Fri, Jul 31, 2015 | Dr. Robert Goldberg
Pessimists vs. Progress
If the latter part of the 20th century was the era of the sustainable planet, the 21st century will be the age of the sustainable human. It will be an era of cures characterized by the accelerating capacity to diagnosis, stop, and prevent diseases. Infant mortality rates will plummet. Cancer, immune disorders, and illnesses such as Alzheimer’s will be preventable or manageable.
Living well past 90 or 100 will be commonplace across the planet. Our cognitive, physical, and cosmetic vitality will not erode as the years pass, because wellness will be sustained and enhanced through better nutrition and regenerative medicine. As people remain active and energetic for decades, both the absolute number and percentage of people retiring in the old fashioned way will decline. And as TEDMED curator Jay Walker observes "There is going to be a trillion-dollar business in keeping us healthy."
We have the scientific knowledge, the wealth and the imagination to achieve this vision. The exponential technologies—the tools to continually double performance and slash the cost and time required to produce innovations by half—either exist or are being developed. Cures could become America’s leading industry and principal export, and yield enormous economic and political benefits.
And yet, our nation lacks a cure strategy (a term coined by Jim Pinkerton) to achieve these benefits. On the contrary, most health care experts warn that a tidal wave of new medicines will have a tsunami effect across our entire health care system and that far from improving health and reducing the cost of disease, medical innovation stands in the way of solving a public health crisis. Others, such as Ezekiel Emanuel, proclaim that after age 75, we begin to fall apart, and that living longer imposes a huge financial burden on society: “This manic desperation to endlessly extend life is misguided and potentially destructive.”
Pessimists are actively campaigning against cures. Even as some elected officials seek to reform the scientific institutions that support or govern innovation, pessimists are warning against doing too much, too fast. Indeed, they want even more government control over how research is done, how quickly new cures can get to people, and at what price.
To create a social movement for cures, the prevailing pessimism must be overcome. This enterprise is critical to progress because social and political movements are essential to sustaining medical innovation. In the past, progress occurred because social movements overcame the pessimistic resistance of the time and turned a demand for cures into a national strategy. Franklin Roosevelt called upon the nation to support a national war against disease at home with the same vigor and resources dedicated to turning scientific insights into products that helped win World War II. FDR also launched the National Foundation for Infantile Paralysis, an advocacy group to advance research on and publicize polio. It inspired the formation of the March of Dimes campaign, which raised $1 billion of today’s dollars.
Mary Lasker, Sidney Farber and others organized a sustained lobbying and public relations effort to create the National Institutes of Health and provide it with significant funding. They went on to launch the first war on cancer in the 1940s and were responsible for Nixon’s war on cancer too. The organized outrage of HIV activists compressed the time required to develop and broadly distribute medicines to stem the epidemic. Breast cancer activists stormed the gates of Genentech to demand immediate access to Herceptin, leading President Clinton to direct the FDA to put cancer drugs on the faster tracks established for HIV. Craig Venter and Lee Hood’s resourcefulness and resolve captured the imagination of the world and demonstrated that sequencing the human genome opened yet another frontier for America. Without the leadership and vision of Bill Gates’ efforts the campaign to cure polio, measles, malaria, and TB would not be possible.
Why have cure campaigns made progress possible? Because they are the catalyst and conduit for the ideas needed to solve problems. They force systems to adapt and change. They spur and accelerate the exchange of ideas and the creation of networks, creating what Friedrich Hayek called ‘catallaxy’—the spontaneous order created by exchange and specialization in order to solve problems with collective intelligence. In today’s techno-terms, they created network effects before the Internet was born.
Ironically, past cure movements produced progress and benefits the pessimists of the time thought impossible. During the Depression, poor health was considered by many Depression-era Americans to be a matter of fate. The gains in health care between 1900 and the present have been spectacular. Life expectancy at birth in the Western world grew from a mere 45 years at the beginning of the 20th century to nearly 80 years at the dawn of the 21st century. More than 100 infants, and about an equal number of mothers, died for every 1,000 live births in 1900. Both the infant mortality rate and deaths of women during childbirth have become rather negligible. The incidence of contagious and other diseases also drastically declined, especially during the second half of the century. Death rates in the U.S. from heart disease are less than half of what they were in 1950, and survivor rates from many forms of cancer have improved during the past two decades.
