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 not a bubble, really! Or developing? Analysis of Rock Health’s verdict on 2018’s digital health funding.

The doors were blown off funding last quarter, so whither the year? Our first take 10 January on Rock Health’s 2018 report was that digital health was a cheery, seltzery fizzy, not bubbly as in economic bubbles.  Total funding came in at $8.1 billion–a full $2.3 bn or 42 percent–over 2017’s $5.7 bn, as projected in Q3 [TTA 11 Oct]–which indicates confidence and movement in the right direction.

What’s of concern? A continued concentration in funding–and lack of exiting.

  • From Q3, the full year total added $1.3 bn ($6.8 bn YTD Q3, full year $8.1 bn) 
  • The deals continue to be bigger and fewer–368 versus 359 for 2017, barely a rounding error
  • Seed funding declined; A, B, C rounds grew healthily–and D+ ballooned to $59M from $28M in 2017, nearly twice as much as C rounds
  • Length of time between funding rounds is declining at all levels

Exits continue to be anemic, with no IPOs (none since 2016!) and only 110 acquisitions by Rock Health’s count. (Rock only counts US only deals over $2 million, so this does not reflect a global picture.)

It’s not a bubble. Really! Or is it a developing one? Most of the article delivers on conclusions why Rock Health and its advisors do not believe there is a bubble in funding by examining six key attributes of bubbles. Yet even on their Bubble Meter, three out of the six are rated ‘Moderately Bubbly’–#2, #3, and #5–my brief comments follow. 

  1. Hype supersedes business fundamentals (well, we passed this fun cocktail party chatter point about 2013)
  2. High cash burn rates (not out of line for early stage companies)
  3. Unclear exit pathways (no IPOs since ’16 which bring market scrutiny into play. Oddly, Best Buy‘s August acquisition of GreatCall, and the latter’s earlier acquisitions of Lively and Healthsense didn’t rate a mention)
  4. Surge of cash from new investors (rising valuations per #5–and a more prosperous environment for investments of all types)
  5. High valuations decoupled from fundamentals (Rock Health didn’t consider Verily’s billion, which was after all in January)
  6. Fraud or misuse of funds (Theranos, Outcome dismissed by Rock as ‘outliers’, but no mention of Zenefits or HealthTap)

Having observed bubbles since 1980 in three industries– post-deregulation airlines in the 1980s, internet (dot.com) in the 1990s, and healthcare today (Theranos/Outcome), ‘moderately’ doesn’t diminish–it builds to a peak, then bursts. Dot.com’s bursting bubble led to a recession, hand in hand with an event called 9/11.

This Editor is most concerned with the #5 rating as it represents the largest divergence from reality and is the least fixable. While Verily has basically functioned as a ‘skunk works’ (or shell game–see here) for other areas of Google like Google Health, it hardly justifies a billion-dollar investment on that basis alone. $2 bn unicorn Zocdoc reportedly lives on boiler-room style sales to doctors with high churn, still has not fulfilled its long-promised international expansion, and has ceased its endless promises of transforming healthcare. Peleton is a health tech company that plumps out Rock Health’s expansive view of Health Tech Reality–it’s a tricked out internet connected fitness device. (One may as well include every fitness watch made.)

What is the largest divergence from reality? The longer term faltering of health tech/telecare/telehealth companies with real books of business. Two failures readily come to mind: Viterion (founded in 2003–disclosure, a former employer of this Editor) and 3rings (2015). Healthsense (2001) and Lively were bought by GreatCall for their IP, though Healthsense had a LTC business. Withings was bought back by the founder after Nokia failed to make a go of it. Canary Care was sold out of administration and reorganized. Even with larger companies, the well-publicized financial and management problems of publicly traded, highly valued, and dominant US telemed company Teladoc (since 2015 losing $239 million) and worldwide, Tunstall Healthcare’s doldrums (and lack of sale by Charterhouse) feed into this. 

All too many companies apparently cannot get funding or the fresh business guidance to develop. It is rare to see an RPM survivor of the early ’00s like GrandCare (2005). There are other long-term companies reportedly on the verge–names which this Editor cannot mention.

