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Thursday, October 29, 2015

"Interoperability? We don't need no steenkin' definition."

That's what I would say. But, consider this, from THCB:
Defining Interoperability: An Interview with Grahame Grieve
by Leonard Kish

Grahame Grieve is a long-time leader within HL7 and one of the key drivers behind FHIR. He chats with Leonard Kish about what’s been happening and what’s ahead for interoperability...

LK: There’s a lot of talk in congress about the lack of interoperability and everyone probably has their own definition. Do you have a working definition of interoperability or is there a good definition you like for interoperability?

G: The IEEE definition to get data from one place to another and use it correctly is pretty widely used.  I guess when you’re living and breathing interoperability you’re kind of beyond asking about definitions...

It’s actually relatively easy to move data around. What you’ve got to do is consider the costs of moving it, the fragility of the solution, and whether the solution meets the user’s needs around appropriateness, availability, security, and consent.  Given the complexity of healthcare and business policy, it’s pretty hard to get a handle on those things. One thing that is key is that interoperability of data is neither here nor there in the end because if providers continue with their current work practices, the availability of data is basically irrelevant, because they treat themselves as an island. They don’t know how depend on each other...

I think of standards as a precondition. If they can exchange data correctly then they can start asking themselves whether they want to.  Whereas if they can’t exchange data correctly and usefully then they don’t even get to ask the questions.  So standards is just a precondition to asking “How do we have patient focused care without having to build specific institutions around a particular process?”...

LK: Can you tell us a little bit about how SMART On FHIR enhances FHIR and are there going to be other things on FHIR as we go forward with different enabling bodies working together?

G: FHIR is a base API for all sorts of usages.  One of the most common usages is going to be exchanging healthcare information between EHR’s and within an EHR in its internal extensibility environment.  And that’s where SMART On FHIR fits in and provides a really neat solution for what EHR’s need to do.  So personally I think most data exchange using FHIR will use SMART on FHIR because the driving need is in the EHR space.  And I think Smart On FHIR is a great extension to FHIR around that. I think there’ll be other extensions that are more in the corporate backbone space and more knowledge-based service, things that are not so user specific. Those aren’t formed yet and SMART On FHIR is the one we’re throwing all our weight behind because it meets the immediate needs...
"when you’re living and breathing interoperability you’re kind of beyond asking about definitions."

I must have missed that day in science class. BTW: I've had my say about APIs, and HL7/FHIR, e.g., here, here, and here.

Let's recall the IEEE definition:
interoperability: Ability of a system or a product to work with other systems or products without special effort on the part of the customer. Interoperability is made possible by the implementation of standards.
"without special effort on the part of the customer."

It looks to me like we're going to "define interoperability down" by eliminating (at least implicitly) that clause of the IEEE definition.

Look at ONC's take:
Defining the Difference between Health Information Exchange and Interoperability
Because exchange is a prerequisite for interoperability, here at ONC we’ve focused a lot of attention on it...

But we must always remember that exchange is only part of the puzzle. If I send an email from one computer to another computer, I have exchanged information between those two systems. But if I write my message in French, (and you can only speak English), there is no way for you to automatically use the information that has been exchanged without risking losing something in translation...I may have exchanged information, but I won’t be able to seamlessly use the information in the new system to alert the provider automatically of a new drug allergy, for example. So to get to health information interoperability, we need more than just transport standards:  we must also use standards for vocabularies and terminologies (to help standardize the meaning of the words that we use), standards for structure (so computers know how to break a message into the appropriate information chunks), and potentially other kinds of standards...
I had run at the "French-to-English" thing back during November 2013 while covering the NYeC Conference in NYC.

I have some lingering Interop questions. One goes to the humorous phrase proffered by one of the presenters:

"Smiling Almighty Jesus."

The point was miscommunication resulting from information garble over time between people. The above refers to a dx of "Spinal meningitis," which the elderly fictional patient in the slide got wrong. As it goes to HIE, this aligns with my chronic rant about a data dictionary standard. As I have observed by way of analogy:
True interoperability requires a comprehensive data dictionary standard. Without it, information can become “garbled.” That is, altered during sequential transmissions. For example, what if you took these sentences and ran them through Google Translate from one language to another — say, [1] from English to Spanish, [2] then from Spanish to French, [3] then from French to German, [4] then from German to Greek, [5] then from Greek to Swedish, [6] then from Swedish to Portuguese, and [7] then back to English?
  1. Verdadero interoperabilidad requiere un amplio diccionario de datos estándar. Sin ella, la información puede llegar a ser "confusa". Esto es, alterado durante las transmisiones secuenciales. Por ejemplo, ¿qué pasa si usted tomó estas frases y las pasó por Google traducir de un idioma a otro - por ejemplo, del Inglés al Español, a continuación, del español al francés, después del francés al alemán, después del alemán al griego, luego del griego al sueco, luego del sueco al portugués, y luego de nuevo a Inglés?
  2. Véritable interopérabilité requiert une vaste série de dictionnaire de données. Sans elle, l'information peut devenir "confus". C'est, séquentielle modifié pendant la transmission. Par exemple, si vous avez pris ces mots et a traversé Google traduire d'une langue à l'autre - par exemple, de l'anglais à l'espagnol, puis l'espagnol vers le français, puis du français en allemand, puis de l'allemand vers grec , puis du grec au Suédois Suédois Portugais après, puis revenir à l’anglais?
  3. Echte Interoperabilität erfordert eine breite Palette von Data-Dictionary. Ohne sie können die Informationen zu "verwirrt". Dies wird sequenziell während der Übertragung verändert. Zum Beispiel, wenn Sie mir das Wort und ging durch Google übersetzen von einer Sprache in die andere - zum Beispiel aus dem Englischen ins Spanische und Spanisch in Französisch und von Französisch ins Deutsche und Deutsch auf Griechisch, dann aus dem Griechischen ins Schwedisch Portugiesisch nach dann wieder auf Englisch?
  4. True διαλειτουργικότητα απαιτεί ένα ευρύ φάσμα του λεξικού δεδομένων. Χωρίς αυτά τα στοιχεία για να "σύγχυση". Αυτό είναι διαδοχικά αλλαχτούν κατά τη μεταφορά. Για παράδειγμα, αν η λέξη και μου περπάτησε μέσα από το Google μετάφραση από τη μία γλώσσα στην άλλη - για παράδειγμα, από τα αγγλικά στα ισπανικά και ισπανικά στα γαλλικά και από Γαλλικά σε Γερμανικά και Γερμανικά σε Ελληνικά, στη συνέχεια, από τα ελληνικά στα Σουηδικά Πορτογαλικά σε συνέχεια πίσω στα Αγγλικά;
  5. Verklig driftskompatibilitet kräver ett brett spektrum av data dictionary. Utan denna information till "förvirring." Detta successivt förändras under transporten. Till exempel, om ordet och promenerade mig genom Google översättning från ett språk till ett annat - till exempel från engelska till spanska och spanska till franska och från franska till tyska och tyska till grekiska, sedan från grekiska till Svenska Portugisiska in sedan tillbaka till engelska?
  6. Plena interoperabilidade exige uma ampla gama de dicionário de dados. Sem esta informação a "confusão". Isso mudou gradualmente em trânsito. Por exemplo, se a palavra e me atravessou tradução do Google a partir de uma língua para outra - por exemplo, de Inglês para Espanhol e Espanhol para Francês e de Francês para Alemão e Alemão para o grego, depois do grego para o Português Sueco em seguida, de volta para Inglês?
  7. Full interoperability requires a broad range of data dictionary. Without this information to "confusion." This gradually changed in transit. For example, if the word and I went through Google translation from one language to another - for example, from English to Spanish and Spanish to French and from French to German and German to Greek, then from Greek to Portuguese Swedish in then back to English?

