INTRODUCTION

In the mid-twentieth century Joseph Schumpeter, the noted Austrian economist, popularized the term “creative destruction” to denote transformation that accompanies radical innovation. In recent years, our world has been “Schumpetered.” By virtue of the intensive infiltration of digital devices into our daily lives, we have radically altered how we communicate with one another and with our entire social network at once. We can rapidly turn to our prosthetic brain, the search engine, at any moment to find information or compensate for a senior moment. Everywhere we go we take pictures and videos with our cell phone, the one precious object that never leaves our side. Can we even remember the old days of getting film developed? No longer is there such a thing as a record album that we buy as a whole—instead we just pick the song or songs we want and download them anytime and anywhere. Forget about going to a video store to rent a movie and finding out it is not in stock. Just download it at home and watch it on television, a computer monitor, a tablet, or even your phone. If we’re not interested in getting a newspaper delivered and accumulating enormous loads of paper to recycle, or having our hands smudged by newsprint, we can simply click to pick the stories that interest us. Even clicking is starting to get old, since we can just tap a tablet or cell phone in virtual silence. The Web lets us sample nearly all books in print without even making a purchase and efficiently download the whole book in a flash. We have both a digital, virtual identity and a real one. This profile just scratches the surface of the way our lives have been radically transformed through digital innovation. Radically transformed. Creatively destroyed.

Some will argue the predigital era was a better and simpler one. We were not connected and distracted all the time—even when driving a car. We wrote handwritten notes to one another and communicated much more deeply and effectively, albeit less frequently. We spoke on the phone to each other and did not rely on texting and instant responses. We had much more privacy, and there was no digital, immutable archive of our lives for everyone to peer at via a few clicks. We used maps to find our way from place to place instead of global positioning systems. But those days are truly past tense, and our world has irrevocably changed. The cumulative effect of extraordinary innovation that exploits digital information has turned our world upside down. Essentially, there is no turning back.

But the most precious part of our existence—our health—has thus far been largely unaffected, insulated, and almost compartmentalized from this digital revolution. How could this be? Medicine is remarkably conservative to the point of being properly characterized as sclerotic, even ossified. Beyond the reluctance and resistance of physicians to change, the life science industry (companies that develop and commercialize drugs, devices, or diagnostic tests) and government regulatory agencies are in a near paralyzed state, unable to break out of a broken model of how their products are developed or commercially approved. We need a jailbreak. We live in a time of economic crisis because of the relentless and exponentially escalating costs of health care, but we’ve done virtually nothing to embrace or leverage the phenomenal progress of the digital era. That is about to change. Medicine is about to go through its biggest shakeup in history.

This book is about the creative destruction of medicine, of how medicine will inevitably be Schumpetered in the coming years, and why it is vital for consumers to be fully engaged. Without the active participation of consumers in this revolution, the process will be inexorably slowed. All the other forces that could come to bear—doctors, the life science industry, government, and health insurers—are incapable of catalyzing this transformation. At the same time, the democratization of medicine is taking off. You, the consumer, are going to be needed to make it happen.

There is one theme, one reason, why this creative destruction is ready to go. It is because for the first time in history we can digitize humans. You know about digitizing pictures and information like books, newspapers, and magazines. It seems that everything now is digitized and widely transferable. You can download a two-hour movie in seconds. But that is a world apart from digitizing a human being.

Digitizing a human being is determining all of the letters (“life codes”) of his or her genome—there are six billion letters in a whole genome sequence. It is about being able to remotely and continuously monitor each heart beat, moment-to-moment blood pressure readings, the rate and depth of breathing, body temperature, oxygen concentration in the blood, glucose, brain waves, activity, mood—all the things that make us tick. It is about being able to image any part of the body and do a three-dimensional reconstruction, eventually leading to the capability of printing an organ. Or using a miniature, handheld, high-resolution imaging device that rapidly captures critical information anywhere, such as the scene of a motor vehicle accident or a person’s home in response to a call of distress. And assembling all of this information about an individual from wireless biosensors, genome sequencing, or imaging for it to be readily available, integrated with all the traditional medical data and constantly updated. We now have the technology to digitize a human being in highest definition, in granular detail, and in ways that most people thought would not be possible, if even conceivable, for many decades to come.

 

FIGURE INTRO.1: The transformation from medicine today (old, dumbed down) to new, individualized medicine that is enabled by digitizing humans.

