The next Theranos should be shortable

A jury will soon decide whether former Theranos CEO Elizabeth Holmes is guilty of a federal crime. But the deeper public policy questions that Theranos raised remain unanswered. How did a startup built on a technology that never worked grow to a valuation of $9 billion? How was the company able to conceal its fraud for so long? And what, if anything, can be done to prevent the next Theranos before it grows large enough to cause real harm—and burns capital that could have been invested in genuine innovations? I explore these questions in a forthcoming paper in the Indiana Law Journal titled Taming Unicorns.

While Theranos was publicly exposed in October 2015 by Wall Street Journal investigative reporter John Carreyrou, insiders knew that it was committing fraud many years earlier. For example, in 2006, Holmes gave a demo of an early prototype blood test to Novartis executives and faked the results when the device malfunctioned. When Theranos’ CFO confronted Holmes about the incident, she fired him. In 2008—roughly seven years before Carreyrou’s exposé—Theranos board members learned that Holmes had misled them about the company’s finances and the state of its technology.

Over time, a remarkable number of people, both inside and outside the company, began to suspect that Theranos was a fraud. An employee at Walgreens tasked with vetting Theranos for a potential partnership wrote in a report that the company was overselling its technology. Physicians in Arizona grew skeptical of the results their patients were receiving, and a pathologist in Missouri wrote a blog post questioning Theranos’ claims about how accurate its devices were. Stanford Professor John Ioannidis published an article in JAMA raising more doubts.

Meanwhile, rumors had spread in the VC community. Bill Maris of Google Ventures (since rebranded as GV) claimed that his fund passed on investing in Theranos in 2013. According to Maris, the firm had sent an employee to take a Theranos blood test at Walgreens. The employee was asked to give more than the single drop of blood that Theranos claimed its devices needed. After he refused a conventional venous blood draw, he was told to come back to give more blood.

So why did none of these doubts slow Theranos’ fundraising? Part of the answer is that it was a private company, and it’s nearly impossible to bet against private companies.

Until the last decade, most startups that grew to become valuable businesses chose to become public companies. Late-stage startups with reported valuations over $1 billion used to be so rare that VC Aileen Lee dubbed them “unicorns” in a 2013 article in TechCrunch. Back then, there were only 39 startups claiming billion-dollar valuations. By 2021, despite the surge in companies going public through SPACs, the number of unicorns had passed 800.

The rise of unicorns has been accompanied by corporate misconduct scandals. Of course, public companies commit misconduct too. Research hasn’t yet established whether unicorns are systematically more prone to commit misconduct than comparable public companies. However, we do know that the opportunity to profit from information about a company by trading its securities creates incentives to uncover misconduct. Since the securities of private companies aren’t widely traded, it’s easier for private company executives to conceal misconduct.

Consider the electric truck company Nikola, formerly a unicorn. In 2020, Nikola went public through a SPAC. Once it was public, short seller Nathan Anderson decided to investigate and ultimately issued a report alleging a pattern of corporate misconduct. He showed that a video Nikola had produced with its prototype truck traveling at high speed was staged—Nikola had towed the truck to the top of a hill and filmed it rolling downhill in neutral. After Anderson released his report, the SEC and federal prosecutors launched investigations into whether the Nikola misled investors. Its stock price lost more than half of its value. In 2021, Nikola’s CEO Trevor Milton was charged by the SEC and indicted by a federal grand jury. Nikola wouldn’t have been exposed so soon if it had stayed private.

Securities regulation restricts both the sale and resale of private company stock in the name of investor protection. Startups usually attach a contractual right of first refusal to their shares, which effectively requires employees to get the company’s permission to sell. Many late-stage startups practice “selective liquidity”: allowing key employees to cash out in private placements, while preventing a robust market from emerging. Consequently, those who have information about private company misconduct have little incentive to publicize it—even though the Supreme Court has held that an investor who trades on information shared for the purpose of exposing fraud can’t be convicted of insider trading.

VCs might seem well-positioned to police unicorn misconduct. But their asymmetric risk preferences undermine their incentive to expose wrongdoing. VCs invest their funds in a portfolio of startups and expect that most bets will generate modest or negative returns, and only a small number will grow exponentially. The outsize growth of the few successful startups will offset the losses of the balance of the portfolio. For VCs, the difference between a startup that implodes in scandal and the many startups that fail to develop a product or find a market is insignificant.

Venture investing is an auction with a winner’s curse problem. Startups pitch to many VC firms in each fundraising round, but they only need to accept funding from one bidder. In public capital markets, if most investors decide that a company is fraudulent or excessively risky, its stock price will decline. In VC markets however, if most investors decide that a startup is fraudulent, the startup can still raise funds from a credulous contrarian. VCs who pass won’t share their negative assessment with the public because they want to maintain a founder-friendly reputation. Maris only told the press that GV had passed on Theranos after Carreyrou’s article.

