Theranos Halts New Zika Test After FDA Inspection | Hacker News Reader

Theranos Halts New Zika Test After FDA Inspection

wsj.com

78 pointsdankohn133 comments

Click bait title?

Theranos withdrew their application to the FDA for the test. So "Theranos Halts New Zika Test" is technically accurate, but it suggests that the test was actually being performed.

> a company news release[0] said Theranos had collected finger-stick blood samples from patients, including in the Dominican Republic, and run the tests on the new miniLab device, which showed that the Zika test worked.

From the news release:

> The company collected finger- stick samples from subjects, including in the Dominican Republic, and shipped those to Palo Alto to run on the miniLab.

0: https://news.theranos.com/2016/08/02/theranos-unveils-diagno...

Brutal mistake, it sounds like their product probably actually works in this case too but they just can't follow the rules.

“We hope that our decision to withdraw the Zika submission voluntarily is further evidence of our commitment to engage positively with the agency,” said Dave Wurtz, Theranos’s vice president of regulatory, quality and clinical affairs.

And in other news, their general counsel stepped down.

" FDA approval of the miniLab would allow Theranos to sell the device for outside use even if she is banned from owning or running a lab for at least two years."

Scary...

Would be very worried to see any Theranos device being used for anything that impacts on clinical decision making..

Theranos needs to die and Ms Holmes needs to go back to university.

How long until people go to jail? I don't see how Theranos can get out of this downward spiral due to its attitude of disregarding laws and even ethics. If they really want to help people they should try to do no harm first.

Lobbying money? Who knows...

You have people on the Theranos board of directors who have commited much worse than what the company has been accused of recently. For example, Henry Kissinger:

"In June 1999, by order of President Bill Clinton, the State Department released thousands of declassified documents[79] revealing for the first time that the CIA and the State and Defense Departments were intimately aware of Condor"

Who is Henry Kissinger and what is Operation Condor? https://en.wikipedia.org/wiki/Operation_Condor

If the architects of such chaos in Latin America have never been charged, I don't think they ever will be. Of course the 'puppets' (Pinochet and other cronies) got some form of 'justice' applied to them in recent years, but what they got does not even amount to a slap on the wrist ...

Wow another blow to Theranos. I'm surprised they are still in business.

On another note, someone in the wsj seems to really hold a grudge against Theranos and/or Elizabeth Holmes.

Edit: Warren to Holmes mb

> On another note, someone is the wsj seems to really hold a grudge against Theranos and/or Elizabeth Holmes.

I suspect because they were, at one point, on the receiving end of her wrath. She strikes me as a Carly Fiorina, Jr., and not even remotely above pulling some contacts to exert some backhanded political pressure on people she doesn't like.

Not all reporters are idiots. And some of the reporters who cover specific areas are pretty close to experts in their own right. If you try to feed them a line of bull, they're going to smoke you.

The relevant line is: “Never argue with a man who buys ink by the barrel”

There's a big difference between a grudge and a where-there's-smoke-there's-fire scenario.

I don't think there needs to be malice here. They do need to sell newspapers and Theranos cultivated a high profile media image so people are interested in them.

So Zika, a devastating illness that is likely to cripple thousands, will go on being undetected because Theranos may have not quite followed the rules in collecting finger sticks? This is a public health emergency. Appalling.

Not quite.

1. Their tech is _deeply_ unproven. Theranos doesn't even use it internally, and the sanctions against them in the past year have been very instructive about that. They have exactly zero publically disclosed, peer-reviewed pieces of evidence that detail the clinical use and efficacy of their primary technology.

2. Thou Shalt have an IRB [0]. No exceptions. The tuskegee experiment[1] and other utter failures of medical ethics in this country is why.

[0]: http://www.hhs.gov/ohrp/regulations-and-policy/regulations/4... [1]: https://en.wikipedia.org/wiki/Tuskegee_syphilis_experiment

It's such a basic mistake that I can't imagine any legitimate researcher making it. I helped out with a project that anonymously surveyed registered dietitians about their knowledge of listeria. It had to go to through the IRB before we started, and then any change to it required an IRB amendment. It is unbelievable how big and how basic of a mistake they made, it makes me question what other corners they cut.

exactly. I've had to be aware of IRB needs since high school, and deal with them since I was an undergraduate.

This is like trying to run a business but "not knowing" that you have to issue your employees W-2s.

IRB, for those like me who didn't know, stands for institutional review board.