Pull up Google Translate, try it yourself. Pick additional languages. The results can often be quite amusing.

Senate HELP Committee Chairman Lamar Alexander (R-TN) is running around with his hair on fire these days advocating a delay in implementing Meaningful Use Stage 3 -- the core of his gripe being the lack of progress on "interoperability."

Had we required "Type-O" EHR data at (or close on the heels of) the MU outset, this might by now be a relatively minor issue.

I reflect back a decade to when I first came to Health IT, during the "DOQ-IT" era. HIE/Interop were not even on the radar, but intra-clinic HIT "integration" vs "interfacing" was a hot topic, given that "Practice Management Systems" (PMS) were already fairly common -- Front Office/Back Office apps used for scheduling and patient demographics input and management and claims billing. Given that a lot of clinics had substantial sunk costs in their PMS software, a thriving coding industry arose via which to build and install PMS-to-EMR "mid-office interfaces," in lieu of expensively migrating to fully integrated Front/Mid/Back Office EHRs that are pretty much the norm nowadays (at least in the ambulatory settings). Interface deployments back then comprised a constant source of tech support firefighting.

One can only hope that history will not repeat itself on the interop front. I continue to have my concerns.

Speaking of MU Stage 3 news,
I'm incredibly disappointed we even have a Stage 3. It's just a mistake. It's just prolonging the program. We should have claimed victory, frankly after Stage 1, but clearly after Stage 2, and stopped the program. There's no real additional benefit.
- Former ONC Health IT Policy Committee member, Intermountain Healthcare CIO Marc Probst

The release of the Stage 3 Final Rule broke while I was down in Santa Clara covering Health 2.0 2015. All the "real" press dudes were buzzing about it. I didn't even bother looking into it. I'll get around to the PDF eventually, but, it's a relatively low priority.

More to come...

Sunday, October 25, 2015

Shards of health care, continued

I began recounting my own misadventures as a patient on June 19th here: 'The U.S. healthcare "system" in one word: "shards." The story continued on July 28th in "Healthcare shards update. More sand in the gears," followed by "Shards of health care update" on August 21st.

Since then, I've just been rocking along with my radiation oncology treatment in Pleasant Hill. I'm now 3/4ths done, scheduled to complete my Calypso IMRT tx on November 10th. Not much to report on the administrative/EoB/(non) coordination-of-care front of late.

Until late this week. Relatively minor things, but frustratingly head-scratching nonetheless.
But, first, backing up from that a few days. I went to Walgreens earlier in the week to pick up my two long-time maintenance meds refills. My co-pay came to "$0.00." I can only surmise that I've hit my BCBS/RI $4,600 max OOP for the year. I joked that "I'm going to go see every doctor in Contra Costa County between now and December 31st." Seriously, though, I've now found a new PCP, and will see him on November 19th, at which time I will see about getting full-panel bloodwork and UA done straight away (I will not be using Theranos).
Thursday a bill arrived from "John Muir Medical Imaging" (a 3rd party imaging vendor independent from Muir) from whom I'd not heard since they screwed up the billing on my July endo-rectal coil MRI, regarding which they'd sent me a bill for $2,925, asserting that my insurance claim had been denied. Turns out they'd used wrong physician order number to submit the initial claim. They then informed me they'd re-submit, and not to worry about it. "Just ignore the bill."

Fine. I never gave it another thought. Hadn't heard from them again until this week.

The new bill said "Past due amount, $9.60. Final notice. Failure to remit immediately will result in this being sent to a Collection Agency."


I went to their online payment site, entered my HSA account number, and immediately paid it. There was no "comment" field via which I could let them know what I thought of this.

I waited a while, then cycled back around to the login. "Amount due: $9.60."

I called their customer service number to inquire. "Yes, we see it in the system. It's showing as 'pending'."

Just to be sure, I explained that I'd had payment problems before using our HSA account because because [1] it's in my wife's name (different last name, and through her employer) and [2] the billing address is a P.O. box in Walnut Creek, not our Antioch street address. I also noted that "you people are now threatening me with Collections over $9.60. My wife and I have never had a Derog, our Bureaus are completely clean."

She assured me that they would not send me to Collections over $9.60.


I'll have to log in yet again to see that the payment cleared. I've recently remitted nearly a thousand dollars in OOP to my RadOnco facility. I'm not about to blow off $9.60 chump change. I have been fastidious in remitting my legit balances.

That was Friday morning. After my Calypso tx, I had my weekly meeting with my oncologist. We discussed the FloMax thing, and decided it was time to try it, to try and mitigate the up-every-two-hours-all-night urinary hassle resulting from being so baked by the tx.

He wrote me a scrip. I recall thinking "OK, uh, no e-Rx here, 'eh? Whatever."

They use MOSAIQ, an Oncology EHR system.  Interfaced to their Elekta RadOnco equipment. Below, my Elekta Calypso x-ray bug zapper.

The MOSAIQ EHR is ONC Certified, but, still, I got a paper scrip.

Which would shortly come back to bite me in the butt.

I showed up at Walgreens in Antioch at 12:45 pm and handed in the Rx. The clerk looked at it, entered it, and said "it will be ready at 2:15."

I showed up again at 3:05, just to make sure I'd given them enough time.

"I show that this prescription could not be processed. It was not dated." They indifferently refused my request that they call the doctor and resolve the situation right then. His number was right there on the scrip. They would "have to fax them for a response."

I posted my reaction a bit later on the Walgreens Facebook page (I've found that publicly rubbing vendors' noses in their BS on social media typically works better than going through their "customer service" web and phone channels).
I just got jerked around at your store in Antioch California (Hillcrest location). I'm going to take my Rx business henceforth to one of your competitors. I am under treatment for prostate cancer. Today my radiation oncologist wrote me a prescription for FloMax. I took it to the pharmacy, the clerk took it and told me it would be ready about 2:15 PM. I came back a little after 3 PM, and was told that the physician had not dated the prescription, so I could not pick it up. Ok, stuff happens. I replied "fine, his phone number is right on the prescription. Call him." I was told that they would have to fax a request over to the physician's office and wait to hear back. The last time I checked, this was the 21st-century, not the 20th. This is not acceptable customer service. They told me they "could not call him." That's crap. Make that "would not call him." I am in my seventh week of radiation treatment, and I don't feel like running around back-and-forth all day trying to get a simple prescription filled.