Congress and the SEC could strengthen deterrence of unicorn misconduct by creating a market for trading private company securities, in three steps.

First, the regulations constraining the secondary trading of private company securities should be liberalized. The SEC should eliminate Rule 144’s holding period for resales as to accredited investors—the individual and institutional investors that the SEC deems sophisticated and most able to bear risk. Congress should eliminate section 12(g)’s requirement that effectively forces companies to go public if they acquire 2,000 record shareholders who are accredited investors—a rule that leads private companies to limit trading.

Second, the SEC should attach a regulatory most favored nation (MFN) clause to all securities sold through the safe harbors commonly used for private placements. An MFN clause would require that, if a company allows any of its securities to be resold, it must allow all its securities to be resold, as long as the resale is otherwise legal. A regulatory MFN clause would ban the practice of selective liquidity and nudge companies to allow their shares to be traded.

Third, the SEC should require that all private companies that let their securities be widely traded make limited public disclosures about their operations and finances. A limited disclosure mandate would protect investors by ensuring they had basic information about the companies in which they could invest, without saddling unicorns with the costly disclosure obligations placed on public companies.

The net effect of these reforms would be to create a robust market for trading unicorn stock among accredited investors. Most large, private companies would likely decide to allow their shares to be traded. Short sellers, analysts, and financial journalists would be attracted to the markets. Their investigations would strengthen deterrence of unicorn misconduct. The limited disclosure mandate, combined with the requirement that investors be accredited, would protect investors.

When large, private companies commit misconduct, the natural response is to increase the penalty for the underlying misconduct, not to interfere with the tradability of the company’s securities. But the problem isn’t lax penalties. Holmes is facing 20 years in prison—a punishment more brutal than anyone deserves. The problem is that penalties only work when wrongdoers expect to be caught. Trading creates incentives to expose misconduct faster.

I get it, Elizabeth Holmes

Elizabeth Holmes’ raspy, deep voice helped her raise more than $700 million for her now-defunct company, Theranos. When I step into any boardroom for a pitch, I can hear her croaking her favorite line: “I hope that less people will have to say goodbye too soon to people that they love.”

Sitting across from a venture partner, I wonder if they might feel more compelled by my words if I cut my hair short (really short), or grew a beard, or removed my pregnant belly. Would they take out their checkbook if I were more aggressive in what I promised? Would they be more interested in getting to know my business and me better if I passionately slammed the table?

Actually, very likely.

Holmes adopted a ridiculously low voice to get her startup off the ground in a world full of men. She promised impossible pinprick tests to detect hundreds of diseases and collected influential investors like Henry Kissinger, George Shultz, James Mattis and Betsy DeVos. She wore a Steve Jobs uniform — including the Issey Miyake turtleneck — and built a team of 800 brilliant people. Did she go overboard with her lies? Yes. But she’s not the only one. The Silicon Valley and venture landscape only exacerbated whatever beliefs she already had in her company and inclinations to promise the moon.

Last week at a virtual hearing, she pushed to keep a huge database of information protected from the government. Before that, she claimed to have made $100 million in revenue in 2014, when it was really $100,000. These things, among others, are hands-down inexcusable. But I still believe that she thought she was doing the right thing taking the universal advice of Silicon Valley: “Fake it till you make it.”

She once said, borrowing from previous thought leaders: “This is what happens when you work to change things, and first they think you’re crazy, then they fight you and then all of a sudden you change the world.” I wonder if she just thinks she’s now on part two.

Raising money to start a company is about two things: having connections and making an appearance. Connections are difficult to make when you’re a woman: “Only about 12% of decision-makers at VC firms are women, and most firms still don’t have a single female partner.”

And even if you have connections, building relationships can be a bit weird: My cofounders end up being text buddies with our investors, while I hear news of things in passing. We hit a peak of 2.8% of funding going to women-led startups in 2019, but in 2020, that dropped again to 2.3%, possibly because investors reverted to their standard habits of keeping their cards close during uncertain times. Furthermore, investors generally have expectations that are aligned with male tendencies. For example, identical slides and scripts that are read by men and women are judged very differently, with men overwhelmingly rated higher. Holmes’ deep voice, although off-putting, probably made her more convincing.

It’s not easy to replicate the fundraising success that Holmes had, though. If other women tried to emulate this, they’d likely be penalized: In general, forward men are viewed positively as assertive, while forward women are viewed as emotionally unstable. This is confusing because, inversely, if women retreat to stereotypically feminine behaviors, they are viewed as weak. Hillary Clinton got stuck in this during her presidential race — criticized for being aggressive and cold when stereotypically masculine traits and pegged as weak when showing stereotypically feminine traits.

To make matters worse, it turns out that in pitches, women are asked more preventative questions about potential loss and risk, while men are asked more promotional questions about upside and gains. Women can work around this by answering any preventative question in the positive. Holmes knew this deep down and played into it. That was the only way for her to win.

