Friday, February 10, 2012

Topol and Agus on the Future of Medicine

Speaker after speaker at the January 26, 2012 Care Innovations Summit in Washington, DC concluded that increasing the quality and decreasing the per-capita cost of health care is the dominant political, social, and economic issue of out time. More than one expert called for a “jailbreak.” Before January 26, “jailbreak” for me meant either an obscure English reality television show or an expression applied to overriding the software limitations deliberately placed on computer systems for security or administrative reasons. The speakers in DC seemed to be calling for a jailbreak out of the prison of the status quo of the American health care delivery system and into an era of digital medicine and understanding the ill patient as a complex emergent system that does not need to be fully understood to be cared for.

Two new books make the case that American medicine is at an inflection point and about to undergo “its biggest shakeup in history.” Eric Topol, MD in The Creative Destruction of Medicine: How the Digital Revolution Will Create Better Health Care (New York: Basic Books, 2012) is no fan of the traditional approach which he labels as “conservative to the point of being properly characterized as sclerotic, even ossified.” David B. Agus, MD in The End of Illness (New York: Free Press, 2011) applies systems biology to his field of oncology and concludes: “Cancer is not something the body has or gets; it’s something the body does.”

Medicine is notorious for being slow to catch up to the rest of the world. The following statement by H. Thomas Johnson, former President of the Academy of Accounting Historians, indicates that medicine is even more recalcitrant to change than accounting:

“Quantum physicists and evolutionary biologists now believe that it is best to describe reality as a web of interconnected relationships that give rise to an ever-changing and evolving universe of objects that we perceive only partially with our senses. In that systemic view of the world nothing is merely the sum of the parts; parts have meaning only in reference to a greater whole in which everything is related to everything else. The Cartesian/Newtonian worldview has influenced thought far beyond the physical sciences, and accounting is no exception. Double entry bookkeeping and the systems of income and wealth measurement that evolved from it since the 16th century are eminently Cartesian and Newtonian. They are predicated on ideas such as the whole being equal to the sum of the parts and effects being the result of infinitely divisible, linear causes. Why should accountants continue to believe that human organizations behave like machines if the scientists from whom they borrowed that mechanistic worldview now see the universe from a very different perspective? Never again should management accounting be seen as a tool to drive people with measures. Its purpose must be to promote inquiry into the relationships, patterns, and processes that give rise to accounting measures”

Having graduated from Case Western Reserve School of Medicine in 1980 and having trained at UCSF as an academic anatomic pathologist, I am steeped in the traditional approach to health care. The biomedical model reduces every illness to a biological mechanism of cause and effect, and physicians diagnose diseases and then treat them. Health is defined as absence of disease. The patient story and experience is subjective and untrustworthy in comparison to the test results emanating from my pathology laboratory, which are objective and true. Generalists are replaced by specialists who regard cure as the only important goal. And pathologists are the most important of the specialists because treatment selection and administration has to await the diagnosis rendered in the pathology laboratory.

Agus labels the traditional approach “the germ theory of disease, which dominated, and in many ways defined, medicine in the twentieth century.” “The treatment only cared about the invading organism…it didn’t care to define or understand the host (the human being).”

Agus, an academic oncologist and founder of both a proteomics and a genomics biotech start up company, replaces the medical status quo with a system biology approach. “It is important to approach your health in general from a lack of understanding. Honor the body and its relationship to disease as a complex emergent system that you many never fully comprehend.” His conclusion that one does not need to understand cancer to control it is controversial.

