The Democratization of Medicine
Article first appeared in Nephrology News and Issues/ December, 2015
Genomics, point-of-care diagnostics, big data, open sourcing, and smartphones will empower patients to disrupt the paternalistic model of nephrology and dialysis
The next generation of care is here. How will it impact the practice of nephrology and the provision of dialysis services? Genomics, point-of-care diagnostics, big data, open sourcing, and smartphones will empower patients to disrupt the paternalistic model of nephrology and dialysis. This disruption has a name. It is called the “democratization of medicine.”1
Renal patients in the paternalistic model are very passive in today’s care environment. In most cases, they have little data, limited knowledge, and they experience highly fragmented care. Health care professionals are in control with little patient or family involvement. In addition, the focus of care is when the kidneys fail and the patient is on dialysis. It is also the most difficult period to improve out- comes and reduce medical costs.
This is typical of our health care system in the United States, where 80% of the dollars are spent on chronic dis- eases. Much has been written regarding a more proactive and further upstream approach, one focused on care before the kidneys fail. But how much is invested in that return? The reality is it receives little capital and attention. We are all familiar with the efforts of patient advocate organizations and some dialysis providers who invest in chronic disease care knowing there are no monetary returns. But we will not see real results until those patients, who have the genes that predispose them to co-morbid and genetic conditions that result in kidney disease, own their health data, understand their inherited genetic risks, and take responsibility for their care.
In this article, I will explore how the democratization of renal medicine can achieve preventative care with meaningful results. I will discuss renal genomics, point-of-care diagnostics and treatment, accessing and using big data, open sourcing and sharing, and patient activation and engagement. This is not intended to be a full treatment of the subject matter but to peak your interest to explore further.
Genomics: Understanding your risk
In April 2014, I attended Stanford University’s Center for Computational, Evolutionary and Human Genomics (CEHG) Genetics and Society Symposium 2015. I learned how whole-genome sequencing of a patient’s DNA can facilitate diagnosis of a disease, and its potential for guiding treatment. I learned how advances in human genome sequencing and generation of public databases of genomic diversity are enabling us to re- examine the genetics of kidney diseases.
At SNPedia, you can search for Single Nucleotide Polymorphisms (SNPs) that are identified as causative for chronic kidney disease and ESRD. SNPs are created during the making of new cells, when an existing cell divides in two. Before the cell divides in two, it copies its DNA so the new cells will each have a complete set of genetic instructions. Cells sometimes make mistakes during the copying process, much like typos. These typos lead to variations in the DNA sequence at particular locations, called SNPs.
According to SNPedia, the importance of SNPs comes from their ability to influence disease risk, drug efficacy and side effects, tell you about your ancestry, and predict aspects of how you look and even act. SNPs are probably the most important category of genetic changes influencing common diseases. And in terms of common diseases, nine of the top 10 leading causes of death have a genetic component and thus most likely one or more SNPs influence your risk.
Researchers have identified 50 SNPs for different populations and comorbid conditions associated with ESRD. The non-diabetic kidney disease prevalent in African ancestry populations is an illustrative example. Newly available genomic database information enabled research groups to discover common functional DNA sequence risk variants in the APOL1 gene.2 The definition of APOL1 nephropathy also confirms the long-held assumption by many clinicians that kidney disease attributed to hypertension in African populations represents an underlying glomerulopathy. Still awaited is the delineation of the biologic mechanisms of cellular injury related to these variants, to provide biologic proof of the APOL1 association and to provide potential targets for preventive and therapeutic intervention.
Genome-Wide Association Studies (GWAS) represent a recently developed research technique with many implications on both a global and an individual scale. GWAS seek to identify those single nucleotide polymorphisms that are common to the human genome and to determine how these polymorphisms are distributed across different populations. On a broad scale, these studies help scientists uncover associations between individual SNPs and disorders that are passed from one generation to the next in Mendelian fashion. On a small scale, GWAS can be used to determine an individual’s risk of developing a particular disorder.
