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Thursday, May 19, 2016

Whooops...

Hey, have I mentioned to you a company called Theranos at any point recently? Well, it seems after vigorously defending their product from the awful, nasty, vindictive press, and those "disgruntled former employees with an axe to grind", demanding things like "proof" and "evidence" of accuracy of their tests, that there might have been something to those allegations after all.

"Theranos Inc. has told federal health regulators that the company voided two years of results from its Edison blood-testing devices, according to a person familiar with the matter...

The company has told the Centers for Medicare and Medicaid Services that it has issued tens of thousands of corrected blood-test reports to doctors and patients, voiding some results and revising others, according to the person familiar with the matter.

That means some patients received erroneous results that might have thrown off health decisions made with their doctors."

In summary - they've issued an "Ooops. Our bad."

I'm really shocked to hear all this, because so many people who know CEO Elizabeth Holmes so well, characterized the "attacks" in the press as unfair and unfounded.

Dick Kovacevich, the former Wells Fargo CEO and current Theranos board member, defended the embattled lab testing start-up's boss Elizabeth Holmes on Wednesday.

"I think there will be some information coming out soon that will show that indeed there was misinformation that was put out in the public domain," he told CNBC's "Squawk on the Street," adding what has happened to her is "unfair."

So let me summarise again, since this is so incredible: A company with a reported private valuation of $9 billion just said that their only product, which has been used to diagnose conditions and inform treatments for patients, doesn't work, and that all those accusations that were vehemently denied for months (see Big Lie - basically, "Keep lying in the face of all evidence and eventually people will believe you") are looking to be true.

That the company is abandoning the "Big Lie" means it's game-over. Someone has looked at the data and said "Yeah, it doesn't work" and the threat of actual jail-time means they aren't going to cover it up anymore. All those heavy-handed legal threats to intimidate people into being quiet aren't going to cut it anymore, as people are way more scared of the Feds than they are of Theranos' legal team.

Having worked in FDA governed medical fields, on and off, for nearly 20 years, I'm just stunned that anyone would even think about faking the results on anything that informs patient diagnoses or treatment. Apart from the obvious ethical issues, it's just stupid - you will be found out eventually, they will come after you.  This isn't like a software package where you can just push an update to v1.1 and keep improving it and fixing bugs - it has to be right first time.

The FDA are there for a reason. Sure, regulation is a giant pain, and they can be too bureaucratic and slow, but they are there to protect lives and health from people who would risk you and your family's health to make a quick buck. Safety takes precedence over speed for a reason. This mentality of "we can fix it later, it doesn't matter, just get it out there" has moved from software apps to healthcare. It needs to stop now. This is more than just a "canary in a coalmine", this is "twenty miners trapped in cavein". How long until the "village falls into sink-hole"?

As for Theranos - let me put this simply:

People's health and lives were directly impacted by this. Someone is going to jail.

2 comments:

  1. Unbelievable
    Phase I, Phase II and Phase III tests must be conducted for every new drug before FDA approbation, that means YEARS of controlled testing and peer review.
    How a "magical device" like the Theranos-one was even able to hit the market?

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