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Silicon Valley Will See You Now

Andrew Leonard | December 22, 2015 | Story News and Features National

Sam De Brouwer hands me a sleek device about the size and shape of a makeup compact. Called the Scanadu Scout, it is designed to measure blood pressure, body temperature, heart and respiratory rates, and blood oxygen and emotional stress levels with no muss or fuss. She demonstrates how to hold it gently against the left side of my forehead. A moment later, my blood pressure reading, pleasantly healthy, pops up on De Brouwer’s iPhone. It seems a little bit like magic.

De Brouwer claims that the Scout is modeled on Star Trek’s beloved medical tricorder—the smartphone-size device that Dr. “Bones” McCoy employed to instantly assess a patient’s health. But she sees the device as much more than a cute gimmick: To her, it’s an early step in a revolution that will put people in charge of their own healthcare by giving them real-time, 24-7, user-friendly health data. Forget about the headaches of getting a doctor’s appointment, waiting on a testing lab’s results, or even figuring out what your health insurance will cover. De Brouwer believes that’s all about to change. “We are entitled to our own empowerment,” she proclaims.

Because this is Silicon Valley, where each new twist of the business cycle comes laden with not only glowing accounts of new products and services but also world-changing rhetoric and ideological calls to arms, promoters of digital health like De Brouwer are promising more than just lower medical bills. They gush that an explosion of “citizen science” is going to bring about the “democratization of healthcare” and outright “medical emancipation.”

Few deny that America’s deeply flawed healthcare system could use emancipation. It’s too expensive, too inefficient, too complex. And there’s also no denying that the current technological moment bursts with potential. We’re in the middle of what Lisa Suennen, an experienced healthcare venture capitalist, calls a “harmonic convergence” of legislative change, spiraling healthcare costs, and rapid technological advance. Our ability to sequence our own genetic code—a fantasy just a few decades ago, a cheap commodity today—offers vast new potential for understanding and curing disease. The proliferation of the smartphone and the plummeting cost and skyrocketing capability of sensor technology means that health data formerly available only to doctors or researchers is now accessible to millions. The startups that are aiming to disrupt our healthcare system have powerful tools at their disposal.

“This has got legs,” says cardiologist Eric Topol, director of the Scripps Translational Science Institute and author of The Patient Will See You Now: The Future of Medicine Is in Your Hands, a book touting the digital-health revolution. “We’re on an irrevocable path. It’s going to happen. It’s just a matter of when.”

But this irrevocable path is running headlong into a vortex that has long swallowed many of humanity’s greatest minds: how to identify and fight disease. Not surprisingly, many doctors are wary of a future in which the general public eschews consulting medical professionals in favor of self-diagnosing with the help of a device like the Scanadu Scout. Mistakes, they are sure, will be made—and mistakes involving health are no joke.

Yet even the skeptics acknowledge that the sheer volume of data generated by the digital health revolution will ultimately be beneficial. A little knowledge, for a self-diagnosing patient, is a dangerous thing. A lot of knowledge, acquired from thousands of self-monitoring individuals, could revolutionize science. And, at a deeper level, just as technology has ushered in undreamed-of advances in communications and manufacturing, so it will undoubtedly improve medicine. The patient is Silicon Valley’s newest consumer market. The only question is whether the industry’s medicine will be worse than the disease.

Sam de Brouwer can tell you exactly when she found her cause. Ten years ago, her five-year-old son, imagining that he could fly, jumped out of the third-story window of her home in Belgium. “He spent three months in a coma, a year in the hospital,” says De Brouwer. “His brain was damaged—he couldn’t speak, couldn’t walk, couldn’t see, couldn’t swallow.”

In the weeks and months that followed the injury, Sam and her husband, Walter, struggled with hospital bureaucracy, doctors who couldn’t answer their questions, and the bewildering medical mysteries of a severely injured cerebral cortex. They felt at the mercy of forces they simply didn’t understand. “I remember Walter telling me,” recalls De Brouwer, “‘You know what, we have to understand his environment or he will not survive.’ It was the trigger of everything we do today and everything we are today.”

For 20 years, Sam and Walter have been serial entrepreneurs, forming companies that sought a sweet spot right in front of the Internet’s breaking wave. Neither has a medical background, but in the wake of this family catastrophe they saw an opportunity to leverage their technology and business know-how in support of patients who, like them, were overwhelmed by the medical-industrial complex.

Tackling the problem of brain trauma directly, they decided, was too big a challenge. But addressing patient powerlessness wasn’t. The De Brouwers moved from Belgium to Mountain View, landed investments from a couple of massive Chinese tech companies, and got to work.

The underlying philosophy behind the Scanadu Scout is simple: Measurement affects behavior. If you have easy access to your vital signs, it should be easier for you to change your behavior and live more healthily. A once-a-year physical where you get a few minutes with an overworked physician is no substitute, so the theory goes, for a year-round flow of information.

