concentrate on data governance and sharing, as well as the use of the products themselves. They are expanded upon in this summary PDF:

  1. The products of digital health companies should always work in patients’ interests.
  2. Sharing digital health information should always be to improve a patient’s outcomes and those of others.
  3. “Do no harm” should apply to the use and sharing of all digital health information.
  4. Patients should never be forced to use digital health products against their wishes.
  5. Patients should be able to decide whether their information is shared, and to know how a digital health company uses information to generate revenues.
  6. Digital health information should be accurate.
  7. Digital health information should be protected with strong security tools.
  8. Security violations should be reported promptly along with what is being done to fix them.
  9. Digital health products should allow patients to be more connected to their care givers.
  10. Patients should be actively engaged in the community that is shaping digital health products.

We’ve already observed that best practices in design are putting some of these principals into action. Your Editors have long advocated, to the point of tiresomeness, that data security is not notional from the smallest device to the largest health system. Our photo at left may be vintage, but if anything the threat has both grown and expanded. 2018’s ten largest breaches affected almost 7 million US patients and disrupted their organizations’ operations. Social media is also vulnerable. Parts of the US government–Congress and the FTC through a complaint filing–are also coming down hard on Facebook for sharing personal health information with advertisers. This is PHI belonging to members of closed Facebook groups meant to support those with health and mental health conditions. (HIPAA Journal).

But here is where Stanford and the conference participants get all mushy. From their press release:

“We want this first set of ten statements to spur conversations in board rooms, classrooms and community centers around the country and ultimately be refined and adopted widely.” –Michael A. Keller, Stanford’s university librarian and vice provost for teaching and learning

So everyone gets to feel good and take home a trophy? Nowhere are there next steps, corporate statements of adoption, and so on.

Let’s keep in mind that Stanford University was the nexus of the Fraud That Was Theranos, which is discreetly not mentioned. If not a shadow hovering in the background, it should be. Perhaps there is some mea culpa, mea maxima culpa here, but this Editor will wait for more concrete signs of Action.

The Theranos Story, ch. 58: with HBO and ABC, let the mythmaking and psychiatric profiling begin! (updated)

This Editor thought that her next articles about Theranos would be trial coverage. There are court dates pending for Elizabeth Holmes and Not-So-Sunny Balwani–with the DOJ for 11 counts of wire fraud [TTA 16 June] and, for Mr. Balwani, with the SEC on (civil) securities fraud [TTA 15 March]. 

Instead, Theranos hits the headlines again. On 18 March, there’s the debut of an HBO documentary on Theranos. Titled The Inventor: Out For Blood In Silicon Valley (YouTube preview), we can treat ourselves once again to the SteveJobs-esque presence of Ms. Holmes, down to the unnaturally deep voice, blondined hair, and wide blue eyes, unpacking the deception and fraud that was part of the company from early days. But that’s not all! There’s a six-part ABC Radio ‘Nightline’ docu-podcast that started on 23 Jan and airs in six parts through February, which includes audio of depositions taken of board members, whistleblower Tyler Shultz, and patients affected by bad test results. (This Editor will give a listen on this alone.) Episode 5 and links to 1-4 are here via Yahoo.

On websites, we’re regaled with rehashes. The articles range from Teasing the Doc to Where The Ex (Balwani) Is Now (they don’t know) to What Is Her Net Worth (not $4.6 bn). There’s even a flurry of sensational podcasts and videos on YouTube–just Google them. 

Fascinating Fraud. There’s fascination in The Long Con perpetrated by the principals, and less examined, our tendency to Want To Believe. Many of us like legal procedurals and the drama inherent in them (the eternal appeal of the long-running Law & Order in several countries.) Let’s face it, there’s a substantial dollop of schadenfreude mixed in.

What we are witnessing is the building of a myth, increasingly divorced from the real world where it happened, and not improbably or with superpowers. 

Where it goes a little off the cliff. There is a curious article in Forbes that is written by a contributor who writes and teaches courses on stocks and entrepreneurship. He interviewed a former neighbor of Ms. Holmes, Richard Fuisz, MD. It turns out this psychiatrist, inventor, and former CIA asset knew her in childhood. The families were friends and Dr. Fuisz helped out her father when he hit a bad patch. There’s some sketchy profiling in this article, but it does make a fair attempt to get to the heart of the forces that put the gap in Elizabeth Holmes’ ethical makeup, including the Big Steal of Ian Gibbons’ IP. His position is somewhat complicated by a patent dispute (settled) between Dr. Fuisz & Son and Theranos. He’s still hammering on at it on Twitter (@rfuisz).

