"As with its previous MiniLab claims, the pitch centred on finger-prick blood samples and a device that"
As with finger-prick blood samples, this paragraph that stops mid-sentence doesn't tell the whole story...
Now that the Olympics is over, there's no apparent athlete-borne Zika pandemic, and the virus doesn't guarantee a headline, Theranos has withdrawn its emergency application to have the Food and Drug Administration approve its blood test for the virus. The emergency approval would have let the company pitch its wares as a Zika …
This Zika chapter in Theranos' already interesting tale is really very informative.
Looking for a way to help turn its reputation around and press forward, Theranos announced a new mini-lab for Zika testing. And, to try to get a PR win they tried to get the FDA approvals rushed through, pleaded the seriousness of the epidemic risk.
Indeed, so hungry for positive spin, they didn't implement correct patient safety measure while collecting the data for the FDA.
And then, with their shot at some quick spin dashed and the publicity boon of the olympics over, they tried to spin their withdrawal of the test as some act of deference and good will beyond the call of duty.
This episode (the most recent in a long line) is damning from start to finish and shows a CEO seemingly bereft of ethics; someone who has a proven record of willfully putting patients at risk for the sole purpose of furthering her own profile.
Being driven and determined and committed to your vision is one thing; putting other peoples' lives at risk to achieve it is quite another. Doing so while weaving a story about benefiting humankind puts it into a league to horrid to even be called irony.
It's certainly narcissistic but it's also bordering on sociopathic.
Quite simply, their own tests were not accurate and even when they used commercially-available testing machines (such as other labs use) they were utterly reckless, failing to follow the safety guidelines and providing patients with questionable results that had not passed appropriate quality-control protocols.
A specific test that struck me was one that is done to measure blood clotting. This was one of the tests that Theranos was unable to even attempt to run with their own systems and so used 'off-the-shelf' equipment. BUT, they were slapdash and sent out questionable results instead of re-checking them as per both the manufacturer's instructions and best practice.
Shockingly, they also used expired reagents. Why is that problematic? Well, the reagents are what causes the chemical reaction that enables the laboratory to identify/measure whatever they are testing for. An expired reagent may react weakly and thus give an incorrect result.
Back to the test itself, blood clotting, this is very important to get right as it is used (amongst other things) to determine the correct dosage of Warfarin, a blood-thinning agent. The reason this test caught my eye - amongst all their other problems - is that for many years, my grandfather relied on Warfarin to prevent another stroke and, you know, not die.
Warfarin is used to help prevent the blood clots that end up in the brain and cause strokes but, as anyone who has ever been cut knows, the fact that blood does clot is remarkably handy, so deliberately reducing its ability to do so is obviously risky. That's why having accurate test results is crucial to ensuring that the correct dose is prescribed.
But, of course, that is just one test in an increasingly long and shameful list of dangerous practices, undertaken for profit and profile at the expense of patient safety.
(And apologies for the spelling and grammatical errors in my original - and likely this - post.)
Thanks Dan, & AC, that makes sense. I wasn't looking at the bigger picture of the company's history, so was wondering about just this one test. It's possible to do this (test a new finger-prick product) ethically even if it gives dubious results, but that involves duplicate testing with the current best practice, and no reliance on the new equipment for diagnosis. So the harm isn't the finger-price machine, but the lack of any ethics surrounding its use.
In this specific instance, their eagerness for a publicity win saw them undertake pre-approval testing (to provide data for the FDA to evaluate) without adequate safeguards for the test subjects, which put them at risk even before the system was out in the field.
So yes, the process - rather than the technology - is the problem here, which is why I used the blood-clot example, as that used approved, third-party systems.
For the Zika test, however, this was specifically a test to prove the effectiveness and safety of their own min-lab, finger-prick systems because that's the whole point: getting their proprietary technology out there so they can spin up some positive PR.
The issue is that gaining that PR was evidently more important to them than patient health, and that is pretty much the MO for this company and its self-aggrandising CEO.
It is shameful behaviour from anyone but doubly-so from a (supposed) health company CEO who calls their clinics 'wellness centers' and who has, for years, painted herself as some humanitarian ushering in a new age of democratised, preventative health care that will benefit all humankind.
Quite simply, she should be in jail.
I've known about this disastrously unethical gold digging dilettante for a while. This is but one in a long line of the CEO's personal ego strokes. I'm stunned that it has not yet been shut down, dismantled and sold off to scrappers for recycling. (no, I'm not that vile, just the company not the CEO). It is however worth noting that the pharmaceuticals industry in the US is *finally* starting to get raked over the media coals in the US for some of the more outrageous pocket lining that has been happening.
