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EVERYTHING YOU NEED TO KNOW ABOUT THE THERANOS SAGA SO FAR

  

Category:  Health, Science & Technology

Via:  community  •  8 years ago  •  18 comments

EVERYTHING YOU NEED TO KNOW ABOUT THE THERANOS SAGA SO FAR

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In the beginning, Theranos was called Real-Time Cures. Corny? Sure. But Elizabeth Holmes was barely 19 when she came up with it, a Stanford dropout aspiring to upend personalized medicine. Besides changing its name, Theranos has come a long way: It’s raised hundreds of millions of dollars, signed deals with huge consumer health companies, received federal approval, and been the subject of glowing profiles in some of the world’s most prestigious publications.


Theranos has also been the subject of a damning Wall Street Journal investigation that attacked the company’s credibility , its business plan , and its  technology . Theranos is a complicated, secretive company that is caught up in a scandal because it may have broken esoteric regulatory rules , and violated fundamental guidelines for  how science is done . Its saga is fascinating. Also confusing. So it’s best to just start at the beginning.


 

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Larry Hampton
Professor Participates
link   seeder  Larry Hampton    8 years ago

Multiple tests from a single drop of sample is the medical lab-tech's golden goose. We are constantly searching for new methodology and technology to improve our craft. Holmes looked to be a rising star who would revolutionize medicine in profound ways; but, instead, succumbed to greed and pressure. How very disappointing.

 
 
 
Kavika
Professor Principal
link   Kavika     8 years ago

Always follow the money.

 
 
 
Petey Coober
Freshman Silent
link   Petey Coober    8 years ago

Did she simply move too fast without doing the required scientific proof ? 

 
 
 
Larry Hampton
Professor Participates
link   seeder  Larry Hampton  replied to  Petey Coober   8 years ago

No.

The Lab itself had many discrepancies. Some of these are rather bland errors...QC not followed-up on. procedures not being followed, appropriate recording not made....stuff like that. Stuff that nearly every lab, medical, pharmaceutical, research, whatever, has to deal with. A lab might get a couple of minor insufficiencies like this; Theranos though had many, many,,,,enough to make the lab work itself appear very sloppy and shoddy, not at all professional.

That's not all.

After suspicions were raised more investigations revealed that indeed the test results were not only incorrect, but in some instances straight out fabricated. The more problems with the tests that were discovered, the more cover-up that took place. A lot of the comparison studies with other methodologies were also rigged or made-up. The QC revealed that they were not just errors in transposition or recording, but actual problems with the tests themselves.

Then...

They (Theranos/Holmes) also then lied to investors about the success and results of the testing as well. Most times in the US there is a lot of leeway given to investment opportunities to thrive or fail on their own merit without government intervention. In this case however it looks as if the Fed is wanting to make an example of her. She is going to be crucified.

 
 
 
Petey Coober
Freshman Silent
link   Petey Coober  replied to  Larry Hampton   8 years ago

Just off the top of my head : it sounds like the lessons she learned at school were about what results medical professionals were most desirous of getting . Science ? Apparently no interest ...

 
 
 
Larry Hampton
Professor Participates
link   seeder  Larry Hampton  replied to  Petey Coober   8 years ago

She understands that right now medical technology is at a very real precipice.

She understands that there is an OCEAN (when it does happen, it will make the tech boom look like a traffic-bump) of money and prestige to be had by the one who is able to fill a very real need.

And yes exactly Petey,,,science be damned.

I just can't figure out for the life of me how she thought she could pull it off?!  I think that maybe her ego kept persuading her that she was on the right track, and that she would eventually solve all the problems and be able to sweep the shit under the carpet. I dunno,,,it's a real mystery how somebody so dang smart could be so dang stupid at the same time...

 
 
 
Petey Coober
Freshman Silent
link   Petey Coober  replied to  Larry Hampton   8 years ago

A scientist needs to have a very specific kind of smarts ... and it also requires ignoring a lot of what people want until the science is completed .

 
 
 
Krishna
Professor Expert
link   Krishna  replied to  Larry Hampton   7 years ago

I just can't figure out for the life of me how she thought she could pull it off?!  I think that maybe her ego kept persuading her that she was on the right track, and that she would eventually solve all the problems and be able to sweep the shit under the carpet. I dunno,,,it's a real mystery how somebody so dang smart could be so dang stupid at the same time...

I remember that for quite a while she had people fooled. The general consensus was that she was brilliant! What accomplishments-- and at such a young age.

