‘Silicon Valley Tech Press’ blamed in the Theranos buildup; WSJ threatened

[grow_thumb image=”http://telecareaware.com/wp-content/uploads/2016/04/Yak_52__G-CBSS_FLAT_SPIN.jpg” thumb_width=”150″ /]A fascinating view from an ironic source. Vanity Fair’s short article tags the buildup of Theranos and its founder/CEO Elizabeth Holmes to a purposefully gullible Silicon Valley Tech Press and their moneymaking conferences. While not naming specific publications, it cites TechCrunch’s Disrupt as an early builder-upper of Ms Holmes (drawing blood onstage, how daring!). The operating thesis here is that the tech press vetted her with uncritical and fawning coverage, which led to profiles and shiny articles in the New York Times, the New Yorker and ….Vanity Fair, which also featured Ms Holmes at their 2015 New Establishment Summit. It’s a classic PR strategy to me, one that any skilled marketer has in their playbook (Ed.–it also works in reverse, having mainstream press vet a technology sold B2B), and one that evidently worked.

One would think that writers and editors with some biotech and science knowledge would raise more questions. The author, Nick Bilton, critically outlines the ‘Game of Access’ underpinning the tech press and blogger business model: you say nice things and play ball, you get a preview of the latest gadget or a sitdown with the CEO. If you don’t, you’re shut out. So writers don’t ask tough questions, probe hard enough, or tell the truth about where the facts are leading them, because if they do, there goes the access and the sponsorships, as well as your job. While the former doesn’t apply to your Editors, many of us who write also hope that we uncover a technology that benefits people, or is even revolutionary. We like a bracing story.

However, Mr Bilton, perhaps mindful of the cart he rode in on, doesn’t scoop an equal share of blame onto the ‘mainstream’ press. To this Editor’s mind, the Ken Auletta profile in the New Yorker should have been stopped by the New Yorker’s EIC and sent back to Mr Auletta with a blue-penciled “DIG DEEPER”. This excerpt is from the VF article:

Auletta acerbically noted that the technology behind Theranos was “treated as a state secret, and Holmes’s description of the process was comically vague.” She told him, for instance, that one process occurred when “a chemistry is performed so that a chemical reaction occurs and generates a signal from the chemical interaction with the sample, which is translated into a result, which is then reviewed by certified laboratory personnel.”

Say wot? Sheer gobbledygook. For the WSJ investigative reporter John Carreyrou, who read this and eventually blew the lid off Theranos, this was caviar on toast too delicious to pass up. (Vanity Fair, on the other hand, was too busy making Ms Holmes one of its New Establishment, but investigative reporting has never been one of their strong points. Another reason why this article is an interesting read.)

A side note: Ms Holmes kept on refusing to disclose, even to VCs, the blood analysis process as a technology too secret to share, even with fellow researchers to get verification and validation. And that led to very few truly major VCs investing in the formerly $9 bn valued company, a point Mr Bilton relishes.

The final revelations in the article–truly the lead–should scare anyone who values a free press. They are the bullying tactics taken by Theranos’ legal team led by that new governing board member, David Boies, to intimidate both Mr Carreyrou and the WSJ from their investigative reporting. Mr Bilton’s source describes the team marching into the WSJ office in June, threatening legal action on the proprietary information Mr Carreyrou supposedly had (he did have internal documents). After repeatedly denying all requests for an interview with Ms Holmes, the WSJ went with the story in October, and the rest is history. Mr Boies now has his hands full elsewhere with other types of letters: CMS, SEC, DOJ and FDA. And Ms Holmes is no longer making herself available to the media, even to her former friends in the tech press. The Secret Culprit in the Theranos Mess

Theranos–the drama and examination continues

The latest chapters:

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

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

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

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

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

Theranos’ triple whammy: CMS, DOJ and SEC

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

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

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

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

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

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

Unspinning the Theranos scientific advisory board communications spin

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

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

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

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

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

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

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

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

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

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

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

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

‘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

 

A deserved goring of whiz-bang unicorns Theranos and Zenefits (updated)

[grow_thumb image=”http://telecareaware.com/wp-content/uploads/2015/08/1107_unicorn_head_mask_inuse.jpg” thumb_width=”150″ /]A blog posting this Editor wish she had written. Fred Goldstein, who is a consultant to healthcare systems focused on building accountability and improving population health, has pressed a sharp point to the sparkly bubbles surrounding two Silicon Valley billion-dollar valuation darlings, Theranos and Zenefits, on their playing fast and loose with basic regulations.

