Siemens plans IPO of Healthineers during 2018, possibly in US: reports

The long-rumored IPO of Siemens’ healthcare business, dubbed Healthineers, will likely be first half 2018. How CNBC put it was that the IPO would enable “Healthineers to have its own currency for acquisitions and investments as the global healthcare market shifts focus from Siemens’ core business of imaging to molecular diagnosis and patient self-management.” Estimated value is €40 billion (US$47 billion). This separate listing has been delayed, further depressing their share price after a weak quarter. A Siemens board member with responsibility for Healthineers, Michael Sen, said to reporters on the third quarter earnings call that he was positive on the advantages of listing on a US exchange (Reuters).

Healthineers was one of the few bright spots in Siemens’ disappointing quarterly report, with low earnings in their energy related businesses, especially a potential €100 million sales loss resulting from four gas turbines illegally getting up and walking from southern Russia to sanctioned Crimea. We also strongly recommend that Siemens use the time before the IPO to find another name to replace the silly (in English) ‘Healthineers’ (after Three Musketeers? Mountaineers? Out of a Karl May western novel?) Hat tip to Paul Costello.

The Theranos Story, ch. 40: investor fraud revealed in equipment, fake demos, testing

[grow_thumb image=”http://telecareaware.com/wp-content/uploads/2017/04/The-big-dig.jpg” thumb_width=”150″ /]Theranos’ ‘Big Dig’ is larger than this German art installation representing a Hole to China. It was as smooth as the turf depicted. Set up some shell companies, buy equipment from Siemens, modify it to take the mini-samples for the Theranos Edison mini-lab–and run their customers’ blood tests on them. Get incentives from a credulous Arizona governor and legislature. Run fake tests for investors on this equipment. Promise $1 bn in 2014 gross profits. Then, when it all comes undone, tell the investors to take additional equity shares and not to sue, or else it’s Chapter 11. Oh yes, and settle with Arizona for nearly $5 million and CMS for $30,000 [Ch. 39].

The latest reveal in the Theranos Saga took place in busy Delaware Chancery Court in a lawsuit brought by investor Partner Fund Management (PFM) LP and two other associated funds, which invested over $96 million in 2014. The unsealed documents, part of the follow-up to a lawsuit originally filed in October 2016 [Ch. 21] and another filed this month to block the equity offer to investors, contain depositions from 22 former employees and (hold the presses) directors. The (paywalled) Wall Street Journal article revealed that Theranos bought commercial blood testing lab equipment from reputable companies including Siemens, modified them to take the miniature samples that Theranos collected, used them to conduct both customer testing and from the filing, “fake ‘demonstrations tests’ for prospective investors and business partners”. Theranos used a shell company, Protegic Procurement Company, to make the purchases. Former director Adm. Gary Roughead, USN (Ret.), was quoted as being unaware of the fact that there were “extensive commercial analyzers in use.”

Now it is not uncommon for competitors’ equipment to be used for reference purposes and testing, especially when the company still is in process for their regulatory approvals. However, the lawsuit claims that customer tests were run on these labs, and not for a limited time as Theranos claims. The demonstration test claims are even more damning as they show fraudulent intent to investors.

The other part of the PFM lawsuit alleges that Theranos investors, including them, were pressured to not sue and take the additional equity deal [Ch. 38] by an attorney representing Theranos, who suggested that the alternative was to seek Chapter 11 bankruptcy protection. “Theranos officials engineered the share offer in a way that would make it impossible for the funds to obtain “any recovery” as part of its bankruptcy filing.” The PFM filing to block was successful. On April 11, Theranos was stopped from going forward with the share-exchange plan, with that hearing scheduled for June 26, not ideal for a company which is buying time before the money runs out. Bloomberg

The ‘cherry on the fraud cake’ is Theranos’ wildly inflated projection of a $1 billion gross profit in 2014. Theranos, of course, states that “The suit is without merit, the assertions are baseless, and the plaintiff is engaging in revisionist history.” Is ‘fake news’ the next claim? Ars Technica, TechCrunch, Fortune, Engadget.

Rest assured that there are many other chapters to come, as the lawsuits continue, including one for $140 million by Walgreens Boots, and the Colman/Taubman-Dye suit in California. Our Theranos and related articles are indexed here.