But actually we've seen this sort of thing before-- and in  many areas, not just medicine.

Sometimes the con artists know they're lying, but they delude themselves into thinking they're simply much smarter than everyone else and will never get caught.

And sometimes they've actually deceived themselves-- total self-delusion. And then they use what they believe to be true to deceive others. (Some of these folks are actually quite brilliant-- yet quite capable of totally deluding themselves).

 
 
 
Larry Hampton
Professor Participates
link   seeder  Larry Hampton    8 years ago

Update:

Now the rubber meets the road as it applies to medical labs.

This colossal FUBAR by Holmes directs light on a very serious and often overlooked issue, namely that of insuring correct diagnostic results. This article is authored by a highly regarded QC master, MR. James Westgard. His name may not be familiar to many; but, to those related to the world of QC and laboratory practice, all know and use Westgaard QC methodology as the primary mathematical tool for doing QC. So it was with great interest that I perused this article. It's loaded with insight about the pitfalls surrounding the Theranos failures, and how the lessons apply to modern laboratory practice in general. Great article for us geeks; yet, also provides life lessons about the medical field and practice in general: When all is said and done, it all comes down to personal accountability moral fortitude.

I have copied nearly the entire article to save one the step of registering onto the free site...

 

Have you been Theranosed? Or are you Theranosing?

The Theranos Scandal is an object lesson for the laboratory industry. It's not only an example of what NOT to do, but also an example of what we risk when we don't demand proof of quality, or what we might suffer if we don't prove the quality we're delivering. We don't want to be Theranosed. And we certainly don't want to be Theranosing others...

Thuffering Theranos!
How to make sure you're not being Theranosed.
And how to prove you're not Theranosing your clients, customers, clinicians and patients

It seems a week cannot go by without more bad news for the former darling startup:

The problems are so notorious that "to Theranos" has now been turned into a verb equivalent " to Enron ."

There’s so much that’s happened that it’s hard to know where to start. Indeed, most of the stories have been covered by other news outlets already, and by real journalists. About the only additional insight we can add here is a closer reading of the lightly redacted inspection report. Because buried in that are some performance details that no one else seems to have noticed.

But before we do that, let's admit that it's more than a little embarrassing that it got this far. That a company that provided no shred of proof of its performance was nevertheless able to market itself to hundreds of millions of dollars of venture capitalist funding and a $9 billion valuation and the Time 100, etc. The laboratory industry remained largely silent when we should have been vocal, challenging, and skeptical.  Instead, we let a startup bully and bluster its way into prominence, and at the same time, claim that all of us in the the laboratory world and diagnostics industry were unnecessary, antiquated, and soon to be driven into obsolescence.

Let’s start with the QC failure rates. The inspection report details that there were significant out-of-control results for many tests, sometimes up to 87% of QC results were out more than 2 SD!!

Knowing these failure rates, we can easily convert those into Six Sigma benchmarks, using the simple short-term scale (a table look up based on the DPM/defect rate)

Recall that the minimum performance required for stable operation is 3 Sigma. Given that, and the inability of any Edison methods to achieve even close to 3 Sigma, we are hardly surprised by the voiding of two years of test results.  Indeed, based on those Sigma benchmarks, you might even predict the unreliability of the results.

But the QC failure rates aren’t the only hidden nuggets in the report. There are also some details on the reported imprecision rates of some other tests.

The report notes that the imprecision for Vitamin B12 at level 1 was 52.5% and level 3 was 48.5%. Already that doesn’t sound good, right? But not put it into context: the “Ricos goal” – a desirable specification for allowable total error of 30%, as well as a specification for allowable imprecision of 7.5%. So the Theranos method exceeds the recommended imprecision by more than 600%!  The imprecision alone is nearly double the allowable total error (even if we accounted for bias, we are in terrible shape).

The inspection note also notes the imprecision for Vitamin D at level 1 was 63.8% and at level 3 was 26.4%.  Again, this doesn’t sound good, but just how bad is it? For that we can consult a paper from 2011:

Adie Viljoen, Dhruy K Singh, Ken Farrinton, Patrick J. Twomey,  Analytical Quality Goals for 25-Vitamin D Based on Biologic Variation, Journal of Clinical Laboratory Analysis 25 : 130–133 (2011)

This paper notes that the most forgiving (minimum) performance specification for imprecision should be 9% and the most forgiving (minimum) specification for allowable total error is 32.2%.