Some background for our readers. It’s a pile-on with Theranos, which has been stepped on by FDA for their nanotainers [TTA 20 Nov 15], then whacked by the Centers for Medicare and Medicaid Services (CMS) last month for ‘deficient practices’ at their California testing lab (a remedial plan has been filed this week) and likely losing its lucrative Walgreens Boots deal if problems aren’t fixed in 30 days (having already lost its program with Capital Blue Cross in the Harrisburg area of Pennsylvania). According to Bloomberg, its proprietary testing is now used in only 1 of every 200 tests. Zenefits claims to be the ‘first modern benefits broker’ with cloud-based software designed to simplify and automate such HR tasks as health insurance signups for small businesses, but its software that facilitated skating around required licensure requirements by its staff got its CEO forced out by a key investor, Andreessen Horowitz. (And it gets worse…read on….)

It’s so…whiz-bang! (Updated) Your Editors, past and present, have made hash (corned beef and otherwise) of companies promising revolutions in healthcare since our inception. ‘Whiz bang’ (more…)

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.

Silicon Valley’s betting on ‘citizen doctors’, ‘citizen science’ and useful data

A fascinating and slightly cynical overview of Silicon Valley’s ideological view of health tech that will fix our ‘deeply flawed healthcare system’ and what is getting funded (or not) is in next month’s San Francisco magazine. It profiles the ‘citizen doctor’ founders of vital signs ‘tricorder’ Scanadu (Sam–who’s not often mentioned–and Walter De Brouwer), bacteria tracker uBiome, ‘personal data recorder’ and experience charter We Are Curious (founded by Linda Avey, a long-departed co-founder of 23andme) and touches on the Theranos debacle. While these stories are bracing and in the instance of the De Brouwers, courageous, the notion of ‘citizen science’ (defined as direct-to-consumer health data) and its companion, Dr Eric Topol’s patient-centered/controlled medicine, has its drawbacks, viewed through the slightly gimlety ‘digital doctor’ eye of UC San Francisco’s Dr Robert Wachter. “The overarching message—not just from Theranos but from other companies struggling to get a toehold—is that, ultimately, the laws of economic gravity hold. The companies will have to produce products that add real value, either to patients or to payers. If they don’t, the market—or the regulators—won’t treat them kindly.” Flatly, there aren’t enough Quantified Selfers right now to support these companies. And Mr Market is a hard master. 23andme is back in the good graces of the FDA after a two-year scuffle and back doing direct response TV here in the US. Scanadu’s two products, Vitals (formerly Scout) and Urine are still not through the long slog of FDA clearance. The jury’s out on Theranos. And all these companies, including ‘unicorn’ Theranos, are bleeding cash and nowhere near turning a profit. ModernLuxury. Hat tip to Dr Topol via Twitter, who had a patient-centered conversation with Dr Wachter that we covered back in September.  Another recent podcast with Dr Wachter is here (Community Health Center radio).

Update: ‘Citizen science’ is nothing new, as revealed by the Science Museum (London)–it’s over 300 years old. While it entered the OED in 2014, ‘in 1715, Edmund Halley used Philosophical Transactions to ask colleagues to help him observe a total solar eclipse, prompting observers from all over the country to respond.’ Other examples are from Benjamin Robins in the same publication in 1749 on fireworks, Charles Darwin and evolution, to the present day. The difference is the flow–similar to what we now call crowdsourcing versus the individual using the data to affect their care.

 

Is Theranos’ ‘blood testing for all’ a responsible selling proposition?