I spent 10 years in the medical research world. Not having IRB approval is such a basic error. IRBs are set up to ensure that all research conducted on humans is safe and ethical. If this was not Theranos and someone was say giving high level of radiation as part of an experiment I doubt you would be as forgiving. Or maybe PII gets published as part of a study on STDs and people are publicly identified. IRBs exist to protect patients and prevent researchers from harming them, either intentionally or unintentionally.

We're talking a finger stick here.

Think about that for a moment. If you can test for the virus with a finger prick, you can potentially transmit this and other viruses as well. That needs to be addressed in the protocol, along with any other relevant details. It should be mundane. That's why it's shocking to hear that they did not do it!

IRBs exist to ensure that these sorts of things are not overlooked. Too many times in the past, they have been. So now the burden of proof lies with the investigator.

Like it or not, a few fast-and-loose protocols ensured that this situation will not be changing any time soon.

You're also talking about telling someone they either do or do not have a disease. The finger stick alone is not all the damage that you can do. Is that person pregnant? Is their spouse? Are they going to act on what you told them?

Or, another way to think of it is that a company that has already harmed people with false claims about the suitability of nanotainer technology in medical screening is prevented from doing further damage because they still can't manage to clear even the lower bar the FDA the has set for approval in such public health emergencies--a lower bar that other vendors have managed to clear for their already-approved Zika tests.

What? Are you kidding me? The law is the law. The regulations are there for a reason. The people you should be mad at here are Theranos if you really think they were going to do something good, they are the ones who screwed up.

I'm not comfortable with companies skirting the law "because it's an emergency."

Looks like Theranos just needs to just more knowledgable people...

"The FDA has cleared Zika tests from several other companies since invoking a rule allowing the agency to lower hurdles for new medical products during emergencies."

And all of the responses and negativity skate around the positive results and the tragic loss of an effective diagnostic procedure. Because 'rules'.

The oversight (potentially risking folks safety by not doing a finger stick with the right paperwork?) has nothing to do with the actual medical test nor does it compromise the results. Yet everybody is fine with punishing an unpopular company because of yes technicalities. While public safety and the lives of unborn children are at serious risk.

I don't get the nerd mentality sometimes. Common sense flies right out the window.

There are other companies who followed the rules and do have a successful test for Zika. A company with Theranos history should have been following the rules, knowing they had already screwed up. They're currently, unless their appeal succeeds, going to be barred from performing ANY testing for 2 years. Actually the fact that they are under appeal makes failure to follow procedures even more astounding.

The question is, why is this bar a problem for them and not others? Inability to follow a basic protocol is a good sign of their incompetence with regard to deeper issues I suspect.

Thalidomide was also banned in the US "because rules".

Common sense in medicine prioritizes doing no harm.

I can provide other notable examples if need be. The bottom line is that all parties need to be confident that the expected benefit of a test or procedure outweighs any expected potential harms. Having multiple layers or peer review is one way to ensure this.

I work on clinical trials of "black label" (potentially lethal) agents in patients that typically have no other options. Our pages can be 70-100 pages and we are doing this in our "spare" time (Ha! Ha!). I don't think it's unreasonable for a massively capitalized private company to produce documentation at least up to this standard.

It really isn't much to ask, especially for an existential venture like this (something -- anything! -- trustworthy to recover the tremendous amount of credibility they've lost.)

Other companies had no problem writing a suitable protocol. Why should peoples' safety be compromised just so that an untrustworthy company can enter the market?

We're talking a finger stick here. And a devastating illness that is poised to become a worldwide epidemic.

For which other diagnostics exist from companies that somehow managed to submit a proper protocol.

Unlike Zika tests, it is extremely rare for patients in the trials I design to have any alternatives. Also unlike Zika, the standard of care in the diseases I work on yields less than 25% 5-year survival.

Not birth defects (horrific though they may be) but death from organ failure and infection. Nearly all of the compounds are known or potential teratogens. No alternative sources for most of the drugs. Still need an IRB.

You say, "oh it's just a finger stick!" To which I must say, have you looked at the number of physicians and nurses who got Hep C or HIV from an errant finger stick in the hospital?!

And I come back again with "Mothers and babies and a worldwide epidemic"

"tragic loss of an effective diagnostic procedure"

Theranos' last attempt at an effective diagnostic test for the effects of warfarin caused at least one stroke in a patient due to inaccurate results.

Both false positive and false negative Zika virus tests would have equally undesirable ramifications.

How many women would you like to have Theranos harm with their implementations that have been well documented to be appalling ?

First, do no harm.

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