The Theranos Story, ch. 22: the human cost of lab error (updated)

[grow_thumb image=”http://telecareaware.com/wp-content/uploads/2015/11/upside-down-duck.jpg” thumb_width=”150″ /]Save this one for the coffee or lunch break. What is the cost of a lab error on the human psyche? It can be mildly upsetting to you and your doctor, warning of a developing condition and some changes have to be made–or make for a very bad day/week/months. It can be falsely reassuring or simply confusing.

We know that in April, Theranos flunked a CMS review, and in May voided all test results from its proprietary Edison devices from 2014 and 2015, as well as some other tests it ran on conventional machines. The results were not only off, but way off, according to the WSJ. “Notes from the CMS inspection show that 834 out of 2,890 quality-control checks run on the Edison in October 2014, or 29%, exceeded the company’s threshold of two standard deviations from its average result. Standard deviation is a statistical measurement of variation. In addition, 80% of the 834 quality-control checks that raised a red flag under Theranos’s internal standards were more than three standard deviations from its average result, the inspection notes show.”

They also failed to notify patients for weeks or months, and often not until forced to. At least 10 lawsuits have been filed in Arizona and California. Some of the human stories of Theranos’ improbable lab results, which included tens of thousands of patients, with the cost of retesting, repeated doctor visits and agonizing suspense :

  • After five widely different Theranos blood coagulation tests in six weeks, a retired marketer living in Arizona and his doctor so distrusted the results that the latter recommended that he stop taking warfarin and switch to a milder medication. This patient found out only last Friday that Theranos had corrected a September 2015 test showing his blood taking more than six times longer than normal to clot. The other four tests showed the warfarin wasn’t thinning his blood enough. Contradictory results confusing both doctor and patient on treatment.
  • A thyroid cancer survivor got thyroxine results (T4) from three tests conducted in October 2014. The extremely high results could have indicated hyperthyroidism at the least, or a more serious condition. The results–false after retesting failed to confirm.
  • A breast cancer survivor had extremely high levels of estradiol, which could have been produced by a rare adrenal tumor that can secrete estradiol or an elevated risk of breast-cancer recurrence. Again, false results but found only after retesting.

The comments under the article are worth the long scroll. (They are running 98 percent in favor of Holmes for Prison 2017. Also there are a few shots at Walgreens’ role in legitimatizing Theranos by putting their centers in store; this embarrassing part of the story isn’t over, in this Editor’s opinion.) What is evident–fraud perpetrated on patients and doctors–and anyone who invested. David Boies, their legal supremo and board member, is gonna have a full docket between this and the various legal actions taken by the Alphabet Agencies.

Agony, Alarm and Anger for People Hurt by Theranos’s Botched Blood Tests. If the WSJ is paywalled, search under the headline text.

See here for the agony of TTA’s 21 previous Theranos chapters. We hope that John Carreyrou and the WSJ investigative team, which we’d assume includes Mr Weaver, this article’s author, are awarded the Pulitzer Prize.

Artificial intelligence with IBM Watson, robotics pondered on 60 Minutes

[grow_thumb image=”http://telecareaware.com/wp-content/uploads/2016/06/robottoy-1.jpg” thumb_width=”150″ /]This Sunday, the long-running TV magazine show 60 Minutes (CBS) had a long Charlie Rose-led segment on artificial intelligence. It concentrated mainly on the good with a little bit of ugly thrown in. The longest part of it was on IBM Watson massively crunching and applying oncology and genomics to diagnosis. In a study of 1,000 cancer patients reviewed by the University of North Carolina at Chapel Hill’s molecular tumor board, while 99 percent of the doctor diagnoses were confirmed by Watson as accurate, Watson found ‘something new’ in 30 percent. As a tool, it is still considered to be in adolescence. Watson and data analytics technology has been a $15 billion investment for IBM, which can afford it, but by licensing it and through various partnerships, IBM has been starting to recoup it. The ‘children of Watson’ are also starting to grow. Over at Carnegie Mellon, robotics is king and Google Glass is reading visual data to give clues on speeding up reaction time. At Imperial College, Maja Pantic is taking the early steps into artificial emotional intelligence with a huge database of facial expressions and interpretations. In Hong Kong, Hanson Robotics is developing humanoid robots, and that may be part of the ‘ugly’ along with the fears that AI may outsmart humans in the not-so-distant future. 60 Minutes video and transcript

Speaking of recouping, IBM Watson Health‘s latest partnership is with Siemens Healthineers to develop population health technology and services to help providers operate in value-based care. Neil Versel at MedCityNews looks at that as well as 60 Minutes. Added bonus: a few chuckles about the rebranded Siemens Healthcare’s Disney-lite rebranding.