What’s missing? Much credit to the estimable John Carreyrou, who broke the story in the Wall Street Journal and got his livelihood (and perhaps a few other things) threatened a few times by Tough Guy Lawyer David Boies.

(Updated) At least it is here in a Vanity Fair article on the Last Days of Theranos, where they had to move to downscale Newark (California) and Ms. Holmes’ dog pooped where he wanted to poop. Her ‘persecution’ doesn’t seem to faze her from living in SF, frequenting cafes with said dog, and her new romance with a ‘younger hospitality heir’–a far cry from her former employees who wear the months or years of their lives at Theranos like a Scarlet Letter as they look for work and loose cash in the sofa.

We’ve gotten to the point where the hard business analysis ends and the looser parts of psychologizing begins, as we attempt to understand why. Beyond a certain point, does why matter when damage to real patients has been done? Collateral damage persists in funding of startups and for entrepreneurial women in health tech.

For this Editor, she looks forward to the warmer weather, when it’s expected when the Legal Action–and reality–resumes. 

Roy Lilley’s tart-to-the-max view of The Topol Review on the digital future of the NHS

Well, it’s a blockbuster–at least in length. Over 100 pages long, and in the PDF form double-paged, which will be a tough slog for laptop and tablet readers. It’s Eric Topol’s view of the digital future of the NHS and it’s…expansive. In fact, you may not recognize it as the healthcare world you deal with every day.

Our UK readers may not be so familiar with Dr. Topol, but here you can get a good strong dose of his vision for the NHS’ future as delivered (electronic thunk) to Secretary Hancock. I haven’t read this, but Roy Lilley has. You should read his 12 February e-letter if you haven’t already.

Here is a choice quote: It’s a mixture of science faction, future-now-ism and away-with-the fairies.

Here’s some background. The Vision’s been around for awhile. Dr. Topol thinks and talks Big Picture, in Meta and MegaTrends. His view is patient-driven, self-managed, with their genomic sequenced and at their fingertips, with the doctor empowered by their records, his/her own digital tools for physical examination, with AI to scan the records and empower a partnership model of decision-making.

Topol In Person is quite compelling. This Editor’s in-person take from the 2014 NY eHealth Collaborative meeting is a review of vintage Topol. His expansive, hopeful view was in contrast to the almost totalitarian view (and it is fully meant) of Ezekiel Emanuel, with his vision of the perfectly compliant, low choice patient, and squeezed like a lemon medical system. At that time, I concluded:

One must be wary of presenters and ‘big thinkers’–and these doctors define the latter, especially Dr Emanuel who looks in the mirror and sees an iconoclast staring back. Fitting evidence selectively into a Weltanschauung is an occupational hazard and we in the field are often taken with ‘big pictures’ at the expense of what can and needs to be done now. Both Drs Topol and Emanuel, in this Editor’s view, have gaps in vision.

A year later, I reviewed his article The Future of Medicine Is in Your Smartphone which came out at the time of ‘The Patient Is In.’ which was quite the succès d’estime among us health tech types. “The article is at once optimistic–yes, we love the picture–yet somewhat unreal.” It seemed to fly in the face of the 2015 reality of accelerating government control of medicine (Obamacare), of payments, outcomes-based medicine which is gated and can be formulaic, and in the Editor’s view, a complete miss on the complexities of mental health and psychiatry.

Back to Roy Lilley:

There is an etherial quality to this report, spiritual, dainty. The advisory panel is 70 strong.

Studies and citations galore, from the world’s top research organizations. The advisory board–I believe well over 70–there’s not a soul down in the trenches running a hospital. Government, academics, and a few vendors (Babylon Health, natch). A lot of emphasis on AI, genomics, and training for ‘collective intelligence’. After reading but a few dizzying, dense pages, I admire the vision as before, but wonder again how we get from here to there.

Roy’s essay is a must read to bring you back to reality. 