The reasons why are many. Some have lurched back and forth from the abyss or have made strategic errors a/k/a bad bets. Others like 3rings fall into the ‘running out of road and time’ category in a constrained NHS healthcare system. Beyond the Rock Health list and the eternal optimism of new companies, business duration correlates negatively with success. Perhaps it is that healthcare technology acceptance and profitability largely rests on stony, arid ground, no matter what side of the Atlantic. All that money moves on to the next shiny object.(Babylon Health?) There are of course some exceptions like Legrand which has bought several strong UK companies such as Tynetec (a long-time TTA supporter) and Jontek.

Debate welcomed in Comments.

Related: Becker’s Hospital Review has a list of seven highly valued early stage companies that failed in 2018–including the Theranos fraud. Bubble photo by Marc Sendra martorell on Unsplash

Is the clock at the funding pub pointing to ‘last call’? (Updated)

[grow_thumb image=”http://telecareaware.com/wp-content/uploads/2012/12/crystal-ball.jpg” thumb_width=”150″ /]And we were having such a good time! UPDATED Having ridden a few hype curves (in health tech and out–remember airline deregulation?) and with the bruises to prove it, this Editor believes that she can spot a Cracking Market at forty paces. The hands on the clock appear to be near closing time, even as we party on. After all, DTC telehealth is forecast to be $25 bn in the US by 2025 (GrandView Research), if we make it that far!

Where are the sharp noises coming from?

  • The continuing fail of unicorns like Theranos [TTA 4 May and prior], now resorting to bullying the Wall Street Journal and negotiating with the alphabet (SEC, DOJ, FDA, CMS…), and the troubles of Zenefits. 
  • Another notable unicorn, the doctor booking site ZocDoc, being called out at last on their customer churn, low margins, and high customer acquisition costs. (As well as an irritant to doctors and office managers) New York Business Journal
  • Extremely high and perhaps insane rounds of funding to young companies with a lot of competition or a questionable niche. Higi is an odd little kiosk + consumer engagement program located in primarily Rite Aid drugstores–odd enough to score $40 million in its first venture round. (Ed. note: I shop at Rite Aid–and have never seen one.)This is after the failure of HealthSpot Station, which burned through approximately $43 million through its entire short but showy life. The low-cost, largely exchange plan insurer Oscar Health raised $400 million this February  ($727 million total) while UnitedHealth and others are dropping money-losing plans in most states. Over 50 percent of exchange co-ops went out of business in 2015, leaving doctors, health systems and patients holding their baggage. Again, low margins, high cost and high customer acquisition costs.
  • We’ve previously noted that funders are seeking ‘validation in similarity’–that a few targeted niches are piling up funding, such as doctor appointment setting, sleep trackers and wellness engagement [TTA 30 Dec 15]
  • Tunstall’s continuing difficulty in a sale or additional financing, which influence the UK and EU markets.
  • NEW More patent fights with the aim of draining or knocking out competition. We’re presently seeing it with American Well litigating Teladoc over patent infringement starting last year, which is only now (March) reaching court. It didn’t stop Teladoc’s IPO, but it publicly revealed the cost: $5 million in previously unplanned lobbying and legal costs, which include their fight with the Texas Medical Board on practicing telemedicine–which is beneficial for the entire industry. (But I would not want to be the one in the legal department explaining this budget line.) Politico, scroll down. But these lawsuits have unintended consequences–just ask the no-longer-extant Bosch Healthcare about the price of losing one. (more…)

‘VC tourism’ in Health Tech Land is over (updated)

The ‘silly money’ is packing its bags and taking the next flight from the Coast. An exceedingly tart take out of Fast Company confirms what your Editors have noticed in Rock Health and other year-end reports. Funding for digital health may have surpassed $4.2 billion in 2015, but it barely eked over 2014’s total of $2.3 billion despite rising geometrically since 2011 [TTA 16 Dec 15, revised by Rock Health since then]. Since then, we’ve had the Trouble Every Day of ‘unicorns’ (overreaching) Theranos and (ludicrously) Zenefits [TTA 17 Feb]; EHR Practice Fusion stalled out and cutting 25 percent of its staff, hoping to be acquired by athenahealth–or anyone (Healthcare Dive); shaky Fitbit shares [TTA 20 Feb]. Perhaps the high point was last year’s ‘Corvette Summer’ with yet another big round to a company yet to fulfill its promise, ZocDoc [TTA 15 Aug 15]. Even Castlight Health with decent revenue (still at a loss) has been dubbed an ‘absolute horror show’ when it comes to its share prices, if you were foolish enough to buy it at or near its IPO.