I am absolutely no “holmie,” but I do understand firsthand her need to role-play. I’ve been overlooked; hell, I’ve even been told to change my product line (bras) because venture capitalists won’t get it. And they didn’t. I gave in.

I don’t want to defend her, and I can’t. It’s so easy to drop a line at a party or a board meeting about how obnoxious she was in her venture, but what irks me is that we focus on her specifically as the problem, completely bypassing the environment that created her. I remember soaking up John Carreyrou’s tantalizing book thinking, “Wow, I’ll never do that,” as I started my company. But as I have seen the pressures and the biases, I can see how the system shaped Holmes.

Why don’t we judge the biased system we created as much as we judge the person it destroyed? She sticks out like a sore thumb because, well, how many Elizabeth Holmeses are there out there? These problems are so ingrained in the system itself, though, that as David Foster Wallace alluded to in the water speech, we can’t see them and we probably aren’t ready to repair them.

The next time someone jokes at a cocktail party about Holmes’ baritone voice, just remind them how dumb is it that we give more money to people with deep voices.

Former TechCrunch COO Ned Desmond is now Senior Operating Partner at SOSV, which has invested in unspun.

With echoes of Theranos, Truvian Sciences revives the dream of low-cost, accessible blood tests

A little over a year after the dissolution of the once high-flying blood testing startup Theranos, another startup has raised over $27 million to breathe new life into the vision of bringing low-cost blood tests to point-of-care medical facilities.

Unlike Theranos, Truvian Sciences is not claiming that most of its blood tests do not need clearance from the U.S. Food and Drug Administration, and is, in fact, raising the money to proceed with a year-long process to refine its technology and submit it to the FDA for approval.

“More and more consumers are refusing to accept the status quo of healthcare and are saying no to expensive tests, inconvenient appointments and little to no access to their own test results,” said Jeff Hawkins, the president and chief executive of Truvian, in a statement. “In parallel, retail pharmacies are rising to fill demand, becoming affordable health access points. By bringing accurate, on-site blood testing to convenient sites, we will give consumers a more seamless experience and enable them to act on the vast medical insights that come with regular blood tests.”

Hawkins, the former vice president and general manager of reproductive and genetic health business at Illumina, is joined by a seasoned executive team of life sciences professionals including Dr. Dena Marrinucci, the former co-founder of Epic Sciences, who serves as the company’s senior vice president of corporate development and is a co-founder of the company.

Image courtesy of Flickr/Mate Marschalko

As part of today’s announcement, the company said it was adding Katherine Atkinson, a former executive at Epic Sciences and Illumina, as its new chief commercial officer, and has brought on the former chairman of the Thermo Fisher Scientific board of directors, Paul Meister, as a new director.

Funding for the company came from GreatPoint Ventures and included DNS Capital,Tao Capital Partners and previous investor Domain Associates.

The ultimate goal, according to Hawkins, is to develop a system that can be installed in labs and can provide accurate results in 20 minutes for a battery of health tests from a small sample of blood for as low as $50. Typically, these tests can cost anywhere from several hundred to several thousand dollars — depending on the testing facility, says Hawkins.

Using new automation and sensing technologies, Truvian is aiming to combine chemistries, immunoassays and hematology assays into a single device that can perform standard assessment blood tests like lipid panels, metabolic panels, blood cell counts, and tests of thyroid, kidney and liver functions.

The company’s system includes remote monitoring and serviceability, according to a statement from Truvian. Its dry reagent technology allows materials to be stored at room temperature, removing the need for cold chain or refrigerated storage. According to a statement, the company is working to receive a CE Mark in the European Economic Area and submitted to the FDA for 510(k) clearance along with a  “clinical laboratory improvement amendments” waiver application to let the devices be used in a retail setting or doctor’s office.

“We don’t believe that single drop of blood from a finger stick can do everything,” says Hawkins (in opposition to Theranos). “Fundamentally as a company we have built the company with seasoned healthcare leaders.”

As the company brings its testing technology to market, it’s also looking to compliment the diagnostics toolkit with a consumer-facing app that would provide a direct line of communication between the company and the patients receiving the results of its tests.

Truvian’s data will integrate with both Apple and Google’s health apps as well as reside on the company’s own consumer-facing app, according to Hawkins.

“At the end of the day precision medicine is going to come from integrating these data sources,” says Hawkins. “I think if we pull off what we want we should be able to make your routine blood testing far more accessible.”

Theranos founder Elizabeth Holmes to stand trial in 2020

Elizabeth Holmes, the founder of the now-defunct biotech unicorn Theranos, will face trial in federal court next summer with penalties of up to 20 years in prison and millions of dollars in fines.

Jury selection will begin July 28, 2020, according to U.S. District Judge Edward J. Davila, who announced the trial will commence in August 2020 in a San Jose federal court Friday morning.

Holmes and former Theranos president Ramesh “Sunny” Balwani were indicted by a grand jury last June with 11 criminal charges in total. Two of those charges were conspiracy to commit wire fraud (against investors, and against doctors and patients). The remaining nine are actual wire fraud, with amounts ranging from the cost of a lab test to $100 million.