Digital health versus eHealth: ‘here we go again’ with the confusion and the differences. Plus Women in eHealth (JISfTeH)

Editor Donna (and Editor Steve before her) always likes a good dust-up about terminology. One of the former’s pet peeves is the imprecise usage of telemedicine (virtual visits) versus telehealth (remote patient monitoring of vital signs); she will concede that the differences have been so trampled on that telemedicine has nearly faded from use.

The Journal of the International Society for Telemedicine and eHealth (JISfTeH) makes a grand attempt to parse the differing definitions of digital health and eHealth in their opening editorial of this month’s (24 Jan) issueeHealth has fallen so far from use that the few times one does see it is in associations such as ISfTeH and the New York eHealth Collaborative. Even the World Health Organization, which has always been a fair arbiter for the industry, defined eHealth back in the salad days of 2005 as “the use of Information and Communication Technologies (ICT) for health”–broad, but workable. After a witty aside in defining digital health as “an area of healthcare focused entirely on fingers and toes” (plus), and examining the overly broad definitions of Eric Topol and Paul Sonnier, the authors Richard E. Scott and Maurice Mars seem to settle on this: that while digital health is given a  much broader but nebulous definition (to the point of linguistic absurdity cited in Mesko et al.), and may incorporate related technologies like genomics (another poorly defined term) and ‘big data’, it would not work without that ICT. And that at least there’s a settled definition for eHealth, as stated above, for which this Editor assumes we should be happy. In the author’s closing, “Will we be sufficiently motivated to rise to such a challenge-globally agreed universal definitions? If not ……here we go again …..”

This month’s journal theme is also Women in eHealth, with articles on Brazilian eHealth distance education, digital technology in midwifery practice, and how online social networks can work for drug abuse treatment referral. There’s also a change in format, with article links opening to full PDFs of each article.

The telehealth ‘entrepreneur’ whose $5 million funding bought stays at the Ritz and portfolios at Bottega Veneta

This curious and cautionary tale should be better known. A young entrepreneur named Keisha L. Williams from Ashburn, Virginia had an attractive proposition. She needed immediate funding to bring to the US an Austrian telehealth system described as “software that would allow doctors to remotely examine and talk with patients.” Ms. Williams had degrees in both law and electrical engineering, so credibility. She also had a story. The software was in ‘escrow’ in Austria. There were taxes and fees that had to be paid immediately. And she had family situations, financial and medical emergencies. In other words, she had a ‘great line of ‘stuff’ on the technology, urgency, and personally, a few tugs on the heartstrings.

Ms. Williams told this story enough times over four years, and to enough people who believed her–more than 50, who invested over $5.4 million.

What happened? 95% of the money was spent on over the top vacations to Bora Bora, Italy, the Bahamas, and Jamaica, plus the occasional yacht with ‘hand and foot services’ and shopping at top-end retail such as Bottega Veneta and Vuitton. $500,000 alone was spent on her girlfriend. About $300,000 was spent on the software.

The rest of the story involves 14 Federal fraud charges, four accomplices, and unwitting, likely vulnerable people who were talked into giving over their savings. Late in January, she was sentenced to 15.5 years in Federal prison.

Many of our Readers have started companies or worked with entrepreneurs who have a great story and need money. The stories touch our hearts–and sometimes our checkbooks. Apparently, Ms. Williams raised the money without exposing herself to anyone in the industry or private investors who would ask remotely leading questions. To us, this technology sounds hardly sexy–it’s telemedicine virtual visit software with maybe some remote patient monitoring thrown in. Yet to 50 people, who are now poorer or who were involved with the fraudulent scheme — it sounded really special. (The name is also common–there are quite a few people on LinkedIn with the same name, which may make life difficult for them.)

With the rising tide of telehealth, if your cousin or uncle has heard of a great way to visit your doctor over the phone and asks you if you’ve heard about it, you might want to ask Uncle to pass the pie as you switch the conversation to being on guard for fraudulent schemes. Washington Post (read the comments), Daily Mail, Seattle Post-Intelligencer, press releases 17 Oct and 18 Jan from the US Attorney’s office, Eastern District of Virginia

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

It’s Official: CES is now a health tech event (updated)

CES is now, officially, a health tech event. It’s not just the timing before CES of the flashy but apparently cratering JP Morgan annual healthcare investment conference in the absurdly pricey venue of San Francisco (FierceBiotech on the #MoveJPM backlash; the general disillusion with it expressed well here). It’s the fact that whatever mainstreaming health tech has actually accomplished, it’s far better represented in Las Vegas. Always a place of beginnings, endings, fun, gambles taken, lack of sleep, and sore feet, health tech fits right in, big or small.