In discussing the recent Susan G. Komen/Planned Parenthood controversy, Susan Love, MD argues that finding the cause of breast cancer is far more important than refining the screening techniques we use today. Dr. Love concludes her article with “We must move breast cancer advocacy to the next level, beyond screening for cancers that are already there, even beyond the cure, to finding the cause. That is true prevention.” (

The human body is so complex that we may never really understand it, but the systems biology theory has already yielded new ways of helping patients. Zoledronic acid is a drug that affects bone metabolism to reduce fractures, but does nothing to cancer cells. And yet this drug has decreased breast cancer recurrence by 36%, presumably because it changes the environment of bones so that cancer does not spread so readily. Avastin is too large a molecule to get past the blood-brain barrier, but Agus describes how it is being used experimentally to treat some malignant brain tumors, perhaps by changing the pressure in the brain. The Mayo Clinic and Cincinnati Children’s Hospital have studied how the cytochrome P450 superfamily of genes affects the metabolism of drugs used in treating mental illness. Although we do not fully understand what causes these diseases, the GeneSightRx test for five genes has allowed physicians to tailor drug therapy to 12,000 patients’ individual metabolism.

Topol would replace the traditional approach to medicine with digital medicine. For Topol, digital medicine is now possible because of the convergence of genomics, wireless sensors, digital imaging, information systems, social networks, the ubiquity of smartphones, and the unlimited computing power of cloud server farms.

The iPad and the Kindle have forced us to come to grips with what it means to digitize a book. What does it mean to digitize a human being? The technology exists for every personal health record to contain our genome, our physiologic metrics such as blood pressure and brain waves measured morning, noon, and night, digital scans of any organ, and the cumulative radiation exposure from every scan and x-ray. When one realizes that all of this information can be readily available from our smartphones connected to the cloud, physicians will soon have a window into each person’s health and wellness that has implications across the continuum of care. In the emerging digital medicine, information at the point of care will ensure the most up to date treatment and the avoidance of the medication and coordination errors that plague current American health care delivery. There are 13,600 medical diagnoses, 4,000 medical procedures, and 6,000 medications currently available. This is precisely the kind of complex data problems that digital technology solves.

Topol, a cardiologist, proposes digitizing humans to identify those susceptible to heart attacks. Sequencing the genome for cardiac risk variants could be combined with identifying arterial lining cells that are sloughed off into the blood stream during the early stages of a heart attack. Individuals who are at high risk could be monitored with an implanted nanosensor that communicates with the patient’s smartphone. Topol even envisions eventually having the nanosensor automatically release medications in response to high levels of worrisome markers.

Agus, Topol and the speakers at the Care Innovations Summit all foresee a new paradigm of health care that will enable us to decrease the per-capita cost and increase the quality of care that Americans receive. Instead of waiting until a disease has developed or the patient visits the doctor once a year to diagnose and treat an illness, the patient will know what diseases are likely due to genetic predisposition and he will be monitored with wireless and implantable sensors so that the disease can be predicted and prevented. Instead of considering health to be absence of disease, we will embrace the WHO definition of a state of complete physical, mental, and social well-being. Instead of focusing on cures, we will concentrate on managing chronic diseases.

Agus and the others contemplate the end of disease which seems a little overly optimistic but intriguing nonetheless:

“Take a moment to imagine what it would be like to live robustly to a ripe old age of one hundred or more. Then, as if your master switch clicked off, your body just goes kaput. You die peacefully in your sleep after your last dance that evening. You don’t die of any particular illness, and you haven’t gradually been wasting away under the spell of some awful, enfeebling disease that began years or decades earlier.”

Thursday, February 2, 2012

Care Innovations Summit, January 26, 2012, Washington, DC

Anyone who is concerned about the future transformation of the United States clinical delivery system should pay attention to the Care Innovations Summit. The selection of presentations as well as the content that was discussed says volumes about where CMS believes payment is headed. Speaker after speaker stated that decreasing the per-capita cost of health care and increasing the quality patients receive is the dominant political, social, and economic issue for all Americans.

Marilyn Tavenner, the new Acting Administrator for the Centers for Medicare and Medicaid Services, outlined what she saw as the major accomplishments of the past few years. Her list included providing partial relief for 3.8 million seniors who hit the prescription drug “doughnut hole,” creating high risk pools for 45,000 Americans, creating a consumer website, allowing young adults to stay on their parents’ health care insurance until age 26, eliminating denial of coverage for patients with pre-existing conditions, eliminating lifetime and annual health care insurance maximums, increasing the coverage of many prevention measures, creating pilots to explore how to base payments on quality not volume, and getting the Innovation Center up and running.