If you are interested in your own GWAS, contact compa- nies such as 23&me (www.23&me.com). With a sample of your saliva, you can get your own genome raw data for less than $100. The U.S. Food & Drug Administration has not given these companies approval to give your disease risk without a physician order and at a high cost. But you can receive your own data; enter it into Stanford’s www.interp- retome.com and determine your own disease risk.
Point-of-Care diagnostics and treatment:
The virtual reality of care and treatment
Point-of-care (POC) diagnostics allows patient diagnoses in the physician’s office, in an ambulance, in a pharmacy, or in the patient’s home. The results are timely, and allow rapid treatment for the patient, significantly impacting delivery of health care.
Advanced microfluidics, digital optics, lab-on-a-chip experiments, and devices are enhancing the quality of POC diagnostics. The market for global POC diagnostics is expected to grow at a compound annual rate of around 8.4% from 2013-2018 to reach a value of $24 billion by 2018. In coming years, POC diagnostics will take over routine diagnostics as the focus shifts from curative to preventative care with enhanced patient involvement. A point-of- care diagnostic company, Cellscope, has a product that uses the iPhone as an otoscope to take a picture of the inner ear and diagnose an ear infection. Another company, AliveCor, has a smartphone application that enables patients to use their thumbs to diagnose cardiac arrhythmias such as atrial fibrillation.
On the POC treatment side, during my tenure managing an ESRD Medicare Advantage Special Needs Plan, we developed and implemented care management (CM) and medication therapy management (MTM) programs for all members. One of our more successful programs was a secure Skype communication link to teleconference the patient, nurse, and pharmacist together to reconcile and review the patient’s medications.
United Healthcare Group (UHG) announced last month that it will roll out the widest POC treatment coverage in the U.S. UHG plans to extend telemedicine coverage to up to 20 million customers in fully-insured plans by Jan. 1. (The three networks the insurer will use are Doctor On Demand, Optum’s NowClinic and American Well’s Amwell.) Walgreens has also announced plans to expand its telemedicine platform, MDLIVE, to 25 states by the end of this year. With these virtual services, patients can use their smartphones, tablets, or computer to access a live MD for basic primary care problems. It is already possible for patients to use their smart- phones, tablets, and computers to access their MDs, diagnose their conditions, and be responsible for their treatments.
There is currently a lot of venture capital invested in these companies. One interesting website is www.crunchbase.com that provides the VC investments by round and by firm. It will not be long before services and products will be developed specifically for renal patients.
Data: The more the better, but organization, patient ownership is key
Data is still the Achilles’ heel of health care––how we enter it, how we create interfaces, how we receive it, how we cleanse it, how we warehouse it, how we secure it, how we report it, and how we make it actionable. In the ideal world, the patient should own their health care data. It comes directly to them. After all, they are the rightful owner. But there are obstacles. Some of it lies with the deep-seated defense of paternalistic medicine. The typical professional response is that patients will not understand the data. The more self-serving fears are that it will lead to malpractice litigations.
Integrated delivery systems and large medical groups, such as Kaiser Permanente and Sutter Palo Alto Medical Foundation, are already providing this data to their patients. With the advent of wearable devices such as Fitbit, Jawbone, Apple watch, and others, personal health care data will become more transparent.
Your watch will tell you that you have been sitting too long or have not exercised enough. It will tell you to take your medication, show you the tablet, and confirm that you have taken it.
Open sourcing: How do we learn from each other
At the TED meeting (www.ted.com) in 2014, Google’s Larry Page declared, “Wouldn’t it be amazing to have anonymous medical records available to all research doctors? Making our medical records open for sharing will save 100,000 lives a year.” While no one is sure where Mr. Page derived his number, there are enormous potential advantages to genomic and medical data sharing. But will individuals consent to share their data even on an anonymous basis? Revelations of identity theft and the NSA/Eric Snowden incident have caused people to become more protective of their data.
Organizations such as the Kidney and Urinary Pathway Knowledge Base (KUPKB) , have been aggregating research data with the objective of identifying suitable biomarkers that could facilitate early detection and diagnosis and allow for a better understanding of the underlying renal pathology. This requires the analyses of data from multiple levels, (e.g. medical records, experimental data, genes, proteins and metabolites). One of the challenges in meeting this goal is the necessary integration of the resultant data for further analysis by data mining. Considering the challenge dialysis providers experience in interfacing dialysis center data with hospital data to identify the six co-morbid conditions for CMS dialysis bundled payment system should give us a pause.
