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Theranos CEO Elizabeth Holmes Finally Faces Criminal Charges

It's been some time coming, but the CEO of Theranos is finally facing criminal charges for fraud, as the WSJ's Carreyrou repor...

Showing posts with label theranos. Show all posts
Showing posts with label theranos. Show all posts

Sunday, May 22, 2016

Buying Legitimacy: The Advisory Board

It is a tale. Told by an idiot, full of sound and fury. Signifying nothing.

Macbeth(A5,S5)

Something that seems universal among startups is that, at some point, they'll get negative press - sometimes deservedly, sometimes not. How that company responds to the negative press can also tell you a lot about them and where they are. Clear, concise rebuttals containing facts and data usually serve to dampen any story (and if provided to reporters prior to publication, may kill the story entirely). It's common, however, that companies that hit rocky times have the PR team swing into action and distract from the core questions, never actually addressing the concerns but instead creating fanfare and the appearance of action, but that ultimately mean nothing. One such method is the "Advisory Board".

An Advisory Board is a panel of experienced people in a given field, supposedly there to make comment on an organization's progress or approach within that field - these Boards can be general, for business, IP licensing, technology, media, or any other topic that can affect the company. Done well, these Advisory Boards can serve as an excellent resource for the company and staff, giving advice, providing connections, and a seasoned second set of eyes. 

A company serious about an Advisory Board starts it early in the cycle, before it is needed. The Advisors have recent working knowledge of the field, are compensated, usually with expenses and some stock, and meet on a regular schedule to receive company reports and then give their advice. Relevant staff have direct access to this board, and can use them as a resource when needed. Started early, they become part of the process and grow with the company and teams. The Advisory Board rarely has any actual powers or teeth but rather operates with the goodwill of the staff and executive.

Unfortunately, these Advisory Boards are rarely used for this but instead are either a method of publicity or of assuaging fears. The Advisory Boards are started or populated late in the company cycle, past the time when they can be easily integrated into processes, and perhaps with 'big names' who have not been at the 'coal face' for many years. There is much made in the press of their joining the Advisory Board, but following that, there is nothing they can do or say that is of interest to the company.

For example, Theranos recently expanded their Scientific and Medical Advisory Board with eight new very prominent doctors and researchers, claiming to have fully opened up their technology and processes to scrutiny. "Adult supervision is finally there!" you think upon reading it. But is it really?

How well qualified are they to judge the processes and technology Theranos uses? Microfluidics is a pretty specialised topic, and I don't see any engineers who build those systems there. Generally the end users of the technology, the doctors, don't know how it actually works beyond the basics. Are they capable of finding flaws, or fraud, if it's there? More importantly, how much access are they given to the systems? Is it open, free, and unsupervised, or is it closely restricted and monitored, perhaps shown a specific test? Why is this going to be effective when the actual Board of Directors had a former CDC director as a member? I've seen Advisors look at a very well scripted "show and tell" and then proclaim it a fantastic demonstration, without digging into it themselves. 

Critically - if they find anything, can they speak out publicly and have direct access to the Board of Directors (who should have real power to correct), or does the NDA they inevitably have to sign before seeing the technology restrict this? It's entirely possible that after the initial PR announcement of their joining that they are never contacted again by the company, but they can't even reveal that publicly. Getting someone to sign an NDA, and then showing them just enough of what you do, is also a great way of silencing a potential critic.

In the case of a company like Theranos, there is only one way to truly prove their technology works well - and that's an independent, third party, running standard tests in a remote location, without company personnel there, with guaranteed public release of the results regardless of outcome. That's standard in medical technology - usually multiple studies and peer-reviewed papers presenting the data for all to see.

Energous pull this trick too - for example in 2015 they had Martin Cooper, the "Father of the Cell Phone", join their Advisory Board. It was quite a coup for them, and made for some good publicity. Looking at the investor forums discussing Energous, it's not uncommon for people to write:

"Plus, if Martin Cooper is on board as a Director, The Father of the Cellphone, well, that's good enough for me. "

Quite literally, this person's presence is persuading an individual investor that the company is a sound investment. That's how valuable this type of 'endorsement' is. Like a fading TV star doing an infomercial for real estate or stocks, their name closes the deal. It's used alongside the TED talk, the article in the tech press, and the big name investor - none of which proves anything of value in the company - to cause the critical faculties of investors to switch off.

Sadly, the Advisor often doesn't even realise what their name is being used for. They are often true experts and highly ethical people, who come in with the best of intentions, but with limited knowledge of what's really going on (until after the NDA, then it's too late). It's not committing to a full time job, so they don't scrutinize too hard. They don't understand that the biggest value they give to the company is simply the use of their good name, a name they likely spent a lifetime building. That good name is used by the company to "Buy Legitimacy". 