Atul Gawande, MD, the Harvard surgeon and New Yorker author, presented the morning keynote. Gawande, the author of three books on health care (Complications, Better, and The Checklist Manifesto), said the “cost of health care is destroying the American dream.” In Massachusetts the state government sent nearly a billion dollars to local schools to pay for smaller class sizes and better teachers’ pay, but every dollar was diverted to covering higher health care costs. For each dollar added to school budgets, the costs of teacher health benefits took a $1.40.

Gawande listed three causes of our current health care problem: business interests, government bureaucracy, and the sheer complexity of delivering clinical care in a broken system. He focused on the last of these causes and noted that there are at present 13,600 diagnoses, 4,000 medical procedures, and 6,000 medications. In 1970 the average patient saw two physicians for their medical conditions; today the average patient has more than 15 physicians consulting on their care. He also stated that the health care system “trained and hired physicians to be cowboys, when what we really need are pit crew team members.” He is also hopeful because the health care systems that have the best results are not the most expensive.

The most successful health care systems utilize three skill sets that many in health care ignore: 1) Recognizing success and failure by using data. He observed that our current use of data is like “driving a care without a speedometer that only tells us how fast the other cars were going four years ago.” 2) Devising solutions by thinking like other fields that are high risk and high failure. His example was the checklist. 3) Overcoming the culture of resistance among physicians by implementing and spreading the solutions. He thought that medical schools have not done enough to install the values of humility, discipline, and teamwork in their graduates. He concluded by saying there is a battle for the soul of medicine and that we only have eight to ten years to solve our national problem.

Rick Gilfillan, MD, Director Center for Medicare and Medicaid Innovation, and Todd Park, Chief Technology Officer for the US Department of Health and Human Services, gave an overview of payment and data programs being championed by the Innovation Center. Parks described data “as rocket fuel for innovation” and presented four ways that CMS was going to be more transparent about data: 1) the Blue Button program where 500,000 veterans and Medicare patients have already downloaded their clinical data; 2) Data for ACOs program will provide aggregate reports for this new payment vehicle; 3) Medicare Data Sharing; and 4) Health indicators warehouse project.

Mohit Kaushal, MD, MBA, Executive Vice President and Chief Strategy Officer of West Wireless Health Institute, moderated a Care Delivery/Primary Care Innovation Case Study Panel. The panelists included Christopher Chen, MD, CEO of ChenMed, Frank Ingari, President and CEO of Essence Healthcare, Brian Prestwich, MD, Professor at USC, Lonny Reisman, MD, Chief Medical Officer of Aetna, and David P. Kirchhoff, President and CEO of Weight Wathers.

A number of conclusions were reached. There is a continuum of payment reform from fee-for-service to pay for performance to shared risk to full capitation, and different payment models work best for each step of the continuum. They also agreed that full capitation is coming. Dr. Chen and Mr. Ingari noted that physician culture must be changed and that you cannot manage providers in two cultures at the same time (fee-for-service vs. capitation). Dr. Prestwich emphasized the importance of using alternative providers to physicians and nurses; he uses occupational therapists and social workers to provide many transitions of care services. There was general agreement that current versions of electronic medical records (EMRs) do not provide usable data when and where it is needed to be successful under capitation. Dr. Reisman emphasized the need to activate patients and noted that even when Aetna paid for post myocardial infarction medications, half of the members did not take them. Mr. Kirchhoff related the success of a United Kingdom program where the NHS had physicians prescribe the weight watchers program to obese patients.

Dr. Gawande moderated a Care Delivery/Chronic Disease Innovation Case Study Panel. Panelists included Kenneth Coburn, MD, MPH, CEO of Health Quality Partners, Alan Hoops, Chairman and CEO, Wellpoint/CareMore, Debbie James, Vice President of Healthways Fitness Division, and Mary Naylor, PhD, RN, Professor of Nursing at the University of Pennsylvania.