This little episode will also go on my blog, at, where I chronicle my misadventures in the healthcare system from time to time ("Healthcare Shards") during the course of my writing about health information technology issues.
In less than an hour, there was a response.
Hello Bobby, I am very sorry to hear of the trouble that you've experienced. I've documented your concerns and forwarded this information to management for review. If you'd like to receive a response, please Private Message your contact information. Thanks -Monica
To which I replied.
My contact information is quite public. My principal email is My home phone hard line is already in your system. My cell phone number is [xxx–xxx–xxxx]. It is now nearly 6 PM on Friday evening, I guess I will not be hearing from Walgreens in time to pick up this prescription tonight. I am not happy about this. I held off going with this prescription as long as I could, but now I feel like I need it. But, owing to the indifference of one of your employees, I will have to do without it for yet sometime to come. This issue could have been proactively resolved by a simple phone call when it became noted that the date was missing. A phone call would have taken less time than putting together and sending a fax and then waiting for and processing a reply.
To which they responded, also on Facebook:
Thanks for the information @ Bobby Gladd. I've updated your case with; your contact information and your feedback and asked for a response as soon as possible. - Belinda
Since then, crickets. No phone calls, nothing in my Walgreens portal in-box.

I suppose now I will be apprising my RadOnco people of this when I arrive at daily tx tomorrow, and will be asking for a new, properly dated scrip.

I will not be taking it to Walgreens. Moreover, after my initial visit with my new PCP next month, I'm gonna ask that my routine meds orders be re-written and routed elsewhere. There are both a Rite-Aid and CVS closer to the house anyway. This doc is on Epic, so I know he can do e-Rx.

But, wait! There's more!

Frustrated, I left Walgreens (where they were not offering flu shots) and headed over to CVS on Lone Tree Way, where I'd gotten a flu shot last year. Handed the pharmacy clerk my insurance cards.

"Well, Mr. Gladd, it seems that BCBS will pay for the vaccine, but not for the injection. So, effectively, it's not covered."

I'm not making that up.

"Can I just drink it?" I joked.

I paid the $54.99 retail. Had to have it. I'd wasted enough of my Friday chasing my tail, and was feeling very tired by that point. For one thing, I'm going to  Minnesota next weekend for my grandson's "Senior Day" final home football game at St. Olaf. Feeling pretty zapped these days from all the radiation. Whatever protection a flu shot might provide while sealed in a plane with a bunch of coughing and sneezing kids, I need it.

"Won't pay for the injection."


They were out of the flu nasal spray alternative (which would have been covered), so it was a shot or nothing.



Jus' for grins, I logged into my account on the Walgreens portal.

Okeee-dokeee... No phone call, to either my cell number or hard line. No email notification. Probably a weekend shift hand-off disconnect. I suppose if there's still time to get the Rx tonight, I will first need to call them to verify so I don't waste yet another 45 minutes or so and a couple bucks worth of gas.

Nope. "The pharmacy is now closed."

My wife's advice?


Everyone who has to engage the health care non-system as a patient has his/her tales of frustration (recall my citing of Steve Brill?), even a prominent physician like The Incidental Economist's Aaron Carroll, MD.
Trapped in the System: A Sick Doctor’s Story
September 23, 2015 at 8:00 am, Aaron Carroll

We spend a lot of time talking about various metrics of quality or access in the American health care system. The problem with many of them is that they rarely seem to capture the issues that people face in dealing with care. Although many metrics are improving, problems remain that still seem insurmountable...

lived in constant fear of not being near a bathroom. The half-hour commute to my job often necessitated a stop on the way to work because I feared I would lose control of my bowels. My wife could tell you many stories about how I made innovative use of my babies’ diapers in cases of emergencies.

But a number of years ago, after I found that drug after drug didn’t work, my gastroenterologist suggested an older immunosuppressant. I’m a doctor, and I recognized it as a drug often used to treat cancer. It carried with it some significant side effects, most notably a small chance of myelosuppression, in which your bone marrow shuts down and produces too few blood cells.

That horrified my wife. But she didn’t appreciate that this was, to me, a small price to pay for the opportunity not to be constantly worried about my proximity to a toilet. I weighed the benefits versus the harms. I decided to give it a go...

The medicine is old and it’s generic. It costs about $80 for three months even though I haven’t met my deductible. But this story isn’t about money. This is about the nightmare of how hard it is for me to get the drug.

Every three months, I run out of my medication. In order to get more, I need a new prescription. In order to get the prescription, I need to have lab testing to prove to my doctor that I don’t have anemia. This all sounds simple, and it’s the same process every three months. But it’s never the same, and it’s never easy.

Let’s start with the lab testing. At various times, my insurance plan (which is excellent, by the way) changes which laboratory facilities it will cover fully. Often, these are not labs that are housed in the huge health care system for which I work. I often have to go elsewhere to have my blood drawn. If I change facilities, I have to get a new prescription for the labs, since they can’t share with one another.

Further, even though my lab orders are good for a year — and I need to have them drawn basically forever — the labs recognize them for only six months. So sometimes I have to get in touch with my doctor and get a new lab order. Often, they send over the old order, because they think it’s good for a year, in which case I have to go back to them and ask for a newly written one, because the lab won’t recognize the really-still-valid old one. Worse, they often just fax the order to the lab itself, thinking they’re helping me, so that I don’t realize they sent over an old one until I’m already there, and it’s too late.

After I get that sorted out, I have my blood drawn and analyzed. But because the laboratory and my doctor are in completely different health care systems, the lab results won’t show up in my doctor’s electronic database. I have to beg the lab to remember to fax over the results — using paper — which it often fails to do.

My next step is to check if the pharmacy I use is still under contract with my insurance plan. The medication I use needs to be ordered at a mail-order pharmacy, because my insurance won’t cover it at a local facility. My insurance plan has changed its mail-order pharmacy of choice more than once in the last few years, which necessitates that I inform my physician about the change.

I also have to open a new account with the new pharmacy and give it my payment information so that it can process everything once it has the order from the doctor. I do this before getting the prescription called in because I don’t want anything to get slowed down. This is a good time to explain that I can’t do much else ahead of time because the pharmacy and the insurance plan both know I have a three-month supply of the drug and won’t authorize me to get more too much in advance.

It’s at this point that I try to get in touch with my doctor, previously through a phone message, and more recently through an online site. If I’m lucky, which usually isn’t the case, the doctor will already have the lab results. If not, I have to go back to the lab and beg it again to fax over the results...
Read the entire article. See also his follow-on post "Answers to your questions about “Trapped in the System: A Sick Doctor’s Story”."