CES reported that 2019 boasted an increase of 25 percent health-related exhibitors and a 15 percent increase in the amount of floor space dedicated to health tech. One winner was a big gamble by a small company–Living in Digital Times, which organizes and stages the Digital Health SummitTen years later, it turned out to be right place, right time for the founders who work hard to keep it on trend. Lifestyle, robotics, self-care, assistive tech (even exoskeletons), wearables, cosmetic “wellness” devices like P&G’s Opté, and Alexa-type home assistants/robots all now fit into the CES purview. Trial balloons by young companies, AI-powered concept devices from big companies, watches (including the Apple-beater Move ECG from the revitalized Withings TTA 10 Oct 18 and Omron’s HeartGuide), and robots all appeared. Samsung again brought out a brace of concept robots. Last year’s Best of CES ElliQ is finally available for pre-order after three years at a measly $1,500. The humanoid Sophia brought a kid sister, the equally creepy Little Sophia, both of whom failed during this CNET video. Yes, Pepper from Softbank made its appearance and apparently didn’t wilt as it did last year.

Sleep tech was another hot item, with a spin on sleep diagnostics or improvement from many products. A brainwave product, Urgonight from France, claims to be able to train your brain to sleep better. (Send one to Rick Astley who was a poster child for not Sleeping.)  Mental health is a natural crossover into sleep tech and robots, with a $5,000 Japanese robot, Lovot, capable of responsive cuddling and comfort.

Best of the coverage:

  • CNET has probably the best coverage and articles on health which stick to the facts (slim in some cases as they are); anyone who wants to catch up with the feel and flavor of this three-ring circus can start and stay there. Their full show coverage is here.
  • Dr. Jayne at HISTalk also did an excellent health-related product roundup in her Curbside Consult column.
  • Mobihealthnews also has a very long running list of health tech pictures and announcements as part of its limited coverage, including the mea culpas and promised transparency of onetime health ed unicorn Outcome Health [TTA 29 Jan 18].

Beyond the plethora of products encouraging ever more to come forward, what ones will even make it to market, far more be winners? Aside from the Samsungs and P&Gs, which of these young companies planting their stake at CES will be there next year?  As in past CES, the wheel goes round and round, and where it stops, nobody knows–not even the JPM investors. 

Is Babylon Health the next Theranos? Or just being made out to be by the press? (Soapbox)

There, it’s said. A recent investigative article by a Forbes staff writer, European-based Parmy Olson (as opposed to their innumerable guest writers), that dropped a week before Christmas Eve raised some uncomfortable questions about Babylon Health, certainly the star health tech company on the UK scene. These uncomfortable bits are not unknown to our Readers from these pages and for those in the UK independently following the company in their engagement with the NHS.

Most of the skepticism is around their chatbot symptom checker, which has been improved over time and tested, but even the testing has been doubted. The Royal College of Physicians, Stanford University and Yale New Haven Health subjected Babylon and seven primary care physicians to 100 independently-devised symptom sets in the MRCGP, with Babylon achieving a much-publicized 80 test score. A letter published in the Lancet (correspondence) questioned the study’s methodology and the results: the data was entered by doctors, not by the typical user of Babylon Health; there was no statistical significance testing and the letter claims that the poor performance of one doctor in the sample skewed results in Babylon’s favor.  [TTA 8 Nov]. 

The real questions raised by the Lancet correspondence and the article are around establishing standards, testing the app around existing standards, and accurate follow up–in other words, if Babylon were a drug or a medical device, close to a clinical trial:

  • Real-world evaluation is not being done, following a gradual escalation of steps testing usability, effectiveness, and safety.
  • How does the checker balance the probability of a disease with the risk of missing a critical diagnosis?
  • How do users interact with these symptom checkers? What do they do afterwards? What are the outcomes?