This is a story about an unprecedented super-convergence. It would not be possible were it not for the maturation of the digital world technologies—ubiquity of smart phones, bandwidth, pervasive connectivity, and social networking. Beyond this, the perfect digital storm includes immense, seemingly unlimited computing power via cloud server farms, remarkable biosensors, genome sequencing, imaging capabilities, and formidable health information systems.

Think of the cell phone, which is a hub of telecommunications convergence but also a remarkable number of devices all rolled into one gadget: camera, video recorder, GPS, calculator, watch, alarm clock, music player, voice recorder, photo album, and library of books—like a pluripotent stem cell. Armed with apps it carries out diverse functions from flashlight to magnifying glass. Then connect it to a wireless network, and this tiny device is a web surfer, word processor, video player, translator, dictionary, encyclopedia, and gateway to the world’s knowledge base. And by the way, it even texts, emails, and provides phone service. But now picture this device loaded for medicine, capable of displaying all of one’s vital signs in real time, conducting laboratory analyses, sequencing parts of one’s genome, or even acquiring ultrasound images of one’s heart, abdomen, or unborn baby. This embodies a technological convergence, a coalescence of distinct and far-ranging functionalities, from elemental forms of communication to the complexities of medicine.

These are the collective tools that lay the groundwork for digitizing humans. This is a new era of medicine, in which each person can be near fully defined at the individual level, instead of how we practice medicine at a population level, with mass screening policies for such conditions as breast or prostate cancer and use of the same medication and dosage for a diagnosis rather than for a patient. We are each unique human beings, but up until now there was no way to establish one’s biologic or physiologic individuality. There was no way to determine a relevant metric like blood pressure around the clock while a person is sleeping, or at work, or in the midst of an emotional upheaval. This represents the next frontier of the digital revolution, finally getting to the most important but heretofore insulated domain—preserving our health.

We have early indicators that this train has left the station. The first individual—a five-year-old boy—who had his life saved by genome sequencing was only recently documented. And this led to the first health insurance coverage of genome sequencing. But it’s not just about finding the root molecular cause of why an individual is sick. We can now perform whole genome sequencing of a fetus to determine what conditions should be watched for postnatally. At the other end of the continuum of life, we can do DNA sequencing to supplant a traditional physical autopsy, to determine the cause of death. We can dissect, decode, and define individual granularity at the molecular level, from womb to tomb.

That’s just the start of illuminating the human black box. Recognizing that we are walking event recorders and that we just need biosensors to capture the data, and algorithms to process it, sets up the ability to track virtually any metric. Today these sensors are wearable, like Band-Aids or wristwatches. But soon enough they will also be embedded into our circulation in the form of nanosensors, the size of a grain of sand, providing continuous surveillance of our blood for the earliest possible detection of cancer, an impending heart attack, or the likelihood of a forthcoming autoimmune attack. Yes, this does ring in the sci-fi concept of cyborgs, the fusion of artificial and biological parts in humans. We’ve already been there with cochlear implants for hearing loss, a trachea transplant, and we’re going there in the creation of embedded sensors that talk to our cell phones via wireless body area networks in the future. With it comes the familiar “check engine” capability that we are accustomed to in our cars but never had before for our bodies. Think true, real prevention for the first time in medical history.

While this may seem a bit too futuristic, in the context of the information era it may appear to be eminently more realistic. We live in an extraordinary data-rich universe, a world that had only accumulated one billion gigabytes (10⁹ or 1,000,000,000 bytes of data) from the dawn of civilization until 2003. But now we are generating multiple zettabytes—each representing one trillion gigabytes—each year and will exceed thirty-five zettabytes by 2020, roughly equivalent to the amount of data on two hundred fifty billion DVDs.¹ Sensors are now the dominant source of worldwide-generated data, with 1,250 billion gigabytes in 2010, representing more bits than all of the stars in the universe.² The term “massively parallel” is an important one that in part accounts for this explosion of data and brings together the computer, digital, and life science domains. Note the convergence: from single chips that contain massively parallel processor arrays, to supercomputers with hundreds of thousands of central processing units, to whole-genome sequencing that is performed by breaking the genomes into tiny pieces and determining the life codes in a massively parallel fashion.

In 2011, the Watson IBM computer system beat champion humans in the game of Jeopardy. Watson is equipped with a 15-terabyte (10¹²) or 15,000,000,000,000-byte databank and massively parallel 2,880-processor cores.³ So beyond its television premiere and victory, where is Watson first going to be deployed? At Columbia University and the University of Maryland medical centers to provide a cybernetic assistant service to doctors.⁴ David Gelernter’s op-ed in the Wall Street Journal, “Coming Next: A Supercomputer Saves Your Life,” introduced the concept of a WikiWatson, which could bring together the whole world’s medical literature and clinical expertise. ⁵ Putting a massive databank to use to improve health care is emblematic of the overlay of the digital and medical worlds.

