Breakout: Pioneers of the Future, Prison Guards of the Past, and the Epic Battle That Will Decide America's Fate

by Newt Gingrich

  A centralized bureaucratic healthcare system was a bad idea even in the era of “one-pill-fits-all” medicine. It consistently resulted in lower-quality healthcare at a higher price. But such a system is positively deadly in an era when we can customize treatment to each person’s age, height, weight, and gene type, not to mention blood pressure, cholesterol, heart rate, blood oxygen level, and more.

  Obamacare takes the population medicine that Dr. Topol bemoans to the extreme. The law gives the federal Department of Health and Human Services authority to determine what, exactly, health insurance will cover. Secretary Sebelius famously exercised this prerogative in 2012 to mandate that all insurance policies include free contraception, but the authority reaches far beyond dispensing birth control. HHS bureaucrats will determine which treatments people get (i.e., what insurance will cover). As the American Spectator reports, the secretary of HHS will “determine what type of insurance coverage every American is required to have. She can influence what hospitals can participate in certain plans, can set up health insurance exchanges within states against their will, and even regulate McDonald’s Happy Meals.”11

  Even more grotesquely, the law establishes the Independent Payment Advisory Board (IPAB) to make large cuts to Medicare without Congress’s bearing any political pain. The board will determine what drugs, procedures, and therapies are covered and how much healthcare providers (doctors and hospitals) are paid for them. This board of unelected experts (who, once confirmed, essentially cannot be fired) will have an enormous effect on the medical treatment of millions of Americans on Medicare. And because Medicare is such a large force in the healthcare system, the IPAB will affect how the rest of us are treated as well. One central board of experts making decisions for an entire country on Medicare coverage? This is the epitome of population medicine.

  Will Medicare cover the nanosensors that Dr. Topol predicts will warn of heart attacks before they happen? Will it pay for the blood glucose-level monitors for diabetics? Will it cover drugs that are customized just for you? The IPAB experts will decide. All we know for sure is that the board’s ultimate aim is to cut costs, not necessarily to improve care.

  In the end, bureaucratic healthcare and population medicine fail for the same reason: the so-called “experts” can never know enough about the needs of individual patients to provide them the best care, so they lump people into large classes and treat them all the same. That is to say, they often give everyone mediocre treatment.

  There’s another reason Obamacare threatens the breakout in medicine: its cost, both for people purchasing health insurance and for taxpayers. The House Energy and Commerce Committee recently reported that “consumers purchasing health insurance on the individual market may face premium increases of nearly 100 percent on average, with potential highs eclipsing 400 percent.”12 The Congressional Budget Office now estimates the law will cost taxpayers $1.8 trillion by 2023, double the original projection.13 And that was before the administration announced it would offer subsidies to purchase insurance on the exchanges on what Reuters described as “the honor system” until at least 2015, because the government was incapable of implementing a verification system even three years after the law was passed.14

  That cost will come at the expense of some real innovations like the ones Dr. Topol described. To help cover the legislation’s enormous cost, Obamacare includes a tax on medical devices, a tax that the FDA, to no one’s surprise, is now interpreting broadly. The agency plans to treat health-related mobile apps, of which there are already more than a million, as medical devices.15 Smartphone-linked sensors will be regulated and taxed by the federal government. Free nutrition apps, WebMD, and even the Nike FuelBand could be as well if they make medical recommendations.

  My friend Dr. Tim Rowe directs the Vertebrate Paleontology Laboratory at the University of Texas at Austin. When I visited recently, he showed me how his team, which used to spend hours extracting fossils from rock and cleaning them, can now simply CAT scan an embedded fossil in its crate, make an exact digital model, and reproduce it with a 3-D printer. The scientists end up with a perfect replica without ever touching the original specimen. (You can watch our conversation about this project at www.BreakoutUniversity.com.)