Nail in the coffin hammers home: Theranos voids, corrects 2 years of test results

[grow_thumb image=”http://telecareaware.com/wp-content/uploads/2016/04/Yak_52__G-CBSS_FLAT_SPIN.jpg” thumb_width=”150″ /]Tens of thousands of lab results 2013-2015 voided, “corrections” sent. L’affaire Theranos continues, with the not-so-surprising action of Theranos to void all of its Edison machine testing results, from all labs, as well as many processed on conventional equipment during those years.

According to the Wall Street Journal, Theranos told CMS during its lab inspections that they ran 890,000 tests a year, so we are between 1.5 and 2 million tests being, at minimum, voided. The Edison was used for 12 out of 200 tests, at least initially, with conventional machines performing the rest.

The voiding was verified by John Carreyrou of the WSJ by cross-checking his sources with Phoenix-area medical practices (the Walgreens marketing area), which confirmed receiving corrected test reports. One doctor reported that many of the voided results were for calcium, estrogen and testosterone tests. Here is where it cuts to danger levels: “The doctor said one corrected report is for a patient she sent to the emergency room after receiving abnormally elevated test results from Theranos in late 2014. The corrected report from Theranos now shows normal values for those tests, according to the doctor.”

But how can you send corrected results, which would require a rerun, of samples at least a year and perhaps two years old? It’s not clear if this pertains to standard tests run on miscalibrated machines (see below on Siemens) or somehow Edison tests were re-evaluated.

This reads like a last ditch effort to stay out of the Alphabet Monster’s clutches (CMS, FDA, DOJ, SEC), or at least survive their squeeze. COO Sunny Balwani was bid adieu last week, along with the company adding three members with scientific expertise to one of its many boards. Of course, as we previously noted, these boards are Silicon Valley Sock Puppets. The one to watch is legal Attack Dog David Boies (to whom the First Amendment and a free press are so much tissue paper to be ripped) who also sits on the governing board–politically well wired and the kind of bully attorney you call in when you are facing Big Trouble and need Big Defense–or Offense.

Walgreens Boots–reportedly fit to be tied, because Theranos won’t disclose the extent of the corrections, and surely assessing its legal options. Siemens must be equally unhappy that its equipment was 1) miscalibrated by Theranos and 2) Theranos didn’t monitor test water purity; thus they have become inadvertently tainted.

One must wonder if founder Ms Holmes is considering the fit and finish of orange turtlenecks, or residency in a country with no US extradition treaty. For the company, the flat spin above is likely non-recoverable. Sadly, Clipper Theranos will crash down on other, far more honest innovative companies lined up on the runway. Wall Street Journal (if paywalled, copy and search on the headline); Forbes, Ars Technica. Our Theranos dossier here.

Cerner acquires Siemens HIT business

The big news in HIT circles today was Cerner’s purchase of Siemens’ health IT business for $1.3 billion. Forbes has the most detailed analysis by far, which appears prepared in advance based on the 22 July rumor published by HISTalk at that time. HISTalk’s and their readers’ comments on the announcement conference call today are moderately scathing and worth reading if of interest to you. The takeaway for this Editor is that it was a defensive move for Cerner versus Epic Systems, Athenahealth and Allscripts; they bought out a competitor, bought market share with the acquisition (although how much of it would have fallen to them anyway is a question), gained more of an international foothold plus an inside track to customers eager to move to newer technology. For Siemens, it appears  (more…)

Philips, Salesforce dive into health data integration

Philips Healthcare and Salesforce announced last week their partnership to construct a connected, multi-point and collaborative data platform to benefit providers, payers and patients. The initial step is the launch later this summer of the Philips eCare Coordinator app for healthcare providers and a patient-centered Philips eCare Companion app, which will uptake data from Philips Healthcare medical devices into a variation on the Salesforce1 cloud platform. What’s emphasized in the releases and information from media sources is that it will be designed as an open platform for other device and software providers. (Data security problems down the line are anyone’s guess.) While Philips’ global CEO was part of the announcement and it’s expected that Philips will be lead dog for this, the only two customers mentioned were US and Salesforce’s. There were also few details on how clinical staff would access and use the data.

Cui bono from this? Philips of course, which of late has been lagging (more…)