All the panelists reported on their successful programs for taking better care of seniors with chronic diseases. Since the Congressional Budget Office reports that 5% of Medicare beneficiaries account for more than 43% of costs, and 25% account for 85% of Medicare spending, such programs will be essential for us to lower per-capita costs and increase quality. Ms. James reported that relatively simple steps (local gyms, special welcoming coaches at the gyms for seniors, targeted mailing and phone calls to patients with chronic diseases, and educating physicians to encourage fitness by giving a prescription to the gym) have increased participation in the Silver Sneakers fitness program. Dr. Coburn of Doylestown, PA uses a Sutter Health questionnaire to identify patients who would benefit from his nurses and their 35 transitions of care tools. Mr. Hoops uses predictive modeling tools and retrospective look backs of expensive patients to identify patients who need to be removed from the primary care physician panels and managed by special “extensivist physicians.” Professor Naylor emphasized the importance of specially trained nurse practitioners in delivering post discharge transitions of care. Naylor’s approach is nicely summarized in a recent Health Affairs article ( Gawande shared some of his observations about Dr. Jeffrey Brenner’s work in Camden, New Jersey where 900 people in two buildings accounted for more than four thousand hospital visits and about two hundred million dollars in health care bills ( Gawande in his keynote also shared CMS data that indicated that patients with heart disease, chronic kidney disease, diabetes, COPD, depression, rheumatoid arthritis, dementia, stroke, osteoporosis, and cancer are candidates for this transitions of care approach.

Simmi P. Singh, Senior Advisor, Health Innovation, Office of the Secretary, Department of Health and Human Services moderated the afternoon panel Cancer: Journey Toward Better Health, Better Care, and Lower Costs Case Study. Panelists included Amy Abernathy, MD, Associate Professor, Duke University, Amy Berman, RN, Program Officer, John A. Hartford Foundation, Jeffrey Elton, PhD, Co-Founder, Kew Group, Bruce Johnson, MD, Head of Thoracic Oncology, Dana Farber Cancer Institute, and Chris Olivia, MD, Board Member, Eviti.

Dr. Johnson discussed how genetics can subdivide adenocarcinoma of the lung into different types with new treatments. When genotyping an adenocarcinoma identifies that the driver mutation for that tumor is the EGFR gene, oncologists have had successful clinical responses by treating with the oral medication Gefitinib. Other adenocarcinomas of the lung reveal that the driver mutation is the Alk+ gene that responds to the oral agent Crizotinib. In the past these lung cancers were all lumped together as adenocarcinoma as revealed by light microscopy. Drs. Elton and Olivia described competing approaches where lung cancer patients could be treated in the community by general oncologists, buts still receive the latest evidence based medicine treatments such as those described above for lung cancer. I was a little surprised that none of the panelists mentioned that 60% of melanoma patients have a specific point mutation (V600E) in the driver mutation BRAF gene that can be treated by an orally active BRAF mutation directed drug that specifically binds the mutated protein with an 80% response rate. There was also discussion of the need for new business models; in the United Kingdom the NICE has approved some of these expensive cancer drugs as long as the company gives the NHS a rebate for the patients who do not respond.

Susan Dentzer, Editor-in-Chief of Health Affairs, interviewed Jonathan Blum, Deputy Administrator and Director for the Center of Medicare at the Centers for Medicare and Medicaid Services, Cindy Mann, Deputy Administrator Director for the Centers for Medicare and Medicaid, and Dr. Gilfillan in a closing session. She said that if the transformation of American health care was a soup it would need the following ingredients: people who can overcome the culture of resistance by imagining new roles for patients, physicians, nurses, allied health professionals, employers, and government; payment such as capitation that incentivizes prevention over volume of services delivered; delivery system changes so that team work and coordination of care is emphasized across the continuum of care; culture changes so that fixed mental models of how the health care system works are challenged; technology and data so that providers can have real time evaluations of how delivery system changes are really succeeding or failing; evidence based medicine guidelines and perhaps in the future computer simulation models such as Archimedes; and strategies so that the successful changes are spread and scaled.