According to Bloomberg, Holmes’ legal team plans to argue that The Wall Street Journal’s John Carreyrou “had an undue influence on federal regulators,” and “went beyond reporting the Theranos story.”

“The jury should be aware that an outside actor, eager to break a story, and portray the story as a work of investigative journalism, was exerting influence on the regulatory process in a way that appears to have warped the agencies’ focus on the company and possibly biased the agencies’ findings against it,” her attorneys wrote, per Bloomberg. “The agencies’ interactions with Carreyrou thus go to the heart of the government’s case.”

Theranos, founded in 2003 by then 19-year-old Stanford dropout Holmes, raised more than $700 million from private market investors in what’s been referred to by the Securities and Exchange Commission as an “elaborate, years-long fraud in which they exaggerated or made false statements about the company’s technology, business, and financial performance.”

Theranos first came under scrutiny in October 2015, when Carreyrou published his first of many investigative pieces questioning the efficacy of Theranos’ blood-testing technology. At the time, Theranos was one of the most buzzworthy companies in Silicon Valley, boasting a valuation of $9 billion and the support of high-profile investors like Tim Draper via venture capital firm Draper Fisher Jurvetson and Robert Murdoch.

Theranos, as a result of Carreyrou’s reporting, was discovered to be a threat to public health and its technology, as it turns out, was light years away from its claims to quickly process an expansive range of laboratory tests from just a few drops of blood.

According to The Wall Street Journal, federal prosecutors have collected more than 2 million pages of evidence for the defense teams. Holmes, despite ample evidence, has maintained her innocence since the grand jury indictment last year.

Holmes stepped down from Theranos last year following the criminal charges. The company finally ceased operations in September after failing to salvage anything from the wreckage. Carreyrou, for his part, released a best-selling book, ‘Bad Blood,’ documenting Theranos’s secrets and lies. A documentary chronicling Holmes’ and Theranos’ rapid rise and fall was released by HBO in 2019. A Hollywood production starring Jennifer Lawrence as Elizabeth Holmes is reportedly in the works.

Dear Hollywood: Here are five female founders to showcase instead of Elizabeth Holmes

There’s a seemingly insatiable demand for Theranos content. John Carrerou’s best-selling book, Bad Blood has already inspired an HBO documentary, The Inventor, an ABC podcast called The Dropout, a prestige limited series starring SNL’s Kate McKinnon was just announced, and Jennifer Lawrence is reportedly going to star in the feature film version of this tawdry “true crime meets tech” tale. That’s before getting started on the various and sundry cover stories and think pieces about her fraud.

I think it’s fair to say the Theranos story has been sufficiently well-documented and I’m worried that this negative perception may be reinforced now that UBiome founder Jessica Richman has been placed on administrative leave. While it’s hard to pass on a chance to stoke startup schadenfreude, perhaps we could focus less on these rare, unrepresentative, and dispiriting examples? Instead, Hollywood could put the spotlight on women who pioneered the bleeding edge of tech and actually produced billion-dollar successes. Here are a few candidates ready for their close-ups:

Judith Faulkner, founder and chief executive officer, Epic Systems

Judith Faulkner – Founder/CEO, Epic Systems

In the late 1970s, the picture of a working woman in Wisconsin was likely Laverne or Shirley. Little did anyone know that in the basement of a Victorian manse in Madison, the future of healthcare was being coded by Judith Faulkner, the founder and CEO of what would become Epic Systems. Epic is arguably the most impactful startup in the history of health software, and Faulkner was building medical scheduling software before most people could even picture a PC. Her efforts established the Electronic Medical Records market as we know it and today, her company manages records for over 200 million people, employs nearly 10,000, and generates around $2.7B per year in revenue — not bad for a math graduate who never raised any venture capital.

One might argue that the origins of medical software are too tepid to make for exciting TV, but something tells me the kind of CEO who hires Disney alums to design her corporate campus and dresses up like a wizard to address her employees might make for a compelling subject.

SANTA BARBARA, CA – FEBRUARY 09: Lynda Weinman speaks onstage (Photo by Rebecca Sapp/Getty Images for SBIFF)

Lynda Weinman – Founder/CEO, Lynda.com

Lynda Weinman might have the most esoteric path to becoming a billion-dollar entrepreneur in history. After getting a humanities degree from Evergreen College, where she was classmates with Simpsons creator Matt Groenig, Lynda opened up a pair of punk rock fashion boutiques on LA’s Sunset Strip.

After those folded in the early 1980s, she taught herself enough computer graphics to become a freelance animator on movies like Bill & Ted’s Excellent Adventure, which in turn led to her becoming a teacher at the prestigious Art Center College of Design. Her academic pedigree provided the launching pad to write an influential textbook, that in turn gave her the star power to strike out on her own as one of the first web celebrities.