By now I hope I have made my preliminary case for super-convergence abundantly clear. But just having these technological capabilities will not catapult medicine forward. The gridlock of the medical community, government, and the life science industry will not facilitate change or have the willingness to embrace and adopt innovation. The U.S. government has been preoccupied with health care “reform,” but this refers to improving access and insurance coverage and has little or nothing to do with innovation. Medicine is currently set up to be maximally imprecise. Private practice physicians render medicine “by the yard” and are rewarded for doing more procedures. Medical care is largely shaped by guidelines, which are indexed to a population rather than an individual. And the evidence from clinical research is derived from populations that do not translate to the real world of persons. The life science industry has no motivation to design drugs or devices that are only effective, however striking, for a small, well-defined segment of the population. At the same time, the regulatory agencies are entirely risk-averse and, as a result, are suppressing remarkable innovative and even frugal opportunities to change medicine. The end result is that most of our screening tests and treatments are overused and applied in the wrong individuals, promoting vast waste. And virtually nothing is being done to accelerate true prevention of disease.

But the practice of imprecise medicine has not yet emboldened consumers to demand more, despite increasing awareness of the problem. Many patients now trust their peers on social networks—online medical communities such as PatientsLikeMe—more than their physicians. In some health care systems, patients can directly download their laboratory reports and medical records, which they were never allowed to do in the past. Any consumer with adequate funds can have his or her genome scanned or even wholly sequenced. In parallel and intersecting with super-convergence, we are now finally moving toward the democratization of medicine.

When the revolutions were occurring in 2011 in Tunisia and Egypt, predominantly propelled by the young oppressed citizens who could express and organize themselves via social networks and exploit the digital world, sharing pictures and videos, I tweeted: “Tunisia . . . Egypt . . . American medicine?” In fewer than forty characters, this conveyed my sense of urgency for consumers to provide the impetus for new medicine—a new medicine that is no longer paternalistic, since the doctor does not necessarily know best anymore. The American Medical Association has lobbied the government hard for consumers not to have direct access to their genomic data, that this must be mediated through physicians. We know that 90 percent of physicians are uncomfortable and largely unwilling to make decisions based on their patients’ genomic information. But it is your DNA, your cell phone, and your right to have all of your medical data and information. With a medical profession that is particularly incapable of making a transition to practicing individualized medicine, despite a new array of powerful tools, isn’t it time for consumers to drive this capability? The median of human beings is not the message.⁶ The revolution in technology that is based on the primacy of individuals mandates a revolution by consumers in order for new medicine to take hold.

Now you’ve probably thought “creative destruction” is a pretty harsh term to apply to medicine. But we desperately need medicine to be Schumpetered, to be radically transformed. We need the digital world to invade the medical cocoon and to exploit the newfound and exciting technological capabilities of digitizing human beings. Some will consider this to be a unique, opportune moment in medicine, a veritable once-in-a-lifetime Kairos.

This book is intended to arm consumers to move us forward. In the first section, I review the overall digital landscape—how the digital world has evolved and changed our lives outside of medicine; how our information in medicine is grossly deficient and population-based; and how consumers, despite progress toward convergence of health information, are too often poorly informed.

In the second section, I drill down into each of the four areas of digital medicine—wireless sensors, genomics, imaging, and health information—and lay out a vision of how these technologies will converge. In the last section, I preview the impact that digitizing humans will have on doctors and hospitals, on the life science industry and regulatory agencies, and, ultimately, on the individual.

As with any revolution, there are important downsides to consider. Here the concerns include the reduction of direct human contact and healing touch that may accompany increasing reliance on remote monitoring and avoidance of hospitalizations or even in-person office visits. It will be increasingly tempting for physicians to treat the virtual human being—the scan, the DNA results, the biosensor data—instead of the real patient. There is legitimate worry about adoption of new technologies before they have been adequately vetted and validated, or proven to be cost-effective and ideally cost saving. And certainly data deluge and the inability to efficiently transform the massive data sets into information and knowledge loom large. An extension of data flow issues brings us to the worry about security and privacy of digitized medical information. Ironically, the technological triumph of being able to digitize human beings creates a convergence of the real and virtual individual, and there will be legitimate worries about depersonalization, about treating the digital information instead of the individual. Ultimately, you will have to decide about the trade-offs of medicine Schumpetered. This book is intended to put you in position to be ready and knowledgeable to make that decision.