Dr. Carroll seems to be a good guy. I follow The Incidental Economist daily, and I really like his "Healthcare Triage" YouTube series.



Well, finally got my scrip. There's a prominent sign on the pharmacy wall adjacent the check-out area advising patients that all who get new prescriptions are now required by state law to engage in a "consult" with the pharmacist prior to leaving.

The cashier rang me up. $0.00 balance due. She handed me the Rx.

"Bye. Have a nice day."

Whatever. Not that I needed or wanted a "consult."

More to come...

Friday, October 23, 2015

@Theranos: The Empire Strikes Back, sort of.

From the Theranos website:
"In addition to its work as the first lab voluntarily submitting all its Laboratory Developed Tests to FDA, Theranos undergoes continuous proficiency testing on blinded samples from the College of American Pathologists (CAP), American Proficiency Institute (API), and New York State Department of Health. To date in 2015, Theranos Proficiency Testing met or surpassed performance goals 99.5% of the time for CAP, API, and 100% of the time for New York State across 414 assays. Theranos is the first lab to begin publishing this data along with regular updates to it."
They also display a long set of X-Y QC scatterplots for selected analyte parameters, from which I selected six FYI.

"Representative Clinical Correlations - here's how our tests compare to reference methods."
Pretty much uniformly hugging the "reference" diagonal, with high 90's "R-squared" indicators. "R-Squared" is also known as the "coefficient of determination," the square of the Pearson-R Correlation Coefficient, a statistical measure of the extent of Y-axis variability "explained" by X-axis variability (all of which assume normal/bell curve data distributions). An R-square of 1.0 means you hit the reference bulls-eye every time. "Accuracy," recall, is hitting the "bulls-eye." "Precision" refers to how often you can get close results (even if they're inaccurate) in repeated trials.
"We realize our mission only when our tests are performed to the highest standards of quality. The performance of our tests is routinely demonstrated through multiple accredited proficiency testing programs. And despite not being required to do so, we are the first lab that has been and will continue to submit all our Laboratory Developed Tests to the more rigorous standards of the FDA."
The foregoing still beg a lot of questions. e.g., from Wired:
OK, Theranos: Here’s [sic] the Data the World Needs to See
Nick Stockton

I reached out to Theranos, asking them if they’ll be releasing their primary data. Their response: “All of the information we have released at this time is available online; if we release more, we will be sure to let you know.” Since I’m not holding my breath anymore, let’s talk about data.

Data, data, data. If you’ve been following Theranos long enough, you’ll recognize this refrain: a call for transparency so the medical community can verify that Theranos’ technology does what the company claims. When Theranos deigns to respond, it usually says something along the lines of “We have data! We’ve shown it to the FDA! We post it on our website!”

All technically true, but the FDA data shown in that paper are aggregate results, not primary. What does [sic] primary data look like? What does it do? How would you know it when you saw it?...
I have my own. For one thing, each of the graphically depicted Theranos data plot points represents a requisite accompanying "QA package," i.e., the full documentation (paper and electronic) comprising things like end-to-end chain of custody signoffs, as well as records pertaining to instrument calibrations, chemical reagents, standards solutions, and supplies consumed during the specimen runs. Independent auditors would be requesting these at the outset.
Back during my 80's lab days, a scandal erupted when one of our competitor EPA-certified environmental labs was found to have been fabricating results for more than a year, just pouring the samples down the drain and into the incinerators, writing up phony results reports, and simply sending invoices to the clients. They eventually got caught when their reagent/supplies inventory records were examined by auditors and found to be impossible for the volume of samples supposedly run. These dopes thought they were gonna save some money. Instead, they got fined and disbarred.
Another interesting article, from San Francisco Business Times: "Theranos' week offers transparency lesson for 'disruptors' 
...The main question, of course, is whether Theranos' methods of divining test results actually are as cutting edge as the company has claimed. We will discover that in the coming months, but the company has acknowledged that it is running only one test with its finger-prick method while using traditional testing methods for the 200-plus other tests it runs.

Granted, these tests are offered at a cheaper price point than that set by LabCorp or Quest. But that's not the story anymore. The story is about Theranos' finely crafted, even manipulated, message and its secrecy, even to the point of not publishing its test results in a peer-reviewed scientific journal.

That secrecy has come back to stick Theranos like a bad needle, whether or not its tests are indeed as accurate as traditional lab tests...

More to come...

Monday, October 19, 2015

Holmes is no Sherlock. Edison is no Watson. Theranos, continued.

Continuing to follow the story. It's gonna be a tough week at 1701 Page Mill Road, Palo Alto.

From Fortune,
Ex-Apple exec describes first-hand experience using Theranos technology
by  Michal Addady

Jean-Louis Gassée, former head of Apple engineering in the late ’80s, wrote about his personal experience using the technology of Theranos, a multibillion dollar health care startup that aims to revolutionize blood testing. Last week a major controversy arose over the company’s claims.

Gassée has a condition that requires him to get his blood checked often. He was attracted to Theranos because it markets itself as an inexpensive and painless alternative to regular blood tests. After visiting the hematology lab at Stanford University, Gassée went to a Walgreens store to try out the Theranos method. The results he received were significantly different than what he saw at Stanford.

Gassée continued his experiment by returning to both locations the next day to test his blood. The Stanford results had changed, but not significantly so. The Theranos results, on the other hand, were strikingly different from both the Stanford results and the previous day’s Theranos results.

Curious about the reliability of this technology, Gassée wrote a letter to Theranos founder Elizabeth Holmes, stating his findings and saying, “I find the price and convenience of Theranos services attractive, but I worry about the reliability of the important HCT number,” referencing the “hematocrit” number, which measures the volume percentage of red blood cells in the blood. He asked about the company’s methodology, standards, and quality controls, and gave Holmes a chance to respond before publishing an account of his experience. He never received a response, he said...
Lab Test Firm Theranos Offers Weak Rebuttal To WSJ Charges
By Clayton Browne, ValueWalk

Medical lab test company Theranos offered a rebuttal to the critical article about the firm published in the Wall Street Journal last week, but most analysts and experts were not impressed.