We can further calculate analytical Sigma-metrics by dividing the allowable total error by the imprecision observed. We don't know anything about bias, so we have to assume it's zero for the moment. Even with this optimistic assumption, the Sigma-metrics are terrible:

Thus, the Theranos methods consistently fail to meet even the most lenient goals for precision, and on the Sigma-metric  scale, these methods are achieving mostly below 1 Sigma. Again, it’s not a shock that these test results are being voided.

I also hope it’s not necessary to state that this level of performance is significantly worse than what is provided and observed  in traditional diagnostic platforms. Indeed, many “Traditional” POC devices are also far better in precision and performance than Edison.

Theranos' performance raises many more questions – Why was Theranos hiding this data? Did they understand how bad this performance was? What specifications were they setting for performance and why was this egregious performance considered acceptable?

 At the AACC session, questions from the attending scientists are encouraged, and I hope key questions will be asked about long-term imprecision  observed in the methods, comparison of these results against traditional laboratory instruments (for example, what is the bias between Edison and the Siemens instruments that Theranos has installed and running at the Newark facility?). If we know CV and bias, we can calculate analytical Sigma-metrics and determine the current performance of their methods – and whether or not this company deserves another chance to deliver test results to patients.

But let's not pretend that Theranos is alone in some of these practices, even in the diagnostics industry. There are instrument managers who prefer to hype their quality rather than provide hard facts. There are labs that build a facade of quality but hide an inner core of corrupted quality.

  • If you're dealing with a vendor, demand proof of quality
  • Proof of quality means more than an assertion by the company that of course they provide high quality. You need data to prove it, preferably long-term imprecision, and bias measured against a reference method, peer group or EQA/PT group, and then that needs to be benchmarked against a qualiy goal.
  • Quality data needs to be objective and open - don't just accept it if a company claims world class or Six Sigma performance, read the data that lies underneath those metrics. I've seen examples of a major manufacturer choosing extremely wide goals from one country and then demonstrating Sigma-metrics based on those goals in a country with significantly tighter goals. This is misleading - and if a company is willing to mislead you on their Sigma-metrics, they're probably willing to mislead you on about anything else.
  • Don't just accept the first set of data provided to you by a manufacturer - that might be their optimized, best customer. Ask for multiple examples. Ask to contact the customers themselves and make sure the data is really from that lab. Even better, ask for something like a peer group report from one of the customer (for example, a Bio-Rad Unity Peer group Monthly Comparison Report, as well as its equivalent from other programs from Randox, etc). That data is hard to fake since it's from a third party, and those reports contain all the data necessary to benchmark the instrument performance on the Sigma scale

So those are just a few ways we can avoid being Theranosed by our vendors. But then turn around and make sure you're not committing the same sins with your clients, clinicians and patients.

  • Don't simply claim quality. Provide proof of it, preferably quantitative proof. Sigma-metrics are an excellent way to do this.
  • Don't artificially boost your Sigma-metrics by choosing overly ideal estimates of bias or imprecision, or by choosing quality goals that are wider than appropriate.
  • Make quality part of your investments in operations - don't just by the low bid, the cheapest methods, the cheapest controls - if you don't make quality part of your purchasing process, you will find out that quality isn't a part of the results you deliver.

When we conduct ourselves this way, holding outselves to a higher standard than mere compliance, we will prevent any more Theranos upstarts from gaining footholds in our industry. Innovation has an important role to play in the diagnostics industry, but fraud does not.

 
 
 
Larry Hampton
Professor Participates
link   seeder  Larry Hampton  replied to  Larry Hampton   8 years ago

Make sure you didn't miss this little tidbit...

The announcement that Jennifer Lawrence  has been attached to star as Elizabeth Holmes in a movie adaptation of this sad story, regardless of the fact that we still don’t know

 
 
 
Petey Coober
Freshman Silent
link   Petey Coober  replied to  Larry Hampton   8 years ago

I was thinkin' more of Miley Cyrus in the starring role . She could even show up on a wrecking ball ...

 
 
 
Larry Hampton
Professor Participates
link   seeder  Larry Hampton    8 years ago

Update:

This is the first big public appearance by Holmes since all the shit hit the fan, and rather than explain her actions, she attempted to deflect. Pathetic.

