Now the Olympics is over, Theranos is withdrawing its Zika test application

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is over, there's no apparent athlete-borne Zika pandemic, and the virus doesn't guarantee a headline, Theranos has withdrawn its emergency application to have the Food and Drug Administration approve its blood test for the virus.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 …

[DavCrav]

"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...

[Richard Chirgwin]

Thank you, and the corrected paragraph reads:

As with its previous MiniLab claims, the pitch centred on finger-prick blood samples and a device that doesn't need the infrastructure of a pathology lab.

[Magani]

SNAFU, Big Pharma

"Now that the Olympics is over, there's no apparent athlete-borne Zika pandemic,..."

It would seem that the Paralympics don't count then?

[Richard 26]

Re: SNAFU, Big Pharma

The Paralympics don't count as part of the Olmpics, no, because they aren't.

[Magani]

Re: SNAFU, Big Pharma

@Richard 26

I'll quote that bit again: "..no apparent athlete-borne Zika.."

I defy you to go to the paralympics and declare there are no athletes present.

[dan1980]

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.

[AndyS]

While I agree with what you've written, can you explain how a finger-prick test could endanger the recipient? I'm struggling to see why the FDA have a problem here, or what the ethical dilemma is.

[Anonymous Coward]

False positives unduly worrying the person tested; false negatives (leading to treatment not being sought) doing the exact opposite, wasting peoples' cash would be my starters.

[dan1980]

@AndyS

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.)

[AndyS]

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.

[dan1980]

@AndyS

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.

[Alistair]

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.

[allthecoolshortnamesweretaken]

Nice try, Liz. Well, not really, but at least she keeps true to herself. Why does Theranos still exist anyway?