Fortunately a large dose of sanity may prevail among VCs with a sobering realization–no different than five or ten years ago–that investment has to be strategic and far longer than the usual 18 month-and-out time frame. Too many companies have systems which work the same niche–you don’t need 50 companies doing these things: data analytics for care management, patient engagement platforms, med reminders or diabetes management. [We’ve already noted the ‘sameness’ in companies getting funded in 2015, almost as if investors were seeking reassurance in similarity, a sure sign of a coming fail–TTA 30 Dec 15.]

Developers must fill a need–uniquely. And have a superb business plan, squeeze the nickels till they squeak and forget about the party culture. Investors: Dumb Money For Digital Health Will Vanish As Quickly As It Came In

 

Rounding up the funding rounds of 2015–and the deals some would like to see (?)

Mobihealthnews rounded up 2015’s hot funding in the mobile health/health tech-related space, with helpful links to their articles. They cite as we have previously [TTA 16 Dec] Rock Health‘s flattish year-to-year 2015 total of $4.3 bn, but also StartUp Health’s bloom-off-rose 2015 digital health total of $5.8 bn–larger than Rock Health’s tote, but 17 percent off their 2014 total of $7 bn. If you consider the proportions: the top 10 deals raised $738 million–$130 million alone to the endlessly funded but yet to take over the world ZocDoc –the roster below $20m remains the longest, which is completely in accord with the lower part of Rock Health’s pyramid of angel-A-B rounds.

Yet Aditi Pai’s detailed summary strikes this Editor as useful in an unanticipated way. There is a certain sameness in the products and services of these companies, as if funders are seeking validation in similarity. ZocDoc, DoctoLib and Vitals–doctor profiles and appointment booking. Sharecare, Welltok, Novu, Noom, AbilTo, SocialWellth, Health Recovery Solutions, Jiff–health and wellness engagement programs/apps, many for corporate programs. Whoop, Sano, Sproutling, TuringSensor, Valencell, Moff and four others–wearables. Hello, Sleepace, Sproutling (baby)–sleep tracking. Klara, SkinVision, Spruce–dermatology apps. Beyond the gloomy forecast for unicorns (Theranos being the Child on the Milk Carton), how many of these corporate wellness programs, sleep trackers and wearables will be around in 2017? Mobihealthnews’ 2015 funding roundup.

MedCityNews takes a lighter-hearted (I think) look at 2016 deals. IBM would buy athenahealth mainly for its EHR and practice management data, plus data aggregator Validic, to beef up Watson; 23andMe, past its two years of troubles after stepping on FDA Superman’s cape, would buy PatientsLikeMe (endangering its community shaped credibility? 23PatientsLikeMe?) and the best–Theranos bought by Boston Heart Diagnostics/Eurofin (EU lab testing giant), which would reduce this unicorn to a pony…but one that might make it. Theranos also made VentureBeat’s list of Likely Carcasses in the Valley of Unicorn Death (to quote the article’s author). Chris Seper’s Deals He’d Like To See.

Better’s fast fail, ending health assistance service 30 Oct

[grow_thumb image=”http://telecareaware.com/wp-content/uploads/2015/10/Better.png” thumb_width=”150″ /]Better is sadly not. This two-year old service that provided personal health assistance, including a real, live health assistant, to guide members through health questions, the thickets of insurance claims, finding doctors and specialists, apps and more, announced earlier this week that it was ending operations as of 30 October. While it was announced via their Twitter feed on Tuesday, most of the industry learned of it through Stephanie Baum’s article in MedCityNews today. Better formally debuted only 16 months ago [TTA 23 Apr 14] and at the time this Editor felt that it was a service in the right direction, a kind of ‘concierge medicine for the masses’ needed when individuals have to direct more and more of their own care.