Elizabeth Holmes, founder of US health-tech firm Theranos, has been found guilty of defrauding investors after a California jury found she had lied about her company's technology.
Holmes, 37, reportedly showed little emotion when the verdicts were read out. The jury found her not guilty of four charges of defrauding the public, though this was cold comfort when set against the other seven charges of defrauding investors and wire fraud. She has denied the charges.
The trial has had significant impact in California's Silicon Valley, where Holmes' company Theranos had been held up as a multibillion-dollar example of tech changing the world for good. Founded in 2003 by Holmes, Theranos advertised itself as a medical company whose technology could detect diseases using a finger-prick blood test.
Theranos boss Elizabeth Holmes admitted in court this week she personally added Pfizer and Schering-Plough logos to her startup's presentations while trying to seal a deal with Walgreens.
Giving testimony on Tuesday during her fraud trial, the one-time chief exec damningly revealed it was her idea to place the pair of Big Pharma logos on Theranos reports and then send them to Walgreens executives.
Holmes is battling charges she defrauded, and conspired to defraud, investors out of hundreds of millions of dollars by grossly exaggerating the abilities of her company's technology.
Theranos blood-testing machines, which US prosecutors claim failed over 51 per cent of the time, provided no indication if things went awry during demonstrations for visitors, a court has heard.
Seven weeks into the criminal fraud trial of Theranos founder and CEO Elizabeth Holmes, the feds are trying to show that Holmes, along with her former partner and COO Ramesh "Sunny" Balwani (to be tried next year after denying any wrongdoing), raised hundreds of millions of dollars from investors based on misrepresentations about technology that didn't work.
In court on Tuesday, Daniel Edlin, a former Theranos project manager who used to operate Theranos' Edison blood-testing machines, testified that device demonstrations, given mainly to VIP visitors, ran a demo app that hid failure messages.
Attorneys representing Theranos founder Elizabeth Holmes and the US Justice Department presented their opening arguments on Wednesday in a federal court in San Jose, outlining how they intend either to clear or convict Holmes of conspiracy and fraud charges.
Holmes, 37, alongside her former partner and COO Ramesh "Sunny" Balwani, 56, have been indicted on two counts of conspiracy to commit wire fraud and nine counts of wire fraud for their role in the 2018 collapse of blood testing startup Theranos.
The feds allege that Holmes and Balwani – the latter scheduled to be tried separately early next year – defrauded doctors, patients, and investors by making false statements about the capabilities of Theranos' rapid blood testing technology and by withholding information about the technology's shortcomings.
The long anticipated fraud trial of Elizabeth Holmes, the founder of biomed upstart Theranos, got underway in San Jose, California, on Tuesday with Judge Edward Davila asking prospective jurors whether they have experienced "intimate partner violence or abuse" or know anyone has.
Holmes, 37, who served as CEO of the blood-testing biz before doubts about the startup's business surfaced – leading to a civil complaint from the US Securities and Exchange Commission, the shutdown of the company in 2018, and criminal charges brought by the US Department of Justice – is expected to claim she was abused by Ramesh "Sunny" Balwani, 56, her former boyfriend who was also president and chief operating officer of Theranos.
Documents unsealed over the weekend at the request of a lawyer for Dow Jones, parent company of the Wall Street Journal which exposed the problems at Theranos, indicate that Holmes intends to base her defense on her mental state.
Failed blood-testing unicorn Theranos trashed vital incriminating evidence of its fraud, prosecutors said on Monday.
The imploded startup's extensive testing data over three years, including its accuracy and failure rate, was “stored on a specially-developed SQL database called the Laboratory Information System (LIS),” according to a filing [PDF] in the fraud case against Theranos's one-time CEO Elizabeth Holmes and COO Sunny Balwani.
The database “even flagged blood test results that might require immediate medical attention, and communicated this to the patient’s physician,” we're told.
Theranos mastermind Elizabeth Holmes, who is accused of defrauding investors of her now-imploded blood-testing company, will face a jury after all: a judge just scrapped her final attempt to avoid prosecution.
On Tuesday, California judge Edward Davila rejected [PDF] the latest in a long series of efforts by Holmes and her former chief operating officer Ramesh "Sunny" Balwani to limit the US government’s criminal fraud case against the pair. Uncle Sam indicted the duo in 2018, claiming they screwed over doctors and patients as well as investors, and piled on more charges as recently as May this year.
“Defendants have filed six motions to dismiss the second and third superseding indictments,” the judge’s order noted. “This omnibus order addresses them all.”
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