  Tim mentioned in passing that doctors will soon use the same technology on persons who need hip replacements. They’ll CAT scan a patient’s hip, use the imaging to develop a digital model of the bone, and print out a replacement that perfectly matches the patient’s hip joint. The medical applications of 3-D printing had not previously occurred to me, and they illustrate two useful concepts. First, Tim has been using this technology in his fossil lab for more than ten years—in fact, he launched an online database at Digimorph.com in 2002 to distribute his fossil models all over the world for free—yet the technology still has not made its way into most hospitals. Second, getting this clinically proved technology into hospitals will take even longer because of Obamacare. The technology will be regulated by the FDA, and the same machines will be taxed as medical devices.

  Obamacare takes exactly the wrong approach to healthcare reform. Instead of encouraging medical breakthroughs, it hinders them and slows their adoption. The story of ten-year-old Sarah Murnaghan vividly illustrates the point. Her suffering is a preview of the cold and impersonal bureaucratic health system that Obamacare is only beginning to usher in.

  Sarah was born with cystic fibrosis. By the time she was ten, she was on oxygen virtually around the clock. She desperately needed a lung transplant—preferably a pediatric lung, one suited to her size. Pediatric lungs are only rarely available for transplant, however, and by the spring of 2013, Sarah’s doctors worried that she would not get a new lung in time to save her life. Her doctors decided, therefore, to approve her for an adult lung transplant. They were confident she would do well with a set of adult lungs pared down during the surgery. They added her to the adult transplant list.

  Organ transplants are managed by the Organ Procurement and Transplantation Network (OPTN), established by Congress and overseen by HHS, which allocates available organs according to the urgency of a patient’s need and his prospects for recovery. OPTN gave Sarah Murnaghan a high priority, an evaluation that should have put her near the top of the list and virtually assured her of receiving the transplant her doctors said she needed. There was only one problem: Sarah was fourteen months shy of her twelfth birthday, and twelve was the youngest age for eligibility for an adult transplant. When the OPTN system was created a decade earlier, in 2004, the number-crunchers felt there were not enough data to evaluate younger patients—so they were simply excluded from consideration.

  The transplant bureaucracy therefore placed Sarah at the bottom of the list despite the urging of doctors at the Children’s Hospital of Philadelphia (among the best pediatric hospitals in the world).

  The OPTN policy was practically a death sentence for any child under the age of twelve in need of a lung transplant. No matter how well suited for an adult lung their doctors judged them to be individually, the abstract, population-level transplant bureaucracy would never allocate them an organ until every single patient on the list over the age of 12 had either refused it or received a transplant of their own. The under-twelve exclusion essentially said that because so few children needed new lungs, the children who required them couldn’t have them.

  It sounds crazy that official policy would deny medically sound organ transplants to ten-year-old children while giving them to older, less severely ill adults. For Sarah Murnaghan and children like her, however, it was deathly serious. According to a letter prepared by a lawyer for Sarah’s family, 62 percent of the children on the waiting list in 2011 died before they got a transplant, compared with just 26 percent of the adults. If OPTN simply allowed children to be included in the adult rankings when their doctors judged an adult lung transplant medically appropriate, this disparity would have been far less dramatic.

  The policy that was senseless and cruel in individual c
ases was no doubt the product of good intentions. The officials at OPTN, armed with statistics about adult transplants, crafted an algorithm to calculate, at the population level, the optimum allocation of scarce resources. Since the statistical evidence for children didn’t meet their standards of significance, they excluded the group from the scoring algorithm. A policy that made perfect sense to a central bureaucrat whose job was to solve an optimization function left a ten-year-old girl with a dire need of a new pair of lungs and a prognosis for a successful surgery permanently trapped at the back of the line.