“When you observe, you modify,” says De Brouwer. “Access to and ownership of our own data,” she declares, are the first steps in becoming what she calls citizen doctors. She is convinced that her decision to devote herself full-time to understanding the ramifications of her son’s care made all the difference.

De Brouwer’s son is now a teenager. He is paralyzed on one side, but his mother's face glows when she talks of how he is learning English and beginning, finally, to walk and read. The likelihood that he would ever be able to do anything cognitive at all was extremely faint, she recalls, according to the doctors with whom she talked in the immediate aftermath of the accident.

“If I had not become a citizen doctor,” De Brouwer says, “if I had not become the project manager for my own son at the hospital, if I had not understood all those machines that I was monitoring myself—because the nurses were not there 24-7…. I am not a scientist and I am not a doctor, but if I had not done all those things, my son would not be alive today.”

Silicon Valley is driven by two things: an invincible belief in technological progress and a capitalist killer instinct. That’s why digital-health entrepreneurs are challenging the healthcare industry, says Robert Wachter, the chief hospitalist at the University of California San Francisco. “Silicon Valley is not stupid,” he says. “They’ve looked at healthcare and said, ‘Healthcare is 18 percent of the GDP, and it’s the only portion of the economy that is that big that’s completely analog.’ A normal American sees how technology has transformed the rest of his life and says, ‘Wow, I can’t wait for this to come to healthcare. It is going to make stuff better, cheaper, faster.’”

Wachter is the author of The Digital Doctor: Hope, Hype, and Harm at the Dawn of Medicine’s Computer Age, a book that is as cautious about the digital-health “revolution” as Topol’s The Patient Will See You Now is exuberant. Wachter has spent a lifetime studying how mistakes happen in medical care, and if he is sure of one thing, it’s that the digital transformation of healthcare is not going to happen smoothly. Just getting hospitals and clinics to digitize their patient records—a process goosed by $19 billion from the Obama administration in the form of 2009’s HITECH Act—has been a major headache, says Wachter. He believes that some of the wilder (and most enticing) fantasies of the digital-health movement—such as the notion that we’ll use our smartphones to generate health data that will be uploaded to the cloud and analyzed by artificially intelligent algorithms capable of diagnosing us—are sheer “hogwash.”

“That idea doesn’t take into account the interdependencies and complexities of medicine,” says Wachter. “You’re not just trying to figure out if customers who bought this book also bought that book. It’s deeper, it’s more complex, it’s human. There is a reason that Eric Topol and I went to school and did our residencies for 10 years.”

Wachter worries that patients who look outside of the medical profession for advice will make bad decisions. He is also alarmed by the fact that the skyrocketing cost of health insurance is having the effect of encouraging patients to avoid trained professionals. A decade ago, Wachter notes, only 10 percent of patients had insurance deductibles of $1,000 or more. “Today the number is around 50 percent. So now you have a tremendous incentive to play doctor,” he says. “You can Google your symptoms, and you can look them up on WebMD. And I get that, and I probably would do it myself. But at some point, you are going to make a bad call.”

Digital-health promoters don’t deny that, but they’re taking a longer view. And one of their articles of faith is that by tapping into large and focused databases, tomorrow’s citizen doctors will be able to make far more informed decisions than someone who just Googles her symptoms.

“I’m attracted to broken systems,” says Jessica Richman as she walks through the lab in uBiome’s South of Market offices, pointing out, with a true geek’s glee, a hardware jungle of genetic-sequencing machines and 3-D printers and robots. “And there is just so much wrong with healthcare—how you pay for it, how you deliver it, who does it, who gets it, who doesn’t get it. There’s just something wrong with everything.”

To help fix this broken system, Richman plans to merge two powerful forces: genetic-sequencing technology and the crowdsourced energy of what she happily calls “citizen science.” Her company’s mission is to unlock the mysteries of the human microbiome. Our genome contains the code that is us: our DNA. Our microbiome adds in all the other critters that hitch a ride with us as we go through life, a bewildering zoo of microbes whose functions are not yet well understood. Our digestive tract alone is estimated to be home to as many as 1,000 species of gut bacteria.

For $89, which includes the cost of a home-testing kit, uBiome will sequence a sample taken from your gut (for $399, you can purchase a five-test kit that also samples your mouth, nose, genitals, and skin) and tell you exactly what bacteria it finds in there. If you continue to take samples over a period of time, uBiome can show you how your bacteria population changes depending on changes in your diet or physical activity or medication. You might learn, for example, that the course of antibiotics you took to cure your strep throat completely hammered your gut bacteria diversity. (Which is not a good thing. We don’t know much about the microbiome, but we do know that gut diversity is a positive.)

