Have we discussed Theranos?

[ttt]

Can't remember if we'd already discussed this company. It was a story that hit all the perfect notes: young founder who dropped out of Stanford to build a startup, a promise to revolutionize the healthcare industry, super-secretive board stacked with famous people, multi-billion-dollar valuation, attractive young blonde female founder. Except now it turns out that the whole premise of the company may very well be false. 

And basically the whole thing could have been prevented if people just cared enough about peer-reviewed scientific studies. 


www.vox.com/2015/10/31/9646356/theranos-peer-review-evidence


Elizabeth Holmes, founder of the embattled biotech startup Theranos, managed to assemble an influential board, attract a $9 billion valuation, and win accolades from the likes of President Obama and Time magazine — with promises that she could disrupt the multibillion-dollar US blood testing industry with novel pinprick tests.

Recently, however, questions about the reliability and accuracy of Theranos's lab testing arose with an investigation in the Wall Street Journal. Reporter John Carreyrou found that many of the company's revolutionary claims — that it could deliver high-quality test results from just a tiny drop of blood faster and more cheaply than incumbent companies — were overblown and that, behind the scenes, the company was basically operating like a traditional lab. (You can read about the whole controversy here.)

Long before reports about Theranos's dubious practices hit the mainstream media, scientists were calling the company's claims into question in these two particularly prescient papers.

Theranos never published data proving their technology worked

Theranos was skillful at attracting favorable coverage from mainstream media outlets. But the company never backed up those claims in peer-reviewed journals, where they would have received more rigorous analysis from others in the medical community. When asked about the technology, Holmes and Theranos's PR team deflected questions by citing intellectual property concerns and insinuating that any complaints were being planted by rival testing companies such as Quest and Laboratory Corporation.

Other non-healthcare startups may not need to prove their technology by publishing their data, but that's not true in the highly regulated medical space. According to researchers who study diagnostic technology, Theranos's approach was highly unusual. In May, a Toronto pathologist and lab medicine researcher, Eleftherios Diamandis, flagged this issue in the journal Clinical Chemistry and Laboratory Medicine:

The quality of the results are not known since the Theranos system has not been independently evaluated, nor do any published results exist to compare with conventional technologies. New diagnostic tests must be evaluated for their accuracy, precision, specificity and long-term robustness. Trueness and precision (accuracy) need to be maintained over months or years, and monitored by external quality assurance programs, so that patient’s data can be directly com- pared over long periods of time. Without independent validation, Theranos technology’s quality and robustness will remain in question.

He concluded by stating that Theranos's "claims of superiority over current systems and practices are speculative, at best."

In another paper, published in February in the journal JAMA, Stanford researcher John Ioannidis also pointed out that this secretive approach was odd and made it difficult to trust Theranos:

Stealth research creates total ambiguity about what evidence can be trusted in a mix of possibly brilliant ideas, aggressive corporate announcements, and mass media hype. The unquestionable success of computer science, engineering, and social media technologies has created reasonable hope that these technologies can also improve health in ways that the biomedical and life sciences have failed to do until now. But then how can the validity of the claims made be assessed, if the evidence is not within reach of other scientists to evaluate and scrutinize?

In the absence of more scientific transparency, "investors, physicians, patients, and healthy people will not be able to judge whether some proposed innovation is worth $9 billion, $900 billion, or just $9 — let alone if the innovation will improve the health and well-being of individuals."

The skeptical tone of these papers is vastly different from the tenor of positive coverage in most of the mainstream media until a few weeks ago. In a best-case scenario, Theranos will publish its data, as they recently promised to do, and concerns about their accuracy and reliability will be proven unfounded. In the worst case, this will be another example where the public fell prey to an over-hyped health promise supported by no good evidence.

[IIOY]

I've been following this and confess I'm so disappointed. I really wanted a company run by a woman to kick ass on the boys' playground. Plus, I love her idea and wish it would come to fruition.

[ttt]

Nov 2, 2015 9:02:08 GMT -5 IIOY said:

I've been following this and confess I'm so disappointed. I really wanted a company run by a woman to kick ass on the boys' playground. Plus, I love her idea and wish it would come to fruition.

Me too. It really is a great idea, but it sounds like they haven't actually figured out how to make it work.  

[leeba25]

From the linked article with the background info: 

By 2015, Holmes had persuaded Arizona's legislature to pass a law allowing patients to skip right to her labs and order up whatever menu of testing they wanted, without doctors' approval.

It's crazy how influential she & her company were. 

Also, this: 

Carreyrou eventually discovered and reported that it appears Theranos rarely even used its much-hyped Edison technology in its tests. Instead, the startup allegedly relies mostly on older technology by companies like Siemens for the bulk of its testing. (This was in contrast to the company's claims that it used older machines only for "certain esoteric and less commonly ordered tests.")

I don't even know how that works. You go to this lab for a pinprick, and they jab you with a regular needle instead, taking vials instead of drops, and somehow they explain it away? Crazy. 

[ttt]

Nov 2, 2015 9:13:50 GMT -5 leeba25 said:

From the linked article with the background info: 

By 2015, Holmes had persuaded Arizona's legislature to pass a law allowing patients to skip right to her labs and order up whatever menu of testing they wanted, without doctors' approval.

It's crazy how influential she & her company were. 

If you look at who was on her board of directors, it's not surprising. 

www.theranos.com/leadership

One thing you will also notice about the board members is how few of them have any sort of medical background. They're almost all political and defense industry bigshots. Also, 100% men.