Theranos’ recent troubles on their blood testing (Walgreens halting expansion, FDA halting nanotainers as ‘uncleared medical devices’ and last week chain grocery/drugstore Safeway dropping their $350 million deal for 800 locations) have been well covered in media both here and elsewhere. But what if their Unique Selling Proposition–that people should have the ‘basic human right’ to order up their own inexpensive blood tests and then be responsible for their own interpretation–is counter-productive for many patients? After all, it’s what Theranos has been organized and raised $400 million+ on. Dr Robert Wachter of UCSF, who is no top-down Ezekiel-esque ‘nanny stater’, lends a caution: “There are a lot of companies, including Theranos, that have an interest in making you believe that more data will magically make you healthier. It won’t, at least not in the short-term.” When is ’empowerment’ confusing without recourse to interpretation? Some results are easier to read than others. Does having the data make the average person healthier for real? Personally, this Editor would welcome the ability to walk into her local Walgreens and order up a few to see what’s up–but then again she can do her own research and ask a doctor or nurse to help. Who can (inexpensively) close the interpretation gap? Theranos is wrapped in scandal but goes hard to change laws to its advantage (Mashable)

Theranos/FDA update: nanotainers are ‘uncleared medical devices’

And the battering of their USP continues. On the heels of Walgreens Boots Alliance (which this week proposed a merger with #3 Rite Aid to create the largest by location US drugstore chain) putting a screeching halt on expanding its 41 Theranos testing locations, the FDA has told Theranos that its nanotainers are actually ‘uncleared medical devices’ which further violate because they are being shipped over state lines. The company was also scored on handling complaints poorly, keeping poor records and failing to conduct quality audits including on the manufacture of the nanotainers. These were revealed on redacted FDA Form 483s filed as a result of a month-long inspection ending in mid-September, which were published per a Freedom of Information Act (FOIA) request. According to MedCityNews, the nanotainers were mistakenly classified as Class I and not II. Fortune quotes one of the reports: “The design was not validated under actual or simulated use conditions,” (more…)

Blood is drawn: Theranos responds vigorously to TTA re WSJ

From his very first interactions with Theranos, the reporter made abundantly clear that he considered Theranos to be a target to be taken down, and not simply the subject of an objective news story. The articles that appeared last week are the inevitable product of that approach.–Theranos Facts, 22 Oct

Breaking news. Blood is drawn. A spokesperson for Theranos (from FTI Consulting), Ms Shea Maney, has responded directly to this Editor regarding the content of the Wall Street Journal article, previously covered here (The $9 billion question mark) along with followup in primarily Fortune but also commentary in the Health Care Blog. Her note to me (which undoubtedly has gone to other press) is reprinted below in its entirety, save the standard closing line:

We read your coverage of Theranos with interest, and noticed you were particularly interested in accuracy and our finger-stick tests, among other themes. There have been a lot of inaccuracies in the coverage of these topics, which is why we have posted detailed information on our technology, accuracy, and conversations with The Wall Street Journal on our website: https://www.theranos.com/news/posts/custom/theranos-facts

On accuracy: Theranos’ technology is reviewed by regulators, proven in the field, and praised by leaders in the industry and doctors and individuals that we serve. We are confident in the reliability of our tests, because we have validated their accuracy. (more…)

The Theranos Kerfuffle: a setback, but is it for the best? (updated)

[grow_thumb image=”http://telecareaware.com/wp-content/uploads/2015/10/question_mark.jpg” thumb_width=”120″ /]Some clarity emerges from the controversy around Theranos and last week’s Wall Street Journal exposé [TTA 16 Oct]. Last week’s rebuttal/denial released by the company said remarkably little, which disturbed Roger Parloff, the Fortune writer who profiled the company in June 2014’s high-profile cover story. He failed to reach CEO Elizabeth Holmes, who on her break from an all-day with the Harvard Medical School Board of Fellows, taped a segment with CNBC stock tout Jim Cramer (a questionable priority indeed–Ed.) Fortunately he received more specific answers via email from General Counsel Heather King. It clarifies among other things that venipuncture, not finger stick, is used in the majority of their tests in practice, and that dilution of samples is within industry practice for use in third-party analyzing machines. There also seem to be two sides to the proficiency-testing story. (Oddly, no mention of the sensational claims around British biochemist Ian Gibbons who was key to Theranos’ patent development and the alleged legal threats to his widow.)

For those who have difficulty getting through the WSJ paywall, Mr Parloff’s summary of the WSJ article’s main points is helpful. His conclusion: Theranos is wisely ‘dialing back’ its USP on drawing blood through finger stick to “Smaller samples. Smaller needles. Better experience.” (A neat pivot from what Theranos ‘made their bones’ on and still features–tiny finger-sticks.) His open-ended question (for, presumably, the next article): can it profitably run its low-cost testing business when it’s using the same analyzing machines as the big testing labs; and while cheaper, can doctors and patients trust the Theranos tests (which are a matter of health, and perhaps life and death) if they’ve flunked their first test at transparency?