Keep in mind; this dramatic arc only covers the time before she started the eponymous Lynda.com, and bootstrapped it to a $1.5B exit in EdTech — an industry most VCs and entrepreneurs fear to tread. In terms of material for a memoir, Hannah Horvath has nothing on Lynda Weinman.

 

FRAMINGHAM, MA – MAY 30: Shira Goodman, former chief executive at Staples, poses for a portrait in Framingham, MA on May 30, 2017. (Photo by Suzanne Kreiter/The Boston Globe via Getty Images)

Shira Goodman – CEO, Staples.com

Shira Goodman has arguably done more for online shopping in the US than anyone not named Bezos. She didn’t found Staples, but she did start and scale its “delivery business,” as she humbly calls it, to the point where it became the 4th largest ecommerce company in the US.

At a time when more nimble startups were disrupting big-box retailers, Shira did what few of her contemporaries could do — rapidly shifted a multi-billion dollar legacy company in an ancient industry into the future, and eventually became CEO of the entire enterprise. She did this while also raising three children and supporting her husband when he decided to change careers and go to Rabbinical school. Sitcoms have been premised on less, and since two versions of The Office have captivated audiences, perhaps it’s time to provide the perspective from the CEO of Dunder-Mifflin HQ?

Helen Greiner, co-founder, iRobot

Helen Greiner – Co-founder, iRobot

From C. A. Rotwang in Metropolis to Tony Stark in the Marvel movies, there have been plenty of cinematic explorations of robot builders, but the story of iRobot co-founder Helen Greiner might be more interesting than anything yet committed to celluloid. As a recent grad from MIT, Greiner spent a substantial chunk of the 1990s applying her mechanical genius to everything from a mechatronic dinosaur for Disney to a store cleaning robot with the potential for mass destruction for SC Johnson.

Far from an ivory tower academic, Grenier helped the government deploy search and rescue efforts at Ground Zero after 9/11, cave-clearing ‘bots in Afghanistan, and the bomb-disposing Packbot she developed has saved the lives of thousands of service members. Grenier, at age 38, took her company public and made the Jetson’s vision of a robot housekeeper a reality in the form of the Roomba.

CAMBRIDGE, MA – MARCH 15: Kelsey Wirth, who has a grassroots organization called Mothers Out Front: Mobilizing For A Livable Climate (Photo by Essdras M Suarez/The Boston Globe via Getty Images)

Kelsey Wirth – Co-founder, Align Technologies

While the original startup bros were inflating the tech bubble in the late 1990s, Kelsey Wirth was pioneering 3-D printing, which at the time was as fantastical as anything Theranos promised. Wirth’s story as the co-founder of Align Technology is especially compelling in the way it shares some surface similarities with Holmes’ narrative. Prominent skeptics of Invisalign cast doubts on the company in its early days, noting that the startup’s PR had outstripped its clinical validation. Wirth had to solve seemingly intractable technical challenges including scanning misaligned incisors, developing algorithms to overcome underbites, pioneering new manufacturing process, convincing the FDA to clear the product, and then selling it across the country — armed only with an English lit degree and an MBA. Despite the long odds of curing crossbites with software, Wirth started what has become a publicly-traded business that is currently worth over 20 billion dollars.


Most of these founders faced setbacks, including external obstacles and those of their own making. There were layoffs, bad deals, and few of these stories had perfectly happy endings. Still, while a contemporary startup can earn plaudits for simply repackaging CBD and pushing it on Facebook, these entrepreneurs demonstrated a level of ambition rarely seen among modern upstarts.

The sensational focus on Elizabeth Holmes’ misdeeds steal focus from a group of landmark female entrepreneurs and waste a tremendous opportunity to inspire the next generation with heroic tales instead of fables of fabrication. None of these accounts have the black and white morality of the Theranos debacle, but these founders cleared hurdles both scientific and social. They flipped the script and made history, surely Hollywood can find some drama in that.

Thanks to Parul Singh, Elizabeth Condon, and Alyssa Rosenzweig for reviewing drafts of this post.

Hulu orders Theranos miniseries starring Kate McKinnon as Elizabeth Holmes

Silicon Valley may have dealt with some rough hubris throughout the saga of Theranos, but Hollywood is basking in its downfall.

Weeks after the premiere of an HBO documentary chronicling Elizabeth Holmes’s grand blood-testing charade and in the midst of development of a film starring Jennifer Lawrence, Hulu has ordered its own Theranos limited series starring Kate McKinnon based on ABC Radio’s hit podcast series on Theranos, The Dropout.

The podcast, which debuted in January, followed the rise and fall of Stanford dropout Elizabeth Holmes’ Theranos, which raised roughly $900 million in venture capital before reality caught up with its unbelievable claims and the company dissolved into chaos and criminal charges.

With SNL mainstay Kate McKinnon donning the black turtleneck, one can only wonder what demeanor she will bring the easily-parodied Holmes character. McKinnon recently co-starred in Ghostbusters and has been a cast member on Saturday Night Live since 2012.