A solid start, as our Readers have seen, does not guarantee success, but this fast fail is still fairly shocking. A concern at the time was the pricing for the full service model at $49/month, which later became the family price (individuals were $19.99/month). CEO/co-founder Geoff Clapp was among the most Grizzled of Health Tech Pioneers; he had been a co-founder of Health Hero/Health Buddy from 1998 to its sale to Bosch Healthcare, a very long pull in telehealth, and he had spent much of his post-Health Hero time generously advising other startups. Yet despite the involvement of blue chip Mayo Clinic as a service provider, its financial backing from their investment arm and socially-oriented VC Social+Capital Partnership, it managed to raise only its initial seed funding of $5 million (CrunchBase).

So what happened? (more…)

Unicorns to Series A–health tech funding gained in (perhaps) the nick of time

[grow_thumb image=”http://telecareaware.com/wp-content/uploads/2015/08/1107_unicorn_head_mask_inuse.jpg” thumb_width=”150″ /]Money, money everywhere–unicorns get the headlines, but the companies are still (largely) small

Up until early August, this Editor would have assumed that our Readers would look at this funding roundup as a bracing windup to a largely positive eight months and a veritable Corvette Summer for healthcare technology funding. We may have to give back the keys a little sooner than we imagined. Will the dropping market affect digital health as 2008-9 did–‘out of gas’ for years? Or will it barely affect our motoring onward? Despite the Dow Jones average hitting an 18 month low today, we hope it’s closer to the latter than the former. though the new and big entrant to digital health investing is the country most affected, China.

Our roundup of the August Action includes ZocDoc, Fitbit, Alphabet, PillPack, Owlet and more, along with a few comments:

**ZocDoc, a NYC-based online medical care appointment service that matches patients with doctors by location and schedule, had the most sensational round with last week’s Series D funding of $130 million, giving it a valuation of $1.8 bn. It took over a year after the filing (June 2014) and was led by two foreign funds (London-based Atomico and Edinburgh-based Baillie Gifford) with additional funding from Founders Fund, which previously participated in raises of $95 million.

Though it claims 60 percent coverage in the US  and ‘millions of users’ (numbers which have been quoted for some years), ZocDoc won’t disclose profitability nor volume–metrics that would be part of any IPO.

Direction? Points given for deciphering this windy statement (quoted from Mobihealthnews): (more…)

Rock Health’s mid-year report: 2015 investment leveling off

Rock Health‘s 2015 report is revealing in one aspect–that the authors try to put a game face on what is a flat situation in digital health investment for first half. Not even the most optimistic of the digerati expected a lift of 16 percent as we saw in 2014 versus 2013 [TTA 2 July 14], but the 8.7 percent fall off from 2014’s blistering $2.3 billion to $2.1 billion in 2015 year-to-date was unexpected. StartUp Health’s report indicated a slower start to 2015, though slightly less, so the reports correspond. Digital health still is growing faster than software, biotech and medical device.

Other highlights:

* The top six categories accounted for 50 percent of investment funding: wearables, analytics, consumer engagement, telemedicine, enterprise wellness, EHR/clinical workflow

*  In M&A action, this year’s first half has almost matched 2014’s full year total, but with only 13 percent of the investment. Most are digital health companies acquiring others for small amounts. (more…)

Two-thirds of US insured not interested in payer health apps: survey

A survey of over 1,200 insured (individual and employer plans) sponsored by research firm HealthMine and conducted by Survey Sampling International shows that only 30 percent of this group would participate in a payer-provided mobile app, despite 89 percent using a smartphone and/or tablet. Even worse, only 18 percent liked to learn health, wellness, and lifestyle information from a mobile app. It demonstrates that current apps are not compelling or engaging–and the huge paradox of payers make them less, not more, attractive. Perhaps this Editor goes out on a limb, but US insurers have a trust problem on multiple levels (as claim deniers, as impossible to deal with); apps they provide are perceived as capturing information an individual doesn’t really want them to see. Overall, users are not using their smartphones for health reference at all–well below 20 percent. The leading use is for tracking fitness (21 percent) and calorie counting (16 percent). Is it that real research on health is the province of the desktop PC, where it’s easier to find and read? They also aren’t using mobile to find their doctors, despite all the hype from ZocDoc and Vitals: 8 percent had used a doctor finder app in the past six months. Mobihealthnews, HealthITOutcomes

