Tuesday, October 27, 2015

Tiny samples of blood from a finger prick

The Food and Drug Administration just posted its lab inspection reports for Theranos, the much-hyped blood testing startup that has been facing sharp questions about whether its technology actually works.

The documents are heavily redacted, but it seems the FDA took issue with the company's failure to properly validate its technology.

The FDA also accuses Theranos of using its blood collection devices — known as "nanotainers" — illegally, since they were never approved by regulators...

The reports were posted in response to a Freedom of Information Act request.

These reports, known as a Form 483, are issued by FDA investigators to inform company management of "objectionable conditions" in medical labs.

Specifically, the FDA looks for violations of the Food, Drug, and Cosmetic Act to see if "conditions or practices observed would indicate that any food, drug, device, or cosmetic has been adulterated or is being prepared, packed, or held under conditions whereby it may become adulterated or rendered injurious to health."

In the case of Theranos, it looks like FDA investigators found a number of issues with the lab protocols.


Bowing to criticism, the founder and chief executive of the beleaguered medical testing company Theranos said on Monday that the firm would publish data validating the accuracy and reliability of its tests.
At a conference on Monday night sponsored by the Cleveland Clinic, the chief executive, Elizabeth Holmes, suggested that presenting the data would be more effective than trying to rebut articles in the news media that she said unfairly attacked the company.
It is possible that other changes are coming at Theranos as well. A spokeswoman confirmed that David Boies, a well-known lawyer who has been Theranos’s outside legal adviser, will be joining its board of directors. It was not clear whether he would remain an outside lawyer for the company.
Ms. Holmes, 31, who dropped out of Stanford at age 19 to start Theranos and has since become a billionaire, has been featured on the covers of numerous magazines because of her story and her promise to provide rapid and inexpensive medical testing using tiny samples of blood from a finger prick, rather than big tubes of blood drawn from the arm.
But articles this month in The Wall Street Journal and other publications have questioned how well the technology really works.
Mr. Boies, in an interview with The New York Times earlier this month, said the company had been doing a “minority” of its tests using its proprietary technology. The rest were being done on conventional machines, though that was in part because the company had rapidly expanded the range of tests it offered.
The company, which has been secretive about its technology, has not published data on its test in peer-reviewed journals, the established practice in medicine.
Ms. Holmes has said that Theranos, while not against peer review, was concentrating on submitting its data to the Food and Drug Administration for approval, which it said would represent the best validation.
“If someone’s writing anything, they are writing F.D.A. submissions, and that’s our full-time job right now,” she said last week at the Wall Street Journal Digital Live conference in Laguna Beach, Calif..
But in her talk on Monday at the conference in Cleveland, the Medical Innovation Summit, Ms. Holmes said the company would also publish data.
“We were never against that,” she said. “I just always believed that as the F.D.A. decision summaries came out one by one with our data, that actually that would be so much more transparent a model.”
Courtesy of:  http://www.medpagetoday.com/PrimaryCare/DietNutrition/54317?isalert=1&uun=g906366d4612R5793688u&xid=NL_breakingnews_2015-10-27


  1. The U.S. Food and Drug Administration said privately held laboratory operator Theranos had been shipping a blood testing device under a wrong classification that exempted the product from regulatory control.

    The device in question is the company's Capillary Tube Nanotainer (CTN), a tiny vial used to collect blood from patients.

    The regulator said on Tuesday that Theranos was shipping the device under its low-risk "Class I" category, which includes products such as dental floss, when it should have been classified under a higher risk "Class II" category.

    Medical devices that come under FDA's Class I category are deemed low risk and are subject to little or no regulatory control.

    The FDA said the "uncleared medical device" was shipped across California, Arizona and Pennsylvania.

    The regulator also noted quality audits had not been performed at Theranos's Newark, California facility. (1.usa.gov/1MpBrra)

    Theranos has been in the spotlight after the Wall Street Journal published a couple of stories suggesting the blood-testing startup was relying on traditional lab tools as it struggles with its own technology.

    Courtesy of: http://www.medpagetoday.com/Anesthesiology/GeneralSurgery/54350?isalert=1&uun=g906366d4617R5793688u&xid=NL_breakingnews_2015-10-28

  2. “First they think you’re crazy, then they fight you, and then all of a sudden you change the world,” Elizabeth Holmes, the boss of Theranos, said recently. If she is to change the world, first Ms Holmes (pictured) will have to change minds. In the past fortnight she has faced an onslaught of negative press reports saying that her blood-testing firm’s technology is not all it purports to be.