The series is expected to be 6-10 episodes, according to Deadline. The podcast’s producers Taylor Dunn and Victoria Thompson will be producers on the miniseries.

Original Content podcast: ‘The Inventor’ offers a compelling overview of the Theranos saga

The story of how blood testing company Theranos rose to prominence, then collapsed following accusations of fraud, is getting told and retold in many forms: There’s reporter John Carreyrou’s book “Bad Blood,” plus an upcoming feature film adaptation starring Jennifer Lawrence, plus a podcast from Nightline called “The Dropout” — and “The Inventor,” a new HBO documentary directed by Alex Gibney.

Our colleague Josh Constine already reviewed the film after seeing it at Sundance, but we had thoughts of our own, which we hashed out with guest host Anna Escher on the latest episode of the Original Content podcast.

Gibney previously spoke to TechCrunch about his Steve Jobs documentary “The Man in the Machine,” arguing that a documentary has more to offer than just “a list of facts.”

Similarly, viewers who’ve read “Bad Blood” or followed the Theranos story closely may not discover many new facts in “The Inventor.” But even so, the film is worth watching for its clear distillation of what happened, and for its copious behind-the-scenes footage of Holmes (who ends up feeling like a major presence even though she wasn’t interviewed).

There are also some parallels to “Fyre,” the recent Netflix documentary about the Fyre Festival —particularly the focus on employees who get caught up in an entrepreneur’s grand vision, even when they knew their bosses were playing fast-and-loose with the facts.

And we also share our thoughts on the third season of “Queer Eye,” both its political message and our favorite cast member (Bobby forever!).

You can listen in the player below, subscribe using Apple Podcasts or find us in your podcast player of choice. If you like the show, please let us know by leaving a review on Apple. You can also send us feedback directly. (Or suggest shows and movies for us to review!)

Here’s a sneak peek at HBO’s Elizabeth Holmes documentary, The Inventor

The story of Elizabeth Holmes and Theranos has inspired quite a bit of content, including a NYT Best Seller, an ABC podcast, a movie starring Jennifer Lawrence, and now an HBO documentary directed by Going Clear director, Alex Gibney.

The documentary is called The Inventor: Out For Blood In Silicon Valley.

The tech world was shocked when the WSJ broke the news that Theranos, the biotech startup founded by Elizabeth Holmes, wasn’t what it appeared to be.

Promising to revolutionize healthcare, Theranos wanted to accomplish the impossible by creating a device that could significantly speed up the time it takes to test blood and diagnose disease. This, it turns out, was actually impossible.

Elizabeth Holmes, the world’s youngest self-made female billionaire, was at the helm of the Theranos fantasy, which ballooned to a $9 billion valuation before being identified as a fraud by the SEC.

HBO documentary The Inventor: Out For Blood In Silicon Valley debuts on Monday, March 18, and catalogs the story through interviews with the reporters who documented it, whistleblowers, former Theranos employees and experts.

This includes John Carreyrou, author of “Bad Blood”; journalists Ken Auletta (The New Yorker) and Roger Parloff (Forbes), who wrote profiles of Holmes; Theranos whistleblowers Tyler Shultz and Erika Cheung; former Theranos employees Dave Philippides, Douglas Matje, Ryan Wistort and Tony Nugent; behavioral economist Dan Ariely; and Dr. Phyllis Gardner, MD, professor of medicine at Stanford University.

TechCrunch’s Josh Constine reviewed The Inventor after its Sundance premiere.

The documentary will be available on HBO, HBO NOW, HBO GO, HBO On Demand and partners’ streaming platforms.

[Video courtesy of HBO]

Lack of transparency in healthcare startups risks another Theranos implosion

Are more Theranos -style scandals looming for investors in healthcare startups?

A team of researchers associated with the Meta Research Innovation Center at Stanford thinks so. They’ve  published a paper warning investors in life sciences startups that a systemic lack of transparency exists in their portfolio companies — creating the possibility for more multi-billion dollar implosions and scandals like the one that toppled Theranos and its charismatic founder, Elizabeth Holmes.

Indeed, one of the study’s authors, Dr. John Ioannidis, the co-director of the Meta-Research Innovation Center at Stanford and director of the University’s PhD program in Epidemiology and Clinical Research, was  among the first people to identify the risks associated with Theranos and its “stealth research”.

Now Dr. Ioannidis and his co-authors, Ioana A. Cristea and Eli M. Cahan have published a study surveying the publicly available research from the largest privately held companies in the healthcare space, and found them lacking. 

Most of the highest valued startups in healthcare have not published any significant scientific literature, the study found. Nearly half of the publications from companies worth over $1 billion came from only two startups — 23andMe and Adaptive Biotechnologies, according to the paper.

“Many years ago I was the first person to say that Theranos had a problem,” says Ioannidis. “The problem that I had then was that Theranos did not have any peer-reviewed evidence to show.”