The “rebuttal” was notably short on details or proof, and Theranos continues to claim any kind of details about its new Edison small-sample blood testing technology, including the number of tests that are currently performed with Edison, are “trade secrets”, which just adds to the growing cloud of uncertainty and potential fraud surrounding Theranos and it ultra-ambitious founder Elizabeth Holmes...
$10 Billion Health Startup's Board of Directors Lacks Medical Expertise
by Lydia Ramsey, Slate Business Insider

...The company, which is unlike any other, also has a board whose makeup is unlike that of most other health companies. Its members are:
  • George P. Shultz—former U.S. secretary of state
  • Gary Roughead—retired U.S. Navy admiral
  • William J. Perry—former U.S. secretary of defense
  • Sam Nunn—former U.S. senator who served as chairman of the Senate Armed Services Committee and the Permanent Subcommittee on Investigations
  • James N. Mattis—retired U.S. Marine Corps general
  • Richard Kovacevich—former CEO of Wells Fargo
  • Henry A. Kissinger—former U.S. secretary of state
  • William H. Frist—heart and lung transplant surgeon and former US senator
  • William H. Foege—former director of the Centers for Disease Control and Prevention
  • Riley P. Bechtel—chairman of the board of the Bechtel Group Inc., a construction company
  • Sunny Balwani—president and COO of Theranos
  • Elizabeth Holmes—CEO and chairman of the board of Theranos
To make sure we got all that: that's six former government officials, two former military leaders, two corporation leaders, two members of Theranos' leadership, and two men who graduated from medical school. As my colleague Kevin Loria writes over at Tech Insider:

"The caliber of the board suggests that Theranos must have developed a transformative innovation, but other than Frist, who has not practiced medicine in many years, only Foege is a medical professional."...
Here we go again with those gushing "Free Beer Tomorrow" words and phrases. "Transformative innovation," "revolutionize,' disruptive," etc. One of my Facebook comments over the weekend:
This is what you get from inadequate regulation and transparency. I cover a lot of this high-tech cutting-edge healthcare stuff for my blog. I know that Theranos has repeatedly rebuffed Health 2.0 requests for them to present at the H2.0 conferences.

And, as I observed on another thread: What would be truly "innovative" would be widespread availability of the so-called "lab on a chip" smartphone technology, where you could cheaply do your own blood and urine tests at home without any need for any intermediary whatsoever. The Theranos business model still sees THEM as the intermediary, simply taking market share away from the large incumbent laboratory vendors. That doesn't strike me as all that "innovative" over the long haul. And, now, if it is in fact verified that they've been gaming their PE data, then they have a very, very serious problem. And not just with the regulators. The big IPO payday may never happen. Their responses thus far are not very reassuring. It will be interesting to follow developments in the story. A big Epic Fail may be in store.
Going back to Matthew Holt's THCB post that started this thread:
Whether or not Theranos is lying, cheating, not using its own tech, or its cool stuff just doesn’t work, the trend towards comprehensive, cheap and soon at home lab testing is clear. More than 5 years ago a company called BioIQ was selling at home fingerstick based cholesterol & glucose tests. In the past year the two stage Nokia Sensing XCHALLENGE (of which we hosted stage 1 at Health 2.0 in 2013) has revealed a plethora of companies taking minute quantities of blood, pee or spit and doing complex diagnosis from them. And it’s not stopping there. The next phase is using light and other sensors to diagnose direct from the skin. Whether or not the locus of activity ends up using Theranos at Walgreens or the kitchen table using something else, the dam holding back continuous, cheap multi-faceted testing is going to burst soon. 

It seems to be that to be honestly classified as an "innovative, transformative disruption," a health care technology would have to be [1] less expensive, [2] more convenient for the customer/patient, and, [3] more accurate.

[1] Theranos touts their pricing transparency and "lower" costs.
"You wouldn't go to a grocery store that didn't have price tags. Why should getting a blood test be any different? At Theranos our prices are always online and available. They are a fraction of other labs. And if you have insurance they are often less than the co-pay. It's all part of making lab testing as accessible as possible."
Fine. I note that they list their PSA assay at $12.65. LabCorp notified me last time they'd be charging $198 for that single parameter test. Notwithstanding that I had to leave a credit card number with them, they subsequently accepted about $19 contract rate from BCBS/RI (no balance billing). So, yeah, Theranos would be about a third lower.

[2] Convenience. While not fully "DTC," (Direct to Consumer), if all I have to do is go to a Walgreens rather than shlepping through another several-hours-out-of-my-day primary care visit just to get a lab slip, that's clearly more convenient (and much cheaper, net, particularly given my not having to incur another 99213 encounter charge, something I griped about in my "Shards" post).

The other "convenience" facet touted by Theranos is the putative quicker turnaround time. Well, I now have to submit to an annual "wellness screening" encounter at my wife's office so we continue to get our BCBS/RI premium "discount." Yes, it's more "convenient" (and cheaper) than going to the doc. They sloppily do your Vitals (BP through my right arm shirt sleeve? Seriously?), allow you to self-report height and weight (seriously?), and then whip out a thin sterile glass pipette (about the size of a cocktail swizzle stick) with a sharpened beveled business end. A quick alcohol swap on a fingertip, followed by a quick little stab, and you watch the blood flow into the pipette, which is subsequently inserted into a small desktop device about the size of a cable set-top box. A couple of minutes later you have cholesterol parameter estimates.

By no means an Edison analytic Swiss Army knife, but, same "convenience" idea. "Revolutionary"?

[3] Accuracy. That's really the entire regulatory rub here. The rest is just marketing copy/venture capital puffery.

How do we determine whether bioassay specimen results are tolerably "accurate"? In particular those now being churned out by the now-beleaguered Theranos?

Well, there's a mature QA/QC science going to that, regarding which I wrote in my 1998 grad thesis. e.g.,
The terms “accuracy” and “precision” are not synonyms. The former refers to closeness of agreement with agreed-upon reference standards, while the latter has to do with the extent of variability in repeated measurements. One can be quite precise, and quite precisely wrong. Precision, in a sense, is a necessary but insufficient prerequisite for the demonstration of “accuracy.” Do you hit the “bull’s eye” red center of the target all the time, or are your shots scattered all over? Are they tightly clustered lower left (high precision, poor accuracy), or widely scattered lower left (poor precision, poor accuracy). In an analytical laboratory, the “accuracy” of production results cannot be directly determined; it is necessarily inferred from the results of quality control (“QC”) data. If the lab does not keep ongoing, meticulous (and expensive) QC records of the performance histories of all instruments and operators, determination of accuracy and precision is not possible...

A “spike” is a sample containing a “known” concentration of an analyte derived from an “NIST-traceable” reference source of established and optimal purity (NIST is the National Institute of Standards and Technology, official source of all U.S. measurement reference standards). A “matrix blank” is an actual sample specimen “known” to not contain any target analytes. Such quality control samples should be run through the lab production process “blind,” i.e., posing as a normal client specimens. Blind testing is the preferred method of quality control assessment, simple in principle but difficult to administer in practice, as lab managers and technicians are usually adept at sniffing out inadequately concealed blinds, which subsequently receive special scrutiny. This is particularly true at certification or contract award time; staffs are typically put on “red alert” when Performance Evaluation samples are certain to arrive in advance of license approvals or contract competitions. Such costly vigilance may be difficult to maintain once the license is on the wall and the contracts signed and filed away...
I just would like to see Theranos' PE specimen and internal QC data. How about some "transparency" there?

Why should I not be holding my breath?
Is Theranos $9 Billion Worth of Hype?
by Steve Tobak, FoxBusiness

"[T]he company has never published any peer-reviewed papers in medical journals discussing its methods or demonstrating how its results compare with traditional methods."
I hope they can satisfactorily explain all of this. I'll repeat: If Theranos gamed their PE samples and internal QC data and the CEO knew it, they have a very big problem.