 

Just before Theranos CEO and founder Elizabeth Holmes took the stage in front of a conference room packed with of thousands of skeptical doctors, the PA was playing the Rolling Stones’ “Sympathy for the Devil.” The irony was clear. Since October 16, 2015, Holmes has spent every public moment defending her company against mounting evidence that their drop-of-blood diagnostics service was built on a scientific sham . Many of the people gathered in that conference room at the 2016 annual meeting of the American Association of Clinical Chemistry were probably expecting the company to address those allegations, with data. Instead, they got a box .

The box, called miniLab, is a tidy, humbled version of the mythos that made Theranos a $9 billion unicorn. According to Holmes, it is a glimpse of Theranos’ next chapter, “an inflection point for our company.” Which may have baffled the number of people who thought they had bought tickets for a reckoning. But why not? Theranos’ old business model is dead , skewered by nine months of really bad press, and bled out by a recent federal ruling that bans Holmes from running a clinical testing lab for two years. So, if you take a big step back and look not at where Holmes was speaking—a medical conference—but where she was coming from—Silicon Valley—it’s clear what really happened on that stage in Philadelphia. She pivoted.

------------------------------------------------------------------------------------------

The box Holmes presented today uses analytical methods developed years ago (by other people) to run an unspecified number of tests on a small (but larger than finger prick) volume of blood, obtained by poking a needle into a person’s arm. Holmes did not say how much a miniLab test would cost, nor how long it would take to obtain results. The miniLab is a bunch of standard lab equipment, miniaturized for a doctor’s desktop. “They have some interesting engineering, but not anything that is at the change-the-world level they had previously claimed,” says Stephen Master , professor of clinical and lab pathology at Weill Cornell Medical College. Neat.

 

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Larry Hampton
Professor Participates
link   seeder  Larry Hampton    7 years ago

UPDATE:

Rupert Murdoch cashes in US$125 million of Theranos stock for US$1

Billionaire Rupert Murdoch has sold his US$125 million (NZ$177m) investment in scandal-ridden US blood testing group Theranos for just US$1, according to the Wall Street Journal, which is owned by the media mogul.

Murdoch did not join other prominent investors who collectively put US$600 million into the company in 2015 and have been given additional shares in return for a promise not to sue the company or its founder and chief executive, Elizabeth Holmes, it was reported.

While Murdoch will apparently receive some upside if the company recovers from its various setbacks – which include investigations by regulators and lawsuits by investors – the report does not say whether he is retaining the right to sue the company.

 
 
 
Kavika
Professor Principal
link   Kavika   replied to  Larry Hampton   7 years ago

No bonuses for Fox News personalities, this year, or next year or the next decade.

 
 
 
Larry Hampton
Professor Participates
link   seeder  Larry Hampton  replied to  Kavika   7 years ago

Lol yeah; a 125 million is nothing to sneeze at. Perhaps Christmas jams and jellies will be enough of a bonus this year.

;^)

 
 
 
Kavika
Professor Principal
link   Kavika     7 years ago

I think that Rupert should go bigly yuge.

The original Jelly Bellies, that's what Kelly and Greta would demand. Oh, their no longer with the most trusted name in news. Probably to trustworthy.

jelly-belly-49-flavors-3lb-jar.jpg

 

 
 
 
Larry Hampton
Professor Participates
link   seeder  Larry Hampton  replied to  Kavika   7 years ago

That should work; plus, they are good ol' Ronald Reagan's stand-by snack, so their is a nostalgic taste to them.

;^)

 
 
 
Larry Hampton
Professor Participates
link   seeder  Larry Hampton    7 years ago

UPDATE:

Theranos directors trusted Elizabeth Holmes more than their own eyes

When employees and media started raising concerns, the board did nothing.

When former US Secretary of State George Shultz underwent a Theranos blood test, it involved a standard vein draw—not the company’s proprietary finger prick blood collection. Though at the time Theranos claimed to only use its proprietary testing, the discrepancy didn’t bother Shultz, then a member of the company’s board of directors. In fact, according to newly unsealed court documents  reported by The Wall Street Journal , he continued to believe that the company could and did use its own technology for all blood testing.

“There would be some, you know, excuse about why they needed to take a venous draw for him, but you know, for everyone else it was a finger prick. And, he continued to buy into that,” Shultz’s grandson, Tyler, a former Theranos employee  and whistleblower , testified.

 

Regulators and media reports revealed last year that Theranos  used commercial equipment  for most of its testing and had  critical technical problems with its own technology .

 

 

Denying the reality right in front one's face. The similarities to present political realities amazes me.

 
 

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