In an interview and in their paper, Ioannidis and Cahan warn that investors have overlooked systemic problems created by the lack of transparency among healthcare startups by

They write:

“It would be tempting to dismiss the Theranos case as just one rotten apple. However, we worry that the focus on fraud puts aside a more fundamental concern. Fraud is making waves in the news, but stealth research may have a more detrimental impact.”

According to the study’s findings, more than half of the healthcare startups that are worth more than $1 billion have published no highly cited papers at all. For companies that were acquired or are publicly traded that number is around 40%.

In all, healthcare startups that are currently valued at over $1 billion published 425 Pubmed papers. And of those papers only 34 (8%, including 2 reviews) were highly cited. For companies with valuations of over $1 billion who had been acquired or are publicly traded on stock exchanges, the researchers counted 413 papers, of which 47 (11%, including 9 reviews) were highly-cited.

Digging deeper into some of the companies which had high valuations but little or no published research revealed scores of operational and technological issues for the researchers.

For instance, StemCentrx, which was bought for $10.2 billion in 2016 by AbbVie, had published 16 papers — and only one highly-cited paper. Since the acquisition, the Food and Drug Administration had imposed a delay on the readout of the company’s phase II trial for its Rova T targeted antibody drug for cancer treatment. In December a Phase III trial for Rova T as a second-line treatment for patients with advanced small cell lung cancer was halted, because the treatment wasn’t working, according to a report in Targeted Oncology

Acerta Pharma, another healthcare focused startup focused on cancer treatments was bought by AstraZeneca for $7.3 billion. That company published nine articles and had one highly-cited paper for a very early study of a potential treatment for relapsed chronic lymphocytic leukemia. Acerta received accelerated approval for a drug called acalabrutinib, which treats a rare form of lymphoma called mantle cell lymphoma. Two years ago, AstraZeneca had to retract data and admit that Acerta falsified preclinical data for its drug.

Then there’s Intarcia, the developer of a device for diabetes treatment that’s worth $5.5 billion. That company had its device rejected by the FDA and was forced to lay off staff and halt a couple of later stage trials. It had only published six papers — none of them very highly cited.

Ultimately, the researchers concluded that highly valued healthcare startups don’t contribute to published research and that the valuation of these companies by investors is divorced from any externally validated data.

For the researchers (and for investors) this should presents a problem.

“Many unicorns may be overvalued [21] and subject to unrealistic scientific expectations,” the study’s authors write. And they reject the argument that simply applying for — and receiving — patents is enough to prove that a technology in the healthcare space has been thoroughly vetted. “[Patents] do not offer the same level of documentation as peer-reviewed articles. For example, Theranos had over 100 patents [1], but these were unable to supplant the vacuum in their evidence,” the researchers wrote. 

Even if companies want to protect their technology, there are still ways for them to be more transparent about the results or benefits of their technology. The authors acknowledge that publishing isn’t the primary mission of startups. They can, however publish a few high-value articles, secure their technology through patents and then work with researchers, universities or hospitals to validate the technology and have those organizations publish results of the tests, the authors argue.

As the authors conclude:

Start-ups are key purveyors of innovation and disruption. Consequently, holding them to a minimal standard of evaluation from the scientific community is crucial. Participation in peer review, with all its limitations, is the best way we have to uphold this standard. We are not arguing that start-ups should divert excessive resources to having peer-reviewed papers. However, when their products are destined to affect patient health, they should neither be solely doing marketing. Confidential data sharing with potential investors or regulators cannot replace more open scrutiny by the scientific community.

 

Theranos documentary review: The Inventor’s horrifying optimism

A blood-splattered Theranos machine nearly pricks an employee struggling to fix it. This gruesome graphical rendering is what you’ll walk away from HBO’s “The Inventor” with. It finally gives a visual to the startup’s laboratory fraud detailed in words by John Carreyrou’s book “Bad Blood”.

The documentary that premiered tonight at Sundance Film Festival explores how the move fast and break things ethos of Silicon Valley is “really dangerous when people’s lives are in the balance” as former employee and whistleblower Tyler Shultz says in the film. Theranos promised a medical testing device that made a single drop of blood from your finger more precise than a painful old-school syringe in your vein. What patients ended up using was so inaccurate it put their health in jeopardy.

But perhaps even more frightening is the willingness of Theranos CEO Elizabeth Holmes to delude herself and everyone around her in service of a seemingly benevolent mission. The documentary captures how good ideas can make people do bad things.

“The Inventor: Out For Blood In Silicon Valley” juxtaposes truthful interviews with the employees who eventually rebelled against Holmes with footage and media appearances of her blatantly lying to the world. It manages to stick to the emotion of the story rather than getting lost in the scientific discrepancies of Theranos’ deception.

The film opens and closes with close-ups of Holmes, demonstrating how the facts change her same gleaming smile and big blue eyes from the face of innovative potential to that of a sociopathic criminal. “I don’t have many secrets” she tells the camera at the start.