    Theranos is one of Silicon Valley’s most prominent “unicorns”, or unlisted startups valued at more than $1 billion. Its aim is to disrupt a market for blood tests that, in America alone, is worth $75 billion a year. A recent injection of $400m from investors gave it an implied value of $9 billion. In early October, just before the bad headlines began, 31-year-old Ms Holmes, who is said to be the world’s youngest female self-made billionaire, was featured on the cover of Inc. magazine in a black turtleneck, with the headline “The Next Steve Jobs”.

    Opinion can change as quickly as a pinprick. Soon after, the Wall Street Journal ran a report that Theranos has overstated its technology’s reach and reliability. Theranos has attracted great acclaim because it claims to be able to perform a wide variety of tests by drawing a few drops of blood instead of using a full-sized needle to take larger samples; and because of its promises to make it cheaper and easier for consumers to get blood tests without having to go through a doctor. However, the Journal’s article argued that its tests are not reliable, and revealed that it does only a few tests with its own devices, using other firms’ technology for most of them.

    Ms Holmes said the Journal’s report was “false”, and defended the reliability of Theranos’s tests. But that has not quelled the storm of scepticism. Indeed it gathered force on October 27th, when America’s Food and Drug Administration published reports on its inspection of Theranos. These accused it of distributing an “uncleared medical device”, and registered a few other objections, including that the firm lacked an adequate system for responding to complaints. Separately, GlaxoSmithKline, a giant drugmaker for which Theranos has claimed to have done tests, said that it has not done any business with the startup in the past two years.

    In several respects, Theranos is highly unusual in the tech industry...Its ten-member board boasts George Shultz and Henry Kissinger, two former secretaries of state, but only two people with medical training. The average age of board members is nearly 76.


  3. Biotech sensation Theranos was supposed to be Silicon Valley’s next hot IPO. But late Thursday evening, the company told Fortune Magazine that its board of directors had shrunk from 12 members to five as it battles a perfect storm of negative publicity.

    The new board is comprised of Theranos founder Elizabeth Holmes, Theranos Chief Operating Officer Sunny Balwani, construction executive Riley P. Bechtel, retired Marine Corps General James N. Mattis, and Al Gore’s former lawyer David Boies.

    The Food and Drug Administration just carpet-bombed what was left of the company’s credibility by questioning statements about the risk profile of Theranos’s proprietary blood test, and making 14 “problem observations” regarding the company’s testing lab.

    Theranos was valued at $9 billion as a private company this summer for its supposedly pioneering development of a hand-held device that could test for hundreds of potential medical issues with just a pinprick amount of blood.

    The company gained huge credibility by attracting a very high profile board that included former Secretary of State George Shultz; Chairman of Bechtel Group Riley P. Bechtel; former Wells Fargo Chairman and CEO Richard Kovacevich; former Senators Sam Nunn and Bill Frist; former Secretary of State Henry Kissinger; and former Secretary of Defense William Perry. Theranos also formed a partnership with Walgreens to use its equipment in the Phoenix area as a test market.

    But as Breitbart News reported on October 23, the company may have made numerous false claims earlier this year to gain FDA approval in July to test for herpes simplex virus (HSV-1) using the Theranos “platform,” which consists of hardware, software and blood-drawing equipment.

    Theranos’s test platform was always categorized as a Class II risk device, but the FDA just disclosed that Theranos has been inappropriately advertising its test as an extremely low risk “Class 1” device. Furthermore, in FDA examinations of Theranos labs, the company was subject to 14 Form 483 “problem observations.”

    The FDA reports detail that inspectors of Theranos’ manufacturing and engineering operations from late August through mid-September found that Theranos: 1) failed to investigate or reveal possible failures of its proprietary device; 2) failed to document that its “nanotainers” to hold blood samples were too opaque to inspect for clotting blood; and 3) the company shipped a medical device interstate that not been cleared by the FDA.

    Perhaps the most ominous finding regarding the future of Theranos is the FDA’s determination: “Complaints involving the possible failure of a device to meet any of its specifications were not reviewed, evaluated and investigated where necessary.”


  4. Two weeks ago, Theranos was a blood-testing company frequently associated with adjectives like “innovative” and nouns like “unicorn.” On October 16, the Wall Street Journal published a nearly 3,000-word story about the company that said it didn’t deserve either descriptor. In short, the story said that the company’s claims about its transformative diagnostic technology—painless tests, with faster results, that are comparable to the industry standard—were false.

    A week later, Theranos pushed back against the Journal, attacking the paper’s reporting, reputation, and even its motivations for writing the piece.

    In summary: Them’s fightin’ words. And at this point it’s not so crazy to think that the rhetoric being passed back and forth could eventually land one or both of the pugilists in court. Theranos’ story has moved from the science section to the business section; the next jump is when the lawyers get involved...