FDA tells Theranos to stop using its tech except for approved herpes test
By Nicole Gray | October 19, 2015

  • The FDA recently showed up at Theranos, which is based in Palo Alto, CA, and told the company that the "nanotainers" the company uses to collect finger-pricks of blood are considered unapproved medical devices.
  • Theranos has submitted more than 100 proprietary tests to the FDA for approval, but only one—for herpes— approved.
  • Adding to the company's woes, Theranos has also been audited by the Centers for Medicare and Medicaid Services (CMS), which is the main regulatory overseer of clinical labs...
Stay tuned.


"Eventually there is no place to hide." - Michael Moritz

From the San Jose Mercury News' Michelle Quinn:
Quinn: Time for Theranos and Elizabeth Holmes to open up
By Michelle Quinn

Her firm, Theranos, promised to revolutionize consumer health, starting first with making blood testing easier and more affordable. But right now, its name, a mixture of the words "therapy" and "diagnosis," and its lofty promises are in crisis mode and it will take more than good marketing and lawyering to steady the ship...

"Holmes' drive to change the world has a familiar ring here," I wrote at the time. "She may actually do it -- or not. It's always hard to know in Silicon Valley whether the hype matches the reality."

And now, doubts are reaching a fevered pitch with critics and tech pundits questioning the fundamentals of Theranos as well as its prospects for growth...
Theranos' integrity matters to the people who rely on the company for testing of their blood -- and all the personal diagnostic information contained therein, of course.

But there is another reason for its integrity to matter: Investors, students and entrepreneurs in the diagnostic testing realm and beyond need to know what is real about Theranos and Holmes, which have received a considerable amount of attention...
Excellent piece. Read all of it.

No one's asking them to show their schematics and engineering drawings to the regulators and competitors. Just performance evaluation specimens with a tight chain of custody, so that we can be sure the samples were actually run on their own (or industry-standard) equipment. This whole "proprietary" secrecy thing is a red herring. 

Cheryl and I both worked for a number of years in a laboratory in Oak Ridge, where a lot of our bioassay samples were to serve as evidence in court cases (radiation and mixed waste contamination and exposure litigation). So, we know exactly how this quality control and proficiency examination process works. We analyzed water, soil, vegetation, air, milk, blood, urine, tissue, and bone matrices, and trained to a forensic standard (Frye Standard at the time). The commercial "clinical" standard this company has to follow is not nearly that strict. If they can't even hit CLIA, CMS, and FDA proficiency/QA targets, they shouldn't be in business.

As Michelle noted in her article, it's time to come clean.


Update 10/21/2015 5:28 p.m. ET: The Journal has responded to Holmes' reaction to its articles with a statement:
We’d like to thank Theranos CEO Elizabeth Holmes for agreeing to an interview today at our WSJDLive 2015 conference, and for the opportunity she gave all of our readers and viewers to hear from her. We always seek full input from the subjects of stories, as we did repeatedly throughout our reporting on Theranos.

Nothing said at the conference by Ms. Holmes refutes the accuracy of the reporting done by John Carreyrou or of the articles, which were subject to the Journal’s rigorous and careful editing process. Contrary to Ms. Holmes’s claims, the Journal shared all facts and anecdotes published in the articles with Theranos before publication, in accordance with our longstanding editorial practice and principles. The company was given plenty of opportunity to respond. Ms. Holmes declined interview requests from the Journal for more than five months, but the general counsel and outside counsel of Theranos provided significant input, which was fairly reflected in the articles.

We note that Ms. Holmes sought to challenge the reliability of our sources, but it remains the fact that she doesn’t know from whom the information for our articles was gathered. We assure her and our readers that our sources were well positioned to know the information they provided about Theranos, and they were vetted before publication.

The Journal reiterates that our articles about Theranos were thoroughly reported, fair and wholly accurate.
Ouch. Wow. I'm sure the Journal is fully up to speed on things like libel, so Theranos is gonna have to do better than they've done thus far.


Coming up shortly, thoughts on my current read.

apropos of several of my prior posts, e.g., here, here, and here. Also newsworthy in light of this: "Watch out, Theranos? Edico Genome CEO backing stealth one-drop-of-blood startup," and this new initiative, ""

More to come...

Friday, October 16, 2015

"P.T. Barnum in a Steve Jobs turtleneck"?

The post title above is from a wisecrack I appropriated from a commenter under one of the articles exploding in the wake of detailed adverse allegations published by The Wall Street Journal about the high-flying (~$9 billion "valuation"?) Silicon Valley "disruptive" blood diagnostics company Theranos.

Hot Startup Theranos Has Struggled With Its Blood-Test Technology
Silicon Valley lab, led by Elizabeth Holmes, is valued at $9 billion but isn’t using its technology for all the tests it offers


On Theranos Inc.’s website, company founder Elizabeth Holmes holds up a tiny vial to show how the startup’s “breakthrough advancements have made it possible to quickly process the full range of laboratory tests from a few drops of blood.”

The company offers more than 240 tests, ranging from cholesterol to cancer. It claims its technology can work with just a finger prick. Investors have poured more than $400 million into Theranos, valuing it at $9 billion and her majority stake at more than half that. The 31-year-old Ms. Holmes’s bold talk and black turtlenecks draw comparisons to Apple Inc. cofounder Steve Jobs.

But Theranos has struggled behind the scenes to turn the excitement over its technology into reality. At the end of 2014, the lab instrument developed as the linchpin of its strategy handled just a small fraction of the tests then sold to consumers, according to four former employees.

One former senior employee says Theranos was routinely using the device, named Edison after the prolific inventor, for only 15 tests in December 2014. Some employees were leery about the machine’s accuracy, according to the former employees and emails reviewed by The Wall Street Journal.

In a complaint to regulators, one Theranos employee accused the company of failing to report test results that raised questions about the precision of the Edison system. Such a failure could be a violation of federal rules for laboratories, the former employee said.

Theranos also hasn’t disclosed publicly that it does the vast majority of its tests with traditional machines bought from companies like Siemens AG...
I came across the news by way of THCB in a post by Health 2.0 co-founder Matthew Holt. My comment there:
Yeah, wow, what an article. Ouch. This kind of stuff is red meat to me. I learned my lab precision and accuracy (they’re not the same) QC basics in a forensic-level radioanalytic lab in Oak Ridge in the mid 80’s (lot of the same screening and confirmatory technologies and methods as in regular clinical bioassay). 

I did my grad work on the scam that is the illicit drug testing industry, e.g.,

Lately I’ve been warning of possible inadequacies in QA within the burgeoning sub-forensic clinical-level “genomics” commercial assay industry, given that there are no federal quality regs in that area. (In Vegas we had this paternity testing company billboard by the freeway near downtown featuring a huge picture of an infant with a Photoshopped Pinocchio nose. Tagline: “Who’s The Daddy?” LOL.)