Though the film mentions early that her $9 billion-plus valuation company would wind up worth less than zero, it does a keen job of building empathy for her that it can tear down later. You see her tell sob stories of death in the family and repeat her line about building an end to having to say goodbye to loved ones too soon. You hear how she’s terrified of needles and how growing up, “my best friends were books.”

But then cracks start to emerge as old powerful men from professors to former cabinet members faun over Holmes and become enthralled in her cult of personality as validation snowballs. Oscar-winning director Alex Gibney has a knack for creeping dread from his experience making “Enron: The Smartest Guys In The Room” and “Going Clear: Scientology and the Prison of Belief.” He portrays Holmes’ delusions of grandeur with shots of her portrait beside those of Archimedes, Beethoven, and her idol Steve Jobs.

The first red flag comes when Holmes names her initial device Edison after the historic inventor the film assures you was quite a fraud himself. Soon, sources from inside the company relay how the Edison and subsequent Theranos hardware never worked right but that demos were faked for customers and investors. Instead of sticking to a firm timeline, Gibney bounces around to hammer home the emotional arcs of employees from excited to dubious, and of Holmes from confidence to paranoia.

Carreyrou’s “Bad Blood” meticulously chronicled every tiny warning sign that worried Theranos’ staff in order to build a case. But the author’s Wall Street Journal day job bled through, sapping the book of emotion and preventing it from seizing the grandeur of the tale’s climactic moments.

Gibney fills in the blanks with cringe-inducing scenes of Theranos’ faulty hardware. A ‘nanotainer’ of blood rolls off a table and fractures, a biohazard awaiting whoever tries to pick it up. The depiction of working in Theranos’ unregulated laboratory scored the biggest gasps from the Sundance audience. Former employees describe how Theranos recruited drifters they suspected of hepatitis as guinea pigs. Their stale blood evaporates into the air surrounding machines dripping with inky red, covered in broken test tubes. Gibney nails the graphics, zooming in on a needle spraying droplets as a robotic arm sputters through malfunctions. I almost had to look away as the film renders a hand reaching into the machine and only just dodging an erratic syringe.

A still from The Inventor: Out For Blood in Silicon Valley by Alex Gibney, an official selection of the Documentary Premieres program at the 2019 Sundance Film Festival. Courtesy of Sundance Institute | photo by Drew Kelly.

At times, Gibney goes a bit too melodramatic. The toy music box twinkling foreshadows a dream becoming a nightmare, but it gets maddening after an hour straight. The pacing feels uneven, sometimes bogged down in Holmes’ personal relationships when later it seems to speed through the company’s collapse.

Though elsewhere, the director harnesses the nervous laughter coping mechanism of the former employees to inject humor into the grim tale. With accuracy so low, Shultz jokes that “if people are testing themselves for syphilis with Theranos, there’s going to be a lot more syphilis in the world.” Visual dramatizations of journalists’ audio recordings of Holmes and the eventual legal disputes bring this evidence to life.

Alex Gibney, director of The Inventor: Out For Blood in Silicon Valley, an official selection of the Documentary Premieres program at the 2019 Sundance Film Festival. Courtesy of Sundance Institute.

The most touching scene sees Fortune’s Roger Parloff on the brink of implosion as he grapples with giving Holmes her first magazine cover story — momentum she used to eventually get Theranos’ useless hardware in front of real patients who depended on its results.

The Inventor succeeds at instilling the lesson without getting too preachy. It’s fine to be hopeful, but don’t ignore your concerns no matter how much you want something to be real. It takes an incredibly complex sequence of events and makes it at once gripping and informative. If you haven’t read “Bad Blood” or found it drab, “The Inventor” conveys the gravity of the debacle with a little more flare.

Yet the documentary also gives Holmes a bit too much benefit of the doubt, suggesting that hey, at least she was trying to do good in the world. In the after-film panel, Gibney said “She had a noble vision . . . I think that was part of why she was able to convince so many people and convince herself that what she was doing was great, which allowed her to lie so effectively.” Carreyrou followed up that “she was not intending to perpetrate a long con.”

Yet that’s easier to say for both the director and the author when neither of their works truly investigated the downstream health impacts of Theranos’ false positives and false negatives. If they’d tracked down people who delayed critical treatment or had their lives upended by the fear of a disease they didn’t have, I doubt Holmes would be cut so much slack.

Some degree of ‘Fake it ’til you make it’ might be essential to build hard technology startups. You must make people believe Inc something that doesn’t exist if you’re to pull in the funding and talent necessary to make it a reality. But it’s not just medical, hardware, or “atoms not bits” startups that must be allegiant to the truth. As Facebook and WhatsApps’ role in spreading misinformation that led to mob killings in India and Myanmar proved, having a grand mission doesn’t make you incapable of doing harm. A line must be drawn between optimism and dishonesty before it leads to drawing chalk outlines on the ground.