    Theranos has some serious legal muscle on hand. Its top representative is David Boies, whom you might remember as the guy who brought Microsoft to its knees in the early aughts, helped make gay marriage legal in California, and advised Sony after it was hacked. Recently Theranos also appointed Boies to its board of directors. (The New York Times reports that Theranos is shrinking the overall size of the board, and losing such luminaries as Henry Kissinger and George Schulz.) ...

    And a libel lawsuit might actually end up supporting the Journal‘s initial article. Theranos would have to present evidence about its technology to the Journal‘s legal team. “There are very serious trade secrets there that the Wall Street Journal has indicated if it had access to it would try to publish,” says Boies. That has always been the substance of Theranos’ explanation for why it wouldn’t show data on how its finger-prick microfluidic technology worked—that the information was proprietary intellectual property. (A gag order might stop these documents from leaking, but the Journal‘s lawyers could fight that as well.)...

    On the flip side, law professors we talked to say Theranos itself could be on the receiving end of legal action. You can lump the potentially aggrieved into three broad categories: the public, the investors, and the government...

    At the same health conference where Theranos CEO Elizabeth Holmes announced Boies would be joining the company’s board, she also said she would release data proving their machines work—the data academics, clinicians, and doctors have been asking to see for over a year, comparing Theranos’ tests to industry standards. Boies says proprietary concerns still exist, but the need to dispel negative public perception now outweighs them. “I think Ms. Holmes has made the right choice in saying we are going to publish this data, because it will finally put this stuff to rest,” he says. It’s definitely what people writing about Theranos have been waiting for.

    Courtesy of: http://www.medpagetoday.com/Psychiatry/GeneralPsychiatry/54393?isalert=1&uun=g906366d4623R5793688u&xid=NL_breakingnews_2015-10-30

  5. In an astounding fall from corporate and political grace, the net worth of celebrated tech “unicorn” Theranos CEO Elizabeth Holmes has fallen from $4.5 billion to zero.

    The calculation was made by Forbes, which put Holmes at the top of its “Richest Self-Made Women in America” list last year. That was, of course, before the Wall Street Journal’s investigative reporting revealed huge problems at her company Theranos, not least of which was the fact that its flagship product didn’t actually work.

    “Our estimate of Holmes’ wealth is based entirely on her 50% stake in Theranos, the blood-testing company she founded in 2003 with plans of revolutionizing the diagnostic test market. Theranos shares are not traded on any stock market; private investors purchased stakes in 2014 at a price that implied a $9 billion valuation for the company,” Forbes reports.

    That valuation came down quite a bit after Theranos was “hit with allegations that its tests are inaccurate and is being investigated by an alphabet soup of federal agencies,” and it was revealed that the superheated startup’s annual revenues are now less than $100 million.

    That makes Theranos worth less than 10 percent of its earlier valuation, and even that assessment might be generous...

    Another blow against Theranos was delivered last week, in the form of two class-action consumer fraud lawsuits from patients who say they were subjected to “unnecessary or potentially harmful treatments,” or prevented from receiving necessary treatments, by the company’s faulty test results...

    ZeroHedge puts the tragedy of Theranos in blunt terms, accusing investors and business partners of being totally hypnotized by Holmes, who is compared to the heroine of an Aaron Sorkin drama. She was an incredibly young, attractive, fast-talking entrepreneur who knew the tech world desperately wanted to believe her Cinderella story. Media and political heavyweights lost their damn minds over the narrative of a self-made woman shattering glass ceilings and revolutionizing the medical industry...

    Holmes shrewdly surfed those political waves, surrounding herself with a phalanx of celebrity board members who didn’t know much about medicine, but had centuries of Beltway experience between them. She also knew everyone from investors to reporters wanted to get in on the ground floor of the next Apple; she even made a point of dressing like Steve Jobs.

    “With a story this good and a heroine this likeable, would you want to be the Grinch raising mundane questions about whether the product actually works?” ZeroHedge asks. Evidently no one did, not even business partners like Walgreens, whose old executives scarcely paused to ask if Theranos technology worked before letting Holmes whisk them off across the corporate dance floor. They have different executives now.

    The cold, hard truth is that without Holmes and her blockbuster political fantasy as marketing assets, Theranos might little to offer that isn’t already provided by established heavyweights in the medical testing industry. Forbes wonders if the company can find a big enough market niche to survive the blow to its reputation...

    There is still a fascinating untold story waiting to be discovered, if Holmes and her executives ever decide to tell it: what did they think was going to happen? Were they gambling that their engineers would somehow find a way to make the Edison system work while they played for time? How could anyone take a such a gamble with the lives of patients on the line?