UBiome wants to do what biomedical researchers call translational medicine: take scientific findings and turn them into useful diagnostic tools or therapies. “Our goal is to build up a data set of microbiome code and then to commercialize the value from that data set,” says Richman. She is attacking an obvious market niche: The business of laboratory testing (all those blood tests that your doctor orders) is worth $75 billion annually in the United States and is predominantly controlled by just two companies. If uBiome can parlay its microbiome data into competitive diagnostic tools, voilĂ ! Healthcare industry disruption and insane profits.

In October, uBiome announced an iPhone app designed to work with Apple’s ResearchKit for a study on how changes in the gut microbiome correlate with weight. The first thousand people to sign up would get free sampling kits. The offer was exhausted in just four days. The stampede to sign up for sampling kits, says Richman, is proof of the power of citizen science. She hopes that by tapping into the general public’s desire to obtain a more detailed understanding of its own microbiome, collaborating with academic or corporate researchers, and capitalizing on uBiome’s own in-house expertise, her company can accelerate the process of developing marketable products and services. UBiome already has microbiome samples from 50,000 people in its database, she says.

Richman’s startup spotlights a less controversial aspect of the digital-health revolution: its potential as a research tool. The citizen scientist may not know what the data about the bacteria in her gut mean, but as a research subject, she becomes an important player in the overall project of fixing healthcare.

Linda Avey, like Richman, is trying to tap the power of the crowd, but in a more immediate, patient-useful way. When Avey cofounded the direct-to-consumer genetic-scanning company 23andMe a decade ago, she helped establish a core tenet of citizen science: the idea that people should have the right to their own data, including data about their DNA. But the larger issue—what do we do with those data?—remained unsolved. Avey’s new startup, We Are Curious, is designed to fix that problem.

Avey visualizes We Are Curious as a one-stop-shop “personal data recorder.” “People can bring in their wearable data, their genetic data, their blood test results, whatever they think might be relevant,” she says. The startup’s key innovation is that users can then get advice about their health from people who have not only similar health issues, but also similar data.

As Avey made the rounds of venture capitalist offices to drum up funds for her new venture, she was convinced that she had discovered a demographic milestone that no VC could afford to ignore: menopause. Her pitch went like this: A hypothetical middle-aged woman starts experiencing hot flashes. A Google search results in an avalanche of conflicting information. A doctor’s appointment is a pain to schedule, and her copays are high enough to make her think twice about going to the clinic. But if she is a We Are Curious user, regularly updating the site with data on her weight and sleep patterns (and, one imagines, her blood pressure readings from Scanadu and her microbiome bacteria distribution data from uBiome), she can look for advice from women who have the same data parameters, women who can tell her, “This worked for me.” Ideally, some of that advice would be helpful.

Avey didn’t pick menopause as her opening gambit by accident. Venture capitalists are supposed to be laser-focused on funding startups that are applying themselves to big but underserved markets. Avey’s research suggests that there are 45 million menopausal women in the United States. “It is one of the biggest markets in the world,” she says, “and it’s a huge problem that’s been poorly addressed by the medical community.” But time after time, the VCs just weren’t interested. “It was so shortsighted,” says Avey. “It makes you question the whole VC model. It just doesn’t make sense from a business perspective.”

Are men not taking the problem of menopause seriously because it doesn’t affect them? Is it because, as venture capitalist Suennen tartly remarked, menopause is “not something their second wives have experienced yet”? (And, according to Suennen, data suggest that woman-run companies have a hard time getting funding from a VC community that is overwhelmingly male.) Or did their lukewarm response stem from legitimate questions about Avey’s whole concept? There’s no guarantee that We Are Curious would attract a large enough user base to be viable or that its crowdsourced advice would be effective.

Whatever the reason, Avey hasn’t given up. Today she’s more likely to use chronic fatigue syndrome as an opening pitch than menopause, but she says that she’s also figured out how to turn the experience into a positive. She wants investors who “get” her vision. If they can’t see that there is a market in the health complaints of middle-aged women, she feels, she’s probably better off without their money. “That’s actually become our barometer,” she says. “We drop the menopause bomb and see how they respond.”

It’s hard not to be excited by the potential power of ventures like Scanadu, uBiome, and We Are Curious. But a healthy dose of skepticism is also in order, not least because of the difficulties faced by the two most-celebrated digital-health startups, 23andMe and Theranos.

Richman told me that she wanted uBiome to be “the 23andMe of the microbiome.” It was an interesting assertion. It made sense from an investment perspective: 23andMe has raised $241 million to date and is valued at $1.1 billion (although it has been in existence for a decade and still hasn’t turned a profit). But from a scientific perspective, it was a lot murkier.