So when you see companies like Theranos and Energous talk about their Advisors, understand what in my opinion is likely really going on. These aren't adults coming in to sort out the situation, they're generally just window dressing to distract. If these companies were serious about transparency they'd have created the Advisory Board from the beginning, not just during a crisis. To gain the real trust of the investors (and remember, it's all about selling on to a greater fool), they need to do the one thing that would silence every critic, and that's a real public demonstration of their technology.

How many of you expect to see that happening with any of those companies anytime soon? Exactly, so don't be distracted by the window dressing of the Advisory Board, keep asking to see the real results. It's the only honest way to buy legitimacy.

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.

Sunday, May 15, 2016

Theranos 101 - One Tiny Drop Changes Everything


Theranos and Elizabeth Holmes have been discussed multiple times on this blog, and for those not familiar with them I thought I'd give a very quick summary of them and the controversy surrounding them.

Elizabeth Holmes was a chemical engineering student at Stanford when she dropped out at age 19 to start the company - the goal was to create accurate medical tests based on drops of blood rather than vials, so it can be from just a finger prick and not a full vial draw. If it can be achieved, it's a great simplification of the whole blood testing process, and the company hoped it would spur an increase in the number of tests given how easy it would be.

This is not an easy task, and there were significant questions over the ability to accurately do testing on small drops of blood - the drop itself may be so small that even with a perfect test the result may not be accurate or reproducible - but it's a worthy goal for research.

They received some initial seed funding from a regular VC and over the next 12 years developed tests for over 200 conditions, and inked a deal with Walgreens to use the tests in-store, with the PR machine claiming that a revolution in blood testing was coming. By mid-2015 they had raised nearly $700 million which valued the company at around $9 billion, with Elizabeth Holmes as the youngest self-made billionaire. (Note Theranos is a private company so it can be hard to gauge exactly the funds raised, this article estimates $750m)

Holmes was front and center with the company, synonymous with Theranos, and painted as a role model for others. To be compared to Elizabeth Holmes was a great compliment, and entrepreneurs everywhere vied to be 'the next Holmes' - such as this up-and-comer:


It was something of an odd company, with a non-medical board full of former Senators, Admirals, Generals, Secretaries of State and Defense - but not a single person capable of understanding the technology - and going against the grain of almost all biomedical companies never published peer-reviewed results on their tests, simply instead saying (in effect) "trust us".

Now, there had been rumblings from inside the biotech community for sometime that something was not right at Theranos, but the press loved their story of the self-made founder/CEO, and everything was going wonderfully until October 2015 (Fun Fact: Same day I left uBeam!) and the Wall Street Journal released a bombshell story questioning the accuracy of these tests and whether Holmes had been exaggerating the capabilities of the tests. Wired released an article raising the questions that "exposes a deeper problem with the way Silicon Valley tries to spin hype into startup gold."

Startling among these revelations was that Theranos weren't even using their own technology for the tests, but standard off-the-shelf equipment other companies use, as their equipment gave highly variable results.

This was soon followed by other more detailed analysis by the press, along with apologies for prior poor reporting, but more importantly the FDA got involved and stated only one of their many tests was approved (a Herpes test, which is a simple yes/no), and then Centers for Medicare and Medicaid Services wrote to Theranos stating its tests "pose immediate jeopardy to patient health and safety." 

This Business Insider article gives a great timeline of events for Theranos. It has made Elizabeth Holmes, who rode the publicity all the way up and took more of the spotlight than the Company itself, a household name beyond just Silicon Valley and for all the worst reasons. She even has her own parody Twitter account 'NotLizHolmes'

It's been a rollercoaster of negative press for them since then, with damage control from Theranos in the forms of expressing surprise and lack of knowledge, of claiming that data on their tests will be released for public assessment (not happened to date), and that they are working with the authorities to deal with these issue. They added a well qualified medical board too ("look, big names with titles, stop asking questions!"). From an article in the NYTimes, there were some sections that stood out as very familiar to me:

"She (Holmes) stays relentlessly on message, as a review of her numerous conference and TV appearances make clear, while at the same time saying little of scientific substance."

As I've pointed out before - even when you are exposed, stick to the message is the best game plan. But this next section from Professor Frank Partnoy of University of San Diego School of Law was just a stunning quote, what I have been trying to put into words and say in this blog:

“We’re deluged with information even as pressure has grown to make snap decisions. People see a TED talk. They hear this amazing story of a 30-something-year-old woman with a wonder procedure. They see the Cleveland Clinic is on board. A switch goes off and they make an instant decision that everything is fine. You see this over and over: Really smart and wealthy people start to believe completely implausible things with 100 percent certainty.”

