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Her songs are the ones I most like to sing to in my car. The bridge of this one is especially satisfying.

Walk to the bus music

I’m am so meetinged out. 🤪

Have a Pink Martini:

The hinky thing about Theranos @preetbharara

While we wait for the jury in Paul Manafort’s trial to convict his ass, and fret, justifiably, about Trump revoking the security clearances of national security experts who reasonably believe him to be a treasonous idiot and aren’t afraid to say it, let us turn our attention to the case of Elizabeth Holmes and Theranos.

Theranos is (was) a startup company that promised to run accurate assays on dozens of blood tests with a finger stick. Elizabeth Holmes was a Stanford drop out who came up with the idea and the device, got many high name backers, and sold it to medical facilities everywhere. At one point, Theranos was worth $10 billion.

Then unsettling news started to leak about her gizmo. Specifically, her publications were thin to non-existent and the presentations on the data were amateurish.

She was eventually indicted for fraud because the device did not work as advertised, putting millions of patients potentially at risk.

Preet Bharara’s Stay Tuned this week focuses on the Theranos case. He interviews John Carrey of the Wall Street Journal about the history of Theranos. Very interesting. This interview exposes some uncomfortable truths about Theranos, venture capital and journalism.

Let’s take the last first.

Carrey makes a point that as a medical journalist, he has a better sense about Theranos than the typical journalist. 🙄. Like many of his ilk, he makes a big deal about credentials and the fact that Holmes was a college drop out and didn’t have any publications blah, blah, blah.

Those are not character flaws or limitations. I’ve worked with some fantastic medicinal chemists who got hired during their undergrad internship and never finished their degrees.

I know plenty of researchers who have a remarkable record of achievement who can’t publish because their work is proprietary, patentable and jealously guarded by lawyers.

As for her ability, there are tons of publications and youtube classes and other resources that are online and free so that anyone who is sufficiently motivated and insightful could come up with a magical blood testing device that kinda sorta works.

These are not limitations. In fact, if anything, other women who are interested in starting their own company could have gone the Holmes route. More power to them. That’s how we make breakthroughs. Your lack of credentials should not be a limiting factor. You can learn just about anything if you want to. In fact, if we took the attitude that only people with multiple degrees should be considered credible, then Steve Jobs and Bill Gates would have been serving burgers instead of creating technology that everyone uses.

I can’t even fault her iterative design. That’s a big buzz term these days but while it’s somewhat new to technology, it’s just another way of saying scientific method. There’s nothing wrong with putting out a device that works well for one test and then as you improve the device, you add more tests.

The problem with Theranos and why I don’t buy her aspirational, selfless “for the common good” defense of her fraudulent actions is I haven’t heard anything yet that says the FDA or any other regulatory agency approved her device for sale for something as serious as blood tests.

Nope. Nada. I’m still waiting for someone to tell me what agency approved it.

That’s where she would have had to show her work, just like all of us labrats have had to do. We have lab notebooks that are signed and co-signed.

She could have done that.

We make presentations and show all our work and data and sometimes years and years of clinical results. And sometimes, even that isn’t enough to get a new drug or device approved. The bar on safety keeps rising. It’s difficult to keep up. But we all understand and take seriously, our responsibility to show that our inventions are safe and efficacious.

Apparently, Elizabeth Holmes didn’t have to do that before she started selling her blood test machines. Her clinical tests were real world. And I’d like to know why. How did she get past the regulators? Did it have anything to do with her early backers at the conservative Hoover Institute who has deep ties to government entities and knew what buttons to push and which ones to avoid?

Oh, sure, when people started to question how her black box machine worked, she had to start make presentations that were found wanting and required further investigation. But by that time, she had sold many machines and made a fortune for herself and her early backers.

And I think this is where we come to the core of the problem. In order for Holmes to do this legit, she would have had to have done much of the research and gotten the data before she sold a single unit. Venture capitalists ain’t got time for that. It takes time and money, Gobs and gobs of both, before a single machine is sold.

Holmes, a young woman without a degree would have had a very hard time getting venture capital for a long term investment. Somehow, she met with the right people who didn’t think that would be a problem.

That’s the problem, Preet. Someone(s) knew where the loopholes and took advantage of them. They can proclaim innocence and good intentions until they’re blue but they still managed to skirt the regulatory process. And that’s a bad thing that should alarm all of us.