In 2013, the FDA banned 23andMe from marketing its Personal Genome Service. The FDA, which had yet to fully sign off on the technology, was concerned “about the public health consequences of inaccurate results from the PGS devices.” The lesson for the rest of the digital-health industry was clear: Unless they’re expressly permitted by the FDA, companies should not encourage consumers to make medical decisions based on the health data the companies provide. So, even as Richman told me of her 23andMe aspirations, she cautioned that customers of uBiome are instructed not to make medical self-diagnoses using its data.

Not coincidentally, the user manual for the Scanadu Scout comes with a similar warning label. The Scout is to be considered strictly an “investigative” device: “It is not intended for diagnostic purposes.” This caveat highlights a central contradiction of the digital-health and citizen-science movement. Whether or not a majority of the general public craves its own data as much as the nerdiest Bay Area quantified selfer, growing out-of-pocket healthcare costs are pushing consumers toward market solutions that are not yet fully sanctioned by federal regulators or the medical establishment. The companies that operate in this space are eager to provide consumers with their own health data. But even as they hand over those microbiome scans and blood pressure readings, they’re forced to avoid making any direct health claims or inferences from those data—and they say that you shouldn’t either. (Although, of course, they know we all will.)

UCSF’s Wachter believes that cautioning against amateur self-diagnosis is a good thing. “I think that there certainly are people out there who want this data, could probably use it today for their own benefit, and for whom having it available is an unmitigated good,” he says, “but they are in a decided minority. For most people, giving them more and more data without context is overwhelming and can be confusing.” Topol, not surprisingly, takes an opposing view. “We don’t give people enough credit,” he says. “Humans are grossly underrated for their ability to interpret their own data. The vast majority will have a very good comprehension of what’s going on.”

Whether people will know how to interpret scientific data about their bodies will probably depend on how complex those data are (a blood sugar test is easy; a biome one may not be), what they are trying to learn, and a host of other factors. But what if the data they're getting are questionable?

“We believe that access to accurate, affordable, real-time health information is a basic human right.” These stirring words were contained in the marketing materials distributed at a Theranos clinic in a downtown Palo Alto Walgreens last September. Unfortunately for the blood-testing startup, some serious questions have arisen as to whether its information is actually accurate.

Founded in 2003 by a 19-year-old Stanford dropout named Elizabeth Holmes, Theranos came out of the gate with an unprecedented bang. On the basis of a mysterious proprietary technology—which the company claimed allowed it to conduct over 200 laboratory tests at a fraction of their cost to competitors while using far less blood for samples—it attracted $400 million in investment, a market capitalization of $9 billion, and a bizarre board of directors studded with military-industrial-complex dinosaurs, including two former secretaries of state (Henry Kissinger and George Shultz), a former secretary of defense, and two former senators. Its chief executive officer, Holmes, became the youngest self-made female billionaire in the United States.

In the marketing materials handed out at Walgreens, Theranos promised that, in contrast to its competitors, it was completely open and “transparent.” “The price you see is what you pay. You no longer have to wait for your bill to know how much your tests cost because you’ll know before you have them done. It’s testing that’s for everyone. And we mean everyone.”

Then, in mid-October, an earthquake hit that rocked not just Theranos but the entire digital-health community. The Wall Street Journal published a blockbuster exposé claiming that Theranos had not been able to get its secret technology to work consistently, that it was using conventional technology for a vast majority of its tests, and that only one of the 200-plus tests that it advertised on its website had received FDA approval.

Theranos dismissed the Wall Street Journal’s bombshell as “defamatory” and “misleading” and claimed that it was working with regulators and leading scientific and medical institutions to get all its tests properly certified. But the damage had been done. Even Topol admitted that it was “ironic” that a company that boasted about the transparency of its pricing displayed such “a lack of transparency about its data.” In a tone that didn’t quite match the exuberant boosterism of his book, he told me, “We have to be skeptical of all digital-health and digital-medical companies until they have published high-quality results in peer-reviewed literature.”

Wachter, on the other hand, is reassured by the incident. For him, the Theranos debacle proves that the FDA and other regulators will not allow Silicon Valley companies to bypass regulatory scrutiny if they are making claims about benefits but have no data to back them up. “There is so much hype in the Silicon Valley–meets–healthcare story,” he says. “The overarching message—not just from Theranos but from other companies struggling to get a toehold—is that, ultimately, the laws of economic gravity hold. The companies will have to produce products that add real value, either to patients or to payers. If they don’t, the market—or the regulators—won’t treat them kindly.”

Then again, there’s the classically Silicon Valley way to look at it. Asked what the Theranos controversy signifies for digital health purveyors at large, Avey is unfazed. “If you’re not hitting any regulatory walls,” she says, “you’re probably not doing something important.”

Originally published in the January issue of San Francisco

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