Ka-ching! Mid-year digital health funding hits $2.3 B: Rock Health

[grow_thumb image=”http://telecareaware.com/wp-content/uploads/2014/07/stick_figure_push_up_arrow_400_clr.png” thumb_width=”120″ /]It’s geometric! Rock Health’s total of $2.3 billion in digital health funding as of June 2014 just rocketed through the $1.97 billion 2013 full year total. Year over year to date, it’s up over 16 percent. And there’s stardust on every sub-sector: software, digital health, biotech and even medical device, the laggard (negative growth) in previous reports. Funding rounds must have taken vitamins, because they are 50 percent larger on average at $15 million versus last year’s $10 million. But there’s the same concentration on big deals like NantHealth, Flatiron Health, Alignment Healthcare and Proteus, heavily skewed towards payer administration, digital health devices, data analytics and healthcare consumer engagement. But the clouds on the horizon are there. Last year’s disproportion in seed/Series A accelerates, and the ‘down the line’ weakness continues with proportionally fewer companies reaching B, C and D rounds. Crowdfunding has also lost its luster–50 percent off with Indiegogo dominating–but its blowout with Healbe GoBe [TTA 26 June, CEWeek] accounted for 41 percent of total crowdfunding dollars; MedStartr stayed in the game at a distant second. IPOs haven’t been great, the ‘digital health index’ is an underperform yet funders are still itchy to cash out multi-round companies like Practice Fusion (EHR/billing), Proteus and ZocDoc via IPO. VentureBeat. Rock Health report on Slideshare.

Babylon app for booking GP visits debuts (UK)

Making news out of Tuesday’s Wired Health UK 2014 at the Royal College of General Practitioners (RCGP) in London is Babylon. From the app (iPhone, Android), appointments with a GP or specialist can be booked 12 hours a day, six days a week, with one of the almost 100 part time salaried and on call doctors in Babylon’s system or a BUPA (private healthcare/insurance system) physician. Also bookable through the app are diagnostic kits and blood tests;  X-rays or scans would be at a partner facility. Have a question or want to check your symptoms? The app directs your text and pictures to a doctor or nurse. Need a prescription? Delivered to your home or a nearby pharmacy. Record storage is on your phone. All for £7.99/month for basic service or £24 per consult–both low prices that seem to be introductory (a/k/a not profitable) or for light users. Babylon is registered with the Care Quality Commission, an independent healthcare regulator, and has designated body status from NHS London.

Founder Ali Parsa, a former Goldman Sachs banker who previously founded Circle, approvingly says that booking an appointment is as simple as ‘booking a Hailo cab’ (in NYC, Uber). This is a more complete model than a ZocDoc or Vitals (US appointment services) with testing and a symptom checker, but it does not seem to have a video consult (more…)

NaviGo Health: matching doctors and patients like a dating site

Here in NYC, the major success envy story for eHealthy entrepreneurs has been doctor appointment-setting website ZocDoc. With multiple rounds of funding from the likes of Goldman Sachs, it’s appeared to have unassailable ‘cred’ and ownership on a national basis. Cleveland Ohio-based NaviGo Health wants to cut a small and specialized slice of this pie through using a ‘dating model’ process. (This Editor wondered “why didn’t I think of that?”) Their platform CompassMD matches newly diagnosed cancer patients with doctors, based on how both parties answer a list of questions based on communication, decision-making, treatment and personality preferences. The founders are working out of co-working space at a Shaker Heights Ohio accelerator, LaunchHouse (built in a 1950s car dealership!), and on ‘FFF’ money attempting to snag a pilot. The website’s a home page, they tweet at @navigohealth. Can a few docs out there lend them a hand on their pilot? Maybe some crowdfunding and Health 2.0 folks to the rescue? Compatability (sic) matters: NaviGo Health puts an online dating-style twist on physician searching (MedCityNews)