The cost of health care has actually declined as new treatments replace more expensive and less effective services, particularly surgery and hospitalization. Each time new medicines are introduced, the ‘pessimistas’ shriek about how they will bankrupt our health care system. Hospitalization rates for cancer, heart disease and HIV have dropped dramatically from their peaks in the 1990s. It would cost an additional $10 billion a year to hospitalize people with HIV at the 1995 peak rate of 57 per 100000. Breast cancer hospitalization rates have been cut by nearly 70 percent, saving $5 billion per year. And the cost of medicines? It’s remained at about 10 percent of total health care spending since 1960.
Meanwhile the economic value of longer and better life—not counted in our GDP —has soared all across the world. Between 1960 and 2000, economic welfare from health care expenditures appear to have contributed as much to economic welfare as the rest of consumption expenditures, as measured by GDP, or about $9 trillion.
A recent government study looked at the economic value of reducing just disease related disability for 30 diseases between 1990 and 2010. It concluded that it generated $1 trillion. The Pessimistas claim that particularly in cancer, the cost of innovation is too high because most new medicines, for the most difficult to treat and advanced forms of cancer, add only a few months of life on average. In fact, the BEA study found that cancer treatments were responsible for nearly 80 percent of the total decline in disability plagued life years in the United States between 1990-2010. That generated nearly $800 billion in health value. And as Columbia University economist Frank Lichtenberg found: the cost of new cancer drugs (developed in 1995) is less than 1% of the nearly $5 trillion health value of the mortality reduction.
In fact, if we can apply this ‘cure’ for medical spending to more people as they age, we can create what Dan Perry and Jay Olshansky call ‘the longevity dividend’. As they note: “Slowing the aging process by an achievable three to seven years would simultaneously postpone all fatal and nonfatal disabling diseases, produce gains in health and longevity equivalent to cures for major fatal diseases, and create scientific, medical, and economic windfalls for future generations that would be roughly equivalent in impact to the discovery of antibiotics in the 20th century.”
Medical innovation has already become the main reason that Medicare spending has been declining for 40 years, as more people live healthier, longer lives. Disability has fallen by about 2 percent a year, saving nearly $1 trillion over the past two decades. And after age 65 people are working more and are more productive. If the decline in disability remains 2 percent, by 2030 people over 65 would add $6 trillion in annual income and $1.9 trillion in tax revenues (assuming tax rates are held constant). Medicare would spend $500 billion less each year.
The economic gains are likely to be even greater. For instance, just delaying the onset of Alzheimer’s by 5 years would generate $17 trillion of health value over 20 years. As Jim Pinkerton put it: “Do you want to make a dent in future health-care costs? Cure Alzheimer’s. That's where the cost will be as the health of the baby boomers falter. Insurance isn't the key. It was never the key. It's a product. Cure and care are the words of the future.
The Future: The Network Effect Disrupts Medical Innovation
The pace of innovation is accelerating exponentially. Systems biology—which deciphers the networks of interaction between and within cells that regulate health and disease—is the Internet of Things for cures. Lee Hood, the co-founder of the Institute of Systems Biology and the inventor of the automated DNA sequencer and synthesizer, has pioneered the network of network concept and applied it to medical innovation.
Similarly, Hood is harnessing the dramatic pace at which genomic, transcriptomic, metabolomics, and proteomic technologies have digitized biological data and its analysis. He has turned every cell into a ‘device’ that can share and process information. In essence, he has created a network of billions of devices sharing information in digital form. Every cell is a little computer that shares and creates information that creates a series of intra and interconnected networks. Genetic networks communicate with molecular and cellular networks that in turn create organ networks. We can now see how the networks change over time and with perturbations or distress, as well as how these networks functions to produce disease or healthy phenotypes.