This Theranos thing is a whole ‘nuther concern. Far more basic, but equally important. Cheap, “innovative/disruptive” lab testing, well, bears close scrutiny.
Everyone is jumping all over this. Go to Google news and simply search on "Theranos" and then sort by date.

From The Washington Post:
A comprehensive guide to Theranos’ troubles and what it means for you
By Carolyn Y. Johnson and Ariana Eunjung Cha October 16

A deeply reported story by the Wall Street Journal has pulled the curtain back on Theranos, the hot and intensely secretive Palo Alto, Calif., company that aims to revolutionize how we get our blood tested. The newspaper's investigation raises questions about the accuracy and also the novelty of what the company is doing. Here's a guide to the growing questions about this company, the industry, and why it matters.

What is so innovative about what Theranos claims it's doing?

When you get your blood drawn at the doctor's office, it's often sent off to an external laboratory to be tested. Theranos captured the attention of busy consumers, doctors and investors when it announced it had developed a technology that could provide results for nearly 200 tests with only a single, capsule-sized amount of blood drawn by a finger stick rather than a needle in the arm. Moreover, the company claimed that it could do the testing faster (in less than four hours) and cheaper than traditional labs.

But the company's appeal has been as much about its founder's efforts to empower consumers as about Theranos technology. Elizabeth Holmes, Theranos' chief executive, is a Stanford dropout who is believed to be America's youngest self-made female billionaire. She has touted the potential benefits of being able to order blood tests on your own without going through your doctor. In 2013, the company announced a major partnership with Walgreens to offer its tests at wellness centers located at the retail centers. In April, Arizona passed a law allowing any lab test to be ordered without a physician's request. Theranos' tests are available to consumers in 42 Walgreens in Arizona and one in California.

What's at stake for the blood testing industry?

Blood diagnostic tests, ranging from a herpes test to cholesterol checks, are a huge industry, valued at about $75 billion in the United States. The market is projected to grow to $90 billion by 2018, according to Divyaa Ravishankar, a senior industry analyst at Frost & Sullivan.

The biggest piece of the business -- about two-thirds -- come from blood samples taken outside hospitals, according to Michael Cherny, a managing director at Evercore ISI. About half of that testing is done by independent labs -- a $25 billion, fast-growing market, which is dominated by two big companies, Quest Diagnostics Inc. and Laboratory Corporation of America (LabCorp)...
CEO Elizabeth Holmes at TedMed last year.

UPDATE: From the L.A. Times,
...In a widely viewed video of a talk she delivered last year at TEDMED, Holmes describes on-demand blood tests as an issue of personal empowerment. "When people have access to information about their own bodies," she said, "they can change outcomes."

That sounds unexceptionable, even laudable, but healthcare is more complicated. As John P.A. Ioannidis of Stanford Medical School observed for an article in the Journal of the American Medical Assn., Holmes' talk ignored the drawbacks to expanded consumer-driven blood testing, such as "overdiagnosis, false-positive findings, or the potential for ... misplaced and perhaps overly zealous diagnostic and screening efforts."

As it happens, questions had been raised about Theranos' claims for months — but they had been swamped by a tide of fawning publicity. Ioannidis noticed that information about Theranos had appeared in the Wall Street Journal, Business Insider, Fortune and Forbes, "but not in the peer-reviewed biomedical literature."

In many articles, the company's choice to develop its technology secretly, as "stealth research," was treated as a virtue. But to Ioannidis, it presented a risk: "Stealth research creates total ambiguity about what evidence can be trusted in a mix of possibly brilliant ideas, aggressive corporate announcements, and mass media hype."...
So, beyond quasi-DTC "overdiagnosis" concerns, several big potential summary issues: [1] it looks like they've been doing most of their specimen runs on industry-standard assay equipment rather than their "proprietary" "Edison" machines they tout as the "innovative/disruptive" cost-cutting game-changer.

[2] More importantly, serious questions pertaining to accuracy and precision have arisen.

You get a set of labs back, you need to be able to assume they're as accurate as can be. Your harried docs will simply take the numbers at face value and advise you accordingly. Bad labs get you bad advice.

[3] Most potentially damaging of all, whistleblower allegations have come forth asserting that Theranos gamed their accreditation proficiency specimens ("PE samples"). The WSJ article:
Whether labs buy their testing instruments or develop them internally, all are required to prove to the federal Centers for Medicare and Medicaid Services that they can produce accurate results. The process is known as proficiency testing and is administered by accredited organizations that send samples to labs several times a year.

Labs must test those samples and report back the results, which aren’t disclosed to the public. If a lab’s results are close to the average of those in a peer group, the lab receives a passing grade.

In early 2014, Theranos split some of the proficiency-testing samples it got into two pieces, according to internal emails reviewed by the Journal. One was tested with Edison machines and the other with instruments from other companies.

The two types of equipment gave different results when testing for vitamin D, two thyroid hormones and prostate cancer. The gap suggested to some employees that the Edison results were off, according to the internal emails and people familiar with the findings.

Senior lab employees showed both sets of results to Sunny Balwani, Theranos’s president and chief operating officer. In an email, one employee said he had read “through the regulations more finely” and asked which results should be reported back to the test administrators and government.

Mr. Balwani replied the next day, copying in Ms. Holmes. “I am extremely irritated and frustrated by folks with no legal background taking legal positions and interpretations on these matters,” he wrote. “This must stop.”

He added that the “samples should have never run on Edisons to begin with.”

Former employees say Mr. Balwani ordered lab personnel to stop using Edison machines on any of the proficiency-testing samples and report only the results from instruments bought from other companies...
Theranos lawyers are now circling the wagons. I bet there are now "Crisis Management Consultants" on board as well. People are choosing their words ever-so-carefully, while also pointing fingers at the big incumbent lab players.
“Stories like this come along when you threaten to change things, seeded by entrenched interests that will do anything to prevent change” - Theranos
I guess we'll see. While that is undoubtedly true (corporate espionage and the gamut of competitor skulduggery), particularly in inadequately regulated markets (think no further than the Gresham's Dynamic poster child, Uber), spare us the poignant Shocked Surprise and Dismay. Hel-lo? SWOT analysis/Risk Management 101, anybody?

More. From TechInsider:
Here's exactly what we know about how Theranos' 'revolutionary' technology works
Kevin Loria

On Oct. 15, a bombshell investigative report by the Wall Street Journal alleged that hot startup Theranos, founded by Elizabeth Holmes, was mostly relying on traditional technology to analyze blood test results.

Later, on CNBC's "Mad Money," Holmes said that as part of a voluntary transition to getting its tests approved by the Food and Drug Administration, the company stopped using its proprietary "nanotainers" to collect fingerpricks of blood — though some reports indicate that pressure from the FDA was what fueled that decision.

Many of these reports have observers wondering whether Theranos' supposedly revolutionary blood tests work at all.