Former Babylon staffers, according to the Forbes article, claim there is no follow up. The article also states that “Babylon says its GP at Hand app sends a message to its users 24 hours after they engage with its chatbot. The notification asks about further symptoms, according to one user.” Where is the research on that followup?

Rectifying this is where Babylon gets sketchy and less than transparent. None of their testing or results have been published in peer-reviewed journals. Moreover, they are not helped by, in this Editor’s view, their chief medical officer stating that they will publish in journals when “when Babylon produces medical research.” This is a sad statement, given the crying need for triaging symptoms within the UK medical system to lessen wait times at GPs and hospitals. But even then, Babylon is referring patients to the ED 30 percent of the time, compared to NHS’ 111 line at 20 percent. Is no one there or at the NHS curious about the difference?

And the chatbot is evidently still missing things. (more…)

Just the Fax. Or Matt Hancock versus the Fax Machines (UK) (Updated)

Updated. Add fax machines to the Endangered Device list. The news that Health Secretary Matt Hancock has banned the NHS from purchasing new fax machines starting in January 2019, with a full phaseout of use by 31 March 2020, was this past weekend’s Big News in the UK health sector. This is to help force adoption of paperless methods such as apps and email, which is a noble intention indeed.

The remaining prevalence of fax machines in the NHS became a cause célèbre after the Royal College of Surgeons in July estimated that over 8,000 fax machines were still in use. The RCS takes credit for nudging trusts to ‘Ax The Fax’. Guardian

This Editor presumes that Secretary Hancock does not possess a printer, or find the need to print his records even for convenience–or posterity. (One wonders what he’s carrying in that folder or brief…) I also presume that he has never heard of electrical outages, data breaches, malware or ransomware which may make print records suddenly quite needed.

The Road to Perdition is Paved With Good Intentions. A wonderfully tart take on Mr. Hancock’s Fax Obsession is contained in Monday’s NHSManagers.net newsletter from Roy Lilley. He looks at why NHS offices and practices have stayed with fax machines–and the absurdity of such a ban when trusts and practices are attempting to squeeze every penny in a cash-strapped, failing environment:

  • It’s point to point and legally binding not only in medicine, but in law and finance–even in the US
  • They are on the desk, easy to use–requiring only plug in to power and a phone line, fax toner, and paper
  • They don’t need IT support
  • Compared to computers, printers, and internet service, they are wonderfully cheap

And paper-free isn’t a reality even in the US with EHR, tablets and smartphones widely used. Even HHS and CMS in the US require some paper records. Confidentiality and hacking–especially when tied to computer networks–are problems with fax, but the same can be said for computer networksOh, and if your systems are attacked by ransomware, it’s awfully handy to refer back to printed records and to be able to communicate outside of computer networks.

Mr. Lilley also points out that ‘No 18’, as he dubs the Secretary of State for Health, actually has no power to enforce his edict with trusts or GPs.

This Editor predicts a thriving market in used and bootleg fax machines–“check it out”, as the street hustlers say!

Other articles on this: Fortune, Forbes

It’s Alive! BlackBerry still Sparking with an ‘ultra-secure hyperconnectivity’ healthcare platform

And this Editor thought that BlackBerry had long since hung up the ‘Out Of Business Sign’. In this era of BYOD in healthcare and software systems like Blue Cedar that secure apps from these BYODs from the device past the server, the image of the ‘Crackberry’ persists–tiny keyboard, tiny screen, and the corporate governed phone. All these loathsome features have now transitioned to iPhone 6s (tiny keyboard, tiny screen, corporate apps, locked down and trackable everything). (So much for that ‘tech will set you free’ world promised by Steve Jobs in the ‘1984’ spot, replaced by Big Brother–Ed. Donna)

BlackBerry, as a company based in Ontario, Canada, endures as a software platform minus the devices. Much like Nokia, they have taken on the world of IoT in areas demanding tight security. Their latest introduction is the BlackBerry Spark, a software platform they claim will lead the Enterprise of Things (EoT) to “ultra-secure hyperconnectivity from the kernel to the edge”. Hyperconnectivity, in their definition, will enable secure IoT equipment with consumer friendly interfaces, leverage AI and manage smart ‘things’ regardless of operating system and existing platforms, and making military-grade security easy and intuitive for users. Spark will be available to companies (thus EoT) by the end of 2018.