You can have experts in the field publish peer reviewed papers, or simple maths that demonstrates the engineering near impossibility of it all, but show a TED talk and an article in Marie Claire and the chequebooks still come out. To quote myself regarding Energous:

"We had, through the use of physics, mathematics, and reasoning, completely demolished their claims and proven that what they are saying is unachievable ... but it got complicated and so you just switched off, ... overall you just didn't care."

To be blunt - technology has gone beyond the capacity for most people to be able to comprehend, even some otherwise very intelligent and educated ones. That deluge of information 'overloads' most people and they fall back on the simplest of solutions - they look for authority figures who have already made decisions for them, or rely on the 'wisdom of crowds' and simply go along with the majority. Actual reasoning shuts down, and following that the idea that someone as smart and educated as you could have got it wrong just can't be entertained (or in the case of existing investors, ever acknowledged).

Something needs to change in how billions of dollars of funding, much originating from retirement funds, is distributed. The system is setup to reward certain behaviours, and good stewardship of this money, and the efficient application of efforts of thousands of workers to benefit our society, in my opinion are not among them. 

Theranos, and others like it, were simply inevitable and the symptom of a much deeper problem.

Tuesday, May 10, 2016

Wasn't Me

So I've been asked why I talk about Theranos and uBeam coverage. Well, it was first brought to my attention around Nov 12 last year when Meredith Perry retweeted a StartupLJackson tweet.
So who first suggested the similarity in coverage? Not me.

Monday, May 2, 2016

Beat me to it

So I was going to do another amazing post about how poor journalistic standards are in part contributing to money being wasted in startups, but Vanity Fair and the Twitterverse beat me to it.

Sunday, May 1, 2016

True Genius

Maybe Elizabeth Parish should start this company with them?

Monday, April 18, 2016

Schrödinger's CEO


Schrödinger's CEO
[shroh:ding:erz siːiːˈəʊ]
noun

A CEO who is apparently both simultaneously a genius inventor of a technology and single handedly responsible for building a business based upon it, yet also completely unaware and has no knowledge of major technological, safety, and business flaws in her company despite it being common knowledge to lay members of the public for years. See Elizabeth Holmes ...

Saturday, April 16, 2016

I'm confused...


I'm confused and don't know what to do. Re-incarnation of Steve Jobs and Theranos genius/founder/CEO Elizabeth Holmes tells me that backup plans are for losers, while the other re-incarnation of Steve Jobs and uBeam genius/founder/CEO Meredith Perry tells me the exact opposite.

"Always have 2 backup plans. Always try 2-3 approaches in parallel to increase your chance of success. "

So not just a backup, but a backup to the backup. And maybe a backup to that too.

So how do I follow the advice of these geniuses? Do I have to choose? I'm always hearing what role models they are, so they have to both be right!

And if it's not both of them that are right, one of them has to be. Because otherwise the only other option is that they are both just spouting utter nonsense they made up because it sounds CEO-ish, and it's been picked up by an unthinking and unquestioning press and simply repeated without thought.


Friday, April 15, 2016

The Sausage Factory


Today is the 6 month anniversary of my resignation from uBeam, a startup I'd spent the previous two and a half years working on. I had gone from being one of the three engineers working in a garage to create the basic technology (literally), through fundraising nearly $23,000,000, and being VP Engineering in one of the hottest tech startups, to being willing to walk away from both a team I had built and was proud to work with, and any chance of recouping the income and opportunities I had sacrificed in getting there.

It marked the end of about four years of working on a several different startups, during which time I made a lot of mistakes, worked on some very interesting things, met some fantastic engineers and other co-workers, and got first hand insight into the workings of VC and startups in tech. It's the last part I find most fascinating - how the whole ecosystem of startups actually works.

I've watched all the recent publicity surrounding Theranos, about a young, media-darling, Steve Jobs idolizing female CEO, who defies the skeptics and without any training in the field apparently makes strides that promise to change the world. Who raises millions on promises of ground-breaking technology that's just around the corner, yet never makes public demonstrations or subjects their technology to third party audit. A CEO of a company that never answers substantial questions raised by veterans in that field, or criticism that they are doing nothing but playing a smoke and mirrors game to fleece the next round of investors, but is more than willing to speak to the press on their 'vision' (and nothing more).

I've followed that story and felt an odd sense of deja-vu about the coverage. How does a company, founded by someone with no realistic credentials or experience, raise so much money on what may never be delivered? Who decides it gets so much press coverage? Surely the VC's are performing their due-diligence and there are adults minding the store?

There's a saying: "You don't want to see how the sausage gets made."

Let's talk about how the sausage gets made...