Hood predicts: “Within the next 10 years, we should be able to sequence entire genomes in less than an hour’s time at the cost of a few hundred dollars. This will provide crucial insights into optimizing our wellness. In 10 years, we may have a little hand-held device that will prick your finger, make 2,500 blood measurements, and will longitudinally follow the organ-specific proteins for 50 different organs. This will allow us to detect many diseases at the earliest detectable phase - weeks, months, and maybe years before symptoms appear.
But more importantly, as Hood points out, systems medicine reduces the time and cost required for creating the social networks that demand and undertake the sharing of data needed to produce cures. Eric Topol observes that just as the printing press led to the rapid diffusion and sharing of knowledge far beyond a small elite, smartphones and the digitization of our biology is allowing “..Consumers to take that data and learn from it, read it, and get facile with it. It extends to genomics and understanding the drug interactions with one's own genome. It's going to extend in every which way where there's a data information domain in the hands of consumers.”
Patient-activated social networks are already using big data and analytics as Topol describes. The democratization of data is converging with systems medicine. This synergy is leading to what Hood defines as P4 medicine, medicine that is predictive, preventive, personalized, and participatory. Medicine will focus on each individual. It will become proactive in nature. It will increasingly focus on wellness rather than disease.
Hood notes, “instead of medicine focusing on disease as it does today, the focus in the future will be on wellness. Regular check-ups will allow the physician to longitudinally follow each patient and an individual’s wellness can be preserved without the disease state ever occurring. Individuals will be their own control in establishing a wellness baseline, monitoring the progression to disease state, and monitoring treatments that will perturb the systems back to a healthy state.
P4 medicine will be able to reduce sharply the escalating costs of health care to the point where we will be able to export it to the developing world. That will lead to a democratization of health care, a concept unimaginable five years ago.”
A Cure Strategy: Capitalizing on the Network Effect
A cure strategy should foster the democratization of medical innovation and support the creation of the catallaxy that is the crucible of progress.
1. Promote crowd curing
While proposals to reduce the time the FDA takes to review and approve a new product are welcome, they still regard randomized clinical trials as the heart and soul of medical progress. In fact, RCTs achieve a ..false certainty…neutralizing patient-specific variation in studies that include as many people as possible.
While the FDA and academic researchers are using new tools to measure individual differences they have not tapped into collective and interconnected data cloud around each individual patient.
A cure strategy would increase the bandwidth required to expand and accelerate connectivity to take on noncommunicable diseases such as Alzheimer’s, cancer, and heart disease. Why not invest $50 billion to support the hundreds of crowd curing communities that already exist? Studying the real world experience of millions of people using digital tools, and sharing the data and real world experiences of patients using Big Data analysis, allows systems biology and crowd sourcing technologies to more quickly match people to the best treatments.
2. Pay for Cures
Project Bioshield also established a fund for making multi-year purchases of new vaccines, devices, and medicines if and when they were developed. This increased the research and development of such products. Unfortunately, the agency in charge of this effort, The Biomedical Advanced Research and Development Authority (BARDA) saw this money diverted to other uses by politicians. BARDA only has $400 million a year to spend on cures. Why not allocate billions to innovations that eradicate cancers, Alzheimer’s, or other illnesses that, left untreated, cost Medicare and Social Security trillions?
3. Make Cures a Centerpiece of Foreign Aid
Why not make the purchase and donation of cures as centerpieces of foreign aid and development assistance? For instance, the United States currently spends x billions a year in foreign aid, mostly for military, etc. Purchasing cures and re-selling them at a cost competitive in global markets would bolster American leadership in biomedical innovation. Further, we should fund capacity to use cures. Organizations such do an effective job in building cure capacity in developing countries, but struggle for resources and lack of partners.
4. Add The Value of Health To Our Measurement of GDP
Pessimism about medical innovation is also due to policymakers and the media focusing exclusively on the cost of new technologies and ignoring the value to consumers and stakeholders.