Until either Theranos shows the data that Holmes has said disproves allegations from former employees that its tests don't work as well — we've requested that data multiple times — or until the FDA releases their decisions on the other approximately 130 tests the company has submitted for review, we won't know the answer to that question.

What we can do is look at existing science and expert opinion to try to make an educated guess about how these blood tests are supposed to work.

This past April, Tech Insider talked to experts in the fields of clinical pathology and laboratory medicine, microfluidics, and biomedical engineering to try to piece together an answer.

No one could figure it out conclusively, because as Dr. David Koch, president of the American Association for Clinical Chemistry and a professor at Emory University, said then, "It may be wonderful [or] it may bomb, but I really can't be more definitive because there's nothing to really look at, to read, to react to."...
Read the entire TechInsider piece.

More. From Wired...
Theranos’ Scandal Exposes the Problem With Tech’s Hype Cycle

THERANOS, A COMPANY that makes low-cost blood tests, has been celebrated as the inventor of the next major medical breakthrough, and its founder, Elizabeth Holmes, has been hailed as the next Steve Jobs. But in an expose published today, The Wall Street Journal portrays Theranos as a company that is not only grossly under-delivering on its promise, but is also working hard to hide its problems.

A months-long investigation by the Journal found that, for the bulk of its blood tests, Theranos has not actually been using its own technology, which the company has claimed are capable of running tests with only a few drops of blood. Instead, it’s been relying on traditional machines from companies like Siemens. What’s more, the article alleges that in proficiency tests, Theranos’s own Edison machines have produced radically different results than traditional machines have, and internal emails reveal the company may have tried to prevent those inconsistencies from seeing the light of day.

The Journal‘s claims, many of which Theranos has contested, are damning, portraying Theranos as an Oz-like company that looms large in public consciousness but turns out to have little going on behind the facade. At the same time, the story also exposes a deeper problem with the way Silicon Valley tries to spin hype into startup gold.

It’s hardly unusual for a startup to over-hype its potential in its early days. Mark Zuckerberg was crowing about connecting every person in the world long before that claim seemed plausible. Uber executives have been talking about taking over the taxi industry for years. Even Tinder sometimes bills itself as a global social network, not just a dating app. These grandiose promises are table stakes in the tech industry, a requirement for luring both investors and early users. And typically, they’re harmless. After all, who really gets hurt when, say, Ello fails to catch on?
 But Theranos is a cautionary tale of what happens when that mentality creeps into sectors other than software, such as medicine. As one Theranos patient quoted by the Journal put it, “trial and error on people, that’s not OK.” It’s not that any of this is done maliciously. It’s just that the tech industry wants its heroes. It wants to find the next Steve Jobs. It wants to be responsible for discovering not just the next big chat app, but the next big idea that will change the world. Once the industry finds a protagonist who seems to fit that narrative, the story can take on a life of its own, separate from the more mundane reality...

The latter two paragraphs, precisely. I harbor no ill will toward this young woman (unlike, say, the arrogant cutthroat Enron 2.0 types at Uber). Maybe she's just gotten played by people who work for her. Silicon Valley sharks, after all, are not exclusive to the Pacific waters just to the west of Sand Hill Road. I've cited her previously a couple of times. See, e.g., my January post "Failure is the Siamese twin of innovation" - Jonathan Bush.

From CBS News:
"The sources relied on in the article today were never in a position to understand Theranos' technology and know nothing about the processes currently employed by the company ... We are disappointed that, in an effort to make its story more dramatic, this reporter relied only on the views of four 'anonymous' disgruntled former employees, competitors and their allies, instead of reaching out to many of the scientific, health care and business leaders who have actually seen, tested, used and examined our breakthrough technologies."
Ahhh... the tried and true "disgruntled former employees."

Fair enough. Let's trot these other people out, CVs and Theranos ties in tow for all to see and evaluate at an extended news conference replete with lengthy Q&A.


From TechTimes:
...Due to the lack of scientific transparency and suspicion over the voluntarily submitted data to win approval of their methods, the FDA made an unannounced inspection of the Theranos lab. The FDA later announced that the Nanotainers used to contain the finger-pricked blood sample is "an unapproved medical device."

Moreover, Theranos uses standard lab equipment purchased from external vendors to do their tests, and not their own Edison machines. Under pressure from government regulators, the tech startup has ceased operations using the proprietary technology to collect tiny blood samples, with the exception of the herpes simplex 1 test, which was FDA-approved in July.
This will certainly be interesting to follow. Wafts of VW? Questions of relative "innovativeness" and concomitant marketing puffery aside, if they in fact gamed their PE samples and she knew it, well, she and her company have a very, very big problem.


Surprise FDA inspection at one of Silicon Valley’s hottest startups Theranos
Theranos is stopping its revolutionary blood work technique after being blindsided by the inspection.

Federal officials showed up unannounced to the facilities of super-hot startup laboratory Theranos, slapping its revolutionary pinprick blood vials as “unapproved medical devices.”

Now, Theranos is halting work on its brand new blood test technique, which involves using tiny vials to collect droplets of blood through a pinprick rather than large vials of blood from a traditional needle in vein procedure, according to a Wall Street Journal report...
The big IPO Payday is starting to look a little iffy. Perhaps.

From The New Yorker:
The Secrets of a Billionaire’s Blood-Testing Startup

As far as corporate origin stories go, the blood-testing company Theranos has a pretty good one. Its founder, Elizabeth Holmes, quit Stanford in 2004, as a sophomore, to dedicate herself to the company. Over the next decade, Theranos attracted hundreds of millions of dollars in investments. Former senior government officials, including Henry Kissinger and George P. Shultz, joined its board of directors. A partnership with Walgreens envisaged Theranos “wellness centers” in thousands of stores across the country. As the company’s valuation soared, Holmes took to wearing Steve Jobsian black turtlenecks, and was proclaimed “the youngest self-made female billionaire in the world” by Forbes. All of this rested on the idea that the company could revolutionize the seventy-five-billion-dollar diagnostic-lab business, by developing new kinds of tests that were quicker, cheaper, and required much less blood than their predecessors.

On Thursday, the Wall Street Journal presented a different story. Citing four anonymous former company employees, among other sources, the Journal’s John Carreyrou reported that Theranos has “struggled behind the scenes to turn the excitement over its technology into reality.” Rather than a tale of technological and commercial triumph, Carreyrou told one of wonky equipment, skeptical employees, legal threats, and evolving standards of “marketing accuracy.” According to the Journal, as of late 2014, Theranos was running less than ten per cent of its tests on its own machines. The rest of the tests were being run on old-fashioned machines, purchased from old-fashioned manufacturers like Siemens AG. In a bizarrely clumsy move for a multibillion-dollar company, Theranos deleted several claims from its Web site while Carreyrou was reporting his article, including a sentence that read, “Many of our tests require only a few drops of blood.”...
The hits just a-keep on comin'...

More to come...