Another view from Health 2.0 supremo Matthew Holt over at his Health Care Blog is that for Theranos, this blow is eminently recoverable if they play their cards right. Witness the recovery made by 23andMe, now in the good graces of FDA after having blown it badly to near-shutdown. (more…)

Is Theranos a $9 billion question mark?

Breaking News. According to an exposé published yesterday in The Wall Street Journal*, low-cost and fast growing small sample blood testing company Theranos [TTA 28 Aug] is not ‘doing what it says it does’. Four former employees allege that Theranos’ testing system, dubbed the Edison, which processes small finger-pricked blood samples collected in ‘nanotainers’, only handles a fraction of the tests claimed–19 out of 205. In a complaint to regulators, one Theranos employee accused the company of failing to report test results that raised questions about the precision of their proprietary Edison system–and that most of the tests were being run on traditional testing machines which required dilution of the tiny samples. The article reports on serious questions which have been raised on the accuracy of the Edison testing versus conventional testing, including the integrity of finger-pricked blood and sample dilution. Gaps in results were seen last year on tests for vitamin D, two thyroid hormones and prostate cancer, though Theranos has been reporting its tests to CMS in a process that all labs go through called proficiency testing, and has one test for herpes that has been FDA cleared.

In a follow up article, Theranos reportedly is no longer collecting nanotainers except for the FDA cleared herpes test.

Theranos is currently valued at $9 billion and has raised over $400 million in VC funding.

According to the first article, British biochemist Ian Gibbons, (more…)

Integrating inexpensive lab testing, imaging to EHR–and vice versa

In the Dr Eric Topol patient-driven world, personal lab testing would be walk in, keep retail hours and not even need a doctor’s order. That is the model for Theranos, a well-funded low cost blood testing company operating 43 centers in California, Arizona (no doctor order needed) and one Pennsylvania Walgreens. Their latest alliance is with EHR physician practice giant Practice Fusion, which claims about 112,000 doctors actively using its cloud-based, ad supported platform, claims to be the fastest growing US EHR with at present 100 million patient records. The Theranos reporting app, which also connects patients with doctors who can help interpret the results (MD Connect) integrates with other EHRs (though not listed) and now the results will also show in their Practice Fusion patient record. Practice Fusion is also integrating imaging center RadNet‘s results.

Since the late 2000s, Practice Fusion has historically been the game changer in cost (one of the first in the cloud) and in catering to smaller practices. They are good at managing their hype, but as Neil Versel points out, there’s been a CEO ‘change-lobsters-and-dance’, there are questions about revenue and their awaited IPO seems far away, especially given the recent market upset. Hospital EHRs Cerner, Epic and NextGen now all have lower-cost practice versions that integrate with hospital versions. An American College of Physicians (ACP) 2014 survey identified that Practice Fusion is third (and tied with others) among most used practice EHRs behind Epic and eClinical Works, though strongest in solo practices. On the polar opposite of Mr Versel’s skeptical article is this breathless Forbes piece which confuses partnerships with acquisitions. Perhaps self-made billionaire Theranos CEO Elizabeth Holmes may decide to buy Practice Fusion!

Apps and wearables – developments over the summer

Trying at least temporarily to distract this editor’s attention from his recent unfortunate experience with Jawbone technology, here are some interesting app and wearables snippets received over the summer.

We begin with news of the first CE certified mole checking app, SkinVision which rates moles using a simple traffic light system (using a red, orange or green risk rating). The app lets users store photos in multiple folders so they can track different moles over time. It aims to detect changing moles (color, size, symmetry etc.) that are a clear sign that something is wrong and that the person should visit a doctor immediately.

This contrasts with the findings of a paper published in June examining 46 insulin calculator apps, 45 of which were found to contain material problems, resulting in the conclusion that :”The majority of insulin dose calculator apps provide no protection against, and may actively contribute to, incorrect or inappropriate dose recommendations that put current users at risk of both catastrophic overdose and more subtle harms resulting from suboptimal glucose control.”, which to say the least of matters is worrying. (more…)