As University of Chicago health economists Tomas Philipson states: “Health care insurance ensures access to health care; stated another way, this insurance provides access to medical innovations already developed. It is the innovations in treatment over the past century that partly protect us against the loss of actual health when disease hits.
Medical innovation, therefore, is the key to true health insurance since it is the primary method by which the future risk of losses in health itself is reduced over time, and can thus be viewed as serving the role of insuring future health. In essence, medical innovation reduces the true price of health.”
Philipson has called for measuring how much innovation reduces what it costs to stay healthy longer. Indeed, The U.S Department of Commerce Bureau of Economic Analysis established Health Care Satellite Accounts to do just that. Years in the development, the accounts measure output “provided to patients as the treatment of disease (for example, cancer or diabetes) rather than the specific types of medical care that individuals purchase (such as visits to a doctor’s office or the purchase of a drug), as is currently published.”
Congress and every executive agency should be using the new health satellite accounts to measure health care consumption on disability, productivity, and premature death from disease. And health plans should be required to provide data on the impact of their practices on these social indicators.
5. Make Access To Cures A Civil Rights Issue
Increasingly, insurers are making it harder for people to access cures. They require chronically ill people to fail first on older medicines (i.e., have their condition get worse. Insurers have also placed most or all medications for cancer, HIV/AIDS, multiple sclerosis, and many other chronic diseases including generics, on the highest cost-sharing tier health plans. Finally, health plans are refusing to pay for the kind of systems medicine information that is crucial to finding the right treatments for the most advanced and complex illnesses.
Together, these practices amount to a systematic effort to discriminate against people with pre-existing conditions, violating the spirit and letter of the provision of the ACA that makes such policies illegal. In time, the health insurance business model will be destroyed in favor of a wellness industry based on P4 medicine. But for now people are being denied access to cures because they are chronically ill. That is immoral and it should be illegal.
Can A Cure Strategy Succeed?
In “The Emperor of all Maladies” Siddhartha Mukherjee’s history of the war on cancer notes that the turning point in the battle came when Mary Lasker and Sidney Farber “stumbled upon an unshakable, fixed vision of a cure—and they would stop at nothing to drag even a reluctant nation toward it.”
Farber wanted to attack all cancers but everywhere he turned the pessimists prevailed. Pediatricians at the Children’s Hospital in Boston where Farber was treating patients claimed that he was wasting time and money on children who were going to die anyway. His paper describing the remission was received, as one scientist recalls, “with skepticism, disbelief, and outrage.” Farber was undeterred. As Mukherjee writes: “He needed a larger drive, a larger platform, and perhaps a larger vision for cancer. ” He established a social movement to carry out his cure strategy.
Our nation is at a similar inflection point. Today new therapies are curing Hepatitis C and beating the most advanced and deadliest cancers into long-term remission. Yet the pessimists are launching an assault on the development and use of medical innovation, just as the previous generation of pessimists did when Farber wanted to expand the use of cancer drugs to anyone dying.
Today patient-activated social networks are increasingly connected in the effort to come up with cures. They are accelerating the spread of innovation at a pace Farber would find satisfyingly astonishing. Despite the best efforts of the pessimists, the direction and use of innovation is becoming democratized. As Schrage observes “the accelerating spread of innovation ultimately amounts to the greatest revolution in choice the world has ever known.”
In “Democracy in America”, Alexis de Tocqueville wrote “From the time when the exercise of the intellect became a source of strength and of wealth, we see that every addition to science, every fresh truth, and every new idea became a germ of power placed within the reach of the people.” The engine of progress was a free people sharing knowledge. It is today. Over the past 50 years, cure strategies in America have imagined a better world and turned social action into a potent tool for spreading medical innovation.
This power is stronger than ever, shared more widely and rapidly than at any time in our nation’s history. The pessimists will object, but their predictions will fade as they have before. The 21st century will be an era of cures, led by Americans.
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