Patient activation and engagement: The democratization of medicine
“It’s not the owner of a stage coach who builds railways.”
— Joseph Schumpeter
“The relationship between doctors and patients will surely be much more equal; indeed, health will be the business primarily of patients, with doctors as advisors, guides, and facilitators. Much of medical practice will be conducted online, with online consultations routine”
—Richard Smith, Editor, British Medical Journal
Let’s take a simple monitoring task patients can do today—monitoring blood pressure. Once the physician sets the goal parameters, such as 130/80, the patient can take over. With frequent readings and data visualization on a smartphone screen, the patient can diagnose whether control has been achieved. The alternative is to visit a physician or pharmacy on a periodic basis with all the environmental and stress-related variables that could affect the results. I have identified four smartphone applications that patients can use today to monitor their own health. They are still somewhat costly, but in time prices should decline.
Smartphone apps and your health
AliveCor’s Heart Monitor is a case that features built-in electrodes for reading and recording single-channel electrocardiogram (ECG) measurements. (ECG tests measure the electrical activity of the heart, and can help monitor and detect issues with the heart.) Once you snap the case onto your iPhone 4, 4S 5 or 6, and download the free mobile app, you can begin the test by placing your thumbs over the sensors for 10 seconds. The app then displays the reading, as well as heart rate, right on the screen. AliveCor will also securely store data in the cloud, for analysis and data sharing with the doctor. AliveCor Heart Monitor must be prescribed by a doctor and retails for $199.
Withings Smart Blood Pressure Monitor is available for the iPhone, iPad and iPod Touch. The accessory features a blood pressure cuff that attaches to your iOS device via a 30-pin connector. There is an accompanying application. Once you’ve place the band around your arm, it can measure systolic and diastolic pressure and heart rate. The application automatically saves the data, so you can access your history at any time or share with doc- tors via email. You can also create multiple profiles for each member of your family. The application also provides advice and an FAQ section about blood pressure. The Smart Blood Pressure Monitor costs $130. • iBGStar’s Blood Glucose Monitoring System for diabetes monitoring allows users to check blood glucose levels and manage data right from their mobile device. Similar to the Smart Blood Pressure Monitor, the accessory attaches to iOS devices via the 30-pin connector or Lightning adapter. It comes with a lancet device and test strips. After inserting the strip into the bottom of the accessory, blood sample can be applied, and the built-in meter will calculate test results. All data is logged in the app, and information can be shared via email. The iBGStar with 10 test strips costs around $72; the price goes up to $100 for 50 test strips.
Scanadu’s Scout isn’t about diagnosing problems on the spot. Rather, it’s about collecting data over time, so that people can keep track of changes in their health and identify when things are abnormal for them and not based on medical averages. For “Star Trek” fans, think tricorder. Created by a Silicon Valley startup, the Scanadu Scout is a small puck placed on the forehead for 10 seconds. The sensors inside measure heart rate, skin/body temperature, oxygen saturation levels, respiratory rate, blood pressure, ECG and emotional stress. Data is sent to the smartphone app (iOS or Android) via Bluetooth for analysis and tracking.
We can give patients the data, devices, education, and point of care access they need to 1) determine their genomic risk, 2) to manage their co-morbid conditions to delay CKD progression, 3) to manage the first 100 days of dialysis, 4) to differentiate the stress on the body with home versus in center dialysis, 5) to manage their 8-15 medications better, 6) to virtually access their health care professionals 24/7, and 7) to empower them to improve their clinical and financial outcomes. All of this is possible with technology and through the democratization of medicine.
Topol E. “The patient will see you now: The future of medicine is in your hands” 2015
Wasser WG1, Tzur S, Wolday D, Adu D, Baumstein D, Rosset S, Skorecki KJ. Population genetics of chronic kidney disease: the evolving story of