BlackBerry has evidently latched on to a messy need–the lamentable lack of security in most consumer IoT devices. They have also identified the yawning gaps in security in almost every healthcare enterprise in connected devices. In Mobihealthnews, their spokespeople expanded on the technology as they are applying it to healthcare via a quantum-resistant code signing server, a new system using blockchain to deliver medical data and an operating system for secure medical devices. More details on how these are being used so far were cited in their most recent release:

  • A blockchain digital ledger for the Global Commission, an organization focused on diagnostics for children with a rare disease. One of the pilots concentrates on BlackBerry’s powering real-time, actionable analysis to shorten time to diagnosis.  
  • A new OS for medical, QNX OS for Medical 2.0. This is described as a real-time operating system for the development of robotic surgical instruments, patient monitoring systems, infusion pumps, blood analysis systems, and other safety-critical products that must pass stringent regulatory approvals.
  • With the Mackenzie Innovation Institute (Mi2), participating in research around comprehensive security, patient privacy and intelligent connectivity in healthcare IoT.
  • Skin cancer research in Australia with the Melanoma Institute Australia.

Certainly BlackBerry is aiming for a certain sweet spot in healthcare and finding some partners all over the world, though the US seems to be absent. Will they be able to ‘crack’ it and the rest of the world? Time will tell.

The Theranos Story, ch. 57: was it Silicon Valley and Startup Culture bad practices pushed to the max?

[grow_thumb image=”http://telecareaware.com/wp-content/uploads/2018/07/Rock-1-crop-2.jpg” thumb_width=”125″ /]Theranos is now formally in California insolvency proceedings (note on their website). Creditors may have enough awarded to them to go down to the local pizzeria to buy a slice or two. Hard lessons indeed for creditors and shareholders. But aside from the drama yet to come in the trial of Elizabeth Holmes and Sunny now Shady Balwani, a/k/a the Silicon Valley Trial of the Century, are there any further lessons to be learned?

For those of us who have not been closely following The Theranos Story, David Shaywitz’s kind-of-review of John Carreyrou’s Bad Blood coupled with a thought piece in Forbes is especially appealing. Even if you’ve been tracking it closely like your Editor, it’s a good read. He posits that in three key areas, Theranos exhibited Startup Culture and Silicon Valley Ethics (or lack thereof) at the very extreme in these areas:

  • Secrecy: extreme compartmentalization, siloing, stratification, and rigid definition of roles that prevent information sharing. No outsiders in, or peer-reviewed research out.
  • Promises, promises, promises: a rosy picture to the point of delusion that masks real flaws
  • I Want To Believe: for various personal reasons, investors, press, and supports need to believe

Secrecy can and should work for companies in keeping proprietary information and competitive advantage intact. All startup and early-stage companies have to paint a positive picture in the midst of pitched struggle. The glass is always half full not empty even when the bank account is, but when the old ‘fake it till you make it’ becomes too strong, papering over the truth is the thing and the institutional absence of tough self-scrutiny (or a professional kicker-of-holes) prevents companies from fixing obvious problems–you get a delusional organization like Theranos edging gradually, then very quickly, into outright fraud. Finally, Theranos’ supporters had their own reasons for wanting to believe the technology worked. 

He goes on to state that the fraud that Theranos perpetrated was not only financial and in harm to health, but also in the hope that change is possible in healthcare delivery, we can challenge the way it’s always been done and win, and that technology can be empowering.

Will we, as a result, in Mr. Shaywitz’s words, take the ‘hit to hope’ to heart and become ‘excessively chastened and overcautious”? This Editor tends to be on the overcautious side when it comes to technologies such as IoT and AI because the potential for hacking and bad use is proven despite the hype, but far less so in challenging incumbents–even it it resembles tilting at windmills till they buy you.   

Will l’affaire Theranos change the Silicon Valley and Startup Culture for the better? Here is my ‘hit to hope’–that this excessively aggressive, conformist, borderline irresponsible, and secretive culture could change. This Editor doubts it’s even entered their leaders’ ‘deep’ thoughts, despite this best-selling book.

A more typical review of ‘Bad Blood’ is by Eric Topol, MD (!) in Nature–who certainly borrowed ‘The Theranos Story’ from this series of articles!