  In the spring of 2013, Sarah’s lawyer wrote to the HHS secretary, Kathleen Sebelius, asking her to suspend the under-twelve rule. Secretary Sebelius declined to exercise that authority, saying she wouldn’t waive the pointless rule until it could be reviewed by the board of experts at OPTN. But Sarah didn’t have that long to wait. Finally, in an unusual move, a federal judge intervened and ordered the rule set aside. Sarah got her lung transplant, and as her doctors had said all along, the surgery was successful.16

  Systems that predictably produce policies like the under-twelve rule and stories like Sarah Murnaghan’s are worse than misguided; they are immoral. They’re flat-out wrong—but increasingly common.

  Although Sarah’s ordeal was not a product of Obamacare, it is a preview of the healthcare we can expect if the prison guards have their way. Impersonal and arbitrary bureaucratic rules—far removed from the judgment of individual patients and their doctors—will inevitably produce senseless suffering. The Obamacare law gave federal bureaucrats the authority to write thousands of rules that will determine everything from what treatments insurers will cover and how much doctors are paid to how the government handles your personal health information. And while rationing is unavoidable today with organ transplants, it will spread to other fields of medicine under Obamacare, and federal bureaucrats will continue to make rules as pointless and harmful as the under-twelve rule that almost killed Sarah Murnaghan. Sometimes the pernicious results of this bureaucratic rule-making will not be unintended. Interested individuals, industries, and ideologues will figure out how to influence the rules for their own purposes, regardless of what is best for patients.

  The prison guards who write these rules and would like to write more of them argue that we just need to tweak this or that policy or add such and such an agency. They believe problems like Sarah’s can be avoided with more money and more bureaucratic power. But “experts” can never know enough to make medical decisions for thousands or millions of people. The more they try, the more inhuman the health system will become.

  Still, doesn’t some public authority have to manage the allocation of scarce medical resources? As Secretary Sebelius pointed out in her comments on Sarah Murnaghan, somebody has to decide who gets a lung (and lives) and who doesn’t (and dies). Within the current system, that might be true. But it doesn’t have to be that way. Pioneers are working to change the current system. A breakout is on the way that could eliminate problems like the one Sarah faced.

  Regenerative Medicine

  Dr. Anthony Atala is working toward a day when Americans will not die while waiting for an organ donation. He envisions a world, much sooner than you might think, when instead of adding your name to a list and waiting for someone else to die, doctors will simply grow you a new organ—from you.

  Atala is one of the world’s leading doctors in the exploding field of regenerative medicine, which focuses on healing or replacing patients’ organs or tissues using their own cells rather than using drugs or relying on organ donations. He is the director of the Wake Forest Institute for Regenerative Medicine, where researchers are achieving remarkable, almost unbelievable, breakthroughs. They are literally growing organs in the laboratory that can become functional in the body.

  “Regenerative medicine is exciting because it really has the opportunity not just to manage disease, like a drug would, such as for someone with high blood pressure or diabetes, but really to cure it,” Atala told me. “It really is a totally different approach for medicine.”

  The first organs Atala and his team regenerated to be put in real patients were bladders. They started by extracting cells from a patient’s failing organs. Since each person’s cells are unique, they harvested the cells that “knew” how to be part of that particular organ. They put the cells in an incubator that matched the conditions of the human body. The cells began to reproduce, and soon Atala’s team had dishes full of new bladder cells belonging to their patients.

  A dish full of cells—even a dish full of bladder cells—doesn’t magically transform itself into a bladder. The cells need a shape to form around. So Atala and his team used a special biomaterial, similar to cloth, to stitch together a mold, or a “scaffold,” in the shape of a bladder. This scaffold would give the loose cells something to grab onto as they cohered into a new organ.

  The scientists carefully sucked up some of a patient’s new cells with a dropper and coated the bladder-shaped fabric. Then they returned the scaffold to an incubator that mimicked the conditions of the human body. A few weeks later, laboratory tests confirmed that the cells were attached to the scaffold.

  The scaffold was then transferred to the patient’s body, where it continued to develop. Within a few weeks, the biomaterial would dissolve and only the complete, healthy bladder would remain.

  This was the first time in history anyone had received a completely new organ grown in a lab. Today, Atala told me, “you have bladders that have been implanted into patients and we now have patients walking around for twelve years with their engineered organs.” But bladders were only the beginning for Atala and his team. They used similar processes to grow replacement urine tubes that were implanted in patients, and today they are working on organs and tissues for more than thirty different areas of the body, including muscles, arteries, blood vessels, heart valves, kidneys, and livers. In some cases they actually “exercise” the moving parts (like valves and muscles) as they grow the tissues to condition the cells to life in the body.

  Seeking to advance beyond the slow process of eyedroppers and fabric scaffolds, the team next discovered how to modify a standard inkjet printer, replacing the colored inks with different types of cells. Soon they built more-sophisticated printers and were 3-D printing pieces of bone in the lab as well as muscle and cartilage.

  What they’re working on today is even more astonishing. In a TED talk, Atala described the next generation of bioprinters, “where we print right on the patient.… You actually want to have the patient on the bed with the wound, and you have a scanner, basically like a flatbed scanner.… that first scans the wound on the patient, and then it comes back with the print heads actually printing the layers that you require on the patients themselves.”17 Today, Atala’s team is using this combination of scanning and printing experimentally, to treat surface wounds such as severe burns. It’s not hard to imagine that one day similar tools could perform regenerative surgeries on damage inside our bodies.

  3-D printers can already do more than just build bones and heal skin wounds. Atala demonstrates a machine that takes a 3-D scan of a patient’s kidney inside his body and digitally slices it up into thin layers. This information is used by a 3-D printer to “print” a prototype kidney by laying down scaffold material along with the patient’s own cells.

  Although these prototypes haven’t been tested in humans yet, Atala’s lab already has successfully implanted a mini-kidney in a steer that produced a urine-like substance. “We are growing kidneys in a laboratory right now,” he said. “Miniature kidneys have been implanted into animal models that show that urine can be produced. So these things are real. These kidney structures can be created, they can be implanted, and they can function.”

  The breakthroughs that Dr. Atala and others like him are pioneering could lead to the most important advances in medical care in generations. Many of the most difficult, most painful, most expensive, and most lethal health problems could simply ceas
e to exist if we could routinely regenerate organs.

  If your kidneys are failing today, you require dialysis, which takes many hours per day. Tomorrow, your doctor may instead print new ones. Today, nine out of ten patients waiting for a transplant are waiting for a kidney. That’s more than ninety-three thousand people. In 2011, almost five thousand people died waiting.18 Moreover, 355,000 Americans are on dialysis,19 therapy that costs taxpayers $20 billion a year. The annual cost of dialysis is a quarter of a million dollars per year per patient, according to Dr. Atala. A lab-grown kidney would be a bargain in comparison and of course would provide an enormous improvement in quality of life.

  Are you one of the nineteen million Americans who suffer from diabetes?20 Instead of living with a chronic disease for decades, you could one day get a new pancreas grown by your doctor. Since diabetes costs $245 billion every year, these too might be a bargain.21 Certainly, they’d be lifesaving for the 1,400 people now waiting for a transplant.22

  Children like Sarah Murnaghan, too, could simply wait a few days for their doctors to grow new sets of lungs from their own cells instead of waiting for a transplant that might never come. The shortage of organs today is severe. More than 119,000 people are in line for some kind of transplant in the United States. Eighteen people die every day waiting for an organ.23

  Many types of cancer, too, could be cured by replacing the affected organs with lab-grown alternatives: lungs, pancreases, breasts, colons, livers, and more might simply be swapped out for non-cancerous versions.

  Organ regeneration could eliminate many of the leading causes of death, giving us longer and healthier lives. Like a car in need of maintenance and some replacement parts at 150,000 miles, many persons might keep on going for decades with a little retooling.